CytomX Therapeutics Announces 2025 Financial Results and Provides Business Update
- Announced Positive Data from Phase 1 Dose Expansion Study of varsetatug masetecan (“Varseta-M”) EpCAM PROBODY® ADC in Patients with Advanced Colorectal Cancer (CRC) -
- FDA interactions targeted for mid-year with goal to align on potential Varseta-M registrational trial design in late line CRC -
- Varseta-M Phase 1 study evaluating combination with bevacizumab initiated; Phase 1b/2 chemotherapy combination study to be initiated by the end of 2026 -
- Initial CX-801 PROBODY Interferon-alpha-2b Phase 1 combination data with KEYTRUDA® (pembrolizumab) in melanoma expected by the end of 2026 -
- Company to host conference call today at
“Today’s encouraging Varseta-M Phase 1 update underscores the program’s intentional design and broad potential in CRC as well as other EpCAM-expressing indications. CytomX’s top priority in 2026 is to align with the FDA on a registrational path for Varseta-M in late-line CRC. We also plan to accelerate Varseta-M combination studies to benefit CRC patients in earlier lines of treatment,” said
“Our continued and exciting progress with Varseta-M reinforces our leadership in the field of masking and CytomX’s ability to unlock true innovation. Our highly focused portfolio strategy is also illustrated by our second clinical program, CX-801. This masked version of Interferon-alpha-2b is being developed initially in advanced melanoma and, we believe, has the potential to become a new centerpiece of combination immunotherapy across multiple cancers. The CX-801 translational and biomarker data presented to date have been very encouraging, and we expect to share initial proof of concept data for the combination with KEYTRUDA® later this year.”
Pipeline Program Updates:
Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051)
- Announced positive data update from Phase 1 dose expansion study of Varseta-M in patients with advanced colorectal cancer (CRC).
- The Company aims to align with the FDA in 2026 on a potential registrational study design for Varseta-M monotherapy in advanced CRC.
- Additional Phase 1 follow-up data are also expected to be presented at major medical meeting(s) in 2026.
- A Phase 1 Varseta-M combination study with bevacizumab in CRC has been initiated and a Phase 1b/2 study in combination with bevacizumab and chemotherapy is expected to start by the end of 2026.
- Initiation of Phase 1 expansion cohort(s) in additional indications is planned for 2H 2026.
CX-801 (PROBODY Interferon alpha-2b)
- The CX-801 Phase 1 study is progressing with a focus in advanced melanoma. The CX-801 monotherapy dose escalation portion of the study has reached the fourth dose level.
- CX-801 monotherapy has been well tolerated at dose levels exceeding the approved dose of unmasked IFNα2b.1
- In
May 2025 , Phase 1 dose escalation of CX-801 in combination with KEYTRUDA® (pembrolizumab) was initiated. Dose escalation of CX-801 in combination with KEYTRUDA® is currently enrolling the 2nd dose level. - Biomarker data from the CX‑801 monotherapy study in advanced melanoma were presented at the 2025
Society for Immunotherapy of Cancer (SITC) Annual Meeting, reinforcing CX‑801’s mechanism of action and supporting the ongoing combination trial with KEYTRUDA®. - Initial clinical data for CX-801 in combination with KEYTRUDA® in advanced melanoma is projected by the end of 2026.
KEYTRUDA® is a registered trademark of
Corporate and Financial:
- Financial:
- CytomX ended 2025 with
$137.1 million of cash, cash equivalents and investments with expected cash runway to the second quarter of 2027.
- CytomX ended 2025 with
- Research Pipeline and Collaborations:
- CytomX has research collaborations with Bristol Myers Squibb, Amgen, Regeneron, and Moderna. Multiple drug discovery programs continue across our research collaborations with a focus on bispecific immunotherapies, including T-cell engagers.
- In
March 2026 , Astellas chose to not advance the remaining preclinical research programs under the alliance resulting in a termination of the collaboration effective in the second quarter of 2026.
Full Year 2025 Financial Results:
Cash, cash equivalents and investments totaled
Total revenue was
In 2025, CytomX remained focused on controlling costs and efficiently progressing its pipeline programs. Total operating expense for 2025 was
Research and development expenses decreased by
General and administrative expenses increased by
About
CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, masked PROBODY® therapeutics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), cytokines and T-cell engagers. CytomX’s clinical-stage pipeline includes varsetatug masetecan (Varseta-M; CX-2051) and CX-801. Varseta-M is a masked, conditionally activated ADC armed with a topoisomerase-1 inhibitor payload and directed toward epithelial cell adhesion molecule (EpCAM). EpCAM is a highly expressed tumor antigen that has previously been undruggable due to expression on normal tissues. Varseta-M is designed to open a therapeutic window for this high potential target and is initially being developed for the treatment of metastatic colorectal cancer. Varseta-M was discovered in collaboration with ImmunoGen, now part of AbbVie. CX-801 is a masked interferon alpha-2b PROBODY® cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CX-801 is initially being developed for the treatment of metastatic melanoma. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and X (formerly Twitter).
