Timber Pharmaceuticals Provides Business Update and Announces Third Quarter 2021 Financial Results
November 15 2021 - 4:15PM
via NewMediaWire -- 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, partof 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.
Forward-Looking Statements
This press release contains certain
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934 and Private Securities Litigation Reform Act, as
amended, including those relating to the Company's product
development, clinical and regulatory timelines, market opportunity,
competitive position, intellectual property rights, possible or
assumed future results of operations, business strategies,
potential growth opportunities and other statements that are
predictive in nature. These forward-looking statements are based on
current expectations, estimates, forecasts and projections about
the industry and markets in which we operate and management's
current beliefs and assumptions.
These statements may be identified by the use of
forward-looking expressions, including, but not limited to,
"expect," "anticipate," "intend," "plan," "believe," "estimate,"
"potential, "predict," "project," "should," "would" and similar
expressions and the negatives of those terms. These statements
relate to future events or our financial performance and involve
known and unknown risks, uncertainties, and other factors which may
cause actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Such
factors include those set forth in the Company's Annual Report on
Form 10-K for the year ended December 31, 2020 as well as other
documents filed by the Company from time to time thereafter with
the Securities and Exchange Commission. Prospective investors are
cautioned not to place undue reliance on such forward-looking
statements, which speak only as of the date of this press release.
The Company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
For more information, contact:
Timber Pharmaceuticals, Inc.John KoconisChairman
and Chief Executive Officerjkoconis@timberpharma.com
Investor Relations:Stephanie PrincePCG
Advisory(646) 863-6341sprince@pcgadvisory.com
Media Relations:Jenna UrbanBerry & Company
Public Relations(212) 253-8881jurban@berrypr.com
- Tables Follow -
Timber Pharmaceuticals, Inc. &
SubsidiariesCondensed Consolidated Balance
Sheets
|
|
|
30-Sep-21 |
|
31-Dec-20 |
|
(unaudited) |
|
|
|
|
|
|
|
|
$ |
3,357,136 |
|
$ |
10,348,693 |
|
338,200 |
|
|
377,290 |
|
3,695,336 |
|
|
10,725,983 |
|
127,534 |
|
|
114,534 |
|
17,012 |
|
|
— |
|
712,902 |
|
|
787,432 |
$ |
4,552,784 |
|
$ |
11,627,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,042,290 |
|
$ |
395,049 |
|
659,865 |
|
|
768,661 |
|
313,996 |
|
|
217,651 |
|
2,016,151 |
|
|
1,381,361 |
|
37,772 |
|
|
37,772 |
|
419,683 |
|
|
579,455 |
|
37,842 |
|
|
37,842 |
|
73,683 |
|
|
73,683 |
|
2,585,131 |
|
|
2,110,113 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,018,663 |
|
|
1,909,805 |
|
|
|
|
|
|
|
|
|
|
|
36,660 |
|
|
27,132 |
|
26,003,593 |
|
|
25,826,295 |
|
(26,091,263) |
|
|
(18,245,396) |
|
(51,010) |
|
|
7,608,031 |
$ |
4,552,784 |
|
$ |
11,627,949 |
Timber Pharmaceuticals, Inc. &
SubsidiariesCondensed Consolidated
Statements of Operations(Unaudited)
|
|
Three Months Ended September 30 |
|
Nine Months Ended September 30 |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant
revenue |
|
$ |
225,128 |
|
$ |
324,521 |
|
$ |
400,789 |
|
$ |
351,428 |
Milestone
revenue |
|
|
41,846 |
|
|
— |
|
|
295,738 |
|
|
— |
Total revenue |
|
|
266,974 |
|
|
324,521 |
|
|
696,527 |
|
|
351,428 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
1,974,193 |
|
|
685,207 |
|
|
4,623,811 |
|
|
2,239,607 |
Research and development - license acquired |
|
|
— |
|
|
— |
|
|
— |
|
|
12,371,332 |
Transaction costs |
|
|
— |
|
|
— |
|
|
— |
|
|
1,501,133 |
Selling, general and administrative |
|
|
1,296,641 |
|
|
1,233,849 |
|
|
3,918,042 |
|
|
2,745,728 |
Total operating expenses |
|
|
3,270,834 |
|
|
1,919,056 |
|
|
8,541,853 |
|
|
18,857,800 |
Loss from
operations |
|
|
(3,003,860) |
|
|
(1,594,535) |
|
|
(7,845,326) |
|
|
(18,506,372) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
(expense) income |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
— |
|
|
— |
|
|
— |
|
|
(4,416,746) |
Interest income |
|
|
— |
|
|
— |
|
|
— |
|
|
816,655 |
Change in fair value of investment in BioPharmX |
|
|
— |
|
|
— |
|
|
— |
|
|
559,805 |
Change in fair value of warrant liability |
|
|
— |
|
|
4,423,833 |
|
|
— |
|
|
5,607,293 |
Gain on foreign currency exchange |
|
|
(1,544) |
|
|
7,197 |
|
|
(541) |
|
|
11,651 |
Total other (expense) income |
|
|
(1,544) |
|
|
4,431,030 |
|
|
(541) |
|
|
2,578,658 |
Net (loss)
income |
|
|
(3,005,404) |
|
|
2,836,495 |
|
|
(7,845,867) |
|
|
(15,927,714) |
Accrued dividend on preferred stock units |
|
|
— |
|
|
— |
|
|
— |
|
|
(52,669) |
Cumulative dividends on Series A preferred stock |
|
|
(36,685) |
|
|
(36,685) |
|
|
(108,858) |
|
|
(53,831) |
Net (loss)
income attributable to common stockholders |
|
$ |
(3,042,089) |
|
$ |
2,799,810 |
|
$ |
(7,954,725) |
|
$ |
(16,034,214) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net
(loss) income per share attributable to common
stockholders |
|
$ |
(0.08) |
|
$ |
0.15 |
|
$ |
(0.22) |
|
$ |
(1.32) |
Diluted net
(loss) income per share attributable to common
stockholders |
|
$ |
(0.08) |
|
$ |
0.14 |
|
$ |
(0.22) |
|
$ |
(1.32) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average
number of shares outstanding |
|
|
36,659,685 |
|
|
18,891,206 |
|
|
35,873,780 |
|
|
12,160,048 |
Diluted weighted average
number of shares outstanding |
|
|
36,659,685 |
|
|
19,357,370 |
|
|
35,873,780 |
|
|
12,160,048 |
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