Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations and the unaudited interim condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q (the "Quarterly Report") should be read in conjunction with the audited financial statements and related notes thereto in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the Securities and Exchange Commission (the "SEC") on March 5, 2026 (the "2025 Form 10-K"). This discussion and analysis and other parts of this Quarterly Report contain forward-looking statements. Our actual results and the timing of selected events could differ materially from those described in or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the sections of this Quarterly Report titled "Special Note Regarding Forward-Looking Statements and Industry Data," and those risk factors described in "Part I, Item 1A, Risk Factors" of our 2025 Form 10-K and in "Part II, Item 1A, Risk Factors" in this Quarterly Report.
We are a clinical-stage biopharmaceutical company pioneering the discovery and development of a new class of RNA-targeting therapeutics with the goal of upregulating gene expression and restoring healthy protein levels to treat a broad range of genetic diseases. Our lead product candidate, CMP-002, has the potential to be the first disease-modifying therapy for the treatment of synaptic Ras GTPase activating protein 1 ("SYNGAP1")-related disorder, or SYNGAP1, a severe developmental and epileptic encephalopathy ("DEE") characterized by seizures, developmental delays, and cognitive impairments. SYNGAP1 is caused by haploinsufficiency of the SYNGAP1 gene, where mutation of one functional gene copy results in a reduction in SYNGAP protein levels of up to 50%. While we believe that it remains underdiagnosed, we estimate that there are approximately 21,000 individuals living with SYNGAP1 in the United States and the five largest European markets. There are no approved disease-modifying therapies for SYNGAP1.
CMP-002 is a novel, intrathecally delivered antisense oligonucleotide ("ASO") designed to target the SYNGAP1 gene at the transcriptional level to increase gene expression, which may increase SYNGAP protein levels in amounts sufficient to yield therapeutic benefit. In preclinical studies, intracerebroventricular injection of CMP-002 restored SYNGAP protein levels to near normal range in haploinsufficient mice carrying a single copy of the human SYNGAP1 gene after a single dose and rescued motor defects and spatial learning defects following two doses. A single dose of CMP-002 also produced a statistically significant improvement in both seizure threshold and severity of chemically induced tonic-clonic seizures in SYNGAP1 haploinsufficient mice, suggesting the potential for therapeutic benefit across both the neurodevelopmental and seizure phenotypes that characterize SYNGAP1-related disorder. In addition, biweekly intrathecal injections of CMP-002 in cynomolgus monkeys were well tolerated and significantly increased SYNGAP protein levels across multiple brain regions clinically relevant to the disease, with dose-linear increases of CMP-002 in disease-relevant brain regions. We have received clearance from Australia's Therapeutic Goods Administration and Argentina's Administración Nacional de Medicamentos, Alimentos y Tecnología Médica to initiate our Phase 1/2 clinical trial of CMP-002 in individuals with SYNGAP1, and we have submitted additional regulatory filings in the European Union and United Kingdom to support broader enrollment across multiple sites. We intend to initiate the Phase 1/2 clinical trial in the fourth quarter of 2026.
Our product development efforts are enabled by our proprietary RAP Platform. We leverage our RAP Platform to identify and characterize regulatory RNAs ("regRNAs"), which play a central role in the regulation of every protein-coding gene by contributing to gene activation and suppression. Our approach is designed to amplify messenger RNA ("mRNA") expression by harnessing the power of regRNAs that form localized complexes with transcription factors and regulate gene expression. Our RAP Platform allows us to rapidly and systematically identify and characterize the active regulatory elements controlling every expressed gene and tens of thousands of druggable enhancer and promoter regRNA sequences that control protein-coding genes. Once a disease-associated target gene is identified, we apply our RAP Platform to identify the controlling regRNA and rapidly generate novel ASO candidates. These ASOs are designed to bind to the identified regRNA and amplify the expression of the target gene in a specific and controllable way.
Our primary therapeutic focus is on diseases of the central nervous system ("CNS"), where there are numerous rare and prevalent haploinsufficient diseases with no approved treatments for which a modest increase in protein expression has the potential to be clinically meaningful. In addition to our SYNGAP1 program, we are advancing discovery programs in other CNS indications. We also intend to leverage strategic discovery partnerships, including our research, collaboration, and license agreement with GlaxoSmithKline, to extend the application of our RAP Platform beyond the CNS and validate our approach to gene upregulation in additional tissues and disease areas.
