SAN
DIEGO, Aug. 8, 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 financial results
for the second quarter ended June 30,
2023.
"In the second quarter, we continued to make strong progress
while sharpening our focus on our clinical pipeline and research
efforts," said Mark Gergen, Chief
Executive Officer of the Company. "As announced yesterday, we
received a strategic investment from 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. This support from yet another premier
biopharma strengthens our financial position and further validates
our proprietary technologies and cell therapy approach. As we
advance our clinical-stage allogeneic CAR-T portfolio, we continue
to make improvements based upon learnings across our programs and
look forward to providing data updates at a medical meeting later
this year. In our gene therapy portfolio, we continued to validate
our science, as highlighted by multiple presentations at the
American Society of Gene & Cell Therapy annual meeting in May.
In addition, we are excited by the return of our promising
Hemophilia A and PKU gene therapy programs from Takeda. We are in
the process of evaluating which gene therapy programs we may
advance on our own or seek to re-partner, and we look forward to
providing an update in due course."
Financial Results for the Second Quarter 2023
Revenues
Revenues were $20.0
million for the second quarter ended June 30, 2023, and $30.4
million for the six months ended June
30, 2023 compared to $2.7
million and $4.1 million for
the same periods in 2022. The increase was due to revenues earned
from the collaboration and license agreement with Roche, which
became effective in the third quarter of 2022 and $8.9 million of previously deferred revenue
recognized as a result of the previously announced termination of
our collaboration agreement with Takeda in the second quarter
of 2023.
Research and Development Expenses
Research and
development expenses were $39.2
million for the three months ended June 30, 2023, compared to $35.0 million for the same period in 2022. The
increase was primarily due to an increase in personnel expenses as
a result of increased headcount, an increase in preclinical stage
programs and other unallocated expenses due to an increase in
research collaboration activity, and an increase in facilities
expense, offset by a decrease in clinical stage programs, primarily
driven by the wind-down of clinical development activities
associated with autologous programs and related contract
termination expense in the prior year and the transition of
manufacturing to the Company's internal pilot plant for
P-BCMA-ALLO1.
For the six months ended June 30, 2023, research and
development expenses were $77.2
million, compared to $83.9
million for the same period in 2022. The decrease was
primarily due to a decrease in external costs related to clinical
stage programs primarily driven by the wind-down of clinical
development activities associated with autologous programs and
related contract termination expense in the prior year and the
transition of manufacturing to the Company's internal pilot plant
for P-BCMA-ALLO1, partially offset by an increase in external costs
related to preclinical stage programs and other unallocated
expenses due to an increase in research collaboration activity, an
increase in personnel expenses as a result of increased headcount
and an increase in facilities expense related to an additional
lease entered into in March 2022 to
support headcount growth.
General and Administrative Expenses
General and
administrative expenses for the three months ended June 30, 2023 were $8.7
million compared to $9.2
million for the same period in 2022. The decrease was
primarily due to lower headcount and facility costs.
For the six months ended June 30,
2023 and 2022, general and administrative expenses were
$20.5 million and $18.8 million, respectively. The increase was
primarily due to an accelerated stock-based compensation expense in
the first quarter of 2023 related to a one-time modification
associated with the retirement of the Company's former Executive
Chairman.
Net Loss
Net loss was $27.5
million and $66.3 million for
the three and six months ended June 30,
2023, respectively, compared to net loss of $43.0 million and $101.1
million for the three and six months ended June 30, 2022, respectively.
Cash Position
As of June 30,
2023, the Company's cash, cash equivalents and short-term
investments balance was $214.6
million. The Company expects that its cash, cash equivalents
and short-term investments together with the remaining near-term
milestones and other payments from Roche as well as the proceeds
from the Astellas strategic investment will be sufficient to fund
operations into early 2025.
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
Poseida 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,
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; estimates of
the Company's cash balance, expenses, capital requirements, any
future revenue, and need for additional financing; 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 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 the 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.
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,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue
|
|
$
|
20,013
|
|
|
$
|
2,700
|
|
|
$
|
30,356
|
|
|
$
|
4,135
|
|
Total
revenue
|
|
|
20,013
|
|
|
|
2,700
|
|
|
|
30,356
|
|
|
|
4,135
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
39,192
|
|
|
|
35,008
|
|
|
|
77,244
|
|
|
|
83,858
|
|
General and
administrative
|
|
|
8,676
|
|
|
|
9,237
|
|
|
|
20,483
|
|
|
|
18,782
|
|
Total operating
expenses
|
|
|
47,868
|
|
|
|
44,245
|
|
|
|
97,727
|
|
|
|
102,640
|
|
Loss from
operations
|
|
|
(27,855)
|
|
|
|
(41,545)
|
|
|
|
(67,371)
|
|
|
|
(98,505)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
(2,141)
|
|
|
|
(1,543)
|
|
|
|
(4,169)
|
|
|
|
(2,620)
|
|
Other income,
net
|
|
|
2,540
|
|
|
|
52
|
|
|
|
5,237
|
|
|
|
32
|
|
Net loss
|
|
$
|
(27,456)
|
|
|
$
|
(43,036)
|
|
|
$
|
(66,303)
|
|
|
$
|
(101,093)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.32)
|
|
|
$
|
(0.69)
|
|
|
$
|
(0.77)
|
|
|
$
|
(1.61)
|
|
Weighted-average number
of shares outstanding, basic and diluted
|
|
|
86,794,697
|
|
|
|
62,713,363
|
|
|
|
86,531,422
|
|
|
|
62,635,074
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SELECTED BALANCE
SHEET DATA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2023
|
|
|
December 31,
2022
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
Cash, cash equivalents
and short-term investments
|
|
|
|
|
|
|
|
|
|
$
|
214,606
|
|
|
$
|
282,493
|
|
Total assets
|
|
|
|
|
|
|
|
|
|
|
281,215
|
|
|
|
351,837
|
|
Total
liabilities
|
|
|
|
|
|
|
|
|
|
|
145,914
|
|
|
|
164,242
|
|
Total stockholders'
equity
|
|
|
|
|
|
|
|
|
|
|
135,301
|
|
|
|
187,595
|
|
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SOURCE Poseida Therapeutics, Inc.