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Vor Bio Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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Vor Bio (NASDAQ: VOR) reported Q3 2025 results and a broad clinical and corporate update on November 13, 2025. Multiple Phase 3 readouts for telitacicept showed positive efficacy and favorable safety across indications: gMG (96.2% ≥3‑point MG‑ADL response at 48 weeks), Sjögren’s disease (placebo‑adjusted ESSDAI −3.8; 71.8% vs 19.3% ≥3‑point ESSDAI at 24 weeks), SLE (67.1% vs 32.7% modified SRI‑4 at Week 52), and IgA nephropathy (55% reduction in 24h‑UPCR at 39 weeks). Corporate: raised expected gross proceeds of $115 million in Nov 2025 offering; cash and marketable securities were $170.5M as of Sept 30, 2025, projected to fund operations into Q2 2027.

Q3 financials show a net loss of $812.7M driven by a loss on warrant liabilities and total liabilities of $2.402B.

Vor Bio (NASDAQ: VOR) ha riportato i risultati del terzo trimestre 2025 e un ampio aggiornamento clinico e societario il 13 novembre 2025. Diverse letture di fase 3 per telitacicept hanno mostrato efficacia positiva e sicurezza favorevole in diverse indicazioni: gMG (risposta ≥3‑punti MG‑ADL del 96,2% a 48 settimane), malattia di Sjögren (ESSDAI aggiustato per placebo −3,8; 71,8% contro 19,3% ≥3‑punti ESSDAI a 24 settimane), LES (SLE) (67,1% vs 32,7% modificato SRI‑4 a Week 52), e nefropatia da IgA (riduzione del 55% di 24h‑UPCR a 39 settimane). Aspetti societari: ha aumentato i proventi lordi attesi di $115 million in un''offerta di novembre 2025; cassa e titoli negoziabili erano $170.5M al 30 settembre 2025, previsti per finanziare le operazioni fino al secondo trimestre 2027.

Le finanze del terzo trimestre mostrano una perdita netta di $812.7M trainata da una perdita su obbligazioni warrant e passività totali di $2.402B.

Vor Bio (NASDAQ: VOR) informó resultados del tercer trimestre de 2025 y una amplia actualización clínica y corporativa el 13 de noviembre de 2025. Múltiples resultados de fase 3 para telitacicept mostraron eficacia positiva y seguridad favorable en todas las indicaciones: gMG (96,2% de respuesta ≥3 puntos en MG‑ADL a las 48 semanas), enfermedad de Sjögren (ESSDAI ajustado por placebo −3,8; 71,8% vs 19,3% ≥3 puntos ESSDAI a las 24 semanas), LES (SLE) (67,1% vs 32,7% SRI‑4 modificado a la Semana 52), y nefropatía por IgA (reducción del 55% en 24h‑UPCR a las 39 semanas). Corporativo: captó ingresos brutos esperados de $115 millones en la oferta de noviembre de 2025; caja y valores negociables eran $170,5 millones al 30 de septiembre de 2025, proyectados para financiar operaciones hasta el 2T 2027.

Los resultados del 3T muestran una pérdida neta de $812,7 millones impulsada por una pérdida en pasivos por warrants y pasivos totales de $2,402 millones.

Vor Bio (NASDAQ: VOR)는 2025년 11월 13일 2025년 3분기 실적 및 광범위한 임상·기업 업데이트를 발표했습니다. telitacicept의 다수의 3상 결과가 여러 적응증에서 긍정적인 효능과 우수한 안전성을 보여주었습니다: gMG(48주 시점 MG‑ADL ≥3포인트 반응 96.2%), 쇼그렌 증후군(위약 대비 ESSDAI −3.8; 24주에 ≥3포인트 ESSDAI 71.8% 대 19.3%), SLE(52주에 수정된 SRI‑4 67.1% 대 32.7%), IgA 신증(39주에 24h‑UPCR 55% 감소). 기업 면에서 2025년 11월 공모를 통해 예상 총수익 $115 million을 증가시켰고, 2025년 9월 30일 기준 현금 및 시장성 증권은 $170.5M으로 2027년 2분기까지 운영 자금을 조달할 전망입니다.

3분기 재무는 워런트 부채 손실 및 총부채가 $2.402B인 가운데 순손실 $812.7M을 기록했습니다.

