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aTyr Pharma, Inc.(ATYR) - 2025 Q1 - Quarterly Results
2025-05-07 20:03
Exhibit 99.1 IMMEDIATE RELEASE Contact: Ashlee Dunston Sr. Director, Investor Relations and Public Affairs adunston@atyrpharma.com aTyr Pharma Announces First Quarter 2025 Results and Provides Corporate Update Topline data from Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis on track for the third quarter of 2025. Blinded baseline demographics and disease characteristics from Phase 3 EFZO-FIT™ study and current U.S. epidemiology and treatment practices for pulmonary sarcoidosis to be present ...
aTyr Pharma Announces First Quarter 2025 Results and Provides Corporate Update
Globenewswire· 2025-05-07 20:01
Core Insights - aTyr Pharma is progressing with its clinical program for efzofitimod, a first-in-class biologic immunomodulator targeting pulmonary sarcoidosis, with topline data from the Phase 3 EFZO-FIT™ study expected in Q3 2025 [1][4][3] Company Updates - The first quarter of 2025 saw aTyr Pharma report a net loss of $14.88 million, compared to a loss of $15.49 million in the same period of 2024, with total revenues remaining at $0 [13] - Research and development expenses for Q1 2025 were $11.8 million, primarily for clinical trial costs related to the EFZO-FIT™ and EFZO-CONNECT™ studies [10][13] - The company appointed Dalia R. Rayes as Head of Commercial for the Global Efzofitimod Franchise, bringing over 25 years of experience in biotechnology and pharmaceutical commercial organizations [4] Clinical Trials - The Phase 3 EFZO-FIT™ study is a randomized, double-blind, placebo-controlled trial involving 268 patients across 85 centers in nine countries, focusing on steroid reduction as the primary endpoint [4][7] - The ongoing Phase 2 EFZO-CONNECT™ study aims to evaluate efzofitimod in patients with systemic sclerosis-related interstitial lung disease, with interim data expected in Q2 2025 [4][7] Financial Position - As of March 31, 2025, aTyr Pharma had cash and cash equivalents totaling $78.8 million, which is projected to fund operations for one year following the Phase 3 EFZO-FIT™ readout [10][15] - General and administrative expenses for Q1 2025 were reported at $4.0 million, slightly higher than the previous year's $3.5 million [10][13]
aTyr Pharma Presents Preclinical Data for NRP2-Targeting Antibody ATYR2810 at the American Association for Cancer Research (AACR) Annual Meeting 2025
GlobeNewswire News Room· 2025-04-29 12:00
Core Insights - aTyr Pharma, Inc. is presenting preclinical data for ATYR2810, a monoclonal antibody targeting neuropilin-2 (NRP2), at the AACR Annual Meeting 2025, indicating progress in its clinical development [1][2] Group 1: Company Overview - aTyr Pharma is a clinical stage biotechnology company focused on developing first-in-class medicines from its proprietary tRNA synthetase platform [1][4] - The company's lead therapeutic candidate is efzofitimod, which is in clinical development for treating interstitial lung disease [4] Group 2: Research Findings - ATYR2810 has shown potential in combating drug resistance mechanisms in aggressive cancers like glioblastoma multiforme (GBM) [2][3] - Preclinical research indicates that ATYR2810 enhances anti-tumor immunity and significantly increases overall survival when used as a single agent [3] - The combination of ATYR2810 with anti-PD-1 therapies further improves survival rates and reduces tumor size in GBM models [3]
aTyr Pharma to Participate in April Investor Conferences
Globenewswire· 2025-04-03 12:00
SAN DIEGO, April 03, 2025 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the company will participate in two upcoming investor conferences scheduled to take place in April 2025. Details of the conferences appear below: Conference: Jones Healthcare and Technology Innovation Conference Date: April 8 – 9, 2025Location: Las Vegas, ...
aTyr Pharma Announces the Appointment of Dalia R. Rayes as Head of Commercial, Global Efzofitimod Franchise
Newsfilter· 2025-03-26 12:00
Core Viewpoint - aTyr Pharma has appointed Dalia R. Rayes as Head of Commercial for the Global Efzofitimod Franchise, aiming to advance the commercialization of efzofitimod, a potential first treatment for pulmonary sarcoidosis in over 70 years [1][2]. Company Overview - aTyr Pharma is a clinical stage biotechnology company focused on developing first-in-class medicines from its proprietary tRNA synthetase platform, targeting therapies for fibrosis and inflammation [4]. - The lead therapeutic candidate, efzofitimod, is in clinical development for interstitial lung disease (ILD), which includes immune-mediated disorders causing lung inflammation and fibrosis [4]. Appointment Details - Dalia R. Rayes brings over 25 years of experience in biotechnology and pharmaceuticals, having led product launches in rare diseases [1][2]. - Ms. Rayes previously served as Senior Vice President at ChemoCentryx, where she developed the commercial strategy for TAVNEOS® prior to its acquisition by Amgen [2]. - She has also held significant roles at Actelion Pharmaceuticals, contributing to the launch of products like VALCHLOR® and OPSUMIT® [2]. Compensation Package - As part of her appointment, Ms. Rayes was granted an option to purchase 225,000 shares of aTyr's common stock at an exercise price of $3.49 per share, with a vesting schedule over four years [3].
aTyr Pharma: Good Safety Data In Pulmonary Sarcoidosis, Institutions Are Accumulating
Seeking Alpha· 2025-03-14 19:10
Group 1 - aTyr Pharma is preparing for its first pivotal event of the year, which is an interim readout, although it is considered the least interesting by some analysts [1] - The company is part of a broader focus on growth markets, particularly in the biotech sector, which is seen as having significant potential [1] - The investment strategy includes looking for undervalued stocks with strong scientific backgrounds, indicating a focus on fundamental analysis [1] Group 2 - The analyst has a beneficial long position in aTyr Pharma's shares, indicating confidence in the company's future performance [2] - The article expresses personal opinions and does not involve compensation from the company, suggesting an independent analysis [2] - There is no business relationship with aTyr Pharma, reinforcing the objectivity of the analysis [2]
aTyr Pharma, Inc.(ATYR) - 2024 Q4 - Earnings Call Transcript
2025-03-14 03:18
aTyr Pharma, Inc. (NASDAQ:ATYR) Q4 2024 Earnings Conference Call March 13, 2025 5:00 PM ET Company Participants Ashlee Dunston - Senior Director of Investor Relations and Public Affairs Sanjay Shukla - President and Chief Executive Officer Leslie Nangle - Vice President of Research Jill Broadfoot - Chief Financial Officer Conference Call Participants Derek Archila - Wells Fargo & Company Yasmeen Rahimi - Piper Sandler Companies Faisal Khurshid - Leerink Partners LLC Prakhar Agrawal - Cantor Fitzgerald, L.P. ...
aTyr Pharma, Inc.(ATYR) - 2024 Q4 - Annual Report
2025-03-13 21:19
Clinical Development - Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), with orphan drug designations granted by the FDA and European Commission for sarcoidosis and systemic sclerosis-associated ILD[21][22]. - The Phase 1b/2a clinical trial demonstrated that efzofitimod was safe and well-tolerated at all doses, with significant improvements in steroid reduction and lung function compared to placebo[22]. - The EFZO-FIT study, a pivotal Phase 3 trial for efzofitimod, has enrolled 268 patients, exceeding the target of 264, with topline data expected in Q3 2025[24][30]. - The company has initiated an Individual Patient Expanded Access Program for efzofitimod, allowing patients who completed the EFZO-FIT study to receive treatment outside of the clinical trial[25]. - The EFZO-CONNECT study is underway to evaluate efzofitimod in patients with systemic sclerosis-associated ILD, with interim data expected in Q2 2025[26][32]. - The primary endpoint of the EFZO-FIT study is steroid reduction, with secondary endpoints including lung function assessed by FVC and health-related quality of life[52]. - The study incorporates a forced steroid taper, starting from a dose of 7.5-25 mg/day of prednisone to a target dose of 0.0 mg/day[53]. - Efzofitimod demonstrated a 58% overall steroid reduction from baseline and a 22% relative reduction compared to placebo in the 5.0 mg/kg treatment group[61]. - The absolute improvement in FVC (Forced Vital Capacity) at week 24 was 3.3% in the 5.0 mg/kg treatment group compared to placebo, with an improvement of >2.5% considered clinically meaningful[61]. - The EFZO-CONNECT study, a Phase 2 trial for SSc-ILD, is set to enroll up to 25 patients and aims to report interim data in Q2 2025[63]. Financial Overview - The company anticipates continued significant losses as it progresses through clinical development and seeks additional capital or strategic partnerships[23]. - The market price of the company's common stock has historically been highly volatile, posing risks to investors[23]. - The company has approximately $75.1 million in cash, cash equivalents, restricted cash, and available-for-sale investments as of December 31, 2024, which is expected to meet material cash requirements for at least one year[205]. - The company incurred a consolidated net loss of $64.0 million for the year ended December 31, 2024, with an accumulated deficit of $532.0 million as of the same date[211]. - The company has not generated any revenue from product sales since its inception in 2005 and does not anticipate doing so in the foreseeable future[215]. - The company expects to continue incurring significant expenses and operating losses as it advances research and clinical development of its product candidates, including efzofitimod[213]. - The company has financed its operations primarily through the sale of equity securities and convertible debt, and future net losses will depend on the rate of expenditures and ability to obtain funding[212]. - The company may face challenges in raising funds due to global geopolitical and macroeconomic conditions, which could affect its ability to continue operations and capitalize on business opportunities[209]. Regulatory and Compliance - The FDA regulates the approval process for biologics, which requires substantial time and financial resources, and non-compliance could lead to significant sanctions[103]. - The company is preparing for a potential Biologics License Application (BLA) submission for efzofitimod, with ongoing work on process performance qualification batches[86]. - The FDA typically conducts a pre-approval inspection of manufacturing facilities to ensure compliance with cGMP requirements before approving a BLA[113]. - The FDA may grant Fast Track designation for drugs addressing serious conditions, allowing for more frequent interactions and priority review[117]. - Orphan drug designation can provide financial incentives and exclusivity for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[125]. - The company must submit an IND to the FDA, which becomes effective 30 days after receipt unless concerns are raised[105]. - The FDA may approve a BLA based on surrogate endpoints under the accelerated approval program, requiring post-marketing trials to verify clinical benefit[120]. - The company must conduct expensive pharmacoeconomic studies to demonstrate the medical necessity and cost-effectiveness of its products for third-party payors[135]. - The company is subject to various federal and state laws targeting fraud and abuse in the healthcare industry, which may impact sales and marketing programs[140]. - The company must obtain requisite approvals from regulatory authorities in foreign countries prior to commencing clinical trials or marketing products[132]. Intellectual Property - The company has over 300 issued patents or allowed patent applications, with expiration dates ranging from 2026 to 2034, to protect its proprietary technologies[87]. - The efzofitimod patent portfolio includes issued patents in multiple countries, with U.S. patents expected to expire between 2030 and 2031[93]. - The company plans to continue expanding its intellectual property estate by filing new patent applications for novel therapeutic methods and product forms[90]. Product Development and Market Potential - The company believes there is a substantial unmet need for safer, more effective therapies for pulmonary sarcoidosis, positioning efzofitimod as the most advanced candidate in development for this condition[76]. - The global market opportunity for efzofitimod in pulmonary sarcoidosis and SSc-ILD is estimated to be between $2 billion and $5 billion[78]. - Efzofitimod is currently in development for SSc-ILD, a condition with limited treatment options and significant side effects associated with existing therapies[77]. - The company has licensed rights to Kyorin for the development and commercialization of efzofitimod in Japan[80]. - The company relies on contract development and manufacturing organizations (CDMOs) for the production of efzofitimod, which has proven to be cost-efficient[82]. - The first and second full commercial-scale bulk drug substance GMP runs for efzofitimod were completed successfully in 2023, meeting all release specifications[86]. - The company has engaged an additional CDMO to manufacture efzofitimod, completing technology transfer and validation processes[178]. Challenges and Risks - The company has faced delays in clinical trials due to challenges in patient enrollment and compliance with study protocols[154]. - The ongoing clinical trials, including the EFZO-CONNECT study, may encounter significant delays or require additional studies if initial results are perceived as negative[156]. - The company may face challenges in identifying and enrolling a sufficient number of patients for clinical trials due to the rarity of certain diseases[166]. - The company has not yet completed any human clinical trials that demonstrate efficacy to the satisfaction of the FDA[160]. - The FDA has substantial discretion in the approval process, which may lead to additional trials being required, delaying potential approvals[162]. - The company may not receive orphan drug designation for efzofitimod in other jurisdictions or for other indications[181]. - Any regulatory sanctions or withdrawal of approvals could significantly harm the company's market value and operating results[194]. - The company’s product candidates may cause undesirable side effects that could delay or prevent regulatory approval[202]. - The company’s ability to commercialize products may be adversely affected by public perception of safety issues and slow adoption by healthcare providers[199]. - The company’s discovery platform may not yield commercially viable drugs, impacting its business and financial condition[204].
