UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
For the quarterly period ended
OR
For the transition period from to .
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant
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As of May 10, 2024, the registrant had
LONGEVERON INC.
TABLE OF CONTENTS
i
PART I. FINANCIAL INFORMATION
Item 1. Condensed Financial Statements.
Longeveron Inc.
Condensed Balance Sheets
(In thousands, except share and per share data)
| March 31, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Marketable securities | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Accounts and grants receivable | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Intangible assets, net | ||||||||
| Operating lease asset | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Current portion of lease liability | ||||||||
| Deferred revenue | ||||||||
| Total current liabilities | ||||||||
| Long-term liabilities: | ||||||||
| Lease liability | ||||||||
| Other liabilities | ||||||||
| Total long-term liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $ | ||||||||
| Class A common stock, $ | ||||||||
| Class B common stock, $ | ||||||||
| Additional paid-in capital | ||||||||
| Stock subscription receivable | ( | ) | ||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Accumulated other comprehensive gain | ||||||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See accompanying notes to unaudited condensed financial statements.
1
Longeveron Inc.
Condensed Statements of Operations
(In thousands, except per share data)
(Unaudited)
| Three months ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenues | ||||||||
| Clinical trial revenue | $ | $ | ||||||
| Contract manufacturing revenue | ||||||||
| Grant revenue | ||||||||
| Total revenues | ||||||||
| Cost of revenues | ||||||||
| Gross profit | ||||||||
| Operating expenses | ||||||||
| General and administrative | ||||||||
| Research and development | ||||||||
| Total operating expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Other income and (expenses) | ||||||||
| Other income, net | ||||||||
| Total other income, net | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| $ | ( | ) | $ | ( | ) | |||
See accompanying notes to unaudited condensed financial statements.
2
Longeveron Inc.
Condensed Statements of Comprehensive Loss
(In thousands)
(Unaudited)
| Three months ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Other comprehensive gains: | ||||||||
| Net unrealized gains on available-for-sale securities | ||||||||
| Total comprehensive loss | $ | ( | ) | $ | ( | ) | ||
See notes to unaudited condensed financial statements.
3
Longeveron Inc.
Condensed Statements of Stockholders’ Equity
(In thousands, except share amounts)
(Unaudited)
| Class A Common Stock | Class B Common Stock | Subscription | Additional Paid-In | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | ||||||||||||||||||||||||||||||
| Number | Amount | Number | Amount | Receivable | Capital | Deficit | Gain | Equity | ||||||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | $ | |||||||||||||||||||||||||
| Conversion of Class B common stock for Class A common stock | ( | ) | ||||||||||||||||||||||||||||||||||
| Class A common stock, issued for RSUs vested | - | |||||||||||||||||||||||||||||||||||
| Class A common stock, held for taxes on RSUs vested | ( | ) | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||
| Class A common stock, issued for PSUs vested | - | |||||||||||||||||||||||||||||||||||
| Class A common stock, held for taxes on PSUs vested | ( | ) | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||
| Collection of stock subscription receivable | - | - | ||||||||||||||||||||||||||||||||||
| Equity-based compensation | - | - | ||||||||||||||||||||||||||||||||||
| Unrealized gain attributable to change in market value of available for sale investments | - | - | ||||||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Balance at March 31, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | $ | |||||||||||||||||||||||||||
See notes to unaudited condensed financial statements.
4
Longeveron Inc.
Condensed Statements of Stockholders’ Equity
(In thousands, except share amounts)
(Unaudited)
| Class A Common Stock | Class B Common Stock | Subscription | Additional Paid-In | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | ||||||||||||||||||||||||||||||
| Number | Amount | Number | Amount | Receivable | Capital | Deficit | Loss | Equity | ||||||||||||||||||||||||||||
| Balance at December 31, 2022 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||
| Conversion of Class B common stock into Class A common stock | ( | ) | ||||||||||||||||||||||||||||||||||
| Class A common stock, issued for RSUs vested | - | |||||||||||||||||||||||||||||||||||
| Class A common stock, held for taxes on RSUs vested | ( | ) | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||
| Equity-based compensation | - | - | ||||||||||||||||||||||||||||||||||
| Unrealized gain attributable to change in market value of available for sale investments | - | - | ||||||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Balance at March 31, 2023 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||
See notes to unaudited condensed financial statements.
5
Longeveron Inc.
Condensed Statements of Cash Flows
(In thousands)
(Unaudited)
| Three months ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Interest earned on marketable securities | ||||||||
| Equity-based compensation | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts and grants receivable | ( | ) | ||||||
| Prepaid expenses and other current assets | ( | ) | ( | ) | ||||
| Other assets | ( | ) | ||||||
| Accounts payable | ( | ) | ||||||
| Deferred revenue | ||||||||
| Accrued expenses | ( | ) | ||||||
| Operating lease asset and lease liability | ( | ) | ( | ) | ||||
| Other liabilities | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Proceeds from the sale of marketable securities | ||||||||
| Acquisition of property and equipment | ( | ) | ( | ) | ||||
| Acquisition of intangible assets | ( | ) | ( | ) | ||||
| Net cash provided by investing activities | ||||||||
| Cash flows from financing activities | ||||||||
| Payments for taxes on RSUs vested | ( | ) | ( | ) | ||||
| Proceeds from stock subscription receivable | ||||||||
| Net cash provided by (used in) financing activities | ( | ) | ||||||
| Change in cash and cash equivalents | ( | ) | ( | ) | ||||
| Cash and cash equivalents at beginning of the period | ||||||||
| Cash and cash equivalents at end of the period | $ | $ | ||||||
| Supplement Disclosure of Non-cash Investing and Financing Activities: | ||||||||
| Vesting of RSUs and PSUs into Class A common stock | $ | ( | ) | $ | ( | ) | ||
See accompanying notes to unaudited condensed financial statements.
6
Longeveron Inc.
Notes to Unaudited Condensed Financial Statements
Three Month Periods Ended March 31, 2024 and 2023
1. Nature of Business, Basis of Presentation, and Liquidity
Nature of business:
Longeveron was formed as a Delaware limited liability company on October 9, 2014, and was 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,” “Longeveron” or “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’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.
The accompanying interim condensed balance sheet as of March 31, 2024, and the condensed statements of operations, statements of comprehensive loss, stockholders’ equity, and cash flows for the three months ended March 31, 2024 and 2023, are unaudited. The unaudited condensed financial statements have been prepared according to the rules and regulations of the Securities and Exchange Commission (“SEC”) and, therefore, certain information and disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been omitted. In the opinion of management, the accompanying unaudited condensed financial statements for the periods presented reflect all adjustments which are normal and recurring, and necessary to fairly state the financial position, results of operations, and cash flows of the Company. These unaudited condensed financial statements and notes should be read in conjunction with the audited financial statements and notes thereto in the Company’s 2023 Annual Report on Form 10-K filed with the SEC on February 27, 2024.
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, clinical 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 funds via 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 approved products, if any. These condensed 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 $
7
As of March 31, 2024, the Company had cash and cash equivalents of
$
| ● | the Company may seek additional capital in the private and/or public equity markets, to continue its operations, respond to competitive pressures, develop new products and services, and to support new strategic partnerships. The Company is evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that the Company can consummate such a transaction or consummate a transaction at favorable pricing; |
| ● | 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 $ |
The Company’s condensed financial statements do not include any adjustments to the assets’ carrying amount, to the expenses presented and to the reclassification of the condensed balance sheets items that could be necessary should the Company be unable to continue its operations.
2. Summary of Significant Accounting Policies
Basis of presentation:
The condensed financial statements of the Company were prepared in accordance with U.S. GAAP.
