Constellation Pharmaceuticals to Host Analyst/Investor Meeting at ASCO to Discuss Interim Update of Data of CPI-0610 in MANIFEST Clinical Trial

On May 23, 2019 ConstellationPharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that it will host an analyst/investor event and webcast on June 4 at 7:00 AM CDT (8:00 AM EDT) in the Jackson Park D room at the Hyatt Regency McCormick Place in Chicago, in conjunction with the annual meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Constellation Pharmaceuticals, MAY 23, 2019, View Source [SID1234536545]).

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The agenda of the meeting will include:

An overview of myelofibrosis (MF) and the potential impact of Constellation’s BET inhibitor CPI-0610 in treating MF
A review of the interim data from the MANIFEST clinical trial presented in a poster at ASCO (Free ASCO Whitepaper) on June 3
A panel discussion with two key opinion leaders in MF:
Dr. Srdan Verstovsek, a medical oncologist at the University of Texas MD Anderson Cancer Center and an investigator in the MANIFEST trial, and
Dr. Raajit Rampal, a hematologic oncologist at Memorial Sloan Kettering Cancer Center
The event will be webcast live and can be accessed on the Investor Relations section of Constellation’s website at View Source Participants may also access the event and participate in the live question-and-answer session by dialing (877) 473-2077 (domestic) or (661) 378-9662 (international) and referring to conference ID 1295319.

Cstone partner Agios Announces the Phase 3 ClarIDHy Trial of TIBSOVO (ivosidenib) Achieved its Primary Endpoint

On May 23, 2019 The partner of CStone Pharmaceuticals ("Cstone"; HKEX:2616), Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) ("Agios") reported that the global Phase 3 ClarIDHy trial of TIBSOVO (ivosidenib) in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 (IDH1) mutation met its primary endpoint (Press release, CStone Pharmaceauticals, MAY 23, 2019, View Source [SID1234536563]). Treatment with TIBSOVO demonstrated a statistically significant improvement in progression-free survival (PFS) by independent radiology review compared with patients who received placebo. The safety profile observed in the study was consistent with previously published data.

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A full analysis of the ClarIDHy trial will be submitted for presentation at the European Society for Medical Oncology Congress in 2019. Agios plans to submit a supplemental new drug application for TIBSOVO in previously treated IDH1 mutant cholangiocarcinoma by the end of 2019.

Cholangiocarcinoma is a very aggressive tumor for which surgical resection is the primary treatment option. Many patients are undiagnosed until the mid-to-late stages when they have missed the time window for surgery. At present, there is no standard second- and third-line treatment for patients with advanced cholangiocarcinoma. Patients typically suffer a poor prognosis and short-term survival.

China is among the countries with the highest incidence of Cholangiocarcinoma which is associated with a variety of high-risk factors including hepatitis B and Clonorchis sinensis infection, diseases that are endemic in the country.

In June 2018, CStone entered into an exclusive collaboration and license agreement with Agios to develop and commercialize TIBSOVO in Greater China region.

ClarIDHy Phase 3 Trial
The ClarIDHy trial is a global, randomized Phase 3 trial in previously treated IDH1 mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting. As of the January 31, 2019 data cutoff, 185 patients were randomized.

Patients were randomized 2:1 to receive either single-agent TIBSOVO 500 mg once daily or placebo with crossover to TIBSOVO permitted at the time of documented radiographic progression per RECIST 1.1.
The primary endpoint of the trial is PFS as evaluated by independent radiology review with secondary endpoints including investigator evaluated PFS, safety and tolerability, overall response rate, overall survival, duration of response, PK/PD and quality of life assessments.
The study was designed with 96% power to detect a hazard ratio of 0.5 for PFS (TIBSOVO vs. placebo), with a one-sided alpha of 0.025.
Thermo Fisher Scientific is providing next-generation sequencing to detect IDH1 mutations for all tumor samples as inclusion criteria for enrollment in the study and will develop and commercialize the validated companion diagnostic.
TIBSOVO is not approved in any country for the treatment of patients with advanced cholangiocarcinoma.

About TIBSOVO (ivosidenib)

TIBSOVO is indicated in the United States for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in:

Adult patients with newly-diagnosed AML who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Adult patients with relapsed or refractory AML.

Nordic Nanovector ASA – Results for the First Quarter 2019

On May 23, 2019 Nordic Nanovector ASA (OSE: NANO) reported its results for the first quarter 2019 (Press release, Nordic Nanovector, MAY 23, 2019, View Source [SID1234553450]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CEST, see details below.

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Eduardo Bravo, CEO, commented:

"As we advance the clinical development programmes with Betalutin, including PARADIGME, we are also beginning to initiate some of the other pre-commercialisation activities, such as manufacturing, that are crucial to ensure that we can submit our regulatory filing in a timely and efficient manner. The recent fundraising is key to this and we expect to intensify these activities as we get closer to the initial data read-out from PARADIGME."

