Idera Pharmaceuticals Inc (NASDAQ:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel nucleic acid-based therapeutics for oncology and rare diseases, today reported its financial and operational results for the third quarter ended September 30, 2015.
“We’ve made a great deal of progress at Idera through the first three quarters of 2015, which sets up our company for a number of important catalysts in this last quarter of the year,” stated Vincent Milano, Idera’s Chief Executive Officer. “As we announced yesterday, we will be presenting the clinical and safety data analysis from our Phase 1/2 clinical trial of IMO-8400 in Waldenström’s macroglobulinemia at the American Society of Hematology Annual Meeting in December. We also are initiating our clinical studies of our TLR9 agonist, IMO-2125 in combination with ipilmumab in patients with metastatic melanoma andIMO-8400 Phase 2 study in dermatomyositis, this quarter. Finally, as detailed in the following text, we are today announcing the first two gene targets for our third generation antisense technology platform.”
Continued Milano, “I’m very pleased with the progress that our team at Idera has made over the past months and quarters as we’ve integrated the existing Idera team with many new contributors all the while maintaining the rigor and momentum to ensure our company is positioned for both near and long-term success.”
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.
Toll-like Receptor (TLR) Agonism Program
In June 2015, the company announced that it had entered into a strategic clinical research alliance with MD Anderson Cancer Center to advance the clinical development of intra-tumoral TLR9 agonists in combination with checkpoint inhibitors. The company also announced that it expects to initiate the first trial from the alliance, a Phase 1/2 study to assess the safety and efficacy of intra-tumoral IMO-2125 in combination with ipilimumab in approximately 45 patients with metastatic melanoma. The company is on track to initiate this study in the fourth quarter of 2015. Planning of additional studies as part of the clinical research alliance with MD Anderson Cancer Center is in progress. Additionally, the company presented new preclinical data demonstrating the combination of IMO-2125 and PD1 in cancer models at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on November 5th inBoston, MA.
Toll-like Receptor (TLR) Antagonism Programs
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 the company’s Phase 1/2 study in Waldenstrom’s macroglobulinemia, the targeted number of patients at each of the three dose levels completed assessment through the end of their first cycle of treatment; the dose escalation portion of the study has also been completed. The trial is designed to evaluateIMO-8400’s safety, tolerability and potential clinical activity in patients who have a history of relapse after or failure to respond to prior therapies. Idera announced yesterday that data from this Phase 1/2 clinical study will be presented as a poster at the American Society of Hematology (ASH) Annual Meeting onSaturday, December 5th from 5:30 PM ET – 7:30 PM ET.
During the third quarter the company also continued to enroll patients into the first of three dose cohorts of our Phase 1/2 clinical trial of IMO-8400 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are harboring the MYD88 L265P oncogenic mutation. The company currently anticipates that data from this trial will become available in 2016.
Idera previously announced that the U.S. Food and Drug Administration (FDA) granted us orphan drug designation for IMO-8400 for the treatment of Waldenström’s macroglobulinemia and DLBCL.
Rare Disease Programs
The company is planning to initiate clinical development of IMO-8400 for the treatment of rare autoimmune and autoinflammatory diseases. The company has selected dermatomyositis and Duchenne muscular dystrophy (DMD) as the first rare diseases for which we plan to develop IMO-8400. The company selected these indications for development based on the reported increase in TLR expression in these disease states, expression of cytokines indicative of key TLR-mediated pathways, the identification of prospective biomarkers for evaluation in early clinical trials and significant unmet needs. The company plans to progress clinical development in these two indications by initiating a Phase 2 clinical trial in dermatomyositis in the fourth quarter of 2015 and a Phase 2 clinical trial in DMD in 2016.
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 third generation antisense 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, the company has selected NLRP3 (NOD-like receptor family, pyrin domain containing protein 3) and DUX4 (Double Homeobox 4) as 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 intends to describe these programs in more detail during the 2016 JP Morgan Healthcare Conference early next year.
Third Quarter 2015 Results
Net loss applicable to common stockholders for the three months endedSeptember 30, 2015 was $11.4 million, or $ (0.10) per diluted share, compared to a net loss applicable to common stockholders of $9.6 million, or $ (0.11) per diluted share, for the same period in 2014. For the nine month period endedSeptember 30, 2015, the Company’s net loss applicable to common stockholders was $36.6 million, or $ (0.32) per diluted share, compared to a net loss applicable to common stockholders of $27.1 million, or $ (0.33) per diluted share, for the same period in 2014. The company recognized nominal revenue in the third quarter and nine month periods of 2015 and 2014.
Research and development expenses for the three months ended September 30, 2015 totaled $7.5 million compared to $6.7 million for the same period in 2014. For the nine month period ended September 30, 2015, research and development expenses totaled $25.1 million compared to $19.2 million for the same period in 2014.
General and administrative expenses for the three months ended September 30, 2015 totaled $4.0 million compared to $2.9 million for the same period in 2014. For the nine month period ended September 30, 2015, general and administrative expenses totaled $11.7 million compared to $7.6 million for the same period in 2014.
As of September 30, 2015, Idera’s cash, cash equivalents and investments totaled $94.7 million compared to $48.6 million as of December 31, 2014. (Original Source)
Shares of Idera Pharmaceuticals closed yesterday at $3.18. IDRA has a 1-year high of $5.48 and a 1-year low of $2.27. The stock’s 50-day moving average is $3.15 and its 200-day moving average is $3.23.
Idera Pharmaceuticals Inc is a clinical stage biotechnology company. The Company is engaged in the discovery, development and commercialization of novel therapeutics for oncology and rare diseases.