Allarity Therapeutics Doses First Patients in VA-Funded Phase 2 Trial Focused on Small Cell Lung Cancer with High Unmet Need

Rhea-AI Summary

Allarity Therapeutics (NASDAQ: ALLR) announced dosing of the first patients in a VA-funded investigator-initiated Phase 2 trial evaluating stenoparib plus temozolomide for relapsed small cell lung cancer (SCLC) on February 18, 2026. The trial is open at 11 VA sites and fully funded by the U.S. Department of Veterans Affairs.

Stenoparib is a dual PARP and WNT pathway inhibitor with reported blood-brain barrier penetration; the combination aims to enhance temozolomide efficacy while potentially reducing toxicity seen with earlier PARP inhibitors.

Positive

• Dosed first patients in a Phase 2 trial on Feb 18, 2026
• Trial is fully funded by the U.S. Department of Veterans Affairs
• Active enrollment across 11 VA medical centers
• Stenoparib reported to cross the blood-brain barrier

Negative

• Only 40% of relapsed SCLC patients receive second-line therapy
• Median second-line treatment duration is under two months
• Earlier-generation PARP inhibitors showed dose-limiting hematologic toxicity

Key Figures

VA trial sites: 11 sites Annual US lung cancer cases: 218,000 SCLC share of lung cancer: 12% +4 more

7 metrics

VA trial sites 11 sites VA-funded Phase 2 SCLC trial enrollment locations

Annual US lung cancer cases 218,000 CDC U.S. Cancer Statistics cited in article

SCLC share of lung cancer 12% Proportion of lung cancer cases that are SCLC

Extensive-stage SCLC at diagnosis 60–70% Patients presenting with extensive-stage disease

Second-line treatment rate 40% Share of SCLC patients receiving second-line therapy

Second-line duration under two months Median duration of second-line treatment in real-world data

Trial phase Phase 2 Investigator-initiated SCLC combination study

Market Reality Check

Price: $0.8300 Vol: Volume 136,313 vs 20-day ...

normal vol

$0.8300 Last Close

Volume Volume 136,313 vs 20-day avg 191,997 (relative volume 0.71x) ahead of this update. normal

Technical Shares at $0.83, trading below 200-day MA of $1.17 and 64.68% under the 52-week high.

Peers on Argus

Momentum scanner flags broader biotech moves: peers like AKTX up 8.37%, while RN...

1 Up 2 Down

Momentum scanner flags broader biotech moves: peers like AKTX up 8.37%, while RNTX and CVKD are down around 2–3%, indicating mixed but sector-wide activity alongside ALLR.

Previous Clinical trial Reports

5 past events · Latest: Feb 03 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 03	SCLC trial enrollment	Positive	-8.1%	VA-funded SCLC combo trial opened for enrollment at 11 sites.
Sep 22	Phase 2 OS data	Positive	+15.6%	Phase 2 data showed median overall survival surpassing 25 months.
Aug 26	Fast Track granted	Positive	+51.9%	FDA Fast Track designation for stenoparib in advanced ovarian cancer.
Jun 27	Second patient dosed	Positive	+2.1%	Second patient dosed in new Phase 2 ovarian cancer trial.
Jun 02	First patient enrolled	Positive	+3.2%	First patient enrolled in new Phase 2 stenoparib ovarian protocol.

Pattern Detected

Clinical trial headlines have usually produced positive reactions, with one notable negative move on the prior VA SCLC enrollment news.

Recent Company History

Over the past year, Allarity has repeatedly highlighted progress for stenoparib. FDA Fast Track designation and multiple Phase 2 ovarian cancer updates in June–September 2025 drew positive reactions, including moves of 51.92% and 15.58%. The first VA-funded SCLC trial enrollment news on Feb 3, 2026 saw a -8.06% reaction, contrasting with earlier enthusiasm. Today’s dosing milestone continues the same VA SCLC trial theme, extending a sequence of clinical execution updates.

Historical Comparison

+13.0% avg move · Past clinical-trial headlines for ALLR moved the stock an average of 12.96%, with most drawing posit...

clinical trial

+13.0%

Average Historical Move clinical trial

Past clinical-trial headlines for ALLR moved the stock an average of 12.96%, with most drawing positive reactions; today’s VA SCLC dosing update extends that same trial narrative.

Clinical news has progressed from initial ovarian Phase 2 enrollment and dosing to Fast Track designation, strong survival data, and now advancement of a VA-funded SCLC combination trial.

Regulatory & Risk Context

Active S-3 Shelf · $6.0 million

Shelf Active

Active S-3 Shelf Registration 2026-02-12

$6.0 million registered capacity

An active S-3 from Feb 12, 2026 registers 255,103 resale shares from a prior private placement. The filing also references an equity line agreement that may allow sales of up to $6.0 million of stock over time, highlighting ongoing capital needs and potential dilution from future issuances.