Vor Bio (NASDAQ: VOR) a publié les résultats du T3 2025 et une vaste mise à jour clinique et commerciale le 13 novembre 2025. Plusieurs résultats de phase 3 pour telitacicept ont montré une efficacité positive et une sécurité favorable dans diverses indications : gMG (réponse MG‑ADL ≥3 points à 48 semaines, 96,2%), maladie de Sjögren (ESSDAI ajusté par placebo −3,8 ; 71,8% vs 19,3% ≥3 points ESSDAI à 24 semaines), LES (SLE) (67,1% vs 32,7% SRI‑4 modifié à la semaine 52), et néphropathie à IgA (réduction de 55% du 24h‑UPCR à 39 semaines). Corporate : les recettes brutes prévues augmentées de $115 millions lors de l’offre de novembre 2025 ; la trésorerie et les valeurs mobilières s’élevaient à $170,5M au 30 septembre 2025, prévues pour financer les opérations jusqu’au 2e trimestre 2027.

Les résultats du T3 montrent une perte nette de $812,7M due à une perte sur les passifs dérivés d’options et à des passifs totaux de $2,402B.

Vor Bio (NASDAQ: VOR) berichtete am 13. November 2025 die Ergebnisse des Q3 2025 sowie ein umfassendes klinisches und unternehmerisches Update. Mehrere Phase-3‑Auswertungen für telitacicept zeigten Wirksamkeit und sichere Verträglichkeit über Indikationen hinweg: gMG (96,2% ≥3‑Punkte MG‑ADL‑Reaktion nach 48 Wochen), Sjögren‑Syndrom (placebo‑adjusted ESSDAI −3,8; 71,8% vs 19,3% ≥3‑Punkte ESSDAI nach 24 Wochen), SLE (67,1% vs 32,7% modifiziertes SRI‑4 nach Woche 52) und IgA‑Nierenerkrankung (55% Reduktion von 24h‑UPCR nach 39 Wochen). Unternehmensseitig: erwartete Bruttoerlöse von $115 Millionen durch die November-2025‑Emission erhöht; Kasse und handelbare Wertpapiere betrugen $170,5M zum 30. September 2025 und sollen die operativen Tätigkeiten bis zum Q2 2027 finanzieren.

Die Q3‑Finanzen zeigen einen Nettverlust von $812,7M, bedingt durch einen Verlust auf Warrants-Verbindlichkeiten und Gesamtverbindlichkeiten von $2,402B.

Vor Bio (NASDAQ: VOR) أصدرت نتائج الربع الثالث من 2025 وتحديثاً واسعاً للسريرية والشركات في 13 نوفمبر 2025. أظهرت قراءات متعددة من المرحلة الثالثة لـ telitacicept فاعلية إيجابية وسلامة مميزة عبر المؤشرات: gMG (استجابة MG‑ADL ≥3 نقاط عند 48 أسبوعاً)، مرض جويورن (ESSDAI معدل مقابل الدواء الوهمي −3.8؛ 71.8% مقابل 19.3% ≥3 نقاط ESSDAI عند 24 أسبوعاً)، LES (SLE) (67.1% مقابل 32.7% SRI‑4 معدل عند الأسبوع 52)، واعتلال المسالك IgA (خفض 55% في 24h‑UPCR عند 39 أسبوعاً). من الناحية الشركاتية: رفعت الإيرادات الإجمالية المتوقعة إلى $115 مليون في عرض نوفمبر 2025؛ وكانت النقدية والأوراق المالية القابلة للتداول $170.5M حتى 30 سبتمبر 2025، ومن المتوقع تمويل العمليات حتى الربع الثاني من 2027.

أما نتائج الربع الثالث فتكشف عن خسارة صافية قدرها $812.7M مدفوعة بخسارة على التزامات Warrants وخصوم إجمالية قدرها $2.402B.

Positive
  • Multiple Phase 3 readouts showed positive efficacy across four indications
  • SLE: modified SRI‑4 response 67.1% vs 32.7% at Week 52
  • IgAN: 55% reduction in 24h‑UPCR at 39 weeks versus placebo
  • gMG: 96.2% achieved ≥3‑point MG‑ADL improvement at 48 weeks
  • Expected gross proceeds of $115 million from November 2025 offering
  • Cash and marketable securities of $170.5 million as of Sept 30, 2025
Negative
  • Net loss of $812.7 million for Q3 2025 driven by warrant liability revaluation
  • Total liabilities of $2.402 billion and stockholders' deficit of $2.225 billion
  • Cash runway projected only into Q2 2027 despite recent financing
  • Weighted‑average shares increased to 6.68 million, diluting prior basis

Insights

Multiple positive Phase 3 readouts across indications and durable effects through 48 weeks materially advance telitacicept's clinical profile.

