Longeveron Inc 10-Q for FY2022 Q2
Longeveron Inc. (LGVN)
About this 10-Q
Longeveron Inc filed this 10-Q on August 12, 2022, covering the quarter ended June 30, 2022 (FY2022 Q2).
Headline figures
Quarter ended June 30, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $466K
- down 4.7% from $489K a year earlier
- Net loss
- $5.62M
- compared with a net loss of $5.01M a year earlier
- Diluted EPS
- -$0.27
- compared with -$0.26 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
For the quarterly
period ended
OR
For the transition period from to .
Commission file
number:
(Exact name of registrant as specified in its charter)
(State or Other Jurisdiction of Incorporation) | (IRS Employer Identification No.) |
(Address of Principal Executive Offices)
Registrant’s
Telephone Number, Including Area Code:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||
| The |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days.
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ | ||||
| ☒ | Smaller reporting company | ||||||
| Emerging growth company | |||||||
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 12, 2022, the registrant
had
LONGEVERON INC.
TABLE OF CONTENTS
i
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
Longeveron Inc.
Condensed Balance Sheets
(In thousands, except share and per share data)
| June 30, 2022 | December 31, 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Short-term investments at fair value (cost of $ | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Accounts and grants receivable | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Intangible assets, net | ||||||||
| Right-of-use (ROU) asset | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Current portion of lease liability | ||||||||
| Estimated lawsuit liability | - | |||||||
| Deferred revenue | ||||||||
| Total current liabilities | ||||||||
| Long-term liabilities: | ||||||||
| Lease liability | ||||||||
| 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 | ( | ) | ( | ) | ||||
| 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 June 30, | Six
months ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenues | ||||||||||||||||
| Clinical trial revenue | $ | $ | $ | $ | ||||||||||||
| Grant revenue | ||||||||||||||||
| Total revenues | ||||||||||||||||
| Cost of revenues | ||||||||||||||||
| Gross profit | ||||||||||||||||
| Operating expenses | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other (expense) and income | ||||||||||||||||
| Non-operating Lawsuit expense | ( | ) | ( | ) | ||||||||||||
| Forgiveness of Paycheck Protection Program loan | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ||||||||||||
| Other expense, net | ( | ) | ( | ) | ||||||||||||
| Total other income and (expenses), net | ( | ) | ( | ) | ||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||
See accompanying notes to unaudited condensed financial statements.
2
Longeveron Inc.
Condensed Statements of Member’s Equity and Stockholders’ Equity
For the Three
and Six Months Ended June 30, 2022 and 2021
(In Thousands, Except Share Amounts)
(Unaudited)
| Series A Units | Series B Units | Series C Units | Class
A Common Stock | Class
B Common Stock | Additional | |||||||||||||||||||||||||||||||||||||||||||||||||||
Number
of | Amount | Number
of Units | Amount | Number
of | Amount | Number | Amount | Number | Amount | Subscription Receivable | Paid-In Capital | Accumulated Deficit | Total Equity | |||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2021 | - | $ | - | $ | - | $ | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||
| 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 consulting | - | - | - | ( | ) | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Class A Common Stock Options Exercised | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity-based compensation | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2022 | - | $ | - | $ | - | $ | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||
| Series A Units | Series B Units | Series C Units | Class
A Common Stock | Class
B Common Stock | Additional | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Number
of Units | Amount | Number
of Units | Amount | Number
of Units | Amount | Number | Amount | Number | Amount | Subscription
Receivable | Paid-In Capital | Accumulated
Deficit | Total
Equity | |||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2020 | $ | $ | ( | ) | $ | - | $ | - | - | $ | - | $ | ( | ) | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||
| Conversion of Units into Class A and B common stock | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||
| Initial public offering and overallotment of Class A Common Stock, net of $ | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Class A Common Stock, issued for consulting | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity-based compensation | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2021 | - | $ | - | $ | - | $ | - | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||
See accompanying notes to unaudited condensed financial statements.
3
Longeveron Inc.
Condensed Statements of Member’s Equity and Stockholders’ Equity
For the Three and Six Months Ended June 30, 2022 and 2021
(In Thousands, Except Share Amounts)
(Unaudited)
| Series A Units | Series B Units | Series C Units | Class
A Common Stock | Class
B Common Stock | Additional | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Number
of Units | Amount | Number
of Units | Amount | Number
of Units | Amount | Number | Amount | Number | Amount | Subscription Receivable | Paid-In Capital | Accumulated Deficit | Total Equity | |||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2022 | - | $ | - | $ | $ | - | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||
| 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 consulting | - | - | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Class A Common Stock Options Exercised | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity-based compensation | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2022 | - | $ | - | $ | - | $ | - | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||
| Class A | Class B | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Series A Units | Series B Units | Series C Units | Common Stock | Common Stock | Additional | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Number of Units | Amount | Number of Units | Amount | Number of Units | Amount | Number of Units | Amount | Number of Units | Amount | Subscription Receivable | Paid-In Capital | Accumulated Deficit | Total Equity | |||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2021 | - | $ | - | $ | - | $ | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||
| Class A Common Stock, issued for consulting | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity-based compensation | - | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2021 | - | $ | - | $ | - | $ | - | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||
See accompanying notes to unaudited condensed financial statements.
4
Longeveron Inc.
Condensed Statements of Cash Flows
(In thousands)
(Unaudited)
| Six months ended June 30, | ||||||||
| 2022 | 2021 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Forgiveness of Paycheck Protection Program loan | ( | ) | ||||||
| Change in fair value of short-term investments | ( | ) | ||||||
| Equity issued for consulting services | ||||||||
| Equity-based compensation | ||||||||
| Non-operating Lawsuit expense | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts and grants receivable | ( | ) | ||||||
| Prepaid expenses and other current assets | ( | ) | ( | ) | ||||
| Other assets | ( | ) | ||||||
| Accounts payable | ( | ) | ( | ) | ||||
| Deferred revenue | ||||||||
| Accrued expenses | ( | ) | ( | ) | ||||
| ROU asset and lease liability | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Proceeds from the sale (purchases) of short-term investments | ( | ) | ||||||
| Acquisition of property and equipment | ( | ) | ||||||
| Acquisition of intangible assets | ( | ) | ( | ) | ||||
| Net cash provided by (used in) investing activities | ( | ) | ||||||
| Cash flows from financing activities | ||||||||
| Proceeds from initial public offering of common stock, net of commissions and expenses | ||||||||
| Payments for taxes on RSUs vested | ( | ) | ||||||
| Repayments of short-term note payable | ( | ) | ||||||
| Net cash (used in) provided by 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: | ||||||||
| Conversion of Series A, B and C units into Class A and B common stock | $ | $ | ( | ) | ||||
| Vesting of RSUs into Class A Common Stock | $ | ( | ) | $ | ||||
See accompanying notes to unaudited condensed financial statements.
5
Longeveron Inc.
Notes to the Condensed Financial Statements (Unaudited)
Three and Six Month Periods Ended June 30, 2022 and 2021
1. Nature of Business, Basis of Presentation, and Liquidity
Nature of business:
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”). Longeveron, LLC was formed as a Delaware limited liability company on October 9, 2014 and was authorized to transact business in Florida on December 15, 2014. 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 Condensed Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). These Condensed Financial Statements and Notes should be read in conjunction with the Financial Statements and Notes thereto in the Company’s 2021 Form 10-K Annual Report.
