DICERNA PHARMACEUTICALS, INC. (NASDAQ:DRNA) Files An 8-K Entry into a Material Definitive AgreementItem 1.01.
The Company believes that the Oligo Restrictions will not have any material impact on either the GalXC™ RNAi technology platform or the Company’s plans for clinical development:
| • | DCR-PHXC, an investigational treatment for all forms of primary hyperoxaluria, is currently in Phase 1 clinical trials with proof-of-concept data expected in the second half of 2018. |
| • | DCR-HBVS, an investigational treatment for chronic hepatitis B virus, is in pre-clinical development and the Company anticipates filing an investigational new drug (“IND”) application or clinical trial application (“CTA”) during the fourth quarter of 2018. |
| • | An undisclosed rare disease program, which the Company intends to advance into clinical trials in conjunction with a collaborator, with an anticipated IND or CTA filing in the second half of 2018. |
As of March31, 2018, the Company had cash, cash equivalents and held-to-maturity investments of $97.8million.
The information in this Item 1.01 is intended to be furnished and shall not be deemed “filed” for purposes of Section18 of the Exchange Act or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act. The information contained herein shall not be incorporated by reference into any filing with the United States Securities and Exchange Commission (“SEC”) made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Cautionary Note on Forward-Looking Statements
This Current Report on Form 8-K includes forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Examples of forward-looking statements include, among others, statements we make regarding: the impact of the Oligo Restrictions on the GalXC™ platform and the Company’s development plans, the timing of data and IND or CTA filings, and the timing of the $13million payment to Alnylam. Applicable risks and uncertainties include those relating to our research and development, such as that our discovery-stage and preclinical programs do not advance into the clinic or result in approved products on a timely or cost effective basis or at all, and other risks identified under the heading “Risk Factors” included in our most recent Form 10-K filing and in other future filings with the SEC. The forward-looking statements contained in this Current Report on Form 8-K reflect the Company’s current views with respect to future events, and the Company does not undertake and specifically disclaims any obligation to update any forward-looking statements.
About DICERNA PHARMACEUTICALS, INC. (NASDAQ:DRNA)
Dicerna Pharmaceuticals, Inc. is a ribonucleic acid (RNA) interference-based biopharmaceutical company. The Company operates in the segment of discovery, research and development of treatments based on its RNA interference (RNAi) technology platform. The Company is focused on the discovery and development of treatments for rare inherited diseases involving the liver and for cancers that are genetically defined. The Company uses its RNAi technology platform to build a pipeline in these therapeutic areas. The Company develops dacryocystorhinostomy (DCR)-Primary Hyperoxaluria Type 1 (PH1) for the treatment of PH1 by targeting the gene encoding the liver enzyme glycolate oxidase. The Company uses its dicer substrate RNA (DsiRNA)-EX Conjugate technology to develop a subcutaneously injected treatment for PH1. The Company develops DCR-MYC for the treatment of MYC-related cancers, including hepatocellular carcinoma (HCC) and pancreatic neuroendocrine tumors (PNET).
