Tarsus Pharmaceuticals, Inc. Reports Second Quarter 2021 Financial Results and Provides Business and Clinical Updates
August 04 2021 - 05:30PM
Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), a late clinical-stage
biopharmaceutical company 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 and provided business and clinical updates for
the quarter ended June 30, 2021.
“We have achieved significant milestones on our lead product and
pipeline so far in 2021 with the positive read-out of the Saturn-1
data for TP-03 in Demodex blepharitis, the initiation of Saturn-2,
and the initiation of the Callisto trial of TP-05 for the
prevention of Lyme disease,” said Bobak Azamian, M.D., Ph.D.,
President and Chief Executive Officer of Tarsus. “Interest from the
physician community also continues to build, as new Saturn-1 data
presented at the ASCRS 2021 Annual Meeting reinforced the strong
potential clinical utility of TP-03 with a broad range of patients
showing a substantial response. Additionally, results from the
Titan and Atlas studies reinforce the prevalence and burden of
Demodex blepharitis, suggesting that this disease could affect as
many as 25 million Americans, with 80% of patients reporting a
negative impact on daily life. We believe this data supports both
the need and opportunity for an FDA-approved therapeutic treatment
option.”
Recent Business Highlights and Corporate
Update:
- Announced positive results of the Phase 2b/3 Saturn-1 pivotal
trial studying TP-03 (lotilaner ophthalmic solution, 0.25%) in
patients with Demodex blepharitis. All pre-specified primary and
secondary endpoints were met, and complete resolution of Demodex
blepharitis signs was demonstrated in many patients treated with
TP-03 (lotilaner ophthalmic solution, 0.25%).
- 81% of patients on TP-03 achieved a clinically meaningful
collarette cure, defined as 0-10 collarettes per lid at day 43
compared to 23% of those on vehicle (p<0.0001).
- 44% of patients on TP-03 achieved the primary endpoint of
complete collarette cure, defined as 0-2 collarettes per lid at day
43, compared to 7% on vehicle (p<0.0001).
- 68% of patients on TP-03 achieved mite eradication defined as 0
mites per lash at day 43, compared to 18% on vehicle
(p<0.0001).
- Additionally, significant efficacy in lid erythema (redness)
was demonstrated across multiple measures including complete and
clinically meaningful composite cures, and in erythema alone.
Results showed 45% of patients improved erythema by one (1) grade
or more (compared to 28% of patients on vehicle, p=0.0002) and 19%
of patients on TP-03 achieved a complete erythema cure (compared to
7% of patients on vehicle, p<0.0001).
- TP-03 was well tolerated with a safety profile similar to the
vehicle group. Additionally, the vast majority of TP-03 patients
(92%) reported that the drop comfort was neutral to very
comfortable. There were no serious treatment-related adverse events
nor any treatment-related adverse events leading to treatment
discontinuation.
- Released new data from the Saturn-1 Phase 2b/3 pivotal trial at
the ASCRS 2021 Annual Meeting. The new Saturn-1 data reinforces the
strong potential clinical utility of TP-03 for the treatment of
Demodex blepharitis, with a broad range of patients showing a
substantial response.
- 95% of TP-03 patients showed a significant improvement in mite
count, achieving ≤0.5 mites per lash at day 43 from an average
baseline of 3.2 mites per lash, compared to 36% of those on vehicle
(p<0.0001).
- 93% of TP-03 patients improved by at least one collarette grade
or approximately 50 collarettes per lid by day 43, from an average
baseline of grade 2.8 or approximately 100 collarettes per lid,
compared to 50% of those on vehicle (p<0.0001).
- An additional Saturn-1 safety analysis also revealed that TP-03
had no clinically significant effect on multiple safety measures
including Corrected Distance Visual Acuity (CDVA), corneal
staining, and intraocular pressure (IOP), and no significant
findings from slit lamp biomicroscopy or fundus exam. In addition,
no impact to endothelial cell density (ECD) was seen in a subset of
21 patients. ECD will be further evaluated as part of the Saturn-2
trial plan.
- Presented data from the Titan real world prevalence study at
the ASCRS meeting. The Titan study is an IRB-approved,
retrospective chart review of 1,032 patients across six U.S.-based
ophthalmology and optometry practices, designed to better
understand the prevalence of collarettes in U.S. eye care clinics.
