On August 9, 2016 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company"), a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health, reported financial and operating results for the second quarter ended June 30, 2016.

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Commenting on recent key developments, David A. Dodd, President and Chief Executive Officer of the Company, stated, "After the end of Q2, we concluded two important out-license agreements for Zoptrex, confirming the market’s interest in our lead oncology compound, Zoptrex (zoptarelin doxorubicin). Zoptrex is a novel synthetic peptide carrier linked to doxorubicin as a New Chemical Entity (NCE). Based on recent information regarding the survival of patients in the Phase 3 clinical trial of Zoptrex, we expect to complete the trial by year-end. If the results of the trial warrant doing so, we intend to file a new drug application for Zoptrex in the first half of 2017."

Mr. Dodd continued his commentary with an update on the development of Macrilen (macimorelin), "We are pleased to announce that we should complete enrollment in our confirmatory Phase 3 study of Macrilen for the evaluation of adult growth hormone deficiency by the end of August. As a result, we are very confident that the study of Macrilen will be concluded in 2016. If our expectations for completion of the confirmatory Phase 3 study are realized and if the top-line results indicate that the product attained the primary endpoint of the Phase 3 study, we expect to file an NDA for Macrilen during the first half of 2017. Since the regulatory review period for the Macrilen confirmatory study is six months, we could begin commercializing the product late in 2017."

Second Quarter 2016 Financial Highlights

R&D costs were $3.7 million for the three-month period ended June 30, 2016 and $7.4 million for the six-month period then ended, compared to $4.5 million and $8.9 million, respectively, for the three-month and six-month periods ended June 30, 2015. The decrease for the three-month and six-month periods ended June 30, 2016, as compared to the same period in 2015, is mainly attributable to lower comparative third-party costs. Third-party costs attributable to Zoptrex decreased considerably during the three-month and six-month periods ended June 30, 2016, as compared to the same periods in 2015, mainly due to the fact that dosing of patients in the ZoptEC trial was completed in February 2016. This is consistent with our expectations as we are approaching the end of the clinical trials. In addition, during 2015, we started the confirmatory Phase 3 clinical trial of Macrilen, which explains the increase in costs for this product candidate. The overall decrease in R&D costs is also explained by lower employee compensation and benefits costs, lower facilities rent and maintenance as well as lower other costs. A substantial portion of this decrease is due to the realization of cost savings in connection with our effort to streamline our R&D activities and to increase our commercial operations and flexibility by reducing our R&D staff, which was started in 2014, and for which a provision was recorded in the third quarter of 2014.

G&A expenses were $1.9 million for the three-month period ended June 30, 2016, and $3.8 million for the six-month period then ended, compared to $2.0 million and $5.4 million, respectively, for the three-month and six-month periods ended June 30, 2015. The comparative decrease for the six-month period is mainly attributable to the recording, in the prior year quarter, of certain transaction costs allocated to warrants in connection with the completion of the March 2015 Offering.

Selling expenses were $1.7 million for the three-month period ended June 30, 2016 and $3.4 million for the six-month period then ended, essentially unchanged as compared to the three-month and six-month periods ended June 30, 2015. The selling expenses for the three- and six-month periods ended June 30, 2016 and 2015 represent the costs of our contracted sales force related to the co-promotion activities as well as our internal sales management team. Those activities were launched during the fourth quarter of 2014.

Net loss for the three-month and six-month periods ended June 30, 2016 were $7.0 million and $10.7 million, respectively, or $0.71 and $1.08, respectively, both per basic and diluted share. During the same three-month and six-month periods in 2015, our net loss was $15.1 million and $24.8 million, respectively, or $13.65 and $27.22, respectively, per basic and diluted share for the same period in 2015. The decrease in net loss for the three-month and six- month periods ended June 30, 2016, as compared to the same periods in 2015, is due largely to lower operating expenses and higher comparative net finance income.

Cash and cash equivalents were approximately $26.2 million as at June 30, 2016, compared to approximately $33.0 million as at March 31, 2016.

