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 it has completed enrollment of Saturn-2, the company’s
second pivotal Phase 3 trial of TP-03 (lotilaner ophthalmic
solution, 0.25%) for patients with Demodex blepharitis and executed
a $175 million credit facility with Hercules Capital, Inc. (NYSE:
HTGC) and Silicon Valley Bank (NASDAQ: SIVB).
Saturn-2 Enrollment Completion “We are
delighted Saturn-2 has completed enrollment with 408 patients
during these challenging times, which speaks to the urgent need for
an effective treatment for people living with Demodex blepharitis.
We are committed to developing a solution for this disease as
rapidly as possible and expect to share topline results from
Saturn-2 in April, which, if positive, will be followed by a New
Drug Application for TP-03 planned this year,” said Bobak Azamian,
M.D., Ph.D., President and Chief Executive Officer of Tarsus.
Saturn-2 is a Phase 3 randomized, controlled, double-masked
trial evaluating the efficacy and safety of TP-03 in patients with
Demodex blepharitis. The primary endpoint is the proportion of
patients achieving complete collarette cure, defined as 0 to 2
collarettes per lid and secondary endpoints are mite eradication,
lid margin erythema (redness) cure and a composite of collarette
and erythema cures. Saturn-2 has similar powering assumptions and
design to the completed pivotal Saturn-1 trial, which successfully
met the primary and all secondary endpoints. Tarsus expects topline
results for the Saturn-2 trial in April and if the results are
positive, data from both the Saturn-1 and Saturn-2 trials will
support submission of a New Drug Application (NDA) for TP-03 for
the treatment of Demodex blepharitis planned for later this
year.
Credit Facility with Hercules Capital and Silicon Valley
Bank “We are also grateful to secure this non-dilutive
$175 million credit facility, providing Tarsus with significant
financial flexibility to drive our business growth as we continue
to pioneer the treatment landscape for patients with Demodex
blepharitis and other important diseases,” said Dr. Azamian. “With
these developments, we are on track to advance and expand our
pipeline, including delivering pivotal Phase 3 data from Saturn-2,
submitting the TP-03 NDA for Demodex blepharitis, and if approved,
be well-positioned for our expected commercial launch of TP-03 next
year.”
“Hercules is proud to partner with Tarsus ahead of several
important milestones in the advancement of TP-03 and other
programs. This is a significant commitment given our excitement
around the positive clinical evidence and the potential for TP-03
to improve the treatment paradigm for patients with Demodex
blepharitis,” said Himani Bhalla, Managing Director at Hercules
Capital.
“The team at Silicon Valley Bank is happy to work with Tarsus’
leadership team to provide this facility and support the important
work they are doing to revolutionize treatments for patients with
Demodex blepharitis,” said Michael White, Managing Director,
Business Development, Life Sciences & Healthcare at Silicon
Valley Bank.
Availability under this credit facility potentially extends cash
runway well into the anticipated commercialization of TP-03. The
$175 million is available as follows: $40 million at closing with
$20 million drawn, $25 million at TP-03 NDA submission, $35 million
at TP-03 FDA approval, and $75 million upon achievement of certain
revenue thresholds and other conditions. The interest-only period
is four years and is extendable to five years upon meeting certain
conditions. Future draws are at Tarsus’ election and there is no
warrant coverage to the lenders.
Additional details of the credit facility agreement are filed
with the Securities and Exchange Commission on a Current Report on
Form 8-K.
Armentum Partners served as Tarsus’ financial advisor in
connection with this credit facility.
About TP-03TP-03 (lotilaner ophthalmic
solution, 0.25%) is a novel, investigational therapeutic designed
to resolve the signs of Demodex blepharitis by targeting and
eradicating the root cause of the disease – Demodex mite
infestation. Lotilaner is a well-characterized anti-parasitic agent
that paralyzes and eradicates Demodex mites by selectively
inhibiting the GABA-Cl channels. It is a highly lipophilic
molecule, which may promote its uptake in the oily sebum of the
hair follicle where the mites reside. TP-03 was evaluated in the
pivotal Saturn-1 (Phase 2b/3) trial involving 421 patients and
successfully met the primary and secondary endpoints with no
serious treatment-related adverse events and was well tolerated.
TP-03 is currently being evaluated in the Saturn-2 (Phase 3)
pivotal trial. If approved, TP-03 may potentially offer treatment
for millions of patients around the world with Demodex
blepharitis.
About Demodex BlepharitisBlepharitis is a
common lid margin disease that is characterized by eyelid margin
inflammation, redness and ocular irritation. Demodex blepharitis is
caused by an infestation of Demodex mites, the most common
ectoparasite found on humans and accounts for over two-thirds of
all blepharitis cases. Demodex blepharitis may affect as many as 25
million Americans based on an extrapolation from the Titan study
indicating 58% of patients presenting to U.S. eye care clinics have
collarettes, a pathognomonic sign of Demodex infestation, and that
at least 45 million people annually visit an eye care clinic.
Demodex blepharitis can have a significant clinical burden and
negatively impact patients’ daily lives. The Titan study also
showed that current management tools, such as tea tree oil and lid
wipes, are ineffective at treating Demodex blepharitis. Currently,
there are no FDA-approved treatments for Demodex blepharitis.
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. 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 StatementsStatements 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 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 timing, objectives and results of the clinical
trials, anticipated regulatory and development milestones, future
financial condition and position, 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
and 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, 2020 filed on March 31, 2021 and
the most recent Form 10-Q quarterly filing for the quarter ending
September 30, 2021 filed on November 10, 2021 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.
Contacts: Media Contact:SuJin Oh
twelvenote(917) 841-5213soh@twelvenote.com
Investor Contact:David NakasoneHead of Investor Relations(949)
620-3223DNakasone@tarsusrx.com
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