On May 8, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported its results for the first quarter 2019 (Press release, BerGenBio, MAY 8, 2019, View Source [SID1234535900]).

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A presentation and live webcast by the Company’s management will take place today at 10.00 am CET in Oslo, please see below for details.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are pleased to see the positive strategic and clinical momentum generated in the last year continue into 2019. We have continued to see promising initial data emerging from the clinical development programme with bemcentinib, particularly in AML and NSCLC. We believe that this data provides us with sufficient evidence to begin the initiation of late stage clinical development in these indications during 2019. We are looking forward to providing an update on these data at the forthcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June."

Operational Highlights – First Quarter 2019
Lead candidate bemcentinib meets efficacy endpoint in combination with cytarabine in AML patients unfit for intensive therapy

Phase II trial evaluating bemcentinib in combination with low-intensity chemo-therapy in AML patients unfit for intensive therapy fully recruited
Bemcentinib in combination with Low-dose Cytarabine (LDAC) meets efficacy endpoint: Three out of 10 evaluable LDAC patients (30%) had CR/CRi
Combos warrant further expansion, meanwhile, company prepares for late stage bemcentinib monotherapy trial in later line elderly AML patients unfit for intensive chemotherapy
Phase II trial with bemcentinib and KEYTRUDA in NSCLC made important progress

Additional cohort (Cohort B) added under collaboration agreement with Merck & Co extending eligibility to patients who have disease progression on prior immune checkpoint inhibitors
Start of Phase II Investigator-Initiated Trial Evaluating Selective AXL Inhibitor bemcentinib in high-risk MDS

Up to 43 patients to be enrolled at leading MDS centres across Europe
Start of Phase I trial evaluating first-in-class anti-AXL antibody BGB149

BGB149, a wholly owned asset, is the first therapeutic anti-AXL monoclonal antibody to enter clinical development
Phase I study will investigate safety and pharmacokinetics in healthy volunteers
Start of phase I trial evaluating ADCT-601, a novel anti-AXL antibody drug conjugate (ADC), in patients with advanced solid tumours

ADCT-601 uses a proprietary AXL antibody developed by BerGenBio and licensed to ADC Therapeutics for ADC development
Phase I dose escalation and expansion trial will evaluate ADCT-601 in 75 cancer patients
Trial managed and sponsored by ADC Therapeutics
First clinical milestone met and milestone payment received
Preclinical data presented at AACR (Free AACR Whitepaper) reinforces bemcentinib’s potential to reverse tumour immunosuppression and therapy resistance

Extensive data in pre-clinical models of non-small cell lung cancer (NSCLC) and pancreatic cancer demonstrating AXL’s role in reversing tumour-mediated immunosuppression and therapy resistance presented at AACR (Free AACR Whitepaper)
bemcentinib shown to reverse AXL’s effects, thus acting synergistically with immune cells and anti-cancer therapies
Key appointments to executive team and Board to prepare organisation for next phase of development

Key appointments to executive team and Board to prepare organisation for next phase of development; Board of Directors strengthened. Grunde Eriksen, Debra Barker and Pamela Trail elected as new board members.
Dr Dominic Smethurst appointed as permanent Chief Medical Officer (CMO)
Favourable outcome of arbitration brought by BerGenBio against Rigel Pharmaceuticals clarifying the extent of Rigel’s entitlement to receive compensation in the event of a sale of BerGenBio, its assets, or a license to Bemcentinib
R&D grant of up to NOK 11 m awarded by Research Council of Norway
Financial highlights

Total operating expenses for the first quarter were NOK 54.5 million (Q1 2018 NOK 54.8 million)
Research and development expenses accounted for 70% of total operating expenses in Q1
Comprehensive loss for the first quarter amounted to NOK 44.3 million (Q1 2018 a loss of NOK 53.8 million)
Cash and cash equivalents amounted to NOK 306.7 million at the end of March 2019
Presentation and Webcast Details
A presentation by BerGenBio’s senior management team will take place today at 10:00 am CET at:

Felix Konferansesenter,
Bryggetorget 3,
0125 Oslo.

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.

On May 8, 2019 Arvinas, Inc. (Nasdaq: ARVN), a biopharmaceutical company creating a new class of therapies that degrades disease-causing proteins, reported financial results for the first quarter of 2019 and provided a corporate update (Press release, Arvinas, MAY 8, 2019, View Source [SID1234535898]).

