On 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, reported 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).

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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 (Free AACR Whitepaper) 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.

(Press release, Allarity Therapeutics, FEB 18, 2026, View Source [SID1234662759])

On February 18, 2026 aTyr Pharma, Inc. (Nasdaq: ATYR), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present at the Leerink Partners Global Healthcare Conference, which is scheduled to take place March 8 – 11, 2026, in Miami, FL.

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Details of the presentation appear below:

Conference: Leerink Partners Global Healthcare Conference
Date: Wednesday, March 11, 2026
Time: 8:00am EDT
Location: Miami, FL
Format: Corporate Presentation

In addition to the presentation, company management will be available to participate in one-on-one meetings with investors who are registered attendees of the conference. A webcast of the event will be available on the Investor’s section of the company’s website at www.atyrpharma.com. Following the event, a replay of the presentation will be available on the aTyr website for at least 90 days. For more information, contact [email protected].

(Press release, aTyr Pharma, FEB 18, 2026, View Source [SID1234662758])

On February 18, 2026 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE) reported that it has acquired Faeth Therapeutics Inc. ("Faeth"), a clinical-stage biotechnology company developing multi-node therapies that target tumor metabolism and signaling. The acquisition brings Faeth’s lead asset PIKTOR, a proprietary investigational all-oral combination of serabelisib and sapanisertib that inhibits multiple nodes of the PI3K/AKT/mTOR pathway through PI3K-alpha and dual mTORC1/2 targeting, into Sensei’s pipeline.

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Concurrent with the acquisition, Sensei entered into a definitive agreement for the sale of Series B non-voting convertible preferred stock in a private placement financing, which is expected to result in gross proceeds to Sensei of approximately $200 million before deducting placement agent and other offering expenses. The financing included participation from B Group Capital, Balyasny Asset Management, Columbia Threadneedle Investments, Cormorant Asset Management, Fairmount, Logos Capital, RA Capital Management, Vivo Capital, multiple leading life sciences funds, and other institutional investors. Sensei expects to use the proceeds primarily to advance PIKTOR through key clinical milestones, including topline data from an ongoing Phase 2 trial in second-line advanced endometrial cancer, as well as the initiation of a Phase 1b trial in HR+/HER2- advanced breast cancer, both expected by year end 2026, with remaining proceeds for general corporate purposes and completion of Sensei’s ongoing Phase 1/2 trial of solnerstotug.

"The clinical data, the caliber of the scientific team, and the investor syndicate that came together for these transactions reinforce our conviction in the program," said Bob Holmen, Chairman of the Board of Directors of Sensei Biotherapeutics. "With these proceeds, we believe the company is well capitalized to execute through key clinical milestones in endometrial and breast cancer."

"In the PI3K pathway, the field has repeatedly run into the same constraint. Single-node inhibitors force a tradeoff between efficacy and tolerability," said Anand Parikh, Co-founder of Faeth Therapeutics and new Chief Operating Officer and director of Sensei. "PIKTOR is designed to change that tradeoff by inhibiting PI3K-alpha and mTORC1/2 simultaneously, and we believe we can achieve more complete pathway suppression with improved tolerability. We saw the signal in our Phase 1b, including a number of complete responses in endometrial cancer patients after multiple prior lines of therapy. This financing takes us through topline Phase 2 data in that population and advances the Phase 1b breast cancer program."

(Press release, Sensei Biotherapeutics, FEB 18, 2026, View Source [SID1234662757])

On February 18, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported that it is approaching the first unblinding of data in its pivotal Phase 2B/3 "MIRACLE" study of Annamycin in combination with cytarabine for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML), having treated 35 subjects to date with another 11 in screening or identified. Additional subjects continue to be identified by site investigators. The targeted number for the first unblinding of data is 45 subjects with the Company believing it is on track to treat the 45th subject in Q1 2026 with unblinding of data thereafter. This update is as of February 10, 2026, as treatment, identification and recruitment are ongoing.

