Continued Roche CAR-T partnership progress
with agreement for Poseida to initiate Phase 1b portion of P-BCMA-ALLO1 clinical
trial
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 International Myeloma
Society annual meeting in September
Continued progress on non-viral genetic
medicines pipeline, including FDA granting of INTERACT
meeting for P-FVIII-101
SAN
DIEGO, Aug. 5, 2024 /PRNewswire/ -- Poseida
Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell
therapy and genetic medicines company advancing differentiated
non-viral treatments for patients with cancer and rare diseases,
today announced updates and financial results for the second
quarter ended June 30, 2024.
![(PRNewsfoto/Poseida Therapeutics, Inc.) (PRNewsfoto/Poseida Therapeutics, Inc.)](https://mma.prnewswire.com/media/1023018/Poseida_Therapeutics_Logo_v1.jpg)
"Poseida has delivered strong progress across our pipeline of
innovative, non-viral allogeneic cell therapy and genetic medicine
programs so far in 2024, setting the stage for significant
potential catalysts in the second half of the year," said
Kristin Yarema, Ph.D., President and
Chief Executive Officer of Poseida Therapeutics. "For CAR-T, this
is highlighted by multiple clinical data readouts across our BCMA,
CD19CD20 and MUC1-C programs before year-end, the ongoing
advancement of our partnerships with Roche and Astellas, and
progress on our strategic approach to leveraging our allogeneic
platform for autoimmune disease. We also expect new data from our
genetic medicine programs that will continue to support the path
towards IND filings and potential business development
opportunities."
Recent Accomplishments
Cell Therapy
Advanced Roche partnership, securing $45 million from milestone execution in the first
half of 2024, with additional milestones anticipated in the second
half of the year, including a payment related to the planned
initiation of the Phase 1b portion of
the P-BCMA-ALLO1 clinical trial. Poseida and Roche have
aligned on the Phase 1b trial design,
which incorporates process improvements and feedback from recently
completed advisory board meetings with leading clinicians and the
study is expected to commence shortly. Poseida will continue to
have operational responsibility for the expanded Phase
1/1b trial, which will be funded by
Roche.
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. Poseida received $50 million in an upfront payment during the
second quarter of 2024 related to the initiation of the license
agreement.
Genetic Medicine
Demonstrated ongoing leadership in development of non-viral
approach to genetic medicines, supported by multiple data
presentations at the American Society of Gene and Cell Therapy
(ASGCT) 27th Annual Meeting featuring Poseida's lead
genetic medicine approaches.
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 September 2024, which
will provide Poseida with early engagement and communication with
FDA on the program, in order to support efficient development that
is aligned with FDA standards. INTERACT meetings focus on
innovative and emerging technologies covered by the FDA's
Center for Biologics Evaluation and Research (CBER).
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
held September 25-28, 2024, in
Rio 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
Poseida will host a cell
therapy-focused R&D Day on November 14,
2024, to highlight progress and further opportunities across
the Company, including its earlier stage allogeneic CAR-T pipeline.
Further details on the event will be disclosed at a later time.
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 $26.0
million for the three months ended June 30, 2024, compared to $20.0 million for the same period in 2023. The
increase was primarily due to milestone recognition and an increase
in reimbursed research and development expenses under the Roche
Collaboration Agreement.
Revenues were $54.1 million for
the six months ended June 30, 2024
compared to $30.4 million for the
same period in 2023. The increase was primarily due to milestone
recognition and an increase in reimbursed research and development
expenses under the Roche Collaboration Agreement, and revenue
recognized from the Astellas Strategic Agreements.
Research and Development Expenses
Research and
development expenses were $45.5
million for the three months ended June 30, 2024, and $88.5
million for the six months ended June 30, 2024 compared
to $39.2 million and $77.2 million for the same periods in 2023,
respectively. The increases were primarily due to an increase
in allogeneic clinical stage programs,
driven mainly by an increase in overall enrollment of the
Company's allogeneic programs and the
initiation of its third allogeneic
clinical trial, P-CD19CD20-ALLO1, and by an increase in
preclinical stage programs and other unallocated
expenses.
General and Administrative Expenses
General and
administrative expenses were $12.2
million for the three months ended June 30, 2024, compared to $8.7 million for the same period in 2023. The
increase was primarily due to higher personnel expenses, mainly
caused by an increase in stock-based compensation expense driven by
a one-time expense associated with the succession plan in which the
Company's former CEO became the Executive Chairman in 2024.
General and administrative expenses were $22.0 million for the six months ended
June 30, 2024, compared to
$20.5 million for the same
period in 2023. The increase was primarily due to higher legal
fees related to patent expenses and the Astellas Collaboration
Agreement, and higher personnel expenses, mainly caused by an
increase in stock-based compensation expense driven by a one-time
expense associated with the succession plan in which the Company's
former CEO became the Executive Chairman in 2024.
Net Loss
Net loss was $31.4 million and $55.6
million for the three and six months ended June 30, 2024, respectively, compared to net loss
of $27.5 million and $66.3 million for the three and six months ended
June 30, 2023,
respectively.
Cash Position
As of June 30,
2024, the Company's cash, cash equivalents and short-term
investments balance was $237.8
million. This includes $95
million in milestone and upfront payments generated in the
first half of 2024, consisting of a $50
million upfront payment from the Astellas collaboration and
$45 million from continued execution
in the Company's CAR-T partnership with Roche. The Company expects
that its cash, cash equivalents and short-term investments together
with these and other remaining near-term milestones and other
payments from Roche will be sufficient to fund operations into the
second half of 2025 and potential additional anticipated progress
and payments under the Roche Collaboration Agreement and/or
potential additional business development could further extend the
cash runway.
About Poseida Therapeutics, Inc.
Poseida Therapeutics
is a clinical-stage biopharmaceutical company advancing
differentiated allogeneic cell therapies and genetic medicines with
the capacity to cure certain cancers and rare diseases. The
Company's pipeline includes investigational allogeneic CAR-T cell
therapies for both solid tumors and hematologic cancers as well as
investigational in vivo genetic medicines that address patient
populations with high unmet medical need. The Company's approach is
based on its proprietary genetic editing platforms, including its
non-viral piggyBac® DNA Delivery System, Cas-CLOVER™
Site-Specific Gene Editing System, Booster Molecule and
nanoparticle gene delivery technologies, as well as in-house GMP
cell therapy manufacturing. The Company has formed strategic
collaborations with Roche and Astellas to unlock the promise of
cell therapies for cancer patients. Learn more at
www.poseida.com and connect with Poseida on X and
LinkedIn.
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 Dr. Yarema; estimates of the
Company's cash balance, cash runway, expenses, capital requirements
and any future revenue; the Company's ability to exploit and
consummate additional business development opportunities, including
with Roche and Astellas, and any anticipated impact on the
Company's cash balance and cash runway; the Company's ability to
attract and/or retain new and existing collaborators with relevant
expertise and its expectations regarding the potential benefits to
be derived from any such collaborations; and the Company's plans
and strategy with respect to developing its technologies and
product candidates. Because such statements are subject to risks
and uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. These
forward-looking statements are based upon the Company's current
expectations and involve assumptions that may never materialize or
may prove to be incorrect. Actual results could differ materially
from those anticipated in such forward-looking statements as a
result of various risks and uncertainties, which include, without
limitation, the Company's reliance on third parties for various
aspects of its business; risks associated with conducting clinical
trials; whether any of the Company's product candidates will be
shown to be safe and effective; the Company's ability to finance
continued operations; the Company's reliance on third parties for
various aspects of its business; competition in the Company's
target markets; the Company's ability to protect its intellectual
property; risks and uncertainties associated with development and
regulatory approval of novel product candidates in the
biopharmaceutical industry; the Company's ability to retain key
scientific or management personnel; the fact that the Company will
have limited control over the efforts and resources that its
collaborators devote to advancing development programs under their
respective collaboration agreements; the fact that the Company may
not receive the potential fees, reimbursements and payments under
the collaboration agreements; the ability of the Company's
collaborators to early terminate the collaborations, such that the
Company may not fully realize the benefits of the collaborations;
and the other risks described in the Company's filings with the
Securities and Exchange Commission. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. The Company undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made, except as required by
law.
Poseida
Therapeutics, Inc.
Selected Financial
Data
(In thousands,
except share and per share amounts)
|
|
|
|
STATEMENTS OF
OPERATIONS
(Unaudited)
|
|
|
|
|
|
Three Months
Ended
June 30,
|
|
|
Six Months
Ended
June 30,
|
|
|
|
2024
|
|
|
2023
|
|
|
2024
|
|
|
2023
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue
|
|
$
|
25,973
|
|
|
$
|
20,013
|
|
|
$
|
54,115
|
|
|
$
|
30,356
|
|
Total
revenue
|
|
|
25,973
|
|
|
|
20,013
|
|
|
|
54,115
|
|
|
|
30,356
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
45,547
|
|
|
|
39,192
|
|
|
|
88,468
|
|
|
|
77,244
|
|
General and
administrative
|
|
|
12,182
|
|
|
|
8,676
|
|
|
|
21,980
|
|
|
|
20,483
|
|
Total operating
expenses
|
|
|
57,729
|
|
|
|
47,868
|
|
|
|
110,448
|
|
|
|
97,727
|
|
Loss from
operations
|
|
|
(31,756)
|
|
|
|
(27,855)
|
|
|
|
(56,333)
|
|
|
|
(67,371)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
(2,259)
|
|
|
|
(2,141)
|
|
|
|
(4,512)
|
|
|
|
(4,169)
|
|
Other income,
net
|
|
|
2,644
|
|
|
|
2,540
|
|
|
|
5,200
|
|
|
|
5,237
|
|
Net income
(loss)
|
|
$
|
(31,371)
|
|
|
$
|
(27,456)
|
|
|
$
|
(55,645)
|
|
|
$
|
(66,303)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share, basic and diluted
|
|
$
|
(0.32)
|
|
|
$
|
(0.32)
|
|
|
$
|
(0.58)
|
|
|
$
|
(0.77)
|
|
Weighted-average number
of shares outstanding, basic and diluted
|
|
|
96,965,025
|
|
|
|
86,794,697
|
|
|
|
96,492,301
|
|
|
|
86,531,422
|
|
SELECTED BALANCE
SHEET DATA
|
|
|
|
|
|
June 30,
2024
|
|
|
December 31,
2023
|
|
|
|
(Unaudited)
|
|
|
|
|
Cash, cash equivalents
and short-term investments
|
|
|
$
237,812
|
|
|
|
$ 212,202
|
|
Total assets
|
|
|
298,686
|
|
|
|
273,885
|
|
Total
liabilities
|
|
|
237,869
|
|
|
|
170,184
|
|
Total stockholders'
equity
|
|
|
60,817
|
|
|
|
103,701
|
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/poseida-therapeutics-provides-updates-and-financial-results-for-the-second-quarter-of-2024-302214720.html
SOURCE Poseida Therapeutics, Inc.