Quantitative and Qualitative Disclosures About Market Risk
−Removed: Not applicable.
+Added: We are exposed to market risks that may result from changes in interest rates and foreign currency exchange rates.
+Added: Interest Rate Risk
+Added: Investments in marketable securities
+Added: As of March 31, 2026 and December 31, 2025, we had cash, cash equivalents and marketable securities of $362.9 million and $360.0 million, respectively.
+Added: This consisted of interest-bearing money market accounts and investments in U.S.
+Added: government securities, commercial paper, and corporate debt securities, which create an exposure to interest rate risk.
+Added: Our future interest income may fall short of expectations due to changes in market conditions and in interest rates and such changes in interest rates may affect the fair value of the marketable securities held in our portfolio and cause unrealized gains or losses.
+Added: Such gains or losses would not be realized unless the investments are sold.
+Added: A hypothetical one percent increase in interest rates as of March 31, 2026 and December 31, 2025 would not have resulted in a material effect on the fair market value of our cash, cash equivalents and marketable securities.
+Added: Long-term debt
+Added: As of March 31, 2026 we had an outstanding term loan with a carrying value of $38.8 million bearing interest at a rate equal to the greater of (i) 7.95% or (ii) the prime rate plus 0.95%.
+Added: A hypothetical one percent increase in the prime rates as of March 31, 2026 would not have resulted in a material effect on the fair market value of our debt.
+Added: In addition, a hypothetical one percent increase in the prime rates as of March 31, 2026 would not result in a material impact to our income for the year ending December 31, 2026.
+Added: We did not have any outstanding debt as of December 31, 2025.
+Added: Foreign Currency Exchange Risk
+Added: The majority of our transactions occur in U.S.
+Added: However, we do have certain transactions that are denominated in currencies other than the U.S.
+Added: dollar, primarily the euro and British pound, and we therefore are subject to foreign exchange risk.
+Added: The fluctuation in the value of the U.S.
+Added: dollar against other currencies affects the reported amounts of expenses, assets and liabilities primarily associated with a limited number of preclinical, clinical and manufacturing activities.
+Added: We do not hedge our foreign currency exchange rate risk, however, we may do so in the future.
+Added: As of March 31, 2026 and December 31, 2025, we had no material accounts payable or receivable denominated in foreign currencies, and a hypothetical 10% change in foreign currency exchange rates applicable to our business would not have a material impact on our condensed financial statements.
Co ntro ls and Procedures
Evaluation of Disclosure Controls and Procedures
−Removed: As of September 30, 2025, our management, including our Chief Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act.
+Added: As of March 31, 2026, our management, including our Chief Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act.
Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in U.S.
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Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
−Removed: Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2025, the design and operation of our disclosure controls and procedures were effective at a reasonable assurance level.
+Added: Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of March 31, 2026, the design and operation of our disclosure controls and procedures were effective at a reasonable assurance level.
Changes in Internal Control over Financial Reporting
−Removed: There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d)and 15d-15(d) of the Exchange Act that occurred during the quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
+Added: There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended March 31, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II – OT HER INFORMATION
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Additional risks and uncertainties not presently known to us or that we currently believe are immaterial may also significantly impair our business, financial condition or results of operations.
+Added: These disclosures reflect the management’s beliefs and opinions as to factors that could materially and adversely affect the Company and its securities in the future.
+Added: References to past events are provided by way of example only and are not intended to be a complete listing of such events or a representation as to whether or not such factors or similar events have occurred in the past or their likelihood of occurring in the future.
If any of these risks or uncertainties occur, our business, financial condition or results of operations could suffer, the market price of our common stock could decline and you could lose all or part of your investment in our common stock.
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Furthermore, we do not expect to generate any product revenue from commercial sales for the foreseeable future, and we expect to continue to incur significant operating losses for the foreseeable future due to the cost of clinical trials, preclinical studies, research and development, and the regulatory approval process of our therapeutic candidates.
−Removed: For the nine months ended September 30, 2025 and 2024, we incurred a net loss of $96.6 million and net income of $81.8 million, respectively.
−Removed: As of September 30, 2025, we had an accumulated deficit of $455.0 million.
+Added: For the three months ended March 31, 2026 and 2025, we incurred a net loss of $24.2 million and $32.8 million, respectively.
+Added: As of March 31, 2026, we had an accumulated deficit of $513.8 million.
We expect to continue to incur significant research and development and other expenses related to our ongoing operations.
Since our inception, we have focused substantially all of our efforts and financial resources on research and development activities for our programs and on establishing arrangements and collaborations with third parties for the development of our therapeutic candidates.
−Removed: To date, we have not generated any product revenue from product sales and have financed our operations primarily through sales of our equity and convertible promissory notes, as well as one-time, nonrefundable, upfront licensing payments.
+Added: To date, we have not generated any product revenue from product sales and have financed our operations primarily through sales of our equity and convertible promissory notes, debt financing, as well as one-time, nonrefundable, upfront licensing payments.
Our prior losses, combined with expected future losses, have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital.
−Removed: We expect our research and development expenses to significantly increase in connection with clinical trials for our lead programs, MZE829 and MZE782, further development of our Maze Compass platform, or our Compass platform, planned preclinical studies, IND filings and clinical trials for future therapeutic candidates.
+Added: We expect our research and development expenses to significantly increase in connection with the ongoing clinical trials for our lead programs, MZE829 and MZE782, further development of our Maze Compass platform, or our Compass platform, planned preclinical studies, IND filings and clinical trials for future therapeutic candidates.
We will also incur substantial additional expenses as we seek to expand our intellectual property portfolio, including through potential in-licensing opportunities, and hire additional personnel as we scale up our operations.
−Removed: We expect to incur additional costs associated with operating as a public company.
+Added: We expect to continue to incur additional costs associated with operating as a public company.
As a result, we expect to continue to incur significant and increasing operating losses for the foreseeable future.
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In addition, even if we obtain marketing approval for any of our therapeutic candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution.
−Removed: We expect to incur additional costs associated with operating as a public company.
+Added: We expect to continue to incur additional costs associated with operating as a public company.
Accordingly, we will need to obtain substantial additional capital in connection with our continuing operations.
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If we are unable to raise capital when needed or on favorable terms, we could be forced to delay, reduce or eliminate our clinical and preclinical development, research and development programs, our commercialization plans or other operations.
