CytomX Therapeutics Announces Third Quarter 2018 Financial Results
ESMO Presentations Support CX-072 Product Profile and Probody™ Proof-of-Concept
Advancement of Clinical Stage Probody Drug Conjugate Programs, CX-2009 and CX-2029
CX-188 IND Filing Marks Fifth Probody Therapeutic to Advance in Clinical Development
Company to Host a Conference Call Today at
As of September 30, 2018, CytomX had cash, cash equivalents and short-term investments of $464.6 million.
“During the third quarter, CytomX made broad progress across our highly innovative pipeline of Probody therapeutics,” said
Business Highlights and Recent Developments
PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program
- CX-072 is a potentially best in class Probody therapeutic targeting PD-L1, a clinically- and commercially-validated anti-cancer target.
- CytomX presented updated interim clinical data from two arms of the Phase 1/2 PROCLAIM-CX-072 program with a data cutoff of
August 3, 2018 at the 2018European Society of Medical Oncology (ESMO ) Annual Meeting.- CX-072 monotherapy was studied in PD-L1/PD-1 inhibitor naïve patients with advanced unresectable solid tumors or lymphomas for which no PD-L1 or PD-1 inhibitor was approved or available for their disease (Parts A and A2).
- The Maximum Tolerated Dose (MTD) was not reached.
- Of the 46 patients treated, Grade 3/4 treatment-related adverse events (TRAE) were reported in five patients (11%) and Grade 3/4 immune-related adverse events (irAEs) were observed in 3 patients (7%).
- Of the 18 patients treated at doses of 3 mg/kg or above, 3 (17%) achieved an objective response with 1 confirmed and ongoing partial response (PR) and 2 unconfirmed PRs observed. Stable disease was observed in 8 patients (44%) for an overall Disease Control Rate (DCR) of 61%.
- CX-072 in combination with Yervoy® (ipilimumab) was studied in patients with advanced unresectable solid tumors or lymphomas for which no PD-L1 or PD-1 inhibitor was approved or available for their disease (Part B).
- Of the 20 patients treated, Grade 3/4 TRAEs were reported in four patients (20%) and Grade 3/4 immune-related adverse events (irAEs) were reported in 2 patients (10%).
- Of the 14 patients treated with 3 mg/kg of ipilimumab and 0.3 – 10 mg/kg of CX-072, 3 (21%) achieved an objective response with 1 confirmed complete response (CR), and 2 confirmed PRs observed. Stable disease was observed in 21% of patients for an overall DCR of 43%.
- CX-072 monotherapy was studied in PD-L1/PD-1 inhibitor naïve patients with advanced unresectable solid tumors or lymphomas for which no PD-L1 or PD-1 inhibitor was approved or available for their disease (Parts A and A2).
- CytomX continues to enroll and dose patients in monotherapy expansion cohorts in 8 undisclosed tumor types at the dose of 10mg/kg (Part D). Initial clinical data from Part D is expected in 2019.
- CytomX continues to enroll and dose patients in a combination trial of CX-072 plus Zelboraf® (vemurafenib) in patients with V600E BRAF-positive melanoma (Part C).
- CytomX will be presenting clinical translational data from Part A2 of the CX-072 monotherapy trial later this week as a poster and in a rapid-fire oral presentation at the 33rd Annual Meeting of
The Society for Immunotherapy of Cancer (SITC ).- The Company will be hosting an Analyst and Investor event on
Saturday, November 10th atSITC that will be webcast. Webcast details can be found under the Investor and News section of the Company’s website at www.CytomX.com.
- The Company will be hosting an Analyst and Investor event on
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program
- CX-2009 is a first in class Probody drug conjugate (PDC) that targets CD166, a broadly and highly expressed tumor antigen.
- In the second quarter of 2017, CytomX initiated the PROCLAIM-CX-2009 Phase 1/2 clinical program to evaluate the safety and preliminary anti-tumor efficacy of CX-2009.
- Part A (monotherapy dose escalation) was initiated at a dose of 0.25 mg/kg with an anticipated top dose of 6 mg/kg. As of
November 2, 2018 , the enrolling dose level was 10 mg/kg. - Part A2, was initiated in the second quarter of 2018. In Part A2, patients with CD166+++ expressing tumors are enrolled to receive CX-2009 at doses of 4 mg/kg and above already cleared in Part A (6 patients per dosing cohort). Biopsies are mandatory in A2. As of
November 2, 2018 , patients were being enrolled in a 9 mg/kg dosing cohort.
- CytomX anticipates providing a comprehensive update on the CX-2009 program in the first half of 2019 following the substantial completion of Parts A and A2.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program
- CytomX, in collaboration with AbbVie, is advancing CX-2029, a CD71-directed PDC.
- CytomX initiated Part A of the PROCLAIM-CX-2029 Phase 1/2 clinical program in
July 2018 .
CX-188 (PD-1 Probody Therapeutic) Preclinical Program
- CytomX filed an Investigational New Drug (IND) application for CX-188 in October and expects to commence dose escalation studies following IND clearance from the
U.S. Food and Drug Administration .
Financial Highlights
- In July, CytomX completed an underwritten public offering of 5,867,347 common shares which resulted in net proceeds of
$134.6 million to CytomX.
Third Quarter 2018 Financial Results
Cash, cash equivalents and short-term investments totaled
Revenue was
Research and development expenses decreased by
General and administrative expenses increased by
Conference Call and Webcast Information
CytomX management will host a conference call today at
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 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
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(unaudited)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenue | $ | 12,509 | $ | 23,662 | $ | 48,031 | $ | 43,121 | ||||||||
| Revenue from related party | — | 482 | — | 1,429 | ||||||||||||
| Total revenue | 12,509 | 24,144 | 48,031 | 44,550 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 27,549 | 28,920 | 75,560 | 71,573 | ||||||||||||
| General and administrative | 8,137 | 6,249 | 24,535 | 17,989 | ||||||||||||
| Total operating expenses | 35,686 | 35,169 | 100,095 | 89,562 | ||||||||||||
| Loss from operations | (23,177 | ) | (11,025 | ) | (52,064 | ) | (45,012 | ) | ||||||||
| Interest income | 2,219 | 806 | 5,134 | 1,400 | ||||||||||||
| Other income (expense), net | 29 | (47 | ) | (50 | ) | (101 | ) | |||||||||
| Loss before provision for income taxes | (20,929 | ) | (10,266 | ) | (46,980 | ) | (43,713 | ) | ||||||||
| Provision for (benefit from) income taxes | 2,502 | (19 | ) | 5,391 | 7 | |||||||||||
| Net loss | $ | (23,431 | ) | $ | (10,247 | ) | $ | (52,371 | ) | $ | (43,720 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.53 | ) | $ | (0.28 | ) | $ | (1.29 | ) | $ | (1.19 | ) | ||||
| Shares used to compute net loss per share, basic and diluted | 43,917,510 | 36,947,129 | 40,528,105 | 36,757,119 | ||||||||||||
| Other comprehensive income (loss): | ||||||||||||||||
| Changes in unrealized gains (losses) on short-term investments | (30 | ) | 49 | (114 | ) | (34 | ) | |||||||||
| Comprehensive loss | $ | (23,461 | ) | $ | (10,198 | ) | $ | (52,485 | ) | $ | (43,754 | ) | ||||
CONDENSED BALANCE SHEETS
(in thousands, except share and per share data)
| September 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| (unaudited) | (1) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 259,753 | $ | 177,548 | ||||
| Short-term investments | 204,809 | 196,562 | ||||||
| Accounts receivable | 56 | 10,139 | ||||||
| Prepaid expenses and other current assets | 7,890 | 4,352 | ||||||
| Total current assets | 472,508 | 388,601 | ||||||
| Property and equipment, net | 5,482 | 4,218 | ||||||
| Intangible assets, net | 1,495 | 1,604 | ||||||
| Goodwill | 949 | 949 | ||||||
| Restricted cash | 917 | 917 | ||||||
| Other assets | 1,375 | 1,355 | ||||||
| Total assets | $ | 482,726 | $ | 397,644 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,871 | $ | 4,205 | ||||
| Income tax payable | 4,990 | 1 | ||||||
| Accrued liabilities | 21,416 | 16,382 | ||||||
| Deferred revenue, current portion | 52,997 | 40,559 | ||||||
| Total current liabilities | 86,274 | 61,147 | ||||||
| Deferred revenue, net of current portion | 236,365 | 264,704 | ||||||
| Other long-term liabilities | 2,426 | 1,897 | ||||||
| Total liabilities | 325,065 | 327,748 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Convertible preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued and outstanding at September 30, 2018 and December 31, 2017. | — | — | ||||||
| Common stock, $0.00001 par value; 75,000,000 shares authorized; 44,997,279 and 38,478,560 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively | 1 | 1 | ||||||
| Additional paid-in capital | 440,616 | 289,454 | ||||||
| Accumulated other comprehensive loss | (208 | ) | (94 | ) | ||||
| Accumulated deficit | (282,748 | ) | (219,465 | ) | ||||
| Total stockholders' equity | 157,661 | 69,896 | ||||||
| Total liabilities and stockholders' equity | $ | 482,726 | $ | 397,644 | ||||
__________________
(1) The condensed balance sheet as of
Investor and Media Contact
VP, Investor Relations and Corporate Communications
ckeenan@cytomx.com
650-383-0823
Source: CytomX Therapeutics Inc.