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Jade Biosciences Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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Jade Biosciences (Nasdaq: JBIO) reported Q3 2025 results and a corporate update on Nov 13, 2025 highlighting clinical advances and financing.

Key points: presented favorable preclinical safety and translational biomarker data for JADE101 at ASN Kidney Week; initiated a Phase 1 healthy volunteer study with interim biomarker-rich data expected in H1 2026; unveiled JADE201, an afucosylated anti-BAFF-R candidate with first-in-human RA trial planned in H1 2026; completed a $135 million private placement and reported pro forma cash of approximately $325.6 million, funding operations into the first half of 2028.

Jade Biosciences (Nasdaq: JBIO) ha riportato i risultati del terzo trimestre 2025 e un aggiornamento aziendale il 13 novembre 2025, evidenziando progressi clinici e attività di finanziamento.

Punti chiave: sono stati presentati dati preclinici di sicurezza favorevoli e biomarcatori di traslazione per JADE101 all'ASN Kidney Week; è stato avviato uno studio di Fase 1 su volontari sani con dati interni ricchi di biomarcatori previsti nell'H1 2026; è stato presentato JADE201, un candidato afucosilato anti-BAFF-R con uno studio nell'uomo per l'AR pianificato nell'H1 2026; è stato completato un collocamento privato da $135 milioni e riportata una cassa pro forma di circa $325,6 milioni, finanziando le operazioni fino alla prima metà del 2028.

Jade Biosciences (Nasdaq: JBIO) informó resultados del tercer trimestre de 2025 y una actualización corporativa el 13 de noviembre de 2025, destacando avances clínicos y financiamiento.

Puntos clave: se presentaron datos de seguridad preclínica favorables y biomarcadores traslacionales para JADE101 en ASN Kidney Week; se inició un estudio de Fase 1 en voluntarios sanos con datos intermedios ricos en biomarcadores esperados en H1 2026; se presentó JADE201, un candidato anti-BAFF-R afucosilado con un ensayo en humanos para AR planificado para H1 2026; se completó una colocación privada de $135 millones y se reportó una caja pro forma de aproximadamente $325,6 millones, financiando las operaciones hasta la primera mitad de 2028.

Jade Biosciences (Nasdaq: JBIO)는 2025년 11월 13일 3분기 실적 발표 및 기업 업데이트를 발표하며 임상 진전과 자금 조달을 강조했습니다.

핵심 요지: JADE101에 대한 우수한 전임상 안전성 및 바이오마커 데이터를 ASN Kidney Week에서 제시했습니다; H1 2026에 예정된 인터로 바이오마커가 풍부한 데이터를 포함한 건강한 지원자 대상 Fase 1 연구를 시작했습니다; JADE201, BAFF-R에 대한 포스페실화된 항-BAFF-R 후보물질로 RA의 최초 인간 임상시험이 H1 2026에 계획되어 있습니다; $135 million의 비공개 배정이 완료되었고 약 $325.6 million의 프리모 달러 현금이 보고되어 2028년 상반기까지 운영을 자금조달합니다.

Jade Biosciences (Nasdaq: JBIO) a publié les résultats du T3 2025 et une mise à jour d'entreprise le 13 novembre 2025, mettant en évidence les progrès cliniques et le financement.

Points clés: des données précliniques de sécurité favorable et des biomarqueurs translationnels pour JADE101 ont été présentés à la ASN Kidney Week; démarrage d'une étude de Phase 1 chez des volontaires sains avec des données biomarqueurs intermédiaires attendues au H1 2026; dévoilement de JADE201, un candidat afucosylé anti-BAFF-R avec un essai chez l'homme pour le RA prévu au H1 2026; placement privé de $135 millions effectué et trésorerie pro forma d'environ $325,6 millions, finançant les opérations jusqu'au premier semestre de 2028.

Jade Biosciences (Nasdaq: JBIO) meldete am 13. November 2025 die Ergebnisse für das Q3 2025 und ein Unternehmensupdate und hob klinische Fortschritte sowie die Finanzierung hervor.

