Idera Pharmaceuticals Reports First Quarter 2016 Financial Results and Provides Corporate Update
9 of 10 Waldenstrom’s Macroglobulinemia Patients Treated at the Highest Dose have Demonstrated Reductions in IgM or M-Protein Levels in Ongoing Trial
Company is on Track to Deliver Data from 4 Clinical Trials over Next 6 to 18 Months
“Idera continued to make strong progress across all of our areas of focus during the first period of 2016,” stated
Continued Milano, “The amount of strategic consideration and effort that has taken place over the past year and the related execution should provide us with critical catalysts beginning in the second half of this year and right through the course of 2017 across all aspects of our business. We’re currently conducting four separate clinical trials and we expect data from all four of these studies over the course of the next six to 18 months. This is an exciting time for Idera and we look forward to a very bright future for the patients we aim to serve as well as our investors, who support these bold endeavors.”
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 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 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 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 led Idera into a strategic research alliance with the
In
Additionally, the company presented new preclinical data demonstrating the potentiation of anti-tumor effects through combination of IMO-2125 and indoleamine-pyrolle 2,3-dioxygenase (IDO-1) in cancer models at the
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 driven by the oncogenic MYD88-L265P mutation, blocking TLR7 and 9 signaling can promote tumor cell death.
In
Idera previously announced that the
Rare Diseases
In
The company announced during the first quarter of 2016 that due to the resources required to fully commit to a Duchenne muscular dystrophy (DMD) clinical development endeavor, the company has chosen to suspend internal efforts at this time to advance IMO-8400 into clinical development for DMD.
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 and conducting IND-enabling studies with the plan to enter the clinic in 2017 for the first disease indication.
Financial Results
First Quarter 2016 Results
Net loss for the three months ended
As of
Investor Event and Webcast
Idera will host a conference call and live webcast on
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 - Unaudited | ||||||||
(In thousands, except per share data) | ||||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2016 | 2015 | |||||||
Alliance Revenue | $ | 294 | $ | 34 | ||||
Operating Expenses | ||||||||
Research & Development | 9,296 | 8,720 | ||||||
General & Administrative | 3,916 | 3,837 | ||||||
Total Operating Expenses | 13,212 | 12,557 | ||||||
Loss from Operations | (12,918 | ) | (12,523 | ) | ||||
Other Income (Expense), Net | 95 | 42 | ||||||
Net loss applicable to common stockholders | $ | (12,823 | ) | $ | (12,481 | ) | ||
Basic and diluted net loss per common share applicable to common stockholders | $ | (0.11 | ) | $ | (0.12 | ) | ||
Shares used in computing basic and diluted net loss per common share applicable to common stockholders | 121,284 | 105,067 | ||||||
Idera Pharmaceuticals, Inc. | ||||||||
Condensed Balance Sheet Data | ||||||||
(In thousands) | ||||||||
At March 31, | At December 31, | |||||||
2016 | 2015 | |||||||
(Unaudited) | ||||||||
Cash, Cash Equivalents & Investments | $ | 74,122 | $ | 87,157 | ||||
Other Assets | 5,198 | 5,119 | ||||||
Total Assets | $ | 79,320 | $ | 92,276 | ||||
Total Liabilities | $ | 6,642 | $ | 8,694 | ||||
Total Stockholders' Equity | 72,678 | 83,582 | ||||||
Total Liabilities & Stockholders' Equity | $ | 79,320 | $ | 92,276 | ||||
Investor Contact:Robert Doody VP,IR & Corporate Communications . 617-679-5515 (office) 484-639-7235 (mobile) rdoody@iderapharma.com