On May 15, 2026 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) ("Oncotelic" or the "Company"), a clinical-stage biotechnology company focused on oncology, AI-enabled drug development, and advanced drug delivery platforms, reported financial results for the quarter ended March 31, 2026 through its Quarterly Report on Form 10-Q, and is providing a corporate update highlighting progress across its therapeutic and platform initiatives.

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"We believe the first quarter of 2026 continues to provide validation for the strategic value of our diversified biotechnology platform," said Dr. Vuong Trieu, CEO of Oncotelic. "During the quarter, we continued advancing our oncology and AI-enabled development initiatives while maintaining the previously established fair value assessment of our GMP Bio joint venture interest as disclosed in our U.S. Securities and Exchange Commission ("SEC") filing."

Recent Operational Highlights

Continued advancement of the Company’s deciparticle-based oncology programs through its Sapu Nano joint venture, including ongoing development activities related to Sapu003 (IV everolimus) and Sapu006 (IV docetaxel).
Continued expansion of the Company’s AI-enabled biomedical development initiatives, including integration of large language model and semantic analysis capabilities designed to support biomarker identification, translational analysis, and regulatory workflow enhancement.
Completion of additional strategic development activities related to the Company’s nose-to-brain delivery platform and associated CNS-focused programs.
Ongoing development of the GMP Bio manufacturing and development infrastructure intended to support clinical-stage and commercial-scale pharmaceutical manufacturing capabilities.

Financial Highlights

As disclosed in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2026 and 2025, filed with the SEC on May 14, 2026, the Company maintained the fair value of its 45% ownership interest in GMP Biotechnology Limited, our joint venture with Dragon Overseas Limited at approximately $388 million as of March 31, 2026.

The fair value of the Company’s ownership was supported by an independent third-party valuation analysis performed in accordance with ASC 820 fair value accounting guidance utilizing a combination of discounted cash flow and market-based methodologies for the year ended December 31, 2026. Management concluded that no material events occurred during the quarter requiring adjustment to the previously established fair value or valuation framework.

Management Commentary

Mr. Amit Shah, CFO of Oncotelic said, "We believe our integrated strategy combining oncology therapeutics, advanced drug delivery technologies, AI-enabled development tools, and manufacturing infrastructure creates multiple potential value drivers, directly and through GMP Bio, across the organization. We remain focused on advancing our programs in a capital-efficient manner while pursuing strategic opportunities that may enhance long-term shareholder value."

(Press release, Oncotelic, MAY 15, 2026, View Source [SID1234665792])

On May 15, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported an update on corporate progress and reported third quarter financial results as of March 31, 2026 (Year end June 30).

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Corporate and R&D Highlights

Executes Service Agreement with FyoniBio GmbH to Establish & Validate Pharmacokinetics Assay for Phase 1b First-In-Human Study

Management has executed a service agreement with FyoniBio GmbH (formerly Glycotope, est. 2010), a German Contract Development Organization (CDO) based in Berlin for establishing and validating a liquid chromatography-mass spectrometry (LC-MS) based pharmacokinetics (PK) assay. The objective is to quantify the Company’s lead asset, PRP, consisting of two proenzymes trypsinogen and chymotrypsinogen, as well as their activated enzyme forms trypsin and chymotrypsin from human serum during the Phase 1b, First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors.

Executes Multi-Yr, Anti-Aging & Cancer Research Collaboration with the Universities of Jaén and Granada, Spain

A multi-year Joint Research Collaboration Agreement has been established with the Universities of Jaén (UJA) and Granada (UGR), Spain. The collaboration involves the evaluation of a senescence-modulating (i.e., anti-aging) compound to mitigate senescence and to complete experiments to further support the claims of recently filed fibrosis and cancer related patent applications, requested by Propanc Biopharma Inc. to the research group "Biological Technologies of The University of Jaén" and UGR’s Research Group, "Advanced Therapies: Differentiation, Regeneration and Cancer."

Corporate and Financial Updates

Propanc entered into a private placement agreement for up to $100 million to accelerate clinical development. The Company received an initial $1,000,000 investment upon issuance of 100 shares of Series C Convertible Preferred Stock. As of March 31st, a further $1,000,000 investment was received upon exercise of 100 shares of Series C Convertible Preferred Stock.

Q3 Financial Summary (Quarter Ended March 31, 2026)

Total assets: $14.33 million

Total liabilities reduced by $2.10 million

Convertible notes reduced to $55,000 (from $538,000)

Net cash from financing activities: $4.47 million

Quarter-end cash: $443,702

$0.5 million tranche from the Series C facility subsequently received
The Company expects the financing facility to continually support planned R&D activities, including advancement of PRP and Rec-PRP.

Management Commentary

"We are entering a pivotal phase of development for the Company’s lead asset, PRP, which is progressing to a world first, Phase 1b, First-In-Human study, in 30 – 40 advanced cancer patients suffering from solid tumors. Execution of an agreement with Fyoni Bio will facilitate method development and validation of the pharmacokinetics method in preparation for the pivotal clinical study. In addition, management is engaging with CDMOs (Contract Development and Manufacturing Organizations) for the GMP manufacture of PRP for supply of the finished drug product, CROs (Clinical Research Organizations) to discuss management of future clinical trial operations, as well as preparing regulatory documentation for the Clinical Trial Application targeting submission later this year," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "Additionally, our multi-year research agreement with the Universities of Jaén and Granada will continue to support, strengthen and grow our intellectual property around the use of proenzymes not just in cancer, but also focusing on cell rejuvenation to overcome age-related, chronic diseases, such as fibrosis. I am confident we are on the right path to execute a rapid transformation of our Company to clinical stage for a range of incurable diseases which can offer renewed hope for patients."

(Press release, Propanc, MAY 15, 2026, View Source [SID1234665791])

On May 15, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, reported new results from extended follow-up of its randomized, double-blind, placebo-controlled pivotal phase 3 trial of aglatimagene besadenovec (aglatimagene or CAN-2409) in intermediate- to high-risk localized prostate cancer. These findings demonstrate consistent clinical benefit across multiple exploratory endpoints, reinforcing the positive topline data announced in December 2024 after an additional 20 months of follow-up, with a cutoff date of March 15, 2026.

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The data were presented by Mark G. Garzotto, M.D., Professor of Urology and Radiation Medicine at Oregon Health & Science University, during the "Practice-changing, Paradigm-shifting Clinical Trials in Urology" oral plenary session at the American Urological Association (AUA) 2026 Annual Meeting in Washington, D.C.

Key Highlights from AUA 2026 Presentation:

Among the 745 patients enrolled in the randomized, double-blind, placebo-controlled trial, the aglatimagene arm exhibited a 39% improvement in prostate cancer-specific disease-free survival (PCa-specific DFS) compared to placebo (hazard ratio [HR] 0.61; 95% confidence interval [CI]: 0.44, 0.85; p=0.0031) after a median follow-up of 58 months (data as of March 15, 2026). Two prostate cancer-specific deaths occurred (1 in each arm) after median follow-up of less than 10 years.

We observed consistently favorable trends in the ITT population across all secondary and exploratory endpoints, including time to biochemical failure (TTBF; HR 0.72, CI 0.40,1.31), time to metastasis (TTM; HR 0.58, CI 0.21, 1.59), rate of metastasis [(1.6% (8/496) vs. 2.8% (7/249)], and time to salvage anti-cancer therapy (time to new treatment (TTNT) HR 0.72, CI 0.39, 1.31), when comparing the aglatimagene arm with placebo on top of standard-of-care radiotherapy.

