MBX Biosciences Reports Third Quarter 2024 Financial Results and Provides Business Update
MBX Biosciences reported Q3 2024 financial results, highlighting a successful transition to public trading and advancement of clinical programs. The company raised $251.2 million through an IPO and Series C financing, with $277.1 million in cash expected to fund operations into mid-2027. Key developments include anticipated completion of MBX 1416 Phase 1 trial by late November with topline results in January 2025, and ongoing Phase 2 Avail™ trial of MBX 2109 for hypoparathyroidism expected to complete enrollment in Q1 2025. Q3 financial results showed R&D expenses of $16.7 million and a net loss of $18.1 million.
MBX Biosciences ha riportato i risultati finanziari del terzo trimestre del 2024, evidenziando una riuscita transizione al trading pubblico e progressi nei programmi clinici. L'azienda ha raccolto 251,2 milioni di dollari attraverso un'IPO e un finanziamento di Serie C, con 277,1 milioni di dollari in contante attesi per finanziare le operazioni fino a metà 2027. Gli sviluppi chiave includono il completamento previsto della fase 1 di MBX 1416 entro la fine di novembre, con risultati preliminari a gennaio 2025, e la continua fase 2 della sperimentazione Avail™ di MBX 2109 per l'ipoparatiroidismo, prevista per completare l'arruolamento nel primo trimestre del 2025. I risultati finanziari del terzo trimestre hanno mostrato spese per R&D di 16,7 milioni di dollari e una perdita netta di 18,1 milioni di dollari.
MBX Biosciences informó los resultados financieros del tercer trimestre de 2024, destacando una exitosa transición a la negociación pública y el avance de los programas clínicos. La empresa recaudó 251.2 millones de dólares a través de una IPO y financiamiento de Serie C, con 277.1 millones de dólares en efectivo que se espera financien las operaciones hasta mediados de 2027. Los desarrollos clave incluyen la finalización anticipada del ensayo Fase 1 de MBX 1416 para finales de noviembre, con resultados preliminares en enero de 2025, y el ensayo en curso de Fase 2 Avail™ de MBX 2109 para hipoparatiroidism, que se espera complete la inscripción en el primer trimestre de 2025. Los resultados financieros del tercer trimestre mostraron gastos de I+D de 16.7 millones de dólares y una pérdida neta de 18.1 millones de dólares.
MBX Biosciences는 2024년 3분기 재무 결과를 발표하며, 성공적인 상장 및 임상 프로그램의 발전을 강조했습니다. 이 회사는 IPO와 시리즈 C 자금 조달을 통해 2억 5120만 달러를 모금했으며, 운영 자금을 위한 현금으로 2억 7710만 달러가 2027년 중반까지 지원될 것으로 예상됩니다. 주요 개발 사항으로는 11월 말까지 MBX 1416 1상 시험의 완료가 예상되며, 2025년 1월에 탑라인 결과가 발표될 것입니다. 또한, MBX 2109의 2상 Avail™ 시험이 진행 중이며, 저식사이에서 첫 분기 2025년 1분기 등록이 완료될 것으로 기대됩니다. 3분기 재무 결과는 R&D 비용이 1670만 달러에 달하고, 순손실이 1810만 달러로 나타났습니다.
MBX Biosciences a rapporté les résultats financiers du troisième trimestre 2024, soulignant une transition réussie vers la cotation publique et l'avancement des programmes cliniques. La société a levé 251,2 millions de dollars grâce à une introduction en bourse et un financement de série C, avec 277,1 millions de dollars en espèces prévus pour financer les opérations jusqu'à mi-2027. Les développements clés incluent l'achèvement anticipé de l'essai de phase 1 MBX 1416 d'ici fin novembre, avec des résultats préliminaires en janvier 2025, et l'essai de phase 2 Avail™ en cours de MBX 2109 pour l'hypoparathyroïdie, dont l'inscriptions devrait être finalisée au premier trimestre 2025. Les résultats financiers du troisième trimestre ont montré des dépenses en R&D de 16,7 millions de dollars et une perte nette de 18,1 millions de dollars.
