On May 15, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 1,995,092 of the Company’s ordinary shares originally issued in August 2025 and September 2025 having a reduced exercise price of $0.50 per share. The ordinary shares issuable upon exercise of the warrants are registered pursuant to an effective registration statement on Form S-3 (File No. 333-290074) and an effective resale registration statement on Form S-3 (No. 333-291210). The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $1 million, prior to deducting placement agent fees and estimated offering expenses. The offering is expected to close on or about May 18, 2026, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering as working capital for general corporate purposes.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered Series C warrants to purchase up to 2,045,000 of the Company’s ordinary shares and new unregistered Series D warrants to purchase up to 1,945,184 of the Company’s ordinary shares. The new warrants will have an exercise price of $0.50 per share and will be exercisable upon the effective date of shareholder approval of the issuance of the ordinary shares issuable upon exercise of the new warrants. The Series C new warrants will expire five years after the later of (i) the date of shareholder approval and (ii) the effective date of the Resale Registration Statement (as defined below) and the Series D new warrants will expire twenty-four months after the later of (x) the date of shareholder approval and (y) the effective date of the Resale Registration Statement.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act") and, along with the ordinary shares issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the ordinary shares issuable upon exercise of the new warrants (the "Resale Registration Statement").

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Silexion Therapeutics, MAY 15, 2026, View Source [SID1234665802])

On May 15, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported the publication of Phase 1b data evaluating botensilimab (BOT), an Fc-enhanced anti-CTLA-4 antibody, in combination with balstilimab (BAL), an anti-PD-1 antibody, in patients with treatment-refractory hepatocellular carcinoma (HCC) who had progressed following prior immunotherapy. The manuscript, titled "A phase 1b study of botensilimab and balstilimab in treatment-refractory hepatocellular carcinoma," was published in Liver Cancer and is available at DOI: 10.1159/000551630.

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The publication reports results from an expansion cohort of the Phase 1b C-800-01 study in 19 patients with HCC who had progressed on or after prior immunotherapy. The cohort represents a difficult-to-treat population for which prospective data remain limited, including 47% of patients with albumin-bilirubin (ALBI) grade 2 liver function, a marker of poorer liver reserve and prognosis in HCC. In published HCC studies, ALBI grade 2 liver function has been linked to a 4- to 10-month decrement in median overall survival compared with ALBI grade 1, underscoring the poor prognosis and reduced responsiveness typically observed in this population.i

Among 18 efficacy-evaluable patients, BOT+BAL demonstrated an objective response rate (ORR) of 17%, including one complete response and two partial responses. The 18-week clinical benefit rate (CBR) was 50%. Median duration of response (mDOR) was not reached, median progression-free survival (mPFS) was 4.4 months, and median overall survival (mOS) was 12.3 months. All patients had received prior anti-PD-(L)1 therapy, 68% had received prior tyrosine kinase inhibitors, and 58% had received prior atezolizumab/bevacizumab. One patient experienced stable disease for 66 weeks, supporting the conclusion that benefit with BOT+BAL was not confined to RECIST response alone.

Treatment options after immune checkpoint inhibitor (ICI) therapy in advanced HCC remain limited, and available systemic therapies have generally shown modest activity. Published studies evaluating lenvatinib, cabozantinib and regorafenib after ICI-based therapy have reported objective response rates of 6–14%, median progression-free survival of approximately 4–5 months and median overall survival of ≤10.5 months.ii The BOT+BAL results therefore, provide early prospective evidence of activity in a post-ICI HCC population that included patients with adverse prognostic features often underrepresented in later-line studies.

"This publication adds to a consistent body of clinical evidence showing BOT plus BAL activity across difficult-to-treat, late-line solid tumors," said Steven O’Day, MD, Chief Medical Officer of Agenus. "In HCC, where tumor biology and underlying liver function both shape treatment outcomes, these data further support the rationale for botensilimab’s Fc-enhanced CTLA-4 design and its potential to drive immune activity in settings where conventional checkpoint approaches have had limited impact."

