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Celldex Therapeutics(CLDX) - 2020 Q1 - Quarterly Report
2020-05-06 20:16
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 March 31, 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. (E ...
Celldex Therapeutics(CLDX) - 2019 Q4 - Annual Report
2020-03-26 20:09
Part I [Business](index=6&type=section&id=Item%201.%20Business) Celldex Therapeutics develops immunotherapies and targeted biologics for cancer and other diseases, with four key drug candidates [Overview](index=6&type=section&id=Overview) - Celldex Therapeutics is a biopharmaceutical company developing immunotherapies and targeted biologics derived from human and bispecific antibodies to treat cancer and other diseases[13](index=13&type=chunk) - The company's key development programs are **CDX-1140**, **CDX-3379**, **CDX-0159**, and **CDX-527**, all of which are fully owned by Celldex[14](index=14&type=chunk)[15](index=15&type=chunk)[17](index=17&type=chunk) - The company has a history of operating losses and has not yet generated commercial revenues from its drug candidates[18](index=18&type=chunk) [Clinical Development Programs](index=7&type=section&id=Clinical%20Development%20Programs) - **CDX-1140**, a **CD40 agonist**, has completed dose escalation in a **Phase 1 study**. The recommended dose is **1.5 mg/kg** for both monotherapy and in combination with **CDX-301**. Expansion cohorts, including a combination with **KEYTRUDA®** (pembrolizumab), are ongoing[19](index=19&type=chunk)[22](index=22&type=chunk)[29](index=29&type=chunk) - **CDX-3379**, an **ErbB3 inhibitor**, is in a **Phase 2 study** for advanced HNSCC. Interim data showed notable clinical activity, including a durable complete response, particularly in patients with FAT1 gene mutations[30](index=30&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk) - **CDX-0159**, a **KIT inhibitor** for mast cell-driven diseases, initiated a **Phase 1a study** in healthy subjects in **November 2019**. The company plans to study it in chronic spontaneous urticaria (CSU) and chronic inducible urticarias (CINDUs) by **year-end 2020**[38](index=38&type=chunk)[41](index=41&type=chunk) - **CDX-527** is a bispecific antibody coupling **CD27** co-stimulation with **PD-L1** blockade. A **Phase 1 dose-escalation study** in patients with advanced solid tumors is planned for the **second half of 2020**[43](index=43&type=chunk)[45](index=45&type=chunk) [Partnerships and License Agreements](index=10&type=section&id=Partnerships%20and%20License%20Agreements) - The company may enter into co-development and commercialization partnerships to advance its drug candidates, leveraging external resources and capabilities[46](index=46&type=chunk) - Celldex has a license agreement with the University of Southampton for rights to develop human antibodies towards **CD27** (used in **CDX-527**), with potential milestone payments up to **$1.0 million** and low-single-digit royalties[51](index=51&type=chunk) - An agreement with Amgen provides exclusive rights to **CDX-301**, with potential milestones up to **$0.9 million** and low-single-digit royalties[52](index=52&type=chunk) - Under an agreement with MedImmune for **CDX-3379**, Celldex may be required to pay up to **$45.0 million** in regulatory and development milestones and up to **$125.0 million** in sales-based milestones, plus tiered royalties from high single-digits to low teens[54](index=54&type=chunk) [Competition, Manufacturing, and Commercialization](index=12&type=section&id=Competition%2C%20Manufacturing%2C%20and%20Commercialization) - The biotechnology and pharmaceutical industry is intensely competitive, with Celldex facing competition from large pharmaceutical companies and specialized firms that possess substantially greater financial, technical, and human resources[57](index=57&type=chunk) - Celldex operates its own **cGMP manufacturing facility** in Fall River, Massachusetts, to produce drug substance for early-stage (**Phase 1** and **Phase 2**) clinical trials, including for **CDX-1140**, **CDX-301**, **CDX-527**, and **CDX-0159**[65](index=65&type=chunk) - For late-stage trials and commercialization, the company relies on **Contract Manufacturing Organizations (CMOs)**, which limits control over the manufacturing process and introduces risks related to cost, quality, and supply chain reliability[64](index=64&type=chunk)[68](index=68&type=chunk) - The company has limited commercial experience and may choose to build its own commercial organization or pursue strategic partnerships to sell, market, and distribute its drug candidates upon approval[70](index=70&type=chunk) [Patents, Licenses and Proprietary Rights](index=14&type=section&id=Patents%2C%20Licenses%20and%20Proprietary%20Rights) - The company's intellectual property strategy involves filing patent applications, licensing rights from others, and relying on trade secrets to protect its technology[71](index=71&type=chunk) - Key patent applications for **CDX-1140** are pending in the U.S. and major international territories, with estimated expiry dates in **2037** if issued[73](index=73&type=chunk) - Patents for **CDX-3379**, licensed from MedImmune, have been issued in the U.S., Europe, and Japan with estimated expiry dates in **2032**[74](index=74&type=chunk) - A U.S. patent for **CDX-0159** has been issued with an estimated expiry date in **2034**, with other patents issued or pending internationally[77](index=77&type=chunk) - The company relies on confidentiality agreements with employees, consultants, and advisors to protect unpatented technology and trade secrets[89](index=89&type=chunk) [Government Regulation](index=17&type=section&id=Government%20Regulation) - The company's activities and products are significantly regulated by governmental entities, primarily the **U.S. Food and Drug Administration (FDA)**, requiring substantial time and financial resources for product development and approval[90](index=90&type=chunk)[91](index=91&type=chunk) - The **FDA** approval process for a new drug or biologic generally involves preclinical testing, submitting an **Investigational New Drug (IND) application**, and conducting three sequential phases of human clinical trials (**Phase 1**, **Phase 2**, and **Phase 3**) before submitting a **Biologics License Application (BLA)**[93](index=93&type=chunk)[96](index=96&type=chunk) - The **FDA** offers special procedures to expedite development and review, including **Fast Track designation**, **Priority Review**, **Accelerated Approval**, and **Breakthrough Therapy designation**, for drugs that address serious conditions and unmet medical needs[106](index=106&type=chunk)[107](index=107&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk) - Post-approval, products are subject to continuing regulation by the **FDA**, including requirements for recordkeeping, reporting adverse events, **cGMP** compliance for manufacturing, and restrictions on marketing and promotion[115](index=115&type=chunk)[117](index=117&type=chunk)[119](index=119&type=chunk) - Marketing products outside the U.S. requires compliance with varying regulatory requirements of other countries, such as the **European Medicines Agency (EMA)** in the EU, which has its own processes for marketing authorization and orphan drug designation[134](index=134&type=chunk)[135](index=135&type=chunk) [Employees and Research and Development](index=27&type=section&id=Employees%20and%20Research%20and%20Development) - As of **December 31, 2019**, Celldex employed **130 people**, with **108 engaged in or directly supporting research and development activities**[145](index=145&type=chunk) Research and Development Expenses (2017-2019) | Year | R&D Expense (in millions) | |:---|:---| | **2019** | **$42.7** | | **2018** | **$66.4** | | **2017** | **$96.2** | [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial financial, development, commercialization, and IP risks, raising going concern doubts [Risks Related to Our Financial Condition and Capital Requirements](index=27&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition%20and%20Capital%20Requirements) - There is **substantial doubt about the company's ability to continue as a going concern**, as cash resources are only expected to fund operations into the **first quarter of 2021**. This may hinder the ability to obtain future financing[150](index=150&type=chunk)[151](index=151&type=chunk) - The company has no product revenue, an **accumulated deficit of $1.0 billion** as of **December 31, 2019**, and expects to incur future losses, requiring it to raise additional capital to fund operations[154](index=154&type=chunk)[156](index=156&type=chunk) - Future milestone payments of up to **$127.5 million** to former Kolltan stockholders may be paid in cash or stock. Paying in stock would cause substantial dilution, while paying in cash would likely require raising additional capital[162](index=162&type=chunk)[163](index=163&type=chunk) [Risks Related to Development and Regulatory Approval of Drug Candidates](index=30&type=section&id=Risks%20Related%20to%20Development%20and%20Regulatory%20Approval%20of%20Drug%20Candidates) - The company's long-term success is heavily dependent on completing R&D and obtaining regulatory approval, but clinical failure can occur at any stage, and success in early trials does not guarantee success in later trials[166](index=166&type=chunk)[167](index=167&type=chunk)[177](index=177&type=chunk) - Health epidemics, such as the COVID-19 coronavirus outbreak, could significantly disrupt preclinical studies and clinical trials by delaying patient enrollment and affecting third-party service providers and manufacturers[169](index=169&type=chunk)[170](index=170&type=chunk) - The drug development and approval process is lengthy, costly, and subject to extensive regulatory scrutiny from the **FDA** and other authorities, with no guarantee of success[173](index=173&type=chunk)[175](index=175&type=chunk)[176](index=176&type=chunk) - Development of certain drug candidates may depend on the successful validation and approval of companion diagnostics, which are regulated as medical devices and face their own development and approval challenges[192](index=192&type=chunk)[193](index=193&type=chunk) [Risks Related to Commercialization of Our Drug Candidates](index=36&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Drug%20Candidates) - The company lacks sufficient marketing, sales, and distribution capabilities and may not succeed in building a commercial organization or entering into successful strategic partnerships[205](index=205&type=chunk)[206](index=206&type=chunk) - Even if approved, drug candidates may not achieve broad market acceptance from physicians, patients, and third-party payors, which is critical for generating significant revenue[207](index=207&type=chunk)[208](index=208&type=chunk) - Market acceptance and sales will depend on reimbursement policies from government authorities and private insurers, who are increasingly focused on containing healthcare costs and may not provide sufficient coverage[216](index=216&type=chunk)[217](index=217&type=chunk) - Failure to obtain regulatory approvals in foreign jurisdictions will prevent the company from marketing its products internationally, and the approval process varies significantly by country[223](index=223&type=chunk)[224](index=224&type=chunk) [Risks Related to Reliance on Third Parties](index=40&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) - The company relies on third parties like contract research organizations (CROs) to conduct clinical trials, and their failure to perform could delay or invalidate testing[229](index=229&type=chunk)[230](index=230&type=chunk) - The company has limited commercial manufacturing experience and depends on **Contract Manufacturing Organizations (CMOs)** for late-stage clinical and commercial supplies, creating risks related to cost, quality, and supply chain reliability[231](index=231&type=chunk)[232](index=232&type=chunk) - Reliance on third parties requires sharing trade secrets, which increases the risk of competitors discovering proprietary information through breaches of confidentiality agreements or other means[244](index=244&type=chunk)[245](index=245&type=chunk) [Risks Related