Notes to Unaudited Condensed Financial Statements
Three Month Periods Ended March 31, 2023 and 2022
1. Nature of Business, Basis of Presentation, and Liquidity
Nature of business:
Longeveron, LLC was formed as a Delaware limited
liability company on October 9, 2014, and was authorized to transact business in Florida on December 15, 2014. On February 12, 2021, Longeveron,
LLC converted its corporate form (the “Corporate Conversion”) from a Delaware limited liability company (Longeveron, LLC)
to a Delaware corporation, Longeveron Inc. (the “Company,” “Longeveron” or “we,” “us,”
or “our”). The Company is a clinical stage biotechnology company developing cellular therapies for specific aging-related
and life-threatening conditions. The Company operates out of its leased facilities in Miami, Florida.
The Company’s product candidates are currently
in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate
protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government
regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts
are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates
in an environment of rapid technological change and substantial competition from, among others, existing pharmaceutical and biotechnology
companies. In addition, the Company is dependent upon the services of its employees, partners and consultants.
The accompanying
interim condensed balance sheet as of March 31, 2023, and the condensed statements of operations, statement of comprehensive loss, stockholders’
equity, and cash flows for the three months ended March 31, 2023 and 2022, are unaudited. The unaudited condensed financial statements
have been prepared according to the rules and regulations of the Securities and Exchange Commission (“SEC”) and, therefore,
certain information and disclosures normally included in financial statements prepared in accordance with accounting principles generally
accepted in the United States of America (“US GAAP”) have been omitted. In the opinion of management, the accompanying unaudited
condensed financial statements for the periods presented reflect all adjustments which are normal and recurring, and necessary to fairly
state the financial position, results of operations, and cash flows of the Company. These unaudited condensed financial statements
and notes should be read in conjunction with the audited financial statements and notes thereto in the Company’s 2022 Annual Report
on Form 10-K filed with the Securities & Exchange Commission (SEC) on March 14, 2023.
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 condensed financial statements do not include adjustments that might result from the outcome of these
uncertainties.
The Company has incurred recurring losses from
operations since its inception, including a net loss of $4.6 million and $3.5 million for the three months ended March 31, 2023 and 2022,
respectively. In addition, as of March 31, 2023, the Company had an accumulated deficit of $67.4 million. The Company expects to continue
to generate operating losses for the foreseeable future.
As of March 31, 2023, the Company had cash, and
cash equivalents of $5.0 million and marketable securities of $8.7 million. The Company has prepared a cash flow forecast which indicates
that it does not have sufficient cash to meet its minimum expenditure commitments for one year from the date these condensed financial
statements are available to be issued and therefore needs to raise additional funds to continue as a going concern. As a result, there
is substantial doubt about the Company’s ability to continue as a going concern. To address the future funding requirements, management
has undertaken the following initiatives:
| ● | the Company may seek additional capital in the private and/or
public equity markets, to continue its operations, respond to competitive pressures, develop new products and services, and to support
new strategic partnerships. The Company is evaluating additional equity/debt financing opportunities on an ongoing basis and may execute
them when appropriate. However, there can be no assurances that the Company can consummate such a transaction or consummate a transaction
at favorable pricing; |
| ● | the Company will attempt to use equity instruments to provide
a portion of the compensation due to vendors and collaboration partners; |
| ● | the Company plans to pursue potential partnerships for pipeline
programs, however, there can be no assurances that it can consummate such transactions; |
| ● | the Company will continue to support its Bahamas Registry
to generate revenue; and |
| ● | since 2016 our clinical programs have received over $16.0
million in competitive extramural grant awards ($11.5 million which has been directly awarded to us and which are recognized as revenue
when the performance obligations are met) from the National Institutes of Health (NIH), Alzheimer’s Association, and Maryland Stem
Cell Research Fund (MSCRF), and the Company plans to submit additional contract and grant applications for further support of its programs
with various funding agencies. |
The Company’s condensed financial statements
do not include any adjustments to the assets’ carrying amount, to the expenses presented and to the reclassification of the condensed
balance sheets items that could be necessary should the Company be unable to continue its operations.
2. Summary
of Significant Accounting Policies
Basis of presentation:
The condensed financial statements of the Company
were prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”).
Certain reclassifications have been made to prior year condensed
financial statements to conform to classifications used in the current year. These reclassifications had no impact on net loss,
shareholders’ equity or cash flows as previously reported.
Use of estimates:
The presentation of condensed financial statements
in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could differ from those estimates.
Accounting Standard Updates
A variety of proposed or otherwise potential accounting
standards are currently under consideration by standard-setting organizations and certain regulatory agencies. Because of the tentative
and preliminary nature of such proposed standards, management has not yet determined the effect, if any, that the implementation of such
proposed standards would have on the Company’s condensed financial statements.
