Tarsus Completes Enrollment for the Pivotal Phase 3 Saturn-2 Trial of TP-03 to Treat Demodex Blepharitis & Secures $175 Million Credit Facility

Tarsus Pharmaceuticals, Inc. recently 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).

“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, MD, PhD, 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.

“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.

TP-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.

Blepharitis 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 US 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.

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.