UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark one)
| | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
| | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ______ to ______
Commission File Number
TIMBER PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| | |
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
(Address of principal executive offices and zip code)
(
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| | | | | The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically, if any, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large Accelerated Filer ☐ | | Accelerated Filer ☐ |
| | | Smaller Reporting Company |
| Emerging growth company | | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻
Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.
| Class of Common Stock | Outstanding Shares as of May [ ], 2023 | |
| Common Stock, $0.001 par value | |
TIMBER PHARMACEUTICALS, INC. & SUBSIDIARIES
Form 10-Q
For the Quarter Ended March 31, 2023
Table of Contents
PART I – FINANCIAL INFORMATION
Timber Pharmaceuticals, Inc. & Subsidiaries
Condensed Consolidated Balance Sheets
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash | $ | $ | ||||||
| Prepaid research and development | ||||||||
| Other current assets | ||||||||
| Total current assets | ||||||||
| Deposits | ||||||||
| Property and equipment, net | ||||||||
| Right of use asset | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Lease liability, current portion | ||||||||
| Short-term milestone payable due to Patagonia Pharmaceuticals LLC | ||||||||
| Total current liabilities | ||||||||
| Lease liability | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 7) | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock par value $; shares authorized, shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | ||||||||
| Common stock, par value $; shares authorized; shares issued and outstanding as of March 31, 2023, and shares issued and outstanding as of December 31, 2022 | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders' equity | ||||||||
| Total liabilities and stockholders' equity | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Timber Pharmaceuticals, Inc. & Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
| Three months ended March 31, |
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| 2023 |
2022 |
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| Grant revenue |
$ | $ | ||||||
| Operating costs and expenses |
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| Research and development |
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| Selling, general and administrative |
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| Total operating expenses |
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| Loss from operations |
( |
) | ( |
) | ||||
| Other income (expense) |
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| Interest expense |
( |
) | ( |
) | ||||
| Other income |
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| Forgiveness of PPP loan |
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| Gain on foreign currency exchange |
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| Total other income (expense) |
( |
) | ||||||
| Net loss and comprehensive loss |
( |
) | ( |
) | ||||
| Net loss attributable to common stockholders |
$ | ( |
) | $ | ( |
) | ||
| Basic and diluted net loss per share attributable to common stockholders |
$ | ( |
) | $ | ( |
) | ||
| Basic and diluted weighted average number of shares outstanding |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Timber Pharmaceuticals, Inc. & Subsidiaries
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(Unaudited)
For the Three Months Ended March 31, 2023
| Total | ||||||||||||||||||||||||||||
| Series B Preferred Stock | Common Stock | Additional | Accumulated | Stockholders' | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Paid-in Capital | Deficit | Equity (Deficit) | ||||||||||||||||||||||
| Balance at January 1, 2023 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| Stock-based compensation | ||||||||||||||||||||||||||||
| Exercise of TardiMed Warrants | ||||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||
| Balance at March 31, 2023 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
For the Three Months Ended March 31, 2022
| Series B Preferred Stock |
Common Stock |
Additional |
Accumulated |
Total |
||||||||||||||||||||||||
| Shares |
Amount |
Shares |
Amount |
Paid-in Capital |
Deficit |
Stockholder's Equity |
||||||||||||||||||||||
| Balance at January 1, 2022 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||
| Stock-based compensation |
— | — | ||||||||||||||||||||||||||
| Exercise of VARs |
( |
) | ( |
) | ||||||||||||||||||||||||
| Net loss |
— | — | ( |
) | ( |
) | ||||||||||||||||||||||
| Balance at March 31, 2022 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
Timber Pharmaceuticals, Inc. & Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| Three months ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | ||||||||
| Amortization of right of use assets | ||||||||
| Depreciation | ||||||||
| Forgiveness of PPP loan | ( | ) | ||||||
| Non-cash interest on redeemable preferred stock | ||||||||
| Changes in assets and liabilities: | ||||||||
| Prepaid research and development | ||||||||
| Other current assets | ||||||||
| Deposits | ( | ) | ||||||
| Accounts payable | ( | ) | ( | ) | ||||
| Accrued expenses | ( | ) | ( | ) | ||||
| Lease liability | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of property and equipment | ( | ) | ( | ) | ||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities | ||||||||
| Net cash provided by financing activities | ||||||||
| Net decrease in cash | ( | ) | ( | ) | ||||
| Cash, beginning of period | ||||||||
| Cash, end of period | $ | $ | ||||||
| Non-cash investing and financing activities: | ||||||||
| Cashless exercise of VARs | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note 1. Organization and description of business operations
Timber Pharmaceuticals, Inc., formerly known as BioPharmX Corporation (together with its subsidiaries Timber Pharmaceuticals Australia Pty Ltd., BioPharmX Inc. and Timber Pharmaceuticals LLC, the “Company” or “Timber”) is incorporated under the laws of the state of Delaware. Timber was founded in 2019 to develop treatments for unmet needs in medical dermatology. Timber has a particular focus on rare diseases or conditions of the skin for which there are no current treatments. Timber is initially targeting multiple indications in rare/orphan dermatology with no approved treatments.
On November 7, 2022, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended (the “Certificate of Amendment”), with the Secretary of State of Delaware that effected a
These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes in Item 8 of Part II, “Financial Statements and Supplementary Data,” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
Merger Agreement
On May 18, 2020, BioPharmX Corporation (“BioPharmX”) completed its business combination with Timber Pharmaceuticals LLC, a Delaware limited liability company (“Timber Sub”), in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of January 28, 2020 by and among BioPharmX, Timber Sub and BITI Merger, Inc., a Delaware corporation and wholly-owned subsidiary of BioPharmX (“Merger Sub”), as amended on March 24, 2020 and subsequently amended on April 27, 2020 as amended (the “Merger Agreement”), pursuant to which Merger Sub merged with and into Timber Sub, with Timber Sub surviving as a wholly-owned subsidiary of the Company (the “Merger”). In connection with, and immediately prior to the completion of, the Merger, BioPharmX effected a reverse stock split of the shares of common stock at a ratio of 1-for-12 (the “2020 Reverse Stock Split”). Following the completion of the Merger, BioPharmX changed its name to “Timber Pharmaceuticals, Inc.” and the officers and directors of Timber Sub became the officers and directors of the Company.
In connection with the Merger, the
In connection with the Merger Agreement, on March 27, 2022, Timber Sub and BioPharmX entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain accredited investors (the “Investors”) pursuant to which Timber Sub issued to the Investors shares of Timber units immediately prior to the Merger and we issued to the Investors warrants to purchase shares of common stock on the tenth trading day following the consummation of the Merger (the “Investor Warrants”) in a private placement transaction for an aggregate purchase price of approximately $
In addition, pursuant to the terms of the Securities Purchase Agreement, the Company issued to the Investors, on May 22, 2020, warrants to purchase
Investor Warrants
Series A Warrants
The Series A Warrants have an exercise price of $
Pursuant to the Series A Warrants, the Company agreed not to enter into, allow or be party to certain fundamental transactions, generally including any merger with or into another entity, sale of all or substantially all of the Company’s assets, tender offer or exchange offer, or reclassification of the common stock (a “Fundamental Transaction”) until May 1, 2021. Thereafter, upon any exercise of a Series A Warrant, the holder shall have the right to receive, for each share of common stock that would have been issuable upon such exercise immediately prior to the occurrence of a Fundamental Transaction, at the option of the holder (without regard to any limitation on the exercise of the Series A Warrant), the number of shares of common stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration (the “Alternate Consideration”) receivable as a result of such Fundamental Transaction by a holder of the number of shares of common stock for which the Series A Warrant is exercisable immediately prior to such Fundamental Transaction (without regard to any limitation on the exercise of the Series A Warrant). For purposes of any such exercise, the determination of the exercise price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one share of common stock in such Fundamental Transaction, and the Company shall apportion the exercise price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of common stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of the Series A Warrant following such Fundamental Transaction. The Company shall cause any successor entity in a Fundamental Transaction in which the Company is not the survivor (the “Successor Entity”) to assume in writing all of the obligations of the Company under the Series A Warrants, upon which the Series A Warrants shall become exercisable for shares of common stock, shares of the common stock of the Successor Entity or the consideration that would have been issuable to the holders had they exercised the Series A Warrants prior to such Fundamental Transaction, at the holders’ election. Additionally, at the request of a holder delivered before the 90th day after the consummation of a Fundamental Transaction, the Company must purchase such holder’s warrant for the value calculated using the Black-Scholes option pricing model as of the day immediately following the public announcement of the applicable Fundamental Transaction, or, if the Fundamental Transaction is not publicly announced, the date the Fundamental Transaction is consummated.
If the Company fails to issue to a holder of Series A Warrants the number of shares of common stock to which such holder is entitled upon such holder’s exercise of the Series A Warrants, then the Company shall be obligated to pay the holder on each day while such failure is continuing an amount equal to
Further, the Series A Warrants provide that, in the event that the Company does not have sufficient authorized shares to deliver in satisfaction of an exercise of a Series A Warrant, then unless the holder elects to void such attempted exercise, the holder may require the Company to pay an amount equal to the product of (i) the number of shares that the Company is unable to deliver and (ii) the highest volume-weighted average price of a share of common stock as quoted on the NYSE American during the period beginning on the date of such attempted exercise and ending on the date that the Company makes the applicable payment.
On November 19, 2020, the Company entered into waiver agreements with each of the holders of the Company’s Series A Warrants. Pursuant to the waiver agreements the holders agreed to waive certain provisions in the Series A Warrants in order to allow for one immediate and final reset of the number of shares of common stock underlying the Series A Warrants and the exercise price of the Series A Warrants, and permanently waive the provisions providing for future resets of the number of shares of common stock underlying the Series A Warrants and the exercise price of the Series A Warrants (other than the anti-dilution protection provisions in the Series A Warrants providing for adjustments to the exercise price of the Series A Warrants upon a dilutive issuance). As a result, the exercise price of the Series A Warrants was set at $
Series B Warrants
The Series B Warrants had an exercise price of $
On November 19, 2020 the Company entered into waiver agreements with each of the holders of the Company’s Series B Warrants. Pursuant to the waiver agreements the holders agreed to waive certain provisions in the Warrants in order to allow for one immediate and final reset of the number of shares of common stock underlying the Series B Warrants. As a result, the number of shares underlying all of the Series B Warrants was set at
The number of shares underlying a holder’s Series B Warrants was calculated using the existing formula set forth in the Series B Warrants and was reached by dividing the initial purchase price paid by the holder under the Purchase Agreement by a “Reset Price”, equal to the arithmetic average of the five (5) lowest Weighted Average Prices (as defined in the Warrants) of the common stock during the applicable “Reset Period,” in this case being the nine Trading Day (as defined in the Warrants) period ending on the Effective Date (but not less than the Reset Floor Price), and subtracting from such quotient the number of shares of common stock issued (or that were issuable) under the Purchase Agreement to the holder.
Bridge Warrants
The Bridge Warrants were issued on May 22, 2020, to the Bridge Investors, had an exercise price of $
The Bridge Warrants provide that if Timber issues or sells or in accordance with the terms of the Bridge Warrants, is deemed to have issued or sold any shares of common stock for a price per share lower than the exercise price then in effect subject to certain limited exceptions, then the exercise price of the Bridge Warrants shall be reduced to such lower price per share.