Since our inception in 2015, we have focused substantially all of our resources primarily on developing our RAP Platform, identifying, developing and progressing our product candidates through preclinical and clinical development,
organizing and staffing our company, conducting research and development ("R&D") activities, establishing and protecting our intellectual property portfolio, and raising capital. To date, we have primarily funded our operations with proceeds from the sale of convertible preferred stock and common stock, including pursuant to an underwritten offering completed in December 2025, a private placement of our common stock and pre-funded warrants (the "Private Placement"), the initial closing of which occurred in September 2025 (the "Initial Closing"), and the second closing of which occurred in August 2026 (the "Second Closing"), and our initial public offering ("IPO"), which closed on October 15, 2024, as well as through revenues from our license and collaboration agreements. Through June 30, 2026, we have received net proceeds of $28.1 million from our December 2025 underwritten offering, $46.7 million from the Initial Closing of the Private Placement, $72.4 million from our IPO and $188.3 million from the sale of our convertible preferred stock prior to our IPO. In addition, through June 30, 2026, we have recognized $24.6 million in research collaboration and license revenue through our development and license agreements. Subsequent to June 30, 2026, we received net proceeds of $46.9 from the Second Closing of the Private Placement. Our ability to generate any product revenue and, in particular, our ability to generate product revenue sufficient to achieve profitability, will depend on the successful development and eventual commercialization of product candidates.
We have incurred significant operating losses and negative cash flows from operations since our inception. Our net losses were $51.9 million and $25.0 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $344.0 million. Substantially all our net losses have resulted from costs incurred in connection with our R&D programs and, to a lesser extent, from general and administrative ("G&A") costs associated with our operations. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and preclinical studies, our other R&D activities and capital expenditures, and the timing and amount of any milestone or royalty payments due under our existing or future license or collaboration agreements. In addition, we incur additional costs associated with operating as a public company, including significant legal, audit, accounting, regulatory and tax-related services associated with maintaining compliance with exchange listing and requirements of the Securities and Exchange Commission ("SEC"), director and officer liability insurance costs, investor and public relations costs, and other expenses that we did not incur as a private company. If we obtain regulatory approval for our product candidates, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing and distribution.
We anticipate that our expenses will increase substantially if and as we:
•finalize preclinical development for CMP-002 and advance into clinical trials;
•advance current and future product candidates through preclinical studies and clinical trials;
•expand the capabilities of our RAP Platform and seek to identify and develop additional product candidates;
•seek marketing approvals for any product candidates that successfully complete clinical trials;
•obtain, expand, maintain, defend and enforce our intellectual property portfolio;
•hire additional clinical, regulatory and scientific personnel;
•contract with third-party manufacturers for preclinical and clinical supply to support any future product candidates we may develop and for commercial supply with respect to any such product candidates that receive regulatory approval;
•ultimately establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval; and
•add operational, legal, compliance, financial and management information systems and personnel to support our research, product development and future commercialization efforts.
Because of the numerous risks and uncertainties associated with the development of therapeutics, we are unable to accurately predict the timing or amount of increased expenses and when, or if, we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations as planned and may be forced to reduce or terminate our operations.
We do not have any products approved for sale and have not generated any revenue from product sales. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our current or any future product candidates, which we expect will take a number of years or may never occur. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through equity offerings, debt financings, or other capital sources, including current and potential future collaborations, license agreements, and other similar arrangements. However, we may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements or arrangements as, and when needed, we may delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise develop and market ourselves, or even cease operations.
As of June 30, 2026, we had cash and cash equivalents of $86.4 million. Based on our current operating plan, we estimate that our cash and cash equivalents as of June 30, 2026, together with the net proceeds of $46.9 million received from the Second Closing under the Purchase Agreement in August 2026, will be sufficient to fund our operating expenses and capital expenditure requirements through the end of 2028. However, we have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we currently expect. See the sections titled "-Liquidity and Capital Resources" and "Risk Factors-Risks Related to our Financial Position and Need for Additional Capital" included in our 2025 Form 10-K.
We do not own or operate and currently have no plans to establish any manufacturing facilities. We rely, and expect to continue to rely, on third parties for preclinical and clinical supply as well as commercial supply if we obtain marketing approval. In addition, we rely on third parties to package, label, store, and distribute our clinical supply and we intend to rely on third parties to conduct the same activities for our commercial products if we obtain regulatory approval. We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment, and personnel while also enabling us to focus our expertise and resources on the development of product candidates and continued enhancement of our RAP Platform.
