On May 20, 2016 TG Therapeutics, Inc. (Nasdaq:TGTX), reported that updated data has been selected for presentation at the upcoming 21st European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, to be held from June 9 – 12, 2016 in Copenhagen, Denmark (Filing, 8-K, TNI BioTech, MAY 20, 2016, View Source [SID:1234512626]).

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Presentations Include:

Title: Long-term follow-up of the next generation PI3K-delta inhibitor TGR-1202 demonstrates safety and high response rates in CLL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: P207
Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
Location: Poster Hall H
Presenter: Anthony Mato, MD, University of Pennsylvania, Philadelphia, PA

Title: Long-term follow-up of the next generation PI3Kδ inhibitor TGR-1202 demonstrates safety and high response rates in NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: P315
Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
Location: Poster Hall H
Presenter: Owen A. O’Connor, MD, PhD, Columbia University Medical Center, NY, NY

Title: Preliminary results of a Phase I/Ib study of ibrutinib in combination with TGR-1202 in patients with relapsed/refractory CLL or MCL
Abstract Number: E1053
E-poster Presentation
Presenter: Matthew S. Davids MD, Dana-Farber Cancer Institute, Boston, MA

A copy of the EHA (Free EHA Whitepaper) abstracts were made available yesterday, May 19, 2016 through the EHA (Free EHA Whitepaper) meeting website at www.ehaweb.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

On May 19, 2016 Horizon Pharma plc (NASDAQ: HZNP) ("Horizon Pharma"), a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, reported that its affiliate has entered into a definitive agreement with Boehringer Ingelheim International GmbH ("Boehringer Ingelheim") to acquire the rights to interferon gamma-1b, which Boehringer Ingelheim commercializes under the trade names IMUKIN, IMUKINE, IMMUKIN and IMMUKINE in an estimated 30 countries primarily in Europe and the Middle East (Press release, Horizon Pharma, MAY 19, 2016, View Source [SID:1234514863]).

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"Obtaining worldwide rights for interferon gamma-1b solidifies our continued investment in the medicine, and pending the outcome of clinical studies investigating it in Friedreich’s ataxia and advanced solid tumors, such as kidney and bladder cancer, strengthens our ability to expand its potential global use," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc.

Under the terms of the agreement, Horizon Pharma paid Boehringer Ingelheim EUR 5 million upon signing and will pay EUR 20 million upon closing for the rights for interferon gamma-1b in all territories outside of the United States, Canada and Japan. Horizon Pharma and Boehringer Ingelheim expect to close the transaction by year-end 2016, subject to the satisfaction of closing conditions.

Under the terms of a separate agreement with an undisclosed third party, Horizon Pharma also licensed the U.S., European and Canadian intellectual property rights for interferon gamma-1b for the treatment of Friedreich’s ataxia. Interferon gamma-1b is currently not indicated or approved for the treatment of Friedreich’s ataxia.

On May 5, 2016, the Company announced that it completed target enrollment of 90 patients in the Phase 3, randomized, double-blind, placebo controlled STEADFAST study evaluating ACTIMMUNE in patients with Friedreich’s ataxia. Top-line results from the trial are expected by the end of 2016.

As a result of the agreement with Boehringer Ingelheim, Horizon Pharma will immediately begin investing in related manufacturing, supply chain, regulatory and commercial activities for interferon gamma-1b. As a result, the Company anticipates a reduction to 2016 adjusted EBITDA of approximately $10 million versus prior guidance.

On May 19, 2016 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming poster discussion presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from June 3-7, 2016 in Chicago, IL (Filing, 8-K, Bio-Path Holdings, MAY 19, 2016, View Source [SID:1234512709]). Dr. Maro Ohanian, Assistant Professor at the University of Texas MD Anderson Cancer Center will present data from the Company’s completed Phase I clinical trial and from the safety segment of the Phase II trial of BP1001 in combination with low-dose cytarabine (LDAC), including initial efficacy results. Notably, there were no dose-limiting toxicities observed in the safety segment and three of the six evaluable acute myeloid leukemia (AML) patients achieved complete remission, suggesting possible AML disease inhibition.

Details for the poster presentation are as follows:

Date: Monday, June 6, 2016
Presentation Time: 8:00 am – 12:45 pm Central Time
Location: Hall A, McCormick Place
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7010
Title: "Phase I Study of BP1001 (Liposomal Grb2 Antisense) in Patients with Hematologic Malignancies" (Link to abstract)
. Dr. Maro Ohanian, Assistant Professor at the University of Texas MD Anderson Cancer Center will present data from the Company’s completed Phase I clinical trial and from the safety segment of the Phase II trial of BP1001 in combination with low-dose cytarabine (LDAC), including initial efficacy results. Notably, there were no dose-limiting toxicities observed in the safety segment and three of the six evaluable acute myeloid leukemia (AML) patients achieved complete remission, suggesting possible AML disease inhibition.

