ALUMIS INC.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001847367-25-000041
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001847367-25-000050
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 147 previous paragraphs and 148 current paragraphs.
77 unchanged; 56 reworded; 9 added; 8 removed; 6 previous and 6 current paragraphs rearranged.
Tables are not compared: 59 previous and 59 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
Results of Operations and Comprehensive Loss
Current report
Research and development expenses increased by $10.0 million, to $97.8 million for the three months ended September 30, 2025, from $87.8 million for the three months ended September 30, 2024.
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Current report
Research and development expenses increased by $124.9 million, to $303.2 million for the nine months ended September 30, 2025, from $178.4 million for the nine months ended September 30, 2024.
Current report
During the nine months ended September 30, 2024, milestones related to previously acquired IPR&D assets included a $23.0 million clinical milestone payment in connection with the FronThera Acquisition.
Current report
General and administrative expenses increased by $8.9 million, to $19.5 million for the three months ended September 30, 2025, from $10.6 million for the three months ended September 30, 2024.
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Current report
General and administrative expenses increased by $52.5 million, to $76.3 million for the nine months ended September 30, 2025, from $23.8 million for the nine months ended September 30, 2024.
Current report
A gain on bargain purchase of $187.9 million was recognized at the Closing Date of the ACELYRIN Merger. No such gain was recognized in any other reporting period.
Removed paragraphs (8)
Previous report
Results of Operations and Comprehensive Income (Loss)
Previous report
Research and development expenses increased by $60.2 million, to $108.8 million for the three months ended June 30, 2025, from $48.6 million for the three months ended June 30, 2024.
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Previous report
Research and development expenses increased by $114.9 million, to $205.4 million for the six months ended June 30, 2025, from $90.5 million for the six months ended June 30, 2024.
Previous report
General and administrative expenses increased by $26.9 million, to $34.5 million for the three months ended June 30, 2025, from $7.6 million for the three months ended June 30, 2024.
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Previous report
General and administrative expenses increased by $43.5 million, to $56.7 million for the six months ended June 30, 2025, from $13.2 million for the six months ended June 30, 2024.
Previous report
Net cash provided by financing activities for the six months ended June 30, 2024 of $257.2 million was related to net proceeds of $258.5 million from the issuance of our Series C redeemable convertible preferred stock and related derivative
Reworded paragraphs (56)
Previous wording
Since our inception, we have devoted substantially all of our efforts to organizing our company, hiring personnel, business planning, acquiring and developing our product candidates, performing research and development, conducting preclinical studies and clinical trials, establishing and protecting our intellectual property portfolio, raising capital and providing general and administrative support for these activities. We do not have any products approved for sale and have not generated any revenue from product sales. We expect to continue to incur significant and increasing expenses and increasing substantial losses for the foreseeable future as we continue our development of and seek regulatory approvals for our product candidates and commercialize any approved products, seek to expand our product pipeline and invest in our expanded organization following the ACELYRIN Merger. Our ability to achieve and sustain profitability will depend on our ability to successfully develop, obtain regulatory approval for and commercialize our product candidates. There can be no assurance that we will ever achieve profitability, or if achieved, that the revenue or profitability will be sustained on a continuing basis.
Current wording
Since our inception, we have devoted substantially all of our efforts to organizing our company, hiring personnel, business planning, acquiring and developing our product candidates, performing research and development, conducting preclinical studies and clinical trials, establishing and protecting our intellectual property portfolio, raising capital, integrating the acquired ACELYRIN business and personnel, and providing general and administrative support for these activities. We do not have any products approved for sale and have not generated any revenue from product sales. We expect to continue to incur significant and increasing expenses and increasing substantial losses for the foreseeable future as we continue our development of and seek regulatory approvals for our product candidates and commercialize any approved products, seek to expand our product pipeline and invest in our expanded organization following the ACELYRIN Merger. Our ability to achieve and sustain profitability will depend on our ability to successfully develop, obtain regulatory approval for and commercialize our product candidates. There can be no assurance that we will ever achieve profitability, or if achieved, that the revenue or profitability will be sustained on a continuing basis.
Previous wording
We have incurred significant operating losses and negative cash flows since our inception. Our net income (loss) for the three and six months ended June 30, 2025 and 2024 was $59.3 million, $(56.5) million, $(39.6) million and $(106.4) million, respectively. As of June 30, 2025, we had an accumulated deficit of $698.2 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development efforts, including acquisitions of in-process research and development assets, and, to a lesser extent, from general and administrative costs associated with our operations. Our net losses and operating losses may fluctuate from quarter to quarter and year to year depending primarily on the timing of acquisition of any new product candidates, the timing of our preclinical studies and clinical trials, our other research and development expenses, and the timing and amount of any milestone or royalty payments due under our existing or future license agreements. In addition, we have incurred and will continue to incur substantial expenses associated with the ACELYRIN Merger and the integration and development activities related to the acquired ACELYRIN business. We have incurred and will continue to incur additional costs associated with operating as a public company, including significant legal, audit, accounting, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer liability insurance costs, investor and public relations costs, and other expenses that we did not incur as a private company.
