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): May 6, 2021
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 May 6, 2021, Celldex Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the first quarter of 2021. 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 May 6, 2021, Celldex Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the first quarter of 2021. 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: May 6, 2021||By:||/s/ Sam Martin|
|Senior Vice President and|
Chief Financial Officer
Celldex Reports First Quarter 2021 Financial Results and Provides Corporate Update
HAMPTON, N.J., May 06, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.
“We are very encouraged by the recently reported positive interim results from our ongoing Phase 1b study of CDX-0159 in chronic inducible urticaria. These data demonstrated an 80% complete response rate and a well-tolerated safety profile, which we believe is a significant accomplishment in this complex disease setting with limited treatment options,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “Based on these exciting results, we recently amended the protocol to add a third cohort in cholinergic urticaria, a debilitating disease affecting mainly young adults, where passive or active sweating induces hives and can severely impair their quality of life. We are nearing completion of patient dosing across both the cold induced and symptomatic dermographism cohorts from this study and look forward to presenting updated results from these cohorts this summer.”
Mr. Marucci continued, “We are also making progress advancing our bispecific platform, presenting promising preclinical data at AACR that supports the development of clinical bispecific candidates that co-target ILT4 and PD-(L)1. We look forward to continuing these efforts while also exploring important targets controlling inflammation and auto-immune pathways.”
Recent Pipeline Highlights
CDX-0159 - KIT Inhibitor Program
CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.
CDX-1140 - CD40 Agonist Program
CDX-1140 is a potent CD40 human agonist antibody developed by Celldex that the Company believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.
CDX-527 - Bispecific Antibody Program
CDX-527 is the first candidate developed by Celldex from its bispecific platform which utilizes the Company’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.
While Celldex’s clinical development programs have not been significantly, negatively impacted by COVID-19 to date, the Company continues to carefully monitor the evolving situation closely across all development programs and work to minimize potential impact/disruptions.
First Quarter 2021 Financial Highlights and 2021 Guidance
Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2021 were $176.1 million compared to $194.4 million as of December 31, 2020. The decrease was primarily driven by first quarter cash used in operating activities of $18.1 million. At March 31, 2021, Celldex had 39.6 million shares outstanding.
Revenues: Total revenue was $0.7 million in the first quarter of 2021 compared to $2.7 million for the comparable period in 2020. The decrease in revenue was primarily due to the $1.8 million milestone payment received from Rockefeller University in the first quarter of 2020 related to Celldex’s manufacturing and development services agreement.
R&D Expenses: Research and development (R&D) expenses were $12.7 million in the first quarter of 2021 compared to $11.7 million for the comparable period in 2020. The increase in R&D expenses was primarily due to an increase in contract research and clinical trial expenses.
G&A Expenses: General and administrative (G&A) expenses were $4.1 million in the first quarter of 2021 compared to $3.7 million for the comparable period in 2020. The increase in G&A expenses was primarily due to higher stock-based compensation expense.
Changes in Fair Value Remeasurement of Contingent Consideration: During the quarter ended March 31, 2021, the Company recorded a $0.5 million loss on fair value remeasurement of contingent consideration primarily due to changes in discount rates and the passage of time.
Net Loss: Net loss was $16.5 million, or ($0.42) per share, for the first quarter of 2021 compared to a net loss of $12.6 million, or ($0.73) per share, for the comparable period in 2020.
Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2021 are sufficient to meet estimated working capital requirements and fund planned operations through 2023.
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 a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with inflammatory diseases and many forms of cancer. 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; the effects of the outbreak of COVID-19 on our business and results of operations; 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 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; our ability to continue to obtain 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; 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
Senior Director, Investor Relations & Corporate Communications
|CELLDEX THERAPEUTICS, INC.|
|(In thousands, except per share amounts)|
|Consolidated Statements||Three Months|
|of Operations Data||Ended March 31,|
|Product development and|
|Contracts and grants||682||442|
|Research and development||12,720||11,695|
|General and administrative||4,121||3,666|
|Loss on fair value remeasurement|
|of contingent consideration||483||234|
|Total operating expenses||17,324||15,595|
|Investment and other income, net||101||242|
|Basic and diluted net loss per|
|Shares used in calculating basic|
|and diluted net loss per share||39,614||17,406|
|Balance Sheet Data||March 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||176,083||$||194,422|
|Other current assets||5,416||3,421|
|Property and equipment, net||3,747||3,815|
|Intangible and other assets, net||33,819||34,180|
|Liabilities and stockholders' equity|
|Total liabilities and stockholders' equity||$||219,065||$||235,838|