05/12/2026 | Press release | Distributed by Public on 05/12/2026 14:51
|
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. |
The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and the related notes and the other financial information included elsewhere in this Quarterly Report. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report, particularly those under "Risk Factors."
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as "may," "can," "anticipate," "assume," "should," "indicate," "would," "believe," "contemplate," "expect," "seek," "estimate," "continue," "plan," "point to," "project," "predict," "could," "intend," "target," "potential" and other similar words and expressions of the future.
There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:
The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements. Please see "Risk Factors" for additional risks which could adversely impact our business and financial performance.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith and we believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs, or projections will result or be achieved or accomplished.
-17-
Overview
Corbus Pharmaceuticals Holdings, Inc. (the "Company," "Corbus," "we," "us," or "our") is a clinical-stage company focused on developing promising new therapies in oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline includes CRB-701, a next-generation antibody drug conjugate ("ADC") for the treatment of Nectin-4-expressing tumors and CRB-913, an orally delivered highly peripherally restricted cannabinoid type-1 ("CB1") inverse agonist for the treatment of obesity.
Our pipeline:
We presented dose optimization data at the European Society for Medical Oncology ("ESMO") in October 2025. Data as of September 1, 2025 was presented from 167 patients, of whom 122 were evaluable for efficacy, from the U.S. and Europe with HNSCC, cervical, locally advanced/metastatic urothelial ("mUC") tumors and other solid-tumor types. The CRB-701 dose expansion phase of the Phase 1/2 Western study is ongoing. Updated clinical data from the Phase 1/2 study in both HNSCC and cervical cancer will be presented at the upcoming 2026 American Society of Clinical Oncology ("ASCO") Annual Meeting, to be held May 29 - June 2 in Chicago, IL. The data will include clinical response durability as well as HNSCC patient subgroup analysis. We expect to initiate a registrational study for CRB-701 in second-line HNSCC this summer. In addition, we also anticipate reporting data with CRB-701 in combination with Keytruda® in first-line HNSCC patients in Q1 2027 to support potential further registration-enabling trials.
Our pipeline formerly included CRB-601, a potent and selective anti-αvβ8 integrin monoclonal antibody for the treatment of solid tumors. CRB-601 is an anti-αvβ8 monoclonal antibody that blocks the activation of latent TGFβ present on cancer cells in the tumor microenvironment. CRB-601 was being evaluated as a potential treatment for patients with solid tumors in combination with existing therapies, including checkpoint inhibitors. We completed a Phase 1 dose escalation study. In November 2025, we presented a study-in-progress poster at the 2025 Society for Immunotherapy of Cancer conference. We have deprioritized the program and do not plan to enroll additional patients.
-18-
Financial Operations Overview
We are a clinical-stage company focused on developing promising new therapies in oncology and obesity 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 March 31, 2026, we had an accumulated deficit of approximately $578.4 million. Our net losses for the three months ended March 31, 2026 and 2025, were approximately $23.0 million and $17.0 million, respectively.
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.
We expect to continue to incur operating losses for at least the next several years in connection with our ongoing activities, as we:
Critical Accounting Policies and Estimates
Our condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires management to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, revenue, costs of expenses and related disclosures in the condensed consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments. 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.
There have been no changes to the critical accounting estimates we identified in Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2025, filed on March 9, 2026 (the "2025 Annual Report").
