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

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 [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 or [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to ________ ...

Financial Data and Key Metrics Changes - The company ended the quarter with $46.6 million in cash and cash equivalents, maintaining guidance to fund operations into the fourth quarter of 2020 with remaining milestone payments of $7.5 million from the Cystic Fibrosis Foundation Award [33] Business Line Data and Key Metrics Changes - The RESOLVE 1 Phase 3 study in systemic sclerosis is on schedule, with topline data expected in summer 2020, followed by data from the Phase 2b lenabasum study in cystic fibrosis [8][9] - Enrollment in the Phase 3 DETERMINE study in dermatomyositis is about 80%, with completion anticipated in the third quarter of 2020 [16] Market Data and Key Metrics Changes - A survey conducted with 100 U.S.-based rheumatologists revealed that nearly half of their systemic sclerosis patients suffer from the diffuse cutaneous form of the disease, highlighting the unmet need [22][24] - Approximately 50% of respondents were familiar with the cannabinoid receptor Type 2 as a potential treatment mechanism, and about 30% were aware of lenabasum as a future treatment [25] Company Strategy and Development Direction - The company is focused on preparing for NDA submission and commercialization following FDA approval, with multiple data readouts and catalysts anticipated in the coming months [9][34] - A disease education campaign is underway to provide rheumatologists with relevant scientific information on systemic sclerosis, emphasizing the unmet need and potential treatments [28][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the second half of the year, citing multiple data readouts as the most significant period since the company's founding [34] - The company does not anticipate significant delays in data collection due to COVID-19, with remote data monitoring procedures in place [10][41] Other Important Information - The Phase 1 study of CRB-4001 is on schedule to start in the third quarter of 2020, with additional work being done to expand the pipeline [18][20] - The company has implemented new remote working procedures and data monitoring to ensure the safety and integrity of ongoing clinical trials during the pandemic [11][12] Q&A Session Summary Question: Data collection in the RESOLVE 1 study - Management confirmed that 99% of patients have completed dosing, with data collection ongoing for the 28-day safety follow-up [38][41] Question: Relationship between mRSS and CRISS score - Management stated that the minimal important difference for mRSS will be determined at the end of the study, with no speculation on current values [47][50] Question: Enrollment in the open-label extension - Management clarified that eligibility for the open-label extension includes patients who completed dosing in the double-blind study, with over 300 patients currently enrolled [69] Question: Timing of data results - Management indicated that topline data for cystic fibrosis will be released approximately a month after the systemic sclerosis data [71] Question: Website information collection - The website is directed at rheumatologists, not patients, and aims to build a database of interested physicians while providing disease education [55]

Clinical Development - Lenabasum is currently in Phase 3 studies for systemic sclerosis (SSc) with 365 patients enrolled and topline data expected in summer 2020[25]. - The Phase 2b study for cystic fibrosis (CF) has completed enrollment of 426 patients, with topline data also expected in summer 2020[42]. - The ongoing Phase 3 study for dermatomyositis (DM) is expected to enroll approximately 150 subjects, with a primary efficacy outcome based on the Total Improvement Score[48]. - The Phase 2 clinical trial for systemic lupus erythematosus (SLE) is expected to enroll 100 adult patients and report top line data in 2020[56][57]. - Lenabasum treatment showed a mean improvement of 9.3 points in the CDASI activity score compared to a 3.7 points reduction for placebo, with a p-value of 0.04[52]. - Lenabasum has demonstrated potent anti-inflammatory effects in a human model, enhancing bacterial clearance and inhibiting neutrophil infiltration[69][75]. - Lenabasum is designed to transition the innate immune response from the activation phase to the resolution phase, potentially addressing chronic inflammatory diseases[62]. - Lenabasum is proposed as a novel drug that resolves inflammation and halts fibrosis without immunosuppression, potentially addressing a significant unmet medical need in chronic inflammatory diseases[110]. - Lenabasum is being developed for autoimmune disorders with a unique mode of action, potentially resolving inflammation and halting fibrosis without immunosuppression[117]. Market Opportunity - The market opportunity for lenabasum includes serious inflammatory and fibrotic diseases such as systemic sclerosis, systemic lupus erythematosus, and nonalcoholic steatohepatitis[78]. - Approximately 200,000 people in the U.S., Europe, and Japan are affected by systemic sclerosis (SSc), with a median disease duration of 7.1 years from symptom onset to death[80][82]. - Approximately 80,000 individuals in the U.S., Europe, and Japan suffer from dermatomyositis (DM), which typically affects adults aged 50-60 years[85]. - The current median life expectancy for cystic fibrosis (CF) patients is about 40 years, with 30,000 Americans and 70,000 people in total suffering from the disease[96]. - An effective anti-inflammatory and anti-fibrotic drug for systemic sclerosis (SSc) is believed to address a significant unmet medical need, particularly if it is orally administered and not immunosuppressive[84]. - An effective drug that controls inflammation in DM is believed to address a significant unmet medical need, especially if it is orally administered and not immunosuppressive[89]. Financials and Funding - The company incurred approximately $88.6 million and $48.6 million in research and development expenses for the years ended December 31, 2019, and 2018, respectively[121]. - The company expects to continue incurring substantial losses for the foreseeable future due to ongoing research and development expenses related to its drug candidates[183]. - The company held cash and cash equivalents of approximately $31.7 million as of December 31, 2019, and anticipates that combined with expected proceeds from offerings, it will meet operating and capital requirements into the fourth quarter of 2020[191]. - The company has received a development award of up to $25 million from the Cystic Fibrosis Foundation to support a Phase 2b clinical trial of lenabasum, of which $17.5 million has been received to date[188]. - The company completed an underwritten public offering in February 2020, raising gross proceeds of $46 million[190]. - The company has not generated any revenue from its drug candidates to date and relies heavily on the successful development and commercialization of lenabasum[196]. Regulatory and Approval Challenges - Lenabasum has received Orphan Drug Designation and Fast Track Status from the FDA for SSc and CF, indicating its potential for addressing unmet medical needs[26]. - The regulatory approval process for lenabasum requires substantial time and financial resources, with compliance to various regulations being critical[134][135]. - The FDA may impose significant difficulties or costs in obtaining approvals, including the requirement for risk evaluation and mitigation strategies (REMS) for drug safety[145]. - The company must obtain separate state registrations and licenses for handling controlled substances, which could further delay clinical studies and product distribution[163]. - The company relies on third-party contract research organizations for regulatory approval processes, indicating limited in-house experience in this area[209]. - Regulatory approval is subject to various risks, including disagreements with regulatory authorities on trial design and insufficient evidence of safety and efficacy[207]. Strategic Collaborations and Partnerships - The company entered into a strategic collaboration with Kaken Pharmaceutical Co., Ltd., receiving an upfront payment of $27 million and potential additional payments of up to $173 million upon achieving certain milestones[189]. - The company plans to commercialize lenabasum in the U.S. independently while exploring partnerships in Europe[120]. Risks and Uncertainties - The company faces significant risks related to its limited operating history and the speculative nature of pharmaceutical product development[178]. - The ongoing impact of COVID-19 in regions like China and Italy could disrupt the company's business operations and clinical trials, potentially delaying regulatory approvals[199]. - Delays in preclinical and clinical trials could adversely affect the timeline for data readouts and regulatory filings, impacting the ability to commercialize product candidates[202]. - Even with regulatory approval, the commercial success of drug candidates depends on acceptance by the medical community and may be limited by factors such as pricing and competition[215]. - The company anticipates pricing pressures in the pharmaceutical industry due to managed healthcare trends and legislative proposals, which could adversely affect operations[166].

Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) Q4 2019 Earnings Conference Call March 12, 2020 8:30 AM ET Company Participants Ted Jenkins - Senior Director, Investor Relations and Corporate Communications Yuval Cohen - Chief Executive Officer Barbara White - Chief Medical Officer and Head, Research Craig Millian - Chief Commercial Officer Conference Call Participants Brian Abrahams - RBC Capital Markets Maury Raycroft - Jefferies Leland Gershell - Oppenheimer Operator Good morning and welcome to the C ...

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

Financial Data and Key Metrics Changes - Corbus Pharmaceuticals ended Q3 2019 with approximately $55 million in cash, which is expected to be sufficient to support operations through key data readouts and into Q3 2020 [18] Business Line Data and Key Metrics Changes - The RESOLVE-1 global Phase 3 study of lenabasum in systemic sclerosis is fully enrolled with 365 patients dosed, with top-line data expected next summer [7] - The DETERMINE global Phase 3 study of lenabasum in dermatomyositis is actively enrolling subjects, with expectations to complete enrollment in 2020 and top-line results in 2021 [8] - The 415 patient Phase 2b study in cystic fibrosis is ongoing, with top-line data expected in summer 2020 [10] Market Data and Key Metrics Changes - Market research indicates a strong need for new anti-inflammatory treatments in cystic fibrosis, particularly for patients with established lung disease who continue to experience exacerbations [16] Company Strategy and Development Direction - The company is focused on preparing for the commercial launch of lenabasum, building a commercial leadership team, and establishing market insights [14] - Corbus aims to explore additional partnerships abroad, particularly in Asia, to increase global reach [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding upcoming data from Phase 3 studies and the potential for lenabasum to reshape treatment paradigms for inflammatory and fibrotic diseases [6][18] - The company is preparing for a successful launch and is actively engaging with patients and physicians to understand the unmet needs in systemic sclerosis and cystic fibrosis [15][16] Other Important Information - The second drug in the pipeline, CRB-4001, is targeting NASH with fibrosis, with a Phase 1 safety study scheduled for readout in 2020 [11] - The company highlighted eight promising compounds at their R&D Day, which are progressing through candidate selection [11] Q&A Session Summary Question: Key learnings from systemic sclerosis patients on treatment and expectations for ACR data - Management expects to see a favorable long-term safety profile and durable efficacy data in the upcoming ACR presentation [23] Question: Impact of recent changes in standard of care on the Phase 2b study in cystic fibrosis - Management believes lenabasum will offer treatment benefits on top of existing standard care treatments, and they are prepared for statistical sensitivity analysis [25] Question: Updates on formulation work for CRB-4001 and timelines for PET data - Management is optimistic about the formulation for CRB-4001 and expects to have readouts from the Phase 1 study in 2020, but timelines for PET data remain uncertain [30] Question: Focus areas for ACR updates and competitive landscape - Management highlighted the importance of safety and efficacy data in their presentations at ACR, and they expect to be the first to seek approval for systemic sclerosis treatments [36] Question: Progress on preclinical CB programs and potential partnerships - Management indicated that they are making progress with their internal compounds and anticipate moving forward with candidate selection in the coming months [38]

Pioneering transformative medicines that target the endocannabinoid system NASDAQ: CRBP @corbuspharma www.corbuspharma.com TM Forward-Looking Statements This presentation contains certain forward-looking statements, including those relating to the Company's product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predict ...

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 Emerging growth company [X] FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period September 30, 2019 or [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period f ...

Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) Q2 2019 Earnings Conference Call August 8, 2019 8:30 AM ET Company Participants Ted Jenkins - Senior Director, Investor Relations & Corporate Communications Yuval Cohen - Chief Executive Officer Barbara White - Chief Medical Officer Craig Millian - Chief Commercial Officer. Conference Call Participants Brian Abrahams - RBC Liisa Bayko - JMP Securities Maury Raycroft - Jefferies Ted Tenthoff - Piper Jaffray George Zavoico - B. Riley FBR Operator Good mornin ...