On March 1, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported fourth quarter and full year 2021 financial results, and provided a business update (Press release, CytomX Therapeutics, MAR 1, 2022, View Source [SID1234609280]).
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"2021 was a successful year of sustained execution and delivery on CytomX’s commitment to destroying cancer differently, highlighted by the significant progress advancing our ongoing Phase 2 studies of praluzatamab ravtansine and CX-2029. Patient enrollment for the Phase 2 study of praluzatamab ravtansine in breast cancer remains on track and an initial data readout is anticipated in the second half of 2022. This approaching milestone follows our recent announcement of preliminary results for CX-2029 in the treatment of squamous lung and head and neck cancers," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX. "Our progress with CX-2029, announced in December, underscores our leadership as the first company to report results from a Phase 2 study for a conditionally activated biologic and we look forward to sharing additional data from our ambitious pipeline in the second half of 2022."
Dr. McCarthy added, "2021 was also marked by considerable progress in the earlier CytomX pipeline. CX-904, our conditionally activated T-cell-engaging bispecific antibody targeting EGFR and CD3, was advanced towards a first-in-human study and, as a result, CytomX now has six investigational products in clinical development across three therapeutic modalities. We also deepened our efforts in conditionally activated cytokines, a field in which we see broad and differentiated clinical opportunity. We have entered 2022 intensely focused on pipeline execution and plan to deliver important milestones this year."
Fourth Quarter Business Highlights and Recent Developments
Praluzatamab ravtansine – Praluzatamab ravtansine is a CD166-directed conditionally activated antibody-drug conjugate (ADC) wholly-owned by CytomX. Patient enrollment continued in the three-arm Phase 2 study of praluzatamab ravtansine in breast cancer. Arms A and B are evaluating praluzatamab ravtansine, as monotherapy, in patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-non-amplified breast cancer and triple-negative breast cancer (TNBC), respectively. Arm C is examining the combination of praluzatamab ravtansine and pacmilimab, CytomX’s proprietary conditionally activated anti-PD-L1 therapeutic candidate, in patients with TNBC.
CX-2029 – CX-2029 is a CD71-directed conditionally activated ADC being co-developed by CytomX and AbbVie. Preliminary data from the Phase 2 expansion study of CX-2029 were announced in December 2021, showing an objective response rate of 18.8 percent and disease control rate of 87.5 percent in 16 efficacy-evaluable patients with sqNSCLC. The safety profile in the expansion phase was consistent with previous Phase 1 observations, with no new safety signals identified and anemia was the most common Grade 3 or higher treatment-related adverse event.
CX-904 – CX-904 is a conditionally activated T-cell-engaging bispecific antibody (TCB) targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells, and is being developed in collaboration with Amgen. In January 2022, the investigational new drug application for CX-904 was allowed to proceed by the U.S. Food and Drug Administration and CytomX is in the process of initiating a first-in-human Phase 1 study in patients with advanced solid tumors.
Ipilimumab Probody Program – BMS-986249 and BMS-986288 are Probody versions of the anti-CTLA4 antibody, ipilimumab and non-fucosylated ipilimumab, respectively. CytomX’s partner, Bristol Myers Squibb, continued to study BMS-986249 in a randomized Phase 2 study in combination with nivolumab, the anti-PD-1 antibody, versus ipilimumab plus nivolumab in patients with previously-untreated advanced melanoma. This novel combination is also being evaluated in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and TNBC. Bristol Myers Squibb also continued to evaluate BMS-986288, as monotherapy and in combination with nivolumab, in a Phase 1 study in advanced solid tumors.
Preclinical Programs – CytomX continued to work on broadening the potential application of its versatile and tunable Probody platform to other product candidates, including potential first-in-class ADCs directed toward the epithelial cell adhesion molecule (EpCAM/Trop-1) and a conditionally activated cytokine, interferon alpha-2b.
Publication – CytomX continued to publish key results supporting its platform and pipeline, taking the total preclinical and clinical manuscripts published since 2021 to seven. First-in-human data in patients with advanced solid tumors was published in February 2022 in the peer-reviewed journal Clinical Cancer Research, validating CD166, for the first time, as a potential ADC target View Source
Priorities for 2022
Initiate a Phase 1 study of CX-904 in advanced solid tumors in the first half of 2022
Continue patient enrollment in the expansion phase of the Phase 2 study of CX-2029 and provide additional data updates in the second half of 2022
Report initial data from Arms A and B in the Phase 2 study of praluzatamab ravtansine in patients with breast cancer in the second half of 2022
Fourth Quarter and Full Year 2021 Financial Results
Cash, cash equivalents and investments totaled $305.2 million as of December 31, 2021, compared to $316.1 million as of December 31, 2020.
Total revenues were $19.7 million and $69.6 million for the three and twelve months ended December 31, 2021, respectively, compared to $16.4 million and $100.4 million for the corresponding periods in 2020. The increase in total revenues during the three months ended December 31, 2021 was largely related to the CD71 collaboration with AbbVie. The decrease in total revenues for the twelve months ended December 31, 2021 was mainly due to the $40.0 million milestone payment earned in the first quarter of 2020 under the CD71 Co-Development and Licensing Agreement with AbbVie.
Research and development expenses increased by $14.6 million and $1.3 million during the three and twelve months ended December 31, 2021, respectively, to $36.6 million and $114.2 million, compared to $22.0 million and $112.9 million for the corresponding periods in 2020. The increases were primarily driven by personnel expenses, clinical trial activities, and consulting and contract services to support our pre-clinical and clinical portfolio, which, for the twelve months ended December 31, 2021, was mostly offset by a decrease in licensing expenses.
General and administrative expenses increased by $0.3 million and $3.1 million during the three and twelve months ended December 31, 2021, respectively, to $9.5 million and $39.2 million, compared to $9.1 million and $36.0 million for the corresponding periods in 2020. The increase was mainly attributable to increase in personnel related and recruiting expenses.
Conference Call & Webcast Information
CytomX management will host a conference call and a simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results and provide a business update. To join the conference call, please dial (877) 809-6037 (domestic) or (615) 247-0221 (international) and reference the conference ID 8454049. A live webcast of the call can be accessed on the Events and Presentations page of CytomX’s website at View Source An archived replay of the webcast will be available on the Company’s website until March 8, 2022.