Market Pulse Summary

This announcement advances Allarity’s VA-funded Phase 2 SCLC program by confirming first patients do...

Analysis

This announcement advances Allarity’s VA-funded Phase 2 SCLC program by confirming first patients dosed with stenoparib plus temozolomide across 11 VA sites. It reinforces the drug’s dual PARP/WNT mechanism and highlights the high unmet need in relapsed SCLC, where only about 40% receive second-line therapy and median duration is under two months. In context of prior ovarian cancer data and Fast Track status, investors may watch for safety, efficacy, and biomarker-driven responses as key next readouts.

Key Terms

parp, temozolomide, oncogenic, blood-brain barrier, +1 more

5 terms

parp medical

"a differentiated, dual PARP and WNT pathway inhibitor—today announced"

PARP is a family of enzymes that help cells detect and repair damaged DNA; think of them as cellular repair crew members that patch small breaks. It matters to investors because medicines called PARP inhibitors can block these enzymes to kill cancer cells or make other treatments work better, so clinical trials, approvals, or setbacks for PARP-targeting drugs can strongly affect the value of companies developing them.

temozolomide medical

"stenoparib and temozolomide in the VA-funded investigator-initiated Phase 2"

An oral chemotherapy drug that works by damaging the DNA of cancer cells so they can no longer grow and divide, most commonly used to treat certain brain tumors. For investors, temozolomide matters because clinical trial results, approvals, patent status, manufacturing supply and safety data can reshape a company’s drug revenue prospects and valuation—think of it as a key product in a biotech’s toolbox whose success or failure directly affects the business outlook.

oncogenic medical

"WNT/Beta Catenin oncogenic signaling pathway. It is hypothesized that this"

Oncogenic describes anything—such as a gene change, virus, or chemical—that can cause normal cells to become cancerous and form tumors. Investors should care because oncogenic findings can shape a drug or product’s safety profile, regulatory approval, liability risk and marketability; think of an oncogenic factor like a stray spark that can start a costly, hard-to-control fire in a product or clinical program.

blood-brain barrier medical

"Stenoparib’s ability to cross the blood-brain barrier adds further clinical"

A protective barrier of tightly packed cells and supporting tissue that controls what substances in the blood can enter the brain, acting like a security checkpoint that keeps out most pathogens and many drugs while allowing essential nutrients through. For investors, the barrier matters because whether a therapy can cross or safely bypass it often determines clinical success, regulatory approval and commercial potential for treatments of brain disorders.

phase 2 trial medical

"Phase 2 trial for the treatment of relapsed small cell lung cancer"

A phase 2 trial is an intermediate-stage clinical study that tests whether a new treatment works and is reasonably safe in a group of patients who have the condition it targets. Think of it as a field test of a prototype product: it checks real-world effectiveness and side effects on a modest number of users to decide whether the treatment should move to larger, definitive testing. Investors watch phase 2 results because positive outcomes can sharply increase the likelihood of regulatory approval and future sales, while failures often halt development.

AI-generated analysis. Not financial advice.

    

• 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.”

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.

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

Attachment

• Allarity Therapeutics Press Release Allarity Therapeutics Doses First Patients in VA-Funded Phase 2 Trial

FAQ

What did Allarity (ALLR) announce about the Phase 2 SCLC trial on February 18, 2026?

Allarity announced that the first patients were dosed in a VA-funded Phase 2 trial on February 18, 2026. According to the company, the study combines stenoparib with temozolomide and is enrolling across 11 VA sites nationwide.

How is the Allarity (ALLR) Phase 2 SCLC trial funded and where is it enrolling?

The trial is fully funded by the U.S. Department of Veterans Affairs through a Special Emphasis Panel on Precision Oncology. According to the company, patient recruitment is active at 11 VA medical centers across the United States.

What is stenoparib and why is Allarity (ALLR) combining it with temozolomide?

Stenoparib is a dual PARP and WNT pathway inhibitor designed to disrupt DNA repair and WNT signaling. According to the company, this may accentuate temozolomide's DNA damage while addressing WNT-associated drug resistance.

Does stenoparib have properties relevant to brain metastases in SCLC for ALLR investors?

Yes. Stenoparib is reported to cross the blood-brain barrier, which may be relevant for SCLC patients with brain metastases. According to the company, this adds clinical relevance given common brain involvement in SCLC.

What safety advantages does Allarity (ALLR) cite for stenoparib versus earlier PARP inhibitors?

Allarity reports that stenoparib has shown a favorable safety profile compared with earlier PARP inhibitors that caused dose-limiting hematologic toxicity. According to the company, this may allow more tolerable combination therapy with temozolomide.

What unmet need in relapsed SCLC does the ALLR trial aim to address?

Relapsed SCLC has limited effective options: only about 40% receive second-line therapy and median treatment lasts under two months. According to the company, the trial targets this high unmet medical need.