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Nordic Nanovector ASA: Results for the First Quarter 2020

On May 26, 2020 Nordic Nanovector ASA (OSE: NANO) reported its results for the first quarter 2020. A presentation by Nordic Nanovector’s senior management team will take place today via a webcast at 08:30 am CET (Press release, Nordic Nanovector, MAY 26, 2020, View Source [SID1234558513]). A link to the webcast and a presentation is available from the company’s homepage (www.nordicnanovector.com).

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Lars Nieba, interim CEO of Nordic Nanovector, said: "Despite a number of significant challenges, the new senior management team together with the Board and all our employees have moved decisively to conduct a thorough strategic review and to implement an action plan based on its conclusions. With a clear focus on PARADIGME and a cash runway into 2021, I believe we are well placed to demonstrate and deliver the value of Betalutin to patients and to our shareholders."

Q1’20 Highlights

Dr Lars Nieba appointed as interim Chief Executive Officer
Dr Dominic Smethurst appointed as interim Chief Medical Officer
Pivotal Phase 2b PARADIGME trial of Betalutin in 3rd-line follicular lymphoma (3L FL) progressing
COVID-19 has had a negative impact on PARADIGME during H1’2020
51 patients enrolled as of May 25th, 2020
Initiated strategic review with focus on advancing PARADIGME and extending cash runway into 2021
Events after Q1’20

Strategic review completed: clinical development strategy revised, and cost-saving initiatives implemented
FDA meeting sought to discuss PARADIGME protocol amendments designed to enlarge eligible patient population and increase rate of enrolment
Enrolment timelines for PARADIGME to be updated once FDA feedback is received and when there is more clarity on the impact created by COVID-19
Planned restructuring completed
Malene Brondberg appointed as Chief Financial Officer
Corporate and personnel reorganisation implemented
Headcount reduced by approx. 20%
Cost savings of approx. NOK 35 million in connection with the restructuring on an annual basis
Betalutin recommended for Orphan Drug Designation in the European Union for Marginal Zone Lymphoma (MZL)
Financial Highlights

(Figures in brackets = same period 2019 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 125.9 million (NOK 90.0 million)
Comprehensive loss for the first quarter amounted to NOK 91.7 million (loss of NOK 91.6 million)
Cash and cash equivalents amounted to NOK 384.3 million at the end of March 2020, compared to NOK 470.8 million at the end of December 2019
Outlook

The company continues to target the readout of top line data from PARADIGME in 2021. However, due to uncertainties created by the current COVID-19 situation, there is a need to review the timeline for the enrolment of PARADIGME, which previously was guided for H2’2020. Updated timelines for PARADIGME are expected to be provided once there is more clarity on the impact of COVID-19 and when all the relevant regulatory feedback has been received.

Nordic Nanovector is fully committed to ensuring that PARADIGME has the best chance of success and the proposed protocol amendments are an important part of this. Following FDA feedback, the company intends to seek approval for these amendments at an individual country level and begin their implementation as they are approved.

The company believes that the improvements it has made to the conduct of PARADIGME puts it in a strong position to improve the rate of patient enrolment once COVID-19 restrictions are eased.

The steps the company has taken to conserve cash, including reducing headcount and pausing certain clinical trials, will extend the cash runway into 2021. The company expects to see the impact of these cost-saving initiatives emerge over the remainder of this year.

Following the comprehensive strategic review carried out by the new management team, the company believes it is now in a much-improved position to deliver the pivotal results from PARADIGME in a timely manner. This is a key milestone for Nordic Nanovector as the company seeks to bring this exciting new targeted NHL treatment to patients and maximise the value of Betalutin.

Selvita Reports Financial Results for Q1 2020: Dynamic Increase in Backlog for 2020 and Strong Position on the Market

On May 26, 2020 Selvita (WSE: SLV), one of the largest preclinical contract research organizations in Europe, reported its first quarter 2020 financial results and provided a corporate update (Press release, Selvita, MAY 26, 2020, View Source [SID1234558512]).

The company continues its dynamic growth and reports backlog for 2020 of EUR 21,8 million, indicating a 41% increase to the values reported a year ago. The increase in the value of signed contracts in the Services segment amounted to 48%.

For the first three months of 2020, Selvita reports consolidated revenues of EUR 7 million, up by 41% on a year-on-year basis, thus confirming very good preliminary estimates published on April 29, 2020. What is quite remarkable, despite the worldwide COVID-19 pandemic, the company has managed to strengthen its position in the global CRO market, especially among US customers considered the largest biotechnology market in the world.

