# Corvus Pharmaceuticals, Inc. (CRVS)

Informational only - not investment advice.

CIK: 0001626971
SIC: 2834 Pharmaceutical Preparations
SIC breadcrumb: [Manufacturing](/division/D/) > [Chemicals And Allied Products](/major-group/28/) > [SIC 2834 Pharmaceutical Preparations](/industry/2834/)
Latest 10-K filed: 2026-03-12
SEC page: https://www.sec.gov/edgar/browse/?CIK=1626971
Filing source: https://www.sec.gov/Archives/edgar/data/1626971/000110465926027047/crvs-20251231x10k.htm

## Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
| --- | ---: | --- | ---: | --- |
| Net income | -15283000 | USD | 2025 | 2026-03-12 |
| Assets | 71119000 | USD | 2025 | 2026-03-12 |

## Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-03-12. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001626971.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

| Metric | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Net income |  | -36,375,000 | -55,663,000 | -46,939,000 | -46,672,000 | -5,995,000 | -43,241,000 | -41,307,000 | -27,029,000 | -62,293,000 | -15,283,000 |
| Operating income |  | -36,976,000 | -56,524,000 | -49,222,000 | -48,854,000 | -43,760,000 | -38,630,000 | -32,565,000 | -23,407,000 | -27,548,000 | -42,971,000 |
| Diluted EPS |  |  |  |  | -1.59 | -0.20 | -1.03 | -0.89 | -0.56 | -1.02 | -0.53 |
| Operating cash flow |  | -27,857,000 | -46,212,000 | -40,988,000 | -37,321,000 | -34,778,000 | -36,715,000 | -27,023,000 | -23,935,000 | -25,424,000 | -32,797,000 |
| Capital expenditures | 1,747,000 | 2,199,000 | 266,000 | 355,000 | 25,000 | 76,000 | 5,000 | 269,000 | 34,000 |  | 174,000 |
| Assets |  | 140,150,000 | 94,775,000 | 118,232,000 | 83,646,000 | 85,529,000 | 109,455,000 | 68,240,000 | 45,553,000 | 68,907,000 | 71,119,000 |
| Liabilities |  | 7,349,000 | 9,940,000 | 7,896,000 | 12,535,000 | 13,381,000 | 12,293,000 | 12,125,000 | 6,869,000 | 36,339,000 | 9,914,000 |
| Stockholders' equity |  | 132,801,000 | 84,835,000 | 110,336,000 | 71,111,000 | 72,148,000 | 97,162,000 | 56,115,000 | 38,684,000 | 32,568,000 | 61,205,000 |
| Cash and cash equivalents |  | 5,050,000 | 45,106,000 | 39,196,000 | 5,154,000 | 16,455,000 | 63,458,000 | 13,159,000 | 12,620,000 | 8,740,000 | 4,576,000 |
| Free cash flow |  | -30,056,000 | -46,478,000 | -41,343,000 | -37,346,000 | -34,854,000 | -36,720,000 | -27,292,000 | -23,969,000 |  | -32,971,000 |

### Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

| Metric | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Return on equity |  | -27.39% | -65.61% | -42.54% | -65.63% | -8.31% | -44.50% | -73.61% | -69.87% | -191.27% | -24.97% |
| Return on assets |  | -25.95% | -58.73% | -39.70% | -55.80% | -7.01% | -39.51% | -60.53% | -59.34% | -90.40% | -21.49% |
| Liabilities / equity |  | 0.06 | 0.12 | 0.07 | 0.18 | 0.19 | 0.13 | 0.22 | 0.18 | 1.12 | 0.16 |
| Current ratio |  | 22.89 | 10.17 | 16.45 | 7.76 | 3.73 | 7.36 | 4.06 | 4.07 | 1.54 | 6.21 |

## Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-05-07. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001626971.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

| Quarter | End date | Revenue | Net income | Diluted EPS | Method |
| --- | --- | ---: | ---: | ---: | --- |
| 2022-Q2 | 2022-06-30 |  |  | -0.18 | reported discrete quarter |
| 2022-Q3 | 2022-09-30 |  |  | -0.26 | reported discrete quarter |
| 2023-Q1 | 2023-03-31 |  |  | -0.17 | reported discrete quarter |
| 2023-Q2 | 2023-03-31 |  | -7,873,000 |  | reported discrete quarter |
| 2023-Q2 | 2023-06-30 |  |  | -0.14 | reported discrete quarter |
| 2023-Q3 | 2023-06-30 |  | -6,503,000 |  | reported discrete quarter |
| 2023-Q3 | 2023-09-30 |  |  | -0.12 | reported discrete quarter |
| 2023-Q4 | 2023-12-31 |  | -6,653,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2024-Q1 | 2024-03-31 |  | -5,701,000 | -0.12 | reported discrete quarter |
| 2024-Q2 | 2024-03-31 |  | -5,701,000 |  | reported discrete quarter |
| 2024-Q2 | 2024-06-30 |  |  | -0.07 | reported discrete quarter |
| 2024-Q3 | 2024-06-30 |  | -4,262,000 |  | reported discrete quarter |
| 2024-Q3 | 2024-09-30 |  |  | -0.60 | reported discrete quarter |
| 2024-Q4 | 2024-12-31 |  | -12,113,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2025-Q1 | 2025-03-31 |  | 15,193,000 | -0.13 | reported discrete quarter |
| 2025-Q2 | 2025-03-31 |  | 15,193,000 |  | reported discrete quarter |
| 2025-Q2 | 2025-06-30 |  |  | -0.10 | reported discrete quarter |
| 2025-Q3 | 2025-06-30 |  | -7,998,000 |  | reported discrete quarter |
| 2025-Q3 | 2025-09-30 |  |  | -0.12 | reported discrete quarter |
| 2025-Q4 | 2025-12-31 |  | -12,321,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2026-Q1 | 2026-03-31 |  | -13,692,000 | -0.15 | reported discrete quarter |