CytomX Therapeutics Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond CytomX’s control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to the future potential of partnerships or collaboration agreements and projected cash runway. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including varsetatug masetecan (Varseta-M; CX-2051) and CX-801, the potential benefits or applications of CytomX’s PROBODY® therapeutic platform, CytomX's planned interactions with the
PROBODY is a
Company Contact:
SVP, Chief Financial Officer
cogden@cytomx.com
Investor Contact:
Precision AQ
Stephanie.Ascher@precisionaq.com
Media Contact:
Precision AQ
Colleen.ketchum@precisionaq.com
BALANCE SHEETS (in thousands, except share and per share data) |
||||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 12,667 | $ | 38,052 | ||||
| Short-term investments | 124,385 | 62,571 | ||||||
| Accounts receivable | 2,013 | 3,103 | ||||||
| Prepaid expenses and other current assets | 4,856 | 3,579 | ||||||
| Total current assets | 143,921 | 107,305 | ||||||
| Property and equipment, net | 1,304 | 2,467 | ||||||
| Intangible assets, net | 438 | 583 | ||||||
| 949 | 949 | |||||||
| Restricted cash | 1,527 | 1,027 | ||||||
| Operating lease right-of-use asset | 3,396 | 8,136 | ||||||
| Other assets | 31 | 66 | ||||||
| Total assets | $ | 151,566 | $ | 120,533 | ||||
| Liabilities and Stockholders' Equity (Deficit) | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,301 | $ | 1,088 | ||||
| Accrued liabilities | 14,197 | 12,338 | ||||||
| Operating lease liabilities - short term | 4,240 | 5,145 | ||||||
| Deferred revenue, current portion | 26,877 | 67,201 | ||||||
| Total current liabilities | 46,615 | 85,772 | ||||||
| Deferred revenue, net of current portion | 1,590 | 26,862 | ||||||
| Operating lease liabilities - long term | — | 4,240 | ||||||
| Other long-term liabilities | 4,353 | 4,115 | ||||||
| Total liabilities | 52,558 | 120,989 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity (deficit) | ||||||||
| Convertible preferred stock | — | — | ||||||
| Common stock | 2 | 1 | ||||||
| Additional paid-in capital | 810,844 | 691,095 | ||||||
| Accumulated other comprehensive income | 111 | 27 | ||||||
| Accumulated deficit | (711,949 | ) | (691,579 | ) | ||||
| Total stockholders' equity (deficit) | 99,008 | (456 | ) | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 151,566 | $ | 120,533 | ||||
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (in thousands, except share and per share data) |
||||||||
| Year Ended |
||||||||
| 2025 | 2024 | |||||||
| Revenues | $ | 76,201 | $ | 138,103 | ||||
| Operating expenses: | ||||||||
| Research and development | 68,728 | 83,382 | ||||||
| General and administrative | 29,837 | 29,726 | ||||||
| Total operating expenses | 98,565 | 113,108 | ||||||
| Income (loss) from operations | (22,364 | ) | 24,995 | |||||
| Interest income | 5,206 | 7,136 | ||||||
| Other income (expense), net | 28 | (38 | ) | |||||
| Income (loss) before income taxes | (17,130 | ) | 32,093 | |||||
| Provision for income taxes | 238 | 224 | ||||||
| Net income (loss) | (17,368 | ) | 31,869 | |||||
| Deemed dividend on warrants | (3,002 | ) | — | |||||
| Net income (loss) attributable to common stockholders | $ | (20,370 | ) | $ | 31,869 | |||
| Other comprehensive income (loss): | ||||||||
| Unrealized gain (loss) on available-for-sale investments, net of tax | 84 | (68 | ) | |||||
| Total comprehensive income (loss) | $ | (17,284 | ) | $ | 31,801 | |||
| Net income (loss) per share: | ||||||||
| Basic | $ | (0.15 | ) | $ | 0.38 | |||
| Diluted | $ | (0.15 | ) | $ | 0.38 | |||
| Weighted average common shares used to compute net income (loss) per share | ||||||||
| Basic | 137,935,873 | 84,439,303 | ||||||
| Diluted | 137,935,873 | 84,745,116 | ||||||
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1 Merck & Co., Inc. (2018). Sylatron (peginterferon alfa-2b) prescribing information.
Source: CytomX Therapeutics Inc.
