Workflow
Athira Pharma(ATHA)
icon
Search documents
Athira Pharma (NasdaqGS:ATHA) Update / Briefing Transcript
2025-12-18 14:32
Summary of Athira Pharma Conference Call - December 18, 2025 Company Overview - **Company**: Athira Pharma (NasdaqGS:ATHA) - **Focus**: Development of innovative therapies for diseases with unmet medical needs, specifically in oncology and neurology Key Points Discussed Transformative Acquisition - Athira announced the acquisition of rights to develop and commercialize **lasofoxifene**, a potential treatment for metastatic breast cancer, which diversifies its pipeline with a late-stage program [5][15][16] - The acquisition is expected to enhance Athira's mission to deliver transformative therapies for patients [5][14] Lasofoxifene Overview - Lasofoxifene is currently in a pivotal phase III clinical trial targeting **ER-positive HER2-negative metastatic breast cancer**, which represents about 70% of all breast cancer cases [15][16] - The global market for metastatic ER-positive HER2-negative breast cancer is projected to grow from **$10.9 billion in 2025 to over $15.9 billion by 2029** [15] - Lasofoxifene has shown promising clinical activity, achieving **13 months of progression-free survival (PFS)** in combination therapy during phase II trials [20][26] Clinical Data and Mechanism - Lasofoxifene demonstrated an **83% reduction in new-onset primary wild-type estrogen receptor-positive breast cancer** in previous studies [19] - It modulates the estrogen receptor rather than degrading it, providing tissue selectivity and sparing healthy estrogen receptors in critical tissues [19][21] - The drug has shown **significant efficacy against ESR1 mutations**, which occur in over 40% of patients and are a major mechanism of resistance in breast cancer treatments [20][21] ATH-1105 for ALS - Athira is also advancing **ATH-1105**, a potential treatment for **Amyotrophic Lateral Sclerosis (ALS)**, which affects approximately **33,000 patients in the U.S.** [37] - ATH-1105 modulates the hepatocyte growth factor (HGF) system, which is critical for neuronal health [38] - Preclinical studies have shown that ATH-1105 preserves motor function and reduces neurodegeneration in ALS models [39][40] Financial and Strategic Positioning - Athira raised **$90 million** to support its development programs, with the potential for an additional **$146 million** through warrants [46] - The financing positions the company to reach critical data readouts across both programs by the end of **2027** [46] - Athira aims to achieve peak annual U.S. sales for lasofoxifene approaching **$1 billion** if approved [35] Market Opportunity - The global breast cancer market is approximately **$55 billion**, with the second-line breast cancer segment in the U.S. exceeding **$5-$6 billion annually** [34] - Lasofoxifene's favorable tolerability profile and unique attributes position it as a potential leading therapy in this market [35][36] Conclusion - Athira is committed to advancing its promising development programs for lasofoxifene and ATH-1105, addressing significant unmet needs in metastatic breast cancer and ALS [45] - The company is optimistic about its future and the potential impact of its therapies on patient outcomes [47]
Athira Pharma (NasdaqGS:ATHA) Earnings Call Presentation
2025-12-18 13:30
Lasofoxifene (Metastatic Breast Cancer) - The global metastatic ER+/HER2- breast cancer market is expected to grow from approximately $10.9 billion in 2025 to roughly $15.9 billion by 2029[23] - Lasofoxifene, combined with abemaciclib, demonstrated a potential best-in-class median Progression-Free Survival (PFS) of 13 months in a heavily pre-treated mESR1 population in the Phase 2 ELAINE-2 trial[26, 27, 50] - In the ELAINE-1 Phase 2 study, lasofoxifene delivered a median PFS of 24.2 weeks compared to 16.2 weeks with fulvestrant in ESR1-mutant breast cancer[48] - Approximately 70% of all breast cancers are ER+/HER2- subtype[23, 32] - Lasofoxifene reduced new onset breast cancer by 83% in a large prevention trial[30] - The ELAINE-3 registrational Phase 3 trial is ongoing, with topline results expected in mid-2027 and over 50% enrollment[16, 17, 57, 138, 139] - Assuming approximately 10% market penetration, lasofoxifene has a peak market sale potential of over $1 billion in the US market[81] ATH-1105 (ALS) - Approximately 225,000 people globally are affected by ALS, with roughly 33,000 cases in the US[98] - ATH-1105 is a CNS-penetrant positive modulator of HGF as a potential treatment for ALS[103] - A Phase 2 POC study in ALS is planned to start in the first half of 2026, with topline results expected in 2027[18, 19, 140, 141] Financial - A PIPE financing of up to $236 million, including $90 million upfront, provides cash runway through data readout and into 2028[137]
