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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 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 001-13467
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.) |
|
|
|
900 West Platt St Suite 200
Tampa,
FL |
|
33606-2173 |
(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 August 6, 2024, there were 172,323,545 shares of company common stock issued and outstanding.
Inhibitor
Therapeutics, Inc.
Quarterly
Report on Form 10-Q
TABLE
OF CONTENTS
INHIBITOR
THERAPEUTICS, INC.
CONDENSED
BALANCE SHEETS
AS
OF JUNE 30, 2024 AND DECEMBER 31, 2023
| |
(Unaudited) June 30, 2024 | | |
December 31, 2023 | |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 7,098,742 | | |
$ | 8,839,912 | |
Prepaid expenses and other assets | |
| 74,625 | | |
| 109,243 | |
Total current assets | |
| 7,173,367 | | |
| 8,949,155 | |
Total assets | |
$ | 7,173,367 | | |
$ | 8,949,155 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 18,803 | | |
$ | 33,731 | |
Accrued expenses and other liabilities | |
| 16,724 | | |
| 631,433 | |
Total current liabilities | |
| 35,527 | | |
| 665,164 | |
Deferred revenue | |
| 3,000,000 | | |
| 3,000,000 | |
Total liabilities | |
| 3,035,527 | | |
| 3,665,164 | |
Commitments and contingencies (Note 5) | |
| — | | |
| — | |
Stockholders’ equity: | |
| | | |
| | |
Series A Preferred Stock, $0.0001 par value; 500,000 shares authorized; no shares issued and outstanding at June 30, 2024 and December 31, 2023 | |
| — | | |
| — | |
Series B Convertible, Redeemable, Preferred Stock, $0.0001 par value; 7,246,377 shares authorized; no shares issued and outstanding at June 30, 2024 and December 31, 2023 | |
| — | | |
| — | |
Undesignated Preferred Stock, $0.0001 par value; 2,253,623 shares authorized; no shares issued or outstanding at June 30, 2024 and December 31, 2023 | |
| — | | |
| — | |
Preferred Stock, value | |
| — | | |
| — | |
Common stock, $0.0001 par value; 500,000,000 shares authorized; 172,323,545 and 172,023,545 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | |
| 17,232 | | |
| 17,202 | |
Additional paid-in capital | |
| 54,087,065 | | |
| 54,046,845 | |
Accumulated deficit | |
| (49,966,457 | ) | |
| (48,780,056 | ) |
Total stockholders’ equity | |
| 4,137,840 | | |
| 5,283,991 | |
Total liabilities and stockholders’ equity | |
$ | 7,173,367 | | |
$ | 8,949,155 | |
See
notes to condensed financial statements
INHIBITOR
THERAPEUTICS, INC.
CONDENSED
STATEMENTS OF OPERATIONS
FOR
THE THREE-MONTH AND SIX-MONTH PERIODS 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: | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
Expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 239,776 | | |
| 233,993 | | |
| 475,135 | | |
| 435,391 | |
General and administrative | |
| 345,371 | | |
| 508,468 | | |
| 884,829 | | |
| 936,794 | |
Total expenses | |
| 585,147 | | |
| 742,461 | | |
| 1,359,964 | | |
| 1,372,185 | |
Loss from operations | |
| (585,147 | ) | |
| (742,461 | ) | |
| (1,359,964 | ) | |
| (1,372,185 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income: | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 83,457 | | |
| 87,940 | | |
| 173,563 | | |
| 178,068 | |
Net loss | |
$ | (501,690 | ) | |
$ | (654,521 | ) | |
$ | (1,186,401 | ) | |
$ | (1,194,117 | ) |
Basic and diluted net loss per share | |
$ | (0.00 | ) | |
$ | (0.00 | ) | |
$ | (0.01 | ) | |
$ | (0.01 | ) |
Weighted average common stock shares outstanding – basic and diluted | |
| 172,323,545 | | |
| 171,968,134 | | |
| 172,201,567 | | |
| 171,881,117 | |
See
notes to condensed financial statements
INHIBITOR
THERAPEUTICS, INC.