## Macro Cross-References
- [CPIAUCSL](/indicator/CPIAUCSL/): Consumer Price Index for All Urban Consumers: All Items in U.S. City Average
- [UNRATE](/indicator/UNRATE/): Unemployment Rate
- [FEDFUNDS](/indicator/FEDFUNDS/): Federal Funds Effective Rate
- [CES0500000003](/indicator/CES0500000003/): Average Hourly Earnings of All Employees, Total Private
- [DFEDTARU](/indicator/DFEDTARU/): Federal Funds Target Range - Upper Limit
- [DFEDTARL](/indicator/DFEDTARL/): Federal Funds Target Range - Lower Limit
- [DGS3MO](/indicator/DGS3MO/): Market Yield on U.S. Treasury Securities at 3-Month Constant Maturity
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- [DGS10](/indicator/DGS10/): Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
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- [T10Y2Y](/indicator/T10Y2Y/): 10-Year Treasury Constant Maturity Minus 2-Year Treasury Constant Maturity
- [CPILFESL](/indicator/CPILFESL/): Consumer Price Index for All Urban Consumers: All Items Less Food and Energy
- [CPIUFDSL](/indicator/CPIUFDSL/): Consumer Price Index for All Urban Consumers: Food
- [CPIENGSL](/indicator/CPIENGSL/): Consumer Price Index for All Urban Consumers: Energy
- [CUSR0000SAH1](/indicator/CUSR0000SAH1/): Consumer Price Index for All Urban Consumers: Shelter
- [PCEPI](/indicator/PCEPI/): Personal Consumption Expenditures: Chain-type Price Index
- [PCEPILFE](/indicator/PCEPILFE/): Personal Consumption Expenditures Excluding Food and Energy: Chain-type Price Index
- [PPIACO](/indicator/PPIACO/): Producer Price Index by Commodity: All Commodities
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- [U6RATE](/indicator/U6RATE/): Total Unemployed, Plus All Marginally Attached Workers Plus Total Employed Part Time for Economic Reasons
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- [JTSQUR](/indicator/JTSQUR/): Quits: Total Nonfarm
- [GDPC1](/indicator/GDPC1/): Real Gross Domestic Product
- [A191RL1Q225SBEA](/indicator/A191RL1Q225SBEA/): Real Gross Domestic Product: Percent Change from Preceding Period
- [INDPRO](/indicator/INDPRO/): Industrial Production: Total Index
- [TCU](/indicator/TCU/): Capacity Utilization: Total Index
- [HOUST](/indicator/HOUST/): New Privately-Owned Housing Units Started: Total Units
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- [RSAFS](/indicator/RSAFS/): Advance Retail Sales: Retail Trade
- [PCE](/indicator/PCE/): Personal Consumption Expenditures
- [DSPIC96](/indicator/DSPIC96/): Real Disposable Personal Income
- [PSAVERT](/indicator/PSAVERT/): Personal Saving Rate
- [M2SL](/indicator/M2SL/): M2
- [BOPGSTB](/indicator/BOPGSTB/): U.S. International Trade in Goods and Services: Balance
- [MSPUS](/indicator/MSPUS/): Median Sales Price of Houses Sold for the United States
- [HSN1F](/indicator/HSN1F/): New One Family Houses Sold: United States
- [RHORUSQ156N](/indicator/RHORUSQ156N/): Homeownership Rate in the United States
- [TTLCONS](/indicator/TTLCONS/): Total Construction Spending: Total Construction in the United States
- [RRVRUSQ156N](/indicator/RRVRUSQ156N/): Rental Vacancy Rate in the United States
- [TOTALSL](/indicator/TOTALSL/): Total Consumer Credit Owned and Securitized
- [REVOLSL](/indicator/REVOLSL/): Revolving Consumer Credit Owned and Securitized
- [DRCCLACBS](/indicator/DRCCLACBS/): Delinquency Rate on Credit Card Loans, All Commercial Banks
- [GDP](/indicator/GDP/): Gross Domestic Product
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- [GCE](/indicator/GCE/): Government Consumption Expenditures and Gross Investment
- [PCEC](/indicator/PCEC/): Personal Consumption Expenditures
- [NETEXP](/indicator/NETEXP/): Net Exports of Goods and Services
- [GFDEBTN](/indicator/GFDEBTN/): Federal Debt: Total Public Debt
- [GFDEGDQ188S](/indicator/GFDEGDQ188S/): Federal Debt: Total Public Debt as Percent of Gross Domestic Product
- [FYFSD](/indicator/FYFSD/): Federal Surplus or Deficit
- [FGRECPT](/indicator/FGRECPT/): Federal Government Current Receipts
- [FGEXPND](/indicator/FGEXPND/): Federal Government: Current Expenditures
- [MANEMP](/indicator/MANEMP/): All Employees, Manufacturing
- [USCONS](/indicator/USCONS/): All Employees, Construction
- [USTRADE](/indicator/USTRADE/): All Employees, Retail Trade
- [USFIRE](/indicator/USFIRE/): All Employees, Financial Activities
- [USGOVT](/indicator/USGOVT/): All Employees, Government
- [AWHAETP](/indicator/AWHAETP/): Average Weekly Hours of All Employees, Total Private
- [DGORDER](/indicator/DGORDER/): Manufacturers' New Orders: Durable Goods
- [NEWORDER](/indicator/NEWORDER/): Manufacturers' New Orders: Nondefense Capital Goods Excluding Aircraft
- [BUSINV](/indicator/BUSINV/): Total Business Inventories
- [EXPGS](/indicator/EXPGS/): Exports of Goods and Services
- [IMPGS](/indicator/IMPGS/): Imports of Goods and Services
- [IR](/indicator/IR/): Import Price Index (End Use): All Commodities
- [PPIFIS](/indicator/PPIFIS/): Producer Price Index by Commodity: Final Demand

## Latest quarter (10-Q)

Latest 10-Q source: https://www.sec.gov/Archives/edgar/data/1626971/000110465926057100/crvs-20260331x10q.htm

Extracted structurally from real Item 2 body heading to real Item 3/4 boundary.
Confidence: high
Filing date: 2026-05-07
Report date: 2026-03-31

Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations

​

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited condensed consolidated financial statements and notes for the year ended December 31, 2025, included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 12, 2026.

