Preliminary Prospectus

Subject to Completion, Dated April 5,16, 2024

Longeveron Inc.PRELIMINARY PROSPECTUS

Up to 2,461,538

145,020 Shares of Class A common stock
UpCommon Stock

This prospectus relates to 2,461,538 Class A Common Warrantsthe re-sale or other disposition from time to Purchasetime by certain selling stockholders identified herein (each, a “Selling Stockholder” and, together, the “Selling Stockholders”) or their pledgees, assignees, distributees and successors-in-interest, from time to time, of up to 2,461,538 Shares of
Class A common stock
Up to 2,461,538 Pre-Funded Warrants to Purchase up to 2,461,538 Shares of
Class A common stock
Up to 172,308 Placement Agent Warrants to Purchase up to 172,308 Shares of
Class A common stock
Up to 5,095,384 Shares of Class A common stock Underlying the Class A Common Warrants, Pre-Funded Warrantsand Placement Agent Warrants

We are offering up to 2,461,538145,020 shares of our Class A Common Stock, (the “Classpar value $0.001 per share (“Class A common stock”) together with upissuable upon the exercise of certain warrants held by the Selling Stockholders (including shares that may be issued to 2,461,538 Class A common warrants to purchase up to 2,461,538the holder in lieu of fractional shares).

 shares

We are registering the offer and sale of Class A common stock (the “Class A common warrants”). Each shareon behalf of our Class A common stock, or a pre-funded warrant in lieu thereof, is being sold together with a Class A common warrantthe Selling Stockholders to purchase one share of our Class A common stock. The shares of Class A common stock and Class A common warrants are immediately separable and will be issued separately in this offering but must be purchased together in this offering. The assumed combined public offering price for each share of Class A common stock and accompanying Class A common warrant is $3.25, which is equalsatisfy certain registration rights that we have granted to the closing priceSelling Stockholders.

Each Selling Stockholder may, from time to time, sell, transfer, or otherwise dispose of ourany or all of the Class A common stock on the Nasdaq Capital Marketany stock exchange, market, or trading facility on March 28, 2024. Each Class A common warrant will have an exercise price per share of $            , will be exercisable upon issuance and have a term of five (5) years from the date of issuance.

We are also offering to each purchaser whose purchase ofwhich shares of our Class A common stock are traded or in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or,private transactions. These dispositions may be at fixed prices, at prevailing market prices at the electiontime of sale, at prices related to the holder, 9.99%)prevailing market price, at varying prices determined at the time of our outstanding shares of Class A common stock immediately following consummation of this offering,sale, or at negotiated prices. The Selling Stockholders will bear all commissions and discounts, if any, attributable to the opportunity to purchase, if the purchaser so chooses, pre-funded warrants (the “pre-funded warrants”) to purchase shares of Class A common stock, or the pre-funded warrants, in lieu of sharessales of Class A common stock. Each pre-funded warrantWe will be exercisable for one sharebear all other costs, expenses, and fees in connection with the registration of ourthe Class A common stock. The purchase priceSee “Plan of each pre-funded warrant and accompanying Class A common warrant will equal the price per shareDistribution” section of Class A common stock and accompanying Class A common warrant being sold to the public in this prospectus.

We are not offering minus $0.001, and the exercise price of each pre-funded warrant will be $0.001 per share. For each pre-funded warrant that we sell, the number ofany shares of our Class A common stock that we are offeringfor sale under this prospectus. We will be decreased on a one-for-one basis. This offering also relates tonot receive any of the sharesproceeds from the sale or other disposition of our Class A common stock issuable upon exerciseby the Selling Stockholders. However, we may receive proceeds of up to approximately $2.4 million if all of the Class A common warrants andWarrants covered by this prospectus are exercised for cash, based on the pre-funded warrants.

This offering will terminate on May 15, 2024, unless we decide to terminate the offering (which we may do at any time in our discretion) prior to that date. We will have one closing for all the securities purchased in this offering. The combined public offering price per share (or pre-funded warrant) and Class A common warrant will be fixed forexercise price of the duration of this offering.

On March 26, 2024, we amended our Certificate of Incorporation to effectwarrants held by the Reverse Split. All share and per share data, option numbers, warrant numbers, and other derivative security numbers and exercise prices in this prospectus give effect to the Reverse Split. Our Annual Report on Form 10Selling Stockholders.

-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on February 27, 2024, as amended on Form 10

-K/A and filed with the SEC on March 11, 2024, and all other information and documents incorporated by reference into this prospectus that were filed prior to March 19, 2024, do not give effect to the Reverse Split.

Our Class A common stock is listedtraded on the NasdaqNASDAQ Capital Market under the symbol “LGVN.” The“LGVN”. On April 9, 2024, the last reported sale price offor our Class A common stock on the Nasdaq Capital Market on April 2, 2024, was $2.75 per share. All share, Class A common warrant and pre-funded warrant numbers are based on an assumed combined public offering price of $3.25 per share and the accompanying Class A common warrant and $3.249 per pre-funded warrant and the accompanying Class A common warrant, based on the Company’s closing price of the Class A common stock on March28, 2024 as reported on the Nasdaq

NASDAQ Capital Market. The actual combined public offering priceMarket was $2.15 per share of Class A common(which reflects the one-for-ten reverse stock and accompanying Class A common warrant, and per pre-funded warrant and accompanying Class A common warrant, will be determined between us and investors based on market conditions at thesplit with an effective time of pricing, and may be at a discount to the then current market price of our Class A common stock. The recent market price used throughout this prospectus may not be indicative of the actual combined public offering price. The actual combined public offering price may be based upon a number of factors, including our history and our prospects, the industry in which we operate, our past and present operating results, the previous experience of our executive officers and the general condition of the securities markets at the time of this offering. There is no established public trading market for the Class A common warrants or pre-funded warrants, and we do not expect a market for the Class A common warrants or the pre-funded warrants to develop. We do not intend to list the Class A common warrants or pre-funded warrants11:59 p.m. Eastern Time on the Nasdaq Capital Market, any other national securities exchange or any other trading system. Without an active trading market, the liquidity of the Class A common warrants and the pre-fundedMarch 26, 2024.) warrants will be limited.

We have engaged H.C. Wainwright & Co., LLC (the “placement agent”), to act as our exclusive placement agent in connection with this offering. The placement agent has agreed to use its reasonable best efforts to arrange for the sale of the securities offered by this prospectus. The placement agent is not purchasing or selling any of the securities we are offering, and the placement agent is not required to arrange the purchase or sale of any specific number or dollar amount of securities. We have agreed to pay to the placement agent the placement agent fees set forth in the table below, which assumes that we sell all of the securities offered by this prospectus. Since we will deliver the securities to be issued in this offering upon our receipt of investor funds, there is no arrangement for funds to be received in escrow, trust or similar arrangement. There is no minimum offering requirement as a condition of closing of this offering. Because there is no minimum offering amount required as a condition to closing this offering, we may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us. Investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to pursue our business goals described in this prospectus. In addition, because there is no escrow account and no minimum offering amount, investors could be in a position where they have invested in our company, but we are unable to fulfill all of our contemplated objectives due to a lack of interest in this offering. We will bear all costs associated with the offering. See “Plan of Distribution” on page 35 of this prospectus for more information regarding these arrangements.

We are an “emerging growth company” under the federal securities laws and, as such, we have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings. See “Prospectus Summary — Implication of Being an Emerging Growth Company and a Smaller Reporting Company.”

____________

(1) We have agreed to pay the placement agent a cash fee equal to 7.0% of the gross proceeds raised in this offering. We have also agreed to reimburse the placement agent for certain of its offering-related expenses, including a management fee equal to 1.0% of the aggregate gross proceeds raised in this offering, reimbursement for non-accountable expenses in an amount up to $35,000, and legal fees and other out-of-pocket expenses in the amount of up to $100,000. In addition, we have agreed to issue to the placement agent or its designees warrants (the “Placement Agent Warrants”) to purchase a number of shares of Class A common stock equal to 7.0% of the shares of Class A common stock sold in this offering (including the shares of Class A common stock issuable upon exercise of the pre-funded warrants), at an exercise price of $            per share, which represents 125% of the combined public offering price per share and accompanying Class A common warrant. See “Plan of Distribution” on page 35 of this prospectus for a description of the fees and expenses to be paid to the placement agent for services performed in connection with the offering.

__________________________________________

Investing in our securities involves a high degree of risk.See “Risk Factors” beginning on page 14 Before making any investment in these securities, you should consider carefully the risks and uncertainties in the “Risk Factors” section of this prospectus as well asand in the risk factors and other information in any documents we incorporatethat are incorporated by reference into this prospectus, to read about important factors you should consider.reference.

Neither the Securities and Exchange Commission (the “SEC”) nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

The delivery to purchasers of the shares of Class A common stock, pre-funded warrants and Class A common warrants in this offering is expected to be made on or about April            , 2024, subject to satisfaction of certain customary closing conditions.

H.C. Wainwright & Co.