−Removed: As of September 30, 2025, our cash, cash equivalents and marketable securities were $383.9 million.
−Removed: Based on our current operating plan, we believe our existing cash, cash equivalents and marketable securities as of September 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements for at least one year from the date of this Quarterly Report on Form 10-Q.
+Added: As of March 31, 2026, our cash, cash equivalents and marketable securities were $362.9 million.
+Added: Based on our current operating plan, we believe our existing cash, cash equivalents and marketable securities as of March 31, 2026 will enable us to fund our operating expenses and capital expenditure requirements for at least one year from the date of this Quarterly Report on Form 10-Q.
We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
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Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.
−Removed: Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or therapeutic candidates.
+Added: Raising additional capital may cause dilution to our stockholders, cause the price of our common stock to decline, restrict our operations or require us to relinquish rights to our technologies or therapeutic candidates.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements.
−Removed: In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans.
−Removed: To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder.
+Added: We may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans.
+Added: We have an effective Form S-3ASR automatic shelf registration statement, or the “Shelf Registration,” on file with the Securities and Exchange Commission, or SEC, which allows us to sell any combination of common stock, preferred stock, debt securities, warrants, subscription rights, and/or units consisting of one or more of the foregoing in one or more offerings.
+Added: We have also entered into an Open Market Sale Agreement with Jefferies LLC, serving as our sales agent, with respect to an at-the-market offering program pursuant to which we may elect to issue and sell shares of our common stock having an aggregate offering price of up to $200.0 million, or the 2026 Sale Agreement, in such quantities and on such minimum price terms as we set from time to time through our sales agent.
+Added: To date, no sales have occurred under the 2026 Sale Agreement.
+Added: In April 2026, we completed an underwritten registered offering pursuant to which we issued and sold an aggregate of 5,540,000 shares of our common stock at $23.50 per share and pre-funded warrants to purchase 850,000 shares of our common stock at $23.499 per pre-funded warrant, which represents the per share offering price for the shares of common stock less a $0.001 per share exercise price for each pre-funded warrant, resulting in estimated net proceeds of approximately $144.7 million, after deducting underwriting discounts and commissions and estimated offering expenses.
+Added: The issuance of additional shares of our common stock pursuant to the Shelf Registration or the 2026 Sale Agreement, or issuances of securities convertible into or exercisable for our common stock or other equity-linked securities, including preferred stock, warrants, debt securities or units, would dilute the ownership interest of our existing stockholders.
+Added: Further, any such sales, or the anticipation of such sales, could depress the market price of our common stock and impair our ability to raise capital through the sale of additional securities.
Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends.
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Our loan and security agreement provides our lender with a first priority lien against substantially all of our assets, except for intellectual property, and contains restrictive and financial covenants that may limit our operating flexibility.
−Removed: Our loan and security agreement, dated June 27, 2022, between us and Banc of California (f/k/a Pacific Western Bank), as amended as of the date hereof, or the Loan Agreement, is a line of credit secured by a lien covering substantially all of our personal property, excluding intellectual property.
−Removed: The Loan Agreement contains customary representations and warranties, events of default and affirmative and negative covenants, including covenants that limit or restrict our ability to, among other things, dispose of assets, make changes to our business, management, ownership or business locations, merge or consolidate, incur additional indebtedness, pay dividends or other distributions or repurchase equity, make investments and certain capital expenditures, and enter into certain transactions with affiliates, in each case subject to certain exceptions.
−Removed: Our ability to comply with these and other covenants is dependent on several factors, some of which are beyond our control.
−Removed: While we have not drawn on the Loan Agreement to date, the restrictions and covenants in the Loan Agreement, as well as those contained in any future debt financing agreements that we may enter into, may restrict our ability to finance our operations and engage in, expand or otherwise pursue our business activities and strategies.
−Removed: Our ability to comply with these covenants and restrictions may be affected by events beyond our control, and breaches of these covenants and restrictions could result in a default under the Loan Agreement or under any future financing agreements that we may enter into, which would give our lenders the right to terminate their commitments to provide loans and to declare all borrowings outstanding, together with accrued and unpaid interest and fees, to be immediately due and payable.
−Removed: Further, the interest rate for any future term loan drawn under the Loan Agreement will be based on the published prime rate, a floating rate, subject to a maximum rate equal to the greater of (i) 0.75% above the published prime rate as then in effect and (ii) 4.50%.
+Added: On February 4, 2026, we entered into a loan and security agreement, or the Hercules Loan Agreement, with certain lenders and Hercules Capital, Inc., in its capacity as administrative agent and collateral agent for itself and the lenders party thereto, which provides for a senior secured term loan facility, or the Hercules Term Loan Facility, in an aggregate principal amount of up to $200.0 million.
+Added: An initial term loan of $40.0 million was funded under the Hercules Loan Agreement and the Hercules Term Loan Facility includes up to six additional term loan tranches providing up to an aggregate $160.0 million in additional loan commitments through February 2031, so long as we satisfy certain conditions precedent.
+Added: The final tranche of $50.0 million is subject to approval by the lenders’ investment committee.
+Added: The facility has a maturity date of February 1, 2031, and may be prepaid at any time, subject to prepayment premiums.
+Added: This senior secured term facility will accrue interest at an annual rate determined by reference to the Prime Rate as reported in the Wall Street Journal, with interest rate floors that range from 7.95% to 9.25% depending on the tranche.
+Added: Accrued interest is payable on the first business day of each month until (a) February 2030 or (b) if certain performance and financing milestones are satisfied, the maturity date.
The Federal Reserve has raised, and may in the future further raise, interest rates to combat the effects of recent high inflation.
An increase in the prime rate resulting in interest rates above the set minimum rate would increase our debt service obligations, which could have a negative impact on our cash flow, financial position or operating results, or result in increased borrowing costs in the future.
+Added: All of our obligations under the Hercules Loan Agreement are secured by a first lien perfected security interest on substantially all of our existing assets and after-acquired assets, except for intellectual property, subject to customary exceptions.
+Added: The Hercules Loan Agreement contains certain representations and warranties, affirmative covenants, negative covenants, financial covenants, and conditions that are customarily required for similar financings.
