Group 1 - CytomX Therapeutics is a biotech company focused on developing novel immunotherapy approaches for various forms of cancer [1] - The company has received a bullish sentiment from analysts, indicating positive expectations for its future performance [1] Group 2 - The analyst has a PhD in biochemistry and extensive experience in analyzing clinical trials and biotech companies, which adds credibility to the insights provided [1] - The mission of the analyst is to educate investors on the science behind biotech businesses to help them make informed decisions [1]

Core Insights - CytomX Therapeutics announced positive interim Phase 1 clinical data for CX-2051 in advanced colorectal cancer [3] - The company secured a $100 million financing from a leading group of healthcare investors [3] Financial Results - The company released its first quarter 2025 financial results alongside the announcement of the Phase 1 data [3] Clinical Development - The focus of the call was primarily on the Phase 1 data for CX-2051, indicating significant progress in the clinical pipeline [3]

Core Insights - CytomX Therapeutics, Inc. experienced a significant stock price increase of 94.46% following the announcement of interim Phase 1 data for its EpCAM PROBODY ADC candidate, CX-2051, in advanced colorectal cancer [1] Clinical Data Summary - As of April 7, 25 advanced metastatic colorectal cancer patients were treated with CX-2051 across five dose levels, administered every three weeks [1] - A confirmed partial overall response rate (ORR) of 28% was observed, with 5 out of 18 patients achieving this response [2] - The median progression-free survival was reported at 5.8 months, with 10 out of 18 patients remaining on study treatment at the data cutoff [3] - CX-2051 was generally well-tolerated, with manageable adverse events and no dose-limiting toxicities observed; most treatment-related adverse events were Grade 1 or Grade 2 in severity [3] - The company has initiated dose expansions at 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg, with plans to enroll 20 patients at each level to determine the recommended Phase 2 dose [3] - Additional Phase 1 data for CX-2051 monotherapy is expected by Q1 2026, with a Phase 2 study planned for the first half of 2026 [3] Future Development Plans - CytomX plans to initiate combination studies of CX-2051 in earlier lines of colorectal cancer in 2026 [4] - The company also aims to evaluate CX-2051 in non-colorectal, EpCAM-expressing tumor indications, with potential Phase 1b study initiation in 2026 [4] Financial Overview - CytomX priced an underwritten offering of approximately 76.92 million shares at $1.30 per share, raising $100 million in gross proceeds [4] - Focused clinical development priorities and cost reductions have extended the company's cash runway into Q2 2026, ending the quarter with $79.9 million in cash, cash equivalents, and investments [5]

CytomX Therapeutics (CTMX) Q1 2025 Earnings Call May 12, 2025 08:00 AM ET Company Participants Chris Ogden - Chief Financial OfficerSean A. McCarthy - Chairman & CEOWayne Chu - Chief Medical OfficerRobert Driscoll - SVP - Equity ResearchDaniel Smith - Equity Research Associate Conference Call Participants Roger Song - Senior Equity Research AnalystAnupam Rama - AnalystPeter Lawson - Analyst Operator Good morning, everyone, and thank you for standing by. Welcome to the Citemx Therapeutics CX 2,051 phase one ...

Financial Data and Key Metrics Changes - CytomX Therapeutics announced a financing of $100 million with a leading group of healthcare investors, which underscores the confidence in the company's progress and potential [3][7] - The company reported a 28% confirmed overall response rate and a 94% disease control rate for CX-2051 in metastatic colorectal cancer, with a preliminary progression-free survival of 5.8 months [11][26] Business Line Data and Key Metrics Changes - CX-2051, an antibody-drug conjugate targeting EpCAM, has shown promising results in a Phase I clinical trial focused exclusively on metastatic colorectal cancer [11][19] - The trial included a heavily pretreated patient population, with a median of four prior lines of therapy, indicating the drug's potential effectiveness in late-line treatment settings [21] Market Data and Key Metrics Changes - Colorectal cancer is a significant global health issue, with approximately 1.9 million new cases diagnosed annually, expected to rise to over 3 million in the coming decades [7][8] - The current five-year survival rate for metastatic colorectal cancer is only 13%, highlighting the urgent need for innovative treatment options [8] Company Strategy and Development Direction - The company aims to position CX-2051 as a new standard of care in late-line colorectal cancer treatment, with plans to expand its use into earlier lines of therapy [36][37] - There is a vision to explore CX-2051's potential in other solid tumors, leveraging the high expression of EpCAM across various cancer types [37][38] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the drug's performance and its potential to transform colorectal cancer treatment, emphasizing the inadequacy of current standard therapies [36][37] - The company plans to generate additional data from ongoing expansions and engage with regulatory authorities to expedite the development process [48][62] Other Important Information - The safety profile of CX-2051 has been favorable, with no dose-limiting toxicities observed to date, and the adverse events reported were manageable and reversible [30][31] - The company is exploring prophylactic strategies to manage gastrointestinal toxicities associated with the treatment [66] Q&A Session Summary Question: What differences are seen between stable disease and responders in terms of baseline characteristics? - Management noted the overall impressive disease control rate and response rate, indicating that they will continue to analyze patient characteristics that may influence outcomes [44][45] Question: What is the current development strategy for pivotal endpoints and moving into earlier lines? - The focus is on generating data from expansion cohorts, with plans to discuss optimal paths for Phase II and potentially Phase III trials with regulatory authorities [48][62] Question: Can you provide details on the management of serious adverse events? - The safety profile is encouraging, and while specific patient details cannot be disclosed, the adverse events reported align with the overall profile [54][55] Question: Are there plans for accelerated development or breakthrough designations? - Discussions with regulatory authorities are anticipated, and the expansion data will be crucial for these conversations [62] Question: Is there evidence of high EpCAM expression in earlier stage patients? - EpCAM is well-established as a CRC target, and its expression is consistent throughout the disease's natural history, supporting its use in earlier treatment lines [71][72] Question: Will higher dosing be considered based on emerging signals? - While the current dose levels are being expanded, the company is cautious about escalating doses without observing dose-limiting toxicities [75][76]

Core Viewpoint - CytomX Therapeutics, Inc. has announced an underwritten offering of 76,923,076 shares of its common stock at a price of $1.30 per share, aiming to raise approximately $100 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering is expected to close on May 13, 2025, subject to customary closing conditions [1]. - The net proceeds from the offering will be utilized for research and development, general corporate purposes, and working capital needs [2]. - The offering is led by Longitude Capital, with participation from several investment firms including OrbiMed and Venrock Healthcare Capital Partners [2]. Group 2: Company Overview - CytomX is a clinical-stage biopharmaceutical company focused on developing conditionally activated biologics for cancer treatment [6]. - The company’s pipeline includes therapeutic candidates such as CX-2051, a masked ADC targeting EpCAM, and CX-801, a masked interferon alpha-2b PROBODY cytokine [6]. - CytomX has established collaborations with major oncology leaders including Amgen and Bristol Myers Squibb [6].

Financial Performance - Total revenue for Q1 2025 was $50.9 million, a 22% increase from $41.5 million in Q1 2024[7] - Net income for Q1 2025 was $23.5 million, compared to $13.8 million in Q1 2024, representing a 70% increase[16] - Total operating expenses decreased to $28.3 million in Q1 2025 from $29.8 million in Q1 2024, a reduction of 5%[8] - Research and development expenses were $18.9 million for Q1 2025, down 17% from $22.1 million in Q1 2024[9] Cash and Investments - Cash, cash equivalents, and investments totaled $79.9 million as of March 31, 2025, down from $100.6 million as of December 31, 2024[6] - The company’s cash runway has been extended into the second quarter of 2026 due to focused clinical development priorities and cost reductions[10] Clinical Development - CX-2051 Phase 1 dose expansions initiated at 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, with additional data expected by Q1 2026[4] - Planning to initiate a Phase 2 study for CX-2051 in advanced colorectal cancer in the first half of 2026[3] - CX-801 Phase 1a translational data in advanced melanoma expected in the second half of 2025[4] Collaborations and Milestones - Astellas collaboration achieved a milestone payment of $5.0 million in February 2025[10]

Core Insights - CytomX Therapeutics announced positive interim clinical results for CX-2051, an EpCAM-directed antibody-drug conjugate (ADC) for advanced colorectal cancer (CRC), highlighting its strategic importance for the company [3][7] - The company has initiated dose expansions for CX-2051 at 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg, with a Phase 2 study planned for the first half of 2026 [7][3] - Financial results for Q1 2025 show total revenue of $50.9 million, an increase from $41.5 million in Q1 2024, driven by collaborations with Bristol Myers Squibb and Amgen [9][10] Pipeline Program Updates - CX-2051 is currently in a Phase 1 dose escalation study, with an update on data from at least 70 patients expected by Q1 2026 [7] - CX-801, a PROBODY interferon alpha-2b, is also in development, with initial Phase 1a translational data expected in the second half of 2025 [7][5] - The company is focusing on combination therapy with CX-801 and KEYTRUDA, aiming to initiate this in 2025 [7] Financial Overview - As of March 31, 2025, the company reported cash, cash equivalents, and investments totaling $79.9 million, down from $100.6 million at the end of 2024 [8] - Total operating expenses for Q1 2025 were $28.3 million, a decrease from $29.8 million in Q1 2024, with R&D expenses at $18.9 million, down from $22.1 million [10][11] - The net income for Q1 2025 was $23.5 million, compared to $13.8 million in Q1 2024, reflecting improved operational efficiency [18]

Core Insights - CytomX Therapeutics announced positive interim Phase 1 data for its EpCAM PROBODY ADC candidate, CX-2051, in advanced, late-line colorectal cancer (CRC) [2][3] - The study demonstrated a 28% confirmed response rate and a median progression-free survival of 5.8 months [1][13] - The company plans to initiate a Phase 2 study in the first half of 2026 [1][13] Patient Characteristics - A total of 25 advanced metastatic CRC patients were treated, with a median of 4 prior lines of therapy [6] - 64% of patients had liver metastases, 64% had KRAS mutations, and 96% were microsatellite stable [6] Efficacy Results - 28% of patients (5 out of 18) achieved confirmed partial responses according to RECIST v1.1 [1][6] - At the highest dose of 10 mg/kg, 43% of evaluable patients (3 out of 7) achieved confirmed partial responses [1][6] - The Disease Control Rate was 94% across the three dose groups [6] Safety Results - CX-2051 was generally well-tolerated with no dose-limiting toxicities observed [1][13] - Most treatment-related adverse events were Grade 1 or Grade 2, with common events including diarrhea, nausea, and fatigue [13] Development Plans - Dose expansions have been initiated at doses of 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg Q3W, with 20 patients expected to be enrolled at each level [13] - Additional Phase 1 data updates are anticipated by Q1 2026, and combination studies in earlier lines of CRC may begin in 2026 [13]

