On May 3, 2016 Kancera AB reported their interim results for Q1 2016, January 1 – March 31, 2016 (Press release, Kancera, MAY 3, 2016, View Source;releaseID=1143395 [SID:1234511821]).

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The period January to March 2016 in brief

R&D expenses for the period amounted to SEK 4.2m (SEK 4.2m).
Operating income for the period amounted to SEK -5.1m (SEK 4.9m).
Income after financial items for the period amounted to SEK -5.0m (SEK -4.9m).
Earnings per share for the period were SEK -0.05 (SEK -0.05).
Cash flow from operating activities for the period amounted to SEK -6.3m (SEK -5.1m).
Equity as of March 31, 2016 amounted to SEK 17.0m (SEK 22.6m) or SEK 0.16 (SEK 0.22) per share. The equity/assets ratio as of March 31, 2016 was 70 percent (71 percent).
Cash and cash equivalents as of March 31, 2016 amounted to SEK 12.1m (SEK 17.8m).
Significant events during the period

Kancera has from the 1st of January 2016 extended the lease of the company’s laboratories within the Karolinska Science Park for three years through an agreement with Humlegården Fastigheter.
Kancera has provided an update of the small molecule patent portfolio.
– A patent covering small molecule PFKFB3 inhibitors has been approved in the USA.

– A patent application covering new chemical series in the HDAC6 project has been filed.

– An international patent application covering ROR inhibitors has been strengthened by adding examples of additional highly potent ROR inhibitors.

Kancera reported that the company has developed a new series of ROR inhibitors that show improved pharmaceutical properties which will allow preclinical studies of their effect on e.g. solid tumors. These results have prompted Kancera to concentrate the investments in the ROR project to small molecule inhibitors and terminate the product development of a ROR-based vaccine. Furthermore, Kancera reported results from the Fractalkine project showing that KAN0440567 after oral administration to mice effectively blocks the function of the Fractalkine receptor.
Kancera announced that the company according to plan has received another payment of about SEK 2.8 million in January, 2016 from the EU for the A-PARADDISE project, which aims to develop drugs against parasitic diseases.
Significant events after the end of the reporting period

Kancera announced that the Extraordinary General Meeting of Kancera AB approved the Board’s decision of 6 April 2016 to issue new shares and warrants in the form of units. The decision includes a preferential rights issue of shares and warrants (units) ("New Share Issue"), which upon full subscription brings Kancera about SEK 52 million before issue expenses and with a full exercise of the warrants brings Kancera an additional SEK 52-62 million. The issue assets will be used for Kancera’s drug development, clinical studies and the further development of the Company’s capacity to commercialize products. The majority of Kancera’s resources are now concentrated on taking at least one of Kancera’s drug candidates in the ROR and Fractalkine projects to clinical trial for chronic lymphocytic leukemia and pancreatic cancer, respectively. In parallel, the Company intends to validate a broader use of the drug candidates from these projects in order to demonstrate their full commercial potential.
Kancera reported that ROR inhibitors have been tested against human triple negative breast cancer transferred to zebra fish. The experiments showed that Kancera’s small molecule ROR inhibitors are able to both reduce tumor size and metastases (spread) of this aggressive tumor form. Further, Kancera reported that the company´s PFKFB3 inhibitors are active in the same model of triple negative breast cancer and that a patent application has been filed covering the discovery that PFKFB3 inhibitors enhance the effect of radiation treatment
Kancera reported that the Company due to positive efficacy data in disease models of cancer and pain has decided to exercise the exclusive option to acquire the Fractalkine project. The acquisition will be carried out in connection with the completion of the ongoing transfer of results and know-how from Acturum and AstraZeneca to Kancera. Payment for the project to Acturum Life Science AB will be made into three steps by a total of 6 million shares, of which the first payment is due at the submission of the application for authorization of a clinical trial after an approval by Kancera´s shareholders. In parallel, the company intends to validate a broader use of the drug candidate (KAN0440567) in order to demonstrate its full commercial potential.
Statement from the CEO

In 2016, we have reported progress in the development of a new generation of ROR inhibitors with properties that we expect will enable effect against both lymphoma and solid tumors. A first study where human triple negative breast cancer was transplanted into zebra fish, shows that ROR inhibitors are able to both inhibit tumor growth and prevent spread. Further, we have been able to validate that Kancera PFKFB3 inhibitor is able to inhibit tumor growth in the same model.

On the patent side, we have completed an international patent application in the ROR project with the addition of approximately 100 selected potent compounds. Also, a patent application covering PFKFB3 substances has been approved in the United States and a new application covering the discovery that Kancera’s PFKFB3 inhibitor counteract cancer by enhancing the effect of radiation treatment has been submitted. An additional patent application has been filed in the HDAC6 project covering a new class of active substances which together with the first patent application in the project, broadens the protection around our unique selective and effective compounds against myeloma.

Furthermore, due to positive efficacy data in disease models of cancer and pain, the Kancera Board has decided to exercise the exclusive option to acquire the Fractalkine project.

The goal for the next 18-24 months is to take at least one of Kancera’s drug candidates from the Fractalkine and ROR projects to clinical trials and thus first clinical use (chronic lymphocytic leukemia/ pancreas cancer). In parallel, we also complete the evaluation of a broader use of the drug candidates from these projects in order to reduce the risk in the product development and to identify full commercial potential of the projects. The operational objectives also include delivering drug candidates from the HDAC6 and PFKFB3 projects.

Given these ambitious goals, Kancera’s Board supported by the decision of the Extraordinary General Meeting on April 22, 2016, decided to launch a new share issue. The decision includes a preferential rights issue of shares and warrants (units) which upon full subscription brings Kancera about SEK 52 million before issue costs.

With eight patent families, which together make up the intellectual property protection for four small-molecule cancer projects, we expect that Kancera has good opportunities to translate scientific results into commercially attractive new drugs against cancer. However, the development of new drugs is biologically and technically risky and challenged by international competition.

This share issue aims to push Kancera’s cancer project from a promising development phase to completion in order to be tested in cancer patients. I am convinced that we will succeed in this work.

On May 4, 2016 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its revenues and cash position for the first three months of 2016 (Press release, Innate Pharma, MAY 3, 2016, View Source [SID:1234511888]).

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Cash, cash equivalents and financial instruments of the Company amounted to €255.8 million as of March 31, 2016, including short term investments (€51.2m) and non-current financial instruments (€37.5m). At the same date, financial liabilities amounted to €3.6 million.

Revenues for the first three months of 2016 amounted to €5.7 million (€0.4 million for the same period in 2015). This revenue results from Innate Pharma’s collaboration and licensing agreement with Bristol-Myers Squibb and co-development and commercialization agreement with AstraZeneca:

€5.5 million resulting from the agreement with AstraZeneca, corresponding to the recognition over the period of the initial payment received in June 2015;
€0.2 million relating to the agreement with Bristol-Myers Squibb resulting from the recognition over the period of the upfront payment received in July 2011.
In 2015, revenue for the first three months resulted mainly from the recognition of the upfront payment from the agreement with Bristol-Myers Squibb.

Hervé Brailly, Chief Executive Officer and co-founder of Innate Pharma, commented: "During the first quarter of 2016, our pipeline of innovative immuno-oncology candidates continued to progress and expand. At the AACR (Free AACR Whitepaper) 2016 Annual Meeting, we presented data supporting the development of our clinical and preclinical programs, including two new programs targeting the tumor microenvironment. We are proud of these programs which further demonstrate our unique positioning in immuno-oncology.

At the same time, our most advanced programs moved forward in their clinical development. A Phase I clinical trial was started by AstraZeneca that is testing our first-in-class NKG2A checkpoint inhibitor, monalizumab, in combination with durvalumab (AstraZeneca/ MedImmune’s PD-L1 inhibitor). This fifth trial completes the roll-out of the initial clinical plan, due to start reading out in 2017. With regards to lirilumab, our first-in-class anti-KIR checkpoint inhibitor, the DSMB completed its sixth assessment of the Phase II EffiKIR study in March and recommended continuation of the trial without modification. Data on the primary endpoint are expected in the second half of 2016."

On May 3, 2016 Cerus Corporation (NASDAQ:CERS) reported financial results for the first quarter ended March 31, 2016 (Press release, Cerus, MAY 3, 2016, View Source [SID:1234511827]).

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Recent company highlights include:
Entered into long-term INTERCEPT platelet and plasma supply agreement with the American Red Cross, the largest U.S. supplier of blood components.

Entered into framework agreement with Blood Centers of America (BCA) as its pathogen reduction technology supply partner. Fifteen BCA members are now under contract for use of the INTERCEPT Blood System.

