Timber Pharmaceuticals Provides Business Update and Announces Third Quarter 2021 Financial Results

 

Source:  Timber Pharmaceuticals, Inc. 11/15/2021

Positive Top Line Phase 2b Study Data for Lead Asset TMB-001 and Capital Raise of $17.25 Million Announced Subsequent to Quarter End

Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today provided a business update and announced financial results for the third quarter ended September 30, 2021.

John Koconis, Chairman and Chief Executive Officer of Timber, commented, “In the third quarter Timber was excited to complete the Phase 2b CONTROL Study of congenital ichthyosis for its lead asset, TMB-001. The positive topline data was released in early October and demonstrated clinically meaningful efficacy with a favorable safety profile that supports continued development. We believe this data readout helped us to raise gross proceeds of $17.25 million of new capital, positioning Timber to proceed on its path toward a Phase 3 study. The new capital will also be used to complete the Phase 2b clinical trial evaluating TMB-002 (topical rapamycin) which recently completed enrolment, of which the top line data readout is expected in the third quarter of 2022. With new capital in place, we look forward to continuing to advance toward meeting the needs of patients with rare and orphan dermatologic diseases.”

Recent Highlights

• Timber completed the Phase 2b CONTROL Study of congenital ichthyosis (CI) for its lead asset, TMB-001, during the third quarter and announced top line results subsequent to quarter end. TMB-001 is a topical isotretinoin formulated using Timber’s patented IPEG™ delivery system for patients with moderate to severe CI. Clinically meaningful efficacy with a favorable safety profile demonstrated the potential of TMB-001 to be an important option for the treatment of CI where no FDA-approved treatments are currently available and the standard of care is limited. Timber is planning for an end-of-Phase 2 meeting with the FDA in the beginning of 2022 and intends to begin the Phase 3 study of TMB-001 in the second quarter of 2022. 

• Recruitment was completed for the ongoing Phase 2b clinical trial evaluating TMB-002 for the treatment of facial angiofibromas (FAs) in tuberous sclerosis complex (TSC), near the end of the third quarter of 2021. Data is expected six months from the date that the last patient was enrolled, as per protocol.

• Timber ended the third quarter with $3.4 million in cash and common shares outstanding of 36.7 million at September 30, 2021, prior to the capital raise of gross proceeds of $17.25 million (inclusive of the over-allotment option) that closed in early November 2021, in which 26,953,125 shares and 26,953,125 warrants were issued.

• Timber recognized revenue of $266,974 in the third quarter of 2021, consisting of reimbursements as a result of achieving certain clinical milestones in the development of TMB-001, part of a $1.5 million grant from the FDA’s Orphan Products Clinical Trials Grants Program and from a TMB-002 milestone for a licensing agreement with AFT.

For Timber’s complete financial results for the period ended September 30, 2021, see the Company’s quarterly Form 10-Q filed with the Securities and Exchange Commission on November 15, 2021.

About Timber Pharmaceuticals, Inc.

Timber Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing and control) and safety profiles. The Company is initially focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI), facial angiofibromas (FAs) in tuberous sclerosis complex (TSC), and other sclerotic skin diseases. For more information, visit www.timberpharma.com.