In June 2016, the FASB issued ASU 2016-13, Financial
Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments. The standard requires that credit losses be reported
using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related
to credit risks. For available-for-sale debt securities with unrealized losses, these standards now require allowances to be recorded
instead of reducing the amortized cost of the investment. These standards limit the amount of credit losses to be recognized for available-for-sale
debt securities to the amount by which carrying value exceeds fair value and requires the reversal of previously recognized credit losses
if fair value increases. The adoption of the standard as of January 1, 2023 did not have a material impact on the Company’s condensed
financial statements; however, the Company did record a net unrealized loss in the statement of comprehensive loss for the three month
period ended March 31, 2023.
Cash and cash equivalents:
The Company considers cash to consist of cash
on hand and temporary investments having an original maturity of 90 days or less that are readily convertible into cash.
Marketable securities:
Marketable securities at March 31, 2023 and December
31, 2022 consisted of marketable fixed income securities, primarily corporate bonds, as well as U.S. Government and agency obligations
which are categorized as available for sale securities and are thus marked to market and stated at fair value in accordance with ASC 820
Fair Value Measurement. These investments are considered Level 1 and Level 2 investments within the ASC 820 fair
value hierarchy. The fair value of Level 1 investments, including cash equivalents, money funds and U.S. government securities, are
substantially based on quoted market prices. The fair value of corporate bonds is determined using standard market valuation methodologies,
including discounted cash flows, matrix pricing and/or other similar techniques. The inputs to these valuation techniques include
but are not limited to market interest rates, credit rating of the issuer or counterparty, industry sector of the issuer, coupon rate,
call provisions, maturity, estimated duration and assumptions regarding liquidity and estimated future cash flows. In addition to
bond characteristics, the valuation methodologies incorporate market data, such as actual trades completed, bids and actual dealer quotes,
where such information is available. Accordingly, the estimated fair values are based on available market information and judgments about
financial instruments categorized within Level 1 and Level 2 of the fair value hierarchy. Interest and dividends are recorded when
earned. Realized gains and losses on investments are determined by specific identification and are recognized as incurred in the
condensed statement of operations. Changes in net unrealized gains and losses are reported in other comprehensive loss and represent
the change in the fair value of investment holdings during the reporting period. Changes in net unrealized losses were $0.3 million
and $0 for the three months ended March 31, 2023 and 2022, respectively.
Accounts and grants receivable:
Accounts and grants receivable include amounts
due from customers, granting institutions and others. The amounts as of March 31, 2023, and December 31, 2022 are certain to be collected,
and no amount has been recognized for doubtful accounts. In addition, for the Clinical trial revenue, most participants pay in advance
of treatment. Advanced grant funds and prepayments for the Clinical trial revenue are recorded to deferred revenue.
Accounts and grants receivable by source, as of
(in thousands):
| |
March 31,
2023 | | |
December 31,
2022 | |
National Institutes of Health – Grant | |
$ | 96 | | |
$ | 218 | |
Total | |
$ | 96 | | |
$ | 218 | |
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 condensed statements of operations as the assets are primarily related to the Company’s
clinical programs.
Intangible assets:
Intangible assets include payments on license
agreements with the Company’s co-founder and chief scientific officer (“CSO”) and the University of Miami (“UM”)
(see Note 9) and legal costs incurred related to patents and trademarks. License agreements have been recorded at the value of cash consideration,
common stock and membership units transferred to the respective parties when acquired.
Payments for license agreements are amortized
using the straight-line method over the estimated term of the agreements, which range from 5-20 years. Patents are amortized over their
estimated useful life, once issued. The Company considers trademarks to have an indefinite useful life and evaluates them for impairment
on an annual basis. Amortization expense is recorded in the research and development line of the condensed statements of operations as
the assets are primarily related to the Company’s clinical programs.
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 condensed statements of operations. Upon evaluation, management determined that there was no impairment
of long-lived assets during the three months ended March 31, 2023 and 2022.
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 condensed balance sheets. For the three months ended March 31, 2023 and 2022,
the Company recognized $0 and $19,000 of funds that were previously classified as deferred revenue ($0.1 million and $0 million, respectively
for the three months ended March 31, 2023 and 2022, respectively). Due to the MSCRF – Technology Development Corporation (TEDCO)
– grant Accute Respiratory Distress Syndrome (ARDS) program being discontinued, the $0.4 million recorded as deferred revenue will
be reversed when the funds are returned to MSCRF – TEDCO.
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.
Revenue by source (in thousands):
| |
Three months ended
March 31, | |
| |
2023 | | |
2022 | |
NIH - grant | |
$ | 41 | | |
$ | 41 | |
Clinical trial revenue | |
| 238 | | |
| 310 | |
MSCRF – TEDCO - grant | |
| - | | |
| 19 | |
Total | |
$ | 279 | | |
$ | 370 | |
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, marketable securities and accounts and grants receivable.
Cash and cash equivalents are held in U.S. financial institutions. At times, the Company may maintain balances in excess of the federally
insured amounts.
