Cyclica Forms Multi-Year and Multi-Project Drug Discovery Partnership with the Genome Institute of Singapore

On April 14, 2020 Cyclica reported a multi-year and multi-project collaboration with the Genome Institute of Singapore (GIS), a research institute under the Agency for Science, Technology and Research (A*STAR) (Press release, Cyclica, APR 14, 2020, View Source [SID1234556316]). Cyclica and GIS will carry out research efforts spanning from polypharmacology profiling to novel compound design for diverse drug discovery programs in oncology and related diseases . The collaboration will leverage GIS’ deep expertise in functional genomics, drug target discovery, and data analytics, and Cyclica’s AI-augmented and proprietary, Ligand Design and Ligand Express platform.

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The world-class team of scientists at GIS will conduct new compound design and off-target profiling to discover hits and subsequently develop the lead compounds. GIS will perform functional analyses and testing of compounds derived from Cyclica’s drug discovery platform against gene targets of interest to GIS. This cross-border collaboration provides a unique opportunity to tailor drug identification and development efforts in a holistic way that will enable the advancement of precision medicine. By empowering researchers and healthcare institutes who are at the forefront of innovation, Cyclica and GIS will pave the way to decentralize the drug discovery process and develop the next generation of improved treatments for patients based on the individual’s disease features.

Dr. Tam Wai Leong, Group Leader of Precision Oncology at GIS, said, "Applying AI-augmented approaches towards drug design is innovative and forward-looking. It has the potential to rapidly grow the arsenal of new drugs in our fight against diseases like cancer, especially in an era of genomic medicine where physicians and scientists can better define the underlying genetic and molecular drivers of cancers."

Professor Liu Jianjun, Deputy Executive Director at GIS, added, "Our ability to harness advanced genomic technologies has enhanced our discovery of genetic contributions to a spectrum of diseases, including cancer. Many of these important cancer drivers currently do not have drugs that target them. We believe that machine learning and deep learning models will shorten the time and cost for the development of new therapeutics, and are pleased to collaborate with Cyclica to further our efforts in developing therapeutics that can have a positive impact on patients."

"The calibre of genomic research at GIS is world-class. We are thrilled to have the opportunity to work with many leading scientists at GIS to innovate novel therapeutics, based on genomic discoveries, for a wide range of diseases. This opportunity to make a meaningful contribution and impact to patients are common values we share with our partners at GIS," said Dr. Verner De Biasi, VP, Global Head of Strategic Partnerships at Cyclica.

Clovis Oncology Announces Debt Exchange Transaction

On April 14, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that on April 14, 2020 it entered into a privately negotiated exchange agreement with a holder of its 2.50% Convertible Senior Notes due 2021 (the "2021 Notes") (Press release, Clovis Oncology, APR 14, 2020, View Source [SID1234556301]). Pursuant to the exchange agreement, Clovis Oncology will issue to such holder of the 2021 Notes approximately $36.05 million in aggregate principal amount of its currently outstanding series of 4.50% Convertible Senior Notes due 2024 (the "2024 Notes") in exchange for approximately $32.77 million in aggregate principal of 2021 Notes held by such holder. Clovis Oncology will not receive any cash proceeds from the issuance of these 2024 Notes. J.P. Morgan and BofA Securities acted as the exclusive agents to Clovis Oncology in connection with the exchange transaction.

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Clovis Oncology anticipates that the settlement of the exchange transaction will occur on or about April 20, 2020, subject to satisfaction of customary closing conditions. Upon completion of the exchange transaction, the aggregate principal amount of the 2021 Notes outstanding will be approximately $64.42 million, and the aggregate principal amount of 2024 Notes outstanding will be approximately $174.91 million.

About the 2024 Notes

The 2024 Notes issued in the exchange transaction will have substantially identical terms to the Clovis Oncology’s currently outstanding 2024 Notes and will be treated as a single series of securities with the currently outstanding 2024 Notes.

The 2024 Notes bear interest at a rate of 4.50% per annum, payable semi-annually in arrears on February 1st and August 1st of each year. The 2024 Notes will mature on August 1, 2024 unless earlier converted or repurchased. The holders of the 2024 Notes may convert their notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date at an initial conversion rate of 137.2213 shares of Clovis Oncology’s common stock per $1,000 principal amount of notes.

Clovis Oncology does not have the right to redeem the 2024 Notes prior to their maturity. Holders of the 2024 Notes may require Clovis Oncology to repurchase for cash all or part of their notes upon certain fundamental changes at a repurchase price equal to 100% of the principal amount of the 2024 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date, Clovis Oncology will, in certain circumstances, increase the conversion rate for a holder who elects to convert its 2024 Notes in connection with such corporate event.