The date of this prospectus is                      April, 2024

 , 2024

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Neither we nor the placement agent have authorized anyone to provide

ABOUT THIS PROSPECTUS

This prospectus provides you with a general description of the Class A common stock that may be resold by the Selling Stockholders. In certain circumstances, we may provide a prospectus supplement that will contain specific information other thanabout the terms of a particular offering by the Selling Stockholders. We also may provide a prospectus supplement to add information to, or update or change information contained in, this prospectus. To the extent there is a conflict between the information contained in this prospectus and any prospectus supplement, you should rely on the information in the prospectus supplement, provided that containedif any statement in one of these documents is inconsistent with a statement in another document having a later date — for example, a document incorporated by reference in this prospectus or any free writing prospectus prepared by or on our behalf or to which we have referred you. We andsupplement — the placement agent take no responsibility for and can provide no assurance as to the reliability of, any other information that others may give you. We and the placement agent are offering to sell, and seeking offers to buy, securities only in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date on the front cover page of this prospectus, or other earlier date stated in this prospectus, regardless of the time of delivery of this prospectus or of any sale of our securities. Our business, financial condition, results of operations and future prospects may have changed since that date.

No action is being taken in any jurisdiction outside the United States to permit a public offering of our securities or possession or distribution of this prospectus in that jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of this prospectus applicable to that jurisdiction.

We and the placement agent are offering to sell, and seeking offers to buy, our securities only in jurisdictions where offers and sales are permitted. Neither we nor the placement agent have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other thanstatement in the United States. Persons outside oflater-dated document modifies or supersedes the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of our shares of Class A common stock, Class A common warrants and preearlier statement.-funded

 warrants and the distribution of this prospectus outside of the United States.

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About This Prospectus

This prospectus is part of a registration statement that we have filed with the Securities and Exchange Commission.Commission pursuant to which the Selling Stockholders named herein may, from time to time, offer and sell or otherwise dispose of the Class A common stock covered by this prospectus. You should rely only on the information contained in this prospectus or any related prospectus supplement. We have not authorized anyone to provide you with different information. If anyone provides you with different or inconsistent information, you should not rely on it. The information contained in this prospectus is accurate only on the date of this prospectus. Our business, financial condition, results of operations and prospects may have changed since such date. Other than as required under the federal securities laws, we undertake no obligation to publicly update or revise such information, whether as a result of new information, future events or any other reason. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed, or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below. You should read this prospectus in its entirety before making an investment decision. You should also read and consider the information in the documents to which we have referred you in the section of the prospectus entitled “Where You Can Find More Information.”

This prospectus does not constitute an offer to sell or the solicitation of an offer to buy any of our securities other than the securitiesClass A common stock covered hereby, nor does this prospectus constitute an offer to sell or the solicitation of an offer to buy any securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about, and to observe, any restrictions as to the offering and the distribution of this prospectus applicable to those jurisdictions.

Industry and Market Data

This prospectus includes industry data and forecasts that we obtained from industry publications and surveys, public filings and internal company sources. Industry publications and surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but there can be no assurance as to the accuracy or completeness of the included information. Statements as to our market position and market estimates are based on independent industry publications, government publications, third party forecasts, management’s estimates and assumptions about our markets and our internal research. While we are not aware of any misstatements regarding the market, industry or similar data presented herein, such data involve risks and uncertainties and are subject to change based on various factors, including those discussed under the headings “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in this prospectus.

This prospectus contains references to trademarks, trade names and service marks belonging to other entities. Solely for convenience, trademarks, trade names and service marks referred to in this prospectus may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that the applicable licensor will not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names. We do not intend our use or display of other companies’ trade names, trademarks, or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

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PROSPECTUS SUMMARY

This summary highlights, and is qualified in its entirety by, the more detailed information and financial statements included elsewhere or incorporated by reference in this prospectus. This summary does not contain all of the information that may be important to you in making your investment decision. You should read this entire prospectus carefully, especially the “Risk Factors” section beginning on page 14,of this prospectus as well as “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Risk Factors” and our audited financial statements, unaudited financial statements and related notes thereto, which are incorporated by reference into this prospectus. In this prospectus, except as otherwise indicated, “Longeveron,” the “Company,” “we,” “our,” and “us” refer to Longeveron Inc., a Delaware corporation.

Business Overview

We are a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™Lomecel-B™, an allogeneic Mesenchymal Stem Cell (“MSC”) formulation sourced from the bone marrow of young, healthy adult donors. Lomecel-B™Lomecel-B™ has multiple potential mechanisms of action that promote tissue repair and healing with broad potential applications across a spectrum of disease areas. The underlying mechanism(s) of action that may lead to the tissue repair programs include the stimulation of new blood vessel formation, modulation of the immune system, reduction in tissue fibrosis, and the stimulation of endogenous cells to divide and increase the numbers of certain specialized cells in the body.

We currently have three pipeline indications: Hypoplastic Left Heart Syndrome (“HLHS”), Alzheimer’s disease (“AD”) and Aging-relatedAging-related Frailty. Our mission is to advance Lomecel-B™Lomecel-B™ and other cell-basedcell-based product candidates into pivotal or Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization, and broad use by the healthcare community.

In November of 2023, Longeveron received notice from the World Health Organization (“WHO”) that “Laromestrocel” has been selected as the proposed International Nonproprietary Name for Longeveron’s Lomecel-B™Lomecel-B™ product.  Assuming that there are no third-partythird-party objections to that name, the name will be recommended for adoption by the WHO.  Longeveron plans to adopt that name if it is recommended by the WHO.

HLHS

HLHS

Our HLHS program is focused on the potential clinical benefits of Lomecel-B™Lomecel-B™ as an adjunct therapeutic to standard-of-carestandard-of-care HLHS surgery. HLHS is a rare and devastating congenital heart defect in which the left ventricle is severely underdeveloped. As such, babies born with this condition die shortly after birth without undergoing a complex series of reconstructive heart surgeries. Despite the availability of life-savinglife-saving surgical interventions, clinical studies show that only 50 to 60 percent of affected individuals survive to adolescence. Early clinical study data shows the potential survival benefit of Lomecel-B™Lomecel-B™ for HLHS patients and supports Longeveron’s belief that this data shows the potential to alter the treatment landscape for patients with HLHS. We have completed a Phase 1 open-labelopen-label study (“ELPIS I”)¹ that supported the safety and tolerability of Lomecel-B™Lomecel-B™ for HLHS, when directly injected into the functional right ventricle during the second-stage standard-of-caresecond-stage standard-of-care surgery (adding minimal additional time to the surgical procedure). Preliminary data revealed that several indices of right ventricular function show suggestions of either improvement or prevention of deterioration over one year following surgery. Heart transplant-freetransplant-free survival for patients who received Lomecel-B™Lomecel-B™ intracardiac injection is favorable as compared to historical controls for survival. The improvement in HLHS survival following the Phase 1 ELPIS I clinical trial resulted in acceptance by the American Heart Association (“AHA”) for a poster presentation of the data at an AHA meeting in November 2023.

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1 Sunjay Kaushal, MD, PhD, Joshua M Hare, MD, Jessica R Hoffman, PhD, Riley M Boyd, BA, Kevin N Ramdas, MD, MPH, Nicholas Pietris, MD, Shelby Kutty, MD, PhD, MS, James S Tweddell, MD, S Adil Husain, MD, Shaji C Menon, MBBS, MD, MS, Linda M Lambert, MSN-cFNP, David A Danford, MD, Seth J Kligerman, MD, Narutoshi Hibino, MD, PhD, Laxminarayana Korutla, PhD, Prashanth Vallabhajosyula, MD, MS, Michael J Campbell, MD, Aisha Khan, PhD, Eric Naioti, MSPH, Keyvan Yousefi, PharmD, PhD, Danial Mehranfard, PharmD, MBA, Lisa McClain-Moss, Anthony A Oliva, PhD, Michael E Davis, PhD, Intramyocardial cell-based therapy with Lomecel-B™ during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: The ELPIS phase I trial, European Heart Journal Open, 2023.

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The ELPIS I trial showed 100 percent survival in children at up to 5 years of age after receiving Lomecel-B™Lomecel-B™, compared to a 20 percent mortality rate observed from historical control data. Based on these findings, the U.S. Food and Drug Administration (the “FDA”) granted Lomecel-B™Lomecel-B™ both Rare Pediatric Disease (“RPD”) Designation and Orphan Drug Designation (“ODD”) for treatment of infants with HLHS. The FDA also granted Fast Track Designation for Lomecel-B™Lomecel-B™ for HLHS. Longeveron is currently conducting a controlled Phase 2 trial (“ELPIS II”) to compare the effects of Lomecel-B™Lomecel-B™ as an adjunct therapeutic versus standard-of-carestandard-of-care (HLHS surgery alone). We hope that a positive outcome could add to the clinical data suggesting the functional and clinical benefit of Lomecel-B™Lomecel-B™ as part of standard-of-carestandard-of-care treatment in HLHS patients.

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Sunjay Kaushal, MD, PhD, Joshua M Hare, MD, Jessica R Hoffman, PhD, Riley M Boyd, BA, Kevin N Ramdas, MD, MPH, Nicholas Pietris, MD, Shelby Kutty, MD, PhD, MS, James S Tweddell, MD, S Adil Husain, MD, Shaji C Menon, MBBS, MD, MS, Linda M Lambert, MSN-cFNP, David A Danford, MD, Seth J Kligerman, MD, Narutoshi Hibino, MD, PhD, Laxminarayana Korutla, PhD, Prashanth Vallabhajosyula, MD, MS, Michael J Campbell, MD, Aisha Khan, PhD, Eric Naioti, MSPH, Keyvan Yousefi, PharmD, PhD, Danial Mehranfard, PharmD, MBA, Lisa McClain-Moss, Anthony A Oliva, PhD, Michael E Davis, PhD, Intramyocardial cell-based therapy with Lomecel-B™ during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: The ELPIS phase I trial, European Heart Journal Open, 2023.

