Item 9A. Controls and Procedures
ITEM 9A . CONTROLS
AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation
of our management, including our Chief Executive Officer and Chief Financial Officer, we carried out an evaluation of the effectiveness
of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange
Act. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of December 31, 2024,
such disclosure controls and procedures were effective.
Disclosure controls and procedures are controls
and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the
Exchange Act is recorded, processed, summarized and reported within the time periods specified by the SEC. Disclosure controls and procedures
include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed
or submitted under the Exchange Act is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial
Officer, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure.
This Annual Report does not include an attestation
report from our registered public accounting firm regarding internal control over financial reporting. Our internal control over financial
reporting was not subject to such attestation as we are a non-accelerated filer.
46
Limitations on the Effectiveness of Controls
Our disclosure controls and procedures are designed
to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met. Because of inherent limitations
in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have
been detected. Our Chief Executive Officer and Chief Financial Officer have concluded, based on their evaluation as of the end of the
period covered by this Annual Report that our disclosure controls and procedures were effective to provide reasonable assurance that
the objectives of our disclosure control system were met.
Changes in Internal Control Over Financial
Reporting
There were no changes in the Company’s
internal controls over financial reporting that occurred during the fourth quarter of the fiscal year covered by this Annual Report that
have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
Management’s Report on Internal Control
Over Financial Reporting
As required by the SEC rules and regulations
for the implementation of Section 404 of the Sarbanes-Oxley Act, our management is responsible for establishing and maintaining
adequate internal control over financial reporting. Our internal control over financial reporting is designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of our consolidated financial statements for external reporting
purposes in accordance with United States Generally Accepted Accounting Principles (GAAP). Our internal control over financial reporting
includes those policies and procedures that:
(1)
pertain
to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the
assets of our company,
(2)
provide
reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance
with accounting principles generally accepted in the United States of America, and that our receipts and expenditures are being made
only in accordance with authorizations of our management and directors, and
(3)
provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that
could have a material effect on the consolidated financial statements.
Because of its inherent limitations, internal
control over financial reporting may not prevent or detect errors or misstatements in our consolidated financial statements. Also, projections
of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in
conditions, or that the degree or compliance with the policies or procedures may deteriorate. Management assessed the effectiveness of
our internal control over financial reporting as of December 31, 2024. In making these assessments, management used the criteria set
forth by the Committee of Sponsoring Organizations of the Treadway Commission COSO (2013 framework). Based on our assessments and those
criteria, management determined that we did maintain effective internal control over financial reporting as of December 31, 2024.
ITEM 9B. OTHER INFORMATION
Insider Trading Arrangements
No officers, as defined in Rule 16a-1(f), or
directors adopted and/or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,”
as defined in Item 408 of Regulation S-K, during the fourth fiscal quarter of 2024.
ITEM 9C. DISCLOSURE
REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
47
PART III
The information required for the Items contained
in Part III is incorporated herein by reference from our definitive proxy statement for our 2025 Annual Meeting of Stockholders
(the “Proxy Statement”), which will be filed with the SEC no later than 120 days after December 31, 2024.
ITEM 10. DIRECTORS,
EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
ITEM 11. EXECUTIVE COMPENSATION
ITEM 12. SECURITY OWNERSHIP OF CERTAIN
BENEFICIAL OWNERS AND MANAGEMENT
Securities Authorized for Issuance under Equity
Compensation Plans
Relmada has a 2014 Option and Equity Incentive
Plan, as amended (the 2014 Plan) in which its directors, officers, employees and consultants shall be eligible to participate. The 2014
Plan allows for the granting of common stock awards, stock appreciation rights, and incentive and nonqualified stock options to purchase
shares of the Company. On May 20, 2021, at the annual shareholders meeting, our shareholders approved our 2021 Equity Incentive Plan
(the 2021 Plan) which allows for the granting of incentive and nonqualified stock options, stock appreciation rights, restricted stock
awards, performance share awards and other equity-based awards for up to 1,500,000 options or stock awards. At the annual shareholders
meeting on May 25, 2022, our shareholders approved an amendment to the 2021 Plan to increase the shares of the Company’s common
stock available for issuance thereunder by 3,900,000 shares. At the annual shareholders meeting on May 25, 2023, our shareholders approved
an amendment to the 2021 Plan to increase the shares of the Company’s common stock available for issuance thereunder by 2,500,000
shares. At the annual shareholders meeting (currently anticipated for May 23, 2025), our shareholders will vote on a management proposal
to increase the shares authorized for awards under the 2021 Plan by an additional 2,000,000 shares, but there can be no assurance such
amendment will be approved. With these grants and approvals, as of December 31, 2024, the Company had 789,925 shares available to be
issued pursuant to awards under the 2014 or 2021 Plan.
The following table summarizes our equity compensation
plan information as of December 31, 2024:
Equity Compensation Plan Information
Plan Category
Number of
securities to be
issued upon
exercise of
outstanding
options and stock
appreciation
rights
Weighted-
average
exercise
price
of outstanding
options and
stock
appreciation
rights
Number of
securities
remaining
available for
future issuance
under equity
compensation
plans (excluding
securities
reflected in
column (a))
(a)
(b)
(c)
Equity compensation plans approved by security holders (1)
12,263,017
$
16.61
789,925
Equity compensation plans not approved by security holders
-
-
-
Total
12,263,017
$
16.61
789,925
(1) The
2014 and the 2021 Plan, as amended.
The additional information required by this item
will be included in the Proxy Statement, which will be filed with the SEC no later than 120 days after the end of our fiscal year ended
December 31, 2024 and is incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS, AND DIRECTOR INDEPENDENCE
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
48
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
Financial Statement Schedules
Our consolidated financial statements are listed
on the Index to Financial Statements on this Annual Report on Form 10-K beginning on page F-1.
All financial statement schedules are omitted
because they are not applicable or the required information is shown in the financial statements or notes thereto.
Our independent registered public accounting firm is Marcum LLP (PCAOB
ID #688) of Houston, Texas.
49
RELMADA THERAPEUTICS, INC.
(INDEX TO FINANCIAL STATEMENTS)
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID # 688 ) F-2
Consolidated Balance Sheets as of December 31, 2024 and 2023 F-3
Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023 F-4
Consolidated Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2024 and 2023 F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023 F-6
Notes to Consolidated Financial Statements F-7
F- 1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors of
Relmada Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheets of Relmada Therapeutics, Inc. (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements
of operations, changes in stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2024,
and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements
present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of
its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles
generally accepted in the United States of America.
Explanatory Paragraph – Going Concern
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As more fully described in Note 2, the Company has incurred significant
losses and negative cash flows from operations since inception, expects to incur additional losses until such time that it can generate
revenue, and is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements
are issued. These conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in
regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from
the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the
financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were
we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an
understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the
Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to
assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial
statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well
as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
Critical audit matters are matters arising from
the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and
that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ Marcum LLP.
Marcum LLP
We have served as the Company’s auditor since 2014 .
Houston, Texas
March 27, 2025
F- 2
Relmada Therapeutics, Inc.
Consolidated Balance Sheets
As of
As of
December 31,
December 31,
2024
2023
Assets
Current assets:
Cash and cash equivalents
$ 3,857,026
$ 4,091,568
Short-term investments
41,052,356
92,232,292
Prepaid expenses
886,461
1,185,057
Total current assets
45,795,843
97,508,917
Other assets
21,975
43,125
Total assets
$ 45,817,818
$ 97,552,042
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 4,130,563
$ 3,506,009
Accrued expenses
6,160,827
8,688,791
Total current liabilities
10,291,390
12,194,800
Stock appreciation rights
4,467
-
Total liabilities
10,295,857
12,194,800
Commitments and Contingencies (Note 10)
Stockholders’ Equity:
Preferred stock, $ 0.001 par value, 200,000,000 shares authorized, none issued and outstanding
-
-
Class A convertible preferred stock, $ 0.001 par value, 3,500,000 shares authorized, none issued and outstanding
-
-
Common stock, $ 0.001 par value, 150,000,000 shares authorized, 30,174,202 and 30,099,203 shares issued and outstanding, respectively
30,174
30,099
Additional paid-in capital
676,373,822
646,229,824
Accumulated deficit
( 640,882,035 )
( 560,902,681 )
Total stockholders’ equity
35,521,961
85,357,242
Total liabilities and stockholders’ equity
$ 45,817,818
$ 97,552,042
The accompanying notes are an integral part of
these consolidated financial statements.