Initial Public Offering (“IPO”):
The Corporate Conversion
undertaken immediately prior to the Company’s IPO caused all existing Series A and B units to convert into Class B Common Stock,
par value $
On February 12,
2021 our Class A Common Stock, par value $
On March 15, 2021,
the Company’s underwriters partially exercised the over-allotment option, resulting in the Company selling an additional
Private Placement
On December 3,
2021, the Company completed a private placement with several investors, wherein a total of
6
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 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 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 $
As of June 30,
2022, the Company had cash, and cash equivalents of $
2. Summary of Significant Accounting Policies
Basis of presentation:
The financial statements of the Company were prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”).
Certain reclassifications have been made to prior year financial statements to conform to classifications used in the current year. These reclassifications had no impact on net loss, shareholders’ equity or cash flows as previously reported.
Use of estimates:
The presentation of 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 financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Accounting Standard Updates
In December 2019, the FASB issued ASU 2019-12, “Income Taxes (Topic 740).” The amendments in this ASU simplify the accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and by clarifying and amending other areas of Topic 740. The amendments in this ASU are effective for annual and interim periods beginning after December 15, 2020. We adopted this ASU on January 1, 2021 with no material impact on our financial statements.
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 financial statements.
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.
Short-term investments:
Short-term investments at June 30, 2022 and December 31, 2021 consisted of marketable fixed income securities, primarily corporate bonds, as well as U.S. Government and agency obligations which are categorized as trading 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. 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 statement of operations. Changes in net unrealized gains and losses are reported in the statement of operations within other income and losses, in the current period and represent the change in the fair value of investment holdings during the reporting period. Changes in net unrealized gains and losses were not significant for the three and six months ended June 30, 2022 and 2021.
7
Accounts and grants receivable:
Accounts and grants receivable include amounts due from customers, granting institutions and others. The amounts as of June 30, 2022 and December 31, 2021 are certain to be collected, and no amount has been recognized for doubtful accounts. Maryland-TEDCO generally advances grant funds and therefore a receivable is not usually recognized. 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.
Accounts and grants receivable by source, as of (in thousands):
| June 30, 2022 | December 31, 2021 | |||||||
| National Institutes of Health – Grant | $ | $ | ||||||
| Total | $ | $ | ||||||
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 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 Statement 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 on the statements of operations. Upon evaluation, management determined that there was no impairment of long-lived assets during the three and six months ended June 30, 2022 and 2021.
Deferred revenue:
The unearned portion
of advanced grant funds and prepayments for Clinical trial revenue, which will be recognized as revenue when the Company meets the respective
performance obligations, has been presented as deferred revenue in the accompanying balance sheets. For the six months ended June 30,
2022 and 2021, 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.
8
Revenue by source (in thousands):
| Three
months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| National Institute of Health - grant | $ | $ | $ | $ | ||||||||||||
| Clinical trial revenue | ||||||||||||||||
| Alzheimer’s Association grant | - | |||||||||||||||
| MSCRF – TEDCO1 - grant | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
| 1 |
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.
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, short-term investments 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:
Prior to its Corporate Conversion, the Company was treated as a partnership for U.S. federal and state income tax purposes. Consequently, the Company passed its earnings and losses through to its members based on the terms of the Company’s Operating Agreement. Accordingly, no provision for income taxes is recorded in the financial statements for periods prior to the conversion.
Following the
Corporate Conversion, 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 June 30, 2022 and December 31, 2021, 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.
9
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 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 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 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 option was granted. The expected life is
the period of time that the options granted are expected to remain outstanding. Options granted have a maximum term of
Comprehensive Loss
Comprehensive loss was equal to net loss for the three and six months ended June 30, 2022 and 2021.
3. Short-term investments
The following is summary of short-term investments that the Company measures at fair value:
| Fair Value at June 30, 2022 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| U.S. Treasury obligations | ||||||||||||||||
| U.S. government agencies | ||||||||||||||||
| Corporate and foreign bonds | ||||||||||||||||
| Money market funds(1) | ||||||||||||||||
| Total short-term investments | $ | $ | $ | $ | ||||||||||||
| (1) |
| Fair Value at December 31, 2021 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| U.S. Treasury obligations | ||||||||||||||||
| U.S. government agencies | ||||||||||||||||
| Corporate and foreign bonds | ||||||||||||||||
| Money market funds(1) | ||||||||||||||||
| Total short-term investments | $ | $ | $ | $ | ||||||||||||
| (2) |
As of June 30,
2022 and December 31, 2021, the Company reported accrued interest receivable related to short-term investments of $
10
4. Property and equipment, net
Major components of property and equipment are as follows (in thousands):
| Useful Lives | June 30, 2022 | December 31, 2021 | ||||||||
| 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
Major components of intangible assets as of June 30, 2022 are as follows (in thousands):
| Useful Lives | Cost | Accumulated Amortization | Total | |||||||||||
| License agreements | | $ | $ | ( | ) | $ | ||||||||
| Patent Costs | ||||||||||||||
| Trademark costs | ||||||||||||||
| Total | $ | $ | ( | ) | $ | |||||||||
Major components of intangible assets as of December 31, 2021 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 $
Future amortization expense for intangible assets as of June 30, 2022 is approximately as follows (in thousands):
| Year Ending December 31, | Amount | ||||
| 2022 (remaining six months) | $ | ||||
| 2023 | |||||
| 2024 | |||||
| 2025 | |||||
| 2026 | |||||
| Thereafter | |||||
| Total | $ | ||||
11
6. Leases
The Company records
a Right-of-use (ROU) 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 June 30, 2022, the ROU asset and lease liability were approximately $
Future minimum payments under the operating leases as of June 30, 2022 are as follows (in thousands):
| Year Ending December 31, | Amount | ||||
| 2022 (remaining six months) | $ | ||||
| 2023 | |||||
| 2024 | |||||
| 2025 | |||||
| 2026 | |||||
| Thereafter | |||||
| Total | |||||
| Less: Interest | |||||
| Present Value of Lease Liability | $ | ||||
During each of
the three and six months ended June 30, 2022 and 2021, the Company incurred approximately $
On July 1, 2020,
the Company entered into a sublease agreement for a portion of its leased space for a one-year period ending June 30, 2021, with optional
-year renewal periods, and $
7. Stockholders’ Equity
Class A Common Stock
On June 22, 2022,
a total of
On June 3, 2022,
a total of
On April 4, 2022,
a total of
On April 1, 2022,
a total of
On April 1, 2022,
a total of
On February 12,
2022, a total of
12
On January 3, 2022,
a total of
During the year
ended December 31, 2021, and prior to the Corporate Conversion, the Company issued
Also, during the
year ended December 31, 2021, the Company issued
During the six
months ended June 30, 2022,
During the year
ended December 31, 2021,
On October 1, 2021,
a total of
Class B Common Stock
In connection with
the Corporate Conversion,
During the six
months ended June 30, 2022, shareholders exchanged
Warrants
As part of the
IPO, the underwriter received warrants to purchase
As part of the
November 2021 private placement, the Company issued
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.