Upon the consummation of a Fundamental Transaction by the Company, upon any exercise of a Bridge Warrant, the holder shall have the right to receive, for each share of common stock that would have been issuable upon such exercise immediately prior to the occurrence of a Fundamental Transaction, at the option of the holder (without regard to any limitation on the exercise of the Bridge Warrant), the number of shares of common stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration (the “Alternate Consideration”) receivable as a result of such Fundamental Transaction by a holder of the number of shares of common stock for which the Bridge Warrant is exercisable immediately prior to such Fundamental Transaction (without regard to any limitation on the exercise of the Bridge Warrant). For purposes of any such exercise, the determination of the exercise price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one share of common stock in such Fundamental Transaction, and the Company shall apportion the exercise price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of common stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of the Bridge Warrant following such Fundamental Transaction. The Company shall cause any Successor Entity to assume in writing all of the obligations of the Company under the Bridge Warrants, upon which the Bridge Warrants shall become exercisable for shares of common stock, shares of the common stock of the Successor Entity or the consideration that would have been issuable to the holders had they exercised the Bridge Warrants prior to such Fundamental Transaction, at the holders’ election.
Additionally, at the request of a holder of a Bridge Warrant delivered before the 90th day after the consummation of a Fundamental Transaction, Timber or the successor entity must purchase such holder’s warrant for the value calculated using the Black-Scholes option pricing model as of the day immediately following the public announcement of the applicable Fundamental Transaction, or, if the Fundamental Transaction is not publicly announced, the date the Fundamental Transaction is consummated.
The Bridge Warrants also contain a “cashless exercise” feature that allows the holders to exercise the Bridge Warrants without making a cash payment in the event that there is no effective registration statement registering the shares issuable upon exercise of the Bridge Warrants. The Bridge Warrants are subject to a blocker provision which restricts the exercise of the Bridge Warrants if, as a result of such exercise, the holder, together with its affiliates and any other person whose beneficial ownership of common stock would be aggregated with the holder’s for purposes of Section 13(d) of the Exchange Act would beneficially own in excess of
November 2021 Offering
On November 2, 2021, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), as representative of the several underwriters named in Schedule I thereto, relating to the public offering, issuance and sale of
Each share of common stock and pre-funded warrant to purchase
August 2022 Offering
On March 1, 2022, the Company entered into an engagement agreement, as subsequently amended on June 30, 2022 (the “Engagement Agreement”), with Wainwright, pursuant to which Wainwright agreed to act as the Company’s exclusive placement agent on a reasonable best efforts basis in connection with a public offering of the Company’s common stock, par value $
On August 4, 2022, the Company announced the pricing of the public offering (the “August 2022 Offering”) of (i)
In connection with the August 2022 Offering, on August 4, 2022, the Company entered into securities purchase agreements with certain institutional investors in the August 2022 Offering. The net proceeds to the Company from the August 2022 Offering were approximately $
October 2022 Offering
On October 3, 2022, the Company entered into a Securities Purchase Agreement (the “October Purchase Agreement”) with several institutional accredited investors (the “October Investors”) to sell, in a registered direct offering (the “Registered Offering”) (i)
The Company filed a prospectus supplement (the “Prospectus Supplement”) on October 3, 2022, with the Securities and Exchange Commission (the “SEC”) in connection with the Registered Offering. The shares of common stock and Series 1 Warrant Shares were offered pursuant to a “shelf” registration statement on Form S-3 (Registration No.333-255743) (the “Registration Statement”), which was declared effective by the SEC on May 11, 2021, the accompanying base prospectus dated May 11, 2021 contained within the Registration Statement, and the Prospectus Supplement.
In a concurrent private placement (the “Concurrent Private Placement Offering” and, together with the Registered Offering, the “October 2022 Offerings”) the Company has also agreed to issue (i) Series 2 common warrants (the “Series 2 Warrants, “and together with the Series 1 Warrants, the “Warrants”) to purchase up to an aggregate of
Each share of Series B Preferred Stock has a stated value of $
The Series 2 Warrants are exercisable on the date six (6) months following the date of issuance at an exercise price of $
As compensation to Wainwright, as the exclusive placement agent in connection with the Registered Offering, the Company paid Wainwright a cash fee of
Special Meeting and 2022 Reverse Stock Split
On November 7, 2022, the Special Meeting, the stockholders approved a proposal to amend the Company’s certificate of incorporation to effect a reverse split of the common stock at a specific ratio, ranging from one-for-
On November 7, 2022, the Company filed the Certificate of Amendment with the Secretary of State of the State of Delaware, which effected, at 5:00 p.m. Eastern Time on November 8, 2022, the 2022 Reverse Stock Split of the Company’s issued and outstanding shares common stock at a ratio of one-for-fifty. In connection with the 2022 Reverse Stock Split, the CUSIP number for the common stock changed to 887080208.
As a result of the 2022 Reverse Stock Split, every
Liquidity and Capital Resources
The Company has no product revenues, incurred operating losses since inception, and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. The Company had an accumulated deficit of approximately $
Going Concern
The Company has evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year beyond the filing of this Quarterly Report on Form 10-Q. Based on such evaluation and the Company's current plans, which are subject to change, management believes there is substantial doubt about the Company's ability to continue as a going concern. The Company's existing cash and cash equivalents as of March 31, 2023, were sufficient only to satisfy our operating cash needs through the second quarter of 2023. Thus, the Company’s current cash on hand at March 31, 2023, was potentially not sufficient to satisfy our operating cash needs for the twelve months from the filing of this Quarterly Report on Form 10-Q.
The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern.
The Company’s future liquidity and capital funding requirements will depend on numerous factors, including:
| ● | its ability to raise additional funds to finance its operations, including its ability to access financing that may be unavailable due to contractual limitations under the Securities Purchase Agreement; |
| ● | the outcome, costs and timing of clinical trial results for the Company’s current or future product candidates, including the timing, progress, costs and results of its Phase 3 clinical trial of TMB-001 for the treatment of congenital ichthyosis; |
| ● | the outcome, timing and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities; |
| ● | the emergence and effect of competing or complementary products; |
| ● | its ability to maintain, expand and defend the scope of its intellectual property portfolio, including the amount and timing of any payments the Company may be required to make, or that it may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; |
| ● | the cost and timing of completion of commercial-scale manufacturing activities if any of its products are approved for commercial sale; |
| ● | the cost of establishing sales, marketing and distribution capabilities for its products in regions where it chooses to commercialize its products on its own; |
| ● | the initiation, progress, timing and results of the commercialization of its product candidates, if approved for commercial sale, if approved for commercial sale; |
| ● | its ability to retain its current employees and the need and ability to hire additional management and scientific and medical personnel; and, |
| ● | the terms and timing of any collaborative, licensing or other arrangements that it has or may establish. |
The Company will need to raise substantial additional funds through one or more of the following: issuance of additional debt or equity and/or the completion of a licensing or other commercial transaction for one or more of the Company's product candidates. If the Company is unable to maintain sufficient financial resources, its business, financial condition and results of operations will be materially and adversely affected. This could affect future development and business activities and potential future clinical studies and/or other future ventures. There can be no assurance that the Company will be able to obtain the needed financing on acceptable terms or at all. Additionally, equity or convertible debt financings will likely have a dilutive effect on the holdings of the Company's existing stockholders.
Note 2. Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the SEC. In the opinion of management, the accompanying unaudited condensed financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results.
The results for the unaudited condensed consolidated statement of operations are not necessarily indicative of results to be expected for the year ending December 31, 2023, or for any future interim period. The unaudited condensed consolidated financial statements do not include all of the information and notes required by U.S. GAAP for complete financial statements.
Effective at 5:00 PM (EST) on November 8, 2022 the Company effected a 1-for-
Use of Estimates
The preparation of financial statements in conformity with GAAP 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 expenses during the reporting period. The most significant estimates in the Company’s unaudited condensed consolidated financial statements relate to the valuations of warrants, and equity-based awards. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Reclassifications
Certain reclassifications have been made to the condensed consolidated financial statements of prior years to conform to the current year presentation.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include cash held in banks and money market mutual funds. The Company had
Property and Equipment
Property and equipment are recorded at cost and depreciated over their estimated useful life on a straight-line basis as follows:
Furniture -
Computer Equipment -
Research and Development
Research and development costs, including in-process research and development acquired as part of an asset acquisition for which there is no alternative future use, are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.
Accrued Outsourcing Costs
Substantial portions of the Company’s preclinical studies and clinical trials are performed by third-party laboratories, medical centers, contract research organizations and other vendors (collectively “CROs”). These CROs generally bill monthly or quarterly for services performed, or bill based upon milestone achievement. For preclinical studies, the Company accrues expenses based upon estimated percentage of work completed and the contract milestones remaining. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. The Company outsources a substantial portion of its clinical trial activities, utilizing external entities such as CROs, independent clinical investigators, and other third-party service providers to assist the Company with the execution of its clinical studies. For each clinical trial that the Company conducts, certain clinical trial costs are expensed immediately, while others are expensed over time based on the number of patients in the trial, the attrition rate at which patients leave the trial, and/or the period over which clinical investigators or CROs are expected to provide services. The Company’s estimates depend on the timeliness and accuracy of the data provided by the CROs regarding the status of each program and total program spending. The Company periodically evaluates the estimates to determine if adjustments are necessary or appropriate based on information it receives.
Fair Value Measurement
The Company follows the accounting guidance in ASC 820 for its fair value measurements of financial assets and liabilities measured at fair value on a recurring basis. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.
The accounting guidance requires fair value measurements be classified and disclosed in one of the following three categories:
Level 1: Quoted prices in active markets for identical assets or liabilities.
Level 2: Observable inputs other than Level 1 prices, for similar assets or liabilities that are directly or indirectly observable in the marketplace.
Level 3: Unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
As of March 31, 2023, and December 31, 2022, the recorded values of prepaid expenses, accounts payable and accrued expenses, approximate the fair values due to the short-term nature of the instruments.
Leases
The Company accounts for its leases under the Financial Accounting Standards Board Accounting Standards Codification (“ASC”) 842, Leases (“ASC 842”). Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheet as both a right of use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right of use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right of use asset result in straight-line rent expense over the lease term.
In calculating the right of use asset and lease liability, the Company elects to combine lease and non-lease components as permitted under ASC 842. The Company excludes short-term leases having initial terms of 12 months or less from the new guidance as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term.
Revenue Recognition
The Company has not yet generated any revenue from product sales. The Company’s source of revenue in 2022 had been from a grant. When grant funds are received after costs have been incurred, the Company records grant revenue upon the receipt of cash.
Warrants
The Company estimates the fair value of certain common stock warrants using a Black-Scholes option pricing model, and the assumptions used in calculating the fair value of such warrants represented management’s best estimates and involve inherent uncertainties and the application of management’s judgment. The fair value of common stock warrants has been recorded in equity as additional paid-in-capital.
