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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 March 31, 2026
| ☐ |
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 001-13467
Inhibitor
Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
30-0793665 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
No.) |
| |
|
|
3014
W. Palmira Avenue Suite 302
Tampa,
FL |
|
33629-7264 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number (including area code):
813-864-2562
Not
Applicable
(Former
name, former address and former fiscal year, if changed since last report)
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 May 15, 2026, there were 172,573,545 shares of company common stock issued and outstanding.
Inhibitor
Therapeutics, 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 March 31, 2026 and December 31, 2025 |
1 |
| |
|
|
| |
Condensed Statements of Operations for the three months ended March 31, 2026 and 2025 |
2 |
| |
|
|
| |
Condensed Statements of Stockholders’ (Deficit) Equity for the three months ended March 31, 2026 and 2025 |
3 |
| |
|
|
| |
Condensed Statements of Cash Flows for the three months ended March 31, 2026 and 2025 |
4 |
| |
|
|
| |
Notes to Condensed Financial Statements |
5 |
| |
|
|
| Item
2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
9 |
| |
|
|
| Item
3. |
Quantitative and Qualitative Disclosures about Market Risk |
11 |
| |
|
|
| Item
4. |
Controls and Procedures |
11 |
| |
|
|
| Cautionary Note Regarding Forward Looking Statements |
12 |
| |
|
|
| Part II. Other Information |
|
| |
|
|
| Item
1 |
Legal Proceedings |
13 |
| |
|
|
| Item
1A. |
Risk Factors |
13 |
| |
|
|
| Item
2 |
Unregistered Sales of Equity Securities and Use of Proceeds |
13 |
| |
|
|
| Item
3 |
Defaults upon Senior Securities |
13 |
| |
|
|
| Item
4 |
Mine Safety Disclosures |
13 |
| |
|
|
| Item
5 |
Other Information |
13 |
| |
|
|
| Item
6. |
Exhibits |
14 |
| |
|
|
| Signatures |
15 |
INHIBITOR
THERAPEUTICS, INC.
CONDENSED
BALANCE SHEETS
AS
OF MARCH 31, 2026 AND DECEMBER 31, 2025
(Unaudited)
| | |
March
31, 2026 | | |
December
31, 2025 | |
| ASSETS | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 1,290,978 | | |
$ | 2,375,493 | |
| Prepaid expenses and other assets | |
| 84,975 | | |
| 71,507 | |
| Total current assets | |
| 1,375,953 | | |
| 2,447,000 | |
| Operating lease right-of-use assets | |
| 57,410 | | |
| 64,307 | |
| Total assets | |
$ | 1,433,363 | | |
$ | 2,511,307 | |
| LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 319,803 | | |
$ | 51,521 | |
| Accrued expenses and other liabilities | |
| 33,536 | | |
| 690,085 | |
| Current portion of operating lease obligations | |
| 28,981 | | |
| 24,724 | |
| Total current liabilities | |
| 382,320 | | |
| 766,330 | |
| Deferred revenue | |
| 3,000,000 | | |
| 3,000,000 | |
| Operating lease obligations, less current portion | |
| 29,380 | | |
| 36,889 | |
| Total liabilities | |
| 3,411,700 | | |
| 3,803,219 | |
| Commitments and contingencies (Note 6) | |
| — | | |
| — | |
| | |
| | | |
| | |
| Stockholders’ deficit: | |
| | | |
| | |
| Series A preferred stock, $0.0001 par value; 500,000 shares authorized; no shares issued and outstanding at March 31, 2026 and December 31, 2025 | |
| — | | |
| — | |
| Series B Convertible Preferred Stock, $0.0001 par value; 7,246,377 shares authorized; no shares issued and outstanding at March 31, 2026 and December 31, 2025 | |
| — | | |
| — | |
| Undesignated Preferred Stock, $0.0001 par value; 2,253,623 shares authorized; no shares issued or outstanding at March 31, 2026 and December 31, 2025 | |
| — | | |
| — | |
| Preferred stock, value | |
| — | | |
| — | |
| Common stock, $0.0001 par value; 500,000,000 shares authorized; 172,573,545 shares issued and outstanding at March 31, 2026 and December 31, 2025 | |
| 17,257 | | |
| 17,257 | |
| Additional paid-in capital | |
| 54,110,425 | | |
| 54,110,425 | |
| Accumulated deficit | |
| (56,106,019 | ) | |
| (55,419,594 | ) |
| Total stockholders’ deficit | |
| (1,978,337 | ) | |
| (1,291,912 | ) |
| Total liabilities and stockholders’ deficit | |
$ | 1,433,363 | | |
$ | 2,511,307 | |
See
notes to condensed financial statements
INHIBITOR
THERAPEUTICS, INC.