aTyr Pharma, Inc.(ATYR) - 2024 Q4 - Earnings Call Transcript
2025-03-13 21:00
Financial Data and Key Metrics Changes - The company ended 2024 with $75.1 million in cash, restricted cash, cash equivalents, and investments [31] - Research and development expenses were $54.4 million for the year, primarily for clinical trial costs and manufacturing [32] - General and administrative expenses totaled $13.8 million for the year [32] Business Line Data and Key Metrics Changes - Collaboration and license revenue related to the Kirin agreement was $200,000 for the year, with over $20 million received to date [31] - The company is eligible for up to $155 million in additional milestone payments from Kirin, primarily for regulatory and commercial milestones for sarcoidosis [31] Market Data and Key Metrics Changes - The company estimates a total global market opportunity for esofitimod in interstitial lung disease (ILD) at $2 billion to $5 billion, with sarcoidosis representing a significant portion of that range [20] - Recent claims analysis indicates that the number of patients diagnosed with lung involvement is 30% higher than previously estimated, with around 200,000 people affected in the U.S. [16][17] Company Strategy and Development Direction - The company aims to position esofitimod as a potential frontline steroid-reducing agent for patients with moderate to severe sarcoidosis, addressing 50% to 75% of all sarcoidosis patients [20] - The company is also exploring esofitimod for ILD related systemic sclerosis (scleroderma), with a Phase II study currently enrolling patients [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the favorable safety profile of esofitimod, bolstered by four positive Data and Safety Monitoring Board reviews [11] - The company anticipates significant market opportunities with little competition in the sarcoidosis space, supported by new claims data [34] Other Important Information - The company recently appointed Eric Benovich, a seasoned executive in launching high-value pharmaceuticals, to its Board of Directors [21] - A publication in the journal Science Translational Medicine validates the immune regulatory properties of esofitimod, enhancing its scientific rationale [28] Q&A Session Summary Question: Can you shed some light on how measuring the absolute change in steroid reduction impacts the trial? - Management explained that the new method simplifies data analysis and maintains over 90% powering for the trial [39][40] Question: What is the percent of patients in the trial rolling over into the expanded access program? - Management noted that interest in the expanded access program is robust, but specific numbers are difficult to provide due to varying regulatory requirements across countries [42][44] Question: What should investors look for in the baseline demographics from the study? - Management highlighted the importance of average prednisone dose and background immunomodulator use as key metrics to monitor [55] Question: How should we think about the durability of the drug impact? - Management indicated that durability is crucial and will be assessed through time to relapse and clinical worsening as tertiary endpoints [62] Question: What is the current manufacturing readiness for potential commercialization? - Management confirmed that significant investments have been made to ensure commercial readiness and drug supply for patients [86][88]
aTyr Pharma, Inc.(ATYR) - 2024 Q4 - Annual Results
2025-03-13 20:03
Financial Performance - Total revenues for the year ended 2024 were $0.235 million, a decrease from $0.353 million in 2023[15] - The consolidated net loss for the year ended 2024 was $64.0 million, compared to a net loss of $50.4 million in 2023[15] - Research and development expenses for the year ended 2024 were $54.4 million, primarily for clinical trial costs[8] - General and administrative expenses for the year ended 2024 were $13.8 million[8] Cash and Assets - Cash and cash equivalents as of December 31, 2024, were $75.1 million, with an additional $18.8 million raised post-Q4 2024[8] - Total assets decreased from $120,653 million in 2023 to $96,830 million in 2024, representing a decline of approximately 19.7%[17] - Cash and cash equivalents dropped from $101,650 million in 2023 to $75,076 million in 2024, a decrease of about 26.1%[17] - Total stockholders' equity fell from $90,470 million in 2023 to $69,832 million in 2024, reflecting a reduction of approximately 22.8%[17] Liabilities and Expenses - Accounts payable and accrued expenses decreased from $15,088 million in 2023 to $13,715 million in 2024, a decline of about 9.1%[17] - Long-term operating lease liability, net of current portion, decreased from $12,339 million in 2023 to $11,144 million in 2024, a reduction of approximately 9.7%[17] - Current portion of operating lease liability decreased from $831 million in 2023 to $711 million in 2024, a decline of approximately 14.4%[17] - Current portion of financing lease liability increased from $497 million in 2023 to $541 million in 2024, an increase of about 8.8%[17] - Financing lease right-of-use assets decreased from $1,788 million in 2023 to $1,192 million in 2024, a decline of approximately 33.4%[17] - Other receivables decreased from $2,436 million in 2023 to $1,736 million in 2024, a decline of about 28.7%[17] Clinical Trials and Studies - Topline data from the Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis is expected in Q3 2025[1] - The Phase 3 EFZO-FIT™ study enrolled 268 patients across 85 centers in nine countries, with a total of 12 doses administered[5] - The fourth positive DSMB review for the Phase 3 EFZO-FIT™ study confirmed the favorable safety profile of efzofitimod[4] - Interim data from the Phase 2 EFZO-CONNECT™ study is expected in Q2 2025, focusing on skin assessments in approximately 8 patients[6] Financial Guidance - The company updated its financial guidance, indicating sufficient cash runway for one year following the Phase 3 EFZO-FIT™ readout[8]