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RapportHamlet BioPharma

Hamlet BioPharma AB: Year-end Report (Q4) July 2025 – June 2026

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Hamlet BioPharma redovisar sitt kvartals- och helårsbokslut för perioden 1 april 2026–30 juni 2026 samt 1 juli 2025–30 juni 2026. Bolaget lyfter fram framsteg inom både cancerbehandling och nya behandlingar för bakteriella infektioner, samt att det siktar på kommersiella samarbeten för att ta terapierna vidare. Under kvartalet meddelas bland annat europeiskt regulatoriskt godkännande för en fas III-studie av Alpha1H i blås­cancer och att läkemedelstillverkning för fas III-kvalitet säkrats för distribution till kliniska prövningsställen. Bolaget rapporterar samtidigt fortsatt negativa resultatmått, bland annat EBITDA och EBIT, samt en minskning av kassan under helåret.

  • 10 juni 2026: The Journal of Infectious Diseases publicerade artikeln “Targeting the disease response with NlpD and LytM for effective non-antibiotic treatment of urinary tract infections”.
  • 29 juni 2026: Bolaget mottog europeiskt regulatoriskt godkännande för fas III-studien av Alpha1H i blås­cancer.
  • 5 augusti 2026: Bolaget avyttrade cirka 25,7 miljoner SEK genom utnyttjande av teckningsoptioner av serie TO5B.
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2026-09-18

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Reports Publicerat: 2026-08-28 09:00:00 Hamlet BioPharma AB: Year-end Report (Q4) July 2025 – June 2026 Strong progress in Cancer Therapy and Novel treatments of bacterial infections “We have reached major goals in the fields of Cancer Therapy and Novel Anti-infectives, two of the major causes of disease. Our goal is to make the new therapies available to patients through suitable commercial partnerships. Reaching Phase III studies has been a long-term goal and we have a strong pipeline of drug candidates in our portfolio to continue the translation of innovation into the clinic”, comments Catharina Svanborg, Chairman. “We have maintained strong momentum across both therapeutic areas, with important advances. These achievements reflect the dedication of our teams and provide a solid foundation for continued progress in the coming period”, comments Jakob Testad, CEO. The period in summary FOURTH QUARTER, APR 1, 2026-JUN 30, 2026 (THE GROUP) – Net sales totaled KSEK 0 (0) – Other operating income totaled KSEK 2 (0) – EBITDA amounted to KSEK -13,384 (-15,159) – EBIT amounted to KSEK -15,937 (-17,718) – Earnings per share* was SEK -0.0852 (-0.0985) and -0.0838 after dilution FULL YEAR, JUL 1, 2025-JUN 30, 2026 (THE GROUP) – Net sales totaled KSEK 0 (0) – Other operating income totaled KSEK 55 (208) – EBITDA amounted to KSEK -45,596 (-44,663) – EBIT amounted to KSEK -55,790 (-55,126) – Earnings per share* was SEK -0.2984 (-0.3076) and -0.2936 after dilution – On June 30, 2026, the equity/assets ratio** was 70.1 (83.3) % – Cash amounted to KSEK 5,091 (10,761)

Profit/loss after tax for the period divided by 186,180,709 (177,685,127), respectively 189,245,925, where 186,180,709 is the number of shares outstanding on June 30, 2026, and 189,245,925 shares constitute the number of shares that the Company will have if all subscribed units in the rights issue are paid and exercised. The comparative figure in parentheses was the number of shares on June 30, 2025 ** Equity divided by total capital. Significant Events Apr-Jun 2026 10 June, 2026 – The Journal of Infectious Diseases published the paper “Targeting the disease response with NlpD and LytM for effective non-antibiotic treatment of urinary tract infections”. 22 June, 2026 – Clinical trial expansion in the US, in collaboration with the University of Iowa, to treat high-risk, resistant, non-muscle-invasive bladder cancer (NMIBC). 25 June, 2026 – Hamlet BioPharma secures drug manufacturing at Phase III quality and release of Alpha1H for distribution to clinical trial sites. 29 June, 2026 – Hamlet BioPharma Receives European Regulatory Approval for Phase III Study of Alpha1H in Bladder Cancer. 29 June, 2026 – Hamlet BioPharma announced that the digital analytics platform Briefglance has highlighted Hamlet BioPharma’s collaboration with the University of Iowa. 18 May, 2026 – Hamlet Biopharma announced the successful granting of new patents in Japan and India and a further patent allowance in Japan. Significant Events Jun 2025-Mar 2026 11 August, 2025 – Hamlet BioPharma, announced that the Extraordinary General Meeting resolved to approve the Board of Directors’ proposal for a directed issue of shares and warrants (units). The issue will initially provide the Company with SEK 30 million and, if the warrants are fully exercised, may provide an additional capital contribution of approximately SEK 110 million. In total, this means that the Company may raise up to SEK 140 million in new capital. 21 August, 2025 – Hamlet BioPharma Announces the Completion of the Alpha1H Phase II Study in Non-Muscle Invasive Bladder Cancer. 10 November, 2025 – Hamlet BioPharma Receives FDA Pivotal-Study Feedback for Novel Neoadjuvant Therapy in Non–Muscle Invasive Bladder Cancer March 8, 2026 – Hamlet BioPharma signed a Letter of Intent to outline terms of a potential collaboration and a commercial agreement concerning Alpha 1H March 24, 2026 – Hamlet BioPharma raises approximately SEK 8.5 million through the exercise of warrants of series TO5B, the so-called short-term warrants. Significant Events after the Period 5 August, 2026 – Hamlet BioPharma raised approximately SEK 25.7 million through the exercise of warrants of series TO5B. July 16, 2026 – Discussions with a leading German pharmaceutical company regarding a partnership for bladder cancer treatment are progressing in a very positive manner. OPENING REMARKS This year, Hamlet BioPharma and its close partner Linnane Pharma, have completed a complex and demanding phase of drug development, with great success. Major goals, barely visible on the horizon when the company was listed on Spotlight market, have now been reached and the novel treatments developed by us have become a reality. Three controlled Phase II trials in patients with cancer or infections have been completed, showing successful treatment effects and suggesting a great commercial potential. Cancer therapy: The investigative new drug Alpha1H kills cancer cells by inducing apoptosis and has shown therapeutic efficacy without significant side effects. Alpha1H is Hamlet BioPharma’s Phase III-ready oncology asset for a first in class neoadjuvant therapy for patients with low risk non–muscle invasive bladder cancer (NMIBC). Hamlet BioPharma has received positive feedback from the US Food and Drug Administration (FDA) and the European Medicinal Authority (EMA) to conduct studies in Europe and the US, the clinical Phase III trial infrastructure is established and drug production at Phase III quality completed. In addition, new studies advance the clinical development of Alpha1H. Hamlet BioPharma has recently signed a clinical trial agreement with the University of Iowa, one of the leading U.S. centers for bladder cancer research and therapy. The new study of Alpha1H addresses Carcinoma In Situ (CIS); a severe surface-spreading and therapy-resistant form of bladder cancer where patients may need to remove their bladders to avoid systemic disease. The company’s immediate goal in the cancer area is to conduct the Phase III studies, obtain market approval for Alpha1H as a treatment for bladder cancer and reach the market. We are also extending the clinical studies to include patients with more severe bladder cancer, in collaboration with leading investigators in the US. Ongoing, positive partnering discussions with a major pharmaceutical company in the bladder cancer field, under a letter of intent, are addressing the commercialization of the bladder cancer asset Alpha1H. The dialogue with our potential partner has been very constructive and forward-looking. Infectious disease therapy: The positive results of the clinical studies are further driving a shift in infectious disease management. The four assets targeting the disease in the infected patient are effective against both antibiotic-sensitive and resistant pathogens. A successful Phase II clinical study showed a reduction in symp-toms and recurrences and increase in quality of life and the results were published in a leading international journal. Additionally, immunotherapy has shown positive effects on chronic pain, in patients with bladder pain syndrome. Clinical data from the Phase II study show a reduction in pain scores and an improved quality of life in patients treated with an IL-1 receptor antagonist, affecting nerve cell activation and pain. Molecular advances also make it possible to understand the cause of disease and define patient groups suitable for therapy. Commercial development: The focus of the bladder cancer project is on completing the clinical development and establishing the right commercial framework for market access. Partnering with an established marketing organization would position us to deliver long-term value to patients, healthcare systems and shareholders, subject to successful study outcomes and market approval. The company’s immediate goal is also to extend the clinical studies to include more severe bacterial infections and to take the new anti-infective drug candidates to the clinic. Partnering discussions are ongoing also for these projects. Hamlet BioPharma recently signed a partnering agreement with the South Korean company ImmunoForge to access drug release technology. The company recently raised additional Funds through warranties. We are grateful for the strong investor support and will continue to use our capital effectively for optimal development and commercialization of our drugs. To date, the company has delivered three successful Phase II studies on a budget of about SEK 300 million, including the cancer project in Phase III and the successful development of alternatives to antibiotics. This track record should convince investors of the company’s ability to deliver on strategic goals at low cost and high quality. We would like to thank our multi-national team, as well as our external partners and collaborators, who are behind the successes and remain a resource for the future. Jakob Testad Catharina Svanborg CEO Chairman of the Board EVENTS NOVEL TREATMENTS OF BACTERIAL INFECTIONS On September 4, 2025 – Hamlet BioPharma, announced the PhD thesis defense by Samudra Sabari, M. Sc. Title ‘’Tumor response mechanisms and treatment effects of alpha1-oleate’’ On October 24, 2025 – Hamlet BioPharma announced detailed