UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2020 ☐ 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 | --- | --- | --- | |---------------------------------------------------------------------------------------------------- ...

Financial Data and Key Metrics Changes - The company underwent a significant restructuring to reduce costs and extend its cash runway to $82 million, projected to last until mid-2022 [34] - The company reported disappointing top-line data from its Phase 3 study in systemic sclerosis and Phase 2b study in cystic fibrosis, with lenabasum not meeting its primary endpoints [8][16] Business Line Data and Key Metrics Changes - The Phase 3 study of lenabasum in systemic sclerosis did not meet its primary endpoint, but post-hoc analyses suggested potential clinical activity in patients on established immunosuppressants [16][20] - In the Phase 2b study for cystic fibrosis, lenabasum treatment was associated with a maximum reduction of pulmonary exacerbations by up to 62% in specific patient subsets [24] Market Data and Key Metrics Changes - The dermatomyositis market presents a significant opportunity with approximately 30,000 patients in the U.S. and a clear unmet need [11] - The company plans to shorten the duration of the Phase 3 DETERMINE study from one year to 28 weeks to align with competitive studies and accelerate topline data readouts [12][28] Company Strategy and Development Direction - The company aims to rebuild shareholder value through three concepts: demonstrating lenabasum's clinical activity, focusing on dermatomyositis as a value driver, and leveraging its pipeline beyond lenabasum [9][11][13] - The company is evaluating options for expanding its pipeline with external assets that complement its current capabilities [14] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges faced in recent trials but remains optimistic about the potential of lenabasum in specific indications [8][10] - The company is committed to collaborating with experts in systemic sclerosis and cystic fibrosis to explore future study designs and regulatory pathways [36][60] Other Important Information - The company has a promising preclinical program involving a novel family of CB2 agonists that may inhibit tumor cell growth [32] - The Chief Operating Officer has resigned, which may impact the company's leadership dynamics [35] Q&A Session Summary Question: Rationale behind shortening the dermatomyositis study - Management noted that the study duration was adjusted based on competitive landscape and preliminary data indicating that most improvements occur within the first six months [40][42] Question: Limitations observed with CRB-4001 - Management identified formulation challenges and concerns regarding blood-brain barrier penetration as key issues with CRB-4001, leading to a shift in focus to more promising compounds [46][48] Question: Regulatory path for systemic sclerosis trial - Management clarified that the recent Phase 3 study is not adequate for regulatory approval, and further studies will be necessary to support a new application [50][51] Question: Feedback from the cystic fibrosis community - Management indicated ongoing discussions with the cystic fibrosis community but emphasized that the failure to meet the primary endpoint limits the current trial's utility for approval [52] Question: Future development candidates for CB1 inverse agonists - Management plans to prioritize one promising compound for clinical development while keeping options open for others based on preclinical data [61]

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, 2020 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 ...

Pioneering transformative medicines that target the endocannabinoid system RESOLVE-1 Phase 3 Study of Lenabasum in Systemic Sclerosis NASDAQ: CRBP @corbuspharma © 2019 Corbus Pharmaceuticals Holdings, Inc. | R&D Day June 21, 2019 www.corbuspharma.com © 2020 Corbus Pharmaceuticals Holdings, Inc. Systemic Sclerosis: The Unmet Need 2 © 2020 Corbus Pharmaceuticals Holdings, Inc. 09 Nov 2020 © 2019 Corbus Pharmaceuticals Holdings, Inc. | R&D Day June 21, 2019 Systemic sclerosis is a rare, debilitating and life-t ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 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 June 30, 2020 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 ...

Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) Q2 2020 Earnings Conference Call August 6, 2020 8:30 AM ET Company Participants Ted Jenkins - Senior Director, IR 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 & Co. Leland Gershell - Oppenheimer & Company Dae Gon Ha - BTIG Elemer Piros - Roth Capi ...

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

PART I - FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) For Q1 2020, the company reported a **net loss** of **$29.7 million**, total assets increased to **$65.2 million** due to a **$46.0 million public offering**, and an **accumulated deficit** of **$222.5 million** raises **going concern doubts** Condensed Consolidated Balance Sheet Data | Balance Sheet Items | March 31, 2020 (Unaudited) | December 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $46,617,921 | $31,748,686 | | Total current assets | $54,657,953 | $38,154,683 | | Total assets | $65,203,822 | $49,142,499 | | Total current liabilities | $34,652,696 | $34,887,706 | | Total liabilities | $42,512,332 | $42,984,934 | | Total stockholders' equity | $22,691,490 | $6,157,565 | | Accumulated deficit | ($222,480,758) | ($192,823,958) | Condensed Consolidated Statements of Operations | Income Statement Items | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Revenue from awards | $1,762,059 | $1,885,682 | | Research and development | $23,947,866 | $21,783,704 | | General and administrative | $7,699,479 | $6,624,747 | | Operating loss | ($29,885,286) | ($26,522,769) | | Net loss | ($29,656,800) | ($26,234,809) | | Net loss per share | ($0.43) | ($0.43) | Condensed Consolidated Statements of Cash Flows | Cash Flow Items | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($27,601,162) | $10,318,298 | | Net cash used in investing activities | ($463,605) | ($73,615) | | Net cash provided by financing activities | $42,934,002 | $37,926,647 | | Net increase in cash and cash equivalents | $14,869,235 | $48,171,330 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=1.%20NATURE%20OF%20OPERATIONS) The company is a clinical-stage pharmaceutical firm focused on rare inflammatory and fibrotic diseases, facing **substantial doubt about its going concern ability** due to **recurring losses** and an **accumulated deficit** of **$222.5 million**, despite recent **public offerings** and key collaborations with Kaken Pharmaceutical and the CFF - The company is a clinical-stage pharmaceutical company focused on developing and commercializing novel therapeutics for rare, chronic, and serious inflammatory and fibrotic diseases[23](index=23&type=chunk) - The company has incurred **recurring losses** since inception, with an **accumulated deficit** of **$222,480,758** as of March 31, 2020. Management has concluded there is **substantial doubt about the company's ability to continue as a going concern** without raising additional capital[25](index=25&type=chunk)[28](index=28&type=chunk) - In February 2020, the company completed an underwritten **public offering**, selling 7,666,667 shares of common stock at **$6.00** per share, for gross proceeds of **$46.0 million**[99](index=99&type=chunk) - The company has a collaboration agreement with Kaken Pharmaceutical to commercialize lenabasum in Japan for dermatomyositis and systemic sclerosis. Kaken made a **$27 million upfront payment** in March 2019, which was recognized as revenue in Q2 2019[74](index=74&type=chunk)[77](index=77&type=chunk)[85](index=85&type=chunk) - The company received a **development award** from the Cystic Fibrosis Foundation (CFF) for up to **$25 million** to support a Phase 2b clinical trial of lenabasum. **Revenue** from this award was **$1.76 million** for the three months ended March 31, 2020[87](index=87&type=chunk)[93](index=93&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) The company, a **Phase 3 clinical-stage pharmaceutical company** developing lenabasum for inflammatory and fibrotic diseases, reported a Q1 2020 **net loss** of **$29.7 million** due to increased R&D and G&A expenses, raised **$43 million** net from a **public offering**, but requires **significant additional capital** to fund operations beyond Q4 2020, with **COVID-19** posing further risks - The company is a **Phase 3 clinical-stage pharmaceutical company** developing novel therapeutics for chronic inflammatory and fibrotic diseases by targeting the human endocannabinoid system (ECS)[118](index=118&type=chunk) - **Lead drug candidate, lenabasum**, is being evaluated in a **Phase 3 SSc study**, a **Phase 2b CF study** (both with top-line data expected in summer 2020), and a **Phase 3 DM study**[120](index=120&type=chunk) - The company has taken precautionary measures due to **COVID-19**, including remote work and monitoring. The pandemic may **disrupt clinical trials**, patient enrollment, and **supply chains**[125](index=125&type=chunk)[126](index=126&type=chunk) - **Cash and cash equivalents** of **$46.6 million** at March 31, 2020, plus an expected **$7.5 million** from the CFF Award, are projected to be **sufficient to fund operations into the fourth quarter of 2020**[167](index=167&type=chunk) - The company will need to raise **significant additional capital** to continue funding operations and clinical trials for lenabasum. The **COVID-19 pandemic** may negatively affect the ability to raise capital[168](index=168&type=chunk)[169](index=169&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) For Q1 2020, **revenue** from the CFF award slightly decreased to **$1.8 million**, while **research and development expenses** increased by **$2.2 million** to **$23.9 million**, and **general and administrative expenses** rose by **$1.1 million** to **$7.7 million**, primarily due to higher compensation and clinical trial costs Comparison of Operating Expenses (Q1 2020 vs Q1 2019) | Expense Category | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | Change | | :--- | :--- | :--- | :--- | | Revenue from awards | $1,762,059 | $1,885,682 | ($123,623) | | Research and Development | $23,948,000 | $21,784,000 | +$2,164,000 | | General and Administrative | $7,699,000 | $6,625,000 | +$1,074,000 | - The increase in R&D expenses was primarily due to a **$2.3 million** increase in compensation costs and a **$270,000** increase in clinical trial costs, offset by a **$431,000** decrease in stock-based compensation[153](index=153&type=chunk) - The increase in G&A expenses was driven by higher costs for compensation (**$1.3M**), legal/audit services (**$0.5M**), stock-based compensation (**$0.5M**), and market research (**$0.5M**). This was partially offset by a non-recurring **$2.7M** royalty payment to CFF made in Q1 2019[157](index=157&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2020, the company had **working capital** of approximately **$20.0 million**, with **net cash used in operations** of **$27.6 million**, while financing activities provided **$42.9 million** from a **public offering**, with existing cash projected to fund operations only into Q4 2020, necessitating further capital raises - As of March 31, 2020, the company had **working capital** of approximately **$20,005,000**[161](index=161&type=chunk) - **Net cash used in operating activities** for Q1 2020 was approximately **$27.6 million**[162](index=162&type=chunk) - **Cash provided by financing activities** in Q1 2020 was approximately **$42.9 million**, mainly from a **public offering** that raised **$46.0 million** in gross proceeds[164](index=164&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk.) The company's **market risk exposure** is primarily limited to short-term **cash and cash equivalents**, with immaterial interest rate exposure and **foreign currency exposure** from holdings in British Pounds, Euros, and Australian Dollars - **Market risk exposure** is limited to **cash and cash equivalents** with maturities of three months or less. The primary risk is **interest income sensitivity** to U.S. interest rate changes, which is not expected to be material[185](index=185&type=chunk) - The company has **foreign currency exposure** from cash held in the United Kingdom (British Pounds, Euros) and Australia (Australian Dollars), as its functional currency is the U.S. Dollar[186](index=186&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that as of March 31, 2020, the company's **disclosure controls and procedures were not effective** due to previously disclosed **material weaknesses** in internal controls over financial reporting, with **no material changes** occurring during Q1 2020 - The principal executive officer and principal financial officer concluded that as of March 31, 2020, the company's **disclosure controls and procedures were not effective**[188](index=188&type=chunk) - The ineffectiveness was attributed to **material weaknesses** in internal controls over financial reporting, as previously disclosed in the Form 10-K for the year ended December 31, 2019[188](index=188&type=chunk) - **No changes** in internal control over financial reporting occurred during Q1 2020 that have materially affected, or are reasonably likely to materially affect, these controls[189](index=189&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings.) The company is **not currently subject to any material legal proceedings**, though it may become a party to various legal proceedings in the ordinary course of business - The company is **not currently subject to any material legal proceedings**[191](index=191&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors.) **No material changes** to risk factors from the 2019 Annual Report were reported, except for new risks related to the **COVID-19 pandemic**, which could adversely affect business operations, clinical trials, manufacturing, and financial condition - There have been **no material changes** to risk factors from the Annual Report on Form 10-K for the year ended December 31, 2019, other than new risks related to the **COVID-19 pandemic**[192](index=192&type=chunk) [Risks Related to COVID-19](index=38&type=section&id=Risks%20Related%20to%20COVID-19) The **COVID-19 pandemic** poses **significant risks** to the company's operations, potentially disrupting clinical trials, manufacturing, supply chains, and access to capital, which could delay approvals and adversely affect financial results - The **COVID-19 pandemic** could **materially and adversely affect** the company's business, financial condition, and results of operations[194](index=194&type=chunk) - The pandemic could adversely impact clinical trial operations, including patient recruitment, site travel, and data monitoring. One clinical trial site has already withdrawn from an open-label study due to **COVID-19**[200](index=200&type=chunk) - Manufacturing operations, including active pharmaceutical ingredient production in China and Italy, could be **disrupted**, limiting the ability to manufacture or ship materials[198](index=198&type=chunk) - Disruption of global financial markets from the pandemic could **reduce the company's ability to access capital** and negatively affect liquidity[199](index=199&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company reported **no unregistered sales of equity securities** during the period - **None**[206](index=206&type=chunk) [Item 3. Defaults Upon Senior Securities](index=39&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) The company reported **no defaults upon senior securities** - **None**[206](index=206&type=chunk) [Item 4. Mine Safety Disclosures](index=39&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is **not applicable** to the company - **Not applicable**[206](index=206&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205.%20Other%20Information.) The company reported **no other information** for this item - **None**[206](index=206&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including amended employment agreements for key executives, CEO and CFO certifications, and XBRL data files - Exhibits filed include amended and restated employment agreements for the CEO, CMO, CFO, CCO, and Head of CMC, as well as required CEO/CFO certifications and XBRL data[207](index=207&type=chunk)

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].