Commercial revenues in the Services Segment amounted to EUR 5.8 million in 1Q 2020, indicating a 46% increase as compared to same period previous year. The Bioinformatics Segment’s (Ardigen, where Selvita holds 54,7 percent of votes at the General Meeting of Shareholders) commercial revenues increased by 33% and amounted to EUR 0.7 million.

Company’s EBITDA profit reached EUR 1.7 million and was by 52% higher than in Q1 2019, with a profitability margin of nearly 24%. The net result increased by 92% reaching EUR 0.8 million. These results, demonstrate that Selvita has not only maintained but in fact exceed its planned rate of growth.

– We’re sticking to the plan and not slowing down our pace of development. We’re maintaining high revenue dynamics, at the same time increasing EBITDA margin, which in Q1 2020 has increased by nearly 2 p.p. The results we managed to achieve in the past quarter are particularly satisfying, due to the global economic uncertainty caused by COVID-19 pandemic. So far, it looks like Selvita successfully went through this difficult time. We implemented safety measures in order to secure the health and safety of our employees and managed to maintain business continuity in all projects. In this uncertain environment, we were able to strengthen our position among foreign customers, especially on the U.S. market. Many pharmaceutical and biotechnology companies have realized the need for geographical diversification of outsourced services. Selvita skillfully fits into these changing trends on the preclinical CRO market – comments Bogusław Sieczkowski, co-founder, and Chief Executive Officer at Selvita.

External revenues from the services commissioned by US customers increased in Q1 2020 by 175% and already constitute over 25% of the entire Services Segment revenues. At the same time, revenues from the services commissioned by customers from the United Kingdom increased by 74%. Services contracts from these two largest global biotech & pharma markets include both drug discovery and regulatory research. Increasing customer recognition for the high quality of services and competences offered by Selvita team results in further contracts. As on May 21, the backlog in the Service Segment amounted to EUR 18.0 million, i.e. was 48% higher than same time previous year. Out of which, nearly EUR 14.0 million concerns the services in the area of drug discovery and EUR 3.5 million in regulatory research.

– The continuously growing backlog, demonstrates that during the pandemic, despite the restrictions placed on international travel and cancelation of industry events, we are able to acquire new contracts efficiently. With most of global business activity going virtual, the geographical barriers have disappeared and we can build our position on the international market on an equal level with other providers – emphasizes Bogusław Sieczkowski.

In addition to increasing revenues, Selvita’s new strategy also assumes maintaining a stable EBITDA margin and over EUR 230 million of market cap in 2023. For this purpose, in 2020-2023, the company intends to execute investments worth up to EUR 75-90 million, which will be allocated to acquisitions and organic development.

In order to execute the strategy, Selvita plans to raise approx. EUR 21 million by issuing up to 15% of the share capital in a Follow-On offering. Approximately 80% of the proceeds will be allocated for acquisitions. One of the elements of the strategy execution will be the creation of Selvita Research Center in order to secure own research space necessary for further growth. The Company has already made a first step towards execution of this aim, and signed a preliminary contract for a plot of land in the neighborhood of its current laboratories. The initiation of the investment is planned for 2021.

Medivir Appoints Yilmaz Mahshid as New CEO

On May 26, 2020 Medivir AB (Nasdaq Stockholm: MVIR) reported that its Board of Directors has appointed Yilmaz Mahshid as the new CEO of the company (Press release, Medivir, MAY 26, 2020, View Source [SID1234558511]). Yilmaz Mahshid has long and broad experience from qualified roles in the life science sector. He succeeds Uli Hacksell, who has been CEO since October 2018. Yilmaz Mahshid will assume his position in the fall. Uli Hacksell remains as a board member of Medivir.

Yilmaz Mahshid joins Medivir from his recent position as CFO at PledPharma. He was prior to that Investment Manager at Industrifonden. He has also worked as a health care analyst at Pareto Securities and at Öhman Fondkommission. Yilmaz holds a doctorate from the Department of Medical Biochemistry and Biophysics at Karolinska Institute. He began his career as a researcher at the Karolinska Institute followed by the pharmaceutical companies Biolipox and Orexo.