​

This discussion and other parts of this report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this report entitled “Risk Factors.” Except as may be required by law, we assume no obligation to update these forward-looking statements or the reasons that results could differ from these forward-looking statements.

​

Overview

​

We are a clinical stage biopharmaceutical company developing product candidates that precisely target proteins that are critical to immune cell maturation and function. We believe our proprietary product candidates have broad potential to address immune mediated diseases, inflammatory diseases and cancers.

Our lead product candidate, soquelitinib (formerly CPI-818), is designed to bind specifically to a protein, interleukin 2 inducible T cell kinase (“ITK”), involved in T cell activation, T cell receptor signaling and T cell differentiation and function. Based on the proposed mechanism of action, we believe soquelitinib has the potential to be utilized to inhibit the production of a number of inflammatory cytokines involved in diseases such as atopic dermatitis, hidradenitis suppurativa, asthma, psoriasis and fibrotic diseases. In preclinical studies, Soquelitinib has affected T cell differentiation leading to enhanced function of T cells involved in tumor cell eradication.

Since the immune cells targeted by our product candidates play a role in many diseases, our strategy is to leverage our research and development capabilities by evaluating our product candidates in clinical trials where there is an understanding of the role of specific T cells in the target indication and where we believe such product candidates have the broadest potential. We believe this strategy has enabled us to move rapidly from preclinical to clinical trials in diverse disease areas, each with large unmet needs. We are enrolling patients in a potentially registrational Phase 3 clinical trial of soquelitinib for relapsed peripheral T cell lymphomas. Soquelitinib is also being evaluated in a randomized, placebo-controlled Phase 2 trial in patients with atopic dermatitis. We have two additional product candidates which are in clinical development for the treatment of various solid tumors, also based on modulation of immune function.

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Product Candidate Pipeline

Our product candidate pipeline and anticipated milestones include the following:

​

(1)

A Phase 1b/2 clinical trial in atopic dermatitis is being conducted by Angel Pharmaceuticals, the Company’s partner in China.

(2)

The Company did not conduct Phase 1 studies for these specific indications, but is planning to initiate Phase 2 studies for these indications based on the Phase 1 Atopic Dermatitis study.

​

Soquelitinib (CPI-818), ITK Inhibitor. Soquelitinib is an investigational selective, orally bioavailable, covalent inhibitor of ITK. ITK, an enzyme that functions in T cell signaling and differentiation, is expressed predominantly in T cells, which are lymphocytes that play a vital role in immune responses. T cell lymphomas are malignancies of T cells that proliferate and spread throughout the body. These lymphomas often have uncontrolled tonic signaling through the T cell receptor pathway, which involves ITK. Inhibition of ITK with soquelitinib could result in blockade of this signaling pathway and control the growth of the malignancy. In addition, one of the key survival mechanisms of both lymphomas and solid tumors is believed to be the reprogramming of normal T cells to create an environment in the tissues that inhibits an anti-tumor immune response and favors tumor growth. We believe highly selective inhibitors of this enzyme will facilitate induction of normal T cell anti-tumor immunity and may be useful in the treatment of solid tumors as well as lymphomas. A normal functioning immune system maintains balance between inflammation, needed to fight infection or eliminate noxious agents, and suppression of inflammation necessary when the inflammatory signals are eliminated. This balance is restored through the action of T regulatory cells, which dampen inflammatory responses. ITK plays a vital role in the function of these regulatory T cells where it acts to modulate immune responses.

In ITK genetic knockout mice, which completely lack expression of ITK, T cells exhibit defects in T helper cell differentiation and cytokine secretion but retain the ability to differentiate into cytotoxic T cells that secrete IL-2 and interferon gamma (“IFNg”), which are the cells responsible for tumor rejection. We believe that skewing T helper cell differentiation to favor cytotoxic T cells, known as Th1 skewing, may be beneficial in treating T cell lymphomas and many other types of cancer. Mice with genetic knock-out of ITK also demonstrate a reduction in Th2 and Th17 cells, which produce the cytokines that are often responsible for autoimmunity and allergy such as interleukin (Il) Il-4, Il-5, Il-13, Il-17 and many others.

We have designed and developed soquelitinib to covalently target the cysteine amino acid residue at position 442 in the ITK protein. We believe this irreversible targeting of ITK has the potential to provide a potent, selective and prolonged duration of activity without the need for high systemic exposures and thereby improve the therapeutic window. This approach was previously used by our cofounders to generate ibrutinib. Selective inhibition of ITK can block the production and function of Th2 and Th17 helper T cells, potentially leading to a biasing toward the differentiation of naïve T cells into Th1 helper T cells. Th1 cells lead to the generation of killer T cells that can eliminate tumor cells or viral infected cells. Th1 cells produce interferon gamma and tumor necrosis factor that are cytokines known to destroy cancer cells. We believe, based on our preclinical and Phase 1/1b data from our T cell lymphoma

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clinical trial, that soquelitinib has the potential to reprogram normal immune responses that also could be beneficial for the treatment of certain autoimmune, inflammatory and allergic diseases. Overactive Th2 and Th17 cells are known to play a role in autoimmune, inflammatory and allergic diseases, which can potentially be ameliorated by selective ITK inhibition by blocking Th2 and Th17 function and their production of inflammatory cytokines such as IL4, IL5, IL13, IL17 and others.

In December 2024, we and our academic collaborators published results describing the chemistry, enzymology and preclinical anti-tumor activity of soquelitinib in the journal npj Drug Discovery. Key results from the publication include that soquelitinib:

●

Selectively bound to and inhibited ITK function while sparing other closely related kinases, including resting lymphocyte kinase.