Within the intermediate-risk subgroup (635 patients, 85% of the ITT population), the aglatimagene arm demonstrated 41% improvement in PCa-specific DFS (HR 0.59, 95% CI 0.41, 0.84, p=0.0034) relative to placebo. In addition, descriptive analyses showed 52% improvement in TTBF (HR 0.48, CI 0.22, 1.03), 90% improvement in TTM (HR 0.1, CI 0.01, 0.85), lower rate of metastatic disease [0.24% (1/422) vs. 2.35% (5/213)], and 49% improvement in TTNT (HR 0.51, CI 0.24, 1.1), when comparing the aglatimagene arm with the placebo arm.

In December 2024, we reported that aglatimagene significantly improved the rate of pathological complete response in 2-year biopsies compared with placebo, suggesting the cancer had been eradicated at a microscopic level.1 Previously published work has shown that histologic changes precede clinical evidence of recurrence and that prostate biopsies, positive for cancer cells ≥ 2 years after radiotherapy, are predictive of subsequent clinically meaningful outcomes, including biochemical failure and development of metastases.2 While the number of events for biochemical failure and development of metastases presented at AUA is, as expected, still too small to achieve statistical significance for most outcomes, the observed trends are consistent and in line with this published literature, supporting the potentially long-term clinical benefit of aglatimagene. We will continue to monitor the patients over time.

"After prolonged follow-up, these data further demonstrated that aglatimagene delivered a statistically significant and clinically meaningful improvement in prostate cancer–specific disease-free survival, with a 39% reduction in the risk of recurrence," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics. "Importantly, we are seeing consistent, favorable trends across multiple clinically relevant secondary and exploratory endpoints, including time to biochemical failure, time to metastasis, and need for subsequent anti-cancer therapy. These findings, combined with earlier evidence of increased pathological complete response at two years, reinforce our confidence that aglatimagene has the potential to deliver durable control of both local and systemic disease and to meaningfully reduce the risk of recurrence for patients undergoing radiotherapy with curative intent for localized prostate cancer. We will continue to follow patients as these data mature, with the expectation that the long-term clinical benefit may become even more apparent over time."

"I am grateful for the opportunity to have presented these data at the AUA Annual Meeting on behalf of all of our study investigators," said Mark G. Garzotto, M.D. "What is particularly compelling is the clear translation of biologic activity into meaningful clinical benefit: patients are experiencing longer periods free from recurrence and the need for additional therapy. These results move us closer to what matters most to patients—living free from cancer—and underscore the potential of aglatimagene to potentially redefine the standard-of-care in localized prostate cancer."

Current standard-of-care radiation therapy for intermediate- to-high-risk localized prostate cancer has remained largely unchanged, with a significant unmet medical need, as approximately 30% of patients experience disease recurrence within 10 years. If approved, aglatimagene immunotherapy could represent the first new therapy for men with localized prostate cancer in over 20 years. Candel continues to plan to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration in the fourth quarter of 2026. Details from the presentation are available on the Candel website at View Source

Conference Call and Webcast Replay:

Candel hosted a webcast and conference call on Friday, May 15, 2026, which discussed the Company’s extended follow-up data from the phase 3 clinical trial of aglatimagene in patients with intermediate- to high-risk localized prostate cancer.

The replay of the webcast can be accessed here and on the Candel website at View Source under Events & Presentations, in the Investors section of the website.

About aglatimagene besadenovec (CAN-2409)

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use.

(Press release, Candel Therapeutics, MAY 15, 2026, View Source [SID1234665790])

On May 15, 2026 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, reported financial results for the first quarter ended March 31, 2026 and provides an overview of recent and upcoming business highlights.

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"Our team remains focused on our two highest-priority 2026 goals, CNSide commercial scale-up and REYOBIQ pivotal-trial readiness," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "We continue to add payers for CNSide, including a fourth national payer, expanding coverage to approximately 81 million covered lives, as well as receiving a unique PLA code for billing and successfully enrolling CNSide with Medicare. Concurrently, we secured FDA Orphan Drug Designation for REYOBIQ in pediatric malignant gliomas, while progressing on the ReSPECT-LM clinical trial. We enter the second quarter with the resources and focus to continue to deliver on our 2026 milestones."

