MBX Biosciences to Provide 2026 Outlook and Business Update at 44th Annual J.P. Morgan Healthcare Conference

Rhea-AI Summary

MBX Biosciences (Nasdaq: MBX) will present at the 44th Annual J.P. Morgan Healthcare Conference on Jan 13, 2026 and provide a 2026 outlook and business update.

Key clinical milestones: one-year follow-up data from the Phase 2 once-weekly canvuparatide expected Q2 2026 with Phase 3 initiation targeted Q3 2026; Phase 1 12-week data for once-monthly potential MBX 4291 expected Q4 2026; two additional obesity candidates nominated in 2026 (amycretin prodrug and GLP-1/GIP/GCGR prodrug). Preliminary unaudited cash and marketable securities were approximately $373.7M as of Dec 31, 2025, expected to fund operations into 2029.

Positive

• Phase 2 canvuparatide met its primary endpoint in Avail trial
• One-year canvuparatide follow-up data due in Q2 2026
• Phase 3 for canvuparatide targeted to start in Q3 2026
• Preliminary cash and marketable securities of $373.7M at 12/31/2025

Negative

• Pivotal Phase 3 for canvuparatide not yet initiated
• MBX 4291 remains in Phase 1 with 12-week data pending Q4 2026
• Two additional obesity candidates are nominations, not yet clinical programs

News Market Reaction

+15.19% 1.5x vol

50 alerts

+15.19% News Effect

+8.8% Peak in 6 hr 15 min

+$216M Valuation Impact

$1.64B Market Cap

1.5x Rel. Volume

On the day this news was published, MBX gained 15.19%, reflecting a significant positive market reaction. Argus tracked a peak move of +8.8% during that session. Our momentum scanner triggered 50 alerts that day, indicating high trading interest and price volatility. This price movement added approximately $216M to the company's valuation, bringing the market cap to $1.64B at that time. Trading volume was above average at 1.5x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cash & equivalents: $373.7 million Operational runway: Into 2029 Avail trial dataset: 12-week data +2 more

5 metrics

Cash & equivalents $373.7 million Preliminary unaudited as of December 31, 2025

Operational runway Into 2029 Management expectation based on current cash position

Avail trial dataset 12-week data Full Phase 2 Avail dataset to be shared in Q2 2026

MBX 4291 data 12-week multiple ascending dose Phase 1 obesity trial readout anticipated Q4 2026

New obesity candidates 2 candidates Amycretin prodrug and GLP-1/GIP/GCGR prodrug nominations in 2026

Market Reality Check

Price: $42.39 Vol: Volume 412,142 is 0.55x t...

low vol

$42.39 Last Close

Volume Volume 412,142 is 0.55x the 20-day average of 753,845, suggesting subdued trading interest before the update. low

Technical Shares trade above the 200-day MA, with price at $31.66 vs 200-day MA of $16.27.

Peers on Argus

MBX gained 3.06% while peers showed mixed moves (e.g., FDMT +1.21%, RCKT -4.36%,...

MBX gained 3.06% while peers showed mixed moves (e.g., FDMT +1.21%, RCKT -4.36%, TECX -4.59%), indicating a stock-specific reaction rather than a coordinated biotech move.

Historical Context

5 past events · Latest: Dec 15 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 15	Conference participation	Neutral	-5.0%	Announcement of J.P. Morgan conference presentation and webcast details.
Nov 18	Conference participation	Neutral	+2.9%	Participation in Piper Sandler healthcare conference with webcast access.
Nov 06	Earnings and pipeline	Positive	+9.7%	Positive Phase 2 canvuparatide data and strong cash from upsized offering.
Oct 20	Multiple conferences	Neutral	+7.6%	Plans to present at four November investor conferences with webcasts.
Sep 29	Conference appearance	Neutral	+2.5%	Virtual cardiometabolic forum fireside chat and webcast availability.

Pattern Detected

The stock tended to react positively to substantive updates like earnings and pipeline data, while routine conference announcements saw smaller, mixed moves.

Recent Company History

Over the last several months, MBX highlighted multiple investor and healthcare conference appearances on Sep 29, 2025, Oct 20, 2025, Nov 18, 2025, and Dec 15, 2025, which generally produced modest price changes. A key catalyst came with Q3 2025 results on Nov 6, 2025, combining positive Phase 2 canvuparatide data and a strengthened cash position, leading to a 9.71% gain. Today’s outlook extends that narrative with concrete 2026 milestones and updated cash levels expected to fund operations into 2029.

Regulatory & Risk Context

Active S-3 Shelf · $400,000,000

Shelf Active

Active S-3 Shelf Registration 2025-11-06

$400,000,000 registered capacity

An effective S-3 shelf filed on 2025-11-06 permits MBX to offer up to $400,000,000 of securities, including an ATM program for up to $150,000,000 of common stock within that capacity, providing flexibility to raise capital in support of its clinical programs.