Certain reclassifications have been made to prior year condensed financial statements to conform to classifications used in the current year. These reclassifications had no impact on net loss, stockholders’ equity or cash flows as previously reported.
Reverse Stock Split:
On March 26, 2024, the Company effected a reverse stock split of the outstanding shares of its Class A common stock and Class B common stock on a one-for-10 (1:10) basis (the “Reverse Stock Split”). The Reverse Stock Split became effective at 11:59 p.m. Eastern Time on March 26, 2024 via a certificate of amendment to the Company’s Certificate of Incorporation filed with the Secretary of State of the State of Delaware. At the effective time of the Reverse Stock Split, every 10 shares of the Company’s Class A common stock and Class B common stock, whether issued and outstanding or held by the Company as treasury stock, were automatically combined and converted (without any further act) into one fully paid and nonassessable share of Class A common stock or Class B common stock, respectively, subject to rounding up of fractional shares to the nearest whole number of shares resulting from the Reverse Stock Split without any change in the par value per share. All share, per share, option, warrant, equity award, and other derivative security numbers and exercise prices appearing in this Quarterly Report on Form 10-Q and the accompanying condensed financial statements have been adjusted to give effect to the Reverse Stock Split for all prior periods presented. However, the Company’s annual, other periodic, and current reports, and all other information and documents incorporated by reference into this Quarterly Report on Form 10-Q that were filed prior to March 19, 2024, do not give effect to the Reverse Stock Split.
Use of estimates:
The presentation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
8
Accounting Standard Updates:
A variety of proposed or otherwise potential accounting standards are currently under consideration by standard-setting organizations and certain regulatory agencies. Because of the tentative and preliminary nature of such proposed standards, management has not yet determined the effect, if any, that the implementation of such proposed standards would have on the Company’s condensed financial statements.
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09, “Improvements to Income Tax Disclosures”. The amendments in this ASU change disclosure requirements for various items, including effective tax rate reconciliations and cash taxes paid. This ASU is effective for public companies for the financial reporting periods beginning on January 1, 2025, with early adoption permitted. We have not adopted ASU 2023-09 for our financial reporting period ending December 31, 2023, and will continue to evaluate early adoption for our financial reporting period ending December 31, 2024.
Cash and cash equivalents:
The Company considers cash to consist of cash on hand and temporary investments having an original maturity of 90 days or less that are readily convertible into cash.
Marketable securities:
Marketable securities at March 31, 2024 and December 31, 2023 consisted
of marketable fixed income securities, primarily corporate bonds which are categorized as available for sale securities and are thus marked
to market and stated at fair value in accordance with ASC 820 Fair Value Measurement. These investments are considered
Level 1 and Level 2 investments within the ASC 820 fair value hierarchy. The fair value of Level 1 investments, including cash equivalents,
money funds and U.S. government securities, are substantially based on quoted market prices in active markets. The fair value of corporate
bonds is determined using standard market valuation methodologies, including discounted cash flows, matrix pricing and/or other similar
techniques. The inputs to these valuation techniques include but are not limited to market interest rates, credit rating of the issuer
or counterparty, industry sector of the issuer, coupon rate, call provisions, maturity, estimated duration and assumptions regarding liquidity
and estimated future cash flows. In addition to bond characteristics, the valuation methodologies incorporate market data, such as
actual trades completed, bids and actual dealer quotes, where such information is available. Accordingly, the estimated fair values are
based on available market information and judgments about financial instruments categorized within Level 1 and Level 2 of the fair value
hierarchy. Interest and dividends are recorded when earned. Realized gains and losses on investments are determined by specific
identification and are recognized as incurred in the condensed statement of operations. Changes in net unrealized gains and losses
are reported in other comprehensive loss and represent the change in the fair value of investment holdings during the reporting period. Changes
in net unrealized losses were $
Accounts and grants receivable:
Accounts and grants receivable include amounts due from customers, granting institutions and others. The amounts as of March 31, 2024, and December 31, 2023 are certain to be collected, and no amount has been recognized for doubtful accounts. In addition, for the clinical trial revenue, most participants pay in advance of treatment. Advanced grant funds and prepayments for the clinical trial revenue are recorded to deferred revenue. Advance contract manufacturing payments are recorded to deferred revenue.
| March 31, 2024 | December 31, 2023 | |||||||
| National Institutes of Health – Grant | $ | $ | ||||||
| Accounts receivable from customers | ||||||||
| Total | $ | $ | ||||||
9
Deferred offering costs:
The Company recorded certain legal, professional and other third-party fees that were directly associated with in-process equity financings as deferred offering costs until the applicable equity financing was consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of proceeds generated as a result of the offering.
Property and equipment:
Property and equipment, including improvements that extend the useful lives of related assets, are recorded at cost, while maintenance and repairs are charged to operations as incurred. Depreciation is calculated using the straight-line method based on the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the original term of the lease. Depreciation expense is recorded in the research and development line of the condensed statements of operations as the assets are primarily related to the Company’s clinical programs.
Intangible assets:
Intangible assets include payments on license agreements with the Company’s co-founder and Chief Scientific Officer (“CSO”) and the University of Miami (“UM”) (see Note 9) and legal costs incurred related to patents and trademarks. License agreements have been recorded at the value of cash consideration, common stock and membership units transferred to the respective parties when acquired.
Payments for license agreements are amortized using the straight-line
method over the estimated term of the agreements, which range from
Impairment of Long-Lived Assets:
The Company evaluates long-lived assets for impairment, including property and equipment and intangible assets, when events or changes in circumstances indicate that the carrying value of such assets may not be recoverable. Upon the occurrence of a triggering event, the asset is reviewed to assess whether the estimated undiscounted cash flows expected from the use of the asset plus the residual value from the ultimate disposal exceeds the carrying value of the asset. If the carrying value exceeds the estimated recoverable amounts, the asset is written down to the estimated fair value. Any resulting impairment loss is reflected in the condensed statements of operations. Upon evaluation, management determined that there was no impairment of long-lived assets during the three months ended March 31, 2024 and 2023.
Deferred revenue:
The unearned portion of advanced grant funds and prepayments for clinical
trial and contract manufacturing revenues, which will be recognized as revenue when the Company meets the respective performance obligations,
has been presented as deferred revenue in the accompanying condensed balance sheets. For both of the three months ended March 31, 2024
and 2023, the Company recognized $
Revenue recognition:
The Company recognizes revenue when performance obligations related to respective revenue streams are met. For grant revenue, the Company considers the performance obligation met when the grant related expenses are incurred or supplies and materials are received. The Company is paid in tranches pursuant to terms of the related grant agreements, and then applies payments based on regular expense reimbursement submissions to grantors. There are no remaining performance obligations or variable consideration once grant expense reporting to the grantor is complete. For clinical trial revenue, the Company considers the performance obligation met when the participant has received the treatment. The Company usually receives prepayment for these services or receives payment at the time the treatment is provided, and there are no remaining performance obligations or variable consideration once the participant receives the treatment. For contract manufacturing revenue, the Company considers the performance obligation met when the contractual obligation and/or statement of work has been satisfied. Payment terms may vary depending on specific contract terms. There are no significant judgments affecting the determination of the amount and timing of revenue recognition.
10
| Three months ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| NIH - grant | $ | $ | ||||||
| Clinical trial revenue | ||||||||
| Contract manufacturing | ||||||||
| Total | $ | $ | ||||||
The Company records cost of revenues based on expenses directly related to revenue. For grants, the Company records allocated expenses for research and development costs to a grant as a cost of revenues. For the clinical trial revenue, directly related expenses for that program are expensed as incurred. These expenses are similar to those described under “Research and development expense” below. For the contract manufacturing, the Company records costs incurred under the contract as cost of revenues.