+Added: The affirmative covenants, among other things, require us to undertake various reporting and notice requirements and an obligation to maintain in force certain rights, approvals and assets.
+Added: The negative covenants restrict or limit our ability to, among other things and subject to certain exceptions contained in the Hercules Loan Agreement, incur new indebtedness, create liens on assets, engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s business activities, and to make Investments (as defined in the Hercules Loan Agreement) or distributions, or redemptions, in each case subject to customary exceptions.
+Added: The negative covenants also restrict our ability to change our fiscal year, repay certain other indebtedness, engage in certain affiliate transactions, or enter into, amend or terminate any other agreement that has the impact of restricting our ability to make loan repayments under the Hercules Loan Agreement.
+Added: In addition, unless either (i) our market capitalization is greater than or equal to $450.0 million and an aggregate of no more than $85.0 million in principal amount is outstanding under the term loans or (ii) our market capitalization is greater than or
+Added: equal to $750.0 million, we must at all other times maintain unrestricted cash and cash equivalents of at least 50% of the outstanding loan amount, decreasing to 40% and 35% upon satisfaction of certain performance and financing milestones.
+Added: Our ability to comply with these covenants and restrictions may be affected by events beyond our control, and breaches of these covenants and restrictions could result in a default under the Hercules Loan Agreement or under any future financing agreements that we may enter into, which would give our lenders the right to terminate their commitments to provide loans and to declare all borrowings outstanding, together with accrued and unpaid interest and fees, to be immediately due and payable.
+Added: Conforming to such restrictive and financial covenants under the Hercules Loan Agreement may limit our operating flexibility and we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to third parties to develop and market therapeutic candidates that we would otherwise prefer to develop and market ourselves.
+Added: The Hercules Loan Agreement also contains certain customary Events of Default (as defined in the Hercules Loan Agreement).
+Added: The occurrence of an Event of Default could result in, among other things, the declaration that all outstanding principal and interest under the Hercules Term Loan Facility are immediately due and payable in whole or in part.
+Added: See Note 10, Loan and security agreement, in Part I, Item 1 of this Quarterly Report on Form 10-Q for further discussion of the Hercules Loan Agreement.
Risks related to discovery and development of our therapeutic candidates
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We do not have any products that are approved for sale in any jurisdiction.
−Removed: We initiated a Phase 2 trial of MZE829, our most advanced lead program, in November 2024, dosed our first patient in February 2025 and expect to report topline proof of concept data on initial patients by the end of the first quarter of 2026.
−Removed: We initiated a Phase 1 clinical trial of our second lead program, MZE782, in September 2024 and announced results from the Phase 1 clinical trial in September 2025.
+Added: We initiated a Phase 2 trial of MZE829, our most advanced lead program, in November 2024, dosed our first patient in February 2025 and reported positive topline clinical proof of concept data in March 2026.
+Added: We initiated a Phase 1 clinical trial of our second lead program, MZE782, in September 2024 and announced initial clinical data in phenylketonuria, or PKU, and chronic kidney disease, or CKD, in September 2025.
+Added: We plan to initiate two Phase 2 trials of MZE782 in PKU and CKD in 2026.
Our other programs are at an early research stage, with no therapeutic candidates identified.
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• obtaining appropriate support from patient advocacy organizations;
−Removed: • addressing any delays in our clinical trials, or in the manufacture or distribution of our therapeutic candidates, if approved, resulting from any major natural disasters, health pandemics or significant political events;
+Added: • addressing any delays in our clinical trials, or in the manufacture or distribution of our therapeutic candidates, if approved, resulting from any major natural disasters, health pandemics, economic conditions or significant political events;
• maintaining a continued acceptable safety profile of the products following approval.
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We have limited experience designing and implementing clinical trials.
−Removed: We initiated a Phase 2 trial of MZE829, our most advanced lead program, in November 2024, dosed our first patient in February 2025 and expect to report topline proof of concept data on initial patients by the end of the first quarter of 2026.
−Removed: We initiated a Phase 1 clinical trial of MZE782 in September 2024 and announced initial clinical data in phenylketonuria, or PKU, and chronic kidney disease, or CKD, in September 2025 and plan to initiate two Phase 2 trials of MZE782 in PKU and CKD in 2026.
+Added: We initiated a Phase 2 trial of MZE829, our most advanced lead program, in November 2024, dosed our first patient in February 2025 and reported positive topline clinical proof of concept data in March 2026.
+Added: We initiated a Phase 1 clinical trial of MZE782 in September 2024 and announced initial clinical data in PKU and CKD in September 2025.
+Added: We plan to initiate two Phase 2 trials of MZE782 in patients with PKU and in patients with CKD in 2026.
Failure to design any one of our clinical trials adequately, or incorrect assumptions about the design of the trial, could adversely affect the ability to initiate the trial, enroll patients, complete the trial, or use the clinical trial’s results to support an application for regulatory approval, as well as lead to increased or unexpected costs.
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Clinical trials of a new therapeutic candidate require the enrollment of a sufficient number of patients, which may include patients who are suffering from the disease the therapeutic candidate is intended to treat and who meet other eligibility criteria, which may require genetic testing of prospective patients.
−Removed: Rates of patient enrollment are affected by many factors, including the size of the patient population, the eligibility criteria for the clinical trial, the age and condition of the patients, the stage and severity of disease, the nature of the protocol, the proximity of patients to clinical sites, and the availability of effective treatments or competing academic and other clinical trials for the relevant disease.
+Added: Rates of patient enrollment are affected by many factors, including the size of the patient population, the eligibility criteria for the clinical trial, the age and condition of the patients, the stage and severity of disease, the nature of the protocol, the proximity of patients to clinical sites, and the availability of effective treatments or competing academic and other sponsored clinical trials for the relevant disease.
A therapeutic candidate can unexpectedly fail at any stage of preclinical and clinical development.
The historical failure rate for therapeutic candidates is high due to scientific feasibility, safety, efficacy, changing standards of medical care, and other variables.
−Removed: The novelty of our Compass platform may mean our failure rates are higher than historical norms.
+Added: Although our Compass platform was designed to increase the probability of developing new medicines, it may still result in high failure rates equivalent to historical norms.
We will have to conduct additional trials in our proposed indications to support any future regulatory submissions.
