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Progressed the strategic research collaboration and license agreement with Astellas' wholly owned subsidiary Xyphos Biosciences with the formal nomination of the second high potential program target. Both program targets nominated under the collaboration are well-known and validated solid tumor targets.

Accelerating highly differentiated dual targeting allogeneic CAR-T for autoimmune disease with P-BCMACD19-ALLO1 as first pipeline candidate to address this significant market opportunity. P-BCMACD19-ALLO1 is an allogeneic dual CAR-T candidate currently in IND-enabling studies. We believe targeting BCMA and CD19 could provide the potential to enable more complete immune cell depletion than CAR-Ts targeting only one of the antigens, and that targeting BCMA specifically could provide the potential to deplete autoantibodies from plasma cells, which are believed to be a key driver in many autoimmune diseases and not addressed by targeting CD19 alone. Emerging data from an autologous dual CAR-T targeting BCMA and CD19 has thus far substantiated this dual targeting approach. P-BCMACD19-ALLO1 is also positioned to provide the access benefits of an allogeneic product and a potentially attractive safety profile derived from Poseida's non-viral T_SCM approach and other features unique to the Company's CAR-T platform, such as its proprietary safety switch.

Strengthened Poseida's innovation profile and emerging leadership in allogeneic CAR-T with new data at the Society of Hematologic Oncology (SOHO) Twelfth Annual Meeting in September and the Society for Immunotherapy of Cancer (SITC) 39^th Annual Meeting & Pre-Conference Programs in November.

• A new case study demonstrating the reactivation of an autologous Poseida CAR-T therapy with a T-cell engager in a patient with relapsed multiple myeloma was presented at SOHO. The patient attained and remains in stringent complete response over 10 months after CAR-T reactivation. This case highlights the potential of Poseida's T_SCM-based CAR-T therapies to deliver a strong anti-myeloma response with long-term remission and CAR-T cell persistence. The Company believes this is the first time that a T-cell engager has been seen to reactivate a CAR-T therapy.

• New preclinical data highlighting the potential of Poseida's platform to design and manufacture CAR-TCR-T cells that are rich in stem cell memory T cell (T_SCM) and central memory T cells (T_CM) for potential use in solid tumors will be presented at SITC on November 9. In solid tumors, multi-antigens are believed to be necessary for efficacy, and CAR+TCR-T cells can recognize and kill single and double antigen target cells and show the potential to synergize with T-cell engagers. Key highlights from the SITC presentation include:

  • CAR+TCR-T cells were shown to control single and double antigen-positive tumor growth in vivo, with sustained persistence.

  • T-cell engager was used to re-activate and re-direct engrafted CAR+TCR-T cells to control a secondary tumor challenge expressing different antigens echoing the patient case study presented at SOHO and suggesting an approach to address heterogeneous tumors and/or tumors whose composition evolves over time.

Continued to enroll patients in the Phase 1 clinical trial of P-CD19CD20-ALLO1. In light of the competitive environment for therapies targeting CD19 and CD20, Poseida and Roche anticipate providing initial clinical data from the trial in 2025 once a more complete dataset of the program is available.

Genetic Medicines

Demonstrated ongoing leadership in development of non-viral approaches to genetic medicines, supported by data presentation at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Scientific Meeting featuring P-KLKB1-101, a non-viral, liver-directed genetic medicine that uses the Company's Cas-CLOVER™ Site-Specific Gene Editing System. The data showed high-fidelity gene editing at KLKB1 for the targeted correction of hereditary angioedema (HAE), the ability for controlled dose response, favorable tolerability and liver editing approaching the desired therapeutic range. The data reinforce the potential of Cas-CLOVER to be a unique and attractive gene editing tool for a variety of diseases, starting with HAE and KLKB1 editing.

In addition, Poseida had a successful INTERACT meeting with the U.S. FDA for P-FVIII-101 in September 2024. The meeting provided Poseida with early engagement and communication with FDA on the program, in order to support efficient development designed to be aligned with FDA standards. INTERACT meetings focus on innovative and emerging technologies covered by the FDA's Center for Biologics Evaluation and Research (CBER).

Other Operational Updates and Upcoming Events

Manufacturing Updates
The Company continues to advance its platform process and analytical capabilities for allogeneic cell therapy manufacturing. Recent analytical enhancements have enabled more precise evaluation of prospective donors as well as providing improved characterization of drug product attributes.

Cell Therapy R&D Day
Poseida will host a cell therapy-focused R&D Day on November 14, 2024, to highlight progress and further opportunities across its clinical-stage and earlier-stage pipeline of differentiated allogeneic CAR-T therapies in oncology and autoimmune disease.

The virtual event and access to the live webcast will be available through the following registration link: https://wsw.com/webcast/cc/pstx7/1467684. Registration for this virtual event and access to a replay of the live webcast will also be available on the Investors & Media section of www.poseida.com. A replay of the webcast will be available for approximately 90 days following the presentation.