"Patients with advanced HCC who progress after immunotherapy have limited treatment options, and outcomes can be especially poor when liver function is compromised," said Anthony B. El-Khoueiry, MD, Chief of Section of Developmental Therapeutics and Associate Director for Clinical Research at USC Norris Comprehensive Cancer Center, part of Keck Medicine of USC, and principal investigator of the study. "In this exploratory cohort, seeing objective responses, prolonged disease control and a median overall survival of 12.3 months is encouraging and supports continued study of BOT plus BAL in this post-immunotherapy setting."

The safety profile of BOT+BAL in the HCC cohort was consistent with prior reports across the broader Phase 1b program. There were no treatment-related deaths and no new class safety signals. Immune-mediated treatment-related adverse events occurred in 68% of patients, with grade 3 events in 37%. The most common immune-mediated treatment-related adverse events were diarrhea/colitis, hepatitis and dermatologic events. No grade 4 or higher immune-mediated treatment-related adverse events were reported. All immune-mediated hepatitis events resolved to grade 1 or lower.

HCC is the most common form of liver cancer and is often diagnosed at an advanced stage. Immune checkpoint inhibitor combinations have improved outcomes in the frontline setting, but patients who progress after immunotherapy have limited prospective evidence to guide subsequent treatment. In the published manuscript, the authors concluded that BOT+BAL demonstrated promising efficacy and manageable safety in previously treated HCC, including patients who progressed after frontline immunotherapy, and that these findings warrant further investigation.

About the C-800-01 Study

C-800-01 (NCT03860272) is an open-label, multicenter Phase 1b clinical trial evaluating botensilimab in combination with or without balstilimab in patients with advanced solid tumors. The trial enrolled over 400 patients with refractory disease and included tumor types with limited or no responsiveness to prior checkpoint inhibitors.

The HCC expansion cohort enrolled 19 patients between March 2021 and September 2023 across six U.S. sites. Patients received botensilimab at 1 mg/kg or 2 mg/kg once every six weeks plus balstilimab 3 mg/kg once every two weeks. The safety analysis included all 19 patients who received at least one dose of study drug, and the efficacy-evaluable analysis included 18 patients with at least one post-baseline imaging scan.

(Press release, Agenus, MAY 15, 2026, View Source [SID1234665787])

On May 15, 2026 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager TriKE platform, reported first quarter 2026 financial results for the period ended March 31, 2026.

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"With the initiation of our GTB-5550 Phase 1 trial, we have now advanced three TriKE candidates into the clinic, a significant milestone that underscores the continued momentum of our pipeline," said Michael Breen, Executive Chairman and Chief Executive Officer. "GTB-3650 has demonstrated an excellent safety profile thus far, and we look forward to continuing enrollment progress. With sufficient cash runway through Q4 2026, we look forward to providing updates on both programs in the second half of 2026."

GTB-3650 TriKE for CD33 positive leukemias

The ongoing Phase 1 dose escalation study is evaluating GTB-3650 for relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. Enrollment is ongoing, with Cohort 4 enrollment now complete and a total of 8 patients treated across the first four cohorts; the Company expects to provide continued progress updates throughout 2026. Dose escalation may continue up to Cohort 7 as necessary with the potential to evaluate GTB-3650 in a total of 14 patients (two patients per cohort). GTB-3650 is dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity.

GTB-5550 TriKE for B7H3 positive solid tumor cancers

The ongoing Phase 1 trial with GTB-5550 is the first nanobody TriKE tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial is focused primarily on enrolling prostate cancer patients and will evaluate up to 6 dose levels to identify the maximum tolerated dose (MTD). After the dose escalation phase, the Phase 1b expansion component will enroll patients with up to 7 different tumor types (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its safety, tolerability and preliminary anti-tumor activity.

GTB-5550 will be administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days during Week 1 and Week 2 followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration. Subsequent cycles receive treatment three times weekly for 2 weeks followed by 2 weeks of no treatment. A minimum of 2 cycles is planned, and patient-appropriate disease reassessment is performed after 2 cycles and every 8-12 weeks thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months to determine progression free survival (PFS) and overall survival (OS). More details can be found on clinicaltrials.gov with the identifier: NCT07541573.