Research and development expense:
Research and development costs are charged to expense when incurred in accordance with ASC 730 Research and Development. ASC 730 addresses the proper accounting and reporting for research and development costs. It identifies: 1) those activities that should be identified as research and development; 2) the elements of costs that should be identified with research and development activities, and the accounting for these costs; and 3) the financial statement disclosures related to them. Research and development costs include costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, property and equipment depreciation and allocation of various corporate costs. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered.
Concentrations of credit risk:
Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents, marketable securities and accounts and grants receivable. Cash and cash equivalents are held in U.S. financial institutions. At times, the Company may maintain balances in excess of the federally insured amounts.
Income taxes:
The Company’s tax provision consists of taxes currently payable
or receivable, plus any change during the period in deferred tax assets and liabilities. The Company uses the asset and liability method
of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis.
Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those
temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates
is recognized in income in the period that includes the enactment date. In addition, a valuation allowance is established to reduce any
deferred tax asset for which it is determined that it is more likely than not that some portion of the deferred tax asset will not be
realized. The Company’s tax provision was $
The Company recognizes the tax benefits from uncertain tax positions that the Company has taken or expects to take on a tax return. In the unlikely event an uncertain tax position exists in which the Company could incur income taxes, the Company would evaluate whether there is a probability that the uncertain tax position taken would be sustained upon examination by a taxing authority. Reserves for uncertain tax positions would then be recorded if the Company determined it is probable that either a position would not be sustained upon examination, or a payment would have to be made to a taxing authority and the amount was reasonably estimable. As of March 31, 2024 and December 31, 2023, the Company does not believe it has any uncertain tax positions that would result in the Company having a liability to a taxing authority. It is the Company’s policy to expense any interest and penalties associated with its tax obligations when they are probable and estimable.
11
Equity-based compensation:
The Company accounts for equity-based compensation expense by the measurement and recognition of compensation expense for stock-based awards based on estimated fair values on the date of grant. The fair value of the stock options is estimated at the date of the grant using the Black-Scholes option-pricing model.
The Black-Scholes option-pricing model requires the input of highly subjective assumptions, the most significant of which are the expected share price volatility, the expected life of the stock option award, the risk-free rate of return, and dividends during the expected term. Because the option-pricing model is sensitive to changes in the input assumptions, different determinations of the required inputs may result in different fair value estimates of the stock options.
Neither the Company’s stock options nor its restricted stock
units (“RSUs”) trade on an active market. Volatility is a measure of the amount by which a financial variable, such as a stock
price, has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Given the Company’s
limited historical data, the Company utilizes the average historical volatility of similar publicly traded companies that are in the same
industry. The risk-free interest rate is the average U.S. treasury rate (having a term that most closely approximates the expected life
of the option) for the period in which the stock option was granted. The expected life is the period of time that the stock options granted
are expected to remain outstanding. Stock options granted have a maximum term of
3. Marketable securities
| Fair Value at March 31, 2024 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Corporate bonds | $ | $ | $ | $ | ||||||||||||
| Money market funds(1) | ||||||||||||||||
| Accrued income | ||||||||||||||||
| Total marketable securities | $ | $ | $ | $ | ||||||||||||
| (1) |
| Fair Value at December 31, 2023 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Corporate bonds | $ | $ | $ | $ | ||||||||||||
| Money market funds(1) | ||||||||||||||||
| Accrued income | ||||||||||||||||
| Total marketable securities | $ | $ | $ | $ | ||||||||||||
| (1) | Money market funds are included in cash and cash equivalents in the condensed balance sheet. |
As of March 31, 2024 and December 31, 2023, the Company reported accrued
interest receivable related to marketable securities of less than $
12
4. Property and equipment, net
| Useful Lives | March 31, 2024 | December 31, 2023 | ||||||||
| Leasehold improvements | $ | $ | ||||||||
| Furniture/Lab equipment | ||||||||||
| Computer equipment | ||||||||||
| Software/Website | ||||||||||
| Total property and equipment | ||||||||||
| Less accumulated depreciation and amortization | ||||||||||
| Property and equipment, net | $ | $ | ||||||||
Depreciation and amortization expense amounted to approximately $
5. Intangible assets, net
| Useful Lives | Cost | Accumulated Amortization | Total | |||||||||||
| License agreements | $ | $ | ( | ) | $ | |||||||||
Patent costs | ||||||||||||||
| Trademark costs | ||||||||||||||
| Total | $ | $ | ( | ) | $ | |||||||||
Major components of intangible assets as of December 31, 2023, are as follows:
| Useful Lives | Cost | Accumulated Amortization | Total | |||||||||||
| License agreements | $ | $ | ( | ) | $ | |||||||||
| Patent costs | ||||||||||||||
| Trademark costs | ||||||||||||||
| Total | $ | $ | ( | ) | $ | |||||||||
Amortization expense related to intangible assets
amounted to approximately $
| Year Ending December 31, | Amount | |||
| 2024 (remaining nine months) | $ | |||
| 2025 | ||||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| Thereafter | ||||
| Total | $ | |||
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6. Leases
The Company records a right-of-use operating lease asset and a lease
liability related to its operating leases (there are no finance leases). The Company’s corporate office lease expires in March 2027.
As of March 31, 2024, the operating lease asset and lease liability were approximately $
| Year Ending December 31, | Amount | |||
| 2024 (remaining nine months) | $ | |||
| 2025 | ||||
| 2026 | ||||
| 2027 | ||||
| Total | ||||
| Less: Interest | ||||
| Present value of operating lease liability | $ | |||
During each of the three months ended March 31, 2024 and 2023, the
Company incurred approximately $
7. Stockholders’ Equity
Class A Common Stock
Restricted Stock Units (“RSUs”) are taxable upon vesting based on the market value on the date of vesting. The Company is required to make mandatory tax withholding for the payment and satisfaction of income tax, social security tax, payroll tax, or payment on account of other tax related to withholding obligations that arise by reason of vesting of an RSU. The taxable income is calculated by multiplying the number of vested RSUs for each individual by the closing share price as of the vesting date and a tax liability is calculated based on each individual’s tax bracket. The shares withheld are available for reissuance pursuant to the Company’s 2021 Incentive Award Plan.
During the three months ended March 31, 2024, no stock options were exercised for Class A common stock shares.
Class B Common Stock
In connection with the Corporate Conversion,
Holders of Class A common stock generally have rights identical to
holders of Class B common stock, except that holders of Class A common stock are entitled to
During the three months ended March 31, 2024, stockholders exchanged
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Warrants
As part of the Company’s initial public offering (“IPO”),
the underwriter received warrants to purchase
As part of the 2021 PIPE Offering, the Company issued
On August 16, 2023, the Company announced its Stock Rights Offering,
which triggered the downward pricing mechanism on the Purchaser Warrants, at which time these warrants were adjusted downward to an exercise
price of $
As part of the October 2023 Offering, the Company issued an aggregate
of
As part of the December 2023 Offering, the Company sold unregistered
long-term warrants to purchase an aggregate of
8. Equity Incentive Plan
As part of the Company’s IPO, the Company adopted and approved the 2021 Incentive Award Plan (“2021 Incentive Plan”). Under the 2021 Incentive Plan, the Company may grant cash and equity incentive awards to eligible service providers in order to attract, motivate and retain the talent for which the Company competes.