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The outcome of preclinical testing and early clinical trials may not be predictive of the success of later preclinical studies or clinical trials or of clinical trials of the same therapeutic candidates in other indications, and interim or preliminary results of a clinical trial do not necessarily predict final results.
−Removed: For example, even if successful, the results of our preclinical studies of our lead programs may not be predictive of the results of outcomes in subsequent clinical trials on human subjects.
+Added: For example, even if successful, the results of our preclinical studies or early clinical trials for our lead programs may not be predictive of the results of outcomes in subsequent clinical trials.
Later-stage clinical trials could differ in significant ways from early-stage clinical trials, including changes to inclusion and exclusion criteria, efficacy endpoints, dosing regimen and statistical design.
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We may experience difficulties in patient enrollment in our clinical trials for a variety of external reasons beyond our control, including supply chain disruptions, staffing shortages and other business and economic disruptions resulting from geopolitical actions, including war and terrorism, natural disasters, including earthquakes, typhoons, floods and fires, as well as other disruptions resulting from the impact of public health factors, including pandemics or other health crises, business disruptions of our strategic partners, third-party manufacturers, suppliers and other third parties upon which we rely.
−Removed: Our therapeutic candidates are developed using a precision medicine approach intended to identify specific genetic targets amenable to therapeutic intervention in kidney and metabolic diseases, including obesity.
−Removed: As a result, the potential population of patients eligible for enrollment in our clinical trials will be smaller than the population eligible for enrollment in trials targeting the entire population with the disease, and it may be difficult to identify and enroll adequate numbers of patients in our trials.
+Added: Our therapeutic candidates are developed using a precision medicine approach intended to identify specific targets amenable to therapeutic intervention in kidney and metabolic diseases.
+Added: As a result, the potential population of patients eligible for enrollment in our clinical trials may be smaller than the population eligible for enrollment in trials targeting the entire population with the disease, and it may be difficult to identify and enroll adequate numbers of patients in our trials.
For example, our therapeutic candidate MZE829 is targeted to treat kidney disease associated with genetic variations in the APOL1 gene, which are most prevalent in people of West African ancestry, including many who identify as Black, African American, Afro-Caribbean and Latina/Latino, which narrows the patient population eligible for enrollment in these trials.
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In general, the enrollment and retention of patients depends on many factors, including, but not limited to:
−Removed: • inability to enroll, or delay in enrollment of, patients due to infectious disease outbreaks and public health crises;
• the patient eligibility criteria defined in the protocol;
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• the ability to obtain and maintain patient consent;
+Added: • external factors such as geopolitical events, infectious disease outbreaks and public health crises;
• geopolitical events in countries where we have or seek to have clinical trial sites;
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• potential approval and commercial availability of a competitor’s product for the same indication.
−Removed: • the risk that patients enrolled in clinical trials will drop out of the trials before completion of treatment and adequate follow-up.
−Removed: In addition, our clinical trials will compete with other clinical trials for therapeutic candidates that are in the same therapeutic areas as our therapeutic candidates, and this competition will reduce the number and types of patients available to or retained by us because patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one or more of our competitors.
+Added: In addition, our clinical trials will compete with other clinical trials for therapeutic candidates that are in the same therapeutic areas as our therapeutic candidates, and this competition will reduce the number and types of patients available to or retained by us
+Added: because patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one or more of our competitors.
Other biopharmaceutical companies are currently conducting clinical trials, and may in the future conduct clinical trials, that compete for the same patient population as us.
Since the number of qualified clinical investigation sites is limited, and often associated with a small number of academic centers, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites.
−Removed: Unanticipated geopolitical events in countries where we may seek to have clinical trial sites could also negatively impact our ability to enroll or retain patients in our trials.
Our therapeutic candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, require expansion of the trial size, limit their commercial potential, or result in significant negative consequences.
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In addition, these side effects may not be appropriately recognized or managed by the treating medical staff, as safety and toxicity monitoring may be complicated and difficult to manage, which could result in patient death or other significant issues.
−Removed: Additionally, it can be difficult to determine if the serious adverse or unexpected side effects were caused by our therapeutic candidate or another factor, especially in subjects who may suffer from other medical conditions and take other medications.
+Added: Additionally, it can be difficult to determine if the serious adverse or unexpected side effects were caused by our therapeutic candidate or some other factor, especially in subjects who may suffer from other medical conditions and take other medications.
Any of these occurrences may materially harm our business, financial condition and prospects.
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• competitors may develop alternatives that render any therapeutic candidates we develop obsolete;
−Removed: • any therapeutic candidates we develop may nevertheless be covered by third parties’ patents or other exclusive rights;
+Added: • any therapeutic candidates we develop may be covered by third parties’ patents or other exclusive rights;
• a therapeutic candidate may be shown, in subsequent preclinical or clinical investigations, to have harmful side effects or characteristics that indicate it is unlikely to be effective, or otherwise would not meet applicable regulatory criteria;
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Interim, topline and preliminary data from preclinical studies and clinical trials that we or our partners announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
−Removed: From time to time, we or our partners may make public interim, topline or preliminary data from our or their preclinical studies and clinical trials that are based on a preliminary analysis of then-available data, of which, the results, related findings and conclusions are subject to change following a more comprehensive review of the data or accumulation of additional data.
+Added: From time to time, we or our partners may make public interim, topline or preliminary data from our or their preclinical studies and clinical trials that are based on a preliminary analysis of then-available data, of which, the results, related findings and conclusions
+Added: are subject to change following a more comprehensive review of the data or accumulation of additional data.
Interim, topline or preliminary data from clinical trials that we or our partners may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.
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While we have not identified any licenses that are required to conduct our genomics work to date, we may in the future identify a third-party technology we need to license to expand or continue to operate our Compass platform.
−Removed: For example, certain aspects of our Compass platform make use of CRISPR Cas9 technology at the early research stages, and while the patent coverage of such technology remains uncertain, certain institutions that have rights in CRISPR Cas9 patents have sought and may in the future seek to obtain license fees from biotechnology companies like ours.
+Added: For example, certain aspects of our Compass platform make use of CRISPR Cas9 technology at the early research stages, and while the patent coverage of such
+Added: technology remains uncertain, certain institutions that have rights in CRISPR Cas9 patents have sought and may in the future seek to obtain license fees from biotechnology companies like ours.
