Longeveron Issues Letter to Stockholders

Rhea-AI Summary

Longeveron Inc. provides a business update on their lead investigational product Lomecel-B™ and progress in clinical trials for various indications. Phase 2 ELPIS II trial in HLHS has exceeded enrollment threshold, Phase 2a CLEAR MIND trial in Alzheimer's disease on track to report results in October 2023, and Phase 2 trial for Aging-related Frailty ongoing in Japan. New long-term survival data shows positive outcomes. Company has strengthened its Board and executive leadership team. $30 million Rights Offering initiated to fund clinical development. Positive outlook for Lomecel-B™ and potential long-term shareholder value.

Positive

• Phase 2 trials progressing well with positive enrollment and survival data. Potential for Lomecel-B™ in HLHS, Alzheimer's disease, and Aging-related Frailty. Strengthened leadership team. Rights Offering provides balanced approach for funding.

Negative

• None.

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:

Dear Fellow Stockholders:

When I joined Longeveron as CEO, I was intrigued by the potential of our lead investigational product Lomecel-B™ in multiple disease states with clear unmet medical needs, and by the scientific foundation laid for this asset by our co-founder, Chief Scientific Officer, and Chairman Dr. Joshua Hare. Under Josh’s leadership, a compelling clinical program designed to investigate Lomecel-B™ in Hypoplastic Left Heart Syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty has been established. To execute this program, we have taken steps to strengthen our Board and executive leadership team, and initiated the $30 million Rights Offering we announced on August 14, 2023. I write to you today to highlight the progress we are making and to discuss what these steps mean for our shared future.

Lomecel-B™ – Realizing the Potential of Medicinal Signaling Cells

Lomecel-B™ is a living cell product made from specialized cells isolated from the bone marrow of young healthy adult donors. These specialized cells, known as medicinal signaling cells (MSCs), are essential to our endogenous biological repair mechanism. MSCs have been shown to perform a number of complex functions in the body, including the formation of new tissue. They also have been shown to respond to sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative. We believe that Lomecel-B™ may have multiple potential mechanisms of action that may lead to anti-inflammatory, provascular regenerative responses, and therefore may have broad application for a range of rare and aging related diseases.

Our ongoing trials are all progressing and nearing important clinical milestones. As we announced recently, our Phase 2 ELPIS II trial in HLHS has exceeded its 50% enrollment threshold, and we have added an additional study location to further expedite enrollment, and we anticipate completing enrollment in this trial in 2024. New long-term survival data from our prior ELPIS I trial showed that children treated with Lomecel-B™ had 100% survival up to five years of age compared to approximate 20% mortality rate observed from historical control data. The potential of Lomecel-B™ in this indication was further highlighted in the Key Opinion Leader webinar we hosted in August, a replay of which is available here.

In Alzheimer's disease, our CLEAR MIND Phase 2a trial is on track to report top-line results in October, 2023. In a previously completed Phase 1 study, we reported preliminary safety data of Lomecel-B™ used in patients with mild to moderate Alzheimer’s disease. With the Phase 2a CLEAR MIND trial, we hope to build on those results and further demonstrate the potential of Lomecel-B™ as a potential treatment for Alzheimer’s disease.

In our Aging-related Frailty program, earlier this year we announced the dosing of the first patient in our Phase 2 clinical trial, evaluating Lomecel-B™ in this indication in Japan, a country with one of the oldest populations in the world. Enrollment is continuing, and the trial is expected to enroll 45 patients. The primary endpoint of this Phase 2 trial is to evaluate safety with an overarching goal of providing support for an eventual limited approval under the Japan’s Act on the Safety of Regenerative Medicine, or ASRM, which recognizes the tremendous potential, therapeutic potential of cell therapies.

Organizational Strength

To execute these compelling programs, over the last several weeks we have taken steps to strengthen Longeveron at both the Board and executive leadership level. In June, we announced the election of seasoned biotechnology and corporate management experts Khoso Baluch and Jeffrey Pfeffer to our Board of Directors, and I am pleased to join them on our Board to serve in this capacity. We also announced the appointment of Lisa Locklear as our Chief Financial Officer, and Dr. Nataliya Agafonova as Chief Medical Officer. Both Lisa and Nataliya have had distinguished careers in the bio-pharmaceutical industry, and we look forward to their guidance as we advance clinical development of Lomecel-B™.

Rights Offering – Balanced Approach for Needed Capital

On June 27,2023, we filed a registration statement with the SEC to conduct a tradeable subscription rights offering for up to $30.0 million of shares of Class A common stock to stockholders and holders of warrants to purchase common stock as the record date of August 18, 2023. We believe this Rights Offering provides a balanced approach to raising capital necessary to fund clinical development of Lomecel-B™ while remaining cognizant not to dilute existing shareholders. We believe this is an opportunity to participate for all shareholders, and is an important step in fully realizing the potential of Lomecel-B™ and to generating long-term shareholder value.

To conclude, we believe strongly in the potential of Lomecel-B™ in the therapeutic areas we have under investigation, and in the leadership team we’ve assembled to advance our development programs toward near-term milestones. Together with our fellow stockholders, we are confident we can bring this potentially lifesaving therapy to patients in need.

On behalf of my colleagues and the Longeveron Board of Directors, thank you for your continued support.

Sincerely,

Wa’el Hashad
Chief Executive Officer
Longeveron Inc

About the Longeveron Rights Offering

As a reminder, there is an ongoing, effective rights offering on the registration statement previously filed with the Securities and Exchange Commission to conduct a tradable, subscription rights offering. The Rights Offering is being made through a distribution of five tradable subscription rights (listed on the NASDAQ Capital Market under the ticker symbol LGVNR) to purchase shares of Class A common stock for each share of common stock and warrant to purchase common stock owned on the record date, at a $3.00 subscription price per share.

The calendar for the rights offering is as follows:

Thursday, August 17	LGVNV Rights begin to trade.
Friday, August 18	Ex-Rights Day - LGVN shares trade without the rights attached.
Friday, August 18	Record Date – This is the cutoff date that determines the eligibility of stockholders to receive rights.
Tuesday, August 22	Subscription Period Begins – LGVNR rights are credited to brokerage accounts through DTCC.
Thursday, September 21	Subscription Period Ends – 5:00 PM ET unless extended at the Company’s sole discretion.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™ an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently advancing Lomecel-B™ through clinical trials in three indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. Additional information about the Company is available at www.longeveron.com.

Forward-Looking Statements
Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management's current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements regarding the offer and sale of securities, the terms of the offering, about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; the Company’s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company’s ability to attract and retain such personnel; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company’s financial performance and ability to continue as a going concern, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. Additionally, Longeveron makes no assurance that any public offering of its securities as described herein will occur on the timelines, in the manner or on the terms anticipated due to numerous factors. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 14, 2023 and its Quarterly Report on Form 10-Q for the second quarter of 2023 filed with the SEC on August 11, 2023. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor Contact
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: mmoyer@lifesciadvisors.com