MBX Biosciences Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights
MBX Biosciences (Nasdaq: MBX) reported positive Phase 2 topline results for once-weekly canvuparatide in hypoparathyroidism, with 63% responder rate at 12 weeks and 79% at six months in the open-label extension.
The company completed an upsized public offering raising approximately $200 million and reported $391.7 million in cash, cash equivalents and marketable securities as of September 30, 2025, which management expects will fund operations into 2029. MBX highlighted planned regulatory interactions in Q1 2026 and a Phase 3 start in Q3 2026, plus ongoing MBX 4291 and imapextide trials with key readouts in 2026.
MBX Biosciences (Nasdaq: MBX) ha riportato risultati positivi di fase 2 topline per canvuparatide somministrato una volta alla settimana per l'ipoparatiroidismo, con 63% di responder a 12 settimane e 79% a sei mesi nell'estensione in aperto.
L'azienda ha completato un'offerta pubblica upsized che ha raccolto circa $200 milioni e ha riportato $391,7 milioni in contanti, equivalenti di contante e strumenti negoziabili al 30 settembre 2025, che la direzione prevede finanzino le operazioni fino al 2029. MBX ha evidenziato le interazioni regolatorie previste nel primo trimestre del 2026 e l'avvio della fase 3 nel terzo trimestre del 2026, oltre a studi MBX 4291 e imapextide in corso con letture chiave nel 2026.
MBX Biosciences (Nasdaq: MBX) informó resultados positivos de fase 2 topline para canvuparatide administrado una vez a la semana en hipoparatiroidismo, con una tasa de respuesta del 63% a las 12 semanas y del 79% a los seis meses en la extensión de abierto.
La empresa completó una oferta pública fortalecida que levantó aproximadamente $200 millones y reportó $391,7 millones en efectivo, equivalentes en efectivo y valores negociables al 30 de septiembre de 2025, que la dirección espera financiar operaciones hasta 2029. MBX destacó las interacciones regulatorias previstas en el primer trimestre de 2026 y el inicio de la fase 3 en el tercer trimestre de 2026, además de los ensayos en curso de MBX 4291 e imapextide con lecturas clave en 2026.
MBX Biosciences (나스닥: MBX)는 한 주에 한 번 투여하는 canvuparatide가 저하부갑상샘증에서 2상 topline 결과가 긍정적이라고 보고했으며, 개방형 확장 연구에서 12주에 63%, 6개월에 79%의 반응자율을 나타냈습니다.
회사는 대략 $200 million을 모집하는 상장 대폭 증액 공모를 완료했고, 2025년 9월 30일 기준 현금 및 현금성자산과 시장성 증권으로 $391.7 million를 보고했으며, 경영진은 이를 통해 운영을 2029년까지 자금을 조달할 것으로 예상합니다. MBX는 2026년 1분기에 규제 상호작용 계획과 2026년 3분기에 3상 시작을 강조했고, 2026년 주요 발표가 있을 MBX 4291 및 imapextide 임상시험도 진행 중이라고 덧붙였습니다.
MBX Biosciences (Nasdaq: MBX) a rapporté des résultats positifs de la phase 2 topline pour le canvuparatide administré une fois par semaine dans l'hypoparathyroïdie, avec 63% de répondants à 12 semaines et 79% à six mois dans l'extension en ouvert.
L'entreprise a terminé une augmentation d'offre publique levant environ $200 millions et a indiqué $391,7 millions en espèces, équivalents de trésorerie et valeurs mobilières au 30 septembre 2025, que la direction prévoit de financer les opérations jusqu'en 2029. MBX a mis en évidence les interactions réglementaires prévues au premier trimestre 2026 et un démarrage de la phase 3 au troisième trimestre 2026, ainsi que les essais MBX 4291 et imapextide en cours avec des lectures clés prévues en 2026.
MBX Biosciences (Nasdaq: MBX) meldete positive Phase-2-Topline-Ergebnisse für Canvuparatide, das wöchentlich verabreicht wird, bei Hypoparathyreoidismus, mit einer Responder-Rate von 63% nach 12 Wochen und 79% nach sechs Monaten in der Open-Label-Erweiterung.
