On May 7, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported first quarter 2020 financial results and provides a business update (Press release, CytomX Therapeutics, MAY 7, 2020, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-first-quarter-2020-financial" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-first-quarter-2020-financial" rel="nofollow">View Source [SID1234557276]).
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"The first quarter of 2020 presented unique challenges as we navigated the early stages of the COVID-19 pandemic, but through a strategic pipeline reprioritization and excellent progress with new and existing research and development partnerships, we entered the second quarter well positioned for the remainder of the year and beyond," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "Our continued achievements reflect our long-term strategic vision for CytomX and include the progression of multiple wholly-owned and partnered programs into or towards Phase 2 clinical trials alongside a major new collaboration with Astellas that further validates our Probody platform. Our intensified focus on the application of Probody technology to undruggable targets is aimed at making the biggest difference for patients with cancer."
First Quarter Business Highlights and Recent Developments
COVID 19 Pandemic and Business Continuity
CytomX is committed to ensuring the health, safety and well-being of its clinical study participants, staff at our study sites and our employees. CytomX continues to closely monitor the COVID-19 pandemic situation and is following local, state, and federal guidelines, including, with respect to the conduct of our worldwide clinical trials, emerging Health Authority guidance and IRB/Ethics Committee recommendations.
STRATEGIC REPRIORITIZATION OF WHOLLY OWNED CLINICAL PIPELINE INCREASES FOCUS ON UNDRUGGABLE TARGETS AND FIRST-IN-CLASS DRUG DEVELOPMENT
PROCLAIM-CX-2009-001
CytomX made the decision in March 2020 to temporarily pause new patient enrollment and new site activation in the PROCLAIM-CX-2009-001 study evaluating the CD166-targeting Probody drug conjugate CX-2009. This study includes the Phase 2 expansion study evaluating CX-2009 as monotherapy in patients with hormone receptor (ER, PR) positive, HER2 negative breast cancer. This decision followed the assessment of the evolving COVID-19 pandemic, and the emerging challenges for clinical trial execution within our studies and across the industry. CytomX intends to resume the CX-2009 clinical program as soon as practicable.
PROCLAIM-CX-072-002
CytomX also made the strategic decision in March 2020 to terminate the PROCLAIM-CX-072-002 study evaluating the anti-PD-L1 Probody CX-072 in combination with ipilimumab in melanoma. This follows a re-evaluation of the evolving clinical, competitive, and commercial landscapes in immuno-oncology, taken together with impact of the COVID-19 pandemic.
This strategic decision allows CytomX to focus its resources on its potential first-in-class assets, CX-2009 and CX-2029, to the future evaluation of a combination of CX-072 and CX-2009, and to the generation of additional clinical candidates for advancement to IND filing and clinical trials.
SIGNIFICANT PROGRESS WITHIN NEW AND EXISTING STRATEGIC COLLABORATIONS
Astellas Collaboration – Newly Formed Alliance Expands Research and Development in the Field of T-Cell Engaging Bispecifics
CytomX announced a strategic collaboration with Astellas Pharma Inc. focusing on the discovery, development, and commercialization of novel CD3 targeting T-cell engaging bispecific antibodies for the treatment of cancer. Astellas paid CytomX an upfront cash payment of $80 million, that was received in April, with CytomX eligible to receive future preclinical, clinical, and commercial milestones of over $1.6 billion. CytomX is also eligible to receive tiered royalties on global net sales that range from high-single digits to mid-teens.
AbbVie Collaboration – Phase 2 Expansion Stage Study Advances CX-2029, A First-in-Class Anti-CD71 Probody Drug Conjugate
CytomX announced a $40 million milestone payment, to be received by CytomX from AbbVie in the second quarter, through the achievement of pre-specified criteria for the dose escalation phase of the ongoing Phase 1/2 clinical trial, PROCLAIM-CX-2029. CytomX and AbbVie are finalizing plans for the advancement of CX-2029 to Phase 2 expansion cohorts in select tumor types. Additional information is available at ClinicalTrials.gov using the Identifier NCT003543813.
Bristol Myers Squibb Collaboration – Advancement of ipilimumab Probody into Randomized Phase 2 Study
Bristol Myers Squibb initiated a Phase 2 randomized cohort expansion in its ongoing first-in-human Phase 1/2a trial of the anti-CTLA-4 Probody BMS-986249, a Probody version of the anti-CTLA-4 antibody Yervoy (ipilimumab), in combination with Opdivo (nivolumab) in patients with metastatic melanoma. This advancement triggered a milestone payment of $10 million that was received by CytomX in April. Additional information is available at ClinicalTrials.gov using the Identifier NCT03369223.
Amgen Collaboration – Advancement of Lead T-Cell Bispecific Candidate into IND Enabling Studies
CytomX, in partnership with Amgen, has recently advanced CX-904, a lead T-cell engaging bispecific Probody candidate against Epidermal Growth Factor Receptor (EGFR) and CD3, into IND-enabling studies. CytomX is responsible for the IND filing, targeted for late 2021, and for early clinical development
ASCO 2020 PRESENTATIONS TO HIGHLIGHT MULTIPLE PROBODY CLINICAL-STAGE PROGRAMS
CytomX and its partners announced presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program
CytomX and its partner AbbVie will present data from Phase 1 dose escalation study of the PROCLAIM-CX-2029 Phase 1/2 study of the anti CD71 Probody CX-2029
Bristol Myers Squibb will present data from the Phase 1 dose escalation study of the Phase 1/2a trial of the anti-CTLA-4 Probody BMS-986249
CytomX will present updated data from the Phase 1 dose escalation and dose ranging studies of the PROCLAIM-CX-2009 Phase 1/2 study of the anti CD166 Probody CX-2009
CytomX will present updated data from the Phase 1 dose escalation study, monotherapy expansion studies and combination with ipilimumab studies of PROCLAIM-CX-072 Phase 1/2 study of the anti PD-L1 Probody CX-072
Executive Appointments
Announced the appointments of Carlos Campoy, as senior vice president and chief financial officer and Alison Hannah, M.D., as senior vice president and chief medical officer.
First Quarter 2020 Financial Results
Cash, cash equivalents and short-term investments totaled $247.9 million as of March 31, 2020, compared to $296.1 million as of December 31, 2019.
Revenue was $49.6 million for the three months ended March 31, 2020, compared to $29.5 million for the three months ended March 31, 2019. The net increase in revenue of $20.1 million was primarily due to an increase in revenue of $26.6 million relating to the partial revenue recognition of the $40 million milestone earned from AbbVie associated with the PROCLAIM-CX-2029 project in the first quarter of 2020, an increase of $10 million relating to the milestone earned from Bristol Myers Squibb associated with the initiation of the Phase 2 randomized cohort expansion in the first quarter of 2020, partially offset by a decrease in revenue of $17.4 million relating to the accelerated recognition of revenue in the first quarter of 2019 due to reprioritization within our alliance with Bristol Myers Squibb.
Research and development expenses increased by $6.4 million during the three months ended March 31, 2020 compared to the corresponding period in 2019. The increase was largely attributed to $9.1 million of sublicense fees paid to the University of California, Santa Barbara associated with the milestones and upfront payments earned in the first quarter of 2020 and a $3.0 million license fee to ImmunoGen associated with the first dosing of a patient in the CX-2009 Phase 2 clinical trial during the first quarter of 2020. These increases were partially offset by a $5.0 million decrease associated with the acquisition of technical know-how related to drug conjugate linker-toxin and CD3-based bispecific technologies during the first quarter of 2019.
General and administrative expenses were essentially flat during the three months ended March 31, 2020 compared to the corresponding period in 2019.
Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/Webcast Information
CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 6282129. An archive of the webcast will be available on the CytomX website from May 7, 2020, until May 14, 2020.