CONDENSED
STATEMENTS OF OPERATIONS
FOR
THE THREE MONTHS ENDED MARCH 31, 2026 AND 2025
(Unaudited)
| | |
2026 | | |
2025 | |
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| Revenues | |
$ | — | | |
$ | — | |
| Expenses | |
| | | |
| | |
| Research and development | |
| 340,562 | | |
| 236,058 | |
| General and administrative | |
| 355,070 | | |
| 438,493 | |
| Total expenses | |
| 695,632 | | |
| 674,551 | |
| Loss from operations | |
| (695,632 | ) | |
| (674,551 | ) |
| | |
| | | |
| | |
| Other income: | |
| | | |
| | |
| Interest income | |
| 9,207 | | |
| 41,705 | |
| Net loss | |
$ | (686,425 | ) | |
$ | (632,846 | ) |
| Basic and diluted net loss per share | |
$ | (0.00 | ) | |
$ | (0.00 | ) |
| Weighted average common stock shares outstanding – basic and diluted | |
| 172,573,545 | | |
| 172,323,545 | |
See
notes to condensed financial statements
INHIBITOR
THERAPEUTICS, INC.
CONDENSED
STATEMENTS OF STOCKHOLDERS’ (DEFICIT) EQUITY
FOR
THE THREE MONTHS ENDED MARCH 31, 2026 AND 2025
(Unaudited)
| | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
(Deficit) Equity | |
| | |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
Total Stockholders’ | |
| | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
(Deficit) Equity | |
| Balance, January 1, 2026 | |
| 172,573,545 | | |
$ | 17,257 | | |
$ | 54,110,425 | | |
$ | (55,419,594 | ) | |
$ | (1,291,912 | ) |
| Net loss | |
| — | | |
| — | | |
| — | | |
| (686,425 | ) | |
| (686,425 | ) |
| Balances, March 31, 2026 | |
| 172,573,545 | | |
$ | 17,257 | | |
$ | 54,110,425 | | |
$ | (56,106,019 | ) | |
$ | (1,978,337 | ) |
| | |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
Total Stockholders’ | |
| | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
(Deficit) Equity | |
| Balance, January 1, 2025 | |
| 172,323,545 | | |
$ | 17,232 | | |
$ | 54,087,065 | | |
$ | (52,119,257 | ) | |
$ | 1,985,040 | |
| Balance | |
| 172,323,545 | | |
$ | 17,232 | | |
$ | 54,087,065 | | |
$ | (52,119,257 | ) | |
$ | 1,985,040 | |
| Net loss | |
| — | | |
| — | | |
| — | | |
| (632,846 | ) | |
| (632,846 | ) |
| Balances, March 31, 2025 | |
| 172,323,545 | | |
$ | 17,232 | | |
$ | 54,087,065 | | |
$ | (52,752,103 | ) | |
$ | 1,352,194 | |
| Balance | |
| 172,323,545 | | |
$ | 17,232 | | |
$ | 54,087,065 | | |
$ | (52,752,103 | ) | |
$ | 1,352,194 | |
See
notes to condensed financial statements
INHIBITOR
THERAPEUTICS, INC.
CONDENSED
STATEMENTS OF CASH FLOWS
FOR
THE THREE MONTHS ENDED MARCH 31, 2026 AND 2025
(Unaudited)
| | |
2026 | | |
2025 | |
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| Operating activities: | |
| | | |
| | |
| Net loss | |
$ | (686,425 | ) | |
$ | (632,846 | ) |
| Adjustments to reconcile net loss to net cash flows from operating activities: | |
| | | |
| | |
| Non-cash lease expense | |
| 159 | | |
| 80 | |
| Changes in assets and liabilities: | |
| | | |
| | |
| Prepaid expenses | |
| (13,468 | ) | |
| (11,310 | ) |
| Accounts payable and other current liabilities | |
| (384,781 | ) | |
| (640,893 | ) |
| Net cash flows from operating activities | |
| (1,084,515 | ) | |
| (1,284,969 | ) |
| Net change in cash and cash equivalents | |
| (1,084,515 | ) | |
| (1,284,969 | ) |
| Cash and cash equivalents at beginning of period | |
| 2,375,493 | | |
| 5,606,863 | |
| Cash and cash equivalents at end of period | |
$ | 1,290,978 | | |
$ | 4,321,894 | |
| | |
| | | |
| | |
| Supplemental disclosure of non-cash investing and financing activities: | |
| | | |
| | |
| Operating right-of-use assets obtained in exchange for lease obligations | |
$ | — | | |
$ | 86,420 | |
See
notes to condensed financial statements
INHIBITOR
THERAPEUTICS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED MARCH 31, 2026, AND 2025
(Unaudited)
1.