Stock-Based Compensation
The Company accounts for stock-based compensation in accordance with ASC 718, “Compensation—Stock Compensation,” which requires the measurement and recognition of compensation expense based on estimated fair market values for all share-based awards made to employees and directors, including stock options. The Company expenses stock-based compensation to employees, non-employees and members of the Board over the requisite service period based on the estimated grant-date fair value of the awards and actual forfeitures. The Company accounts for forfeitures as they occur. Stock-based awards with graded-vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. All stock-based compensation costs are recorded in general and administrative or research and development costs in the consolidated statements of operations based upon the underlying individual’s role at the Company.
Series A Preferred Stock Under Redemption
The Series A Preferred Stock under redemption was subject to certain limitations under Delaware law. Each share of Series A Preferred Stock was convertible at any time at the holder’s option into a number of shares of common stock (subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions as specified in the Certificate of Designations) at a conversion price $
On November 23, 2021, the Company received a request for redemption by TardiMed Sciences LLC (“TardiMed”) for the Series A Preferred Stock. The Company’s Series A Preferred Stock, was redeemable at December 31, 2021 subject to certain limitations under Delaware law, and was recorded at the redemption value of $
On July 27, 2022, the Company, entered into a letter agreement (the “Letter Agreement”) with TardiMed pursuant to which TardiMed agreed to exchange its
Twenty percent of the TardiMed Warrant was immediately exercisable upon issuance. Beginning on September 30, 2022, and then at the end of each subsequent calendar quarter upon written request of TardiMed, the Company has agreed to allow an additional
Pursuant to the Letter Agreement, TardiMed released and discharged the Company and its affiliates from any and all claims, rights, demands, actions, suits, causes of action, liabilities, obligations, damages and costs of any nature whatsoever that TardiMed has, had or may have against the Company or related parties in any way arising from or related to the Series A Preferred Stock. As of March 31, 2023, the TardiMed Warrant was exercisable for
Loss Per Share
Basic net income (loss) per share (“EPS”) of common stock is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding during the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity.
To calculate the basic EPS numerator, income available to common stockholders must be computed by deducting both the dividends declared in the period on preferred stock (whether or not paid) and the dividends accumulated for the period on cumulative preferred stock (whether or not declared) from income from continuing operations and also from net income.
If there is a loss from continuing operations or a net loss, the amount of the loss shall be increased by those preferred dividends. The Series A Preferred Stock had cumulative dividends, whether or not declared. Accordingly, the Company reduced the numerator for basic EPS by deducting/(increasing) the amount of cumulative preferred dividend from net income/(loss) in each period presented prior to the Company’s Series A Preferred Stock becoming redeemable, which occurred in 2021. No dividends accrued on the Company’s Series A Preferred Stock during 2022 prior to the Warrant Exchange.
The basic and diluted net loss amounts are the same for the three months ended March 31, 2023 and 2022, respectively, as a result of the net loss and anti-dilutive impact of the potentially dilutive securities. Potentially dilutive shares are determined by applying the treasury stock method to the assumed exercise of outstanding stock options, value appreciation rights, and warrants. Potentially dilutive shares that were issuable upon conversion of the Series A Preferred Stock prior to the Warrant Exchange were calculated using the if-converted method.
As a result of the 2022 Reverse Stock Split, the Company has retroactively restated the basic and diluted weighted average number of shares outstanding.
The following is a reconciliation of the numerator and denominator of the diluted net income (loss) per share computations for the periods presented below:
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Basic and diluted loss per share: | ||||||||
| Net (loss) income | $ | ( | ) | $ | ( | ) | ||
| Net (loss) income attributable to common stockholders | $ | ( | ) | $ | ( | ) | ||
| Basic and diluted weighted average number of shares outstanding | ||||||||
| Basic and Diluted net (loss) per share attributable to common stockholders | $ | ( | ) | $ | ( | ) | ||
Securities that could potentially dilute income per share in the future were not included in the computation of diluted loss per share for the three-month periods ended March 31, 2023, and 2022, respectively, because their inclusion would be anti-dilutive are as follows (unaudited):
| March 31, | ||||||||
| 2023 | 2022 | |||||||
| Series A warrants | ||||||||
| Bridge warrants | ||||||||
| Value appreciation rights | ||||||||
| Options to purchase common stock | ||||||||
| Series A preferred stock (if converted) | ||||||||
| Legacy stock options | ||||||||
| Legacy warrants | ||||||||
| Warrants issued in the November 2021 Financing | ||||||||
| Warrants issued in the August 2022 Financing | ||||||||
| Warrants issued with October 2022 Financing | ||||||||
| Restricted Stock Units | ||||||||
Income taxes
Income taxes are accounted for under the asset and liability method. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more-likely than not that some or all of the deferred tax assets will not be realized. The Company also follows the provisions of accounting for uncertainty in income taxes which prescribes a model for the recognition and measurement of a tax position taken or expected to be taken in a tax return, and provides guidance on derecognition, classification, interest and penalties, disclosure and transition. In accordance with this guidance, tax positions must meet a more likely than not recognition threshold and measurement attribute for the financial statement recognition and measurement of tax position.
The Company’s policy is to account for income tax related interest and penalties in income tax expense in the accompanying consolidated statements of operations.
The Company made no state income tax payments during the three-month periods ended March 31, 2023 and 2022, respectively.
Recent accounting pronouncements
The Company did adopt any new Accounting Standard Updates during the quarter ended March 31, 2023.
Note 3. Purchases of Assets
Acquisition of Intellectual Property Rights from Patagonia Pharmaceuticals LLC (“Patagonia”)
On February 28, 2019, the Company acquired the intellectual property rights to a topical formulation of isotretinoin for the treatment of congenital ichthyosis and identified as TMB-001, formerly PAT-001, from Patagonia (the “TMB-001 Acquisition”) pursuant to an asset acquisition agreement (the “Asset Acquisition Agreement”).
Upon closing of the TMB-001 Acquisition, the Company paid a one-time upfront payment of $
On July 20, 2022, the Company entered into an amendment to the Asset Acquisition Agreement with Patagonia (the “Amendment”). Pursuant to the Amendment, the Company and Patagonia extended the time for the Company’s payment of the first milestone payment, which became payable upon the Company commencing patient enrollment in its Phase 3 ASCEND clinical trial in the second quarter of 2022. The first milestone payment became payable by the Company in
On June 26, 2019, the Company acquired the intellectual property rights to a locally administered formulation of Sitaxsentan for the treatment of cutaneous fibrosis and/or pigmentation disorders, and identified as TMB-003, formerly PAT-S03, from Patagonia (the “TMB-003 Acquisition”).
Upon closing of the TMB-003 Acquisition, the Company paid a one-time upfront payment of $
On January 12, 2021, the Company announced that the FDA had granted orphan drug designation to TMB-003.
Acquisition and Termination of License from AFT Pharmaceuticals Limited (“AFT”)
On July 5, 2019, the Company and AFT entered into a license agreement which provides the Company with (i) an exclusive license to certain licensed patents, licensed know-how and AFT trademarks to commercialize a proprietary topical formulation of rapamycin marketed under the brand name Pascomer (“Pascomer”) in the United States, Canada and Mexico and (2) a co-exclusive license to develop Pascomer in this territory. Concurrently, the Company granted to AFT an exclusive license to commercialize Pascomer outside of the Company’s territory and co-exclusive sublicense to develop and manufacture the licensed product for commercialization outside of the Company’s territory (the "AFT License Agreement").
The development of Pascomer had been conducted pursuant to a written development plan, written by AFT and approved by the joint steering committee, which is reviewed on at least an annual basis. AFT agreed to perform clinical trials of Pascomer in the specified territory and perform all CMC (chemistry, manufacturing and controls) and related activities to support regulatory approval. The Company was responsible for all expenses incurred by AFT during the term of the AFT License Agreement and equally shared all costs and expenses with AFT, incurred by AFT for development and marketing work performed in furtherance of regulatory approval and commercialization worldwide, outside of the specified territory. The Company was entitled to receive 50% of the economics (royalties and milestones) in any licensing transaction that AFT executed outside of North America, Australia, New Zealand, and Southeast Asia. In March 2021 the Company announced that AFT had signed an exclusive license and supply agreement with Desitin Arzneimittel GmbH (“Desitin”) for Pascomer for the treatment of facial angiofibromas associated with tuberous sclerosis complex (TSC) in Europe. The Company received an upfront milestone payment paid to AFT by Desitin and recorded approximately $
Pursuant to the AFT License Agreement, the Company was obligated to reimburse AFT for previously spent development costs, subject to certain limitations, and to pay a one-time, irrevocable and non-creditable upfront payment to AFT, payable in scheduled installments which was paid in 2020. AFT was entitled to up to $
On April 4, 2022, Nobelpharma America LLC (“Nobelpharma”) announced that the FDA had approved HYFTOR™ (sirolimus topical gel) 0.2% as the first topical treatment indicated for facial angiofibromas associated with tuberous sclerosis complex in adults and children six (6) years of age or older. Nobelpharma’s formulation has orphan drug status for this indication. As Pascomer was intended for treatment of the same indication, the Company determined not to proceed with a pivotal Phase 3 clinical trial of Pascomer in facial angiofibromas at this time, but instead may evaluate potential strategic opportunities for the asset in markets outside of the U.S. and/or other indications.
On July 22, 2022, the Company provided written notice to AFT of its decision to terminate the AFT License Agreement because the Company believed there is no longer a commercially reasonable path to approval and commercialization for TMB-002 in the United States for facial angiofibromas associated with tuberous sclerosis complex. Additionally, following the receipt and analysis of topline data for the Phase II Clinical Trial (as defined in the AFT License Agreement) it was determined that the study failed to meet its primary efficacy endpoint. Under the AFT License Agreement, the Company was required to provide 120 days’ prior written notice of termination to AFT which was waived by AFT on July 25, 2022 (the “Termination Date”). On the Termination Date, the rights and licenses to TMB-002 reverted to AFT, among other things, as set forth in the AFT License Agreement. As the AFT License Agreement has been terminated the Company will no longer receive any royalties or milestones for any transactions under the AFT License Agreement.
Other
The Company disbursed approximately $
Note 4. Accrued Expenses
As of March 31, 2023, and December 31, 2022, the Company’s accrued expenses consisted of the following:
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Research and development | $ | $ | ||||||
| Professional fees | ||||||||
| Personnel expenses | ||||||||
| Accrued interest on Patagonia milestone payable | ||||||||
| Asset Retirement Obligation for former BioPharmX location | ||||||||
| Franchise tax payable | ||||||||
| Other | ||||||||
| Total | $ | $ | ||||||
Note 5. Stockholder’s Equity
The Company entered into a Merger Agreement with BioPharmX and effective May 18, 2020, the Company converted its common and preferred units into shares of common and preferred stock (see Note 1).
2022 Reverse Stock Split
On November 7, 2022, at a special meeting of stockholders (the “Special Meeting”), the holders of a majority of the Company’s outstanding shares of common stock and Series B Mirroring Preferred Stock approved the reverse stock split proposal and gave the Board discretionary authority to select a ratio for the split from 1-for-
On November 7, 2022, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended , with the Secretary of State of Delaware that effected a 1-for-
All shares of common stock, including common stock underlying warrants, stock options, restricted stock units, and VARs, as well as all conversion ratios, exercise prices, conversion prices and per share information in these consolidated financial statements give retroactive effect to the 2022 Reverse Stock Split.
