| Item 2.02. | Results of Operations and Financial Condition |
The information contained in Exhibit 99.1 and described in Item 7.01 of this Form 8-K, as it relates to the cash balance of Dicerna Pharmaceuticals, Inc. (the “Company”) for the year ended December 31, 2020, is incorporated herein by reference.
| Item 7.01. | Regulation FD Disclosure |
Corporate Presentation
The Company from time to time presents or distributes to the investment community at various industry and other conferences slide presentations to provide updates and summaries of its business. The Company is posting to the “Investors” portion of its website at http://investors.dicerna.com/ a copy of its current corporate slide presentation. These slides are attached to this Current Report on Form 8-K as Exhibit 99.1. The Company undertakes no obligation to update, supplement, or amend the materials attached hereto as Exhibit 99.1.
Belcesiran Candidate
The Company updated its disclosure related to its alpha-1 antitrypsin deficiency-associated liver disease (“AATLD”) development program. Based on an assessment of data and other considerations related to the Company’s belcesiran (formerly DCR-A1AT) candidate and Alnylam’s ALN-AAT02 candidate, both investigational therapies in development for the treatment of AATLD, the Company selected belcesiran for clinical advancement, with an expected first half 2021 Phase 2 clinical trial initiation.
The information in Items 2.02 and 7.01 of this Form 8-K, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Cautionary Note on Forward-Looking Statements
This Current Report on Form 8-K has been prepared by Dicerna Pharmaceuticals, Inc. (“we,” “us,” “our,” “Dicerna,” or the “Company”) and includes forward-looking statements. 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: (i) the therapeutic and commercial potential of nedosiran, RG6346 (RO7445482), belcesiran (formerly known as DCR-A1AT) and the GalXC™ platform; (ii) expectations about our cash, cash equivalents, and marketable securities; (iii) research and development plans and timelines, as well as regulatory pathways and plans, related to nedosiran, RG6346, belcesiran, and GalXC; (iv) the potential of Dicerna’s technology and drug candidates in the Company’s research and development pipeline, including our pipeline expansion efforts and expectations; (v) the Company’s collaborations with Novo Nordisk A/S; Roche; Eli Lilly and Company; Alexion Pharmaceuticals, Inc.; Boehringer Ingelheim International GmbH; and Alnylam Pharmaceuticals, Inc.; and (vi) the Company’s strategy, business plans, and focus. The process by which an early-stage investigational therapy such as nedosiran and an early-stage platform such as GalXC could potentially lead to an approved product is long and subject to significant risks. Applicable risks and uncertainties include, but are not limited to, those risks identified under the heading “Risk Factors” included in the Company’s most recent Form 10-K filing and in other subsequent filings with the Securities and Exchange Commission. These risks and uncertainties include, among others, the impact to, and potential for delays in, the current and future conduct of the business of the Company, its clinical programs and operations as a result of the COVID-19 pandemic; the cost, timing, and results of preclinical studies and clinical trials and other development activities; the likelihood of Dicerna’s clinical programs being executed within timelines provided and reliance on the Company’s contract research organizations and predictability of timely enrollment of subjects and patients to advance Dicerna’s clinical trials; the potential for future data to alter initial, interim, and preliminary results of clinical trials, including the multidose data from the PHYOX™3 trial of nedosiran; the unpredictability of the duration and results of the regulatory review of Investigational New Drug (“IND”) applications and Clinical Trial Applications that are necessary to continue to advance and progress the Company’s clinical programs and the regulatory review of submissions relevant to regulatory agencies for marketing approvals, including New Drug Applications (“NDAs”); market acceptance for approved products and innovative therapeutic treatments; competition; the possible impairment of, inability to obtain and costs of obtaining needed intellectual property rights; possible safety or efficacy concerns that could emerge as new data are generated in R&D; that the Company may not realize the intended benefits of its collaborations; general business, financial and accounting risks; and the risks and potential outcomes from litigation. Dicerna is providing this information as of this date and does not undertake any obligation to update or revise it, whether as a result of new information, future events, or circumstances or otherwise. Additional information concerning Dicerna and its business may be available in press releases or other public announcements and public filings made after the date of this information.
