CAMBRIDGE, Mass. and EXTON, Pa., March 12, 2015 (GLOBE NEWSWIRE) -- 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, today 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 of Idera 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 with IMO-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-8400 in 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-8400 for 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 ended December 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 million compared 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 ended December 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 ended December 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.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic approach for the treatment of genetically defined forms of B-cell lymphoma and rare diseases. Idera's proprietary technology involves using a TLR) targeting technology, to design synthetic oligonucleotide-based drug candidates to act by modulating the activity of specific TLRs. In addition to its TLR programs, Idera is developing gene silencing oligonucleotides (GSOs) that it has created using its proprietary technology to inhibit the production of disease-associated proteins by targeting RNA.
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, 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 U.S. Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be successfully distributed and marketed; whether the Company's collaborations will be successful; and such other important factors as are set forth under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2014. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
|Idera Pharmaceuticals, Inc.|
|Condensed Statements of Operations|
|(In thousands, except per share data)|
|Three Months Ended||Years Ended|
|December 31,||December 31,|
|Alliance Revenue||$ 2||$ 4||$ 73||$ 47|
|Research & Development||8,245||3,640||27,493||10,475|
|General & Administrative||3,686||2,436||11,332||7,741|
|Total Operating Expenses||11,931||6,076||38,825||18,216|
|Loss from Operations||(11,929)||(6,072)||(38,752)||(18,169)|
|Other Income (Expense), Net||11||(18)||110||(57)|
|Loss on extinguishment of convertible preferred stock, preferred stock accretion and dividends||97||279||519||2,866|
|Net loss applicable to common stockholders||$ (12,015)||$ (6,369)||$ (39,161)||$ (21,092)|
|Basic and diluted net loss per common share applicable to common stockholders||$ (0.14)||$ (0.10)||$ (0.47)||$ (0.48)|
|Shares used in computing basic and diluted net loss per common share applicable to common stockholders||87,657||63,795||82,827||43,906|
|Idera Pharmaceuticals, Inc.|
|Condensed Balance Sheet Data|
|At December 31,|
|Cash, Cash Equivalents & Investments||$ 48,571||$ 35,592|
|Total Assets||$ 51,426||$ 36,867|
|Total Liabilities||$ 8,024||$ 4,415|
|Total Stockholders' Equity||43,402||32,452|
|Total Liabilities & Stockholders' Equity||$ 51,426||$ 36,867|
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