On August 9, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN) reported financial results for its fiscal fourth-quarter 2016, provided an update on recent business highlights and provided fiscal first-quarter 2017 and fiscal year 2017 financial guidance (Press release, Myriad Genetics, AUG 9, 2016, View Source [SID:1234514554]).

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"Fourth-quarter performance met our expectations, and we continue to make substantial progress on advancing our product portfolio and growing Myriad into a larger, more diversified personalized medicine company," said Mark C. Capone, president and CEO of Myriad. "Myriad is on track to deliver on its five year strategic goals. We continue to be the worldwide leader in hereditary cancer testing, and our portfolio diversification efforts are accelerating with substantive volume growth and reimbursement for new commercial products, pivotal validations for our pipeline products, the acquisitions of Assurex Health and Sividon, and significant international expansion. Given the multibillion dollar market opportunity for our portfolio, we remain confident that we can deliver better health outcomes for patients and significant long-term value for shareholders."

Financial Highlights

Below are tables summarizing the financial results and revenue by product class for our fiscal fourth-quarter 2016 and full fiscal-year 2016:

Revenue
Fiscal Fourth-Quarter Fiscal Year
($ in millions) 2016 2015 % Change 2016 2015 % Change
Molecular diagnostic testing revenue

Hereditary cancer testing revenue $ 152.8 $ 163.8 (7 %) $ 632.3 $ 638.3 (1 %)

Vectra DA testing revenue 12.7 11.8 8 % 47.8 43.7 9 %

Prolaris testing revenue 3.5 0.7 400 % 11.3 2.1 438 %

Other testing revenue 4.8 2.5 92 % 14.3 11.4 25 %

Total molecular diagnostic testing revenue 173.8 178.8 (3 %) 705.7 695.5 2 %

Pharmaceutical and clinical service revenue 12.7 11.1 14 % 48.1 27.6 74 %

Total Revenue $ 186.5 $ 189.9 (2 %) $ 753.8 $ 723.1 4 %

Income Statement
Fiscal Fourth-Quarter Fiscal Year
($ in millions) 2016 2015 % Change 2016 2015 % Change
Total Revenue $ 186.5 $ 189.9 (2 %) $ 753.8 $ 723.1 4 %

Gross Profit 146.5 152.4 (4 %) 596.5 575.7 4 %
Gross Margin 78.6 % 80.3 % 79.1 % 79.6 %

Operating Expenses 110.8 116.2 (5 %) 429.7 441.5 (3 %)

Operating Income 35.7 36.2 (1 %) 166.8 134.2 24 %
Operating Margin 19.1 % 19.1 % 22.1 % 18.6 %

Adjusted Operating Income 39.0 48.2 (19 %) 179.5 167.3 7 %
Adjusted Operating Margin 20.9 % 25.4 % 23.8 % 23.1 %

Net Income 23.4 18.7 25 % 125.3 80.2 56 %

Diluted EPS 0.32 0.26 23 % 1.71 1.08 58 %

Adjusted EPS $ 0.36 $ 0.41 (12 %) $ 1.63 $ 1.45 12 %

Business Highlights

myRisk Hereditary Cancer
Myriad signed a new agreement with Blue Shield of California, retaining Myriad’s previous network status. Myriad ended the quarter with 65 percent of revenue under long-term contracts for its hereditary cancer business.
A new study in the New England Journal of Medicine demonstrated that in patients with advanced prostate cancer, the rate of deleterious mutations in myRisk genes was approximately 12 percent. This is consistent with other cancers that have genetic testing guidelines. Every year in the United States approximately 25,000 patients are diagnosed with advanced prostate cancer.
Myriad made the first content additions to myRisk adding three additional genes including GREMM1, POLE and POLD-1. These genes were recently added to the NCCN guidelines on genetic testing based upon their role in hereditary colon cancer.
Myriad announced the ability to customize the myRisk panel for genetics experts who are interested in ordering a subset of the myRisk genes on the full panel.

