Portola Pharmaceuticals to Present New Interim Phase 2 Data for Cerdulatinib at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 25, 2018 Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) reported that new interim results from the Company’s ongoing Phase 2a study of cerdulatinib in patients with Non-Hodgkin Lymphoma (NHL), including B-cell NHL and relapsed/refractory peripheral T-cell lymphoma (PTCL), will be presented during a Poster Discussion Session at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 1-5, in Chicago (Press release, Portola Pharmaceuticals, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344587 [SID1234525697]).

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Cerdulatinib is an investigational oral, dual SYK/JAK kinase inhibitor that uniquely inhibits two key cell signaling pathways that promote cancer cell growth in certain hematologic malignancies. It is being developed for the treatment of resistant or relapsed hematologic cancer.

Poster Presentation Details:

Presentation Title: The Dual SYK/JAK Inhibitor Cerdulatinib Demonstrates Rapid Tumor Responses in a Phase 2 Study in Patients with Relapsed/Refractory B- and T-Cell Non-Hodgkin Lymphoma (NHL)

Presenter: Paul A. Hamlin, M.D., Memorial Sloan Kettering Cancer Center

Abstract Number: 7511

Poster Board: 148

Session Title: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 2018 from 1:15 p.m. – 2:30 p.m. CT

Location: E450, McCormick Place

NewLink Genetics Announces Presentation of Abstracts at ASCO 2018 Annual Meeting

On April 25, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) today reported that two abstracts pertaining to the company’s indoximod program will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago (Press release, NewLink Genetics, APR 25, 2018, View Source [SID1234525696]).

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Poster Discussion Session: Poster Board #204 – Abstract 4015 – Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine / nab-paclitaxel for the treatment of patients with metastatic pancreas cancer – to be presented during the discussion session, "Gastrointestinal (Noncolorectal) Cancer," Sunday, June 3, 2018, 4:45 PM – 6:00 PM CT

Poster Discussion Session: Poster Board #339 – Abstract 9512 – Phase 2 trial of the IDO pathway inhibitor indoximod plus checkpoint inhibition for the treatment of patients with advanced melanoma – to be presented during the discussion session, "Melanoma/Skin Cancers," Monday, June 4, 2018, 4:45 PM – 6:00 PM CT

The complete text of abstracts selected for presentation at the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting will be posted to the ASCO (Free ASCO Whitepaper) website on Wednesday, May 16th at 5pm ET.

"We are pleased to have the opportunity to present the results at ASCO (Free ASCO Whitepaper) from both of these Phase 2 trials of indoximod in combination therapies for patients with pancreatic cancer and advanced melanoma. We continue to gather data supporting the potential for our differentiated IDO pathway inhibitor, indoximod, in multiple combinations to improve the lives of patients with cancer," said Nicholas N. Vahanian, MD, President.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, chemotherapy, radiation and cancer vaccines across multiple indications such as melanoma, pancreatic cancer and other malignancies.

NanOlogy to Present Abstract on Preclinical Study of Nebulized NanoPac for Lung Cancer at 2018 ASCO Annual Meeting

On April 25, 2018 NanOlogy LLC, a clinical-stage pharmaceutical development company, reported that it will present an abstract detailing results of a preclinical trial of a nebulized form of NanoPac (submicron particle paclitaxel) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago, June 1 – 5 (Press release, NanOlogy, APR 25, 2018, View Source [SID1234525695]).

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The abstract, "NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model," will be presented Sunday, June 3, 8 am to 11:30 am, in Hall A of the McCormick Place.

NanOlogy is currently conducting Phase 2 clinical trials of NanoPac sterile suspension for ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer and pancreatic mucinous cysts.

In addition, NanOlogy and affiliate, DFB Soria, are progressing clinical trials of Soria-developed SOR007, a topical ointment form of NanoPac for cutaneous metastases and actinic keratosis. Clinical trials for NanoDoce, (submicron particle docetaxel) are planned in 2018 pending IND approval.

