PresentationJason ColomaCEO & Director Good morning, everyone. I'm Jason Coloma. I'm the CEO of Maze Therapeutics. And first of all, I'd like to thank the Jefferies team for inviting us to this year's conference. I'd also like to acknowledge our forward-looking statements. At Maze, our mission is simple, yet ambitious, to harness the power of human genetics to transform the lives of patients. An emphasis for us is chronic kidney disease. Kidney disease is a silent killer. Over 800 million individuals global ...

Maze Therapeutics (NasdaqGM:MAZE) 2025 Conference November 20, 2025 07:00 AM ET Company ParticipantsJason Coloma - CEOJason ColomaMorning, everyone. I'm Jason Coloma. I'm the CEO of Maze Therapeutics. First of all, I'd like to thank the Jefferies team for inviting us to this year's conference. I'd also like to acknowledge our forward-looking statements. At Maze, our mission is simple yet ambitious: to harness the power of human genetics to transform the lives of patients. An emphasis for us is chronic kidne ...

Summary of Maze Therapeutics Conference Call Company Overview - **Company**: Maze Therapeutics (NasdaqGM:MAZE) - **Focus**: Development of small molecule precision medicines, primarily targeting kidney diseases, particularly APOL1-mediated kidney disease [4][11] Key Highlights from the American Society of Nephrology (ASN) Conference - **Abstracts**: Maze Therapeutics had seven abstracts accepted at ASN, showcasing significant research contributions [4] - **Genotyping Study**: - Previous literature indicated that approximately 13% of the general population has pathogenic variants causing APOL1 kidney disease - Maze's study found about 18% prevalence in enriched kidney disease patients, indicating a higher incidence due to the specific population studied [5][6] - Approximately 1 million individuals in the U.S. have these variants, with at least 250,000 potentially benefiting from therapy [5] - Breakdown: 40% of affected individuals have diabetes, while 60% do not [6] - **Disease Progression**: - The progression of APOL1-mediated kidney disease occurs at similar rates in patients with and without diabetes [6][7] - A protective variant, N264K, was identified, showing protective effects regardless of diabetes status [7][19] Mechanistic Insights - **Pathogenic Mechanism**: APOL1 variants lead to nephrotoxicity through aberrant pore channel function in podocytes [9][10] - **Therapeutic Approach**: Maze's dual mechanism APOL1 inhibitor aims to block the pore and disrupt its assembly, showing significant potency advantages in preclinical models [11][12] Clinical Development Plans - **Maze 829 Program**: - Aiming for clinical proof of concept (POC) in broad APOL1-mediated kidney disease by Q1 2026, targeting a minimum 30% reduction in proteinuria [12][13] - The 30% threshold is based on historical data correlating with clinical significance and regulatory guidelines [21][23] - **Patient Cohorts**: Expecting data from both diabetes and non-diabetes cohorts, with a focus on demonstrating POC in a broader patient population [14][15] Market Potential - **Patient Population**: The broader AMKD landscape includes approximately 250,000 patients, significantly larger than the FSGS population [31][32] - **Comparative Advantage**: Maze aims to differentiate its therapy from existing treatments like inaxaplin by demonstrating superior efficacy and safety profiles [34][44] Additional Insights on SLC6A19 (782) Program - **PKU Treatment**: The therapy targets severe classical PKU, aiming to reduce plasma phenylalanine levels significantly, with a goal of improving patient outcomes [39][40] - **CKD Insights**: The program has shown promise in improving kidney health, with genetic associations and in vivo proof of concept supporting its efficacy [41][42] Conclusion - Maze Therapeutics is positioned to potentially lead in the treatment of APOL1-mediated kidney disease with its innovative therapeutic approaches and significant market opportunity, while also exploring promising avenues in PKU and CKD treatments [44][46]

Maze Therapeutics (NasdaqGM:MAZE) FY Conference November 12, 2025 08:00 AM ET Speaker0Of health care innovations conference. I am Debjit, one of the therapeutic analyst, and our my privilege to host our next presenting company, Mays Therapeutics. And joining us from Mays is Jason Coloma, the CEO. I don't think people are completely up to speed with May's as yet given you're a 20 class of 2025 IPO. Couple of minutes on the platform.Yeah. Well, first of all,Speaker1thank you for having us this year, Debjit, a ...

