Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq:
TCRT), a clinical-stage oncology-focused cell therapy company today
announced financial results for the third quarter ended September
30, 2022.
“Our team has worked diligently over the past
year to transform our promising technology and scientific
foundation into meaningful clinical progress. We were excited to
present early data from our TCR-T Library Phase 1/2 trial at CICON,
where we showed for the very first time, an objective clinical
response in a solid tumor using a non-viral TCR-T cell therapy.
These initial safety, persistence and efficacy data reinforce the
promise of our Sleeping Beauty TCR-T cell therapy to safely achieve
measurable regression in solid tumors, even at the lowest dose,”
commented Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos.
“In tandem, we have successfully doubled our manufacturing
capacity. We look forward to dosing the next patient in our TCR-T
Library Phase 1/2 Trial as well as filing an IND amendment to
expand our TCR Library and enhance the speed and flexibility of our
manufacturing process using cryopreserved cell products in the
fourth quarter.”
Recent Developments and Upcoming
Milestones
Presented encouraging clinical data from
TCR-T Library Phase 1/2 Trial at CRI-ENCI-AACR Sixth International
Cancer Immunotherapy Conference (CICON): In September
2022, the Company presented early data from its TCR-T Library Phase
1/2 trial targeting KRAS, TP53, and EGFR mutations across six solid
tumor indications. The data represent the first report of a
successful TCR-T cell therapy using the non-viral Sleeping Beauty
system for solid tumors. The Company expects to dose the next
patient in the study in 4Q22.
Key highlights include:
- First patient dosed was diagnosed
with NSCLC and was treated at dose level 1 with TCR-T cells
targeting a KRAS G12D mutation. The patient achieved six-month
progression-free survival, with a best overall response of
objective, partial regression of greater than 50% of target lesions
at 12 weeks post-cell therapy.
- Second patient dosed was diagnosed
with colorectal cancer and was treated at dose level 2 with TCR-T
cells targeting a TP53 R175H mutation. This patient achieved a best
overall response of stable disease at six weeks with 12-week
progression-free survival.
- Persistence of TCR-T cells was
evident in both patients. Patient 1 had persistence at 24 weeks
with approximately 30% of all T-cells being TCR-T cells in the
blood. Patient 2 had persistence at 12 weeks with approximately 20%
of all T-cells being TCR-T cells in the blood.
- In both patients, the TCR-T cell
therapy was well-tolerated and presented a manageable safety
profile, with no dose limiting toxicities or immune effector
cell-associated neurotoxicity syndrome (ICANS) observed.
Additional information about the trial is
available at www.clinicaltrials.gov using the identifier:
NCT05194735.
Expanded manufacturing capacity to produce two products
simultaneously: The Company continues to execute on its
multi-pronged strategy to expand manufacturing capacity. As a
result of this initiative, the Company has doubled its existing
manufacturing capacity to produce two products simultaneously.
Expect to file IND amendment in 4Q22 to expand its TCR
Library and move from a fresh to cryopreserved manufacturing
process: Alaunos expects to file an IND amendment in the
fourth quarter, which will add two new TCRs to the Company’s TCR
Library targeting frequent mutations and HLAs. This should allow
the Company to increase the potential addressable market for its
T-cell therapies. In addition, the Company has successfully
completed process qualification runs using cryopreserved cell
products to manufacture TCR-T cells, which reduces manufacturing
process time from 30 days to 26 days, a 13% decrease. The IND
amendment will enable the Company to move to a cryopreserved
manufacturing process and add flexibility for patient scheduling
and treatment.
Presented data highlighting potential of
the Company’s hunTR™ platform to expand its TCR
Library at the Society for Immunotherapy of Cancer’s (SITC) 37th
Annual Meeting: In November 2022, the Company presented a
poster at the SITC annual meeting, highlighting its proprietary
hunTR™ (human neoantigen T-cell Receptor) platform. hunTR™ is a
high-throughput screening process that uses state-of-the-art
bioinformatics and next generation sequencing to interrogate and
deconvolute thousands of single T cells simultaneously. In the
study, Alaunos evaluated hundreds of thousands of
TCR+HLA+neoantigen permutations in nine patients across colorectal,
endometrial and breast cancers. All patients screened had at least
one detectable neoantigen-reactive TCR, including one shared KRAS
mutation. Further screening of additional patients only for KRAS
mutations resulted in discovery of KRAS-G12V reactive TCRs. The
Company plans to expand the application of hunTR to screen for
additional shared KRAS, TP53, and EGFR mutations in order to
rapidly advance new TCR library candidates from the lab through to
clinical translation.
Third Quarter Ended September 30, 2022
Financial Results
Collaboration Revenue:
Collaboration revenue was $2.9 million for the third quarter of
2022, compared to $0.4 million for the third quarter of 2021, an
increase of 631%. The increase was primarily due to the achievement
of sales-based milestones of darinaparsin in Japan, which was
largely offset by a one-time corresponding $2.5 million Research
& Development expense.
Research and Development
Expenses: Research and development expenses were $7.9
million for the third quarter of 2022, compared to $14.5 million
for the third quarter of 2021, a decrease of approximately 46%.
Research and Development expenses during the third quarter of 2022
included a one-time $2.5 million expense as a result of the
achievement of sales-based milestones of darinaparsin in Japan.
General and Administrative
Expenses: General and administrative expenses were $3.3
million for the third quarter of 2022, compared to $8.2 million for
the third quarter of 2021, a decrease of approximately 60%.
Net Loss: Net loss was $8.9
million, or $(0.04) per share, for the third 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 September 30, 2022, Alaunos had approximately $37.8 million in
cash and cash equivalents and restricted cash of $13.9 million.
Operating cash burn for the third quarter of 2022 was $6.1 million
compared to $9.6 million in the third quarter of 2021, a decrease
of $3.4 million or 36%.
Conference Call and Webcast
Alaunos will host a conference call and webcast
today, November 14, 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 a clinical and strategic
collaboration with 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
expected timeline for enrolling and dosing patients 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 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,
Inc.Statement of Operations(In thousands except per share
data)
|
|
For the Three Months EndedSeptember 30(Unaudited) |
|
|
2022 |
|
|
2021 |
|
Collaboration revenue |
$ |
2,911 |
|
|
398 |
|
Operating expenses: |
|
|
|
|
Research and development |
$ |
7,893 |
|
$ |
14,521 |
|
General and administrative |
|
3,282 |
|
|
8,173 |
|
Total operating expenses |
|
11,175 |
|
|
22,694 |
|
Loss from operations |
|
(8,264 |
) |
|
(22,296 |
) |
Interest expense |
|
(841 |
) |
|
(444 |
) |
Other income, net |
|
254 |
|
|
7 |
|
|
|
|
|
|
Net loss |
|
(8,851 |
) |
|
(22,733 |
) |
Basic and diluted net loss per share |
$ |
(0.04 |
) |
$ |
(0.11 |
) |
Weighted average common shares outstanding, basic and diluted |
|
215,098,995 |
|
|
214,542,465 |
|
Alaunos Therapeutics,
Inc.Selected Balance Sheet Data(In thousands)
|
|
(unaudited) |
|
(audited) |
|
|
September 30, 2022 |
|
December 31, 2021 |
Cash and cash equivalents |
$ |
37,807 |
$ |
76,054 |
Restricted cash |
$ |
13,938 |
$ |
- |
Working capital, excluding restricted cash |
$ |
8,698 |
$ |
62,790 |
Total assets |
$ |
67,344 |
$ |
94,865 |
Total stockholders’ equity |
$ |
32,113 |
$ |
58,057 |
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