Corporate Overview
Overview
The
accompanying condensed financial statements have been prepared without audit. In the opinion of management, all adjustments (which include
normal recurring adjustments) necessary to present fairly the condensed financial position, results of operations and cash flows as of
March 31, 2026, and for all periods presented, have been made.
Certain
information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally
accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange
Commission (“SEC”) rules and regulations. These unaudited condensed financial statements should be read in conjunction with
the audited financial statements and notes thereto for the year ended December 31, 2025, which are included in the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2025 (the “2025 Annual Report”). The accompanying condensed balance
sheet as of December 31, 2025 has been derived from the audited financial statements at that date but does not include all information
and footnotes required by GAAP for complete financial statements.
As
used herein, the term “common stock” means the Company’s common stock, $0.0001 par value per share.
The
results of operations for the three months ended March 31, 2026, are not necessarily indicative of results that may be expected for any
other interim period or for the full fiscal year. Readers of this Quarterly Report are strongly encouraged to review the risk factors
relating to the Company which are set forth in the 2025 Annual Report and the Company’s other filings with the SEC.
Nature
of the Business
The
Company is a pharmaceutical development company focused on developing and ultimately commercializing innovative therapeutics based on
already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery for patients with certain
cancers and certain non-cancerous proliferation disorders. The Company has also evaluated and may continue to evaluate, opportunities
to acquire or license innovative pre-clinical and clinical stage therapeutics addressing unmet medical needs in cancer and other disease
indications, including therapies involving the repurposing of active ingredients from existing approved drugs.
The
Company’s primary focus is on the development of therapies initially for basal cell carcinoma (“BCC”) cancer in the
United States utilizing itraconazole, a drug currently approved by the FDA to treat fungal infections, and which has an extensive history
of safe and effective use in humans. The Company has developed intellectual property and know-how related to the treatment of cancer
patients using itraconazole. In particular, on December 12, 2023, the Company entered into an Exclusive License Agreement (the “Agreement”)
with Johns Hopkins University (“JHU”). Pursuant to the Agreement, JHU granted to the Company the exclusive worldwide patent
rights to a Granted US Patent, No. 8,980,930 entitled “New Angiogenesis Inhibitors” (the “Patent”). The Patent
relates to the treatment of prostate cancer, BCC including basal cell carcinoma nevus syndrome (“BCCNS”), and lung cancer.
2.
Going Concern
These
condensed 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.
The
Company has incurred losses and negative cash flows from operations and expects to incur additional losses until such time that it can
generate significant revenue from the licensing of a product once approved by the FDA, which will allow for commercialization of the
product candidate. During the three months ended March 31, 2026, the Company incurred a net loss of $0.7 million and had negative cash
flows from operations of $1.1 million. Given the Company’s projected operating requirements and its existing cash and cash equivalents,
the Company is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements
are issued before giving consideration to management’s plans to address such conditions. These conditions and events raise substantial
doubt about the Company’s ability to continue as a going concern.
INHIBITOR
THERAPEUTICS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED MARCH 31, 2026, AND 2025
(Unaudited)
In
response to these conditions, management is currently evaluating the scope of the Company’s 2026 operations, including potential
financing strategies that include, but are not limited to, the public or private sale of equity or debt securities or from loans or through
other strategic collaboration and/or from licensing agreements. On February 19, 2026, the Company entered into a securities purchase
agreement with an institutional investor, pursuant to which the Company agreed to sell and issue shares of common stock and warrants
in a registered direct offering in exchange for proceeds of $3.0 million. The securities are subject to certain contractual restrictions
on transfer, including a nine-month lock-up period. The proceeds have not yet been received and on March 30, 2026 the Company initiated
litigation as a result of the institutional investor’s failure to perform its obligations under the securities purchase agreement,
including funding the $3.0 million investment in the Company. In the event the proceeds are received, the Company intends to use the
proceeds from the offering for working capital and other general corporate purposes.
