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 10, 2023, Athira Pharma, Inc. (the “Company”) issued a press release reporting its financial results for the quarter ended June 30, 2023. 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), Instagram account (@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 10, 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 Second Quarter 2023 Financial Results and Pipeline and Business Updates
Completed end of Phase 2 meeting and continued engagement with U.S. Food and Drug Administration
Appointed Andrew Gengos as Chief Financial Officer and Chief Business Officer
Maintains strong balance sheet to support innovative clinical development pipeline in neurodegenerative diseases through key inflection points
BOTHELL, Wash., August 10, 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 reported financial results for the quarter ended June 30, 2023, and provided pipeline and business updates.
“During the second quarter, we advanced and strengthened our pipeline of small molecule therapeutic candidates, with particular focus on continued enrollment of the Phase 2/3 LIFT-AD trial of investigational fosgonimeton for the treatment of mild-to-moderate Alzheimer’s disease and advancement of our preclinical ATH-1105 program toward clinical testing, initially targeting amyotrophic lateral sclerosis,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “At the July Alzheimer’s Association International Conference, we presented new findings regarding both our fosgonimeton and ATH-1105 programs. These data, along with the totality of evidence generated to date, strengthen our view that our pipeline of drug candidates, which are designed to positively modulate the HGF/MET neurotrophic system, have the potential to deliver novel treatments for neurodegenerative diseases.”
“Our end of Phase 2 meeting with the U.S. Food and Drug Administration was very productive and enabled alignment with senior leadership from the Office of Neuroscience and Division of Neurology 1 on important aspects of the fosgonimeton program. We look forward to continued communication with the FDA including discussions regarding our biomarker strategy and the LIFT-AD results, now expected in the second half of 2024,” concluded Dr. Litton.
Clinical Development & Pipeline Programs
Fosgonimeton (ATH-1017) – Small molecule designed to enhance the HGF/MET system with the potential to protect and repair neuronal networks.
End of Phase 2 Meeting (EOP2) with the U.S. Food and Drug Administration (FDA)
LIFT-AD Phase 2/3 trial in mild-to-moderate Alzheimer’s disease (NCT04488419)
Open Label Extension (OLEX) trial (NCT04886063)
ATH-1105 – A novel, orally available, small molecule designed to be a positive modulator of the HGF/MET system as a potential treatment candidate initially for amyotrophic lateral sclerosis (ALS).
Presentations and Publications
In July, the Company presented three posters at the Alzheimer’s Association International Conference 2023 (AAIC) that highlighted its pipeline of small molecule therapeutic candidates targeting HGF/MET. Data presented included:
Corporate Updates
The Company appointed seasoned finance and corporate strategy executive Andrew Gengos as Chief Financial Officer and Chief Business Officer.
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 alter the course of neurological disease by advancing its pipeline of therapeutic candidates targeting the HGF/MET neurotrophic system for Alzheimer’s and Parkinson’s disease, Dementia with Lewy bodies, and amyotrophic lateral sclerosis. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn and @athirapharma on X, formerly known as Twitter, and 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 and other neurodegenerative diseases, such as amyotrophic lateral sclerosis and frontotemporal dementia; Athira’s platform technology and potential therapies; future development plans; expectations regarding the potential efficacy and commercial potential of Athira’s product candidates; the anticipated reporting of data; the impact of Athira’s July 2023 End of Phase 2 Metting with the U.S. Food and Drug Administration on its future development plans and pipeline candidates; 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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June 30, |
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December 31, |
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2023 |
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2022 |
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(unaudited) |
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Assets |
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Cash and cash equivalents |
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$ |
113,628 |
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$ |
95,966 |
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Short-term investments |
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72,462 |
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104,378 |
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Other short-term assets |
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6,043 |
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7,189 |
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Long-term investments |
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10,217 |
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44,829 |
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Other long-term assets |
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5,698 |
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5,791 |
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Total assets |
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$ |
208,048 |
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$ |
258,153 |
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Liabilities and stockholders' equity |
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Current liabilities |
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$ |
21,662 |
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$ |
21,431 |
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Long-term liabilities |
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1,407 |
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1,585 |
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Total liabilities |
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23,069 |
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23,016 |
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Stockholders' equity |
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184,979 |
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235,137 |
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Total liabilities and stockholders' equity |
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$ |
208,048 |
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$ |
258,153 |
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Athira Pharma, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended |
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2023 |
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2022 |
Operating expenses: |
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Research and development |
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$ 21,615 |
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$ 14,803 |
General and administrative |
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10,025 |
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8,766 |
Total operating expenses |
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31,640 |
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23,569 |
Loss from operations |
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(31,640) |
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(23,569) |
Grant income |
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— |
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(1,259) |
Other income, net |
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2,043 |
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493 |
Net loss |
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$ (29,597) |
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$ (24,335) |
Unrealized gain (loss) on available-for-sale securities |
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90 |
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(469) |
Comprehensive loss attributable to common stockholders |
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$ (29,507) |
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$ (24,804) |
Net loss per share attributable to common stockholders, |
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$ (0.78) |
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$ (0.65) |
Weighted-average shares used in computing net loss per |
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37,999,578 |
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37,667,971 |