F- 3
Relmada Therapeutics, Inc.
Consolidated Statements of Operations
For the Years Ended December 31, 2024 and 2023
2024
2023
Operating expenses:
Research and development
$ 46,175,512
$ 54,807,348
General and administrative
37,715,524
48,894,945
Total operating expenses
83,891,036
103,702,293
Loss from operations
( 83,891,036 )
( 103,702,293 )
Other income (expenses):
Interest/investment income, net
3,530,021
5,151,704
Realized gain (loss) on short-term investments
374,926
( 4,064,391 )
Unrealized gain on short-term investments
6,735
3,823,234
Total other income (expenses), net
3,911,682
4,910,547
Net loss
$ ( 79,979,354 )
$ ( 98,791,746 )
Net loss per common share – basic and diluted
$ ( 2.65 )
$ ( 3.28 )
Weighted average number of common shares outstanding –
basic and diluted
30,163,751
30,099,203
The accompanying notes are an integral part of
these consolidated financial statements.
F- 4
Relmada Therapeutics, Inc.
Consolidated Statements of Changes in Stockholders’
Equity
For the Years Ended December 31, 2024 and 2023
Common Stock
Additional
Paid-in
Accumulated
Shares
Par Value
Capital
Deficit
Total
Balance – December 31, 2022
30,099,203
$ 30,099
$ 602,517,138
$ ( 462,110,935 )
$ 140,436,302
Stock-based compensation expense
-
-
43,811,149
-
43,811,149
ATM fees
( 98,463 )
-
( 98,463 )
Net loss
-
-
-
( 98,791,746 )
( 98,791,746 )
Balance – December 31, 2023
30,099,203
30,099
646,229,824
( 560,902,681 )
85,357,242
Stock-based compensation expense
-
-
30,184,414
-
30,184,414
Net proceeds from cash exercise options
74,999
75
246,672
-
246,747
ATM fees
-
-
( 287,088 )
-
( 287,088 )
Net loss
-
-
-
( 79,979,354 )
( 79,979,354 )
Balance – December 31, 2024
30,174,202
$ 30,174
$ 676,373,822
$ ( 640,882,035 )
$ 35,521,961
The accompanying notes are an integral part of
these consolidated financial statements.
F- 5
Relmada Therapeutics, Inc.
Consolidated Statements of Cash Flows
For the Years Ended December 31, 2024 and 2023
2024
2023
Cash flows from operating activities
Net loss
$ ( 79,979,354 )
$ ( 98,791,746 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
30,184,414
43,811,149
Stock appreciation rights compensation
4,467
-
Realized (gain) loss on short-term investments
( 374,926 )
4,064,391
Unrealized gain on short-term investments
( 6,735 )
( 3,823,234 )
Change in operating assets and liabilities:
Other receivable
-
512,432
Prepaid expenses and other assets
319,746
2,841,879
Accounts payable
624,554
( 1,755,927 )
Accrued expenses
( 2,527,964 )
1,481,850
Net cash used in operating activities
( 51,755,798 )
( 51,659,206 )
Cash flows from investing activities
Purchase of short-term investments
( 12,079,628 )
( 90,463,532 )
Sale of short-term investments
63,641,225
140,916,864
Net cash provided by investing activities
51,561,597
50,453,332
Cash flows from financing activities
Payment of ATM fees
( 287,088 )
( 98,463 )
Proceeds from options exercised for common stock
246,747
-
Net cash used in financing activities
( 40,341 )
( 98,463 )
Net decrease in cash and cash equivalents
( 234,542 )
( 1,304,337 )
Cash and cash equivalents at beginning of the year
4,091,568
5,395,905
Cash and cash equivalents at end of the year
$ 3,857,026
$ 4,091,568
The accompanying notes are an integral part of
these consolidated financial statements.
F- 6
Relmada Therapeutics, Inc.
Notes to Consolidated Financial Statements
NOTE 1 - BUSINESS
Relmada Therapeutics Inc. (“Relmada”
or the “Company”) (a Nevada corporation), is a clinical-stage, publicly traded biotechnology company focused on the development
of NDV-01 and Sepranolone.
NDV-01 is a novel, controlled-release intravesical
formulation of gemcitabine and docetaxel. NDV-01 is currently in a Phase 2 clinical trial to assess its safety and efficacy in patients
with aggressive forms of non-muscle invasive bladder cancer (NMIBC).
Sepranolone is a novel neurosteroid epimer of
allopregnanolone. Sepranolone is being developed for the potential treatment of Prader-Willi Syndrome, Tourette Syndrome, excessive tremor
and other diseases related to excessive GABAergic activity.
Esmethadone (d-methadone, dextromethadone, REL-1017),
an N-methyl-D-aspartate (NMDA) receptor antagonist. Esmethadone is a new chemical entity (NCE) that potentially addresses areas of high
unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders. This program has been paused pending
a comprehensive data review.
Relmada was also developing a proprietary, modified-release
formulation of psilocybin (REL-P11) for metabolic indications. This program has also been paused.
In addition to the normal risks associated with
a new business venture, there can be no assurance that the Company’s research and development will be successfully completed or
that any product will be approved or commercially viable. The Company is subject to risks common to companies in the biotechnology industry
including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological
innovations, dependence on key personnel, protection of proprietary technology, and compliance with the Food and Drug Administration
(FDA) and other governmental regulations and approval requirements.
On January 21, 2025, we received a deficiency
letter from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market advising that, for 30 consecutive
business days preceding the notification letter, the Company did not meet the minimum $ 1.00 per share bid price requirement for continued
inclusion on The Nasdaq Global Select Market. The deficiency letter does not result in the immediate delisting of our common stock from
the Nasdaq Global Select Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A) (the “Compliance Period Rule”), we
have been provided an initial period of 180 calendar days, or until July 21, 2025 (the “Compliance Date”), to regain compliance
with the minimum bid price requirement. If, at any time before the Compliance Date, the bid price for our common stock closes at $ 1.00
per share or more for a minimum of 10 consecutive business days, as required by the Compliance Period Rule, the Staff will provide written
notification to us that we comply with the minimum bid price requirement, unless the Staff exercises its discretion to extend this 10-day
period pursuant to Nasdaq Listing Rule 5810(c)(3)(H).
NOTE 2 - GOING CONCERN
These audited consolidated financial statements
have been prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the
realization of assets and the satisfaction of liabilities in the normal course of business.
As shown in the accompanying audited consolidated
financial statements, the Company has incurred losses and negative cash flows from operations since inception and expects to incur additional
losses until such time that it can generate significant revenue from the commercialization of its product candidates. During the twelve
months ended December 31, 2024, the Company incurred a net loss of $ 79,979,354 and had negative operating cash flows of $ 51,755,798 .
Given the Company’s projected operating requirements and its existing cash and cash equivalents and short-term investments, the
Company is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements
are issued. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.
In response to these conditions, management is
currently evaluating the size and scope of any subsequent operations and clinical trials that will affect the timing to obtain the required
funding of future operations. Financing strategies may include, but are not limited to, the public or private sale of equity or debt
securities or from bank or other loans or through strategic collaboration and/or licensing agreements. There can be no assurances that
the Company will be able to secure additional financing, or if available, that it will be sufficient to meet its needs or on favorable
terms. Because management’s plans have not yet been finalized and are not within the Company’s control, the implementation
of such plans cannot be considered probable. As a result, the Company has concluded that management’s plans do not alleviate substantial
doubt about the Company’s ability to continue as a going concern.
The audited consolidated financial statements do not include any adjustments
relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might
result from the outcome of this uncertainty.
F- 7
Relmada Therapeutics, Inc.
Notes to Consolidated Financial Statements
NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements
and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S.
GAAP). The consolidated financial statements include the Company’s accounts and those of the Company’s wholly-owned subsidiary.
All significant intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
The preparation 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 for the
reporting period. Actual results could differ from those estimates. The significant estimates are stock-based compensation expenses,
and recorded amounts related to income taxes.
Cash and Cash Equivalents
The Company considers cash deposits and all highly
liquid investments with a maturity of three months or less when purchased to be cash and cash equivalents. The Company’s cash deposits
are held at two high-credit-quality financial institutions. The Company’s cash and cash equivalents are carried at cost, which
approximates their fair value. The Company’s cash and cash equivalents of $ 3,857,026 and $ 4,091,568 at December 31, 2024 and 2023,
respectively, at these institutions exceed federally insured limits.