Market Pulse Summary

The stock surged +15.2% in the session following this news. A strong positive reaction aligns with M...

Analysis

The stock surged +15.2% in the session following this news. A strong positive reaction aligns with MBX’s status above its 200-day MA at $16.27 and prior enthusiasm for concrete pipeline and balance sheet updates, such as the 9.71% move on the Q3 2025 earnings and data release. However, the presence of a $400,000,000 shelf and ATM capacity means future capital raises remain possible, which, alongside prior offerings, could temper sustainability if expectations for 2026 clinical milestones are not met.

Key Terms

glp-1, gip, gcgr, phase 2, +2 more

6 terms

glp-1 medical

"MBX 4291, a glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic peptide (GIP)"

GLP-1 (glucagon-like peptide-1) is a natural hormone in the body that helps regulate blood sugar levels and appetite. Its significance to investors lies in its role as the basis for a class of medications that address conditions like type 2 diabetes and obesity, which are large and growing markets. Advances or investments in GLP-1-based treatments can signal opportunities in healthcare innovation and potentially impact pharmaceutical companies’ growth.

gip medical

"glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic peptide (GIP) co-agonist prodrug"

GIP commonly stands for Global Infrastructure Partners, a private investment firm that buys and manages large physical assets such as airports, power plants, toll roads and pipelines. Investors pay attention because when GIP acquires, invests in, or sells such assets it can alter cash flow, debt levels and long-term plans for those businesses—like a new landlord changing rents or making upgrades—affecting revenue, dividends and risk for shareholders and creditors.

gcgr medical

"a GLP-1/GIP/GCGR triple agonist, each designed for once-monthly dosing"

GCGR is the cell-surface protein that binds the hormone glucagon, acting like a lock that opens when glucagon — a signal that raises blood sugar — fits into it. It matters to investors because medicines that block or activate this receptor are central to treatments for diabetes and metabolic disease, so progress, safety results, or regulatory decisions about GCGR-targeting drugs can strongly affect a drug developer’s value and future revenue prospects.

phase 2 medical

"One-year follow-up data from Phase 2 trial of once-weekly canvuparatide"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

phase 3 medical

"Phase 3 initiation on track for Q3 2026"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 1 medical

"12-week data from Phase 1 trial of MBX 4291, a dual GLP-1/GIP co-agonist"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

AI-generated analysis. Not financial advice.

One-year follow-up data from Phase 2 trial of once-weekly canvuparatide, a potential best-in-class therapy for hypoparathyroidism, anticipated in Q2 2026; Phase 3 initiation on track for Q3 2026

12-week data from Phase 1 trial of MBX 4291, a dual GLP-1/GIP co-agonist prodrug with potential for once-monthly dosing and improved tolerability for obesity, anticipated in Q4 2026

Nomination of two additional obesity candidates expected in 2026: an amycretin prodrug and a GLP-1/GIP/GCGR triple agonist, each designed for once-monthly dosing

Strong cash position: preliminary unaudited cash, cash equivalents and marketable securities of approximately $373.7 million as of December 31, 2025, expected to fund operations into 2029

CARMEL, Ind., Jan. 11, 2026 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced it will provide an update on its clinical programs, expanding obesity pipeline, and outlook for 2026 during the Company’s presentation at the 44^th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026, at 3:45 pm PT (6:45 pm ET). The live webcast can be accessed in the events section of the MBX Biosciences website at https://investors.mbxbio.com/news-events/events.

“The Phase 2 success with once-weekly canvuparatide in chronic hypoparathyroidism sets the stage for our upcoming pivotal Phase 3 trial, while underscoring the broad clinical utility of our Precision Endocrine Peptide (PEP™) platform,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “We look forward to a catalyst-rich 2026, including the nomination of new development candidates in our expanding obesity portfolio and highly anticipated clinical data from MBX 4291, which holds the promise of potential once-monthly dosing with improved tolerability. With a strong cash position extending into 2029, we are well positioned to execute our strategy and continue to invest in long-term pipeline growth.”

Once-weekly Canvuparatide for Hypoparathyroidism (HP)

• The Phase 2 Avail™ trial (Avail) achieved its primary endpoint, demonstrating strong clinical proof-of-concept for canvuparatide with high responder rates and once-weekly dosing that was generally well-tolerated.
  
• MBX plans to share the full 12-week dataset from Avail and one-year follow-up data at a medical conference in Q2 2026.
  
• An FDA End-of-Phase 2 meeting is planned for Q1 2026, as MBX continues to prepare for initiation of its Phase 3 confirmatory trial in Q3 2026.
  
• Primary market research supports canvuparatide’s potential as a best-in-class therapy and new standard of care for patients with HP.
  