RSUs
As of March 31, 2024, and December 31, 2023, the Company had
| Number of RSUs | ||||
| Outstanding (unvested) at December 31, 2023 | ||||
| RSU granted | ||||
| RSUs vested | ( | ) | ||
| RSU expired/forfeited | ( | ) | ||
| Outstanding (unvested) at March 31, 2024 | ||||
15
Stock Options
Stock options may be granted under the 2021 Incentive Plan. The exercise
price of stock options is equal to the fair market value of the Company’s Class A common stock as of the grant date. Stock options
historically granted have generally become exercisable over
As of March 31, 2024, there have been no stock options granted during
2024. The fair value of the options issued during 2023 were estimated using the Black-Scholes option-pricing model and had the following
assumptions: a dividend yield of
As of March 31, 2024 and December 31, 2023, the Company has recorded
issued and outstanding options to purchase a total of
| Number of Stock Options | ||||
| Stock options vested (based on ratable vesting) | ||||
| Stock options unvested | ||||
| Total stock options outstanding at March 31, 2024 | ||||
| Number of Stock Options | ||||
| Stock options vested (based on ratable vesting) | ||||
| Stock options unvested | ||||
| Total stock options outstanding at December 31, 2023 | ||||
| Number of Stock Options | Weighted Average Exercise Price | |||||||
| Outstanding at December 31, 2023 | $ | |||||||
| Options granted | ||||||||
| Options exercised | ||||||||
| Options expired/forfeited | ( | ) | ( | ) | ||||
| Outstanding at March 31, 2024 | $ | |||||||
For the three months ended March 31, 2024 and 2023, the equity-based
compensation expense amounted to approximately $
As of March 31, 2024, the remaining unrecognized equity-based compensation
(which includes RSUs and stock options) of approximately $
16
9. Commitments and Contingencies
Master Services Agreements:
As of March 31, 2024, the Company had two active master services agreements
with third parties to conduct its clinical trials and manage clinical research programs and clinical development services. The Company
expects these agreements or amended current agreements to have total expenditures of approximately $
As of December 31, 2023, the
Company had three active master services agreements with third parties to conduct its clinical trials and manage clinical research programs
and clinical development services on behalf of the Company. The Company expects these agreements or amended current agreements to have
total expenditures of approximately $
Consulting Services Agreement:
On November 20, 2014, the Company entered into a ten-year consulting
services agreement with Dr. Joshua Hare, its CSO. Under the agreement, the Company has agreed to pay the CSO $
Technology Services Agreement:
On March 27, 2015, the Company entered into a technology services agreement
with Optimal Networks, Inc. (a related company owned by Dr. Joshua Hare’s brother-in-law) for use of information technology services.
The technology services agreement was terminated as of April 14, 2023. As of March 31, 2024 and December 31, 2023, the Company owed $
Exclusive Licensing Agreements:
UM Agreement
On November 20, 2014, the Company entered into an Exclusive License
Agreement with UM (the “UM License”) for the use of certain Aging-related Frailty Mesenchymal Stem Cell (“MSC”)
technology rights developed by our CSO at UM. The UM License is a worldwide, exclusive license, with right to sublicense, with respect
to any and all know-how specifically related to the development of the culture-expanded MSCs for Aging-related Frailty used at the Human-induced
pluripotent stem cell-derived MSCs (“IMSCs”), all standard operating procedures used to create the IMSCs, and all data supporting
isolation, culture, expansion, processing, cryopreservation and management of the IMSCs. The Company is required to pay UM (i) a license
issue fee of $
17
The milestone payment amendments shifted the triggering payments to
three payments of $
The Company has the right to terminate the UM License upon 60 days’
prior written notice, and either party has the right to terminate upon a breach of the UM License. To date, the Company has made payments
totaling $
CD271
On December 22, 2016, the Company entered into an exclusive license
agreement with an affiliated entity of Dr. Joshua Hare, JMH MD Holdings, LLC (“JMHMD”), for the use of CD271 cellular therapy
technology. The Company recorded the value of the cash consideration and membership units issued to obtain this license agreement as an
intangible asset. The Company is required to pay as a royalty
Other Royalty
Under the grant award agreement with the Alzheimer’s Association,
the Company may be required to make revenue sharing or distribution of revenue payments for products or inventions generated or resulting
from this clinical trial program. The potential payments, although not currently defined, could result in a maximum payment of five times
(5x) the award amount of $
Contingencies – Legal
From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. As of March 31, 2024, the Company is not aware of any legal proceedings or material developments requiring disclosure.
10. Employee Benefits Plan
The Company sponsors a defined contribution employee benefit plan (the “Plan”) under the provisions of Section 401(k) of the Internal Revenue Code. The Plan covers substantially all full-time employees of the Company who are eligible upon date of hire. Contributions to the Plan by the Company are at the discretion of the Board of Directors.
The Company contributed approximately $
18
11. Loss Per Share
Basic and diluted net loss per share have been computed using the weighted-average number of shares of common stock outstanding during the period. We have outstanding stock-based awards that are not used in the calculation of diluted net loss per share because to do so would be anti-dilutive.
| Three months ended March 31, |
||||||||
| 2024 | 2023 | |||||||
| RSUs | ||||||||
| Stock options | ||||||||
| Warrants | ||||||||
| Total | ||||||||
12. Subsequent Events
On April 8, 2024, we commenced a public offering (“the Offering”)
of up to
On April 16, 2024, we entered into an inducement letter agreement (the
“Inducement Letter Agreement”) with certain holders (the “Holders”) of our existing (i) Series A Warrants
and Series B Warrants (the Series B Warrants together with the Series A Warrants the “October Warrants”), originally issued
on October 11, 2023, and thereafter amended on April 10, 2024, with an exercise price of $
Pursuant to the Inducement Letter Agreement, the Holders agreed to
exercise for cash the Warrants at an exercise price of $
The Inducement Transaction closed on April 18, 2024, and the gross
proceeds to the Company from the exercise of the Warrants, inclusive of the payment consideration for the New Warrants, were approximately
$
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
In this document, the terms “Longeveron,” “Company,” “Registrant,” “we,” “us,” and “our” refer to Longeveron Inc. We have no subsidiaries.
This Quarterly Report on Form 10-Q (this “10-Q”) contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that reflect our current expectations about our future results, performance, prospects and opportunities. This 10-Q contains forward-looking statements that can involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this 10-Q, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, future revenue, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products and prospects, plans and objectives of management are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements contained in this report include, but are not limited to, statements about:
| ● | our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; | |
| ● | our financial performance, and ability to continue as a going concern; | |
| ● |
the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements;
| |
| ● | the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; |
| ● | the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; |
| ● | the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; |
| ● | the success of competing therapies that are or may become available; |
| ● | the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; |
| ● | our ability to obtain and maintain regulatory approval of our product candidates in the U.S., Japan, the Bahamas, and other jurisdictions; |
| ● | our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; |
| ● | our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; |
| ● | the need to hire additional personnel and our ability to attract and retain such personnel; and |
| ● | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. |
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The forward-looking statements contained in this 10-Q are made on the basis of the views and assumptions of management regarding future events and business performance as of the date this 10-Q is filed with the Securities and Exchange Commission (the “SEC”). We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. We operate in a highly competitive and rapidly changing environment; therefore, new risk factors can arise, and it is not possible for management to predict all such risk factors, nor to assess the impact of all such risk factors on our business or the extent to which any individual risk factor, or combination of risk factors, may cause results to differ materially from those contained in any forward-looking statement. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements. We do not undertake any obligation to update these statements to reflect events or circumstances occurring after the date this 10-Q is filed. In addition, this discussion and analysis should be read in conjunction with our unaudited condensed financial statements and notes thereto included in this 10-Q and the audited condensed financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 27, 2024, as amended on Form 10-K/A filed with the SEC on March 11, 2024 (the “2023 10-K”). Operating results are not necessarily indicative of results that may occur in future periods.