If we were unable to license or otherwise obtain access to such technology on reasonable terms or at all, and we were required to cease operation of our Compass platform, it would have a material adverse effect on our business, results of operations, financial condition and prospects.
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Our reliance on these CROs for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities.
−Removed: For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols in the applicable IND.
+Added: For example, we will remain responsible for ensuring that each of our clinical trials is conducted in
+Added: accordance with the general investigational plan and protocols in the applicable IND.
Moreover, the FDA requires compliance with standards, commonly referred to as good clinical practices for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected, and we will be responsible for ensuring our clinical trials are conducted in compliance with applicable laws and regulation, including good clinical practices.
If these CROs do not successfully carry out their contractual duties, meet expected deadlines or conduct the clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our therapeutic candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our therapeutic candidates, which may adversely affect our business, financial condition, results of operations and prospects.
−Removed: We rely on third parties to manufacture our clinical product supplies and therapeutic candidates and we may not be able to obtain adequate supplies at a reasonable cost or in a timely way.
+Added: We rely on third parties to manufacture our clinical product supplies and therapeutic candidates and we may not be able to obtain adequate supplies at a reasonable cost or in a timely manner.
The process of manufacturing pharmaceutical products is complex and highly regulated.
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If the FDA determines that our contract manufacturing organizations, or CMOs, are not in compliance with FDA laws and regulations, including those governing cGMPs, the FDA may not approve an NDA until the deficiencies are corrected or we replace the manufacturer in our application with a manufacturer that is in compliance.
−Removed: Moreover, our failure, or the failure of our third-party manufacturers and suppliers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, seizures or recalls of therapeutic candidates, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products.
+Added: Moreover, our failure, or the failure of our third-party manufacturers and suppliers, to comply with applicable regulations could result
+Added: in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, seizures or recalls of therapeutic candidates, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products.
In addition, approved products and the facilities at which they are manufactured are required to maintain ongoing compliance with extensive FDA requirements and the requirements of other similar agencies, including ensuring that quality control and manufacturing procedures conform to cGMP requirements.
28 unchanged sentences
Our current and anticipated future dependence upon others for the manufacture of our therapeutic candidates may adversely affect our future profit margins and our ability to commercialize any products that obtain marketing approval on a timely and competitive basis.
−Removed: We or some of our suppliers may experience disruption to their respective supply chain due to the effects of macroeconomic conditions, which could delay, prevent or impair our development or commercialization efforts.
−Removed: We and certain third parties with whom we work obtain certain clinical trial supplies and pharmaceutical products in countries affected by macroeconomic events and conditions, including inflation, interest rate fluctuations, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, increasing financial market volatility and uncertainty, the impact of war or military conflict, including regional conflicts around the world, and public health pandemics.
−Removed: In addition, supply chain disruptions and delays as a result of any new tariff policies or trade restrictions could negatively impact our cost of materials and production processes.
+Added: We or some of our suppliers may experience disruption to our or their respective supply chain due to the effects of macroeconomic conditions, which could delay, prevent or impair our development or commercialization efforts.
+Added: We or our third-party suppliers may be affected by macroeconomic events and conditions, including inflation, interest rate fluctuations, new or changing tariff policies or trade restrictions, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, increasing financial market volatility and uncertainty, the impact of war or military conflict, including regional conflicts around the world, and public health pandemics.
+Added: Supply chain disruptions could negatively impact our cost of materials and production processes.
For example, the United States has announced tariffs on many goods imported from specified nations, including China and those in the European Union.
−Removed: In addition, there are currently headlines and discussions concerning potential increased tariffs for pharmaceutical products, which may impact our supply chain and create uncertainty in the broader pharmaceutical industry.
−Removed: If we or certain third parties with whom we work are unable to obtain clinical trial supplies or pharmaceutical products in sufficient quantity and in a timely manner due to disruptions in the global supply chain caused by macroeconomic events and conditions, or if the costs of such materials increase due to tariffs or other factors, the development, testing and clinical trials of our product candidates may be delayed or infeasible, and regulatory approval or commercial launch of any resulting product may be delayed or not obtained, which could significantly harm our business.
+Added: In addition, recent media reports have suggested potential increased tariffs for pharmaceutical products, which may impact our supply chain and create uncertainty in the broader pharmaceutical industry.
+Added: If we or certain third parties with whom we work are unable to obtain clinical trial supplies or pharmaceutical products in sufficient quantity and in a timely manner due to disruptions in the global supply chain caused by macroeconomic events and conditions, or if the costs of such materials increase due to tariffs, trade restrictions or other factors, the development, testing and clinical trials of our product candidates may be delayed or infeasible, and regulatory approval or commercial launch of any resulting product may be delayed or not obtained, which could significantly harm our business.
Our reliance on third parties requires us to share certain of our trade secrets, which increases the possibility that a competitor or other third party will discover them or that our trade secrets will be misappropriated or disclosed.
23 unchanged sentences
In order to market and sell our products in any jurisdiction outside the United States, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.
−Removed: The approval procedure varies among countries and can involve additional testing.
−Removed: The time required to obtain approval may differ substantially from that required to obtain FDA approval.
+Added: The approval procedure varies from country to country and may involve additional testing.
+Added: The time required to obtain approval from foreign regulatory authorities may differ substantially from that required to obtain FDA approval.
The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval.
1 unchanged sentence
We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all.
−Removed: Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.
+Added: Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.
We may not be able to submit for marketing approvals and may not receive necessary approvals to commercialize our products in any market.
20 unchanged sentences
If we, or any of our partners or manufacturers, fail to comply with all regulatory requirements or experience unanticipated problems with our products, when and if any of them are approved, we could be subject to substantial penalties, including withdrawal of our product from the market.
−Removed: Any therapeutic candidate for which we, or any partners obtain marketing approval, as well as the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities.
+Added: Any therapeutic candidate for which we, or any of our partners obtain marketing approval, as well as the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities.
These requirements include, but are not limited to, restrictions governing promotion of an approved product, submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, and requirements regarding drug distribution and the distribution of samples to physicians and recordkeeping.
142 unchanged sentences
Failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting.
−Removed: The Securities and Exchange Commission, or the SEC, also may suspend or bar issuers from trading securities on U.S.
