LONA 8-K
LeonaBio, Inc. (LONA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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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 November 9, 2023, Athira Pharma, Inc. (the “Company”) issued a press release reporting its financial results for the quarter ended September 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 X account (formerly known as Twitter)(@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: |
November 9, 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 Third Quarter 2023 Financial Results and Pipeline and Business Updates
Continues to report clinical and preclinical findings supporting the potential benefits of its small molecule therapeutic candidates targeting the neurotrophic HGF system as potential novel treatments for neurodegenerative diseases
Expects to complete enrollment of Phase 2/3 LIFT-AD clinical trial of fosgonimeton in mild-to-moderate Alzheimer’s disease patients by the first quarter of 2024 with topline data expected in second half 2024
Maintains strong balance sheet to support innovative clinical development pipeline through key inflection points
BOTHELL, Wash., November 9, 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 September 30, 2023, and provided pipeline and business updates.
“We enter the balance of the year more encouraged than ever by our increasing understanding of the power of modulating the neurotrophic HGF system as a potential strategy for treating a wide range of neurodegenerative diseases. Our pipeline of small molecule HGF system modulators has the potential to become the basis of a future product line of neurodegenerative disease treatments,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “During the third quarter and recent weeks, we continued to present new data at key medical meetings that provide further evidence supporting the promise of both our fosgonimeton and ATH-1105 programs, and neurotrophic HGF system modulation in general, to modify the disease course for patients across a broad range of neurodegenerative diseases, including Alzheimer's disease (AD) and amyotrophic lateral sclerosis (ALS). We believe we have a leading position in understanding the neurotrophic HGF system biology.”
“We remain keenly focused on advancing the ongoing Phase 2/3 LIFT-AD study, where we have added clinical sites and continued to engage with investigators to ensure completion of enrollment of this important study by the first quarter of 2024. This summer, we had a productive end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) which enabled alignment with the FDA 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 topline results, which are expected in the second half of 2024,” concluded Dr. Litton.
Clinical Development & Pipeline Programs
Athira’s drug development pipeline consists of potential first-in-class (fosgonimeton) and next-generation (ATH-1105 and ATH-1020) small molecule therapeutic candidates designed to promote the neurotrophic HGF system, which activates neuroprotective, neurotrophic and anti-inflammatory pathways in the central nervous system. Athira’s therapeutic candidates have distinct properties which the Company believes may be applicable to a range of neurodegenerative diseases.
Fosgonimeton (ATH-1017) – A potentially first-in-class, once daily, subcutaneously administered drug candidate initially targeted to the potential treatment of Alzheimer’s.
LIFT-AD Phase 2/3 trial of fosgonimeton in mild-to-moderate Alzheimer’s disease (NCT04488419)
Open Label Extension (OLEX) fosgonimeton trial (NCT04886063)
ATH-1105 – A next-generation, orally administered drug candidate developed for the potential treatment of amyotrophic lateral sclerosis (ALS) as the Company’s initial indication.
Recent and Upcoming Presentations
Athira continues to expand the body of clinical and preclinical findings supporting the potential benefits of its pipeline of small molecule therapeutic candidates targeting the neurotrophic HGF system to deliver novel treatments for neurodegenerative diseases.
The Company presented new data at the Alzheimer’s Association International Conference 2023 (AAIC) that included:
The Company presented preclinical data that further supports the potential of fosgonimeton to treat neurodegenerative diseases such as AD at the 16th Annual Clinical Trials on Alzheimer’s Disease conference (CTAD). The data presented:
The Company presented preclinical data demonstrating the neuroprotective properties of ATH-1105 in several preclinical models of ALS at the 22nd Annual Northeast ALS Consortium (NEALS) Meeting that demonstrated:
Athira will be presenting new preclinical data supporting the potential therapeutic benefit of fosgonimeton for the treatment of Alzheimer’s disease at Neuroscience 2023. The event is hosted by the Society for Neuroscience and will take place at the Walter E. Washington Convention Center in Washington, D.C., November 11-15, 2023.
Presentation Details:
Title: Fosgonimeton, a small-molecule positive modulator of the neurotrophic HGF system, protects against amyloid beta-induced pathological alterations in Alzheimer's disease models in vitro and in vivo
Format: Oral Nanosymposium
Session: NAN076
Development of Novel Therapies for Neurodegenerative and Neuromuscular Diseases
Presenter: Sharay Setti, PhD, Senior Scientist, Athira Pharma
Time/Date: Wednesday, November 15, Session time: 8:00 a.m. – 12:00 p.m. Eastern Time, Presentation time: 8:15 a.m. – 8:30 am. Eastern Time
Title: Fosgonimeton, a small-molecule positive modulator of the neurotrophic hepatocyte growth factor system, inhibits LPS-mediated neuroinflammation in BV2 microglia
Format: Poster
Session: PSTR 203.06. Neuroinflammation: Microglia
Presenter: Wei Wu, PhD, Senior Scientist II, Athira Pharma
Time/Date: Monday, November 13, Session time: 8:00 a.m. – 12:00 p.m. Eastern Time, Presentation time: 9:00 a.m. – 10:00 a.m. Eastern Time
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 diseases by advancing its pipeline of
therapeutic candidates that modulate the neurotrophic HGF system. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn, 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 neurodegenerative diseases such as Alzheimer’s disease and amyotrophic lateral sclerosis; 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 Meeting 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 similar expressions. 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 from preclinical and clinical trials may not support the safety, efficacy and tolerability of Athira’s product candidates; development of product candidates may cease or be delayed; 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; 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 Athira, its directors and officers; 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 pandemics or health epidemics, 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 from time to time. 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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September 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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$ |
110,334 |
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$ |
95,966 |
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Short-term investments |
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62,614 |
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104,378 |
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Other short-term assets |
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5,556 |
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7,189 |
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Long-term investments |
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— |
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44,829 |
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Other long-term assets |
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6,196 |
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5,791 |
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Total assets |
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$ |
184,700 |
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$ |
258,153 |
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Liabilities and stockholders' equity |
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Current liabilities |
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$ |
28,622 |
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$ |
21,431 |
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Long-term liabilities |
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1,314 |
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1,585 |
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Total liabilities |
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29,936 |
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23,016 |
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Stockholders' equity |
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154,764 |
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235,137 |
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Total liabilities and stockholders' equity |
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$ |
184,700 |
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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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$ 27,202 |
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$ 16,965 |
General and administrative |
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7,840 |
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7,168 |
Total operating expenses |
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35,042 |
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24,133 |
Loss from operations |
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(35,042) |
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(24,133) |
Grant income |
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— |
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2,959 |
Other income, net |
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2,072 |
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985 |
Net loss |
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$ (32,970) |
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$ (20,189) |
Unrealized gain (loss) on available-for-sale securities |
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261 |
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(547) |
Comprehensive loss attributable to common stockholders |
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$ (32,709) |
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$ (20,736) |
Net loss per share attributable to common stockholders, |
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$ (0.87) |
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$ (0.53) |
Weighted-average shares used in computing net loss per |
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38,054,583 |
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37,817,724 |