Zenas BioPharma מכריזה על הישגים מרכזיים לשנת 2024 ועל יעדים עסקיים לשנת 2025 לתמיכה בפיתוח ומסחור גלובליים של טיפולים למחלות אוטואימוניות

וולטהם, מסצ'וסטס, 5 בפברואר 2025 (GLOBE NEWSWIRE) –

Zenas BioPharma, Inc ("Zenas" או "החברה") (נאסד"ק: ZBIO), חברת ביו-פארמה גלובלית המחויבת להפוך למובילה בפיתוח ומסחור של טיפולים מכווני דלקות ואימונולוגיה, הודיעה היום על הישגיה לשנת 2024, פירטה את יעדיה העסקיים המרכזיים לשנת 2025 והכריזה על יתרת מזומנים ראשונית לא מבוקרת נכון לסוף שנת 2024.

Zenas BioPharma Announces Key 2024 Accomplishments and 2025 Business Objectives to Support the Global Development and Commercialization of Therapies for Autoimmune Diseases

- Advancing Phase 2 and Phase 3 trials of obexelimab, a unique CD-19 x FcγRIIb inhibitor of B cell function-

-Topline results from Phase 2 Trial in Relapsing Multiple Sclerosis (MoonStone) expected in third quarter 2025-

-Topline results from pivotal Phase 3 Trial in Immunoglobulin G4-Related Disease (INDIGO) expected year-end 2025-

- Enrollment of Phase 2 Trial in Systemic Lupus Erythematosus (SunStone) expected to be completed in 2025-

- Out-licensed greater-China anti-IGF-1R Thyroid Eye Disease programs to Zai Lab -

WALTHAM, Mass., Feb. 05, 2025 (GLOBE NEWSWIRE) –

Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of therapies for autoimmune diseases, today announced its 2024 accomplishments, outlined its key business objectives for 2025 and announced preliminary unaudited cash balance as of year-end 2024.

“Based upon the progress achieved across all of our corporate goals and objectives during 2024, we enter 2025 with an opportunity to achieve major value-driving milestones with the anticipated results from our ongoing obexelimab Phase 2 and Phase 3 clinical trials,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “We are extremely proud of the accomplishments of our dedicated team as we enter the year well-financed and able to focus on execution, and achievement of our key objectives for the year.”

The Company enters 2025 well-capitalized to deliver its key milestones with approximately $350 million in cash, cash equivalents, and short-term investments as of December 31, 2024, ¹ which is expected to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026.

2024 Accomplishments and Recent Achievements

During 2024, the Company achieved the following objectives and announced a recent business development transaction:

• Completedenrollment of the Phase 3 INDIGO trial, a global Phase 3registration-directed, randomized, double-blind placebo-controlled trialof obexelimab in patients with Immunoglobulin-G4 Related Disease(IgG4-RD), the largest clinical trial ever conducted in this patientpopulation.

• Initiated thePhase 2 MoonStone trial, a Phase 2, multicenter, randomized,double-blind, placebo-controlled trial, to evaluate the efficacy andsafety of obexelimab in patients with Relapsing Multiple Sclerosis (RMS).

• Initiated thePhase 2 SunStone trial, a Phase 2, multicenter, randomized,double-blind, placebo-controlled trial, to evaluate the efficacy andsafety of obexelimab to reduce disease activity in patients with SystemicLupus Erythematosus (SLE).

• Provided initialdata from the Phase 2 SApHiAre trial, a global, multicenter, open-labelsafety and dose confirmation run-in period (SRP) to evaluate the safetyand activity of obexelimab in patients with warm Autoimmune HemolyticAnemia (wAIHA). Obexelimab achieved clinical proof-of-mechanism byincreasing hemoglobin levels and red blood cells, and decreasing LDH andtotal bilirubin levels. Obexelimab was well tolerated in the SRP.

• Completed anupsized Series C and initial public offering, raising approximately $458.7million in aggregate gross proceeds to fund its planned activities forobexelimab and the Company’s growth strategy.

