MBX Biosciences, Inc.

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations together with our 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, 2023 included in our final prospectus dated September 12, 2024, filed with the Securities and Exchange Commission pursuant to rule 424(b) under the Securities Act of 1933, as amended (the "IPO Prospectus"). 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 "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, 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 MBX 2109 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, MBX 2109 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. MBX 2109 was generally well-tolerated with no drug-related severe or serious adverse effects. We are currently evaluating MBX 2109 in a Phase 2 clinical trial in patients with HP and dosed our first patient in this trial in August 2024. Enrollment is ongoing and expected to complete in the first quarter of 2025 and we anticipate reporting top-line 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 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.

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 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 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. We anticipate the last subject visit to occur in late November 2024 and plan to announce the Phase 1 top-line data in early January of 2025.

Current 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").

Previous wording

Our third program is our lead obesity product candidate, MBX 4291, is designed to be a long-acting and highly potent and glucose-dependent insulinotropic polypeptide receptor prodrug with the goal of reducing 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 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.

Previous wording

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, 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.

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 $18.1 million and $10.2 million for the three months ended September 30, 2024 and 2023, respectively. Our net losses were $46.3 million and $23.7 million for the nine months ended September 30, 2024 and 2023, respectively. We had an accumulated deficit of $121.9 million and $75.6 million as of September 30, 2024 and December 31, 2023, 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 $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.

Previous wording

advance the development of our lead product candidates, MBX 2109, MBX 1416 and MBX 4291, and future product candidates;

Current wording

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

Previous wording

We had cash, cash equivalents and marketable securities of $277.1 million and $80.7 million as of September 30, 2024 and December 31, 2023, 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” and “Risk Factors—Risks related to financial position and need for capital.”

Current 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.

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. 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), 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 $16.7 million for the three months ended September 30, 2024, as compared to $9.1 million for the three months ended September 30, 2023. The increase of $7.7 million consisted of the following:

Current 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:

Previous wording

Direct research and development program expenses related to MBX 2109 increased by $3.0 million, primarily due to the ongoing Phase 2 clinical trial and costs associated with conducting preclinical studies. Direct program expenses related to MBX 1416 decreased by $2.1 million, primarily due to the timing of costs associated with conducting preclinical studies, partially offset by an increase in costs associated with conduct of the Phase 1 clinical trial. Direct program expenses for preclinical and other programs increased by $5.3 million primarily due to pipeline candidate development activities, specifically including investigational new drug application ("IND")-enabling preclinical studies related to MBX 4291. Personnel-related costs (including stock-based compensation), increased by $1.4 million, primarily due to increased headcount and stock-based compensation expense. Facility-related and other, 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 $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.

Previous wording

General and administrative expenses were $2.9 million for the three months ended September 30, 2024, as compared to $1.9 million for the three months ended September 30, 2023. The increase of $1.0 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 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.

Previous wording

Interest and other income, net, which includes interest income and amortization of premiums and discounts on our investments in marketable securities, were $1.5 million for the three months ended September 30, 2024, as compared to $0.8 million for the three months ended September 30, 2023. The increase of $0.7 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 $2.6 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.

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 September 30, 2024 and December 31, 2023, we had $277.1 million and $80.7 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.

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 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.

Previous wording

the costs, timing, and outcome of regulatory review of any of our existing or future product candidates by the U.S. Food and Drug Administration ("FDA") and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more preclinical studies or clinical trials than those that we currently expect or for such authorities to change their requirements on studies that had previously been agreed to;

Current wording

the costs, timing, and outcome of regulatory review of any of our existing or future product candidates by the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more preclinical studies or clinical trials than those that we currently expect or for such authorities to change their requirements on studies that had previously been agreed to;

Previous wording

We had $277.1 million and $80.7 million in cash, cash equivalents and marketable securities as of September 30, 2024 and December 31, 2023, 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 $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.

Previous wording

Net cash used in operating activities for the nine months ended September 30, 2024 was $38.6 million. This was primarily due to our net loss of $46.3 million, partially offset by net cash provided by changes in our operating assets and liabilities of $5.2 million and non-cash charges of $2.5 million. The changes in our net operating assets and liabilities primarily consisted of a $6.7 million increase in accounts payable and accrued expenses primarily related to balances with CDMOs, partially offset by a $1.3 million increase in our prepaid expenses and other current assets related to prepaid balances with CROs. Non-cash charges primarily consisted of $3.7 million of stock-based compensation expense, partially offset by $1.5 million of net amortization and accretion of marketable securities.

Current 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.

Previous wording

Net cash used in operating activities for the nine months ended September 30, 2023 was $20.8 million. This was primarily due to our net loss of $23.7 million, partially offset by net cash provided by changes in our operating assets and liabilities of $2.1 million and non-cash charges of $0.8 million. The changes in our net operating assets and liabilities primarily consisted of a $1.9 million increase in accounts payable and accrued expenses and a $0.3 million decrease in our prepaid expenses and other current assets. Non-cash charges primarily consisted of $1.0 million of stock-based compensation expense, partially offset by $0.4 million of net amortization and accretion of marketable securities.

Current 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.

Previous wording

Net cash used in investing activities for the nine months ended September 30, 2024 was $93.3 million, which consisted of maturities of marketable securities of $152.0 million and purchases of property and equipment of $0.8 million, partially offset by maturities of marketable securities of $59.5 million.

Current 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.

Previous wording

Net cash used in investing activities for the nine months ended September 30, 2023 was $2.0 million, which consisted of purchases of marketable securities of $30.0 million and purchases of property and equipment of $0.1 million, partially offset by maturities of marketable securities of $28.0 million.

Current 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.

Previous wording

Net cash provided by financing activities for the nine months ended September 30, 2024 was $234.2 million, which primarily consisted of proceeds from our IPO, net of underwriting discounts and commissions, of $174.5 million in September 2024, gross proceeds from our issuance of Series C Convertible Preferred Stock of $63.5 million in August 2024 and proceeds from the exercise of stock options of $0.2 million, partially offset by payments related to IPO costs of $3.7 million and preferred stock offering costs of $0.3 million.

Current wording

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

Previous wording

Net cash provided by financing activities for the nine months ended September 30, 2023 was $69.2 million, which consisted of proceeds from our issuance of Series B Convertible Preferred Stock of $68.5 million in August 2023 and proceeds from the exercise of common stock options of $0.7 million.

Current 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.

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 September 30, 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. As of December 31, 2023, our future remaining operating lease payments were $0.4 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 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.

Previous wording

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

Current 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.

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 IPO Prospectus.

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 Annual Report.

Previous wording

During the nine months ended September 30, 2024, 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 IPO Prospectus, except that our common stock is now publicly traded and we therefore no longer require common stock valuations.

Current 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.