☒ 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 ...

Financial Performance - Revenue from awards for the three months ended June 30, 2022, was $136,558, compared to $784,382 for the same period in 2021, indicating a decrease of about 82.6%[13] - The net loss for the three months ended June 30, 2022, was $13.25 million, compared to a net loss of $17.14 million for the same period in 2021, reflecting an improvement of about 22.1%[13] - The company reported a basic and diluted net loss per share of $0.11 for the three months ended June 30, 2022, compared to $0.15 for the same period in 2021[13] - The net loss for the second quarter of 2022 was $13,248,888, compared to a net loss of $17,138,376 for the same period in 2021, reflecting a decrease of approximately 22%[62] - For the three months ended June 30, 2022, the net loss was approximately $13.25 million, compared to a net loss of $17.14 million for the same period in 2021, representing a decrease of 22%[139] - For the six months ended June 30, 2022, the company recognized $0 in revenue, compared to $784,000 in revenue for the same period in 2021[155] Expenses and Liabilities - Total operating expenses for the three months ended June 30, 2022, were $12.34 million, down from $16.84 million in the same period of 2021, a reduction of approximately 26.5%[13] - The company incurred $5 million in litigation settlement expenses during the three months ended June 30, 2022[13] - Research and development expenses for the three months ended June 30, 2022, totaled approximately $2.5 million, a decrease of $8.77 million from $11.27 million in the same period of 2021[149] - General and administrative expenses for the three months ended June 30, 2022, were approximately $4.84 million, down from $5.57 million in the same period of 2021[151] - Research and development expenses for the six months ended June 30, 2022, were approximately $5.79 million, a decrease of $16.2 million from $21.99 million in the same period of 2021[156] - Interest expense for the three and six months ended June 30, 2022, was approximately $698,000 and $1,382,000, respectively[94] Assets and Equity - Total assets decreased from $107.73 million on December 31, 2021, to $82.07 million as of June 30, 2022, representing a decline of approximately 23.9%[10] - Total stockholders' equity decreased from $61.16 million on December 31, 2021, to $49.47 million as of June 30, 2022, a decline of approximately 19.1%[16] - Cash and cash equivalents increased slightly from $25.01 million on December 31, 2021, to $25.77 million as of June 30, 2022, an increase of approximately 3.1%[10] - Current liabilities decreased from $17.01 million on December 31, 2021, to $15.63 million as of June 30, 2022, a decline of about 8.1%[10] - As of June 30, 2022, total current assets were approximately $75.24 million, with current liabilities of approximately $15.63 million, resulting in working capital of approximately $59.61 million[162] Cash Flow - For the six months ended June 30, 2022, net cash used in operating activities was $22,844,404, a reduction from $39,338,076 in the same period of 2021[22] - Cash flows from investing activities resulted in a net cash provided of $24,265,670 for the six months ended June 30, 2022, compared to a net cash used of $70,523,241 in the same period of 2021[22] - Net cash used in operating activities for the six months ended June 30, 2022, was approximately $22.84 million[163] - Cash provided by investing activities for the six months ended June 30, 2022, totaled approximately $24.27 million, primarily related to sales and purchases of marketable securities[164] Future Outlook and Financing - The company anticipates ongoing operating losses due to costs related to research funding and development of product candidates[28] - The company will need to raise significant additional capital to fund operations and product candidate development, potentially through equity sales or debt financing[168] - Future financing availability will depend on market conditions and the progress of clinical development programs[169] - The company expects cash, cash equivalents, and marketable securities of approximately $73.3 million will be sufficient to meet operating and capital requirements into Q1 2024[167] Research and Development - The company plans to expand its pipeline in immuno-oncology through internal efforts and business development, focusing on immune modulators for various disease states[25] - The company incurred research and development expenses that are expensed as incurred, with no material adjustments to prior period estimates for clinical trials in 2022[49] - The company has not experienced significant changes in estimates of accrued research and development expenses following each reporting period[184] Legal and Settlement - The company made a $5 million settlement payment to Venn Therapeutics on May 26, 2022, resolving all claims against it[85] - Litigation settlement expense for the three months ended June 30, 2022, totaled $5 million due to a settlement with Venn Therapeutics, LLC[152] Stock and Shares - The weighted average number of common shares outstanding increased from 116.36 million in the second quarter of 2021 to 125.26 million in the second quarter of 2022[13] - As of June 30, 2022, the Company had 125,268,381 shares of common stock issued and outstanding, compared to 125,230,881 shares as of December 31, 2021[109] - The Company was authorized to sell up to $150,000,000 of shares under the August 2020 Sale Agreement, but did not sell any shares during the three and six months ended June 30, 2022[110] Investments and Securities - The Company reported total investments of $47,652,000 as of June 30, 2022, with a fair value of $47,533,000, reflecting a gross unrealized loss of $119,000[68] - The total fair value of financial assets as of June 30, 2022, was $69,316,000, with derivative liabilities amounting to $134,000[70] - The Company has classified all marketable debt securities as available-for-sale, with unrealized gains and losses reported as accumulated other comprehensive gain or loss[37] Risk Factors - The company continues to monitor the impact of the COVID-19 pandemic on its business and operations, indicating potential risks to future performance[27] - There have been no material changes in risk factors since the last annual report[196]

