Longeveron Inc. - LGVNR STOCK NEWS

Longeveron presented long-term survival data for Lomecel-B in Hypoplastic Left Heart Syndrome (HLHS) patients at the CHSS Annual Meeting. The ELPIS I follow-on study showed 100% 5-year survival and no heart transplants needed after Glenn surgery, compared to 83% survival and 5.2% transplant rate in the Single Ventricle Reconstruction Trial. ELPIS I met its primary safety endpoint with 100% survival and transplant-free rate one year post-treatment. The ongoing ELPIS II Phase 2b trial is evaluating Lomecel-B as an adjunct therapy for HLHS versus standard care at twelve institutions.

Longeveron Inc. (NASDAQ: LGVN) announced that its submission on Lomecel-B™ has been selected for a late breaking poster presentation at the 17th Clinical Trials on Alzheimer's Disease Conference (CTAD24) in Madrid, Spain. The presentation, titled 'Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer's disease', will be held on October 29-30, 2024.

CEO Wa'el Hashad expressed excitement about presenting important Lomecel-B™ data at this leading Alzheimer's research forum, stating that the findings offer potential mechanistic and clinical insights for developing cellular-based therapy for Alzheimer's disease. The abstract will also be included in the special CTAD edition of the Journal of Prevention of Alzheimer's Disease (JPAD), the official journal of the CTAD conference.

Longeveron Inc. (NASDAQ: LGVN) announced that its submission titled "Long-term Transplant-free Survival Is Improved In Hypoplastic Left Heart Syndrome With Cell-based Therapy" has been selected for oral presentation at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting. The presentation will showcase 5-year long-term survival data from the ELPIS I follow-on study, focusing on the potential of Lomecel-B™ as an adjunct therapy for treating Hypoplastic Left Heart Syndrome (HLHS).

The presentation is scheduled for Sunday, October 27, 2024, during the Scientific Session II. Longeveron's CEO, Wa'el Hashad, expressed excitement about sharing the data at this leading forum for congenital heart disease clinical investigation. The company is currently conducting the ELPIS II Phase 2b clinical trial, which may serve as the foundation for a BLA submission for potential approval of Lomecel-B™ if the results are positive.

Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, announced its participation in the UBS Virtual Organ Restoration and Cell Therapy Day on October 15, 2024. The company's CEO, Wa'el Hashad, will engage in a Fireside Chat with Ash Verma, SMID-cap Biotech & Specialty Pharma Analyst at UBS Equity Research.

The virtual event is scheduled for Tuesday, October 15, 2024, from 3:00 p.m. to 3:45 p.m. ET. Interested parties can register for the event by contacting their UBS representative. Additionally, Longeveron's investor presentation is available in the 'Events & Presentations' section of the company's website.

Longeveron focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, positioning itself at the forefront of regenerative medicine research.

Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its participation in the 3rd Annual ROTH Healthcare Opportunities Conference on October 9, 2024 in New York City. The company, which focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, will be represented by Wa'el Hashad, Chief Executive Officer.

Hashad will be speaking on the panel 'Emerging Frontiers in Neuroscience' and will also be available for investor one-on-one meetings. Longeveron has made its investor presentation for the conference accessible in the 'Events & Presentations' section of the company's website, allowing interested parties to review the materials in advance.

Longeveron Inc. (NASDAQ: LGVN) announced its participation in the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa, taking place October 7-9, 2024 in Phoenix, Arizona. The company aims to explore potential partnerships and strategic opportunities for its cellular therapy program in Alzheimer's disease, which has shown positive results in Phase 1 and Phase 2a clinical trials.

Longeveron will also highlight its contract development and manufacturing business at its 15,000 square feet facility with 8 cGMP cleanroom suites. The company's lead investigational therapeutic candidate, Lomecel-B™, has demonstrated promising results in the CLEAR MIND Phase 2a clinical trial for mild Alzheimer's disease. Lomecel-B™ has received both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation from the FDA for this indication.

Longeveron (NASDAQ: LGVN) announced a positive Type C meeting with the FDA regarding the pathway to BLA for Lomecel-B™ in Hypoplastic Left Heart Syndrome (HLHS). Key points include:

• The ongoing Phase 2b clinical trial (ELPIS II) may be deemed pivotal for BLA submission
• Alignment reached on primary and secondary endpoints for ELPIS II
• Agreement on Chemistry, Manufacturing and Controls (CMC) and Potency Assay plans
• ELPIS II builds on positive results from ELPIS I, which showed 100% transplant-free survival up to five years
• Lomecel-B™ has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations

The company views this as a significant step towards potential approval of Lomecel-B™ as an HLHS adjunct therapy.

Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled to take place from September 9-11, 2024 in New York City.

Longeveron's presentation is set for Tuesday, September 10, 2024, from 5:00 – 5:30 p.m. ET. Investors and interested parties can access the webcast through the "Events and Presentations" section of the company's website. A replay of the presentation will be available for 180 days following the conference.

This conference provides Longeveron with an opportunity to showcase its progress in developing cellular therapies for life-threatening and chronic aging-related conditions to a global investment audience.

Longeveron Inc. (NASDAQ: LGVN) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. Positive data from Phase 2a CLEAR MIND trial for Lomecel-B™ in Alzheimer's disease presented at AAIC.

2. FDA granted RMAT and Fast Track designations for Lomecel-B™ in mild Alzheimer's disease.

3. Phase 2b ELPIS II trial for HLHS achieved 70% enrollment, targeting completion by end of 2024.

4. Total operating expenses reduced by 22% year-over-year in H1 2024.

5. Raised $15.3 million in July, extending cash runway through Q4 2025.

6. Revenues increased 105% to $1.0 million in H1 2024, driven by Bahamas Registry Trial and new contract manufacturing business.