Get Started for Free Contexxia identifies hard-to-find pieces of information in SEC filings. No more highlighters, no more redlining, no more poring over huge documents. IntelGenx Technologies Corp. (1098880) 10-Q published on May 14, 2020 at 4:06 pm
On January 09, 2020, the Company entered into a Feasibility Study Agreement with an undisclosed partner focused on bringing innovative animal health products to the market. Pursuant to the Agreement, IntelGenx will conduct a feasibility study on an undisclosed molecule for buccal absorption using IntelGenx's proprietary VetaFilm™ platform. Based on successful feasibility, the Company will have exclusive rights to further develop, manufacture and supply the developed product to the Partner.
On January 15, 2020, the Company announced that Health Canada had issued a No Objection Letter in response to IntelGenx's amended Clinical Trial Application for the ongoing Montelukast VersaFilm® Phase 2a clinical trial in patients with mild to moderate Alzheimer's Disease. IntelGenx's amended CTA was based on additional efficacy testing of Montelukast in an AD mouse model, conducted in collaboration with Prof. Dr. Ludwig Aigner's group at the Paracelsus Medical University in Salzburg. As reported in the manuscript entitled, Montelukast dose-dependently improves cognitive outcome in the 5xFAD mouse model of Alzheimer's Disease1, overall results demonstrated that the treatment effect was dose-dependent, with higher doses of Montelukast significantly increasing the mice's cognition in two behavioural tests.
On February 11, 2020, the Company announced the closing of the offering of 16,317,000 units at a price of C$0.50 per Unit for gross proceeds of C$8,158,500. Each Unit consists of one share of common stock and one warrant entitling the holder to purchase one share of common stock of the Company at an exercise price of C$0.75 per share. The Warrants are exercisable since closing and will expire on the third anniversary of the date of their issuance.
The units were distributed under a short form prospectus dated January 27, 2020 filed by the Company in connection with the offering and available on SEDAR at www.sedar.com and have been registered with the United States Securities and Exchange Commission pursuant to a Form S-1 Registration Statement that was declared effective on January 31, 2020. The offering was conducted, on a best efforts basis, by Echelon Wealth Partners Inc. In consideration for the services rendered by the agent, the Company paid the agent an agency fee equal to 7% of the gross proceeds of the offering and issued the agent a number of warrants equal to 7% of the number of units issued under the offering.
On March 27, 2020, the Company announced that it received a Complete Response Letter from the U.S. Food and Drug Administration regarding its resubmitted 505(b)(2) New Drug Application ("NDA") for RIZAPORT® VersaFilm® for the treatment of acute migraines. The CRL stated that the FDA cannot approve the application in its present form. The Agency requested additional information, but no new bioequivalence study. We requested a meeting with the FDA to discuss the CRL comments, with the goal of obtaining clarification and determining next steps.
The net cash provided by financing activities was $5,048 for the three-month period ended March 31, 2020, compared to $138 net cash used in financing activities in the same period of the previous year. An amount of $5,564 derives from the proceeds from public offering (2019: $nil) and an amount of $Nil derives from proceeds from exercise of warrants and stock options (2019: $21) offset by repayment of term loans for an amount of $196 (2019: $159) and the transaction costs related to the public offering of $320 (2019: $Nil).