The
Company believes that the impact on its liquidity and cash flow resulting from the offering, once the proceeds are received, will mitigate
some of the risk related to the substantial doubt about the Company’s ability to continue as a going concern. However, there can
be no assurances that the proceeds will be received pursuant to the securities purchase agreement. Because management’s plans have
not yet been fully executed 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 currently alleviate substantial doubt about the Company’s
ability to continue as a going concern.
The
condensed 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.
3.
Summary of Significant Accounting Policies
Estimates
The
preparation of condensed financial statements requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported
amounts of revenues and expenses during the period. Actual results could differ from those estimates.
Revenue
Recognition
The
Company currently has no ongoing source of revenue. Other income, including interest, is recognized when earned by the Company. Deferred
revenue represents cash received for royalties in advance of being earned. Such payments are reflected as deferred revenue until recognized
under the Company’s revenue recognition policy. Deferred revenue would be classified as current if management believes the Company
will be able to recognize the deferred amount as revenue within twelve months of the balance sheet date. Deferred revenue will be recognized
when the product is sold and the royalty is earned. Since all deferred revenue is related to the BCCNS product, which is yet to be approved
by the FDA, the Company has determined that 100% of the advances of the royalty received from Mayne Pharma Ventures Pty Ltd. (“Mayne
Pharma”) should be classified as non-current. As of March 31, 2026 and December 31, 2025, deferred revenue consisted of $3 million
of royalties advanced by Mayne Pharma under the Third Amended Supply and License Agreement (“SLA”).
Cash
and Cash Equivalents
The
Company considers all highly liquid debt instruments purchased with an original maturity of three months or less to be cash equivalents.
The Company maintains cash balances in bank accounts in excess of Federal Deposit Insurance Corporation insured amounts. The Company
continues to monitor the third-party depository institutions that hold the Company’s cash and limits its cash deposits to financial
institutions with high credit standing. The Company has not experienced any losses in these accounts to date.
Research
and Development Expenses
Research
and development (“R&D”) costs are expensed in the period in which they are incurred and include salaries, benefits and
other related costs to support the Company’s R&D operations, amounts paid to third parties who conduct research and development
activities on behalf of the Company, as well as the costs of discovery research, preclinical and clinical development, drug formulation
and licensing payments. Upfront and advanced licensing payments for future use in R&D activities are recorded as prepaid expenses
and are expensed as the related services are performed.
INHIBITOR
THERAPEUTICS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED MARCH 31, 2026, AND 2025
(Unaudited)
General
and Administrative Expenses
General
and administrative (“G&A”) expenses are expensed in the period in which they are incurred and include operating expenses
not classified as R&D expenses, such as salaries, benefits, insurance, board of directors’ fees, travel costs, as well as fees
for professional services related to accounting, tax and legal matters.
Stock-Based
Compensation
The
Company accounts for stock-based awards to employees and non-employees using a fair value-based method to determine compensation for
all arrangements where shares of stock or equity instruments are issued for compensation. Fair values of restricted stock units issued
are determined by the Company based predominantly on the trading price of the common stock on the date of grant. The fair value of each
common stock option is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility,
expected dividends, expected term, and the risk-free interest rate. Expected volatility is based on historical volatility of a peer group’s
common stock and other factors estimated over the expected term of the options. The expected term of the options granted is derived using
the “simplified method” which computes the expected term as the average of the weighted-average vesting term and the contract
term. The risk-free rate is based on the U.S. Treasury yield.
Income
Taxes
Deferred
tax assets and liabilities are recognized for future tax consequences attributed to differences between the financial statement carrying
amounts of existing assets and liabilities and their respective tax bases and are measured using enacted tax rates that are expected
to apply to the differences in the periods that they are expected to reverse.
Leases
The
Company recognizes on its balance sheet right-of-use assets and lease liabilities associated with lease agreements based on the present
value of the future lease payments over the contractual lease term using its incremental borrowing rate on the lease commencement date.
The Company has elected not to recognize a lease liability or right-of-use asset on the balance sheet for leases with an initial term
of 12 months or less. Operating lease expenses on capitalized leases and short-term leases are recognized on a straight-line basis over
the respective lease term, inclusive of rent escalation provisions and rent abatements, as a component of general and administrative
expenses in the statements of operations.
Recent
accounting pronouncements
Management
has considered all recent accounting pronouncements issued, but not effective, and does not believe that any will have a material impact
on the Company’s results of operations or financial position.
4.
Related Party Transactions
The
Company has engaged Avior Bio, Inc. (“Avior”) for the development of a novel formulation of itraconazole. Avior is a privately
held drug development company whose President and Chairman of the Board, Niraj Vasisht, is a member of the Company’s Board of Directors.
