On November 10, 2016 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported financial results for the quarter and nine month period ended September 30, 2016 and provided an update on its development programs for ThermoDox, the Company’s proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA-based immunotherapy (Press release, Celsion, NOV 10, 2016, View Source [SID1234516538]).

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"Over the last nine months, we have realized meaningful progress with respect to our two lead programs, ThermoDox and GEN-1. Importantly, we are well positioned to sustain this momentum through the balance of 2016 and beyond," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "The initial data from our GEN-1 program provides highly valuable insights into its favorable clinical and safety profile indicating a great deal of potential in both first and second-line ovarian cancer, and we look forward to reporting additional data from our ongoing OVATION study before year-end."

Mr. Tardugno continued, "Our ongoing global, pivotal Phase III OPTIMA Study of ThermoDox in primary liver cancer remains on track with clinical sites currently enrolling patients in 13 countries worldwide. Investigators continue to recognize the value of findings from the HEAT Study and their continued interest reinforces substantial and mounting support for the OPTIMA Study.

The recent independent analysis conducted by the National Institutes of Health provides further confirmatory support indicating that the use of radiofrequency ablation (RFA) for more than 45 minutes in patients treated with ThermoDox can have a correlative impact on reductions in tumor size and overall survival in patients with primary liver cancer."

Recent Developments
Immunotherapy – GEN-1

Announced Positive Data from the First Two Cohorts of the OVATION Study. In July 2016, the Company announced data from the second cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1 with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. In the first six patients dosed, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult-to-treat cancer. The efficacy data included highly encouraging tumor response rates, successful surgical resections of the eligible patients’ tumors, impressive pathological responses and dramatic, clinically meaningful drops in CA-125 protein levels.

Positive DSMB Review of OVATION Study in Ovarian Cancer. In September 2016, the independent Data Safety Monitoring Board (DSMB) completed its safety review of data from the first three patient cohorts in the ongoing Phase Ib OVATION Study. Based on the DSMB’s recommendation, the study will continue as planned and the Company will proceed with dosing in its fourth and final patient cohort at an escalated dose. Celsion expects the fourth cohort to be fully enrolled this year.

Established a Manufacturing and Commercial Supply Agreement with Hisun for GEN-1. In August 2016, Celsion signed a long term technology transfer, manufacturing and commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. The agreement relates to both the clinical and commercial manufacture and supply of GEN-1 for the greater China territory, with the option to expand into other countries in the rest of the world after all necessary regulatory approvals are in effect. With highly cost effective pricing, the agreement will support economically advantaged supply for ongoing and planned clinical studies in the United States and potential future studies of GEN-1 in China as well as Europe.

Chemotherapy – ThermoDox
Announced the Final Overall Survival Data from HEAT Study of ThermoDox in Primary Liver Cancer. In August 2016, the Company announced updated results from its final retrospective analysis of the 701-patient HEAT Study. The overall survival analysis demonstrated that in a large, well bounded, subgroup of 285 patients (41% of the HEAT Study patients), treatment with a combination of ThermoDox and optimized RFA provided an average 54% risk improvement in overall survival compared to optimized RFA alone. The Hazard Ratio (HR) at this analysis is 0.65 (95% CI 0.45 – 0.94) with a p-value of 0.02. Importantly, after 3.5 years of follow up, the median overall survival for the ThermoDox group has yet to be reached and is showing over 80 months survival benefit compared to less than 60 months projection for the optimized RFA only group, which translates into a two year survival benefit.

Announced the Independent NIH Analysis Showing Treatment with ThermoDox Plus RFA may Significantly Improve Overall Survival of Patients with Primary Liver Cancer. In September 2016, the Company announced that the National Institutes of Health (NIH) has conducted an independent retrospective analysis of data from the Company’s HEAT Study. The NIH analysis, which sought to evaluate the correlation between RFA burn time per tumor volume (min/ml) and clinical outcome in patients treated with ThermoDox, concluded that increased RFA burn time per tumor volume substantially improved survival in patients with solitary lesions treated with RFA + ThermoDox compared to patients treated with RFA alone. These findings are consistent with Celsion’s analysis of the HEAT Study data showing that in patients treated with RFA for more than 45 minutes, standardized RFA plus ThermoDox resulted in a statistically significant improvement in overall survival of over two years when compared to standardized RFA alone.

Detailed findings from the NIH study will be presented during oral sessions on Monday, November 28, 2016 at 1:50 pm CT during the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) to be held on November 26 – December 2, 2016 in Chicago, IL.

