Tick-Borne Diseases

Generated $78.3 million in net product sales of XDEMVY®, an increase of 217% year over year and 18% over Q4 2024, and dispensed approximately 72,000 bottles to patients Strengthened financial position with approximately $135 million raised in public equity offering; cash, cash equivalents and marketable securities of approximately $408 million as of March 31, 2025 On-track to initiate a Phase 2 trial of TP-04 (lotilaner ophthalmic gel) for the potential treatment of Ocular Rosacea in H2 2025 Management to host conference call today, May 1, 2025, at 1:30 p.m. P.T. / 4:30 p.m. E.T. IRVINE, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced financial results for the first quarter ended March 31, 2025. “Tarsus has entered 2025 with incredible momentum, driven by strong execution of our category-creating strategic blueprint for success and a focused commitment to leadership in eye care. The XDEMVY launch is continuing to exceed our expectations and is on track to potentially become one of the best-selling anterior segment medicines,” said Bobak Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus. “Building on a foundation of strong commercial performance and the success of our recent equity offering, we believe we are well positioned to accelerate the growth of XDEMVY, create another new category in Ocular Rosacea and continue to advance our pipeline.” Recent Business and Clinical Highlights XDEMVY is on track to potentially be one of the fastest growing and best-selling anterior segment medicines. In the first quarter, the Company: Generated $78.3 million in XDEMVY net product sales, an increase of 217% year over year and 18% over Q4 2024. Dispensed approximately 72,000 bottles of XDEMVY to patients, an increase of 23% over Q4 2024. Broad commercial, Medicare and Medicaid reimbursement of XDEMVY now extends to more than 90% of covered lives. Recognized a gross-to-net discount of approximately 47%. Substantially increased the depth of prescribing among our target Eye Care Professionals (ECPs). At the end of Q1 2025, the number of ECPs writing more than one prescription per week increased by nearly 110% compared to Q3 2024. Direct-To-Consumer (DTC) advertising drove a 140% increase in the average weekly website visits in March 2025 compared to December 2024. Ongoing investment expected to increase alongside leading indicators of utilization. Presented new data showing the global prevalence and real-world patient burden of Demodex blepharitis (DB). The Elara study showed the high prevalence and significant impact of DB in Japan, consistent with the U.S. Results of the Orion registry showed XDEMVY-treated patients experienced meaningful improvements in some of the most impactful symptoms of disease, including fluctuating vision, redness, itchy eyelids, burning or stinging, dryness and crusted eyes. The combined data from the Ersa and Rhea studies in DB patients with Meibomian Gland Disease (MGD) showed statistically significant and clinically meaningful improvements of the meibomian glands, with at least three times more glands secreting normal or clear liquid in XDEMVY-treated patients compared to vehicle at day 43. Strengthened financial position with a $134.8 million upsized public equity offering which will continue to fund the launch of XDEMVY and ongoing pipeline investment. Continued to advance a robust pipeline with multiple catalysts expected in 2025. On-track to initiate a Phase 2 study of TP-04 (lotilaner ophthalmic gel) for Ocular Rosacea, a highly prevalent and underserved eye disease with no FDA-approved therapy, in H2 2025. Anticipated to meet with regulatory authorities in Japan in H2 2025 to help determine a regulatory path forward for XDEMVY in Japan. On-track for potential European regulatory approval in 2027 of a preservative-free formulation of XDEMVY. On-track to initiate a Phase 2 study of TP-05 (an investigational oral tablet) for the potential prevention of Lyme disease in 2026. Generated $78.3 million in XDEMVY net product sales, an increase of 217% year over year and 18% over Q4 2024. Dispensed approximately 72,000 bottles of XDEMVY to patients, an increase of 23% over Q4 2024. Recognized a gross-to-net discount of approximately 47%. At the end of Q1 2025, the number of ECPs writing more than one prescription per week increased by nearly 110% compared to Q3 2024. Ongoing investment expected to increase alongside leading indicators of utilization. The Elara study showed the high prevalence and significant impact of DB in Japan, consistent with the U.S. Results of the Orion registry showed XDEMVY-treated patients experienced meaningful improvements in some of the most impactful symptoms of disease, including fluctuating vision, redness, itchy eyelids, burning or stinging, dryness and crusted eyes. The combined data from the Ersa and Rhea studies in DB patients with Meibomian Gland Disease (MGD) showed statistically significant and clinically meaningful improvements of the meibomian glands, with at least three times more glands secreting normal or clear liquid in