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].

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 ...