Kyverna Therapeutics Inc

Previous wording

We intend to initially focus our neurology development on myasthenia gravis, or MG; multiple sclerosis, or MS; and stiff person syndrome, or SPS. We received IND clearance in November 2023 for a Phase 2 trial in MG, IND clearance in December 2023 for a Phase 2 trial in MS, and IND clearance in June 2024 for a Phase 2 trial in SPS. We received U.S. Food and Drug Administration Orphan Drug Designation in April 2024 for KYV-101 for the treatment of MG. Furthermore, we received U.S. Food and Drug Administration Regenerative Medicine Advanced Therapy (RMAT) designation in July 2024 for KYV-101 for the treatment of SPS. We believe our approach may present a significant advantage over current standard-of-care therapies for autoimmune diseases by aiming to directly deplete B cells and potentially resetting disease-contributing B cells.

Current wording

We intend to initially focus our neurology development on myasthenia gravis, or MG; multiple sclerosis, or MS; and stiff person syndrome, or SPS. We received IND clearance in November 2023 for a Phase 2 trial in MG, IND clearance in December 2023 for a Phase 2 trial in MS, and IND clearance in June 2024 for a Phase 2 trial in SPS. We received U.S. Food and Drug Administration Orphan Drug Designation in April 2024 for KYV-101 for the treatment of MG. Furthermore, we received U.S. Food and Drug Administration Regenerative Medicine Advanced Therapy (RMAT) designation for KYV-101 for the treatment of SPS in July 2024, and for the treatment of MG in August 2024. We believe our approach may present a significant advantage over current standard-of-care therapies for autoimmune diseases by aiming to directly deplete B cells and potentially resetting disease-contributing B cells.

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. We have funded our operations primarily from sales of our redeemable convertible preferred stock, issuances of convertible notes, revenue from our collaboration agreement with Gilead Sciences, Inc., or Gilead, which terminated effective as of January 22, 2024, and from the sale of shares of our common stock in our initial public offering (the “IPO”) in February 2024. Our net losses were $28.8 million and $55.5 million for the three and six months ended June 30, 2024, respectively, compared with $13.1 million and $24.2 million net losses for the three and six months ended June 30, 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $191.5 million. Management has determined that our cash and cash equivalents and available-for-sale marketable securities of $346.2 million as of June 30, 2024 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. We plan to monitor expenses and raise additional capital through equity or debt financings, strategic alliances or licensing arrangements. Our ability to access capital when needed is not assured and if capital is not available to us when, and in the amounts, needed, we could be required to delay, scale back or abandon some or all of our development programs and other operations, which could materially harm our business, financial condition and results of operations.

Current wording

We have incurred significant losses and negative cash flows from operations since our inception. We have funded our operations primarily from sales of our redeemable convertible preferred stock, issuances of convertible notes, revenue from our collaboration agreement with Gilead Sciences, Inc., or Gilead, which terminated effective as of January 22, 2024, and from the sale of shares of our common stock in our initial public offering (the “IPO”) in February 2024. Our net losses were $34.5 million and $90.0 million for the three and nine months ended September 30, 2024, respectively, compared with $15.5 million and $39.7 million net losses for the three and nine months ended September 30, 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $226.0 million. Management has determined that our cash and cash equivalents and available-for-sale marketable securities of $321.6 million as of September 30, 2024 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. We plan to monitor expenses and raise additional capital through equity or debt financings, strategic alliances or licensing arrangements. Our ability to access capital when needed is not assured and if capital is not available to us when, and in the amounts, needed, we could be required to delay, scale back or abandon some or all of our development programs and other operations, which could materially harm our business, financial condition and results of operations.

