looking Statements. Any statements in this press release about our future expectations, plans and prospects, including statements about: the relationship of the XXX receptor to cancer development; future milestone-based payments, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: our ability to successfully research, develop and obtain and maintain regulatory approvals for our product candidates; the possibility that favorable preclinical may not be predictive of the results in future preclinical and clinical trials; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including with respect to the further development of tivozanib; competition; general economic and industry conditions; and other factors discussed in the “Risk Factors” section of our most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Appears in 2 contracts
Samples: Research and License Agreement (Aveo Pharmaceuticals Inc), Research and License Agreement (Aveo Pharmaceuticals Inc)
looking Statements. Any The contents of this announcement include statements in this press release about our future expectationsthat are, plans and prospectsor may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including statements about: the relationship of the XXX receptor to cancer development; future milestone-based payments, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words terms “believes,” “estimates,” “anticipates,” “plans,” “expects,” “intends,” “may,” “will,” or “should” and similar expressionsinclude statements argenx makes concerning the intended results of its strategy and its collaboration with Xxxxxxx expected to close in the first quarter of 2019, constitute including argenx’s ability to receive the expected benefits thereof such as future milestones and royalty payments.. By their nature, forward-looking statements within the meaning involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of The Private Securities Litigation Reform Act of 1995future performance. Actual argenx’s actual results may differ materially from those indicated predicted by such the forward-looking statements as a result of various important factors, including risks relating to: our ability to successfully researchargenx’s expectations regarding its the inherent uncertainties associated with competitive developments, develop preclinical and obtain clinical trial and maintain product development activities and regulatory approvals for our approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; the possibility that favorable preclinical may not be predictive of the results in future preclinical and clinical trials; our inability argenx’s ability to obtain and maintain adequate protection for of intellectual property rights relating for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to our obtain additional funding for operations and to complete the development and commercialization of its product candidates candidates. A further list and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goalsdescription of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including with respect to the further development of tivozanib; competition; general economic and industry conditions; and other factors discussed in the “Risk Factors” section of our argenx’s most recent annual report on Form 1020-Q F filed with the Securities SEC as well as subsequent filings and Exchange Commission, and in other filings that we periodically make reports filed by argenx with the SEC. In additionGiven these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do sostatements. These forward-looking statements should not be relied upon as representing our views speak only as of any date subsequent to the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Argenx Se), Investment Agreement (Argenx Se)
looking Statements. Any Except for the historical information and discussions contained herein, statements contained in this press release about our future expectations, plans and prospects, including statements about: the relationship of the XXX receptor to cancer development; future milestone-based payments, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words constitute “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute forward-looking statements statements” within the meaning of The the Private Securities Litigation Reform Act of 1995. Actual Our forward-looking statements are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding Safeguard’s initiatives taken or contemplated to enhance and unlock value for all of its shareholders, Safeguard’s efforts to execute on and implement its strategy to streamline its organizational structure, reduce its operating costs, pursue monetization opportunities for Partner Companies and maximize the net proceeds distributable to its shareholders, Safeguard’s ability to create, unlock, enhance and maximize shareholder value, Safeguard’s ability to have a smooth transition to a new management team, the timing of Safeguard’s management succession plan and its effect on driving increased organizational effectiveness and efficiencies, the ability of the new management team to execute Safeguard’s strategy, the availability of, the timing of, and the proceeds that may ultimately be derived from the monetization of Partner Companies, Safeguard’s projections regarding the reduction in its ongoing operating expenses, Safeguard’s projections regarding annualized operating expenses and expected severance expenses, monetization opportunities for Partner Company Interests, and the amount of net proceeds from the monetization of Partner Company Interests that are ultimately distributable to Safeguard shareholders after satisfying Safeguard’s debt obligations and working capital needs and the timing of such distributions. Such forward-looking statements are not guarantees of future operational or financial performance and are based on current expectations that involve a number of uncertainties, risks and assumptions that are difficult to predict. Therefore, actual outcomes and/or results may differ materially from those indicated expressed or implied by such forward-looking statements statements. The risks and uncertainties that could cause actual results to differ materially include, among others, our ability to make good decisions about the monetization of our Partner Companies for maximum value or at all and distributions to our shareholders, our ability to successfully execute on our strategy to streamline our organizational structure and align our cost structure to increase shareholder value, whether our strategy will better position us to focus our resources on the highest-return opportunities and deliver enhanced shareholder value, the ongoing support of our existing Partner Companies, the fact that our Partner Companies may vary from period to period, challenges to achieving liquidity from our partner company holdings, fluctuations in the market prices of our publicly traded partner company holdings, competition, our inability to obtain maximum value for our partner company holdings, our ability to attract and retain qualified employees, market valuations in sectors in which our Partner Companies operate, our inability to control our Partner Companies, our need to manage our assets to avoid registration under the Investment Company Act of 1940, risks, disruption, costs and uncertainty caused by or related to the actions of activist shareholders, including that if individuals are elected to our Board with a specific agenda, it may adversely affect our ability to effectively implement our business strategy and create value for our shareholders and perceived uncertainties as to our future direction as a result of various important factorspotential changes to the composition of our Board may lead to the perception of a change in the direction of our business, instability or a lack of continuity that may adversely affect our business, and risks associated with our Partner Companies, including risks relating to: the fact that most of our ability to successfully researchPartner Companies have a limited operating history and a history of operating losses, develop face intense competition and obtain and maintain regulatory approvals for our product candidates; may never be profitable, the possibility that favorable preclinical may not be predictive effect of economic conditions in the results business sectors in future preclinical and clinical trials; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goalswhich Safeguard’s Partner Companies operate, including with respect to the further development of tivozanib; competition; general economic and industry conditions; and other factors discussed uncertainties described in the “Risk Factors” section of our most recent Form 10-Q filed filings with the Securities and Exchange Commission, . Many of these factors are beyond the Company’s ability to predict or control. As a result of these and in other filings that we periodically make with the SEC. In additionfactors, the Company’s past operational and financial performance should not be relied on as an indication of future performance. The Company does not assume any obligation to update any forward-looking statements included or other information contained in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Appears in 2 contracts
Samples: Cooperation Agreement (Horton Capital Management, LLC), Cooperation Agreement (Safeguard Scientifics Inc)
looking Statements. Any statements in this press release about our Ophthotech's future expectations, plans and prospects, including statements about: the relationship of the XXX receptor to cancer development; future milestone-based payments, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, prospects constitute forward-looking statements within for purposes of the meaning of The safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially Forward- looking statements include any statements about Ophthotech's strategy, future operations and future expectations and plans and prospects for Ophthotech, and any other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. In this press release, Ophthotech's forward looking statements include statements about the anticipated receipt of payments under its licensing and commercialization agreement with Novartis, the conduct of the Fovista Phase 3 clinical program, including obtaining initial, top-line data from those indicated by such the Fovista Phase 3 clinical program and seeking marketing approval for Fovista, the potential of Fovista as a wet AMD combination therapy and the development of new drug-delivery technologies. Such forward-looking statements as a result involve substantial risks and uncertainties that could cause Ophthotech's clinical development programs, future results, performance or achievements to differ significantly from those express or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the initiation and conduct of various important factorsclinical trials, including risks relating to: our Ophthotech's ability to successfully researchsatisfy certain patient enrollment milestones, develop and obtain and maintain availability of data from clinical trials, expectations for regulatory approvals for our product candidates; or other actions, including the possibility that favorable preclinical may not be predictive receipt of regulatory approvals outside of the results in future preclinical United States which would trigger the receipt of certain milestone payments, Ophthotech's ability to comply with its obligations under and clinical trials; our inability to obtain otherwise maintain its licensing and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including commercialization agreement with respect to the further development of tivozanib; competition; general economic and industry conditions; Novartis and other factors discussed in the “"Risk Factors” " section of our most recent Form 10-Q filed with contained in the Securities quarterly and Exchange Commission, and in other filings annual reports that we periodically make Ophthotech files with the SEC. In addition, the Any forward-looking statements included in this press release represent our Ophthotech's views only as of the date of this press release. We anticipate Ophthotech anticipates that subsequent events and developments will cause our its views to change. However, while we While Ophthotech may elect to update these forward-looking statements at some point in the future, we Ophthotech specifically disclaim disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Appears in 2 contracts
Samples: Licensing Agreement, Licensing Agreement
looking Statements. Any This Prospectus Supplement, the Prospectus and the documents incorporated by reference in the Prospectus contain certain statements in this press release about our relating to future expectationsevents or the Corporation’s future performance which constitute forward-looking statements. Such forward-looking statements involve known and unknown risks, plans uncertainties and prospectsother factors which may cause the actual results, including statements about: the relationship performance or achievements of the XXX receptor Corporation, or industry results, to cancer developmentbe materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements are statements that are not historical facts, and include, but are not limited to, estimates and their underlying assumptions; statements regarding plans, objectives and expectations with respect to the efficacy of our technologies; the timing and results of clinical studies related to our technologies; future milestone-based paymentsoperations, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEOproducts and services; the potential impact of regulatory initiatives on our antibody research and development capabilitiesoperations; the potential size of and opportunities related to the markets for our cancer biology platform technologies; general industry and macroeconomic growth rates; expectations related to offer a unique advantage in oncology drug development; the; possible joint and/or strategic ventures and other statements containing regarding future performance. Forward-looking statements generally, but not always, are identified by the words “believesexpects,” “anticipates,” “plansbelieves,” “expectsintends,” “willestimates,” “projects”, “potential”, “possible” and similar expressions, constitute or that events or conditions “will,” “may,” “could” or “should” occur. The forward-looking statements within in this Prospectus Supplement, the meaning Prospectus and the documents incorporated by reference in the Prospectus are subject to various risks and uncertainties, most of which are difficult to predict and generally beyond the Corporation’s control. The Private Securities Litigation Reform Act summary of 1995risk factors below is not exhaustive of the factors that may affect any of the Corporation’s forward-looking statements. Actual results may differ materially from those indicated by such Some of the important risks and uncertainties that could affect forward-looking statements are described further under the heading “Risk Factors” in this Prospectus Supplement, in the Prospectus and in the Corporation’s Annual Report (as defined below). If one or more of these risks or uncertainties materializes, or if underlying assumptions prove incorrect, our actual results may vary materially from those expected, estimated or projected. Forward-looking statements in this document are not a result prediction of various important factorsfuture events or circumstances, and those future events or circumstances may not occur. Given these uncertainties, users of the information included herein, including investors and prospective investors, are cautioned not to place undue reliance on such forward- looking statements. Investors should consult our quarterly and annual filings with the securities commissions or similar regulatory authorities in Canada and the SEC for additional information on risks and uncertainties relating to: to forward-looking statements. · risks related to all of our potential products, including pelareorep, being in the research and development stage and requiring further development and testing before they can be marketed commercially; · risks related to any failure or delay in clinical trials for our products, including pelareorep; · risks arising due to our candidate product, pelareorep, being used in combination with third-party drugs over which we have limited or no control over supply; · risks related to the COVID-19 pandemic; · risks related to the impact of any undesirable side effects or other properties that our product candidate, pelareorep, may have; · the risk that we may expend our limited resources to pursue a particular indication and fail to capitalize on indications that may be more profitable or for which there is a greater likelihood of success; · the risk that we may need additional financing in the future to fund the research and development of our products and to meet our ongoing capital requirements; · risks related to the intense regulatory approval processes under which pharmaceutical products are subject; · the risk that our operations and products may be subject to other government manufacturing and testing regulations; · risks related to our conduct of clinical trials for pelareorep in sites outside the United States; · risks related to our reliance on patents and proprietary rights to protect our technology; · the risk that third parties may choose to file patent infringement claims against us; · the risk related to our ability to successfully research, develop protect the confidentiality of our proprietary information and know-how; · risks related to the sharing of our trade secrets with third parties; · risks related to developments in patent law; · risks related to the requirement to obtain protection under the Xxxxx-Xxxxxx amendments and maintain regulatory approvals similar foreign legislation for extending the term of patents covering each of our product candidates; · the possibility risk that favorable preclinical our products may fail or cause harm, subjecting us to product liability claims; · the risk that new products may not be predictive accepted by the medical community or consumers; · the risk that our technologies may become obsolete; · risks related to our reliance on third-party manufacturers to produce our clinical products and on other third parties to store, monitor and transport bulk drug substance and drug product; · risks related to our reliance on third parties to produce and provide suitable raw materials for pelareorep production, packaging, and testing as well as clinical trial- related testing; · risks related to our reliance on third parties to monitor, support, conduct and oversee clinical trials of the results products that we are developing and, in future preclinical and clinical trialssome cases, to maintain regulatory files for those product candidates; our inability to obtain and maintain adequate protection for intellectual property rights relating · risks related to our product candidates dependence on Xxxxx Nortye Biopharma Co. and technologiesour doing business in foreign jurisdictions in connection with our license, development, supply and distribution agreement with Xxxxx Nortye; unplanned operating expenses· the risk that our employees, independent contractors, principal investigators, contract research organizations, consultants and vendors may engage in misconduct or other improper activities; · risks related to events outside of our inability control, such as natural disasters, wars or health epidemics; · risks related to raise substantial additional funds the cost of director and officer liability insurance; · risks related to achieve our goalsdependence on our key employees and collaborators; · risks related to our likely status as a “passive foreign investment company”; · the potential dilution of present and prospective shareholdings; and · risks related to disruptions to our information technology systems, including with respect to the further development disruptions from cybersecurity breaches of tivozanib; competition; general economic and industry conditionsour information technology infrastructure; and other · risks related to our Common Shares. The Corporation cautions that the foregoing list of factors discussed in the “Risk Factors” section of our most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SECmay affect future results is not exhaustive. In addition, the The forward-looking statements included information contained in this press release represent our views Prospectus Supplement, the Prospectus and the documents incorporated by reference in the Prospectus is made as of the date of this press releasesuch documents. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these The forward-looking statements at some point information contained in this Prospectus Supplement, the Prospectus and in the future, we specifically disclaim documents incorporated by reference in the Prospectus is expressly qualified by this cautionary statement. The Corporation does not undertake any obligation to do so. These publicly update or revise any forward-looking statements should not information except as required pursuant to applicable securities laws. Information has been incorporated by reference in the Prospectus from documents filed with securities commissions or similar authorities in Canada. Copies of the documents incorporated herein by reference may be relied upon as representing obtained on request without charge from our views as Corporate Secretary at Suite 000, 000 – 00xx Xxxxxx X.X., Xxxxxxx, Xxxxxxx X0X 0X0 telephone (000) 000-0000, and are available electronically under the Corporation’s profile on SEDAR (xxx.xxxxx.xxx) and on XXXXX (xxx.xxx.xxx/xxxxx.xxxxx). The following documents, filed with the securities commissions or similar regulatory authorities in each of any date subsequent to the date provinces of this press release.Canada and filed with, or furnished to, the SEC are specifically incorporated by reference into, and form an integral part of, the Prospectus:
Appears in 1 contract
Samples: Equity Distribution Agreement
looking Statements. Any This announcement contains forward-looking statements in this press release about our future expectations, plans and prospects, including statements about: within the relationship meaning of the XXX receptor to cancer development; future milestone“safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-based payments, research funding or royalties which may looking statements can be paid identified by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words such as “believes,” “anticipateswill,” “plans,” “expects,” “willlong-term,” and “priorities,” “pipeline,” “could,” “accelerate,” “potential,” “believe,” “first-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar expressionsterms, constitute or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates, or regarding potential future revenues from any such drug candidates; potential shareholder returns; or regarding any potential financial or other impact on Chi-Med of our acceleration of the savolitinib global development program; or regarding any potential financial or other impact on Chi-Med of the amendment to the co-development agreement with AstraZeneca; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements within are based on the meaning current beliefs and expectations of The Private Securities Litigation Reform Act management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of 1995. Actual these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may differ vary materially from those indicated by set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates will achieve any particular revenue levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or gain commercial acceptance after obtaining regulatory approval; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries and uncertainties regarding future global exchange rates. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of various important factorsnew information, including risks relating to: our ability to successfully research, develop and obtain and maintain regulatory approvals for our product candidates; the possibility that favorable preclinical may not be predictive of the results in future preclinical and clinical trials; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including with respect to the further development of tivozanib; competition; general economic and industry conditions; and other factors discussed in the “Risk Factors” section of our most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press releaseor otherwise.
Appears in 1 contract
Samples: Co Development Agreement (Hutchison China MediTech LTD)
looking Statements. Any statements in this press release about our Ophthotech’s future expectations, plans and prospects, including statements about: the relationship of the XXX receptor to cancer development; future milestone-based payments, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, prospects constitute forward-looking statements within for purposes of the meaning of The safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially Forward-looking statements include any statements about Ophthotech’s strategy, future operations and future expectations and plans and prospects for Ophthotech, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. In this press release, Ophthotech’s forward looking statements include statements about the anticipated receipt of payments under its licensing and commercialization agreement with Novartis, the conduct of the Xxxxxxx Xxxxx 0 clinical program, including obtaining initial, top-line data from those indicated by such the Xxxxxxx Xxxxx 0 clinical program and seeking marketing approval for Fovista, the potential of Fovista as a wet AMD combination therapy and the development of new drug-delivery technologies. Such forward-looking statements as a result involve substantial risks and uncertainties that could cause Ophthotech’s clinical development programs, future results, performance or achievements to differ significantly from those express or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the initiation and conduct of various important factorsclinical trials, including risks relating to: our Ophthotech’s ability to successfully researchsatisfy certain patient enrollment milestones, develop and obtain and maintain availability of data from clinical trials, expectations for regulatory approvals for our product candidates; or other actions, including the possibility that favorable preclinical may not be predictive receipt of regulatory approvals outside of the results in future preclinical United States which would trigger the receipt of certain milestone payments, Ophthotech’s ability to comply with its obligations under and clinical trials; our inability to obtain otherwise maintain its licensing and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including commercialization agreement with respect to the further development of tivozanib; competition; general economic and industry conditions; Novartis and other factors discussed in the “Risk Factors” section of our most recent Form 10-Q filed with contained in the Securities quarterly and Exchange Commission, and in other filings annual reports that we periodically make Ophthotech files with the SEC. In addition, the Any forward-looking statements included in this press release represent our Ophthotech’s views only as of the date of this press release. We anticipate Ophthotech anticipates that subsequent events and developments will cause our its views to change. However, while we While Ophthotech may elect to update these forward-looking statements at some point in the future, we Ophthotech specifically disclaim disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Appears in 1 contract
Samples: Licensing and Commercialization Agreement (Ophthotech Corp.)
