CytomX Therapeutics Announces Full-Year 2018 Financial Results
“Over the last year, we have generated meaningful clinical proof of concept data for the Probody platform across both of our lead, wholly-owned programs,” said
2018 Business Highlights and Recent Developments
PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program
- CX-072 is a Probody therapeutic targeting PD-L1, a clinically- and commercially-validated anti-cancer target.
- Enrollment began in
January 2017in PROCLAIM-CX-072, a Phase 1/2 clinical trial evaluating CX-072 as monotherapy and in combination with YERVOY® (ipilimumab) or Zelboraf® (vemurafenib) in patients with cancer.
- Enrollment is complete with follow-up continuing in the monotherapy dose escalation arm evaluating CX-072 in patients with advanced unresectable solid tumors or lymphomas (Part A) and in the monotherapy dose escalation arm in patients with PD-L1-positive tumors (Part A2).
- Enrollment and follow-up are ongoing in the monotherapy expansion cohorts of CX-072 at 10 mg/kg in multiple indications (Part D).
- Data from Parts A, A2 and D was presented most recently at CytomX’s 2019 Research and Development Day.
- Additional data from Part D is expected in 2019.
- Enrollment of the dose escalation arm combining CX-072 plus Yervoy® (ipilimumab) in patients with advanced unresectable solid tumors or lymphomas (Part B) is complete and was presented most recently at CytomX’s 2019 Research and Development Day.
- Enrollment is ongoing in the dose escalation combination arm of CX-072 plus Zelboraf® (vemurafenib) in patients with V600E BRAF-positive melanoma (Part C).
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program
- CX-2009 is a Probody drug conjugate (PDC) that targets CD166, an antigen that is broadly and highly expressed in many types of cancer, and is conjugated with DM4, a clinically-validated toxin licensed from ImmunoGen.
- Enrollment began in
June 2017in PROCLAIM-CX-2009, a Phase 1/2 clinical trial, evaluating CX-2009 as monotherapy in a subset of seven cancer types (Part A) and in patients selected for high level of CD166 expression (Part A2).
- Preliminary data from Parts A and A2 was presented at CytomX’s 2019 Research and Development Day.
BMS-986249 (CTLA-4 Probody Therapeutic) Clinical Program
Bristol-Myers Squibb(BMS), continues enrollment in a Phase 1/2 clinical trial evaluating BMS-986249 alone and in combination with OPDIVO® (nivolumab) in solid tumors that are advanced and have spread.
- BMS has stated that they anticipate preliminary data from this trial in 2019.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program
- CytomX, in collaboration with
AbbVie, is advancing CX-2029, a CD71-directed Probody Drug Conjugate.
- CD71, also known as the transferrin receptor 1 (TfR1), is highly expressed in a number of solid and hematologic cancers and has particularly attractive molecular properties for efficient delivery of cytotoxic payloads to tumor cells.
- Enrollment began in late
June 2018in PROCLAIM-CX-2029, a Phase 1/2 clinical trial evaluating CX-2029 as monotherapy in patients with solid tumors or lymphomas and is ongoing.
CX-188 (PD-1 Probody Therapeutic) Program
- CX-188 is a PD-1-directed Probody therapeutic.
- PD-1 is the receptor for the PD-L1 ligand responsible for inhibiting T-cell activation in a variety of cancers and is a clinically- and commercially-validated anti-cancer target.
October 2018, CytomX filed an Investigational New Drug Application (IND) with the Food and Drug Administration( FDA) on CX-188. The CX-188 IND was cleared by the FDAin November 2018. Due to a recent program and portfolio prioritization, the company has decided to indefinitely postpone the CX-188 clinical trials. The company may elect to initiate clinical trials of CX-188 in the future.
CytomX Technology Acquisition from
January 2019, CytomX announced the acquisition of drug conjugate linker-toxin and CD3-based bispecific technologies from Agensys, Inc., an affiliate of Astellas Pharma Inc.
CytomX hosted a Research and Development Day on
Full Year Financial Results
Cash, cash equivalents and short-term investments totaled
Research and development expenses increased by
General and administrative expenses increased by
Teleconference Scheduled Today at
Conference Call/Webcast Information
CytomX management will host a conference call today at
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. In particular, data referenced above for CX-072 and CX-2009, including data on efficacy and safety, including treatment related adverse events, immune related adverse events and anti-drug antibodies, is based on a limited number of patients and at specific doses and, in some cases, specific cancer types. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy of CytomX’s or any of its collaborative partners’ product candidates, administered separately or in combination, CytomX’s ability and the ability of its collaborative partners to develop and advance product candidates into and successfully complete clinical trials, including CytomX’s Phase 1/2 clinical trials of CX-072, CX-2009 and CX-2029, the timing of any future clinical trials to be initiated by CytomX or any of its collaborative partners, including a clinical trial for CX-188, CytomX’s expectations regarding the availability of clinical data, including data from the ongoing clinical trial of CX-2009, CytomX’s expectations with respect to its collaborations, and CytomX’s expectations regarding the timing of potential regulatory filings. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: three of CytomX’s product candidates under its Probody platform 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; 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; CytomX’s dependence on the success of CX-072, CX-2009 and CX-2029; CytomX’s reliance on third parties for the manufacture of the company’s product candidates; and possible regulatory developments in
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
|Year Ended December 31,|
|Revenues from related parties||—||—||2,198|
|Research and development||103,866||92,277||54,755|
|General and administrative||33,510||25,605||19,874|
|Total operating expenses||137,376||117,882||74,629|
|Loss from operations||(77,874||)||(46,259||)||(59,586||)|
|Other income (expense), net||(68||)||(27||)||(69||)|
|Loss before income taxes||(70,301||)||(43,612||)||(58,919||)|
|Provision for (benefit from) income taxes||14,303||(513||)||(19||)|
|Net loss per share, basic and diluted||$||(2.03||)||$||(1.16||)||$||(1.63||)|
|Shares used to compute net loss per share, basic and diluted||41,664,382||37,166,830||36,234,732|
|Other comprehensive loss:|
|Changes in unrealized gain (losses) on investments||1||(67||)||49|
|Total comprehensive loss||$||(84,603||)||$||(43,166||)||$||(58,851||)|
(in thousands, except share and per share data)
|December 31,||December 31,|
|Cash and cash equivalents||$||247,577||$||177,548|
|Prepaid expenses and other current assets||9,251||4,352|
|Total current assets||445,475||388,601|
|Property and equipment, net||6,934||4,218|
|Intangible assets, net||1,458||1,604|
|Liabilities, Convertible Preferred Stock and Stockholders' Equity|
|Income tax payable||13,339||1|
|Deferred revenues, current portion||52,713||40,559|
|Total current liabilities||97,908||61,147|
|Deferred revenue, net of current portion||225,267||264,704|
|Other long-term liabilities||3,050||1,897|
|Commitments and contingencies|
|Convertible preferred stock, $0.00001 par value; 10,000,000 shares authorized at
December 31, 2018 and 2017; no shares issued and outstanding at
December 31, 2018 and 2017, respectively
|Common stock, $0.00001 par value; 75,000,000 shares authorized at
December 31, 2018 and 2017; 45,083,209 and 38,478,560 shares issued
and outstanding at December 31, 2018 and 2017, respectively
|Additional paid-in capital||445,956||289,454|
|Accumulated other comprehensive loss||(93||)||(94||)|
|Total stockholders' equity||130,883||69,896|
|Total liabilities, convertible preferred stock and stockholders' equity||$||457,108||$||397,644|
Investors and Media:
VP, Investor Relations and Corporate Communications
Source: CytomX Therapeutics Inc.