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Longeveron Inc. - LGVNR STOCK NEWS

Welcome to our dedicated page for Longeveron news (Ticker: LGVNR), a resource for investors and traders seeking the latest updates and insights on Longeveron stock.

Longeveron LLC is a leading global regenerative medicine company developing innovative cellular therapeutics for chronic life-threatening diseases. Their lead investigational product candidate, LMSC, is based on a specialized cell known as a mesenchymal stem cell derived from the bone marrow of healthy young adult donors. The company's allogeneic, 'off-the-shelf' product is under investigation for chronic conditions of the elderly and other life-threatening diseases with no approved therapeutics currently available, including aging frailty syndrome, Alzheimer's disease, hypoplastic left heart syndrome, and the metabolic syndrome.

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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.

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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.

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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.

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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.

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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.

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Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced it will report its second quarter 2024 financial results on August 14, 2024, after the U.S. financial markets close. The company will also host a conference call and webcast at 4:30 p.m. ET on the same day to provide a business update. Investors can access the conference call via phone or webcast, with an archived replay available on the company's website afterward. Longeveron focuses on developing cellular therapies for life-threatening and chronic aging-related conditions.

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Longeveron (NASDAQ: LGVN) presented positive Phase 2a clinical trial results for Lomecel-B™ in mild Alzheimer's Disease at the Alzheimer's Association International Conference® (AAIC) 2024. The CLEAR MIND trial, involving 48 patients, demonstrated improved cognitive function, quality of life, and brain volume. Key findings include:

- Established safety profile with no hypersensitivity or infusion-related reactions
- Slowing of disease worsening compared to placebo
- Statistically significant improvements in cognitive assessments and daily living activities
- 49% reduction in brain volume loss
- Potential reduction in neuroinflammation

Lomecel-B™ has received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for mild Alzheimer's Disease treatment.

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Longeveron Inc. (NASDAQ: LGVN) has closed a $9.0 million registered direct offering priced at-the-market under Nasdaq rules. The company issued 2,236,026 shares of Class A common stock (or equivalents) at $4.025 per share. In a concurrent private placement, LGVN issued unregistered warrants to purchase up to 2,236,026 shares at $3.90 per share, exercisable for 24 months. H.C. Wainwright & Co. acted as the exclusive placement agent. Longeveron plans to use the net proceeds for clinical and regulatory development of Lomecel-B™, focusing on HLHS and Alzheimer's disease treatments, regulatory approvals, capital expenditures, and working capital.

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Longeveron Inc. (NASDAQ: LGVN) has announced a $9.0 million registered direct offering priced at-the-market under Nasdaq rules. The company will issue and sell 2,236,026 shares of Class A common stock at $4.025 per share. Additionally, in a concurrent private placement, Longeveron will issue unregistered warrants to purchase up to 2,236,026 shares of Class A common stock at $3.90 per share, exercisable for 24 months.

The offering is expected to close on July 19, 2024. H.C. Wainwright & Co. is acting as the exclusive placement agent. Longeveron plans to use the net proceeds for clinical and regulatory development of Lomecel-B™, obtaining regulatory approvals, capital expenditures, working capital, and other corporate purposes.

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Longeveron (NASDAQ: LGVN) has received Fast Track designation from the FDA for Lomecel-B™, its investigational cellular therapy for mild Alzheimer's Disease. This follows the recent Regenerative Medicine Advanced Therapy (RMAT) designation granted on July 9, 2024. The Fast Track status aims to expedite development and review of Lomecel-B™, recognizing its potential to address unmet medical needs in Alzheimer's treatment.

Lomecel-B™ demonstrated promising results in the CLEAR MIND Phase 2a clinical trial, showing an overall slowing/prevention of disease worsening compared to placebo. Full results from this trial will be presented at the upcoming Alzheimer's Association International Conference® (AAIC) in July 2024, including a Featured Research Session oral presentation and a poster presentation.

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FAQ

What is Longeveron LLC known for?

Longeveron LLC is known for developing innovative cellular therapeutics for chronic life-threatening diseases.

What is LMSC?

LMSC is Longeveron's lead investigational product candidate based on a specialized mesenchymal stem cell derived from healthy young adult donors.

What kind of diseases does Longeveron focus on?

Longeveron focuses on chronic conditions of the elderly and other life-threatening diseases such as aging frailty syndrome, Alzheimer's disease, hypoplastic left heart syndrome, and the metabolic syndrome.

What is the unique selling point of Longeveron's products?

Longeveron's products are allogeneic, 'off-the-shelf' solutions for diseases where no approved therapeutics currently exist.

Who are the investors of Longeveron Inc.?

Investors can contact Derek Cole at Investor Relations Advisory Solutions for more information.

How can one get in touch with Longeveron LLC?

For inquiries, contact Derek Cole at Investor Relations Advisory Solutions.

What are the latest developments at Longeveron Inc.?

Stay updated with the latest news and events related to Longeveron Inc. by contacting Derek Cole at Investor Relations Advisory Solutions.

Where can I find more information about Longeveron Inc.?

For more information, visit Longeveron Inc.'s official website or contact Derek Cole at Investor Relations Advisory Solutions.

What are the current projects of Longeveron LLC?

Longeveron LLC is actively working on developing cellular therapeutics for chronic life-threatening diseases, including aging frailty syndrome, Alzheimer's disease, hypoplastic left heart syndrome, and the metabolic syndrome.

How does Longeveron's approach differ from traditional therapeutics?

Longeveron's approach involves utilizing mesenchymal stem cells from healthy young adult donors as an allogeneic, 'off-the-shelf' solution for chronic conditions with no approved therapeutics.

Longeveron Inc.

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