HAMPTON, N.J., Aug. 08, 2016 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business and financial highlights for the second quarter ended June 30, 2016.
"Celldex continues to build one of the most robust pipelines in immuno-oncology, most recently advancing CDX-014 into the clinic in renal cell carcinoma," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "In collaboration with our investigators, we also presented a significant body of data in the second quarter with eight presentations across both AACR and ASCO that spoke to the broad utility of our product candidates in combination immunotherapy and highlighted a number of the novel targets we are pursuing."
"We continue to enroll patients to the pivotal METRIC study of glembatumumab vedotin in triple negative breast cancer, with a focus on a number of new sites in Europe that were added over the last quarter and look forward to presenting data from the Phase 2 study of glembatumumab vedotin in metastatic melanoma later this year," concluded Marucci.
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)
Second Quarter and First Six Months 2016 Financial Highlights and Updated 2016 Guidance
Cash position: Cash, cash equivalents and marketable securities as of June 30, 2016 were $220.1 million compared to $254.0 million as of March 31, 2016. The decrease was primarily driven by our second quarter cash used in operating activities of $33.8 million, $5.9 million of which were RINTEGA-related payments. At June 30, 2016, Celldex had 99.4 million shares outstanding.
Revenues: Total revenue was $1.4 million in the second quarter of 2016 and $2.7 million for the six months ended June 30, 2016, compared to $2.2 million and $2.7 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 $25.7 million in the second quarter of 2016 and $53.2 million for the six months ended June 30, 2016, compared to $26.5 million and $51.6 million for the comparable periods in 2015.
The decrease in R&D expenses of $0.8 million between the three-month periods was primarily due to lower clinical costs of $3.2 million, offset in part by increased contract manufacturing costs of $0.8 million and personnel costs of $1.6 million, including higher stock-based compensation of $0.8 million.
The increase in R&D expenses of $1.6 million between the six-month periods was primarily due to higher contract manufacturing and other contract service costs and personnel costs, including higher stock-based compensation of $1.3 million, offset by lower clinical costs.
G&A Expenses: General and administrative (G&A) expenses were $7.8 million in the second quarter of 2016 and $17.1 million for the six months ended June 30, 2016, compared to $8.2 million and $14.3 million for the comparable periods in 2015.
The decrease in G&A expenses of $0.4 million between the three-month periods was primarily due to lower commercial planning costs of $1.1 million, partially offset by higher stock-based compensation of $0.7 million.
The $2.8 million increase in G&A expenses between the six-month periods was primarily due to higher stock-based compensation of $1.8 million, facility costs and legal costs.
Net loss: Net loss was $32.0 million, or ($0.32) per share, for the second quarter of 2016 and $66.6 million, or ($0.67) per share, for the six months ended June 30, 2016, compared to a net loss of $32.4 million, or ($0.33) per share and $62.5 million, or ($0.65) per share for the comparable periods in 2015.
Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2016 combined with the anticipated proceeds from future sales of our common stock under our $60 million sales agreement with Cantor Fitzgerald & Co. are sufficient to meet estimated working capital requirements and fund planned operations through 2018.
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 2016 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 53265640.
A replay of the call will be available approximately two hours after the live call concludes through August 15, 2016. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 53265640. The webcast will also be archived on the Company's website.
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.
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 glembatumumab vedotin ("glemba"; CDX-011), varlilumab ("varli"; CDX-1127) and other products and our goals for 2016. 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, our ability to successfully complete research and further development and commercialization of 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 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 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 OF||Ended June 30,||Ended June 30,|
|Product Development and|
|Contracts and Grants||785||1,844||1,635||1,988|
|Research and Development||25,711||26,490||53,158||51,615|
|General and Administrative||7,790||8,184||17,097||14,273|
|Amortization of Acquired Intangible Assets||254||254||507||507|
|Total Operating Expense||33,755||34,928||70,762||66,395|
|Investment and Other Income, Net||414||391||1,445||1,198|
|Basic and Diluted Net Loss per|
|Weighted Average Common|
|SHEETS DATA||June 30,||December 31,|
|Cash, Cash Equivalents and Marketable Securities||$||220,128||$||289,889|
|Other Current Assets||8,654||5,047|
|Property and Equipment, net||11,293||11,461|
|Intangible and Other Assets, net||31,131||31,187|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total Liabilities and Stockholders' Equity||$||271,206||$||337,584|
Company Contact Sarah Cavanaugh Vice President of Investor Relations & Corp Communications Celldex Therapeutics, Inc. (781) 433-3161 firstname.lastname@example.org Charles Liles Associate Director of Investor Relations & Corp Communications Celldex Therapeutics, Inc. (781) 433-3107 email@example.com Media Inquiries Dan Budwick Pure Communications, Inc. (973) 271-6085 firstname.lastname@example.org