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Corvus Pharmaceuticals(CRVS) - 2023 Q3 - Earnings Call Transcript
2023-11-08 03:46
Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) Q3 2023 Earnings Conference Call November 7, 2023 4:30 PM ET Company Participants Zack Kubow - Real Chemistry Leiv Lea - CFO Richard Miller - CEO Jim Rosenbaum - SVP of Research Conference Call Participants Aydin Huseynov - Ladenberg Jeff Jones - Oppenheimer Operator Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Corvus Pharmaceuticals Third Quarter 2023 Business Update and Financial Results Conference Call. At this time, all p ...
Corvus Pharmaceuticals(CRVS) - 2023 Q3 - Quarterly Report
2023-11-06 16:00
Financial Position - As of September 30, 2023, the company had cash, cash equivalents, and marketable securities of $32.2 million, down from $42.3 million as of December 31, 2022, with an accumulated deficit of $328.1 million[226]. - The company reported an increase in interest income of $0.2 million for the three months ended September 30, 2023, due to rising interest rates[217]. - Cash provided by financing activities amounted to $7.9 million during the nine months ended September 30, 2023, primarily from net proceeds of common stock issuance through the at-the-market offering program[261]. Clinical Development - The company completed an End-of-Phase/Pre-Phase 3 meeting with the FDA in August 2023, anticipating to initiate a Phase 3 clinical trial of soquelitinib in early 2024, enrolling 150 patients with relapsed PTCL[189]. - The company plans to initiate a Phase 1 clinical trial of soquelitinib in solid tumors in the first half of 2024, based on preclinical findings suggesting enhanced anti-tumor immunity[192]. - The company is collaborating with the Kidney Cancer Research Consortium to evaluate ciforadenant in a Phase 1b/2 clinical trial for metastatic renal cell cancer, with interim data expected in early 2024[215]. - In the 200 mg cohort of the Phase 1/1b clinical trial, as of May 18, 2023, there were 3 complete responses (CRs) and 3 partial responses (PRs) among 20 evaluable patients[188]. - The 200 mg dose of soquelitinib was determined to be optimal, showing higher response rates and longer disease control in patients[202]. - Preclinical data for soquelitinib indicated in vivo anti-tumor activity across several mouse tumor models, including colon, renal, melanoma, and both B cell and T cell tumors[235]. - Soquelitinib demonstrated a dose-dependent Th1 skewing and Th2 blockade in vitro, supporting the selection of a 200 mg dose for further studies[233]. - The company is evaluating the potential registrational clinical trial for soquelitinib, alongside other product candidates like ciforadenant and mupadolimab[238]. Expenses and Income - For the nine months ended September 30, 2023, general and administrative expenses decreased by $1.3 million compared to the same period in 2022, primarily due to a $0.6 million decrease in personnel costs[216]. - For the nine months ended September 30, 2023, the company recognized a decrease in sublease income of $0.4 million due to the expiration of the sublease agreement with Angel Pharmaceuticals in January 2023[218]. - The company reported a decrease in sublease income of $0.1 million due to the expiration of a building sublease agreement with Angel Pharmaceuticals in January 2023[237]. - Corvus Pharmaceuticals reported total operating lease costs of $418,000 for the three months ended September 30, 2023, compared to $414,000 for the same period in 2022, reflecting a slight increase of 1%[236]. - The company incurred research and development costs of $306,000 for the three months ended September 30, 2023, consistent with the previous year, while total operating lease costs for the nine months ended September 30, 2023, were $1.226 million, up from $987,000 in 2022, representing a 24% increase[236]. Risks and Compliance - Corvus Pharmaceuticals is exposed to risks related to compliance with healthcare laws, which could result in significant penalties if violations occur[246]. - The remaining lease term for operating leases is 1.3 years as of September 30, 2023, down from 2.3 years in the previous year[236]. - The company expects to increase spending related to the development and commercialization of its product candidates, funded through equity and/or debt financings[227]. - Corvus Pharmaceuticals is focusing on the development of immune modulator product candidates aimed at treating solid cancers and T cell lymphomas, with three candidates currently in clinical development[232].
