CytomX Therapeutics Announces Third Quarter 2016 Financial Results and Provides Pipeline Update
“This quarter was marked by a number of significant milestones in our Probody pipeline, most notably the filing of our Investigational New Drug (IND) application for CX-072, our PD-L1-targeting Probody therapeutic for the treatment of cancer patients,” said
As of
Business Highlights and Recent Developments
PROCLAIM-072 (PD-L1 Probody) Program
- IND application filed with the U.S.
FDA for PROCLAIM-072 clinical study of CX-072, a PD-L1-targeting Probody therapeutic for the treatment of cancer patients. - Pending ongoing discussions with the
FDA regarding clinical protocol finalization, initial clinical sites are expected to be open by year end to support first patient enrollment. - Clinical data is expected to begin to emerge in the second half of 2017, and throughout 2018.
CX-2009 (CD166 Probody Drug Conjugate) Program
- The IND for CX-2009, a first-in-class Probody drug conjugate targeting the highly expressed tumor antigen CD166, remains on track to be filed during the first half of 2017.
- Clinical data is expected to begin to emerge in the second half of 2017, and throughout 2018.
Other Pipeline Updates
- Pursuant to CytomX’s partnership with
AbbVie ,AbbVie exercised a licensing option withSeattle Genetics for the clinically and commercially validated payload, MMAE, for conjugation to the CD71 Probody Drug Conjugate that is being advanced in preclinical studies.
Upcoming Presentations
CytomX and partner
ESMO
- Title: Next Generation Anti-CTLA-4 Antibodies
Presenter:Alan J. Korman , Ph.D., vice president, immuno-oncology, Bristol-Myers Squibb Company
Date:Saturday, November 5, 2016
Time:8:00-8:20 a.m. CET
Session: Beyond PD-1/PD-L1 Axis Blockade: Combinations or New Molecules
- Title: CD3-EGFR Probody T Cell-Engaging Bispecific Induces Tumor Regressions and Substantially Increases Safety Window in Preclinical Studies
Presenter:Bryan A. Irving , Ph.D., vice president, immunology,CytomX Therapeutics
Date:Wednesday, November 9, 2016
Time:11:45-11:50 a.m. EST
Sub-Session II: Pre-Clinical New Agents in Development - Title: Probody Therapeutic Targeting PD-1 Provides Preclinical Anti-tumor Efficacy While Minimizing Induction of Autoimmunity as a Single Agent and in Combination with CTLA-4 Blockade
Presenter:Kimberly A. Tipton , senior scientist,CytomX Therapeutics
Date:Friday, November 11, 2016
Time:12:15-1:30 p.m. and6:15-7:30 p.m. EST
Session: Poster - Title: Next Generation Anti-CTLA-4 Antibodies
Presenter:Alan J. Korman , Ph.D., vice president, immuno-oncology, Bristol-Myers Squibb Company
Date:Saturday, November 12, 2016
Time:9:10-9:35 a.m. EST
Session: Beyond Single-Agents: The Future of Combination Immunotherapy
Third Quarter Financial Results
Cash, cash equivalents and investments totaled
Research and development expenses were
General and administrative expenses were
About PROCLAIM
CytomX is launching the PROCLAIM (Probody Clinical Assessment In Man), a first-of its-kind clinical trial program that enables clinical study sites and physicians to access CytomX’s wholly-owned Probody therapeutics under one international umbrella. The first module within the PROCLAIM program is an open-label, dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and in combination with Yervoy® (ipilimumab) or Zelboraf® (vemurafenib) in anti-PD-(L)1 inhibitor naïve patients with certain cancers. CX-072 is a PD-L1-targeting Probody therapeutic for the treatment of cancer patients. CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:
- Safety: Demonstrate that CX-072 is well tolerated in patients, and potentially improves safety, particularly in the combination setting.
- Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
- Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical studies.
Clinical data is expected to begin to emerge in the second half of 2017, and throughout 2018. The IND application for CX-072 is currently under review with
About
CytomX is an oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody technology platform. The Company uses the platform to create proprietary cancer immunotherapies against clinically-validated targets, as well as to develop first-in-class investigational cancer therapeutics against novel targets. CytomX believes that its Probody platform has the potential to improve the combined efficacy and safety profile of monoclonal antibody modalities, including cancer immunotherapies, antibody drug conjugates and T-cell-recruiting bispecific antibodies. Probody therapeutics are designed to take advantage of unique conditions in the tumor microenvironment to enhance the tumor-targeting features of an antibody and reduce drug activity in healthy tissues. The Company’s investigational Probody therapeutics address clinically-validated cancer targets in immuno-oncology, such as PD-L1, against which the clinical candidate CX-072 is directed, as well as novel targets, such as CD-166, that are difficult to drug without causing damage to healthy tissues. In addition to its proprietary programs, CytomX is collaborating with strategic partners including
Forward-Looking Statements
This press release includes forward-looking statements, including statements related to the development and advancement of the Company’s product candidates into, and the successful completion of, clinical trials, including with respect to the timing of a Phase 1 clinical trial for CX-072 and the timing of an IND submission and the Phase 1 clinical trial for CX-2009, the availability of data from such clinical trials, the timing and success of certain of the Company’s collaborations and the Company’s ability to identify potential collaborators. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond the Company’s 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. The Company’s Probody platform is in preclinical development, and the process by which a preclinical technology 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, the accuracy of the Company’s estimates relating to its ability to initiate and/or complete clinical trials, the Company’s ability to demonstrate evidence of efficacy and safety of its product candidates during clinical trials, the unpredictability of the regulatory process, regulatory developments in
| CYTOMX THERAPEUTICS, INC. CONDENSED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) |
||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues | $ | 2,829 | $ | 1,471 | $ | 7,151 | $ | 4,422 | ||||||||
| Revenues from related parties | 625 | 468 | 1,620 | 1,302 | ||||||||||||
| Total revenues | 3,454 | 1,939 | 8,771 | 5,724 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 13,337 | 9,157 | 39,407 | 18,854 | ||||||||||||
| General and administrative | 5,033 | 4,051 | 14,720 | 8,549 | ||||||||||||
| Total operating expenses | 18,370 | 13,208 | 54,127 | 27,403 | ||||||||||||
| Loss from operations | (14,916 | ) | (11,269 | ) | (45,356 | ) | (21,679 | ) | ||||||||
| Interest income | 692 | 407 | 1,842 | 874 | ||||||||||||
| Interest expense | (482 | ) | (718 | ) | (1,300 | ) | (1,356 | ) | ||||||||
| Other income (expense), net | 45 | (287 | ) | (46 | ) | (1,718 | ) | |||||||||
| Loss before provision for income taxes | (14,661 | ) | (11,867 | ) | (44,860 | ) | (23,879 | ) | ||||||||
| Provision for income taxes | 1 | 3 | 7 | 8 | ||||||||||||
| Net loss | (14,662 | ) | (11,870 | ) | (44,867 | ) | (23,887 | ) | ||||||||
| Accretion to redemption value and cumulative dividends on preferred stock | — | (2,958 | ) | — | (6,147 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (14,662 | ) | $ | (14,828 | ) | $ | (44,867 | ) | $ | (30,034 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.40 | ) | $ | (14.26 | ) | $ | (1.24 | ) | $ | (29.66 | ) | ||||
| Shares used to compute net loss per share attributable to common stockholders, basic and diluted | 36,324,805 | 1,039,567 | 36,168,026 | 1,012,534 | ||||||||||||
| CYTOMX THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands, except share and per share data) (unaudited) |
||||||||
| September 30, | December 31, | |||||||
| 2016 | 2015 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 59,758 | $ | 59,822 | ||||
| Short-term investments | 118,707 | 126,889 | ||||||
| Accounts receivable | 240 | 372 | ||||||
| Related party accounts receivable | 207 | 372 | ||||||
| Prepaid expenses and other current assets | 4,401 | 2,299 | ||||||
| Total current assets | 183,313 | 189,754 | ||||||
| Long-term investments | 2,025 | — | ||||||
| Property and equipment, net | 3,701 | 3,481 | ||||||
| Intangible assets | 1,750 | 1,750 | ||||||
| Goodwill | 949 | 949 | ||||||
| Restricted cash | 917 | 917 | ||||||
| Other assets | 226 | 364 | ||||||
| Total assets | $ | 192,881 | $ | 197,215 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 517 | $ | 4,697 | ||||
| Accrued liabilities | 9,041 | 4,912 | ||||||
| Deferred revenues, current portion | 14,124 | 6,130 | ||||||
| Total current liabilities | 23,682 | 15,739 | ||||||
| Deferred revenue, net of current portion | 79,110 | 54,703 | ||||||
| Deferred tax liability | 513 | 507 | ||||||
| Other long-term liabilities | 154 | 198 | ||||||
| Total liabilities | 103,459 | 71,147 | ||||||
| Commitments and contingencies | ||||||||
| Preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued and outstanding at September 30, 2016 and December 31, 2015. | — | — | ||||||
| Common stock, $0.00001 par value; 75,000,000 shares authorized; 36,392,821 and 36,033,209 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | 1 | 1 | ||||||
| Stockholders notes receivable | — | (78 | ) | |||||
| Additional paid-in capital | 251,748 | 243,687 | ||||||
| Accumulated other comprehensive income / (loss) | 6 | (76 | ) | |||||
| Accumulated deficit | (162,333 | ) | (117,466 | ) | ||||
| Total stockholders' equity | 89,422 | 126,068 | ||||||
| Total liabilities and stockholders' equity | $ | 192,881 | $ | 197,215 | ||||
Corporate Communications Contact:Canale Communications Ian Stone ian@canalecomm.com 619-849-5388 Investor Contact:Trout Group Pete Rahmer prahmer@troutgroup.com 646-378-2973