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MBX Biosciences, Inc.

For the period ended Jun 30, 2026. Filed Aug 6, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 6, 2026

MBX$51.35+6.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-07.

0001193125-26-210593

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-06.

0001193125-26-336849

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 141 previous paragraphs and 148 current paragraphs.

112 unchanged; 22 reworded; 7 added; 7 removed; 0 previous and 7 current paragraphs rearranged.

Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (7)

Current report

Our lead product candidate, canvuparatide (MBX 2109), is a parathyroid hormone peptide prodrug that is designed as a potential long-acting hormone replacement therapy for the treatment of chronic hypoparathyroidism. We completed an End of Phase 2 meeting with the U.S. Food and Drug Administration ("FDA") and Scientific Advice with the European Medicines Agency in the first quarter of 2026. In June 2026, we presented results from our Phase 2 clinical trial and reported one-year follow-up data from our ongoing open-label extension study during the Endocrine Society’s ENDO 2026 annual meeting. [We plan to initiate a Phase 3 clinical trial of canvuparatide in the third quarter of 2026]. Our lead obesity product candidate, MBX 4291, is designed to be a long-acting and highly potent glucagon-like peptide 1 ("GLP-1") / glucose-dependent insulinotropic polypeptide ("GIP") co-agonist prodrug with the goal of potential once-monthly dosing frequency and improved efficacy and tolerability relative to existing standards of care. We are conducting a randomized, double-blind, placebo controlled Phase 1 clinical trial designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of SAD and MAD doses in adults with obesity. Results from the first cohort of the 12-week MAD portion of the Phase 1 clinical trial are expected in the fourth quarter of 2026. We have also announced the nomination of our two prodrug development candidates for the treatment of obesity, MBX 5765 and MBX 6180, each enabled by our PEP™ platform. MBX 5765 combines GLP-1, GIP, glucagon ("GCG") and dual amylin and calcitonin receptor agonists ("DACRA") activity in a single construct. MBX 6180 combines GLP-1, GIP and GCG receptor agonist activity in a single construct. We expect to present preclinical data from MBX 6180 at a scientific meeting in the fourth quarter of 2026. IND-enabling studies for both development candidates are ongoing. Our candidate imapextide (MBX 1416) was designed to be a long-acting GLP-1 receptor antagonist as a potential therapy for post-bariatric hypoglycemia, a chronic complication of bariatric surgery. In May 2026, we announced that once-weekly imapextide achieved proof of concept in PBH based on preliminary results from our Phase 2a STEADI™ trial. Given our growing number of novel peptide-based drug candidates and our expanding obesity pipeline, we will not be committing further investment toward a Phase 2b clinical trial of imapextide.

Current report

Research and development expenses were $49.5 million for the six months ended June 30, 2026 as compared to $40.1 million for the six months ended June 30, 2025. The increase of $9.3 million consisted of the following:

Current report

We are also a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act. As a result, we may take advantage of certain of the scaled disclosures available to smaller reporting companies. These include, but are not limited to, reduced disclosure obligations regarding executive compensation and an exemption from the requirement to provide a compensation discussion and analysis describing compensation practices and procedures. As a smaller reporting company with annual revenues of less than $100.0 million and a non-accelerated filer, we are also not required to provide an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. We will be able to take advantage of these scaled disclosures and exemptions for so long as (i) our voting and non-voting shares held by non-affiliates is less than $250.0 million measured on the last business day of our most recent second fiscal quarter or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting shares held by non-affiliates is less than $700.0 million measured on the last business day of our most recent second fiscal quarter.

Current report

As of June 30, 2026, the aggregate market value of our common shares held by non-affiliates exceeded $700.0 million. We may continue to take advantage of certain reduced disclosures available to smaller reporting companies through the filing of our Annual Report on Form 10-K for the year ending December 31, 2026 and we will not be required to provide an attestation report on internal control over financial reporting issued by our independent registered public accounting firm until the filing of our Annual Report on Form 10-K for the year ending December 31, 2027.
Removed paragraphs (7)