Kernpunkte: Positive präklinische Sicherheitsdaten und translational Biomarker-Daten für JADE101 wurden beim ASN Kidney Week vorgestellt; mit H1 2026 wurde eine Phase-1-Studie an gesunden Freiwilligen gestartet, bei der Zwischenbiomarker-Daten erwartet werden; JADE201, ein afucosilierter Anti-BAFF-R-Kandidat mit der ersten In-human-RA-Studie, die für H1 2026 geplant ist; ein privates Placement in Höhe von $135 Millionen abgeschlossen und eine Pro-Forma-Cash von ca. $325,6 Millionen berichtet, wodurch die Operationen bis zur ersten Hälfte von 2028 finanziert werden.

Jade Biosciences (Nasdaq: JBIO) أبلغت عن نتائج الربع الثالث من 2025 وتحديثاً للشركة في 13 نوفمبر 2025، مع إبراز التقدمات السريرية والتمويل.

النقاط الرئيسية: تم عرض بيانات أمان حيوي ما قبل السريرية ومؤشرات حيوية ترجمانية لـ JADE101 في ASN Kidney Week؛ تم البدء في دراسة من المرحلة 1 في متطوعين أصحاء مع بيانات وسطية غنية بمؤشرات حيوية متوقعة في H1 2026؛ كشف عن JADE201، مرشح afucosylated مضاد BAFF-R مع تجربة في البشر لـ RA مخطط لها في H1 2026؛ إغلاق تخصيص خاص بقيمة $135 ملايين وأبلغ عن نقدية طويلة الأجل حوالي $325.6 مليون، مما يمول العمليات حتى النصف الأول من 2028.

Positive
  • Completed $135 million private placement
  • Pro forma cash position of approximately $325.6 million
  • Cash runway funded into the first half of 2028
  • Initiated Phase 1 healthy-volunteer study of JADE101
  • Interim biomarker-rich data expected in H1 2026
  • First-in-human trial for JADE201 planned in H1 2026
  • JADE101 showed NOAEL and no off-target binding in NHP studies
Negative
  • R&D expense increased to $22.0M in Q3 2025 (from $13.6M)
  • G&A expense increased to $5.4M in Q3 2025 (from $1.4M)
  • Net loss widened to $25.2M in Q3 2025 (from $16.3M)

Insights

Jade advanced clinical programs and secured financing, strengthening runway and de‑risking near‑term biomarker readouts.

Jade progressed two preclinical/early clinical assets: JADE101 (selective anti‑APRIL) entered a Phase 1 healthy volunteer study with interim, biomarker‑rich data expected in the first half of 2026, and JADE201 (afucosylated anti‑BAFF‑R) is slated for a first‑in‑human rheumatoid arthritis trial in the first half of 2026. These programs use biomarker‑driven dose selection and half‑life extension to target less frequent subcutaneous dosing, which could improve patient convenience and competitive positioning if clinical pharmacology translates to patients.

The company’s cash position improved materially via a completed private placement and a pro‑forma $325.6 million balance, giving runway into the first half of 2028. Key dependencies include whether JADE101’s healthy volunteer biomarker responses robustly predict clinical benefit in IgA nephropathy and whether JADE201’s enhanced half‑life and afucosylation translate to differentiated efficacy or safety versus existing BAFF‑R approaches. R&D spending increased to $22.0 million this quarter, contributing to a larger net loss of $25.2 million, which is consistent with active development but will consume cash over time.

Watch for the interim JADE101 biomarker readout in the first half of 2026 and the start of JADE201’s first‑in‑human trial in the same window; both are near‑term, de‑risking milestones. Also monitor subsequent patient‑level efficacy links between APRIL suppression and reductions in IgA, Gd‑IgA1, and proteinuria, and quarterly cash burn vs. guidance to confirm the stated runway into first half of 2028.

