Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq:
TCRT), a leading T-cell receptor (TCR) cell therapy company
advancing a clinical-stage pipeline of therapeutics for solid
tumors, today announced financial results for the first quarter
ended March 31, 2023, and provided a corporate update.
“Our TCR-T Library Phase 1/2 trial continues to
garner significant interest among patients, physicians and
investigators,” said Kevin S. Boyle, Sr., Chief Executive Officer
of Alaunos. “We’ve been actively enrolling patients and
manufacturing cryopreserved products, and we expect to report
interim clinical data in the third quarter of this year. As we work
to fully realize the long-term potential of our TCR-T platform, we
have simplified our corporate structure with the full prepayment of
our loan with SVB and the recent agreement with Precigen. We are
now moving forward unencumbered by debt or these potential
royalties as we seek to transform the treatment of solid
tumors.”
Recent Developments and Upcoming
Milestones
TCR-T Library Phase 1/2 trial actively
enrolling patients: Alaunos continues to actively enroll
patients in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53
and EGFR driver mutations across six solid tumor indications. Early
translational data from the first three patients treated in the
program will be highlighted in a poster at the 2023 American
Society of Clinical Oncology (ASCO) Annual Meeting taking place
June 2-6, 2023. Alaunos currently expects to provide an interim
data update on multiple new patients in the third quarter of this
year as the Company advances the program towards Phase 2 readiness
with a recommended Phase 2 dose anticipated by year end 2023.
Manufactured multiple cryopreserved
products: In the first quarter of 2023, Alaunos enhanced
its manufacturing process to move from fresh to cryopreserved cell
product enabling greater flexibility for patient scheduling and
treatment. To date, the Company has manufactured multiple
cryopreserved products with viability, purity and TCR positivity
comparable to our prior process.
Completed full prepayment of amended
loan and security agreement with Silicon Valley Bank
(SVB): In May 2023, Alaunos fully prepaid the remaining
amounts owed under its term loan with SVB, which was $11.0 million
as of March 31, 2023. With no remaining obligations due to SVB, the
restricted cash balance of $13.9 million as of March 31, 2023, has
also been released.
Amended exclusive license agreement with
Precigen, Inc.; Alaunos maintains exclusive rights to TCRs
using Sleeping Beauty targeting
driver mutations: In April 2023, Alaunos amended its
exclusive license agreement with Precigen. Under the terms of the
amended agreement, Alaunos maintains exclusive rights to TCRs using
Sleeping Beauty targeting driver mutations, while Precigen regains
the rights to its CAR-T and IL-12 assets. The amended agreement
eliminated all commercial sales-based royalties and milestone
obligations, in alignment with Alaunos’ focus on its priority TCR-T
programs.
Expanded infrastructure of hunTR® TCR
discovery platform to increase throughput; expect to add three new
TCRs in 2023: In the first quarter of 2023, Alaunos
significantly increased the throughput potential of its hunTR® TCR
discovery platform to further accelerate TCR discovery and
validation. New lab equipment and advanced bioinformatics
capabilities have multiplied the screening throughput while
maintaining a high success rate of TCR discovery. The Company
expects to add three new TCRs to its library, potentially bringing
the total number of unique TCRs to 15 by the end of 2023.
Appointed Robert Hofmeister, PhD, MS, to
Board of Directors: In March 2023, Alaunos appointed
Robert J. Hofmeister, PhD, MS, to the Company’s board of directors.
Dr. Hofmeister brings deep expertise in the discovery and
development of engineered T-cell receptor therapies as well as a
background in cellular immunology and translational science. He is
currently Chief Scientific Officer of a stealth early-stage
biotechnology company and was most recently Chief Scientific
Officer at TCR2 Therapeutics.
First Quarter Ended March 31, 2023,
Financial Results
Research and Development
Expenses: Research and development expenses were $6.5
million for the first quarter of 2023, compared to $5.6 million for
the first quarter of 2022, an increase of approximately 17%. The
increase was primarily due to incremental manufacturing activities
related to the TCR-T Library Phase 1/2 trial and hunTR® research
efforts of $1.7 million, partially offset by a $0.7 million
decrease in employee-related expenses.
General and Administrative
Expenses: General and administrative expenses were $3.2
million for the first quarter of 2023, compared to $3.5 million for
the first quarter of 2022, a decrease of approximately 10%. The
decrease was primarily due to lower professional fees of $0.2
million.
Net Loss: Net loss was $10.0
million, or $(0.04) per share, for the first quarter of 2023,
compared to a net loss of $9.8 million, or $(0.05) per share, for
the first quarter of 2022.
Cash, Cash Equivalents and Restricted
Cash: As of March 31, 2023, Alaunos had approximately
$37.4 million in cash balances, which included restricted cash of
approximately $13.9 million. Based on current operating plans, the
Company expects its operating outflows, excluding debt service
costs, for 2023 to be between approximately $35 million and $40
million. The Company expects to have sufficient cash resources to
fund research and development programs and operations into the
fourth quarter of 2023.