XDEMVY-treated patients compared to vehicle at day 43. On-track to initiate a Phase 2 study of TP-04 (lotilaner ophthalmic gel) for Ocular Rosacea, a highly prevalent and underserved eye disease with no FDA-approved therapy, in H2 2025. Anticipated to meet with regulatory authorities in Japan in H2 2025 to help determine a regulatory path forward for XDEMVY in Japan. On-track for potential European regulatory approval in 2027 of a preservative-free formulation of XDEMVY. On-track to initiate a Phase 2 study of TP-05 (an investigational oral tablet) for the potential prevention of Lyme disease in 2026. First Quarter 2025 Financial Results Product sales, net: were $78.3 million compared to $24.7 million for the same period in 2024, driven by approximately 72,000 bottles of XDEMVY delivered to patients compared to approximately 26,000 bottles delivered in the prior year period. Cost of sales: were $5.2 million compared to $1.7 million for the same period in 2024, due to manufacturing costs incurred after the approval of XDEMVY, the royalty we pay on net product sales, and the amortization of the milestones paid to our licensor, which is being amortized over its remaining useful life of 8.4 years. Research and development (R&D) expenses: were $14.4 million compared to $12.1 million for the same period in 2024. The increase was primarily due to $0.5 million of increased TP-04 program expenses, $0.9 million of increased payroll and personnel-related costs, $0.9 million of increased early-stage programs, and $0.3 million of increased other indirect expenses. These increases were partially offset by $0.4 million of decreased TP-03 program expenses. Total R&D non-cash stock compensation expense was $1.5 million, which was consistent with $1.5 million in the same period in 2024. Selling, general and administrative (SG&A) expenses: were $85.0 million compared to $51.6 million for the same period in 2024. The increase was due primarily to $9.6 million of increased payroll and personnel-related costs (including non-cash stock-based compensation), and $25.6 million of increased commercial and marketing costs, including direct-to-consumer advertising costs, as we continued our commercial expansion of XDEMVY. These increases were partially offset by $1.9 million of decreased information technology applications, legal, professional and other corporate expenses. Total SG&A non-cash stock compensation expense was $5.3 million, compared with $3.9 million in the same period in 2024. Net loss: was $25.1 million, compared to $35.7 million for the same period in 2024. Basic and diluted net loss per share for the quarter ended March 31, 2025 was $(0.64), compared with $(1.01) for the same period in 2024. Cash position: As of March 31, 2025, cash, cash equivalents and marketable securities were $407.9 million. Conference Call and WebcastTarsus will host a conference call and webcast to discuss its first quarter 2025 financial results and business highlights today, May 1, 2025, at 1:30 p.m. P.T. / 4:30 p.m. ET. A live webcast will be available on the events section of the Tarsus website. A recorded version of the call will be available on the website shortly after the completion of the call and will be archived there for at least 90 days. About XDEMVY® XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop designed to treat Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found the XDEMVY eye drop to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis. XDEMVY Indication and Important Safety Information INDICATIONS AND USAGEXDEMVY is indicated for the treatment of Demodex blepharitis. Most common side effects: The most common side effect in clinical trials was stinging and burning in 10% of patients. Other side effects in less than 2% of patients were chalazion/hordeolum and punctate keratitis. For additional information, please see full prescribing information available at: https://xdemvy.com/. About TP-03TP-03 (lotilaner ophthalmic solution) 0.25% is a novel therapeutic designed to treat Demodex blepharitis by targeting and eradicating the root cause of disease – Demodex mite infestation. It was approved by the FDA in 2023 under the brand name XDEMVY® for the treatment of Demodex blepharitis. Lotilaner is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific gamma-aminobutyric acid-gated chloride (GABA-Cl) channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eye lash follicles where the mites reside. About TP-04TP-04 is an investigational aqueous gel formulation of lotilaner, a well-characterized anti-parasitic agent that paralyzes and kills mites by selectively inhibiting parasite-specific GABA-Cl channels. Tarsus is studying TP-04 for the treatment of Ocular Rosacea (OR). About TP-05TP-05 is an investigational oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-Cl channels. TP-05 is believed to be the only non-vaccine, drug-based, preventative therapeutic in development designed to kill ticks to potentially prevent Lyme disease transmission. 