+Added: The SEC also may suspend or bar issuers from trading securities on U.S.
exchanges for violations of the FCPA accounting provisions.
130 unchanged sentences
Therefore, notwithstanding any potential promising results in earlier studies or clinical trials, we may face significant setbacks in current or future studies or clinical trials.
−Removed: If we are unable to use our platform discoveries platform to develop and market new drugs or therapies, our business may fail or we may never become profitable.
+Added: If we are unable to use our platform discoveries to develop and market new drugs or therapies, our business may fail or we may never become profitable.
We, or the third parties we rely on, may be unable to develop the diagnostic tests or clinical assays to successfully advance our therapeutic candidates through clinical trials or commercialization.
27 unchanged sentences
• unforeseen costs and expenses associated with creating an independent sales and marketing organization.
−Removed: If we are unable to establish our own sales and marketing capabilities, our revenue from product sales and our profitability, if any, are likely to be lower than if we ourselves were to market and sell any products that we develop.
+Added: If we are unable to establish our own sales and marketing capabilities and must rely on third parties to market and sell our products, our revenue from product sales and our profitability, if any, are likely to be lower than if we ourselves were to market and sell any products that we develop.
In addition, we may not be successful in entering into arrangements with third parties to market and sell our therapeutic candidates or may be unable to do so on terms that are acceptable to us.
78 unchanged sentences
Misconduct by these parties could include fraud or intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates:
−Removed: (i) FDA regulations or those of comparable foreign regulatory agencies, (ii) manufacturing or clinical standards, (iii) federal and state health and data privacy, security, fraud and abuse, government price reporting, transparency reporting requirements, and other healthcare laws and regulations in the United States and abroad, (iv) sexual harassment and other workplace misconduct, or (v) laws that require the true, complete and accurate reporting of financial information or data.
+Added: (i) FDA regulations or those of comparable foreign regulatory agencies, (ii) manufacturing or clinical standards, (iii) federal and state health and data privacy, security, fraud and abuse, government price reporting, transparency reporting requirements, and other healthcare laws and regulations in the United States and abroad, (iv) sexual
+Added: harassment and other workplace misconduct, or (v) laws that require the true, complete and accurate reporting of financial information or data.
Such misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation, or improper or unauthorized use of AI or machine learnings tools that result in the disclosure of confidential information or reliance on inaccurate information.
13 unchanged sentences
We also have outsourced elements of our information technology systems and operations to third parties, and as a result we rely on and manage a number of third-party vendors and other contractors and consultants who have access to and process our confidential information.
−Removed: Although we are still in the process of implementing our internal security controls, policies and other measures, we take steps designed to detect, mitigate, and remediate vulnerabilities in our information systems (such as our hardware and/or software, including that of third parties upon which we rely).
+Added: Although we are still in the process of implementing our internal security controls, policies and other measures, we have taken steps designed to detect, mitigate, and remediate vulnerabilities in our information systems (such as our hardware and/or software, including that of third parties upon which we rely).
We may not, however, detect and remediate all such vulnerabilities including on a timely basis.
2 unchanged sentences
We may also experience security incidents from inadvertent or intentional actions by our employees, third-party vendors, contractors, consultants, business partners and/or other third parties, including theft, fraud or unauthorized access to or use of our information technology systems, or attack or damage from hacking, cyberattacks or supply chain attacks by malicious third parties and sophisticated nation-state and nation-state-supported actors (including the deployment of harmful computer viruses and malware, ransomware, denial or degradation-of-service attacks, phishing attacks and other social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information), which may compromise our system infrastructure, or that of our third-party vendors and other contractors and consultants, impede our ability to conduct business, delay our financial reporting or lead to data leakage.
−Removed: While we have a security consultant provide annual assessments on our systems vulnerabilities, the risk of a security incident or disruption, particularly through cyberattacks or cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity, and sophistication of attempted attacks and intrusions from around the world have increased.
+Added: While we have a security consultant provide annual assessments on our systems vulnerabilities, the risk of a security incident or disruption, particularly through cyberattacks or cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, continues to increase as the number, intensity, and sophistication of attempted attacks and intrusions from around the world have increased.
We may not be able to anticipate all types of security threats, nor implement preventive measures effective against all such security threats.
1 unchanged sentence
Cyberattacks or security incidents could remain undetected for an extended period, which could potentially result in significant harm to our information technology systems, as well as unauthorized access to the information stored on and transmitted by our information technology systems.
−Removed: Even if identified, the full extent of a cyberattack or security incident may not be determined immediately and we may be unable to adequately investigate or remediate incidents or breaches due to attackers increasingly using tools and techniques that are designed to circumvent controls, to avoid detection, and to remove or obfuscate forensic evidence.
+Added: Even if identified, the full extent of a cyberattack or security incident may not be determined immediately and we may be unable to adequately investigate or remediate incidents or breaches due to attackers increasingly using tools and techniques that are designed to circumvent controls, to avoid
+Added: detection, and to remove or obfuscate forensic evidence.
Moreover, recovery of our information technology systems may be additionally hampered where we have outsourced the operation of information technology systems and information storage to third parties.
91 unchanged sentences
Our ability to stop unauthorized third parties from making, using, selling, offering to sell, importing or otherwise commercializing our technologies or therapeutic candidates is dependent upon the extent to which we have rights under valid and enforceable patents, trade secrets or other intellectual property or proprietary rights that cover these activities.
−Removed: If we or our current or future partners are unable to secure and maintain patent, trade secret or other intellectual property or proprietary protection for any technologies or therapeutic candidates we or they develop, or if the scope of the protection secured is not sufficiently broad, our competitors could develop and commercialize technologies or therapeutic candidates similar or identical to ours, and our ability to commercialize any technologies or therapeutic candidates we or our partners may develop or to otherwise compete effectively may be adversely affected.
+Added: If we or our current or future partners are unable to secure and maintain patent, trade secret or other intellectual property or proprietary protection for any technologies or therapeutic candidates we or they
+Added: develop, or if the scope of the protection secured is not sufficiently broad, our competitors could develop and commercialize technologies or therapeutic candidates similar or identical to ours, and our ability to commercialize any technologies or therapeutic candidates we or our partners may develop or to otherwise compete effectively may be adversely affected.
