☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Delaware		30-0793665
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)
449 South 12 th   Street , Unit 1705 Tampa, FL		33602
(Address of principal executive offices)		(Zip Code)

Large accelerated filer		☐		Accelerated filer		☐
Non-accelerated filer		☒		Smaller reporting company		☒
				Emerging growth company		☐

				Page
Part I. Financial Information
Item 1.		Condensed Financial Statements (unaudited)
		Condensed Balance Sheets as of June 30, 2021 and December 31, 2020			1
		Condensed Statements of Operations for the three months and six months ended June 30, 2021 and 2020			2
		Condensed Statement of Stockholders’ Equity (Deficit) for the three and six months ended June 30, 2021 and 2020			3
		Condensed Statements of Cash Flows for the six months ended June 30, 2021 and 2020			4
		Notes to Condensed Financial Statements			5
Item 2.		Management’s Discussion and Analysis of Financial Condition and Results of Operations			11
Item 3.		Quantitative and Qualitative Disclosures about Market Risk			12
Item 4.		Controls and Procedures			12
Cautionary Note on Forward Looking Statements					13
Part II. Other Information
Item 1		Legal Proceedings			14
Item 1A.		Risk Factors			14
Item 2		Unregistered Sales of Equity Securities and Use of Proceeds			14
Item 3		Defaults upon Senior Securities			14
Item 4		Mine Safety Disclosures			15
Item 5		Other Information			15
Item 6.		Exhibits			15
Signatures					S-1

		(Unaudited) June 30, 2021				December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents		$	93,716			$	75,059
Prepaid expenses			33,042				32,292
Total current assets			126,758				107,351
Other long-term assets			9,762				24,408
Total assets		$	136,520			$	131,759
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable		$	300,073			$	269,416
Interest payable, related party			5,358				—
Dividends payable, related party			99,178				100,822
Note payable, short-term  (PPP Loan)			—				30,044
Term debt facility, short-term, related party			134,750				—
Other liabilities			15,500				25,124
Total current liabilities			554,859				425,406
Note payable, long-term (PPP Loan)			—				11,556
Term debt facility , long-term, related party			96,250				55,000
Deferred revenue, related party			3,000,000				3,000,000
Total liabilities			3,651,109				3.491,962
Commitments and contingencies (Note 7)			—				—
Stockholders’ deficit:
Series A Preferred Stock, $0.0001 par value; 500,000 shares authorized; no shares issued and outstanding			—				—
Series B Convertible, Redeemable, Preferred Stock, $0.0001 par value; 7,246,377 shares authorized; 5,797,102 shares issued and outstanding at June 30, 2021 and December 31, 2020			3,960,866				3,960,866
Undesignated Preferred Stock, $0.0001 par value; 2,253,623 shares authorized; no shares issued or outstanding			—				—
Common stock, $0.0001 par value; 500,000,000 shares authorized; 375,876,361 and 373,635,873 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively			37,588				37,364
Additional paid-in capital			49,952,631				49,814,043
Accumulated deficit			(57,465,674	)			(57,172,476	)
Total stockholders’ deficit			(3,514,589	)			(3,360,203	)
Total liabilities and stockholders’ deficit		$	136,520			$	131,759

		Three Months Ended June 30,								Six Months Ended June 30,
		2021				2020				2021				2020
Revenues:		$	—			$	—			$	—			$	—
Expenses:
Research and development			950				52,661				4,830				150,116
General and administrative			61,685				262,383				225,558				550,370
Total Expenses:			62,635				315,044				230,388				700,486
Loss from operations			(62,635	)			(315,044	)			(230,388	)			(700,486	)
Interest income			—				150				—				1,175
Interest expense, related party			(3,547	)			—				(5,232	)			—
Gain on loan forgiveness			—				—				41,600				—
Net loss			(66,182	)			(314,894	)			(194,020	)			(699,311	)
Preferred stock dividend			(49,863	)			(49,863	)			(99,178	)			(99,726	)
Net loss applicable to common stockholders		$	(116,045	)		$	(364,757	)		$	(293,198	)		$	(799,037	)
Basic and diluted net loss applicable to common stockholders per share		$	(0.00	)		$	(0.00	)		$	(0.00	)		$	(0.00	)
Weighted average common stock shares outstanding – basic and diluted			375,876,361				370,446,185				375,703,064				370,446,185