Previous report

Our lead product candidate, canvuparatide (MBX 2109), is a parathyroid hormone ("PTH") peptide prodrug that is designed as a potential long-acting hormone replacement therapy for the treatment of chronic hypoparathyroidism ("HP"). Leveraging our proprietary PEP™ platform, we designed canvuparatide to treat the underlying pathophysiology of HP by providing a continuous, infusion-like exposure to PTH, with convenient once-weekly administration. In a Phase 1 clinical trial, canvuparatide demonstrated a low ratio between the highest concentration of active drug observed after a dose and the concentration of active drug observed immediately prior to the next dose ("peak-to-trough ratio"). This result is consistent with a continuous, infusion-like profile, and an extended half-life, potentially enabling the first once-weekly PTH dosing regimen for patients with HP. Canvuparatide was generally well-tolerated with no drug-related severe or serious adverse effects. In a Phase 2 clinical trial of 64 patients with HP, canvuparatide achieved the primary endpoint with a statistically significant responder rate at Week 12 and further demonstrated positive six-month responder results from the open-label extension portion of the trial. All patients completed the 12-week trial, and canvuparatide was generally well-tolerated, with no treatment-related serious adverse events or discontinuations. We completed an End of Phase 2 meeting with the U.S. Food and Drug Administration ("FDA") and Scientific Advice with the European Medicines Agency in the first quarter of 2026. We also intend to present results from our Phase 2 clinical trial and report one-year follow-up data from our ongoing open-label extension study during the Endocrine Society’s ENDO 2026 annual meeting in June 2026; and initiate a Phase 3 clinical trial of canvuparatide in the third quarter of 2026.

Previous report

Our lead obesity product candidate, MBX 4291, is designed to be a long-acting and highly potent "PEP™glucagon-like peptide 1 ("GLP-1") / glucose-dependent insulinotropic polypeptide ("GIP") co-agonist prodrug with the goal of potential once-monthly dosing frequency and improved efficacy and tolerability relative to existing standards of care. In our preclinical studies, the active component of MBX 4291 demonstrated a similar activity profile and body weight loss in mice as tirzepatide, an approved weekly GLP-1/GIP co-agonist, and an extended duration of action of the active component of MBX 4291, supporting the potential for once-monthly administration. The results observed from our preclinical studies may not necessarily be predictive of the results of later-stage clinical trials that we may conduct. We are conducting a randomized, double-blind, placebo controlled Phase 1 clinical trial designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of SAD and MAD doses in adults with obesity. Following the SAD and four-week MAD portions of the trial, we plan to evaluate multiple ascending doses of MBX 4291, or matching placebo, administered over 12 weeks in up to two cohorts consisting of 30 participants. Results from the planned 12-week MAD portion are expected in the fourth quarter of 2026. Beyond MBX 4291, we have a robust discovery pipeline including multiple programs in the lead optimization stage of development, and we expect to nominate two additional candidates in the second and third quarters of 2026.

Previous report

Our program, imapextide (MBX 1416), is designed to be a long-acting GLP-1 receptor antagonist as a potential therapy for post-bariatric hypoglycemia ("PBH"), a chronic complication of bariatric surgery. Imapextide is designed as a convenient once-weekly therapy to reduce insulin secretion and increase blood glucose to reduce the frequency and severity of hypoglycemic events. In January 2025, we announced positive topline results from our Phase 1 SAD and MAD clinical trial of imapextide in healthy adult volunteers. Results from the Phase 1 clinical trial demonstrated dose-proportional increases in imapextide exposure, a median half-life of 90 hours, which is supportive of a once-weekly dosing regimen, and, at steady state, the median Tmaxwas between 36 and 48 hours. Imapextide was generally well-tolerated with a favorable safety profile and no treatment-related serious adverse events. We are conducting the STEADI™ Phase 2a, an open-label clinical trial evaluating primary efficacy of subcutaneous imapextide in adult patients with PBH. Topline results are expected in the second quarter of 2026.

Previous report

(1) Prior period amounts for MBX 4291 have been reclassified to conform to current period presentation.