The above summary of the terms of the 2024 Notes is qualified in its entirety by and should be read with the Indenture governing the 2024 Notes, filed with the Securities and Exchange Commission as Exhibit 4.5 to Clovis Oncology’s Annual Report on Form 10-K for the year ended December 31, 2019.

The 2024 Notes issuable in the exchange transaction and any shares of common stock issuable upon conversion of such 2024 Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law. Clovis Oncology does not intend to file a registration statement for resale of such 2024 Notes or the shares of common stock, if any, issuable upon conversion thereof. Accordingly, Clovis Oncology is offering the 2024 Notes only to persons who are both accredited investors (within the meaning of Rule 501 promulgated under the Securities Act) and qualified institutional buyers (as defined in Rule 144A under the Securities Act) in reliance on a private placement exemption from registration under the Securities Act. This press release does not constitute an offer to sell, or a solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offering would be unlawful.

ADDING MULTIMEDIA Velan Capital Agrees to Support Merger of Lantheus and Progenics

On April 14, 2020 Lantheus Holdings, Inc. (NASDAQ: LNTH) ("Lantheus"), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, and Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) ("Progenics"), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer, reported that Lantheus has entered into a Support Agreement (the "Support Agreement") with Velan Capital ("Velan") in connection with the proposed merger of Lantheus and Progenics (Press release, Lantheus Medical Imaging, APR 14, 2020, View Source [SID1234556317]).

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Velan is a stockholder of both Progenics and Lantheus and the Support Agreement provides that Velan will vote all of its Progenics stock and Lantheus stock in favor of the proposed merger of Lantheus and Progenics on the terms set forth in the Amended and Restated Agreement and Plan of Merger, dated as of February 20, 2020 (the "Amended Merger Agreement"). Velan has also agreed to abide by certain customary standstill provisions during the term of the Support Agreement.

In 2019, Velan led a successful consent solicitation campaign that resulted in the resignation of Progenics Chief Executive Officer Mark Baker and the seating of five new independent directors on the reconstituted seven-member Progenics Board of Directors. Progenics’ reconstituted Board evaluated both companies, the original transaction terms, and Progenics’ prospects as an independent company, and then negotiated, approved and is recommending that Progenics stockholders adopt the Amended Merger Agreement. Two of those five new independent directors, Dr. Gérard Ber and Mr. Heinz Mäusli, will serve on the Board of Directors of the combined company upon the closing of the proposed merger.

"We are very pleased that Velan has agreed to support the Progenics merger and our combined company over the next year," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "As an experienced life sciences investor, Velan sees the potential of our combined company to create a platform that leverages Lantheus’ long-standing expertise in complex manufacturing, supply chain and commercial excellence, with Progenics’ three leading FDA approved products, clinical pipeline and development capabilities."

"We have spent time with Mary Anne and the broader Lantheus team and are pleased with their receptivity to stockholder perspectives, operational excellence, financial prudence, and growth orientation," said Bala Venkataraman of Velan. "We trusted the reconstituted Progenics Board to evaluate the combination with Lantheus. The Progenics Board has spoken, and we applaud its ability to evaluate alternatives and ultimately secure a fair transaction that maximizes long-term value for all stockholders. In particular, we are pleased that the revised deal consideration and improved pro forma governance terms are more closely aligned with the value that Progenics brings to Lantheus. We believe that current market prices do not properly recognize the promising future of the combined company, which involves unique assets, significant synergy benefits, and enhanced leadership. We have spoken with fellow stockholders, both of Progenics and Lantheus, and are pleased to see alignment on the value of the combined company under the revised transaction. We believe this combination is in the best interests of both Lantheus’ and Progenics’ stockholders, as well as patients and physicians. We see significant upside potential from this combination over the long term."

Ann MacDougall, Interim Chairman of the Progenics Board said, "We appreciate the constructive spirit in which Lantheus conducted the negotiations of the Amended Merger Agreement as well as Velan’s support for our efforts and for the transaction."

As previously announced, Progenics and Lantheus have scheduled their respective special meetings of stockholders to vote on matters related to the proposed merger to be held on June 16, 2020. Further details about the time, location and record date for the special meetings will be announced when finalized. The proposed merger is expected to close in the second quarter of 2020, subject to approval by Lantheus and Progenics stockholders and satisfaction of other customary closing conditions.

