On August 6, 2015 Varian Medical Systems reported that treatment planning for radiotherapy and radiosurgery can be significantly expedited and improved using new software for storing and accessing clinical knowledge based on best planning practices (Press release, InfiMed, AUG 6, 2015, View Source [SID:1234507059]). This was the finding of several research teams that compared conventional plans with plans generated using knowledge-based treatment planning software like the RapidPlan tool from Varian Medical Systems (NYSE: VAR). The researchers from diverse institutions recently presented their findings during the 2015 American Association of Physicists in Medicine (AAPM) annual meeting.

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Plan generation that typically took 30 to 180 minutes was completed in just 15 to 20 minutes using a model based on 48 spine tumor cases, created by Joy Foy, MSE, and colleagues from the University of Michigan. "RapidPlan knowledge-based planning greatly decreased the amount of time required to achieve high quality treatment plans with minimal human intervention and could feasibly be used to standardize plan quality between institutions," the researchers found.1

RapidPlan enables clinicians to extract information from past clinical experience and use it to generate mathematical models that expedite the creation of new treatment plans. The software helps the planner quickly generate a new treatment plan that achieves the radiation oncologist’s tumor coverage and normal tissue sparing goals, greatly reducing the need for time-consuming, manual trial-and-error processes. Knowledge-based treatment planning is becoming a routine practice for quality control, according to researchers from the University of Texas MD Anderson Cancer Center in Houston and Duke University Medical Center in Durham, NC. 2

Munther Ajlouni, MD; Karen Snyder, MS; and their colleagues at the Henry Ford Health System in Detroit, MI, developed a RapidPlan model based on 105 manually created SBRT lung cancer treatment plans. They found that RapidPlan generated treatment plans with comparable quality to manually created plans but with increased consistency and greater efficiency.3

Jason Pawlowski, PhD, medical physicist at Sarah Cannon, presented work from Sarah Cannon radiation oncology site colleagues across the nation aimed to develop and validate a knowledge-based planning model for treating locally advanced non-small cell lung cancer. The Sarah Cannon radiation oncology team found that the RapidPlan model more quickly achieved treatment plans that were equivalent, or superior to, previously-created manually optimized plans of the same patients.4

Changsheng Ma, MD and Yong Yi, MD from the Shandong Tumor Hospital in Jinan, Shangdong Province, China, used RapidPlan and data from 20 patient cases to develop a RapidPlan model for treating cervical cancer with IMRT. This approach "can generate clinically acceptable treatment plans of high quality, while improving the efficiency of the treatment planning process." they reported. 5

On August 6, 2015 GTx, Inc. (Nasdaq: GTXI) reported financial results for the quarter and six months ended June 30, 2015, and highlighted recent accomplishments and developments (Press release, GTx, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076477 [SID:1234507058]). The Company has initiated its Phase 2 clinical trial of enobosarm in androgen receptor positive (AR+) triple negative breast cancer (TNBC) and anticipates initiating this quarter an additional Phase 2 clinical study of enobosarm to treat AR+ and estrogen receptor positive (ER+) breast cancer. The Company also is evaluating several selective androgen receptor modulator (SARM) compounds in preclinical models of Duchenne muscular dystrophy (DMD) where a SARM’s ability to increase muscle mass may prove beneficial to patients suffering from DMD.

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"I am pleased that we have initiated our Phase 2 clinical study of AR+ triple negative breast cancer, and I look forward to having our first patient enrolled this quarter," said Marc S. Hanover, CEO of GTx.

"Our primary focus continues to be developing enobosarm for the treatment of advanced breast cancer and the preclinical development of our newly licensed selective androgen receptor degrader program," said Dr. Robert J. Wills, Executive Chairman of GTx. "In addition, the extensive SARM data from our preclinical and clinical development efforts, together with input from leading experts in areas of muscle disorders, has encouraged us to undertake preclinical studies to determine whether SARMs offer a treatment option for DMD."