Results of Operations
Comparison of the Three Months Ended June 30, 2026 and 2025
The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2026
|
|
2025
|
|
Change ($)
|
|
Revenue
|
|
|
|
|
|
|
Research and collaboration revenue
|
$
|
1,779
|
|
|
$
|
1,497
|
|
|
$
|
282
|
|
|
Operating expenses:
|
|
|
|
|
|
|
Research and development
|
10,817
|
|
|
10,343
|
|
|
474
|
|
|
General and administrative
|
4,342
|
|
|
4,182
|
|
|
160
|
|
|
Total operating expenses
|
15,159
|
|
|
14,525
|
|
|
634
|
|
|
Loss from operations
|
(13,380)
|
|
|
(13,028)
|
|
|
(352)
|
|
|
Other (expense) income, net:
|
|
|
|
|
|
|
Interest income
|
807
|
|
|
453
|
|
|
354
|
|
|
Change in fair value of derivative tranche liability
|
(20,930)
|
|
|
-
|
|
|
(20,930)
|
|
|
Other expense
|
(27)
|
|
|
(12)
|
|
|
(15)
|
|
|
Total other (expense) income, net
|
(20,150)
|
|
|
441
|
|
|
(20,591)
|
|
|
Net loss
|
$
|
(33,530)
|
|
|
$
|
(12,587)
|
|
|
$
|
(20,943)
|
|
Research and Collaboration Revenue
We recognized $1.8 million in research and collaboration revenue during the three months ended June 30, 2026, compared to $1.5 million during the three months ended June 30, 2025. Research and collaboration revenue recognized in the three months ended June 30, 2026 related to our Research, Collaboration and License Agreement with
GlaxoSmithKline Intellectual Property (No. 3) Limited ("GSK"). Research and collaboration revenue recognized in the three months ended June 30, 2025 included $0.9 million related to our Collaboration and License Agreement with BioMarin and a $0.6 million milestone payment earned under the Fulcrum Agreement.
Research and Development Expenses
The following table summarizes our R&D expenses for the three months ended June 30, 2026 and 2025 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2026
|
|
2025
|
|
Change ($)
|
|
Clinical and preclinical expenses
|
$
|
5,069
|
|
|
$
|
4,710
|
|
|
$
|
359
|
|
|
Personnel-related expenses
|
3,803
|
|
|
3,325
|
|
|
478
|
|
|
Facilities-related and overhead expense
|
1,428
|
|
|
1,502
|
|
|
(74)
|
|
|
Professional and consulting fees
|
340
|
|
|
559
|
|
|
(219)
|
|
|
Other expenses
|
177
|
|
|
247
|
|
|
(70)
|
|
|
Total R&D expenses
|
$
|
10,817
|
|
|
$
|
10,343
|
|
|
$
|
474
|
|
R&D expenses were $10.8 million for the three months ended June 30, 2026, compared to $10.3 million for the three months ended June 30, 2025. The increase of $0.5 million was primarily driven by higher personnel-related costs of $0.5 million due to increased stock-based compensation expense and an increase of $0.4 million in clinical and preclinical costs as we continue to advance CMP-002, including entering into contractual obligations with a contract research organization for services related to our planned Phase 1/2 clinical trial. These increases were partially offset by decreases of $0.2 million in professional and consulting fees and $0.1 million in facilities-related and overhead expense.
General and Administrative Expenses
The following table summarizes our G&A expenses for the three months ended June 30, 2026 and 2025 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2026
|
|
2025
|
|
Change ($)
|
|
Personnel-related expenses
|
$
|
2,407
|
|
|
$
|
2,268
|
|
|
$
|
139
|
|
|
Professional and consulting fees
|
1,052
|
|
|
1,025
|
|
|
27
|
|
|
Facilities-related and overhead expense
|
329
|
|
|
520
|
|
|
(191)
|
|
|
Other expenses
|
554
|
|
|
369
|
|
|
185
|
|
|
Total G&A expenses
|
$
|
4,342
|
|
|
$
|
4,182
|
|
|
$
|
160
|
|
G&A expenses were $4.3 million for the three months ended June 30, 2026, compared to $4.2 million for the three months ended June 30, 2025. The increase of $0.2 million was primarily driven by an increase in other expenses of $0.2 million, primarily related to travel expenses, and an increase of $0.1 million in personnel-related costs due to increased stock-based compensation expense. These increases were partially offset by a decrease of $0.2 million in facilities and overhead expenses resulting from the rent abatement period starting in October 2025 associated with the December 2025 lease modification.
Other (Expense) Income, Net
Other (expense) income, net for the three months ended June 30, 2026 was a $20.2 million expense, compared to $0.4 million of income for the three months ended June 30, 2025. The change was primarily due to a $20.9 million non-cash expense for the change in fair value of our derivative tranche liability associated with the Second Closing of the Private Placement. The derivative tranche liability was subsequently settled in connection with the Second Closing, which occurred on August 3, 2026. This expense was partially offset by a $0.4 million increase in interest income due to higher average invested cash balances during the three months ended June 30, 2026.
Comparison of the Six Months Ended June 30, 2026 and 2025
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2026
|
|
2025
|
|
Change ($)
|
|
Revenue
|
|
|
|
|
|
|
Research and collaboration revenue
|
$
|
3,073
|
|
|
$
|
2,355
|
|
|
$
|
718
|
|
|
Operating expenses:
|
|
|
|
|
|
|
Research and development
|
20,977
|
|
|
20,489
|
|
|
488
|
|
|
General and administrative
|
8,547
|
|
|
7,994
|
|
|
553
|
|
|
Total operating expenses
|
29,524
|
|
|
28,483
|
|
|
1,041
|
|
|
Loss from operations
|
(26,451)
|
|
|
(26,128)
|
|
|
(323)
|
|
|
Other (expense) income, net:
|
|
|
|
|
|
|
Interest income
|
1,717
|
|
|
1,041
|
|
|
676
|
|
|
Change in fair value of derivative tranche liability
|
(27,118)
|
|
|
-
|
|
|
(27,118)
|
|
|
Other (expense) income
|
(9)
|
|
|
67
|
|
|
(76)
|
|
|
Total other (expense) income, net
|
(25,410)
|
|
|
1,108
|
|
|
(26,518)
|
|
|
Net loss
|
$
|
(51,861)
|
|
|
$
|
(25,020)
|
|
|
$
|
(26,841)
|
|
Research and Collaboration Revenue
We recognized $3.1 million in research and collaboration revenue during the six months ended June 30, 2026, compared to $2.4 million during the six months ended June 30, 2025. Research and collaboration revenue recognized in the six months ended June 30, 2026 primarily related to our Research, Collaboration and License Agreement with GSK. Research and collaboration revenue recognized in the six months ended June 30, 2025 included $1.8 million related to our Collaboration and License Agreement with BioMarin and a $0.6 million milestone payment earned under the Fulcrum Agreement.
Research and Development Expenses
The following table summarizes our R&D expenses for the six months ended June 30, 2026 and 2025 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2026
|
|
2025
|
|
Change ($)
|
|
Clinical and preclinical expenses
|
$
|
9,700
|
|
|
$
|
9,189
|
|
|
$
|
511
|
|
|
Personnel-related expenses
|
7,270
|
|
|
6,492
|
|
|
778
|
|
|
Facilities-related and overhead expense
|
2,862
|
|
|
2,948
|
|
|
(86)
|
|
|
Professional and consulting fees
|
724
|
|
|
1,393
|
|
|
(669)
|
|
|
Other expenses
|
421
|
|
|
467
|
|
|
(46)
|
|
|
Total R&D expenses
|
$
|
20,977
|
|
|
$
|
20,489
|
|
|
$
|
488
|
|
R&D expenses were $21.0 million for the six months ended June 30, 2026, compared to $20.5 million for the six months ended June 30, 2025. The $0.5 million increase was primarily driven by higher personnel-related costs of $0.8 million due to increased stock-based compensation expense and an increase of $0.5 million in clinical and preclinical costs as we continue to advance CMP-002, including entering into contractual obligations with a contract research organization for services related to our planned Phase 1/2 clinical trial. These increases were partially offset by decreases of $0.7 million in professional and consulting fees, primarily due to lower outsourced clinical operations costs following the hiring of internal clinical operations personnel, and a decrease of $0.1 million in facilities-related and overhead expense.
