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MBX Biosciences, Inc.

For the period ended Jun 30, 2025. Filed Aug 7, 2025.

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, 2025 · Filed Aug 7, 2025

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 2025-03-31; filed 2025-05-12.

0000950170-25-068602

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

Current report: 10-Q

Period ended 2025-06-30; filed 2025-08-07.

0000950170-25-104619

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 139 previous paragraphs and 148 current paragraphs.

110 unchanged; 25 reworded; 8 added; 3 removed; 1 previous and 5 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 (8)

Current report

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

Current report

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

Current report

Research and development expenses were $40.1 million for the six months ended June 30, 2025, as compared to $25.4 million for the six months ended June 30, 2024. The increase of $14.7 million consisted of the following:

Current report

Net cash used in financing activities for the six months ended June 30, 2024 was $1.6 million, which consisted of payments of offering costs related to our IPO of $1.8 million, partially offset by $0.2 million in proceeds from the exercise of common stock options.
Removed paragraphs (3)
Reworded paragraphs (25)

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q (this "Quarterly Report") and with our audited financial statements and the related notes for the year ended December 31, 2024 and the related Management's Discussion and Analysis of Financial Condition and Results of Operation, both of which are included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on March 17, 2025 (our "Annual Report"). This discussion and other parts of this Quarterly Report contain forward-looking statements that involve risks and uncertainties, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the “Risk Factors” section of this Quarterly Report. You should carefully read the "Risk Factors" section of this Quarterly Report to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see "Special Note Regarding Forward-Looking Statements". Our historical results are not necessarily indicative of the results that may be expected for any period in the future.

Current wording

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q (this "Quarterly Report") and with our audited financial statements and the related notes for the year ended December 31, 2024 and the related Management's Discussion and Analysis of Financial Condition and Results of Operation, both of which are included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on March 17, 2025 (our "2024 Annual Report"). This discussion and other parts of this Quarterly Report contain forward-looking statements that involve risks and uncertainties, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the “Risk Factors” section of this Quarterly Report. You should carefully read the "Risk Factors" section of this Quarterly Report to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see "Special Note Regarding Forward-Looking Statements". Our historical results are not necessarily indicative of the results that may be expected for any period in the future.

Previous wording

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, ("HP"). Leveraging our proprietary PEP platform, we designed canvuparatide to treat the underlying pathophysiology of HP by providing a continuous, infusion-like exposure to parathyroid hormone, ("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"), which 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. We are currently evaluating canvuparatide in a Phase 2 clinical trial in patients with HP. In March 2025, we announced completion of enrollment of 64 patients and we anticipate reporting topline data in the third quarter of 2025.

Current wording

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, ("HP"). Leveraging our proprietary PEP platform, we designed canvuparatide to treat the underlying pathophysiology of HP by providing a continuous, infusion-like exposure to parathyroid hormone, ("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"), which 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. We are currently evaluating canvuparatide in a Phase 2 clinical trial in 64 patients with HP. In March 2025, we announced completion of enrollment, and we anticipate reporting topline data in the third quarter of 2025.

Previous wording

Our second program is MBX 1416, which is designed to be a long-acting glucagon-like peptide-1, ("receptor antagonist"), as a potential therapy for post-bariatric hypoglycemia, ("PBH"), a chronic complication of bariatric surgery. MBX 1416 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 our ongoing Phase 1 clinical trial, the single ascending dose ("SAD") portion of this Phase 1 trial evaluates subcutaneous MBX 1416 doses of 10 milligrams (“mg”), 30 mg, 100 mg and 200 mg, in up to eight healthy adults per cohort randomized 3:1 (six MBX 1416; two placebo in each cohort). The multiple ascending dose ("MAD") portion of the trial evaluates four weekly subcutaneous doses of placebo and 10 mg, 30 mg (as two injections) and 30 mg (as one injection) MBX 1416 in three cohorts in up to eight healthy adults per cohort (six MBX 1416; two placebo in each cohort). An additional cohort will assess the clinical relevance of preclinical transporter findings. Preliminary data regarding the way the compound is absorbed, distributed, metabolized and excreted, ("pharmacokinetics") from the single ascending dose portion demonstrated that weekly subcutaneous injections resulted in dose-proportional increases in MBX 1416 exposure and a half-life supporting a once-weekly dosing regimen. In January 2025, we announced positive topline results from our Phase 1 SAD and MAD clinical trial of MBX 1416 in healthy adult volunteers. A Phase 2 clinical trial of MBX 1416 in patients with PBH is anticipated to initiate in the second half of 2025 following completion of an End-of-Phase 1 meeting with U.S. Food and Drug Administration ("FDA").

