HAMPTON, N.J., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business and financial highlights for the third quarter ended September 30, 2016.
"Celldex continues to demonstrate our commitment to combining therapeutic approaches to drive innovation in immuno-oncology for patients and their families," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "In the third quarter, we presented important data from our Phase 2 study of glembatumumab vedotin in checkpoint-refractory metastatic melanoma at ESMO, meeting the primary overall response endpoint and demonstrating clinically meaningful duration of response in this difficult-to-treat setting. Building on these promising signals, we are now enrolling a combination arm with our CD27 agonist, varlilumab, and are in the process of finalizing an additional arm to explore a glembatumumab vedotin and checkpoint inhibitor combination."
"Last week, we also announced the proposed acquisition of Kolltan Pharmaceuticals. This transaction would add a highly compatible platform of unique antibodies targeting receptor tyrosine kinases to our pipeline that we believe can be developed both independently and in combination with Celldex's existing product candidates. We are in the process of finalizing our integrated clinical development strategy and look forward to outlining these plans after closing the transaction. As multi-drug combination regimens become the standard in oncology, we fully recognize that the development programs to explore these opportunities become increasingly complex. We believe Celldex is well positioned to meet this challenge and will draw upon the leadership and expertise of Elizabeth Crowley, whom we promoted to the newly created role of Chief Product Development Officer in the third quarter," concluded Marucci.
Proposed Acquisition of Kolltan Pharmaceutics
Glembatumumab vedotin ("glemba"; CDX-011), an antibody-drug conjugate (ADC) 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 NY-ESO-1-antibody fusion protein for immunotherapy
CDX-301 (recombinant human Flt3L), a potent hematopoietic cytokine that uniquely expands the number of dendritic cells to prime the immune system for more robust immune responses to cancer antigens
CDX-014, an antibody-drug conjugate (ADC) targeting the transmembrane protein T-cell immunoglobulin mucin-1 (TIM-1) in renal cell carcinoma
RINTEGA® ("rindopepimut"; "rindo"; CDX-110), an EGFRvIII(v3)-specific therapeutic vaccine for glioblastoma (GBM)
CDX-1140, a fully human antibody targeted to CD40 that has demonstrated potent agonist activity.
Third Quarter and First Nine Months 2016 Financial Highlights and Updated 2016 Guidance
Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2016 were $203.2 million compared to $220.1 million as of June 30, 2016. The decrease was primarily driven by our third quarter cash used in operating activities of $24.0 million. At September 30, 2016, Celldex had 101.2 million shares outstanding.
Revenues: Total revenue was $2.2 million in the third quarter of 2016 and $4.9 million for the nine months ended September 30, 2016, compared to $1.0 million and $3.7 million for the comparable periods in 2015. Total revenue was primarily derived from 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 $25.0 million in the third quarter of 2016 and $78.2 million for the nine months ended September 30, 2016, compared to $24.7 million and $76.3 million for the comparable periods in 2015.
The increase in R&D expenses of $0.4 million between the three-month periods was primarily due to higher contract manufacturing of $1.7 million and personnel costs of $1.1 million, including higher stock-based compensation of $0.3 million, offset in part by lower clinical costs of $2.4 million.
The $1.9 million increase in R&D expenses between the nine-month periods was primarily due to higher contract manufacturing costs of $4.0 million and personnel costs of $4.9 million, including higher stock-based compensation of $1.6 million, offset by lower clinical costs of $8.1 million.
G&A Expenses: General and administrative (G&A) expenses were $7.0 million in the third quarter of 2016 and $24.0 million for the nine months ended September 30, 2016, compared to $8.5 million and $22.8 million for the comparable periods in 2015.
The decrease in G&A expenses of $1.5 million between the three-month periods was primarily due to lower commercial planning costs of $0.4 million and lower personnel costs of $0.6 million, including lower stock-based compensation of $0.4 million.
The $1.2 million increase in G&A expenses between the nine-month periods was primarily due to higher stock-based compensation of $1.4 million, offset by lower commercial planning costs of $0.3 million.
Net Loss: Net loss was $29.6 million, or ($0.29) per share, for the third quarter of 2016 and $96.2 million, or ($0.97) per share, for the nine months ended September 30, 2016, compared to a net loss of $32.0 million, or ($0.32) per share and $94.5 million, or ($0.98) per share for the comparable periods in 2015.
Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at September 30, 2016 combined with the anticipated proceeds from future sales of our common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations, including the proposed acquisition and integration of Kolltan Pharmaceuticals, through 2018; however, this could be impacted if we elected to pay Kolltan's shareholders contingent milestones in cash.
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. Tecentriq® is a registered trademark of Genentech. Hiltonol® is a registered trademark of Oncovir. Erbitux® is a registered trademark of Eli Lilly & Co.
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. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These 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 or that those goals will be achieved, 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, the ability of Kolltan and the Company to satisfy the closing conditions of the acquisition, including the risk that Kolltan's stockholders may not approve the merger; our ability to successfully integrate the business and programs of Kolltan with our business and programs; our ability to successfully complete research and further development and commercialization of glembatumumab vedotin and other Company and Kolltan 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 (or which Kolltan has initiated or plans 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 Fast Track designation for glembatumumab vedotin 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 and Kolltan'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)|
|STATEMENTS||Ended September 30,||Ended September 30,|
|OF OPERATIONS DATA||Consolidated||Consolidated|
|Product Development and|
|Contracts and Grants||1,727||649||3,362||2,636|
|Research and Development||25,009||24,656||78,168||76,271|
|General and Administrative||6,950||8,487||24,049||22,761|
|Amortization of Acquired Intangible Assets||254||254||760||760|
|Total Operating Expense||32,213||33,397||102,977||99,792|
|Investment and Other Income, Net||395||391||1,841||1,590|
|Basic and Diluted Net Loss per|
|Weighted Average Common|
|BALANCE SHEETS||September 30,||December 31,|
|Cash, Cash Equivalents and Marketable Securities||$||203,248||$||289,889|
|Other Current Assets||6,466||5,047|
|Property and Equipment, net||11,355||11,461|
|Intangible and Other Assets, net||30,878||31,187|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total Liabilities and Stockholders' Equity||$||251,947||$||337,584|
Company Contact Sarah Cavanaugh Vice President of Investor Relations & Corp Communications Celldex Therapeutics, Inc. (781) 433-3161 email@example.com Charles Liles Associate Director of Investor Relations & Corp Communications Celldex Therapeutics, Inc. (781) 433-3107 firstname.lastname@example.org Media Inquiries Dan Budwick BrewLife (973) 271-6085 email@example.com