Common Stock
On May 18, 2020, immediately prior to the Merger, the Company filed an amendment to the Certificate of Incorporation with the Secretary of State of the State of Delaware to effect a Reverse Stock Split. As a result of the Reverse Stock Split, the number of issued and outstanding shares of common stock immediately prior to the Reverse Stock Split was reduced into a smaller number of shares, such that every
Under the terms of the Amended Merger Agreement, the Company issued shares of common stock to the holders of common units. The
On May 18, 2020, pursuant to the Merger Agreement (see Note 1),
On May 18, 2020, pursuant to the Merger Agreement,
On November 2, 2021, the Company entered into an underwriting agreement with Wainwright as representative of the several underwriters named in Schedule I thereto, relating to the public offering, issuance and sale of
Wainwright also exercised its over-allotment option, pursuant to the underwriting agreement, to purchase an additional
Series A Warrants
The following is a summary of the Series A Warrants outstanding as of March 31, 2023:
| Weighted | ||||||||||||||||
| Average | ||||||||||||||||
| Shares | Weighted | Remaining | Aggregate | |||||||||||||
| Underlying | Average | Contractual | Intrinsic | |||||||||||||
| Warrants | Exercise Price | Term (Years) | Value | |||||||||||||
| Outstanding as of December 31, 2022 | $ | |||||||||||||||
| Outstanding and exercisable as of March 31, 2023 | $ | $ | ||||||||||||||
Bridge Warrants
The following table summarizes the Company’s Bridge Warrants for the three months ended March 31, 2023:
| Weighted | ||||||||||||||||
| Average | ||||||||||||||||
| Shares | Weighted | Remaining | Aggregate | |||||||||||||
| Underlying | Average | Contractual | Intrinsic | |||||||||||||
| Warrants | Exercise Price | Term (Years) | Value | |||||||||||||
| Outstanding as of December 31, 2022 | $ | $ | ||||||||||||||
| Outstanding and exercisable as of March 31, 2023 | $ | $ | ||||||||||||||
November 2021 Warrants
The warrants issued by the Company were recorded as equity and recognized at fair value which was approximately $
The following table summarizes the Company’s November Warrants for the three months ended March 31, 2023:
| Weighted | ||||||||||||||||
| Average | ||||||||||||||||
| Shares | Weighted | Remaining | Aggregate | |||||||||||||
| Underlying | Average | Contractual | Intrinsic | |||||||||||||
| Warrants | Exercise Price | Term (Years) | Value | |||||||||||||
| Outstanding as of December 31, 2022 | $ | $ | ||||||||||||||
| Outstanding and exercisable as of March 31, 2023 | $ | $ | ||||||||||||||
Redeemable Series A Preferred Stock
In connection with the Merger, on May 18, 2020, the Company filed a Certificate of Designation of Preferences, Rights and Limitations (the “Certificate of Designations”) with the Secretary of State of the State of Delaware that became effective immediately.
Pursuant to the Certificate of Designations, the Company designated
On November 23, 2021, the Company received a request for redemption by TardiMed for the Series A Preferred Stock. The Company asserted that such right to redemption was limited under Delaware corporate law. As a result of the request, the convertible Series A Preferred Stock was reclassified as a liability, Redeemable Series A Preferred Stock under redemption. The previously outstanding shares of Series A Preferred Stock accrued dividends but as a liability and the dividends were recorded prospectively as non-cash interest expense in the Condensed Consolidated Statement of Operations until the Series A Preferred Stock held by TardiMed were redeemed. The Company recognized
On July 27, 2022, the Company, entered into Letter Agreement with TardiMed pursuant to which TardiMed agreed to exchange its
Twenty percent of the TardiMed Warrant was immediately exercisable upon issuance. Beginning on September 30, 2022, and then at the end of each subsequent calendar quarter upon written request of TardiMed, the Company has agreed to allow an additional
Pursuant to the Letter Agreement, TardiMed released and discharged the Company and its affiliates from any and all claims, rights, demands, actions, suits, causes of action, liabilities, obligations, damages and costs of any nature whatsoever that TardiMed has, had or may have against the Company or related parties in any way arising from or related to the Series A Preferred Stock.
The following table summarizes the TardiMed Warrant for the three months ended March 31, 2023:
| Weighted | ||||||||||||||||
| Average | ||||||||||||||||
| Shares | Weighted | Remaining | Aggregate | |||||||||||||
| Underlying | Average | Contractual | Intrinsic | |||||||||||||
| TardiMed Warrant | Exercise Price | Term (Years) | Value | |||||||||||||
| Outstanding as of December 31, 2022 | $ | * | $ | |||||||||||||
| Exercised | ( | ) | $ | * | $ | — | ||||||||||
| Outstanding and exercisable as of March 31, 2023 | $ | * | $ | |||||||||||||
* Options expire once fully exercised; until exercised there is no expiration term
August 2022 Common Stock Warrants
On August 4, 2022, the Company announced the pricing of the public offering (the “August 2022 Offering”) of (i)
The warrants issued by the Company were recorded as equity and recognized at fair value which was approximately $
The following table summarizes the August Warrants for the three months ended March 31, 2023:
| Weighted | ||||||||||||||||
| Average | ||||||||||||||||
| Shares | Weighted | Remaining | Aggregate | |||||||||||||
| Underlying | Average | Contractual | Intrinsic | |||||||||||||
| Warrants | Exercise Price | Term (Years) | Value | |||||||||||||
| Outstanding as of December 31, 2022 | $ | $ | ||||||||||||||
| Outstanding and exercisable as of March 31, 2023 | $ | $ | ||||||||||||||
October 2022 Common Stock Warrants
On October 3, 2022, the Company entered into the October Securities Purchase Agreement (with the “October Investors”) to sell, in the “Registered Offering”) (i)
In the “Concurrent Private Placement Offering” the Company issued (i) Series 2 Warrants to purchase up to an aggregate of
Each share of Series B Preferred Stock has a stated value of $
The Series 2 Warrants are exercisable on the date six (6) months following the date of issuance at an exercise price of $
The following tables summarizes the October Warrants for the three months ended March 31, 2023:
| Weighted | ||||||||||||||||
| Average | ||||||||||||||||
| Shares | Weighted | Remaining | Aggregate | |||||||||||||
| Underlying | Average | Contractual | Intrinsic | |||||||||||||
| Warrants | Exercise Price | Term (Years) | Value | |||||||||||||
| Outstanding and exerciseable as of December 31, 2022 | $ | $ | ||||||||||||||
| Outstanding and exercisable as of March 31, 2023 | $ | $ | ||||||||||||||
Note 6. Equity-based compensation
On May 18, 2020, the Company’s 2020 Omnibus Equity Incentive Plan (the “2020 Plan”) became effective, and the 2020 Plan reserved a total of
Furthermore, the Company maintains its 2019 Equity Incentive Plan (the “2019 Plan”). The 2019 Plan permits the granting of incentive units (the “Incentive Units”), including Value Appreciation Rights ("VARs"). The maximum aggregate Incentive Units that may be subject to awards and issued under the Plan is
During the three months ended March 31, 2023 and 2022, respectively, equity-based compensation expenses were as follows:
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| General and administrative value appreciation right awards | $ | $ | ( | ) | ||||
| General and administrative stock options | ||||||||
| Research and development stock options | ||||||||
| General and administrative restricted stock units | ||||||||
| $ | $ | |||||||
Value Appreciation Rights
In 2019 the Company granted equity-based awards similar to stock options under the 2019 Plan as VARs. The VARs have an exercise price, a vesting period and an expiration date, in addition to other terms similar to typical equity option grant terms.
During the three months ended March 31, 2023, and 2022, respectively, there were
| Weighted | ||||||||||||||||
| Average | ||||||||||||||||
| Weighted | Remaining | |||||||||||||||
| Average | Total Intrinsic | Contractual Life | ||||||||||||||
| Number of Units | Exercise Price | Value | (in years) | |||||||||||||
| Outstanding as of December 31, 2022 | $ | $ | ||||||||||||||
| Outstanding as of March 31, 2023 | $ | $ | ||||||||||||||
| Value appreciation right awards vested and exercisable at March 31, 2023 | $ | $ | ||||||||||||||
As of March 31, 2023, the unrecognized compensation costs were approximately $
Stock Options
The fair value of stock option grants is estimated on the date of grant using the Black-Scholes option-pricing model. The Company was historically a private company and lacked company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies. Additionally, due to an insufficient history with respect to stock option activity and post-vesting cancellations, the expected term assumption for employee grants is based on a permitted simplified method, which is based on the vesting period and contractual term for each tranche of awards. The mid-point between the weighted-average vesting term and the expiration date is used as the expected term under this method. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect for time periods approximately equal to the expected term of the award. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
The following is a summary of the options outstanding as of March 31, 2023:
| Weighted | ||||||||||||||||
| Average | ||||||||||||||||
| Shares | Weighted | Remaining | Aggregate | |||||||||||||
| Underlying | Average | Contractual | Intrinsic | |||||||||||||
| Options | Exercise Price | Term (Years) | Value | |||||||||||||
| Outstanding at December 31, 2022 | $ | $ | ||||||||||||||
| Outstanding at March 31, 2023 | $ | $ | ||||||||||||||
| Exercisable at March 31, 2023 | $ | $ | — | |||||||||||||
As of March 31, 2023, the unrecognized compensation costs related to stock options were approximately $
As part of the Merger, the Company assumed the following legacy stock options and warrants:
| Weighted | ||||||||||||||||
| Shares | Average | |||||||||||||||
| Underlying | Weighted | Remaining | Aggregate | |||||||||||||
| Options and | Average | Contractual | Intrinsic | |||||||||||||
| Warrants | Exercise Price | Term (Years) | Value | |||||||||||||
| Legacy BioPharmX options - December 31, 2022 | $ | $ | — | |||||||||||||
| Legacy BioPharmX options - March 31, 2023 | $ | $ | — | |||||||||||||
| Legacy BioPharmX warrants - December 31, 2022 | $ | $ | — | |||||||||||||
| Legacy BioPharmX warrants - March 31, 2023 | $ | $ | — | |||||||||||||
Restricted Stock Units
The Company issued
| Weighted | ||||||||||||||||
| Shares | Average | |||||||||||||||
| Underlying | Remaining | Aggregate | ||||||||||||||
| Restricted | Grant Date | Contractual | Intrinsic | |||||||||||||
| Stock Units | Fair Value | Term (Years) | Value | |||||||||||||
| Outstanding at December 31, 2022 | $ | $ | ||||||||||||||
| Vested and issued | ( | ) | $ | - | — | |||||||||||
| Unvested at March 31, 2023 | $ | $ | ||||||||||||||
Note 7. Commitments and contingencies
Leases
On February 8, 2023, the Company entered into a lease for a
On March 10, 2021, the Company entered into a lease agreement with SIG 110 LLC with respect to a
In connection with the Merger of BioPharmX, the Company acquired a lease and corresponding sublease for the BioPharmX facility in San Jose, California. The sublease is to be used for general office and research laboratory purposes, has an effective date of February 1, 2020, and has a lease term of
The components of lease expense were as follows:
| Three months ended | Three Months Ended | |||||||
| March 31, 2023 | March 31, 2022 | |||||||
| Operating leases: | ||||||||
| Operating lease cost | $ | $ | ||||||
| Variable lease cost | ||||||||
| Operating lease expense | $ | $ | ||||||
| Lease income - sub lease | ( | ) | ||||||
| Net rent expense | $ | $ | ||||||
Other information:
| Three months ended | Three months ended | |||||||
| March 31, 2023 | March 31, 2022 | |||||||
| Operating cash flows - operating leases | $ | $ | ||||||
| Right-of-use assets obtained in exchange for operating lease liabilities | $ | $ | ||||||
| Weighted-average remaining lease term – operating leases | ||||||||
| Weighted-average discount rate – operating leases | % | % | ||||||
As of March 31, 2023, future minimum payments for the leases are as follows:
| Operating | ||||
| Leases | ||||
| Remaining Months in Year Ending December 31, 2023 | $ | |||
| Year Ended December 31, 2024 | ||||
| Year Ended December 31, 2025 | ||||
| Year Ended December 31, 2026 | ||||
| Year Ended December 31, 2027 | ||||
| Thereafter | ||||
| Total | $ | |||
| Less: present value discount | ( | ) | ||
| Operating lease liabilities | $ | |||
Litigation
The Company is not currently a party to any legal or governmental regulatory proceedings, nor is management aware of any pending or threatened legal or government regulatory proceedings proposed to be initiated against the Company that would have a material adverse effect on the Company’s business, financial condition or operating results.
