Artiva Biotherapeutics, Inc.

Previous wording

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Our product candidates are derived from donor cells (allogeneic) rather than a patient’s own cells (autologous) and are pre-manufactured, stored frozen and ready to ship to a patient’s treatment location, making them what we believe to be “off-the-shelf.” Our lead product candidate, AlloNK, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs) in an ongoing (i) Phase 1/1b trial in systemic lupus erythematosus (SLE) with or without lupus nephritis (LN), (ii) Phase 2a basket trial in multiple autoimmune indications, and (iii) basket investigator-initiated trial (IIT) in multiple autoimmune indications.

Current wording

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Our product candidates are derived from donor cells (allogeneic) rather than a patient’s own cells (autologous) and are pre-manufactured, stored frozen and ready to ship to a patient’s treatment location, making them what we believe to be “off-the-shelf.” Our lead product candidate, AlloNK, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs) in an ongoing Phase 1/1b trial in systemic lupus erythematosus (SLE) with or without lupus nephritis (LN), Phase 2a basket trial in multiple autoimmune indications, and basket investigator-initiated trial (IIT) in multiple autoimmune indications.

Previous wording

In May 2025, we announced our initiation in late 2024 of patient treatment with AlloNK in combination with mAbs in the Phase 1/1b trial in SLE / LN, and prioritization of patient enrollment for AlloNK in combination with obinutuzumab. In addition, we announced that, following Investigational New Drug application clearance by the U.S. Food and Drug Administration, we are initiating a global Phase 2a company-sponsored basket clinical trial for AlloNK in combination with rituximab for refractory rheumatoid arthritis (RA), Sjögren’s disease, idiopathic inflammatory myopathies and systemic sclerosis, with site initiation underway, which we believe is the first company-sponsored trial exploring an allogeneic cell therapy in refractory RA and Sjögren’s disease in the U.S. The protocol for the Phase 2a basket trial allows for continuous enrollment with no stagger within dose levels and no hospitalization or inpatient requirement for patients dosed with AlloNK, and we are currently exploring 1 billion cells per AlloNK dose in company-sponsored trials with plan to escalate to 4 billion cells per AlloNK dose, across both company-sponsored trials. Seminal peer-reviewed clinical studies using autologous CD19 chimeric antigen receptor (CAR) T-cell therapy (auto-CAR-T) for the treatment of autoimmune diseases have demonstrated that deep B-cell depletion in the periphery and in the lymphoid tissue can lead to drug free disease remission. We have already demonstrated that AlloNK in combination with rituximab was able to drive deep B-cell depletion in the periphery and observed complete responses (CRs) in heavily pre-treated patients naïve to auto-CAR-T in our ongoing Phase 1/2 clinical trial in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). We believe the preliminary results from our Phase 1/2 clinical trial evaluating AlloNK in combination with rituximab in patients with B-NHL provide for a readthrough to autoimmune disease because efficacy in both diseases appears to be accomplished with a shared mechanism of action involving B-cell depletion in the periphery and in the lymphoid tissues, followed by an immunological reset and B-cell reconstitution. We expect to report initial safety and translational data for AlloNK in combination with a mAb across multiple autoimmune indications from ongoing clinical trials, and disclosure of our lead autoimmune indication for further development, by the end of 2025, and to report initial clinical response data in the lead autoimmune indication from ongoing clinical trials with longer follow-up to inform registrational strategy in the first half of 2026.

Current wording

Seminal peer-reviewed clinical studies using autologous CD19 chimeric antigen receptor (CAR) T-cell therapy (auto-CAR-T) for the treatment of autoimmune diseases have demonstrated that deep B-cell depletion in the periphery and in the lymphoid tissue can lead to drug free disease remission. We have already demonstrated that AlloNK in combination with rituximab was able to drive deep B-cell depletion in the periphery and observed complete responses (CRs) in heavily pre-treated patients naïve to auto-CAR-T in our Phase 1/2 clinical trial in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). We believe the preliminary results from our Phase 1/2 clinical trial evaluating AlloNK in combination with rituximab in patients with B-NHL provide for a readthrough to autoimmune disease because efficacy in both diseases appears to be accomplished with a shared mechanism of action involving B-cell depletion in the periphery and in the lymphoid tissues, followed by an immunological reset and B-cell reconstitution. In July 2025, we completed this trial and decided to discontinue the remaining long term follow up period to focus our resources on pursuing autoimmune indications. We expect to report initial safety and translational data for AlloNK in combination with a mAb across multiple autoimmune indications from ongoing clinical trials, and disclosure of our lead autoimmune indication for further development, by the end of 2025, and to report initial clinical response data in the lead autoimmune indication from ongoing clinical trials with longer follow-up to inform registrational strategy in the first half of 2026.