Introduction and 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™, an allogeneic Mesenchymal Stem Cell (“MSC”) formulation sourced from the bone marrow of young, healthy adult donors. 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-related Frailty. Our mission is to advance Lomecel-B™ and other cell-based product candidates into pivotal 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™ product. Assuming that there are no third-party objections to that name, the name will be recommended for adoption by the WHO. Longeveron will adopt that name if it is recommended by the WHO.
Financial Overview. 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 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 has incurred recurring losses from operations since its inception, and as of March 31, 2024 the Company had an accumulated deficit of $89.1 million. The Company expects to continue to generate operating losses for the foreseeable future.
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With the completion of the Offerings in April 2024, we believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2024. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect. We currently have no credit facility or committed sources of capital. To continue as a going concern we will need to obtain additional capital, which we will likely obtain through a variety of means, including through public or private equity, debt financings or other sources, including up-front payments and milestone payments from strategic collaborations. To the extent that we raise additional capital through the sale of convertible debt or equity securities, current stockholder ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect stockholder rights. Such financing will likely result in dilution to stockholders, and may result in imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect our business. If we raise additional funds through up-front payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to our product candidates, or grant licenses on terms that are not favorable to us. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.
Operational Overview.
HLHS
Our HLHS program is focused on the potential clinical benefits of Lomecel-B™ as an adjunct therapeutic to standard-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-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™ 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-label study (“ELPIS I”)1 that supported the safety and tolerability of Lomecel-B™ for HLHS, when directly injected into the functional right ventricle during the second-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-free survival for patients who received 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 has resulted in acceptance by the American Heart Association (“AHA”) for a poster presentation at an AHA meeting in November 2023. The ELPIS I trial showed 100 percent survival in children up to 5 years of age after receiving 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™ both Rare Pediatric Disease (RPD”) Designation and Orphan Drug Designation (“ODD”) for treatment of infants with HLHS. Longeveron is currently conducting a controlled Phase 2b trial (“ELPIS II”) to compare the effects of Lomecel-B™ as an adjunct therapeutic versus standard-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™ as part of standard-of-care treatment in HLHS patients.
| 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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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-controlled study across ten U.S. centers. Our primary objective was to assess safety, and we tested three distinct Lomecel-BTM dosing regimens against placebo.
The study demonstrated positive results. Notably, all 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-BTM group and the pooled treatment groups compared to placebo. Other doses also indicated promising results in slowing/prevention of disease worsening. Additionally, a statistically significant improvement versus placebo was observed in the Montreal 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”). The results of the CLEAR MIND trial have been accepted for oral presentation in the Featured Research Session at the 2024 Alzheimer’s Association International Conference (“AAIC”) to be held in July 2024. The magnetic resonance imaging (“MRI”) results from this trial have also been accepted for poster presentation at AAIC. These findings support both the safety and potential therapeutic benefit of Lomecel-BTM in managing mild Alzheimer’s disease, and we believe lays a strong groundwork 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-expectancy by over a decade. This has placed tremendous strain on healthcare systems in the management of aging-related ailments and presents additional socioeconomic consequences due to a patient’s decreased independence and 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-related alterations that affect biological functioning. Our preliminary clinical data suggest that Lomecel-B™ may potentially address these problems through multiple potential mechanisms of action (“MOAs”) that simultaneously target key aging-related processes. We are using Lomecel-B™ in registry trials in The Bahamas as part of the real-world data generation for the aging population.
Summary of Clinical Development Strategy
Our core strategy is to become a world-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.
| ● | Execution of ELPIS II, a Phase 2b 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. |
| ● | 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 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.
| ● | Expand our manufacturing capabilities to commercial-scale production. 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. |
| ● | 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™ for three potential indications:
| Indication | Geography | Phase 1 | Phase 2 | Phase 3 |
| HLHS | U.S. |  |
||
| Alzheimer’s disease | U.S. |  |
||
| Aging-related Frailty* | U.S. |  |
||
Figure 1: Lomecel-B™ clinical development pipeline
| * | Not currently active for 2024 |
Hypoplastic Left Heart Syndrome (HLHS). The FDA granted 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-chamber heart into a 3-chamber one with a single ventricle (the right ventricle) supporting systemic circulation. Despite these life-saving surgeries, HLHS patients nevertheless still have high early mortality and morbidity rates due primarily to heart failure.
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We are currently conducting an ongoing Phase 2b clinical trial (ELPIS II) under FDA IND 017677. ELPIS II is a multi-center, randomized, double-blind, controlled clinical trial designed to evaluate Lomecel-B™ as an adjunct therapy to the standard-of-care second-stage HLHS heart reconstructive surgery which is typically performed at 4-6 months after birth. The primary objective is to evaluate change in right ventricular ejection fraction after Lomecel-B™ treatment versus standard-of-care surgery alone (38 subjects total: 19 per arm). This trial is over 60% 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.
ELPIS II is a next-step trial to our completed 10-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™ as an adjunct to the second-stage HLHS surgery, and to obtain preliminary evidence of Lomecel-B™ effect to support a next-phase trial. The primary safety endpoint was met: no major adverse cardiac events (“MACE”) or treatment-related infections during the first month post-treatment, and no triggering of stopping rules. Furthermore, fluid-based and imaging biomarker data supported multiple potentially relevant mechanisms-of-action of Lomecel-B™, and the potential to improve post-surgical heart function. In addition to the 12-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-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-stage surgery, rising to nearly 20% by five years. We intended to continue to follow-up with these patients for up to an additional five years, until all patients reach ten years of age.
We have filed patent applications relating to the administration of mesenchymal stem cells for treating HLHS in Australia, the Bahamas, Canada, China, the European Patent Office, Japan, South Korea, Taiwan, and the United States.
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™ treated patients showed an overall slowing/prevention of disease worsening compared to placebo in the completed Phase 2a study (CLEAR MIND Trial) as previously detailed in this report, 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.
We have filed patent applications relating to the treatment of AD using mesenchymal stem cells in Australia, the Bahamas, Canada, China, the European Patent Office, Hong Kong, Israel, Japan, New Zealand, South Korea, Singapore, South Africa, and the United States.
Aging-related Frailty. Aging-related Frailty is a life-threatening geriatric condition that disproportionately increases risks for poor clinical outcomes from disease and injury. While the definition of Aging-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-controlled Phase 2b trial which showed that a single infusion of Lomecel-B™ significantly improved 6-Minute Walk Test (“6MWT”) distance 9 months after infusion (although results were inconclusive at six months after infusion), and also showed a dose-dependent increase in 6MWT distance 6 months after infusion. The second is a multicenter, randomized, placebo-controlled Phase 1/2 trial (“HERA Trial”) intended primarily to evaluate safety, and explore the effect 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™ on signs and symptoms of Aging Frailty. Results from this study showed that Lomecel-B™ was generally safe and well tolerated in patients with Aging-related Frailty. Additionally, hemagglutinin inhibition (“HAI”) assay results in the Lomecel-B™ and placebo groups to influenza were not statistically different, indicating Lomecel-B™ does not suppress the immune system.
| 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. |
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We have filed patent applications relating to the administration of MSC for Aging-related Frailty in Australia, Canada, China, the European Patent Office, Hong Kong, Israel, Japan, Singapore, South Korea, New Zealand, South Africa, Taiwan, the Bahamas and United States.
