Maze Therapeutics, Inc.
For the period ended Sep 30, 2025. Filed Nov 6, 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 6, 2025
MAZE$34.19+5.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0000950170-25-107306
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001193125-25-269689
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 114 previous paragraphs and 121 current paragraphs.
90 unchanged; 19 reworded; 12 added; 5 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 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 (12)
Current report
MZE782 Phase 1 Trial Results
Current report
On September 11, 2025, we announced positive clinical results from the Phase 1 healthy volunteer study of MZE782. The Phase 1 trial of MZE782 was a randomized, double-blind, placebo-controlled study evaluating single ascending doses and multiple ascending doses of orally administered MZE782 in 112 healthy adult volunteers. The single ascending doses, or SAD, ranged from 30 mg to 960 mg and the multiple ascending doses, or MAD, with dosing once or twice daily for seven days, ranged from 120 mg to 240 mg twice daily and 120 mg to 720 mg once daily. The primary objective was to evaluate the safety and tolerability of single and multiple ascending oral doses of MZE782 in healthy volunteers. Secondary and exploratory endpoints included pharmacokinetics, food effect, pharmacodynamic measures of target engagement, specifically urinary excretion of phenylalanine, or Phe, and glutamine, or Gln, as predictive biomarkers of SLC6A19 inhibition and disease control, and estimated glomerular filtration rate, or eGFR.
Current report
MZE782 was well tolerated across all doses in all cohorts. There were no serious adverse events, no severe adverse events and no treatment-related adverse events, or TRAEs, leading to discontinuation. In the single ascending dose portion of the study (n=56), there were a total of three TRAEs reported that were all mild in severity and not seen at the higher doses. Headache was reported in two patients (4%) and diarrhea was reported in one patient (2%). There were no TRAEs reported in the MAD portion of the study. No clinically relevant changes in vital signs, laboratory tests or electrocardiograms were observed.
Current report
MZE782 demonstrated a favorable plasma pharmacokinetics profile after single and multiple oral doses. Oral administration was associated with consistent absorption, with a time to maximum concentration (tmax) of six hours and a half-life (t1/2) of 11 hours. Exposure increased proportionally with dose, and steady-state was achieved by Day 3. This is supportive of a once- or twice-daily dosing regimen to be evaluated in Phase 2.
Current report
MZE782 produced dose-dependent increases in 24-hour urinary excretion of the neutral amino acids Phe and Gln across both SAD and MAD cohorts, confirming target engagement and SLC6A19 inhibition. All participants in the MAD cohorts of the Phase 1 study were assessed for changes in eGFR. MZE782 demonstrated a dose-dependent initial eGFR dip over seven days of dosing that was similar in magnitude to what has been observed in patients initiating SGLT2 and RAAS inhibitors.
Current report
We plan to initiate two Phase 2 proof-of-concept trials of MZE782, evaluating plasma Phe reduction in phenylketonuria, or PKU, and proteinuria reduction in chronic kidney disease, or CKD, in 2026.
Current report
Income tax benefit (expense)
Current report
Comparisons of the three and nine months ended September 30, 2025 and 2024
Current report
Income tax benefit (expense)
Current report
In September 2025, we completed the Private Placement, pursuant to which we issued and sold an aggregate of 4,000,002 shares of our common stock at a purchase price of $16.25 per share and Pre-Funded Warrants to purchase up to an aggregate of 5,231,090 shares of our common stock at a purchase price of $16.249 per Pre-Funded Warrant, resulting in net proceeds of approximately $141.3 million, after deducting placement fees and other offering expenses payable by the Company of approximately $8.7 million. The Pre-Funded Warrants have an exercise price of $0.001 per share, are immediately exercisable and do not expire. As of September 30, 2025, none of the Pre-Funded Warrants have been exercised.
Current report
Comparisons of the nine months ended September 30, 2025 and 2024
Current report
Net cash used in investing activities was $67.6 million for the nine months ended September 30, 2025, which related to purchases of marketable securities of $66.8 million and purchases of property and equipment of $0.8 million. Net cash used in investing activities was $0.5 million for the nine months ended September 30, 2024, which related to purchases of property and equipment.