Corvus Pharmaceuticals(CRVS) - 2023 Q2 - Earnings Call Transcript
2023-08-09 01:57
Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) Q2 2023 Earnings Call Transcript August 8, 2023 4:30 PM ET Company Participants Zack Kubow - IR-Real Chemistry Leiv Lea - CFO Richard Miller - CEO Conference Call Participants Roger Song - Jefferies Aydin Huseynov - Ladenburg Thalmann Rosemary Li - Cantor Fitzgerald Jeff Jones - Oppenheimer Operator Thank you for standing by. This is the conference operator. Welcome to the Corvus Pharmaceuticals Second Quarter 2023 Conference Call. [Operator Instructions]. I would ...
Corvus Pharmaceuticals(CRVS) - 2023 Q2 - Quarterly Report
2023-08-07 16:00
Financial Resources and Losses - As of June 30, 2023, the company had capital resources of $37.0 million, which are insufficient to fund ongoing and planned clinical trials for its product candidates [219]. - The company has incurred significant operating losses since inception and expects to continue incurring losses for the foreseeable future [213]. - The company has received approximately $41.0 million in outside investment for Angel Pharmaceuticals, but this cash is not available for the company's use [219]. - The company may need to seek additional financing sooner than planned, which could result in dilution to stockholders and affect business operations [219]. - The company does not expect to commercialize any product candidates for at least several years, which may affect stock price [337]. Product Development and Clinical Trials - The company is focused on the clinical development of soquelitinib, ciforadenant, and mupadolimab, and will continue to expend substantial resources on these candidates [216]. - The company is developing three product candidates: soquelitinib, ciforadenant, and mupadolimab, but only a small percentage of drugs in development receive regulatory approval for commercialization [249]. - The company is currently enrolling patients in clinical trials for T-cell lymphomas and renal cell carcinoma (RCC), but enrollment challenges could delay trial completion and revenue generation [269]. - The company is conducting oncology clinical trials for soquelitinib in North America, Australia, and South Korea, and for ciforadenant in North America, in collaboration with the Kidney Cancer Research Consortium [288]. - The company plans to collaborate with diagnostic companies to identify patients for clinical trials, which may require regulatory approval for companion diagnostics [242]. Regulatory Challenges and Compliance - The company has no products on the market, and its ability to achieve profitability depends on obtaining regulatory approvals for its product candidates [246]. - Regulatory approval processes for the company's product candidates are lengthy and expensive, with no guarantee of success [239]. - The company faces significant regulatory scrutiny regarding manufacturing processes, and any compliance failures could result in costly remedial measures [283]. - The company must comply with cGMP regulations for manufacturing, and any failure could lead to delays or inability to commercialize products [306]. - Regulatory authorities may impose additional requirements for companion diagnostics, which could delay or prevent the commercialization of product candidates [265]. Risks and Uncertainties - The company faces risks related to the success of its clinical trials, including potential delays and increased costs [224]. - Delays in clinical trials could result from various factors, including enrollment issues, funding shortages, and regulatory compliance challenges, potentially harming the company's commercial prospects [253]. - The COVID-19 pandemic has introduced additional risks, including disruptions in clinical trial activities and potential delays in regulatory interactions, which could adversely affect the company's business [272]. - The company faces challenges in scaling up manufacturing capacity for product candidates, which could delay development and commercialization [308][309]. - The company faces risks related to the complexity of its supply chain, which could disrupt product availability [333]. Market and Competitive Landscape - The company faces intense competition in the immunoregulatory therapeutics field from larger, better-funded pharmaceutical and biotechnology companies, as well as universities and research institutions [394]. - The company may not achieve market acceptance for its product candidates, which depends on various factors including pricing and patient willingness to pay [376]. - The addressable patient population for the company's product candidates may be limited, and estimates of cancer prevalence could prove incorrect, potentially affecting market opportunities [396]. - Legislative and regulatory changes in the U.S. and EU may limit coverage and reimbursement for newly approved drugs, affecting profitability [380]. - The exclusivity period for mupadolimab could be shortened due to Congressional action or FDA decisions, potentially leading to earlier generic competition [386]. Strategic Partnerships and Alliances - Under a collaboration with Angel Pharmaceuticals, Angel is responsible for the clinical development and commercialization of licensed pipeline programs in greater China, including ongoing Phase 1/1b clinical trials for soquelitinib and mupadolimab [251]. - The company may not realize the benefits of strategic alliances or partnerships due to perceived risks by third parties [392]. - The company faces significant competition in establishing strategic alliances, which may be time-consuming and complex [362]. - Angel Pharmaceuticals was formed in October 2020 to develop and commercialize three clinical-stage candidates in greater China, with potential risks from U.S.-China relations impacting operations [393]. Compliance and Regulatory Environment - Compliance with healthcare laws and regulations is critical, and violations could result in significant penalties, including exclusion from government-funded healthcare programs [410]. - The company may face substantial costs to ensure compliance with environmental laws and regulations, which could impair product development efforts [411]. - The FDA's new Clinical Trials Regulation (CTR) allows for a centralized application process for multi-center trials, which may impact the company's clinical trial timelines and regulatory compliance [252]. - The FDA and other regulatory agencies have faced disruptions that could delay the approval and commercialization of new products [321]. - The company must demonstrate safety and efficacy in clinical trials to achieve marketing approvals, which is a complex process [338].
Corvus Pharmaceuticals(CRVS) - 2023 Q1 - Earnings Call Transcript
2023-05-09 02:24
Financial Data and Key Metrics Changes - The net loss for the first quarter of 2023 was $7.9 million, a slight improvement from a net loss of $8.3 million in the same period in 2022 [48] - Cash, cash equivalents, and marketable securities totaled $34.5 million as of March 31, 2023, down from $42.3 million at the end of 2022 [49] - Research and development expenses decreased to $4.6 million in Q1 2023 from $5.1 million in Q1 2022, reflecting a focus on managing cash burn [3][4] Business Line Data and Key Metrics Changes - The ongoing Phase 1/1b trial of CPI-818 in T cell lymphoma has shown promising results, with two complete responses and three partial responses among 19 evaluable patients [15][19] - The median progression-free survival (PFS) for patients with an absolute lymphocyte count (ALC) above 900 was reported at 19.9 months, compared to just 2.1 months for those below 900 [69] Market Data and Key Metrics Changes - The company is preparing for a meeting with the FDA in Q3 2023 to discuss a Phase 3 clinical trial for CPI-818, which is expected to include approximately 150 patients [5][14] - The company is also focused on expanding the application of CPI-818 beyond T cell lymphoma to solid tumors, supported by recent preclinical data [7][10] Company Strategy and Development Direction - The company is prioritizing CPI-818 as its most advanced ITK inhibitor, aiming for a potential registration trial for T cell lymphoma [10][50] - There is an emphasis on establishing collaborations to support the development of product candidates and managing cash burn effectively [4][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of CPI-818 to address unmet needs in cancer treatment [10][19] - The company plans to present additional interim data at the International Conference on Malignant Lymphoma in June 2023, which may further validate the efficacy of CPI-818 [51][60] Other Important Information - The company has extended its intellectual property covering CPI-818, with patents issued in multiple countries [17] - The safety profile of CPI-818 appears favorable, with no dose-limiting toxicities observed in trials [53] Q&A Session Summary Question: What is the expected design for the Phase 3 trial with the FDA? - Management expects to discuss the trial design and standard therapies in the control arm, with a focus on a randomized controlled trial [74][75] Question: What are the historical response rates for the control agents? - The overall response rate (ORR) for standard agents is about 25%, with short-lived responses [76] Question: Will there be an interim look at the data for response rates? - Management confirmed plans for an interim look at the data, consistent with recent FDA guidelines [43] Question: What is the plan for CPI-818 in immune diseases? - The company is still considering whether to move into immune diseases with CPI-818, depending on progress in cancer indications [91] Question: Is there any delay in the ciforadenant trial? - Management clarified that there is no slowdown in the ciforadenant trial, which is actively enrolling patients [92]
Corvus Pharmaceuticals(CRVS) - 2023 Q1 - Quarterly Report
2023-05-07 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Corvus Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37719 46-4670809 (State or other jurisdiction of incorporation) (Commissio ...
Corvus Pharmaceuticals(CRVS) - 2022 Q4 - Earnings Call Transcript
2023-03-29 02:55
Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) Q4 2022 Earnings Conference Call March 27, 2023 4:30 PM ET Company Participants Zack Kubow - Investor Relations-Real Chemistry Leiv Lea - Chief Financial Officer Richard Miller - Co-Founder, President & Chief Executive Officer James Rosenbaum - Senior Vice President-Research Conference Call Participants Mara Goldstein - Mizuho Roger Song - Jefferies Operator Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Corvus Pharmaceuticals F ...
Corvus Pharmaceuticals(CRVS) - 2022 Q4 - Annual Report
2023-03-27 16:00
Financial Performance - The net loss for 2022 was $41.307 million, compared to a net loss of $43.241 million in 2021, reflecting a 4.5% improvement[496]. - The net loss per share, basic and diluted, improved to $0.89 in 2022 from $1.03 in 2021[496]. - Total operating expenses for the year ended December 31, 2022, were $32.565 million, a decrease of 15.7% from $38.630 million in 2021[496]. - The Company reported a loss before income tax of $41.307 million for the year ended December 31, 2022, compared to a loss of $43.241 million in 2021[579]. - The net loss for the year ended December 31, 2022, was $41.3 million, resulting in a net loss per share of $0.89, compared to a net loss of $43.2 million and a net loss per share of $1.03 in 2021[541]. Cash and Liquidity - As of December 31, 2022, the company had cash, cash equivalents, and marketable securities totaling $42.3 million, with a significant portion in U.S. Treasury securities[475]. - Cash and cash equivalents at the end of 2022 were $13.159 million, down from $63.458 million at the end of 2021[502]. - The company incurred a net cash used in operating activities of $27.023 million in 2022, an improvement from $36.715 million in 2021[502]. - The Company has financed its operations primarily with proceeds from the sale of stock and will need to raise additional capital to meet its business objectives[515]. - The Company had cash, cash equivalents, and short-term marketable securities totaling $42.3 million as of December 31, 2022, expected to fund operations for at least 12 months[511]. Research and Development - Research and development expenses were $24.4 million, $29.1 million, and $31.8 million for the years ended December 31, 2022, 2021, and 2020, respectively[171]. - Research and development expenses decreased to $24.468 million in 2022 from $29.115 million in 2021, a reduction of 16.5%[496]. - The company continues to focus on the clinical development of its product candidates, including CPI-818, ciforadenant, and mupadolimab, with significant resources expected to be expended in the future[508]. - The Company recorded total stock-based compensation expenses of $2.692 million for the year ended December 31, 2022, a decrease from $4.232 million in 2021[574]. Assets and Liabilities - Total current assets decreased from $71.3 million in 2021 to $43.7 million in 2022, primarily due to a reduction in cash and cash equivalents[492]. - Total liabilities remained relatively stable at $12.1 million in 2022 compared to $12.3 million in 2021[492]. - Stockholders' equity decreased from $97.2 million in 2021 to $56.1 million in 2022, driven by an increase in the accumulated deficit from $266.4 million to $307.7 million[492]. - As of December 31, 2022, the Company had an accumulated deficit of $307.688 million[510]. Employment and Operations - The company had 29 total employees as of December 31, 2022, with 22 primarily engaged in research and development activities[173]. - The company leases approximately 27,280 square feet of office and research facilities, with a lease expiring in 2025[175]. - The company is exploring alternatives for additional space to accommodate anticipated growth[175]. Tax and Regulatory Matters - The effective income tax rate for the Company was 0% for the years ended December 31, 2022, 2021, and 2020, primarily due to a valuation allowance against deferred tax assets[580]. - The Company recorded a full valuation allowance for deferred tax assets due to uncertainty about future utilization[536]. - As of December 31, 2022, the Company had federal net operating loss (NOL) carryforwards of approximately $219.7 million and state NOL carryforwards of approximately $274.9 million, with $155.3 million of federal NOLs not expiring[583]. - The valuation allowance against deferred tax assets increased by approximately $9.2 million for the year ended December 31, 2022, primarily due to the increase in the Company's net operating loss carryforward[582]. - The Company had $8.6 million of federal and $4.7 million of state research and development tax credit carryforwards available to reduce future income taxes[584]. Investments and Equity - The company reported a gain from the sale of property and equipment of $22, while also recognizing a loss from equity method investment of $10.005 million in 2022[496]. - The company's investment in Angel Pharmaceuticals resulted in recognized losses of $10.0 million, $4.8 million, and $0.2 million for the years ended December 31, 2022, 2021, and 2020, respectively[551]. - The Company has a 49.7% ownership interest in Angel Pharmaceuticals as of December 31, 2022, down from 53.2% after third-party financing[551]. - The aggregate potential milestone payments to Vernalis for licensed products were approximately $220 million as of December 31, 2022, with no clinical or regulatory milestones completed during the year[557]. - The Company is required to pay tiered incremental royalties to Vernalis based on annual net sales of licensed products, with rates ranging from mid-single digits to low-double digits[557].
