$50 million
strategic investment validates Poseida's proprietary technology and
cell therapy approach and supports strategic and operational
plans
Implementing enhancements to ongoing
allogeneic programs based upon significant learnings; adjusting
guidance on clinical data updates
Extending cash runway guidance
SAN DIEGO, Aug. 7, 2023 /PRNewswire/ -- Poseida
Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and
gene therapy company advancing a new class of treatments for
patients with cancer and rare diseases, today announced a
$50 million strategic investment by
Astellas, which is comprised of the purchase of 8,333,333 shares of
common stock at $3.00 per share for
an aggregate purchase price of $25
million and an additional $25
million one-time payment for certain strategic
rights, and provided a business update.
"We are excited to announce a strategic investment by Astellas,
a premier global pharmaceutical company that shares our strategic
vision for the future of genetic engineering and cell and gene
therapies. This investment further validates our technology and
approach and also reflects our broad strategic options in
progressing the business," said Mark
Gergen, Poseida's Chief Executive Officer. "Based on this
investment and cost control measures implemented in the business,
we are extending our cash runway guidance as we remain focused on
being good stewards of capital. As we look towards the future, we
are taking recent learnings from our allogeneic programs and
implementing improvements across our clinical trials. Based on
these findings, we are adjusting guidance on data updates and look
forward to sharing clinical data highlighting some of these
enhancements at a medical meeting later this year, with plans for a
more robust clinical update to follow in mid-2024."
Allogeneic CAR-T Program Updates & Clinical Trial
Learnings
"We are continuing to advance the Phase 1 trials for both
P-BCMA-ALLO1 and P-MUC1C-ALLO1 and the data we have generated has
led us to find improvements that we believe have the potential to
greatly benefit our allogeneic portfolio," added Kristin Yarema, Ph.D., President of Cell Therapy
at Poseida. "We have implemented a number of these already in our
clinical-stage programs, as we continue steady progress in
dose-ranging and explore approaches such as raising conditioning
lymphodepletion to emerging industry norms and exploring additional
dosing and administration options. We are also improving our
manufacturing process in ways that will further increase product
yield, and are encouraged by the early signals we are seeing in
this area also. Overall, we remain highly excited about the
potential of our allogeneic platform and our ongoing opportunities
for continuous improvement."
P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate being
developed to target relapsed/refractory multiple myeloma (R/R MM)
in partnership with Roche. The Company is currently evaluating
P-BCMA-ALLO1 in a Phase 1 clinical trial and expects to present a
clinical update for the program at a medical meeting in
2023, subject to clearance with Roche. Given the
implementation of new dosing regimens, the Company expects that
there will be a limited number of patients available for evaluation
in newer cohorts. Poseida plans to provide a further clinical
update in mid-2024.
P-MUC1C-ALLO1
P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate targeting
solid tumors derived from epithelial cells, including breast and
ovarian cancers. The Company is currently evaluating P-MUC1C-ALLO1
in a Phase 1 clinical trial. The Company expects to present
clinical updates for the program at a medical meeting in 2023.
Given the implementation of new dosing regimens, the Company
expects that there will be a limited number of patients available
for evaluation in newer cohorts. Poseida plans to provide a further
clinical update in mid-2024.
P-CD19CD20-ALLO1
P-CD19CD20-ALLO1 is an allogeneic CAR-T product being developed
to target B-cell malignancies in partnership with Roche.
P-CD19CD20-ALLO1 is the Company's first dual CAR program and
contains two fully functional CAR molecules to target cells that
express either CD19 or CD20. The Company believes that by targeting
both CD19 and CD20, there is potential to overcome antigen escape
that has been observed by others. In June
2023 Poseida received IND clearance from the FDA for
P-CD19CD20-ALLO1, which the Company believes is the first
allogeneic dual CAR-T therapy targeting CD19 and CD20 antigens that
has received such clearance, and has initiated site start-up for
this program. Poseida expects to dose the first patient with
P-CD19CD20-ALLO1 in early 2024.
Gene Therapy Programs
As previously announced, Poseida's gene therapy collaboration
with Takeda was terminated in July
2023. The Company is in the process of evaluating both the
returning Takeda programs and its internal gene therapy programs to
determine which programs it will prioritize and progress
internally. In addition, the Company is actively evaluating the
potential to leverage these gene therapy programs through business
development. The Company intends to provide an update on this
evaluation when complete.
In July 2023 the FDA granted
orphan drug designation to P-OTC-101, 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.
Financial Guidance Update
"The strategic investment by Astellas, together with our
disciplined capital expenditure, cost control initiatives and
expected payments and milestones from the Roche collaboration, put
us on a firm financial foundation," said Johanna Mylet, Chief Financial Officer of
Poseida. "With these updates we have extended our cash runway based
upon current plans into early 2025. In addition, we believe that
further upside from our Roche collaboration as well as potential
business development opportunities provide additional confidence as
we enter the second half of 2023."
About Poseida Therapeutics, Inc.
Poseida Therapeutics is a clinical-stage biopharmaceutical
company advancing differentiated cell and gene therapies with the
capacity to cure certain cancers and rare diseases. The Company's
pipeline includes allogeneic CAR-T cell therapy product candidates
for both solid and liquid tumors as well as in vivo gene therapy
product candidates that address patient populations with high unmet
medical need. The Company's approach to cell and gene therapies is
based on its proprietary genetic editing platforms, including its
non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific
Gene Editing System and nanoparticle and hybrid gene delivery
technologies. The Company has formed a global strategic
collaboration with Roche to unlock the promise of cell therapies
for patients. Learn more at www.poseida.com and connect with us on
Twitter 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, the timing and completion of the
transactions with Astellas and receipt of the one-time payment;
expected plans with respect to clinical trials, including timing of
regulatory submissions and approvals and clinical data updates;
potential fees, milestones and other payments that the Company may
receive pursuant to its collaboration agreement with
Roche; 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; 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
inability, or the inability of Astellas, to satisfy the conditions
to closing for transactions with Astellas; the Company's reliance
on third parties for various aspects of its business; 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 Roche devotes to advancing development
programs under its collaboration agreement and the Company may not
receive the potential fees and payments under the collaboration
agreement and the ability of Roche to early terminate the
collaboration, such that the Company may not fully realize the
benefits of such collaboration; 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.
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SOURCE Poseida Therapeutics, Inc.