On March 27, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported full year 2022 financial results and provided a business update (Press release, CytomX Therapeutics, MAR 27, 2023, View Source [SID1234629369]).
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"2022 was an important year of transition for CytomX as we proactively restructured our organization to maximize long-term success and value creation. We entered 2023 with considerable momentum across our therapeutic pipeline including our first Probody T-cell bispecific in the clinic and preparing for two new, wholly-owned IND filings anticipated this year. We continue to optimize and leverage our leading Probody platform to create high impact therapeutic candidates with the potential to maximize overall benefit for patients. With our recently announced collaborations with Moderna and Regeneron, we are further extending the reach of our science, broadening our pipeline, and bringing important non-dilutive capital into the company. These accomplishments underscore our leadership in conditionally activated, localized biologic therapies and we look forward to a year of strong execution in 2023 that will also include a reassessment of our CX-2029 and CD71 strategy following AbbVie’s decision not to further advance the program," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics.
Fourth Quarter Business Highlights and Recent Developments
CX-904, T-cell-engaging bispecific (TCB) EGFRxCD3, Phase 1 clinical study ongoing – CX-904 is a conditionally activated TCB designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment. CX-904 is being evaluated by CytomX in an ongoing Phase 1 study in patients with advanced solid tumors. The first patient was dosed in May 2022 and the dose escalation portion of the study continues to advance and is now in the 3+3 stage having successfully completed initial single patient cohorts. The continued progression of CX-904 is a key priority for the company in 2023 with the primary goal of assessing safety and determining a recommended dose, or doses, for subsequent expansions in select tumor types. This program is partnered with Amgen in a global co-development alliance with CytomX retaining the right to opt into a profit share in the U.S.
IND filings anticipated in 2H 2023 for Wholly Owned CX-801, Interferon (IFN) alpha-2b, and CX-2051, EpCAM-directed ADC – For CytomX’s next generation molecules, the company has selected the previously validated anti-cancer targets, EpCAM and IFNa2b, respectively, that have been limited in their potential due to systemic toxicities. In the molecular design of CX-2051 and CX-801, we have incorporated our platform expertise and clinical learnings to optimize predicted therapeutic index in order to potentially broaden the clinical utility of these promising agents through localization to the tumor microenvironment. CytomX anticipates filing INDs for both programs in the second half of 2023.
BMS advancement of BMS-986288 to Phase 2 – In February 2023, BMS published pipeline updates that included moving the Anti-CTLA-4 non-fucosylated Probody, BMS-986288, from Phase 1 to Phase 2. BMS prioritized the BMS-986288 Probody program over the other two molecules in its CTLA-4 pipeline – the Probody, BMS-986249, and the antibody, BMS-986218.
CX-2029: Updated Phase 2 data and next steps – CX-2029 is a conditionally activated ADC directed toward CD71, the transferrin receptor. In January 2023, updated Phase 2 results were announced from the cohort expansion study which included squamous esophageal cancer, squamous non-small cell lung cancer (sqNSCLC), and head and neck squamous cell carcinoma (HNSCC). The Phase 2 data demonstrated encouraging clinical activity in unselected, heavily pre-treated patients with tumors of squamous histology including a 21% objective response rate (ORR) in squamous esophageal cancer and a 10% ORR in squamous non-small cell lung cancer (sqNSCLC). The adverse event (AE) profile was consistent with Phase 1 observations with anemia (82.6% all grade, 76.1% grade 3+) being the most common treatment related adverse event (TRAE). On March 21, 2023, AbbVie notified the company that it would not advance CX-2029 into additional clinical studies and provided notice of termination of the 2016 CD71 License and Collaboration Agreement. As a result of the termination, CytomX will regain full rights to CD71 and has an exclusive option to re-acquire full rights to CX-2029. CytomX will evaluate potential next steps for CX-2029 as well as pursue next-generation strategies for targeting CD71. CytomX and AbbVie have also concluded their research activities under a 2016 Discovery License and Collaboration Agreement.
Clinical candidate milestone achievement in Astellas TCB collaboration – In January 2023, Astellas nominated a collaboration clinical candidate, the first Probody TCB molecule to progress in the alliance, triggering a $5 million dollar milestone payment to CytomX. CytomX and Astellas are collaborating on additional conditionally activated TCB programs, and CytomX is eligible to receive future preclinical, clinical, and commercial milestones. CytomX retains a cost share and co-commercialization option on a select number of targets.
New strategic research collaboration with Moderna – In December 2022, CytomX entered a collaboration and licensing agreement to create investigational mRNA-based conditionally activated therapies utilizing Moderna’s mRNA technologies and CytomX’s Probody therapeutic platform. The research collaboration will leverage core scientific advances at Moderna and CytomX with the strategy of encoding potent, masked biologics with mRNA, for the potential treatment of oncology and non-oncology conditions. CytomX received an upfront payment of $35 million, including $5 million of pre-paid research funding, and is eligible to receive up to approximately $1.2 billion in future development, regulatory, and commercial milestone payments, along with tiered royalties on global net sales of any products that are commercialized under the agreement. Moderna has the option to participate in a future CytomX equity financing, subject to certain terms, conditions and regulatory requirements.
New strategic research collaboration with Regeneron – In November 2022, CytomX entered its collaboration with Regeneron to enable the development of investigational next-generation bispecific immunotherapies using CytomX’s Probody and Regeneron’s Veloci-Bi platforms. The Probody platform has the potential to widen the therapeutic window and minimize on-target, off-tumor effects for these next-generation T-cell engaging therapies, potentially addressing tumor types that have historically been unresponsive to immunotherapy. CytomX received a $30 million upfront payment in December 2022 and is eligible for up to approximately $2 billion in research, development, regulatory and sales-based milestones.
Priorities for 2023
CX-904 (EGFRxCD3): Continue patient enrollment and dose escalation in ongoing Phase 1 study
File 2 New INDs (wholly-owned): CX-801 (IFNa2b) and CX-2051 (EpCAM) projected in the second half of 2023
CX-2029 (CD71 ADC): Determine next steps for CD71 program, including CX-2029
Next-Generation CTLA-4 Program: Continued clinical progress for BMS-986288
Collaborations: Initiation of R&D activities with our newest collaborators, Regeneron and Moderna, and ongoing activities with Astellas, Amgen and BMS
Full Year 2022 Financial Results
Cash, cash equivalents and investments totaled $194 million as of December 31, 2022, compared to $305 million as of December 31, 2021 and $194 million as of September 30, 2022. The cash balance at December 31, 2022 includes the $30 million upfront payment received under the Regeneron agreement, but excludes the $35 million cash payment received under the Moderna agreement in the first quarter of 2023.
Total revenue was $53.2 million for the year ended December 31, 2022, compared to $37.3 million in 2021. The increase in revenue was driven by higher estimated percentages of completion for the research and development programs in the company’s collaborations with AbbVie, Astellas and Bristol Myers Squibb, partially offset by decreased revenue under the Amgen Agreement driven by a lower estimated percentage of completion for the CX-904 program due to an increase in the projected hours-to-completion.
Research and development expenses decreased by $2.5 million during year ended December 31, 2022, to $111.6 million compared to $114.2 million in 2021. The decrease in research and development expenses was driven by a decrease in clinical trial and lab contract services for CX-2009, CX-072, CX-2029, CX-904 and pre-clinical programs, offset by $5.3 million of restructuring expenses.
General and administrative expenses increased by $3.6 million during the year ended December 31, 2022 to $42.8 million compared to $39.2 million in 2021 primarily driven by $2.4 million of restructuring expenses and a $1.0 million increase in professional expenses related to new collaboration agreements.
Overall expenses related to the company restructuring announced in July 2022 were $7.7 million consisting primarily of employee-related expenses and severance benefits. The restructuring is substantially complete as of December 31, 2022.
On March 27, 2023, CytomX Therapeutics, Inc. filed an amended 2021 Annual Report on Form 10-K/A which included restated financial statements for the years ended December 31, 2019, 2020, and 2021 and the quarterly periods for 2020 and 2021. CytomX’s 2022 Annual Report on Form 10-K includes restated interim information for the 2022 quarterly periods. Please refer to the 2021 Form 10-K/A and 2022 Form 10-K for a full description of the restatement and the corresponding financials.
The financial results contained in this press release reflect the restated financial statements in CytomX’s most recent SEC filings.
Conference Call & Webcast
CytomX management will host a conference call and simultaneous webcast today at 5 p.m. ET (2 p.m. PT) to discuss the financial results and provide a business update. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the Company’s website.