Tarsus Pharmaceuticals, Inc. Reports Full-Year 2021 Financial Results and Recent Business Achievements
March 14 2022 - 3:05PM
Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to
focus on unmet needs and apply proven science and new technology to
revolutionize treatment for patients, starting with eye care, today
announced financial results for the full-year ended December 31,
2021 and recent business achievements.
“During the last 12 months we made significant progress and
built considerable momentum towards becoming a leading eye care
pharmaceutical company. We completed enrollment in the Phase 3
Saturn-2 trial, the second pivotal trial of TP-03 and potentially
first FDA approved therapy for Demodex blepharitis, a lid margin
disease affecting approximately 25 million people in the U.S. The
Saturn-2 trial is similar in size and design to our successful
Saturn-1 trial that met all endpoints and demonstrated clinically
meaningful outcomes in resolving Demodex blepharitis,” said Bobak
Azamian, M.D., Ph.D., President and Chief Executive Officer of
Tarsus. “We enter 2022 well positioned to deliver Saturn-2 topline
data in April, submit the NDA this year for TP-03, a potential
blockbuster therapeutic. Our financial strength enables us to
advance our pipeline and commercial capabilities to drive
meaningful value for patients and our
stockholders.”
Recent Business Highlights and Corporate
Update
- Completed enrollment in the Saturn-2 Phase 3 trial, the second
pivotal trial of TP-03, a potential pioneering therapeutic for
Demodex blepharitis (DB)
- Pivotal topline data expected in April 2022, which, if
positive, is expected to be followed by an NDA submission later
this year
- The trial is designed to evaluate the same primary and
secondary endpoints as the pivotal Saturn-1 trial in which TP-03
met all endpoints and was well-tolerated
- Reported positive pivotal Saturn-1 trial results emphasizing
the potential of TP-03 to be the standard of care for DB patients
- Met primary endpoint of collarette cure, additional endpoints
of mite eradication and lid erythema (redness) cure, and
demonstrated clinically meaningful outcomes in resolving DB
- Well-tolerated with a safety profile similar to the vehicle
group
- Expanded market awareness and increased physician focus on DB
- Presented data from Titan and Atlas studies estimating there
are approximately 25 million DB patients in the U.S. and DB
negatively affecting daily life in 80% of patients
- Growing physician awareness and focus of recent major medical
meetings and educational programs
- Published three peer reviewed papers in the second half of 2021
and expect at least four in the first half of 2022
- Advanced TP-05, a novel, oral, non-vaccine potential
therapeutic for the prevention of Lyme disease, into the Callisto
Phase 1b trial with data expected in the second half of 2022
- Callisto is a single and multiple ascending dose trial to
evaluate safety, tolerability and pharmacokinetics of TP-05 in
healthy volunteers
- There are approximately 80 million people in the U.S. at risk
for Lyme disease exposure, more than 30 million of which are at
moderate-to-high risk, which can result in severe neurological and
other debilitating symptoms
- Expanded executive leadership team with the appointment of Jose
Trevejo, M.D., Ph.D., as Chief Medical Officer
- Dr. Trevejo has over 20 years of experience advancing the
clinical development of novel therapeutics, in particular
infectious diseases, which will be impactful in furthering our
anti-parasitic platform across multiple indications, including Lyme
disease prevention, community malaria reduction, rosacea and
meibomian gland disease
- Appointed two industry leaders to our Board of Directors
- Elizabeth Yeu, M.D., a nationally recognized Ophthalmologist
and Eye Care leader will continue to serve as Chief Medical Advisor
and joined the Science and Technology Committee, focused on
innovation and pipeline opportunities
- Rosemary A. Crane, a healthcare leader with more than 30 years
of pharmaceutical industry experience serves as the Chair of the
Science and Technology Committee and the Audit Committee
- Secured $175 million non-dilutive credit facility providing
significant financial optionality as we prepare for the expected
NDA submission, commercial launch of TP-03, and advancement and
expansion of our pipeline
- Received $55 million to date from our TP-03 out-license in
Greater China and we expect to receive $30 million in milestones in
2022
Anticipated 2022 Milestones
Program |
Milestone |
Anticipated Indication |
H1 2022 |
H2 2022 |
TP-03 |
Topline Pivotal Data (Saturn-2) |
Demodex blepharitis |
● |
|
TP-03 |
Initiate Phase 2 (Ersa) |
Meibomian Gland Disease |
● |
|
TP-03 |
NDA Submission |
Demodex blepharitis |
|
● |
TP-04 |
Initiate Phase 2 (Galatea) |
Rosacea |
|
● |
TP-05 |
Phase 1b Data (Callisto) |
Lyme disease prevention |
|
● |
TP-03 |
Initiate Phase 3 trial in China |
Demodex blepharitis |
|
● |
Full-Year 2021 Financial
Results
- Full year net loss
was $13.8 million, compared to $26.8 million in 2020
- Full year research and development
expenses were $41.7 million, compared to $18.8 million in 2020
- Full year general and
administrative expenses were $25.4 million, compared to $8.2
million in 2020
- As of December 31, 2021, cash, cash
equivalents and marketable securities were $171.8 million
About Tarsus Pharmaceuticals,
Inc.
