UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2024
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _______________to _______________
Commission
file number 001-41765
Telomir
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Florida
87-2606031
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
900
W Platt Street , Suite 200
Tampa ,
Florida
33606
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number (including area code):
(813)
864-2558
Not
Applicable
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class:
Trading
symbol
Name
of each exchange on which registered
Common
Stock, no par value
TELO
The
Nasdaq Capital Market
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes
☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer or a smaller reporting
company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 13, 2024, there were 29,609,814 shares of company common stock issued and outstanding.
TELOMIR
PHARMACEUTICALS, INC.
Quarterly
Report on Form 10-Q
TABLE
OF CONTENTS
Page
Part
I. Financial Information
Item
1.
Condensed Financial Statements (unaudited)
Condensed Balance Sheets as of June 30, 2024 and December 31, 2023
3
Condensed Statements of Operations for the three and six months ended June 30, 2024 and 2023
4
Condensed Statements of Stockholders’ Equity (Deficit) for the three and six months ended June 30, 2024 and June 30, 2023
5
Condensed Statements of Cash Flows for the six months ended June 30, 2024 and 2023
6
Notes to Condensed Financial Statements
7
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
12
Item
3.
Quantitative and Qualitative Disclosures about Market Risk
16
Item
4.
Controls and Procedures
16
Cautionary Note on Forward Looking Statements
17
Part II. Other Information
18
Item
1
Legal Proceedings
18
Item
1A.
Risk Factors
18
Item
2
Unregistered Sales of Equity Securities and Use of Proceeds
18
Item
3
Defaults upon Senior Securities
18
Item
4
Mine Safety Disclosures
18
Item
5
Other Information
19
Item
6.
Exhibits
21
Signatures
22
2
TELOMIR
PHARMACEUTICALS, INC.
CONDENSED
BALANCE SHEETS
AS
OF JUNE 30, 2024 AND DECEMBER 31, 2023
June 30,
December 31,
2024
(unaudited)
2023
ASSETS
Current assets:
Cash
$ 1,883,909
$ 1,231
Deferred offering costs
-
303,281
Prepaid expenses
87,813
713
Due from related parties
130,000
130,000
Total current assets
2,101,722
435,225
Deferred Financing Costs
-
4,338,543
Total assets
$ 2,101,722
$ 4,773,768
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Trade accounts payable and accrued liabilities
$ 393,814
$ 707,187
Due to related parties
140,341
527,377
Related party line of credit
-
101,000
Total current liabilities
534,155
1,335,564
Total liabilities
534,155
1,335,564
Stockholders’ Equity
Preferred Stock, no par value, 100,000,000 shares authorized and none issued or outstanding.
-
-
Common Stock, no par value; 300,000,000 shares authorized, 29,609,814 and 28,609,814 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively.
-
-
Additional paid-in capital
23,335,319
17,502,346
Accumulated deficit
( 21,767,752 )
( 14,064,142 )
Total stockholders’ equity
1,567,567
3,438,204
Total liabilities and stockholders’ equity
$ 2,101,722
$ 4,773,768
See
notes to condensed financial statements
3
TELOMIR
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF OPERATIONS
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
2024
2023
2024
2023
Three Months Ended June 30,
Six Months Ended June 30,
2024
2023
2024
2023
Revenues
$ -
$ -
$ -
$ -
Operating costs:
General and administrative expenses
879,695
60,107
1,621,237
102,710
Related party travel costs
-
698,600
370,500
698,600
Research and development expenses
594,801
667,626
1,398,824
1,107,960
Total operating costs
1,474,496
1,426,333
3,390,561
1,909,270
Interest income
25,493
-
25,493
-
Interest expense
-
( 124,052 )
( 4,338,542 )
( 124,052 )
Net loss
$ ( 1,449,003 )
$ ( 1,550,385 )
$ ( 7,703,610 )
$ ( 2,033,322 )
Basic and diluted loss per share
$ ( 0.05 )
$ ( 0.06 )
$ ( 0.26 )
$ ( 0.08 )
Weighted average common stock shares outstanding
29,609,814
27,097,294
29,443,148
27,023,440
See
notes to condensed financial statements
4
TELOMIR
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2024 AND JUNE 30, 2023
(Unaudited)
Shares
Amount
Capital
Deficit
Equity
Common Stock
Additional Paid-In
Accumulated
Total
Stockholders’ (Deficit)
Shares
Amount
Capital
Deficit
Equity
Balances, January 1, 2024
28,609,814
$ -
$ 17,502,346
$ ( 14,064,142 )
$ 3,438,204
Issuance of common stock at IPO, net
1,000,000
-
5,832,973
-
5,832,973
Net loss
-
-
-
( 7,703,610 )
( 7,703,610 )
Balances, June 30, 2024
29,609,814
$ -
$ 23,335,319
$ ( 21,767,752 )
$ 1,567,567
Balances, January 1, 2023
26,829,269
$ -
$ 55,000
$ ( 992,278 )
$ ( 937,278 )
Issuance of common stock, net
268,025
-
910,000
-
910,000
Issuance of Warrants
-
-
5,950,000
-
5,950,000
Net loss
-
-
-
( 2,033,322 )
( 2,033,322 )
Balances, June 30, 2023
27,097,294
$ -
$ 6,915,000
$ ( 3,025,600 )
$ 3,889,400
Common Stock
Additional Paid-In
Accumulated
Total
Stockholders’ (Deficit)
Shares
Amount
Capital
Deficit
Equity
Balances, March 31, 2024
29,609,814
$ -
$ 23,335,319
$ ( 20,318,749 )
$ 3,016,570
Net loss
-
-
-
( 1,449,003 )
( 1,449,003 )
Balances, June 30, 2024
29,609,814
$ -
$ 23,335,319
$ ( 21,767,752 )
$ 1,567,567
Balances, March 31, 2023
27,097,294
$ -
$ 965,000
$ ( 1,475,215 )
$ ( 510,215 )
Balances
27,097,294
$ -
$ 965,000
$ ( 1,475,215 )
$ ( 510,215 )
Issuance of Warrants
-
-
5,950,000
-
5,950,000
Net loss
-
-
-
( 1,550,385 )
( 1,550,385 )
Balances, June 30, 2023
27,097,294
$ -
$ 6,915,000
$ ( 3,025,600 )
$ 3,889,400
Balances
27,097,294
$ -
$ 6,915,000
$ ( 3,025,600 )
$ 3,889,400
See
notes to condensed financial statements
5
TELOMIR
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF CASH FLOWS
FOR
THE SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
2024
2023
Six Months Ended June 30,
2024
2023
Cash flows from Operating activities
Net loss
$ ( 7,703,610 )
$ ( 2,033,322 )
Adjustments to reconcile net loss to net cash from operations
Non-cash interest expense
-
94
Amortization of debt issuance costs
4,338,543
123,958
Change in operating assets and liabilities:
Trade accounts payable and accrued liabilities
( 10,091 )
1,139,954
Prepaid expenses
( 87,100 )
-
Net cash flows from operating activities
$ ( 3,462,258 )
$ ( 769,316 )
Financing activities:
Payment of deferred offering costs
-
( 34,126 )
Payments under related party line of credit
( 101,000 )
-
Payments to related party
( 519,475 )
( 581,262 )
Borrowings from related party
132,438
-
Borrowings under related party line of credit
-
487,914
Proceeds from sale of common stock, less offering costs
5,832,973
910,000
Net cash flows provided by financing activities
5,344,936
782,526
Net change in cash
1,882,678
13,210
Cash, beginning of period
1,231
1,419
Cash, end of period
$ 1,883,909
$ 14,629
Cash paid for interest
-
-
Supplemental schedule of non-cash financing activities:
Accrued offering expense
$ -
$ 124,126
Issuance of warrants on related party line of credit
-
5,950,000
SUPPLEMENTAL
CASH FLOW INFORMATION
Non-cash
Operating, Financing and Investing Activities:
The
Company accrued $ 0.1 million in legal and placement fees related to a $ 1.0 million private placement offering during the six months ended
June 30, 2023, whereby 268,025 shares of common stock were issued.
