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You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited interim condensed financial statements and related notes included elsewhere in this Quarterly Report and audited financial statements and notes thereto as of and for the year ended December 31, 2025 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 Annual Report”), filed with the SEC on March 9, 2026. This discussion and other parts of this Quarterly Report contain forward-looking statements based upon current beliefs, plans, and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements of our plans, objectives, expectations, intentions, forecasts and projections. Our actual results and the timing of selected events could differ materially from those discussed in these forward-looking statements as a result of several factors including, but not limited to, those set forth under the section titled “Risk Factors” and elsewhere in this Quarterly Report and in our other filings with the SEC. Our historical results are not necessarily indicative of the results that may be expected for any period in the future, and you should carefully read the section titled “Risk Factors” in this Quarterly Report to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”
Overview
We are a clinical-stage biotechnology company pioneering a new era of GPCR oral small molecule drug discovery powered by our proprietary Native Complex Platform®. Our industrial-scale platform aims to unlock the full potential of GPCR therapies and has led to the discovery and development of our deep pipeline of drug candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases.
Our proprietary Native Complex Platform® replicates the natural structure, function, and dynamics of GPCRs outside of cells at an industrial scale for, as we believe it, the first time. Our foundational technologies enable us to isolate, purify, and reconstitute full-length, properly folded GPCR proteins within ternary complexes with ligands and transducer proteins in a lipid bilayer that mimics the cell membrane. We then apply state-of-the-art discovery tools and technologies to these defined and tunable protein complexes to structurally design, screen for, and optimize potential product candidates. Leveraging our platform, we conduct GPCR oral small molecule drug discovery using an industrialized and iterative structure-based drug design approach for a diverse collection of GPCR targets. Our Native Complex Platform® is designed to enable us to target specific GPCRs, uncover novel binding pockets for validated receptors, and pursue a wide spectrum of pharmacologies, including agonists (which activate GPCR signaling), antagonists (which inhibit GPCR signaling), and allosteric modulators (which either increase or decrease the degree of GPCR activation by endogenous ligands), to affect GPCR signaling in different ways to achieve desired therapeutic effects.
We are advancing a deep portfolio of oral small molecule GPCR-targeted programs with novel mechanistic approaches to treat diseases across multiple therapeutic areas for patients with significant unmet needs. Our pipeline of wholly-owned and partnered programs is summarized in the figure below.
*Partnership includes two undisclosed targets.
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Recent Developments
•SEP-479 PTH1R Agonist Program:
oOn April 13, 2026, we announced the dosing of the first participants in our Phase 1 clinical trial of SEP-479, our oral small molecule PTH1R agonist being developed for the treatment of patients with hypoparathyroidism. The Phase 1 clinical trial is a single-ascending dose (“SAD”) and multiple-ascending dose (“MAD”) clinical trial to evaluate the safety, tolerability, pharmacokinetics (“PK”) and pharmacodynamics (“PD”) of SEP-479 in healthy adult volunteers. The randomized, placebo-controlled Phase 1 clinical trial is expected to enroll up to 150 healthy adult participants. The SAD portion of the clinical trial will evaluate the safety and tolerability of SEP-479 at escalating oral doses. The MAD portion of the clinical trial is designed to evaluate the safety and tolerability of once-daily oral dosing of SEP-479 over multiple days of treatment, with secondary and exploratory endpoints including PK and PD, with the latter assessed by changes in endogenous PTH and serum calcium, as well as other biomarkers. Based on pharmacokinetic data from the ongoing Phase 1 clinical trial, the observed terminal half-life of SEP-479 is approximately three to four days, which we anticipate will support once-daily dosing. To fully characterize steady-state pharmacokinetics, dosing for the MAD cohorts will be extended to 14 days. As a result, we expect to report Phase 1 data from both the SAD and MAD cohorts in the first quarter of 2027.
•SEP-631: Oral Small Molecule MRGPRX2 Negative Allosteric Modulator for Mast Cell-Driven Diseases
oWe had previously planned to initiate a Phase 2b global, randomized, double-blind, placebo-controlled clinical trial to evaluate safety and exploratory efficacy of SEP-631 in chronic spontaneous urticaria (“CSU”) in the second half of 2026. Based on emerging clinical data in the MRGPRX2 field, in lieu of a Phase 2b clinical trial in CSU, we are now evaluating development strategies for capital-efficient, signal-finding clinical trials for SEP-631 for mast cell driven diseases characterized by high unmet need.
Financial Overview
We have incurred significant operating losses since our inception, except for the year ended December 31, 2023. Our revenue to date has been generated solely from research services. Since our founding, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, developing our proprietary and structure-based drug discovery platform, identifying and discovering our product candidates, establishing our intellectual property portfolio, conducting research and preclinical studies, including IND-enabling studies, initiating and conducting clinical trials, establishing arrangements with third parties for the manufacture of our product candidates and related raw materials, and providing general and administrative support for these operations. We have not had any products approved for sale and have not generated any revenue from product sales. Further, we do not expect to generate revenue from commercial product sales until such time, if ever, that we are able to successfully complete the development and obtain marketing approval for one or more of our product candidates. Our ability to generate product revenue will depend on the successful development and eventual commercialization of one or more of our product candidates.
Our net loss was $21.7 million and $46.3 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $188.9 million. We have incurred net losses in each year since inception, except for the year ended December 31, 2023. We expect to continue to incur net losses for the foreseeable future. Our net losses may fluctuate significantly from period to period, depending on the timing and expenditures of our operational activities.
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We expect to continue to incur significant and increasing net operating losses for the next several years as we:
•continue to advance our product candidates through preclinical studies and into clinical trials;
•attract, hire and retain additional personnel;
•continue to operate as a public company, including expenses related to compliance with the rules and regulations of the SEC and those of any national securities exchange on which our securities are traded, legal, auditing, insurance expenses, investor relations activities, and other administrative and professional services;
•continue our research and development efforts and expand our pipeline of product candidates;
•acquire, discover, validate, and develop additional product candidates;
•manufacture supplies for our preclinical studies and clinical trials;
•obtain, maintain, expand, and protect our intellectual property portfolio;
•implement operational, financial and information management systems;
•make royalty, milestone or other payments under any future, license or collaboration agreements;
•potentially seek to identify, assess, acquire, or in-license or develop new technologies or additional product candidates;
•potentially experience any delays, challenges, or other issues associated with the clinical development of our product candidates, including with respect to our regulatory strategies;
•pursue regulatory approval of product candidates that successfully complete clinical trials; and
•establish a sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain marketing approval and related commercial manufacturing build-out.
Our net losses may fluctuate significantly from period to period, depending upon the timing of our expenditures on research and development activities. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses and other current liabilities, which includes accrued research and development, in the condensed statements of cash flows included elsewhere in this Quarterly Report.
As a result, we will require substantial additional funding to further develop our product candidates and support our continuing operations. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. See the section titled “Liquidity and Capital Resources - Future Funding Requirements” below for additional information.
We have historically financed our operations primarily through the issuances of convertible promissory notes and convertible preferred stock, sales of our common stock, and collaboration arrangements with other companies. In March 2026, we entered into an ATM Equity OfferingSM Sales Agreement (the “Sales Agreement”) with BofA Securities, Inc., acting as our sales agent and/or principal (the “Sales Agent”) with respect to an “at-the-market offering” program pursuant to which we may, from time to time, at our sole discretion, issue and sell shares of our common stock having an aggregate offering price of up to $150.0 million through the Sales Agent (the “ATM Program”).
During the three and six months ended June 30, 2026, we sold 380,172 shares of common stock under the ATM Program at a weighted average price of $36.34 per share, generating net proceeds of $13.8 million. Subsequently, in July 2026, the Company sold an additional 935,730 shares of common stock under the ATM Program for net proceeds of $33.7 million. Sales commissions incurred under the ATM Program were immaterial.
We believe our cash, cash equivalents, and marketable securities of $516.5 million as of June 30, 2026 will be sufficient to fund our operations and capital expenditure requirements at least into 2029.
We use contract research and development organizations to conduct our preclinical works and clinical trials. Additionally, we utilize third-party CMOs, to manufacture and supply our preclinical and clinical materials during the development of our product candidates. We expect to use similar contract resources for the commercialization of our products, at least until our resources and operations are at a scale that justifies investment in internal manufacturing capabilities.
