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Longeveron

Longeveron, Inc. is a clinical stage biotechnology company. It engages in the development of cellular therapies for specific aging-related and life-threatening conditions. Its lead product, LOMECEL-B, is a cell-based therapy product, which is derived from culture-expanded medicinal signaling cells that are sourced from bone marrow of young, healthy, adult donors. The company was founded by Joshua M. Hare and Donald M. Soffers on October 9, 2014 and is headquartered in Miami, FL.

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Longeveron reports promising Q1 results, secures funding for growth

Longeveron's Q1 2024 earnings call highlighted positive Phase I results for HLHS and cost management efforts. The company secured funding for further development and welcomed new board members. Challenges include regulatory hurdles and market competition, but opportunities lie in expanding therapeutic applications and revenue growth potential.

Longeveron reports positive Q2 results, eyes contract services expansion

Longeveron's Q2 2024 earnings call highlighted strong performance in trials and financials, with a focus on HLHS program advancement and contract services expansion. The company faces challenges in addressing analyst inquiries and maximizing its contract services business potential, but has opportunities for revenue growth and leveraging positive trial outcomes.

Longeveron reports robust revenue growth and progresses towards FDA approval

Longeveron's Q3 2024 performance reflects strong revenue growth and advancements in regulatory pathways for their product candidate, Lomecel-B, across multiple therapeutic areas.
The company's focus on cellular therapies aligns with a lucrative market potential in the U.S., but funding needs for accelerated activities and competitive challenges pose considerations for future strategies.

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Longeveron, Inc. is a clinical stage biotechnology company, which engages in the development of cellular therapies for specific aging-related and life-threatening conditions. Its lead product, LOMECEL-B, is a cell-based therapy product, which is derived from culture-expanded medicinal signaling cells that are sourced from bone marrow of young, healthy, adult donors. The company was founded by Joshua M. Hare and Donald M. Soffer on October 9, 2014 and is headquartered in Miami, FL.

U.S. patent allowance impacts Aging-related Frailty patients receiving vaccines and builds upon a growing patent estate protecting the use of Lomecel-B™ U.S. patent allowance impacts Aging-related Frailty patients receiving vaccines and builds upon a growing patent estate protecting the use of Lomecel-B™

Longeveron Receives Notice of United States Patent Allowance for the Technology Behind its Lead Investigation Product Lomecel-B™

MIAMI, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, today announced the closing of its previously announced registered direct offering, priced at-the-market under Nasdaq rules, for the purchase and sale of 1,355,301 shares of its Class A common stock (“common stock”) at a purchase price of $1.745 per share and associated warrant. In a concurrent private placement, Longeveron issued unregistered warrants to purchase up to an aggregate of 1,355,301 shares of its common stock. The warrants have an exercise price of $1.62 per share, are exercisable immediately upon issuance and have a term of five and one-half (5.5) years from the date of issuance.

Longeveron Announces Closing of $2.36 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

MIAMI, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 1,355,301 of its shares of common stock at a purchase price of $1.745 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, Longeveron has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 1,355,301 shares of its common stock. The warrants will have an exercise price $1.62 per share, will become exercisable immediately upon issuance and have a term of five and one-half (5.5) years from the date of issuance. The offering is expected to close on or about December 22, 2023, subject to the satisfaction of customary closing conditions.

UPDATE -- Longeveron Announces $2.36 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

MIAMI, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 1,355,301 of its shares of common stock at a purchase price of $1.62 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, Longeveron has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 1,355,301 shares of its common stock. The warrants will have an exercise price $1.62 per share, will become exercisable immediately upon issuance and have a term of five and one-half (5.5) years from the date of issuance. The offering is expected to close on or about December 26, 2023, subject to the satisfaction of customary closing conditions.

Longeveron Announces $2.36 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

MIAMI, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, today announces additional new clinical and biomarker results from its Phase 2a CLEAR MIND trial of its investigational product Lomecel-B™ for the treatment of mild Alzheimer's disease.

Longeveron Announces Additional Positive Clinical Data and Imaging Biomarker Results from the CLEAR MIND Phase 2a Trial of Lomecel-B™ in the Treatment of Mild Alzheimer's Disease

Extended Follow Up Data Show Continued, Transplant Free Survival of All Patients Results Support Continued Investigation of Lomecel-B TM As Adjunct to Stage II Surgery in HLHS - Enrollment ongoing in Phase 2 ELPIS II trial - MIAMI, Nov. 11, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN NASDAQ: LGVNR) (“Longeveron” or “Company”), a clinical-stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, announced today that extended long-term follow-up data from the Company's ELPIS I trial of Lomecel-BTM for patients with hypoplastic left heart syndrome (HLHS) is being presented as a poster at the annual Scientific Sessions of the American Heart Association (AHA), being held in Philadelphia, PA on November 11-13, 2023. The poster, titled Long-term Transplant-free Survival Is Improved in Hypoplastic Left Heart Syndrome with Cell-based Therapy (Sunjay Kaushal, et al), showed that 100% of the 10 patients who participated in the ELPIS I trial survived and remained heart transplant-free for up to 5 years of age after receiving Lomecel-BTM during their Stage II surgery.