Current wording

Our second program is imapextide (MBX 1416), which is designed to be a long-acting glucagon-like peptide-1 ("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. The single ascending dose ("SAD") portion of this Phase 1 trial evaluated subcutaneous imapextide doses of 10 milligrams (“mg”), 30 mg, 100 mg and 200 mg, in up to eight healthy adults per cohort randomized 3:1 (six imapextide; two placebo in each cohort). The multiple ascending dose ("MAD") portion of the trial evaluated four weekly subcutaneous doses of placebo and 10 mg, 30 mg (as two injections) and 30 mg (as one injection) imapextide in three cohorts in up to eight healthy adults per cohort (six imapextide; two placebo in each cohort). An additional cohort assessed the clinical relevance of preclinical transporter findings. 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 Tmax was between 36 and 48 hours. Imapextide was generally well-tolerated with a favorable safety profile and no treatment-related serious adverse events. We completed an End-of-Phase 1 meeting with U.S. Food and Drug Administration ("FDA"), and a Phase 2a clinical trial evaluating imapextide in patients with PBH is anticipated to initiate in the third quarter of 2025.

Previous wording

Our third program is our lead obesity product candidate, MBX 4291, which is designed to be a long-acting and highly potent and glucose-dependent insulinotropic polypeptide receptor prodrug with the goal of potential once monthly dosing frequency and improving efficacy and tolerability relative to existing standards of care. MBX 4291 is currently being evaluated in preclinical studies, with an anticipated investigational new drug, ("IND") submission in the second quarter of 2025. Beyond MBX 4291, we have a robust discovery pipeline including additional programs in the lead optimization stage for the treatment of obesity and associated comorbidities.

Current wording

Our third program is our lead obesity product candidate, MBX 4291, which is designed to be a long-acting and highly potent GLP-1 and glucose-dependent insulinotropic polypeptide, or GIP, receptor co-agonist prodrug with the goal of potential once monthly dosing frequency and improving efficacy and tolerability relative to existing standards of care. On June 16, 2025, we announced the investigational new drug ("IND") application submission to the FDA for MBX 4291 and, in July 2025, we received clearance to proceed with a Phase 1 clinical trial, which is expected to begin in the third quarter of 2025. Beyond MBX 4291, we have a robust discovery pipeline including multiple programs in the lead optimization stage of development.

Previous wording

Since our inception, we have devoted substantially all of our resources to drug discovery and development of our product candidates, canvuparatide, MBX 1416 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 use from the IPO were $170.5 million, after deducting underwriting discounts and commissions and other offering costs of $17.2 million. We have historically funded our operations primarily from the issuance and sale of our common stock, convertible preferred stock and convertible notes, which generated approximately $401.8 million in aggregate gross proceeds.

Current 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 use from the IPO were $170.5 million, after deducting underwriting discounts and commissions and other offering costs of $17.2 million. We have historically funded our operations primarily from the issuance and sale of our common stock, convertible preferred stock and convertible notes, which generated approximately $401.8 million in aggregate gross proceeds.

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 $23.9 million and $12.3 million for the three months ended March 31, 2025 and 2024, respectively. We had an accumulated deficit of $161.4 million and $137.5 million as of March 31, 2025 and December 31, 2024, 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 $19.4 million and $15.9 million for the three months ended June 30, 2025 and 2024, respectively. Our net losses were $43.3 million and $28.2 million for the six months ended June 30, 2025 and 2024, respectively. We had an accumulated deficit of $180.8 million and $137.5 million as of June 30, 2025 and December 31, 2024, respectively.

Previous wording

advance the development of our lead product candidates, canvuparatide, MBX 1416 and MBX 4291, and future product candidates;

Current wording

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

Previous wording

We had cash, cash equivalents and marketable securities of $240.8 million and $262.1 million as of March 31, 2025 and December 31, 2024, respectively. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into mid-2027. 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 $224.9 million and $262.1 million as of June 30, 2025 and December 31, 2024, respectively. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into mid-2027. 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, or 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), 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, or 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.

