Stockwinners Market Radar for June 22, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:55 EDT Tellurian names Charif Souki as executive chairman - Tellurian announced that the board has named Charif Souki Executive Chairman of Tellurian. Souki has been Tellurian's non-executive Chairman since founding the company in February 2016.

19:38 EDT Intuit to cut 715 staff, add 700 new roles in 'most strategic areas' - In a company blog post, Intuit CEO Sasan Goodarzi states: "We are now facing a fundamental shift as the pace of change has dramatically increased. More customers are looking for virtual solutions, small businesses are accelerating their shift to omni-channel commerce, and money benefits and offerings matter more than ever... We are playing offense and taking the necessary steps to lead this change... Today, we're announcing a series of changes across the company that will accelerate our transformation and increase our velocity by re-balancing our investments. Regrettably, these changes will impact 715 of our friends and co-workers. To align us for the acceleration we need for the future, we will invest in our most strategic areas, and plan to add more than 700 roles to build the capabilities needed as we look ahead." Reference Link

19:02 EDT Sensient to sell its yogurt fruit preparations product line to Frulact - Sensient announced that it has entered into a definitive agreement to sell certain assets related to the production of its yogurt fruit preparations product line to Frulact. As a result of this transaction, Sensient will be named a core supplier of flavors, colors, and other related products used by Frulact in its fruit preparation business. The transaction is expected to close in Q3 of 2020.

18:34 EDT SPDR Gold Shares s holdings rise to 1,166.04MT from 1,159.31MT - This is the highest level of holdings since April of 2013.

18:24 EDT Penn National CEO: Off to a good start, every day feels a little bit better - In an interview on CNBC's Mad Money, Jay Snowden said most of the company's properties are now open and he expects the pent up demand caused by the COVID-19 pandemic to drive growth. Snowden feels the ability to offer both a brick and mortar and online experience will differentiate Penn from its competitors going forward.

18:10 EDT NYSEG, RG&E file rate case settlement with NYPSC - NYSEG and RG&E, subsidiaries of Avangrid, announced that they have filed a proposed rate case settlement with the New York Public Service Commission. The proposed agreement earned support from stakeholders that include customer groups, industry, governmental and environmental interests, with more than 20 parties signing the settlement. News of the filing comes after months of negotiations and after thoughtful discussions with stakeholders about how the companies can best serve customers in light of the COVID-19 pandemic. "The settlement filed today puts customers first and, upon approval, will provide immediate COVID-19 relief to residential and commercial customers, while also limiting the rate impact to ensure that NYSEG and RG&E customers will continue to have among the lowest electric and gas rates in the state," said Carl A. Taylor, President and CEO of NYSEG and RG&E. "The proposed plan will enable much needed investment in our infrastructure and harnesses the power of technology to make our electric system more resilient, providing for a better customer experience. It also re-affirms our commitment to build more economic, social and environmentally sustainable communities throughout the areas we serve."

17:58 EDT Fiserv director sells 10K shares of common stock - In a regulatory filing, Fiserv disclosed that its Chief Administrative Officer Guy Chiarello sold 10K shares of common stock on June 18th in a total transaction size of $1.04M.

17:43 EDT Spirit Aero says Boeing directed it to reduce 2020 737 production plan - According to a regulatory filing, on June 19, 2020, Spirit AeroSystems (SPR) received a letter from Boeing (BA). Based on the June 19 Letter and further communications between the parties on June 22, 2020, Boeing has directed Spirit to reduce its 2020 B737 production plan from 125 to 72 shipsets, which includes 37 shipsets to be produced and delivered over the balance of the year and 35 shipsets that have already been delivered to Boeing as of June 19, 2020. Boeing indicates in the June 19 Letter that the reduction is due to COVID-19's impact and accumulated inventory of Spirit's B737 products; such inventory was accumulated pursuant to the parties' prior production rate agreements. The B737 MAX grounding coupled with the COVID-19 pandemic is a challenging, dynamic and evolving situation for Spirit. During this time, Spirit plans to work with Boeing to manage the B737 production system and supply chain. Given the substantial production plan reduction, Spirit could breach the financial covenants under its credit agreement in the fourth quarter of 2020 without an amendment or waiver. Spirit is in communication with its lenders regarding this matter, and intends to work with them expeditiously to obtain appropriate relief from its covenants.

17:28 EDT Escalade director Walter Glazer buys over $612K in company shares - Escalade director Walter Glazer disclosed he had purchased 53,633 shares of company stock at $11.42 per share between June 18 and June 22 for a total value of $612,542.

17:21 EDT Grocery Outlet to replace Brinker in S&P 400 at open on 6/25

17:17 EDT Grocery Outlet to replace Brinker in S&P 400 at open 6/25

17:14 EDT Miragen Therapeutics says MRG-229 demonstrates antifibrotic activity in vitro - miRagen Therapeutics announced preclinical safety and efficacy data for MRG-229, a next-generation miR-29 mimic intended for systemic administration and targeted delivery, in Idiopathic Pulmonary Fibrosis, IPF. "MRG-229 has demonstrated mechanistic biomarker regulation and antifibrotic activity in vitro using human model systems. In addition, subcutaneous administration of the product candidate induced the reversal of pathologic fibrotic gene expression and resulted in a significant reduction of fibrosis in the most commonly employed pre-clinical animal model of pulmonary fibrosis. Finally, high doses of MRG-229 in preclinical toxicology studies in rats showed no clinically significant toxicity," stated William S. Marshall, Ph.D., President and Chief Executive Officer of miRagen Therapeutics. "We believe this body of evidence supports further development of MRG-229 as a potentially differentiated approach for the treatment of IPF." "In our recently published analysis of fibrosis progression in the human lung, miR-29 emerged as a key regulator of fibrotic pathways in IPF," said Naftali Kaminski, M.D., Boehringer-Ingelheim Endowed Professor of Internal Medicine, Chief of Pulmonary, Critical Care and Sleep Medicine at Yale School of Medicine, and the principle investigator on NIH-NHLBI CADET grant focusing on mir-29 therapeutics in pulmonary fibrosis. "The most recent data, generated as part of our collaboration with miRagen and supported by an NIH CADET grant, is encouraging and suggests that miR-29 replacement may represent a novel paradigm in the treatment of IPF."

17:02 EDT Canopy Rivers portfolio company receives Health Canada license - Dynaleo, the most recent addition to Canopy Rivers' portfolio of cannabis companies, has received its standard processing license from Health Canada. This follows the completion and commissioning of Dynaleo's 27,000 square foot purpose-built facility, and is a milestone as it aims to ramp up production of white label gummies for the Canadian recreational market. Dynaleo plans to develop and close on its existing customer pipeline that includes licensed producers and traditional consumer packaged goods companies.Canopy Rivers invested in Dynaleo in April 2020. Based on Dynaleo's current ownership, and assuming conversion of Canopy Rivers' convertible debenture and exercise of its warrants, Canopy Rivers' ownership interest in Dynaleo will be approximately 12%.

16:46 EDT Correction: Etsy price target raised to $120 from $88 at Goldman Sachs - Headline originally said "Goldman Sachs price target..." but was meant to say "Etsy price target..."

16:39 EDT T-Mobile commences stock transactions in connection with SoftBank monetization - In a regulatory filing, T-Mobile US (TMUS) announced the commencement of the public securities transactions, subject to market and other factors, in connection with SoftBank's (SFTBF) monetization of a portion of its shareholding in T-Mobile. For every share of common stock sold by T-Mobile in the public securities transactions, T-Mobile has agreed to repurchase one share of common stock from a subsidiary of SoftBank at a price per share equivalent to that received by T-Mobile in its sales. Consequently, the public securities transactions will not involve gain or loss to T-Mobile and will not affect the number of outstanding shares of T-Mobile common stock or T-Mobile's capitalization. T-Mobile announced the commencement of a registered public offering of 133,548,303 shares of its common stock. T-Mobile intends to grant the underwriters of the Public Equity Offering the option to purchase up to an additional 10,016,123 shares of its common stock. T-Mobile announced the expected distribution, on June 26, 2020, on a pro rata basis to the record holders of T-Mobile's common stock as of 5:00 p.m., Eastern Time, on June 25, 2020, of registered, transferable subscription rights to purchase 0.05 shares of its common stock for up to 19,750,000 shares of T-Mobile's common stock. These rights would entitle the holders thereof, other than Deutsche Telekom (DTEGY), SoftBank and Marcelo Claure and their affiliates, to subscribe for T-Mobile's common stock at the per-share price to the public in the Public Equity Offering. As the Record Date is expected to be prior to the closing date of the Public Equity Offering, none of the investors who purchase shares in the Public Equity Offering will receive Rights. The rights are expected to be listed, and trading is expected to commence, on the NASDAQ Global Select Market effective June 24, 2020. In addition, today T-Mobile concurrently announced its intention to sell up to 30,000,000 shares of its common stock to a Delaware statutory trust and the intention of the Trust to offer its cash mandatory exchangeable trust securities in a private offering exempt from registration under the Securities Act. This press release is not an offer to sell or purchase, or a solicitation of an offer to sell or purchase, the Trust Securities.