The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into patent-pending, stable, naked submicron particles with exponentially increased surface area and unique geometry. The technology enables delivery of concentrated doses of paclitaxel and docetaxel directly into the disease site without the serious adverse side effects associated with systemic infusions of the chemotherapy.

Integra LifeSciences Reports First Quarter 2018 Financial Results

On April 25, 2018 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the first quarter ending March 31, 2018 (Press release, Integra LifeSciences, APR 25, 2018, View Source [SID1234525694]).

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First Quarter 2018 Consolidated Results

Reported revenue was $357.1 million, an increase of 38.1% compared to the first quarter of 2017; acquisitions contributed $91.6 million of revenue to the first quarter, and organic revenues increased 3.0%;

GAAP earnings per share was $0.14, reflecting an increase of 75.0% compared to the first quarter of 2017;

Adjusted earnings per share was $0.58, reflecting an increase of 48.7% compared to the first quarter of 2017;

Cash flow from operations was $41.5 million, reflecting an increase of 43.8% from the first quarter of 2017;

The company is raising its full-year 2018 guidance based on strong first quarter results to

Revenue of $1.47 billion to $1.49 billion (previously $1.46 billion to $1.48 billion);

GAAP EPS of $0.69 to $0.77 (previously $0.60 to $0.70); and

Adjusted EPS of $2.34 to $2.42 (previously $2.25 to $2.35).

The company is reiterating its full-year 2018 guidance for organic sales growth to be approximately 5.0%.

Total revenues for the first quarter 2018 were $357.1 million, reflecting an increase of 38.1%, over the first quarter of 2017. Sales in the Codman Specialty Surgical segment increased 51.1% compared to the first quarter of 2017, driven by the acquired revenues from Codman Neurosurgery, as well as strong capital sales of CUSA Clarity. Sales in the Orthopedics and Tissue Technologies segment increased 18.2%, reflecting a full quarter of sales from Derma Sciences and strength in both our regenerative technologies, as well as our ankle and shoulder portfolios.
Total organic revenues increased 3.0% over the first quarter of 2017, excluding acquisitions, divestitures and the effect of currency exchange rates, slightly ahead of our expectations.
"We are off to a strong start in 2018, which gives us the confidence to increase our full-year 2018 financial guidance," said Peter Arduini, Integra’s president and chief executive officer. "We are pleased with the progress of the Codman integration and continued progress in the OTT channel expansion. We expect to see organic growth accelerate in the remainder of the year."
The company reported GAAP net income of $11.0 million, or $0.14 per diluted share, for the first quarter of 2018, compared to GAAP net income of $6.4 million, or $0.08 per diluted share, in first quarter of 2017. The increase in GAAP net income results from higher revenues, better operating expense leverage, and a lower tax rate.
The adjusted measures discussed below are computed with the adjustments to GAAP reporting that are set forth in the attached reconciliation.
Adjusted EBITDA for the first quarter of 2018 was $83.2 million, or 23.3% of revenue, compared to $55.2 million, or 21.3% of revenue, in the first quarter of 2017. The margin improvement was largely based on better operating expense leverage, mostly from general and administrative costs.
Adjusted net income for the first quarter of 2018 was $46.1 million, an increase of 49.4% from the prior year’s quarter. Adjusted earnings per share for the first quarter of 2018 were $0.58, an increase of 48.7% over the prior year’s quarter.
2018 Full-Year Outlook
The company is raising its full-year 2018 revenue guidance by $10 million to a new range of $1.47 billion to $1.49 billion, based on the strong performance of the Codman Specialty Surgical segment in the first quarter of 2018, as well as a higher benefit expected from foreign currency translation. The company is raising its full-year 2018 GAAP and adjusted earnings per share guidance range by $0.08 to a new range of $0.69 to $0.77 and $2.34 to $2.42, respectively.
The company is reiterating its full-year 2018 guidance for organic sales to be approximately 5.0%.
"In addition to the strong revenue performance in the quarter, we were pleased with the significant improvement in EBITDA margin and strong operating cash flow," said Glenn Coleman, Integra’s chief financial officer. "This puts us on track to achieve the high-end of our full-year guidance for these metrics for the remainder of this year."