  • Presented favorable preclinical safety data for JADE101 and a translational analysis of APRIL mediated biomarker responses at the American Society of Nephrology Kidney Week 2025, reinforcing its potential as a best-in-class selective anti-APRIL monoclonal antibody for IgA nephropathy
  • Initiated Phase 1 healthy volunteer study of JADE101; interim, biomarker-rich data expected in the first half of 2026 are anticipated to define dose and dose interval selection for patient trials
  • Unveiled JADE201, a potentially best-in-class, half-life extended, afucosylated anti-BAFF receptor monoclonal antibody; first-in-human trial in rheumatoid arthritis expected to begin in the first half of 2026 with potential opportunity across multiple autoimmune diseases validated by BAFF-R biology
  • Completed $135 million private placement, extending cash runway into the first half of 2028

SAN FRANCISCO and VANCOUVER, British Columbia, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Jade Biosciences, Inc. (“Jade”) (Nasdaq: JBIO), a biotechnology company focused on developing best-in-class therapies for autoimmune diseases, today announced financial results for the quarter ending September 30, 2025, and provided a corporate update.

“The third quarter marked meaningful progress toward our mission of delivering potentially best-in-class therapies for autoimmune diseases,” said Tom Frohlich, Chief Executive Officer of Jade Biosciences. “At the recent ASN Kidney Week, we presented preclinical safety and translational data that support JADE101’s potential to be a best-in-class, selective anti-APRIL therapy and provide further confidence that biomarker data from our ongoing Phase 1 healthy volunteer trial will define the dosing strategy for IgAN patient studies. We also introduced our second development candidate, JADE201, which builds on validated BAFF-R biology to potentially address a broad range of autoimmune diseases, and completed a $135 million private financing. With these achievements, we are well positioned to execute on multiple clinical milestones and bring further innovation in autoimmune disease treatment.”

Pipeline and Corporate Updates

JADE101: potentially best-in-class selective anti-APRIL monoclonal antibody for IgA nephropathy (IgAN)

  • Presented two posters at the American Society of Nephrology (ASN) Kidney Week 2025. JADE101 is an ultra-high affinity, half-life-extended fully human monoclonal antibody that has the potential for best-in-class activity with convenient patient dosing. JADE101 is an ultra-high affinity, half-life-extended fully human monoclonal antibody that has the potential for best-in-class activity with convenient patient dosing.
    • In a poster presentation of non-clinical safety data, JADE101 was well tolerated in NHPs at all doses tested preclinically, including at the highest dose establishing the no-observed-adverse-effect level (NOAEL), supporting the first-in-human doses being evaluated in the ongoing Phase 1 trial. JADE101 showed no off-target binding, tissue cross-reactivity, or cytokine release and produced reversible, mechanism-consistent reductions in serum immunoglobulins (IgA, IgM, IgG) without evidence of broad immune suppression, reinforcing its potential as a well-tolerated and selective therapy.
    • A second poster presentation described a translational assessment demonstrating consistency of biomarker responses to APRIL inhibition across NHPs, healthy volunteers and IgAN patients, showing that pharmacokinetic and biomarker responses observed in healthy volunteers are predictive of anticipated therapeutic outcomes in IgAN patients. These analyses link the depth and duration of APRIL suppression to expected reductions in IgA, Gd-IgA1, and proteinuria associated with kidney function preservation, supporting that biomarker data from the ongoing Phase 1 study will define dose and dosing interval selection for IgAN patient trials and enable convenient, infrequent subcutaneous dosing.
  • Initiated enrollment in Phase 1 clinical trial evaluating JADE101 administered as a subcutaneous injection in healthy volunteers.
    • Interim, biomarker-rich data are expected in the first half of 2026 and are anticipated to define the dose and dose interval for Phase 2 and Phase 3 clinical trials.