Athira Pharma Announces Exclusive License to Lasofoxifene Phase 3 Development Program for Metastatic Breast Cancer Candidate and a Financing for up to $236 Million
Globenewswire· 2025-12-18 12:02
Phase 3 Development Program of Novel Selective Estrogen Receptor Modulator (SERM) Represents Potential Multi-Billion Dollar Opportunity as Treatment Option for Patients with ESR1-Mutations Financing Co-Led by Commodore Capital, Perceptive Advisors and TCGX Supports Development of Lasofoxifene through Phase 3 Clinical Topline Data Readout and Regulatory Milestones Conference Call Today at 8:30 am Eastern Time BOTHELL, Wash., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a clinical-sta ...
Athena Gold Closes Second Tranche of Non-brokered Private Placement and Increases Offering Due to Strong Demand
Accessnewswire· 2025-12-15 17:15
THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT AUTHORIZED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES WHITE ROCK, BRITISH COLUMBIA / ACCESS Newswire / December 15, 2025 / Athena Gold Corporation (CSE:ATHA)(OTCQB:AHNRF) ("Athena Gold" or the "Company") is pleased to announce that, further to its news releases of November 17, November 24 and December 9, 2025, the Company has closed the second tranche of its private placement financing ...
Athena Gold Closes First Tranche of Non-Brokered Private Placement and Announces Further Upsize
Accessnewswire· 2025-12-09 12:00
Core Viewpoint - Athena Gold Corporation has successfully closed the first tranche of a non-brokered private placement, raising a total of CDN $2,727,526.03 out of a targeted CDN $3,100,000 [1] Fundraising Details - The first tranche includes CDN $1,331,801.03 raised through the issuance of 19,025,729 flow-through units at a price of CDN $0.07 per unit [1] - An additional CDN $1,015,500.08 was raised through the issuance of 14,507,144 flow-through common shares at the same price of CDN $0.07 per share [1] - Lastly, CDN $380,224.92 was raised through the issuance of 6,337,082 non-flow-through units at a price of CDN $0.06 per unit [1]
Athena Gold Provides Exploration Update From Excelsior Gold-Silver Project, Nevada
Accessnewswire· 2025-11-26 12:00
Core Insights - Athena Gold Corporation has reported positive results from diamond drilling at its Excelsior Springs Project, with a notable return of 4.33 g/t Au over 14.4 meters [1] - Mammoth Minerals Limited is actively exploring the Excelsior Springs Project under an option agreement to earn an 80% interest over five years, which allows Athena to benefit from a free-carry to a Definitive Feasibility Study thereafter [1] Company Developments - The exploration update highlights the ongoing efforts and progress made at the Excelsior Springs Project in Nevada [1] - The partnership with Mammoth Minerals Limited is significant as it indicates a strategic collaboration that could enhance the project's value and development potential [1]
ATHA Energy Confirms New High-Grade Discovery at Angilak Project - Rib North, Maiden Hole Returns Assays with 34.7 m of Total Composite Uranium Mineralization, Including 13.6 m Grading 0.53% U3O8, 1.1 m Grading 4.81% U3O8, and Grades Up to 8.16% U3O8
Accessnewswire· 2025-11-20 12:00
Core Insights - The assays from the Company's maiden drillhole, RIBN-DD-001, at the RIB North Discovery have confirmed it as the best exploration hole drilled to date at the Angilak Uranium Project [1] - RIBN-DD-001 assays returned a total composite uranium mineralization of 34.7 meters, encompassing seven zones from 287.0 meters to 439.9 meters, surpassing preliminary results reported on September 23rd, 2025 [1] - The widest continuous intersection in the hole, from 426.3 to 439.9 meters, returned 13.6 meters of composite uranium mineralization grading 0.53% U3O8, including a notable 1.1 meters grading 4.81% U3O8, with the highest-grade sample returning 8.16% U3O8 over 0.5 meters [1] - Mineralization was first intersected in sandstone over three intervals between 287.0 meters and 351.1 meters, with the fourth zone intersected directly above the unconformity at 356.7 meters, extending into graphitic basement rock below [1]
Athira Pharma(ATHA) - 2025 Q3 - Quarterly Report
2025-11-06 21:13
Financial Performance - The company reported net losses of $22.7 million and $81.9 million for the nine months ended September 30, 2025, and 2024, respectively, with an accumulated deficit of $428.9 million as of September 30, 2025[107]. - Net loss for the three months ended September 30, 2025, was $28.7 million, compared to a net loss of $6.6 million in Q3 2024, representing a 77% increase in loss[123]. - Total operating expenses for the three months ended September 30, 2025, were $6.9 million, down 77% from $29.6 million in the same period of 2024[123]. - Total operating expenses for the nine months ended September 30, 2025, were $23.7 million, a decrease of 72% from $85.3 million in the same period of 2024[129]. - Net cash used in operating activities was $26.3 million for the nine months ended September 30, 2025, compared to $71.2 million in 2024[142][143]. Cash and Investments - Cash, cash equivalents, and investments totaled $25.2 million as of September 30, 2025[107]. - The company anticipates that existing cash, cash equivalents, and investments will be sufficient to fund operations for at least the next 12 months[110]. - As of September 30, 2025, the company had $25.2 million in cash, cash equivalents, and investments, sufficient to fund operations for at least the next 12 months[134][136]. - The company has raised approximately $407.4 million in net cash proceeds since inception, primarily from equity securities[107]. - The company raised aggregate net cash proceeds of $407.4 million since inception, primarily from the issuance of common stock[133]. Research and Development - ATH-1105, the lead drug candidate, is currently in Phase 1 clinical trials for the treatment of amyotrophic lateral sclerosis (ALS) and has shown a favorable safety profile[99][102]. - The LIFT-AD trial for the previous lead drug candidate, fosgonimeton, did not reach statistical significance, leading to a pause in its development[100]. - The company has paused further development of fosgonimeton and shifted focus to the clinical development of ATH-1105[117]. - Research and development expenses decreased by $50.5 million, from $61.3 million in 2024 to $10.8 million in 2025, a reduction of 82%[130]. - Research and development expenses for the nine months ended September 30, 2025, were $10.8 million, down 82% from $61.3 million in the same period of 2024[129]. - The company expects to continue incurring research and development expenses as drug candidates advance into later stages of development[117]. - The current focus is on enhancing the neurotrophic HGF system to treat neurodegenerative diseases[98]. Operating Expenses - Research and development expenses decreased by $15.1 million, from $17.9 million in Q3 2024 to $2.8 million in Q3 2025, a reduction of 84%[123]. - General and administrative expenses decreased by approximately $3.6 million, from $7.6 million in Q3 2024 to $4.0 million in Q3 2025, a decrease of 47%[126]. - General and administrative expenses decreased by approximately $7.0 million, from $19.9 million in 2024 to $12.9 million in 2025[131]. - The company anticipates lower research and development and general administrative expenses in the near term due to a pause in the fosgonimeton program and a focus on ATH-1105[135]. - Total operating expenses for the nine months ended September 30, 2025, were $23.7 million, a decrease of 72% from $85.3 million in the same period of 2024[129]. Strategic Direction - The company is exploring strategic alternatives to maximize stockholder value, including potential acquisitions or partnerships[105]. - The company plans to build a commercial infrastructure to support future sales if drug candidates are successfully developed[106]. - The company is classified as a smaller reporting company and is not required to provide the information requested by Item 305 of Regulation S-K[154]. Other Income - Other income, net, decreased by $0.6 million, from $0.9 million in Q3 2024 to $0.3 million in Q3 2025, a decrease of 70%[127]. - Other income, net, decreased by $2.4 million, from $3.4 million in 2024 to $1.0 million in 2025[132]. Lease Obligations - The company has lease payment obligations of $1.0 million as of September 30, 2025, with $0.5 million due within 12 months[135].
Athira Pharma(ATHA) - 2025 Q3 - Quarterly Results
2025-11-06 21:09
Financial Performance - Athira Pharma reported a net loss of $6.6 million, or $1.68 per share, for the quarter ended September 30, 2025, compared to a net loss of $28.7 million, or $7.46 per share, for the same period in 2024[9][17]. - Cash, cash equivalents, and investments totaled $25.2 million as of September 30, 2025, down from $51.3 million as of December 31, 2024[8]. - Total operating expenses for the quarter were $6.9 million, down from $29.6 million in the same quarter of 2024[8][17]. Research and Development - Research and Development (R&D) expenses were $2.8 million for the quarter ended September 30, 2025, significantly lower than $17.9 million for the same quarter in 2024[8][17]. - Athira conducted a Phase 1 clinical trial of ATH-1105, enrolling 80 healthy volunteers, which demonstrated a favorable safety profile and dose proportional pharmacokinetics[4][8]. - The company aims to advance ATH-1105 into clinical trials for ALS patients following promising Phase 1 results[2][4]. - Athira's drug development pipeline includes candidates targeting neurodegenerative diseases such as ALS, Alzheimer's, and Parkinson's[3][4]. Strategic Initiatives - The company is exploring strategic alternatives to maximize stockholder value and has engaged Cantor Fitzgerald & Co. as an advisor[8][9]. - A 10-for-1 reverse stock split was implemented on September 17, 2025, to enhance the stock's marketability[8]. General and Administrative Expenses - General and Administrative (G&A) expenses decreased to $4.1 million for the quarter ended September 30, 2025, compared to $7.6 million for the same quarter in 2024[8][17].
Athira Pharma Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-06 21:05
Core Viewpoint - Athira Pharma is focused on maximizing stockholder value while advancing the clinical development of ATH-1105, a potential therapy for ALS, which has shown promising safety and pharmacokinetic profiles in Phase 1 trials [2][4]. Clinical Development & Pipeline Programs - Athira's pipeline includes small molecule drug candidates that target the neurotrophic hepatocyte growth factor (HGF) system, which is involved in neuroprotection and anti-inflammatory pathways in the central nervous system [3]. - ATH-1105 is designed to modulate the HGF system and is currently in clinical development for ALS, Alzheimer's disease, and Parkinson's disease [4]. Clinical Trial Results - The Phase 1 clinical trial of ATH-1105 enrolled 80 healthy volunteers and demonstrated a favorable safety profile, tolerability, dose proportional pharmacokinetics, and CNS penetration [7]. - Preclinical models of ALS have shown consistent beneficial effects from ATH-1105, including improvements in nerve and motor function, inflammation biomarkers, and survival rates [7]. Financial Results - As of September 30, 2025, Athira reported cash, cash equivalents, and investments of $25.2 million, down from $51.3 million at the end of 2024 [10]. - Research and Development (R&D) expenses for the quarter were $2.8 million, significantly lower than $17.9 million for the same period in 2024 [10]. - The net loss for the quarter was $6.6 million, or $1.68 per share, compared to a net loss of $28.7 million, or $7.46 per share, in the previous year [10][14]. Corporate Updates - Athira is exploring strategic alternatives to enhance stockholder value and has engaged Cantor Fitzgerald & Co. as an advisor in this process [7]. - A 10-for-1 reverse stock split was implemented on September 17, 2025, to potentially improve the stock's marketability [7].