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

Rhea-AI Summary

Artiva Biotherapeutics (Nasdaq: ARTV) reported Q2 2024 financial results and recent business highlights. Key points include:

• Successful completion of a $179.0 million upsized IPO, extending cash runway through 2026
• Initiation of an investigator-initiated basket trial exploring AlloNK® in multiple autoimmune indications
• Treatment of the first patient in a Phase 1/1b trial for lupus nephritis (LN) and systemic lupus erythematosus (SLE)
• Q2 2024 financial results: $46.6 million in cash and investments (pre-IPO), $12.3 million in R&D expenses, and a net loss of $17.8 million

Artiva aims to report initial data on autoimmune indications from ongoing trials in the first half of 2025.

Positive

• Successful completion of $179.0 million upsized IPO, extending cash runway through 2026
• Initiation of investigator-initiated basket trial for AlloNK® in multiple autoimmune indications
• Treatment of first patient in Phase 1/1b trial for lupus nephritis and systemic lupus erythematosus
• Expansion of Phase 1/1b trial to include SLE patients without kidney involvement

Negative

• Net loss increased to $17.8 million in Q2 2024 from $11.3 million in Q2 2023
• Collaboration revenue decreased from $3.5 million in Q2 2023 to $0 in Q2 2024
• Other expense of $1.7 million in Q2 2024 compared to other income of $0.5 million in Q2 2023

Insights

Financial Analyst

Artiva's Q2 2024 results reflect a company in transition, with both promising developments and financial challenges. The successful IPO raising $179 million significantly strengthens their balance sheet, extending the cash runway through 2026. This provides important financial stability for their clinical programs.

However, the net loss increased to $17.8 million, up from $11.3 million in Q2 2023. This widening loss is primarily due to the termination of the Merck collaboration, resulting in zero collaboration revenue compared to $3.5 million last year. R&D expenses also increased slightly, indicating continued investment in their pipeline.

The cash position of $46.6 million pre-IPO, combined with the IPO proceeds, puts Artiva in a strong financial position to advance their clinical trials. Investors should monitor burn rate and clinical progress as key indicators of the company's trajectory.

Medical Research Analyst

Artiva's progress with AlloNK® in autoimmune diseases is noteworthy. The initiation of two clinical trials - an investigator-initiated basket trial and a company-sponsored Phase 1/1b trial - marks significant milestones. The basket trial's diverse indications (rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis/microscopic polyangiitis and SLE) showcase the potential broad applicability of AlloNK®.

Particularly intriguing is the treatment of the first lupus nephritis patient with an allogeneic, off-the-shelf NK cell therapy in a U.S. clinical trial. This could represent a paradigm shift in autoimmune disease treatment if proven effective and safe. The expansion to include SLE patients without kidney involvement further broadens the potential patient population.

Investors should eagerly anticipate the initial data expected in H1 2025, which could provide important insights into AlloNK®'s efficacy and safety profile across multiple autoimmune indications.

• Strong balance sheet with successful completion of upsized $179.0 million initial public offering
• Treatment initiated in the first patient in an investigator-initiated basket trial of AlloNK® exploring multiple autoimmune indications
• Treated first patient in Artiva sponsored Phase 1/1b trial in patients with class III or IV lupus nephritis (LN) and expanded trial to include patients with systemic lupus erythematosus (SLE) without kidney involvement
  

SAN DIEGO, Aug. 29, 2024 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV), 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 second quarter ended June 30, 2024, and highlighted recent progress.

“Artiva is at an inflection point as we advance AlloNK® in clinical development across multiple autoimmune indications and transition to a publicly traded company,” said Fred Aslan, M.D., Artiva’s Chief Executive Officer. “With two trials in autoimmunity underway, we are focused on the potential of AlloNK® in delivering effective, safe, and accessible cell therapies for patients with devastating autoimmune disease.”

Recent Business Highlights

AlloNK®

• Treatment initiated in the first patient in an investigator-initiated basket trial (IIT) exploring AlloNK® in combination with rituximab in patients with rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis/microscopic polyangiitis, and SLE. The trial is being conducted by Integral Rheumatology & Immunology Specialists (IRIS), a community rheumatology clinic, demonstrating the potential to bring AlloNK® to patients in a community setting in addition to academic and transplant centers. The study is assessing the safety, tolerability, and clinical activity of AlloNK® (also known as AB-101).  
• Announced treatment of the first LN patient in Artiva sponsored Phase 1/1b trial in April 2024. To Artiva's knowledge, this marks the first patient to receive an allogeneic, off-the-shelf NK cell therapy in a U.S. clinical trial for treatment of an autoimmune disease. In the Phase 1/1b trial, AlloNK® will be administered in combination with rituximab or obinutuzumab. The trial was expanded to include patients with SLE without kidney involvement.
• Expect to report initial data on autoimmune indications from at least one of the Phase 1/1b trial or the basket IIT in the first half of 2025.
  

Corporate and Financial Updates

• Significantly extended cash runway through the completion of Artiva’s initial public offering (IPO). Strengthened balance sheet with approximately $179.0 million in gross proceeds from the IPO in July 2024, which extends cash runway at least through the end of 2026 and through key clinical data milestones.
  

