SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): November 7, 2017
Celldex Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
|(State or Other Jurisdiction of Incorporation)||(Commission File Number)||(I.R.S. Employer Identification Number)|
|Perryville III Building, 53 Frontage Road, Suite 220, Hampton, New Jersey 08827|
|(Address of Principal Executive Offices) (Zip Code)|
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report)
|Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:|
|[ ]||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|[ ]||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|[ ]||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|[ ]||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [ ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item 2.02. Results of Operations and Financial Condition.
On November 7, 2017, Celldex Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the third quarter of 2017. The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein. The information in this Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
On November 7, 2017, Celldex Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the third quarter of 2017. The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.
The information in this Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits 99.1 Press Release of Celldex Therapeutics, Inc., dated November 7, 2017.
99.1 Press Release of Celldex Therapeutics, Inc., dated November 7, 2017.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Celldex Therapeutics, Inc.|
|Date: November 7, 2017||By:||/s/ Sam Martin|
|Senior Vice President and|
Chief Financial Officer
Celldex Reports Third Quarter 2017 Results
HAMPTON, N.J., Nov. 07, 2017 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business and financial highlights for the third quarter ended September 30, 2017.
"In late August, we completed enrollment in our Phase 2 METRIC study of glembatumumab vedotin in triple negative breast cancer,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “We believe glemba holds considerable promise as a potential new targeted therapy for patients with this devastating disease and continue to look forward to topline data from this study in the second quarter of 2018. In early October, Dr. Margo Heath-Chiozzi joined Celldex to lead our global regulatory strategy. With nine product approvals under her leadership, Dr. Heath-Chiozzi brings an exceptional command of the regulatory environment and will play an important role in defining potential approval paths for glemba and our earlier pipeline.
We look forward to a busy end of year as we prepare for the glemba data read out and advance multiple earlier stage studies, including the initiation of two new studies by year-end—a Phase 2 study of CDX-3379 in recurrent head and neck squamous cell cancer and a Phase 1 study of CDX-1140 in solid tumors.”
Third Quarter and First Nine Months 2017 Financial Highlights and Updated 2017 Guidance
Cash position: Cash, cash equivalents and marketable securities as of September 30, 2017 were $140.5 million compared to $154.0 million as of June 30, 2017. The decrease was primarily driven by third quarter cash used in operating activities of $24.4 million. This decrease was partially offset by the receipt of $11.2 million from sales of common stock under the Cantor agreement. At September 30, 2017, Celldex had 132.1 million shares outstanding.
Revenues: Total revenue was $3.9 million in the third quarter of 2017 and $9.3 million for the nine months ended September 30, 2017, compared to $2.2 million and $4.9 million for the comparable periods in 2016. The increase in revenue was primarily due to the manufacturing service agreements with the International AIDS Vaccine Initiative and Frontier Biotechnologies, Inc.
R&D Expenses: Research and development (R&D) expenses were $21.9 million in the third quarter of 2017 and $72.7 million for the nine months ended September 30, 2017, compared to $25.0 million and $78.2 million for the comparable periods in 2016.
The $3.1 million decrease in third quarter R&D expenses was primarily due to decreases in varlilumab contract manufacturing and clinical trials expenses of $1.7 million and $1.0 million, respectively.
The $5.5 million decrease in year-to-date R&D expenses was primarily due to decreases in varlilumab and Rintega contract manufacturing expenses of $6.8 million and $2.5 million, respectively, partially offset by an increase in glembatumumab vedotin contract manufacturing expenses of $2.6 million and increases in personnel and facility costs related to the Kolltan acquisition.
G&A Expenses: General and administrative (G&A) expenses were $5.3 million in the third quarter of 2017 and $19.1 million for the nine months ended September 30, 2017, compared to $7.0 million and $24.0 million for the comparable periods in 2016.
The $1.7 million decrease in third quarter G&A expenses was primarily due to lower commercial planning costs of $0.7 million and lower stock-based compensation of $0.6 million.
The $4.9 million decrease in year-to-date G&A expenses was primarily due to lower commercial planning costs of $3.1 million and lower stock-based compensation of $1.4 million.
In-Process Research and Development Impairment: The Company recorded a non-cash partial impairment charge of $13.0 million on the anti-KIT program IPR&D asset acquired from Kolltan for the three months ended September 30, 2017 due to changes in the anti-KIT program projected development and regulatory timelines.
Gain on Fair Value Remeasurement of Contingent Consideration: Gain on the fair value remeasurement of contingent consideration related to the Kolltan acquisition was $4.6 million in the third quarter of 2017 and $0.2 million for the nine months ended September 30, 2017, primarily due to a reduction in fair value attributed to the milestones related to the Company’s anti-KIT program and partially offset by losses related to changes in discount rates and the passage of time.
Net loss: Net loss was $26.4 million, or ($0.20) per share, for the third quarter of 2017 and $89.2 million, or ($0.71) per share, for the nine months ended September 30, 2017, compared to a net loss of $29.6 million, or ($0.29) per share, and $96.2 million, or ($0.97) per share, for the comparable periods in 2016.
Financial guidance: Celldex believes that the cash, cash equivalents and marketable securities at September 30, 2017, combined with the $11.3 million in net proceeds from sales of common stock under the Cantor agreement during October 2017, are sufficient to meet estimated working capital requirements and fund planned operations through 2018; however, this guidance assumes Celldex elects to pay future Kolltan contingent milestones, if any, in stock rather than cash.
Xeloda® is a registered trademark of Genentech, Inc. Opdivo® is a registered trademark of Bristol-Myers Squibb. Keytruda® is a registered trademark of Merck Sharp & Dohme Corp. 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 includes antibodies, antibody-drug conjugates and other protein-based therapeutics derived from a broad set of complementary technologies which have the ability to engage the human immune system and/or directly inhibit tumors to treat specific types of cancer or other diseases. 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, our ability to successfully complete research and further development and commercialization of glembatumumab vedotin and other Company 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; our ability to realize the anticipated benefits from the acquisition of Kolltan and to operate the combined business efficiently; 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)|
|CONDENSED CONSOLIDATED STATEMENTS||Three Months||Nine Months|
|OF OPERATIONS DATA||Ended September 30,||Ended September 30,|
|Product Development and|
|Contracts and Grants||2,686||1,727||6,799||3,362|
|Research and Development||21,915||25,009||72,707||78,168|
|General and Administrative||5,346||6,950||19,109||24,049|
|In-Process Research and Development Impairment||13,000||-||13,000||-|
|Gain on Fair Value Remeasurement|
|of Contingent Consideration||(4,600||)||-||(200||)||-|
|Amortization of Acquired Intangible Assets||224||254||672||760|
|Total Operating Expense||35,885||32,213||105,288||102,977|
|Investment and Other Income, Net||398||395||1,611||1,841|
|Net Loss Before Income Tax Benefit||(31,563||)||(29,598||)||(94,390||)||(96,223||)|
|Income Tax Benefit||5,200||-||5,200||-|
|Basic and Diluted Net Loss per|
|Shares Used in Calculating Basic|
|and Diluted Net Loss per Share||129,640||100,672||125,856||99,398|
|BALANCE SHEETS DATA||September 30,||December 31,|
|Cash, Cash Equivalents and Marketable Securities||$||140,530||$||189,776|
|Other Current Assets||6,787||5,793|
|Property and Equipment, net||11,308||13,192|
|Intangible and Other Assets, net||160,793||174,597|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total Liabilities and Stockholders' Equity||$||319,418||$||383,358|
Senior Vice President, Corporate Affairs & Administration
Celldex Therapeutics, Inc.
Associate Director, Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
Founder, 1AB Media