On September 29, 2020 Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), "Mereo" or "the Company", a clinical stage biopharmaceutical company focused on oncology and rare diseases, reported unaudited interim financial results for the six months ended June 30, 2020 and provides a corporate update (Press release, Mereo BioPharma, SEP 29, 2020, View Source [SID1234568616]).

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Denise Scots-Knight, Chief Executive of Mereo, said: "Following the closing of our $70 million financing in the first half of 2020 we have focussed on executing our strategy, advancing etigilimab ("Anti-TIGIT") for the treatment of solid tumors alongside developing our rare disease portfolio. We remain on track to initiate a Phase 1b/2 study of etigilimab (Anti-TIGIT) in combination with an anti-PD-1 in a range of solid tumor types in Q4 2020. Our rare disease portfolio includes setrusumab for osteogenesis imperfecta which we plan to partner prior to the initiation of a pivotal Phase 3 study, and alvelestat which is being investigated in an ongoing Phase 2 proof-of-concept study for alpha-1 anti-trypsin deficiency. We were also pleased to have recently announced the initiation of a Phase 1b/2 placebo-controlled study of alvelestat in COVID-19 infected patients following the scientific publications demonstrating the involvement of neutrophil elastase in COVID-19 infection pathways. We also continue to advance other discussions with potential partners to optimize the value of our broader product portfolio."

Recent Highlights and Upcoming Milestones

Etigilimab (Anti-TIGIT) for Solid Tumors

On track to initiate a Phase 1b/2 study of etigilimab in combination with an anti-PD-1 in a range of solid tumor types in Q4 2020.

Setrusumab for Osteogenesis Imperfecta (OI)

Receipt of FDA Rare Pediatric Disease Designation on September 23, 2020.
Following regulatory discussions in 1H 2020, both the FDA and EMA have agreed on the principles of a design of a single Phase 3 pediatric pivotal study in OI.
Intend to partner setrusumab prior to conducting a pivotal trial of setrusumab in children with severe OI. Partnering discussions are well underway with a range of potential structures including options for Mereo to retain commercial rights in certain regions.

Alvelestat for Severe Alpha-1 Antitrypsin Deficiency (AATD)

Topline data from an ongoing Phase 2 proof of concept study remains on track for 2H 2021.
Announced the initiation of a Phase 1b/2 placebo-controlled clinical trial to evaluate the safety and efficacy of alvelestat in hospitalized, adult patients with moderate to severe COVID-19 respiratory disease.
Investigator-sponsored studies underway in AATD and in the orphan disease, bronchiolitis obliterans syndrome (BOS).

Partnering Discussions Continue for Portfolio of Other Clinical-Stage Programs

Leflutrozole for hypogonadotropic hypogonadism (HH)
º Partnering discussions continuing based on development in male infertility.
Acumapimod for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
º Discussions continuing on separate financing for the Phase 3 study agreed with the FDA and EMA.
Corporate

Appointment of Dr. Brian Schwartz and Dr. Jeremy Bender as Non-Executive Directors and departure of Mr Paul Blackburn as Non-Executive Director effective October 1, 2020
Dr. John Lewicki appointed as Chief Scientific Officer and Dr. Ann Kapoun appointed as Head Translational R&D in July 2020.
Financial Highlights

Cash resources of £56.8 million as at June 30, 2020 (June 30, 2019 £36.1 million).
£11.8 million raised in equity and debt in Q1 2020.
Additional $70 million (£56 million) raised in PIPE in Q2 2020.
Cash runway to early 2022.

Conference Call Information
Mereo will host a live conference call and webcast today at 8:00 a.m. EDT / 1:00 p.m. BST to discuss the Company’s financial results and provide a corporate update.

Dial-in numbers: (866) 688-2942 (U.S.) or +1 (561) 569-9224 (U.K./International)

Conference ID number: 9572439

A live and archived webcast may be accessed by visiting the Investors sections of the Company’s website at View Source The archived webcast will remain available on the Company’s website following the live call.

On September 29, 2020 Cellaria Inc (Wakefield, MA, USA), a scientific innovator with breakthrough tools for cancer research, reported that it has introduced three next generation Pancreatic Cancer cell lines, substantially boosting the value of ​in vitro​ methods in the development of more effective therapies (Press release, Cellaria, SEP 29, 2020, View Source [SID1234568099]). Difficult to detect and with a poor survival rate, Pancreatic Cancer remains a primary and illusive therapeutic target for researchers. The new cell models are scalable and stable, securely linked to specific patient tumor samples and supported by Cellaria quality control certifications, which include full cell line authentication. They directly facilitate more clinically relevant, translatable research and represent a major step forward for academic and industrial researchers working to advance more effective, personalized medicine and lead drug candidates.

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‘Legacy cell lines are a crucial tool for cost-effective ​in vitro​ studies, but most do not securely represent the heterogeneity of the original patient tumor,’ said David Deems, CEO, Cellaria Inc. "Genetic drift, selective overgrowth and/or contamination are recognized issues that erode the relevance of commercial lines, thereby compromising progress. In contrast, our novel cell models are extremely stable and have a strong, robustly authenticated connection to specific patient tumors. They offer breakthrough reproducibility, rigor and relevance in both clinical studies and drug discovery."

Pancreatic cancer tumors are elusive in conforming to standard definitions and tend to morph and metastasize into different cancers following treatment. Cellaria’s three new cell models – "Stew", "Chocolate", and "Basket" – are derived from patients diagnosed with pancreatic adenocarcinoma (the most common form of Pancreatic Cancer), and vary with respect to factors such as gender, ethnicity, age, treatment history, and diagnosis.​ ​As a result, they enable

researchers to closely align their studies with a specific patient cohort, with defined molecular targets and biomarkers. All are provided with protocols for preserved biomarker expression and a Certificate of Analysis (COA) attesting their growth characteristics. Beyond supporting optimal application of the cell line, the COA meets growing requirements within the research community for demonstrable cell line authentication.

‘In-depth scientific know-how is a hallmark of the Cellaria approach,’ said David Deems. ‘All our cell models are subject to extensive characterization assays including genomic and biomarker analysis, gene expression and protein profiling. Furthermore, we have data showing response to at least three approved drug therapies for each line. This information is a powerful aid to gathering useful, actionable data from the outset for new or established research groups. We’re delighted to add these new products to our established portfolio for breast, lung, colon, and ovarian cancers, to accelerate the progress of therapeutic and basic science towards a treatment for this challenging condition.’

Cellaria cell models for a range of cancers have already demonstrated proven value in ​in vitro studies. Find out more about the potential impact of the Stew, Chocolate and Basket at: www.cellariabio.com​ or call 978-720-8051.
About Cellaria Inc.

Cellaria Inc’s mission is to develop and build more informative disease cell models to revolutionize and accelerate the search for a cure. The company provides a suite of products and services that are actionable, replicable and that originate from a patient’s unique specimens. ​With 7 years of research and development, Cellaria’s solutions better enable disease researchers to select promising compounds and ultimately identify the most effective treatment for each patient’s needs. This helps lead the research community to more personalized therapeutics, revolutionizing and accelerating the search for a cure and/or personalized treatments.

On September 29, 2020 Polyphor AG (SIX: POLN) reported the closing of the previously announced exclusive licensing agreement with Fosun Pharma for balixafortide in China (Press release, Polyphor, SEP 29, 2020, View Source [SID1234567844]). As a result of closing the transaction, Polyphor received the agreed upfront payment of $15 million.

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Under the terms of the agreement, Polyphor and Fosun Pharma will develop and commercialize balixafortide for the Chinese market with an initial focus on metastatic breast cancer. China is projected to be the second largest market globally for breast cancer treatments. Additional cancer indications and combination therapies will be evaluated jointly by the companies. Polyphor retains all rights to balixafortide outside of China.

In addition to the upfront payment, Polyphor is eligible for additional development milestone payments of up to $19 million, sales milestone payments of up to $148 million plus up to mid-teen royalties on net sales achieved in the territory.

Fosun Pharmaceutical AG is a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co. Ltd ("Fosun Pharma", stock code: 600196.SH; 02196.HK), a leading healthcare company in China. It is listed on both the Shanghai Stock Exchange and the Hong Kong Stock Exchange.

On September 29, 2020 Dewpoint Therapeutics, the biomolecular condensates company, reported it has raised $77 million in a Series B financing (Press release, Dewpoint Therapeutics, SEP 29, 2020, View Source [SID1234567776]). The round was led by ARCH Venture Partners, with participation from new investors Maverick Ventures and Bellco Capital, and existing investors Leaps by Bayer, EcoR1 Capital, Polaris Partners, Samsara BioCapital, and Innovation Endeavors.

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"We are delighted to have ARCH Venture Partners lead this financing, and to welcome new investors into the condensate field," said Amir Nashat, managing partner of Polaris Partners and interim CEO of Dewpoint. "Our proprietary platform has already generated two significant external collaborations with Merck and Bayer, and today’s announcement underscores the interest in biomolecular condensates among investors with a track record of backing groundbreaking science."

Dewpoint’s proprietary condensates platform provides the ability to see and understand the complex interactions of biomolecular communities—and to find drugs that intervene in entirely new ways. Dewpoint will use proceeds from this round to further develop its platform and identify additional compounds that modulate these condensates.

"Dewpoint is the international center of gravity for developing and translating condensate science into drugs," said Kristina Burow, managing director at ARCH Venture Partners. "The company is well positioned to leverage novel insights into fundamental biology and utilize this groundbreaking biology to create transformational therapeutics."

"The Dewpoint team is a unique combination of executives who have brought more than ten drugs to market and researchers who have spent the last several years defining the science of condensates," said Oleg Nodelman, founder and portfolio manager of EcoR1 Capital. "This collection of drug hunters is a powerful force."

In addition to announcing its Series B, Dewpoint reported the addition of Giuseppe Ciaramella, Ph.D., to its Board of Directors. Ciaramella is president and chief scientific officer of Beam Therapeutics. Prior to Beam, Dr. Ciaramella served at Moderna, first as head of immunology and biotherapeutics, then as chief scientific officer of its infectious diseases division. Prior to Moderna, he held senior drug development roles at AstraZeneca, Boehringer Ingelheim, and Pfizer. Dr. Ciaramella holds a B.Sc. and Ph.D. in biochemistry and molecular biology from University College London.

Dewpoint’s proprietary platform uses high-throughput methods to test libraries of potential drugs for the desired effect, identifying compounds that modulate biomolecular condensates in specific diseases of immediate interest to Dewpoint and its partners. Approaches to modulating condensates that may positively impact disease include dissolving or forming condensates, modulating the composition of condensates, stabilizing condensates, and selective drug delivery into condensates.

In July 2020, Dewpoint announced an exclusive collaboration with Merck (MSD) to leverage Dewpoint’s proprietary biomolecular condensate platform for the development of a novel mechanism for the treatment of HIV. In November 2019, Dewpoint announced a collaboration with Bayer, combining the potential of Dewpoint’s condensate platform with Bayer’s small molecule compound library to develop new treatments for cardiovascular and gynecological diseases.

In addition to disease areas where Dewpoint has announced collaborations, the company is exploring potential therapeutic opportunities in oncology, neurodegeneration, metabolic disease, and immunology.

On September 29, 2020 Medtronic plc (the "Company") (NYSE:MDT) reported that its wholly-owned subsidiary Medtronic Global Holdings S.C.A. ("Medtronic Luxco") has closed a registered public offering (the "Offering") of €1,250,000,000 principal amount of 0.000% Senior Notes due 2023, €1,000,000,000 principal amount of 0.000% Senior Notes due 2025, €1,000,000,000 principal amount of 0.375% Senior Notes due 2028, €1,000,000,000 principal amount of 0.750% Senior Notes due 2032, €1,000,000,000 principal amount of 1.375% Senior Notes due 2040 and €1,000,000,000 principal amount of 1.625% Senior Notes due 2050 (collectively, the "Notes") (Press release, Medtronic, SEP 29, 2020, View Source [SID1234567775]). All of Medtronic Luxco’s obligations under the Notes are fully and unconditionally guaranteed by the Company and Medtronic, Inc. ("Medtronic, Inc."), a wholly-owned indirect subsidiary of Medtronic Luxco, on a senior unsecured basis.

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The net proceeds from the Offering are approximately €6.2 billion, after deducting underwriting discounts and commissions and estimated expenses related to the Offering payable by Medtronic Luxco. The net proceeds of the Offering will be used to repay €750 million aggregate principal amount of Medtronic Luxco’s Floating Rate Senior Notes due 2021 at maturity on March 7, 2021, which bore interest at a rate of 0% per annum at July 31, 2020, and to redeem the outstanding senior notes issued by Medtronic Luxco, Medtronic, Inc. and Covidien International Finance S.A., a wholly-owned indirect subsidiary of the Company as described below. Any remaining net proceeds of the Offering will be used for repayment of other indebtedness and general corporate purposes.

Today, the Company also announced that it intends to redeem all of the outstanding $1.5 billion aggregate principal amount of Medtronic, Inc.’s 3.150% Senior Notes due 2022, all of the outstanding $530.2 million aggregate principal amount of Medtronic, Inc.’s 2.750% Senior Notes due 2023, all of the outstanding $432.5 million aggregate principal amount of Medtronic, Inc.’s 3.625% Senior Notes due 2024, $810 million of the outstanding $2.7 billion aggregate principal amount of Medtronic, Inc.’s 3.500% Senior Notes due 2025, all of the outstanding $650 million aggregate principal amount of CIFSA’s 3.200% Senior Notes due 2022, all of the outstanding $309.5 million aggregate principal amount of CIFSA’s 2.950% Senior Notes due 2023 and all of the outstanding €1.5 billion aggregate principal amount of Medtronic Luxco’s 0.000% Senior Notes due 2021 (collectively, the "Redemption Notes"), in each case at the make-whole redemption prices specified in, and otherwise in accordance with, the indentures governing such Redemption Notes. The redemption date for the Redemption Notes will be October 29, 2020. This press release does not constitute a notice of redemption of any of the Redemption Notes.