IDERA PHARMACEUTICALS, INC. (IDRA) SPO
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|Company Name||IDERA PHARMACEUTICALS, INC.|
|Company Address||505 EAGLEVIEW BOULEVARD
EXTON, PA 19341
|CEO||Vincent J. Milano|
|Employees (as of 2/15/2017)||62|
|State of Inc||DE|
|Fiscal Year End||12/31|
|Shares Over Alloted||0|
|Shareholder Shares Offered||--|
|Lockup Period (days)||180|
|Quiet Period Expiration||12/4/2017|
We estimate that the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, will be approximately $56.2 million, or approximately $64.6 million if the underwriters exercise their option to purchase additional shares from us in full, in each case, based on an assumed public offering price of $2.24 per share, the last reported sale price of our common stock on The Nasdaq Capital Market on October 23, 2017. As of June 30, 2017, we had cash, cash equivalents and investments of approximately $77.2 million. We estimate that we had cash, cash equivalents and investments of approximately $65.3 million as of September 30, 2017. In October 2017 we received additional proceeds of approximately $4.8 million upon the exercise of certain of our outstanding warrants. Our estimate of our cash, cash equivalents and investments as of September 30, 2017 is an estimate prepared by management in good faith based upon internal reporting and expectations as of and for the three months ended September 30, 2017. This estimate is preliminary, and unaudited, and may be revised as a result of management's further review of our results. We and our auditors have not completed the normal quarterly review procedures as of and for the period ended September 30, 2017, and there can be no assurance that our final results for this quarterly period will not differ from this estimate. We intend to use the net proceeds to us from this offering, together with our existing cash, cash equivalents and investments, to advance the development of IMO-2125 in our immuno-oncology program and for working capital and other general corporate purposes. We expect we will need to raise additional funds in order to complete the ongoing Phase 1/2 trial of IMO-2125 and the planned Phase 3 trial of IMO-2125, to conduct further clinical development of IMO-8400 beyond completing our ongoing Phase 2 clinical trial of IMO-8400 in patients with dermatomyositis, or to conduct any clinical development of IDRA-008 beyond submission of an IND and the completion of a Phase 1 human clinical proof-of-concept trial of IDRA-008. This expected use of net proceeds represents our intentions based upon our current plans and business conditions. Our actual expenditures may vary significantly depending on a number of factors, including the status of and results from nonclinical and clinical trials of our drug candidates and the clinical trials that regulatory authorities require us to perform in order to obtain market approval. As of the date of this prospectus supplement, we cannot specify with certainty all of the particular uses for the net proceeds to us from this offering. Accordingly, our management will have broad discretion in the application of these proceeds. Pending use of the net proceeds as described above, we intend to invest the proceeds in short- and long-term, interest-bearing, investment grade securities.
We are developing our TLR-targeted drug candidates for use in our immuno-oncology program and in the treatment of certain rare diseases. Through our clinical alliance partner MD Anderson, we also initiated a Phase 1/2 clinical trial of IMO-2125, administered intra-tumorally, in combination with ipilimumab, a CTLA4 antibody, in patients with metastatic melanoma in the fourth quarter of 2015. We also initiated a Phase 2 clinical trial of IMO-8400 in patients with dermatomyositis in the fourth quarter of 2015. We also entered into a collaborative alliance agreement with GSK and expect to continue to seek to enter into additional collaborative alliances with pharmaceutical companies with respect to applications of our 3GA technology program. For all of these disease areas, there are many other companies, public and private, that are actively engaged in discovery, development, and commercializing products and technologies that may compete with our drug candidates and programs, including TLR-targeted compounds as well as non-TLR-targeted therapeutics. We are aware of other companies including Dynavax, Mologen AG, BioLineRx Ltd., Innate Immunotherapeutics Ltd., VentiRx Pharmaceuticals Inc., Telormedix S.A., Gilead Sciences Inc., GlaxoSmithKline plc, AstraZeneca plc, Checkmate Pharmaceuticals, Inc. and Hoffmann-La Roche that are developing TLR agonists and antagonists for various indications, including oncology and rare diseases. Application of TLR Agonists in Immuno-Oncology Immuno-oncology, which utilizes a patient’s own immune system to combat cancer, is currently an active area of research for biotechnology and pharmaceutical companies. Interest in immuno-oncology is driven by efficacy data in cancers with historically bleak outcomes and the potential to achieve a cure or functional cure for some patients. As such, we expect that our efforts in this field will be competitive with a wide variety of different approaches. Any one of these competitive approaches may result in the development of novel technologies that are more effective, safer or less costly than any that we are developing. In addition, Dynavax is conducting a Phase 1/2 clinical trial of an investigational TLR9 agonist in combination with checkpoint inhibitors. IMO-8400 Development Program for Dermatomyositis Many of the drug development programs in dermatomyositis are focusing on expanding the use of drugs approved in different indications through investigator sponsored studies such as the ongoing studies of the monoclonal antibodies, belimumab and tocilizumab. In addition, Novartis is developing a competitive anti-inflammatory approach with its new investigational drug, BAF312, a sphingosine-1-phosphate receptor modulator aimed at inhibiting the migration of lymphocytes to the location of inflammation. We are not aware of other new chemical or molecular entities being developed for the treatment of dermatomyositis. Third-generation Antisense (3GA) Technology to Target RNA We are developing 3GA drug candidates that we have created using our proprietary technology, to inhibit the production of disease-associated proteins by targeting RNA. We also face competition from other companies working to develop novel drugs using technologies that may compete with our 3GA technology. We are aware of multiple companies that are developing technologies that use oligonucleotide-based compounds to inhibit the production of disease associated proteins. These technologies include, but are not limited to, antisense technology as well as RNAi. In the field of antisense technologies, we compete with multiple companies, including Ionis and its partners, as well as WAVE Life Sciences and its partner. Ionis is currently marketing an antisense drug, Kynamro, and Biogen recently received FDA approval for its antisense drug Spinraza for spinal muscular atrophy. Ionis has over two dozen antisense drug candidates in clinical trials. In the field of RNAi, we compete with Alnylam, Dicerna, Miragen, and their respective partners. For example, Alnylam is developing multiple RNAi-based technologies and has six drug candidates in clinical trials. Any of the competing companies may develop gene-silencing technologies more rapidly and more effectively than us, and antisense technology and RNAi may become the preferred technology for drugs that target RNA in order to inhibit the production of disease-associated proteins. Some of these potentially competitive products have been in development or commercialized for years, in some cases by large, well established pharmaceutical companies. Many of the marketed products have been accepted by the medical community, patients, and third-party payors. Our ability to compete may be affected by the previous adoption of such products by the medical community, patients, and third-party payors. Additionally, in some instances, insurers and other third-party payors seek to encourage the use of generic products, which makes branded products, such as is planned for our drug candidates upon commercialization, potentially less attractive, from a cost perspective, to buyers. We recognize that other companies, including large pharmaceutical companies, may be developing or have plans to develop products and technologies that may compete with ours. Many of our competitors have substantially greater financial, technical, and human resources than we have. In addition, many of our competitors have significantly greater experience than we have in undertaking preclinical studies and human clinical trials of new pharmaceutical products, obtaining FDA and other regulatory approvals of products for use in health care and manufacturing, and marketing and selling approved products. Our competitors may discover, develop or commercialize products or other novel technologies that are more effective, safer or less costly than any that we are developing. Our competitors may also obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours. We anticipate that the competition with our drug candidates and technologies will be based on a number of factors including product efficacy, safety, availability, and price. The timing of market introduction of our drug candidates and competitive products will also affect competition among products. We expect the relative speed with which we can develop products, complete the clinical trials and approval processes, and supply commercial quantities of the products to the market to be important competitive factors. Our competitive position will also depend upon our ability to attract and retain qualified personnel, to obtain patent protection or otherwise develop proprietary products or processes, protect our intellectual property, and to secure sufficient capital resources for the period between technological conception and commercial sales.
We are a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel oligonucleotide therapeutics for oncology and rare diseases. We use two distinct proprietary drug discovery technology platforms to design and develop drug candidates: our
Toll-like receptor, or TLR, targeting technology and our third-generation antisense, or 3GA, technology. We developed these platforms based on our scientific expertise and pioneering work with synthetic oligonucleotides as therapeutic agents. Using our TLR targeting technology, we design synthetic oligonucleotide-based drug candidates to modulate the activity of specific TLRs. In addition, using our 3GA technology, we are developing drug candidates to turn off the messenger RNA, or mRNA, associated with disease causing genes. We believe our 3GA technology may potentially reduce the immunotoxicity and increase the potency of earlier generation antisense and RNA interference, or RNAi, technologies. Our business strategy is focused on the clinical development of drug candidates for oncology and rare diseases characterized by small, well-defined patient populations with serious unmet medical needs. We believe we can develop and commercialize these targeted therapies on our own. To the extent we seek to develop drug candidates for broader disease indications, we have entered into and may explore additional collaborative alliances to support development and commercialization. The following table summarizes certain information regarding our drug candidates and development programs. Research and development programs Drug candidate(s) Indication / Application Development status Programs for the Modulation of Specific Toll-like Receptors Immuno-oncology IMO-2125 Anti-PD1 Refractory Phase 1/2 clinical trial Metastatic Melanoma in combination with ipilimumab and pembrolizumab. Anticipated completion of enrollment in ipilimumab combination arm of the Phase 2 portion of the trial by the end of 2018. Anticipated initiation of planned Phase 3 trial (IMO-2125-ipilimumab combination) in the first quarter of 2018. Refractory Solid Tumors Phase 1 monotherapy trial in multiple tumor types ongoing. Phase 2 trial in combination with various checkpoint inhibitors in multiple tumor types—Anticipated initiation in the second half of 2018. Rare Diseases IMO-8400 Dermatomyositis Phase 2 clinical trial—Enrollment complete. Data anticipated to be available in the first half of 2018. Third-generation Antisense IDRA-008 Undisclosed Liver Target Research / IND-enabling for Rare Disorder activities underway—Anticipated IND submission in the first half 2018. 3GA Compound Renal Target Collaboration with GSK for undisclosed renal targets entered into in 2015. Single candidate selection by GSK for the selected target anticipated in the second half of 2018. IMO-9200 Non-malignant Exclusive license and Gastrointestinal collaboration agreement Disorders with Vivelix entered into in 2016. --- Our principal executive offices are located at 167 Sidney Street, Cambridge, Massachusetts 02139 and 505 Eagleview Boulevard, Suite 212, Exton, Pennsylvania 19341, and our telephone number is (617) 679-5500. Our website: www.iderapharma.com.
|Auditor||Ernst & Young LLP|
|Company Counsel||Wilmer Cutler Pickering Hale and Dorr LLP|
|Lead Underwriter||Barclays Capital Inc|
|Lead Underwriter||Goldman Sachs & Co. LLC|
|Lead Underwriter||J.P. Morgan Securities LLC|
|Transfer Agent||Computershare Trust Company, N.A|
|Underwriter Counsel||Ropes & Gray LLP|
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