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. XDEMVY (lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-04 for the potential treatment of Ocular Rosacea and TP-05 as an oral tablet for the prevention of Lyme disease, all of which are in Phase 2. 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 potential commercial success and growth of XDEMVY in Demodex blepharitis, including market size, acceptance, demand, prescription fill rate and adoption rate for XDEMVY; our ability to successfully implement and continue our new direct-to-consumer campaign; our ability to achieve and maintain distribution and patient access for XDEMVY and timing and breadth of payer coverage; our ability to continue to educate the market about Demodex blepharitis; our ability to initiate planned clinical studies; anticipated regulatory and development milestones including potential Europe and Japan regulatory pathways and approval for XDEMVY; the results of our clinical studies; the test results of our pipeline formulations; our ability to continue investing in our business, 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 is heavily dependent on the successful commercialization of its lead product, XDEMVY for the treatment of Demodex blepharitis and the development and regulatory approval and commercialization of its current and future product candidates; Tarsus’ ability to obtain and maintain regulatory approval for and successfully commercialize its products, including XDEMVY for the treatment of Demodex blepharitis, and its product candidates to meet existing and future regulatory standards; 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’ capital requirements are difficult to predict and may change; Tarsus may need to obtain additional funding to achieve its goals and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force Tarsus to delay, reduce, or eliminate its product development programs, commercialization efforts or other operations; Tarsus may not be successful in educating healthcare professionals and the market about the need for treatments specifically for Demodex blepharitis and other diseases targeted by XDEMVY or our product candidates; the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus expects to expand its development, regulatory, operational, sales, and marketing capabilities and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for XDEMVY and Tarsus’ product candidates, particularly TP-04 for the treatment of Ocular 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; 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; and if Tarsus is unable to access capital (including but not limited to cash, cash equivalents, and credit facilities) and/or loses capital, as a result of potential failure of any financial institutions that Tarsus does business with directly or indirectly. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statements 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, 2024 filed on February 25, 2025 and the most recent Form 10-Q quarterly filing filed with the SEC on May 1, 2025, 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 earnings 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.

In a survey representative of the general U.S. adult population, 1.26 percent of respondents – equivalent to about 3 million people – reported having received a medical diagnosis of babesiosis during their life-time; CDC data imply only about 73,000 people in that category.At the time they replied to the survey, 3.7 percent of respondents – equivalent to about 9.9 million people – reported they had been experiencing fatigue, a common symptom of babesiosis, for six months or longer. WASHINGTON, April 22, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced findings that the actual burden of babesiosis in the United States (U.S.) may be significantly higher than Centers for Disease Control and Prevention (CDC) statistics suggest. Preliminary results of an online survey conducted by the Company showed that nearly 3 million Americans (1.26 percent of the adult population in 2020) may have received a babesiosis diagnosis from a medical practitioner in their lifetime. In contrast, CDC reports 1,834 cases of babesiosis in 2020. Even though this annual number relies on different methodologies and timeframes, and is not directly comparable to the Company’s estimates, the disparity suggests the possibility that babesiosis is significantly underdiagnosed or underreported in existing public health reporting data. The Company believes this may indicate a greater demand for effective treatment than suggested by current CDC statistics. The survey included responses from 6,000 participants selected to match the U.S. adult demographic distribution. Babesiosis is a serious, emerging tick-borne disease often found as a co-infection with Lyme disease. It may be life-threatening in immunocompromised and elderly individuals. An as yet untested medical hypothesis advanced by some prescribing physicians in the Lyme disease community is that persistent Babesia infection contributes to chronic fatigue and other problems. If this is true, millions of