Collarettes, or cylindrical dandruff, are a pathognomonic sign of
Demodex blepharitis and are an accumulation of mite waste product
and eggs that form at the base of the eyelashes. In data presented
at ASCRS, the Titan study revealed the presence of collarettes in
58% (n=595) of patients. When projected across the U.S. population,
these results suggest that Demodex blepharitis could affect as many
as 25 million Americans. The study also revealed that the
prevalence of Demodex blepharitis is similar to that of dry eye
(58%, n=593).
- Commenced enrollment in Saturn-2, the second pivotal trial
evaluating TP-03 for the treatment of Demodex
blepharitis. Saturn-2 is a randomized, controlled,
multicenter, double-masked trial studying the safety and efficacy
of TP-03. The trial is expected to enroll 418 participants and has
a similar design to Saturn-1. Saturn-2’s primary endpoint is the
proportion of patients achieving collarette cure, defined as 0 to 2
collarettes per lid. Secondary endpoints include the eradication of
Demodex mites and the proportion of patients achieving a cure based
on a composite of collarette cure and erythema cure (eyelid
redness). Topline results for the study are anticipated in Q1 of
2022.
- Initiated the Phase 1 Callisto trial of TP-05, a novel, oral,
non-vaccine therapeutic, for the prevention of Lyme disease and
malaria. The Phase 1 Callisto trial is a single ascending dose and
multiple ascending dose trial designed to evaluate the safety,
tolerability, and pharmacokinetics (PK) of TP-05 in healthy
volunteers. There are currently no U.S. Food and Drug
Administration (FDA)-approved pharmacological prophylactic options
for Lyme disease, which is the most common vector-borne disease in
the United States, transmitted to humans through the infection of
the bacterium Borrelia burgdorferi following the bite of a tick
vector.
- Presented data from the Atlas study at the virtual Association
for Research in Vision and Ophthalmology (ARVO) 2021 Annual
Meeting. The Atlas study is believed to be the first
multi-center observational study to evaluate the functional and
psychosocial impact of Demodex blepharitis, along with clinical
manifestations, in adult patients. Overall, the study showed that
Demodex blepharitis is associated with a significant symptomatic
and psychosocial burden, negatively affecting daily life in the
majority (80%) of patients with the disease.
- Received $35 million in proceeds as part of the partnership
with LianBio; an additional $20 million is expected in Q3 2021 for
clinical milestones achieved in June 2021.
Second Quarter 2021 Financial Results
- Second quarter net income for 2021
was $6.3 million, compared to a net loss of $(3.3) million for the
same period in 2020.
- Second quarter 2021 license fee and
collaboration revenue, as part of strategic partnership with
LianBio, was $22.0 million; and $0.7 million in associated expense
in proportion to this revenue.
- Second quarter research and
development expenses for 2021 were $7.2 million (inclusive of
stock-based compensation of $0.4 million), compared to $1.7 million
for the same period in 2020.
- Second quarter general and
administrative expenses for 2021 increased to $6.8 million
(inclusive of stock-based compensation of $2.4 million), compared
to $1.5 million for the same period in 2020.
- As of June 30, 2021, cash and cash
equivalents were $176.7 million, and accounts receivable were $20
million for an achieved TP-03 clinical milestone.
