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 12, 2019
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. [ ]
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock, par value $.001||CLDX||Nasdaq Capital Market|
Item 2.02. Results of Operations and Financial Condition.
On November 12, 2019, Celldex Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the third quarter of 2019. 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 12, 2019, Celldex Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the third quarter of 2019. 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.
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 12, 2019||By:||/s/ Sam Martin|
|Senior Vice President and|
Chief Financial Officer
Celldex Provides Corporate Update and Reports Third Quarter 2019 Results
HAMPTON, N.J., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business and financial highlights for the third quarter ended September 30, 2019.
“Celldex achieved a significant milestone last week, reporting data at SITC that CDX-1140 has exceeded the hurdles we defined for Phase 1 monotherapy development and has the potential to be a best in class CD40 agonist,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “We are very encouraged by the results we have seen to date across the study and have expanded the trial to more broadly explore the clinical activity we observed in head and neck squamous cell carcinoma and to include a combination cohort with KEYTRUDA under a clinical trial collaboration with Merck.
We also continue to make excellent progress in our Phase 2 program of our ErbB3 inhibitor, CDX-3379, and reported the potential for a promising biomarker strategy in head and neck squamous cell carcinoma at ASCO this summer. Earlier this month, our IND for our KIT inhibitor, CDX-0159, was accepted by the FDA and we look forward to initiating a Phase 1 trial by year-end. The positive advancements across our pipeline will continue to drive us towards multiple milestones over the next six to 18 months and we look forward to keeping our shareholders updated on our progress,” concluded Marucci.
Recent Pipeline Highlights:
CDX-1140—a potent CD40 agonist that Celldex believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.
CDX-3379—a differentiated human monoclonal antibody designed to block the activity of ErbB3 (HER3). ErbB3 is expressed in many cancers, including head and neck squamous cell cancer (HNSCC) and is believed to be an important receptor regulating cancer cell growth and survival as well as resistance to targeted therapies.
CDX-0159—a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells. In certain inflammatory diseases, such as chronic idiopathic urticaria (CIU), mast cell degranulation plays a central role in the onset and progression of the disease.
Celldex continues to advance a robust preclinical portfolio and data from the Company’s CDX-527 bispecific candidate were presented on November 9th at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting (SITC 2019). Bispecific antibodies that engage two independent pathways involved in controlling immune responses to tumors are a rapidly growing area for the development of next generation PD-1 inhibitors. CDX-527 uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway. Celldex’s prior clinical experience with combining CD27 activation and PD-1 blockade provide the rationale for linking these two pathways into one molecule. The data presented at SITC demonstrate that CDX-527 is more potent at T cell activation and anti-tumor immunity than the combination of parental monoclonal antibodies. Celldex is currently completing CDX-527 GMP manufacturing activities and IND-enabling studies and plans to file an IND in the first quarter of 2020.
Third Quarter 2019 Financial Highlights and First Nine Months 2019 Financial Highlights and 2019 Guidance
Cash Position: Cash, cash equivalents and marketable securities were $72.9 million as of September 30, 2019 compared to $81.3 million as of June 30, 2019. The decrease was primarily driven by third quarter cash used in operating activities of $11.1 million, partially offset by $2.5 million in net proceeds from sales of common stock under the Cantor agreement. At September 30, 2019, Celldex had 15.9 million shares outstanding.
Revenues: Total revenue was $0.5 million in the third quarter of 2019 and $2.7 million for the nine months ended September 30, 2019, compared to $0.9 million and $7.8 million for the comparable periods in 2018. The decrease in revenue was primarily due to lower revenue from the collaboration agreement with Bristol-Myers Squibb Company and the contract manufacturing and research and development agreements with the International AIDS Vaccine Initiative and Rockefeller University.
R&D Expenses: Research and development (R&D) expenses were $11.1 million in the third quarter of 2019 and $32.3 million for the nine months ended September 30, 2019, compared to $11.9 million and $55.2 million for the comparable periods in 2018. The decrease in R&D expenses was primarily due to lower clinical trial, personnel and contract manufacturing costs.
G&A Expenses: General and administrative (G&A) expenses were $3.4 million in the third quarter of 2019 and $12.2 million for the nine months ended September 30, 2019, compared to $3.7 million and $14.9 million for the comparable periods in 2018. The decrease in G&A expenses was primarily due to lower personnel and commercial planning costs and lower lease restructuring expense.
Changes in Fair Value Remeasurement of Contingent Consideration: The gain on fair value remeasurement of contingent consideration was $2.1 million in the third quarter of 2019 and $1.6 million for the nine months ended September 30, 2019, primarily due to changes in discount rates, the passage of time and updated assumptions for the varlilumab program.
Net Loss: Net loss was $11.4 million, or ($0.75) per share, for the third quarter of 2019, and $40.4 million, or ($2.92) per share, for the nine months ended September 30, 2019, compared to a net loss of $7.2 million, or ($0.66) per share, for the third quarter of 2018 and $141.8 million, or ($14.12) per share, for the nine months ended September 30, 2018.
Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at September 30, 2019, combined with the anticipated proceeds from future sales of common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2020. This could be impacted if Celldex elects to pay Kolltan contingent milestones, if any, in cash.
Erbitux® is a registered trademark of Eli Lilly & Co. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA.
About Celldex Therapeutics, Inc.
Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline includes immunotherapies and other targeted biologics 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 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 maintain compliance with Nasdaq listing requirements; our ability to realize the cost benefits of consolidating our office and laboratory space and to retain key personnel after that consolidation; our ability to realize the anticipated benefits from the acquisition of Kolltan; 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; 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.
Senior Vice President, Corporate Affairs & Administration
Celldex Therapeutics, Inc.
|CELLDEX THERAPEUTICS, INC.|
|(In thousands, except per share amounts)|
|CONSOLIDATED STATEMENTS||Quarter||Nine Months|
|OF OPERATIONS DATA||Ended September 30,||Ended September 30,|
|Product Development and|
|Contracts and Grants||491||810||2,307||4,982|
|Research and Development||11,101||11,918||32,333||55,242|
|General and Administrative||3,403||3,722||12,207||14,936|
|Intangible Asset Impairment||-||-||-||18,677|
|Other Asset Impairment||-||-||1,800||-|
|Gain on Fair Value Remeasurement|
|of Contingent Consideration||(2,114||)||(6,935||)||(1,612||)||(27,968||)|
|Amortization of Acquired Intangible Assets||-||-||-||224|
|Total Operating Expense||12,390||8,705||44,728||152,087|
|Investment and Other Income, Net||431||521||1,611||1,767|
|Net Loss Before Income Tax Benefit||(11,413||)||(7,243||)||(40,431||)||(142,546||)|
|Income Tax Benefit||-||-||-||765|
|Basic and Diluted Net Loss per|
|Shares Used in Calculating Basic|
|and Diluted Net Loss per Share||15,282||10,912||13,854||10,042|
|BALANCE SHEETS DATA||September 30,||December 31,|
|Cash, Cash Equivalents and Marketable Securities||$||72,918||$||94,022|
|Other Current Assets||2,185||5,057|
|Property and Equipment, net||4,488||6,111|
|Intangible and Other Assets, net||52,250||50,619|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total Liabilities and Stockholders' Equity||$||131,841||$||155,809|