Income taxes:
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 condensed 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 $0 for the three months ended March 31, 2023 and
2022 due to net operating losses. The Company has not recorded any tax benefit for the net operating losses incurred due to the offset
created by the Company’s valuation allowance.
The Company recognizes the tax benefits from uncertain
tax positions that the Company has taken or expects to take on a tax return. In the unlikely event an uncertain tax position exists in
which the Company could incur income taxes, the Company would evaluate whether there is a probability that the uncertain tax position
taken would be sustained upon examination by a taxing authority. Reserves for uncertain tax positions would then be recorded if the Company
determined it is probable that either a position would not be sustained upon examination, or a payment would have to be made to a taxing
authority and the amount was reasonably estimable. As of March 31, 2023 and December 31, 2022, 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.
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 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.
3. Marketable
securities
The following is summary of Marketable securities
that the Company measures at fair value:
| |
Fair Value at March 31, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
U.S. Treasury obligations | |
$ | 98,133 | | |
$ | - | | |
$ | - | | |
$ | 98,133 | |
U.S. government agencies | |
| - | | |
| 1,064,992 | | |
| - | | |
| 1,064,992 | |
Corporate and foreign bonds | |
| - | | |
| 7,530,053 | | |
| - | | |
| 7,530,053 | |
Money market funds(1) | |
| 1,190,450 | | |
| - | | |
| - | | |
| 1,190,450 | |
Accrued income | |
| 66,862 | | |
| - | | |
| - | | |
| 66,862 | |
Total Marketable securities | |
$ | 1,355,445 | | |
$ | 8,595,045 | | |
$ | - | | |
$ | 9,950,490 | |
(1) | Money market funds are included in cash and cash equivalents
in the condensed balance sheet. |
| |
Fair Value at December 31, 2022 | |
| |
| Level 1 | | |
| Level 2 | | |
| Level 3 | | |
| Total | |
| |
| | | |
| | | |
| | | |
| | |
U.S. Treasury obligations | |
$ | 96,981 | | |
$ | - | | |
$ | - | | |
$ | 96,981 | |
U.S. government agencies | |
| - | | |
| 1,250,003 | | |
| - | | |
| 1,250,003 | |
Corporate and foreign bonds | |
| - | | |
| 7,807,655 | | |
| - | | |
| 7,807,655 | |
Money market funds(1) | |
| 607,263 | | |
| - | | |
| - | | |
| 607,263 | |
Accrued income | |
| 64,815 | | |
| - | | |
| - | | |
| 64,815 | |
Total Marketable securities | |
$ | 769,059 | | |
$ | 9,057,658 | | |
$ | - | | |
$ | 9,826,717 | |
(2) | Money market funds are included in cash and cash equivalents
in the condensed balance sheet. |
As of March 31, 2023, and December 31, 2022, the
Company reported accrued interest receivable related to Marketable securities of $66,862 and $64,815, respectively. These amounts are
recorded in other assets on the condensed balance sheets and are not included in the carrying value of the Marketable securities.
4. Property
and equipment, net
Major components of property and equipment are as follows (in thousands):
| |
Useful Lives | |
March 31,
2023 | | |
December 31,
2022 | |
Leasehold improvements | |
10 years | |
$ | 4,328 | | |
$ | 4,328 | |
Furniture/Lab equipment | |
7 years | |
| 2,303 | | |
| 2,264 | |
Computer equipment | |
5 years | |
| 49 | | |
| 46 | |
Software/Website | |
3 years | |
| 38 | | |
| 38 | |
Total property and equipment | |
| |
| 6,718 | | |
| 6,676 | |
Less accumulated depreciation and amortization | |
| |
| 3,908 | | |
| 3,727 | |
Property and equipment, net | |
| |
$ | 2,810 | | |
$ | 2,949 | |
Depreciation and amortization expense amounted
to approximately $0.2 million and $0.1 million for the three-month periods ended March 31, 2023 and 2022.
5. Intangible
assets, net
Major components of intangible assets as of March
31, 2023, are as follows (in thousands):
| |
Useful Lives | |
Cost | | |
Accumulated
Amortization | | |
Total | |
License agreements | |
20 years | |
$ | 2,044 | | |
$ | (742 | ) | |
$ | 1,302 | |
Patent Costs | |
| |
| 951 | | |
| - | | |
| 951 | |
Trademark costs | |
| |
| 172 | | |
| - | | |
| 172 | |
Total | |
| |
$ | 3,167 | | |
$ | (742 | ) | |
$ | 2,425 | |
Major components of intangible assets as of December
31, 2022, are as follows:
| |
Useful Lives | |
Cost | | |
Accumulated
Amortization | | |
Total | |
License agreements | |
20 years | |
$ | 2,043 | | |
$ | (685 | ) | |
$ | 1,358 | |
Patent Costs | |
| |
| 887 | | |
| - | | |
| 887 | |
Trademark costs | |
| |
| 164 | | |
| - | | |
| 164 | |
Total | |
| |
$ | 3,094 | | |
$ | (685 | ) | |
$ | 2,409 | |
Amortization expense related to intangible assets
amounted to approximately $0.1 million for each of the three-month periods ended March 31, 2023 and 2022.