During the three months ended March 31, 2026, the Company incurred $0.1 million of costs associated with its engagement of Avior. During
the three months ended March 31, 2025, the Company did not incur any costs associated with its engagement of Avior.
5.
Stockholders’ Equity
On
February 19, 2026, the Company entered into a securities purchase agreement (the “SPA”) with an institutional investor to
sell 12 million shares of its common stock and to issue a common stock purchase warrant to purchase up to 7 million additional shares
of common stock (the “Warrant”) in exchange for proceeds of $3.0 million. The Warrant has an exercise price of $0.35 per
share and a term of three years. The proceeds have not yet been received from the institutional investor in accordance with the securities
purchase agreement. On March 30, 2026, the Company initiated litigation against the investor, as a result of the investor’s failure
to complete the financing and fulfill its obligations under the SPA including, without limitation, funding the $3.0 million investment
in the Company provided therein.
INHIBITOR
THERAPEUTICS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED MARCH 31, 2026, AND 2025
(Unaudited)
Employee
Stock Plans
There
were no grants of restricted common stock during either of the three months ended March 31, 2026 or 2025. There were no common stock
options issued during either the three months ended March 31, 2026 or 2025.
As
of March 31, 2026, there were 3,080,646 outstanding common stock options under the Company’s equity incentive plan of which 100%
were vested. There was no unamortized stock-based compensation as of March 31, 2026. The weighted-average remaining contractual life,
weighted-average exercise price per share and the aggregate intrinsic value of the outstanding common stock options as of March 31, 2026
were 4.3 years, $0.09 and approximately $0.2 million, respectively.
6.
Commitments and Contingencies
Legal
Proceedings
The
Company may from time to time become a party to various legal proceedings arising in the ordinary course of business. The Company is
not currently the subject of any legal proceedings other than the litigation initiated by the Company discussed in Note 5.
7.
Segment Information
The
Company operates in one reportable segment related to the development and commercialization of therapeutics. The chief operating decision
maker (“CODM”) for the Company is the Chief Executive Officer (the “CEO”). The Company’s CODM reviews operating
results on an aggregate basis and manages the Company’s operations as a whole for the purpose of evaluating financial performance
and allocating resources. Accordingly, the Company has determined that it has a single reportable and operating segment structure. The
CODM uses aggregate net loss to allocate resources in the annual budgeting and forecasting process and also uses that measure as a basis
for evaluating financial performance regularly by comparing actual results with established budgets and forecasts.
The
accounting policies of the Company’s single segment are the same as those described in the summary of significant accounting policies
within Note 3. The CODM assesses performance for the Company and decides how to allocate resources based on the aggregate net loss that
is also reported on the income statement as net loss. Segment assets are reported on the balance sheets as total assets.
The
table below provides information about the Company’s revenue, significant segment expenses and other segment expenses.
Schedule
of Revenue, Significant Segment Expenses and Other Segment Expenses
| | |
2026 | | |
2025 | |
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| Revenues | |
$ | — | | |
$ | — | |
| Less: | |
| | | |
| | |
| Research and development | |
| 340,562 | | |
| 236,058 | |
| General and administrative | |
| 355,070 | | |
| 438,493 | |
| Loss from operations | |
| (695,632 | ) | |
| (674,551 | ) |
| Plus: | |
| | | |
| | |
| Interest income | |
| 9,207 | | |
| 41,705 | |
| Net loss | |
$ | (686,425 | ) | |
$ | (632,846 | ) |
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with our Condensed
Financial Statements and Notes thereto included elsewhere in this Quarterly Report. This discussion and analysis contain certain forward-looking
statements that involve risks, uncertainties and assumptions. Actual results and the timing of certain events may differ materially from
those discussed in these forward-looking statements as a result of certain factors, including, but not limited to, those which are not
within our control.
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 Inhibitor
Therapeutics, Inc.
Background
of Our Company
We
are a pharmaceutical development company that is focused on developing and ultimately commercializing innovative therapeutics based on
already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery for patients with certain
cancers and certain non-cancerous proliferation disorders. We have also evaluated, and may continue to evaluate, opportunities to acquire
or license innovative pre-clinical and clinical stage therapeutics addressing unmet medical needs in cancer and other disease indications,
including therapies involving the repurposing of active ingredients from existing approved drugs.
