SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the financial statements and other documents incorporated by reference in this prospectus contain forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Many of the forward-looking statements contained in this prospectus can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and • other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectus.
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Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and supplement, including the financial statements and other documents incorporated by reference in this prospectus contain forward-looking statementsherein, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute contains forward-looking statements within the meaning of Section 27A the United States Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of applicable Canadian securities law. We refer to such forward-looking statements and forward-looking information collectively as “forward-looking statements”. These statements relate to future events or future performance and reflect our expectations and assumptions regarding our growth, results of operations, performance and business prospects and opportunities. Such forward-looking statements reflect our current beliefs and are based on information currently available to us. In some cases, forward-looking statements can be identified by terminology such as “may”, “would”, “could”, “will”, “should”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “continue” or the negative of these terms or other similar expressions concerning matters that are not historical facts. The forward-looking statements in this prospectus supplement and, including any documents incorporated by reference herein, include, among others, statements regarding our future operating results, economic performance and product development efforts and statements in respect of: • our ability to obtain the substantial capital we require to fund research and operations; • our business strategy; • our clinical development plans; • our plans to conduct clinical trials and preclinical programs; • our ability to accrue appropriate numbers and types of patients; • our reliance on external contract research/manufacturing organizations for certain activities; • our plans to secure and maintain strategic partnerships to assist in the further development of our product candidates and to build our pipeline; • our ability to file and maintain intellectual property to protect our pharmaceutical assets; • potential exposure to legal actions and potential need to take action against other entities; • our expectations regarding the progress and the successful and timely completion of the Securities Act various stages of 1933our drug discovery, drug synthesis and formulation, preclinical and clinical studies and the regulatory approval process; • our plans, objectives, expectations and intentions; and • other statements including words such as amended“anticipate”, or the Securities Act“contemplate”, “continue”, “believe”, “plan”, “estimate”, “expect”, “intend”, “will”, “should”, “may”, and Section 21E of the Exchange Actother similar expressions. Many of the The forward-looking statements contained in this prospectus can supplement and in the documents incorporated by reference reflect our current views with respect to future events, are subject to significant risks and uncertainties, and are based upon a number of estimates and assumptions that, while considered reasonable by us, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be identified materially different from any future results, performance, or achievements that may be expressed or implied by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management thatincluding, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statementsamong others: • our operation as a development stage company with lack of product revenues and net losses and a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack early stage of adequate funding to complete development of our product candidates and development, particularly the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and • other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the inherent risks and uncertainties identified above may be amplified by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of associated with (i) developing new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product drug candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectus.generally,
Appears in 1 contract
Samples: Common Shares Purchase Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the financial statements and other documents incorporated by reference in this prospectus contain forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute contains forward-looking statements within the meaning of Section 27A the federal securities laws, which statements involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or our future financial or operating performance and expectations. Any statements contained herein that are not statements of the Securities Act of 1933historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as amended“may”, “will”, “should”, “expects”, “plans”, “anticipates”, “could”, “intends”, “target”, “projects”, “contemplates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or the Securities Actnegative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Forward-looking statements contained in this prospectus include, but are not limited to, statements about: ● our future financial and results of operations; ● our growth plans; ● our business plan and our ability to effectively manage our growth; ● our ability to attract and retain brands and advertising agencies; ● the effects of increased competition in our market and our ability to compete effectively; ● our plans to use the proceeds from this offering; ● estimates of our expenses, future revenues, capital requirements, our needs for additional capital and our ability to obtain additional capital; ● our ability to attract and retain qualified directors, employees and key personnel such as our founders while maintaining our corporate culture; ● future acquisitions of or investments in complementary companies; and ● the effects of trends on, and Section 21E fluctuations in, our results of the Exchange Actoperations. Many of We have based the forward-looking statements contained in this prospectus can be identified by primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy and financial needs. The outcome of the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Readers are cautioned not to place undue reliance on events described in these forward-looking statementsstatements is subject to risks, which speak only as of their datesuncertainties, assumptions and other factors described in the section captioned “Risk Factors” and elsewhere in this prospectus. These risks are not exhaustive. Other sections of this prospectus include additional factors that could adversely impact our business and financial performance. Furthermore, new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements are based on estimates and assumptions by our management thatcontained in this prospectus. We cannot assure you that the results, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and • other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by circumstances reflected in the forward-looking statements will transpire be achieved or occur, and actual results, events or if any of them docircumstances could differ materially from those described in the forward-looking statements. In addition, what impact they will have statements that “we believe” and similar statements reflect our beliefs and opinions on our results of operations, cash flows or financial conditionthe relevant subject. Additionally, some These statements are based upon information available to us as of the risks date of this prospectus, and uncertainties identified above while we believe such information forms a reasonable basis for such statements, such information may be amplified by the COVID-19 pandemic. It is limited or incomplete, and our statements should not possible be read to predict or identify all such risks. There may be additional risks indicate that we consider immaterial have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. The forward-looking statements made in this prospectus relate only to events as of the date on which such statements are unknownmade. Except We undertake no obligation to update any forward-looking statements after the date of this prospectus or to conform such statements to actual results or revised expectations, except as required by law. As a condition to Investor’s Subscription, we the Investor represents, warrants, acknowledges and agrees that the following are under no obligationtrue as of the date written below, as of the date of Closing and which representations, warranties, and expressly disclaim covenants shall survive the Closing, and acknowledges that the Company is relying thereon, that: C-2.1. Investor is not a U.S. person, as defined in Rule 902 of Regulation S, and is not acquiring the Tokens for the account or benefit of any obligationU.S. person. C-2.2. Investor acknowledges the Company may offer the Tokens under this Rolling SAFE only to persons outside the United States and either (1) at the time any buy order is originated, the buyer must be outside the United States, or the seller and any person acting on its behalf reasonably believe that the buyer is outside the United States; or (2) the transaction is executed in, on or through a physical trading floor of an established foreign securities exchange that is located outside the United States. Accordingly, Investor was located outside of the United States when receiving and executing this Rolling SAFE, and Investor has not received an offer to updatepurchase the Tokens inside the United States and will not originate a buy order for the Tokens inside the United States. C-2.3. Investor has not received, alter and is not aware of, any advertisement in a publication with a general circulation in the United States (as defined in Rule 902 of Regulation S) that refers to the Tokens or otherwise revise any forward-looking statement, whether written the offer or oral, sale of the Tokens. Investor acknowledges that may be made from time to time, whether it is not acquiring the Tokens as a result of, any "directed selling efforts" (as defined in Rule 902 of new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness Regulation S) in the body’s own immune defenses to fight tumor cells. One United States in respect of any of the most potent cells Tokens. C-2.4. Investor understands that the Tokens are being offered and sold in reliance on the safe harbor of Regulation S under the Securities Act and any applicable state securities laws, and that the Company is relying, in part, on the truth and accuracy of, and Investor’s compliance with, the representations, warranties, and covenants set forth herein to determine the availability of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads safe harbor to the destruction Company and the eligibility of cancer cellsInvestor to acquire the Tokens. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administrationC-2.5. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectus.Investor agrees that:
Appears in 1 contract
Samples: Rolling Safe
