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Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="font-size:12pt;visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:top;width:43%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_4_25_2022_To_4_25_2022_xpBwE70KYU-yxMsPNaRMdw" format="ixt-sec:exchnameen" name="dei:SecurityExchangeName" id="Tc_9D5Jxyd8jEGEWd7_JM5vtQ_2_4">The NYSE American, LLC</ix:nonNumeric></p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">&#160;</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167;240.12b-2 of this 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<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><a id="_7c94becf_6d84_41cb_b8a9_6214a3a37846"></a><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><span style="display:inline-block;text-align:left;text-indent:0pt;width:72pt;"><b style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:bold;">Item 8.01 </b></span><b style="font-weight:bold;">Other Events. </b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">Timber Pharmaceuticals,&#160;Inc. (the &#8220;Company&#8221;), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for orphan dermatologic diseases, is providing an update on its clinical development programs.&#160; In light of recent market developments regarding TMB-002, the Company has completed its strategic evaluation and will be prioritizing the advancement of its lead product candidate TMB-001 (topical isotretinoin) for the treatment of moderate to severe subtypes of congenital ichthyosis (CI). It expects to initiate a Phase 3 clinical trial in the second quarter of 2022.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">Earlier this month, Nobelpharma America LLC announced that its sirolimus topical gel for facial angiofibromas associated with tuberous sclerosis complex (TSC) had been approved by the U.S. Food and Drug Administration (FDA).&#160; Nobelpharma&#8217; s formulation has orphan drug status for this indication. As the Company&#8217;s product TMB-002, a topical rapamycin cream, is intended for treatment of the same indication, the Company does not intend to proceed with a pivotal Phase 3 clinical trial of TMB-002 in facial angiofibromas at this time, but instead may evaluate potential strategic opportunities for the asset&#160;in markets outside of the U.S. and/or other indications.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">&#8220;We are encouraged by the growing interest in addressing orphan dermatologic diseases and the clinical success that TMB-001 has shown to date. TMB-001 has the potential to be the first FDA approved therapy for Congenital Ichthyosis and to significantly improve the lives of patients suffering from this condition. Therefore, we are focusing our resources behind this program in order to advance its development as quickly as possible. We are focused on launching the Phase 3 ASCEND study evaluating TMB-001 in CI within the next 60 days, following positive top-line results from our Phase 2b CONTROL study and the successful completion of an end-of-Phase 2 meeting with the FDA,&#8221; said John Koconis, Chairman and Chief Executive Officer of Timber.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:12pt;visibility:hidden;">&#8203;</span></p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><a id="_dd3afde8_9fc7_470d_8d4a_647985cc9b9d"></a><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">SIGNATURE</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="font-weight:bold;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">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.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:top;width:49.63%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"></div></div></td><td style="vertical-align:top;width:5.71%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"></div></div></td><td style="vertical-align:top;width:44.64%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"></div></div></td></tr><tr><td style="vertical-align:top;width:49.63%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">&#160;</p></td><td colspan="2" style="vertical-align:top;width:50.36%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;text-transform:uppercase;">Timber Pharmaceuticals, Inc.</b> </p></td></tr><tr><td style="vertical-align:top;width:49.63%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">&#160;</p></td><td colspan="2" style="vertical-align:top;width:50.36%;margin:0pt;padding:0pt;"><p 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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):
April 25, 2022
​
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 8.01
Other Events.
​
​
Timber Pharmaceuticals, Inc. (the "Company"), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for orphan dermatologic diseases, is providing an update on its clinical development programs.  In light of recent market developments regarding TMB-002, the Company has completed its strategic evaluation and will be prioritizing the advancement of its lead product candidate TMB-001 (topical isotretinoin) for the treatment of moderate to severe subtypes of congenital ichthyosis (CI). It expects to initiate a Phase 3 clinical trial in the second quarter of 2022.
​
Earlier this month, Nobelpharma America LLC announced that its sirolimus topical gel for facial angiofibromas associated with tuberous sclerosis complex (TSC) had been approved by the U.S. Food and Drug Administration (FDA).  Nobelpharma' s formulation has orphan drug status for this indication. As the Company's product TMB-002, a topical rapamycin cream, is intended for treatment of the same indication, the Company does not intend to proceed with a pivotal Phase 3 clinical trial of TMB-002 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.
​
"We are encouraged by the growing interest in addressing orphan dermatologic diseases and the clinical success that TMB-001 has shown to date. TMB-001 has the potential to be the first FDA approved therapy for Congenital Ichthyosis and to significantly improve the lives of patients suffering from this condition. Therefore, we are focusing our resources behind this program in order to advance its development as quickly as possible. We are focused on launching the Phase 3 ASCEND study evaluating TMB-001 in CI within the next 60 days, following positive top-line results from our Phase 2b CONTROL study and the successful completion of an end-of-Phase 2 meeting with the FDA," said John Koconis, Chairman and Chief Executive Officer of Timber.
​
​
​
​
​
​
​
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: April 25, 2022
By:
/s/ John Koconis
Name:
John Koconis
Title:
Chief Executive Officer and Chairman of the Board
​
​
​
​
​
​
​