information from the large-scale international study in infants with severe kidney infections. The large, international study, conducted by scientists and clinicians in Sweden and Singapore involved over 160 infants with their first febrile urinary tract infection and provides one of the most comprehensive molecular data sets ever generated for acute pyelonephritis. The advanced methodology and the way the clinical study was performed reshape the understanding of severe urinary tract infections (UTIs) and open new paths for treatment beyond antibiotics. On October 24, 2025 – Hamlet BioPharma announced that the new molecular concepts for the treatment of bacterial infections were presented at the National Infection Biology meeting, held on October 20-21. Scientists collaborating with Hamlet BioPharma AB, have developed several drug candidates and demon-strated their potent treatment effects in models of severe infections. On November 5, 2025 – Hamlet BioPharma published a newsletter clarifying how a clinical study in infants with febrile kidney infection supports Hamlet BioPharma’s strategy for non-antibiotic treatment of bacterial infections. An international clinical study in infants experiencing their first febrile urinary tract infection included more than 160 infants in Sweden and Singapore. Genome wide technology and a strict clinical pathway makes this one of the most detailed studies ever performed and demonstrates that severe infection and kidney injury are driven by an excessive immune reaction to infection — not by the bacteria themselves. On January 16, 2026 – Hamlet BioPharma welcomed interested parties to the Symposium “Novel Treatments for Infections and Cancer” that took place on the 21st of January. The invited speakers are leading inter-national scientists from the U.S. with a background in infection biology and scientists from Lund University, sharing cutting-edge research and future perspectives on novel therapies for bacterial infections and cancer. On February 23, 2026 – Nature Microbiology published the paper ‘’Targeted innate immune inhibition therapy compared with antibiotics for recurrent acute cystitis: a randomized, open-label phase 2 trial.’’ the paper was accepted on February 12th. This groundbreaking study introduces a new approach to managing recurrent urinary tract infections. Instead of killing the bacteria, the treatment focuses on targeting and calming the disease response. Clinical efficacy of this approach is demonstrated in this study, showing effects comparable to standard antibiotic therapy. This discovery could also mark a major conceptual breakthrough in the fight against antibiotic resistance and the future treatment of infections. On February 3, 2026 – Hamlet BioPharma signed a collaboration agreement with the Korean biotech company ImmunoForge, to develop novel drug delivery technology for the peptide drug NZX, for use in patents with tuberculosis. ImmunoForge based in Seoul, South Korea, contacted Hamlet BioPharma to initiate this collaboration. The company who are developing novel drug delivery techniques for clinical use, will develop novel adminis-tration technology for the NZX peptide, specifically a slow-release technology that would prolong the effect of each treatment. The future rights to the results of the collaboration will be jointly owned by the two companies, as well as future patent rights. On June 10, 2026 – The Journal of Infectious Diseases published the paper “Targeting the disease response with NlpD and LytM for effective non-antibiotic treatment of urinary tract infections.” This study demonstrates that inhibiting the disease response of the host offers an efficient alternative to antibiotics for the treatment of bacterial infections. By inhibiting the disease response to infection and accelerating bacterial clearance, the drug candidates protect infected tissues from disease, with similar efficacy as antibiotics. https://doi.org/10.1093/infdis/jiag243 CANCER THERAPY On August 21, 2025 – Hamlet BioPharma Announces the Completion of the Alpha 1H Phase II Study in Non-Muscle Invasive Bladder Cancer. The completion of the successful Phase II clinical trial of the company’s drug candidate Alpha1H in patients with cancer in the urinary bladder. The final clinical study report based on extensive analyses of clinical and laboratory data highlights the potent treatment effects. All primary and secondary endpoints of safety and efficacy were reached. On September 9, 2025 – Hamlet BioPharma, announces the successful granting of new patents, strength-ening its intellectual property portfolio, reaffirming its position at the forefront of technological innovation. Five new patents in Australia, China, India, Japan, and the US have been granted since the press release on 7 April 2025, which announced three new patents. On September 22, 2025 – Hamlet BioPharma, announced the successful production of a first batch of Alpha1H, the drug candidate targeting Bladder Cancer, at Phase III quality. The batch is now undergoing final evaluation steps, before release for clinical use. On March 6, 2026 – Hamlet BioPharma signed a Letter of Intent to outline terms of a potential collaboration and a commercial agreement concerning Alpha 1H. Hamlet signed a non-binding Letter of Intent (LoI) with an undisclosed company specializing in uro-oncology based in northern Germany. The purpose is to outline terms and conditions for the completion of development and for global commercialization of Alpha 1H in the field of bladder cancer. On June 17, 2026 – Hamlet BioPharma conducted a pre-initiation visit at the Department of Urology at Charles University, Prague, led by Professor Marek Babjuk, a key international opinion leader in bladder cancer therapy. Prague is an important center for bladder cancer research and trials of novel therapies, and the trial technology and collaboration with Hamlet BioPharma and Lund University is established. Professor Babjuk’s group conducted the recently completed, successful Phase II study of Alpha1H in patients with non-muscle invasive bladder cancer (NMIBC). The Phase III study strengthens the commercial potential of Alpha1H and the future market opportunities for the drug. On June 22, 2026 – Hamlet BioPharma announced the signing of a clinical trial agreement with the University of Iowa, one of the leading U.S. centers for bladder cancer research and therapy. The new study advances the clinical development of Alpha1H, a human breast milk derived treatment for bladder cancer, to include Carcinoma In Situ (CIS); a severe surface-spreading and therapy-resistant form of bladder cancer where patients may need to remove their bladders to avoid systemic disease. On June 25, 2026 – Hamlet BioPharma Announces the successful release of the Phase III quality batch of Alpha1H for use in clinical trials of bladder cancer in Europe and the US. Large-scale manufacturing of Alpha1H has been established since the start of the clinical program, with an increase in volumes and tech-nical adjustments during successive phases of the program. The production at Phase III quality requires an extensive and complex development process, which now has been completed. On June 29, 2026 – Hamlet BioPharma announced that the digital analytics platform Briefglance has high-lighted Hamlet BioPharma’’s collaboration with the University of Iowa regarding the development of Alpha1H treatment for patients with severe bladder cancer. The article outlines the advanced scientific and clinical background, the importance of the collaboration and its significance for Hamlet BioPharma. Among other observations, Briefglance describes Alpha1H as a promising treatment candidate for patients who do not respond to BCG therapy; a patient population for whom treatment options remain limited. On June 29, 2026 – Hamlet BioPharma announced regulatory approval from the European Medicines Agency (EMA) for its Phase III clinical study of Alpha1H in bladder cancer. The approval represents a milestone crucial for the clinical development of Alpha1H and provides a clear regulatory path toward a potential future marketing application in Europe. COMPANY AND FINANCE On July 17, 2025 – Hamlet BioPharma proposes to raise capital through a directed new issue of B shares with associated warrants (so-called units). A unit consists of a B share with a short and a longer warrant. The issue initially adds just over SEK 30 million and, if the warrants are fully exercised, can provide a further capital injection of a total of approximately SEK 110 million, which means that the company can add up to SEK 140 million in new capital in total. The issue is aimed at approximately 20 external investors and the subscription price per unit is SEK 4.30. The subscription price corresponds to the average volume-weighted share price during 30 trading days of SEK 4,30. The subscription price for the short option that runs for 12 months is SEK 6 per share and the subscription price for the long option that runs for 30 months is SEK 10 per share. Dilution after full subscription is calculated at just over 10%. Hamlet BioPharma has received binding subscription commitments from all external investors. On July 24, 2025 – Hamlet BioPharma called for an Extraordinary General Meeting in Hamlet BioPharma AB to be held on August 11th, 2025. On August 11, 2025 – Hamlet BioPharma, announced that the extraordinary general meeting decided to approve the board’s proposal for a directed new issue of shares and warrants (units). The issue initially provides the company with SEK 30 million and, if the warrants are fully exercised, may provide an additional capital injection of approximately SEK 110 million. This means that the company can be provided with a total of up to SEK 140 million in new capital. On August 28, 2025 – Hamlet BioPharma released the year-end report (Q4) On September 12, 2025 – The directed issue was registered with the Swedish Companies Registration Office and the number of series B shares in the company has increased by 6,976,744 and the share capital has increased by SEK 69,767.44 from SEK 1,776,851.27 to SEK 1,846,618.71. The number of shares in the company now amounts to 184,661,871, of which 39,947,938 are series A shares and 144,713,933 are series B shares. On March 15, 2026 – A new supplementary subscription period was announced, from 16-23 of March 2026. The Board of Directors had decided to adjust the terms and conditions for warrants of series TO5B ahead of the next subscription period, which runs from 20 July to 31 July 2026. On March 24, 2026 – Hamlet BioPharma announced that the compa

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