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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On April 25, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) announced today that nine industry sponsored daratumumab abstracts, one industry sponsored ofatumumab abstract and one tisotumab vedotin abstract have been accepted for presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 1-5 (Press release, Genmab, APR 25, 2018, View Source [SID1234525692]). The daratumumab abstracts, submitted by Janssen Research & Development, LLC, include an oral presentation of a subgroup analysis of the MMY1001 (EQUULEUS) trial, two poster discussion sessions regarding the PAVO (MMY1004) and ANDROMEDA (AMY3001) studies, as well as trial in progress poster presentations on multiple other Phase III trials. These include SMM3001 (AQUILA) in smoldering multiple myeloma and MMY3012 (COLUMBA), the study comparing subcutaneous with intravenous daratumumab administration. In addition there are two posters on MMY3007 (ALCYONE) in patients with newly diagnosed multiple myeloma. One abstract on ofatumumab maintenance treatment in relapsed chronic lymphocytic leukemia (CLL), sponsored by Novartis, will be presented in a poster discussion session. One abstract regarding the Phase II study of tisotumab vedotin in cervical cancer was also accepted for a trial in progress poster presentation. The titles of the abstracts are currently available on the ASCO (Free ASCO Whitepaper) iPlanner website, with the full abstracts scheduled to be published on May 16, 2018.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased with the selection of these abstracts for presentation at this year’s ASCO (Free ASCO Whitepaper) meeting in Chicago. Attendees of this prestigious conference will be able to view for themselves both some of the very exciting data generated by these products, as well as additional information on a variety of currently running key clinical trials," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

List of Industry Sponsored Abstracts:

Daratumumab:

Daratumumab in Combination with Carfilzomib and Dexamethasone in Lenalidomide-refractory Patients with Relapsed Multiple Myeloma: Subgroup Analysis of MMY1001 – Oral presentation, Friday, June 1, 3:09 PM – 3:21 PM CDT

Subcutaneous Daratumumab Plus Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis: Safety Run-in Results of ANDROMEDA (AMY3001) – Poster discussion session, Monday, June 4, 8:00 AM – 11:30 AM CDT

Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Update of the Open-label, Multicenter, Dose Escalation Phase 1b Study (PAVO) (MMY1004) – Poster discussion session, Monday, June 4, 8:00 AM – 11:30 AM CDT

Randomized, Open-Label, Phase 3 Study of Subcutaneous Daratumumab Versus Active Monitoring in Patients with High-risk Smoldering Multiple Myeloma: AQUILA (SMM3001) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA (MMY3012) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Pomalidomide and Dexamethasone with or without Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: a Multicenter, Randomized, Phase 3 Study (APOLLO) (MMY3013) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Randomized, Open-label, Phase 2/3 Study of Daratumumab with or without JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Relapsed/Refractory Multiple Myeloma (MMY2036) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Daratumumab Plus Bortezomib-Melphalan-Prednisone (VMP) in Elderly (≥75 y) Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplantation (ALCYONE) (MMY3007) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Improved Health-related Quality of Life for Patients with Newly Diagnosed Multiple Myeloma who are Ineligible for Stem Cell Transplantation: Results from the ALCYONE Trial (MMY3007) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Tisotumab vedotin
A single arm, Phase 2, multicenter, international trial of tisotumab vedotin (HuMax-TF ADC) in previously treated, recurrent or metastatic cervical cancer – Poster presentation, Monday, June 4, 1:15 PM – 4:45 PM CDT

Ofatumumab

Role of ofatumumab maintenance treatment in relapsed CLL: Final analysis of PROLONG study – Poster discussion session, Monday, June 4, 8:00 AM – 11:30 AM

On April 25, 2018 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that it will present two posters during the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 1-5, 2018, in Chicago (Press release, Five Prime Therapeutics, APR 25, 2018, View Source [SID1234525691]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Abstract Number and Title: #TPS4135, "FIGHT: A Phase 3 Randomized, Double-Blind, Placebo Controlled Study Evaluating (Bemarituzumab) FPA144 and Modified FOLFOX6 (mFOLFOX6) in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer with a Dose Finding Phase 1 Lead-In"
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Session Date and Time:Sunday, June 3, 2018; 8:00 – 11:30 a.m. CT
Location: Hall A,PosterBoard Number: #322a

Abstract Number and Title: #3020, "Pharmacodynamics (PD) and Genomic Profiling of Pts Treated with cabiralizumab (cabira) + nivolumab (NIVO) Provide Evidence of On-Target Tumor Immune Modulations and Support Future Clinical Applications"
Poster Session: Developmental Therapeutics – Immunotherapy
Session Date and Time:Monday, June 4, 2018; 8:00 – 11:30 a.m. CT
Location: Hall A, Poster Board Number: #234
Discussion Session Date and Time:Monday, June 4, 2018; 11:30 a.m. – 12:45 p.m. CT
Discussion Session Location: Hall B1

About Bemarituzumab (FPA144)

Bemarituzumab is an isoform-selective, humanized monoclonal antibody in clinical development as a targeted immuno-therapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. Clinical results to date suggest that the specificity of FPA144 avoids toxicities that have been seen with less selective FGFR2 small molecule therapeutics. FPA144 has also been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells.

About Cabiralizumab (FPA008)

Cabiralizumab is an investigational antibody that inhibits the CSF-1 receptor and has been shown in preclinical models to block the activation and survival of monocytes and macrophages. Inhibition of CSF1R in preclinical models of several cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs) in the tumor microenvironment, thereby facilitating an immune response against tumors. Cabiralizumab is currently in clinical trials in oncology indications and in pigmented villonodular synovitis (PVNS). Cabiralizumab is being developed under an exclusive worldwide license and collaboration agreement entered into with Bristol-Myers Squibb (BMS) in October 2015.