CONDENSED
STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balances, January 1, 2024 | |
| 172,023,545 | | |
$ | 17,202 | | |
$ | 54,046,845 | | |
$ | (48,780,056 | ) | |
$ | 5,283,991 | |
Issuance of common stock under equity incentive plan | |
| 300,000 | | |
| 30 | | |
| 20,970 | | |
| — | | |
| 21,000 | |
Stock-based compensation | |
| — | | |
| — | | |
| 18,090 | | |
| — | | |
| 18,090 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (684,711 | ) | |
| (684,711 | ) |
Balances, March 31, 2024 | |
| 172,323,545 | | |
$ | 17,232 | | |
$ | 54,085,905 | | |
$ | (49,464,767 | ) | |
$ | 4,638,370 | |
Stock-based compensation | |
| — | | |
| — | | |
| 1,160 | | |
| — | | |
| 1,160 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (501,690 | ) | |
| (501,690 | ) |
Balances, June 30, 2024 | |
| 172,323,545 | | |
$ | 17,232 | | |
$ | 54,087,065 | | |
$ | (49,966,457 | ) | |
$ | 4,137,840 | |
| |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balances, January 1, 2023 | |
| 171,793,134 | | |
$ | 17,179 | | |
$ | 54,033,084 | | |
$ | (45,753,921 | ) | |
$ | 8,296,342 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (539,596 | ) | |
| (539,596 | ) |
Balances, March 31, 2023 | |
| 171,793,134 | | |
$ | 17,179 | | |
$ | 54,033,084 | | |
$ | (46,293,517 | ) | |
$ | 7,756,746 | |
Beginning balance | |
| 171,793,134 | | |
$ | 17,179 | | |
$ | 54,033,084 | | |
$ | (46,293,517 | ) | |
$ | 7,756,746 | |
Issuance of common stock under equity incentive plan | |
| 175,000 | | |
| 18 | | |
| 12,232 | | |
| — | | |
| 12,250 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (654,521 | ) | |
| (654,521 | ) |
Balances, June 30, 2023 | |
| 171,968,134 | | |
$ | 17,197 | | |
$ | 54,045,316 | | |
$ | (46,948,038 | ) | |
$ | 7,114,475 | |
Ending balance | |
| 171,968,134 | | |
$ | 17,197 | | |
$ | 54,045,316 | | |
$ | (46,948,038 | ) | |
$ | 7,114,475 | |
See
notes to condensed financial statements
INHIBITOR
THERAPEUTICS, 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 | |
Operating activities: | |
| | | |
| | |
Net loss | |
$ | (1,186,401 | ) | |
$ | (1,194,117 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Stock-based compensation | |
| 40,250 | | |
| 12,250 | |
Changes in assets and liabilities: | |
| | | |
| | |
Prepaid expenses | |
| 34,618 | | |
| (34,107 | ) |
Accounts payable and other current liabilities | |
| (629,637 | ) | |
| (223,923 | ) |
Net cash used in operating activities | |
| (1,741,170 | ) | |
| (1,439,897 | ) |
Financing activities: | |
| | | |
| | |
Payments made on notes payable | |
| — | | |
| (411,000 | ) |
Net cash used in financing activities | |
| — | | |
| (411,000 | ) |
Net change in cash and cash equivalents | |
| (1,741,170 | ) | |
| (1,850,897 | ) |
Cash and cash equivalents at beginning of period | |
| 8,839,912 | | |
| 11,951,224 | |
Cash and cash equivalents at end of period | |
$ | 7,098,742 | | |
$ | 10,100,327 | |
See
notes to condensed financial statements
INHIBITOR
THERAPEUTICS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
1.
Corporate Overview
Overview
Inhibitor
Therapeutics, Inc., a Delaware corporation (the “Company”, “INTI”, “we”, “us” or similar
terminology), is 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. The Company also has explored and expects to continue to explore acquiring
or licensing other innovative pre-clinical and clinical stage therapeutics addressing unmet needs for the treatment of cancer and other
diseases based on repurposing active ingredients of already approved drugs.
The
accompanying unaudited condensed financial statements of the Company have been prepared without audit. In the opinion of management,
all adjustments (which include normal recurring adjustments) necessary to present fairly the financial position, results of operations
and cash flows as of June 30, 2024, 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, 2023, which are included in the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the SEC on March 29, 2024 (the “2023 Annual
Report”). The accompanying condensed balance sheet as of December 31, 2023 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-month and six-month period ended June 30, 2024, 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 2023 Annual Report and the Company’s other filings with the
SEC.
