Zucara Therapeutics Inc., (“Zucara” or the “Company”) a diabetes life sciences company developing ZT-01, the first once-daily therapeutic to prevent hypoglycemia (low blood glucose levels) in people with diabetes, today announced that it has completed the second and final closing of its US$25 million Series B Financing (the “Financing”).
The T1D Fund: A Breakthrough T1D Venture and other new investors invested a combined US$5 million to complete the Financing. As previously announced, strategic investor, Sanofi, and existing investor, The Perceptive Xontogeny Venture Fund (“PXV Fund I”), invested a combined US$20 million as part of the Financing’s first closing.
“We are thrilled to close our Series B financing, which will enable us to complete our Phase 2a clinical trial and the nonclinical activities to support a once-weekly version of ZT-01,” said Michael Midmer, CEO of Zucara. “As one of the largest disease-focused impact investing funds in the world, the T1D Fund focuses on funding therapies that have significant potential for clinical impact in Type 1 diabetes, so we are delighted to have their support.”
T1D Fund Managing Director, Sylvia Tobé, commented, “Our investment builds on funding that our parent organization, Breakthrough T1D, previously granted to Zucara to support the discovery and clinical development of ZT-01. Having followed Zucara for some time, we are excited to support the further advancement of this promising candidate that has the potential to address a common and potentially life-threatening complication of Type 1 diabetes.”
In connection to the Financing, Dr. Tobé will join Zucara as a Board Observer. Dr. Tobé is an experienced biotech industry professional with over a decade of experience in the sector. Prior to joining the T1D Fund, she was a Principal on the investment team at Omega Funds, where she focused on early-stage investments and company creation in various therapeutic areas. She also previously served at publicly traded Ra Pharmaceuticals, a peptide drug discovery company, where she provided scientific leadership for multiple discovery programs within its internal pipeline and in collaboration with Merck. Dr. Tobé is a Board Director at DiogenX and a Board Observer at various biotech companies across the auto-immune and regenerative spaces.
Proceeds from the Financing are expected to fund the remainder of Zucara’s ongoing Phase 2a trial of the effect of ZT-01 On Nocturnal hypoglycemia Events in Type 1 diabetes (“T1D”) mellitus (“ZONE”), and the nonclinical development of a once-weekly version of ZT-01.
About The T1D Fund
The T1D Fund is an impact investment fund focused on accelerating life-changing solutions to treat, prevent, and ultimately cure type 1 diabetes (T1D). Launched in December 2016, the T1D Fund is a unique, evergreen construct that is the first scaled, mission-driven venture fund established to catalyze the development of T1D cure-oriented therapies through equity investments. By partnering with additional sources of capital, including venture capital, corporations, and foundations, the T1D Fund is able to attract and effectively deploy capital towards disease-modifying therapies and potential cures for T1D. Managed by a dedicated team of investment professionals and supported by its foundational partners – including Breakthrough T1D (formerly JDRF) and the Helmsley Charitable Trust, the leading global organizations funding T1D research – the T1D Fund continues to pursue innovative approaches that have the curative potential to make a significant impact for people living with T1D. For more information, visit t1dfund.org or follow the T1D Fund on LinkedIn.
About ZT-01
ZT-01 is designed to prevent potentially dangerous low blood glucose by restoring the body’s ability to counter regulate hypoglycemia. In people without diabetes, α-cells secrete glucagon that signals the body to release its own glucose stores to prevent or reverse hypoglycemia. However, in people with insulin-dependent diabetes – including those with T1D and insulin-dependent Type 2 diabetes – evidence suggests that elevated secretion of pancreatic somatostatin suppresses glucagon release from α-cells. Zucara has demonstrated that, in people with T1D, the glucagon response can be increased with ZT-01, a first-in-class SST receptor 2 antagonist.
About Zucara Therapeutics Inc.