First Quarter Ended March 31, 2026 Financial Summary

Cash Position: The Company had cash and cash equivalents of approximately $9 million as of March 31, 2026, which is anticipated to be sufficient to fund the Company’s operations through the fourth quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were approximately $400,000 compared to $1.1 million for the same comparable quarter of 2025. The $700,000 decrease was primarily due to a reduction in production costs. R&D expenses primarily relate to the Company’s continued licensing, development, production, and clinical trials of its most advanced TriKE product candidates GTB-3650 and GTB-5550 along with the progression on other promising product candidates.

Selling, General and Administrative (SG&A) Expenses (Excluding Stock Compensation): SG&A expenses for the second quarter of 2026 were approximately $2.4 million compared to $800,000 for the same comparable quarter of 2025. The $1.6 million increase was primarily due to an increase in marketing expenses, and to a lesser extent, legal fees.

Loss from Operations: The Company reported a loss from operations for the second quarter of 2026 of approximately $2.8 million compared to $1.9 million for the same comparable quarter of 2025. The 900,000 increase was primarily due to $1.6 million increase in SG&A (as described above).

Net Loss: The Company reported a net loss of approximately $2.8 million for the second quarter of 2026, compared to $800,000 for same comparable quarter of 2025. The $2 million increase consisted primarily of a $1.6 million increase in SG&A (as described above), and a decrease in non-recurring other income of approximately $1.1 million.

(Press release, GT Biopharma, MAY 15, 2026, View Source [SID1234665803])

On May 15, 2026 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported business and financial results for the fiscal second quarter ended March 31, 2026, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR).

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"The first half of fiscal 2026 demonstrated meaningful commercial progress at our majority-owned subsidiary Citius Oncology. In the four months of commercial sales since the December 2025 launch of LYMPHIR, Citius Oncology generated $5.6 million in net revenue at approximately 80% gross margins, advanced 83% of target accounts to formulary inclusion or active review, and secured payer coverage representing near 100% of covered commercial lives with no reimbursement denials reported to date. Importantly, major academic centers have begun to transition patients to local community infusion centers for treatment, a critical next phase of commercial scaling. These results reflect our efforts to build a durable patient access foundation upon which to drive growth," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharma and Citius Oncology.

"Subsequent to quarter end, Citius Oncology secured up to $36.5 million in combined debt and equity financing through its senior secured credit facility with Avenue Capital and the exercise of outstanding warrants, complemented by Citius Pharma’s $5 million registered direct offering. Together, these proceeds are expected to fund Citius Pharma’s activities as well as the completion of the LYMPHIR commercial field force buildout by mid-summer. This will support expanded physician engagement and broader market penetration, positioning Citius Oncology to accelerate growth as the launch matures. We believe Citius Oncology maintains sufficient inventory to support anticipated commercial demand, as well as additional demand outside the U.S., as we begin to see orders for product through our global distribution partners."

"Moreover, we are encouraged by positive preliminary topline Phase 1 data from two investigator-initiated combination studies, with pembrolizumab and prior to CAR-T therapy, which reinforce LYMPHIR’s potential as a platform asset in combination regimens. At the Citius Pharma level, we also remain focused on advancing Mino-Lok and Halo-Lido with the FDA and on disciplined execution of our mission to bring first-in-class therapies to patients," concluded Mazur.

Fiscal Second Quarter 2026 Business Highlights and Subsequent Developments

● Reported key commercial metrics of LYMPHIR launch:

○ 83% of target accounts had added or were actively progressing LYMPHIR through formulary review;

○ Secured near 100% of covered commercial lives; no reimbursement denials or prior authorization barriers reported;

○ Initial accounts placing repeat orders;

○ Patients beginning to transition from larger academic cancer centers to community infusion centers;

● Announced initial shipment of LYMPHIR to Europe on April 29, 2026 through Uniphar, a leading international healthcare services company, with LYMPHIR being made available to eligible patients through Named Patient Programs (NPPs) in accordance with local regulations across 19 markets in Southern Europe, the Middle East, and additional European territories;

● Announced positive topline results from two investigator-initiated Phase 1 studies, including:

○ LYMPHIR in combination with pembrolizumab in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies;

○ LYMPHIR administered prior to commercial CD19-directed CAR-T therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with positive topline safety and efficacy results; and,

● Continued FDA engagement on Mino-Lok, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and on Halo-Lido (CITI-002), a topical formulation for hemorrhoids.

