Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq:
TCRT), a clinical-stage oncology-focused cell therapy company today
announced financial results for the first quarter ended March 31,
2022.
“Dosing of the first patient in our TCR-T
Library Phase 1/2 trial speaks to the dedication of our entire team
and reaffirms our commitment to execution. We are working to
continue enrolling patients in the trial and expect to provide an
initial look at data later this year,” commented Kevin S. Boyle,
Sr., Chief Executive Officer. “We are honored to have two posters
supporting our TCR-T platform targeting solid tumors at the
upcoming ASGCT and ASCO conferences. We believe we have positioned
Alaunos for success and look forward to continued progress.”
Recent Developments and Upcoming
Milestones
TCR-T Library Trial: In May
2022, the Company announced that it had dosed the first patient
with non-viral TCR-T cells in its TCR-T Library Phase 1/2 trial
targeting KRAS, TP53, and EGFR mutations across six solid tumor
indications. This is a major milestone for Alaunos as it also
represents the first clinical product manufactured and administered
to a patient using the Company’s in house cGMP manufacturing
facility.
The study is being conducted at The University
of Texas MD Anderson Cancer Center and is an open label, dose
escalation study, with patients to be treated in one of three
dosing cohorts: 5x109, 4x1010, or 1x1011 TCR-T cells. The trial is
enrolling patients with non-small cell lung, colorectal,
endometrial, pancreatic, ovarian, and bile duct cancers that have a
matching human leukocyte antigen (HLA) and hotspot mutation pairing
in Alaunos’ TCR-T library. The main study objectives are to define
the maximum tolerated dose, recommended phase 2 dose and safety
profile. The Company will present a trial in progress poster at the
2022 American Society of Clinical Oncology (ASCO) Annual Meeting
and expects to report initial data in the second half of 2022.
Additional information about the study is available at
www.clinicaltrials.gov using the identifier: NCT05194735.
Presenting preclinical data supporting
membrane bound IL-15 (mbIL-15) at the American
Society of Gene & Cell Therapy (ASGCT)
25th Annual Meeting:
Today, the Company will present preclinical data for its mbIL-15
program at the ASGCT 25th Annual Meeting. The poster titled,
“Stem-cell memory TCR-T cells targeting hotspot EGFR, KRAS and p53
neoantigens generated through co-expression of membrane-bound
Interleukin-15” highlights the potential of mbIL-15 to establish
long-lived tumor-specific TCR-T cells. The Company intends to file
an IND application for this program in the second half of 2023.
First Quarter Ended March 31, 2022
Financial Results
Research and Development
Expenses: Research and development expenses were $5.6
million for the first quarter of 2022, compared to $13.3 million
for the first quarter of 2021, a decrease of approximately 58%. The
decrease was primarily due to lower program-related costs as a
result of the winding down of our IL-12 and CAR-T programs and
lower employee related expenses due to our reduced headcount
following our strategic restructuring event in the third quarter of
2021.
General and Administrative
Expenses: General and administrative expenses were $3.5
million for the first quarter of 2022, compared to $8.2 million for
the first quarter of 2021, a decrease of approximately 57%. The
decrease was primarily due to lower employee related expenses due
to our reduced headcount following our strategic restructuring
event in the third quarter of 2021 and a decrease in consulting and
professional services expenses.
Net Loss: Net loss was $9.8
million, or $(0.05) per share, for the first quarter of 2022,
compared to a net loss of $21.6 million, or $(0.10) per share, for
the same period in 2021.
Cash and Cash Equivalents: As
of March 31, 2022, Alaunos had approximately $68.3 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 first quarter of 2022 was $7.8 million
compared to $15.3 million in the first quarter of 2021, a decrease
of $7.5 million or 49%.
Conference Call and Webcast
The conference call can be accessed by dialing
844-309-0618 (United States) or 661-378-9465 (International) with
the conference code 2495623. A live webcast may be accessed using
the link here, or by visiting the “Investors” section of the
Alaunos website at www.alaunos.com. 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 Company's cash runway, and the timing of the Company's research
and development programs, including the anticipated dates for
filing INDs, enrolling and dosing patients in and the expected
timing and forums 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 Form 10-Q and Form 10-K 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.
Alaunos Therapeutics,
IncStatement of Operations(In thousands except per share
data)
|
|
For the Three Months Ended March 31(Unaudited) |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
Research and development |
$ |
5,580 |
|
$ |
13,336 |
|
General and administrative |
|
3,505 |
|
|
8,227 |
|
Total operating expenses |
|
9,085 |
|
|
21,563 |
|
Loss from operations |
|
(9,085 |
) |
|
(21,563 |
) |
Other income (expense), net |
|
(703 |
) |
|
9 |
|
|
|
|
|
|
Net loss |
|
(9,788 |
) |
|
(21,554 |
) |
Net loss applicable to common stockholders |
|
(9,788 |
) |
|
(21,554 |
) |
Basic and diluted net loss per share |
$ |
(0.05 |
) |
$ |
(0.10 |
) |
Weighted average number of common shares outstanding used to
compute basic and diluted net loss per share |
|
214,946,569 |
|
|
213,954,665 |
|
Alaunos Therapeutics,
IncSelected Balance Sheet Data(In thousands)
|
|
(unaudited) |
|
(audited) |
|
|
March 31, 2022 |
|
December 31, 2021 |
Cash and cash equivalents |
|
$ |
68,255 |
|
$ |
76,054 |
Working capital |
|
$ |
48,538 |
|
$ |
62,790 |
Total assets |
|
$ |
84,991 |
|
$ |
94,865 |
Total stockholders' equity |
|
$ |
49,122 |
|
$ |
58,057 |
Investor Relations Contact:
Alex Lobo
Stern Investor Relations
Alex.lobo@sternir.com
Alaunos Therapeutics (NASDAQ:TCRT)
Historical Stock Chart
From Apr 2024 to May 2024
Alaunos Therapeutics (NASDAQ:TCRT)
Historical Stock Chart
From May 2023 to May 2024