Previous wording

We may be affected by worldwide economic conditions and challenges, such as the effects of the ongoing geopolitical conflicts in Ukraine, the Israel-Hamas war, tensions between Israel and Iran, tensions in United States-China relations, disruptions in the banking industry and inflationary trends. The fiscal years 2023 and 2022 were marked by significant market uncertainty and increasing inflationary pressures. These market dynamics continue into 2024, and these and similar adverse market conditions may negatively impact our business, financial position and results of operations. For further discussion of the potential impacts of macroeconomic events on us, refer to the section titled “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q.

Current wording

We may be affected by worldwide economic conditions and challenges, such as the effects of the ongoing geopolitical conflicts in Ukraine, the Israel-Hamas war, the conflict between Israel and Iran, tensions in United States-China relations, disruptions in the banking industry and inflationary trends. The fiscal years 2023 and 2022 were marked by significant market uncertainty and increasing inflationary pressures. These market dynamics continue into 2024, and these and similar adverse market conditions may negatively impact our business, financial position and results of operations. For further discussion of the potential impacts of macroeconomic events on us, refer to the section titled “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q.

Previous wording

Research and development expenses increased by $16.9 million, or 163%, from $10.4 million for the three months ended June 30, 2023 to $27.3 million for the three months ended June 30, 2024. License fees of $0.1 million and zero for the three months ended June 30, 2024 and 2023, respectively, mainly included expenses related to the minimum annual royalties payable under our in-licensing agreements. CRO, CMO and other third-party preclinical studies and clinical trial expenses increased by $12.7 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023, as we continued advancing our lead product candidate, KYV-101, through clinical development, and we continued to advance KYV-201 through preclinical development. Other research and development costs, including laboratory materials and supplies, decreased by $0.8 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023, mainly due to the timing of procurement of materials for our research and development activities.

Current wording

Research and development expenses increased by $15.5 million, or 114%, from $13.6 million for the three months ended September 30, 2023 to $29.2 million for the three months ended September 30, 2024. CRO, CMO and other third-party preclinical studies and clinical trial expenses increased by $10.6 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023, as we continued advancing our lead product candidate, KYV-101, through clinical development, and we continued to advance KYV-201 through preclinical development. Other research and development costs, including laboratory materials and supplies, decreased by $0.9 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023, mainly due to the procurement of materials for our research and development activities.

Previous wording

Personnel-related research and development costs increased by $3.8 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023 as a result of hiring personnel in our research and development organization. Our research and development headcount increased from 52 as of June 30, 2023 to 88 as of June 30, 2024. The increase in personnel-related research and development costs included an increase of $0.6 million in stock-based compensation expense. Facilities and overhead costs increased by $1.1 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023, mainly due to a $0.5 million increase in scientific conference costs, a $0.3 million increase in depreciation expense, a $0.2 million increase in software license expense, a $0.1 million increase in equipment repair costs and a $0.3 million increase in allocated overhead expenses, offset by a $0.3 million decrease in rent expense.

Current wording

Personnel-related research and development costs increased by $3.8 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 as a result of hiring personnel in our research and development organization. The increase in personnel-related research and development costs included an increase of $0.8 million in stock-based compensation expense. Facilities and overhead costs increased by $1.5 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023, mainly due to a $0.4 million increase in software license expense, a $0.4 million increase in recruiting costs of R&D personnel, a $0.3 million increase in depreciation expense, a $0.2 million increase in scientific conference costs, and a $0.5 million increase in allocated overhead expenses and a $0.2 million increase in rent expense.

Previous wording

During the three months ended June 30, 2024, KYV-101 program expenses increased by $10.2 million primarily attributable to a $9.0 million increase in CRO, CMO and other clinical trials costs as we continued to advance KYV-101 through clinical development across two broad areas of autoimmune disease: rheumatology and neurology. KYV-101 program CRO, CMC and other clinical trial costs during the three months ended June 30, 2024 also include $0.8 million of external expense related to the development of our Ingenui-T manufacturing process. Other change relates to a $1.2 million increase in professional consulting costs. KYV-201 expenses for the three months ended June 30, 2024 increased by $1.4 million, mainly due to an increase in CRO, CMO and other third-party preclinical studies, as we continued to advance KYV-201 through preclinical development. Other programs and research and development activities increased by $0.5 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023 and include expenses related to our preclinical activities, including reagents, lab supplies, outsourced research and development and professional consulting services.

