Idera Pharmaceuticals, Inc. (Nasdaq:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for oncology and rare diseases, reported its financial and operational results for the fourth quarter and year ended December 31, 2014.
“2014 was a year of transformation for Idera, as we focused our company on oncology and rare diseases,” stated Vincent Milano, Chief Executive Officer ofIdera Pharmaceuticals. “During 2014, we commenced two Phase 1/2 clinical trials of IMO-8400 for the treatment of certain B-cell lymphomas in which the MYD88 L265P oncogenic mutation is present and also conducted pre-clinical studies of our Toll-like receptor, or TLR9 agonists as immune therapies for the treatment of cancer. In addition, we selected dermatomyositis and Duchenne muscular dystrophy, or DMD, as the first non-cancer rare diseases for which we plan to develop IMO-8400. We also expanded our leadership team and increased our capital resources, with the goal of delivering hope for the patients we aim to serve and creating value for our shareholders.”
“For 2015 we look forward to begin delivering clinical results commencing in the fourth quarter from our Phase 1/2 clinical trial of IMO-8400 in Waldenström’s macroglobulinemia. In addition, we are now working to rapidly advance our targeted immuno-oncology program into the clinic and also expect to commence clinical development in our rare diseases program by initiating a Phase 2 clinical trial of IMO-8400 in dermatomyositis and DMD by the end of 2015 and early 2016, respectively. We also plan to complete our Phase 1 healthy volunteer trial withIMO-9200 during the year. Finally, we are planning to conduct disease model studies and begin IND-enabling development programs in each of the first two disease indications selected for further development in our gene silencing oligonucleotide, or GSO, program in the second half of 2015.”
Our proprietary technology platforms are based on our scientific expertise and pioneering work with synthetic oligonucleotides as therapeutic agents. Using our TLR targeting technology, we design synthetic oligonucleotide-based drug candidates to act by modulating the activity of specific TLRs. In addition, using our GSO technology, we are developing GSOs to turn off the messenger RNA, or mRNA, associated with disease causing genes. We consider our GSO technology to be a third generation antisense technology that can potentially reduce the immunotoxicity and increase the potency of gene silencing oligonucleotides.
Genetically Defined Forms of B-cell Lymphoma
Our program in genetically defined forms of B-cell lymphoma is based on reports from several independent investigators and pre-clinical studies offering evidence that, in certain B-cell lymphomas, the presence of the MYD88 L265P mutation led to over-activation of TLR7 and TLR9 signaling and that blocking these TLRs accelerated tumor cell death.
- In December 2014, we announced that we opened enrollment in the third and final cohort of our dose-escalating Phase 1/2 clinical trial of IMO-8400in patients with Waldenström’s macroglobulinemia, a form of non-Hodgkin lymphoma. Opening enrollment into the third cohort of the trial followed the recommendation of an independent data review committee after its review of safety data from the second dose cohort of the trial. The trial is designed to evaluate IMO-8400‘s safety, tolerability and potential clinical activity in patients who have a history of relapse or failure to respond to one or more prior therapies. We anticipate that full data from this trial will be available in the fourth quarter of 2015.
- In December 2014, we announced that the U.S. Food and Drug Administration (FDA) had granted us orphan drug designation for IMO-8400for the treatment of Waldenström’s macroglobulinemia.
- We presented safety data from IMO-8400 at the American Society of Hematology Annual Meeting in December 2014.
- We continue to activate multiple clinical sites and are screening patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL, harboring the MYD88 L265P oncogenic mutation in a Phase 1/2 clinical trial of IMO-8400 in DLBCL. We anticipate that full data from this trial will be available in 2016.
- We announced in early 2015 our plans to advance either IMO-2125 or IMO-2055, two TLR9 agonists in our drug candidate pipeline, into clinical development with an intratumoral administration approach in combination with checkpoint inhibitors. Our plan is to submit an IND and to initiate at least two Phase 1/2 clinical trials with the first clinical trial commencing in the second half of 2015 with a goal of completing and having data available in at least one of the two trials no later than the end of 2016.
- In December 2014, we presented preclinical data demonstrating that cancer immunotherapy with intratumoral injections of IMO-2055 and ipilimumab, a checkpoint inhibitor, resulted in potent and systemic anti-tumor activity in multiple preclinical cancer models at the American Association for Cancer Research Tumor Immunology and Immunotherapy Meeting.
Rare Disease Programs
- We are planning to initiate clinical development of IMO-8400 for the treatment of rare diseases. We have selected dermatomyositis and DMD as the first rare diseases for which we plan to develop IMO-8400. We 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 with respect to dermatomyositis, the presence of auto-antibodies that can induce TLR-mediated immune responses. We anticipate commencing clinical development in these two indications by initiating a Phase 2 clinical trial in dermatomyositis by the end of 2015 and a Phase 1/2 clinical trial in DMD in early 2016.
Gene Silencing Oligonucleotides
- We are currently undertaking an analysis of priority oncology and rare disease indications for development of drug candidates from our GSO technology. Our key considerations in identifying disease indications in our GSO program include: 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 rapid development path to approval. We are planning to conduct disease model studies and begin IND-enabling development programs in each of the first two disease indications selected for further development in our GSO program in the second half of 2015.
Recent Corporate Highlights
In February 2015, we announced the closing of an underwritten public offering of common stock which generated net proceeds of approximately $80.6 million.
Fourth Quarter Results
Net loss applicable to common stockholders for the three months endedDecember 31, 2014 was $12.0 million, or $0.14 per diluted share, compared to a net loss applicable to common stockholders of $6.4 million, or $0.10 per diluted share, for the same period in 2013. There was nominal revenue recognized in each of the fourth quarters of 2014 and 2013. Research and development expenses for the three months ended December 31, 2014 totaled $8.2 millioncompared to $3.6 million for the same period in 2013. General and administrative expense for the three months ended December 31, 2014 totaled $3.7 compared to$2.4 million for the same period in 2013.
Full Year Results
Net loss applicable to common stockholders for the year ended December 31, 2014 was $39.2 million or $0.47 per diluted share, compared to net loss applicable to common stockholders of $21.1 million, or $0.48 per diluted share, for the same period in 2013. There was nominal revenue recognized during the years endedDecember 31, 2014 and 2013. Research and development expenses for the year ended December 31, 2014 totaled $27.5 million compared to $10.5 million for the same period in 2013. General and administrative expenses for the year endedDecember 31, 2014 totaled $11.3 million compared to $7.7 million for the same period in 2013.
As of December 31, 2014, our cash, cash equivalents and investments totaled$48.6 million compared to $35.6 million as of December 31, 2013.
Shares of Idera Pharmaceuticals closed yesterday at $4.45 . IDRA has a 1-year high of $6.87 and a 1-year low of $1.94. The stock’s 50-day moving average is $4.53 and it’s 200-day moving average is $3.46.
On the ratings front, Idera Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on December 17, Piper Jaffray analyst Edward Tenthoff reiterated a Buy rating on IDRA, with a price target of $7, which implies an upside of 57.3% from current levels. Separately, on December 9, Cowen’s Boris Peaker maintained a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Edward Tenthoff and Boris Peaker has a total average return of 33.2% and 41.9% respectively. Tenthoff has a success rate of 70.0% and is ranked 111 out of 3511 while Peaker has a success rate of 69.8% and is ranked 15
Idera Pharmaceuticals, Inc. is a clinical stage biotechnology company engaged in the discovery and development of novel synthetic DNA- and RNA- based drug candidates.