Results of Operations
Comparison of Three Months Ended March 31, 2026 and 2025
Operating Expense. The following table summarizes our operating expenses for the three months ended March 31, 2026 and 2025 (in thousands):
|
Three Months Ended March 31, |
||||||||||||
|
2026 |
2025 |
$ Change |
% Change |
|||||||||
|
Research and development expense |
$ |
19,819 |
$ |
15,642 |
$ |
4,177 |
27 |
% |
||||
|
General and administrative expense |
4,485 |
4,133 |
352 |
9 |
% |
|||||||
|
Total operating expenses |
$ |
24,304 |
$ |
19,775 |
$ |
4,529 |
23 |
% |
||||
Research and Development. The following table summarizes our research and development expenses for the three months ended March 31, 2026 and 2025 (in thousands):
-19-
|
Three Months Ended March 31, |
||||||||||||
|
2026 |
2025 |
$ Change |
% Change |
|||||||||
|
Program specific costs: |
||||||||||||
|
CRB-701 |
$ |
8,436 |
$ |
7,133 |
$ |
1,303 |
18 |
% |
||||
|
CRB-913 |
6,361 |
2,753 |
3,608 |
131 |
% |
|||||||
|
CRB-601 |
1,748 |
3,237 |
(1,489) |
-46 |
% |
|||||||
|
Other drug development |
114 |
120 |
(6) |
-5 |
% |
|||||||
|
Total program specific costs |
16,659 |
13,243 |
3,416 |
26 |
% |
|||||||
|
Unallocated internal costs: |
||||||||||||
|
Personnel related |
2,688 |
1,982 |
706 |
36 |
% |
|||||||
|
Other unallocated |
472 |
417 |
55 |
13 |
% |
|||||||
|
Total research and development expenses |
$ |
19,819 |
$ |
15,642 |
$ |
4,177 |
27 |
% |
||||
Research and development expenses for the three months ended March 31, 2026 totaled approximately $19.8 million, an increase of $4.2 million from approximately $15.6 million recorded for the three months ended March 31, 2025.
Total program-specific costs increased by $3.4 million for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025. Costs related to CRB-701 increased by $1.3 million as a result of higher clinical costs as additional participants are enrolled in the ongoing Phase 1/2 clinical trial, partially offset by a decrease in manufacturing costs. CRB-913 costs increased by $3.6 million primarily due to enrollment in the Phase 1b portion of the clinical study, which began in December 2025. Costs related to CRB-601 decreased by $1.5 million as the Phase 1 dose escalation study was completed and no additional patients were enrolled in Q1 2026.
Personnel-related costs increased by $0.7 million for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025. The increase is primarily due to an increase in headcount.
We have a subsidiary in each of the U.K. and Australia. During the three months ended March 31, 2026 and 2025, approximately 27% and 38% of research and development expenses, respectively, were recorded in these entities.
General and Administrative. General and administrative expense for the three months ended March 31, 2026 totaled approximately $4.5 million, an increase of $0.4 million from approximately $4.1 million recorded for the three months ended March 31, 2025. The increase in fiscal quarter 2026 as compared to fiscal quarter 2025 was attributable to an increase in compensation costs of $0.2 million primarily due to an increase in headcount and a $0.2 million increase in recruiting expense primarily due to search costs for open positions in the current year.
Other Income, Net. The following table summarizes our total other income, net for the three months ended March 31, 2026 and 2025 (in thousands):
|
Three Months Ended March 31, |
||||||||||||
|
2026 |
2025 |
$ Change |
% Change |
|||||||||
|
Interest and investment income, net |
$ |
1,402 |
$ |
1,681 |
$ |
(279) |
-17 |
% |
||||
|
Other (expense) income, net |
(67) |
1,116 |
(1,183) |
-106 |
% |
|||||||
|
Total other income, net |
$ |
1,335 |
$ |
2,797 |
$ |
(1,462) |
-52 |
% |
||||
Total other income, net for the three months ended March 31, 2026 totaled approximately $1.3 million, a decrease of $1.5 million from approximately $2.8 million recorded for the three months ended March 31, 2025. The decrease in 2026 as compared to 2025 was primarily attributable to a $1.1 million employee retention credit recorded during 2025. No employee retention credit was recorded during 2026.
Liquidity and Capital Resources
Since inception, we have experienced negative cash flows from operations. We have financed our operations primarily through sales of equity-related securities. At March 31, 2026, our accumulated deficit since inception was approximately $578.4 million.
-20-
At March 31, 2026, we had total current assets of approximately $143.6 million and current liabilities of approximately $18.1 million, resulting in working capital of approximately $125.4 million. Of our total cash, cash equivalents, investments, and restricted cash of $138.6 million at March 31, 2026, approximately $137.0 million was held within the U.S. 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. From April 1, 2026 through the date of filing, we sold 872,917 shares of our common stock pursuant to the Open Market Sale Agreement for which we received net proceeds of approximately $8.9 million. We also filed a new shelf registration statement which was declared effective on March 20, 2026 for which we are authorized to offer and sell securities up to $300.0 million.
Cash Flows
The following table summarizes our cash flows for the three months ended March 31, 2026 and 2025 (in thousands):
|
Three Months Ended March 31, |
||||||||||
|
2026 |
2025 |
|||||||||
|
Net cash used in operating activities |
$ |
(25,571 |
) |
$ |
(16,421 |
) |
||||
|
Net cash provided by investing activities |
22,455 |
18,123 |
||||||||
|
Net (decrease) increase in cash, cash equivalents, and restricted cash |
$ |
(3,116 |
) |
$ |
1,702 |
|||||
Net cash used in operating activities for the three months ended March 31, 2026 was approximately $25.6 million, which includes a net loss of approximately $23.0 million, adjusted for non-cash expenses of approximately $1.7 million primarily related to stock-based compensation expense, and approximately $4.3 million of cash used in net working capital items principally due to an increase in prepaid expenses and other current assets and a decrease in accounts payable. In April 2026, we entered into the third amendment to our existing lease of office space (the "April 2026 Lease Agreement"). The April 2026 Lease Agreement commences on December 1, 2026 and extends the term of the lease to February 29, 2032, with an option to extend the lease term for an additional period of five years upon notice to the landlord. In addition, the April 2026 Lease Agreement reduces the leased space from 62,756 square feet under the February 2019 Lease Agreement to 36,471 square feet beginning on the commencement date with new monthly base rent of approximately $65.0 thousand per month beginning March 1, 2027, with annual base rent escalation clauses during the lease term.
Cash provided by investing activities for the three months ended March 31, 2026 totaled approximately $22.5 million, which was principally related to proceeds from sales and maturities of marketable securities.
No cash was provided by financing activities for the three months ended March 31, 2026.
Future Funding Requirements
Based on current operating plans and assumptions regarding clinical timelines and other planned expenditures, we expect our cash, cash equivalents, and investments of approximately $138.2 million at March 31, 2026 will be sufficient to meet our operating and capital requirements through at least twelve months from the issuance of this Quarterly Report on Form 10-Q.
We will need to raise significant additional capital to continue to fund operations, including pre-clinical and clinical costs for our product candidates. We may seek to sell common or preferred equity or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing. In addition, we may seek to raise cash through collaborative agreements or from government grants. The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights.
The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate expenses including some or all of our planned clinical trials.
-21-
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors, other than future royalty payments under license agreements discussed as follows:
License Agreement with Jenrin
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. A $0.4 million milestone payment was achieved in the first quarter of 2025 associated with the progression into a clinical trial for CRB-913 and paid during the second quarter of 2025. The Company is obligated to pay Jenrin up to $18.0 million in additional potential milestone payments for further development of CRB-913.
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 Corbus with advance notice, and termination upon a party's insolvency or bankruptcy.
License Agreement with UCSF
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 up to $150.8 million in remaining potential milestone payments 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. During the first quarter of 2025, we paid $1.6 million under the UCSF License Agreement for previously achieved milestone payments.
The UCSF License Agreement will remain in effect until the expiration or abandonment of the last of the Patent Rights licensed. The Royalty Term is the duration of Patent Rights in that country covering the applicable Licensed Product or Licensed Services Sold in the country. The UCSF License Agreement may be terminated earlier in specified situations, including termination for material breach, termination by us with advance notice, and termination upon a party's bankruptcy.
License Agreement with CSPC
Pursuant to the terms of the license agreement with CSPC (the "CSPC License Agreement"), 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 April 2026, we paid CSPC $10.0 million pursuant to the achievement of a development milestone. 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.
The CSPC License Agreement will remain in effect on a Licensed Product and on a country-by-country basis, until the expiration of the Royalty Term of the Licensed Product in the country. The Royalty Term is the period beginning from the First Commercial Sale of the Licensed Product in the country until the later of the expiration of the last-to-expire Valid Claim in any Licensor Patent in the country that Covers the Licensed product, 10 years after the date of the First Commercial Sale in the country, or expiration of the Regulatory Exclusivity for the Licensed Product in the country. The CSPC License Agreement may be terminated earlier in specified situations, including termination for material breach, termination by Corbus with advance notice, and termination upon a party's bankruptcy.