Previous report

We are also a “smaller reporting company,” meaning that the market value of our shares held by nonaffiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our shares held by nonaffiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our shares held by nonaffiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our 2025 Annual Report and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Reworded paragraphs (22)

Previous wording

Since our inception, we have devoted substantially all of our resources to drug discovery and development of our product candidates, canvuparatide, imapextide and MBX 4291, and other preclinical programs, building our intellectual property portfolio, organizing and staffing our company, business planning, raising capital and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated any revenue from product sales. In September 2024, we completed our initial public offering (the "IPO"), pursuant to which we issued and sold 11,730,000 shares of common stock (inclusive of 1,530,000 shares of commons stock sold pursuant to the underwriters' exercise of their option to purchase additional shares). The aggregate net proceeds received by us from the IPO were $170.5 million, after deducting underwriting discounts and commissions and other offering costs of $17.2 million. In September 2025, we completed an underwritten public offering (the "September 2025 Offering") of 11,108,055 shares of our common stock, which generated approximately $187.4 million in aggregate net proceeds, after deducting underwriting discounts and commissions and other offering costs of $12.5 million. In February 2026, we sold 2,250,986 shares of our common stock under our Open Market Sale Agreement SM with Jefferies, LLC (the "February 2026 ATM Offering"), which generated approximately $87.1 million in aggregate gross proceeds. We have historically funded our operations primarily from the issuance and sale of our common stock, convertible preferred stock and convertible notes, which have generated approximately $688.8 million in cumulative, aggregate gross proceeds to date. In March 2026, we filed an automatic shelf registration statement with the Securities and Exchange Commission (File No. 333-294237) and increased the amount available under the Open Market Sales Agreement SM with Jefferies, LLC (the "March 2026 Sales Agreement"), under which we may now, from time to time in one or more offerings, sell and issue shares of our common stock having an aggregate price of up to $250.0 million.

Current wording

Since our inception, we have devoted substantially all of our resources to drug discovery and development of our product candidates, canvuparatide, imapextide, MBX 4291 and other preclinical programs, building our intellectual property portfolio, organizing and staffing our company, business planning, raising capital and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated any revenue from product sales. In September 2024, we completed our initial public offering (the "IPO"), pursuant to which we issued and sold 11,730,000 shares of common stock (inclusive of 1,530,000 shares of commons stock sold pursuant to the underwriters' exercise of their option to purchase additional shares). The aggregate net proceeds received by us from the IPO were $170.5 million, after deducting underwriting discounts and commissions and other offering costs of $17.2 million. In September 2025, we completed an underwritten public offering (the "September 2025 Offering") of 11,108,055 shares of our common stock, which generated approximately $187.4 million in aggregate net proceeds, after deducting underwriting discounts and commissions and other offering costs of $12.5 million. In February 2026, we sold 2,250,986 shares of our common stock under our Open Market Sale Agreement SM with Jefferies, LLC (the "February 2026 ATM

Previous wording

We have incurred significant operating losses since inception and we expect to continue to incur substantial losses for the foreseeable future. Our ability to generate revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Our net losses were $23.5 million and $23.9 million for the three months ended March 31, 2026 and 2025, respectively. We had an accumulated deficit of $248.0 million and $224.5 million as of March 31, 2026 and December 31, 2025, respectively.

Current wording

We have incurred significant operating losses since inception and we expect to continue to incur substantial losses for the foreseeable future. Our ability to generate revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Our net losses were $60.6 million and $43.3 million for the six months ended June 30, 2026 and 2025, respectively. We had an accumulated deficit of $285.1 million and $224.5 million as of June 30, 2026 and December 31, 2025, respectively.

Previous wording

advance the development of our lead product candidates, canvuparatide, imapextide and MBX 4291, and future product candidates;

Current wording

advance the development of our lead product candidates, canvuparatide, MBX 4291, MBX 5765 and MBX 6180, and future product candidates;

Previous wording

We had cash, cash equivalents and marketable securities of $440.0 million and $373.7 million as of March 31, 2026 and December 31, 2025, respectively. We believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Liquidity and capital resources” herein and “Risk Factors—Risks related to financial position and need for capital” from Item 1A Risk Factors in our Annual Report.

Current wording

We had cash, cash equivalents and marketable securities of $418.6 million and $373.7 million as of June 30, 2026 and December 31, 2025, respectively. We believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Liquidity and capital resources” herein and “Risk Factors—Risks related to financial position and need for capital” from Item 1A Risk Factors in our Annual Report.