Future amortization
expense for intangible assets as of March 31, 2023, is approximately as follows (in thousands):
Year Ending December 31, | |
Amount | |
2023 (remaining nine months) | |
$ | 168 | |
2024 | |
| 224 | |
2025 | |
| 224 | |
2026 | |
| 224 | |
2027 | |
| 224 | |
Thereafter | |
| 238 | |
Total | |
$ | 1,302 | |
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 March 31, 2023, the ROU asset and lease liability were approximately $1.5 million and $2.5 million, respectively.
As of December 31, 2022, the ROU asset and lease liability were approximately $1.5 million and $2.6 million, respectively.
Future minimum
payments under the operating leases as of March 31, 2023, are as follows (in thousands):
Year Ending December 31, | |
Amount | |
2023 (remaining nine months) | |
$ | 518 | |
2024 | |
| 702 | |
2025 | |
| 718 | |
2026 | |
| 735 | |
2027 | |
| 185 | |
Total | |
| 2,858 | |
Less: Interest | |
| 392 | |
Present Value of Lease Liability | |
$ | 2,466 | |
During each of the three months ended March 31,
2023 and 2022, the Company incurred approximately $0.3 million of total lease costs, that are included in the general and administrative
expenses in the condensed statements of operations.
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 one-year renewal periods, and $10,000
in monthly payments. The sublease was terminated in the second quarter of 2022. For the three months ended March 31, 2023, $0 was recognized
as sublease income as compared to $30,000 for the same period in 2022. For the year ended December 31, 2022, $27,000 was recognized as
sublease income, due to the Company receiving $17,000 of equipment and $10,000 of security deposit forfeited.
7. Stockholders’ Equity
Class A Common Stock
On January 3, 2023, a total of 20,161 RSUs granted
in connection with the Company’s IPO vested, of which 18,005 were held by Company employees. The Company is required to make mandatory
tax withholding for the payment and satisfaction of income tax, social security tax, payroll tax, or payment on account of other tax related
to withholding obligations that arise by reason of vesting of an RSU. The taxable income is calculated by multiplying the number of vested
RSUs for each individual by the closing share price as of the vesting date ($3.37 on January 3, 2023) and a tax liability is calculated
based on each individual’s tax bracket. As a result, on January 3, 2023, the Company recorded a tax liability of $15,000 for the
employees and a corresponding tax liability for the Company of $2,000. In total, the Company paid $17,000 for employee and employer taxes
that resulted from the vesting of RSUs. In order to cover the employee tax liability, the Company withheld 4,431 shares of Class A Common
Stock owned by the employees upon vesting. The shares withheld are available for reissuance pursuant to the 2021 Incentive Plan.
On November 16, 2022, the Company accounted for
but had not issued 48,140 RSUs convertible to unregistered shares of Class A Common Stock, with an aggregate value of $207,000 as payment
for accrued expenses under a consulting agreement with Dr. Hare.
On October 3, 2022, a total of 20,157 RSUs granted
in connection with the Company’s IPO vested, of which 18,001 were held by Company employees. Based on the closing price of $3.75
on October 3, 2022, the Company recorded a tax liability of $16,000 for the employees and a corresponding tax liability for the Company
of $2,000. In total, the Company paid $18,000 for employee and employer taxes that resulted from the vesting of RSUs. In order to cover
the employee tax liability, the Company withheld 4,204 shares of Class A Common Stock owned by the Company’s employees upon vesting.
The shares withheld are available for reissuance pursuant to the 2021 Incentive Plan.
On July 1, 2022, a total of 20,158 RSUs granted
in connection with the Company’s IPO vested, of which 18,002 were held by Company employees. Based on the closing price of $5.94
on July 1, 2022, the Company recorded a tax liability of $26,000 for the employees and a corresponding tax liability for the Company of
$2,000. In total, the Company paid $28,000 for employee and employer taxes that resulted from the vesting of RSUs. In order to cover the
employee tax liability, the Company withheld 4,726 shares of Class A Common Stock owned by the Company’s employees upon vesting.
The shares withheld are available for reissuance pursuant to the 2021 Incentive Plan.
On June 22, 2022, a total of 27,854 RSUs were
granted to the Company’s former Chief Executive Officer, Geoff Green, in exchange for $170,000 of compensation, as agreed upon in
connection with his separation.
