← Back to EWTX filing summaryOriginal filing text · Part I
Item 2 — Management's Discussion and Analysis
Edgewise Therapeutics, Inc. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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The following discussion of the financial condition and results of operations of Edgewise Therapeutics, Inc. should be read in conjunction with the financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q (Quarterly Report), and the audited financial statements and the related notes thereto included in our Annual Report on Form 10-K (Annual Report), filed with the Securities and Exchange Commission, on February 26, 2026. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.
As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in or implied by these forward-looking statements. You should carefully read the “Risk Factors” to gain an understanding of the factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”
Overview
Since our inception in 2017, we have applied our deep expertise in muscle biology and small molecule drug discovery to build a proprietary precision medicine platform. This foundation has generated multiple clinical and preclinical programs across skeletal and cardiac muscle, including sevasemten for muscular dystrophies and our cardiovascular portfolio of novel, oral cardiac sarcomere modulators. In May 2026, we entered into an Asset Purchase Agreement under which Servier Pharmaceuticals LLC and Les Laboratoires Servier (Servier) acquired sevasemten and our muscular dystrophy program for $1,550 million in upfront cash consideration and up to $1,100 million in additional regulatory and commercial milestone payments, for aggregate potential consideration of up to $2,650 million (Sevasemten Sale). On July 10, 2026, the Sevasemten Sale was completed.
Following this transaction, Edgewise is positioned as a cardiovascular-focused late-stage clinical biopharmaceutical company advancing therapies for people living with serious cardiovascular diseases. Our lead cardiovascular program, EDG-7500, is a novel, oral, selective cardiac sarcomere modulator currently being studied in a multipart Phase 2 trial in patients with obstructive and nonobstructive hypertrophic cardiomyopathy, with a Phase 3 program targeted to initiate in the fourth quarter of 2026. EDG-15400, our second cardiovascular product candidate, is currently in a Phase 1 trial in healthy adults, with a future disease target of heart failure with preserved ejection fraction, and we expect to initiate a Phase 2 trial in the second half of 2026. We are also continuing to advance preclinical discovery efforts, including additional cardiovascular and cardiometabolic targets, as we pursue our mission of changing the lives of patients and families affected by serious cardiovascular diseases.
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We have incurred significant losses since the commencement of our operations. Our net losses were $57.3 million and $106.3 million for the three and six months ended June 30, 2026, respectively, and $36.1 million and $76.9 million for the three and six months ended June 30, 2025, respectively, and we expect to continue to incur significant losses for the foreseeable future as we advance our product candidates through preclinical development and clinical trials and seek regulatory approval of our product candidates. Our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.
As of June 30, 2026, we had an accumulated deficit of $652.7 million. To date, we have financed our operations primarily through private placements of convertible preferred stock and public offerings of our common stock. From inception to our initial public offering, private placements provided gross proceeds of $160.7 million, and, as of June 30, 2026, we generated net proceeds from our initial public offering, follow-on public offering, issuance of our common stock under an “at the market offering” program (the ATM Program), and the January 2024 and April 2025 underwritten registered direct offerings of $793.7 million. We believe that our existing cash and cash equivalents and marketable securities of $460.7 million, together with the $1,550 million in upfront cash proceeds from the Sevasemten Sale received on July 10, 2026, will enable us to fund our planned operating expenses and capital expenditure requirements through at least the next 12 months.
Macroeconomic and Geopolitical Developments
We are monitoring macroeconomic and geopolitical developments, such as inflation, instability in the banking and financial services sector, tightening of the credit markets, changes in the U.S. government administration and policy positions, international conflicts, public health pandemics, cybersecurity, sanctions, and changes in tariffs, and evaluating potential impacts on our operations, clinical development timelines, supply chain continuity and capital markets access. The extent, severity, and duration of the impacts of these events and conditions on our business, operations and research and development timelines and plans cannot be predicted and will depend on numerous factors. For more information regarding the risks related to macroeconomic and geopolitical developments, see the section titled “Risk Factors” found elsewhere in this Quarterly Report.
Components of Our Results of Operations
Operating expenses
Operating expenses primarily consist of research and development activities and general and administrative functions that support our clinical programs and corporate infrastructure.
Research and development expenses
Research and development expenses consist primarily of costs incurred in connection with the discovery and development of our product candidates. We record research and development expenses when these are incurred. Such expenses include:
● employee and external consultant-related expenses including salaries, bonuses, benefits and stock-based compensation expense for employees engaged in research and development functions;
● external expenses incurred in connection with the clinical development of our product candidates including under agreements with third parties, such as consultants and contract research organizations (CROs);
● the cost of external manufacturing drug products for use in our preclinical studies and ongoing and planned clinical trials including under agreements with third parties such as consultants and CDMOs;
● expenses incurred in connection with the preclinical development of our product candidates including external, or outsourced professional scientific development services, consulting research fees and payments made under sponsored research arrangements with third parties;
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● laboratory supplies;
● facilities, depreciation and other expenses, which include direct or allocated expenses for rent and maintenance of facilities; and
● expenses related to compliance with regulatory requirements.
The majority of these expenses have been incurred to advance our lead product candidate EDG-7500, as well as sevasemten, our previous product candidate sold to Servier in July 2026. We expect that significant additional spending will be required to progress EDG-7500, EDG-15400, and other potential discoveries through later-stage clinical development phases and potentially registrational activities. These expenses will primarily consist of expenses for the administration of clinical trials as well as manufacturing costs for clinical material supply.
We track our direct research and development expenses on a program-by-program basis once a lead compound has been selected and clinical trials have been initiated. These direct costs consist primarily of external costs such as fees paid to outside consultants, CROs, CDMOs, clinical trial sites and central laboratories in connection with our discovery and preclinical activities, process development, manufacturing and clinical development activities. These expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. Our direct research and development expenses by program also include costs of laboratory supplies that can be directly attributed to a specific program as well as any fees incurred under license agreements. We do not allocate employee-related costs, including stock-based compensation, or facility expenses, including rent, depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources primarily to conduct our research and discovery activities and to manage our preclinical development, manufacturing and clinical development activities.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. In June 2026, we announced positive topline data for our multipart Phase 2 trial with EDG-7500 for people with HCM (CIRRUS-HCM) and are planning to initiate a Phase 3 trial for EDG-7500 in the fourth quarter of 2026 and we have completed dosing in the Phase 1 trial with EDG-15400 of healthy adults with the future disease target of HFpEF and are planning to initiate a Phase 2 trial for EDG-15400 in the second half of 2026. As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance EDG-7500, EDG-15400, and candidates from our EDG-003 cardiometabolic discovery program through clinical trials and additional product candidates; continue to develop our proprietary drug discovery platform; continue to discover and develop additional product candidates; and hire additional personnel.
The successful development of our product candidates is highly uncertain, and we do not believe it is possible at this time to accurately project the nature, timing and extent of expenses necessary to complete the development of our product candidates. We are also unable to predict when, if ever, we will generate revenue from our product candidates to offset these expenses. Our expenditures on current and future preclinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion. The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, including:
● the timing and progress of preclinical and clinical development activities;
● the number and scope of preclinical and clinical programs we decide to pursue;
● our ability to maintain our current research and development programs and to establish new ones;
● establishing an appropriate safety profile with IND-enabling studies;
● successful patient enrollment in, and the initiation and completion of, clinical trials;
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● the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;
● the receipt of regulatory approvals from applicable regulatory authorities;
● the timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
● our ability to establish new licensing or collaboration arrangements;
● the performance of our future collaborators, if any;
● establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
● development and timely delivery of sufficient supplies of our drug product that can be used in our planned clinical trials and for commercial launch upon approval;
● obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
● launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others; and
● maintaining a continued acceptable safety profile of the product candidates following approval..
Any changes in the outcome of any of these factors could significantly impact the costs and timing associated with the development of our product candidates. We may also adjust program prioritization or resource allocation based on emerging clinical data, regulatory feedback or capital availability.
General and administrative expenses
General and administrative expenses consist primarily of salaries, related benefits and stock-based compensation expense for personnel in executive, finance, accounting, legal and administrative functions. General and administrative expenses also include facilities and other expenses, which include direct or allocated expenses for rent and maintenance of facilities and insurance, not otherwise included in research and development expenses, as well as professional fees for legal, patent, consulting, investor and public relations, accounting and audit services. We continue to expand our administrative infrastructure to support the growth of our clinical programs and public company operations.
We anticipate that our general and administrative expenses will increase in the future as we scale our organization to support clinical advancement, regulatory readiness, and future commercial planning activities.
Interest income
Interest income primarily consists of interest income generated from our cash, cash equivalents and marketable securities.