MBX Biosciences berichtete über die finanziellen Ergebnisse für das dritte Quartal 2024 und hob den erfolgreichen Übergang zum öffentlichen Handel sowie den Fortschritt der klinischen Programme hervor. Das Unternehmen hat 251,2 Millionen Dollar durch einen IPO und eine Serie-C-Finanzierung gesammelt, wobei 277,1 Millionen Dollar an liquiden Mitteln erwartet werden, um die Betriebe bis Mitte 2027 zu finanzieren. Zu den wichtigsten Entwicklungen gehört der voraussichtliche Abschluss der MBX 1416 Phase 1 Studie bis Ende November mit ersten Ergebnissen im Januar 2025 sowie die laufende Phase 2 Avail™ Studie von MBX 2109 gegen Hypoparathyreoidismus, die voraussichtlich im ersten Quartal 2025 abgeschlossen wird. Die finanziellen Ergebnisse des dritten Quartals zeigten F&E-Ausgaben von 16,7 Millionen Dollar und einen Nettoverlust von 18,1 Millionen Dollar.
- Raised $251.2 million through IPO and Series C financing
- Strong cash position of $277.1 million to fund operations into mid-2027
- Multiple clinical milestones approaching in Q1 2025
- Net loss increased to $18.1 million from $10.2 million YoY
- R&D expenses increased 84% to $16.7 million YoY
- G&A expenses increased by $1.0 million YoY
Insights
The financial position of MBX Biosciences has significantly strengthened following their successful IPO and Series C financing, raising
Q3 financial metrics show increased R&D spending at
The company's pipeline progress, particularly with MBX 2109 and MBX 1416, coupled with strong cash reserves, positions them well for upcoming clinical milestones. The obesity market potential adds significant upside to their valuation prospects.
The clinical development pipeline shows promising momentum across multiple programs. MBX 2109's Phase 2 Avail trial for hypoparathyroidism is progressing well, with completion expected in Q1 2025. The upcoming topline results for MBX 1416's Phase 1 trial in January 2025 will be important in validating their GLP-1 receptor antagonist approach for post-bariatric hypoglycemia.
The advancement of MBX 4291, their GLP-1/GIP co-agonist for obesity treatment, towards IND submission in Q2 2025 is particularly noteworthy given the explosive growth in the GLP-1 market. Their focus on precision peptide therapies and multiple shots on goal in the metabolic disease space demonstrates a well-thought-out development strategy.
Total gross proceeds from upsized initial public offering and Series C financing were approximately
Last subject last visit in Phase 1 trial of MBX 1416 anticipated by late November; topline results to be reported in early January 2025
Enrollment of Phase 2 Avail™ trial of MBX 2109 in hypoparathyroidism on track to complete in Q1 2025; topline results anticipated in Q3 2025
Strong cash position, with
CARMEL, Ind., Nov. 07, 2024 (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, 2024, and highlighted recent progress.
“The third quarter of 2024 has been transformational for MBX, as we transitioned to a publicly traded company and advanced our clinical-stage precision peptide programs,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “Our team is committed to delivering on our upcoming clinical milestones, including completion of the last subject visit in the Phase 1 trial of MBX 1416 anticipated by late November, and we expect to report top line results for this trial in early January 2025. In addition, enrollment in the Phase 2 trial of MBX 2109 in patients with hypoparathyroidism is on track to be complete in the first quarter of 2025, and we continue to expect topline results in the third quarter of 2025. The capital raised in our initial public offering in September and our Series C financing in August enables us to execute on these clinical milestones and advance the development of our early-stage pipeline programs, including our obesity portfolio, as we aim to overcome limitations of current therapies and improve the standard of care.”
Third Quarter 2024 and Recent Business Highlights
MBX 2109
- Presented the rationale and design of the Phase 2 Avail™ trial of MBX 2109: In September 2024, the Phase 2 Avail trial of MBX 2109, the Company’s potential long-acting parathyroid hormone (PTH) peptide prodrug, in adults with hypoparathyroidism (HP) was featured in a poster presentation at the American Society for Bone and Mineral Research 2024 Annual Meeting held in Toronto, ON, Canada.
- Initiated Phase 2 Avail trial of MBX 2109: In August 2024, the Company announced that the first patient was dosed in the Phase 2 Avail trial of MBX 2109. Enrollment is expected to complete in the first quarter of 2025 with topline results expected in the third quarter of 2025.
MBX 1416
- Last Subject Last Visit in MBX 1416 Phase 1 trial anticipated by late November 2024: MBX expects the last subject visit to be completed by the end of November in the Phase 1 single and multiple ascending dose trial of MBX 1416, the Company’s long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist in development for the treatment of post-bariatric hypoglycemia. The Company plans to announce topline results in early January 2025.