Q1 2026 AND RECENT HIGHLIGHTS

Corporate

Completed an upsized public offering generating $15 million in gross proceeds, increasing our available cash balance, and supporting CNSide commercialization and advancement of two ongoing Phase 2 clinical programs
Strengthened the leadership team with three senior appointments to support clinical development, market access, and research and development execution: Eric J. Daniels, M.D., MBA, joined as Chief Development Officer; Randy H. Goodman, Ph.D., M.H.A., joined as Vice President, Value Strategy and Health Economics & Outcomes Research; and Colby Squire joined as Vice President of Research & Development
REYOBIQ Development

Granted U.S. FDA Orphan Drug Designation for REYOBIQ (rhenium Re186 obisbemeda) for the treatment of pediatric malignant gliomas on April 8, 2026; the FDA broadened the designation beyond the Company’s original request to include progressive pediatric ependymoma
Secured American Medical Association Category III CPT reimbursement code for convection-enhanced delivery with REYOBIQ, unlocking market access and growth potential of REYOBIQ therapy in recurrent glioblastoma and pediatric brain cancer
Added SpectronRx as a second GMP manufacturing site for REYOBIQ supply, supporting commercial manufacturing readiness and supply chain resiliency for the ReSPECT-LM and ReSPECT-GBM trials
Reported on the Type B meeting with the FDA, with constructive feedback supporting the development plan for REYOBIQ in patients with leptomeningeal metastases (LM) and informing the path toward a pivotal trial framework
CNSide CSF Assay Platform

Received a unique PLA code for billing and successfully enrolled CNSide with Medicare to further advance reimbursement for the CNSide assay
Announced new payer coverage agreements, most recently with Blue Shield of California, effective April 2026, increasing total U.S. covered lives to approximately 81 million. This is the fourth national or regional payer added to a list that includes United Healthcare, Humana, and Highmark which were previously announced
Further scaled CNSide Diagnostics operations and capacity, including expansion of the field-based teams, customer service, and laboratory operations functions
FIRST QUARTER 2026 FINANCIAL RESULTS

Cash and investments balance was $15.1 million as of March 31, 2026, compared to $8.6 million as of December 31, 2025; the change reflects approximately $15 million in gross proceeds from the upsized January 2026 public offering, partially offset by operating expenditures during the quarter and paydown of the investor liability at December 31, 2025 of $4.5 million
Recognized $1.0 million in revenue in the first quarter of 2026, including grant revenue from CPRIT for the advancement of REYOBIQ in LM and CNSide diagnostic billings, compared to $1.1 million in the first quarter of 2025. CNSide commenced billing for diagnostic revenue in Q1 2026 with the amount fully reserved
Total operating loss for the first quarter of 2026 was $7.1 million, compared to $3.5 million for the first quarter of 2025; the change primarily reflects expansion of CNSide commercial operations and continued investment in REYOBIQ Phase 2 trial execution
Net loss for the first quarter of 2026 was $6.9 million, or $1.05 per basic share, compared to $17.4 million, or $29.86 per basic share, for the first quarter of 2025 (calculated post reverse)
REAFFIRMED ANTICIPATED MILESTONES AND OUTLOOK FOR 2026
The Company is reaffirming the milestone framework and outlook provided in its full-year 2025 results.

REYOBIQ clinical program:

Define optimal dose/interval for REYOBIQ in the ReSPECT-LM Phase 2 trial
Complete enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma; data expected in Q1 2027 and conduct End of Phase meeting with FDA
Begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase 1 trial
Complete commercial manufacturing scale-up for REYOBIQ
CNSide commercial rollout:

Expand U.S. commercial payer coverage to greater than 150 million covered lives
Secure Medicare coverage pathway
Achieve greater than 1,250 annualized test orders
Launch additional CSF tumor characterization assays to expand the CNSide platform
About Leptomeningeal metastases (LM)
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off-target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, MAY 15, 2026, View Source [SID1234665789])

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])