Removed paragraphs (5)
Previous report
Income tax expense
Previous report
Comparisons of the three and six months ended June 30, 2025 and 2024
Previous report
Income tax expense
Previous report
Comparisons of the six months ended June 30, 2025 and 2024
Previous report
Net cash used in investing activities was $0.7 million and $0.4 million for the six months ended June 30, 2025 and 2024, respectively, which related to the purchase of property and equipment.
Reworded paragraphs (19)
Previous wording
We have incurred significant losses and negative cash flows from operations since our inception, except for the net income and cash provided by operations due to license revenue recognized during the year ended December 31, 2024, and we expect to incur significant and increasing losses as a result of our continued research and development activities. During the three and six months ended June 30, 2025, we incurred net losses of $33.7 million and $66.5 million, respectively. During the three and six months ended June 30, 2024, we incurred net income of $139.1 million and $106.6 million, respectively. As of June 30, 2025, we had an accumulated deficit of $424.9 million and do not expect positive cash flows from operations in the foreseeable future. We expect to continue incurring significant expenses and increasing losses for the foreseeable future. Our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities, as well as upon revenue from our license agreements. We expect our research and development expenses to significantly increase in connection with the conduct of planned clinical trials for our lead programs, MZE829 and MZE782, further development of our Compass platform, planned preclinical studies, and potential Investigational New Drug Applications, or INDs, and clinical trials for future therapeutic candidates. We will also incur substantial additional expenses as we seek to expand our intellectual property portfolio, including through potential in-licensing opportunities, and hire additional personnel as we scale up our operations. In addition, we expect to incur additional costs associated with operating as a public company.
Current wording
We have incurred significant losses and negative cash flows from operations since our inception, except for the net income and cash provided by operations due to license revenue recognized during the year ended December 31, 2024, and we expect to incur significant and increasing losses as a result of our continued research and development activities. During the three and nine months ended September 30, 2025, we incurred a net loss of $30.1 million and $96.6 million, respectively. During the three and nine months ended September 30, 2024, we incurred a net loss of $24.8 million and net income of $81.8 million, respectively. As of September 30, 2025, we had an accumulated deficit of $455.0 million and do not expect positive cash flows from operations in the foreseeable future. We expect to continue incurring significant expenses and increasing losses for the foreseeable future. Our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities, as well as upon revenue from our license agreements. We expect our research and development expenses to significantly increase in connection with the conduct of planned clinical trials for our lead programs, MZE829 and MZE782, further development of our Compass platform, planned preclinical studies, and potential Investigational New Drug Applications, or INDs, and clinical trials for future therapeutic candidates. We will also incur substantial additional expenses as we seek to expand our intellectual property portfolio, including through potential in-licensing opportunities, and hire additional personnel as we scale up our operations. In addition, we expect to incur additional costs associated with operating as a public company.
Previous wording
As of June 30, 2025, we had cash and cash equivalents of $264.5 million. Since our inception, we have financed our operations primarily through issuances of our equity, license agreements with biotechnology companies and issuances of convertible promissory notes. In February 2025, we completed our initial public offering, pursuant to which we issued and sold an aggregate of 8,750,000 shares of our common stock at an initial public offering price of $16.00 per share, resulting in gross proceeds of $140.0 million.
Current wording
As of September 30, 2025, we had cash, cash equivalents and marketable securities of $383.9 million. Since our inception, we have financed our operations primarily through issuances of our equity, license agreements with biotechnology companies and issuances of convertible promissory notes. In February 2025, we completed our initial public offering, pursuant to which we issued and sold an aggregate of 8,750,000 shares of our common stock at an initial public offering price of $16.00 per share, resulting in gross proceeds of $140.0 million. In September 2025, we entered into a securities purchase agreement, or the Private Placement, with certain investors, pursuant to which we issued and sold an aggregate of 4,000,002 shares of our common stock at a purchase price of $16.25 per share and pre-funded warrants, or the Pre-Funded Warrants, to purchase up to an aggregate of 5,231,090 shares of our common stock at a purchase price of $16.249 per Pre-Funded Warrant, resulting in gross proceeds of $150.0 million. The Pre-Funded Warrants have an exercise price of $0.001 per share, are immediately exercisable and do not expire.
Previous wording
In March 2024, we entered into an exclusive license agreement, or the License Agreement, with Shionogi, pursuant to which we granted Shionogi an exclusive, worldwide, sublicensable license to research, develop, manufacture and commercialize MZE001 and certain other small molecule compounds modulating glycogen synthase 1, or the Licensed Products. As consideration for the licensed rights and the transfer of know-how and materials, we received an upfront payment of $150 million, which is the only payment we have received under the License Agreement to date. The License Agreement also requires that Shionogi pay us up to $275 million in the aggregate in milestone payments upon the completion of certain clinical and regulatory milestones and up to $330 million in the aggregate in milestone payments if certain sales milestones are achieved. The License Agreement also requires that Shionogi pay us tiered royalties ranging from percentages in the low double-digits to twenty on net sales of Licensed Products, subject to certain deductions.
Current wording
In March 2024, we entered into an exclusive license agreement, or the License Agreement, with Shionogi, pursuant to which we granted Shionogi an exclusive, worldwide, sublicensable license to research, develop, manufacture and commercialize MZE001 and certain other small molecule compounds modulating glycogen synthase 1, or the Licensed Products. As consideration for the licensed rights and the transfer of know-how and materials, we received an upfront payment of $150.0 million, which is the only payment we have received under the License Agreement to date. The License Agreement also requires that Shionogi pay us up to $275.0 million in the aggregate in milestone payments upon the completion of certain clinical and regulatory milestones and up to $330.0 million in the aggregate in milestone payments if certain sales milestones are achieved. The License Agreement also requires that Shionogi pay us tiered royalties ranging from percentages in the low double-digits to twenty on net sales of Licensed Products, subject to certain deductions.
Previous wording
Interest and other income, net consists of interest income earned on our cash and cash equivalents, interest expense, foreign currency re-measurement and transaction gains and losses. We expect interest income to increase as a result of the receipt of net proceeds of approximately $127.8 million from our initial public offering completed in February 2025. However, interest income may vary each reporting period depending on our average cash deposits, money market fund balances and other investment balances during the period and prevailing market interest rates. We expect foreign currency gains and losses to vary each reporting period depending on the fluctuations in foreign currency exchange rates.
Current wording
Interest and other income, net consists of interest income earned on our cash, cash equivalents and marketable securities, interest expense, foreign currency re-measurement and transaction gains and losses. We expect interest income to increase as a result of the receipt of net proceeds of approximately $127.8 million from our initial public offering completed in February 2025 and net proceeds of approximately $141.3 million from our Private Placement completed in September 2025. However, interest income may vary each reporting period depending on our average cash deposits, money market fund balances and other investment balances during the period and prevailing market interest rates. We expect foreign currency gains and losses to vary each reporting period depending on the fluctuations in foreign currency exchange rates.
Previous wording
From December 2023 through April 2024, we issued a total of $40.7 million aggregate principal amount of convertible promissory notes, which contained automatic conversion features triggered upon a qualified preferred stock financing or a qualified public offering. We elected to apply the fair value option, as per Accounting Standards Codification, or ASC, Section 825-10, to the outstanding convertible promissory notes issued. As such, the convertible promissory notes were recognized at fair value with changes in fair value recognized in the condensed statements of operations and comprehensive (loss) income. We recorded a net gain of $0.2 million and a net loss of $4.5 million in the condensed statements of operations and comprehensive (loss) income for the three and six months ended June 30, 2024, respectively, reflecting the change in the fair value of the convertible promissory notes. The impact of interest expense on the convertible promissory notes is included within the changes in fair value. In connection with the private placement of our Series D convertible preferred stock, or Series D Preferred Stock, in November 2024, which was a qualified preferred stock financing pursuant to the terms of the convertible promissory notes, the outstanding convertible promissory notes automatically converted into 39,395,572 shares of Series D-1 convertible preferred stock, or Series D-1 Preferred Stock, at a conversion price of $1.10336 per share. No convertible promissory notes were outstanding as of December 31, 2024. Accordingly, no change in fair value of convertible promissory notes was recorded in the condensed statements of operations and comprehensive (loss) income for the three and six months ended June 30, 2025.
Current wording
From December 2023 through April 2024, we issued a total of $40.7 million aggregate principal amount of convertible promissory notes, which contained automatic conversion features triggered upon a qualified preferred stock financing or a qualified public offering. We elected to apply the fair value option, as per Accounting Standards Codification, or ASC, Section 825-10, to the outstanding convertible promissory notes issued. As such, the convertible promissory notes were recognized at fair value with changes in fair value recognized in the condensed statements of operations and comprehensive (loss) income. We recorded a net loss of $2.6 million and $7.2 million in the condensed statements of operations and comprehensive (loss) income for the three and nine months ended September 30, 2024, respectively, reflecting the change in the fair value of the convertible promissory notes. The impact of interest expense on the convertible promissory notes is included within the changes in fair value. In connection with the private placement of our Series D convertible preferred stock, or Series D Preferred Stock, in November 2024, which was a qualified preferred stock financing pursuant to the terms of the convertible promissory notes, the outstanding convertible promissory notes automatically converted into 39,395,572 shares of Series D-1 convertible preferred stock, or Series D-1 Preferred Stock, at a conversion price of $1.10336 per share. No convertible promissory notes were outstanding as of December 31, 2024. Accordingly, no change in fair value of convertible promissory notes was recorded in the condensed statements of operations and comprehensive (loss) income for the three and nine months ended September 30, 2025.
Previous wording
We recognized no license revenue for the three and six months ended June 30, 2025. We recognized a total of $165.0 million of license revenue for the three and six months ended June 30, 2024. License revenue recognized in 2024 primarily related to the License Agreement with Shionogi, wherein we received an upfront payment of $150.0 million in exchange for the transfer of the license, know-how, and materials related to the research, development, manufacture and commercialization of MZE001 and certain other small molecule compounds modulating glycogen synthase 1. License revenue recognized in 2024 also included amounts related to the exclusive license agreement with Trace Neuroscience, Inc., or Trace, wherein we received an upfront payment of $15.0 million in exchange for the transfer of the license, know-how, and materials related to the research, development, manufacture and commercialization of a discovery research program targeting UNC13A for the treatment of amyotrophic lateral sclerosis, or ALS.
Current wording
We recognized no license revenue for the three and nine months ended September 30, 2025. We recognized $2.5 million and $167.5 million of license revenue for the three and nine months ended September 30, 2024, respectively. License revenue recognized in 2024 primarily related to the License Agreement with Shionogi, wherein we received an upfront payment of $150.0 million in exchange for the transfer of the license, know-how, and materials related to the research, development, manufacture and commercialization of MZE001 and certain other small molecule compounds modulating glycogen synthase 1. License revenue recognized in 2024 also included amounts related to the exclusive license agreement with Trace Neuroscience, Inc., or Trace, wherein we received an upfront payment of $15.0 million in exchange for the transfer of the license, know-how, and materials related to the research, development, manufacture and commercialization of a discovery research program targeting UNC13A for the treatment of amyotrophic lateral sclerosis, or ALS, and $2.5 million related to the exclusive license agreement with Neurocrine Biosciences, Inc., or Neurocrine, for the transfer of the license, know-how and materials related to a discovery research program targeting ATXN2.
Previous wording
Research and development expenses were $28.1 million and $19.5 million for the three months ended June 30, 2025 and 2024, respectively. The increase of $8.6 million between the comparative three month periods was primarily due to an increase of $2.7 million in clinical trial expenses and $1.6 million in manufacturing expenses based on the progression of our Phase 2 clinical trial for MZE829 that was initiated in November 2024 and our Phase 1 clinical trial for MZE782 that was initiated in September 2024. The increase also reflects higher personnel-related costs of $2.4 million due to an increase in headcount and higher costs for outside research and development services of $1.2 million for our early research programs.
