PHARMAXIS STRENGTHENS CLINICAL DEVELOPMENT ONCOLOGY CAPABILITY WITH THE APPOINTMENT OF DR JANA BASKAR AS CHIEF MEDICAL OFFICER

On July 1, 2022 Pharmaxis Limited (ASX:PSX), a clinical stage drug development company developing novel therapies to treat inflammatory and fibrotic diseases, reported the appointment of Dr Jana Baskar to the role of Chief Medical Officer (Press release, Pharmaxis, JUL 1, 2022, View Source;utm_campaign=Appointment%20of%20Jana%20Basker&utm_content=Appointment%20of%20Jana%20Basker+CID_bca45eeb80226d41b6b06560a3261988&utm_source=Campaign%20Monitor&utm_term=View%20Full%20Media%20Release [SID1234616441]).

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Dr Baskar is a highly experienced executive who has worked in both pharmaceutical and contract research companies.

"We are delighted to welcome Dr Baskar to Pharmaxis, where his deep experience leading clinical programs will be an asset to the continued advancement of our pipeline," commented Gary Phillips, Chief Executive Officer of Pharmaxis. "Dr Baskar brings significant oversight, clinical development and strategic expertise, having previously guided numerous programs through all phases of development. His extensive background and experience will be particularly valuable as the Company progresses its lead asset, PXS‐5505, towards clinical proof of concept in myelofibrosis and other oncology indications."

Dr Jana Baskar has over two decades of experience including overseeing more than 70 phase I‐III trials of oncology treatments in his 6 years as Medical Director at Novartis Oncology in Australia. In his most recent role, he served as Medical Director for IQVIA in Australia and New Zealand where he also co‐ chaired the IQVIA ANZ Oncology Advisory Board providing strategic advice to Biopharma companies. Dr Baskar received his Bachelor of Medicine degree (MBBS) from the University of Western Australia. He holds a Master of Medical Science in Drug Development from the University of New South Wales, Sydney (MMedSc) and a Masters of Business Administration (MBA) from the Australian Graduate School of Management.

Pharmaxis founding scientist and Medical Director, Dr Brett Charlton, is retiring after more than 20 years’ service with the company during which time he has overseen development programs that lead to two products achieving global regulatory approval and the transition of several pipeline products into clinical development including Pharmaxis’ two lead assets in myelofibrosis (PXS‐5505) and scarring (PXS‐6302). Page 2 of 3 Gary Phillips said, "I’d like to recognise and sincerely thank Dr Charlton for his extensive contribution to the Pharmaxis business and to advances in patient care. His experience and knowledge of transitioning drugs into early phase development has been extremely valuable and we will continue to seek his advice in a part time consultancy capacity until the end of 2022."

UCLB spinout, KIT-AR, announces €2m in seed stage funding round

On July 1, 2022 KIT-AR, the augmented worker platform for the manufacturing industry, reported the completion of a €2m seed stage funding round (Press release, UCLB, JUL 1, 2022, View Source [SID1234616439]).

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This investment was co-led by Armilar Venture Partners and Caixa Capital Risc, with participation from RKKVC and Techtree fund (managed by Iberis Semper) and follow-on investment from Sintef Venture V and Best Horizon.

This round of financing will help KIT-AR push onwards with its goal to become the premier augmented worker platform for the manufacturing industry.

Incorporated in the United Kingdom, with a subsidiary in Portugal, KIT-AR has strong roots in applied research and innovation having spun out of UCL (University College London) and SINTEF, the largest research institute in Norway.

Marina Santilli, Associate Director of Physical Science and Engineering at UCLB, said: "Having followed the development of the team and the evolution of the product platform from its initial roots as a collaborative research project between UCL computer scientists and SINTEF engineers, I am delighted that KIT-AR has secured this significant seed funding award. I look forward to seeing the company evolve and grow even further."

