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HAMPTON, N.J., Aug. 10, 2015 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business and financial highlights for the second quarter ended June 30, 2015.
"Celldex is acutely aware of the significant unmet need for patients with glioblastoma, and we continue to focus considerable efforts on advancing the RINTEGA® program," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "At ASCO in June, we presented data from the Phase 2 ReACT study, which achieved the primary endpoint of progression-free survival at six months and, most importantly, demonstrated a survival benefit for patients on the RINTEGA arm. We continue to follow these patients and look forward to presenting data on the emerging long-term survival benefit later this year. The Phase 3 ACT IV study continues to progress as planned, and we look forward to the second interim analysis in late 2015/early 2016."
"Our momentum is further supported by ongoing progress in our pipeline. Varlilumab is now in four combination studies, and we anticipate that a fifth study with Roche's anti-PDL1 antibody will start later this year. We look forward to presenting data from a number of these studies in 2016 and believe these data will define an important role for varlilumab in cancer immunotherapy treatment. Glembatumumab vedotin also continues to actively enroll patients in two trials—the METRIC study in triple negative breast cancer and a study in metastatic melanoma. We are completing preparations that support the opening of METRIC study sites in the EU early next year and remain on track to complete enrollment in 2016. As we continue to advance Celldex towards becoming a fully integrated, commercial-stage biotechnology company, we were pleased to announce the promotion of Dr. Rick Wright to the position of Chief Commercial Officer. In this role, Rick will be responsible for developing a global business strategy and building the infrastructure required to support commercialization of RINTEGA and our cancer immunotherapy pipeline," concluded Marucci.
RINTEGA® ("rindopepimut"; "rindo"; CDX-110), an EGFRvIII(v3)-specific therapeutic vaccine for glioblastoma (GBM)
Glembatumumab vedotin ("glemba"; CDX-011), an antibody-drug conjugate targeting gpNMB in multiple cancers
Varlilumab ("varli"; CDX-1127), a fully human monoclonal agonist antibody that binds and activates CD27, a critical co-stimulatory molecule in the immune activation cascade
CDX-1401, an antibody-based NY-ESO-1-specific therapeutic vaccine for multiple solid tumors
CDX-301 (recombinant human Flt3L), a potent hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells
Second Quarter and First Six Months 2015 Financial Highlights and 2015 Guidance
Cash position: Cash, cash equivalents and marketable securities as of June 30, 2015 were $334.0 million compared to $359.8 million as of March 31, 2015. The decrease was primarily driven by our second quarter net cash burn of $25.8 million. As of June 30, 2015 Celldex had 98.5 million shares outstanding.
Revenues: Total revenue was $2.2 million in the second quarter of 2015 and $2.7 million for the six months ended June 30, 2015, compared to $0.6 million and $1.0 million for the comparable periods in 2014. The increase in the second quarter of 2015 and the six months ended June 30, 2015 was primarily due to our clinical trial collaboration with Bristol-Myers Squibb and our research and development agreement with Rockefeller University.
R&D Expenses: Research and development (R&D) expenses were $26.5 million in the second quarter of 2015 and $51.6 million for the six months ended June 30, 2015, compared to $24.1 million and $51.2 million for the comparable periods in 2014.
G&A Expenses: General and administrative (G&A) expenses were $8.2 million in the second quarter of 2015 and $14.3 million for the six months ended June 30, 2015, compared to $4.8 million and $9.4 million for the comparable periods in 2014. The increase in G&A expenses was primarily attributable to higher commercial personnel-related expenses as we prepare for potential product launch and a $2.2 million increase year to date in RINTEGA and glembatumumab vedotin commercial planning costs over the $1.9 million spent in the comparable period in 2014.
Net loss: Net loss was $32.4 million, or ($0.33) per share, for the second quarter of 2015 and $62.5 million, or ($0.65) per share, for the six months ended June 30, 2015, compared to a net loss of $28.3 million, or ($0.32) per share and $58.2 million, or ($0.65) per share for the comparable periods in 2014.
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 2017; 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 Celldex Therapeutics. Opdivo® and Yervoy® are registered trademarks of Bristol-Myers Squibb. Sutent® is a registered trademark of Pfizer. Mozobil® is a registered trademark of sanofi-aventis U.S. LLC.
Webcast and Conference Call
Celldex executives will host a conference call at 4:30 p.m. ET today to discuss financial and business results and to provide an update on key 2015 objectives. The conference call and presentation will be webcast live over the Internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 4299662.
A replay of the call will be available approximately two hours after the live call concludes through August 16, 2015. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 4299662. The webcast will also be archived on the Company's website.
About Celldex Therapeutics, Inc.
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 2015. 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 RINTEGA, 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||Six Months|
|OF OPERATIONS DATA||Ended June 30,||Ended June 30,|
|Product Development and Licensing Agreements||$ 334||$ 200||$ 676||$ 235|
|Contracts and Grants||1,844||392||1,988||773|
|Research and Development||26,490||24,100||51,615||51,169|
|General and Administrative||8,184||4,787||14,273||9,369|
|Amortization of Acquired Intangible Assets||254||254||507||507|
|Total Operating Expense||34,928||29,141||66,395||61,045|
|Investment and Other Income, Net||391||275||1,198||1,860|
|Net Loss||$ (32,359)||$ (28,274)||$ (62,533)||$ (58,177)|
|Basic and Diluted Net Loss per Common Share||$ (0.33)||$ (0.32)||$ (0.65)||$ (0.65)|
|Weighted Average Common Shares Outstanding||98,482||89,361||95,477||89,316|
|BALANCE SHEETS||June 30,||December 31,|
|Cash, Cash Equivalents and Marketable Securities||$ 333,992||$ 201,043|
|Other Current Assets||5,549||3,942|
|Property and Equipment, net||11,735||10,535|
|Intangible and Other Assets, net||31,941||32,494|
|Total Assets||$ 383,217||$ 248,014|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Current Liabilities||$ 26,691||$ 24,491|
|Total Liabilities and Stockholders' Equity||$ 383,217||$ 248,014|
CONTACT: Company Contact: Sarah Cavanaugh Vice 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.orgNEXT ARTICLE
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