Soligenix, Inc. announced final results are imminent from two pivotal Phase 3 clinical trials: SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL), where the company have completed enrollment and expect top-line results in first quarter of 2020; and SGX942 (dusquetide) for the treatment of oral mucositis in head and neck cancer, where The company expects to complete enrollment in first quarter of 2020 and report top-line results in second quarter of 2020. The company completed patient enrollment in pivotal Phase 3 double-blind, placebo-controlled study in CTCL with SGX301 (synthetic hypericin) in December following the positive recommendation received from the independent Data Monitoring Committee (DMC) in October 2018. Everything remains on track and focus is now to complete the treatments for all patients and to lock the study database shortly thereafter, facilitating top-line results in first quarter of 2020. The company remain encouraged by this development program as a potential front line treatment where there is currently an unmet medical need. You may recall that this trial, referred to as the "FLASH" study (Fluorescent Light Activated Synthetic Hypericin), aims to evaluate the response to SGX301 as a skin directed therapy to treat early stage CTCL. SGX301 has received Orphan Drug designation as well as Fast Track designation from the United States (US) Food and Drug Administration (FDA). Additionally, SGX301 was granted Orphan Drug designation from the European Medicines Agency (EMA) and Promising Innovative Medicine (PIM) designation from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK). Approximately 35 CTCL centers across the US, representing the major Key Opinion Leaders (KOLs) in this indication, are participating in this pivotal trial, which enrolled 169 subjects.  Although the trial begins with a double-blind, placebo-controlled portion (referred to as Cycle 1), all participants in the trial eventually receive active study drug (referred to as Cycle 2) and an optional portion of the trial is available to them to continue with SGX301 treatment (referred to as Cycle 3). We remain encouraged that the majority of patients have elected to continue with Cycle 3, the optional open-label portion of the study. We also continue to work closely with patient advocacy groups, such as the Cutaneous Lymphoma Foundation and the National Organization for Rare Disorders. The CTCL development program has received partial funding of approximately $1.5 million over two years from a Small Business Innovative Research (SBIR) grant awarded by the NIH'sNational Cancer Institute (NCI). The company continue to actively enroll patients in a pivotal Phase 3 multinational, double-blind, placebo-controlled clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy (CRT). Since enrolling first patient in December 2017 in a "controlled roll-out" of the study in the US to assure site adherence with the protocol design, the company have expanded enrollment into Europe following the same controlled process. As the company announced in August 2019, the DMC conducted an unblinded interim analysis with data from approximately 90 study subjects, including assessment of the study's primary efficacy endpoint. The DMC recommended that additional subjects be randomized into the trial to maintain the rigorous assumption of 90% statistical power for the primary efficacy endpoint. No safety concerns were reported by the DMC based on the interim analysis. Although the company do not typically give specific enrollment numbers during the active conduct of clinical trials, I am happy to say that the company currently have over 220 of the 260 subjects required to complete enrollment in this study. Consistent with public guidance, the company currently expect to complete enrollment in First Quarter 2020, with final topline results in Second Quarter 2020.  This trial, referred to as the "DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity), aims to evaluate the response of SGX942 in reducing the median duration of severe oral mucositis, in addition to other clinically meaningful measures, and incorporates feedback from the FDA as well as the EMA via the Scientific Advice process. Scientific Advice from the EMA indicated that a single, double-blind, placebo-controlled Phase 3 study, if successful, in conjunction with the positive results from the Phase 2 dose-ranging study, generally will be sufficient to support a marketing authorization application for potential licensure in Europe. SGX942 is the first Innate Defense Regulator in development for oral mucositis and has previously demonstrated positive results in a Phase 2 clinical trial.  Dusquetide is a new chemical entity with a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.  The Phase 2 data demonstrated a significant reduction in the duration of oral mucositis, as well as reduced infection rates, as published in 2016 in the Journal of Biotechnology. Long-term follow-up data from the Phase 2 trial, published in 2017 in Biotechnology Reports, further indicated the safety and tolerability of SGX942 treatment, with a sustained trend towards reduced mortality and increased tumor resolution compared to placebo. SGX942 has received Fast Track designation from the FDA for the treatment of oral mucositis as a result of CRT in HNC patients as well as PIM designation from the MHRA in the UK. Approximately 50 oncology centers in the US and Europe are actively participating in this pivotal, Phase 3 study, which is targeted to enroll 260 subjects with squamous cell carcinoma of the oral cavity and oropharynx who are scheduled to receive the standard treatment regimen with a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day and concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. The oral mucositis development program has received partial funding of approximately $1.5 million over two years from an SBIR grant awarded by the NIH'sNational Institute of Dental and Craniofacial Research (NIDCR).