Corporate Highlights

Enobosarm, a SARM, is the Company’s lead product candidate and is being developed as a targeted treatment for two advanced breast cancer indications for (i) AR+ TNBC and (ii) ER+ and AR+ breast cancer. For both clinical trials, the primary efficacy objective will be clinical benefit, which is defined as a complete response, partial response or stable disease by Response Evaluation Criteria in Solid Tumors 1.1.

The Company initiated its open-label, proof-of-concept Phase 2 clinical trial of a daily dose of 18 mg of enobosarm in patients with advanced AR+ TNBC. The study will enroll up to 55 patients to obtain 41 evaluable patients for the primary efficacy objective defined as clinical benefit at 16 weeks. There will be two stages of evaluation in the clinical trial with the first stage assessment occurring following 16 weeks of treatment for the first 21 evaluable patients. If at least 2 of the 21 patients achieve clinical benefit, the trial will continue to enroll the second stage of the study.

In the third quarter of 2015, the Company plans to initiate an open-label Phase 2 clinical trial of enobosarm to assess clinical benefit in patients with ER+/AR+ advanced breast cancer. The study will enroll up to 118 patients to obtain 44 evaluable patients in each of two cohorts. One cohort will receive a daily dose of 9 mg of enobosarm and the other cohort a daily dose of 18 mg of enobosarm. There will be two stages of evaluation in the clinical trial with the first stage assessment occurring following 24 weeks of treatment for the first 18 evaluable patients in each of the two cohorts. If at least 3 of the 18 patients achieve clinical benefit in one or both cohorts, the trial will continue through the second stage for that cohort.

The Company is expecting data from the first stage of each Phase 2 clinical trial by the end of 2016.

Selective Androgen Receptor Degrader (SARD) technology is being evaluated as a potentially novel treatment for men with castration-resistant prostate cancer (CRPC), including those who do not respond or are resistant to currently approved therapies.

The Company believes that its SARD compounds will degrade multiple forms of the androgen receptor, including AR variants, such as ARv-7.

The Company is conducting research in collaboration with the University of Tennessee Health Science Center to select and optimize appropriate drug development candidates to move into the preclinical studies required to support initial clinical trials.
SARM’s ability to increase muscle mass may prove beneficial as a treatment for DMD.

DMD is a rare genetic disorder affecting approximately one in 3,000 boys. DMD is characterized by progressive muscle degeneration and weakness and represents a serious unmet medical need.

The Company is undertaking preclinical studies and has initiated discussions with experts to better understand the potential of SARMs as a treatment for DMD.

GTx-758 (Capesaris) for the treatment of advanced prostate cancer.

All patients in the Company’s open-label Phase 2 clinical trial of GTx-758 in men with metastatic and high risk non-metastatic CRPC have reached the primary endpoint assessment. Both the 125 mg and 250 mg doses have demonstrated dose dependent increases from baseline in sex hormone binding globulin (SHBG), reductions in free testosterone and reductions in prostate specific antigen (PSA), confirming the mechanism of action of GTx-758. Efficacy and safety data from the clinical trial will be presented at an appropriate scientific meeting and submitted for publication.

The Company is discussing this data with potential strategic partners to determine their interest in partnering or acquiring this asset, as well as the library of ER alpha agonist compounds.

Second Quarter and Six Months 2015 Financial Results

As of June 30, 2015, cash and short-term investments were $39.4 million compared to $49.3 million at December 31, 2014.
Loss from operations for the quarter ended June 30, 2015 was $5.0 million compared to $10.9 million for the same period of 2014. Loss from operations for the six months ended June 30, 2015 was $10.0 million compared to $19.9 million for the same period of 2014.

Research and development expenses for the quarter ended June 30, 2015 were $3.0 million compared to $7.9 million for the same period of 2014.

