Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 26, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Inhibitor Therapeutics, Inc. | ||
Entity Central Index Key | 0001042418 | ||
Current Fiscal Year End Date | --12-31 | ||
No Trading Symbol Flag | true | ||
Entity Current Reporting Status | Yes | ||
Entity Shell Company | false | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Address, State or Province | FL | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Common Stock, Shares Outstanding | 375,876,361 | ||
Entity Public Float | $ 7,400,396 | ||
Title of 12(g) Security | Common stock | ||
ICFR Auditor Attestation Flag | true |
BALANCE SHEETS
BALANCE SHEETS - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 75,059 | $ 803,816 |
Prepaid expenses | 32,292 | 42,450 |
Total current assets | 107,351 | 846,266 |
Other long-term assets | 24,408 | 53,700 |
Total assets | 131,759 | 899,966 |
Current liabilities: | ||
Accounts payable | 269,416 | 315,940 |
Dividends payable, related party | 100,822 | 100,822 |
Note payable, short-term | 30,044 | |
Other liabilities | 25,124 | 14,339 |
Total current liabilities | 425,406 | 431,101 |
Note payable, long-term | 11,556 | |
Term debt facility, related party | 55,000 | |
Deferred revenue, related party | 3,000,000 | 3,000,000 |
Total liabilities | 3,491,962 | 3,431,101 |
Commitments and contingencies (Note 7) | ||
Stockholders' deficit: | ||
Preferred stock | 0 | 0 |
Common stock, $0.0001 par value; 500,000,000 shares authorized; 373,635,873 and 370,446,185 shares issued and outstanding at December 31, 2020 and 2019, respectively | 37,364 | 37,045 |
Additional paid-in capital | 49,814,043 | 49,384,953 |
Accumulated deficit | (57,172,476) | (55,913,999) |
Total stockholders' deficit | (3,360,203) | (2,531,135) |
Total liabilities and stockholders' (deficit) equity | 131,759 | 899,966 |
Series A Preferred Stock [Member] | ||
Stockholders' deficit: | ||
Preferred stock | 0 | 0 |
Series B Convertible, Redeemable, Preferred Stock [Member] | ||
Stockholders' deficit: | ||
Preferred stock | $ 3,960,866 | $ 3,960,866 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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 |
Common Stock, par value | $ 0.0001 | $ 0.0001 |
Common Stock, shares authorized | 500,000,000 | 500,000,000 |
Common Stock, shares issued | 373,635,873 | 370,446,185 |
Common Stock, shares outstanding | 373,635,873 | 370,446,185 |
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, Redeemable, 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 | 5,797,102 | 5,797,102 |
Preferred stock, shares outstanding | 5,797,102 | 5,797,102 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues [Abstract] | ||
Revenues | $ 0 | $ 0 |
Expenses: | ||
Research and development | 185,294 | 1,208,075 |
General and administrative | 873,703 | 1,539,821 |
Total expenses | 1,058,997 | 2,747,896 |
Loss from operations | (1,058,997) | (2,747,896) |
Interest income | 1,068 | 14,540 |
Net loss | (1,057,929) | (2,733,356) |
Preferred stock dividend | (200,548) | (200,000) |
Net loss applicable to common shareholders | $ (1,258,477) | $ (2,933,356) |
Basic and diluted loss per share | $ 0 | $ (0.01) |
Weighted average common shares outstanding | 371,927,734 | 370,432,295 |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Total | Series B Preferred Stock [Member] | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2018 | $ 32,351 | $ 3,960,866 | $ 37,008 | $ 49,015,120 | $ (52,980,643) |
Beginning balance, shares at Dec. 31, 2018 | 5,797,102 | 370,084,064 | |||
Issuance of common stock for payment of dividends on Preferred Stock, related party | 99,946 | $ 37 | 99,909 | ||
Issuance of common stock for payment of dividends on Preferred Stock, related party, shares | 362,121 | ||||
Stock based compensation | 269,924 | 269,924 | |||
Preferred stock dividends, related party | (200,000) | (200,000) | |||
Net loss | (2,733,356) | (2,733,356) | |||
Ending balance at Dec. 31, 2019 | (2,531,135) | $ 3,960,866 | $ 37,045 | 49,384,953 | (55,913,999) |
Ending balance, shares at Dec. 31, 2019 | 5,797,102 | 370,446,185 | |||
Issuance of common stock for payment of dividends on Preferred Stock, related party | 200,548 | $ 319 | 200,229 | ||
Issuance of common stock for payment of dividends on Preferred Stock, related party, shares | 3,189,688 | ||||
Stock based compensation | 228,861 | 228,861 | |||
Preferred stock dividends, related party | (200,548) | (200,548) | |||
Net loss | (1,057,929) | (1,057,929) | |||
Ending balance at Dec. 31, 2020 | $ (3,360,203) | $ 3,960,866 | $ 37,364 | $ 49,814,043 | $ (57,172,476) |
Ending balance, shares at Dec. 31, 2020 | 5,797,102 | 373,635,873 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities: | ||
Net loss | $ (1,057,929) | $ (2,733,356) |
Adjustments to reconcile net loss to net cash flows used in operating activities: | ||
Stock-based compensation | 228,861 | 269,924 |
Changes in assets and liabilities: | ||
Prepaid expenses and other assets | 39,450 | 28,138 |
Accounts payable and other current liabilities | (35,739) | (270,425) |
Net cash used in operating activities | (825,357) | (2,705,719) |
Financing activities: | ||
Advances of royalties, related party | 0 | 2,500,000 |
Payment of Preferred Stock cash dividend, related party | 0 | (99,178) |
Proceeds from notes payable | 41,600 | 0 |
Proceeds from term debt facility, related party | 55,000 | 0 |
Net cash provided by financing activities | 96,600 | 2,400,822 |
Net (decrease) increase in cash and cash equivalents | (728,757) | (304,897) |
Cash and cash equivalents at beginning of year | 803,816 | 1,108,713 |
Cash and cash equivalents at end of year | 75,059 | 803,816 |
Supplemental disclosure of non-cash financing activities: | ||
Issuance of common stock for payment of Preferred Stock dividend | 200,548 | 99,946 |
Accrued, but unpaid dividends | $ 100,822 | $ 100,822 |
Corporate overview
Corporate overview | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Corporate overview | 1. Corporate overview: Overview The accompanying audited financial statements of Inhibitor Therapeutics, Inc., a Delaware corporation (the “Company”, “INTI”, “we”, “us” or similar terminology) as successor to Commonwealth Biotechnologies, Inc., a Virginia corporation (“CBI”), have been prepared by the Company as a going concern, and in accordance with accounting principles generally accepted in the United States of America (“GAAP”). As used herein, the term “common stock” means the Company’s common stock, $0.0001 par value per share. Nature of the Business 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 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 The Company demonstrated in its previous Phase 2b 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 Overview of December 2018 Transactions with Mayne Pharma On December 17, 2018 (the “Effective Date”), the Company entered into the following related agreements (collectively, the “Transaction Documents”): • An agreement, by and among the Company, and Mayne Pharma, and Mayne Pharma International, an affiliate of Mayne Pharma (the “Agreement”); • The Third Amended and Restated Supply and License Agreement with Mayne Pharma (the “Third Amended SLA”), which amended and restated the Company’s Second Amended and Restated Supply and License Agreement with Mayne Pharma, dated as of May 15, 2015 (as amended immediately prior to the Effective Date, the “Second Amended SLA”); and • Amended and Restated Sublicense Agreement, by and between the Company and Mayne Pharma International, which amends and restates that certain Sublicense Agreement, dated August 31, 2015, between the Company and Mayne Pharma International, as amended. In addition, pursuant to the terms of the Agreement, the Company and Mayne Pharma agreed to vote in favor of