On August 18, 2025 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Amtagvi (lifileucel), a tumor-derived autologous T cell immunotherapy (Press release, Iovance Biotherapeutics, AUG 18, 2025, View Source [SID1234655338]). Amtagvi is indicated for the treatment of adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor, and who have no satisfactory alternative treatment options.

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"This approval in Canada is our first marketing authorization outside the U.S. and marks a significant step forward for Iovance as we prepare to introduce Amtagvi in countries with a high prevalence of advanced melanoma and address substantial unmet needs in solid tumor cancers," said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. "We expect to authorize our first Canadian treatment center within the next few months, and we continue to advance our ex-U.S. strategy for Amtagvi in additional markets."

Market authorization in Canada under the NOC/c guidance was granted based on safety and efficacy results from the global, multicenter C-144-01 trial investigating Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, where applicable. The market authorization is conditional, pending the results of trials to confirm its clinical benefit.

About the C-144-01 Clinical Trial
C-144-01 is a global, multicenter Phase 2 study in which patients received treatment with lifileucel monotherapy. The study enrolled patients with metastatic melanoma who were previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation‑positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor. Efficacy was established on the basis of objective response rate (ORR), and duration of response (DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The detailed results of C-144-01 were published in the Journal for ImmunoTherapy of Cancer in 2022. A five-year analysis of C-144-01 was published in the Journal of Clinical Oncology in 2025.

Iovance is investigating Amtagvi in frontline advanced melanoma in the Phase 3 trial, TILVANCE-301 (NCT05727904), as well as in additional solid tumor types.

On August 15, 2025 The Board of Directors of Xspray Pharma AB (publ) ("Xspray", "Xspray Pharma" or the "Company") reported, by virtue of the authorization from the annual general meeting held on 13 May 2025, resolved to carry out a new issue of shares of approximately SEK 130 million, with preferential rights for the Company’s existing shareholders (the "Rights Issue") (Press release, Xspray, AUG 15, 2025, View Source [SID1234655395]). The Rights Issue could be increased with up to SEK 20 million as an over-allotment issue (the "Over-allotment Issue"). The Company has received subscription undertakings and an intention to subscribe for shares of approximately SEK 89 million from its largest shareholders and a new institutional investor (the "Institutional Investor"). Furthermore, the Company has refinanced its existing loan, whereby Fenja Capital II A/S ("Fenja", the "Lender") takes over the entire loan with an extended maturity of 18 months and an increase of the loan with SEK 25 million (the "Refinancing", and together with the Rights Issue, the "Financing"). As part of the Refinancing, the Board of Directors of Xspray will issue warrants to the Lender following the outcome of the Rights Issue. As a result of the Financing, the Company is bringing forward its interim report, which will be published today, 15 August 2025, at 08:00 CEST.

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Summary of the Rights Issue and Over-allotment Issue

The Board of Directors of Xspray has resolved to carry out a new issue of shares of approximately SEK 130 million, with preferential rights for the Company’s existing shareholders. The Rights Issue could be increased with up to SEK 20 million through the Over-allotment Issue, mainly to accommodate the external interest from the Institutional Investor but also in the Board of Directors’ sole discretion. Following allocation to the Institutional Investor, if necessary, in the Over-allotment Issue, the remaining shares in the Overallotment Issue shall be allocated to strategic and/or qualified investors.
The Financing is carried out to support the launch of Dasynoc in the U.S. market, to advance the regulatory FDA process and sales readiness for XS003-nilotinib, to finance the continued development of the project portfolio, and to secure the Company’s funding through to the expected cash flow break-even point in the second half of 2026. The Company’s capital requirements depend on several factors, including the launch date of Dasynoc, as well as market uptake.
The Rights Issue is covered to approximately 60 percent by subscription undertakings from, among others, Flerie, Ribbskottet, the Fourth AP fund, the Third AP fund, the Second AP fund and the Institutional Investor and to 8 percent by a declaration of intent to subscribe for shares from Unionen. The Institutional Investor’s commitment to subscribe for shares amounts to SEK 10 million without preferential rights in the Rights Issue. Should the Institutional Investor not receive full allocation in the Rights Issue, it shall receive sufficient allocation in the Over-allotment Issue to ensure that it receives full allocation. In total, subscription undertakings and the intention to subscribe for shares amount to approximately 68percent of the Rights Issue.
For each existing share held on the record date of 22 August 2025, one (1) subscription right is received. Ten (10) subscription rights entitle to subscription of one (1) new share, corresponding to a subscription ratio of 1:10.
The subscription price in the Rights Issue of SEK 35 per share corresponds to a discount of approximately 27 percent compared to the theoretical price (so called TERP – theoretical ex-rights price) based on the closing price of Xspray’s share on Nasdaq Stockholm on 14 August 2025.
The subscription period in the Rights Issue is expected to run from 26 August 2025 up to and including 9 September 2025.

Summary of the Refinancing

The Company’s has refinanced its existing loan of SEK 100 million, whereby Fenja takes over the entire loan previously held by both Fenja and Buntel AB. As part of the Refinancing, the maturity has been extended 18 months from the date of the Refinancing and the loan has been increased with SEK 25 million. Furthermore, the Company will issue new warrants to Fenja equaling in total 2.5 percent dilution of the shares in the Company immediately following the Rights Issue.

Xspray’s CEO Per Andersson comments: "This proposed step in our financing plan will secure our financing needs for the upcoming product launch and commercialization of Dasynoc upon FDA market approval, as well as continued development of XS003-nilotinib and other product candidates in our portfolio. I would like to again express my gratitude to the many shareholders and investors who, through their commitments in connection with the rights issue, demonstrate continued confidence in our commercialization plan."

Background and reasons
Xspray Pharma is a pharmaceutical company with multiple product candidates in clinical development. Xspray uses its patented HyNap technology to develop improved versions of marketed protein kinase inhibitors ("PKI"), known as original drugs, for the treatment of cancer. The segment is the largest in the field of oncology and drug prices are typically high.

Xspray’s technology platform is used to create a project portfolio of cancer products based on amorphous formulations (HyNap) of selected drugs where the original drug contains a poorly soluble crystalline drug substance. Xspray’s overall strategy is to apply its technology to develop and commercialize its own project portfolio consisting of carefully selected product candidates. The Company selects product candidates for further development and potential future launch by thoroughly reviewing, among other things, the original drug’s patent situation, pricing, market size, competitive landscape and improvement potential.

Xspray’s announced product candidates Dasynoc, XS003, XS008, and XS025 are being developed as improved versions of Sprycel (dasatinib), Tasigna (nilotinib), Inlyta (axitinib) and Cabometyx (cabozantinib). The Company is preparing to launch its first product candidate, Dasynoc, which could be approved by the FDA in the second half of 2025. With its first four product candidates, Xspray is targeting original drugs that together sold for USD 4.9 billion in the US alone in 2024.1 When the primary patents for the original drugs expire, the Company believes that its patented HyNap technology will enable Xspray to introduce its product candidates to the market in parallel with the originator drugs, with or without generic competition.

In August 2025, Xspray announced a licensing agreement with Handa Therapeutics, relating to a dasatinib product. This was the first licensing agreement signed by the Company. Further licensing agreements will be considered on a case-by-case basis as a complementary business model.

Use of proceeds from the Financing
The Financing is carried out to support the launch of Dasynoc in the U.S. market, to advance the regulatory FDA process and sales readiness for XS003-nilotinib, to finance the continued development of the project portfolio, and to secure the Company’s funding through to the expected cash flow break-even point in the second half of 2026. The Company’s capital requirements depend on several factors, including the launch date of Dasynoc, as well as market uptake.

Terms of the Rights Issue
The Board has resolved on the Rights Issue by virtue of the authorization from the annual general meeting held on 13 May 2025. Those who are registered as shareholders in the share register of Xspray on the record date 22 August 2025 have preferential rights to subscribe for new shares in Xspray in relation to their current shareholding in the Company. Shareholders receive one (1) subscription right for each share held in the Company. The subscription rights entitle the holder to subscribe for new shares in the Rights Issue, whereby ten (10) subscription rights entitle the shareholder the right to subscribe for one (1) new share. In addition, investors are offered the possibility to apply for subscription of shares without subscription rights.

If all of the shares in the Rights Issue are not subscribed for by virtue of subscription rights, the Board of Directors shall resolve on the allocation of shares which have not been subscribed for by virtue of subscription rights. In such case, shares shall: (i) firstly be allocated to those who have applied for subscription and subscribed for new shares by virtue of subscription rights, regardless if the subscriber was a shareholder on the record date or not, and in the event of oversubscription, in relation to the number of subscription rights each have exercised for subscription of new shares, and, to the extent that this is not possible, by drawing lots, and (ii) secondly, shares are allocated to others whom have applied for subscription of shares without exercising subscription rights, and in the event of oversubscription, in relation to the number of new shares specified in the subscription application, and, to the extent that this is not possible, by drawing lots.
The subscription price in the Rights Issue is SEK 35 per share. Provided that the Rights Issue is fully subscribed, Xspray will receive issue proceeds of approximately SEK 130 million before deduction of transaction costs. Provided that the Rights Issue is fully subscribed, the number of shares will increase by 3,713,849 shares, from 37,138,491 shares to 40,852,340 shares and the share capital will increase by SEK 3,713,849, from SEK 37,138,491 to SEK 40,852,340. Shareholders who choose not to participate in the Rights Issue will through the Rights Issue have their ownership share diluted by up to approximately 9.1 percent (based on the total maximum amount of shares after the Rights Issue but excluding any shares issued as part of the Over-allotment Issue). These shareholders may have an opportunity to compensate themselves financially for the dilution effect by selling their subscription rights received.

Full terms of the Rights Issue and information about the Company will be presented in a disclosure document in accordance with Article 1.4 db of the Regulation (EU) 2017/1129 of the European Parliament and of the Council (the "Prospectus Regulation"). The disclosure document, prepared in accordance with Annex IX to the Prospectus Regulation, is expected to be published on or around 25 August 2025.

Over-allotment Issue
In addition to the Rights Issue, the Board may resolve on the Over-allotment Issue by virtue of the authorization from the annual general meeting held on 13 May 2025 as a directed share issue. The Over-allotment Issue amounts to a maximum of SEK 20 million. In case the Over-allotment Issue is fully exercised, the total proceeds, including the Rights Issue, will amount to approximately SEK 150 million before deduction of transaction costs.

The Institutional Investor has committed to subscribe for shares without preferential rights in the Rights Issue corresponding to a total amount of SEK 10 million, without remuneration. The Over-allotment Issue will be exercised in case the Rights Issue is subscribed to such an extent that the Institutional Investor will not be allocated their full commitment of SEK 10 million in the Rights Issue. The Institutional Investor’s subscription in the Over-allotment Issue will thereby be determined by the difference between its total commitment of SEK 10 million and its actual subscription in the Rights Issue, meaning that the Institutional Investor’s total commitment within the Rights Issue and Over-allotment Issue will be SEK 10 million. The Board of Directors may also, in their sole discretion, exercise the remaining part of the Over-allotment Issue to enable additional capital contributions. Following allocation, if any, to the Institutional Investor in the Over-allotment Issue, the remaining shares in the Overallotment Issue shall be allocated to strategic and/or qualified investors. The subscription price in the Over-allotment Issue will be SEK 35 per share.

Terms of the Refinancing
The Company has refinanced its existing loan of SEK 100 million, whereby Fenja takes over the entire loan previously held by both Fenja and Buntel AB. As part of the Refinancing, the maturity has been extended 18 months from the date of the Refinancing and the loan has been increased with SEK 25 million. The loan is unsecured.

The Refinancing includes an arrangement fee of 4 percent and bears an annual interest rate at STIBOR 3M (however minimum 3 percent) plus an interest margin of 8 percent. Furthermore, the Company will issue new warrants free of charge, equaling in total 2.5 percent dilution of the shares in the Company immediately following the Rights Issue. Assuming that the Rights Issue is fully subscribed, the Company would issue 1,047,495 warrants to Fenja. The warrants can be exercised to subscribe for the equivalent number of shares in the Company from and including the day of registration of the warrants with the Swedish Companies Registration Office and up to and including 30 November 2029, at a subscription price of SEK 50 per share from registration with the Swedish Companies Registration Office up to and including 6 November 2025, as well as from and including 7 November 2025 at a subscription price of SEK 60. The warrants will not be re-calculated as a result of the Rights Issue but are otherwise subject to customary re-calculation provisions. The Board of Directors will issue the warrants by virtue of the authorization from the annual general meeting held on 13 May 2025.

