CRBP

RISK FACTORS An investment in our common stock is highly speculative and involves a high degree of risk, including the risk of a loss of your entire investment.
If any of the following risks occur, our business, financial condition, results of operations and stock price could be materially adversely affected.
All our product candidates are in the discovery stage, pre-clinical, or clinical development stage.
We must complete clinical studies and other development activity and receive regulatory approval of a marketing application before commercial sales of a product can commence.
Our net loss was approximately $78.5 million and $40.2 million, for the years ended December 31, 2025 and 2024, respectively.
As of December 31, 2025, we had an accumulated deficit of approximately $555.4 million.
As of December 31, 2025, we held cash, cash equivalents, and investments of approximately $163.3 million.
Under the Open Market Sale Agreement, we may issue and sell, from time to time through Jefferies, shares of our common stock having an aggregate offering price of up to $150.0 million (the “Open Market Offering”).
For the year ended December 31, 2025, we sold an aggregate of 563,504 shares of common stock for net proceeds of approximately $7.0 million under the Open Market Sale Agreement.
As of December 31, 2025, approximately $69.1 million is available for issuance and sale under the Open Market Offering.
On October 30, 2025, we entered into an underwriting agreement with Jefferies, as representative (the "Representative") of the several underwriters (the "Underwriters"), relating to an underwritten public offering of 4,744,231 shares of our common stock at a price to the public of $13.00 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase 1,025,000 shares of common stock at a public offering price of $12.9999 per pre-funded warrant.
The purchase price per share of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant.
On November 3, 2025, we completed the public offering raising net proceeds of $70.2 million after deducting underwriting discounts and commissions and other offering expenses payable by us.
CRB-701 is currently in a Phase 1/2 study in the U.S. and Europe conducted by us (referred to herein as the Western study) and a Phase 3 clinical trial being conducted in China by CSPC (referred to herein as the China study).
CRB-913 is currently in a Phase 1b study being conducted in the U.S.
CRB-601 is currently in a Phase 1 clinical trial being conducted in the U.S. and U.K.
Even if our initial trials are successful, we will be required to conduct additional trials to establish the safety and efficacy of our drug candidates before marketing application can be filed with the FDA for marketing approval of any of our drug candidates.
We are not permitted to market any of our drug candidates as prescription pharmaceutical products in the U.S. until we receive approval of a marketing application from the FDA or in foreign markets until we receive the requisite approval from comparable regulatory authorities in such countries.
In the U.S., the FDA generally requires the completion of pre-clinical and clinical trials of each drug to establish its safety and efficacy and extensive pharmaceutical development to ensure its quality before a marketing application is approved.
Of the large number of drugs in development, only a small percentage result in the submission of a marketing application to the FDA and even fewer are eventually approved for commercialization.
We have never submitted marketing application to the FDA or any comparable applications to other regulatory authorities.
Receipt of necessary regulatory approval is subject to a number of risks, including the following: • pre-clinical testing may not yield results that justify progressing to clinical testing; • the FDA or comparable foreign regulatory authorities or institutional review boards, or IRBs, may disagree with the design or implementation of our clinical trials; • we may not be able to provide acceptable evidence of the safety and efficacy of our drug candidates; • the results of our clinical trials may not be satisfactory or may not meet the level of statistical or clinical significance required by the FDA, EMA, MHRA or other comparable foreign regulatory authorities for marketing approval; • the