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying prospectus and the financial statements and other documents incorporated by reference in into this prospectus supplement and the accompanying prospectus may contain “forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements ” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Many of Forward-looking statements are statements other than historical facts and relate to future events or circumstances or our future performance, and they are based on our current assumptions, expectations and beliefs concerning future developments and their potential effect on our business. These forward-looking statements include statements about, among other things, our future financial and operating performance, our future cash flows and liquidity and our growth strategies, as well as anticipated trends in our business and industry. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in this prospectus can be identified by the use Private Securities Litigation Reform Act of forward-looking words 1995. Words such as “anticipate,” “believe,” “couldestimate,” “expect,” “shouldproject,” “intend,” “may,” “plan,” “intendpredict,” “estimatebelieve,” “possible,” “should” and similar words or expressions are intended to identify forward-looking statements although not all forward- looking statements contain these identifying words. These forward-looking statements include statements about, among other things: • developments, projections and trends relating to us, our competitors and our industry; • our strategic plans for our business; • our expectations regarding the impact of the COVID-19 pandemic on our business; • our operating performance, including our ability to achieve equal or higher levels of revenue, stabilize the historical fluctuations in our performance and achieve or grow profitability; • the rate and degree of market acceptance and adoption of our genetic and clinical tests and genetic testing and clinical testing generally and other anticipated trends in our industry; • our ability to remain competitive, particularly if the testing markets continue to expand and competition becomes more acute; • our ability to continue to expand the number of genes covered by our tests and introduce other improvements to our tests; • our continued ability to offer affordable pricing for our tests, in spite of recent price degradation in the genetic testing industry, and our ability to maintain the low internal costs of our business model and record acceptable margins on our sales; • our ability to strengthen our existing base of customers by maintaining or increasing demand from these customers; • our ability to grow and diversify our customer base, including our plans to target new institutional and individual customer groups; • our reliance on a limited number of suppliers and ability to adapt to possible disruptions in their operations; • our use of our laboratory facilities and our ability to adapt in the event our facilities are damaged or rendered inoperable; • the level of success of our efforts to increase our global presence, including strengthening relationships with existing and new international customers and establishing other types of arrangements, including our joint venture in the People’s Republic of China, or PRC, or other international joint venture or distributor relationships we may pursue; • the impact on our business of our recent investments in building and restructuring our sales and marketing strategies and teams, in our recently approved tests for COVID-19, and our plans for future sales and marketing efforts; • advancements in technology by us and our competitors; • our use of technology and ability to prevent security breaches, loss of data and other disruptions; • our ability to effectively manage any growth we may experience, including expanding our infrastructure, developing increased efficiencies in our operations and hiring additional skilled personnel in order to support any such growth; • developments with respect to U.S. and foreign regulations applicable to our business, and our ability to comply with these regulations; • our ability to prevent errors in interpreting the results of our tests so as to avoid product liability and professional liability claims; • our ability to obtain and maintain coverage and adequate reimbursement for our tests and to manage the complexity of billing and collecting such reimbursement; • the state of the U.S. and foreign healthcare markets, including the role of governments in the healthcare industry generally and pressures or incentives to reduce healthcare costs while expanding individual benefits, as well as the impact of general uncertainty in the U.S. healthcare regulatory environment; • our ability to attract, retain and motivate key scientific and management personnel; • our expectations regarding our ability to obtain and maintain protection of our trade secrets and other intellectual property rights and not infringe the rights of others; • our expectations regarding our future expense levels and our ability to appropriately forecast and plan our expenses; • our expectations regarding our future capital requirements and our ability to obtain additional capital if and when needed; and • the impact of the above factors and other future events on the market price of our common stock. All forward-looking statements reflect management’s present assumptions, expectations and beliefs regarding future events and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed in or implied by any forward-looking statements. These risks and uncertainties include those described under the heading “potential,Risk Factors” among otherscontained in this prospectus, any related free writing prospectus, and in our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC. Readers In light of these risks and uncertainties, these forward-looking events and circumstances may not occur, and actual results could differ materially and adversely from those described in or implied by any forward-looking statements we make. Although we have based our forward-looking statements on assumptions and expectations we believe are cautioned reasonable, we cannot guarantee future results, levels of activity, performance or achievements or other future events. Moreover, we operate in a competitive and rapidly evolving industry and new risks emerge from time to time. It is not possible for us to predict all of the risks we may face, nor can we assess the impact of all factors on our business or the extent to which any factor or combination of factors could cause actual results to differ from our expectations. As a result, forward-looking statements should not be relied on or viewed as predictions of future events, and such forward-looking statements should be read with the understanding that actual future results, levels of activity, performance and achievements may be materially different than our current expectations. Given these risks, uncertainties and other important factors, you should not place undue reliance on these forward-looking statements. You should carefully read this prospectus, which speak only the accompanying base prospectus and any related free writing prospectus, together with the information incorporated herein and therein by reference as described under the headings “Where You Can Find More Information” and “Incorporation of their datesCertain Information By Reference,” completely and with the understanding that our actual future results may be materially different from what we expect. These forward-looking statements are based on represent our estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, only as of the factors that could cause date made. Any such forward-looking statements are not guarantees of future performance and actual results to results, developments and business decisions may differ from historical results or those anticipated or predicted contemplated by our such forward-looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due . We undertake no duty to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on update these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and • other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordinglyafter the date of this prospectus, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except except as required by law, even though our situation may change in the future. You should carefully consider other information set forth in reports or other documents that we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any file with the SEC. We qualify all of our forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered statements by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectusthese cautionary statements.
Appears in 1 contract
Samples: Equity Distribution Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the financial statements applicable prospectus supplement include and other documents incorporated incorporate by reference in this prospectus contain “forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements ” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange ActAct of 1934, as amended. Many of Forward-looking statements are statements other than historical facts and relate to future events or circumstances or our future performance, and they are based on our current assumptions, expectations and beliefs concerning future developments and their potential effect on our business. These forward- looking statements include statements about, among other things, our future financial and operating performance, our future cash flows and liquidity and our growth strategies, as well as anticipated trends in our business and industry. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in this prospectus can be identified by the use Private Securities Litigation Reform Act of forward-looking words 1995. Words such as “anticipate,” “believe,” “couldestimate,” “expect,” “shouldproject,” “intend,” “may,” “plan,” “intendpredict,” “estimatebelieve,” “possible,” “should” and similar words or expressions are intended to identify forward-looking statements although not all forward- looking statements contain these identifying words. These forward-looking statements include statements about, among other things: • developments, projections and trends relating to us, our competitors and our industry; • our strategic plans for our business; • our expectations regarding the impact of the COVID-19 pandemic on our business; • our operating performance, including our ability to achieve equal or higher levels of revenue, stabilize the historical fluctuations in our performance and achieve or grow profitability; • the rate and degree of market acceptance and adoption of our genetic and clinical tests and genetic testing and clinical testing generally and other anticipated trends in our industry; • our ability to remain competitive, particularly if the testing markets continue to expand and competition becomes more acute; • our ability to continue to expand the number of genes covered by our tests and introduce other improvements to our tests; • our continued ability to offer affordable pricing for our tests, in spite of recent price degradation in the genetic testing industry, and our ability to maintain the low internal costs of our business model and record acceptable margins on our sales; • our ability to strengthen our existing base of customers by maintaining or increasing demand from these customers; • our ability to grow and diversify our customer base, including our plans to target new institutional and individual customer groups; • our reliance on a limited number of suppliers and ability to adapt to possible disruptions in their operations; • our use of our laboratory facilities and our ability to adapt in the event our facilities are damaged or rendered inoperable; • the level of success of our efforts to increase our global presence, including strengthening relationships with existing and new international customers and establishing other types of arrangements, including our joint venture in the People’s Republic of China, or PRC, or other international joint venture or distributor relationships we may pursue; • the impact on our business of our recent investments in building and restructuring our sales and marketing strategies and teams, in our recently approved tests for COVID-19 and our plans for future sales and marketing efforts; • advancements in technology by us and our competitors; • our use of technology and ability to prevent security breaches, loss of data and other disruptions; • our ability to effectively manage any growth we may experience, including expanding our infrastructure, developing increased efficiencies in our operations and hiring additional skilled personnel in order to support any such growth; • developments with respect to U.S. and foreign regulations applicable to our business, and our ability to comply with these regulations; • our ability to prevent errors in interpreting the results of our tests so as to avoid product liability and professional liability