Alzheimer’s Disease

In September 2023, we completed our Phase 2a AD clinical trial, known as the CLEAR MIND trial. This trial enrolled patients with mild Alzheimer’s disease and was designed as a randomized, double-blind, placebo-controlleddouble-blind, placebo-controlled study across ten U.S. centers. Our primary objective was to assess safety, and we tested three distinct Lomecel-BLomecel-B^TM dosing regimens against a placebo.

The study demonstrated positive results. Notably, all Lomecel-B™Lomecel-B™ treatment groups met the safety primary endpoint and showed slowing/prevention of disease worsening relative to placebo. There were statistically significant improvements in the secondary efficacy endpoint, composite Alzheimer’s disease score (“CADS”), for both the low-dose Lomecel-Blow-dose Lomecel-B^TMgroup and the pooled treatment groups compared to placebo. Other doses also indicated promising results in slowing/prevention of disease worsening.worsening Additionally, a statistically significant improvement versus placebo was observed in the cognitive assessment (“MoCA”) and in the activity of daily living observed by a caregiver and measured by Alzheimer’s Disease Cooperative Study Activities of Daily Living (“ADCS-ADL”ADCS-ADL”). These findings support both the safety and potential therapeutic benefit of Lomecel-BLomecel-B^TMin managing mild Alzheimer’s disease, and we believe lays the foundation for subsequent trials in this indication.

Aging-related Frailty

Improvement of the quality of life for the aging population is one of the strategic directions of the Company. Life expectancy has substantially increased over the past century due to medical and public health advancements. However, this longevity increase has not been paralleled by health span —– the period of time one can expect to live in relatively good health and independence. For many developed and developing countries, health span lags life-expectancylife-expectancy by over a decade. This has placed tremendous strain on healthcare systems in the management of aging-relatedaging-related ailments and presents additional socioeconomic consequences due to patient decreased independence and quality-of-life.quality-of-life. Since these strains continue to increase with demographic shifts towards an increasingly older population, improving health span has become a priority for health agencies, such as the National Institute on Aging (“NIA”) of the National Institutes of Health (“NIH”), the Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”), and the European Medicines Agency (“EMA”). As we age, we experience a decline in our own stem cells, a decrease in immune system function (known as “immunosenescence”), diminished blood vessel functioning, chronic inflammation (known as “inflammaging”), and other aging-relatedaging-related alterations that affect biological functioning. Our preliminary clinical data suggest that Lomecel-B™Lomecel-B™ may potentially address these problems through multiple potential mechanisms of action (“MOAs”) that simultaneously target key aging-relatedaging-related processes. We previously completed our Phase 2b trial in Aging-relatedAging-related Frailty and are continuing to use Lomecel-B™Lomecel-B™ in registry trials in The Bahamas, which we hope may be considered as part of the real-worldreal-world data generation for this indication.

Implication of Being an Emerging Growth Company and Smaller Reporting Company

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year following the fifth anniversary of the completion of our initial public offering, (2) the last day of the fiscal year in which we have total annual gross revenues of at least $1.235 billion, (3) the date on which we are deemed to be a “large accelerated filer” as defined in Rule 12b-212b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which would occur if the market value of our Class A common stock held by non-affiliatesnon-affiliates exceeded $700.0 million as of the last business day of our most recently completed second fiscal quarter or (4) the date on which we have issued more than $1.0 billion in non-convertiblenon-convertible debt securities during the prior three-yearthree-year period. An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging

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growth company, we may (i) reduce our executive compensation disclosure; (ii) present only two years of audited financial statements, plus unaudited condensed financial statements for any interim period, and correspondingly reduced Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure; (iii) avail ourselves of the exemption from the requirement to obtain an attestation and report from our auditors on‘on the assessment of our internal control over financial reporting pursuant to the Sarbanes-OxleySarbanes-Oxley Act of 2002; and (iv) not require stockholder non-bindingnon-binding advisory votes on executive compensation or golden parachute arrangements.

We have availed ourselves in this prospectus of the reduced reporting requirements described above. As a result, the information that we provide stockholders may be less comprehensive than what you might receive from other public companies. When we are no longer deemed to be an emerging growth company, we will not be entitled to the exemptions provided in the JOBS Act discussed above. We have elected to avail ourselves of the exemption that allows emerging growth companies to extend the transition period for complying with new or revised financial accounting standards. This election is irrevocable.

We are also currently a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our public float is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our public float is less than $700.0 million measured on the last business day of our second fiscal quarter. In the event that we are still considered a “smaller reporting company,” at such time as we cease being an “emerging growth company,” the disclosure we will be required to provide in our SEC filings will increase but will still be less than it would be if we were not considered either an “emerging growth company” or a “smaller reporting company.” Specifically, similar to “emerging growth companies,” “smaller reporting companies” are able to provide simplified executive compensation disclosures in their filings; are exempt from the provisions of Section 404(b) of the Sarbanes-OxleySarbanes-Oxley Act requiring that independent registered public accounting firms provide an attestation report on the effectiveness of internal control over financial reporting; and have certain other decreased disclosure obligations in their SEC filings, including, among other things, only being required to provide two years of audited financial statements in annual reports. Decreased disclosures in our SEC filings due to our status as an “emerging growth company” or “smaller reporting company” may make it harder for investors to analyze our results of operations and financial prospects.

Summary of Clinical Development Strategy

Our core strategy is to become a world-leadingworld-leading regenerative medicine company through the development, approval, and commercialization of novel cell therapy products for unmet medical needs, with a focus on HLHS. Key elements of our current business strategy are as follows.

•

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Execution of ELPIS II, a Phase 2 randomized controlled trial set forth in greater detail below, to measure the efficacy of Lomecel-B™ in HLHS. This trial is ongoing and is being conducted in collaboration with the National Heart, Lung, and Blood Institute (“NHLBI”) through grants from the NIH.

 Execution of ELPIS II, a Phase 2 randomized controlled trial set forth in greater detail below, to measure the efficacy of Lomecel-B™ in HLHS. This trial is ongoing and is being conducted in collaboration with the National Heart, Lung, and Blood Institute (“NHLBI”) through grants from the NIH.

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Continue to pursue the therapeutic potential of Lomecel-B™ in mild AD. We completed a Phase 2a trial, the (“CLEAR MIND Trial”), which demonstrated the potential benefits of Lomecel-B™ over placebo to maintain cognitive function and slow deterioration of brain structure atrophy, with no safety issues observed. Specifically, the safety primary endpoint was met across all study groups and the trial demonstrated a statistical significance in the second CADS endpoint. Overall, in Lomecel-B™ groups, brain magnetic resonance imaging (“MRI”) demonstrated whole brain volume loss slowed accompanied by  significant preservation of left hippocampal volume relative to placebo. We plan to continue to analyze the data in order to further develop our clinical development strategy. Our objective is to forge strategic collaborations for the advancement of Lomecel-B™ in addressing AD. We are actively in pursuit of a partnership to propel this initiative forward.

• Continue to pursue the therapeutic potential of Lomecel-B™ in mild AD. We completed a Phase 2a trial, the (“CLEAR MIND Trial”), which demonstrated the potential benefits of Lomecel-B™ over placebo to maintain cognitive function and slow deterioration of brain structure atrophy, with no safety issues observed. Specifically, the safety primary endpoint was met across all study groups and the trial demonstrated a statistical significance in the second CADS endpoint. Overall, in Lomecel-B™ groups, brain magnetic resonance imaging (“MRI”) demonstrated whole brain volume loss slowed accompanied by significant preservation of left hippocampal volume relative to placebo. We plan to continue to analyze the data in order to further develop our clinical development strategy. Our objective is to forge strategic collaborations for the advancement of Lomecel-B™ in addressing AD. We are actively in pursuit of a partnership to propel this initiative forward.

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Limited focus on our international program. In line with the Company’s strategic direction for 2024 and moving forward to focus on HLHS and AD as set forth previously, the Company has discontinued its clinical trial in Japan to evaluate Lomecel-B™ for Aging-related Frailty. The Company will continue to enroll patients on the Frailty and Cognitive Impairment registry trials in The Bahamas and plans to also launch an Osteoarthritis registry trial.

• 

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Expand our manufacturing capabilities.  We operate a current good manufacturing practice (“cGMP”)-compliant manufacturing facility and produce our own product candidates for testing. We continue to improve and expand our capabilities with the goal of achieving cost-effective manufacturing that may potentially satisfy future commercial demand for potential Lomecel-B™ commercialization for our primary indication, HLHS.

Limited focus on our international program. In line with the Company’s strategic direction for 2024 and moving forward to focus on HLHS and AD as set forth previously, the Company has discontinued its clinical trial in Japan to evaluate Lomecel

●

Collaborative arrangements and out-licensing opportunities. We will be opportunistic and consider entering into co-development, out-licensing, or other collaboration agreements for the purpose of eventually commercializing Lomecel-B™ and other products domestically and internationally if appropriate approvals are obtained.

-B™ for Aging

●

Product candidate development pipeline through internal research and development, and in-licensing. Through our research and development program, and through strategic in-licensing agreements, or other business development arrangements, we intend to actively explore promising potential additions to our pipeline.

-related Frailty. The Company will continue to enroll patients on the Frailty and Cognitive Impairment registry trials in The Bahamas and plans to also launch an Osteoarthritis registry trial.