From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. Periodically, the Company reviews the status of significant matters, if any exist, and assess its potential financial exposure. If the potential loss from any claim or legal claim is considered probable and the amount can be estimated, the Company accrues a liability for the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict; therefore, accruals are based on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation.
Note 8. Related Party Transactions
Patagonia
Patagonia is a private, family-owned company founded in 2013 to address the medical needs of people with rare and serious dermatological conditions. On February 28, 2019, and June 26, 2019, the Company acquired the TMB-001 and TMB-003 licenses from Patagonia (see Note 3 for the payment terms and more details), respectively. The former Chief Operating Officer, Executive Vice-President and Secretary of the Company is also the President of Patagonia. As of March 31, 2023, and December 31, 2022, Patagonia owns
TardiMed
The former Chairman of the Board of the Company is a Managing Member of TardiMed. Our former Chief Operating Officer, Executive Vice President and Secretary is a partner at TardiMed. Our Chief Financial Officer, Treasurer, Secretary, and Executive Vice President of the Company was also a former partner of TardiMed. As of March 31, 2023, TardiMed holds
On March 4, 2022, Mr. Rome stepped down from his positions as Chief Operating Officer and Executive Vice-President of the Company. As a result of his resignation, Mr. Rome (i) was entitled to
Note 9. Subsequent Events
The Company has evaluated its subsequent events from March 31, 2023 through the date these condensed consolidated financial statements were issued and has determined that there are no subsequent events requiring disclosure in these condensed consolidated financial statements other than the items noted below.
TardiMed Warrant Exercise
On April 2, 2023,
Stock Options Granted Pursuant to the 2020 Plan
On April 15, 2023, the Company granted options to purchase an aggregate of
RSUs Granted Pursuant to the 2020 Plan
On April 15, 2023, the Company granted an aggregate of
Item 2. Financial Information.
Management’s Discussion and Analysis of the Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read together with our condensed consolidated financial statements and the related notes and the other financial information included elsewhere in this Quarterly Report and with our audited consolidated financial statements (and notes thereto) for the year ended December 31, 2022 included in our Annual Report on Form 10-K filed with the SEC, particularly those under “Risk Factors.” This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report. We undertake no obligation to update these forward-looking statements to reflect events or circumstances after the date of this report or to reflect actual outcomes.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.
There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:
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our lack of operating history and history of operating losses; |
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our current and future capital requirements and our ability to satisfy our capital needs, including our ability to access financing that may be unavailable due to contractual limitations under the Securities Purchase Agreement (as defined below); |
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our ability to establish or maintain collaborations, licensing or other arrangements for the development and commercialization of our current and future product candidates; |
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our ability to establish sales capabilities through third parties, market and sell our existing or future product candidates, if approved, or generate product revenue; |
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our ability to successfully complete required clinical trials of our products and obtain approval from the U.S. Food and Drug Administration (“FDA”) or other regulatory agents in different jurisdictions; |
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the outcome, costs and timing of clinical trial results for our current or future product candidates; |
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the dilutive effect of our outstanding convertible securities: |
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our ability to maintain or protect the validity of our patents and other intellectual property; |
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the volatility of the price of our common stock, par value $0.001 per share; |
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our ability to retain key executives; |
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our ability to internally develop new inventions and intellectual property; |
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the emergence and effect of competing or complementary products, including the ability of our future products to compete effectively; |
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the accuracy of our estimates regarding expenses and capital requirements |
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our ability to adequately support growth; and |
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the potential impact of outbreaks of communicable diseases, including the COVID-19 pandemic, and adverse global conditions, including political and economic uncertainty on our business, financial conditions, and results of operations, including on our clinical development plans and timelines. |
Trademarks
This Quarterly Report on Form 10-Q includes trademarks, service marks, and trade names owned by us or other companies. All trademarks, service marks, and trade names included in this Quarterly Report on Form 10-Q are the property of their respective owners. Solely for convenience, the trademarks and trade names in this report may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
ADDITIONAL NOTES
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Timber Pharmaceuticals, Inc. and its consolidated subsidiaries are referred to herein as “Timber,” the “Company,” “we,” “us,” and “our,” unless the context indicates otherwise. |
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Amounts and percentages throughout this Quarterly Report on Form 10-Q may reflect rounding adjustments and consequently totals may not appear to sum. |
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All shares of common stock, including common stock underlying warrants, stock options, restricted stock units and VARs, as well as all conversion ratios, exercise prices, conversion prices and per share information in this Quarterly Report on Form 10-Q give retroactive effect to the 2022 Reverse Stock Split (as defined below). |
Overview
Timber Pharmaceuticals, Inc. (“Timber”, the “Company”, “we”, “us”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for orphan dermatologic diseases. Our investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing and control) and safety profiles. We are initially focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (“CI”), including X-linked recessive CI, or XLRI, and autosomal recessive CI, or ARCI and other sclerotic skin diseases. Our lead late-stage program is TMB-001. TMB-003 is our earliest stage program.
TMB-001
TMB-001, a patented topical formulation of isotretinoin using our patented IPEG™ delivery system, completed its Phase 2b clinical trial (the "CONTROL study") in the fourth quarter of 2021, for the treatment of moderate to severe subtypes of CI, a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin. This study demonstrated a clinically meaningful reduction in targeted and overall severity of CI along with a favorable safety profile. The efficacy, pharmacokinetics and safety of TMB-001 is currently being evaluated in a pivotal Phase 3 ASCEND clinical trial (the “Phase 3 ASCEND study”). A prior Phase 1/2 study involving 19 patients with CI demonstrated safety and a signal of preliminary efficacy of TMB-001, as well as minimal systemic absorption.
On October 7, 2021, we announced the completion of our Phase 2b trial in CI. The Phase 2b CONTROL study was a randomized, double-blind, vehicle-controlled study designed to assess the efficacy and safety of two concentrations of TMB-001 (0.05% and 0.1% isotretinoin) for the treatment of two distinct subtypes of moderate-to-severe CI XLRI and autosomal recessive congenital ichthyosis (“ARCI”) in patients (n=33) nine years old or older. Subjects applied TMB-001 twice daily for 12 weeks. The primary endpoint was the reduction of targeted ichthyosis severity, determined by a 50 percent or greater reduction in the validated Visual Index for Ichthyosis Severity (“VIIS”) scaling score (or VIIS-50), a clinically meaningful change. Secondary endpoints included reduction in overall ichthyosis severity, as measured by a two-point improvement using the (IGA) scale, also considered to be a clinically relevant improvement. The study was not designed or powered for statistical analysis of the endpoints and was intended to provide information for future development.
Top-line results including descriptive statistics are described below:
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In the per protocol (the “PP”) population, 100 percent (nominal p= 0.04) and 40 percent (nominal p= ns) of patients treated with TMB-001 0.05% and 0.1%, respectively, achieved VIIS-50 compared to 40 percent in the vehicle group. |
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In the intent to treat (the “ITT”) population, 64 percent (nominal p= 0.17) and 40 percent (nominal p= ns) of patients treated with TMB-001 0.05% and 0.1%, respectively, achieved VIIS-50 compared to 33 percent in the vehicle group. |
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In the PP population, 100 percent (nominal p= 0.002) and 60 percent (nominal p=ns) of patients treated with TMB-001 0.05% and 0.1%, respectively, achieved a ≥2 point improvement in the IGA at week 12 compared to 10 percent in the vehicle group. |
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In the ITT population, 55 percent (nominal p= 0.02) and 40 percent (nominal p=ns) of patients treated with TMB-001 0.05% and 0.1%, respectively, achieved a ≥2 point improvement in the IGA at week 12 compared to 8 percent in the vehicle group. |
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TMB-001 was generally well tolerated with a similar incidence of adverse events ("AEs") across treatment groups. The most frequent AEs were local adverse effects common for such topical treatments. There were no treatment-related serious adverse events ("SAE"). |
On February 3, 2022, we announced the successful completion of an End-of-Phase 2 meeting with the FDA that resulted in a clear path to progress to a pivotal Phase 3 study for TMB-001. The clinical development program for TMB-001 includes a Phase 3 study with an efficacy arm and a maximum use pharmacokinetic arm as well as a smaller bridging study required to bridge to the oral reference product. Based on FDA feedback at the End-of-Phase 2 meeting, we initiated the pivotal Phase 3 ASCEND study of TMB-001 0.05% in the second quarter of 2022. The primary endpoint is the comparison of proportions of subjects with a ≥2 point change from the baseline in IGA-scaling and fissuring scores in the treatment area at 12 weeks between TMB-001 0.05% and vehicle-treated subjects. Key Secondary endpoints include looking at the proportion of patients achieving clear or almost clear skin, and patient reported outcomes (PROs) such as quality of life and itch. On June 23, 2022, we announced that the first four patients had been enrolled in the Phase 3 ASCEND study. We expect to complete enrollment of the Phase 3 ASCEND study in September of 2023 and to report top-line data on the primary endpoint early in the first quarter of 2024. Topline data for the primary efficacy endpoint is expected in the first quarter of 2024 and the complete data set, which will include an additional 12 weeks of maintenance data, is expected to be available at the end of the second quarter of 2024.
In March 2022, a third party presented a late-breaking presentation of a sub-analysis of our Phase 2b CONTROL study that evaluated TMB-001 at the American Academy of Dermatology 2022 Annual Meeting. The sub-type analysis found that TMB-001 0.05% demonstrated a substantially greater proportion of patients achieving VIIS-50 and ≥2-grade IGA improvement compared with vehicle regardless of subtype. Among enrolled patients (TMB-001 0.05% [n=11], 0.1% [n=10], and vehicle [n=12]), 55% had ARCI and 45% XLRI subtypes.
In April 2022, the FDA granted fast track designation to TMB-001 for the treatment of XLRI and ARCI-LI.
In May 2022, the FDA granted breakthrough therapy designation to TMB-001 for the treatment of CI.