		Preferred Stock – Series B								Common Stock								Additional Paid-In Capital				Accumulated Deficit				Total Stockholders’ Equity
		Shares				Amount				Shares				Amount
Balances, January 1, 2021			5,797,102			$	3,960,866				373,635,873			$	37,364			$	49,814,043			$	(57,172,476	)		$	(3,360,203	)
Common shares issued in payment of Preferred Stock dividend, related party			—				—				2,240,488				224				100,598				—				100,822
Stock based compensation			—				—				—				—				37,990				—				37,990
Preferred stock dividends, related party			—				—				—				—				—				(49,315	)			(49,315	)
Net loss			—				—				—				—				—				(127,838	)			(127,838	)
March 31, 2021			5,797,102			$	3,960,866				375,876,361			$	37,588			$	49,952,631			$	(57,349,629	)		$	(3,398,544	)
Preferred stock dividends, related party			—				—				—				—				—				(49,863	)			(49,863	)
Net loss			—				—				—				—				—				(66,182	)			(66,182	)
Balances, June 30, 2021			5,797,102			$	3,960,866				375,876,361			$	37,588			$	49,952,631			$	(57,465,674	)		$	(3,514,589	)
		Preferred Stock – Series B								Common Stock								Additional Paid-In Capital				Accumulated Deficit				Total Stockholders’ Equity
		Shares				Amount				Shares				Amount
Balances, January 1, 2020			5,797,102			$	3,960,866				370,446,185			$	37,045			$	49,384,953			$	(55,913,999	)		$	(2,531,135	)
Stock based compensation			—				—				—				—				16,819				—				16,819
Preferred stock dividends, related party			—				—				—				—				—				(49,863	)			(49,863	)
Net loss			—				—				—				—				—				(384,417	)			(384,417	)
Balance March 31, 2020			5,797,102			$	3,960,866				370,446,185			$	37,045			$	49,401,772			$	(56,348,279	)		$	(2,948,596	)
Stock based compensation			—				—				—				—				42,753				—				42,753
Preferred stock dividends			—				—				—				—				—				(49,863	)			(49,863	)
Net loss			—				—				—				—				—				(314,894	)			(314,894	)
Balances, June 30, 2020			5,797,102			$	3,960,866				370,446,185			$	37,045			$	49,444,525			$	(56,713,036	)		$	(3,270,600	)

		Six Months Ended June 30,
		2021				2020
Operating activities:
Net loss		$	(194,020	)		$	(699,311	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock based compensation			37,990				59,572
Gain on loan forgiveness			(41,600	)			—
Changes in assets and liabilities:
Prepaid expense and other assets			13,896				17,067
Accounts payable and other current liabilities			26,391				(85,427	)
Net cash used in operating activities			(157,343	)			(708,099	)
Financing activities:
Proceeds from note payable (Note 4)			—				41,600
Proceeds from term debt facility, related party			176,000				—
Net cash provided by financing activities			176,000				41,600
Net change in cash and cash equivalents			18,657				(666,499	)
Cash and cash equivalents at beginning of period			75,059				803,816
Cash and cash equivalents at end of period		$	93,716			$	137,317
Non-cash financing activities:
Issuance of common stock for payment of Preferred Stock dividend		$	100,822			$	—
Accrued, but unpaid dividends		$	99,178			$	99,726

1.	Corporate overview:

Overview

The accompanying unaudited condensed financial statements of Inhibitor Therapeutics, Inc., a Delaware corporation (the “Company”, “INTI”, “we”, “us” or similar terminology), have been prepared by the Company 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, 2021, 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, 2020, which are included in the Company’s Annual Report on Form

10-K

for the fiscal year ended December 31, 2020, which was filed with the SEC on March 26, 2021 (the “2020 Annual Report”). The accompanying condensed balance sheet as of December 31, 2020 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

six-month

period ended June 30, 2021 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 2020 Annual Report and the Company’s other filings with the SEC.