to Our Capital Stock](index=53&type=section&id=Risks%20Related%20to%20Our%20Capital%20Stock) - The company's history of losses (**accumulated deficit of $1.0 billion**) and uncertainty of future profitability make its common stock a highly speculative investment[315](index=315&type=chunk) - A **one-for-fifteen reverse stock split** was completed in **February 2019** to regain **NASDAQ** compliance, but there is no assurance the stock price will remain compliant or that liquidity will not be adversely affected[318](index=318&type=chunk)[321](index=321&type=chunk)[324](index=324&type=chunk) - The market price of the common stock has been and could remain highly volatile, fluctuating between a high of **$11.62** and a low of **$2.01** per share in **2019** (split-adjusted)[323](index=323&type=chunk) - The ability to use net operating loss carryforwards is subject to substantial annual limitations due to ownership change rules under **Section 382** of the Internal Revenue Code[331](index=331&type=chunk)[332](index=332&type=chunk) [Properties](index=56&type=section&id=Item%202.%20Properties) Celldex leases four key properties for its operations, including headquarters, office/lab spaces, and a manufacturing facility Significant Leased Properties | Property Location | Use | Approx. Square Feet | Lease Expiration | |:---|:---|:---:|:---| | Hampton, NJ | Headquarters, Office & Lab | 33,400 | **July 2025** | | Needham, MA | Office & Lab | 46,700 | **July 2020** | | Fall River, MA | Manufacturing Facility | 33,900 | **July 2021** | | New Haven, CT | Office & Lab | 17,700 | **April 2022** | [Legal Proceedings](index=56&type=section&id=Item%203.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - Celldex is not currently involved in any material legal proceedings[341](index=341&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=57&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Celldex's common stock trades on **NASDAQ** under 'CLDX', underwent a reverse split in **2019**, and does not pay dividends - The company's common stock trades on the **Nasdaq** Capital Market (**NASDAQ**) under the symbol "CLDX"[343](index=343&type=chunk) - A **one-for-fifteen reverse stock split** of the common stock was effected on **February 8, 2019**[343](index=343&type=chunk) - The company has not paid any dividends since its inception and does not plan to pay any in the foreseeable future[343](index=343&type=chunk) [Selected Financial Data](index=57&type=section&id=Item%206.%20Selected%20Financial%20Data) Five-year financial data shows consistent net losses, a significant **2018** increase, and declining assets and equity Selected Financial Data (2015-2019) | (In thousands, except per share amounts) | **2019** | **2018** | **2017** | **2016** | **2015** | |:---|---:|---:|---:|---:|---:| | **Statements of Operations Data** | | | | | | | Total Revenue | **$3,573** | **$9,538** | **$12,743** | **$6,786** | **$5,480** | | Research and Development | **$42,672** | **$66,449** | **$96,171** | **$102,726** | **$100,171** | | Operating Loss | **$(55,031)** | **$(156,436)** | **$(121,527)** | **$(132,916)** | **$(129,541)** | | Net Loss | **$(50,878)** | **$(151,184)** | **$(93,031)** | **$(128,530)** | **$(127,197)** | | Basic and Diluted Net Loss Per Share | **$(3.51)** | **$(14.48)** | **$(10.86)** | **$(18.99)** | **$(19.66)** | | **Balance Sheet Data (at year-end)** | | | | | | | Working Capital | **$55,055** | **$86,477** | **$117,020** | **$160,346** | **$264,696** | | Total Assets | **$122,933** | **$155,809** | **$315,624** | **$383,358** | **$337,584** | | Total Stockholders' Equity | **$94,026** | **$124,060** | **$236,369** | **$265,431** | **$290,105** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=59&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial results, noting a reduced **2019** net loss, but emphasizes significant liquidity concerns and going concern doubts [Results of Operations](index=68&type=section&id=Results%20of%20Operations) Comparison of Operations (2019 vs. 2018) | (In thousands) | **2019** | **2018** | Change ($) | Change (%) | |:---|---:|---:|---:|---:| | Total Revenue | **$3,573** | **$9,538** | **$(5,965)** | **(63)%** | | R&D Expense | **$42,672** | **$66,449** | **$(23,777)** | **(36)%** | | G&A Expense | **$15,426** | **$19,269** | **$(3,843)** | **(20)%** | | Goodwill Impairment | **$0** | **$90,976** | **$(90,976)** | **(100)%** | | Operating Loss | **$(55,031)** | **$(156,436)** | **$(101,405)** | **(65)%** | | Net Loss | **$(50,878)** | **$(151,184)** | **$(100,306)** | **(66)%** | - The decrease in net loss in **2019** was primarily due to the absence of the **$91.0 million** non-cash goodwill impairment charge and **$18.7 million** intangible asset impairment charge recorded in **2018** related to the discontinuation of the **Glemba** program[414](index=414&type=chunk)[423](index=423&type=chunk) - The increase in net loss in **2018** compared to **2017** was primarily due to the goodwill impairment charge and a significantly lower non-cash income tax benefit, partially offset by lower R&D expenses[429](index=429&type=chunk) [Liquidity and Capital Resources](index=73&type=section&id=Liquidity%20and%20Capital%20Resources) - The company had **$64.4 million** in cash, cash equivalents, and marketable securities as of **December 31, 2019**[444](index=444&type=chunk) - Existing cash is expected to fund operations only into the **first quarter of 2021**, which raises **substantial doubt about the company's ability to continue as a going concern**[444](index=444&type=chunk)[446](index=446&type=chunk) - Net cash used in operating activities decreased to **$46.4 million** in **2019** from **$75.2 million** in **2018**, primarily due to lower R&D and G&A expenses[448](index=448&type=chunk) - The company raised **$16.2 million** in net proceeds in **2019** through its controlled equity offering sales agreement with Cantor Fitzgerald & Co[458](index=458&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=76&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's short-term, high-quality investment portfolio faces immaterial market risk from