claims; • our ability to obtain and maintain coverage and adequate reimbursement for our tests and to manage the complexity of billing and collecting such reimbursement; • the state of the U.S. and foreign healthcare markets, including the role of governments in the healthcare industry generally and pressures or incentives to reduce healthcare costs while expanding individual benefits, as well as the impact of general uncertainty in the U.S. healthcare regulatory environment; • our ability to attract, retain and motivate key scientific and management personnel; • our expectations regarding our ability to obtain and maintain protection of our trade secrets and other intellectual property rights and not infringe the rights of others; • our expectations regarding our future expense levels and our ability to appropriately forecast and plan our expenses; • our expectations regarding our future capital requirements and our ability to obtain additional capital if and when needed; and • the impact of the above factors and other future events on the market price of our common stock. All forward-looking statements reflect management’s present assumptions, expectations and beliefs regarding future events and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed in or implied by any forward-looking statements. These risks and uncertainties include those described under the heading “potential,Risk Factors” among otherscontained in the applicable prospectus supplement and any related free writing prospectus, and under similar headings in the other documents that are incorporated by reference into this prospectus, including our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC. Readers In light of these risks and uncertainties, these forward-looking events and circumstances may not occur, and actual results could differ materially and adversely from those described in or implied by any forward-looking statements we make. Although we have based our forward-looking statements on assumptions and expectations we believe are cautioned reasonable, we cannot guarantee future results, levels of activity, performance or achievements or other future events. Moreover, we operate in a competitive and rapidly evolving industry and new risks emerge from time to time. It is not possible for us to predict all of the risks we may face, nor can we assess the impact of all factors on our business or the extent to which any factor or combination of factors could cause actual results to differ from our expectations. As a result, forward- looking statements should not be relied on or viewed as predictions of future events, and such forward-looking statements should be read with the understanding that actual future results, levels of activity, performance and achievements may be materially different than our current expectations. Given these risks, uncertainties and other important factors, you should not place undue reliance on these forward-looking statements. You should carefully read this prospectus, which speak only the applicable prospectus supplement and any related free writing prospectus, together with the information incorporated herein and therein by reference as of their datesdescribed under the heading “Where You Can Find More Information,” completely and with the understanding that our actual future results may be materially different from what we expect. These forward-looking statements are based on represent our estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, only as of the factors that could cause date made. Any such forward-looking statements are not guarantees of future performance and actual results to results, developments and business decisions may differ from historical results or those anticipated or predicted contemplated by our such forward-looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due . We undertake no duty to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on update these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and • other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordinglyafter the date of this prospectus, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except except as required by law, even though our situation may change in the future. You should carefully consider other information set forth in reports or other documents that we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any file with the SEC. We qualify all of our forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered statements by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectusthese cautionary statements.
Appears in 1 contract
Samples: Equity Distribution Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying prospectus and the financial statements and other documents information incorporated by reference in this prospectus supplement and the accompanying prospectus contain “forward-looking statements,” which include information relating to future events, including statements concerning our industryfuture financial performance, our operationsstrategies, our anticipated financial performance expectations, competitive environment and financial condition, and our business plans and growth strategy and product development effortsregulation. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Many of the forward-looking statements contained in this prospectus can be identified by the use of forward-looking words Words such as “anticipatemay,” “believeshould,” “could,” “expectwould,” “shouldpredicts,” “plan,” “intend,” “estimate” and “potential,” among others. Readers are cautioned not to place undue reliance on these “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements, which speak only . Forward-looking statements should not be read as a guarantee of their datesfuture performance or results and will probably not be accurate indications of when such performance or results will be achieved. These forwardForward-looking statements are based on estimates information we have when those statements are made or our management’s good faith belief as of that time with respect to future events, and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertaintiesuncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. The following represent some, but not necessarily all, of the Important factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statementssuch differences include, but are not limited to: • our operation history of recurring losses and negative cash flows from operating activities and the uncertainty regarding the adequacy of our liquidity to pursue or complete our business objectives, and substantial doubt regarding our ability to continue as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 milliongoing concern; • the chance our results of ongoing and future clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trialsstudies; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding inability to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms successfully develop or at all to complete development and begin commercialization of commercialize our product candidates; • our dependence on the success market acceptance of AFM24 existing and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial new products; • if our product candidates obtain regulatory approvalinability to carry out research, our being subject to expensive ongoing obligations development and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenuescommercialization plans; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure inability to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical complete preclinical testing and clinical trials and on third-party, single-source suppliers to supply or produce as anticipated; • changes in our product candidatesrelationship with key collaborators; • our ability to scale-up manufacturing processes of our product candidates adequately protect and reduce the cost of manufacturing our product candidates in advance of any commercializationenforce rights to intellectual property; • our need to raise additional capital to meet our business requirements in the future growth and the difficulties in obtaining financing on commercially reasonable terms, or at all; • intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; • our inability to manufacture our PURE EP product on a commercial scale on our own or in collaborations with third parties; • entry of new competitors and products and potential technological obsolescence of our products; • effect of healthcare legislation or reform measures that may substantially change the market for medical care or healthcare coverage in the U.S.; • our failure to obtain regulatory approvals; • adverse market and economic conditions; • our ability to compete, which depends maintain the listing of our common stock on retaining our key personnel and recruiting additional qualified personnelThe Nasdaq Capital Market; • the length and severity of the COVID-19 outbreak and its impact on our business, results of operations and financial condition may be adversely impacted by public health epidemics, including our supply chain, clinical trials and operationsthe recent COVID-19 outbreak; • the impact on loss of one or more key executives; • difficulties in securing and retaining regulatory approval to market our business by political events, war, terrorism, business interruptions product and other geopolitical events and uncertainties, such as the Russia-Ukraine conflictproduct candidates; and • other risk factors discussed herein under depth of the trading market in our common stock. You should review carefully the section entitled “Risk Factors” or incorporated herein by referencebeginning on page S-6 of this prospectus supplement for a discussion of these and other risks that relate to our business and investing in our securities. Our actual results or performance could differ materially from those expressed in, or implied by, any The forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated contained or incorporated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified reference in this prospectus supplement are expressly qualified in their entirety by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknownthis cautionary statement. Except as required by applicable law, we are under no obligation, and expressly disclaim do not undertake any obligation, obligation to update, alter or otherwise revise publicly update any forward-looking statementstatement contained in this prospectus supplement, whether written the accompanying prospectus or oralthe documents incorporated by reference herein to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events. For all forward-looking statements, that we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. We have never paid cash dividends on our common stock and do not anticipate paying any cash dividends in the foreseeable future but intend to retain our capital resources for reinvestment in our business. We may be made issue and sell shares of our common stock having aggregate sales proceeds of up to $45,000,000 from time to time, whether . Because there is no minimum offering amount required as a result condition to close this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time. There can be no assurance that we will sell any shares under, or fully utilize, the sales agreement with Jefferies as a source of financing. We currently intend to use the net proceeds from this offering to support commercialization and for working capital and general corporate purposes, including expansion of PURE EP commercialization plans and anticipated expansion of Merimepodib program. We do not currently have more specific plans or commitments with respect to the net proceeds from this offering and, accordingly, are unable to quantify the allocation of such proceeds among the various potential uses. Investors will be relying on the judgment of our management, who will have broad discretion regarding the application of the proceeds of this offering. The amounts and timing of our actual expenditures will depend upon numerous factors, including the amount of cash generated by our operations, the amount of competition and other operational factors. We may find it necessary or advisable to use portions of the proceeds from this offering for other purposes. From time to time, we evaluate these and other factors and we anticipate continuing to make such evaluations to determine if the existing allocation of resources, including the proceeds of this offering, is being optimized. Circumstances that may give rise to a change in the use of proceeds include: ● a change in development plan or strategy; ● the addition of new informationproducts or applications; ● technical delays; ● delays or difficulties with our clinical trials; ● negative results from our clinical trials; ● difficulty obtaining U.S. Food and Drug Administration approval; and ● the availability of other sources of cash including additional offerings, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectusif any.