On June 22, 2022, the Company granted $
13
On June 3, 2022, the Company granted a bonus to
Mr. Clavijo and Mr. Lehr in the form of RSUs. Mr. Clavijo and Mr. Lehr were granted
On April 4, 2022,
On July 20, 2021, the Company granted a bonus
for the completion of the IPO to Mr. Green, Mr. Lehr and Dr. Hare of $
As of June 30, 2022 and December 31, 2021, the
Company had
RSU activity for the six months ended June 30, 2022 was as follows:
| Number of RSUs | ||||
| Outstanding (unvested) at December 31, 2021 | ||||
| RSU granted | ||||
| RSUs vested | ( | ) | ||
| RSU expired/forfeited | ( | ) | ||
| Outstanding (unvested) at June 30, 2022 | ||||
Stock Options
Stock options may be granted under the 2021 Incentive
Plan. The exercise price of options is equal to the fair market value of the Company’s Class A Common Stock as of the grant date.
Options historically granted have generally become exercisable over four years and expire ten years from the date of grant. The 2021 Incentive
Plan provides for equity grants to be granted up to
The fair value of the options issued are estimated
using the Black-Scholes option-pricing model and have the following assumptions: a dividend yield of
As of June 30, 2022, the Company has recorded
issued and outstanding options to purchase a total of
For the six months ended June 30, 2022:
| Number of Stock Options | ||||
| Stock options vested (based on ratable vesting) | ||||
| Stock options unvested | ||||
| Total stock options outstanding at June 30, 2022 | ||||
For the year ended December 31, 2021:
| Number of Stock Options | ||||
| Stock options vested (based on ratable vesting) | ||||
| Stock options unvested | ||||
| Total stock options outstanding at December 31, 2021 | ||||
14
Stock Option activity for the six months ended June 30, 2022 was as follows:
Number of Stock | Weighted Exercise | |||||||
| Outstanding at December 31, 2021 | $ | |||||||
| Options granted | $ | |||||||
| Options exercised | ( | ) | $ | |||||
| Options expired/forfeited | ( | ) | $ | |||||
| Outstanding at June 30, 2022 | $ | |||||||
On June 3, 2022, the Company granted an award
of
On March 14, 2022, the Company granted an award
of
On January 6, 2022, the Company granted awards
of
For the six months ended June 30, 2022 and 2021,
the equity-based compensation expense amounted to approximately $
As of June 30, 2022, the remaining unrecognized
equity-based compensation (which includes RSUs and stock options) of approximately $
9. Commitments and Contingencies
Master Services Agreements:
As of June 30, 2022, 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
$
As of December
31, 2021, 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 on behalf of the Company. On March 10, 2022, the Company entered into a clinical studies
agreement with a third party in conjunction with an upcoming clinical trial in Japan. The agreement provides for payments totaling $
Consulting Services Agreements:
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 $
On February 16, 2022, the Company entered into a ten-month extension
to a consulting arrangement with GVC Strategies a Company owned by Neil Hare, a member of the Board of Directors and brother of Dr. Joshua
Hare, to provide public relations services. Under the terms of this agreement GVC Strategies receives a $
15
Technology Services Agreement:
On March 27, 2015, the Company entered into a
technology services agreement with Optimal Networks, Inc. (a related company owned by a Dr. Joshua Hare’s brother-in-law) for use
of information technology services. The Company agreed to issue the related party equity incentive units in the amount equal to
Exclusive Licensing Agreements:
UM Agreement
On November 20, 2014, the Company entered into
an exclusive license agreement with UM for the use of certain stem cell aging-related frailty technology rights developed by the CSO while
employed at UM. The Company recorded the value of the membership units issued to obtain this license agreement as an intangible asset.
The UM agreement was further amended on March
3, 2021 to increase the license fee due to UM. The Company agreed to pay UM an additional fee, which will be recorded as legal costs,
of $
CD271
On December 22, 2016, the Company entered into
an exclusive license agreement with an affiliated entity of Dr. Joshua Hare, 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.
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.
16
Contingencies – Legal
On September 13, 2021, the Company and certain
of our directors and officers were named as defendants in a securities lawsuit filed in the U.S. District Court for the Southern District
of Florida and brought on behalf of a purported class. The suit alleges there were materially false and misleading statements made (or
omissions of required information) in the Company’s initial public offering materials and in other disclosures during the period
from our initial public offering on February 12, 2021, through August 12, 2021, in violation of the federal securities laws. The action
seeks damages on behalf of a proposed class of purchasers of our Common Stock during said period. The Company entered into an agreement
in principle with the plaintiffs to settle the litigation for $
Contingencies – COVID-19 Pandemic
The COVID-19 outbreak has adversely impacted and could continue to adversely impact the Company’s ability to conduct business in the future. In December 2019, it was first reported that there had been an outbreak of a novel strain of coronavirus, SARS-CoV-2, COVID-19, in China. As the COVID-19 pandemic has evolved, national and local governments enacted various measures, including travel restrictions or bans, restrictions on events or gatherings, temporary closure of non-essential businesses, “social distancing” requirements, vaccine and mask mandates, and various other requirements designed to slow the spread of COVID-19. While many of these measures have been eased, the extent, severity, and overall duration of the pandemic, including its phases of resurgence and the introduction of new variants, some of which may be more transmissible or virulent, are unknown. The impacts and potential impacts from the COVID-19 pandemic and associated protective measures that have had, continue to have, or could directly or indirectly have, a material adverse effect on our business include:
| ● | impact to the financial markets; | |
| ● | disruption in the ability to provide product in foreign markets; | |
| ● | disruption in the ability to source materials; | |
| ● | disruption in the ability to manufacture our product; | |
| ● | delays or difficulties in completing the Company’s regulatory work; | |
| ● | limitations on the Company’s employee resources ability to work, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; and | |
| ● | additional repercussions on the Company’s ability to operate its business. |
The global outbreak of COVID-19 continues to evolve. The extent to which COVID-19 will continue to impact the Company’s results will depend on future developments, which are highly uncertain and cannot be predicted, and the Company cannot provide any assurance that the ongoing pandemic will not have a material adverse impact on the Company’s operations or future results, or filings with regulatory health authorities.
The Company continues to monitor how the COVID-19 pandemic is affecting the Company’s employees, business, and clinical trials. In response to the spread of COVID-19, the Company instructed all employees who could perform their essential employment duties from home to do so. The Company’s laboratory scientists, cell processing scientists and other manufacturing personnel continued to work from the Company GMP facility on a day-to-day basis, and as such cell production was minimally impacted. When the pandemic began to emerge in the U.S., most of the Company’s ongoing clinical trials had completed enrollment, however a few subjects that were currently on study and in follow-up experienced some difficulties in adhering to the protocol schedule. Because the Company primarily enrolls elderly subjects in the trials, who are at particular risk for poor outcomes related to COVID-19 infection, the Company experienced some disruption in executing the follow-up visits in Company protocols and the Company may continue to experience difficulty in enrolling elderly subjects in upcoming trials due to ongoing risk. While the Company believes the number of instances where a visit was missed completely is small, the Company cannot predict whether this will have a material impact on the Company clinical results in the future. If too many subjects drop-out or the protocol is no longer effective, the Company may have to restart the clinical trial entirely.
17
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 have completed one year of service. Contributions to the Plan by the Company are at the discretion of the Board of Directors.
The Company contributed approximately $
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.
The following instruments (in thousands) were excluded from the calculation of diluted net loss per share because their effects would be antidilutive:
| Six months ended June 30, | ||||||||
| 2022 | 2021 | |||||||
| Equity awards | ||||||||
| Warrants | ||||||||
| Total | ||||||||
12. Subsequent Events
During July 2022, outstanding rent payments due
from a sublease agreement of approximately $
18
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
In this document, the terms “Longeveron,” “Company,” “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 report, 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:
| ● | 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; | |
| ● | our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; | |
| ● | existing regulations and regulatory developments in the United States, Japan and other jurisdictions; | |
| ● | 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; | |
| ● | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; | |
| ● | the effect that global pathogens could have on financial markets, materials sourcing, patients, governments and population (e.g., COVID-19); | |
| ● | our 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 | |
| ● | 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 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”). In addition, 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. 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 financial statements and notes thereto included in this 10-Q and the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 11, 2022 (“2021 10-K”). Operating results are not necessarily indicative of results that may occur in future periods.
19
Overview and Recent Developments
Overview
We are a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. Our lead investigational product is the LOMECEL-B™ cell-based therapy product (“Lomecel-B”), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other conditions.
We are currently sponsoring or have sponsored Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer’s disease (AD), Acute Respiratory Distress Syndrome (ARDS), and Hypoplastic Left Heart Syndrome (HLHS). In addition, there is a biomarker sub-study of Metabolic Syndrome using data from the Adult Frailty Phase 2b study. 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.
Our philosophy is that healthy aging can be improved through regenerative medicine approaches. Life expectancy has substantially increased over the past century as a result of medical and public health advancements. However, this increase in longevity has not been paralleled by the number of years a person is expected to live in relatively good health, with limited chronic disease and disabilities of aging – a period known as healthspan. 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 declines. Our preliminary clinical data suggest that Lomecel-B can potentially address these problems through multiple mechanisms of action, or MOAs, that simultaneously target key aging-related processes.
Improving healthspan is an imperative for governmental health agencies. The National Institute on Aging (NIA), an institute of the National Institutes of Health (NIH), has promoted the concept of geroscience – the idea that aging itself is the biggest risk factor for aging-related human diseases and that aging can be approached as a treatable disease to improve healthspan. The geroscience hypothesis provides a strong rationale for the approach of treating underlying biological processes contributing to aging as a way to reduce disease burden and advance global human health. Our investments into developing and testing product candidates are aimed at reducing aging-related disease burden and improving healthspan.
20
Our Strategy
Our core business strategy is to become a world leading regenerative medicine company through the development and commercialization of novel cell therapy products for unmet medical needs, with emphasis on aging-related indications. Key elements of our business strategy are as follows.
| ● | Advance Lomecel-B and other regenerative medicine products to market. We are advancing Lomecel-B into later stage clinical trials for the purpose of achieving commercialization in one or more indications. Our studies throughout the clinical development process are intended to generate safety and efficacy data needed to advance these programs, and establish foundations for subsequent development and expansion into new areas. We will continue to leverage our technical and clinical expertise, and relationships with clinical investigators, treatment centers, and other key stakeholders, to explore new opportunities. |
| ● | Expand our manufacturing capabilities to commercial-scale production. We operate a good manufacturing practice (GMP) – 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 should Lomecel-B achieve commercialization. |
| ● | Non-dilutive funding. Our clinical programs have received over $16.0 million in competitive extramural grant awards ($11.9 million which has been directly awarded to us and which are recognized as revenue when the performance obligations are met) from the NIH, Alzheimer’s Association, and Maryland Stem Cell Research Fund (MSCRF). These prestigious funding awards are non-dilutive and allow us to collaborate with state and federal partners in pursuing safe and effective therapeutics for disorders that have few, if any, available approved treatments. |
| ● | Continue to develop our existing international programs. We have selected Japan as our first non-U.S. territory for a randomized, double-blinded, placebo-controlled clinical trial to evaluate Lomecel-B for Aging Frailty. We may explore other indications in Japan, and potentially pursue Aging Frailty and other indications in additional international locations for further development and commercialization. |
| ● | Collaboration arrangements and out-licensing opportunities. We will be opportunistic and consider entering into co-development, out-licensing, commercialization or other collaboration agreements for the purpose of commercializing Lomecel-B and other products domestically and internationally. |
| ● | 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 continue to actively explore promising potential additions to our pipeline of product candidates. |
| ● | Continue to expand our intellectual property portfolio. Our intellectual property is vitally important to our business strategy, and we 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. |
21
Impact of COVID-19 Pandemic and other Macroeconomic Conditions
We continue to monitor how the COVID-19 pandemic is affecting our employees, business, and clinical trials. During the initial stages associated with the spread of COVID-19, we instructed all employees who could perform their essential employment duties from home to do so. Our laboratory scientists, cell processing scientists and other manufacturing personnel continued to work from our GMP facility and headquarters on a day-to-day basis, and as such cell production was minimally impacted. When the pandemic began to emerge in the U.S., most of our ongoing clinical trials had completed enrollment. However, a few subjects that were then on study and in follow-up experienced some difficulties in adhering to the protocol schedule. Because we primarily enroll elderly subjects in our trials, who are at particular risk for poor outcomes related to COVID-19 infection, we experienced some disruption in executing the follow-up visits in our studies. These disruptions resulted from many challenges that included temporary clinical site closures, the inability to leave a residence due to regional “stay-at-home” orders and an unwillingness of trial subjects to leave their residence to visit the hospital or clinic. To minimize and mitigate these disruptions, we by conducted remote visits (telemedicine), arranged for in-home visits for phlebotomy in order to collect blood samples and perform protocol-specific assessments, and amended protocols to increase the window of time for follow-up visits. Despite these efforts, several subjects missed follow up visits, had their follow up visit outside of the protocol-defined time-window, or withdrew from the trial prior to completion. Regardless, given the steps implemented by Longeveron, the cumulative instances were few and did not appear to have a material impact on from our now-completed Phase 2b Aging Frailty study, Phase 1 Alzheimer’s disease trial, and HLHS trial.
In July 2020 the Bahamian government halted travel from the U.S. into The Bahamas, which resulted in the temporary cessation of participation in The Bahamas Registry Trial. While this travel restriction has since been lifted, participation in the Registry Trial remains lower than anticipated, due in part to pandemic-related effects on international travel.
Presently, several Longeveron employees continue to work from home either full time, or through a hybrid schedule, and we anticipate that this will continue for the foreseeable future. We expect that the COVID-19 pandemic may continue to impact our business, results of operations, clinical development timelines and financial condition. At this time, there is significant uncertainty relating to the trajectory of the COVID-19 pandemic and impact of related responses. The impact of COVID-19 on our future results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic concentration and continued spread of the disease, the duration of the pandemic, travel restrictions to and social distancing within the United States and other countries, business closures or business disruptions, the continued impact on financial markets and the global economy, and the effectiveness of the global response to contain and treat the disease.
As it relates to current macroeconomic conditions in the U.S., although we have experienced some supply constraints and marginal price increases, to date current macroeconomic conditions have not materially impacted our programs or our operations. We continue to monitor economic conditions in the U.S. and globally and expect to act proactively where possible to minimize the impact of continued inflation or supply constraints on materials and inventory needed for operations.
Recent Developments
Lomecel-B for Alzheimer’s disease:
| ● | In January 2022, we initiated enrollment of a 48-patient, 4-arm, parallel design, randomized (1:1:1:1) Phase 2a clinical trial of Lomecel-B infusion in patients with mild Alzheimer’s disease. This study is intended to evaluate the safety of single and multiple administrations of Lomecel-B compared to placebo according to the following treatment groups: |
| o | Group 1 (n=12): Placebo infusion (zero cells) on day 0, weeks 4, 8 and 12 |
| o | Group 2 (n=12): Lomecel-B infusion (25 million cells) on day 0, followed by placebo infusions at Weeks 4, 8 and 12 |
| o | Group 3 (n=12): Lomecel-B infusion (25 million cells) on day 0, weeks 4, 8, and 12 |
| o | Group 4 (n=12): Lomecel-B infusion (100 million cells) on day 0, weeks 4, 8, and 12 |
| ● | Other endpoints in the Phase 2a trial include brain volumetry by MRI, biomarkers relevant to inflammation and endothelial/vascular systems, and measures of cognitive function. We have activated 10 of a total of 12 clinical sites to facilitate enrollment, and have now successfully enrolled 12 out of the 48 planned patients. We anticipate completing the full enrollment of this study by the end of 2022. Further details about the trial design can be found on clinicaltrials.gov by entering trial identifier NCT05233774. |
22
Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS):
| ● | The ELPIS II trial (Phase 2a) continues to enroll infants in the 38-patient, 2-arm, parallel design, randomized (1:1), blinded, controlled trial intended to evaluate the safety and efficacy of Lomecel-B injection into the right ventricle of children born with HLHS who are undergoing Stage II reconstructive cardiac surgery. All seven planned clinical sites have now been activated for screening and enrollment, and we are continuing to monitor timelines for the trial as patients continue to be enrolled. |
| ● | A manuscript detailing the full Phase 1 (“ELPIS I”) trial results (the top-line data having been previously announced on September 9, 2021), was released on the pre-print server MedRxiv and will be submitted to a peer-reviewed journal, with acceptance and publication currently anticipated in 2022. |
Lomecel-B for Aging Frailty:
| ● | In collaboration with Dr. Hidenori Arai, president of the National Center for Geriatrics and Gerontology (NCGG) in Japan and primary investigator of the investigator-initiated Japan Aging Frailty Phase 2 trial, we have focused the strategy in Japan toward an approval under Japan’s Act on the Safety of Regenerative Medicine (ASRM). As a result, the protocol endpoints were modified: specifically, the primary objective is to establish the safety of Lomecel-B in this population of Japanese patients. We are pleased that the amended protocol was accepted by the Pharmaceuticals and Medical Devices Agency in Japan (PMDA) on August 8, 2022.. As a result, the trial is currently on track to initiate in the between Q3 and Q4 of 2022. This trial is a 3-arm, parallel design, randomized (1:1:1), placebo-controlled, double-blind single infusion study of two different dose levels of Lomecel-B being conducted by our clinical partners at the NCGG (Nagoya), and Juntendo University Hospital (Tokyo). |
| ● | Top-line results from phase 2 of the Phase 1/2 “HERA” Aging Frailty trial were expected to be disclosed in the first half of 2022 and are being shared now due to the complexities of the data analysis resulting from the recruitment extending across two flu seasons. The HERA Trial was a small multicenter, randomized, placebo-controlled study intended primarily to evaluate safety, and to explore the effect Lomecel-B may have on specific biomarkers of immune system function in older individuals with mild to moderate Aging Frailty who received High Dose (HD) Fluzone®, as well as to evaluate potential effects of Lomecel-B on other signs and symptoms of Aging Frailty. The study met its primary safety endpoint in the randomized placebo-controlled portion evaluating the safety and tolerability of Lomecel-B™ when given one week before with trivalent HD Fluzone® in older adults. The study examined humoral immune responses over two flu seasons using strain-specific hemagglutination inhibition (HAI) antibody titer measurement assay. There was only one strain in common in the vaccine formulation of HD Fluzone® across both study seasons, Influenza B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage). The results showed that HAI antibody responses in the Lomecel-B™ and placebo groups to this Colorado strain were not statistically different. In addition to these experiments, responses to Influenza B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage) strain, which was not a component of HD Fluzone®, were measured. In a finding suggesting Lomecel-B™ general immune responses in older adults, there was an increase in HAI antibody responses to this Phuket strain, representing a possible heterotypic response. The increase in Geometric Mean Titer to the Phuket strain was 91% greater in Lomecel-B™ -treated participants as compared to placebo four weeks after vaccination, when adjusting for baseline measurements in a repeated measures model. Among several assessments of aging frailty, the study found that participants receiving Lomecel-B™ appeared to have an increase in scores at one year in a participant reported outcome (PRO) measure called the PROMIS Physical Function instrument, compared to a decrease in the placebo group. In addition, at 6 months, Lomecel-B™-treated participants had an average change in 6-minute walk test that was 18 meters greater than participants receiving placebo. This is similar to that seen in previous studies such as the Phase 2b trial in Adult Frailty. These results were not powered to be of statistical significance. |
Lomecel-B for Acute Respiratory Distress Syndrome (ARDS) caused by either Covid-19 or Influenza Infection:
| ● | The two-cohort, 70 patient (35 patients per cohort) Phase 1 trial continues to screen subjects at three participating centers in the U.S. Screening and enrollment for this study has been slower than expected due mainly to fewer hospitalizations related to ARDS. It is anticipated that screening will continue through 2022. |
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 ($11.9 million which has been directly awarded to us and which are recognized as revenue when the performance obligations are met) from the NIH, Alzheimer’s Association, and Maryland Stem Cell Research Fund (MSCRF).” |
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| ● | The Bahamas Registry Trial. Participants in The Bahamas Registry Trial pay us a fee to receive Lomecel-B, imported by us 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 expense” below.
Selling and Marketing Expenses
Selling and marketing expenses consist primarily of royalty and license fees associated with our agreements with the University of Miami (“UM”), as well as attending and sponsoring industry, investment, organization and medical conferences and events.
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 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.
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We expect that our research and development expenses will increase 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.
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.
We expect that our general and administrative expenses will increase 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 short-term investments. We expect our interest income to increase due to the current cash and short-term investment 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
As of December 31, 2021, we are treated as a C corporation for federal and state income tax purposes. Prior to February 12, 2021, we were treated as a partnership for federal and state income tax purposes, whereby we passed our earnings and losses through to our members based on the terms of our Operating Agreement. No provision for income taxes has been recorded for the years ended December 31, 2021 and 2020. 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 JUNE 30, 2022 AND 2021
The following table summarizes our results of operations for the three months ended June 30, 2022 and 2021, together with the changes in those items in dollars (in thousands):
| Three Months Ended June 30, | Increase | |||||||||||
| 2022 | 2021 | (Decrease) | ||||||||||
| Revenues | $ | 466 | $ | 489 | $ | (23 | ) | |||||
| Cost of revenues | 306 | 281 | 25 | |||||||||
| Gross profit | 160 | 208 | (48 | ) | ||||||||
| Expenses | ||||||||||||
| General and administrative | 2,427 | 3,257 | (830 | ) | ||||||||
| Research and development | 1,720 | 1,960 | (240 | ) | ||||||||
| Selling and marketing | 234 | 53 | 181 | |||||||||
| Total operating expenses | 4,381 | 5,270 | (889 | ) | ||||||||
| Loss from operations | (4,221 | ) | (5,062 | ) | (841 | ) | ||||||
| Non-operating Lawsuit expense | (1,398 | ) | - | 1,398 | ||||||||
| Forgiveness of Paycheck Protection Program loan | - | - | - | |||||||||
| Interest expense | - | (2 | ) | 2 | ||||||||
| Other (expense) income | (5 | ) | 54 | (59 | ) | |||||||
| Net loss | $ | (5,624 | ) | $ | (5,010 | ) | $ | 614 | ||||
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Revenues, Cost of Revenues and Gross Profit: Revenues for each of the three months ended June 30, 2022 and 2021 were approximately $0.5 million. Grant revenue for the three months ended June 30, 2022 and 2021 was $0.1 million and $0.3 million, respectively. Grant revenue for the three months ended June 30, 2022 was approximately $0.2 million, or 54% lower when compared to the same period in 2021, primarily due to a reduction in grant funds available due in part to the completion of the grant-funded clinical trials. Clinical trial revenue, which comes from the Bahamas Registry Trial, for the three months ended June 30, 2022 and 2021 was $0.3 million and $0.2 million, respectively. Clinical trial revenue for the three months ended June 30, 2022 was approximately $0.1 million, or 59%, higher when compared to the same period in 2021. During the second quarter of 2022, clinical trial revenue increased as a result of an increase in participant demand.
Related cost of revenues was approximately $0.3 million for the three months ended June 30, 2022 and 2021, respectively. Cost of revenues for the three months ended June 30, 2022 was less than $0.1 million, or 9%, higher when compared to the same period in 2021, primarily due to increased cost of revenues for the Bahamas Registry Trial. This resulted in a gross profit of approximately $0.2 million for the three months ended June 30, 2022 and 2021. Gross profit for the three months ended June 20, 2022 was less than $0.1 million, or 23% lower when compared to the same period in 2021.
General and Administrative Expense: General and administrative expenses for the three months ended June 30, 2022 decreased to approximately $2.4 million, compared to $3.2 million for the same period in 2021. The decrease of approximately $0.8 million, or 26%, was primarily related to a decrease of $0.7 million in equity-based compensation expenses allocated to general and administrative expenses. However, expenses related to legal and consulting services increased by $0.2 million in the three months ended June 30, 2022 compared to the same period in 2021.
Research and Development Expenses: Research and development expenses for the three months ended June 30, 2022, decreased to approximately $1.7 million, from approximately $2.0 million for the same period in 2021. The decrease of $0.3 million, or 12%, was primarily due to a decrease in equity-based compensation allocated to research and development expenses, which decreased from $0.8 million for the three months ended June 30, 2021 to $0.1 million for the same period in 2022. However, this was offset by an increase of $0.5 million in research and development expenses that were not reimbursable by grants. 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 June 30, | ||||||||
| 2022 | 2021 | |||||||
| Clinical trial expenses-statistics, monitoring, labs, sites, etc. | $ | 678 | $ | 365 | ||||
| Supplies and costs to manufacture Lomecel-B | 159 | 196 | ||||||
| Employee compensation and benefits | 501 | 328 | ||||||
| Equity-based compensation | 98 | 777 | ||||||
| Depreciation | 173 | 183 | ||||||
| Amortization | 55 | 68 | ||||||
| Travel | 34 | 18 | ||||||
| Other activities | 20 | 25 | ||||||
| $ | 1,720 | $ | 1,960 | |||||
Selling and Marketing Expenses: Selling and marketing expenses for the three months ended June 30, 2022 and 2021 were approximately $0.2 million and $0.1 million, respectively. Selling and marketing expenses consist primarily of investor and public relations expenses.
Non-operating Lawsuit expense: Non-operating Lawsuit expense for the three months ended June 30, 2022 was approximately $1.4 million. This expense was deemed probable and therefore the amount was accrued in this period. Additional detail can be found in Part II, Item 1 “Legal Proceedings” of this Quarterly Report on Form 10-Q. Legal expenses incurred in ordinary business activities are reported within general and administrative expenses.
Other (Expense) Income: Other expense for the three months ended June 30, 2022 was less than $0.1 million. Other expense consisted of an unrealized loss of $0.1 million from short-term investments and interest income of $0.1 million. Other income for the three months ended June 30, 2021 was less than $0.1 million. Other income was primarily the result of $30,000 received in rental payments recorded from a sublease and $22,000 from recorded investment income.
Net Loss: Net loss increased to approximately $5.6 million for the three months ended June 30, 2022, from a net loss of 5.0 million for the same period in 2021. The increase in the net loss of $0.6 million, or 12%, was for reasons outlined above.
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COMPARISON OF THE SIX MONTHS ENDED JUNE 30, 2022 AND 2021
The following table summarizes our results of operations for the six months ended June 30, 2022 and 2021, together with the changes in those items in dollars (in thousands):
| Six Months Ended June 30, | Increase | |||||||||||
| 2022 | 2021 | (Decrease) | ||||||||||
| Revenues | $ | 836 | $ | 865 | $ | (29 | ) | |||||
| Cost of revenues | 376 | 508 | (132 | ) | ||||||||
| Gross profit | 460 | 357 | 103 | |||||||||
| Expenses | ||||||||||||
| General and administrative | 4,407 | 4,963 | (556 | ) | ||||||||
| Research and development | 3,147 | 3,310 | (163 | ) | ||||||||
| Selling and marketing | 521 | 605 | (84 | ) | ||||||||
| Total operating expenses | 8,075 | 8,878 | (803 | ) | ||||||||
| Loss from operations | (7,615 | ) | (8,521 | ) | (906 | ) | ||||||
| Non-operating Lawsuit expense | (1,398 | ) | - | 1,398 | ||||||||
| Forgiveness of Paycheck Protection Program loan | - | 300 | (300 | ) | ||||||||
| Interest expense | (1 | ) | (1 | ) | - | |||||||
| Other (expense) income | (120 | ) | 101 | 221 | ||||||||
| Net loss | $ | (9,134 | ) | $ | (8,121 | ) | $ | 1,013 | ||||
Revenues, Cost of Revenues and Gross Profit: Revenues for each of the six months ended June 30, 2022 and 2021 were approximately $0.8 million and $0.9 million, respectively. Revenues for the six months ended June 30, 2022 were approximately $29,000, or 3% lower when compared to the same period in 2021. Grant revenue for the six months ended June 30, 2022 and 2021 was $0.2 million and $0.5 million, respectively. Grant revenue for the six months ended June 30, 2022 was approximately $0.3 million, or 62% lower when compared to the same period in 2021, primarily due to a reduction in grant funds available due in part to the completion of the grant-funded clinical trials. Clinical trial revenue, which comes from the Bahamas Registry Trial, for the six months ended June 30, 2022 and 2021 was $0.6 million and $0.4 million, respectively. Clinical trial revenue for the six months ended June 30, 2022 was approximately $0.2 million, or 71%, higher when compared to the same period in 2021. During the second quarter of 2022, clinical trial revenue increased as a result of an increase in participant demand.