On June 3, 2022, a total of 26,666 RSUs that previously
had been granted to our Chief Financial Officer and General Counsel vested. RSUs are taxable upon vesting based on the market value on
the date of vesting. Based on a closing price of $8.73 on June 3, 2022, the Company recorded a tax liability of $55,000 for the employees
and a corresponding tax liability for the Company of $2,000. In total, the Company paid $57,000 for employee and employer taxes resulting
from the vesting of RSUs. In order to cover the employee tax liability, the Company withheld 6,254 shares of Class A Common Stock owned
by the employees upon vesting. The shares withheld are available for reissuance pursuant to the 2021 Incentive Plan.
On April 4, 2022, a total of 1,167 RSUs that previously
had been granted to our Chief Medical Officer vested. Based on the closing price of $12.85 on April 3, 2022, the Company recorded a tax
liability of $5,000 for the employee and a corresponding tax liability for the Company of $1,000. In total, the Company paid $6,000 for
employee and employer taxes that resulted from the vesting of RSUs. In order to cover the employee tax liability, the Company withheld
357 shares of Class A Common Stock owned by the Chief Medical Officer upon vesting. The shares withheld are available for reissuance pursuant
to the 2021 Incentive Plan.
On April 1, 2022, a total of 31,016 RSUs granted
in connection with the Company’s IPO vested, of which 26,360 were held by Company employees. Based on the closing price of $15.61
on April 1, 2022, the Company recorded a tax liability of $105,000 for the employees and a corresponding tax liability for the Company
of $14,000. In total, the Company paid $119,000 for employee and employer taxes that resulted from the vesting of RSUs. In order to cover
the employee tax liability, the Company withheld 6,222 shares of Class A Common Stock owned by the Company’s employees upon vesting.
The shares withheld are available for reissuance pursuant to the 2021 Incentive Plan.
On April 1, 2022, a total of 2,500 RSUs that were
previously granted to a member of the Company’s Board of Directors vested.
On February 12, 2022, a total of 8,750 RSUs that
were previously granted to members of the Company’s Board of Directors upon the completion of the IPO vested.
On January 3, 2022, a total of 35,246 RSUs granted
in connection with the Company’s IPO vested, of which 29,614 were held by Company employees. Based on the closing price of $12.09
on January 3, 2022, the Company recorded a tax liability of $92,000 for the employees and a corresponding tax liability for the Company
of $14,000. In total, the Company paid $106,000 for employee and employer taxes that resulted from the vesting of RSUs. In order to cover
the employee tax liability, the Company withheld 10,627 shares of Class A Common Stock owned by the Company’s employees upon vesting.
The shares withheld are available for reissuance pursuant to the 2021 Incentive Plan.
Class B Common Stock
In connection with the Corporate Conversion, 2,000,000
outstanding Series A and B units were converted into 15,702,834 shares of our unregistered Class B Common Stock.
Holders of Class A Common Stock generally have
rights identical to holders of Class B Common Stock, except that holders of Class A Common Stock are entitled to one vote per
share and holders of Class B Common Stock are entitled to five (5) votes per share. The holders of Class B Common Stock may convert each
share of Class B Common Stock into one share of Class A Common Stock at any time at the holder’s option. Class B Common Stock is
not publicly tradable.
During the three months ended March 31, 2023,
shareholders exchanged 20,000 shares of Class B Common Stock for 20,000 shares of Class A Common Stock. During the year ended December
31, 2022, shareholders exchanged 811,749 shares of Class B Common Stock for 811,749 shares of Class A Common Stock.
Warrants
As part of the IPO, the underwriter received
warrants to purchase 106,400 shares of Class A Common Stock. The warrants are exercisable at any time and from time to time, in whole
or in part, during the four and a half-year period commencing August 12, 2021, at a price of $12.00 per share and the fair value of warrants
was approximately $0.5 million. During 2021, the underwriters assigned 95,760 of the warrants to its employees. As of December 31, 2021,
51,061 warrants have been exercised for Class A Common Stock shares at an exercise price of $12.00 for $612,732.
As part of the 2021 PIPE Offering, the Company
issued 1,169,288 warrants to investors to purchase up to a number of shares of Class A Common Stock equal to the number of shares of Class
A Common Stock purchased by such investor in the offering, at an exercise price of $17.50 per share. The purchaser warrants are immediately
exercisable, expire five years from the date of issuance and have certain downward pricing adjustment mechanisms, subject to a floor,
as set forth in greater detail in the purchase warrants. In addition, the Company granted the underwriters warrants, under similar terms,
to purchase 46,722 shares of Class A Common Stock, at an exercise price of $17.50 per share.
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 March 1, 2023, the company granted Mr. Hashad
a signing bonus of 50,000 Restricted Stock Units, which shall vest in quarterly installments on each of April 1, 2023, July 1, 2023, September
1, 2023, and December 31, 2023. Mr. Hashad will also be eligible to receive annual long-term equity incentive awards through 2026 consisting
of 50,000 shares of time-based vesting stock options and up to 125,000 of performance share units, in accordance with the terms of the
Longeveron 2021 Incentive Award Plan.