Previous wording

In June 2020, we entered into an Exclusive License Agreement with Indiana University Research and Technology Corporation ("IURTC"), a non-profit corporation organized under the laws of the State of Indiana, represented by The Trustees of Indiana University ("IU"), pursuant to which we have been granted an exclusive, royalty-bearing license to certain IURTC patent rights ("the Licensed Intellectual Property") developed by Dr. DiMarchi and other collaborators to further scientific research, for new product development, and for other applications in public interest, such license, the IURTC License Agreement. In particular, we have been granted an exclusive, royalty-bearing license to make, have made, use, have used, offer to sell, have offered for sale, sell, have sold, import and have imported products that are covered by the Licensed Intellectual Property ("Licensed Products"), with the right to sublicense to third parties. IURTC and IU have retained the right to (i) practice and use the Licensed Intellectual Property for non-commercial educational, research, and patient care and treatment purposes, and (ii) permit other non-profit and academic entities to practice and use the Licensed Intellectual Property for the same non-commercial purposes. Under the IURTC License Agreement, we agreed to use commercially reasonable efforts to develop, promote and sell Licensed Products in accordance with the IURTC License Agreement and any applicable laws. The IURTC License Agreement leverages IURTC’s expertise in peptide therapies as well as our scientific, clinical, and regulatory capabilities to accelerate the development of peptide treatments for people with endocrine and metabolic disorders. Canvuparatide (MBX 2109), imapextide (MBX 1416) and MBX 4291 are Licensed Products under the IURTC License Agreement. Any future product candidates developed pursuant to our sponsored research agreement with IU or otherwise covered by the Licensed Intellectual Property may be subject to the IURTC License Agreement.

Current wording

In June 2020, we entered into an Exclusive License Agreement with Indiana University Research and Technology Corporation ("IURTC"), a non-profit corporation organized under the laws of the State of Indiana, represented by The Trustees of Indiana University ("IU"), pursuant to which we have been granted an exclusive, royalty-bearing license to certain IURTC patent rights ("the Licensed Intellectual Property") developed by Dr. DiMarchi and other collaborators to further scientific research, for new product development, and for other applications in public interest, such license, the IURTC License Agreement. In particular, we have been granted an exclusive, royalty-bearing license to make, have made, use, have used, offer to sell, have offered for sale, sell, have sold, import and have imported products that are covered by the Licensed Intellectual Property ("Licensed Products"), with the right to sublicense to third parties. IURTC and IU have retained the right to (i) practice and use the Licensed Intellectual Property for non-commercial educational, research, and patient care and treatment purposes, and (ii) permit other non-profit and academic entities to practice and use the Licensed Intellectual Property for the same non-commercial purposes. Under the IURTC License Agreement, we agreed to use commercially reasonable efforts to develop, promote and sell Licensed Products in accordance with the IURTC License Agreement and any applicable laws. The IURTC License Agreement leverages IURTC’s expertise in peptide therapies as well as our scientific, clinical, and regulatory capabilities to accelerate the development of peptide treatments for people with endocrine and metabolic disorders. Canvuparatide (MBX 2109), imapextide (MBX 1416), MBX 4291, MBX 5765 and MBX 6180 are Licensed Products under the IURTC License Agreement. Any future product candidates developed pursuant to our sponsored research agreement with IU or otherwise covered by the Licensed Intellectual Property may be subject to the IURTC License Agreement.

Previous wording

On January 5, 2024, we and IURTC entered into a fourth amendment to the IURTC License Agreement (the "Fourth Amendment"). The Fourth Amendment specifies IURTC is entitled to the receipt of additional clinical and regulatory milestones, as defined in the Fourth Amendment, up to an aggregate of $9.0 million. Following the execution of the Fourth Amendment, future remaining clinical and regulatory milestone payments in the IURTC License Agreement and all amendments total up to $9.3 million. In 2025, we paid a $1.0 million milestone payment to IURTC related to the initiation of the Phase 1 clinical trial of MBX 4291. In the three months ended March 31, 2026, we triggered a $0.1 million milestone payment to IURTC following the completion of the end of Phase 2 meeting with the FDA related to the Phase 2 clinical trial of canvuparatide, which was included in accrued expenses in the condensed balance sheet as of March 31, 2026 and was paid in the second quarter of 2026. As of March 31, 2026, future remaining clinical and regulatory milestone payments in the IURTC License Agreement and all amendments totaled up to $8.2 million.

