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Kadmon Holdings, Inc. (KDMN) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2018

Kadmon Holdings, Inc.

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CIK: 1557142 Ticker: KDMN

Exhibit 99.1



C:\Users\ellen tremaine\Desktop\Kadmon logo - blue - 5 26 15.jpg





Kadmon Provides Business Update and Reports Fourth Quarter and Full Year 2018 Financial Results 



NEW YORK, March 7, 2019 – Kadmon Holdings, Inc. (NYSE: KDMN) today provided a business update and reported financial and operational results for the fourth quarter and full year ended December 31, 2018.

“We continued to make strong progress in advancing KD025 throughout 2018, notably reporting encouraging results from our Phase 2a study in cGVHD after receiving FDA Breakthrough Therapy Designation in October 2018,” said Harlan W. Waksal, M.D., President and CEO at Kadmon. “We are on track to complete enrollment and deliver the primary endpoint readout in our registration trial of KD025 in cGVHD in the second half of 2019.”

Dr. Waksal added, “We have started this year with great momentum: We have made key additions to our leadership team, including our CFO; we have added two highly qualified, scientific and operationally-based board members; and we are well capitalized to execute our growing development pipeline. In 2019, we plan to initiate three new clinical trials: A Phase 2 study of KD025 in systemic sclerosis; a clinical study of KD045, our next-generation pan-ROCK inhibitor for fibrotic diseases; and a clinical study of KD033, our IL-15 fusion protein for immuno-oncology. In parallel, we continue to build our organization to support our ultimate goal of helping patients with serious unmet medical needs.”

2019 Anticipated Key Clinical Milestones:

KD025

·

Complete enrollment in registration trial in cGVHD and announce readout of primary endpoint in 2H 2019

·

Continue dialogue with the U.S. Food and Drug Administration (FDA) regarding Kadmon’s regulatory strategy for KD025 in cGVHD; KD025 received Breakthrough Therapy Designation from the FDA in October 2018 and Orphan Drug Designation in August 2017 

·

Initiate double-blind, placebo-controlled Phase 2 clinical trial in systemic sclerosis (scleroderma) in 1H 2019

KD045

·

Initiate clinical trial of KD045, Kadmon’s next-generation pan-ROCK inhibitor for the treatment of fibrotic diseases, in 2H 2019

The following information was filed by Kadmon Holdings, Inc. (KDMN) on Thursday, March 7, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Kadmon Holdings, Inc.'s 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Operations
Consolidated Statements Of Stockholders' Equity
401(K) Profit-Sharing Plan
401(K) Profit-Sharing Plan (Details)
Accrued Expenses
Accrued Expenses (Narrative) (Details)
Accrued Expenses (Short-Term Accrued Expenses) (Details)
Accrued Expenses (Tables)
Commitments
Commitments (Future Minimum Rental Payments Under Noncancellable Leases) (Details)
Commitments (Narrative) (Details)
Commitments (Tables)
Concentrations
Concentrations (Details)
Contingencies
Contingencies (Narrative) (Details)
Debt
Debt (Debt Payable) (Details)
Debt (Interest Expense And Other Related Financing Costs) (Details)
Debt (Minimum Payments Required On Outstanding Balances) (Details)
Debt (Narrative) (Details)
Debt (Tables)
Financial Instruments
Financial Instruments (Fair Value Assumptions - Warrants) (Details)
Financial Instruments (Fair Values Of Financial Instruments) (Details)
Financial Instruments (Narrative) (Details)
Financial Instruments (Rollforward Of Level 2 Investments) (Details)
Financial Instruments (Tables)
Financial Instruments (Warrants Outstanding) (Details)
Fixed Assets
Fixed Assets (Fixed Assets) (Details)
Fixed Assets (Narrative) (Details)
Fixed Assets (Tables)
Goodwill And Other Intangible Assets
Goodwill And Other Intangible Assets (Narrative) (Details)
Income Taxes
Income Taxes (Effective Income Tax Rate Reconciliation) (Details)
Income Taxes (Income Tax Provision) (Details)
Income Taxes (Narrative) (Details)
Income Taxes (Net Deferred Tax Assets And Liabilities) (Details)
Income Taxes (Tables)
Inventories
Inventories (Narrative) (Details)
Inventories (Schedule Of Inventories) (Details)
Inventories (Tables)
Investment In Meiragtx
Investment In Meiragtx (Narrative) (Details)
License Agreements
License Agreements (Narrative) (Details)
Net Loss Per Share Attributable To Common Stockholders
Net Loss Per Share Attributable To Common Stockholders (Anti-Dilutive Amounts Excluded From Calculation Of Diluted Net Income (Loss) Per Share) (Details)
Net Loss Per Share Attributable To Common Stockholders (Computation Of Basic And Diluted Net Income (Loss) Per Share Attributable To Common Stockholders) (Details)
Net Loss) Per Share Attributable To Common Stockholders (Tables)
Organization
Organization (Narrative) (Details)
Quarterly Financial Data
Quarterly Financial Data (Details)
Quarterly Financial Data (Tables)
Related Party Transactions
Related Party Transactions (Details)
Share-Based Compensation
Share-Based Compensation (Narrative) (Details)
Share-Based Compensation (Stock Options Outstanding) (Details)
Share-Based Compensation (Tables)
Share-Based Compensation (Weighted-Average Fair Value Of Stock Option Awards Granted) (Details)
Stockholders??? Equity
Stockholders??? Equity (Narrative) (Details)
Subsequent Events
Subsequent Events (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Adoption Of New Accounting Pronouncements) (Details)
Summary Of Significant Accounting Policies (Disaggregation Of Revenue) (Details)
Summary Of Significant Accounting Policies (Initial Application Period Cumulative Effect Transition On Balance Sheet) (Details)
Summary Of Significant Accounting Policies (Initial Application Period Cumulative Effect Transition On Income Statement) (Details)
Summary Of Significant Accounting Policies (Narrative) (Details)
Summary Of Significant Accounting Policies (Policy)
Summary Of Significant Accounting Policies (Tables)
Ticker: KDMN
CIK: 1557142
Form Type: 10-K Annual Report
Accession Number: 0001557142-19-000020
Submitted to the SEC: Thu Mar 07 2019 11:47:38 AM EST
Accepted by the SEC: Thu Mar 07 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations

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