...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Zacks SCR Resverlogix Report 12/16/16

Regarding Financing:

"We note that at current cash burn rates, Resverlogix does not have sufficient cash to complete the fiscal year. Management has outlined several financial options that they are currently exploring which we list below:

  • Co-development or follow on compounds with major pharmaceutical company would provide upfront payment and coverage of future expenses.
  • Licensing on a regional basis would provide upfront payments
  • Licensing certain new or orphan indications to partners for upfront payment
  • Partnering and offering first right of refusal in an M&A transaction for an upfront payment
  • Private placements with equity and warrants
  • Public offering of equity, potentially with an IPO on a US Exchange (less likely)
  • Debt financing (less likely)

We anticipate that Resverlogix will favor the options in the order they are presented above and expect execution on one or more in the next quarter or two."

 

Regarding BETonMACE:

"BETonMACE will initially be conducted in Argentina, Mexico and various European cities with expansion into Asia through the partnership with Hepalink. U.S. sites are also a consideration as Resverlogix looks towards FDA approval in this adaptive trial that will target a minimum of 2,400 patients. Argentina, Belgium, Bulgaria, Croatia, Germany, Hungary, Israel, Mexico, Poland, Serbia, and Slovakia have already received regulatory approval to open clinical investigator sites and are recruiting patients. The company expects Taiwan to be added to the list of open sites in (calendar year) 1Q:17 through its relationship with Hepalink which will provide a bridge to the eventual registry of the drug in mainland China. Russia will also be added with 20 sites and 200 patients starting in the first calendar quarter of 2017. Based on implied enrollment rates, we think BETonMACE can reach the 1,000 mark by year end 2016.

RVX has also been working with the FDA on adding the United States to the BETonMACE study. Several meetings, including a Type C meeting took place between Resverlogix and the FDA over the late summer and fall. In late fall, the company made the final submission of the required immunotox report which should set things up for a January to March 2017 response from the FDA prior to beginning trials in the United States."

 

Regarding Renal Phase 2 Trial:

"If maintained on a tight timeline, the Phase 2 trial may generate results by late 2017 to early 2018 followed shortly thereafter by a Phase 3 study. Due to the high number of events seen in high risk dialysis patients, the Phase 3 trial may be sufficiently statistically powered with 1,500 enrollees, which compares to the 2,400 targeted in the BETonMACE trial. If maintained on a strict schedule and enrollment rates are favorable, Phase 3 renal could produce results by late 2019 or 2020."

Share
New Message
Please login to post a reply