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the financial statements and other documents incorporated by reference in this prospectus contain forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute supplement contains forward-looking statements within the meaning of Section 27A that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act1995. Many of the forward-looking statements contained in this prospectus can be identified by the use of forward-looking The words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “believeintend,” “couldplan,” “expect,” “shouldpredict,” “plan,” “intend,” “estimate” and “potential,” among others. Readers “opportunity,” “goals,” or “should,” and similar expressions are cautioned not intended to place undue reliance on these identify forward-looking statements. All statements contained in this prospectus supplement, other than statements of historical fact are forward-looking statements. You should not unduly rely on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, some of which are beyond our control. These risks, uncertainties and other factors may cause our actual results, performance or achievements to be materially different from the anticipated future results, performance or achievements expressed or implied by the forward-looking statements. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, statements relating to: • our integration efforts following the acquisition of Private Viridian (as defined below); • our future research and development activities, including clinical testing and the costs and timing thereof; • our strategy, including clinical development of VRDN-001 and other product candidates, and the clinical and commercial potential of our product candidates, if approved; • the sufficiency of our cash resources; • our ability to raise additional funding when needed; • any statements concerning anticipated regulatory activities or licensing or collaborative arrangements; • business interruptions resulting from the COVID-19 outbreak or similar public health crises, which speak only as could cause a disruption in the development of their datesour product candidates and adversely impact our business; • our research and development and other expenses; • our operations and legal risks; • our ability to maintain our listing on a national securities exchange; and • any statement of assumptions underlying any of the foregoing. These forward-looking statements are based on estimates involve known and assumptions by our management thatunknown risks, although we believe to be reasonable, are inherently uncertain uncertainties and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the other factors that could may cause our actual results to differ be materially different from historical results the anticipated future results, performance or those anticipated achievements expressed or predicted implied by our any forward-looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from factors described under the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and • other risk factors discussed herein under heading “Risk Factors” or incorporated herein in this prospectus supplement and the accompanying prospectus, and the risk factors and cautionary statements described in other documents that we file from time to time with the SEC, specifically under the heading “Item 1A. Risk Factors” and elsewhere in our most recent Annual Report on Form 10-K for the year ended December 31, 2020 that was filed with the SEC on March 26, 2021. You should evaluate all forward-looking statements made in this prospectus supplement and the accompanying prospectus, including the documents we incorporate by reference, in the context of these risks, uncertainties and other factors. Our actual results We caution you that the risks, uncertainties and other factors referred to above may not contain all of the risks, uncertainties and other factors that are important to you. In addition, we cannot assure you that we will realize the results, benefits or performance could differ materially from those expressed indevelopments that we expect or anticipate or, even if substantially realized, that they will result in the consequences or implied byaffect us or our business in the way expected. All forward-looking statements in this prospectus supplement and the accompanying prospectus, including the documents we incorporate by reference, apply only as of the date made and are expressly qualified in their entirety by the cautionary statements included in this prospectus supplement and the accompanying prospectus. We undertake no obligation to publicly update or revise any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future reflect subsequent events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectuscircumstances.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the financial statements and other documents incorporated by reference in this prospectus supplement contain forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Many of the forward-looking statements contained in this prospectus supplement can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “will,” “estimate” and “potential,” among others. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 20212022, our accumulated deficit was €333.4 430.2 million; • the chance possibility that our clinical trials may be delayed or put on clinical hold, ; for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM13 and AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidatescandidates including AFM28, each of which may eventually prove to be unsuccessful or commercially not viableexploitable; • the success of the Affimed-Artiva partnership, including in relation to the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Xxxxxxxx Cancer Center, as opposed to AB-101, which is a cryopreserved allogeneic cord blood-derived NK cell that we anticipate will be co-administered with AFM13; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding regarding, acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become in the commercial productsstage; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLSNKGen Biotech, Roivant, Artiva, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), Genentech and the potential failure to enter into new strategic relationshipsrelationships or difficulties with our strategic partners that may slow the progress of our joint development or lead to the termination of a partnership and the need to enter into a new one, all of which could take substantial time and attention of our management team; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, party single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak pandemic and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by of macroeconomic trends, political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflictconflict and the instability in the banking sector experienced in the first quarter of 2023; and • other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them dodo so, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectus.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the financial statements and other documents incorporated by reference in this prospectus contain forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, that involve risks and Section 21E of the Exchange Actuncertainties. Many of the The forward-looking statements are contained principally in this prospectus “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” In some cases, you can be identified by the use of identify forward-looking words statements by terms such as “anticipatemay,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “couldanticipate,” “expectproject,” “shouldtarget,” “design,” “estimate,” “predict,” “potential,” “plan,” “intend,” “estimate” or the negative of these terms, and “potential,” among otherssimilar expressions intended to identify forward-looking statements. Readers These statements reflect our current views with respect to future events and are cautioned based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forwardForward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent someinclude, but are not necessarily alllimited to, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statementsstatements about: • the timing of enrollment, commencement and completion of our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 millionclinical trials; • the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful timing and clinical results may not reflect results seen in previously conducted success of preclinical studies and clinical trials, or expectations based on these preclinical studies trials conducted by us and clinical trialsour development partners; • the ability to obtain and maintain regulatory approval of our reliance on contract manufacturers clinical trials and contract research organizations over which we have limited controlproduct candidates, and the labeling for any approved products; • the scope, progress, expansion, and costs of developing and commercializing our lack product candidates; • the size and growth of adequate funding to complete development of the potential markets for our product candidates and the risk we may be unable ability to access serve those markets; • our expectations regarding our expenses and revenue, the sufficiency of our cash resources and needs for additional capital on reasonable terms or at all to complete development financing; • the rate and begin commercialization degree of market acceptance of any of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viableexpectations regarding competition; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercializedanticipated growth strategies; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenuesattract or retain key personnel; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva ability to establish and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationshipsmaintain development partnerships; • our reliance on third parties expectations regarding federal, state and foreign regulatory requirements; • regulatory developments in the United States and foreign countries; • our ability to conduct our nonclinical obtain and clinical trials and on third-party, single-source suppliers to supply or produce maintain intellectual property protection for our product candidates; • our ability to scale-up manufacturing processes of our product candidates the anticipated trends and reduce the cost of manufacturing our product candidates challenges in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflictmarket in which we operate; and • other risk factors discussed herein under “Risk Factors” the use or incorporated herein by referencesufficiency of our cash or cash equivalents. Our actual results or performance could differ materially from those expressed in, or implied by, any forwardForward-looking statements relating involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to those matters. Accordinglybe materially different from any future results, no assurances can be given that any of the events anticipated performances or achievements expressed or implied by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on our results of operations, cash flows or financial conditionstatements. Additionally, some Any forward-looking statement made by us in this prospectus speaks only as of the risks and uncertainties identified above may be amplified by the COVID-19 