ATHA Athira Pharma Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 7, 2024

 

Athira Pharma, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware	001-39503	45-3368487
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

 

18706 North Creek Parkway, Suite 104
Bothell, WA 98011

(Address of principal executive offices, including zip code)

 

(425) 620-8501

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

 

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):

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	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:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0001 par value per share	ATHA	The Nasdaq Stock Market LLC  (The Nasdaq Global Select Market)

 

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).

Emerging Growth Company	☒

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 7, 2024, Athira Pharma, Inc. (the “Company”) issued a press release reporting its financial results for the quarter ended September 30, 2024. 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.		Description
99.1		Athira Pharma, Inc. press release dated November 7, 2024
104		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.

 

			Athira Pharma, Inc.
Date:	November 7, 2024	By:	/s/ Mark Litton
			Mark Litton
			President and Chief Executive Officer

 

 

---

 

Athira Pharma Reports Third Quarter 2024 Financial Results and Pipeline and Business Updates

 

Expects to complete healthy volunteer Phase 1 clinical study of ATH-1105 by year end and begin dosing ALS patients in 2025

 

BOTHELL, Wash., November 7, 2024 – Athira Pharma, Inc. (NASDAQ: ATHA), a 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, 2024, and provided recent pipeline and business updates.

 

“We are pleased to be continuing the advancement of ATH-1105 as a potential treatment for ALS. This novel, oral, next-generation HGF-modulating drug candidate has improved blood-brain-barrier penetration and pharmacokinetic properties. Specifically, preclinically ATH-1105 has shown a consistent ability in various ALS models to reduce plasma neurofilament light chain (NfL) levels, a key marker of ALS disease progression, and to improve motor and nerve function, enhance neuronal survival, and improve biomarkers of inflammation and neurodegeneration,“ said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “We continue to progress ATH-1105 in the ongoing Phase 1 study in healthy volunteers, which is targeted to complete by year end, and look forward to dosing ALS patients in 2025.”

 

Clinical Development & Pipeline Programs

 

Athira’s drug development pipeline includes potential first-in-class and next-generation novel small molecule drug candidates designed to promote the neurotrophic hepatocyte growth factor (HGF) system, which activates neuroprotective, neurotrophic and anti-inflammatory pathways in the central nervous system. Athira’s drug candidates have distinct properties which the Company believes may be applicable to a broad range of neurodegenerative diseases.

 

ATH-1105 – A next-generation, novel, orally administered, small molecule drug candidate in development for the potential treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.

 

---

 

Fosgonimeton (ATH-1017) – A once daily, subcutaneously administered drug candidate initially targeted for the potential treatment of Alzheimer’s disease.

 

Plans to Explore Strategic Alternatives

 

Financial Results

 

About Athira Pharma, Inc.
Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a 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 drug 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: Athira’s drug candidates as potential treatments for amyotrophic lateral sclerosis, Alzheimer’s disease, and other neurodegenerative diseases; future development plans; the anticipated reporting of data; the potential learnings from preclinical studies and other nonclinical data and their ability to inform and improve future clinical development plans; expectations regarding the potential efficacy and commercial potential of Athira’s drug candidates; Athira’s ability to advance its drug candidates into later stages of development; and Athira’s plans and expectations regarding Athira’s exploration of strategic alternatives. 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,” “target,” 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 drug candidates; development of drug candidates may cease or be delayed; regulatory authorities could object to protocols, amendments and other submissions; future potential regulatory milestones for drug candidates, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; whether Athira’s trials are sufficiently powered to meet the planned endpoints; 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 drug candidates with other treatments; Athira’s assumptions regarding its financial condition and 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; the impact of expanded drug candidate development and clinical activities on operating expenses; the impact of new or changing laws and regulations; risks related to Athira’s exploration of strategic alternatives; 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

Julie.rathbun@athira.com

206-769-9219

 

 

---

Athira Pharma, Inc.

Condensed Consolidated Balance Sheets

(Amounts in thousands)

 

		September 30,				December 31,
		2024				2023
		(unaudited)
Assets
Cash and cash equivalents		$	68,856			$	90,584
Short-term investments			—				56,835
Other short-term assets			13,146				7,310
Other long-term assets			4,244				5,516
Total assets		$	86,264			$	160,245
Liabilities and stockholders' equity
Current liabilities		$	27,751			$	28,840
Long-term liabilities			912				1,217
Total liabilities			28,663				30,057
Stockholders' equity			57,583				130,188
Total liabilities and stockholders' equity		$	86,246			$	160,245

 

 

---

Athira Pharma, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Amounts in thousands, except share and per share amounts)

(Unaudited)

 

		Three Months Ended September 30,
		2024		2023
Operating expenses:
Research and development		$ 17,922		$ 27,202
General and administrative		7,572		7,840
Legal expense		4,127		—
Total operating expenses		29,621		35,042
Loss from operations		(29,621)		(35,042)
Other income, net		880		2,072
Net loss		$ (28,741)		$ (32,970)
Unrealized gain on available-for-sale securities		41		261
Comprehensive loss attributable to common stockholders		$ (28,700)		$ (32,709)
Net loss per share attributable to common stockholders,    basic and diluted		$ (0.75)		$ (0.87)
Weighted-average shares used in computing net loss per    share attributable to common stockholders, basic    and diluted		38,517,602		38,054,583

 

 

---

v3.24.3

Document and Entity Information	Nov. 07, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 07, 2024
Entity Registrant Name	Athira Pharma, Inc.
Entity Central Index Key	0001620463
Entity Incorporation, State or Country Code	DE
Securities Act File Number	001-39503
Entity Tax Identification Number	45-3368487
Entity Address, Address Line One	18706 North Creek Parkway
Entity Address, Address Line Two	Suite 104
Entity Address, City or Town	Bothell
Entity Address, State or Province	WA
Entity Address, Postal Zip Code	98011
City Area Code	425
Local Phone Number	620-8501
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	ATHA
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	false

---