JADE201: potentially best-in-class anti-BAFF-R monoclonal antibody for autoimmune diseases

  • Introduced JADE201, a half-life extended, afucosylated monoclonal antibody targeting the B-cell activating factor receptor (BAFF-R).
    • JADE201 is designed to overcome the limitations of current B cell-directed therapies by combining a dual mechanism of action and half-life extension technology, with the goal of improving on the clinical benefit of existing B-cell depleting therapies across a broad range of autoimmune diseases with less frequent subcutaneous dosing.
    • JADE201 builds on the clinical proof-of-concept for BAFF-R targeting established by ianalumab, which met primary endpoints in recent Phase 3 Sjogren’s and idiopathic thrombocytopenic purpura trials.
    • In NHP studies, JADE201 showed high-affinity BAFF-R binding, achieved dose-dependent BAFF receptor occupancy, sustained B-cell depletion, and demonstrated an approximately two-fold extended half-life versus ianalumab.
    • A first-in-human trial evaluating JADE201 in rheumatoid arthritis is expected to begin in the first half of 2026, with potential for broad opportunity across multiple autoimmune diseases validated by BAFF-R biology.

Corporate

Third Quarter 2025 Financial Results

  • Cash Position: As of September 30, 2025, Jade had cash, cash equivalents, and investments of $198.9 million. In October, the Company closed on a $135 million private placement financing, resulting in cash, cash equivalents, and investments of approximately $325.6 million on a pro-forma basis as of September 30, 2025. Based on its current operating plans, Jade believes that its existing cash will enable it to fund its operating expenses and capital expenditure requirements into the first half of 2028.
  • Research and Development (R&D) expenses: R&D expenses totaled $22.0 million for the third quarter ended September 30, 2025, compared to $13.6 million for the quarter ended September 30, 2024. R&D expenses increased primarily due to higher personnel-related costs as the Company builds out the internal R&D function as well as increased costs around CMC and early clinical activity.
  • General and Administrative (G&A) expenses: G&A expenses totaled $5.4 million for the third quarter ended September 30, 2025, compared to $1.4 million for the quarter ended September 30, 2024. G&A expenses increased primarily due to higher personnel-related costs as the Company builds out its internal infrastructure.
  • Net loss: Net loss totaled $25.2 million for the third quarter ended September 30, 2025, compared to a net loss of $16.3 million for the quarter ended September 30, 2024. Net loss increased primarily as a result of higher R&D and G&A expenses, as described above.
  • Shares Outstanding: After giving effect to the Company’s recently completed $135 million private placement, Jade had 67,394,380 million shares of the Company’s common stock and common stock equivalents issued and outstanding, including shares of common stock underlying pre-funded warrants and non-voting convertible preferred.

About Jade Biosciences, Inc.

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE-003, an undisclosed antibody discovery program, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn.

Forward-Looking Statements

Certain statements in this communication, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the “safe harbor” provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Jade’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Jade’s ability to achieve the expected benefits or opportunities with respect to JADE101, JADE201 and JADE-003, the expected timelines for interim data from the Phase 1 clinical trial of JADE101 and for JADE201 entering the clinic, plans for future clinical trials, the potential of Jade’s product candidates to become best-in-class therapies, their potential therapeutic uses, efficacy, safety profiles, and dosing, and the potential for Jade’s cash runway to extend into the first half of 2028. The words “opportunity,” “potential,” “milestones,” “pipeline,” “can,” “goal,” “strategy,” “target,” “anticipate,” “achieve,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “possible,” “project,” “should,” “will,” “would” and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Jade will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Jade’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the Phase 1 clinical trial of JADE101, the planned trial of JADE201 and any future clinical trials may be delayed or may not demonstrate desirable efficacy; adverse events and safety signals may occur; Jade may experience unanticipated costs, difficulties or delays in the product development process; Jade’s product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; enrollment or regulatory challenges; risks associated with Jade’s dependence on third-party vendors for the development, manufacture and supply of its product candidates; and the other risks, uncertainties and factors more fully described in Jade’s most recent filings with the Securities and Exchange Commission (including the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025). Should one or more of these risks or uncertainties materialize, or should any of Jade’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. You should not place undue reliance on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Jade does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This communication does not purport to summarize all of the conditions, risks and other attributes of an investment in Jade.

Jade Biosciences Contact

Priyanka Shah
Media@JadeBiosciences.com
IR@JadeBiosciences.com
908-447-6134

JADE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share amounts)
     
  September 30, 2025 December 31, 2024
Cash, cash equivalents and investments $198,905  $69,386 
Other assets  3,545   3,413 
Total assets $202,450  $72,799 
     
Total liabilities $23,104  $119,596 
Total stockholders' equity (deficit)  179,346   (46,799)
Total liabilities, Series Seed convertible preferred stock and stockholders' equity (deficit) $202,450  $72,799 


JADE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
         
  Three Months Ended September 30, 2025 Three Months Ended September 30, 2024 Nine Months Ended September 30, 2025 Period from June 18, 2024 (Inception) Through September 30, 2024
Operating expenses:        
Research and development(1) $22,010  $13,581  $64,580  $13,659 
General and administrative(2)  5,391   1,384   13,983   1,896 
Total operating expenses  27,401   14,965   78,563   15,555 
Loss from operations  (27,401)  (14,965)  (78,563)  (15,555)
Other income (expense):        
Interest income  2,254   388   4,697   388 
Change in fair value of Convertible Notes payable(3)     (1,700)  (21,584)  (1,700)
Other expense  (28)     (28)   
Total other income (expense), net  2,226   (1,312)  (16,915)  (1,312)
Net loss  (25,175)  (16,277)  (95,478)  (16,867)
Other comprehensive loss:         
Currency translation adjustment  18      (6)   
Unrealized gain on investments  35      35    
Comprehensive loss $(25,122) $(16,277) $(95,449) $16,867 
Net loss per share attributable to common stockholders, basic and diluted $(0.48) $(5.16) $(3.08) $(5.35)
Net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted $(482.25) $  $(3,081.78) $ 
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted  39,584,489   3,155,500   23,816,586   3,155,500 
Weighted-average shares used in computing net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted  12,622      7,166    
         
(1) Includes related party amounts of $5.8 million and $17.5 million for the three and nine months ended September 30, 2025, respectively, and $13.1 million for the three months ended September 30, 2024 and $13.2 million for the period from June 18, 2024 (inception) through September 30, 2024.
(2) Includes related party amounts of $0.2 million for both the three and nine months ended September 30, 2025, and $0.4 million for the three months ended September 30, 2024 and $0.9 million for the period from June 18, 2024 (inception) through September 30, 2024.
(3) Includes related party amounts of $4.6 million for the nine months ended September 30, 2025, and none for the three months ended September 30, 2025. Includes related party amounts of $0.4 million for the period from June 18, 2024 (inception) through September 30, 2024.

FAQ

What cash balance did JBIO report pro forma after the $135M private placement?

Jade reported a pro forma cash, cash equivalents, and investments balance of approximately $325.6 million.

How long does JBIO say its cash will fund operations after the financing?

Jade expects existing cash to fund operations into the first half of 2028 based on current operating plans.

When will JBIO report interim biomarker data from the JADE101 Phase 1 study?

Interim, biomarker-rich data from the JADE101 healthy volunteer Phase 1 study are expected in H1 2026.

What clinical program will JBIO begin for JADE201 and when?

JBIO plans a first-in-human trial of JADE201 in rheumatoid arthritis beginning in H1 2026.

What preclinical safety findings did JBIO present for JADE101 at ASN Kidney Week 2025?

JADE101 was reportedly well tolerated in non-human primates with a defined NOAEL, no off-target binding, and no cytokine release.

How did JBIO's operating expenses change in Q3 2025 versus Q3 2024?

R&D rose to $22.0M from $13.6M and G&A rose to $5.4M from $1.4M year-over-year.

What was JBIO's net loss in Q3 2025?

Net loss for the quarter ended September 30, 2025 was $25.2 million.
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