●

Inhibited Th2 T cell function and the production of various Th2 cytokines leading to Th1 skewing and production of interferon gamma and tumor necrosis factor, which are important cytokines in tumor rejection. Th2 cytokines have been previously implicated in promoting tumor growth and are also involved in autoimmune and allergic diseases.

●

Activated cytotoxic killer cells and increases infiltration of these cells into tumors.

●

Reduced and reversed T cell exhaustion resulting in a more potent and prolonged immune response. T cell exhaustion is often a major reason for resistance to immune checkpoint therapy.

●

Led to in vivo anti-tumor activity in several mouse tumor models, including colon, renal, melanoma, B cell and T cell tumor.

Soquelitinib for treatment of T cell lymphomas.

Soquelitinib is currently being studied both in cancer and in immune mediated diseases. A Phase 1/1b clinical trial was conducted in patients with relapsed T cell lymphomas that was designed to select the optimal dose of soquelitinib and evaluate its safety, pharmacokinetics (“PK”), target occupancy, immunologic effects, biomarkers and efficacy. The study is now complete, however, some of the patients remain on therapy and are continuing to receive follow-up monitoring. The trial enrolled 75 patients (27 in the dose escalation portion and 48 in dose expansion portion) with various T cell lymphomas, including peripheral T cell lymphoma (“PTCL”), T follicular helper cell lymphoma, natural killer cell T cell lymphoma, cutaneous T cell lymphoma, anaplastic large cell lymphoma and adult T cell lymphoma/leukemia. The median number of prior therapies was three (range 1-18), with only 31% achieving an objective response to their most recent prior therapy. In the dose escalation portion, patients received a twice-daily dose of soquelitinib of 100 mg, 200 mg, 400 mg or 600 mg, and the 200 mg twice-daily dose (“200 mg BID”) was selected for the dose expansion portion based on biomarker studies indicating that doses of 200 mg or higher achieved complete occupancy of the ITK target with the drug.

Final data from the Phase 1/1b clinical trial were presented at the American Society of Hematology Annual Meeting (“ASH”) in December 2025. Key highlights from the data supporting the ongoing registration Phase 3 trial in relapsed/refractory PTCL include:

●

No dose limiting toxicities or significant adverse events were observed in any patients in all dose cohorts up to 600 mg twice-daily, including no myelosuppression or immunosuppression;

●

Objective and durable tumor responses were seen in the 200 mg twice-daily cohort (N=36) with 6 patients experiencing complete responses;

●

In the 200 mg twice-daily cohort, it was determined that patients with between ≥1 and ≤3 prior therapies and an adequate peripheral blood lymphocyte count (N=24) were most likely to be responders to therapy.

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In this patient population:

o

Objective responses were seen in 9 of 24 patients including 6 complete responses and 3 partial responses;

o

Median progression free survival (“PFS”) was 6.2 months, including an 18-month PFS of 30%; and

o

Median overall survival (“OS”) was 28.1 months, including a 24-month OS of 67%

Key highlights from the data supporting soquelitinib’s proposed mechanism of action (Th1 skewing and blocking Th2 and Th17 differentiation) and development in immune and inflammatory diseases include:

●

In vitro studies demonstrated that at appropriate doses, soquelitinib produced Th1 skewing, which is an immunologic property resulting from the blockade of Th2 differentiation and a shift to Th1;

●

Biomarker studies evaluating blood samples and tumor biopsies showed an increase in Th1 in blood and tumor samples and a reduction in serum IL-5, consistent with inhibiting Th2 and Th17 cells; and

●

For six patients, paired tumor biopsies were compared at baseline and day 8 and showed an increase in intratumor Th1 cells with treatment analyzed using RNA sequencing.

In August 2023, we completed an End-of-Phase/Pre-Phase 3 meeting with the Food and Drug Administration (“FDA”) regarding our plans to conduct a potentially registrational Phase 3 clinical trial of soquelitinib in

[Excerpt truncated for page length; source filing is linked above.]

## Latest 10-K MD&A

Extracted structurally from real Item 7 body heading to real Item 7A/8 boundary.
Confidence: high

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion should be read in conjunction with the consolidated financial statements and notes thereto included elsewhere in this Annual report on Form 10-K. This Annual Report on Form 10-K, including the following sections, contains forward-looking statements within the meaning of the federal securities laws. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those expressed or implied by such forward-looking statements. For a detailed discussion of these risks and uncertainties, see the “Risk Factors” section in Item 1A of this Annual Report on Form 10-K. We caution the reader not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this Form 10-K. We undertake no obligation to update forward-looking statements, which reflect events or circumstances occurring after the date of this Form 10-K.

Overview

We are a clinical stage biopharmaceutical company developing product candidates that precisely target proteins that are critical to immune cell maturation and function. We believe our proprietary product candidates have broad potential to address immune mediated diseases, inflammatory diseases and cancers.

Our lead product candidate, soquelitinib (formerly CPI-818), is designed to bind specifically to a protein, interleukin 2 inducible T cell kinase (ITK), involved in T cell activation, T cell receptor signaling and T cell differentiation and function. Based on the proposed mechanism of action, we believe soquelitinib has the potential to be utilized to inhibit the production of a number of inflammatory cytokines involved in diseases such as atopic dermatitis, hidradenitis suppurativa, asthma, psoriasis and fibrotic diseases. In preclinical studies, Soquelitinib has affected T cell differentiation leading to enhanced function of T cells involved in tumor cell eradication.

Since the immune cells targeted by our product candidates play a role in many diseases, our strategy is to leverage our research and development capabilities by evaluating our product candidates in clinical trials where there is an understanding of the role of specific T cells in the target indication and where we believe such product candidates have the broadest potential. We believe this strategy has enabled us to move rapidly from preclinical to clinical trials in diverse disease areas, each with large unmet needs. Soquelitinib entered a registrational, Phase 3 clinical trial for relapsed T cell lymphomas and is also being evaluated in a randomized, placebo-controlled Phase 2 trial in patients with atopic dermatitis. We have two additional product candidates which are in clinical development for the treatment of various solid tumors, also based on modulation of immune function.

To date, the majority of our efforts have been focused on the research, development and advancement of soquelitinib, ciforadenant, and mupadolimab, and we have not generated any revenue from product sales and, as a result, we have incurred significant losses. We expect to continue to incur significant research and development and general and administrative expenses related to our operations. Our net loss for the years ended December 31, 2025 and 2024 was $15.3 million and $62.3 million, respectively, which includes non-operating income of $27.1 million and non-operating loss of $33.4 million, respectively. As of December 31, 2025, we had an accumulated deficit of $412.3 million. We expect our losses will increase as we continue our development of, seek regulatory approval for and begin to commercialize soquelitinib, ciforadenant and mupadolimab, and as we develop other product candidates. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.

Since our inception and through December 31, 2025, we have funded our operations primarily through the sale and issuance of stock, including through our initial public offering (“IPO”) in March 2016 and subsequent follow-on public offerings. In May 2024, we completed a registered direct offering, in which we sold shares of our common stock, pre-funded warrants and common stock warrants for net proceeds of approximately $30.3 million and proceeds of $54.3 million from the exercise of common stock warrants.

On August 6, 2024, we entered into an open market sale agreement (the “2024 Sales Agreement”) with Jefferies LLC (“Jefferies”) to sell shares of our common stock, from time-to-time, with aggregate gross sales proceeds of up to $100.0 million, through an at-the-market equity offering program under which Jefferies will act as our sales agent. The issuance and sale of shares of common stock pursuant to the 2024 Sales Agreement are deemed an “at-the-market”

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offering under the Securities Act of 1933, as amended. Jefferies is entitled to compensation for its services of up to 3.0% of the gross proceeds of any shares of common stock sold through Jefferies under the 2024 Sales Agreement.

During the year ended December 31, 2025, we did not sell any shares of common stock under our at-the-market offering program and $100.0 million remained available for sale under the 2024 Sales Agreement.

In connection with the Company’s follow-on public offering in January 2026, the Company suspended the “at-the-market” offering with respect to the 2024 Sales Agreement (See Footnote 17, Subsequent Event).

Our three product candidates, soquelitinib, ciforadenant and mupadolimab, are in clinical development by us and / or our partner, Angel Pharmaceuticals. Except for Greater China, we own the world-wide rights to these product candidates.

As a result of our ongoing development efforts, we anticipate needing to spend substantial resources for the foreseeable future. Consequently, we will need additional financing to support our continuing operations. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity or debt financings or other sources, which may include collaborations with third parties. Such financing could result in dilution to stockholders and may include the imposition of debt covenants and repayment obligations or other restrictions that may affect our business. If we raise additional capital through strategic collaboration agreements, we may have to relinquish valuable rights to our product candidates, including potential future revenue streams. Adequate additional financing may not be available to us on acceptable terms, or at all. For example, the trading prices for our and other biopharmaceutical companies’ stock have been highly volatile as a result of factors such as the impacts of pandemics and increases in inflation rates or interest rates or the broad imposition of tariffs and other trade controls. As a result, we may face difficulties raising capital through sales of our common stock and any such sales may be on unfavorable terms. Our inability to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.

As of December 31, 2025, we had capital resources consisting of cash, cash equivalents and marketable securities of approximately $56.8 million and on January 23, 2026, we closed a follow-on public offering which resulted in aggregate net proceeds of approximately $189.4 million. Based on our currently available cash resources and our currently planned level of operations and cash flows, we expect that our cash resources will be sufficient to enable us to advance our programs into the second quarter of 2028. In accordance with applicable accounting standards, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern for at least the next 12 months from the date of the issuance of the consolidated financial statements included elsewhere in this Annual Report on Form 10-K and concluded that our existing cash, cash equivalents and marketable securities, including the approximate net proceeds of $189.4 million from our January 2026 follow-on public offering, are sufficient to fund our operations for at least the next 12 months from issuance of the consolidated financial statements. However, the Company will need to continue to raise additional capital to fund its operations. See “Risk Factors—Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital.”

We currently have no manufacturing capabilities and do not intend to establish any such capabilities. We have no commercial manufacturing facilities for our product candidates. As such, we are dependent on third parties to supply our product candidates according to our specifications, in sufficient quantities, on time, in compliance with appropriate regulatory standards and at competitive prices.

Components of Results of Operations

Revenue

To date, we have not generated any revenues. We do not expect to receive any revenues from any product candidates that we develop unless and until we obtain regulatory approval and commercialize our products or enter into revenue-generating collaboration agreements with third parties.

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Research and Development Expenses

Our research and development expenses consist primarily of costs incurred to conduct research and development of our product candidates. We record research and development expenses as incurred. Research and development expenses include:

●

employee-related expenses, including salaries, benefits, travel and non-cash stock-based compensation expense;

●

external research and development expenses incurred under arrangements with third parties, such as contract research organizations, preclinical testing organizations, contract manufacturing organizations, academic and non-profit institutions and consultants;

●

costs to acquire technologies to be used in research and development that have not reached technological feasibility and have no alternative future use;

●

license fees; and

●

other expenses, which include direct and allocated expenses for laboratory, facilities and other costs.