Current wording
We have incurred significant operating losses and negative cash flows since our inception. Our net loss for the three and nine months ended September 30, 2025 and 2024 was $110.8 million, $93.1 million, $150.4 million and $199.5 million, respectively. As of September 30, 2025, we had an accumulated deficit of $808.9 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development efforts, including acquisitions of in-process research and development assets, and, to a lesser extent, from general and administrative costs associated with our operations. Our net losses and operating losses may fluctuate from quarter to quarter and year to year depending primarily on the timing of acquisition of any new product candidates, the timing of our preclinical studies and clinical trials, our other research and development expenses, and the timing and amount of any milestone or royalty payments due under our existing or future license agreements. In addition, we have incurred and will continue to incur substantial expenses associated with the ACELYRIN Merger and the integration and development activities related to the acquired ACELYRIN business. We have incurred and will continue to incur additional costs associated with operating as a public company, including significant legal, audit, accounting, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer liability insurance costs, investor and public relations costs, and other expenses that we did not incur as a private company.
Previous wording
We do not currently own or operate any manufacturing facility. We rely on CMOs to produce our product candidates in accordance with the U.S. Food and Drug Administration’s (the “FDA”) current Good Manufacturing Practices (“cGMP”) regulations for use in our clinical studies. We have entered into development and manufacturing agreements with various CMOs relating to process development, manufacturing of drug substance and drug product, and quality testing of our product candidates. We expect to rely on our CMOs in the future for the manufacturing of our product candidates in order to expedite readiness for future clinical trials. Most of these CMOs have demonstrated capability in preparation of materials for commercialization. Additionally, we may decide to build our own manufacturing facility in the future to provide us greater flexibility and control over our clinical or commercial manufacturing needs.
Current wording
We do not currently own or operate any manufacturing facility. We rely on CMOs to produce our product candidates in accordance with the U.S. Food and Drug Administration’s (the “FDA”) current Good Manufacturing Practices (“cGMP”) regulations for use in our clinical studies. We have entered into development and manufacturing agreements with various CMOs relating to process development, manufacturing of drug substance and drug product, and quality testing of our product candidates. We expect to rely on our CMOs in the future for the manufacturing of our product candidates in order to expedite readiness for future clinical trials. Most of these CMOs have demonstrated capability in preparation of materials for commercialization. Additionally, we may decide to build our own manufacturing facility in the future to provide us with greater flexibility and control over our clinical or commercial manufacturing needs.
Previous wording
On July 1, 2024, we completed our IPO, pursuant to which we issued and sold 13,125,000 shares of our common stock at $16.00 price per share to the public. Net proceeds from the IPO were $193.3 million, after deducting underwriting discounts and commissions and other offering costs totaling $16.7 million. In connection with the IPO, an existing investor and a holder of more than 5% of our capital stock, purchased an additional 2,500,000 shares of our common stock at the IPO price per share for total gross and net proceeds of $40.0 million in a private placement transaction. The closing of the Concurrent Private Placement was contingent on the closing of the IPO. The sale of such shares is not registered under the Securities Act, and as such, the shares may not be offered or sold absent registration or an applicable exemption from registration. The shares sold in connection with the Concurrent Private Placement are subject to existing resale registration rights. The Concurrent Private Placement closed on July 17, 2024.
Current wording
On July 1, 2024, we completed our IPO, pursuant to which we issued and sold 13,125,000 shares of our common stock at $16.00 price per share to the public. Net proceeds from the IPO were $193.3 million, after deducting underwriting discounts and commissions and other offering costs totaling $16.7 million. In connection with the IPO, an existing investor and a holder of more than 5% of our capital stock, purchased an additional 2,500,000 shares of our common stock at the IPO price per share for total gross and net proceeds of $40.0 million from the Concurrent Private Placement. The closing of the Concurrent Private Placement was contingent on the closing of the IPO. The sale of such shares is not registered under the Securities Act, and as such, the shares may not be offered or sold absent registration or an applicable exemption from registration. The shares sold in connection with the Concurrent Private Placement are subject to existing resale registration rights. The Concurrent Private Placement closed on July 17, 2024.
Previous wording
Our results of operations include the accounts of ACELYRIN and its wholly owned subsidiary WH2, LLC after the closing of the Merger, and the accounts of Merger Sub from its incorporation in January 2025 until the ACELYRIN Merger. Accordingly, the results discussed below were impacted by the timing of the ACELYRIN Merger. WH2, LLC has not had any operations or any balances from its inception. See Note 2 to our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional information.
Current wording
Our results of operations include the accounts of our wholly owned subsidiaries ACELYRIN and WH2, LLC after the closing of the Merger, and the accounts of Merger Sub from its incorporation in January 2025 until the ACELYRIN Merger. Accordingly, the results discussed below were impacted by the timing of the ACELYRIN Merger. WH2, LLC has not had any operations or any balances from its inception. See Note 2 to our unaudited condensed consolidated financial statements included in Part I, Item 1. of this Quarterly Report on Form 10-Q for additional information.
