Poseida Therapeutics Provides Updates and Financial Results for the Third Quarter of 2022
Entered into a strategic collaboration with Roche to develop allogeneic CAR-T cell therapies for hematological indications; received
Roche transaction and public offering, with net proceeds of
"Throughout the quarter we have advanced our wholly-owned and partnered portfolios of cell and gene therapies for patients with cancer and rare diseases. Despite macro-economic and market challenges facing our industry, we continue to focus on executing on our top priorities," said
Program Updates
CAR-T Programs
In cell therapy, the Company is focused on two allogeneic CAR-T programs progressing in Phase 1 clinical trials:
MUC1-C Program
P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate targeting solid tumors derived from epithelial cells, including breast and ovarian cancers.
BCMA Program
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate targeting relapsed refractory multiple myeloma partnered with Roche.
Autologous PSMA Program
P-PSMA-101 is a solid tumor autologous CAR-T product candidate targeting prostate-specific membrane antigen, or PSMA, being developed to treat patients with metastatic castrate-resistant prostate cancer and salivary gland carcinoma. The Company has been evaluating P-PSMA-101 in a Phase 1 trial, however, has made the strategic decision to stop further enrollment. The clinical data from the Phase 1 trial is still being collected and analyzed and will be utilized to inform other solid tumor allogeneic programs, including the Company's preclinical allogeneic program, P-PSMA-ALLO1.
Gene Therapy Programs
In gene therapy, the Company is advancing multiple gene therapy programs in liver-directed diseases:
OTC Program
P-OTC-101 is an in vivo program for the treatment of urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene. The Company is developing the P-OTC-101 program utilizing a hybrid delivery system and working on an updated timeline for the program.
FVIII Program
The Company is advancing its P-FVIII-101 program partnered with Takeda, which is in development for the in vivo treatment of Hemophilia A. P-FVIII-101 utilizes piggyBac gene modification delivered via lipid nanoparticle that has demonstrated stable and sustained Factor VIII expression in animal models. The Company plans to present preclinical data from this program at the 64th
Financial Results for the Third Quarter 2022
Revenues
Revenues were
Research and Development Expenses
Research and development expenses were
For the nine months ended September 30, 2022, research and development expenses were
General and Administrative Expenses
General and administrative expenses for the three months ended
Net Income (Loss)
Net income was $70.4 million and net loss was
Financing and Cash Position
In
In the third quarter, the Company announced the Roche collaboration, which included a
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, expected timing and plans with respect to clinical trials, including timing of clinical data updates; statements regarding potential fees, milestone and other payments
Selected Financial Data (Unaudited) (In thousands, except share and per share amounts) |
||||||||||||||||
STATEMENTS OF OPERATIONS |
||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Revenues: |
||||||||||||||||
Collaboration revenue |
$ |
116,306 |
$ |
— |
$ |
120,441 |
$ |
— |
||||||||
Total revenue |
116,306 |
— |
120,441 |
— |
||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
35,137 |
32,524 |
118,995 |
97,627 |
||||||||||||
General and administrative |
9,389 |
9,066 |
28,171 |
26,306 |
||||||||||||
Total operating expenses |
44,526 |
41,590 |
147,166 |
123,933 |
||||||||||||
Income (loss) from operations |
71,780 |
(41,590) |
(26,725) |
(123,933) |
||||||||||||
Other income (expense): |
||||||||||||||||
Interest expense |
(1,775) |
(837) |
(4,395) |
(2,518) |
||||||||||||
Other income, net |
656 |
3 |
688 |
8 |
||||||||||||
Net income (loss) before income tax |
70,661 |
(42,424) |
(30,432) |
(126,443) |
||||||||||||
Income tax expense |
(252) |
— |
(252) |
— |
||||||||||||
Net income (loss) |
$ |
70,409 |
$ |
(42,424) |
$ |
(30,684) |
$ |
(126,443) |
||||||||
Net income (loss) per share, basic |
$ |
0.92 |
$ |
(0.68) |
$ |
(0.46) |
$ |
(2.03) |
||||||||
Net income (loss) per share, diluted |
$ |
0.92 |
$ |
(0.68) |
$ |
(0.46) |
$ |
(2.03) |
||||||||
Weighted-average number of shares outstanding, |
76,287,421 |
62,298,243 |
67,235,865 |
62,144,595 |
||||||||||||
Weighted-average number of shares outstanding, |
76,688,382 |
62,298,243 |
67,235,865 |
62,144,595 |
||||||||||||
SELECTED BALANCE SHEET DATA |
||||||||||||||||
2022 |
2021 |
|||||||||||||||
Cash, cash equivalents and short-term investments |
$ |
278,985 |
$ |
206,325 |
||||||||||||
Total assets |
380,481 |
269,309 |
||||||||||||||
Total liabilities |
164,168 |
113,098 |
||||||||||||||
Total stockholders' equity |
216,313 |
156,211 |
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SOURCE
Investor Contact: Alex Lobo, Stern Investor Relations, IR@poseida.com or Media Contact: Sarah Thailing, Senior Director, Corporate Communications and IR, Poseida Therapeutics, Inc., PR@poseida.com