We plan to increase our research and development expenses substantially as we continue the development and potential commercialization of our product candidates. Our current planned research and development activities include the following:

●

enrollment and completion of our ongoing Phase 3 registrational clinical trial for soquelitinib in PTCL;

●

completion of our ongoing Phase 1 clinical trial for soquelitinib in atopic dermatitis;

●

completion of our Phase 1b/2 clinical trial with ciforadenant in collaboration with the Kidney Cancer Research Consortium;

●

enrollment and completion of our Phase 2 clinical trial for soquelitinib in atopic dermatitis;

●

a potential clinical trial for soquelitinib in asthma;

●

a potential clinical trial for soquelitinib in hidradenitis suppurativa;

●

process development and manufacturing of drug supply of soquelitinib; and

●

preclinical studies under our other programs in order to select development product candidates.

In addition to our product candidates that are in clinical development, we believe it is important to continue substantial investment in potential new product candidates to build the value of our product candidate pipeline and our business.

Our expenditures on current and future preclinical and clinical development programs are subject to numerous uncertainties related to timing and cost to completion. The duration, costs and timing of clinical trials and development of product candidates will depend on a variety of factors, including many of which are beyond our control. 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 uncertain. The risks and uncertainties associated with our research and development projects are discussed more fully in “Part II, Item 1A—Risk Factors.” As a result of these risks and uncertainties, we are unable to determine with any degree of certainty the duration and completion costs of our research and development projects or if, when or to what extent we will generate revenues from the commercialization and sale of

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any of our product candidates that obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our product candidates.

General and Administrative Expenses

General and administrative expenses include personnel costs, expenses for outside professional services and allocated expenses. Personnel costs consist of salaries, benefits and stock-based compensation. Outside professional services consist of legal, accounting and audit services and other consulting fees. Allocated expenses consist of rent expense related to our office and research and development facility.

We expect that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research and development and potential commercialization of one or more of our product candidates.

Results of Operations

Comparison of the periods below as indicated (in thousands):

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

  ​ ​ ​

Year ended December 31, 

  ​ ​ ​

Change

  ​ ​ ​

Change

​

​

2025

​

2024

​

2023

​

2024 to 2025

​

2023 to 2024

Operating expenses:

​

​

  ​

​

​

  ​

​

​

  ​

​

​

  ​

​

  ​

Research and development

​

$

33,719

​

$

19,385

​

$

16,526

​

$

14,334

​

$

2,859

General and administrative

​

9,252

​

8,163

​

6,881

​

1,089

​

1,282

Total operating expenses

​

42,971

​

27,548

​

23,407

​

15,423

​

4,141

Loss from operations

​

(42,971)

​

(27,548)

​

(23,407)

​

(15,423)

​

(4,141)

Interest income and other expense, net

​

2,505

​

1,824

​

1,584

​

681

​

240

Gain from sale of property and equipment

​

—

​

5

​

—

​

(5)

​

5

Change in fair value of warrant liability

​

​

27,141

​

​

(33,377)

​

​

—

​

​

60,518

​

(33,377)

Sublease income - related party

​

​

—

​

​

—

​

​

78

​

​

—

​

(78)

Loss before equity method investment

​

​

(13,325)

​

​

(59,096)

​

​

(21,745)

​

​

45,771

​

​

(37,351)

Loss from equity method investment

​

​

(1,958)

​

​

(3,197)

​

​

(5,284)

​

​

1,239

​

2,087

Net loss

​

$

(15,283)

​

$

(62,293)

​

$

(27,029)

​

$

47,010

​

$

(35,264)

​

Research and Development Expenses

Research and development expenses for the years ended December 31, 2025, 2024 and 2023, consisted of the following costs by program (specific program costs consist solely of external costs):

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

  ​ ​ ​

Year ended December 31, 

  ​ ​ ​

Change

  ​ ​ ​

Change

​

​

2025

​

2024

​

2023

​

2024 to 2025

​

2023 to 2024

Soquelitinib

​

$

21,183

​

$

8,813

​

$

5,335

​

$

12,370

​

$

3,478

​

Ciforadenant

​

​

112

  ​

​

33

  ​

​

963

  ​

​

79

  ​

​

(930)

​

Mupadolimab

​

79

​

82

​

772

​

(3)

​

(690)

​

Unallocated employee and overhead costs

​

12,345

​

10,457

​

9,456

​

1,888

​

1,001

​

​

​

$

33,719

​

$

19,385

​

$

16,526

​

$

14,334

​

$

2,859

​

​

For the year ended December 31, 2025, the increase in soquelitinib costs of $12.4 million as compared to the year ended December 31, 2024, primarily consisted of an increase of $4.8 million in drug manufacturing costs, an increase of $6.0 million in clinical trial expenses and an increase of $1.6 million in other outside service costs.

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For the year ended December 31, 2025, the increase in ciforadenant costs of $0.1 million as compared to the year ended December 31, 2024, primarily consisted of an increase in clinical trial expenses.

For the year ended December 31, 2025, the decrease in mupadolimab costs were negligible.

For the year ended December 31, 2025, the increase in unallocated employee and overhead costs of $1.9 million as compared to the year ended December 31, 2024, primarily consisted of an increase of $2.3 million in personnel and related costs and an increase of $0.4 million in outside services costs, which were partially offset by a decrease of $0.8 million in facilities related costs.

For the year ended December 31, 2024, the increase in soquelitinib costs of $3.5 million as compared to the year ended December 31, 2023, primarily consisted of an increase of $2.3 million in clinical trial expenses, an increase of $0.8 million in drug manufacturing costs and an increase of $0.4 million in other outside services.

For the year ended December 31, 2024, the decrease in ciforadenant costs of $0.9 million as compared to the year ended December 31, 2023, primarily consisted of a release of a $0.7 million legacy clinical trial accrual and a decrease of $0.2 million in other outside services.

For the year ended December 31, 2024, the decrease in mupadolimab costs of $0.7 million as compared to the year ended December 31, 2023, primarily consisted of a decrease of $0.4 million in clinical trial expenses and a decrease of $0.3 million in drug manufacturing costs.

For the year ended December 31, 2024, the increase in unallocated costs of $1.0 million as compared to the year ended December 31, 2023, primarily consisted of an increase of $0.9 million in personnel related costs and an increase of $0.1 million in other outside services.