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].

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 September 30, 2021 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 Corbus Pharmaceuticals Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 46-4348039 ...

Financial Performance - Revenue from awards and licenses for Q2 2021 was $136,558, down 52% from $286,346 in Q2 2020[15] - Total operating expenses decreased to $16,837,617 in Q2 2021, a reduction of 56% from $38,425,039 in Q2 2020[15] - The net loss for Q2 2021 was $17,138,376, compared to a net loss of $38,105,323 in Q2 2020, indicating a 55% improvement[15] - The company reported a basic and diluted net loss per share of $0.15 for Q2 2021, an improvement from $0.52 in Q2 2020[15] - The company had a total comprehensive loss of $17,115,065 for Q2 2021, compared to $38,105,323 in Q2 2020[15] - The net loss for the second quarter of 2021 was $33,203,544, a significant improvement from a net loss of $67,762,123 in the same period of 2020, representing a 51% reduction[27] - The net loss for the three months ended June 30, 2021, was $33,203,544, compared to a net loss of $17,138,376 for the same period in 2020, representing an increase of approximately 93%[73] - The net loss per share of common stock for the three months ended June 30, 2021, was $(0.28), compared to $(0.15) for the same period in 2020, reflecting a deterioration in per-share performance[73] - The company has an accumulated deficit of $337,296,882 as of June 30, 2021, highlighting ongoing financial challenges[32] - The company anticipates continued operating losses due to costs related to research funding and development of product candidates[32] Assets and Liabilities - Total current assets increased to $111,580,059 as of June 30, 2021, compared to $92,074,631 at December 31, 2020, representing a 21% increase[13] - Cash and cash equivalents decreased to $36,080,292 as of June 30, 2021, down 58% from $85,433,441 at December 31, 2020[13] - Total liabilities decreased to $43,649,938 as of June 30, 2021, down 23% from $57,020,006 at December 31, 2020[13] - The total assets increased to $120,609,139 as of June 30, 2021, compared to $102,294,931 at December 31, 2020, reflecting an 18% increase[13] - Total current liabilities were approximately $18,737,000, resulting in working capital of approximately $92,843,000 as of June 30, 2021[186] Cash Flow - Cash used in operating activities decreased to $39,338,076 in Q2 2021 from $54,208,282 in Q2 2020, indicating improved cash flow management[27] - Cash used in operating activities for the six months ended June 30, 2021 was approximately $39,338,000, which includes a net loss of approximately $33,204,000[187] - The company expects to have sufficient cash and marketable securities of approximately $106,452,000 to meet its operating and capital requirements for at least the next twelve months[32] - The company expects to have sufficient cash and equivalents of approximately $107,122,000 to meet operating and capital requirements into 2024, along with a final $2,500,000 milestone payment expected by the end of the second half of 2021[192] Research and Development - The company plans to expand its pipeline through internal efforts and business development, focusing on new medicines targeting inflammation and fibrosis[28] - Research and development expenses decreased to approximately $11,265,000 for the three months ended June 30, 2021, down from $30,686,000 in the same period of 2020, primarily due to lower clinical trial expenses[175] - The company has focused on research and development, including clinical studies for lenabasum and pre-clinical studies for other drug candidates[161] - The company expects to file INDs for CRB-601 and CRB-602 in late 2022 and early 2023, respectively[158] - Lenabasum is in Phase 2 study for systemic lupus erythematosus (SLE), with top line results expected by the end of 2021[155] Stock and Equity - The weighted average number of common shares outstanding increased to 116,364,131 in Q2 2021, compared to 73,885,548 in Q2 2020[15] - The company issued 50,000 and 838,600 shares of common stock upon the exercise of stock options during the three and six months ended June 30, 2021, respectively, generating proceeds of $50,000 and $944,800[129] - As of June 30, 2021, there were 18,476,829 stock options outstanding with a weighted average exercise price of $4.38[138] - The total fair value of options that were vested as of June 30, 2021, was $37,286,931, up from $31,198,928 in 2020[139] - The company has never paid dividends on its common stock and does not anticipate doing so in the foreseeable future[199] Debt and Financing - The company has a secured Loan and Security Agreement with K2 HealthVentures LLC for $50,000,000, with the first tranche of $20,000,000 received upon signing[92] - The interest rate on the K2 HealthVentures loan is variable, with a minimum of 8.5%, and the loan matures on August 1, 2024[92] - The total principal amount of the loan outstanding as of June 30, 2021, is $21,190,000, which includes a final payment of $1,190,000[95] - Future principal payments due under long-term debt total $21,190,000, with $3,093,344 due in 2022 and $9,835,341 due in 2023[99] - The company expects to incur significant operating losses and will need additional financing to support ongoing operations, with plans to seek funding through public or private equity or debt financings[167] License Agreements - The company has entered into a License Agreement with Jenrin Discovery, LLC, involving an upfront payment of $250,000 and potential milestone payments up to $18,400,000 for each compound developed[79][80] - Under the Milky Way License Agreement, the company paid an upfront fee of $500,000 and is obligated to pay up to $53,000,000 in milestone payments[81][82] - The UCSF License Agreement required a license issue fee of $1,500,000 and includes potential milestone payments totaling up to $153,000,000[83][84] - The company has a potential obligation to pay milestone payments totaling up to approximately $173,000,000 under the collaboration agreement with Kaken[103] Accounting and Compliance - The company is currently evaluating the potential impact of recently issued accounting standards on its consolidated financial statements and related disclosures[69] - The company recognizes stock-based compensation costs using the Black-Scholes option-pricing model, amortized over the vesting period, which is generally 48 months[199] - The company has recorded a valuation allowance equal to 100% of the deferred tax assets due to cumulative losses since inception, indicating no expectation of realizing these tax benefits[61] - The company was in compliance with financial and non-financial covenants of the Loan Agreement as of June 30, 2021[96]

