04/03/2026 | Press release | Distributed by Public on 04/03/2026 15:29
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ABOUT THIS PROSPECTUS
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1
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
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2
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PROSPECTUS SUMMARY
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4
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RISK FACTORS
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6
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USE OF PROCEEDS
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PLAN OF DISTRIBUTION
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10
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LEGAL MATTERS
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11
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EXPERTS
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WHERE YOU CAN FIND ADDITIONAL INFORMATION
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INFORMATION WE INCORPORATE BY REFERENCE
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our limited operating history and lack of any products approved for sale;
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our history of significant losses and our expectation of incurring significant losses for the foreseeable future;
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our ability to generate revenue from product sales and achieve or maintain profitability;
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our ability to obtain additional capital, including any resulting dilution to our stockholders, restrictions on our operations or requirements to relinquish rights to our product candidates;
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our dependence upon the success of our chimeric antigen receptor-NK ("CAR NK") cell technology platform and the significant challenges we must overcome to develop, commercialize and manufacture our product candidates;
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our dependence upon the success of our product candidates, and in particular the clinical success of NKX019 and the risks we face that we may fail to develop NKX019 and/or our other product candidates successfully or be unable to obtain regulatory approval for them;
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that clinical data supporting the effectiveness of CD19-targeted cell therapies against autoimmune disease are limited, and CD19-targeted CAR NK cell therapies, such as NKX019, may not provide the same, or any, therapeutic benefit against autoimmune diseases, or be competitive with respect to other CD19-targeted therapies for the treatment of autoimmune disease;
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our ability to enroll and retain patients in clinical trials, which is expensive and time-consuming;
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our ability to obtain and maintain regulatory approval of our product candidates for any of the indications for which we plan to develop them, and any related restrictions, limitations and/or warnings in the label of an approved product;
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our ability to achieve our milestones for development of our product candidates, including the timely conduct of our clinical trials and the availability of clinical data from those trials;
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any changes that may occur in interim, preliminary or "topline" data from our clinical trials;
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that we may be required to halt or delay further clinical development if any of our product candidates, or any competing product candidates, demonstrate relevant, serious adverse events;
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our ability to establish additional collaborations with third parties on commercially reasonable terms, or at all;
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our ability to compete effectively with academic institutions and other biopharmaceutical companies that develop similar or alternatives to cellular immunotherapy product candidates;
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our ability to produce and internally manufacture our product candidates, including our reliance on third parties to manufacture certain of our product candidates;
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our reliance on a sole supplier for certain steps of our manufacturing process;
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our ability to commission and receive regulatory approvals for our manufacturing facilities, which could result in delays to our development plans and limit our ability to develop our product candidates;
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our ability to establish optimal donor and manufacturing parameters for our product candidates;
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our ability to maintain our license agreement with National University of Singapore and St. Jude Children's Research Hospital with respect to certain rights to our product candidates;
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our ability to obtain and maintain patent protection for our products and our ability to operate our business without infringing on the intellectual property rights of others;
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our ability to develop and maintain sales and marketing capabilities if any of our product candidates are approved for marketing and commercialization;
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any regulatory limitations on our product candidates following approval, including NKX019, if and when such approval is granted;
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volatility of the market price of our common stock;
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the concentration of ownership of our shares of common stock among our existing executive officers, directors and principal stockholders, which may prevent new investors from influencing significant corporate decisions;
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disruption to our product development program as a result of computer system interruptions or security breaches of our information systems; and
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other risks and uncertainties discussed in "Risk Factors" in this prospectus supplement and Part I, Item 1A, Risk Factors in our most recent Annual Report on Form 10-K filed with the SEC, as such risk factors may be amended, supplemented or superseded from time to time by our subsequent periodic reports we file with the SEC, including our Quarterly Reports on Form 10-Q, and in any prospectus supplement.
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11,386,162 shares of common stock issuable upon the exercise of outstanding stock options and vesting of restricted stock units under our 2020 Performance Incentive Plan (the "2020 Plan") and our 2015 Equity Incentive Plan;
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3,914,097 shares of our common stock reserved for future issuance of equity award grants under our 2020 Plan;
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2,173,680 shares of common stock reserved for future issuance under our 2020 Employee Stock Purchase Plan; and
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3,000,031 shares of our common stock issuable upon the exercise of our existing pre-funded warrants.
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our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on March 25, 2026;
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the portions of our definitive proxy statement on Schedule 14A that are incorporated by reference into Part III of our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on April 21, 2025; and
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the description of our common stock, par value $0.0001 per share, contained in Exhibit 4.3 to our Annual Report on Form 10-K for the year ended December 31, 2025 (filed with the SEC on March 25, 2026), which updated the description thereof contained in our Registration Statement on Form 8-A, filed with the SEC on July 2, 2020 (File No. 001-39370), and any amendments or reports filed for the purpose of updating such description.
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