TARS Tarsus Pharmaceuticals Inc.

25
-2.7  -10%
Previous Close 27.7
Open 27.04
52 Week Low 19.67
52 Week High 63.69
Market Cap $516,924,800
Shares 20,676,992
Float 8,947,664
Enterprise Value $391,278,678
Volume 41,633
Av. Daily Volume 31,428
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Upcoming Catalysts

Drug Stage Catalyst Date
TP-03 - Saturn-2
Demodex Blepharitis
Phase 3
Phase 3
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TP-05
Healthy volunteers / Lyme disease
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
TP-03 - Saturn-1
Demodex Blepharitis
Phase 2/3
Phase 2/3
Phase 2b/3 top-line data released June 21, 2021. Endpoints met noted November 4, 2021.

Latest News

  1. IRVINE, Calif., Nov. 23, 2021 (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 patients, starting with eye care, today announced that management will participate in the following virtual investor conferences:

    • Ophthalmology Day at BTIG on Tuesday, November 30, 2021
    • Piper Sandler 33rd Annual Virtual Healthcare Conference on December 1-2, 2021

    The above listed dates are subject to change. Please check www.tarsusrx.com for the latest information.

    About Tarsus Pharmaceuticals, Inc.

    Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care…

    IRVINE, Calif., Nov. 23, 2021 (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 patients, starting with eye care, today announced that management will participate in the following virtual investor conferences:

    • Ophthalmology Day at BTIG on Tuesday, November 30, 2021
    • Piper Sandler 33rd Annual Virtual Healthcare Conference on December 1-2, 2021

    The above listed dates are subject to change. Please check www.tarsusrx.com for the latest information.

    About Tarsus Pharmaceuticals, Inc.

    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 1 clinical trial.

    Contacts:

    Media Contact:

    SuJin Oh

    Shop PR

    (917) 841-5213

    Investor Contact:

    David Nakasone

    Head of Investor Relations

    (949) 620-3223



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  2. IRVINE, Calif., Nov. 10, 2021 (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 patients, starting with eye care, today announced that Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus will participate in a fireside chat at the Virtual Jefferies London Healthcare Conference.

    Fireside Chat Presentation Details

    • The fireside chat will be available on-demand beginning Thursday, November 18th at 8:00am GT / 12:00am PT through Friday, November 19th

    Management will also host virtual one-on-one meetings on November 19, 2021. For additional information or to schedule a meeting, please contact…

    IRVINE, Calif., Nov. 10, 2021 (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 patients, starting with eye care, today announced that Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus will participate in a fireside chat at the Virtual Jefferies London Healthcare Conference.

    Fireside Chat Presentation Details

    • The fireside chat will be available on-demand beginning Thursday, November 18th at 8:00am GT / 12:00am PT through Friday, November 19th

    Management will also host virtual one-on-one meetings on November 19, 2021. For additional information or to schedule a meeting, please contact your Jefferies representative.

    The above listed dates are subject to change. Details on the presentation time or changes to the presentation date can be found on the Company's website. Please check www.tarsusrx.com for the latest information.

    A live webcast of the presentation will also be available on the events section of the Tarsus website. The replay will be available within 48 hours and will be archived for a limited time.

    About Tarsus Pharmaceuticals, Inc.

    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 1 clinical trial.

    Contacts:

    Media Contact:

    SuJin Oh

    Shop PR

    (917) 841-5213

    Investor Contact:

    David Nakasone

    Head of Investor Relations

    (949) 620-3223

     



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  3. On track to complete enrollment in the fourth quarter of 2021 for the Saturn-2 Phase 3, the second pivotal trial of TP-03 for the treatment of Demodex blepharitis; topline data expected in the first quarter of 2022

    Data from two pioneering studies on prevalence and impact of Demodex blepharitis were presented November 4th at the American Academy of Optometry 2021 Annual Meeting

    Continued to advance the Callisto Phase 1 trial of TP-05, a novel, oral, non-vaccine therapeutic for the prevention of Lyme disease with data expected in the first half of 2022

    Cash and equivalents of $184 million as of September 30, 2021, for expected runway into the second half of 2023

    IRVINE, Calif., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc…

    On track to complete enrollment in the fourth quarter of 2021 for the Saturn-2 Phase 3, the second pivotal trial of TP-03 for the treatment of Demodex blepharitis; topline data expected in the first quarter of 2022

    Data from two pioneering studies on prevalence and impact of Demodex blepharitis were presented November 4th at the American Academy of Optometry 2021 Annual Meeting

    Continued to advance the Callisto Phase 1 trial of TP-05, a novel, oral, non-vaccine therapeutic for the prevention of Lyme disease with data expected in the first half of 2022

    Cash and equivalents of $184 million as of September 30, 2021, for expected runway into the second half of 2023

    IRVINE, Calif., Nov. 09, 2021 (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 patients, today announced financial results for the third quarter ended September 30, 2021 and recent business achievements.

    "We are delighted with the progress we are making on our strategic objectives, including advancing our pipeline and commercial plan. We are on track to complete enrollment in Saturn-2, our second pivotal trial for TP-03, by year end. Additionally, our recently presented new data from Titan and Atlas further reinforces the large unmet market and impact Demodex blepharitis has on patients already seeing their eye doctor for common ocular conditions," said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. "Looking ahead, we expect significant advancements in our pipeline, including initiating TP-03 for Meibomian Gland Disease and TP-04 for rosacea in the first half of 2022. Additionally, we expect to complete the Phase 1 trial of TP-05 for the prevention of Lyme disease and conduct further FDA discussions in the first half of 2022."

    Recent Business Highlights and Corporate Update:

    • On track to complete enrollment by year end 2021 in Saturn-2, our second pivotal trial of TP-03, a potential pioneering therapeutic for Demodex blepharitis
      • Saturn-2 is expected to enroll 418 participants across 15-20 sites in the U.S.
      • The trial is designed to evaluate the same primary and secondary endpoints as the pivotal Saturn-1 trial in which TP-03 met the primary and secondary endpoints
      • Pivotal topline data continues to be expected in Q1 2022, which if positive, will be followed by a NDA submission in 2022

         
    • Presented additional data from the Saturn-1 Phase 2b/3 pivotal trial at the American Society of Cataract and Refractive Surgery 2021 Annual Meeting demonstrating high treatment response rates reinforcing the potential of TP-03 to be the standard of care for Demodex blepharitis patients
      • 95% of TP-03 patients showed a significant improvement in mite count, achieving ≤0.5 mites per lash
      • 93% of TP-03 patients improved by at least one collarette grade

         
    • Presented data from Titan and Atlas, two pioneering studies on the prevalence and impact of Demodex blepharitis respectively, at the American Academy of Optometry 2021 Annual Meeting
      • New Titan real-world prevalence data:
        • Demodex blepharitis accounts for over two-thirds of blepharitis cases and is also highly prevalent in many commonly seen patient groups, including dry eye, contact lens and cataracts
        • 75% of patients using tea tree oils and 57% of those using lid wipes were found to have a high prevalence of collarettes, indicating that current management tools for this disease are largely ineffective
      • The Atlas study, an observational study to evaluate the functional and psychosocial impact of Demodex blepharitis and clinical manifestations, showed that Demodex blepharitis is associated with a significant symptomatic and psychosocial burden, negatively affecting daily life in 80% of patients

         
    • Continued to advance the Callisto Phase 1 trial evaluating TP-05, a novel, oral, non-vaccine therapeutic, for the prevention of Lyme disease with data expected in the first half of 2022
      • Callisto is a single and multiple ascending dose trial to evaluate safety, tolerability and pharmacokinetics of TP-05 in healthy volunteers
      • There are approximately 80 million people in the U.S. at risk of Lyme disease exposure, more than 30 million of which are at moderate to high risk, which can result in severe neurological and other debilitating symptoms

         
    • Appointed healthcare industry leader, Rosemary A. Crane, to our Board of Directors
      • Ms. Crane serves as the Chair of our newly created Science and Technology Committee, focused on external and internal innovation and pipeline opportunities
      • She has more than 30 years of extensive experience in the pharmaceutical industry, including executive leadership, board service, innovation, business development, operations, and global commercialization expertise

         
    • Received $20 million in proceeds as part of the partnership with LianBio for clinical milestones achieved in June 2021, continue to expect to earn an additional $15 million in clinical milestones in the first half of 2022 (for a total of $70 million of proceeds since agreement execution in March 2021)

    Third Quarter 2021 Financial Results

    • Third quarter net loss for 2021 was $15.7 million, compared to a net loss of $10.1 million for the same period in 2020 
    • Third quarter 2021 license fee and collaboration revenue, as part of our strategic partnership with LianBio, was $1.2 million; and $0.1 million in associated expense in proportion to this revenue
    • Third quarter research and development expenses for 2021 were $10.2 million (inclusive of stock-based compensation of $0.5 million), compared to $8.0 million for the same period in 2020
    • Third quarter general and administrative expenses for 2021 increased to $6.7 million (inclusive of stock-based compensation of $1.6 million), compared to $2.2 million for the same period in 2020
    • As of September 30, 2021, cash and cash equivalents were $183.8 million

    About Tarsus Pharmaceuticals, Inc.

    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 1 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 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, 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-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, 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 on March 31, 2021 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: 
    SuJin Oh 
    Shop PR 
    (917) 841-5213 
     
      
    Investor Contact: 
    David Nakasone 
    Head of Investor Relations 
    (949) 620-3223 
     





    TARSUS PHARMACEUTICALS, INC.

    STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME

    (In thousands, except share and per share amounts)

    (unaudited)

     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
     2021 2020 2021 2020
    Revenues:       
    License fees$708      $53,067     
    Collaboration revenue532      3,622     
    Total revenues1,240      56,689     
    Operating expenses:       
    Cost of license fees and collaboration revenue65      2,099     
    Research and development10,209   7,991   33,674   11,239  
    General and administrative6,671   2,150   18,625   4,282  
    Total operating expenses16,945   10,141   54,398   15,521  
    (Loss) income from operations before other income (expense) and income taxes(15,705)  (10,141)  2,291   (15,521) 
    Other income (expense):       
    Interest income, net8   4   24   178  
    Other income (expense), net5      (68)    
    Change in fair value of equity warrant rights(346)     (1,222)    
    Total other (expense) income(333)  4   (1,266)  178  
    Benefit (provision) for income taxes341   (1)  (1)  (1) 
    Net (loss) income and comprehensive (loss) income$(15,697)  $(10,138)  $1,024   $(15,344) 
    Net (loss) income per share       
    Basic$(0.76)  $(3.71)  $0.05   $(5.73) 
    Diluted$(0.76)  $(3.71)  $0.05   $(5.73) 
    Weighted-average shares outstanding       
    Basic20,641,285   2,729,685   20,511,973   2,677,315  
    Diluted20,641,285   2,729,685   22,032,487   2,677,315  



    TARSUS PHARMACEUTICALS, INC.

    BALANCE SHEETS

    (In thousands, except share and par value amounts)

     September 30, 2021 December 31, 2020
     (unaudited)  
    Assets   
    Current assets:   
    Cash and cash equivalents$183,801   $168,129  
    Restricted cash   20  
    Other receivables139   20  
    Prepaid expenses and other current assets3,148   2,486  
    Total current assets187,088   170,655  
    Property and equipment, net of accumulated depreciation519   548  
    Operating lease right-of-use asset1,190   688  
    Other assets1,615   81  
    Total assets$190,412   $171,972  
    Liabilities and stockholders' equity   
    Current liabilities:   
    Accounts payable and other accrued liabilities$8,119   $4,347  
    Accrued payroll and benefits2,246   1,040  
    Total current liabilities10,365   5,387  
    Other long-term liabilities905   605  
    Total liabilities11,270   5,992  
    Commitments and contingencies   
    Stockholders' equity:   
    Preferred stock, $0.0001 par value; 10,000,000 authorized at September 30, 2021 and December 31, 2020; no shares issued and outstanding at September 30, 2021 and December 31, 2020     
    Common stock, $0.0001 par value; 200,000,000 shares authorized; 20,714,228 shares issued and 20,671,079 outstanding, which excludes 43,149 shares subject to repurchase at September 30, 2021; 20,502,576 shares issued and 20,323,301 outstanding, which excludes 179,375 shares subject to repurchase at December 31, 20204   4  
    Additional paid-in capital210,959   198,821  
    Accumulated deficit(31,821)  (32,845) 
    Total stockholders' equity179,142   165,980  
    Total liabilities and stockholders' equity$190,412   $171,972  

     



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  4. Titan real-world prevalence study data reveals that Demodex blepharitis accounts for over two-thirds of all blepharitis cases and is highly prevalent in many commonly seen patient groups

    New Titan study data analysis showed that current management tools, such as tea tree oil (TTO) and lid wipes, are ineffective at treating Demodex blepharitis

    Atlas disease impact study showed that Demodex blepharitis is associated with a significant symptomatic and psychosocial burden, negatively affecting daily life in 80% of patients

    IRVINE, Calif., Nov. 04, 2021 (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 patients, starting…

    Titan real-world prevalence study data reveals that Demodex blepharitis accounts for over two-thirds of all blepharitis cases and is highly prevalent in many commonly seen patient groups

    New Titan study data analysis showed that current management tools, such as tea tree oil (TTO) and lid wipes, are ineffective at treating Demodex blepharitis

    Atlas disease impact study showed that Demodex blepharitis is associated with a significant symptomatic and psychosocial burden, negatively affecting daily life in 80% of patients

    IRVINE, Calif., Nov. 04, 2021 (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 patients, starting with eye care, presented data today from two pioneering studies on the prevalence and impact of Demodex blepharitis at the American Academy of Optometry (AAOpt) 2021 Annual Meeting in Boston, MA, the largest optometry meeting in the U.S. The Titan real-world prevalence study data revealed that Demodex blepharitis accounts for over two-thirds (69%) of all blepharitis cases and is present in many commonly seen patient groups. Additionally, new data revealed a high prevalence of collarettes in patient populations using TTO (75%) and lid wipes (57%), indicating that current management tools for this disease are largely ineffective. There are currently no U.S. Food and Drug Administration (FDA) approved therapeutics for Demodex blepharitis. Tarsus' lead investigational candidate, TP-03 (lotilaner ophthalmic solution, 0.25%), is currently being evaluated in the Saturn-2, Phase 3, pivotal trial for the treatment of Demodex blepharitis. TP-03 was previously evaluated in the Saturn-1, Phase 2b/3, pivotal trial involving 421 patients. Saturn-1 showed that TP-03 cleared the signs of Demodex blepharitis, met all primary and secondary endpoints with no serious treatment-related adverse events and was well-tolerated. Results from the Saturn-2, Phase 3, pivotal trial are anticipated in Q1 of 2022.

    "Data from the Titan and Atlas studies provide optometrists with important insights into the prevalence and negative impact Demodex blepharitis can have on patients, as well as the limitations of current management tools," said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. "We know that optometrists are often on the frontlines of diagnosing this disease, as they are the first point of contact for many patients undergoing eye exams. We hope that sharing these findings will encourage them to continue to proactively identify the disease before it can have long-term negative impacts. These data also underscore the critical need for an effective solution for the treatment of this disease and we look forward to progressing the development of our of lead investigational candidate, TP-03, which – if FDA-approved – could become the standard of care for patients with Demodex blepharitis."

    New Titan Study Data

    The Titan study was an IRB-approved, retrospective chart review of 1,032 patients across six U.S.-based ophthalmology and optometry practices conducted by seven investigators. The study was designed to better understand the prevalence of Demodex blepharitis via collarettes in U.S. eye care clinics. Collarettes are a pathognomonic sign of Demodex blepharitis and are an accumulation of epithelial cells, keratin, mite waste product and eggs that form at the base of the eyelashes. The Titan study revealed that 58% of patients visiting eye care clinics for any reason had Demodex blepharitis, as evidenced by the presence of collarettes.

    The new Titan data analysis demonstrates that Demodex blepharitis accounts for over two-thirds (69%) of all blepharitis cases and is present in many commonly seen patient populations. The new analysis showed a high collarette prevalence among eye care patients with glaucoma (65%), those taking a dry eye prescription treatment (60%), those with cataracts (56%) and among contact lens users (51%). The data also showed a high prevalence of collarettes among patients using TTO (75%) and lid wipes (57%) to manage their disease. These new data demonstrate that commonly used eye care treatments, even those used to manage blepharitis, are not effective at treating Demodex blepharitis.

    "The Titan study demonstrates that Demodex blepharitis accounts for the majority of clinical blepharitis cases," said Paul Karpecki OD, FAAO, Director of Cornea Services at Kentucky Eye Institute in Lexington, KY and Associate Professor at the Kentucky College of Optometry in Pikeville, KY, and Titan study presenter. "Given the high collarette prevalence in many patient groups, it is important that all optometrists have patients look down during a standard slit lamp exam to check for the presence of collarettes on the eyelashes during each routine patient visit. I look forward to having a potential treatment option that can effectively provide relief for so many of my patients."