Subscription undertakings and subscription intentions in the Rights Issue
Flerie, Ribbskottet, the Fourth AP fund, the Third AP fund, the Second AP fund, the Institutional Investor and other investors have undertaken to subscribe for shares corresponding to approximately 60 percent of the Rights Issue. Unionen has submitted a declaration of intent for subscription of shares in the Rights Issue, covering approximately 8 percent of the Rights Issue. The Institutional Investor’s commitment to subscribe for shares amounts to SEK 10 million without preferential rights in the Rights Issue. Should the Institutional Investor not receive full allocation in the Rights Issue, it shall receive sufficient allocation in the Over-allotment Issue to ensure that it receives full allocation. In total, these subscription undertakings and the intention represent approximately 68 percent of the Rights Issue, corresponding to approximately SEK 89 million.

The subscription undertakings are not secured by bank guarantees, blocked funds, pledging, or similar arrangements.

Lock-up undertakings
Prior to the execution of the Rights Issue, all shareholding members of the Board of Directors and senior executives of the Company have towards Zonda Partners undertaken, subject to certain customary exceptions, not to sell shares in the Company for a period of 90 days from the day after the outcome of the Rights Issue has been announced, a so-called lock-up undertaking.

Furthermore, the Company has undertaken towards Zonda Partners, subject to customary exceptions and except for the issue of warrants to the Lender, not to issue additional shares or other share-related instruments for a period of 90 days from the day after the outcome of the Rights Issue has been announced.

On August 15, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported to have published a study in Oncotarget validating the analytical and clinical performance of MI Cancer Seek (Press release, Caris Life Sciences, AUG 15, 2025, View Source [SID1234655336]). This FDA-approved assay is used as a companion diagnostic (CDx) to identify cancer patients who may benefit from targeted therapies. It includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. MI Cancer Seek is the first and only test to combine whole exome sequencing (WES) and whole transcriptome sequencing (WTS) with FDA-approved CDx indications for solid tumor profiling in both adult and pediatric patients, marking a significant advancement in precision oncology.

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The study demonstrates that MI Cancer Seek works reliably for detecting multiple variant types of high clinical significance, and that its approved medical uses follow strict laboratory standards. The assay supports eight companion diagnostic (CDx) claims, each addressing high clinical burden areas and demonstrating strong performance when compared to other FDA-approved assays, with positive and negative percent agreement ranging from 97% to 100%. MI Cancer Seek offers the added benefit of simultaneous RNA and DNA extraction from minimal tissue input compared to other tissue-based assays that may require individual testing processes for DNA and RNA and result in increased tissue requirements and potential delays.

"MI Cancer Seek provides a comprehensive molecular blueprint that saves tissue without compromising results. The study results underscore our commitment to ongoing scientific integrity and validation," said David Spetzler, MS, PhD, MBA, President of Caris. "Patients and physicians deserve this level of diligence and scientific rigor when selecting a molecular profiling assay to inform cancer treatment."

"Broad-based biomarker panels are key to improving outcomes in precision medicine, yet many patients still miss out on comprehensive molecular profiling," said George W. Sledge, Jr., MD, Caris EVP and Chief Medical Officer. "By integrating companion diagnostic tests into multi-gene panels that make the most of tissue samples, we can reduce inefficiencies and potentially help more patients access personalized therapies."

MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies, in accordance with the approved therapeutic product labeling. Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.

On August 15, 2025 Children’s Hospital of Philadelphia (CHOP), reported to have identified tiny pieces of messenger RNA that are missing in pediatric high-grade glioma tumors but not in normal brain tissues (Press release, CHOP, AUG 15, 2025, View Source [SID1234655335]). Preclinical research indicates that these missing RNA fragments can make difficult-to-treat tumors more responsive to immunotherapy. The findings were recently published in the journal Cell Reports.

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One of the biggest challenges facing cancer research is the need to find safe and effective therapies for the most aggressive types of brain tumors. Adoptive immunotherapies with CAR-T cells are promising; however, they often also target healthy cells, which share most surface proteins with cancerous cells. While this collateral damage might be tolerable in patients with certain types of blood cancer, in the brain, wiping out healthy neurons is unacceptable. This means that deep knowledge of gene expression patterns exclusive to tumor cells is critical.

A potential means of discovering new therapeutic targets for brain tumors may lie in alternative splicing, a process whereby a single gene produces multiple proteins by rearranging exons, the building blocks of messenger RNA, in different combinations. Researchers suspected that splicing in glioma cells may differ from splicing in normal brain cells, which could help devise new therapeutic interventions.

