Idera Pharmaceuticals Reports Fourth Quarter and Year End 2015 Financial Results and Provides Corporate Update
During the fourth quarter of 2015 we:
- Presented positive clinical data from the ongoing Phase 1/2 trial of IMO-8400 in patients with Waldenstrom’s Macroglobulinemia at the 57th Annual Meeting of the
American Society of Hematology (ASH); - Initiated a Phase 2 clinical trial of IMO-8400 in patients with dermatomyositis;
- Entered into a collaboration and license agreement with GSK to identify, develop and commercialize 3rd Generation Antisense (3GA) molecules for treatment of renal diseases;
- Announced first two gene targets for internal development from 3GA platform;
- Initiated a Phase 1/2 clinical trial of intra-tumoral IMO-2125 in combination with ipilimumab in patients with metastatic melanoma;
- Presented additional pre-clinical IMO-2125 data at
AACR-NCI-EORTC International Conference ; and - Announced several key leadership appointments, including new Chief Medical Officer, Dr.
Joanna Horobin .
“2015 represented a foundational and momentum-building period for Idera,” stated
Continued Milano, “Overall, I am pleased with the progress made to date on many levels within the Idera organization, and also cognizant of the fact that we have much more work ahead of us. I am confident that if we continue to focus on the overall goal of delivering solutions to patients suffering severe unmet medical needs, we will achieve success and ultimately deliver the value our shareholders deserve.”
Research and Development Program Updates
IMO-8400 and IMO-2125 are our lead clinical development drug candidates. IMO-8400 is an oligonucleotide-based antagonist of Toll-like receptors (TLRs) 7, 8, and 9. IMO-2125 is an oligonucleotide-based agonist of TLR9. The company also announced during the fourth quarter, the first two development targets from its proprietary 3GA Technology platform: NLRP3 (NOD-like receptor family, pyrin domain containing protein 3) and DUX4 (Double Homeobox 4).
Toll-like Receptor (TLR) Agonism
Immuno-Oncology Program
Idera’s development program in immuno-oncology is based on pre-clinical studies that demonstrated through the mechanism of intra-tumoral injections of the TLR9 agonist, IMO-2125, the tumor microenvironment could be impacted in a manner which positively increases the efficacy of check-point inhibition. These studies have lead Idera into a strategic research alliance with the
In
Toll-like Receptor (TLR) Antagonism
Genetically Defined Forms of B-cell Lymphoma
Idera’s program in genetically defined forms of B-cell lymphoma is based on pre-clinical studies that have demonstrated, in certain B-cell lymphomas that the presence of the MYD88 L265P oncogenic mutation led to over-activation of TLR7 and TLR9 signaling and that blocking these TLRs with our antagonists promoted tumor cell death.
In
Idera previously announced that the
Rare Diseases
In
Third Generation Antisense Platform
Throughout 2015, the company undertook an analysis and prioritization of oncology and rare disease indications for potential development of drug candidates derived from our 3GA technology platform. The key considerations in identifying disease indications from our third generation antisense program included: strong evidence that the disease is caused by a specific protein; clear criteria to identify a target patient population; biomarkers for early assessment of clinical proof-of-concept; a targeted therapeutic mechanism for action; and unmet medical need to allow for a well-defined development path to approval and commercial opportunity. As a result of this analysis, in the fourth quarter of 2015 Idera announced the selection of NLRP3 (NOD-like receptor family, pyrin domain containing protein 3) and DUX4 (Double Homeobox 4) as initial gene targets to advance into IND-enabling activities, which will occur throughout 2016. Potential disease indications include, but are not limited to interstitial cystitis, uveitis and facioscapulohumeral muscular dystrophy (FSHD), respectively. The company is currently conducting clinical and regulatory pathway and commercial analysis activities in advance of conducting full IND-enabling studies throughout the remainder of 2016, with the plan to enter the clinic in 2017 for the first disease indication.