    Atlas Study Data

    The Atlas study was the first multi-center observational study to evaluate the impact of Demodex blepharitis. The study surveyed 311 patients who were pre-screened at eight sites participating in the pivotal Phase 2b/3 Saturn-1 trial evaluating the safety and efficacy of TP-03 in adults with Demodex blepharitis. Patients who had three objective signs of Demodex blepharitis, including the presence of Demodex mites, collarettes and lid margin redness, were asked questions about their ocular symptoms, diagnoses, and history, and their questionnaire responses were analyzed. The Atlas study showed that Demodex blepharitis is associated with a significant symptomatic and psychosocial burden, negatively affecting daily life in 80% of patients with the disease.

    The study found that the considerable burdens of Demodex blepharitis led patients to seek treatment and medical care, mostly unsuccessfully:

    • More than half of patients (51%) reported suffering from signs and symptoms of this disease for more than four years, having been to their eye doctor several times with no resolution, but most patients (58%) reported they had never been diagnosed with blepharitis.
    • The most common symptoms reported were itchy eyes (55%) and dry eyes (46%).
    • Many patients said they were emotionally affected – almost half (47%) reported being conscious of their eyes all day, nearly a quarter (23%) were constantly worried about their eyes and 23% said it gave their eyes or eyelids a negative appearance to others.
    • The study also showed that the disease affected daily activities – almost half (47%) reported difficulty driving at night, nearly a third (30%) said it added time to their daily hygiene routine, and 34% of women reported difficulty wearing makeup.

    About TP-03

    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. TP-03 is a topical ophthalmic formulation of lotilaner, which is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific GABA-Cl channels. It is a potent, non-competitive antagonist of insect and arachnid GABA-Cl channels and 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 met all primary and secondary endpoints with no serious treatment-related adverse events and was well tolerated. Prior to that, Tarsus also completed four Phase 2 clinical trials of TP-03 in Demodex blepharitis, all of which met their respective endpoints with no significant adverse events nor any events leading to treatment discontinuation. TP-03 is currently being evaluated in the Saturn-2 (Phase 3) pivotal trial. If approved, TP-03 may offer treatment for millions of patients around the world with Demodex blepharitis.

    About Demodex Blepharitis

    Blepharitis is a common ocular condition that is characterized by inflammation of the eyelid margin, redness and ocular irritation. Demodex blepharitis is caused by an infestation of Demodex mites, the most common ectoparasite found on humans. 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 infestation, and another published study estimating 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. Currently, there are no FDA-approved treatments for Demodex blepharitis.

    About Tarsus Pharmaceuticals, Inc.

    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 1 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 Tarsus' plans for and the anticipating benefits of its product candidates, including TP-03 and TP-05, the timing, objectives and results of the clinical trials and anticipated regulatory and development milestones, including the timing of the Saturn-2 clinical trial and submission of an NDA, 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 5, 2021, which Tarsus incorporates by reference into this press release and 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:

    SuJin Oh

    Shop PR

    (917) 841-5213

    Investor Contact:

    David Nakasone

    Head of Investor Relations

    (949) 620-3223



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  5. IRVINE, Calif., Nov. 02, 2021 (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 patients, starting with eye care, today announced that Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus will present a corporate update at the Virtual Credit Suisse 30th Annual Healthcare Conference.

    Presentation Details
    Date: Monday, November 8th
    Time: 11:40am PT / 2:40pm ET
    Webcast: Tarsus Credit Suisse Webcast

    The above listed date is subject to change. Details on the presentation time or changes to the presentation date can be found on the Company's website. Please check www.tarsusrx.com for the latest information…

    IRVINE, Calif., Nov. 02, 2021 (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 patients, starting with eye care, today announced that Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus will present a corporate update at the Virtual Credit Suisse 30th Annual Healthcare Conference.

    Presentation Details

    Date: Monday, November 8th

    Time: 11:40am PT / 2:40pm ET

    Webcast: Tarsus Credit Suisse Webcast

    The above listed date is subject to change. Details on the presentation time or changes to the presentation date can be found on the Company's website. Please check www.tarsusrx.com for the latest information.

    A live webcast of the presentation will also be available on the events section of the Tarsus website. The replay will be available within 48 hours and will be archived for a limited time.

    About Tarsus Pharmaceuticals, Inc.

    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 1 clinical trial.

    Contacts:

    Media Contact:

    SuJin Oh

    Shop PR

    (917) 841-5213

    Investor Contact:

    David Nakasone

    Head of Investor Relations

    (949) 620-3223



    Primary Logo

    View Full Article Hide Full Article
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