the adoption of an Amended and Restated Certificate of Designation (“the Amended and Restated COD”) for the Company’s Series B Convertible Preferred Stock (the “Series B Preferred Stock”), which amended and restated the terms of the Series B Preferred Stock (originally issued to Mayne Pharma on January 8, 2018) to remove the redemption rights of the Series B Preferred Stock as described below. As of the Effective Date and at December 31, 2020, all 5,797,102 outstanding shares the Series B Preferred Stock are held by Mayne Pharma. The Transaction Documents resulted from negotiations regarding the existing right of Mayne Pharma under the Second Amended SLA to elect to assume control of the regulatory and clinical development program for SUBA-Itraconazole for the treatment of BCCNS in exchange for a royalty on any future net sales of SUBA-Itraconazole BCCNS by Mayne Pharma in the United States if and FDA New Drug Application (“NDA”) was not accepted for filing by FDA by December 31, 2018 (subject to limited extension if the NDA were filed in December 2018). Based on unforeseen requirements imposed by FDA in September 2018, the Company determined that it would be unable to responsibly file the SUBA-Itraconazole BCCNS NDA by this deadline, and thus the Company commenced negotiations with Mayne Pharma to transfer SUBA-Itraconazole BCCNS in advance of December 31, 2018 on negotiated terms deemed beneficial to the Company. The Transaction Documents were 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 October 26, 2018 for such purpose. The special Board committee consisted of three members of the Board who were each disinterested with respect to Mayne Pharma. December 2018 Agreement with Mayne Pharma Pursuant to the terms of the Agreement, on the Effective Date, Mayne Pharma (in its capacity as the holder of more than 50% of the outstanding voting securities of the Company) executed and delivered to the Company a stockholder consent which consented to the taking of the following actions: (a) the adoption of the Amended and Restated COD; (b) the election of each E. Brendan Magrab, W. Mark Watson, Dr. R. Dana Ono, Stefan J. Cross and Robert D. Martin (each a current member of the Board) to serve on the Board for a one-year In addition, pursuant to the Agreement, for the period beginning on the Effective Date and ending three (3) years from the Effective Date, in the event that the Company asks its stockholders (whether at a meeting of stockholders or pursuant to a written consent of stockholders) to vote on or approve a proposal to effect a reverse split of the Company capital stock for the purpose of uplisting the common stock to a U.S. national securities exchange (a “Reverse Stock Split Proposal”), Mayne Pharma (on behalf of itself and its affiliates) agreed to vote or cause to be voted (in person, by proxy or by action by written consent, as applicable) all shares of the Company’s voting capital stock that either Mayne Pharma then owns or over which Mayne Pharma has voting control in favor of the adoption and approval of any such Reverse Stock Split Proposal. No assurances are given that the Company will seek an uplisting to a U.S. national securities exchange or implement a reverse stock split of its common stock. Also, pursuant to the Agreement, Mayne Pharma consented and agreed (under the terms of agreements previously executed with the Company) to an increase in the number of shares of common stock that the Company may issue under the EIP to 17,624,000 shares from the current limit of 6,624,000 shares, with the agreement and understanding that such increase will be utilized by the Company during the period from the Effective Date through December 31, 2021. December 2018 - Third Amended and Restated Supply and License Agreement with Mayne Pharma Pursuant to the Third Amended SLA, as of the Effective Date, Mayne Pharma assumed control of the regulatory and clinical development program for SUBA-Itraconazole BCCNS and immediately assumed responsibility for all expenses related to exploiting the SUBA-Itraconazole product in the BCCNS field, provided that the Company continues to be responsible for all liabilities related to the product in the United States prior to the Effective Date. The Third Amended SLA will continue in effect on an exclusive basis in the United States on substantially the same terms as were provided for under the Second Amended SLA, except as described below. In consideration of the transfer to Mayne Pharma of the SUBA-Itraconazole BCCNS clinical data and regulatory rights, the Company will receive the following consideration: (a) a 9% quarterly cash royalty (the “Royalty”) on future net sales, if any, of SUBA-Itraconazole product in the BCCNS field in the United States, from which certain royalties owed by the Company to Mayne Pharma for access to certain patents would also be funded. (b) Mayne Pharma’s agreement to advance funds to the Company in an aggregate amount of up to $5 million on the following terms and conditions: (i) As of the Effective Date, Mayne Pharma shall make an Advance to the Company of $500,000; the Company received this first Advance on December 18, 2018; (ii) Within three (3) business days following the completion of the agreed upon activities associated with transferring the SUBA-Itraconazole BCCNS product to Mayne Pharma, Mayne Pharma must make an Advance to the Company of $1 million; the Company received this Advance in January 2019; (iii) If, and only if, the Company’s Phase 2(b) clinical trial data have been provided to Mayne Pharma in all material respects so as to allow Mayne Pharma to assume control of SUBA-Itraconazole BCCNS in the United States, upon the earlier of June 30, 2019 or the acceptance for filing by FDA of an NDA for the SUBA-Itraconazole BCCNS, Mayne Pharma must make an Advance to the Company of $1,500,000; the Company received this advance in July 2019; and (iv) If the Company raises aggregate gross proceeds of more than $3 million from the sale of new common stock, preferred stock equity subordinate to the Series B Preferred Stock held by Mayne Pharma or warrants to third parties (“New Securities”) in one or more equity financings by June 30, 2021 (the “Equity Funding Achievement”), the Company may request additional Advances of up to an amount equal to $2 million less the amount of aggregate gross proceeds received by the Company from Mayne Pharma from the sale of New Securities if Mayne Pharma elects to participate in such equity financings pursuant to contractual pro rata participation rights contained in the Third Amended SLA. (c) The field covered by the Third Amended SLA was amended to specifically include only the following indications: (i) any prostate cancer, prostatic intraepithelial neoplasia and benign prostatic hyperplasia, (ii) any lung cancer and atypical adenomatous hyperplasia, and (iii) familial adenomatous polyposis, colorectal polyps and Barett’s esophagus (the “Field”). The Company’s work on these indications will no longer be tied to the achievement of clinical or commercial target dates as they were under the Second Amended SLA. (d) Mayne Pharma will continue to provide quantities of SUBA-Itraconazole drug and placebo oral capsules without charge for the Company’s SUBA-Itraconazole Prostate clinical studies and for future indications as agreed to by the parties. (e) Pursuant to the Third Amended SLA, Mayne Pharma has licensed to the Company the right to use all pre-clinical With respect to each Advance made by Mayne Pharma prior to the receipt of FDA approval of an NDA for SUBA-Itraconazole BCCNS, each $0.75 increment of each such Advance will be credited and set off against each $1.00 increment of Royalty owed to the Company, and with respect to each Advance made by Mayne Pharma following the receipt of FDA approval of an NDA for SUBA-Itraconazole BCCNS, each $0.85 increment of each such Advance will be credited and set off against each $1.00 increment of Royalty owed to the Company. In addition, if, prior to June 30, 2021, the Company has not fulfilled the Equity Funding Achievement, Mayne Pharma shall have the right to satisfy all of its remaining Royalty obligations by making a single lump sum payment to the Company in an amount equal to seventy percent (70%) of the fair market value of the remaining royalties payable to the Company as determined by an independent appraisal process. The Third Amended SLA also gives Mayne Pharma the right to convert the Company’s rights licensed from Mayne Pharma under the Third Amended SLA to a non-exclusive December 2018 Amended and Restated Sublicense Agreement The Amended and Restated Sublicense Agreement amended and replaced a similar agreement entered into between the Company and Mayne Pharma International, dated as of May 15, 2015, under which Mayne Pharma International sublicensed to the Company the exclusive U.S. rights to two certain third-party patents relating to the use of itraconazole as a treatment for cancer and age-related On August 21, 2019, the Company received written notice of termination of the Amended and Restated Sublicense Agreement due to the fact that the third party from whom Mayne Pharma International was itself sublicensing the Patents had terminated such sublicense agreement. Thereafter, on August 27, 2019, the Company and Mayne Pharma International entered into a new Sublicense Agreement, effective August 20, 2019 (the “New Sublicense Agreement”), under which the Company received from Mayne Pharma International a sublicense to the Patents on nearly identical terms as the Amended and Restated Sublicense Agreement (including with respect to licensed field, the licensed indications and the license fees, milestone payments and minimum annual and running royalties that may be owed by the Company to Mayne Pharma International, as well as the terms related to patent prosecution and infringement, reporting and indemnification). Mayne Pharma International was able to enter into the New Sublicense Agreement because, subsequent to the termination of the Amended and Restated Sublicense Agreement, Mayne Pharma International entered into a direct license agreement with respect to the Patents with The Johns Hopkins University, the owner of the Patents. The New Sublicense Agreement has a term commencing on August 20, 2019 and continuing until the earlier of: (a) the date of expiration of the last to expire Patent; or (b) notice by Mayne Pharma International with immediate effect promptly after termination or expiry of its rights to license the Patents. Mayne Pharma International and the Company have the right to terminate the New Sublicense Agreement upon the occurrence of certain events, including the bankruptcy of a party or breach of a party’s obligations under the New Sublicense Agreement (subject to a notice and cure period). Mayne Pharma International may also terminate the New Sublicense Agreement upon the expiration or termination of that certain Third Amended SLA. As of December 31, 2020, the New Sublicense Agreement remains in effect with Mayne Pharma International, but only with respect to U.S. Patent No. 8,653,083 entitled “ Hedgehog Pathway Antagonists to Treat Disease January 2018 Series B Preferred Stock Purchase Agreement On January 8, 2018, the Company entered into a Securities Purchase Agreement with Mayne Pharma (the “Securities Purchase Agreement”), pursuant to which Mayne Pharma agreed to purchase from the Company, and the Company agreed to issue to Mayne Pharma (over three closings as described further below): (i) up to 7,246,377 shares of the Company’s then newly designed Series B Preferred Stock at $0.69 per share of Series B Preferred Stock (with each share of Series B Preferred Stock being convertible into three (3) shares of the Company’s common stock for an effective price per share of common stock of $0.23), for potential gross proceeds of $5,000,000; (ii) Series A Warrants to purchase up to an aggregate 5,434,783 shares of common stock, with a two-year (iii) Series B Warrants to purchase up to an aggregate of 5,434,783 shares of common stock, with a five-year term from the date of issuance and an exercise price per share of $0.275 (together with the Series A Warrants, the “Warrants”). The transactions contemplated by the Purchase Agreement are referred to herein as the “Financing.” The Financing contemplated three closings (each, a “Closing”), as follows: (i) $2.4 million was funded at an initial closing of the Financing that occurred on January 10, 2018 (the “Initial Closing”); (ii) $1.6 million was funded in July 2018 (the “Second Closing”); and (iii) $1.0 million that was to be funded on or before December 31, 2018 (or the “Third Closing”) did not occur. The funding of the Third Closing was conditioned upon the acceptance of filing by the FDA of the Company’s NDA for SUBA-Itraconazole BCCNS, which did not occur. Terms of the Series B Preferred Stock The Series B Preferred Stock carries the following provisions: Price Per Share Dividends 6-month Voluntary and Mandatory Conversion Liquidation Preference Seniority Voting Terms of the Warrants The Warrants are divided equally between the Series A Warrants and the Series B Warrants (i.e., with each being exercisable for an aggregate of 5,434,783 shares of common stock if all Closings had occurred), which represents fifty percent (50%) warrant coverage on the shares of common stock underlying the Series B Preferred Stock. The Warrants were issued, pro rata in relation to the total investment in the Series B Preferred Stock, at each Closing. Since the Third Closing did not occur, only 4,347,827 were issued of each the Series A Warrants and the Series B Warrants. The Warrants are substantially identical in form, except that: (i) the exercise price per share of the Series A Warrants shall be $0.23 per share and the exercise price per share of the Series B Warrants shall be $0.275 per share (collectively, the “Warrant Exercise Price”) and (ii) The Series A Warrants shall have a term of two (2) years from the date of issuance and the Series B Warrants shall have term of five (5) years from the date of issuance. The Warrant Exercise Price shall be subject to customary stock-based, but not price-based, anti-dilution protection. The Warrants will not be eligible for “cashless” exercise. |
Liquidity and management's plan
Liquidity and management's plans | 12 Months Ended |
Dec. 31, 2020 | |
Text Block [Abstract] | |
Liquidity and management's plans | 2. Liquidity and management’s plans: At December 31, 2020, the Company had approximately $0.1 million in cash and cash equivalents. As such, the Company has very little cash and has been unable for some time to secure substantive additional funding to resume research and development activities, due in significant part to ongoing litigations against the Company (below and see note 7). Based on the Company’s current operational plan and budget, and taking in consideration Mayne Pharma Term Debt Facility (see note 5) and the late December 2020 reduction of payroll costs, the Company expects that it has sufficient cash to manage its business into the fourth quarter of 2021, although this estimation assumes the only minimal continuing operations and that the Company does not begin any clinical trials, acquire other drug development opportunities or otherwise face unexpected events, costs or contingencies (including, without limitation, as a result of the ongoing litigations), 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, financings from the Company’s majority shareholder, Mayne Pharma) and, potentially, from strategic transactions; • advances