General and Administrative Expenses
The following table summarizes our G&A expenses for the six months ended June 30, 2026 and 2025 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2026
|
|
2025
|
|
Change ($)
|
|
Personnel-related expenses
|
4,815
|
|
|
4,287
|
|
|
$
|
528
|
|
|
Professional and consulting fees
|
2,139
|
|
|
1,793
|
|
|
346
|
|
|
Facilities-related and overhead expense
|
688
|
|
|
1,050
|
|
|
(362)
|
|
|
Other expenses
|
905
|
|
|
864
|
|
|
41
|
|
|
Total G&A expenses
|
$
|
8,547
|
|
|
$
|
7,994
|
|
|
$
|
553
|
|
G&A expenses were $8.5 million for the six months ended June 30, 2026, compared to $8.0 million for the six months ended June 30, 2025. The increase of $0.6 million was primarily driven by personnel-related costs of $0.5 million due to increased stock-based compensation expense and an increase of $0.3 million in professional and consulting fees. These increases were partially offset by a decrease of $0.4 million in facilities and overhead expenses due to the rent abatement period associated with the December 2025 lease modification starting in October 2025.
Other (Expense) Income, Net
Other (expense) income, net for the six months ended June 30, 2026 was a $25.4 million expense, compared to $1.1 million income for the six months ended June 30, 2025. The change was primarily due to a $27.1 million non-cash expense for the change in fair value of our derivative tranche liability associated with the Second Closing of our Private Placement. The derivative tranche liability was subsequently settled in connection with the Second Closing, which occurred on August 3, 2026. This expense was partially offset by a $0.7 million increase in interest income due to higher average invested cash balances during the six months ended June 30, 2026.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from operations. We expect to incur significant expenses and operating losses in the foreseeable future as we advance the development of product candidates. Through June 30, 2026, we have primarily funded our operations with proceeds from the sale of our equity securities and revenues from our license and collaboration agreements.
In November 2025, we filed a shelf registration statement on Form S-3 (the "Shelf Registration Statement"). Pursuant to the Shelf Registration Statement, we may offer and sell securities having an aggregate public offering price of up to $300.0 million.
In connection with the filing of the Shelf Registration Statement, we also entered into a sales agreement (the "Sales Agreement") with Leerink Partners LLC, as sales agent, pursuant to which we may issue and sell shares of our common stock for a maximum aggregate offering price of up to $100.0 million, which is included in the $300.0 million of securities that may be offered pursuant to the Shelf Registration Statement. Pursuant to the Sales Agreement, we will pay the sales agent a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of our common stock. We are not obligated to make any sales of shares of our common stock under the Sales Agreement. During the three and six months ended June 30, 2026 and the year ended December 31, 2025, we did not issue any shares of our common stock under the Sales Agreement.
As of June 30, 2026, we had cash and cash equivalents of $86.4 million. Based on our current operating plan, we estimate that our cash and cash equivalents as of June 30, 2026, together with the net proceeds of $46.9 million received from the Second Closing under the Purchase Agreement in August 2026, will be sufficient to fund our operating expenses and capital expenditure requirements through the end of 2028. However, we have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we currently expect. Our future viability is dependent on our ability to generate cash from our operating activities or to raise additional capital to finance our
operations. There is no assurance that we will succeed in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all.
Future Funding Requirements
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we continue our development of, seek regulatory approval for, and potentially commercialize our product candidates and seek to discover and develop additional product candidates, conduct our ongoing and planned clinical trials and preclinical studies, continue our R&D activities, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company.
The timing and amount of our future funding requirements will depend on many factors, including:
•the initiation, type, number, scope, progress, expansions, results, costs and timing of preclinical studies and clinical trials of our product candidates and any future product candidates we may choose to pursue, including the costs of modification to clinical development plans based on feedback that we may receive from regulatory authorities and any third-party products used as combination agents in our clinical trials;
•the costs and timing of manufacturing for our product candidates, including commercial manufacturing at sufficient scale, if any product candidate is approved;
•timing and outcome of regulatory meetings and reviews of our product candidates or any future product candidates, including requirements of regulatory authorities in any additional jurisdictions in which we may seek approval and any future product candidates;
•the costs of obtaining, maintaining, enforcing and protecting our patents and other intellectual property and proprietary rights;
•our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal control over financial reporting;
•the costs associated with hiring additional personnel and consultants as our clinical and preclinical activities increase;
•the timing and payment of milestone, royalty or other payments we must make or may receive pursuant to our existing and potential future license or collaboration agreements with third parties;
•the costs and timing of establishing or securing sales and marketing capabilities if our product candidates or any future product candidate is approved;
•our ability to achieve sufficient market acceptance, coverage, and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;
•patients' ability and willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors;
•the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; and
•costs associated with any products or technologies that we may in-license or acquire.