Nature
of the Business
The
Company’s current primary focus is on the development of therapies initially for basal cell carcinoma (“BCC”), prostate
and lung cancers in the United States utilizing itraconazole, a drug currently approved by the U.S. Food and Drug Administration (“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.
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.
During
the six months ended June 30, 2024, the Company formally requested a Type-B, pre-investigational new drug application (“pre-IND”)
meeting with the FDA to obtain feedback on the overall drug development and regulatory plan to use itraconazole for the treatment of
BCC tumors in BCCNS patients, for which the Company has engaged the services of external experts in the field to assist with the process.
The Company’s Phase 2b clinical study (HP2001) uses a novel formulation of itraconazole, which is referenced in the pre-IND submission.
The Company was granted a meeting with the Dermatology Division of the FDA, which the Company subsequently cancelled (with acknowledgment
from the FDA), as the Company believes the pre-IND meeting is more ideally suited for the Oncology Division of the FDA. As such, the
Company is currently pursuing an in-person meeting with the Oncology Division of the FDA.
INHIBITOR
THERAPEUTICS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
2.
Liquidity and Management’s Plans
The
Company is presently focused on its business plan of developing and ultimately commercializing innovative therapeutics based on already
approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery. The Company expects to progress
with the FDA during 2024 to reach a conclusion on whether any additional clinical trials are required before submitting a New Drug Application
(“NDA”). The current cash on hand, approximately $7.1 million as of June 30, 2024, is sufficient to continue to execute the
Company’s business plan as currently anticipated, assuming the receipt of favorable guidance from the FDA such that additional
clinical trials will not be required. Based on the current operational plan and budget, the Company expects to have sufficient cash over
the next 12 months to manage its business and continue to pursue other drug development opportunities, as needed. As capital requirements
for additional opportunities are determined, or additional clinical trials, the Company will consider raising additional capital in the
public market.
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. Miscellaneous 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 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 June 30, 2024 and December 31, 2023, deferred revenue
consisted of $3.0 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 with an original maturity of three months or less to be cash equivalents. At times,
the Company may maintain 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.
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 SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(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. Penalties and interest assessed as a result of unresolved tax liabilities
are also classified as G&A expenses.
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.
Management
has evaluated the guidance relating to accounting for uncertainty in income taxes and has determined that the Company had no uncertain
income tax positions that could have a significant effect on the financial statements as of June 30, 2024.
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.
INHIBITOR
THERAPEUTICS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
4.
Stockholders’ Equity
Employee
Stock Plans
During
the six months ended June 30, 2024, the Company granted 300,000 restricted shares of common stock with an aggregate grant date fair value
of approximately $0.02 million to the members of our Board of Directors under the equity incentive plan. During the six months ended
June 30, 2023, the Company granted 175,000 restricted shares of common stock with an aggregate grant date fair value of approximately
$0.01 million to the members of our Board of Directors under the equity incentive plan. The shares of common stock were fully vested
upon issuance but are restricted from trading for a period of one year from the date of grant.
During
the six months ended June 30, 2024, the Company issued 290,000 common stock options with an exercise price of $0.08 per share and a weighted-average
grant date fair value of $0.07 per share. The aggregate fair value of the options issued was approximately $0.02 million, as determined
by using the Black-Scholes valuation model. The weighted-average assumptions used to estimate the fair value of the options issued during
the period were as follows: risk-free interest rate: 4.33%; expected term: 5 years; expected volatility: 129.18%; and no dividend yield.
The options are fully vested upon issuance and the contractual terms expire in 2034.
As
of June 30, 2024, there were 2,865,646 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 June 30, 2024. 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 June 30, 2024
were 5.7 years, $0.09 and approximately $0.07 million, respectively.
5.
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 pending legal proceedings.
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 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 also have explored and expect to continue to explore acquiring or licensing
other innovative pre-clinical and clinical stage therapeutics addressing unmet needs for the treatment of cancer and other diseases based
on repurposing active ingredients of already approved drugs.