Announced Presentations Highlighting Phase III OPTIMA Study at Two Asia-Pacific Primary Liver Cancer Expert Meetings.
In July 2016, the Company announced that its ongoing Phase III OPTIMA trial evaluating ThermoDox in primary liver cancer was featured during an oral presentation at the 7th Asia-Pacific Primary Liver Cancer Expert (APPLE) Meeting in Hong Kong, China. The presentation highlighted the potential of ThermoDox plus optimized RFA to significantly improve overall survival of newly diagnosed patients.

In October 2016, the Company announced the presentation of data from the Company’s HEAT Study, highlighting the curative potential for ThermoDox plus optimized RFA in intermediate primary liver cancer at the 3rd Asian Conference on Tumor Ablation (ACTA) in Seoul, Korea.

Announced Collaboration with the Children’s Research Institute to Evaluate the Use of ThermoDox and High Intensity Focused Ultrasound in the Treatment of Solid Tumors in Children and Young Adults. In October 2016, the Company announced a collaboration with the Children’s Research Institute to conduct a clinical study of ThermoDox in combination with magnetic resonance-guided high intensity focused ultrasound to treat relapsed or refractory solid tumors in children and young adults. This investigator-sponsored Phase I clinical study is being partially funded by the National Institutes of Health and is expected to commence in the fourth quarter of 2016.

Financial Results
For the quarter ended September 30, 2016, Celsion reported a net loss of $6.4 million, or $(0.23) per share, compared to a net loss of $4.3 million, or $(0.19) per share, in the same period of 2015. Operating expenses were $5.7 million in the third quarter of 2016 compared to $4.4 million in the same period of 2015. For the nine month period ended September 30, 2016, the Company reported a net loss of $16.7 million, or $(0.66) per share, compared to $16.9 million, or $(0.79) per share, in the same nine month period of 2015. Operating expenses were $15.9 million in the first nine months of 2016 compared to $16.3 million in the same period of 2015. Net cash used in operations was $13.7 million in the first nine months of 2016 compared to $16.9 million in the same period last year. The Company ended the third quarter of 2016 with $8.7 million of total cash, investments and accrued interest on these investments, which included the proceeds of a $6 million registered direct offering completed during the second quarter.

Research and development costs were $4.2 million in the third quarter of 2016 compared to $2.9 million in the same period last year. Research and development costs were $11.0 million in the first nine months of 2016 and 2015. R&D costs in 2016 reflect lower clinical supply costs for the ThermoDox and GEN-1 clinical studies offset by increased costs associated with the enrollment in the OPTIMA and the OVATION studies when compared to 2015. General and administrative expenses were $1.5 million in the third quarter of 2016 and 2015. General and administrative expenses were $4.9 million in the first nine months of 2016, down 8 percent when compared to the same period of 2015. This decrease was primarily the result of lower personnel related costs and professional fees.

Akebia has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Akebia, 2017, NOV 9, 2016, View Source [SID1234521574]).

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On November 9, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the three months ended September 30, 2016, and provided an overview of recent corporate developments and upcoming milestones for its research and development programs (Press release, CytRx, NOV 9, 2016, View Source;p=RssLanding&cat=news&id=2220972 [SID1234516514]).

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"This month we expect to report additional data from our pivotal, global Phase 3 clinical trial of aldoxorubicin in patients with second-line soft tissue sarcomas (STS)," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "We then plan to schedule a pre-NDA meeting with the FDA. Additionally, we recently completed enrollment in the aldoxorubicin Phase 2b clinical trial in second-line small cell lung cancer in September. We now estimate that top-line results will be available in the first half of 2017 as the number of progression events has not yet been reached."

Third Quarter 2016 and Recent Developments

Presented Positive Aldoxorubicin Combination Clinical Trial Results at ESMO (Free ESMO Whitepaper) 2016. On October 10, 2016, CytRx presented a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress featuring interim clinical data from its on-going clinical trial of aldoxorubicin in combination with ifosfamide and mesna in patients with soft tissue sarcomas. Of 36 evaluable patients, 13 of 36 (36%) achieved a partial response of the target lesion by RECIST 1.1 criteria, 22 of 36 (61%) had stable disease, and one patient had progressive disease. Median progression-free survival has not yet been reached. While the combination did have certain toxicities, none were treatment-limiting.

Completed enrollment in its Global Phase 2b Clinical Trial in Second-Line Small Cell Lung Cancer. On September 6, 2016, CytRx announced that it completed enrollment in its global, randomized Phase 2b clinical trial comparing aldoxorubicin to topotecan in 135 patients with small cell lung cancer (SCLC) who have progressed or relapsed to prior chemotherapy. The primary endpoint is progression-free survival. The number of progression events has not yet been reached, and CytRx currently expects to announce top-line data in the first half of 2017.

Strengthened the Balance Sheet with an Equity Financing. On July 20, 2016, CytRx completed a public offering of common stock and one-year warrants for total net proceeds of aproximately $18.3 million. If exercised in full, the warrants would provide up to an additional $20 million in capital.

Reported Initial Analysis of its Pivotal, Global Phase 3 Aldoxorubicin Trial in STS. On July 11, 2016, CytRx reported interim results from its global, randomized, Phase 3 clinical trial of aldoxorubicin compared to investigator’s choice therapy in patients with relapsed or refractory STS. The Company also previously announced that it expects to report additional data from the trial in the fourth quarter. Following the subsequent analysis, CytRx plans to schedule a pre-NDA meeting with the FDA to seek marketing approval. In addition, patients in the Phase 3 clinical trial continue to be followed for overall survival, a secondary endpoint of the trial.

Capital Conservation. During the third quarter, CytRx embarked on a plan to reduce spending until additional results from the aldoxorubicin Phase 3 STS clinical trial are available and the Company meets with the FDA. This included reducing headcount, stopping pre-commercialization activities for aldoxorubicin and suspending further development of DK049.

Pipeline Generation Activities. CytRx’s expanded its drug discovery efforts to create a pipeline of oncology candidates utilizing the Company’s LADRTM technology to attach ultra-high potency drugs to albumin (10-1000 times more potent than traditional chemotherapies limited to antibodies only) to target tumors.

Upcoming Milestones

Present interim data from the on-going Phase 1b/2 clinical trial of aldoxorubicin in combination with ifosfamide/mesna at the Connective Tissue Oncology Society (CTOS) Annual Meeting being held on November 9-12, 2016, in Lisbon, Portugal.
Announce additional data from CytRx’s pivotal, global Phase 3 clinical trial of aldoxorubicin in patients with second-line STS in November 2016.
Report top-line results from the global Phase 2b clinical trial evaluating aldoxorubicin versus topotecan in patients with second-line SCLC in the first half of 2017.
Schedule and hold a pre-NDA meeting with the FDA regarding aldoxorubicin as a treatment for patients with relapsed or refractory advanced STS.
Third Quarter 2016 Financial Results

CytRx reported cash and cash equivalents of $58.9 million as of September 30, 2016.

Net loss for the quarter ended September 30, 2016 was $12.2 million, or $0.13 per share, compared with a net loss of $7.1 million, or $0.11 per share, for the quarter ended September 30, 2015. During the third quarter of 2016, CytRx recognized a non-cash gain on warrant derivative liability of $0.2 million, compared to a non-cash gain of $3.5 million for the three-month period ended September 30, 2015.

Research and development (R&D) expenses were $8.9 million for the third quarter of 2016, and included development expenses of $6.7 million for the aldoxorubicin program. R&D expenses were $8.5 million for the third quarter of 2015.

General and administrative (G&A) expenses were $2.8 million for the third quarter of 2016, compared to $2.2 million for the third quarter of 2015. G&A expenses for the third quarter 2016 included non-cash employee stock-compensation expense of $0.6 million, compared to $0.5 million for the same period in 2015.

On November 9, 2016 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported financial results for the quarter ended September 30, 2016 (Press release, Inovio, NOV 9, 2016, View Source [SID1234516542]). The following financial results provide a year-over-year comparison of the third quarter in 2016 and 2015. Total revenue was $12.5 million compared to $24.2 million. Total operating expenses were $32.7 million compared to $20.5 million. The net loss attributable to common stockholders was $20.8 million, or $0.28 per share for the third quarter 2016, compared to net income of $5.6 million, or $0.08 per share in the third quarter of 2015.

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Revenue

The decrease in revenue for the comparable periods was primarily due to $15.0 million of revenue recognized in the third quarter 2015 from the up-front payment received from our partnership agreement with MedImmune. Accounting recognition of the remainder of the $27.5 million upfront payment was deferred and will be triggered by future events. The net income achieved during the third quarter 2015 was attributable to the increase in revenue and may not repeat in future quarters.

Operating Expenses

Research and development expenses were $27.0 million compared to $16.1 million for the third quarter ending 2016 and 2015 respectively. The increase was primarily related to increased investment in our product development programs – notably the DARPA funded Ebola program and clinical trial preparations for the initiation of the VGX-3100 phase III study. General and administrative expenses were $5.8 million compared to $4.4 million.

Capital Resources

As of September 30, 2016, cash and cash equivalents and short-term investments were $119.7 million compared with $163.0 million as of December 31, 2015. There were 74.0 million shares outstanding and 81.8 million fully diluted.

During the three months ended September 30, 2016, the Company sold 448,848 shares of common stock under its ATM common stock sales agreement for net proceeds of $4.2 million, with an average price of $9.45 per share.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q providing the complete 2016 Third quarter financial report can be found at: View Source

Corporate Update

Clinical Development

The U.S. Food and Drug Administration (FDA) requested additional information regarding Inovio’s submission for its proposed phase III clinical program for VGX-3100, placing the program on clinical hold. The study had not yet been initiated and has not enrolled or dosed subjects. In its initial communication the FDA requested additional data to support Inovio’s shelf-life claim for the single-use disposable array of the newly designed and manufactured CELLECTRA 5PSP immunotherapy delivery device. Inovio expects to receive a formal letter in November, which may request other information, and estimates the start of the phase III clinical program will be delayed until the first half of 2017, pending resolution of the FDA’s request. This clinical hold does not affect other Inovio clinical programs.
Initiated a phase I Zika DNA vaccine trial in Puerto Rico to test for safety, immune responses and initial evidence of efficacy. The placebo-controlled double-blind trial will assess differences in Zika infection rates in 160 healthy participants given either placebo or vaccine as part of an exploratory endpoint. This is the second human Zika vaccine trial initiated by Inovio. All 40 subjects for the first clinical study have been fully enrolled and dosed.
Expanded phase I Ebola vaccine trial by fully enrolling an additional 125 subjects in a second stage after generating positive initial safety and immune response data in the first set of 75 healthy volunteers. The study will assess immune response characteristics generated with fewer intradermal administrations, lower doses, and with and without its DNA-based IL-12 immune activator.
Corporate Development

Inovio incorporated a 100%-owned subsidiary, GENEOS Therapeutics, Inc., to develop and commercialize neo-antigen based personalized cancer therapies. While Inovio pursues the unique potential of its SynCon immunotherapy design to break tolerance and create cancer products targeting universal tumor specific antigens, GENEOS will exclusively focus on leveraging Inovio’s potent DNA immunotherapy technology platform to advance the emerging field of patient-specific neo-antigen therapies. Inovio’s clinically validated DNA based platform is well suited for advancing individualized therapies due to its rapid product design and manufacturing benefits, ability to combine multiple neo-antigens into formulations, and generation of potent killer T cell responses that are needed to drive clinical efficacy. GENEOS plans to independently raise capital and build a team to execute this complementary business model. Inovio will continue its focus on advancing its universal antigen-specific cancer immunotherapy portfolio, including INO-3112 (with Medimmune), INO-5150, INO-1400, and INO-5401, as well as its pre-cancer (VGX-3100) and infectious disease products.
Licensed a veterinary vaccine for foot and mouth disease (FMD) to Plumbline Life Sciences, an animal health company headquartered in South Korea. Plumbline will fund all development activities for this FMD vaccine and pay Inovio milestone payments as well as royalties on potential product sales.
Inovio expanded its leadership team with the appointment of multiple individuals to lead the functions of business development, biologic and device manufacturing, regulatory, and oncology clinical development.

On November 9, 2016 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported results for its first quarter ended September 30, 2016 (Press release, MEI Pharma, NOV 9, 2016, View Source [SID1234516663]). The Company also highlighted recent progress with its pipeline of drug candidates and previewed upcoming data presentations.

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"The past quarter was one of unprecedented achievement for the company, highlighted by the receipt of Breakthrough Therapy Designation and a global strategic partnership for Pracinostat," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "Now we approach the end of the calendar year in a position of significant strength, armed with a fully funded Phase III program, a pipeline of drug candidates advancing in the clinic and a healthy cash position that affords us the ability to not only execute our clinical development plan, but also to enhance our pipeline with the right opportunity."

Pipeline Update

Strategic partnership for development and commercialization of Pracinostat. In August 2016, the Company entered into an exclusive licensing, development and commercialization agreement with Helsinn Healthcare, SA, a Swiss pharmaceutical corporation, for Pracinostat, an investigational agent currently being evaluated in clinical studies for acute myeloid leukemia (AML) and other potential indications. Under the terms of the agreement, Helsinn is granted a worldwide exclusive license to Pracinostat and is responsible for funding its global development and commercialization. As compensation, MEI Pharma will receive near-term payments of $20 million, including a $15 million upfront payment and a $5 million payment upon the earlier of (i) dosing of the first patient in the upcoming Phase III study of Pracinostat in newly diagnosed AML patients unfit to receive induction therapy, or (ii) March 1, 2017. In addition, MEI Pharma will be eligible to receive up to $444 million in potential regulatory and sales-based milestones, along with royalty payments on the net sales of Pracinostat. In a related transaction, Helsinn made a $5 million equity investment in MEI Pharma.
Dose-optimization study of Pracinostat plus azacitidine in high-risk MDS. As part of the license, development and commercialization agreement, the Company will work with Helsinn to determine an optimal dosing regimen of Pracinostat in combination with azacitidine for the treatment of high and very high risk myelodysplastic syndrome (MDS). Based on its clinical experience with the combination, the Company believes that an optimized dose may improve tolerability in this population, which in turn could result in increased efficacy of the combination vs. azacitidine alone. MEI Pharma will be responsible for the conduct of the study and Helsinn will share the cost. The study is anticipated to commence in the first half of calendar year 2017.
Breakthrough Therapy Designation from U.S. Food and Drug Administration (FDA). In August 2016, the Company announced that the FDA granted Breakthrough Therapy Designation for Pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy. According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. In addition, the Company announced that agreement has been reached with the FDA on the proposed Phase III AML study design.
Phase Ib study of PI3K delta inhibitor ME-401 open for enrollment. In September 2016, the Company’s Phase 1b clinical study of ME-401 in patients with relapsed refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or follicular lymphoma was opened for enrollment. ME-401 is a potent and highly selective oral PI3K delta inhibitor with the potential for a wide therapeutic window that may lead to safer treatment options, including combination treatment options, for patients with lymphomas. This study will allow the Company to study the safety and tolerability of ME-401 over time as it seeks to identify an optimal dose for future Phase 2 studies. Interim data from the study is expected by the middle of calendar year 2017.
Investigator-sponsored study of mitochondrial inhibitor ME-344 open for enrollment. In August 2016, an investigator-sponsored study of ME-344 in combination with the vascular endothelial growth factor (VEGF) inhibitor bevacizumab (marketed as Avastin) in patients with HER2-negative breast cancer was opened for enrollment. The study is being conducted in collaboration with the Spanish National Cancer Research Centre in Madrid. Pre-clinical data from the collaboration showed substantially enhanced anti-tumor activity of ME-344 in cancer cells when combined with VEGF inhibitors due to a disruption of both mitochondrial and glycolytic metabolism. Data from the investigator-sponsored study are expected by the end of calendar year 2017.
Upcoming Data Presentations

Long-term survival and response data from Phase II study of Pracinostat in AML. Data from a multi-center Phase II clinical study of Pracinostat and azacitidine in older patients with AML who are not eligible for induction chemotherapy have been selected for oral presentation at the upcoming ASH (Free ASH Whitepaper) Annual Meeting in San Diego on December 3, 2016. The presentation by principal investigator Dr. Guillermo Garcia-Manero, MD Anderson Cancer Center, is expected to highlight the durable responses and long-term survival benefit achieved in this investigational study, which appeared to compare favorably to azacitidine alone in a recent international Phase III study (AZA-AML-001). Pracinostat is an investigational agent and is not approved for use in the U.S.
Exposure data from clinical study of ME-401 supporting wide therapeutic window. Additional data from a first-in-human clinical study of ME-401 in healthy volunteers will be presented at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting in Denver on November 15, 2016. The presentation will highlight formulation selection and development for ME-401, including exposure margins based on clinical data and preclinical toxicity supporting the potential for an improved therapeutic window from repeated dosing compared to the approved PI3K delta inhibitor idelalisib (marketed as Zydelig).
Financial Highlights

As of September 30, 2016, MEI Pharma had $58.9 million in cash, cash equivalents and short-term investments, which the Company believes will be sufficient to fund operations through at least calendar year 2017.
Net loss was $4.3 million, or $0.12 per share, for the three months ended September 30, 2016, compared to $5.7 million, or $0.17 per share, for the previous quarter, and $4.6 million, or $0.13 per share for the same period in 2015.
Research and development expenses were $1.6 million for the three months ended September 30, 2016, compared to $2.8 million for the same period in 2015. The decrease was primarily due to a reduction in clinical trial expenses for Pracinostat and ME-344.
General and administrative expenses were $2.7 million for the three months ended September 30, 2016, compared to $1.8 million for the same period in 2015. The increase was primarily due to professional service costs associated with the Helsinn license agreement.