Core Insights - MBX Biosciences announced positive top-line results from its Phase II clinical trial of once-weekly canvuparatide for patients with hypoparathyroidism [2] Group 1: Clinical Trial Results - The Phase II trial demonstrated promising outcomes for canvuparatide in treating hypoparathyroidism [2] - Six-month results from the ongoing open-label extension study were also reported [2] Group 2: Company Leadership - The conference call featured key executives from MBX, including CEO Kent Hawryluk, CMO Dr. Sam Azoulay, and CFO Rick Bartram [4]

Company Overview - MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing novel precision peptide therapies for endocrine and metabolic disorders [5] - The company utilizes its proprietary PEP™ platform to advance a pipeline of candidates targeting significant unmet medical needs with large market opportunities [5] Public Offering Details - MBX Biosciences announced the pricing of its upsized public offering of 11,108,055 shares at a price of $18.00 per share, expecting gross proceeds of approximately $199.9 million before deductions [1] - The offering includes a 30-day option for underwriters to purchase an additional 1,666,208 shares at the public offering price [1] - The offering is expected to close on September 26, 2025, pending customary closing conditions [1] Underwriters - J.P. Morgan, Jefferies, TD Cowen, and Guggenheim Securities are acting as joint book-running managers for the offering [2] - Citizens Capital Markets and Oppenheimer & Co. are serving as co-lead managers [2] Regulatory Compliance - A registration statement for the offering was filed with the Securities and Exchange Commission and declared effective on September 24, 2025 [3] - The offering is being conducted solely through a prospectus [3]

Core Viewpoint - MBX Biosciences, Inc. (MBX) shares have increased by 44% in the past four weeks, closing at $20, with a mean price target of $37.71 indicating a potential upside of 88.6% according to Wall Street analysts [1] Price Targets and Analyst Estimates - The mean estimate consists of seven short-term price targets with a standard deviation of $4.23, where the lowest estimate is $30.00 (50% increase) and the highest is $44.00 (120% increase) [2] - A low standard deviation suggests a strong agreement among analysts regarding the price targets, indicating less variability in their estimates [2][9] Earnings Estimates and Analyst Sentiment - Analysts show strong agreement in revising earnings estimates higher, which is a positive indicator for potential stock upside [4][11] - The Zacks Consensus Estimate for the current year has risen by 2.7% over the past month, with one estimate increasing and no negative revisions [12] Zacks Rank and Investment Potential - MBX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] - While consensus price targets may not be entirely reliable, the direction they imply appears to be a good guide for potential price movement [14]

Earnings Reports - AutoZone Inc. is expected to report quarterly earnings of $50.83 per share with revenue of $6.24 million [2] - Firefly Aerospace Inc. reported a second-quarter loss of $5.78 per share, an increase from a loss of $4.60 per share a year ago, with sales declining to $15.549 million from $21.071 million [2] - AAR Corp. is anticipated to post earnings of 98 cents per share on revenue of $688.72 million for the latest quarter [2] - Micron Technology Inc. is expected to report quarterly earnings of $2.86 per share with revenue of $11.22 billion [2] Stock Performance - AutoZone shares decreased by 0.5% to close at $4,121.00 [2] - Firefly Aerospace shares fell by 12.4% to $43.38 in after-hours trading [2] - AAR shares increased by 0.5% to $77.28 in after-hours trading [2] - MBX Biosciences Inc. shares declined by 2.1% to $19.58 in after-hours trading [2] - Micron shares rose by 1% to $166.30 in after-hours trading [2]

Core Insights - Companies involved in peptide drug design and development are experiencing positive market movements, particularly Metsera with its glucagon-like peptide 1 receptor agonist (GLP-1 RA) drugs [1] Group 1: Company Developments - Metsera is highlighted for its portfolio of GLP-1 RA drugs, indicating a significant focus on this area within the biotech sector [1] - The investing group Haggerston BioHealth provides insights into catalysts for both novice and experienced biotech investors, emphasizing the importance of understanding market trends [1] Group 2: Market Analysis - The newsletter from Haggerston BioHealth offers detailed financial forecasts, integrated financial statements, and market-by-market analysis for major pharmaceutical companies, which is crucial for investment decisions [1]

Core Viewpoint - MBX Biosciences, Inc. has filed a registration statement for a proposed public offering of 10,000,000 shares of common stock, with an additional option for underwriters to purchase up to 1,500,000 shares [1][2][3] Company Overview - MBX Biosciences is a clinical-stage biopharmaceutical company focused on developing precision peptide therapies for endocrine and metabolic disorders, utilizing its proprietary PEP™ platform [6] Offering Details - The public offering price has not yet been determined, and the offering is subject to market conditions [1] - J.P. Morgan, Jefferies, TD Cowen, and Guggenheim Securities are acting as joint book-running managers for the offering, with Citizens Capital Markets and Oppenheimer & Co. as co-lead managers [2] - The registration statement has been filed with the SEC but is not yet effective, meaning securities cannot be sold until it becomes effective [3] Prospectus Information - The proposed offering will be made only by means of a prospectus, which can be obtained from the respective financial institutions involved in the offering [4]

