On August 20, 2020 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary gene engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported an operational update and financial results for the quarter ended June 30, 2020 (Press release, Poseida Therapeutics, AUG 20, 2020, View Source [SID1234563902]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The first half of 2020 marked an important milestone in the growth of Poseida as we raised capital through a Series D preferred stock financing and prepared for our initial public offering," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida. "During our transition to a publicly traded company, we have maintained focus on research innovation and advancement of our clinical programs."
Operational Updates
Series D Financing and Initial Public Offering
In the second quarter, the Company raised net proceeds of $104.1 million in a Series D preferred stock financing led by funds advised by Fidelity Management Research Company, LLC. Following the end of the second quarter, the Company completed an initial public offering (IPO), raising net proceeds of $204.8 million. The capital raised in the Series D financing and IPO put the Company in a strong financial position to advance its clinical trials and pre-clinical studies and continue research and development in the Company’s cell and gene therapy programs.
Completion of Internal GMP Pilot Plant
Construction on the Company’s GMP pilot manufacturing facility adjacent to its San Diego headquarters was completed on schedule. The facility will be used to develop and manufacture preclinical materials and clinical supplies for certain of the Company’s Phase 1 and Phase 2 trials, increasing the Company’s capabilities and flexibility.
Initial Data Presentation from Expanded Phase 1 P-BCMA-101 Clinical Trial
The Company will provide an initial presentation of certain manufacturing improvements and related clinical data for the expanded Phase 1 P-BCMA-101 clinical trial for patients with multiple myeloma with a late breaking abstract by CEO, Eric Ostertag, to be presented at the CAR-TCR Digital Week virtual meeting on September 16, 2020.
Program Updates
P-BCMA-101
The Company’s most advanced product candidate, P-BCMA-101, is an autologous CAR-T therapy which is currently enrolling in an expanded Phase 1 clinical trial for the treatment of patients with relapsed/refractory multiple myeloma to inform the potentially registrational Phase 2 clinical trial.
P-PSMA-101
The Company’s second product candidate, P-PSMA-101, is a solid tumor autologous CAR-T product candidate being developed to treat patients with metastatic castrate resistant prostate cancer and started enrollment in May of 2020. On August 17, 2020 the Company announced that the clinical trial for P-PSMA-101 in metastatic castrate resistant prostate cancer was placed on clinical hold by the FDA following a patient death. The Company’s assessment of the event and evaluation of next steps is ongoing, including working with the FDA toward the objective of resuming the clinical trial.
P-BCMA-ALLO1
The Company’s first allogeneic CAR-T product candidate, P-BCMA-ALLO1 is in development for the treatment of relapsed/refractory multiple myeloma and is designed to be fully allogeneic, with genetic edits to eliminate or reduce both host-vs-graft and graft-vs-host alloreactivity. The program is proceeding with an expected IND filing in late 2020 or early 2021.
P-MUC1C-ALLO1
This allogeneic CAR-T product candidate is in preclinical development for solid tumor indications with the potential to treat a wide range of solid tumors. The program is proceeding with an expected IND filing and initiation of a Phase 1 clinical trial in 2021.
P-OTC-101 Gene Therapy Program
P-OTC-101 is the Company’s first liver-directed gene therapy program for in vivo treatment of urea cycle disease caused by congenital mutations in the OTC gene with a high unmet medical need. The program is proceeding with an expected IND submission in late 2021 or early 2022.
Financial Results
Research and Development Expenses
Research and development expenses were $25.2 million for the three months ended June 30, 2020, compared to $16.9 million for the same period in 2019. For the six months ended June 30, 2020, research and development expenses were $48.6 million, compared to $25.5 million for the same period in 2019. The increase in both periods was primarily due to increased headcount, external costs related to preclinical programs and clinical stage programs, including the ongoing P-BCMA-101 and P-PSMA-101 clinical trials.
General and Administrative Expenses
General and administrative expenses were $4.2 million for the three months ended June 30, 2020, compared to $4.0 million for the same period in 2019, with the increase primarily due to increased headcount. General and administrative expenses were $9.1 million for the six months ended June 30, 2020, compared to $10.4 million for the same period in 2019. The decrease was primarily due to a decrease in facility expense related to lease termination costs.
Net Losses
Net losses were $30.4 million and $59.2 million for the three and six months ended June 30, 2020, respectively, and $28.6 million and $42.0 million for the three and six months ended June 30, 2019, respectively.
Cash Position
As of June 30, 2020, we had cash, cash equivalents and short-term investments of $167.1 million. Net proceeds from the Company’s IPO, which closed in July 2020, were $204.8 million.