Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (date of earliest event reported): August 11, 2022
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation)(Commission File Number)(I.R.S. Employer Identification No.)
15440 Laguna Canyon Road, Suite 160
Irvine, CA 92618
(Address of principal executive offices, including Zip Code)
Registrant's telephone number, including area code: (949) 409-9820
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.0001 par value per shareTARS
The Nasdaq Stock Market LLC
Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Item 2.02 Results of Operations and Financial Condition.

On August 11, 2022, Tarsus Pharmaceuticals, Inc. (the “Company”) issued a press release, which, among other matters, sets forth the Company’s results of operations for the three and six months ended June 30, 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The foregoing information, including Exhibit 99.1, is being furnished under Item 2.02 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.
Exhibit No.
104Cover Page Interactive Data File (embedded within XBRL document)


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: August 11, 2022

/s/ Leonard M. Greenstein
Leonard M. Greenstein
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)



Tarsus Reports Second Quarter 2022 Financial Results and Recent Business Achievements

TP-03 for the treatment of Demodex blepharitis met all endpoints in the Saturn-2 Phase 3 trial; NDA submission expected this year

Initiated Ersa Phase 2a trial evaluating TP-03 for the treatment of Meibomian Gland Disease

Cash runway anticipated into at least 2026 for the commercial launch of TP-03 and continued pipeline development

IRVINE, Calif., August 11, 2022 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for eye diseases, today announced financial results for the second quarter ended June 30, 2022, and recent business achievements.

“We continued to execute on our top priority of advancing TP-03 for the treatment of Demodex blepharitis, including preparing for NDA submission this year. We are also expanding the commercial team and seeing growing disease awareness as we generate momentum towards a potential commercial launch next year,” said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. “Simultaneously, we’ve taken positive steps to advance our pipeline, including initiating our clinical program for MGD, and preparing for the start of two additional Phase 2 studies in Lyme disease prevention and Rosacea. These milestones, along with our strengthened balance sheet, are important steps toward our goal of becoming a leading eye pharmaceutical company.”

Recent Business Highlights and Corporate Update
NDA submission of TP-03 for Demodex blepharitis (DB) expected this year
TP-03 met the primary and all secondary endpoints, resolved DB and was safe and well-tolerated in Saturn-2 Phase 3, the second and final pivotal trial
Initiated Ersa Phase 2a trial evaluating TP-03 for the treatment of Meibomian Gland Disease, another highly prevalent eyelid margin disease
Data from the Callisto Phase 1b trial of TP-05, a novel, oral, non-vaccine potential therapeutic for the prevention of Lyme disease, expected this year
Cash runway anticipated into at least 2026
$245 million of cash as of June 30, 2022, including Q2 2022 net proceeds of $74 million from follow-on equity raise and a $15 million milestone from China out-license
$30 million in expected milestones through 2024 from China out-license with $15 million in H2 2022

2022 Milestones
ProgramMilestoneAnticipated IndicationH1 2022H2 2022
TP-03Topline Pivotal Data (Saturn-2)
Demodex blepharitis
TP-03Initiate Phase 2 (Ersa)Meibomian Gland Disease
TP-05Initiate Ph2a (Carpo)Lyme disease prevention
TP-03NDA Submission
Demodex blepharitis
TP-04Initiate Phase 2 (Galatea)Rosacea
TP-05Phase 1b Data (Callisto)Lyme disease prevention
TP-03Initiate Phase 3 trial in China (with LianBio)
Demodex blepharitis

Second Quarter 2022 Financial Results

•    Second quarter net loss for 2022 was $5.7 million, compared to net income of $6.3 million for the same period in 2021

Second quarter 2022 license fee and collaboration revenue, as part of the strategic partnership with LianBio, was $15.3 million, compared to $22.0 million for the same period in 2021
•    Second quarter research and development expenses for 2022 were $9.6 million (inclusive of stock-based compensation of $1.0 million), compared to $7.2 million for the same period in 2021
•    Second quarter general and administrative expenses for 2022 were $10.4 million (inclusive of stock-based compensation of $2.5 million), compared to $6.8 million for the same period in 2021
•    As of June 30, 2022, cash and cash equivalents were $245.4 million

About Tarsus Pharmaceuticals, Inc.

Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus 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. Tarsus is studying two investigational medicines in clinical trials. Its lead product candidate, TP-03, is a novel therapeutic which has demonstrated positive results in two pivotal trials 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 potential approval and commercialization of TP-03, the initiation of Phase 2 studies for Lyme disease prevention and the treatment of rosacea, cash runway expectations, the terms of the license agreement 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, TP-04 and TP-05, the timing, objectives and results of the clinical trials, 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-04, 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, MGD, rosacea, Lyme disease prevention, 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, TP-04 for the treatment of Rosacea, as well as TP-05 for the prevention 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 and the most recent Form 10-Q quarterly filing filed 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:
Adrienne Kemp
Sr. Director, Corporate Communications
(949) 922-0801
Investor Contact:
David Nakasone
Head of Investor Relations
(949) 620-3223

(In thousands, except share and per share amounts)

 Three Months Ended
June 30,
Six Months Ended
June 30,
License fees$13,893 $19,048 $13,893 $52,359 
Collaboration revenue1,384 2,969 1,923 3,090 
Total revenues15,277 22,017 15,816 55,449 
Operating expenses:
Cost of license fees and collaboration revenue522 737 555 2,034 
Research and development9,603 7,204 21,684 23,465 
General and administrative10,376 6,794 18,322 11,954 
Total operating expenses20,501 14,735 40,561 37,453 
(Loss) income from operations before other (expense) income and income taxes(5,224)7,282 (24,745)17,996 
Other (expense) income:
Interest (expense) income, net (247)(563)16 
Other income (expense), net106 (39)143 (73)
Unrealized loss on equity investments(121)— (313)— 
Change in fair value of equity warrants issued by licensee(257)(876)(502)(876)
Total other expense, net (519)(908)(1,235)(933)
Provision for income taxes— (29)(1)(342)
Net (loss) income and comprehensive (loss) income$(5,743)$6,345 $(25,981)$16,721 
Net (loss) income per share, basic$(0.24)$0.31 $(1.15)$0.81 
Net (loss) income per share, diluted$(0.24)$0.29 $(1.15)$0.76 
Weighted-average shares outstanding, basic24,332,531 20,555,258 22,531,384 20,446,246 
Weighted-average shares outstanding, diluted24,332,531 21,966,599 22,531,384 21,895,304 

(In thousands, except share and par value amounts)
June 30, 2022December 31, 2021
Current assets:
Cash and cash equivalents$245,363 $171,332 
Marketable securities— 483 
Accounts receivable17 — 
Other receivables603 92 
Prepaid expenses and other current assets4,300 4,045 
Total current assets250,283 175,952 
Property and equipment, net963 755 
Operating lease right-of-use assets813 1,074 
Long-term investments169 — 
Other assets600 1,126 
Total assets$252,828 $178,907 
Current liabilities:
Accounts payable and other accrued liabilities$8,938 $8,680 
Accrued payroll and benefits2,780 2,798 
Total current liabilities11,718 11,478 
Term loan, net19,262 — 
Other long-term liabilities343 699 
Total liabilities31,323 12,177 
Commitments and contingencies
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; 26,650,078 shares issued and 26,644,252 outstanding, which excludes 5,826 shares subject to repurchase at June 30, 2022 (unaudited); 20,726,580 shares issued and 20,698,737 outstanding, which excludes 27,840 shares subject to repurchase at December 31, 2021
Additional paid-in capital294,153 213,398 
Accumulated deficit(72,653)(46,672)
Total stockholders’ equity221,505 166,730 
Total liabilities and stockholders’ equity$252,828 $178,907