Current wording
Research and development expenses were $25.2 million and $19.9 million for the three months ended September 30, 2025 and 2024, respectively. The increase of $5.3 million between the comparative three month periods was primarily due to an increase of $3.1 million in personnel-related costs due to an increase in headcount, an increase of $1.9 million in clinical trial expenses based on the progression of our Phase 2 clinical trial for MZE829 that was initiated in November 2024. The increase also reflects higher costs for outside research and development services of $0.3 million to support our research programs.
Previous wording
Research and development expenses were $55.7 million and $41.4 million for the six months ended June 30, 2025 and 2024, respectively. The increase of $14.3 million between the comparative six month periods was primarily due to an increase of $5.8 million in clinical trial expenses and $1.5 million in manufacturing expenses based on the progression of our Phase 2 clinical trial for MZE829 and our Phase 1 clinical trial for MZE782. The increase also reflects higher personnel-related costs of $4.2 million due to an increase in headcount and higher costs for outside research and development services of $1.9 million for our early research programs.
Current wording
Research and development expenses were $80.9 million and $61.3 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $19.6 million between the comparative nine month periods was primarily due to an increase of $7.8 million in clinical trial expenses and an increase of $1.7 million in manufacturing expenses based on the progression of our Phase 2 clinical trial for MZE829 and our Phase 1 clinical trial for MZE782. The increase also reflects higher personnel-related costs of $7.3 million due to an increase in headcount and higher costs for outside research and development services of $2.1 million to support our research programs.
Previous wording
General and administrative expenses were $8.4 million and $5.9 million for the three months ended June 30, 2025 and 2024, respectively. The increase of $2.5 million between the comparative three month periods was primarily due to an increase of $1.2 million in personnel-related costs due to an increase in headcount and higher costs for professional service fees of $0.8 million.
Current wording
General and administrative expenses were $7.8 million and $6.9 million for the three months ended September 30, 2025 and 2024, respectively. The increase of $0.9 million between the comparative three month periods was primarily due to an increase of $0.7 million in personnel-related costs due to an increase in headcount and higher facilities and other costs of $0.3 million.
Previous wording
General and administrative expenses were $16.2 million and $12.0 million for the six months ended June 30, 2025 and 2024, respectively. The increase of $4.2 million between the comparative six month periods was primarily due to an increase of $2.6 million in personnel-related costs due to an increase in headcount and higher costs for professional service fees of $0.6 million.
Current wording
General and administrative expenses were $24.0 million and $18.9 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $5.1 million between the comparative nine month periods was primarily due to an increase of $3.1 million in personnel-related costs due to an increase in headcount, higher facilities and other costs of $1.0 million, and higher costs for professional service fees of $0.7 million.
Previous wording
Interest and other income, net was $2.8 million and $5.4 million for the three and six months ended June 30, 2025, respectively. Interest and other income, net was $1.0 million and $1.3 million for the three and six months ended June 30, 2024, respectively. The increase of $1.8 million and $4.1 million between the comparative three and six months periods, respectively, primarily reflects an increase in interest income as a result of higher cash and cash equivalent balances held during the three and six months ended June 30, 2025 from the proceeds received from the private placement of our Series D Preferred Stock completed in November 2024 and initial public offering completed in February 2025.
Current wording
Interest and other income, net was $2.9 million and $8.3 million for the three and nine months ended September 30, 2025, respectively. Interest and other income, net was $1.8 million and $3.1 million for the three and nine months ended September 30, 2024, respectively. The increase of $1.0 million and $5.2 million between the comparative three and nine months periods, respectively, primarily reflects an increase in interest income as a result of higher cash, cash equivalent, and marketable securities balances held during the three and nine months ended September 30, 2025 from the proceeds received from the private placement of our Series D Preferred Stock completed in November 2024, the initial public offering completed in February 2025 and the Private Placement completed in September 2025.