Previous wording
Our business and results of operations may be affected by worldwide economic conditions, which may continue to be impacted by global macroeconomic challenges and uncertainty in the markets, including severely diminished liquidity and credit availability, rising inflation and monetary supply shifts, rising interest rates, labor shortages, declines in consumer confidence, declines in economic growth, increases in unemployment rates, recession risks and uncertainty about economic and geopolitical stability (for example, related to the ongoing conflicts in Ukraine and Israel and the surrounding areas). Further, the United States and other countries have imposed and may continue to impose new trade restrictions and export regulations, have levied tariffs and taxes on certain goods, and could significantly increase tariffs on a broad array of goods. For example, the current Trump administration has proposed or enacted tariffs and substantial changes to trade policies, which could adversely affect our business, including imposing tariffs on certain foreign products, most recently from China, that have and may result in retaliatory tariffs on U.S. goods and services. The effect of macroeconomic conditions may not be fully reflected in our results of operations until future periods. Moreover, negative macroeconomic conditions could adversely impact our ability to obtain financing in the future on terms acceptable to us, or at all. To date, the macroeconomic trends discussed above have not had a material adverse impact on our business, financial condition or results of operations. If, however, economic uncertainty increases or the global economy worsens, our business, financial condition and results of operations may be harmed.
Current wording
Our business and results of operations may be affected by worldwide economic conditions, which may continue to be impacted by global macroeconomic challenges and uncertainty in the markets, including severely diminished liquidity and credit availability, rising inflation and monetary supply shifts, rising interest rates, labor shortages, declines in consumer confidence, declines in economic growth, increases in unemployment rates, recession risks and uncertainty about economic and geopolitical stability (for example, related to the ongoing conflicts in Ukraine and the evolving U.S. and ex-U.S. tariff landscape). Further, the United States and other countries have imposed and may continue to impose new trade restrictions and export regulations, have levied tariffs and taxes on certain goods, and could continue to significantly increase tariffs on a broad array of goods. For example, the current Trump administration has proposed or enacted tariffs and substantial changes to trade policies that have created a dynamic and unpredictable trade landscape, which could adversely affect our business, including proposing or imposing tariffs on certain foreign products, including from China, that have resulted and may continue to result in retaliatory tariffs on U.S. goods and services. The effect of macroeconomic conditions may not be fully reflected in our results of operations until future periods. Moreover, negative macroeconomic conditions could adversely impact our ability to obtain financing in the future on terms acceptable to us, or at all. To date, the macroeconomic trends discussed above have not had a material adverse impact on our business, financial condition or results of operations. If, however, economic uncertainty increases or the global economy worsens, our business, financial condition and results of operations may be harmed.
Previous wording
In March 2025, Kaken made an upfront, non-refundable payment of $20.0 million to us. In addition, Kaken will pay us an aggregate of $20.0 million towards global development costs of envu in the dermatology field through the end of 2026 and thereafter will pay a specified share of development costs applicable to the dermatology field, and for any field for which Kaken exercises its option, subject to Kaken's right to opt out of cost-sharing in certain indications in specified circumstances. In addition, Kaken would pay us up to an aggregate of $36.0 million upon the achievement of regulatory
Current wording
In March 2025, Kaken made an upfront, non-refundable payment of $20.0 million to us. In addition, Kaken will pay us an aggregate of $20.0 million towards global development costs of envu in the dermatology field through the end of 2026 and thereafter will pay a specified share of development costs applicable to the dermatology field, and for any field for which Kaken exercises its option, subject to Kaken's right to opt out of cost-sharing in certain indications in specified
Previous wording
milestones and upon Kaken’s exercise of its field expansion options for the rheumatology and gastrointestinal fields. In addition, we are entitled to receive aggregate payments of up to ¥15.5 billion upon the achievement of commercial milestones, plus tiered royalties at percentages ranging from the low double digits into the twenties on aggregate net sales of envu in Japan.
Current wording
circumstances. In addition, Kaken would pay us up to an aggregate of $36.0 million upon the achievement of regulatory milestones and upon Kaken’s exercise of its field expansion options for the rheumatology and gastrointestinal fields. In addition, we are entitled to receive aggregate payments of up to ¥15.5 billion upon the achievement of commercial milestones, plus tiered royalties at percentages ranging from the low double digits into the twenties on aggregate net sales of envu in Japan.
Previous wording
We expect that our general and administrative expenses will increase substantially in the future as a result of expanding our operations, including hiring personnel, preparing for potential commercialization of our product candidates and facility occupancy costs, and integrating ACELYRIN’s operations. We also expect an increase in costs associated with being a public company, including costs related to accounting, audit, legal, consulting fees, regulatory and tax-related services associated with maintaining compliance with applicable Nasdaq and SEC requirements, additional director and officer insurance costs, and investor and public relations costs.
Current wording
We expect that our general and administrative expenses will increase substantially in the future as a result of expanding our operations, including hiring personnel, preparing for potential commercialization of our product candidates and facility occupancy costs, and integrating ACELYRIN’s historical operations. We also expect an increase in costs associated with being a public company, including costs related to accounting, audit, legal, consulting fees, regulatory and tax-related services associated with maintaining compliance with applicable Nasdaq and SEC requirements, additional director and officer insurance costs, and investor and public relations costs.
Previous wording
The gain on bargain purchase represents the excess of fair value of net assets acquired in the ACELYRIN Merger over the purchase consideration and was recognized as other income in the unaudited condensed consolidated statements of operations and comprehensive income (loss) as of the Closing Date of the ACELYRIN Merger.
Current wording
At the closing of the ACELYRIN Merger in May 2025, we recognized a gain on bargain purchase which represents the excess of fair value of net assets acquired in the ACELYRIN Merger over the purchase consideration on the Closing Date. The gain on bargain purchase was recognized as other income in the unaudited condensed consolidated statements of operations and comprehensive loss as of the Closing Date of the ACELYRIN Merger. See Note 3 to our unaudited condensed consolidated financial statements in Part I, Item 1. of this Quarterly Report on Form 10-Q for additional information.
Previous wording
In March 2024, in connection with our redeemable convertible preferred stock financings, we issued options to purchase additional shares of redeemable convertible preferred stock at a specified price, which were accounted for as derivative liabilities. Changes in fair value of these derivative liabilities were included in the other income (loss) in the condensed consolidated statement of operations and comprehensive income (loss) for each reporting period until the derivatives were exercised or expired.
Current wording
In March 2024, in connection with our redeemable convertible preferred stock financings, we issued options to purchase additional shares of redeemable convertible preferred stock at a specified price, which were accounted for as derivative liabilities. Changes in fair value of these derivative liabilities were included in the other income (loss) in the condensed consolidated statement of operations and comprehensive loss for each reporting period until the derivatives were exercised or expired.
Previous wording
The following tables summarize our results of operations for the three and six months ended June 30, 2025 and 2024 (dollars in thousands):
Current wording
The following tables summarize our results of operations for the three and nine months ended September 30, 2025 and 2024 (dollars in thousands):
Previous wording
Forthe three and six months ended June 30, 2025, we recognized license revenue of zero and $17.4 million, respectively, and service and other revenue of $2.7 million related to the Collaboration Agreement with Kaken. We expect to recognize development services and other revenue through the term of the Collaboration Agreement as the services are performed.
Current wording
Forthe three and nine months ended September 30, 2025, we recognized license revenue of zero and $17.4 million, respectively, and collaboration revenue of $2.1 million and $4.7 million, respectively, related to the Collaboration Agreement with Kaken. We expect to recognize revenue under the Development Services Obligation and Manufacturing Services Obligation through the term of the Collaboration Agreement as the services are performed.
Previous wording
The following tables summarize our external and internal research and development expenses for the three and six months ended June 30, 2025 and 2024 (dollars in thousands):
Current wording
The following tables summarize our external and internal research and development expenses for the three and nine months ended September 30, 2025 and 2024 (dollars in thousands):
Previous wording
CRO, CMO and clinical trials expenses increased by $39.2 million, to $66.1 million for the three months ended June 30, 2025, from $26.8 million for the three months ended June 30, 2024, primarily due to an increase in clinical trial and CRO expenses related to the progression of our clinical trials for envu and other programs.
Current wording
CRO, CMO and clinical trials expenses increased by $17.0 million, to $56.5 million for the three months ended September 30, 2025, from $39.5 million for the three months ended September 30, 2024, primarily due to an increase in clinical trial and CRO expenses related to the progression of our clinical trials for envu and other programs, including costs to support acceleration of clinical trial activities for our Phase 3 ONWARD clinical program.
Previous wording
Professional consulting services expenses increased by $2.7 million, to $7.4 million for the three months ended June 30, 2025, from $4.8 million for the three months ended June 30, 2024, due to services to support our clinical trial for envu and other programs.
Current wording
Professional consulting services expenses increased by $3.7 million, to $8.2 million for the three months ended September 30, 2025, from $4.5 million for the three months ended September 30, 2024, due to services to support our clinical trial for envu and other programs.
Previous wording
Other research and development costs decreased by $0.6 million, to $3.0 million for the three months ended June 30, 2025, from $3.6 million for the three months ended June 30, 2024, primarily due to the timing of preclinical studies.
Current wording
Other research and development costs decreased by $1.3 million, to $1.6 million for the three months ended September 30, 2025, from $2.9 million for the three months ended September 30, 2024, primarily due to the timing of preclinical studies.
Previous wording
Personnel-related costs increased by $16.7 million, to $26.8 million for the three months ended June 30, 2025, from $10.1 million for the three months ended June 30, 2024, primarily due to severance costs related to the ACELYRIN Merger and increased research and development headcount, and included an increase in stock-based compensation expense of $5.6 million resulting from equity awards assumed in the ACELYRIN Merger and additional stock options granted.
Current wording
Personnel-related costs increased by $11.4 million, to $24.9 million for the three months ended September 30, 2025, from $13.5 million for the three months ended September 30, 2024, primarily due to severance costs related to the ACELYRIN Merger and an increase in research and development headcount, and included an increase in stock-based compensation expense of $2.1 million resulting from equity awards assumed in the ACELYRIN Merger and additional stock options granted.
Previous wording
Facilities and overhead costs increased by $2.2 million, to $5.4 million for the three months ended June 30, 2025, from $3.2 million for the three months ended June 30, 2024, primarily due to an increase in software license costs and information technology, and facilities expenses allocated to research and development activities.
Current wording
Facilities and overhead costs increased by $2.2 million, to $6.7 million for the three months ended September 30, 2025, from $4.5 million for the three months ended September 30, 2024, primarily due to an increase in information technology and facilities expenses allocated to research and development activities.
Previous wording
CRO, CMO and clinical trials expenses increased by $80.0 million, to $131.2 million for the six months ended June 30, 2025, from $51.1 million for the six months ended June 30, 2024 primarily due to an increase in clinical trial and CRO expenses related to the progression of our clinical trials for envu and other programs and an increase in CMO expenses associated with manufacturing of clinical supplies to support our trials.