The
Company recorded the fair value of a total of 2,439,025 warrants issued to Bay Shore Trust during the six months ended June 30, 2023
totaling approximately $ 5.95 million to deferred finance costs
See notes to condensed financial statements
6
TELOMIR
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
Note
1. Description of business and summary of significant accounting policies :
Overview
Telomir
Pharmaceuticals, Inc. (“Telomir” or the “Company”) was formed in August 2021 and is a Florida-based early
pre-clinical stage biopharmaceutical company that is developing its product candidate, TELOMIR-1, the first novel small molecule
designed to lengthen the DNA’s protective telomere caps. TELOMIR-1 potentially will promote longevity in humans and canine
animals by treating age-related conditions. Telomeres, the protective end caps of chromosomes composed of DNA sequences and
proteins, naturally shorten as humans age. This shortening is accelerated by metal reactivity, which increases the risk of
degenerative and age-related diseases.
As such TELOMIR-1 is undergoing studies to potentially provide a therapeutic intervention against contracting a number of degenerative
and age-related diseases. Telomir’s goal is to develop and commercialize TELOMIR-1, proposed to be dosed orally, with the broader
aim of promoting longevity and enhancing overall quality of life.
Substantive
operations began in late 2022 and the Company’s Investigative New Drug application is anticipated to be filed with the U.S. Food
and Drug Administration (“FDA”) in first half of 2025. National phase filings are expected to be made
during the first quarter 2025. See Note 3 regarding this patent.
The
accounting and reporting policies of the Company conform to accounting principles generally accepted in the United States of America
(“GAAP”). In the opinion of management, all adjustments considered necessary for the fair presentation of the financial statements
for the periods presented have been included. The results of operations for the six months ended June 30, 2024 are not necessarily indicative
of the results to be expected for future periods.
As
used herein, the Company’s Common Stock, no par value per share, is referred to as the “Common Stock” and the
Company’s preferred stock, no par value per share, is referred to as the “Preferred Stock”.
Initial
Public Offering
On
February 13, 2024, the Company closed its initial public offering consisting of 1,000,000 shares at a price of $ 7.00 per share for approximately
$ 7.0 million in gross proceeds. After deducting the underwriting commission and other offering expenses totaling $ 1.2 million, the net
proceeds to the Company were $ 5.8 million (the “IPO”). The common stock began trading on The Nasdaq Capital Market on February
9, 2024 under the symbol “TELO”.
Significant
Accounting Policies
There
have been no material changes in the Company’s significant accounting policies from those previously disclosed in the Company’s
2023 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the Securities and Exchange Commission
on March 29, 2024.
Note
2. Liquidity and capital resources
As
of June 30, 2024, the Company had cash of approximately $ 1.9 million. The Company used approximately
$ 3.5 million of cash in operations during the six months ended June 30, 2024.
7
Historically,
the Company has been primarily engaged in developing TELOMIR-1. During these activities, the Company sustained substantial losses. The
Company’s ability to fund ongoing operations and future clinical trials required for FDA approval is dependent on the Company’s
ability to obtain significant additional external funding in the near term. Since inception, the Company has financed its operations
through related party financings and an initial public offering. Additional sources of financing may be sought by the Company. However,
there can be no assurance that any fundraising will be achieved on commercially reasonable terms, if at all.
As
of the date of filing, the Company will continue to generate losses and have insufficient cash and cash equivalents on hand to support
its operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial
doubt about the Company’s ability to continue as a going concern through 12 months after the date the financial statements are
issued.
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of
recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue
as a going concern
Note
3. License agreement, related party :
The
Company licenses the U.S. patent rights for the use of TELOMIR-1 in human applications from MIRALOGX, LLC (“MIRALOGX”), an
intellectual property development and holding company established by a significant shareholder of the Company.
On
August 11, 2023, (the “Effective Date”), the Company and MIRALOGX entered into an Amended and Restated Exclusive License
Agreement, under which the Company has the exclusive perpetual right and license under the above-described patent rights to make, have
made, use, and sell “Licensed Products” in the U.S. for human uses and preclinical studies and activities of any kind conducted
in furtherance of obtaining regulatory approval or commercialization for human uses (the “MIRALOGX License Agreement”). On
November 10, 2023, we and MIRALOGX entered into the Amendment No. 1 to the Amended and Restated License Agreement, pursuant to which
the field of use relating to the license was amended to include therapeutic treatments and other medical or health uses in animals, in
addition to humans, and related preclinical studies and activities conducted in furtherance of obtaining regulatory approval for and
commercialization of veterinary, in addition to human, therapeutic treatments and uses (together with the “Initial MIRALOGX License
Agreement, the “MIRALOGX License Agreement”). “Licensed Product” is defined in the agreement as a drug product
containing as an active agent 2,4,6-tris(3,4-dihydro-2H-pyrrol-2-yl) pyridine or a pharmaceutically acceptable salt, ester, or solvate
thereof. We also have the right to grant corresponding sublicenses under the licensed patent rights. The MIRALOGX License Agreement provides
for the payment to MIRALOGX of an 8 % royalty (payable quarterly) on the Company’s net sales of Licensed Products by the Company
or its sublicensees and on non-royalty bearing milestone revenue. There are no up-front, execution, or milestone payments in the license
agreement. Further, no payments have been made to date under the agreement.
The
term of the license from MIRALOGX will continue through the date of the expiration of the last-to-expire licensed patent or, if later,
the date of the expiration of the last strategic partnership/sublicensing agreement covering the licensed products. The patent rights
are expected to extend through 2043, and additional patent terms may be awarded, including additional patent terms based on the time
taken for regulatory review of drug products.
The
agreement also provides that the Company may bring suit in its own name to enforce patent rights. MIRALOGX will control the prosecution
of the patent applications for TELOMIR-1. The Company is required to be kept informed by MIRALOGX of patent prosecution activities and
may select identified countries for patent protection. The Company is to reimburse MIRALOGX for patent prosecution and maintenance costs.
Note
4. Related party transactions :
Due
from related parties- Amounts due from related parties as of both June 30, 2024 and December 31, 2023 totaled $ 0.13 million. These
advances are due on demand and are non-interest bearing.