Related cost of revenues was approximately $0.4 million and $0.5 million for the six months ended June 30, 2022 and 2021, respectively. Cost of revenues for the six months ended June 30, 2022 was $0.1 million, or 26%, less when compared to the same period in 2021, primarily due to decreased cost of revenues for the Bahamas Registry Trial. This resulted in a gross profit of approximately $0.4 million and $0.3 million for the six months ended June 30, 2022 and 2021, respectively. Gross profit for the six months ended June 30, 2022 was $0.1 million or 29% higher when compared to the same period in 2021.
General and Administrative Expense: General and administrative expenses for the six months ended June 30, 2022 decreased to approximately $4.4 million, compared to $5.0 million for the same period in 2021. The decrease of approximately $0.6 million, or 11%, was primarily related to a decrease of $1.1 million in equity-based compensation expenses allocated to general and administrative expenses. However, expenses related to legal and consulting services increased by $0.6 million in the six months ended June 30, 2022 compared to the same period in 2021. In addition, employee benefit expenses increased by $0.3 million, which included expenses related to employee recruitment expenses.
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Research and Development Expenses: Research and development expenses for the six months ended June 30, 2022, decreased to approximately $3.1 million, from approximately $3.3 million for the same period in 2021. The decrease of $0.2 million, or 5%, was primarily due to a decrease in equity-based compensation allocated to research and development expenses, which decreased from $1.2 million for the six months ended June 30, 2021 to $0.2 million for the same period in 2022. However, this was offset by an increase of $1.0 million in research and development expenses that were not reimbursable by grants. Research and development expenses consisted primarily of the following items (less those expenses allocated to the cost of revenues for the grants) (in thousands):
| Six Months Ended June 30, | ||||||||
| 2022 | 2021 | |||||||
| Clinical trial expenses-statistics, monitoring, labs, sites, etc. | $ | 1,119 | $ | 726 | ||||
| Supplies and costs to manufacture Lomecel-B | 246 | 262 | ||||||
| Employee compensation and benefits | 1,010 | 499 | ||||||
| Equity-based compensation | 197 | 1,219 | ||||||
| Depreciation | 317 | 363 | ||||||
| Amortization | 100 | 83 | ||||||
| Travel | 41 | 27 | ||||||
| Other activities | 117 | 130 | ||||||
| $ | 3,147 | $ | 3,309 | |||||
Selling and Marketing Expenses: Selling and marketing expenses for the six months ended June 30, 2022 and 2021 were approximately $0.5 million and $0.6 million, respectively. Selling and marketing expenses consist primarily of investor and public relations expenses.
Non-operating Lawsuit expense: Non-operating Lawsuit expense for the six months ended June 30, 2022 was approximately $1.4 million. This expense was deemed probable and therefore the amount was accrued in this period. Additional detail can be found in Part II, Item 1 “Legal Proceedings” of this Quarterly Report on Form 10-Q. Legal expenses incurred in ordinary business activities are reported within general and administrative expenses.
Forgiveness of Paycheck Protection Program loan: Forgiveness of the Paycheck Protection Program loan for the six months ended June 30, 2022, decreased to approximately $0 million, compared to $0.3 million for the same period in 2021. The decrease of $0.3 million, or 100% was due to the non-recurring nature of the forgiveness of the PPP loan.
Other (Expense) Income: Other expense for the six months ended June 30, 2022 was $0.1 million. Other expense consisted of an unrealized loss of $0.1 million from short-term investments and interest income of $0.1 million. Other income for the six months ended June 30, 2021 was $0.1 million.
Net Loss: Net loss increased to approximately $9.1 million for the six months ended June 30, 2022, from a net loss of 8.1 million for the same period in 2021. The increase in the net loss of $1.0 million, or 12%, was a result of the items outlined above.
Cash Flows
The following table summarizes our sources and uses of cash for the period presented (in thousands):
| Six Months Ended June 30, | ||||||||
| 2022 | 2021 | |||||||
| Net cash used in operating activities | $ | (7,427 | ) | $ | (5,984 | ) | ||
| Net cash provided by investing activities | 2,282 | (4,657 | ) | |||||
| Net cash (used in) provided by financing activities | (289 | ) | 26,658 | |||||
| Change in cash and cash equivalents | $ | (5,434 | ) | $ | 16,017 | |||
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Operating Activities. We have incurred losses since inception. Net cash used in operating activities for the six months ended June 30, 2022 was $7.4 million, consisting primarily of our net loss of $9.1 million as we incurred $1.4 million in non-operating lawsuit expenses, $1.4 million in equity-based compensation expenses and $0.8 million in prepaid insurance expenses. Net cash used in operating activities for the six months ended June 30, 2021 was $6.0 million, consisting primarily of our net loss of $8.1 million as we incurred expenses associated with research activities for our lead product candidates and incurred general and administrative expenses; including $3.5 million of equity-based compensation recorded for RSUs and stock options granted.
Investing Activities. Net cash provided by investing activities for the six months ended June 30, 2022 was $2.3 million consisting primarily of an increase in short-term investments. Net cash used in investing activities for the six months ended June 30, 2021 was $4.7 million, consisting primarily of an increase of $4.5 million in short-term investments.
Financing Activities. Net cash used in financing activities for the six months ended June 30, 2022 was $0.3 million for the payment of taxes upon vesting of RSUs. Net cash provided by financing activities for the six months ended June 30, 2021 was $26.7 million consisting primarily of $26.1 million in net proceeds received from our IPO.
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, private placement equity financings, grant awards, and fees generated from the Bahamas Registry Trial and contract manufacturing services. Since we were formed, we have raised approximately $77.2 million in gross proceeds from the issuance of equity. As of June 30, 2022, the Company had cash, and cash equivalents of $20.2 million, short-term investments of $6.8 million and working capital of approximately $24.6 million.
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Grant Awards
From inception through June 30, 2022, 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 June 30, 2022, and December 31, 2021, the amount of unused grant funds that were available for us to draw was approximately $0.6 million and $0.8 million, respectively.
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.
Funding Requirements
Our operating costs will continue to increase substantially 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 through the first half 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.
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; |
| ● | the progress, costs and results of additional research and preclinical studies in other research programs we initiate in the future; |
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| ● | 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. |
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, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. 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.
Contractual Obligations and Commitments
As of June 30, 2022, we have $3.4 million in operating lease obligations and in contract research organization payment 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 Policies and Use of Estimates
Our management’s discussion and analysis of financial condition, results of operations and liquidity are based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the U.S. (“U.S. GAAP”). The preparation of our financial statements and related disclosures requires us to make estimates, judgements and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may materially differ from these estimates under different assumptions or conditions. On an on-going basis, we review our estimates to ensure that they appropriately reflect changes in our business or new information as it becomes available.
While our significant accounting policies are described in more detail in the notes to our financial statements included in the 2021 10-K, we believe that the following accounting policies are those most critical due to the judgments and estimates used in the preparation of our financial statements.