Current wording
CRO, CMO and clinical trials expenses increased by $97.0 million, to $187.6 million for the nine months ended September 30, 2025, from $90.6 million for the nine months ended September 30, 2024 primarily due to an increase in clinical trial and CRO expenses related to the progression of our clinical trials for envu and other programs, including programs related to the ACELYRIN Merger, and an increase in CMO expenses associated with manufacturing of clinical supplies to support our trials.
Previous wording
Professional consulting services expenses increased by $5.5 million, to $13.8 million for the six months ended June 30, 2025, from $8.3 million for the six months ended June 30, 2024, due to services to support our clinical trial for envu and other programs.
Current wording
Professional consulting services expenses increased by $9.3 million, to $22.0 million for the nine months ended September 30, 2025, from $12.8 million for the nine months ended September 30, 2024, due to services to support our clinical trial for envu and other programs.
Previous wording
Other research and development costs decreased by $0.3 million, to $5.3 million for the six months ended June 30, 2025, from $5.6 million for the six months ended June 30, 2024, primarily due to timing of preclinical studies.
Current wording
Other research and development costs decreased by $1.6 million, to $6.9 million for the nine months ended September 30, 2025, from $8.5 million for the nine months ended September 30, 2024, primarily due to timing of preclinical studies.
Previous wording
Personnel-related costs increased by $25.3 million, to $44.5 million for the six months ended June 30, 2025, from $19.2 million for the six months ended June 30, 2024, primarily due to severance costs related to the ACELYRIN Merger and increased research and development headcount, and included an increase in stock-based compensation expense of $7.9 million resulting from equity awards assumed in the ACELYRIN Merger and additional stock options granted.
Current wording
Personnel-related costs increased by $36.6 million, to $69.3 million for the nine months ended September 30, 2025, from $32.7 million for the nine months ended September 30, 2024, primarily due to severance costs related to the ACELYRIN Merger and an increase in research and development headcount, and included an increase in stock-based compensation expense of $9.9 million resulting from equity awards assumed in the ACELYRIN Merger and additional stock options granted.
Previous wording
Facilities and overhead costs increased by $4.3 million, to $10.6 million for the six months ended June 30, 2025, from $6.3 million for the six months ended June 30, 2024, primarily due to an increase in software license costs and information technology, and facilities expenses allocated to research and development activities.
Current wording
Facilities and overhead costs increased by $6.5 million, to $17.3 million for the nine months ended September 30, 2025, from $10.8 million for the nine months ended September 30, 2024, primarily due to an increase in information technology and facilities expenses allocated to research and development activities and an increase in software license costs.
Previous wording
The following table summarizes our external costs by program for the three and six months ended June 30, 2025 and 2024 (dollars in thousands):
Current wording
The following table summarizes our external costs by program for the three and nine months ended September 30, 2025 and 2024 (dollars in thousands):
Previous wording
Personnel-related expenses increased by $17.7 million, to $21.6 million for the three months ended June 30, 2025, from $3.9 million for the three months ended June 30, 2024, primarily due severance costs related to the ACELYRIN Merger and increased general and administrative headcount, and included an increase in stock-based compensation expense of $9.9 million resulting from equity awards assumed in the ACELYRIN Merger and additional stock options granted.
Current wording
Personnel-related expenses increased by $4.6 million, to $11.0 million for the three months ended September 30, 2025, from $6.4 million for the three months ended September 30, 2024, primarily due severance costs related to the ACELYRIN Merger and increased general and administrative headcount and included an increase in stock-based compensation expense of $0.4 million.
Previous wording
Professional consulting services expenses increased by $22.4 million, to $27.2 million for the six months ended June 30, 2025, from $4.8 million for the six months ended June 30, 2024, primarily due to ACELYRIN Merger transaction costs, and an increase in consulting, legal, accounting, audit and tax services to support our growth, public company requirements and business development.
Current wording
Professional consulting services and other expenses increased by $4.3 million, to $8.0 million for the three months ended September 30, 2025, from $3.7 million for the three months ended September 30, 2024, primarily due to a loss reserve and an increase in consulting, accounting, audit and tax services to support our growth, public company requirements and business development.
Previous wording
Personnel-related expenses increased by $21.6 million, to $28.9 million for the six months ended June 30, 2025, from $7.4 million for the six months ended June 30, 2024, primarily due to severance costs related to the ACELYRIN Merger and increased general and administrative headcount, and included an increase in stock-based compensation expense of $12.0 million resulting from equity awards assumed in the ACELYRIN Merger and additional stock options granted.
Current wording
Personnel-related expenses increased by $26.1 million, to $39.9 million for the nine months ended September 30, 2025, from $13.8 million for the nine months ended September 30, 2024, primarily due to severance costs related to the ACELYRIN Merger and increased general and administrative headcount, and included an increase in stock-based compensation expense of $12.4 million resulting from equity awards assumed in the ACELYRIN Merger and additional stock options granted.
Previous wording
Professional consulting services expenses increased by $9.9 million, to $12.8 million for the three months ended June 30, 2025, from $2.8 million for the three months ended June 30, 2024, primarily due to ACELYRIN Merger transaction costs, and an increase in consulting, legal, accounting, audit and tax services to support our growth, public company requirements and business development.