Current wording

On January 5, 2024, we and IURTC entered into a fourth amendment to the IURTC License Agreement (the "Fourth Amendment"). The Fourth Amendment specifies IURTC is entitled to the receipt of additional clinical and regulatory milestones, as defined in the Fourth Amendment, up to an aggregate of $9.0 million. Following the execution of the Fourth Amendment, future remaining clinical and regulatory milestone payments in the IURTC License Agreement and all amendments total up to $9.3 million. In 2025, we paid a $1.0 million milestone payment to IURTC related to the initiation of the Phase 1 clinical trial of MBX 4291. In the first quarter of 2026, we triggered a $0.1 million milestone payment to IURTC following the completion of the end of Phase 2 meeting with the FDA related to the Phase 2 clinical trial of canvuparatide, which was paid in the second quarter of 2026. As of June 30, 2026, future remaining clinical and regulatory milestone payments in the IURTC License Agreement and all amendments totaled up to $8.2 million.

Previous wording

Research and development expenses were $18.5 million for the three months ended March 31, 2026, as compared to $22.4 million for the three months ended March 31, 2025. The decrease of $3.9 million consisted of the following:

Current wording

Research and development expenses were $31.0 million for the three months ended June 30, 2026, as compared to $17.7 million for the three months ended June 30, 2025. The increase of $13.3 million consisted of the following:

Previous wording

General and administrative expenses were $8.8 million for the three months ended March 31, 2026, as compared to $4.1 million for the three months ended March 31, 2025. The increase of $4.7 million was primarily due to higher personnel-related costs (including stock-based compensation) resulting from continued expansion of our infrastructure to support growth in our operations and separation related costs.

Current wording

General and administrative expenses were $9.9 million for the three months ended June 30, 2026, as compared to $4.1 million for the three months ended June 30, 2025. The increase of $5.9 million was primarily due to higher personnel-related costs (including stock-based compensation) resulting from continued expansion of both our executive leadership team and general infrastructure to support growth in our operations.

Previous wording

Interest and other income, net, which includes interest income and amortization of premiums and discounts on our investments in marketable securities, were $3.7 million for the three months ended March 31, 2026, as compared to $2.6 million for the three months ended March 31, 2025. The increase of $1.1 million was due to increased interest on our cash, cash equivalents and marketable securities, which increased primarily due to the September 2025 Offering and the February 2026 ATM Offering.

Current wording

Interest and other income, net, which includes interest income and amortization of premiums and discounts on our investments in marketable securities, were $3.8 million for the three months ended June 30, 2026, as compared to $2.4 million for the three months ended June 30, 2025. The increase of $1.4 million was due to increased interest on our cash, cash equivalents and marketable securities, which increased primarily due to the September 2025 Offering and the February 2026 ATM Offering.

Previous wording

Direct research and development program expenses related to canvuparatide decreased by $0.2 million, primarily due to substantially all activity related to the conduct of the Phase 2 clinical trial being completed in 2025, offset by increased manufacturing in preparation for the Phase 3 clinical trial. Direct program expenses for MBX 4291 decreased by $3.8 million primarily due to the timing of preclinical studies and manufacturing activities, partially offset by the ongoing conduct of the Phase 1 clinical trial of MBX 4291. Direct program expenses related to imapextide decreased by $0.9 million, primarily due to the timing of preclinical studies as compared to the first quarter of 2025. Direct program expenses for preclinical and other programs increased by $0.1 million primarily due to pipeline candidate development activities. Personnel-related costs (including stock-based compensation), increased by $1.8 million, primarily due to increased headcount and stock-based compensation expense. Facility-related and other expenses, which include allocated overhead, including rent, repairs and maintenance costs, common facilities and information technology-related expenses allocated to research and development decreased by $0.8 million.

Current wording

Direct research and development program expenses related to canvuparatide increased by $4.8 million, primarily due to clinical start-up activity for the Phase 3 clinical trial, manufacturing to support the Phase 3 clinical trial and the ongoing Phase 2 open-label extension clinical trial. Direct program expenses for MBX 4291 increased by $0.7 million primarily due to ongoing conduct of the Phase 1 clinical trial, offset by a decrease in manufacturing costs and preclinical study related expense incurred in the first half of 2025. Direct program expenses for imapextide decreased by $0.8 million primarily due to the Phase 2a STEADI™ clinical trial completing at the beginning of the second quarter of 2026 and the decision to commit no further investment to the program. Direct program expenses for preclinical and other programs remained relatively unchanged. Personnel-related costs (including stock-based compensation) increased by $5.1 million, primarily due to increased headcount and stock-based compensation expense. Facility-related and other expenses, which include allocated overhead, including rent, repairs and maintenance costs, common facilities and information technology-related expenses allocated to research and development decreased by $0.4 million.