In this study, researchers found that prior RNA sequencing analyses of high-grade gliomas failed to account for some very short exons called "microexons." Deeper analysis revealed that in glioma, many of these microexons fail to be incorporated into messenger RNAs encoding important surface proteins, including the neuronal cell adhesion molecule known as NRCAM. For normal brain cells to make close contacts known as synapses, full-length NRCAM is needed, but in pediatric high-grade gliomas, two NRCAM microexons were consistently skipped, resulting in a distinct protein structure with unknown function.

When studying these microexons in more detail, the researchers found that the shortened version of NRCAM generated through microexon skipping was essential for cancer cell migration and invasion in Petri dishes and for tumor growth in a preclinical mouse model implanted with glioma cells. This makes the glioma-specific version of NRCAM an especially attractive immunotherapy target because the tumors won’t be able to shut it down easily.

"While microexons may be small, the effects they have on the overall protein structure are quite profound," said senior study author Andrei Thomas-Tikhonenko, PhD, chief of the Division of Cancer Pathobiology at CHOP and Professor of in the Department of Pathology and Laboratory Medicine at the Perelman School of Medicine of the University of Pennsylvania.

"Because the skipping of NRCAM microexons profoundly changes protein conformation, we were able to develop a mouse monoclonal antibody against the glioma-specific version of NRCAM. When mixed with glioma cells, the antibody worked like a highlighter, "painting" glioma cells and marking them for killing by T cells armed with an immune receptor for mouse antibodies."

"In addition to developing these immune receptors clinically, we are actively using our proof-of-principle experiments to design traditional CAR T cell-based immunotherapeutics that selectively target glioma cells," said first study author Priyanka Sehgal, PhD, a research scientist in the Thomas-Tikhonenko laboratory at CHOP. "This could also change the way we find new targets in other solid tumors."

The next steps for this work will be to expand preclinical research and identify a specific form of immunotherapy that could potentially be explored in a clinical trial. The researchers also noted that similar molecular mechanisms have been observed in other tumors such glioblastoma multiforme and cancers of neuroendocrine origin, which also could be targeted with NRCAM-directed immunotherapeutics.

This study was supported mainly by the CureSearch for Children’s Cancer Foundation Acceleration Initiative and also by the National Institutes of Health grants U01 CA232563, R03 CA293992, R01 HG013359, UG3 CA290451 and R01 EB026892, and NIH training grants T32 CA115299, T32 HL007150 and T32 CA009140. Additional support was provided by the National Science Foundation Graduate Research Fellowship Program, Cancer Research Society Next Generation of Scientists Award, the Children’s Brain Tumor Network,the Chad Tough Foundation, and the Mildred L. Roeckle Endowed Chair in Pathology at Children’s Hospital of Philadelphia.

On August 15, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor— reported financial results and provided an update on operational highlights for the second quarter ended June 30, 2025 (Press release, Allarity Therapeutics, AUG 15, 2025, View Source [SID1234655334]).

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"The second quarter of 2025 marked a period of strong operational execution for Allarity. Most notably, we continued to advance our lead program, stenoparib, with strong momentum in our new ovarian cancer trial protocol. In parallel, we expanded our proprietary DRP platform—both through a new commercial agreement granting a non-exclusive global license for our breast cancer DRP to a partner company, and scientifically with the development of a new DRP for the antibody therapy, daratumumab. On the financial front, we maintained a solid cash position and reduced liabilities, including a $2 million reduction in accounts payable and accrued expenses during the quarter. These developments position us well to deliver on our upcoming clinical milestones," said Thomas Jensen, CEO of Allarity Therapeutics.

"I would also like to take the opportunity to look further back, as I have now been the CEO for just over 1.5 years. I’m struck by how quickly our Company’s situation has improved. Just a year ago, we were still working to regain compliance with Nasdaq’s listing requirements. At the same time, we had just completed the cleanup of a previously complex capitalization table—which had deterred many prospective investors—and we had committed to a more focused strategy centered solely on the advancement of stenoparib. Thanks to the dedication of our team, the guidance of our board, and the support of our shareholders, we have resolved all compliance and regulatory matters, strengthened our leadership with seasoned management professionals bringing extensive life sciences experience to our board and executive team, and are successfully executing our stenoparib-focused strategy—having launched a refined monotherapy trial protocol, which is now steadily enrolling. In addition, we have advanced the Veterans Administration–funded combination trial of stenoparib and temozolomide in small cell lung cancer, which may provide valuable insights into stenoparib’s potential beyond ovarian cancer—a potential we believe could also extend to additional cancer types. Importantly, we have maintained disciplined spending. Therefore, as we present this business update—showing solid progress in the advancement of stenoparib, continued execution of our IP strategy, expansion of our DRP platform, growth in our laboratory activities, and new collaborations with R&D partners—I’m encouraged that Allarity is on the right path toward building greater interest in stenoparib, our unique DRP technology, and thereby the Company as a whole. I am deeply grateful for the trust and support from everyone who has made this progress possible."