Conference Call and Webcast
Alaunos will host a conference call and webcast
today, May 10, 2023, at 9:00 a.m. ET. Participants may access the
live webcast using the link here or by visiting the “Investors”
section of the Alaunos website at www.alaunos.com. To participate
via telephone, please register in advance at this link. Upon
registration, all telephone participants will receive a
confirmation email detailing how to join the conference call,
including the dial-in number along with a unique passcode and
registrant ID that can be used to access the call. The event will
be archived on the Company’s website for approximately 30 days
after the call.
About Alaunos Therapeutics,
Inc.Alaunos Therapeutics is a leader in the science of
T-cell receptor cell therapy working to revolutionize solid cancer
treatment and outcomes. The clinical-stage company’s TCR T-cell
therapy (TCR-T) is one of the most advanced TCR programs targeting
driver mutations in solid tumors with an ongoing Phase 1/2 trial of
its TCR-T product candidates across six solid cancers. Alaunos is
powered by two proprietary platforms: its elegantly efficient
non-viral Sleeping Beauty cell engineering platform; and its hunTR®
discovery platform, which is expanding its industry-leading library
of TCRs against high-frequency driver mutations. Alaunos is a part
of an ongoing collaboration with the National Cancer Institute
(NCI), part of the National Institutes of Health (NIH), working to
advance the science of TCR therapy. For more information,
visit www.alaunos.com.
Forward-Looking Statements
Disclaimer This press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts, and in some cases can be identified
by terms such as “may,” “will,” “could,” “expects,” “plans,”
“anticipates,” “believes” or other words or terms of similar
meaning. These statements include, but are not limited to,
statements regarding the Company's business and strategic plans,
the anticipated outcome of preclinical and clinical studies by the
Company or its third-party collaborators, the Company’s cash runway
and forecasted operating cash flow, the Company’s manufacturing
capabilities and the timing of the Company's research and
development programs, including the expected timeline for enrolling
and dosing patients, submitting and receiving approvals on INDs and
similar regulatory submissions and the timing and forums for
announcing data from the Company's clinical trials. Although the
management team of Alaunos believes that the expectations reflected
in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are
subject to various risks and uncertainties, many of which are
difficult to predict and generally beyond the control of Alaunos,
that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and
uncertainties include, among other things, changes in the Company’s
operating plans that may impact its cash expenditures; the
uncertainties inherent in research and development, future clinical
data and analysis, including whether any of Alaunos’ product
candidates will advance further in the preclinical research or
clinical trial process, including receiving clearance from the U.S.
Food and Drug Administration or equivalent foreign regulatory
agencies to conduct clinical trials and whether and when, if at
all, they will receive final approval from the U.S. Food and Drug
Administration or equivalent foreign regulatory agencies and for
which indication; the strength and enforceability of Alaunos’
intellectual property rights; and competition from other
pharmaceutical and biotechnology companies; the impacts related to
or resulting from recent bank failures and other economic and
industry volatility; the potential delisting of the Company’s
common stock from the Nasdaq Stock Market LLC, as well as risk
factors discussed or identified in the public filings with the
Securities and Exchange Commission made by Alaunos, including those
risks and uncertainties listed in the most recent periodic report
filed by Alaunos with the Securities and Exchange Commission.
Alaunos is providing this information as of the date of this press
release, and Alaunos does not undertake any obligation to update or
revise the information contained in this press release whether as a
result of new information, future events, or any other reason.
Investor Relations Contact:Alex
LoboStern Investor RelationsAlex.lobo@sternir.com
Media Contact:Heather Anderson6
Degrees PRhanderson@6degreespr.com
Alaunos Therapeutics, Inc.Statement of
Operations(In thousands except per share data) |
|
|
|
|
|
Three Months EndedMarch 31(Unaudited) |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
Research and development |
$ |
6,504 |
|
$ |
5,580 |
|
General and administrative |
|
3,168 |
|
|
3,505 |
|
Total operating expenses |
|
9,672 |
|
|
9,085 |
|
Loss from operations |
|
(9,672 |
) |
|
(9,085 |
) |
Interest expense |
|
(853 |
) |
|
(683 |
) |
Other income (expense), net |
|
477 |
|
|
(20 |
) |
|
|
|
|
|
Net loss |
|
(10,048 |
) |
|
(9,788 |
) |
Basic and diluted net loss per share |
$ |
(0.04 |
) |
$ |
(0.05 |
) |
Weighted average common shares outstanding, basic and diluted |
|
239,679,352 |
|
|
214,946,569 |
|
Alaunos Therapeutics, Inc.Selected Balance Sheet
Data(In thousands) |
|
|
|
|
|
March 31,2023(Unaudited) |
|
December 31,2022(Audited) |
Cash and cash equivalents |
$ |
23,496 |
$ |
39,058 |
Restricted cash |
$ |
13,938 |
$ |
13,938 |
Working capital, excluding restricted cash |
$ |
7,183 |
$ |
15,695 |
Total assets |
$ |
48,638 |
$ |
64,937 |
Total stockholders’ equity |
$ |
29,509 |
$ |
38,555 |
Alaunos Therapeutics (NASDAQ:TCRT)
過去 株価チャート
から 4 2024 まで 5 2024
Alaunos Therapeutics (NASDAQ:TCRT)
過去 株価チャート
から 5 2023 まで 5 2024