We conduct research and manufacturing work outside of the United States, including China, that may be affected by tariffs, including tariffs that have been or may in the future be imposed by the United States or other countries through reciprocal tariffs. While we do not currently believe tariffs will have a material impact on our business or results of operations, we will continue to carefully monitor the situation. Additionally, we continue to actively monitor macroeconomic conditions and market volatility resulting from global and national economic developments, political unrest, inflationary pressures, interest rate fluctuations, disruptions in capital markets, changes in international trade relationships, changes in or the disruptions of U.S. governmental agencies, whether from a future U.S. federal government shutdown or reduced resources, new laws and regulations or amendments to existing laws and regulations in
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the U.S. and foreign countries, and military conflicts, such as the ongoing conflicts in Iran, Ukraine and the Middle East. While we believe such factors have had no significant impact on our business or financial results during the periods presented, future developments and potential impacts on our business are uncertain and cannot be predicted with confidence.
Collaboration, Research Services and Asset Purchase Agreements
Novo Collaboration Agreement
In May 2025, we entered into a global Collaboration and License Agreement with Novo (the "Novo Collaboration Agreement"). Under the Novo Collaboration Agreement, we and Novo are exclusively collaborating to leverage our proprietary Native Complex Platform® to discover, develop and commercialize multiple potential oral small molecule therapies for metabolic-related diseases based on certain specified molecular targets. The collaboration objective is to discover and develop several novel mono-, dual-, or triple-acting oral small molecule drug candidates directed across five GPCRs, including the GLP-1, GIP, and glucagon receptors (the "Collaboration Targets"). The collaboration includes our most advanced preclinical metabolic program focused on developing an oral small molecule agonist to the GIP receptor. We and Novo have initially commenced four simultaneous research and development programs (each an “R&D Program”) with each pursuing one or more Collaboration Targets from discovery through development candidate selection. In July 2026, we completed our performance obligations for the first R&D Program and provided Novo with the first development candidate. Novo then exercised its right to commence another R&D Program as one of the four programs that can be pursued simultaneously under the collaboration.
In July 2025, the Novo Collaboration Agreement became effective and, subsequently, we received a one-time, non-refundable upfront payment of $195.0 million, which was recorded as deferred revenue in our condensed balance sheet. For each R&D Program, we are also eligible to receive up to approximately $498.0 million in research, development, regulatory, and commercial milestone payments. In addition, we are entitled to escalating, tiered royalties ranging from mid-to-high single-digits based on global product sales on a country-by-country and product-by-product basis with respect to a R&D Program until the later of ten years after the date of first commercial sale of the first product in such R&D Program in such country, expiration of specified patent rights covering such product in such country or the expiration of specified regulatory exclusivity for the first product in such R&D Program in such country.
For the six months ended June 30, 2026, our revenue was derived solely from research activities performed for Novo under the Novo Collaboration Agreement. As of June 30, 2026, our accounts receivable was entirely attributed to Novo. See Note 3 to the unaudited condensed financial statements in this Quarterly Report for additional information.
Vertex Research Service Agreement
In connection with the entry into an asset purchase agreement with Vertex in September 2023, we also entered into a research service agreement with Vertex (“Vertex Research Service Agreement”) under which we agreed to perform certain exploratory research activities for Vertex. For the six months ended June 30, 2025, our revenue was derived solely from research activities performed for Vertex under the Vertex Research Service Agreement. The Vertex Research Service Agreement expired in September 2025.
Components of Results of Operations
Revenue
We have not generated any revenue from product sales and do not expect to do so in the foreseeable future. Our ability to generate product revenue, if ever, will depend on the successful development and eventual commercialization of any product candidates that we identify. If we fail to complete the development of any future product candidates in a timely manner or to obtain regulatory approval for such product candidates, our ability to generate future revenue and our results of operations and financial position would be materially adversely affected. Our revenues to date have been exclusively related to license and research and development (“R&D”) services and achievement of milestones. Our license and research service revenue consists of amounts recognized from the portions of the non-refundable upfront payment and R&D services performed by us.
Operating Expenses
Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.
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Research and Development
Research and development expenses account for the largest component of our total operating expenses. Research and development expenses consist primarily of direct and unallocated costs incurred for the research and development of our product candidates. Our research and development expenses consist of:
•direct costs, including:
▪clinical program costs, which include external costs to conduct clinical trials, including costs paid to CROs, the production of clinical materials and fees paid to contract manufacturers, costs incurred in connection with clinical laboratory operations, materials and supplies;
▪preclinical and research program costs, which include external research and development costs related to (i) the production of preclinical materials, including fees and milestones paid to contract manufacturers and (ii) agreements with contract development organizations, consultants and other third-party contract organizations to conduct our preclinical studies and other research and development activities on our behalf, costs incurred in connection with laboratory operations, materials and supplies, and other preclinical studies; and
•unallocated costs, including:
▪payroll-related costs, including salaries, benefits and stock-based compensation for employees engaged in research and development activities;
▪external research and development costs, including contract research and development and professional service fees for consulting and related services;
▪facility-related and office costs, including lease/rent, building-related expenses, facility-related overhead, and depreciation expense; and
▪other costs, including expenses related to our funded, sponsored research activities and technology licenses, laboratory operations, information technology (“IT”)-related expenses
We expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and third-party service providers.
A significant portion of our research and development costs have been external costs, which we track by stage of development. However, we do not track our unallocated costs on a program specific basis because these costs are deployed across multiple projects and, as such, are not separately classified.
At this time, we cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates. We expect that our research and development expenses will increase substantially in absolute dollars for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, as our product candidates advance into later stages of development, as we begin to conduct new clinical trials, as we seek regulatory approvals for any product candidates that successfully complete clinical trials, and as we incur expenses associated with hiring additional personnel to support our research and development efforts. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. This is due to the numerous risks and uncertainties associated with developing product candidates, many of which are outside of our control, including the uncertainty of:
•the scope, 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;
•the number of sites and patients included in the clinical trials;
•the countries in which the clinical trials are conducted;
•our ability to replicate positive results from a completed clinical study in a future clinical study;
•per patient trial costs;
•successful patient enrollment in, and the initiation of, clinical trials, as well as drop out or discontinuation rates;
•the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to FDA, European Medicines Agency (“EMA”), or any other comparable foreign regulatory authorities;
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•delays or disruptions in review, approval, inspection, or other actions by the FDA or other applicable U.S. or foreign government regulatory authorities that could impact the timing, initiation, conduct, or completion of our clinical trials or marketing applications;
•the number of trials required for regulatory approval;
•the timing, receipt and terms of any regulatory approvals from applicable regulatory authorities;
•our ability to maintain existing collaborations and strategic relationships, to identify and establish any future collaboration arrangements on favorable terms, if at all, and to realize the intended and potential benefits of such agreements and collaborations;
•the performance of any current or future collaborators;
•establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
•significant and changing government regulation and regulatory guidance;
•the impact of any business interruptions to our operations or to those of the third parties with whom we work;
•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 regulatory approval.
Any changes in the outcome of any of these variables could mean a significant change in the costs and timing associated with the development of our product candidates. For example, if the FDA, EMA or any other comparable foreign regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development. We may never obtain regulatory approval for any of our product candidates.
General and Administrative
General and administrative expenses consist primarily of personnel-related costs, costs related to maintenance and filing of intellectual property, legal fees related to corporate matters, professional fees paid for accounting, auditing, consulting, tax and investor relations services, insurance costs, general corporate expenses, and IT-related and facility-related costs not otherwise included in research and development expenses. Personnel-related costs include salaries, benefits, and stock-based compensation for our personnel in executive, legal, finance and accounting, human resources, and other administrative functions.
We expect that our general and administrative expenses will increase in absolute dollars for the foreseeable future as we continue to increase our headcount to support our business growth and to advance our research and development programs.
Other Income, Net
Interest Income
Interest income consists of interest earned on our cash, cash equivalents and marketable securities during the period.
Other Expense, Net
Other expense, net consists primarily of changes in the fair value of our cash equivalents held in money market funds, loss on disposal of our fixed assets and foreign currency transaction gain or loss.
Provision for Income Taxes
We are subject to corporate U.S. federal and state income taxation. Our provision for income taxes is recorded in accordance with Accounting Standard Codification 740, Accounting for Income Taxes, which provides for deferred taxes using an asset and liability approach. We establish a valuation allowance against all of our net deferred tax assets. We consider all available evidence, both positive and negative, including but not limited to our historical operating results, income or loss in recent periods, cumulative losses in recent years, forecasted earnings (losses), future taxable income (loss), and significant risk and uncertainty related to forecasts, and concluded the deferred tax assets are not more likely than not to be realized.
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Results of Operations
Comparison of the Three and Six Months Ended June 30, 2026 and 2025
Our results of operations for each of the periods indicated are summarized in the table below (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2026 2025 Change 2026 2025 Change
Revenue $ 26,746 $ 119 $ 26,627 $ 53,269 $ 338 $ 52,931
Operating expenses:
Research and development 35,132 22,188 12,944 64,667 41,459 23,208
General and administrative 8,450 6,909 1,541 18,738 13,767 4,971
Total operating expenses 43,582 29,097 14,485 83,405 55,226 28,179
Loss from operations (16,836 ) (28,978 ) 12,142 (30,136 ) (54,888 ) 24,752
Other income, net:
Interest income 4,798 4,165 633 9,829 8,627 1,202
Other expense, net (23 ) (25 ) 2 (54 ) (53 ) (1 )
Total other income, net 4,775 4,140 635 9,775 8,574 1,201
Loss before provision for income taxes (12,061 ) (24,838 ) 12,777 (20,361 ) (46,314 ) 25,953
Provision for income taxes (973 ) — (973 ) (1,310 ) — (1,310 )
Net loss $ (13,034 ) $ (24,838 ) $ 11,804 $ (21,671 ) $ (46,314 ) $ 24,643
Revenue
Our total revenue of $26.7 million for the three months ended June 30, 2026 was generated from research activities performed for Novo, of which $14.6 million was recognized from deferred revenue associated with the upfront payment from Novo, $11.2 million of variable consideration related to estimated research services, and $0.9 million associated with the recognition of revenue for four collaboration target milestones achieved as of June 30, 2026. All of our revenue for the three months ended June 30, 2025 was generated from research activities performed for Vertex.
Our total revenue of $53.3 million for the six months ended June 30, 2026 was generated from research activities performed for Novo, of which $30.3 million was recognized from deferred revenue associated with the upfront payment from Novo, $21.5 million of variable consideration related to estimated research services, and $1.4 million associated with the recognition of revenue for four collaboration target milestones achieved as of June 30, 2026. All of our revenue for the six months ended June 30, 2025 was generated from research activities performed for Vertex.
Operating Expenses
Research and Development
The following table summarizes our research and development expenses for the periods indicated by direct and unallocated costs (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2026 2025 Change 2026 2025 Change
Direct costs:
PTH1R $ 4,936 $ 2,524 $ 2,412 $ 7,290 $ 6,733 $ 557
SEP-631 (MRGPRX2) 2,043 2,743 (700 ) 4,508 3,765 743
Partnered metabolic programs 6,600 — 6,600 12,130 — 12,130
Other discovery and preclinical programs 7,198 5,796 1,402 11,289 9,996 1,293
Unallocated costs:
Payroll-related costs 9,719 6,320 3,399 19,840 11,733 8,107
Facility-related and office costs 2,163 2,050 113 4,406 3,976 430
External research and development costs 616 1,227 (611 ) 1,534 2,473 (939 )
Other costs 1,857 1,528 329 3,670 2,783 887
Total research and development expense $ 35,132 $ 22,188 $ 12,944 $ 64,667 $ 41,459 $ 23,208
Research and development expenses were $35.1 million and $22.2 million for the three months ended June 30, 2026 and 2025, respectively. The increase was primarily due to $9.7 million of higher direct costs associated with our clinical, discovery and preclinical programs, which includes $6.6 million of higher costs associated with our partnered metabolic programs as we commenced our research
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activities for these programs in July 2025, $2.4 million of higher costs associated with the advancement of our PTH1R program into the clinic, $1.4 million of higher costs associated with our other preclinical and discovery programs as we continue to advance these programs, and $0.7 million of lower costs associated with our SEP-631 program mainly as a result of lower research and preclinical study costs. The increase was also driven by (i) $3.4 million of higher employee-related costs as a result of increased headcount to support the expansion of our research and development activities, which includes $1.3 million of higher stock-based compensation expenses as a result of additional new equity grants during the period, and (ii) $0.3 million in other research and development expense, partially offset by $0.6 million of lower unallocated external research and development costs.
Research and development expenses were $64.7 million and $41.5 million for the six months ended June 30, 2026 and 2025, respectively. The increase was primarily due to $14.7 million of higher direct costs associated with our clinical, discovery and preclinical programs, which includes $12.1 million of higher costs associated with our partnered metabolic programs as we commenced our research activities for these programs in July 2025, $1.3 million of higher costs associated with our other preclinical and discovery programs as we continue to advance these programs, and $0.7 million and $0.6 million, respectively, of higher costs associated with the advancement of our SEP-631 and PTH1R programs. The increase was also driven by (i) $8.1 million of higher employee-related costs as a result of increased headcount to support the expansion of our research and development activities, which includes $3.1 million of higher stock-based compensation expenses as a result of additional new equity grants during the period, (ii) $0.9 million in other research and development expense, and (iv) $0.4 million of higher facility-related and office costs, partially offset by $0.9 million of lower unallocated external research and development costs.
We expect research and development expenses to continue to increase as we advance SEP-631, SEP-479, and other programs in our pipeline.
General and Administrative
General and administrative expenses were $8.5 million and $6.9 million for the three months ended June 30, 2026 and 2025, respectively, primarily due to $2.0 million of higher employee-related costs as a result of increased headcount to support the growth of our operations. This amount includes $1.9 million of higher stock-based compensation expenses as a result of additional new grants during the period.
General and administrative expenses were $18.7 million and $13.8 million for the six months ended June 30, 2026 and 2025, respectively, primarily due to $5.5 million of higher employee-related costs as a result of increased headcount to support the growth of our operations. This amount includes $4.7 million of higher stock-based compensation expenses mainly as a result of additional new grants during the period.
Other Income, Net
Interest Income
Interest income was $4.8 million and $4.2 million for the three months ended June 30, 2026 and 2025, respectively. Interest income was $9.8 million and $8.6 million for the six months ended June 30, 2026 and 2025, respectively. The increase was due to higher interest rates and higher balances of cash equivalents and marketable securities.
Provision for Income Taxes
We recorded $1.0 million and $1.3 million of provision for income taxes for the three and six months ended June 30, 2026, respectively. We did not record any benefit or provision for income taxes for the three and six months ended June 30, 2025.
Liquidity and Capital Resources
Sources of Liquidity
Our net losses were $21.7 million and $46.3 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $188.9 million. We expect to continue to incur net losses for the foreseeable future. Our net losses may fluctuate significantly from period to period, depending on the timing and expenditures of our operational activities.
We have historically financed our operations primarily through the issuances of convertible promissory notes and convertible preferred stock, sales of our common stock, and strategic collaborations with other companies. In March 2026, we entered into the Sales Agreement for the ATM Program under which we may sell shares of our common stock having an aggregate offering price of up to $150.0 million. During the three and six months ended June 30, 2026, we sold 380,172 shares of common stock under the ATM Program at a weighted average price of $36.34 per share, generating net proceeds of $13.8 million. See Note 6 to the unaudited condensed financial statements in this Quarterly Report for additional information.
As of June 30, 2026, we had $516.5 million in cash, cash equivalents, and marketable securities, which, we believe, will be sufficient to fund our operations and capital expenditure requirements at least into 2029.
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We do not have any material off-balance sheet arrangements other than our indemnification agreements as described in Note 5 to our unaudited condensed financial statements included elsewhere in this Quarterly Report.
Cash Flows
The following table summarizes our cash flows for the periods indicated (in thousands):
Six Months Ended June 30,
2026 2025
Net cash used in operating activities $ (47,812 ) $ (43,630 )
Net cash used in investing activities (5,405 ) (5,660 )
Net cash provided by financing activities 17,157 405
Net decrease in cash, cash equivalents and restricted cash $ (36,060 ) $ (48,885 )
Net Cash Used in Operating Activities
Net cash used in operating activities of $47.8 million for the six months ended June 30, 2026 was due to our net loss of $21.7 million and $38.0 million of net change in operating assets and liabilities, partially offset by $11.9 million of non-cash charges for depreciation and amortization, stock-based compensation, non-cash operating lease expense and accretion of discounts, net, on marketable securities.
Net cash used in operating activities of $43.6 million for the six months ended June 30, 2025 was due to our net loss of $46.3 million and $0.5 million of net change in operating assets and liabilities, partially offset by $3.2 million of non-cash charges for depreciation and amortization, stock-based compensation, non-cash operating lease expense and accretion of discounts, net, on marketable securities.
Net Cash Used in Investing Activities
Net cash used in investing activities of $5.4 million for the six months ended June 30, 2026 was due to $152.8 million of purchases of marketable securities and $0.8 million of purchases of property and equipment, partially offset by the maturity of $148.2 million of marketable securities.
Net cash used in investing activities of $5.7 million for the six months ended June 30, 2025 was due to $113.6 million of purchases of marketable securities and $0.4 million of purchases of property and equipment, partially offset by the maturity of $108.3 million of marketable securities.
Net Cash Provided by Financing Activities
Net cash provided by financing activities of $17.2 million for the six months ended June 30, 2026 was due to $13.8 million in net proceeds from sales under the ATM Program, combined with $3.4 million in proceeds from the exercise of stock options and the purchase of shares under the employee stock purchase plan.
Net cash provided by financing activities of $0.4 million for the six months ended June 30, 2025 was due to proceeds from the exercise of stock options.
Future Funding Requirements
Our primary use of cash, cash equivalents, and marketable securities is to fund our operations, primarily research and development expenditures. Cash, cash equivalents, and marketable securities used for operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
•the scope, timing, progress and results of discovery, preclinical development, laboratory testing and clinical trials for our product candidates;
•our ability to successfully develop, obtain regulatory and marketing approvals of our product candidates for the expected indications and patient populations;
•the expenses of manufacturing our product candidates for clinical trials and in preparation for marketing approval and commercialization;
•our ability to maintain existing collaborations or strategic relationships and the extent to which we identify and enter into future collaborations or other arrangements with additional third parties in order to further develop our product candidates, as well as our ability to realize the intended and potential benefits of such agreements and collaborations;
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•regulatory or legal developments in the United States and other countries;
•the expenses of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
•the expenses and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies;
•our ability to establish additional collaborations on favorable terms, if at all;
•the expenses required to scale up our clinical, regulatory and manufacturing capabilities;
•the expenses of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities, for any of our product candidates for which we receive marketing approval; and
•revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval.
We will need additional funds to meet operational needs and capital requirements for clinical trials, other research and development expenditures, and business development activities. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical studies.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of private and public equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. However, the trading prices for our common stock and for other biopharmaceutical companies have been highly volatile. As a result, we may face difficulties raising capital through sales of our common stock, and such sales may be on unfavorable terms. Similarly, adverse macroeconomic conditions and market volatility resulting from global and national economic developments, concerns regarding a potential global recession, political unrest, military conflicts, such as the ongoing conflicts in Iran, Ukraine and the Middle East, inflationary pressures, disruptions in capital markets, changes in international trade relationships, changes in or the disruptions of U.S. governmental agencies, whether from a future U.S. federal government shutdown or reduced resources, global health crises, or other factors could materially and adversely affect our ability to consummate an equity or debt financing on favorable terms or at all. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, existing stockholders’ ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect existing stockholders’ rights as common stockholders. 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. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
We historically financed our operations primarily through the issuances of convertible promissory notes and convertible preferred stock, sales of our common stock, and strategic collaborations with other companies. Since our inception, we have devoted substantially all of our resources to raising capital, organizing and staffing our company, business and scientific planning, conducting discovery and research and development activities, establishing, maintaining, and protecting our intellectual property portfolio, developing and progressing our product candidates and preparing for clinical trials, establishing arrangements with third parties for the manufacture of our product candidates and component materials, engaging in collaboration activities, and providing general and administrative support for these operations.
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Critical Accounting Policies and Use of Estimates
Management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these unaudited condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
During the six months ended June 30, 2026, there have been no material changes to our critical accounting policies and estimates as described in the 2025 Annual Report.
Recent Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 1 to our unaudited condensed financial statements included elsewhere in this Quarterly Report.
Emerging Growth Company and Smaller Reporting Company Status
We currently qualify as “emerging growth company” under the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”), which permits us to take advantage of an extended transition period to comply with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of accounting standards that have different effective dates for public and private companies until those standards would otherwise apply to private companies. We have elected to use this extended transition period under the JOBS Act until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates. We could be an emerging growth company until the earliest to occur: (i) the last day of the fiscal year in which we have more than $1.235 billion in annual gross revenue; (ii) the date we qualify as a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, with at least $700.0 million of equity securities held by non-affiliates and we are not eligible to use the requirements for “smaller reporting companies” under the revenue test; (iii) the issuance, in any three-year period, by us of more than $1.0 billion in non-convertible debt securities; or (iv) the last day of the fiscal year ending after the fifth anniversary of our IPO. Even after we no longer qualify as an emerging growth company, we may continue to qualify as a “smaller reporting company,” which would allow us to take advantage of many of the same exemptions from disclosure requirements including reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, if 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.