Previous wording

Research and development expenses were $22.4 million for the three months ended March 31, 2025, as compared to $11.0 million for the three months ended March 31, 2024. The increase of $11.4 million consisted of the following:

Current wording

Research and development expenses were $17.7 million for the three months ended June 30, 2025, as compared to $14.4 million for the three months ended June 30, 2024. The increase of $3.3 million consisted of the following:

Previous wording

General and administrative expenses were $4.1 million for the three months ended March 31, 2025, as compared to $2.3 million for the three months ended March 31, 2024. The increase of $1.9 million was primarily due to higher professional fees related to legal and accounting services and higher personnel-related costs, including compensation, benefits and stock-based compensation, as we expanded our infrastructure to support growth in our operations.

Current wording

General and administrative expenses were $4.1 million for the three months ended June 30, 2025, as compared to $2.3 million for the three months ended June 30, 2024. The increase of $1.8 million was primarily due to higher professional fees related to legal and accounting services and higher personnel-related costs, including compensation, benefits and stock-based compensation, as we expanded our infrastructure to support growth in our operations as a public company.

Previous wording

Interest and other income, net, which includes interest income and amortization of premiums and discounts on our investments in marketable securities, were $2.6 million for the three months ended March 31, 2025, as compared to $1.0 million for the three months ended March 31, 2024. The increase of $1.7 million was due to increased interest on our cash, cash equivalents and marketable securities, which increased primarily due to our IPO in September 2024 and the Series C Convertible Preferred Stock financing in August 2024.

Current wording

Interest and other income, net, which includes interest income and amortization of premiums and discounts on our investments in marketable securities, were $2.4 million for the three months ended June 30, 2025, as compared to $0.8 million for the three months ended June 30, 2024. The increase of $1.6 million was due to increased interest on our cash, cash equivalents and marketable securities, which increased primarily due to our IPO in September 2024 and the Series C Convertible Preferred Stock financing in August 2024.

Previous wording

Direct research and development program expenses related to canvuparatide increased by $4.4 million, primarily due to the ongoing Phase 2 clinical trial, clinical supply manufacturing costs and costs associated with conducting preclinical studies. Direct program expenses related to MBX 1416 decreased by $0.8 million, primarily due to the completion of the Phase 1 clinical trial in the first quarter of 2025. Direct program expenses for preclinical and other programs increased by $6.1 million primarily due to pipeline candidate development activities, specifically including investigational new drug application ("IND")-enabling preclinical studies and nonclinical and clinical supply manufacturing related to MBX 4291. Personnel-related costs (including stock-based compensation), increased by $1.5 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 $0.2 million.

Current wording

Direct research and development program expenses related to canvuparatide increased by $8.3 million, primarily due to increased activities related to conduct of the Phase 2 clinical trial, clinical supply manufacturing costs and costs associated with conducting preclinical studies. Direct program expenses related to imapextide decreased by $5.0 million, primarily due to the completion of the Phase 1 clinical trial in the first quarter of 2025. Direct program expenses for MBX 4291 increased by $6.2 million, primarily due to preclinical studies and manufacturing activities related to MBX 4291, for which the IND was filed in June 2025. Direct program expenses for preclinical and other programs increased by $2.3 million, primarily due to pipeline candidate development activities. Personnel-related costs (including stock-based compensation), increased by $2.6 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 $0.3 million.

Previous wording

Since our inception, we have incurred significant operating losses. We have historically funded our operations primarily through our IPO and sales of our convertible preferred stock and convertible notes, which have generated approximately $401.8 million in aggregate gross proceeds. As of March 31, 2025 and December 31, 2024, we had $240.8 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 and sales of our convertible preferred stock and convertible notes, which have generated approximately $401.8 million in aggregate gross proceeds. As of June 30, 2025 and December 31, 2024, we had $224.9 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.

Previous wording

We had $240.8 million and $262.1 million in cash, cash equivalents and marketable securities as of March 31, 2025 and December 31, 2024, 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 mid-2027. 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 $224.9 million and $262.1 million in cash, cash equivalents and marketable securities as of June 30, 2025 and December 31, 2024, 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 mid-2027. 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, 2024 was $10.7 million. This was primarily due to our net loss of $12.3 million, partially offset by net cash provided by changes in our operating assets and liabilities of $0.4 million and non-cash charges of $1.2 million. The changes in our net operating assets and liabilities primarily consisted of a $0.4 million decrease in our prepaid expenses and other current assets. Non-cash charges primarily consisted of $1.6 million of stock-based compensation expense, partially offset by $0.5 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 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 related to our property and equipment, 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, 2024 was $24.0 million. This was primarily due to our net loss of $28.2 million, partially offset by net cash provided by changes in our operating assets and liabilities of $2.5 million and non-cash charges of $1.8 million. The changes in our net operating assets and liabilities primarily consisted of a $3.3 million increase in accounts payable and accrued expenses primarily related to balances with CDMOs, partially offset by a $0.8 million decrease in our prepaid expenses and other current assets. Non-cash charges primarily consisted of $2.5 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 asset, partially offset by $0.9 million of net amortization and accretion of marketable securities.