●

Continue to expand our intellectual property portfolio. Our intellectual property is vitally important to our business strategy, and we have taken and continue to take significant steps to develop this property and protect its value. Results from our ongoing research and development efforts are intended to add to our existing intellectual property portfolio.

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•Expand our manufacturing capabilities. We operate a current good manufacturing practice (“cGMP”)-compliant manufacturing facility and produce our own product candidates for testing. We continue to improve and expand our capabilities with the goal of achieving cost-effective manufacturing that may potentially satisfy future commercial demand for potential Lomecel-B™ commercialization for our primary indication, HLHS.

•Collaborative arrangements and out-licensing opportunities. We will be opportunistic and consider entering into co-development, out-licensing, or other collaboration agreements for the purpose of eventually commercializing Lomecel-B™ and other products domestically and internationally if appropriate approvals are obtained.

•Product candidate development pipeline through internal research and development, and in-licensing. Through our research and development program, and through strategic in-licensing agreements, or other business development arrangements, we intend to actively explore promising potential additions to our pipeline.

•Continue to expand our intellectual property portfolio. Our intellectual property is vitally important to our business strategy, and we have taken and continue to take significant steps to develop this property and protect its value. Results from our ongoing research and development efforts are intended to add to our existing intellectual property portfolio.

Clinical Development Pipeline in 2024

We are currently in clinical development of a single product, Lomecel-B™Lomecel-B™ for three potential indications:

Indication	Geography	Geography		Phase 1		Phase 2		Phase 3
HLHS	U.S.	HLHS			U.S.
Aging-related Frailty*	U.S.				U.S.
Alzheimer’s disease	U.S.				U.S.

Figure 1: Lomecel-B™Lomecel-B™ clinical development pipeline

____________

* 

*

Not currently active for 2024

Hypoplastic Left Heart Syndrome (HLHS). The FDA granted Lomecel-B™Lomecel-B™ for the treatment of HLHS a Rare Pediatric Disease (“RPD”) Designation (on November 8, 2021), Orphan Drug Designation (“ODD”) (on December 2, 2021), and Fast Track Designation (on August 24, 2022). HLHS is a rare congenital heart condition affecting approximately 1,000 newborns in the US annually. HLHS is a birth defect that affects normal blood flow through the heart. As the baby develops during pregnancy, the left side of the heart does not form correctly. It is one type of congenital heart defect present at birth. Because a baby with this defect needs surgery or other procedures soon after birth, HLHS is considered a critical congenital heart defect. To prevent certain death shortly after birth, these babies undergo a series of three heart surgeries (staged surgical palliation) that converts the normally 4-chamber4-chamber heart into a 3-chamber3-chamber one with a single ventricle (the right ventricle) supporting systemic circulation. Despite these life-savinglife-saving surgeries, HLHS patients nevertheless still have high early mortality and morbidity rates due primarily to heart failure.

We are currently conducting an ongoing Phase 2 clinical trial (ELPIS II) under FDA IND 017677. ELPIS II is a multi-center,multi-center, randomized, double-blind,double-blind, controlled clinical trial designed to evaluate Lomecel-B™Lomecel-B™ as an adjunct therapy to the standard-of-care second-stagestandard-of-care second-stage HLHS heart reconstructive surgery which is typically performed at 4-64-6 months after birth. The primary objective is to evaluate change in right ventricular ejection fraction after Lomecel-B™Lomecel-B™ treatment versus standard-of-carestandard-of-care surgery alone (38 subjects total: 19 per arm). This trial is over 50% enrolled and is funded in part by the NHLBI/NIH. While we cannot predict a specific time when the trial will be fully enrolled, the current plan is that enrollment will be completed in 2024.

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ELPIS II is a next-stepnext-step trial to our completed 10-patient open-label10-patient open-label Phase 1 trial (ELPIS I) under the same IND. This Phase 1 trial was designed to evaluate the safety and tolerability of Lomecel-B™Lomecel-B™ as an adjunct to the second-stagesecond-stage HLHS surgery, and to obtain preliminary evidence of Lomecel-B™Lomecel-B™ effect to support a next-phasenext-phase trial. The primary safety endpoint was met: no major adverse cardiac events (“MACE”) or treatment-relatedtreatment-related infections during the first month post-treatment,post-treatment, and no triggering of stopping rules. Furthermore, fluid-basedfluid-based and imaging biomarker data supported multiple potentially relevant mechanisms-of-actionmechanisms-of-action of Lomecel-B™Lomecel-B™, and the potential to improve post-surgicalpost-surgical heart function. In addition to the 12-month follow-up12-month follow-up evaluation on ELPIS, we continue to follow these patients on an annual basis. As of February 2024, all 10 patients have survived (100%), seven of the patients have reached the age of five and have successfully undergone the third-stagethird-stage surgery, and two of them have reached the age of six years old, all without the need for a heart transplantation. Based on historical data, over 15% of patients would be expected to have received a heart transplant or have died within three years after the second-stagesecond-stage surgery, rising to nearly 20% by five years. We intended to continue to follow-upfollow-up with these patients for up to an additional five years, until all patients reach ten years of age.

We are prosecuting a number of patent applications relating to the administration of mesenchymal stem cells for treating HLHS in Canada, Japan, Taiwan, the United States and the Bahamas, with applications having also been ordered for filing in Australia, China, South Korea, and the European Patent Office.

Alzheimer’s disease. AD, a devastating neurologic disease leading to cognitive decline, currently has very limited therapeutic options. An estimated 6.7 million Americans aged 65 and older have AD, and this number is projected to more than double by 2060. Lomecel-B™Lomecel-B™ treated patients showed an overall slowing/prevention of disease worsening compared to placebo in the completed Phase 2a study (CLEAR MIND) as previously detailed in this prospectus, and met its primary endpoint of safety. These results are consistent with those of our earlier Phase I study².  As previously indicated, we are actively in pursuit of a partnership to propel our AD initiative forward.

2

Mark Brody, Marc Agronin, Brad J. Herskowitz, Susan Y. Bookheimer, Gary W. Small, Benjamin Hitchinson, Kevin Ramdas, Tyler Wishard, Katalina Fernández McInerney, Bruno Vellas, Felipe Sierra, Zhijie Jiang, Lisa McClain-Moss, Carmen Perez, Ana Fuquay, Savannah Rodriguez, Joshua M. Hare, Anthony A. Oliva Jr., Bernard Baumel. “Results and insights from a phase I clinical trial of Lomecel-B™ for Alzheimer’s disease” (2023) Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association 19:261-273.

Aging-related Frailty. Aging-relatedAging-related Frailty is a life-threateninglife-threatening geriatric condition that disproportionately increases risks for poor clinical outcomes from disease and injury. While the definition of Aging-relatedAging-related Frailty lacks consensus, would be a new indication from a regulatory standpoint, and has no approved pharmaceutical or biologic treatments, there are a number of companies now working to develop potential therapeutics for this unmet medical need.

We have previously completed two U.S. clinical trials under FDA IND 016644. One is a multicenter, randomized, placebo-controlledplacebo-controlled Phase 2b trial which showed that a single infusion of Lomecel-B™Lomecel-B™ significantly improved 6-Minute6-Minute Walk Test (“6MWT”) distance 9 months after infusion (although results were inconclusive at six months after infusion), and also showed a dose-dependentdose-dependent increase in 6MWT distance 6 months after infusion. The second is a multicenter, randomized, placebo-controlledplacebo-controlled Phase 1/2 trial (“HERA Trial”) intended primarily to evaluate safety, and explore the effect Lomecel-B™Lomecel-B™ may have on specific biomarkers of immune system function in older, frail individuals receiving the high dose influenza vaccine, as well as to evaluate the potential effects of Lomecel-B™Lomecel-B™ on signs and symptoms of Aging Frailty. Results from this study showed that Lomecel-B™Lomecel-B™ was generally safe and well tolerated in patients with Aging-relatedAging-related Frailty. Additionally, hemagglutinin inhibition (“HAI”) assay results in the Lomecel-B™Lomecel-B™ and placebo groups to influenza were not statistically different, indicating Lomecel-B™Lomecel-B™ does not suppress the immune system.

Recent Developments

October 2023 Offering

On October 11, 2023, we entered into a securities purchase agreement with an institutional accredited investor relating to the registered direct offering and sale of an aggregate of 236,500shares of our Class A common stock, par value $0.001 per share and pre-fundedpre-funded warrants to purchase up to 5,925shares of Class A common stock at an exercise price of $0.001 per share, at a purchase price of $16.50 per share of Class A common stock and a purchase price of $16.49$16.499 per pre-fundedpre-funded warrant (the “October registered direct offering”). The equity issued in the October registered

____________

2Mark Brody, Marc Agronin, Brad J. Herskowitz, Susan Y. Bookheimer, Gary W. Small, Benjamin Hitchinson, Kevin Ramdas, Tyler Wishard, Katalina Fernández McInerney, Bruno Vellas, Felipe Sierra, Zhijie Jiang, Lisa McClain-Moss, Carmen Perez, Ana Fuquay, Savannah Rodriguez, Joshua M. Hare, Anthony A. Oliva Jr., Bernard Baumel. “Results and insights from a phase I clinical trial of Lomecel-B™ for Alzheimer’s disease” (2023) Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association 19:261-273.