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Additionally, the Company reports a preliminary composite complete remission (CRc) rate of 40% in the MIRACLE trial’s first 30 subjects treated and with blinded, preliminary efficacy data. This CRc rate is comprised of a complete remission (CR) rate of 30% and complete remission with partial hematological recovery (CRh) of 10%.

"The blinded efficacy rates we’re seeing in MIRACLE are exceptionally encouraging," said Walter Klemp, Chairman and CEO of Moleculin. "And, of course, this includes the control arm of cytarabine plus placebo, which suggests that the Annamycin results should be better. Even with the control arm included, these preliminary, blinded results substantially outperform historical outcomes for CR with cytarabine alone and reinforce our expectations of what Annamycin can become in the treatment of R/R AML. Of particular note is that roughly 35% of the subjects treated to date are relapsed or refractory (R/R) from a venetoclax regimen, a subject population that is generally considered among the most challenging to address with 2nd line therapies. With the first unblinding now clearly in sight, we are entering what we believe is a transformational period for the Company."

Dr. Mohamad Cherry, a prominent thought leader in hematological oncology, remarked, "Seeing blinded efficacy rates at this level in the MIRACLE trial is encouraging for the trial’s overall robustness and suggests a hopeful clinical future for Annamycin as a non-cardiotoxic anthracycline. This could mark a significant advancement in the treatment landscape for relapsed/refractory AML."

"In another encouraging sign, the subjects treated to date presented with a high degree of genetic markers that are considered predictive of poor treatment response, which makes these results even more impressive. The efficacy rates, observed across six countries to date in MIRACLE, form the basis of our optimism for our outlook in 2026," Mr. Klemp continued. "Our current blinded CR rate is 67% in excess of the historical response rates seen in two recent HiDAC trials with cytarabine alone, which were around 17-18% CR, and also 50% greater than the median CR rate used for approval of all currently prescribed therapies for second line AML patients. What’s more, when you factor in that we estimate that one third of the subjects treated so far did not receive Annamycin, we believe it is likely that Annamycin is performing at or near the impressive level we saw in our last Phase 2 trial. Coupling this with the recently released safety data from 90 total subjects in prior clinical trials demonstrating Annamycin’s lack of cardiotoxicity, we believe Annamycin has the potential to offer a new avenue for patients battling this challenging disease. We are looking forward to the upcoming significant milestone for the Company and the MIRACLE trial of the unblinding of each arm’s efficacy for the first 45 subjects."

Mr. Klemp concluded, "Given the importance of this trial and its potential to drive future partnerships and value inflection points, we know there is a great focus on the timing of data unblinding. We are committed to frequent market updates to keep investors informed as visibility on more precise timing for unblinding becomes available."

MIRACLE Trial Progress and Next Steps

The MIRACLE study (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a Phase 2B/3, global multi-center, randomized, double-blind, placebo-controlled, adaptive designed clinical trial whereby data from the 2B (Part A) portion will be combined with the Phase 3 (Part B) portion for purposes of measuring its primary efficacy endpoint. Part A of the MIRACLE trial is designed to evaluate the effectiveness of Annamycin in two dosing arms (190 mg/m2 and 230 mg/m2) in combination with cytarabine (also referred to as Ara-C) as compared to a control arm of cytarabine plus placebo. The protocol for the MIRACLE trial allows for the unblinding of preliminary primary efficacy data (Complete Remission or "CR") and safety/tolerability of the three arms at 45 subjects in Part A, in addition to the conclusion of Part A (at 90 total subjects). The first early unblinding should yield approximately 30 subjects treated with Annamycin (190 mg/m2 and 230 mg/m2) in combination with cytarabine and 15 subjects treated with just cytarabine plus placebo.

The MIRACLE trial is being offered only to AML patients who have had a single prior induction therapy (2nd line patients or 2L). 49 subjects have provided consent to participate in this important investigation; however the number of subjects who have failed to qualify has been higher than expected, in large part because of a high number of applicants attempting to qualify who had more than one prior induction therapy. The Company views this as an indication of the significant unmet medical need among R/R AML patients.