16:34 EDT Allogene says preclinical findings support DLL3-targeted AlloCAR-T in SCLC - Allogene Therapeutics announced that preclinical findings supporting DLL3-targeted AlloCAR T therapy in small cell lung cancer, or SCLC, and inducible TurboCAR technology were presented in poster sessions at the virtual American Association for Cancer Research annual meeting. In research featured during the virtual meeting, genetically modified T cells expressing chimeric antigen receptors targeting Delta-like ligand 3 were screened, characterized and ranked against targets using in vitro cytotoxicity assays. Highly active DLL3 CARs displaying long-term killing potential were engineered to contain a rituximab off-switch. Lead DLL3 candidates were tested in vivo and robust efficacy was observed in both subcutaneous and systemic models of SCLC. Additionally, while DLL3 RNA has normal tissue expression in the brain, pituitary and testis, toxicity studies using subcutaneous and intracranial tumor models showed no tissue damage in the brain or pituitary. In a second poster, researchers presented data on a version of Allogene's TurboCAR technology that allows cytokine activation signaling to be selectively controlled by a small-molecule on-switch. This iTurboCAR can be activated by a clinically validated dimerizer drug to improve the potency and persistence of CAR T cells.

16:22 EDT Ready At Dawn Studios joining Facebook - In a blog posted by Mike Verdu, VP, AR/VR Content at Facebook, the executive stated: "Ready At Dawn Studios' storytelling and innovation DNA were on full display in Lone Echo and set the standard for VR narrative adventure, showcasing how virtual reality offers players more immersive, memorable, and emotionally charged experiences. Today, I'm excited to share that Ready At Dawn is joining Facebook-and the future of groundbreaking content in VR has never looked brighter. Having shipped titles to multiple platforms in the past, Ready At Dawn is a veteran game developer with some serious chops-as well as a VR pioneer. They've created four titles for the Oculus Platform, including Lone Echo, Echo Arena, Echo Combat, and Lone Echo II, which is currently in development...As part of the Oculus Studios team, Ready At Dawn will continue creating memorable, immersive, and innovative VR content for gamers around the world as an independently-operated studio." Reference Link

16:20 EDT Teligent regains compliance with Nasdaq - Teligent announced that it received notice from Nasdaq indicating that the company has regained compliance with Nasdaq Listing Rule 5450, which requires the company's common stock to maintain a minimum bid price of $1.00 per share. The Nasdaq staff made this determination of compliance after the closing bid price of the company's common stock was at $1.00 per share or greater for the prior 10 consecutive business days.

16:16 EDT Contura Energy idles Kielty Mine due to market conditions - Contura Energy announced strategic actions regarding two of its large properties that will allow the company to further strengthen its financial performance and to rationalize its production in light of market conditions. Today approximately 170 employees of Spartan Mining Company, LLC were notified of the company's intention to idle the Ruby Energy (also known as Kielty) underground mine and the Delbarton Preparation Plant, which is operated by Spartan Mining but owned by Delbarton Mining Company, LLC, each in Mingo County, West Virginia, due to sustained adverse market conditions, which have rendered the mine uneconomic. Additionally, approximately 7 employees of Maxxim Shared Services, LLC working at the facilities were notified of the company's intention to idle the facilities. The Kielty mine produces coal for thermal, industrial, and metallurgical coal markets, and the Delbarton Preparation Plant serves the Kielty mine. In accordance with requirements of the Worker Adjustment and Retraining Notification (WARN) Act, employees were given 60 days' notice of expected layoffs in connection with the idling of these two facilities. Additionally, Contura has decided against constructing a new refuse impoundment at its Cumberland Mine in Greene County, Pennsylvania, and will not spend the significant capital of over $60 million that was previously announced in connection with this project. Instead, Contura has entered into amendments of certain of its coal supply agreements such that all of its obligations to supply coal to customers from the Cumberland Mine will expire as of December 31, 2022. In the meantime, Contura plans to actively market the Cumberland property for sale while it continues to supply coal in accordance with the amended agreements.

16:15 EDT LeMaitre Vascular acquires Artegraft for $90M - LeMaitre Vascular, Inc. announced that it has acquired the business and assets of Artegraft, Inc. for $90M, including $72.5M in cash paid at closing as well as potential earnout payments of $17.5M payable based upon future sales of the acquired business. Under the terms of the deal, LeMaitre will continue to operate Artegraft's manufacturing facility in North Brunswick, NJ for at least three and a half years and will retain most of Artegraft's employees, including seven sales & marketing personnel. Artegraft processes and sells biologic vascular grafts that are derived from bovine carotid arteries and are implanted primarily in hemodialysis access patients. The products are marketed under the brand Artegraft and are sold only in the US. Artegraft generated trade sales of $15.6M and estimated hospital-level sales of $18.6M during the twelve-month period ended May 31, 2020. Artegraft's unit sales grew 10% in 2019. LeMaitre Vascular expects the acquisition to be accretive to profits in the first 12 months following the closing. Further guidance on how this acquisition will affect LeMaitre Vascular's 2020 revenue, operating income and EPS expectations will be provided at the Company's Q2 2020 earnings call in July.

