Poseida Therapeutics Reports Operational Update and Financial Results for Third Quarter 2020
"During our first quarter as a publicly traded company, we continued to maintain our focus on research innovation and advancement of our clinical programs, while also building new strategic collaborations," said
Program Updates
P-PSMA-101
P-PSMA-101 is a solid tumor autologous CAR-T product candidate being developed to treat patients with metastatic castrate resistant prostate cancer. The program started enrollment in
P-BCMA-101
P-BCMA-101 is an autologous CAR-T product candidate for the treatment of patients with relapsed/refractory multiple myeloma. The program is currently enrolling in an expanded Phase 1 clinical trial to inform the potentially registrational Phase 2 clinical trial. Phase 1 dose expansion enrollment continues, although at a slower pace than planned due in part to the COVID-19 pandemic. Further, the Company expects to make a Phase 2 dosing decision on P-BCMA-101 by early 2021.
At the CAR-TCR Digital Week meeting on
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 designed to reduce or eliminate both host-vs-graft and graft-vs-host alloreactivity. The program is proceeding toward an IND filing which is expected in the first half 2021.
P-MUC1C-ALLO1
This allogeneic CAR-T product candidate is in preclinical development with the potential to treat a wide range of solid tumors, including breast and ovarian cancers. The program is proceeding with an expected IND filing 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, a condition characterized by high unmet medical need. The Company now expects to submit an IND in 2022 due to pandemic related factors, including longer timelines due to COVID-19 vaccine-related capacity constraints at certain vendors.
Early Stage Development Programs
For programs in early development, including the fully allogeneic Dual CAR programs, P-PSMA-ALLO1 and P-MMUT-101, the Company expects to update specific guidance at a later date, as it gains further clarity on the timelines and any impacts of the COVID-19 pandemic.
Other Operational Updates and Upcoming Events
Collaboration agreement with TScan Therapeutics to explore developing allogeneic T cell receptor therapies for the treatment of COVID-19
In October, the Company and TScan Therapeutics announced a research collaboration and license agreement to explore the use of the Company's fully allogeneic stem cell memory T cell platform in combination with TScan's proprietary TCR platform and findings related to SARS-CoV-2. The collaboration will allow the Company to explore platform and T cell technology utilizing one or more TCRs in allogeneic cell therapy applications.
The Company is participating in a virtual conference that will be made available at
62nd
The Company plans to provide an update on the P-BCMA-101 Phase 1 expansion trial in early December with an oral presentation at the 62nd
Financial Results
Research and Development Expenses
Research and development expenses were
General and Administrative Expenses
General and administrative expenses were
Net Losses
Net losses were $34.4 million and
Cash Position
As of
About
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, the potential benefits of
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STATEMENTS OF OPERATIONS |
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Three Months Ended |
Nine Months Ended |
||||||||||
2020 |
2019 |
2020 |
2019 |
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Operating expenses: |
|||||||||||
Research and development |
$ 27,016 |
$ 15,696 |
$ 75,636 |
$ 41,189 |
|||||||
General and administrative |
6,458 |
4,007 |
15,553 |
14,449 |
|||||||
Increase in contingent consideration |
— |
1,060 |
— |
6,683 |
|||||||
Total operating expenses |
33,474 |
20,763 |
91,189 |
62,321 |
|||||||
Loss from operations |
(33,474) |
(20,763) |
(91,189) |
(62,321) |
|||||||
Other income (expense): |
|||||||||||
Interest expense |
(848) |
(935) |
(2,654) |
(2,633) |
|||||||
Other income (expense), net |
(92) |
744 |
216 |
2,040 |
|||||||
Net loss before income tax |
(34,414) |
(20,954) |
(93,627) |
(62,914) |
|||||||
Income tax benefit |
— |
— |
— |
— |
|||||||
Net loss |
$ (34,414) |
$ (20,954) |
$ (93,627) |
$ (62,914) |
|||||||
Net loss per share attributable to common stockholders, basic and diluted |
$ (0.63) |
$ (1.65) |
$ (3.43) |
$ (5.06) |
|||||||
Weighted-average shares of common stock, basic and diluted |
54,973,788 |
12,665,834 |
27,324,297 |
12,427,367 |
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SELECTED BALANCE SHEET DATA |
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Cash, cash equivalents and short-term investments |
$ 341,457 |
$ 125,318 |
|||||||||
Total assets |
405,171 |
146,996 |
|||||||||
Total liabilities |
109,335 |
74,334 |
|||||||||
Convertible preferred stock |
- |
222,173 |
|||||||||
Total stockholders' equity (deficit) |
295,836 |
(149,511) |
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SOURCE
mgraham@poseida.com