Scandion Oncology announces preliminary outcome of its rights issue

On July 1, 2022 The subscription period in Scandion Oncology’s ("Scandion" or the "Company") reported that rights issue of shares (the "Rights Issue") ended today, July 1, 2022 (Press release, Scandion Oncology, JUL 1, 2022, View Source,c3595569 [SID1234616437]). The preliminary outcome of Scandion’s Rights Issue of shares of up to SEK 93.7 million indicates that shares, corresponding to approximately 80% of the Rights Issue, were subscribed for, including subscriptions by guarantors . Through the Rights Issue, Scandion raises approx. SEK 75 million before deduction of issue related costs.

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NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO, THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURE.

"In the current market environment we are very pleased with securing funding of Scandion, which will put the Company in a strong financial position and enable us to execute on our development plans as described in the prospectus", says Bo Rode Hansen, President & CEO of Scandion

Preliminary outcome

The Rights Issue comprised a maximum of 10,711,848 ordinary shares. The preliminary outcome of Scandion’s Rights Issue of shares shows that 1,396,886 shares, corresponding to approx. 13% of the Rights Issue, has been subscribed for by exercise of subscription rights (incl. subscription undertakings). Additionally, 55,750 shares, corresponding to approx. 0,5% of the Rights Issue, were subscribed for without preferential rights. 7,118,792 shares, corresponding to approx. 66.5% of the Rights Issue, were subscribed by guarantors. Through the Rights Issue, Scandion raises approx. SEK 75 million before deduction of issue related costs.

Notification regarding allocation

Allocation of shares has been made according to the principles described in the prospectus which was published in conjunction with the Rights Issue. Subscribers who are allocated shares subscribed for without preferential rights will receive an allocation notice in the form of a settlement note. Payment for such shares is to be made according to the instructions on the settlement note.

Number of shares and share capital

When the Rights Issue has been registered with the Danish Business Authority, the total number of shares in Scandion will based on the preliminary outcome amount to 40,706,972 shares and the share capital amount to DKK 2,991,962.4420.

Publication of final outcome

The information above is preliminary, the final outcome of the Rights Issue is expected to be published on July 4, 2022.

Trading in BTA

Trading in BTA (paid subscribed shares) is currently conducted on Nasdaq First North Growth Market Stockholm, which will cease once the issue has been registered with the Danish Business Authority. BTA’s will subsequently be converted into ordinary shares.

Advisers
Redeye AB acts as financial adviser and Horten Advokatpartnerselskab (as to Danish law) and Advokatfirman Schjødt (as to Swedish law) act as legal advisers in connection with the Rights Issue. Hagberg & Aneborn Fondkommission AB acts as the issuing agent in the Rights Issue.

This information is such information as Scandion is obliged to make 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 22:00 CET on July 1, 2022.

Regeneron Completes Purchase of Sanofi’s Stake in Libtayo® (cemiplimab)

On July 1, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it has completed the acquisition of Sanofi’s stake in Libtayo (cemiplimab), providing Regeneron with exclusive worldwide development, commercialization, and manufacturing rights to the medicine originally discovered in Regeneron’s laboratories (Press release, Regeneron, JUL 1, 2022, View Source [SID1234616436]). The intent to purchase Libtayo was announced on June 2, 2022.

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In 2015, Regeneron and Sanofi entered into the Immuno-oncology License and Collaboration Agreement whereby the companies split Libtayo’s worldwide operating profits equally and co-commercialized Libtayo in the U.S., with Sanofi solely responsible for commercialization outside the U.S. With today’s closing, Regeneron will now record 100% of global net sales and expenses for Libtayo.

Regeneron intends to update its full year 2022 financial guidance to reflect the Libtayo purchase during its second quarter 2022 earnings announcement in early August.

Anticipated Impact to Second Quarter 2022 Financial Results from Recently Completed Business Development Transactions
There is no financial or accounting impact to second quarter 2022 financial results as a result of the Libtayo transaction.