8
Due
to related parties- During the periods ended June 30, 2024 and December 31, 2023, the Company received working capital advances from
companies under common control. These advances are due on demand and are non-interest bearing. During the year ended December 31, 2023,
advances in the amount of $ 1.7 million were converted into 837,841 shares of our common stock at a conversion rate of $ 2.05 per share
resulting in a loss on the conversion of debt of $ 4.1 million. As of June 30, 2024 and December 31, 2023, $ 0.14 million and $ 0.5 million,
respectively, advances remained outstanding.
Shared
management- Historically, the Company has shared management with related parties on an as-needed basis, to collaborate and pool resources
efficiently. For the six months ended June 30, 2024, the Company incurred $ 0.010 million in costs related to this arrangement which is
recorded in general and administrative expenses.
Bay
Shore Trust Line of Credit
On
June 15, 2023, the Company entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, which was established by a
significant shareholder of the Company. Under this Promissory Note and Loan Agreement (the “Bay Shore Note”), the
Company had the right to borrow up to an aggregate of $ 5
million from the Bay Shore Trust at any time up to the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon
the completion of the Company’s IPO. The Company’s right to borrow funds under the Bay Shore Note was subject to the
absence of a material adverse change in its assets, operations, or prospects. The Bay Share Note, together with accrued interest,
was to become due and payable on the second anniversary of the issuance of the note, provided prepayment at any time without
penalty. The Bay Shore Note accrued interest at a rate equal 7 %
per annum, simple interest, during the first year that the note is outstanding and 10 %
per annum, simple interest, thereafter. The Bay Shore Note was unsecured.
In
consideration of the loan facility provided by the Bay Shore Trust, the Company issued to the Bay Shore Trust a common stock purchase
warrant on June 15, 2023 giving the Bay Shore Trust the right to purchase up to 2,439,025 shares of common stock at an exercise price
of $ 3.73 per share, which warrant will expire five years after the date of grant. Pursuant to a registration rights agreement, the Company
has granted to Bay Shore Trust the right to require the Company, at any time after one year following the Company’s IPO, to register
for resale the shares issuable upon the exercise of the warrant, with such registration rights being in the form of demand and “piggyback”
registration rights that are subject to customary limitations and restrictions. As of June 30, 2024, these shares have not
been registered. Upon issuance, the warrant met the criteria to be classified as equity based on an analysis under Accounting Standards
Codification (480) ASC 480, “Distinguishing Liabilities from Equity” and was measured at fair value, resulting in an initial
fair value of approximately $ 5.95 million upon issuance of the warrant, using Black-Scholes valuation techniques.
The
borrowings from Bay Shore Trust were paid in full during the three months ended March 31, 2024, and the Company has fully amortized the
relating financing costs and future borrowings are no longer available due to the terms of the agreement, specifically the closing of
the Company’s IPO, which was made effective on February 13, 2024.
License
agreement - See Note 3.
Related
Party Travel Costs- On April 1, 2023 the Company entered into an Agreement For Shared Lease Costs (the “Shared Agreement”)
with MIRALOGX, LLC, a related party. Under the Shared Agreement, the Company agrees to make monthly contributions or payments in accordance
with its use of shared aircraft toward rent payments. During the six months ended June 30, 2024 and June 30, 2023, the Company incurred
$ 0.4 million and $ 0.7 million, respectively, for travel-related expenses to the related party for rental charges and airplane-related
expenses.
Related
Party Rental Agreement- see Note 5 for Variable Lease
Note
5. Leases :
The
Company’s former corporate headquarters was located in Baltimore, Maryland, which included a lease for office space. This lease
began in November 2022 and expired in April 2024. The lease was not renewed.
9
The
Company moved all corporate headquarter related activities in April 2024 to the shared space in Tampa, Florida referenced below within
variable lease costs.
Variable
lease costs
Variable
lease costs primarily include utilities, property taxes, and other operating costs that are passed on from the lessor. Variable lease
costs related to the aircraft include usage expenses, which includes pilot expenses, jet fuel and general flight expenses.
Beginning
August 1, 2023, the Company’s accounting and administrative staff began sharing office space with a related party in Tampa, Florida.
As of June 30, 2024, there is no formal agreement, pending a revised lease agreement from the landlord. As such, the Company has agreed
to split the cost of the Tampa lease pending an executed lease. During the six months ended June 30, 2024, this variable lease cost related
to the Tampa, Florida space totaled $ 0.012 million which is recorded in general and administrative expenses.
Schedule
of Components of Lease Expenses
2024
2023
Six Months ended June 30,
2024
2023
Lease Costs
Operating lease
$ 55,667
$ 3,708
Variable lease costs
332,636
698,600
Total lease cost
$ 388,303
$ 702,308
Note
6. Stockholders’ equity :
Capital
stock
The
Company has the authority to issue 400,000,000 shares of capital stock, consisting of 300,000,000 shares of Common Stock and 100,000,000
shares of undesignated preferred stock, whose rights and privileges will be defined by the Board of Directors when a series of preferred
stock is designated.
Warrants
The
Company has granted warrants to purchase shares of Common Stock. Warrants may be granted to affiliates in connection with certain agreements.
As
of June 30, 2024, a cumulative total of 2,824,057 warrants, with exercise prices ranging from $ 3.73 to $ 15.42 remain exercisable and
outstanding. There were no warrants exercised during the six months ended June 30, 2024.
Underwriter
warrants
In
connection with the IPO, the Company issued 50,000 warrants to purchase common stock to the IPO underwriter (or its designees) at an
exercise price of $ 7.00 which expire after a four-and-a-half-year period commencing six months after the commencement of sales in the
IPO. The warrants will be exercisable at any time and from time to time, in whole or in part, during the four-and-a-half-year period
commencing six months after the commencement of sales in the IPO. The warrants provide for registration rights (including a one-time
demand registration right and piggyback registration rights that expire 5 years from the commencement of sales of the offering) and customary
anti-dilution provisions
Earnings
Per Share
During
the three and six months ended June 30, 2024 and 2023, outstanding stock warrants of 2,824,057 and 2,774,057 , respectively, were not
included in the computation of diluted earnings per share, because to do so would have had an antidilutive effect.
10
Note
7 – Subsequent events :
Passing
of Dr. Christopher Chapman
On
August 8, 2024, the Company was made aware of the passing of its Chairman and Chief Executive Officer, Dr. Christopher Chapman.
Restructuring of the Board
of Directors
On
August 8, 2024, Ms. Talhia Tuck, Mr. Brad Kroenig and Mr. Hugh McColl, each voluntarily resigned from the Board, effective immediately
(the “Board Resignations”). Subsequent thereto, the remaining members of the Board appointed new members of the Board, as
discussed below. The resignations of Ms. Tuck, Mr. Kroenig, and Mr. McColl were not the result of any disagreement with the Company on
any matter relating to its operations, policies or practices.
On
August 8, 2024, the remaining members of the Board (Dr. Craig Eagle, M.D. and Michael Jerman) unanimously approved the appointment
of Mr. Erez Aminov, Dr. Matthew P. Del Giudice, Mr. Matthew Pratt Whalen and Mr. Ned MacPherson as members of the Board, to fill the
vacancies on the Board occasioned by the Board Resignations and the passing of Dr. Chapman, for a term expiring at the Company’s
2024 annual meeting of stockholders.