The currently enrolled subjects, including those who have been treated but have not yet been evaluated for efficacy, are from sites across seven countries, providing a diverse base of subjects. 24 sites have had site initiation visits as the Company targets at least 30 sites for Part B. The Company is focused on improving recruitment in the US as recruitment in Europe has been robust to date.

The Company expects to reach the recruitment and treatment of the first 45 subjects in the first quarter of 2026. The unblinding of the first 45 subjects with efficacy data should occur in late Q2 2026, as the data are subject to final data entry, audit and subsequent data lock. As such, these preliminary data may differ from the final locked efficacy and safety results. The second group of 45 subjects in Part A are expected to be fully recruited in the third quarter of 2026 with unblinding expected in the second half of 2026. Recruitment of the second group of 45 subjects in Part A will continue uninterrupted while the first 45 subjects with efficacy are being unblinded. Unblinding for the full 90 subjects in Part A may require more time than for the first 45 as it involves more data to support the transition from Part A to Part B.

For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756. Additionally, the clinical trial in the EU can be found on euclinicaltrials.eu and the reference identifier is 2024-518359-47-00.

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Annamycin also benefits from composition of matter patent protection through 2040 with the potential to extend that protection as far as 2045. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA.

(Press release, Moleculin, FEB 18, 2026, View Source [SID1234662756])

On February 18, 2026 Merck (NYSE: MRK), known as MSD outside of the U.S. and Canada, and Mayo Clinic, the world’s top-ranked hospital system, reported a research and development agreement to apply artificial intelligence (AI), advanced analytics and multimodal clinical data to support drug discovery and development. The agreement integrates Mayo Clinic’s Platform architecture as well as clinical and genomic datasets with Merck’s ambition to harness AI-enabled virtual cell technologies to enhance disease understanding, improve target identification and drive early development decisions.

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By leveraging Mayo Clinic Platform–which brings together data from Mayo Clinic U.S. and its international partner network in a secure environment–Merck will integrate Mayo Clinic’s clinical insights and genomic data sets, including AI and machine learning (ML)-enabled discovery spanning computational and spatial biology. The new Mayo Clinic Platform_Orchestrate program provides Merck direct access to Mayo Clinic’s world-class clinical and scientific expertise; platform data including de-identified clinical and multimodal data sets, registries and biorepositories; advanced AI tools and analytics; and the ability to scale solutions.

Under the agreement, which marks Mayo Clinic’s first strategic collaboration of this scale with a global biopharmaceutical company, Merck will leverage Mayo Clinic’s extensive multimodal data—including laboratory results, medical imaging, clinical notes and molecular data—to support validation of AI models and help translate research insights into discovery and development strategies.

"New cutting-edge technologies are enhancing our ability to innovate with the potential to bring important new therapies to patients faster. By working with Mayo Clinic, we aim to integrate high-quality clinical data and AI-enabled insights into discovery research to improve target identification and, ultimately, the probability of success for our programs," said Robert M. Davis, chairman and CEO, Merck.

"By combining Mayo Clinic Platform’s de-identified data, clinical expertise and Platform technology with Merck’s world-class research and development capabilities, we are poised to speed innovative breakthroughs to patients and redefine drug development," said Gianrico Farrugia, M.D., president and CEO, Mayo Clinic. "This collaboration represents a new present and future for healthcare—one where platform-based collaboration leads to more answers, more cures and better outcomes for patients worldwide."

The collaboration will initially focus on high-need therapeutic areas in three specialties where advanced analytics and multimodal approaches have the potential to advance progress in the development of more effective and tailored therapies:

Gastroenterology — Inflammatory bowel disease (IBD)
Dermatology — Atopic dermatitis
Neurology — Multiple sclerosis
The collaboration builds on Merck’s broader investments in AI/ML-enabled discovery, spanning computational or spatial biology, AI foundation models and real-world data, and reflects a shared focus on applying advanced technologies in ways that support disciplined, evidence-based drug development.

(Press release, Merck & Co, FEB 18, 2026, View Source [SID1234662755])