Previous wording

Since our inception, we have incurred significant operating losses. We have historically funded our operations primarily through our IPO, the September 2025 Offering, the February 2026 ATM Offering, and sales of our convertible preferred stock and convertible notes, which have generated approximately $688.8 million in cumulative, aggregate gross proceeds. As of March 31, 2026 and December 31, 2025, we had $440.0 million and $262.1 million in cash, cash equivalents and marketable securities, respectively. We have not yet generated any revenue from product sales and do not expect to in the foreseeable future as our product candidates are in various phases of clinical and preclinical development.

Current wording

Since our inception, we have incurred significant operating losses. We have historically funded our operations primarily through our IPO, the September 2025 Offering, the February 2026 ATM Offering, and sales of our convertible preferred stock and convertible notes, which have generated approximately $688.8 million in cumulative, aggregate gross proceeds. As of June 30, 2026 and December 31, 2025, we had $418.6 million and $373.7 million in cash, cash equivalents and marketable securities, respectively. We have not yet generated any revenue from product sales and do not expect to in the foreseeable future as our product candidates are in various phases of clinical and preclinical development.

Previous wording

We had $440.0 million and $262.1 million in cash, cash equivalents and marketable securities as of March 31, 2026 and December 31, 2025, respectively. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our current operating plan for at least the next 12 months from the date of issuance of the accompanying unaudited condensed financial statements. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities will be sufficient to fund our projected operating expenses and capital expenditure requirements into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

Current wording

We had $418.6 million and $373.7 million in cash, cash equivalents and marketable securities as of June 30, 2026 and December 31, 2025, respectively. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our current operating plan for at least the next 12 months from the date of issuance of the accompanying unaudited condensed financial statements. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities will be sufficient to fund our projected operating expenses and capital expenditure requirements into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2026 was $20.2 million. This was primarily due to our net loss of $23.5 million, partially offset by non-cash charges of $5.0 million. Non-cash charges primarily consisted of $5.5 million of stock-based compensation expense and $0.1 million of depreciation expense related to our property and equipment, partially offset by $0.6 million of net amortization and accretion of marketable securities. The changes in our net operating assets and liabilities primarily consisted of a $0.9 million increase in accounts payable and accrued expenses primarily related to balances with CROs and CDMOs and a $0.7 million increase in our prepaid expenses and other current assets related to prepaid balances with CROs and CDMOs.

Current wording

Net cash used in operating activities for the six months ended June 30, 2026 was $42.8 million. This was primarily due to our net loss of $60.6 million, partially offset by non-cash charges of $10.8 million. Non-cash charges primarily consisted of $11.5 million of stock-based compensation expense, $0.1 million of depreciation expense related to our property and equipment and $0.1 million of amortization expense related to our right-of-use assets, partially offset by $1.0 million of net amortization and accretion of marketable securities. The changes in our net operating assets and liabilities primarily consisted of a $7.1 million increase in accounts payable and accrued expenses primarily related to balances with CROs and CDMOs, a $0.5 million decrease in our prepaid expenses and other current assets related to prepaid balances with CROs and CDMOs, and a net increase of $0.3 million related to our operating lease liabilities.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2025 was $22.7 million. This was primarily due to our net loss of $23.9 million, partially offset by net cash provided by changes in our operating assets and liabilities of $0.6 million and non-cash charges of $0.6 million. The changes in our net operating assets and liabilities primarily consisted of a $1.6 million decrease in our prepaid expenses and other current assets related to prepaid balances with CROs, partially offset by a $1.0 million decrease in accounts payable and accrued expenses primarily related to balances with CDMOs. Non-cash charges primarily consisted of $1.8 million of stock-based compensation expense and $0.1 million of depreciation expense, partially offset by $1.3 million of net amortization and accretion of marketable securities.

