Candid Therapeutics Advances Portfolio of Novel T-Cell Engagers into Five Autoimmune Diseases for Clinical Evaluation

SAN DIEGO – Candid Therapeutics, Inc. (“Candid”), a clinical-stage biotechnology company redefining the treatment of autoimmune and inflammatory diseases through novel T-cell engagers (TCEs), today announced key operational and clinical milestones for its two lead clinical stage programs, cizutamig (BCMA TCE) and CND261 (CD20 TCE). Candid launched in the second half of 2024 with $370 million in financing and two in-licensed TCEs that had completed full Phase 1 dose escalation studies in oncology patients.

Emerging clinical data with TCEs have solidified our confidence that TCEs can become the most compelling modality across a range of diseases.

“We founded Candid on the conviction that T-cell engagers would become the largest therapeutic class in autoimmune diseases, surpassing the commercial success of TNF inhibitors such as Humira,” said Dr. Ken Song, Chairman, President, and Chief Executive Officer of Candid. “We are hyperfocused on execution to generate clinical data. Over the past few quarters, we have prioritized disease indications and built a foundation of key CMC and clinical operational activities to set a new benchmark for innovation, scale, and speed. Emerging clinical data with TCEs have solidified our confidence that TCEs can become the most compelling modality across a range of diseases.”

Key Highlights Reinforcing Candid’s Leadership Position:

• First patients dosed with cizutamig and CND261:
  • Patients with refractory rheumatoid arthritis and systemic sclerosis have been dosed at therapeutically active doses.
  • Both TCEs have been well tolerated and patients have shown early signs of promising clinical response and disease improvement.
• Industry-leading clinical study pipeline in motion:
  • Clinical studies are now in progress for IgA Nephropathy, Myasthenia Gravis, Rheumatoid Arthritis, Systemic Lupus Erythematosus and Systemic Sclerosis.
  • Additional clinical studies in high-value disease indications slated to launch in the 2H 2025.
  • Studies are designed to evaluate safety, pharmacokinetics, pharmacodynamic effects, and early signs of efficacy in patients with immunology and inflammatory diseases.
• CMC activities completed to enable global clinical trials:
  • Candid has invested significant resources to build an integrated Chemistry, Manufacturing, and Controls (CMC) infrastructure to support global development with the completion of several new drug product manufacturing runs.
  • Subcutaneous dosing formulations for both cizutamig and CND261 have been established.
• Strategic establishment of China operations:
  • To support clinical execution across multiple geographies, Candid has established a fully staffed legal entity in China.
  • The China based team includes professionals with deep expertise in regulatory, clinical development, and clinical operations.

With unmatched executional momentum and differentiated programs, Candid Therapeutics is defining a new future in immunology through its commitment to TCEs in autoimmune diseases. Additional trial initiations and clinical data disclosures are anticipated in the coming quarters.

About Candid Therapeutics

Candid Therapeutics is a clinical-stage biotechnology company focused on transforming the treatment of autoimmune and inflammatory diseases through novel T-cell engager (TCE) platforms. Candid is advancing two lead B-cell depleting TCE antibody drug candidates, with a goal to broadly explore the potential of TCEs across multiple autoimmune diseases by targeting different B-cell protein targets, as well as evaluating different depths of B-cell depletion. Established in 2024 and headquartered in San Diego, CA, Candid is led by a team of entrepreneurial executives who have a track record of advancing programs into and through development and is supported by a distinguished syndicate of premier life science investors.

About Cizutamig

Cizutamig is a bispecific antibody designed to simultaneously bind B-cell maturation antigen (BCMA) on B-cells and CD3 on T-cells, enabling T-cell–mediated cytotoxicity against BCMA-expressing B-cells. Originally developed and clinically evaluated in multiple myeloma, cizutamig has demonstrated patient experience in oncology settings and is now being investigated in autoimmune diseases where pathogenic B-cells play a critical role in disease progression. Cizutamig has the potential to deliver deep and selective B-cell depletion through its dual-targeting mechanism, offering a novel approach for treating a broad spectrum of immune-mediated disorders.

About CND261

CND261 is a bispecific antibody designed to target CD20 on B-cells and CD3 on T-cells, enabling T-cell mediated cytotoxicity against CD20-expressing B-cells. Engineered with low CD3 affinity, CND261 is optimized to reduce the risk of excessive T-cell activation while maintaining potent and selective B-cell depletion. The molecule has demonstrated patient experience in B-cell malignancies and is now being investigated in autoimmune diseases where pathogenic B-cells contribute to disease progression. CND261 represents a promising therapeutic candidate for immune-mediated disorders with the potential for improved safety and efficacy through its targeted mechanism of action.