SAN DIEGO, June 03, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-inclass medicines from its proprietary tRNA synthetase platform, today announced that the Company will be changing its ticker symbol from "LIFE" to "ATYR." Effective at the market open on June 5, 2024, the Company's common stock will trade on the Nasdaq Capital Market under the new symbol "ATYR." "As we advance our le ...

Vancouver, British Columbia--(Newsfile Corp. - May 30, 2024) - Cruz Battery Metals Corp. (CSE: CRUZ) (OTC Pink: BKTPF) (FSE: A3CWU7) ("Cruz" or the "Company") has arranged a non-brokered listed issuer financing exemption (LIFE) private placement of up to 6,250,000 units at a price of $0.036 per unit. Each unit will comprise of one common share of the Company and one share purchase warrant to purchase one common share of the Company at a price of $0.05 for a period of 60 months from the Closing Date. The Off ...

aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr's discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetase ...

On this news, the price of Globe Life's shares fell by $55.76 per share, or 53%, from a closing price of $104.93 per share on April 10, 2024, to a closing price of $49.17 per share on April 11, 2024. NEW ORLEANS, May 17, 2024 /PRNewswire/ -- ClaimsFiler, a FREE shareholder information service, reminds investors that they have until July 1, 2024 to file lead plaintiff applications in a securities class action lawsuit against Globe Life Inc. f/k/a Torchmark Corporation (NYSE: GL), if they purchased or otherwi ...

TORONTO, May 15, 2024 (GLOBE NEWSWIRE) -- DiagnaMed Holdings Corp. ("DiagnaMed" or the "Company") (CSE: DMED) (OTCQB: DGNMF), a healthcare technology company focused on brain health using AI, is pleased to announce that it is arranging a private placement of a minimum of $400,000 and a maximum of $650,000 of units (each, a "Unit"), at a price of $0.04 per Unit; (the "Offering"). The Offering is being led by EMD Financial Inc. Each Unit will be comprised of one common share ("Common Share") in the capital of ...

Independent data and safety monitoring board (DSMB) recommends continuation of study without any modifications. Findings further support favorable safety profile of efzofitimod. SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE) (aTyr or the "Company"), 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 an independent data and safety monitoring board (DSMB) r ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37378 ATYR PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 20-3435077 (State or other jurisdiction ...

Exhibit 99.1 IMMEDIATE RELEASE Contact: Ashlee Dunston Director, Investor Relations and Public Affairs adunston@atyrpharma.com aTyr Pharma Announces First Quarter 2024 Results and Provides Corporate Update Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis expected to complete enrollment in the second quarter of 2024. Ended the first quarter 2024 with $87.7 million in cash, cash equivalents, restricted cash and investments. SAN DIEGO – May 2, 2024 – aTyr Pharma, Inc. (Nasdaq: LIFE) ("aTyr" or t ...

Call Start: 17:00 January 1, 0000 5:43 PM ET aTyr Pharma, Inc. (NASDAQ:LIFE) Q4 2023 Earnings Conference Call March 14, 2024, 17:00 ET Company Participants Ashlee Dunston - Director, IR & Corporate Communications Sanjay Shukla - President, CEO & Director Jill Broadfoot - CFO Conference Call Participants Gregory Renza - RBC Capital Markets Joe Pantginis - H.C. Wainwright & Co. Yale Jen - Laidlaw & Company Robert LeBoyer - Noble Capital Markets Operator Good afternoon, ladies and gentlemen, and welcome to the ...

Clinical Development - Efzofitimod is a first-in-class biologic immunomodulator in clinical development for interstitial lung disease (ILD), with orphan drug designations from the FDA for sarcoidosis and systemic sclerosis (SSc) [21] - The Phase 1b/2a clinical trial for efzofitimod demonstrated safety and tolerability across all doses (1.0, 3.0, and 5.0 mg/kg) in 37 patients, with no serious drug-related adverse events [22] - The ongoing EFZO-FIT Phase 3 study aims to enroll up to 264 subjects with pulmonary sarcoidosis, evaluating the efficacy and safety of efzofitimod over 52 weeks [23] - The EFZO-CONNECT study, initiated in Q3 2023, targets SSc-ILD with a planned enrollment of 25 patients, assessing the efficacy of efzofitimod at doses of 270 mg and 450 mg [26] - The DSMB has approved the continuation of the EFZO-FIT study without modifications, with expected enrollment completion in Q2 2024 [24] - The ongoing Phase 3 EFZO-FIT study aims to enroll up to 264 patients with symptomatic pulmonary sarcoidosis, evaluating the efficacy and safety of efzofitimod at doses of 3.0 mg/kg and 5.0 mg/kg [54] - The Phase 1b/2a clinical trial demonstrated that efzofitimod was safe and well-tolerated across all doses, with no serious adverse events reported [62] - In the Phase 1b/2a trial, efzofitimod showed consistent dose response on key efficacy endpoints, including steroid reduction and improvements in lung function [62] - The EFZO-FIT study incorporates a forced steroid taper, aiming to reduce the need for oral corticosteroids in patients [54] - The first patient in the EFZO-FIT study was dosed in September 2022, with enrollment expected to complete by the second quarter of 2024 [56] - The Individual Patient EAP has been initiated to provide access to efzofitimod for patients completing the Phase 3 study [57] - Efzofitimod demonstrated a 58% overall reduction in steroid usage from baseline and a 22% relative reduction compared to placebo in the 5.0 mg/kg treatment group [64] - 33% of patients in the 5.0 mg/kg treatment group achieved and maintained complete steroid taper to 0 mg, while no patients in other groups achieved this [64] - The absolute improvement in FVC 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 [64] - The Phase 2 clinical trial for efzofitimod in COVID-19 patients showed that a single IV dose was generally safe and well-tolerated [66] - The company is currently enrolling subjects in the EZFO-FIT study across the United States, Europe, Brazil, and Japan [184] - The company has established clinical proof-of-concept for efzofitimod in a Phase 1b/2a trial for pulmonary sarcoidosis, but further validation is needed [182] Financial Aspects - The Kyorin Agreement has generated $20 million in upfront and milestone payments, with potential for an additional $155 million upon achieving certain milestones in Japan [27] - The company anticipates continued significant losses as a pre-commercial biotherapeutics entity, relying on collaborations for product development [24] - The global market opportunity for pulmonary sarcoidosis and SSc-ILD is estimated to be between $2 billion and $3 billion [82] - As of December 31, 2023, the company's cash, cash equivalents, restricted cash, and available-for-sale investments totaled approximately $101.7 million, expected to meet material cash requirements for at least one year [213] - The company may need to raise additional capital or enter strategic partnerships to fund operations, with future funding requirements being difficult to forecast [213] - The company anticipates fluctuations in research and development expenses due to the high costs associated with developing therapeutic product candidates [213] Regulatory Considerations - The strategy includes expediting efzofitimod's regulatory approval for pulmonary sarcoidosis based on positive Phase 1b/2a results [31] - The FDA requires a Biologics License Application (BLA) submission that includes comprehensive data from preclinical and clinical studies, including both positive and negative results [115] - The FDA may issue an approval letter or a Complete Response Letter (CRL) after evaluating a BLA, with a CRL indicating that the application is not ready for approval [118] - The company may seek expedited review and accelerated approval programs, such as Fast Track designation, which allows for more frequent interactions with the FDA [120] - Orphan drug designation can be granted for drugs treating rare diseases, providing financial incentives and potential exclusivity for seven years if the product is the first approved for that indication [129] - The company has received orphan drug designation for efzofitimod for the treatment of sarcoidosis and systemic sclerosis in the US and EU, but this may not confer marketing exclusivity in other jurisdictions [201] - Regulatory approvals may be subject to limitations on approved uses and conditions, potentially requiring costly post-marketing studies [208] - The approval process in other jurisdictions may differ significantly from the FDA process, potentially leading to longer timelines for regulatory approval [134] - The company must obtain necessary approvals