Das Unternehmen hat eine überzeichnete öffentliche Angebot abgeschlossen, das etwa $200 Millionen einbrachte, und meldete zum 30. September 2025 $391,7 Millionen an Bargeld, Barmitteln und marktfähigen Wertpapieren, von denen das Management erwartet, dass sie die Operationen bis ins 2029 finanzieren. MBX hob geplante regulatorische Interaktionen im 1. Quartal 2026 und einen Start der Phase 3 im 3. Quartal 2026 hervor, außerdem laufende MBX 4291- und Imapextide-Studien mit wichtigen Ergebnissen im Jahr 2026.
MBX Biosciences (ناسداك: MBX) أعلنت عن نتائج إيجابية للمرحلة 2 topline لـ canvuparatide المعطاة أسبوعيًا في قصور الغدة الجار درقية، مع معدل المستجيبين 63% عند 12 أسبوعًا و< b>79% عند ستة أشهر في التوسع المفتوح.
أكملت الشركة عرضًا عامًا موسعًا جذب حوالي $200 مليون وأعلنت عن وجود $391.7 مليون من النقد وما يعادله من النقد والأوراق المالية القابلة للتداول حتى 30 سبتمبر 2025، وتوقّع الإدارة تمويل العمليات حتى 2029. أشارت MBX إلى تفاعلات تنظيمية مخطط لها في الربع الأول من 2026 وبداية تجربة المرحلة 3 في الربع الثالث من 2026، إلى جانب تجارب MBX 4291 وimapextide الجارية مع قراءات رئيسية في 2026.
- Canvuparatide Phase 2 responders: 63% at 12 weeks
- Canvuparatide open-label responders: 79% at six months
- Completed upsized offering: $200M gross proceeds
- Cash and marketable securities: $391.7M (9/30/2025)
- Cash runway expected to fund operations into 2029
- Planned Phase 3 initiation for canvuparatide in Q3 2026
- Net loss for Q3 2025: $21.6M versus $18.1M year-ago
- R&D expense increase: $2.6M (+15.6% YoY) in Q3 2025
- G&A expense increase: $1.8M (+62% YoY) in Q3 2025
Insights
Positive Phase 2 topline and a large financing materially de‑risk near‑term development and commercialization steps.
Once‑weekly canvuparatide met the Phase 2 primary composite endpoint with
Key dependencies and risks are explicit: regulatory engagement and trial execution. Planned regulatory meetings in
Watch the scheduled milestones in
Reported positive topline results from the Phase 2 Avail™ trial of once-weekly canvuparatide in hypoparathyroidism (HP)
Completed upsized public offering, raising approximately
Updated 2026 corporate milestones include clinical data for three Precision Endocrine Peptide™ (PEP) programs and initiation of a Phase 3 trial in HP
CARMEL, Ind., Nov. 06, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today reported financial results for the third quarter ended September 30, 2025, and highlighted recent corporate progress.
“The third quarter of 2025 marked another quarter of significant execution as we reported positive topline results from our Phase 2 Avail™ trial of once-weekly canvuparatide,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “These strong results support our belief that canvuparatide has the potential to be best-in-class in hypoparathyroidism, an estimated multibillion dollar market. We are preparing for meetings with US and EU regulatory agencies, initiation of our Phase 3 trial and future commercialization. With a clinically validated PEP™ platform, and cash runway into 2029, MBX is well positioned to execute on our value-creating milestones in 2026 across our pipeline and become a leading, fully integrated endocrine and metabolic disease biopharma company.”
In November 2025, the Company's board of directors appointed Steve Hoerter to serve as executive chairperson, to support the Company’s executive team with his perspective and commercialization experience, as the Company prepares for the start of a Phase 3 trial and begins pre-commercial activities. Mr. Hoerter joined the Company’s board of directors earlier this year, bringing more than 30 years of pharmaceutical commercialization and executive leadership experience, most recently as President and Chief Executive Officer of Deciphera Pharmaceuticals until its
Third Quarter 2025 and Recent Corporate Highlights
Hypoparathyroidism (HP): Canvuparatide (MBX 2109)
- Positive topline results from Phase 2 Avail™ trial of once-weekly canvuparatide support Phase 3 advancement: The Company announced that once-weekly canvuparatide achieved the primary composite endpoint in the Phase 2 Avail™ trial in adults with hypoparathyroidism, with
63% of canvuparatide-treated patients achieving responder status at 12 weeks, and79% achieving responder status at six months in the ongoing open-label extension study. Canvuparatide is the Company’s potential once-weekly parathyroid hormone (PTH) peptide prodrug. - The Company expects to conduct an End of Phase 2 meeting with the U.S. Food and Drug Administration and Scientific Advice with the European Medicines Agency in Q1 2026. The Company also intends to present Avail™ Phase 2 results at a medical meeting in Q2 2026; report one-year results from its ongoing canvuparatide open-label extension study in Q2 2026; and initiate a Phase 3 trial in Q3 2026.