from Mayne Pharma of potential future royalties on the SUBA-Itraconazole BCCNS product available under the Third Amended SLA; • royalty revenue from Mayne Pharma from sales of SUBA-Itraconazole BCCNS upon approval by FDA (after earned royalties have been applied to any advances due under the Third Amended SLA) • proceeds from the exercise of outstanding warrants previously issued in private financings (including, potentially, warrants held by our majority shareholder, Mayne Pharma); • potential partnerships with other pharmaceutical companies to assist in the supply, manufacturing and distribution of our products for which we would expect to receive 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 • seeking government or private foundation grants which would be awarded to us to further develop our current and future anti-cancer therapies. However, there is a risk that none of these plans will be implemented in a manner necessary to sustain the Company for an extended period of time 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 6 – Legal Proceedings). The existence of the Action and the Class Action (as defined in note 6) 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 Class Action is uncertain. 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 and declined to dismiss all counts alleged in the Complaint. Accordingly, the Action is anticipated to proceed in the course typical for such litigation. This ruling creates additional uncertainties which could continue to hamper the Company’s ability to raise capital. In addition, on January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (“WHO”) declared the novel coronavirus 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. The Company has maintained operations virtually during the outbreak, but the impact of the outbreak currently is unknown and rapidly evolving. The related health crisis has adversely affected the U.S. and global economy, resulting in an economic downturn that has impacted the financial markets and the Company’s ability to raise capital. As a result of the foregoing circumstances, there is substantial doubt about the Company’s ability to continue as a going concern. The 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies: Recent accounting pronouncements Management has considered all other recent accounting pronouncements that are issued, but not effective, and it does not believe that they will have a significant impact on the Company’s results of operations or financial position. Estimates The preparation of 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 revenues. 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 by Mayne Pharma should be classified as non-current. Cash and Cash Equivalents The Company considers all highly liquid debt instruments purchased with an original maturity of three months or less to be cash equivalents. At times, the Company may maintain cash balances in excess of Federal Deposit Insurance Corporation insured amounts of $250,000 for substantially all accounts. As of December 31, 2020, the Company had no funds in excess of the amount covered by Federal Deposit Insurance Corporation with two financial institutions. Research and Development Expenses Research and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties who conduct research and development activities on behalf of the Company as well as purchased in-process Stock-Based Compensation The Company accounts for stock-based awards to employees and non-employees In applying the Black-Scholes option pricing model for options issued in February 2019 that vested on the one-year In applying the Black-Scholes option pricing model for options issued in March 2020 that vest on the first anniversary of the grant date, the assumptions were as follows: expected price volatility of 97.4%; risk-free interest rate of 0.52%; weighted average expected life in years of 5.5; and no dividend yield. The value of these awards is based upon their grant-date fair value. That cost is recognized over the period during which the employee is required to provide service in exchange for the award. In applying the Black-Scholes option pricing model for options issued in September 2020 that vested on the grant date, the assumptions were as follows: expected price volatility of 86.98%; risk-free interest rate of 0.28%; weighted average expected life in years of 5.0; and no dividend yield. The value of these awards is based upon their grant-date fair value. That cost was recognized as expense on the grant date. In applying the Black-Scholes option pricing model for options issued in December 2020 that vested on the grant date, the assumptions were as follows: expected price volatility of 87.5%; risk-free interest rate of 0.39%; weighted average expected life in years of 5; and no dividend yield. The value of these awards is based upon their grant-date fair value. That cost was recognized as expense on the grant date. 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. See Note 4 for details. 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 for the years ended December 31, 2020 or 2019. |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2020 | |
Notes Payable [Abstract] | |
Notes Payable | 4. Notes Payable On May 3, 2020, the Company received loan proceeds of $41,600 (the “PPP Loan”) from Citibank, N.A. pursuant to the Small Business Administration Paycheck Protection Program under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The PPP Loan, which was in the form of a promissory note dated May 2, 2020, matures on May 2, 2022 and bears interest at a rate of 1% per annum. No payments have been made under the loan, although interest will continue to accrue during the deferment period. The Company may prepay the PPP Loan at any time prior to maturity with no prepayment penalties. The promissory note contains events of default and other provisions customary for a loan of this type. Under the terms of the CARES Act, PPP Loan participants can apply for and be granted forgiveness for all or a portion of loans provided under the CARES Act. Under the terms of the CARES Act, PPP loans and accrued interest are forgivable after eight weeks as long as the borrower uses the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and maintains its payroll levels. The amount of loan forgiveness will be reduced if the borrower terminates employees or reduces salaries during the eight week period. The Company has used the loan proceeds for purposes consistent with the CARES Act, and anticipates that all of the loan amount will be forgiven, but there is no assurance provided that the Company will obtain forgiveness of the PPP Loan in whole or part. |
Mayne Term Debt Facility