Current wording

During the three months ended September 30, 2024, KYV-101 program expenses increased by $10.6 million primarily attributable to a $9.8 million increase in CRO, CMO and other clinical trials costs as we continued to advance KYV-101 through clinical development across two broad areas of autoimmune disease: rheumatology and neurology. KYV-101 program CRO, CMC and other clinical trial costs during the three months ended September 30, 2024 also include a $0.9 million increase of external expense related to the development of our Ingenui-T manufacturing process. Other change relates to a $0.8 million increase in professional consulting costs and a $0.1 million increase in other external costs. KYV-201 expenses for the three months ended September 30, 2024 decreased by $0.9 million, mainly due to an decrease in CRO, CMO and other third-party preclinical studies. Other programs and research and development activities increased by $0.1 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 and include expenses related to our preclinical activities, including reagents, lab supplies, outsourced research and development and professional consulting services.

Previous wording

General and administrative expenses increased $7.4 million, or 131%, from $5.6 million for the six months ended June 30, 2023 to $13.0 million for the six months ended June 30, 2024. The increase in general and administrative expenses was primarily attributable to a $3.8 million increase in salaries and benefits, including an increase of $1.6 million in stock-based compensation expense, an increase of $1.8 million in professional services costs related to legal, accounting and consulting services, and a $1.8 million increase in facilities and overhead costs. The increase in stock-based compensation expense for the six months ended June 30, 2024 includes a one-time stock-based compensation expense of $1.1 million in connection with the CEO note forgiveness. The increase in the facilities and overhead costs is primarily due to a $0.7 million increase in rent expense, a $0.4 million increase in software license expenses, and a $0.3 million increase in D&O insurance expenses.

Current wording

General and administrative expenses increased $7.0 million, or 263%, from $2.6 million for the three months ended September 30, 2023 to $9.6 million for the three months ended September 30, 2024. The increase in general and administrative expenses was primarily attributable to a $4.2 million increase in salaries and benefits, including an increase of $2.1 million in stock-based compensation expense, an increase of $2.4 million in professional services costs related to legal, accounting and consulting services, and a $0.7 million increase in facilities and overhead costs. The increase in stock-based compensation expense is primarily due to a one-time stock-based modification expense of $1.7 million related to the departure of the Former Chief Executive Officer (Former CEO) in September 2024. The increase in the facilities and overhead costs is primarily due to a $0.1 million increase in rent expense, a $0.2 million increase in D&O insurance expenses and a $0.1 million increase in software license expenses.

Previous wording

Interest income increased $6.8 million, from $0.6 million for the six months ended June 30, 2023 to $7.4 million for the six months ended June 30, 2024. The increase primarily relates to increased amounts invested in available-for-sale marketable securities and cash equivalents as well as an increase in interest rates on these securities during the six months ended June 30, 2024 compared to the six months ended June 30, 2023.

Current wording

Interest income increased $3.5 million, from $0.9 million for the three months ended September 30, 2023 to $4.4 million for the three months ended September 30, 2024. The increase primarily relates to increased amounts invested in available-for-sale marketable securities and cash equivalents following the IPO in February 2024.

Previous wording

Research and development expenses increased by $30.7 million, or 160%, from $19.1 million for the six months ended June 30, 2023 to $49.8 million for the six months ended June 30, 2024. License fees for the six months ended June 30, 2024 and 2023 mainly included expenses related to the minimum annual royalties of $0.3 million payable under our in-licensing agreements during the six months ended June 30, 2024. CRO, CMO and other third-party preclinical studies and clinical trial expenses increased by $22.6 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023, as we continued advancing our lead product candidate, KYV-101, through clinical development, and we continued to advance KYV-201 through preclinical development. Other research and development costs, including laboratory materials and supplies, decreased by $1.2 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023, mainly due to the timing of procurement of materials for our research and development activities.

