IDRA Idera Pharmaceuticals Inc.

4.38
+0.25  (+6%)
Previous Close 4.13
Open 4.18
52 Week Low 0.813
52 Week High 4.9
Market Cap $154,398,456
Shares 35,250,789
Float 33,524,087
Enterprise Value $123,241,884
Volume 453,495
Av. Daily Volume 280,413
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Upcoming Catalysts

Drug Stage Catalyst Date
Tilsotolimod (IMO-2125) + ipilimumab - ILLUMINATE 301
Melanoma
Phase 3
Phase 3
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Tilsotolimod + nivolumab and ipilimumab - ILLUMINATE 206
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Tilsotolimod + ipilimumab - ILLUMINATE 204
Cancer - melanoma
Phase 2
Phase 2
Phase 2 final data announced April 20, 2020 - Overall response rate of 22%; Disease control rate of 71%.
Tilsotolimod - ILLUMINATE 101
Solid tumors
Phase 1
Phase 1
Phase 1b data at AACR April 2019 noted 45% disease control rate.
IMO-8400
Dermatomyositis
Phase 2
Phase 2
Phase 2 data released June 12, 2018 - primary endpoint not met.
IMO-8400
Waldenström’s Macroglobulinemia
Phase 1/2
Phase 1/2
Development suspended - September 2016.
IMO-8400
Diffuse Large B-cell Lymphoma (DLBCL)
Phase 1/2
Phase 1/2
Development suspended - September 2016.

Latest News

  1. COO Role is Key to Preparedness for NDA Filing and Commercial Launch
    Clayton Fletcher, Head of Business Development & Strategic Planning, to Retire

    EXTON, Pa., Nov. 17, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA, "Idera"))) today announced that Daniel Soland will join Idera on January 4, 2021, as Senior Vice President and Chief Operating Officer (COO). Mr. Soland has been engaged as a consultant to Idera for nearly three years. In his role as COO, he will be responsible for commercial strategy and manufacturing as Idera plans for success in anticipation of data from its pivotal trial, ILLUMINATE-301, which are currently expected in the first quarter of 2021.

    "In 2021, we expect to embark on our change from a…

    COO Role is Key to Preparedness for NDA Filing and Commercial Launch

    Clayton Fletcher, Head of Business Development & Strategic Planning, to Retire

    EXTON, Pa., Nov. 17, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA, "Idera"))) today announced that Daniel Soland will join Idera on January 4, 2021, as Senior Vice President and Chief Operating Officer (COO). Mr. Soland has been engaged as a consultant to Idera for nearly three years. In his role as COO, he will be responsible for commercial strategy and manufacturing as Idera plans for success in anticipation of data from its pivotal trial, ILLUMINATE-301, which are currently expected in the first quarter of 2021.

    "In 2021, we expect to embark on our change from a development-stage company to a commercial company. In anticipation of that, I am delighted that we will be adding Dan's extensive expertise and leadership to our Idera team," stated Mr. Milano. "Dan's leadership of our marketing, sales, manufacturing, and distribution strategy and operations will be invaluable to us on our journey to bring tilsotolimod to patients in need."

    Mr. Soland is an accomplished leader in the biotech industry. He most recently served as the Chief Executive Officer of uniQure N.V. and, prior to that, Senior Vice President & COO of ViroPharma Inc. While at ViroPharma, Mr. Soland managed the commercial, manufacturing, and quality organizations, helped build the company's commercial infrastructure in the U.S., Europe, and Canada, and led the launch of Cinryze® (C1 esterase inhibitor [human]), one of the most successful ultra-orphan drug launches in the U.S. Mr. Soland served as President, Chiron Vaccines, of Chiron Corporation from 2005 to 2006 and led the growth of the vaccine business to over $1 billion in sales. From 2002 through 2005, Mr. Soland served as President and Chief Executive Officer of Epigenesis Pharmaceuticals. Earlier in his career, Mr. Soland worked for GlaxoSmithKline in increasing roles of responsibility, including as Vice President and Director, Worldwide Marketing Operations, GSK Biologicals. He currently serves on the Board of Directors of Acadia Pharmaceuticals, Inc., DBV Technologies SA, and KalVista Pharmaceuticals, Inc. Mr. Soland earned his B.S. in Pharmacy from the University of Iowa.

    "I'm excited and honored to join the Idera team at this pivotal juncture and to help prepare the company for the anticipated success of tilsotolimod in advanced refractory melanoma and beyond," stated Mr. Soland. "I believe tilsotolimod represents tremendous possibilities for patients as well as untapped potential for Idera, and I am excited to help the company achieve its goals."

