Midatech Pharma Plc Preliminary results for the year ended 31 December 2019

On June 16, 2020 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and bio-distribution of medicines reported its audited preliminary results for the year ended 31 December 2019 (Press release, Midatech Pharma, JUN 16, 2020, View Source [SID1234562738]).

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Financial highlights

·Total gross revenue(1) for the year of £0.7m (2018: £1.9m, 2017: £1.0m).

·Statutory revenue(2) for 2019 of £0.3m (2018: £0.1m, 2017: £0.1m).

·Subscription, Placing and Open Offer in February 2019 raised £12.3m (net) and Registered Direct Offering in the US in October 2019 raised $2.5m (£1.8m) (net).

·Receipt of €3.6m (£3.1m) (net) non-dilutive Reindus loan and award of Guazatu loan of €1.5m.

·Provisional award of a GlioKIDS grant of €2.7m (£2.3m), subject to confirmation of Midatech’s status as an SME, to support a Phase II trial of MTX110.

·Cash and deposits at 31 December 2019 of £10.9m (2018: £2.3m, 2017: £13.2m).

·Net loss from continuing operations of £9.1m (2018: £10.4m loss, 2017: £11.7m loss) with net cash inflow in the year of £8.4m (2018: £10.9m outflow, 2017: £4.1m outflow).

·Tax credit receivable of £1.8m (2018: £1.9m, 2017: £1.2m).

1)Total gross revenue represents collaboration income from continuing operations plus grant revenue.

2Statutory Revenue represents total gross revenue, excluding grant revenue.

Operational highlights

·First substantive licensing agreement with China Medical System Holdings Ltd ("CMS") for the Group’s pipeline products for Greater China accompanied by an £8.0m strategic investment in the Company, as part of a Subscription, Placing and Open Offer executed in February 2019.

·MTX110 received orphan drug designation for malignant glioma including DIPG from the FDA.

Post period end highlights

·In January 2020, a study of subcutaneous administration of MTD201 compared with traditional intramuscular administration in healthy volunteers showed similar pharmacokinetics and bioavailability, offering the potential for a differentiated, more patient-friendly product profile.

·In March 2020, an exploratory study was initiated by Columbia University in five patients with DIPG using an alternative convection enhanced delivery system.

·Also in March 2020, following a General Meeting, the Company’s ordinary shares of £0.00005 each were consolidated on a one-for-20 basis into ordinary shares of £0.001 each. At the same meeting a resolution was passed to change the ratio of the Company’s American Depositary Receipts ("ADRs"). This will change from one ADR representing 20 Existing Ordinary Shares to one ADR representing five new ordinary shares.

·On 31 March 2020, the Company announced a wide-ranging strategic review including termination of MTD201, closure of the Company’s Bilbao operations and a re-alignment of the Board.

·On 20 April 2020, the Company announced an update to the strategic review including the appointment of an adviser and start of a ‘formal sale process’ under the Takeover Code.

·On 18 May 2020, the Company announced that it had raised gross proceeds of £4.3m (£3.8m net of expenses) in a combined UK Placing and Registered Direct Offering in the US. The combined offerings resulted in the issuance of 15.8 million new Ordinary Shares and 16.5 million new Warrants.

·On 8 June 2020, the Company received a letter sent on behalf of Secura Bio, Inc. ("Secura Bio"), dated 1 June 2020, purporting to terminate a License Agreement, dated 5 June 2017 (the "Secura License Agreement"), by and between Midatech Limited and Novartis AG, which Novartis AG subsequently transferred to Secura Bio. Pursuant to the Secura License Agreement, Midatech Limited was granted a non-exclusive worldwide, sublicenseable license to certain patents of panobinostat, the active pharmaceutical ingredient of the Company’s development product MTX110. Midatech Limited’s rights are limited to the treatment of brain cancer in humans, administered by convection-enhanced delivery. The Company plans to continue to pursue development of MTX110 and the strategic review process previously disclosed. The Company is also reviewing with its outside counsel remedies it may have if Secura Bio does not withdraw the notice and otherwise cease to interfere with its ongoing business and strategic review process, which the Company has formally requested. The Company is evaluating available actions to protect its rights under the Secura License Agreement and its assets.

Stephen Stamp, CEO and CFO commented "This has been an extremely difficult period for Midatech with the termination of in-house development of our lead programme, closure of our Bilbao operations and the loss of 47 jobs, over two-thirds of our employees. I should like to recognise the professionalism of the team in making these difficult decisions and the grace with which they have been accepted. Our focus now is to evaluate all available options for extracting maximum value from Midatech’s platform technologies."

C4 Therapeutics Raises $170 Million Financing to Bring Robust Pipeline of Protein Degraders to Clinical Proof-of-concept and to Advance Proprietary Platform

On June 16, 2020 C4 Therapeutics, Inc. (C4T), a biotechnology company pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation, reported the closing of a $170 million financing, including $150 million in Series B equity co-led by existing investor Cobro Ventures and new investor Perceptive Advisors and $20 million in venture debt by Perceptive Advisors (Press release, C4 Therapeutics, JUN 16, 2020, View Source [SID1234562445]). Additional new equity investors in the round included Adage Capital Management, Axil Capital, Bain Capital Life Sciences, Commodore Capital, 3E Bioventures Capital, HBM Healthcare Investments, Lightchain Capital, Logos Capital, Mizuho Securities Principal Investment, Nextech, RA Capital Management, RTW Investments, Sphera Funds Management, Taiwania Capital Management, Yonjin Venture, and funds and accounts managed by T. Rowe Price Associates, Inc and Janus Henderson Investors. Existing investors also participated.

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C4T will use the proceeds to advance multiple degrader drug candidates to human proof-of-concept and to expand the Company’s capabilities. C4T has invested significantly in its TORPEDO platform, which combines a robust chemistry engine, proprietary assays, and high throughput screening with predictive modeling for accelerated, informed, and efficient discovery and design of high-quality drug candidates.

"This funding comes at a significant juncture, as our company is moving to a clinical stage. We plan on filing our first IND by the end of this year and expect to have four drug candidates in the clinic by the end of 2022. We have a deep pipeline addressing a diverse set of oncology indications that provides us with significant optionality. Protein degraders allow for more potent and durable pharmacologic responses than traditional inhibitors, and we bring a differentiated approach to this transformative modality through our proprietary TORPEDO platform," said Marc Cohen, Co-Founder, Chairman and CEO of C4 Therapeutics. "We look forward to advancing our programs with the goal of bringing new therapeutics to patients suffering from life-threatening diseases and are thrilled to have attracted top-tier life science investors to our company in this very oversubscribed round."

"C4 Therapeutics is a pioneer in this exciting and promising new protein degradation space," said Adam Stone, Chief Investment Officer of Perceptive Advisors and co-lead of this financing. "With their strong science and world class team we have no doubt that they will be able to bring powerful new therapeutics to patients and we are excited to collaborate with C4T on this important mission."

"C4T remains at the forefront of this novel modality with its proprietary platform validated by high-value strategic partnerships," added Todd Kaloudis, Managing Director at Cobro Ventures, co-lead of this round. "We are proud to support C4T in its mission to destroy disease-causing proteins and deliver breakthrough treatments for significant unmet medical needs."

Jefferies and Locust Walk served as transaction advisors to the Company in the Series B financing.

VA and GO2 Foundation Partner to Improve Outcomes for Veterans at Risk of Lung Cancer

On June 16, 2020 Bonnie J Addario Lung Cancer Foundation reported that A historic milestone was reached today with the exciting announcement that the Department of Veterans Affairs (VA) and GO2 Foundation for Lung Cancer (GO2 Foundation) have established a formal partnership to advance lifesaving screening and care for our military men and women at greater risk for lung cancer (Press release, Bonnie J Addario Lung Cancer Foundation, JUN 16, 2020, View Source [SID1234561263]). One of GO2 Foundation’s core priorities is educating people at risk for lung cancer and facilitating access to early detection screenings and care that can save lives. Working to better support Veterans who are at elevated risk and incidence for lung cancer than the civilian population has been a key focus of our organization for years.

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This partnership allows GO2 Foundation to offer the VA educational and technical assistance and to collaborate on ways to improve Veterans’ access to high quality screening and care in communities where they live. This partnership will strengthen and accelerate efforts to change the reality of lung cancer for our service members. It will help break down barriers to save lives.

The announcement could not come at a better time as lung cancer advocates are gathering virtually at the 2020 Lung Cancer Voices Summit to call on Congress to increase funding for lung cancer research. As more breakthroughs are achieved, the VA-GO2 Foundation partnership picks up the baton and carries it forward to Veterans who will benefit from these life-saving endeavors.

Pulse Biosciences, Inc. Announces Closing of $30 Million Rights Offering

On June 16, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported the closing of its oversubscribed rights offering and the final results thereof (Press release, Pulse Biosciences, JUN 16, 2020, View Source [SID1234561168]).

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The rights offering resulted in the sale of 4,279,600 units consisting of one share of the Company’s common stock, par value $0.001 per share, and 0.15 warrants to purchase shares of common stock (the "Units") at a price of $7.01 per Unit. The common stock and warrants comprising the Units separated upon the closing of the rights offering and were issued individually. 4,279,600 shares of common stock and 641,571 warrants were issued in the offering. The Company received aggregate gross proceeds from the rights offering of $30 million. Total basic subscriptions and over-subscriptions received were almost $56.0 million. Additional proceeds of up to $4.5 million may be received through the exercise of warrants issued in the rights offering, if exercised. Each warrant is exercisable for one share of the Company’s common stock at an exercise price equal to $7.01. Warrants are exercisable immediately and expire on the fifth anniversary of the completion of this rights offering.

Investors who participated in the rights offering should expect to see the shares and warrants issued to them in book-entry, or uncertificated, form. Any excess subscription payments received by Broadridge Corporate Issuer Solutions, Inc. (the "Subscription Agent") will be returned by the Subscription Agent to investors, without interest or penalty, as soon as practicable.

After giving effect to the issuance of 4,279,600 shares of common stock in the rights offering (but excluding up to 641,571 shares of common stock underlying the warrants issued in the rights offering), the Company has 25,149,043 shares of common stock issued and outstanding.

Robert W. Duggan, the Chairman of the Company’s Board of Directors and the beneficial owner of approximately 43% of the Company’s outstanding common stock prior to this rights offering participated in the rights offering and purchased an aggregate of 2,561,873 Units. After giving effect to the rights offering, Mr. Duggan is the beneficial owner of approximately 46% of the Company’s outstanding common stock.

"Once again, I want to thank all participating stockholders, as well as the Board of Directors and the management team. In addition to participation by the Company’s Chairman, Robert Duggan, insider participation totaled approximately $1.1 million. We are grateful for the support and confidence that led us to the successful closing of this offering," said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. "The completion of this rights offering provides funding for the continued progress towards commercialization of our proprietary CellFX System and the introduction our platform Nano-Pulse Stimulation technology first to the dermatology market. We are excited about the opportunity ahead and confident we can execute our strategy to create value for stockholders in our next phase of growth."

"I am very pleased with the execution of this Rights Offering. It was our priority to provide stockholders the opportunity to participate in funding the Company in an efficient and minimally dilutive manner," added Robert Duggan, Chairman of the Company’s Board of Directors. "I see tremendous value in the long-term opportunity for Nano-Pulse Stimulation technology and its potential to treat a variety of unmet needs across medical specialties. We are steadfast in our commitment to health innovation as we make this technology accessible to patients in future."

A registration statement, as amended, relating to the Units was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on May 8, 2020. A prospectus relating to the offering was filed with the SEC on May 14, 2020 and is available on the SEC’s website. Subscription rights that were not exercised by 5:00 p.m. Eastern Time on June 8, 2020 have expired.

Sanofi Invests $679.4 Million in Two French Sites for Vaccine Research and Production

On June 16, 2020 Sanofi reported to increase its vaccines research and production capabilities (Press release, BioSpace, JUN 16, 2020, View Source [SID1234561165]). As part of the plan it will invest $679.4 million (€610 million) to create a new production site and a research center, both in France, both dedicated to vaccines.

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"Sanofi’s heart beats in France," said Sanofi’s chief executive officer Paul Hudson in a statement. "We have a long history and exceptional teams working throughout the country, embodying our strong values. By investing in a new industrial site and a R&D center, Sanofi positions France at the core of its strategy, aiming to make France a world-class center of excellence in vaccine research and production."

The company’s Evolutive Vaccine Facility (EVF) will be based in Neuville sur Saone. This industrial site will leverage the latest innovative vaccine production technologies. The company will invest €490 million over a five-year period, with plans to create 200 new jobs.

Sanofi Pasteur is Sanofi’s vaccine company and it will utilize the manufacturing site to handle any new pandemics. Sanofi indicates that EVF "is a new type of factory designed around a central unit housing several fully digital production modules that make it possible to produce three to four vaccines simultaneously, versus only one in current industrial sites. This modularity will make it possible to prioritize the production of a specific vaccine in a more timely manner based on public health issues."

Of the total funding, €120 million will go to form a new R&D center at the Sanofi Pasteur site in Marcy-l’Etoile to develop future vaccines. It too will be a state-of-the-art digital facility with specialized laboratories. Sanofi indicates it plans for the facility to become a world reference for preclinical research and pharmaceutical and clinical development.

Hudson added, "Sanofi is a major healthcare player in France, in Europe, and worldwide. It is our responsibility to focus our resources and expertise against the current pandemic, but also to invest in preparing for future ones. We welcome the ongoing collaboration and commitment of the French authorities who we have been working alongside with the last several months to achieve this."

Sanofi, in collaboration with GlaxoSmithKline, is approaching the development of two different COVID-19 vaccines with two different technological approaches. The first, with GSK, is using recombinant DNA technology, which would allow for manufacturing very large quantities of antigens, the proteins that are injected to stimulate the immune system. The second is messenger RNA technology in collaboration with TranslateBio. This is a new technology also being utilized by U.S.-based Moderna and Germany-based BioNTech, which is collaborating with Pfizer.

Sanofi says it is committed to making its vaccine accessible to "all and around the world."

On April 14, Sanofi and GSK signed a letter of intent to collaborate on the COVID-19 vaccine using technology from both companies. Sanofi is contributing its S-protein COVID-19 antigen, which utilizes recombinant DNA technology. This allows for an exact genetic match to proteins found on the virus surface. The DNA sequence that codes for the antigen has been combined into the DNA of the baculovirus expression program, which Sanofi uses for its recombinant influenza product in the U.S.

GSK is contributing its pandemic adjuvant technology, which can decrease the amount of vaccine protein required per dose, which allows for more manufacturing volume.

At the time, Emma Walmsley, chief executive officer of GSK, said, "This collaboration brings two of the world’s largest vaccines companies together. By combining our science and our technologies, we believe we can help accelerate the global effort to develop a vaccine to protect as many people as possible from COVID-19."

The deal with TranslateBio was signed earlier, on March 27. That deal leverages an existing agreement from 2018 to develop mRNA vaccines for infectious diseases. The primary aspect of that agreement is TranslateBio is producing multiple mRNA constructs using its technology platform to discover, design, and manufacture several SARS-CoV-2 vaccine candidates. Sanofi will provide its vaccine expertise and its external research network to advance vaccine candidates.