Our
current primary focus is on the development of therapies initially for BCC, prostate and lung 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. The Company has 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 the Agreement, JHU granted 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, BCC including
basal cell carcinoma nevus syndrome (“BCCNS”), and lung cancer.
During
the six months ended June 30, 2024, we formally requested a Type-B, pre-investigational new drug application (“pre-IND”)
meeting with the FDA to obtain feedback on the overall drug development and regulatory plan to use itraconazole for the treatment of
BCC tumors in BCCNS patients, for which we have engaged the services of external experts in the field to assist with the process. Our
Phase 2b clinical study (HP2001) uses a novel formulation of itraconazole, which we reference in our pre-IND submission. We were granted
a meeting with the Dermatology Division of the FDA, which we subsequently cancelled (with acknowledgment from the FDA), as we believe
the pre-IND meeting is more ideally suited for the Oncology Division of the FDA. As such, we are currently pursuing an in-person meeting
with the Oncology Division of the FDA.
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 2023 Annual Report.
Results
of Operations
For
the three months ended June 30, 2024 compared to the three months ended June 30, 2023
Research
and Development Expenses. We incurred $0.2 million of research and development expenses during each of the three months ended June
30, 2024 and June 30, 2023. 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 and remained consistent quarter-over-quarter.
We expect research and development expenses to increase in the future, depending on the results from our upcoming FDA meeting.
General
and Administrative Expenses. We incurred approximately $0.3 million and $0.5 million in general and administrative expenses during
the three months ended June 30, 2024 and June 30, 2023, respectively. During the three months ended June 30, 2024, general and administrative
expenses were composed primarily of compensation costs of $0.2 million and insurance costs of $0.1 million. The decrease in general and
administrative expenses of approximately $0.2 million is primarily due to reductions in the fees incurred for professional services.
Interest
income. We earned approximately $0.1 million of interest income during each of the three months
ended June 30, 2024 and June 30, 2023. The interest income is generated from deposits held in our depository accounts.
For
the six months ended June 30, 2024 compared to the six months ended June 30, 2023
Research
and Development Expenses. We incurred $0.5 million and $0.4 million of research and development expenses during the six months ended
June 30, 2024 and June 30, 2023, 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 and remained consistent
with the prior year-to-date period. The increase in research and development expenses is the result of the necessary costs to support
the incremental R&D activity during the current year. We expect research and development expenses will continue to increase in the
future, depending on the results from our upcoming FDA meeting.
General
and Administrative Expenses. We incurred approximately $0.9 million in general and administrative expenses during each of the six
months ended June 30, 2024 and June 30, 2023. During the six months ended June 30, 2024, general and administrative expenses are composed
primarily of compensation costs of $0.5 million, insurance costs of $0.2 million and professional services fees of $0.2 million. The
slight decrease in general and administrative expenses is primarily due to variables in other operating expenses categories.
Interest
income. We earned approximately $0.2 million of interest income during each of the six months
ended June 30, 2024 and June 30, 2023. The interest income is generated from deposits held in our depository accounts.
Liquidity
and Capital Resources
We
are presently focused on our business plan of developing and ultimately commercializing innovative therapeutics based on already approved
active pharmaceuticals that have patent-protected methods of use and/or methods of delivery. We expect to progress with the FDA during
2024 to reach a conclusion on whether any additional clinical trials are required before submitting our New Drug Application (NDA). Our
current cash on hand, approximately $7.1 million as of June 30, 2024, is sufficient to continue to execute our business plan as currently
anticipated, assuming we get favorable guidance from the FDA such that we do not require additional clinical trials. Based on our current
operational plan and budget, we expect that we will have sufficient cash to manage our business and continue to pursue other drug development
opportunities, as needed. As capital requirements for additional opportunities are determined, or additional clinical trials, we will
consider raising additional capital in the public market.
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 second fiscal quarter of 2024 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; and |
|
|
|
|
● |
those
risk factors listed under Item 1A of our 2023 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
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 pending legal proceedings.
Item
1A. Risk Factors.
Not
required for smaller reporting companies.
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.
Not
applicable.
