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Zur Macrilen Studie
On October 26, 2016, we announced the completion of patient recruitment for the Macrilen™ confirmatory Phase 3 clinical trial for the evaluation of AGHD. We currently expect to release top-line results in early 2017 and to file a New Drug Application for Macrilen™ ("NDA") with the FDA during the first half of 2017, if the results of the trial warrant doing so. The confirmatory trial is an open-label, randomized, two-way crossover study that compares the results of the evaluation of AGHD using Macrilen™ to the results of the evaluation of AGHD using a procedure known as the “Insulin Tolerance Test” (the “ITT”) on the same patient. The trial involves patients, each of whom was evaluated for AGHD using both Macrilen™ and the ITT. Thirty of the patients will be evaluated using Macrilen™ a second time to measure the repeatability of the result obtained using Macrilen™ as the evaluation method. The study population consisted of more than 110 patients who were suspected of having AGHD as a result of the presence of one or more symptoms. This segment of the population included a range of patients from those considered at low risk of having AGHD to those considered at high risk. The study population also included 25 healthy subjects, who had no risk of having AGHD. The two co-primary endpoints are “percent of negative agreement” and “percent of positive agreement” between the Macrilen™ test and the ITT. The evaluation of AGHD with Macrilen™ will be considered successful if the lower bound of the two-sided 95% confidence interval (or lower bound of the one-sided 97.5% confidence interval) for the primary efficacy variables is 75% or higher for “percent negative agreement”, and 70% or higher for the “percent positive agreement”.
The following paragraphs represent an additional short-term risk factor for the Company, which was included in the prospectus supplement for our November 2016 Offering:
We may be required to repay a portion of the proceeds of the offering to the purchaser in the event we publicly announce results of the confirmatory Phase 3 clinical trial of Macrilen on or before December 15, 2016 which results in the price of our Common Shares falling below the price per Unit
The Company has agreed with the purchaser of the Units that in the event the Company publicly announces or discloses by press release, on or before December 15, 2016, any developments relating to the confirmatory Phase 3 trial for Macrilen in the evaluation of AGHD (the ‘‘Macrilen Phase 3 Trial’’) and the volume weighted average price (‘‘VWAP’’) over the 5 days immediately following such public announcement or disclosure is less than the purchase price per Unit, then the Company will make a cash payment to the purchaser equal to the difference between the Unit price and such VWAP multiplied by the number of all Common Shares then held by such Purchaser. If the Macrilen Phase 3 Trial results are publicly announced or disclosed by the Company at any time after December 15, 2016, the Company will be under no such obligation to make any cash payment whatsoever to the purchaser. Although the Company anticipates that it is very unlikely that the results of the Macrilen Phase 3 Trial will be available prior to December 15, 2016, if they do become available and are disclosed before such date and such announcement leads to a decrease in the price of our Common Shares in the circumstances described above, we could be liable to make a substantial payment to the purchaser.
http://secfilings.nasdaq.com/...20INC.&FormType=6-K&View=html
Common shares issued in connection with "At-the-Market" ("ATM") issuances
On April 1, 2016, the Company entered into an ATM sales agreement (the "April 2016 ATM Program"), under which the Company is able, at its discretion and from time to time, to sell up to 3 million of its common shares through ATM issuances on the NASDAQ for aggregate gross proceeds of up to approximately $10 million. The ATM program provides that common shares are to be sold at market prices prevailing at the time of sale and, as a result, prices may vary. Between April 1, 2016 and September 30, 2016 , the Company issued a total of 165,096 common shares under the April 2016 ATM Program at an average price of approximately $3.52 per share for aggregate gross proceeds of approximately $0.6 million less cash transaction costs of approximately $19,000 and previously deferred transaction costs of $20,000. In connection with these issuances and in accordance with their respective anti-dilution provisions, the exercise price of the March 2015 Series A warrants was adjusted to $3.41.
Subsequent to September 30, 2016 , the Company issued an additional 426,982 common shares under the April 2016 ATM Program at an average price of approximately $4.02 per share for gross proceeds of approximately $1.7 million.
Outstanding Share Data
As at November 8, 2016 , we had 11,670,775 common shares and 950,000 pre-funded warrants exercisable for common shares issued and outstanding, as well as 324,832 stock options outstanding. Warrants outstanding as at November 8, 2016 represented a total of 3,779,245 equivalent common shares (excluding common shares issuable upon exercise of the pre-funded warrants separately disclosed above).
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