Shares of little-known Corbus Pharmaceuticals (NASDAQ:CRBP) are absolutely skyrocketing today. At the time of writing, CRBP stock is up more than 300%, as investors price in a key announcement from the company. Earlier today, Corbus announced that its next-generation antibody drug (CRB-701) showed strong safety and efficacy in a first-in-human study on its effects on cervical cancer tumors. This drug conjugate is one of three key drugs that are currently in clinical trial phases but has clearly moved up the ...

Q3W schedule of CRB-701 (SYS6002) demonstrates a 43% ORR and 71% DCR at predicted therapeutically relevant dosesAll assessable nectin-4 positive study participants with mUC and cervical cancer treated at or above this dose demonstrated some level of disease controlNo dose limiting toxicities (DLTs) have been observed to-date up to 3.6 mg/kg (cohort 6) with further escalation at 4.5 mg/kg ongoingNo cases of peripheral neuropathy or skin rash have been observed to dateCohort 6 is the first cohort selected for ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 or For the transition period from________ to_________. Corbus Pharmaceuticals Holdings, Inc. (Exact name of registrant as specified in its charter) (Former Name, Former Address and Former Fiscal Year if Changed Since Last Report): N/A Title of Each Class Exchange on Which Registered TradingSymbolNameofEach Large accelerated filer ☐ Accelerated filer ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from________ to_________. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 500 River Ridge Drive Norwood, MA ...

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |----------------------------------------------------------------------------------------------|---------------------------------------------| | For the transition period | from________ to_________. | | Commission File 001-37348 | Number: | | Corbus Pharmaceuticals Holdings, Inc. (Exact name of registrant as specified | in its charter) | | Delaware | 46-4348039 | | (State or other jurisdiction of incorpor ...

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval for our drug candidates, restrict or regulate post-approval activities and affect our ability to profitably sell our drug candidates. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Title of Each Class Trading Symbol Name of Each Exchange on Which Registered Common Stock, par value $0.0001 per share CRBP Nasdaq Global Market FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from________ to_________. C ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | |---------------------------------------------------------------------------------------------------| | For the transition period from________ to_________. | | Commission File Number: 001-37348 | ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from________ to_________. | --- | --- | |---------------------------------------------------------------------------------------------|----------------------------------------- ...