Q1’19 Highlights

Approximately NOK 225 million (USD 26.4m) (gross) raised in a private placement and subsequent repair offering to support manufacturing and other activities in preparation for the commercialisation of Betalutin.
Pivotal Phase 2b PARADIGME trial of Betalutin in advanced recurrent follicular lymphoma (FL) progressing with 74 (of 80-85) sites in 23 countries open for enrolment, as of 22 May 2019.
Jan H. Egberts, M.D. elected new Chairman of the Board of Directors.
Dr Mark Wright appointed as Head of Manufacturing to lead production of Betalutin for clinical trials and future commercialisation, and of CD37-targeting candidates emerging from the company’s pipeline.

Events after Q1’19

Phase 1b Archer-1 trial of Betalutin plus rituximab (RTX) in patients with relapsed/refractory 2L FL advanced into second safety cohort.
Phase 1 LYMRIT 37-05 trial of Betalutin in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) advanced to the final dosing cohort – preliminary results from the dose-escalation expected in 2H 2019.
Promising preclinical results from R&D collaboration to develop a novel CD37-targeting alpha therapy for B-cell tumours were presented at the 11th International Symposium on Targeted-Alpha-Therapy.
Fredrik Haavind appointed Head of Legal and Compliance bringing significant experience in domestic and international corporate law.
Financial Highlights Q1’19

(Figures in brackets = same period 2018 unless otherwise stated)

Revenues for the first quarter amounted to NOK 0.0 million (NOK 0.0 million).
Total operating expenses for the first quarter were NOK 90.0 million (NOK 82.3 million).
Comprehensive loss for the first quarter amounted to NOK 91.6 million (loss of NOK 90.7 million).
Cash and cash equivalents amounted to NOK 538.5 million as at 31 March 2019 (NOK 440.1 million as 31 December 2018).
Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for recurrent FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical study. The company’s pivotal Phase 2b PARADIGME trial with a once-only administration of Betalutin in 3L R/R FL is underway with the initial clinical data read-out targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.

Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in the first half of 2020.

Nordic Nanovector intends to maximize the value of Betalutin across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments. The company is also evaluating opportunities with other CD37-targeting radioimmunotherapies and antibody drug conjugates across NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place at 8:30am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2019 from 7:00am CEST the same day.

DXC Technology Delivers Strong Fourth Quarter Results with Sequential Growth in Revenue, Bookings, and Cash Flow

On May 23, 2019 DXC Technology (NYSE: DXC) reported results for the three and twelve months ended March 31, 2019 (Press release, DynPort Vaccine Company, MAY 23, 2019, View Source [SID1234536546]).

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"DXC Technology closed out our fourth quarter, and our fiscal year, by delivering strong digital performance and sequential growth in revenue, bookings, and cash flow," said Mike Lawrie, chairman, president and CEO. "We continued to enhance our portfolio of digital offerings, and we are re-skilling current employees to equip them with new digital capabilities and certifications. We have also hired thousands of new employees with advanced digital skills, and added more through acquisitions, to further scale our digital workforce. Our acquisition of Luxoft is expected to be completed as planned by the end of June, and this will further strengthen DXC’s ability to design and deploy transformative digital solutions for clients at scale."

Financial Highlights – Fourth Quarter Fiscal 2019

Diluted earnings per share from continuing operations was $1.01 in the fourth quarter, including $(0.13) per share of restructuring costs, $(0.24) per share of transaction, separation and integration-related costs, $(0.37) per share of amortization of acquired intangible assets, and $(0.43) per share of pension and OPEB actuarial and settlement losses. This compares with $1.80 in the year ago period.
Non-GAAP diluted earnings per share from continuing operations was $2.19.
Revenue in the fourth quarter was $5,280 million compared with $5,584 million in the year ago period.
Income from continuing operations before income taxes was $354 million for the fourth quarter, including $(47) million of restructuring costs, $(96) million of transaction, separation and integration-related costs, $(138) million of amortization of acquired intangibles, and $(143) million of pension and OPEB actuarial and settlement losses. This compares with $588 million in the year ago period.
Non-GAAP income from continuing operations before income taxes was $778 million compared with $812 million in the year ago period.
Net income was $271 million for the fourth quarter, including $(35) million of restructuring costs, $(66) million of transaction, separation and integration-related costs, $(101) million of amortization of acquired intangibles, and $(116) million of pension and OPEB actuarial and settlement losses. This compares with $565 million in the prior year period.
Non-GAAP net income was $589 million.
Adjusted EBIT was $827 million in the fourth quarter compared with $882 million in the prior year. Adjusted EBIT margin was 15.7% compared with 15.8% in the year ago quarter.
Net cash provided by operating activities was $748 million in the fourth quarter, compared with $557 million in the year ago period.
Adjusted free cash flow was $917 million in the fourth quarter.
Financial Highlights – Fiscal 2019