dosing of our drug candidates in a particular clinical trial may not be at an optimal level; • patients in our clinical trials may suffer adverse effects for reasons that may or may not be related to our drug candidates; • the data collected from clinical trials may not be sufficient to support the submission of an NDA, BLA, or other submission or to obtain regulatory approval in the U.S. or elsewhere (collectively, “marketing application”); • the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; • the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval; and • the FDA or comparable foreign regulatory authorities may decide that the clinical trial endpoints we have chosen, the statistical analysis plans that we use, or any other parameter that we rely on to show the safety and efficacy of our drugs, are not parameters that can be used to support approval of our products.
These terminations, if they withstand legal challenges, may significantly delay and impede our interactions with the FDA.
Although drug candidates can take various paths, generally if Phase 1 test results are satisfactory and the FDA gives its approval, we can begin Phase 2 clinical tests.
Once clinical testing is completed and a marketing application is filed with the FDA, it may take more than a year to receive FDA approval.
As product candidates proceed through pre-clinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results.
Our marketing applications must include information about the chemistry and physical characteristics of our products, and we must demonstrate that we have a reliable process for manufacturing the products in commercial quantities in accordance with FDA’s current cGMP requirements.
If the FDA concludes a REMS is needed, the sponsor of the marketing application must submit a proposed REMS; the FDA will not approve the marketing application without an approved REMS, if required.
Orphan drug designation must be requested before submitting a marketing application.
Our collaboration partners are currently conducting and may intend in the future to conduct clinical trials outside the U.S., particularly in China where CSPC is conducting their own clinical trials.
As of December 31, 2025, we had 36 full-time employees.
In addition, the loss of the services of certain key employees would adversely impact our business prospects.
Our operations and performance depend, in part, on global and regional economic and geopolitical conditions, given our current third-party license agreement with CSPC, which is headquartered in China, and our reliance on global suppliers.
(CFIUS); • tariffs, including the announced tariffs on foreign goods; and • intergovernmental conflicts or actions, such as armed conflict, trade wars, and acts of terrorism or war.
Further, with rising international trade tensions or sanctions, our business may be adversely affected following new or increased tariffs.
In 2025, the United States announced tariffs on all foreign goods and individualized higher reciprocal tariffs on goods imported from certain countries.
Tariffs could result in increased global clinical trial costs as a result of international transportation of clinical drug supplies, as well as the costs of materials and products imported into the U.S.
Tariffs, trade restrictions or sanctions imposed by the U.S. or other countries could increase the prices of our and our collaboration partners’ drug products, affect our and our collaboration partners’ ability to commercialize such drug products, or create adverse tax consequences in the U.S. or other countries.
As a result, changes in international trade policy, changes in trade agreements and the imposition of tariffs or sanctions by the U.S. or other countries could materially adversely affect our results of operations and financial condition.
As of December 31, 2025, we had outstanding options to purchase an aggregate of 1,386,020 shares of our common stock at a weighted average exercise price of $37.40 per share, 498,543 shares of common stock issuable upon the vesting of restricted stock units, pre-funded warrants to purchase 1,025,000 shares of our common stock at an exercise price of $0.0001 per share and warrants to purchase an aggregate of 2,873 shares of our common stock at a weighted average exercise price of $208.80 per share.

and 6 more.

Gone since FY2024

RISK FACTORS An investment in our common stock is speculative and illiquid and involves a high degree of risk including the risk of a loss of your entire investment.
If any of the following risks actually materialize, our business, financial condition and/or operations could suffer.
In such event, the value of our common stock could decline, and you could lose all or a substantial portion of the money that you pay for our common stock.
All our product candidates that we do not intend to out-license are in the discovery stage, pre-clinical, or clinical development stage.
We must complete clinical studies and other development activity and receive regulatory approval of an NDA or BLA before commercial sales of a product can commence.
Our net loss was approximately $40.2 million and $44.6 million, for the years ended December 31, 2024 and 2023, respectively.
As of December 31, 2024, we had an accumulated deficit of approximately $476.9 million.
As of December 31, 2024, we held cash, cash equivalents, and investments of approximately $149.1 million.
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”).
For the year ended December 31, 2024, we have sold an aggregate of 2,484,517 shares of common stock for net proceeds of approximately $91.4 million under the Open Market Sale Agreement.
As of December 31, 2024, approximately $76.4 million is available for issuance and sale under the 2024 Open Market Offering.
On January 31, 2024, we entered into an underwriting agreement with Jefferies, as representative (the “Representative”) of the several underwriters (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 ("January 2024 Public Offering").
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 $94.5 million and net proceeds of $88.6 million after deducting underwriting discounts and commissions and other offering expenses payable by us.
CRB-701 is currently in a Phase 1 dose expansion clinical trial being conducted in China by CSPC (referred to herein as the China study) and a corresponding Phase 1 dose optimization clinical trial in the U.S. and U.K. conducted by us (referred to herein as the Western study).
We are also planning to expand the Western study by adding additional clinical sites in Europe during 2025.
CRB-601 is currently in a Phase 1 clinical trial being conducted in the U.S. with expansion planned in 2025 into the U.K.
We have completed initial pre-clinical testing for CRB-913 and expect to commence a Phase 1 clinical trial in the first quarter of 2025.
Even if our initial trials are successful, we will be required to conduct additional trials to establish the safety and efficacy of our drug candidates before an NDA or BLA can be filed with the FDA for marketing approval of any of our drug candidates.
We are not permitted to market any of our drug candidates as prescription pharmaceutical products in the U.S. until we receive approval of an NDA or BLA from the FDA or in foreign markets until we receive the requisite approval from comparable regulatory authorities in such countries.
In the U.S., the FDA generally requires the completion of pre-clinical and clinical trials of each drug to establish its safety and efficacy and extensive pharmaceutical development to ensure its quality before an NDA or BLA is approved.
Of the large number of drugs in development, only a small percentage result in the submission of an NDA or BLA to the FDA and even fewer are eventually approved for commercialization.
We have never submitted an NDA or BLA to the FDA or any comparable applications to other regulatory authorities.
Receipt of necessary regulatory approval is subject to a number of risks, including the following: • pre-clinical testing may not yield results that justify progressing to clinical testing; • the FDA or comparable foreign regulatory authorities or institutional review boards, or IRBs, may disagree with the design or implementation of our clinical trials; • we may not be able to provide acceptable evidence of the safety and efficacy of our drug candidates; • the results of our clinical trials may not be satisfactory or may not meet the level of statistical or clinical significance required by the FDA, EMA, MHRA or other comparable foreign regulatory authorities for marketing approval; • the dosing of our drug candidates in a particular clinical trial may not be at an optimal level; • patients in our clinical trials may suffer adverse effects for reasons that may or may not be related to our drug candidates; • the data collected from clinical trials may not be sufficient to support the submission of an NDA, BLA, or other submission or to obtain regulatory approval in the U.S. or elsewhere; • the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; • the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval; and • the FDA or comparable foreign regulatory authorities may decide that the clinical trial endpoints we have chosen, the statistical analysis plans that we use, or any other parameter that we rely on to show the safety and efficacy of our drugs, are not parameters that can be used to support approval of our products.
These terminations, if they withstand legal challenges, may significantly delay and impede our interactions with FDA.
If Phase 1 test results are satisfactory and the FDA gives its approval, we can begin Phase 2 clinical tests.
Once clinical testing is completed and an NDA or BLA is filed with the FDA, it may take more than a year to receive FDA approval.
As product candidates proceed through preclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results.
Our BLAs must include information about the chemistry and physical characteristics of our products, and we must demonstrate that we have a reliable process for manufacturing the products in commercial quantities in accordance with FDA’s current cGMP requirements.
If the FDA concludes a REMS is needed, the sponsor of the NDA or BLA must submit a proposed REMS; the FDA will not approve the NDA or BLA without an approved REMS, if required.
Orphan drug designation must be requested before submitting an NDA or BLA.
Our collaboration partners are currently conducting and may intend in the future to conduct clinical trials outside the U.S., particularly in China where CSPC is conducting a Phase 1 trial.
As of December 31, 2024, we had 28 full-time employees.
In addition, the loss of the services of certain key employees, including Yuval Cohen, our Chief Executive Officer, Sean Moran, our Chief Financial Officer, and Dominic Smethurst, our Chief Medical Officer, would adversely impact our business prospects.
In particular, we believe that the loss of the services of Yuval Cohen, Ph.D., our Chief Executive Officer, Sean Moran, C.P.A., M.B.A., our Chief Financial Officer, and Dominic Smethurst, MA MRCP, our Chief Medical Officer, would have a material adverse effect on our business.
Our operations and performance depend, in part, on global and regional economic and geopolitical conditions, given our current third-party license agreement with CSPC, which is headquartered in China.
(CFIUS); and • intergovernmental conflicts or actions, such as armed conflict, trade wars, retaliatory tariffs, and acts of terrorism or war.
As of December 31, 2024, we had outstanding options to purchase an aggregate of 723,153 shares of our common stock at a weighted average exercise price of $62.95 per share, 259,488 shares of common stock issuable upon the vesting of restricted stock units, and warrants to purchase an aggregate of 36,207 shares of our common stock at a weighted average exercise price of $381.14 per share.
We continue to examine the impact this tax reform legislation may have on our business.

and 1 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

Watch CRBP. Know when insiders buy.

One email the day a filing lands. Free.