CytomX Therapeutics Announces Third Quarter 2019 Financial Results and Provides Business Update
As of September 30, 2019, CytomX had cash, cash equivalents and short-term investments of $325.7 million.
“The CytomX clinical pipeline made excellent progress in Q3 as we continued to advance multiple Probody therapeutic programs across the portfolio,” said
Business Highlights and Recent Developments
CX-072 Anti-PD-L1 Probody Therapeutic Clinical Program
- In October, CytomX announced the initiation of the PROCLAIM (Probody Clinical Assessment In Man) CX-072-002 Phase 2 study evaluating the efficacy and tolerability of the anti-PD-L1 Probody CX-072, in combination with the anti-CTLA-4 antibody, ipilimumab, in patients with relapsed or refractory melanoma. The study utilizes a Simon Two-Stage design with approximately 40 patients being enrolled into Stage 1. CytomX anticipates initial data from Stage 1 in 2020. Additional information on this trial is available at ClinicalTrials.gov using the identifier NCT03993379.
- The Company also announced in October updated clinical data from the Phase 1 PROCLAIM-CX-072-001 dose-finding study of CX-072 in combination with ipilimumab. With enrollment complete, 27 evaluable patients had received ipilimumab (3, 6 or 10 mg/kg) combined with CX-072 (0.3, 1, 3 or 10 mg/kg), with the study achieving a disease control rate (stable disease or better) of 37%. 5 patients achieved confirmed objective responses by RECIST v1.1, including one complete response, for an overall response rate (ORR) of 19% in this heavily pretreated patient population. The median duration of response was 14.6 months (1.9 - 21.2 months) with 4 of the 5 responders still on treatment as of the latest data snapshot. Of the 27 patients treated across all doses, Grade 3/4 treatment related adverse events (TRAEs) were reported in 9 (33%) patients. Grade 3/4 immune-related adverse events (irAEs) were reported in 3 (15%) patients.
- Enrollment within the monotherapy cohorts of the PROCLAIM-CX-072-001 study is complete with evaluation of the activity and tolerability of CX-072 monotherapy continuing with ongoing treatment in select cohorts. Additional information on this trial is available at ClinicalTrials.gov using the identifier NCT03013491.
CX-2009 Anti-CD166 Probody Drug Conjugate Clinical Program
- CytomX anticipates announcing next steps for the PROCLAIM-CX-2009 clinical program by the end of 2019.
BMS-986249 Anti-CTLA-4 Probody Therapeutic Clinical Program
Bristol-Myers Squibb(BMS) is conducting a Phase 1/2a dose escalation clinical study evaluating BMS-986249 alone and in combination with OPDIVO® (nivolumab) in advanced solid tumors.
- BMS is preparing to initiate the Phase 2 portion of this clinical trial, upon which CytomX is entitled to a
$10 millionmilestone payment. Additional information on this trial is available at ClinicalTrials.gov using the Identifier NCT03369223.
CX-2029 Anti-CD71 Probody Drug Conjugate Clinical Program
- CytomX continued enrollment of patients in the PROCLAIM-CX-2029 Phase 1/2 study, which is partnered with
AbbVie, evaluating CX-2029 as monotherapy in patients with solid tumors or lymphomas. Additional information on this trial is available at ClinicalTrials.gov using the Identifier NCT003543813.
Additional Corporate Highlights
- In October, the Company announced the appointment of
Amy C. Peterson, M.D., as executive vice president and chief development officer. In this new role, Dr. Peterson will have oversight of a multi-disciplinary team focused on advancing all aspects of CytomX’s clinical development activities.
- In July, the Company announced that 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 from AbbVie.
Third 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 data referenced above for CX-072, including data on efficacy and safety, is of a specific date and 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, including the risk that enrollment in clinical trials may take longer than expected; 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
PROBODY is a registered trademark of
YERVOY and OPDIVO are registered trademarks of
ZELBORAF is a registered trademark of
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,|
|Research and development||27,967||27,549||95,178||75,560|
|General and administrative||8,463||8,137||27,548||24,535|
|Total operating expenses||36,430||35,686||122,726||100,095|
|Loss from operations||(25,718||)||(23,177||)||(73,516||)||(52,064||)|
|Other income (expense), net||22||29||(126||)||(50||)|
|Loss before income taxes||(23,699||)||(20,929||)||(66,788||)||(46,980||)|
|Provision for (benefit from) income taxes||—||2,502||(6||)||5,391|
|Net loss per share, basic and diluted||$||(0.52||)||$||(0.53||)||$||(1.47||)||$||(1.29||)|
|Shares used to compute net loss per share, basic and diluted||45,418,053||43,917,510||45,294,593||40,528,105|
|Other comprehensive income (loss):|
|Changes in unrealized gain (loss) on short-term investments, net of tax||(99||)||(30||)||192||(114||)|
|Impact of adoption of new accounting pronouncement||—||—||11||—|
CONDENSED BALANCE SHEETS
(in thousands, except share and per share data)
|September 30,||December 31,|
|Cash and cash equivalents||$||164,646||$||247,577|
|Prepaid expenses and other current assets||9,058||9,251|
|Total current assets||334,778||445,475|
|Property and equipment, net||7,107||6,934|
|Intangible assets, net||1,349||1,458|
|Operating lease right-of-use||26,069||—|
|Liabilities and Stockholders' Equity|
|Income tax payable||-||13,339|
|Deferred revenue, current portion||51,080||52,713|
|Total current liabilities||76,126||97,908|
|Deferred revenue, net of current portion||187,725||225,267|
|Operating lease liabilities - long term||25,621||—|
|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 September 30, 2019 and December 31, 2018.||—||—|
|Common stock, $0.00001 par value; 75,000,000 shares authorized; 45,426,468 and 45,083,209 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively||1||1|
|Additional paid-in capital||463,773||445,956|
|Accumulated other comprehensive income (loss)||110||(93||)|
|Total stockholders' equity||82,109||130,883|
|Total liabilities and stockholders' equity||$||372,544||$||457,108|
(1) The condensed balance sheet as of
VP, Investor Relations and Corporate Communications
Source: CytomX Therapeutics Inc.