The
following is certain biographical information regarding Dr. Del Giudice and Messrs. Aminov, Whalen and MacPherson:
Erez
Aminov , age 46, has served as a director and Chief Executive Officer of MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA), a preclinical-stage
pharmaceutical company focused on the development and commercialization of a new molecular synthetic cannabinoid analog for the treatment
of adult patients with neuropathic pain as well as anxiety and cognitive decline typically associated with early-stage dementia, since
April 2023 and its Chairman since March 2024. In this role, Mr. Aminov leads the development and commercialization of MIRA’s lead
candidate. Mr. Aminov’s experience in the biotech consulting sector began in 2021 when he founded Locate Venture Corp. in September
2021. Locate Venture is a strategy and investment consulting firm focused on advancing and supporting early-stage biotech startups.
Prior to founding Locate Venture Corp., from February 2015 to September 2020, Mr. Aminov served as the President of Finds4less Inc.,
a global distributor of electronics and gaming products. In this role, Mr. Aminov provided strategic oversight and direction for all
aspects of the company’s operations, while also spearheading new business development initiatives to capitalize on emerging market
opportunities. Mr. Aminov’s more than two decades of experience includes experience with the biotech industry’s particular
challenges, including creating strategic alliances and guiding startups toward growth and prosperity. Mr. Aminov earned a B.A. in Accounting
from Touro University in New York. We believe that Mr. Aminov is qualified to serve as one of our directors based on his finance and
investment experience, particularly with early-stage life sciences companies.
Dr.
Matthew P. Del Giudice , age 42, has practiced as a radiologist since 2014. He currently serves as a general overnight emergency radiologist
at the Cleveland Clinic. Since March 2024, he has also served as a director of
MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA). Prior to joining the Cleveland Clinic, from March 2021 to May 2022, Dr. Del Giudice was a
general radiologist with Radiology and Imaging Specialists in Phoenix, Arizona. From July 2015 to February 2021, Dr. Del Giudice was
a radiologist with Radiology Partners Phoenix, and from July 2014 to June 2015, he practiced as a musculoskeletal radiologist at the
University of Arizona Health Sciences Center – Tucson. Dr. Del Giudice received his B.S. from the University of Illinois at Urbana-Champaign,
his M.D. from Loyola University Stritch School of Medicine, completed his radiology residency at Loyola University Medical Center, and
his musculoskeletal radiology fellowship at the University of Arizona Health Sciences Center – Tucson. Dr. Del Giudice is licensed
to practice medicine in Florida and Ohio. We believe that Dr. Del Giudice is qualified to serve as one of our directors based on his
extensive experience as a radiologist.
Matthew
Pratt Whalen, CPA, age 45, is a Certified Public Accountant with over two decades of experience in public
accounting and corporate finance. Mr. Whalen currently serves as the Chief Financial Officer of Power Digital Marketing Inc., an
industry leading digital marketing agency, where he has driven significant revenue growth and led key financial transactions.
Specifically, Mr. Whalen oversees the finance team, manages tax and audit relationships, and handles treasury management. Prior to
joining Power Digital, from 2010 to May 2021, Mr. Whalen was the Chief Financial Officer of MRC Smart Technology Solutions, a
subsidiary of Xerox Corporation where he played a pivotal role in growing the company’s revenue and managed diverse teams
across multiple departments. Mr. Whalen holds a B.A. in Accounting from the University of San Diego and is a Certified Public
Accountant in California. Mr. Whalen has also served on the Finance Committee of United Way San Diego. We believe that Mr. Whalen is qualified to serve as one
of our directors based on his extensive experience in finance and as a Certified Public Accountant.
Ned
MacPherson, age 36, currently serves as Chief Growth Officer for Power Digital, an industry leading digital marketing agency.
Since March 2024, he has also served as a director of MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA). Prior to joining Power Digital, from
May 2016 to December 2023, he served as CEO and Head of Growth for Endrock Growth & Analytics, a company he founded and sold to Power
Digital. Prior to founding Endrock Growth & Analytics, Mr. MacPherson held senior marketing and leadership positions at sunglass
maker Prive Revaux (March 2018 to April 2020), curated meal company Menud (October 2014 to April 2018) and Rejuvenetics, LLC, a distributor
of health and wellness products (December 2012 to March 2016). Mr. Macpherson holds a BA in Economics from Gettysburg College. We believe
that Mr. MacPherson is qualified to serve as one of our directors based on his extensive experience assisting growth for early-stage
companies.
On
August 9, 2024, to fill the vacancies left by the passing of Dr. Chapman, the new Board unanimously approved the appointment of Mr. Aminov
as the Company’s Chief Executive Officer and Chairman of the Board. Additionally, the new Board designated the new members of the
Audit, Compensation and Nominating and Corporate Governance Committees in conformance with the rules of the Nasdaq Stock Market. Accordingly,
the new (i) Audit Committee shall consist of Mr. Jerman (Chairman), Mr. Whalen and Mr. Macpherson, (ii) Compensation Committee
shall consist of Dr. Del Giudice (Chairman) and Mr. Macpherson and (iii) Nominating and Corporate Governance Committee shall consist
of Mr. Eagle (Chairman) and Dr. Del Giudice.
Employment
Agreement with Erez Aminov
Effective
August 12, 2024, we entered into an employment agreement with Mr. Aminov, pursuant to which Mr. Aminov will serve as our Chief Executive
Officer and Chairman of our Board. Under his employment agreement, Mr. Aminov has agreed to devote reasonable business time and effort
to the business and affairs of the Company. Mr. Aminov’s employment agreement provides that his employment will be on an at-will
basis and can be terminated by either Mr. Aminov or our company at any time and for any reason. Under the agreement, Mr. Aminov will
receive a base salary of $ 0.275
million per year. In the event that Mr. Aminov’s
employment is terminated by our company without “Cause” or is terminated by Mr. Aminov for “Good Reason”, Mr.
Aminov will be entitled to (1) be paid an amount equal to Mr. Aminov’s annual base salary, which payment shall be made seventy-five
percent (75%) in a lump sum within thirty (30) days following the effective date of the general release of claims (following any revocation
period) and twenty-five percent (25%) as salary continuation payments in substantially equal installments over the six (6) months following
the release effective date in accordance with the Company’s customary payroll practices commencing on the first payroll date following
the release effective date, and (2) receive twelve (12) months’ accelerated vesting of any stock options that are outstanding and
unvested as of such termination, such that any outstanding and unvested stock options that would have vested during the twelve- (12)
month period following the termination date had Mr. Aminov remained employed in good standing shall become immediately vested and exercisable
for a period of three (3) months post-termination (subject to Mr. Aminov executing and delivering a customary general release in favor
of the company). “Cause” is defined in the agreement to include dishonesty, misappropriation, willful misconduct, breach
of the agreement, and other customary matters. “Good Reason” is defined to include a material adverse change in Mr. Aminov’s
compensation or duties and level of responsibility. The employment agreement also contains customary confidentiality and invention-assignment
covenants to which Mr. Aminov is subject.