from foreign regulatory authorities before commencing clinical trials or marketing products in those countries [135] - The FDA may not accept data from clinical trials conducted outside the U.S., which could delay development plans [185] Manufacturing and Supply Chain - The company currently relies on contract development and manufacturing organizations (CDMOs) for the manufacturing and testing of product candidates, including efzofitimod [86] - The CDMO engaged in late 2021 completed its first and second full commercial-scale bulk drug substance GMP runs in 2023, meeting all release specifications [89] - Manufacturing of product candidates must comply with cGMP regulations, and any failure could impact clinical trial supplies [192] - The company is producing efzofitimod in E. coli, which may require complex manufacturing processes not easily adaptable to other candidates [195] - The company relies on third parties for the production of clinical and commercial quantities, which may face compliance issues during FDA inspections [126] Competitive Landscape - The biotechnology and pharmaceutical industries face intense competition, with potential challenges from companies with greater resources [77] - Clinical trial delays could shorten exclusive commercialization rights and allow competitors to bring products to market sooner, adversely affecting the company's business prospects [177] - The company is focusing its R&D efforts on extracellular functions of tRNA synthetase biology, with product candidates like efzofitimod and others derived from DARS and AARS proteins [178] Employee and Operational Considerations - As of December 31, 2023, the company had 59 employees, with 56 being full-time, including 36 in research and development roles [150] - The company operates in a highly competitive biotechnology industry, emphasizing the importance of attracting and retaining talented employees [151] - The company has a Code of Business Conduct and Ethics to ensure core values are upheld throughout its operations [152] - The company emphasizes the importance of employee health and safety, maintaining low occupational injury rates [153] Market and Economic Factors - The company may face significant uncertainty regarding coverage and reimbursement for its products from third-party payors, affecting sales potential [137] - The U.S. government has shown interest in implementing cost containment programs that could reduce the profitability of drug products [139] - The Inflation Reduction Act of 2022 includes provisions that may impact drug pricing and reimbursement, with negotiations for certain high-expenditure drugs starting in fiscal year 2023 [141] - Financial markets experienced volatility due to the Ukraine-Russia conflict, impacting trade and pricing stability globally [219] - The conflict has led to rapidly rising costs of living in Europe, primarily driven by higher energy prices [219] - Ongoing sanctions against Russia may disrupt supply chain continuity and credit availability in Europe and globally [219] - The situation has introduced significant uncertainty into global markets, affecting business operations [219] - The conflict in the Middle East has also resulted in trade disruptions and increased supply chain costs [219] - A weak or declining economy could strain suppliers and manufacturers, potentially disrupting production [219] - The company’s operations may be adversely affected if the Ukraine-Russia conflict escalates further [219] Challenges and Risks - The company faces challenges in patient enrollment due to the limited number of patients with the diseases being studied, which could delay clinical development [172] - The EFZO-FIT study lacks an established FDA regulatory pathway for approval, which may hinder the ability to support FDA approval even if the study is successful [165] - The company has expended significant resources on the discovery and development of product candidates but has not yet completed any human clinical trials demonstrating efficacy to the FDA's satisfaction [164] - Delays in clinical trials could result from various factors, including patient dropout, adverse events, and geopolitical tensions, which may compromise data integrity [163] - The company may need to conduct additional clinical trials if initial results are perceived as negative or inconclusive, delaying marketing approval [161] - The FDA has substantial discretion in the approval process and may require additional trials, which could significantly delay potential regulatory approval [166] - The company may face increased costs and delays in product development if it cannot enroll a sufficient number of eligible patients for clinical trials [176] - Undesirable side effects from product candidates could delay or prevent regulatory approval, impacting market acceptance [187] - The company is subject to ongoing regulatory scrutiny even after obtaining product approvals, which includes compliance with manufacturing and labeling requirements [206] - Any government investigation of alleged violations could require significant resources and negatively impact the company's ability to commercialize products [212]