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 investing activities for the three months ended March 31, 2024 was $15.4 million, which consisted of maturities of marketable securities of $24.3 million, partially offset by purchases of marketable securities of $8.5 million and purchases of property and equipment of $0.3 million.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2024 was $7.5 million, which consisted of maturities of marketable securities of $32.5 million, partially offset by purchases of marketable securities of $24.2 million and purchases of property and equipment of $0.7 million.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2024 was $0.2 million, which consisted of proceeds from the exercise of common stock options of $0.2 million.

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

We have entered into two separate lease agreements for corporate office space and laboratory space, with terms extending through December 2025. As of March 31, 2025, our future remaining operating lease payments were $0.1 million, with $0.1 million payable within the next twelve months, with respect to leases already commenced as of such date. As of December 31, 2024, our future remaining operating lease payments were $0.2 million, with $0.2 million payable within the next twelve months, with respect to leases already commenced as of such date.

Current 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 June 30, 2025, our future remaining operating lease payments were $0.8 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, 2024, our future remaining operating lease payments were $0.2 million, with $0.2 million payable within the next twelve months, with respect to leases already commenced as of such date.

Previous wording

Refer to Note 9 and Note 17 in our interim unaudited condensed financial statements included elsewhere in this Quarterly Report for more information on our lease obligations.

Current wording

Refer to Note 9 in our interim unaudited condensed financial statements included elsewhere in this Quarterly Report for more information on our lease obligations.

Previous wording

Under the IURTC License Agreement, we have payment obligations that are contingent upon future events, such as the achievement of specified development, regulatory and commercial milestones, and in some cases, we are required to make royalty payments in connection with the sales of products developed under those agreements. Although we could be required to make milestone payments under the IURTC License Agreement, we are unable to estimate the timing or likelihood of achieving the milestones or making future product sales. For additional details regarding the IURTC License Agreement, see the section herein titled “License agreement” included in our Annual Report.

Current wording

Under the IURTC License Agreement, we have payment obligations that are contingent upon future events, such as the achievement of specified development, regulatory and commercial milestones, and in some cases, we are required to make royalty payments in connection with the sales of products developed under those agreements. Although we could be required to make milestone payments under the IURTC License Agreement, we are unable to estimate the timing or likelihood of achieving the milestones or making future product sales. For additional details regarding the IURTC License Agreement, see the section herein titled “License agreement” included in our 2024 Annual Report.

Previous wording

During the three months ended March 31, 2025, 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 Annual Report.

Current wording

During the six months ended June 30, 2025, 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 2024 Annual Report.

Previous wording

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 Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Current wording

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 2024 Annual Report and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Rearranged current paragraphs (5)

Current report — wording carried from elsewhere

Direct research and development program expenses related to canvuparatide increased by $3.9 million, primarily due to increased activities related to the Phase 2 clinical trial. Direct program expenses related to imapextide decreased by $4.1 million, primarily due to the completion of the Phase 1 clinical trial in the first quarter of 2025. Direct program expenses for MBX 4291 increased by $1.0 million primarily due to preclinical studies and manufacturing activities related to MBX 4291, for which the IND was filed in June 2025. Direct program expenses for preclinical and other programs increased by $1.3 million primarily due to pipeline candidate development activities. Personnel-related costs (including stock-based compensation), increased by $1.1 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 increased by $0.1 million.

Current report — wording carried from elsewhere

The following table summarizes our results of operations for the periods indicated (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 $8.2 million for the six months ended June 30, 2025, as compared to $4.5 million for the six months ended June 30, 2024. The increase of $3.7 million was primarily due to higher professional fees related to legal, insurance and accounting services and higher personnel-related costs, including compensation, benefits and stock-based compensation, as we expanded our infrastructure to support growth in our operations as a public company.

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 $5.0 million for the six months ended June 30, 2025, as compared to $1.8 million for the six months ended June 30, 2024. The increase of $3.2 million was due to increased interest on our cash, cash equivalents and marketable securities, which increased primarily due to our IPO in September 2024 and the Series C Convertible Preferred Stock financing in August 2024.
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Previous report — wording carried elsewhere

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