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Intangible assets. Intangible assets include payments on license agreements with our co-founder and CSO and UM and legal costs incurred related to patents and trademarks. License agreements have been recorded at the value of cash consideration and/or estimated value of membership units transferred to the respective parties when acquired. Payments on license agreements are amortized using the straight-line method over the estimated useful life of 20 years. Patents are amortized over their estimated useful life, once issued. We consider trademarks to have an indefinite useful life and evaluate them for impairment on an annual basis. Amortization expense is recorded in the research and development line of the Statement of Operations as the assets are primarily related to our clinical programs.
Impairment of Long-Lived Assets. We evaluate 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 on the statements of operations. Management determined that there was no impairment of long-lived assets during the three months ended June 30, 2022 and 2021.
Deferred revenue. The unearned portion of advanced grant funds and prepayments for Clinical trial revenue, which will be recognized as revenue when the Company meets the respective performance obligations, has been presented as deferred revenue in the accompanying balance sheets. For the six months ended June 30, 2022 and 2021, the Company recognized $0.1 million and $0, respectively of funds that were previously classified as deferred revenue ($0.1 million and $0.4 million, respectively for the three months ended June 30, 2022 and 2021, respectively).
Revenue recognition. Effective January 1, 2018, we adopted ASC Topic 606, Revenue from Contracts with Customers, which establishes a single and comprehensive framework on how much revenue is to be recognized, and when. The core principle is that a vendor should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the vendor expects to be entitled in exchange for those goods or services. Revenue will be recognized by a vendor when control over the goods or services is transferred to the customer.
We recognize revenue when performance obligations related to respective revenue streams are met. For Grant Revenue, we consider the performance obligation met when the grant related expenses are incurred, or supplies and materials are received. For clinical trial revenue, we consider the performance obligation met when the participant has received the therapy. For Contract Manufacturing Revenue, we consider the performance obligation met when the contractual obligation and/or statement of work has been satisfied.
Cost of revenues. We record cost of revenues based on expenses directly related to revenue. For grant revenue, we record allocated expenses for research and development costs to a grant as a cost of revenues. Expenses directly related to clinical trial revenue are allocated and accrued as incurred. These expenses are similar to those described in the “Research and development expense” section of the Notes to the Condensed Financial Statements in this report.
Research and development expense. Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development. 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 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.
Equity-based compensation. We account for equity-based compensation expense by the measurement and recognition of compensation expense for unit-based awards based on estimated fair values on the date of grant. The fair value of incentive awards are estimated at the date of the grant using a 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 unit price volatility, the expected life of the 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 for the incentive awards.
The Company estimates the fair value of its units by using the Black-Scholes option-pricing model. Volatility is a measure of the amount by which a financial variable, such as a unit 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 publicly traded companies that are similar 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 option was granted. The expected life is the period of time that the options granted are expected to remain outstanding. Incentive awards have a maximum term of ten years. The Company has insufficient historical data to utilize in determining its expected life assumptions and, therefore, uses the simplified method for determining expected life.
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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 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 has 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 audited 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 2021 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 June 30, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. We are continuously monitoring and assessing the impact of COVID-19 on our internal controls to minimize any impact it may have on their design and operating effectiveness.
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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 previously disclosed in our 10-Q filed with the SEC on November 12, 2021, a securities class action lawsuit was filed on September 13, 2021 against the Company and certain of our directors and officers in the United States District Court for the Southern District of Florida. On April 26, 2022, plaintiff filed an amended complaint with related allegations. The complaint, as amended, alleges that there were materially false and misleading statements made (or omissions of material information) in the Company’s initial public offering documents and in other disclosures during the period from our initial public offering on February 12, 2021, through August 12, 2021, in violation of federal securities laws. The complaint seeks unspecified damages on behalf of a purported class of purchasers of our common stock during said period. On July 12, 2022, all parties preliminarily agreed to settle the action for approximately $1.4 million, which amount was accrued as of June 30, 2022 and included in accrued expenses on the accompanying unaudited June 30, 2022 balance sheet. The parties are in the process of documenting the settlement and full release, which will be subject to Court approval.
Item 1A. Risk Factors.
There have been no material changes to the risk factors affecting the Company from those disclosed in the 2021 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
ISSUER PURCHASES OF EQUITY SECURITIES
| Period | Total | Average Price Paid per Share (or Unit) | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs | Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs | ||||||||||||
| April 2022 | 6,627 | $ | 15.46 | |||||||||||||
| May 2022 | - | - | ||||||||||||||
| June 2022 | 6,254 | $ | 8.73 | |||||||||||||
| Total | 12,881 | $ | 12.19 | |||||||||||||
| (a) | Includes shares withheld from employees to satisfy minimum tax withholding obligations associated with the vesting of restricted stock units during the period. |
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
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Item 6. Exhibits.
| Exhibit No. | Description | |
| 31.1 | Certification of principal executive officer, pursuant to SEC Rules 13a-14(a) and 15d-14(a) adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| 31.2 | Certification of principal financial officer, pursuant to SEC Rules 13a-14(a) and 15d-14(a) adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| 32.1 | Certification of principal executive officer, and principal financial officer, pursuant to 18 U.S.C. Section 1350, adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
| 101.INS | Inline XBRL Instance Document | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
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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: August 12, 2022 | /s/ K. Christopher Min |
| Dr. K. Christopher Min | |
| Interim Chief Executive Officer and Chief Medical Officer | |
| (principal executive officer) |
| Date: August 12, 2022 | /s/ James Clavijo |
| James Clavijo | |
| Chief Financial Officer | |
| (principal financial and accounting officer) |
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Exhibit 31.1
Rule 13a-14(a)/15(d)-14(a) Certifications
I, K. Christopher Min, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Longeveron Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant ‘s internal control over financial reporting. |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| /s/ K. Christopher Min | |
| K. Christopher Min | |
| Interim Chief Executive Officer and Chief Medical Officer | |
| Date: August 12, 2022 |
Exhibit 31.2
Rule 13a-14(a)/15(d)-14(a) Certifications
I, James Clavijo, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Longeveron Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant ‘s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| /s/ James Clavijo | |
| James Clavijo | |
| Chief Financial Officer | |
| Date: August 12, 2022 |
Exhibit 32.1
SECTION 1350 CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934, as amended, and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, K. Christopher Min, Interim Chief Executive Officer (principal executive officer) and Chief Medical Officer of Longeveron Inc. (the “Company”), and James Clavijo, the Chief Financial Officer (principal financial officer) of the Company, each hereby certifies that, to his knowledge on the date hereof:
(a) The Quarterly Report on Form 10-Q of the Company for the period ended June 30, 2022 filed on the date hereof with the Securities and Exchange Commission (the “Quarterly Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(b) The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the period covered by the Quarterly Report.
This certification shall not be deemed to be filed with the Securities and Exchange Commission and shall not be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Quarterly Report), irrespective of any general incorporation language contained in such filing. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained and furnished to the Securities and Exchange Commission or its staff upon request.
| /s/ K. Christopher Min | |
| K. Christopher Min | |
K.
Christopher Min August 12, 2022 |
| /s/ James Clavijo | |
James
Clavijo | |
| August 12, 2022 |