On November 16,
2022, the Company accounted for but had not issued 48,140 RSUs
convertible to unregistered shares of Class A Common Stock, with an aggregate value of $207,000 as
payment for accrued expenses under a consulting agreement with Dr. Hare.
On September 6, 2022, the Company granted Mr.
Bailey received an equity incentive award of 20,000 RSUs. The RSUs will vest 25% upon the first-year anniversary of his first day of employment
with Longeveron, with 25% vesting thereafter on the second, third and fourth anniversaries of his employment. In each case, the vesting
of the equity awards will be subject to Mr. Bailey’s continued service through the applicable vesting dates. RSUs shall be expensed
on a quarterly basis at the rate of $5,838 for the quarterly vesting amount of 1,250 RSUs, with a price per share of $4.67 (the closing
price of the Company’s stock on September 6, 2022).
On June 22, 2022, the Company granted $170,000
of separation compensation to Mr. Green (Mr. Green resigned as CEO effective June 1, 2022), which were converted into 27,854 RSUs. The
RSU were issued based on the three-day average of the fair market value prior to the time of grant, June 22, 2022, of $6.10.
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 40,000 RSUs each that vested one-third at the grant
date, with the remaining two thirds vesting on each anniversary of the grant date. The RSU were issued based on a fair market value at
the time of grant, June 3, 2022, of $8.73.
On April 4, 2022, the Company appointed K. Chris
Min, M.D., Ph.D. as its Chief Medical Officer. Dr. Min’s employment agreement provides annual base salary of $350,000, and he will
be eligible to receive a performance bonus equal to 30% of his base salary, prorated for his first year of employment. Dr. Min received
a $60,000 signing bonus, with 50% of this amount paid in RSUs and 50% in stock options. Dr. Min also received two equity incentive awards:
150,000 RSUs and a stock option award exercisable for 50,000 shares. Each award will vest 25% upon the first-year anniversary of his first
day of employment with Longeveron, with 25% vesting thereafter on the second, third and fourth anniversaries of his employment. In each
case, the vesting of the equity awards will be subject to Dr. Min’s continued service through the applicable vesting dates. RSUs
shall be expensed on a quarterly basis at the rate of $0.1 million for the quarterly vesting amount of 9,375 RSUs, with a price per share
of $12.85 (the closing price of the Company’s stock on April 4, 2022). Stock options shall be expensed based upon a Black-Scholes
calculation, the price per share to be expensed was $11.34 and a total cost of $0.6 million would be expensed ratably over 48 months.
As of March 31, 2023, and December 31, 2022, the
Company had 356,297 and 329,746, respectively RSUs outstanding (unvested).
RSU activity for the three months ended March
31, 2023, was as follows:
| |
Number of
RSUs | |
Outstanding (unvested) at December 31, 2022 | |
| 329,746 | |
RSU granted | |
| 50,000 | |
RSUs vested | |
| (23,149 | ) |
RSU expired/forfeited | |
| - | |
Outstanding (unvested) at March 31, 2023 | |
| 356,597 | |
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 5% of the outstanding common stock shares.
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 0%; an expected life of 10 years;
volatility of 95%; and risk-free interest rate based on the grant date ranging from of 1.23% to 3.68%. Each option grant
made during 2023 and 2022, will be expensed ratably over the option vesting periods, which approximates the service period.
As of March 31, 2023 and December 31, 2022, the
Company has recorded issued and outstanding options to purchase a total of 470,191 shares of Class A Common Stock pursuant to the 2021
Incentive Plan, at a weighted average exercise price of $7.07 per share.
For the three months ended March 31, 2023:
| |
Number of
Stock Options | |
Stock options vested (based on ratable vesting) | |
| 194,120 | |
Stock options unvested | |
| 276,071 | |
Total stock options outstanding at March 31, 2023 | |
| 470,191 | |
For the year ended December 31, 2022:
| |
Number of
Stock Options | |
Stock options vested (based on ratable vesting) | |
| 151,258 | |
Stock options unvested | |
| 318,933 | |
Total stock options outstanding at December 31, 2022 | |
| 470,191 | |
Stock Option activity for the three months ended
March 31, 2023, was as follows:
| |
Number
of
Stock Options | | |
Weighted
Average
Exercise Price | |
Outstanding at December 31, 2022 | |
| 470,191 | | |
$ | 7.07 | |
Options granted | |
| - | | |
| - | |
Options exercised | |
| - | | |
| - | |
Options expired/forfeited | |
| - | | |
| - | |
Outstanding at March 31, 2023 | |
| 470,191 | | |
$ | 7.07 | |
On December 21, 2022, the Company granted an award
of 5,000 Class A Common Stock options to each of its directors (a total of 45,000). The stock option award has a four-year vesting period,
vesting 25% per year, and has an exercise price of $3.00. Based upon a Black-Scholes calculation, the price per share to be expensed was
$2.67 and a total cost of $135,000 that would be expensed ratably over 48 months.