interest rate changes, with no derivative use - The company's investment portfolio is sensitive to market risk, but this exposure is not considered material due to the short-term nature of the investments[465](index=465&type=chunk)[467](index=467&type=chunk) - Investments consist primarily of money market mutual funds, municipal bonds, U.S. government agency securities, and high-grade corporate bonds[465](index=465&type=chunk)[467](index=467&type=chunk) - The company does not utilize derivative financial instruments[468](index=468&type=chunk) [Financial Statements and Supplementary Data](index=78&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited financial statements and the auditor's report are presented, noting fair presentation but expressing substantial doubt about the company's going concern ability [Report of Independent Registered Public Accounting Firm](index=78&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) - The independent auditor, PricewaterhouseCoopers LLP, issued an opinion that the consolidated financial statements present fairly, in all material respects, the financial position of the company[471](index=471&type=chunk) - The auditor's report includes a paragraph expressing **substantial doubt about the company's ability to continue as a going concern** due to recurring losses, cash outflows from operations, and the need to raise additional capital[472](index=472&type=chunk) [Consolidated Financial Statements](index=80&type=section&id=Consolidated%20Financial%20Statements) Consolidated Balance Sheet Highlights (as of Dec 31) | (In thousands) | **2019** | **2018** | |:---|---:|---:| | Cash, Cash Equivalents & Marketable Securities | **$64,383** | **$94,022** | | Total Assets | **$122,933** | **$155,809** | | Total Liabilities | **$28,907** | **$31,749** | | Total Stockholders' Equity | **$94,026** | **$124,060** | Consolidated Statement of Operations Highlights (Year Ended Dec 31) | (In thousands) | **2019** | **2018** | **2017** | |:---|---:|---:|---:| | Total Revenues | **$3,573** | **$9,538** | **$12,743** | | R&D Expense | **$42,672** | **$66,449** | **$96,171** | | Goodwill Impairment | **$0** | **$90,976** | **$0** | | Operating Loss | **$(55,031)** | **$(156,436)** | **$(121,527)** | | Net Loss | **$(50,878)** | **$(151,184)** | **$(93,031)** | Consolidated Cash Flow Highlights (Year Ended Dec 31) | (In thousands) | **2019** | **2018** | **2017** | |:---|---:|---:|---:| | Net Cash Used in Operating Activities | **$(46,415)** | **$(75,235)** | **$(99,931)** | | Net Cash Provided by Investing Activities | **$17,080** | **$29,816** | **$46,468** | | Net Cash Provided by Financing Activities | **$16,257** | **$29,441** | **$51,290** | | Net Decrease in Cash and Cash Equivalents | **$(13,078)** | **$(15,978)** | **$(2,173)** | [Notes to Financial Statements](index=85&type=section&id=Notes%20to%20Financial%20Statements) - Note 1 reiterates that conditions raise **substantial doubt about the company's ability to continue as a going concern**, as existing cash is only sufficient to fund operations into **Q1 2021**[494](index=494&type=chunk) - Note 8 details the full impairment of goodwill (**$91.0 million**) and a finite-lived intangible asset (**$6.9 million**) in **Q1 2018** following the discontinuation of the **Glemba** program[559](index=559&type=chunk)[564](index=564&type=chunk) - Note 15 explains that as of **Dec 31, 2019**, the company had federal and state net operating loss carryforwards of **$638.9 million** and **$595.1 million**, respectively, though their utilization is subject to limitation under **Section 382**[605](index=605&type=chunk)[606](index=606&type=chunk) - Note 17 discusses the Kolltan acquisition and the remaining potential contingent milestone payments of up to **$127.5 million**. A dispute with former Kolltan stockholders over the abandonment of certain milestones is ongoing[613](index=613&type=chunk)[614](index=614&type=chunk) [Controls and Procedures](index=110&type=section&id=Item%209A.%20Controls%20and%20Procedures) The CEO and CFO concluded that disclosure controls and internal control over financial reporting were effective as of **December 31, 2019** - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of **December 31, 2019**[620](index=620&type=chunk) - Management concluded that the company's **internal control over financial reporting** was effective as of **December 31, 2019**, based on the **COSO framework**[623](index=623&type=chunk) Part III [Directors, Executive Officers, Compensation, and Corporate Governance](index=112&type=section&id=Items%2010-14) Information on directors, executive officers, compensation, and corporate governance is incorporated by reference from the **2020** Proxy Statement - Information regarding Directors, Executive Officers, Corporate Governance (Item 10), Executive Compensation (Item 11), Security Ownership (Item 12), Certain Relationships and Related Transactions (Item 13), and Principal Accountant Fees and Services (Item 14) is incorporated by reference from the forthcoming **2020** Proxy Statement[627](index=627&type=chunk)[628](index=628&type=chunk)[629](index=629&type=chunk)[630](index=630&type=chunk)[631](index=631&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=113&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all Form 10-K exhibits, with financial statements in Item 8 and schedules omitted as not applicable - This item lists all financial statements, schedules, and exhibits filed as part of the Form 10-K[633](index=633&type=chunk) - Financial statement schedules are omitted because the required information is not applicable or is included within the main financial statements and notes[633](index=633&type=chunk)
Celldex Therapeutics(CLDX) - 2019 Q3 - Quarterly Report
2019-11-12 14:01
[Part I — Financial Information](index=3&type=section&id=Part%20I%20%E2%80%94%20Financial%20Information) [Unaudited Financial Statements](index=4&type=section&id=Item%201.%20Unaudited%20Financial%20Statements) Presents Celldex Therapeutics' unaudited condensed consolidated financial statements for the period ending September 30, 2019, detailing financial position and performance [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Financial Metric | Sep 30, 2019 (in thousands) | Dec 31, 2018 (in thousands) | | :--- | :--- | :--- | | Cash and Cash Equivalents | $16,586 | $24,310 | | Marketable Securities | $56,332 | $69,712 | | **Total Current Assets** | **$75,103** | **$99,079** | | **Total Assets** | **$131,841** | **$155,809** | | Total Current Liabilities | $11,888 | $12,602 | | **Total Liabilities** | **$30,461** | **$31,749** | | **Total Stockholders' Equity** | **$101,380** | **$124,060** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric (in thousands, except per share) | Three Months Ended Sep 30, 2019 | Three Months Ended Sep 30, 2018 | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $546 | $941 | $2,686 | $7,774 | | Research and Development | $11,101 | $11,918 | $32,333 | $55,242 | | General and Administrative | $3,403 | $3,722 | $12,207 | $14,936 | | Goodwill Impairment | $0 | $0 | $0 | $90,976 | | Operating Loss | $(11,844) | $(7,764) | $(42,042) | $(144,313) | | **Net Loss** | **$(11,413)** | **$(7,243)** | **$(40,431)** | **$(141,781)** | | **Basic and Diluted Net Loss Per Share** | **$(0.75)** | **$(0.66)** | **$(2.92)** | **$(14.12)** | [Condensed Consolidated Statements of Cash Flow](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flow) | Cash Flow Activity (in thousands) | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $(35,415) | $(59,805) | | Net Cash Provided by Investing Activities | $13,856 | $26,468 | | Net Cash Provided by Financing Activities | $13,835 | $25,872 | | **Net Decrease in Cash and Cash Equivalents** | **$(7,724)** | **$(7,465)** | | **Cash and Cash Equivalents at End of Period** | **$16,586** | **$32,823** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) - The company believes its cash, cash equivalents, and marketable securities of **$72.9 million** as of September 30, 2019, will be sufficient to fund planned operations for at least the next twelve months[14](index=14&type=chunk) - A one-for-fifteen reverse stock split of the company's common stock was effected on February 8, 2019, with all share and per-share amounts retroactively adjusted in the financial statements[15](index=15&type=chunk) - During the nine months ended September 30, 2019, the company issued **3.9 million shares** of common stock under its controlled equity offering sales agreement with Cantor, resulting in net proceeds of **$13.8 million**[43](index=43&type=chunk) - In the first quarter of 2019, the company recorded a non-cash impairment charge of **$1.8 million** related to an investment in a private company due to the deterioration of its financial condition[41](index=41&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operational results, and strategic focus on key drug candidates and clinical development programs [Overview](index=19&type=section&id=OVERVIEW) - Celldex is a biopharmaceutical company focused on developing and commercializing immunotherapies and other targeted biologics for cancer and other diseases with unmet needs[67](index=67&type=chunk) - The company is concentrating its resources on the research and development of three primary drug candidates: CDX-1140 (CD40 agonist), CDX-3379 (ErbB3 inhibitor), and CDX-0159 (KIT inhibitor)[68](index=68&type=chunk) - All development programs are currently fully owned by Celldex, aligning with its strategy to maximize value by either retaining full economic rights or entering into favorable commercial partnerships[70](index=70&type=chunk) [Clinical Development Programs](index=21&type=section&id=Clinical%20Development%20Programs) - CDX-1140: The Phase 1 monotherapy dose escalation is complete, with a recommended Phase 2 dose of 1.5 mg/kg, and a combination cohort with KEYTRUDA® is planned to open in Q1 2020[85](index=85&type=chunk)[92](index=92&type=chunk) - CDX-3379: A Phase 2 study in HNSCC showed a durable complete response, and the study has been expanded to evaluate biomarkers (FAT1/NOTCH mutations) that may be associated with antitumor activity[98](index=98&type=chunk)[100](index=100&type=chunk)[102](index=102&type=chunk) - CDX-0159: A Phase 1a study in healthy subjects is planned to start by year-end 2019, with subsequent plans to study its efficacy in Chronic Idiopathic Urticaria (CIU)[104](index=104&type=chunk) - Varlilumab: Future development is focused on creating a bispecific antibody that combines PD-1 blockade with a CD27 agonist, leveraging extensive experience from previous studies[108](index=108&type=chunk) [Results of Operations](index=26&type=section&id=RESULTS%20OF%20OPERATIONS) - For Q3 2019, net loss increased to **$11.4 million** from **$7.2 million** in Q3 2018, mainly due to a smaller gain on the fair value remeasurement of contingent consideration[114](index=114&type=chunk)[115](index=115&type=chunk) - For the nine months ended Sep 30, 2019, net loss decreased to **$40.4 million** from **$141.8 million** in the prior-year period, primarily due to the absence of large non-cash goodwill (**$91.0 million**) and intangible asset (**$18.7 million**) impairment charges recorded in 2018[125](index=125&type=chunk)[126](index=126&type=chunk) | R&D Expense Change (Nine Months Ended Sep 30, 2019 vs 2018) | Change (in thousands) | Percentage Change | | :--- | :--- | :--- | | Personnel | $(5,931) | (26)% | | Product Development | $(12,588) | (75)% | | **Total R&D Expense** | **$(22,909)** | **(41)%** | [Liquidity and Capital Resources](index=29&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) - As of September 30, 2019, the company had **$72.9 million** in cash, cash equivalents, and marketable securities[138](index=138&type=chunk) - Management believes its current cash position is sufficient to fund planned operations through 2020[138](index=138&type=chunk) - The company plans to raise additional capital through licensing, business combinations, or equity/debt offerings to meet future liquidity needs beyond 2020[139](index=139&type=chunk) - Net cash used in operating activities for the first nine months of 2019 was **$35.4 million**, a decrease from **$59.8 million** in the same period of 2018, primarily due to lower R&D and G&A expenses[140](index=140&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's financial instruments, primarily cash and marketable securities, are exposed to market risk, though management deems interest rate risk immaterial due to short-term investments - The company's investment portfolio is used to preserve capital for funding operations and consists of cash, money market funds, and short-term, high-grade securities[148](index=148&type=chunk) - Due to the short-term nature of its investments, the company does not believe it has material exposure to market risk from interest rate changes[148](index=148&type=chunk) - The company does not utilize derivative financial instruments[149](index=149&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2019, with no material changes to internal controls during the quarter - The CEO and CFO concluded that as of September 30, 2019, the company's disclosure controls and procedures were effective at a reasonable assurance level[151](index=151&type=chunk) - No material changes were made to the internal control over financial reporting during the quarter ended September 30, 2019[152](index=152&type=chunk) [Part II — Other Information](index=32&type=section&id=Part%20II%20%E2%80%94%20Other%20Information) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) Refers investors to previously disclosed risk factors in the 2018 Form 10-K, noting no material changes during the period - The company states there were no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K filed on March 7, 2019[156](index=156&type=chunk) - Investors are directed to the risk factors section in the 2018 Form 10-K for a comprehensive understanding of potential risks affecting the business, financial condition, or future results[155](index=155&type=chunk) [Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q report, including CEO and CFO certifications and XBRL data files, which are incorporated by reference - The report lists exhibits filed with the Form 10-Q, including CEO/CFO certifications (Exhibits 31.1, 31.2), Section 1350 certifications (Exhibit 32.1), and XBRL data files (Exhibit 101)[154](index=154&type=chunk)[157](index=157&type=chunk)
Celldex Therapeutics(CLDX) - 2019 Q2 - Earnings Call Transcript
2019-08-08 05:13
Financial Data and Key Metrics Changes - In Q2 2019, the net loss was $11.8 million or $0.84 per share, compared to a net loss of $16.4 million or $1.67 per share in Q2 2018, indicating an improvement in financial performance [26] - For the six months ended June 30, 2019, the net loss was $29 million or $2.21 per share, compared to $134.5 million or $14.01 per share for the same period in 2018, reflecting a significant reduction in losses [26] - Research and development expenses were $21.2 million for the six months ended June 30, 2019, down from $43.3 million in the comparable period in 2018, showing cost management efforts [26] - General and administrative expenses decreased to $8.8 million for the six months ended June 30, 2019, from $11.2 million in the same period in 2018 [26] - As of June 30, 2019, the company reported cash, cash equivalents, and marketable securities of $81.3 million, which are expected to be sufficient to meet working capital requirements through 2020 [27] Business Line Data and Key Metrics Changes - The company has two programs advancing in the clinic, a third expected to enter clinical trials before year-end, and a fourth planned for 2020, indicating a robust pipeline [5] - CDX-1140 is in a Phase I trial with encouraging results, demonstrating strong biological activity associated with CD40 activation [10][11] - CDX-3379 is undergoing a Phase II study in combination with cetuximab for cetuximab-resistant head and neck cancer, showing notable clinical activity in a difficult-to-treat patient population [21][22] Market Data and Key Metrics Changes - The prevalence of chronic idiopathic urticaria (CIU) is estimated to be 0.5% to 1% of the total population in the U.S., indicating a significant market opportunity for CDX-0159 [14] - The company is exploring the potential of CDX-0159 in CIU, which presents a need for more effective therapies [15] Company Strategy and Development Direction - The company is consolidating its Massachusetts laboratory and manufacturing facilities, which is expected to save over $3.5 million annually starting in the second half of 2020 [7] - The focus on advancing the clinical development of its product pipeline is evident, with plans to initiate a Phase I study of CDX-0159 before year-end and to advance bispecific programs [29] - The company aims to validate a biomarker strategy in head and neck cancer through the expansion of the CDX-3379 study, which could change the standard of care for these patients [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of CDX-1140 and CDX-3379 programs, anticipating key clinical insights within the next 6 to 12 months [28] - The company is pleased with the expanding breadth and depth of its pipeline, which is expected to support significant news flow and meaningful inflection points in the coming months [30] Other Important Information - The company made a significant hire by bringing Dr. Diane Young on board as Senior Vice President and Chief Medical Officer, which is expected to strengthen clinical development efforts [6] Q&A Session Summary Question: Safety profile of CDX-1140 and comparison with competitors - Management confirmed that while biological activity associated with CD40 activation has increased with higher doses, they have not reached a level where safety has become limiting [33][34] Question: Population sizes for FAT1 and NOTCH mutations and commercial diagnostics - Management indicated that FAT1 mutations are seen in about a third of head and neck tumors, while NOTCH mutations are present in about a quarter, and they are pursuing next-generation sequencing to confirm these findings [36][37]
Celldex Therapeutics(CLDX) - 2019 Q2 - Quarterly Report
2019-08-07 20:06
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 x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000-15006 CELLDEX THER ...