On May 31, 2022, Regeneron announced that it had successfully acquired Checkmate Pharmaceuticals, Inc. for a total equity value of approximately $250 million. As a result of the Checkmate acquisition, Regeneron expects to record in the second quarter of 2022 an acquired in-process research and development (IPR&D) charge of approximately $195 million, which would negatively impact GAAP and non-GAAP diluted earnings per share by approximately $1.70. This acquired IPR&D charge and its resultant impact on diluted earnings per share represent unaudited estimates that have not been subject to Regeneron’s quarterly financial statement closing procedures, and therefore actual amounts could differ from what the Company currently anticipates.

GSK completes acquisition of Sierra Oncology

On July 1, 2022 GSK plc (LSE/NYSE: GSK) reported it has completed the acquisition of Sierra Oncology, Inc. (Sierra Oncology), a California-based biopharmaceutical company focused on targeted therapies for the treatment of rare forms of cancer (Press release, GlaxoSmithKline, JUL 1, 2022, View Source [SID1234616435]). The acquisition was approved by Sierra Oncology’s shareholders on 29 June 2022.

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As previously announced, the acquisition of Sierra Oncology includes momelotinib, a late-stage potential new medicine with a unique dual mechanism of action that may address the critical unmet medical needs of myelofibrosis patients with anaemia. In addition, momelotinib complements GSK’s Blenrep (belantamab mafodotin); the acquisition builds on the company’s expertise in haematology and aligns with GSK’s strategy of building a strong portfolio of specialty medicines and vaccines. If approved, momelotinib will contribute to GSK’s growing specialty medicines business, with a US launch anticipated in 2023.

Luke Miels, Chief Commercial Officer, GSK, said: "This acquisition expands our innovative oncology portfolio, demonstrating our commitment to improving patient outcomes and creating value for shareholders. We now have a late-stage differentiated molecule in momelotinib, which could potentially address a significant unmet need in myelofibrosis patients with anaemia. Our focus is now on execution."

In June 2022, Sierra Oncology presented the complete data from the MOMENTUM phase III trial at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The trial met all its primary and key secondary endpoints, demonstrating that momelotinib achieved a statistically significant and clinically meaningful benefit on symptoms, splenic response, and anaemia. Sierra Oncology submitted a New Drug Application to the US Food and Drug Administration in June, and GSK anticipates a regulatory submission in Europe in the second half of 2022.

Financial considerations

Upon completion of the acquisition, GSK acquired all outstanding shares of Sierra Oncology for $55 per share in cash, representing an approximate total equity value of $1.9 billion (£1.6 billion at current exchange rates). The per-share price represented a premium of approximately 39 per cent to Sierra Oncology’s closing stock price on 12 April 2022 and approximately 63 per cent to Sierra’s volume-weighted average price (VWAP) over the last 30 trading days.

About myelofibrosis

Myelofibrosis is a rare blood cancer that results from dysregulated JAK-STAT signalling and is characterised by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anaemia. From prior studies with momelotinib, we know approximately half of myelofibrosis patients are moderately to severely anaemic when eligible for JAK inhibitor treatment. Furthermore, currently approved JAK inhibitors only address symptoms and splenomegaly and are myelosuppressive. This can lead to worsening anaemia, resulting in dose reductions that potentially reduce treatment effect.

Myelofibrosis affects approximately 20,000 patients in the US, with approximately 40% of patients already anaemic at time of diagnosis and nearly all patients estimated to eventually develop anaemia.[1],[2] Patients treated with the most commonly used JAK inhibitor will often require transfusions, and more than 30% will discontinue treatment due to anaemia.[3] Anaemia and transfusion dependence are strongly correlated with poor prognosis and shortened survival.[4]

About momelotinib

Momelotinib has a differentiated mode of action with inhibitory ability along three key signalling pathways: activin A receptor, type I (ACVR1)/activin receptor-like kinase-2 (ALK2), Janus kinase (JAK) 1, and JAK2. This activity may lead to beneficial treatment effects on anaemia and reduce transfusion dependence while treating myelofibrosis symptoms and splenic response.

GSK in oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, tumor cell targeting therapies and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates and cell therapy, either alone or in combination.