Nature of the Business and Background

The Company is a pharmaceutical development company that is focused on developing and ultimately commercializing innovative therapeutics for patients with certain cancers and certain

non-cancerous

proliferation disorders. The Company has explored and expects to continue to explore acquiring or licensing other innovative preclinical and clinical stage therapeutics addressing unmet needs and orphan indications beyond cancer.

The Company’s current primary focus is on the development of therapies initially for prostate and lung cancer in the U.S. market utilizing SUBA-Itraconazole, a patented, oral formulation of the drug itraconazole currently approved by the U.S. Food and Drug Administration (“FDA”) and marketed as an anti-fungal, which the Company holds an exclusive U.S. license in the licensed field from the Company’s majority stockholder, Mayne Pharma Ventures Pty Ltd. (“Mayne Pharma”). SUBA-Itraconazole is currently licensed to the Company by Mayne Pharma on an exclusive basis in the United States in the field of certain cancers (prostate and lung cancer) and certain

non-cancerous

proliferation disorders pursuant to the Third Amended and Restated Supply and License Agreement (“Third Amended SLA”) between the Company and Mayne Pharma, dated December 17, 2018. Previously, the Company conducted a Phase 2b trial studying the use of SUBA-Itraconazole targeting basal cell carcinoma in patients with Basal Cell Carcinoma Nevus Syndrome (“SUBA-Itraconazole BCCNS”). Mayne Pharma assumed control of the clinical and regulatory program for SUBA-Itraconazole BCCNS in December 2018 pursuant to the Third Amended SLA in exchange for (among other consideration) a 9% quarterly cash royalty on future net sales, if any, of SUBA-Itraconazole

BCCNS in the United States.

The Company demonstrated

 in its previous Phase

2

b trial for SUBA-Itraconazole BCCNS that the dosing of oral capsules of SUBA-Itraconazole affects the Hedgehog signaling pathway, a major regulator of many fundamental cellular processes, which, in turn, can impact the development and growth of cancers such as basal cell carcinoma. Itraconazole has been approved by the FDA for, and has been extensively used to, treat fungal infections and has an extensive history of safe and effective use in humans. The Company has developed, optioned and licensed intellectual property and

know-how

related to the treatment of cancer patients using itraconazole and certain itraconazole analogues.

Manufacturing and Product Supply and Relationship with Mayne Pharma

The Company does not have any production facilities or manufacturing personnel. The Third Amended SLA provides for the supply to the Company of specially formulated capsules of SUBA-Itraconazole, manufactured by Mayne Pharma under cGMP (current good manufacturing practice) standards, for use by the Company in its clinical trials and for the future commercial supply following FDA approvals, if obtained. Pursuant to the Third Amended SLA, Mayne Pharma is obligated to supply the Company with its patented formulation of SUBA-Itraconazole in a particular oral dose formulation for the treatment of human patients with certain cancers and

non-cancerous

proliferation disorders for as long as the Third Amended SLA is in effect. The Company is required to perform specified development activities and to commercialize SUBA-Itraconazole for the treatment of cancer in the United States.

2.	Liquidity and management’s plans:

The Company had cash and cash equivalents of approximately $0.1 

million as of June 30, 2021. Based on the Company’s current operational plan and budget, including a deferral of cash compensation to Company employees and directors (see Note 8 – Subsequent Events), the Company expects that it has sufficient cash to manage its business into the first quarter of 2022, although this estimation assumes the Company does not begin any clinical trials, acquire other drug development opportunities or otherwise face unexpected events, costs or contingencies, any of which could affect the Company’s cash requirements. Available resources may be consumed more rapidly than anticipated, resulting in the need for additional funding. The Company intends to finance additional research and development, commercialization and distribution efforts and its working capital needs primarily through:

 

•

proceeds from public and private financings (including most recently, funds from the Company’s majority shareholder, Mayne Pharma) and, potentially, from other strategic transactions;

 

•

royalty revenue from Mayne Pharma from sales of SUBA-Itraconazole BCCNS upon and assuming approval by FDA (after earned royalties have been applied to any royalties advanced under Third Amended SLA ) , although it is uncertain if and when such FDA approval will be obtained;

 

•

proceeds from the exercise of outstanding warrants previously issued in private financings (including, potentially, warrants held by the Company’s majority shareholder, Mayne Pharma);

 

•

potential partnerships with other pharmaceutical companies to assist in the supply, manufacturing and distribution of products for which the Company would expect to receive upfront milestone and royalty payments;

 

•

potential licensing and joint venture arrangements with third parties, including other pharmaceutical companies where we would receive funding based on out-licensing our product; and

 

•

government or private foundation grants or loans which would be awarded to the Company to further develop the Company’s current and future therapies, or government payroll protection or similar programs available as a result of the novel coronavirus outbreak.

However, there is a significant risk that none of these plans will be implemented in a manner necessary to sustain the Company beyond the first quarter of 2022 and that the Company will be unable to obtain additional financing when needed on commercially reasonable terms, if at all. In particular, the Company is presently subject to shareholder litigation (see Note 7 – Legal Proceedings). The existence of the Action and the Putative Class Action (as defined in Note 7) and the uncertainty surrounding their outcome has impeded the Company’s ability to secure additional funding and may continue to do so for so long as the outcome of the Action and the Putative Class Action is uncertain.

In addition, on January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (“WHO”) declared the novel coronavirus

(“COVID-19”)

outbreak a public health emergency of international concern and on March 12, 2020 the WHO announced the outbreak was a pandemic. On January 31, 2020, the U.S. Health and Human Services Secretary declared

COVID-19

a public health emergency, and subsequently state and local governments have imposed various restrictions on public activity. The Company has maintained operations virtually during the outbreak. Although

COVID-19

vaccines have been introduced in 2021 and federal, state and local restrictions have been modified, variants of

COVID-19

have appeared, and thus the impact of

COVID-19

continues to be unknown and rapidly evolving. The continuation of

COVID-19

as a public health emergency could impact the Company’s ability to conduct operations (such as clinical trials) should adequate funding be obtained.

As a result of the foregoing circumstances, there is substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements included herein do not include any adjustments relating to the recoverability or classification of asset carrying amounts or the amounts and classification of liabilities that may result should the Company be unable to continue as a going concern.

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.

---

The Facility is available to the Company as follows: (i) $81,000 may be drawn upon request at any time in the first annual quarter of the Facility starting December 14, 2020 ($55,000 was requested and was outstanding at December 31, 2020. An additional $26,000 was drawn in January 2021) and (ii) so long as there is no event of default and Mayne Pharma does not give notice in its discretion 30 days before the start of a quarter that it is discontinuing the funding, $75,000 may be drawn in the second and third annual quarters of the Facility, respectively. In both March 2021 and June 2021, $75,000 was drawn bringing the total outstanding balance to $231,000 at June 30, 2021. No additional funding is available under the Mayne Term Debt Facility. The Company shall have one twelve month repayment free advance period from its first drawdown on the Facility. Each other advance on the Facility will be amortized over twelve equal monthly payments of principal plus interest. No premium is payable in the event that the Company pays all principal, interest and other outstanding amounts due to Mayne Pharma prior to the Maturity Date.

The Facility is unsecured, contains no financial covenants, requires no guarantees and is not accompanied by any equity component. The Loan Agreement includes certain limited representations and warranties and negative covenants of the Company.

