Maze Therapeutics, Inc.

Previous wording

We are a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic, or CVRM diseases, including obesity. We are advancing a pipeline using our Compass platform, which allows us to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process we refer to as variant functionalization. Our Compass platform has been purpose-built to inform all phases of our drug discovery and development process through clinical trial design. We are currently advancing two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach. Our goal is to bring novel precision medicines to patients with CVRM diseases, which is where we believe we can maximize our impact on human health.

Current wording

We are a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with kidney and metabolic diseases, including obesity. We are advancing a pipeline using our Compass platform, which allows us to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process we refer to as variant functionalization. Our Compass platform has been purpose-built to inform all phases of our drug discovery and development process through clinical trial design. We are currently advancing two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach. Our goal is to bring novel precision medicines to patients with kidney and metabolic diseases, which is where we believe we can maximize our impact on human health.

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 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 months ended March 31, 2025 and 2024, we incurred net losses of $32.8 million and $32.5 million, respectively. As of March 31, 2025, we had an accumulated deficit of $391.2 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 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.

Previous wording

As of March 31, 2025, we had cash and cash equivalents of $294.4 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 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.

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. We recorded a loss of $4.8 million, reflecting the change in the fair value of the convertible promissory notes in the condensed statements of operations and comprehensive loss for the three months ended March 31, 2024. 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 for the three months ended March 31, 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 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.

Previous wording

Comparisons of the three months ended March 31, 2025 and 2024

Current wording

Comparisons of the three and six months ended June 30, 2025 and 2024

Previous wording

Research and development expenses were $27.6 million and $21.9 million for the three months ended March 31, 2025 and 2024, respectively. The increase of $5.7 million between the comparative periods was primarily due to an increase of $3.1 million in clinical trial 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 $1.7 million due to an increase in headcount and higher outside research and development services of $0.6 million primarily related to professional service fees for our research programs.

Current 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.

Previous wording

General and administrative expenses were $7.8 million and $6.1 million for the three months ended March 31, 2025 and 2024, respectively. The increase of $1.7 million between the comparative periods was primarily due to an increase of $1.4 million in personnel-related costs due to an increase in headcount and higher professional service fees of $0.3 million.

Current 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.

Previous wording

Interest and other income, net was $2.6 million and $0.3 million for the three months ended March 31, 2025 and 2024, respectively. The increase of $2.3 million between the comparative periods primarily reflects an increase in interest income as a result of higher cash and cash equivalent balances held during the three months ended March 31, 2025 from the nonrefundable upfront payments that we received pursuant to the license agreements we entered with Shionogi, Trace and Neurocrine in 2024, and proceeds 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 $2.8 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.

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. The change in fair value of the convertible promissory notes resulted in a loss of $4.8 million for the three months ended March 31, 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 for the three months ended March 31, 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 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.

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 March 31, 2025, we had cash and cash equivalents of $294.4 million and an accumulated deficit of $391.2 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 June 30, 2025, we had cash and cash equivalents of $264.5 million and an accumulated deficit of $424.9 million.

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 March 31, 2025, we are obligated to pay $5.0 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 June 30, 2025, we are obligated to pay $4.9 million under these agreements through the year ended December 31, 2027.

Previous wording

Net cash used in operating activities was $29.5 million and $23.4 million for the three months ended March 31, 2025 and 2024, respectively. The net cash used in operating activities for the three months ended March 31, 2025 was primarily due to our net loss of $32.8 million combined with a net change in our operating assets and liabilities of $1.4 million, offset by $4.7 million in non-cash charges such as depreciation, stock-based compensation and lease expense. The net cash used in operating activities for the three months ended March 31, 2024 was primarily due to our net loss of $32.5 million, offset by a net change in our operating assets and liabilities of $0.3 million as well as $8.8 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 $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.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2025 and 2024 was $0.3 million in each period, which related to the purchase of property and equipment.

Current wording

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.

Previous wording

For the three months ended March 31, 2025, net cash provided by financing activities was $127.4 million, which consisted of net proceeds of $127.8 million from the issuance of common stock pursuant to the initial public offering and $0.1 million from the exercise of stock option awards, net of repurchases, offset by the payment of $0.5 million for the success fee under the loan and security agreement.

Current 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.

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 three months ended March 31, 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 six months ended June 30, 2025.