The digital business magazines Time Business News and USA Wire have reported on Hamlet BioPharma's collaboration with the University of Iowa to develop the Alpha1H treatment for severe bladder cancer. The articles discuss the scientific and clinical background of the project, the importance of the collaboration, and its significance for Hamlet BioPharma. Alpha1H is described as a promising treatment for patients who do not respond to BCG therapy, a group with limited treatment options. The magazines also note the EMA approval of the Phase III study and a recent publication in the Journal of Infectious Diseases about a new drug candidate for bacterial infections. This coverage enhances Hamlet BioPharma's visibility in global markets.

Hamlet BioPharma har gjort betydande framsteg inom flera områden under de senaste månaderna. De fortsätter dialogen med en tysk partner om Alpha1H och har fått godkännande från EMA för en fas III-studie av Alpha1H för icke muskelinvasiv blåscancer. De har även tecknat ett avtal med universitetet i Iowa för att utöka studierna till att omfatta svår blåscancer, vilket har ökat intresset i USA. Hamlet har säkrat tillverkning av Alpha1H med fas III-kvalitet och genomfört förberedelser för kliniska studier. I april 2026 erbjöd Hamlet innehavare av TO5B att lösa in teckningsoptioner till 6 kronor per aktie, vilket resulterade i att cirka 1,5 miljoner optioner löstes in och företaget tillfördes cirka 9 miljoner kronor. Det finns fortfarande cirka 5,4 miljoner optioner kvar, vilket kan ge ytterligare 32 miljoner kronor vid full inlösen.

Hamlet BioPharma har avslutat due diligence-processen med ett läkemedelsbolag i norra Tyskland och förhandlar nu kommersiellt med fokus på de tyska bolagets hemmamarknader i Europa och andra stora marknader. Diskussioner om global kommersialisering av Alpha1H pågår också. Dialogen om partnerskap för blåscancerbehandling med en ledande tysk aktör fortsätter positivt och enligt plan, enligt Catharina Svanborg, styrelseordförande och professor vid Lunds universitet. För mer information kan Catharina Svanborg eller Jakob Testad kontaktas.

Hamlet BioPharma has received regulatory approval in Europe for their Phase III study of Alpha1H, a treatment for non-muscle invasive bladder cancer (NMIBC). This approval follows a successful Phase II study and was achieved through collaboration with various regulatory bodies, including the Czech State Institute for Drug Control and the U.S. FDA. The Phase III study will be conducted with Professor Marek Babjuk's team at Charles University in Prague. The approval allows patients with low- to intermediate-risk NMIBC to access the treatment as part of the clinical study. Hamlet BioPharma expresses satisfaction with the efficient review process and looks forward to beginning patient recruitment.

The digital analytics platform Briefglance has reported on Hamlet BioPharma's partnership with the University of Iowa to develop Alpha1H, a treatment for severe bladder cancer. The article discusses the scientific and clinical background, the importance of the collaboration, and its significance for Hamlet BioPharma. Alpha1H is noted as a promising treatment for patients who do not respond to BCG therapy, a group with limited treatment options. Briefglance is a U.S.-focused platform offering business analysis and market intelligence to investors and decision-makers.

Hamlet BioPharma has successfully completed the production of a first batch of Alpha1H at Phase III quality, making it ready for clinical use. To handle increased demand for Phase III-grade materials, the company has expanded the production of the Alpha1 peptide and partnered with Porton Pharmaceutical Chemicals GMBH to ensure cost-effective and advanced manufacturing. The production technology has been adjusted to meet Phase III trial requirements, and the production site has been thoroughly audited. Hamlet BioPharma continues its collaboration with Rechon Life Science AB, which has successfully produced and packaged Alpha1H for clinical trials. The timing of the manufacturing process aligns well with the start of the trials, and additional batches are being produced in preparation for future demand. According to Catharina Svanborg, Founder and Chairman, and Hans Wännman, CMC specialist, the strategy ensures the drug's availability for clinical use.

Hamlet BioPharma bjuder in till sitt månatliga investerarmöte den 30 juni 2026 klockan 12:00. Deltagande sker via en länk till ett Zoom-möte. För mer information kan Jakob Testad, CFO, och Catharina Svanborg, CEO, kontaktas via telefon eller e-post.

Hamlet BioPharma AB has entered a clinical trial agreement with the University of Iowa to advance the development of Alpha1H, a treatment derived from human breast milk, for bladder cancer, including Carcinoma In Situ (CIS). This collaboration aims to address the unmet medical needs of patients with CIS, a severe and therapy-resistant form of bladder cancer. Professor Michael O'Donnell from the University of Iowa, a leader in bladder cancer research, will work with Hamlet BioPharma and Lund University scientists on this project. The study will be conducted under Hamlet BioPharma's existing IND application with the FDA. CIS patients often face high recurrence rates and may require bladder removal if other treatments fail. The University of Iowa's Bladder Cancer Program is a leading center for research and treatment. The trial is funded partly by Hamlet BioPharma, and results will be published in a peer-reviewed journal.

Vid årsstämman för Hamlet BioPharma AB den 4 december 2025 fattades flera beslut. Resultaträkning och balansräkning fastställdes enligt årsredovisningen, och det beslutades att ingen utdelning skulle ges för räkenskapsåret 2024/2025. Styrelsens ledamöter och verkställande direktörer beviljades ansvarsfrihet. Styrelsen ska bestå av fyra ledamöter utan suppleanter, och ett fast arvode på 75 000 kronor betalas till externa styrelseledamöter, medan ordföranden inte får något arvode. Ett registrerat revisorsbolag ska fungera som revisor, med arvode enligt godkänd räkning. Catharina Svanborg, Bill Hansson, Magnus Nylen och Henrik Sundin valdes till styrelsen, med Catharina Svanborg som ordförande. Revisorsgruppen i Malmö AB omvaldes som revisor. Jakob Testad utsågs till ny verkställande direktör, efterträdande Catharina Svanborg.

"Pivotal status" innebär att FDA anser att resultaten från en specifik studie kan användas som grund för ett framtida marknadsgodkännande. Detta är ovanligt för mindre europeiska företag och indikerar att både data och studieupplägg är av hög kvalitet. Pivotal status kan leda till en snabbare väg till marknaden genom möjligheter som Accelerated Approval eller Breakthrough Therapy Designation, vilket kan minska tiden till lansering. Det ger en tydlig väg till marknaden, minskar osäkerheten och stärker investerarnas och partners förtroende. FDA:s stöd är sällsynt för mindre bolag innan fullständig inlämning av Fas III-protokoll. Nästa steg inkluderar att färdigställa studieprotokollet och aktivera ett första studiecenter under första halvåret 2026. Enligt VD Catharina Svanborg är detta ett betydande erkännande av forskningen och potentialen hos Alpha1H att förändra behandlingen av blåscancer.

Hamlet BioPharma had a productive financial year in 2024-2025, continuing its success into the first quarter of 2025-2026. The company completed Phase II studies for cancer and infection treatments, expanded its patent portfolio, and secured both short-term and long-term financing. A directed share issue was approved, potentially raising up to SEK 140 million in new capital. Clinical studies in immunotherapy showed promising results in treating bacterial infections by targeting the disease response rather than the bacteria. Phase III studies and market approval for cancer projects are underway, with positive feedback from the FDA for a novel therapy in bladder cancer. The company is exploring partnerships for global commercialization, supported by strong investor backing. Significant events include a directed share issue raising SEK 30 million initially, with potential for an additional SEK 110 million. Completion of a successful Phase II trial for the Alpha1H drug candidate in bladder cancer was announced, along with new patents strengthening the company's intellectual property. The company also reported progress in producing Phase III quality batches of Alpha1H and presented its latest developments at investor events. Financially, Hamlet BioPharma remains pre-revenue, with a focus on development milestones and partnerships. The first quarter showed a net loss, but the company maintains a strong equity/assets ratio and increased cash reserves following the rights issue. The company does not capitalize R&D expenses, recognizing them as operating expenses. The share structure includes both A and B shares, with ongoing conversion options for shareholders. Transactions with related parties are conducted on market terms, and no dividend is proposed for the financial year 2024/2025. The company continues to focus on innovative treatments for cancer and infections, aiming to capture significant market shares in these growing sectors.

Hamlet BioPharma kommer att hålla ett digitalt investerarmöte den 14 november kl. 12:00. Deltagare kan ställa frågor till företaget via e-post till fraga@investorstudios.se. Mötet kan ses via en YouTube-länk. För ytterligare information kan Catharina Svanborg, VD, eller Gabriela Godaly, styrelseordförande, kontaktas.