Celldex Therapeutics(CLDX)

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Celldex Announces Upcoming Presentation of Barzolvolimab Phase 2 Results in Chronic Spontaneous Urticaria at AAAAI 2024
Newsfilter· 2024-02-05 13:01
Core Insights - Celldex Therapeutics, Inc. announced that an abstract detailing the 12-week results from its Phase 2 clinical trial of barzolvolimab for chronic spontaneous urticaria (CSU) has been accepted for presentation at the AAAAI Annual Meeting 2024 [1] - The trial aims to evaluate the efficacy and safety of barzolvolimab in patients with CSU who are resistant to antihistamines, with a total of 208 patients participating [2] Group 1 - The abstract titled "Barzolvolimab Significantly Decreases Chronic Spontaneous Urticaria Disease Activity and is Well Tolerated: Top Line Results from a Phase 2 Trial" will be presented by Dr. Marcus Maurer on February 24, 2024 [1] - The study is a randomized, double-blind, placebo-controlled trial assessing multiple dosing regimens of barzolvolimab, with patients assigned to receive either 75 mg, 150 mg, 300 mg, or placebo [2] - The primary endpoint of the study is the mean change in Urticaria Activity Score over 7 days (UAS7) from baseline to Week 12, with secondary endpoints including other safety and clinical activity assessments [2] Group 2 - A webcast presentation of the data will be hosted by the company on February 25, 2024, at 9:45 AM ET, accessible via the Celldex Therapeutics website [3] - Celldex Therapeutics is a clinical-stage biotechnology company focused on developing therapeutics that engage the human immune system to treat severe inflammatory, allergic, and autoimmune diseases [4]
Celldex Therapeutics(CLDX) - 2023 Q3 - Quarterly Report
2023-11-01 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 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 incorp ...
Celldex Therapeutics(CLDX) - 2023 Q2 - Quarterly Report
2023-08-07 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 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 incorporati ...
Celldex Therapeutics(CLDX) - 2023 Q1 - Quarterly Report
2023-05-03 16:00
Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $.001 CLDX Nasdaq Capital Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000-15006 CELLDEX THE ...
Celldex Therapeutics (CLDX) Presents At AAAAI Conference
2023-03-02 18:16
Barzolvolimab Phase 1b Multiple Ascending Dose Chronic Spontaneous Urticaria Updated Study Results AAAAI 2023 Presentation – San Antonio February 26, 2023 Safe Harbor Statement This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are st ...
Celldex Therapeutics(CLDX) - 2022 Q4 - Annual Report
2023-02-27 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 13-3191702 State or other jurisdiction of incorporat ...
Celldex Therapeutics(CLDX) - 2022 Q3 - Quarterly Report
2022-11-08 16:00
Part I — Financial Information [Unaudited Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Financial%20Statements) The unaudited financial statements reflect a decline in total assets and a significant increase in net loss for the period [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show a decrease in total assets, primarily in cash and marketable securities, from year-end 2021 to September 2022 | Balance Sheet Highlights (In thousands) | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $18,583 | $39,143 | | Marketable securities | $304,888 | $369,107 | | Total current assets | $334,599 | $410,839 | | Total assets | $369,226 | $444,654 | | **Liabilities & Equity** | | | | Total current liabilities | $16,287 | $16,528 | | Total liabilities | $23,810 | $25,178 | | Total stockholders' equity | $345,416 | $419,476 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statements of operations indicate a significant increase in net loss for both the quarter and nine-month periods, driven by higher expenses | Income Statement (In thousands, except per share) | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $407 | $153 | $744 | $4,317 | | Research and development | $21,572 | $13,557 | $59,359 | $38,633 | | General and administrative | $6,531 | $5,821 | $20,596 | $14,247 | | Litigation settlement related loss | $0 | $0 | $15,000 | $0 | | Operating loss | $(27,696) | $(20,824) | $(87,349) | $(50,903) | | Net loss | $(26,784) | $(20,452) | $(85,838) | $(50,363) | | Basic and diluted net loss per common share | $(0.57) | $(0.45) | $(1.83) | $(1.21) | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statements show a substantial increase in cash used in operating activities and a net decrease in cash for the nine-month period | Cash Flow Summary (In thousands) | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(81,970) | $(46,386) | | Net cash provided by (used in) investing activities | $58,729 | $(197,212) | | Net cash provided by financing activities | $2,681 | $271,946 | | Net (decrease) increase in cash | $(20,560) | $28,348 | | Cash and cash equivalents at end of period | $18,583 | $72,184 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes provide details on liquidity, contingent consideration adjustments, intangible assets, and a significant litigation settlement - As of September 30, 2022, the company had cash, cash equivalents, and marketable securities of **$323.5 million**, which management believes are sufficient to fund planned operations for at least the next twelve months[19](index=19&type=chunk) - The company recorded a **$6.9 million** gain on fair value remeasurement of contingent consideration for the nine months ended September 30, 2022, primarily due to the decision to deprioritize the CDX-1140 program, reducing the liability to zero[29](index=29&type=chunk)[30](index=30&type=chunk) - The carrying value of indefinite-lived intangible assets, consisting of acquired IPR&D for the anti-KIT program (barzolvolimab), was **$27.2 million** as of September 30, 2022[36](index=36&type=chunk) - On July 15, 2022, the company executed a definitive settlement agreement with SRS regarding the Kolltan acquisition, replacing up to **$172.5 million** in original milestone payments with a new structure, including an initial **$15.0 million** payment[60](index=60&type=chunk) - The new settlement terms include a **$15.0 million** payment upon successful completion of a Phase 2 trial for CDX-0159 and **$52.5 million** upon the first regulatory approval of a Surviving Company Product[61](index=61&type=chunk)[62](index=62&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's biopharmaceutical focus, clinical pipeline progress, increased operating expenses, and liquidity position [Overview](index=17&type=section&id=Overview) The overview highlights the company's biopharmaceutical focus on therapeutic antibodies for inflammatory diseases and cancer, particularly Barzolvolimab - The company is a biopharmaceutical firm developing therapeutic monoclonal and bispecific antibodies for inflammatory diseases and cancer[69](index=69&type=chunk) - Key focus is on the research and development of Barzolvolimab (CDX-0159), a monoclonal antibody targeting the KIT receptor for mast cell-driven diseases[69](index=69&type=chunk) - The company is also advancing its next-generation bispecific antibody platform for inflammatory diseases and oncology[70](index=70&type=chunk) [Clinical Development Programs](index=20&type=section&id=Clinical%20Development%20Programs) This section details the progress of key clinical programs, including Barzolvolimab's Phase 2 studies and the discontinuation of other programs - **Barzolvolimab (CDX-0159)**: Phase 2 studies in chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) were initiated in June/July 2022[83](index=83&type=chunk)[86](index=86&type=chunk) - Positive interim data from the Phase 1b CSU study showed a **75.1%** mean reduction in urticaria activity score (UAS7) at week 8 in the 3.0 mg/kg dose group[98](index=98&type=chunk)[101](index=101&type=chunk) - A Phase 1b study in prurigo nodularis (PN) began in December 2021, and a Phase 2 study in eosinophilic esophagitis (EoE) is planned for H1 2023[98](index=98&type=chunk)[101](index=101&type=chunk) - **CDX-527**: The clinical study for this bispecific antibody in ovarian cancer was closed and the program discontinued due to slow enrollment and a challenging development environment[106](index=106&type=chunk) - **CDX-1140**: The company is not progressing further company-sponsored studies for this CD40 agonist, citing pipeline priorities, and is exploring options for third-party sponsored studies[107](index=107&type=chunk) - **CDX-585**: This bispecific antibody combining PD-1 and ILT4 blockade is completing IND-enabling activities and is expected to enter the clinic in 2023[103](index=103&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Operating results show increased net losses for both the quarter and nine-month periods, driven by higher R&D and litigation expenses | Comparison (In thousands) | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $407 | $153 | $254 | 166% | | R&D Expense | $21,572 | $13,557 | $8,015 | 59% | | G&A Expense | $6,531 | $5,821 | $710 | 12% | | Net loss | $(26,784) | $(20,452) | $(6,332) | 31% | - The increase in net loss for Q3 2022 was primarily due to an **$8.0 million** increase in R&D expenses, mainly from higher barzolvolimab clinical trial and manufacturing costs[112](index=112&type=chunk)[118](index=118&type=chunk) | Comparison (In thousands) | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $744 | $4,317 | $(3,573) | -83% | | R&D Expense | $59,359 | $38,633 | $20,726 | 54% | | G&A Expense | $20,596 | $14,247 | $6,349 | 45% | | Litigation settlement loss | $15,000 | $0 | $15,000 | N/A | | Net loss | $(85,838) | $(50,363) | $(35,475) | 70% | - The **$35.5 million** increase in net loss for the nine-month period was driven by a **$15.0 million** litigation settlement loss, a **$20.7 million** increase in R&D expenses, and a **$6.3 million** increase in G&A expenses[123](index=123&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains a strong cash position, projected to fund operations through 2025, despite increased cash usage in operating activities - As of September 30, 2022, the company had **$323.5 million** in cash, cash equivalents, and marketable securities[135](index=135&type=chunk) - Management believes the current cash position is sufficient to fund planned operations through **2025**[135](index=135&type=chunk) - Net cash used in operating activities was **$82.0 million** for the nine months ended September 30, 2022, a significant increase from **$46.4 million** in the prior year period, primarily due to higher R&D/G&A expenses and the **$15.0 million** litigation settlement payment[137](index=137&type=chunk) - Net cash from financing activities decreased to **$2.7 million** in the first nine months of 2022, compared to **$271.9 million** in the same period of 2021, which had included **$269.9 million** in net proceeds from a public stock offering[140](index=140&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure is minimal, with investments focused on preserving principal and maintaining liquidity through short-term, high-grade instruments - The company's investment policy focuses on preserving principal and maintaining liquidity by investing excess cash in money market funds and high-grade, short-term marketable securities[141](index=141&type=chunk) - Due to the short-term nature of its investments, management does not believe the company has material exposure to market risk from changes in interest rates[141](index=141&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of September 30, 2022[144](index=144&type=chunk) - No changes occurred during the quarter ended September 30, 2022, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[145](index=145&type=chunk) Part II — Other Information [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors were reported, directing investors to the Annual Report on Form 10-K for comprehensive details - The company states there were no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K filed on February 28, 2022[146](index=146&type=chunk) [Other Information](index=30&type=section&id=Item%205.%20Other%20Information) The Board of Directors approved amended By-Laws, introducing a majority vote standard, enhanced stockholder proposal requirements, and exclusive forum designation - On November 3, 2022, the company's Board of Directors amended and restated its By-Laws[147](index=147&type=chunk) - Key changes to the By-Laws include adopting a 'majority of votes cast' standard for most matters, enhancing advance notice requirements for stockholder proposals, designating the Court of Chancery of the State of Delaware as the exclusive forum for most internal corporate claims, and clarifying indemnification provisions for directors and officers[147](index=147&type=chunk)[148](index=148&type=chunk) [Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including amended By-Laws, a license agreement, and officer certifications - The exhibits filed with the Form 10-Q are listed, including the Second Amended and Restated By-Laws, an amended license agreement, and certifications by the CEO and CFO[151](index=151&type=chunk)[152](index=152&type=chunk)
Celldex Therapeutics(CLDX) - 2022 Q2 - Quarterly Report
2022-08-07 16:00
