Form 8-K - Current report

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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 12, 2024

Artiva Biotherapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware		001-42179		83-3614316
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

5505 Morehouse Drive, Suite 100

San Diego, California 92121

(Address of principal executive offices)

Registrant’s telephone number, including area code: [phone]

N/A

(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:

 

 

☐	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		ARTV		Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in 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. ☐

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Item 2.02	Results of Operations and Financial Condition.

On November 12, 2024, Artiva Biotherapeutics, Inc. (“Artiva”) issued a press release announcing its financial results for the quarter ended September 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1.

The information contained under this Item 2.02, including Exhibit 99.1 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 otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, regardless of any general incorporation language in any such filing, unless Artiva expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.

Item 9.01	Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release, dated November 12, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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.

Artiva Biotherapeutics, Inc.
By:		/s/ Fred Aslan
		Fred Aslan, M.D.
		President and Chief Executive Officer

Dated: November 12, 2024

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Exhibit 99.1

Artiva Biotherapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights

•

Expanded Board of Directors with appointment of Dr. Alison Moore bringing cell therapy and manufacturing expertise to advance AlloNK® in autoimmune diseases

•

Initial data for AlloNK® in autoimmune indications expected H1 2025

•

Robust balance sheet with cash, cash equivalents and investments of $199.6 million as of September 30, 2024, is expected to fund operations at least through end of 2026

SAN DIEGO, November 12, 2024 -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, today announced financial results for the third quarter ended September 30, 2024, and highlighted recent progress.

“As AlloNK® advances in the clinic, we were pleased to expand our Board of Directors with the appointment of Dr. Alison Moore, an experienced executive in manufacturing and technical operations in allogenic cell therapies,” said Fred Aslan, M.D., CEO of Artiva. “We remain focused on generating clinical data and strengthening Artiva’s talent in autoimmune disease and cell therapy across the organization as we prepare for this next stage of growth.”

Recent Business Highlights

Corporate and Financial Updates

•

Expanded Board of Directors: In October 2024, Artiva appointed Alison Moore, Ph.D., as an independent member of its Board of Directors. Dr. Moore brings over 25 years of executive experience in the biotechnology and pharmaceutical industry, including an extensive background in cell therapy manufacturing. She currently serves as Chief Technical Officer (CTO) of Codexis Inc., a leading enzyme engineering company, and was the former CTO of Allogene Therapeutics, a pioneering clinical-stage company advancing CAR T-cell therapies.

•

Completed upsized $179.0 Million initial public offering: In July 2024, Artiva sold 14,920,000 shares of its common stock, including partial exercise of the overallotment option, at a public offering price of $12.00 per share, for gross proceeds of $179.0 million.

AlloNK® Clinical Updates

•

In August 2024, Artiva announced the treatment of its first patient was initiated in an investigator-initiated basket trial (IIT) assessing the safety, tolerability, and clinical activity of AlloNK® (AB-101) in combination with rituximab in patients with rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis/microscopic polyangiitis, and systemic lupus erythematosus (SLE). The trial is being conducted by Integral Rheumatology & Immunology Specialists, a community rheumatology clinic, demonstrating the potential to bring AlloNK® to patients in a community setting in addition to academic and transplant centers.

•

AlloNK® is also in clinical evaluation in combination with rituximab or obinutuzumab in an Artiva sponsored Phase 1/1b trial for treatment of SLE, for patients with or without lupus nephritis.

•

Initial data for AlloNK® in autoimmune indications from the Phase 1/1b trial or the basket IIT expected in the first half of 2025.

Third Quarter 2024 Financial Results

•

Cash, Cash Equivalents and Investments. As of September 30, 2024, Artiva had cash, cash equivalents, and investments of $199.6 million. This includes $179.0 million in gross proceeds from Artiva’s completed initial public offering in July 2024 in which it sold 14,920,000 shares of its common stock, including partial exercise of the overallotment option. Existing cash, cash equivalents, and investments as of September 30, 2024, are expected to fund operations at least through the end of 2026 and through key clinical data milestones.

•

Collaboration Revenue. Collaboration revenue was $0 for the three months ended September 30, 2024, compared to $26.7 million for the three months ended September 30, 2023. Revenues in 2023 were related to the Merck Sharpe & Dohme Corp. collaboration which was terminated in October 2023.

•

Research and Development Expenses. Research and development expenses were $13.5 million for the three months ended September 30, 2024, compared to $13.1 million for the three months ended September 30, 2023.

 

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•

General and Administrative Expenses. General and administrative expenses were $4.8 million for the three months ended September 30, 2024, compared to $2.8 million for the three months ended September 30, 2023.

