CytomX Therapeutics Announces Second Quarter 2019 Financial Results and Provides Business Update
As of June 30, 2019, CytomX had cash, cash equivalents and short-term investments of $349.1 million.
“CytomX continues to make progress across its pipeline. Highlights of the second quarter included additional presentations of clinical data for our lead, wholly owned assets, CX-072 and CX-2009, which further demonstrated the potential of these two novel anti-cancer agents,” said
Business Highlights and Recent Developments
PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program
- CX-072 is a wholly owned Probody therapeutic targeting PD-L1, a clinically and commercially validated anti-cancer target.
- CytomX presented updated clinical data from monotherapy expansion cohorts (Part D) of the PROCLAIM-CX-072 Phase 1/2 study, evaluating the safety and efficacy of CX-072 in multiple tumor types at 10 mg/kg at the 2019 Annual
Society of Clinical Oncology( ASCO) Annual Meeting. These data demonstrated a favorable safety profile and evidence of anti-cancer activity in certain patients with triple negative breast cancer, anal squamous cell carcinoma, cutaneous squamous cell carcinoma and undifferentiated pleomorphic sarcoma. David Page, M.D., Medical Oncologist, Providence Cancer Centerpresented clinical data from PROCLAIM-CX-072 monotherapy and in combination with ipilimumab (YERVOY®) as part of a Poster Discussion Session at the 2019 ASCO Annual Meeting.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program
- CX-2009 is a wholly owned, first in class Probody drug conjugate (PDC) targeting CD166, a novel antigen that is broadly and highly expressed in many types of cancer.
- CytomX reported preliminary data from the dose-escalation phase (Part A and A2) of the ongoing PROCLAIM-CX-2009 Phase 1/2 study, evaluating the safety and antitumor activity of CX-2009 in seven selected tumor types, at the 2019
American Association for Cancer Research(AACR) Annual Meeting. CX-2009 was generally well tolerated. Single agent anti-cancer activity was observed in certain patients with breast cancer, ovarian cancer and head and neck cancer.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program
- CX-2029 is a first in class PDC targeting CD71, the Transferrin Receptor, a highly efficient cellular mechanism for the internalization of antibody drug conjugates in preclinical models.
- CD71 is widely expressed on normal tissues and therefore is considered to be an undruggable clinical target for conventional antibody drug conjugate technology.
- CytomX discovered and is developing CX-2029 in collaboration with
AbbVieto potentially turn CD71 into a druggable target.
- CytomX continues to enroll patients in the PROCLAIM-CX-2029 Phase 1/2 study 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 dose escalation clinical study evaluating BMS-986249 alone and in combination with OPDIVO® (nivolumab) in solid tumors that are advanced and have spread.
- BMS is preparing to initiate the Phase 2 portion of this clinical trial, upon which CytomX is entitled to a
$10 millionmilestone payment.
AbbVie Second Target Selection Under Strategic Oncology Collaboration
July 2019, CytomX announced its partner AbbVieselected a second target under the companies’ 2016 Discovery Collaboration and Licensing Agreement to discover and develop Probody drug conjugates. The target selection triggered a $10 millionpayment to CytomX.
Second Quarter 2019 Financial Results
Cash, cash equivalents and short-term investments totaled
Research and development expenses increased
General and administrative expenses increased by
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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, 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
YERVOY and OPDIVO are registered trademarks of
PROBODY is a trademark of
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Research and development||30,835||25,553||67,211||48,011|
|General and administrative||9,411||9,042||19,085||16,398|
|Total operating expenses||40,246||34,595||86,296||64,409|
|Loss from operations||(31,233||)||(13,257||)||(47,798||)||(28,887||)|
|Other income (expense), net||(88||)||61||(149||)||(79||)|
|Loss before income taxes||(28,960||)||(11,656||)||(43,091||)||(26,051||)|
|Provision for (benefit from) income taxes||—||1,791||(6||)||2,889|
|Net loss per share, basic and diluted||$||(0.64||)||$||(0.35||)||$||(0.95||)||$||(0.75||)|
|Shares used to compute net loss per share, basic and diluted||45,340,023||38,961,021||45,231,239||38,805,317|
|Other comprehensive income (loss):|
|Changes in unrealized gain (loss) on short-term investments, net of tax||136||50||291||(84||)|
|Impact of adoption of new accounting pronouncement||—||—||11||—|
CONDENSED BALANCE SHEETS
(in thousands, except share and per share data)
|June 30,||December 31,|
|Cash and cash equivalents||$||149,392||$||247,577|
|Prepaid expenses and other current assets||7,531||9,251|
|Total current assets||366,677||445,475|
|Property and equipment, net||7,238||6,934|
|Intangible assets, net||1,385||1,458|
|Operating lease right-of-use||26,743||—|
|Liabilities and Stockholders' Equity|
|Income tax payable||-||13,339|
|Deferred revenue, current portion||51,684||52,713|
|Total current liabilities||78,673||97,908|
|Deferred revenue, net of current portion||197,826||225,267|
|Operating lease liabilities - long term||26,321||—|
|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 June 30, 2019 and December 31, 2018.
|Common stock, $0.00001 par value; 75,000,000 shares authorized; 45,403,838 and
45,083,209 shares issued and outstanding at June 30, 2019 and December 31, 2018,
|Additional paid-in capital||459,367||445,956|
|Accumulated other comprehensive income (loss)||209||(93||)|
|Total stockholders' equity||101,501||130,883|
|Total liabilities and stockholders' equity||$||405,284||$||457,108|
(1) The condensed balance sheet as of
VP, Investor Relations and Corporate Communications
Source: CytomX Therapeutics Inc.