Zenas BioPharma Reports Second Quarter 2025 Financial Results and Provides Corporate Updates
Zenas BioPharma (NASDAQ:ZBIO) has reported its Q2 2025 financial results and provided updates on its clinical programs. The company ended Q2 with $274.9 million in cash and investments, providing runway into Q4 2026.
Key clinical developments include: expected topline results from the Phase 3 INDIGO trial in IgG4-Related Disease by year-end 2025, completed enrollment in the Phase 2 MoonStone trial for Relapsing Multiple Sclerosis with results expected in early Q4 2025, and ongoing enrollment in the Phase 2 SunStone trial for Systemic Lupus Erythematosus with completion expected by year-end 2025.
Financial results show R&D expenses increased to $43.0 million from $33.8 million year-over-year, while G&A expenses rose to $12.1 million from $5.9 million. Net loss widened to $52.2 million compared to $38.0 million in Q2 2024.
Zenas BioPharma (NASDAQ:ZBIO) ha comunicato i risultati finanziari del secondo trimestre 2025 e aggiornato i suoi programmi clinici. La società ha chiuso il Q2 con 274,9 milioni di dollari in liquidità e investimenti, garantendo copertura finanziaria fino al quarto trimestre 2026.
Sul fronte clinico, i principali sviluppi includono: i risultati topline attesi per il trial di Fase 3 INDIGO nella malattia correlata alle IgG4 entro la fine del 2025, il completamento dell'arruolamento nel trial di Fase 2 MoonStone per la sclerosi multipla recidivante con risultati previsti all'inizio del Q4 2025, e l'arruolamento in corso nel trial di Fase 2 SunStone per il lupus eritematoso sistemico, con conclusione prevista entro fine 2025.
I conti mostrano che le spese per R&S sono salite a 43,0 milioni di dollari rispetto a 33,8 milioni su base annua, mentre le spese G&A sono aumentate a 12,1 milioni di dollari da 5,9 milioni. La perdita netta si è ampliata a 52,2 milioni di dollari rispetto a 38,0 milioni nel Q2 2024.
Zenas BioPharma (NASDAQ:ZBIO) presentó sus resultados financieros del segundo trimestre de 2025 y actualizaciones sobre sus programas clínicos. La compañía cerró el Q2 con 274,9 millones de dólares en efectivo e inversiones, asegurando liquidez hasta el cuarto trimestre de 2026.
Entre los avances clínicos clave se incluyen: resultados topline esperados del ensayo de Fase 3 INDIGO en enfermedad relacionada con IgG4 antes de fin de 2025, finalización del reclutamiento en el ensayo de Fase 2 MoonStone para esclerosis múltiple recurrente con resultados previstos a principios del Q4 2025, y reclutamiento en curso en el ensayo de Fase 2 SunStone para lupus eritematoso sistémico con cierre previsto a final de 2025.
En lo financiero, los gastos de I+D aumentaron a 43,0 millones de dólares desde 33,8 millones interanuales, mientras que los gastos generales y administrativos subieron a 12,1 millones de dólares desde 5,9 millones. La pérdida neta se amplió a 52,2 millones de dólares frente a 38,0 millones en el Q2 2024.
Zenas BioPharma (NASDAQ:ZBIO)는 2025년 2분기 실적을 공시하고 임상 프로그램 관련 업데이트를 제공했습니다. 회사는 2분기 말 현재 현금 및 투자총액 $274.9 million을 보유해 2026년 4분기까지 자금 여력을 확보했습니다.
주요 임상 업데이트는 다음과 같습니다: IgG4 관련 질환을 대상으로 한 Phase 3 INDIGO 임상의 톱라인 결과가 2025년 연말까지 예정되어 있고, 재발성 다발성 경화증을 대상으로 한 Phase 2 MoonStone 임상은 모집을 완료했으며 결과는 2025년 4분기 초에 예상됩니다. 전신 홍반성 루푸스를 대상으로 한 Phase 2 SunStone 임상은 현재 모집 중이며 연말까지 완료될 것으로 예상됩니다.