Clinical and Drug Development Progress

Early trial enrollment momentum: First patients dosed in the new Phase 2 clinical trial protocol, reflecting strong investigator engagement. The trial focuses on recurrent, platinum-resistant or platinum-ineligible advanced ovarian cancer patients, with the goal of optimizing dose and refining patient selection to accelerate stenoparib’s path toward regulatory approval.
IBRI research collaboration: Initiated partnership with the Indiana Biosciences Research Institute to conduct advanced molecular and cellular studies clarifying the individual and combined contributions of PARP inhibition and WNT pathway modulation to stenoparib’s anti-cancer effects. This work aims to deepen mechanistic understanding, strengthen DRP-based patient selection, and potentially expand therapeutic opportunities, including in cancers such as colorectal cancer where WNT pathway activation is common.
Corporate and Strategic Developments

IP portfolio expansion: Received Australian patent acceptance notice for the Stenoparib DRP companion diagnostic. The acceptance covers 40 claims and marks a key step in Allarity’s global strategy to protect the potential international commercialization of its proprietary DRP platform alongside the clinical development of stenoparib.
Allarity Medical Laboratory growth: Signed a new licensing and laboratory services agreement with an EU-based biotech, providing access to select DRP algorithms for breast cancer and securing laboratory services revenue commitments.
DRP platform expansion: Presented first antibody therapy–specific DRP for daratumumab in multiple myeloma at AACR (Free AACR Whitepaper) 2025, further showcasing the platform’s broad applicability across numerous cancer types and drug classes, and its ability to aid in the development of personalized, targeted therapies.
Partnering outreach: Participated in Pharma Partnering Summit US (May 14–15, 2025), where CEO Thomas Jensen presented a company overview highlighting stenoparib and the DRP companion diagnostic platform, and held one-on-one partnering meetings.
Board changes: Jesper Høiland appointed to the Board of Directors, succeeding Joseph Vazzano, effective June 30, 2025. Høiland brings more than 30 years of biopharmaceutical industry experience, including senior executive roles at Ascendis Pharma and Novo Nordisk, with a proven track record in global commercialization, corporate strategy, and business development.
Executive leadership changes: Jeffrey S. Ervin appointed as Chief Financial Officer effective July 1, 2025, succeeding Alexander Epshinsky. Mr. Ervin brings extensive financial and operational leadership experience in the biotechnology and healthcare sectors, having previously served as CEO of IMAC Holdings, where he led the company through its IPO and multiple strategic growth initiatives.
Anticipated Clinical Milestones in 2025

Ovarian cancer trial progress: Continued enrollment in new Phase 2 ovarian cancer trial protocol, with initial data expected in 2026.
SCLC combination trial launch: U.S. Veterans Administration–funded Phase 2 trial of stenoparib plus temozolomide in recurrent small cell lung cancer should open for enrollment in Q3, with patient recruitment expected to begin during H2 2025.
Second Quarter 2025 Operating Results

Cash Position: As of June 30, 2025, cash and cash equivalents totaled $17.8 million. The Company implemented a share repurchase plan and used $2.6 million for a stock buyback totaling 2,455,702 shares during the quarter. The Company also reduced accounts payable and accrued expenses by $2 million during the quarter.
R&D Expenses: Research and Development (R&D) expenses for the quarter ended June 30, 2025, were $2.3 million, compared to $1.06 million for the quarter ended June 30, 2024. The expense is consistent with planned clinical advancement activities, including the launch of the new Phase 2 ovarian cancer trial.
G&A Expenses: General and Administrative (G&A) expenses for the quarter ended June 30, 2025, were $1.8 million, compared to $2.3 million for the quarter ended June 30, 2024.
Net Loss: Net loss was $2.3 million for the quarter ended June 30, 2025, compared to $1.6 million for the quarter ended June 30, 2024. For the six months ended June 30, 2025, the Company’s net loss was $5.1 million, down from $5.5 million for the six months ended June 30, 2024.
About Stenoparib
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. 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.

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.