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):
(Exact name of registrant as specified in its charter)
|(State or Other Jurisdiction of Incorporation)||(Commission File Number)||(I.R.S. Employer Identification No.)|
(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))|
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
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, 2023, Celldex Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the fourth quarter and year ended 2022. 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.
|99.1||Press Release of Celldex Therapeutics, Inc., dated February 28, 2023.|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
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, 2023||By:||/s/ Sam Martin|
|Senior Vice President and|
Chief Financial Officer
Celldex Reports Fourth Quarter and Year End 2022 Financial Results and Provides Corporate Update
- Phase 1b multi-dose CSU data presented at AAAAI on February 26 -
- Phase 2 CSU enrollment completion expected by Q3 2023 -
HAMPTON, N.J., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2022 and provided a corporate update.
“Celldex made significant progress over the past year advancing our pipeline. We reported multiple positive data sets from our Phase 1b barzolvolimab program, including updated results from the Phase 1b multi-dose study in chronic spontaneous urticaria this past weekend at AAAAI,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “Our Phase 2 studies in both inducible and spontaneous urticaria are enrolling as planned and we expect to complete accrual of the Phase 2 CSU study by the end of the third quarter and, importantly, will be in a position to report topline data from this study either late this year or in the first quarter of 2024.”
Mr. Marucci continued, “We continue to expand the barzolvolimab program into indications where we believe its unique mechanism could potentially provide new therapeutic options to patients suffering from these difficult diseases and look forward to initiating our Phase 2 study in eosinophilic esophagitis in the first half of 2023 and to presenting Phase 1 data from our prurigo nodularis program later this year. We also made considerable progress on our bispecific platform in 2022, advancing several candidates focused on important targets in inflammatory diseases and are poised to initiate a Phase 1 study of CDX-585, our ILT4 and PD-(L)1 oncology candidate, later this year. Finally, in direct support of our growth, we recently welcomed Dr. Rita Jain to the Celldex Board of Directors and we look forward to her contributions as we continue to advance our programs into later stage development.”
Recent Business Highlights
On February 16, 2023, Celldex announced that Rita Jain, M.D. was appointed to the Company’s Board of Directors. Dr. Jain is a rheumatologist and most recently served as Executive Vice President, Chief Medical Officer of ChemoCentryx, Inc. She currently serves as a member of the Board of Directors for Provention Bio, Inc. and serves on the supervisory board of AM Pharma. Celldex believes her deep background in drug development strongly complements the current Board’s skills and experiences.
Recent Program Highlights
Barzolvolimab - KIT Inhibitor Program
Barzolvolimab 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.
Bispecific Antibody Platform
CDX-585 – Bispecific ILT4 & PD-(L)1
CDX-585 combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells. ILT4 is emerging as an important immune checkpoint on myeloid cells.
Fourth Quarter and Twelve Months 2022 Financial Highlights and 2023 Guidance
Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2022 were $305.0 million compared to $323.5 million as of September 30, 2022. The decrease was primarily driven by cash used in operating activities of $21.8 million, partially offset by proceeds from option exercises and unrealized gains due to higher interest rates. At December 31, 2022, Celldex had 47.2 million shares outstanding.
Revenues: Total revenue was $1.6 million in the fourth quarter of 2022 and $2.4 million for the year ended December 31, 2022, compared to $0.3 million and $4.7 million for the comparable periods in 2021. The decrease in revenue for the twelve months ended December 31, 2022 compared to the twelve months ended December 31, 2021 was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University and Gilead Sciences.
R&D Expenses: Research and development (R&D) expenses were $22.9 million in the fourth quarter of 2022 and $82.3 million for the year ended December 31, 2022, compared to $14.7 million and $53.3 million for the comparable periods in 2021. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial, barzolvolimab contract manufacturing, and personnel expenses.
G&A Expenses: General and administrative (G&A) expenses were $6.6 million in the fourth quarter of 2022 and $27.2 million for the year ended December 31, 2022, compared to $6.2 million and $20.5 million for the comparable periods in 2021. The increase in G&A expenses was primarily due to our settlement agreement with SRS, barzolvolimab commercial planning and stock-based compensation expenses.
Changes in Fair Value Remeasurement of Contingent Consideration: The Company recorded a $6.9 million gain on fair value remeasurement of contingent consideration for the twelve months ended December 31, 2022, primarily due to the Company’s decision to deprioritize the CDX-1140 program in the second quarter of 2022.
Litigation Settlement Related Loss: The Company recorded a one-time loss of $15.0 million in the second quarter of 2022 related to the $15.0 million paid to SRS pursuant to our settlement agreement.
Net Loss: Net loss was $26.5 million, or ($0.56) per share, for the fourth quarter of 2022, and $112.3 million, or ($2.40) per share, for the year ended December 31, 2022, compared to a net loss of $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. The litigation settlement related loss had a ($0.32) impact on net loss per share for the twelve months ended December 31, 2022. The gain on fair value remeasurement of contingent consideration had a $0.15 impact on net loss per share for the twelve months ended December 31, 2022.
Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2022 are sufficient to meet estimated working capital requirements and fund planned operations through 2025, which include our ongoing Phase 1b studies in urticaria and prurigo nodularis and our ongoing and planned Phase 2 studies in CSU, CIndU and EoE.
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 barzolvolimab (also referred to as 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.
Senior Vice President, Corporate Affairs & Administration
|CELLDEX THERAPEUTICS, INC.|
|(In thousands, except per share amounts)|
|Consolidated Statements of Operations Data||Ended December 31,||Ended December 31,|
|Product development and licensing agreements||$||26||$||1||$||56||$||31|
|Contracts and grants||1,587||332||2,301||4,620|
|Research and development||22,900||14,678||82,258||53,311|
|General and administrative||6,598||6,241||27,195||20,488|
|Intangible asset impairment||-||-||-||3,500|
|Gain on fair value remeasurement of contingent consideration||-||(245||)||(6,862||)||(1,405||)|
|Litigation settlement related loss||-||-||15,000||-|
|Total operating expenses||29,498||20,674||117,591||75,894|
|Investment and other income, net||1,398||193||2,909||505|
|Net loss before income tax benefit||(26,487||)||(20,148||)||(112,325||)||(70,738||)|
|Income tax benefit||-||-||-||227|
|Basic and diluted net loss per common share||$||(0.56||)||$||(0.43||)||$||(2.40||)||$||(1.64||)|
|Shares used in calculating basic and diluted net loss per share||47,132||46,691||46,888||42,870|
|Condensed Consolidated Balance Sheet Data||December 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||304,952||$||408,250|
|Other current assets||12,741||2,589|
|Property and equipment, net||3,747||3,551|
|Intangible and other assets, net||31,295||30,264|
|Liabilities and stockholders' equity|
|Total liabilities and stockholders' equity||$||352,735||$||444,654|