Nature of Business, Basis of Presentation, and Liquidity

12 Months Ended

Dec. 31, 2023

Nature of Business, Basis of Presentation, and Liquidity [Abstract]

Nature of Business, Basis of Presentation, and Liquidity

1. Nature of Business, Basis of Presentation, and Liquidity

Nature of business:

Longeveron LLC was formed as a Delaware limited liability company on October 9, 2014 and authorized to transact business in Florida on December 15, 2014. On February 12, 2021, Longeveron LLC converted its corporate form (the “Corporate Conversion”) from a Delaware limited liability company (Longeveron, LLC) to a Delaware corporation, Longeveron Inc. (the “Company,” “Registrant,” “Longeveron,”, “we,” “us,” or “our”). The Company is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company operates out of its leased facilities in Miami, Florida.

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on licenses, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive pre-clinical studies and clinical trials and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting capabilities.

The Company’s product candidates are currently in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid technological change and substantial competition from, among others, existing pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, partners and consultants.

Going Concern and Liquidity:

Since inception, the Company has primarily been engaged in organizational activities, including raising capital, and research and development activities. The Company does not yet have a product that has been approved by the U.S. Food and Drug Administration (“FDA”), and has only generated revenues from grants, the Bahamas Registry Trials and contract manufacturing. The Company has not yet achieved profitable operations or generated positive cash flows from operations. The Company intends to continue its efforts to raise additional equity financing, develop its intellectual property, and secure regulatory approvals to commercialize its products. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. Further, the Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital, its research and commercialization efforts, regulatory approval, and, ultimately, the market acceptance of the Company’s products. These financial statements do not include adjustments that might result from the outcome of these uncertainties.

The Company has incurred recurring losses from operations since its inception, including a net loss of $21.4 million and $18.8 million for the years ended December 31, 2023 and 2022, respectively. In addition, as of December 31, 2023, the Company had an accumulated deficit of $85.0 million. The Company expects to continue to generate operating losses for the foreseeable future.

As of December 31, 2023, the Company had cash and cash equivalents of $4.9 million and marketable securities of $0.4 million. The Company has prepared a cash flow forecast which indicates that it does not have sufficient cash to meet its minimum expenditure commitments for one year from the date these financial statements are available to be issued and therefore needs to raise additional funds to continue as a going concern. As a result, there is substantial doubt about the Company’s ability to continue as a going concern. To address the future funding requirements, in addition to planning future sales of equity securities, management has undertaken the following initiatives: 

● On October 11, 2023 the Company entered into a securities purchase agreement with an institutional and accredited investor (the “Purchaser”) relating to the registered direct offering and sale of an aggregate of 2,365,000 shares of the Company’s Class A common stock, par value $0.001 per share and pre-funded warrants to purchase up to 59,243 shares of Class A common stock at an exercise price of $0.001 per share, at a purchase price of $1.65 per share and $1.649 per pre-funded Warrant (the “October 2023 Registered Direct Offering”), which Offering closed and was funded October 13, 2023.

In a concurrent private placement, the Company also sold to the Purchaser unregistered Series A warrants to purchase up to an aggregate of 2,424,243 shares of its Class A common stock and unregistered Series B warrants to purchase up to an aggregate of 2,424,243 shares of its Class A common stock (the “Warrants”)( the “October 2023 Private Placement” and collectively, with the October 2023 Registered Direct Offering, the “October 2023 Offering”). The Series A Warrants have an exercise price of $1.65 per share and have a term of five and one-half years from the date of issuance. The Series B Warrants have an exercise price of $1.65 per share and have a term of eighteen months from the date of issuance. The Series A and B warrants became exercisable upon stockholder approval on December 26, 2023, and each Warrant is exercisable for one share of Class A common stock. The net proceeds to the Company from the October 2023 Offering was approximately $3.4 million, after deducting placement agent fees and other offering expenses paid by the Company totaling approximately $0.6 million.

● On December 20, 2023 the Company entered into a securities purchase agreement with Purchaser relating to the registered direct offering and sale of an aggregate of 1,355,301 shares of the Company’s Class A common stock, par value $0.001 per share, at a purchase price of $1.745 per share of common stock (the “December 2023 Registered Direct Offering”), which Offering closed and was funded on December 22, 2023.

In private placement on December 22, 2023, concurrent with the December 2023 Registered Direct Offering, the Company also sold to the Purchaser unregistered long-term warrants to purchase up to an aggregate of 1,355,301 shares of its Class A common stock (the “December 2023 Private Placement”, and together with the December 2023 Registered Direct Offering, the “December 2023 Offering”) . The unregistered December 2023 Private Placement warrants have an exercise price of $1.62 per share, became immediately exercisable upon issuance, and expire on June 20, 2029. The purchaser may not exercise any portion of the December 2023 Private Placement warrants to the extent the Purchaser would own more than 4.99% of the Company’s outstanding common stock immediately after the exercise. The Purchaser may decrease, upon at least 61 days’ prior notice to the Company, increase this percentage with respect to the December 2023 Private Placement warrants. In no event shall such beneficial ownership limitation exceed 9.99%. and have a term of five and one-half years from the date of issuance. The net proceeds to the Company from the 2023 December 2023 Offering was approximately $2.0 million, after deducting placement agent fees and other offering expenses paid by the Company totaling approximately $0.3 million. 

● the Company will attempt to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners;

● the Company plans to pursue potential partnerships for pipeline programs, however, there can be no assurances that it can consummate such transactions;

● the Company will continue to support its Bahamas Registry to generate revenue; and

● since 2016 our clinical programs have received over $16.0 million in competitive extramural grant awards ($11.5 million which has been directly awarded to us and which are recognized as revenue when the performance obligations are met) from the National Institutes of Health (“NIH”), Alzheimer’s Association, and Maryland Stem Cell Research Fund (“MSCRF”), and the Company plans to submit additional contract and grant applications for further support of its programs with various funding agencies.

The Company’s financial statements do not include any adjustments to the assets carrying amount, to the expenses presented and to the reclassification of the balance sheets items that could be necessary should the Company be unable to continue its operations.