    Idera also announced that R. Clayton Fletcher, Senior Vice President of Business Development and Strategic Planning, will retire at the end of 2020. Mr. Fletcher will remain as a consultant to the Company, continuing to lead its business development activities.

    Mr. Fletcher joined Idera in February 2015 and has been responsible for leading the company's business development, portfolio management and planning, manufacturing, and corporate operations activities.

    "Clayton's time at Idera caps a successful career that spans three decades. I have had the honor of working with him for nearly twenty years and am extremely grateful for his partnership, leadership, and friendship over that time," stated Vincent Milano, Idera's Chief Executive Officer. "Clayton's aptitude for, and contribution to, every aspect of our business is substantial. I am grateful that, even in his retirement, he has asked to continue leading our business development efforts as a consultant."

    Mr. Fletcher is retiring after 30 years in the biotech industry, rising from his first role as a bench scientist at Centocor Inc. in 1991. Prior to joining Idera, Mr. Fletcher spent 13 years at ViroPharma Inc. as Vice President, Business Development & Project Management, a member of the management team, and a key contributor to its acquisition, development, and commercialization of innovative therapies for rare diseases. He also held scientific and project management position at Intracel, Becton Dickson, and SmithKline Beecham. Mr. Fletcher received B.S. and M.S. degrees in biology from Wake Forest University.

    "I am looking forward to the next chapter in my life, which includes spending more quality time with my wife and family. My colleagues at Idera have been my extended family for over five years and, while I will miss the day-to-day interactions, I look forward to staying connected as a consultant," stated Mr. Fletcher. "I am proud of the terrific team at Idera and am confident in their ongoing success with tilsotolimod and beyond."

    About Tilsotolimod

    Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate and adaptive immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

    Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint and costimulation therapies. For more information on tilsotolimod trials, please visit ClinicalTrials.gov.

    About Idera Pharmaceuticals

    Harnessing the approach of the earliest researchers in immunotherapy and the company's vast experience in developing proprietary immunology platforms, Idera's 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 also continues to focus on the acquisition, development, and ultimate commercialization of drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet needs. To learn more about Idera, visit www.iderapharma.com.

    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, clinical trials, 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 the Company's cash resources will be sufficient to fund the Company's continuing operations and the further development of the Company's programs for the period anticipated; whether the Company will require additional financing and whether such financing will be available on terms that the Company will find attractive; our dependence on our TLR-targeted clinical-stage drug candidates; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials 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 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; risks related to competition; and such other important factors as are set forth under the caption "Risk Factors" in the Company's Annual Report filed on Form 10-K for the period ended December 31, 2019, and the Company's other filings with the Securities and Exchange Commission. 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, except as may be required by law.

    Idera Pharmaceuticals Contacts:

    Jill Conwell

    Investor Relations &

    Corporate Communications

    Phone (484) 348-1675

    John J. Kirby

    Chief Financial Officer

    Phone (484) 348-1627

     



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  2. EXTON, Pa., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (NASDAQ:IDRA) today reported its financial and operational results for the third quarter ended September 30, 2020.

    "Tilsotolimod is the most advanced TLR-9 agonist therapy in development, and we have made tremendous strides against our objectives for 2020," stated Vincent Milano, Idera's Chief Executive Officer. "We continue to work diligently against our timelines for ILLUMINATE-301, which currently remain on track for data in the first quarter of 2021. In addition, our recent patent and allowed application for tilsotolimod method-of-use in colorectal and head and neck cancers as well as the continuation of ILLUMINATE-206 reinforce our ‘beyond…

    EXTON, Pa., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (NASDAQ:IDRA) today reported its financial and operational results for the third quarter ended September 30, 2020.

    "Tilsotolimod is the most advanced TLR-9 agonist therapy in development, and we have made tremendous strides against our objectives for 2020," stated Vincent Milano, Idera's Chief Executive Officer. "We continue to work diligently against our timelines for ILLUMINATE-301, which currently remain on track for data in the first quarter of 2021. In addition, our recent patent and allowed application for tilsotolimod method-of-use in colorectal and head and neck cancers as well as the continuation of ILLUMINATE-206 reinforce our ‘beyond melanoma' strategy. We also have the financing to help our outstanding team continue to execute these key objectives."

    Corporate Update

    Since June 30, 2020, the following corporate updates were announced:

    • The Company entered into a private placement of up to $20.0 million, with $5.1 million received in July 2020. The Company anticipates that its current cash, cash equivalents, and short-term investments will fund our operations through the second quarter of 2021. With this private placement, the Company has now entered into three financing vehicles since December 2019, which it believes could provide proceeds of up to $118.2 million to fund the potential NDA filing and commercial launch of tilsotolimod.
    • The Company received a new U.S. Patent and allowed application for tilsotolimod, providing exclusivity through September 2037 when intratumoral tilsotolimod is used with certain immune checkpoint inhibitors in treating colorectal cancer (CRC) and head and neck squamous cell carcinoma (HNSCC).

    ILLUMINATE (tilsotolimod) Clinical Development Updates



    ILLUMINATE-301: Randomized phase 3 trial of tilsotolimod in combination with Yervoy®* (ipilimumab) versus Yervoy® alone in patients with anti-PD-1 refractory advanced melanoma:

    • Primary endpoint family of overall response rate (ORR) by blinded independent central review using RECIST v1.1 and overall survival (OS);
    • Trial initiated in March 2018;
    • Enrollment completed in March 2020; and
    • ORR and other preliminary data expected in the first quarter of 2021.

    ILLUMINATE-206: Phase 2, open-label, multicohort, multicenter study to test the safety and effectiveness of tilsotolimod in combination with Yervoy® and Opdivo®* (nivolumab) for the treatment of solid tumors:

    • Trial initiated in September 2019 with the microsatellite stable colorectal cancer (MSS-CRC) cohort;
    • Initial safety run-in of 10 patients, which included Yervoy® at 1 mg/kg every 8 weeks and Opdivo® at 3 mg/kg every 2 weeks, showed that the regimen was generally well tolerated;
    • Changes in the study design intended to improve potential outcomes in this patient population include increasing Yervoy® dosing frequency to every 3 weeks and limiting the number of allowed prior lines of treatment to 2; and
    • The Company has opened enrollment for the next 10 patients under the modified study design, with data anticipated in the second quarter of 2021.

    ILLUMINATE-204: Phase 1/2 trial of tilsotolimod in combination with Yervoy® or Keytruda®± (pembrolizumab) in patients with anti-PD-1 refractory advanced melanoma:

    • Final results from the recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in combination with Yervoy®, which is the treatment regimen being evaluated in the Company's registrational trial, ILLUMINATE-301, were shared in a Mini Oral presentation at the ESMO Virtual Congress in September 2020.

    Third Quarter Financial Results

    Research and development expenses for the three months ended September 30, 2020, totaled $4.8 million compared to $8.4 million for the same period in 2019. General and administrative expense for the three months ended September 30, 2020, totaled $2.7 million compared to $3.0 million for the same period in 2019. Additionally, during the three months ended September 30, 2020, we recorded $0.7 million and $12.4 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to securities issued in connection with our December 2019 private placement transaction.

    As a result of the factors above, net loss applicable to common stockholders for the three months ended September 30, 2020, was $20.6 million, or $0.59 per basic and diluted share, compared to net loss applicable to common stockholders of $11.1 million, or $0.39 per basic and diluted share, for the same period in 2019. Excluding the non-cash loss of approximately $13.1 million for the three months ended September 30, 2020, related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $7.5 million, or $0.21 per basic and diluted share (calculated based upon the basic weighted-average number of common shares, due to the antidilutive effect of net loss).



    As of September 30, 2020, our cash, cash equivalents, and short-term investments totaled $29.0 million. Based on our current operating plan, we anticipate that our current cash, cash equivalents, and short-term investments, will fund our operations through the second quarter of 2021.

    About Idera Pharmaceuticals

    Harnessing the approach of the earliest researchers in immunotherapy and the Company'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 also continues to focus on the acquisition, development and ultimate commercialization of drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet needs. To learn more about Idera, visit IderaPharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the safe harbor of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, financial position, funding for continued operations, and clinical trials, including the enrollment, timing, and future results thereof, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," "schedule," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on the Company's current expectations and projections about future events and various assumptions. 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. These forward-looking statements involve known and unknown risks, uncertainties, and other factors, which may be beyond Idera's control, and which may cause the actual results, performance, or achievements of the Company to be materially different from future results, performance, or achievements expressed or implied by such 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 including, without limitation: whether the Company's cash resources will be sufficient to fund the Company's continuing operations and the further development of the Company's programs; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials 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 when anticipated or at all or warrant submission for regulatory approval; whether such products will 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's collaborations will be successful; and the impact of public health crises, including the novel coronavirus (COVID-19) global pandemic. All forward-looking statements included in this release are made as of the date hereof, and are expressly qualified in their entirety by this cautionary notice, including, without limitation, those risks and uncertainties described in the Company's Annual Report on Form 10-K for the year ended December 31, 2019, and otherwise in the Company's filings and reports filed with Securities and Exchange Commission. While 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, except as may be required by law.

    *Yervoy (ipilimumab) and Opdivo (nivolumab) are registered trademarks of Bristol Myers Squibb.

    ±Keytruda (pembrolizumab) is a registered trademark of Merck Sharp & Dohme, a subsidiary Merck & Co., Inc.



    Idera Pharmaceuticals, Inc.

    Statements of Operations

    (In thousands, except per share data)

      Three Months Ended  Nine Months Ended  
      September 30, September 30, 
       2020   2019   2020   2019  
        
    Alliance revenue $-  $-  $-  $1,448  
                
    Operating expenses:         
    Research and development  4,766   8,359   19,655   26,485  
    General and administrative  2,718   3,023   8,992   9,061  
    Restructuring costs  -   5   -   181  
              
    Total operating expenses  7,484   11,387   28,647   35,727  
              
    Loss from operations  (7,484)  (11,387)  (28,647)  (34,279) 
              
    Other income (expense)         
    Warrant revaluation loss  (683)  -   (495)  -  
    Future tranche right revaluation loss  (12,350)  -   (6,988)  -  
    Other income (expense), net  (35)  254   169   996  
              
    Net loss $(20,552) $(11,133) $(35,961) $(33,283) 
              
    Net loss per common share applicable to common stockholders— basic and diluted $(0.59) $(0.39) $(1.09) $(1.17) 
              
    Weighted-average number of common shares used in computing net loss per share applicable to common stockholders— basic and diluted  35,091   28,847   32,999   28,332  
              





    Idera Pharmaceuticals, Inc.

    Balance Sheet Data

    (In thousands)

         
     September 30, December 31,  
      2020 2019 
         
    Cash, cash equivalents, and short-term investments$28,979  $42,793  
    Other assets 3,359   4,696  
    Total assets$32,338  $47,489  
         
    Total liabilities$64,773  $58,657  
    Total stockholders' deficit (32,435)  (11,168) 
    Total liabilities and stockholders' deficit$32,338  $47,489  
         

     



    Idera Pharmaceuticals Contacts:



    Jill Conwell

    Investor Relations &

    Corporate Communications

    Phone (484) 348-1675

    John J. Kirby

    Chief Financial Officer

    Phone (484) 348-1627

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  3. EXTON, Pa., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA) today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 10,772,907 (the ‘907 Patent) and allowed U.S. Patent Application No. 16/557,597 (the ‘597 Application), both entitled "Immune Modulation with TLR9 Agonists for Cancer Treatment" and each of which includes the Company's investigational therapy tilsotolimod.

    The new patent and allowed application each include 26 claims directed to methods of treating colorectal cancer (CRC) (the ‘907 Patent) and head and neck squamous cell carcinoma (HNSCC) (the ‘597 Application) with intratumoral administration of tilsotolimod in combination with certain immune checkpoint inhibitor therapies…

    EXTON, Pa., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA) today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 10,772,907 (the ‘907 Patent) and allowed U.S. Patent Application No. 16/557,597 (the ‘597 Application), both entitled "Immune Modulation with TLR9 Agonists for Cancer Treatment" and each of which includes the Company's investigational therapy tilsotolimod.

    The new patent and allowed application each include 26 claims directed to methods of treating colorectal cancer (CRC) (the ‘907 Patent) and head and neck squamous cell carcinoma (HNSCC) (the ‘597 Application) with intratumoral administration of tilsotolimod in combination with certain immune checkpoint inhibitor therapies, including CTLA-4, PD-1 or PD-L1 proteins. This new coverage expands protection of the first tilsotolimod method-of-use patent, which was directed to methods of treating metastatic melanoma and was issued in November 2019. The patents and the allowed application provide exclusivity for certain uses of tilsotolimod through September 2037.

    "The CRC patent and the soon-to-issue HNSCC patent fortify our ‘beyond melanoma' strategy for tilsotolimod, which currently includes ongoing development in MSS-CRC via our ILLUMINATE-206 trial and in HNSCC via our collaboration with AbbVie," said Vincent Milano, Idera's Chief Executive Officer. "These additional new intellectual property protections also demonstrate our commitment to tilsotolimod and to furthering its development potentially to address unmet need for patients living with cancer."

    About MSS-CRC and ILLUMINATE-206

    Colorectal cancer involves the abnormal growth of cells in the colon or rectum. This type of cancer is typically tested to determine its "MSI" status, which will inform treatment approach and prognosis. MSI stands for "microsatellite instable." MSI-High (MSI-H) means that there is a high amount of instability in a tumor, whereas MSS tumors are "microsatellite stable." According to the American Cancer Society and other references, annually in the United States, approximately 140,000 people are diagnosed with CRC, of which 85% are MSS, and approximately 50,000 deaths are attributed to CRC.

    MSS-CRC has been shown to be highly immunosuppressive; there are no approved immunotherapy options. Given tilsotolimod's mechanism of action of activating dendritic cells, it may serve a complementary function to Yervoy® and Opdivo® within the immunosuppressive tumor microenvironment of MSS-CRC patients.

    ILLUMINATE-206 is a Phase 2, open-label, multi-center study to evaluate tilsotolimod in combination with Opdivo® and Yervoy®* in immunotherapy-naive micro-satellite stable colorectal cancer (MSS-CRC) patients. For more information on this trial, please visit ClinicalTrials.gov.

    About HNSCC and the AbbVie Collaboration

    Head and neck squamous cell carcinoma (HNSCC) develop in the flat, scale-like cells that form the lining of the mouth, nose, and throat. If HNSCC metastasizes to other parts of the body, such as the lymph nodes or lungs, the cancer has a worse prognosis and can be fatal. HNSCC is the seventh most common cancer worldwide. Each year, approximately 50,000 new cases are diagnosed and approximately 11,000 deaths are attributed to HNSCC in the United States.

    In patients with relapsed or metastatic HNSCC, an overall survival benefit has been demonstrated for anti-PD-1 immune therapies versus standard of care chemotherapy. The challenge remains to increase the percentage of patients responding to these treatments, which currently ranges from 13% to 23%, depending on the line of therapy. Given tilsotolimod's mechanism of action of activating dendritic cells, it may serve a complementary function to immune therapies within the tumor microenvironment of HNSCC patients.

    For more information regarding Idera's collaboration with AbbVie in HNSCC, see Idera's September 2019 press release or visit ClinicalTrials.gov.

    About Tilsotolimod (IMO-2125)

    Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate and adaptive immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy. Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint and costimulation therapies. For more information on tilsotolimod trials, please visit ClinicalTrials.gov.

    About Idera Pharmaceuticals

    Harnessing the approach of the earliest researchers in immunotherapy and the company's vast experience in developing proprietary immunology platforms, Idera's 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 also continues to focus on the acquisition, development, and ultimate commercialization of drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet needs. To learn more about Idera, visit IderaPharma.com.

    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, clinical trials, 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 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 several 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 the Company's cash resources will be sufficient to fund the Company's continuing operations and the further development of the Company's programs for the period anticipated; whether interim results from a clinical trial, such as the preliminary results reported in this release, will be predictive of the final results of the trial; 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 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 filed on Form 10-K for the period ended December 31, 2017 and the Company's Quarterly Report filed on Form 10-Q for the period ended September 30, 2018. 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.

    *Yervoy (ipilimumab) and Opdivo (nivolumab) are registered trademarks of Bristol Myers Squibb.

    Idera Pharmaceuticals Contacts:
    
    Jill Conwell
    Investor Relations &
    Corporate Communications
    Phone (484) 348-1675
    
    
    John J. Kirby
    Chief Financial Officer
    Phone (484) 348-1627
    

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    • Final data from ILLUMINATE-204 trial in advanced melanoma and final results from ILLUMINATE-101 trial in refractory solid tumors to be presented
    • AbbVie to present a trial-in-progress poster of ABBV-368 in combination with tilsotolimod in recurrent / metastatic head and neck squamous cell carcinoma (HNSCC)
    • Idera also to present at H.C. Wainwright 22nd Annual Global Investment Conference

    EXTON, Pa., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ:IDRA) today announced that final data from the ILLUMINATE-204 trial investigating intratumoral tilsotolimod, Idera's investigational Toll-like receptor 9 (TLR9) agonist, will be presented in a Mini Oral presentation at the European Society for Medical Oncology (ESMO) Virtual

    • Final data from ILLUMINATE-204 trial in advanced melanoma and final results from ILLUMINATE-101 trial in refractory solid tumors to be presented
    • AbbVie to present a trial-in-progress poster of ABBV-368 in combination with tilsotolimod in recurrent / metastatic head and neck squamous cell carcinoma (HNSCC)
    • Idera also to present at H.C. Wainwright 22nd Annual Global Investment Conference

    EXTON, Pa., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ:IDRA) today announced that final data from the ILLUMINATE-204 trial investigating intratumoral tilsotolimod, Idera's investigational Toll-like receptor 9 (TLR9) agonist, will be presented in a Mini Oral presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, to be held September 19-21, 2020. In addition, final results from ILLUMINATE-101 will be shared in a poster presentation.

    ILLUMINATE-204 is a multi-center, two-arm phase 1/2 trial in patients with anti-PD-1 refractory advanced melanoma. The phase 1 portion of the trial tested the safety and efficacy of increasing doses of tilsotolimod in combination with either Yervoy®* (ipilimumab) or Keytruda®† (pembrolizumab). The phase 2 expansion of the trial enrolled additional patients at the recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in combination with Yervoy®, which is the treatment regimen being evaluated for the same indication in the Company's registrational trial, ILLUMINATE-301. Adi Diab, M.D., of The University of Texas MD Anderson Cancer Center, will be delivering the Mini-Oral presentation as part of the Mini Oral Session on Melanoma and Other Skin Tumors.

    ILLUMINATE-101 is a phase 1b trial evaluating intratumoral tilsotolimod monotherapy in patients with refractory solid tumors, which was completed in December 2019. Final results for ILLUMINATE-101 will be presented by Hani M. Babiker, M.D., of the University of Arizona Cancer Center.

    In addition to presentations on these Idera-sponsored trials, AbbVie will be presenting a trial-in-progress poster on their phase 1b study to determine the safety, tolerability, pharmacokinetics, and preliminary efficacy of combinations of ABBV-368 plus tilsotolimod in subjects with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This trial is being conducted as part of an immuno-oncology clinical research collaboration between Idera and AbbVie.

    The presentation titles are as follows:

    • 1083MO: Final Results from ILLUMINATE-204, a Phase 1/2 Trial of Intratumoral Tilsotolimod in Combination with Ipilimumab in PD-1 Inhibitor Refractory Advanced Melanoma
    • 1031P: Tilsotolimod Engages the TLR9 Pathway to Promote Antigen Presentation and Type I IFN Signaling in Solid Tumors
    • 975TiP: Phase 1b Trial of ABBV-368 + Tilsotolimod in Combination With Nab-Paclitaxel and/or Budigalimab (ABBV-181) in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

    The on-demand poster and oral presentations will be available beginning on Thursday, September 17 and Friday, September 18, respectively.

    "We are very pleased that Dr. Diab will present final data from our phase 2 trial exploring tilsotolimod plus ipilimumab in advanced melanoma patients," stated Elizabeth Tarka, M.D., Idera's Chief Medical Officer. "We are looking forward to completing our registrational trial for this indication, ILLUMINATE-301, where a comparator arm is included, and moving this potential therapy one step closer to those patients in need."

    Idera also announced that the company will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 1:30 pm EDT. A live audio webcast of Idera's presentation will be accessible in the Investor Relations section of Idera's website at www.iderapharma.com.

    About Tilsotolimod (IMO-2125)

    Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate and adaptive immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

    Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint and costimulation therapies. For more information on tilsotolimod trials, please visit ClinicalTrials.gov.

    About Idera Pharmaceuticals

    Harnessing the approach of the earliest researchers in immunotherapy and the company's vast experience in developing proprietary immunology platforms, Idera's 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 also continues to focus on the acquisition, development, and ultimate commercialization of drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet needs. To learn more about Idera, visit IderaPharma.com.

    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, clinical trials, plans, and objectives of management, are forward-looking statements. The words "believes," "expects," "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 the Company's cash resources will be sufficient to fund the Company's continuing operations and the further development of the Company's programs for the period anticipated; whether interim results from a clinical trial, such as the preliminary results reported in this release, will be predictive of the final results of the trial; 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 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 filed on Form 10-K for the period ended December 31, 2019. 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.

    *Yervoy (ipilimumab) is a registered trademark of Bristol Myers Squibb Company.

    †Keytruda (pembrolizumab) is a registered trademark of Merck Sharp & Dohme Corp. 

    Idera Pharmaceuticals Contacts:
    
    Jill Conwell
    Investor Relations & 
    Corporate Communications
    Phone (484) 348-1675
    
    
    John J. Kirby
    Chief Financial Officer
    Phone (484) 348-1627
    

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  4. EXTON, Pa., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (NASDAQ:IDRA) today reported its financial and operational results for the second quarter ended June 30, 2020.

    "Idera meaningfully advanced its clinical pipeline and strengthened its financial resources in the first part of 2020. Further encouraged by data from ILLUMINATE-204, which we reported in the second quarter, we continue to work diligently against our timelines for ILLUMINATE-301. Those timelines currently remain on track for data in the first quarter of 2021, despite disruptions from the global impact of COVID-19," stated Vincent Milano, Idera's Chief Executive Officer.  "In addition, as part of our ‘beyond melanoma' strategy, early…

    EXTON, Pa., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (NASDAQ:IDRA) today reported its financial and operational results for the second quarter ended June 30, 2020.

    "Idera meaningfully advanced its clinical pipeline and strengthened its financial resources in the first part of 2020. Further encouraged by data from ILLUMINATE-204, which we reported in the second quarter, we continue to work diligently against our timelines for ILLUMINATE-301. Those timelines currently remain on track for data in the first quarter of 2021, despite disruptions from the global impact of COVID-19," stated Vincent Milano, Idera's Chief Executive Officer.  "In addition, as part of our ‘beyond melanoma' strategy, early data from ILLUMINATE-206 reinforces our optimism in the potential of tilsotolimod in patients with micro-satellite stable colorectal cancer. Lastly, our team's outstanding perseverance and dedication to our patients combined with the further financing we recently secured will help us continue to execute these key objectives and potentially beyond."

    Corporate Update

    Since March 31, 2020, the Company entered into two private placement financings of up to $40.7 million, with $5.0 million received in April 2020 and $5.1 million received in July 2020. The Company anticipates that its current cash, cash equivalents, and short-term investments will fund our operations into the second quarter of 2021. With the Company's current financing vehicles, there exists the possibility to extend that runway through subsequent proceeds to fund the potential NDA filing and commercial launch of tilsotolimod.

    ILLUMINATE (tilsotolimod) Clinical Development Updates



    ILLUMINATE-301: Randomized phase 3 trial of tilsotolimod in combination with Yervoy®* (ipilimumab) versus Yervoy® alone in patients with anti-PD-1 refractory advanced melanoma:

    • Primary endpoint family of overall response rate (ORR) by blinded independent review using RECIST v1.1 and overall survival (OS);
    • Trial initiated in March 2018;
    • Enrollment completed in March 2020; and
    • ORR and other preliminary data expected in the first quarter of 2021.

    ILLUMINATE-206: Phase 2, open-label, multicohort, multicenter study to test the safety and effectiveness of tilsotolimod in combination with Yervoy® and Opdivo®* (nivolumab) for the treatment of solid tumors:

    • Trial initiated in September 2019 with the microsatellite stable colorectal cancer (MSS-CRC) cohort;
    • Initial safety run-in of 10 patients, which included Yervoy® at 1 mg/kg every 8 weeks and Opdivo® at 3 mg/kg every 2 weeks, showed that the regimen was generally well tolerated;
    • Planned changes in the study design intended to improve potential outcomes in this patient population include increasing Yervoy® dosing frequency to every 3 weeks and limiting the number of allowed prior lines of treatment to 2; and
    • Enrollment of the next 10 patients is targeted to begin in the fourth quarter of 2020, with data anticipated in the second quarter of 2021.

    ILLUMINATE-204: Phase 1/2 trial of tilsotolimod in combination with Yervoy® or Keytruda®± (pembrolizumab) in patients with anti-PD-1 refractory advanced melanoma:

    • Final topline results released in April 2020 from the recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in combination with Yervoy®, which is the treatment regimen being evaluated in the Company's registrational trial, ILLUMINATE-301; and
    • Final data from the trial will be shared in a Mini Oral presentation at the ESMO Virtual Congress 2020, to be held September 19-21, 2020.

    Second Quarter Financial Results

    Research and development expenses for the three months ended June 30, 2020 totaled $5.4 million compared to $10.0 million for the same period in 2019. General and administrative expense for the three months ended June 30, 2020 totaled $2.6 million compared to $2.9 million for the same period in 2019. Additionally, during the three months ended June 30, 2020, we recorded $0.9 million and $15.3 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to securities issued in connection with our December 2019 private placement transaction.

    As a result of the factors above, net loss applicable to common stockholders for the three months ended June 30, 2020 was $24.2 million, or $0.72 per basic and diluted share, compared to net loss applicable to common stockholders of $11.2 million, or $0.39 per basic and diluted share, for the same period in 2019. Excluding the non-cash loss of approximately $16.3 million for the three months ended June 30, 2020 related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $8.0 million, or $0.24 per basic and diluted share (calculated based upon the basic weighted-average number of common shares, due to the antidilutive effect of net loss).

    As of June 30, 2020, our cash, cash equivalents, and short-term investments totaled $31.0 million. Based on our current operating plan, we anticipate that our current cash, cash equivalents, and short-term investments, including $5.1 million gross proceeds in cash received in July 2020 pursuant to the July 2020 Securities Purchase Agreement, will fund our operations into the second quarter of 2021.

    About Idera Pharmaceuticals

    Harnessing the approach of the earliest researchers in immunotherapy and the Company'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 also continues to focus on the acquisition, development and ultimate commercialization of drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet needs. To learn more about Idera, visit IderaPharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the safe harbor of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, financial position, funding for continued operations, and clinical trials, including the enrollment, timing, and future results thereof, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," "schedule," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on the Company's current expectations and projections about future events and various assumptions. 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. These forward-looking statements involve known and unknown risks, uncertainties, and other factors, which may be beyond Idera's control, and which may cause the actual results, performance, or achievements of the Company to be materially different from future results, performance, or achievements expressed or implied by such 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 including, without limitation: whether the Company's cash resources will be sufficient to fund the Company's continuing operations and the further development of the Company's programs; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials 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 when anticipated or at all or warrant submission for regulatory approval; whether such products will 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's collaborations will be successful; and the impact of public health crises, including the novel coronavirus (COVID-19) global pandemic. All forward-looking statements included in this release are made as of the date hereof, and are expressly qualified in their entirety by this cautionary notice, including, without limitation, those risks and uncertainties described in the Company's Annual Report on Form 10-K for the year ended December 31, 2019, and otherwise in the Company's filings and reports filed with Securities and Exchange Commission. While 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, except as may be required by law.

    *Yervoy (ipilimumab) and Opdivo (nivolumab) are registered trademarks of Bristol Myers Squibb.

    ±Keytruda (pembrolizumab) is a registered trademark of Merck Sharp & Dohme, a subsidiary Merck & Co., Inc.

     
    Idera Pharmaceuticals, Inc.

    Statements of Operations

    (In thousands, except per share data)
     
      Three Months Ended  Six Months Ended  
      June 30, June 30, 
       2020   2019   2020   2019  
                      
    Alliance revenue $-  $1,448  $-  $1,448  
             -  
    Operating expenses:         
    Research and development  5,379   10,024   14,889   18,126  
    General and administrative  2,632   2,895   6,274   6,038  
    Restructuring costs  -   45   -   176  
              
    Total operating expenses  8,011   12,964   21,163   24,340  
              
    Loss from operations  (8,011)  (11,516)  (21,163)  (22,892) 
              
    Other income (expense)         
    Warrant revaluation (loss) gain  (913)  -   188   -  
    Future tranche right revaluation (loss) gain  (15,349)  -   5,362   -  
    Other income (expense), net  47   340   204   742  
              
    Net loss $(24,226) $(11,176) $(15,409) $(22,150) 
              
    Net loss per common share applicable to common stockholders         
    — basic $(0.72) $(0.39) $(0.48) $(0.79) 
    — diluted $(0.72) $(0.39) $(0.52) $(0.79) 
              
    Weighted-average number of common shares used in computing net loss per share applicable to common stockholders         
    — basic  33,583   28,461   31,941   28,070  
    — diluted  33,583   28,461   34,123   28,070  
              



     
    Idera Pharmaceuticals, Inc.

    Balance Sheet Data

    (In thousands)
        
     June 30, December 31,
      2020   2019 
        
    Cash, cash equivalents, and short-term investments$31,006  $42,793 
    Other assets 3,779   4,696 
    Total assets$34,785  $47,489 
        
    Total liabilities$52,476  $58,657 
    Total stockholders' deficit (17,691)  (11,168)
    Total liabilities and stockholders' deficit$34,785  $47,489 
        



    IDERA PHARMACEUTICALS Contacts:
    
    Jill Conwell 
    Investor Relations & 
    Corporate Communications 
    Phone (484) 348-1675
    
    
    John J. Kirby
    Chief Financial Officer
    Phone (484) 348-1627
    

    Primary Logo

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