Short-term Investments
The Company’s investments consist entirely
of mutual funds. The securities are measured at fair value based on the net asset value “NAV”. Substantially all equity investments
in nonconsolidated entities are measured at fair value with recurring changes recognized in earnings, except for those accounted for
using equity method accounting. Changes in fair value of the securities are recorded as part of other income on the consolidated statements
of operations. Short term investment activity is presented in the investing activities section on the consolidated statements of cash
flows.
Short-term investments at December 31, 2024
and 2023 consisted of mutual funds with a fair value of $ 41,052,356 and 92,232,292 , respectively.
Patents
Costs related to filing and pursuing patent applications
are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures is uncertain.
Leases
The Company recognizes its leases with a term
of greater than a year on the balance sheet by recording right-of-use assets and lease liabilities. Leases can be classified as either
operating leases or finance leases. Operating leases will result in straight-line lease expense, while finance leases will result in
front-loaded expense. The Company’s leases consists of operating leases for office space for terms of 12 months or less. The Company
does not recognize a lease liability or right-of-use asset on the balance sheet for short-term leases. Instead, the Company recognizes
short-term lease payments as an expense on a straight-line basis over the lease term. A short-term lease is defined as a lease that,
at the commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that
the lessee is reasonably certain to exercise.
F- 8
Relmada
Therapeutics, Inc.
Notes to Consolidated Financial Statements
Fair Value of Financial Instruments
The Company’s financial instruments primarily
include cash, short-term investments, and stock appreciation rights. Due to the short-term nature of cash and accounts payable the carrying
amounts of these assets and liabilities approximate their fair value.
Fair value is defined as the price that
would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants
at the reporting date. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices
in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. The fair value hierarchy is as
follows:
Level 1 Inputs - Unadjusted quoted
prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.
Level 2 Inputs - Inputs other than
quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. These might include
quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets
that are not active, inputs other than quoted prices that are observable for the asset or liability (such as interest rates, volatilities,
prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation or other
means.
Level 3 Inputs - Prices or valuation
techniques that require inputs that are both significant to the fair value measurement and unobservable (supported by little or no market
activity).
As required by Accounting Standard Codification
(ASC) Topic No. 820 - 10 Fair Value Measurement , financial assets and liabilities are classified based on the lowest level of
input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to
the fair value measurement requires judgment and may affect the valuation of the fair value of assets and liabilities and their placement
within the fair value hierarchy levels.
The Company’s short-term investment instruments
of $ 41,052,356 and $ 92,232,292 at December 31, 2024 and 2023, respectively, are classified using Level 1 inputs within the fair
value hierarchy because they are valued using NAV. Unrealized gains and losses are recorded in the consolidated statement of operations
as unrealized gain on short-term investments. The Company recorded unrealized gains of $ 6,735 and of $ 3,823,234 , included in other income
(expense) for the years ended December 31, 2024 and 2023, respectively.
The Company’s stock appreciation rights
liability is a mark-to-market liability and classified within Level 3 of the fair value hierarchy as the Company is using a Black-Scholes
option pricing model. Significant unobservable inputs included expected term and volatility. The expected term was calculated using
the simplified method. The volatility is calculated based on the Company’s historical stock price over a period of time.
F- 9
Relmada
Therapeutics, Inc.
Notes to Consolidated Financial Statements
As of December 31, 2024, the stock appreciation
rights liability had a fair value of $ 4,467 . Significant inputs for Level 3 stock appreciation rights liability fair value measurement
at December 31, 2024 are (1) discount rate of 4.38 %, (2) expected life of 5.75 years, (3) expected volatility of 129 %, (4) zero expected
dividends, (5) stock price of $ 0.52 and (6) exercise price of $ 3.84 - $ 3.69 .
There have been no transfers in and out of level 3 during the year
ended December 31, 2024.
Income Taxes
The
Company accounts for income taxes using the asset and liability method. Accordingly, deferred
tax assets and liabilities are recognized for the future tax consequences attributable to
differences between financial statement carrying amounts of existing assets and liabilities
and their respective tax bases. 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 the tax rate is recognized in income or expense in the period that the change
is effective. Tax benefits are recognized when it is probable that the deduction will be
sustained. A valuation allowance is established when it is more likely than not that all
or a portion of a deferred tax asset will either expire before the Company is able to realize
the benefit, or that future deductibility is uncertain. At December 31, 2024 and 2023, the
Company had recognized a valuation allowance to the full extent of the Company’s net
deferred tax assets since the likelihood of realization of the benefit does not meet the
more likely than not threshold.
The Company files a U.S. Federal income tax return
and various state returns. Uncertain tax positions taken on the Company’s tax returns will be accounted for as liabilities for
unrecognized tax benefits. The Company will recognize interest and penalties, if any, related to unrecognized tax benefits in general
and administrative expenses in the statements of operations. There were no liabilities recorded for uncertain tax positions at December
31, 2024 and 2023. The open tax years, subject to potential examination by the applicable taxing authority, for the Company are from
December 31, 2020 forward.
Research and Development
Research and development costs primarily consist
of research contracts for the advancement of product development, salaries and benefits, stock-based compensation, and consultants. The
Company expenses all research and development costs in the period incurred. The Company makes an estimate of costs in relation to clinical
study contracts. The Company analyzes the progress of studies, including the progress of clinical studies and phases, invoices received
and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability.
Stock-Based Compensation
The Company measures the cost of employee services
received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over
the period during which an employee is required to provide service in exchange for the award - the requisite service period. The grant-date
fair value of employee share options is estimated using the Black-Scholes option pricing model adjusted for the unique characteristics
of those instruments.
Stock Appreciation Rights
Pursuant to the terms of the Company’s
2021 Equity Incentive Plan, the Company may grant cash-settled Stock Appreciation Rights (“SARs”) that are classified as
liabilities under ASC 718 ( Compensation—Stock Compensation ). These SARs allow employees to receive cash payments based on
the appreciation of the Company’s stock price over a specified period.
The initial fair value of SARs is determined
on the grant date using the Black-Scholes option pricing model. SARs are remeasured at fair value at each reporting date using the Black-Scholes
pricing model until they are exercised or expire. Changes in fair value are recognized in the income statement as a compensation expense.
Compensation expense is recognized over the service period, which is the period during which employees are required to provide service
in exchange for the award.
Upon exercise, the Company will settle SARs in cash based on the difference
between the fair value of the underlying shares at the exercise date and the exercise price.
Net Loss per Common Share
Basic loss per common share attributable to common
stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares
outstanding for the period, without consideration for common stock equivalents. Diluted loss per common share attributable to common
stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common share
equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of
options and warrants to purchase common stock. For all periods presented, there is no difference in the number of shares used to calculate
basic and diluted shares outstanding due to the Company’s net losses in each period.
F- 10
Relmada Therapeutics, Inc.
Notes to Consolidated Financial Statements
The potentially dilutive securities that would
be anti-dilutive due to the Company’s net loss are not included in the calculation of diluted net loss per share attributable to
common stockholders. The anti-dilutive securities are as follows (in common stock equivalent shares):
Year ended
December 31,
Year ended
December 31,
2024
2023
Common stock warrants
1,382,613
2,381,366
Common stock options
12,263,017
17,416,192
Total
13,645,630
19,797,558
Adoption of Recent Accounting Standards
In October 2021, the FASB issued ASU 2021-08,
“ Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers ”.
The amendments in this ASU require that an entity (acquirer) recognize, and measure contract assets and contract liabilities acquired
in a business combination, including contract assets and contract liabilities arising from revenue contracts with customers, as if it
had originated the contracts as of the acquisition date. The amendments in this ASU were effective for annual and interim periods beginning
after December 15, 2022. The Company adopted this standard effective January 1, 2023 and the standard did not have a significant impact
on our consolidated financial statements.
In November 2023, The FASB issued ASU 2023-07,
“ Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures ” which expands annual and interim disclosures
for reportable segments, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for our
annual periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted. The Company
adopted this standard effective January 1, 2024 and the standard did not have significant impact on our consolidated financial statements.
Recent Accounting Standards
In
December 2023, the FASB issued ASU 2023-09, “ Income Taxes (Topic 740): Improvements
to Income Tax Disclosures ” to expand the disclosure requirements for income taxes,
specifically related to the rate reconciliation and income taxes paid. ASU 2023-09 is effective
for our annual periods beginning January 1, 2025, with early adoption permitted. The Company
is currently evaluating the potential effect that the updated standard will have on our financial
statement disclosures.