Telitacicept now shows consistent efficacy and tolerability across several late‑stage programs including gMG, Sjögren’s disease, SLE and IgAN, with high responder rates (e.g., 96.2% achieving ≥3‑point MG‑ADL at 48 weeks) and statistically significant primary endpoint wins reported. These outcomes provide clear, disclosable evidence of clinical activity and durability in diverse autoimmune targets, which materially raises the program’s development value as a single molecule with multi‑indication signal.

Key dependencies remain regulatory review pathways and global development alignment; the updates cite successful China Phase 3 programs and a global Phase 3 in gMG underway, but do not state regulatory filings or approvals. Watch for formal regulatory submissions, additional blinded, randomized global data readouts, and any safety signals during expanded use; near‑term milestones to monitor include upcoming global gMG trial readouts and any stated filing timelines through 20262027.

Clinical wins plus recent financing extend runway, but large warrant revaluation drove a one‑time non‑cash loss and negative equity.

Reported proceeds include an expected 115 million from the November 2025 offering and a cash, cash equivalents and marketable securities position of 170.5 million as of September 30, 2025, which management projects will fund operations into Q2 2027. Those financings materially strengthen near‑term liquidity to support ongoing global Phase 3 execution and commercial readiness hires.

However, the quarter includes a large non‑cash loss on change in fair value of warrant liabilities of 790,457 (thousands) producing a net loss of 812,684 (thousands) and a reported total liabilities balance of 2,401,724 (thousands) with negative stockholders’ equity; these are accounting outcomes tied to warrant valuation rather than cash operating burn. Monitor cash conversion from stated proceeds, actual runway updates, any further equity or debt transactions, and whether warrant or liability items recur in upcoming filings over the next 6–12 months.

Multiple Late-Stage Data Readouts Reinforce Telitacicept’s Broad Potential Across Autoimmune Diseases

Expansion of Executive Leadership and Board Strengthens Global Development Capabilities

Expected gross proceeds of $115 million raised in the November 2025 underwritten public offering, including the underwriters’ full exercise of the option to purchase additional shares

BOSTON, Nov. 13, 2025 (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, 2025, and provided a corporate update.

“This has been a pivotal quarter for Vor Bio, as we continue to redefine success in autoimmune disease. Across multiple late-stage programs, telitacicept has now demonstrated consistent results on multiple efficacy endpoints, durable benefit, and a favorable safety profile, a rare combination in our field. We are especially pleased with the recent Phase 3 results in Sjögren’s disease in China where we saw sustained efficacy and a favorable safety profile through 48 weeks, supporting a potential best-in-disease profile,” said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of Vor Bio. “With proof of concept in five autoimmune indications and a global Phase 3 clinical trial underway in generalized myasthenia gravis, we are delivering on our vision to make telitacicept the most advanced BAFF/APRIL inhibitor globally and a true pipeline-in-a-product capable of transforming care for patients with serious autoimmune conditions.”

Recent Corporate and Clinical Highlights
Telitacicept: A Potential Best-in-Class Dual BAFF/APRIL Inhibitor

Generalized Myasthenia Gravis (gMG)
In October 2025, Vor Bio and its collaborator, RemeGen Co., Ltd., announced new 48-week open-label extension (OLE) data from the Phase 3 study in China evaluating telitacicept in generalized myasthenia gravis (gMG). Results were featured in an oral presentation at the American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting (AANEM) on October 29, 2025.

  • 96.2% of patients treated with telitacicept for 48 weeks achieved ≥ 3-point improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living), with a mean reduction of 7.5 points.
  • 94.2% of patients achieved ≥ 5-point improvement in QMG (Quantitative Myasthenia Gravis), with a mean reduction of 9.8 at week 48.
  • Safety was favorable and consistent with previous studies across indications; no new safety signals were observed.
  • These results reinforce telitacicept’s potential to set a new standard for durable disease control in gMG.

Sjögren’s Disease (SD)
In October 2025, Vor Bio’s and its collaborator, RemeGen Co., Ltd, reported positive top-line Phase 3 results from the study of telitacicept in Sjögren’s disease in China. The results were also featured as a late-breaking poster presentation at the 2025 ACR Convergence Meeting on October 28, 2025.

  • Telitacicept met the primary and all secondary endpoints, with placebo adjusted 3.8 points reduction of ESSDAI and 1.52 points reduction in ESSPRI, ~71.8% of patients on 160mg achieving ≥ 3-point reduction in ESSDAI at 24 weeks versus ~19.3% on placebo.
  • The benefit was durable through 48 weeks with a favorable safety profile.
  • These results support a potential best-in-disease profile in Sjögren’s disease.

Systemic Lupus Erythematosus (SLE)
In October 2025, The New England Journal of Medicine published results from the Phase 3 trial of telitacicept in patients with systemic lupus erythematosus (SLE) in China, reinforcing its potential as a disease-modifying therapy.

  • 67.1% of patients treated with telitacicept achieved a modified SRI-4 response at Week 52, compared with 32.7% on placebo (p < 0.001).
  • Telitacicept also demonstrated improvements across multiple secondary endpoints, including higher rates of SELENA-SLEDAI reduction (70.1% vs. 40.5%), extended time to flare, and greater steroid-dose reductions.
  • The treatment was well tolerated, with a safety profile consistent with previous studies across autoimmune indications.

IgA Nephropathy (IgAN)
At the American Society of Nephrology (ASN) Kidney Week 2025, Vor Bio and its collaborator, RemeGen Co., Ltd., reported positive Phase 3 results from the study evaluating telitacicept in adults with IgA nephropathy (IgAN) in China.

  • Telitacicept achieved the primary endpoint, showing a 55% reduction in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 39 weeks compared with placebo (p < 0.0001). Treatment resulted in deep, sustained, and statistically significant reductions in proteinuria with stabilization of kidney function and a favorable safety profile.
  • Across all key secondary endpoints, telitacicept significantly:
    • Preserved kidney function (GMR of eGFR relative to baseline: –1.0% (95% CI, -3.2% to 1.2%) vs –7.7% (95% CI, -9.9% to -5.4%) for placebo,
    • Reduced the proportion of patients with a ≥ 30% decline in eGFR (6.3% vs 27.0%), and
    • 61% versus 19.5% of patients achieved 24h-UPCR <0.8 g/g, 42.1% versus 7.5% of patients achieved <0.5 g/g, and 24.5% versus 0.6% of patients achieved <0.3 g/g, thresholds linked to low risk of disease progression.
  • Adverse events were mostly mild to moderate, and serious adverse events occurred less often with telitacicept than with placebo (2.5% vs 8.2%). No unexpected safety findings were observed.

Leadership and Governance Updates

Vor Bio significantly expanded its Leadership Team and Board in the third quarter to support late-stage development and commercial readiness:

Leadership Team

  • Jeremy Sokolove, M.D. appointed Chief Medical Officer (November 2025)
  • Adi Osovsky, S.J.D. appointed General Counsel (September 2025)
  • Navid Z. Khan, Ph.D. appointed Chief Medical Affairs Officer (September 2025)
  • Dallan Murray appointed Chief Commercial Officer (August 2025)
  • Sandy Mahatme appointed Chief Financial Officer and Chief Business Officer (July 2025)
  • Qing Zuraw, M.D. appointed Chief Development Officer (July 2025)

Board of Directors

  • Alexander (Bo) Cumbo, Michel Detheux, Ph.D. and Sarah Reed joined the Board of Directors, bringing deep commercial and biopharma development expertise (July and August 2025)

Third Quarter 2025 Financial Results

  • Cash Position: Cash, cash equivalents and marketable securities were $170.5 million as of September 30, 2025, which, together with the proceeds from at-the-market sales during October 2025 and the public offering in November 2025, are projected to fund operations into the second quarter of 2027.
  • Research & Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were $14.1 million, compared to $21.8 million for the third quarter of 2024. The decrease of $7.7 million was primarily due to lower stock-based compensation and personnel costs as the Company had lower headcount following the implementation of the Restructuring Plan and reduced spend on its previous programs, trem-cel and VCAR33, partially offset by the $13.1 million increase in spend on telitacicept - gMG, as the Company began research and development activities for the new program.
  • General & Administrative (G&A) Expenses: G&A expenses for the third quarter of 2025 were $14.0 million, compared to $6.7 million for the third quarter of 2024. The increase of $7.3 million was primarily due to an increase in stock-based compensation expense.
  • Net Loss: Net loss for the third quarter of 2025 was $812.7 million, compared to $27.6 million for the third quarter of 2024. The decrease of $785.1 million was primarily due to the loss on change in fair value of the outstanding liability-classified warrants.
  