• Bolstered itsleadership team with the appointments of Chief Commercial Officer, OrlandoOliveira, and Chief Legal Officer, Jeff Held.

• Out-licensedZB005, a human IgG4 monoclonal antibody designed to bind only to theactive form of C1s, for which Zenas held the development andcommercialization rights in China, Hong Kong, Macau and Taiwan (GreaterChina) through an exclusive license with Dianthus.

• The Companyrecently out-licensed regional rights to its thyroid eye disease programs,including ZB001, an insulin-like growth factor-1 receptor (anti-IGF-1R)monoclonal antibody, to Zai Lab (Zai).  Zenas received an upfront feeand is eligible to receive milestone payments and royalties in the future,as consideration for an exclusive sublicense to Zai to develop andcommercialize ZB001 and related programs in Greater China.

Anticipated 2025 Clinical Milestones for Obexelimab

Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self-administered, subcutaneous once-weekly injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Obexelimab has been evaluated in five completed clinical trials in a total of 198 patients who received obexelimab either as an intravenous infusion or as a subcutaneous injection. Obexelimab was well tolerated and demonstrated clinical activity across these five clinical trials, providing the Company an initial clinical proof of concept for obexelimab as a potent B cell inhibitor for the treatment of patients living with certain autoimmune diseases.

During 2025, the Company expects to achieve the following key clinical milestones:

• Report the 12-weekprimary endpoint results in the third quarter of 2025 from the Phase 2MoonStone trial in patients with RMS.

The role of B cells in the pathogenesis of multiple sclerosis including RMS has been demonstrated through the successful clinical development, approval and clinical use of anti-CD20 B cell targeting therapies of other companies, including OCREVUS® (ocrelizumab) and KESIMPTA® (ofatumumab), which selectively deplete CD20-expressing B cells. The Company believes obexelimab’s unique mechanism of action to potently inhibit but not deplete a broader B cell lineage than CD20, nonclinical data, and a subcutaneous injection regimen, supports its potential for the treatment of RMS.

• Following aninitial screening period, patients in the MoonStone trial are beingrandomized 2:1 to 250 mg of obexelimab or placebo administered as asubcutaneous injection every seven days for a 12-week treatment period.
• The primaryobjective of this double-blinded portion of the trial will be to assessthe change from baseline in the cumulative number of gadolinium (Gd)enhancing lesions identified on T1-weighted magnetic resonance imaging(MRI).
• Upon completion ofthe 12-week period, patients will enter an open-label period wherepatients on placebo will receive obexelimab treatment for at least threemonths, and patients initially randomized to obexelimab will continuetreatment.
• Importantsecondary endpoints during this open-label period include usingstandardized assessments, novel 3D imaging and biomarkers, including serumneurofilament light chain (NfL), to evaluate the impact of obexelimab ondisease progression.

More information on the Phase 2 MoonStone trial (NCT06564311) is available at clinicaltrials.gov

• Report toplineresults year-end 2025 from the Phase 3 INDIGO trial in patients withIgG4-RD.

IgG4-RD is a chronic fibro-inflammatory disease that can affect virtually all organ systems, including the pancreas, biliary tract, salivary and lacrimal glands, lungs, and kidneys. Patients with IgG4-RD may present with a single organ involved but more frequently present with multiple organ involvement. As the disease progresses and patients experience new or worsening symptoms (i.e., flares), lesions develop in additional organs and the cellular inflammation characterizing early disease moves toward a more fibrotic stage, which can lead to major irreversible tissue damage and ultimately organ failure. We estimate that the currently diagnosed population of IgG4-RD patients in the U.S. is approximately 20,000, with comparable prevalence rates globally.

Despite the growing recognition of IgG4-RD and advances in the understanding of its pathophysiology, there are no approved therapies for the treatment of this disease and there remains high unmet medical need. The current standard of care is treatment with glucocorticoids (GCs). Although GCs are initially effective, treatment with GCs can often result in various complications and co-morbidities. Most patients can relapse within 12 months of discontinuing GC treatment, and maintenance therapy with GCs has not been shown to prevent recurrence of disease.