Core Insights - Guggenheim maintains a "Buy" rating for MBX Biosciences, raising the price target from $44 to $84, while the stock was priced at $10 at the time of the report [1][5] - MBX's treatment, Canvuparatide, has shown promising results in clinical trials, achieving a 63% responder rate at 12 weeks and a 79% rate at 6 months [2][5] - The stock price of MBX has surged by 105.05%, currently priced at $20.51, reflecting strong investor confidence [3][5] Company Performance - MBX's market capitalization is approximately $688.84 million, with a trading volume of 19,500,369 shares [4] - The company is preparing for a Phase 3 trial in 2026, which is a key factor contributing to its market position [4] - The stock has fluctuated between $20 and $26.45, with a 52-week high of $27.50 and a low of $4.81 [3]

Group 1 - U.S. stocks showed mixed performance, with the Dow Jones index declining over 100 points on Monday [1] - PROS Holdings, Inc. shares surged 40% to $22.97 following the announcement of its acquisition by Thoma Bravo [1] - MBX Biosciences, Inc. saw a significant increase of 144% to $24.40 after its once-weekly Canvuparatide met primary endpoints in a Phase 2 trial [3] - Metsera, Inc. gained 62.8% to $54.25 amid reports of a near acquisition deal with Pfizer [3] - Anywhere Real Estate Inc. experienced a 57% rise to $11.13 due to a combination announcement with Compass in an all-stock transaction [3] - The ODP Corporation's shares increased by 33.6% to $27.82 after announcing a definitive agreement to be acquired by an affiliate of Atlas Holdings [3] - Banco BBVA Argentina S.A. shares rose 17.7% to $9.64 following U.S. Treasury Secretary Bessent's statement of support for Argentina [3] - Grupo Supervielle S.A. also saw a 16% increase to $5.83 under similar circumstances regarding U.S. support for Argentina [3] - Lumen Technologies, Inc. rose 12.5% to $6.43 after announcing significant progress in building infrastructure for the AI economy [3] - IREN Limited gained 10.7% to $42.88 after doubling its AI Cloud capacity to 23,000 GPUs [3]

Summary of MBX Biosciences Conference Call - September 22, 2025 Company Overview - **Company**: MBX Biosciences - **Ticker**: NasdaqGS:MBX - **Focus**: Development of once-weekly candiparatide for the treatment of hypoparathyroidism (HP) Key Industry Insights - **Hypoparathyroidism**: A chronic condition affecting over 250,000 people in the U.S. and EU combined, primarily caused by a deficiency of parathyroid hormone (PTH) due to surgical removal of parathyroid glands [6][7] - **Market Opportunity**: The U.S. and EU represent a multibillion-dollar market opportunity for treatments addressing HP [30] Core Findings from AVAIL Phase II Clinical Trial - **Positive Results**: The trial demonstrated that 63% of patients receiving once-weekly candiparatide achieved the primary composite endpoint at week 12, compared to 31% on placebo, indicating a statistically significant difference [5][15] - **High Patient Retention**: 94% of patients completed the 12-week study and chose to continue into the open-label extension, reflecting strong patient enthusiasm for the treatment [5][19] - **Durability of Response**: In the ongoing open-label extension, responder rates increased to 79% at six months, suggesting potential durability of the treatment effect [19] - **Calcium Balance Restoration**: Urine calcium excretion was reduced in candiparatide-treated patients, indicating the therapy's ability to help restore calcium balance [6][18] Safety Profile - **Well Tolerated**: Once-weekly candiparatide was well tolerated, with no treatment-related serious adverse events or discontinuations reported during the 12-week trial [6][25] - **Adverse Events**: Commonly reported adverse events included headaches, hypercalcemia, arthralgia, and nausea, with hypercalcemia occurring in approximately 13% to 31% of patients depending on the dose [26][27] Future Development Plans - **Phase III Preparation**: The company plans to schedule an end-of-Phase II meeting with the FDA and begin dosing patients in a global Phase III registration trial in 2026 [31][32] - **Upcoming Presentations**: Data will be presented at the International Hypoparathyroidism Conference in October 2025 and at a major medical conference [31] Additional Considerations - **Patient-Centric Approach**: The once-weekly dosing regimen is expected to be preferred by both healthcare providers and patients due to its convenience compared to daily injections [30][31] - **Sensitivity Analysis**: A sensitivity analysis indicated that excluding patients with higher baseline PTH levels resulted in a placebo response of 15%, reinforcing the efficacy of candiparatide [38] Conclusion - **Best-in-Class Potential**: The results from the AVAIL Phase II trial strongly support the potential of once-weekly candiparatide to become a new standard of care for patients with hypoparathyroidism, addressing significant unmet medical needs in this patient population [28][30]

Phase 2 Trial and Open-Label Extension Top-Line Results: Once-Weekly Canvuparatide in Adults with Hypoparathyroidism September 22, 2025 Disclaimer This presentation includes forward looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our product candidates, preclinical study and/or clinical trial timelines, including projected data announcements, future results of operations and financial position, strategy and plans, in ...