This Current Report on Form 8-K (this “Current Report”) updates the Annual Report on Form 10-K of Dicerna Pharmaceuticals Inc (NASDAQ:DRNA) for the year ended December 31, 2015 (the “2015 Annual Report”) and Dicerna’s most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (the “ 2016 2nd Quarter Report”) to reflect, among other things, the following:
Effective in the third quarter of 2016, Dicerna will focus its resources on its GalXCTM RNAi platform, for the treatment of rare diseases involving the liver and for other therapeutic areas involving the liver, such as chronic liver diseases, cardiovascular diseases and viral infectious diseases.
Under this plan, Dicerna will transition its primary hyperoxaluria (PH) development program to focus on DCR-PHXC, a subcutaneously delivered GalXC clinical candidate, which was announced earlier this year. The Company will discontinue its development program for DCR-PH1, an investigational therapy formulated in an EnCoreTM lipid nanoparticle (LNP) delivery system obtained through a licensing agreement with Arbutus Biopharma Corporation (formerly known as Tekmira Pharmaceuticals Corporation). Based on the DCR-PH1 proof-of-concept data in humans, the utility of the GalXC platform, and the DCR-PHXC preclinical data, the Company believes DCR-PHXC has the potential to be a better therapeutic candidate for patients with PH.
The Company will also discontinue clinical development of DCR-MYC, a DsiRNA-based therapeutic formulated as an LNP for delivery to solid tumors, because preliminary results do not meet the Company’s expectations for further development. In addition to DCR-MYC, Dicerna has a second oncology program, DCR-BCAT, which targets the WNT-beta-catenin pathway. Given the Company’s focus on advancing its GalXC-based programs, Dicerna will seek strategic alternatives to further develop DCR-BCAT, which employs an improved and enhanced EnCore LNP delivery capability, compared to earlier versions of the technology.
The preceding and certain other information is filed hereunder as Exhibit 99.1 and Exhibit 99.2 which are incorporated herein by reference. Item 9.01 of this Current Report updates the information contained in Part I, Item 1, “Business” in the 2015 Annual Report and in Part II, Item 1A, “Risk Factors” in the 2016 2nd Quarter Report.
By virtue of this Current Report, the Company will be able to incorporate the updated information by reference into future registration statements or post-effective amendments to existing registration statements. This Current Report does not update for any other changes since the filing of the 2015 Annual Report and the 2016 2nd Quarter Report.