재무적으로 연구개발비(R&D)는 전년 동기 대비 $33.8 million에서 $43.0 million으로 증가했고, 일반관리비(G&A)는 $5.9 million에서 $12.1 million으로 상승했습니다. 순손실은 Q2 2024의 $38.0 million에서 $52.2 million으로 확대되었습니다.
Zenas BioPharma (NASDAQ:ZBIO) a publié ses résultats financiers du deuxième trimestre 2025 et fourni des mises à jour sur ses programmes cliniques. La société a clôturé le T2 avec 274,9 millions de dollars en liquidités et investissements, assurant une visibilité financière jusqu'au quatrième trimestre 2026.
Parmi les avancées cliniques clés : des résultats topline attendus pour l'essai de phase 3 INDIGO dans la maladie liée aux IgG4 d'ici la fin de 2025, le recrutement terminé pour l'essai de phase 2 MoonStone dans la sclérose en plaques récurrente avec des résultats prévus début du T4 2025, et le recrutement en cours pour l'essai de phase 2 SunStone dans le lupus érythémateux systémique, dont l'achèvement est attendu d'ici la fin 2025.
Sur le plan financier, les dépenses R&D ont augmenté à 43,0 millions de dollars contre 33,8 millions en glissement annuel, tandis que les frais G&A sont passés à 12,1 millions de dollars contre 5,9 millions. La perte nette s'est creusée à 52,2 millions de dollars contre 38,0 millions au T2 2024.
Zenas BioPharma (NASDAQ:ZBIO) hat seine Finanzergebnisse für das zweite Quartal 2025 veröffentlicht und Updates zu seinen klinischen Programmen gegeben. Das Unternehmen beendete Q2 mit 274,9 Millionen US-Dollar an Zahlungsmitteln und Anlagen, was eine Finanzreichweite bis ins vierte Quartal 2026 ermöglicht.
Zu den wichtigsten klinischen Entwicklungen zählen: Topline‑Ergebnisse der Phase‑3‑Studie INDIGO bei IgG4‑assoziierter Erkrankung werden bis Ende 2025 erwartet, die Rekrutierung für die Phase‑2‑Studie MoonStone bei rezidivierender Multipler Sklerose ist abgeschlossen (Ergebnisse voraussichtlich Anfang Q4 2025), und die Rekrutierung in der Phase‑2‑Studie SunStone bei systemischem Lupus erythematodes läuft und soll bis Jahresende 2025 abgeschlossen sein.
Finanziell stiegen die F&E‑Aufwendungen von 33,8 Mio. USD auf 43,0 Mio. USD, während die Verwaltungs‑ und Gemeinkosten von 5,9 Mio. USD auf 12,1 Mio. USD zunahmen. Der Nettoverlust weitete sich auf 52,2 Mio. USD aus gegenüber 38,0 Mio. USD im Q2 2024.
- Strong cash position of $274.9 million providing runway into Q4 2026
- Completed enrollment in Phase 2 MoonStone trial for Multiple Sclerosis
- Advanced largest clinical trial to date in IgG4-RD with Phase 3 INDIGO study
- Multiple clinical readouts expected between Q4 2025 and mid-2026
- Net loss increased 37% year-over-year to $52.2 million
- R&D expenses increased 27% to $43.0 million
- G&A expenses more than doubled to $12.1 million
Insights
Zenas reports mixed Q2 results with increasing losses, but maintains strong cash position while advancing multiple late-stage autoimmune disease trials.
Zenas BioPharma's Q2 financial results reveal a 37% increase in net loss to
Despite the accelerating cash burn, Zenas maintains a healthy cash position of
- Phase 3 INDIGO trial in IgG4-Related Disease with results expected around year-end 2025
- Completed enrollment in Phase 2 MoonStone trial for Relapsing Multiple Sclerosis with data expected early Q4 2025
- Ongoing Phase 2 SunStone trial in Systemic Lupus Erythematosus with enrollment completion targeted by year-end 2025
The market should pay close attention to the upcoming readouts, particularly the Phase 3 INDIGO results, which could potentially validate Zenas's platform and provide a clear path to commercialization. The company's strategic focus on multiple autoimmune indications with a single compound demonstrates efficient capital allocation while creating multiple shots on goal. If successful, obexelimab's novel mechanism targeting B cell function could address significant unmet needs across these difficult-to-treat autoimmune conditions.