The pathogenesis of IgG4-RD suggests that B cell-targeted therapies may provide therapeutic benefit. Although not approved by any regulatory authorities to treat IgG4-RD, certain B cell depleting agents (e.g., rituximab) are occasionally administered to patients with IgG4-RD. However, B cell depleting agents are often associated with infections, including serious opportunistic infections, and can compromise a patient’s ability to mount a response to vaccinations.

The reported evidence for the role of B cells in the pathogenesis of IgG4-RD, the observed effects of B cell targeting agents in previous trials in IgG4-RD, the data from our Phase 2 IgG4-RD trials with obexelimab, and its unique, non-depleting mechanism and once-weekly, subcutaneous injection regimen support its development in patients with IgG4-RD.

• INDIGO is thelargest clinical trial conducted in patients living with IgG4-RD and isdesigned to evaluate the safety and efficacy of obexelimab inapproximately 190 patients with active IgG4-RD and being conducted atapproximately 100 sites in 20 countries.
• Following aninitial screening period, patients were randomized 1:1 to 250 mg ofobexelimab or placebo administered as a subcutaneous injection every sevendays for 52 weeks, followed by an opportunity for eligible patients tocontinue in an open-label extension period where all patients will receivetreatment with obexelimab.
• The primaryefficacy endpoint of INDIGO is the time to first IgG4-RD flare, asdetermined per protocol by the investigator and the adjudicationcommittee.
• Secondaryendpoints include annualized flare rate, the proportion of patientsachieving complete remission, and use and quantity of rescue medication,including GCs.

More information on the Phase 3 INDIGO trial (NCT05662241) is available at clinicaltrials.gov

• Completeenrollment in 2025 in the Phase 2 SunStone trial in patients with SLE andreport topline results in the first half of 2026.

The crucial role of B cells in SLE pathogenesis is well recognized, from producing autoantibodies to abnormal regulation of immune responses. Moreover, SLE is an autoimmune disease characterized by B cell dysfunction, the production of autoantibodies toward cellular and nuclear components, and multiorgan damage caused by immune complex deposition and inflammation within affected tissues. Current treatments are limited in number and modestly effective. Obexelimab has demonstrated clinical activity in a prior Phase 2 double-blind, randomized trial demonstrating proof-of-concept in the overall trial population and increased response in patients who maintained higher systemic exposure to obexelimab, and also in biomarker-defined subpopulations. Coupled with the safety data obtained to date, we believe these data provide support for the development of obexelimab in patients with SLE.

• Patients withactive SLE determined at screening by the investigator and adjudicationcommittee are randomized 1:1 to obexelimab 250 mg or placebo administeredas a subcutaneous injection every seven days for 24 weeks.
• The 250 mgonce-weekly subcutaneous injection dose has been selected to maximize thepotential for clinical activity as higher systemic exposure (C_trough)correlated with greater clinical activity in the prior Phase 2 trial inSLE.
• The primaryendpoint is the percentage of responders, defined by BILAG-basedComposite Lupus Assessment, with a reduction of SLE disease activity atweek 24.
• Biomarker analysisis planned to be conducted in all patients, including baseline RNAexpression profiles to immunophenotype patients and evaluation of theirdifferential responses to treatment.

More information on the Phase 2 SunStone trial (NCT06559163) is available at clinicaltrials.gov

About Zenas BioPharma, Inc.

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas’ lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on LinkedIn.

The Zenas BioPharma word mark and logos are trademarks of Zenas BioPharma, Inc. or its affiliated companies.

Investor Contact:

Matthew Osborne

Investor Relations and Corporate Communications
[email protected]

Media Contact:

Argot Partners
[email protected]

¹ This amount is preliminary and unaudited and is subject to completion of the Company’s financial closing procedures. As a result, this amount may differ materially from the amount that will be reflected in the Company’s consolidated financial statements for the year ended December 31, 2024.

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