LONA 8-K
LeonaBio, Inc. (LONA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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Securities registered pursuant to Section 12(b) of the Act:
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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 August 15, 2022, Athira Pharma, Inc. (the “Company”) issued a press release reporting its financial results for the quarter ended June 30, 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: |
August 15, 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 Second Quarter 2022 Financial Results and Recent Clinical and Corporate Updates
Presented clinical and preclinical data at Alzheimer’s Association International Conference 2022
Strong balance sheet to support clinical development pipeline
BOTHELL, WA, August 15, 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 results for the second quarter ended June 30, 2022 and reviewed recent clinical and corporate updates.
“We are encouraged by the biologic activity and safety topline results from the ACT-AD trial in Alzheimer’s disease. While the primary endpoint did not reach statistical significance, the trial results are the first ever to show potential cognitive improvement through positive modulation of the HGF/MET receptor by fosgonimeton. This is an important achievement supporting our conviction that we have a unique opportunity to reshape the course of neurodegenerative diseases,” stated Mark Litton, Ph.D., President and Chief Executive Officer of Athira.
“The growing body of clinical and preclinical data with fosgonimeton and our other novel HGF/MET positive modulators support the potential for this pathway to improve neuronal health in a number of neurodegenerative diseases. Importantly, we are pleased to have a strong balance sheet that can support our programs through a number of key inflection points,” concluded Dr. Litton.
Clinical 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 an 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)
Research and Development Update:
Preclinical Data Presented at Alzheimer's Association International Conference 2022
Preclinical Data Presented at Peripheral Nerve Society (PNS) 2022 Annual Meeting
Corporate Update:
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 lead therapeutic candidate, fosgonimeton, a novel small molecule for Alzheimer’s and Parkinson’s disease dementia and Dementia with Lewy bodies. 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; 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 clinical trial, the Phase 2 clinical trial of fosgonimeton for treatment of Parkinson’s disease dementia and the Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of ATH-1020; 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; the potential learnings from the ACT-AD clinical trial and their ability to inform and improve future clinical development plans; anticipated sufficiency of cash resources; 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 data for our product candidates from our preclinical and clinical trials will not support the safety, efficacy and tolerability of our product candidates; cessation or delay of any of the ongoing clinical trials and/or Athira’s development of fosgonimeton and other product candidates may occur; Athira may not be able to recruit sufficient patients for its clinical trials; future potential regulatory milestones of fosgonimeton and other 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 the regulatory process for Athira’s 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; possible negative interactions of Athira’s product candidates with other treatments; 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; 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
206-769-9219
Athira Pharma, Inc.
Condensed Consolidated Balance Sheets
(Amounts in thousands)
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June 30, |
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December 31, |
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2022 |
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2021 |
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(unaudited) |
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Assets |
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Cash and cash equivalents |
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$ |
95,057 |
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$ |
110,537 |
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Short-term investments |
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157,347 |
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143,222 |
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Other short-term assets |
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3,456 |
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7,040 |
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Long-term investments |
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29,844 |
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65,936 |
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Other long-term assets |
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6,307 |
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5,273 |
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Total assets |
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$ |
292,011 |
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$ |
332,008 |
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Liabilities and stockholders' equity |
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Current liabilities |
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$ |
9,692 |
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$ |
9,292 |
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Long-term liabilities |
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1,754 |
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1,632 |
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Total liabilities |
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11,446 |
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10,924 |
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Stockholders' equity |
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280,565 |
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321,084 |
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Total liabilities and stockholders' equity |
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$ |
292,011 |
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$ |
332,008 |
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Athira Pharma, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(Amounts in thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended June 30, |
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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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$ |
14,803 |
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$ |
12,024 |
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General and administrative |
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$ |
8,766 |
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$ |
4,613 |
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Total operating expenses |
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23,569 |
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16,637 |
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Loss from operations |
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(23,569 |
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(16,637 |
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Grant income |
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(1,259) |
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2,589 |
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Other income, net |
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493 |
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74 |
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Net loss |
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$ |
(24,335 |
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$ |
(13,974 |
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Unrealized (loss) gain on available-for-sale securities |
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(469 |
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9 |
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Comprehensive loss attributable to common stockholders |
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$ |
(24,804 |
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$ |
(13,965 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.65 |
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$ |
(0.38 |
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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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37,667,971 |
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37,214,602 |
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