LONA 8-K
LeonaBio, Inc. (LONA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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 March 23, 2023, Athira Pharma, Inc. (the “Company”) issued a press release reporting its financial results for the year ended December 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: |
March 23, 2023 |
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 Full Year 2022 Financial Results and Recent Pipeline and Business Updates
On track to complete enrollment in Phase 2/3 LIFT-AD trial of fosgonimeton for mild-to-moderate Alzheimer’s disease in mid-2023 with topline data in early 2024
Continuing to advance development of ATH-1105 as a potential clinical candidate for amyotrophic lateral sclerosis
Strong balance sheet to support innovative clinical development pipeline in neurodegenerative diseases through key inflection points
BOTHELL, Wash., March 23, 2023 – 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 year ended December 31, 2022, and reviewed recent pipeline and business updates.
“The progress we made throughout 2022 and in recent months continues to support our strategy to advance our small molecule therapeutic candidates, such as fosgonimeton, to impact neurodegenerative diseases, as both clinical and preclinical data suggest potential neuroprotective, neurotrophic, anti-inflammatory, procognitive and disease-modifying effects,” stated Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “Furthermore, recent and upcoming presentations at medical and scientific meetings provide the opportunity to highlight our diverse and robust clinical and preclinical data supporting the therapeutic potential of enhancing the HGF/MET system in a variety of neurodegenerative diseases including Alzheimer’s disease, Parkinson’s disease and ALS.
“We believe the independent, unblinded interim efficacy and futility analysis of the Phase 2/3 LIFT-AD trial reported in October 2022 mitigates fosgonimeton program risk, supports the potential clinical benefits of fosgonimeton treatment, and underscores the rationale for continued development of this promising potential new therapy for mild-to-moderate Alzheimer’s disease. We are targeting to complete enrollment of the LIFT-AD trial in mid-2023 and to have topline data in early 2024. Additionally, we continue to advance IND-enabling studies with ATH-1105 and expect to initiate a Phase 1 study in 2024 to evaluate its potential as a treatment for ALS.
“We ended 2022 with a strong balance sheet that enables us to continue to explore the potential of fosgonimeton in Alzheimer’s and to advance our other pipeline candidates in neurodegenerative diseases, such as ATH-1105 in ALS, through key inflection points,” concluded Dr. Litton.
Recent Highlights
Clinical Development & Pipeline Programs
Fosgonimeton (ATH-1017) - Small molecule designed to enhance the activity of the HGF/MET system with the potential to protect and repair neuronal networks.
LIFT-AD phase 2/3 trial in mild-to-moderate Alzheimer’s disease (NCT04488419)
Open Label Extension (OLEX) trial (NCT04886063)
SHAPE phase 2 trial in mild-to-moderate Parkinson’s disease dementia and dementia with Lewy bodies (NCT04831281)
ATH-1020 - Orally available, novel small molecule compound designed to enhance the HGF/MET system, as a potential treatment candidate for neuropathic pain or other neurodegenerative diseases.
Phase 1 trial in healthy volunteers (NCT05169671)
ATH-1105 – A novel small molecule compound designed to be a positive modulator of the HGF/MET system as a potential treatment candidate for amyotrophic lateral sclerosis (ALS).
Financial Results
About Athira Pharma, Inc.
Athira Pharma, Inc., headquartered in the Seattle, Washington 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 therapeutic candidates targeting the HGF/MET neurotrophic system for Alzheimer’s and Parkinson’s disease, Dementia with Lewy bodies and ALS. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn, Twitter and @athirapharma on Instagram.
Forward-Looking Statements
This communication 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: product candidates as a potential treatment for Alzheimer’s disease, Parkinson’s disease dementia, Dementia with Lewy bodies, neuropsychiatric diseases, and other neurodegenerative diseases, such as amyotrophic lateral sclerosis; Athira’s platform technology and potential therapies; future development plans; clinical and regulatory objectives and the timing thereof; expectations regarding the potential efficacy and commercial potential of Athira’s product candidates; the anticipated reporting of data; the potential learnings from the LIFT-AD
unblinded interim efficacy and futility analysis and their ability to inform and improve future clinical
development plans; 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,” “suggest,” “potential,” 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 not supporting the safety, efficacy and tolerability of our product candidates; cessation or delay of Athira’s development of product candidates may occur; regulatory authorities could object to protocols, amendments and other
submissions; future potential regulatory milestones for 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 product candidates; Athira may not be able to recruit sufficient patients for its clinical trials; the outcome of legal proceedings that 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; 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
[email protected]
206-769-9219
Athira Pharma, Inc.
Condensed Consolidated Balance Sheets
(Amounts in thousands)
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December 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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$ |
95,966 |
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$ |
110,537 |
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Short-term investments |
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104,378 |
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143,222 |
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Other short-term assets |
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7,189 |
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7,040 |
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Long-term investments |
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44,829 |
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65,936 |
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Other long-term assets |
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5,791 |
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5,273 |
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Total assets |
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$ |
258,153 |
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$ |
332,008 |
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Liabilities and stockholders' equity |
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Current liabilities |
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$ |
21,431 |
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$ |
9,292 |
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Long-term liabilities |
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1,585 |
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1,632 |
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Total liabilities |
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23,016 |
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10,924 |
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Stockholders' equity |
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235,137 |
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321,084 |
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Total liabilities and stockholders' equity |
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$ |
258,153 |
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$ |
332,008 |
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Athira Pharma, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except share and per share amounts)
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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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$ |
61,464 |
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$ |
42,794 |
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General and administrative |
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32,552 |
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21,228 |
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Legal settlement |
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10,000 |
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— |
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Total operating expenses |
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104,016 |
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64,022 |
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Loss from operations |
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(104,016 |
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(64,022 |
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Grant income |
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5,161 |
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8,835 |
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Other income, net |
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3,216 |
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334 |
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Net loss |
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$ |
(95,639 |
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$ |
(54,853 |
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Unrealized loss on available-for-sale securities |
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(1,568 |
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(421 |
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Comprehensive loss attributable to common stockholders |
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$ |
(97,207 |
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$ |
(55,274 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(2.53 |
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$ |
(1.49 |
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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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37,733,240 |
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36,921,172 |
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