Fiscal Second Quarter 2026 Financial Highlights and Subsequent Events

● Cash and cash equivalents of $4.6 million as of March 31, 2026;

● Citius Pharma closed a $5 million registered direct offering in April 2026;

● Citius Oncology secured up to $36.5 million in financing subsequent to quarter end, consisting of:

○ $11.5 million in gross proceeds received May 5, 2026 from the exercise of certain outstanding warrants;

○ a loan agreement of up to $25 million from Avenue Capital Group, with $10 million in gross proceeds funded at close on May 6, 2026, and up to $15 million available in subsequent tranches pending certain revenue and liquidity milestones; and,

● Citius Pharma and Citius Oncology collectively expect to have sufficient funds to continue operations through November 2026;

● Net product revenues of $1.7 million for the three months ended March 31, 2026, compared to no revenue in the three months ended March 31, 2025, and $5.6 million for the six months ended March 31, 2026, compared to no revenue in the six months ended March 31, 2025; quarter over quarter decline reflects larger initial orders from specialty distributors at launch in the first quarter;

● Gross profit of $1.3 million for the three months ended March 31, 2026, and $4.5 million for the six months ended March 31, 2026; approximately 80% in both periods, reflecting continued commercial progress since the December 2025 launch of LYMPHIR;

● R&D expenses of $1.6 million for the three months ended March 31, 2026, compared to $3.8 million for the three months ended March 31, 2025; and $3.2 million for the six months ended March 31, 2026, compared to $5.9 million for the six months ended March 31, 2025. The decrease in both periods primarily reflects reduced clinical development activity, as the prior-year periods included costs for a pre-license inspection batch of LYMPHIR previously manufactured;

● G&A expenses of $26.4 million for the three months ended March 31, 2026, compared to $4.8 million for the three months ended March 31, 2025, primarily driven by a $19.7 million one-time CMO contract cancellation charge. G&A expenses were $32.1 million for the six months ended March 31, 2026, compared to $10.2 million for the six months ended March 31, 2025;

● Stock-based compensation expense was $3.8 million for the three months ended March 31, 2026, compared to $2.7 million for the three months ended March 31, 2025. For the six months ended March 31, 2026, stock-based compensation was $8.1 million, compared to $5.2 million for the six months ended March 31, 2025;

● Recognized a gain of $3.8 million from the sale of New Jersey state net operating losses under the New Jersey Technology Business Tax Certificate Transfer Program; and,

● Net loss applicable to common stockholders of $21.2 million, or $(0.95) per share, for the three months ended March 31, 2026, compared to $10.9 million, or $(1.27) per share, for the three months ended March 31, 2025; and $29.5 million, or $(1.34) per share, for the six months ended March 31, 2026, compared to $20.7 million, or $(2.58) per share, for the six months ended March 31, 2025.

(Press release, Citius Pharmaceuticals, MAY 15, 2026, View Source [SID1234665768])

On May 15, 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 financial results and provided an update on operational highlights for the first quarter ended March 31, 2026.

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"Q1 2026 was an especially exciting period for Allarity. While we continue to accelerate stenoparib clinical development in advanced ovarian cancer, we have also begun to expand the reach for stenoparib into new cancer indications. Indeed, in Q1, we started enrolling relapsed small cell lung cancer patients onto the VA-funded trial combining stenoparib with temozolomide. This trial may help establish stenoparib as the combination agent of choice in the PARP inhibitor class. Moreover, we reported new preclinical data suggesting that stenoparib’s unique mechanism of action may make it an attractive therapy. And, we continued to strengthen the DRP companion diagnostic strategy to help identify the patients most likely to benefit from stenoparib. Critically important, we were also notified that one of our critical U.S. patent applications has been allowed, expanding the time horizon for stenoparib’s exclusivity," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics.