Our
current primary focus is on the development of therapies initially for basal cell carcinoma nevus syndrome (“BCCNS”) cancers
in the United States utilizing itraconazole, a drug currently approved by the FDA to treat fungal infections, and which has an extensive
history of safe and effective use in humans. We have developed intellectual property and know-how related to the treatment of cancer
patients using itraconazole.
On
December 12, 2023, we entered into an Exclusive License Agreement (the “Agreement”) with Johns Hopkins University (“JHU”)
pursuant to which, JHU granted to our Company the exclusive worldwide patent rights to a Granted US Patent, No. 8,980,930 entitled “New
Angiogenesis Inhibitors” (the “Patent”). The Patent relates to the treatment of prostate cancer, basal cell carcinoma
(“BCC”) including BCCNS, and lung cancer. Pursuant to the Agreement, we paid JHU an upfront license fee of $40,000. In addition
to compliance with customary terms and conditions included in the Agreement, we are contractually obligated to pay JHU certain additional
consideration, including the following:
| |
● |
Royalties
within the mid-single digit percentages based on net sales generated from a licensed product, with net sales generated from a licensed
product that has exclusivity in the United States due solely to the patent rights provided pursuant the Agreement subject to a higher
percentage; |
| |
● |
Remaining
Minimum Annual Royalty (“MAR”) payments of $50,000 due January 1, 2027 and every year thereafter until the first commercial
sale of an associated licensed product. Following the first commercial sale of an associated licensed product, every year thereafter
throughout the remaining term of the Agreement the MAR payment is $150,000; |
| |
● |
A
low-double digit percentage of any consideration received from a sublicensee; and |
| |
● |
Certain
development-related milestone payments in the aggregate of $3.0 million upon achievement of a series of agreed upon milestones, including
a successful Phase 3 clinical trial, as well as commercialization and the FDA approval of a licensed product, as defined within the
Agreement. |
We
have engaged Avior Bio, Inc. (“Avior”), to develop a novel formulation of itraconazole. Avior has completed the formulation
development process, and upon finalization, will conduct a pharmacokinetic (“PK”) crossover study of the generic formulation
and the formulation that was used within the HP2001 study in preparation for a new pre-IND and New Drug Application (“NDA”).
As all formulations consist of the same active pharmaceutical ingredients (“API”), we expect that our new, novel formulation
to exhibit pharmacological properties extremely similar to those of the formulation used in the HP2001 clinical study.
In
October 2025, we entered into a performance-based master services agreement with Frameshift Management, Inc. (“Frameshift”)
to provide regulatory, biostatistical and strategic consulting services supporting our lead development program targeting basal cell
carcinomas associated with Gorlin Syndrome. Frameshift performs services under project-specific statements of work supporting our preparation
of regulatory submissions, coordination of supporting analyses and overall advancement of our BCCNS development strategy. Frameshift
supported us in the preparation of a regulatory meeting request and associated briefing materials submitted to the FDA in February 2026
and is expected to assist in the preparation of materials supporting a potential NDA subject to regulatory feedback and the outcome of
FDA discussions regarding our proposed development pathway.
Critical
Accounting Policies
Our
critical accounting policies require management to make estimates and assumptions that affect the reported amounts in the financial statements
and the accompanying notes. These estimates are based on historical experience, the advice of external experts or on other assumptions
management believes to be reasonable. Where actual amounts differ from estimates, revisions are included in the results for the period
in which actual amounts become known. Historically, differences between estimates and actual amounts have not had a significant impact
on our financial statements. Critical accounting policies and estimates used to prepare the financial statements are discussed with the
Audit Committee of our Board of Directors as they are implemented and on an annual basis.
We
have no material changes to our Critical Accounting Policies and Estimates disclosure as filed in our 2025 Annual Report.
Results
of Operations
For
the three months ended March 31, 2026 compared to the three months ended March 31, 2025
Research
and Development Expenses. We incurred $0.3 million and $0.2 million of research and development expenses during the three months
ended March 31, 2026 and March 31, 2025, respectively. The expenses are primarily internal personnel costs, consisting of salaries, benefits
and other related costs, as well as amounts paid to third parties to support our research and development activities. The increase quarter-over-quarter
is primarily the result of the fees associated with the services provided by Frameshift during the period. We expect research and development
expenses to continue to increase in the future, depending on the results from our upcoming FDA meetings.
General
and Administrative Expenses. We incurred approximately $0.4 million in general and administrative expenses during each of the three
months ended March 31, 2026 and March 31, 2025. During each of the three months ended March 31, 2026 and 2025, general and administrative
expenses were comprised primarily of compensation costs of $0.2 million, professional services fees of $0.1 million, and insurance costs
of $0.1 million.