Tarsus Pharmaceuticals, Inc. applies proven science and new
technology to revolutionize treatment for patients, starting with
eye care. It is advancing its pipeline to address several diseases
with high unmet need across a range of therapeutic categories,
including eye care, dermatology, and infectious disease prevention.
The company is studying two investigational medicines in clinical
trials. Its lead product candidate, TP-03, is a novel therapeutic
being studied in a second Phase 3 pivotal trial for the treatment
of Demodex blepharitis. TP-03 is also being developed for the
treatment of Meibomian Gland Disease. In addition, Tarsus is
developing TP-05, an oral, non-vaccine therapeutic for the
prevention of Lyme disease, which is currently being studied in a
Phase 1b clinical trial.
Forward-Looking Statements
Statements in this press release about future expectations,
plans and prospects, as well as any other statements regarding
matters that are not historical facts, may constitute
“forward-looking statements.” These statements include statements
regarding the Company’s estimates on its cash runway; the receipt
by Tarsus of future payments and achievement and timing of
milestones under the terms of the collaboration with LianBio, the
potential market size for TP-03 and TP-05, future events and
Tarsus’ plans for and the anticipated benefits of its product
candidates including TP-03, TP-04 and TP-05, the impact of recent
new hires, the timing, objectives and results of the clinical
trials including the potential clinical results of the Saturn-2
trial, anticipated regulatory and development milestones and the
quotations of Tarsus’ management. The words, without limitation,
“believe,” “contemplate,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” or “would,” or the negative
of these terms or other similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these or similar identifying
words. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors. Important factors that could cause actual results to
differ materially from those in the forward-looking statements
include: Tarsus has incurred significant losses and negative cash
flows from operations since inception and anticipates that it will
continue to incur significant expenses and losses for the
foreseeable future; Tarsus may need to obtain additional funding to
complete the development and any commercialization of its product
candidates, if approved; Tarsus is heavily dependent on the success
of its lead product candidate, TP-03 for the treatment of Demodex
blepharitis; the COVID-19 pandemic may affect Tarsus’ ability to
initiate and complete preclinical studies and clinical trials,
disrupt regulatory activities, disrupt manufacturing and supply
chain or have other adverse effects on Tarsus’ business and
operations; even if TP-03, TP-05, or any other product candidate
that Tarsus develops receives marketing approval, Tarsus may not be
successful in educating healthcare professionals and the market
about the need for treatments specifically for Demodex blepharitis,
Lyme disease, and/or other diseases or conditions targeted by
Tarsus’ products; the development and commercialization of Tarsus
products is dependent on intellectual property it licenses from
Elanco Tiergesundheit AG; Tarsus will need to develop and expand
the company and Tarsus may encounter difficulties in managing its
growth, which could disrupt its operations; the sizes of the market
opportunity for Tarsus’ product candidates, particularly TP-03 for
the treatment of Demodex blepharitis and MGD, as well as TP-05 for
the treatment of Lyme disease, have not been established with
precision and may be smaller than estimated; the results of Tarsus’
earlier studies and trials may not be predictive of future results;
any termination or suspension of, or delays in the commencement or
completion of, Tarsus’ planned clinical trials could result in
increased costs, delay or limit its ability to generate revenue and
adversely affect its commercial prospects; and if Tarsus is unable
to obtain and maintain sufficient intellectual property protection
for its product candidates, or if the scope of the intellectual
property protection is not sufficiently broad, Tarsus’ competitors
could develop and commercialize products similar or identical to
Tarsus’ products. Further, there are other risks and uncertainties
that could cause actual results to differ from those set forth in
the forward-looking statement and they are detailed from time to
time in the reports Tarsus files with the Securities and Exchange
Commission, including Tarsus’ Form 10-K for the year ended December
31, 2021 filed on March 14, 2022 with the SEC, which Tarsus
incorporates by reference into this press release, copies of which
are posted on its website and are available from Tarsus without
charge. However, new risk factors and uncertainties may emerge from
time to time, and it is not possible to predict all risk factors
and uncertainties. Accordingly, readers are cautioned not to place
undue reliance on these forward-looking statements. Any
forward-looking statements contained in this press release are
based on the current expectations of Tarsus’ management team and
speak only as of the date hereof, and Tarsus specifically disclaims
any obligation to update any forward-looking statement, whether as
a result of new information, future events or otherwise.