In November 2024, the FASB issued ASU 2024-03,
Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40) . ASU 2024-03 requires
specified information about certain costs and expenses be disclosed in the notes to the financial statements, including the expense caption
on the face of the income statement in which they are disclosed, in addition to a qualitative description of remaining amounts not separately
disaggregated. Entities will also be required to disclose their definition of “selling expenses” and the total amount in
each annual period. The standard is effective for the Company for annual periods beginning January 1, 2027 and for interim periods beginning
January 1, 2028, with updates applied either prospectively or retrospectively. Early adoption is permitted. The Company is currently
evaluating the impact of this guidance on its disclosures.
Subsequent Events
The Company’s management reviewed all material
events through the date the audited consolidated financial statements were issued for subsequent event disclosure consideration.
NOTE 4 - PREPAID EXPENSES
Prepaid expenses consisted of the following (rounded to nearest $00):
December 31,
2024
December 31,
2023
Insurance
$ 403,100
$ 365,100
Research and Development
391,200
695,000
Other
92,200
125,000
Total
$ 886,500
$ 1,185,100
NOTE 5 - ACCRUED EXPENSES
Accrued expenses consisted of the following (rounded to nearest $00):
December 31,
2024
December 31,
2023
Research and development
$ 4,514,800
$ 5,394,700
Professional fees
362,600
174,000
Accrued bonus
732,300
2,632,400
Accrued vacation
421,700
372,200
Other
129,400
115,500
Total
$ 6,160,800
$ 8,688,800
F- 11
Relmada Therapeutics, Inc.
Notes to Consolidated Financial Statements
NOTE 6 - STOCK APPRECIATION RIGHTS
During the year ended December 31, 2024, 110,000
cash-settled stock appreciation rights have been issued to employees with an exercise price of $ 3.84 - $ 3.69 respectively with a 10 -year
term and vesting over a 4 -year period. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 3.87 –
4.15 %, (2) expected life of 6.25 years, (3) expected volatility of 113 %, and (4) zero expected dividends.
At December 31, 2024, the Company revalued the
cash-settled stock appreciation rights using a stock price of $ 0.52 and an exercise price of $ 3.84 - $ 3.69 . Variables used in the Black-Scholes
option-pricing model include: (1) discount rate of 4.38 %, (2) expected life of 5.75 years, (3) expected volatility of 129 %, and (4) zero
expected dividends.
As of December 31, 2024, the total liability
related to cash-settled SARs is $ 4,467 , reflecting the fair value as of the reporting date. During the year ended December 31, 2024,
the Company recorded compensation related to the cash-settled SARs in the amount of $ 4,467 , included in research and development expenses
in the accompanying consolidated statements of operations.
A summary of the changes in SARs during the nine months ended December
31, 2024 is as follows.
Number of Cash-Settled
SARS Weighted
Average
Exercise
Price Weighted
Average
Remaining
Contractual
Term Aggregate
Intrinsic
Value
Outstanding at December 31, 2023 -
$ -
-
$ -
Granted 110,000 $ 3.70 9.58 $ -
Outstanding at December 31, 2024 110,000 $ 3.70 9.58 $ -
SARs vested at December 31, 2024 -
$ -
- $ -
At December 31, 2024, the Company has unrecognized
compensation expense of approximately $ 38,000 related to unvested stock appreciation rights which will be recognized over the weighted
average remaining service period of 3.58 years.
NOTE 7 - STOCKHOLDERS’ EQUITY
Common Stock
During the years ended December 31, 2024 and
2023, the Company did not issue any shares of common stock for the exercise of warrants.
During the year ended December 31, 2024, the
Company issued 74,999 shares of common stock for the exercise of options for proceeds of $ 246,747 .
During the year ended December 31, 2023, the
Company did not issue any shares of common stock for the exercise of options.
On April 6, 2022, the Company entered into a
new Open Market Sale Agreement with Jefferies LLC, as sales agent, pursuant to which we may offer and sell, from time to time, through
Jefferies LLC, shares of our common stock, having an aggregate offering price of up to $ 100,000,000 . We are not obligated to sell any
shares under the agreement. As of December 31, 2024, no shares have been issued under this agreement.
During the years ended December 31, 2024 and
2023, there were no common stock shares issued for issuances of restricted common stock.
F- 12
Relmada Therapeutics, Inc.
Notes to Consolidated Financial Statements
NOTE 8 - OPTIONS AND WARRANTS
In December 2014, the Board of Directors adopted
and the Company’s shareholders approved Relmada’s 2014 Stock Option and Equity Incentive Plan, as amended (the “2014
Plan”), which allows for the granting of 5,152,942 common stock awards, stock appreciation rights, and incentive and nonqualified
stock options to purchase shares of the Company’s common stock to designated employees, non-employee directors, and consultants
and advisors.
In May 2021, the Company’s Board of Directors
adopted and shareholders approved Relmada’s 2021 Equity Incentive Plan (the “2021 Plan”) which allows for the granting
of 1,500,000 options or other stock awards.
In May 2022, the Company’s Board of Directors
adopted, and shareholders approved an amendment to the 2021 Plan to increase the shares of the Company’s common stock available
for issuance thereunder by 3,900,000 shares.
In May 2023, the Company’s Board of Directors
adopted and shareholders approved an amendment to the 2021 Plan to increase the shares of the Company’s common stock available
for issuance thereunder by 2,500,000 shares.
These combined plans allowed for the granting
of up to 13,052,942 options or other stock awards.
Stock options are exercisable generally for a
period of 10 years from the date of grant and generally vest over four years .
As of December 31, 2024, there were 789,925 shares
available to be granted under either the 2014 and 2021 Plan.
The Company uses the simplified method for share-based
compensation to estimate the expected term for employee option awards for share-based compensation in its option-pricing model.
From January 1, 2024 through December 31, 2024,
the Company awarded a total of 487,434 options to consultants and employees with an exercise price ranging from $ 3.05 to $ 3.44 and
a 10 -year term vesting over a 3.56 - 4 year period. The options granted include time-based vesting grants. The options have an
aggregate fair value of approximately $ 1,300,000 calculated using the Black Scholes option-pricing model. Variables used in the
Black-Scholes option-pricing model include: (1) discount rate of 4.10 – 4.51 % (2) expected life of 5.92 - 6.25 years,
(3) expected volatility of 113.5 - 114.1 %, and (4) zero expected dividends.
From November 13, 2023 through December 15, 2023,
the Company awarded a total of 5,010,000 options to consultants and employees with an exercise price ranging from $ 2.48 to
$ 2.82 and a 10 -year term vesting over a 4 -year period. The options granted include time-based vesting grants. The options
have an aggregate fair value of approximately $ 10,703,070 calculated using the Black Scholes option-pricing model. Variables used
in the Black-Scholes option-pricing model include: (1) discount rate of 3.93 – 4.68 % (2) expected life of 6.25 years,
(3) expected volatility of 113 - 114 %, and (4) zero expected dividends.
From August 1, 2023 through September 18, 2023, 10,000 options
were issued to various employees with an exercise price ranging from $ 2.56 to $ 2.96 and a 10 -year term, vesting over a 4 -year
period. The options granted include time-based vesting grants. The options have an aggregate fair value of approximately $ 23,840 calculated
using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 4.20 – 4.44 %
(2) expected life of 6.25 years, (3) expected volatility of 113 - 114 %, and (4) zero expected dividends.
From April 10, 2023 through June 20, 2023, 60,000 options
were issued to various employees with an exercise price ranging from $ 2.28 to $ 3.32 and a 10 -year term, vesting over a 4 -year
period. The options granted include time-based vesting grants. The options have an aggregate fair value of approximately $ 148,420 calculated
using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 3.43 – 3.91 %
(2) expected life of 6.25 years, (3) expected volatility of 114 %, and (4) zero expected dividends.
From January 6, 2023 through February 21, 2023,
620,000 options were issued to various consultants and employees with an exercise price ranging from $ 3.18 to $ 4.30 and a 10 -year term,
vesting over a 4 -year period. The options have an aggregate fair value of approximately $ 1,933,613 calculated using the Black-Scholes
option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 3.46 – 4.12 % (2) expected
life of 6.25 years, (3) expected volatility of 115 - 116 %, and (4) zero expected dividends.
F- 13
Relmada Therapeutics, Inc.
