IDRA Idera Pharmaceuticals Inc.

2
+0.07  (+4%)
Previous Close 1.93
Open 1.93
52 Week Low 0.813
52 Week High 3.58
Market Cap $70,398,492
Shares 35,199,246
Float 33,504,792
Enterprise Value $42,485,446
Volume 131,396
Av. Daily Volume 330,907
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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. 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
    

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  2. EXTON, Pa., July 15, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA) today announced entering into an agreement with a fund affiliated with institutional investors providing for a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, pursuant to which Idera has sold shares of common stock (or common stock equivalents), together with accompanying warrants to purchase an additional shares of common stock, for aggregate gross proceeds of $5.1 million (Tranche 1). The combined purchase price per share of common stock (or common stock equivalent) and accompanying full warrant was $1.845. The common stock warrants have an exercise price of $2.58 per share and a term of three years…

    EXTON, Pa., July 15, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA) today announced entering into an agreement with a fund affiliated with institutional investors providing for a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, pursuant to which Idera has sold shares of common stock (or common stock equivalents), together with accompanying warrants to purchase an additional shares of common stock, for aggregate gross proceeds of $5.1 million (Tranche 1). The combined purchase price per share of common stock (or common stock equivalent) and accompanying full warrant was $1.845. The common stock warrants have an exercise price of $2.58 per share and a term of three years and are exercisable at any time or times, provided that the investors will be prohibited from exercising a common warrant for shares of common stock to the extent that the investors would beneficially own in excess of 19.99% of the total number of shares of common stock then issued and outstanding (Beneficial Ownership Limitation).

    Pursuant to the agreement, the investors may, at their option, make a further investment of an additional $5.1 million to purchase shares of common stock equivalents, together with accompanying common stock warrants to purchase additional shares of common stock with 35% warrant coverage (Tranche 2). The combined purchase price per share of common stock (or common stock equivalent) and accompanying 0.35 warrant will be $6.50 per share. The common stock warrants, if issued, will have an exercise price of $9.75 per share, a term of three years and are exercisable at any time or times, provided that the investors will be prohibited from exercising a common warrant for shares of common stock to the extent that the investors would beneficially own in excess of the Beneficial Ownership Limitation.

    The investors' option to invest in Tranche 2 must occur no later than the tenth business day following the announcement of overall response rate data from the Company's ILLUMINATE-301 trial of its lead product, tilsotolimod, in combination with ipilimumab for the treatment of anti-PD-1 refractory advanced melanoma. To the extent Tranche 2 is closed and inclusive of proceeds from the exercise of warrants issuable in this private placement, the Company may receive up to $20.0 million in gross proceeds.

    The Company plans to use the initial proceeds and, if exercised, subsequent proceeds from the financing for the ongoing clinical development of tilsotolimod, its potential NDA filing and commercial launch, and for general corporate purposes.

    The shares of common stock (or common stock equivalents) and warrants sold in the private placement have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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 (Type-I IFN, antigen presentation) and adaptive (T cells) 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 inhibitors. For more information on tilsotolimod trials, please visit www.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 Tranche 2, the use of proceeds, 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: factors affecting Tranche 2 closing, 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 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; and such other important factors as are set forth under the caption "Risk factors" in the Company's filings with the 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.

    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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  3. EXTON, Pa., June 02, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA, the "Company")) today announced preliminary data from the first 10 patients in the safety cohort of  ILLUMINATE-206, a Phase 2, open-label, multi-center study to evaluate tilsotolimod in combination with Opdivo® (nivolumab) and Yervoy®* (ipilimumab) in immunotherapy-naive micro-satellite stable colorectal cancer (MSS-CRC) patients. Based on data to date, the Company plans to expand the study to further evaluate this triplet combination in MSS-CRC.

    To investigate the safety profile of this triplet combination, ILLUMINATE-206 was designed with a stepwise approach to Yervoy® dosage. Patients in this initial safety cohort of the study, many of whom were heavily…

    EXTON, Pa., June 02, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA, the "Company")) today announced preliminary data from the first 10 patients in the safety cohort of  ILLUMINATE-206, a Phase 2, open-label, multi-center study to evaluate tilsotolimod in combination with Opdivo® (nivolumab) and Yervoy®* (ipilimumab) in immunotherapy-naive micro-satellite stable colorectal cancer (MSS-CRC) patients. Based on data to date, the Company plans to expand the study to further evaluate this triplet combination in MSS-CRC.

    To investigate the safety profile of this triplet combination, ILLUMINATE-206 was designed with a stepwise approach to Yervoy® dosage. Patients in this initial safety cohort of the study, many of whom were heavily pre-treated and rapidly progressing, received 8 mg of intratumoral tilsotolimod and 3 mg/kg of intravenous (IV) Opdivo® every 2 weeks, along with 1 mg/kg of IV Yervoy® every 8 weeks. This regimen was generally well tolerated; no patients discontinued treatment due to adverse events (AEs) and none experienced Grade 4 or 5 AEs. One patient experienced stable disease per RECIST v1.1 criteria, and 9 patients progressed as defined by RECIST v1.1. Investigators reported that 6 of the progressing patients had stability or reduction in size of injected lesions and 6 had stability or reduction in overall size of uninjected lesions.