•

Other Income (Expense), net. Other income (expense), net, was $0.9 million for the three months ended September 30, 2024, compared to other income (expense), net, of $0.5 million for the three months ended September 30, 2023.

•

Net Income (Loss). Net loss totaled $17.5 million for the three months ending September 30, 2024, as compared to net income of $11.3 million for the three months ending September 30, 2023, with non-cash stock-based compensation expense of $1.9 million and $1.4 million for the three months ended September 30, 2024 and 2023, respectively.

About Artiva Biotherapeutics

Artiva is a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK® is currently in clinical trials for treatment of systemic lupus erythematosus, for patients with or without lupus nephritis, and in an investigator-initiated basket trial in multiple autoimmune indications. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs.

Artiva is headquartered in San Diego, California. For more information, please visit www.artivabio.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Artiva Biotherapeutics, Inc. (the “Company”) regarding the potential benefits, accessibility, effectiveness and safety of AlloNK®; the Company’s ability to advance AlloNK® in autoimmune disease; the Company’s expectations regarding timing and availability of data from the Phase 1/1b trial or the IIT; and the Company’s future results of operations and financial position, including cash runway. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

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Artiva Biotherapeutics, Inc.

Condensed Balance Sheets

(unaudited)

(in thousands)

 

		September 30, 2024				December 31, 2023
Assets
Cash, cash equivalents and investments		$	199,597			$	76,971
Property and equipment, net			6,857				8,096
Operating and financing lease right-of-use assets			14,652				16,547
Other assets			4,490				3,500
Total assets		$	225,596			$	105,114
Liabilities, convertible preferred stock, and stockholders' equity (deficit)
Accounts payable and accrued expenses		$	9,559			$	8,631
Operating and financing lease liabilities			14,968				16,912
Simple agreements for future equity (SAFEs)			—				25,100
Other liabilities			73				73
Total liabilities			24,600				50,716
Convertible preferred stock			—				216,413
Stockholders' equity (deficit)			200,996				(162,015	)
Total liabilities, convertible preferred stock, and stockholders' equity (deficit)		$	225,596			$	105,114

 

 

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Artiva Biotherapeutics, Inc.

Condensed Statements of Operation and Comprehensive Income (Loss)

(unaudited)

(in thousands, except share and per share data)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
Revenue
Collaboration revenue		$	—			$	26,656			$	—			$	31,142
License and development support revenue			—				—				251				—
Total revenue			—				26,656				251				31,142
Operating expenses:
Research and development			13,524				13,065				37,011				39,098
General and administrative			4,811				2,780				12,255				10,745
Total operating expenses			18,335				15,845				49,266				49,843
Income (loss) from operations			(18,335	)			10,811				(49,015	)			(18,701	)
Other income (expense)
Interest income			1,846				418				3,172				1,952
Change in fair value of SAFEs			(977	)			—				(3,597	)			—
Other income (expense), net			(6	)			50				162				27
Total other income (expense)			863				468				(263	)			1,979
Net income (loss)		$	(17,472	)		$	11,279			$	(49,278	)		$	(16,722	)
Net income (loss) per share, basic		$	(0.92	)		$	13.98			$	(7.16	)		$	(20.89	)
Net income (loss) per share, diluted		$	(0.92	)		$	1.62			$	(7.16	)		$	(20.89	)
Weighted-average common shares outstanding, basic			18,896,829				806,714				6,883,271				800,541
Weighted-average common shares outstanding, diluted			18,896,829				6,967,099				6,883,271				800,541
Comprehensive income (loss):
Net income (loss)		$	(17,472	)		$	11,279			$	(49,278	)		$	(16,722	)
Other comprehensive income			217				144				30				271
Comprehensive income (loss)		$	(17,255	)		$	11,423			$	(49,248	)		$	(16,451	)

 

Contacts

Investors: Neha Krishnamohan, Artiva Biotherapeutics, [e-mail]

Media: Jessica Yingling, Ph.D., Little Dog Communications Inc., [e-mail], +1.858.344.8091

Source: Artiva Biotherapeutics, Inc.

 

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Document and Entity Information	Nov. 12, 2024
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001817241
Document Type	8-K
Document Period End Date	Nov. 12, 2024
Entity Registrant Name	Artiva Biotherapeutics, Inc.
Entity Incorporation State Country Code	DE
Entity File Number	001-42179
Entity Tax Identification Number	83-3614316
Entity Address, Address Line One	5505 Morehouse Drive
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92121
City Area Code	(858)
Local Phone Number	267-4467
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, $0.0001 par value per share
Trading Symbol	ARTV
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	false

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