Full Press Release Details
Athira Pharma Reports First Quarter 2021 Financial Results and Provides Business Highlights
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BOTHELL, WASHINGTON, May 13, 2021 - Athira Pharma, Inc. (NASDAQ: ATHA) ("Athira"), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration, today reported financial results for the quarter ended March 31, 2021 and provided recent business highlights.
"We continue to execute on our corporate and clinical goals during this very important time in Athira's history," said Leen Kawas, Ph.D., President and Chief Executive Officer at Athira. "Our clinical trials, ACT-AD and LIFT-AD, are actively enrolling and will evaluate the clinical utility of ATH-1017 to treat Alzheimer's disease and improve cognitive health. In addition to developing ATH-1017 in Alzheimer's disease, we plan to evaluate it in Parkinson's disease dementia. We also remain committed to advancing our expanding pipeline of novel, small molecule compounds. We have a well-defined strategic plan ahead of us and are well-funded to reach multiple clinical and regulatory milestones."
Recent Business Highlights and Anticipated Milestones
ATH-1017: A small molecule therapeutic specifically designed to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET, which are expressed in normal central nervous system function, in order to impact neurodegeneration and regenerate brain tissue.
ATH-1019/1020: Novel, small molecule compounds designed to be orally available once-daily treatments, to activate the HGF/MET system and to distribute to the central nervous system as potential candidates for neuropsychiatric indications, including depression, anxiety and potentially schizophrenia.
First Quarter 2021 Financial Results
About Athira Pharma, Inc.
Athira, headquartered in the Seattle area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration. We aim to provide rapid cognitive improvement and alter the course of neurological diseases with our novel mechanism of action. Athira is currently advancing its lead therapeutic candidate, ATH-1017, a novel small molecule for Alzheimer's and Parkinson's dementia. 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 ATH-1017 as a potential treatment for Alzheimer's disease and other dementias; Athira's platform technology and potential therapies; future development plans; clinical and regulatory objectives and the timing thereof, including the timing of the ACT-AD and LIFT-AD clinical trials and filing of INDs for the initiation of trials in PDD and a neuropsychiatric indication; anticipated design of planned clinical trials; expectations regarding the potential efficacy and commercial potential of Athira's product candidates, including ATH-1017 and ATH-1019/1020; the anticipated presentation of data; the results of Athira's research and development efforts; 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 and phrases such as "may," "will," "should," "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 ATH-1017 product candidate from the Phase 1a/b trials will not continue or persist; cessation or delay of any of the ongoing clinical trials and/or Athira's development of ATH-1017 may occur; future potential regulatory milestones of ATH-1017, 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, clinical trials may not demonstrate safety and efficacy of any of Athira's product candidates; Athira's assumptions regarding its planned expenditures and sufficiency of its cash, cash equivalents and investments to fund 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; regulatory uncertainty as a result of the new U.S. administration; 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 competition; the impact of expanded product development and clinical activities on operating expenses; 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.
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Condensed Consolidated Balance Sheets
(Amounts in thousands)
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 127,823 | $ | 60,625 | ||||
| Short-term investments | 176,367 | 124,057 | ||||||
| Other short-term assets | 7,378 | 7,655 | ||||||
| Long-term investments | 53,467 | 83,509 | ||||||
| Other long-term assets | 4,379 | 3,717 | ||||||
| Total assets | $ | 369,414 | $ | 279,563 | ||||
| Liabilities stockholders' equity | ||||||||
| Current liabilities | $ | 4,497 | $ | 4,405 | ||||
| Long-term liabilities | 1,700 | 876 | ||||||
| Total liabilities | 6,197 | 5,281 | ||||||
| Stockholders' equity | 363,217 | 274,282 | ||||||
| Total liabilities and stockholders' equity | $ | 369,414 | $ | 279,563 |
Condensed Consolidated Statements of Comprehensive Loss
(Amounts in thousands)
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 7,445 | $ | 592 | ||||
| General and administrative | $ | 3,336 | $ | 675 | ||||
| Total operating expenses | 10,781 | 1,267 | ||||||
| Loss from operations | (10,781 | ) | (1,267 | ) | ||||
| Grant income | 1,831 | 22 | ||||||
| Other income (expense), net | 84 | (560 | ) | |||||
| Net loss | $ | (8,866 | ) | $ | (1,805 | ) | ||
| Unrealized (loss) on available-for-sale securities | (5 | ) | - | |||||
| Comprehensive loss attributable to common shareholders | $ | (8,871 | ) | $ | (1,805 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.25 | ) | $ | (0.48 | ) | ||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 35,775,454 | 3,747,356 |