06/17/2026 | Press release | Distributed by Public on 06/17/2026 05:26
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ABOUT THIS PROSPECTUS
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ii
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PROSPECTUS SUMMARY
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1
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THE OFFERING
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3
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RISK FACTORS
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5
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FORWARD-LOOKING STATEMENTS
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6
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USE OF PROCEEDS
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8
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THE SELLING STOCKHOLDERS
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9
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PLAN OF DISTRIBUTION
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11
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LEGAL MATTERS
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14
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EXPERTS
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15
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WHERE YOU CAN FIND MORE INFORMATION
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INFORMATION INCORPORATED BY REFERENCE
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21,154,753 shares of Common Stock issuable upon the exercise of warrants outstanding as of May 31, 2026, with a weighted-average exercise price of $1.33 per share;
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16,009,928 shares of Common Stock issuable upon the exercise of pre-funded warrants outstanding as of May 31, 2026, with a weighted-average exercise price of $0.0001 per share;
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7,889,109 shares of Common Stock issuable upon the exercise of stock options outstanding as of May 31, 2026, under our 2018 Equity Incentive Plan, 2020 Equity Incentive Plan and 2021 Inducement Plan, with a weighted-average exercise price of $2.41 per share;
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793,503 shares of Common Stock reserved for future issuance under our 2020 Equity Incentive Plan and 2021 Inducement Plan outstanding as of May 31, 2026;
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4,297,924 unvested restricted stock awards as of May 31, 2026; and
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any shares issuable upon the conversion of Notes issued pursuant to the Note Purchase Agreement.
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our gene therapy product candidates are based on a novel technology that is difficult to develop and manufacture, which may result in delays and difficulties in obtaining regulatory approval;
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our planned clinical trials may face substantial delays, result in failure, or provide inconclusive or adverse results that may not satisfy FDA requirements to further develop our therapeutic products;
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delays or difficulties associated with patient enrollment in clinical trials may affect our ability to conduct and complete those clinical trials and obtain necessary regulatory approvals;
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changes in regulatory requirements could result in increased costs or delays in development timelines;
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we depend heavily on the success of our product pipeline; if we fail to find strategic partners or fail to adequately develop or commercialize our pipeline products, our business will be materially harmed;
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others may discover, develop, or commercialize products similar to those in our pipeline before or more successfully than we do or develop generic variants of our products even while our product patents remain active, thereby reducing our market share and potential revenue from product sales;
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we do not currently have any sales or marketing infrastructure in place and we have limited drug research and discovery capabilities;
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the future commercial success of our products could significantly depend upon several uncertain factors, including third-party reimbursement practices and the existence of competitors with similar products;
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product liability lawsuits against us or our suppliers or manufacturers could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop;
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failure to comply with health and safety laws and regulations could lead to material fines;
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we have not generated significant revenue from sales of any products and expect to incur losses for the foreseeable future;
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our future viability is difficult to assess due to our short operating history and our future need for substantial additional capital, access to which could be limited by any adverse developments that affect the financial markets;
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raising additional capital may cause our stockholders to be diluted, among other adverse effects;
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instability and operational disruptions at government agencies, such as the FDA, may adversely impact our development and commercialization plans by causing delays and requiring the use of additional, unforeseen resources to obtain regulatory approval for trials or products in our pipeline;
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we operate in a highly regulated industry and face many challenges adapting to sudden changes in legislative reform or the regulatory environment, including due to government shutdowns and disruptions at government agencies, which cause delays, require the use of additional, unforeseen resources, affect our pipeline stability, and could impair our ability to compete in international markets;
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we may not receive regulatory approval to market our developed product candidates within or outside of the U.S.;
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with respect to any of our product candidates that receive marketing approval, we may be subject to substantial penalties if we fail to comply with applicable regulatory requirements;
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our potential relationships with healthcare providers and third-party payors will be subject to certain healthcare laws and regulations, which could expose us to extensive potential liabilities;
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we rely on third parties for material aspects of our business, such as conducting our nonclinical and clinical trials and supplying and manufacturing bulk drug substances, which exposes us to certain risks;
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we may be unsuccessful in entering into or maintaining licensing arrangements or establishing strategic alliances on favorable terms, which could harm our business;
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inadequate patent protection for our product candidates may result in our competitors developing similar or identical products or technology, which would adversely affect our ability to successfully commercialize;
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we may be unable to obtain full protection for our intellectual property rights under U.S. or foreign laws;
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we may become involved in lawsuits for a variety of reasons associated with our intellectual property rights, including alleged infringement suits initiated by third parties;
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we are dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy;
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as we grow, we may not be able to operate internationally or adequately develop and expand our sales, marketing, distribution, and other corporate functions, which could disrupt our operations;
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the market price of our Common Stock is expected to be volatile and if we fail to comply with the continued listing standards of Nasdaq Capital Market (the "Nasdaq"), our Common Stock may be delisted;
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factors out of our control related to our securities, such as securities litigation or actions of activist stockholders, could adversely affect our business and stock price and cause us to incur significant expenses; and
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other risks, uncertainties and factors, including those set forth under "Risk Factors".
