Idera Pharmaceuticals Reports Second Quarter 2016 Financial Results and Provides Corporate Update
“The second quarter of this year represented a period of solid execution throughout the organization,” stated
Continued Milano, “I’m very proud of the team’s focus and determination as they continued to advance our research and development programs. We certainly have much more work ahead of us to arrive at our ultimate goal of delivering solutions to patients; however, we are energized knowing that we will soon be in possession of critical information to further understand the potential of these opportunities.”
Research and Development Program Updates
IMO-2125 and IMO-8400 are the Company’s lead clinical development drug candidates. IMO-2125 is an oligonucleotide-based agonist of Toll-like receptor (TLR) 9. IMO-8400 is an oligonucleotide-based antagonist of TLRs 7, 8, and 9. The Company also announced during the fourth quarter of 2015, 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). The Company continues to evaluate these and other potential targets for clinical proof of concept. The Company plans to take the first 3GA candidate into human proof of concept studies in 2017.
Toll-like Receptor (TLR) Agonism
Immuno-Oncology Program
Idera’s development program in immuno-oncology is based on the rationale that intra-tumoral injections of IMO-2125, a TLR9 agonist, will activate dendritic cells and modulate the tumor microenvironment to potentiate the anti-tumor activity of checkpoint inhibitors. This rationale is supported by pre-clinical data in multiple tumor types. These studies have led Idera into a strategic alliance with the
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The study has recently been amended to include the exploration of the combination of IMO-2125 with pembrolizumab, an anti-PD1 antibody.
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 that, in certain B-cell lymphomas driven by the oncogenic MYD88-L265P mutation, blocking TLR7 and 9 signaling can promote tumor cell death.
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Idera previously announced that the
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Third Generation Antisense Platform (3GA)
Idera’s proprietary third-generation antisense (3GA) platform technology is focused on silencing the mRNA associated with disease causing genes. Idera has designed 3GA oligonucleotides to overcome specific challenges associated with earlier generation antisense technologies and RNAi technologies.
In late 2015, Idera announced the identification 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 related to these targets include, but are not limited to, interstitial cystitis, lupus nephritis, uveitis and facioscapulohumeral muscular dystrophy (FSHD). The Company is currently conducting clinical, regulatory and commercial analysis activities and conducting IND-enabling studies with the plan to enter the clinic in 2017 for the first clinical development program. In addition to these activities, over the first half of 2016, Idera generated 3GA compounds for a series of additional gene targets. These will enable the Company to continue to expand its future pipeline opportunities for both internal development as well as partnerships in areas outside of Idera’s focus. Idera plans to present pre-clinical data at several conferences in the second half of 2016.
In late 2015, Idera entered into a collaboration and license agreement with GSK to research, develop and commercialize compounds from its 3GA technology for the treatment of undisclosed, selected renal targets. As per the terms of the agreement, Idera received an upfront payment of
Financial Results
Second Quarter 2016 Results
Net loss for the three months ended
Research and development expenses for the three months ended
General and administrative expense for the three months 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 pre-clinical 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 - Unaudited (In thousands, except per share data) |
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Three Months Ended | Six Months Ended | ||||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||||||
Alliance Revenue | $ | 301 | $ | 5 | $ | 595 | $ | 39 | |||||||||||||
Operating Expenses | |||||||||||||||||||||
Research & Development | 10,128 | 8,960 | 19,424 | 17,680 | |||||||||||||||||
General & Administrative | 3,778 | 3,821 | 7,694 | 7,658 | |||||||||||||||||
Total Operating Expenses | 13,906 | 12,781 | 27,118 | 25,338 | |||||||||||||||||
Loss from Operations | (13,605 | ) | (12,776 | ) | (26,523 | ) | (25,299 | ) | |||||||||||||
Other Income (Expense), Net | 120 | 57 | 215 | 99 | |||||||||||||||||
Net Loss | $ | (13,485 | ) | $ | (12,719 | ) | $ | (26,308 | ) | $ | (25,200 | ) | |||||||||
Basic and diluted net loss per common share applicable to common stockholders | $ | (0.11 | ) | $ | (0.11 | ) | $ | (0.22 | ) | $ | (0.23 | ) | |||||||||
Shares used in computing basic and diluted net loss per common share applicable to common stockholders | 121,323 | 118,002 | 121,304 | 111,570 | |||||||||||||||||
Idera Pharmaceuticals, Inc. Condensed Balance Sheet Data (In thousands) |
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At June 30, | At December 31, | ||||||||||||||||||||
2016 | 2015 | ||||||||||||||||||||
(Unaudited) | |||||||||||||||||||||
Cash, Cash Equivalents & Investments | $ | 64,096 | $ | 87,157 | |||||||||||||||||
Other Assets | 5,141 | 5,119 | |||||||||||||||||||
Total Assets | $ | 69,237 | $ | 92,276 | |||||||||||||||||
Total Liabilities | $ | 8,188 | $ | 8,694 | |||||||||||||||||
Total Stockholders' Equity | 61,049 | 83,582 | |||||||||||||||||||
Total Liabilities & Stockholders' Equity | $ | 69,237 | $ | 92,276 | |||||||||||||||||
Investor Contact:Robert Doody VP,IR & Corporate Communications . 617-679-5515 (office) 484-639-7235 (mobile) rdoody@iderapharma.com