Obexelimab's unique CD19xFcγRIIb mechanism shows promise across multiple autoimmune diseases with key readouts approaching.
Zenas's lead candidate obexelimab represents a differentiated approach to autoimmune disease treatment through its dual-targeting mechanism that inhibits B cell function via CD19 and FcγRIIb interaction. This approach is particularly compelling as it targets a fundamental immunological pathway involved in multiple autoimmune conditions rather than focusing on disease-specific symptoms.
The INDIGO trial in IgG4-Related Disease (IgG4-RD) is especially significant as it represents the largest clinical study ever conducted for this rare inflammatory condition characterized by tissue fibrosis and organ dysfunction. Current IgG4-RD treatments primarily rely on broad immunosuppression with glucocorticoids, which carry substantial side effects with long-term use. A targeted therapy like obexelimab could transform the treatment paradigm if effective.
The company's expansion into Relapsing Multiple Sclerosis (RMS) and Systemic Lupus Erythematosus (SLE) demonstrates scientific confidence in obexelimab's mechanism. For RMS, where B cells play a crucial role in disease pathogenesis, the MoonStone trial's primary endpoint at 12 weeks suggests the company is measuring early inflammatory markers or MRI lesions. For SLE, a notoriously difficult indication with numerous clinical trial failures, obexelimab's targeted approach may overcome challenges that have hindered previous drug development efforts.
The staggered timing of trial readouts (RMS in early Q4 2025, IgG4-RD around year-end 2025, and SLE in mid-2026) creates a strategic sequence of catalysts that could progressively validate obexelimab's mechanism across multiple conditions. If successful in these diverse autoimmune diseases, obexelimab could establish itself as a platform therapy with broad applications throughout autoimmune medicine.
- Topline results from pivotal Phase 3 INDIGO trial in Immunoglobulin G4-Related Disease expected around year-end 2025 -
- Completed enrollment of Phase 2 MoonStone trial in Relapsing Multiple Sclerosis; results expected early in the fourth quarter 2025 -
- Enrollment of Phase 2 SunStone trial in Systemic Lupus Erythematosus expected to be completed by year-end 2025; topline results expected mid-2026 -
- Cash, cash equivalents and investments of
WALTHAM, Mass., Aug. 12, 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 transformative therapies for autoimmune diseases, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate updates.
“We are very pleased with the rapid advancement of our broad obexelimab development program, including the completion of enrollment for the Phase 2 MoonStone trial in patients with Relapsing Multiple Sclerosis this past quarter. We look forward to reporting the results from the primary analysis of the trial, and importantly, the topline results from the Phase 3 INDIGO trial of obexelimab in patients with IgG4-RD,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “Given the differentiated profile of obexelimab, along with our extensive development capabilities and commercialization experience, we are well positioned to execute on the significant opportunity ahead to potentially impact the lives of patients living with autoimmune diseases worldwide.”
Recent corporate highlights
Obexelimab, a CD-19 x FcγRIIb inhibitor of B cell function
- Immunoglobulin G4-Related Disease (IgG4-RD): Advanced the Phase 3 INDIGO trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with IgG4-RD. INDIGO is the largest clinical trial conducted in patients living with IgG4-RD to date. Target enrollment of the INDIGO trial concluded in November 2024, and Zenas expects to report topline results around year-end 2025.
- Relapsing Multiple Sclerosis (RMS): Completed enrollment of the Phase 2 MoonStone trial, a multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with RMS. Zenas expects to report results from this trial, including the 12-week primary endpoint results, early in the fourth quarter of 2025.
- Systemic Lupus Erythematosus (SLE): Continued enrollment of the Phase 2 SunStone trial, a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of obexelimab in patients with SLE. Zenas expects to complete enrollment of the Phase 2 SunStone trial by year-end 2025 and report topline results in mid-2026.