Our operating plans and other demands for our cash resources may change because of many factors currently unknown to us, and we may need to seek additional funds sooner than planned.
We have no other committed sources of capital. Until such time, if ever, we can generate substantial product revenues, we expect to finance our operations through the sale of equity securities, debt financings, working capital lines of credit, strategic alliances and/or license arrangements, grant funding, interest income earned on invested cash balances or a combination of two or more of these sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms or at all. To the extent we raise additional capital through the sale of equity
or convertible debt securities, investors' ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of a common stockholder. 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, engaging in acquisition, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments or declaring dividends. If we raise additional funds through collaborations or license agreements 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 when needed, we may be required to delay, limit, reduce or terminate our 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, or even cease operations.
Contractual and Other Obligations
As of June 30, 2026, other than those disclosed within Notes 4, 5, and 6 to our condensed consolidated financial statements, there have been no material changes to our contractual obligations and commitments from those described under "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in our 2025 Form 10-K.
Cash Flows
For the Six Months Ended June 30, 2026 and 2025
The following table provides information regarding our cash flows for the six months ended June 30, 2026 and 2025 (in thousands):
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|
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2026
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2025
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Net cash used in operating activities
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$
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(23,667)
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$
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(24,629)
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Net cash used in investing activities
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(129)
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(279)
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Net cash provided by (used in) financing activities
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61
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(79)
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Net change in cash, cash equivalents, and restricted cash
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$
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(23,735)
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$
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(24,987)
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Operating Activities
During the six months ended June 30, 2026, operating activities used $23.7 million of cash, primarily resulting from our net loss of $51.9 million and the timing of working capital fluctuations of $3.5 million, partially offset by non-cash charges of $31.7 million, including stock-based compensation expense, loss from the change in fair value of our derivative tranche liability, non-cash operating lease expense, and depreciation and amortization.
During the six months ended June 30, 2025, operating activities used $24.6 million of cash, primarily resulting from our net loss of $25.0 million and the timing of working capital fluctuations of $3.3 million, partially offset by non-cash charges of $3.7 million, including stock-based compensation expense, non-cash operating lease expense, and depreciation and amortization.
In each of the six months ended June 30, 2026 and 2025, cash used in operations was primarily related to clinical and preclinical efforts, compensation and benefits for our employees, consulting and other professional fees, and rent and overhead for our Cambridge and Boulder leases.
Investing Activities
During the six months ended June 30, 2026 and 2025, net cash used in investing activities was $0.1 million and $0.3 million, respectively, due to purchases of property and equipment.
Financing Activities
During the six months ended June 30, 2026, net cash provided by financing activities was $0.1 million, consisting of proceeds from the exercise of stock options and issuance of common stock under the 2024 Employee Stock Purchase Plan.
During the six months ended June 30, 2025, net cash used in financing activities was $0.1 million, consisting of principal payments on finance leases.
Critical Accounting Policies and Significant Judgments and Estimates
There have been no significant changes to our critical accounting estimates in the preparation of our condensed consolidated financial statements during the six months ended June 30, 2026 compared to those disclosed in our 2025 Form 10-K.
Recently Issued Accounting Standards
See Note 1 to our condensed consolidated financial statements included elsewhere in this Quarterly Report for more information.
Emerging Growth Company and Smaller Reporting Company Status
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"), and we may remain an emerging growth company until December 31, 2029 or until such earlier time that we are no longer an emerging growth company. For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved and an exemption from compliance with the requirements regarding the communication of critical audit matters in the auditor's report on financial statements.
In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. We have elected to avail ourselves of this extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to "opt out" of such extended transition period or (ii) no longer qualify as an emerging growth company. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies. As a result of this election, our financial statements may not be comparable to those of companies that are not emerging growth companies.
We will remain an emerging growth company until the earliest to occur of: (i) the last day of the fiscal year in which we have at least $1.235 billion in annual revenue; (ii) the last day of the fiscal year in which we are deemed to be a "large accelerated filer," as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt securities during the prior three-year period; and (iv) December 31, 2029.
We are also a "smaller reporting company," meaning that the market value of our shares held by non-affiliates is less than $700.0 million and our annual revenue was less than $100.0 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either: (i) the market value of our shares held by non-affiliates is less than $250.0 million; or (ii) our annual revenue was less than $100.0 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.