Company Overview - Maze Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule precision medicines for patients with renal, metabolic, and cardiovascular diseases [3] - The company utilizes its Compass platform to gain insights into genetic variants associated with diseases and their biological pathways [3] Upcoming Event - Jason Coloma, Ph.D., CEO of Maze Therapeutics, will present a company overview and engage in one-on-one meetings at the 3rd Annual H.C. Wainwright BioConnect Investor Conference on May 20, 2025 [1][2] - The presentation is scheduled for 11 a.m. ET and will be accessible on the company's website, with a replay available for 60 days [2] Pipeline and Programs - Maze Therapeutics is advancing a pipeline led by two wholly owned programs, MZE829 and MZE782, which represent novel precision medicine approaches for patients [3]

Financial Performance - The company incurred a net loss of $100.4 million for the year ended December 31, 2023, and had an accumulated deficit of $358.4 million as of December 31, 2024[243]. - The company anticipates continued operating losses due to the high costs associated with clinical trials, preclinical studies, and regulatory approval processes[243]. - The company has incurred substantial losses and does not expect to become profitable in the near future, with limitations on the deductibility of federal net operating losses (NOLs) to 80% of current year taxable income starting from taxable years after December 31, 2020[429]. Cash and Funding - As of December 31, 2024, the company had cash and cash equivalents of $196.8 million, which, along with net proceeds of approximately $127.8 million from its initial public offering, is expected to fund operations for at least one year[252]. - The company may require additional capital to finance its operations and achieve its goals, with potential dilution to existing shareholders if capital is raised through equity offerings[250][255]. - The company’s future capital requirements will depend on various factors, including the costs of clinical trials, regulatory approvals, and potential partnerships[253]. Research and Development - The company expects significant increases in research and development expenses related to clinical trials for lead programs MZE829 and MZE782, as well as the expansion of its Compass platform[245]. - The company initiated a Phase 2 trial of MZE829 in November 2024 and expects to report proof of concept data in the first quarter of 2026[262]. - A Phase 1 clinical trial of MZE782 was initiated in September 2024[266]. Clinical Trials and Regulatory Challenges - The company faces high risks of failure in its early-stage programs, with potential therapeutic candidates needing to demonstrate safety and efficacy in extensive clinical trials before obtaining marketing approval[267]. - Delays in clinical trials can arise from regulatory approval issues, patient enrollment challenges, and external factors such as natural disasters or public health crises[268]. - The company must navigate various regulatory requirements and potential delays in obtaining necessary approvals for clinical trials[274]. Competition and Market Dynamics - The company faces significant competition in the biotechnology industry, with competitors potentially achieving regulatory approval before it does[382]. - There are currently no approved therapies for APOL1 kidney disease, but other companies are advancing therapeutic candidates in clinical trials targeting APOL1[385]. - The company may face challenges in obtaining adequate reimbursement for drugs, as coverage policies vary significantly among third-party payors in the U.S.[360]. Intellectual Property and Legal Risks - The company's success depends on obtaining and maintaining intellectual property rights, with challenges in protecting technologies and potential competition from similar products[432]. - The patenting process is costly and time-consuming, and the company may not be able to file all necessary patent applications in a timely manner[436]. - Changes in patent law could have a material adverse effect on the ability to obtain and enforce new patents[441]. Operational Risks - The company relies on third-party partners for the development and commercialization of therapeutic candidates, which limits control over resources and timelines[307]. - The company does not have manufacturing facilities and relies on third-party manufacturers, which increases risks related to supply adequacy and compliance with regulations[317]. - The company is dependent on the integrity of its information technology systems, and any failure could disrupt operations and lead to financial losses[414]. Compliance and Regulatory Environment - Compliance with healthcare laws and regulations may involve substantial costs, and violations could lead to significant penalties, including exclusion from government-funded healthcare programs[348]. - The company may need to implement costly compliance programs if it expands operations internationally, particularly under the Foreign Corrupt Practices Act[361]. - The company faces potential limitations on growth and increased development costs due to U.S. laws restricting the dissemination of classified information and certain products outside the United States[363]. Strategic Partnerships and Collaborations - The company has entered into strategic collaborations, including exclusive licenses for programs related to amyotrophic lateral sclerosis (ALS) and its first clinical stage therapeutic candidate, MZE001[305]. - Partnerships may not lead to efficient development or commercialization, and failure to recognize their benefits could adversely affect the company's financial condition and prospects[309]. - The company has formed joint ventures and spin-outs, such as with Alloy Therapeutics in 2020, to develop therapeutic targets outside its core expertise[310]. Data Privacy and Security - The company is at risk of reputational damage and financial loss due to potential breaches of data privacy obligations by third-party service providers[380]. - Any perceived failure to comply with privacy laws could lead to enforcement actions, significant fines, and loss of customer trust, adversely affecting the company's business[381]. - The company may face significant penalties under the EU GDPR, including fines of up to €20 million or 4% of annual global revenue for non-compliance[377]. Employee and Growth Challenges - The company’s ability to attract and retain qualified personnel is critical for its success in the competitive biotechnology and pharmaceutical industries[408]. - The company plans to expand its employee base to enhance managerial, operational, and financial resources as part of its growth strategy[411]. - There is a risk of misconduct by employees and partners, which could lead to regulatory sanctions and harm the company's reputation[412]. Economic and Market Conditions - Unfavorable global economic conditions could adversely affect the company's business, financial condition, and stock price, potentially leading to weakened demand for therapeutic candidates[431]. - The company anticipates continued pricing pressures globally due to state and federal healthcare reform measures that may impose downward pressure on product prices[355]. - Recent legislative changes may increase the difficulty and cost of obtaining marketing approval and could negatively affect pricing and third-party payment for therapeutic candidates[349].

Maze Therapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Highlights MZE829 Phase 2 HORIZON Trial Enrolling Patients with APOL1 Kidney Disease (AKD); Initial Data Expected in Q1 2026 MZE782 Phase 1 Healthy Volunteer Trial Ongoing; Initial Data Expected in H2 2025 Raised $140 Million in Gross Proceeds in Upsized IPO in February 2025, Providing Expected Cash Runway into H2 2027 SOUTH SAN FRANCISCO, CA, March 31, 2025 – Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage bio ...

Table of Contents As filed with the Securities and Exchange Commission on January 29, 2025 Registration No. 333-284164 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MAZE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2836 82-2635018 (I.R.S. Emplo ...

Table of Contents As filed with the Securities and Exchange Commission on January 27, 2025 Registration No. 333-284164 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MAZE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 1 Delaware 2836 82-2635018 (I.R.S. Emplo ...

Table of Contents As filed with the Securities and Exchange Commission on January 7, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MAZE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 82-2635018 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) ...