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Idera Pharmaceuticals Reports First Quarter 2018 Financial Results and Provides Corporate Update

EXTON, Pa., May 09, 2018 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (“Idera”) (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 first quarter ended March 31, 2018.

“Our company continues to make significant progress advancing our two lead TLR modulating clinical development candidates, tilsotolimod and IMO-8400,” stated Vincent Milano, Idera’s chief executive officer.  Milano continued, “As we now advance through the second quarter, we are continuing to enroll patients in the ILLUMINATE oncology trials, with the next planned data from ILLUMINATE-204 in PD-1 refractory metastatic melanoma to be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting and completion of enrollment expected by year end.  For IMO-8400, we plan to report top-line data from our Phase 2 trial in dermatomyositis in June.  As it pertains to our nucleic acid chemistry research group, we completed our data analysis for IDRA-008 which has led us to a decision to not advance that program into the clinic.”

“In January of this year, we announced our proposed merger with BioCryst Pharmaceuticals, Inc. that we believe will build greater and more sustainable value for the benefit of stockholders as well as patients with rare diseases beyond what we could achieve alone. The Idera Board determined this combination was compelling from both a strategic and financial perspective following a careful evaluation of a range of strategies to enhance long-term stockholder value. The transaction will create a leading rare disease company with a robust pipeline including two promising Phase 3 rare disease programs and combines synergistic discovery engines that will not only expand the number of rare diseases we can target but create meaningful opportunities for differentiation in the market through joint small molecule and oligo treatments. Importantly, joining with BioCryst will also enable us to achieve cost synergies and increase our financial strength and flexibility.  Subject to shareholder approval, we expect to close the transaction in the third quarter,” Milano expressed.

Clinical Development Program Updates:
TLR Modulation Technology Development Candidates

ILLUMINATE (tilsotolimod) Clinical Development

ILLUMINATE 301 – Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with PD-1 refractory metastatic melanoma:

  • Trial initiated in Q1 2018;
  • Approximately 80 sites planned for trial participation across 12 countries;
  • Planned enrollment of approximately 300 patients with Overall Response Rate (“ORR”) and Overall Survival as primary endpoints; and
  • U.S. Food and Drug Administration granted Fast Track Designation for tilsotolimod in combination with ipilimumab for treatment of PD-1 refractory metastatic melanoma in fourth quarter of 2017.

ILLUMINATE 204 – Phase 1/2 trial of intratumoral tilsotolimod in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:

Ipilimumab Combination Arm – Phase 2 Expansion Ongoing at RP2D of 8mg

  • Enrollment (60 patients) completion expected by year end 2018;
  • 5 of the first 10 evaluable patients at the 8 mg dose of tilsotolimod were responders (50% ORR);
  • Additional data from the Phase 2 expansion of ILLUMINATE-204 selected for presentation at upcoming ASCO meeting in Chicago, IL.
    • Melanoma/Skin Cancers poster discussion session on June 4, 2018 at 4:45 PM CT; and
  • Investor/Analyst Event featuring lead ILLUMINATE-204 investigator, Adi Diab, MD from the University of Texas, MD Anderson Cancer Center to be held at 6:30 PM CT, also on June 4, 2018.  As a convenience to those unable to attend, this event will be webcast.

Pembrolizumab Combination Arm – Phase 1 Dose Escalation Ongoing

  • Enrollment into the last dosing cohort (32 mg) ongoing;
  • The previously reported partial response (PR) in 1 of the first 6 patients in the 16 mg cohort of intratumoral tilsotolimod in combination with pembrolizumab has evolved into a confirmed complete response (CR).

ILLUMINATE 101 – Phase 1b trial of intratumoral tilsotolimod monotherapy in patients with refractory solid tumors:

  • Completed enrollment in first two cohorts (11 patients treated with 8 mg dose of tilsotolimod, 8 patients treated with 16 mg dose of tilsotolimod);
  • Two patients in cohort 1 (8 mg) continue in follow-up; 2 patients in cohort 2 (16 mg) continue tilsotolimod monotherapy and two patients continue in follow-up; and 
  • 6 of 8 planned patients for cohort 3 (23 mg) enrolled. 

(IMO-8400) Development Activities

PIONEER-211 – Randomized placebo controlled Phase 2 trial of IMO-8400 in adult patients with dermatomyositis:

  • Enrollment concluded during Q3 2017 (30 patients); and
  • Topline phase 2 trial data expected in June 2018.

Nucleic Acid Chemistry Research Group

  • We are developing our nucleic acid chemistry technology to “turn off” the mRNA associated with disease causing genes. Our focus is on creating candidates targeted to specific genes to treat cancer and rare diseases.
  • We had selected IDRA-008 as our first nucleic acid chemistry research program candidate. IDRA-008 targets the Apolipoprotein C-III (APOC-III) gene and was being developed for the treatment of Familial Chylomicronemia Syndrome (FCS) and Familial Partial Lipodystrophy (FPL) which had available pre-clinical animal models and well-known clinical endpoints.
  • During the first quarter of 2018, we completed our pre-clinical analysis for IDRA-008 and based upon the outcome of pre-clinical pharmacology studies, including a comparative pharmacology study with the competitive development asset volanesorsen, and IND-enabling safety evaluation, we made a data-driven decision to not advance IDRA-008 into clinical development. 
  • We are currently conducting analysis throughout our research portfolio to identify other candidates for future clinical development based on our nucleic acid technology expertise and potential strategic commercial opportunity. 

Financial Results
First Quarter Results
Net loss applicable to common stockholders for the three months ended March 31, 2018 was $20.1 million, or $0.10 per basic and diluted share, compared to net loss applicable to common stockholders of $15.1 million, or $0.10 per basic and diluted share, for the same period in 2017. Revenue in each of the three months ended March 31, 2018 and 2017 was nominal.  Research and development expenses for the three months ended March 31, 2018 totaled $13.6 million compared to $11.5 million for the same period in 2017. General and administrative expense for the three months ended March 31, 2018 totaled $7.0 million compared to $4.1 million for the same period in 2017.

During the three months ended March 31, 2018, holders of warrants, including Baker Brothers, exercised warrants to purchase shares of the Idera’s common stock which generated $9.6 million in cash proceeds. As of March 31, 2018, our cash and cash equivalents totaled $107.5 million compared to $112.6 million as of December 31, 2017.  We currently anticipate that, based on our current operating plan and without taking into account the transaction with BioCryst Pharmaceuticals, Inc. (“BioCryst”), our existing cash, cash equivalents and investments will fund our operations into the third quarter of 2019.

Corporate Updates:

On January 22, 2018, BioCryst and Idera jointly announced the signing of a definitive merger agreement to create a company focused on the development and commercialization of medicines to serve patients suffering from rare diseases. The combined company will be renamed upon closing, and will be led by Vincent Milano, the current chief executive officer of Idera. Jon Stonehouse, the current chief executive officer of BioCryst, will serve as a member of the Board of Directors. The transaction is subject to approval by the stockholders of both companies, as well as the satisfaction of customary closing conditions. The transaction is expected to be completed by the end of the third quarter of 2018.

About Idera
Harnessing the approach of the earliest researchers in immunotherapy and Idera’s vast experience in developing proprietary immunology platforms, Idera’s lead development program is focused on priming the immune system to play a more powerful role in fighting cancer, ultimately increasing the number of people who can benefit from immunotherapy. Idera continues to invest in research and development, and is committed to working with investigators and partners who share the common goal of addressing the unmet needs of patients suffering from rare, life-threatening diseases. To learn more about Idera, visit www.iderapharma.com.

Additional Information and Where to Find It
In connection with the proposed mergers, Nautilus Holdco, Inc. (“Holdco”) has filed with the U.S. Securities and Exchange Commission (the “SEC”) a Registration Statement on Form S-4 (as may be amended from time to time, the “Registration Statement”) that includes the joint proxy statement/prospectus of BioCryst and Idera and that also will constitute a prospectus of Holdco. These materials are not yet final and will be amended. Once the Registration Statement is declared effective by the SEC, each of BioCryst and Idera will mail the definitive joint proxy statement/prospectus included therein to their respective stockholders. BioCryst, Idera and Holdco will also file other documents with the SEC regarding the proposed transaction. These documents are not substitutes for the definitive joint proxy/prospectus that will be filed by each of BioCryst and Idera with the SEC and mailed to stockholders. BEFORE MAKING ANY VOTING DECISION, IDERA’S AND BIOCRYST’S RESPECTIVE STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE JOINT PROXY STATEMENT/PROSPECTUS IN ITS ENTIRETY AND ANY OTHER DOCUMENTS FILED BY EACH OF IDERA AND BIOCRYST WITH THE SEC IN CONNECTION WITH THE PROPOSED MERGERS OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Investors and stockholders may obtain free copies of these materials and other documents filed with the SEC (when available) by BioCryst, Idera and Holdco through the website maintained by the SEC at www.sec.govIdera and BioCryst make available free of charge at www.iderapharma.com and www.biocryst.com, respectively (in the “Investors” section), copies of materials they file with, or furnish to, the SEC.

Participants in the Solicitation
This document does not constitute a solicitation of proxy, an offer to purchase or a solicitation of an offer to sell any securities. Idera, BioCryst and their respective directors, executive officers and certain employees and other persons may be deemed to be participants in the solicitation of proxies from the stockholders of Idera and BioCryst in connection with the proposed mergers. Security holders may obtain information regarding the names, affiliations and interests of Idera’s directors and officers in Idera’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, which was filed with the SEC on March 15, 2017 and its definitive proxy statement for the 2017 annual meeting of stockholders, which was filed with the SEC on April 28, 2017. Security holders may obtain information regarding the names, affiliations and interests of BioCryst’s directors and officers in BioCryst’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, which was filed with the SEC on February 27, 2017 and its definitive proxy statement for the 2017 annual meeting of stockholders, which was filed with the SEC on April 12, 2017. Additional information about the interests of BioCryst’s directors and officers and Idera’s directors and officers in the proposed mergers can be found in the above-referenced Registration Statement. These documents may be obtained free of charge from the SEC’s website at www.sec.gov, Idera’s website at www.iderapharma.com and BioCryst’s website at www.biocryst.com.

Forward-Looking Statements

These materials contain forward-looking statements within the meaning of the federal securities law, regarding, among other things, future events or the future financial performance of Idera and BioCryst.  Such statements are based upon current plans, estimates and expectations that are subject to various risks and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as “anticipate,” “expect,” “project,” “intend,” “believe,” “may,” “will,” “should,” “plan,” “could,” “target,” “contemplate,” “estimate,” “predict,” “potential” and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All forward-looking statements, other than historical facts, including statements regarding the expected timing of the closing of the mergers; the ability of the parties to complete the mergers considering the various closing conditions; the expected benefits of the mergers, such as efficiencies, cost savings, tax benefits, enhanced revenues and cash flow, growth potential, market profile and financial strength; the competitive ability and position of the combined company; Idera’s and BioCryst’s plans, objectives expectations and intentions; any assumptions underlying any of the foregoing; and any statements relating to the mergers, are forward-looking statements. Forward-looking statements are based on information currently available to Idera and BioCryst and involve estimates, expectations and projections. Investors are cautioned that all such forward-looking statements are subject to risks and uncertainties, and important factors that could cause actual events or results to differ materially from Idera’s and BioCryst’s plans, estimates or expectations. With respect to the transactions contemplated by the merger agreement between Idera and BioCryst, these factors could include, but are not limited to: (i) Idera or BioCryst may be unable to obtain stockholder approval as required for the mergers; (ii) conditions to the closing of the mergers may not be satisfied; (iii) the mergers may involve unexpected costs, liabilities or delays; (iv) the effect of the announcement of the mergers on the ability of Idera or BioCryst to retain and hire key personnel and maintain relationships with patients, doctors and others with whom Idera or BioCryst does business, or on Idera’s or BioCryst’s operating results and business generally; (v) Idera’s or BioCryst’s respective businesses may suffer as a result of uncertainty surrounding the mergers and disruption of management’s attention due to the mergers; (vi) the outcome of any legal proceedings related to the mergers; (vii) Idera or BioCryst may be adversely affected by other economic, business, and/or competitive factors; (viii) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (ix) risks that the mergers disrupt current plans and operations and the potential difficulties in employee retention as a result of the mergers; (x) the risk that Idera or BioCryst may be unable to obtain governmental and regulatory approvals required for the transactions, or that required governmental and regulatory approvals may delay the transactions or result in the imposition of conditions that could reduce the anticipated benefits from the transactions contemplated by the merger agreement or cause the parties to abandon the transactions contemplated by the merger agreement; (xi) risks that the anticipated benefits of the mergers or other commercial opportunities may otherwise not be fully realized or may take longer to realize than expected; (xii) the impact of legislative, regulatory, competitive and technological changes; (xiii) risks relating to the value of the new holding company shares to be issued in the mergers; (xiv) expectations for future clinical trials, the timing and potential outcomes of clinical studies and interactions with regulatory authorities; (xv) the risk that the credit ratings of the combined company or its subsidiaries may be different from what the companies expect; (xvi) economic and foreign exchange rate volatility; (xvii) the continued strength of the medical and pharmaceutical markets; (xviii) the timing, success and market reception for Idera’s and BioCryst’s products; (xix) the possibility of new technologies outdating Idera’s or BioCryst’s products; (xx) continued support of Idera’s or BioCryst’s products by influential medical professionals; (xxi) reliance on and integration of information technology systems; (xxii) the risks associated with assumptions the parties make in connection with the parties’ critical accounting estimates and legal proceedings; (xxiii) the potential of international unrest, economic downturn or effects of currencies, tax assessments, tax adjustments, anticipated tax rates, raw material costs or availability, benefit or retirement plan costs, or other regulatory compliance costs; and (xxiv) other risks to the consummation of the mergers, including the risk that the mergers will not be consummated within the expected time period or at all. These risks, as well as other risks associated with the proposed mergers, are more fully discussed in the joint proxy statement/prospectus included in the Registration Statement filed with the SEC in connection with the proposed mergers.

While the list of factors presented here is, and the list of factors presented in the Registration Statement is, considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward looking statements. Consequences of material differences in results as compared with those anticipated in the forward-looking statements could include, among other things, business disruption, operational problems, financial loss, legal liability to third parties and similar risks, any of which could have a material adverse effect on BioCryst’s or Idera’s consolidated financial condition, results of operations, credit rating or liquidity. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that Idera and BioCryst file from time to time with the SEC. The forward-looking statements in this document speak only as of the date of this document. Except as required by law, Idera and BioCryst assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.


Idera Pharmaceuticals, Inc.
Condensed Statements of Operations
(In thousands, except per share data)

  Three Months Ended 
  March 31, 
  2018   2017
   
Alliance revenue $   255   $   378
       
Operating expenses:      
Research and development 13,556   11,485
General and administrative 6,979   4,081
       
Total operating expenses 20,535   15,566
       
Loss from operations (20,280)   (15,188)
       
Other income (expense), net 185   131
       
Net loss $   (20,095)   $   (15,057)
       
Net loss per common share applicable to common stockholders — Basic and Diluted $   (0.10)   $   (0.10)
       
Weighted-average number of common shares used in computing net loss per share applicable to common stockholders — Basic and Diluted   199,037     149,100
       


Idera Pharmaceuticals, Inc.
Condensed Balance Sheet Data
(In thousands) 

  March 31,   December 31, 
  2018   2017
       
Cash, Cash Equivalents and Investments $   107,459   $   112,629
Other Assets   4,292     5,788
Total Assets $   111,751   $   118,417
       
Total Liabilities $   12,867   $   10,722
Total Stockholders' Equity   98,884     107,695
Total Liabilities and Stockholders' Equity $   111,751   $   118,417

Idera Pharmaceuticals Contact:

Robert A. Doody, Jr.
VP, Investor Relations & Communications
Phone (617) 679-5515
rdoody@iderapharma.com

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Source: Idera Pharmaceuticals, Inc.