IDRA Idera Pharmaceuticals Inc.

1.34
-0.01  -1%
Previous Close 1.35
Open 1.33
52 Week Low 1.22
52 Week High 6.14
Market Cap $56,624,991
Shares 42,257,456
Float 34,182,560
Enterprise Value $20,289,690
Volume 5,832,994
Av. Daily Volume 3,467,687
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Upcoming Catalysts

Drug Stage Catalyst Date
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 (IMO-2125) + ipilimumab - ILLUMINATE 301
Melanoma
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - March 18, 2021.
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. CHERRY HILL, N.J., April 05, 2021 (GLOBE NEWSWIRE) -- Vyant Bio, Inc. (the "Company") (NASDAQ:VYNT), is a new force in drug discovery, focused on integrating human-powered scientific and technology-based systems to de-risk and accelerate the discovery of therapeutics for biopharma partners as well as for the proprietary pipeline of the Company. Its newly formed Board of Directors comes from the disciplines of drug discovery and development, pharmaceuticals, and life science strategy and finance. The new board members bring decades of experience and leadership to help guide the Company in its focus on innovative and market leading drug discovery.

    The Company is led in the executive suite by Jay Roberts, Chief Executive Officer, Ping Yeh…

    CHERRY HILL, N.J., April 05, 2021 (GLOBE NEWSWIRE) -- Vyant Bio, Inc. (the "Company") (NASDAQ:VYNT), is a new force in drug discovery, focused on integrating human-powered scientific and technology-based systems to de-risk and accelerate the discovery of therapeutics for biopharma partners as well as for the proprietary pipeline of the Company. Its newly formed Board of Directors comes from the disciplines of drug discovery and development, pharmaceuticals, and life science strategy and finance. The new board members bring decades of experience and leadership to help guide the Company in its focus on innovative and market leading drug discovery.

    The Company is led in the executive suite by Jay Roberts, Chief Executive Officer, Ping Yeh, Chief Innovation Officer and Andy LaFrence, Chief Financial Officer. Joining Mssrs. Roberts and Yeh on the newly formed board are:

    John Fletcher, our Board Chair, bringing over 30 years of strategy and financing experience across the pharmaceutical and healthcare industries to the board. He is the founder and Chief Executive Officer of Fletcher Spaght, Inc., a consulting firm that provides growth-focused strategy assistance to client companies. Since 2001, Mr. Fletcher has also served as the Managing Partner of Fletcher Spaght Ventures, a venture capital fund. Mr. Fletcher is the Chair of Vyant Bio's Board of Directors.

    Joanna Horobin M.B., Ch.B., an accomplished drug developer and biotech leader with over 35 years of experience in the pharmaceutical and biotech sector. Dr. Horobin currently serves as the Chair of the Board of iOnctura SA, a privately-held oncology company and as a Non-Executive Director on the boards of Kymera Therapeutics, Inc.(NASDAQ:KYMR), Nordic Nanovector ASA (Oslo: NANO), and Liquidia Technologies, Inc. (NASDAQ:LQDA). Dr. Horobin has held multiple C-suite roles in biotech companies in the US, most recently as the Chief Medical Officer at Idera Pharmaceuticals, Inc. (NASDAQ:IDRA) and was also the Chief Executive Officer of Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX).

    Marcus F. Boehm, Ph.D. co-founded and is currently Chief Scientific Officer of Escient Pharmaceuticals, Inc. Previously, he was a Co-Founder of Receptos, Inc. where he served as Chief Technology Officer until its acquisition by Celgene Corporation. In 2001, Dr. Boehm was a founding member of Conforma Therapeutics Corporation, which was acquired by Biogen Idec. Dr. Boehm started his industry career with Ligand Pharmaceuticals in 1991 where he held various positions with progressing responsibility.

    Geoffrey Harris is the managing partner of c7 Advisors (a money management and healthcare advisory firm). Prior to that, he served as a managing director and co-head of the healthcare investment banking group at Cantor Fitzgerald, and a similar position at Gleacher & Company. Mr. Harris is also currently on the board of directors of Telemynd, Inc. (formerly known as MYnd Analytics); PointRight Inc., and MoleSafe, Inc.

    Howard McLeod, Pharm.D. is the Medical Director, Precision Medicine for the Geriatric Oncology Consortium and a Professor at the USF Taneja College of Pharmacy. Previously he was Chair of the Department of Individualized Cancer Management and Medical Director of the DeBartolo Family Personalized Medicine Institute at the Moffitt Cancer Center and previously a Senior Member of the Moffitt Cancer Center's Division of Population Sciences. He also chaired the Department of Individualized Cancer Management at Moffitt. Prior to joining the Moffitt Cancer Center, Dr. McLeod was a Founding Director of the University of North Carolina Institute for Pharmacogenomics and Individualized Therapy. Dr. McLeod also held the prestigious title of Fred Eshelman Distinguished Professor at the UNC Eshelman School of Pharmacy.

    Paul Hansen has been a member of the Board of Directors of StemoniX since 2015. Since 2014, Mr. Hansen has served as a Senior Fellow with the University of Minnesota's Technological Leadership Institute. Mr. Hansen is a founder and President of Minnepura Technologies, SBC. Mr. Hansen also held senior executive positions at 3M Company, including President and CEO of 3M Mexico.

    "Each of the individuals selected to join our board is highly qualified and brings a unique perspective based on years of experience guiding innovation and creating tremendous value to shareholders. The board's breadth and depth of knowledge will be an invaluable asset as Vyant Bio embarks on a new era in drug discovery," stated Jay Roberts, Chief Executive Officer of Vyant Bio.

    "I am pleased that we could attract each of our new directors. At this point in Vyant Bio's growth, the distinctive attributes of each of these new board members will provide direction and leadership to guide the Company through its next stage of growth and to achieve its goals," stated Ping Yeh, Chief Innovation Officer of Vyant Bio.

    As a reminder, Jay Roberts, Ping Yeh, and Andy LaFrence will be holding an investor conference call tomorrow, April 6, 2021. Please also visit the Investors' section of the Vyant Bio web site for details on how to participate.

    Event:          Investor Webcast – Announcement of Vyant Bio

    Date:            Tuesday, April 6, 2021

    Time:            4:30pm ET

    Webcast:      https://edge.media-server.com/mmc/p/sxogu3xt

    Dial In:         (844) 954-2324 Conference ID: 9757240

    A live and archived webcast of the conference call will also be available inside the Investors section of the Vyant Bio corporate website at www.vyantbio.com.

    ABOUT VYANT BIO, INC.

    Vyant Bio operates two wholly-owned subsidiaries, StemoniX and vivoPharm. The Company will immediately begin to execute on the integration of these two leading businesses, to converge human-powered scientific and technology-based systems and expertise with years of preclinical experience to de-risk and accelerate discovery and development of preclinical and clinical pipelines for biopharma partners as well as for the proprietary pipeline of the Company.

    StemoniX is empowering the discovery of new medicines through the convergence of novel human biology and software technologies. StemoniX develops and manufactures high-density, at-scale human induced pluripotent stem (iPS) cell-derived neural and cardiac screening platforms for drug discovery and development. Predictive, accurate, and consistent, these human models enable scientists to quickly and economically conduct research with improved outcomes in a simplified workflow. Through collaborations with drug discovery organizations, StemoniX tests compounds in-house, creates new cell-based disease models, and operationalizes custom human iPSC-derived disease models at large scale for high-throughput screening. With leading-edge iPSC technologies and data science, StemoniX is helping global institutions bring the most promising medicines to patients.

    vivoPharm offers proprietary preclinical test systems supporting clinical diagnostic offerings at early stages valued by the pharmaceutical industry, biotechnology companies, and academic research centers. vivoPharm is focused on precision and translational medicine to drive drug discovery and novel therapies. vivoPharm specializes in conducting studies tailored to guide drug development, starting from compound libraries and ending with a comprehensive set of in vitro and in vivo data and reports, as needed for Investigational New Drug filings. vivoPharm operates in The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accredited and GLP compliant audited facilities.

    For more information, please visit or follow Vyant Bio at:

    Internet: www.vyantbio.com

    LinkedIn: https://www.linkedin.com/company/vyant-bio

    Twitter: @VyantBio

    Forward Looking Statements:

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to Vyant Bio, Inc.'s (formerly Cancer Genetics, Inc.) expectations regarding future financial and/or operating results, and potential for our services, future revenues or growth, in this press release constitute forward-looking statements.

    Any statements that are not historical fact (including, but not limited to, statements that contain words such as "will," "believes," "plans," "anticipates," "expects," and "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in our attempts to adapt to the global coronavirus pandemic, achieve profitability and increase sales of our pre-clinical services, maintain our existing customer base and avoid cancelation of customer contracts or discontinuance of trials, raise capital to meet our liquidity needs, realize the anticipated benefits of the merger with StemoniX, Inc., and other risks discussed in the Vyant Bio, Inc. Form 10-K for the year ended December 31, 2020, along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Vyant Bio disclaims any obligation to update these forward-looking statements.

    Investor Contacts:

    Jennifer K. Zimmons. Ph.D.

    Investor Relations

    Zimmons International Communications, Inc.

    Email:

    Phone: +1.917.214.3514

    Source: Vyant Bio, Inc.

    ###



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  2. EXTON, Pa., March 18, 2021 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA, the "Company"))) today is announcing that ILLUMINATE-301, the Company's pivotal registration trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma, did not meet its primary endpoint of objective response rate (ORR). Idera is evaluating its next steps regarding continuation of the trial toward its overall survival (OS) endpoint, which includes evaluating the full data set when it is available. The Company also plans to continue its ILLUMINATE-206 Phase 2 study of tilsotolimod in combination with ipilimumab and nivolumab in patients with microsatellite stable colorectal cancer…

    EXTON, Pa., March 18, 2021 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA, the "Company"))) today is announcing that ILLUMINATE-301, the Company's pivotal registration trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma, did not meet its primary endpoint of objective response rate (ORR). Idera is evaluating its next steps regarding continuation of the trial toward its overall survival (OS) endpoint, which includes evaluating the full data set when it is available. The Company also plans to continue its ILLUMINATE-206 Phase 2 study of tilsotolimod in combination with ipilimumab and nivolumab in patients with microsatellite stable colorectal cancer (MSS-CRC).

    ILLUMINATE-301 is a randomized, global, multi-center, open label Phase 3 trial comparing the efficacy of 8 mg intratumoral tilsotolimod in combination with 3 mg/kg ipilimumab versus 3 mg/kg ipilimumab alone in 481 patients with anti-PD-1 refractory advanced melanoma. The trial has a primary endpoint family of ORR per RECIST v1.1 and OS. Although the primary endpoint of ORR was not met, if the study continues and reaches a positive OS outcome, the Company would expect to discuss with regulatory authorities a potential path forward in this indication.

    ILLUMINATE-301 Key Findings:

    Patients in the study were randomized and treated either with 8 mg of tilsotolimod in combination with ipilimumab or with ipilimumab alone. Topline results include:

    • ORR of 8.8% for the combination arm and 8.6% for ipilimumab alone.
    • Disease control rate (DCR, defined as stable disease or better) of 34.5% for the combination and 27.2% for ipilimumab alone.
    • Treatment-emergent adverse events (TEAEs) (Grade 3 and above) occurred in 61.1% of patients who received the combination vs. 55.1% of patients who received ipilimumab alone. Immune-related TEAEs (Grade 3 and above) were reported in 37.6% vs. 30.1%, respectively.

    More detailed results from ILLUMINATE-301 may be submitted for future publication or presentation.

    "We are surprised and disappointed that the response data from ILLUMINATE-301 do not lead us to an accelerated path to a new and much-needed treatment option for these patients," stated Vincent Milano, Idera's Chief Executive Officer. "We would like to extend our deepest gratitude to everyone involved in this study, especially the many courageous patients who participated and continue in follow up."

    Continued Mr. Milano, "Despite today's news, we are continuing to explore tilsotolimod via our ongoing ILLUMINATE-206 study in order to understand its potential to lead to better outcomes for patients with MSS-CRC."

    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 checkpoint inhibitors (CPIs) than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may 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 Anti-PD-1 Refractory Advanced Melanoma

    Melanoma is a cancer that begins in a type of skin cell called melanocytes. While melanoma is the least common type of skin cancer, it has a poor prognosis when not detected and treated early. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread, or metastasized, beyond the skin to other parts of the body. According to the American Cancer Society, approximately 100,000 people in the US will be diagnosed with invasive melanoma this year. In recent years, immunotherapies known as CPIs have changed the treatment of advanced melanoma, with anti-PD-1 agents, alone or in combination with anti-CTLA-4, being the most commonly used immunotherapy in the first-line setting. These agents work by increasing the ability of the body's immune system to help detect and fight cancer cells. However, due to primary or acquired resistance mechanisms that exclude or inhibit anti-tumor immune cells, as many as 60% of patients may not benefit from this type of therapy when used as monotherapy, and up to one-third of initial responders may develop resistance to the therapy and ultimately experience disease progression. Today, these refractory patients are left with few options for further treatment, paving the way for novel investigational therapies such as tilsotolimod.

    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." The American Cancer Society estimates that, annually in the United States, approximately 140,000 people are diagnosed with CRC, of which 85% are MSS, and approximately 50,000 people die due to CRC. MSS-CRC has been shown to be highly immunosuppressive; there are no approved immunotherapy options, and a prior trial of ipilimumab plus nivolumab (Bristol Myers Squibb's CheckMate 142) yielded overall response rates of 0-10%. Given tilsotolimod's mechanism of action of activating dendritic cells and therefore triggering innate and adaptive immune responses, it may serve a complementary function to ipilimumab and nivolumab 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 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 and related endpoints, 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 further development of the Company's programs for the period anticipated; whether topline results from a clinical trial, such as the 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, 2020 and in the Company's other filings with the Securities and Exchange Commission. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.



    Idera Pharmaceuticals 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., March 01, 2021 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (NASDAQ:IDRA) today reported its financial and operational results for the fourth quarter and year ended December 31, 2020.

    "Tilsotolimod is the most advanced TLR-9 agonist therapy in development, and we are eagerly anticipating objective response rate and other important data from ILLUMINATE-301, our pivotal registration trial in anti-PD-1 refractory advanced melanoma, later this month," stated Vincent Milano, Idera's Chief Executive Officer. "I'm very proud of our team's resiliency and tenacity as they work diligently toward that goal, as well as the ongoing work in ILLUMINATE-206, our trial in micro-satellite stable colorectal cancer…

    EXTON, Pa., March 01, 2021 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (NASDAQ:IDRA) today reported its financial and operational results for the fourth quarter and year ended December 31, 2020.

    "Tilsotolimod is the most advanced TLR-9 agonist therapy in development, and we are eagerly anticipating objective response rate and other important data from ILLUMINATE-301, our pivotal registration trial in anti-PD-1 refractory advanced melanoma, later this month," stated Vincent Milano, Idera's Chief Executive Officer. "I'm very proud of our team's resiliency and tenacity as they work diligently toward that goal, as well as the ongoing work in ILLUMINATE-206, our trial in micro-satellite stable colorectal cancer. In addition, we are in a healthy financial position and expect our current cash to fund our activities into the second quarter of 2022, with the potential of additional capital from our existing security purchase agreements to extend our runway into the second quarter of 2023. These resources will be instrumental in helping us advance tilsotolimod for patients in need."

    Corporate Update

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

    • The Company closed a second tranche under its April 7, 2020 securities purchase agreement for additional aggregate gross proceeds of $5.0 million. With this tranche, the Company has received $25.2 million in proceeds from three financings since December 2019, with anticipated further proceeds of up to $113.2 million to fund the potential NDA filing and commercial launch of tilsotolimod.
    • The Company appointed Daniel Soland as Senior Vice President and Chief Operating Officer as of January 4, 2021. Mr. Soland is responsible for the Company's commercial strategy and manufacturing.
    • R. Clayton Fletcher, Senior Vice President of Business Development and Strategic Planning, retired from the Company as of December 31, 2020. Mr. Fletcher remains engaged with the Company as a consultant, continuing to lead its business development activities.

    ILLUMINATE (tilsotolimod) Clinical Development Updates



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

    • Primary endpoint family of objective response rate (ORR) by blinded independent central review using RECIST v1.1 and overall survival (OS);
    • Trial initiated in March 2019;
    • 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 ipilimumab and 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 ipilimumab at 1 mg/kg every 8 weeks and nivolumab 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 ipilimumab 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 third quarter of 2021.

    Fourth Quarter Financial Results

    Research and development expenses for the three months ended December 31, 2020 totaled $5.1 million compared to $8.4 million for the same period in 2019. General and administrative expense for the three months ended December 31, 2020 totaled $2.9 million compared to $3.4 million for the same period in 2019. Additionally, during the three months ended December 31, 2020 and 2019, we recorded a $3.2 million and $0.6 million non-cash warrant revaluation loss, respectively, and a $65.4 million and $11.0 million 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 December 31, 2020 was $76.7 million, or $2.11 per basic and diluted share, compared to net loss applicable to common stockholders of $51.3 million, or $1.76 per basic and diluted share, for the same period in 2019. Excluding non-cash loss of approximately $68.6 million and $11.6 million for the three months ended December 31, 2020 and 2019, respectively, and deemed dividends of approximately $28.0 million for the three months ended December 31, 2019, all 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 $0.22 per basic and diluted share, and $11.7 million, or $0.40 per basic and diluted share, respectively (calculated based upon the basic weighted-average number of common shares, due to the antidilutive effect of net loss).



    Full Year Results

    Research and development expenses for the year ended December 31, 2020 totaled $24.8 million compared to $34.9 million for the same period in 2019. General and administrative expenses for the year ended December 31, 2020 totaled $11.9 million compared to $12.5 million for the same period in 2019. Additionally, for the year ended December 31, 2020 and 2019, we recorded a $3.7 million and $72.4 million of non-cash warrant revaluation loss, respectively, and a $0.6 million and $11.0 million non-cash future tranche right revaluation loss, respectively, as well as non-cash deemed dividends of approximately $28.0 million during the year ended December 31, 2019, increasing net loss attributable to common stockholders, as further discussed above under fourth quarter results.

    As a result of the factors above, net loss applicable to common stockholders for the year ended December 31, 2020 was $112.7 million or $3.33 per basic and diluted share, compared to net loss applicable to common stockholders of $84.6 million, or $2.96 per basic and diluted share, for the same period in 2019. Excluding non-cash loss of approximately $76.1 million and $11.6 million for the years ended December 31, 2020 and 2019, respectively, and deemed dividends of approximately $28.0 million for the year ended December 31, 2019, all related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $36.6 million, or $1.08 per basic and diluted share, and $45.0 million, or $1.57 per basic and diluted share, respectively (calculated based upon the basic weighted-average number of common shares, due to the antidilutive effect of net loss).

    As of December 31, 2020, our cash, cash equivalents, and short-term investments totaled $37.7 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 2022.

    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, 2020, 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.



    Idera Pharmaceuticals, Inc.

    Statements of Operations

    (In thousands, except per share data)

      Three Months Ended  Twelve Months Ended
      December 31, December 31,
       2020   2019   2020   2019 
        
    Alliance revenue $-  $-  $-  $1,448 
    Operating expenses:        
    Research and development  5,117   8,368   24,772   34,853 
    General and administrative  2,923   3,420   11,915   12,481 
    Restructuring costs  -   -   -   181 
    Total operating expenses  8,040   11,788   36,687   47,515 
    Loss from operations  (8,040)  (11,788)  (36,687)  (46,067)
    Other income (expense)        
    Warrant revaluation loss  (3,247)  (598)  (3,742)  (598)
    Future tranche right revaluation loss  (65,379)  (10,964)  (72,367)  (10,964)
    Other income (expense), net  (35)  118   134   1,114 
    Net loss $(76,701) $(23,232) $(112,662) $(56,515)
    Deemed dividend related to December 2019 Private Placement  -   (28,043)  -   (28,043)
    Net loss attributable to common stockholders $(76,701) $(51,275) $(112,662) $(84,558)
                     
    Net loss per common share applicable to common stockholders basic and diluted $(2.11) $(1.76) $(3.33) $(2.96)
                     
    Weighted-average number of common shares used in computing net loss per share applicable to common stockholders basic and diluted  36,271   29,177   33,821   28,545 
             



    Idera Pharmaceuticals, Inc.

    Balance Sheet Data

    (In thousands)

        
     December 31,  December 31,
      2020   2019 
        
    Cash, cash equivalents and short-term investments$37,728  $42,793 
    Other assets 4,671   4,696 
    Total assets$42,399  $47,489 
        
    Total liabilities$133,571  $58,657 
    Total stockholders' deficit (91,172)  (11,168)
    Total liabilities and stockholders' deficit$42,399  $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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  4. EXTON, Pa., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA) today announced that it will provide a company outlook for 2021 at upcoming conferences.

    "2021 represents a pivotal inflection point for Idera, one in which we anticipate that data soon to be available from our ILLUMINATE program will show that tilsotolimod, the most advanced TLR9 agonist therapy in development, can offer meaningful alternatives to patients suffering from advanced anti-PD-1 refractory melanoma and, potentially, colorectal cancer," stated Vincent Milano, Idera's Chief Executive Officer. "We're looking forward to sharing topline response data from ILLUMINATE-301 late in this quarter and a data update from ILLUMINATE-206 in the third quarter…

    EXTON, Pa., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA) today announced that it will provide a company outlook for 2021 at upcoming conferences.

    "2021 represents a pivotal inflection point for Idera, one in which we anticipate that data soon to be available from our ILLUMINATE program will show that tilsotolimod, the most advanced TLR9 agonist therapy in development, can offer meaningful alternatives to patients suffering from advanced anti-PD-1 refractory melanoma and, potentially, colorectal cancer," stated Vincent Milano, Idera's Chief Executive Officer. "We're looking forward to sharing topline response data from ILLUMINATE-301 late in this quarter and a data update from ILLUMINATE-206 in the third quarter of the year."

    Continued Mr. Milano, "Our entire team is driven by our goal of making a difference for patients and is unified in its persistence to help ensure the quality of our clinical results, NDA and commercial readiness, and a strong financial outlook that includes existing cash that is expected to take us into the first quarter of 2022. We have confidence that this is the year Idera will deliver on its long history of innovative science and begin to turn that history into a business reality."

    The Company plans to share further corporate and ILLUMINATE program updates at the following conferences in January:

    • 39th Annual J.P. Morgan Healthcare Conference, January 11-14, 2021

      Presentation on January 13, 2021, 3:40 pm EST

    • H.C. Wainwright BioConnect 2021 Conference, January 11-14, 2021

      Pre-recorded conversation available January 11, 2021, 6:00 am EST

    Live and archived webcasts of the investor conference presentations will be available in the Investor Relations section of the Idera website.

    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 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 Annual Report filed on Form 10-K for the period ended December 31, 2019 and the Company's Quarterly Report filed on Form 10-Q for the period ended September 30, 2020. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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



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  5. EXTON, Pa., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA) today announced the closing of a second tranche under its April 7, 2020, securities purchase agreement (the "Purchase Agreement"), resulting in aggregate proceeds of up to $20.7 million in common stock and warrant investment by funds affiliated with an institutional investor. Pursuant to the Purchase Agreement, under the second tranche Idera sold 2,747,252 shares of common stock (or common stock equivalents), together with accompanying warrants to purchase 1,373,626 shares of common stock, for aggregate gross proceeds of $5.0 million. The placement is exempt from the registration requirements of the Securities Act of 1933, as amended.  

    "We believe this…

    EXTON, Pa., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA) today announced the closing of a second tranche under its April 7, 2020, securities purchase agreement (the "Purchase Agreement"), resulting in aggregate proceeds of up to $20.7 million in common stock and warrant investment by funds affiliated with an institutional investor. Pursuant to the Purchase Agreement, under the second tranche Idera sold 2,747,252 shares of common stock (or common stock equivalents), together with accompanying warrants to purchase 1,373,626 shares of common stock, for aggregate gross proceeds of $5.0 million. The placement is exempt from the registration requirements of the Securities Act of 1933, as amended.  

    "We believe this funding and other financial arrangements we have in place reflect optimism in the significant commercial opportunity for tilsotolimod, the most advanced TLR9 agonist therapy in development, to address the unmet medical need for patients living with anti-PD-1 refractory advanced melanoma and other difficult to treat tumor types," stated Vincent Milano, Chief Executive Officer of Idera. "It also provides us the potential cash runway to help make tilsotolimod, if approved, available to those patients."

    The Company plans to use the $10.0 million in cash proceeds from the first and second tranches of this private placement to fund the completion of the ongoing ILLUMINATE-301 clinical trial and potential NDA filing of its lead product, tilsotolimod, for the treatment of anti-PD-1 refractory metastatic melanoma, and for general corporate purposes. The Company plans to use the subsequent proceeds of up to $10.7 million, if associated warrants are exercised, to fund the potential commercial launch of tilsotolimod, as well as the ongoing ILLUMINATE-206 trial exploring tilsotolimod in tumor types beyond melanoma and 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 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 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 Annual Report filed on Form 10-K for the period ended December 31, 2019 and the Company's Quarterly Report filed on Form 10-Q for the period ended September 30, 2020. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.



    Idera Pharmaceuticals 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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