General and administrative expenses for the quarter ended June 30, 2015 were $2.0 million compared to $3.1 million for the same period of 2014.

The Company recognized a non-cash loss of $43.0 million and $40.4 million for the quarter and six months ended June 30, 2015, respectively, due to the change in fair value of the Company’s warrant liability. The Company classified the warrants issued in its November 2014 private placement as a liability due to certain provisions of the warrants that may require the Company, or its successor, to pay cash to warrant holders under certain circumstances through December 31, 2016. The Company anticipates recognizing non-cash gains or losses resulting from the revaluation of these warrants to fair value each reporting period through the earlier of December 31, 2016 or the exercise in full of these warrants.

The net loss for the quarter ended June 30, 2015 was $48.0 million compared to a net loss of $10.9 million for the same period in 2014. The net loss for the quarter ended June 30, 2015 included the above mentioned non-cash loss of $43.0 million related to the change in the fair value of the Company’s warrant liability. The net loss for the six months ended June 30, 2015 was $50.3 million compared to $19.9 million for the same period of 2014. The net loss for the six months ended June 30, 2015 included a non-cash loss of $40.4 million related to the change in fair value of the Company’s warrant liability.

GTx had approximately 140.4 million shares outstanding as of June 30, 2015. Additionally, there remain warrants outstanding to purchase approximately 64.3 million shares of GTx common stock at an exercise price of $0.85 per share.

On August 6, 2015 Emergent BioSolutions Inc. (NYSE:EBS) reported financial results for the quarter and six months ended June 30, 2015 (Press release, Emergent BioSolutions, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076503 [SID:1234507057]).

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Financial highlights include:
Total revenues: Q2 2015 of $126.1 million, up 14% over prior year; six months 2015 of $189.7 million, up 16% over prior year;
GAAP net income/loss: Q2 2015 net income of $14.1 million, or $0.32 per diluted share; six months 2015 net loss of $7.4 million, or $0.19 per diluted share;

Adjusted net income/loss: Q2 2015 net income of $17.0 million, or $0.36 per diluted share; six months 2015 net loss of $1.8 million, or $0.05 per diluted share;

EBITDA: Q2 2015 of $29.6 million, or $0.62 per diluted share; six months 2015 of $9.6 million, or $0.25 per diluted share; and
Adjusted EBITDA: Q2 2015 of $31.0 million, or $0.65 per diluted share; six months 2015 of $12.2 million, or $0.32 per diluted share.

2015 business accomplishments:

FDA approval of Anthrasil (Anthrax Immune Globulin Intravenous (Human))
Awards to manufacture Ebola monoclonal antibodies under our CIADM arrangement with BARDA
Successful dosing of our first patient in the Phase I trial for MOR209/ES414, our immunotherapeutic treatment for prostate cancer
FDA approval and launch of IXINITY, a recombinant factor IX treatment for Hemophilia B
Continued steady progress on Building 55 sBLA approval

2015 outlook:

Reaffirmation of previous guidance – FY 2015 total revenues of $510-$540 million, net income of $50-$60 million (GAAP) and $60-$70 million (adjusted); and

New guidance – Q3 2015 total revenues of $140 to $155 million.

2015 FINANCIAL PERFORMANCE
(I) Quarter Ended June 30, 2015 (unaudited)

Revenues

Product Sales

For Q2 2015, product sales were $82.0 million, an increase of 5% as compared to 2014. The increase primarily reflects increased sales of BioThrax during the quarter.

Contract Manufacturing

For Q2 2015, revenue from our contract manufacturing operations was $8.9 million, a decrease of 3% as compared to 2014. The decrease was primarily due to the timing of fill/finish facility service to third parties.
Contracts, Grants and Collaborations
For Q2 2015, contracts, grants and collaborations revenue was $35.2 million, an increase of 54% as compared to 2014. The increase was primarily due to development funding for Anthrasil.

Operating Expenses

Cost of Product Sales and Contract Manufacturing

For Q2 2015, cost of product sales and contract manufacturing was $27.3 million, a decrease of 21% as compared to 2014. The decrease was primarily attributable to the decrease in the BioThrax cost per dose sold associated with increased production yield in the period in which the doses were produced.

Research and Development
For Q2 2015, gross research and development (R&D) expenses were $40.9 million, an increase of 9% as compared to 2014. The increase was primarily attributable to additional R&D expenditures associated with product development programs in the Biodefense segment. Net R&D expenses, which are more representative of the company’s actual out-of-pocket investment in product development, are calculated as gross research and development expenses less contracts, grants and collaboration revenues. For Q2 2015, net R&D expenses were $5.7 million, a decrease of 61% as compared to 2014.

Selling, General and Administrative
For Q2 2015, selling, general and administrative expenses were $36.5 million, an increase of 19% as compared to 2014. The increase was primarily attributable to selling, general and administrative costs associated with the launch of IXINITY and professional services to support the company’s strategic growth initiatives.

Net Income
For Q2 2015, GAAP net income per diluted share is computed using the if-converted method. This method requires GAAP net income to be adjusted in the amount of $1.0 million, from $14.1 million to $15.1 million, related to interest expense and amortization of debt issuance cost, both net of tax, associated with the company’s 2.875% Convertible Senior Notes due 2021.
(II) Six Months Ended June 30, 2015 (unaudited)

Revenues

Product Sales
For the six months of 2015, product sales were $100.3 million, a decrease of 12% as compared to 2014. The decrease was primarily attributable to the timing of deliveries of BioThrax to the SNS due to our decision to suspend shipments to the CDC in Q1 2015. Shipments were subsequently resumed in Q2 2015.

Contract Manufacturing
For six months of 2015, revenue from our contract manufacturing operations was $21.1 million, an increase of 77% as compared to 2014. The increase was primarily due to the impact of fill/finish services revenues for the entire six month period in 2015.

Contracts, Grants and Collaborations
For six months of 2015, contracts, grants and collaborations revenue was $68.3 million, an increase of 78% as compared to 2014. The increase was primarily due to development funding for Anthrasil.

Operating Expenses
Cost of Product Sales and Contract Manufacturing
For the six months of 2015, cost of product sales and contract manufacturing was $46.0 million, a decrease of 14% as compared 2014. The decrease was primarily attributable to a decrease in product sales and contract manufacturing revenues.

Research and Development
For the six months of 2015, gross R&D expenses were $79.6 million, an increase of 18% as compared to 2014. The increase was primarily attributable to additional R&D expenditures in the Biodefense segment.

Net R&D expenses for the six months of 2015 were $11.3 million, a decrease of 62% as compared to 2014.

Selling, General and Administrative

For the six months of 2015, selling, general and administrative expenses were $70.9 million, an increase of 17% as compared to 2014. The increase was primarily attributable to additional post-acquisition selling, general and administrative costs largely associated with the operations acquired in Q1 2014, including IXINITY launch costs, as well as professional services to support the company’s strategic growth initiatives.

(III) Reconciliation of GAAP Net Income to Adjusted Net Income/(Loss), EBITDA and Adjusted EBITDA

This press release contains three financial measures (Adjusted Net Income/(Loss), EBITDA or earnings before interest, taxes, depreciation and amortization, and adjusted EBITDA) that are considered "non-GAAP" financial measures under applicable Securities & Exchange Commission rules and regulations. These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with generally accepted accounting principles. The company’s definition of these non-GAAP measures may differ from similarly titled measures used by others. Adjusted Net Income adjusts for specified items that can be highly variable or difficult to predict, or reflect the non-cash impact of charges resulting from purchase accounting. EBITDA reflects net income excluding the impact of depreciation, amortization, interest expense and provision for income taxes. Adjusted EBITDA also excludes specified items that can be highly variable and the non-cash impact of certain purchase accounting adjustments. The company views these non-GAAP financial measures as a means to facilitate management’s financial and operational decision-making, including evaluation of the company’s historical operating results and comparison to competitors’ operating results. These non-GAAP financial measures reflect an additional way of viewing aspects of the company’s operations that, when viewed with GAAP results and the reconciliations to the corresponding GAAP financial measure, may provide a more complete understanding of factors and trends affecting the company’s business.

The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the company’s reported results of operations, management strongly encourages investors to review the company’s consolidated financial statements and publicly filed reports in their entirety.

On August 6, 2015 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, reported its financial results for the second quarter ended June 30, 2015 (Press release, Curis, AUG 6, 2015, View Source [SID:1234507055]).

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"During the second quarter, we presented results of the Phase 1 trial of CUDC-907 at scientific conferences, where we reported clinical activity, including complete responses in heavily pre-treated patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL)," said Ali Fattaey, Ph.D., Curis’ President and Chief Executive Officer. "CUDC-907 appears to be well tolerated with a manageable side effect profile at the recommended dose and schedule. Enrollment of patients with relapsed or refractory DLBCL in the expansion arms of the ongoing Phase 1 study is continuing, where we are administering CUDC-907 either as monotherapy or in combination with rituximab. We are in the process of finalizing the Phase 2 study design for CUDC-907, and we expect to initiate the study later this year."

Dr. Fattaey continued, "Our partner Aurigene has made progress in advancing programs under our collaboration, and we remain on-track to file an IND application for the first immuno-oncology drug candidate later this year. We also expect to file an IND application for the lead IRAK4 inhibitor candidate and initiate its Phase 1 program during the first half of 2016."

Second Quarter and First Half 2015 Financial Results

Curis reported a net loss of $8.1 million, or ($0.06) per share on both a basic and fully diluted basis for the second quarter of 2015, as compared to a net loss of $1.9 million or ($0.02) per share on both a basic and fully diluted basis for the same period in 2014. Curis reported a net loss of $40 million, or ($0.34) per share on both a basic and fully diluted basis for the six months ended June 30, 2015, as compared to a net loss of $7.5 million or ($0.09) per share on both a basic and fully diluted basis for the same period in 2014. The net loss for the first half of 2015 includes an in-process research and development charge of $24.3 million related to Curis’ license agreement with Aurigene.

Revenues for the second quarter of 2015 were $2.1 million, as compared to $4.8 million for the same period in 2014. The decrease in revenues was primarily due to a decrease in license fee revenues due to a $3 million milestone payment that Curis earned from Genentech/Roche upon achievement by Genentech/Roche of certain development objectives during the second quarter of 2014. Offsetting these decreases, royalty revenues recorded on Genentech/Roche’s net sales of Erivedge increased to $2.0 million in the second quarter of 2015 as compared to $1.8 million during the same period in 2014.

Revenues for the six months ended June 30, 2015 were $3.7 million, as compared to $6.1 million for the same period in 2014.

Operating expenses for the second quarter of 2015 were $9.5 million, as compared to $6.3 million for the same period in 2014. Operating expenses for the six months ended June 30, 2015 were $42.1 million, as compared to $12.4 million for the same period in 2014 and were comprised of the following:

Costs of royalty revenues. Costs of royalty revenues, which are comprised of amounts due to third-party university patent licensors in connection with Genentech/Roche’s Erivedge net sales, were $103,000 and $92,000 during the second quarters of 2015 and 2014, respectively. Costs of royalty revenues for the six months ended June 30, 2015 were $187,000, as compared to $157,000 for the same period in 2014.

In-process research and development expenses. The Company recorded a one-time charge for in-process research and development expense of $24.3 million during the first half of 2015 associated with the issuance of 17,120,131 shares of Curis common stock to Aurigene as partial consideration for the rights granted under the terms of the parties’ January 2015 collaboration agreement.

Research and development expenses. Research and development expenses were $5.9 million for the second quarter of 2015 as compared to $3.3 million for the same period in 2014. The increase in research and development expense was primarily due to increased spending on CUDC-907 and preclinical programs under the Company’s collaboration with Aurigene. The Company incurred expenses of $2.7 million and $1.4 million on CUDC-907 for the quarters ended June 30, 2015 and 2014, respectively, related to its ongoing Phase 1 studies. Spending of $2.5 million on the Company’s preclinical research programs for the three months ended June 30, 2015 includes a $2 million milestone payment to Aurigene for selection of a third program under that collaboration and also includes costs to support planned development activities, primarily consisting of personnel costs, compared to costs of $81,000 in the prior year quarter. Offsetting these increases, spending on CUDC-427 decreased by $900,000 during the three months ended June 30, 2015 as compared to the prior year period. Research and development expenses were $10.7 million for the six months ended June 30, 2015 as compared to $6.5 million for the same period in 2014.

General and administrative expenses. General and administrative expenses were $3.4 million for the second quarter of 2015 as compared to $2.9 million for the second quarter of 2014. Increased legal costs and stock-based compensation were partially offset by decreased professional and consulting costs. General and administrative expenses were $6.9 million for the six months ended June 30, 2015 as compared to $5.8 million for the same period in 2014.

Other expense was $759,000 for the second quarter of 2015, as compared to $351,000 for the same period in 2014. Other expense primarily consisted of $843,000 and $950,000 in interest expense for the quarters ended June 30, 2015 and 2014, respectively, related to the loan made by BioPharma-II to Curis Royalty, a wholly-owned subsidiary of Curis. The Company also recorded other income of $557,000 and $649,000 during the three and six month periods ended June 30 2014, respectively, associated with the change in fair value of a warrant liability. Other expense was $1.6 million and $1.2 million for the six month periods ended June 30, 2015 and 2014, respectively.

As of June 30, 2015, Curis’ cash, cash equivalents, marketable securities and investments totaled $99.2 million, and there were approximately 128.4 million shares of common stock outstanding.

2015 Financial Guidance

The Company has revised its 2015 financial guidance for research and development expenses for 2015. The Company currently expects that these expenses will be in the range of $30 to $35 million for 2015. The Company had previously estimated that these expenses would range from $37 to $42 million. As a result, the Company currently expects to end 2015 with cash, cash equivalents and investments of $72 to $77 million versus its previous estimate of $65 to $70 million.

The Company’s decrease in research and development expenses is primarily the result of a decrease in estimated expenses across its development programs, including a recent re-evaluation of its clinical development plans for CUDC-427, an orally-available, small molecule antagonist of IAP proteins, as well as for its HSP90 inhibitor CUDC-305. The Company’s management determined that it would preserve Curis’ current resources for the continued development of CUDC-907 and drug candidates under the Company’s collaboration with Aurigene.

Recent Operational Highlights

CUDC-907:

In May 2015, Curis reported data from the dose escalation (completed) and expansion (ongoing) stages of the Phase 1 study of CUDC-907 at the Annual Meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) that was held in Chicago, IL. CUDC-907 demonstrated evidence of clinical activity with objective responses reported in patients with relapsed/refractory DLBCL and Hodgkin’s lymphoma. Among 10 response evaluable patients with DLBCL across various cohorts, two complete responses and four partial responses were reported. One patient with Hodgkin’s lymphoma experienced partial response out of a total of 12 response evaluable patients with Hodgkin’s lymphoma. In addition, stable disease was observed in 25 of 44 response evaluable patients across various lymphomas and multiple myeloma.
In June 2015, Curis presented data from the Phase 1 study of CUDC-907 at the 20th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), in Vienna, Austria, and the 13th International Congress on Malignant Lymphoma (ICML) in Lugano, Switzerland.
Aurigene Collaboration:

In April 2015, Aurigene presented a poster entitled "Novel IRAK4 inhibitors exhibit highly potent anti-proliferative activity in DLBCL cell lines with activating MYD88 L265P mutation" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2015 Annual Meeting. This poster included data from multiple orally bioavailable molecules that showed potent inhibition of IRAK4 kinase activity in biochemical assays and proliferation in DLBCL cancer cell lines with MYD88 mutation. Some of these compounds were further tested in in vivo models and demonstrated significant anti-tumor activity in a DLBCL xenograft model with MYD88 mutation as well as disease reduction in a rat collagen-induced arthritis model, which is a model for inflammatory conditions.
Upcoming Activities

Curis expects to present at the following investor conferences through October 2015:

Robert W. Baird & Co. 2015 Health Care Conference, September 9-10, 2015 in New York City
FBR 2nd Annual Healthcare Conference, September 9, 2015 in Boston, MA
14th Annual BIO Investor Forum, October 20-21, 2015 in San Francisco

On August 6, 2015 BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called AccurinsTM, reported financial results and business highlights for the second quarter ended June 30, 2015 (Press release, BIND Therapeutics, AUG 6, 2015, View Source [SID:1234507054]).

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"In the second quarter we made significant progress with our clinical programs and continued executing on our vision to develop new categories of Accurins that have a significant impact in multiple therapeutic areas," said Andrew Hirsch, president and chief executive officer of BIND Therapeutics. "We believe BIND-014, which is on track for an initial phase 2 data readout from the iNSITE 1 trial later this year, has the potential to have a meaningful impact on patients with multiple solid tumors types. We have also initiated programs that leverage the broad potential of our platform to develop Accurins that target new cell types and compartments with highly efficacious payloads and limited exposure to healthy tissue. We believe our innovative approach to develop new categories of Accurins can fundamentally change how diseases are treated."

During the quarter, BIND advanced its product development pipeline with continued strong enrollment of the KRAS mutant and squamous histology cohorts in the iNSITE 1 non-small cell lung cancer trial with BIND-014. The Company also initiated site activation in the iNSITE 2 trial in patients with four orphan tumor histologies: cholangiocarcinoma, advanced cervical cancer, advanced bladder cancer, and advanced squamous cancer of the head and neck. First patient dosing in the iNSITE 2 trial is anticipated in the third quarter of 2015.

Additionally, BIND’s collaborator AstraZeneca filed an investigational new drug application (IND) and received clearance to begin a phase 1 trial with AZD-2811, a novel Aurora B kinase inhibitor that will be the second Accurin to enter the clinic. BIND and AstraZeneca expect the patient enrollment in this trial to begin in the fourth quarter of 2015. Under the terms of its agreement with AstraZeneca, BIND will earn a $4 million milestone payment upon first dosing a patient in a phase 1 clinical trial with AZD-2811.

"We are making great progress with our BIND-014 clinical program and enrollment for both cohorts of iNSITE 1 is proceeding as planned and fully meeting our expectations," said Hagop Youssoufian, M.Sc., M.D., chief medical officer at BIND. "We are also excited to enroll the first patient in the iNSITE 2 trial with BIND-014, an important milestone considering the signals of clinical efficacy we saw in our phase 1 trial in patients with cholagio, cervical and head and neck cancers. BIND-014 has the potential to become an effective new therapy that both improves the treatment experience and offers greater efficacy for patients with multiple tumor types who currently have limited options."

BIND previously announced efforts to develop new categories of Accurins that can be applied to multiple therapeutic areas. During the second quarter of 2015, the Company initiated early formulation work to engineer new Accurin product concepts containing anti-infectives and oligonucleotides. These programs leverage the ability of the Accurin platform to target promising payloads to diseased cells and tissues types that have been challenging to treat with conventional therapies.

BIND also entered into a research collaboration with Macrophage Therapeutics to combine their Manocept platform, which targets the CD206 receptor on disease-associated macrophages, with BIND’s Accurin platform. Activated macrophages play an important role in the tumor microenvironment and other diseases and the goal of the collaboration is to target Accurins to CD206 disease-associated macrophages in the tumor microenvironment.

"Our collaboration with Navidea’s Macrophage Therapeutics is a result of our efforts to develop Accurins that incorporate novel APIs and ligands that target important pathways in additional therapeutic areas," continued Hirsch. "This collaboration could result in Accurins that are able to selectively bind to CD206 positive disease-associated macrophages, which help create an immunosuppressive tumor environment for many types of cancers. In addition to a potentially innovative approach in oncology, this collaboration could result in Accurins that provide new treatments across a broad array of diseases that trigger the activation of disease-associated macrophages, including infectious disease, autoimmune and CNS diseases."

Anticipated upcoming milestones include:

Initial data readouts in the fourth quarter of 2015 from the iNSITE1 trial in KRAS mutant and squamous histology non-small cell lung cancer, which we expect to provide the evidence needed to determine the most appropriate regulatory path to market.
Dose first patient in the iNSITE 2 clinical trial in multiple solid tumors in the third quarter of 2015.
Report overall survival data from the completed phase 2 non-small cell lung cancer study with BIND-014 in the broader patient population following occurrence of all survival events.

Report final results from the phase 2 prostate cancer study with BIND-014 following occurrence of 75 percent of the survival events.

Dose first patient in phase 1 clinical trial with AZD-2811 (with collaborator AstraZeneca) in the fourth quarter of 2015.
Potential selection of Accurin candidate in BIND’s collaboration with Pfizer in September 2015.
Report the results of our proof-of-concept work with Macrophage Therapeutics before December 31, 2015.
Continue advancing BIND-510 through important preclinical studies to position it for an IND filing in 2016.

Second Quarter 2015 Financial Results

Revenue for the second quarter of 2015 increased three percent to $2.5 million compared to the second quarter of 2014. Revenue primarily represents BIND’s reimbursable research and development expenses and collaboration up-front license fees and milestones for which revenue recognition was initially deferred and is being recognized over the performance period from BIND’s collaborations with AstraZeneca and Pfizer.

The increase in revenue from the 2014 period to the 2015 period was primarily due to total revenue recognized under the Pfizer collaboration reflecting completion of the majority of BIND’s activities before Pfizer’s first option decision in September 2015, as well as higher revenue under the AstraZeneca collaboration for increased manufacturing activities in support of the IND filing and the first-in-human clinical trials. AstraZeneca anticipates enrolling the first patient in a AZD-2811 phase 1 clinical trial in the fourth quarter of 2015, which will trigger BIND earning a $4 million milestone under its collaboration agreement with AstraZeneca. Revenue during the second quarter of 2014 included recognition of the remaining up-front license fee from the Amgen collaboration as a result of its completion.

Research and development expenses totaled $8.3 million for the second quarter of 2015, compared to $6.9 million for the second quarter of 2014. The increase was primarily driven by headcount growth to support the advancement of BIND’s internal pipeline and collaborations, as well as higher expenses as the Company scales up its clinical material manufacturing capability under our AstraZeneca collaboration.

General and administrative expenses totaled $4.4 million for the second quarter of 2015, compared to $3.8 million for the second quarter of 2014. The increase was primarily driven by general and administrative headcount growth related to compensation, including stock-based expenses.

Net loss for the second quarter of 2015 was $10.5 million, compared to a net loss of $8.4 million for the second quarter of 2014.

Cash, cash equivalents and short-term investments were approximately $53 million as of June 30, 2015. The Company expects that its cash, cash equivalents and short-term investments as of June 30, 2015 will fund operating expense and capital expenditure requirements into the third quarter of 2016. This expectation is based on the Company’s current operating plans and research and development funding that it expects to receive under its existing collaborations, but excludes any potential milestone payments.