CytomX Announces Third Quarter 2017 Financial Results and Operational Progress
"We have continued to enjoy a highly productive year with excellent progress in advancing our deep pipeline of potentially transformative Probody therapeutics and the addition of another major partner in
Q3'17 BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS
PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program
- Patient enrollment continued in the monotherapy dose escalation arm (Part A1) of the study evaluating CX-072 in patients with advanced unresectable solid tumors or lymphomas. Enrollment is expected to be complete by year-end.
- Patient enrollment has now been initiated in all other dose escalation arms of the study:
- Monotherapy expansion in patients with PD-L1-positive tumors at multiple dose levels (Part A2);
- Concomitant schedule for CX-072 plus ipilimumab in patients with advanced unresectable solid tumors or lymphomas (Part B1);
- Phased schedule for CX-072 plus ipilimumab in patients with advanced unresectable solid tumors or lymphomas (Part B2); and
- Combination of CX-072 plus vemurafinib in patients with V600E BRAF-positive melanoma (Part C)
- During the first half of 2018, an expansion cohort of the study at the recommended Phase 2 dose is expected to begin enrolling patients to evaluate CX-072 as monotherapy in a tumor type with known sensitivity to PD-L1 and/or PD-1 inhibitors (Part D).
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program
- CX-2009 is a first-in-class Probody drug conjugate (PDC) that targets CD166, an antigen that is broadly and highly expressed in many types of cancers, but has been considered undruggable given that it is also expressed in normal tissue.
- Patient enrollment continues in the PROCLAIM-CX-2009 study, a Phase 1/2 clinical trial evaluating CX-2009 as monotherapy in a subset of CD166-positive cancers.
- The study was initiated at a dose of 0.25 mg/kg, has advanced through several patient cohorts and is currently enrolling at a dose of 2 mg/kg.
- Expansion cohorts at the recommended Phase 2 dose in one or more CD166 positive tumor types are expected to initiate in 2018.
CX-2029 (CD71 Probody Drug Conjugate) Preclinical Program
- CytomX, in collaboration with
AbbVie, is advancing CX-2029, a CD71-directed PDC, through Investigational New Drug (IND) application-enabling studies and expects to file an IND application in the first half of 2018.
$15 millionmilestone payment ( $14 millionnet of associated license fees) was received from AbbViein conjunction with meeting certain criteria allowing the initiation of GLP toxicology studies by CytomX.
CX-188 (PD-1 Probody Therapeutic) Preclinical Program
- CytomX is advancing CX-188, a PD-1-directed Probody therapeutic, through IND application-enabling studies and expects to file an IND application in the second half of 2018.
- During the quarter,
Amgenand CytomX entered into a strategic collaboration in immuno-oncology in the field of Probody T-cell engaging bispecific antibodies including the co-development of a CytomX Probody T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target expressed on multiple human cancer types.
- Under the terms of the agreement,
Amgenand CytomX will co-develop a Probody T-cell engaging bispecific against EGFR-CD3 with CytomX leading early development. Amgenwill lead later development and commercialization with global late-stage development costs shared between the two companies. Amgenmade an upfront payment of $40 millionand purchased $20 millionof CytomX common stock.
- CytomX is eligible to receive up to
$455 millionin development, regulatory and commercial milestones for the EGFR program. Amgenwill lead global commercial activities with CytomX able to opt into a profit share in the U.S. and receive tiered, double-digit royalties on net product sales outside of the U.S. Amgenalso received exclusive worldwide rights to develop and commercialize up to three undisclosed targets. Should Amgenultimately pursue all of these targets, CytomX will be eligible to receive up to $950 millionin additional upfront and milestone payments and high single-digit to mid-double digit royalty payments on any resulting products.
- CytomX also received the rights from
Amgento an undisclosed preclinical T-cell engaging bispecific program; Amgenis eligible to receive milestones and royalty payments on any resulting products from this CytomX program.
- BMS continues to advance its CTLA-4-directed Probody therapeutic, which is expected to enter the clinic in early 2018.
- In addition, CytomX and
Bristol-Myers Squibbare evaluating a Probody version of Bristol-Myers Squibb'sCTLA-4 nonfucosylated (CLTA-4-NF) version of ipilimumab as part of the current collaboration.
Third Quarter Financial Results
Cash, cash equivalents and investments totaled
Research and development expenses were
General and administrative expenses were
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 efficacy of CytomX's 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 and CX-2009 and the timing of any future clinical trials to be initiated by CytomX or any of its collaborative partners. Two of our product candidates under our Probody platform are in the initial stages of clinical development and our 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. Projected net cash utilization and capital resources are subject to substantial risk of variance based on a wide variety of factors that can be difficult to predict. 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
|CYTOMX THERAPEUTICS, INC.|
|CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(in thousands, except share and per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Revenues from related party||482||625||1,429||1,620|
|Research and development||28,920||13,337||71,573||39,407|
|General and administrative||6,249||5,033||17,989||14,720|
|Total operating expenses||35,169||18,370||89,562||54,127|
|Loss from operations||(11,025||)||(14,916||)||(45,012||)||(45,356||)|
|Interest income, net||806||210||1,400||542|
|Other income (expense), net||(47||)||45||(101||)||(46||)|
|Loss before provision for income taxes||(10,266||)||(14,661||)||(43,713||)||(44,860||)|
|Provision (benefit) for income taxes||(19||)||1||7||7|
|Net loss per share, basic and diluted||$||(0.28||)||$||(0.40||)||$||(1.19||)||$||(1.24||)|
|Shares used to compute net loss per share, basic and diluted||36,947,129||36,324,805||36,757,119||36,168,026|
|CYTOMX THERAPEUTICS, INC.|
|CONDENSED BALANCE SHEETS|
|(in thousands, except share and per share data)|
|September 30,||December 31,|
|Cash and cash equivalents||$||284,225||$||104,645|
|Related party accounts receivable||68||154|
|Prepaid expenses and other current assets||4,848||3,896|
|Total current assets||376,374||188,147|
|Property and equipment, net||4,087||4,392|
|Liabilities and Stockholders' Equity|
|Deferred revenues, current portion||56,928||20,347|
|Total current liabilities||71,241||35,767|
|Deferred revenue, net of current portion||267,996||83,803|
|Deferred tax liability||520||513|
|Other long-term liabilities||1,803||566|
|Preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued and outstanding at September 30, 2017 and December 31, 2016.||-||-|
|Common stock, $0.00001 par value; 75,000,000 shares authorized; 37,095,462 and 36,490,169 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively||1||1|
|Additional paid-in capital||265,625||254,871|
|Accumulated other comprehensive loss||(61||)||(27||)|
|Total stockholders' equity||45,479||78,479|
|Total liabilities and stockholders' equity||$||387,039||$||199,128|
(1) The condensed consolidated balance sheet as of