CytomX Therapeutics Announces Full-Year 2019 Financial Results and Provides Business Update
As of December 31, 2019, CytomX had cash, cash equivalents and short-term investments of $296.1 million.
“During 2019, CytomX made substantial progress in advancing our clinical stage pipeline of innovative Probody therapeutics from Phase 1 platform proof of concept into Phase 2 clinical studies. We took major steps forward with our proprietary programs and in our partnerships and set the stage for significant updates throughout 2020,” said
Business Highlights and Recent Developments
Initiation of Combination Phase 2 Study of CX-072, An Anti-PD-L1 Probody Therapeutic
- In the fourth quarter of 2019, CytomX initiated 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 Yervoy® (ipilimumab), in patients with relapsed or refractory melanoma. Stage 1 of this two-stage trial will enroll up to 40 patients with initial data anticipated in 2020. Additional information is available at ClinicalTrials.gov using the identifier NCT03993379.
Initiation of Phase 2 Study of CX-2009, An Anti-CD166 Probody Drug Conjugate
- In the fourth quarter of 2019, CytomX initiated the PROCLAIM CX-2009 Phase 2 expansion study of CX-2009 monotherapy (7 mg/kg, administered every three weeks) in up to 40 patients with hormone receptor (ER, PR) positive, HER2-negative breast cancer. Initial data from this trial is anticipated in 2021. Additional information on this trial is available at ClinicalTrials.gov using the identifier NCT03149549.
Initiation of Part 2a of Ongoing Study by Bristol-Myers Squibb of BMS-986249, An Anti-CTLA-4 Probody Therapeutic
- Initiation by Bristol-Myers Squibb of a Phase 2 randomized cohort expansion in its ongoing first-in-human Phase 1/2a trial of the anti-CTLA-4 Probody BMS-986249, a Probody version of the anti-CTLA-4 antibody Yervoy® (ipilimumab), in combination with Opdivo® (nivolumab) in patients with metastatic melanoma. The advancement of BMS-986249 into this study triggered a milestone payment of
$10 millionfrom BMS to CytomX. Additional information is available at ClinicalTrials.gov using the Identifier NCT03369223.
Ongoing Dose Escalation Phase 1 Study of CX-2029, An Anti-CD71 Probody Drug Conjugate, within
- Continued patient enrollment by CytomX in the dose escalation phase of PROCLAIM-CX-2029 Phase 1/2 study, partnered with AbbVie, evaluating CX-2029 as monotherapy in patients with solid tumors. Initial data from Phase 1 dose escalation arm is anticipated in 2020 with proof-of-concept data from the first cohort expansion studies in specific tumor types anticipated in 2021. Additional information is available at ClinicalTrials.gov using the Identifier NCT003543813.
Phase 1 Study Initiation by Bristol Myers Squibb of BMS-986288, An Anti-CTLA-4 Probody Therapeutic
September 2019, Bristol-Myers Squibb initiated the dose escalation phase of a Phase 1/2a clinical study of a second anti-CTLA-4 Probody, BMS-986288, based on a modified version of Yervoy®, administered as monotherapy and in combination with Opdivo® in patients with selected advanced solid tumors. Additional information is available at ClinicalTrials.gov using the Identifier (NCT03994601).
December 2019, CytomX obtained exclusive worldwide development and commercial rights to ImmunoGen’s preclinical epithelial cell adhesion molecule (EpCAM)-targeting program that was developed utilizing CytomX’s Probody technology and ImmunoGen’s drug conjugate technology.
Probody T-Cell Bispecific Program
- CytomX’s most advanced program in the T-Cell Bispecific (TCB) modality is an Epidermal Growth Factor Receptor-CD3 TCB which is partnered with Amgen. CytomX anticipates advancing a lead candidate for this program during 2020.
Clinical Development Team Appointments
October 2019, the Company announced the appointment of Amy C. Peterson, M.D., as executive vice president and chief development officer. In this new role, Dr. Petersonhas oversight of a multi-disciplinary team focused on advancing all aspects of CytomX’s clinical development and product registration activities.
February 2020, the Company announced the appointment of Alison Hannah, M.D., as senior vice president and chief medical officer. In this role, Dr. Hannahoversees CytomX’s clinical development activities.
Anticipated 2020 Milestones
- Data is anticipated from the expansion arms of the Phase 1/2 trial of CX-072 as monotherapy in multiple selected tumor types.
- Initial data is anticipated from Stage 1 of the Phase 2 study of CX-072 in combination with Yervoy®.
- Data is anticipated from the CX-2009 Phase 1 dose escalation and dose ranging studies.
- Initial data is anticipated by CytomX and its partner, AbbVie, from the Phase 1 dose escalation stage of the PROCLAIM CX-2029 Phase 1/2 study.
Full Year 2019 Financial Results
Cash, cash equivalents and short-term investments totaled
Research and development expenses increased by
General and administrative expenses increased by
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CytomX is a clinical-stage, oncology-focused biopharmaceutical company with a vision of transforming lives with safer, more effective therapies. We are developing a novel class of investigational antibody therapeutics, based on our Probody® technology platform, for the treatment of cancer. As leaders in the field, our innovative technology is designed to turn previously undruggable targets into druggable targets and to enable more effective combination therapies. CytomX and its partners, comprised of leading biotechnology and pharmaceutical companies, have developed a robust pipeline of potential best-in-class immunotherapies against clinically validated targets and potential first-in-class therapeutics against novel, difficult to drug targets. Five novel drug-candidates utilizing our Probody technology are in the clinic, with three in Phase 2 studies and two in Phase 1 studies. These clinical programs include cancer immunotherapies against validated targets such as a PD-L1-targeting Probody therapeutic wholly owned by CytomX (CX-072) and the CTLA-4-targeting Probody therapeutics partnered with Bristol-Myers Squibb (BMS-986249 and BMS-986288). The CytomX clinical stage pipeline also includes first-in-class Probody drug conjugates against previously undruggable targets, including a CD166-targeting Probody drug conjugate wholly owned by CytomX (CX-2009) and a CD71-targeting Probody drug conjugate partnered with AbbVie (CX-2029). CD166 and CD71 are among cancer targets that are considered to be inaccessible to conventional antibody drug conjugates due to their presence on many healthy tissues. In addition to its wholly owned programs, CytomX has strategic collaborations with AbbVie, Amgen and BMS. For additional information 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. In particular, clinical progress is based on preliminary data from ongoing clinical trials and anticipated future disclosures of data are based on assumptions of clinical trial enrollment in our clinical trials and the clinical trials of our collaborative partners. 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; five 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; the possibility that current pre-clinical research may not result in additional product candidates; 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 Bristol-Myers Squibb.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
|Research and development||131,619||103,866||92,277|
|General and administrative||36,765||33,510||25,605|
|Total operating expenses||168,384||137,376||117,882|
|Loss from operations||(110,895||)||(77,874||)||(46,259||)|
|Other expense, net||(135||)||(68||)||(27||)|
|Loss before income taxes||(102,665||)||(70,301||)||(43,612||)|
|Provision for (benefit from) income taxes||(427||)||14,303||(513||)|
|Net loss per share, basic and diluted||$||(2.26||)||$||(2.03||)||$||(1.16||)|
|Shares used to compute net loss per share, basic and diluted||45,335,927||41,664,382||37,166,830|
|Other comprehensive income (loss):|
|Changes in unrealized gain (loss) on short-term investments, net of tax||139||1||(67||)|
|Impact of adoption of new accounting pronouncement||11||—||—|
|Total comprehensive loss||$||(102,088||)||$||(84,603||)||$||(43,166||)|
(in thousands, except share and per share data)
|Cash and cash equivalents||$||188,425||$||247,577|
|Prepaid expenses and other current assets||7,177||9,251|
|Total current assets||303,335||445,475|
|Property and equipment, net||7,372||6,934|
|Intangible assets, net||1,312||1,458|
|Operating lease right-of-use||25,382||—|
|Liabilities and Stockholders' Equity|
|Income tax payable||—||13,339|
|Deferred revenues, current portion||51,381||52,713|
|Total current liabilities||85,590||97,908|
|Deferred revenue, net of current portion||178,858||225,267|
|Operating lease liabilities - long term||24,871||—|
|Other long-term liabilities||850||3,050|
|Commitments and contingencies|
|Convertible preferred stock,
and outstanding at
|Additional paid-in capital||468,285||445,956|
|Accumulated other comprehensive income (loss)||57||(93||)|
|Total stockholders' equity||51,113||130,883|
|Total liabilities and stockholders' equity||$||341,282||$||457,108|
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Source: CytomX Therapeutics Inc.