Previous wording

We have incurred a net loss of $20.3 million and $14.0 million during the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $267.0 million, cash, cash equivalents and investments of $166.0 million. We expect to continue to incur significant losses for the foreseeable future as we advance our current and future product candidates through preclinical and clinical development, continue to build our operations and transition to operating as a public company. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through public or private equity or debt financings or other capital sources, which may include our existing and any future strategic collaborations and other strategic arrangements with third parties. However, we may not be able to raise additional funds or enter into such other arrangements when needed or on favorable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration or licensing arrangements with third parties or other strategic transactions, we may have to relinquish rights to our intellectual property, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional capital or enter into such arrangements when needed, we could be forced to delay, limit, reduce or terminate our research and development programs or future commercialization efforts, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

Current wording

We have incurred a net loss of $41.6 million and $31.8 million during the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $288.2 million, cash, cash equivalents and investments of $142.4 million. We expect to continue to incur significant losses for the foreseeable future as we advance our current and future product candidates through preclinical and clinical development, continue to build our operations and transition to operating as a public company. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through public or private equity or debt financings or other capital sources, which may include our existing and any future strategic collaborations and other strategic arrangements with third parties. However, we may not be able to raise additional funds or enter into such other arrangements when needed or on favorable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration or licensing arrangements with third parties or other strategic transactions, we may have to relinquish rights to our intellectual property, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional capital or enter into such arrangements when needed, we could be forced to delay, limit, reduce or terminate our research and development programs or future commercialization efforts, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

Previous wording

License and development support-related revenues related to GC Cell’s development support activities under the AB-201 Agreement were zero and $0.3 million during the three months ended March 31, 2025 and 2024, respectively.

Current wording

License and development support-related revenues related to GC Cell’s development support activities under the AB-201 Agreement were zero during the three months ended June 30, 2025 and 2024, and zero and $0.3 million during the six months ended June 30, 2025 and 2024, respectively.

Previous wording

General and Administrative Expenses. General and administrative expenses were $5.1 million for the three months ended March 31, 2025, compared to $3.6 million for the three months ended March 31, 2024. The increase of $1.5 million was primarily comprised of a $1.2 million increase in personnel-related costs, including a $0.7 million increase in administrative personnel expenses and a $0.5 increase in non-cash stock-based compensation, in addition to a $0.3 million increase in other operational and legal costs.

Current wording

General and Administrative Expenses. General and administrative expenses were $4.9 million for the three months ended June 30, 2025, compared to $3.9 million for the three months ended June 30, 2024. The increase of $1.1 million was primarily comprised of a $1.0 million increase in personnel-related costs due to increased headcount, including a $0.9 million increase in administrative personnel expenses and a $0.1 million increase in non-cash stock-based compensation, in addition to a $0.1 million increase in other operational and legal costs.

Previous wording

License and Development Support Revenue. License and development support revenues were zero for the three months ended March 31, 2025, compared to $0.3 million for the three months ended March 31, 2024. Revenues were related to development support activities under the AB-201 Agreement with GC Cell.

Current wording

License and Development Support Revenue. License and development support revenues were zero for the six months ended June 30, 2025, compared to $0.3 million for the six months ended June 30, 2024. Revenues were related to development support activities under the AB-201 Agreement.