Americans with persistent fatigue, a common symptom of babesiosis, may be living with an undiagnosed but potentially treatable illness. The Company commissioned the survey as part of its goal to define the size of the commercial market for babesiosis treatment candidates now in development. It was conducted by Format Analytics, an independent market research agency. The online quantitative survey was conducted among a general adult population sample of 6,000 adults, with demographic variables (gender, age, ethnicity, income) matched to U.S. census data for optimal representation of the U.S. population. Babesiosis was reported as a diagnosed medical condition experienced by 1.26 percent of respondents, implying that 3 million Americans may have experienced babesiosis (1.26 percent of 268 million U.S. residents). Moreover, approximately 17 percent of babesiosis patients reported having experienced a duration of illness of six months or more, implying that at least 570,000 U.S. adults have experienced chronic disease (17 percent of 1.26 percent of 268 million U.S. adults). Another objective of the survey was to estimate what proportion of U.S. residents are currently experiencing fatigue lasting longer than six months (inclusive of those who have received a formal diagnosis of chronic fatigue syndrome/encephalomyelitis). Approximately 3.7 percent of respondents to the survey, equivalent to about 9.9 million Americans per a U.S. adult population of 268 million U.S. adults, reported experiencing chronic fatigue of six months or longer at the time the survey was conducted. Approximately 56 percent of them (representing about 1.9 percent of total respondents) reported having received a formal diagnosis of Chronic Fatigue Syndrome (CFS). In contrast, in a 2021/2022 telephone survey, the CDC found that approximately 1.3 percent of respondents had received a formal diagnosis of CFS. “These survey results, which will be submitted for publication soon, suggest that official statistics may not capture the lived experiences of babesiosis patients in the U.S.,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Geoffrey Dow. “Infectious disease specialists seeking to treat patients who present with unexplained chronic fatigue should consider babesiosis as a differential diagnosis.” About Babesiosis and ARAKODA® Babesiosis is a rapidly emerging tick-borne disease often found as a co-infection with Lyme disease. Based on Lyme disease insurance claims and Babesia co-infection rates, 60 Degrees surmises that approximately 46,000 Americans are diagnosed with acute (short-term) babesiosis each year. Most people recover within 90 days when treated with standard antimicrobials recommended by the Infectious Diseases Society of America. These treatments are assumed to reduce the number of parasites enough for the immune system to clear the rest. However, in some individuals, Babesia infection may persist for at least a year, or they might recover and then feel unwell again up to two years later. Fatigue is usually the last clinical symptom of babesiosis to resolve. The actual number of people living with chronic or persistent (long-term) Babesia infection in the U.S. has not been described in the scientific literature. Medical literature suggests that ARAKODA (tafenoquine), a medicine licensed and manufactured by 60 Degrees may have the potential to clear Babesia parasites and ease symptoms. The Company is currently running two clinical trials (NCT06207370 and NCT06478641) to confirm these findings. A third study is being planned for people with a presumptive diagnosis of babesiosis and experiencing severe and disabling chronic fatigue (NCT06656351). One of the hypotheses the study will test is that 20 percent of patients entering the study will have a Babesia infection confirmable using commercially available molecular tests. ARAKODA is approved for malaria prophylaxis in the United States under the product name ARAKODA®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months. ARAKODA has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the U.S. Food and Drug Administration (FDA) for such an indication. About 60 Degrees Pharmaceuticals, Inc.60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals, Inc. achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention, in 2018. 60 Degrees also collaborates with prominent research organizations in the U.S., Australia, and Singapore. The 60 Degrees Pharmaceuticals mission has been supported through in-kind funding from the U.S. Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com. The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements. Cautionary Note Regarding Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on March 27, 2025, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Media Contacts:Sheila A. BurkeSheilaBurke-consultant@60degreespharma.com(484) 667-6330 Investor Contact:Patrick Gaynespatrickgaynes@60degreespharma