CYCLACEL ANNOUNCES REVERSE STOCK SPLIT

On April 14, 2020 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that effective at 5:00 p.m., Eastern Time, on April 14, 2020 (the "Effective Time"), the Company will effect a one-for-twenty reverse stock split of its outstanding common stock (Press release, Cyclacel, APR 14, 2020, View Source [SID1234556302]). The reverse stock split, which was unanimously approved by the Company’s Board of Directors, was approved by its stockholders at a Special Meeting of Stockholders held on October 28, 2019. The Company’s common stock will open for trading on The NASDAQ Capital Market on April 15, 2020 on a post-split basis.

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As a result of the reverse stock split, every twenty shares of the Company’s common stock issued and outstanding at the Effective Time will be consolidated into one issued and outstanding share. No fractional shares of common stock will be issued as a result of the reverse stock split; stockholders will be paid cash in lieu of any such fractional shares. Proportional adjustments will be made to Cyclacel’s outstanding warrants and stock options. The Company’s authorized shares and the nominal par value per share of $0.001 will remain unchanged.

In addition, upon the effectiveness of the reverse stock split, the conversion of Cyclacel’s outstanding 6% convertible exchangeable preferred stock and series A convertible preferred stock will be adjusted proportionally and automatically in accordance with the terms of the Company’s Certificate of the Powers, Designations, Preferences and Rights of the 6% Convertible Exchangeable Preferred Stock and Certificate of Designation of Preferences, Rights and Limitations of the Series A Convertible Preferred Stock, respectively.

The reverse stock split is intended to increase the per share trading price of the Company’s common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market. Trading of the Company’s common stock on The NASDAQ Capital Market will continue, on a split-adjusted basis, with the opening of the markets on Wednesday, April 15, 2020, under the existing trading symbol "CYCC" and under a new CUSIP number 23254L603. The reverse stock split reduces the number of shares of the Company’s common stock outstanding from approximately 17.2 million pre-reverse split shares to approximately 860,000 post-reverse split shares.

Information for Stockholders

The Company has retained its transfer agent, American Stock Transfer & Trust Company, LLC ("AST"), to act as its exchange agent for the reverse stock split. AST will provide stockholders of record as of the Effective Time a letter of transmittal providing instructions for the exchange of their stock certificates. Stockholders owning shares via a broker or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to such brokers’ particular processes, and will not be required to take any action in connection with the reverse stock split. For more information regarding the reverse stock split, please refer to the Company’s definitive proxy statement for its most recently held annual meeting of stockholders which can be accessed through Cyclacel’s website at View Source

Median Technologies Reports Full Year 2019 Financial Results

On April 14, 2020 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company, reported its full year 2019 financial results (Press release, MEDIAN Technologies, APR 14, 2020, View Source [SID1234556318]). Median Technologies’ Board of Directors approved the consolidated 2019 financial statements on April 9, 2020.

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As of December 31, 2019, revenue reached €9m, an increase of 41% compared with 2018 revenue of €6.5m. The Company’s quarter-on-quarter revenue growth was steady across 2019, confirming the growth momentum already seen during the second half of 2018. In total, business continued to grow steadily over six quarters, with average quarterly growth of 13.8%. Company revenue was entirely generated by the iCRO business unit, which delivers solutions and services for medical image management in oncology clinical trials. The iBiopsy business unit is not generating revenue at this stage, as it currently only includes Research and Development activities.

As of December 31, 2019, the order backlog for the iCRO business unit stood at €38.3m, an increase of 24.8% compared with the order backlog as of June 30, 2019 and of 61.6% compared with the order backlog as of December 31, 2018.

Selected financial information (IFRS consolidated financial statements)

In 2019, Median’s average headcount was 87 employees, with an acceleration in the pace of recruitment during the second half of 2019: as of December 31, the Company’s headcount stood at 106 employees.

Cash and cash equivalents as of December 31, 2019 were €7.6m, versus €12.7m as of December 31, 2018. Cash expenditure was €0.4m per month for 2019 as a whole. This broke down into €0.8m per month during the first half of the year and €0.3m per month during the second half, excluding the favorable impact of the Research Tax Credit.

Taking these items into account, the Company reported a net loss of €8m, compared with €15.3m in 2018, marking a major decrease of 48%.

2019: stabilization of the iBiopsy technology and record business for the iCRO business unit

iBiopsy: in 2019, Median stepped up its Research and Development activities, with total expenditure of €4.7m, of which a significant share for its imaging phenomics platform iBiopsy. Based on the most advanced AI technology and data science, iBiopsy will, using imaging biomarkers, identify in an innovative manner the specific signatures of certain diseases for their early detection, the quantification of their severity and their monitoring.