Condensed Consolidated Balance Sheet Data (Unaudited) 
(in thousands) 
      
  September 30, December 31, 
  2025
 2024
 
Cash, cash equivalents and marketable securities$170,462  $91,926  
Total assets  176,237   142,891  
Total liabilities  2,401,724   46,227  
Total stockholders' (deficit) equity  (2,225,487)  96,664  
      
Condensed Consolidated Statement of Operations (Unaudited) 
(in thousands, except share and per share data) 
      
  Three Months Ended 
  September 30, 
  2025
 2024
 
Operating expenses:     
   Research and development $14,142  $21,817  
   General and administrative  13,965   6,696  
      Total operating expenses $28,107 -$28,513  
Loss from operations $(28,107) $(28,513) 
Other income:     
Interest income  1,731   954  
Other income  4,149                        -  
Loss on warrant liabilities  (790,457)                       -  
      Total other (loss) income  (784,577)  954  
Net loss $(812,684) $(27,559) 
      
Net loss per share attributable to common stockholders, basic and diluted $(121.63) $(8.05) 
Weighted-average common shares outstanding, basic and diluted  6,681,794   3,423,499  
      

About Telitacicept
Telitacicept is a novel, investigational recombinant fusion protein designed to treat autoimmune diseases by selectively inhibiting 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), and generalized myasthenia gravis (gMG). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, South America, and Asia-Pacific to support potential approval 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.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “aim,” “anticipate,” “can,” “continue,” “could,” “design,” “enable,” “expect,” “initiate,” “intend,” “may,” “on-track,” “ongoing,” “plan,” “potential,” “should,” “target,” “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 the potential of telitacicept to be disease-modifying; the potential of telitacicept in Sjögren’s disease to have a best-in-class profile; Vor Bio’s vision to make telitacicept the most advanced BAFF/APRIL inhibitor globally and a true pipeline-in-a-product capable of transforming care for patients with serious autoimmune conditions; Vor Bio’s expected proceeds from the November 2025 public offering; Vor Bio’s projected cash runway; Vor Bio’s development and commercialization plans for telitacicept; 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 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. 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. The results of the clinical trial described in this press release is based on information reported by RemeGen; Vor Bio has not independently verified this data. 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.

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

Sarah Spencer
investors@vorbio.com


FAQ

What did Vor Bio (VOR) announce about telitacicept Phase 3 results on November 13, 2025?

Vor Bio reported positive Phase 3 readouts across gMG, Sjögren’s disease, SLE, and IgA nephropathy with efficacy and favorable safety profiles.

How much cash did Vor Bio (VOR) report on its balance sheet as of September 30, 2025?

Vor Bio reported $170.5 million in cash, cash equivalents, and marketable securities as of September 30, 2025.

What caused Vor Bio's (VOR) $812.7M net loss in Q3 2025?

The Q3 2025 net loss of $812.7M was primarily due to a loss on change in fair value of outstanding liability‑classified warrants.

How much gross proceeds did Vor Bio (VOR) expect from its November 2025 public offering?

Vor Bio expected gross proceeds of $115 million from the November 2025 underwritten public offering, including full exercise of the option.

What were the key efficacy numbers for telitacicept in Sjögren’s disease reported in Q3/Q4 2025?

Telitacicept showed a placebo‑adjusted ESSDAI reduction of 3.8 points and ~71.8% of patients on 160mg achieved ≥3‑point ESSDAI at 24 weeks versus ~19.3% on placebo.

Does Vor Bio (VOR) have a funding runway and how long is it expected to last?

Company guidance projects existing cash, ATM proceeds in October 2025, and the November 2025 offering proceeds to fund operations into Q2 2027.

How did telitacicept perform in the SLE Phase 3 trial published in NEJM?

In SLE, telitacicept achieved a modified SRI‑4 response in 67.1% of patients versus 32.7% for placebo at Week 52 (p < 0.001).
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Biotechnology
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