On July 31, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) (the "Company"), reported the closing of its previously announced public offering of an aggregate of 2,000,000 shares of its common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants (Press release, AIM ImmunoTech, JUL 31, 2025, View Source [SID1234654666]). The warrants have an exercise price of $4.00 per share, and were exercisable immediately upon issuance. The Class E warrants will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date. Gross proceeds, before deducting placement agent fees and offering expenses, were approximately $8.0 million.

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Maxim Group LLC acted as sole placement agent in connection with this offering.

The securities described above were being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-284443) (the "Registration Statement"), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 28, 2025. Copies of the final prospectus relating to this offering have been filed with the SEC and may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, at (212) 895-3745.

On July 31, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported financial results and updates for the second quarter ended June 30, 2025 (Press release, Agios Pharmaceuticals, JUL 31, 2025, View Source [SID1234654665]).

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"With fewer than 40 days to our PDUFA goal date, our commercial team is prepared for the potential U.S. approval of PYRUKYND for thalassemia," said Brian Goff, Chief Executive Officer, Agios. "In the second quarter, we made progress advancing our early- and mid-stage pipeline and remain on track to deliver topline results of the RISE UP Phase 3 trial for PYRUKYND in sickle cell disease by the end of the year. Collectively, our progress reflects our continued focus on delivering innovative medicines with the potential to transform the lives of those affected by rare diseases and deliver long-term shareholder value."

Second Quarter 2025 and Recent Corporate Highlights

Commercial Performance – PYRUKYND (mitapivat)

Generated $12.5 million in net revenue for the second quarter of 2025, compared to $8.6 million in the second quarter of 2024.
248 unique patients completed prescription enrollment forms, representing an increase of 6 percent over the first quarter of 2025.
142 patients are on PYRUKYND therapy, inclusive of new starts and continued therapy, representing an increase of 4 percent over the first quarter of 2025.
Entered into a distribution agreement with Avanzanite Bioscience B.V., a rapidly growing European specialty pharmaceutical company focused on rare diseases, to distribute and commercialize PYRUKYND across the European Economic Area, the United Kingdom and Switzerland.
R&D Highlights

PYRUKYND (mitapivat)
Thalassemia –
Launch preparations underway ahead of U.S. PDUFA goal date of September 7, 2025. The sNDA for PYRUKYND for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia remains under active review by the U.S. Food and Drug Administration (FDA).
Other regulatory applications remain under review by health authorities in Saudi Arabia, United Arab Emirates, and the European Union.
Sickle Cell Disease –
Topline results from RISE UP Phase 3 trial of mitapivat in sickle cell disease on track by year-end with potential U.S. commercial launch in 2026.
Tebapivat
Sickle Cell Disease –
Dosed the first patient in the Phase 2 trial investigating tebapivat in sickle cell disease. The trial is enrolling across three dose cohorts (2.5mg, 5mg, 7.5mg) and placebo and the primary endpoint will measure hemoglobin response, defined as a ≥1g/dL increase in hemoglobin concentration from week 10 to week 12, compared to baseline.
Lower-risk Myelodysplastic Syndromes (LR-MDS) –
Continue to progress patient enrollment in the Phase 2b trial for tebapivat in LR-MDS with target enrollment completion by the end of 2025.
Early Pipeline
Investigational New Drug (IND) clearance received for AG-236, an siRNA targeting TMPRSS6 intended for the treatment of polycythemia vera (PV).
Presented new data on mitapivat and tebapivat at the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Congress. A total of 14 presentations and publications, led by Agios and external collaborators, were shared, covering sickle cell disease, thalassemia, PK deficiency, and MDS.
Second Quarter 2025 Financial Results

For the quarter ended June 30, 2025, net loss was $112.0 million dollars, compared to a net loss of $96.1 million dollars for the second quarter ended June 30, 2024.

Net product revenue from sales of PYRUKYND for the second quarter of 2025 was $12.5 million, compared to $8.6 million for the second quarter of 2024.
Cost of sales for the second quarter of 2025 was $1.7 million.
Research and Development (R&D) Expenses were $91.9 million for the second quarter of 2025, compared to $77.4 million for the second quarter of 2024. The year-over-year increase was primarily attributed to a $10.0 million regulatory milestone payment to Alnylam associated with our agreement to develop and commercialize AG-236, an siRNA targeting TMPRSS6, intended for the treatment of polycythemia vera.
Selling, General and Administrative (SG&A) Expenses were $45.9 million for the second quarter of 2025 compared to $35.5 million for the second quarter of 2024. The year-over-year increase was primarily attributable to an increase in commercial-related activities, including headcount, as the company prepares for the potential approval of PYRUKYND in thalassemia.
Cash, cash equivalents and marketable securities as of June 30, 2025, were $1.3 billion compared to $1.5 billion as of December 31, 2024. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to prepare for potential PYRUKYND launches in thalassemia and sickle cell disease, advance existing programs, and opportunistically expand its pipeline through both internally and externally discovered assets.
Conference Call Information

Agios will host a conference call and live webcast today at 8:00 a.m. ET to discuss the company’s second quarter 2025 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.

On July 31, 2025 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2025 (Press release, AbbVie, JUL 31, 2025, View Source [SID1234654664]).

"AbbVie delivered another outstanding quarter with strong performance from our diversified growth platform. We also made meaningful pipeline progress with several regulatory approvals, encouraging clinical data and strategic investments in promising external innovation," said Robert A. Michael, chairman and chief executive officer, AbbVie. "We’re entering the second half of the year with substantial momentum and are once again raising our full-year outlook."

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Second-Quarter Results

•Worldwide net revenues were $15.423 billion, an increase of 6.6 percent on a reported basis, or 6.5 percent on an operational basis.

•Global net revenues from the immunology portfolio were $7.631 billion, an increase of 9.5 percent on a reported basis, or 9.2 percent on an operational basis.
◦Global Skyrizi net revenues were $4.423 billion, an increase of 62.2 percent on a reported basis, or 61.8 percent on an operational basis.
◦Global Rinvoq net revenues were $2.028 billion, an increase of 41.8 percent on a reported basis, or 41.2 percent on an operational basis.
◦Global Humira net revenues were $1.180 billion, a decrease of 58.1 percent on a reported basis, or 58.2 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $2.683 billion, an increase of 24.2 percent on a reported basis, or 24.0 percent on an operational basis.
◦Global Vraylar net revenues were $900 million, an increase of 16.3 percent.
◦Global Botox Therapeutic net revenues were $928 million, an increase of 14.1 percent on a reported basis, or 14.2 percent on an operational basis.
◦Global Ubrelvy net revenues were $338 million, an increase of 47.1 percent on a reported basis, or 47.2 percent on an operational basis.
◦Global Qulipta net revenues were $267 million, an increase of 77.5 percent on a reported basis, or 76.9 percent on an operational basis.

•Global net revenues from the oncology portfolio were $1.676 billion, an increase of 2.6 percent on a reported basis, or 2.4 percent on an operational basis.
◦Global Imbruvica net revenues were $754 million, a decrease of 9.5 percent.
◦Global Venclexta net revenues were $691 million, an increase of 8.5 percent on a reported basis, or 8.3 percent on an operational basis.
◦Global Elahere net revenues were $159 million, an increase of 24.2 percent on a reported basis, or 23.7 percent on an operational basis.

•Global net revenues from the aesthetics portfolio were $1.279 billion, a decrease of 8.1 percent on a reported basis, or 8.0 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $692 million, a decrease of 5.0 percent on a reported basis, or 4.9 percent on an operational basis.
◦Global Juvederm net revenues were $260 million, a decrease of 24.0 percent.

•On a GAAP basis, gross margin in the second quarter was 71.8 percent. The adjusted gross margin was 84.4 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 21.1 percent of net revenues. The adjusted SG&A expense was 21.0 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 13.8 percent of net revenues. The adjusted R&D expense was 13.7 percent of net revenues.

•Acquired IPR&D and milestones expense was 5.3 percent of net revenues.

•On a GAAP basis, operating margin in the second quarter was 31.7 percent. The adjusted operating margin was 44.3 percent.

•Net interest expense was $678 million.

•On a GAAP basis, the tax rate in the quarter was 39.4 percent. The adjusted tax rate was 16.2 percent.