Part I [Unaudited Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Financial%20Statements) The unaudited condensed consolidated financial statements for June 30, 2022, detail a $59.1 million net loss and $356.8 million in cash and equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Indicator | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents & marketable securities | $356,817 | $408,250 | | Total assets | $402,961 | $444,654 | | **Liabilities and Stockholders' Equity** | | | | Litigation settlement payable | $15,000 | $— | | Total liabilities | $37,868 | $25,178 | | Total stockholders' equity | $365,093 | $419,476 | Condensed Consolidated Statements of Operations Highlights (in thousands) | Indicator | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Total revenues | $337 | $4,165 | | Research and development | $37,786 | $25,076 | | Litigation settlement related loss | $15,000 | $— | | Operating loss | $(59,653) | $(30,078) | | Net loss | $(59,054) | $(29,911) | | Basic and diluted net loss per share | $(1.26) | $(0.76) | Condensed Consolidated Statements of Cash Flow Highlights (in thousands) | Indicator | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(46,778) | $(30,014) | | Net cash provided by investing activities | $35,661 | $29,575 | | Net decrease in cash and cash equivalents | $(10,742) | $(390) | - The company believes its cash, cash equivalents, and marketable securities of **$356.8 million** as of June 30, 2022, are sufficient to fund planned operations for at least the next twelve months[20](index=20&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operations, highlighting increased net loss due to a $15.0 million litigation settlement and higher R&D expenses, while confirming liquidity through 2025 [Overview](index=20&type=section&id=OVERVIEW) Celldex focuses on developing therapeutic antibodies like Barzolvolimab and CDX-527 for inflammatory diseases and cancer, acknowledging high development costs and long timelines - The company's primary development efforts are focused on: - **Barzolvolimab (CDX-0159)**: A monoclonal antibody for mast cell-driven diseases like Chronic Urticarias, Prurigo Nodularis (PN), and Eosinophilic Esophagitis (EoE)[68](index=68&type=chunk) - **CDX-527**: A bispecific antibody for advanced solid tumors[69](index=69&type=chunk) R&D Expense by Program (Six Months Ended June 30, in thousands) | Program | 2022 (In thousands) | 2021 (In thousands) | | :--- | :--- | :--- | | Barzolvolimab/Anti-KIT Program | $21,918 | $10,973 | | CDX-1140 and CDX-301 | $1,751 | $2,845 | | CDX-527 | $1,195 | $2,328 | | Other Programs | $12,922 | $8,930 | | **Total R&D Expense** | **$37,786** | **$25,076** | - The company estimates that clinical trials can take **1-5 years per phase**, and total development costs often exceed **$100 million** for each drug candidate[71](index=71&type=chunk)[72](index=72&type=chunk) [Clinical Development Programs](index=23&type=section&id=Clinical%20Development%20Programs) Celldex's clinical programs show Barzolvolimab progressing to Phase 2 for urticaria and expanding to other indications, while CDX-527 completes Phase 1, and CDX-1140 is deprioritized - **Barzolvolimab (CSU)**: Positive interim Phase 1b data showed a **75.1% mean reduction** in urticaria activity score (UAS7) at week 8 in the 3.0 mg/kg dose group, leading to a Phase 2 study initiation in June 2022[85](index=85&type=chunk)[89](index=89&type=chunk) - **Barzolvolimab (CIndU)**: In a Phase 1b study, **100% of patients** with cold urticaria and **89% with symptomatic dermographism** experienced a complete response after a single 3 mg/kg dose, with a Phase 2 study initiated in July 2022[92](index=92&type=chunk)[96](index=96&type=chunk) - **Barzolvolimab Expansion**: Clinical development has expanded to Prurigo Nodularis (PN) with a Phase 1b study initiated in December 2021, and a Phase 2 study in Eosinophilic Esophagitis (EoE) is planned for late 2022[98](index=98&type=chunk)[101](index=101&type=chunk) - **CDX-1140 Deprioritization**: Following a data review in June 2022, the company decided not to progress further company-sponsored studies for the CDX-1140 program, citing the need to answer questions about its optimal clinical application[108](index=108&type=chunk) [Results of Operations](index=33&type=section&id=RESULTS%20OF%20OPERATIONS) Net loss significantly increased for Q2 and H1 2022 due to a $15.0 million litigation settlement and higher R&D and G&A expenses, partially offset by a $6.9 million gain Comparison of Q2 2022 vs. Q2 2021 (in thousands) | Metric | Q2 2022 | Q2 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $163 | $3,480 | $(3,317) | (95)% | | R&D Expense | $20,731 | $12,356 | $8,375 | 68% | | G&A Expense | $7,154 | $4,306 | $2,848 | 66% | | Litigation Loss | $15,000 | $— | $15,000 | n/a | | Net Loss | $(36,004) | $(13,373) | $(22,631) | 169% | Comparison of Six Months 2022 vs. Six Months 2021 (in thousands) | Metric | H1 2022 | H1 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $337 | $4,165 | $(3,828) | (92)% | | R&D Expense | $37,786 | $25,076 | $12,710 | 51% | | G&A Expense | $14,066 | $8,426 | $5,640 | 67% | | Litigation Loss | $15,000 | $— | $15,000 | n/a | | Net Loss | $(59,054) | $(29,911) | $(29,143) | 97% | - The increase in R&D spending was primarily driven by higher clinical trial, contract manufacturing, and contract research expenses for the barzolvolimab program[119](index=119&type=chunk)[129](index=129&type=chunk) - A gain of **$6.9 million** on fair value remeasurement of contingent consideration was recorded for the six months ended June 30, 2022, primarily due to the decision to deprioritize the CDX-1140 program[130](index=130&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) Celldex held $356.8 million in cash and equivalents as of June 30, 2022, sufficient to fund operations through 2025, despite increased cash used in operating activities - The company held **$356.8 million** in cash, cash equivalents, and marketable securities at June 30, 2022[133](index=133&type=chunk) - Management believes current liquidity is sufficient to fund planned operations through **2025**, though this could be impacted by the choice to pay future milestones in cash[134](index=134&type=chunk) - Net cash used in operating activities increased to **$46.8 million** for the six months ended June 30, 2022, compared to **$30.0 million** for the same period in 2021, mainly due to higher operating expenses[137](index=137&type=chunk) - The company may raise additional capital through partnerships, debt, or equity offerings to meet long-term liquidity needs, especially considering potential future milestone payments under the SRS Settlement Agreement[136](index=136&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's short-term, high-grade investment portfolio is managed to preserve capital and liquidity, resulting in immaterial exposure to market risk, including interest rate changes - The company's investment strategy is to preserve principal and maintain liquidity by investing in money market funds, municipal bonds, U.S. government agency securities, and high-grade corporate bonds[141](index=141&type=chunk) - Due to the short-term nature of its investments, the company does not believe it has material exposure to market risk, including interest rate risk[141](index=141&type=chunk) [Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal control over financial reporting - The CEO and CFO concluded that as of June 30, 2022, the company's disclosure controls and procedures were effective[144](index=144&type=chunk) - No changes occurred during the quarter ended June 30, 2022, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[145](index=145&type=chunk) Part II [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company settled litigation with SRS regarding Kolltan acquisition milestone payments, replacing the original $172.5 million structure with a new one totaling up to $82.5 million - The company settled litigation with SRS concerning contingent milestone payments from the Kolltan acquisition, with a definitive settlement agreement executed on July 15, 2022[149](index=149&type=chunk) Revised Milestone Payment Structure vs. Original (in thousands) | Payment Trigger | New Structure | Original Structure | | :--- | :--- | :--- | | Initial Payment | $15,000,000 (paid) | N/A | | Phase 2 Completion (CDX-0159) | $15,000,000 (less $2.5M credit) | Part of up to $172.5M | | First Regulatory Approval | $52,500,000 | Part of up to $172.5M | | **Total Potential Payments** | **Up to $82.5M** | **Up to $172.5M** | - The initial **$15 million** payment was made in cash, with future payments, if due, payable in cash, stock, or a combination at the company's sole discretion[151](index=151&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported since the Annual Report on Form 10-K filed on February 28, 2022 - There were no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K filed on February 28, 2022[152](index=152&type=chunk) [Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section lists key exhibits filed with the Form 10-Q, including settlement agreements and officer certifications - Key exhibits filed with this report include the Binding Settlement Term Sheet (10.1), the Confidential Settlement Agreement and Mutual Release (10.2), and CEO/CFO certifications (31.1, 31.2)[154](index=154&type=chunk)