In June 2022, the Korean Intellectual Property Office issued a patent covering TMB-001 Korean Patent Number: 10-2406880. Additional patents are pending for TMB-001 in several other countries.
On June 30, 2022, we received a notice of allowance from the United States Patent and Trademark Office for a patent application covering TMB-001 (Application Number: 16/875,710) covering claims to the uses and methods of treating congenital ichthyosis and administering isotretinoin.
In July 2022, we filed a U.S. continuation patent application covering claims to additional subject matter for TMB-001.
In October 2022, the European Commission granted orphan designation for TMB-001 for the treatment of ARCI. The European Medicines Agency (the “EMA”) Pediatric Committee also provided positive comments on the Pediatric Investigation Plan for the treatment of ARCI and XLRI. We plan to respond to the Pediatric Committee and expect a final discussion in the second quarter of 2023, which is a prerequisite for filing a Marketing Authorization Application with the EMA.
In February 2023, the European Commission granted orphan drug designation for TMB-001 for the treatment of XLRI.
In March 2023, a sub-analysis of the Phase 2b CONTROL study was published online in Clinical and Experimental Dermatology (“CED”), the educational journal of the British Association of Dermatologists. The sub-analysis was designed to assess whether the efficacy and safety of TMB-001 differed between subjects with ARCI and XLRI. Results show that treatment with TMB-001 demonstrated greater proportions of participants achieving the primary and key secondary endpoints versus vehicle regardless of the subtype of CI.
TMB-003
The earliest stage product in our pipeline is TMB-003, a proprietary formulation of Sitaxsentan, a new chemical entity in the U.S., which is a selective endothelin-A receptor antagonist. It is currently in preclinical development as a locally applied formulation for the treatment of sclerotic skin diseases. The two disease areas under consideration include Lichen Sclerosis a rare chronic disease of vulvae and perianal areas, and Localized Scleroderma, a chromic connective tissue disease that also affects other organ systems.
On January 12, 2021, we announced that the FDA has granted orphan drug designation for TMB-003, our locally delivered formulation of Sitaxsentan, for the treatment of Systemic Sclerosis. We are considering pursuing additional orphan drug designations in other indications in the future.
BPX-01 and BPX-04
In connection with the merger with BioPharmX Corporation (“BioPharmX”) on May 18, 2020, we acquired the BPX-01 and BPX-04 assets. BPX-01 is a Phase 3 ready topical minocycline for the treatment of inflammatory lesions of acne vulgaris. BPX-04 is a Phase 3 ready topical minocycline for the treatment of papulopustular rosacea. On September 15, 2020, we announced that we had received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for a Company patent application covering BPX-01 and BPX-04 (U.S. Patent Application No.: 16/514,459) and the application subsequently issued on January 5, 2021, as U.S. 10,881,672. We are seeking to monetize these assets through a license, co-development, or sale.
Merger with BioPharmX Corporation
On May 18, 2020, we completed our business combination with BioPharmX in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of January 28, 2020 by and among BioPharmX, Timber Pharmaceuticals, LLC, a Delaware limited liability company (“Timber Sub”) and BITI Merger, Inc., a Delaware corporation and wholly-owned subsidiary of BioPharmX (“Merger Sub”), as amended on March 24, 2020 (and as subsequently amended on April 27, 2020 as amended, the “Merger Agreement”), pursuant to which Merger Sub merged with and into Timber Sub, with Timber Sub surviving as our wholly-owned subsidiary (the “Merger”). In connection with the Merger, BioPharmX effected a reverse stock split of the shares of common stock, at a ratio of 1-for-12 (the “2020 Reverse Stock Split”). Following the completion of the Merger, we changed our name to “Timber Pharmaceuticals, Inc.” and the officers and directors of Timber Sub became the officers and directors of our Company.
In connection with the Merger, the 11.68 VARs of Timber Sub that were outstanding immediately prior to Merger became denoted and payable in 7,353 shares of common stock at the effective time of the Merger (the “Effective Time”). Further, the holder of the 1,819,289 preferred units of Timber Sub outstanding immediately prior to the Merger received 1,819 shares of the Series A preferred stock (the “Series A Preferred Stock”) at the Effective Time.
In connection with the Merger Agreement, on March 27, 2020, Timber Sub and BioPharmX entered into a securities purchase agreement (the “Securities Purchase Agreement”), with certain accredited investors (the “Investors”) pursuant to which Timber Sub issued to the Investors shares of Timber units immediately prior to the Merger and we issued to the Investors warrants to purchase shares of common stock on the tenth trading day following the consummation of the Merger (the “Investor Warrants”) in a private placement transaction for an aggregate purchase price of approximately $25 million . We issued to the Investors 167,695 Series A Warrants to purchase shares of common stock (“Series A Warrants”) and 140,844 Series B Warrants to purchase shares of common stock (“Series B Warrants”). The Series A Warrants have a 5-year term and an exercise price of $2.7953, subject to the number of shares and exercise price being reset based on our stock price after the Merger. The Series A Warrants were initially exercisable into 167,695 shares of common stock, subject to certain adjustments. The Series B Warrants had an exercise price per share of $0.05, were exercisable upon issuance and were initially convertible into 140,844 shares of common stock in the aggregate.
In addition, pursuant to the terms of the Securities Purchase Agreement, on May 22, 2020 we issued to the Investors warrants to purchase 8,275 shares of common stock (the “Bridge Warrants”) which had an exercise price of $111.81 per share, which was revised to $15.50 per share as a result of the November 2021 Offering (as defined below), and subsequently revised to $1.00 per share as a result of the August 2022 Offering (as defined below).
On July 17, 2020, we entered into an Amended and Restated Registration Rights Agreement (as amended, the “Registration Rights Agreement”) with the Investors. Pursuant to the Registration Rights Agreement, we agreed to provide certain demand registration rights to the Investors relating to the registration of the shares underlying the Investor Warrants and the Bridge Warrants. In connection with the entry into the Registration Rights Agreement and pursuant to the Securities Purchase Agreement, we were restricted from various financing activities until August 16, 2022.
On November 19, 2020, we entered into a Warrant Waiver Agreement with each of the warrant holders of the Series A Warrants and Series B Warrants (the "Warrant Waiver Agreement") which modified the terms of the original agreement and eliminated further resets. The aggregate number of Series A Warrants issued was fixed at 403,564 and the warrant exercise price was fixed at $58.00. The aggregate number of Series B Warrants was fixed at 455,336. The exercise price of the Series B Warrants remained unchanged.
In addition, certain restrictions contained in the Warrant Waiver Agreement and Securities Purchase Agreement were modified including restrictions on our ability to issue additional equity securities in connection with a financing and our ability to complete a fundamental transaction. Subject to certain restrictions detailed in the Warrant Waiver Agreement, we are now able to complete an equity financing or a fundamental transaction at any time after April 30, 2021. However, we remain restricted with respect to conducting variable rate transactions until May 18, 2023.
Further, in connection with the Warrant Waiver Agreement we agreed to immediately register 227,628 shares of common stock issuable upon exercise of the Series B Warrants. The warrant holders have additional demand registration rights as described in the Warrant Waiver Agreement. As of March 4, 2021, the Series B Warrants were exercised in full. As of March 31, 2023, 334,036 shares of common stock remain issuable upon exercise of the Series A Warrants.
Material Agreements
Asset Purchase Agreements with Patagonia Pharmaceuticals LLC (“Patagonia”)
TMB-001
On February 28, 2019, we acquired the intellectual property rights for a topical formulation of isotretinoin for the treatment of CI and identified as TMB-001, formerly PAT-001 including the IPEGTM brand, from Patagonia (the “TMB-001 Acquisition”) pursuant to an asset acquisition agreement (the “Asset Acquisition Agreement”). Zachary Rome a former member of our Board and our former Executive Vice-President and Chief Operating Officer serves as President of Patagonia and also maintains an ownership interest therein.
Under the terms of the TMB-001 Acquisition, we paid a one-time upfront payment of $50,000 to Patagonia. Patagonia is entitled to up to $27.0 million of cash milestone payments relating to certain regulatory and commercial achievements of the TMB-001 Acquisition, with the first being $4.0 million from the initiation of a Phase 3 pivotal trial, as agreed with the FDA and defined as the first patient enrolled in such trial for the product. The next milestone payments relate to (i) a one-time payment of $7.0 million upon FDA approval of an NDA related to the product for the treatment of CI, or a substantially similar indication, and (ii) a one-time payment of $2.0 million upon EMA approval of an MMA related to the product for the treatment of CI, or a substantially similar indication. In addition, Patagonia is entitled to net sales earn-out payments ranging from low single digits to mid-double digits for the program licensed. We are responsible for all development activities under the agreement. The first regulatory and commercial milestone occurred in June 2022, as the first patient enrolled in the Phase 3 pivotal trial for the product and as such a $4.0 million milestone payment was accrued at June 30, 2022. There were no further milestone payments accrued at March 31, 2022 and December 31, 2022, respectively, because the potential regulatory and commercial milestones were not considered probable.
On July 20, 2022, we entered into the Amendment to the Asset Acquisition Agreement with Patagonia, pursuant to which we and Patagonia extended the time for our payment of the first milestone payment, which became payable in the third quarter of 2022 upon the commencement of patient enrollment in our Phase 3 ASCEND clinical trial in the second quarter of 2022. The first milestone payment became payable by us in two tranches, with $2.25 million due by September 1, 2022, and $2.065 million due by September 1, 2023. The first milestone payment was made on September 1, 2022. We are accreting interest on the second tranche. The interest is recorded in our Consolidated Statement of Operations and Comprehensive Loss. In addition to the remedies for breach under the Asset Acquisition Agreement, including reversion under certain circumstances, we granted Patagonia a security interest in TMB-001 and certain other assets until the second milestone payment has been paid in full. Because the milestone payments due upon the achievement of certain events would be payable prior to the time in which we are able to generate revenue, such obligations under the Asset Acquisition Agreement, as amended, may impact the economic viability of developing and marketing TMB-001.
TMB-003
On June 26, 2019, we acquired the intellectual property rights for a locally administered formulation of Sitaxsentan for the treatment of cutaneous fibrosis and/or pigmentation disorders, and identified as TMB-003, formerly PAT-S03, from Patagonia (the “TMB-003 Acquisition”).
Upon closing of the TMB-003 Acquisition, we paid a one-time upfront payment of $20,000 to Patagonia. Patagonia is entitled to up to $10.25 million of cash milestone payments subject to adjustments relating to certain regulatory and commercial achievements of TMB-003, with the first being a one-time payment of $250,000 upon the opening of investigational new drug application (“IND”) with the FDA. In addition, Patagonia is entitled to net sales earn-out payments ranging from low to mid-single digits for the program licensed. We are responsible for all development activities under the license. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at March 31, 2023, and December 31, 2022, respectively.
Acquisition and Termination of License from AFT Pharmaceuticals Limited (“AFT”)
On July 5, 2019, we entered into a license agreement with AFT which provided us with (i) an exclusive license to certain licensed patents, licensed know-how and AFT trademarks to commercialize a proprietary topical formulation of rapamycin marketed under the brand name Pascomer (“Pascomer”) in the United States, Canada and Mexico and (ii) a co-exclusive license to develop Pascomer in this territory. Concurrently, we granted to AFT an exclusive license to commercialize Pascomer outside of its territory and co-exclusive sublicense to develop and manufacture the licensed product for commercialization outside of its territory (the “AFT License Agreement”).