Current wording

Research and development expenses increased by $46.2 million, or 141%, from $32.8 million for the nine months ended September 30, 2023 to $79.0 million for the nine months ended September 30, 2024. CRO, CMO and other third-party preclinical studies and clinical trial expenses increased by $33.2 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023, as we continued advancing our lead product candidate, KYV-101, through clinical development, and we continued to advance KYV-201 through preclinical development. Other research and development costs, including laboratory materials and supplies, decreased by $2.1 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023, mainly due to the procurement of materials for our research and development activities.

Previous wording

Personnel-related research and development costs increased by $7.1 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023 as a result of hiring personnel in our research and development organization. Our research and development headcount increased from 52 as of June 30, 2023 to 88 as of June 30, 2024. The increase in personnel-related research and development costs included an increase of $1.0 million in stock-based compensation expense. Facilities and overhead costs increased by $2.1 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023, mainly due to a $0.6 million increase in scientific conference expense, a $0.5 million increase in software license expense, a $0.4 million increase in depreciation expense, a $0.2 million increase in equipment repair expense and a $0.7 million increase in allocated overhead expenses, partially offset by a $0.3 million decrease in rent expense.

Current wording

Personnel-related research and development costs increased by $11.0 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 as a result of hiring personnel in our research and development organization. The increase in personnel-related research and development costs included an increase of $1.8 million in stock-based compensation expense. Facilities and overhead costs increased by $3.6 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023, mainly due to a $1.0 million increase in software license expense, a $0.8 million increase in scientific conference expense, a $0.7 million increase in depreciation expense, a $0.4 million increase in recruiting costs of R&D personnel, a $0.2 million increase in equipment repair expense and a $1.1 million increase in allocated overhead expenses, partially offset by a $0.2 million decrease in rent expense.

Previous wording

During the six months ended June 30, 2024, KYV-101 program expenses increased by $18.6 million, primarily attributable to a $16.4 million increase in CRO, CMO and other clinical trials costs as we continued to advance KYV-101 through clinical development across two broad areas of autoimmune disease: rheumatology and neurology. KYV-101 program CRO, CMO and other clinical trials costs during the six months ended June 30, 2024 also include $2.3 million of external expense related to the development of our Ingenui-T manufacturing process. Other change relates to a $2.1 million increase in profession consulting costs and a $0.2 million in other external costs for KYV-101. KYV-201 expenses for the six months ended June 30, 2024 increased by $1.9 million, mainly due to an increase in CRO, CMO and other third-party preclinical studies, as we continued to advance KYV-201 through preclinical development. Other programs and research and development activities increased by $1.0 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023 and include expenses related to our preclinical activities, including reagents, lab supplies, outsourced research and development and professional consulting services.

Current wording

During the nine months ended September 30, 2024, KYV-101 program expenses increased by $29.1 million, primarily attributable to a $24.0 million increase in CRO, CMO and other clinical trials costs as we continued to advance KYV-101 through clinical development across two broad areas of autoimmune disease: rheumatology and neurology. KYV-101 program CRO, CMO and other clinical trials costs during the nine months ended September 30, 2024 also include a $2.2 million increase in external expense related to the development of our Ingenui-T manufacturing process. Other change relates to a $2.8 million increase in profession consulting costs and a $0.1 million increase in other external costs for KYV-101. KYV-201 expenses for the nine months ended September 30, 2024 increased by $1.1 million, mainly due to an increase in CRO, CMO and other third-party preclinical studies, as we continued to advance KYV-201 through preclinical development. Other programs and research and development activities increased by $1.1 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 and include expenses related to our preclinical activities, including reagents, lab supplies, outsourced research and development and professional consulting services.