    Based on these results, the Company plans to enroll additional patients in this MSS-CRC cohort of ILLUMINATE-206. Planned changes in the study design intended to improve potential outcomes in this patient population include increasing the frequency of Yervoy® dosing and limiting the number of allowed prior lines of treatment to two or fewer. 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. Pending data from those patients, the trial may be expanded further.

    "We are encouraged by the initial safety profile of this first-time triplet combination," stated Elizabeth A. Tarka, M.D., Idera's Chief Medical Officer. "We look forward to continuing to explore the potential clinical benefit of tilsotolimod in combination with ipilimumab and nivolumab in MSS-CRC, possibly yielding a treatment alternative for these patients with few current options."

    For more information about ILLUMINATE-206, visit www.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 (Type-I IFN, antigen presentation) and adaptive (T cells) 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 received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of anti-PD-1 refractory melanoma, in combination with ipilimumab, as well as Orphan Drug Designation for the treatment of stage IIb-IV melanoma. It is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors. For more information on tilsotolimod trials, please visit www.ClinicalTrials.gov.

    About MSS-CRC
    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, and a prior trial of Yervoy® plus Opdivo® (Bristol Myer Squibb's CheckMate 142) yielded overall response rates of 0-10%. 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.

    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 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 and clinical trial plans, including enrollment and timing of results, 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; and whether the Company's collaborations will be successful. 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.

    *Opdivo (nivolumab) and Yervoy (ipilimumab) 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
    

    Primary Logo

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  4. EXTON, Pa., May 01, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (NASDAQ:IDRA) today provided notice of a change in the location for its 2020 Annual Meeting of Stockholders (the "Annual Meeting") via the filing of additional proxy materials with the U.S. Securities and Exchange Commission.

    Due to the public health impact of the coronavirus (COVID-19) pandemic and related government actions, and to support the health and well-being of our employees, stockholders, and community, the location of Idera's Annual Meeting has been changed and will be held in a virtual meeting format only. You will not be able to attend the Annual Meeting in person.

    Meeting Date: Tuesday, May 12, 2020
    Meeting Time: 9:00 a.m. (Eastern…

    EXTON, Pa., May 01, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (NASDAQ:IDRA) today provided notice of a change in the location for its 2020 Annual Meeting of Stockholders (the "Annual Meeting") via the filing of additional proxy materials with the U.S. Securities and Exchange Commission.

    Due to the public health impact of the coronavirus (COVID-19) pandemic and related government actions, and to support the health and well-being of our employees, stockholders, and community, the location of Idera's Annual Meeting has been changed and will be held in a virtual meeting format only. You will not be able to attend the Annual Meeting in person.

    Meeting Date: Tuesday, May 12, 2020
    Meeting Time: 9:00 a.m. (Eastern Time)
    Conference Call Access: (844) 882-7837 (U.S.) or +1 (574) 990-9824 (international);
                                               Conference Code: 7877966
    Webcast Access: https://edge.media-server.com/mmc/p/8uhpyq28

    The Annual Meeting is open to stockholders who owned shares as of March 24, 2020 (the "Record Date"), proxy holders, and any other interested party that would like to participate as a guest.

    Registered Holders
    Stockholders are encouraged to vote and submit proxies in advance of the Annual Meeting by one of the methods described in the proxy materials for the Annual Meeting. If you were a stockholder as of the close of business on the Record Date, you will have the ability to vote during the Annual Meeting by voice vote after confirming your account number issued by the Company's transfer agent, Computershare. You can obtain your Computershare account number by looking at your most recent communication from Computershare or by calling 1-800-652-VOTE (8683).

    Beneficial Holders
    If you hold your shares through a broker, bank, or other nominee (that is, in "street name"), then your broker, bank, or other nominee is the stockholder of record and such nominee might not be able to vote your shares unless you provide it with voting instructions. You should instruct your broker, bank, or other nominee to vote your shares by following the instructions that your broker, bank, or other nominee provided when it sent the Company's proxy materials to you. You may not vote shares held in street name by returning a proxy card directly to the Company or via the conference call unless you provide the Company with a "legal proxy," which you must obtain from your broker, bank, or other nominee. If you obtain a legal proxy and plan to vote at the Annual Meeting via conference call, then the Company must receive your legal proxy by 5:00 p.m., Eastern Time, on May 11, 2020. You will receive an e-mail from the Company confirming your registration to vote at the Annual Meeting. Legal proxies may be submitted by mail to: Corporate Secretary, Idera Pharmaceuticals, Inc., 505 Eagleview Boulevard, Suite 212, Exton, Pennsylvania 19341; or by e-mail to .

    If you do not have a valid Computershare account number or legal proxy, you will still be able to attend the virtual meeting as a guest; however, you will not have the option to vote your shares during the virtual meeting or ask questions at the virtual meeting. 