We have filed patent applications, both in the United States and internationally, protecting our inventions related to our MZE829 and MZE782 candidates as well as our out-licensed programs.
137 unchanged sentences
Additionally, our confidentiality agreements and other contractual protections may not be adequate to protect our intellectual property from unauthorized disclosure, third-party infringement or misappropriation (such as a cybersecurity breach).
−Removed: Any party with whom we have executed such an agreement may breach that agreement and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.
+Added: party with whom we have executed such an agreement may breach that agreement and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.
Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable.
126 unchanged sentences
• general economic and geopolitical conditions, including fluctuating interest and tariff rates, the impact of significant political, trade and regulatory developments, disruptions in the capital and credit markets, market volatility and inflation.
−Removed: As of September 30, 2025, there were 4,000,002 shares of our common stock outstanding that we subsequently registered under the Securities Act for resale on Form S-1.
−Removed: These shares may be freely sold in the public market.
−Removed: Furthermore, as of September 30, 2025, there were 5,231,090 shares of our common stock subject to outstanding pre-funded warrants, with an exercise price of $0.001 per share.
+Added: We may, from time to time, elect to sell securities in a public offering or private placement.
+Added: For example, in September 2025, we entered into a securities purchase agreement with certain investors, pursuant to which we issued and sold in a private placement an aggregate of 4,000,002 shares of our common stock and pre-funded warrants to purchase up to an aggregate of 5,231,090 shares of our common stock.
+Added: We subsequently registered the common stock (including the shares of common stock issuable upon exercise of the pre-funded warrants) under the Securities Act for resale on Form S-1, such that these shares may now be sold by the purchasers in the public market at any time.
+Added: Additionally, as of March 31, 2026, there were 4,331,090 shares of our common stock subject to outstanding pre-funded warrants, with an exercise price of $0.001 per share.
+Added: In April, 2026, we completed an underwritten registered offering pursuant to which we issued and sold an aggregate of 5,540,000 shares of our common stock and pre-funded warrants to purchase 850,000 shares of our common stock.
To the extent any of these warrants are exercised, the shares underlying these warrants may be immediately sold in the public market.
10 unchanged sentences
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us or our business.
−Removed: If any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectual property or our stock performance, or if our current or future clinical trials, preclinical studies and operating results fail to meet the expectations of analysts, our stock price would likely decline.
+Added: If any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectual property or our stock performance, or if our current or future clinical trials, preclinical studies and operating
+Added: results fail to meet the expectations of analysts, our stock price would likely decline.
If one or more of such analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause a decline in our stock price or trading volume.
6 unchanged sentences
We are subject to the periodic reporting requirements of the Exchange Act of 1934, as amended, or the Exchange Act.
−Removed: We designed our disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within
−Removed: the time periods specified in the rules and forms of the SEC.
+Added: We designed our disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
43 unchanged sentences
General risk factors
−Removed: We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.
−Removed: As a public company, and particularly after we are no longer an EGC or SRC, we incur significant legal, accounting and other expenses that we did not incur as a private company.
−Removed: The Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the Nasdaq Stock Market, LLC, or Nasdaq, and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.
−Removed: Our management and other personnel need to devote a substantial amount of time to these compliance initiatives.
−Removed: Moreover, we expect these rules and regulations to substantially increase our legal and financial compliance costs and to make some activities more time consuming and costly.
−Removed: For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain sufficient coverage.
−Removed: We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements.
−Removed: The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.
+Added: We incur increased costs as a result of operating as a public company, and our management must devote substantial time to compliance matters and corporate governance practices.
+Added: As a public company, and particularly after we are no longer an EGC, we incur significant legal, accounting and other expenses that we did not incur as a private company.
+Added: The Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the Nasdaq Stock Market, LLC, or Nasdaq, and other applicable securities rules and regulations impose various requirements on public companies, like us, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.
+Added: Our management and other personnel devote a substantial amount of time to these compliance matters.
+Added: Moreover, these rules and regulations have substantially increased our legal and financial compliance costs and have made some activities more time consuming and costly.
+Added: For example, as a public company, it is more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain sufficient coverage.
+Added: We cannot predict or estimate the amount or timing of additional costs we may incur in the future to respond to these requirements.
+Added: These requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.
The increased costs may require us to reduce costs in other areas of our business or increase the prices of our products once commercialized.
1 unchanged sentence
This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
−Removed: We are an “EGC” and a “SRC” and we cannot be certain if the reduced reporting requirements applicable to EGCs or SRCs will make our common stock less attractive to investors.
+Added: We are an “EGC” and we cannot be certain if the reduced reporting requirements applicable to EGCs will make our common stock less attractive to investors.
We are an “EGC” as defined in the JOBS Act.
7 unchanged sentences
Until the date that we are no longer an “EGC” or affirmatively and irrevocably opt out of the exemption provided by Section 7(a)(2)(B) of the Securities Act, upon issuance of a new or revised accounting standard that applies to our financial statements and that has a different effective date for public and private companies, we will disclose the date on which adoption is required for non-EGCs and the date on which we will adopt the recently issued accounting standard.
−Removed: We are also an “SRC.” We will continue to be an SRC so long as either (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million.
−Removed: If we are an SRC at the time we cease to be an EGC, we may continue to rely on the same exemptions from certain disclosure requirements, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation and the option to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K.
+Added: On December 31, 2025, we determined that we will no longer be a smaller reporting company, beginning with our first quarterly report for the quarter ending March 31, 2026.
+Added: However, because we remain an EGC, we may continue to rely on the same exemptions from certain disclosure requirements, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation and the option to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K.
We cannot predict if investors will find our common stock less attractive if we choose to rely on these exemptions.
5 unchanged sentences
We may be the target of this type of litigation in the future.
−Removed: We may also become subject to intellectual property, commercial or other litigation based on our statements, claims, actions, or inactions, among other things.
+Added: become subject to intellectual property, commercial or other litigation based on our statements, claims, actions, or inactions, among other things.
Litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business.
17 unchanged sentences
If we fail to maintain proper and effective internal controls over financial reporting, our ability to produce accurate and timely financial statements could be impaired.
−Removed: Pursuant to Section 404 of the Sarbanes-Oxley Act, our management will be required to report upon the effectiveness of our internal control over financial reporting beginning with the annual report for our fiscal year ending December 31, 2025.