Item
6. Exhibits.
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:
August 6, 2024 |
By: |
/s/
Francis E. O’Donnell |
|
|
Francis
E. O’Donnell
Chief
Executive Officer
(Principal
Executive Officer) |
|
|
|
Date:
August 6, 2024 |
By: |
/s/
James A. McNulty |
|
|
James
A. McNulty
Interim
Chief Financial Officer, Treasurer and Secretary
(Principal
Financial Officer) |
Exhibit
31.1
Certification
of Chief Executive Officer
Pursuant
to Rule 13a-14(a)
I,
Francis E. O’Donnell, certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q of Inhibitor Therapeutics, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries as applicable, is made known
to us by others within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
August 6, 2024
/s/
Francis E. O’Donnell |
|
Francis
E. O’Donnell |
|
Chief
Executive Officer |
|
Exhibit
31.2
Certification
of Interim Chief Financial Officer
Pursuant
to Rule 13a-14(a)
I,
James A. McNulty, certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q of Inhibitor Therapeutics, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries as applicable, is made known
to us by others within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
August 6, 2024
/s/
James A. McNulty |
|
James
A. McNulty |
|
Interim
Chief Financial Officer, Treasurer and Secretary |
|
Exhibit
32.1
INHIBITOR
THERAPEUTICS, INC.
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Inhibitor Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ending June
30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Francis E. O’Donnell,
Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. ss.1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002, that to my knowledge:
(1)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of
the Company.
/s/
Francis E. O’Donnell |
|
Francis
E. O’Donnell |
|
Chief
Executive Officer |
|
August
6, 2024 |
|
Exhibit
32.2
INHIBITOR
THERAPEUTICS, INC.
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Inhibitor Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ending June
30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, James A. McNulty, Interim
Chief Financial Officer, Treasurer and Secretary of the Company, certify, pursuant to 18 U.S.C. ss.1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
(1)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of
the Company.
/s/
James A. McNulty |
|
James
A. Mcnulty |
|
Interim
Chief Financial Officer, Treasurer and Secretary |
|
August
6, 2024 |
|
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v3.24.2.u1
Condensed Balance Sheets - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 7,098,742
|
$ 8,839,912
|
Prepaid expenses and other assets |
74,625
|
109,243
|
Total current assets |
7,173,367
|
8,949,155
|
Total assets |
7,173,367
|
8,949,155
|
Current liabilities: |
|
|
Accounts payable |
18,803
|
33,731
|
Accrued expenses and other liabilities |
16,724
|
631,433
|
Total current liabilities |
35,527
|
665,164
|
Deferred revenue |
3,000,000
|
3,000,000
|
Total liabilities |
3,035,527
|
3,665,164
|
Commitments and contingencies (Note 5) |
|
|
Stockholders’ equity: |
|
|
Common stock, $0.0001 par value; 500,000,000 shares authorized; 172,323,545 and 172,023,545 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively |
17,232
|
17,202
|
Additional paid-in capital |
54,087,065
|
54,046,845
|
Accumulated deficit |
(49,966,457)
|
(48,780,056)
|
Total stockholders’ equity |
4,137,840
|
5,283,991
|
Total liabilities and stockholders’ equity |
7,173,367
|
8,949,155
|
Series A Preferred Stock [Member] |
|
|
Stockholders’ equity: |
|
|
Preferred Stock, value |
|
|
Series B Convertible Preferred Stock [Member] |
|
|
Stockholders’ equity: |
|
|
Preferred Stock, value |
|
|
Undesignated Preferred Stock [Member] |
|
|
Stockholders’ equity: |
|
|
Preferred Stock, value |
|
|
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v3.24.2.u1
Condensed Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
500,000,000
|
500,000,000
|
Common stock, shares issued |
172,323,545
|
172,023,545
|
Common stock, shares outstanding |