Long-term Survival Data from Longeveron's ELPIS 1 Trial Presented at the 2023 Scientific Sessions of the American Heart Association

Longeveron Inc. (NASDAQ:LGVN ) Q3 2023 Earnings Conference Call November 10, 2023 8:30 AM ET Company Participants Mike Moyer - Managing Director, LifeSci Advisors, LLC Wa'el Hashad - CEO Nataliya Agafonova - CMO Lisa Locklear - CFO Joshua M. Hare - Co-Founder, Chief Science Officer and Chairman Conference Call Participants Michael Okunewitch - Maxim Group Operator Greetings, and welcome to the Longeveron's Third Quarter 2023 Earnings call.

Longeveron Inc. (LGVN) Q3 2023 Earnings Call Transcript

Top Line Results from CLEAR MIND Alzheimer's disease Trial Affirm Safety Profile of Lomecel-B™ and Provide Efficacy Signal; Full Study Data Remains on Track to Share in Coming Weeks

Longeveron Reports Third Quarter 2023 Results and Provides Corporate Update

MIAMI, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, announced today that it will report its third quarter 2023 financial results prior to the market open on Friday November 10, 2023. The Company will host a conference call and webcast that day to discuss the results, and provide an update on its clinical programs and corporate activities. A question-and-answer session will follow the prepared remarks.

Longeveron to Report Third Quarter 2023 Results and Provide Corporate Update on November 10, 2023

LOS ANGELES, Oct. 24, 2023 (GLOBE NEWSWIRE) -- via IBN -- Longeveron Inc. (NASDAQ: LGVN), a clinical-stage biotechnology company developing regenerative medicines to address unmet medical needs for specific aging-related and life-threatening conditions, today announces that it has been featured in a broadcast via NetworkNewsAudio (“NNA”), a solution that delivers additional visibility, recognition and brand awareness in the investment community via distribution to thousands of syndication points. The audio news release covers Longeveron's recent announcement of positive top-line results from its Phase 2a trial of its investigational product Lomecel-B™ for the treatment of mild Alzheimer's disease.

Longeveron Inc. Featured in Syndicated Broadcast Highlighting Top-Line Results from CLEAR MIND Phase 2a Clinical Trial of Lomecel-B™ for the Treatment of Mild Alzheimer's

MIAMI, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, today announced the closing of its previously announced registered direct offering, priced at-the-market under Nasdaq rules, for the purchase and sale of 2,424,243 shares of its Class A common stock (“common stock”) or common stock equivalents in lieu thereof, at a purchase price of $1.65 per share, or per common stock equivalent in lieu thereof. In addition, in a concurrent private placement, Longeveron issued unregistered Series A warrants to purchase up to an aggregate of 2,424,243 shares of its common stock and unregistered Series B warrants to purchase up to an aggregate of 2,424,243 shares of its common stock. The warrants have an exercise price of $1.65 per share and are exercisable upon the effective date of stockholder approval of the issuance of the shares underlying the warrants. The Series A Warrants and Series B Warrants have terms of five and one-half years and eighteen months from the date of issuance, respectively.

Longeveron Announces Closing of $4 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

MIAMI, Oct. 12, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 2,424,243 of its shares of Class A common stock (“common stock"), or common stock equivalents in lieu thereof, at a purchase price of $1.65 per share, or per common stock equivalent in lieu thereof, in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, Longeveron has also agreed to issue and sell unregistered Series A warrants to purchase up to an aggregate of 2,424,243 shares of its common stock and unregistered Series B warrants to purchase up to an aggregate of 2,424,243 shares of its common stock. The offering is expected to close on or about October 13, 2023, subject to the satisfaction of customary closing conditions.

Longeveron Announces $4 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Longeveron Inc. shares LGVN, +4.58% jumped 16% premarket on Thursday after the clinical-stage biotech company announced positive results from a trial of its Alzheimer's treatment Lomecel-B.

Longeveron stock jumps on Alzheimer's trial results

Company to Hold Conference Call & Webcast Today, October 5 at 8:00am ET Primary Endpoint of Safety Met Across all Study Groups Statistical Significance Met for Secondary Endpoint Composite Alzheimer's Disease Score (CADS) for Lomecel-B™  Low-Dose and for the Pooled Lomecel-B™  Treatment Group Relative to Placebo Other Doses Demonstrated Numerical Slowing/Prevention of Disease Worsening Relative to Placebo Additional Biomarker Data Expected to be Announced in the Coming Weeks MIAMI, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, today announced positive top-line results from its Phase 2a trial of its investigational product Lomecel-B™ for the treatment of mild Alzheimer's disease. The Company is hosting a conference call and webcast today at 8:00 AM ET to discuss the results.

Longeveron Announces Positive Top-Line Results for Lomecel-B™ in its CLEAR MIND Phase 2a Clinical Trial in the Treatment of Mild Alzheimer's Disease

MIAMI, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN NASDAQ: LGVNR) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, announces that Wa'el Hashad, Chief Executive Officer of Longeveron, has issued a Letter to Stockholders providing a business update. Full text of the letter, which has been posted to the Company's website, is as follows:

Longeveron Issues Letter to Stockholders

MIAMI, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN NASDAQ: LGVNR) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, announced today an abstract highlighting long-term survival data from the Company's ELPIS 1 trial of Lomecel-B™ for patients with hypoplastic left heart syndrome (HLHS) has been accepted for presentation as a poster at the upcoming meeting of the American Heart Association (AHA).

Long-term Survival Data from Longeveron's ELPIS 1 Trial Accepted for Presentation at the 2023 Scientific Sessions of the American Heart Association

MIAMI, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN NASDAQ: LGVNR) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, announced today that the Company's management will be participating in the 25th Annual H.C. Wainwright Global Investment Conference, to be held September 11-13 , 2023 in New York, NY.

Longeveron to Present at the 25th Annual H.C. Wainwright Global Investment Conference

MIAMI, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN NASDAQ: LGVNR) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, announced today that the Company's management will be participating in the 149th Annual Conference of the National Investment Banking Association, to be held in Fort Lauderdale, FL, September 6-7, 2023.

Longeveron to Participate in the 149th Annual National Investment Banking Association Conference

MIAMI, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN NASDAQ: LGVNR) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, announced today that the subscription period for its previously announced rights offering has begun. The subscription price is $3.00 per share. The subscription period for the rights offering ends at 5:00 p.m. Eastern Time on Thursday, September 21, 2023, unless extended at the Company's sole discretion. Longeveron reserves the right to modify, extend, postpone or cancel the rights offering at any time prior to the termination of the subscription period or any extension thereof.

Longeveron Rights Offering Subscription Period Begins

MIAMI, Aug. 16, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, announced today that its registration statement previously filed with the Securities and Exchange Commission to conduct a tradable subscription rights offering has been declared effective, and that it has finalized the rights offering calendar.

Longeveron Rights Offering Declared Effective and Calendar Finalized

MIAMI, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced it will host a virtual KOL Event on August 16, 2023 at 10:00 AM ET. Click here to register and attend.

Longeveron to Host Key Opinion Leader Event on Medicinal Signaling Cells (MSCs) for Hypoplastic Left Heart Syndrome (HLHS) with Lomecel-B™ on August 16, 2023

MIAMI, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, announced today that it has filed an amended registration statement with the Securities and Exchange Commission to conduct a tradable subscription rights offering to holders of its Class A common stock, Class B common stock and warrants to purchase its Class A common stock.

Longeveron Announces Pricing for Rights Offering and Expected Calendar

Longeveron Inc. (NASDAQ:LGVN ) Q2 2023 Earnings Conference Call August 11, 2023 8:00 AM ET Company Participants Mike Moyer - Managing Director, LifeSci Advisors, LLC Wa'el Hashad - Chief Executive Officer Nataliya Agafonova - Chief Medical Officer Lisa Locklear - Chief Financial Officer Joshua Hare - Co-Founder, Chief Science Officer and Chairman Conference Call Participants Michael Okunewitch - Maxim Group Operator Greetings, and welcome to the Longeveron's Second Quarter 2023 Earnings call. At this time, all participants are in a listen-only mode.

Longeveron Inc. (LGVN) Q2 2023 Earnings Call Transcript

ELPIS II Study Exceeds 50% Enrollment Threshold for Phase 2 Trial of Lomecel-B™  in HLHS Top Line Results for CLEAR MIND Alzheimer's disease Phase 2a Trial Anticipated by October 2023 Company Strengthens Leadership Team and Board of Directors with Distinguished New Additions Company to Hold Conference Call and Webcast Today, August 11, 2023 at 8am Eastern Time MIAMI, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, announced today its results for the quarter ended June 30, 2023 and provided a corporate update. “During our second quarter and in recent weeks, we made significant progress advancing our Lomecel-B™ clinical programs, exceeding the 50% enrollment threshold for our ELPIS II trial in hypoplastic left heart syndrome (HLHS) patients and announcing new long-term survival data from our ELPIS I study,” said Wa'el Hashad, Chief Executive Officer of Longeveron.

Longeveron Reports Second Quarter 2023 Results and Provides Corporate Update

Company Activates Additional Study Location to Expedite Enrollment Completion Key Opinion Leader Webinar Highlighting the Potential for Lomecel-B™  in the Treatment of HLHS to be held Wednesday, August 16, 2023 at 10:00 AM ET MIAMI, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, announced today the Phase 2 ELPIS II trial, funded by the National Heart, Lung, and Blood Institute (NHLBI) and using the Company's Lomecel-B™ asset in Hypoplastic Left Heart Syndrome (HLHS), has surpassed the 50% enrollment threshold. Additionally, the trial has activated its eighth clinical site location – one additional site beyond the seven originally planned -- in order to try to expedite the completion of the trial enrollment.

News for Longeveron Stock (LGVN)