Skip to main content

Corbus Pharmaceuticals Holdings Inc

For the period ended Dec 31, 2024. Filed Mar 11, 2025.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Mar 11, 2025

CRBP$3.07+7.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-K

Period ended 2023-12-31; filed 2024-03-12.

0000950170-24-030133

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

Current report: 10-K

Period ended 2024-12-31; filed 2025-03-11.

0000950170-25-037335

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

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 81 previous paragraphs and 99 current paragraphs.

40 unchanged; 25 reworded; 34 added; 16 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 1 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (34)

Current report

On June 1, 2024, CSPC presented updated Phase 1 dose escalation clinical data at the American Society of Clinical Oncology (“ASCO”) Annual General Conference building upon the data presented at ASCO Genitourinary Cancers Symposium (“ASCO GU”) on January 26, 2024. The larger data set included 37 patients of whom 25 patients reflective of seven dose levels had been evaluated for efficacy at the time of the data cut. The emerging clinical data showed that CRB-701 was well-tolerated and demonstrated an overall response rate ("ORR") of 44% and a disease control rate ("DCR") of 78% in mUC and 43% ORR and 86% DCR in cervical cancer. No dose limiting toxicities (“DLTs”) were observed in doses up to and including 4.5 mg/kg.

Current report

On February 14, 2025, we presented Phase 1 dose escalation data from the Western study at ASCO GU 2025. The Western study was conducted at clinical sites in the U.S. and U.K. and enrolled participants with mUC and other solid tumors associated with Nectin-4 expression. These included several tumor types not previously explored by CSPC in the China study. Unlike the China study, participants in the Western study were recruited regardless of their individual Nectin-4 levels. The Western study opened for enrollment in April 2024 and enrollment for dose escalation was completed in October 2024. A December 2024 data cut was presented at ASCO GU (n=38) of whom 26 participants were evaluable for efficacy. The Western study enrolled participants into the top four dose cohorts used in the China study (1.8, 2.7, 3.6 and 4.5 mg/kg) and adopted the same Q3W regimen. Responses were observed in mUC (1 partial response, n=4), cervical cancer (1 complete response, n=2), head and neck squamous cell carcinoma ("HNSCC") (4 partial responses, n=7) and endometrial cancer (1 partial response, n=2). No DLTs were observed and the drug was generally well-tolerated. The dose optimization portion in the Phase 1 Western study is currently ongoing. Participants are being randomized to the 2.7 mg/kg and 3.6 mg/kg cohorts in HNSCC, cervical and mUC tumors.

Current report

CRB-913 is a second-generation highly peripherally restricted CB1 receptor inverse agonist designed to treat obesity. We have completed IND-enabling studies and expect to dose the first patient in a Phase 1 study in the first quarter of 2025. CB1 inverse agonism is a highly clinically validated mechanism to induce weight loss, however, neuropsychiatric adverse events have been reported in prior clinical studies with both rimonabant and monlunabant. CRB-913 has been specifically formulated to shift the drug exposure from the brain to the periphery to improve safety and tolerability. The drug has a brain to plasma ratio fifty times lower than rimonabant and fifteen times more peripherally restricted than monlunabant.

Current report

Our research and development expense has historically consisted primarily of the following:

Current report

compensation, employee benefits and other staff-related expenses of personnel involved in research and development activities;

Current report

external research and development costs incurred under agreements with contract research organizations and consultants to conduct our clinical trials and other pre-clinical studies;

Current report

costs related to manufacturing and purchasing of our product candidates;

Current report

costs associated with the licensing of research and development programs; and

Current report

allocated expenses, including equipment, insurance and costs of facilities.

Current report

Research and development activities are the focus of our business model. We expect that our research and development expenses will increase in the future in connection with the continuation of clinical trials across all our programs.

Current report

General and administrative expense primarily consists of compensation, employee benefits and travel expenses of personnel in our executive, finance, legal, human resources, and other administrative functions. Other costs include legal fees related to intellectual property and corporate matters, insurance costs, facilities costs not otherwise included in research and development expense, board compensation, professional fees for accounting, tax, and investor relations services, and information technology expense.

Current report

We anticipate that our general and administrative expenses will increase in the future to support increased and progressed research and development activities and to operate as a public company.

Current report

Interest income consists of interest and investment income earned on our cash equivalents and investments.

