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 May 11, 2023, Athira Pharma, Inc. (the “Company”) issued a press release reporting its financial results for the quarter ended March 31, 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), 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: |
May 11, 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 First Quarter 2023 Financial Results
and Recent Pipeline and Business Updates
Phase 2/3 LIFT-AD trial of fosgonimeton for mild-to-moderate Alzheimer’s disease to focus on 40 mg dose
Open label extension trial to be extended, providing up to 36 months of long-term exposure data
ATH-1105 significantly prolongs survival and improves motor function in a mouse model of ALS; Strongly supports development as a treatment for ALS
Strong balance sheet to support innovative clinical development pipeline in neurodegenerative diseases through key inflection points
BOTHELL, Wash., May 11, 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 first quarter ended March 31, 2023, and reviewed recent pipeline and business updates.
“We continue to advance the Phase 2/3 LIFT-AD trial of fosgonimeton as a treatment for mild-to-moderate Alzheimer’s disease and will focus on the 40 mg dose, as the totality of the data supports the selection of this dose to enhance both our chances for success and the trial’s potential to be a registrational study,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira.
“Throughout the first quarter and in the recent months, we presented supportive preclinical and clinical data describing the therapeutic potential of enhancing the HGF/MET system to protect and repair neuronal networks in neurodegenerative diseases such as Alzheimer’s (AD), Parkinson’s and amyotrophic lateral sclerosis (ALS). Clinical data recently presented at AAN showed a statistically significant improvement in Mini-Mental State Exam (MMSE) scores in the participants treated with fosgonimeton without concomitant acetylcholinesterase inhibitors (AChEIs) in a post-hoc analysis of the exploratory six-month Phase 2 ACT-AD trial. These data, along with a statistically significant improvement in a plasma biomarker of neurodegeneration (neurofilament light chain, NfL), and directional improvements in biomarkers of neuroinflammation and AD protein pathology continue to give us confidence in the potential for fosgonimeton to become a meaningful therapy for people living with Alzheimer’s.
“We have a strong balance sheet that enables us to continue to advance fosgonimeton in Alzheimer’s and ATH-1105 in ALS, through key inflection points,” 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.
LIFT-AD Phase 2/3 trial in mild-to-moderate Alzheimer’s disease (NCT04488419)
Open Label Extension (OLEX) trial (NCT04886063)
The ACT-AD trial and the related open-label extension for ACT-AD participants was supported by a grant from the National Institute on Aging of the National Institutes of Health under Award Number R01AG06268. The information presented in this press release is solely the responsibility of Athira and does not necessarily represent the official views of the National Institutes of Health.
Presentations and Publications
ATH-1105 – A novel, orally available, small molecule 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 safety, 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; Athira’s plans to further extend the open label extension trial for its LIFT-AD and ACT-AD clinical trials; 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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March 31, |
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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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$ |
105,182 |
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$ |
95,966 |
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Short-term investments |
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80,799 |
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104,378 |
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Other short-term assets |
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6,915 |
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7,189 |
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Long-term investments |
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33,903 |
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44,829 |
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Other long-term assets |
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5,973 |
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5,791 |
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Total assets |
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$ |
232,772 |
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$ |
258,153 |
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Liabilities and stockholders' equity |
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Current liabilities |
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$ |
20,150 |
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$ |
21,431 |
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Long-term liabilities |
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1,497 |
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1,585 |
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Total liabilities |
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21,647 |
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23,016 |
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Stockholders' equity |
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211,125 |
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235,137 |
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Total liabilities and stockholders' equity |
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$ |
232,772 |
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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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$ 21,293 |
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$ 14,460 |
General and administrative |
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8,477 |
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8,927 |
Total operating expenses |
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29,770 |
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23,387 |
Loss from operations |
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(29,770) |
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(23,387) |
Grant income |
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157 |
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2,234 |
Other income, net |
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1,793 |
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173 |
Net loss |
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$ (27,820) |
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$ (20,980) |
Unrealized gain (loss) on available-for-sale securities |
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927 |
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(1,068) |
Comprehensive loss attributable to common stockholders |
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$ (26,893) |
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$ (22,048) |
Net loss per share attributable to common stockholders, |
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$ (0.73) |
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$ (0.56) |
Weighted-average shares used in computing net loss per |
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37,923,402 |
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37,593,328 |