Mayne Term Debt Facility | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Mayne Term Debt Facility | 5. Mayne Term Debt Facility On December 12, 2020, the Company and Mayne Pharma entered into a letter agreement for a term debt facility (the “Loan Agreement”) pursuant to which Mayne Pharma provided an aggregate $231,000 credit facility to the Company (the “Facility”). The Facility bears interest at the rate equal to the interest rate tied to the US Bank Prime Rate plus 5.00% (the “Interest Rate”) with a maturity date of twenty four (24) months from the date of the first drawdown (the “Maturity Date”). The Interest Rate shall be adjusted for each drawdown on the Facility in accordance with changes in the monthly average of the US Bank Prime Rate, as reported in the Federal Reserve Statistical Release H .15 for the month preceding the week in which the Company shall make a drawdown against the Facility. Proceeds drawn from the Facility will be used by the Company for general working capital and corporate purposes. The Facility shall be 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 is outstanding at December 31, 2020) 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. Any drawdown by the Company must equal or exceed $25,000. 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. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 6. Income Taxes: The difference between expected income tax benefits and income tax benefit recorded in the financial statements is explained below: December 31, 2020 2019 Income taxes benefit computed at statutory rate $ (222,165 ) $ (574,005 ) State income tax benefit, net (45,967 ) (112,934 ) Other (13,668 ) 40,085 Change in valuation allowance 281,800 646,854 Total $ — $ — The significant components of deferred income tax assets and liabilities consist of the following: December 31, Deferred tax assets (liabilities) 2020 2019 In-process $ 742,574 $ 736,325 Net operating loss carry forward 6,608,114 6,425,461 R&D credit 190,515 339,052 Share-based compensation 34,231 33,943 Other 6,060 2,742 7,581,494 7,537,523 Less: valuation allowance (7,581,494 ) (7,537,523 ) Total $ — $ — In accordance with GAAP, it is required that a deferred tax asset be reduced by a valuation allowance if, based on the weight of available evidence it is more likely than not (a likelihood of more than 50 percent) that some portion or all of the deferred tax assets will not be realized. At December 31, 2020 and 2019, the Company recorded a 100% valuation allowance against its deferred tax assets as it has determined such amounts will not be currently realizable. The Company has a federal net operating loss (“NOLs”) of approximately $26.1 million as of December 31, 2020. Under Section 382 and 383 of the Internal Revenue Code, if an ownership change occurs with respect to a “loss corporation”, as defined, there are annual limitations on the amount of the NOLs and other deductions which are available to the Company. The portion of the NOLs incurred prior to August 12, 2013 is subject to this limitation. As such, the use of these NOLs to offset taxable income is limited to approximately $35,000 per year and the Company has written off the deferred tax assets associated with the NOLs limited due to the ownership change that occurred on August 12, 2013. The Company’s State NOLS are approximately $26.1 million as of December 31, 2020. The loss carryforwards began |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | 7 Stockholders’ Equity: Employee Stock Plans A 2009 Stock Incentive Plan was adopted by the Board of Directors and approved by the shareholders of CBI, the Company’s predecessor company. There are no options outstanding under this plan. On July 18, 2014, the EIP was adopted by the Company’s Board of Directors. On September 30, 2014, the EIP was approved by the majority of stockholders. The 2014 EIP initially authorized the issuance of up to 32,583,475 shares of the Company’s common stock. An additional 11 million shares were added to the 2014 EIP for a total of 43,583,475 shares pursuant to the Agreement entered into by the Company and Mayne Pharma in December 2018. Stock option activity for the years ended December 31, 2020 and 2019 is as follows: Number of Weighted Average Aggregate Outstanding at January 1, 2019 3,424,000 $ 0.28 $ 0 Granted to Directors and Officers in 2019 3,195,527 $ 0.07 Exercised — — Forfeited (1,616,842 ) $ 0.15 Outstanding at December 31, 2019 5,002,685 $ 0.19 $ 1,260 Granted to Directors and Officers in 2020 8,346,776 $ 0.04 Exercised — — Forfeited — — Outstanding at December 31, 2020 13,349,461 $ 0.10 $ 14,587 Options outstanding at December 31, 2020 are as follows: Range of Exercise Prices Number Weighted Average Weighted Average Aggregate $ 0.03 - $ 0.10 10,555,461 9.28 $ 0.05 $ 14,587 $ 0.11 - $ 0.30 2,167,000 6.69 $ 0.26 $ — $ 0.31 - $ 0.33 627,000 7.46 $ 0.33 $ — 13,349,461 $ 14,587 Options exercisable at December 31, 2020 are as follows: Range of Exercise Prices Number Weighted Average Weighted Average Aggregate $ 0.03 - $0.10 6,055,461 9.32 $ 0.05 $ 14,587 $ 0.11 - $0.30 2,167,000 6.69 $ 0.26 $ — $ 0.31 - $0.33 627,000 7.46 $ 0.33 $ — 8,849,461 $ 14,587 The weighted average grant date fair value of options granted during the years ended December 31, 2020 and December 31, 2019 was $0.03 and $0.05, respectively. Non-vested Number of Weighted Average Aggregate Non-vested at January 1, 2020 2,208,685 Granted 4,500,000 Vested (2,208,685 ) Forfeited — 4,500,000 $ 0.05 $ 0 Incentive awards may be in the form of stock options, restricted stock, restricted stock units and performance and other awards. In the case of incentive stock options, the exercise price will not be less than 100% of the fair market value of shares covered at the time of the grant, or 110% for incentive stock options granted to persons who own more than 10% of the Company’s voting stock. Options granted will generally vest over a three-year period from the date of grant and will be exercisable for ten years, except that the term may not exceed five years for incentive stock options granted to persons who own more than 10% of the Company’s outstanding common stock. Stock-based compensation expense is determined based on the fair value of the stock-based awards and recognized over the vesting period. The Company recognized $228,861 and $269,924 in stock-based compensation expense related to stock options for the years ended December 31, 2020 and 2019, respectively. As of December 31, 2020, there was unamortized stock-based compensation of approximately $0.04 million. Preferred Stock Issuances See Note 1 for discussion of preferred stock issued to Mayne Pharma in 2018. Warrants There were 50,270,563 outstanding common stock warrants at December 31, 2020 with a weighted average exercise price of $0.13 and a weighted average remaining life of 0.5 years. All were exercisable at December 31, 2020 and December 31, 2019. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 8 Related party transactions: The Company has significant contractual agreements with majority stockholder Mayne Pharma as discussed in Note 1 and Note 5. There were no amounts due to or from Mayne Pharma at December 31, 2020 or December 31, 2019. |
Legal Proceedings
Legal Proceedings | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Proceedings | 9. 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. 2019-0529-JTL, 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 Company 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 Company press releases and filings with the SEC. The Complaint seeks unspecified damages from the defendant, 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 have been nominal through June 30, 2020 and are included in general and administrative expenses for the current period. 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 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. Accordingly, the Action is anticipated to proceed in the course typical for such litigation. The Company believes the Action is legally and factually baseless, and the Individual Defendants intend to defend themselves vigorously. Additionally, on March 23, 2020, a Stockholder Class Action Complaint was filed in the Delaware Court of Chancery by a Company stockholder and purported class representative Samuel P. Sears, commencing litigation captioned Sears v. Magrab et al., C.A. No. 2020-0215-JTL claims-one defendants-and The Company believes the Putative Class Action is legally and factually baseless, and the Individual Defendants intend to defend themselves vigorously. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Recent accounting pronouncements | Recent accounting pronouncements Management has considered all other recent accounting pronouncements that are issued, but not effective, and it does not believe that they will have a significant impact on the Company’s results of operations or financial position. |