11
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis should be read in conjunction with the Condensed Financial Statements and Notes thereto included elsewhere
in this Quarterly Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company’s
actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a
result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Quarterly Report and in the Company’s
other filings with the SEC. See “Cautionary Note Regarding Forward Looking Statements” below.
As
used in this Management’s Discussion and Analysis of Financial Condition and Results of Operations, unless otherwise indicated,
the terms “the Company”, “we”, “us”, “our” and similar terminology refer to Telomir Pharmaceuticals,
Inc.
Background
of the Company
We
are a pre-clinical-stage pharmaceutical company focused on the development and commercialization of TELOMIR-1, a novel small molecule
being developed to lengthen the DNA’s protective telomere caps, potentially promoting longevity in humans and canine animals by
treating age-related conditions. Telomeres, the protective end caps of chromosomes composed of DNA sequences and proteins, naturally shorten
as humans age. This shortening is accelerated by metal reactivity, which increases the risk of degenerative and age-related diseases
Our
goal is to advance the clinical development of TELOMIR-1 in the United States for the treatment of age-related inflammatory conditions and commercialize Telomir-1, proposed to be dosed orally, with the broader aim of promoting longevity
and enhancing overall quality of life.
To
date, we have not generated any revenue nor do we expect to generate revenue unless and until we successfully complete preclinical and
clinical development of, receive regulatory approval for, and commercialize a program and we do not know when, or if at all, that will
occur. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical
activities and studies and initiate clinical trials. In addition, if we obtain regulatory approval for any programs, we expect to incur
significant expenses related to production of sales, marketing, and distribution to the extent that such sales, marketing and distribution
are not the responsibility of potential collaborators. We expect to incur additional costs associated with operating as a public company.
Our
operating expenses have historically been the costs associated with our initial investment in pre-clinical research and development activities.
We expect research and development expenses will increase in the future as we advance TELOMIR-1 into and through clinical trials and
pursue regulatory approvals, which will require a significant investment in costs of clinical trials, regulatory support, and contract
manufacturing. In addition, we will evaluate opportunities to acquire or in-license additional product candidates and technologies, which
may result in higher research and development expenses due to license fee and/or milestone payments, as well as added clinical development
costs
We
had net losses of $7.6 million and $2.0 million for the six months ended June 30, 2024 and 2023, respectively.
12
Components
of Our Results of Operations
Research
and development expenses represent costs incurred to conduct research and development of our product candidate. We recognize all research
and development costs as they are incurred. Research and development expenses consist primarily of the following:
●
contracted
research and manufacturing;
●
consulting
arrangements; and
●
other
expenses incurred to advance the Company’s research and development activities.
Our
operating expenses have historically been the costs associated with our initial investment in pre-clinical research and development activities.
We expect research and development expenses will increase in the future as we advance TELOMIR-1 into and through clinical trials and
pursue regulatory approvals, which will require a significant investment in costs of clinical trials, regulatory support, and contract
manufacturing. In addition, we will evaluate opportunities to acquire or in-license additional product candidates and technologies, which
may result in higher research and development expenses due to license fee and/or milestone payments, as well as added clinical development
costs.
The
process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in timely
development and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be
affected by numerous factors, including clinical data, competition, manufacturing capability and commercial viability. As a result, we
are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue
from the commercialization and sale of our product candidates.
Critical
Accounting Policies
See
Note 1 of the Notes to Condensed Financial Statements included in Item 1 of this Quarterly Report for a summary of significant accounting
policies and information on recently issued accounting pronouncements.
Results
of Operations
For
the six months ended June 30 , 2024 compared
to the six months ended June 30, 2023
Research
and Development Expenses. During the six months ended June 30, 2024, we incurred $1.4
million in research and development expenses, which were primarily related to toxicology studies, pre-clinical research projects and
related manufacturing for pre-clinical research projects. We incurred $1.1 million in research and development expenses during the
six months ended June 30, 2023, relating to initial payments for toxicology studies and consulting arrangements. Going forward, we
expect our research and development expenses to generally remain consistent as incurred in 2024. Research and development expenses represent costs
incurred to conduct research and development of our product candidate and consist primarily of contracted pre-clinical
research and manufacturing, toxicology, consulting arrangements and other expenses incurred to advance the Company’s research
and development activities.
General
and Administrative Expenses . We incurred $1.6 million and $0.1 million in general and
administrative expenses during the six months ended June 30, 2024 and June 30, 2023, respectively. The increase is primarily due to
payroll costs for management and consultants that began after the IPO and were not incurred during the six months ended June 30,
2023. Going forward, we expect our general and administrative expenses to generally remain consistent with amounts incurred in 2024. General and administrative
expenses consist of administrative functions, as well as fees paid for legal, consulting fees and facilities costs not otherwise
included in research and development expenses. Legal costs include general corporate legal fees and license costs. We expect to
incur additional expenses as a result of becoming a public company, including expenses related to compliance with the rules and
regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and professional
services.
13
Related
Party Travel Costs . We incurred $0.4 and $0.7 million in related party travel costs during the six months ended June 30, 2024 and
June 30, 2023, respectively. Related party travel costs consisted of a lease and use of an airplane with an entity under common control.
The Company will not participate in the use of the airplane after March of 2024 and, pursuant to
the terms of the Shared Agreement, will not have any further obligation under the agreement.
Interest
expense . We incurred $4.3 million and $0.1 million in interest expenses during the six months ended June 30, 2024 and June 30, 2023,
respectively. The 2024 interest expense consists of the amortization of the deferred financing costs on warrants issued in connection
with the related party line of credit as disclosed in Note 5 to the condensed financial statements.
For
the three months ended June 30 , 2024 compared
to the three months ended June 30, 2023
Research
and Development Expenses. During the three months ended June 30, 2024, we incurred $0.6
million in research and development expenses, which were primarily related to toxicology studies, pre-clinical research projects and
related manufacturing for pre-clinical research projects. We incurred $0.7 million in research and development expenses during the
three months ended June 30, 2023, relating to initial payments for toxicology studies and consulting arrangements. Going forward, we
expect our research and development expenses to generally remain at consistent levels as incurred in 2024. Research and development expenses represent costs
incurred to conduct research and development of our product candidate and consist primarily of contracted pre-clinical research and
manufacturing, toxicology, consulting arrangements and other expenses incurred to advance the Company’s research and
development activities.
General
and Administrative Expenses . We incurred $0.9 million and $0.06 million in general and
administrative expenses during the three months ended June 30, 2024 and June 30, 2023, respectively. The increase is primarily due
to payroll costs for management and consultants that began upon the IPO and were not incurred during the three months ended June
30, 2023. Going forward, we expect our general and administrative expenses to generally remain at consistent levels as incurred in 2024. General and
administrative expenses consist of administrative functions, as well as fees paid for legal, consulting fees and facilities costs
not otherwise included in research and development expenses. Legal costs include general corporate legal fees and license costs. We
expect to incur additional expenses as a result of becoming a public company, including expenses related to compliance with the
rules and regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and
professional services.
