Alaunos Therapeutics Announces Second Quarter 2023 Financial Results, Interim Clinical Data and Exploration of Strategic Alternatives
August 14 2023 - 4:05PM
Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq:
TCRT), today announced financial results for the second quarter
ended June 30, 2023. The Company also announced a strategic
reprioritization to focus on its hunTR® TCR discovery platform,
wind down its TCR-T Phase 1/2 Library trial and explore broad
strategic alternatives for the Company. Alaunos is implementing a
cost-savings plan that includes a reduction in workforce by
approximately 60%.
“Over the past two years, we have advanced the
medical field’s understanding of TCR-T cell therapies using our
innovative Sleeping Beauty technology targeting high-frequency
driver mutations,” said Kevin S. Boyle, Sr., Chief Executive
Officer of Alaunos. “We continue to believe that this approach has
potential in targeting the heart of cancer growth. However, after a
review of the funding needs of our TCR-T Library Phase 1/2 trial
and the current financial markets, the Board of Directors has made
the difficult decision to limit further drug development under our
clinical trial and to focus on our promising hunTR® TCR discovery
platform as we explore all strategic alternatives.”
Operational & Corporate
Update
Interim Clinical Data from TCR-T Library
Phase 1/2 Trial: Eight patients have been treated in the
Company’s TCR-T Library Phase 1/2 trial to date, six of which are
evaluable as of today. The trial showed that the Company’s T-cells
were generally well-tolerated in all evaluable participants and
achieved an 83% disease control rate in evaluable patients with
metastatic, refractory solid tumors. Disease control is measured by
objective responses and stable disease. Persistence of TCR-T
cells in peripheral blood was detected in all evaluable patients at
last follow-up.
hunTR® TCR Discovery Platform Identifies
Proprietary TCRs: Alaunos has discovered multiple
proprietary TCRs targeting driver mutations through its hunTR® TCR
discovery platform. The hunTR® platform can rapidly interrogate
T-cell responses and has the potential to expand to multiple
targets or cancer indications. Using hunTR®, the Company has
demonstrated the ability to isolate neoantigen specific TCRs from
tumor resident T-cells. The presence of these driver mutation
specific T-cells in the tumor potentially validates the relevance
of the mutated target and safety of the TCR for use in other cancer
patients expressing the same neoantigen.
Restructuring Organization and Winding
Down TCR-T Library Phase 1/2 Trial: Alaunos has decided to
wind down its TCR-T Library Phase 1/2 trial and prioritize the
hunTR® platform to explore potential partnering opportunities.
Concurrently, the Company is exploring strategic alternatives and
has engaged Cantor Fitzgerald & Co. to act as a strategic
advisor for this process. Strategic options may include but are not
limited to, an acquisition, merger, reverse merger, sale of assets,
strategic partnerships, capital raises or other transactions. The
Company will reduce its workforce by approximately 60% to
streamline the organization, while retaining key R&D
capabilities for the hunTR® platform and to assist
in the strategic alternatives review process. Alaunos does not
intend to comment further on this process unless or until its Board
of Directors has approved a definitive course of action or it is
determined that other disclosure is appropriate.
Second Quarter Ended June 30, 2023,
Financial Results
Research and Development
Expenses: Research and development expenses were $5.2
million for the second quarter of 2023, compared to $5.9 million
for the second quarter of 2022, a decrease of approximately 13%.
The decrease was primarily due to an accrual adjustment related to
one of our de-prioritized clinical programs of $0.7 million.
General and Administrative
Expenses: General and administrative expenses were $3.0
million for the second quarter of 2023, compared to $3.4 million
for the second quarter of 2022, a decrease of approximately 11%.
The decrease was primarily due to lower employee-related expenses
of $0.1 million due to our reduced headcount, a $0.1 million
decrease in consulting and professional services related to lower
legal fees and the reduced use of consultants, and a $0.2 million
decrease in insurance fees.
Net Loss: Net loss was $8.8
million, or $(0.04) per share, for the second quarter of 2023,
compared to a net loss of $9.9 million, or $(0.05) per share, for
the second quarter in 2022.
Cash, Cash Equivalents and Restricted
Cash: As of June 30, 2023, Alaunos had approximately $18.3
million in cash balances. The Company expects to have sufficient
cash resources to fund operations into the fourth quarter of 2023,
after implementing the strategic reprioritization laid out
above.
About Alaunos Therapeutics,
Inc.Alaunos Therapeutics is a T-cell receptor (TCR) cell
therapy company powered by its hunTR® (human neoantigen T-cell
Receptor) discovery platform. hunTR® enables the rapid
identification of wholly owned, proprietary TCRs. Using a
proprietary high-throughput TCR screening process, hunTR® enables
rapid functional validation of TCRs potentially allowing Alaunos to
advance new TCRs from the lab to testing in the clinic. 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 evaluating strategic alternatives
and the potential outcomes; the completion and impact of the
reduction in workforce; the planned renewed focus on the hunTR® TCR
discovery platform and its success, including its ability to
discover additional TCRs and the ability to monetize any newly
discovered TCRs; the wind down of the TCR-T Phase 1/2 Library
trial; and the results and potential of the TCR-T Phase 1/2 Library
trial.. 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, risks relating to volatility and uncertainty in the
capital markets for biotechnology and cell therapy companies;
availability of suitable third parties with which to conduct
contemplated strategic transactions; whether the Company will be
able to pursue a strategic transaction, or whether any transaction,
if pursued, will be completed successfully and on attractive terms
or at all; whether our cash resources will be sufficient to fund
the Company’s foreseeable and unforeseeable operating expenses and
capital requirements; 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; the
risks associated with reductions in workforce, including reduced
morale and attrition of additional employees necessary for the
strategic reprioritization; the Company’s exclusive focus on its
hunTR® TCR discovery platform; the strength and enforceability of
Alaunos’ intellectual property rights; competition from other
pharmaceutical and biotechnology companies; the impacts related to
or resulting from recent bank failures and other economic and
industry volatility; and 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) |
|
|
|
For the Three Months EndedJune 30(Unaudited) |
|
|
2023 |
|
2022 |
Collaboration revenue |
$ |
4 |
|
$ |
- |
|
Operating expenses: |
|
|
|
|
Research and development |
$ |
5,186 |
|
$ |
5,937 |
|
General and administrative |
|
3,045 |
|
|
3,429 |
|
Gain on lease modification |
|
(245 |
) |
|
(133 |
) |
Total operating expenses |
|
7,986 |
|
|
9,233 |
|
Loss from operations |
|
(7,982 |
) |
|
(9,233 |
) |
Interest expense |
|
(1,068 |
) |
|
(740 |
) |
Other income, net |
|
277 |
|
|
41 |
|
|
|
|
|
|
Net loss |
|
(8,773 |
) |
|
(9,932 |
) |
Basic and diluted net loss per share |
$ |
(0.04 |
) |
$ |
(0.05 |
) |
Weighted average common shares outstanding, basic and diluted |
|
239,797,574 |
|
|
214,998,893 |
|
Alaunos Therapeutics, Inc.Selected Balance Sheet
Data(In thousands) |
|
|
|
|
|
|
June 30,2023(Unaudited) |
|
December 31,2022(Audited) |
Cash and cash equivalents |
$ |
18,317 |
$ |
39,058 |
Restricted cash |
$ |
- |
$ |
13,938 |
Working capital, excluding restricted cash |
$ |
13,726 |
$ |
15,695 |
Total assets |
$ |
27,927 |
$ |
64,937 |
Total stockholders’ equity |
$ |
21,650 |
$ |
38,555 |
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