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Share Name | Share Symbol | Market | Type |
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Dicerna Pharmaceuticals Inc | NASDAQ:DRNA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 38.22 | 42.07 | 38.22 | 0 | 01:00:00 |
Management to Host Conference Call Today at 4:30 p.m. ET
Dicerna Pharmaceuticals, Inc. (NASDAQ: DRNA), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today reported financial and operating results for the first quarter ended March 31, 2018.
“Dicerna is off to a strong start in 2018 with the achievement of a number of important milestones for our lead GalXC™ program, DCR-PHXC, currently in development for primary hyperoxaluria,” said Douglas M. Fambrough, Ph.D., president and chief executive officer of Dicerna. “With the healthy volunteer phase of the PHYOX Phase 1 study now complete, we have initiated the second phase of the trial, and dosing of the first primary hyperoxaluria patient with DCR-PHXC is imminent. While the PHYOX study remains blinded to treatment assignment, the early safety and tolerability data in healthy volunteers are very encouraging. The FDA’s acceptance of our investigational new drug application (IND) for DCR-PHXC gives us the greenlight to expand the trial into the U.S. We expect 2018 to be an eventful year for Dicerna as we hope to achieve clinical proof-of-concept results from this multi-center study in the second half of 2018. Additionally, we look forward to achieving key milestones for our other priority programs, DCR-HBVS for chronic hepatitis B virus and an undisclosed program for a rare disease of the liver, including the filing of regulatory clearances to initiate clinical trials later this year.
“On an important note, we recently announced that we have resolved all ongoing litigation between Dicerna and Alnylam Pharmaceuticals. This settlement allows us to advance all of our existing and currently anticipated pipeline programs while maintaining a strong balance sheet. With the litigation now behind us, we are able to focus all of our resources on progressing our clinical programs, discovery programs, and partnering initiatives in accordance with our strategy and timelines. In a separate disclosure, we reported that Bruce Peacock, a member of the Board of Directors, will be stepping down from his board position at Dicerna’s Annual Meeting of Stockholders in June. I would like to thank Bruce for his service and wise counsel to the Company over the past four years and wish him well in his future endeavors.”
GalXC™ Pipeline Update
Conclusion of Litigation
Financial Condition and Operating Results
For more detailed information and analysis, see Dicerna’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, which was filed with the Securities and Exchange Commission (SEC) on May 14, 2018.
Guidance
Dicerna believes that it has sufficient cash to fund the execution of its current clinical and operating plan through 2019, which includes focusing its resources on advancing its DCR-PHXC development program through proof-of-concept trials and into advanced clinical development, and advancing its DCR-HBVS development program into proof-of-concept studies in HBV patients. This estimate assumes no new funding from additional collaboration agreements or from external financing events.
Conference Call
Management will host a conference call at 4:30 p.m. ET today to review Dicerna's first quarter 2018 financial results and provide a general business update. The conference call can be accessed by dialing (855) 453-3834 or (484) 756-4306 (international), and referencing conference ID 9666285 prior to the start of the call. The call will also be webcast via the Internet and will be available under the “Investors & Media” section of the Dicerna website, www.dicerna.com. A replay of the call will be available approximately two hours after the completion of the call and will remain available for seven days. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and refer to conference ID 9666285. The webcast will also be archived on Dicerna’s website.
About Dicerna Pharmaceuticals, Inc.
Dicerna Pharmaceuticals, Inc., is a biopharmaceutical company focused on the discovery and development of innovative, subcutaneously delivered RNAi-based therapeutics for diseases involving the liver, including rare diseases, viral infectious diseases, chronic liver diseases, and cardiovascular diseases. Dicerna is leveraging its proprietary GalXC™ RNAi technology platform to build a broad pipeline in these core therapeutic areas, focusing on target genes where connections between target gene and diseases are well understood and documented. Dicerna intends to discover, develop and commercialize novel therapeutics either on its own or in collaboration with pharmaceutical partners. For more information, please visit www.dicerna.com.
About GalXCTM RNAi Technology Platform
GalXCTM is a proprietary technology platform invented by Dicerna to discover and develop RNAi-based therapies designed to silence disease-driving genes in the liver. Compounds produced via GalXC are intended to be broadly applicable across multiple therapeutic areas, including rare diseases, viral infectious diseases, chronic liver diseases, and cardiovascular diseases. Using GalXC, Dicerna scientists attach N-acetylgalactosamine sugars directly to the extended region of the Company’s proprietary RNAi molecules, yielding multiple proprietary conjugate delivery configurations. Many of the conjugates produced via GalXC incorporate a folded motif known as a tetraloop in the extended region. The tetraloop configuration, which is unique to Dicerna’s GalXC compounds, allows flexible and efficient conjugation to the targeting ligands, and stabilizes the RNAi duplex which the Company believes will enable subcutaneous delivery of its RNAi therapies to hepatocytes in the liver, where they are designed to specifically bind to receptors on target cells, potentially leading to internalization and access to the RNAi machinery within the cells. The technology may offer several distinct benefits, as suggested by strong preclinical data. These benefits seen in preclinical studies include: potency that is on par with or better than comparable platforms; highly specific binding to gene targets; long duration of action; and an infrequent subcutaneous dosing regimen.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements, including, for example, Dicerna’s expected timeline and plans for development of DCR-PHXC and other pipeline programs, expectations related to the collaboration with BI, and guidance related to the anticipated duration and usage of current cash and cash equivalents. 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. Applicable risks and uncertainties include risks relating to Dicerna’s clinical and preclinical research and other risks identified under the heading "Risk Factors" included in the Company’s most recent Form 10-Q filing and in other future filings with the SEC. The forward-looking statements contained in this press release reflect Dicerna's current views with respect to future events, and Dicerna does not undertake and specifically disclaims any obligation to update any forward-looking statements.
Dicerna Pharmaceuticals, Inc. Consolidated Balance Sheet Information (In thousands) March 31, December 31, 2018 2017 Cash and cash equivalents $ 43,046 $ 68,789 Held-to-maturity investments $ 54,770 $ 44,889 Total assets $ 104,074 $ 121,002 Total liabilities $ 16,188 $ 19,916 Total stockholders’ equity $ 87,886 $ 101,086 Dicerna Pharmaceuticals, Inc. Consolidated Statements of Operations Information (In thousands, except share and per share data)For the Three Months Ended March 31,
2018 2017 Revenue $ 1,545 - Operating expenses: Research and development 9,893 8,743 General and administrative 7,519 5,496 Total operating expenses 17,412 14,239 Loss from operations (15,867) (14,239) Interest income 288 38 Net loss $ (15,579) $ (14,201) Net loss per share - basic and diluted $ (0.30) $ (0.68) Weighted average shares outstanding - basic and diluted 51,723,349 20,791,644
View source version on businesswire.com: https://www.businesswire.com/news/home/20180514006261/en/
Investors:Rx Communications GroupPaula Schwartz, 917-322-2216pschwartz@rxir.comorMedia:SmithSolveAlex Van Rees, 973-442-1555 ext. 111alex.vanrees@smithsolve.com
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