During the year, new proprietary extraction solutions for information "hidden" in medical imaging have been developed and optimized in two indications: primary liver cancer (HCC – Hepatocellular Carcinoma), the fourth leading cause of death by cancer worldwide; and hepatic fibrosis in the clinical context of NASH (Non-alcoholic Steatohepatitis), a disease whose prevalence is significantly increasing worldwide. These results were presented during prestigious international conventions and congresses in the United States and Europe.

Median has also developed its technology base and has started to roll out its system on a large scale with a cloud architecture that allows the real-time identification of biomarkers.

A €35m financing agreement with the European Investment Bank (EIB) was signed on December 18, 2019.

Imaging solutions and services for clinical trials (iCRO): 2019 was a record year for the iCRO business unit. The iCRO activity reached breakeven at the end of the first half of 2019 and demonstrated that it is a profitable business with sustainable growth.

In 2019, the iCRO BU continued its growth in China through its WFOE (Wholly Foreign Owned Enterprise) in Shanghai, which has become an operational structure providing local services to biopharmaceutical companies. At end-2019, 56% of the order backlog related to Chinese projects, compared with 39.2% at end-2018.

Median has also largely exceeded its 2019 objectives for Europe and the United States, thanks to a specific and particularly profitable strategy of developing sales based on the recurrence of contracts. This highlights the increased trust in the execution of projects as well as the competitiveness and quality of Median’s services. Across the year as a whole, the quality of services was validated by 12 successful customer audits and one FDA (Food and Drug Administration) audit relating to a major Phase III trial of a Top 3 pharma company.

2020 outlook, excluding the impact of COVID-19

iBiopsy: the 2020 roadmap for iBiopsy will focus on the clinical development plan, product roadmap, clinical and technological strategic partnerships, supported by an intellectual property protection strategy. The first tranche of the loan (€15m of a total €35m) granted by the EIB to Median Technologies will be released before the end of the first half of 2020. In view of this secure financing by the EIB, Median started, as of the beginning of 2020, to step up its investment program and recruitment plan. In 2020, external investments will mainly relate to access to data for clinical approvals on large cohorts and the implementation of the intellectual property protection strategy.

iCRO: the iCRO business should enjoy sustained growth thanks to the conversion of its growing order backlog and its positioning on the Chinese market. The autonomy of Median’s subsidiary in China should continue to increase in 2020. The Company intends to strengthen its iCRO operational teams and sales force across the board.

A review of the COVID-19 situation

In anticipation of the lockdown measures taken by the French government on March 17, 2020 due to the COVID-19 public health crisis, Median instructed all of its French-based employees to work from home as of March 16. The Company’s business continuity has been secured since this date. Median operates globally via cloud-based infrastructures which are used daily to deliver imaging solutions (iCRO) to its customers under normal conditions; services therefore continue to be provided as usual.

iCRO: the start of the public health crisis in China led to delays in February in the reception of images from Chinese hospitals for clinical trials that were already underway. The start dates for new trials in the order backlog were also postponed, leading to a delay to inflows for the Company. The situation was almost entirely back to normal in March.

With the spread of the pandemic in March to Europe and then to the United States, the same impacts have been seen and have generated a delay to inflows since mid-March.

Revenue for the first quarter of 2020 should nonetheless improve compared with the fourth quarter of 2019. A press release announcing 2020 first quarter results will be published shortly. This press release will also provide an overview of the company’s strategy with regard to COVID-19.

Considering the uncertainty surrounding the progression of the public health crisis, it is too soon to provide revenue forecasts for the second quarter. Nevertheless, for 2020 as a whole, Median Technologies expects the impact of the COVID-19 crisis on its iCRO business to be limited.

iBiopsy: research and development activities relating to iBiopsy continue as normal thanks to the development infrastructure that has been in place for several months and which is used on a daily basis under normal conditions. The drawing down of the first tranche of the EIB’s loan shall take place, as initially planned, during the first half of the year.

"The excellent performance of Median’s iCRO business validates the strategic decisions which we made in 2018. We are thrilled to see that this business has become profitable and enjoys sustainable growth. Despite the COVID-19 situation, we expect this momentum to continue in 2020. At the same time, the volume of our order backlog makes us confident in our ability to achieve our 2020 revenue target" said Fredrik Brag, CEO and co-founder of Median Technologies. "In terms of iBiopsy, like the collaboration agreement announced with AP-HP on March 2, we expect 2020 to bring partnerships and clinical data that will enable the large-scale clinical validation of our approach for certain therapeutic indications", Fredrik Brag added.