UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM
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CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
On February 28, 2022, Celldex Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the fourth quarter and year ended 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.
(d) Exhibits
| 99.1 | Press Release of Celldex Therapeutics, Inc., dated February 28, 2022. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
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: February 28, 2022 | By: | /s/ Sam Martin |
| Sam Martin | ||
| Senior Vice President and Chief Financial Officer | ||
EXHIBIT 99.1
Celldex Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update
HAMPTON, N.J., Feb. 28, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update.
“Celldex made significant progress over the past year in advancing our pipeline, as marked by successful clinical results from our Phase 1b study with CDX-0159 demonstrating a 95% complete response rate in chronic inducible urticaria, and we remain excited to report data from our chronic spontaneous urticaria Phase 1b study early this summer,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “In July 2021, we raised $287 million in gross proceeds from a public offering which provides us with a very strong foundation to further develop our scientific and clinical programs. After successfully completing key readiness activities, including the development of a CDX-0159 subcutaneous formulation, we remain on track to initiate our Phase 2 urticaria programs in the second quarter of 2022.”
Mr. Marucci continued, “With encouraging results and multiple ongoing studies across all our programs, we are focused on executing our development plan and are well positioned for a transformational year.”
Program 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.
Corporate Highlights
Fourth Quarter and Twelve Months 2021 Financial Highlights and 2022 Guidance
Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2021 were $408.3 million compared to $423.1 million as of September 30, 2021. The decrease was primarily driven by cash used in operating activities of $14.5 million. At December 31, 2021, Celldex had 46.7 million shares outstanding.
Revenues: Total revenue was $0.3 million in the fourth quarter of 2021 and $4.7 million for the year ended December 31, 2021, compared to $3.8 million and $7.4 million for the comparable periods in 2020. The decrease in revenue was primarily due to a decrease in revenue from product development and licensing agreements as a result of 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 and a decrease in services performed under our contract manufacturing and research and development agreements with Rockefeller University and Gilead Sciences.
R&D Expenses: Research and development (R&D) expenses were $14.7 million in the fourth quarter of 2021 and $53.3 million for the year ended December 31, 2021, compared to $10.4 million and $42.5 million for the comparable periods in 2020. The increase in R&D expenses was primarily due to an increase in clinical trial, contract research, and personnel expenses.
G&A Expenses: General and administrative (G&A) expenses were $6.2 million in the fourth quarter of 2021 and $20.5 million for the year ended December 31, 2021, compared to $3.6 million and $14.5 million for the comparable periods in 2020. The increase in G&A expenses was primarily due to higher stock-based compensation and legal expenses.
Intangible Asset Impairment: The Company recorded a non-cash impairment charge of $3.5 million related to the TAM program IPR&D asset in the third quarter of 2021 as a result of a lack of interest in the program from third parties. The Company recorded a non-cash impairment charge of $14.5 million related to the TAM IPR&D asset in the fourth quarter of 2020 as a result of changes in the projected development and regulatory timelines for the program. The Company recorded a non-cash impairment charge of $3.5 million during the second quarter of 2020 due to the discontinuation of the CDX-3379 program.
Changes in Fair Value Remeasurement of Contingent Consideration: During the year ended December 31, 2021, the Company recorded a $1.4 million gain on fair value remeasurement of contingent consideration primarily due to updated assumptions for the TAM program, partially offset by losses related to changes in discount rates and the passage of time.
Net Loss: Net loss was $20.1 million, or ($0.43) per share, for the fourth quarter of 2021, and $70.5 million, or ($1.64) per share, for the year ended December 31, 2021, compared to a net loss of $21.9 million, or ($0.55) per share, for the fourth quarter of 2020 and $59.8 million, or ($2.02) per share, for the year ended December 31, 2020.
Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2021 are sufficient to meet estimated working capital requirements and fund planned operations through 2025.
Webcast and Conference Call
Celldex executives will host a conference call at 4:30 p.m. ET today to discuss business and financial results and to provide an update on key 2022 objectives. The conference call 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 2177774.
A replay of the call will be available approximately two hours after the live call concludes. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 217774. The webcast will also be archived on the Company's website.
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, including CDX-0159, in current or future indications; 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 effects of the outbreak of COVID-19 on our business and results of operations; 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.
Company Contact
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
scavanaugh@celldex.com
Patrick Till
Senior Director, Investor Relations & Corporate Communications
(484) 788-8560
ptill@celldex.com
| CELLDEX THERAPEUTICS, INC. | |||||||||||||||||
| (In thousands, except per share amounts) | |||||||||||||||||
| Consolidated Statements | Three Months | Year | |||||||||||||||
| of Operations Data | Ended December 31, | Ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||
| (Unaudited) | |||||||||||||||||
| Revenues: | |||||||||||||||||
| Product development and | |||||||||||||||||
| licensing agreements | $ | 1 | $ | 3 | $ | 31 | $ | 2,301 | |||||||||
| Contracts and grants | 332 | 3,783 | 4,620 | 5,117 | |||||||||||||
| Total revenues | 333 | 3,786 | 4,651 | 7,418 | |||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | 14,678 | 10,425 | 53,311 | 42,534 | |||||||||||||
| General and administrative | 6,241 | 3,623 | 20,488 | 14,456 | |||||||||||||
| Intangible asset impairment | - | 14,500 | 3,500 | 18,000 | |||||||||||||
| (Gain) loss on fair value remeasurement | |||||||||||||||||
| of contingent consideration | (245 | ) | 18 | (1,405 | ) | (4,218 | ) | ||||||||||
| Total operating expenses | 20,674 | 28,566 | 75,894 | 70,772 | |||||||||||||
| Operating loss | (20,341 | ) | (24,780 | ) | (71,243 | ) | (63,354 | ) | |||||||||
| Investment and other income, net | 193 | 1,941 | 505 | 2,407 | |||||||||||||
| Net loss before income tax benefit | (20,148 | ) | (22,839 | ) | (70,738 | ) | (60,947 | ) | |||||||||
| Income tax benefit | - | 939 | 227 | 1,167 | |||||||||||||
| Net loss | $ | (20,148 | ) | $ | (21,900 | ) | $ | (70,511 | ) | $ | (59,780 | ) | |||||
| Basic and diluted net loss per | |||||||||||||||||
| common share | $ | (0.43 | ) | $ | (0.55 | ) | $ | (1.64 | ) | $ | (2.02 | ) | |||||
| Shares used in calculating basic | |||||||||||||||||
| and diluted net loss per share | 46,691 | 39,577 | 42,870 | 29,640 | |||||||||||||
| Condensed Consolidated | |||||||||||||||||
| Balance Sheet Data | December 31, | December 31, | |||||||||||||||
| 2021 | 2020 | ||||||||||||||||
| Assets | |||||||||||||||||
| Cash, cash equivalents and marketable securities | $ | 408,250 | $ | 194,422 | |||||||||||||
| Other current assets | 2,589 | 3,421 | |||||||||||||||
| Property and equipment, net | 3,551 | 3,815 | |||||||||||||||
| Intangible and other assets, net | 30,264 | 34,180 | |||||||||||||||
| Total assets | $ | 444,654 | $ | 235,838 | |||||||||||||
| Liabilities and stockholders' equity | |||||||||||||||||
| Current liabilities | $ | 16,528 | $ | 14,206 | |||||||||||||
| Long-term liabilities | 8,650 | 12,275 | |||||||||||||||
| Stockholders' equity | 419,476 | 209,357 | |||||||||||||||
| Total liabilities and stockholders' equity | $ | 444,654 | $ | 235,838 | |||||||||||||
Cover |
Feb. 28, 2022 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Feb. 28, 2022 |
| Entity File Number | 000-15006 |
| Entity Registrant Name | Celldex Therapeutics, Inc. |
| Entity Central Index Key | 0000744218 |
| Entity Tax Identification Number | 13-3191702 |
| Entity Incorporation, State or Country Code | DE |
| Entity Address, Address Line One | Perryville III Building, 53 Frontage Road, Suite 220 |
| Entity Address, City or Town | Hampton |
| Entity Address, State or Province | NJ |
| Entity Address, Postal Zip Code | 08827 |
| City Area Code | 908 |
| Local Phone Number | 200-7500 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Common Stock, par value $.001 |
| Trading Symbol | CLDX |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |