Celldex Reports Third Quarter 2012 Financial Results
Third Quarter and Recent Highlights
Celldex continued to advance the CDX-011 program, including requesting
and preparing for an end-of-Phase 2 meeting with the
Food and Drug Administrationto discuss future clinical and regulatory development for this program. In May of 2012, Celldex presented positive, topline results from the Phase 2b EMERGE study of CDX-011 in patients with advanced, refractory breast cancer. Preliminary results suggested that CDX-011 induced impressive response rates compared to currently available therapies in patient subsets with advanced, refractory breast cancers with high GPNMB expression (expression in ≥25% of tumor cells) and in patients with triple negative breast cancer. Mature data from the EMERGE study will be presented at the San Antonio Breast Cancer Symposium in December.
- Celldex continued its major initiative to open clinical sites to support enrollment in the Phase 3 ACT IV study and the Phase 2 ReACT study of rindopepimut in glioblastoma. In total, there are now more than 150 clinical sites around the world that have been selected to participate in the ACT IV study and, to date, 105 of these sites are actively screening patients. The ReACT study is also well positioned, with 25 study sites selected to participate and 21 actively screening to date.
Celldex presented positive results from its Phase 1 study of CDX-1401
in solid tumors at the
Society for Immunotherapy of Cancer(SITC) Annual Meeting on October 26, 2012. The study evaluated the safety, immunogenicity and clinical activity of escalating doses of CDX-1401 plus resiquimod and/or Poly ICLC (HiltonolTM) in 45 patients with advanced malignancies that had progressed after any available curative and/or salvage therapies. 60% of patients had confirmed NY-ESO-1 expression in archived tumor sample. Thirteen patients maintained stable disease for up to 13.4 months with a median of 6.7 months. Treatment was well-tolerated and there were no dose limiting toxicities. Humoral responses were elicited in both NY-ESO-1 positive and negative patients. NY-ESO-1-specific T cell responses were absent or low at baseline, but increased post-vaccination in 53% of evaluable patients, including both CD4 and/or CD8 T cell responses. Robust immune responses were observed with CDX-1401 with resiquimod and Poly ICLC alone and in combination. The study has identified a well-tolerated and immunogenic regimen and we expect that a study sponsored by the Cancer Immunotherapy Trials Network will be initiated in 2013.
Celldex received a new
Small Business Innovation Research(SBIR) contract award totaling approximately $200,000from the National Cancer Instituteto develop the combination of two immune modulators, CDX-301 (Flt3L) and CDX-1127 (an antibody that activates CD27) for use during radiotherapy.
Celldex recently completed patient accrual and treatment in the
CDX-301 healthy volunteer study and expects to present preliminary
results from this Phase 1 study at the
American Society of Hematology(ASH) Annual Meeting in December 2012.
Celldex expects to:
Present updated overall survival data from the rindopepimut Phase 2
ACT III, ACT II and ACTIVATE studies at the
Society for Neuro-Oncology(SNO) meeting in November 2012.
Present more mature data from the EMERGE Phase 2b study at the San
Antonio Breast Cancer Symposium in
- Complete Phase 1 accrual of the solid tumor arm of the CDX-1127 study in the fourth quarter of 2012.
- Initiate a Phase 2 pilot study of CDX-1135 in dense deposit disease (DDD), an orphan kidney disease in children and young adults, by year-end 2012. DDD is caused by uncontrolled activation of the alternative pathway of complement, which leads to progressive kidney damage and failure. CDX-1135 has been shown to inhibit the complement cascade at both the C3 and C5 levels and has shown clear biologic activity in DDD animal models and in earlier human clinical trials.
Participate in four upcoming financial conferences, the
Brean Capital2012 Life Sciences Summit and the Lazard Capital Markets9th Annual Healthcare Conference in November and the 2012 dbAccess BioFEST Conferenceand the Oppenheimer Annual Healthcare Conference in December.
Third Quarter Results
The net loss of
Revenues for the third quarter of 2012 increased when compared to
revenues in 2011, primarily because of Rotarix® related
product royalty revenues and contracts and grants revenue received
related to an APC-based HIV vaccine being funded through an SBIR grant
in collaboration with
R&D expenses in the third quarter of 2012 and 2011 were
G&A expenses in the third quarters of 2012 and 2011 were
Nine Month Results
The net loss of
Revenues for the first nine months of 2012 and 2011 were
R&D expense for the first nine months of 2012 was
G&A expense was
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: 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 rindopepimut (CDX-110), CDX-011, CDX-1135, CDX-1401, CDX-1127, CDX-301, Belinostat and other products. 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 limited cash reserves and our ability to obtain additional capital 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; our ability to adapt APC Targeting TechnologyTM to develop new, safe and effective vaccines against oncology and infectious disease indications; our ability to successfully complete product research and further development of our programs; the uncertainties inherent in clinical testing; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage research and development efforts for multiple products at varying stages of development; the timing, cost and uncertainty of obtaining regulatory approvals; 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.
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.
|(In thousands, except per share amounts)|
|CONSOLIDATED STATEMENTS||Quarter||Nine Months|
|OF OPERATIONS DATA||
||Ended September 30,|
|Product Development and|
|Contracts and Grants||79||5||228||5|
|Research and Development||11,769||8,594||33,650||22,615|
|General and Administrative||2,835||2,273||7,372||6,849|
|Amortization of Acquired Intangible Assets||254||656||836||1,622|
|Total Operating Expense||17,864||13,841||49,082||37,847|
|Investment and Other Income, Net||105||144||436||307|
Basic and Diluted Net Loss per
Weighted Average Common
|Other Current Assets||1,195||1,372|
|Property and Equipment, net||7,566||9,093|
|Intangible and Other Assets, net||33,461||34,217|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total Liabilities and Stockholders' Equity||$||119,837||$||97,994|
Vice President of IR & Corp Comm
Chief Financial Officer
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