•Diluted EPS in the second quarter was $0.52 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.97. These results include an unfavorable impact of $0.42 per share related to acquired IPR&D and milestones expense.

Recent Events

•AbbVie announced the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor approved for the treatment of adults with giant cell arteritis (GCA). The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial, which met the primary endpoint of sustained remission and key secondary endpoints. This marks the ninth approved indication for Rinvoq in the U.S., across rheumatology, gastroenterology and dermatology.

•AbbVie announced positive topline results from the first of two pivotal studies in the Phase 3 UP-AA clinical program evaluating the safety and efficacy of Rinvoq in adult and adolescent patients with severe alopecia areata (AA). In the study, Rinvoq achieved the primary endpoint, demonstrating that 44.6% and 54.3% of patients with severe AA treated with Rinvoq 15mg and 30mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤20. Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤10) and complete scalp hair coverage (SALT=0) at Week 24, were also met. Rinvoq’s safety profile in AA was generally consistent with that in approved indications, and no new safety signals were identified in this study.

•AbbVie and Capstan Therapeutics, a clinical-stage biotechnology company dedicated to advancing in vivo engineering of cells through RNA delivery using targeted lipid nanoparticles (tLNPs), announced a definitive agreement under which AbbVie will acquire Capstan. The transaction includes CPTX2309, a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy candidate, currently in Phase 1 development for the treatment of B cell-mediated autoimmune diseases. Additionally, AbbVie will acquire Capstan’s proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo.

•AbbVie announced new data from its Phase 3 TEMPLE head-to-head study evaluating the tolerability, safety and efficacy of Qulipta (atogepant) compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month. In the study, Qulipta met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority versus topiramate, demonstrating clinical efficacy. Full results from the TEMPLE study will be presented at an upcoming medical meeting.

•AbbVie announced that Emrelis (telisotuzumab vedotin-tllv) was granted accelerated approval by the FDA for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received a prior systemic therapy. Emrelis is the first treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression, a population that often faces poor prognosis and has limited treatment options.

•AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta (venetoclax) and acalabrutinib combination therapy for the treatment of chronic lymphocytic leukemia (CLL). This combination therapy has potential to be the first all oral, fixed-duration regimen for previously untreated patients with CLL. The submission is supported by data from the Phase 3 AMPLIFY trial which demonstrated that the combination regimen of Venclexta and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL.

•At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, AbbVie presented key data that showcased significant progress across AbbVie’s robust oncology pipeline, in a range of difficult-to-treat solid tumors and blood cancers. Highlights included new data from AbbVie’s novel investigational antibody-drug conjugates (ADCs) telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced NSCLC, ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN).

•AbbVie announced the global Phase 3 VERONA trial evaluating Venclexta (venetoclax) in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (MDS) did not meet the primary endpoint of overall survival. No new safety signals were observed and results from the trial will be available in a future medical congress and/or publication.

•AbbVie and Ichnos Glenmark Innovation (IGI) announced an exclusive licensing agreement for IGI’s lead investigational asset, ISB 2001, which is being investigated for the treatment of oncology and autoimmune diseases. ISB 2001 is a first-in-class trispecific T-cell engager currently in Phase 1 development for relapsed/refractory (r/r) multiple myeloma (MM).

•AbbVie announced the FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. Mavyret is the first oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV). With this approval, providers can now treat HCV patients immediately at the time of diagnosis.

•AbbVie and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas. The collaboration will leverage AbbVie’s expertise in biotherapeutic drug development and commercialization with ADARx’s proprietary RNA technology to advance next-generation siRNA therapies across neuroscience, immunology and oncology.

Full-Year 2025 Outlook

AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.67 – $11.87 to $11.88 – $12.08, which includes an unfavorable impact of $0.55 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2025. The company’s 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2025, as both cannot be reliably forecasted.

On July 31, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported further progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its Appendix 4C Cash Flow Report (attached) for the quarter ending 30 June 2025 (Press release, Amplia Therapeutics, JUL 31, 2025, View Source [SID1234654649]).