Estimates | Estimates The preparation of 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 revenues. 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 by Mayne Pharma should be classified as non-current. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid debt instruments purchased with an original maturity of three months or less to be cash equivalents. At times, the Company may maintain cash balances in excess of Federal Deposit Insurance Corporation insured amounts of $250,000 for substantially all accounts. As of December 31, 2020, the Company had no funds in excess of the amount covered by Federal Deposit Insurance Corporation with two financial institutions. |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties who conduct research and development activities on behalf of the Company as well as purchased in-process |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based awards to employees and non-employees In applying the Black-Scholes option pricing model for options issued in February 2019 that vested on the one-year In applying the Black-Scholes option pricing model for options issued in March 2020 that vest on the first anniversary of the grant date, the assumptions were as follows: expected price volatility of 97.4%; risk-free interest rate of 0.52%; weighted average expected life in years of 5.5; and no dividend yield. The value of these awards is based upon their grant-date fair value. That cost is recognized over the period during which the employee is required to provide service in exchange for the award. In applying the Black-Scholes option pricing model for options issued in September 2020 that vested on the grant date, the assumptions were as follows: expected price volatility of 86.98%; risk-free interest rate of 0.28%; weighted average expected life in years of 5.0; and no dividend yield. The value of these awards is based upon their grant-date fair value. That cost was recognized as expense on the grant date. In applying the Black-Scholes option pricing model for options issued in December 2020 that vested on the grant date, the assumptions were as follows: expected price volatility of 87.5%; risk-free interest rate of 0.39%; weighted average expected life in years of 5; and no dividend yield. The value of these awards is based upon their grant-date fair value. That cost was recognized as expense on the grant date. |
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. See Note 4 for details. 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 for the years ended December 31, 2020 or 2019. |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Difference Between Expected Income Tax Benefits and Income Tax Benefit Recorded in the Financial Statements | The difference between expected income tax benefits and income tax benefit recorded in the financial statements is explained below: December 31, 2020 2019 Income taxes benefit computed at statutory rate $ (222,165 ) $ (574,005 ) State income tax benefit, net (45,967 ) (112,934 ) Other (13,668 ) 40,085 Change in valuation allowance 281,800 646,854 Total $ — $ — |
Components of Deferred Income Tax Assets and Liabilities | The significant components of deferred income tax assets and liabilities consist of the following: December 31, Deferred tax assets (liabilities) 2020 2019 In-process $ 742,574 $ 736,325 Net operating loss carry forward 6,608,114 6,425,461 R&D credit 190,515 339,052 Share-based compensation 34,231 33,943 Other 6,060 2,742 7,581,494 7,537,523 Less: valuation allowance (7,581,494 ) (7,537,523 ) Total $ — $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Federal Home Loan Banks [Abstract] | |
Schedule of Stock Option Activity | Stock option activity for the years ended December 31, 2020 and 2019 is as follows: Number of Weighted Average Aggragate Outstanding at January 1, 2019 3,424,000 $ 0.28 $ 0 Granted to Directors and Officers in 2019 3,195,527 $ 0.07 Exercised — — Forfeited (1,616,842 ) $ 0.15 Outstanding at December 31, 2019 5,002,685 $ 0.19 $ 1,260 Granted to Directors and Officers in 2020 8,346,776 $ 0.04 Exercised — — Forfeited — — Outstanding at December 31, 2020 13,349,461 $ 0.10 $ 14,587 |
Information Regarding Stock Options Outstanding and Exercisable | Options outstanding at December 31, 2020 are as follows: Range of Exercise Prices Number Weighted Average Weighted Average Aggregate $ 0.03 - $ 0.10 10,555,461 9.28 $ 0.05 $ 14,587 $ 0.11 - $ 0.30 2,167,000 6.69 $ 0.26 $ — $ 0.31 - $ 0.33 627,000 7.46 $ 0.33 $ — 13,349,461 $ 14,587 Options exercisable at December 31, 2020 are as follows: Range of Exercise Prices Number Weighted Average Weighted Average Aggregate $ 0.03 - $0.10 6,055,461 9.32 $ 0.05 $ 14,587 $ 0.11 - $0.30 2,167,000 6.69 $ 0.26 $ — $ 0.31 - $0.33 627,000 7.46 $ 0.33 $ — 8,849,461 $ 14,587 |
Summary of Non-vested Stock Option Activity | Non-vested Number of Weighted Average Aggragate Non-vested at January 1, 2020 2,208,685 Granted 4,500,000 Vested (2,208,685 ) Forfeited — 4,500,000 $ 0.05 $ 0 |
Corporate Overview - Additional
Corporate Overview - Additional Information (Detail) | Jul. 31, 2018USD ($) | Jan. 10, 2018USD ($) | Jan. 08, 2018USD ($)$ / sharesshares | Dec. 31, 2020USD ($)Conversion$ / sharesshares | Dec. 31, 2018USD ($) | Dec. 18, 2018USD ($) | Dec. 31, 2019$ / sharesshares |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | |||||
Preferred stock, shares outstanding | 0 | 0 | |||||
Royalty rate on future net sales | 9.00% | ||||||
Description of royalty payment | With respect to each Advance made by Mayne Pharma prior to the receipt of FDA approval of an NDA for SUBA-Itraconazole BCCNS, each $0.75 increment of each such Advance will be credited and set off against each $1.00 increment of Royalty owed to the Company, and with respect to each Advance made by Mayne Pharma following the receipt of FDA approval of an NDA for SUBA-Itraconazole BCCNS, each $0.85 increment of each such Advance will be credited and set off against each $1.00 increment of Royalty owed to the Company. | ||||||
Fair value inputs value royalty rate | 70.00% | ||||||
Series B Convertible Redeemable Preferred Stock [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Preferred stock, shares outstanding | 5,797,102 | ||||||
Series A Warrants [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Warrants issued to purchase common stock | 4,347,827 | ||||||
Series B Warrants [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Warrants issued to purchase common stock | 4,347,827 | ||||||
Securities Purchase Agreement [Member] | Series B Preferred Stock [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Shares issued, price per share | $ / shares | $ 0.69 | ||||||
Shares issued, price per share | Conversion | 3 | ||||||
Mayne Pharma [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Voting right percentage | 50.00% | ||||||
Consideration in advance funds of clinical data and regulatory rights | $ | $ 5,000,000 | $ 500,000 | |||||
Gross proceeds from sale of new common stock, preferred stock equity subordinate | $ | $ | $ 3,000,000 | ||||||
Mayne Pharma [Member] | Equity Incentive Plan [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Shares authorized to be issued | 6,624,000 | ||||||
Number of shares of common stock issued | 17,624,000 | ||||||
Mayne Pharma [Member] | Equity Incentive Plan [Member] | 2014 [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Increase in equity incentive plan | 11,000,000 | ||||||
Shares authorized to be issued | 32,583,475 | ||||||
Number of shares of common stock issued | 43,583,475 | ||||||
Mayne Pharma [Member] | Upon Fda Approval [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Consideration in advance funds of clinical data and regulatory rights | $ | $ 1,500,000 | ||||||