Current wording
Professional consulting services and other expenses increased by $26.7 million, to $35.3 million for the nine months ended September 30, 2025, from $8.6 million for the nine months ended September 30, 2024, primarily due to ACELYRIN Merger transaction costs, a loss reserve and an increase in consulting, legal, accounting, audit and tax services to support our growth, public company requirements and business development.
Previous wording
Other income (expense), net increased by $191.7 million, to $191.3 million other income, net for the three months ended June 30, 2025, from $0.4 million other expense, net for the three months ended June 30, 2024. Other income (expense), net increased by $196.5 million, to $193.9 million other income, net for the six months ended June 30, 2025, from $2.6 million other expense, net for the six months ended June 30, 2024.
Current wording
Other income (expense), net decreased by $0.7 million, to $4.5 million for the three months ended September 30, 2025, from $5.3 million for the three months ended September 30, 2024. Other income (expense), net increased by $195.7 million, to $198.4 million for the nine months ended September 30, 2025, from $2.7 million for the nine months ended September 30, 2024.
Previous wording
Interest income increased by $1.5 million, to $3.4 million for the three months ended June 30, 2025, from $2.0 million for the three months ended June 30, 2024, primarily as a result of higher balances of cash equivalents and marketable securities. Interest income increased by $3.2 million, to $6.0 million for the six months ended June 30, 2025, from $2.8 million for the six months ended June 30, 2024, primarily as a result of higher balances of cash equivalents and marketable securities.
Current wording
Interest income decreased by $0.7 million, to $4.6 million for the three months ended September 30, 2025, from $5.3 million for the three months ended September 30, 2024, primarily as a result of lower yields on cash equivalents and marketable securities held. Interest income increased by $2.5 million, to $10.6 million for the nine months ended September 30, 2025, from $8.2 million for the nine months ended September 30, 2024, primarily as a result of higher balances of cash equivalents and marketable securities.
Previous wording
We recognized a change in fair value of a derivative liability loss of $2.3 million and $5.4 million for the three and six months ended June 30, 2024, respectively related to the derivative liability recognized in connection with our Series C redeemable convertible preferred stock financing entered into in March 2024. The derivative liability was re-measured at fair value and settled in May 2024, when we closed the second tranche of the Series C financing. See Note 4 to our unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional information.
Current wording
We recognized a change in fair value of a derivative liability loss of zero and $5.4 million for the three and nine months ended September 30, 2024, respectively related to the derivative liability recognized in connection with our Series C redeemable convertible preferred stock financing entered into in March 2024. The derivative liability was re-measured at fair value and settled in May 2024, when we closed the second tranche of the Series C financing. See Note 4 to our unaudited condensed consolidated financial statements in Part I, Item 1. of this Quarterly Report on Form 10-Q for additional information.
Previous wording
Income tax benefit was $8.6 million for the three and six months ended June 30, 2025 as compared to zero for the three and six months ended June 30, 2024. The income tax benefit was related to the realization of deferred tax assets and valuation allowance release as a result of the ACELYRIN Merger.
Current wording
Income tax benefit was zero and $8.6 million for the three and nine months ended September 30, 2025, respectively, as compared to zero for the three and nine months ended September 30, 2024. The income tax benefit was related to the realization of deferred tax assets and valuation allowance release as a result of the ACELYRIN Merger.
Previous wording
Based on our current operating plan, our existing cash, cash equivalents and marketable securities of $486.3 million as of June 30, 2025, will be sufficient to meet our operating and capital requirements for at least 12 months from the date of issuance of the unaudited condensed consolidated financial statements included in Part I. Item 1. of this Quarterly Report on Form 10-Q. We expect to continue to incur substantial losses for the foreseeable future, and our transition to profitability will depend upon successful development, approval and commercialization of our product candidates and upon achievement of sufficient revenues to support our cost structure. We do not expect to generate any revenue from commercial product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates. We may never achieve profitability, and unless we do and until then, we will need to continue to raise additional capital. We will need to raise significant additional capital to fund ongoing research and development activities and maintain future operations. We plan to monitor expenses and may raise additional capital through a combination of public and private equity, debt financings, strategic alliances, and 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, on the terms which are favorable, we could be required to delay, scale back, or abandon some or all of our planned development programs and other operations, which could materially harm our business, financial condition and results of operations.
Current wording
Based on our current operating plan, our existing cash, cash equivalents and marketable securities of $377.7 million as of September 30, 2025, will be sufficient to meet our operating and capital requirements for at least 12 months from the date of issuance of the unaudited condensed consolidated financial statements included in Part I. Item 1. of this Quarterly Report on Form 10-Q. We expect to continue to incur substantial losses for the foreseeable future, and our transition to profitability will depend upon successful development, approval and commercialization of our product candidates and upon achievement of sufficient revenues to support our cost structure. We do not expect to generate any revenue from commercial product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates. We may never achieve profitability, and unless we do and until then, we will need to continue to raise additional capital. We will need to raise significant additional capital to fund ongoing research and development activities and maintain future operations. We continuously monitor and, where necessary, may reduce our operating expenses in response to our clinical development progress and our ability and need to raise additional capital through a combination of public and private equity, debt financings, strategic alliances, and licensing arrangements. For example, should any of our ongoing trials not meet our clinical development objectives, we may scale back or discontinue related activities and reallocate our working capital to extend our ability to meet our operating and capital requirements. Our ability to access capital when needed is not assured and, if capital is not available to us when, and in the amounts, needed, on the terms which are favorable, we could be required to delay, scale back, or abandon some or all of our planned development programs and other operations, which could materially harm our business, financial condition and results of operations.