Second quarter 2025 financial results
- As of June 30, 2025, the Company’s cash, cash equivalents and investments were
$274.9 million . The Company expects that its cash, cash equivalents and investments, as of June 30, 2025, will fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026. - Research and development (R&D) expenses were
$43.0 million for the quarter ended June 30, 2025, compared to$33.8 million for the quarter ended June 30, 2024. The increase of$9.2 million in R&D expenses primarily relates to an increase in costs related to the clinical development of obexelimab and an increase in personnel costs partially offset by a decrease in costs related to our partnered programs. - General and administrative (G&A) expenses were
$12.1 million for the quarter ended June 30, 2025, compared to$5.9 million for the quarter ended June 30, 2024. The increase of$6.2 million in G&A expenses was due to an increase in personnel costs, including stock-based compensation expense, pre-commercialization activities including hiring and other expenses associated with operating as a public company. - Net loss was
$52.2 million for the quarter ended June 30, 2025, compared to net loss of$38.0 million for the quarter ended June 30, 2024.
About 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 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 subjects who received obexelimab either as an intravenous infusion or as a subcutaneous injection. Obexelimab was well tolerated and demonstrated pharmacologic 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. Currently, Zenas is conducting multiple Phase 2 and Phase 3 trials of obexelimab in several autoimmune diseases including Immunoglobulin G4-Related Disease, Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus.
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.
Forward looking statements
This press release contains “forward-looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning the timing and results of ongoing and future clinical trials, including expectations on the timing of reporting INDIGO trial topline results, results of the 12-week primary endpoint analysis for the MoonStone trial and the anticipated timing of completing enrollment and reporting topline results for the SunStone trial; the ability to potentially impact the treatment of autoimmune diseases; its growth strategy; and cash runway guidance. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; significant political, trade, regulatory developments, including changes in relations between the U.S. and China; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, which is located in China; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain, speak only as of the date of this press release and may prove incorrect. These statements are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, these forward-looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
The Zenas BioPharma word mark, logo mark, and the “lightning bolt” design are trademarks of Zenas BioPharma, Inc. or its affiliated companies.
| Zenas BioPharma, Inc. | |||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
| (in thousands except share and per share amounts) | |||||||||
| Unaudited | |||||||||
| Three Months Ended | |||||||||
| June 30, | |||||||||
| 2025 | 2024 | ||||||||
| Revenue: | |||||||||
| License and collaboration revenue | $ | — | $ | — | |||||
| Total revenue | — | — | |||||||
| Operating expenses: | |||||||||
| Research and development | 43,027 | 33,807 | |||||||
| General and administrative | 12,136 | 5,895 | |||||||
| Total operating expenses | 55,163 | 39,702 | |||||||
| Loss from operations | (55,163 | ) | (39,702 | ) | |||||
| Other income, net: | |||||||||
| Other income, net | 2,960 | 1,725 | |||||||
| Total other income, net | 2,960 | 1,725 | |||||||
| Income tax (provision) benefit | (20 | ) | — | ||||||
| Net loss to common stockholders | $ | (52,223 | ) | $ | (37,977 | ) | |||
| Net loss per share attributable to common stockholders - basic and diluted | $ | (1.25 | ) | $ | (24.23 | ) | |||
| Weighted-average common stock outstanding - basic and diluted | 41,865,400 | 1,567,269 | |||||||
| Zenas BioPharma, Inc. | ||||
| SELECTED CONSOLIDATED BALANCE SHEET DATA | ||||
| (in thousands) | ||||
| Unaudited | ||||
| June 30 | ||||
| 2025 | ||||
| Cash, cash equivalents and investments | $ | 274,893 | ||
| Working capital | 225,359 | |||
| Total assets | 293,085 | |||
| Accumulated deficit | (473,187 | ) | ||
| Total stockholders’ equity | 239,626 | |||
Investor and Media Contact:
Argot Partners
Zenas@argotpartners.com
FAQ
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