Previous wording

Research and development expenses were $17.1 million for the three months ended March 31, 2025, compared to $11.2 million for the three months ended March 31, 2024. The increase of $5.9 million was primarily due to a $4.2 million increase in external research and development expense, and a $1.7 million increase in internal research and development expense. The $4.2 million increase in external research and development expense is primarily due to a $4.2 million increase in AB-101 costs related to product candidate development and clinical trials as we progressed towards the end of our Phase 1/2 clinical trial for the B-NHL program and commencement of our clinical trial on the AlloNK for SLE/LN program. The $1.7 million increase in internal research and development expense is primarily due to a $1.5 million increase in personnel-related expenses due to increased headcount, inclusive of an increase of $0.2 million of non-cash stock-based compensation expense, in addition to a $0.2 million increase in other operating costs.

Current wording

Research and development expenses were $34.9 million for the six months ended June 30, 2025, compared to $23.5 million for the six months ended June 30, 2024. The increase of $11.4 million was primarily due to a $8.4 million increase in external research and development expense, and a $3.0 million increase in internal research and development expense. The $8.4 million increase in external research and development expense is due to an increase in AlloNK costs related to product candidate development and ongoing clinical trials exploring AlloNK in autoimmune diseases. The $3.0 million increase in internal research and development expense is primarily due to a $3.2 million increase in personnel-related expenses due to increased headcount, inclusive of an increase of $0.1 million of non-cash stock-based compensation expense, partially offset by a $0.2 million decrease in other operating costs.

Previous wording

Other Income, Net. Other income was $1.9 million for the three months ended March 31, 2025, compared to other income of $0.5 million for the three months ended March 31, 2024. The increase of $1.3 million was primarily due to a $1.2 million increase in dividend and interest income due to higher investment balances in 2025. Additionally there was a $0.3 million change in fair value of SAFEs in 2024 that did not occur in 2025, contributing to a $0.3 million increase. These increases were partially offset by a $0.2 million decrease in other income.

Current wording

Other Income (Expense), Net. Other income was $3.4 million for the six months ended June 30, 2025, compared to other expense of $1.1 million for the six months ended June 30, 2024. The increase of $4.5 million was primarily due to a $2.1 million increase in interest income due to higher investment balances in 2025. Additionally there was a $2.6 million change in fair value of SAFEs in 2024 that did not occur in 2025. These increases were partially offset by a $0.2 million decrease in other income.

Previous wording

Unrealized Gain (Loss) on Investments. Unrealized gain on investments was $0.1 million for the three months ended March 31, 2025, compared to an unrealized loss of $0.1 million for the three months ended March 31, 2024. The increase between periods of $0.2 million was primarily due to the change in fair value of investments.

Current wording

Unrealized Gain (Loss) on Investments. Unrealized gain on investments was $0.1 million for the six months ended June 30, 2025, compared to an unrealized loss of $0.2 million for the six months ended June 30, 2024. The increase between periods of $0.3 million was primarily due to the change in fair value of investments.

Previous wording

We have incurred net losses and negative cash flows from operations since our inception and expect to continue to incur significant and increasing operating losses for the foreseeable future. We have never generated any revenue from product sales and do not expect to generate any revenues from product sales unless and until we successfully complete development of and obtain regulatory approval for our product candidates, which will not be for several years, if ever. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. From our inception through March 31, 2025, we have raised aggregate gross proceeds of $401.7 million to fund our operations, comprised primarily from proceeds received from the IPO, including proceeds from the underwriters’ partial exercise of their overallotment option, our issuance of convertible promissory notes, SAFEs and private placements of our convertible preferred stock. In February 2021, we received a $30.0 million up-front payment from Merck for our two target programs. In addition, as of March 31, 2025, we have received $9.9 million related to reimbursable research services from Merck. As of March 31, 2025, we had cash, cash equivalents and investments of $166.0 million, and an accumulated deficit of $267.0 million. Based on our current operating plans, we expect our existing cash, cash equivalents and investments will be sufficient to fund our planned operating expenses and capital expenditure requirements into the second quarter of 2027. Our total future capital requirements will depend on many factors and is subject to the risks and uncertainties set forth in the section titled “Risk Factors.”