An event of default under the Loan Agreement includes, among other things, (i) the Company breaches its obligations under the Loan Agreement, and where that breach is capable of remedy it does not remedy the breach within 20 business days after receipt of a notice from the Mayne Pharma of the breach, (ii) Mayne Pharma validly terminates the Third Amended and Restated Supply and License Agreement dated December 17, 2018 between the Company and Mayne Pharma, or (iii) the Company becomes insolvent, including by becoming the subject of the filing or institution of bankruptcy, liquidation or dissolution proceedings.

The Loan Agreement was negotiated and approved on behalf of the Company by a special committee of disinterested, independent members of the Company’s Board of Directors (the “Board”) which was formed on November 17, 2020 for such purpose. The special Board committee consisted of W. Mark Watson, R. Dana Ono and Debra Peattie, who are each disinterested with respect to Mayne Pharma.

6.	Stockholders’ Equity:

Employee Stock Plans

On March 20, 2020, members of the Company’s Board of Directors were awarded 4.5 million stock options pursuant to the 2014 Equity Incentive Plan (the “EIP”) with an exercise price of $0.05 and a Black-Scholes value of $0.038 that vested on the first anniversary of the grant date. The grant date fair value of common stock options was determined using the Black-Scholes model on the date of issuance and the number of shares expected to vest. The total Black-Scholes value of the March 20, 2020 stock options grants was approximately $0.2 million.

On September 17, 2020, officers of the Company were awarded 200,000 stock options pursuant to the EIP with an exercise price of $0.054 and a Black-Scholes value of $0.036 that vested on the grant date. The grant date fair value of common stock options was determined using the Black-Scholes model on the date of issuance and the number of shares expected to vest. The total Black-Scholes value of the September 17, 2020 stock options grants was approximately $7,200.

On December 21, 2020, officers of the Company and members of the Company’s Board of Directors were awarded 3,646,776 stock options pursuant to the EIP with an exercise price of $0.031 and a Black-Scholes value of $0.021 that vested on the grant date. The grant date fair value of common stock options was determined using the Black-Scholes model on the date of issuance and the number of shares expected to vest. The total Black-Scholes value of the December 21, 2020 stock options grants was approximately $77,000.

Total stock-based compensation for the six months ended June 30, 2021 was approximately $0.04 million and is related to common stock options issued pursuant to the EIP in 2020 as mentioned above. The expense is classified as general and administrative expense in the accompanying condensed statements of operations. As of June 30, 2021, there were 13,349,461 outstanding common stock options under the EIP of which 100% were vested. There was no unamortized stock-based compensation at June 30, 2021.

7.	Legal Proceedings:

The Company may from time to time become a party to various legal proceedings arising in the ordinary course of business. Except as discussed below, the Company is not the subject of any pending legal proceedings.

On July 9, 2019, Hedgepath, LLC (“HPLLC”), a significant minority stockholder of the Company and an investment vehicle associated with the Company’s former Executive Chairman, filed a civil action captioned

Hedgepath, LLC v. Magrab, et al.

, C.A.

No. 2019-0529-JTL,

in the Delaware Court of Chancery (the “Action”) against the Company’s directors

 

(except for Debra Peattie, who was not a director at the time)

and President and Chief Executive Officer, and a former director (collectively the “Individual Defendants”). On September 27, 2019, the Individual Defendants and Mayne Pharma each filed a motion to dismiss the Action.

On December 3, 2019, HPLLC filed the Verified Amended and Supplemental Complaint. In the Complaint in the Action, purportedly brought directly and derivatively on behalf of the Company, HPLLC alleges claims for breach of fiduciary duty, waste, declaratory judgment, statutory violations, and dilution of stockholder equity, against the Individual Defendants and Mayne Pharma in connection with (i) the previously announced issuance of certain of the Company’s equity securities to Mayne Pharma on or about January 8, 2018, (ii) Mayne Pharma’s alleged influence over the timing and conduct of the previous clinical trial of SUBA-Itraconazole for the treatment of BCCNS, and (iii) previously announced amendments to the Supply and License Agreement, as amended (presently memorialized at the Third Amended SLA), between the Company and Mayne Pharma and certain transactions contemplated thereby. The Complaint also alleges claims for breach of fiduciary duty and fraudulent misrepresentation in connection with allegedly false and misleading statements included in the Company’s press releases and filings with the SEC. The Complaint seeks unspecified damages from the defendants, and equitable and other relief. Legal costs associated directly with the Company as a nominal defendant were initially payable by the Company until certain retention amounts were reached. Such costs are currently covered by the Company’s insurance policy.