Media
Contact: |
|
SuJin Oh |
|
twelvenote |
|
(917) 841-5213 |
|
soh@twelvenote.com |
|
|
|
Investor
Contact: |
|
David Nakasone |
|
Head of Investor
Relations |
|
(949) 620-3223 |
|
DNakasone@tarsusrx.com |
|
TARSUS PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(In thousands, except share and
per share amounts)
|
Year Ended December 31, |
|
|
2021 |
|
|
|
2020 |
|
Revenues: |
|
|
|
License fees |
$ |
53,067 |
|
|
$ |
— |
|
Collaboration revenue |
|
3,960 |
|
|
|
— |
|
Total revenues |
|
57,027 |
|
|
|
— |
|
Operating
expenses: |
|
|
|
Cost of license fees and collaboration revenue |
$ |
2,075 |
|
|
$ |
— |
|
Research and development |
|
41,712 |
|
|
|
18,826 |
|
General and administrative |
|
25,397 |
|
|
|
8,172 |
|
Total operating expenses |
|
69,184 |
|
|
|
26,998 |
|
Loss from operations before other
(expense) income and income taxes |
|
(12,157 |
) |
|
|
(26,998 |
) |
Other (expense) income: |
|
|
|
Interest income |
|
36 |
|
|
|
188 |
|
Other expense, net |
|
(73 |
) |
|
|
— |
|
Unrealized loss on equity securities |
|
(591 |
) |
|
|
— |
|
Change in fair value of equity warrant rights |
|
(987 |
) |
|
|
— |
|
Total other (expense) income, net |
|
(1,615 |
) |
|
|
188 |
|
Loss from operations before
income taxes |
|
(13,772 |
) |
|
|
(26,810 |
) |
Provision for income taxes |
|
(55 |
) |
|
|
(1 |
) |
Net loss and comprehensive
loss |
$ |
(13,827 |
) |
|
$ |
(26,811 |
) |
Net loss per share, basic and
diluted |
$ |
(0.67 |
) |
|
$ |
(4.32 |
) |
Weighted-average shares
outstanding used in computing net loss per share, basic and
diluted |
|
20,554,086 |
|
|
|
6,207,367 |
|
TARSUS PHARMACEUTICALS, INC.
BALANCE SHEETS(In
thousands, except share and par value amounts)
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
171,332 |
|
|
$ |
168,129 |
|
Marketable securities |
|
483 |
|
|
|
— |
|
Restricted cash |
|
— |
|
|
|
20 |
|
Other receivables |
|
92 |
|
|
|
20 |
|
Prepaid expenses and other
current assets |
|
4,045 |
|
|
|
2,486 |
|
Total current assets |
|
175,952 |
|
|
|
170,655 |
|
Property and equipment,
net |
|
755 |
|
|
|
548 |
|
Operating lease right-of-use
assets |
|
1,074 |
|
|
|
688 |
|
Other assets |
|
1,126 |
|
|
|
81 |
|
Total
assets |
$ |
178,907 |
|
|
$ |
171,972 |
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and other
accrued liabilities |
$ |
8,680 |
|
|
$ |
4,347 |
|
Accrued payroll and
benefits |
|
2,798 |
|
|
|
1,040 |
|
Total current liabilities |
|
11,478 |
|
|
|
5,387 |
|
Other long-term
liabilities |
|
699 |
|
|
|
605 |
|
Total
liabilities |
|
12,177 |
|
|
|
5,992 |
|
Commitments and
contingencies (Note
8) |
|
|
|
Stockholders’
equity: |
|
|
|
Preferred stock, $0.0001 par
value; 10,000,000 shares authorized; no shares issued and
outstanding |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value;
200,000,000 shares authorized; 20,726,580 shares issued and
20,698,737 outstanding, which excludes 27,840 shares subject to
repurchase at December 31, 2021; 20,502,576 shares issued and
20,323,201 outstanding, which excludes 179,375 shares subject to
repurchase at December 31, 2020 |
|
4 |
|
|
|
4 |
|
Additional paid-in
capital |
|
213,398 |
|
|
|
198,821 |
|
Accumulated deficit |
|
(46,672 |
) |
|
|
(32,845 |
) |
Total stockholders’
equity |
|
166,730 |
|
|
|
165,980 |
|
Total liabilities and
stockholders’ equity |
$ |
178,907 |
|
|
$ |
171,972 |
|
Tarsus Pharmaceuticals (NASDAQ:TARS)
Historical Stock Chart
From Apr 2024 to May 2024
Tarsus Pharmaceuticals (NASDAQ:TARS)
Historical Stock Chart
From May 2023 to May 2024