Poseida Therapeutics Provides Updates and Financial Results for the Second Quarter of 2024
Continued Roche CAR-T partnership progress with agreement for
Strong Astellas research collaboration momentum with nomination of first allogeneic solid tumor CAR-T program target
On track to deliver meaningful clinical updates across allogeneic CAR-T pipeline in the second half of 2024 with first data readout anticipated at
Continued progress on non-viral genetic medicines pipeline, including FDA granting of INTERACT meeting for P-FVIII-101
"
Recent Accomplishments
Advanced Roche partnership, securing
Progressed the strategic research collaboration and license agreement with Astellas' wholly owned subsidiary Xyphos Biosciences with the formal nomination of the first high-potential program target.
Genetic Medicine
Demonstrated ongoing leadership in development of non-viral approach to genetic medicines, supported by multiple data presentations at the
ASGCT data highlights:
- In P-KLKB1-101 for hereditary angioedema (HAE), interim preclinical data in a non-human-primate (NHP) model showed that the Cas-CLOVER nuclease formulation was well tolerated and yielded dose-dependent levels of editing in early read-out data.
- Studies in human cells and rodent models show high fidelity and high efficiency KLKB1 editing within a target range for correction of HAE. P-KLKB1-101 demonstrated a highly controlled dose-dependent reduction in kallikrein protein with human hepatocyte studies revealing minimal off-target editing. This was consistent with findings that Cas-CLOVER displays approximately 20-fold higher fidelity than Cas9, across multiple cell types and targets.
- In P-FVIII-101 for Hemophilia A, preclinical rodent data support advancing to NHP studies based on sustained FVIII expression at physiologically desired levels over 13 months from a single dose, along with data supporting significantly reduced immunogenicity (relative to a conventional lipid nanoparticle (LNP)) and the ability to fine tune FVIII expression levels via repeat dosing and/or
Poseida's proprietary modulator switch. - Additional data describing the Company's advancements in its proprietary LNP technology, intracellular targeting agents and nuclease fidelity.
In addition, the FDA recently granted an INTERACT meeting for P-FVIII-101 in
Upcoming Milestones
-
P-BCMA-ALLO1 in relapsed/refractory multiple myeloma (RRMM): new data anticipated for presentation at the
International Myeloma Society 21st Annual Meeting, being heldSeptember 25-28, 2024 , inRio de Janeiro . Additional clinical updates are planned for the second half of 2024, subject to coordination with Roche. - P-MUC1C-ALLO1 in solid tumors: clinical update planned for the second half of 2024.
- P-CD19CD20-ALLO1 in B-cell malignancies: interim data update anticipated in the second half of 2024, subject to coordination with Roche.
- P-KLKB1-101 for HAE and P-FVIII-101 for Hemophilia A: data updates anticipated in the fourth quarter 2024.
Other Operational Updates and Upcoming Events
Manufacturing Updates
The 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 superior characterization of drug product attributes.
Cell Therapy R&D Day
Evaluating Opportunities in CAR-T Beyond Oncology
The Company believes its TSCM-rich CAR-T platform and associated proprietary technologies have strong potential to deliver new therapeutic approaches in autoimmune disease. The Company remains well positioned to potentially advance an allogeneic CAR-T strategy for autoimmune disease and is actively working to identify the optimal opportunity to leverage its existing programs and/or platforms in areas where it is best positioned to lead. The Company will provide an update later this year.
Financial Results for the Second Quarter 2024
Revenues
Revenues were
Revenues were
Research and Development Expenses
Research and development expenses were
General and Administrative Expenses
General and administrative expenses were
General and administrative expenses were
Net Loss
Net loss was
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, 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 and benefits 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
Selected Financial Data (In thousands, except share and per share amounts) |
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STATEMENTS OF OPERATIONS (Unaudited) |
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Three Months Ended
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Six Months Ended
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2024 |
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2023 |
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2024 |
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2023 |
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Revenues: |
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Collaboration revenue |
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$ |
25,973 |
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$ |
20,013 |
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$ |
54,115 |
|
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$ |
30,356 |
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Total revenue |
|
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25,973 |
|
|
|
20,013 |
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54,115 |
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|
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30,356 |
|
Operating expenses: |
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Research and development |
|
|
45,547 |
|
|
|
39,192 |
|
|
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88,468 |
|
|
|
77,244 |
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General and administrative |
|
|
12,182 |
|
|
|
8,676 |
|
|
|
21,980 |
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|
|
20,483 |
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Total operating expenses |
|
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57,729 |
|
|
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47,868 |
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|
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110,448 |
|
|
|
97,727 |
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Loss from operations |
|
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(31,756) |
|
|
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(27,855) |
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|
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(56,333) |
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|
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(67,371) |
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Other income (expense): |
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Interest expense |
|
|
(2,259) |
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|
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(2,141) |
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|
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(4,512) |
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|
|
(4,169) |
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Other income, net |
|
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2,644 |
|
|
|
2,540 |
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|
|
5,200 |
|
|
|
5,237 |
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Net income (loss) |
|
$ |
(31,371) |
|
|
$ |
(27,456) |
|
|
$ |
(55,645) |
|
|
$ |
(66,303) |
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Net income (loss) per share, basic and diluted |
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$ |
(0.32) |
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$ |
(0.32) |
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|
$ |
(0.58) |
|
|
$ |
(0.77) |
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Weighted-average number of shares outstanding, basic and diluted |
|
|
96,965,025 |
|
|
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86,794,697 |
|
|
|
96,492,301 |
|
|
|
86,531,422 |
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SELECTED BALANCE SHEET DATA |
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June
30,
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(Unaudited) |
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Cash, cash equivalents and short-term investments |
|
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$ 237,812 |
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|
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$ 212,202 |
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Total assets |
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|
298,686 |
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|
|
273,885 |
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Total liabilities |
|
|
237,869 |
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170,184 |
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Total stockholders' equity |
|
|
60,817 |
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|
103,701 |
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