On January 10, 2020, the Individual Defendants and Mayne Pharma each filed a motion to dismiss the Complaint. A hearing on those motions was scheduled on March 26, 2020, but was postponed to June 2020 due to the ongoing coronavirus outbreak. On June 4, 2020, the Delaware Court of Chancery held a hearing at which the separate motions of the Individual Defendants and Mayne Pharma to dismiss the Complaint were presented. At the conclusion of the hearing, the Court issued an oral ruling in which it denied the motions to dismiss the Complaint. Accordingly, the Action is anticipated to proceed in the course typical for such litigation

, which could include alternative dispute resolution methods.

The Company believes the Action is

legally

and factually baseless, and the Individual Defendants intend to defend themselves vigorously.

 

7.	Legal Proceedings (continued):

Additionally, on March 23, 2020, a Stockholder Class Action Complaint was filed in the Delaware Court of Chancery by a stockholder and purported class representative, Samuel P. Sears, commencing litigation captioned

Sears v. Magrab et al

., C.A. No.

2020-0215-JTL

(the “Putative Class Action”). The plaintiff amended his complaint in May 2020. The defendants named in the Putative Class Action are identical to those named in the Action, with the exception that Inhibitor Therapeutics, Inc. is not a party to the litigation. The Putative Class Action asserts three direct breach of fiduciary duty claims (one against Mayne only, another against the Individual Defendants, and a third against all defendants) and the facts underlying those claims almost entirely mirror those alleged in the Action. On December 10, 2020, the Court of Chancery entered an order coordinating the Action and the Putative Class Action for purposes of the litigations.

The Company believes the Putative Class Action is legally and factually baseless, and the Individual Defendants intend to defend themselves vigorously.

8.	Subsequent events

Dividend payment

On July 15, 2021, the Company paid the June 30, 2021 dividends payable balance of $99,178 to Mayne Pharma by issuing 981,962 shares on the Company’s common stock, resulting in Mayne Pharma’s ownership of common stock increasing to 54.4% and Mayne Pharma’s fully-diluted ownership increasing to 54.9

%.

Compensation deferral

In an effort to preserve the

 Company’s cash resources, beginning

on July 1, 2021,

the

 

cash compensation

 

of the Company’s two employees and each member of the Board

will be deferred. The deferred amounts will be paid at an undetermined date in the future if the Company’s cash position improves. Prior to the deferral, four Board members received $2,000 per quarter each in cash compensation. The Chief Executive Officer and the Chief Financial Officer received $1,600 and $2,400 in cash compensation

 

monthly

, respectively, including all taxes and benefits.

We recognized less than $0.01 million in research and development expenses during the three months ended June 30, 2021 compared to approximately $0.1 million for the three months ended June 30, 2020. Research and development expenses for the three months ended June 30, 2020 primarily included salary expenses and expenses related to with the FDA on the Investigational New Drug application for use of SUBA-Itraconazole for prostate cancer that was cleared by the FDA in late 2019. The expenses for the three months ended June 30, 2021 primarily included patent expenses.

We recognized approximately $0.1 million in general and administrative expenses during the three months ended June 30, 2021 compared to $0.3 million for the three months ended June 30, 2020. General and administrative expenses consisted primarily of professional fees, compensation and related costs for corporate administrative staff and accrued compensation for Board members. The decrease is primarily due to the reduction of salaries and Board compensation in the three months ended June 30, 2021 compared to the three months ended June 30, 2020.

We recognized less than $0.01 million in research and development expenses during the six months ended June 30, 2021 compared to approximately $0.2 million for the six months ended June 30, 2020. The decrease is primarily due to the reduction of salaries in the six months ended June 30, 2021 compared to the six months ended June 30, 2020.

