Celldex Reports Fourth Quarter and Year-End 2014 Results
"2014 was another important year for Celldex, most notably for our lead product candidate, rindopepimut, which was recently issued the trade name Rintega®," said
"In addition to the significant progress made with Rintega, we advanced a number of key programs across our pipeline. The
Rintega® ("rindopepimut"; "rindo"; CDX-110) in EGFRvIII(v3)-Positive Glioblastoma (GBM):
February 2015, the U.S. Food and Drug Administration(FDA) granted Rintega Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma.
December 2014, enrollment was completed (n=745) in ACT IV, the Phase 3 registration study in newly diagnosed patients with GBM. ACT IV is the most comprehensive study conducted by a biotech company to date in this orphan disease and by far the largest study ever conducted in the EGFRvIII patient population. Interim analyses will be conducted by an independent Data Safety and Monitoring Board at 50 and 75% of events. The first interim analysis is expected in mid-2015.
November 2014, positive interim data from the Phase 2 ReACT study in patients with recurrent GBM were presented in a platform presentation at the 19th Annual Meeting of the Society for Neuro-Oncology(SNO). Rintega plus bevacizumab was very well tolerated. In bevacizumab-naïve patients treated with both Rintega and bevacizumab, a statistically significant overall survival (OS) benefit was reported (p=0.0208) with a hazard ratio of 0.47 (0.25, 0.91) in favor of the Rintega treated patients with early and consistent separation of the curves (median difference of 12.0 versus 8.8 months). Progression-free survival at six months (PFS-6) by investigator read was also positive with 27% of patients treated with Rintega still progression-free compared to 11% of control patients (p=0.048). Both OS and PFS-6 data continue to mature. Final data is anticipated by mid-year and the Company intends to present this data at a peer-reviewed medical meeting in this same time frame.
October 2014, the United States Patent and Trademark Office issued a registration mark for Rintega, the trade name for rindopepimut. Rintega is also a registered trademark in Canada, the European Unionand Japan.
Glembatumumab vedotin ("glemba"; CDX-011) targeting gpNMB in multiple cancers:
Patient enrollment is accelerating in the Company's Phase 2b randomized study (METRIC) of glemba in patients with metastatic triple negative breast cancers that overexpress gpNMB, a molecule associated with poor outcomes for triple negative breast cancer patients and the target of glemba. To date, 95 sites are open to enrollment across
the United States, Canada and Australia. In November 2014, the Company announced that the protocol was amended to align with current clinical practice, to pursue approval in Europeand to improve enrollment. The FDAand central European regulatory authorities have since reviewed the revised protocol design and the Company continues to believe the METRIC study could support marketing approval in both the US and Europedependent upon data review. Trial expansion into the European Unionwill be initiated this year. Based on current projections, enrollment will extend into 2016.
December 2014, a Phase 2 study of glemba in metastatic melanoma was initiated and is open to enrollment.
Celldex continues to advance plans to expand the study of glembatumumab vedotin into other cancers in which gpNMB is expressed.
- Assay optimization and validation for a Phase 2 study in squamous cell lung cancer was completed in late 2014 and the study will commence in 2015.
Celldex and the
National Cancer Institutehave entered into a Cooperative Researchand Development Agreement (CRADA) under which NCI will sponsor two studies of glembatumumab vedotin—one in uveal melanoma and one in pediatric osteosarcoma.
Varlilumab ("varli"; CDX-1127), an immune modulating mAb targeting CD27 in solid tumors and hematologic malignancies:
November 2014, the Company presented data from the completed solid tumor and B cell malignancy dose escalation cohorts and the solid tumor expansion cohorts at the Society for the Immunotherapy of Cancer(SITC) Annual Meeting. The study continues to maintain a very favorable safety profile and proof of concept has been observed with strong biological activity and clinical benefit in selected patients including:
- An ongoing complete response in a patient with Hodgkin lymphoma (18.9+ months)
- An ongoing partial response in a patient with renal cell carcinoma (11.0+ months) that has continued to decrease in tumor volume over time
13 patients with stable disease (3 - 30.7+ months)
May 2014, Celldex announced that it had entered into a clinical trial collaboration with Bristol-Myers Squibb Company (BMS) to evaluate the safety, tolerability and preliminary efficacy of Opdivo and varlilumab in a Phase 1/2 study in adult patients with advanced non-small cell lung cancer, metastatic melanoma, colorectal cancer, ovarian cancer, and head and neck squamous cell carcinoma. This study, which is being conducted by Celldex, is open to enrollment.
May 2014, Celldex announced that it had entered into a clinical trial collaboration with Oncothyreon Inc. to evaluate the safety, tolerability and preliminary efficacy of varlilumab and ONT-10, Oncothyreon's therapeutic vaccine targeting the tumor-associated antigen MUC1, in a Phase 1b study in patients with advanced breast or ovarian cancer. This study, which is being conducted by Oncothyreon, is open to enrollment.
Multiple efforts are underway for additional Phase 2 studies of varlilumab and the Company will provide updates on these studies as they are initiated, including but not limited to:
- A Phase 1/2 study of varlilumab and ipilimumab in patients with metastatic melanoma; plus CDX-1401 in NY-ESO-1 positive patients
- A Phase 1/2 study of varlilumab plus sunitinib in renal cell carcinoma
- A Phase 1/2 study of varlilumab plus a mek pathway agent (followed sequentially by a checkpoint inhibitor) for patients with B-raf mutated metastatic melanoma
CDX-1401, an antibody-based dendritic cell targeted vaccine aimed at tumors expressing the NY-ESO-1 oncoprotein:
April 2014, Celldex published Phase 1 results in Science Translational Medicine.
- CDX-1401 was well tolerated, demonstrated potent immune responses and 29% stable disease (median, 6.7 months).
Data suggest that CDX-1401 may predispose patients to better response to checkpoint blockade; 6 of 8 patients that received checkpoint inhibitors as next therapy had significant clinical responses.
Celldex continues to support several external collaborations, including:
National Cancer Institutesponsored Phase 2 study of CDX-1401 and CDX-301 for patients with metastatic melanoma, which is open to enrollment
- Additional studies of CDX-1401 combined with immune modulators are planned to initiate in 2015, including in combination with varlilumab and ipilimumab in NY-ESO-1 positive melanoma.
CDX-301 (Flt3L), a potent hematopoietic cytokine that stimulates the expansion and differentiation of hematopoietic stem cells and dendritic cells:
- A pilot study of CDX-301 alone and in combination with Mozobil® in hematopoietic stem cell transplantation was initiated in September of 2014 and is open to enrollment.
Fourth Quarter and Twelve Months 2014 Financial Highlights and 2015 Guidance
Cash position: Cash, cash equivalents and marketable securities as of
Revenues: Total revenue was
R&D Expenses: Research and development (R&D) expenses were
G&A Expenses: General and administrative (G&A) expenses were
Net loss: Net loss was
Financial guidance: Celldex expects that its cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through 2016, however, this could be impacted by our clinical data results from the Rintega program and their potential impact on our pace of commercial manufacturing and the rate of expansion of our commercial operations.
Rintega® is a registered trademark of
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Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline is built from a proprietary portfolio of antibodies and immunomodulators used alone and in strategic combinations to create novel, disease-specific therapies that induce, enhance or suppress the body's immune response. Visit www.celldex.com.
Forward Looking Statement
This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the Company's strategic focus and the future development and commercialization (by Celldex and others) of Rintega® ("rindopepimut"; "rindo"; CDX-110), glembatumumab vedotin ("glemba"; CDX-011), varlilumab ("varli"; CDX-1127), CDX-1401, CDX-301 and other products and our goals for 2014. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Rintega, glembatumumab vedotin and other drug candidates; our ability to obtain additional capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical and commercial grade materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to maintain and derive benefit from the Breakthrough Therapy Designation for rindopepimut, which does not change the standards for regulatory approval or guarantee regulatory approval on an expedited basis, or at all; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
|CELLDEX THERAPEUTICS, INC.|
|(In thousands, except per share amounts)|
|CONSOLIDATED STATEMENTS||Quarter Ended||Year Ended|
|OF OPERATIONS DATA||
|Product Development and Licensing Agreements||$ 320||$ 43||$ 838||$ 160|
|Contracts and Grants||1,157||577||2,748||1,617|
|Research and Development||27,026||17,804||104,381||67,401|
|General and Administrative||6,249||4,677||20,622||14,805|
|Amortization of Acquired Intangible Assets||253||253||1,013||1,013|
|Total Operating Expense||33,528||22,734||126,016||85,553|
|Investment and Other Income, Net||230||137||4,350||819|
|Net Loss||$ (31,821)||$ (22,062)||$ (118,080)||$ (81,550)|
|Basic and Diluted Net Loss per Common Share||$ (0.36)||$ (0.27)||$ (1.32)||$ (1.02)|
|Weighted Average Common Shares Outstanding||89,559||83,042||89,399||79,777|
|Cash, Cash Equivalents and Marketable Securities||$ 201,043||$ 302,983|
|Other Current Assets||3,942||2,206|
|Property and Equipment, net||10,535||9,973|
|Intangible and Other Assets, net||32,494||31,933|
|Total Assets||$ 248,014||$ 347,095|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Current Liabilities||$ 24,491||$ 20,350|
|Total Liabilities and Stockholders' Equity||$ 248,014||$ 347,095|
CONTACT: Company Contact:
Sarah CavanaughVice President of Investor Relations & Corp Communications Celldex Therapeutics, Inc.(781) 433-3161 email@example.com Media Inquiries: Dan Budwick Pure Communications, Inc.(973) 271-6085 firstname.lastname@example.org
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