Notes to Consolidated Financial Statements
Options
A summary of the changes in options outstanding
for the years ended December 31, 2024 and 2023 is as follows:
Number of
Shares Weighted
Average
Exercise
Price Per
Share Weighted
Average
Remaining
Contractual
Term
(Years) Aggregate Intrinsic
Value
Outstanding and expected to vest at December 31, 2022 12,122,606 $ 18.19 8.5 $ 417,998
Granted 5,700,000 2.61 9.9 -
Forfeited ( 406,414 ) -
- -
Outstanding and expected to vest at December 31, 2023 17,416,192 $ 12.99 8.3 $ 11,183,370
Granted 487,434 3.10
Forfeited and cancelled ( 5,565,610 ) -
Exercised ( 74,999 ) -
Outstanding and expected to vest at December 31, 2024 12,263,017 $ 16.61 6.01 $ -
Options exercisable at December 31, 2024 9,480,618 $ 19.02 5.44 $ -
At December 31, 2024, the Company has unrecognized
stock-based compensation expense of approximately $ 16,289,000 related to unvested stock options over the weighted average remaining service
period of 1.40 years. The weighted average fair value of options granted during the years ended December 31, 2024 and 2023 was approximately
$ 3.10 and $ 2.61 per share, respectively, on the date of grant using the Black-Scholes option pricing model with the following assumptions:
Years Ended
Years Ended
December 31,
December 31,
2024
2023
Risk free interest rate
4.10 to 4.51 %
3.43 to 4.68 %
Dividend yield
0 %
0 %
Volatility
113.5 - 114.1 %
113 - 116 %
Expected term (in years)
5.92 - 6.25
6.25
F- 14
Relmada Therapeutics, Inc.
Notes to Consolidated Financial Statements
Warrants
A summary of the changes in outstanding warrants
during the years ended December 31, 2024 and 2023 is as follows:
Number of
Shares
Weighted
Average
Exercise
Price Per
Share
Outstanding at December 31, 2022
3,027,441
$ 17.02
Forfeited
( 646,075 )
$ 1.5
Outstanding at December 31, 2023
2,381,366
$ 20.02
Forfeited
( 998,753 )
$ 2.31
Outstanding at December 31, 2024
1,382,613
$ 28.74
Warrants exercisable at December 31, 2024
1,372,113
$ 28.76
There were no warrants issued
during the year ended December 31, 2024.
At December 31, 2024, the Company had approximately
$ 167,300 of unrecognized stock-based compensation expense related to outstanding warrants. At December 31, 2024, the aggregate intrinsic
value of warrants vested and outstanding was $ 0 .
Stock-based compensation by class of expense
The following summarizes the components of stock-based
compensation expense which includes stock options and warrants in the consolidated statements of operations (rounded to nearest $00):
Year Ended
Year Ended
December 31,
December 31,
2024
2023
Research
and development
$ 5,933,200
$ 7,224,000
General
and administrative
24,251,200
36,587,100
Total
$ 30,184,400
$ 43,811,100
F- 15
Relmada Therapeutics, Inc.
Notes to Consolidated Financial Statements
NOTE 9 - INCOME TAXES
No provision or benefit for federal or state
income taxes has been recorded because the Company has incurred net losses for all periods presented and has recorded a valuation allowance
against its deferred tax assets.
The components of the Company’s deferred
tax assets are as follows at:
December 31,
2024
December 31,
2023
Deferred tax assets:
Federal net operating loss
$ 26,679,000
$ 21,016,000
State net operating loss
1,554,000
3,771,000
Research and development tax credits
3,953,000
2,238,000
Capitalized R&D
42,843,000
49,581,000
Nonqualified Stock Options
29,040,000
29,305,000
Accruals
1,398,000
1,616,000
Intangibles and Fixed Assets
2,118,000
2,599,000
NUBIL-382
7,763,000
-
Other
11,000
11,000
Less: valuation allowance
( 115,359,000 )
( 110,137,000 )
Total
$ -
$ -
The Company has maintained a full valuation allowance
against its deferred tax assets at December 31, 2024 and 2023. A valuation allowance is required to be recorded when it is more likely
than not that some portion or all of the net deferred tax assets will not be realized. Since the Company cannot be assured of realizing
the net deferred tax asset, a full valuation allowance has been provided. The valuation allowance (decreased)/increased for the years
ended December 31, 2024 and 2023 by approximately $ 5,222,000 and $( 6,259,000 ), respectively. Deferred tax asset for net operating loss
carryforwards at December 31, 2024 was adjusted with the corresponding offset to valuation allowance.
At December 31, 2024, the Company had federal,
New York State and New York City net operating loss (NOL) carryforwards of approximately $ 127,041,000 , $ 1,068,000 and $ 1,068,000 , respectively,
which begin expiring in 2027, 2032 and 2032, respectively. Approximately $ 127,041,000 federal NOL can be carried forward indefinitely
but it is limited to 80 % of future taxable income. The Company also has federal research and development tax credit carryforwards of
approximately $ 3,953,000 that will begin to expire in 2042.
Sections 382 and 383 of the Internal Revenue
Code of 1986 subject the future utilization of net operating losses and certain other tax attributes, such as research and development
tax credits, to an annual limitation in the event of certain ownership changes, as defined. The Company has undergone an ownership change
and has determined that various “changes in ownership” as defined by IRS Section 382 did occur. Accordingly, about $111,168,000
of the Company’s NOL carryforwards are limited. Approximately, $ 53,028,000 of NOLs and $ 7,321,000 of R&D Credits are expected
to expire unused. The deferred tax assets associated with the attributes that will expire without utilization have been written-off.
There are approximately $ 68,900,000 of NOLs available for in 2024. In subsequent years, the NOLs available from the October 13, 2022
change under section 382 are $ 740,000 , annually.
A reconciliation of the statutory tax rate to
the effective tax rate is as follows:
Year Ended
December 31,
2024
Year Ended
December 31,
2023
Statutory federal income tax rate
21.00 %
21.00 %
State (net of federal benefit)
( 14.27 )%
( 6.56 )%
Non-deductible expenses
( 2.58 )%
( 5.34 )%
R&D Credit
2.15 %
1.70 %
NOL and R&D adjustment due to 382
( 2.72 )%
( 16.27 )%
NUBIL – 382 adjustment
5.23 %
0.00 %
Permanent true-ups
( 2.28 )%
( 0.89 )%
Other
0.00 %
0.02 %
Change in valuation allowance
( 6.53 )%
6.34 %
Effective income tax rate
0 %
0 %
The Company does not have any uncertain tax positions
at December 31, 2024 and 2023, that would affect its effective tax rate. The Company does not anticipate a significant change in the
amount of unrecognized tax benefits over the next twelve months. Because the Company is in a loss carryforward position, the Company
is generally subject to US federal and state income tax examinations by tax authorities for all years for which a loss carryforward is
available. If and when applicable, the Company will recognize interest and penalties as part of income tax expense.
F- 16
Relmada Therapeutics, Inc.
Notes to Consolidated Financial Statements
NOTE 10 - COMMITMENTS AND CONTINGENCIES
License Agreements
Third Party Licensor
Based upon a prior acquisition, the Company assumed
an obligation to pay a third party (Dr. Charles E. Inturrisi and Dr. Paolo Manfredi – see below): (A) royalty payments up to 2 %
on net sales of licensed products that are not sold by sublicensee and (B) on each and every sublicense earned royalty payment received
by licensee from its sublicensee on sales of license product by sublicensee, the higher of (i) 20 % of the royalties received by licensee;
or (ii) up to 2 % of net sales of sublicensee. The Company will also make milestone payments of up to $ 4 or $ 2 million, for the first
commercial sale of product in the field that has a single active pharmaceutical ingredient, and for the first commercial sale of product
in the field of product that has more than one active pharmaceutical ingredient, respectively. As of December 31, 2024, the Company has
not generated any revenue related to this license agreement.