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Key Highlights

• The ACCENT trial achieved a key activity threshold with 17 confirmed partial responses (PRs), showing a 31% response rate for narmafotinib combined with chemotherapy, which is superior to chemotherapy alone (23%).
• Two patients achieved complete responses, including one patient with undetectable cancer lesions for over two months and another with a rare pathological complete response in metastatic pancreatic cancer, garnering significant media attention.
• Progress has been made in initiating a second trial of narmafotinib, combining it with FOLFIRINOX chemotherapy in the USA and Australia, with ethics approvals now secured for both regions.
• Dr Jason Lickliter was appointed Chief Medical Officer in May, bringing extensive experience as a medical oncologist and clinical triallist, having advised Amplia since 2021.
• ACCENT trial data was presented for the initial 26-patient cohort at the prestigious American Association of Cancer Research annual meeting in April. • $27.5m capital raise announced in July 2025, funding the company into 2027

Operations Update

Significant developments in the ACCENT trial were achieved over this quarter. In May we reported that we had achieved the key activity threshold of 15 confirmed partial responses (PRs), demonstrating that the combination of our best-in-class FAK inhibitor narmafotinib with chemotherapy was superior to chemotherapy alone. At the time of writing we now have reported 17 confirmed PR’s, which equates to a response rate of 31%, superior to the 23% response rate observed for chemotherapy alone.

In June we announced that two (2) patients from the trial had achieved complete responses. In one patient, the cancer lesions had decreased in size over the course of treatment to become no longer detectable for over a 2-month period. In the second patient, surgical removal of tissue that appeared to be residual tumour was shown by pathology to be non-malignant tissue, meaning that the patient had achieved a pathological complete response. This latter finding is extremely rare in metastatic pancreatic cancer and resulted in significant media attention for the patient and the hospital where the treatment was delivered.

Further progress has been made towards initiation of the second trial of narmafotinib in pancreatic cancer, this time combining the drug with a different chemotherapy called FOLFIRINOX. This trial, to will be conducted in the USA and Australia, is designed to demonstrate that narmafotinib can also improve the response to FOLFIRINOX. In June we announced that ethics approval had been received from the central US Institutional Review Board (IRB), a critical approval required before sites can initiate patient recruitment. We have now also received similar ethics approval for the Australian sites. The first stage of the trial, where different doses of narmafotinib will be trialled in combination with FOLFIRINOX, is due to start imminently.

In May, the Company announced the appointment of Dr Jason Lickliter as Chief Medical Officer. Dr Lickliter is a highly experienced medical oncologist and clinical triallist and joins the Company in a part- time capacity, whilst retaining a CMO role at clinical trials organisation Nucleus Network. Dr Lickliter has been acting in the role of clinical adviser to Amplia since 2021 and has a deep knowledge of our clinical program and data.

In April, the Company presented ACCENT trial data for the initial cohort of 26 patients at the American Association of Cancer Research annual meeting, a highly prestigious cancer meeting that attracts scientists, clinicians and representatives from pharma and biotech from across the globe.

Outlook and future activities

The Company will continue to collect, analyse and report data from the ongoing ACCENT trial over the coming months. Initiation and progression of the FOLFIRINOX and narmafotinib combination trial, being conducted in the USA and Australia, will also be a major focus of the Amplia team. Interactions with regulatory agencies, in particular the US FDA, is also planned in the coming months.

Capital Raise

On 23 July the Company announced a capital raise of $27.5 million (before costs) to support the ongoing clinical activities and additional planned activities, funding the Company into 2027. The capital raise comprises a successful institutional placement raising $25.0 million (before costs) and a Share Purchase Plan seeking to raise an additional $2.5 million. The Placement was strongly supported by existing and new institutional and sophisticated investors in Australia and offshore.

Financial update

Amplia finished the June 2025 quarter with a cash position of $7.0 million (March 2025: $10.9 million).

During the quarter, the Company had net operating cash outflows of $3.8 million in relation to operating activities (March 2025: $2.7 million). Operating cashflows included:

• Outflows of $0.9 million for staff and administration/corporate costs; and • Outflows of $3.0 million for research and development costs, which primarily related to trial costs, Contract Research Organisation (CRO), manufacturing and other CMC related costs incurred in relation to the ACCENT Phase 2 clinical trial for narmafotinib (AMP945) with gemcitabine and Abraxane and initiation costs with its AMPLICITY Phase 2 study clinical trial for narmafotinib (AMP945) with FOLFIRINOX.