Vectra DA
Vectra DA volumes were up five percent year-over-year in the fiscal fourth-quarter with approximately 41,300 tests performed.
Myriad signed three additional private payer contracts for Vectra DA that collectively cover approximately one million lives in the United States.
At the European League Against Rheumatism (EULAR) annual meeting, Myriad presented new data showing the ability of Vectra DA to predict sustained clinical remission after discontinuation of Humira. In patients with a low Vectra DA score, 57 percent had sustained clinical remission following discontinuation of Humira. In patients with a high Vectra DA score, 60 percent experienced flare within one year of discontinuation of Humira.
In a second study presented at EULAR of 180 treatment naïve patients, the Vectra DA score was a statistically significant predictor of clinical remission with 12-month remission rates meaningfully higher in patients with a greater reduction in Vectra DA score versus those with a smaller reduction.

Prolaris
Prolaris volume increased 91 percent year-over-year and 11 percent sequentially with approximately 4,750 tests ordered.
At the American Urological Association annual meeting, Myriad presented the first study validating Prolaris exclusively in a low-risk only patient population. In 440 patients with a Gleason score of six or less, patients with a high Prolaris score had three times the rate of prostate specific mortality and eight times the rate of biochemical recurrence relative to patients with a low Prolaris score.
Myriad signed three additional private payer contracts for Prolaris that collectively cover approximately one million lives in the United States.

Companion Diagnostics
Myriad presented data from the first prospective validation of myChoice HRD in concert with TESARO’s NOVA study. In the study, which evaluated platinum-sensitive ovarian cancer patients, myChoice HRD positive patients receiving niraparib demonstrated a 9.1 month increase in progression free survival relative to patients receiving placebo.

Sividon Diagnostics Acquisition
Myriad completed the acquisition of Sividon Diagnostics during the fiscal fourth quarter and gained United States and Chinese distribution rights to EndoPredict, a best-in-class breast cancer prognostic test. Myriad announced plans to launch EndoPredict in the United States in the second half of fiscal year 2017.
A large head-to-head study comparing EndoPredict with Oncotype Dx was recently published in the Journal of the National Cancer Institute. The study, which evaluated 928 women from the TransATAC study, showed that EndoPredict "markedly outperformed" Oncotype Dx with a prognostic power that was more than four times greater. Also, EndoPredict low-risk patients had a 10-year rate of distant metastases of 5.8 percent versus low risk Oncotype Dx patients at 10.1 percent.

Assurex Health Acquisition
In August, Myriad signed a definitive agreement to acquire Assurex Health, a personalized medicine company providing treatment decision support to healthcare providers for their patients with mental health disorders. Assurex’s lead product, GeneSight Psychotropic, evaluates 12 genes known to play a significant role in psychotropic drug response and is used in patient treatment selection. Assurex performed over 150,000 GeneSight tests in Myriad’s fiscal year 2016 and generated more than $60 million in total revenue. The acquisition is subject to the satisfaction of customary closing conditions.

International
International revenues were up 93 percent year-over-year in the fourth quarter and accounted for approximately six percent of total product revenue in the quarter.
Myriad recently signed an agreement with BMI Healthcare in the United Kingdom covering Myriad’s complete testing portfolio including EndoPredict, Prolaris, Tumor BRACAnalysis CDx and hereditary cancer testing. BMI Healthcare is the largest private hospital group comprised of 59 hospitals and clinics across the UK, servicing 1,500,000 outpatient visits per year.

Share Repurchase
During the quarter, the Company repurchased approximately 1.6 million shares, or $55 million, of common stock under our share repurchase program and ended the quarter with approximately $195 million remaining on our current share repurchase authorization.
Fiscal Year 2017 and Fiscal First-Quarter 2017 Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2017 and fiscal first-quarter 2017 financial guidance:

Revenue Adjusted
Earnings Per
Share GAAP Diluted
Earnings Per
Share
Fiscal Year 2017 $740-$760 million $1.00-$1.10 $0.47 – $0.57

Fiscal First-Quarter 2017 $168-$170 million $0.25-$0.27 $0.14 – $0.16

Myriad’s fiscal year 2017 financial guidance includes the impact of the Assurex Health acquisition which Myriad expects to close at the end of the fiscal first-quarter 2017.

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during its conference call today to discuss the fiscal fourth-quarter financial results and fiscal year 2017 and fiscal first-quarter 2017 financial guidance.

On August 9, 2016 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has agreed to extend through August of 2017 and expand its sponsored research agreement with MD Anderson Cancer Center (MD Anderson), the world’s largest cancer research facility (Press release, Moleculin, AUG 9, 2016, View Source [SID1234519562]).

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Moleculin’s Chairman and CEO, Walter Klemp, commented, "The research we have sponsored to date at MD Anderson has generated some very promising new technologies, including WP1066, a novel small molecule that is an effective stimulator of patients’ natural immune response and inducer of tumor cell death in the in vivo models of even the most difficult to treat cancers." He added, "We are now extending and expanding this agreement in light of new indications that we may be able to improve upon the WP1066 technology significantly."

Dr. Waldemar Priebe, Professor of Medicinal Chemistry at MD Anderson and Scientific Advisor to Moleculin, a shareholder and inventor of licensed technology, explained, "We are very excited about the potential for orally administered WP1066 in clinic, and we are now actively investigating expansion of clinical uses of Moleculin’s licensed therapeutics and researching their methods of administration while preserving drugability of this and similar compounds. For example, the injectable/iv administered versions of WP1066 would greatly expand its clinical applications and commercial potential. The continued research sponsored by Moleculin could make this possible."

Mr. Klemp concluded, "Moleculin’s continuing research sponsorship also facilitates access to grant funding from both public and private sources, and we are pleased that the expansion of this critical research collaboration will provide access to cutting edge research capability and potentially create more patentable discoveries."

On August 9, 2018 The Board of Directors (the ‘‘Board’’) of Luye Pharma Group Ltd. (the ‘‘Company’’, together with itssubsidiaries, the ‘‘Group’’) reported that the Group’s product candidate, Goserelin Acetate Extended Release Microspheres for Injection (LY01005), has obtained the approval from the China Food and Drug Administration (the ‘‘CFDA’’) to initiate clinical trials for the treatment ofcarcinoma of the prostate (Press release, Luye Pharma, AUG 9, 2016, View Source;id=663103 [SID1234525075]). This product has also obtained the approval from the United States Food and Drug Administration (the ‘‘FDA’’) to initiate clinical trials for the treatment of carcinoma of theprostate in March this year.

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LY01005 is the Group ’s monthly extended release microspheres for intramuscular formulation ofgoserelin acetate, a gonadotropin -releasing hormone agonist, applying our microspheres injection technology. It is an oncology product candidate for the treatment of certain cancers and other indications, including prostate cancer, breast cancer and endometriosis. LY01005 is now being registered via a 505(b)(2) pathway of the United States Federal Food, Drug and Comestic Act in the United States ( ‘‘U.S.’’). The Company believes its extended-release microspheres formulation ofgoserelin acetate may have similar bioavailability as compared to another marketed product (goserelin implant), with better patient compliance and more stable efficacy.

The Company had filed a Patent Cooperation Treaty application for its goserelin microsphere pharmaceutical composition in 2014 and such PCT application entered into the U.S., Europe, Japan and certain other countries in 2015.

According to IMS Health Incorporated, the market size for gonadotropin -releasing hormone agonist products in China in 2015 was approximately RMB2.79 billion, and grew at a compound annual growth rate of 21.6% from 2013 to 2015. The Company believes that LY01005 has a good marketing potential – 1 – and will provide an impetus to the Group ’s development in the oncology therapeutic area. In addition toChina and the U.S., the Company is also targeting to obtain clinical trial approval for this potential new drug in Europe and Japan.

Apart from LY01005, the Company is currently developing several new pharmaceutical products both in China and the U.S., including Risperidone Extended Release Microspheres for Injection (LY03004 ), which had been confirmed by the FDA for New Drug Application for submission in the U.S. without additional clinical trials, Rotigotine Extended Release Microspheres for Injection (LY03003 ), which had completed phase I trials in the U.S. and Ansofaxine Hydrochloride Extended Release Tablets (LY03005 ) which had also completed phase I trials in the U.S.

On August 9, 2016 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) report financial results for its fiscal 2016 third quarter ended June 30, 2016 (Press release, Arrowhead Research Corporation, AUG 9, 2016, View Source [SID:1234514413]). The company is hosting a conference call at 4:30 p.m. EDT 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 57990579.

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 57990579.

Fiscal 2016 Third Quarter and Recent Company Highlights

Corporate Events

Today priced an at-the-market private offering of $45 million of common stock
ARC-520

Presented promising ARC-520 hepatitis B data at The International Liver Congress 2016
Expanded the MONARCH study to include additional sites, investigators, and cohorts, including patients with HBV and hepatitis Delta virus co-infection
ARC-521

Initiated a Phase 1/2 study of ARC-521 designed to evaluate the safety, tolerability, and pharmacokinetics of single doses of ARC-521 in healthy volunteers and the safety, tolerability, and antiviral activity of single and multiple doses of ARC-521 in patients with chronic HBV. Two of a planned six normal volunteer cohorts have dosed, with the third cohort expected to dose this week
ARC-AAT

Completed enrollment in Part A of a Phase 1 study in healthy volunteers
Received approval from regulatory authorities in Canada, Ireland, and Sweden to begin a Phase 2 study designed to determine the effect of multiple doses of ARC-AAT on intrahepatic alpha-1 antitrypsin levels as evidenced by changes in liver biopsy in patients with alpha-1 antitrypsin deficiency
Platform and Early Pipeline

Presented promising new preclinical data on ARC-LPA for cardiovascular diseases and ARC-HIF2 for renal cell carcinoma showing that important advancements are being made to Arrowhead’s delivery platforms to include subcutaneous administration and extra-hepatic targeting capabilities
Selected Fiscal 2016 Third Quarter Financial Results

ARROWHEAD PHARMACEUTICALS, INC.
CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited)

Three Months Ended
June 30,
Nine Months Ended
June 30,
OPERATING SUMMARY
2016 2015 2016 2015

REVENUE $ 39,583 $ 123,750 $ 127,083 $ 338,250
OPERATING EXPENSES
Research and development 9,423,195 7,490,400 29,782,854 36,877,925
Acquired in-process research and development - - - 10,142,786
Salaries and payroll-related costs 4,113,262 3,570,531 12,281,841 10,262,799
General and administrative expenses 2,275,628 1,829,393 8,045,571 5,612,219
Stock-based compensation 2,750,785 2,486,074 7,547,967 6,706,009
Depreciation and amortization 818,200 741,058 2,416,461 1,480,656
TOTAL OPERATING EXPENSES 19,381,070 16,117,456 60,074,694 71,082,394
OPERATING LOSS (19,341,487 ) (15,993,706 ) (59,947,611 ) (70,744,144 )
OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES (79,256 ) 57,653 446,595 3,546,398
NET LOSS $ (19,420,743 ) $ (15,936,053 ) $ (59,501,016 ) $ (67,197,746 )

EARNINGS PER SHARE (BASIC AND DILUTED): $ (0.32 ) $ (0.27 ) $ (1.00 ) $ (1.19 )
WEIGHTED AVERAGE SHARES OUTSTANDING 59,966,955 59,492,867 59,764,129 56,631,297

FINANCIAL POSITION SUMMARY
June 30, September 30,
2016 2015
CASH AND CASH EQUIVALENTS 43,616,543 81,214,354
SHORT-TERM INVESTMENTS 1,030,556 17,539,902
TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS AND INVESTMENTS) 44,647,099 98,754,256
OTHER ASSETS 40,886,397 33,513,658
TOTAL ASSETS 85,533,496 132,267,914
TOTAL LIABILITIES 26,108,330 22,646,280
TOTAL STOCKHOLDERS’ EQUITY 59,425,166 109,621,634
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY 85,533,496 132,267,914

SHARES OUTSTANDING 60,429,405 59,544,677
PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED SHARES) 63,100,395 62,215,667