CytomX Therapeutics Announces First Quarter 2019 Financial Results
As of March 31, 2019, CytomX had cash, cash equivalents and short-term investments of $396.6 million.
“We continued to make excellent progress developing our differentiated technology platform and lead product candidates during the first quarter,” said
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.
- CytomX has previously presented Phase 1 clinical data from PROCLAIM-CX-072 evaluating the safety and activity of CX-072 as monotherapy and in combination with YERVOY® (ipilimumab).
• The PROCLAIM-CX-072 Monotherapy dose escalation phase is complete (Parts A and A2). Of 24 efficacy evaluable patients, all with generally weakly immunogenic tumors, and treated with doses greater than or equal to 3 mg/kg of CX-072, 12 (50%) demonstrated tumor shrinkage including four partial responses (one confirmed, 2 unconfirmed, one confirmation pending) as of the
February 6, 2019data cutoff. CX-072 as monotherapy was generally well tolerated. A maximum tolerated dose (MTD) for CX-072 monotherapy was not reached.
• The PROCLAIM-CX-072 combination dose escalation of CX-072 with ipilimumab (Part B1) is complete with the MTD defined as 3 mg/kg of ipilimumab and 10 mg/kg of CX-072. Of 19 patients evaluable for efficacy, four (21%) patients experienced confirmed responses as of the February 6, 2019 data cutoff including one complete response. Among 27 patients treated with CX-072 in combination with ipilimumab at 3 mg/kg or above, the combination was generally well tolerated. Seven (26%) patients reported a Grade 3/4 treatment-related adverse event (TRAE) and 3 (11%) patients reported a Grade 3/4 immune-related adverse event (irAE). These data compare well to historical controls and strongly support the further clinical advancement of this combination.
- Updated clinical data from monotherapy expansion cohorts (Part D) of the PROCLAIM-CX-072 program, evaluating the safety and efficacy of CX-072 in multiple tumor types at 10mg/kg, will be presented in a poster and as part of the Poster Discussion Session on
Saturday, June 1at the 2019 Annual Society of Clinical Oncology( ASCO) Annual Meeting.
• Abstract 2513 - CX-072, a PD-L1 Probody Therapeutic, as Monotherapy in Patients with Advanced Solid Tumors: Preliminary Results of PROCLAIM-CX-072
- Next steps in the further advancement of CX-072 are under development.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program
- CX-2009 is a first in class Probody drug conjugate (PDC) that targets CD166, a novel antigen that is broadly and highly expressed in many types of cancer.
- During the first quarter, CytomX presented preliminary clinical findings from PROCLAIM-CX-2009 studying CX-2009 as monotherapy in a subset of CD166 expressing cancer types, including certain patients selected for high level CD166 expression (Parts A and A2).
• As of a
February 26, 2019data snapshot, 71 patients at all doses tested were evaluable for efficacy. For patients who received ≥4 mg/kg of CX-2009 and had at least one post-baseline, on-study tumor assessment, 15/39 (38%) achieved tumor shrinkage, including seven unconfirmed partial responses observed in breast cancer, ovarian cancer and head and neck cancer. 29/39 patients (74%) achieved stable disease or better at the time of the first on-treatment scan.
• CX-2009 was generally well tolerated. The MTD was not reached at the highest dose level tested of 10 mg/kg. The most common TRAEs were grade 1 and 2 and included nausea (32%), fatigue (24%) and decreased appetite (23%). The most common grade 3/4 TRAE was keratitis (8%).
- Next steps in the further advancement of CX-2009 are under development.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program
- CD71, also known as the Transferrin Receptor, is a highly efficient cellular mechanism for the internalization of antibody drug conjugates in preclinical models.
- Given the widespread expression of CD71 on normal tissues, however, it is widely considered to be an undruggable target for clinical purposes using conventional antibody drug conjugate technology.
- CytomX discovered and is developing, in collaboration with
AbbVie, CX-2029, a CD71-directed Probody Drug Conjugate which has the potential to turn CD71 into a druggable target.
- CytomX continues to enroll patients in PROCLAIM-CX-2029, a Phase 1/2 clinical trial evaluating CX-2029 as monotherapy in patients with solid tumors or lymphomas.
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.
Technology Acquisition from
- In January, CytomX announced the acquisition of drug conjugate linker-toxin and CD3-based bispecific technologies from
Agensys, Inc., an affiliate of Astellas Pharma Inc.CytomX aims to utilize this technology in the ongoing discovery and development of novel Probody therapeutic candidates.
Appointment of New Director
- In April, CytomX announced the appointment of
Elaine V. Jones, Ph.D. to the Board of Directors, effective May 1, 2019.
First Quarter 2019 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, clinical and preclinical data referenced above for CX-072 and CX-2009, including data on efficacy and safety, including treatment related adverse events, is based on a limited dataset, including for the clinical data, 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, 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 clinical trials of CX-072 and CX-2009, and the timing of any future clinical trials to be initiated by CytomX or its collaborative partners. 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; four 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, CX-2029 and BMS 986249; CytomX’s reliance on third parties for the manufacture of the company’s product candidates; and possible regulatory developments in
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
|Three Months Ended|
|Research and development||36,376||22,458|
|General and administrative||9,674||7,356|
|Total operating expenses||46,050||29,814|
|Loss from operations||(16,565||)||(15,630||)|
|Loss before income taxes||(14,130||)||(14,395||)|
|Provision for (benefit from) income taxes||(6||)||1,098|
|Net loss per share, basic and diluted||$||(0.31||)||$||(0.40||)|
|Shares used to compute net loss per share, basic and diluted||45,122,456||38,647,878|
|Other comprehensive income (loss):|
|Changes in unrealized gain (loss) on short-term investments, net of tax||155||(134||)|
|Impact of adoption of new accounting pronouncement||11||—|
CONDENSED BALANCE SHEETS
(in thousands, except share and per share data)
|March 31,||December 31,|
|Cash and cash equivalents||$||190,407||$||247,577|
|Prepaid expenses and other current assets||8,437||9,251|
|Total current assets||405,077||445,475|
|Property and equipment, net||7,369||6,934|
|Intangible assets, net||1,422||1,458|
|Operating lease right-of-use||27,404||—|
|Liabilities and Stockholders' Equity|
|Income tax payable||13,374||13,339|
|Deferred revenue, current portion||50,765||52,713|
|Total current liabilities||96,217||97,908|
|Deferred revenue, net of current portion||197,754||225,267|
|Operating lease liabilities - long term||27,008||—|
|Other long-term liabilities||963||3,050|
|Commitments and contingencies|
|Convertible preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued and outstanding at March 31, 2019 and December 31, 2018.||—||—|
|Common stock, $0.00001 par value; 75,000,000 shares authorized; 45,157,652 and 45,083,209 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively||1||1|
|Additional paid-in capital||451,613||445,956|
|Accumulated other comprehensive income (loss)||73||(93||)|
|Total stockholders' equity||122,571||130,883|
|Total liabilities and stockholders' equity||$||444,513||$||457,108|
(1) The condensed balance sheet as of
VP, Investor Relations and Corporate Communications
Source: CytomX Therapeutics Inc.