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direct offering were offered by us pursuant to a prospectus supplement, dated October 11, 2023, and accompanying prospectus, in connection with a takedown from our shelf registration statement on Form S-3S-3 (File No. 333-264142)333-264142), which was declared effective by the SEC on April 14, 2022. On October 17, 2023, the pre-fundedpre-funded warrants were exercised in full and the pre-fundedpre-funded warrant shares were subsequently issued.

In a concurrent private placement, we also sold unregistered Series A warrants to purchase up to an aggregate of 242,425shares of our Class A common stock and unregistered Series B warrants to purchase up to an aggregate of 242,425shares of our Class A common stock (the “October private placement warrants”). The unregistered Series A warrants have an exercise price of $16.50 per share, became exercisable on December 26, 2023, which was the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the Series A warrants, and expire on April 13, 2029. The unregistered Series B warrants have an exercise price of $16.50 per share, became exercisable on December 26, 2023, and expire on April 14, 2025. The holder may not exercise any portion of the October private placement warrants to the extent they would own more than 4.99% of the Company’s outstanding Class A common stock immediately after exercise.

In

Pursuant to an engagement letter (the “Engagement Letter”) between the Company and H.C. Wainwright & Co. (“Wainwright” or the “placement agent”), in addition to cash fees, the placement agent in the offering received warrants to purchase up to 16,971shares of Class A common stock (the “October placement agent warrants”), which represented 7.0% of the aggregate number of shares of Class A common stock sold in the October registered direct offering. The October placement agent warrants have substantially the same terms as the October private placement warrants, except that the October placement agent warrants have an exercise price equal to $20.625, or 125% of the offering price per share of Class A common stock sold in the October registered direct offering and expire on October 11, 2028. In addition, under the terms of the engagement letter with the placement agent, upon any exercise for cash of any Series B warrants issued to investors in the October private placement, we will issue to the placement agent, within five (5) business days of our receipt of the exercise price for the Series B warrants, warrants to purchase 7.0% of the Series B warrants that have been exercised.

The shares of Class A common stock underlying the October private placement warrants and the October placement agent warrants were registered on a Form S-1S-1 resale registration statement declared effective November 21, 2023.

On April 8, 2024, the Company also entered into an agreement to amend the October private placement warrants to (i) reduce the Exercise Price (as defined therein) of the October private placement warrants to $2.35 per share from $16.50 per share and (ii) amend the expiration date of the Series A Warrants to five and one-half (5.5) years from April 10, 2024, and the Series B Warrants to eighteen (18) months from April 10, 2024, in each case for a payment by the holder of $0.125 per amended warrant, which became effective April 10, 2024.

December 2023 Offering

On December 20, 2023, we entered into a securities purchase agreement with an institutional accredited investor relating to the registered direct offering and sale of an aggregate of 135,531shares of our Class A common stock, par value $0.001 per share, at a purchase price of $17.45 per share of Class A common stock and associated warrant (the “December registered direct offering”). The equity issued in the December registered direct offering were offered by us pursuant to a prospectus supplement, dated October 11, 2023, and accompanying prospectus, in connection with a takedown from our shelf registration statement on Form S-3S-3 (File No. 333-264142)333-264142), which was declared effective by the SEC on April 14, 2022.

In a concurrent private placement (the “December private placement” and together with the December registered direct offering, the “December offering”), we also sold unregistered Class A common stock warrants to purchase up to an aggregate of 135,531shares of our Class A common stock (the “December private placement warrants”). The unregistered December private placement warrants have an exercise price of $16.20 per share, became exercisable on December 22, 2023, and expire on June 22, 2029.

In addition to cash fees, the placement agent in the offering also received warrants to purchase up to 9,489shares of Class A common stock (the “December placement agent warrants” and together with the December private placement warrants, the “December warrants”), which represented 7.0% of the aggregate number of shares of Class A common stock sold in the December registered direct offering. The December placement agent warrants have substantially the same terms as the December private placement warrants, except that the December placement agent warrants have an exercise price equal to $21.813, or 125% of the offering price per share of Class A common stock sold in the December registered direct offering, and expire on December 20, 2028.

Pursuant to the terms of the purchase agreement, we agreed that, as soon as practicable (and in any event within 45 calendar days of the date of the purchase agreement), we will file a registration statement on Form S-1S-1 providing for the resale by the purchaser of the shares issued and issuable upon exercise of the December warrants. We agreed to use commercially reasonable efforts to cause such registration statement to become effective within 120 days following the December 22, 2023 closing date and to keep such registration statement effective at all times until purchaser does not own any December private placement warrants or shares issuable upon exercise thereof.

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Reverse Split

On March 26, 2024, we effected the Reverse Split of our common stock. The Reverse Split reduced the aggregate number of outstanding shares of Class A common stock on a pre-reverse split basis from 10,342,760 to 1,034,283 on a post-reverse split basis, and the aggregate number of outstanding shares of Class B common stock from 14,839,993 on a pre-reverse split basis to 1,484,005 on a post-reverse split basis (subject to further adjustment due to the rounding up of fractional shares resulting from the Reverse Split). The number of authorized shares of the Company’s capital stock remains unchanged at 105,000,000shares, consisting of 84,295,000shares of Class A common stock, 15,705,000shares of Class B common stock and 5,000,000shares of preferred stock.

Unless otherwise noted, the share numbers, the per share numbers, option numbers, warrant numbers, other derivative security numbers and exercise prices appearing in this prospectus, including those as of dates prior to the completion of the Reverse Split, have been adjusted to give effect to the Reverse Split, however, our annual, periodic and current reports, and all other information and documents incorporated by reference into this prospectus that were filed prior to March 19, 2024, do not give effect to the Reverse Split.

Notice from Nasdaq

On March 4, 2024, we received a notice from Nasdaq that our Class A common stock did not meet the $1.00 minimum bid price required for continued listing on the Nasdaq Capital Market (the “Minimum Bid Price Requirement”). The receipt of this letter does not result in the immediate delisting of the Company’s Class A common stock and we have an initial period of 180 calendar days (the “Compliance Period”) to regain compliance with the Minimum Bid Requirement.Requirement

If, at any time during the Compliance Period the bid price closes at $1.00 or more per share for a minimum of 10 consecutive business days (subject to Staff’s discretion to increase the minimum period to up to 20 consecutive business days under certain conditions), the Staff would provide written notification to the Company that it again complies with the Minimum Bid Price Requirement and the Class A common stock will continue to be eligible for listing on the Nasdaq Capital Market unless other eligibility deficiencies exist. However, if our Class A common stock has a closing bid price of $0.10 or less for ten consecutive trading days during the Compliance Period, Nasdaq can issue a Staff Determination Letter, which, unless appealed, would subject our Class A common sharesstock to immediate suspension and delisting.

If the Company were to not regain compliance with the Minimum Bid Price Requirement by the end of the Compliance Period, the Company could be eligible for an additional 180 calendar day compliance period. To qualify, the Company would be required to meet the continued listing requirements for the market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and would need to provide written notice to Nasdaq of its intention to cure the deficiency during the additional compliance period.

If it appears to the Staff that the Company would not be able to cure the deficiency, the Staff will provide written notice to the Company that its Class A common stock will be subject to delisting. At that time, the Company can appeal the Staff’s delisting determination to a Nasdaq Hearing Panel (the “Panel”). The Company expects that its Class A common stock would remain listed pending the Panel’s decision. There can be no assurance that, if the Company did appeal the Staff’s delisting determination to the Panel, such appeal would be successful.

In the event of a delisting from the Nasdaq Capital Market, our Class A common stock would likely be traded in the over-the-counter inter-dealerover-the-counter inter-dealer quotation system, more commonly known as the OTC. OTC transactions involve risks in addition to those associated with transactions in securities traded on the securities exchanges, such as the Nasdaq Capital Market, or Exchange-listedExchange-listed stocks. Many OTC stocks trade less frequently and in smaller volumes than Exchange-listedExchange-listed stocks. Accordingly, our Class A common stock would be less liquid than it would be otherwise. Also, the prices of OTC stocks are often more volatile than Exchange-listedExchange-listed stocks. Additionally, many institutional investors are prohibited from investing in OTC stocks, and it might be more challenging to raise capital when needed.

Reverse Split

On March 26, 2024, we effected the Reverse Split of our common stock. The Reverse Split reduced the aggregate number of outstanding shares of Class A common stock on a pre-reverse split basis from 10,342,760 to 1,101,254 on a post-reverse split basis, and the aggregate number of outstanding shares of Class B common stock from 14,839,993 on a pre-reverse split basis to 1,484,005 on a post-reverse split basis (subject to further adjustment due to the rounding up of fractional shares resulting from the Reverse Split). The number of authorized shares of the Company’s capital stock remains unchanged at 105,000,000 shares, consisting of 84,295,000 shares of Class A common stock, 15,705,000 shares of Class B common stock and 5,000,000 shares of preferred stock.

Unless otherwise noted, the share numbers, the per share numbers, option numbers, warrant numbers, other derivative security numbers and exercise prices appearing in this prospectus, including those as of dates prior to the completion of the Reverse Split, have been adjusted to give effect to the Reverse Split, however, our annual, periodic and current reports, and all other information and documents incorporated by reference into this prospectus that were filed prior to March 19, 2024, do not give effect to the Reverse Split.

