Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq:
TCRT), a clinical-stage oncology-focused cell therapy company today
announced financial results for the second quarter ended June 30,
2022.
“The team has made tremendous progress building
a strong operational, manufacturing, and clinical foundation over
the past year. Our TCR-T Library Phase 1/2 trial is actively
enrolling, and I am pleased to announce that we are moving ahead at
the second dose level,” commented Kevin S. Boyle, Sr., Chief
Executive Officer of Alaunos. “The recent hiring of Abhi Srivastava
as our VP of Technical Operations strengthens our manufacturing
capabilities as we work to increase our manufacturing capacity to
support future clinical expansion. In addition to our internal
efforts, we were privileged to extend our collaboration with Dr.
Rosenberg and the National Cancer Institute to develop personalized
cancer therapies using our novel TCR-T cell platform. We believe
that Alaunos is poised for long term success. We look forward to
presenting early data from our Phase 1/2 trial in the third quarter
and remain committed to improving the lives of cancer patients with
solid tumors.”
Recent Developments and Upcoming
Milestones
TCR-T Library Phase 1/2 Trial:
The Company continues to advance its TCR-T Library Phase 1/2 trial
targeting KRAS, TP53, and EGFR mutations across six solid tumor
indications. In May 2022, the Company announced dosing of the first
patient in the trial. The patient has non-small cell lung cancer
and was treated with TCR-T cells targeting a KRAS G12D mutation.
Following a safety review by the safety review committee at the MD
Anderson Cancer Center, the Company is now moving ahead at the
second dose level. The main study objectives are to define the
maximum tolerated dose, recommended Phase 2 dose and safety
profile. The Company expects to present early data in the third
quarter of 2022. Additional information about the trial is
available at www.clinicaltrials.gov using the identifier:
NCT05194735.
Extended Cooperative Research and
Development Agreement (CRADA) with the National Cancer Institute
(NCI) for Development of Personalized TCR-T Cell
Therapies: In June 2022, the Company announced that it had
extended its CRADA with the NCI, regarding the Company’s Sleeping
Beauty technology, through January 2025. Under the CRADA, the NCI
will work to generate proof of concept data utilizing the Company’s
proprietary non-viral Sleeping Beauty technology for personalized
TCR-T cell therapies. In this approach, T-cell receptors (TCRs)
that react to the patient’s tumor are identified from the patient
and used in an effort to generate a fully autologous, personalized
TCR-T cell therapy. Research conducted under the CRADA will be led
by Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at
the NCI's Center for Cancer Research.
cGMP Manufacturing Facility:
The Company’s state-of-the-art good manufacturing practice (cGMP)
TCR manufacturing facility is fully operational for the manufacture
and release of clinical product. The Company is executing on a
multi-pronged strategy to expand its manufacturing capabilities.
Alaunos is implementing new standard operating procedures that
allow for simultaneous production of multiple products, including
further optimizing the manufacturing process by introducing
cryopreserved cell products. In addition, the Company is hiring
additional staff to support increased manufacturing and is
evaluating additional strategies including physically expanding its
cGMP footprint.
Corporate Updates: In August
2022, Abhishek Srivastava, Ph.D. was appointed Vice President,
Technical Operations. Dr. Srivastava joined Alaunos from Athenex,
where he was Vice President, Cell Therapy Development.
Second Quarter Ended June 30, 2022
Financial Results
Research and Development
Expenses: Research and development expenses were $5.9
million for the second quarter of 2022, compared to $13.6 million
for the second quarter of 2021, a decrease of approximately 56%.
The decrease was primarily due to lower program-related costs of
$2.0 million as a result of the winding down of the Company’s IL-12
and CAR-T programs, a $5.2 million decrease in employee related
expenses due to reduced headcount following the restructuring in
the third quarter of 2021, and a $0.3 million decrease in
consulting expenses.
General and Administrative
Expenses: General and administrative expenses were $3.4
million for the second quarter of 2022, compared to $9.1 million
for the second quarter of 2021, a decrease of approximately 62%.
The decrease was primarily due to lower employee related expenses
of $5.4 million due to reduced headcount following the
restructuring in the third quarter of 2021 and a $0.2 million
decrease in consulting and professional services expenses.
Net Loss: Net loss was $9.9
million, or $(0.05) per share, for the second quarter of 2022,
compared to a net loss of $22.7 million, or $(0.11) per share, for
the same period in 2021.
Cash and Cash Equivalents: As
of June 30, 2022, Alaunos had approximately $60.0 million in cash
and cash equivalents. The Company anticipates its cash runway will
be sufficient to fund operations into the second quarter of 2023.
Operating cash burn for the second quarter of 2022 was $8.2 million
compared to $21.5 million in the second quarter of 2021, a decrease
of $13.3 million or 62%.
Conference Call and Webcast
Alaunos will host a conference call and webcast
today, August 15, 2022, at 8:30am 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. After the live
webcast, the event will be archived on the Company’s website for
approximately 30 days after the call.
About Alaunos
TherapeuticsAlaunos is a clinical-stage oncology-focused
cell therapy company, focused on developing T-cell receptor (TCR)
therapies based on its proprietary, non-viral Sleeping Beauty gene
transfer technology and its TCR library targeting shared
tumor-specific hotspot mutations in key oncogenic genes including
KRAS, TP53 and EGFR. The Company has clinical and strategic
collaborations with The University of Texas MD Anderson Cancer
Center and the National Cancer Institute. For more information,
please 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, the Company’s manufacturing capabilities, and the timing of
the Company's research and development programs, including the
anticipated dates for enrolling and dosing patients in and the
expected timing for announcing preclinical data and results 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 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
Alaunos Therapeutics,
IncStatement of Operations(In thousands except per share
data)
|
|
For the Three Months EndedJune 30(Unaudited) |
|
|
2022 |
|
2021 |
Operating Expenses: |
|
|
|
|
Research and development |
$ |
5,937 |
|
$ |
13,570 |
|
General and administrative |
|
3,429 |
|
|
9,069 |
|
Gain on lease modification |
|
(133 |
) |
|
— |
|
Total operating expenses |
|
9,233 |
|
|
22,639 |
|
Loss from operations |
|
(9,233 |
) |
|
(22,639 |
) |
Interest expense |
|
(740 |
) |
|
— |
|
Other income (expense), net |
|
41 |
|
|
(31 |
) |
|
|
|
|
|
Net loss |
|
(9,932 |
) |
|
(22,670 |
) |
Net loss applicable to common stockholders |
|
(9,932 |
) |
|
(22,670 |
) |
Basic and diluted net loss per share |
$ |
(0.05 |
) |
$ |
(0.11 |
) |
Weighted average number of common shares outstanding, basic and
diluted |
|
214,998,893 |
|
|
214,426,406 |
|
Alaunos Therapeutics,
IncSelected Balance Sheet Data(In thousands)
|
|
(unaudited) |
|
(audited) |
|
|
June 30, 2022 |
|
December 31, 2021 |
Cash and cash equivalents |
$ |
60,011 |
$ |
76,054 |
Working capital |
$ |
34,586 |
$ |
62,790 |
Total assets |
$ |
73,931 |
$ |
94,865 |
Total stockholders’ equity |
$ |
40,180 |
$ |
58,057 |
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