172,323,545
|
172,023,545
|
Series A Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
500,000
|
500,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Series B Convertible Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
7,246,377
|
7,246,377
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Undesignated Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
2,253,623
|
2,253,623
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Condensed Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenues: |
|
|
|
|
Expenses: |
|
|
|
|
Research and development |
239,776
|
233,993
|
475,135
|
435,391
|
General and administrative |
345,371
|
508,468
|
884,829
|
936,794
|
Total expenses |
585,147
|
742,461
|
1,359,964
|
1,372,185
|
Loss from operations |
(585,147)
|
(742,461)
|
(1,359,964)
|
(1,372,185)
|
Other income: |
|
|
|
|
Interest income |
83,457
|
87,940
|
173,563
|
178,068
|
Net loss |
$ (501,690)
|
$ (654,521)
|
$ (1,186,401)
|
$ (1,194,117)
|
Basic net loss per share |
$ (0.00)
|
$ (0.00)
|
$ (0.01)
|
$ (0.01)
|
Diluted net loss per share |
$ (0.00)
|
$ (0.00)
|
$ (0.01)
|
$ (0.01)
|
Weighted average common stock shares outstanding - basic |
172,323,545
|
171,968,134
|
172,201,567
|
171,881,117
|
Weighted average common stock shares outstanding - diluted |
172,323,545
|
171,968,134
|
172,201,567
|
171,881,117
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.24.2.u1
Condensed Statements of Stockholders' Equity (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Beginning balance at Dec. 31, 2022 |
$ 17,179
|
$ 54,033,084
|
$ (45,753,921)
|
$ 8,296,342
|
Beginning balance, shares at Dec. 31, 2022 |
171,793,134
|
|
|
|
Net loss |
|
|
(539,596)
|
(539,596)
|
Ending balance at Mar. 31, 2023 |
$ 17,179
|
54,033,084
|
(46,293,517)
|
7,756,746
|
Ending balance, shares at Mar. 31, 2023 |
171,793,134
|
|
|
|
Beginning balance at Dec. 31, 2022 |
$ 17,179
|
54,033,084
|
(45,753,921)
|
8,296,342
|
Beginning balance, shares at Dec. 31, 2022 |
171,793,134
|
|
|
|
Net loss |
|
|
|
(1,194,117)
|
Ending balance at Jun. 30, 2023 |
$ 17,197
|
54,045,316
|
(46,948,038)
|
7,114,475
|
Ending balance, shares at Jun. 30, 2023 |
171,968,134
|
|
|
|
Beginning balance at Mar. 31, 2023 |
$ 17,179
|
54,033,084
|
(46,293,517)
|
7,756,746
|
Beginning balance, shares at Mar. 31, 2023 |
171,793,134
|
|
|
|
Issuance of common stock under equity incentive plan |
$ 18
|
12,232
|
|
12,250
|
Issuance of common stock under equity incentive plan, shares |
175,000
|
|
|
|
Net loss |
|
|
(654,521)
|
(654,521)
|
Ending balance at Jun. 30, 2023 |
$ 17,197
|
54,045,316
|
(46,948,038)
|
7,114,475
|
Ending balance, shares at Jun. 30, 2023 |
171,968,134
|
|
|
|
Beginning balance at Dec. 31, 2023 |
$ 17,202
|
54,046,845
|
(48,780,056)
|
5,283,991
|
Beginning balance, shares at Dec. 31, 2023 |
172,023,545
|
|
|
|
Issuance of common stock under equity incentive plan |
$ 30
|
20,970
|
|
21,000
|
Issuance of common stock under equity incentive plan, shares |
300,000
|
|
|
|
Stock-based compensation |
|
18,090
|
|
18,090
|
Net loss |
|
|
(684,711)
|
(684,711)
|
Ending balance at Mar. 31, 2024 |
$ 17,232
|
54,085,905
|
(49,464,767)
|
4,638,370
|
Ending balance, shares at Mar. 31, 2024 |
172,323,545
|
|
|
|
Beginning balance at Dec. 31, 2023 |
$ 17,202
|
54,046,845
|
(48,780,056)
|
5,283,991
|
Beginning balance, shares at Dec. 31, 2023 |
172,023,545
|
|
|
|
Net loss |
|
|
|
(1,186,401)
|
Ending balance at Jun. 30, 2024 |
$ 17,232
|
54,087,065
|
(49,966,457)
|
4,137,840
|
Ending balance, shares at Jun. 30, 2024 |
172,323,545
|
|
|
|
Beginning balance at Mar. 31, 2024 |
$ 17,232
|
54,085,905
|
(49,464,767)
|
4,638,370
|
Beginning balance, shares at Mar. 31, 2024 |
172,323,545
|
|
|
|
Stock-based compensation |
|
1,160
|
|
1,160
|
Net loss |
|
|
(501,690)
|
(501,690)
|
Ending balance at Jun. 30, 2024 |
$ 17,232
|
$ 54,087,065
|
$ (49,966,457)
|
$ 4,137,840
|
Ending balance, shares at Jun. 30, 2024 |
172,323,545
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for restricted stock unit under share-based payment arrangement.
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v3.24.2.u1
Condensed Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Operating activities: |
|
|
|
|
|
|
Net loss |
$ (501,690)
|
$ (684,711)
|
$ (654,521)
|
$ (539,596)
|
$ (1,186,401)
|
$ (1,194,117)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
40,250
|
12,250
|
Changes in assets and liabilities: |
|
|
|
|
|
|
Prepaid expenses |
|
|
|
|
34,618
|
(34,107)
|
Accounts payable and other current liabilities |
|
|
|
|
(629,637)
|
(223,923)
|
Net cash used in operating activities |
|
|
|
|
(1,741,170)
|
(1,439,897)
|
Financing activities: |
|
|
|
|
|
|
Payments made on notes payable |
|
|
|
|
|
(411,000)
|
Net cash used in financing activities |
|
|
|
|
|
(411,000)
|
Net change in cash and cash equivalents |
|
|
|
|
(1,741,170)
|
(1,850,897)
|
Cash and cash equivalents at beginning of period |
|
$ 8,839,912
|
|
$ 11,951,224
|
8,839,912
|
11,951,224
|
Cash and cash equivalents at end of period |
$ 7,098,742
|
|
$ 10,100,327
|
|
$ 7,098,742
|
$ 10,100,327
|
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v3.24.2.u1
Corporate Overview
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Corporate Overview |
1.
Corporate Overview
Overview
Inhibitor
Therapeutics, Inc., a Delaware corporation (the “Company”, “INTI”, “we”, “us” or similar
terminology), is 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. The Company also has explored and expects to continue to explore acquiring
or licensing other innovative pre-clinical and clinical stage therapeutics addressing unmet needs for the treatment of cancer and other
diseases based on repurposing active ingredients of already approved drugs.
The
accompanying unaudited condensed financial statements of the Company have been prepared without audit. In the opinion of management,
all adjustments (which include normal recurring adjustments) necessary to present fairly the financial position, results of operations
and cash flows as of June 30, 2024, 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, 2023, which are included in the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the SEC on March 29, 2024 (the “2023 Annual
Report”). The accompanying condensed balance sheet as of December 31, 2023 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-month and six-month period ended June 30, 2024, 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 2023 Annual Report and the Company’s other filings with the
SEC.
Nature
of the Business
The
Company’s current primary focus is on the development of therapies initially for basal cell carcinoma (“BCC”), prostate
and lung cancers in the United States utilizing itraconazole, a drug currently approved by the U.S. Food and Drug Administration (“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.
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.
During
the six months ended June 30, 2024, the Company formally requested a Type-B, pre-investigational new drug application (“pre-IND”)
meeting with the FDA to obtain feedback on the overall drug development and regulatory plan to use itraconazole for the treatment of
BCC tumors in BCCNS patients, for which the Company has engaged the services of external experts in the field to assist with the process.
The Company’s Phase 2b clinical study (HP2001) uses a novel formulation of itraconazole, which is referenced in the pre-IND submission.
The Company was granted a meeting with the Dermatology Division of the FDA, which the Company subsequently cancelled (with acknowledgment
from the FDA), as the Company believes the pre-IND meeting is more ideally suited for the Oncology Division of the FDA. As such, the
Company is currently pursuing an in-person meeting with the Oncology Division of the FDA.
INHIBITOR
THERAPEUTICS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
|
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- DefinitionThe entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.24.2.u1
Liquidity and Management’s Plans
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Liquidity and Management’s Plans |
2.
Liquidity and Management’s Plans
The
Company is presently focused on its business plan of developing and ultimately commercializing innovative therapeutics based on already
approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery. The Company expects to progress
with the FDA during 2024 to reach a conclusion on whether any additional clinical trials are required before submitting a New Drug Application
(“NDA”). The current cash on hand, approximately $7.1 million as of June 30, 2024, is sufficient to continue to execute the
Company’s business plan as currently anticipated, assuming the receipt of favorable guidance from the FDA such that additional
clinical trials will not be required. Based on the current operational plan and budget, the Company expects to have sufficient cash over
the next 12 months to manage its business and continue to pursue other drug development opportunities, as needed. As capital requirements
for additional opportunities are determined, or additional clinical trials, the Company will consider raising additional capital in the
public market.