We recognized approximately $0.2 million in general and administrative expenses during the six months ended June 30, 2021 compared to $0.6 million for the six months ended June 30, 2020. General and administrative expenses consisted primarily of professional fees, compensation and related costs for corporate administrative staff and Board members including stock compensation expense. The decrease is primarily due to the reduction of salaries and Board compensation in the six months ended June 30, 2021 compared to the six months ended June 30, 2020.

We recognized $41,600 in gain on loan forgiveness during the six months ended June 30, 2021 when our PPP Loan was forgiven on March 31, 2021. There was no such gain in the six months ended June 30, 2020.

In addition, on January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO) declared the novel coronavirus (known as outbreak a public health emergency of international concern and on March 12, 2020 the WHO announced the outbreak was a pandemic. On January 31, 2020 the U.S. Health and Human Services Secretary declared a public health emergency, and subsequently state and local governments have imposed various restrictions on public activity. We have maintained operations virtually during the outbreak Although vaccines have been introduced in 2021 and federal, state and local restrictions have been modified, variants of have appeared, and thus the impact of continues to be unknown and rapidly evolving. The continuation of as a public health emergency could impact our ability to conduct operations (such as clinical trials) should adequate funding be obtained,

Certain information set forth in this Quarterly Report on Form 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) the application and availability of corporate funds and our need for future funds, or (iii) the timing for beginning, completion, and results of, clinical trials and the FDA’s review and/or approval and potential commercial launch of our products and product candidates and regulatory filings related to the same, or (iv) the results of pending litigation involving our company, may differ significantly from those set forth in the forward-looking statements. Such forward-looking statements also involve other factors 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 vary significantly from reporting period to reporting period. Such factors include, among others,

On July 9, 2019, Hedgepath, LLC (“HPLLC”), a significant minority stockholder of ours and an investment vehicle associated with our former Executive Chairman, filed a civil action captioned , C.A. in the Delaware Court of Chancery (the “Action”) against our directors (except for Debra Peattie, who was not a director at the time) and President and Chief Executive Officer, and a former director (collectively the “Individual Defendants”). On September 27, 2019, the Individual Defendants and Mayne Pharma each filed a motion to dismiss the Action.

Additionally, on March 23, 2020, a Stockholder Class Action Complaint was filed in the Delaware Court of Chancery by a stockholder and purported class representative, Samuel P. Sears, commencing litigation captioned ., C.A. No. (the “Putative Class Action”). The plaintiff amended his complaint in May 2020. The defendants named in the Putative Class Action are identical to those named in the Action, with the exception that Inhibitor Therapeutics, Inc. is not a party to the litigation. The Putative Class Action asserts three direct breach of fiduciary duty against Mayne only, another against the Individual Defendants, and a third against all the facts underlying those claims almost entirely mirror those alleged in the Action. On December 10, 2020, the Court of Chancery entered an order coordinating the Action and the Putative Class Action for purposes of the litigations.

On August 1, 2018, we entered into an Option Agreement with the University of Connecticut (“UConn”) regarding UConn’s itraconazole analogue technology that, if demonstrated to be safe and effective in preclinical studies, could be licensed to us in the future for therapeutic, prophylactic and diagnostic uses for cancerous and proliferation disorders in humans. UConn personnel were responsible for manufacturing the analogues, which we subsequently tested on a preliminary basis in animal models in skin cancer. While this testing failed to meet safety and efficacy objectives, the original option was extended in July 2019 on expanded terms to encompass additional itraconazole analogue intellectual property, and subsequently extended in January 2021 due to staffing and manufacturing challenges at UConn arising from as well as the impact of on our ability to carry out formulation studies or further anti-cancer testing in animals. The Option Agreement was allowed to expire on July 31, 2021 pursuant to its terms. However, we have had discussions with representatives of UConn on this matter and may potentially revisit a new option in the future if time and resources permit.