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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): November 22, 2021

 

TIMBER PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-37411   59-3843182
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

110 Allen Road, Suite 401

Basking Ridge, NJ 07920

(Address of principal executive offices)

Registrant’s telephone number, including area code: (908)636-7160

 

N/A

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

  

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, $0.001 Par Value   TMBR   The NYSE American, LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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. ¨

 

 

 

     

 

 

Item 7.01 Regulation FD Disclosure.

 

Timber Pharmaceuticals, Inc. has prepared presentation materials (the “Investor Presentation”) that management intends to use with its conference call to be held at 10 A.M. (EST) on November 22, 2021. A copy of the Investor Presentation is attached as Exhibit 99.1 hereto.

 

The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as shall be expressly set forth by a specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Exhibit
     
99.1   Investor Presentation
104   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

  

  2  

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Timber Pharmaceuticals, Inc.
   
Date: November 22, 2021 By: /s/ John Koconis
  Name:  John Koconis
  Title:  Chief Executive Officer

 

  3  

 

 

Exhibit 99.1

 

Building Bridges in Medical Dermatology TMB - 001 Phase 2b CONTROL Study Results Conference Call November 22, 2021 NYSE American: TMBR

 

NYSE American: TMBR Safe Harbor Statement 2 Certain statements contained in this PowerPoint presentation describing Timber’s technology and development program, including, without limitation, statements containing the words “expects,” “anticipates,” “believes,” and words of similar import, constitute “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 . These forward - looking statements are subject to various risks and uncertainties that could cause actual future results and events to differ materially from those currently anticipated, including risks discussed in Timber’s Form 10 - K for the year ended December 31 , 2020 and any subsequent filings with the Securities and Exchange Commission . Potential investors are cautioned not to place undue reliance on these forward - looking statements .

 

NYSE American: TMBR Strategic Pipeline in Rare Dermatologic Disease 3

 

NYSE American: TMBR Unmet Need: An efficacious and safe treatment that can be used long term to cover a large body surface area . 4 TMB - 001 for Congenital Ichthyosis A rare disorder of keratinization affecting ~ 80,000 people in the U.S. (>1.5 million globally)  Prevalence • X - Linked Ichthyosis has a prevalence of 1:2,000 - 1:6,000 males • Lamellar Ichthyosis has a prevalence of 1:100,000 - 200,000  Quality of life is significantly affected • Skin inflammation and fragility, pruritus, fissuring and cracking of thickened skin, ectropion, anhidrosis, and in some severe cases, an increased susceptibility to infection • In Lamellar Ichthyosis, almost the whole body can be covered and be severe • Increased rates of depression, anxiety and decreased quality of life on multiple validated clinical measures  No FDA Approved treatments 2017 Yale Copyright 2017 Yale Copyright 2017 Yale Copyright

 

NYSE American: TMBR 5 TMB - 001 Topical Isotretinoin in CI Patented topical formulation minimizing systemic absorption and allowing for chronic treatment  Isotretinoin is well known as the most effective therapy for several skin conditions, including ichthyosis, but it is only available orally, where high dose, chronic oral therapy cannot be tolerated due to systemic toxicity  TMB - 001 utilizes patented IPEG  delivery system to target isotretinoin delivery to the epidermis and dermis, minimize systemic absorption and remove irritating excipients  Development Stage: • Phase 2B CONTROL study in CI is complete; topline data was presented in Q4 2021 • Phase Ib/2a POC study in CI completed in 2018 with positive data on clinically meaningful safety and efficacy endpoints and no significant systemic absorption  2018 FDA Orphan Products Grant Recipient • Awarded $1.5 million from the FDA to run the Phase 2A and Phase 2B Clinical Trials • Patent awarded for formulation, additional patents pending

 

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NYSE American: TMBR 8 Investigator’s Global Assessment (IGA) Score -- 5 - Point Scale 0 Clear No scaling and no roughness, no fissure 1 Almost Clear Occasional fine scales, hardly palpable roughness (mostly smooth) no fissure 2 Mild Small and fine scales predominate, no more than a few large scales, mild roughness on palpation, few fissures may be present 3 Moderate Large rather thick scales predominate, coarse roughness on palpation, few fissures may be present 4 Severe Large coalescent scales dominate, sharp edges on palpation with plate - like hyperkeratosis, many fissures may be present

 

NYSE American: TMBR 9 TMB - 001 Topical Isotretinoin in CI Phase 2B Study Design (CONTROL Study) Title A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB - 001 for Treatment of Congenital Ichthyosis Primary Objective Proportion of subjects with Visual Index of Ichthyosis Severity (VIIS) treatment success, defined as 50% or greater decrease in VIIS scaling score Secondary Objectives • IGA decrease in disease severity by at least 2 grades • Patient Reported Outcomes (Itch, Dermatology Life Quality Index) Study Design • Randomized, parallel, double - blind, vehicle controlled study • Evaluating the safety and efficacy of two concentrations of topical TMB - 001 • Multi - center global trial (US and Australia) Study Population Moderate to Severe X - linked and Lamellar Ichthyosis 9 years and older Patient Number 34 patients Therapy Twice daily application Time Schedule 12 weeks

 

NYSE American: TMBR 10 TMB - 001 CONTROL Study - Efficacy Intent to Treat (ITT) 64% of the ITT Population in 0.05% dose achieved a 50% reduction in VIIIS score versus 33% in the vehicle group (nominal p=.17) 55% of the Per Protocol Population in 0.05% dose achieved a 2 point reduction in IGA versus 8% in the vehicle group (nominal p=.02)

 

NYSE American: TMBR 11 TMB - 001 CONTROL Study - Efficacy Per Protocol 100% of the Per Protocol Population in 0.05% dose achieved a 50% reduction in VIIIS score versus 40% in the vehicle group (nominal p=.04) 100% of the Per Protocol Population in 0.05% dose achieved a 2 point reduction in IGA versus 10% in the vehicle group (nominal p=.002)

 

NYSE American: TMBR 12 TMB - 001 CONTROL Study - 21 yr. old patient with Lamellar Ichthyosis (ALOX12B) - 0.05% arm (responder) End Of Study – Visit 6 Baseline

 

NYSE American: TMBR Significant Clinical Milestones on a Quarterly Basis over next 12 months 13 TMB - 001 TMB - 002 Q4 2021 Topline Data for Phase IIb Trial Completed Enrollment of Phase IIb Q1 2022 End of Phase II FDA Meeting Broad Phase IIb Data Dissemination Q2 2022 Anticipated Start of Phase III Program Q3 2022 Anticipated Topline Data Readout Q4 2022 End of Phase II FDA Meeting

 

www.timberpharma.com For additional Investor Information please contact: John Koconis Stephanie Prince Chairman and CEO PCG Advisory jkoconis@timberpharma.com sprince@pcgadvisory.com (646) 863 - 6341 NYSE American: TMBR