Previous wording
Our primary uses of cash are to fund our operations, which consist primarily of research and development expenditures related to our programs and, to a lesser extent, general and administrative expenditures. We anticipate that we will continue to incur significant and increasing expenses for the foreseeable future as we continue to advance our product candidates, expand our corporate infrastructure, including the costs associated with being a public company, further our research and development initiatives for our product candidates, and incur costs associated with potential commercialization. In addition, we anticipate committing substantial capital resources to the integration and development activities related to the acquired ACELYRIN business. We are subject to all of the risks typically related to the development of new drug candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We anticipate that we will need substantial additional funding in connection with our continuing operations.
Current wording
expand our corporate infrastructure, including the costs associated with being a public company, further our research and development initiatives for our product candidates, and incur costs associated with potential commercialization. In addition, we anticipate committing substantial capital resources to the integration and development activities related to the acquired ACELYRIN business. We are subject to all of the risks typically related to the development of new drug candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We anticipate that we will need substantial additional funding in connection with our continuing operations.
Previous wording
We do not have any products approved for sale and have not generated any revenue from product sales since our inception. We do not expect to generate revenue from any product candidates that we develop until we obtain regulatory approval for one or more of such product candidates and commercialize our products or enter into collaboration agreements with third parties. Because of the numerous risks and uncertainties associated with biopharmaceutical product development, we may never achieve or sustain profitability and, unless and until we are able to develop and commercialize our product candidates, we will need to continue to raise additional capital. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through public or private equity or debt financings, or potentially other capital sources, such as collaboration or licensing arrangements with third parties or other strategic transactions. There are no assurances that we will be successful in obtaining an adequate level of financing to support our business plans when needed on acceptable 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.
Current wording
We do not have any products approved for sale and have not generated any revenue from product sales since our inception. We do not expect to generate revenue from any product candidates that we develop until we obtain regulatory approval for one or more of such product candidates and commercialize our products or enter into collaboration agreements with third parties. Because of the numerous risks and uncertainties associated with biopharmaceutical product development, we may never achieve or sustain profitability and, unless and until we are able to develop and commercialize our product candidates, we will need to continue to raise additional capital. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through public or private equity or debt financings, or potentially other capital sources, such as collaboration or licensing arrangements with third parties or other strategic transactions. There are no assurances that we will be successful in obtaining an adequate level of financing to support our business plans when needed on acceptable 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. If we are unable to raise capital as and when needed, or on attractive terms, we may have to significantly delay, reduce, or discontinue the development and commercialization of our product candidates or scale back or terminate our pursuit of new in-licenses and acquisitions.
Previous wording
The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
Net cash used in operating activities was $186.7 million and $96.5 million for the six months ended June 30, 2025 and 2024, respectively. Net cash used in operating activities for the six months ended June 30, 2025 was due to our net income (loss) for the period of $(39.6) million and non-cash items totaling $162.1 million partially offset by changes in operating assets and liabilities of $15.0 million. Non-cash items included $187.9 million related to gain on bargain purchase in connection with the ACELYRIN Merger and net accretion of discounts on marketable securities of $2.2 million, partially offset by $25.6 million related to stock-based compensation expense, $1.7 million related to depreciation and amortization and $0.6 million related to non-cash lease expense. The changes in operating assets and liabilities included an increase of $11.0 million in research and development accrued expenses, a decrease of $7.4 million in research and development prepaid expenses, an increase of $6.5 million in other accrued expenses and current liabilities, an increase of $2.6 million in deferred revenue, an increase of $0.2 million in other liabilities, non-current, and a decrease of $0.1 million in other prepaid expenses and other assets, partially offset by a decrease of $8.6 million in deferred income tax liability, an increase of $1.7 million in other assets, non-current, a decrease of $1.3 million in operating lease liabilities and a decrease of $1.2 million in accounts payable.
