UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (date of earliest event reported): December 11, 2023
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(Exact name of registrant as specified in its charter)
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Securities registered pursuant to Section 12(b) of the Act:
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The Nasdaq Stock Market LLC | ||||||||
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 8.01 Other Events.
On December 11, 2023, Tarsus Pharmaceuticals, Inc. (the “Company”) announced positive topline results of the Company’s Ersa Phase 2a clinical trial evaluating TP-03 (lotilaner ophthalmic solution, 0.25%) administered twice daily (BID) or three times a day (TID) for 12 weeks for the treatment of Meibomian Gland Disease (MGD) in patients with Demodex mites. A corporate presentation which includes a summary of the topline clinical results of the Ersa trial is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | Description | |||||||||||||||||||||||||
99.1 | ||||||||||||||||||||||||||
| 104 | Cover Page Interactive Data File (embedded within XBRL document) | |||||||||||||||||||||||||
SIGNATURES
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.
| TARSUS PHARMACEUTICALS, INC. | |||||||||||||||||||||||
| Date: | December 11, 2023 | /s/ Jeffrey S. Farrow | |||||||||||||||||||||
| Jeffrey S. Farrow | |||||||||||||||||||||||
| Chief Financial Officer and Chief Strategy Officer | |||||||||||||||||||||||
| (Principal Financial Officer and Principal Accounting Officer) | |||||||||||||||||||||||
Ersa Phase 2a Study Evaluating TP-03 for the Treatment of MGD in Patients with Demodex Mites Topline Data Presentation December 2023
Legal Disclaimer This presentation contains forward-looking statements that involve risks and uncertainties. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current expectations about future events that we believe may affect our financial condition, results of operations, business strategy, and financial needs. All statements other than statements of historical facts contained in this presentation, including any statements regarding the timing, objectives, and results of the clinical trials including the complete clinical results of the Ersa trial and anticipated regulatory and development milestones are forward-looking statements. The words “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “potential,” “continue” and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Important factors that could cause our actual results to differ materially are detailed from time to time in the reports we file with the Securities and Exchange Commission, copies of which are posted on our website and are available from us 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. © Tarsus Pharmaceuticals – For Investor Purposes Only2
Ersa Phase 2a Study Evaluating TP-03 for the Treatment of Meibomian Gland Disease in Patients with Demodex Mites • TP-03 (lotilaner ophthalmic solution 0.25%) demonstrated statistically significant improvements compared to baseline in objective measures of meibomian gland function at 6 and 12 weeks – Meibomian gland secretion score (MGSS) at Day 43 (6 weeks) and Day 85 (12 weeks) demonstrated a statistically significant and clinically meaningful improvement over baseline – Number of glands secreting clear meibum demonstrated statistically significant and clinically meaningful improvement from baseline to Day 43 and 85 – There were no significant differences between BID and TID across all measures • Collarette cure and lid margin erythema cure demonstrated statistically significant improvement consistent with prior TP-03 studies • TP-03 was generally well-tolerated • FDA discussion planned for 2024 3 © Tarsus Pharmaceuticals – For Investor Purposes Only
Ersa Phase 2a Study Overview • Randomized, Double-Masked, Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens (BID vs TID) of TP-03 for the Treatment of MGD in Patients with Demodex mites • 39 patients randomized to BID/TID arms • Endpoints collected included safety assessments, meibomian gland function, DB endpoints and patient-reported symptoms 4 40 subjects (39 completed) TID TP-03, 0.25% BID TP-03, 0.25% Rand 1:1 Day 1 Day 1 Day 15 (± 4 days) Day 15 (± 4 days) Day 29 (± 5 days) Day 29 (± 5 days) Day 43 (-7/+6 days) Day 43 (-7/+6 days) Day 57 (-7/+10 days) Day 57 (-7/+10 days) Day 85 (-13/+7 days) Day 85 (-13/+7 days) Day 115 (+60 days) Day 115 (+60 days) TREATMENT PERIOD FOLLOW-UP © Tarsus Pharmaceuticals – For Investor Purposes Only
TP-03 Treatment Significantly Improves Meibomian Gland Function • Demonstrated a significant and clinically meaningful increase from baseline that was observed in the mean MGSS of 10.5 (± 1.6 standard error, SE) and 11.7 (± 1.9 SE) for the BID and TID arms, respectively, at Day 85 (p < 0.001) • No statistically significant differences between BID and TID treatment groups 5 21.8 28.1 32.7 22.1 27.6 33.8 0 5 10 15 20 25 30 35 40 Baseline (N=21/18) Day 43 (N=20/18) Day 85 (N=20/18) Mean (± SE) MGSS Score* BID TID p<0.001 p<0.001 *MGSS Score Range 0-45© Tarsus Pharmaceuticals – For Investor Purposes Only
TP-03 Treatment Significantly Improves Meibomian Gland Secretion • Demonstrated improvement in the mean number of meibomian glands secreting clear liquid from baseline that was also statistically significant and clinically meaningful, with an increase of 4.8 (± 0.8 SE) and 5.3 (± 1.1 SE) glands for the BID and TID arms, respectively, at Day 85 (p < 0.001) • No statistically significant differences between BID and TID treatment groups 6 M ea n # of g la nd s 0.6 2.9 5.5 0.9 3 6.3 0 1 2 3 4 5 6 7 8 Baseline (N=21/18) Day 43 (N=20/18) Day 85 (N=20/18) Mean (± SE) Number of Glands with Clear Meibum (Score = 3) BID TID p<0.001 p<0.001 © Tarsus Pharmaceuticals – For Investor Purposes Only
Ersa MGD Phase 2a Study Safety and Tolerability • TP-03 was generally well tolerated following 12 week of treatment period – Most Adverse Events (AEs) were mild • 2 Drug-related AEs were mild (5.1%): 1 case of ocular discomfort in the BID arm and 1 case of conjunctivitis in the TID arm • No related Serious Adverse Events (SAEs) – 1 unrelated SAE of presyncope • No treatment-related discontinuations 7 © Tarsus Pharmaceuticals – For Investor Purposes Only