April 2024 Offering

On April 8, 2024, we commenced a public offering (the “April offering”) of (i) 661,149 shares of Class A common stock and (ii) pre-funded warrants to purchase up to an aggregate 1,572,894 shares of Class A common stock (the “April pre-funded warrants”), which closed on April 10, 2024. The Class A common stock and April pre-funded warrants were sold together with warrants to purchase up to an aggregate of 2,234,043 shares of Class A common stock (the “April common warrants”). Certain institutional investors purchasing securities as part of the April offering entered into a securities purchase agreement with the Company dated as of April 8, 2024. The combined public offering price was $2.35 per share of Class A common stock and related April common warrant and $2.349 per April pre-funded warrant and related March common warrant.

The securities issued in the April offering were offered by us pursuant to a prospectus included in our registration statement on Form S-1 (File No. 333-278073), which was declared effective by the SEC on April 8, 2024. The April offering closed on April 10, 2024.

Subject to certain limitations described in the April common warrants, the April common warrants are immediately exercisable at an exercise price of $2.35 per share of Class A common stock and expire five years from the date of issuance. Subject to certain limitations described in the April pre-funded warrants, the April pre-funded warrants are immediately exercisable and may be exercised at a nominal consideration of $0.001 per share of Class A common stock at any time until all of the April pre-funded warrants are exercised in full.

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Concurrently with the closing of the April offering, certain purchasers elected to exercise April pre-funded warrants to purchase 1,318,362 shares of Class A common stock.

Pursuant to an engagement letter between the Company and Wainwright, the Company paid Wainwright a cash fee equal to 7.0% of the aggregate gross proceeds raised in the April offering, plus a management fee equal to 1.0% of the aggregate gross proceeds raised in the April offering and certain expenses incurred in connection with the April offering. The Company also issued to designees of Wainwright warrants to purchase up to 154,894 shares of Class A common stock (the “April placement agent warrants”). The April placement agent warrants have substantially the same terms as the April common warrants, except that the April placement agent warrants have an exercise price equal to $2.9375 per share and have a term of five years from the commencement of sales in the April offering.

In connection with the April offering, the Company agreed with a holder of October private placement warrants to amend those warrants in consideration for the holder’s participation in the April offering. The holder’s October private placement warrants to purchase up to (a) 242,425 shares of common stock at an exercise price of $16.50 per share, issued on October 13, 2023 and expiring on April 13, 2029 (the “Series A Warrants”) and (b) 242,425 shares of common stock at an exercise price of $16.50 per share, issued on October 13, 2023 and expiring on April 14, 2025 (the “Series B Warrants”) were amended to (i) reduce the exercise price of the October private placement warrants to $2.35 per share and (ii) amend the expiration date of the Series A Warrants to five and one-half (5.5) years following the closing of the April offering and the Series B Warrants to eighteen (18) months following the closing of the April offering, in each case for a payment to the Company of $0.125 per amended warrant, for aggregate gross consideration of $60,606.25, prior to deducting the Placement Agent’s fees.

Risks of Investing

Investing in our securities involves substantial risks. Potential investors are urged to read and consider the risk factors relating to an investment in the offered securities set forth under “Risk Factors” in this prospectus as well as other information we incorporate or include in this prospectus.

Corporate Information

We were initially formed as a Delaware limited liability company in October 2014. As part of our initial public offering (“IPO”) in February 2021, Longeveron LLC converted into a Delaware corporation pursuant to a statutory conversion, and changed its name to Longeveron Inc. Additional information about us is included in documents incorporated by reference in this prospectus. See “Where You Can Find More Information” and “Incorporation of Certain Information by Reference.” Our principal executive offices are located at 1951 NW 7th7th Avenue, Suite 520, Miami, Florida 33136, and our telephone number is (305) 909-0840.909-0840. Our website address is www.longeveron.com.www.longeveron.com. The information contained in, or accessible through, our website does not constitute a part of this prospectus. We have included our website address in this prospectus solely as an inactive textual reference.

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THE OFFERING

Common stock offered by us Issuer		Up to 2,461,538Longeveron Inc.
shares of our Class A common stock and Class A common warrants to purchase up to 2,461,538		shares of Class A common stock, or pre
-fundedSecurities Offered by Selling Stockholders:7 warrants to purchase shares of Class A common stock and Class A common warrants to purchase shares of Class A common stock. The shares of Class A common stock (or pre	-funded warrants to purchase shares of Class A common stock, as applicable) and Class A common warrants	We are immediately separable and will be issued separatelyregistering the resale by the Selling Stockholders named in this offering but must initially be purchased together in this offering. Each Class A common warrant hasprospectus, or their pledgees, assignees, distributees and successors-in-interest of an exercise priceaggregate of $            per share of Class A common stock, will be exercisable upon issuance and will expire            , 20            . We are also registering up to 5,095,384145,020 shares of Class A common stock issuable upon exercise of the Class A commonDecember warrants pre-fundedheld by the Selling Stockholders, of which (i) up to 135,531 shares are issuable upon the exercise of the December private placement warrants issued to the Purchaser upon the closing of the December private placement; and (ii) 9,489 shares are issuable upon exercise of the Placement Agent WarrantsDecember placement agent warrants issued to Wainwright, or its designees, pursuant to this prospectus. the terms of the Engagement Letter.
Pre-funded warrants offered by us		We are also offering to those purchasers, if any, whose purchase
Shares of the Class A common stock inOutstanding Prior to this offering would result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or at the election of the purchaser, 9.99%) of our outstanding Class A common stock immediately following consummation of this offering, the opportunity to purchase, if they so choose, pre-fundedOffering: warrants in lieu of the Class A common stock that would otherwise result in ownership in excess of 4.99% (or 9.99%, as applicable) of our outstanding Class A common stock.
		The purchase price of each pre-funded warrant and accompanying Class A common warrant will equal the price per share3,314,020 shares of Class A common stock and accompanying1,484,005 shares of Class B Common Stock, after rounding up of fractional shares resulting from the Reverse Split (assuming none of the December warrants are exercised).
Shares of Class A common warrant being sold tostock Outstanding assuming exercise of December warrants (1):		3,459,040 shares, after rounding up of fractional shares resulting from the publicReverse Split.
Shares of Class B common stock Outstanding		1,484,005 shares, after rounding up of fractional shares resulting from the Reverse Split.
Terms of the Offering		The Selling Stockholders will determine when and how they will sell the Class A common stock offered in this offering, minus $0.001, andprospectus, as described in the exercise price of each pre-funded warrant will be $0.001 per share.
		Each pre-funded warrant will be immediately exercisable and may be exercised at any time until exercised in full. There is no expiration date for the pre-funded warrants. To better understand the terms of the pre-funded warrants, you should carefully read the “Description of Securities We Are Offering” section of this prospectus. You should also read the formprospectus titled “Plan of pre-fundedDistribution.” warrant, which is filed as an exhibit to the registration statement that includes this prospectus.
Use of Proceeds:		The Selling Stockholders will receive the proceeds from the sale of the shares of Class A common stock offered hereby. We will not receive any proceeds from the sale of the shares of Class A common stock. However, we may receive proceeds in the aggregate amount of up to approximately $2.4 million if all of the December warrants are exercised for cash. See the “Use of Proceeds” section of this prospectus.

Voting Rights:		Shares of Class A common stock are entitled to be offered by us		Each shareone (1) vote per share. Shares of Class B common stock are entitled to five (5) votes per share. Holders of our Class A common stock and each pre-funded warrant to purchaseClass B common stock generally vote together as a single class, unless otherwise required by law or our certificate of incorporation (the “Certificate of Incorporation”). Each share of our Class B common stock is convertible into one share of our Class A common stock is being sold together with aat any time and converts automatically upon certain transfers. The Class A common warrantstock is not convertible into Class B common stock.
Dividend Policy:		We have never declared or paid any dividends to purchase one sharethe holders of our Class A common stock. Eachstock, and we do not expect to pay cash dividends in the foreseeable future. We currently intend to retain any earnings for use in connection with the operation of our business and for general corporate purposes.
Risk Factors:		Since our inception, we have incurred substantial losses. We will need additional funding (including the funding which may be received pursuant to a cash exercise of all the Warrants described in this prospectus) to remain a going concern, maintain operations, and to continue our current and planned clinical trial activity. Our business and our ability to execute our business strategy are subject to a number of risks of which you should be aware before you decide to buy our securities. In particular, you should carefully consider all of the risks which are discussed more fully in “Risk Factors” section of this prospectus and those incorporated by reference from our filings with the SEC.

Nasdaq Capital Market Symbol:

LGVN

(1)

The number of shares of Class A common warrant will have an exercise price of $            per share (representing            % of the price at which a share of common stock and accompanying Class A common warrant are sold to the public inbe outstanding after this offering), will be immediately exercisable and will expireoffering is based on the fifth (5th) anniversary of the original issuance date.

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The3,314,020 shares of Class A common stock and pre-funded warrants,1,484,005 shares of Class B common stock outstanding as of April 10, 2024 (as adjusted for the Reverse Split and the accompanying Class A common warrants,subject to adjustment based on issuances of additional shares as the case may be, can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. This prospectus also relatesapplicable due to the offeringrounding up of fractional shares resulting from the Reverse Split), and excludes:

	●	5,536 shares of Class A common stock issuable upon exercise of the Class A common warrants. Because we will issue a Class A common warrant for each shareoutstanding warrants at an exercise price of our Class A common stock and for each pre-funded$120.00 per share; Warrant sold in this offering, the number of Class A common warrants sold in this offering will not change as a result of a change in the mix of the shares of our Class A common stock and pre-funded Warrants sold.