Inturrisi / Manfredi
In January 2018, the Company entered into
an Intellectual Property Assignment Agreement (the Assignment Agreement) and License Agreement (the License Agreement and together with
the Assignment Agreement, the Agreements) with Dr. Charles E. Inturrisi and Dr. Paolo Manfredi (collectively, the Licensor). Pursuant
to the Agreements, Relmada assigned its existing rights, including patents and patent applications, to esmethadone in the context of
psychiatric use (the Existing Invention) to Licensor. Licensor then granted Relmada under the License Agreement a perpetual, worldwide,
and exclusive license to commercialize the Existing Invention and certain further inventions regarding esmethadone in the context of
other indications such as those contemplated above. In consideration of the rights granted to Relmada under the License Agreement, Relmada
paid the Licensor an upfront, non-refundable license fee of $ 180,000 . Additionally, Relmada will pay Licensor $ 45,000 every three months
until the earliest to occur of the following events: (i) the first commercial sale of a licensed product anywhere in the world, (ii)
the expiration or invalidation of the last to expire or be invalidated of the patent rights anywhere in the world, or (iii) the termination
of the License Agreement. Relmada will also pay Licensor tiered royalties with a maximum rate of 2 %, decreasing to 1.75 %, and 1.5 % in
certain circumstances, on net sales of licensed products covered under the License Agreement. Relmada will also pay Licensor tiered payments
up to a maximum of 20 %, and decreasing to 17.5 %, and 15 % in certain circumstances, of all consideration received by Relmada for sublicenses
granted under the License Agreement. As of December 31, 2024, no events have occurred, and the Company continues to pay Licensor $ 45,000
every three months.
Arbormentis, LLC
On July 16, 2021, the Company entered into a
License Agreement with Arbormentis, LLC, a privately held Delaware limited liability company, by which the Company acquired development
and commercial rights to a novel psilocybin and derivate program from Arbormentis, LLC, worldwide excluding the countries of Asia.
The Company will collaborate with Arbormentis, LLC on the development of new therapies targeting neurological and psychiatric disorders,
leveraging its understanding of neuroplasticity, and focusing on this emerging new class of drugs targeting the neuroplastogen mechanism
of action. Under the terms of the License Agreement, the Company paid Arbormentis, LLC an upfront fee of $ 12.7 million, consisting
of a mix of cash and warrants to purchase the Company’s common stock, in addition to potential milestone payments totaling up to
approximately $ 160 million related to pre-specified development and commercialization milestones. Arbormentis, LLC is also eligible
to receive a low single digit royalty on net sales of any commercialized therapy resulting from this agreement. The license agreement
is terminable by the Company but is perpetual and not terminable by the licensor absent material breach of its terms by the Company.
The new licensed program stems from an international
collaboration among U.S., European and Swiss scientists that has focused on the discovery and development of compounds that may promote
neural plasticity.
Leases and Subleases
On August 1, 2021, the Company relocated its corporate headquarters to 2222 Ponce de Leon, Floor 3, Coral Gables, FL 33134, pursuant to a lease agreement with monthly rent of approximately $ 11,000 . The lease period was for five months . The lease agreement expired on December 31, 2021 and was renewed for each subsequent year with monthly rent for the years end December 31, 2024 and 2023 of approximately $ 7,000 and $ 7,000 , respectively.
F- 17
Relmada Therapeutics, Inc.
Notes to Consolidated Financial Statements
Beginning on January 1, 2023, we also leased
office space at 880 Third Avenue, 12 th Floor, New York, NY 10022 with monthly rent of approximately $ 14,500 that was terminated
on November 30, 2023 .
Beginning on December 1, 2023, we leased office
space at 12 E 49 th Street, New York, NY 10022 for with monthly rent of approximately $ 12,000 that lease was terminated on
May 31, 2024 .
Beginning
on May 29, 2024, we leased office space at 12 E 49 th Street, New York, NY 10022 with monthly rent of approximately $ 10,500 ;
that lease expires on May 30, 2025 .
In accordance with ASC 842, Leases , the
Company has elected the practical expedient and recognizes rent expense evenly over the 12 months.
The Company incurred rent expense of approximately
$ 236,900 and $ 283,600 for the years ended December 31, 2024 and 2023, respectively.
Legal
From time to time, the Company may become involved
in lawsuits and other legal proceedings that arise in the course of business. Litigation is subject to inherent uncertainties, and it
is not possible to predict the outcome of litigation with total confidence. The Company is currently not aware of any legal proceedings
or potential claims against it whose outcome would be likely, individually or in the aggregate, to have a material adverse effect on
the Company’s business, financial condition, operating results, or cash flows.
NOTE
11 - OTHER POSTRETIREMENT BENEFIT PLAN
Relmada participates in a multiemployer 401(k)
plan that permits eligible employees to contribute funds on a pretax basis subject to maximum allowed under federal tax provisions. The
Company matches 100 % of the first 3 % of employee contributions, plus 50 % of employee contributions that exceed 3 % but do not exceed 5 %.
The employees choose an amount from various investment
options for both their contributions and the Company’s matching contribution. The Company’s contribution expense was $ 135,298
and $ 140,982 for the years ended December 31, 2024 and 2023, respectively.
NOTE 12 – SEGMENT REPORTING
The Company determined its reporting units in
accordance with ASC 280, Segment Reporting . Reportable operating segments are determined based on the management approach, as
defined by ASC 280, is based on the way that the chief operating decision-maker (CODM) organizes segments within the Company for making
operating decisions, assessing performance, and allocating resources. Reportable segments are based on products and services, geography,
legal structure, management structure, or any other manner in which management disaggregates the Company.
Management determined the Company’s operations
constitute a single reportable segment in accordance with ASC 280: clinical stage drug development. The Company derives all of its losses
from the development of clinical stage drugs expenses. The Company’s CODM is its chief executive officer and chief financial officer.
The CODM assesses performance and makes operating decisions about allocating resources based on the research and development operating
expenses on the Consolidated Statements of Operations. The CODM does not review assets in evaluating the results of the clinical stage
development, and therefore, such information is not presented.
The following table provides the operating expenses
of our clinical stage drug development segment (rounded to the nearest $00):
December 31,
December 31,
2024
2023
Clinical Study Expense
$ 11,376,200
$ 20,043,700
Other Research Expense
23,616,000
22,367,300
Manufacturing and Drug Storage Expense
1,567,400
1,542,300
Pre-clinical Expense
328,900
-
Compensation Expense
3,349,400
3,630,100
Stock-based Compensation Expense
5,937,600
7,224,000
Total Research and Development Expense
$ 46,175,500
$ 54,807,400
NOTE 13 - SUBSEQUENT EVENTS
On January 2, 2025, 300,000 Cash-Settled Stock
Appreciation Rights were granted to a consultant with an exercise price of $ 0.45 .
On February 3, 2025, the Company entered into
an Asset Purchase Agreement (the Purchase Agreement) with Asarina Pharma AB (Asarina), a Swedish corporation, pursuant to which the Company
has agreed, subject to the terms and conditions set forth therein, to purchase from Asarina all right, title, and interest in Sepranolone,
a phase 2b ready neurosteroid being developed for the potential treatment of Prader-Willi Syndrome, Tourette Syndrome, essential tremor
and other diseases related to excessive GABAergic activity. The total purchase price for Sepranolone is € 3,000,000 . The Company paid Asarina
$ 2,756,000 on February 5, 2025, which includes a credit of $ 250,000 for a previous payment made by the Company to Asarina pursuant to
an exclusivity agreement dated October 25, 2024.
On March 24, 2025, the Company entered into an
Exclusive License Agreement with Trigone Pharma, Ltd. (Trigone), an Israeli company. The license agreement is for Trigone’s NDV-01
product, which is a novel, sustained-release, intravesical gemcitabine/docetaxel, ready-for-use product candidate for the treatment of
NMIBC. Under the terms of the agreement, the Company made a $ 3,500,000 upfront payment on March 25, 2025, and issued 3,017,420 shares
of common stock, which represent 10 % of the Company’s outstanding shares, for exclusive worldwide rights to NDV-01, excluding Israel,
India and South Africa.
In addition, the Company will pay up to $ 200 million
in development, regulatory and sales milestones pending successful commercialization. The Company will also pay a royalty of 3 % on any
net sales. Following the completion of the ongoing Phase 2 study, the Company will assume responsibility for NDV-01’s development,
manufacturing and commercialization.
On March 24, 2025, the Company awarded a total
of 200,000 options to consultants with an exercise price of $ 0.30 and a 10 -year term vesting over a four-year period.
F- 18
Exhibits
Certain of the agreements filed as exhibits to
this Annual Report contain representations and warranties by the parties to the agreements that have been made solely for the benefit
of the parties to the agreement. These representations and warranties:
●
may have been qualified
by disclosures that were made to the other parties in connection with the negotiation of the agreements, which disclosures are not
necessarily reflected in the agreements;
●
may apply standards of
materiality that differ from those of a reasonable investor; and
●
were made only as of specified
dates contained in the agreements and are subject to subsequent developments and changed circumstances.
Accordingly, these representations and warranties
may not describe the actual state of affairs as of the date that these representations and warranties were made or at any other time.
Investors should not rely on them as statements of fact.
Exhibit
Number
Description
2.1
Share
Exchange Agreement, dated May 20, 2014, by and among Camp Nine, Inc., Relmada Therapeutics, Inc., and the stockholders of Relmada
Therapeutics, Inc. (incorporated by reference to Exhibit 2.1 of Relmada’s Form 8-K filed with the SEC on May 27, 2014).
3.1
(i)
Articles of Incorporation of Camp Nine, Inc. (incorporated by reference to Exhibit 3.1 of Relmada’s Registration Statement
on Form S-1 filed with the SEC on November 13, 2012).
(ii)
Certificate of Designation dated May 13, 2014 (incorporated by reference to Exhibit 4.1 to Relmada’s Report on Form 8-K filed
with the SEC on May 19, 2014).
(iii)
Nevada Certificate of Amendment to Articles of Incorporation of Camp Nine, Inc., effective May 30, 2014 (incorporated by reference
to Exhibit 3.1 of Relmada’s Form 8-K filed with the SEC on June 2, 2014).
(iv)
Nevada Certificate of Amendment to Articles of Incorporation of Camp Nine, Inc., effective July 8, 2014 (incorporated by reference
to Exhibit 3.1 of Relmada’s Form 8-K filed with the SEC on July 14, 2014).
(v)
Certificate of Change of Relmada Therapeutics, Inc. dated September 26, 2019 (incorporated by reference to Exhibit 3.1 of Relmada’s
Form 8-K filed with the SEC on September 27, 2019).
(vi)
Certificate of Amendment to Articles of Incorporation dated September 22, 2022 (incorporated by reference to Exhibit 3.1 of Relmada’s
Form 8-K filed with the SEC on September 22, 2022).
3.2
Second
Amended and Restated Bylaws of Relmada Therapeutics, Inc. (incorporated by reference to Exhibit 3.2 of Relmada’s Form 8-K filed
with the SEC on November 25, 2015).
50
Exhibit
Number
Description
4.1
Form
of Warrants to Purchase Common Stock issued in 2012 and 2013 in connection with Relmada Therapeutics, Inc. Series A Preferred Stock
(incorporated by reference to Exhibit 4.1 of Relmada’s Form 8-K filed with the SEC on May 27, 2014).
4.2
Form
of Warrants to Purchase Common Stock issued in 2012 and 2013 in connection with Relmada Therapeutics, Inc. 8% Senior Subordinated
Promissory Notes (incorporated by reference to Exhibit 4.2 of Relmada’s Form 8-K filed with the SEC on May 27, 2014).
4.3
Form
of B Warrant dated May __, 2014 issued to investors by Relmada Therapeutics, Inc. (incorporated by reference to Exhibit 4.4 of Relmada’s
Form 8-K filed with the SEC on May 27, 2014).
4.4
Form
of B Warrant dated June 10, 2014 issued to investors by Camp Nine, Inc. (incorporated by reference to Exhibit 4.2 of Relmada’s
Form 8-K filed with the SEC on June 16, 2014).
4.5
Form
of Convertible Promissory Note (incorporated by reference to Exhibit 4.1 of Relmada’s Form 10-Q filed with the SEC on February
12, 2018).
4.6
Form
of Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.2 of Relmada’s Form 10-Q filed with the SEC on
February 12, 2018).
4.7
Form
of 2018 Warrant (incorporated by reference to Exhibit 4.1 of Relmada’s Form 10-Q filed with the SEC on November 13, 2018).
4.8
Form
of 2019 Warrant (incorporated by reference to Exhibit 4.1 of Relmada’s Form 10-Q filed with the SEC on May 15, 2019).
4.9
Form
of Exchanged Warrant [(incorporated by reference to Exhibit 4.1 of Relmada’s Form 8-K filed with the SEC on September 22, 2022).]
4.10
Description
of Securities (incorporated by reference to the description of the Company’s common stock, par value $0.001 per share, under
the heading “Description of Securities We May Offer—Authorized Capital Stock; Issued and Outstanding Capital Stock,”
“—Common Stock,” “—Forum for Adjudication of Disputes, “—Anti-takeover Effects of Our Articles
of Incorporation and By-laws, and “—Anti-takeover Effects of Nevada Law” in the Company’s Registration Statement
on Form S-3 (File No. 333-245054), filed with the Securities and Exchange Commission on August 12, 2020)
10.1
Agreement
and Plan of Merger dated as of December 31, 2013 between Relmada Therapeutics, Inc. and Medeor, Inc. (incorporated by reference to
Exhibit 10.1 of Relmada’s Form 8-K filed with the SEC on May 27, 2014).
10.2
2014
Stock Option and Equity Incentive Plan (incorporated by reference to Exhibit 10.14 of Relmada’s Form S-1/A filed with the SEC
on December 9, 2014)
10.3
Director
Agreement, dated July 14, 2015, by and between Charles J. Casamento and Relmada Therapeutics, Inc. (incorporated by reference to
Exhibit 10.1 of Relmada’s Form 8-K filed with the SEC on July 16, 2015)
10.4
Director
Indemnity Agreement, dated July 14, 2015, by and between Charles J. Casamento and Relmada Therapeutics, Inc. (incorporated by reference
to Exhibit 10.2 of Relmada’s Form 8-K filed with the SEC on July 16, 2015)
10.5
Amended
2014 Stock Option and Equity Incentive Plan (incorporated by reference to Exhibit 10.1 of Relmada’s Form 8-K filed with the
SEC on August 7, 2015).
10.6
Form
of Indemnification Agreement (incorporated by reference to Exhibit 10.2 of Relmada’s Form 8-K filed with the SEC on August
7, 2015).
51
Exhibit
Number
Description
10.7
License
Agreement, dated January 16, 2018, between Relmada Therapeutics, Inc. Dr. Charles E. Inturrisi and Dr. Paolo Manfredi (incorporated
by reference to Exhibit 10.1 of Relmada’s Form 8-K filed with the SEC on January 19, 2018).
10.8
Intellectual
Property Assignment Agreement, dated January 16, 2018, between Relmada Therapeutics, Inc. Dr. Charles E. Inturrisi and Dr. Paolo
Manfredi (incorporated by reference to Exhibit 10.2 of Relmada’s Form 8-K filed with the SEC on January 19, 2018).
10.9
Form
of Note and Warrant Purchase Agreement (incorporated by reference to Exhibit 10.1 of Relmada’s Form 10-Q filed with the SEC
on February 12, 2018).
10.10
Third
Amendment to the 2014 Stock Option and Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.3 of Relmada’s
Form 10-Q filed with the SEC on May 14, 2018).
10.11
Form
of Unit Purchase Agreement among Relmada Therapeutics, Inc. and certain accredited investors (incorporated by reference to Exhibit
10.1 of Relmada’s Form 10-Q filed with the SEC on November 13, 2018).
10.12
Amendment
No. 4 to the Relmada Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan, as amended (incorporated by reference to
Exhibit 10.1 of Relmada’s Form 10-Q filed with the SEC on May 15, 2019).
10.13
Form
of Share Purchase Agreement, dated September 23, 2019 and September 26, 2019, among Relmada Therapeutics, Inc. and certain accredited
investors named therein (incorporated by reference to Exhibit 10.4 of Relmada’s Form 10-Q filed with the SEC on November 13,
2019).
10.14
Form
of Registration Rights Agreement, dated September 23, 2019 and September 26, 2019, among Relmada Therapeutics, Inc. and certain accredited
investors named therein (incorporated by reference to Exhibit 10.5 of Relmada’s Form 10-Q filed with the SEC on November 13,
2019).
10.15
Amended
and Restated Unit Purchase Agreement dated November 27, 2019, between Relmada Therapeutics, Inc., and certain accredited investors
(incorporated by reference to Exhibit 10.1 of Relmada’s Form 8-K filed with the SEC on December 3, 2019).
10.16
Amendment
No. 1 To License Agreement dated December 2, 2019, to the License Agreement dated January 16, 2018 between Relmada Therapeutics,
Inc., and Dr. Charles E. Inturrisi and Dr. Paolo Manfredi (incorporated by reference to Exhibit 10.2 of Relmada’s Form 8-K
filed with the SEC on December 3, 2019).
