UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act).
Item 2.02 Results of Operations and Financial Condition.
On May 12, 2022, Athira Pharma, Inc. (the “Company”) issued a press release reporting its financial results for the quarter ended March 31, 2022. A copy of the press release is furnished herewith as Exhibit 99.1.
Item 7.01 Regulation FD Disclosure.
The Company announces material information to the public through a variety of means, including filings with the Securities and Exchange Commission, press releases, public conference calls, the Company’s website (www.athira.com), its investor relations website (investors.athira.com), and its news site (investors.athira.com/news-and-events/press-releases). The Company uses these channels, as well as social media, including its Twitter account (@athirapharma), LinkedIn account (www.linkedin.com/company/athirapharma), and Facebook page (www.facebook.com/athirapharmainc), to communicate with investors and the public about the Company, its product candidates, and other matters. Therefore, the Company encourages investors, the media, and others interested in the Company to review the information it makes public in these locations, as such information could be deemed to be material information.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (formatted as Inline XBRL) |
The information furnished in this Current Report under Items 2.02 and 7.01 and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Athira Pharma, Inc. |
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Date: |
May 12, 2022 |
By: |
/s/ Mark Litton |
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Mark Litton |
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President and Chief Executive Officer |
Exhibit 99.1
Athira Pharma Reports First Quarter 2022 Financial Results
and Provides Pipeline and Business Updates
On track to report topline data from ACT-AD Phase 2 Alzheimer’s disease study by end of 2Q22
BOTHELL, WA, May 12, 2022 — Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced the company’s financial resumlts for the quarter ended March 31, 2022 and provided pipeline and business updates.
“Throughout the first quarter of 2022 we made significant progress advancing our strategy across Athira’s clinical development programs, with a focus on bringing our lead drug candidate, fosgonimeton, and the other molecules in our pipeline to patients while continuing to create lasting shareholder value,” stated Mark Litton, Ph.D., MBA, President and Chief Executive Officer of Athira. “During the first quarter, we published and presented a growing body of clinical and preclinical evidence in support of targeting the HGF/MET neurotrophic system. We were pleased to initiate two new studies in the first quarter: the Phase 2 SHAPE study of fosgonimeton in Parkinson’s disease dementia and Dementia with Lewy Bodies and a Phase 1 study of ATH-1020 to evaluate its safety, tolerability, and pharmacokinetics in healthy volunteers.”
“In addition to our considerable clinical progress, we advanced our corporate strategy through the expansion of our senior management team, as well as the expansion of our Board of Directors with two talented industry leaders – Grant Pickering, a proven life sciences leader with over 30 years of experience across all stages of corporate and clinical development, and Dr. Michael Panzara, an industry veteran with more than 20 years of CNS drug development and commercialization experience.
“We are looking forward to reporting topline data from our Phase 2 ACT-AD study in Alzheimer’s disease by the end of 2Q22 as we expect to gain insights into the safety and efficacy of our novel intervention as well as optimize the analysis plan for our potentially pivotal LIFT-AD study. We continue to advance these important studies in order to bring this potentially transformative medicine to the millions of patients impacted by Alzheimer’s disease,” concluded Dr. Litton.
First Quarter and Recent Highlights:
Pipeline Update:
Fosgonimeton (ATH-1017) is a small molecule specifically designed to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET.
ACT-AD Phase 2 Study in mild-to-moderate Alzheimer’s disease (NCT04491006)
LIFT-AD Phase 3 Study in mild-to-moderate Alzheimer’s Disease (NCT04488419)
Open Label Extension Study (NCT04886063)
SHAPE Phase 2 Study in Parkinson’s disease dementia and Dementia with Lewy bodies (NCT04831281)
ATH-1020 is a novel, orally available, brain-penetrant small molecule designed to enhance the HGF/MET system that is being advanced as a potential treatment candidate for neuropsychiatric indications.
Phase 1 Study in Healthy Volunteers (NCT05169671)
Preclinical Data of novel HGF/MET positive modulators (ATH-1018 and ATH-1019) to be presented at Peripheral Nerve Society (PNS) 2022 Annual Meeting
Financial Results
About Athira Pharma, Inc.
Athira Pharma Inc., headquartered in the Seattle area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to provide rapid cognitive improvement and alter the course of neurological diseases with its novel mechanism of action. Athira is currently advancing its pipeline of therapeutic candidates, targeting the HGF/MET neurotrophic system, for Alzheimer’s and Parkinson’s disease dementia, Dementia with Lewy bodies, and neuropsychiatric and peripheral indications. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn and @athirapharma on Twitter and Instagram.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding fosgonimeton as a potential treatment for Alzheimer’s disease, Parkinson’s disease dementia, Dementia with Lewy bodies, and other dementias, and ATH-1020 as a potential treatment for neuropsychiatric indications; Athira’s platform technology and potential therapies; future
development plans; clinical and regulatory objectives and the timing thereof, including the timing of the LIFT-AD and ACT-AD clinical trials and the timing of the Phase 2 clinical trial of fosgonimeton for treatment of Parkinson’s disease dementia and Dementia with Lewy bodies; interactions with regulators and the timing thereof, including anticipated timing of IND or equivalent submissions; expectations regarding the potential efficacy and commercial potential of Athira’s product candidates; the anticipated reporting of data; and Athira’s ability to advance its product candidates into later stages of development. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “on track,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” “continue,” and other similar expressions, among others. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the preliminary data for Athira’s fosgonimeton product candidate from the Phase 1a/b trials will not continue or persist in current or planned clinical trials; cessation or delay of any of the ongoing clinical trials and/or Athira’s development of fosgonimeton and other product candidates may occur; future potential regulatory milestones of our product candidates, including those related to current and planned clinical studies may be insufficient to support regulatory submissions or approval; the impact of the COVID-19 pandemic on Athira’s business, research and clinical development plans and timelines and results of operations, including impact on Athira’s clinical trial sites and contractors who act for or on Athira’s behalf, may be more severe and more prolonged than currently anticipated; the regulatory process for Athira product candidates; the outcome of legal proceedings which have been or may in the future be instituted against us and certain of our directors and officers; clinical trials may not demonstrate safety and efficacy of any of Athira’s product candidates; Athira’s assumptions regarding the sufficiency of its cash, cash equivalents and investments to fund its planned operations may be incorrect; Athira’s research and development efforts and its ability to advance product candidates into later stages of development may fail; any one or more of Athira’s product candidates may not be successfully developed, approved or commercialized; adverse conditions in the general domestic and global economic markets; the impact of competition; while P300 latency is a functional measure that is highly correlated with cognition, Athira may not successfully establish a connection between these P300 latency results and improved cognition; regulatory agencies may be delayed in reviewing, commenting on or approving any of Athira’s clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; as well as the other risks detailed in Athira’s filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Athira undertakes no obligation to update forward-looking statements. Athira may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements.
Investor & Media Contact:
Julie Rathbun
Athira Pharma
Julie.rathbun@athira.com
206-769-9219
Athira Pharma, Inc.
Condensed Consolidated Balance Sheets
(Amounts in thousands)
(Unaudited)
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March 31, |
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December 31, |
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2022 |
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2021 |
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Assets |
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Cash and cash equivalents |
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$ |
117,811 |
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$ |
110,537 |
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Short-term investments |
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145,715 |
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143,222 |
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Other short-term assets |
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5,628 |
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7,040 |
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Long-term investments |
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37,644 |
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65,936 |
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Other long-term assets |
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6,204 |
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5,273 |
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Total assets |
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$ |
313,002 |
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$ |
332,008 |
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Liabilities and stockholders' equity |
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Current liabilities |
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$ |
9,471 |
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$ |
9,292 |
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Long-term liabilities |
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1,554 |
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1,632 |
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Total liabilities |
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11,025 |
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10,924 |
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Stockholders' equity |
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301,977 |
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321,084 |
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Total liabilities and stockholders' equity |
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$ |
313,002 |
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$ |
332,008 |
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Athira Pharma, Inc.
Condensed Consolidated Statement of Comprehensive Loss
(Amounts in thousands, except share and per share amounts)
(Unaudited)
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Year Ended December 31, |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
14,460 |
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$ |
7,445 |
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General and administrative |
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$ |
8,927 |
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$ |
3,336 |
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Total operating expenses |
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23,387 |
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10,781 |
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Loss from operations |
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(23,387 |
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(10,781 |
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Grant income |
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2,234 |
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1,831 |
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Other income, net |
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173 |
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84 |
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Net loss |
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$ |
(20,980 |
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$ |
(8,866 |
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Unrealized loss on available-for-sale securities |
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(1,068 |
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(5 |
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Comprehensive loss attributable to common stockholders |
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$ |
(22,048 |
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$ |
(8,871 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.56 |
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$ |
(0.25 |
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Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
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37,593,328 |
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35,775,454 |
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