Mayne Pharma [Member] | SUBA Itraconazole BCCNS [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Consideration in advance funds of clinical data and regulatory rights | $ | 1,000,000 | ||||||
Mayne Pharma [Member] | HPPI [Member] | Available-for-sale Securities [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Consideration in advance funds of clinical data and regulatory rights | $ | $ 2,000,000 | ||||||
Mayne Pharma [Member] | Series B Convertible Redeemable Preferred Stock [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Preferred stock, shares outstanding | 5,797,102 | ||||||
Mayne Pharma [Member] | Securities Purchase Agreement [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Percentage of warrant coverage on shares of Common Stock | 50.00% | ||||||
Purchase Agreement, potential gross proceeds | $ | $ 5,000,000 | ||||||
Mayne Pharma [Member] | Securities Purchase Agreement [Member] | Series B Preferred Stock [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Preferred stock convertible to common stock | 17,391,306 | ||||||
Purchase Agreement, price per share of preferred stock to be issued | $ / shares | $ 0.69 | ||||||
Preferred stock dividend rate percentage | 5.00% | ||||||
Conversion price per share | $ / shares | $ 0.23 | ||||||
Purchase Agreement, preferred stock to be issued | 7,246,377 | ||||||
Mayne Pharma [Member] | Securities Purchase Agreement [Member] | Minimum [Member] | Series B Preferred Stock [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Purchase Agreement, redemption period | 5 years | ||||||
Mayne Pharma [Member] | Securities Purchase Agreement [Member] | Common Stock [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Purchase Agreement, price per share of preferred stock to be issued | $ / shares | $ 0.23 | ||||||
Mayne Pharma [Member] | Securities Purchase Agreement [Member] | Series A Warrants [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Warrant expiration period | 2 years | ||||||
Exercise price of warrants | $ / shares | $ 0.23 | ||||||
Warrants issued to purchase common stock | 5,434,783 | ||||||
Mayne Pharma [Member] | Securities Purchase Agreement [Member] | Series B Warrants [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Warrant expiration period | 5 years | ||||||
Exercise price of warrants | $ / shares | $ 0.275 | ||||||
Warrants issued to purchase common stock | 5,434,783 | ||||||
Mayne Pharma [Member] | Securities Purchase Agreement [Member] | Initial Closing [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Gross proceeds from sale of new common stock, preferred stock equity subordinate | $ | $ | $ 2,400,000 | ||||||
Mayne Pharma [Member] | Securities Purchase Agreement [Member] | Second Closing [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Gross proceeds from sale of new common stock, preferred stock equity subordinate | $ | $ | $ 1,600,000 | ||||||
Mayne Pharma [Member] | Securities Purchase Agreement [Member] | Third Closing [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Purchase Agreement, potential gross proceeds | $ | $ 1,000,000 | ||||||
Mayne Pharma [Member] | Securities Purchase Agreement [Member] | Series B Preferred Stock [Member] | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Dividends payable nature | Dividends are paid semi-annually as of June 30 (with a payment date of July 15) and December 31 (with a payment date of January 15) each year. The Company has the option in its discretion to pay dividends in cash or shares of common stock. If the Company elects to pay dividends in shares of common stock, the number of shares to be paid being calculated by dividing (i) the principal value of the dividend to be paid by (ii) the 6-month volume-weighted average price of the common stock prior to the measurement date (being 31 December, or 30 June) of the applicable year. |
Liquidity and Management's Pl_2
Liquidity and Management's Plans - Additional Information (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Cash and cash equivalents [Line Items] | |||
Cash and cash equivalents | $ 75,059 | $ 803,816 | $ 1,108,713 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 1 Months Ended | |||||
Dec. 31, 2020 | Sep. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Jun. 30, 2019 | Feb. 28, 2019 | |
Accounting Policies [Line Items] | ||||||
Cash, FDIC insured amount | $ 250,000 | |||||
Cash balance in excess of amount covered by Federal Deposit Insurance Corporation | 0 | |||||
Royalty [Member] | ||||||
Accounting Policies [Line Items] | ||||||
Deferred revenue | $ 3,000,000 | $ 3,000,000 | ||||
Black-Scholes Option Pricing Model [Member] | Options vesting grant date [Member] | ||||||
Accounting Policies [Line Items] | ||||||
Volatility rate | 87.50% | 86.98% | ||||
Risk-free interest rate | 0.39% | 0.28% | ||||
Weighted average expected life (in years) | 5 years | 5 years | ||||
Dividend yield | 0.00% | 0.00% | ||||
Black-Scholes Option Pricing Model [Member] | Options vesting on first anniversary of grant date [Member] | ||||||
Accounting Policies [Line Items] | ||||||
Volatility rate | 97.40% | 85.40% | ||||
Risk-free interest rate | 0.52% | 2.51% | ||||
Weighted average expected life (in years) | 5 years 6 months | 5 years 6 months | ||||
Dividend yield | 0.00% | 0.00% | ||||
Black-Scholes Option Pricing Model [Member] | Options vesting on february three two thousand twenty [Member] | ||||||
Accounting Policies [Line Items] | ||||||
Volatility rate | 70.00% | 85.30% | ||||
Risk-free interest rate | 1.73% | 1.83% | ||||
Weighted average expected life (in years) | 5 years | 5 years 3 months 18 days | ||||
Dividend yield | 0.00% | 0.00% |
Notes Payable - Additional Info
Notes Payable - Additional Information (Detail) - USD ($) | May 03, 2020 | May 02, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
Disclosure Of Long Term Notes Payable [Line Items] | ||||
Proceeds from notes payable | $ 41,600 | $ 0 | ||
Citibank [Member] | Paycheck Protection Program Loan [Member] | ||||
Disclosure Of Long Term Notes Payable [Line Items] | ||||
Proceeds from notes payable | $ 41,600 | |||
Debt instrument maturity date | May 2, 2022 | |||
Debt instrument stated interest rate | 1.00% |
Mayne Term Debt Facility - Addi
Mayne Term Debt Facility - Additional Information (Detail) - USD ($) | Dec. 12, 2020 | Dec. 31, 2020 | Dec. 14, 2020 |
Line of Credit Facility [Line Items] | |||
Credit facility outstanding | $ 55,000 | ||
Mayne Pharma [Member] | |||
Line of Credit Facility [Line Items] | |||
Credit facility aggregate Credit facility | $ 231,000 | ||
Credit facility interest rate description | US Bank Prime Rate plus 5.00% | ||
Credit facility instrument term | 24 months | ||
Credit facility amount drawn in first annual quarter | $ 81,000 | ||
Credit facility outstanding | 55,000 | ||
Credit facility amount drawn in second and third annual quarters | 75,000 | ||
Credit facility draw down payment | $ 25,000 | ||
Credit facility covenant terms | (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 is outstanding at December 31, 2020) 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, $75,000 may be drawn in the second and third annual quarters of the Facility, respectively. | ||
Credit facility covenant compliance | An event of default under the Loan Agreement includes, among other things, (i) the Company breaches its obligations under the Loan Agreement, and where that breach is capable of remedy it does not remedy the breach within 20 business days after receipt of a notice from the Mayne Pharma of the breach, (ii) Mayne Pharma validly terminates the Third Amended and Restated Supply and License Agreement dated December 17, 2018 between the Company and Mayne Pharma, or (iii) the Company becomes insolvent, including by becoming the subject of the filing or institution of bankruptcy, liquidation or dissolution proceedings. |