Previous wording
The convertible promissory notes issued from December 2023 through April 2024 contained automatic conversion features that triggered upon a qualified preferred stock financing or a qualified public offering. We elected to apply the fair value option to the convertible promissory notes issued. As such, the convertible promissory notes were recorded at fair value at each reporting period with changes in fair value recognized in the condensed statements of operations and comprehensive (loss) income. The change in fair value of the convertible promissory notes resulted in a net gain of $0.2 million and a net loss of $4.5 million for the three and six months ended June 30, 2024. The convertible promissory notes converted into Series D-1 Preferred Stock in November 2024 in connection with the private placement of our Series D Preferred Stock, which was a qualified preferred stock financing pursuant to the terms of the convertible promissory notes. No convertible promissory notes were outstanding as of December 31, 2024. Accordingly, no change in fair value of convertible promissory notes was recorded in the condensed statements of operations and comprehensive (loss) income for the three and six months ended June 30, 2025.
Current wording
The convertible promissory notes issued from December 2023 through April 2024 contained automatic conversion features that triggered upon a qualified preferred stock financing or a qualified public offering. We elected to apply the fair value option to the convertible promissory notes issued. As such, the convertible promissory notes were recorded at fair value at each reporting period with changes in fair value recognized in the condensed statements of operations and comprehensive (loss) income. The change in fair value of the convertible promissory notes resulted in a net loss of $2.6 million and $7.2 million for the three and nine months ended September 30, 2024, respectively. The convertible promissory notes converted into Series D-1 Preferred Stock in November 2024 in connection with the private placement of our Series D Preferred Stock, which was a qualified preferred stock financing pursuant to the terms of the convertible promissory notes. No convertible promissory notes were outstanding as of December 31, 2024. Accordingly, no change in fair value of convertible promissory notes was recorded in the condensed statements of operations and comprehensive (loss) income for the three and nine months ended September 30, 2025.
Previous wording
Income tax expense was zero for the three and six months ended June 30, 2025 compared to $1.7 million for the three and six months ended June 30, 2024. The decrease between the comparative three and six months periods was due to the net income generated during the three and six months ended June 30, 2024, as a result of the recognition of license revenue under our license agreements with Shionogi and Trace, as compared to the net loss incurred during the three and six months ended June 30, 2025.
Current wording
Income tax benefit (expense) was zero for the three and nine months ended September 30, 2025 compared to an income tax benefit of $0.3 million and an income tax expense of $1.4 million for the three and nine months ended September 30, 2024, respectively. The amounts recognized in the comparative periods in 2024 were primarily due to the net income generated as a result of the recognition of license revenue under our license agreement with Shionogi, resulting in taxable income to the Company, as compared to the net loss incurred during the three and nine months ended September 30, 2025.
Previous wording
Since our inception, we have not generated any revenue from product sales and we do not expect to generate any revenue from commercial sales for the foreseeable future, if at all. We have incurred significant operating losses and negative cash flows from operations. We anticipate that we will continue to incur net losses for the foreseeable future. To date, we have financed our operations primarily through private placements of redeemable convertible preferred stock, one-time, nonrefundable upfront payments made to us in connection with our entry into license agreements, private placements of convertible promissory notes, and most recently, through an initial public offering of our common stock. As of June 30, 2025, we had cash and cash equivalents of $264.5 million and an accumulated deficit of $424.9 million.
Current wording
Since our inception, we have not generated any revenue from product sales and we do not expect to generate any revenue from commercial sales for the foreseeable future, if at all. We have incurred significant operating losses and negative cash flows from operations. We anticipate that we will continue to incur net losses for the foreseeable future. To date, we have financed our operations primarily through private placements of redeemable convertible preferred stock, one-time, nonrefundable upfront payments made to us in connection with our entry into license agreements, private placements of convertible promissory notes, and most recently, through an initial public offering of our common stock. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $383.9 million and an accumulated deficit of $455.0 million.
Previous wording
Based on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to fund our operations for at least one year from the date of this Quarterly Report on Form 10-Q. We have based this estimate on our current assumptions, which may prove to be wrong, and we may exhaust our available capital resources sooner than we expect.
Current wording
Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations for at least one year from the date of this Quarterly Report on Form 10-Q. We have based this estimate on our current assumptions, which may prove to be wrong, and we may exhaust our available capital resources sooner than we expect.
Previous wording
We have entered into consortium agreements with the University of Helsinki and Queen Mary University to access genomic information from patient samples and genetic and paired clinical data. As of June 30, 2025, we are obligated to pay $4.9 million under these agreements through the year ended December 31, 2027.