Pipeline and Focus - Corbus Pharmaceuticals is expanding its therapeutic focus beyond the endocannabinoid system to include TGF-INTEGRIN biology[4, 6] - Lenabasum, a CB2 agonist, is in Phase 3 development for Dermatomyositis, with topline data expected in Q2 2021, and in Phase 2 for Lupus, with topline data expected in the second half of 2021[7, 14] - The company is developing second-generation CB1 inverse agonists for metabolic and fibrotic diseases[23] - Corbus is also pursuing a CB2 agonist immuno-oncology program targeting solid tumors[7, 41] - CRB-601, an anti-αvβ8 mAb, is being developed for solid tumors, and CRB-602, an anti-αvβ6/8 mAb, is in preclinical development for fibrosis, with Phase 1 trials for CRB-602 estimated to start by the end of 2022[8, 56] Lenabasum in Dermatomyositis - Dermatomyositis affects approximately 80,000 people in North America, EU, and Japan, and has a 30% mortality rate in 5 years[17, 18] - A Phase 2 study of Lenabasum in Dermatomyositis showed improvement in skin activity and biomarkers[18] - The Phase 3 trial in adults with Dermatomyositis has a primary endpoint of ACR & EULAR 2016 Total Improvement Score (TIS) at Week 28, with 176 participants[19] CB1 Inverse Agonists for Metabolic Diseases - Approximately 50% of the US population is obese, and obesity is estimated to rise to 85% by the end of the decade, leading to significant medical costs of ~$480 billion annually[24] - CB1 activation contributes to "Diabesity" by increasing appetite, fat production, insulin resistance, inflammation, and fibrosis, while decreasing insulin secretion and fat oxidation[26] - In a DIO model, the CB1 inverse agonist CRB-556 induced dose-dependent weight loss in obese mice and improved glucose tolerance and insulin sensitivity[34, 35] Financial Status - As of March 31, 2021, Corbus Pharmaceuticals had a cash balance of $125 million, with 125 million common shares outstanding (1401 million fully diluted)[58] - The company is funded through Q1 2024[6]

CORBUS PHARMACEUTICALS PIONEERING TRANSFORMATIVE MEDICINES THAT TARGET THE ENDOCANNABINOID SYSTEM NASDAQ: CRBP | corbuspharma.com | @corbuspharma ® | --- | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...