Common use of SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS Clause in Contracts

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectuses and the information incorporated herein and therein by reference contain forward-looking statements within the meaning of the federal securities laws, which statements involve substantial risks and uncertainties. All statements, other than statements of historical facts, included or incorporated by reference in this prospectus supplement and the accompanying prospectuses regarding our strategy, future events, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about: : ● our lack of operating history and history of operating losses; ● our anticipated timing for clinical development, regulatory submissions, commencement and completion of clinical trials and product approvals; ● the results of our clinical trials, including the possibility of unfavorable clinical trial results or that results from our clinical trials will differ from results in past clinical trials; ● actual or anticipated variations in our operating results; ● our cash position; ● market conditions in our industry; ● our ability to complete required clinical trials of our product candidates and obtain approval from the FDA or other regulatory agencies in different jurisdictions; ● the potential impact of the COVID-19 pandemic, including sustained social distancing efforts, on our operations, including our clinical development plans and timelines; ● our ability to maintain or protect the validity of our patents and other intellectual property; ● our ability to retain key personnel; ● our ability to internally develop new inventions and intellectual property; ● interpretations of current laws and the passages of future laws; ● acceptance of our business model by investors; ● the accuracy of our estimates regarding expenses and capital requirements; ● our ability to adequately support growth; ● our expectations related to the use of proceeds from this offering and prior offerings and other financing activities; and ● our estimates regarding expenses, future revenue, capital requirements and ability to satisfy our capital needs. Forward-looking statements may also concern our expectations relating to our subsidiaries. We caution you that the foregoing list may not contain all of the forward-looking statements made in this prospectus supplement and the accompanying prospectuses or the information incorporated herein and therein. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus supplement, the accompanying prospectuses and the information incorporated herein and therein, particularly in “Risk Factors,” that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. You should read this prospectus supplement, the accompanying prospectuses, the documents that we incorporate by reference into this prospectus supplement and the accompanying prospectuses, including our Annual Report on Form 10-K for the year ended December 31, 2019, and the documents that we have filed as exhibits to our filings with the SEC completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectuses prospectus and the information incorporated herein financial statements and therein by reference contain forward-looking statements within the meaning of the federal securities laws, which statements involve substantial risks and uncertainties. All statements, other than statements of historical facts, included or documents incorporated by reference in this prospectus supplement and the accompanying prospectuses regarding our strategy, future events, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would” and similar expressions are intended to identify forward-looking statements, although not all may contain forward-looking statements contain these identifying words. These forward-looking statements includethat are based on our current expectations, among other thingsassumptions, statements about: : ● our lack of operating history estimates and history of operating losses; ● our anticipated timing for clinical development, regulatory submissions, commencement projections about us and completion of clinical trials and product approvals; ● the results of our clinical trials, including the possibility of unfavorable clinical trial results or that results from our clinical trials will differ from results in past clinical trials; ● actual or anticipated variations in our operating results; ● our cash position; ● market conditions in our industry; ● our ability to complete required clinical trials . All statements other than statements of our product candidates and obtain approval from the FDA or other regulatory agencies in different jurisdictions; ● the potential impact of the COVID-19 pandemic, including sustained social distancing efforts, on our operations, including our clinical development plans and timelines; ● our ability to maintain or protect the validity of our patents and other intellectual property; ● our ability to retain key personnel; ● our ability to internally develop new inventions and intellectual property; ● interpretations of current laws and the passages of future laws; ● acceptance of our business model by investors; ● the accuracy of our estimates regarding expenses and capital requirements; ● our ability to adequately support growth; ● our expectations related to the use of proceeds from this offering and prior offerings and other financing activities; and ● our estimates regarding expenses, future revenue, capital requirements and ability to satisfy our capital needs. Forward-looking statements may also concern our expectations relating to our subsidiaries. We caution you that the foregoing list may not contain all of the forward-looking statements made in this prospectus supplement and the accompanying prospectuses or the information incorporated herein and therein. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included historical fact in this prospectus supplement, the accompanying prospectuses prospectus and the information incorporated herein financial statements and therein, particularly in “Risk Factors,” that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. You should read this prospectus supplement, the accompanying prospectuses, the other documents that we incorporate by reference into in this prospectus supplement are forward-looking statements. These forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause our actual results of operations, financial condition, liquidity, performance, prospects, opportunities, achievements or industry results, as well as those of the markets we serve or intend to serve, to differ materially from those expressed in, or suggested by, these forward-looking statements. These forward-looking statements are based on assumptions regarding our present and future business strategies and the accompanying prospectusesenvironment in which we expect to operate in the future. Important factors that could cause those differences include, but are not limited to: • our ability to successfully advance our afami-cel (SPEARHEAD-1) and ADP-A2M4CD8 (MAGE- A4CD8) product candidates through clinical development and the timing within which we can recruit patients, launch trials and treat patients in all of our clinical trials; • our ability to fund our operations; • our ability to successfully and reproducibly manufacture cell therapies in order to meet patient demand; • our ability to implement our strategy and continue with business operations as a result of the outbreak of coronavirus SARS-CoV-2 and the associated disease, or COVID-19; • our ability to further develop our commercial manufacturing process for our cell therapies, transfer such commercial process to third party contract manufacturers, if required, and for such third party contract manufacturers or ourselves to manufacture cell therapies to the quality and on the timescales we require; • our ability to successfully advance our cell therapies technology platform to improve the safety and effectiveness of our existing cell therapies product candidates, to identify and develop new cell therapies and to submit Investigational New Drug Applications, or INDs, for new cell therapies; • the rate and degree of market acceptance of cell therapy generally and of our particular cell therapies; • government regulation and approval; • our ability to successfully commercialize any products and our ability to increase manufacturing capacity, set up processes and recruit employees required for such commercialization; • the existence of any third party patents preventing further development of any of our cell therapies, including, any inability to obtain appropriate third party licenses, or enforcement of patents against us or our collaborators; • our ability to obtain granted patents covering our cell therapies and to enforce such patents against third parties; • volatility in equity markets in general and in the biopharmaceutical sector in particular; • fluctuations in the price of materials and bought-in components; • the scope and timing of performance of our ongoing collaborations with GSK, Genentech and with Universal Cells, a wholly-owned subsidiary of Astellas; • our relationships with suppliers, contract manufacturing organizations or contract research organizations and other third-party providers; • increased competition from other companies in the biotechnology and pharmaceutical industries including where such competition impacts our ability to recruit patients into clinical trials; • claims for personal injury or death arising from the use of our cell therapies; • our ability to attract and retain qualified personnel; and • additional factors that are not known to us at this time. Additional factors that could cause actual results, financial condition, liquidity, performance, prospects, opportunities, achievements or industry results to differ materially include, but are not limited to, those discussed under “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 20192021 filed with the SEC on March 14, 2022 (the “ 2021 Form 10-K”), which is incorporated by reference herein, as updated by our other SEC filings filed after such annual report. Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this prospectus supplement, the accompanying prospectus and the documents that we have filed as exhibits incorporated by reference not to our filings with the SEC completely occur. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation similar words are intended to update any identify estimates and forward-looking statements. Estimates and forward-looking statements speak only as of the date they were made, whether as a result and we undertake no obligation to update or to review any estimate and/or forward-looking statement because of new information, future events or otherwiseother factors. Estimates and forward-looking statements involve risks and uncertainties and are not guarantees of future performance. Our future results may differ materially from those expressed in these estimates and forward-looking statements. In light of the risks and uncertainties described above, except as required the estimates and forward-looking statements discussed in this prospectus supplement, the accompanying prospectus and the documents that we incorporate by lawreference in this prospectus supplement and the accompanying prospectus might not occur, and our future results and our performance may differ materially from those expressed in such forward-looking statements due to, inclusive of, but not limited to, the factors mentioned above. Because of these uncertainties, you should not make any investment decision based on these estimates and forward-looking statements.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectuses and the information incorporated herein and therein by reference contain supplement contains forward-looking statements within the meaning of the federal securities laws, which statements that involve substantial risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements, statements other than statements of historical facts, included or incorporated by reference facts contained in this prospectus supplement and the accompanying prospectuses regarding our strategy, future events, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. The In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions are intended to identify forward-looking statementsor the negative of these words, although not all forward-looking statements contain these identifying wordsor other comparable terminology. These forward-looking statements include, among other thingsbut are not limited to, statements about: : ● • our lack of operating history estimates and history of operating losses; ● expectations regarding our anticipated timing for clinical developmentcapital requirements, regulatory submissionscash and expense levels, commencement and completion of clinical trials and product approvals; ● the results of our clinical trialsliquidity sources, including the possibility of unfavorable clinical trial results or that results from our clinical trials will differ from results in past clinical trials; ● actual or anticipated variations in our operating results; ● our cash position; ● market conditions in our industry; ● our ability to complete required clinical trials continue as a going concern and our need for additional financing; • our strategic transformation activities and expected benefits and costs savings; • the timing for future milestones; • the development and potential benefits of our DDS and OBDS platforms and our other precision medicine platforms; • the development pipeline of therapeutic candidates that use the DDS and OBDS platforms; • the timing and likelihood of regulatory approvals for our product candidates and obtain approval from candidates; • the FDA or other regulatory agencies in different jurisdictionsanticipated indications for our product candidates, if approved; ● • the potential market opportunities for commercializing our products and product candidates; • our expectations regarding the potential market size and the size of the patient populations for our products and product candidates, if approved for commercial use; • the impact of the COVID-19 pandemic, including sustained social distancing efforts, pandemic and related health measures on our operationsbusiness, including financial condition and liquidity; • our ability to develop, acquire, and advance product candidates into, and successfully complete, clinical studies; • the initiation, timing, progress, and results of ongoing and future preclinical and clinical studies, and our research and development plans programs; • the scope of protection we are able to establish and timelinesmaintain for intellectual property rights covering our products and product candidates; ● • our ability to maintain and establish collaborations or protect the validity of our patents and other intellectual propertystrategic relationships or obtain additional funding; ● • our ability to retain key personnelmaintain and establish relationships with third parties, such as contract research organizations, contract manufacturing organizations, suppliers, and distributors; ● • our ability to internally develop new inventions and intellectual property; ● interpretations of current laws and the passages of future laws; ● acceptance of our business model by investors; ● the accuracy of our estimates regarding expenses and capital requirements; ● our ability to adequately support growth; ● our expectations related to the use of proceeds from this offering and prior offerings and other financing activitiesoffering; and ● • our estimates regarding expenses, future revenue, capital requirements and financial performance; • our ability to satisfy obtain supply of our capital needs. Forward-looking statements may also concern products and product candidates; • the scalability and commercial viability of our expectations manufacturing methods and processes; • developments and projections relating to our subsidiaries. We caution you that the foregoing list may not contain all of the competitors and our industry; and • other risks and uncertainties, including those listed or incorporated by reference in “Risk Factors.” Any forward-looking statements made in this prospectus supplement reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those discussed under “Risk Factors” and elsewhere and incorporated by reference in this prospectus supplement and the accompanying prospectuses or the information incorporated herein and thereinprospectus. We may not actually achieve the plansGiven these uncertainties, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our these forward-looking statements. Actual results Except as required by law, we assume no obligation to update or events could differ materially from the plans, intentions and expectations disclosed in the revise these forward-looking statements we make. We have included important factors for any reason, even if new information becomes available in the cautionary statements included in this prospectus supplement, the accompanying prospectuses and the information incorporated herein and therein, particularly in “Risk Factors,” that could cause actual results or events to differ materially from the forward-looking statements that we makefuture. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. You should read this prospectus supplement, the accompanying prospectuses, the documents that we incorporate by reference into this This prospectus supplement and the accompanying prospectusesprospectus also contain or incorporate by reference estimates, including projections, and other information concerning our Annual Report on Form 10-K for the year ended December 31industry, 2019our business, and the documents markets for certain diseases, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Information that we have filed as exhibits is based on estimates, forecasts, projections, market research, or similar methodologies is inherently subject to our filings with the SEC completely uncertainties and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwisecircumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, except as required we obtained this industry, business, market, and other data from reports, research surveys, studies, and similar data prepared by lawmarket research firms and other third parties, industry, medical and general publications, government data, and similar sources.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectuses prospectus, and the information documents incorporated by reference herein and therein by reference therein, contain forward-looking statements within the meaning of Section 27A of the federal securities lawsSecurities Act, which statements involve substantial risks and uncertaintiesSection 21E of the Exchange Act. All statements, statements other than statements of historical factsfacts contained in this prospectus supplement, included or the accompanying prospectus, and the documents incorporated by reference in this prospectus supplement herein and the accompanying prospectuses therein, including statements regarding our future results of operations and financial position, business strategy, development plans, planned preclinical studies and clinical trials, future eventsresults of preclinical studies and clinical trials, expected research and development costs, regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would” and similar expressions are intended to In some cases, you can identify forward-looking statementsstatements by terminology such as “may”, although not all forward-looking statements contain “will”, “should”, “expects”, “intends”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, “continue” or the negative of these identifying wordsterms or other comparable terminology. These forward-looking statements include, among other thingsbut are not limited to, statements about: : ● • the ability of our lack preclinical studies and planned clinical trials to demonstrate safety and efficacy of operating history our product candidates, and history other positive results; • our ability to utilize our proprietary drug discovery platform to develop a pipeline of operating lossesproduct candidates to address muscle disorders; ● • the timing, progress and results of preclinical studies and clinical trials for EDG-5506, product candidates in our anticipated EDG-5440 and EDG-002 programs, and other product candidates we may develop, including statements regarding the timing for clinical development, regulatory submissions, commencement of initiation and completion of clinical studies or trials and product approvals; ● related preparatory work, the period during which the results of the studies or trials will become available, and our research and development programs; • the timing, scope and likelihood of regulatory filings and approvals, including timing of INDs and final FDA approval of EDG-5506, product candidates in our EDG-5440 and EDG-002 programs and any other future product candidates; • the timing, scope or likelihood of foreign regulatory filings and approvals; • our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical studies; • our manufacturing, commercialization, and marketing capabilities and strategy; • our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy; • the need to hire additional personnel and our ability to attract and retain such personnel; • the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting and our expectations regarding the implementation of newborn screening for muscular dystrophy; • our expectations regarding the approval and use of our product candidates in combination with other drugs; • our competitive position and the success of competing therapies that are or may become available; • our estimates of the number of patients that we will enroll in our clinical trials; • the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of our product candidates; • our ability to obtain and maintain regulatory approval of our product candidates; • our plans relating to the further development of our product candidates, including additional indications we may pursue; • existing regulations and regulatory developments in the United States, Europe and other jurisdictions; • our expectations regarding the impact of the COVID-19 pandemic on our business; • our intellectual property position, including the possibility scope of unfavorable clinical trial results or that results from our clinical trials will differ from results in past clinical trials; ● actual or anticipated variations protection we are able to establish and maintain for intellectual property rights covering EDG-5506, product candidates in our operating results; ● our cash position; ● market conditions in our industry; ● EDG-5440 and EDG-002 programs, and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to complete required infringe, misappropriate or otherwise violate any third-party intellectual property rights; • our continued reliance on third parties to conduct additional preclinical studies and planned clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and obtain approval from clinical trials; • our relationships with patient advocacy groups, key opinion leaders, regulators, the FDA or other regulatory agencies in different jurisdictionsresearch community and payors; ● the potential impact of the COVID-19 pandemic, including sustained social distancing efforts, on our operations, including our clinical development plans and timelines; ● • our ability to maintain obtain, and negotiate favorable terms of, any collaboration, licensing or protect other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; • the validity pricing and reimbursement of EDG-5506, product candidates in our patents EDG-5440 and EDG-002 programs, and other intellectual propertyproduct candidates we may develop, if approved; ● • the rate and degree of market acceptance and clinical utility of EDG-5506, product candidates in our ability to retain key personnel; ● our ability to internally develop new inventions EDG-5440 and intellectual property; ● interpretations of current laws and the passages of future laws; ● acceptance of our business model by investors; ● the accuracy of our estimates regarding expenses and capital requirements; ● our ability to adequately support growth; ● our expectations related to the use of proceeds from this offering and prior offerings EDG-002 programs, and other financing activitiesproduct candidates we may develop; and ● • our estimates regarding expenses, future revenue, capital requirements and ability needs for additional financing; • our financial performance; • the period over which we estimate our existing cash and cash equivalents will be sufficient to satisfy fund our future operating expenses and capital needs. Forward-looking statements may also concern expenditure requirements; • the impact of laws and regulations; • our expectations relating regarding the period during which we will qualify as an emerging growth company under The Jumpstart Our Business Startups Act of 2012 and a smaller reporting company under the Securities Exchange Act of 1934, as amended; • our anticipated use of our existing cash, cash equivalents, and marketable securities; and • our expectations related to our subsidiariesthe use of proceeds from this offering. We caution you that the foregoing list may not contain all of the have based these forward-looking statements made largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward- looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this prospectus supplement and the accompanying prospectuses or the information incorporated herein are subject to a number of risks, uncertainties and therein. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed assumptions described in the forward-looking statements we make. We have included important factors in the cautionary statements included section titled “Risk Factors” and elsewhere in this prospectus supplement, the accompanying prospectuses prospectus, and the information documents incorporated by reference herein and therein. Because forward-looking statements are inherently subject to risks and uncertainties, particularly some of which cannot be predicted or quantified, you should not rely on these forward- looking statements as predictions of future events. The events and circumstances reflected in “Risk Factors,” that could cause our forward-looking statements may not be achieved or occur and actual results or events to could differ materially from those projected in the forward-looking statements that statements. Except as required by applicable law, we make. Our do not plan to publicly update or revise any forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that contained herein until after we may make. You should read distribute this prospectus supplement, the accompanying prospectuses, the documents that we incorporate by reference into this prospectus supplement and the accompanying prospectuses, including our Annual Report on Form 10-K for the year ended December 31, 2019, and the documents that we have filed as exhibits to our filings with the SEC completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of any new information, future events or otherwise. In addition, except statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as required by lawof the date of this prospectus supplement and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, supplement and the accompanying prospectuses and prospectus, the information incorporated by reference herein and therein by reference and any free writing prospectus that we have authorized for use in connection with this offering contain or may contain forward-looking statements within the meaning of Section 27A of the federal securities lawsSecurities Act, which statements and Section 21E of the Exchange Act, that involve substantial a number of risks and uncertainties. All statementsAlthough our forward-looking statements reflect the good faith judgment of our management, other than these statements of historical factscan only be based on facts and factors currently known by us. Consequently, included or incorporated by reference these forward-looking statements are inherently subject to risks and uncertainties, and actual results and outcomes may differ materially from results and outcomes discussed in this prospectus supplement and the accompanying prospectuses regarding our strategy, future events, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. The Forward-looking statements may include, but are not limited to, statements about: • our ability to successfully commercialize OLINVYK and our other product candidates; • our ability to generate sales and other revenues from OLINVYK or any of our other product candidates, if and when approved, including setting an acceptable price for and obtaining adequate coverage and hospital formulary acceptance of such products; • the size and growth potential of the markets for OLINVYK and our ability to serve those markets; • any ongoing or planned clinical trials and preclinical studies for our other product candidates; • the extent of future clinical trials potentially required by the FDA for our product candidates; • our ability to fund future operating expenses and capital expenditures with our current cash resources or to secure additional funding in the future; • the timing and likelihood of obtaining and maintaining regulatory approvals for our other product candidates; • the direct and indirect impact of the COVID-19 pandemic on our business and operations, including research and development costs, our clinical trial timelines and our ability to successfully commercialize and secure market acceptance of OLINVYK; • the performance of third-parties upon which we may depend, including third-party manufacturers, distributors and logistics providers; • the clinical utility and market acceptance of our product candidates, particularly in light of existing and future competition; • our sales, marketing, and manufacturing capabilities and strategies; • our intellectual property position; • ongoing litigation; and • our ability to identify additional product candidates with significant commercial potential that are consistent with our commercial objectives. Forward-looking statements can be identified by the use of forward-looking words such as “anticipatebelieves,” “believeexpects,” “estimate,” “expect,” “intendhopes,” “may,” “will,” “plan,” “predictintends,” “projectestimates,” “could,” “should,” “would,” “continue,” “seeks,” “pro forma,” or “anticipates,” or other similar words (including their use in the negative), or by discussions of future matters such as the development of new products, technology enhancements, possible collaborations and other statements that are not historical. These statements include but are not limited to statements under the captions “Business,” “Risk Factors” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in other things, statements about: : ● our lack of operating history and history of operating losses; ● our anticipated timing for clinical development, regulatory submissions, commencement and completion of clinical trials and product approvals; ● the results of our clinical trials, including the possibility of unfavorable clinical trial results or that results sections incorporated by reference from our clinical trials will differ from Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as applicable, as well as our other filings with the SEC. You should be aware that the occurrence of any of the events discussed under the heading “Risk Factors” in this prospectus supplement and any documents incorporated by reference herein and in the accompanying prospectus could substantially harm our business, operating results in past clinical trials; ● actual or anticipated variations and financial condition and that if any of these events occurs, it could adversely affect the value of an investment in our operating results; ● our cash position; ● market conditions in our industry; ● our ability to complete required clinical trials of our product candidates and obtain approval from the FDA or other regulatory agencies in different jurisdictions; ● the potential impact of the COVID-19 pandemic, including sustained social distancing efforts, on our operations, including our clinical development plans and timelines; ● our ability to maintain or protect the validity of our patents and other intellectual property; ● our ability to retain key personnel; ● our ability to internally develop new inventions and intellectual property; ● interpretations of current laws and the passages of future laws; ● acceptance of our business model by investors; ● the accuracy of our estimates regarding expenses and capital requirements; ● our ability to adequately support growth; ● our expectations related to the use of proceeds from this offering and prior offerings and other financing activities; and ● our estimates regarding expenses, future revenue, capital requirements and ability to satisfy our capital needssecurities. Forward-looking statements may also concern our expectations relating to our subsidiaries. We caution you that the foregoing list may not contain all of the forward-looking The cautionary statements made in this prospectus supplement and the accompanying prospectuses or the information incorporated herein and therein. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the prospectus are intended to be applicable to all related forward-looking statements we make. We have included important factors in the cautionary statements included wherever they may appear in this prospectus supplement, the accompanying prospectuses and the information prospectus or any documents incorporated herein and therein, particularly in “Risk Factors,” that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. You should read this prospectus supplement, the accompanying prospectuses, the documents that we incorporate by reference into this prospectus supplement and the accompanying prospectuses, including our Annual Report on Form 10-K for the year ended December 31, 2019, and the documents that we have filed as exhibits to our filings with the SEC completely and with the understanding that our actual future results may be materially different from what we expectherein or therein. We do urge you not assume any obligation to update any place undue reliance on these forward-looking statements, whether which speak only as a result of new information, future events or otherwise, except the date they are made. Except as required by law, we assume no obligation to update our forward-looking statements, even if new information becomes available in the future.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectuses and the information documents we have filed with the SEC that are incorporated herein and therein by reference contain “forward-looking statements statements” within the meaning of Section 27A of the federal securities lawsSecurities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements involve substantial may include, but are not limited to, statements about: • future operating or financial results; • the effect of the COVID-19 pandemic on our business, operations and supply chain, including the potential impact on our clinical trial plans and timelines, such as the enrollment, activation and initiation of additional clinical trial sites, and the results of our clinical trials; • future acquisitions, business strategy and expected capital spending; • the timing, progress, costs and results of our clinical trials for IMVT-1401, including our ASCEND MG, ASCEND GO and ASCEND WAIHA trials; • the timing of meetings with and feedback from regulatory authorities as well as any submission of filings for regulatory approval of IMVT-1401; • the potential advantages and differentiated profile of IMVT-1401 compared to existing therapies for the applicable indications; • our ability to successfully manufacture or have manufactured drug product for clinical trials and commercialization; • our ability to successfully commercialize IMVT-1401, if approved; • the rate and degree of market acceptance of IMVT-1401, if approved; • our expectations regarding the size of the patient populations for and opportunity for and clinical utility of IMVT-1401, if approved for commercial use; • our estimates of our expenses, ongoing losses, future revenue, capital requirements and needs for or ability to obtain future financing to complete the clinical trials for and commercialize IMVT-1401; • our dependence on and plans to leverage third parties for research and development, clinical trials, manufacturing and other activities; • our ability to maintain intellectual property protection for IMVT-1401; • our ability to identify, acquire or in-license and develop new product candidates; • our ability to identify, recruit and retain key personnel; • our use of the net proceeds from the sale of the shares of common stock offered hereby; • developments and projections relating to our competitors or industry; and • future payments of dividends and the availability of cash for payment of dividends. These risks are not exhaustive. Other sections of this prospectus may include additional factors that could harm our business and uncertaintiesfinancial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. All statements, statements other than statements of historical facts, included or incorporated by reference facts contained in this prospectus supplement and the accompanying prospectuses prospectus, including statements regarding our strategyfuture financial condition, future eventsbusiness strategy and plans, and objectives of management for future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. The In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “projectshould,” “wouldwill” and or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying wordsexpressions. These forward-looking statements includereflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, among other things, statements about: : ● our lack of operating history and history of operating losses; ● our anticipated timing for clinical development, regulatory submissions, commencement and completion of clinical trials and product approvals; ● the results of our clinical trials, including the possibility of unfavorable clinical trial results or that results from our clinical trials will differ from results in past clinical trials; ● actual or anticipated variations in our operating results; ● our cash position; ● market conditions in our industry; ● our ability to complete required clinical trials of our product candidates and obtain approval from the FDA or other regulatory agencies in different jurisdictions; ● the potential impact of the COVID-19 pandemic, including sustained social distancing efforts, on our operations, including our clinical development plans and timelines; ● our ability to maintain or protect the validity of our patents and other intellectual property; ● our ability to retain key personnel; ● our ability to internally develop new inventions and intellectual property; ● interpretations of current laws and the passages of future laws; ● acceptance of our business model by investors; ● the accuracy of our estimates regarding expenses and capital requirements; ● our ability to adequately support growth; ● our expectations related to the use of proceeds from this offering and prior offerings and other financing activities; and ● our estimates regarding expenses, future revenue, capital requirements and ability to satisfy our capital needs. Forward-looking statements may also concern our expectations relating to our subsidiaries. We caution you that the foregoing list may not contain all of the forward-looking statements made in this prospectus supplement and the accompanying prospectuses or the information incorporated herein and therein. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our these forward-looking statements. Actual results or events could differ materially from We discuss in greater detail many of these risks under the planssection titled “Risk Factors” contained in this prospectus, intentions in any free writing prospectuses we may authorize for use in connection with a specific offering, and expectations disclosed in our most recent annual report on Form 10-K and in our most recent quarterly report on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC, which are incorporated by reference into this prospectus in their entirety. Also, these forward-looking statements represent our estimates and assumptions only as of the date of the document containing the applicable statement. Unless required by law, we make. We have included important factors in the cautionary statements included in this prospectus supplement, the accompanying prospectuses and the information incorporated herein and therein, particularly in “Risk Factors,” that could cause actual results undertake no obligation to update or events to differ materially from the revise any forward-looking statements that we make. Our forward-looking statements do not to reflect the potential impact of any new information or future acquisitions, mergers, dispositions, joint ventures events or investments that we may makedevelopments. You should read this prospectus supplement, the accompanying prospectuses, together with the documents that we incorporate by reference into this prospectus supplement and the accompanying prospectuses, including our Annual Report on Form 10-K for the year ended December 31, 2019, and the documents that we have filed as exhibits to our filings with the SEC that are incorporated by reference and any free writing prospectus that we may authorize for use in connection with this offering completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any qualify all of the forward-looking statements in the foregoing documents by these cautionary statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements, whether as a result of new such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information, future events or otherwise, except as required by law. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectuses and prospectus, including the information documents incorporated by reference herein and therein by reference therein, and any free writing prospectus that we have authorized for use in connection with this offering contain forward-looking statements within the meaning of the federal securities lawsPrivate Securities Litigation Reform Act of 1995 concerning our business, which operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements involve substantial risks and uncertainties. All statements, other than contained herein that are not statements of historical facts, included or incorporated by reference in this prospectus supplement and the accompanying prospectuses regarding our strategy, future events, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are facts may be deemed to be forward-looking statements. The words In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “projectpotential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are intended to identify forward-looking statementspredictions or indicate future events and future trends, although not all forward-looking statements contain or the negative of these identifying wordsterms or other comparable terminology. These forward-looking statements include, among other thingsbut are not limited to, statements about: : ● ∎ our lack of operating history expectations regarding the potential benefits, activity, effectiveness and history of operating losses; ● our anticipated timing for clinical development, regulatory submissions, commencement and completion of clinical trials and product approvals; ● the results of our clinical trials, including the possibility of unfavorable clinical trial results or that results from our clinical trials will differ from results in past clinical trials; ● actual or anticipated variations in our operating results; ● our cash position; ● market conditions in our industry; ● our ability to complete required clinical trials safety of our product candidates and obtain approval from therapeutics developed utilizing our Probody platform technology; ∎ the FDA or other initiation, timing, progress and results of our ongoing clinical trials, research and development programs, preclinical studies, and regulatory agencies in different jurisdictionssubmissions, including Investigational New Drug (“IND”) applications, Clinical Trial Applications, New Drug Applications (“NDA”) and, Biologics License Applications (“BLA”); ● ∎ the potential impact timing of the COVID-19 pandemic, including sustained social distancing efforts, on completion of our operations, including our ongoing clinical development plans trials and timelinesthe timing and availability of clinical data from such clinical trials; ● ∎ our ability to identify and develop additional product candidates; ∎ our dependence on collaborators for developing, obtaining regulatory approval for and commercializing product candidates in the collaboration; ∎ our or a collaborator’s ability to obtain and maintain or protect the validity regulatory approval of any of our patents product candidates; ∎ our receipt and other intellectual propertytiming of any milestone payments or royalties under any research collaboration and license agreements or arrangements; ● ∎ our expectations and beliefs regarding the evolution of the market for cancer therapies and development of the immuno-oncology industry; ∎ the rate and degree of market acceptance of any approved product candidates; ∎ the commercialization of any approved product candidates; ∎ our ability to establish and maintain collaborations and retain key personnelcommercial rights for our product candidates in such collaborations; ● our ability to internally develop new inventions and intellectual property; ● interpretations of current laws and ∎ the passages of future laws; ● acceptance implementation of our business model by investorsand strategic plans for our business, technologies and product candidates; ● the accuracy ∎ our estimates of our estimates regarding expenses expenses, ongoing losses, future revenue and capital requirements; ● ∎ our ability to adequately support growthobtain additional funds for our operations; ● ∎ our expectations related or any collaborator’s ability to obtain and maintain intellectual property protection for our technologies and product candidates and our ability to operate our business without infringing, misappropriating or otherwise violating the use intellectual property rights of proceeds from this offering others; ∎ our reliance on third parties to conduct our preclinical studies or any future clinical trials; ∎ our reliance on third-party supply and prior offerings manufacturing partners to supply the materials and other financing activitiescomponents for, and manufacture, our research and development, preclinical and clinical trial product supplies; ∎ our ability to attract and retain qualified key management and technical personnel; ∎ our ability to secure and maintain licenses of intellectual property to protect our technologies and product candidates; ∎ our financial performance; and ● our estimates regarding expenses, future revenue, capital requirements and ability to satisfy our capital needs. Forward-looking statements may also concern our expectations ∎ developments relating to our subsidiaries. We caution you that the foregoing list may not contain all of the forward-looking statements made in this prospectus supplement and the accompanying prospectuses competitors or the information incorporated herein and therein. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus supplement, the accompanying prospectuses and the information incorporated herein and therein, particularly in “Risk Factors,” that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may makeindustry. You should read this prospectus supplement, the accompanying prospectuses, the documents that we incorporate by reference into this prospectus supplement and the accompanying prospectuses, including our Annual Report on Form 10-K for the year ended December 31, 2019prospectus, and the documents that we have filed as exhibits to our filings with the SEC incorporated by reference herein completely and with the understanding that our actual future results may be differ materially different from what we expectexpect as expressed or implied by our forward-looking statements. In light of the significant risks and uncertainties to which our forward-looking statements are subject, you should not place undue reliance on or regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. We do not assume discuss many of these risks in greater detail in the documents incorporated by reference herein, including under the heading “Risk Factors.” These forward-looking statements represent our estimates and assumptions only as of the dates of this prospectus supplement, the accompanying prospectus and the documents incorporated by reference herein and therein, and any free writing prospectus, as applicable, regardless of the time of delivery of this prospectus supplement or any sale of our common stock and, except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwiseotherwise after the date of this prospectus supplement. For all forward-looking statements, except as required by lawwe claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectuses supplement includes and the information incorporated herein and therein incorporates by reference contain “forward-looking statements statements” within the meaning of the federal securities lawsU.S. Private Securities Litigation Reform Act of 1995 and releases issued by the SEC and within the meaning of Section 27A of the Securities Act, which and Section 21E of the Exchange Act. Any statements involve substantial risks and uncertainties. All statements, other than contained herein that are not statements of historical facts, included or incorporated by reference in this prospectus supplement and the accompanying prospectuses regarding our strategy, future events, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are facts may be deemed to be forward-looking statements. The words In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “due,” “estimate,” “expect,” “intend,” “may,” “objective,” “plan,” “predict,” “projectpotential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are intended to identify forward-looking statementspredictions of or indicate future events and future trends, although not all forward-looking statements contain or the negative of these identifying wordsterms or similar language. These forward-Forward- looking statements include, among other thingsbut are not limited to, statements about: : ● • our lack expectations regarding the timing, progress and results clinical trials for TPST-1495 and TPST-1120 and preclinical studies for TREX-1 and any other product candidates we develop, including statements regarding the timing of operating history and history of operating losses; ● our anticipated timing for clinical development, regulatory submissions, commencement initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; • the timing or likelihood of regulatory filings for TPST-1495, TPST-1120 and TREX-1 and any other product candidates we develop and our ability to obtain and maintain regulatory approvals for such product candidates for any indication; • our manufacturing capabilities and strategy, including the scalability of our manufacturing methods and processes; • our expectations regarding the potential benefits, activity, effectiveness and safety of TPST-1495, TPST-1120 and TREX-1 and any other product candidates we develop; • our intentions and ability to successfully commercialize our product candidates; • our estimates regarding our expenses, future revenues, capital requirements, our needs for or ability to obtain additional financing and the period over which we expect our current cash, cash equivalents and marketable securities to be sufficient to fund our operations; • our intended reliance on and the performance of third parties, including collaborators, contract research organizations and third-party manufacturers; • our ability to protect and enforce our intellectual property protection and the scope and duration of such protection; • developments and projections relating to our competitors and our industry, including competing therapies; • the introduction of technological innovations or new therapies that compete with our products and services; • the impact of the COVID-19 pandemic on the initiation (including the emergence of variant strains), progress or expected timing of our clinical trials and product approvals; ● the results timing of related data, our clinical trials, including efforts to adjust trial-related activities to address the possibility of unfavorable clinical trial results or that results from our clinical trials will differ from results in past clinical trials; ● actual or anticipated variations in our operating results; ● our cash position; ● market conditions in our industry; ● our ability to complete required clinical trials of our product candidates and obtain approval from the FDA or other regulatory agencies in different jurisdictions; ● the potential impact of the COVID-19 pandemic, including sustained social distancing efforts, on our operations, including our clinical development plans and timelines; ● our ability to maintain or protect the validity of our patents and other intellectual propertyfuture impacts of the COVID-19 pandemic on the economy, our industry and our financial condition and results of operations; ● our ability to retain key personnel; ● our ability to internally develop new inventions and intellectual property; ● interpretations • the impact of current and future laws and the passages of future lawsregulations; ● acceptance of and • our business model by investors; ● the accuracy of our estimates regarding expenses and capital requirements; ● our ability to adequately support growth; ● our expectations related to the intended use of proceeds from this offering offering. These statements are based on management’s current expectations, estimates, forecasts and prior offerings projections about our business and industry, are not guarantees of future performance and involve known and unknown risks, uncertainties and other financing activities; factors that are in some cases beyond our control, such as the impacts of the COVID-19 pandemic, and ● that may cause our estimates regarding expensesor our industry’s actual results, future revenuelevels of activity, capital requirements and ability performance or achievements to satisfy our capital needs. Forward-looking statements may also concern our expectations relating to our subsidiaries. We caution you that the foregoing list may not contain all of be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in greater detail in the section entitled “Risk Factors” and elsewhere in this prospectus supplement. You should read these factors and the other cautionary statements made in this prospectus supplement and the accompanying prospectuses or the information incorporated herein and therein. We may not actually achieve the plans, intentions or expectations disclosed in our as being applicable to all related forward-looking statementsstatements wherever they appear herein or therein. If one or more of these factors materialize, and you should not place undue reliance on or if any underlying assumptions prove incorrect, our actual results, levels of activity, performance, or achievements may vary materially from any future results, activity, performance, or achievements expressed or implied by these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the We caution readers not to place undue reliance on any forward-looking statements we makemade by us, which speak only as of the date they were made. We have included important factors in undertake no obligation to publicly update any forward- looking statements after the cautionary statements included in date of this prospectus supplement, the accompanying prospectuses and the information incorporated herein and thereinwhether as a result of new information, particularly in “Risk Factors,” that could cause actual results future events or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitionsotherwise, mergers, dispositions, joint ventures or investments that we may makeexcept as required by law. You should read this prospectus supplement, supplement together with the accompanying prospectuses, the prospectus and documents that we incorporate by reference into this prospectus supplement and the accompanying prospectuses, including our Annual Report on Form 10-K for the year ended December 31, 2019, and the documents that we have filed as exhibits to our filings with the SEC that are incorporated by reference and any free writing prospectus that we may authorize for use in connection with this offering completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any qualify all of the forward-looking statements in the foregoing documents by these cautionary statements, whether as a result of new information, future events or otherwise, except as required by law.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectuses base prospectus and the information documents incorporated herein and therein by reference herein contain “forward-looking statements statements” within the meaning of Section 27A of the federal securities lawsSecurities Act, which and Section 21E of the Securities Exchange Act of 1934, as amended, or the “Exchange Act. These statements involve substantial risks reflect our current views with respect to our ongoing and uncertaintiesplanned pre-clinical and clinical trials, business strategy, business plan, financial performance and other future events including statements regarding the progress and timing of our product development, the goals of our development activities, estimates of the potential markets for our product candidates, estimates of the capacity of manufacturing and other facilities to support our products, our expected future revenues, operations and expenditures and projected cash needs. All statementsThe forward- looking statements are contained principally in the sections of this prospectus supplement, other than statements of historical facts, included or the accompanying base prospectus and the documents incorporated by reference in this prospectus supplement entitled “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and the accompanying prospectuses regarding Analysis of Financial Condition and Results of Operations” and “Business.” These statements relate to future events of our strategyfinancial performance and involve known and unknown risks, future eventsuncertainties and other factors that could cause our actual results, future operationslevels of activity, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are performance or achievement to differ materially from those expressed or implied by these forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would” Those risks and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements uncertainties include, among other thingsothers: · our ability to implement our business plan; · our ability to raise additional capital to meet our liquidity needs; · our ability to generate sufficient proceeds from this offering; · our ability to generate product revenues; · our ability to achieve profitability; · our ability to satisfy U.S., statements about: : ● including the Food and Drug Administration, or the FDA, and international regulatory requirements; · our lack ability to obtain market acceptance of operating history our technology and history of operating lossesproducts; ● · our anticipated timing for clinical development, regulatory submissions, commencement and completion of clinical trials and product approvalsability to compete in the market; ● the results of · our ability to advance our clinical trials; · our ability to fund, including the possibility of unfavorable clinical trial results or that results from our clinical trials will differ from results in past design and implement clinical trials; ● actual or anticipated variations in our operating results; ● our cash position; ● market conditions in our industry; ● · our ability to complete required clinical trials of demonstrate that our product candidates are safe for human use and obtain approval from the FDA or other regulatory agencies in different jurisdictionseffective for indicated uses; ● the potential impact of the COVID-19 pandemic, including sustained social distancing efforts, on our operations, including our clinical development plans and timelines; ● · our ability to maintain or protect the validity gain acceptance of physicians and patients for use of our products; · our dependency on third-party researchers and manufacturers and licensors; · our ability to effectively implement cost-cutting measures; · our ability to establish and maintain strategic partnerships, including for the distribution of products; · our ability to attract and retain sufficient, qualified personnel; · our ability to obtain or maintain patents and or other appropriate protection for the intellectual property; ● · our ability dependency on the intellectual property licensed to retain key personnelus or possessed by third parties; ● our ability to internally develop new inventions and intellectual property; ● interpretations of current laws and the passages of future laws; ● acceptance of our business model by investors; ● the accuracy of our estimates regarding expenses and capital requirements; ● · our ability to adequately support future growth; ● · our expectations related ability to maintain our Nasdaq listing; · the use impact of proceeds from this offering the COVID-19 pandemic on our business and prior offerings and other financing activitiesoperations; and ● · potential product liability or intellectual property infringement claims. Please consider our estimates regarding expenses, future revenue, capital requirements and ability to satisfy our capital needs. Forward-looking statements may also concern our expectations relating to our subsidiaries. We caution you that the foregoing list may not contain all of the forward-looking statements made in light of those risks as you read this prospectus supplement supplement, the accompanying base prospectus and the accompanying prospectuses documents incorporated by reference into this prospectus supplement. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the information incorporated herein and therein. We extent to which any factor, or combination of factors, may not actually achieve the plans, intentions or expectations disclosed cause actual results to differ materially from those contained in our any forward-looking statementsstatements we may make. Given these uncertainties, and you should not place undue reliance on our these forward-looking statements. Actual results or events could differ materially from You should not assume that the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included information contained in this prospectus supplement, supplement is accurate as of any date other than as of the accompanying prospectuses and the date of this prospectus supplement or that any information incorporated herein and therein, particularly in “Risk Factors,” that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. You should read this prospectus supplement, the accompanying prospectuses, the documents that we incorporate by reference into this prospectus supplement and is accurate as of any date other than the accompanying prospectusesdate of the document so incorporated by reference. Except as required by law, including our Annual Report on Form 10-K for the year ended December 31, 2019, and the documents that we have filed as exhibits to our filings with the SEC completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any no obligation to update any these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as a result expressed or implied in such forward-looking statements. If one or more of new informationthese or other risks or uncertainties materializes, future events or otherwiseif our underlying assumptions prove to be incorrect, except as required actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by lawthis Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and the documents incorporated by reference into this prospectus supplement that could cause actual results to differ.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectuses prospectus and the information documents incorporated by reference herein and therein by reference contain forward-looking statements. These are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Any statements in this prospectus supplement and the accompanying prospectus, or incorporated herein or therein, about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements within the meaning of Section 27A of the federal securities lawsSecurities Act of 1933, which statements involve substantial risks as amended, or the Securities Act, and uncertaintiesSection 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, included or incorporated by reference in this prospectus supplement and the accompanying prospectuses regarding our strategy, future events, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are These forward-looking statementsstatements include statements regarding: · the timing of, and our ability to obtain and maintain regulatory approval of, Eversense in the United States; · our ability to maintain regulatory approval of Eversense and Eversense XL in Europe; · the clinical utility of Eversense; · our ability to develop future generations of Eversense; · our ability to access our credit facilities in the future; · the timing and availability of data from our clinical trials; · the timing of our planned regulatory filings; · our future development priorities; · our ability to obtain adequate reimbursement and third-party payor coverage for Eversense; · our expectations about the willingness of healthcare providers to recommend Eversense to people with diabetes; · our commercialization, marketing and manufacturing capabilities and strategy; · our ability to comply with applicable regulatory requirements; · our ability to maintain our intellectual property position; · our estimates regarding the size of, and future growth in, the market for CGM systems; · proceeds from this offering; · our estimates regarding the period of time for which our current capital resources will be sufficient to fund our continued operations; and · our estimates regarding our future expenses and needs for additional financing. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would” and similar expressions are intended to In some cases, you can identify forward-looking statementsstatements by the words ‘‘may,’’ ‘‘might,’’ ‘‘can,’’ ‘‘will,’’ ‘‘to be,’’ ‘‘could,’’ ‘‘would,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘plan,’’ ‘‘objective,’’ ‘‘anticipate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘potential,’’ ‘‘likely,’’ ‘‘continue’’ and ‘‘ongoing,’’ or the negative of these terms, or other comparable terminology intended to identify statements about the future, although not all forward-looking statements contain these identifying words. These forward-looking statements includeinvolve known and unknown risks, among uncertainties and other thingsfactors that may cause our actual results, statements about: : ● our lack levels of operating history and history of operating losses; ● our anticipated timing for clinical developmentactivity, regulatory submissions, commencement and completion of clinical trials and product approvals; ● the results of our clinical trials, including the possibility of unfavorable clinical trial results performance or that results from our clinical trials will differ from results in past clinical trials; ● actual or anticipated variations in our operating results; ● our cash position; ● market conditions in our industry; ● our ability achievements to complete required clinical trials of our product candidates and obtain approval be materially different from the FDA information expressed or other regulatory agencies in different jurisdictions; ● the potential impact of the COVID-19 pandemic, including sustained social distancing efforts, on our operations, including our clinical development plans and timelines; ● our ability to maintain or protect the validity of our patents and other intellectual property; ● our ability to retain key personnel; ● our ability to internally develop new inventions and intellectual property; ● interpretations of current laws and the passages of future laws; ● acceptance of our business model implied by investors; ● the accuracy of our estimates regarding expenses and capital requirements; ● our ability to adequately support growth; ● our expectations related to the use of proceeds from this offering and prior offerings and other financing activities; and ● our estimates regarding expenses, future revenue, capital requirements and ability to satisfy our capital needs. Forward-looking statements may also concern our expectations relating to our subsidiaries. We caution you that the foregoing list may not contain all of the forward-looking statements made in this prospectus supplement and the accompanying prospectuses or the information incorporated herein and therein. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our these forward-looking statements. Actual results or events could differ materially from You should refer to the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus supplement, the accompanying prospectuses and the information incorporated herein and therein, particularly in “‘‘Risk Factors,” that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. You should read this prospectus supplement, the accompanying prospectuses, ’’ section contained in the documents that we incorporate are incorporated by reference into this prospectus supplement and the accompanying prospectusesprospectus, including for a discussion of important factors that may cause our Annual Report on Form 10actual results to differ materially from those expressed or implied by our forward-K for looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the year ended December 31inaccuracy may be material. In light of the significant uncertainties in these forward- looking statements, 2019, and the documents you should not regard these statements as a representation or warranty by us or any other person that we have filed will achieve our objectives and plans in any specified time frame, or at all. Except as exhibits to our filings with the SEC completely and with the understanding that our actual future results may be materially different from what required by law, we expect. We do not assume any no obligation to update any forward-looking statementsstatements publicly, whether as a result of new information, future or to revise any forward-looking statements to reflect events or otherwisedevelopments occurring after the date of this prospectus supplement, even if new information becomes available in the future. RATIO OF EARNINGS TO FIXED CHARGES The following table sets forth our ratio of earnings to fixed charges for each of the periods presented. Our net losses were insufficient to cover fixed charges for each of the periods presented. Because of these deficiencies, the ratio information is not applicable for those periods. The extent to which earnings were insufficient to cover fixed charges for those periods is shown below. Amounts are shown in thousands, except as required by law.for ratios. Year Ended December 31, Nine Months Ended 2014 2015 2016 September 30, 2017 Ratio of earnings to fixed charges(1) X/X X/X X/X X/X Deficiency of earnings available to cover fixed charges $ (19,076) $ (31,384) $ (45,532) $ (45,191)

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectuses and the information documents incorporated herein and therein by reference contain forward-looking statements. These are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward-looking statements within may be found, among other places, in the meaning Sections entitled ‘‘Business,’’ ‘‘Risk Factors’’ and ‘‘Management’s Discussion and Analysis of the federal securities laws, which statements involve substantial risks Financial Condition and uncertainties. All statements, other than statements Results of historical facts, included or Operations’’ incorporated by reference from our most recent Annual Report on Form 10‑K and in our Quarterly Reports on Form 10‑Q, as well as any amendments thereto, filed with the SEC. Any statements in this prospectus supplement and the accompanying prospectuses regarding prospectus, or incorporated herein, about our strategyexpectations, future events, future operations, future financial position, future revenue, projected costs, prospectsbeliefs, plans, objectives of management objectives, assumptions or future events or performance are not historical facts and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would” Within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and similar expressions are intended Section 21E of the Exchange Act, these forward-looking statements include statements regarding: · the timing and availability of data from our clinical trials; · the timing of our planned regulatory filings; · the timing of and our ability to obtain and maintain regulatory approval of Eversense; · the clinical utility of Eversense; · our ability to develop future generations of Eversense; · our ability to access our credit facilities in the future; · our future development priorities; · our ability to obtain adequate reimbursement and third-party payor coverage for Eversense; · our expectations about the willingness of healthcare providers to recommend Eversense to people with diabetes; · our commercialization, marketing and manufacturing capabilities and strategy; · our ability to comply with applicable regulatory requirements; · our ability to maintain our intellectual property position; · our estimates regarding the size of, and future growth in, the market for CGM systems; · our estimates regarding the period of time for which our current capital resources will be sufficient to fund our continued operations; and · our estimates regarding our future expenses and needs for additional financing. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. In some cases, you can identify forward-looking statementsstatements by the words ‘‘may,’’ ‘‘might,’’ ‘‘can,’’ ‘‘will,’’ ‘‘to be,’’ ‘‘could,’’ ‘‘would,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘plan,’’ ‘‘objective,’’ ‘‘anticipate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘potential,’’ ‘‘likely,’’ ‘‘continue’’ and ‘‘ongoing,’’ or the negative of these terms, or other comparable terminology intended to identify statements about the future, although not all forward-looking statements contain these identifying words. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements includestatements. You should refer to the ‘‘Risk Factors’’ section contained in the applicable prospectus supplement and any related free writing prospectus, among and under similar headings in the other thingsdocuments that are incorporated by reference into this prospectus, statements about: : ● for a discussion of important factors that may cause our lack of operating history and history of operating losses; ● actual results to differ materially from those expressed or implied by our anticipated timing for clinical developmentforward-looking statements. Given these risks, regulatory submissions, commencement and completion of clinical trials and product approvals; ● the results of our clinical trials, including the possibility of unfavorable clinical trial results or that results from our clinical trials will differ from results in past clinical trials; ● actual or anticipated variations in our operating results; ● our cash position; ● market conditions in our industry; ● our ability to complete required clinical trials of our product candidates and obtain approval from the FDA or other regulatory agencies in different jurisdictions; ● the potential impact of the COVID-19 pandemic, including sustained social distancing efforts, on our operations, including our clinical development plans and timelines; ● our ability to maintain or protect the validity of our patents uncertainties and other intellectual property; ● factors, many of which are beyond our ability to retain key personnel; ● our ability to internally develop new inventions and intellectual property; ● interpretations of current laws and the passages of future laws; ● acceptance of our business model by investors; ● the accuracy of our estimates regarding expenses and capital requirements; ● our ability to adequately support growth; ● our expectations related to the use of proceeds from this offering and prior offerings and other financing activities; and ● our estimates regarding expensescontrol, future revenue, capital requirements and ability to satisfy our capital needs. Forward-looking statements may also concern our expectations relating to our subsidiaries. We caution we cannot assure you that the foregoing list may not contain all of the forward-looking statements made in this prospectus supplement and the accompanying prospectuses or the information incorporated herein and therein. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statementswill prove to be accurate, and you should not place undue reliance on our these forward-looking statements. Actual results or events could differ materially from the plansFurthermore, intentions and expectations disclosed in the forward-if our forward- looking statements we make. We have included important factors in the cautionary statements included in this prospectus supplementprove to be inaccurate, the accompanying prospectuses and the information incorporated herein and therein, particularly in “Risk Factors,” that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. You should read this prospectus supplement, the accompanying prospectuses, the documents that we incorporate by reference into this prospectus supplement and the accompanying prospectuses, including our Annual Report on Form 10-K for the year ended December 31, 2019, and the documents that we have filed as exhibits to our filings with the SEC completely and with the understanding that our actual future results inaccuracy may be materially different from what we expectmaterial. We do not assume any obligation to update any In light of the significant uncertainties in these forward-looking statements, whether you should not regard these statements as a result of new informationrepresentation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, future events or otherwise, except at all. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to revise any forward-looking statements to reflect events or developments occurring after the date of this prospectus, even if new information becomes available in the future.