Previous wording

General and administrative expenses increased $3.2 million, or 111%, from $2.9 million for the three months ended June 30, 2023 to $6.1 million for the three months ended June 30, 2024. The increase in general and administrative expenses was primarily attributable to a $1.4 million increase in salaries and benefits, including an increase of $0.3 million in stock-based compensation expense, an increase of $0.7 million in professional services costs related to legal, accounting and consulting services, and a $1.1 million increase in facilities and overhead costs. The increase in the facilities and overhead costs is primarily due to a $0.5 million increase in rent expense, a $0.2 million increase in D&O insurance expenses and a $0.1 million increase in software license expenses.

Current wording

General and administrative expenses increased $14.3 million, or 173%, from $8.3 million for the nine months ended September 30, 2023 to $22.6 million for the nine months ended September 30, 2024. The increase in general and administrative expenses was primarily attributable to a $8.1 million increase in salaries and benefits, including an increase of $3.7 million in stock-based compensation expense, an increase of $4.2 million in professional services costs related to legal, accounting and consulting services, and a $2.4 million increase in facilities and overhead costs. The increase in stock-based compensation expense for the nine months ended September 30, 2024 includes a one-time stock-based compensation expense of $1.1 million in connection with the Former CEO note forgiveness in January 2024, as well as a one-time stock-based modification expense of $1.7 million related to the departure of the Former CEO in September 2024. The increase in the facilities and overhead costs is primarily due to a $0.8 million increase in rent expense, a $0.5 million increase in software license expenses, and a $0.5 million increase in D&O insurance expenses.

Previous wording

Interest income increased $4.4 million, from $0.3 million for the three months ended June 30, 2023 to $4.7 million for the three months ended June 30, 2024. The increase primarily relates to increased amounts invested in available-for-sale marketable securities and cash equivalents as well as an increase in interest rates on these securities during the three months ended June 30, 2024 compared to the three months ended June 30, 2023.

Current wording

Interest income increased $10.3 million, from $1.5 million for the nine months ended September 30, 2023 to $11.8 million for the nine months ended September 30, 2024. The increase primarily relates to increased amounts invested in available-for-sale marketable securities and cash equivalents following the IPO in February 2024, partially offset by a decrease in interest rates on these securities during the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023.

Previous wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. Through June 30, 2024, we have primarily funded our operations from sales of shares of our redeemable convertible preferred stock of $168.0 million, issuances of convertible notes of $2.0 million, an upfront payment of $17.5 million under the Gilead Agreement and net proceeds from the IPO of $336.2 million. As of June 30, 2024, we had $346.2 million in cash, cash equivalents and available-for-sale marketable securities.

Current wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. Through September 30, 2024, we have primarily funded our operations from sales of shares of our redeemable convertible preferred stock of $168.0 million, issuances of convertible notes of $2.0 million, an upfront payment of $17.5 million under the Gilead Agreement and net proceeds from the IPO of $336.2 million. As of September 30, 2024, we had $321.6 million in cash, cash equivalents and available-for-sale marketable securities.

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. As of June 30, 2024, we had an accumulated deficit of $191.5 million. Based on the current cash forecast, management has determined that our cash and cash equivalents and available-for-sale marketable securities of $346.2 million as of June 30, 2024 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. This forecast of cash resources and planned operations involves risks and uncertainties, and the actual amount of expenses could vary materially as a result of a number of factors.

Current wording

We have incurred significant losses and negative cash flows from operations since our inception. As of September 30, 2024, we had an accumulated deficit of $226.0 million. Based on the current cash forecast, management has determined that our cash and cash equivalents and available-for-sale marketable securities of $321.6 million as of September 30, 2024 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. This forecast of cash resources and planned operations involves risks and uncertainties, and the actual amount of expenses could vary materially as a result of a number of factors.