Current wording

We have incurred net losses and negative cash flows from operations since our inception and expect to continue to incur significant and increasing operating losses for the foreseeable future. We have never generated any revenue from product sales and do not expect to generate any revenues from product sales unless and until we successfully complete development of and obtain regulatory approval for our product candidates, which will not be for several years, if ever. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. From our inception through June 30, 2025, we have raised aggregate gross proceeds of $401.7 million to fund our operations, comprised primarily from proceeds received from the IPO, including proceeds from the underwriters’ partial exercise of their overallotment option, our issuance of convertible promissory notes, SAFEs and private placements of our convertible preferred stock. In February 2021, we received a $30.0 million up-front payment from Merck for our two target programs. In addition, as of June 30, 2025, we have received $9.9 million related to reimbursable research services from Merck. As of June 30, 2025, we had cash, cash equivalents and investments of $142.4 million, and an accumulated deficit of $288.2 million. Based on our current operating plans, we expect our existing cash, cash equivalents and investments will be sufficient to fund our planned operating expenses and capital expenditure requirements into the second quarter of 2027. Our total future capital requirements will depend on many factors and is subject to the risks and uncertainties set forth in the section titled “Risk Factors.”

Previous wording

the impact of geopolitical and macroeconomic events, including tariffs, future bank failures, increased geopolitical tensions between the United States and China, the Russia/Ukraine conflict, the Israel-Hamas war and global pandemics on United States and global economic conditions including changes in monetary and fiscal policy, United States political developments and other sources of instability that may impact our ability to access capital on acceptable terms, if at all.

Current wording

the impact of geopolitical and macroeconomic events, including tariffs, future bank failures, increased geopolitical tensions between the United States and China, the Russia/Ukraine conflict, the conflicts in the Middle East and global pandemics on United States and global economic conditions including changes in monetary and fiscal policy, United States political developments and other sources of instability that may impact our ability to access capital on acceptable terms, if at all.

Previous wording

The following table sets forth a summary of the net cash flow activity for the three months ended March 31, 2025, and 2024 (in thousands):

Current wording

The following table sets forth a summary of the net cash flow activity for the six months ended June 30, 2025, and 2024 (in thousands):

Previous wording

Net cash used in operating activities for the three months ended March 31, 2025, was $19.8 million, consisting primarily of our net loss incurred during the period of $20.3 million, partially offset by $2.0 million of non-cash charges. Non-cash charges consisted of $2.1 million in stock-based compensation expense, $0.7 million of accretion of discounts on investments, and $0.6 million in depreciation and amortization expense. Changes in operating assets and liabilities included a $0.9 million decrease in accrued expenses, a $0.8 million increase in prepaid expense and other current assets, and a $0.2 million change in other net balance sheet assets and liabilities

Current wording

Net cash used in operating activities for the six months ended June 30, 2025, was $42.8 million, consisting primarily of our net loss incurred during the period of $41.6 million and net changes in operating assets and liabilities of $4.9 million, partially offset by $3.6 million of net non-cash charges. Net non-cash charges consisted of $3.6 million in stock-based compensation expense, $1.2 million in depreciation and amortization expense, partially offset by $1.2 million in accretion of discounts on investments. Changes in operating assets and liabilities included a $3.6 million increase in prepaid expense and other current assets, a $1.5 million decrease in accrued expenses, and a $0.2 million change in other net balance sheet assets and liabilities.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2024, was $15.1 million, consisting primarily of our net loss incurred during the period of $14.0 million and $3.0 million of a net decrease in operating assets and liabilities, partially offset by $1.9 million of net non-cash charges. Non-cash charges consisted primarily of $1.4 million in stock-based compensation expense, $0.6 million in depreciation and amortization expense and $0.3 million in change in fair value of SAFEs, offset by $0.4 million of accretion of discounts on investments. The net change in operating assets and liabilities primarily related to a $3.0 million decrease in accrued expenses and a $1.0 million decrease in prepaid expense and other current assets, offset by a $0.9 million decrease in accounts payable and a $0.1 million decrease in other net balance sheet liabilities.