MBX 4291
- Progressing MBX 4291 IND-enabling studies: MBX is in the process of completing investigational new drug (IND) enabling studies for its GLP-1/GIP co-agonist prodrug MBX 4291 for the potential treatment of obesity and expects to submit an IND application to the U.S. Food and Drug Administration in the second quarter of 2025. The Company also has additional programs in the lead optimization stage of development for the treatment of obesity and associated comorbidities.
Corporate
- Completed upsized initial public offering (IPO) and Series C financing: In September 2024, MBX completed its IPO following its Series C financing in August. Total gross proceeds from the Initial Public Offering and Series C financing were approximately
$251.2 million .
Third Quarter 2024 Financial Results
- Cash and Cash Equivalents and Marketable Securities: As of September 30, 2024, MBX had cash, cash equivalents and marketable securities of
$277.1 million compared to$80.7 million as of December 31, 2023. Based on its current operating plan, management expects the combined cash, cash equivalents and marketable securities balance to fund operations into mid-2027.
- R&D Expenses: Research and development expenses for the three months ended September 30, 2024, were
$16.7 million compared to$9.1 million for the same period in 2023. The increase of$7.7 million was driven by costs associated with ongoing IND-enabling studies for MBX 4291 and the ongoing MBX 2109 Phase 2 clinical trial.
- G&A Expenses: General and administrative expenses for the three months ended September 30, 2024, were
$2.9 million compared to$1.9 million for the same period in 2023. The increase of$1.0 million was driven by increased personnel-related costs as the Company expanded its infrastructure to support its growth in operations.
- Net Loss: Net loss for the three months ended September 30, 2024, was
$18.1 million compared to a net loss of$10.2 million for the same period in 2023.
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 its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. 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 Avail™ trial of MBX 2109, including the timing of patient enrollment and topline results, the Phase 1 trial of MBX 1416, including the timing of the last subject visit and topline results, IND-enabling studies in MBX 4291, including MBX Biosciences’ intention to submit an IND and the timing related thereto, and other product candidates in the lead optimization stage; and expectations regarding MBX Biosciences’ uses of capital, expenses and financial results, including the expected cash runway.
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’ Registration Statement on Form S-1 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:
Kate Burdick
Inizio Evoke Comms
kate.burdick@inizioevoke.com
860-462-1569
Investor Contact:
Jim DeNike
MBX Biosciences
jdenike@mbxbio.com
| MBX BIOSCIENCES, INC. | |||||||||||||||||
| CONDENSED FINANCIAL INFORMATION | |||||||||||||||||
| (Unaudited) | |||||||||||||||||
| Condensed Statements of Operations Data: | Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| (in thousands, except per share and per share data) | 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | $ | 16,747 | $ | 9,073 | $ | 42,192 | $ | 20,807 | |||||||||
| General and administrative | 2,865 | 1,872 | 7,392 | 4,513 | |||||||||||||
| Total operating expenses | 19,612 | 10,945 | 49,584 | 25,320 | |||||||||||||
| Loss from operations | (19,612 | ) | (10,945 | ) | (49,584 | ) | (25,320 | ) | |||||||||
| Interest and other income, net | 1,470 | 783 | 3,248 | 1,600 | |||||||||||||
| Net loss | $ | (18,142 | ) | $ | (10,162 | ) | $ | (46,336 | ) | $ | (23,720 | ) | |||||
| Net loss per common share, basic and diluted | $ | (2.78 | ) | $ | (9.40 | ) | $ | (15.42 | ) | $ | (24.28 | ) | |||||
| Weighted average number of common shares outstanding used in computation of net loss per common share, basic and diluted | 6,515,616 | 1,081,349 | 3,004,382 | 976,824 | |||||||||||||
| Condensed Balance Sheet Data: | September 30, | December 31, | |||||||||||||||
| (in thousands) | 2024 | 2023 | |||||||||||||||
| Cash, cash equivalents and marketable securities | $ | 277,063 | $ | 80,676 | |||||||||||||
| Working capital(1) | 270,250 | 79,539 | |||||||||||||||
| Total assets | 282,400 | 84,180 | |||||||||||||||
| Total liabilities | 11,032 | 4,291 | |||||||||||||||
| Convertible preferred stock | - | 152,357 | |||||||||||||||
| Accumulated deficit | (121,919 | ) | (75,583 | ) | |||||||||||||
| Total stockholders equity (deficit) | 271,368 | (72,468 | ) | ||||||||||||||
| (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, 2024 for further details regarding our current assets and current liabilities. | |||||||||||||||||
FAQ
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