Previous wording

Net cash used in operating activities was $49.7 million and $22.7 million for the six months ended June 30, 2024 and 2023, respectively.

Current wording

Net cash used in operating activities was $77.2 million and $33.8 million for the nine months ended September 30, 2024 and 2023, respectively.

Previous wording

Cash used in operating activities for the six months ended June 30, 2024, was primarily due to our net loss of $55.5 million, decreased by non-cash charges of 3.2 million and increased by a net reduction of $2.6 million in our net operating assets and liabilities. The non-cash charges primarily consisted of a $3.6 million stock-based compensation expense, a $1.2 million non-cash lease expense and a $1.0 million depreciation and amortization expense, partially offset by $2.5 million of income related to the accretion of discounts on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to a decrease in operating lease liability of $1.1 million, a decrease in other non-current assets of $0.3 million and a decrease in accrued compensation of $0.1 million, offset by an increase in other current liabilities of $2.6 million, an increase in accounts payable by $1.0 million and an increase in prepaid expense and other current assets of $0.5 million.

Current wording

Cash used in operating activities for the nine months ended September 30, 2024, was primarily due to our net loss of $90.0 million, decreased by non-cash charges of 5.0 million and decreased by a net reduction of $7.8 million in our net operating assets and liabilities. The non-cash charges primarily consisted of a $7.0 million stock-based compensation expense, a $1.9 million non-cash lease expense and a $1.6 million depreciation and amortization expense, partially offset by $5.4 million of income related to the accretion of discounts on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to an increase in accounts payable of $6.0 million, an increase in other current liabilities of $3.3 million, an increase in accrued compensation of $1.6 million, partially offset by a decrease in operating lease liability of $1.8 million, an increase in in other non-current assets of $0.9 million and an increase in prepaid expense and other current assets of $0.7 million.

Previous wording

Cash used in operating activities for the six months ended June 30, 2023, was primarily due to our net loss of $24.2 million, decreased by non-cash charges of $2.5 million and increased by a net reduction of $1.0 million in our net operating assets and liabilities. The non-cash charges primarily consisted of a $0.9 million stock-based compensation expense, a $0.8 million non-cash lease expense and a $0.8 million depreciation and amortization expense, partially offset by $0.1 million of income related to the accretion of discounts on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to a decrease in prepaid expense and other current assets of $0.8 million, a decrease in operating lease liability of $0.8 million and a decrease in accrued compensation of $0.3 million, offset by a $0.6 million increase in accounts payable and $0.3 million increase in other current liabilities.

Current wording

Cash used in operating activities for the nine months ended September 30, 2023, was primarily due to our net loss of $39.7 million, decreased by non-cash charges of $3.4 million and decreased by a net increase of $2.4 million in our net operating assets and liabilities. Non-cash changes primarily consisted of a $1.4 million stock-based compensation expense, a $1.3 million non-cash lease expense and a $1.2 million depreciation and amortization expense, partially offset by $0.5 million of income related to the accretion of discounts on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to an increase in other liabilities of $2.3 million, an increase in accounts payable of $1.1 million as we increased our operations and spending and an increase in accrued compensation of $0.4 million, offset by a $1.2 million decrease in operating lease liability and a $0.2 million increase in prepaid expense and other current assets.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2024, was $190.8 million, which consisted of $225.2 million of purchases of available-for-sale marketable securities and $1.6 million of purchases of property and equipment, offset by $36.0 million in proceeds from maturities of available-for-sale marketable securities.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2024, was $190.1 million, which consisted of $362.8 million of purchases of available-for-sale marketable securities and $1.7 million of purchases of property and equipment, offset by $174.3 million in proceeds from maturities of available-for-sale marketable securities.