Financial Results for the Third Quarter 2024

Revenues
Revenues were $71.7 million for the three months ended September 30, 2024, and $125.9 million for the nine months ended September 30, 2024, compared to $9.4 million and $39.7 million for the same periods in 2023, respectively. The increases were primarily due to milestone recognition and an increase in reimbursed research and development expenses under the Roche Collaboration Agreement, and revenue recognized from the Astellas Strategic Agreements and Astellas Collaboration Agreement.

Research and Development Expenses 
Research and development expenses were $41.9 million for the three months ended September 30, 2024, compared to $37.5 million for the same period in 2023. The increase was primarily due to an increase in allogeneic clinical stage programs, driven mainly by an increase in overall enrollment of the Company's allogeneic programs, and by an increase in preclinical stage programs and other unallocated expenses.

Research and development expenses were $130.4 million for the nine months ended September 30, 2024, compared to $114.7 million for the same period in 2023. The increase was primarily due to an increase in allogeneic clinical stage programs, driven mainly by an increase in overall enrollment of the Company's allogeneic programs and the initiation of its third allogeneic clinical trial, P-CD19CD20-ALLO1, and by an increase in preclinical stage programs and other unallocated expenses.

General and Administrative Expenses
General and administrative expenses were $10.1 million for the three months ended September 30, 2024, and $32.1 million for the nine months ended September 30, 2024, compared to $8.1 million and $28.6 million for the same periods in 2023, respectively. The increases were primarily due to increased legal and professional fees as a result of higher patent-related and other consulting costs, and higher personnel expenses.

Net Income (Loss) 
Net income was $20.2 million for the three months ended September 30, 2024, and net loss was $35.4 million for the nine months ended September 30, 2024, compared to net loss of $31.8 million and $98.1 million for the three and nine months ended September 30, 2023, respectively.

Cash Position
As of September 30, 2024, the Company's cash, cash equivalents and short-term investments balance was $230.9 million. This includes $115 million in milestone and upfront payments generated in the first nine months of 2024, consisting of a $50 million upfront payment from the Astellas collaboration and $65 million from continued execution in the Company's CAR-T partnership with Roche. The Company expects that its cash, cash equivalents and short-term investments together with these and other remaining near-term milestones and other payments from Roche will be sufficient to fund operations into early 2026. Potential additional anticipated progress and payments under the Roche Collaboration Agreement and/or potential additional business development could further extend the cash runway.

About Poseida Therapeutics, Inc.
Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated allogeneic cell therapies and genetic medicines with the capacity to cure. The Company's pipeline includes investigational allogeneic CAR-T cell therapies for hematologic cancers, autoimmune diseases, and solid tumors, as well as investigational in vivo genetic medicines that address patient populations with high unmet medical need. The Company's approach is based on its proprietary genetic editing platforms, including its non-viral transposon-based DNA delivery system, Cas-CLOVER™ Site-Specific Gene Editing System, Booster Molecule and nanoparticle gene delivery technologies, as well as in-house GMP cell therapy manufacturing. The Company has formed strategic collaborations with Roche and Astellas to unlock the promise of cell therapies for cancer patients. Learn more at www.poseida.com and connect with Poseida on X and LinkedIn.

Forward-Looking Statements 
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, expected plans with respect to clinical trials, including timing of regulatory meetings and submissions and approvals and clinical data updates; potential fees, reimbursements, milestones, royalty payments and other payments that the Company may receive pursuant to its collaboration agreements with Roche and Astellas, including related timing; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities, benefits and opportunities of the Company's technology platforms and product candidates, including the efficacy, safety and tolerability profile of such product candidates or any ability to deliver therapeutic approaches in autoimmune disease; the quote from Dr. Yarema; estimates of the Company's cash balance, cash runway, expenses, capital requirements and any future revenue; the Company's ability to exploit and consummate additional business development opportunities, including with Roche and Astellas, and any anticipated upside potential and impact on the Company's cash balance and cash runway; the Company's ability to attract and/or retain new and existing collaborators with relevant expertise and its expectations regarding the potential benefits to be derived from any such collaborations; and the Company's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the Company's reliance on third parties for various aspects of its business; risks associated with conducting clinical trials; whether any of the Company's product candidates will be shown to be safe and effective; the Company's ability to finance continued operations; competition in the Company's target markets; the Company's ability to protect its intellectual property; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; the fact that the Company will have limited control over the efforts and resources that its collaborators devote to advancing development programs under their respective collaboration agreements; the fact that the Company may not receive the potential fees, reimbursements and payments under the collaboration agreements; the ability of the Company's collaborators to early terminate the collaborations, such that the Company may not fully realize the benefits of the collaborations; and the other risks described in the Company's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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SOURCE Poseida Therapeutics, Inc.