"Financially, we also excelled, ending the quarter with a significant cash position and a P&L profile consistent with the prior-year period. Net loss per share was lower compared with the prior-year period, and separately, we reduced our outstanding share count during the quarter through our repurchase program. We believe this combination of clinical and preclinical progress, a Notice of Allowance for new intellectual property and financial discipline solidifies the strongest position Allarity has ever had," Mr. Jensen continued.

Clinical and Drug Development Progress

Stenoparib Phase 3-ready drug production campaign is on track for third-quarter completion. Subsequent to quarter-end, Allarity announced that its active pharmaceutical ingredient manufacturing (API) campaign for stenoparib is progressing in line with the planned timeline for completion in the third quarter of 2026. No additional cash outlays for this API manufacturing campaign are anticipated.
Stenoparib DRP companion diagnostic received USPTO Notice of Allowance: Subsequent to quarter-end, the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for Allarity’s patent application covering the Company’s DRP companion diagnostic specific to stenoparib. The allowed application, if issued as a patent, is expected to extend exclusivity at least another 11 years for stenoparib when used in concert with the DRP as a companion diagnostic.
AACR 2026 data on DRP findings in ovarian cancer: Subsequent to quarter-end, Allarity presented clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 (AACR 2026) demonstrating that the highest stenoparib DRP scores were associated with the greatest overall survival in patients treated with stenoparib, reinforcing the potential value of DRP-based patient selection.
AACR 2026 data indicated stenoparib’s potential in colorectal cancer: Allarity also presented new findings demonstrating stenoparib’s ability to modulate the WNT/β-catenin signaling pathway and inhibit the growth of human colorectal cancer cell lines at clinically relevant concentrations.
VA-funded Phase 2 lung cancer trial opened for enrollment and initiated patient dosing: During the first quarter, Allarity announced that enrollment had opened and the first patients had been dosed in its collaborative investigator-initiated Phase 2 trial with the U.S. Department of Veterans Affairs (VA) evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer. The trial, which represents the first clinical evaluation of stenoparib in combination with another anti-cancer agent, is fully funded through the VA’s Special Emphasis Panel on Precision Oncology and is open for enrollment across 11 VA medical centers throughout the United States.
Ovarian cancer program continued under FDA Fast Track designation: Allarity continued enrollment in its Phase 2 clinical trial protocol evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The amended protocol is designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum-resistant patients and to accelerate the clinical development of stenoparib toward FDA approval.
Corporate and Strategic Developments

Closed $20 million promissory note financing to strengthen the Company’s financial position. During the first quarter, Allarity also secured a $6 million equity line of credit to support the continued advancement of stenoparib.
Reduced outstanding share count during the quarter while decreasing the net loss per share, reflecting the Company’s continued financial discipline and operational execution.
First Quarter 2026 Financial Highlights
Results of Operations for the Three Months Ended March 31, 2026

Cash Position: As of March 31, 2026, cash and restricted cash totaled $29.8 million, compared to total cash and restricted cash of $27.7 million at March 31, 2025.

Prepaid Expenses: Prepaid expenses increased to $3.5 million at March 31, 2026, compared to $2.1 million at December 31, 2025, primarily reflecting payments related to stenoparib API manufacturing activities supporting potential pivotal-stage development.

R&D Expenses: Research and Development (R&D) expenses were $1.3 million for the quarter ended March 31, 2026, compared to $1.4 million for the quarter ended March 31, 2025.

G&A Expenses: General and Administrative (G&A) expenses were $1.4 million for the quarter ended March 31, 2026, compared to $1.6 million for the quarter ended March 31, 2025.

Net Loss: Net loss attributable to common stockholders was $2.75 million for the quarter ended March 31, 2026, compared to $2.73 million for the quarter ended March 31, 2025. Net loss per common share was $0.17 for the quarter ended March 31, 2026, compared to $0.25 for the quarter ended March 31, 2025.

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 the AACR (Free AACR Whitepaper) special conference on advances in ovarian cancer in September 2025. 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 in the summer of 2025. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple VA sites.

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, MAY 15, 2026, View Source [SID1234665788])