Interest
income. We earned approximately $0.01 million and $0.04 million of interest income during the three months ended March 31, 2026 and
March 31, 2025, respectively. The interest income is generated from deposits held in our depository accounts and the decrease of $0.03
million compared to the prior period is the result of less deposits within our money market account during the current period.
Liquidity
and Capital Resources
We
have incurred losses and negative cash flows from operations and expect to incur additional losses until such time that we can generate
significant revenue from the licensing of a product once we receive approval by the FDA, which will allow for commercialization of the
product candidate. During the three months ended March 31, 2026, we incurred a net loss of $0.7 million and had negative cash flows from
operations of $1.1 million. Given our projected operating requirements and our existing cash and cash equivalents, we are projecting
insufficient liquidity to sustain our operations through one year following the date that the financial statements are issued before
giving consideration to management’s plans to address such conditions. These conditions and events raise substantial doubt about
our ability to continue as a going concern.
In
response to these conditions, management is currently evaluating the scope of our 2026 operations, including potential financing strategies
that include, but are not limited to, the public or private sale of equity or debt securities or from loans or through other strategic
collaboration and/or from licensing agreements. On February 19, 2026, we entered into a securities purchase agreement with an institutional
investor, pursuant to which we agreed to sell and issue shares of common stock and warrants in a registered direct offering in exchange
for proceeds of $3.0 million. The securities are subject to certain contractual restrictions on transfer, including a nine-month lock-up
period. The proceeds have not yet been received and on March 30, 2026 we initiated litigation as a result of the institutional investor’s
failure to perform its obligations under the securities purchase agreement, including funding the $3.0 million investment. In the event
the proceeds are received, we intend to use the proceeds from the offering for working capital and other general corporate purposes.
We
believe that the impact on our liquidity and cash flows resulting from the offering, once the proceeds are received, will mitigate some
of the risk related to the substantial doubt about our ability to continue as a going concern. However, there can be no assurances that
the proceeds will be received pursuant to the securities purchase agreement. Because our plans have not yet been fully executed and are
not within our control, the implementation of such plans cannot be considered probable. As a result, we have concluded that our plans
do not currently alleviate substantial doubt about our ability to continue as a going concern.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
None.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
As
of the end of the period covered by this Quarterly Report, the Company’s management, with the participation of the Company’s
Chief Executive Officer and Interim Chief Financial Officer (the “Certifying Officers”), conducted evaluations of our disclosure
controls and procedures. As defined under Sections 13a–15I 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.
Based
on this evaluation, the Certifying Officers have concluded that our disclosure controls and procedures were effective.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting during our first fiscal quarter of 2026 that materially affected, or
are reasonably likely to materially affect, our internal control over financial reporting.
Limitations
on the Effectiveness of Internal Controls
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.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain
information set forth in this Quarterly Report on Form 10-Q, including in Item 2, “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” (and the “Liquidity and Capital Resources” section thereof) and elsewhere
may address or relate to future events and expectations and as such constitutes “forward-looking statements” within the meaning
of the Private Securities Litigation Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements
may include, without limitation, statements with respect to our plans, objectives, projections, expectations and intentions and other
statements identified by words such as “projects”, “may”, “could”, “would”, “should”,
“believes”, “expects”, “anticipates”, “estimates”, “intends”, “plans”
or similar expressions. These statements are based upon the current beliefs and expectations of our management and are subject to significant
risks and uncertainties, including those detailed in our filings with the SEC. Actual results, including, without limitation: (i) our
ability to develop and ultimately commercialize therapeutics, (ii) results from discussions with the FDA, or (iii) the application and
availability of corporate funds and our need for future funds. Such forward-looking statements also involve other factors, some of which
are outside of our control, which may cause our actual results, performance or achievements to materially differ from any future results,
performance, or achievements expressed or implied by such forward-looking statements and to fluctuate significantly. Such factors include,
among others:
| |
● |
acceptance
of our business model by investors and potential commercial collaborators; |
| |
|
|
| |
● |
our
future capital requirements and our ability to satisfy our capital needs; |
| |
|
|
| |
● |
our
ability to commence and complete required clinical trials of our product candidates and obtain approval from the FDA or other regulatory
agencies in different jurisdictions; |
| |
|
|
| |
● |
our
ability to secure and maintain key development and commercialization partners for our product candidates; |
| |
|
|
| |
● |
our
ability to obtain, maintain or protect the validity of our owned or licensed patents and other intellectual property; |
| |
|
|
| |
● |
our
ability to internally develop, acquire or license new inventions and intellectual property; |
| |
|
|
| |
● |
our
ability to retain key executive members; |
| |
|
|
| |
● |
interpretations
of current laws and the passages of future laws, rules and regulations applicable to our business; |
| |
|
|
| |
● |
the
outcome of current litigation; and |
| |
|
|
| |
● |
those
risk factors listed under Item 1A of our 2025 Annual Report and other factors detailed from time to time in our other filings with
the SEC. |
Although
management believes that the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no
assurance that the underlying assumptions will, in fact, prove to be correct or that actual future results will not be different from
the expectations expressed in this Report. We undertake no obligation to publicly update any forward-looking statements, whether as a
result of new information, future events or otherwise, except as required by applicable law.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
We
may from time to time become a party to various legal proceedings arising in the ordinary course of business. We are not currently the
subject of any pending legal proceedings other than the litigation that we initiated on March 30, 2026 relating to an executed securities
purchase agreement.
