-Management to Host Conference Call Today at
"During Q2, Dicerna took the exciting step of launching a Phase 1
clinical trial with DCR-MYC for patients with solid tumors and
hematological malignancies," stated
Oncology Program Updates
DCR-MYC is a potent and specific inhibitor of MYC, an oncogene that is frequently amplified or otherwise upregulated in a wide variety of cancer tumor types, including hepatocellular carcinoma (HCC). The MYC oncogene encodes for a small intracellular protein that lacks a good binding site, making it a challenging target for monoclonal antibody therapies or traditional small molecules. Historically, this challenge has led to MYC being deemed an undruggable target. However, DsiRNA-based therapeutics may be able to overcome these challenges - Dicerna has shown that DCR-MYC knocked down gene transcript activity and reduced tumor volume in multiple mouse tumor models, involving a variety of tumor types.
Phase 1 DCR-MYC Trials in Solid Tumors and Hepatocellular Carcinoma (HCC)
Rare Disease Program Update
DCR-PH1 is a therapeutic candidate for Primary Hyperoxaluria 1 (PH1), a rare, inherited autosomal recessive disorder of metabolism in the liver that usually results in life-threatening damage to the kidneys. In the genetic mouse model of PH1, Dicerna has shown that DCR-PH1 inactivates the gene encoding glycolate oxidase, significantly reducing the production of oxalate, the key disease pathology of PH1.
More detailed financial information and analysis may be found in the
Company's Quarterly Report on Form 10-Q, which was filed with the
Based on our current cash position and operating plan, the Company re-iterates its expectation that it has sufficient cash to fund operations through 2016. This estimate assumes no additional funding from new partnership agreements or debt or equity financing events.
Management will conduct a conference call at
Dicerna is a biopharmaceutical company focused on the discovery and development of innovative treatments for rare, inherited diseases involving the liver and for cancers that are genetically defined. The Company is using its proprietary RNA interference (RNAi) technology platform to build a broad pipeline in these therapeutic areas. In both rare diseases and oncology, Dicerna is pursuing targets that have historically been difficult to inhibit using conventional approaches, but where connections between targets and diseases are well understood and documented. The Company 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.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements, including
statements regarding Dicerna's clinical development. Such
forward-looking statements are subject to risks and uncertainties,
including financial, scientific, and regulatory risks regarding clinical
development that could cause actual results to differ materially from
those expressed or implied in such statements. Applicable risks and
uncertainties include those identified under the heading "Risk Factors"
included in the Form 10-Q filed
|Consolidated Balance Sheets (unaudited)|
|Cash and cash equivalents||$||77,732||$||46,595|
|Long-term debt, including current portion||$||-||$||4,847|
|Total stockholders' equity (deficit)||$||120,195||$||(68,919||)|
|Consolidated Statements of Operations (unaudited)|
|(In thousands, except share and per share data)|
For the Three Months Ended
For the Six Months Ended
|Research and development||$||6,806||$||2,513||$||12,057||$||4,931|
|General and administrative||4,372||1,142||7,213||2,278|
|Total operating expenses||11,178||3,655||19,270||7,209|
|Loss from operations||(11,178||)||(3,655||)||(19,270||)||(7,209||)|
|Preferred stock warrant remeasurement||-||118||(2,559||)||123|
|Other income (expense), net||(177||)||(249||)||(330||)||(519||)|
Less: Accretion and dividends on
Net loss attributable to common stockholders
Net loss per share allocable to
Weighted average shares outstanding
|GAAP to Non-GAAP Reconciliation: Net Loss and Net Loss Per Share|
|(unaudited, in thousands, except per share amounts)|
Three Months Ended
Six Months Ended
|NET LOSS PER SHARE|
GAAP net loss per share attributable to common stockholders - basic and diluted
|Adjustments to net loss (as detailed below||$||0.13||$||33.13||$||0.52||$||70.30|
|Non-GAAP loss per share - basic and diluted||$||(0.51||)||$||(138.00||)||$||(1.05||)||$||(273.62||)|
|An itemized reconciliation between net loss on a GAAP basis and net loss on a non-GAAP basis is as follows:|
|GAAP net loss attributable to common stockholders||$||(11,355||)||$||(4,808||)||$||(22,363||)||$||(9,638||)|
|Accretion and dividends on redeemable convertible preferred stock||$||-||$||1,022||$||204||$||2,033|
|Preferred stock warrant remeasurement||$||-||$||(118||)||$||2,559||$||(123||)|
|R&D: Stock-based compensation||$||886||$||1||$||2,612||$||6|
|G&A: Stock-based compensation||$||1,519||$||26||$||2,005||$||54|
|Non-GAAP net loss||$||(8,950||)||$||(3,877||)||$||(14,983||)||$||(7,668||)|
|Weighted Average Shares Outstanding - basic and diluted||17,684,563||28,095||14,272,401||28,024|
|Numbers may not foot due to rounding|
Use of Non-GAAP Financial Measures
We supplement our consolidated financial statements presented on a GAAP
basis by providing additional measures which may be considered
"non-GAAP" financial measures under applicable
These non-GAAP financial measures are not in accordance with generally
accepted accounting principles in
1. Stock-based compensation expense recorded in accordance with the accounting standard for share-based payments.
We believe that excluding the accounting impact of share-based payments, for both employees and non-employees, better reflects the recurring economic characteristics of our business. Share-based payments to non-employees are measured at each reporting date and recognized as services are rendered or vesting occurs.
2. Warrant remeasurement in accordance with accounting standards for derivative instruments.
We believe that excluding preferred stock warrant remeasurement better reflects the recurring economics of our business. Upon our IPO, the warrants were reclassified to additional paid-in capital and are no longer marked to market.
3. Other items.
We evaluate other items on an individual basis, and consider both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to our ongoing business operations, and (iii) whether or not we expect it to occur as part of our normal business on a regular basis.
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