Financial Performance - Revenues for the three months ended March 31, 2025, increased to $50,917,000, up 22% from $41,463,000 in the same period of 2024[19] - Net income for the first quarter of 2025 was $23,525,000, compared to $13,791,000 in Q1 2024, representing a 70% increase[19] - Basic net income per share for Q1 2025 was $0.27, up from $0.17 in Q1 2024, reflecting a 58.8% increase[43] - Total revenue for the three months ended March 31, 2025, was $50,917,000, compared to $41,463,000 in Q1 2024, indicating a growth of 22.5%[50] - The Company recognized $50.9 million in total revenue for the three months ended March 31, 2025, compared to $41.5 million for the same period in 2024, representing a 22% increase[108] - The Company’s income from operations for the three months ended March 31, 2025, was $22.6 million, compared to $11.7 million for the same period in 2024, an increase of 93%[108] Expenses and Liabilities - Operating expenses decreased to $28,296,000, down 5% from $29,806,000 year-over-year, primarily due to reduced research and development costs[19] - Research and development expenses for the three months ended March 31, 2025, were $18.9 million, down from $22.1 million in the same period in 2024, a decrease of 14%[108] - General and administrative expenses increased by $1.7 million (22%) to $9.4 million for the three months ended March 31, 2025, compared to $7.8 million in 2024, driven by restructuring and personnel-related expenses[149] - Total liabilities decreased significantly to $73,448,000 from $120,989,000 at the end of 2024, indicating improved financial health[17] - The company recorded total stock-based compensation expense of $2.0 million for the three months ended March 31, 2025, compared to $1.9 million for the same period in 2024, an increase of 5.3%[104] Cash and Assets - Cash, cash equivalents, and restricted cash at the end of the first quarter of 2025 totaled $48,632,000, compared to $37,102,000 at the end of Q1 2024[24] - Total current assets decreased to $86,628,000 as of March 31, 2025, down from $107,305,000 at the end of 2024[17] - Cash, cash equivalents, and short-term investments totaled $79.9 million as of March 31, 2025, compared to $100.6 million at the end of 2024[131] - As of March 31, 2025, the fair value of the company's investments was $81,195,000, down from $101,870,000 as of December 31, 2024, primarily due to changes in interest rates[47] Restructuring and Workforce - The company announced a restructuring plan in January 2025, which included a 40% reduction in workforce to streamline operations[30] - The company announced a restructuring plan resulting in a workforce reduction of approximately 40%, with total restructuring charges estimated at $3.0 million[130] - The company recognized aggregate restructuring costs of approximately $2.9 million during the three months ended March 31, 2025, primarily related to severance and benefits[150] Future Financing and Capital Needs - The company expects its liquidity to fund operations into the second quarter of 2026 but will need to raise additional capital thereafter[30] - The company is evaluating future financing opportunities to secure additional funding for continued operations[30] - The company expects to need substantial additional funds to advance the development of its product candidates, with no guarantee of availability on acceptable terms[182] - The company intends to seek additional funding through collaborations, public or private equity offerings, or debt financings, but its ability to raise funds may be limited due to a declining stock price[186] Clinical Development and Product Candidates - CX-2051, a conditionally activated ADC targeting EpCAM, has shown a 28% overall response rate in a Phase 1 study with 18 efficacy-evaluable patients[122] - The disease control rate for CX-2051 at the expansion doses was 94%, with a preliminary median progression-free survival of 5.8 months[122] - The IND for CX-801 was allowed to proceed by the FDA in January 2024, with the first patient dosed in Q3 2024[125] - The company plans to initiate a Phase 2 study in colorectal cancer in the first half of 2026[124] - CX-904, a partnered T-cell engager, was discontinued based on clinical observations and pipeline priorities[126] - The company has no products on the market and its ability to achieve profitability depends on obtaining regulatory approvals for its product candidates[192] Risks and Challenges - The company has a history of operating losses and expects to continue incurring significant losses due to research and development costs[181] - The company faces risks related to the lengthy and expensive clinical development process, with uncertain outcomes for its product candidates[176] - The company has experienced recurring losses from operations and negative cash flows, raising substantial doubt about its ability to continue as a going concern[187] - The company may face delays in clinical trials due to various factors, including regulatory requirements and patient recruitment challenges[190][193] - The company has no assurance that its product candidates will be safe or effective, which could lead to delays or denials of regulatory approval[201][202] - The company is exposed to various global risks, including political unrest and regulatory compliance, which could adversely affect its business prospects[214] Collaborations and Agreements - The collaboration with Astellas Pharma focuses on developing antibody compounds for cancer treatment using the company's PROBODY therapeutic technology[60] - The Company received an upfront payment of $80.0 million from Astellas and potential contingent payments of up to approximately $1.6 billion under the Astellas Agreement[62] - Under the BMS Agreement, the Company received an upfront payment of $50.0 million and contingent payments of up to $25.0 million for additional targets[67][69] - The Company received an upfront payment of $35.0 million from Moderna, including $5.0 million of prepaid research and development service fees[79] - The Company received an upfront fee of $30.0 million from Regeneron, with potential milestone payments of up to approximately $0.8 billion[83]