On September 30, 2016 MagForce AG (Frankfurt, Entry Standard, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, reported its financial results for the first half of 2016, ending on June 30, 2016, and operative highlights (Press release, MagForce, OCT 30, 2016, View Source [SID:SID1234515523]).

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Operative Highlights:

Brain Cancer NanoTherm(TM) Therapy at MagForce AG

In Europe, MagForce AG is continuing to expand the commercialization phase of its valuable NanoTherm(TM) therapy: The first phase was to install NanoActivators(R) in Germany and assist the neurosurgeons and radiologists as they became familiar with NanoTherm(TM) therapy and its applicability. The second phase was to initiate the Company’s commercialization efforts with the goal of increasing patient inquiries to 100 per month. The combination of clinical success and marketing efforts will result in the Company achieving the targeted patient inquiry level. MagForce is currently half way there. In the third phase, cross-border reimbursement processes have been optimized based on the fact that a majority of the patients requesting treatment require the implementation of the Cross-Border Directive of the European Union. However, the medical procedure for treating glioblastoma generally requires surgery and radiation resulting in the patient’s obligation to fund the country differential costs for surgery and radiation in his home country and the higher costs for these treatments in Germany, as well as for the NanoTherm(TM) therapy.

During 2016, MagForce has streamlined the implementation of the cross- border reimbursement process, however, due to the aggressiveness of glioblastoma, there is a limited time interval to achieve treatment. Toward that end, the Company will continue its efforts to increase the medical awareness of the value of NanoTherm(TM) therapy to allow earlier patient inquiries.

Phase four of the Commercialization Program will be to obtain domestic reimbursement for NanoTherm(TM) therapy in Germany and selected countries in the EU where MagForce has the CE Mark for the treatment of brain tumors.

As mentioned three months ago, Management is actively exploring financing options, such as third-party leases of NanoActivator(R) equipment, or other non-equity financing options in order to further accelerate MagForce’s expansion in Europe.

Prostate Cancer Therapy at MagForce USA, Inc.

In the USA, MagForce USA, Inc.’s has filed an Investigational Device Exemption (IDE) with the USA Food and Drug Administration (FDA) for NanoTherm(TM) therapy to treat Intermediate Risk Prostate Cancer in 2015. MagForce is still working with the FDA to update preclinical studies, which were conducted approximately ten years ago, to current US regulatory standards and continues making very good progress toward adapting NanoTherm(TM) therapy as a focal treatment for prostate cancer. NanoTherm(TM) therapy for the focal treatment of prostate cancer is viewed as a very promising complement to current treatment approaches. These preclinical studies are underway with interim results clearly supporting the earlier European data.

The purpose of the proposed Focal Thermal Ablation Registration study that will enroll up to 120 men is to demonstrate that NanoTherm(TM) can ablate cancer lesions for patients who have Gleason Score 7 prostate cancer and are under active surveillance. By ablating the lesions, patients will be able to maintain active surveillance and avoid surgery and other treatments with their well-known side effects.

"I am still confident we will achieve our original targets in terms of market entry and commercialization of NanoTherm(TM) therapy in the USA because we clearly have a "time safety factor" built in our business plan, plus we have accelerated the ambulatory prostate NanoActivator(R) chair development to ensure timely delivery of this device. In Europe, our commercial treatment rate is still too slow but the medical results are very gratifying. The experiences we made from our commercialization efforts over the past 18 months pinpointed how to reach our commercialization targets, and we are enforcing the respective implementation. We are on the right path and overall making progress with our brain cancer Commercialization Program in Europe," commented Dr. Ben J. Lipps, CEO of MagForce AG and MagForce USA, Inc. "In summary, I am very optimistic that MagForce will develop and expand our NanoTherm(TM) therapy into a valued therapy for the treatments of brain cancer and prostate cancer and move towards achieving the goals set in the five year target plan. The growing interest in applying NanoTherm(TM) therapy for the treatment of brain tumors and the progress of our work with the FDA are very encouraging. Thus, we are successfully moving forward on our exciting and challenging path."

Financial Results and Outlook:

Results of operations, net assets and financial position

MagForce adopted new revenue reporting rules for periods starting after December 31, 2015. In addition, MagForce reports for the first time Non- GAAP financial measures that are used by MagForce’s management to make operating decisions, as they facilitate internal comparisons of MagForce’s performance to historical results. MagForce’s management believes that Non- GAAP measures provide investors with means of evaluating, and an understanding of how MagForce’s management evaluates, MagForce’s performance and results on a comparable basis that is not otherwise apparent on a German GAAP basis, since many non-recurring, infrequent or non-cash items that MagForce’s management believes to be not indicative of the core performance of the business may not be excluded when preparing financial measures under German GAAP.

These Non-GAAP measures should not be considered in isolation from, as substitutes for, or superior to financial measures prepared in accordance with German GAAP.

Due to the adoption of new revenue reporting rules (sec. 277 para. 1 HGB as amended by BilRuG) for periods starting after December 31, 2015, revenue includes also management recharges to subsidiaries that were included in other operating income in prior years. For additional information we refer to the Notes to the Interim Financial Statements.

Net loss (prior year: profit) for the first half year was EUR 3.2 million (prior year: EUR 0.5 million) while Non-GAAP net loss slightly decreased for the half year by EUR 0.1 million to EUR 2.2 million (prior year: EUR 2.3 million).

Compared to the prior year reporting period personnel expenses increased by EUR 0.2 million to EUR 1.7 million chiefly due to the formation of a new commercial team to accelerate the Company’s efforts to establish NanoTherm(TM) therapy in Germany and the EU. The additional expenses attached to this indispensable staffing were compensated by frugal use of MagForce’s resources in other areas of controllable expense spending.

Revenues and other operating income amounted to EUR 0.7 milllion (prior year: EUR 4.9 million), while Non-GAAP revenue and other operating income increased by EUR 0.1 million to EUR 0.7 million (prior year: EUR 0.6 million). Revenues and other operating income include revenues from commercial treatment of patients with NanoTherm(TM) therapy on a cash basis as well as reimbursement of treatment costs by third parties and recharges to subsidiaries. The Non-GAAP increase chiefly stems from higher personnel recharges to subsidiaries of EUR 0.4 million compared to EUR 0.3 million in the prior year period.

Revenue and other operating income were adjusted to Non-GAAP for the extension of the distribution and development rights for the countries Canada and Mexico in January 2015 amounting to EUR 3.0 million as well as the sale of two NanoActivator(R) devices to MagForce USA, Inc. in the first half year of 2015 in the amount of EUR 1.2 million. Revenue includes also management recharges to subsidiaries that were included in other operating income in prior years.

Cash outflows from operating activities amounted to EUR -3.4 million (prior year: EUR -3.8 million). Cash inflows from investing activities amounted to EUR 3.1 million (prior year: EUR 0.1 million), and cash flows from financing activities amounted to EUR 2.3 million (prior year: EUR nil).

Liquid funds of the Company including cash and cash equivalents of EUR 3.4 million (December 31, 2015: EUR 1.4 million) as well as short term loans of EUR nil (December 31, 2015: EUR 3.1 million) amounted to EUR 3.4 million at the end of the period (December 31, 2015: EUR 4.5 million).

On October 28, 2016 Takeda reported first half FY2016 results and raised full year profit guidance (Press release, Takeda, OCT 28, 2016, View Source [SID1234516092]).

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Strong first half results led by Growth Drivers

Underlying Revenue grew +7.4%, led by a +15.3% increase of Takeda’s Growth Drivers
(GI, Oncology, CNS and Emerging Markets). Reported revenue declined -5.9%, due to unfavorable currencies (-8.6pt) and the impact of divestitures (-4.7pt).
Underlying Core Earnings advanced +12.7% with the Core Earnings margin increasing by 0.7pt. Despite unfavorable currencies and the negative impact of divestitures, reported operating profit was up +46.7% benefiting from strong underlying growth and a one-time gain on the Teva JV transaction.
Underlying Core EPS was up +49.3%, reflecting strong Core Earnings growth and a lower tax rate due to timing. Reported EPS more than doubled to 159 yen, up from 69 yen in the prior year period.
Reported Operating Free Cash Flow was up 34.0% to 74.6 billion yen driven by continued working capital improvements.
Takeda’s Growth Drivers delivered 15.3% Revenue growth

GI underlying revenue grew +39.4%, driven by ENTYVIO and TAKECAB.
Oncology underlying revenue grew +4.9% driven by NINLARO and ADCETRIS.
CNS underlying revenue of +28.2% was boosted by a strong TRINTELLIX performance.
Emerging Markets underlying revenue growth was +4.9% with Q2 growth accelerating to +5.7%.
Underlying Revenue growth across all regions, led by continued double-digit performance in the US

Japan underlying revenue was up +4.1%, driven by TAKECAB, AZILVA and LOTRIGA.
US underlying revenue growth of +15.1%, led by ENTYVIO, NINLARO and TRINTELLIX.
Europe and Canada underlying revenue grew +4.8%, driven by ENTYVIO and ADCETRIS.
Emerging Markets underlying revenue was up +4.9%, with robust growth in the key markets of Brazil (+11.1%), China (+9.7%) and Russia (+8.4%).
Christophe Weber, President and Chief Executive Officer of Takeda, commented:
"Today we reported strong first half results in a year of significant transformation. This strong momentum allows us to increase our full year profit guidance.
The recent positive CHMP opinion for the conditional approval of NINLARO in the EU was an important step to bring this new treatment option to patients worldwide. I am confident that our Growth Drivers will continue to fuel our momentum well into the future."

Reported Results for H1 (April – September) of FY2016
(billion yen) FY2015
H1 FY2016
H1 Growth
Reported Underlying2
Revenue 904.0 850.8 -5.9% +7.4%
Core Earnings1 174.9 131.0 -25.1% +12.7%
Operating Profit 110.4 162.1 +46.7% N/A
Net Profit3 54.4 124.3 +128.6% N/A
EPS 69 yen 159 yen +129.4% N/A
Core EPS 138 yen 139 yen +1.2% +49.3%
1 Core Earnings is calculated by taking reported gross profit and deducting SG&A expenses and R&D expenses.
In addition, certain other items that are non-core in nature and significant in value may also be adjusted.
2 Underlying growth compares two periods of financial results under a common basis, showing the ongoing performance of the business excluding the impact of foreign exchange and divestitures.
3 Attributable to the owners of the company.

Takeda increases management guidance for Underlying Core Earnings to "mid- to high-teen growth" and Underlying Core EPS is trending to the high end of the "low- to mid-teen growth" range

FY2016 Management Guidance
Previous Guidance
(May 10, 2016) Revised Guidance
(Oct 28, 2016)
Underlying Revenue Mid single digit growth (%) Mid single digit growth (%)
Underlying Core Earnings Low- to mid-teen growth (%) Mid- to high-teen growth (%)
Underlying Core EPS Low- to mid-teen growth (%) Low- to mid-teen growth (%)
Annual Dividend per Share 180 yen 180 yen
Reported Net Profit/EPS forecast increased despite accelerated R&D transformation costs and unfavorable currency impact
Total estimated costs related to the R&D transformation program are unchanged at 75 billion yen; with 40 billion yen estimated in FY2016 (previous forecast was 25 billion yen) and 35 billion yen in FY2017.

FY2016 Reported Forecast
(billion yen) Previous Forecast
(May 10, 2016) Revised Forecast
(Oct 28, 2016)
Revenue 1,720.0 1,670.01
R&D Expenses -325.0 -310.02
Operating Profit 135.0 135.0
Net Profit 3 88.0 91.0
EPS 112 yen 116 yen
Exchange Rate (annual average) 1 US$=110 yen, 1 euro=125 yen 1 US$=104 yen, 1 euro=117 yen
1 Includes unfavorable currency impact of approximately 68 billion yen
2 Includes favorable currency impact of approximately 14 billion yen
3 Attributable to the owners of the company

For more details on Takeda’s FY2016 H1 results and other financial information please visit View Source

On October 28, 2016 Nektar Therapeutics (Nasdaq: NKTR) reported five data presentations will be delivered at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, which will be held November 9-13, 2016 at the Gaylord National Hotel and Convention Center in National Harbor, Maryland (Press release, Nektar Therapeutics, OCT 28, 2016, View Source [SID1234516075]). Investigators and researchers will present new clinical and preclinical data on NKTR-214, the Company’s immuno-stimulatory CD122-biased agonist, as well as preclinical data on NKTR-255, the Company’s IL-15 therapeutic candidate.

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Details of the oral clinical data presentation are as follows:

Title: A CD122-biased agonist increases CD8+T Cells and natural killer cells in the tumor microenvironment; making cold tumors hot with NKTR-214
Presenter: Dr. Adi Diab, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Session: New Cancer Immunotherapy Agents in Development
Date: Wednesday, November 9, 2016, 11:10 a.m. – 12:20 p.m. Eastern Time

Details of the poster clinical data presentation are as follows:

Poster 387: A CD122-biased agonist increases CD8+T Cells and natural killer cells in the tumor microenvironment; making cold tumors hot with NKTR-214
Session: Tumor Microenvironment
Date: Friday, November 11, 2016, 12:15 – 1:30 p.m. and 6:15 – 7:30 p.m. Eastern Time

Details of the poster preclinical data presentations are as follows:

Poster 343: Anti-tumor activity of NKTR-214; a CD122-biased agonist that promotes immune cell activation in the tumor microenvironment and lymphoid tissues
Session: Promoting and Measuring Anti-Tumor Activity
Date: Friday, November 11, 2016, 12:15 – 1:30 p.m. and 6:15 – 7:30 p.m. Eastern Time

Poster 359: NKTR-214, an engineered cytokine, synergizes and improves efficacy of anti-cancer vaccination in the treatment of established murine melanoma tumors
Session: Therapeutic Cancer Vaccines
Date: Friday, November 11, 2016, 12:15 – 1:30 p.m. and 6:15 – 7:30 p.m. Eastern Time

Poster 342: NKTR-255: an IL-15-based therapeutic with optimized biological activity and anti-tumor efficacy
Session: Promoting and Measuring Anti-Tumor Activity
Date: Saturday, November 12, 2016, 11:45 a.m. – 1:00 p.m. and 6:45 – 8:00 p.m. Eastern Time

On October 28, 2016 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results and reviewed business highlights for the three-month period ended September 30, 2016 (Press release, ImmunoGen, OCT 28, 2016, View Source [SID1234516070]).

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"During the last quarter, we strengthened our business and better positioned ImmunoGen for long-term growth," said Mark Enyedy, president and chief executive officer of ImmunoGen. "We prioritized our portfolio to focus on initiating Phase 3 development of and generating combination data with mirvetuximab soravtansine, as well as accelerating our earlier-stage IGN programs, IMGN779 and IMGN632. We look forward to starting our registration-enabling trial for mirvetuximab soravtansine before the end of the year and to an oral presentation for IMGN632 at ASH (Free ASH Whitepaper). Together with our strong cash position, the steps we have undertaken as part of our strategic review will enable us to fund our operations through the FORWARD I interim analysis and into mid-2018."

Updates and anticipated events with the Company’s programs include:

Mirvetuximab soravtansine

The Phase 3 FORWARD I trial of mirvetuximab soravtansine in platinum-resistant ovarian cancer is on track to enroll the first patient before the end of the year.
Combination regimens with mirvetuximab soravtansine in ovarian cancer are being evaluated in the Phase 1b/2 FORWARD II trial at sites in the U.S., Canada, and Europe. Dosing was initiated with Keytruda and continued with Doxil in patients with platinum-resistant disease and, separately, with carboplatin in platinum-sensitive patients. Following successful completion of dose escalation, a Phase 2 expansion cohort in combination with Avastin is ongoing. ImmunoGen expects to report initial data from FORWARD II in 2017.
IMGN779 and IMGN632

Preclinical data from the IMGN779 and IMGN632 programs will be presented at the ASH (Free ASH Whitepaper) Annual Meeting in December, which will include an oral presentation for IMGN632.
A Phase 1 trial of CD33-targeting IMGN779 in acute myeloid leukemia (AML) is ongoing with the first clinical data expected to be reported in 2017. IMGN779 is the first ADC with ImmunoGen’s DNA-acting IGN technology to enter clinical testing.
ImmunoGen intends to submit an IND application for and to initiate clinical testing of IMGN632 in 2017. IMGN632 is a CD123-targeting IGN ADC for the treatment of hematological malignancies.
Financial Results

For the Company’s quarter ended September 30, 2016, ImmunoGen reported a net loss of $44.7 million, or $0.51 per basic and diluted share, compared to a net loss of $33.7 million, or $0.39 per basic and diluted share, for the same quarter last year.

Revenues for the quarter ended September 30, 2016 were $7.7 million, compared to $14.9 million for the quarter ended September 30, 2015. License and milestone fees for the prior period include $6 million from partner milestone payments compared to no milestone payments received in the current period. Revenues in the current period include $6.2 million of non-cash royalty revenues, compared with $5.7 million in non-cash royalty revenues for the prior period. Revenues for current period also include $1.4 million of research and development support fees and $46,000 of clinical materials revenue, compared with $0.8 million and $2.3 million, respectively, in the prior period.

Operating expenses for the quarter ended September 30, 2016 were $46.5 million, compared to $43.5 million for the quarter ended September 30, 2015. Operating expenses in the current period include research and development expenses of $32.9 million, compared to $35.1 million in the prior period. This change is primarily due to a decrease in third-party costs resulting from activities performed in the prior period related to developing assays to support pivotal development for mirvetuximab soravtansine and decreased costs associated with manufacturing clinical materials on behalf of our partners, partially offset by increased personnel expenses driven principally by hiring over the prior fiscal year. Operating expenses include general and administrative expenses of $9.5 million in the current period, compared to $8.3 million in the prior period. This increase is primarily due to increased third-party service fees relating to the Company’s strategic review announced on September 29, 2016. Operating expenses in the current period correspondingly include a $4.1 million restructuring charge, which includes costs related to a 17% workforce reduction and a $1 million impairment loss on leasehold improvements related to leased office space that the Company will not occupy and will seek to sublease. An additional $0.3 million charge related to the restructuring is anticipated to be recorded in the quarter ending December 31, 2016 when the Company will begin to realize overall cost reductions related to the restructuring.

ImmunoGen had approximately $196.0 million in cash and cash equivalents as of September 30, 2016, compared with $245.0 million as of June 30, 2016, and had $100.0 million of convertible debt outstanding in each period. Cash used in operations was $48.6 million for the quarter ended September 30, 2016, compared with $31.4 million for the quarter ended September 20, 2015. Capital expenditures were $0.4 million and $3.4 million for the quarter ended September 30, 2016 and 2015, respectively.

Financial Guidance

As previously disclosed, ImmunoGen is transitioning to a fiscal year ending December 31, effective January 1, 2017. ImmunoGen has updated its financial guidance for the six months ending December 31, 2016. Expected revenues are now projected to be between $25 million and $30 million, compared with previous guidance of between $40 million and $45 million; operating expenses are now projected to be between $90 million and $95 million, compared with previous guidance of $95 million and $100 million; the Company’s guidance for its net loss is now expected to be between $70 million and $75 million, compared to its previous estimate of $55 million and $60 million.

ImmunoGen now projects cash and marketable securities at December 31, 2016 to be between $165 million and $170 million, compared to previous guidance of $170 million and $175 million. The Company’s guidance for cash used in operations is now projected to be between $70 million and $75 million, which had previously been between $65 million and $70 million. The Company’s guidance for capital expenditures remains unchanged, which is between $2 million and $5 million.

On October 28, 2016 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel nucleic acid-based therapeutics for oncology and rare diseases, reported its financial and operational results for the third quarter ended September 30, 2016 (Press release, Idera Pharmaceuticals, OCT 28, 2016, View Source;p=RssLanding&cat=news&id=2217080 [SID1234516069]).

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Since June 30, 2016, the Company:

Announced positive clinical data from the initial cohorts of the phase 1 dose escalation portion of the Company’s ongoing Phase 1/2 clinical trial of intratumoral IMO-2125 in combination with ipilimumab in patients with PD-1 refractory metastatic melanoma;
Presented pre-clinical data updates on both novel mechanism of action and selective targeting of single point mutations with 3rd Generation Antisense (3GA) at the Cold Springs Harbor Laboratory Conference on Regulatory & Non-Coding RNAs conference and the Annual Meeting of the Oligonucleotide Therapeutic Society, respectively;
Received acceptance of an abstract entitled "Reactivating the Anti-tumor Immune Response by Targeting Innate and Adaptive Immunity in a Phase I/II Study of intratumoral IMO-2125 in Combination with Systemic Ipilimumab in Patients with Anti-PD-1 Refractory Metastatic Melanoma" for an oral presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2016;
Received acceptance of an oral presentation entitled "IMO-2125, An Investigational intratumoral Toll-Like Receptor 9 Agonist, Modulates the Tumor Microenvironment to Enhance Anti-Tumor Immunity" at SITC (Free SITC Whitepaper) Annual Meeting;
Generated estimated net proceeds of $48.9M, after deducting underwriters’ discounts and commissions and estimated offering expenses, from a public offering of common stock, including from the partial exercise by the underwriters of their option to purchase additional shares in the offering, which option exercise is expected to close today. The Company believes that, based on its current operating plan, its existing cash, cash equivalents and investments, including the net proceeds from the offering, will enable it to fund its operations into the first quarter of 2018 and continue acceleration and development of key research and clinical development programs; and
Announced increased prioritization of IMO-2125 with plans to initiate two additional multi-center clinical trials in 2017 both as monotherapy and in combination with check-point inhibitors in multiple tumor types.
"The third quarter of 2016 was a very productive period for our team at Idera and positions us well to close out the year very strong and carry that momentum into a catalyst rich 2017," stated Vincent Milano, Idera’s Chief Executive Officer "As I noted in late September, we are incredibly energized by the IMO-2125 data we announced in such an early phase of the development and are now mobilized to advance this program rapidly, to potentially alter the lives of other patients who have exhausted all other good options."

Continued Milano, "I am also proud of the conduct of our team to complete all the work that was necessary to inform and enable our recent decision to suspend work on the B-cell program, which, while difficult, allows us to redirect additional resources to accelerate the development of IMO-2125. We remain excited for the prospects of dermatomyositis with IMO-8400 and we are looking forward to being in a position to go into greater detail in January on our plans to begin the clinical phases of development with the 3GA platform."

Research and Development Program Updates
IMO-2125 and IMO-8400 are the Company’s lead clinical development drug candidates. IMO-2125 is an oligonucleotide-based agonist of Toll-like receptor (TLR) 9. IMO-8400 is an oligonucleotide-based antagonist of TLRs 7, 8, and 9. The Company also announced, in late 2015, the first two potential development targets from its proprietary 3GA technology platform: NLRP3 (NOD-like receptor family, pyrin domain containing protein 3) and DUX4 (Double Homeobox 4). The Company continues to evaluate these and other potential targets. The Company plans to take the first 3GA candidate into human proof of concept studies in 2017.

Toll-like Receptor (TLR) Agonism

Immuno-Oncology Program
Idera’s development program in immuno-oncology is based on the rationale that intra-tumoral injections of IMO-2125, a TLR9 agonist, will activate dendritic cells and modulate the tumor microenvironment to potentiate the anti-tumor activity of checkpoint inhibitors and other immunotherapies. This rationale is supported by pre-clinical data in multiple tumor types. These pre-clinical studies led Idera into a strategic alliance with the University of Texas MD Anderson Cancer Center to evaluate the combination of intratumoral IMO-2125 with checkpoint inhibitors.

In late 2015, Idera announced the initiation of a Phase 1/2 clinical trial of intratumoral IMO-2125 in combination with ipilimumab, a CTLA4 antibody, which is being conducted at the University of Texas MD Anderson Cancer Center. This trial is being conducted in patients with relapsed or refractory metastatic melanoma who have failed prior PD-1 therapy. In September 2016, the Company announced positive preliminary clinical data from the initial dosing cohorts in the ipilimumab arm of the dose escalation portion of the trial. The trial has recently been amended to also include the evaluation of the combination of intratumoral IMO-2125 with pembrolizumab, an anti-PD1 antibody, with enrollment in this arm now underway. The Company plans to expand the trial to additional clinical trial sites to conduct the phase 2 portion of the trial.

The results announced are summarized as follows:

Safety

10 patients in 3 dosing cohorts (4mg, 8mg and 16mg) were dosed and assessable for safety, as of the September 19, 2016 cutoff date;
IMO-2125 in combination with ipilimumab was being generally well tolerated at all 3 dose levels;
Immune related adverse events have been observed in 3 subjects: 2 responding patients have experienced hypophysitis and 1 patient has discontinued the study due to a recurrence of immune related hepatitis previously observed on pre-study therapy with ipilimumab;
No dose limiting toxicities (DLTs) were identified and the study is currently enrolling at the highest (32mg) dosing cohort in combination with ipilimumab.
Clinical activity

6 patients treated in the first two dosing cohorts (4mg and 8mg) were assessable for initial clinical activity, as of the September 19, 2016 cutoff date;
3 of the 4 patients with cutaneous melanoma were investigator-assessed responders with one Complete Response (CR) and 2 Partial Responses (PR).
Translational observations

Translational data seen through the first two dosing cohorts (4mg and 8mg) were promising relative to the induction of immune responses and consistent with the underlying hypothesis of the mechanism of action;
Detailed information on the translational findings from biopsies taken in the first two dosing cohorts and the relationship of these to clinical response is the subject of an accepted oral presentation on November 11, 2016 at the 2016 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting by Cara Haymaker, Ph.D., University of Texas, MD Anderson Cancer Center.
The Company also announced plans to take another data cut at the end of 2016 and request an End of Phase 1 (EOP) meeting with the U.S. Food and Drug Administration to discuss next steps and the path to a regulatory filing. The Company also anticipates requesting a meeting with the European Medicines Agency (EMA) for scientific advice.

Idera also plans to initiate trials to explore IMO-2125 as a monotherapy in multiple tumor types as well as a Phase 2 basket study of IMO-2125 in combination with check point inhibitors in additional tumor types beyond melanoma. Both of these studies are planned to initiate in 2017.

Toll-like Receptor (TLR) Antagonism

Dermatomyositis Clinical Development Program
In late 2015, Idera announced the initiation of a Phase 2 clinical trial of IMO-8400 in patients with dermatomyositis, a rare auto-immune condition, which negatively affects skin and may result in debilitating muscle weakness. TLRs have been reported to play a role in the pathogenesis of the disease. This randomized, double-blind, placebo controlled Phase 2 trial is expected to enroll 36 patients will be conducted at approximately 22 clinical sites worldwide. The Company plans to complete enrollment of this trial by the end of 2017 and have clinical data available in early 2018.

B-cell Lymphoma Clinical Development Program
In September 2016, Idera announced that the company had suspended the clinical development of IMO-8400 for B-cell lymphomas, including studies in Waldenstroms Macroglobulinemia (WM) and Diffuse Large B-Cell Lymphoma (DLBCL), and planned to explore strategic options in these indications. This decision was based upon the prioritization of the clinical development plans for IMO-2125 and the Company’s assessment that the level of clinical activity seen in the WM trial does not support monotherapy, the very slow enrollment rate in DLBCL and the Company’s commercial assessment of IMO-8400. IMO-8400 was generally well tolerated at all dose levels evaluated in the studies.

Third Generation Antisense Platform (3GA)
Idera’s proprietary third-generation antisense (3GA) platform technology is focused on silencing the mRNA associated with disease causing genes. Idera has designed 3GA oligonucleotides to overcome specific challenges associated with earlier generation antisense technologies and RNAi technologies.

In late 2015, Idera announced the identification of NLRP3 (NOD-like receptor family, pyrin domain containing protein 3) and DUX4 (Double Homeobox 4) as initial gene targets to advance into IND-enabling activities, which will occur throughout 2016. Potential disease indications related to these targets include, but are not limited to, interstitial cystitis, lupus nephritis, uveitis and facioscapulohumeral muscular dystrophy (FSHD). Over the first three quarters of 2016, Idera has generated additional 3GA compounds for a series of additional gene targets, which join NLRP3 and DUX4 as potential gene targets for the first clinical development program. The Company is currently conducting clinical, regulatory and commercial analysis activities and conducting IND-enabling studies. The Company plans to enter the clinic in 2017 for the first clinical development program. These additional compounds will enable the Company to continue to expand its potential future pipeline opportunities for both internal development as well as partnerships in areas outside of Idera’s focus.

In August 2016, Idera presented new pre-clinical data demonstrating the novel mechanism of action of the 3GA platform at the Cold Springs Harbor Laboratory Conference on Regulatory & Non-Coding RNAs. Subsequently, Idera presented in September 2016, new pre-clinical data demonstrating how the 3GA platforms unique mechanism of action supports selective targeting of single point mutations as well as a pre-clinical data presentation of 3GA targeting of NLRP3 for the treatment of inflammatory disorders. These presentations were made at the 12th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS).

In late 2015, Idera entered into a collaboration and license agreement with GSK to research, develop and commercialize compounds from its 3GA technology for the treatment of undisclosed, selected renal targets. As per the terms of the agreement, Idera received an upfront payment of $2.5 million and is eligible to receive up to approximately $100 million in milestone payments, including the $2.5 million payment, in addition to royalties.

Financial Results

Third Quarter 2016 Results

Net loss for the three months ended September 30, 2016 was $12.9 million, or $(0.10) per basic and diluted share, compared to a net loss of $11.4 million, or $(0.10) per basic and diluted share, for the same period in 2015. Revenue totaled $0.3 million and $0.9 million during the three and nine months ended September 30, 2016, respectively. There was nominal revenue recognized during the corresponding 2015 periods. For the nine month period ended September 30, 2016, the Company’s net loss was $39.2 million, or $(0.32) per basic and diluted share, compared to a net loss of $36.6 million, or $(0.32) per diluted share, for the same period in 2015.

Research and development expenses for the three months ended September 30, 2016 totaled $9.4 million compared to $7.5 million for the same period in 2015. For the nine month period ended September 30, 2016, research and development expenses totaled $28.8 million compared to $25.1 million for the same period in 2015.

General and administrative expense for the three months ended September 30, 2016 totaled $3.9 million compared to $4.0 million for the same period in 2015. For the nine month period ended September 30, 2016, general and administrative expenses totaled $11.6 million compared to $11.7 million for the same period in 2015.

As of September 30, 2016, Idera’s cash, cash equivalents and investments totaled $53.4 million compared to $87.2 million as of December 31, 2015.

In October 2016, the Company completed a public offering of its common stock, generating estimated net proceeds of $48.9M, after deducting underwriters’ discounts and commissions and estimated offering expenses, including from the partial exercise by the underwriters of their option to purchase additional shares in the offering, which option exercise is expected to close today. The Company believes that, based on its current operating plan, its existing cash, cash equivalents and investments, including the net proceeds from the offering, will enable it to fund its operations into the first quarter of 2018 and continue acceleration and development of key research and clinical development programs.