Received U.S. Food and Drug Administration (FDA) approval for use of the INTERCEPT Blood System for platelets suspended in 100% plasma, expanding the potential market for INTERCEPT in the U.S.

Pathogen reduction obviates the need for both primary and secondary bacterial screening under FDA’s revised draft guidance for controlling the risk of bacterial contamination of platelets.

Signed INTERCEPT supply agreement with Banco de Sangre de Servicios Mutuos to help sustain local platelet and plasma collections during the Zika epidemic.

FDA Zika guidance document recognizes pathogen reduction as a method to reduce transfusion risk and maintain local platelet and plasma collections in areas of active Zika transmission.

"Concerns about both the Zika virus and bacterial contamination are stimulating U.S. interest in INTERCEPT from both industry and regulators," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "We now have a significant portion of the U.S. market under contract for INTERCEPT and will be working diligently to support these customers as they begin their validation processes. Once customers have completed their validations over the next few quarters, we expect the revenue contribution from the U.S. to begin in earnest."

Revenue
Revenue for the first quarter of 2016 was $7.6 million and relatively flat compared to the prior year. Because revenue for the three months ended March 31, 2016 and 2015, was predominantly driven by Euro denominated markets, reported revenue was negatively affected by an approximate 2% weakening of the Euro compared to the U.S. dollar, the Company’s reporting currency. The Company continues to expect 2016 global revenue in the range of $37 million to $40 million.

Gross Margins
Gross margins for the first quarter of 2016 were 44%, compared to 39% for the first quarter of 2015. Margins for the first quarter of 2016 were positively impacted by the decline in the value of the Euro relative to the Company’s reporting currency, the U.S. dollar, lifting gross margins when comparing the first quarter of 2016 to the comparable period in 2015. In addition, product mix helped improve reported gross margins with higher margin platelet kits contributing proportionately more than in the prior year.

Operating Expenses
Total operating expenses for the first quarter of 2016 were $18.7 million, compared to $17.3 million for the first quarter of 2015. Selling, general and administrative expenses were relatively flat, driven by increased 2016 U.S. commercialization costs which were offset by lower accounting and other administrative fees. Research and development expenses increased as a result of activities to support our platelet label claim extension efforts, required post marketing platelet studies in the U.S. and preparation of the anticipated 2016 CE Mark submission for the red blood cell system.

Operating and Net Loss
Operating losses during the first quarter of 2016 were $15.3 million, compared to $14.4 million for the first quarter of 2015.
Net loss for the first quarter of 2016 was $16.9 million, or $0.17 per diluted share, compared to a net loss of $9.5 million, or $0.17 per diluted share, for the first quarter of 2015.

Net losses for the first quarter of 2016 were favorably impacted by approximately $1.0 million of lower foreign exchange losses during the first quarter of 2016, when compared to the corresponding prior period. Net losses in the prior year period were positively impacted by the mark-to-market adjustments of the Company’s previously outstanding warrants to fair value, which resulted in non-cash gains of $6.3 million during the first quarter of 2015. The Company has no remaining outstanding warrants and as such, does not expect mark-to-market adjustments going forward.

Cash, Cash Equivalents and Investments
At March 31, 2016, the Company had cash, cash equivalents and short-term investments of $96.4 million compared to $107.9 million at December 31, 2015. The Company’s short-term investments include a marketable equity security which was valued at $5.1 million at March 31, 2016 and $11.2 million at December 31, 2015.

At March 31, 2016, the Company had approximately $20 million in outstanding debt under its loan agreement with Oxford Finance.

On May 3, 2016 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended March 31, 2016 and provided an overview of key milestones for the company’s lead drug candidates (Filing, Q1, Lexicon Pharmaceuticals, 2016, MAY 3, 2016, View Source [SID:1234511829]).

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"We closed out the quarter with the filing of the NDA for telotristat etiprate, an important milestone for the company," said Lexicon President and Chief Executive Officer, Lonnel Coats. "We look forward to working closely with the FDA during the review process of this investigational treatment for the care of patients living with carcinoid syndrome."

Pipeline Progress

Telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase (TPH), the rate-limiting enzyme involved in serotonin production. Excess production of serotonin within metastatic neuroendocrine tumor cells can lead to carcinoid syndrome, a condition characterized by serious consequences including frequent and debilitating diarrhea, facial flushing, abdominal pain, and heart valve damage.

On March 30, 2016, Lexicon announced that it had submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of telotristat etiprate, an oral drug for the treatment of carcinoid syndrome. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Lexicon has requested a Priority Review by the FDA as part of the NDA filing.

Sotagliflozin, which is being developed as a potential treatment for type 1 and type 2 diabetes, is a dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT1 and SGLT2), each of which modulates glucose levels, and is the first investigational medicine to target both of these two proteins.

Lexicon recently entered into a collaboration with Sanofi, in which Lexicon will continue to be responsible for clinical development activities relating to type 1 diabetes and Sanofi will be responsible for clinical development activities relating to type 2 diabetes. Lexicon is conducting three Phase 3 clinical trials of sotagliflozin in patients with type 1 diabetes, one of which has already completed enrollment and the second of which has completed patient screening, and expects top-line results from its two pivotal Phase 3 clinical trials to be available in the second half of 2016. Lexicon expects that Phase 3 development of sotagliflozin in patients with type 2 diabetes will be initiated by Sanofi by the end of 2016.

Financial Highlights

Revenues: Lexicon’s revenues for the three months ended March 31, 2016 increased to $12.5 million from $1.8 million for the corresponding period in 2015, primarily due to revenues recognized from the collaboration and license agreement with Sanofi.

Research and Development Expenses: Research and development expenses for the three months ended March 31, 2016 increased 77 percent to $37.0 million from $20.9 million for the corresponding period in 2015, primarily due to increases in external clinical and nonclinical research and development costs.

Change in Fair Value of Symphony Icon Purchase Liability: In connection with the acquisition of Symphony Icon, Lexicon made an initial estimate of the fair value of the liability for the associated base and contingent payments. Changes in this liability, based on the development of the programs and the time until such payments are expected to be made, are recorded in Lexicon’s consolidated statements of operations. For the three months ended March 31, 2016 and 2015, the fair value of the Symphony Icon purchase liability increased by $1.0 million and $1.8 million, respectively.

General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2016 increased 47 percent to $8.4 million from $5.7 million for the corresponding period in 2015, primarily due to increased costs in preparation for commercialization of telotristat etiprate.

Consolidated Net Loss: Net loss for the three months ended March 31, 2016 was $34.9 million, or $0.34 per share, compared to a net loss of $28.1 million, or $0.27 per share, in the corresponding period in 2015. For the three months ended March 31, 2016 and 2015, net loss included non-cash, stock-based compensation expense of $1.8 million and $2.0 million, respectively.

Cash and Investments: As of March 31, 2016, Lexicon had $477.1 million in cash and investments, as compared to $521.4 million as of December 31, 2015.

Reverse Stock Split: In May 2015, Lexicon completed a one-for-seven reverse stock split. All references to common shares and per-share data for all periods presented in this release have been adjusted to give effect to this reverse stock split.

On May 03, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN) reported financial results for its fiscal third-quarter 2016, provided an update on recent business highlights, provided fiscal-fourth quarter financial guidance and updated its fiscal year 2016 financial guidance (Press release, Myriad Genetics, MAY 3, 2016, View Source [SID:1234511830]).

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"For the fourth consecutive quarter we have exceeded our financial projections and the highlight of this quarter was strong growth from new products including Prolaris and Vectra DA," said Mark C. Capone, president and chief executive officer of Myriad. "Importantly, we made significant progress in securing new product reimbursement coverage this quarter, and coupled with positive developments in our other development programs, we remain confident in our ability to deliver on our five-year strategic goals."

Financial Highlights

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

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

Hereditary cancer testing revenue $ 156.3 $ 159.0 (2 %)

Vectra DA testing revenue 12.3 10.5 17 %

Prolaris testing revenue 5.2 0.5 940 %

Other testing revenue 3.6 3.0 20 %

Total molecular diagnostic testing revenue 177.4 173.0 3 %

Pharmaceutical and clinical service revenue 13.1 7.0 87 %

Total Revenue $ 190.5 $ 180.0 6 %


Income Statement
Fiscal Third-Quarter
($ in millions) 2016 2015 % Change
Total Revenue $ 190.5 $ 180.0 6 %

Gross Profit 150.3 143.7 5 %
Gross Margin 78.9 % 79.8 %

Operating Expenses 107.7 108.0 0 %

Operating Income 42.6 35.7 19 %
Operating Margin 22.4 % 19.8 %

Adjusted Operating Income 45.8 46.3 (1 %)
Adjusted Operating Margin 24.0 % 25.7 %

Net Income 32.6 21.4 52 %

Diluted EPS 0.44 0.29 52 %

Adjusted EPS $ 0.41 $ 0.40 3 %

Business Highlights

myRisk Hereditary Cancer
NCCN updated its professional guidelines for hereditary cancer to include additional surgical risk-reduction considerations for multiple genes on the myRisk Hereditary cancer panel including PALB2, BRIP1, RAD51C and RAD51D. Additionally, NCCN expanded criteria for hereditary pancreatic and prostate cancer increasing the number of patients in the United States eligible for testing in these indications to approximately 25,000.
At the Society for Gynecological Oncology (SGO) meeting in March, Myriad presented data in 381 endometrial cancer patients showing that myRisk Hereditary Cancer identified 60 percent more deleterious mutations than traditional single syndrome screening.
At the American College of Medical Genetics and Genomics annual meeting, Myriad presented data demonstrating that one of its proprietary myVision algorithmic variant classification tools, Pheno, could be utilized on a broader set of cancer risk genes with greater than 99.5 percent accuracy in classification of variants of unknown significance.

Vectra DA
Vectra DA volumes were up 18 percent year-over-year and 11 percent sequentially in the fiscal third-quarter with approximately 42,500 tests performed.
Expanded the successful practice integration pilot program to the national phase with our entire rheumatology sales team in the fiscal-third quarter.
Signed two private insurance contracts totaling 2 million additional covered lives for Vectra DA.

Prolaris/Urology
Prolaris sample volume was up 90 percent year-over-year and 21 percent sequentially with approximately 4,300 tests ordered.
Signed multiple additional private insurance contracts bringing our total covered private lives to 28 million.

myPath Melanoma
The second validation study on myPath Melanoma demonstrating a 90 percent diagnostic accuracy in differentiating melanoma from benign nevi has been submitted to a major dermatology journal and we anticipate acceptance in the fiscal fourth-quarter.
Additionally, the clinical utility study on myPath Melanoma has been submitted for publication and we also anticipate acceptance of this study in the fiscal fourth-quarter.

Companion Diagnostics
Presented data at the recent SGO meeting demonstrating that myChoice HRD predicted both progression free survival and overall survival in platinum treated ovarian cancer patients. The test also performed substantially better than any of the individual proprietary markers (LOH, TAI, LST) in isolation.
Announced a research collaboration with TESARO and Merck to evaluate myChoice HRD and Myriad’s other tumor tests to predict responders to an investigational combination therapy including Merck’s anti-PD-1 therapy KEYTRUDA and TESARO’s PARP inhibitor niraparib.
Announced a research collaboration with AbbVie in non-small cell lung cancer to utilize myChoice HRD and Myriad’s other new tumor companion diagnostics to help identify potential responders to veliparib.

International
International revenues were up 40 percent year-over-year in the third quarter and accounted for approximately five percent of total product revenue in the quarter.
The French government has established provisional funding for EndoPredict and other breast prognostic tests beginning in April. France represents a market opportunity of approximately 25,000 tests per year for EndoPredict.
Signed an agreement with Hospital Corporation of America in the United Kingdom covering testing for hereditary cancer, Tumor BRACAnalysis CDx, EndoPredict and Prolaris. HCA manages six hospitals seeing approximately 500,000 patients per year in the UK.

Share Repurchase
During the quarter, the Company repurchased approximately 1.2 million shares, or $45 million, of common stock under our share repurchase program and ended the quarter with approximately $47 million remaining on our current share repurchase authorization.

Fiscal Fourth-Quarter and Fiscal Full-Year 2016 Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2016 and fiscal fourth-quarter 2016 financial guidance:

Revenue Adjusted Earnings Per Share GAAP Diluted Earnings Per Share
Fiscal Fourth-Quarter 2016 $186-$188 million $0.36-$0.38 $0.32-$0.34

Fiscal Year 2016 $753-$755 million $1.63-$1.65 $1.48-$1.50

The Company is providing fourth-quarter revenue guidance of $186 to $188 million and adjusted earnings per share of $0.36 to $0.38. As a result, the Company is narrowing the range for its fiscal full year revenue guidance to total revenue of $753 to $755 million and updating its adjusted earnings per share guidance to $1.63 to $1.65.

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 third-quarter financial results and fiscal fourth-quarter and fiscal year 2016 financial guidance.