MBX 4291 and Early Pipeline Programs for Obesity

• MBX 4291, a glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic peptide (GIP) co-agonist prodrug with potential for once-monthly dosing, continues to progress through Phase 1 evaluation, with 12-week multiple ascending dose data expected in Q4 2026.
  
• MBX expects to expand its obesity portfolio in 2026 with two additional candidates designed to address the full spectrum of needs for patients with obesity, each with once-monthly dosing. These include an amycretin prodrug and a GLP-1/GIP/glucagon receptor (GCGR) prodrug candidate, with nominations anticipated in Q2 and Q3 2026.
  

Long-acting Imapextide (MBX 1416) for Post-Bariatric Hypoglycemia (PBH)

• Results from the ongoing Phase 2a STEADI™ trial of potential once-weekly imapextide are expected in Q2 2026, including effects on post-prandial glucose regulation and related metabolic parameters.
  
• Results from primary research conducted by MBX indicate that the majority of patients and endocrinologists surveyed prefer the convenience of a once-weekly injection over a once-daily injection in PBH.
  

Strong Cash Position

• Preliminary unaudited cash, cash equivalents and marketable securities of approximately $373.7 million as of December 31, 2025, are expected to fund operations into 2029.
  

About MBX Biosciences

MBX Biosciences is a biopharmaceutical company focused on the discovery, development and commercialization 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; an obesity portfolio that includes MBX 4291 in Phase 1 development, as well as multiple discovery and pre-clinical obesity candidates; and imapextide (MBX 1416) for the treatment of post-bariatric hypoglycemia (PBH) in Phase 2 development. 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 clinical development of canvuparatide, including timing of the one-year follow-up data from the Phase 2 trial in Q2 2026, timing of FDA End-of-Phase 2 and EMA Scientific Advice meetings in Q1 2026 and timing of initiation of a Phase 3 trial in Q3 2026; the potential for canvuparatide to be a best-in-class, once-weekly PTH replacement therapy and a new standard of care for patients with HP; 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; expectations on patient and endocrinologist preference for a once-weekly over a once-daily treatment; the expected timing of results from the Phase 1 trial for MBX 4291 in Q4 2026; the potential for MBX 4291 to be dosed once-monthly with improved tolerability; the expected timing of the announcement of additional obesity candidates in Q2 and Q3 2026; MBX Biosciences’ preliminary unaudited cash, cash equivalents and marketable securities as of December 31, 2025; 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; risks related to the competitive landscape for MBX Biosciences’ product candidates; and final audit adjustments and other developments that may arise that would cause MBX Biosciences’ expectations with respect to the estimate of cash, cash equivalents and marketable securities as of December 31, 2025 to differ, perhaps materially, from the financial results that will be reflected in MBX Biosciences’ audited consolidated financial statements for the fiscal year ended December 31, 2025; 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 Biosciences 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.

Financial Disclosure Advisory
MBX Biosciences has not yet completed its year-end financial close process for the fiscal year ended December 31, 2025. The estimate of the Company’s cash, cash equivalents and marketable securities as of December 31, 2025 is preliminary, has not been audited and is subject to change upon completion of the Company’s financial statement closing procedures. Additional information and disclosure would be required for a more complete understanding of the Company’s financial position and results of operations as of December 31, 2025. The Company’s independent registered public accounting firm has not audited, reviewed or performed any procedures with respect to this preliminary result and, accordingly, does not express an opinion or any other form of assurance about it.

Media Contact:
Cassidy McClain
Inizio Evoke Comms
cassidy.mcclain@inizioevoke.com
(619) 694-6291

Investor Contact:
Jim DeNike
MBX Biosciences
jdenike@mbxbio.com

FAQ

When will MBX (MBX) present its 2026 outlook at J.P. Morgan?

MBX will present on Jan 13, 2026 at 3:45 PM PT (6:45 PM ET) with a live webcast available on the investor events page.

What key canvuparatide data will MBX report in 2026 and when?

MBX expects to report the 12-week Avail dataset and one-year follow-up for canvuparatide in Q2 2026.

When is canvuparatide Phase 3 planned to begin for MBX (MBX)?

An FDA End-of-Phase 2 meeting is planned for Q1 2026 and Phase 3 initiation is targeted for Q3 2026.

What is the timing for MBX 4291 clinical data and its dosing potential?

MBX expects 12-week multiple ascending dose data for MBX 4291 in Q4 2026; the program targets potential once-monthly dosing.

What new obesity candidates does MBX expect to nominate in 2026?

MBX plans to nominate an amycretin prodrug and a GLP-1/GIP/GCGR prodrug in 2026, with nominations expected in Q2 and Q3.

How long is MBX’s cash expected to fund operations?

Preliminary unaudited cash, cash equivalents and marketable securities of approximately $373.7 million as of Dec 31, 2025 are expected to fund operations into 2029.