On July 22, 2022, we provided written notice to AFT of our decision to terminate the AFT License Agreement because we believed there was no longer a commercially reasonable path to approval and commercialization for the Pascomer product in the United States. Additionally, following the receipt and analysis of topline data for the Phase II Clinical Trial (as defined in the AFT License Agreement) it was determined that the study failed to meet its primary efficacy endpoint. Under the AFT License Agreement, we were required to provide 120 days’ prior written notice of termination to AFT which was waived by AFT on July 25, 2022 (the “Termination Date”). On the Termination Date, the rights and licenses to Pascomer reverted to AFT, among other things, as set forth in the AFT License Agreement.
Letter Agreement with TardiMed Sciences LLC (“TardiMed”)
We previously had shares of Series A Preferred Stock outstanding as to which the holder, TardiMed, had demanded redemption. Michael Derby, our former Chief Executive Officer and former Chairman of our Board is the Managing Member of TardiMed. The redemption price was equal to approximately $2.1 million in the aggregate, at December 31, 2021, including accumulated and unpaid dividends which accrue at the rate of 8% per annum. Redemption was subject to certain limitations under Delaware corporate law due to our financial condition. As a result of the call for redemption, the Series A Preferred Stock had been reclassified as a liability at December 31, 2021. Dividends continued to accrue and were recorded as non-cash interest expense in the Statement of Operations and Comprehensive Loss rather than to additional-paid-in-capital in 2022.
On July 27, 2022, we entered into a letter agreement with TardiMed (the “Letter Agreement”) pursuant to which TardiMed agreed to exchange its 1,819 shares of Series A Preferred Stock plus accrued dividends for a pre-funded warrant to purchase 181,083 shares of common stock (the “TardiMed Warrant”). The number of shares underlying the TardiMed Warrant was based on the redemption price of the Series A Preferred Stock (which had been demanded by TardiMed) divided by $11.95, the last closing price of the common stock prior to the date the Letter Agreement was executed.
Twenty percent of the TardiMed Warrant was immediately exercisable upon issuance. Beginning on September 30, 2022, and then at the end of each subsequent calendar quarter upon written request of TardiMed, we have agreed to allow an additional 20% of the initial balance of the TardiMed Warrant to become exercisable, provided that only 20% of the initial balance of the TardiMed Warrant will be exercisable in any given quarter. The TardiMed Warrant’s exercise price is $0.005 and may be exercised on a cashless basis. The TardiMed Warrant will terminate when exercised in full. As of March 31, 2023, 60% of the TardiMed Warrant has been exercised on a cashless basis and an aggregate of 108,476 shares of common stock have been issued to TardiMed.
Sublease Agreement
We currently lease an 11,793 square foot office and laboratory space at 115 Nicholson Lane, San Jose, California. This lease expires in December 2023. On February 17, 2020, we executed a sublease agreement covering the entire space for the remaining term of the lease. The current monthly rent at this location is $37,710, which includes common area maintenance charges. The sublessee unexpectedly ceased making sublease payments in the fourth quarter of 2022 due substantial financial difficulties. We have been working with the owner of the property to market the location. The sublessee has been found to have made multiple alterations to the location without permits or the lessor’s approval and we have received an estimate for repairs to the existing space and costs to clean the location that will approximate $150,000. This amount is recorded in accrued expenses at March 31, 2023 and at December 31, 2022, respectively, as an asset retirement obligation.
Offerings
August 2022 Offering
On March 1, 2022, we entered into an engagement agreement, as subsequently amended on June 30, 2022 (the “Engagement Agreement”), with H.C. Wainwright & Co., LLC ("Wainwright"), pursuant to which Wainwright agreed to act as the exclusive placement agent on a reasonable best efforts basis in connection with a public offering of common stock.
On August 4, 2022, we announced the pricing of the public offering (the “August 2022 Offering”) of (i) 931,667 shares of common stock, (ii) pre-funded warrants to purchase up to an aggregate of 401,667 shares of common stock and (iii) common warrants to purchase up to an aggregate of 1,333,333 shares of common stock (the “August Warrants”). Each share of common stock and pre-funded warrant to purchase one share of common stock was sold together with an August Warrant to purchase one share of common stock. All of the securities sold in the August 2022 Offering were sold by us. The public offering price of each share of common stock and accompanying August Warrant was $6.00 and $5.995 for each pre-funded warrant and accompanying August Warrant. The pre-funded warrants were immediately exercisable at a price of $0.005 per share of common stock and were exercisable at any time until all of the pre-funded warrants were exercised in full. The August Warrants are immediately exercisable at a price of $6.00 per share of common stock and will expire five years from the date of issuance. The shares of common stock and pre-funded warrants, and the accompanying August Warrants, were issued separately and were immediately separable upon issuance. The August 2022 Offering closed on August 8, 2022. All of the pre-funded Warrants were exercised.
In connection with the August 2022 Offering, on August 4, 2022, we entered into securities purchase agreements (the “August Purchase Agreements”) with certain institutional investors in the August 2022 Offering. The net proceeds to us from the August 2022 Offering were approximately $6.9 million, after deducting placement agent fees and expenses and estimated offering expenses payable by us, excluding the proceeds, if any, from the exercise of the August Warrants. We intend to use the net proceeds from the August 2022 Offering for research and development, including clinical trials, working capital and general corporate purposes. As of March 31, 2023 and December 31, 2022, respectively, 1,309,333 shares of common stock remain issuable upon the exercise of the August Warrants.
October 2022 Offering
On October 3, 2022, we entered into a Securities Purchase Agreement (the “October Purchase Agreement”) with several institutional accredited investors (the “October Investors”) to sell, in a registered direct offering (the “Registered Offering”) (i) 260,000 shares of common stock, and (ii) Series 1 common warrants (the “Series 1 Warrants”) to purchase up to an aggregate of 260,000 shares of common stock (the “Series 1 Warrant Shares”). The Series 1 Warrants are immediately exercisable at an exercise price of $5.00 per share and will expire two and one-half years following the initial exercise date. The October Purchase Agreement contains customary representations and warranties and agreements of us and the October Investors, and customary indemnification rights and obligations of the parties. Total gross proceeds from the Registered Offering, before deducting the placement agent’s fees and other estimated offering expenses, was $1.3 million. The Registered Offering closed on October 3, 2022.
In a concurrent private placement (the “Concurrent Private Placement Offering” and, together with the Registered Offering, the “October 2022 Offerings”) we also agreed to issue (i) Series 2 common warrants (the “Series 2 Warrants”) to purchase up to an aggregate of 260,000 shares of underlying common stock (the “Series 2 Warrant Shares”), and (ii) 13,000 shares of Series B Mirroring Preferred Stock (the “Series B Preferred Stock”).
Each share of Series B Preferred Stock had a stated value of $0.001 per share. The Series B Preferred Stock had super voting rights on the approval of the 2022 Reverse Stock Split (as defined below) equal to 10,000,000 votes per share of Series B Preferred Stock. The voting rights of the Series B Preferred Stock were established in order to maintain our NYSE American listing by raising the average minimum bid price of the common stock to over $0.20 for 30 consecutive trading days. Upon the effectiveness of the Certificate of Amendment (as defined below), the outstanding shares of Series B Preferred Stock were automatically transferred to us and cancelled for no consideration with no action on behalf of the holders thereof and such shares resumed the status of authorized but unissued shares of preferred stock and were no longer designated as shares of Series B Stock.
The Series 2 Warrants are exercisable on the date six (6) months following the date of issuance at an exercise price of $6.00 per share and will expire two and one-half years following the initial exercise date. The Series B Preferred Stock was not, and the Series 2 Warrants and Series 2 Warrant Shares issuable upon exercise of the Series 2 Warrants have not been, registered under the Securities Act of 1933, as amended (the “Securities Act”), and were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.
As compensation to Wainwright, as the exclusive placement agent in connection with the Registered Offering, we paid Wainwright a cash fee of 6% of the aggregate gross proceeds raised in the Registered Offering and reimbursed Wainwright for legal fees and expenses up to $40,000, non-accountable expenses of $25,000 and $15,950 for clearing expenses. In connection with the October 2022 Offerings, we received net proceeds of approximately $1.0 million. As of March 31, 2023, none of the Series 1 Warrants or Series 2 Warrants have been exercised.
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Reverse Stock Split
On November 8, 2022, we filed a Certificate of Amendment to the Company’s Certificate of Incorporation, as amended (the “Certificate of Amendment”), with the Secretary of State of the State of Delaware, which effected, at 5:00 p.m. Eastern Time on November 8, 2022, the 2022 Reverse Stock Split of the Company’s issued and outstanding shares of common stock at a ratio of one-for-fifty (the “2022 Reverse Stock Split”). All per share amounts and number of shares of common stock in this Current Report on Form 10-Q reflect the 2022 Reverse Stock Split. The 2022 Reverse Stock Split did not affect our authorized preferred stock of 450,000,000 shares. Proportionate adjustments were made to the conversion rate, the per share exercise price and the number of shares issuable upon the vesting, exercise or conversion of the Company’s outstanding derivative securities in accordance with the 2022 Reverse Stock Split ratio.
As a result of the 2022 Reverse Stock Split, every fifty shares of common stock issued and outstanding was converted into one share of common stock. The 2022 Reverse Stock Split affected all stockholders uniformly and did not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the 2022 Reverse Stock Split would have resulted in some stockholders owning a fractional share. No fractional shares were issued in connection with the 2022 Reverse Stock Split. Stockholders who would otherwise have been entitled to a fractional share of common stock were instead entitled to receive a proportional cash payment. The common stock began trading on a post-split as-adjusted basis on November 9, 2022. There can be no assurance that we will be able to regain or maintain compliance with the NYSE American continued listing standards, even after the implementation of the 2022 Reverse Stock Split.
Corporate History
We have a limited operating history as the Company was formed on February 26, 2019. Since inception, our operations have focused on establishing its intellectual property portfolio, including acquiring rights to the proprietary formulations of isotretinoin, rapamycin and Sitaxsentan, as described above, organizing and staffing the Company, business planning, raising capital, and conducting clinical trials. We have financed our operations in the last three years with gross proceeds totaling approximately $51.6 million through capital contributions and bridge loan.
We have incurred significant operating losses since inception. For the three months ended March 31, 2023, our net loss was approximately $4.1 million. As of March 31, 2023, we had an accumulated deficit of approximately $52.3 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we continue to develop the pipeline of programs.