    As noted above, all stockholders are encouraged to vote and submit proxies in advance of the Annual Meeting by one of the methods described in the proxy materials for the Annual Meeting, even if you plan to attend the virtual meeting. Please note that the proxy card included with the proxy materials previously distributed may continue to be used to vote your shares in connection with the Annual Meeting. This proxy card will not be updated to reflect the change in location.

    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.

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

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  5. EXTON, Pa., April 30, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (NASDAQ:IDRA) today reported its financial and operational results for the first quarter ended March 31, 2020.

    "I'm proud of what Idera has accomplished since the beginning of the year, despite the worldwide impact of the COVID-19 pandemic. We have completed and reported encouraging data from ILLUMINATE-204, secured additional financing to help execute our key objectives, and, to date, are on track with timelines for both ILLUMINATE-301 and ILLUMINATE-206," stated Vincent Milano, Idera's Chief Executive Officer. "The level of dedication and determination from our employees, our partners, and our investigators is incredibly inspiring."

    EXTON, Pa., April 30, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (NASDAQ:IDRA) today reported its financial and operational results for the first quarter ended March 31, 2020.

    "I'm proud of what Idera has accomplished since the beginning of the year, despite the worldwide impact of the COVID-19 pandemic. We have completed and reported encouraging data from ILLUMINATE-204, secured additional financing to help execute our key objectives, and, to date, are on track with timelines for both ILLUMINATE-301 and ILLUMINATE-206," stated Vincent Milano, Idera's Chief Executive Officer. "The level of dedication and determination from our employees, our partners, and our investigators is incredibly inspiring."

    Corporate Update

    Since December 31, 2019, the Company entered into a private placement financing of up to $20.7 million, with $5 million received in April 2020. The Company anticipates that its current cash, cash equivalents, and short-term investments will fund our operations into the second quarter of 2021. 



    ILLUMINATE (tilsotolimod) Clinical Development Updates

    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.
      • Median overall survival (OS) was 21.0 months (95% confidence interval (CI): 9.8 months-not reached (NR));
      • The overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) was 22.4%, including 2 complete responses (95% CI: 11.8-36.6%);
      • The disease control rate (stable disease or better) was 71.4% (95% CI: 56.7%-83.4%);
      • Median duration of response was 11.4 months (95% CI: 3.3 months-NR); and
      • The combination regimen was generally well tolerated.
    • Final data from the trial to be submitted for presentation at a medical conference in the second half of 2020.

    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) per 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 cohort of 10 patients with MSS-CRC fully enrolled; and
    • Preliminary data from this cohort expected in the second quarter of 2020.

    First Quarter Financial Results

    Research and development expenses for the three months ended March 31, 2020 totaled $9.5 million compared to $8.1 million for the same period in 2019. General and administrative expense for the three months ended March 31, 2020 totaled $3.6 million compared to $3.1 million for the same period in 2019. Additionally, during the three months ended March 31, 2020 we recorded $1.1 million and $20.7 million of non-cash warrant revaluation income and non-cash future tranche right revaluation income, respectively, related to securities issued in connection with our December 2019 private placement transaction.

    As a result of the factors above, net income applicable to common stockholders for the three months ended March 31, 2020 was $8.8 million, or $0.27 per basic share and $0.22 per diluted share, compared to net loss applicable to common stockholders of $11.0 million, or $0.40 per basic and diluted share, for the same period in 2019. Excluding the non-cash income of approximately $21.8 million for the three months ended March 31, 2020 related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $13.0 million, or $0.43 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 March 31, 2020, our cash, cash equivalents, and short-term investments totaled $33.5 million, which includes a $6.2 million contingently refundable option fee received in connection with the December 2019 private placement transaction. Based on our current operating plan, we anticipate that our current cash, cash equivalents, and short-term investments, including the $6.2 million contingently refundable option fee and the $5.0 million gross proceeds in cash received in April 2020 pursuant to the April 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; and whether the Company's collaborations will be successful. 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
      March 31,
       2020   2019 
       
         
    Operating expenses:    
    Research and development  9,510   8,102 
    General and administrative  3,642   3,143 
    Restructuring costs  -   131 
         
    Total operating expenses  13,152   11,376 
         
    Loss from operations  (13,152)  (11,376)
         
    Other income (expense)    
    Warrant revaluation income  1,101   - 
    Future tranche right revaluation income  20,711   - 
    Other income (expense), net  157   402 
         
    Net income (loss) $8,817  $(10,974)
         
    Net income (loss) per common share applicable to common stockholders    
     — basic $0.27  $(0.40)
     — diluted $0.22  $(0.40)
         
    Weighted-average number of common shares used in computing net income (loss) per share applicable to common stockholders    
     — basic  30,300   27,676 
     — diluted  33,010   27,676 
         

    Idera Pharmaceuticals, Inc.

    Balance Sheet Data

    (In thousands)

         
     March 31,  December 31,  
      2020   2019  
         
    Cash, cash equivalents, and short-term investments$33,487  $42,793  
    Other assets 3,579   4,696  
    Total assets$37,066  $47,489  
         
    Total liabilities$37,210  $58,657  
    Total stockholders' equity (deficit) (144)  (11,168) 
    Total liabilities and stockholders' equity (deficit)$37,066  $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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