About Tarsus Pharmaceuticals,
Inc.Tarsus Pharmaceuticals, Inc. is a late clinical-stage
biopharmaceutical company that 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 1 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 receipt by Tarsus of future payments and achievement
and timing of milestones under the terms of the collaboration with
LianBio, the ability of LianBio to commercialize TP-03 in the
Greater China territory, 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 and TP-05, the timing,
objectives and results of the clinical studies, 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 eye care physicians 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, 2020 filed with the SEC on March 31, 2021, and Form 10-Q for
the quarter ended June 30, 2021 filed with the SEC on August 4,
2021, 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 OhShop PR(917)
841-5213sujin@shop-pr.com
Investor Contact:Patti BankWestwicke Partners,
an ICR company(415) 513-1284IR@tarsusrx.com
TARSUS PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS)(In thousands, except
share and per share amounts)
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenues: |
|
|
|
|
|
|
|
License
fees |
$ |
19,048 |
|
|
— |
|
|
$ |
52,359 |
|
|
— |
|
Collaboration revenue |
2,969 |
|
|
— |
|
|
3,090 |
|
|
— |
|
Total
revenues |
22,017 |
|
|
— |
|
|
55,449 |
|
|
— |
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of
license fees and collaboration revenue |
737 |
|
|
— |
|
|
2,034 |
|
|
— |
|
Research
and development |
7,204 |
|
|
1,737 |
|
|
23,465 |
|
|
3,249 |
|
General
and administrative |
6,794 |
|
|
1,526 |
|
|
11,954 |
|
|
2,132 |
|
Total
operating expenses |
14,735 |
|
|
3,263 |
|
|
37,453 |
|
|
5,381 |
|
Income
(loss) from operations before other (expense) income and income
taxes |
7,282 |
|
|
(3,263 |
) |
|
17,996 |
|
|
(5,381 |
) |
Other
(expense) income: |
|
|
|
|
|
|
|
Interest
income (expense), net |
7 |
|
|
13 |
|
|
16 |
|
|
174 |
|
Other
(expense) income, net |
(39 |
) |
|
— |
|
|
(73 |
) |
|
— |
|
Change
in fair value of equity warrant rights |
(876 |
) |
|
— |
|
|
(876 |
) |
|
— |
|
Total
other (expense) income |
(908 |
) |
|
13 |
|
|
(933 |
) |
|
174 |
|
Provision for income taxes |
(29 |
) |
|
— |
|
|
(342 |
) |
|
— |
|
Net income (loss) and comprehensive income (loss) |
$ |
6,345 |
|
|
$ |
(3,250 |
) |
|
$ |
16,721 |
|
|
$ |
(5,207 |
) |
Net
income (loss) per share |
|
|
|
|
|
|
|
Basic |
$ |
0.31 |
|
|
$ |
(1.23 |
) |
|
$ |
0.81 |
|
|
$ |
(1.96 |
) |
Diluted |
$ |
0.29 |
|
|
$ |
(1.23 |
) |
|
$ |
0.76 |
|
|
$ |
(1.96 |
) |
Weighted-average shares outstanding |
|
|
|
|
|
|
|
Basic |
20,555,258 |
|
|
2,651,321 |
|
|
20,446,246 |
|
|
2,650,843 |
|
Diluted |
21,966,599 |
|
|
2,651,321 |
|
|
21,895,304 |
|
|
2,650,843 |
|
|
|
|
|
|
|
|
|
|
|
|
|
TARSUS PHARMACEUTICALS, INC.
BALANCE SHEETS(In
thousands, except share and par value amounts)
|
June 30, 2021 |
|
December 31, 2020 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
176,735 |
|
|
$ |
168,129 |
|
Restricted cash |
— |
|
|
20 |
|
Accounts
receivable |
20,000 |
|
|
— |
|
Other
receivables |
157 |
|
|
20 |
|
Prepaid
expenses and other current assets |
4,012 |
|
|
2,486 |
|
Total current assets |
200,904 |
|
|
170,655 |
|
Property and equipment, net of
accumulated depreciation |
481 |
|
|
548 |
|
Operating lease right-of-use
asset |
540 |
|
|
688 |
|
Other assets |
1,525 |
|
|
81 |
|
Total assets |
$ |
203,450 |
|
|
$ |
171,972 |
|
LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS’
EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and other
accrued liabilities |
$ |
8,985 |
|
|
$ |
4,347 |
|
Accrued payroll and
benefits |
1,470 |
|
|
1,040 |
|
Total current liabilities |
10,455 |
|
|
5,387 |
|
Other long-term
liabilities |
524 |
|
|
605 |
|
Total liabilities |
10,979 |
|
|
5,992 |
|
Commitments and contingencies (Note 9) |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 authorized at
June 30, 2021 and December 31, 2020; no shares issued and
outstanding at June 30, 2021 and December 31, 2020 |
— |
|
|
— |
|
Common
stock, $0.0001 par value; 200,000,000 shares authorized; 20,704,104
shares issued and 20,573,951 outstanding, which excludes 130,153
shares subject to repurchase at June 30, 2021 (unaudited);
20,502,576 shares issued and 20,323,301 outstanding, which excludes
179,375 shares subject to repurchase at December 31, 2020 |
4 |
|
|
4 |
|
Additional paid-in
capital |
208,591 |
|
|
198,821 |
|
Accumulated deficit |
(16,124 |
) |
|
(32,845 |
) |
Total stockholders’ equity |
192,471 |
|
|
165,980 |
|
Total liabilities, preferred stock and stockholders’
equity |
$ |
203,450 |
|
|
$ |
171,972 |
|
|
|
|
|
|
|
|
|
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