On August 8, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported second quarter 2024 financial results and provided a business update (Press release, CytomX Therapeutics, AUG 8, 2024, View Source [SID1234645594]).

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"We are encouraged by the initial CX-904 Phase 1a data we shared in the second quarter that demonstrated single agent anti-cancer activity and a favorable therapeutic window for the high potential and previously undruggable target combination of EGFR and CD3, underscoring the potential of our PROBODY therapeutic platform," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

"Based on our clinical observations for CX-904 to date, patient enrollment is now principally focused in pancreatic cancer, where we have already shown confirmed partial responses, and in non-small cell lung cancer and head and neck cancer. We are highly focused on generating additional data during the second half of 2024 and look forward to ongoing strategic dialogue with our global development partner Amgen."

"During the second quarter we also made rapid progress in early Phase 1 dose escalation for CX-2051 and have reached our third dose level, keeping us on track for initial data to be shared externally in the first half of 2025. Also during the second quarter, we opened our first clinical site for CX-801, setting the stage for multiple clinical data readouts over the next 12 to 18 months from our multi-modality, differentiated PROBODY therapeutic pipeline," continued Dr. McCarthy.

Second Quarter Business Highlights and Recent Developments

Pipeline

CX-904, PROBODY T-cell-engager (TCE) targeted to EGFRxCD3; ongoing enrollment into Phase 1a dose escalation continues focused in PDAC, NSCLC, and HNSCC.

In May 2024, the Company announced (Link) positive initial Phase 1 dose escalation data in 35 heavily pre-treated patients (median of 4 prior lines of therapy) with advanced metastatic solid tumor types that are generally known to express EGFR. CX-904 demonstrated a favorable and manageable safety profile and initial signs of anti-tumor activity, including 2 of 6 (33%) efficacy-evaluable pancreatic cancer patients with confirmed partial responses per RECIST 1.1 and translational data supporting the CX-904 mechanism of action.
CX-904 Phase 1a dose escalation continues, with future enrollment focused in PDAC, HNSCC and NSCLC and on determining a recommended Phase 1b dose or doses.
CX-2051, an EpCAM-directed PROBODY antibody drug conjugate; Phase 1 dose escalation continues, initial data expected in 2025.

In April 2024, the first patient was dosed as part of the Phase 1 dose escalation study of CX-2051 in patients with solid tumors generally known to express EpCAM.
The third cohort has been opened in the Phase 1 study and dose escalation continues with initial enrollment focused primarily in CRC.
CX-801, PROBODY interferon-alpha 2b; Phase 1a dose escalation study initiated.

The first clinical site has been activated in the CX-801 Phase 1 dose escalation study in patients with solid tumors including melanoma, renal, and head and neck squamous cell carcinoma. The Phase 1 study will evaluate safety and signs of clinical activity for CX-801 monotherapy and for CX-801 in combination with KEYTRUDA.
In April 2024, the Company announced a clinical collaboration agreement with Merck to supply KEYTRUDA for combination with CX-801 in the Phase 1 study.
CytomX continues to make progress in its R&D partnerships.

CytomX has multiple active research and development partnerships and more than 10 ongoing research programs with major biotechnology and pharmaceutical companies (Amgen, Astellas, Bristol Myers Squibb, Moderna, and Regeneron).
In 2024 to-date, CytomX has achieved $10.0 million in preclinical milestones under its multi-target T-cell Engager collaboration with Astellas related to two separate PROBODY TCE programs.
Corporate

Chris Ogden promoted to Chief Financial Officer.

Mr. Ogden joined CytomX in August of 2021 as Vice President, Finance and Accounting and has since served in roles of increasing responsibility spanning finance, accounting, investor relations, capital raising, information technology, and facilities, most recently as Senior Vice President, Finance and Accounting. Mr. Ogden joined CytomX after a 16-year tenure at Eli Lilly and Company, where he held senior financial leadership positions, including most recently as chief financial officer of Lilly Diabetes.

Priorities and Key Milestones:

CX-904 (EGFRxCD3):
Continued Phase 1a dose escalation in PDAC, HNSCC and NSCLC focused on the selection of recommended Phase 1b dose(s)
Ongoing strategic dialogue with CytomX partner, Amgen
A CX-904 Phase 1 program update is expected by the end of 2024, including a potential decision to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types
CX-2051 (EpCAM):
Continued Phase 1 dose escalation in solid tumors, primarily CRC
Initial Phase 1a data expected in the first half of 2025
CX-801 (IFNα2b):
Continued Phase 1 dose escalation progress in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma
Initial Phase 1a data expected in the second half of 2025
Q2 2024 Financial Results

Cash, cash equivalents and investments totaled $137.2 million as of June 30, 2024, compared to $150.3 million as of March 31, 2024. Cash inflows in the quarter included $10.0 million from milestone payments earned in the Astellas collaboration and $4.8 million of proceeds raised through our At-the-market (ATM) facility. Operational cash uses in the quarter included a one-time milestone payment of $5.0 million to AbbVie (formerly ImmunoGen) for the Phase 1 initiation of CX-2051.

Total revenue was $25.1 million for the three months ended June 30, 2024 compared to $24.7 million for the corresponding period in 2023. The increase in revenue was driven primarily by a higher percentage of completion of research activities related to the Regeneron and Moderna collaborations.

Research and development expenses increased by $4.5 million for the three months ended June 30, 2024 to $25.2 million, compared to $20.7 million for the corresponding period of 2023. This was primarily due to the milestone payment to AbbVie (formerly ImmunoGen) related to the Phase 1 initiation of CX-2051.

General and administrative expenses increased by $1.0 million for the three months ended June 30, 2024 to $8.4 million compared to $7.4 million for the corresponding period of 2023, primarily due to higher consulting services, personnel costs, and intellectual property related expenses.

Conference Call & Webcast
CytomX management will host a conference call and simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) 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.