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"The first quarter of 2019 was Arvinas’ first quarter as a clinical-stage company and we remain laser-focused on moving our clinical and preclinical programs ahead," said John Houston, Ph.D., Chief Executive Officer at Arvinas. "We are excited that our Phase 1 clinical trial of ARV-110 for the treatment of men with metastatic castration-resistant prostate cancer is underway and look forward to sharing preliminary clinical data regarding the trial in the second half of 2019."

Ian Taylor, Ph.D., Chief Scientific Officer at Arvinas, added, "The ARV-110 clinical trial is a milestone for patients affected by diseases that may be addressable by targeted protein degradation. Our second PROTAC protein degrader, ARV-471, remains on-track to enter the clinic in the third quarter as a potential treatment for patients with locally-advanced or metastatic breast cancer. Our recent progress has excited us further about what we can achieve with our PROTAC protein degrader platform and its potential to significantly improve the lives of patients."

Business Highlights and Recent Developments

Began dosing patients in our first clinical trial, a Phase 1 clinical trial of ARV-110, which will evaluate the safety and tolerability of ARV-110 in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on standard of care therapies. We anticipate preliminary data from the study in the second half of 2019 and believe ARV-110 is the first in a new class of targeted protein degraders to enter human clinical trials.
Completed our initial public offering (IPO) in October 2018, issuing an aggregate of 7,700,482 shares of common stock, including 200,482 additional shares of common stock upon the exercise, in part by the underwriters, of their option to purchase additional shares at a public offering price of $16.00 per share. The company received aggregate gross proceeds of approximately $123.2 million.
Anticipated Milestones and Expectations

Present preliminary safety, tolerability and pharmacokinetic data from the Phase 1 clinical trial of ARV-110 in the second half of 2019.
Initiate a Phase 1 clinical trial of ARV-471 in patients with locally advanced or metastatic ER-positive / HER2-negative breast cancer in the third quarter of 2019 and share preliminary clinical data in 2020.
Discuss our neuroscience strategy and present preclinical data from our tau program in the second half of 2019.
Financial Guidance

Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities as of March 31, 2019 will be sufficient to fund its operating expenses and capital expenditure requirements into the first half of 2021.

First Quarter Financial Highlights

Cash, Cash Equivalents, and Marketable Securities Position: As of March 31, 2019, cash, cash equivalents, and marketable securities were $175.0 million as compared to $187.8 million as of December 31, 2018. The decrease related to cash used to fund operations of $15.5 million offset by cash received from a collaborator of $2.7 million.

Research and Development Expenses: Research and development expenses were $14.2 million for the quarter ended March 31, 2019, as compared to $7.1 million for the quarter ended March 31, 2018. The increase in research and development expenses for the quarter primarily related to expenses associated with the initiation of our Phase 1 clinical trial of ARV-110 and IND-enabling expenses associated with ARV-471 as well as increased personnel and other expenses related to our platform research and exploratory programs research.

General and Administrative Expenses: General and administrative expenses were $5.6 million for the quarter ended March 31, 2019, as compared to $1.2 million for the quarter ended March 31, 2018. The increase in general and administrative expenses for the quarter was primarily related to increased employee expenses and other compliance costs associated with becoming a public company in the fourth quarter of 2018.

Revenues: Revenue was $4.0 million for the quarter ended March 31, 2019, as compared to $4.1 million for the quarter ended March 31, 2018. Revenues are generated primarily from the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Pfizer that was initiated in January 2018 and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017.

Net Loss: Net loss was $14.4 million for the quarter ended March 31, 2019, as compared to $4.2 million for the quarter ended March 31, 2018. The increase in net loss for the quarter ended March 31, 2019 was primarily due to increased research and development expenses and increased general and administrative expenses.

About ARV-110
ARV-110 is an orally-bioavailable PROTAC protein degrader designed to selectively target and degrade androgen receptor protein (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC). ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies. Arvinas believes the differentiated pharmacology of ARV-110, including its iterative activity, has the potential to translate into improved clinical outcomes for patients.

About ARV-471
ARV-471 is an orally-bioavailable PROTAC protein degrader designed to target the estrogen receptor (ER) for the treatment of patients with locally-advanced or metastatic ER-positive / HER2-negative breast cancer. A Phase 1 clinical trial for ARV-471 in patients with locally-advanced or metastatic ER-positive / HER2-negative breast cancer is expected to begin in the third quarter of 2019 and preliminary clinical data is expected in 2020.

On May 8, 2019 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported that it has completed its anticipated capital raising of $10,000,005.50 (Press release, Clarity Pharmaceuticals, MAY 8, 2019, View Source [SID1234535879]). This includes the previously announced strategic investment of $5,000,002.75 from GenesisCare, the largest private provider of cancer treatment in Australia and Europe, an additional $3,965,957.00 from the undertaking of a Rights Issue to Clarity’s existing shareholders, and now the remaining amount of $1,034,045.75 from new shareholders.