In the future, the company may record, or expects to record, certain additional revenues, gains, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 AM ET today, Wednesday, April 25, 2018, to discuss financial results for the first quarter and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.
Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.
Access to the live call is available by dialing (323) 794-2093 and using the passcode 5958152. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available through April 30, 2018 by dialing (719) 457-0820 and using the passcode 5958152. The webcast will also be archived on the website.

Incyte Highlights Abstracts Accepted for Presentation at the 2018 ASCO Annual Meeting

On April 25, 2018 Incyte Corporation (Nasdaq:INCY) reported that multiple abstracts from its research and development portfolio will be presented at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois from June 1-5, 2018 (Press release, Incyte, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344710 [SID1234525693]).

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Data at ASCO (Free ASCO Whitepaper) 2018 include oral presentations from a Phase 1 study of ruxolitinib (Jakafi), lenalidomide and methylprednisolone in patients with relapsed and refractory multiple myeloma, the DeCidE1 trial assessing the combination of DPX-Survivac, cyclophosphamide and epacadostat in patients with recurrent epithelial ovarian cancer, and the Phase 3 ECHO-301/KEYNOTE-252 study evaluating the safety and efficacy of epacadostat in combination with pembrolizumab in patients with unresectable or metastatic melanoma.

"Data featured in the abstracts presented at ASCO (Free ASCO Whitepaper) will contribute to the broader scientific understanding of our targeted and immuno-oncology therapies and their potential role in the treatment of cancer," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We look forward to sharing data from our portfolio at the 2018 ASCO (Free ASCO Whitepaper) annual meeting as we continue to work toward our goal of improving the lives of patients with cancer and other serious diseases."

Select key abstracts and presentations include:

Targeted therapy abstracts

A Phase 1 Trial of Ruxolitinib, Lenalidomide, and Methylprednisolone for Relapsed/Refractory Multiple Myeloma Patients. (Abstract #8005, oral abstract session)

Friday, June 1, 2018, 2:45 – 5:45 p.m. CT, E450

Immuno-oncology abstracts

Clinical Data from the DeCidE1 trial: Assessing the First Combination of DPX-Survivac, Low Dose Cyclophosphamide (CPA), and Epacadostat (INCB024360) in Subjects with Stage IIc-IV Recurrent Epithelial Ovarian Cancer. (Abstract #5510, clinical science symposium)

Sunday, June 3, 2018, 9:45 – 11:15 a.m. CT, S406

Epacadostat (E) Plus Pembrolizumab (P) Versus Pembrolizumab Alone in Patients (pts) with Unresectable or Metastatic Melanoma: Results of the Phase 3 ECHO-301/KEYNOTE-252 Study. (Abstract #108, clinical science symposium)

Sunday, June 3, 2018, 9:45 – 11:15 a.m. CT, Hall D1

Pilot Trial of an Indoleamine 2,3-dioxygenase-1 (IDO1) Inhibitor Plus a Multipeptide Melanoma Vaccine in Patients with Advanced Melanoma. (Abstract #3033, poster session)

Monday, June 4, 2018, 8:00 – 11:30 a.m. CT, Hall A, Poster Board #247

Epacadostat Plus Nivolumab for Advanced Melanoma: Updated Phase 2 Results of the ECHO-204 Study. (Abstract #9511, poster discussion session)

Monday, June 4, 2018, 1:15 – 4:45 p.m. CT, Hall A, Poster Board #338; Discussion at 4:45 – 6:00 p.m. CT, E451

Full session details and data presentations at the ASCO (Free ASCO Whitepaper) 2018 annual meeting can be found here.