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On February 18, 2026, Allarity Therapeutics, Inc.
(the “Company”) announced that the first patients have been dosed with stenoparib and temozolomide in the VA-funded investigator-initiated
Phase 2 trial for the treatment of relapsed small cell lung cancer. The Company’s press release is filed as Exhibit 99.1 to this
Current Report on Form 8-K and is incorporated herein by reference.
(d) Exhibits.
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Exhibit 99.1
Allarity Therapeutics Doses First
Patients in VA-Funded Phase 2 Trial Focused on Small Cell Lung Cancer with High Unmet Need
- Stenoparib is being evaluated in combination with temozolomide clinical benefit in relapsed Small Cell Lung Cancer
- Trial is fully funded by the U.S. Department of Veterans Affairs and is open for enrollment at 11 VA sites nationwide
- Relapsed SCLC remains an area of high unmet need without effective treatment options
TARPON SPRINGS, Fla., February 18, 2026 – Allarity Therapeutics,
Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to
developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor—today announced that the first patients
have been dosed with stenoparib and temozolomide in the VA-funded investigator-initiated Phase 2 trial for the treatment of relapsed small
cell lung cancer (SCLC).
This trial is being conducted in collaboration with the U.S. Department
of Veterans Affairs (VA) and is fully funded through the VA’s Special Emphasis Panel on Precision Oncology. Patient recruitment
is ongoing across 11 VA medical centers throughout the United States.
Stenoparib offers a differentiated mechanism of action that simultaneously
disrupts DNA repair while also inhibiting the WNT/Beta Catenin oncogenic signaling pathway. It is hypothesized that this dual action may
help accentuate the DNA damaging effects of temozolomide while also restraining the WNT pathway that has been frequently associated with
drug resistance as well as the aberrant and aggressive behavior of advanced cancers such as relapsed SCLC.
“We are pleased to report that these patients have now received
the first doses of stenoparib in combination with temozolomide. We are encouraged by the speed of enrollment, which reflects enthusiasm
for this combination as well as the significant unmet medical need in relapsed small cell lung cancer,” said Thomas Jensen, Chief
Executive Officer of Allarity Therapeutics. “Prior studies have combined PARP inhibitors and temozolomide with great early effect
but were severely limited by the toxicities of the first-generation PARP inhibitors when combined with temozolomide. The clinical experience
with stenoparib to date has shown that it is well tolerated and may therefore be an ideal agent for combination with temozolomide in relapsed
SCLC.”
Allarity Therapeutics, Inc.
I 123 E Tarpon Ave I Tarpon Springs, Florida I U.S.A. I NASDAQ: ALLR I www.allarity.com
Unlike earlier-generation PARP inhibitors, which have shown limited
use in SCLC due to dose-limiting hematologic toxicity, stenoparib’s favorable safety profile may allow for more tolerable and sustained
combination therapy. This combination with temozolomide, an alkylating chemotherapy agent, is designed to maximize tumor cell death while
reducing toxicity risks.
According to CDC U.S. Cancer Statistics, more than 218,000 Americans
are diagnosed with lung cancer each year, and approximately 12% of cases are small cell lung cancer (SCLC).
Nearly 60–70% of SCLC patients present with extensive-stage disease
at diagnosis. Despite the availability of approved second-line agents, real-world data indicate that only 40% receive second-line treatment,
with median treatment duration under two months—highlighting the continued unmet need in relapsed SCLC.
Stenoparib’s ability to cross the blood-brain barrier adds further
clinical relevance in SCLC, where brain metastases are a common and difficult-to-treat complication.
About Stenoparib/2X-121
Stenoparib is an
orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant
attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant
WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking
WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types,
including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development
and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and
2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had
2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues
for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented
at this AACR special conference on advances in Ovarian Cancer. Note that, as these data are from an ongoing trial, analyses may change
as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib
in platinum resistant patients began enrolling patients this summer. This amended protocol enrolls only platinum resistant or platinum-ineligible
patients and is designed to accelerate the clinical development of stenoparib toward FDA approval.
About the Drug Response Predictor –
DRP® Companion Diagnostic
Allarity uses its drug-specific DRP® to select
those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By
screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic
benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic
information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger
RNA expression profiles from patient biopsies. The DRP® platform has shown an ability to provide a statistically significant
prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective).
The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published
in the peer-reviewed literature.
Allarity Therapeutics, Inc.
I 123 E Tarpon Ave I Tarpon Springs, Florida I U.S.A. I NASDAQ: ALLR I www.allarity.com
About Allarity Therapeutics
Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical
company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase
inhibitor for advanced ovarian cancer patients, using its DRP® technology to develop a companion diagnostic that can
be used to select those patients expected to derive the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S.,
with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information,
visit www.allarity.com.
Follow Allarity on Social Media
LinkedIn: https://www.linkedin.com/company/allaritytx/
Forward-Looking Statements
This press release contains “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company’s current
expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,”
“potential,” “predicts,” “project,” “should,” “would” and similar expressions
may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking
statements include, but are not limited to, statements regarding the continued clinical development of stenoparib (2X-121) in advanced
ovarian cancer and small cell lung cancer; the initiation, enrollment, and expected data readouts from ongoing and future clinical trials;
including the trial with the U.S. Department of Veterans Affairs (VA);the potential safety, efficacy, and durability of clinical benefit
of stenoparib; stenoparib’s safety and efficacy in combination with temozolomide; the potential for regulatory advancement, including
under FDA Fast Track designation; and the expansion and potential commercial application of the Company’s DRP® companion diagnostic
platform, including in antibody-based therapies. Any forward-looking statements in this press release are based on management’s
current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not
limited to, risks related to clinical development and regulatory review, including the possibility that future clinical data may not support
safety or efficacy claims; delays in patient enrollment or trial completion; reliance on third-party investigators and trial sites; the
outcome and timing of decisions by regulatory authorities, including under Fast Track designation; the predictive accuracy and clinical
utility of the DRP® platform; and the Company’s ability to secure sufficient funding or partnerships to support its operations
and development plans. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual
results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Form
10-K annual report filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2025, and our Form 10-Q quarterly
reports filed with the SEC on May 9, 2025, August 15, 2025 and November 14, 2025, available at the SEC’s website at www.sec.gov,
and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with
the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information
unless required by law.
###
Company Contact:
investorrelations@allarity.com
Media Contact:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
tsp@carrotize.com
Allarity Therapeutics, Inc. I 123 E Tarpon
Ave I Tarpon Springs, Florida I U.S.A. I NASDAQ: ALLR I www.allarity.com