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The funds will enable Clarity to progress the development of its pipeline of radiopharmaceuticals, including Cu-64 SARTATE and Cu-67 SARTATE, which are next generation, highly targeted, theranostic (diagnostic and therapy) pharmaceuticals with increased specificity and in vivo stability. Clarity’s first theranostic trial of SARTATE in a serious brain cancer called meningioma commenced in July 2018 with the study halfway complete. Clarity will also progress clinical trials with SARTATE in neuroendocrine tumours (NETs) and neuroblastoma in collaboration with leading institutions in the US and Australia. In addition to the development of SARTATE, the capital raising will also enable the clinical development of two other products in Clarity’s pipeline, a prostate specific membrane antigen (PSMA) targeting product for the diagnosis and treatment of prostate cancer; and a bombesin product that targets the gastrin-releasing peptide receptor, which is present in a number of serious cancers including lung, ovarian, prostate, and breast.

Dr Alan Taylor, Executive Chairman of Clarity Pharmaceuticals, commented, "We are very pleased to have completed our capital raising which included a strategic investment from our partner GenesisCare, strong support from our current shareholder base as well as great demand from new investors. This capital raising also coincides with recent additions and changes to the team, including ex-Algeta CEO and CMO, Dr Thomas Ramdahl and Dr Gillies O’Bryan-Tear respectively, joining our Board, as well as former Algeta executive, Dr Colin Biggin, moving to acting CEO. Our growing team is dedicated to continuing our important work of developing safer and more effective treatments for children and adults with cancer together with a number of our collaborators and world leading experts in the field."

On May 8, 2019 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported that it has completed patient enrollment in the phase Ib/II trial of ONCOS-102 in combination with chemotherapy in unresectable malignant pleural mesothelioma (MPM) (Press release, Targovax, MAY 8, 2019, View Source [SID1234535856]).

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The trial consists of a phase Ib safety lead-in part followed by a randomized, open label phase II part, assessing the combination of ONCOS-102 and standard of care (SoC) chemotherapy (pemetrexed and cisplatin) vs SoC chemotherapy alone in first or second/third line patients with unresectable MPM. In May 2018, Targovax reported no safety issues, strong innate and adaptive immune activation and 50% disease control rate (DCR) for the six patients in the phase Ib safety lead-in cohort – see link to press release here.

The enrollment of 25 patients into the randomized phase II part of the trial has now been completed, with a total of 31 patients on the trial who will be evaluated for safety, immune response and efficacy. There are 20 patients in the experimental arm combining ONCOS-102 with chemotherapy and eleven patients in the chemotherapy only control group. The patients in the part I safety cohort form part of the experimental arm.

The aim of the trial is to assess safety and tolerability, immunological activation and 6-month overall response rate (ORR) of the combination of ONCOS-102 and SoC chemotherapy compared to SoC chemotherapy alone. Data read out is expected around New Year.

Magnus Jäderberg, CMO of Targovax, said: "We are very pleased to have completed enrollment of our mesothelioma trial. ONCOS-102 is currently the most clinically advanced oncolytic virus in this difficult to treat cancer, and therefore a high priority for us. The randomized ORR and immune data from this study will indicate whether the ONCOS-102 and chemotherapy combination gives patients a benefit over chemotherapy. The clinical and immune data will guide the further development of ONCOS-102 in mesothelioma."

On May 8, 2019 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it will report its financial results for the first quarter of 2019 on Tuesday, 14 May 2019 (Press release, Evotec, MAY 8, 2019, View Source;announcements/press-releases/p/evotec-se-to-report-first-quarter-2019-results-on-14-may-2019-5803 [SID1234535825]).

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The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. Furthermore, the Management Board will present an outlook for fiscal year 2019. The conference call will be held in English.

Conference call details

Date: Tuesday, 14 May 2019

Time: 02.00 pm CEST (08.00 am EDT, 01.00 pm BST)

From Germany: +49 69 201 744 220

From France: +33 170 709 502

From Italy: +39 02 3600 6663

From the UK: +44 20 3009 2470

From the USA: +1 877 423 0830

Access Code: 35899832#

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialling +49 69 20 17 44 222 (Germany) or +44 20 3364 5150 (UK) and in the USA by dialling +1 844 307 9362. The access code is 315534322#. The on-demand version of the webcast will be available on our website: View Source