MBX Biosciences, Inc.

Current report

During the three months ended March 31, 2025, we repurchased 173 shares of our common stock from a former consultant as detailed in the following table:

Current report

(1) We repurchased shares of our common stock that were previously issued upon the early exercise of employee stock options in connection with the exercise of our repurchase right upon cessation of service of certain of our employees and directors.

Current report

(2) We did not have a repurchase program in place during the three months ended March 31, 2025.

Current report

None.

Current report

(a) On May 9, 2025, we entered into a first amendment (the "First Amendment") to our lease, dated April 28, 2022 (the "Carmel Lease"), with Zeller-Carmel Property, LLC, related to our principal executive office.

Current report

Pursuant to the terms of the First Amendment, the leased premises are expanded from 6,493 square feet of office space to 8,260 square feet of office space, and the expiration date of the lease is extended from December 31, 2025 to December 31, 2028, with an option to extend for 36 additional months at our discretion. Future minimum rent payments under the First Amendment total $0.7 million.

Current report

The foregoing summary of the First Amendment does not purport to be a complete description of the document and is qualified in its entirety by the First Amendment, a copy of which is filed as Exhibit 10.1 to this Quarterly Report on Form 10-Q and incorporated herein by reference.

Previous report

Risks related to financial position and need for capital

Previous report

We have incurred significant losses since inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.

Previous report

Since inception, we have incurred significant operating losses. Our net loss was $46.3 million and $32.6 million for the nine months ended September 30, 2024 and the year ended December 31, 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $121.9 million. As of December 31, 2023, we had an accumulated deficit of $75.6 million. We have financed our operations primarily through our issuance and sale of our common stock, convertible preferred stock and convertible promissory notes. Substantially all of our losses have resulted from expenses incurred in connection with our research and development and from general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating 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 our current product candidates and potential future product candidates. The net losses we incur may fluctuate significantly from quarter to quarter. We anticipate that our expenses will increase substantially for the foreseeable future if and as we:

Previous report

advance our current research activities and further develop our platform;

Previous report

continue preclinical development and progress clinical trials for our product candidates and any future product candidates we may identify;

Previous report

seek regulatory approval for any product candidates for which we successfully complete clinical trials;

Previous report

establish our manufacturing capacity capabilities to supply our clinical trials in our pipeline and eventually for commercialization;

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commercialize our product candidates, if approved, which will require significant marketing, sales, and distribution infrastructure expenses;

Previous report

hire additional research and development, clinical, commercial, and general and administration personnel;

Previous report

develop, maintain, expand, protect, and enforce our intellectual property portfolio;

Previous report

acquire or in-license product candidates, intellectual property and technologies;

Previous report

confirm, maintain or obtain freedom to operate for any of our owned or licensed technologies and product candidates;

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establish and maintain collaborations;

Previous report

add operational, financial and management information systems and personnel; or

Previous report

incur additional legal, audit, accounting, compliance, insurance, investor relations and other expenses to continue to operate as a public company that we did not incur as a private company.

Previous report

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, which may include collaborations with other companies or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, reduce or eliminate the development and commercialization of our platform, product candidates or delay our pursuit of potential in-licenses or acquisitions.

Previous report

We have not yet demonstrated an ability to successfully complete any pivotal clinical trials, advance any product candidate beyond Phase 2, obtain regulatory approvals, manufacture our product candidates at commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. To become and remain profitable, we must develop and, either directly or through collaborators, eventually commercialize a therapy or therapies with market potential. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of product candidates, obtaining regulatory approval for these product candidates, manufacturing, marketing and selling those therapies for which we may obtain regulatory approval and satisfying any post-marketing requirements. We may never succeed in these activities and, even if we do, may never generate revenues that are significant or large enough to achieve profitability.

Previous report

Because of the numerous risks and uncertainties associated with developing our technology, platform and our product candidates, we are unable to predict the extent of any future losses or when we will become profitable, if at all. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

Previous report

We have never generated revenue from product sales and may never become profitable.

Previous report

Our ability to generate revenue from product sales and achieve profitability depends on our ability, alone or with collaborative partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, our product candidates. We may not generate revenues from product sales for many years, if ever. Our ability to generate future revenues from product sales depends heavily on our or our collaborators’ ability to successfully:

Previous report

complete research and development of our product candidates;

Previous report

identify new product candidates;

Previous report

seek and obtain regulatory approvals for any product candidates for which we successfully complete clinical trials;

Previous report

launch and commercialize any product candidates for which we may obtain regulatory approval by establishing a sales force, marketing and distribution infrastructure, or alternatively, collaborating with a commercialization partner;

Previous report

qualify for adequate coverage and reimbursement by government and third-party payors for any product candidates for which we may obtain regulatory approval;

Previous report

establish and maintain supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and the market demand for any product candidates for which we obtain regulatory approval;

Previous report

develop, maintain and enhance a sustainable, scalable, reproducible and transferable manufacturing process for the product candidates we may develop;

Previous report

address competing technological and market developments;

Previous report

negotiate favorable terms in any collaboration, licensing or other arrangements into which we may enter and performing our obligations in such collaborations;

Previous report

receive market acceptance by physicians, patients, healthcare payors, and others in the medical community;

Previous report

maintain, protect, enforce, defend and expand our portfolio of intellectual property and other proprietary rights, including patents, trade secrets and know-how;

Previous report

defend against third-party intellectual property claims of infringement, misappropriation or other violation; and

Previous report

attract, hire and retain qualified personnel.

Previous report

Our expenses could increase beyond expectations if we are required by the U.S. Food and Drug Administration ("FDA") or other regulatory authorities to perform preclinical studies or clinical trials in addition to those that we currently anticipate. Even if one or more of our product candidates are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Additionally, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives. Even if we are able to generate revenues from the sale of any approved product candidates, we may not become profitable and may need to obtain additional funding to continue operations.

Previous report

We will need substantial additional funding. If we are unable to raise additional capital when needed on acceptable terms, or at all, we may be forced to delay, reduce, or terminate certain of our research and product development programs, future commercialization efforts or other operations.

Previous report

Developing product candidates, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue, initiate and conduct clinical trials of, and seek regulatory approval for, our product candidates. In addition, if we obtain regulatory approval for our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution to the extent that such sales, marketing, manufacturing, and distribution are not the responsibility of a collaborator. Other unanticipated costs may also arise. Furthermore, we expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce, or eliminate our research and product development programs, future commercialization efforts or other operations.

Previous report

As of September 30, 2024, our cash, cash equivalents and marketable securities were $277.1 million. We expect that our existing cash, cash equivalents, and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into mid-2027. However, our operating plan may change as a result of factors currently unknown to us, and we may need to seek funding sooner than planned. Our future capital requirements will depend on many factors, including:

Previous report

the number, scope and duration of clinical trials required for regulatory approval of our product candidates;

Previous report

the costs, timing, and outcome of regulatory review of any of our product candidates;

Previous report

the costs of manufacturing clinical and commercial supplies of our product candidates;