Xinnate raises SEK 31 million in oversubscribed share issue
Xinnate today announced successful closure of its share issue, raising 31 million in new capital for the development of TCP-25. The issue was oversubscribed demonstrating strong interest and confidence from both existing and new shareholders.
- We extend our sincere thanks for our investors’ continued support, says CEO Helene Hartman. This marks a significant milestone accelerate the path to partnering, market and hence patients suffering from Epidermolysis Bullosa.
The funding enables us to move forward with our accelerated development strategy, following the transition to a CDMO partner with commercial manufacturing capacity. This includes:
- Advancing the pivotal STEP study for EB patients, backed by positive FDA feedback.
- Securing continued GMP manufacturing of clinical study material, following successful production of a pilot batch.
- Preparing for a potential commercial partnership and future NDA submission.
To accommodate those investors who were not allocated shares in this round, the Board plans to launch a directed issue during the summer.
New Addition to Xinnate’s Board: Dr Per Norlén, MD PhD
We are pleased to welcome Dr Per Norlén to Xinnate’s board of directors.
Dr Norlén brings over 20 years of experience in clinical drug development and leadership roles at AstraZeneca and several private and publicly listed biotechs, including Alligator Bioscience, Targinta, Evaxion Biotech, and WntResearch. He is currently the CEO of Strike Pharma.
His expertise will be invaluable as we advance our work developing innovative therapies for complex skin conditions and wounds.
Xinnate announces successful FDA meeting for TCP-25
Xinnate announces successful FDA meeting for TCP-25
Lund, Sweden – Xinnate AB, a clinical-stage company focused on developing treatments for patients with Epidermolysis Bullosa (EB), today announced that positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), Division of Dermatology and Dentistry, in the Office of Immunology and Inflammation. As a result of the meeting, the upcoming study is now being upgraded to serve as a registrational trial.
“We are grateful that we have FDA’s support for the development program of the drug candidate TCP-25 and the upcoming clinical trial”, says Helene Hartman, CEO of Xinnate. FDA acknowledged the unmet medical need in the EB population and provided valuable input to the study design which would allow the study to be upgraded to serve as the basis of registration upon successful completion.
The clinical trial, which is named the STEP trial, is an international multicenter, randomized, double-blind, placebo controlled study designed to assess the efficacy and safety of TCP-25 in patients with dystrophic and junctional EB. The STEP trial is planned to start during 2025.
TCP-25 is an immunomodulatory peptide being developed by Xinnate for the treatment of the rare, devastating disease EB as well as other conditions involving inflammation and infection in skin and wounds. TCP-25 has demonstrated dual-action capabilities, targeting both inflammation and bacterial infection to promote faster and more effective healing. Earlier this year the US Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for the company’s drug candidate TCP-25 for the treatment of the severe disease Epidermolysis Bullosa (EB).
For more information, please contact:
Helene Hartman, CEO of Xinnate, helene.hartman@xinnate.com, +46725120312
About Xinnate AB
Xinnate is a clinical-stage pharmaceutical company pioneering novel therapies based on a proprietary peptide technology. These therapies aim to address dysfunctional healing by targeting the interplay of microbial presence and inflammatory responses. With an ambitious development program, Xinnate is dedicated to transforming the lives of patients with Epidermolysis Bullosa and other inflammatory skin conditions. A three-part Phase 1 study of the first drug candidate, TPC-25 gel, has been completed including a group of patients with Epidermolysis Bullosa. The clinical phase 2/3 STEP study is planned to start during 2025.
Xinnate is a member for SmiLe Venture Hub at Medicon Village in Lund, Sweden.
www.xinnate.com/
Xinnate tillkännager lyckat FDA-möte för TCP-25
Lund, Sverige – Xinnate AB, ett läkemedelsföretag i klinisk fas som fokuserar på att utveckla behandlingar för patienter med Epidermolysis Bullosa (EB), meddelade idag att de fått positiv återkoppling från sitt Type C-möte med amerikanska läkemedelsmyndigheten FDA (U.S. Food and Drug Administration), Division of Dermatology and Dentistry, inom Office of Immunology and Inflammation. Med anledning av detta uppgraderas nu den kommande kliniska studien för att kunna ligga till grund för en registreringsansökan.
"Vi är tacksamma över att ha FDA:s stöd för vårt utvecklingsprogram för läkemedelskandidaten TCP-25 och den kommande kliniska studien", säger Helene Hartman, VD för Xinnate. FDA bekräftar det stora medicinska behovet hos EB-patienter och gav i mötet värdefull input till studiedesignen, som leder till att studien kan uppgraderas till att utgöra grund för registrering vid ett framgångsrikt genomförande.
Den kliniska prövningen, som kallas STEP-studien, är en internationell, multicenter, randomiserad, dubbelblind och placebokontrollerad studie med syfte att utvärdera effektivitet och säkerhet av TCP-25 hos patienter med dystrofisk och junktional EB. STEP-studien planeras att starta under 2025.
TCP-25 är en immunmodulerande peptid som utvecklas av Xinnate för behandling av den sällsynta och förödande sjukdomen EB, samt andra tillstånd som involverar inflammation och infektion i hud och sår. TCP-25 har visat dubbelverkande egenskaper genom att rikta in sig både på inflammation och bakteriell infektion för att främja snabbare och mer effektiv läkning. Tidigare i år beviljade den amerikanska läkemedelsmyndigheten (FDA) sårläkemedelsstatus (Orphan Drug Designation, ODD) för TCP-25 för behandling av Epidermolysis Bullosa (EB).
För mer information, vänligen kontakta:
Helene Hartman, VD för Xinnate
helene.hartman@xinnate.com
+46 72 512 03 12
Om Xinnate AB
Xinnate är ett läkemedelsutvecklingsbolag i klinisk fas som utvecklar nya behandlingar baserade på en egenutvecklad peptidteknologi. Dessa behandlingar syftar till att förbättra läkningsprocesser genom att påverka samspelet mellan mikrobiell närvaro och inflammatoriska reaktioner. Med ett ambitiöst utvecklingsprogram är Xinnate dedikerat till att förbättra livet för patienter med Epidermolysis Bullosa och andra inflammatoriska hudsjukdomar. En tre-delad fas 1-studie med den första läkemedelskandidaten, TCP-25 gel, är slutförd med goda resultat, inklusive en patientgrupp med målindikationen EB. Den kliniska fas 2/3-studien STEP planeras att starta under 2025.
Xinnate receives Orphan Drug Designation from US FDA for TCP-25
Xinnate receives Orphan Drug Designation from US FDA for TCP-25
Xinnate AB today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the company’s drug candidate TCP-25 for the treatment of the severe disease Epidermolysis Bullosa (EB).
"We are excited about FDA’s decision to grant ODD for TCP-25, recognizing its unique mechanism of action, the robust data generated during preclinical and clinical development and the significant unmet medical needs of patients suffering from EB. This designation underscores the potential of TCP-25 as a transformative treatment option and will facilitate our efforts to bring this therapy to patients who needs it most,” said Helene Hartman, CEO of Xinnate.
TCP-25 is an immunomodulatory peptide being developed by Xinnate for the treatment of the rare, devastating disease EB as well as other conditions involving inflammation and infection in skin and wounds. TCP-25 has demonstrated dual-action capabilities, targeting both inflammation and bacterial infection to promote faster and more effective healing. The FDA grants OODs to support the development of therapies for rare disorders affecting fewer than 200,000 people in the US. The designation qualifies a company for several benefits, including tax credits, exemptions from certain FDA fees for clinical trials, and seven years of market exclusivity following drug approval.
For more information, please contact:
Helene Hartman, CEO of Xinnate, helene.hartman@xinnate.com
About Xinnate AB
Xinnate is a clinical-stage pharmaceutical company pioneering novel therapies based on a proprietary peptide technology. These therapies aim to address dysfunctional healing by targeting the interplay of microbial presence and inflammatory responses. With an ambitious development program, Xinnate is dedicated to transforming the lives of patients with Epidermolysis Bullosa and other inflammatory skin conditions. A three-part Phase 1 study of the first drug candidate, TPC-25 gel, has been completed including a group of patients with Epidermolysis Bullosa. The phase 2 study is planned to start during 2025.
Xinnate AB partners with Destum Partners, Inc. a leading global, advisory firm
Lund, Sweden – Xinnate AB today announced a strategic collaboration with Destum Partners, Inc., a leading global, advisory firm specializing in the life sciences sector. Under the agreement, Destum Partners will act as the exclusive advisor to Xinnate AB for identifying and developing partnership opportunities for TCP-25 gel, the company’s innovative drug candidate for the treatment of Epidermolysis Bullosa (EB). EB is a group of rare, often very severe inflammatory disorders which causes fragile, blistering skin, resulting in recurring and chronic wounds.
“Following our positive Phase 1 data, including patients with Dystrophic EB, we sought the expertise of Destum Partners to support our mission of finding the right partner to advance TCP-25 gel and bring this much-needed treatment to patients,” said Helene Hartman, CEO of Xinnate AB. “With Destum Partners’ guidance, we are now ramping up our partnering activities, including introducing TCP-25 to potential strategic partners at the upcoming JP Morgan Healthcare Conference in January.”
“TCP-25 is an exciting drug candidate that has already attracted significant interest,” added Tom Filipczak, Managing Director and Partner at Destum Partners. “We are thrilled to collaborate with the Xinnate team and contribute to their efforts to unlock the full potential of TCP-25 through strategic partnerships.”
For more information
Helene Hartman, CEO of Xinnate AB
Helene.hartman@xinnate.com
Phone: +46 (0)72-512 03 12
About Destum Partners, Inc.
Destum Partners, Inc. (www.destumpartners.com) is a global, advisory and consultancy firm specializing in the biopharmaceutical and life sciences industries. For more than 18 years, Destum Partners has worked with clients ranging from large, multinational Fortune 500 companies through mid-sized/early-stage companies, globally completing transactions and providing customized market research and valuations. Destum Partners is therapeutically agnostic and has completed over USD $5.15B in deal value.