10-Q – Quarterly report [Sections 13 or 15(d)]

Champions Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Pfizer and Astellas Announce Top-Line Results from Phase 4 PLATO Trial of XTANDI® (enzalutamide) Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer

On December 14, 2016 Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503) reported the Phase 4 PLATO study, evaluating the efficacy and safety of continued treatment with XTANDI (enzalutamide), plus abiraterone acetate and prednisone as compared to treatment with abiraterone acetate and prednisone alone, did not meet its primary endpoint of improvement in progression-free survival (PFS) in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (CRPC) whose prostate-specific antigen (PSA) has previously progressed on XTANDI (Press release, Pfizer, DEC 14, 2016, View Source [SID1234517076]).

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"While the PLATO trial did not meet its primary endpoint, it is critical that we continue to focus on addressing the unmet needs of men with metastatic CRPC, who have a poor prognosis despite treatment advances," said Mohammad Hirmand, M.D., interim chief medical officer at Medivation, Inc., which is now part of Pfizer. "We will continue to analyze these data to better understand the results with the goal of further helping these patients."

understand the results with the goal of further helping these patients."

"XTANDI continues to remain an important treatment option for men with metastatic CRPC and their physicians. We are committed to continuing to explore the clinical potential of XTANDI across the disease continuum," said Steven Benner, M.D., senior vice president, therapeutic area head for oncology development, Astellas.

XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castrate-resistant prostate cancer (CRPC), based on clinical studies showing statistically significant overall survival benefit versus placebo.

About PLATO

The Phase 4 PLATO trial (NCT01995513) is a global randomized, double-blind, placebo-controlled, two-period study designed to evaluate the efficacy and safety of continued treatment with XTANDI plus abiraterone acetate and prednisone at the time of confirmed PSA progression, as compared to treatment with abiraterone acetate and prednisone alone at the time of PSA progression. The study enrolled 509 patients with chemotherapy-naïve metastatic CRPC who received open label XTANDI during period 1 of the study, until PSA progression was confirmed. Eligible patients were then randomized to one of the two treatments and assessed for the primary endpoint of the study, PFS, defined by either: 1) radiographic progression or 2) unequivocal clinical progression or 3) death during the study.

Period 1 patients were treated with XTANDI 160mg/day orally and period 2 patients were treated with blinded XTANDI 160 mg/day orally in combination with abiraterone at a dose of 1,000 mg/day administered orally and prednisone at a dose of 5 mg administered orally twice daily, versus placebo plus the same doses of abiraterone acetate and prednisone.

For additional information regarding the PLATO trial, visit clinicaltrials.gov (link is external).

About Metastatic Castration-Resistant Prostate Cancer (CRPC)

Metastatic castration-resistant prostate cancer (CRPC) refers to prostate cancer that has spread to parts of the body other than the prostate, and continues to spread despite treatment.1 Up to 40 percent of men diagnosed with prostate cancer who undergo therapy develop metastatic, or advanced, prostate cancer.2 In the U.S., the five-year relative survival rate for prostate cancer patients with metastatic disease is 28 percent, compared with 100 percent for prostate cancer patients with non-metastatic disease.3

About XTANDI (enzalutamide) capsules

XTANDI (enzalutamide) is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this mechanism of action (MOA) is unknown.

XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

Important Safety Information

Contraindications

XTANDI is not indicated for women. XTANDI can cause fetal harm and potential loss of pregnancy.