Diluted earnings per share from continuing operations was $4.35 in fiscal 2019, including $(1.25) per share of restructuring costs, $(1.06) per share of transaction, separation and integration-related costs, $(1.42) per share of amortization of acquired intangible assets, $(0.41) per share of pension and OPEB actuarial and settlement losses, and $0.16 per share of tax adjustment related to U.S. tax reform. This compares with $5.23 in the year ago period.
Non-GAAP diluted earnings per share from continuing operations was $8.34.
Revenue in fiscal 2019 was $20,753 million compared with $21,733 million in the year ago period.
Income from continuing operations before income taxes was $1,515 million for fiscal 2019, including $(465) million of restructuring costs, $(401) million of transaction, separation and integration-related costs, $(539) million of amortization of acquired intangibles, and $(143) million of pension and OPEB actuarial and settlement losses. This compares with $1,304 million in the year ago period.
Non-GAAP income from continuing operations before income taxes was $3,063 million compared with $2,758 million in the prior year.
Net income was $1,262 million for fiscal 2019, including $(353) million of restructuring costs, $(299) million of transaction, separation and integration-related costs, $(401) million of amortization of acquired intangibles, $(116) million of pension and OPEB actuarial and settlement losses, and $44 million of tax adjustment related to U.S. tax reform. This compares with $1,782 million in the prior year period.
Non-GAAP net income was $2,387 million.
Adjusted EBIT was $3,269 million in fiscal 2019 compared with $2,989 million in the prior year. Adjusted EBIT margin was 15.8% compared with 13.8% in the prior year.
Net cash provided by operating activities was $1,783 million in fiscal 2019, compared with $2,567 million in the prior year.
Adjusted free cash flow was $2,105 million in fiscal 2019.
Global Business Services (GBS)
GBS revenue was $2,191 million in the quarter compared to $2,361 million for the prior year. GBS revenues decreased 7.2% year-over-year, reflecting headwinds in the traditional applications business, including the impact of accelerated cloud adoption. GBS profit margin in the quarter was 20.4%, up from 19.4% in the prior year, reflecting ongoing workforce optimization. New business awards for GBS were $2,857 million in the fourth quarter.

Global Infrastructure Services (GIS)
GIS revenue was $3,089 million in the quarter compared to $3,223 million for the prior year. GIS revenues decreased 4.2% year-over-year. The GIS revenue reflects the ongoing migration out of legacy infrastructure environments, offset by growth in cloud infrastructure and digital workplace. GIS profit margin in the quarter was 14.1%, down from 14.6% in the prior year, reflecting investments in digital capabilities and assets. New business awards for GIS were $2,968 million in the fourth quarter.

Returning Capital to Shareholders
During the fourth quarter, DXC Technology returned $142 million to shareholders, consisting of $51 million of common stock dividends and $91 million in share repurchases.

Earnings Conference Call and Webcast
DXC Technology senior management will host a conference call and webcast today at 5 p.m. EDT. The dial-in number for domestic callers is (888) 394-8218. Callers who reside outside of the United States should dial +1 (323) 794-2588. The passcode for all participants is 9706900. The webcast audio and any presentation slides will be available on DXC Technology’s Investor Relations website.

A replay of the conference call will be available from approximately two hours after the conclusion of the call until May 30, 2019. The replay passcode is also 9706900.

Non-GAAP Measures
In an effort to provide investors with supplemental financial information, in addition to the preliminary and unaudited financial information presented on a GAAP and pro forma basis, we have also disclosed in this press release preliminary non-GAAP information including: constant currency, earnings before interest and taxes ("EBIT"), EBIT margin, adjusted EBIT, adjusted EBIT margin, non-GAAP income before income taxes, non-GAAP net income, non-GAAP EPS and adjusted free cash flow. Reconciliations of the preliminary non-GAAP measures to the respective most directly comparable measures calculated on a GAAP or pro forma basis, as well as the rationale for management’s use of non-GAAP measures, are included below.

MorphoSys to Present at Upcoming Investor Conferences

On May 23, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that will present at the following conferences (Press release, MorphoSys, MAY 23, 2019, View Source [SID1234536565]):

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Jefferies Healthcare Conference
Date: June 5, 2019, 8:00am EDT (2:00pm CEST, 1:00pm BST)
Venue: New York, NY, U.S.
Presenter: Jens Holstein, Chief Financial Officer of MorphoSys AG
Dr. Julia Neugebauer, Director Corporate Communications & IR

dbAccess Berlin
Date: June 6, 2019
Venue: Berlin, Germany
Presenter: Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG
Dr. Verena Kupas, Manager Corporate Communications & IR

Goldman Sachs 40th Annual Global Healthcare Conference
Date: June 12, 2019
Venue: Los Angeles, CA, U.S.
Presenter: Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG
Dr. Sarah Fakih, Head of Corporate Communications & IR

J.P. Morgan European Healthcare Conference
Date: June 20, 2019
Venue: London, UK
Presenter: Dr. Sarah Fakih, Head of Corporate Communications & IR
Dr. Julia Neugebauer, Director Corporate Communications & IR

Meet the Team – Analyst and Investor Event
Date: June 25, 2019, 10:00am EDT (4:00pm CEST, 3:00pm BST)
Venue: New York, NY, U.S.
Participants: Management Team of MorphoSys AG and MorphoSys US Inc.

PDF versions of the presentations will be provided at www.morphosys.com. Links to available webcasts will be filed under www.morphosys.com/conference-calls.