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TMCNet:  Idera Pharmaceuticals Reports First Quarter 2014 Financial Results and Provides Update on Key Programs and Business Strategy

[May 13, 2014]

Idera Pharmaceuticals Reports First Quarter 2014 Financial Results and Provides Update on Key Programs and Business Strategy

CAMBRIDGE, Mass. --(Business Wire)--

Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical stage biopharmaceutical company developing novel nucleic acid therapeutics for orphan diseases, today reported its financial and operational results for the quarter ended March 31, 2014. The Company's clinical focus has now evolved to center on patients with genetically defined forms of B-cell lymphoma and on patients with rare autoimmune diseases.

"We believe we have made tremendous progress in 2014 based on the foundation we built in 2013. During this year, we initiated clinical development of IMO-8400 in Waldenström's macroglobulinemia and in diffuse large B-cell lymphoma (DLBCL) patients harboring the MYD88 L265P mutation. We look forward to progressing IMO-8400 in clinical trials for these indications," said Sudhir Agrawal, D. Phil., Chief Executive Officer of Idera Pharmaceuticals. "In addition, our strategic assessment of orphan autoimmune diseases has led us to identify graft-versus-host disease (GvHD), polymyositis, and dermatomyositis as the initial prioritized disease indications for clinical development of our TLR antagonist candidates."

Dr. Agrawal continued, "To support the clinical development of our pipeline of candidates and technology platforms, we strengthened the management team in key areas with the addition of Lou Brenner, M.D., as Senior Vice President and Chief Medical Officer; Kate Haviland as Vice President Rare Diseases; Joe Lobacki as General Manager of Oncology; Walter Strapps, Ph.D., as Executive Director of RNA Therapeutics; and Nancy Wyant as Vice President of Clinical Operations. Our new team members bring extensive biopharmaceutical industry expertise and the skills which would enable us to advance our pipeline to commercialization. We are very pleased to have them on board."

Recent Corporate Updates

Program for Genetically Defined Forms of B-cell Lymphoma

Idera's program in genetically defined forms of B-cell lymphoma is directed to patients harboring the MYD88 L265P oncogenic mutation. Clinical development has been initiated.

  • A Phase 1/2 clinical trial of IMO-8400 in patients with Waldenström's macroglobulinemia, who have relapsed or were refractory to prior therapy, is ongoing. This trial is designed to evaluate safety, tolerability and clinical activity of escalating IMO-8400 dose levels. The Company anticipates enrolling up to approximately 30 patients in this trial.
  • Idera is preparing to conduct a Phase 1/2 clinical trial of IM0-8400 in patients with DLBCL who harbor the MYD88 L265P mutation and have relapsed or were refractory to prior therapy. This trial is designed to evaluate safety, tolerability and clinical activity of escalating IMO-8400 dose levels. The Company anticipates enrolling up to approximately 30 patients in this trial and expects to initiate patient treatment in the second half of 2014.
  • In April 2014, Idera presented preclinical data at the American Association of Cancer Research (AACR) Annual Meeting demonstrating the ability of IMO-8400 to inhibit tumor growth and survival signaling in human B-cell lymphoma cells harboring the MYD88 L265P oncogenic mutation.
  • In May 2014, Idera entered into an agreement with Abbott, Inc., a leader in companion diagnostics, for the development of an in vitro companion diagnostic test in support of Idera's clinical development program to treat certain genetically defined forms of B-cell lymphoma with IMO-8400.

Program in Orphan Autoimmune Diseases

  • In March 2014, Idera announced its plans to initiate clinical development of IMO-8400 to treat patients with polymyositis and dermatomyositis. In addition to myositis, GvHD has also been prioritized for development, in continuation of a previously announced strategy of orphan autoimmune diseases. The Company anticipates initiating treatment in clinical trials for each of these patient populations during the second half of 2014.
  • In March 2014, the Company announced positive top-line data from a randomized, double-blind, placebo controlled Phase 2 trial of IMO-8400 in 32 patients with moderate-to-severe plaque psoriasis. The trial met the primary objective of demonstrating safety and tolerability, as well as a secondary objective of clinical activity of IMO-8400. The Company intends to submit the full data set, including data from an additional higher dose cohort, for presentation at a medical meeting in 2014.
  • Idera has selected IMO-9200, a second novel antagonist of TLR7, TLR8, and TLR9, as an additional drug candidate for development. The Company expects to initiate a Phase 1 clinical trial of IMO-9200 in the second half of 2014.

Gene Silencing Oligonucleotide (GSO) Platform

Idera's gene silencing oligonucleotide (GSO) platform represents an optimized third generation antisense technology. In preclinical studies to date, the Company's GSOs have shown favorable characteristics and a potentially improved therapeutic index relative to other antisense technologies. Idera plans to initiate clinical proof-of-concept studies for two disease indications as early as the second half of 2015.

Leadership Team Additions

Idera has appointed Nancy Wyant as Vice President of Clinical Operations. Nancy joins Idera with over 18 years of extensive experience in clinical trial development and management. She most recently worked at Sarepta Therapeutics, where she served as Senior Director and Head of Clinical Operations. Prior to that, she held roles of increasing responsibility in clinical operations at Shire Human Genetic Therapies.

In addition, during 2014, Idera welcomed the following new members to its management team:

  • Lou Brenner, M.D., Senior Vice President and Chief Medical Officer
  • Kathryn Haviland, Vice President Rare Diseases
  • Joseph Lobacki, General Manager of Oncology
  • Walter Strapps, Ph.D., Executive Director of RNA Therapeutics

During the first quarter of 2014, Idera also appointed the following new members to its Board of Directors:

  • Mark Goldberg, M.D., currently Executive Vice President for Medical and Regulatory Affairs at Synageva BioPharma Corp
  • Julian C. Baker, Co-Managing Member of Baker Bros. Advisors LP
  • Kelvin M. Neu, M.D., Managing Director of Baker Bros. Advisors LP

First Quarter 2014 Financial Results

Net loss applicable to common stockholders for the three months ended March 31, 2014 was $9.1 million, or $0.12 per diluted share, compared to a net loss applicable to common stockholders of $4.1 million, or $0.15 per diluted share, for the same period in 2013. There was nominal revenue recognized in the first quarter of 2014 and 2013.

Research and development expense for the three months ended March 31, 2014 totaled $6.9 million compared to $2.3 million for the same period in 2013.

General and administrative expense for the three months ended March 31, 2014 totaled $2.0 million compared to $1.5 million for the same period in 2013.

As of March 31, 2014, Idera's cash, cash equivalents and investments totaled $70.6 million compared to $35.6 million as of December 31, 2013.

In February 2014, Idera announced the closing of its underwritten public offering, with gross proceeds of approximately $40.1 million.

"We ended the first quarter of 2014 in a strong financial position," said Lou Arcudi, Chief Financial Officer of Idera Pharmaceuticals. "With the $40.1 million in gross proceeds raised recently in an underwritten public offering, we believe we have the resources necessary to advance our clinical and preclinical programs in both our TLR antagonist and GSO technology platforms, and reach our near term business objectives."

Webcast and Conference Call

Idera will host a conference call today at 8:00 a.m. EDT to discuss first quarter 2014 financial results and provide a detailed review of its pipeline progress, business strategy, recent highlights and upcoming milestones.

In order to participate in the conference call, please dial 1-800-706-7741 (domestic) or 1-617-614-3471 (international) and provide the access code 15389137. The live webcast and slides 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://www.media-server.com/m/p/rpot3zjr.

A replay of the call will be available at 1:30 p.m. EDT on May 13, 2014 until 11:59 p.m. EDT on May 20, 2014. To access the replay, please dial 1-888-286-8010 (domestic) or 1-617-801-6888 (international) and reference the access code 88784725. 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 Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic approach for the treatment of genetically defined forms of B-cell lymphoma and orphan autoimmune diseases. Idera's proprietary technology involves creating novel nucleic acid therapeutics designed to inhibit over-activation of Toll-like Receptors (TLRs). In addition to its TLR programs, Idera is developing gene silencing oligonucleotides 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, including in clinical trials in different disease indications; 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 United States 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 Quarterly Report on Form 10-Q for the three months ended March 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
March 31,
2014     2013

(Unaudited)

Revenues $ 3 $ 7
Operating Expenses
Research & Development 6,933 2,328
General & Administrative 2,043 1,527
Total Operating Expenses 8,976 3,855
Loss from Operations (8,973 ) (3,848 )
Other, net 12 41
Net Loss (8,961 ) (3,807 )
Preferred Stock Dividends 185 279
Net Loss Applicable to Common Stockholders $ (9,146 ) $ (4,086 )
Basic and Diluted Net Loss Per Common Share Applicable to Common Stockholders $ (0.12 ) $ (0.15 )
 
Shares Used in Computing Basic and Diluted Net Loss Per Common Share Applicable to Common Stockholders 76,018 27,644

 

             
Idera Pharmaceuticals, Inc.

Condensed Balance Sheet Data

(In thousands)

 
At March 31, At December 31,
2014 2013

(Unaudited)

Cash, Cash Equivalents & Investments $ 70,644 $ 35,592
Other Assets 1,596 1,275
Total Assets $ 72,240 $ 36,867
 
Total Liabilities $ 5,358 $ 4,415
Total Stockholders' Equity 66,882 32,452
Total Liabilities &
Stockholders' Equity $ 72,240 $ 36,867
 


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