Details for the poster presentation are as follows:

Date: Monday, June 6, 2016
Presentation Time: 8:00 am – 12:45 pm Central Time
Location: Hall A, McCormick Place
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7010
Title: "Phase I Study of BP1001 (Liposomal Grb2 Antisense) in Patients with Hematologic Malignancies" (Link to abstract)

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On May 19, 2016 Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based and other molecular diagnostics, reported financial results for the three months ended March 31, 2016 (Filing, Q1, Rosetta Genomics, 2016, MAY 19, 2016, View Source [SID:1234512620]).

Recent developments include:

· Expanded molecular diagnostics test menu with the launch of three new product offerings in common hematologic cancers and solid tumors;
· Received conditional approval status from the New York State Department of Health (NYSDOH) for RosettaGX Reveal, the Company’s novel microRNA classifier for the diagnosis of indeterminate thyroid Fine Needle Aspirate (FNA) smears;
· Entered into an agreement that establishes health insurance access to Rosetta’s entire suite of diagnostic tests and services with America’s Choice Provider Network (ACPN), an independent multispecialty national provider network; and
· Granted U.S. patent allowance for use of gene expression signature for classification of kidney tumors and granted European patent allowance for use of microRNA molecules for the treatment of liver cancer.

Management Commentary

"We are especially pleased to report record quarterly clinical testing revenues as it demonstrates the progress we have made in expanding our molecular diagnostics test menu, selling our clinical testing products and improving collections," said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "Throughout the first quarter we completed the revamping of our sales force and invested in our billing and collections department. The results are reflected in our growing revenue and expanding customer base, as well as in improved collections. Further, these changes position us to drive revenue growth throughout the balance of the year and beyond.

"The commercial launch of RosettaGX Reveal continues to be a prime focus for our team. We expect the positive performance data from our blinded validation study to be published in a peer-reviewed journal in the coming weeks. These data demonstrate exceptional performance and we anticipate that a journal publication will strongly support our reimbursement and sales efforts. In addition, our revamped sales team has been able to use RosettaGX Reveal to access new accounts to promote not only our exceptional thyroid offering, but also to promote our urologic cancer and solid tumor product lines. Since the beginning of the year, these promotional efforts resulted in the acquisition of over 30 thyroid customer accounts and over 60 new customer accounts for our urology and solid tumor businesses.

"Our work for the balance of the year will continue to focus on driving revenue growth in both our base business as well as with our new products, such as RosettaGX Reveal, expanding reimbursement, improving collections and advancing our clinical development programs, which should position us to achieve a number of important milestones that will enhance shareholder value," concluded Mr. Berlin.

First Quarter Financial Results

Please note that the pro forma comparisons below are meant to provide a comparison as if the PersonalizeDx acquisition occurred on January 1, 2015. The actual acquisition date was April 13, 2015.

· Revenues for the first quarter of 2016 increased 711% to $2.6 million compared with revenues of $321,000 for the first quarter of 2015, and increased 27% compared with pro forma revenues of $2.1 million for the first quarter of 2015.
· Revenues from urologic cancer testing services in the first quarter of 2016 were $1.4 million, an increase of 7% compared with pro forma revenues of $1.3 million for the first quarter of 2015, and represented approximately 54% of clinical testing revenues for the quarter.
· Revenues from solid tumor testing services in the first quarter of 2016 increased 272% to $1.2 million compared with revenues of $321,000 for the first quarter of 2015, and increased 58% compared with pro forma revenues of $0.8 million in the first quarter of 2015. Solid tumor testing services represented nearly 46% of total clinical testing revenues during the first quarter of 2016, with the balance coming from RosettaGX Reveal.
· Cost of revenues for the first quarter of 2016 increased to $1.7 million compared with $352,000 for the first quarter of 2015, due to the acquisition of PersonalizeDx leading to a higher volume of processed samples, as well as to increases in personnel and infrastructure.
· Research and development expenses for the first quarter of 2016 increased to $842,000 from $748,000 for the first quarter of 2015, primarily due to increased activities in Thyroid and other areas.
· Sales, marketing and business development expenses for the first quarter of 2016 increased to $1.9 million from $1.6 million in the prior-year period due to a larger commercial footprint as a result of the acquisition of PersonalizeDx.
· General and administrative expenses for the first quarter of 2016 increased to $2.2 million compared with $1.4 million for the same period in 2015, with the increase primarily due to increased personnel and activities related to the acquisition of PersonalizeDx.
· The operating loss for the first quarter of 2016 was $4.0 million, which included $230,000 of non-cash stock-based compensation expense, compared with an operating loss of $3.8 million for the first quarter of 2015, which included $276,000 of non-cash stock-based compensation expense.