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2023, was $13.7 million, which consisted of $13.7 million in proceeds from maturities of available-for-sale marketable securities, partially offset by less than $0.1 million of purchases of property and equipment.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2023, was $40.5 million, which consisted of $53.9 million of purchases of available-for-sale marketable securities and $0.3 million of purchases of property and equipment, offset by $13.7 million in proceeds from maturities of available-for-sale marketable securities.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2024, was $337.5 million, which consisted of $341.2 million cash proceeds from the issuance of shares of our common stock in the IPO, net of underwriting discount and less than $0.1 million of proceeds from exercises of stock options, partially offset by $3.4 million payments for deferred offering costs and a payment of $0.5 million related to finance lease obligations.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2024, was $337.3 million, which consisted of $341.2 million cash proceeds from the issuance of shares of our common stock in the IPO, net of underwriting discount and $0.2 million of proceeds from exercises of stock options, partially offset by $3.4 million payments for deferred offering costs and a payment of $0.7 million related to finance lease obligations.

Previous wording

Net provided by financing activities for the six months ended June 30, 2023, was $24.8 million, which consisted of $25.1 million cash proceeds from the issuance of redeemable convertible preferred stock, net of issuance costs and less than $0.1 million of proceeds from exercises of stock options, partially offset by a payment of $0.4 million related to finance lease obligations.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2023, was $59.6 million, which consisted of $59.9 million net cash proceeds from our issuance of shares of Series B Preferred Stock and $0.4 million of proceeds from exercises of stock options, partially offset by a payment of $0.6 million related to finance lease obligations and payment of $0.2 million related to deferred initial public offering costs.

Previous wording

We enter into contracts in the normal course of business with CROs for clinical trials, with CMOs for clinical supplies manufacturing and with other vendors for preclinical studies, supplies and other products and services for operating purposes. These agreements generally provide for termination at the request of either party generally with less than one-year notice and, therefore, we believe that our non-cancellable obligations under these agreements are not material. We do not currently expect any of these agreements to be terminated and did not have any non-cancellable obligations under these agreements as of June 30, 2024.

Current wording

We enter into contracts in the normal course of business with CROs for clinical trials, with CMOs for clinical supplies manufacturing and with other vendors for preclinical studies, supplies and other products and services for operating purposes. These agreements generally provide for termination at the request of either party generally with less than one-year notice and, therefore, we believe that our non-cancellable obligations under these agreements are not material.

Previous wording

As of June 30, 2024, we leased approximately 68,000 square feet of office and laboratory space in Emeryville, California under operating leases which have terms through February 2027. We also have multiple leases for laboratory equipment with 36-month terms that are accounted for as finance leases. As of June 30, 2024, our non-cancellable lease obligations were $9.7 million and $1.5 million under operating and finance leases, respectively, of which $2.9 million and $1.0 million related to operating and finance leases, respectively, are due within the next 12 months.

Current wording

As of September 30, 2024, we leased approximately 68,000 square feet of office and laboratory space in Emeryville, California under operating leases which have terms through February 2027. We also have multiple leases for laboratory equipment with 36-month terms that are accounted for as finance leases. As of September 30, 2024, our non-cancellable lease obligations were $8.9 million and $1.3 million under operating and finance leases, respectively, of which $3.0 million and $0.9 million related to operating and finance leases, respectively, are due within the next 12 months.

Previous wording

Our significant accounting policies and critical accounting estimates are described in Note 2 to our audited financial statements for the year ended December 31, 2023 included in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 26, 2024. There have been no material changes to our significant accounting policies or critical accounting estimates during the six months ended June 30, 2024, except the fair value of our common stock is the closing price per share on NASDAQ at the grant date for stock-based awards granted as of and subsequent to the IPO.

Current wording

Our significant accounting policies and critical accounting estimates are described in Note 2 to our audited financial statements for the year ended December 31, 2023 included in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 26, 2024. There have been no material changes to our significant accounting policies or critical accounting estimates during the nine months ended September 30, 2024, except the fair value of our common stock is the closing price per share on NASDAQ at the grant date for stock-based awards granted as of and subsequent to the IPO.