10.17
Director
Agreement, effective December 19, 2019, by and between Eric Schmidt and Relmada Therapeutics, Inc. (incorporated by reference to
Exhibit 10.1 of Relmada’s Form 8-K filed with the SEC on December 26, 2019).
10.18
Indemnity
Agreement, effective December 19, 2019, by and between Eric Schmidt and Relmada Therapeutics, Inc. (incorporated by reference to
Exhibit 10.2 of Relmada’s Form 8-K filed with the SEC on December 26, 2019).
10.19
Director
Agreement, effective December 19, 2019, by and between John Glasspool and Relmada Therapeutics, Inc. (incorporated by reference to
Exhibit 10.3 of Relmada’s Form 8-K filed with the SEC on December 26, 2019).
52
Exhibit
Number
Description
10.20
Indemnity
Agreement, effective December 19, 2019, by and between John Glasspool and Relmada Therapeutics, Inc. (incorporated by reference to
Exhibit 10.4 of Relmada’s Form 8-K filed with the SEC on December 26, 2019).
10.21
Employment
Agreement, dated January 9, 2020, by and between Maged Shenouda and Relmada Therapeutics, Inc. (incorporated by reference to Exhibit
10.1 of Relmada’s Form 8-K filed with the SEC on January 10, 2020).
10.22
Employment
Agreement, dated January 9, 2020, by and between Charles Ence and Relmada Therapeutics, Inc. (incorporated by reference to Exhibit
10.2 of Relmada’s Form 8-K filed with the SEC on January 10, 2020).
10.23
Amended
and Restated Employment Agreement, dated January 9, 2020, by and between Sergio Traversa and Relmada Therapeutics, Inc. (incorporated
by reference to Exhibit 10.3 of Relmada’s Form 8-K filed with the SEC on January 10, 2020).
10.24
Amendment
No. 5 to Stock Option and Equity incentive Plan (incorporated by reference to Exhibit 10.1 of Relmada’s Form 8-K filed with
the SEC on March 9, 2020).
10.25
Open
Market Sale Agreement SM dated as of May 15, 2020 by and between Relmada Therapeutics, Inc. and Jefferies LLC. (incorporated
by reference to Exhibit 10.7 of Relmada’s Form 10-Q filed with the SEC on May 15, 2020).
10.26
Relmada
Therapeutics, Inc., 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.61 of Relmada’s Form 10-K filed with
the SEC on March 24, 2021).
10.27
License
Agreement dated as of July 16, 2021, between Arbormentis, LLC and Relmada Therapeutics, Inc. (incorporated by reference to Exhibit
10.2 of Relmada’s Form 10-Q filed with the SEC on August 10, 2021).
10.28
Exchange
Agreement between Relmada Therapeutics, Inc., and Venrock Healthcare Capital Partners EG, L.P., Venrock Healthcare Capital Partners
II, L.P., VHCP Co-Investment Holdings II, LLC, Venrock Healthcare Capital Partners III, L.P., and VHCP Co-Investment Holdings III,
LLC, dated September 21, 2022 (incorporated by reference to Exhibit 10.1 of Relmada’s Form 8-K filed with the SEC on September
22, 2022).
53
Exhibit
Number
Description
10.29
Amendment
No. 2 dated December 27, 2022, to the License Agreement originally dated January 16, 2018, as heretofore amended, between Relmada
Therapeutics, Inc., and Dr. Charles E. Inturrisi and Dr. Paolo Manfredi (incorporated by reference to Exhibit 10.1 of Relmada’s
Form 8-K filed with the SEC on December 28, 2022).
10.30
Advisory
Agreement dated as of January 1, 2023, between Relmada Therapeutics, Inc., and Paul Kelly (incorporated by reference to Exhibit 10.1
of Relmada’s Form 8-K filed with the SEC on January 5, 2023).
10.31
Director
Agreement between Relmada Therapeutics, Inc., and Fabiana Fedeli (incorporated by reference to Exhibit 99.1 of Relmada’s Form
8-K filed with the SEC on January 17, 2023).
10.32
Indemnity
Agreement between Relmada Therapeutics, Inc., and Fabiana Fedeli (incorporated by reference to Exhibit 99.2 of Relmada’s Form
8-K filed with the SEC on January 17, 2023).
10.33
Employment
Agreement, dated January 1, 2025, between Relmada Therapeutics, Inc. and Paul Kelly (incorporated by reference to Exhibit 10.1 of
Relmada’s Form 8-K filed with the SEC on January 6, 2025).
10.34
Amended
and Restated Employment Agreement, dated January 1, 2025, by and between Sergio Traversa and Relmada Therapeutics, Inc. (incorporated
by reference to Exhibit 10.2 of Relmada’s Form 8-K filed with the SEC on January 6, 2025).
10.35
Amended
and Restated Employment Agreement, dated January 1, 2025, by and between Maged Shenouda and Relmada
Therapeutics, Inc. (incorporated by reference to Exhibit 10.3 of Relmada’s Form 8-K filed with the SEC on January 6,
2025).
10.36
Amended
and Restated Employment Agreement, dated January 1, 2025, by and between Charles Ence and Relmada Therapeutics, Inc. (incorporated
by reference to Exhibit 10.4 of Relmada’s Form 8-K filed with the SEC on January 6, 2025).
10.37
Retention
Compensation Agreement, effective as of August 27, 2024, between Relmada Therapeutics, Inc. and Sergio Traversa (incorporated by
reference to Exhibit 10.5 of Relmada’s Form 8-K filed with the SEC on January 6, 2025).
10.38
Retention
Compensation Agreement, effective as of August 27, 2024, between Relmada Therapeutics, Inc. and Maged Shenouda (incorporated by reference
to Exhibit 10.6 of Relmada’s Form 8-K filed with the SEC on January 6, 2025).
10.39
Retention
Compensation Agreement, effective as of August 27, 2024, between Relmada Therapeutics, Inc. and Charles Ence (incorporated by reference
to Exhibit 10.7 of Relmada’s Form 8-K filed with the SEC on January 6, 2025).
10.40
Retention
Compensation Agreement, effective as of August 27, 2024, between Relmada Therapeutics, Inc. and Paul Kelly (incorporated by reference
to Exhibit 10.8 of Relmada’s Form 8-K filed with the SEC on January 6, 2025).
10.41
Asset
Purchase Agreement between Relmada Therapeutics, Inc. and Asarina Pharma AB, dated February 3, 2025 (incorporated by reference to
Exhibit 10.1 of Relmada’s Form 8-K filed with the SEC on February 6, 2025)
19.1*
Insider Trading Policy, effective November 10, 2020.
54
Exhibit
Number
Description
21.1
List
of Subsidiaries (incorporated by reference to Exhibit 21.1 of Relmada’s Form 10-K filed with the SEC on September 9, 2014).
23.1*
Consent
of Marcum LLP
31.1*
Certification
of Principal Executive Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
31.2*
Certification
of Principal Financial and Accounting Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
32.1†
Certification
of Principal Executive Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
32.2†
Certification
of Principal Financial and Accounting Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
97.1*
Clawback Policy, effective November 21, 2023.
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).
* Filed
herewith
† Furnished herewith
ITEM 16. FORM 10-K SUMMARY
None.
55
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, this report has been signed below by the following person on behalf of the Registrant.
Dated: March 27, 2025
RELMADA THERAPEUTICS, INC.
By:
/s/
Sergio Traversa
Sergio Traversa
Chief Executive Officer
(Duly Authorized Officer and
Principal Executive Officer)
By:
/s/
Maged Shenouda
Maged Shenouda
Chief Financial Officer
(Duly Authorized Officer and
(Principal Financial and Accounting Officer)
Pursuant to the requirements of the Securities
Exchange Act of 1934, this report has been signed below by the following person on behalf of the Registrant and in the capacities and
on the dates indicated.
Signature
Title
Date
/s/ Sergio Traversa
Chief Executive Officer, and Director
March 27, 2025
Sergio Traversa
/s/ Maged Shenouda
Chief Financial Officer
March 27, 2025
Maged Shenouda
/s/ Charles J. Casamento
Chairman of the Board
March 27, 2025
Charles J. Casamento
/s/ Paul Kelly
Director
March 27, 2025
Paul Kelly
/s/ John Glasspool
Director
March 27, 2025
John Glasspool
/s/ Fabiana Fedeli
Director
March 27, 2025
Fabiana Fedeli
56