16:09 EDT TEN Ltd announces a one-for-five reverse share split - TEN Ltd announced a one-for-five, 1-for-5, reverse share split of the Company's common shares. The Company's shareholders approved the reverse share split at the Company's annual meeting of shareholders held on May 28, 2020. The reverse share split will take effect, and the Company's common shares will begin trading on a split-adjusted basis on the New York Stock Exchange, as of the opening of trading on or about July 1.

16:07 EDT Apyx Medical approved to sell Helium Plasma products in 5 new countries - Apyx Medical announced that the company has obtained regulatory approval to market and sell its Helium Plasma Technology products in five new countries: Australia, Brazil, Israel, Taiwan and Thailand. The company has contracted with distributors to market and sell its products in each country. "We are very pleased to obtain regulatory approvals to market and sell our Helium Plasma Technology products in these five new countries." said Charlie Goodwin, President and Chief Executive Officer. "We have been focused on pursuing regulatory clearances in international markets as one of our key strategic priorities to enhance Apyx Medical's long-term growth profile. This strategy is based on the prudent expansion of our commercial footprint outside the U.S. by securing the requisite product registrations for our Helium Plasma Technology products, and identifying strong distribution partners in each respective market. While we expect each of these new countries to contribute to our growth profile in the coming years, we are especially excited by the growth opportunity we have in Brazil, which is estimated to be the second largest cosmetic surgery market in the world in terms of both the total number of procedures performed and the number of surgeons. We shipped an initial commercial order to our distributor in Brazil in late-June and we expect to ship our initial commercial orders to each of the other new countries over the second half of 2020."

16:06 EDT Revolution Medicines gives R&D update on novel targeted cancer therapies - Revolution Medicines provided a research and development update regarding the company's innovative portfolio directed against RAS cancers. The R&D update covers the latest developments across certain of the company's programs including: Update on the broad RMC-4630 clinical development program, including new data sets from the ongoing Phase 1 monotherapy clinical trial;New pharmacokinetic profiles and improved tolerability with intermittent dosing schedules;Expanded experience of anti-tumor activity in non-small cell lung cancer patients carrying KRAS mutations; New anti-tumor activity in patients carrying NF1LOF mutations; Recap of recent RMC-4630-related announcements with update on overall program status Highlights of in vivo preclinical data demonstrating induction of anti-tumor immunity via adaptive and innate immunity systems by SHP2 inhibitor monotherapy and combination treatment with a checkpoint inhibitor, as reported in a recent publication by company scientists in Cancer Research New in vivo data on dual targeted therapy with mTORC1-selective inhibitor and KRASG12C inhibitor in preclinical models of resistance to monotherapy; New in vivo data on pharmacokinetic profile and anti-tumor responses to oral administration of novel KRASG12C inhibitor

16:06 EDT Huntsman sees Q2 revenue down approximately 30%-35% y/y, consensus $1.12B - Huntsman reaffirmed its overall general outlook for the second quarter 2020 and announced that overall sales for the quarter are expected to be down between approximately 30%-35% versus last year. Huntsman noted that the sales trends showed improvement from April to May, and it expects to see this continued improvement through June. Results in its Polyurethanes division are expected to be modestly better than expected as trends in China and in U.S. construction, including spray foam, are better than originally anticipated. The better-than-expected results in Polyurethanes are being mostly offset by weaker-than-anticipated results in Huntsman's Textiles Effects division due largely to the prolonged impact of mandated shutdowns in key textile manufacturing regions, and the expected recovery in the industry may not begin until the third quarter due to the continued lockdowns. Huntsman anticipates that adjusted EBITDA in its Textiles Effects division will likely be slightly negative for the second quarter. Huntsman expects that results in the Performance Products division will be in-line with the prior outlook, but the results in the Advanced Materials division may fall a little short of expectations as a result of a deeper trough in Aerospace, Europe, and India than anticipated at the time of its last quarterly earnings call.