Financial Performance - For the three and nine months ended September 30, 2025, the company incurred a net loss of $30.1 million and $96.6 million, respectively, compared to a net loss of $24.8 million and net income of $81.8 million for the same periods in 2024 [103]. - The company recorded a net loss of $30.1 million for the three months ended September 30, 2025, compared to a net loss of $24.8 million in 2024 [130]. - License revenue for the three and nine months ended September 30, 2025, was $0, compared to $2.5 million and $167.5 million for the same periods in 2024, primarily due to the absence of new license agreements [131]. - Total operating expenses for the three months ended September 30, 2025, were $32.965 million, an increase of $6.236 million from $26.729 million in 2024 [130]. - Income tax benefit (expense) was zero for the three and nine months ended September 30, 2025, compared to a benefit of $0.3 million and an expense of $1.4 million in 2024 [139]. Cash and Capital - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities of $383.9 million, following an initial public offering that raised gross proceeds of $140.0 million in February 2025 and a private placement that raised $150.0 million in September 2025 [104]. - The company completed its initial public offering in February 2025, issuing 8,750,000 shares at $16.00 per share, resulting in net proceeds of approximately $127.8 million [141]. - In September 2025, the company raised approximately $141.3 million through a private placement, selling 4,000,002 shares at $16.25 each and Pre-Funded Warrants [142]. - The company anticipates needing additional capital to fund operations and develop therapeutic candidates, with ongoing expenses expected to increase [144]. - The company may seek to raise capital through various means, including equity or debt financings, but adequate funding may not be available on acceptable terms [145]. Research and Development - The company expects significant increases in research and development expenses due to planned clinical trials for MZE829 and MZE782, further development of the Compass platform, and potential IND applications [103]. - Research and development expenses increased to $25.2 million for the three months ended September 30, 2025, from $19.9 million in 2024, reflecting a $5.3 million increase driven by higher personnel-related costs and clinical trial expenses [132]. - Research and development expenses for the nine months ended September 30, 2025, were $80.9 million, up from $61.3 million in 2024, marking a $19.6 million increase [133]. - The company plans to initiate two Phase 2 proof-of-concept trials for MZE782 in 2026, focusing on plasma Phe reduction in phenylketonuria and proteinuria reduction in chronic kidney disease [111]. - MZE782 demonstrated a favorable plasma pharmacokinetics profile with a half-life of 11 hours and consistent absorption, supporting a once- or twice-daily dosing regimen for future trials [109]. Operating Losses and Deficits - As of September 30, 2025, the company had an accumulated deficit of $455.0 million and does not expect positive cash flows from operations in the foreseeable future [103]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future, relying on financing through equity offerings and collaborations [102]. - The company incurred significant operating losses since inception, with expectations of increasing losses due to ongoing research and development activities [103]. - The company retains approximately 48% equity in Broadwing Bio LLC, a spin-out company formed to develop therapeutic antibody therapies, but expects dilution from convertible notes issued by Broadwing [106]. Other Financial Information - Interest and other income, net was $2.9 million for the three months ended September 30, 2025, up from $1.8 million in 2024, reflecting higher cash and marketable securities balances [137]. - Net cash used in operating activities was $84.2 million for the nine months ended September 30, 2025, compared to net cash provided of $98.4 million for the same period in 2024 [153]. - Net cash used in investing activities was $67.6 million for the nine months ended September 30, 2025, primarily due to purchases of marketable securities [154]. - Net cash provided by financing activities was $271.7 million for the nine months ended September 30, 2025, significantly up from $22.6 million in the same period in 2024 [155]. - The company has obligations of $4.6 million under consortium agreements with the University of Helsinki and Queen Mary University through December 31, 2027 [149]. Lease Obligations - The company has an operating lease for its headquarters in South San Francisco, which terminates in November 2030, with an option to extend for an additional eight years [148].

Financial Position - Maze Therapeutics reported a cash position of $383.9 million as of September 30, 2025, up from $196.8 million as of December 31, 2024, providing a cash runway into 2028[6]. - The company’s total stockholders' equity improved to $379.4 million as of September 30, 2025, compared to a deficit of $311.2 million as of December 31, 2024[18]. Revenue and Expenses - The company recognized no license revenue during the three and nine months ended September 30, 2025, compared to $2.5 million and $167.5 million for the same periods in 2024, respectively[7]. - Research and Development (R&D) expenses for Q3 2025 were $25.2 million, an increase from $19.9 million in Q3 2024, primarily due to higher clinical trial and manufacturing expenses[8]. - General and Administrative (G&A) expenses for Q3 2025 were $7.8 million, compared to $6.9 million in Q3 2024, reflecting higher personnel-related expenses[9]. - The net loss for Q3 2025 was $30.1 million, compared to a net loss of $24.8 million for the same period in 2024[10]. Clinical Trials and Development - Maze plans to initiate two Phase 2 proof-of-concept trials for MZE782 in phenylketonuria (PKU) and chronic kidney disease (CKD) in 2026[11]. - Enrollment is ongoing in the Phase 2 HORIZON trial of MZE829, with topline proof-of-concept data expected by the end of Q1 2026[3]. - MZE829 is being developed as a potential treatment for APOL1-mediated kidney disease (AMKD), which affects over one million people in the U.S.[3]. Fundraising Activities - Maze announced an oversubscribed private placement for gross proceeds of approximately $150.0 million in September 2025[11].

Core Insights - Maze Therapeutics has reported positive first-in-human results from the Phase 1 trial of MZE782, indicating its potential as a best-in-class therapy for phenylketonuria (PKU) and a first-in-class treatment for chronic kidney disease (CKD) [2][4][7] - The company is actively enrolling patients in the Phase 2 HORIZON trial of MZE829 for APOL1-mediated kidney disease (AMKD), with topline data expected by the end of Q1 2026 [2][6] - Maze Therapeutics has a strong financial position with $383.9 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2028 [9][20] Program Progress and Anticipated Milestones - MZE829 is being developed as a treatment for AMKD, which affects over one million people in the U.S. [3] - MZE782 targets the solute transporter SLC6A19 and aims to reduce plasma phenylalanine levels in PKU and proteinuria in CKD, with Phase 2 trials planned for 2026 [4][7] Recent Corporate Highlights - In October 2025, Maze appointed Hervé Hoppenot as chairman of its board of directors [5] - The company announced an oversubscribed private placement in September 2025, raising approximately $150 million [16] Financial Performance - For Q3 2025, Maze reported a net loss of $30.1 million, compared to a net loss of $24.8 million in Q3 2024 [13] - Research and development expenses increased to $25.2 million for Q3 2025, up from $19.9 million in Q3 2024, reflecting higher clinical trial costs [11] - General and administrative expenses rose to $7.8 million for Q3 2025, compared to $6.9 million in Q3 2024 [12]

Core Insights - Maze Therapeutics is presenting seven studies at the American Society of Nephrology's Kidney Week, focusing on their lead programs MZE782 and MZE829, which target chronic kidney disease (CKD) and phenylketonuria (PKU) [1][2][3] Group 1: Company Overview - Maze Therapeutics is a clinical-stage biopharmaceutical company developing small molecule precision medicines for kidney and metabolic diseases [1][7] - The company utilizes its Compass platform to pursue genetically validated targets, integrating variant discovery and functionalization [7] Group 2: Product Pipeline - MZE782 is an oral SLC6A19 inhibitor aimed at treating PKU and CKD, showing a strong safety profile and potential to improve kidney function in Phase 1 trials [2][6] - MZE829 is an oral APOL1 inhibitor in Phase 2 development for APOL1-mediated kidney disease (AMKD), which affects over one million people in the U.S. [2][4] - The HORIZON trial for MZE829 is currently enrolling patients and aims to provide initial topline results in Q1 2026 [5] Group 3: Research Presentations - Presentations at ASN include studies on the genetic variants of APOL1 in kidney disease, the effects of small molecule inhibitors on dysfunctional signaling, and the impact of SLC6A19 variants on kidney function [3][4] - Specific presentation titles include studies on APOL1 risk variants, SLC6A19 inhibition, and pharmacokinetics of MZE782 [3]

Core Insights - Maze Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule precision medicines for kidney and metabolic diseases, including obesity [2] - The company will participate in four upcoming investor conferences, providing live webcasts and archived presentations [1][3] Company Overview - Maze Therapeutics utilizes human genetics to create novel small molecule precision medicines, guided by its Compass™ platform [2] - The company's leading pipeline products include MZE829, a dual-mechanism APOL1 inhibitor in Phase 2 for APOL1-mediated kidney disease, and MZE782, a SLC6A19 inhibitor advancing to Phase 2 for phenylketonuria and chronic kidney disease [2] Upcoming Events - The company will engage in the following investor conferences: - Guggenheim 2nd Annual Healthcare Innovation Conference on November 11, 2025, at 9:30 a.m. ET [3] - TD Cowen Immunology & Inflammation Summit on November 13, 2025, at 2:00 p.m. ET [3] - Jefferies Global Healthcare Conference in London on November 20, 2025, at 12:00 p.m. GMT / 7:00 a.m. ET [3] - 8th Annual Evercore Healthcare Conference on December 3, 2025, at 10:25 a.m. ET [3]

Core Insights - The biotech sector is experiencing significant momentum, with many clinical-stage and commercial biopharma stocks reaching new 52-week highs due to breakthrough trial data, strategic deals, and earnings surprises [1] Company Summaries - **Metsera Inc. (MTSR)**: A clinical-stage biopharmaceutical company focused on developing hormone analog peptides for obesity and related metabolic diseases. Recently, Novo Nordisk made a $9 billion unsolicited acquisition proposal, which Metsera's board considers superior to its existing agreement with Pfizer [2][3]. Metsera announced positive Phase 2b results for its GLP-1 receptor agonist MET-097i, showing up to 14.1% weight loss after 28 weeks, supporting Phase 3 initiation in late 2025 [4]. The stock rose from $32.35 to a 52-week high of $66.10, a gain of 104.3% [5]. - **Indivior Plc (INDV)**: Develops buprenorphine-based therapies for opioid dependence. The company reported Q3 net income of $42 million, up from $22 million a year ago, with adjusted earnings of $93 million, exceeding Wall Street's expectations [6][7]. The stock increased from $20.86 to a 52-week high of $30.55, reflecting a 46.5% gain [7]. - **Insmed Inc. (INSM)**: Focused on therapies for serious and rare diseases, Insmed reported a Q3 net loss of $370 million but saw net product revenue rise to $142.3 million from $93.4 million last year [8][9]. The company raised its full-year 2025 revenue guidance for ARIKAYCE to $420 million - $430 million, indicating 15% - 18% growth year-over-year [10]. The stock surged from $76.54 to a 52-week high of $194.70, marking a 154.4% gain [10]. - **Ventyx Biosciences Inc. (VTYX)**: A clinical-stage biotech company developing therapies for autoimmune and neurodegenerative diseases. Ventyx reported positive Phase 2 results for its NLRP3 inhibitor VTX3232, showing strong safety and tolerability [11][13]. The stock rose from $3.01 to a 52-week high of $8.52, a gain of over 183% [14]. - **Inhibrx Biosciences Inc. (INBX)**: Focuses on oncology and rare diseases, announcing positive topline results from its ChonDRAgon study for ozekibart in chondrosarcoma [15]. The stock increased from $18.35 to a 52-week high of $83.78, representing a gain of 356.6% [16]. - **ABIVAX Société Anonyme (ABVX)**: Developing therapies for chronic inflammatory diseases, ABIVAX presented positive Phase 3 data for obefazimod in ulcerative colitis [17]. The stock rose from $7.83 to an all-time high of $106.73, marking a significant gain of 1263% [18]. - **Arrowhead Pharmaceuticals Inc. (ARWR)**: Developing RNAi-based therapies, Arrowhead finalized a licensing agreement with Novartis for ARO-SNCA, with financial terms including a $200 million upfront payment [19][20][21]. The stock increased from $29.70 to a 52-week high of $43.33, representing a gain of over 45% [21]. - **Kodiak Sciences Inc. (KOD)**: Focused on retinal diseases, Kodiak announced positive Phase 1b data for KSI-101, showing significant vision improvements [22][23][24]. The stock climbed from $8.98 to a 52-week high of $21.17, delivering a 135.7% gain [22]. - **Arcutis Biotherapeutics Inc. (ARQT)**: Focused on dermatological treatments, Arcutis reported Q3 net income of $7.4 million, a turnaround from a net loss last year, with revenue up 122% year-over-year [25][26]. The stock rose from $14.99 to a 52-week high of $27.08, representing a gain of over 80% [27]. - **Maze Therapeutics Inc. (MAZE)**: Developing precision therapies for various diseases, Maze announced positive Phase 1 results for MZE782 and secured $150 million in a private placement [28][29]. The stock rose from $11.21 to a new 52-week high of $34.29, returning a gain of 206% [29]. - **Supernus Pharmaceuticals Inc. (SUPN)**: Focused on CNS disorders, Supernus is expected to report Q3 earnings of $0.82 per share and revenue of $180.22 million [30][31]. The stock increased from $38.21 to a 52-week high of $57.65, representing a gain of over 50% [31].