CytomX Therapeutics (NASDAQ: CTMX ) is a biotech focused on development of novel immunotherapy approaches for different forms of cancer. In my first coverage of them, I expressed a bullish sentiment primarily onI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of in ...

CytomX Therapeutics, Inc. (NASDAQ:CTMX) CX-2051 Phase 1 Interim Clinical Data in Advanced Colorectal Cancer May 12, 2025 8:00 AM ET Company Participants Sean McCarthy - Chairman and CEO Chris Ogden - CFO Wayne Chu - Chief Medical Officer Conference Call Participants Roger Song - Jefferies Anupam Rama - JPMorgan Peter Lawson - Barclays Robert Driscoll - Wedbush Securities Daniel Smith - H.C. Wainwright Operator Good morning, everyone, and thank you for standing by. Welcome to the CytomX Therapeutics CX-2051 ...

CytomX Therapeutics, Inc.‘s CTMX share price was up 94.46% at last check on Monday.The stock surged after the company reported interim Phase 1 data for its EpCAM PROBODY ADC candidate, CX-2051, in advanced, late-line colorectal cancer (CRC).As of April 7, 25 advanced metastatic CRC patients were treated with CX-2051 across dose levels 1 through 5.CX-2051 was administered on a once every three-week schedule (Q3W).The 2.4 mg/kg and 4.8 mg/kg doses were single-patient dose escalation cohorts that were not anti ...

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]

SOUTH SAN FRANCISCO, Calif., May 12, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (NASDAQ:CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, today announced the pricing of an underwritten offering of 76,923,076 shares of its common stock at an offering price of $1.30 per share, before underwriting discounts and commissions. All of the shares are being offered by the Company. The gross proceeds from the offering are expected to be approximately $100 million before de ...

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]

- Announced Positive Interim Data From Ongoing Phase 1 Dose Escalation Study of EpCAM Antibody Drug Conjugate (CX-2051) in Patients with Advanced Colorectal Cancer (CRC) - - Initiated CX-2051 Phase 1 dose expansions at 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses. Additional CX-2051 Phase 1 data update expected by Q1 2026 - - Planning CX-2051 Phase 2 study initiation in 1H 2026 - - CX-801 (PROBODY® Interferon alpha-2b) Phase 1a translational data in advanced melanoma expected in 2H 2025 - - Company to host con ...

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]

Core Insights - CytomX Therapeutics, in collaboration with Moderna, has announced promising preclinical data for an mRNA-encoded masked IL-12 therapeutic, which demonstrates significant anti-tumor activity and enhanced tolerability [1][2] Company Overview - CytomX Therapeutics is a clinical-stage biopharmaceutical company focused on developing conditionally activated, masked biologics aimed at localized treatment within the tumor microenvironment [3] - The company utilizes its proprietary PROBODY therapeutic platform to create safer and more effective cancer therapies [3] - CytomX's pipeline includes various therapeutic candidates such as CX-2051, a masked ADC targeting EpCAM, and CX-801, a masked interferon alpha-2b PROBODY cytokine [3] Collaboration and Technology - The collaboration with Moderna combines CytomX's PROBODY masking technology with Moderna's mRNA technology to create a selectively activated IL-12 therapeutic [2] - The new mRNA therapeutic is designed to minimize systemic activity while maximizing anti-tumor efficacy within the tumor microenvironment [2] Presentation Details - The preclinical data will be presented at the American Association for Cancer Research (AACR) Annual Meeting on April 28, 2025, under the title "An mRNA-encoded masked IL-12 improves systemic tolerability while maintaining anti-tumor efficacy in preclinical studies" [3]