Obesity: MBX 4291
- Dosed first participant in Phase 1 trial of MBX 4291 for the treatment of obesity (NCT07142707): The Company initiated its first clinical trial in obesity with the dosing of the first participant in the Phase 1 study of MBX 4291, a Precision Endocrine Peptide™ (PEP™) glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) co-agonist prodrug. The three-part, randomized, double-blind, placebo-controlled trial is designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending (SAD and MAD) doses in adults with obesity.
- Planned 12-week MAD portion: Following completion of Parts A and B, the Company plans to evaluate multiple ascending doses of MBX 4291, or matching placebo, administered over 12 weeks in up to two cohorts consisting of 30 participants each in a 2:1 randomization ratio. Participants are expected to receive up to a total of 12 study intervention administrations one week or one week and one month apart with increasing doses of MBX 4291 and will be followed for 120 days after the first dose. Results from the planned 12-week MAD portion are expected in Q4 2026.
Post-bariatric Hypoglycemia (PBH): Imapextide (MBX 1416)
- Dosed first patient in Phase 2a STEADI™ trial of imapextide (MBX1416) for post-bariatric hypoglycemia (NCT07029412): The Company initiated a Phase 2a, open-label exploratory study to evaluate preliminary efficacy of subcutaneous imapextide in patients with PBH. Approximately ten patients aged 18 to 65 years with a history of hypoglycemia following Roux-en-Y or sleeve gastrectomy will be included in the study. Participants will undergo three mixed-meal tolerance tests, one at baseline and again 48 hours after each imapextide administration, to evaluate the effect of imapextide on increasing post-prandial glucose nadir. Imapextide’s effect in reducing post-prandial insulin and C-peptide peaks will also be evaluated. Results are expected in Q2 2026.
Corporate
- Completed upsized public offering: The Company completed an upsized public offering of its common stock, raising approximately
$200 million in gross proceeds before deducting underwriting discounts, commissions, and other offering expenses.
Anticipated Milestones
- Canvuparatide
- Q1 2026: End of Phase 2 meeting and EMA Scientific Advice
- Q2 2026: Presentation of Phase 2 results at a medical meeting
- Q2 2026: Phase 2 one-year open label extension study data
- Q3 2026: Phase 3 canvuparatide HP trial initiation
- MBX 4291
- Q4 2026: Results from 12-week multiple ascending dose portion of Phase 1 trial of MBX 4291 for the treatment of obesity
- Imapextide
- Q2 2026: Phase 2a STEADI™ trial results of imapextide for the treatment of post-bariatric hypoglycemia (PBH)
- Q2 2026: Phase 2a STEADI™ trial results of imapextide for the treatment of post-bariatric hypoglycemia (PBH)
Third Quarter 2025 Financial Results
- Cash and Cash Equivalents and Marketable Securities: As of September 30, 2025, the Company had cash, cash equivalents and marketable securities of
$391.7 million , which includes proceeds from its upsized public offering. Based on its current operating plan, management expects the combined cash and marketable securities balance to fund operations into 2029. - R&D Expenses: Research and development expenses for the three months ended September 30, 2025, were
$19.3 million compared to$16.7 million for the same period in 2024. The increase of$2.6 million was driven by costs associated with the ongoing MBX 4291 Phase 1 clinical trial and the canvuparatide Phase 2 clinical trial. - G&A Expenses: General and administrative expenses for the three months ended September 30, 2025, were
$4.7 million compared to$2.9 million for the same period in 2024. The increase of$1.8 million was driven by increased personnel-related costs as the Company expanded its infrastructure to support its growth in operations as a public company. - Net Loss: Net loss for the three months ended September 30, 2025, was
$21.6 million compared to a net loss of$18.1 million for the same period in 2024.
About MBX Biosciences
MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism (HP) preparing for Phase 3 development; imapextide (MBX 1416) for the treatment of post-bariatric hypoglycemia (PBH) in Phase 2 development; and an obesity portfolio that includes MBX 4291 in Phase 1 development, as well as multiple discovery and pre-clinical obesity candidates. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.
About MBX’s Proprietary Precision Endocrine Peptide (PEP™) Platform
MBX was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: MBX Biosciences’ expectations regarding the Phase 2 trial of canvuparatide, including timing of results from the open-label extension and timing of initiation of a Phase 3 trial; the potential for canvuparatide to be a best-in-class, once-weekly PTH replacement therapy; the expected timing of results from the Phase 2a trial for imapextide; statements related to the ability of imapextide to be a treatment of PBH; the expected timing of results from the Phase 1 trial for MBX 4291; and expectations regarding MBX Biosciences’ uses of capital, expenses and financial results, including the anticipated cash runway timing.
Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect MBX Biosciences’ business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company’s research and development activities; MBX Biosciences’ ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to preclinical and clinical development activities; the Company’s dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; MBX Biosciences’ ability to attract, integrate and retain key personnel; risks related to the Company’s financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining MBX Biosciences’ intellectual property protections; and risks related to the competitive landscape for MBX Biosciences’ product candidates; as well as other risks described in “Risk Factors,” in MBX Biosciences’ Quarterly Report on Form 10-Q for the three months ended September 30, 2025, Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC), as well as subsequent filings with the SEC. MBX Biosciences expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
MBX uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company's Investor Relations website, in addition to following the Company's press releases, SEC filings, public conference calls, presentations, and webcasts.
Media Contact:
Cassidy McClain
Inizio Evoke Comms
cassidy.mcclain@inizioevoke.com
(619) 694-6291
Investor Contact:
Jim DeNike
MBX Biosciences
jdenike@mbxbio.com
| MBX BIOSCIENCES, INC. | |||||||||||||||||
| SELECTED FINANCIAL INFORMATION | |||||||||||||||||
| (Unaudited) | |||||||||||||||||
| Statements of Operations Data: | Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| (in thousands, except per share and per share data) | 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | $ | 19,270 | $ | 16,747 | $ | 59,400 | $ | 42,192 | |||||||||
| General and administrative | 4,656 | 2,865 | 12,860 | 7,392 | |||||||||||||
| Total operating expenses | 23,926 | 19,612 | 72,260 | 49,584 | |||||||||||||
| Loss from operations | (23,926 | ) | (19,612 | ) | (72,260 | ) | (49,584 | ) | |||||||||
| Interest and other income, net | 2,308 | 1,470 | 7,351 | 3,248 | |||||||||||||
| Net loss | $ | (21,618 | ) | $ | (18,142 | ) | $ | (64,909 | ) | $ | (46,336 | ) | |||||
| Net loss per common share, basic and diluted | $ | (0.63 | ) | $ | (2.78 | ) | $ | (1.93 | ) | $ | (15.42 | ) | |||||
| Weighted average number of common shares outstanding used in computation of net loss per common share, basic and diluted | 34,198,597 | 6,515,616 | 33,688,669 | 3,004,382 | |||||||||||||
| (Unaudited) | |||||||||||||||||
| Balance Sheets Selected Financial Data: | September 30, | December 31, | |||||||||||||||
| (in thousands) | 2025 | 2024 | |||||||||||||||
| Cash, cash equivalents and marketable securities | $ | 391,673 | $ | 262,149 | |||||||||||||
| Working capital(1) | 385,440 | 256,235 | |||||||||||||||
| Total assets | 400,076 | 268,535 | |||||||||||||||
| Total liabilities | 12,538 | 11,093 | |||||||||||||||
| Accumulated deficit | (202,414 | ) | (137,505 | ) | |||||||||||||
| Total stockholders’ equity | 387,538 | 257,442 | |||||||||||||||
| (1) Working capital is defined as total current assets less total current liabilities. See our financial statements and the related notes thereto included in our Quarterly Report on Form 10-Q for the Quarter Ending September 30, 2025 and Year Ending December 31, 2024 for further details regarding our current assets and current liabilities. | |||||||||||||||||
FAQ
What were MBX (MBX) Phase 2 Avail topline results for canvuparatide on Nov 6, 2025?
How much cash did MBX (MBX) report on Sep 30, 2025 and how long will it fund operations?
When does MBX (MBX) plan to start Phase 3 for canvuparatide?
What recent financing did MBX (MBX) complete in 2025?
What clinical milestones does MBX (MBX) expect in 2026 for its pipeline?
How did MBX (MBX) expenses and net loss change in Q3 2025?
