Poseida Therapeutics Provides Updates and Financial Results for the Third Quarter of 2024
PSTX 11.07.2024
Strong collaboration momentum with Roche expansion of CAR-T partnership and Astellas nomination of second solid tumor research program target
Cash flow positive for the first nine months of 2024;
Presented positive interim Phase 1 results for RMAT-designated P-BCMA-ALLO1 with 91% overall response rate and differentiated safety profile in heavily pretreated relapsed/refractory BCMA-exposed and BCMA-naïve multiple myeloma patients
Introduced P-BCMACD19-ALLO1 as wholly-owned program with compelling biologic rationale for autoimmune disease and hematological malignancies
On track to deliver further updates across allogeneic CAR-T pipeline before year-end 2024, including presentations at the 66th
"Poseida continues to make excellent progress across all of our key initiatives, highlighted by compelling data presentations from our pipeline of innovative, non-viral allogeneic cell therapy and genetic medicine programs, the expansion and advancement of our collaborations with Roche and Astellas, and our science-backed strategy to apply our platform to the large and growing opportunity for CAR-T in autoimmune diseases," said
Recent Accomplishments
Expanded strategic global collaboration with Roche,including ongoing pipeline progress and the nomination of a new dual CAR-T development candidate.
- The new candidate is an allogeneic, dual CAR-T therapy targeting known antigens expressed in hematologic malignancies,including multiple myeloma. Poseida and Roche now have three programs under their collaboration, including P-BCMA-ALLO1, an allogeneic CAR-T therapy in Phase 1/1b development for multiple myeloma, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T candidate in Phase 1 development for B-cell malignancies. Roche has the option to nominate additional development candidates in the future.
- P-BCMA-ALLO1 continues to be positioned as a leading clinical-stage allogeneic CAR-T therapy with a compelling and differentiated profile:interim Phase 1 data presented at the
International Myeloma Society (IMS) annual meeting in September showed a 91% overall response rate (ORR) in an optimized lymphodepletion arm, including a 100% ORR in B-cell maturation antigen (BCMA)-naïve patients, and an 86% ORR in those who had received at least one prior BCMA- and/or G protein-coupled receptor class C group 5 member D (GPRC5D)-targeting treatment modality, along with differentiated safety results with no dose-limiting toxicities, low rates of cytokine release syndrome (CRS) and immune effector cell neurotoxicity syndrome (ICANS) all Grade 2 or less and no graft vs. host disease or Parkinsonism. No anti-myeloma bridging therapy or prophylaxis with steroids or tocilizumab, no invasive apheresis or manufacturing wait with average time from treatment decision to clinical response of only 3.5 weeks1(median time to response of 16 days post initial P-BCMA-ALLO1 therapy). The patients in this study had more advanced disease than the myeloma patients studied in clinical trials of approved autologous CAR-T therapies2, and in the intent-to-treat population, 100% of patients were infused with P-BCMA-ALLO1. - Poseida's conference call to discuss IMS data featured afireside chatwith leading myeloma expertsthat highlighted key aspects of the data and provided context on current treatment approaches. The experts highlighted that off-the-shelf availability allows patients to start therapy fast, without need for bridging therapy commonly required by autologous CAR-T, and in some cases, offers a solution for patients who are ineligible for autologous treatments; rapid clinical responses; attractive safety profile; ability to treat patients on an outpatient basis; and ability to treat BCMA-exposed patients as key benefits observed in the trial.
- P-BCMA-ALLO1 development continues,with ongoing patient enrollment in the recently initiated Phase 1/1b trial that is using the same lymphodepletion regimen as the optimized lymphodepletion arm described above, including two different cell doses. During the third quarter, P-BCMA-ALLO1 was granted Regenerative Medicine Advanced Therapy (RMAT) designation from the
U.S. Food and Drug Administration (FDA) to treat relapsed/refractory multiple myeloma after three or more prior lines of therapies including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. - Poseida has secured
$80 million from Roche collaboration milestones to-date in 2024,including a milestone payment received in the third quarter related to the initiation of the P-BCMA-ALLO1 Phase 1b clinical trial, and an additional payment for the nomination of the new development candidate in October.
Progressed the strategic research collaboration and license agreement with Astellas' wholly owned subsidiary Xyphos Bioscienceswith 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-ALLO1as 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 TSCMapproach and other features unique to the Company's CAR-T platform, such as its proprietary safety switch.
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1Based on interim data from Phase 1 P-BCMA-ALLO1 clinical trial announced in |
2No head-to-head trial has been conducted evaluating P-BCMA-ALLO1 against other products included herein. Cross-trial data interpretation should be considered with caution as it is limited by differences in study population, study design, and other factors. |
Strengthened Poseida's innovation profile and emerging leadership in allogeneic CAR-Twith new data at the
- 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 TSCM-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 (TSCM) and central memory T cells (TCM) 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
In addition, Poseida had a successful INTERACT meeting with the
Other Operational Updates and Upcoming Events
Manufacturing UpdatesThe 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 DayPoseida will host a cell therapy-focused R&D Day on
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 ofwww.poseida.com. A replay of the webcast will be available for approximately 90 days following the presentation.
Financial Results for the Third Quarter 2024
RevenuesRevenues were
Research and Development ExpensesResearch and development expenses were
Research and development expenses were
General and Administrative ExpensesGeneral and administrative expenses were
Net Income (Loss)Net income was
Cash PositionAs of
About
Forward-Looking StatementsStatements 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
Three Months Ended | Nine Months Ended | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Revenues: | ||||||||||||||||
Collaboration revenue | $ | 71,748 | $ | 9,352 | $ | 125,863 | $ | 39,708 | ||||||||
Total revenue | 71,748 | 9,352 | 125,863 | 39,708 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 41,914 | 37,482 | 130,382 | 114,727 | ||||||||||||
General and administrative | 10,092 | 8,092 | 32,072 | 28,576 | ||||||||||||
Total operating expenses | 52,006 | 45,574 | 162,454 | 143,303 | ||||||||||||
Income (loss) from operations | 19,742 | (36,222) | (36,591) | (103,595) | ||||||||||||
Other income (expense): | ||||||||||||||||
Interest expense | (2,295) | (2,236) | (6,807) | (6,404) | ||||||||||||
Other income, net | 2,831 | 6,787 | 8,031 | 12,025 | ||||||||||||
Net income (loss) before income tax | 20,278 | (31,671) | (35,367) | (97,974) | ||||||||||||
Income tax expense | (43) | (107) | (43) | (107) | ||||||||||||
Net income (loss) | $ | 20,235 | $ | (31,778) | $ | (35,410) | $ | (98,081) | ||||||||
Net income (loss) per share, basic and diluted | $ | 0.21 | $ | (0.35) | $ | (0.37) | $ | (1.11) | ||||||||
Weighted-average number of shares outstanding,basic | 97,160,467 | 91,898,347 | 96,716,649 | 88,321,943 | ||||||||||||
Weighted-average number of shares outstanding,diluted | 98,219,947 | 91,898,347 | 96,716,649 | 88,321,943 | ||||||||||||
SELECTED BALANCE SHEET DATA | ||||||||
2024 | 2023 | |||||||
(Unaudited) | ||||||||
Cash, cash equivalents and short-term investments | $ | 230,852 | $ | 212,202 | ||||
Total assets | 293,577 | 273,885 | ||||||
Total liabilities | 206,366 | 170,184 | ||||||
Total stockholders' equity | 87,211 | 103,701 | ||||||
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SOURCE
Poseida Investor and Media Relations: Alex Chapman, Senior Vice President, IR & Corporate Communications, IR@poseida.com; Sarah Thailing, Senior Director, IR & Corporate Communications, PR@poseida.com