Results of Operations
Comparison of the Three Months Ended March 31, 2023, and 2022
| Three Months Ended March 31, |
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| 2023 |
2022 |
Change $ |
Change % |
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| Grant revenue |
$ | — | $ | 83,177 | $ | (83,177 | ) | (100 | )% |
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| Research and development |
2,365,751 | 1,518,959 | 846,792 | 56 | % |
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| Selling, general and administrative |
1,634,679 | 1,702,395 | (67,716 | ) | (4 | )% |
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| Loss from operations |
(4,000,430 | ) | (3,138,177 | ) | (862,253 | ) | 27 | % |
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| Interest expense |
(62,977 | ) | (54,252 | ) | (8,726 | ) | 16 | % |
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| Other income |
— | 75,000 | (75,000 | ) | NA | % |
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| Forgiveness of PPP loan |
— | 37,772 | (37,772 | ) | NA | % |
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| Gain on foreign currency exchange |
2,155 | 6,262 | (4,107 | ) | (66 | )% |
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| Net loss and comprehensive loss |
(4,061,252 | ) | (3,073,394 | ) | (987,858 | ) | 32 | % |
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| Net loss attributable to common stockholders |
$ | (4,061,252 | ) | $ | (3,073,394 | ) | $ | (987,858 | ) | 32 | % |
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Grant and Milestone Revenue
In September 2018, Patagonia was awarded a $1.5 million grant (the “Grant”) from the FDA as part of the Orphan Products Clinical Trials Grants Program of the Office of Orphan Products Development. The Grant funds were made available in three annual installments of $500,000 per year, which commenced in September 2018. The Grant was transferred to us pursuant to the TMB-001 Acquisition Agreement with Patagonia in February 2019. In March 2020 and March 2021, the FDA awarded us the second and third tranches of the grant, respectively.
During the three months ended March 31, 2023, and 2022, we recognized no revenues and revenue of approximately $0.1 million respectively, from the Grant.
Operating Costs and Expenses
Research and Development Expense
During the three months ended March 31, 2023, and 2022, research and development expenses were approximately $2.4 and $1.5 million, respectively. The increase in research and development expenses of approximately $.9 million is primarily related to $0.8 million of increased expenses associated with the Phase 3 clinical trial of TMB-001 such as CRO direct and pass-through expenses and $0.1 million of increased payroll costs as two additional research and development personnel were added after the first quarter of 2022. Research and development expenses are expected to continue to increase in 2023 as a result of the Phase 3 ASCEND study for TMB-001.
Research and development costs are expensed as incurred. Costs for certain activities, such as preclinical studies and clinical trials, are generally recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and collaborators.
General and Administrative Expense
For the three months ended March 31, 2023, general and administrative expenses were approximately $1.6 million compared to $1.7 million for the three months ended March 31, 2022. General and administrative expenses decreased approximately $0.1 million due to an approximately $0.2 million reduction in stock compensation expense due the acceleration of stock options vesting that occurred in March 2022 for our former Chief Operating Officer, a reduction in legal fees of approximately $0.1 million in the first quarter of 2023 compared to the first quarter of 2022, offset by an increase in lease expense of $0.1 million in the first quarter of 2023 due to the default of our sublessee at the former BioPharmX location in California and an increase in market research expense of approximately $0.1 million in the first quarter of 2023 which did not occur in the first quarter of 2022.
Other Income (Expense)
For the three months ended March 31, 2023, other income (expense) of approximately $0.06 million included interest expense of approximately $0.06 million related to the milestone payable due to Patagonia Pharmaceuticals LLC for the accretion for the second tranche of the Patagonia milestone payment. For the three months ended March 31, 2022, other income (expense) of approximately $0.07 million was comprised of interest expense of $0.05 million for interest for the Redeemable Series A Preferred Stock under redemption, a gain on the forgiveness of our PPP loan of approximately $0.04 million and other income of approximately $0.08 million for fees received from a third party for their access to review certain agreements related to BPX-01 and BPX-04.
Income Taxes
We did not record any tax expense for the three-months ended March 31, 2023 and 2022, respectively, due to our loss position and full valuation allowance.
Liquidity and Capital Resources
Since inception, we have not generated revenue from product sales and have incurred net losses and negative cash flows from our operations. At March 31, 2023, we had working capital of approximately $0.8 million, which included cash of approximately $5.2 million. We reported a net loss of approximately $4.1 million during the three months ended March 31, 2023.
Cash Flows for the Three Months Ended March 31, 2023 and 2022
| Three Months Ended March 31, |
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| 2023 |
2022 |
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| Cash provided by (used in) continuing operations: |
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| Operating activities |
$ | (3,902,981 | ) | $ | (2,944,747 | ) | ||
| Investing activities |
(1,961 | ) | (3,519 | ) | ||||
| Financing activities |
— | — | ||||||
| Net decrease in cash and cash equivalents |
$ | (3,904,942 | ) | $ | (2,948,266 | ) | ||
Operating Activities
For the three months ended March 31, 2023, net cash used in operating activities was approximately $3.9 million, which primarily consisted of our net loss of approximately $4.1 million, adjusted for non-cash expenses of approximately $0.1 million of stock-based compensation expense, amortization of our right of use assets of approximately $0.1 million, offset by the change in assets and liabilities of approximately $0.06 million, which is primarily due an decrease in prepaid expenses of approximately $0.3 million related to research and development, and an decrease in accounts payable and accrued expenses of approximately $0.4 million due to timing of payments related to research and development expenses.
For the three months ended March 31 2022, net cash used in operating activities was $2.9 million, which primarily consisted of our net loss of approximately $3.1 million, adjusted for non-cash expenses of approximately $0.4 million of stock-based compensation expense offset by the change in assets and liabilities of $0.3 million, which is primarily due an decrease in accounts payable of $0.1 million and a decrease in accrued expenses of $0.2 million and a decrease in the lease liability of $0.1 million
Investing Activities
For the three months ended March 31, 2023, and 2022, net cash used in investing activities was for purchases of laptops for employees, respectively.
Financing Activities
For the three months ended March 31, 2023, and 2022, there was no cash provided by financing activities.
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of our pipeline of programs. Our expenses related to clinical trials are expected to increase in 2023. Furthermore, we expect to continue to incur costs as a public company and as a result of our obligations under existing agreements with third parties. Accordingly, we will need to obtain additional funding. In addition, we remain restricted with respect to conduction variable rate transactions until May 18, 2023 pursuant to the terms of the Registration Rights Agreement. If we are unable to raise capital or otherwise obtain funding when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.
We expect that our research and development expenses in connection with our development programs for our various product candidates will continue to be significant. As a result, we expect to continue to incur significant and increasing operating losses and negative cash flows for the foreseeable future.
We have evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year beyond the filing of this Quarterly Report on Form 10-Q. Based on such evaluation and our current plans, which are subject to change, management believes that our existing cash and cash equivalents as of March 31, 2023 only are sufficient to satisfy our operating cash needs into the second quarter of 2023.
Our future liquidity and capital funding requirements will depend on numerous factors, including:
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our ability to raise additional funds to finance our operations, |
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the outcome, costs and timing of clinical trial results for our current or future product candidates, including the timing, progress, costs and results of our Phase 3 ASCEND study of TMB-001 for the treatment of CI; |
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the outcome, timing and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities; |
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the emergence and effect of competing or complementary products including the ability of our future products to compete effectively; |
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our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; |
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the cost and timing of completion of commercial-scale manufacturing activities if any of our products are approved for commercial sale; |
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the cost of establishing sales, marketing and distribution capabilities for our products in regions where we choose to commercialize our products on our own if approved for commercial sale; |
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the initiation, progress, timing and results of the commercialization of our product candidates, if approved for commercial sale; |
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our ability to retain our current employees and the need and ability to hire additional management and scientific and medical personnel; and |
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the terms and timing of any collaborative, licensing or other arrangements that we have or may establish. |
We will need to raise substantial additional funds through one or more of the following: issuance of additional debt or equity and/or the completion of a licensing or other commercial transaction for one or more of our product candidates. Further, we intend to continue to evaluate options for our strategic direction. We are exploring ways to efficiently fund the Company including entering into non-dilutive partnerships or licensing agreements. If we are unable to maintain sufficient financial resources, our business, financial condition and results of operations will be materially and adversely affected. This could affect future development and business activities and potential future clinical studies and/or other future ventures. There can be no assurance that we will be able to obtain the needed financing on acceptable terms or at all. Additionally, equity or convertible debt financings will likely have a dilutive effect on the holdings of our existing stockholders.
Critical Accounting Policies and Significant Estimates
Our management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financials statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the revenue and expenses incurred during the reporting periods. On an ongoing basis, we evaluate our estimates and adjustments, including those related to research and development, accrued expenses and share-based compensation. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ from these estimates under different assumptions or conditions.
The Company accounts for stock-based compensation in accordance with ASC 718, “Compensation—Stock Compensation,” which requires the measurement and recognition of compensation expense based on estimated fair market values for all share-based awards made to employees and directors, including stock options. The Company expenses stock-based compensation to employees, non-employees and board members over the requisite service period based on the estimated grant-date fair value of the awards and actual forfeitures. The Company accounts for forfeitures as they occur. Stock-based awards with graded-vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award.
There have been no material changes to our critical accounting policies and estimates as compared to the critical accounting policies and estimates described in our latest Annual Report on Form 10-K.
Recently Used and Adopted Accounting Pronouncements
See Note 2 to our financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for discussion of recent accounting pronouncements.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
Not applicable.
Item 4. Controls and Procedures.
Disclosure Controls and Procedures
The Company maintains disclosure controls and procedures (as defined in Rule 13a-15 (e) or 15d-15(e) of the Exchange Act) that are designed to ensure that information required to be disclosed in periodic reports filed with the SEC under the Securities Exchange Act of 1934 is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Under the supervision and with the participation of our management, including the Chief Executive Officer and Chief Financial Officer, we have evaluated the effectiveness of our disclosure controls and procedures as defined in Rule 13(a)-15(e) under the Exchange Act as of the end of the period covered by this report. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of March 31, 2023.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal periods ended March 31, 2023, which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
We are not currently a party to any legal or governmental regulatory proceedings, nor is our management aware of any pending or threatened legal or government regulatory proceedings proposed to be initiated against us that would have a material adverse effect on our business, financial condition or operating results.
From time to time, we could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. Periodically, we review the status of significant matters, if any exist, and assess our potential financial exposure. If the potential loss from any claim or legal claim is considered probable and the amount can be estimated, we accrue a liability for the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict; therefore, accruals are based on the best information available at the time. As additional information becomes available, we reassess the potential liability related to pending claims and litigation. .
As a smaller reporting company, we are not required to provide the information required by this item.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
We have not furnished information under this item to the extent that such information previously has been included under Item 3.02 in a Current Report on Form 8-K.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosure.
Not applicable.
None.
| 32.2** |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
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| 101.SCH* |
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Inline XBRL Taxonomy Extension Schema Document. |
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| 101.CAL* |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
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| 101.DEF* |
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Inline XBRL Taxonomy Extension Definition Linkbase Document. |
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| 101.LAB* |
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Inline XBRL Taxonomy Extension Label Linkbase Document. |
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| 101.PRE* |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
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| 104 |
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Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibits 101). |
*Filed herewith.
**The certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the registrant specifically incorporates it by reference.
#All schedules and exhibits to the agreement have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the Securities and Exchange Commission upon request.
Pursuant to the requirements of the Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Timber Pharmaceuticals, Inc. |
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| Date: May 15, 2023 |
By: |
/s/ John Koconis |
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John Koconis |
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Chief Executive Officer and Chairman of the Board of Directors |
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(Principal Executive Officer) |
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| Date: May 15, 2023 |
By: |
/s/ Joseph Lucchese |
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Joseph Lucchese |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |