Hamlet BioPharma B

Hamlet BioPharma, a pharmaceutical company focused on cancer and infection treatments, announced a successful meeting with the U.S. FDA on June 24, 2025. The meeting outlined a clear path to Phase III trials for their Alpha1H drug, aimed at treating bladder cancer. The FDA responded positively to the data from Hamlet's completed Phase II study and provided feedback on the design of the upcoming Phase III trial for NMIBC patients. Hamlet BioPharma will integrate this feedback into their trial protocol, with plans to start the Phase III trial pending final agreement and regulatory approval. The meeting was a significant step in the regulatory process, aligning Hamlet with the FDA on trial design. CEO Catharina Svanborg expressed gratitude for the FDA's input, highlighting the progress toward offering a new treatment for bladder cancer.

Hamlet BioPharma has announced progress in tuberculosis therapy through a study led by Professor Gabriela Godaly, which has been accepted for publication in Frontiers in Microbiology. The study focuses on the antimicrobial peptide NZ2114, a plectasin variant, as a potential treatment for Mycobacterium tuberculosis. NZ2114 has shown promising results by overcoming the bacterium's complex membrane, demonstrating strong antimycobacterial activity, and working synergistically with first-line TB drugs. It is stable in serum and non-toxic to human cells. Additionally, NZ2114 has shown effectiveness against several Gram-positive bacteria, including MRSA. In a murine TB infection model, NZ2114 achieved an 81% reduction of M. tuberculosis after three doses. These findings suggest that NZ2114 could be a strong candidate for future TB treatment strategies. For more information, contact Gabriela Godaly or Catharina Svanborg at Hamlet BioPharma.

Hamlet BioPharma bjuder in till ett månatligt investerarmöte den 18 juni 2025 klockan 12:00. Deltagare kan ansluta via en angiven Zoom-länk. För mer information kan Catharina Svanborg, VD, och Jakob Testad, CFO, kontaktas via telefon eller e-post.

Hamlet BioPharma is advancing its drug candidate Alpha1H, which has shown promising results in treating bladder cancer, reaching all primary endpoints of safety and efficacy in a Phase I/II trial. The company is preparing for Phase III studies following a successful trial and FDA Fast Track status. Hamlet BioPharma is also exploring immunotherapy with anakinra, which has shown efficacy in treating recurrent acute cystitis and bladder pain syndrome. The company is focused on strategic alliances and commercial collaborations to bring its therapies to market. Financially, Hamlet BioPharma reported no net sales and a loss before tax for both the parent company and the group for the third quarter and the first nine months of the fiscal year. The company has a strong equity/assets ratio and is investing in R&D without capitalizing these expenses. Hamlet BioPharma is traded on the Spotlight Stock Market, with ongoing changes in share classification. The company continues to engage with investors and stakeholders through digital events and meetings.

Hamlet BioPharma kommer att hålla en digital pressträff den 22 maj 2025 kl. 12.00 för att presentera sin kvartalsrapport för det tredje kvartalet 2024/2025. Under pressträffen kommer bolaget att sammanfatta kvartalets resultat och diskutera aktuella frågor med deltagarna. Det finns möjlighet att ställa frågor i kommentarsfältet under sändningen, och frågor kan även skickas i förväg via e-post. För mer information kan Catharina Svanborg, företagets VD, och Gabriela Godaly, styrelseordförande, kontaktas.

Hamlet BioPharma har tillsammans med Lunds universitet gjort viktiga forskningsframsteg med läkemedelskandidaten Alpha1H mot urinblåsecancer. En ny studie visar att Alpha1H påverkar tumörcellernas endoplasmatiska nätverk (ER) genom att omstrukturera det, vilket hjälper till att kapsla in giftiga ämnen i döende cancerceller. Detta minskar toxiciteten och skyddar frisk vävnad. Upptäckten ger stöd för Alpha1H:s effektivitet och säkerhet, vilket kan ge företaget en konkurrensfördel och öka investerares förtroende. Denna forskning kan också bana väg för framtida studier och utökad användning av Alpha1H i andra cancerformer. Blåscancer drabbar över 600 000 personer globalt årligen, och dessa resultat kan leda till bättre behandlingar med färre biverkningar.

Hamlet BioPharma, in collaboration with Lund University, has made a significant scientific discovery regarding their drug candidate Alpha1H for treating bladder cancer. A study published in Life Science Alliance reveals that Alpha1H targets the endoplasmic reticulum (ER) in tumor cells, causing it to restructure and encapsulate toxic components, which helps kill tumor cells while sparing healthy tissue. This discovery, aided by advanced imaging technologies, highlights Alpha1H's potential therapeutic benefits and strategic advantages, such as increased efficacy, market competitiveness, and enhanced credibility with investors. Bladder cancer affects over 600,000 people annually, and this breakthrough may lead to more effective treatments with fewer side effects. For further details, contact Catharina Svanborg or Gabriela Godaly.

Hamlet BioPharma AB har meddelat att deras läkemedelskandidat Alpha1H presenterades vid American Association for Cancer Research (AACR) Annual Meeting 2025 i Chicago, USA. Detta anses som en betydande prestation inom cancerforskning. Alpha1H, som är baserat på en syntetisk peptid, har visat sig effektivt i prekliniska modeller av blåscancer och har uppnått sina primära mål i fas II-studier utan tecken på toxicitet. Läkemedlet har också fått Fast Track Designation från FDA, vilket understryker dess potential inom blåscancerbehandling. Presentationen vid AACR stärker Hamlet BioPharmas position och ökar intresset för deras forskning.

Hamlet BioPharma bjuder in till sitt månatliga investerarmöte den 23 april 2025 kl. 12:00. Deltagare kan ansluta via en Zoom-länk. Företaget har även släppt en ny teaser som sammanfattar deras position, vilken kan ses via en länk. För mer information kan Jakob Testad, CFO, och Catharina Svanborg, CEO, kontaktas via telefon eller e-post.

Hamlet BioPharma, a pharmaceutical company focusing on cancer and infection drugs, has announced scientific advances in identifying patient groups for new bacterial infection therapies. These advances were made in collaboration with Lund University scientists. Two clinical studies on kidney infection responses, published in Life Science Alliance, used genome-wide analysis tools. The studies, conducted in Singapore and Sweden, found that severe kidney infections in infants are caused by excessive immune responses, similar to cytokine storms seen in some COVID-19 cases. The new therapies being developed successfully address these immune responses in animal models and have shown positive results in clinical studies of recurrent acute cystitis. The research highlights the potential for non-antibiotic treatments and helps identify patient susceptibility factors and disease markers for matching patients with appropriate therapies. The studies are supported by a collaborative clinical network and advanced genome-wide analysis technology at Lund University. For more information, contact Catharina Svanborg or Ines Ambite.