Related
Party Travel Costs . We incurred $0.7 million in related party travel costs during the three months ended June 30, 2023. There was
no such expense incurred during the same period ended June 30, 2024. Related party travel costs consisted of a lease and use of an airplane
with an entity under common control. The Company will not participate in the use of the airplane
after March of 2024 and, pursuant to the terms of the Shared Agreement, will not have any further obligation under the agreement.
Interest
income (expense) . We earned $0.025 million in interest income during the three months ended June 30, 2024, and incurred $0.1 million
in interest expense during the three months ended June 30, 2023. The interest income received in the three months ended June 30, 2024
is primarily related to income earned from money market accounts.
Liquidity
and Capital Resources
Sources
of Liquidity
Since
the Company’s inception in August 2021, we have financed our operations primarily through an unsecured line of credit with a major
shareholder and an affiliated company and through a $1.0 million private placement of shares of our common stock that occurred during
the first quarter 2023 at $3.73 per share (after giving effect to our 1-for-2.05 reverse stock split that occurred on December 11, 2023).
We intend to finance our clinical development programs and working capital needs from existing cash, potential new sources of debt and
equity financing, including the proceeds from our initial public offering that occurred in February of 2024. Further, the Company plans
to conduct a raise of capital in the near future to assist in financing working capital needs.
14
On
June 15, 2023, we entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, which was established by a significant shareholder of the Company. Under this Promissory Note and Loan Agreement (the
“Bay Shore Note”), we had the right to borrow up to an aggregate of $5 million from the Bay Shore Trust at any time up to
the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of our initial public offering (“IPO”).
Future advances are no longer available due to the terms of the agreement, specifically the closing of the Company’s IPO, which
was made effective on February 13, 2024. Our right to borrow funds under the Bay Shore Note was subject to the absence of a material
adverse change in its assets, operations, or prospects. The Bay Share Note, together with accrued interest, was to become due and payable
on the second anniversary of the issuance of the note, provided that prepayment at any time without penalty. The Bay Shore Note accrued
interest at a rate equal to 7% per annum, simple interest, during the first year that the note is outstanding and 10% per annum, simple
interest, thereafter. The Bay Shore Note was unsecured. As of February 9, 2024, the agreement has been terminated.
Since January 1, 2023, MIRALOGX, an intellectual property development and
holding company owned by Bay Shore Trust, established by a significant shareholder of the Company, have advanced funds on behalf of Bay Shore Trust to our company in order to fund operating
activities. The total amount advanced and outstanding as of November 30, 2023, was $1.7 million. These advances were converted into 837,841
shares of our common stock on November 30, 2023 at a conversion rate of $2.05 per share pursuant to a conversion agreement. As of the
six months ended June 30, 2024, the total amount outstanding was $0.04 million.
We
have incurred significant losses and negative cash flows from operations since inception and expect to incur additional losses until
such time that we can generate significant revenue and profit, which we do not expect to occur in the near future. We had negative cash
flow from operations of approximately $3.5 million for the six months ended June 30, 2024. As of June 30, 2024, we had cash and cash
equivalents of approximately $1.9 million and an accumulated deficit of approximately $21.7 million.
We
currently expect that our cash and cash equivalents, when taking into account the net proceeds of $5.8 million from our initial public
offering, will not be sufficient to fund our operations, development plans, and capital expenditures through Q1 2025 without additional financing. As such, there is substantial doubt about the Company’s ability to continue as a going concern.
Cash
Flows
The
following table provides information regarding our cash flows for the periods presented:
Six Months Ended June30,
2024
2023
Net cash flows from:
Operating activities
$ (3,462,259 )
$ (893,442 )
Financing activities
5,344,938
906,652
Net change in cash
$ 1,882,678
$ 13,210
Net
Cash Flows from Operating Activities
The
cash used in operating activities resulted primarily from our net losses, amortization of debt issuance costs and changes in components
of accounts payable and prepaid expenses.
For
the six months ended June 30, 2024, operating activities used $3.4 million of cash, primarily due to a net loss of $7.6 million, offset
by amortization of debt issuance costs of $4.3 million and a $0.16 million change in accounts payable, accrued and prepaid expenses.
Accounts payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance
costs, legal and accounting expenses.
15
For
the six months ended June 30, 2023, operating activities used $0.9 million of cash, primarily due to a net loss of $2.0 million, offset
by a $1 million increase in accounts payable and accrued expenses. Accounts payable and accrued expenses was primarily composed of research
and development expenses and consultant costs.
Net
Cash Flows from Financing Activities
For
the six months ended June 30, 2024, financing activities provided $5.3 million of cash, resulting primarily from $5.8 million in proceeds
from sale of common stock, less offering costs, offset by $0.4 million payments to related parties, and $0.1 million of repayments under
related party line of credit.
For
the six months ended June 30, 2023, financing activities provided $0.9 million of cash, resulting primarily from $1 million in proceeds
from sale of common stock, offset by $0.1 million net in related party borrowing and payments
Item
3. Quantitative and Qualitative Disclosures About Market Risk
We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, and therefore are not required to provide the information
under this item per Item 305(e) of Regulation S-K.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
As
of the end of the period covered by this Quarterly Report, our management, with the participation of our Chief Executive Officer (our
principal executive officer) and our Chief Financial Officer (our principal financial officer) (the “Certifying Officers”),
conducted evaluations of our disclosure controls and procedures. As defined under Sections 13a-15(e) and 15d-15(e) of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), the term “disclosure controls and procedures” means controls
and other procedures of an issuer that are designed to ensure that information required to be disclosed by the issuer in the reports
that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in
the rules and forms of the SEC. Disclosure controls and procedures include without limitation, controls and procedures designed to ensure
that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated
and communicated to the issuer’s management, including the Certifying Officers, to allow timely decisions regarding required disclosures.
Readers
are cautioned that our management does not expect that our disclosure controls and procedures or our internal control over financial
reporting will necessarily prevent all fraud and material error. An internal control system, no matter how well conceived and operated,
can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations
in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any,
within our control have been detected. The design of any system of controls also is based in part upon certain assumptions about the
likelihood of future events, and there can be no assurance that any control design will succeed in achieving its stated goals under all
potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance
with the policies or procedures may deteriorate.
During
2024, the Company has designed and implemented new and enhanced controls to strengthen the Company’s internal controls over financial
reporting, including hiring additional experienced accounting personnel, among other enhancements. Management believes these enhancements
will be sufficient to remediate previously identified material weaknesses. However, the new and enhanced controls have not operated for
a sufficient amount of time to conclude that the Company’s disclosure controls and procedures were effective. Accordingly, based
on this assessment, the Certifying Officers have concluded that our disclosure controls and procedures were not effective as of June
30, 2024.
16
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting ,other than the above mentioned hiring, as such term is defined in Rules
13a-15(f) and 15d-15(f) of the Exchange Act, during our second quarter of 2024 that materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting other than those described above.
Limitations
on the Effectiveness of Internal 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 Report that our disclosure controls and procedures were not effective
to provide reasonable assurance that the objectives of our disclosure control system were met. The Company plans to remediate the ineffectiveness
of its disclosure controls and procedures through implementation of additional levels of review and personnel with increased technical
accounting expertise.