−Removed: When we lose our status as an “EGC” or “SRC” and become an “accelerated filer” or a “large accelerated filer,” our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting.
−Removed: The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing, and possible remediation.
−Removed: To achieve compliance with Section 404 within the prescribed period, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging.
−Removed: In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.
−Removed: This process will be time-consuming, costly and complicated.
+Added: Pursuant to Section 404 of the Sarbanes-Oxley Act, our management is required to report upon the effectiveness of our internal controls over financial reporting beginning with this Annual Report on Form 10-K.
+Added: When we lose our status as an “EGC” and become an “accelerated filer” or a “large accelerated filer,” our independent registered public accounting firm will be required to attest to the effectiveness of our internal controls over financial reporting.
+Added: The rules governing the standards that must be met for management to assess our internal controls over financial reporting are complex and require significant documentation, testing, and possible remediation.
+Added: To comply with Section 404, we must document and evaluate our internal controls over financial reporting, which is both costly and challenging.
+Added: In this regard, we have dedicated significant internal resources, have engaged outside consultants as needed, and have adopted a detailed work plan to (i) assess and document the adequacy of internal control over financial reporting, (ii) take steps to improve control processes as appropriate, (iii) validate through testing that controls are functioning as documented, and (iv) implement a continuous reporting and improvement process for internal control over financial reporting.
+Added: This process is time-consuming, costly and complicated.
+Added: We believe that any internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
There may be material weaknesses or significant deficiencies in our internal control over financial reporting in the future.
15 unchanged sentences
Unregistered Sale of Securities.
+Added: On September 10, 2025, we entered into a securities purchase agreement with certain selling stockholders, pursuant to which we issued and sold an aggregate of (i) 4,000,002 shares of common stock at a purchase price of $16.25 per share and (ii) in lieu of shares of common stock for certain selling stockholders, warrants to purchase up to an aggregate of 5,231,090 shares of common stock at a purchase price of $16.249 per warrant, resulting in gross proceeds to us of $150.0 million.
+Added: For the year ended December 31, 2025, warrants to purchase 900,000 shares of our common stock were exercised.
+Added: No warrants were exercised for the three months ended March 31, 2026 and as of March 31, 2026, warrants to purchase 4,331,090 shares of our common stock remained outstanding.
+Added: This transaction was exempt from registration requirements of the Securities Act in reliance upon Section 4(a)(2) of the Securities Act or Regulation D promulgated under the Securities Act.
Use of Initial Public Offering Proceeds.
1 unchanged sentence
Securities and Exchange Commission, or the SEC.
−Removed: Upon the closing of the initial public offering on February 3, 2025, we issued 8,750,000 shares of common stock at a public offering price of $16.00 per share, resulting in net proceeds of approximately $127.8 million, after deducting underwriting discounts, commissions and other offering expenses paid in 2025.
+Added: Upon the closing of the initial public offering on February 3, 2025, we issued 8,750,000 shares of common stock at a public offering price of $16.00 per share, resulting in net proceeds of approximately $127.8 million, after deducting underwriting discounts, commissions and other payable offering expenses of approximately $12.2 million.
+Added: Morgan Securities LLC, TD Securities (USA) LLC, Leerink Partners LLC and Guggenheim Securities, LLC acted as joint book-running managers for the offering.
+Added: None of the expenses associated with our initial public offering were paid, directly or indirectly, to any of our directors or officers, any persons owning 10% or more of any class of equity securities, or to any of our affiliates.
There has been no material change in the planned use of proceeds from the initial public offering as described in the prospectus filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act on January 31, 2025.
4 unchanged sentences
Ot her Information
−Removed: Director Departure
−Removed: On November 6, 2025, Sekar Kathiresan, a member of our board of directors, resigned from our board of directors and the committees thereof.
−Removed: Kathiresan’s departure was not a result of any disagreement with us over any of our operations, policies or practices.
Rule 10b5-1 Trading Plans
−Removed: During the three months ended September 30, 2025, the following directors and/or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” in each case as defined in Item 408 of Regulation S-K:
+Added: During the three months ended March 31, 2026, the following directors and/or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” in each case as defined in Item 408 of Regulation S-K:
Character of Trading Arrangement
4 unchanged sentences
Arrangement (1)
−Removed: Atul Dandekar , Chief Strategy & Business Officer
−Removed: September 29, 2025
−Removed: 12/29/2025- 12/4/2026
−Removed: Harold Bernstein, M.D., Ph.D , President, Research and Development and Chief Medical Officer
−Removed: September 29, 2025
−Removed: 12/29/2025- 12/29/2026
−Removed: Amy Bachrodt , SVP, Finance
−Removed: September 29, 2025
+Added: Jason Coloma , Chief Executive Officer and Director
+Added: February 6, 2026
5/15/2026- 5/15/2027
2 unchanged sentences
1 The trading arrangement may expire on an earlier date if and when all transactions under the arrangement are completed.
−Removed: 2 This amount represents the maximum total shares that could be sold under the plan.
EXHIBIT INDEX
1 unchanged sentence
Description of document
−Removed: Form of Pre-Funded Warrant.
−Removed: September 11, 2025
−Removed: Form of Securities Purchase Agreement.
−Removed: September 11, 2025
−Removed: Form of Registration Rights Agreement.
−Removed: September 11, 2025
−Removed: Offer Letter by and between Maze Therapeutics, Inc.
−Removed: and Misbah Tahir.
−Removed: Filed herewith
+Added: Loan and Security Agreement, dated February 4, 2026, by and between Maze Therapeutics, Inc.
+Added: and Hercules Capital, Inc.
Certification of Chief Executive Officer Pursuant to Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
14 unchanged sentences
Filed herewith
−Removed: * Schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K.
−Removed: A copy of any omitted schedule and/or exhibit will be furnished to the SEC upon request.
* This certification is deemed not filed for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
1 unchanged sentence
MAZE THERAPEUTICS, INC.
−Removed: November 6, 2025
/s/ Jason Coloma
2 unchanged sentences
MAZE THERAPEUTICS, INC.
−Removed: November 6, 2025
/s/ Misbah Tahir
2 unchanged sentences
MAZE THERAPEUTICS, INC.
−Removed: November 6, 2025
/s/ Amy Bachrodt
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.