General and Administrative Expenses

For the year ended December 31, 2025, the increase in general and administrative expenses of $1.1 million as compared to the year ended December 31, 2024, primarily consisted of an increase of $1.3 million in personnel and related costs, which were partially offset by a decrease of $0.2 million in other outside costs.

For the year ended December 31, 2024, the increase in general and administrative expenses of $1.3 million as compared to the year ended December 31, 2023, primarily consisted of an increase of $0.9 million in personnel and related costs and an increase of $0.4 million in other outside costs.

Interest Income and Other Expense, net

For the year ended December 31, 2025, the increase in interest income and other expense, net of $0.7 million as compared to the year ended December 31, 2024, primarily consisted of an increase in interest income earned due to an increase in cash equivalents and marketable securities.

For the year ended December 31, 2024, the increase in interest income and other expense, net of $0.2 million as compared to the year ended December 31, 2023, primarily consisted of an increase in interest income earned due to an increase in cash equivalents and marketable securities.

Gain from sale of property and equipment

For the year ended December 31, 2024, the gain from sale of property and equipment consisted of proceeds from the sale of laboratory equipment.

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Sublease income – related party

For the year ended December 31, 2024, the decrease in sublease income – related party of $0.1 million as compared to the year ended December 31, 2023, was due to the expiration of the building sublease agreement with Angel Pharmaceuticals’ in January 2023.

Loss from equity method investment

For the year ended December 31, 2025, the decrease in loss from equity method investment of $1.2 million as compared to the year ended December 31, 2024, primarily consisted of a decrease in Angel Pharmaceuticals’ loss for the year ended December 31, 2025.

For the year ended December 31, 2024, the decrease in loss from equity method investment of $2.1 million as compared to the year ended December 31, 2023, primarily consisted of a decrease in Angel Pharmaceuticals’ loss for the year ended December 31, 2024.

Liquidity and Capital Resources

Sources of Liquidity

As of December 31, 2025, we had cash, cash equivalents and marketable securities of $56.8 million and an accumulated deficit of $412.3 million.

Since our inception and through December 31, 2025, we have funded our operations primarily through the sale and issuance of preferred and common stock, including through our IPO in March 2016 and through subsequent follow-on public offerings. In May 2024, we complete a registered direct offering, in which we sold shares of our common stock, pre-funded warrants and common stock warrants for net proceeds of approximately $30.3 million and proceeds of $54.3 million from the exercise of common stock warrants.

During the year ended December 31, 2025, we did not sell any shares of common stock under our at-the-market offering program. As of December 31, 2025, $100.0 million remained available for sale under the 2024 Sales Agreement.

On January 23, 2026, we completed a follow-on offering of common stock, which resulted in aggregate net proceeds of approximately $189.4 million. In connection with the follow-on offering, we suspended the at-the-market offering with respect to the 2024 Sales Agreement (See footnote 17, Subsequent Event).

Funding Requirements

Since our inception, we have incurred significant losses and negative cash flows from operations. We have an accumulated deficit of $412.3 million through December 31, 2025. We do not expect positive cash flows from operations in the foreseeable future, if ever. Historically, we have incurred operating losses as a result of ongoing efforts to develop our product candidates, including conducting ongoing research and development, clinical and preclinical studies and providing general and administrative support for these operations. We do not have any products approved for sale, and we do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize any of our current and future product candidates and/or enter into additional significant collaboration agreements with third parties, and we do not know when, or if, either will occur. We expect to continue to incur net operating losses for at least the next several years and we expect the losses to increase as we advance soquelitinib, as well as any other product candidates, through clinical development, seek regulatory approval, prepare for and, if approved, proceed to commercialization and continue our research and development efforts. We are subject to all the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We do not yet have a sales organization or commercial infrastructure and, accordingly, we will need to incur significant expenses to develop a sales organization and commercial infrastructure in advance of generating any commercial product sales. Moreover,

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we incur substantial costs associated with operating as a public company. We anticipate that we will need substantial additional funding in connection with our continuing operations.

Until we can generate a sufficient amount of revenue from the commercialization of our product candidates or from additional significant collaboration or license agreements with third parties, if ever, we expect to finance our future cash needs through private and public equity offerings and potential future collaboration, license and development agreements. Adequate funding may not be available to us on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we will be required to significantly reduce our operating expenses and may have to significantly delay, scale back or discontinue the development of one or more of our current or future product candidates. If we raise additional funds by issuing equity or convertible debt securities, it could result in dilution to our existing stockholders and increased fixed payment obligations. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders. If we incur indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Additionally, any future collaborations we enter into with third parties may provide capital in the near term, but we may have to relinquish valuable rights to our product candidates or grant licenses on terms that are not favorable to us. Any of the foregoing could significantly harm our business, financial condition and prospects.

We expect to incur substantial additional losses in the future as we conduct our planned research and development activities. We believe that our existing cash, cash equivalents and marketable securities, including the net proceeds from our financing in January 2026, will be sufficient to fund our planned operating and capital needs into the second quarter of 2028. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially based on a number of factors.

We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all 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 of our operating capital requirements. Our future capital requirements depend on many factors, including:

●

the progress, timing, costs and results of clinical trials for soquelitinib, including the potential registrational clinical trial for soquelitinib, and to a lesser extent, the timing, costs and results of the clinical trials for ciforadenant and mupadolimab;

​

●

the timing, progress, costs and results of preclinical and clinical development activities for our other product candidates;

​

●

the number and scope of preclinical and clinical programs we decide to pursue;

​

●

the costs involved in prosecuting, maintaining and enforcing patent and other intellectual property rights;

​

●

the cost and timing of regulatory approvals;

​

●

our efforts to enhance operational systems and hire additional personnel, including personnel to support development of our product candidates and satisfy our obligations as a public company; and

​

●

other factors described in the section of this Annual Report on Form 10-K entitled “Risk Factors.”