On November 16, 2022, the Company granted an award
of 22,843 Class A Common Stock options to Mr. Lehr. The stock option award has a four-year vesting period, vesting 25% per year, and has
an exercise price of $4.30. Based upon a Black-Scholes calculation, the price per share to be expensed was $2.94 and a total cost of less
than $0.1 million would be expensed ratably over 48 months.
On September 6, 2022, the Company granted an award
of 10,000 Class A Common Stock options to an employee. The stock option award has a four-year vesting period, vesting 25%
per year, and has an exercise price of $4.67. Based upon a Black-Scholes calculation, the price per share to be expensed was $4.15 and
a total cost of less than $0.1 million would be expensed ratably over 48 months.
On June 3, 2022, the Company granted an award
of 5,000 Class A Common Stock options to Mr. Lehr. The stock option award vested upon the grant date and has an exercise price of $8.73.
Based upon a Black-Scholes calculation, the price per share to be expensed was $7.73 and a total cost of less than $0.1 million was
expensed on the grant date.
On March 14, 2022, the Company granted an award
of 22,000 Class A Common Stock options to employees. The stock option award has a four-year vesting period, vesting 25%
per year, and has an exercise price of $5.94. Based upon a Black-Scholes calculation, the price per share to be expensed was $5.23 and
a total cost of less than $0.1 million would be expensed ratably over 48 months.
On January 6, 2022, the Company granted awards
of 84,825 Class A Common Stock options to employees. The stock option awards have four-year vesting periods, vesting 25%
per year, and have an exercise price of $10.00. Based upon a Black-Scholes calculation, the price per share to be expensed was $8.78 and
a total cost of $0.7 million would be expensed ratably over 48 months.
For the three months ended March 31, 2023 and
2022, the equity-based compensation expense amounted to approximately $0.4 million and $0.5 million, respectively, which is included
in the research and development and general and administrative expenses in the condensed statements of operations for the three months
ended March 31, 2023 and 2022, respectively.
As of March 31, 2023, the remaining unrecognized
equity-based compensation (which includes RSUs and stock options) of approximately $3.2 million will be recognized over approximately 3.9 years.
9. Commitments
and Contingencies
Master Services Agreements:
As of March 31, 2023, the Company had three active
master services agreements with third parties to conduct its clinical trials and manage clinical research programs and clinical development
services. The Company expects these agreements or amended current agreements to have total expenditures of approximately $3.5 million
over the next two years.
As of December
31, 2022, 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. The Company expects these agreements or amended current
agreements to have total expenditures of approximately $2.9 million over the next two years. 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 $1.0 million over the course of two years.
Consulting Services Agreement:
On November 20, 2014, the Company entered into
a ten-year consulting services agreement with Dr. Joshua Hare, its CSO. Under the agreement, the Company has agreed to pay the CSO $265,000
annually. The compensation payments are for scientific knowledge, medical research, technical knowledge, skills, and abilities to be
provided by the CSO to further develop the intellectual property rights assigned by the CSO to the Company. This agreement requires the
CSO to also assign to the Company the exclusive right, title, and interest in any work product developed from his efforts during the
term of this agreement. On November 16, 2022, the Company accounted for but had not issued 48,140 RSUs convertible to unregistered shares
of Class A Common Stock, with an aggregate value of $0.2 million as payment for accrued expenses under the consulting agreement with
the CSO. As of March 31, 2023 and December 31, 2022, the Company had an accrued balance due to the CSO of less than $0.1 million.
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 50% of
the charges for invoiced services, with such equity to be issued annually on or about the anniversary date of the agreement. During 2017,
the Company issued 1,901 Series C Units, and on November 22, 2019, and January 29, 2021, the Company issued 820 and 410 Series C Units,
respectively, as payment for an aggregate of $0.2 million of accrued technology services. The Series C units were converted to 16,755
Class A common stock shares. As of March 31, 2023 and December 31, 2022, the Company owed less than $0.1 million, pursuant to this agreement,
which is included in accounts payable in the March 31, 2023 and December 31, 2022 condensed balance sheets.
Exclusive Licensing Agreements:
UM Agreement
On November 20, 2014, the Company entered into
an Exclusive License Agreement with UM for the use of certain Aging-related frailty-related MSC technology rights developed by our Chief
Science Officer at UM. The UM License is a worldwide, exclusive license, with right to sublicense, with respect to any and all know-how
specifically related to the development of the culture-expanded MSCs for aging-related frailty used at the IMSCs, all SOPs used to create
the IMSCs, and all data supporting isolation, culture, expansion, processing, cryopreservation and management of the IMSCs. The Company
is required to pay UM (i) a license issue fee of $5,000, (ii) a running royalty in an amount equal to three percent of annual net sales
on products or services developed from the technology, payable on a country-by-country basis beginning on the date of first commercial
sale through termination of the UM License Agreement, and which may be reduced to the extent we are required to pay royalties to a third
party for the same product or process, (iii) escalating annual cash payments of up to fifty thousand dollars, subject to offset. The agreement
extends for up to 20 years from the last date a product or process is commercialized from the technology and was amended in 2017 to modify
certain milestone completion dates as detailed below In 2021 the license fee was increased by an additional $100,000, to defray patent
costs. In addition, the Company issued 110,387 unregistered shares of Class A Common Stock to UM.