pandemic. It date on which it is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknownmade. Except as required by law, we assume no obligation to update these statements publicly, or to update the reasons actual results could differ materially from those anticipated in these statements, even if new information becomes available in the future. We discuss many of these risks in this prospectus in greater detail under the heading “Risk Factors.” Also, these forward-looking statements represent our estimates and assumptions only as of the date of this prospectus. Unless required by United States federal securities laws, we do not intend to update any of these forward-looking statements to reflect circumstances or events that occur after the statement is made. You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. This prospectus includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe these industry publications and third-party research, surveys and studies are under reliable, we have not independently verified such data. All written and verbal forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. We caution investors not to rely too heavily on the forward-looking statements we make or that are made on our behalf. We undertake no obligation, and expressly disclaim specifically decline any obligation, to update, alter update or otherwise revise publicly any forward-looking statement, whether written or oral, that may be made from time to timestatements, whether as a result of new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cellsIn addition, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads you should refer to the destruction section of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action this prospectus entitled “Risk Factors” as well as the preclinical and clinical data documents we have generated incorporated by reference for a discussion of other important factors that may cause our actual results to datediffer materially from those expressed or implied by our forward-looking statements. As a result of these factors, we believe cannot assure you that our product candidates as monotherapy or the forward-looking statements in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the common shares inaccuracy may be material. In light of Affimed N.V. The offices of Affimed N.V. are located the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectusall.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and accompanying prospectus and the financial statements and other documents information incorporated by reference in this prospectus supplement and accompanying prospectus contain “forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements ” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which include information relating to future events, future financial performance, strategies, expectations, competitive environment and regulation. Many of the forward-looking statements contained in this prospectus can be identified by the use of forward-looking words Words such as “anticipatemay,” “believeshould,” “could,” “expectwould,” “shouldpredicts,” “plan,” “intend,” “estimate” and “potential,” among others“continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements. Readers Forward-looking statements should not be read as a guarantee of future performance or results and will probably not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information we have when those statements are made or our management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to: ● our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; ● our ability to complete clinical trials as anticipated and obtain and maintain regulatory approvals for our products; ● our ability to adequately protect our intellectual property; ● disputes over ownership of intellectual property; ● our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; ● the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our products are an attractive alternative to other procedures and products; ● intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; ● entry of new competitors and products and potential technological obsolescence of our products; ● loss of a key customer or supplier; ● adverse economic conditions; ● adverse federal, state and local government regulation, in the United States; ● price increases for supplies and components; ● inability to carry out research, development and commercialization plans; and ● loss or retirement of key executives and research scientists. Although we believe that the forward-looking statements contained herein are reasonable, we can give no assurance that our expectations will be met. All forward-looking statements contained herein are expressly qualified in their entirety by this cautionary statement and the risk factors beginning on page S-3 of this prospectus supplement. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their datesthe date of this prospectus supplement. These Except to the extent required by applicable laws and regulations, we undertake no obligation to update these forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and • other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness circumstances after the body’s own immune defenses to fight tumor cells. One date of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer or to reflect the common shares occurrence of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectusunanticipated events.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the financial statements applicable prospectus supplement include and other documents incorporated incorporate by reference in this prospectus contain “forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute .” We intend these forward-looking statements within to be covered by the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Many of the forward-safe harbor provisions for forward looking statements contained in this prospectus can be identified by the use Private Securities Litigation Reform Act of forward-looking words 1995. Words such as “anticipate,” “believe,” “couldestimate,” “expect,” “shouldproject,” “intend,” “may,” “plan,” “intendpredict,” “estimatebelieve,” “possible,” “should” and similar words or expressions are intended to identify forward looking statements although not all forward- looking statements contain these identifying words. These forward looking statements include statements about, among other things: • developments, projections and trends relating to us, our competitors and our industry; • our strategic plans for our business; • our operating performance, including our ability to achieve equal or higher levels of revenue, stabilize the historical fluctuations in our performance and achieve or grow profitability; • the rate and degree of market acceptance and adoption of our tests and genetic testing generally and other anticipated trends in our industry; • our ability to remain competitive, particularly if the genetic testing market continues to expand and competition becomes more acute; • our ability to continue to expand the number of genes covered by our tests and introduce other improvements to our tests; • our continued ability to offer affordable pricing for our tests, in spite of recent price degradation in our industry, and our ability to maintain the low internal costs of our business model and record acceptable margins on our sales; • our ability to strengthen our existing base of hospital and medical institution customers by maintaining or increasing demand from these customers; • our ability to grow and diversify our customer base, including our plans to target new institutional and individual customer groups; • our reliance on a limited number of suppliers and ability to adapt to possible disruptions in their operations; • our use of our sole laboratory facility and ability to adapt in the event it is damaged or rendered inoperable; • the level of success of our efforts to increase our global presence, including strengthening relationships with existing and new international customers and establishing other types of arrangements, including our joint venture in the People’s Republic of China, or PRC, or other international joint venture or distributor relationships we may pursue; • the impact on our business of our recent investments in building and restructuring our sales and marketing strategies and teams, and our plans for future sales and marketing efforts; • advancements in technology by us and our competitors; • our use of technology and ability to prevent security breaches, loss of data and other disruptions; • developments with respect to U.S. and foreign regulations applicable to our business, and our ability to comply with these regulations; • our ability to prevent errors in interpreting the results of our tests so as to avoid product liability and professional liability claims; • our ability to obtain and maintain coverage and adequate reimbursement for our tests and to manage the complexity of billing and collecting such reimbursement; • the state of the U.S. and foreign healthcare markets, including the role of governments in the healthcare industry generally and pressures or incentives to reduce healthcare costs while expanding individual benefits, as well as the impact of general uncertainty in the U.S. healthcare regulatory environment following the results of the 2016 U.S. presidential election; • our ability to attract, retain and motivate key scientific and management personnel; • our expectations regarding our ability to obtain and maintain protection of our trade secrets and other intellectual property rights and not infringe the rights of others; • our expectations regarding our future expense levels and our ability to appropriately forecast and plan our expenses; • our expectations regarding our future capital requirements and our ability to obtain additional capital if and when needed; and • the impact of the above factors and other future events on the market price of our common stock. All forward-looking statements reflect management’s present assumptions, expectations and beliefs regarding future events and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed in or implied by any forward-looking statements. These risks and uncertainties include those described under the heading “potential,Risk Factors” among otherscontained in this prospectus, any related free writing prospectus, and in our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC. Readers are cautioned Given these risks, uncertainties and other important factors, you should not to place undue reliance on these forward-looking statements. You should carefully read this prospectus, which speak only the accompanying base prospectus and any related free writing prospectus, together with the information incorporated herein and therein by reference as of their datesdescribed under the heading “Where You Can Find More Information,” completely and with the understanding that our actual future results may be materially different from what we expect. These forward-looking statements are based on represent our estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, only as of the factors that could cause date made. Any such forward looking statements are not guarantees of future performance and actual results to results, developments and business decisions may differ from historical results or those anticipated or predicted contemplated by our forward-such forward looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due . We undertake no duty to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on update these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and • other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordinglyafter the date of this prospectus, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except except as required by law, even though our situation may change in the future. You should carefully consider other information set forth in reports or other documents that we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any file with the SEC. We qualify all of our forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered statements by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectusthese cautionary statements.
Appears in 1 contract
Samples: Equity Distribution Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus, each prospectus supplement and the financial statements and other documents information incorporated by reference in this prospectus and each prospectus supplement contain “forward-looking statements,” which include information relating to future events, including statements concerning our industryfuture financial performance, our operationsstrategies, our anticipated financial performance expectations, competitive environment and financial condition, and our business plans and growth strategy and product development effortsregulation. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Many of the forward-looking statements contained in this prospectus can be identified by the use of forward-looking words Words such as “anticipatemay,” “believeshould,” “could,” “expectwould,” “shouldpredicts,” “plan,” “intend,” “estimate” and “potential,” among others. Readers are cautioned not to place undue reliance on these “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements, which speak only . Forward-looking statements should not be read as a guarantee of their datesfuture performance or results and will probably not be accurate indications of when such performance or results will be achieved. These forward-Forward- looking statements are based on estimates information we have when those statements are made or our management’s good faith belief as of that time with respect to future events, and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors uncertainties that could cause actual performance or results to differ from historical results or those anticipated or predicted by our forward-looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and • other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, in or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated suggested by the forward-looking statements will transpire or occurstatements. Important factors that could cause such differences include, or if any but are not limited to: ● our history of them do, what impact they will have on our results of operations, recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; ● our ability to complete clinical trials as anticipated and obtain and maintain regulatory approvals for our products; ● our ability to adequately protect our intellectual property; ● disputes over ownership of intellectual property; ● the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our products is an attractive alternative to other products; ● intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; ● entry of new competitors and products and potential technological obsolescence of our products; ● loss of a key customer or financial conditionsupplier; ● technical problems with our research and products and potential product liability claims; ● adverse economic conditions; ● adverse federal, state and local government regulation, in the United States; ● price increases for supplies; ● inability to carry out research, development and commercialization plans; and ● loss or retirement of key executives and research scientists. Additionally, some You should review carefully the section entitled “Risk Factors” beginning on page S-9 of the risks this prospectus for a discussion of these and uncertainties identified above may be amplified by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional other risks that we consider immaterial relate to our business and investing in our securities. The forward-looking statements contained or which incorporated by reference in this prospectus or any prospectus supplement are unknownexpressly qualified in their entirety by this cautionary statement. Except as required by law, we are under no obligation, and expressly disclaim We do not undertake any obligation, obligation to update, alter or otherwise revise publicly update any forward-looking statement, whether written or oral, that may be made from time statement to time, whether as a result of new information, future reflect events or otherwise. We are a clinical-stage immuno-oncology company focused circumstances after the date on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach which any such statement is made or to cancer treatment that seeks to harness reflect the body’s own immune defenses to fight tumor cells. One occurrence of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectusunanticipated events.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectus and the financial statements and other documents incorporated by reference herein contain forward- looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management's judgment regarding future events. In many cases, you can identify forward- looking statements by terminology such as "may," "will," "should," "plan," "expect," "anticipate," "estimate," "predict," "intend," "potential" or "continue" or the negative of these terms or other words of similar import, although some forward-looking statements are expressed differently. All statements other than statements of historical fact included in this prospectus contain supplement, the accompanying prospectus and the documents incorporated by reference herein regarding our financial position, business strategy and plans or objectives for future operations are forward-looking statements. We cannot guarantee the accuracy of forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, you should be aware that results and our business plans events could differ materially and growth strategy and product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Many of adversely from those described in the forward-looking statements contained due to a number of factors. There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward- looking statement made by us. These factors include, but are not limited to: • our ability to achieve profitability by increasing sales of our laboratory tests and services and to continually develop and commercialize novel and innovative genomic-based diagnostic tests and services for cancer patients; • our ability to raise additional capital to meet our liquidity needs; • our ability to clinically validate our pipeline of genomic microarray tests currently in development; • our ability to execute on our marketing and sales strategy for our genomic tests and gain acceptance of our tests in the market; • our ability to keep pace with rapidly advancing market and scientific developments; • our ability to satisfy U.S. (including FDA) and international regulatory requirements with respect to our tests and services, many of which are new and still evolving; • our ability to obtain reimbursement from governmental and other third-party payors for our tests and services; • competition from clinical laboratory services companies, genomic-based diagnostic tests currently available or new tests that may emerge; • our ability to maintain our clinical collaborations and enter into new collaboration agreements with highly regarded organizations in the cancer field so that, among other things, we have access to thought leaders in the field and to a robust number of samples to validate our genomic tests; • our ability to maintain our present customer base and obtain new customers; • potential product liability or intellectual property infringement claims; • our dependency on third-party manufacturers to supply or manufacture our products; • our ability to manage significant fluctuations in our quarterly operating results, which may occur as a result of the timing, size and duration of our contracts with biopharmaceutical companies and clinical research organizations; • our ability to attract and retain a sufficient number of scientists, clinicians, sales personnel and other key personnel with extensive experience in oncology, who are in short supply; • our ability to obtain or maintain patents or other appropriate protection for the intellectual property in our proprietary tests and services; • our dependency on the intellectual property licensed to us or possessed by third parties; • our ability to expand internationally and launch our tests in emerging markets, such as India and Brazil; and • our ability to adequately support future growth. You should also consider carefully the statements set forth in the section titled "Risk Factors" or elsewhere in this prospectus can be identified supplement, the accompanying prospectus and the documents incorporated or deemed incorporated herein or therein by reference, including but not limited to the use risk factors incorporated by reference under "Item 1A. Risk Factors" to Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and other factors described elsewhere in this prospectus supplement or in our current and future filings with the SEC, which address various factors that could cause results or events to differ from those described in the forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” statements. All subsequent written and “potential,” among othersoral forward-looking statements attributable to us or to persons acting on our behalf are expressly qualified in their entirety by the applicable cautionary statements. Readers are cautioned not We have no plans to place undue reliance on update these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and • other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectus.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying prospectus and the financial statements and other documents information incorporated by reference in this prospectus supplement and the accompanying prospectus contain “forward-looking statements,” which include information relating to future events, including statements concerning our industryfuture financial performance, our operationsstrategies, our anticipated financial performance expectations, competitive environment and financial condition, and our business plans and growth strategy and product development effortsregulation. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Many of the forward-looking statements contained in this prospectus can be identified by the use of forward-looking words Words such as “anticipatemay,” “believeshould,” “could,” “expectwould,” “shouldpredicts,” “plan,” “intend,” “estimate” and “potential,” among others. Readers are cautioned not to place undue reliance on these “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements, which speak only . Forward-looking statements should not be read as a guarantee of their datesfuture performance or results and may not be accurate indications of when such performance or results will be achieved. These forwardForward-looking statements are based on estimates information we have when those statements are made or our management’s good faith belief as of that time with respect to future events, and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertaintiesuncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. The following represent some, but not necessarily all, of the Important factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statementssuch differences include, but are not limited to: • our operation history of recurring losses and negative cash flows from operating activities and the uncertainty regarding the adequacy of our liquidity to pursue or complete our business objectives, and substantial doubt regarding our ability to continue as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 milliongoing concern; • the chance our results of ongoing and future clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trialsstudies; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding inability to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms successfully develop or at all to complete development and begin commercialization of commercialize our product candidates; • our dependence on the success market acceptance of AFM24 existing and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial new products; • if our product candidates obtain regulatory approvalinability to carry out research, our being subject to expensive ongoing obligations development and continued regulatory oversightcommercialization plans; • enacted delays in any phase of the preclinical or clinical development of a product, including during its research and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenuesdevelopment; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure inability to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical complete preclinical testing and clinical trials and on third-party, single-source suppliers to supply or produce as anticipated; • changes in our product candidatesrelationship with key collaborators; • our ability to scale-up manufacturing processes of our product candidates adequately protect and reduce the cost of manufacturing our product candidates in advance of any commercializationenforce rights to intellectual property; • our need to raise additional capital to meet our business requirements in the future growth and ability the difficulties in obtaining financing on commercially reasonable terms, or at all; • intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; • our inability to compete, which depends manufacture our PURE EP product on retaining a commercial scale on our key personnel own or in collaborations with third parties; • entry of new competitors and recruiting additional qualified personnelproducts and potential technological obsolescence of our products; • effect of healthcare legislation or reform measures that may substantially change the market for medical care or healthcare coverage in the U.S.; • the length and severity of the ongoing COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operationspandemic; • our failure to obtain regulatory approvals; • adverse market and economic conditions; • our ability to maintain the impact listing of our common stock on the Nasdaq Capital Market; • loss of one or more key executives; • difficulties in securing and retaining regulatory approval to market our business by political events, war, terrorism, business interruptions product and other geopolitical events and uncertainties, such as the Russia-Ukraine conflictproduct candidates; and • other risk factors discussed herein under depth of the trading market in our common stock. You should review carefully the section entitled “Risk Factors” or incorporated herein by referencebeginning on page S-3 of this prospectus supplement for a discussion of these and other risks that relate to our business and investing in our securities. Our actual results or performance could differ materially from those expressed in, or implied by, any The forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated contained or incorporated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified reference in this prospectus supplement are expressly qualified in their entirety by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknownthis cautionary statement. Except as required by applicable law, we are under no obligation, and expressly disclaim do not undertake any obligation, obligation to update, alter or otherwise revise publicly update any forward-looking statementstatement contained in this prospectus supplement, whether written the accompanying prospectus or oralthe documents incorporated by reference herein to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events. For all forward-looking statements, that may we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. We have never paid cash dividends on our common stock and do not anticipate paying any cash dividends in the foreseeable future but intend to retain our capital resources for reinvestment in our business. Any future determination to declare dividends will be made from time to timeat the discretion of our board of directors and will depend on our financial condition, whether as a result operating results, capital requirements, general business conditions and other factors that our board of new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapiesdirectors may deem relevant. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads pay dividends is presently restricted pursuant to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number terms of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectusSeries C Preferred Stock.
Appears in 1 contract
Samples: Atm Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the financial statements and other documents incorporated by reference in this prospectus contain forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute contains forward-looking statements within the meaning of Section 27A the federal securities laws, which statements involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or our future financial or operating performance and expectations. Any statements contained herein that are not statements of the Securities Act of 1933historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as amended“may”, “will”, “should”, “expects”, “plans”, “anticipates”, “could”, “intends”, “target”, “projects”, “contemplates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or the Securities Actnegative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Forward-looking statements contained in this prospectus include, but are not limited to, statements about: ● our future financial and results of operations; ● our growth plans; ● our business plan and our ability to effectively manage our growth; ● our ability to attract and retain brands and advertising agencies; ● the effects of increased competition in our market and our ability to compete effectively; ● our plans to use the proceeds from this offering; ● estimates of our expenses, future revenues, capital requirements, our needs for additional capital and our ability to obtain additional capital; ● our ability to attract and retain qualified directors, employees and key personnel such as our founders while maintaining our corporate culture; ● future acquisitions of or investments in complementary companies; and ● the effects of trends on, and Section 21E fluctuations in, our results of the Exchange Actoperations. Many of We have based the forward-looking statements contained in this prospectus can be identified by primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy and financial needs. The outcome of the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Readers are cautioned not to place undue reliance on events described in these forward-looking statementsstatements is subject to risks, which speak only as of their datesuncertainties, assumptions and other factors described in the section captioned “Risk Factors” and elsewhere in this prospectus. These risks are not exhaustive. Other sections of this prospectus include additional factors that could adversely impact our business and financial performance. Furthermore, new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements are based on estimates and assumptions by our management thatcontained in this prospectus. We cannot assure you that the results, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and • other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by circumstances reflected in the forward-looking statements will transpire be achieved or occur, and actual results, events or if any of them docircumstances could differ materially from those described in the forward-looking statements. In addition, what impact they will have statements that “we believe” and similar statements reflect our beliefs and opinions on our results of operations, cash flows or financial conditionthe relevant subject. Additionally, some These statements are based upon information available to us as of the risks date of this prospectus, and uncertainties identified above while we believe such information forms a reasonable basis for such statements, such information may be amplified by the COVID-19 pandemic. It is limited or incomplete, and our statements should not possible be read to predict or identify all such risks. There may be additional risks indicate that we consider immaterial have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. The forward-looking statements made in this prospectus relate only to events as of the date on which such statements are unknownmade. Except We undertake no obligation to update any forward-looking statements after the date of this prospectus or to conform such statements to actual results or revised expectations, except as required by law. As a condition to Investor’s Subscription, we the Investor represents, warrants, acknowledges and agrees that the following are under no obligationtrue as of the date written below, as of the date of Closing and which representations, warranties, and expressly disclaim any obligationcovenants shall survive the Closing, and acknowledges that the Company is relying thereon, that: C-1.01. The Tokens being acquired by the Investor pursuant to updatethis Rolling SAFE are not being registered under the Securities Act of 1933, alter as amended (the "Securities Act"), and applicable state securities laws in reliance upon exemptions from registration, and the Tokens cannot be sold, transferred or otherwise revise any forward-looking statementdisposed of by the Investor unless they are subsequently registered under the Securities Act and applicable state securities laws, whether written or oral, that may be made an exemption from such registration is available at the time to time, whether as a result of new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells desired sale. Therefore, the Investor must bear the economic risk of the human defense arsenal are types an investment in such Tokens for an indefinite period. The Investor has no right to require registration under federal or state securities laws of white blood cells called innate immune cells (Natural Killer cells, or NK cellssuch Tokens, and macrophages)there is no assurance that any trading market in such Tokens will develop. Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platformThe Investor will not attempt to assign or otherwise transfer all or any portion of such Tokens except in accordance with federal and state securities laws. C-1.02. The Investor is acquiring such Tokens solely for investment for such Investor's own account and has no agreement, we develop proprietaryunderstanding or arrangement to subdivide, next-generation bispecific antibodiessell, so-called innate cell engagersassign, which are designed transfer or otherwise dispose of all or any part of such Tokens to any other person. No other person has or will have a direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have or indirect beneficial interest in the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads Tokens, except as disclosed to the destruction of cancer cellsCompany on an attachment hereto. Due To the extent any other person has any such beneficial interest, the Company will require such persons to their novel tetravalent architecture with four binding domains, our innate cell engagers bind execute a signature page to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectusRolling SAFE.
Appears in 1 contract
Samples: Rolling Safe
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the financial statements and other documents incorporated by reference in this prospectus contain forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute report contains forward-looking statements within the meaning of Section 27A the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be preceded by, followed by or include the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates” or similar expressions. These statements are based on the beliefs and assumptions of our management. Generally, forward-looking statements include information concerning our possible or assumed future actions, events or results of operations. Forward-looking statements specifically include, without limitation, the information herein regarding: projections; efficiencies/cost avoidance; cost savings; income and margins; earnings per share; growth; economies of scale; combined operations; the economy; future economic performance; conditions to, and the timetable for, completing the transactions; capital expenditures; future financing needs; future acquisitions and dispositions; litigation; potential and contingent liabilities; management’s plans; and merger and integration-related expenses. Although we believe that the expectations reflected in the forward-looking statements are based on reasonable assumptions, these forward-looking statements are subject to numerous factors, risks and uncertainties that could cause actual outcomes and results to be materially different from those projected. We cannot guarantee future results, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the Securities Act of 1933, as amended, forward-looking statements. All written and oral forward-looking statements made in connection with this report that are attributable to us or the Securities Act, persons acting on our behalf are expressly qualified in their entirety by “Risk Factors” and Section 21E of the Exchange Actother cautionary statements included herein. Many We are under no duty to update any of the forward-looking statements after the date hereof to conform such statements to actual results or to changes in our expectations. The information contained herein is not a complete description of our business or the risks associated with an investment in this prospectus our notes. There can be identified by no assurance that other factors will not affect the use accuracy of these forward-looking words statements or that our actual results will not differ materially from the results anticipated in such as forward-looking statements. While it is impossible to identify all such factors, factors that could cause actual results to differ materially from those estimated by us include, but are not limited to, those factors or conditions described under “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimateRisk Factors” and “potential,” among othersthe following: • the cyclicality of the aerospace market and the level of new commercial aircraft orders; • customer concentration; • production rates for various commercial and military aircraft programs; • the level of U.S. defense spending; • competitive pricing pressures; • manufacturing inefficiencies; • start-up costs and possible overruns on new contracts; • technology and product development risks and uncertainties; • product performance; • increasing consolidation of customers and suppliers in the aerospace industry; • price erosion within the electronics manufacturing services marketplace; • the risk of environmental liabilities; • possible goodwill impairment; • compliance with applicable regulatory requirements and changes in regulatory requirements, including regulatory requirements applicable to government contracts and sub-contracts; • imposition of taxes, export controls, tariffs, embargoes and other trade restrictions; • economic and geopolitical developments and conditions; • our ability to service our substantial indebtedness; • our ability to manage and otherwise comply with our covenants with respect to our significant outstanding indebtedness; • unfavorable developments in the global credit markets, which may make it more difficult to incur new indebtedness or refinance our outstanding indebtedness; • the risk that XxXxxxx’x business, operations and employees will not be integrated successfully with our business and operations; • our inability to recognize the benefits of the Merger, including any potential synergies, growth, cost savings or accretive value; • our ability to retain key employees following the Merger; • our inability to maintain current customer and supplier relationships following the Merger; • the risk that the Merger disrupts current plans and operations; • litigation in respect of either XxXxxxx, the Merger or us; • the amount of the costs, fees, expenses and charges related to the Merger and the financings for the Merger, including the notes offering; • the method of accounting for the Merger; and • risks associated with other acquisitions and dispositions of businesses by us. Readers are cautioned not to place We caution the reader that undue reliance should not be placed on these any forward-looking statements, which speak only as of their datesthe date hereof. These We do not undertake any duty or responsibility to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect actual outcomes. Ducommun provides engineering and manufacturing services primarily to the aerospace and defense industry. We design, engineer and manufacture mission-critical aerostructure and electromechanical components and subassemblies. We also provide engineering, technical and program management services. Our products and services are based used on estimates domestic and assumptions by foreign commercial and military aircraft, helicopter, missile and space programs. We are the successor to a business that was founded in California in 1849 and reincorporated in Delaware in 1970. On April 3, 2011, we entered into a Merger Agreement to acquire XxXxxxx for approximately $338.1 million comprised of approximately $310.3 million in equity and $27.8 million of outstanding XxXxxxx debt, which will be repaid at closing of the Merger. XxXxxxx provides custom high-performance electronic, electromechanical and interconnect systems on a contractual basis for customers in the aerospace and defense and several other markets. We believe our management thatacquisition of XxXxxxx (the “XxXxxxx Acquisition”) will allow us to significantly expand our existing presence in the aerospace and defense industry as well as to diversify our net sales base across new markets, although we believe including industrial, natural resources and medical. Pursuant to be reasonablethe Merger Agreement, are inherently uncertain and subject to the satisfaction of certain conditions, Merger Sub will be merged with and into XxXxxxx, with XxXxxxx (which will be renamed Xxxxxxxx XxXxxxx Technologies, Inc.) continuing as the surviving corporation and a number wholly-owned subsidiary of risks Ducommun. In the Merger, each outstanding share of XxXxxxx common stock will be cancelled and uncertaintiesconverted (subject to the exercise of appraisal rights) into the right to receive $19.25 per share in cash. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed to costly and damaging liability claims resulting proceeds from the testing of our product candidates in notes offered, together with borrowings under the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject New Credit Facilities will be used to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce finance the cost of manufacturing the XxXxxxx Acquisition, refinance certain existing indebtedness of Ducommun and XxXxxxx, pay fees and expenses in connection with the Transactions and add new cash to our product candidates balance sheet. Incorporated in advance of any commercialization; • our future growth and ability to compete1968, XxXxxxx provides EMS services, which depends on retaining our key personnel involves the manufacture of custom, complex, high-reliability and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertaintiesmission-critical products for customers in diverse technology-driven markets, such as the Russia-Ukraine conflict; aerospace and • defense, industrial, natural resources, medical and other risk factors discussed herein under “Risk Factors” or incorporated herein by referencecommercial markets. Our actual results or performance could differ materially from those expressed inXxXxxxx markets its services to customers desiring a manufacturing and engineering partner capable of developing and providing products that can perform reliably in harsh environmental conditions, or implied bysuch as extreme temperatures, any forward-looking statements relating to those matterssevere shock and vibration and with rapid turnaround time. Accordingly, no assurances can be given that any The sophistication and complexity of the events anticipated by products XxXxxxx designs and manufactures require superior quality. XxXxxxx is capable of quickly producing multiple sophisticated electronics products utilizing the forwardsame manufacturing set up resulting in increased efficiency and higher margins as compared to less-looking statements will transpire or occursophisticated high-volume product lines. This low-volume and high-mix production expertise, or if any of them dotogether with its lean manufacturing culture and service driven business model, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the COVID-19 pandemic. It is not possible enables XxXxxxx to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, consistently achieve attractive profit margins relative to update, alter or otherwise revise any forward-looking statement, whether written or oral, other industry participants that may be made from time focus on high-volume and low-mix products. For the twelve months ended April 3, 2011, on a stand-alone basis, XxXxxxx generated net sales of $332.5 million and Adjusted EBITDA of $41.0 million. See “Summary Consolidated Historical Financial Data of XxXxxxx” for a reconciliation of net income to timeAdjusted EBITDA. As of April 3, whether as 2011, on a result stand-alone basis XxXxxxx had firm backlog of new information, future events or otherwise. We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectus$241.6 million.
Appears in 1 contract
Samples: Merger Agreement (Labarge Inc)
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus, each prospectus supplement and the information incorporated by reference in this prospectus and each prospectus supplement contain “forward- looking statements,” which include information relating to future events, future financial performance, strategies, expectations, competitive environment and regulation. Words such as “may,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, are intended to identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will actually be achieved. Forward-looking statements are based on information we have when those statements are made or our management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to: • Our history of recurring losses and negative cash flows from operating activities and the uncertainty regarding the adequacy of our liquidity to pursue or complete our business objectives. • Our inability to carry out research, development and commercialization plans. • Our inability to manufacture our PURE EP product on a commercial scale on our own or in collaborations with third parties. • Our inability to complete preclinical testing and clinical trials as anticipated. • Our ability to adequately protect and enforce rights to intellectual property. • Difficulties in obtaining financing on commercially reasonable terms, or at all. • Intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do. • Entry of new competitors and products and potential technological obsolescence of our products. • Adverse market and economic conditions. • Our ability to maintain the listing of our common stock on the Nasdaq Capital Market. • Loss of one or more key executives or scientists. • Difficulties in securing and retaining regulatory approval to market our product and product candidates. You should read this prospectus, the applicable prospectus supplement and any related free-writing prospectus and the financial statements and other documents incorporated by reference in this prospectus contain forward-looking statementswith the understanding that our actual future results, including statements concerning our industrylevels of activity, our operations, our anticipated financial performance and financial condition, events and our business plans and growth strategy and product development effortscircumstances may be materially different from what we expect. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Many of the The forward-looking statements contained or incorporated by reference in this prospectus can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: • our operation as a development stage company with a history of operating losses; as of December 31, 2021, our accumulated deficit was €333.4 million; • the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; • our reliance on contract manufacturers and contract research organizations over which we have limited control; • our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; • our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not viable; • uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; • the outcome of any discussions we may enter regarding acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; • the chance that we may become exposed prospectus supplement are expressly qualified in their entirety by this cautionary statement. We do not undertake any obligation to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or after they become commercial products; • if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory oversight; • enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; • future legislation may materially impact our ability to realize revenue from any approved and commercialized products; • the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; • our reliance on our current strategic relationships with LLS, The MD Xxxxxxxx Cancer Center, Genentech, Roivant, Artiva and NKGen Biotech (formerly known as NKMax America), and the potential failure to enter into new strategic relationships; • our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; • our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; • our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; • the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; • the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and • other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, or implied by, publicly update any forward-looking statements relating statement to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the COVID-19 pandemic. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future reflect events or otherwise. We are a clinical-stage immuno-oncology company focused circumstances after the date on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach which any such statement is made or to cancer treatment that seeks to harness reflect the body’s own immune defenses to fight tumor cells. One occurrence of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings. The common shares covered by this prospectus refer to the common shares of Affimed N.V. The offices of Affimed N.V. are located at Technologiepark, Xx Xxxxxxxxxxx Xxxx 000, 69120 Heidelberg, Germany. Our telephone number is (+00) 0000-0000-00. Investors should contact us for any inquiries at the address and telephone number of our principal executive office. Our principal website is xxx.xxxxxxx.xxx. The information contained on our website is not a part of this prospectusunanticipated events.
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