– Uli Hacksell assumed leadership responsibility for Medivir as acting CEO in the fall of 2018 in conjunction with the strengthened focus on clinical cancer projects and a comprehensive restructuring of the company. Uli has invested enormous energy in shaping and developing Medivir into the company it is today. When we looked for Uli’s successor, important parameters were experience, a strong scientific foundation, knowledge and insight about the industry as well as the investor perspective. In Yilmaz Mahshid we have found what we were looking for and it is my great pleasure to welcome him to Medivir", says Helena Levander, Chairman of Medivir’s Board of Directors.

– Going forward, Uli will still be strongly involved in the company’s development in his role as board member. We are extremely grateful that he led the strategically important transformation of Medivir", continues Helena Levander.

– I believe that Yilmaz will be perfect as new CEO of Medivir. He is extremely qualified and has the background, drive and strategic thinking that our exciting company needs. I will stay on as CEO until Yilmaz takes over. Shortly after the handover I will return to function solely as a board member, but I will of course be available as a sparring partner whenever Yilmaz so wishes.", says Uli Hacksell, CEO at Medivir.

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on May 26, 2020.

Acquisition of Debiopharm’s Investment Portfolio Company Kaiku Health Broadens Patient Access to Digital Oncology Intervention

On May 26, 2020 Debiopharm (www.debiopharm.com), a Swiss biopharmaceutical company, reported the successful exit and acquisition of their investment portfolio company Kaiku Health, a Helsinki-based digital therapeutics company specializing in improving the quality of life of cancer patients (Press release, Debiopharm, MAY 26, 2020, View Source [SID1234558510]). The acquisition made by the publicly traded, Stockholm-based company Elekta, one of the global market leaders in precision radiation medicine, enables a reach to over 4,000 oncology centers managing thousands of cancer patients worldwide with Elekta’s software suite, extending the company’s digital health offering.

In 2018, Debiopharm became the Series A lead investor in Kaiku Health in order to support the active adoption of their technology by hospitals, clinics, and pharmaceutical companies. The investment decision aligned with Debiopharm’s vision is to invest in start-ups that change the way that patients are treated and the way that drugs are developed. The corporate fund specializes in disruptive digital health investments while actively helping the companies bring their technologies to a clinical reality.

"It’s really thrilling to see our start-up investment companies grow and move to the next step of reaching more of the patients who can benefit from their innovation," explained Tanja Dowe, CEO of Debiopharm Innovation Fund SA and former Chairwoman of Kaiku Health. "The growing patient base through Elekta will strengthen Kaiku Health’s capabilities to develop patient-centric and outcome-driven solutions for cancer patients, in some cases in collaboration with pharmaceutical companies. In the era of precision medicine, these outcomes play an important role for the development of pharmaceutical therapies."

Debiopharm remains an active investor in digital health start-ups around the world. As the chairwoman of the board, Debiopharm Innovation Fund SA CEO, Tanja Dowe provided strategic and practical guidance to sustain and grow the start-up’s network, pharmaceutical know-how and international impact.

Kaiku Health has been particularly implicated in immunooncology, where faster detection of predictive symptoms can lead to improved toxicity management. The platform offers cancer patients the ability to stay better connected to their medical team during and after therapy. This is accomplished via a user-friendly app that captures the experience and symptoms of patients through basic health-related questions. The patient-reported information allows caregivers to assess the effectiveness of treatments promptly, to detect and treat health issues early and to adapt the treatment regimen immediately if necessary and can in addition be used to improve clinical study experience. Research shows that digital monitoring can have a beneficial effect on patient health comparable to that of a new medication, revealing the potential impact of this affordable, easy-to-use technology.

"Personalized digital health intervention to every cancer patient – this has been our vision from the very beginning. Measuring what matters to patients is paramount for value-based healthcare," expressed Lauri Sippola, CEO of Kaiku Health. "We are grateful for Debiopharm’s active support in developing our digital therapeutics pipeline as our Series A lead investor in 2018. We are encouraged that through this acquisition by Elekta, that now even more patients can have the possibility to receive more personalized cancer care through Kaiku technology."

Recently, Kaiku Health’s interventions have also been implemented to support the efficient monitoring of COVID-19 patients, including a specific symptom monitoring module in co-operation with the leading Swiss university hospital group, the Geneva University Hospitals (HUG).

Rigel to Present at the Jefferies Virtual Healthcare Conference

On May 26, 2020 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that Raul Rodriguez, the company’s president and chief executive officer, is scheduled to present a company overview at the Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020 at 1:30 p.m. Eastern Time (Press release, Rigel, MAY 26, 2020, View Source [SID1234558508]).

To access the live and subsequently archived webcast, go to the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.