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Name of Selling
Stockholders(1)
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Common
Stock
Beneficially
Owned
Before
Offering(2)
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Common
Stock that
May
Be Offered
Pursuant to
Prospectus
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Common Stock
Beneficially
Owned After
Offering(2)
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Number
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Percentage
(%)
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TPC Investments Solutions LP(3)
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659,496
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1,581,371
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0
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*
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TPC Investments Solutions Co-Invest LP(4)
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456,574
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1,097,199
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0
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*
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*
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Less than 1%
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(1)
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To our knowledge, unless otherwise indicated, all persons named in the table above have sole voting and investment power with respect to their shares of Common Stock.
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(2)
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"Beneficial ownership" is a term broadly defined by the SEC in Rule 13d-3 under the Exchange Act, and includes more than the typical form of stock ownership, that is, stock held in the person's name. The term also includes what is referred to as "indirect ownership," meaning ownership of shares as to which a person has or shares investment power. Notwithstanding the foregoing, the beneficial ownership amounts assume the sale of all Common Stock that may be offered pursuant to this prospectus without taking into account certain limitations, including that a holder of Conversion Shares is prohibited from converting Notes into shares of Common Stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 4.9% of the Common Stock outstanding immediately after giving effect to such conversion (or such higher or lower amount as such holder may specify with at least 61 days' written notice to the Company, but which in no event may exceed 19.9% of the Common Stock outstanding immediately after giving effect to such conversion).
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(3)
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Consists of (i) 659,496 Purchased Shares issued pursuant to the Stock Purchase and Conversion Agreement and (ii) 921,875 Conversion Shares issuable upon conversion of the Notes pursuant to the Note Purchase Agreement. TPC Investments Solutions LP is managed by Oberland Capital Management LLC. The address of the foregoing entities is c/o Oberland Capital Management LLC, 1700 Broadway, 41st Floor, New York, NY 10019. The Common Stock held by TPC Investments Solutions LP issuable upon conversion of the Notes is subject to a beneficial ownership limitation of 4.9% (which may be increased up to 19.9% upon at least 61 days' prior written notice to the Company).
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(4)
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Consists of (i) 456,574 Purchased Shares issued pursuant to the Stock Purchase and Conversion Agreement and (ii) 640,625 Conversion Shares issuable upon conversion of the Notes pursuant to the Note Purchase Agreement. TPC Investments Solutions Co-Invest LP is managed by Oberland Capital Management LLC. The address of the foregoing entities is c/o Oberland Capital Management LLC, 1700 Broadway, 41st Floor, New York, NY 10019. The Common Stock held by TPC Investments Solutions Co-Invest LP issuable upon conversion of the Notes is subject to a beneficial ownership limitation of 4.9% (which may be increased up to 19.9% upon at least 61 days' prior written notice to the Company).
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ordinary brokerage transactions and transactions in which a broker-dealer solicits purchasers;
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block trades in which a broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction;
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purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
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an exchange distribution in accordance with the rules of the applicable exchange;
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privately negotiated transactions;
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"at the market" transactions or through market makers or into an existing market for the shares;
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short sales entered into after the effective date of the registration statement of which this prospectus is a part;
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through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise, after the effective date of the registration statement of which this prospectus is a part;
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through the distribution of the shares by any selling stockholder to its partners, members or stockholders;
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through broker-dealers that agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share;
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through one or more underwritten offerings on a firm commitment or best efforts basis;
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a combination of any such methods of sale; and
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any other method permitted pursuant to applicable law.
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Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 12, 2026;
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Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 filed with the SEC on May 12, 2026;
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The information contained in our Definitive Proxy Statement on Schedule 14A, filed with the SEC on March 23, 2026, that is incorporated by reference in the 2025 Annual Report;
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Current Reports on Form 8-K, filed with the SEC on February 19, 2026, April 7, 2026 (excluding Item 7.01 and the related exhibits), April 7, 2026, April 22, 2026 and April 24, 2026; and
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The description of our Common Stock contained in our Registration Statement on Form 8-A, filed with the SEC on June 7, 2019, including any amendments or reports filed for the purpose of updating such description, including Exhibit 4.13 to the Annual Report on Form 10-K for the year ended December 31, 2025.
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