Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical organization, has provided updates and financial results for the second quarter ending June 30, 2024. The company is focused on advancing allogeneic cell therapies and genetic medicines for cancer and rare diseases.
In the first half of 2024, Poseida has made significant advancements across its portfolio. Key highlights include progress in its CAR-T programs and genetic medicines pipeline. The company anticipates several clinical data readouts by the end of the year, particularly in their BCMA, CD19CD20, and MUC1-C programs. Strategic partnerships with Roche and Astellas have been instrumental, providing financial and operational support.
Cell Therapy Developments
Poseida secured $45 million from its partnership with Roche, with more milestones expected in the latter half of 2024. The initiation of the Phase 1b portion of the P-BCMA-ALLO1 clinical trial is planned, incorporating process improvements and feedback from clinicians. Poseida retains operational responsibility for this trial, with Roche funding the expanded Phase 1/1b trials.
The collaboration with Astellas' subsidiary, Xyphos Biosciences, also progressed, marked by a $50 million upfront payment. This collaboration focuses on high-potential allogeneic solid tumor CAR-T targets.
Genetic Medicine Progress
Poseida showcased its non-viral genetic medicine approaches at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting. Highlights included:
- P-KLKB1-101 for hereditary angioedema (HAE) demonstrated promising preclinical data with the Cas-CLOVER nuclease formulation, showing high fidelity and efficiency in editing within a target range.
- P-FVIII-101 for Hemophilia A indicated sustained FVIII expression in rodents for over 13 months and showed reduced immunogenicity. The FDA granted an INTERACT meeting for this program, aimed at supporting its development aligned with regulatory standards.
Upcoming Milestones
Several data updates are anticipated in the latter half of 2024:
- P-BCMA-ALLO1 in relapsed/refractory multiple myeloma (RRMM) will present new data at the International Myeloma Society Meeting in September.
- P-MUC1C-ALLO1 and P-CD19CD20-ALLO1 are expected to provide clinical updates for solid tumors and B-cell malignancies, respectively.
- Updates for P-KLKB1-101 (HAE) and P-FVIII-101 (Hemophilia A) are also expected in the fourth quarter of 2024.
Operational and Financial Highlights
Poseida continues to enhance its manufacturing capabilities for allogeneic cell therapies, with recent improvements in analytical methods. The company plans to host an R&D day focusing on cell therapy in November 2024.
Poseida is exploring new opportunities in CAR-T therapies beyond oncology, particularly in autoimmune diseases. They aim to leverage their existing platforms for new therapeutic approaches. Updates on this strategy are expected later in the year.
Financial Results
For the second quarter, revenues reached $26.0 million, an increase from the previous year's $20.0 million, primarily due to milestone recognition and reimbursed research and development expenses from the Roche collaboration. For the six months ending June 30, 2024, revenues were $54.1 million, also up from the previous year's $30.4 million.
Research and development expenses rose to $45.5 million for the quarter, driven by increased enrollment in allogeneic programs and the initiation of a third clinical trial, P-CD19CD20-ALLO1. General and administrative expenses also increased to $12.2 million, largely due to higher personnel and legal expenses.
The company reported a net loss of $31.4 million for the quarter and $55.6 million for the first half of the year. As of June 30, 2024, Poseida's cash, cash equivalents, and short-term investments totaled $237.8 million. This includes $95 million from milestone and upfront payments. These funds are expected to support operations into the second half of 2025, with potential additional progress and milestone payments extending the financial runway further.
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