Research and Development - Corbus Pharmaceuticals' research and development expenses were approximately $36.4 million and $98.3 million for the years ended December 31, 2021, and 2020, respectively[38]. - The company plans to submit an IND for CRB-601, an anti-αvβ8 monoclonal antibody, to the FDA in the first half of 2023[16]. - CRB-601 demonstrated dose-related effects on tumor volume and weight in preclinical models, indicating its potential as a cancer treatment[26]. - The company does not plan to conduct additional clinical studies for Lenabasum, which failed to meet primary endpoints in previous trials, and will seek licensing partners for future development[18]. - Corbus is developing second-generation cannabinoid receptor type 1 (CB1) inverse agonists that have shown weight loss effects in animal models of diet-induced obesity[17]. - The company is focused on expanding its immuno-oncology pipeline through strategic partnerships and acquisitions[21]. - Lenabasum selectively activates cannabinoid receptor type 2 (CB2) and has shown potential to reduce inflammation and limit fibrosis without immunosuppression[37]. - The intellectual property for CRB-602, an anti-αvβ6/αvβ8 monoclonal antibody for fibrotic diseases, was in-licensed from Milky Way BioPharma[31]. - The company aims to develop therapies targeting immune-resistant cancers, focusing on blocking immune suppression mechanisms[22]. - The company is currently conducting pre-clinical testing for CRB-601 and has advanced its product candidate lenabasum to a phase 3 study, which did not meet its primary endpoint in June 2021[119]. Intellectual Property - Corbus has filed patent applications for lenabasum and its formulations, with potential patent expirations ranging from 2031 to 2040[42]. - The Company has received U.S. Patent No. 9,801,849 for lenabasum, providing exclusivity for treating inflammatory diseases until February 12, 2034[46]. - U.S. Patent No. 9,820,964 was issued for lenabasum's use in treating fibrotic diseases, including systemic sclerosis and cystic fibrosis, with protection until February 12, 2034[47]. - Lenabasum has been granted Orphan Drug Designation for cystic fibrosis, dermatomyositis, and systemic sclerosis, providing seven years of market exclusivity in the U.S. and ten years in Europe and Japan[49]. - The Company entered into an exclusive license agreement with Jenrin Discovery for cannabinoid compounds, including CRB-4001, with patent protection until July 2033[51]. - The UCSF License Agreement grants the Company exclusive rights to develop humanized antibodies against integrin αvβ8, with potential patent expiration in 2041[52]. - The company has in-licensed intellectual property from Jenrin and The Regents, which is crucial for developing drug candidates and may involve various obligations such as milestone payments and royalties[205][207]. - Protecting intellectual property rights is complex and costly, with uncertainties surrounding the enforceability of patents and potential challenges from third parties[199]. - The company relies on trade secrets for technology protection, but maintaining confidentiality is difficult and may not provide sufficient competitive advantage[201]. - Failure to secure patent or trade secret protection could impair the company's ability to compete and generate revenues[202]. Financial Performance - The company has incurred net losses of approximately $45.64 million and $111.27 million for the years ended December 31, 2021, and December 31, 2020, respectively, with an accumulated deficit of approximately $349.7 million as of December 31, 2021[104]. - As of December 31, 2021, the company held cash, cash equivalents, and investments of approximately $97.6 million, which is expected to fund operations into 2024 based on planned expenditures[107][110]. - The company has not generated any revenue from its drug candidates to date and expects to incur substantial expenses without corresponding revenues until regulatory approval is obtained[104][105]. - The company expects to continue incurring substantial losses for the foreseeable future, with uncertainty regarding achieving or sustaining profitability[105][106]. - The company may seek additional capital through private and public equity offerings, debt financings, and strategic collaborations, which could result in dilution for existing stockholders[111][112]. - The Loan and Security Agreement with K2 HealthVentures allows for term loans up to $50 million, secured by a lien covering substantially all personal property[108][113]. Regulatory Environment - The company must navigate extensive regulatory requirements in both the U.S. and Europe for marketing its products, including obtaining marketing authorizations[75][76]. - The centralized procedure for product approval in the EU is mandatory for biotechnological products and optional for new active substances[78]. - The company is subject to ongoing regulation by the FDA and other authorities post-approval, including monitoring and reporting adverse experiences[81]. - The company faces significant uncertainty regarding coverage and reimbursement from third-party payers, which is critical for successful commercialization[87]. - The federal healthcare program anti-kickback law and false claims laws impose strict regulations that the company must comply with to avoid penalties[83]. - The company’s ability to market its products in foreign countries may be impacted by varying drug pricing and reimbursement requirements[91]. - Legislative changes in the U.S. healthcare system may increase the difficulty and cost of obtaining marketing approval for drug candidates[160]. - The company may face challenges in obtaining adequate reimbursement for its products, which could impact profitability[196]. Manufacturing and Supply Chain - The company relies on third-party contract manufacturers for the production of drugs for pre-clinical and clinical studies[58]. - The company relies on a single contract supplier for manufacturing monoclonal antibodies, which poses risks if the supplier fails to meet regulatory requirements[175]. - The company does not have the capability to manufacture its drug candidates and relies on contract manufacturers, which could lead to delays or quality issues[174]. - Any manufacturing problems or loss of a contract manufacturer could disrupt operations and result in lost sales[179]. - The company may face significant interruptions in the supply of drug candidates if third-party manufacturers encounter difficulties[177]. - The company faces risks in scaling up manufacturing to commercial levels, which may lead to delays in regulatory approval and commercialization[181]. - There are significant concerns regarding cost overruns and technical issues in the manufacturing process, which could adversely affect financial results and growth prospects[182]. Competition and Market Dynamics - The biotechnology industry is characterized by rapid innovation and strong competition, with notable competitors targeting the TGFβ pathway in cancer[59][60]. - The company faces intense competition from biotechnology and pharmaceutical companies with greater resources, which could impact its operating results[157]. - The commercial success of drug candidates will depend on acceptance by the medical community, which is influenced by factors such as clinical safety, efficacy, and pricing[143]. - If approved, the company may still face limitations on marketing and commercialization, including potential restrictions on indicated uses or post-approval commitments[146]. Risks and Uncertainties - The company faces risks related to the COVID-19 pandemic, which could adversely affect clinical trial operations and overall business performance[120][124]. - Drug development is a lengthy and expensive process, with a high uncertainty of outcomes, and only a small percentage of drugs in development result in a New Drug Application (NDA) submission to the FDA[132]. - The company has never submitted an NDA to the FDA or any comparable applications to other regulatory authorities, which poses a significant risk to its business[132]. - Regulatory approval is subject to numerous risks, including the potential for pre-clinical testing to yield unsatisfactory results and the possibility of the FDA requiring additional trials[134]. - The company relies on third-party contract research organizations (CROs) for expertise in regulatory approval processes, indicating limited internal experience[136]. - The drug testing process can take many years, and even if initial trials are successful, further trials are required to establish safety and efficacy before an NDA can be filed[140]. - Ongoing regulatory obligations and continued review may result in significant additional expenses for the company[147]. - The company may face administrative or judicial sanctions if unknown problems with a product are discovered, which could inhibit commercialization efforts[152]. - Adverse regulatory actions can lead to increased product liability exposure and potential claims against the company[153]. - The company may experience increased product development costs due to delays in testing or regulatory approval, which could harm commercial prospects[191]. Legal and Compliance Issues - The company may face potential liability for damages if any patent-related legal actions are taken against it, which could hinder its ability to market product candidates[209]. - The pharmaceutical industry is characterized by frequent litigation regarding patent rights, making it challenging to identify relevant third-party patents[208]. - The company may need to obtain licenses for certain patents to research, develop, or commercialize its product candidates, and there is no guarantee that such licenses would be available on commercially reasonable terms[209]. - The company could be forced to rebrand its products if trademark applications are successfully challenged, resulting in loss of brand recognition[203]. - Future license agreements are expected to impose various obligations on the company, which could affect its product discovery and development efforts[205][207]. - The company may be subject to claims regarding the wrongful hiring of employees from competitors or misuse of confidential information[213]. - The company has not faced any claims of infringement yet, but the potential for such claims exists, which could impact its operations[209]. - The company must navigate the complexities of patent validity challenges, which require clear and convincing evidence to prevail in court[210][211].