Common stock to be outstanding after this offering(1)

3,495,821 

●

116,935 shares of Class A common stock assuming no sale of any pre-funded warrants and noissuable upon exercise of the Class A commonoutstanding warrants being offered in this offering and 1,484,005at an exercise price of $52.50 per share;

shares of Class B common stock. To the extent pre	-funded● warrants are sold, the number of	4,679 shares of Class A common stock sold in this offering will be reduced onissuable upon exercise of outstanding stock options at a one-for-one basis.
Use of Proceeds		We estimate that the net proceeds of this offering based upon an assumed combined public offeringweighted average exercise price of $3.25$175.00 per share and accompanying Class A common warrant, which was the closing price of our Class A common stock on the Nasdaq Capital Market on Marchshare;

28, 2024, after deducting placement agent fees and estimated offering expenses, will be approximately $7.0

●million, assuming we sell only

484,850 shares of Class A common stock and no pre-funded warrants and assuming noissuable upon exercise of outstanding October private placement warrants at an exercise price of $2.35 per share, pursuant to the Warrant Amendment dated April 8, 2024;

●

16,971 shares of Class A common warrants.stock issuable upon exercise of outstanding October placement agent warrants at an exercise price of $20.625 per share;

●

135,531 shares of Class A common stock issuable upon the exercise of outstanding December private placement warrants at an exercise price of $16.20 per share;

	●	9,489 shares of Class A common stock issuable upon the exercise of outstanding December placement agent warrants at an exercise price of $21.813 per share;
		We are conducting this offering to provide funding for our ongoing clinical and regulatory development of Lomecel-B™ for the treatment of several disease states and indications, including HLHS and Alzheimer’s disease, obtaining regulatory approvals, capital expenditures, working capital and other general corporate purposes. See “Use of Proceeds” for a more detailed description of the intended use of proceeds from this offering.
Nasdaq Capital Market Symbol for	●	2,212,766 shares of Class A common stock issuable upon the exercise of outstanding April private placement warrants at an exercise price of $2.35 per share;
		LGVN We do not intend to apply for the listing
	●	254,532 shares of the pre-funded warrants or Class A common stock issuable upon the exercise of outstanding April pre-funded warrants on any national securities exchange or other trading system. Withoutat an active trading market, the liquidityexercise price of the pre$0.001 per share;
-funded warrants and	●	154,894 shares of Class A common warrants will be limited.
Lock-up Agreements		The Company and our directors and officers have agreed withstock issuable upon the exercise of outstanding April placement agent subject to certain exceptions, not to sell, transfer or disposewarrants at an exercise price of directly or indirectly, any of our common stock or securities convertible into or exercisable or exchangeable for our common stock for a period of thirty (30) days after the closing of this offering. See “Plan of Distribution” for more information.
Risk Factors		Investing in our securities involves a high degree of risk. See “Risk Factors” for important information. $2.9375 per share;

____________

(1) The number of shares of common stock to be outstanding after this offering is based on 1,034,283

●

6,183 shares issuable upon the vesting of Restricted Stock Units (RSUs) under the Company’s 2021 Plan;

 shares of Class A common stock and 1,484,005

●

42,200 stock options outstanding with an average exercise price of $48.61 per share, issuable under the Company’s 2021 Plan.

 shares of Class B common stock outstanding as of March 28, 2024 as adjusted for the Reverse Split (and subject to further adjustment due to the rounding up of fractional shares resulting from the Reverse Split), and excludes:

•any shares of Class A common stock issuable upon conversion of existing Class B common stock;

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RISK FACTORS

Investing in our securities involves a high degree of risk. You should consider and read carefully all of the risks and uncertainties described below, as well as risk factors and other information contained in this prospectus and which is incorporated by reference in our most recent Annual Report on Form 10-K,10-K before making an investment decision with respect to our securities. The occurrence of any of the following risks or those incorporated by reference, or additional risks and uncertainties not presently known to us or that we currently believe to be immaterial could materially and adversely affect our business, financial condition, results of operations or cash flows. In any such case, the market price of our Class A common stock could decline, and you could lose all or part of your investment. This prospectus also contains forward-lookingforward-looking statements and estimates that involve risks and uncertainties. See “Cautionary Note Regarding Forward-LookingForward-Looking Statements.” Our actual results could differ materially and adversely from those anticipated in these forward-lookingforward-looking statements as a result of certain factors, including the risks and uncertainties described below and those incorporated by reference.

Risks Related to This Offering

Purchasers who purchase our securities in this offering pursuant to a securities purchase agreement may have rights not available to purchasers that purchase without the benefit of a securities purchase agreement.

In addition to rights and remedies available to all purchasers in this offering under federal securities and state law, the purchasers that enter into a securities purchase agreement will also be able to bring claims of breach of contract against us. The ability to pursue a claim for breach of contract provides those investors with the means to enforce the covenants uniquely available to them under the securities purchase agreement including: (i) timely delivery of shares; (ii) agreement to not enter into variable rate financings for one (1) year from closing, subject to certain exceptions; (iii) agreement to not enter into any financings for thirty (30) days from closing; and (iv) indemnification for breach of contract.

This is a best efforts offering, with no minimum amount of securities is required to be sold, and we may not raise the amount of capital we believe is required for our business plans, including our near-term business plans, nor will investors in this offering receive a refund in the event that we do not sell an amount of securities sufficient to pursue the business goals outlined in this prospectus.

The placement agent has agreed to use its reasonable best efforts to solicit offers to purchase the securities in this offering. The placement agent has no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to support our business goals and continued operations, including our near-term continued operations. Thus, we may not raise the amount of capital we believe is required for our operations in the short-term and may need to raise additional funds to complete such short-term operations. Such additional capital may not be available or available on terms acceptable to us, or at all.

There is no required minimumA significant number of securities that must be sold as a condition to completion of this offering,our shares are eligible for sale and we have not, nor will we, establish an escrow account in connection with this offering. Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, placement agent fees and proceeds to us are not presently determinable andtheir sale or potential sale may be substantially less than the maximum amounts set forth herein. Because there is no escrow account and no minimum offering amount, investors could be in a position where they have invested in us, but we are unable to fulfill our objectives due to a lack of interest in this offering. Further, because there is no escrow account in operation and no minimum investment amount, any proceeds from the sale of securities offered by us will be available for our immediate use, despite uncertainty about whether we would be able to use such funds to effectively implement our business plan. Investor funds will not be returned under any circumstances whether during or after the offering.

We have broad discretion in how we use the net proceeds of this offering, and we may not use these proceeds effectively or in ways with which you agree.

Our management will have broad discretion as to the application of the net proceeds of this offering and could use them for purposes other than those contemplated at the time of the offering. We intend to use the net proceeds, if any, from this offering to provide funding for our ongoing clinical and regulatory development of Lomecel-B™ for the

treatment of several disease states and indications, including HLHS and Alzheimer’s Disease, obtaining regulatory approvals, capital expenditures, working capital and other general corporate purposes. Our stockholders may not agree with the manner in which our management chooses to allocate and spend the net proceeds. Moreover, our management may use the net proceeds for corporate purposes that may not increasedepress the market price of our Class A common stock.

Sales of a significant number of shares of our Class A common stock or other securities. Seein the sectionpublic market could harm the market price of our Class A common stock. Most of our outstanding Class A common stock is available for resale in the public market, and the registration statement of which this prospectus titled “Useis a part registers for resale 145,020 shares of ProceedsClass A common stock issuable upon exercise of the December private placement warrants and December placement agent warrants. If a significant number of shares are sold in that offering or any future offerings, such sales would increase the supply of our Class A common stock and potentially cause a decrease in its market price. Some or all of our shares of Class A common stock may be offered from time to time in the open market pursuant to future effective registration statements and/or compliance with Rule 144, which sales could have a depressive effect on the market for our shares of Class A common stock. Subject to certain restrictions, a person who has held restricted shares for a period of six months may generally sell common stock into the market. The sale of a significant portion of such shares when such shares are eligible for public sale may cause the value of our Class A common stock to decline in value..”

Raising additional capital may cause future dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or current product candidates.

Until such time, if ever, as we can generate the cash we need from operations, we expect to finance our cash needs through a combination of private and public equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We do not currently have any committed external source of funds and in order to raise additional capital, we may offer and issue additional shares of our common stock or other securities convertible into or exchangeable for our common stock in the future. We are generally not restricted from issuing additional securities, including shares of Class A common stock, securities that are convertible into or exchangeable for, or that represent the right to receive, common stock or substantially similar securities. The issuance of securities in future offerings may cause further dilution to our stockholders, including investors in this offering. We cannot assure you that we will be able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the price per share paid by investors in this offering, and investors purchasing other securities in the future could have rights superior to existing stockholders. To the extent that we raise additional capital through the sale of Class A common stock or securities convertible into or exchangeable for Class A common stock, the ownership interest of our shareholders will be diluted, and the terms of these new securities may include liquidation or other preferences that materially adversely affect the rights of our shareholders. Debt financing, if available, would increase our fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third-parties,third-parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or current or future product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, scale back or discontinue the development and commercialization of one or more of our product candidates, delay our pursuit of potential licenses or acquisitions, or grant rights to develop and market current or future therapeutic candidates that we would otherwise prefer to develop and market ourselves.

In addition, we have a significant number of stock options, restricted stock units and warrants outstanding. To the extent that outstanding stock options or warrants have been or may be exercised or other shares issued, you may experience further dilution.

