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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.

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]):

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.

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.

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.

Regeneron Announces Upcoming Investor Conference Presentation

On May 23, 2019 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast its presentation at the Goldman Sachs 40th Annual Global Healthcare Conference at 9:20 a.m. Pacific Time (12:20 p.m. Eastern Time) on Tuesday, June 11, 2019 (Press release, Regeneron, MAY 23, 2019, View Source [SID1234536562]).

The session may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A replay of the webcast will be archived on the Company’s website and will be available for 30 days.

Zymeworks Announces Corporate Update Conference Call

On May 23, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that it will host a webcast and conference call to discuss progress on its 2019 corporate priorities, including clinical development plans for its lead therapeutic candidates as well as recently announced and established corporate partnerships (Press release, Zymeworks, MAY 23, 2019, View Source [SID1234536559]).

Webcast and Conference Call Details

Zymeworks will host a webcast and conference call on Wednesday, May 29, 2019 at 8:30am ET (5:30am PT).

Interested parties can access the live webcast via a link from Zymeworks’ website at View Source or join the live call and Q&A by dialing 1-800-319-4610 for North American callers, or 1-604-638-5340 for international callers. Callers should dial in five to 10 minutes prior to the scheduled start time and ask to join the "Zymeworks call".

A recorded replay will also be available on the website shortly after the call concludes.