Also during the fourth quarter of 2015, Idera announced the first licensing agreement from the 3GA platform. The company entered into a worldwide collaboration and licensing agreement with GSK to research, develop and commercialize selected molecules from the platform for the treatment of selected undisclosed targets in renal disease. Under the terms of the agreement, Idera is eligible to receive approximately up to
Recent Corporate Highlights
During the fourth quarter of 2015, Idera announced the following additions to company leadership:
Joanna Horobin , M.B. Ch.B. as Senior Vice President, Chief Medical OfficerMark J. Cornfeld , M.D., M.P.H. as Vice President and Medical Lead, OncologyTanya Lewis , as Vice President, Regulatory Affairs and QualityJohn Kirby , as Vice President, Corporate AccountingKirsten Gruis , M.D., M.S. as Senior Medical Director, Rare Diseases
Financial Results
Fourth Quarter Results
Net loss applicable to common stockholders for the three months ended
Full Year Results
Net loss applicable to common stockholders for the year ended
As of
About
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, clinical trials, plans, and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether results obtained in preclinical studies and clinical trials such as the results described in this release will be indicative of the results that will be generated in future clinical trials; whether products based on Idera's technology will advance into or through the clinical trial process when anticipated or at all or warrant submission for regulatory approval; whether such products will receive approval from the
Idera Pharmaceuticals, Inc. | ||||||||||||||||||
Condensed Statements of Operations | ||||||||||||||||||
(In thousands, except per share data) | ||||||||||||||||||
Three Months Ended | Years Ended | |||||||||||||||||
December 31, | December 31, | |||||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||||
Alliance Revenue | $ | 190 | $ | 2 | $ | 249 | $ | 73 | ||||||||||
Operating Expenses | ||||||||||||||||||
Research & Development | 8,565 | 8,245 | 33,699 | 27,493 | ||||||||||||||
General & Administrative | 3,708 | 3,686 | 15,396 | 11,332 | ||||||||||||||
Total Operating Expenses | 12,273 | 11,931 | 49,095 | 38,825 | ||||||||||||||
Loss from Operations | (12,083 | ) | (11,929 | ) | (48,846 | ) | (38,752 | ) | ||||||||||
Other Income (Expense), Net | 93 | 11 | 291 | 110 | ||||||||||||||
Net Loss | (11,990 | ) | (11,918 | ) | (48,555 | ) | (38,642 | ) | ||||||||||
Preferred stock dividends | - | 97 | - | 519 | ||||||||||||||
Net loss applicable to common stockholders | $ | (11,990 | ) | $ | (12,015 | ) | $ | (48,555 | ) | $ | (39,161 | ) | ||||||
Basic and diluted net loss per common share applicable to common stockholders | $ | (0.10 | ) | $ | (0.14 | ) | $ | (0.42 | ) | $ | (0.47 | ) | ||||||
Shares used in computing basic and diluted net loss per common share applicable to common stockholders | 118,865 | 87,657 | 115,092 | 82,827 | ||||||||||||||
Idera Pharmaceuticals, Inc. | ||||||||||||||||||
Condensed Balance Sheet Data | ||||||||||||||||||
(In thousands) | ||||||||||||||||||
At December 31, | ||||||||||||||||||
2015 | 2014 | |||||||||||||||||
Cash, Cash Equivalents & Investments | $ | 87,157 | $ | 48,571 | ||||||||||||||
Other Assets | 5,119 | 2,855 | ||||||||||||||||
Total Assets | $ | 92,276 | $ | 51,426 | ||||||||||||||
Total Liabilities | $ | 8,694 | $ | 8,024 | ||||||||||||||
Total Stockholders' Equity | 83,582 | 43,402 | ||||||||||||||||
Total Liabilities & Stockholders' Equity | $ | 92,276 | $ | 51,426 | ||||||||||||||
Investor Contact:Robert Doody VP,IR & Corporate Communications . 617-679-5515 (office) 484-639-7235 (mobile) rdoody@iderapharma.com