​

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Summary of Statement of Cash Flows

The following table summarizes our cash flows for the periods indicated (in thousands):

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

  ​ ​ ​

Year ended December 31, 

  ​ ​ ​

Change

  ​ ​ ​

Change

​

​

2025

​

2024

​

2023

​

2024 to 2025

​

2023 to 2024

Net cash provided by (used in):

​

  ​

​

  ​

​

  ​

​

  ​

​

  ​

​

Operating activities

​

$

(32,797)

​

$

(25,424)

​

$

(23,935)

​

$

(7,373)

​

$

(1,489)

​

Investing activities

​

(7,796)

​

(27,484)

​

15,541

​

19,688

​

(43,025)

​

Financing activities

​

36,429

​

49,028

​

7,855

​

(12,599)

​

41,173

​

Net decrease in cash and cash equivalents

​

$

(4,164)

​

$

(3,880)

​

$

(539)

​

$

(284)

​

$

(3,341)

​

​

Cash Flows from Operating Activities

Cash used in operating activities during the year ended December 31, 2025 was $32.8 million, which primarily consisted of a net loss of $15.3 million, adjusted by net non-cash transactions of $21.1 million, that primarily consisted of $5.3 million of stock compensation expense, $2.0 million of loss from equity method investment and a decrease of $27.1 million in the fair value of warrant liability, a decrease of $0.9 million in prepaid and other current assets, an increase of $0.2 million in other assets, a decrease of $0.1 million in accounts payable, an increase of $2.8 million in accrued and other current liabilities and a decrease of $0.2 million in operating lease liability net of operating lease right-of-use assets amortization.

Cash used in operating activities during the year ended December 31, 2024 was $25.4 million, which primarily consisted of a net loss of $62.3 million, adjusted by net non-cash transactions of $38.5 million, that primarily consisted of $3.0 million of stock compensation expense, $3.2 million of loss from equity method investment and an increase of $33.4 million in the fair value of warrant liability, an increase of $1.6 million in prepaid and other current assets, an increase of $1.1 million in accounts payable, a decrease of $0.3 million in accrued and other current liabilities and a decrease of $0.3 million in operating lease liability net of operating lease right-of-use assets amortization.

Cash used in operating activities during the year ended December 31, 2023 was $23.9 million, which primarily consisted of a net loss of $27.0 million, adjusted by non cash charges of $6.7 million, primarily consisting of $2.1 million of stock compensation expense and $5.3 million in loss from equity method investment, a decrease of $0.5 million in accounts payable, a decrease of $3.6 million in accrued and other liabilities and a decrease of $0.6 million in accounts receivable – related party.

Cash Flows from Investing Activities

Cash used in investing activities during the year ended December 31, 2025 was $7.8 million, which consisted of purchases of marketable securities of $91.8 million and purchases of property and equipment of $0.2 million, which were partially offset by maturities of marketable securities of $84.1 million.

Cash used in investing activities during the year ended December 31, 2024 was $27.5 million, which consisted of purchases of marketable securities of $70.1 million, which were partially offset by maturities of marketable securities of $42.6 million.

Cash provided by investing activities during the year ended December 31, 2023 was $15.5 million, which consisted of proceeds from maturities of marketable securities of $62.6 million, which were partially offset by purchases of marketable securities of $47.0 million.

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Cash Flows from Financing Activities

Cash provided by financing activities during the year ended December 31, 2025 was $36.4 million, which primarily consisted of net proceeds of $35.7 million from the exercise of common stock warrants and $0.7 million from the exercise of common stock options.

Cash provided by financing activities during the year ended December 31, 2024 was $49.0 million, which primarily consisted of net proceeds of $16.4 million from the issuance of common stock, net proceeds of $5.0 million from the issuance of pre-funded warrants, proceeds of $8.9 million from the issuance of common warrants, proceeds of $18.6 million from the exercise of common warrants and proceeds of $0.1 million from the exercise of common stock options.

Cash provided by financing activities during the year ended December 31, 2023 was $7.9 million, which primarily consisted of $7.8 million in net proceeds from the issuance of common stock through our at-the-market offering program.

Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet arrangements and do not have any holdings in variable interest entities.

Contractual Obligations

Our principal commitment consists of obligations under our non-cancelable operating lease for our facilities in South San Francisco, CA that expires in 2028.

Critical Accounting Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”). The preparation of these consolidated financial statements requires our management to make judgments and estimates that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. On an ongoing basis, our management evaluates its estimates including, but not limited to: those related to the accrual for certain liabilities, including accrued clinical trial liabilities; long-lived assets; going concern assessment; and the amounts of deferred tax assets and liabilities, including the related allowance. We base our estimates 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 judgments and estimates under different assumptions or conditions and any such differences may be material. We believe our critical accounting policy relating to clinical trial accruals reflects the more significant estimates and assumptions used in the preparation of our consolidated financial statements. Our significant accounting policies are more fully described in Note 2 of Notes to Consolidated Financial Statements in Part II, Item 8 of this Annual Report on Form 10-K.

Clinical Trial Accruals

Costs for preclinical studies and clinical trial activities are recognized based on an evaluation of the vendors’ progress towards completion of specific tasks. We apply significant judgment in developing estimates for clinical trial accruals based on assumptions related to vendors’ progress towards completion. In developing these estimates, we estimate vendors’ progress towards completion using data such as clinical site activations, patient enrollment or information provided to us by our vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services are performed. We determine accrual estimates through reports from and discussions with applicable personnel and

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outside service providers as to the progress or state of completion, or the services completed. Our estimates of accrued expenses as of each balance sheet date are based on the facts and circumstances known at the time.

Recent Accounting Pronouncements

See Note 2 in Item 8 “Financial Statements and Supplementary Data.”

Segment Information

We have one primary business activity and operate as one reportable segment. See Note 4 in Item 8 “Financial Statements and Supplementary Data.”

​
