CytomX Therapeutics Announces Second Quarter 2021 Financial Results and Provides Business Update
“In the second quarter of 2021, we continued to advance our broad pipeline of Probody therapeutics across multiple modalities and cancer types. Our Phase 2 studies, evaluating our two lead conditionally activated antibody-drug conjugates, praluzatamab ravtansine (CX-2009), targeting CD166, and CX-2029, targeting CD71, are ongoing,” said
Business Highlights and Recent Developments
- Patient enrollment is ongoing in the Phase 2 study of praluzatamab ravtansine (CX-2009), our wholly-owned CD166-directed conditionally activated antibody-drug conjugate (ADC), being evaluated as a monotherapy in patients with human epidermal growth factor receptor 2-non-amplified breast cancer and in combination with pacmilimab (CX-072), in patients with triple-negative breast cancer. Due primarily to impacts from the COVID-19 pandemic, including slower clinical site activation and patient enrollment, CytomX now anticipates initial data from this study in 2022.
- In collaboration with AbbVie, the multi-cohort Phase 2 study of CX-2029, the CD71-directed conditionally activated ADC, continues to enroll patients into the expansion cohorts evaluating the following indications: squamous non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal and gastro-esophageal junction cancers, and diffuse large B-cell lymphoma. Initial data from this study is anticipated in the fourth quarter of 2021.
- Our collaboration partner, Bristol Myers Squibb, continues to study the combination of BMS-986249, a Probody version of ipilimumab, and nivolumab, the anti-PD-1 antibody, in four cancer types: metastatic melanoma, advanced hepatocellular carcinoma, metastatic castration-resistant prostate cancer, and advanced triple-negative breast cancer. Bristol Myers Squibb is also evaluating BMS-986288, a Probody version of non-fucosylated ipilimumab, as monotherapy or in combination with nivolumab, in a Phase 1 study.
- CytomX submitted a pre-investigational new drug application (IND) meeting request to the
U.S. Food and Drug Administration (FDA) for CX-904 in collaboration with Amgen and expects a written response from the FDA in the third quarter of 2021. CytomX will continue to discuss the program with Amgen and is working toward the filing of an IND in late 2021. - Ongoing research and pre-clinical development activities continue, towards the generation of conditionally activated cytokine therapeutics for the treatment of cancer, including interferon alpha-2b.
- Five peer-reviewed manuscripts have been published highlighting progress across the CytomX pipeline and platform:
- Pacmilimab (CX-072):
- First-in-human biodistribution study using positron emission tomography imaging in
Clinical Cancer Research . This is the first human clinical imaging report of a Probody therapeutic and further supports mechanistic aspects of platform performance including target engagement in the tumor and reduced target engagement in normal tissues. This article can be accessed using this link. - First-in-human monotherapy study in patients with advanced solid tumors in the
Journal for ImmunoTherapy of Cancer . In this study, pacmilimab demonstrated single-agent activity in advanced solid tumors, including metastatic triple-negative breast cancer. This article can be downloaded using this link. - First-in-human study in combination with ipilimumab, the anti-cytotoxic T lymphocyte-associated antigen-4 antibody, in advanced solid tumors, also in the
Journal for ImmunoTherapy of Cancer . The combination of pacmilimab and ipilimumab illustrates the potential for pacmilimab as a preferred checkpoint inhibitor for combination therapies. This article can be downloaded using this link.
- First-in-human biodistribution study using positron emission tomography imaging in
- CX-2029
- First-in-human data in patients with advanced solid tumors in the peer-reviewed journal
Clinical Cancer Research , demonstrating, for the first time, that CD71 can be a therapeutic cancer target for a masked drug-conjugated antibody . This article can be downloaded using this link.
- First-in-human data in patients with advanced solid tumors in the peer-reviewed journal
- Preclinical:
- Preclinical studies of a novel Probody immuno-oncology agent targeting CD137 in Proceedings of the
National Academy of Sciences . This is the first published application of the CytomX platform to agonist antibodies in immuno-oncology. This article can be accessed using this link.
- Preclinical studies of a novel Probody immuno-oncology agent targeting CD137 in Proceedings of the
- Pacmilimab (CX-072):
Second Quarter 2021 Financial Results
Cash, cash equivalents and short- and long-term investments totaled
Revenue was
Research and development expenses increased
General and administrative expenses were
Conference Call & Webcast Information
CytomX management will host a conference call today at
About CytomX Therapeutics
CytomX is a clinical-stage, oncology-focused biopharmaceutical company with a vision of transforming lives with safer, more effective therapies. We are developing a novel class of investigational conditionally activated therapeutics, based on our Probody® technology platform, for the treatment of cancer. CytomX has strategic drug discovery and development collaborations with AbbVie, Amgen, Astellas, and Bristol Myers Squibb.
Probody therapeutics are conditionally activated biologics designed to remain inactive until they are activated by proteases in the tumor microenvironment. As a result, Probody therapeutics are intended to bind selectively to tumors and decrease binding to healthy tissue, to minimize toxicity and potentially create safer, more effective therapies. As leaders in the field, our innovative technology is designed to turn previously undruggable targets into druggable targets and to enable more effective combination therapies. CytomX and its partners, comprised of leading biotechnology and pharmaceutical companies, have developed a robust pipeline of potential first-in-class therapeutic candidates against novel, difficult to drug targets and potential best-in-class immunotherapeutic candidates against clinically validated targets. The CytomX clinical-stage pipeline comprises five assets, four of which are in Phase 2 clinical studies. First-in-class product candidates against previously undruggable targets include a CD166-targeting conditionally activated antibody-drug conjugate wholly owned by CytomX (praluzatamab ravtansine, CX-2009) and a CD71-targeting conditionally activated antibody-drug conjugate partnered with AbbVie (CX-2029). CD166 and CD71 are among cancer targets that are considered to be inaccessible to conventional antibody-drug conjugates due to their presence on many healthy tissues. The CytomX clinical-stage pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probodies, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, and our wholly-owned conditionally activated anti-PD-L1 antibody, pacmilimab (CX-072). For additional information about
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 our 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. 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 praluzatamab ravtansine (CX-2009), CX-2029, BMS-986249, BMS-986288, and pacmilimab (CX-072), the potential benefits or applications of CytomX’s Probody platform technology, CytomX’s ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of praluzatamab ravtansine, CX-2029, BMS-986249, BMS-986288, and pacmilimab, and the timing of the commencement of clinical trials, initial data and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel Probody Platform technology; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the business, research and clinical operations of CytomX or its partners, including the development of preclinical drug candidates due to delays in and disruption of research activities and the development of clinical drug candidates due to delays in or disruption of clinical trials, including impacts on the enrollment of patients in clinical trials or other clinical trial disruptions; the possibility that the results of early clinical trials may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of praluzatamab ravtansine, CX-2029, BMS-986249, BMS-986288, and pacmilimab; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; and possible regulatory developments in the United States and foreign countries. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on August 5, 2021. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
Probody is a
Investor Contact:
VP, Investor Relations & Corp. Communications
ccheng@cytomx.com
Direct: (650) 273-4999
Media Contact:
Director, Corporate Communications
bcoons@cytomx.com
Direct: (650) 528 2929
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(Unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Revenues | $ | 16,288 | $ | 16,608 | $ | 32,259 | $ | 66,201 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 26,100 | 24,066 | 48,472 | 66,880 | ||||||||||||
General and administrative | 9,393 | 8,680 | 18,619 | 18,252 | ||||||||||||
Total operating expenses | 35,493 | 32,746 | 67,091 | 85,132 | ||||||||||||
Loss from operations | (19,205 | ) | (16,138 | ) | (34,832 | ) | (18,931 | ) | ||||||||
Interest income | 44 | 454 | 112 | 1,530 | ||||||||||||
Other income (expense), net | (82 | ) | 5 | (77 | ) | 16 | ||||||||||
Loss before income taxes | (19,243 | ) | (15,679 | ) | (34,797 | ) | (17,385 | ) | ||||||||
Benefit from income taxes | — | — | — | (13,911 | ) | |||||||||||
Net loss | $ | (19,243 | ) | $ | (15,679 | ) | $ | (34,797 | ) | $ | (3,474 | ) | ||||
Net loss per share, basic and diluted | $ | (0.30 | ) | $ | (0.34 | ) | $ | (0.55 | ) | $ | (0.08 | ) | ||||
Shares used to compute net loss per share, basic and diluted | 65,055,998 | 46,057,063 | 63,023,349 | 45,890,510 | ||||||||||||
Other comprehensive income (loss): | ||||||||||||||||
Unrealized gain (loss) on investments, net of tax | 58 | (320 | ) | 62 | (41 | ) | ||||||||||
Comprehensive loss | $ | (19,185 | ) | $ | (15,999 | ) | $ | (34,735 | ) | $ | (3,515 | ) | ||||
CONDENSED BALANCE SHEETS
(in thousands, except share and per share data)
2021 | 2020 | |||||||
(Unaudited) | (1) | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 256,146 | $ | 191,859 | ||||
Short-term investments | 10,031 | 124,260 | ||||||
Accounts receivable | 931 | 798 | ||||||
Prepaid expenses and other current assets | 3,897 | 7,096 | ||||||
Total current assets | 271,005 | 324,013 | ||||||
Long-term investments | 99,914 | — | ||||||
Property and equipment, net | 6,699 | 6,950 | ||||||
Intangible assets, net | 1,094 | 1,167 | ||||||
949 | 949 | |||||||
Restricted cash | 917 | 917 | ||||||
Operating lease right-of-use asset | 20,961 | 22,495 | ||||||
Other assets | 901 | 2,172 | ||||||
Total assets | $ | 402,440 | $ | 358,663 | ||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,755 | $ | 2,996 | ||||
Accrued liabilities | 19,253 | 23,059 | ||||||
Deferred revenue, current portion | 72,369 | 74,869 | ||||||
Total current liabilities | 93,377 | 100,924 | ||||||
Deferred revenue, net of current portion | 158,189 | 186,261 | ||||||
Operating lease liabilities - long term | 19,921 | 21,675 | ||||||
Total liabilities | 271,487 | 308,860 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Convertible preferred stock, |
— | — | ||||||
Common stock, |
1 | 1 | ||||||
Additional paid-in capital | 615,849 | 499,964 | ||||||
Accumulated other comprehensive income (loss) | 15 | (47 | ) | |||||
Accumulated deficit | (484,912 | ) | (450,115 | ) | ||||
Total stockholders' equity | 130,953 | 49,803 | ||||||
Total liabilities and stockholders' equity | $ | 402,440 | $ | 358,663 | ||||
__________________
(1) The condensed balance sheet as of
Source: CytomX Therapeutics Inc.