Corvus Pharmaceuticals(CRVS) - 2022 Q3 - Earnings Call Transcript
2022-11-06 11:39
Financial Data and Key Metrics Changes - As of September 30, 2022, Corvus Pharmaceuticals had cash, cash equivalents, and marketable securities totaling $49.6 million, down from $69.5 million at December 31, 2021, indicating a decrease of approximately 29% [5] - Research and development expenses for Q3 2022 were $10.4 million, an increase from $7 million in Q3 2021, primarily due to a $5.5 million rise in drug manufacturing costs, partially offset by a $2.2 million reduction in clinical trial costs [6] - The net loss for Q3 2022 was $14.8 million, compared to a net loss of $10.7 million for the same period in 2021, reflecting an increase in losses of approximately 38% [9] Business Line Data and Key Metrics Changes - The lead program, CPI-818, is currently in a Phase 1/1b clinical trial for relapsed T cell lymphoma, with an optimal dose identified at 200 milligrams taken orally twice daily [12][13] - The company is also advancing ciforadenant, which is being evaluated in a Phase Ib/II clinical trial for metastatic renal cell cancer in combination with ipilimumab and nivolumab [19] - Mupadolimab, an anti-CD73 antibody, is expected to enter a Phase I/Ib clinical trial in China, while its development in the US is currently paused [25] Market Data and Key Metrics Changes - The ongoing CPI-818 trial has seen most patients treated from the US, with increasing enrollment from China, Australia, and South Korea [32] - The Phase Ib/II trial for ciforadenant is being led by the University of Texas MD Anderson Cancer Center, part of a consortium of premier institutions [20] Company Strategy and Development Direction - Corvus Pharmaceuticals aims to modulate immune cell activity through targeted drugs, with a focus on expanding treatment options for cancer and immune-mediated diseases [10] - The company plans to initiate clinical trials for CPI-818 in autoimmune and allergic diseases in the first half of 2023, while continuing to prioritize T-cell lymphoma as a primary focus [17][39] - The strategy includes leveraging collaborations, such as with Angel Pharmaceuticals in China, to support product development [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the cash runway extending into early 2024, allowing for continued advancement of the clinical pipeline [6] - The company anticipates presenting new data for CPI-818 at the American Society of Hematology Meeting on December 12, which will include updates on its efficacy and safety [18] - Management is optimistic about the potential catalysts across their portfolio in the next 12 months, including ongoing trials and collaborations [27] Other Important Information - The company is focused on achieving significant clinical data in 2023, particularly for CPI-818 in T-cell lymphoma and autoimmune diseases [41] - The development of mupadolimab is ongoing in China, with plans to initiate trials soon, while US plans remain on hold due to resource allocation [43] Q&A Session Summary Question: Can you confirm if you are continuing to monitor any patients in higher dose cohorts for CPI-818? - Management confirmed that enrollment in higher dose cohorts (400 and 600 mg) has been completed, focusing on the 200 mg cohort for upcoming presentations [30] Question: How might the zero-COVID policy in China affect current clinical trials? - Management indicated that the zero-COVID policy has not significantly impacted their trials, with recent improvements in the situation [33] Question: What is the biology that CPI-818 is trying to address for autoimmune and allergic diseases? - Management explained that CPI-818 targets T-cell differentiation, particularly affecting Th2 cells involved in allergic diseases, with plans to focus on atopic dermatitis as a clinical target [40] Question: What would be considered good data for the ciforadenant trial? - Management stated that they aim to exceed the historical deep response rate of 32% in the trial, with a focus on achieving complete responses [47]
Corvus Pharmaceuticals(CRVS) - 2022 Q3 - Quarterly Report
2022-11-02 16:00
Table of Contents- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ 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 Corvus Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37719 46-4670809 (State or other jurisdiction of incorporation) (Comm ...