Current report

Interest expense relates primarily to interest expense on a loan from K2 HealthVentures LLC. The loan was repaid in full on August 1, 2024.

Current report

Other income, net includes refundable research and development credits from foreign tax authorities, as well as changes in derivative liabilities and foreign currency exchange gains and losses.

Current report

fees paid to our licensing partner for drug product utilized in clinical trials;

Current report

Operating Expenses. The following table summarizes our operating expenses for the years ended December 31, 2024 and 2023 (in thousands):

Current report

Research and Development. The following table summarizes our research and development expenses for the years ended December 31, 2024 and 2023 (in thousands):

Current report

Research and development expenses for the year ended December 31, 2024 totaled approximately $32.2 million, an increase of $1.1 million over the $31.2 million recorded for the year ended December 31, 2023.

Current report

Total program-specific costs increased by 1.0 million in 2024 as compared to 2023. Costs related to CRB-601 decreased by $9.1 million as a result of lower manufacturing costs, as well as two milestones totaling $2.4 million under the UCSF License Agreement that were incurred in 2023. Costs related to CRB-701 increased by $3.5 million as a result of higher clinical and drug supply related costs as enrollment began in 2024 in the Phase 1 clinical trial offset by a $7.5 million upfront cost incurred in 2023 associated with the CSPC License Agreement. CRB-913 costs increased by $7.1 million due to the manufacturing of drug supply and IND-enabling studies to support the filing of an IND and the planned commencement of the Phase 1 clinical study for CRB-913.

Current report

Unallocated research and development costs were comparable between December 31, 2024 and December 31, 2023.

Current report

Other Income (Expense), Net. The following table summarizes our other income (expense), net for the years ended December 31, 2024 and 2023 (in thousands):

Current report

The following table summarizes our cash flows for the years ended December 31, 2024 and December 31, 2023 (in thousands):

Current report

Cash provided by financing activities for the year ended December 31, 2024 totaled approximately $166.6 million. This is mainly related to proceeds from issuance of common stock under an open market sale agreement, as well as a public offering as noted below.

Current report

On May 31, 2023, we entered into Amendment No. 1 to the Open Market Sale Agreement originally dated August 6, 2020 (as amended, the “Open Market Sale Agreement”) with Jefferies LLC ("Jefferies"), as sales agent. Under the Open Market Sale Agreement, we may issue and sell, from time to time through Jefferies, shares of its common stock having an aggregate offering price of up to $150.0 million (the “2024 Open Market Offering”).

Current report

Under the Open Market Sale Agreement, Jefferies may sell the common stock by any method permitted by law deemed to be an “at-the-market offering” as defined by Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. we may sell common stock in amounts and at times to be determined by us subject to the terms and conditions of the Open Market Sale Agreement, but we have no obligation to sell any of the common stock in the 2024 Open Market Offering.

Current report

During the years ended December 31, 2024 and 2023, we sold an aggregate of 2,484,517 and 14,106 shares of common stock, respectively, under the Open Market Sale Agreement, for net proceeds of approximately $91.4 million and $0.1 million, respectively. As of December 31, 2024, approximately $76.4 million was available for issuance and sale under the 2024 Open Market Offering.
Removed paragraphs (16)

Previous report

CRB-913 is a second-generation highly peripherally restricted CB1 receptor inverse agonist designed to treat obesity. In a DIO mouse model, CRB-913 demonstrates a reduction in body weight, body fat content, leptinemia, insulin resistance, liver triglycerides, liver fat deposits, and improvements in liver histology. These outcomes were further improved when CRB-913 was used in combination with incretin analogs (tirzepatide, semaglutide, or liraglutide). We are currently conducting IND enabling studies and we expect to file an IND in the fourth quarter of 2024.

Previous report

On May 31, 2023, we entered into the Open Market Sale Agreement with Jefferies pursuant to which Jefferies is serving as the sales agent to sell shares of our common stock through an “at-the-market offering.” Since May 31, 2023, we have sold shares of our common stock under the Open Market Sale Agreement to raise aggregate gross proceeds of approximately $114,000 through December 31, 2023 and approximately $21,237,000 through this filing.