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v3.24.2.u1
Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
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. Miscellaneous 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 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 June 30, 2024 and December 31, 2023, deferred revenue
consisted of $3.0 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 with an original maturity of three months or less to be cash equivalents. At times,
the Company may maintain 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.
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 SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(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. Penalties and interest assessed as a result of unresolved tax liabilities
are also classified as G&A expenses.
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.
Management
has evaluated the guidance relating to accounting for uncertainty in income taxes and has determined that the Company had no uncertain
income tax positions that could have a significant effect on the financial statements as of June 30, 2024.
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.
INHIBITOR
THERAPEUTICS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
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v3.24.2.u1
Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Stockholders’ Equity |
4.
Stockholders’ Equity
Employee
Stock Plans
During
the six months ended June 30, 2024, the Company granted 300,000 restricted shares of common stock with an aggregate grant date fair value
of approximately $0.02 million to the members of our Board of Directors under the equity incentive plan. During the six months ended
June 30, 2023, the Company granted 175,000 restricted shares of common stock with an aggregate grant date fair value of approximately
$0.01 million to the members of our Board of Directors under the equity incentive plan. The shares of common stock were fully vested
upon issuance but are restricted from trading for a period of one year from the date of grant.
During
the six months ended June 30, 2024, the Company issued 290,000 common stock options with an exercise price of $0.08 per share and a weighted-average
grant date fair value of $0.07 per share. The aggregate fair value of the options issued was approximately $0.02 million, as determined
by using the Black-Scholes valuation model. The weighted-average assumptions used to estimate the fair value of the options issued during
the period were as follows: risk-free interest rate: 4.33%; expected term: 5 years; expected volatility: 129.18%; and no dividend yield.
The options are fully vested upon issuance and the contractual terms expire in 2034.
As
of June 30, 2024, there were 2,865,646 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 June 30, 2024. 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 June 30, 2024
were 5.7 years, $0.09 and approximately $0.07 million, respectively.
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v3.24.2.u1
Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Estimates |
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 |
Revenue
Recognition
The
Company currently has no ongoing source of revenue. Miscellaneous 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 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 June 30, 2024 and December 31, 2023, deferred revenue
consisted of $3.0 million of royalties advanced by Mayne Pharma under the Third Amended Supply and License Agreement (“SLA”).
|
Cash and Cash Equivalents |
Cash
and Cash Equivalents
The
Company considers all highly liquid debt instruments with an original maturity of three months or less to be cash equivalents. At times,
the Company may maintain 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.
|
Research and Development Expenses |
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 SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
|
General and Administrative Expenses |
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. Penalties and interest assessed as a result of unresolved tax liabilities
are also classified as G&A expenses.
|
Stock-Based Compensation |
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 |
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.
Management
has evaluated the guidance relating to accounting for uncertainty in income taxes and has determined that the Company had no uncertain
income tax positions that could have a significant effect on the financial statements as of June 30, 2024.
|
Recent accounting pronouncements |
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.
|
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Stockholders’ Equity (Details Narrative) - USD ($)
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Grant date fair value |
$ 20,000.00
|
|
Shares issued |
290,000
|
|
Exercise price per share |
$ 0.08
|
|
Grant date fair value |
$ 0.07
|
|
Risk free interest rate |
4.33%
|
|
Expected term |
5 years
|
|
Expected volatility |
129.18%
|
|
Dividend yield |
$ 0
|
|
Equity Incentive Plan [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Issuance of common stock under equity incentive plan, shares |
300,000
|
175,000
|
Grant date fair value |
$ 20,000.00
|
$ 10,000.00
|
Number of outstanding common stock options |
2,865,646
|
|
Vesting rights, percentage |
100.00%
|
|
Options, weighted average remaining contractual life |
5 years 8 months 12 days
|
|
Options, weighted average exercise price per share |
$ 0.09
|
|
Aggregate intrinsic value outstanding common stock options |
$ 70,000.00
|
|
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Inhibitor Therapeutics (QB) (USOTC:INTI)
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