Athira Pharma Inc 2024年度报告

Restoring Neuronal Health 9KVJVJGƂTUVKPJWOCP2JCUGENKPKECNUVWF[QH#6*KPJGCNVJ[XQNWPVGGTUEQORNGVGYGTGOCKPQPVTCEMVQFQUG#.5RCVKGPVUKP To Our Shareholders, enrolled 80 healthy volunteers to evaluate singleand multiple oral ascending doses of ATH-1105.The results of the Phase 1 study showed thatATH-1105 demonstrated a favorable safety profileand was well-tolerated in healthy volunteers,supporting continued clinical development. At Athira, we remain steadfast in our missionto develop novel innovative therapies for neuro-degenerative disease patients in need of newtreatment options. We enter 2025 with renewed energy and determi-nation. Despite the challenges we encounteredin 2024 and the ongoing uncertainties in theglobal economy and biotechnology sector, ouroptimism for the future is unwavering. Our experi-ence with cyclical downturns has taught us thatinnovative science and positive clinical outcomesare not only celebrated by patient communitiesbut are also ultimately recognized and rewardedby the markets. Accordingly, we have sharp-ened our focus on the clinical development ofATH-1105, our next-generation, orally adminis-tered small molecule drug candidate designed topositively modulate the neurotrophic HGF systemfor the potential treatment of neurodegenerativediseases such as ALS, as we seek to maximizeshareholder value. Based on these positive outcomes, we are excitedto move into ALS patients with a planned clinicaltrial of ATH-1105 later this year and expect tohave initial proof-of-concept data in 2026. We thank you for your continued support aswe advance our business and clinical develop-ment strategies, which we believe will bring uscloser to delivering transformative medicinesand new standards of care to millions of patientswho suffer from debilitating neurodegenerativediseases. As ever, we are grateful for the clinical collabo-rators and their patients who participate in ourclinical trials. Without their support, none of thisimportant work would be made possible. We have made meaningful progress advancingATH-1105 for the potential treatment of ALS,and remain highly encouraged by the neuropro-tective effects demonstrated to date. Sincerely, In various preclinical models of ALS, ATH-1105has demonstrated an ability to improve motor andnerve function, enhance neuronal survival, andimprove biomarkers of inflammation and neuro-degeneration, including neurofilament light chain(NfL), a key marker of ALS disease progression. Mark J. Litton, Ph.D.President and ChiefExecutive Officer,Athira Pharma, Inc. In November 2024, we completed the first-in-human Phase 1 clinical trial of ATH-1105 that UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549FORM 10-K(Mark One)☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2024OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FORTHE TRANSITION PERIOD FROMTOCommission File Number 001-39503Athira Pharma, Inc.(Exact name of registrant as specified in its charter)Delaware45-3368487(State or other jurisdiction ofincorporation or organization)(I.R.S. EmployerIdentification No.)18706 North Creek Parkway, Suite 104Bothell, Washington 98011(Address of principal executive officer)(425) 620-8501(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Title of each classTradingSymbol(s)Name of each exchange on which registeredCommon Stock, $0.0001 par value per shareATHAThe Nasdaq Stock Market LLC(The Nasdaq Global Select Market)Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES☐NO☒ Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES☐NO☒ Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filingrequirements for the past 90 days. YES☒NO☐ Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 ofRegulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit suchfiles). YES☒NO☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or anemerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company”in Rule 12b-2 of the Exchange Act. Large accelerated fil