Income Taxes - The Difference B
Income Taxes - The Difference Between Expected Income Tax Benefits and Income Tax Benefit Recorded in The Financial Statements (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Income taxes benefit computed at statutory rate | $ (222,165) | $ (574,005) |
State income tax benefit, net | (45,967) | (112,934) |
Other | (13,668) | 40,085 |
Change in valuation allowance | 281,800 | 646,854 |
Expected income tax benefits and income tax benefits recorded | $ 0 | $ 0 |
Income Taxes - Components of De
Income Taxes - Components of Deferred Income Tax Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Income Tax Disclosure [Abstract] | ||
In-process research and development | $ 742,574 | $ 736,325 |
Net operating loss carry forward | 6,608,114 | 6,425,461 |
R&D credit | 190,515 | 339,052 |
Share-based compensation | 34,231 | 33,943 |
Other | 6,060 | 2,742 |
Deferred tax assets gross | 7,581,494 | 7,537,523 |
Less: valuation allowance | (7,581,494) | (7,537,523) |
Deferred tax assets, net | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes [Line Items] | ||
Percentage of valuation allowance against deferred tax assets | 100.00% | 100.00% |
Valuation Allowance, Methodologies and Assumptions | In accordance with GAAP, it is required that a deferred tax asset be reduced by a valuation allowance if, based on the weight of available evidence it is more likely than not (a likelihood of more than 50 percent) that some portion or all of the deferred tax assets will not be realized. | |
NOLs used to offset taxable income | $ 35,000 | |
Minimum [Member] | ||
Income Taxes [Line Items] | ||
Valuation Allowance, Assumption Percentage | 50.00% | 50.00% |
Domestic Tax Authority [Member] | ||
Income Taxes [Line Items] | ||
Net operating loss carryforward | $ 26,100,000 | |
State and Local Jurisdiction [Member] | ||
Income Taxes [Line Items] | ||
Net operating loss carryforward | $ 26,100,000 | |
Operating loss carryforward expiration period | Dec. 31, 2020 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Stock Option Activity (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of Shares, Outstanding, Beginning Balance | 5,002,685 | 3,424,000 |
Number of Shares, Exercised | 0 | 0 |
Number of Shares, Forfeitures | 0 | (1,616,842) |
Number of Shares, Outstanding, Ending Balance | 13,349,461 | 5,002,685 |
Weighted Average Exercise Price per Share, Outstanding, Beginning Balance | $ 0.19 | $ 0.28 |
Weighted Average Exercise Price per Share, Exercised | 0 | 0 |
Weighted Average Exercise Price per Share, Forfeitures | 0 | 0.15 |
Weighted Average Exercise Price per Share, Outstanding, Ending Balance | $ 0.10 | $ 0.19 |
Aggregate Intrinsic Value, Outstanding, Beginning Balance | $ 1,260 | $ 0 |
Aggregate Intrinsic Value, Outstanding, Ending Balance | $ 14,587 | $ 1,260 |
Directors and Officers [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of Shares, Granted | 8,346,776 | 3,195,527 |
Weighted Average Exercise Price per Share, Granted | $ 0.04 | $ 0.07 |
Aggregate Intrinsic Value, Granted |
Stockholders' Equity - Informat
Stockholders' Equity - Information Regarding Stock Options Outstanding and Exercisable (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number Outstanding | 13,349,461 | 5,002,685 | 3,424,000 |
Weighted Average Exercise Price | $ 0.10 | $ 0.19 | $ 0.28 |
Aggregate Intrinsic Value | $ 14,587 | ||
Number Outstanding | 8,849,461 | ||
Aggregate Intrinsic Value | $ 14,587 | ||
Range 01 [Member] | |||
Range of Exercise Prices | $ 0.03 | ||
Range of Exercise Prices | $ 0.10 | ||
Number Outstanding | 10,555,461 | ||
Weighted Average Remaining Contractual Life (Years) | 9 years 3 months 10 days | ||
Weighted Average Exercise Price | $ 0.05 | ||
Aggregate Intrinsic Value | $ 14,587 | ||
Range of Exercise Prices | $ 0.03 | ||
Range of Exercise Prices | $ 0.10 | ||
Number Outstanding | 6,055,461 | ||
Weighted Average Remaining Contractual Life (Years) | 9 years 3 months 25 days | ||
Weighted Average Exercise Price | $ 0.05 | ||
Aggregate Intrinsic Value | $ 14,587 | ||
Range 02 [Member] | |||
Range of Exercise Prices | $ 0.11 | ||
Range of Exercise Prices | $ 0.30 | ||
Number Outstanding | 2,167,000 | ||
Weighted Average Remaining Contractual Life (Years) | 6 years 8 months 8 days | ||
Weighted Average Exercise Price | $ 0.26 | ||
Aggregate Intrinsic Value | $ 0 | ||
Range of Exercise Prices | $ 0.11 | ||
Range of Exercise Prices | $ 0.30 | ||
Number Outstanding | 2,167,000 | ||
Weighted Average Remaining Contractual Life (Years) | 6 years 8 months 8 days | ||
Weighted Average Exercise Price | $ 0.26 | ||
Aggregate Intrinsic Value | $ 0 | ||
Range 03 [Member] | |||
Range of Exercise Prices | $ 0.31 | ||
Range of Exercise Prices | $ 0.33 | ||
Number Outstanding | 627,000 | ||
Weighted Average Remaining Contractual Life (Years) | 7 years 5 months 15 days | ||
Weighted Average Exercise Price | $ 0.33 | ||
Aggregate Intrinsic Value | $ 0 | ||
Range of Exercise Prices | $ 0.31 | ||
Range of Exercise Prices | $ 0.33 | ||
Number Outstanding | 627,000 | ||
Weighted Average Remaining Contractual Life (Years) | 7 years 5 months 15 days | ||
Weighted Average Exercise Price | $ 0.33 | ||
Aggregate Intrinsic Value | $ 0 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Non-vested Stock Option Activity (Detail) | 12 Months Ended |
Dec. 31, 2020USD ($)$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Abstract] | |
Begining Balance, Non-vested | 2,208,685 |
Granted | 4,500,000 |
Vested | (2,208,685) |
Forfeited | 0 |
Ending Balance, Non-vested | 4,500,000 |
Weighted Average Exercise Price Per Share | $ / shares | $ 0.05 |
Aggragate Intrinsic Value | $ | $ 0 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock based compensation expense related to Restricted Stock Units and stock options | $ 228,861 | $ 269,924 | |
Number of outstanding common stock warrants | 50,270,563 | ||
Weighted average exercise price of outstanding common stock warrants | $ 0.13 | ||
Weighted average remaining life of outstanding common stock warrants | 6 months | ||
Weighted average grant date fair value of options granted | $ 0.03 | $ 0.05 | |
Restricted Stock Units (RSUs) [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock based compensation expense related to Restricted Stock Units and stock options | $ 228,861 | $ 269,924 | |
Unamortized stock-based compensation cost related to unpaid RSUs | $ 40,000 | ||
Employee Stock Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options granted vesting period | 3 years | ||
Period during which options are exercisable | 10 years | ||
Employee Stock Option [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price as percentage of fair market value of shares | 100.00% | ||
More Than 10% Common Stock Owners [Member] | Employee Stock Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price as percentage of fair market value of shares | 110.00% | ||
Minimum percentage of the company's voting stock ownership for 110% exercise price of stock options | 10.00% | ||
More Than 10% Common Stock Owners [Member] | Employee Stock Option [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Period during which options are exercisable | 5 years | ||
Two Thousand Fourteen Equity Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares authorized to be issued under Equity Incentive Plan | 32,583,475 | ||
Two Thousand Fourteen Equity Incentive Plan [Member] | Mayne Pharma [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock option awards | 43,583,475 | ||
Stock options awarded, Shares | 11,000,000 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - Mayne Pharma [Member] - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Related Party Transaction [Line Items] | ||
Due to Mayne Pharma | $ 0 | $ 0 |
Due from Mayne Pharma | $ 0 | $ 0 |