Current wording
Net cash used in operating activities was $297.6 million and $180.3 million for the nine months ended September 30, 2025 and 2024, respectively. Net cash used in operating activities for the nine months ended September 30, 2025 was due to our net loss for the period of $150.4 million and non-cash items totaling $152.0 million partially offset by changes in operating assets and liabilities of $5.0 million. Non-cash items included $187.9 million related to gain on bargain purchase in connection with the ACELYRIN Merger and net accretion of discounts on marketable securities of $3.9 million, partially offset by $35.4 million related to stock-based compensation expense, $2.6 million related to depreciation and amortization, $1.2 million related to non-cash lease expense and $0.5 million related to impairment of long-lived assets. The changes in operating assets and liabilities included a decrease of $13.3 million in other prepaid expenses and other assets, a decrease of $9.4 million in research and development prepaid expenses, an increase of $4.9 million in research and development accrued expenses, an increase of $2.6 million in other accrued expenses and current liabilities, an increase of $1.9 million in deferred revenue, and an increase of $0.2 million in other liabilities, non-current, partially offset by a decrease of $11.6 million in accounts payable, a decrease of $8.6 million in deferred income tax liability, an increase of $5.1 million in other assets, non-current, and a decrease of $2.3 million in operating lease liabilities.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2024 was due to our net income (loss) for the period of $(106.4) million and changes in operating assets and liabilities of $2.4 million, partially offset by non-cash items totaling $12.2 million. Non-cash items included $5.8 million related to stock-based compensation expense, $5.4 million related to the change in fair value of the derivative liability and $1.5 million related to depreciation and amortization, partially offset by net accretion of discounts on marketable securities of $0.5 million. The changes in operating assets and liabilities primarily include an increase of $10.5 million in research and development prepaid expenses, a decrease of $1.9 million in other accrued expenses and current liabilities, and a decrease of $1.0 million in operating lease liabilities, partially offset by an increase of $7.8 million in accounts payable and an increase of $3.6 million in research and development accrued expenses.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2024 was due to our net loss for the period of $199.5 million partially offset by changes in non-cash items totaling $18.9 million and operating assets and liabilities of $0.3 million. Non-cash items included $13.1 million related to stock-based compensation expense, $5.4 million related to the change in fair value of the derivative liability and $2.3 million related to depreciation and amortization, partially offset by net accretion of discounts on marketable securities of $2.0 million. The changes in operating assets and liabilities primarily included an increase of $7.2 million in research and development accrued expenses, an increase of $5.3 million in accounts payable and a $0.4 million increase in other accrued expenses and current liabilities, partially offset by an
Previous wording
Net cash provided by investing activities for the six months ended June 30, 2025 of $168.8 million was related to proceeds from maturities of marketable securities of $144.3 million and cash, cash equivalents and restricted cash acquired in connection with the ACELYRIN Merger of $49.7 million, partially offset by purchases of marketable securities of $24.5 million and purchases of property and equipment of $0.7 million.
Current wording
Net cash provided by investing activities for the nine months ended September 30, 2025 of $192.9 million was related to proceeds from maturities of marketable securities of $305.4 million and cash, cash equivalents and restricted cash acquired in connection with the ACELYRIN Merger of $49.7 million, partially offset by purchases of marketable securities of $161.6 million and purchases of property and equipment of $0.7 million.
Showing the first 40 of 56 pairs. Open the source sections for the rest.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
Milestones related to previously acquired IPR&D assets for the three months ended September 30, 2024, included a $23.0 million clinical milestone payment made in connection with a stock purchase agreement to acquire FronThera U.S. Holdings, Inc. and its wholly owned subsidiary, FronThera U.S. Pharmaceuticals LLC, in March 2021 (the “FronThera Acquisition”).
Current report — wording carried from elsewhere
Our primary uses of cash are to fund our operations, which consist primarily of research and development expenditures related to our programs and, to a lesser extent, general and administrative expenditures. We anticipate that we will continue to incur significant and increasing expenses for the foreseeable future as we continue to advance our product candidates,
Current report — wording carried from elsewhere
increase of $9.6 million in research and development prepaid expenses, an increase of $1.6 million in other prepaid expenses and other assets and a decrease of $1.5 million in operating lease liabilities.
Current report — wording carried from elsewhere
Upon the closing of the Merger Agreement, we became the successor to ACELYRIN’s rights and obligations under the Pierre Fabre Agreement. We received certain exclusive worldwide licenses with the right to sublicense certain patents, know-how and other intellectual property to develop, manufacture, use and commercialize lonigutamab for non-oncology
Current report — wording carried from elsewhere
events differ materially from the estimates and assumptions used by us in applying these policies, our reported financial condition and results of operations could be materially affected. Significant changes to our critical accounting policies from those described in the Annual Report on Form 10-K are described below.
Current report — wording carried from elsewhere
determine the transaction price, (iv) allocate the transaction price to the performance obligations, and (v) recognize revenue when (or as) the customer obtains control of the product or service.
Rearranged previous paragraphs (6)
Previous report — wording carried elsewhere
Gain on bargain purchase was $187.9 million for the three and six months ended June 30, 2025 as compared to zero for the three and six months ended June 30, 2024, and represents the excess of fair value of net assets acquired in the ACELYRIN Merger over the purchase consideration on the Closing Date.
Previous report — wording carried elsewhere
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. If we are unable to raise capital as and when needed, or on attractive terms, we may have to significantly delay, reduce, or discontinue the development and commercialization of our product candidates or scale back or terminate our pursuit of new in-licenses and acquisitions.
Previous report — wording carried elsewhere
institutes a patent challenge against the licensed patents from Pierre Fabre. We may also terminate the Pierre Fabre Agreement with or without cause upon nine months’ prior written notice, so long as there is no ongoing clinical trial for any PF Licensed Product.
Previous report — wording carried elsewhere
frequently if events or changes in circumstances indicate that it is more likely than not that the assets are impaired. Development costs incurred after an acquisition are expensed as incurred
Previous report — wording carried elsewhere
We then allocate the transaction price to each distinct performance obligation based on the relative standalone selling price. Key assumptions to determine the standalone selling price may include forecasted revenues, development timelines,
Previous report — wording carried elsewhere
Subject to certain conditions, as an emerging growth company, we may rely on certain of these exemptions, including without limitation exemptions to the requirements for (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier