On August 6, 2015 Synta Pharmaceuticals Corp. (NASDAQ: SNTA) reported financial results for the second quarter ended June 30, 2015 and provided a pipeline update (Press release, Synta Pharmaceuticals, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076498 [SID:1234507077]).

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"The ganetespib development program is approaching its first key milestone, with the Phase 3 GALAXY-2 trial in non-small cell lung cancer nearing its first interim analysis, which is anticipated by year end, followed by the second interim and final analyses expected in 2016," said Chen Schor, President and Chief Executive Officer of Synta. "A positive outcome of this trial has the potential to be transformational for Synta, bringing us closer to our goal of making this novel therapeutic with a unique mechanism of action available to non-small cell lung cancer patients in need of additional treatment options. Ganetespib is also being evaluated in a series of large, randomized investigator-sponsored studies for other indications, including AML, ovarian cancer and breast cancer, and we continue to move the lead candidate from our HDC program, STA-12-8666, toward the clinic. Each of these programs continues to make important progress toward value-creating milestones, and we look forward to providing updates in the months ahead."

Second Quarter Accomplishments and Recent Updates

Pivotal, Phase 3 GALAXY-2 Clinical Trial Remains on Track for Interim Analysis of Overall Survival in 2015. The Company’s pivotal GALAXY-2 trial, a Phase 3 global, randomized, multi-center study comparing the combination of ganetespib and docetaxel to docetaxel alone for the second-line treatment of advanced non-small cell lung adenocarcinoma, remains on track to meet previously provided data readout timelines. Ganetespib, the Company’s lead program, is a novel, potent small molecule inhibitor of heat shock protein 90 (Hsp90). Based on current projections and statistical assumptions, the Company expects that the first interim overall survival (OS) analysis of GALAXY-2 will be conducted by the end of 2015, and the second interim and final OS analysis will be conducted in 2016. Assuming positive interim results from the ongoing GALAXY-2 trial of ganetespib, and pending regulatory feedback, the Company plans to seek regulatory approval of ganetespib for NSCLC in 2016.

Results from the Phase 2 GALAXY-1 trial published in Annals of Oncology. Results from the Company’s Phase 2 GALAXY-1 trial were published in the May 21, online first issue of the journal Annals of Oncology. GALAXY-1 was a global, randomized, multi-center study designed to identify the patients with advanced NSCLC most likely to benefit from second-line treatment with ganetespib in combination with docetaxel versus docetaxel alone. The results from this trial demonstrated that patients diagnosed with advanced non-small cell lung adenocarcinoma more than six months prior to study entry derived the most benefit from combination treatment, leading to the selection of this population for the ongoing Phase 3 GALAXY-2 trial.

First patient enrolled in Phase 2 Portion of GANNET53 Study of ganetespib in ovarian cancer. In June, Synta announced commencement of patient enrollment in the Phase 2 portion of the GANNET53 study, a randomized, pan-European study evaluating ganetespib in combination with paclitaxel vs. paclitaxel alone in over 200 patients with metastatic, predominantly p53 mutant, platinum-resistant ovarian cancer. Enrollment in the Phase 2 portion of GANNET53 follows the successful completion of the Phase 1 portion, the results of which were recently presented at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago. The Phase 1 data demonstrated that the combination of ganetespib 150 mg/m² with paclitaxel 80 mg/m² once weekly for 3 out of 4 weeks was generally well tolerated, with no dose limiting toxicities, and was therefore chosen for the randomized phase 2 trial. GANNET53 is sponsored by Innsbruck Medical University in Austria and funded by the European Commission.

Results from three investigator-sponsored trials of ganetespib and preclinical results of STA-12-8666 presented at ASCO (Free ASCO Whitepaper). Promising results from three studies evaluating ganetespib combination therapy in ALK-positive lung cancer, platinum-resistant ovarian cancer, and rectal cancer were presented at the 2015 ASCO (Free ASCO Whitepaper) Annual Meeting. In addition, preclinical results for the Company’s lead HDC candidate, STA-12-8666, in pediatric sarcoma were also presented at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting. STA-12-8666 is a conjugate of an Hsp90 inhibitor and SN-38, the active metabolite of the widely used drug irinotecan. The Company remains on track for an IND submission by the first quarter of 2016 to begin clinical studies of STA-12-8666.
Second Quarter 2015 Financial Results

There were no revenues recognized in the second quarters of 2015 and 2014.

Research and development expenses were $16.4 million for the second quarter in 2015, compared to $18.8 million for the same period in 2014. General and administrative expenses were $3.1 million for the second quarter in 2015, compared to $2.9 million for the same period in 2014.

The Company reported a net loss of $19.8 million, or $0.15 per basic and diluted share, in the second quarter of 2015, compared to a net loss of $22.3 million, or $0.24 per basic and diluted share, for the same period in 2014.

As of June 30, 2015, the Company had $98.3 million in cash, cash equivalents and marketable securities, compared to $97.7 million in cash, cash equivalents and marketable securities as of December 31, 2014.

More detailed financial information and analysis may be found in the Company’s Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission (SEC) on August 6, 2015.

Guidance

The Company expects its cash, cash equivalents and marketable securities of approximately $98.3 million as of June 30, 2015 will be sufficient to fund operations at least through the first half of 2016. This estimate assumes no additional funding from new partnership agreements, equity financings or further sales under its ATM facility. The timing and nature of certain activities contemplated for the remainder of 2015 and 2016 will be conducted subject to the availability of sufficient financial resources.

On Ausgt 6, 2015 Epizyme, Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, reported business highlights and operating and financial results for the second quarter of 2015 (Press release, Epizyme, AUG 6, 2015, View Source [SID:1234507072]).

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"As we enter the third quarter of 2015, Epizyme is in a strong position. Having regained global rights ex-Japan to tazemetostat, our lead clinical candidate, we are actively moving the program forward and expanding our clinical development activities," said Robert Gould, Ph.D., President and Chief Executive Officer, Epizyme. "The company made significant progress advancing tazemetostat during the quarter. Importantly, we initiated the phase 2 NHL study and completed the transition of development-related transition activities from Eisai. Beyond tazemetostat, we look forward to working with Celgene on the three HMT targets defined under our renewed collaboration agreement. We are on strong financial footing and are well positioned to advance the development of our clinical programs and platform. As we announced yesterday, we have selected Rob Bazemore to succeed me as President and Chief Executive Officer, positioning us for continued success into the future."

Program Summaries

Tazemetostat (EPZ-6438):

In the second quarter of 2015, Epizyme initiated a phase 2 monotherapy trial of its lead clinical candidate, tazemetostat, in patients with relapsed or refractory non-Hodgkin lymphoma (NHL). This five-arm study will enroll up to 150 patients with germinal center diffuse large B cell lymphoma (DLBCL) or follicular lymphoma, stratified by those expressing mutant EZH2 and those expressing wild type EZH2, as well as patients with non-germinal center DLBCL. The initial data from this study is expected in mid-2016.

The phase 1 study in relapsed or refractory NHL and advanced solid tumors is ongoing, with enrollment complete in the dose escalation and dose expansion cohorts. Enrollment in the clinical pharmacology portion of the study is ongoing. Epizyme will present updated data from patients with advanced solid tumors in the phase 1 study at ESMO (Free ESMO Whitepaper)’s European Cancer Congress in Vienna, Austria on September 26. Additional data from patients with NHL in the phase 1 study are expected to be presented at a medical meeting before the end of 2015. Results from the phase 1 trial presented at the International Congress on Malignant Lymphoma on June 20 showed tazemetostat as a monotherapy produced durable objective responses in heavily pre-treated patients with relapsed or refractory NHL, with an acceptable safety and tolerability profile.

Epizyme intends to initiate a phase 1 clinical study in pediatric patients with INI1-negative tumors or synovial sarcoma and a phase 2 clinical study in adult patients with INI1-negative tumors or synovial sarcoma in the second half of 2015.

Pinometostat (EPZ-5676):

Epizyme will voluntarily cease patient enrollment into the phase 1 study of pinometostat in adult patients with MLL-rearranged acute leukemia in the third quarter of 2015. The decision, made together with Celgene, is based on insufficient efficacy seen to date with monotherapy treatment in this population. The company expects to present final study results after all patients conclude treatment and data analyses are complete. A separate dose-escalation study of pinometostat in pediatric patients is ongoing and enrollment is expected to be completed in the second half of 2015.

Epizyme and Celgene plan to explore pinometostat in combination with other agents based on encouraging preclinical data.

Celgene collaboration update

Subsequent to the second quarter, Epizyme amended and restated its agreement with Celgene Corporation to extend the research collaboration between the two companies for at least three additional years. Epizyme received a $10 million upfront payment in exchange for an extension of Celgene’s option rights to individually license global rights for two histone methyltransferase (HMT) targets and ex-US rights for a third HMT target. Celgene may exercise its option with respect to each of the targets at the time of the IND filing for a pre-specified license payment. Following the completion of phase 1, if Celgene chooses to continue its license for a specific target, it may do so by making an additional pre-specified license payment.

Epizyme will be responsible for leading and funding development for each target candidate through phase 1 clinical trials. Epizyme may earn total potential milestones of up to $610 million on the three targets, including up to $75 million in development milestones and license fees, $365 million in regulatory milestones, and $170 million in sales milestones. Epizyme also may earn a royalty of up to a low double-digit percentage on worldwide net product sales relating to two of the targets, and on ex-US annual net sales relating to the third target. Epizyme retains global rights to the remainder of its preclinical pipeline.

Second Quarter 2015 Financial Results

Collaboration Revenue: Collaboration revenue was $0.7 million in the second quarter of 2015 and $1.6 million for the six months ended June 30, 2015 compared with $9.5 million and $22.9 million in the comparable periods of 2014. The decline in collaboration revenue primarily reflects the completion of our research obligations under the Eisai agreement by the end of 2014 and under the GSK agreement by January 2015, as well as a decrease in revenue recognized under the Celgene agreement due to the Company’s satisfaction of certain of its performance obligations under the agreement during Q4 2014.

R&D Expenses: Research and development expenses were $20.6 million for the second quarter 2015 and $77.6 million for the six months ended June 30, 2015 compared to $17.5 million and $32.8 million for the comparable periods of 2014. The expansion of tazemetostat clinical trials and related EZH2 activities and the $40.0 million upfront payment to Eisai in the first quarter of 2015 drove the increase in spending in comparison to the three and six months ended June 30, 2014. Epizyme expects development expenses will continue to increase in 2015 as compared to 2014 since the Company is now solely responsible for funding tazemetostat clinical trials and related development costs outside of Japan.

G&A Expenses: General and administrative expenses were $6.0 million for the second quarter 2015 and $11.2 million for the six months ended June 30, 2015 compared with $5.3 million and $10.3 million in the comparable periods in 2014. The increase in G&A expense was largely related to the increased infrastructure to support the expanding clinical development program and an increase in patent filings. We expect G&A expense to increase slightly as compared to current spending levels for the remainder of 2015.

Net Loss: Net loss was $25.8 million in the second quarter 2015 and $87.1 million for the six months ended June 30, 2015 compared with $13.4 million and $20.3 million in the comparable periods in 2014.

Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2015 were $236.7 million, compared with $190.1 million as of December 31, 2014. Epizyme’s follow-on public offering in March 2015 raised $117.0 million in proceeds before expenses and the exercise of the underwriters’ over-allotment option provided an additional $13.7 million in proceeds before expenses. The company received an upfront payment of $10.0 million under the amended and restated collaboration and license agreement with Celgene in July 2015. The company expects that, based on its current operating plan, cash and equivalents will be sufficient to fund its operating expenses and capital expenditure requirements through at least the end of the second quarter of 2017 prior to including any potential license fees or future milestone payments.

Shares Outstanding: Shares outstanding as of June 30, 2015 were 41.2 million. Weighted average shares outstanding were 41.1 million and 38.1 million for the three and six months ended June 30, 2015 respectively and 33.2 million and 32.1 million for the comparable periods in 2014.

On August 6, 2015 Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the second quarter ended June 30, 2015 (Press release, Oncolytics Biotech, AUG 6, 2015, View Source [SID:1234507069]).

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"Subsequent to quarter end we announced compelling overall, one- and two-year survival data from the REO 017 study in patients with advanced pancreatic cancer treated with gemcitabine and REOLYSIN," said Dr. Brad Thompson, President and CEO of Oncolytics. "During the quarter we also added to our growing body of evidence that REOLYSIN contributes to the upregulation of PD-1 and PD-L1 and so may play a role in immunotherapeutic treatment of cancer."

Selected Highlights

Since April 1, 2015, selected highlights announced by the Company include:

Clinical Program

Presentation of final data from a single arm clinical study examining the use of REOLYSIN in combination with gemcitabine in patients with advanced pancreatic cancer (REO 017), which showed an increase in median overall survival, as well as an approximate two-fold increase in one-year survival rates, and a five-fold increase in two-year survival rates when compared to gemcitabine therapy alone as seen in historical data;

An update on the planned registration program for REOLYSIN including an initial focus on two indications: the neoadjuvant treatment of muscle-invasive bladder cancer and the treatment of glioblastoma;

Activation of an Investigational New Drug Application containing the protocol titled "MC1472: Phase 1 Study of Replication Competent Reovirus (REOLYSIN) in Combination with GM-CSF in Pediatric Patients with Relapsed or Refractory Brain Tumors";

Presentation of data showing up regulation of PD-1 and PD-L1 from a single arm clinical study examining the use of REOLYSIN in patients with primary glioblastomas or brain metastases (REO 013b) at the Royal Society of Medicine’s Immuno-oncology: Using the Body’s Own Weapons conference, held in London, UK;

Regulatory

Granting of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for REOLYSIN in the treatment of gastric cancer and malignant gliomas;
Granting of Orphan Drug Designation by the European Medicines Agency for REOLYSIN in the treatment of pancreatic cancer;

Basic Research

Presentation of preclinical data at the 9th International Conference on Oncolytic Virus Therapeutics in Boston, MA, including findings around REOLYSIN’s mechanism of action and its potential in new indications including chronic lymphocytic leukemia;
Presentation of clinical and preclinical data at the 2015 Immune Checkpoint Inhibitors meeting in Boston, MA, including content showing the combination of REOLYSIN, GM-CSF, anti-PD-1 and anti-CTLA-4 improved survival in immune competent mice versus REOLYSIN and GM-CSF alone, and REOLYSIN and GM-CSF plus either one of the checkpoint inhibitors alone;
A series of presentations made by the Company’s research collaborators at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held in Philadelphia, PA covering preclinical research in a range of indications, with a variety of treatment combinations including REOLYSIN;

Corporate

Linda Hohol resigned from the Board of Directors of the Company effective August 5, 2015. Ms. Hohol has served as a Director since June 2014; and

Financial

At June 30, 2015 the Company reported $32.1 million in cash, cash equivalents and short-term investments. At August 5, 2015, the Company had approximately $31.6 million in cash, cash equivalents and short-term investments.

On August 6, 2015 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its second quarter 2015 financial results and ongoing progress with duvelisib an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma (Press release, Infinity Pharmaceuticals, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076561 [SID:1234507068]). Infinity also announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the investigation of duvelisib for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. The FDA established the Fast Track designation process to facilitate the development and expedite the review of investigational medicines intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Infinity is conducting registration-focused trials evaluating the safety and efficacy of duvelisib, including DYNAMOTM, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma (iNHL), and DUOTM, a Phase 3 study in patients with CLL.

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"The quarter was marked by continued clinical development progress for duvelisib, particularly with DYNAMO and DUO. The first completion of enrollment in either DYNAMO or DUO, both of which we expect to occur in the second half of this year, will trigger a $130 million milestone payment from AbbVie, our global development and commercialization partner for duvelisib in oncology," stated Adelene Perkins, Infinity’s chair, president and chief executive officer. "We are also pleased to have recently received Fast Track designation for the investigation of duvelisib for the treatment of chronic lymphocytic leukemia, which supports our belief in the potential of duvelisib to help fill an important medical need. We look forward to leveraging the opportunities that Fast Track designation allows in order to maximize the possibility of an accelerated path to approval."

Duvelisib is the only investigational PI3K-delta,gamma inhibitor in Phase 3 clinical development and has the potential to be a first-in-class treatment for certain types of hematologic malignancies, or blood cancers. In addition to the DYNAMO and DUO studies, Infinity is continuing to enroll patients in CONTEMPO, a Phase 1b/2 study in treatment-naïve patients with follicular lymphoma, and SYNCHRONY, a Phase 1b study in CLL patients whose disease is refractory to or has relapsed while receiving a BTK inhibitor. Infinity also expects that the first clinical study of duvelisib in combination with venetoclax, AbbVie’s first-in-class investigational B-cell lymphoma-2 (BCL-2) selective inhibitor, will begin this year.

At the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), preclinical data were presented showing in vitro synergy between duvelisib and venetoclax, and the combination of duvelisib plus venetoclax showed greater inhibition of lymphoma tumor growth compared to each of these agents alone. These preclinical data provide support for the first clinical study combining duvelisib and venetoclax in patients with hematologic malignancies.

Second Quarter 2015 Financial Results

At June 30, 2015, Infinity had total cash, cash equivalents and available-for-sale securities of $199.5 million, compared to $233.6 million at March 31, 2015.
Revenue during the second quarter of 2015 was $4.9 million for research and development (R&D) services associated with the strategic collaboration with AbbVie for duvelisib in oncology. Infinity did not record any revenue in the second quarter of 2014.
R&D expense for the second quarter of 2015 was $34.1 million, compared to $28.2 million for the second quarter of 2014. The increase in R&D expense was primarily due to higher contingent cash compensation and expenses related to early discovery programs.
General and administrative (G&A) expense was $9.4 million for the second quarter of 2015, compared to $7.1 million for the same period in 2014. The increase in G&A expense was primarily related to higher contingent cash compensation.
Net loss for the second quarter of 2015 was $38.4 million, or a basic and diluted loss per common share of $0.78, compared to $38.0 million, or a basic and diluted loss per common share of $0.78, for the same period in 2014.
Conference Call Information

Infinity will host a conference call today at 8:30 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) or 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 72290673. An archived version of the webcast will be available on Infinity’s website for 30 days.

Infinity R&D Day, October 6, 2015

Infinity will host an R&D Day in New York City on Tuesday, October 6, 2015, from 7:30 a.m. to 12:00 p.m. ET. The event will be webcast beginning at 8:00 a.m. ET and can be accessed in the Investors/Media section of Infinity’s website, www.infi.com. A replay of the event will also be available.

About Duvelisib

Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins with predominantly non-overlapping roles known to support the growth and survival of malignant B-cells.[i] Preclinical data suggest that PI3K-delta signaling can lead to the proliferation of malignant B-cells, and both PI3K-gamma and PI3K-delta play a role in the formation and maintenance of the supportive tumor microenvironment.[ii] Duvelisib is the only investigational PI3K-delta,gamma inhibitor in Phase 3 clinical development and has the potential to be a first-in-class treatment for certain types of hematologic malignancies, or blood cancers. AbbVie and Infinity Pharmaceuticals, Inc. are jointly developing duvelisib in oncology.

Duvelisib is being evaluated in registration-focused studies, including DYNAMOTM, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma, and DUOTM, a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On August 6, 2015 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 second quarter ended June 30, 2015 (Press release, Idera Pharmaceuticals, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076539 [SID:1234507065]).

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"From a program execution perspective, we’ve continued to make steady progress across the board during the second quarter of 2015," stated Vincent Milano, Idera’s Chief Executive Officer. "We recently announced our strategic clinical research alliance with MD Anderson, with the first planned study of this alliance evaluating the combination of IMO-2125 (TLR9 agonist) and ipilimumab (an anti-CTLA4 antibody) in melanoma patients. We are targeting commencing this study in the fourth quarter of this year. Our B-cell lymphoma programs with IMO-8400 (TLR7, 8 and 9 antagonist) are advancing, as we are rapidly approaching the release of data from the Waldenström’s macroglobulinemia (WM) trial in the fourth quarter. Also in the second quarter, we began enrolling patients into the first dose cohort in the diffuse large B-cell lymphoma (DLBCL) clinical trial. Our rare disease programs are moving forward nicely, most notably with the initiation of our dermatomyositis Phase 2 study planned for the fourth quarter. Finally, we continue to expect to announce the first two diseases we plan to target with our exciting third generation antisense platform technology, which was previously referred to as our GSO program, by the end of this year."

Continued Milano, "Our team at Idera has made good progress executing against the goals that we established for ourselves at the beginning of the year. Importantly, I am pleased with the progress we’ve made developing and implementing a corporate culture and value system that aligns all facets of our company towards both near and long term success. While these are not necessary externally-viewed measures, they are paramount elements to any organization that places high expectations upon itself. During the most recent quarter, we’ve added several extremely skilled individuals to our team who’ve made immediate impacts on our organization and programs to enhance our ability to achieve our goals. By no means have we completed building out our team at Idera, however, I am pleased with the progress that has been made to date; and with this group’s ability to adapt and grow, while continuing to remain focused and execute our programs with the rigor that is necessary."

Research and Development Program Updates

Toll-like Receptor (TLR) Agonism Program

Immuno-Oncology Program

In June 2015, the company announced that it had entered into a strategic clinical research alliance with MD Anderson Cancer Center to advance the clinical development of intratumoral TLR9 agonists in combination with checkpoint inhibitors. The company also announced that it expects to initiate the first trial from the alliance, a Phase 1/2 study to assess the safety and efficacy of intratumoral IMO-2125 in combination with ipilimumab in approximately 45 patients with metastatic melanoma. The company intends to initiate this study in the fourth quarter of 2015 with data expected in 2016. Planning of additional studies as part of the clinical research alliance with MD Anderson Cancer Center is in progress. Additionally, the company recently has had two abstracts accepted with new pre-clinical data on intratumoral IMO-2125 activity, and its impact on the tumor microenvironment and checkpoints at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) taking place in September in New York.

Toll-like Receptor (TLR) Antagonism Programs

Genetically Defined Forms of B-cell Lymphoma

Idera’s program in genetically defined forms of B-cell lymphoma is based on independent research conducted at Idera. Pre-clinical studies have demonstrated that, in certain B-cell lymphomas, the presence of the MYD88 L265P oncogenic mutation led to over-activation of TLR7 and TLR9 signaling and that blocking these TLRs with our antagonists promoted tumor cell death.

In the company’s Phase 1/2 study in Waldenstrom’s macroglobulinemia, the targeted number of patients at each of the three dose levels have completed assessment through the end of their first cycle of treatment and the dose escalation portion of the study has been completed. The trial is designed to evaluate IMO-8400’s safety, tolerability and potential clinical activity in patients who have a history of relapse after or failure to respond to prior therapies. Idera anticipates data from this trial will be available in the fourth quarter of 2015.

During the second quarter the company also continued to activate clinical sites and enroll patients into the first of three dose cohorts of our Phase 1/2 clinical trial of IMO-8400 in patients with relapsed or refractory DLBCL, who are harboring the MYD88 L265P oncogenic mutation. The company anticipates that data from this trial will be available in 2016. Idera also announced during the second quarter that the U.S. Food and Drug Administration (FDA) had granted us orphan drug designation for IMO-8400 for the treatment of DLBCL.

Rare Disease Programs

The company is planning to initiate clinical development of IMO-8400 for the treatment of rare diseases. The company has selected dermatomyositis and Duchenne muscular dystrophy (DMD) as the first rare diseases for which we plan to develop IMO-8400. The company selected these indications for development based on the reported increase in TLR expression in these disease states, expression of cytokines indicative of key TLR-mediated pathways, the identification of prospective biomarkers for evaluation in early clinical trials and significant unmet needs. The company anticipates commencing clinical development in these two indications by initiating a Phase 2 clinical trial in dermatomyositis by the end of 2015 and a Phase 2 clinical trial in DMD in 2016.

Third Generation Antisense Platform

The company is currently undertaking an analysis and prioritization of oncology and rare disease indications for potential development of drug candidates from our third generation antisense technology platform. Idera’s key considerations in identifying disease indications in our third generation antisense program include: strong evidence that the disease is caused by a specific protein; clear criteria to identify a target patient population; biomarkers for early assessment of clinical proof-of-concept; a targeted therapeutic mechanism for action; and unmet medical need to allow for a well-defined development path to approval and commercial opportunity. The company is currently conducting disease model studies and plans to begin IND-enabling development programs in the first two disease indications selected for further development in our third generation antisense program in the second half of 2015.

Recent Corporate Highlights

In June 2015, Idera announced the appointment of Mark J. Casey as General Counsel and Secretary of the Board of Directors.

Financial Results

Second Quarter 2015 Results

Net loss applicable to common stockholders for the three months ended June 30, 2015 was $12.7 million, or $0.11 per diluted share, compared to a net loss applicable to common stockholders of $8.4 million, or $0.10 per diluted share, for the same period in 2014. For the six month period ended June 30, 2015, the Company’s net loss applicable to common stockholders was $25.2 million, or $0.23 per diluted share, compared to a net loss applicable to common stockholders of $17.6 million, or $0.22 per diluted share, for the same period in 2014. The company recognized nominal revenue in the second quarter and six month periods of 2015 and 2014.

Research and development expenses for the three months ended June 30, 2015 totaled $9.0 million compared to $5.6 million for the same period in 2014. For the six month period ended June 30, 2015, research and development expenses totaled $17.7 million compared to $12.6 million for the same period in 2014.

General and administrative expenses for the three months ended June 30, 2015 totaled $3.8 million compared to $2.7 million for the same period in 2014. For the six month period ended June 30, 2015, general and administrative expenses totaled $7.7 million compared to $4.8 million for the same period in 2014.

As of June 30, 2015, Idera’s cash, cash equivalents and investments totaled $106.3 million compared to $48.6 million as of December 31, 2014.