Item
1A. Risk Factors.
Investing
in our common stock is highly speculative and involves a high degree of risk. Before purchasing our common stock, you should carefully
consider the following risk factors, those risks included in “Part I, Item 1A, Risk Factors” in our 2025 Annual Report, together
with all of the other information contained in this Quarterly Report, including our unaudited condensed financial statements and the
related notes appearing elsewhere in this Quarterly Report.
Uncertainty
relating to the pending securities purchase agreement and related litigation could adversely affect our liquidity and business operations.
In
February 2026, we entered into a securities purchase agreement with an institutional investor providing for aggregate gross proceeds
of approximately $3.0 million. As of the date of this Quarterly Report, the transaction has not been consummated, and we have initiated
litigation relating to the investor’s alleged failure to fulfill its obligations under the agreement.
There
can be no assurance regarding the timing or outcome of the litigation, whether the transaction will ultimately close, or whether we will
receive any proceeds under the agreement. The uncertainty associated with the pending transaction and related legal proceedings may adversely
affect our liquidity, financial condition and ability to fund our operations and development activities. In addition, such uncertainty
may negatively impact our ability to obtain additional capital, enter into strategic transactions or maintain relationships with existing
and prospective investors, vendors and collaborators.
If
we are unable to obtain sufficient funding on acceptable terms, we may be required to delay, reduce or discontinue certain operational,
regulatory or development activities.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item
3. Defaults upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
During
the quarter ended March 31, 2026, no directors or officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934) of the
Company adopted or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,”
as each term is defined in Item 408(a) of Regulation S-K.
Item
6. Exhibits.
| Number |
|
Description |
| |
|
|
| 31.1 |
|
Certification of Chief Executive Officer Pursuant to Sarbanes-Oxley Section 302 |
| |
|
|
| 31.2 |
|
Certification of Interim Chief Financial Officer Pursuant to Sarbanes-Oxley Section 302 |
| |
|
|
| 32.1 |
|
Certification Pursuant To 18 U.S.C. Section 1350 (*) |
| |
|
|
| 32.2 |
|
Certification Pursuant To 18 U.S.C. Section 1350 (*) |
| |
|
|
| 101.ins |
|
XBRL
Instance Document |
| |
|
|
| 101.sch |
|
XBRL
Taxonomy Extension Schema Document |
| |
|
|
| 101.cal |
|
XBRL
Taxonomy Calculation Linkbase Document |
| |
|
|
| 101.def |
|
XBRL
Taxonomy Definition Linkbase Document |
| |
|
|
| 101.lab |
|
XBRL
Taxonomy Label Linkbase Document |
| |
|
|
| 101.pre |
|
XBRL
Taxonomy Presentation Linkbase Document |
| |
|
|
| 104 |
|
The
cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, formatted in Inline XBRL.
|
| |
|
|
| * |
|
A
signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company
and furnished to the Securities and Exchange Commission or its staff upon request. |
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.
| |
INHIBITOR
THERAPEUTICS, INC. |
| |
|
|
| Date:
May 15, 2026 |
By: |
/s/
Francis E. O’Donnell |
| |
|
Francis
E. O’Donnell |
| |
|
Chief
Executive Officer |
| |
|
(Principal
Executive Officer) |
| Date:
May 15, 2026 |
By: |
/s/
James A. McNulty |
| |
|
James
A. McNulty |
| |
|
Interim
Chief Financial Officer, Treasurer and Secretary |
| |
|
(Principal
Financial Officer) |