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Athira Pharma(ATHA) - 2021 Q1 - Quarterly Report
Athira PharmaAthira Pharma(US:ATHA)2021-05-12 16:00

PART I. FINANCIAL INFORMATION Financial Statements (Unaudited) Athira Pharma's Q1 2021 unaudited financials show cash and investments increased to $357.7 million, with a net loss of $8.9 million due to higher expenses Condensed Consolidated Balance Sheets As of March 31, 2021, total assets increased to $369.4 million and stockholders' equity to $363.2 million, primarily due to a follow-on public offering Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $127,823 | $60,625 | | Short-term investments | $176,367 | $124,057 | | Total current assets | $311,568 | $192,337 | | Total assets | $369,414 | $279,563 | | Liabilities & Stockholders' Equity | | | | Total liabilities | $6,197 | $5,281 | | Total stockholders' equity | $363,217 | $274,282 | | Total liabilities and stockholders' equity | $369,414 | $279,563 | Condensed Consolidated Statements of Operations and Comprehensive Loss For Q1 2021, the company reported a net loss of $8.9 million, up from $1.8 million in Q1 2020, driven by increased R&D and G&A expenses Condensed Consolidated Statements of Operations (in thousands) | Account | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | 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 | | Net loss | ($8,866) | ($1,805) | | Net loss per share, basic and diluted | ($0.25) | ($0.48) | Condensed Consolidated Statements of Cash Flows In Q1 2021, operating activities used $7.3 million, investing activities used $22.7 million, and financing activities provided $97.2 million, leading to a $67.2 million net cash increase Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($7,305) | ($1,175) | | Net cash (used in) provided by investing activities | ($22,708) | $1 | | Net cash provided by financing activities | $97,211 | $1,840 | | Net increase in cash and cash equivalents | $67,198 | $666 | | Cash and cash equivalents, end of period | $127,823 | $2,722 | - The primary source of cash from financing activities in Q1 2021 was $97.2 million in net proceeds from the follow-on public offering and stock option exercises138 Notes to Unaudited Condensed Consolidated Financial Statements The notes detail the company's biopharmaceutical business, significant financing activities including a January 2021 follow-on offering, accounting policies, and confirm funding for at least the next 12 months - In January and February 2021, the company completed a follow-on public offering, selling a total of 4,600,000 shares and raising approximately $96.8 million in net proceeds21111 - The company received a grant from the National Institute on Aging (NIA) of the NIH, which could provide up to $15.2 million to support the ACT-AD Phase 2 clinical trial for ATH-1017. In Q1 2021, $1.831 million was recognized as grant income from this source3029 - Based on its current operating plan, the company estimates its cash, cash equivalents, and investments of $357.7 million as of March 31, 2021, are sufficient to fund operations for at least the next 12 months23109 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's focus on neurodegeneration with lead candidate ATH-1017, highlighting increased operating expenses from clinical trials and a strong financial position with $357.7 million in cash, expected to fund operations through at least 2022 - The company is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration. Its lead candidate, ATH-1017, is being evaluated in two trials for mild-to-moderate Alzheimer's disease: the LIFT-AD Phase 2/3 trial and the ACT-AD Phase 2 trial9597 Anticipated Upcoming Milestones | Program (RoA) | Indication | Anticipated Upcoming Milestones | | :--- | :--- | :--- | | ATH-1017 (SC) | Alzheimer's Disease | LIFT-AD topline data by end of 2022; ACT-AD topline data by early 2022 | | ATH-1017 (SC) | Parkinson's Disease Dementia | Phase 2 initiation by end of 2021 | | ATH-1019/20 (PO) | Neuropsychiatric Indications | IND filing by end of 2021 | | ATH-1018 (PO) | Peripheral Indications | IND filing by end of 2022 | Results of Operations In Q1 2021, total operating expenses increased from $1.3 million to $10.8 million, primarily due to higher R&D and G&A costs, leading to a net loss of $8.9 million versus $1.8 million in Q1 2020 Research and Development Expenses Breakdown (in thousands) | Category | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Direct costs: | | | | ATH-1017 | $6,188 | $349 | | Preclinical programs and other | $312 | $18 | | Indirect costs: | | | | Personnel-related costs | $852 | $176 | | Facilities and other costs | $93 | $49 | | Total R&D Expenses | $7,445 | $592 | - The increase in R&D expenses was primarily driven by a $5.8 million increase in costs for ATH-1017, related to start-up activities for Phase 2 clinical trials123 - General and administrative expenses increased by $2.6 million, mainly due to a $1.1 million increase in personnel costs from higher headcount, a $0.8 million increase in insurance costs, and a $0.4 million increase in facilities costs124 Liquidity and Capital Resources As of March 31, 2021, the company held $357.7 million in cash and investments, primarily from equity sales, sufficient to fund operations through at least 2022, with future funding needs for full development - As of March 31, 2021, the company had $357.7 million in cash, cash equivalents and investments106129 - The company estimates that its existing cash, cash equivalents and investments will be sufficient to fund its operating expenses and capital expenditure requirements at least through 2022109203 Recent Common Stock Sales (in millions) | Offering | Net Proceeds | | :--- | :--- | | September 2020 IPO | $186.4 | | October 2020 overallotment | $22.1 | | January 2021 follow-on | $84.1 | | February 2021 overallotment | $12.7 | | Total | $305.3 | Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Athira Pharma, Inc. is not required to provide market risk disclosures - The company is not required to provide information on this item as it qualifies as a smaller reporting company148 Controls and Procedures Management concluded the company's disclosure controls and procedures were effective as of March 31, 2021, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2021150 - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2021, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting151 PART II. OTHER INFORMATION Legal Proceedings The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business or financial condition - The company is not currently a party to or aware of any proceedings that are expected to have a material adverse effect on its business152 Risk Factors The company faces numerous risks, primarily its dependence on the success of lead candidate ATH-1017, lengthy clinical development, intense competition, historical losses, and the need for substantial additional funding - The company is a late clinical-stage biopharmaceutical company with a limited operating history, and its ability to generate revenue depends on the success of its objectives, particularly the development of ATH-10177154156 - The company's therapeutic approach of using small molecules to target brain growth factors is novel, and clinical data is limited to Phase 1a/1b trials involving only 11 Alzheimer's patients, with no certainty that future trials will yield similar results7162 - The company has incurred significant losses since inception and expects to continue incurring them for the foreseeable future, requiring substantial additional funding to complete development and commercialization7198202 - The company faces significant competition from larger pharmaceutical companies with greater financial resources and expertise in development, manufacturing, and commercialization7181 Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered equity sales and no material change in the planned use of IPO net proceeds during the period - There were no unregistered sales of equity securities in the reported period380 - There has been no material change in the planned use of proceeds from the company's IPO382 Exhibits This section lists exhibits filed with the quarterly report, including corporate documents, officer certifications, and XBRL data