CAUTIONARY
NOTE ON FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q contains forward-looking statements. In some cases, you can identify forward-looking statements by terms
such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,”
“could,” “intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential”, or “continue” or the negative of these terms or other
similar expressions. In particular, statements about the markets in which we operate, including growth of our various markets, and our
expectations, beliefs, plans, strategies, objectives, prospects, assumptions, or future events or performance contained in this quarterly
report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” and “Business” are forward-looking statements. We have based these forward-looking statements on our
current expectations, assumptions, estimates and projections. While we believe these expectations, assumptions, estimates, and projections
are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which
are beyond our control. These and other important factors, including those discussed in this quarterly report under the headings “Risk
Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,”
may cause our actual results, performance, or achievements to differ materially from any future results, performance or achievements
expressed or implied by these forward-looking statements, or could affect our share price. Important factors that could cause actual
results or events to differ materially from those expressed in forward-looking statements include, but are not limited to, the following:
●
our use of the net proceeds from our initial public offering;
●
our ability to obtain and maintain regulatory approval of our product candidates;
●
our ability to successfully commercialize and market our product candidates, if approved;
●
our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately;
●
the potential market size, opportunity, and growth potential for our product candidates, if approved;
●
our ability to obtain additional funding for our operations and development activities;
●
the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing;
●
the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs;
●
the timing of anticipated regulatory filings;
●
the timing of availability of data from our clinical trials;
●
our future expenses, capital requirements, need for additional financing, and the period over which we believe that the net proceeds
from this offering, together with our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital
expenditure requirements;
●
our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
●our ability to advance product candidates into, and successfully complete, clinical trials;
●
our ability to recruit and enroll suitable patients in our clinical trials;
●
the timing or likelihood of the accomplishment of various scientific, clinical, regulatory, and other product development objectives;
●
the pricing and reimbursement of our product candidates, if approved;
●
the rate and degree of market acceptance of our product candidates, if approved;
●
the implementation of our business model and strategic plans for our business, product candidates, and technology;
●
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
●
developments relating to our competitors and our industry; and
●
other risks and factors listed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December
31, 2023.
Given
the risks and uncertainties set forth in this quarterly report, you are cautioned not to place undue reliance on such forward-looking
statements. The forward-looking statements contained in this quarterly report are not guarantees of future performance and our actual
results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially
from the forward-looking statements contained in this quarterly report. In addition, even if our results of operations, financial condition
and liquidity, and events in the industry in which we operate, are consistent with the forward-looking statements contained in this quarterly
report, they may not be predictive of results or developments in future periods.
Any
forward-looking statement that we make in this quarterly report speaks only as of the date of such statement. Except as required by federal
securities laws, we do not undertake any obligation to update or revise, or to publicly announce any update or revision to, any of the
forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this quarterly report.
17
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
From
time to time, we may be named in claims arising in the ordinary course of business. Currently, no legal proceedings, government actions,
administrative actions, investigations, or claims are pending against us or involve us that, in the opinion of our management, could
reasonably be expected to have a material adverse effect on our business and financial condition.
We
anticipate that we will expend significant financial and managerial resources in the defense of our intellectual property rights in the
future if we believe that our rights have been violated. We also anticipate that we will expend significant financial and managerial
resources to defend against claims that our products and services infringe upon the intellectual property rights of third parties.
Item
1A. Risk Factors.
As
a smaller reporting company, information under this “Item 1A. Risk Factors” is not required to be presented.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
On
February 13, 2024, the Company closed its initial public offering consisting of 1,000,000 shares at a price of $7.00 per share for approximately
$7.0 million in gross proceeds. After deducting the underwriting commission and other offering expenses totaling $1.2 million, the net
proceeds to the Company was $5.8 million (the “IPO”). None of the underwriting discounts and commissions or other offering
expenses were incurred or paid, directly or indirectly, to any of our directors or officers or their associates or to persons owning
10% or more of our common stock or to any of our affiliates.
The
shares were offered and sold pursuant to the Company’s Registration Statement on Form S-1, as amended (File No. 333-275534), originally
filed with the Securities and Exchange Commission (the “SEC”) on November 14, 2023 (the “Registration Statement”)
and the final quarterly report filed with the Commission pursuant to Rule 424(b)(4) of the Securities Act of 1933, as amended. The Registration
Statement was declared effective by the Commission on February 8, 2024. The common stock began trading on The Nasdaq Capital Market on
February 9, 2024 under the symbol “TELO”. The closing of the IPO occurred on February 13, 2024.
The
net proceeds from the IPO have been used and are expected to be used, primarily to fund our clinical development programs, including
our preclinical toxicology studies, CMC activities and our initial IND application. We intend to use the remainder for working capital
and general corporate purposes. Since the completion of our IPO, we have used approximately $1.4 million of the net proceeds to fund
preclinical toxicology studies and R&D consultants, $1.5 million in general and administrative expenses and $0.9 million to related
parties for consulting services, repayment of our outstanding debt payable under our line of credit with Bay Shore Trust and variable
lease costs related to the aircraft shared lease expenses as referenced in Note 5 of the financial statements.
Item
3. Defaults upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
applicable.
18
Item
5. Other Information.
Passing
of Dr. Christopher Chapman
On
August 8, 2024, the Company was made aware of the passing of its Chairman and Chief Executive Officer, Dr. Christopher Chapman.
Restructuring
of the Board of Directors
On
August 8, 2024, Ms. Talhia Tuck, Mr. Brad Kroenig and Mr. Hugh McColl, each voluntarily resigned from the Board, effective immediately
(the “Board Resignations”). Subsequent thereto, the remaining members of the Board appointed new members of the Board, as
discussed below. The resignations of Ms. Tuck, Mr. Kroenig, and Mr. McColl were not the result of any disagreement with the Company on
any matter relating to its operations, policies or practices.
On
August 8, 2024, the remaining members of the Board (Dr. Craig Eagle, M.D. and Michael Jerman) unanimously approved the appointment
of Mr. Erez Aminov, Dr. Matthew P. Del Giudice, Mr. Matthew Pratt Whalen and Mr. Ned MacPherson as members of the Board, to fill the vacancies
on the Board occasioned by the Board Resignations and the passing of Dr. Chapman, for a term expiring at the Company’s 2024 annual
meeting of stockholders.
The
following is certain biographical information regarding Dr. Del Giudice and Messrs. Aminov, Whalen and MacPherson:
Erez
Aminov , age 46, has served as a director and Chief Executive Officer of MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA), a preclinical-stage
pharmaceutical company focused on the development and commercialization of a new molecular synthetic cannabinoid analog for the treatment
of adult patients with neuropathic pain as well as anxiety and cognitive decline typically associated with early-stage dementia, since
April 2023 and its Chairman since March 2024. In this role, Mr. Aminov leads the development and commercialization of MIRA’s lead
candidate . Mr. Aminov’s experience in the biotech consulting sector began in 2021 when he founded
Locate Venture Corp. in September 2021. Locate Venture is a strategy and investment consulting firm focused on advancing and supporting
early-stage biotech startups. Prior to founding Locate Venture Corp., from February 2015 to September 2020, Mr. Aminov served as the
President of Finds4less Inc., a global distributor of electronics and gaming products. In this role, Mr. Aminov provided strategic oversight
and direction for all aspects of the company’s operations, while also spearheading new business development initiatives to capitalize
on emerging market opportunities. Mr. Aminov’s more than two decades of experience includes experience with the biotech industry’s
particular challenges, including creating strategic alliances and guiding startups toward growth and prosperity. Mr. Aminov earned a
B.A. in Accounting from Touro University in New York. We believe that Mr. Aminov is qualified to serve as one of our directors based
on his finance and investment experience, particularly with early-stage life sciences companies.