Current wording

Net cash used in operating activities for the six months ended June 30, 2025 was $40.1 million. This was primarily due to our net loss of $43.3 million, partially offset by net cash provided by changes in our operating assets and liabilities of $1.6 million and non-cash charges of $1.7 million. The changes in our net operating assets and liabilities primarily consisted of a $0.9 million increase in our prepaid expenses and other current assets related to prepaid balances with CROs, a $0.8 million increase in accounts payable and accrued expenses primarily related to balances with CROs. Non-cash charges primarily consisted of $3.8 million of stock-based compensation expense, $0.1 million of depreciation expense related to our property and equipment and $0.1 million of amortization expense related to our right-of-use asset, partially offset by $2.3 million of net amortization and accretion of marketable securities.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2026 was $97.1 million, which consisted of purchases of marketable securities of $154.2 million and purchases of property and equipment of $0.4 million, partially offset by maturities of marketable securities of $57.5 million.

Current wording

Net cash used in investing activities for the six months ended June 30, 2026 was $67.9 million, which consisted of purchases of marketable securities of $208.0 million and purchases of property and equipment of $1.3 million, partially offset by maturities of marketable securities of $141.5 million.

Previous wording

Net cash provided by investing activities for the three months ended March 31, 2025 was $3.2 million, which consisted of maturities of marketable securities of $57.2 million and redemptions of marketable securities of $5.0 million, partially offset by purchases of marketable securities of $58.9 million.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2025 was $29.2 million, which consisted of maturities of marketable securities of $130.3 million and redemptions of marketable securities of $6.0 million, partially offset by purchases of marketable securities of $106.3 million and purchases of property and equipment of $0.8 million.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2026 was $87.4 million, which consisted of proceeds of $85.4 million from the February 2026 ATM Offering, net of underwriting discounts and commissions and $2.4 million of proceeds from the exercise of common stock options, partially offset by payments totaling $0.4 million related to offering costs for the February 2026 ATM Offering.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $89.8 million, which consisted of proceeds of $85.4 million from the February 2026 ATM Offering, net of underwriting discounts and commissions, $4.6 million of proceeds from the exercise of common stock options, and $0.3 million of proceeds from the purchase of shares of our common stock pursuant to the 2026 ESPP, partially offset by payments totaling $0.5 million related to offering costs for the February 2026 ATM Offering.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2025 was immaterial.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2025 was $1.3 million, which consisted of proceeds from the exercise of common stock options.

Previous wording

In February 2026, the Company entered into a lease agreement with 5 Burlington Woods, LLC to lease new office and laboratory space in Burlington, Massachusetts. The lease agreement provides an estimated lease commencement date of May 1, 2026, with the rent commencing five months from the lease commencement date. The lease term will be four years with a one-time option to extend the lease term for a period of three years. The option to extend was not considered reasonably certain as of the lease inception. The aggregate base rent over the four-year lease term is approximately $3.4 million. The Company is evaluating the new lease terms pursuant to ASC 842 and is still assessing the financial statement impact.

Current wording

Additionally, on February 24, 2026, we entered into an operating lease agreement with 5 Burlington Woods, LLC to lease new office and laboratory space in Burlington, Massachusetts ("Burlington Lease"). The lease commenced effective April 14, 2026, with the rent commencing five months from the lease commencement date, which will be September 14, 2026 ("rent commencement date"). The lease term is four years from the rent commencement date, with a one-time option to extend the lease term for a period of three years. The option to extend was not considered reasonably certain as of the lease inception. The aggregate base rent over the four-year lease term is approximately $3.4 million

Previous wording

We have entered into two separate lease agreements for corporate office space and laboratory space, with terms extending through December 2028 and December 2025, respectively. The lease for our corporate office space was amended in May 2025 as further discussed in Note 9 to our interim unaudited condensed financial statements included elsewhere in this Quarterly Report. As of March 31, 2026, our future remaining operating lease payments were $0.7 million, with $0.2 million payable within the next twelve months, with respect to leases already commenced as of such date. As of December 31, 2025, our future remaining operating lease payments were $0.7 million, with $0.2 million payable within the next twelve months, with respect to leases already commenced as of such date.

Current wording

As of June 30, 2026, our future remaining operating lease payments were $4.0 million, with $0.9 million payable within the next twelve months, with respect to leases already commenced as of such date. As of December 31, 2025, our future remaining operating lease payments were $0.7 million, with $0.2 million payable within the next twelve months, with respect to leases already commenced as of such date.

Previous wording

During the three months ended March 31, 2026, there were no material changes to our critical accounting policies and estimates described under Management’s Discussion and Analysis of Critical Accounting Policies and Estimates which are included in our 2025 Annual Report.

Current wording

During the six months ended June 30, 2026, there were no material changes to our critical accounting policies and estimates described under Management’s Discussion and Analysis of Critical Accounting Policies and Estimates which are included in our 2025 Annual Report.

Previous wording

We qualify as an “emerging growth company,” as defined in the JOBS Act. As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include: (i) being permitted to present only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s discussion and analysis of financial condition and results of operations” disclosure in this Quarterly Report; (ii) reduced disclosure about our executive compensation arrangements; (iii) not being required to hold advisory votes on executive compensation or to obtain stockholder approval of any golden parachute arrangements not previously approved; (iv) an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002; and (v) an exemption from compliance with the requirements of the Public Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s report on the financial statements.

Current wording

We currently qualify as an “emerging growth company,” as defined in the JOBS Act. As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include: (i) being permitted to present only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s discussion and analysis of financial condition and results of operations” disclosure in this Quarterly Report; (ii) reduced disclosure about our executive compensation arrangements; (iii) not being required to hold advisory votes on executive compensation or to obtain stockholder approval of any golden parachute arrangements not previously approved; (iv) an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002; and (v) an exemption from compliance with the requirements of the Public Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s report on the financial statements.
Rearranged current paragraphs (7)

Current report — wording carried from elsewhere

Offering"), which generated approximately $87.1 million in aggregate gross proceeds. We have historically funded our operations primarily from the issuance and sale of our common stock, convertible preferred stock and convertible notes, which have generated approximately $688.8 million in cumulative, aggregate gross proceeds to date. In March 2026, we filed an automatic shelf registration statement with the Securities and Exchange Commission (File No. 333-294237) and increased the amount available under the Open Market Sales Agreement SM with Jefferies, LLC (the "March 2026 Sales Agreement"), under which we may now, from time to time in one or more offerings, sell and issue shares of our common stock having an aggregate price of up to $250.0 million.

Current report — wording carried from elsewhere

Direct research and development program expenses related to canvuparatide increased by $5.0 million, primarily due to clinical start-up activity for the Phase 3 clinical trial, clinical supply manufacturing to support the Phase 3 clinical trial and the ongoing Phase 2 open-label extension clinical trial. Direct program expenses for MBX 4291 increased by $4.5 million primarily due to ongoing conduct of the Phase 1 clinical trial. Direct program expenses for imapextide and preclinical and other programs remained relatively unchanged. Personnel-related costs (including stock-based compensation) increased by $3.4 million, primarily due to increased headcount and stock-based compensation expense. Facility-related and other expenses, which include allocated overhead, including rent, repairs and maintenance costs, common facilities and information technology-related expenses allocated to research and development increased by $0.4 million.

Current report — wording carried from elsewhere

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):

Current report — wording carried from elsewhere

The following table summarizes our research and development expenses for the periods indicated (in thousands):

Current report — wording carried from elsewhere

General and administrative expenses were $18.7 million for the six months ended June 30, 2026, as compared to $8.2 million for the six months ended June 30, 2025. The increase of $10.5 million was primarily due to higher personnel-related costs (including stock-based compensation) resulting from continued expansion of both our executive leadership team and general infrastructure to support growth in our operations and separation related costs.

Current report — wording carried from elsewhere

Interest and other income, net, which includes interest income and amortization of premiums and discounts on our investments in marketable securities, were $7.6 million for the six months ended June 30, 2026, as compared to $5.0 million for the six months ended June 30, 2025. The increase of $2.5 million was due to increased interest on our cash, cash equivalents and marketable securities, which increased primarily due to the September 2025 Offering and the February 2026 ATM Offering.

Current report — wording carried from elsewhere

We have entered into two separate lease agreements for corporate office space and laboratory space, with terms extending through December 2028 and December 2025, respectively. The lease for our corporate office space was amended in May 2025 as further discussed in Note 9 to our interim unaudited condensed financial statements included elsewhere in this Quarterly Report.