Zucara Therapeutics is developing ZT-01, a first-in-class, once-daily therapeutic to prevent hypoglycemia in people with T1D and insulin-dependent Type 2 diabetes. ZT-01 is designed to inhibit somatostatin, a pancreatic hormone that impairs the glucagon response to hypoglycemia in people with these conditions. ZT-01 is designed to restore glucagon secretion to prevent hypoglycemia, which could dramatically change diabetes disease management and improve both patient health and quality of life. For more information, visit www.zucara.ca.
For additional information, please contact:
Zucara Therapeutics: Michael Midmer, CEO at mmidmer@zucara.ca
Seattle, WA March 17, 2025: Mozart Therapeutics, the leading developer of CD8 Treg modulators for the treatment of autoimmune disease, today announce the successful completion of their Phase 1a study of MTX-101 in healthy adults. The randomized, blinded, placebo-controlled study evaluated MTX-101—a first-in-class autoimmune checkpoint inhibitor—at single and multiple doses in an ascending-dose design (NCT06324604).
Data from the study in healthy adults show MTX-101 is well tolerated. Most adverse events were low-grade and there were no serious adverse events. Participants receiving MTX-101 experienced transient and self-limited decreases in lymphocytes, which the Company believes are consistent with the study drug’s mechanism of action and indicative of target engagement.
Data further demonstrate that MTX-101 has predictable, dose-dependent pharmacokinetics (PK) and receptor occupancy that are expected to enable a convenient and competitive dosing regimen. Pharmacodynamic data support proof of mechanism and show that MTX-101 is highly selective for regulatory CD8 T cells, and that engagement with MTX-101 results in CD8 Treg activation.
Mozart plans to present full data from the Phase 1a study at upcoming medical symposia.
“We are thrilled that the initial MTX-101 phase 1 data in healthy adults confirm the mechanistic and safety findings from our pre- and nonclinical studies. This represents not only an important milestone for Mozart, but also a significant achievement as we work to advance a class of CD8 Treg modulators to restore durable immune homeostasis in autoimmune disease”, said Katie Fanning, President and Chief Executive Officer of Mozart Therapeutics.
“Our observations from the healthy adults hold great promise for patients with autoimmune disease,” echoed Jason Chien, M.D., M.S., Mozart’s Chief Medical Officer. “The well-tolerated safety profile, antibody-like PK, and clear evidence of target engagement and activation represent an exciting novel class of therapeutics that has the potential to deliver substantial clinical benefit. With these data, we are quickly advancing MTX-101 in patients with type 1 diabetes and celiac disease.”
The first patients with type 1 diabetes and celiac disease have been enrolled in Part B of the study, which is being conducted at multiple clinical sites in Australia. “MTX-101 has a novel mechanism of action that has great potential to improve the lives of people living with autoimmune disease,” said Professor John Wentworth, M.D.; Endocrinologist, The Royal Melbourne Hospital Department of Medicine; Senior Clinical Research Fellow, St Vincent’s Institute of Medical Research; Director, ANZ Type 1 Diabetes TrialNet. “This is why our type 1 diabetes community is so excited to participate in the MTX-101 development program and help determine its ability to decrease dependance on insulin injections.”
MOZART THERAPEUTICS
About MTX-101
MTX-101 is an antigen-agnostic bispecific antibody targeting inhibitory KIR and CD8 expressed on regulatory CD8 T cells. This autoimmune checkpoint inhibitor aims to restore the intrinsic functions of CD8 Treg, acting early in the autoimmune disease process to suppress and eliminate pathogenic T cells, halt downstream inflammation, and prevent tissue destruction.
About Mozart Therapeutics
Mozart Therapeutics is focused on developing first-in-class disease-modifying therapies for autoimmune diseases, utilizing a novel approach to restoring immune system function by targeting the CD8 T regulatory network. The company is headquartered in Seattle, WA. For more information, visit www.mozart-tx.com and follow the company on LinkedIn @Mozart-tx.com.