Previous report

On January 30, 2024, we delivered written notice to Jefferies suspending and terminating the prospectus supplement dated January 29, 2024 (the “ATM Prospectus Supplement”), related to our common stock issuable pursuant to the Open Market Sale Agreement, pursuant to the terms of the Open Market Sale Agreement. We will not make any sales of our securities pursuant to the Open Market Sale Agreement, unless and until a new shelf registration statement and prospectus supplement are filed. Other than the termination of the ATM Prospectus Supplement, the Open Market Sale Agreement remains in full force and effect.

Previous report

Stock options are granted with an exercise price at no less than fair market value at the date of the grant. The stock options normally expire ten years from the date of grant. Stock option awards vest upon terms determined by our Board of Directors.

Previous report

We lease our office space. We determine if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities, current and noncurrent in our consolidated balance sheets. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As our leases do not provide an implicit rate, we use an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate we would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term.

Previous report

We have subleased a portion of our leased facility under an agreement considered to be an operating lease according to U.S. GAAP. We have not been legally released from our primary obligations under the original lease and therefore it continues to account for the original lease as it did before commencement of the sublease. We will record both fixed and variable payments received from the sublessee in our statement of operations on a straight-line basis as an offset to rent expense.

Previous report

Research and Development. Research and development expenses for the year ended December 31, 2023 totaled approximately $31,168,000, an increase of $15,031,000 over the $16,137,000 recorded for the year ended December 31, 2022. The increase in fiscal 2023 as compared to fiscal 2022 was primarily attributable to an increase in licensing costs of $7,500,000 associated with the CSPC License Agreement and $2,325,000 associated with the achievement of two development milestones under the UCSF License Agreement, as well as increases of $4,317,000 in manufacturing costs associated with the production and testing of CRB-601, $3,041,000 in pre-clinical and clinical costs to advance our pipeline to prepare for the start of clinical trials, and $1,309,000 in consulting and temporary employee costs to support various areas of regulatory, quality, manufacturing, and clinical operations. These increases are offset by a decrease in toxicology costs of $2,738,000 as a result of IND-enabling studies completed in the prior year for inclusion in the CRB-601 IND filing and a decrease in compensation costs of $1,328,000 as a result of reduced headcount.

Previous report

Research and development expenses are expected to decrease in 2024 as upfront payments associated with licensing CRB-701 are not expected to recur and we incurred significant expenses in 2023 to manufacture CRB-601 for clinical studies.

Previous report

Litigation Settlement. There was no litigation settlement for the year ended December 31, 2023. Litigation Settlement expense for the year ended December 31, 2022 totaled $5,000,000 as a result of the settlement with Venn Therapeutics, LLC.

Previous report

In addition to refundable research and development tax credits that were earned on certain research and development expenses incurred primarily outside of the U.S., other income (expense), net consists of interest income we earn on interest-bearing accounts, realized investment gains and losses, interest expense incurred on our outstanding debt, changes in derivative liabilities, and realized and unrealized foreign currency exchange gains and losses.

Previous report

We expect other income (expense), net to increase in 2024 due to the receipt of the current year refundable research and development credits along with the application and receipt of next year's refundable research and development credits.

Previous report

Cash used in financing activities for the year ended December 31, 2023 totaled approximately $2,821,000, which related to the repayment of long-term borrowings of $2,821,000 in connection with our Loan and Security Agreement with K2HV.

Previous report

The Milky Way License Agreement will remain in effect on a Licensed Product-by-License Product and country-by-country basis, until the expiration of the Royalty Term of the Licensed Product in the country. The "Royalty Term" means the period beginning from the First Commercial Sale of the Licensed Product in the country until the expiration of the last-to-expire Valid Claim in any Licensor Patent in the country that covers the composition of matter of the Licensed Product, the manufacture of the Licensed Product in the country, or a method of use of the Licensed Product for an indication for which Regulatory Approval has been obtained in the country. The Milky Way License Agreement may be terminated earlier in specified situations, including termination for material breach or termination by us with advance notice. A notice of termination without reason was executed by us and sent to Milky Way BioPharma, LLC on January 25, 2024.
Reworded paragraphs (25)

Previous wording

We are a precision oncology company with a diversified portfolio and are committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline is comprised of two experimental drugs targeting solid tumors: CRB-701, a next-generation ADC that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity.

Current wording

We are an oncology and obesity company with a diversified portfolio and are committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline is comprised of two experimental drugs targeting solid tumors: CRB-701, a next-generation antibody drug conjugate ("ADC") that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload of monomethyl auristatin E ("MMAE") and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 ("CB1") receptor inverse agonist for the treatment of obesity.