Current wording
We have entered into consortium agreements with the University of Helsinki and Queen Mary University to access genomic information from patient samples and genetic and paired clinical data. As of September 30, 2025, we are obligated to pay $4.6 million under these agreements through the year ended December 31, 2027.
Previous wording
Net cash used in operating activities was $59.6 million for the six months ended June 30, 2025 and net cash provided by operating activities was $121.6 million for the six months ended June 30, 2024. The net cash used in operating activities for the six months ended June 30, 2025 was primarily due to our net loss of $66.5 million combined with a net change in our operating assets and liabilities of $2.5 million, offset by $9.4 million in non-cash charges such as depreciation, stock-based compensation and lease expense. The net cash provided by operating activities for the six months ended June 30, 2024 was primarily due to our net income of $106.6 million combined with a net change in our operating assets and liabilities of $2.7 million and $12.4 million in non-cash charges such as depreciation, stock-based compensation, lease expense and the change in fair value of the convertible promissory notes.
Current wording
Net cash used in operating activities was $84.2 million for the nine months ended September 30, 2025 and net cash provided by operating activities was $98.4 million for the nine months ended September 30, 2024. The net cash used in operating activities for the nine months ended September 30, 2025 was primarily due to our net loss of $96.6 million combined with a net change in our operating assets and liabilities of $2.0 million, offset by $14.3 million in non-cash charges such as depreciation, stock-based compensation, lease expense and accretion of discounts on marketable securities. The net cash provided by operating activities for the nine months ended September 30, 2024 was primarily due to our net income of $81.8 million, combined with $19.2 million in non-cash charges such as depreciation, stock-based compensation, lease expense and the change in fair value of the convertible promissory notes, offset by a net change in our operating assets and liabilities of $2.6 million.
Previous wording
For the six months ended June 30, 2025, net cash provided by financing activities was $128.0 million, which consisted of net proceeds of $127.8 million from the issuance of common stock pursuant to our initial public offering, $0.6 million from the issuance of common stock under the 2025 Employee Stock Purchase Plan and $0.1 million from the exercise of stock option awards, net of repurchases, partially offset by the payment of $0.5 million for the success fee under the loan and security agreement. For the six months ended June 30, 2024, net cash provided by financing activities was $24.7 million, which consisted of net proceeds from the issuance of convertible promissory notes of $24.5 million and $0.4 million from the exercise of stock option awards, net of repurchases, partially offset by the payment of $0.2 million for deferred offering costs related to our initial public offering.
Current wording
For the nine months ended September 30, 2025, net cash provided by financing activities was $271.7 million, which consisted of net proceeds of $127.8 million from the issuance of common stock pursuant to our initial public offering, $141.7 million of net proceeds from the issuance of common stock and Pre-Funded Warrants in the Private Placement, $2.1 million from the exercise of stock option awards, net of repurchases and $0.6 million from the issuance of common stock under the 2025 Employee Stock Purchase Plan, partially offset by the payment of $0.5 million for the success fee under the loan and security agreement. For the nine months ended September 30, 2024, net cash provided by financing activities was $22.6 million, which consisted of net proceeds from the issuance of convertible promissory notes of $24.5 million and $0.7 million from the exercise of stock option awards, net of repurchases, partially offset by the payment of $2.6 million for deferred offering costs.
Previous wording
Our significant accounting policies are described in detail in the notes to our condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q. We described the accounting policies that we believe involve a significant level of estimation and uncertainty, which could have a material impact on our financial condition or results of operations and are therefore deemed critical accounting policies, in our “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March, 31, 2025. There have been no significant changes in our critical accounting policies and estimates during the six months ended June 30, 2025.
Current wording
Our significant accounting policies are described in detail in the notes to our condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q. We described the accounting policies that we believe involve a significant level of estimation and uncertainty, which could have a material impact on our financial condition or results of operations and are therefore deemed critical accounting policies, in our “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March, 31, 2025. There have been no significant changes in our critical accounting policies and estimates during the nine months ended September 30, 2025.