looking Statements. Any This Prospectus Supplement, the Prospectus and the documents incorporated by reference in the Prospectus contain certain statements in this press release about our relating to future expectationsevents or the Corporation’s future performance which constitute forward-looking statements. Such forward-looking statements involve known and unknown risks, plans uncertainties and prospectsother factors which may cause the actual results, including statements about: the relationship performance or achievements of the XXX receptor Corporation, or industry results, to cancer developmentbe materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements are statements that are not historical facts, and include, but are not limited to, estimates and their underlying assumptions; statements regarding plans, objectives and expectations with respect to the efficacy of our technologies; the timing and results of clinical studies related to our technologies; future milestone-based paymentsoperations, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEOproducts and services; the potential impact of regulatory initiatives on our antibody research and development capabilitiesoperations; the potential size of and opportunities related to the markets for our cancer biology platform technologies; general industry and macroeconomic growth rates; expectations related to offer a unique advantage in oncology drug development; the; possible joint and/or strategic ventures and other statements containing regarding future performance. Forward-looking statements generally, but not always, are identified by the words “believesexpects,” “anticipates,” “plansbelieves,” “expectsintends,” “willestimates,” “projects”, “potential”, “possible” and similar expressions, constitute or that events or conditions “will,” “may,” “could” or “should” occur. The forward-looking statements within in this Prospectus Supplement, the meaning Prospectus and the documents incorporated by reference in the Prospectus are subject to various risks and uncertainties, most of The Private Securities Litigation Reform which are difficult to predict and generally beyond the Corporation’s control, including without limitation: · risks related to all of our products, including pelareorep, being in the research and development stage and requiring further development and testing before they can be marketed commercially; · risks inherent in pharmaceutical research and development; · risks related to timing and possible delays in our clinical trials; · risks related to some of our clinical trials being conducted in, and subject to the laws of, foreign countries; · risks related to our pharmaceutical products being subject to intense regulatory approval processes in the United States and other foreign jurisdictions; · risks related to being subject to government manufacturing and testing regulations; · risks related to the extremely competitive biotechnology industry and our competition with larger companies with greater resources; · risks related to our reliance on patents and proprietary rights to protect our technology; · risks related to potential product liability claims; · risks related to our limited manufacturing experience and reliance on third parties to commercially manufacture our products, if and when developed; · risks related to our new products not being accepted by the medical community or consumers; · risks related to our technologies becoming obsolete; · risks related to our dependence on third party relationships for research and clinical trials; · risks related to our license, development, supply and distribution agreement with Xxxxx Nortye Biopharma Co. Ltd.; · risks related to our lack of operating revenues and history of losses; · uncertainty regarding our ability to obtain third-party reimbursement for the costs of our product; · risks related to other third-party arrangements; · risks related to our ability to obtain additional financing to fund future research and development of our products and to meet ongoing capital requirements; · risks related to potential increases in the cost of director and officer liability insurance; · risks related to our dependence on key employees and collaborators; · risks related to Barbados law, including those relating to the enforcement of judgments obtained in Canada or the United States; · risks related to the effect of changes in the law on our corporate structure; · risks related to expenses in foreign currencies and our exposure to foreign currency exchange rate fluctuations; · risks related to data privacy laws; · risks related to our information technology systems and security breaches; · risks related to our compliance with the Xxxxxxxx-Xxxxx Act of 19952002, as amended; · risks related to our status as a foreign private issuer; · risks related to possible “passive foreign investment company” status; · risks related to fluctuations in interest rates; · risks related to information technology systems; · risks related to business interruptions resulting from pandemics and public health emergencies, including those related to COVID-19 coronavirus, geopolitical actions, including war and terrorism or natural disasters including earthquakes, typhoons, floods and fires; and · risks related to our Common Shares. Actual This list is not exhaustive of the factors that may affect any of the Corporation’s forward-looking statements. Some of the important risks and uncertainties that could affect forward-looking statements are described further under the heading “Risk Factors” in this Prospectus Supplement, in the Prospectus and in the Corporation’s Annual Report (as defined below). If one or more of these risks or uncertainties materializes, or if underlying assumptions prove incorrect, our actual results may differ vary materially from those indicated by expected, estimated or projected. Forward-looking statements in this document are not a prediction of future events or circumstances, and those future events or circumstances may not occur. Given these uncertainties, users of the information included herein, including investors and prospective investors, are cautioned not to place undue reliance on such forward-looking statements as a result of various important factors, including statements. Investors should consult our quarterly and annual filings with the securities commissions or similar regulatory authorities in Canada and the SEC for additional information on risks relating to: our ability to successfully research, develop and obtain and maintain regulatory approvals for our product candidates; the possibility that favorable preclinical may not be predictive of the results in future preclinical and clinical trials; our inability to obtain and maintain adequate protection for intellectual property rights uncertainties relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including with respect to the further development of tivozanib; competition; general economic and industry conditions; and other factors discussed in the “Risk Factors” section of our most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included statements. The Corporation cautions that the foregoing list of factors that may affect future results is not exhaustive. The forward-looking information contained in this press release represent our views Prospectus Supplement, the Prospectus and the documents incorporated by reference in the Prospectus is made as of the date of this press releasesuch documents. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these The forward-looking statements at some point information contained in this Prospectus Supplement, the Prospectus and in the future, we specifically disclaim documents incorporated by reference in the Prospectus is expressly qualified by this cautionary statement. The Corporation does not undertake any obligation to do so. These publicly update or revise any forward-looking information except as required pursuant to applicable securities laws. Information has been incorporated by reference in the Prospectus from documents filed with securities commissions or similar authorities in Canada.Copies of the documents incorporated herein by reference may be obtained on request without charge from our Corporate Secretary at 000, 0000 Xxxxxxxxxx Xxxxxxxx X.X., Xxxxxxx, Xxxxxxx, X0X 0X0 telephone (000) 000-0000, and are available electronically under the Corporation’s profile on SEDAR ( xxx.xxxxx.xxx) and on XXXXX (xxx.xxx.xxx/xxxxx.xxxxx). The following documents, filed with the securities commissions or similar regulatory authorities in each of the provinces of Canada and filed with, or furnished to, the SEC are specifically incorporated by reference into, and form an integral part of, the Prospectus: · our annual report on Form 20-F ("Annual Report") dated March 6, 2020, for the year ended December 31, 2019 (filed in Canada with certain Canadian securities regulatory authorities as our annual information form for the year ended December 31, 2019); · our management information circular dated March 16, 2020 relating to the annual general meeting of shareholders held on May 7, 2020; · our audited consolidated financial statements, together with the notes thereto, as at December 31, 2019 and 2018, which comprise the consolidated statements should not of financial position as at December 31, 2019 and 2018, and the consolidated statements of loss and comprehensive loss, changes in equity, and cash flows for the years ended December 31, 2019, 2018 and 2017, together with the independent auditors' report thereon; and · our management's discussion and analysis of financial condition and results of operations dated March 5, 2020, for the year ended December 31, 2019; · our unaudited interim consolidated financial statements, together with the notes thereto, as at September 30, 2020, which comprise the interim consolidated statements of financial position as at September 30, 2020 and December 31, 2019, and the interim consolidated statements of loss and comprehensive loss, changes in equity, and cash flows for the three and nine months ended September 30, 2020 and 2019; and · our management's discussion and analysis of financial condition and results of operations dated November 3, 2020, for the nine months ended September 30, 2020. Any documents of the type required by National Instrument 44-101 -Short Form Prospectus Distributions to be relied upon as representing our views as incorporated by reference in a short form Prospectus, including any annual information form, annual report on Form 20-F, comparative annual consolidated financial statements and the auditors’ report thereon, comparative interim consolidated financial statements, management’s discussion and analysis of any date subsequent to financial condition and results of operations, material change report (except a confidential material change report), business acquisition report and information circular, if filed by us with the securities commissions or similar authorities in Canada after the date of this press releaseProspectus Supplement and prior to the date on which the Offering under this Prospectus Supplement ends, shall be deemed to be incorporated by reference in the Prospectus. In addition, to the extent that any document or information incorporated by reference in the Prospectus is included in any report filed with or furnished to the SEC pursuant to the United States Securities Exchange Act of 1934, as amended (the “U.S. Exchange Act”), after the date of this Prospectus Supplement and prior to the date on which the Offering under this Prospectus Supplement ends, such document or information shall be deemed to be incorporated by reference as an exhibit to the registration statement of which this Prospectus Supplement and the Prospectus forms a part (in the case of documents or information deemed furnished on Form 6-K or Form 8-K, only to the extent specifically stated therein).
Appears in 1 contract
Samples: Equity Distribution Agreement
looking Statements. Any statements in this press release about our Ophthotech’s future expectations, plans and prospects, including statements about: the relationship of the XXX receptor to cancer development; future milestone-based payments, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, prospects constitute forward-looking statements within for purposes of the meaning of The safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially Forward-looking statements include any statements about Ophthotech’s strategy, future operations and future expectations and plans and prospects for Ophthotech, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. In this press release, Ophthotech’s forward looking statements include statements about the anticipated receipt of payments under its licensing and commercialization agreement with Novartis, the conduct of the Fovista Phase 3 clinical program, including obtaining initial, top-line data from those indicated by such the Fovista Phase 3 clinical program and seeking marketing approval for Fovista, the potential of Fovista as a wet AMD combination therapy and the development of new drug-delivery technologies. Such forward-looking statements as a result involve substantial risks and uncertainties that could cause Ophthotech’s clinical development programs, future results, performance or achievements to differ significantly from those express or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the initiation and conduct of various important factorsclinical trials, including risks relating to: our Ophthotech’s ability to successfully researchsatisfy certain patient enrollment milestones, develop and obtain and maintain availability of data from clinical trials, expectations for regulatory approvals for our product candidates; or other actions, including the possibility that favorable preclinical may not be predictive receipt of regulatory approvals outside of the results in future preclinical United States which would trigger the receipt of certain milestone payments, Ophthotech’s ability to comply with its obligations under and clinical trials; our inability to obtain otherwise maintain its licensing and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including commercialization agreement with respect to the further development of tivozanib; competition; general economic and industry conditions; Novartis and other factors discussed in the “Risk Factors” section of our most recent Form 10-Q filed with contained in the Securities quarterly and Exchange Commission, and in other filings annual reports that we periodically make Ophthotech files with the SEC. In addition, the Any forward-looking statements included in this press release represent our Xxxxxxxxxx’s views only as of the date of this press release. We anticipate Ophthotech anticipates that subsequent events and developments will cause our its views to change. However, while we While Ophthotech may elect to update these forward-forward- looking statements at some point in the future, we Ophthotech specifically disclaim disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Appears in 1 contract
Samples: Licensing Agreement
looking Statements. Any statements in this This press release about our future expectations, plans and prospects, including statements about: the relationship of the XXX receptor to cancer development; future milestone-based payments, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words contains “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute forward-looking statements within statements” that involve substantial risks and uncertainties for purposes of the meaning of The safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the structure, terms, timing and entry into a definitive agreement for the proposed collaboration between Acer and Relief with respect to ACER-001; the shared values, vision and results of the potential collaboration of Acer and Relief; the potential for ACER-001 to target diseases; the adequacy of Acer’s capital to support its future operations and its ability to successfully continue its development programs; Acer’s ability to secure the additional capital necessary to fund its various product candidate development programs; and the development and commercial potential of any of Acer’s product candidates including ACER-001. Acer may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results may and performance could differ materially from those indicated by such projected in the forward-looking statements as a result of various important many factors, including including, without limitation, risks relating to: our and uncertainties associated with Acer’s ability to successfully researchnegotiate and execute a definitive collaboration agreement with Relief on the proposed terms, develop on other mutually acceptable terms, or at all, Acer’s ability to repay the $4 million secured loan from Relief, the ability to project future cash utilization and obtain reserves needed for contingent future liabilities and maintain regulatory approvals for our business operations, the availability of sufficient resources to fund Acer’s various product candidates; candidate development programs and to meet its business objectives and operational requirements, the possibility fact that favorable preclinical the results of earlier studies and trials may not be predictive of future clinical trial results, the results in future preclinical protection and clinical trials; our inability to obtain and maintain adequate protection for market exclusivity provided by Acer’s intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goalsproperty, including with respect risks related to the further development drug discovery and the regulatory approval process and the impact of tivozanib; competition; general economic competitive products and industry conditions; and other factors discussed technological changes. Acer disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures Acer makes in the “Risk Factors” section of our most recent Form 10-Q filed its filings with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q and in other filings that we periodically make with the SEC. In addition, the forwardits Annual Report on Form 10-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we K. You may elect to update access these forward-looking statements documents for no charge at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press releasexxxx://xxx.xxx.xxx.
Appears in 1 contract
Samples: Option Agreement
looking Statements. Any statements The information in this press news release about our future expectations, plans and prospects, including statements about: the relationship of the XXX receptor to cancer development; future milestone-based payments, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute contains forward-looking statements and information within the meaning of The Private Section 27A of the Securities Litigation Reform Act of 19951933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. Actual This news release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to: Dermira’s goal of bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions; the opportunity to deliver a product having a combination of safety, tolerability, efficacy, convenience and ease of use to people living with moderate-to-severe atopic dermatitis and the healthcare practitioners who care for them; the hope that lebrikizumab will advance the standard of care for the millions of people living with atopic dermatitis; the belief that lebrikizumab could become a best-in-disease therapy for the treatment of moderate-to-severe atopic dermatitis; the successful completion of, and timing expectations for the receipt and announcement of topline data from, the Phase 2b study of lebrikizumab for the treatment of moderate-to-severe atopic dermatitis; the potential exercise of the option by Xxxxxxxx and the anticipated fees, payments and royalties associated therewith; future registrational studies of lebrikizumab in patients with moderate-to-severe atopic dermatitis; potential regulatory approval and the future availability of lebrikizumab for the treatment of moderate-to-severe atopic dermatitis; and the anticipated creation of a growth platform for Dermira and Almirall. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the design, implementation and outcomes of current and future clinical trials; dependence on third-party clinical research organizations, manufacturers, suppliers and distributors; the outcomes of future meetings with regulatory agencies; Xxxxxxx’s ability to develop and maintain collaborations and license products and intellectual property; Xxxxxxx’s ability to attract and retain key employees; Xxxxxxx’s ability to obtain necessary additional capital; market acceptance of Dermira’s potential products; the impact of competitive products and therapies; Xxxxxxx’s ability to manage the growth and complexity of its organization; Dermira’s ability to maintain, protect and enhance its intellectual property; and Xxxxxxx’s ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Reports on Form 10-Q and other filings Dermira makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those indicated expressed or implied by Xxxxxxx’s forward-looking statements. Furthermore, such forward-looking statements as a result of various important factors, including risks relating to: our ability to successfully research, develop and obtain and maintain regulatory approvals for our product candidates; the possibility that favorable preclinical may not be predictive of the results in future preclinical and clinical trials; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including with respect to the further development of tivozanib; competition; general economic and industry conditions; and other factors discussed in the “Risk Factors” section of our most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views speak only as of the date of this press news release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any Dermira undertakes no obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.publicly update any
Appears in 1 contract
looking Statements. Any statements The information in this press release about our future expectations, plans and prospects, including statements about: the relationship of the XXX receptor to cancer development; future milestone-based payments, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute contains forward-looking statements and information within the meaning of The Private Section 27A of the Securities Litigation Reform Act of 19951933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the "safe harbor" created by those sections. Actual This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to Maruho’s plans for the development and commercialization of, including the initiation of a Phase 1 clinical trial for, DRM04 in Japan; potential payments to Dermira based upon the successful achievement of regulatory- and sales-based milestones for DRM04 and potential royalty payments for net product sales in Japan; the use of DRM04 as a safe and effective treatment for hyperhidrosis; the expected timing for completion of the treatment period for the open-label ARIDO Phase 3 trial and the results of such trial; the timing of the anticipated pre-NDA meeting with the FDA and other registration-enabling activities; and the potential NDA submission to the FDA for DRM04 and the expected timing of such submission. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the design, implementation and outcomes of Dermira’s clinical trials; Dermira’s anticipated pre-NDA meeting with the FDA for DRM04; Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; Dermira’s ability to obtain regulatory approval for its product candidates; Dermira’s ability to continue to stay in compliance with applicable laws and regulations; Maruho’s plans for the development and commercialization of DRM04; and the outcome of Maruho’s discussions with Japanese regulatory authorities for Maruho’s Phase 1 clinical trial of DRM04 in Japan. You should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Reports on Form 10-Q and other filings Dermira makes with the Securities and Exchange Commission from time to time for a discussion of important factors that may cause our actual results to differ materially from those indicated expressed or implied by our forward-looking statements. Furthermore, such forward-looking statements as a result of various important factors, including risks relating to: our ability to successfully research, develop and obtain and maintain regulatory approvals for our product candidates; the possibility that favorable preclinical may not be predictive of the results in future preclinical and clinical trials; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including with respect to the further development of tivozanib; competition; general economic and industry conditions; and other factors discussed in the “Risk Factors” section of our most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views speak only as of the date of this press release. We anticipate that subsequent events and developments will cause our views Dermira undertakes no obligation to change. However, while we may elect to publicly update these any forward-looking statements at some point in the futureor reasons why actual results might differ, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon whether as representing our views a result of new information, future events or otherwise, except as of any date subsequent to the date of this press releaserequired by law.
Appears in 1 contract
looking Statements. Any statements in this This press release about our future expectations, plans and prospects, including statements about: the relationship of the XXX receptor to cancer development; future milestone-based payments, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words contains “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute forward-looking statements within statements” that involve substantial risks and uncertainties for purposes of the meaning of The safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the benefits and results of the Collaboration and License Agreement between Acer and Relief with respect to ACER-001; the potential for ACER-001 to target diseases; the adequacy of Acer’s capital to support its future operations and its ability to successfully continue its development programs; Acer’s ability to secure the additional capital necessary to fund its various product candidate development programs; and the development and commercial potential of any of Acer’s product candidates including ACER-001. Acer may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results may and performance could differ materially from those indicated by such projected in the forward-looking statements as a result of various important many factors, including including, without limitation, risks relating to: our and uncertainties associated with Acer’s ability to successfully researchbenefit from and achieve the results contemplated by the Collaboration and License Agreement with Relief, develop the ability to project future cash utilization and obtain reserves needed for contingent future liabilities and maintain regulatory approvals for our business operations, the availability of sufficient resources to fund Acer’s various product candidates; candidate development programs and to meet its business objectives and operational requirements, the possibility fact that favorable preclinical the results of earlier studies and trials may not be predictive of future clinical trial results, the results in future preclinical protection and clinical trials; our inability to obtain and maintain adequate protection for market exclusivity provided by Acer’s intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goalsproperty, including with respect risks related to the further development drug discovery and the regulatory approval process and the impact of tivozanib; competition; general economic competitive products and industry conditions; and other factors discussed technological changes. Acer disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures Acer makes in the “Risk Factors” section of our most recent Form 10-Q filed its filings with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q and in other filings that we periodically make with the SEC. In addition, the forwardits Annual Report on Form 10-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we K. You may elect to update access these forward-looking statements documents for no charge at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press releasexxxx://xxx.xxx.xxx.
Appears in 1 contract
Samples: Collaboration and License Agreement
looking Statements. Any statements in this press release about our future expectations, plans and prospectsthat are not historical facts, including statements about: regarding the relationship structure, timing and completion of the XXX receptor proposed transaction; Tokai’s continued listing on NASDAQ prior to cancer developmentand after the proposed transaction; future milestone-based paymentsexpectations regarding the capitalization, research funding cash balances and working capital, resources and ownership structure of the company after the transaction; expectations regarding the sufficiency of the company’s resources to fund the advancement of any development program or royalties which may be paid by Centocor Ortho Biotech to AVEOthe completion of any clinical trial; the nature, strategy and focus of the company after the transaction; the safety, efficacy and projected development timeline and commercial potential of our antibody research and development capabilitiesany product candidates; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; expectations regarding voting by Tokai stockholders: and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “willmay,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including including: risks relating to: our and uncertainties associated with stockholder approval of and the ability to successfully research, develop consummate the proposed transaction; whether the anticipated cash resources will be sufficient to fund operations for the period anticipated and obtain to conduct the anticipated studies; whether the necessary approvals to commence clinical trials of Otic’s product candidates can be obtained on a timely basis or at all; and maintain regulatory approvals for our product candidates; the possibility that favorable preclinical may not be predictive of whether the results in future preclinical of clinical trials will warrant submission for regulatory approval, any such submission will receive approval from the United States Food and clinical trials; our inability to obtain and maintain adequate protection for intellectual property rights relating to our Drug Administration or equivalent foreign regulatory agencies and, if any of such product candidates obtains such approval, it will be successfully distributed and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including with respect to the further development of tivozanib; competition; general economic marketed. Risks and industry conditions; and other factors uncertainties facing Tokai are discussed in the “Risk Factors” section of our most recent its quarterly report on Form 10-Q filed with for the Securities and Exchange Commissionthree months ended September 30, and in other filings that we periodically make with the SEC. In addition, the forward-2016 Any forward- looking statements included contained in this press release represent our views speak only as of the date hereof and not of this press release. We anticipate that subsequent events any future date, and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically companies expressly disclaim any obligation to do so. These update any forward-looking statements should not be relied upon statements, whether as representing our views as a result of any date subsequent to the date of this press releasenew information, future events or otherwise.
Appears in 1 contract
Samples: Share Purchase Agreement
looking Statements. This prospectus, any prospectus supplement and the documents incorporated by reference herein or therein contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any statements contained in this press release about our future expectations, plans and prospects, including prospectus or any prospectus supplement or incorporated by reference herein or therein that are not statements about: the relationship of the XXX receptor to cancer development; future milestone-based payments, research funding or royalties which historical fact may be paid by Centocor Ortho Biotech deemed to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing be forward-looking statements. For example, the words “believes,” “anticipates,” “plans,” “expects,” “willintends” and similar expressions, constitute expressions are intended to identify forward-looking statements. Forward-looking statements within involve numerous risks and uncertainties and depend on assumptions, data or methods that may be incorrect or imprecise. Our actual results and the meaning timing of The Private Securities Litigation Reform Act of 1995. Actual results certain events may differ materially significantly from those indicated by such the results discussed in the forward-looking statements as statements. Factors that might cause such a result of various important factorsdiscrepancy include, including risks relating but are not limited to: our ability to successfully research, develop and obtain and maintain regulatory approvals for our product candidates; the possibility that favorable preclinical may not be predictive of the results in future preclinical and clinical trials; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including with respect to the further development of tivozanib; competition; general economic and industry conditions; and other factors those discussed in the “Risk Factors” section of our most recent Form 10this prospectus and under the heading “Risk Factors” in the documents incorporated by reference herein. We claim the protection of the safe harbor for forward-Q filed with looking statements contained in the Private Securities Litigation Reform Act of 1995 for all forward-looking statements. We file annual, quarterly and Exchange Commissioncurrent reports, proxy statements and in other filings that we periodically make information with the SEC. In additionThe SEC maintains a website that contains periodic and current reports, proxy and information statements and other information about issuers, such as us, who file electronically with the forward-looking statements included in this press release represent SEC. The address of that website is xxx.xxx.xxx. Other information about us is also on our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to changewebsite at xxx.xxxxxxx.xxx. However, while we may elect to update these forward-looking statements at some point in except for the futureinformation specifically incorporated by reference herein as set forth below, we specifically disclaim any obligation to the information on or accessible through the SEC’s website and the information on or accessible through our website do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date constitute a part of this press releaseprospectus.
Appears in 1 contract
Samples: Equity Distribution Agreement
looking Statements. Any This Prospectus and the documents incorporated by reference herein contain certain statements in this press release about our relating to future expectations, plans and prospects, including statements about: events or the relationship of the XXX receptor to cancer development; Corporation’s future milestone-based payments, research funding or royalties performance which may be paid by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute forward-looking statements within the meaning of The applicable Canadian securities laws and within the meaning of the United States Private Securities Litigation Reform Act of 1995. Actual Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Corporation, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward- looking statements. Forward-looking statements are statements that are not historical facts, and include, but are not limited to, estimates and their underlying assumptions; statements regarding plans, objectives and expectations with respect to the efficacy of our technologies; the timing and results of clinical studies related to our technologies; future operations, products and services; the impact of regulatory initiatives on our operations; the size of and opportunities related to the markets for our technologies; general industry and macroeconomic growth rates; expectations related to possible joint and/or strategic ventures and statements regarding future performance. Forward-looking statements generally, but not always, are identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “projects”, “potential”, “possible” and similar expressions, or that events or conditions “will,” “may,” “could” or “should” occur. The forward-looking statements in this Prospectus are subject to various risks and uncertainties, most of which are difficult to predict and generally beyond our control, including without limitation: · risks related to all of our potential products, including pelareorep, being in the research and development stage and requiring further development and testing before they can be marketed commercially; · risks related to any failure or delay in clinical trials for our products, including pelareorep; · risks arising due to our candidate product, pelareorep, being used in combination with third-party drugs over which we have limited or no control over supply; · risks related to the COVID-19 pandemic; · risks related to the impact of any undesirable side effects or other properties that our product candidate, pelareorep, may have; · the risk that we may expend our limited resources to pursue a particular indication and fail to capitalize on indications that may be more profitable or for which there is a greater likelihood of success; · the risk that we may need additional financing in the future to fund the research and development of our products and to meet our ongoing capital requirements; · risks related to the intense regulatory approval processes under which pharmaceutical products are subject; · the risk that our operations and products may be subject to other government manufacturing and testing regulations; · risks related to our conduct of clinical trials for pelareorep in sites outside the United States; · risks related to our reliance on patents and proprietary rights to protect our technology; · the risk that third parties may choose to file patent infringement claims against us; · the risk related to our ability to protect the confidentiality of our proprietary information and know-how; · risks related to the sharing of our trade secrets with third parties; · risks related to developments in patent law; · risks related to the requirement to obtain protection under the Xxxxx-Xxxxxx amendments and similar foreign legislation for extending the term of patents covering each of our product candidates; · the risk that our products may fail or cause harm, subjecting us to product liability claims; · the risk that new products may not be accepted by the medical community or consumers; · the risk that our technologies may become obsolete; · risks related to our reliance on third-party manufacturers to produce our clinical products and on other third parties to store, monitor and transport bulk drug substance and drug product; · risks related to our reliance on third parties to produce and provide suitable raw materials for pelareorep production, packaging, and testing as well as clinical trial- related testing; · risks related to our reliance on third parties to monitor, support, conduct and oversee clinical trials of the products that we are developing and, in some cases, to maintain regulatory files for those product candidates; · risks related to our dependence on Xxxxx Nortye Biopharma Co. and our doing business in foreign jurisdictions in connection with our license, development, supply and distribution agreement with Xxxxx Nortye; · the risk that our employees, independent contractors, principal investigators, contract research organizations, consultants and vendors may engage in misconduct or other improper activities; · risks related to events outside of our control, such as natural disasters, wars or health epidemics; · risks related to the cost of director and officer liability insurance; · risks related to our dependence on our key employees and collaborators; · risks related to our likely status as a "passive foreign investment company"; · the potential dilution of present and prospective shareholdings; and · risks related to disruptions to our information technology systems, including disruptions from cybersecurity breaches of our information technology infrastructure; and · risks related to our Securities. This list is not exhaustive of the factors that may affect any of the Corporation’s forward-looking statements. Some of the important risks and uncertainties that could affect forward-looking statements are described further under the heading “Risk Factors” in our Annual Report. If one or more of these risks or uncertainties materializes, or if underlying assumptions prove incorrect, our actual results may differ vary materially from those indicated by expected, estimated or projected. Forward-looking statements in this document are not a prediction of future events or circumstances, and those future events or circumstances may not occur. Given these uncertainties, users of the information included herein, including investors and prospective investors, are cautioned not to place undue reliance on such forward-looking statements as a result of various important factors, including statements. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks relating to: our ability to successfully research, develop and obtain and maintain regulatory approvals for our product candidates; the possibility that favorable preclinical may not be predictive of the results in future preclinical and clinical trials; our inability to obtain and maintain adequate protection for intellectual property rights uncertainties relating to our product candidates and technologies; unplanned operating expenses; our inability forward-looking statements. The Corporation does not undertake any obligation to raise substantial additional funds to achieve our goals, including with respect to publicly update or revise any forward-looking statements other than as required under applicable securities laws. Prospective investors should carefully consider the further development of tivozanib; competition; general economic and industry conditions; and other factors discussed in information contained under the heading “Risk Factors” section of in our most recent Form 10-Q filed with the Securities Annual Report and Exchange Commission, and in all other filings that we periodically make with the SEC. In addition, the forward-looking statements information included in or incorporated by reference in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent Prospectus before making investment decisions with regard to the date of this press releaseSecurities.
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Samples: Equity Distribution Agreement
looking Statements. Any statements in this press release about our future expectations, plans and prospectsThis prospectus, including statements about: the relationship of the XXX receptor to cancer development; future milestone-based paymentsdocuments incorporated by reference herein, research funding or royalties which may be paid by Centocor Ortho Biotech to AVEO; the potential of our antibody research and development capabilities; the potential of our cancer biology platform to offer a unique advantage in oncology drug development; the; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute contains forward-looking statements within the meaning of The the United States Private Securities Litigation Reform Act of 19951995 and “forward-looking information” within the meaning of applicable Canadian securities law. Actual 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 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 various stages of our 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 “anticipate”, “contemplate”, “continue”, “believe”, “plan”, “estimate”, “expect”, “intend”, “will”, “should”, “may”, and other similar expressions. The forward-looking statements contained in this prospectus 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 materially different from any future results, performance, or achievements that may differ materially from those indicated be expressed or implied by such forward-looking statements as statements, including, among others: • our lack of product revenues and net losses and a result history of various important factorsoperating losses; • our early stage of development, including particularly the inherent risks relating to: our ability to successfully research, develop and obtain and maintain regulatory approvals for our product candidates; the possibility that favorable preclinical may not be predictive of the results in future preclinical and clinical trials; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product uncertainties associated with (i) developing new drug candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including with respect to the further development of tivozanib; competition; general economic and industry conditions; and other factors discussed in the “Risk Factors” section of our most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.generally,
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Samples: Common Shares Purchase Agreement