· The net loss for the first quarter of 2016 was $4.0 million, or $0.20 per ordinary share on 20.7 million weighted average shares outstanding, compared with a net loss for the first quarter of 2015 of $3.9 million, or $0.30 per ordinary share on 12.8 million weighted average shares outstanding.
· On a non-GAAP basis, excluding $230,000 of non-cash stock-based compensation expense, the net loss for the first quarter of 2016 was $3.8 million, or $0.18 per ordinary share on 20.7 million weighted average shares outstanding. For the first quarter of 2015, excluding the $276,000 of non-cash stock-based compensation expense, the non-GAAP net loss was $3.6 million, or $0.28 per ordinary share on 12.8 million weighted average share outstanding.

Balance Sheet Highlights

As of March 31, 2016, Rosetta Genomics had cash, cash equivalents, restricted cash and short-term bank deposits of $12.6 million compared with $13.6 million as of December 31, 2015. The Company used approximately $2.6 million in cash to fund operations during the first quarter of 2016, and collected approximately $2.7 million in cash from its clinical testing services in addition to $1.6 million in cash receipts from a licensing deal signed in December 2015. Based on the Company’s current operations and plans, which include a cost-reduction plan should it be unable to raise sufficient additional capital, if necessary, Rosetta Genomics expects its current cash position will fund operations for at least the next 12 months.

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On May 19, 2016 Celator Pharmaceuticals, Inc. (Nasdaq:CPXX) reported that Phase 3 clinical trial data for VYXEOS (cytarabine:daunorubicin) Liposome for Injection (also known as CPX-351), its lead product candidate, will be presented at upcoming medical conferences (Press release, Celator Pharmaceuticals, MAY 19, 2016, View Source [SID:1234512619]).

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Presentation at ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, June 3-7, 2016:

Date & Track Time:
Saturday, June 4, 2016 – 3:00pm to 6:00pm CT

Track:
Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant

Presentation Title:

Final results of a phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML

Presenter:
Jeffrey E. Lancet, M.D., H. Lee Moffitt Cancer Center & Research Institute

Abstract #:
7000

Presentation Time:
3:00pm to 3:12pm CT

Location:
Arie Crown Theatre

Presentation at EHA (Free EHA Whitepaper) Annual Congress in Copenhagen, June 9-12, 2016:

Date:
Saturday, June 11, 2016

Topic:
Acute Myeloid Leukemia – Clinical Session

Title:
New Compounds in AML Treatment

Presentation Title:
CPX-351 treatment of previously untreated older AML patients with high-risk AML markedly increases the response rate over 7+3 in patients with FLT3 mutations

Presenter:
Bruno C. Medeiros, M.D., Stanford University

Abstract Code:
S502

Presentation Time:
4:15pm to 4:30pm CET

Location:
Hall A3

The ASCO (Free ASCO Whitepaper) abstracts became available at 5:00pm ET on May 18th (abstracts.asco.org) and the EHA (Free EHA Whitepaper) abstracts at 12:00pm CET on May 19th (EHA Learning Center – Official eLearning Portal of the European Hematology Association (EHA) (Free EHA Whitepaper)).

Analyst and Investor Meeting on VYXEOS

Celator will host an Analyst and Investor meeting on Saturday, June 4, 2016 at the Chicago Marriott Downtown Magnificent Mile starting at 7:00pm CT. The meeting will discuss data from the Phase 3 clinical trial in high-risk AML patients. Seating is limited, please contact the Trout Group, Brooks Rahmer ([email protected]), regarding attendance. The meeting will be webcast and available on Celator’s website (www.celatorpharma.com).

About VYXEOS

VYXEOS (cytarabine:daunorubicin) Liposome for Injection, also known as CPX-351, is a nano-scale co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ration. VYXEOS represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic anti-tumor activity are encapsulated in a nano-scale liposome in order to maintain the desired ratio following administration. The FDA granted Breakthrough Therapy designation to VYXEOS for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC. VYXEOS was granted orphan drug status for the treatment of AML by the FDA and the European Commission. VYXEOS was also granted Fast Track designation for the treatment of elderly patients with secondary AML by the FDA.

In a Phase 3 trial in patients with high-risk (secondary) AML, the median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving the standard of care regimen of cytarabine and daunorubicin known as 7+3, representing a 3.61-month improvement in favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3. The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.

Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor of patients treated with VYXEOS. No substantial difference in Grade 3 or higher adverse events was observed between VYXEOS and 7+3. In the intent-to-treat population, Grade 3-5, hematologic adverse events were similar for overall infections, febrile neutropenia, and bleeding events. In the intent-to-treat population, Grade 3-5, non-hematologic adverse events were similar across all organ systems, including cardiac, gastrointestinal, general systems, metabolic disorders, musculoskeletal, nervous system, respiratory, skin and renal.

Celator published results from two randomized, controlled, Phase 2 trials with VYXEOS. The first trial was conducted in newly diagnosed elderly AML patients and the second trial was conducted in patients with AML in first relapse