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectuses and the information documents incorporated herein and therein by reference herein contain forward-looking statements. These are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward-looking statements within may be found, among other places, in the meaning sections entitled “Business,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in the federal securities laws, which statements involve substantial risks and uncertainties. All statements, other than statements of historical facts, included or documents incorporated by reference herein. Any statements in this prospectus supplement and the accompanying prospectuses regarding prospectus, or incorporated herein, about our strategyexpectations, future events, future operations, future financial position, future revenue, projected costs, prospectsbeliefs, plans, objectives of management objectives, assumptions or future events or performance are not historical facts and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would” Within the meaning of Section 27A of the Securities Act and similar expressions are intended to identify forward-looking statementsSection 21E of the Securities Exchange Act of 1934, although not all as amended, or the Exchange Act, these forward-looking statements contain these identifying words. These forward-looking include statements include, among other things, statements about: regarding: ● the timing, progress and results of clinical trials of our lack Oral Mucositis therapy and other product candidates, including statements regarding the timing of operating history initiation and history completion of operating lossespreclinical studies or clinical trials or related preparatory work, the period during which the results of the trials will become available and our research and development programs; ● the timing of any submission of filings for regulatory approval of our product candidates and our ability to obtain and maintain regulatory approvals for our product candidates for any indication; ● our anticipated timing for clinical developmentexpectations regarding the potential benefits, regulatory submissionsactivity, commencement effectiveness and completion of clinical trials and product approvals; ● the results safety of our clinical trials, including the possibility of unfavorable clinical trial results or that results from our clinical trials will differ from results in past clinical trials; ● actual or anticipated variations in our operating resultsproduct candidates; ● our cash positionexpectations regarding the size of the patient populations, market acceptance and opportunity for and clinical utility of our product candidates, if approved for commercial use; ● market conditions in our industrymanufacturing capabilities and strategy, including the, scalability and commercial viability of our manufacturing methods and processes; ● our expectations regarding the scope of any approved indications for our product candidates; ● our ability to complete required clinical trials of successfully commercialize our product candidates and obtain approval from the FDA or other regulatory agencies in different jurisdictionscandidates; ● the potential impact benefits of the COVID-19 pandemic, including sustained social distancing efforts, on and our operations, including ability to maintain our clinical development plans relationships and timelinescollaborations with Intrexon and other potential collaboration or strategic relationships; ● our ability to maintain or protect the validity use our Oral Mucositis and Lantibiotic platforms to develop future product candidates; ● our estimates of our patents expenses, ongoing losses, future revenue, capital requirements and other intellectual propertyour needs for or ability to obtain additional funding; ● our ability to identify, recruit and retain key personnel; ● our ability to internally develop new inventions protect and enforce our intellectual propertyproperty position for our product candidates, and the scope of such protection; ● interpretations of current laws and the passages of future lawsour financial performance; ● acceptance our inability to achieve success in our identification of lantibiotic homologs or the manufacture and nonclinical testing of our business model lantibiotic product candidates. ● we are subject to extensive and costly regulation by investors; ● the accuracy Food and Drug Administration, which must approve our product candidates in development and could restrict or delay the future commercialization of certain of our estimates regarding expenses and capital requirements; product candidates. ● our ability to adequately support growth; successfully complete preclinical and clinical development of, and obtain regulatory approval of our product candidates and commercialize any approved products on our expected timeframes or at all. ● the safety, efficacy and benefits of our product candidates. ● the content and timing of submissions to and decisions made by the FDA and other regulatory agencies. ● the effects of government regulation and regulatory developments, and our ability and the ability of the third parties with whom we engage to comply with applicable regulatory requirements. ● the capacities and performance of our suppliers and manufacturers and other third parties over whom we have limited control. ● our expectations related ability to maintain our listing on the use NYSE American. ● our competitive position and the development of proceeds from this offering and prior offerings and other financing activitiesprojections relating to our competitors or our industry; and ● our estimates regarding expensesthe impact of laws and regulations. Except as required by law, future revenue, capital requirements and ability we assume no obligation to satisfy our capital needs. Forward-looking statements may also concern our expectations relating to our subsidiaries. We caution you that the foregoing list may not contain all of the update these forward-looking statements made in this prospectus supplement and the accompanying prospectuses publicly, or the information incorporated herein and therein. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the to revise any forward-looking statements we make. We have included important factors to reflect events or developments occurring after the date of this prospectus, even if new information becomes available in the cautionary statements included in this prospectus supplement, the accompanying prospectuses and the information incorporated herein and therein, particularly in “Risk Factors,” that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. You should read this prospectus supplement, the accompanying prospectuses, the documents that we incorporate by reference into this prospectus supplement and the accompanying prospectuses, including our Annual Report on Form 10-K for the year ended December 31, 2019, and the documents that we have filed as exhibits to our filings with the SEC completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by lawfuture.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectuses and the information documents incorporated herein and therein by reference contain forward-in this prospectus include forward- looking statements within the meaning of Section 27A of the federal securities lawsSecurities Act and Section 21E of the Exchange Act, which that relate to future events or to our future operations or financial performance. Any forward- looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements involve substantial risks and uncertainties. All include statements, other than statements of historical factsfact, included about, among other things: • our commercialization plans and expectations for commercializing Bylvay™ (odevixibat) globally; • the progress, number, scope, cost, duration or incorporated by reference results of our development activities, nonclinical studies and clinical trials of Bylvay, elobixibat, A3907, A2342, or any of our other product candidates or programs, such as the target indication(s) for development or approval, the size, design, population, conduct, cost, objective or endpoints of any clinical trial, or the timing for initiation or completion of or availability of results from any clinical trial (including BOLD, our pivotal clinical trial of Bylvay in this prospectus supplement patients with biliary atresia, or ASSERT, our pivotal trial of Bylvay in Alagille syndrome, or ALGS), for submission, review or approval of any regulatory filing, or for meeting with regulatory authorities; • the potential benefits that may be derived from any of our product candidates; • the timing of and our ability to obtain and maintain regulatory approval of our existing product candidates, any product candidates that we may develop, and any related restrictions, limitations, or warnings in the accompanying prospectuses regarding label of any approved product candidates; • any payment that EA Pharma may make to us or any other action or decision that EA Pharma may make concerning elobixibat or our strategy, future events, business relationship; • the potential impacts of the COVID-19 pandemic on our business operations or financial condition; • our future operations, future financial position, future revenuerevenues, projected costs, expenses, uses of cash, capital requirements, our need for additional financing or the period for which our existing cash resources will be sufficient to meet our operating requirements; or • our strategies, prospects, plans, objectives of management and expected market growth are forward-looking statementsexpectations, forecasts or objectives. The words Words such as, but not limited to, “anticipatebelieve,” “believeexpect,” “anticipate,” “estimate,” “expectforecast,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “targets,” “likely,” “will,” “would,” “could,” “should,” “continue,” “scheduled” and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These Although we believe that we have a reasonable basis for each forward-looking statement contained or incorporated by reference in this prospectus, we caution you that these statements includeare based on our estimates and projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking statement. Actual results, level of activity, performance, experience or achievements may differ materially from those expressed or implied by any forward-looking statement as a result of various important factors, including our critical accounting policies and risks and uncertainties relating, among other things, statements aboutto: : ● • our lack ability to effectively commercialize Bylvay for its approved indications; • the design, size, duration and endpoints for, and results from BOLD, our pivotal trial of operating history Bylvay in biliary atresia, and history ASSERT, our pivotal trial of operating lossesBylvay in ALGS, or any other trials that will be required to obtain marketing approval for Bylvay to treat patients with PFIC, biliary atresia, ALGS or any other pediatric cholestatic liver disease or for A3907 and A2342 as potential treatments for adult liver and viral diseases; ● • whether favorable findings from clinical trials of Bylvay to date, including findings in our anticipated completed Phase 3 clinical trial in PFIC and findings in indications other than PFIC, will be predictive of results from future clinical trials, including our pivotal trial of Bylvay in biliary atresia and our pivotal trial of Xxxxxx in ALGS; • the outcome and interpretation by regulatory authorities of an ongoing third-party study pooling and analyzing long-term PFIC patient data; • the timing for completion of, or for availability of data from, our pivotal trial of Bylvay in biliary atresia and our pivotal trial of Bylvay in ALGS, and the outcomes of such trials; • delays or other challenges in the recruitment of patients for the pivotal trial of Xxxxxx in biliary atresia; • the COVID-19 pandemic, which may negatively impact the conduct of, and the timing of initiation, enrollment, completion and reporting with respect to, our clinical development, regulatory submissions, commencement trials; negatively impact the supply of drug product for our clinical and completion preclinical programs; and/or result in other adverse impacts on our business; • the competitive environment and commercial opportunity for a treatment for PFIC and potentially other orphan pediatric cholestatic liver diseases; • the conduct and results of clinical trials and product approvals; ● the results nonclinical studies and assessments of Bylvay, A3907, A2342 or any of our clinical trialsother product candidates and programs, including the possibility performance of unfavorable clinical trial results third parties engaged to execute them and difficulties or delays in patient enrollment and data analysis; • the medical benefit that results may be derived from Bylvay, A3907, A2342 or any of our clinical trials will differ from results other product candidates; • the extent to which our agreement with EA Pharma for elobixibat generates nondilutive income for us; • the timing and success of submission, acceptance and approval of regulatory filings and any related restrictions, limitations or warnings in past clinical trialsthe label of any approved product candidates; ● actual • whether we are able to effectively commercialize Bylvay in patients with PFIC; • the significant control or anticipated variations influence that EA Pharma has over the commercialization of elobixibat in our operating resultsJapan, and through its sublicensee in Thailand, and the development and commercialization of elobixibat in EA Pharma’s other licensed territories; ● our cash position; ● market conditions in our industry; ● • whether we elect to seek and, if so, our ability to complete required clinical trials of our product candidates and obtain approval from the FDA establish a license or other regulatory agencies partnering transaction with a third party for elobixibat in different jurisdictionsthe United States or Europe; ● the potential impact of the COVID-19 pandemic, including sustained social distancing efforts, on our operations, including our clinical development plans and timelines; ● our ability to maintain or protect the validity of our patents and other intellectual property; ● our ability to retain key personnel; ● our ability to internally develop new inventions and intellectual property; ● interpretations of current laws and the passages of future laws; ● acceptance of our business model by investors; ● • the accuracy of our estimates regarding expenses expenses, costs, revenues, uses of cash and capital requirements; ● • our ability to adequately support growthobtain additional financing on reasonable terms, or at all; ● • our expectations related ability to establish and maintain additional licensing, collaboration or similar arrangements on favorable terms and our ability to attract collaborators with development, regulatory and commercialization expertise; • the use success of proceeds from this offering competing third-party products or product candidates; • our ability to successfully commercialize any approved product candidates, including their rate and prior offerings degree of market acceptance; • our ability to expand and protect our intellectual property estate; • regulatory developments in the United States and other financing activitiescountries; • the effectiveness of our internal control over financial reporting; • the performance of our third-party suppliers, manufacturers and contract research organizations and our ability to obtain alternative sources of raw materials; • our ability to attract and retain key personnel; and ● • our estimates regarding expenses, future revenue, capital requirements and ability to satisfy our capital needs. Forward-looking statements may also concern our expectations comply with regulatory requirements relating to our subsidiariesbusiness, and the costs of compliance with those requirements, including those on data privacy and security. We caution you that These and other risks and uncertainties are described in greater detail under the foregoing list may not contain all of the forward-looking statements made caption “Risk Factors” in this prospectus supplement prospectus, as updated and supplemented by the accompanying prospectuses discussion of risks and uncertainties under “Risk Factors” contained in any supplements to this prospectus, or the information incorporated herein and therein. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus supplement, the accompanying prospectuses and the information incorporated herein and therein, particularly in sections entitled “Business,” “Risk Factors,” that could cause actual “Cautionary Note Regarding Forward-Looking Statements” or “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our most recent annual report on Form 10-K, as revised or supplemented by our subsequent quarterly reports on Form 10-Q or our subsequent current reports on Form 8-K, as well as any amendments thereto, as filed with the SEC and which are incorporated herein by reference. As a result of the risks and uncertainties, the results or events indicated by the forward- looking statements contained in this prospectus or in any document incorporated herein by reference may not occur. Investors are cautioned not to differ materially from the place undue reliance on any forward-looking statements statement. Each forward- looking statement represents our views only as of the date of this prospectus or the date of the document incorporated by reference in this prospectus and should not be relied upon as representing our views as of any subsequent date. We anticipate that we makesubsequent events and developments may cause our views to change. We expressly disclaim any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. You should read this prospectus supplement, the accompanying prospectuses, the documents that we incorporate by reference into this prospectus supplement and the accompanying prospectuses, including our Annual Report on Form 10-K for the year ended December 31, 2019, and the documents that we have filed as exhibits to our filings with the SEC completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any All subsequent forward-looking statements, whether as a result of new information, future events statements attributable to us or otherwise, except as required to any person acting on our behalf are expressly qualified in their entirety by lawthe cautionary statements contained or referred to in this section.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement contains “forward-looking statements” that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this prospectus supplement, the accompanying prospectuses including statements regarding our future results of operations and the information incorporated herein financial position, strategy and therein by reference contain plans, and our expectations for future operations, are forward-looking statements within the meaning of Section 27A of the federal securities lawsSecurities Act of 1933, which statements involve substantial risks as amended (the Securities Act), and uncertainties. All statementsSection 21E of the Securities Exchange Act of 1934, other than statements of historical facts, included or incorporated by reference in this prospectus supplement and as amended (the accompanying prospectuses regarding our strategy, future events, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statementsExchange Act). The words “anticipatebelieve,” “believemay,” “will,” “estimate,” “expectcontinue,” “anticipate,” “design,” “intend,” “mayexpect,” “could,” “plan,” “potential,” “predict,” “projectseek,” “should,” “would” or the negative version of these words and similar expressions are intended to identify forward-looking statements, although not all . We have based these forward-looking statements contain these identifying wordson our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, strategy, short- and long-term business operations and objectives, and financial needs. These forward-looking statements includeare subject to a number of risks, uncertainties, assumptions and other important factors, including, among other things, statements aboutothers: : ● our lack • the timing of operating history and history of operating losses; ● our anticipated timing for clinical development, regulatory submissionsenrollment, commencement and completion of clinical trials and product approvals; ● the results of our clinical trials, including ; • the possibility timing and success of unfavorable clinical trial results or that results from our preclinical studies and clinical trials will differ from results in past clinical trialsconducted by us and our development partners; ● actual or anticipated variations in our operating results; ● our cash position; ● market conditions in our industry; ● our • the ability to complete required clinical trials obtain and maintain regulatory approval of our product candidates, and the labeling for any approved products; • the scope, progress, expansion, and costs of developing and commercializing our product candidates; • the size and growth of the potential markets and pricing for our product candidates and obtain approval from the FDA ability to serve those markets; • our expectations regarding our expenses and revenue, the sufficiency or other regulatory agencies in different jurisdictionsuse of our cash resources and needs for additional financing; ● • the potential impact rate and degree of the COVID-19 pandemic, including sustained social distancing efforts, on market acceptance of any of our operations, including product candidates; • our clinical development plans and timelinesexpectations regarding competition; ● • our anticipated growth strategies; • our ability to maintain attract or protect the validity of our patents and other intellectual property; ● our ability to retain key personnel; ● • our ability to internally develop new inventions establish and intellectual propertymaintain development partnerships; ● interpretations of current laws • our expectations regarding federal, state and the passages of future laws; ● acceptance of our business model by investors; ● the accuracy of our estimates regarding expenses and capital foreign regulatory requirements; ● • regulatory developments in the United States and foreign countries; • our ability to adequately support growth; ● obtain and maintain intellectual property protection for our expectations related to the use of proceeds from this offering and prior offerings and other financing activitiesproduct candidates; and ● • the anticipated trends and challenges in our estimates regarding expenses, future revenue, capital requirements business and ability to satisfy our capital needsthe market in which we operate. Forward-looking statements may also concern our expectations relating to our subsidiaries. We caution you that the foregoing list may not contain all of the All written and verbal forward-looking statements made attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this prospectus supplement and the accompanying prospectuses or the information incorporated herein and thereinsection. We may caution investors not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance to rely too heavily on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we makemake or that are made on our behalf. We have included important factors in the cautionary statements included in this prospectus supplement, the accompanying prospectuses and the information incorporated herein and therein, particularly in “Risk Factors,” that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. You should read this prospectus supplement, the accompanying prospectuses, the documents that we incorporate by reference into this prospectus supplement and the accompanying prospectuses, including our Annual Report on Form 10-K for the year ended December 31, 2019undertake no obligation, and the documents that we have filed as exhibits to our filings with the SEC completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume specifically decline any obligation obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. This prospectus supplement and accompanying prospectus include statistical and other industry and market data that we obtained from industry publications and research, except surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe these industry publications and third-party research, surveys and studies are reliable, we have not independently verified such data. In addition, you should refer to the section of this prospectus supplement entitled “Risk Factors” as required well as the documents we have incorporated by lawreference for a discussion of other important factors that may cause our actual results to differ materially from those expressed or implied by our forward- looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this prospectus supplement will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, including the accompanying prospectuses and the information documents incorporated herein and therein by reference contain herein, contains forward-looking statements within the meaning of the federal United States Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of applicable Canadian securities lawslaw. 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, which results of operations, performance and business prospects and opportunities. Such forward-looking statements involve substantial risks reflect our current beliefs and uncertaintiesare based on information currently available to us. All statementsIn 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 than statements of similar expressions concerning matters that are not historical facts. The forward-looking statements in this prospectus supplement and, included or 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 supplement and in the accompanying prospectuses regarding documents incorporated by reference reflect our strategy, 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 operationsresults, future financial positionperformance, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would” and similar expressions are intended to identify or achievements that may be expressed or implied by such forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements includeincluding, among other things, statements aboutothers: : ● • our lack of operating history product revenues and net losses and a history of operating losses; ● • our anticipated timing for clinical early stage of development, regulatory submissions, commencement particularly the inherent risks and completion of clinical trials and product approvals; ● the results of our clinical trials, including the possibility of unfavorable clinical trial results or that results from our clinical trials will differ from results in past clinical trials; ● actual or anticipated variations in our operating results; ● our cash position; ● market conditions in our industry; ● our ability to complete required clinical trials of our product uncertainties associated with (i) developing new drug candidates and obtain approval from the FDA or other regulatory agencies in different jurisdictions; ● the potential impact of the COVID-19 pandemic, including sustained social distancing efforts, on our operations, including our clinical development plans and timelines; ● our ability to maintain or protect the validity of our patents and other intellectual property; ● our ability to retain key personnel; ● our ability to internally develop new inventions and intellectual property; ● interpretations of current laws and the passages of future laws; ● acceptance of our business model by investors; ● the accuracy of our estimates regarding expenses and capital requirements; ● our ability to adequately support growth; ● our expectations related to the use of proceeds from this offering and prior offerings and other financing activities; and ● our estimates regarding expenses, future revenue, capital requirements and ability to satisfy our capital needs. Forward-looking statements may also concern our expectations relating to our subsidiaries. We caution you that the foregoing list may not contain all of the forward-looking statements made in this prospectus supplement and the accompanying prospectuses or the information incorporated herein and therein. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus supplement, the accompanying prospectuses and the information incorporated herein and therein, particularly in “Risk Factorsgenerally,” that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. You should read this prospectus supplement, the accompanying prospectuses, the documents that we incorporate by reference into this prospectus supplement and the accompanying prospectuses, including our Annual Report on Form 10-K for the year ended December 31, 2019, and the documents that we have filed as exhibits to our filings with the SEC completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.