Celldex Therapeutics(CLDX) - 2019 Q1 - Quarterly Report
2019-05-07 20:31
Table of Contents 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 March 31, 2019 OR o 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 incorporat ...
Celldex Therapeutics(CLDX) - 2018 Q4 - Earnings Call Transcript
2019-03-08 03:21
Celldex Therapeutics, Inc. (NASDAQ:CLDX) Q4 2018 Results Earnings Conference Call March 7, 2019 4:30 PM ET Company Participants Sarah Cavanaugh - Senior Vice President, Corporate Affairs and Administration Anthony Marucci - Co-Founder, President, Chief Executive Officer Tibor Keler - Co-Founder, Executive Vice President, and Chief Scientific Officer Sam Martin - Senior Vice President and Chief Financial Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Operator Good day, ladies and gentle ...
Celldex Therapeutics(CLDX) - 2018 Q4 - Annual Report
2019-03-07 21:11
PART I [Item 1. Business](index=6&type=section&id=Item%201.%20Business) Celldex Therapeutics develops immunotherapies and targeted biologics for cancer, advancing four key drug candidates [Overview](index=6&type=section&id=Overview) Celldex Therapeutics develops cancer immunotherapies, focusing on four drug candidates after discontinuing others - Celldex Therapeutics, Inc. is a biopharmaceutical company developing and commercializing immunotherapies and targeted biologics for cancer and other diseases[13](index=13&type=chunk) - Current pipeline focus includes **CDX-1140, CDX-3379, CDX-301, and Varlilumab**[14](index=14&type=chunk) - Discontinued development of glembatumumab vedotin, CDX-014, and CDX-1401 in Q2 2018 following the failure of the Phase 2b METRIC Study of glembatumumab vedotin[16](index=16&type=chunk) [Clinical Development Programs](index=7&type=section&id=Clinical%20Development%20Programs) This section details the clinical development status of Celldex's key drug candidates [CDX-1140](index=7&type=section&id=CDX-1140) CDX-1140, a CD40 agonist antibody, is in Phase 1 development, showing dose-dependent immune activation - CDX-1140 is a fully human agonist monoclonal antibody targeting CD40, a key activator of immune response, found on immune cells and many cancer cells[19](index=19&type=chunk) - A Phase 1 study initiated in November 2017 is enrolling up to **180 patients** with solid tumors and B cell lymphomas to determine the maximum tolerated dose (MTD) and evaluate tolerability and biologic effects[20](index=20&type=chunk) - Interim Phase 1 data (November 2018) showed dose-dependent immune activation, good tolerability, and no MTD reached, with preliminary evidence of enhanced immune activation in combination with CDX-301[22](index=22&type=chunk) [CDX-3379](index=8&type=section&id=CDX-3379) CDX-3379, an ErbB3 blocking antibody, is in Phase 2 for head and neck cancer after showing responses in earlier studies - CDX-3379 is a human monoclonal antibody designed to block ErbB3 (HER3) activity, a receptor regulating cancer cell growth and resistance to therapies[25](index=25&type=chunk) - A Phase 1a/1b study showed objective responses in combination with Erbitux (one durable complete response in head and neck cancer) and Zelboraf (two partial responses in lung cancer)[26](index=26&type=chunk) - An ongoing Phase 2 study combines CDX-3379 with Erbitux in HPV-negative, Erbitux-resistant, advanced head and neck squamous cell carcinoma patients previously treated with anti-PD1 checkpoint inhibitors, with one confirmed complete response documented in the first stage (n=13) enrollment[30](index=30&type=chunk) [Varlilumab](index=9&type=section&id=Varlilumab) Varlilumab, a CD27 agonist antibody, showed an acceptable safety profile and immunologic activity in Phase 1, with Phase 2 data showing promising results in ovarian cancer and GBM - Varlilumab is a fully human agonist monoclonal antibody activating CD27, a co-stimulatory molecule, to stimulate T cells and enhance immune response against cancer[31](index=31&type=chunk) - A Phase 1 single-agent study in **90 patients** with solid or hematologic cancers showed an acceptable safety profile and immunologic activity, with durable multi-year clinical benefit in select patients[32](index=32&type=chunk) - A Phase 1/2 combination study with Opdivo completed Phase 2 enrollment in January 2018 across various solid tumors, with ovarian cancer cohorts showing a **14% ORR** and GBM cohort data (November 2018) showing **OS12 of 50%** in unmethylated MGMT promoter patients[33](index=33&type=chunk)[35](index=35&type=chunk)[38](index=38&type=chunk) [CDX-301](index=10&type=section&id=CDX-301) CDX-301, a recombinant Flt3L, expands dendritic and hematopoietic stem cells, used as a priming agent in combination therapies - CDX-301 is a recombinant Flt3L, a hematopoietic cytokine that expands dendritic cells and hematopoietic stem cells, potentially potentiating anti-tumor responses in combination therapies[39](index=39&type=chunk) - A Phase 1 study demonstrated an acceptable safety profile and mobilization of dendritic and hematopoietic stem cells in healthy volunteers[41](index=41&type=chunk) - CDX-301 is currently used as a priming agent in the ongoing Phase 1 trial of CDX-1140 to increase cells available for CDX-1140 activation[42](index=42&type=chunk) [Development Strategy](index=11&type=section&id=Development%20Strategy) Celldex aims to develop effective immunotherapy regimens through combination therapies and seeks alliances for funding and commercialization - Celldex aims to leverage its understanding of the immune system to develop effective immunotherapy regimens through combinations of therapeutic agents[43](index=43&type=chunk) - The company seeks governmental and corporate alliances for funding and intends to commercialize products through direct selling or corporate partners to maximize portfolio value and expedite development[44](index=44&type=chunk) [Partnerships](index=11&type=section&id=Partnerships) Celldex may enter co-development and commercialization partnerships, which carry risks including termination or pursuit of competing technologies by partners - Celldex may enter co-development and commercialization partnerships to provide financial and other resources, including research, development, manufacturing, and sales/marketing capabilities[45](index=45&type=chunk) - Partnership agreements carry risks, including termination if products are not fully developed, failure to meet obligations, or partners pursuing competing technologies, which could delay or prevent commercialization[46](index=46&type=chunk)[48](index=48&type=chunk) [Research Collaboration and License Agreements](index=12&type=section&id=Research%20Collaboration%20and%20License%20Agreements) Celldex holds various license agreements for technology and patents, requiring royalty, maintenance, and milestone payments - Celldex has license agreements for technology, patents, and applications, requiring royalty payments, annual maintenance fees, patent prosecution costs, and potential future milestone payments[49](index=49&type=chunk) - Key agreements include licenses with Medarex (for varlilumab, low-to-mid single-digit royalties), University of Southampton (for CD27 antibodies, up to **$1.0 million** milestones, low single-digit royalties), Amgen (for CDX-301 and CD40L, up to **$0.9 million** milestones, low single-digit royalties), Yale University (for RTK products including CDX-3379, **$3.0 million** one-time payment, low single-digit royalties), and MedImmune (for CDX-3379, up to **$45.0 million** regulatory/development milestones, up to **$125.0 million** sales milestones, tiered high single-digit to low teens royalties)[50](index=50&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk)[55](index=55&type=chunk) [Competition](index=13&type=section&id=Competition) The biotechnology and pharmaceutical industry is highly competitive, with Celldex facing rivals possessing greater resources and faster development capabilities - The biotechnology and pharmaceutical industry is highly competitive and subject to rapid technological change[56](index=56&type=chunk) - Celldex faces competition from large pharmaceutical companies, universities, and research institutions with substantially greater financial, technical, and human resources[56](index=56&type=chunk) - Competitors may develop products more rapidly, obtain regulatory approvals faster, or acquire/license advantageous technologies, potentially hindering Celldex's market position[57](index=57&type=chunk)[58](index=58&type=chunk) [Manufacturing](index=14&type=section&id=Manufacturing) Celldex relies on Contract Manufacturing Organizations (CMOs) for large-scale production and operates its own facility for early-stage clinical trial drug substance - Celldex has limited commercial manufacturing experience and relies on Contract Manufacturing Organizations (CMOs) for large-scale production of drug candidates for late-stage clinical trials and commercialization[61](index=61&type=chunk) - The company operates its own cGMP manufacturing facility in Fall River, Massachusetts, for early-stage clinical trial drug substance (CDX-1140, CDX-301, CDX-0159)[62](index=62&type=chunk) - Reliance on third-party manufacturers limits control and ability to monitor processes, potentially leading to delays and additional costs if manufacturing needs are not met[65](index=65&type=chunk) [Commercial Organization](index=15&type=section&id=Commercial%20Organization) Celldex has limited commercial experience and plans to expand its team or pursue strategic partnerships for product commercialization - Celldex has limited commercial experience in marketing, sales, distribution, and product reimbursement[66](index=66&type=chunk) - The company may expand its commercial team to retain marketing rights and commercialize products directly or pursue strategic partnerships for development, sales, marketing, and distribution[66](index=66&type=chunk) [Patents, Licenses and Proprietary Rights](index=15&type=section&id=Patents,%20Licenses%20and%20Proprietary%20Rights) Celldex protects its intellectual property through patents, licenses, and trade secrets, but faces risks of challenges and enforcement difficulties [Patents](index=15&type=section&id=Patents) Celldex's patent strategy involves filing applications and acquiring exclusive rights, but patent enforceability and commercial benefit are not assured - Celldex's intellectual property strategy involves filing patent applications and obtaining patent rights in the U.S. and internationally, as well as acquiring exclusive rights through licenses[67](index=67&type=chunk) - The company owns or licenses over **200 granted patents and applications**, including those for CDX-1140 (expiry 2037), CDX-3379 (expiry 2032), CDX-301 (U.S. patent expiry 2020), and varlilumab (U.S. patent expiry 2034, European patent revoked but under appeal)[69](index=69&type=chunk)[7