Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical stage biopharmaceutical company developing a novel therapeutic approach for the treatment of autoimmune diseases and genetically defined forms of B-cell lymphoma, today reported financial results for the quarter ended September 30, 2013 and provided a corporate update. “This has been a highly productive quarter at Idera, both clinically and operationally,” said Sudhir Agrawal, D. Phil., Chief Executive Officer of Idera Pharmaceuticals. “We continued to successfully execute against our stated goals in our autoimmune disease and B-cell lymphoma programs. We submitted an IND for our planned Phase 1/2 trial of IMO-8400 in Waldenström’s macroglobulinemia. In addition, we completed enrollment in our Phase 2 trial of IMO-8400 in patients with moderate-to-severe plaque psoriasis as planned and have expanded the trial to include a higher dose cohort. We also raised over $27 million in a public offering which has further strengthened our financial position and our ability to move forward on our objectives.” Program Updates Autoimmune Diseases Idera announced today several developments in its ongoing program in autoimmune diseases. In September 2013, Idera completed enrollment of the 32 patients initially planned in the Company’s ongoing randomized, double-blind, placebo-controlled Phase 2 trial of IMO-8400 in patients with moderate-to-severe plaque psoriasis. These 32 patients were randomized for treatment at three dose levels of IMO-8400, 0.075 mg/kg, 0.15 mg/kg and 0.3 mg/kg, and in a placebo cohort. While the dosing in the trial is ongoing, the data remain blinded. All treatments to date have been well tolerated in the trial. Based on this positive safety profile, the Company has expanded the trial to include a higher dose cohort of 0.6 mg/kg and placebo in up to 12 patients. Idera plans to consider further dose escalation based on the safety and tolerability observed in the expansion cohort. The Company expects to report top-line data from the first three dosing groups of the trial in the first quarter of 2014 and to report top-line data from the expansion cohort in the second quarter of 2014.
In addition, Idera has begun a strategic review of orphan autoimmune indications with unmet needs that it believes are suited to Toll-like receptor (TLR) antagonist therapy, and expects to identify priority indications in early 2014. The Company has also initiated Investigational New Drug (IND)-enabling studies for IMO-9200, an additional novel antagonist of TLRs 7, 8 and 9, which the Company expects would be available for clinical development in the second half of 2014.Genetically Defined Forms of B-cell Lymphoma Idera’s program in genetically defined forms of B-cell lymphoma is based on recent reports on patients carrying a specific genetic mutation 1. During the quarter, Idera completed preclinical studies of IMO-8400 in B-cell lymphoma models which carry a specific genetic mutation. Based on the scientific rationale and supporting preclinical data, the Company has submitted an IND application to the United States Food and Drug Administration (FDA) to conduct a Phase 1/2 trial of IMO-8400 in patients with Waldenström’s macroglobulinemia, in whom this mutation is highly prevalent. Pending acceptance of the submission by the FDA, the Company plans to begin enrolling patients in this trial during the first quarter of 2014. Additionally, Idera plans to submit a protocol to the FDA to conduct a Phase 1/2 trial in diffuse large B-cell lymphoma (DLBCL), in which a subset of patients carries the same mutation. Idera plans to submit the protocol to the FDA in the first quarter of 2014. The IND application for Waldenström’s macroglobulinemia draws from the existing set of clinical safety data already accumulated on IMO-8400, and includes preclinical data which support the use of a TLR 7 and 9 antagonist in B-cell lymphomas carrying this mutation. The Company plans to submit the data for presentation in an upcoming scientific meeting in 2014. References: 1 Lim, K, et al., AACR 2013, Abstract #2232; Shaffer, A, et al., Annu. Rev. Immunol. 2012. 30:565–610; Treon, S.P., et al., N Engl J Med 2012, 367:826-833; Ngo, V.N., et al., Nature 2011, 470:115-119 Recent Corporate Highlights In September 2013, the Company announced it had completed a public offering of common stock and pre-funded warrants raising gross proceeds of approximately $27.7 million. The Company expects that this additional financing will help support the continued development of its key clinical programs, providing the Company with the resources required to execute on its programs into mid-2015. These key clinical programs include the Company’s planned Phase 1/2 clinical trial of IMO-8400 in patients with Waldenström’s macroglobulinemia, planned Phase 1/2 clinical trial of IMO-8400 in patients with DLBCL and planned submission of an IND for IMO-9200.
In August 2013, Idera announced that it has entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with National Cancer Institute to evaluate the Company’s Toll-like receptor (TLR) antagonists as a potential approach to the treatment of certain genetically defined B-cell lymphomas.Financial Results The Company reported a net loss applicable to common stockholders for the three months ended September 30, 2013, of $5.0 million, or $0.11 per diluted share, compared to a net loss applicable to common stockholders of $4.8 million, or $0.17 per diluted share in the same period in 2012. Research and development expenses for the three-month period ended September 30, 2013, totaled $2.5 million compared to $3.3 million in the same period of 2012. General and Administration expenses for the three-month period ended September 30, 2013, totaled $2.2 million compared to $1.5 million in the same period of 2012. As of September 30, 2013, cash and cash equivalents totaled $38.7 million, following the completion on September 30 of a public offering, in which it sold 13,727,251 shares of common stock for a price to the public of $1.55 per share and pre-funded warrants to purchase up to 4,175,975 shares of common stock at an exercise price of $0.01 per share for a price to the public of $1.54 per warrant share. “This successful financing has greatly strengthened our cash position and we are now poised to execute on our strategic plans,” said Lou Arcudi, Chief Financial Officer. Webcast and Conference Call Idera will host a conference call today at 8:30 AM EST to discuss these third quarter 2013 results. In order to participate in the conference call, please dial 1-866-277-1184 (domestic) or 1-617-597-5360 (international) and provide the access code 66528815. The live webcast can be accessed under “Investor Events” in the Investors section of the Company’s website at www.iderapharma.com or you may use the link: http://edge.media-server.com/m/p/3469ec2y/lan/en. A replay of the call will be available at 1:30 p.m. EST on November 14, 2013 until 11:59 p.m. EST on November 20, 2013. To access the replay, please dial 1-888-286-8010 (domestic) or 1-617-801-6888 (international) and reference the access code 73861450. The archived webcast will be available for 30 days in the Investors section of Idera’s website at www.iderapharma.com. About Idera Pharmaceuticals, Inc. Idera's technology platform involves creating novel synthetic RNA- and DNA-based compounds to modulate immune responses. Idera has applied this platform to develop proprietary Toll-like receptor (TLR) antagonists as immunomodulatory drug candidates. Toll-like receptor antagonists block the over-activation of immune factors which can cause a range of pathological effects. Idera is conducting clinical development of TLR antagonists in autoimmune and inflammatory diseases, and preclinical development of their use in certain genetically defined forms of B-cell lymphoma. More information on Idera is available at iderapharma.com.
Forward Looking StatementsThis press release includes statements concerning Idera Pharmaceuticals, Inc. and its future expectations, plans and prospects that constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated by such forward-looking statements, including whether Idera’s cash resources will be sufficient to fund the Company’s continuing operations and the further development of the Company’s programs through the second quarter of 2015 , including the planned Phase 1/2 trial in Waldenström’s macroglobulinemia, the planned Phase 1/2 trial in DLBCL and planned submission of an IND for IMO-9200, and whether Idera will be able to obtain additional cash resources sufficient to fund the Company’s operations beyond that time; whether results obtained in early research, preclinical studies and clinical trials will be indicative of the results that will be generated in future preclinical and clinical studies; whether Idera’s preclinical studies and clinical trials will commence and will be completed when expected by Idera; whether products based on Idera's technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the FDA or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be successfully distributed and marketed; whether the Company will be able to enter into collaborations that will advance the development of its compounds for autoimmune disease indications; and such other important factors as are set forth under the caption "Risk Factors" in Idera's Quarterly Report on Form 10-Q for the period ended September 30, 2013, which important factors are incorporated herein by reference. Idera disclaims any intention or obligation to update any forward-looking statements.
|Idera Pharmaceuticals, Inc.|
|Condensed Statements of Operations (Unaudited)|
|(In thousands, except per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research & Development||2,510||3,278||6,835||10,595|
|General & Administrative||2,179||1,477||5,305||5,014|
|Total Operating Expenses||4,689||4,755||12,140||15,609|
|Loss from Operations||(4,682||)||(4,752||)||(12,097||)||(15,569||)|
|Decrease in Fair Value of Warrant Liability||-||109||-||106|
|Loss on Extinguishment of Preferred Stock and Preferred Stock Dividends||278||160||2,587||480|
|Net Loss Applicable to Common Stockholders||$||(5,016||)||$||(4,829||)||$||(14,723||)||$||(15,922||)|
|Basic & Diluted Net Loss Per Common Share Applicable to Common Stockholders||$||(0.11||)||$||(0.17||)||$||(0.40||)||$||(0.58||)|
|Shares Used in Computing Basic & Diluted Net Loss Per Common Share Applicable to Common Stockholders||45,720||27,640||37,203||27,639|
|Idera Pharmaceuticals, Inc.|
|Condensed Balance Sheet Data|
|September 30,||December 31,|
|Cash & Cash Equivalents||$||38,749||$||10,096|
|Redeemable Preferred Stock||-||5,921|
|Total Liabilities, Redeemable Preferred Stock & Stockholders' Equity||$||39,573||$||10,823|