Celldex Therapeutics(CLDX)

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Celldex Therapeutics(CLDX) - 2021 Q4 - Earnings Call Transcript
2022-03-01 01:57
Celldex Therapeutics, Inc. (NASDAQ:CLDX) Q4 2021 Earnings Conference Call February 28, 2022 4:30 PM ET Company Participants Sarah Cavanaugh - Senior Vice President, Corporate Affairs and Administration Anthony Marucci - Co-founder, President and Chief Executive Officer Tibor Keler - Co-Founder and Chief Scientific Officer Diane Young - Senior Vice President and Chief Medical Officer Margo Heath-Chiozzi - Senior Vice President of Regulatory Affairs Diego Alvarado - Executive Director of Research Conference C ...
Celldex Therapeutics(CLDX) - 2021 Q2 - Quarterly Report
2021-08-04 16:00
[Part I — Financial Information](index=3&type=section&id=Part%20I%20%E2%80%94%20Financial%20Information) [Item 1. Unaudited Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Financial%20Statements) The company presents its unaudited condensed consolidated financial statements for the period ended June 30, 2021 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $204.6 million, driven by a reduction in cash and marketable securities Condensed Consolidated Balance Sheets (in thousands) | Account | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $43,446 | $43,836 | | Marketable securities | $120,591 | $150,586 | | **Total current assets** | **$167,606** | **$197,843** | | **Total assets** | **$204,551** | **$235,838** | | **Liabilities & Equity** | | | | Total current liabilities | $14,488 | $14,206 | | **Total liabilities** | **$22,269** | **$26,481** | | **Total stockholders' equity** | **$182,282** | **$209,357** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company's net loss widened to $29.9 million for the six-month period due to higher R&D expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Total revenues | $4,165 | $2,965 | | Research and development | $25,076 | $21,400 | | General and administrative | $8,426 | $7,194 | | Intangible asset impairment | $0 | $3,500 | | Operating loss | $(30,078) | $(24,231) | | **Net loss** | **$(29,911)** | **$(23,656)** | | **Net loss per share** | **$(0.76)** | **$(1.20)** | [Condensed Consolidated Statements of Cash Flow](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flow) Net cash used in operations was $30.0 million, while investing activities provided cash from sales of securities Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(30,014) | $(23,332) | | Net cash provided by (used in) investing activities | $29,575 | $(86,564) | | Net cash provided by financing activities | $49 | $166,691 | | **Net (decrease) increase in cash** | **$(390)** | **$56,795** | | **Cash at end of period** | **$43,446** | **$68,027** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail liquidity, accounting policies, a subsequent equity raise, and an ongoing legal dispute - The company believes its cash, cash equivalents, and marketable securities as of the filing date are **sufficient to fund planned operations for at least the next twelve months**[18](index=18&type=chunk) - In July 2021, subsequent to the quarter's end, the company raised approximately **$270.0 million in net proceeds** from an underwritten public offering of common stock[37](index=37&type=chunk) - The company is in a **legal dispute with Shareholder Representative Services (SRS)** over contingent milestone payments related to the Kolltan acquisition, with a trial scheduled for June 2022[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk) - Indefinite-lived intangible assets of **$30.7 million** consist of acquired In-Process Research and Development (IPR&D) related to the anti-KIT program (CDX-0159) and the TAM program[33](index=33&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the clinical pipeline, operational results, financial condition, and liquidity [Overview and Clinical Development Programs](index=18&type=section&id=Overview%20and%20Clinical%20Development%20Programs) The company is advancing its key clinical programs, including CDX-0159, CDX-1140, and CDX-527 - **CDX-0159 (anti-KIT):** Reported positive interim data from a Phase 1b study in chronic inducible urticaria (CIndU), with **95% of patients experiencing a complete response**[65](index=65&type=chunk)[84](index=84&type=chunk)[90](index=90&type=chunk) - **CDX-1140 (anti-CD40):** The recommended dose for further study was determined to be 1.5 mg/kg, with expansion cohorts ongoing[66](index=66&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) - **CDX-527 (bispecific PD-L1xCD27):** A Phase 1 study in advanced solid tumors is ongoing, with dose escalation completed[66](index=66&type=chunk)[98](index=98&type=chunk)[99](index=99&type=chunk) R&D Expense by Program (Six Months Ended June 30, in thousands) | Program | 2021 | 2020 | | :--- | :--- | :--- | | CDX-0159/Anti-KIT Program | $10,973 | $2,896 | | CDX-1140 and CDX-301 | $2,845 | $5,586 | | CDX-527 | $2,328 | $5,891 | | Other Programs | $8,930 | $7,027 | | **Total R&D Expense** | **$25,076** | **$21,400** | [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Net loss increased for the three and six-month periods due to higher R&D expenses and contingent consideration Comparison of Three Months Ended June 30 (in thousands) | Metric | 2021 | 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $3,480 | $236 | $3,244 | 1,375% | | R&D Expense | $12,356 | $9,705 | $2,651 | 27% | | G&A Expense | $4,306 | $3,528 | $778 | 22% | | **Net loss** | **$(13,373)** | **$(11,031)** | **$(2,342)** | **21%** | Comparison of Six Months Ended June 30 (in thousands) | Metric | 2021 | 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $4,165 | $2,965 | $1,200 | 40% | | R&D Expense | $25,076 | $21,400 | $3,676 | 17% | | G&A Expense | $8,426 | $7,194 | $1,232 | 17% | | **Net loss** | **$(29,911)** | **$(23,656)** | **$(6,255)** | **26%** | - The increase in R&D expenses for the six-month period was primarily due to higher clinical trial and contract research costs, particularly for the **expanded development of CDX-0159**[111](index=111&type=chunk)[122](index=122&type=chunk) - The loss on fair value remeasurement of contingent consideration was **$0.7 million for the first six months of 2021**, compared to a $4.9 million gain in the same period of 2020[123](index=123&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) The company secured significant funding through a public offering, ensuring liquidity through 2025 - At June 30, 2021, principal sources of liquidity consisted of cash, cash equivalents and marketable securities of **$164.0 million**[128](index=128&type=chunk) - The company raised approximately **$270.0 million in net proceeds** from a July 2021 underwritten public offering[128](index=128&type=chunk)[134](index=134&type=chunk) - Management believes that current cash, combined with the July 2021 offering proceeds, is **sufficient to fund planned operations through 2025**[128](index=128&type=chunk) - Net cash used in operating activities increased to **$30.0 million** for the six months ended June 30, 2021, from $23.3 million in the prior-year period, due to higher R&D and G&A expenses[130](index=130&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's investment portfolio has no material exposure to market risk due to its short-term nature - The company invests excess cash in high-grade, short-term securities and does not believe it has **material exposure to market risk**[136](index=136&type=chunk) - The company **does not use derivative financial instruments**[137](index=137&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective as of June 30, 2021**[139](index=139&type=chunk) - **No material changes** were made to the internal control over financial reporting during the quarter[140](index=140&type=chunk) [Part II — Other Information](index=40&type=section&id=Part%20II%20%E2%80%94%20Other%20Information) [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is in an ongoing legal dispute over milestone payments related to the Kolltan acquisition - Celldex is in a **legal dispute with SRS**, the representative for former Kolltan stockholders, over contingent milestone payments from the 2016 merger[142](index=142&type=chunk) - The dispute centers on whether milestone payments for the discontinued **CDX-0158 program** are owed, with SRS arguing that the current **CDX-0159 program** is effectively an extension of CDX-0158[143](index=143&type=chunk) - Mediation in May 2021 did not resolve the dispute, and the case is scheduled for **trial in June 2022**[143](index=143&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors were reported for the period - There were **no material changes** to the risk factors previously disclosed in the company's Annual Report on Form 10-K filed on March 29, 2021[144](index=144&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the quarterly report, including plans and certifications - Lists various exhibits filed with the Form 10-Q, including the 2021 Omnibus Equity Incentive Plan, various award and employment agreements, and CEO/CFO certifications[147](index=147&type=chunk)
Celldex Therapeutics(CLDX) - 2020 Q3 - Quarterly Report
2020-11-05 21:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $.001 CLDX Nasdaq Capital Market FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000-15006 CELLDEX THERAPEUTICS, INC ...
Celldex Therapeutics(CLDX) - 2020 Q2 - Earnings Call Transcript
2020-08-07 01:49
Celldex Therapeutics, Inc. (NASDAQ:CLDX) Q2 2020 Earnings Conference Call August 6, 2020 4:30 PM ET Company Participants Sarah Cavanaugh – Senior Vice President, Corporate Affairs and Administration Anthony Marucci – Co-founder, President and Chief Executive Officer Diane Young – Senior Vice President and Chief Medical Officer Sam Martin – Senior Vice President and Chief Financial Officer Margo Heath-Chiozzi – Senior Vice President, Regulatory Affairs Conference Call Participants Kristen Kluska – Cantor Fit ...
Celldex Therapeutics(CLDX) - 2020 Q2 - Quarterly Report
2020-08-06 20:21
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000-15006 CELLDEX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware No. 13-3191702 (State or other jurisdiction of incorporation or organization ...