Components of Our Results of Operations
Revenue
We have generated revenue from three sources:
| ● | Grant awards. Extramural grant award funding, which is non-dilutive, has been a core strategy for supporting our ongoing clinical research. 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, Alzheimer’s Association, and Maryland Stem Cell Research Fund. |
| ● | The Bahamas Registry Trials. Participants in The Bahamas Registry Trials pay us a fee to receive Lomecel-B™, imported into The Bahamas, and administered at one of two private medical clinics in Nassau. While Lomecel-B™ is considered an investigational product in The Bahamas, under the approval terms received from the National Stem Cell Ethics Committee, we are permitted to charge a fee for participation in the Registry Trial. The fee is recognized as revenue and is used to pay for the costs associated with manufacturing and testing of Lomecel-B™, administration, shipping and importation fees, data collection and management, biological sample collection and sample processing for biomarkers and other data, and overall management of the Registry, including personnel costs. Lomecel-B™ is considered an investigational treatment in The Bahamas and is not licensed for commercial sale. |
| ● |
Contract development and manufacturing services. From time to time, we enter into fee-for-service agreements with third parties for our product development and manufacturing capabilities. |
Cost of Revenues
We record cost of revenues based on expenses directly related to revenue. For grants we record allocated expenses for research and development costs to a grant as a cost of revenues. For the clinical trial revenue, directly related expenses for that program are allocated and accrued as incurred. These expenses are similar to those described under “Research and Development Expenses” below. For the contract manufacturing, the Company records costs incurred under the contract as cost of revenues.
Research and Development Expenses
Research and development costs are charged to expense when incurred in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 730 Research and Development. ASC 730 addresses the proper accounting and reporting for research and development costs. It identifies:
| 1. | Those activities that should be identified as research and development; |
| 2. | The elements of costs that should be identified with research and development activities, and the accounting for these costs; and |
| 3. | The financial statement disclosures related to them. |
Research and development include costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, property and equipment depreciation and allocation of various corporate costs. We accrue for costs incurred by external service providers, including contract research organizations (“CROs) and clinical investigators, based on estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, subject enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, we may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered.
We currently do not carry any inventory for our product candidates, as we have yet to launch a product for commercial distribution. Historically our operations have focused on conducting clinical trials, product research and development efforts, and improving and refining our manufacturing processes, and accordingly, manufactured clinical doses of product candidates were expensed as incurred, consistent with the accounting for all other research and development costs. Once we begin commercial distribution, all newly manufactured approved products will be allocated either for use in commercial distribution, which will be carried as inventory and not expensed, or for research and development efforts, which will continue to be expensed as incurred.
We expect that our research and development expenses will continue to be significant in the future as we increase our headcount to support increased research and development activities relating to our clinical programs, as well as incur additional expenses related to our clinical trials.
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General and Administrative Expenses
General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, business development and administrative functions. General and administrative expenses also include public company related expenses; legal fees relating to corporate matters; insurance costs; professional fees for accounting, auditing, tax and consulting services; travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs. General and administrative costs also include royalty and license fees associated with our agreements with the University of Miami as well as attending and sponsoring industry, investment, organization and medical conferences and events.
We expect that our general and administrative expenses will continue to be significant in the future as we increase our headcount to support increased administrative activities relating to our becoming a public company. We also expect to incur additional expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with Nasdaq and SEC requirements, director and officer insurance costs, and investor and public relations costs.
Other Income and Expenses
Interest income consists of interest earned on cash equivalents and marketable securities. We expect our interest income to vary in conjunction with changes in our monthly cash and marketable securities balances. Other income consists of funds earned that are not part of our normal operations. In past years they have been primarily a result of tax refunds received for social security taxes as part of a research and development tax credit program.
Income Taxes
No provision for income taxes has been recorded for the years ended December 31, 2023, and 2022. We may incur income taxes in the future if we have earnings. At this time the Company has not evaluated the impact of any future profits.
RESULTS OF OPERATIONS
COMPARISON OF THE THREE MONTHS ENDED MARCH 31, 2024 AND 2023
The following table summarizes our results of operations for the three months ended March 31, 2024 and 2023, together with the changes in those items in dollars (in thousands):
| Three Months Ended March 31, | Increase | |||||||||||
| 2024 | 2023 | (Decrease) | ||||||||||
| Revenues | $ | 548 | $ | 279 | $ | 269 | ||||||
| Cost of revenues | 219 | 203 | 16 | |||||||||
| Gross profit | 329 | 76 | 253 | |||||||||
| Expenses | ||||||||||||
| General and administrative | 2,200 | 2,012 | 188 | |||||||||
| Research and development | 2,219 | 2,780 | (561 | ) | ||||||||
| Total operating expenses | 4,419 | 4,792 | (373 | ) | ||||||||
| Loss from operations | (4,058 | ) | (4,716 | ) | 626 | |||||||
| Other income (expenses) | 32 | 69 | (37 | ) | ||||||||
| Net loss | $ | (4,058 | ) | $ | (4,647 | ) | $ | 589 | ||||
Revenues, Cost of Revenues and Gross Profit: Revenues for the three months ended March 31, 2024 and 2023 were $0.5 million and $0.3 million, respectively. 2024 revenues increased $0.2 million, or 96%, when compared to 2023 mainly as a result of increased participant demand for our Bahamas Registry Trial. Grant revenue for the three months ended March 31, 2024 and 2023 was $0 and less than $0.1 million, respectively. Clinical trial revenue, which is derived from the Bahamas Registry Trial, for the three months ended March 31, 2024 and 2023 was $0.5 million and $0.2 million, respectively. Clinical trial revenue for the three months ended March 31, 2024 increased by $0.3 million, or 116%, when compared to 2023 as a result of increased participant demand. Contract manufacturing revenue for the three months ended March 31, 2024 was less than $0.1 million and $0, respectively.
Related cost of revenues was $0.2 million for the three month periods ended March 31, 2024 and 2023. The increase of less than $0.1 million, or 8%, was primarily due to the increase in the revenues earned from the Bahamas Registry Trials and reduced direct costs associated with our grants program. This resulted in a gross profit of approximately $0.3 million for the three months ended March 31, 2024, an increase of $0.2 million, or 333%, when compared with a gross profit of $0.1 million for 2023.
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General and Administrative Expense: General and administrative expenses for the three months ended March 31, 2024 increased to approximately $2.2 million, compared to $2.0 million for the same period in 2023. The increase of approximately $0.2 million, or 9%, was primarily related to an increase in expenses related to professional fees.
Research and Development Expenses: Research and development expenses for the three months ended March 31, 2024 decreased to approximately $2.2 million, from approximately $2.8 million for the same period in 2023. The decrease of $0.6 million, or 20%, was primarily due to a decrease of $0.6 million in research and development expenses being incurred for the Alzheimer’s clinical trial and reduced costs for the aging-related frailty clinical trial following our decision to discontinue trial activities in Japan, reduced cost of supplies of $0.3 million, and a decrease of $0.2 million in equity-based compensation expenses allocated to research and development expenses. These reductions were partially offset by $0.4 million of higher compensation and benefit costs. Research and development expenses consisted primarily of the following items (less those expenses allocated to the cost of revenues for the grants) (in thousands):
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Clinical trial expenses-statistics, monitoring, labs, sites, etc. | $ | 808 | $ | 1,353 | ||||
| Supplies and costs to manufacture Lomecel-B™ | 21 | 285 | ||||||
| Employee compensation and benefits | 963 | 543 | ||||||
| Equity-based compensation | 90 | 273 | ||||||
| Depreciation | 197 | 182 | ||||||
| Amortization | 56 | 56 | ||||||
| Travel | 25 | 82 | ||||||
| Other activities | 59 | 6 | ||||||
| $ | 2,219 | $ | 2,780 | |||||
Other Income (Expense): Other income for the three months ended March 31, 2024 was less than $0.1 million. Other income consisted of less than $0.1 million from interest earned on money market funds and marketable securities. Other income for the three months ended March 31, 2023 was $0.1 million as result of gains from marketable securities.
Net Loss: Net loss decreased to approximately $4.1 million for the three months ended March 31, 2024 from a net loss of $4.6 million for the same period in 2023. The decrease in the net loss of $0.5 million, or 13%, was for the reasons outlined above.
Cash Flows
The following table summarizes our sources and uses of cash for the period presented (in thousands):
| Three months ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Net cash used in operating activities | $ | (3,086 | ) | $ | (5,848 | ) | ||
| Net cash provided by investing activities | 14 | 346 | ||||||
| Net cash provided by (used in) financing activities | 63 | (17 | ) | |||||
| Change in cash and cash equivalents | $ | (3,009 | ) | $ | (5,519 | ) | ||
Operating Activities. We have incurred losses since inception. Net cash used in operating activities for the three months ended March 31, 2024, was $3.1 million, consisting primarily of our net loss of $4.1 million and payments of $0.9 million in prepaid insurance expenses. This was partially offset by non-cash expenses of $0.3 million for equity-based compensation and $0.3 million for depreciation and amortization, and increases in accounts payable of $0.8 million, deferred revenue of $0.3 million, and accrued expenses of $0.2 million. Net cash used in operating activities for the three months ended March 31, 2023, was $5.8 million, consisting primarily of our net loss of $4.6 million, payments made to outstanding accounts payable of $1.2 million and $0.7 million in prepaid insurance expenses.
Investing Activities. Net cash provided by investing activities for the three months ended March 31, 2024, was less than $0.1 million consisting primarily of the redemption of marketable securities, which was partially offset by purchases of property and equipment and intangible assets. Net cash provided by investing activities for the three months ended March 31, 2023 was $0.3 million, consisting primarily of an increase in marketable securities, which was partially offset by additions of intangible assets and purchases of equipment.
Financing Activities. Net cash provided by financing activities for the three months ended March 31, 2024 was approximately $0.1 million for proceeds from stock subscription receivable, which was partially offset for the payment of taxes upon vesting of restricted stock units (“RSUs”). Net cash used in financing activities for the three months ended March 31, 2023 was less than $0.1 million for the payment of taxes upon vesting of RSUs.
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LIQUIDITY AND CAPITAL RESOURCES
Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses as we advance the preclinical and clinical development of our programs. We expect that our sales, research and development and general and administrative costs will increase in connection with conducting additional preclinical studies and clinical trials for our current and future programs and product candidates, contracting with CROs to support preclinical studies and clinical trials, expanding our intellectual property portfolio, and providing general and administrative support for our operations. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.
To date, we have financed our operations primarily through our IPO, public and privately placed equity financings, grant awards, and fees generated from the Bahamas Registry Trial and contract manufacturing services. Since we were formed, we have raised approximately $83.9 million in gross proceeds from the issuance of equity. At March 31, 2024, the Company had cash and cash equivalents of $1.8 million, marketable securities of $0.4 million and working capital deficit of approximately $1.5 million.
Following the capital raises in April 2024 which resulted in gross proceeds of $11.4 million and net proceeds of $10.3 million after deducting placement agent fees but before other deductions for offering expenses as discussed below, we believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2024. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect. We are actively seeking financing opportunities to extend our cash runaway while taking measures to reduce our cash expenditures as we focus our resources on our primary strategic program in HLHS. These cost saving measures include the discontinuation of our Aging-related Frailty clinical trial in Japan, related staff reductions, and continued prudent management of discretionary spend.
Capital Raising Efforts
On April 8, 2024, we commenced a public offering (“the Offering”) of up to 661,149 shares of our Class A common stock and pre-funded warrants to purchase up to an aggregate of 1,572,894 shares of our Class A common stock (the “Pre-funded Warrants”). The Class A common stock and 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 “Common Warrants”). The combined public Offering price was $2.35 per share of Class A common stock and $2.349 per Pre-funded Warrant and related Common Warrant. The Common Warrants are immediately exercisable and expire five years from the date of issuance. In connection with the Offering, the Company also entered into an agreement (the “Warrant Amendment Agreement”) with a holder (the “Holder”) of existing warrants to purchase shares of the Company’s Class A common stock, in consideration for the Holder’s participation in the Offering and purchase of securities in the Offering, and contingent upon the closing of the Offering and the Holder’s participation in the Offering, amend the Holder’s existing warrants to purchase up to (a) 242,425 shares of Class A 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 Class A 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” and together with the Series A Warrants, the “Existing Warrants”) to (i) reduce the exercise price of the Existing 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 Offering and the Series B Warrants to eighteen (18) months following the closing of the 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 placement agent fees (the “Warrant Amendment”). The Offering closed on April 10, 2024 and the gross proceeds from the Offering were $5.25 million, and net proceeds of $4.7 million after placement agent fees but before other offering expenses payable by the Company. The Warrant Amendment was effective upon the closing of the Offering.
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On April 16, 2024, we entered into an inducement letter agreement (the “Inducement Letter Agreement”) with certain holders (the “Holders”) of our existing (i) Series A Warrants and Series B Warrants (the Series B Warrants together with the Series A Warrants the “October Warrants”), originally issued on October 11, 2023, and thereafter amended on April 10, 2024, with an exercise price of $2.35 per share, and which became exercisable on December 26, 2023, and (ii) common stock warrants to purchase up to an aggregate of 1,914,984 shares of common stock, originally issued to the Holders on April 10, 2024, with an exercise price of $2.35 per share, and which were exercisable immediately following issuance (the “April Warrants” and collectively with the October Warrants, the “Warrants”).
Pursuant to the Inducement Letter Agreement, the Holders agreed to exercise for cash the Warrants at an exercise price of $2.35 per share in consideration for payment of $0.125 per new warrant and our issuance of new unregistered Common Stock Warrants (the “New Warrants”) to purchase up to 4,799,488 shares of common stock (the “New Warrant Shares”), at an exercise price of $2.35 per share (the “Inducement Transaction”), and which were immediately exercisable. The new Series C warrants to purchase 2,399,744 shares of Class A common stock have a term of five years from the issuance date, and the new Series D warrants to purchase 2,399,744 shares of Class A common stock have a term of twenty-four months from the issuance date.
The Inducement Transaction closed on April 18, 2024, and the gross proceeds to the Company from the exercise of the Warrants, inclusive of the payment consideration for the New Warrants, were approximately $6.2 million, and net proceeds of $5.6 million after deducting placement agent fees but before other offering expenses payable by the Company.
Grant Awards
From inception through December 31, 2023, we have been awarded approximately $11.9 million in governmental and non-profit association grants, which have been used to fund our clinical trials, research and development, production and overhead. Grant awards are recognized as revenue, and depending on the funding mechanism, are deposited directly in our accounts as lump sums, which are staggered over a predetermined period or drawn down from a federal payment management system account for reimbursement of expenses incurred. Revenue recognition occurs when the grant related expenses are incurred or supplies and materials are received. As of March 31, 2024, and December 31, 2023, the amount of unused grant funds that were available for us to draw was approximately $0.1 million.
Terms and Conditions of Grant Awards
Grant projects are typically divided into periods (e.g., a three-year grant may have three one-year periods), and the total amount awarded is divided according to the number of periods. At pre-specified time points, which are detailed in the grant award notifications, we are required to submit interim financial and scientific reports to the granting agency totaling funds spent, and in some cases, detailing use of proceeds and progress made during the reporting period. After funding the initial period, receipt of additional grant funds is contingent upon satisfactory submission of our interim reports to the granting agency.
Grant awards arise from submitting detailed research proposals to granting agencies, and winning a highly competitive and rigorous application review and process that is judged on the merits of the proposal. There are typically multiple applicants applying and competing for a finite amount of funds. As such we cannot be sure that we will be awarded grant funds in the future despite our past success in receiving such awards.
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Funding Requirements
Our operating costs will continue to be substantial for the foreseeable future in connection with our ongoing activities. In past years we have been able to fund a large portion of our clinical programs and our administrative overhead with the use of grant funding.
Specifically, our expenses will increase as we:
| ● | advance the clinical development of Lomecel-B™ for the treatment of several disease states and indications; |
| ● | pursue the preclinical and clinical development of other current and future research programs and product candidates; |
| ● | in-license or acquire the rights to other products, product candidates or technologies; |
| ● | maintain, expand and protect our intellectual property portfolio; |
| ● | hire additional personnel in research, manufacturing and regulatory and clinical development as well as management personnel; |
| ● | seek regulatory approval for any product candidates that successfully complete clinical development; and |
| ● | expand our operational, financial and management systems and increase personnel, including personnel to support our operations as a public company. |
We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2024. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect. We are actively seeking financing opportunities to extend our cash runaway while taking measures to reduce our cash expenditures as we focus our resources on our primary strategic program in HLHS. These cost saving measures include the discontinuation of our Aging-related Frailty clinical trial in Japan, related staff reductions, and continued prudent management of discretionary spend.
Because of the numerous risks and uncertainties associated with research, development and commercialization of our product candidates, it is difficult to estimate with certainty the amount of our working capital requirements. Our future funding requirements will depend on many factors, including:
| ● | the progress, costs and results of our clinical trials for our programs for our cell-based therapies, and additional research and preclinical studies in other research programs we initiate in the future; |
| ● | the costs and timing of process development and manufacturing scale-up activities associated with our product candidates and other programs we advance through preclinical and clinical development; |
| ● | our ability to establish and maintain strategic collaborations, licensing or other agreements and the financial terms of such agreements; |
| ● | the extent to which we in-license or acquire rights to other products, product candidates or technologies; and |
| ● | the costs and timing of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property-related claims. |
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Further, our operating results may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans. Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of equity offerings, debt financings, grant awards, collaboration agreements, other third-party funding, strategic alliances, licensing arrangements and marketing and distribution arrangements.
We currently have no credit facility or committed sources of capital. Debt financing and preferred equity financing, if available, 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 additional funds through other third-party funding, collaboration agreements, strategic alliances, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our biologic drug development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.
In order to meet our operational goals, we will need to obtain additional capital, which we will likely obtain through a variety of means, including through public or private equity, debt financings or other sources, including up-front payments and milestone payments from strategic collaborations. To the extent that we raise additional capital through the sale of convertible debt or equity securities, current stockholder ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. Such financing may result in dilution to stockholders, and may result in imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect our business. If we raise additional funds through up-front payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to our product candidates, or grant licenses on terms that are not favorable to us. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.
Contractual Obligations and Commitments
As of March 31, 2024, we have $1.9 million in operating lease obligations and $1.4 million in contract research organization obligations. We enter into contracts in the normal course of business with third-party contract organizations for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore we believe that our non-cancelable obligations under these agreements are not material.
We have not included milestone or royalty payments or other contractual payment obligations if the timing and amount of such obligations are unknown or uncertain.
Critical Accounting Estimates
For a discussion of our critical accounting estimates, refer to “Management’s Discussion and Analysis of Results of Operations and Financial Condition” in Part II, Item 7 and the notes to our financial statements in Part II, Item 8 of our 2023 Form 10-K. See also Note 1 to the condensed financial statements. There have been no material changes to our critical accounting estimates since the filing of our 2023 Form 10-K.
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Emerging Growth Company Status
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, or JOBS Act, which is a law intended to encourage funding of small businesses in the U.S. by easing many of the country’s securities regulations, and we may take advantage of reduced reporting requirements that are otherwise applicable to public companies. Section 107 of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies are required to comply with those standards. We have elected to take advantage of the extended transition period for complying with new or revised accounting standards; and as a result of this election, our condensed financial statements may not be comparable to companies that comply with public company effective dates. The JOBS Act also exempts us from having to provide an auditor attestation of internal control over financial reporting under Sarbanes-Oxley Act Section 404(b).
We will remain an “emerging growth company” until the earliest of (1) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more, (2) the last day of the fiscal year following the fifth anniversary of the completion of our IPO, (3) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC, which generally is when a company has more than $700 million in market value of its reported class of stock held by non-affiliates and has been a public company for at least 12 months and have filed at least one Annual Report on Form 10-K.
Recent Accounting Pronouncements
A description of recent accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our unaudited condensed financial statements included in Item 1 of this 10-Q.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
There were no material changes in our exposure to market risk since the disclosure included in Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2023 10-K.
Item 4. Controls and Procedures.
Disclosure controls and procedures
Our management, under the supervision of and with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as of the end of the period covered by this Quarterly Report on Form 10-Q. Based upon this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective.
Changes in internal control over financial reporting
There were no changes in our internal control over financial reporting that occurred during the fiscal quarter ended March 31, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. As of March 31, 2024, the Company is not aware of any legal proceedings or material developments requiring disclosure.
Item 1A. Risk Factors.
There have been no material changes to the risk factors affecting the Company from those disclosed in the 2023 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
ISSUER PURCHASES OF EQUITY SECURITIES
| Period | Total Number of Shares Purchased (a) | Average (b) | Total (c) | Dollar (d) | ||||||||||||
| January 1-31, 2024 | 14,147 | $ | 1.32 | - | - | |||||||||||
| February 1-29, 2024 | 2,869 | 0.53 | - | - | ||||||||||||
| March 1-31, 2024 | 33,293 | 0.54 | - | - | ||||||||||||
| Total | 50,309 | $ | 0.76 | - | - | |||||||||||
| (a) | Includes shares withheld from employees to satisfy minimum tax withholding obligations associated with the vesting of restricted stock and performance stock units during the period. |
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Trading Arrangements
Rock Soffer, a member of the Company’s Board of Directors, adopted a “Rule 10b5-1 trading arrangement” during the Company’s fiscal quarter ended March 31, 2024. The trading arrangement, adopted January 11, 2024, and effective January 12, 2024, is intended to satisfy the affirmative defense of Rule 10b5-1(c). The trading arrangement will remain in place per its terms until the earlier of (a) April 17, 2025; (b) completion of the sale of 275,000 shares of Longeveron Class A common stock; (d) notice or awareness of the closing of a tender or exchange offer or a merger, acquisition, reorganization, recapitalization, or comparable transaction for Longeveron in which its capital stock is exchanged or converted; (e) the death, incapacity, bankruptcy, or insolvency of Mr. Soffer; or (e) such other termination in accordance with its terms.
Other than Mr. Soffer, none of the Company’s other directors
or “officers,” as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
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Item 6. Exhibits.
| * | Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish copies of any of the omitted schedules upon request by the SEC. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| LONGEVERON INC. | |
| Date: May 14, 2024 | /s/ Mohamed Wa’el Ahmed Hashad |
| Mohamed Wa’el Ahmed Hashad | |
| Chief Executive Officer | |
| (principal executive officer) |
| Date: May 14, 2024 | /s/ Lisa A. Locklear |
| Lisa A. Locklear | |
| Executive Vice President and Chief Financial Officer | |
| (principal financial and accounting officer) |
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