Interest income may fluctuate in future periods based on cash deployment and prevailing market conditions.
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Results of Operations
Comparison of the three months ended June 30, 2026 and 2025
The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025:
Three months ended June 30,
2026 2025 Change
(in thousands)
Operating expenses:
Research and development $ 47,548 $ 33,558 $ 13,990
General and administrative 14,395 9,052 5,343
Total operating expenses 61,943 42,610 19,333
Loss from operations
Interest income 4,616 6,495 (1,879)
Net loss $ 57,327 $ 36,115 $ 21,212
Research and development expenses
The following table summarizes our research and development expenses:
Three months ended June 30,
2026 2025 Change
(in thousands)
External research and development expenses:
Sevasemten clinical program $ 13,211 $ 13,018 $ 193
EDG-7500 clinical program 8,058 3,099 4,959
EDG-15400 clinical program 3,388 — 3,388
Discovery and preclinical 2,334 2,612 (278)
Internal costs, including personnel related 20,557 14,829 5,728
Total research and development expenses $ 47,548 $ 33,558 $ 13,990
Research and development expenses were $47.5 million and $33.6 million for the three months ended June 30, 2026 and 2025, respectively. The increase was primarily due to higher EDG-7500, EDG-15400 and internal personnel-related costs, partially offset by lower discovery and preclinical expenses, and was attributed to the following:
● an increase in EDG-7500 clinical program expenses of $5.0 million primarily related to an increase of $0.4 million from completion of patient activity for Part D of our multipart Phase 2 CIRRUS-HCM trial, for which Part B and Part C were fully enrolled and Part D was enrolling in the comparable period in 2025, an increase of $2.0 million from pharmacokinetic studies, and a $2.6 million increase in other development costs primarily driven by nonclinical costs and manufacturing costs to support future trials;
● an increase in EDG-15400 clinical program expenses of $3.4 million which are now shown separately in the above table due to advancing into a Phase 1 trial in the third quarter of 2025. These expenses include clinical trial and nonclinical costs, as well as manufacturing costs to support current and future trials; and
● an increase in internal costs of $5.7 million, primarily related to personnel-related costs, including stock-based compensation, resulting from increased employee headcount to support the growth of our research and development programs; and
● an increase of $0.2 million in sevasemten clinical program expenses, which was primarily related to a $1.2 million increase in clinical program expenses in the MESA trial related to increased clinical activity due to patient rollover from the GRAND CANYON trial and $0.8 million increase in the GRAND CANYON trial, partially offset by $1.8 million in decreased activity across all other sevasemten trials;
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partially offset by:
● a decrease in discovery and preclinical expenses of $0.3 million, which was primarily driven by a decrease in EDG-15400 related costs, now shown separately, which were a significant portion of discovery, preclinical, and nonclinical expenses in the comparable period in 2025.
General and administrative expenses
General and administrative expenses increased to $14.4 million for the three months ended June 30, 2026 compared to $9.1 million for the three months ended June 30, 2025. The increase of $5.3 million was primarily attributable to $1.7 million in increased personnel-related costs, including stock-based compensation, associated with organizational growth, $1.4 million in increased costs associated with commercial readiness activities for sevasemten, as well as $2.3 million in increased professional and consulting costs, transaction costs related to the Sevasemten Sale, and other administrative costs supporting public company operations and clinical development activities.
Interest income
Interest income was $4.6 million for the three months ended June 30, 2026 compared to $6.5 million for the three months ended June 30, 2025. Interest income reflects returns generated from the investment of our cash, cash equivalents and marketable securities in accordance with our investment policies and may fluctuate in future periods based on prevailing market conditions and the timing of cash deployment.
Comparison of the six months ended June 30, 2026 and 2025
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:
Six months ended June 30,
2026 2025 Change
(in thousands)
Operating expenses:
Research and development $ 90,199 $ 70,315 $ 19,884
General and administrative 25,859 18,254 7,605
Total operating expenses 116,058 88,569 27,489
Interest income 9,718 11,656 (1,938)
Net loss $ 106,340 $ 76,913 $ 29,427
Research and development expenses
The following table summarizes our research and development expenses:
Six months ended June 30,
2026 2025 Change
(in thousands)
External research and development expenses:
Sevasemten clinical program $ 26,309 $ 27,058 $ (749)
EDG-7500 clinical program 13,880 7,290 6,590
EDG-15400 clinical program 6,509 — 6,509
Discovery and preclinical 4,409 5,455 (1,046)
Internal costs, including personnel related 39,092 30,512 8,580
Total research and development expenses $ 90,199 $ 70,315 $ 19,884
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Research and development expenses were $90.2 million and $70.3 million for the six months ended June 30, 2026 and 2025, respectively. The increase was primarily due to higher EDG-7500, EDG-15400 and internal personnel-related costs, partially offset by lower discovery and preclinical expenses, and was attributed to the following:
● an increase in EDG-7500 clinical program expenses of $6.6 million primarily related to an increase of $1.6 million from completion of patient activity for Part D of our multipart Phase 2 CIRRUS-HCM trial, for which Part B and Part C were completed enrollment and Part D was enrolling in the comparable period in 2025, a $2.3 million increase in other development costs primarily driven by nonclinical costs and manufacturing costs to support future trials, and an increase of $2.7 million from pharmacokinetic studies;
● an increase in EDG-15400 clinical program expenses of $6.5 million which are now shown separately in the above table due to advancing into a Phase 1 trial in the third quarter of 2025. These expenses include clinical trial and nonclinical costs, as well as manufacturing costs to support current and future trials; and
● an increase in internal costs of $8.6 million, primarily related to personnel-related costs, including stock-based compensation, resulting from increased employee headcount to support the growth of our research and development programs;
partially offset by:
● a decrease of $0.7 million in sevasemten clinical program expenses, which was primarily related to a $1.9 million decrease in spend related to a pharmacokinetic study which was completed in 2025, a $0.6 million decrease in clinical program expenses in CANYON and GRAND CANYON compared to the same period in 2025 due to patient rollover to the MESA trial. This was offset by a $1.6 million increase in clinical program expenses in the MESA trial related to increased clinical activity due to continued patient rollover from the GRAND CANYON trial; and
● a decrease in discovery and preclinical expenses of $1.0 million, which was primarily driven by a decrease in EDG-15400 related costs, now shown separately, which were a significant portion of discovery, preclinical, and nonclinical expenses in the comparable period in 2025.
Following completion of the Sevasemten Sale on July 10, 2026, we do not expect direct external clinical program costs associated with sevasemten to continue, except for retained obligations and transition-services activities performed under the Transition Services Agreement.
General and administrative expenses
General and administrative expenses increased to $25.9 million for the six months ended June 30, 2026 compared to $18.3 million for the six months ended June 30, 2025. The increase of $7.6 million was primarily attributable to $3.0 million in increased personnel-related costs, including stock-based compensation, associated with organizational growth, $2.1 million in increased costs associated with commercial readiness activities for sevasemten, as well as $2.5 million in increased professional and consulting costs, transaction costs related to the Sevasemten Sale, and other administrative costs supporting public company operations and clinical development activities.
Interest income
Interest income was $9.7 million for the six months ended June 30, 2026 compared to $11.7 million for the six months ended June 30, 2025. Interest income reflects returns generated from the investment of our cash, cash equivalents and marketable securities in accordance with our investment policies and may fluctuate in future periods based on prevailing market conditions and the timing of cash deployment.
Liquidity and Capital Resources
Sources of liquidity
Since our inception, we have not generated any revenue and have incurred significant operating losses and negative cash flows from our operations. To date, we have financed our operations primarily through private placements of
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convertible preferred stock and public offerings of our common stock. From inception to our initial public offering, private placements provided gross proceeds of $160.7 million, and, as of June 30, 2026, we generated net proceeds from our initial public offering, follow-on public offering, issuance of our common stock under the ATM Program, and the January 2024 and April 2025 underwritten registered direct offerings of $793.7 million. Additionally, pursuant to the Sevasemten Purchase Agreement, we completed the sale of sevasemten and our muscular dystrophy program to Servier on July 10, 2026 and received upfront cash consideration of $1,550 million. As of June 30, 2026, we had cash, cash equivalents and marketable securities in the amount of $460.7 million.
Cash flows
The following table summarizes our sources and uses of cash for each of the periods presented:
Six months ended June 30,
2026 2025
(in thousands)
Net cash used in operating activities $ (85,012) $ (70,448)
Net cash provided by (used in) investing activities 80,923 (118,268)
Net cash provided by financing activities 15,260 190,454
Net increase in cash and cash equivalents $ 11,171 $ 1,738
Operating activities
Cash used in operating activities during the six months ended June 30, 2026 was $85.0 million primarily driven by our net loss for the period of $106.3 million, and was also impacted by changes in operating assets and liabilities, which decreased net working capital by $3.9 million. Cash used in operating activities was reduced by non-cash charges of $17.4 million relating to stock-based compensation expense of $18.1 million, depreciation of $1.1 million, and amortization of right-of-use asset of $0.1 million, offset by accretion of discounts, net on marketable securities of $1.8 million.
Cash used in operating activities during the six months ended June 30, 2025 was $70.4 million primarily driven by our net loss for the period of $76.9 million, and was also impacted by changes in operating assets and liabilities, which increased net working capital by $7.3 million. Cash used in operating activities was reduced by non-cash charges of $13.8 million relating to stock-based compensation expense of $16.8 million, accretion of discounts, net on marketable securities of $4.1 million, depreciation of $1.0 million, and amortization of right-of-use asset of $0.1 million.
Investing activities
Cash provided by investing activities during the six months ended June 30, 2026 amounted to $80.9 million, due to $217.7 million in maturities of marketable securities and $26.8 million in sales of marketable securities, which were partially offset by $163.2 million in purchases of marketable securities and $0.3 million for purchases of equipment.
Cash used in investing activities during the six months ended June 30, 2025 amounted to $118.3 million, due to $385.9 million in purchases of marketable securities and $0.1 million for purchases of equipment, which was partially offset by $229.1 million in maturities of marketable securities and $38.7 million in sales of marketable securities.
Financing activities
Cash provided by financing activities during the six months ended June 30, 2026 was $15.3 million due to cash proceeds of $14.5 million from the issuance of common stock upon exercise of stock options and $0.8 million in proceeds from the Company’s 2021 Employee Stock Purchase Plan (2021 ESPP).
Cash provided by financing activities during the six months ended June 30, 2025 was $190.5 million, due to cash proceeds of $200.0 million from the April 2025 underwritten registered direct offering, $2.5 million in proceeds from the
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issuance of common stock upon exercise of stock options, $0.6 million in proceeds from the Company’s 2021 Employee Stock Purchase Plan (2021 ESPP), which was partially offset by $12.6 million for the payment of underwriting discounts and commissions and offering costs.
Impact of the Sevasemten Sale
On July 10, 2026, we completed the Sevasemten Sale and received $1,550 million in upfront cash proceeds. As a result, our available liquidity increased materially after June 30, 2026. In the quarter ending September 30, 2026, we expect to recognize a gain on the sale within other income, subject to final closing-date carrying values of the assets transferred and liabilities assumed, transaction costs, and the related income tax effects. We also expect our future operating expenses to be affected by the elimination of direct sevasemten program costs that will not continue following the sale, partially offset by costs and reimbursements associated with the Transition Services Agreement. Any contingent milestone payments will be recognized only if and when the applicable recognition criteria are met.
Funding requirements
We may continue to require substantial additional capital to develop our product candidates and fund operations for the foreseeable future. On May 10, 2024, we filed an automatic shelf registration statement on Form S-3ASR that allows us to undertake various equity and debt offerings and entered into the Leerink Sales Agreement under which we may offer and sell shares of common stock, having aggregate sales proceeds of up to $175.0 million from time to time, through the Leerink ATM.
On May 31, 2026, the Company entered into the Sevasemten Purchase Agreement, pursuant to which Servier acquired sevasemten and certain other related assets collectively constituting the Company’s muscular dystrophy program and assumed certain related liabilities for aggregate potential consideration of up to $2,650 million. On July 10, 2026, the Company completed the Sevasemten Sale receiving $1,550 million in upfront cash proceeds and is eligible to receive up to $1,100 million in potential future milestone payments, including (a) a potential milestone payment upon achieving U.S. marketing approval for sevasemten for Becker muscular dystrophy in the amount of (i) $200 million, in cash, payable in the event of an approved labelling including specified adult and adolescent populations or (ii) $100 million in cash, payable in the event of an approved labelling including only specified adult populations (if (i) has not previously been achieved); (b) a potential milestone payment of $600 million in cash, payable upon the achievement of U.S. marketing approval for sevasemten for Duchenne muscular dystrophy; and (c) a potential milestone payment of $300 million in cash, payable upon the achievement of annual U.S. net sales of sevasemten products exceeding $550 million.
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the development of and seek regulatory approvals for our product candidates and begin to commercialize any approved products. We are subject to all of the risks incident in the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. In addition, we expect to continue to incur additional costs associated with operating as a public company. Our expenses will also increase if, and as, we:
● advance our product candidates through preclinical and clinical development;
● seek regulatory approvals for any product candidates that successfully complete clinical trials;
● continue to invest in our proprietary drug discovery platform;
● seek to discover and develop additional product candidates;
● establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any product candidates for which we may obtain marketing approval and intend to commercialize on our own or jointly;
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● hire additional clinical, quality control, scientific and other personnel;
● expand our operational, financial and management systems and increase personnel including personnel to support our clinical development, manufacturing and commercialization efforts and our operations as a public company;
● maintain, expand, protect and enforce our intellectual property portfolio; and
● acquire or in-license other product candidates and technologies.
We do not currently have any long-term material capital requirements other than what will be required to fund operations for the foreseeable future and the amounts disclosed on the contractual obligations and commitments section below. In order to complete the process of obtaining regulatory approval for our product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we may require substantial additional funding.
We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount and timing of our working capital requirements. Our future funding requirements will depend on many factors, including:
● the scope, progress, results and costs of researching and developing our product candidates including:
o conducting preclinical studies and clinical trials;
o the costs, timing and outcome of regulatory review of our product candidates;
o the number and characteristics of other product candidates that we pursue;
o the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;
o the costs of manufacturing products of consistent quality and obtaining sufficient inventory to support commercial launch;
o the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;
o the cost and timing of hiring new employees to support our continued growth;
● the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
● the effect of competing products that may limit market penetration of our products;
● the ability to establish and maintain collaborations on favorable terms, if at all;
● the extent to which we acquire or in-license other product candidates and technologies;
● the timing, receipt and amount of sales of, or milestone payments related to or royalties on, our current or future product candidates, if any;
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● our need to implement additional internal systems and infrastructure, including financial and reporting systems;
● the compliance and administrative costs associated with being a public company;
● the effects of inflation on our business operations; and
● the extent to which we acquire or invest in businesses, products, or technologies, although we currently have no commitments or agreements relating to any of these types of transactions.
A change in the outcome of any of these or other factors with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.
If we are unable to raise additional funds when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts. We may also be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
The issuance of additional equity securities may cause our stockholders to experience dilution. Future equity or debt financings may contain terms that are not favorable to us or our stockholders including debt instruments imposing covenants that restrict our operations and limit our ability to incur liens, issue additional debt, pay dividends, repurchase our common stock, make certain investments or engage in merger, consolidation, licensing or asset sale transactions.
Operating and Capital Expenditure Requirements and Contractual Obligations
We expect that our existing cash and cash equivalents and marketable securities, will be sufficient to enable us to fund our planned operating expenses and capital expenditure requirements through at least the next 12 months.
Our short-term material cash requirements as of June 30, 2026 are to fund our operations, which consist primarily of research and development expenses related to our programs, and to a lesser extent, general and administrative expenses. We have entered into contracts in the normal course of business with CROs, CDMOs and other third parties for preclinical research studies and testing, clinical trials and manufacturing services. These contracts do not contain any minimum purchase commitments and are cancelable by us upon prior notice. Payments due upon cancellation consist only of payments for services provided and expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation.
Our long-term cash requirements as of June 30, 2026 includes our lease obligations. In January 2022, we entered into a lease agreement for approximately 18,614 square feet of office and laboratory space in Boulder, Colorado which includes escalating rent payments and an 8.2 year term, plus our share of operating expenses. In February 2023, the lease was modified to occupy an additional 9,624 square feet of office space, with aggregate payments of approximately $1.5 million over the initial 7.3 year term, plus our share of operating expenses. As of June 30, 2026, our total operating lease liability balance is $3.6 million, of which $1.0 million is a current liability.
Critical Accounting Estimates
Our financial statements are prepared in accordance with generally accepted accounting principles in the United States and requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, costs, expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on a periodic basis. Our actual results may differ from these estimates.
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Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2026 and the notes to the financial statements appearing elsewhere in this Quarterly Report. During the three and six months ended June 30, 2026, there were no material changes to our critical accounting estimates from those discussed in our Annual Report on Form 10-K filed on February 26, 2026.
Recently Issued Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our financial statements appearing in this Quarterly Report.