The Company is also expecting to receive its Research and Development Tax Incentive refund for the year ended 31 March 2025 of $3.8m in the September 2025 quarter.

On July 31, 2025 Starpharma (ASX: SPL, US OTC: SPHRY), an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, reported its Quarterly Activities Report and Appendix 4C for the quarter ended 30 June 2025 (Q4 FY25) (Press release, Starpharma, JUL 31, 2025, View Source;mc_eid=bf52dd3418 [SID1234654648]).

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Starpharma’s Chief Executive Officer, Cheryl Maley, commented:

"Over the past year, we have made meaningful progress across our strategic initiatives, aimed at maximising DEP asset value, accelerating early asset development, and building long-term sustainability. Our primary focus has been on out-licensing Starpharma’s clinical-stage DEP assets, establishing new research partnerships to leverage Starpharma’s dendrimer platform technology, increasing revenue from our marketed products, and enhancing the depth our intellectual property portfolio.

"We are pleased to report a $3.1 million increase in underlying customer receipts this financial year, driven by sales of the Viraleze and VivaGel BV products and Petalion research revenue. We have made notable strides with our research partners and expanded our collaborative model through the strategic Star Navigator program. Our radiotheranostics program is also advancing, and we are diligently making important decisions to shape the future of this program effectively.

"This year has not been without its challenges, particularly given the complex geopolitical environment we are navigating. We have actively sought feedback and technical expertise from global conferences, FDA engagement, key opinion leaders, and extensive interactions with investors and international companies. These efforts and learnings are continuously being integrated with our core strategy.

"Looking ahead to FY26, our approach is rigorous and focused on strategic execution, aiming to develop assets with unparalleled commercial potential. We are dedicated to achieving tangible outcomes and delivering value for our shareholders by realising the full potential of Starpharma’s dendrimer platform in collaboration with partners, and through our internal drug discovery and development efforts. Restoring value for our investors remains a top priority. Starpharma’s platform technology presents multiple opportunities for value creation, and we are confident that the progress made in FY25 has laid the groundwork for a successful year ahead."

Maximising DEP Asset Value

In FY25, our top priority was the out-licensing of Starpharma’s clinical-stage assets, DEP SN38 and DEP cabazitaxel, and throughout the year we have committed extensive internal and external resources to achieving this. We have engaged considerably with small to large-size companies, which have shown interest in the DEP assets. The licensing process has taken longer than anticipated, which we attribute to a range of factors including the evolving oncology landscape shifting towards targeted treatment options and the current geo-political environment, which has impacted the biotechnology industry at large. We remain confident in the potential of these assets and the benefits of the DEP technology highlighted by the available clinical data, and are committed to securing partnerships, employing both internal and external resources.

Starpharma engaged with global biotechnology and pharmaceutical stakeholders at the 2025 BIO International Convention in Boston in June. Starpharma’s business development team actively promoted the company’s innovative DEP platform, highlighting the technology’s potential to provide therapeutic and commercial value in oncology and next-generation therapeutics. During the conference, Starpharma initiated and advanced discussions for potential collaborations and licensing opportunities for Starpharma’s clinical-stage assets, as well as for its commercial products VivaGel BV and Viraleze. With over 20,000 attendees focused on business development and strategic alliances, Starpharma’s presence at this high-profile event provided a valuable platform to showcase its leadership and technical capabilities in dendrimer-based drug delivery and platform innovation. The company also gained important insights into evolving industry needs and emerging healthcare opportunities, all of which help shape Starpharma’s business development strategy and R&D priorities.

Accelerating Early Asset Development

Starpharma is strategically intensifying its focus on enhancing its internal pipeline with novel assets that offer innovation, high commercial potential and a strong competitive advantage. Advancing our radiotheranostics program towards the clinic and exploring other emerging therapeutic areas with potential for significant commercial opportunity are integral to our plans for FY26. By doing so, we aim to better position ourselves for successful partnerships, delivering significant value to our shareholders and advancing our mission to improve patient outcomes through our platform dendrimer technology.