Warnings and Precautions

Seizure occurred in 0.5% of patients receiving XTANDI in clinical studies. In placebo-controlled studies, 8 of 1671 (0.5%) patients treated with XTANDI and 1 of 1243 (0.1%) patients treated with placebo experienced a seizure. In patients who previously received docetaxel, 7 of 800 (0.9%) patients treated with XTANDI experienced a seizure and no patients treated with placebo experienced a seizure. In a placebo-controlled study in chemotherapy-naïve patients, 1 of 871 (0.1%) treated with XTANDI and 1 of 844 (0.1%) patients treated with placebo experienced a seizure. In bicalutamide-controlled studies conducted in chemotherapy-naïve patients, 3 of 380 (0.8%) patients treated with XTANDI and 1 of 387 (0.3%) patients treated with bicalutamide experienced a seizure. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Adverse Reactions

The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI patients from the two placebo-controlled clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. In the bicalutamide-controlled study of chemotherapy naïve patients, the most common adverse reactions (≥ 10%) reported in XTANDI patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, upper respiratory tract infection, diarrhea, and weight loss.

In the study of patients taking XTANDI who previously received docetaxel, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In the placebo-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups. In the bicalutamide-controlled study of chemotherapy naïve patients, Grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients and 37.6% of bicalutamide patients. Discontinuations due to adverse events were reported for 7.6% of XTANDI patients and 6.3% of bicalutamide patients.

Lab Abnormalities: In the two placebo-controlled trials Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).

Infections: In a study of patients taking XTANDI who previously received docetaxel, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In the placebo-controlled study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death.

Falls (including fall-related injuries) occurred in 9% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.

Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of all patients in each arm.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI.

Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.

Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

Please see Full Prescribing Information at View Source (link is external) for additional safety information.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch (link is external) or call 1-800-FDA-1088.

Genocea R&D Day Highlighted Lead Program, GEN-003, for the Treatment of Genital Herpes and Introduced Immuno-Oncology Programs & Strategy

On December 14, 2016 Genocea Biosciences, Inc. (NASDAQ:GNCA), a company developing T cell-directed vaccines and immunotherapies reported that it held its first R&D day for investors and analysts today (Press release, Genocea Biosciences, DEC 14, 2016, View Source [SID1234517075]). The company highlighted its lead program, GEN-003, a T cell-directed immunotherapy for the treatment of genital herpes infections for which six-month Phase 2b placebo-controlled clinical efficacy is expected in January 2017. The Company also introduced its immuno-oncology strategy, including its plans to file an IND for a neoantigen cancer vaccine in 2017 and announced new research collaborations with Checkmate Pharmaceuticals, Inc. (Checkmate) and US Oncology Research.

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"Genocea is a leader in the development of innovative therapies at the forefront of the T cell revolution with GEN-003 for genital herpes and our emerging work in immuno-oncology," said Chip Clark, president and chief executive officer of Genocea. "We believe that ATLASTM, our T cell antigen discovery platform, that is the basis of our clinical success to date in infectious diseases, is ideally suited to advance the understanding of the role T cells play in killing cancer. Our confidence in our immuno-oncology programs is strengthened by the collaborations we announced today, which reflect broad interest in our unique ability to comprehensively profile a person’s actual T cell responses to cancer."

GEN-003 Program Highlights

Today, Genocea highlighted the significant body of clinical data it has generated over the course of three clinical trials for what may be the first new therapy for genital herpes in more than 20 years. GEN-003 is a first-in-class T cell-directed immunotherapy designed to elicit both a T cell and B cell immune response to antigens prioritized using the ATLAS platform. Genocea’s ATLAS platform profiled the comprehensive spectrum of actual T cell responses mounted by humans in response to their genital herpes disease to identify the antigen targets that drove protective T cell responses.

Based on clinical data to date, as well as market research showing the significant dissatisfaction among patients with current treatment options for genital herpes, GEN-003 may offer patients an important new treatment option with the promise of improved ‘real-world’ clinical outcomes and sustained reductions in viral shedding with the convenience of annual maintenance dosing. The Company expects to report six-month clinical efficacy data from its ongoing Phase 2b placebo-controlled trial in January 2017.

Guest speaker Nicholas Van Wagoner, M.D., Ph.D., Assistant Professor, Division of Infectious Diseases at the University of Alabama, Birmingham , School of Medicine provided an overview of the disease and reviewed the current treatment approach for genital herpes and affirmed his belief that a product with the profile of GEN-003 could create a much-needed additional treatment option for patients and physicians.

Genocea also today for the first time presented the results of extensive new market research based on GEN-003’s demonstrated clinical profile, suggesting that patients, physicians and payers all view GEN-003 favorably. Mr. Clark presented data demonstrating the Company’s belief that GEN-003 could have upwards of $2 billion global revenue potential if successfully developed worldwide.

Immuno-Oncology Program Highlights

Guest speaker Charles G. Drake, M.D., Ph.D., Director of GU Medical Oncology, Co-Director: Immunotherapy Program, Associate Director for Clinical Research, and Professor of Oncology and Immunology at the Herbert Irving Cancer Center at Columbia University, provided an overview of immunotherapy in cancer. His presentation reviewed the progress made in treating cancer with checkpoint inhibitors and the opportunity to further improve clinical outcomes, including through a better understanding of which patients will benefit from existing therapies and combining checkpoint inhibitors with cancer vaccines.

A Genocea presentation followed, introducing its immuno-oncology strategy and highlighting the unique ability of its ATLAS platform to comprehensively elucidate the T cell responses that patients make to cancers.

This capability is currently being applied to profiling T cell responses of patients who are treated with checkpoint inhibitors and other immune modulators, with the goal of finding signatures of T cell response that associate with positive and negative outcomes. Genocea plans to use these insights to help prospectively define, in a commercial or clinical setting, patients who could benefit from these therapies.

Genocea is also advancing a personalized neoantigen cancer vaccine program toward the filing of an Investigational New Drug (IND) application in 2017. This program leverages Genocea’s deep vaccinology experience along with ATLAS’s differentiated ability to select vaccine antigens based on an individual’s comprehensive T cell responses to the mutations in their own cancer. The company believes that ATLAS overcomes the weaknesses of conventional algorithm approaches to cancer antigen selection, which have significant false positive prediction rates.

The company also updated progress on the development of a vaccine for cancers associated with Epstein Barr Virus (EBV). ATLAS screening has already identified novel T cell antigens, including those which appear to be associated with natural immunity against EBV infection and antigen selection and prioritization is ongoing.

Collaboration with Checkmate Pharmaceuticals, Inc.

This morning, the Company announced a research collaboration with Checkmate to characterize patterns of T cell responses to tumor-associated antigens in advanced melanoma. The goal of the collaboration is to identify the specificity and characteristics of T cells associated with protective T cell responses to potentially optimize clinical development and ultimately, clinical practice with CMP-001. ATLAS will be used to profile the T cell responses of approximately 20 patients enrolled in Checkmate’s ongoing Phase 1b clinical trial of CMP-001 in combination with the checkpoint inhibitor pembrolizumab to a library of tumor-associated antigens common to patients with advanced melanoma. The T cell response signatures of those patients who respond to CMP-001 / pembrolizumab combination therapy will be compared to the signatures of those who do not respond, thereby potentially identifying antigens associated with positive or negative patient outcomes.

Collaboration with US Oncology Research

Genocea also announced this morning a new collaboration with US Oncology Research, one of the USA’s largest research programs specializing in oncology clinical trials, to screen the T cell responses of cancer patients with solid tumors who will be treated with checkpoint inhibitors against the complete repertoire of patient-specific putative cancer neoantigens. The objective of the collaboration is to use ATLAS to further Genocea’s expertise in identifying signatures of T cell responses in cancer patients and to discover new T cell cancer vaccine antigens.

R&D Day Replay

A replay of the R&D day can be accessed at: View Source

About ATLAS
ATLAS is a first of its kind proprietary rapid antigen identification screening system designed to find targets of protective T cell responses. The technology solves challenges to date associated with finding targets of T cell responses. ATLAS can examine T cell responses from large, diverse human populations, and comprehensively screen every potential antigen from a pathogen or cancer in a rapid, high-throughput manner, taking weeks versus years to find relevant antigens. Because targets identified by ATLAS are based on actual human immune responses to all potential antigens, with no guesswork or predictions, by the time these candidates reach clinical trials there may be a greater likelihood of success in clinical development. This approach provides the ability to identify smarter targets for use in developing vaccines and immunotherapies to treat infectious disease, cancer and autoimmunity.

Cellectar Biosciences Announces USPTO Grants Patent Allowances for
Radiotherapeutic PDCs for A Variety of Solid Tumor Types

On December 14, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused clinical stage biotechnology company, reported that the United States Patent and Trademark Office ("USPTO") has issued patent allowances covering method of use for radiotherapy with the company’s lead compound, CLR 131, as well as CLR 125, another of the company’s pipeline products using its proprietary phospholipid drug conjugate ("PDC") to deliver a radio therapeutic (Filing, 8-K, Cellectar Biosciences, DEC 14, 2016, View Source [SID1234517072]).

The allowance covers radiotherapy applications for a broad range of solid tumors, specifically: lung, adrenal, intestinal, colon, colorectal, ovarian, cervical, prostate, liver, breast, subcutaneous and pancreatic cancers, as well as melanoma, retinoblastoma, glioma, carcinosarcoma, squamous cell carcinoma and hepatocellular carcinoma. These claims are a continuation of US Patent No. 8,877,159, which provides patent protection into 2025.

"This patent allowance further expands the intellectual property protection of our lead radiotherapeutic candidate beyond the hematologic cancers we are currently researching," said Jim Caruso, president and CEO of Cellectar. "The expanded patent estate provides us and any potential partners with the option to advance CLR 131 clinical development into a wide variety of solid tumor applications."

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon pre-clinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

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Arrowhead Reports Fiscal 2016 Year End Results

On December 14, 2016 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2016 fourth quarter and year ended September 30, 2016 (Press release, Arrowhead Research Corporation, DEC 14, 2016, View Source [SID1234517070]). The company is hosting a conference call at 4:30 p.m. EST to discuss results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and enter Conference ID 33791749.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 404-537-3406 and enter Conference ID 33791749.

Selected Fiscal 2016 and Recent Events

Discontinued development of ARC-520, ARC-521, and ARC-AAT in November 2016
The Company announced that it would be discontinuing these clinical programs, which utilized the intravenously administered DPCivTM, or EX1, delivery vehicle, and redeploying its resources and focus toward utilizing the Company’s new proprietary subcutaneous and extra-hepatic delivery systems
The decision to discontinue development of EX1-containing programs was based primarily on two factors:
During ongoing discussions with regulatory agencies and outside experts, it became apparent that there would be substantial delays in all clinical programs that utilize EX1, while the Company further explored the cause of deaths in a non-clinical toxicology study in non-human primates exploring doses of EX1 higher than those planned to be used in humans
The Company has made substantial advances in RNA chemistry and targeting resulting in large potency gains for subcutaneous administered and extra-hepatic RNAi-based development programs
Because of the discontinuation of its existing clinical programs, the Company also reduced its workforce by approximately 30%, while maintaining resources necessary to support current and potential partner-based programs and the Company’s pipeline
Entered into two collaboration and license agreements with Amgen
Total deal value of up to $673.5 million
Arrowhead received $56.5 million upfront:
$35 million in upfront cash payments, $21.5 million equity investment
Up to low double-digit royalties for ARO-LPA and single-digit royalties for the undisclosed target, ARO- AMG1
Amgen receives:
Exclusive license to ARO-LPA program
Option for an additional candidate against an undisclosed target, ARO- AMG1
Amgen will be wholly responsible for funding and conducting all clinical development and commercialization
Continued progress on preclinical candidates including ARO-HBV, ARO-AAT, ARO-F12, ARO-LPA, and ARO-HIF2
Regarding ARO-F12 and ARO-LPA:
Presented preclinical data at the American Heart Association’s Scientific Sessions 2016 for two development programs using Arrowhead’s proprietary subcutaneous delivery platform:
RNAi triggers against Factor 12 (F12) showed dose dependent reductions in serum F12
A statistically significant reduction (p=0.002) in thrombus weight was observed at greater than 95% F12 knockdown in a rat arterio-venous shunt model
There was no increased bleeding risk in ARO- F12-treated mice, even with greater than 99% knockdown of F12 levels
RNAi triggers against Lipoprotein (a) [Lp(a)] led to greater than 98% maximum knockdown after a single 3 mg/kg SQ dose in Transgenic mice
In an atherosclerosis model, data suggest that RNAi triggers can be effectively delivered to a fatty liver using the subcutaneous delivery platform
Regarding ARO-HIF2
Presented preclinical data showing that ARO-HIF2 inhibited renal cell carcinoma growth and promoted tumor cell death in its preclinical studies
Strengthened the Company’s balance sheet with August 2016 private offering and Amgen agreement upfront payments
In August 2016, the Company sold 7.6 million shares of Common Stock to certain institutional investors and received net proceeds of approximately $43.2 million
As part of the collaboration and license agreements as well as a Common Stock Purchase Agreement with Amgen, $14 million of the total $56.5 million upfront cash payments and equity investments were received in September 2016, and the remaining $42.5 million was received in November 2016
Continued progress on former drug candidates prior to the discontinuations
Presented preclinical and clinical data on former drug candidate ARC-AAT at the Liver Meeting
In a first-in-human clinical study, ARC-AAT was well tolerated and induced deep and durable reduction of the target AAT protein
The preclinical data suggest a possible improvement of liver health and arrest of further damage from treatment with ARC-AAT
Advanced former drug candidate ARC-521 into a Phase 1/2 study
Conducted multiple dose and combination studies of former drug candidate ARC-520
Selected Fiscal 2016 Year End Financial Results

ARROWHEAD PHARMACEUTICALS, INC.
CONSOLIDATED FINANCIAL INFORMATION

Year Ended September 30
OPERATING SUMMARY
2016 2015

REVENUE $ 158,333 $ 382,000
OPERATING EXPENSES
Research and development 41,454,452 47,267,361
Acquired in-process research and development - 10,142,786
Salaries and payroll-related costs 19,461,656 16,554,008
General and administrative expenses 9,940,737 7,931,184
Stock-based compensation 11,595,816 10,232,897
Depreciation and amortization 3,260,045 2,336,207
Impairment expense 2,050,817 -
Contingent consideration – fair value adjustments (5,862,464 ) 1,891,533
TOTAL OPERATING EXPENSES 81,901,059 96,355,976
OPERATING LOSS (81,742,726 ) (95,973,976 )
OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES 19,724 4,033,094
NET LOSS $ (81,723,002 ) $ (91,940,882 )

EARNINGS PER SHARE (BASIC AND DILUTED): $ (1.34 ) $ (1.60 )
WEIGHTED AVERAGE SHARES OUTSTANDING 61,050,880 57,358,442

FINANCIAL POSITION SUMMARY
September 30,
2016 2015
CASH AND CASH EQUIVALENTS 85,366,448 81,214,354
SHORT-TERM INVESTMENTS - 17,539,902
TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS AND INVESTMENTS) 85,366,448 98,754,256
OTHER ASSETS 42,810,057 33,513,658
TOTAL ASSETS 128,176,505 132,267,914
TOTAL LIABILITIES 33,152,246 22,646,280
TOTAL STOCKHOLDERS’ EQUITY 95,024,259 109,621,634
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY 128,176,505 132,267,914

SHARES OUTSTANDING 69,746,685 59,544,677
PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED SHARES) 72,417,675 62,215,667