Current wording

Net cash used in operating activities for the six months ended June 30, 2024, was $28.8 million, consisting primarily of our net loss incurred during the period of $31.8 million and $3.1 million of a net decrease in operating assets and liabilities, partially offset by $6.1 million of non-cash charges. Non-cash charges consisted of $2.9 million in stock-based compensation expense, $1.2 million in depreciation and amortization expense and a $2.6 million in change in fair value of SAFEs, offset by $0.6 million of accretion of discounts on investments. The net change in operating assets and liabilities primarily related to a $2.8 million decrease in accrued expenses, a $0.3 million decrease in receivables, a $0.1 million decrease in other net balance sheet liabilities and a $0.1 million decrease in accounts payable, offset by a $0.6 million increase in prepaid expense and other current assets.

Previous wording

Net cash provided by investing activities for the three months ended March 31, 2025, was $10.0 million related to $29.0 million in maturities of investments, partially offset by $18.5 million in purchases of investments and $0.5 million in purchases of property and equipment.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2025, was $31.1 million related to $57.3 million in maturities of investments, partially offset by $24.6 million in purchases of investments and $1.6 million in purchases of property and equipment.

Previous wording

Net cash provided by investing activities for the three months ended March 31, 2024, was $9.8 million related to $16.0 million in maturities of investments, partially offset by $6.2 million of purchases of investments.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2024, was $11.1 million related to $30.0 million in maturities of investments, partially offset by $18.4 million of purchases of investments and $0.5 million of purchases of property and equipment.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2025, was $0.2 million primarily related to cash received from stock option exercises and stock issued in association with our 2024 Employee Stock Purchase Plan (ESPP).

Current wording

Net cash provided by financing activities for the six months ended June 30, 2025, was $0.2 million primarily related to cash received from stock option exercises and stock issued in association with our 2024 Employee Stock Purchase Plan (ESPP).

Previous wording

On July 22, 2022, we entered into a sublease (the Sublease Agreement) with Origis Operating Services, LLC, (the Sublessee), whereby we agreed to sublease to Sublessee all of the 13,405 rentable square feet of office space currently leased by us under the Executive Drive Lease. The sublease commenced on August 1, 2022, and has a term through December 31, 2025. The aggregate base rent is approximately $2.6 million commencing August 1, 2022. We record sublease income as a reduction of general and administrative expense. Upon execution of the Sublease Agreement, we received a cash security deposit of $0.1 million from the Sublessee which is recorded as other non-current liabilities in the balance sheets.

Current wording

On July 22, 2022, we entered into a sublease (the Sublease Agreement) with Origis Operating Services, LLC, (the Sublessee), whereby we agreed to sublease to Sublessee all of the 13,405 rentable square feet of office space currently leased by us under the Executive Drive Lease. The sublease commenced on August 1, 2022, and has a term through December 31, 2025. The aggregate base rent is approximately $2.6 million commencing August 1, 2022. We record sublease income as a reduction of general and administrative expense. Upon execution of the Sublease Agreement, we received a cash security deposit of $0.1 million from the Sublessee which is recorded as other current liabilities in the condensed balance sheet as of June 30, 2025 and other non-current liabilities in the balance sheet as of December 31, 2024.

Previous wording

As of March 31, 2025, we have future remaining operating lease payments of $16.5 million relating to leases we have recognized in the condensed balance sheets, of which $3.1 million is payable before December 31, 2025.

Current wording

As of June 30, 2025, we have future remaining operating lease payments of $15.5 million relating to leases we have recognized in the condensed balance sheets, of which $2.1 million is payable before December 31, 2025.

Previous wording

We are an emerging growth company under the Jumpstart Our Business Startups Act (JOBS Act). Under the JOBS Act, we can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period for complying with new or revised accounting standards and as a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates. However, we may elect to early adopt any new or revised accounting standards whenever such early adoption is permitted for non-public companies. We may take advantage of these exemptions up until the time that we are no longer an emerging growth company.

Current wording

We are an emerging growth company under the Jumpstart Our Business Startups Act (JOBS Act). Under the JOBS Act, we can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period for complying with new or revised accounting standards and as a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates.

Previous wording

We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year following the fifth anniversary of our IPO, (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion, (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange

Current wording

We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year following the fifth anniversary of our IPO, (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion, (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year, or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.