Second Quarter 2024 Financial Results

• Cash, Cash Equivalents and Short-Term Investments. As of June 30, 2024, Artiva had cash, cash equivalents, and short-term investments of $46.6 million. In addition, Artiva completed its IPO in July 2024 in which it sold 14,920,000 shares of its common stock, including partial exercise of the overallotment option, for gross proceeds of $179.0 million.
• Collaboration Revenue. Collaboration revenue was $0 for the three months ended June 30, 2024, compared to $3.5 million for the three months ended June 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 $12.3 million for the three months ended June 30, 2024, compared to $11.3 million for the three months ended June 30, 2023.
• General and Administrative Expenses. General and administrative expenses were $3.9 million for the three months ended June 30, 2024, compared to $4.1 million for the three months ended June 30, 2023.
• Other Income (Expense), net. Other expense, net, was $1.7 million for the three months ended June 30, 2024, compared to other income, net, of $0.5 million for the three months ended June 30, 2023. Other expense, net, for the three months ended June 30, 2024, includes a loss on change in fair value of simple agreements for future equity (SAFEs) of $2.4 million.
• Net Loss. Net loss totaled $17.8 million for the three months ending June 30, 2024, as compared to $11.3 million for the three months ending June 30, 2023, with non-cash stock-based compensation expense of $1.5 million and $2.5 million for the three months ended June 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 https://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 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. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words.  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, including business, regulatory, economic and competitive risks and uncertainties about the Company, including, without limitation, risks inherent in developing product candidates, future results from the Company’s ongoing and planned clinical trials, risks related to conducting clinical trials, including delays in activation of clinical trial sites or in subject enrollment, the Company’s ability to obtain adequate financing to fund its planned clinical trials and other expenses, risks that future clinical trial results may not be consistent with interim, initial or preliminary results or results from prior preclinical studies or clinical trials, trends in the industry, the Company’s relationships with its existing and future collaboration partners, the legal and regulatory framework for the industry and future expenditures. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the variations may be material.  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 June 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.

Artiva Biotherapeutics, Inc. Condensed Balance Sheets (unaudited) (in thousands)
	June 30, 2024				December 31, 2023
Assets
Cash, cash equivalents and short-term investments	$	46,556			$	76,971
Property and equipment, net		7,315				8,096
Operating and financing lease right-of-use assets		15,420				16,547
Other assets		6,621				3,500
Total assets	$	75,912			$	105,114
Liabilities, convertible preferred stock, and stockholders' deficit
Accounts payable and accrued expenses	$	7,037			$	8,631
Operating and financing lease liabilities		15,765				16,912
Simple agreements for future equity (SAFEs)		27,720				25,100
Other liabilities		74				73
Total liabilities		50,596				50,716
Convertible preferred stock		216,413				216,413
Stockholders' deficit		(191,097	)			(162,015	)
Total liabilities, convertible preferred stock, and stockholders' deficit	$	75,912			$	105,114

Artiva Biotherapeutics, Inc. Condensed Statements of Operation and Comprehensive Loss (unaudited) (in thousands, except share and per share data)
	Three Months Ended June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
Revenue
Collaboration revenue	$	—			$	3,497			$	—			$	4,487
License and development support revenue		—				—				251				—
Total revenue		—				3,497				251				4,487
Operating expenses:
Research and development		12,333				11,262				23,488				26,033
General and administrative		3,857				4,059				7,444				7,965
Total operating expenses		16,190				15,321				30,932				33,998
Loss from operations		(16,190	)			(11,824	)			(30,681	)			(29,511	)
Other income (expense)
Interest income		676				509				1,326				1,533
Change in fair value of SAFEs		(2,352	)			—				(2,620	)			—
Other income (expense), net		23				31				169				(23	)
Total other income (expense)		(1,653	)			540				(1,125	)			1,510
Net loss	$	(17,843	)		$	(11,284	)		$	(31,806	)		$	(28,001	)
Net loss per share, basic and diluted	$	(22.00	)		$	(14.09	)		$	(39.24	)		$	(35.12	)
Weighted-average common shares outstanding, basic and diluted		811,210				800,889				810,484				797,403
Comprehensive loss:
Net Loss	$	(17,843	)		$	(11,284	)		$	(31,806	)		$	(28,001	)
Other comprehensive income (loss)		(86	)			127				(187	)			127
Comprehensive loss	$	(17,929	)		$	(11,157	)		$	(31,993	)		$	(27,874	)

Contacts
Investors: Neha Krishnamohan, Artiva Biotherapeutics, ir@artivabio.com
Media: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com, +1.858.344.8091

FAQ

What were Artiva Biotherapeutics' (ARTV) key financial results for Q2 2024?

Artiva reported $46.6 million in cash and investments (pre-IPO), $12.3 million in R&D expenses, and a net loss of $17.8 million for Q2 2024.

How much did Artiva Biotherapeutics (ARTV) raise in its IPO in July 2024?

Artiva raised approximately $179.0 million in gross proceeds from its upsized initial public offering in July 2024.

What clinical trials is Artiva Biotherapeutics (ARTV) currently conducting for AlloNK®?

Artiva is conducting an investigator-initiated basket trial exploring AlloNK® in multiple autoimmune indications and a Phase 1/1b trial for lupus nephritis and systemic lupus erythematosus.

When does Artiva Biotherapeutics (ARTV) expect to report initial data from its autoimmune trials?

Artiva expects to report initial data on autoimmune indications from at least one of its ongoing trials in the first half of 2025.