The milestone payment amendments shifted the triggering
payments to three payments of $500,000, to be paid within six months of: (a) the completion of the first Phase 3 clinical trial of the
products (based upon the final data unblinding); (b) the receipt by the Company of approval for the first new drug application (“NDA”),
biologics application (“BLA”), or other marketing or licensing application for the product; and (c) the first sale following
product approval. “Approval” refers to Product approval, licensure, or other marketing authorization by the U.S. Food and
Drug Administration, or any successor agency. The amendments also provided for the Company’s license of additional technology, to
the extent not previously included in the UM License and granted the Company an exclusive option to obtain an exclusive license for (a)
the HLHS IND with ckit+ cells; and (b) UMP-438 titled “Method of Determining Responsiveness to Cell Therapy in Dilated Cardiomyopathy.”
The Company has the right to terminate the UM
License upon 60 days’ prior written notice, and either party has the right to terminate upon a breach of the UM License. To date,
the Company has made payments totaling $140,000 to UM, and as of March 31, 2023 and December 31, 2022, we had accrued $92,000 and $50,000
in milestone fees payable to UM, respectively and $100,000 for patent related reimbursements based on the estimated progress to date.
CD271
On December 22, 2016, the Company entered into
an exclusive license agreement with an affiliated entity of Dr. Joshua Hare, JMH MD Holdings, LLC (“JMHMD”), for the use of
CD271 cellular therapy technology. The Company recorded the value of the cash consideration and membership units issued to obtain this
license agreement as an intangible asset. The Company is required to pay as royalty, 1% of the annual net sales of the licensed product(s)
used, leased, or sold by or for licensee or its sub-licensees. If the Company sublicenses the technology, it is also required to pay an
amount equal to 10% of the net sales of the sub-licensees. In addition, on December 23, 2016, as required by the license agreement, the
Company paid an initial fee of $250,000 to JMHMD, and issued to it 10,000 Series C Units, valued at $250,000. The $0.5 million of value
provided to JMHMD for the license agreement, along with professional fees of approximately $27,000, were recorded as an intangible asset
that is amortized over the life of the license agreement which was defined as 20 years. Further, expenses related to the furtherance of
the CD271+ technology is being capitalized and amortized as incurred over 20 years. There were no license fees due for March 31, 2023
and December 31, 2022 pertaining to this agreement.
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.
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. On July 12, 2022, all parties preliminarily
agreed to settle the action for approximately $1.4 million, which amount was accrued as of March 31, 2023, and included in accrued expenses
on the March 31, 2023 condensed balance sheet. The parties are in the process of documenting the settlement and full release, which will
be subject to Court approval. Legal expenses incurred in ordinary business activities are reported within general and administrative expenses.
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 $38,000
and $32,000 to the Plan during the three months ended March 31, 2023 and 2022, respectively.
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:
| |
Three months ended March 31, | |
| |
2023 | | |
2022 | |
RSUs | |
| 356 | | |
| 306 | |
Stock options | |
| 470 | | |
| 304 | |
Warrants | |
| 1,271 | | |
| 1,271 | |
Total | |
| 2,097 | | |
| 1,881 | |
12. Subsequent
Events
On April 3, 2023, a total of 10,648 RSUs granted
in connection with the Company’s IPO vested, of which 9,570 were held by Company employees. Based on the closing price of $2.61
on April 3, 2023, the Company recorded a tax liability of $7,000 for the employees and a corresponding tax liability for the Company of
$2,000. In total, the Company paid $9,000 for employee and employer taxes that resulted from the vesting of RSUs. In order to cover the
employee tax liability, the Company withheld 2,514 shares of Class A Common Stock owned by the Company’s employees upon vesting.
The shares withheld are available for reissuance pursuant to the 2021 Incentive Plan.
On April 18, 2023, the Company finalized the Separation
Agreement dated March 31, 2023, for Dr. Min (Company’s Chief Medical Officer). In part for his agreement to a general release the
Company agreed to pay Dr. Min: $112,000 as severance compensation and the immediate acceleration and vesting of 40,000 RSUs that were
previously granted.
On April 19, 2023, the Company finalized the Separation
Agreement effective June 9, 2023, for Mr. Clavijo (Company’s Chief Financial Officer). In part for his agreement to a general release
the Company agreed to pay Mr. Clavijo $275,000 as severance compensation, three months of payment for COBRA insurance coverage and the
immediate acceleration and vesting of 6,690 RSUs that were previously granted.