globenewswire news

Completed enrollment in Phase 3 UPSTREAM MG trial of telitacicept in generalized myasthenia gravis; topline results remain on track for 1H27

Expanded telitacicept franchise into ocular myasthenia gravis with Phase 3 registrational UPSTREAM oMG trial; first patient dosing anticipated in 1H27

Enrollment ongoing for Phase 3 UPSTREAM SjD of telitacicept in primary Sjögren’s disease

Cash and investment balance of $481.6 million expected to provide runway into early 2029

BOSTON, Oct. 30, 2026 (GLOBE NEWSWIRE) --  Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today reported financial results for the third quarter ended September 30, 2026, and provided a corporate update.

“We ended the third quarter with UPSTREAM MG fully enrolled and three registrational clinical trials advancing across the MG spectrum and Sjögren’s disease,” said Jean-Paul Kress, M.D., Chairman and Chief Executive Officer of Vor Bio. “The final two-year Phase 3 TELIGAN results in IgAN from China add another important layer to the clinical evidence for telitacicept, demonstrating durable preservation of kidney function and sustained proteinuria reduction through 104 weeks. Taken together with the growing experience across autoimmune diseases, these data continue to strengthen our view of what dual BAFF and APRIL inhibition may be able to achieve over time. As we approach 2027, our focus is on generating the evidence that can define the role of telitacicept and establish Vor as a leading company in immunology.”

Program Highlights

Telitacicept: a potential best- and first-in-class dual BAFF/APRIL inhibitor in development for generalized myasthenia gravis (gMG) and primary Sjögren’s disease (SjD)

Generalized Myasthenia Gravis

• UPSTREAM MG
  • Enrollment complete in the global randomized, double-blind, placebo-controlled Phase 3 registrational trial with an open-label extension assessing the efficacy and safety of telitacicept in gMG
  • Topline data anticipated in 1H 2027
    

Primary Sjögren’s Disease

• UPSTREAM SjD
  • Enrollment ongoing in global randomized, double-blind, placebo-controlled Phase 3 registrational trial assessing the efficacy and safety of telitacicept in SjD

Corporate Updates

• Completed enrollment in UPSTREAM MG, the global Phase 3 registrational trial evaluating telitacicept in gMG
  
  
• Announced plans to initiate UPSTREAM oMG, a global Phase 3 registrational trial evaluating telitacicept in ocular myasthenia gravis, with first patient dosing anticipated in the first half of 2027
  
  
• Presented new 48-week analyses from the Phase 3 trial of telitacicept in gMG, conducted in China by collaborator RemeGen, at the 2026 AANEM Annual Meeting, including sustained MSE data showing that 42.1% of treated participants achieved MSE over 48 weeks and spent approximately 83% of subsequent follow-up in MSE after first achievement
  
  
• Presented final two-year results from the Phase 3 TELIGAN trial of telitacicept in IgA nephropathy, conducted in China by collaborator RemeGen, at the American Society of Nephrology (ASN) Kidney Week 2026, showing an annualized eGFR slope of -0.6 vs. -5.7 mL/min/1.73 m²/year for placebo (p<0.001) and sustained proteinuria reductions through 104 weeks
  

Third Quarter 2026 Financial Results

• Cash Position: Cash, cash equivalents and marketable securities were $481.6 million as of September 30, 2026, which are projected to fund operations into early 2029.
  
  
• R&D expenses for the third quarter of 2026 were $34.5 million, compared to $14.1 million for the third quarter of 2025. The increase of $20.4 million was primarily due to increased spending for our new programs, telitacicept in gMG and SjD, as well as increased personnel-related expenses as our research and development headcount increased compared to the prior year period as we continue to increase R&D activities.
  
  
• General & Administrative (G&A) Expenses: G&A expenses for the third quarter of 2026 were $23.9 million, compared to $14.0 million for the third quarter of 2025. The increase of $9.9 million was primarily due to increases in personnel-related expenses and stock-based compensation compared to the prior year period as our headcount grew to support the Company’s increase in operational activity.
  
  
• Net Loss: Net loss for the third quarter of 2026 was $86.7 million, compared to a $812.7 million net loss for the third quarter of 2025. The decrease in loss of $726.0 million was primarily due to the change in fair value of the outstanding liability-classified warrants in the third quarter of 2026 compared to the change in fair value recognized in the third quarter of 2025.
  

About Telitacicept
Telitacicept is a novel recombinant fusion protein designed to treat autoimmune diseases through dual inhibition of BLyS (BAFF) and APRIL - two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology.

Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), generalized myasthenia gravis (gMG), IgA nephropathy (IgAN), and Sjögren’s disease (SjD).

Vor Bio is advancing global development programs across major autoimmune indications, including a global Phase 3 trial in gMG and SjD, to support potential regulatory approvals in the United States, Europe, and Japan.

About Vor Bio
Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The Company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and potential commercialization to address serious autoantibody-driven conditions worldwide. For more information visit www.vorbio.com. Vor Bio routinely posts information that may be important to investors in the “Investors” section of its website. The Company encourages investors to consult that section of its website regularly.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “design,” “expect,” “initiate,” “may,” “on-track,” “ongoing,” “plan,” “potential,” “project,” “should,” “update,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio’s statements regarding telitacicept’s potential as a first-in-class and best-in-class BAFF/APRIL therapy for gMG and SjD; the potential benefits of the dual BAFF and APRIL inhibition; our plan to generate the evidence that can define the role of telitacicept and establish Vor as a leading company in immunology; Vor Bio’s projected cash runway; Vor Bio’s development and commercialization plans for telitacicept, including the pursuit of potential regulatory approvals in the United States, Europe, and Japan, having topline data from the UPSTREAM MG trial and dosing the first patient in the UPSTREAM oMG trial in the first half of 2027; and other statements that are not historical fact.

Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including that results from the TELIGAN trial, which RemeGen conducted solely in China, may not be predictive of results in other populations or in our ongoing or future clinical trials, and that the FDA and other regulators outside China may not accept data generated in China; that results of earlier clinical trials or analyses may not be predictive of future results, and that data presented at medical meetings may change following additional analysis or peer review; the risk of unexpected adverse events or safety findings; that conditional approvals in China may be withdrawn or not converted to full approval; our reliance on RemeGen, including for clinical data and the supply of telitacicept, and our ability to maintain our license with RemeGen; competition from other therapies, including other BAFF and/or APRIL inhibitors; that the data for our product candidates may not be sufficient for obtaining regulatory approval to commercialize products; we may not be able to execute our business plans, including meeting our planned clinical and regulatory milestones and timelines; and possible limitations of financial and other resources. The clinical trial results described in this press release are based on information reported by RemeGen; Vor Bio has not independently verified these data. These and other risks are described in greater detail under the caption “Risk Factors” included in Vor Bio’s most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. Statements regarding Vor Bio’s cash runway do not indicate when or if Vor Bio may access the capital markets.

Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law.

CONTACT: Media & Investor Contacts:
Carl Mauch
cmauch@vorbio.com