A substantial number of shares of our Class A common stock are being sold in this offering, which could cause the price of our Class A common stock to decline.

In this offering we are selling up to 2,461,538 shares of Class A common stock. In addition, we are also selling Class A common warrants to purchase up to 2,461,538shares of Class A common stock. In the aggregate, the maximum shares that could be issued in this offering represent approximately 200% of our outstanding Class A common stock and Class B common stock as of March28, 2024, after giving effect to this offering. This sale and any future sales of a substantial number of shares of our Class A common stock in the public market, or the perception that such sales may occur, could adversely affect the price of our Class A common stock on the Nasdaq Capital Market. We cannot predict the effect, if any, that market sales of those shares of Class A common stock or the availability of those shares of Class A common stock for sale will have on the market price of our Class A common stock.

We do not currently intend to pay dividends on our Class A common stock and, consequently, your ability to achieve a return on your investment will depend on appreciation of the value of our Class A common stock.

We have never declared or paid any cash dividends on our equity securities. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to any appreciation in the value of our Class A common stock, which is not certain.

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The price of our Class A common stock may be volatile or may decline regardless of our operating performance, and shareholdersstockholders may not be able to resell their shares at or above the price at which they purchase those shares.

Trading volume in shares of our Class A common stock on the Nasdaq Capital Market has been limited. You may not be able to sell your shares quickly or at the market price if trading in shares of our Class A common stock is not active. An active or liquid market in our Class A common stock may not develop or, if it does develop, it may not sustain. As a result of these and other factors, shareholdersstockholders may not be able to resell their shares of our Class A common stock at or above the price at which they purchase those shares in this offering.

Further, an inactive market may also impair our ability to raise capital by selling shares of our Class A common stock and may impair our ability to enter into strategic collaborations or acquire companies or products by using our shares of Class A common stock as consideration.

If you purchase our securities in this offering, you may incur immediate and substantial dilution in the book value of your shares of Class A common stock.

You may suffer immediate and substantial dilution in the net tangible book value of the Class A common stock you purchase in this offering. Based on the assumed public offering price of $3.25 per share and accompanying Class A common warrant, the last reported price of our Class A common stock on the Nasdaq Capital Market on March 28, 2024, we estimate our as adjusted net tangible book value per share of common stock after this offering will be $2.01. As a result, purchasers of securities in this offering will experience an immediate decrease of $1.24 per share in net tangible book value of our common stock. See the section of this prospectus titled “Dilution” for a more detailed description of these factors.

There is no public market for any pre-funded warrants or the Class A common warrants sold in this offering.

There is no established public trading market for the pre-funded warrants or Class A common warrants being sold in this offering. We will not list the pre-funded warrants or Class A common warrants on any securities exchange or nationally recognized trading system, including the Nasdaq Capital Market. Therefore, we do not expect a market to ever develop for the pre-funded warrants or Class A common warrants. Without an active market, the liquidity of the pre-funded warrants and Class A common warrants will be limited.

The pre-funded warrants and Class A common warrants are speculative in nature. Holders of the pre-funded warrants and the Class A common warrants offered hereby will have no rights as common stockholders with respect to the shares our Class A common stock underlying such warrants until such holders exercise their warrants and acquire our Class A common stock, except as otherwise provided in the pre-funded warrants and the Class A common warrants.

The pre-funded warrants and Class A common warrants do not confer any rights of Class A common stock ownership on their holders, such as voting rights or the right to receive dividends, but merely represent the right to acquire shares of Class A common stock at a fixed price. Commencing on the date of issuance, holders of pre-funded warrants and Class A common warrants may exercise their right to acquire the underlying Class A common stock and pay the respective stated warrant exercise price per share. Following this offering, the market value of the Class A common warrants is uncertain and there can be no assurance that the market value of the Class A common warrants, if any, will equal or exceed their public offering prices. There can be no assurance that the market price of the shares of Class A common stock will ever equal or exceed the exercise price of the Class A common warrants, and consequently, whether it will ever be profitable for holders of Class A common warrants to exercise the Class A common warrants.

Until holders of pre-funded warrants and Class A common warrants acquire shares of our Class A common stock upon exercise thereof, holders of such pre-funded warrants and Class A common warrants will have no rights with respect to shares of our Class A common stock, except as provided in the pre-funded warrants and Class A common warrants, respectively. Upon exercise of the pre-funded warrants and Class A common warrants, such holders will be entitled to the rights of a Class A common stockholder only as to matters for which the record date occurs after the exercise date.

Resales of our shares of Class A common stock in the public market by our stockholders as a result of this offering may cause the market price of our shares of Class A common stock to fall.

We are registering 2,461,538shares of Class A common stock, as well as 5,095,384shares of Class A common stock, in the aggregate, issuable upon the exercise of the pre-funded warrants and the Class A common warrants offered under this prospectus, as well as the Placement Agent Warrants. Sales of substantial amounts of our shares of Class A common stock in the public market, or the perception that such sales might occur, could adversely affect the market price of our shares of Class A common stock. The issuance of new shares of Class A common stock could result in resales of our shares of Class A common stock by our current shareholders concerned about the potential ownership dilution of their holdings. Furthermore, in the future, we may issue additional shares of common stock or other equity or debt securities exercisable or convertible into shares of common stock. Any such issuance could result in substantial dilution to our existing shareholders and could cause our stock price to decline.

Risks Related to Our Class A Common Stock and the Securities Market

The price of our Class A common stock has been, and may continue to be, volatile, which could result in substantial or total losses for investors.

The trading price of our Class A common stock has been, and may continue to be, highly volatile and subject to wide fluctuations in response to various factors, some of which we cannot control. The stock market in general, and pharmaceutical and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

Broad market and industry factors may negatively affect the market price of our Class A common stock, regardless of our actual operating performance. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this prospectus, these factors include:

• the timing and results, or perception of the results, of preclinical studies and clinical trials of our product candidates or those of our competitors;

•

 the success of competitive products or announcements by potential competitors of their product development efforts;

•regulatory actions with respect to our or our competitors’ product candidates or approved products;

•actual or anticipated changes in our growth rate relative to our competitors;

•regulatory or legal developments in the U.S. and other countries;

•developments or disputes concerning patent applications, issued patents or other proprietary rights;

•the recruitment or departure of key personnel;

•announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, or capital commitments;

•actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

•fluctuations in the valuation of companies perceived by investors to be comparable to us;

•market conditions in the pharmaceutical and biotechnology sector;

•changes in the structure of healthcare payment systems;

•Class A common stock price and volume fluctuations attributable to inconsistent trading volume levels of our Class A common stock;

•announcement or expectation of additional financing efforts;

•sales of our Class A common stock by us, our insiders or our other stockholders;

•expiration of market stand-off or lock-up agreements; and

•general economic, industry and market conditions.

The realization of any of the above risks or any of a broad range of other risks, including those described in this “Risk Factors” section, could have a dramatic and adverse impact on the market price of our Class A common stock. Additionally, in the past, securities class action litigation has often been instituted against companies following periods of volatility in the market price of a company’s securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources.

There may not be sufficient liquidity in the market for our securities in order for investors to sell their shares.

We are a small company that is relatively unknown to stock analysts, stockbrokers, institutional investors and others in the investment community that generate or influence sales volume, and even if we came to the attention of such persons, they tend to be risk-averserisk-averse and may be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable. There may be periods of several days or more when trading activity in our shares is minimal as compared to a mature issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price. It is possible that a broader or more active public trading market for our Class A common stock will not develop or be sustained, or that trading levels will not continue. These factors may materially adversely affect the market price of our Class A common stock, regardless of our performance.

We will need to raise substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, scale back or discontinue some of our therapeutic candidate development programs or commercialization efforts.

The development of pharmaceutical drugs is capital intensive. We are currently advancing Lomecel-BLomecel-B^TM into clinical development. Our current cash resources are insufficient to fund our planned operations or development plans beyond the beginning of the second quarter of 2024. We will require additional funds to advance further. If we are capital constrained, we may not be able to meet our obligations. If we are unable to meet our obligations, or we experience a disruption in our cash flows, it could limit or halt our ability to continue to develop our current product candidate or even to continue operations, either of which occurrence would have a material adverse effect on us.

We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we continue the research and development of, advance the preclinical and clinical activities of, and seek marketing approval for, our current product candidate. In addition, if we obtain marketing approval for any of our current or future product candidates, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution. We may also need to raise additional funds sooner if we choose to pursue additional indications and/or geographies for our current product candidate or otherwise expand more rapidly than we presently anticipate. Furthermore, we expect to continue to incur significant costs associated with operating as a public company. If we are unable to raise capital when needed, we could be forced to delay, scale back or discontinue the development and commercialization of one or more of our therapeutic candidates, delay our pursuit of potential licenses or acquisitions, or significantly reduce our operations.

We expect that the net proceeds from recent offerings, together with our existing cash, will be sufficient to fund our operations only for various amounts of time in 2024 depending on the amount of net proceeds we obtain. Our future capital requirements will depend on and could increase significantly as a result of many factors, including:

• the scope, progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our current or future therapeutic candidates;

• the potential additional expenses attributable to adjusting our development plans (including any supply-related matters) to the COVID-19 pandemic;

• the scope, prioritization and number of our research and development programs;

• the costs, timing and outcome of regulatory review of our current or future therapeutic candidates;

• our ability to establish and maintain collaborations on favorable terms, if at all;

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