DEP radiotheranostics program

Starpharma is continuing to develop and optimise its DEP radiotheranostics assets through preclinical studies to guide important decisions that will shape the clinical program, which is planned for 2026. Alongside the preclinical program, Starpharma is continuing to identify and engage with potential clinical trial sites, and key opinion leaders in the radiopharmaceuticals field, while connecting with and gathering input and insights into radiotheranostic delivery challenges and needs from potential partners.

During the quarter, Starpharma’s business development team participated in the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in the US. SNMMI is one of the industry’s most influential conferences related to radiopharmaceuticals. Participation in this event enabled Starpharma to connect with global stakeholders and gather valuable insights in the rapidly evolving field of radiopharmaceuticals. These interactions help inform and shape our DEP radiopharmaceuticals program, ensuring that our development pathway aligns with clinical needs and commercial opportunities.

Research collaborations

Alongside advancing existing partnerships this quarter, Starpharma established preliminary research programs with two new potential collaborators through its Star Navigator program. These strategic initiatives aim to explore the potential applications of Starpharma’s proprietary dendrimer technology in emerging therapeutic areas. Should these collaborations prove successful, they may evolve into formal research partnerships, potentially adding significant value to the company’s portfolio.

By providing streamlined and efficient pathways for collaboration, Star Navigator enables a broader spectrum of partners, ranging from early-stage researchers to global pharmaceutical companies, to leverage the unique capabilities of Starpharma’s dendrimer technology. This program provides access to the DEP platform, as well as Starpharma’s technical expertise and collaborative frameworks, designed to accelerate and de-risk the process from discovery to development. Expanding Starpharma’s partnership models with the Star Navigator program is a strategic move to unlock new collaboration opportunities and co-develop novel assets, positioning Starpharma for future platform licensing.

Building Long-Term Sustainability

For FY25, underlying customer receipts grew to $4.9 million, a 165% increase on the prior year, excluding the one-time FY24 receipt related to the VivaGel BV exit from Mundipharma. This result highlights our strategic focus on building sustainable revenue growth.

This quarter, Starpharma received payment for the first delivery of Viraleze to Etqan & Nazahah LLC (E&N), kickstarting the product’s expansion into the Saudi Arabian market. E&N’s phased distribution plan, already in motion, will target a wide array of channels, including chain and hospital pharmacies, e-pharmacies, and major retailers.

During the quarter, Starpharma signed a distribution agreement with Synmosa, a Taiwan-based pharmaceutical company, for VivaGel BV distribution in the Philippines, Malaysia, and Singapore. Synmosa’s established presence in women’s health will position VivaGel BV well in these markets. Starpharma is now working with Synmosa to transfer the product registrations for these territories to Synmosa.

Q4 FY25 Financial Summary

Starpharma’s cash balance at 30 June 2025 was $15.4 million. Customer receipts reached $2.0 million this quarter, a 51% increase from the prior quarter (Q3 FY25), driven by sales of the Viraleze and VivaGel BV products.

Net operating cash outflows for the quarter were $2.0 million, including research and development (R&D) costs of $1.8 million and staffing costs of $2.0 million. The company is anticipating an inflow of ~$3.5 million under the Australian Government’s R&D Tax Incentive scheme in H1FY26.

For the full FY25, customer receipts were $4.9 million, up 165% on an underlying basis compared to FY24. Cash operating payments for FY25 of $18.2 million were lower than FY24 payments of $24.2 million due to the completion of the DEP clinical programs and cost reduction initiatives for administration and corporate costs. These financial results reflect Starpharma’s focus on resource management and its ongoing commitment to sustainable business operations.

Staffing costs for the quarter included payments to non-executive and executive directors of $269,000. Other related party payments included service fees of $1,000 to CBE Pure Solutions Pty Ltd, where Starpharma non-executive director Dr Jeff Davies is also a director and shareholder.

Based on Starpharma’s 4C, which is appended, the company’s cash balance of $15.4 million at 30 June 2025 represents 7.7 quarters of funding. Starpharma remains sharply focused on increasing revenue through product sales and licencing agreements, and optimising resource management to improve shareholder value and deliver on our long-term sustainability goals. Through disciplined cost management and a clear strategy to monetise Starpharma’s portfolio and dendrimer platform technology, the company is well-positioned to deliver on its strategy in the year ahead.