Previous wording

CRB-701 is a next-generation ADC that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload. In February 2023, we obtained a license from CSPC to develop and commercialize the drug in the U.S., Canada, the European Union (including the European Free Trade Area), the United Kingdom, and Australia. The IND application for CRB-701 was cleared by the U.S. FDA in 2022, and the drug is currently being investigated by CSPC in a Phase 1 dose-escalation clinical trial in patients with advanced solid tumors in China. On January 26, 2024, we presented data from the Phase 1 dose-escalation trial in China for the first eighteen patients reflective of the first six dose cohorts. The data was presented at ASCO-GU. The emerging clinical data shows that CRB-701 was well-tolerated and demonstrated an ORR of 43% and a DCR of 71% in the seven patients who received doses predicted to be therapeutically relevant. We are on schedule to bridge data from this Phase 1 clinical trial in China to commence a Phase 1 clinical trial in the U.S. during the first quarter of 2024.

Current wording

CRB-701 is a next-generation ADC that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload of MMAE. In February 2023, we obtained a license from CSPC Megalith Biopharmaceutical Co. Ltd. ("CSPC"), a subsidiary of CSPC Pharmaceutical Group Limited, to develop and commercialize the drug in the United States (“U.S.”), Canada, the European Union (including the European Free Trade Area), the United Kingdom (“U.K.”) and Australia. CRB-701 is currently being investigated by CSPC in a Phase 1 dose expansion clinical trial in patients with advanced solid tumors in China (the "China study"). We commenced a corresponding Phase 1 dose escalation study in the U.S. and the U.K. (the "Western study") in April 2024 and completed enrollment of the dose escalation phase in October 2024. The dose optimization portion in the Western study is currently ongoing and we are in the process of adding additional clinical sites in Europe. Both studies are enrolling patients with advanced solid tumors associated with Nectin-4 expression.

Previous wording

CRB-601 is a potent and selective anti-αvβ8 monoclonal antibody that blocks the activation of latent TGFβ found on cancer cells. In pre-clinical models, CRB-601 demonstrates enhanced anti-tumor activity when combined with an anti-PD-1 checkpoint inhibitor compared to each single agent on its own. The data suggests that blockade of latent TGFβ production by CRB-601 can lead to changes in immune cell infiltration in the tumor microenvironment thus potentially enhancing the benefit of PD-1 blockade. CRB-601 is being developed as a potential treatment for patients with solid tumors in combination with existing therapies, including checkpoint inhibitors. On January 9, 2024, we announced that the FDA cleared the IND for CRB-601 and we expect to enroll the first patient in a Phase 1 study in the summer of 2024.

Current wording

CRB-601 is a potent and selective anti-αvβ8 monoclonal antibody that blocks the activation of latent TGFβ found on cancer cells. In pre-clinical models, CRB-601 demonstrates enhanced anti-tumor activity when combined with an anti-PD-1 checkpoint inhibitor compared to each single agent on its own. Pre-clinical data suggests that blockade of latent TGFβ production by CRB-601 can lead to changes in immune cell infiltration in the tumor microenvironment, thus potentially enhancing the benefit of PD-1 blockade. CRB-601 is being developed as a potential treatment for patients with solid tumors in combination with existing therapies, including checkpoint inhibitors. The first patient in a Phase 1 dose escalation study was enrolled in December 2024 under an open IND and regulatory approval for the study was received in the U.K. in January 2025.

Previous wording

We are a precision oncology company and have not generated any revenues from the sale of products. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for the marketing of one of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. We have never been profitable and at December 31, 2023, we had an accumulated deficit of approximately $436,684,000. Our net losses for the years ended December 31, 2023 and December 31, 2022 were approximately $44,603,000 and $42,347,000, respectively.

Current wording

We are an oncology and obesity company and have not generated any revenues from the sale of products. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for the marketing of one of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. We have never been profitable and at December 31, 2024, we had an accumulated deficit of approximately $476.9 million. Our net losses for the years ended December 31, 2024 and 2023 were approximately $40.2 million and $44.6 million, respectively.

Previous wording

We expect to continue to incur significant expenses for the foreseeable future. We expect our expenses to decline in 2024 as compared to 2023 as the upfront license payment to purchase CRB-701 in 2023 of $7,500,000 will not recur and we incurred significant expenses in 2023 to manufacture CRB-601 for clinical studies. We will continue to incur significant operating losses as we move into the clinical phase and, accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity, debt financings or other sources, which may include government grants and collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure 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 revenues to achieve profitability, and we may never do so.

Current wording

We expect to continue to incur significant expenses for the foreseeable future. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of our product candidates. We will continue to incur significant operating losses as we move into the clinical phase and, accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity, debt financings or other sources, which may include government grants and collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure 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 revenues to achieve profitability, and we may never do so.

Previous wording

On an ongoing basis, we evaluate our estimates and judgments for all assets and liabilities, including those related to accrued research and development expense, stock-based compensation expense, and operating lease right-of-use assets and liabilities. We base our estimates and judgments on historical experience, current economic and industry conditions and on various other factors that are believed to be reasonable under the circumstances. This forms the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. See Note 3 “Significant Accounting Policies” to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K for information about our significant accounting policies.

Current wording

On an ongoing basis, we evaluate our estimates and judgments for all assets and liabilities, including those related to accrued research and development expense and stock-based compensation expense. We base our estimates and judgments on historical experience, current economic and industry conditions and on various other factors that are believed to be reasonable under the circumstances. This forms the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. See Note 3 “Significant Accounting Policies” to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K for information about our significant accounting policies.

Previous wording

We base our expense accruals related to pre-clinical and clinical activities on our estimates of the services performed pursuant to contracts with multiple research institutions and clinical research organizations that conduct and manage pre-clinical and clinical work on our behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors, such as the successful animal trials and the completion of study milestones. Our service providers invoice us monthly in arrears for services performed. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If we do not identify costs that we have begun to incur, or if we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates.

Current wording

We base our expense accruals related to pre-clinical and clinical activities on our estimates of the services performed pursuant to contracts with multiple research institutions and CROs that conduct and manage pre-clinical and clinical work on our behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors, such as the successful animal trials and the completion of study milestones. Our service providers invoice us monthly in arrears for services performed. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If we do not identify costs that we have begun to incur, or if we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates.

Previous wording

We recognize compensation costs resulting from the issuance of stock-based awards to employees, members of our Board of Directors and consultants. The fair value of each option grant was estimated as of the date of grant using the Black-Scholes option-pricing model. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. We estimate volatility by analyzing the volatility of the trading price of our common stock. We use historical data, as well as subsequent events occurring prior to the issuance of the consolidated financial statements, to estimate option exercise and employee forfeitures within the valuation model. The expected term of options granted to employees under our stock plans is based on the average of the contractual term (generally 10 years) and the vesting period (generally 48 months). The expected term of options granted under the 2014 Plan, all of which qualify as “plain vanilla” per SEC Staff Accounting Bulletin 107, is based on the average of the 6.25 years. For non-employee options, the expected term is the contractual term. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the option. We estimate the forfeiture rate at the time of grant and revise it, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on management’s expectation through industry knowledge and historical data. We have never paid dividends on our common stock and do not anticipate paying dividends on our common stock in the foreseeable future. Accordingly, we have assumed no dividend yield for purposes of estimating the fair value of our stock-based compensation.

Current wording

We recognize compensation expense for stock-based awards, including grants of restricted stock units and stock options, granted to employees, non-employee directors and non-employee consultants based on the estimated fair value on the date of grant, over the requisite service period. The fair value of restricted stock units was estimated based on the market price of our common stock on the date of grant. The fair value of each stock option grant was estimated as of the date of grant using the Black-Scholes option-pricing model. We estimate volatility by analyzing the volatility of the trading price of our common stock. The expected term of employee and non-employee director stock options granted under our stock plans, all of which qualify as “plain vanilla” per SEC Staff Accounting Bulletin 107, is determined based on the simplified method due to our limited operating history. The expected term is applied to the stock option grant group as a whole, as we do not expect substantially different exercise or post-vesting termination behavior among our employee population. For non-employee stock options, excluding directors, we have elected to utilize the contractual term as the expected term. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with that used to value the stock option. We account for forfeitures as they occur. We have never paid dividends on our common stock and do not anticipate paying dividends on our common stock in the foreseeable future. Accordingly, we have assumed no dividend yield for purposes of estimating the fair value of our stock-based compensation.

Previous wording

The following assumptions were used to estimate the fair value of employee stock options granted using the Black-Scholes option pricing model for the years ended December 31, 2023 and 2022 is as follows:

Current wording

The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes option pricing model for the years ended December 31, 2024 and 2023:

Previous wording

Revenue from Awards. No revenue from awards was recognized for the years ended December 31, 2023 and 2022 in accordance with U.S. GAAP. No revenue from licenses was recognized for the years ended December 31, 2023 and 2022.

Current wording

Revenue from Awards. No revenue was recognized for the years ended December 31, 2024 and 2023 in accordance with U.S. GAAP.

Previous wording

During 2018, we formed subsidiaries in the United Kingdom and Australia and approximately 36% and 43% of research and development expenses recorded for the years ended December 31, 2023 and December 31, 2022 respectively were recorded in these entities.

Current wording

We have a subsidiary in each of the U.K. and Australia and approximately 37% and 36% of research and development expenses recorded for the years ended December 31, 2024 and 2023 respectively were recorded in these entities.

Previous wording

General and Administrative. General and Administrative expenses for the year ended December 31, 2023 totaled approximately $13,910,000, a decrease of $4,789,000 from the $18,699,000 recorded for the year ended December 31, 2022. The decrease in fiscal 2023 as compared to fiscal 2022 was primarily attributable to decreases in stock-based compensation costs of $2,050,000 as stock options are being granted at lower current fair values as compared to earlier grants that are now fully vested, legal costs of $1,492,000 related to the litigation with Venn Therapeutics, LLC, $773,000 in reduced premiums associated with insurance policies, and $640,000 in consulting costs for various consultants who supported finance, business development, and information technology.

Current wording

General and Administrative. General and Administrative expenses for the year ended December 31, 2024 totaled approximately $16.5 million, an increase of $2.6 million from the $13.9 million recorded for the year ended December 31, 2023. The increase in fiscal 2024 as compared to fiscal 2023 was primarily attributable to increases in stock-based compensation costs of $2.0 million primarily due to awards being granted at higher current fair values as compared to earlier grants, a $0.8 million increase in professional services to support operations, and a $0.3 million increase in franchise taxes. These costs are partially offset by a decrease in personnel-related costs of $0.8 million associated with prior year reductions in headcount.

Previous wording

Other Income (Expense), Net. Other income (expense), net for 2023 was income of approximately $474,000 as compared to expense of approximately $2,511,000 recorded for 2022. The increase of $2,985,000 in 2023 as compared to 2022 was primarily attributable to receipt of refundable research and development credits from a foreign tax authority of approximately $2,632,000 related to the prior year that were not realized until 2023.

Current wording

Other income (expense), net for 2024 was approximately $8.5 million as compared to approximately $0.5 million recorded for 2023. The increase of $8.0 million in 2024 as compared to 2023 was primarily attributable to higher interest and investment income of $4.7 million due to higher cash and investment balances, reduced interest expense of $2.0 million as principal payments were made on debt in 2024 and an increase in refundable research and development credits from a foreign tax authority of $1.4 million.

Previous wording

Since inception, we have experienced negative cash flows from operations. We have financed our operations primarily through sales of equity-related securities. At December 31, 2023, our accumulated deficit since inception was approximately $436,684,000.

Current wording

Since inception, we have experienced negative cash flows from operations. We have financed our operations primarily through sales of equity-related securities. At December 31, 2024, our accumulated deficit since inception was approximately $476.9 million.

Previous wording

At December 31, 2023, we had total current assets of approximately $23,546,000 and current liabilities of approximately $31,894,000 resulting in negative working capital of approximately $8,348,000. Of our total cash, cash equivalents, investments, and restricted cash of $21,576,000 at December 31, 2023, $17,804,000 was held within the U.S.

Current wording

At December 31, 2024, we had total current assets of approximately $153.0 million and current liabilities of approximately $11.8 million resulting in working capital of approximately $141.2 million. Of our total cash, cash equivalents, investments, and restricted cash of $149.7 million at December 31, 2024, $144.9 million was held within the U.S.

Previous wording

Net cash used in operating activities for the year ended December 31, 2023 was approximately $36,100,000 which includes a net loss of approximately $44,603,000, adjusted for non-cash expenses of approximately $4,409,000, principally related to stock-based compensation expense of $3,470,000, amortization of debt discount of $824,000, depreciation and amortization expense of $641,000, and net amortization on discount of investments of $506,000, and approximately $4,094,000 of cash used by net working capital items, principally related to the increases in accrued expenses of $5,031,000 and accounts payable of $1,028,000 and a decrease in operating lease right-of-use asset amortization of $821,000 offset by an increase in prepaid expenses of $1,470,000 and a decrease in operating lease liabilities of $1,281,000.

Current wording

Net cash used in operating activities for the year ended December 31, 2024 was approximately $41.8 million which includes a net loss of approximately $40.2 million, adjusted for non-cash expenses of approximately $4.0 million, largely related to stock-based compensation expense offset by net amortization of premiums and discounts on investments and approximately $5.6 million of cash used by net working capital items, principally related to decreases in accrued expenses and operating lease liabilities, as well as an increase in accounts payable and prepaid expenses and other current assets due to the timing in which we pay our vendors.

Previous wording

Cash provided by investing activities for the year ended December 31, 2023 totaled approximately $35,642,000, which was largely due to the proceeds from sales and maturities of investments, net of purchases.

Current wording

Cash used by investing activities for the year ended December 31, 2024 totaled approximately $121.3 million, which was largely due to purchases of investments, partially offset by proceeds from sales and maturities of investments.

Previous wording

On January 31, 2024, we entered into an underwriting agreement with Jefferies, as Representative of the Underwriters, relating to an underwritten public offering of 4,325,000 shares of our common stock at a price to the public of $19.00 per share. The Underwriters were also granted a 30-day option to purchase up to an additional 648,750 shares of common stock at the public offering price. On January 31, 2024, the Representative gave notice of the Underwriters’ election to exercise the option to purchase additional shares, in full. On February 2, 2024, we completed the public offering raising gross proceed of approximately $94,500,000 and net proceeds of $88,500,000 after deducting underwriting discounts and commissions and other estimated offering expenses payable by us.

Current wording

On January 31, 2024, we entered into an underwriting agreement with Jefferies, as representative of the several underwriters, relating to an underwritten public offering of 4,325,000 shares of our common stock, par value $0.0001, at a price to the public of $19.00 per share. The underwriters were also granted a 30-day option to purchase up to an additional 648,750 shares of common stock at the public offering price. On January 31, 2024, Jefferies gave notice to us of the underwriters’ election to exercise the option to purchase additional shares, in full. On February 2, 2024, we completed the public offering raising gross proceeds of approximately $94.5 million and net proceeds of $88.6 million after deducting underwriting discounts and commissions and other offering expenses payable by us.

Previous wording

We expect our cash, cash equivalents, and investments of approximately $20,906,000 at December 31, 2023 together with net proceeds raised from the sale of our common stock under the Open Market Sales Agreement and the January 2024 Public Offering of approximately $109,000,000 after deducting commissions and other offering expenses payable by us will be sufficient to meet our operating and capital requirements to support our operations through the first quarter of 2027, based on current planned expenditures.

Current wording

We expect our cash, cash equivalents, and investments of approximately $149.1 million at December 31, 2024 will be sufficient to meet our operating and capital requirements to support our operations through the third quarter of 2027, based on current planned expenditures.

Previous wording

Our contractual obligations as of December 31, 2023 consist of our amended lease agreement (“February 2019 Lease Agreement”) for an aggregate total of 62,756 square feet of leased office space (“Total Premises”) through November 30, 2026. Total rent expense for the year ended December 31, 2023 was $1,700,005 and we do not expect any significant changes in future periods. In addition, we entered into a sublease agreement with a third party to sublease 12,112 square feet of our leased space. The sublease commenced on October 1, 2021 and was contracted to end October 31, 2026. Rent expense for the year ended December 31, 2023 was offset by $226,153 of sublease income. We are in the process of terminating the sublease agreement and do not expect any additional sublease income beyond the first quarter of 2024.

Current wording

Our contractual obligation as of December 31, 2024 consist of our amended lease agreement (“February 2019 Lease Agreement”) for an aggregate total of 62,756 square feet of leased office space (“Total Premises”) through November 30, 2026. Total rent expense for the year ended December 31, 2024 was $1.7 million and we do not expect any significant changes in future periods. In addition, we entered into a sublease agreement with a third party to sublease 12,112 square feet of our leased space. The sublease commenced on October 1, 2021 and was contracted to end October 31, 2026. We terminated the sublease agreement on June 24, 2024.

Previous wording

Pursuant to the terms of the Jenrin License Agreement, we are obligated to pay potential milestone payments to Jenrin totaling up to $18.4 million for each compound we elect to develop based upon the achievement of specified development and regulatory milestones. In addition, we are obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, as defined in the Jenrin License Agreement, subject to specified reductions.

Current wording

Pursuant to the terms of the license agreement (the "Jenrin License Agreement") with Jenrin Discovery, LLC (“Jenrin”), we are obligated to pay potential milestone payments to Jenrin totaling up to $18.4 million for each compound we elect to develop based upon the achievement of specified development and regulatory milestones. In addition, we are obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, as defined in the Jenrin License Agreement, subject to specified reductions.

Previous wording

The Jenrin License Agreement terminates on a country-by-country and product-by-product basis upon the expiration of the royalty term for such product in such country. Each royalty term begins on the date of the first commercial sale of the licensed product in the applicable country and ends on the later of seven years from such first commercial sale or the expiration of the last to expire of the applicable patents in that country. The Jenrin License Agreement may be terminated earlier in specified situations, including termination for uncured material breach of the Jenrin License Agreement by either party, termination by Jenrin in specified circumstances, termination by us with advance notice and termination upon a party’s insolvency or bankruptcy.

Current wording

The Jenrin License Agreement terminates on a country-by-country basis and product-by-product basis upon the expiration of the royalty term for such product in such country. Each royalty term begins on the date of the first commercial sale of the licensed product in the applicable country and ends on the later of seven years from such first commercial sale or the expiration of the last to expire of the applicable patents in that country. The Jenrin License Agreement may be terminated earlier in specified situations, including termination for uncured material breach of the Jenrin License Agreement by either party, termination by Jenrin in specified circumstances, termination by us with advance notice, and termination upon a party’s insolvency or bankruptcy.

Previous wording

Pursuant to the terms of the Milky Way License Agreement, we are obligated to pay potential milestone payments to Milky Way totaling up to $53.0 million based upon the achievement of specified development and regulatory milestones. In addition, we are obligated to pay Milky Way royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the Milky Way License Agreement.

Current wording

Pursuant to the terms of the license agreement (the "Milky Way License Agreement") with Milky Way BioPharma, LLC (“Milky Way”), we were obligated to pay potential milestone payments to Milky Way totaling up to $53.0 million based upon the achievement of specified development and regulatory milestones. In addition, we were obligated to pay Milky Way royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the Milky Way License Agreement. A notice of termination without reason was executed by us and sent to Milky Way on January 25, 2024, terminating the Milky Way Agreement effective as of July 23, 2024.

Previous wording

Pursuant to the terms of the UCSF License Agreement, we are obligated to pay potential milestone payments to UCSF totaling up to $153.15 million based upon the achievement of specified development and regulatory milestones, excluding indication milestones for antibodies used for diagnostic products and services that will be an additional $50,000 for each new indication. In addition, we are obligated to pay UCSF royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the UCSF License Agreement, and any diagnostic products and services.

Current wording

Pursuant to the terms of the license agreement (the "UCSF License Agreement") with the Regents of the University of California, we are obligated to pay potential milestone payments totaling up to $153.2 million based upon the achievement of specified development and regulatory milestones, excluding indication milestones for antibodies used for diagnostic products and services that will be an additional $50.0 thousand for each new indication. In addition, we are obligated to pay royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the UCSF License Agreement, and any diagnostic products and services.

Previous wording

Pursuant to the terms of the CSPC License Agreement, we are obligated to pay potential milestone payments to CSPC totaling up to $130 million based upon the achievement of specified development and regulatory milestones and $555 million in potential commercial milestone payments. In addition, we are obligated to pay CSPC royalties in the low double digits based on net sales of any Licensed Products, as defined in the CSPC License Agreement.

Current wording

Pursuant to the terms of the license agreement (the "CSPC License Agreement") with CSPC, we are obligated to pay potential milestone payments to CSPC totaling up to $130.0 million based upon the achievement of specified development and regulatory milestones and $555.0 million in potential commercial milestone payments. In addition, we are obligated to pay CSPC royalties in the low, double digits based on net sales of any Licensed Products, as defined in the CSPC License Agreement.