Dr.
Matthew P. Del Giudice , age 42, has practiced as a radiologist since 2014. He currently serves as a general overnight emergency radiologist
at the Cleveland Clinic. Since March 2024, he has also served as a director of
MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA). Prior to joining the Cleveland Clinic, from March 2021 to May 2022, Dr. Del Giudice was a
general radiologist with Radiology and Imaging Specialists in Phoenix, Arizona. From July 2015 to February 2021, Dr. Del Giudice was
a radiologist with Radiology Partners Phoenix, and from July 2014 to June 2015, he practiced as a musculoskeletal radiologist at the
University of Arizona Health Sciences Center – Tucson. Dr. Del Giudice received his B.S. from the University of Illinois at Urbana-Champaign,
his M.D. from Loyola University Stritch School of Medicine, completed his radiology residency at Loyola University Medical Center, and
his musculoskeletal radiology fellowship at the University of Arizona Health Sciences Center – Tucson. Dr. Del Giudice is licensed
to practice medicine in Florida and Ohio. We believe that Dr. Del Giudice is qualified to serve as one of our directors based on his
extensive experience as a radiologist.
19
Matthew
Pratt Whalen, CPA, age 45, is a Certified Public Accountant with over two decades of experience in public accounting and
corporate finance. Mr. Whalen currently serves as the Chief Financial Officer of Power Digital Marketing Inc., an industry leading
digital marketing agency, where he has driven significant revenue growth and led key financial transactions. Specifically, Mr.
Whalen oversees the finance team, manages tax and audit relationships, and handles treasury management. Prior to joining Power
Digital, from 2010 to May 2021, Mr. Whalen was the Chief Financial Officer of MRC Smart Technology Solutions, a subsidiary of
Xerox Corporation where he played a pivotal role in growing the company’s revenue and managed diverse teams across multiple
departments. Mr. Whalen holds a B.A. in Accounting from the University of San Diego and is a Certified Public Accountant in
California. Mr. Whalen has also served on the Finance Committee of United Way San Diego. We believe that Mr. Whalen is qualified to serve as one of our directors
based on his extensive experience in finance and as a Certified Public Accountant.
Ned
MacPherson, age 36, currently serves as Chief Growth Officer for Power Digital, an industry leading digital marketing agency.
Since March 2024, he has also served as a director of MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA). Prior to joining Power Digital, from
May 2016 to December 2023, he served as CEO and Head of Growth for Endrock Growth & Analytics, a company he founded and sold to Power
Digital. Prior to founding Endrock Growth & Analytics, Mr. MacPherson held senior marketing and leadership positions at sunglass
maker Prive Revaux (March 2018 to April 2020), curated meal company Menud (October 2014 to April 2018) and Rejuvenetics, LLC, a distributor
of health and wellness products (December 2012 to March 2016). Mr. Macpherson holds a BA in Economics from Gettysburg College. We believe
that Mr. MacPherson is qualified to serve as one of our directors based on his extensive experience assisting growth for early-stage
companies.
On August 9, 2024, to fill the vacancies left by the passing of Dr. Chapman, the new Board unanimously approved the
appointment of Mr. Aminov as the Company’s Chief Executive Officer and Chairman of the Board. Additionally, the new Board designated
the new members of the Audit, Compensation and Nominating and Corporate Governance Committees in conformance with the rules of the Nasdaq
Stock Market. Accordingly, the new (i) Audit Committee shall consist of Mr. Jerman (Chairman), Mr. Whalen and Mr. Macpherson, (ii) Compensation
Committee shall consist of Dr. Del Giudice (Chairman) and Mr. Macpherson and (iii) Nominating and Corporate Governance Committee shall
consist of Mr. Eagle (Chairman) and Dr. Del Giudice.
Employment
Agreement with Erez Aminov
Effective
August 12, 2024, we entered into an employment agreement with Mr. Aminov, pursuant to which Mr. Aminov will serve as our Chief
Executive Officer and Chairman of our Board. Under his employment agreement, Mr. Aminov has agreed to devote reasonable business
time and effort to the business and affairs of the Company. Mr. Aminov’s employment agreement provides that his employment
will be on an at-will basis and can be terminated by either Mr. Aminov or our company at any time and for any reason. Under the
agreement, Mr. Aminov will receive a base salary of $0.275 million per year. In the event that Mr. Aminov’s employment is
terminated by our company without “Cause” or is terminated by Mr. Aminov for “Good Reason”, Mr. Aminov will
be entitled to (1) be paid an amount equal to Mr. Aminov’s annual base salary, which payment shall be made seventy-five percent
(75%) in a lump sum within thirty (30) days following the effective date of the general release of claims (following any revocation period)
and twenty-five percent (25%) as salary continuation payments in substantially equal installments over the six (6) months following the
release effective date in accordance with our customary payroll practices commencing on the first payroll date following the release effective
date, and (2) receive twelve (12) months’ accelerated vesting of any stock options that are outstanding and unvested as of such
termination, such that any outstanding and unvested stock options that would have vested during the twelve- (12) month period following
the termination date had Mr. Aminov remained employed in good standing shall become immediately vested and exercisable for a period of
three (3) months post-termination (subject to Mr. Aminov
executing and delivering a customary general release in favor of the company). “Cause” is defined in the agreement to
include dishonesty, misappropriation, willful misconduct, breach of the agreement, and other customary matters. “Good
Reason” is defined to include a material adverse change in Mr. Aminov’s compensation or duties and level of
responsibility. The employment agreement also contains customary confidentiality and invention-assignment covenants to which Mr.
Aminov is subject
20
Item
6. Exhibits.
Number
Description
10.1
Employment Agreement between the Company and Erez Aminov, dated August 12, 2024.
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 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 and Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
Employment Agreement by and between the Company and Michelle Yanez, dated June 18, 2024 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed on June 24, 2024)
101.INS*
Inline
XBRL Instance Document
101.SCH*
Inline
XBRL Taxonomy Extension Schema
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase
104*
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
*
Furnished
herewith
+
Denotes
management contract or compensatory plan or arrangement.
21
SIGNATURES
Pursuant
to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
TELOMIR
PHARMACEUTICALS, INC.
Date:
August 13, 2024
By:
/s/
Erez Aminov
Erez
Aminov
Chief
Executive Officer
(Principal
Executive Officer)
Date:
August 13, 2024
By:
/s/
Michelle Yanez
Michelle
Yanez
Chief
Financial Officer, Treasurer and Secretary
(Principal
Financial Officer)
22
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.