IRVINE, Calif., April 22, 2025 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) will present four distinct data sets highlighting the global prevalence and real-world patient burden of Demodex blepharitis, as well as the impact of XDEMVY® (lotilaner ophthalmic solution) 0.25% in addressing objective measures of disease at the American Society of Cataract and Refractive Surgery (ASCRS) 2025 Annual Meeting, taking place April 25-28, 2025, in Los Angeles, Calif. “From new prevalence data in Japan to real-world results in the US, the findings accepted for oral presentation at ASCRS reinforce the global burden of Demodex blepharitis and the potential of XDEMVY to deliver significant improvements in patient outcomes across multiple subtypes, including those with concomitant meibomian gland disease,” said Elizabeth Yeu, M.D., Chief Medical Officer of Tarsus. “We look forward to continuing to generate new evidence to advance the clinical understanding of XDEMVY and its potential impact on this highly prevalent eyelid disease and on the lives of patients.” Accepted abstracts include: Longitudinal Evaluation of Disease Burden and Treatment Efficacy in Patients with Demodex blepharitis: Orion Registry Interim Results Date: Sunday, April 27, 2025, 10:42 – 10:47 a.m. PT Location: Los Angeles Convention Center (LACC) – Level 2, 512 Presenter: Kendall E. Donaldson, M.D., M.S., ABO A real-world, multi-center study characterizing the burden of Demodex blepharitis, the current disease management landscape and key changes in patient outcomes after initiation of treatment with XDEMVY. Assessment of the Demodex Blepharitis Specific Symptoms: The Janus Study Date: Monday, April 28, 2025, 8:00 – 8:05 a.m. PT Location: LACC – Level 2, 506 Presenter: Nicole R. Fram, M.D., ABO A prospective, observational study that compared symptoms and clinical outcomes in patients with Demodex blepharitis to patients without Demodex blepharitis. Lotilaner Ophthalmic Solution, 0.25% for the Treatment of Demodex blepharitis Patients with Meibomian Gland Dysfunction Date: Monday, April 28, 2025, 8:33 – 8:38 a.m. PT Location: LACC – Level 2, 506 Presenter: Mitchell C. Schultz, M.D., ABO Two pooled studies that evaluated the safety and efficacy of XDEMVY in patients with Demodex blepharitis and Meibomian Gland Disease. Prevalence of Demodex blepharitis in Japan: The Elara Study Date: Monday, April 28, 2025, 10:30 – 10:35 a.m. PT Location: LACC – Level 2, 504 Presenter: Shizuka Koh, M.D., Ph.D. An observational, multicenter study highlighting the prevalence and symptomatology of Demodex blepharitis in Japan. About 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 U.S. eye care clinics have collarettes, a pathognomonic sign of Demodex mite infestation, and that at least 45 million people annually visit an eye care clinic. Demodex blepharitis can have a significant clinical burden and negative impact on patients’ daily lives. About XDEMVY® XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop designed to treat Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found the XDEMVY eye drop to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis. XDEMVY Indication and Important Safety Information Indications and Usage XDEMVY (lotilaner ophthalmic solution) 0.25% is indicated for the treatment of Demodex blepharitis. Important Safety Information Most common side effects: The most common side effect in clinical trials was stinging and burning in 10% of patients. Other side effects in less than 2% of patients were chalazion/hordeolum and punctate keratitis. Handling the Container: Avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. When to Seek Physician Advice: Immediately seek a physician’s advice concerning the continued use of XDEMVY if you develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions. Use with Contact Lenses: XDEMVY contains potassium sorbate, which may discolor soft contact lenses. Contact lenses should be removed prior to instillation of XDEMVY and may be reinserted 15 minutes following its administration. To report SUSPECTED ADVERSE REACTIONS, contact Tarsus Pharmaceuticals at 1-888-421-4002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For additional information please see Full Prescribing Information available at: www.xdemvy.com. 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 and infectious disease prevention. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-04 for the potential treatment of Ocular Rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease. 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 timing, content, location, and presenters of scientific abstracts at an upcoming medical conference, our ability to continue to educate the market and generate data about Demodex blepharitis, the potential market size of Demodex blepharitis globally, 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. 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, 2024, filed on February 25, 2025, with the SEC, 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: Adrienne Kemp Sr. Director, Corporate Communications (949) 922-0801 akemp@tarsusrx.com Investor Contact: David Nakasone Head of Investor Relations (949) 620-3223 DNakasone@tarsusrx.com