16:02 EDT Grainger announces agreement to divest Grainger China - Grainger announced it has entered into a definitive agreement to sell its distribution business in China, Grainger China LLC, to a purchaser owned by the Grainger China management team and Sinovation Ventures, a China-based venture capital firm. This divestiture will better enable Grainger to focus on its key businesses and geographies. To support this portfolio, the company will maintain its Global Sourcing operations based in China. Grainger's Global Sourcing provides the company with private label products in categories that include safety, cleaning, electrical, motors and tools. This transaction is not subject to any financing condition but is subject to the standard regulatory approvals. The deal is expected to close later this year.

15:46 EDT Quanta reports LUMA selection for O&M agreement with PREPA - Quanta Services announced today that LUMA Energy, a joint venture between Quanta Services and Canadian Utilities Limited, an ATCO Ltd. Company, in conjunction with Innovative Emergency Management, has been selected by the Puerto Rico Public-Private Partnership Authority for a 15-year Operation and Maintenance agreement with the Puerto Rico Electric Power Authority, or "PREPA." This O&M agreement engages LUMA to operate, maintain and modernize PREPA's more than 18,000-mile electric transmission and distribution system in Puerto Rico following a transition period, the company said. LUMA's selection by the P3 for the O&M Agreement has received all necessary final regulatory and government approvals and follows a competitive process that lasted for more than a year, Quanta noted. LUMA will not own the T&D assets nor own or operate the power generation assets. Quanta and ATCO each own 50% of LUMA. Duke Austin, Quanta's President and CEO, added, "We believe this opportunity is transformative for Quanta and supports our ongoing strategy of providing sophisticated and valuable solutions to the utility industry that benefit consumers. By bringing together Quanta's industry leading electric utility services and project execution, ATCO's operational excellence and customer service expertise as a utility provider and IEM's unparalleled experience in federal funds management, we have created a purpose-built and effective operator for the Puerto Rico T&D system and the people of Puerto Rico."

14:51 EDT Watanabe sees Arcutis as 'innovation driven company' - Arcutis Biotherapeutics (ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immune-dermatology. In an exclusive interview with The Fly, Arcutis President and CEO Frank Watanabe discussed the company and its focus: "I don't think a lot of people know about our company. We are fairly young, about four years old. I think the most important thing really is that in the last 10 to 15 years, there's been huge consolidation in the dermatology market amongst drug companies that was followed by a big disinvestment in research and development. No one has been developing new drugs that address the kind of problems that doctors, patients and parents have. Arcutis was formed to address that gap, to be an innovation driven company that really focuses on solving the problems that doctors and patients have. I think our pipeline certainly positions us to address a number of those important unmet needs. We think they had a huge opportunity to apply the advances in science to treat dermatologic conditions and not many people have been doing that and that's why we were formed." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.

14:48 EDT Apple CEO Tim Cook says still has Macs with Intel chips in its pipeline - Comment taken from Apple's Special Event livestream.

14:46 EDT Microsoft closes operations side of Mixer, partners with Facebook Gaming - Microsoft's (MSFT) content streaming service Mixer said in a blog post that it has decided to close the operations side of Mixer and help the community transition to a new platform. Mixer added that it is teaming up with Facebook (FB) to enable the Mixer community to transition to Facebook Gaming. This is a key part of a broader effort that Xbox and Facebook Gaming are embarking on, bringing new experiences and opportunities to the entire world of gaming, the company said. "The Facebook Gaming team and Creators will help expand the vision that Mixer has always held around community and building a platform that is inclusive and supportive of each other," Mixer said. "For Mixer's streamers, this opens up the opportunity to reach the vast audience of one of the world's fastest growing streaming platforms. Every month, more than 700 million people play a game, watch a gaming video or interact in a gaming Group on Facebook. For Facebook Gaming's Creators, this brings the ability to partner closely with the Xbox ecosystem, including future opportunities around Xbox Game Pass, Project xCloud and more." The Mixer service will continue to run through July 22, 2020. After that,Mixer.com will redirect to fb.gg, Facebook's desktop home for gaming video, Mixer broadcasting on Xbox One will be temporarily disabled and the Mixer apps will notify or redirect viewers to continue watching their favorite streamers at Facebook Gaming. Reference Link

14:35 EDT Apple says Microsoft 'hard at work' on Office for Mac - Comment taken from Apple's Special Event livestream.

14:34 EDT ViralClear partners with Catalent on potential treatment for COVID-19 - BioSig Technologies and its subsidiary, ViralClear Pharmaceutical sannounced that it has signed an agreement with Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, to work on the development of a potential treatment for adults with advanced Coronavirus Disease 2019 Under the terms of the agreement, Catalent will be developing two oral dosage forms of ViralClear's broad-spectrum anti-viral agent, merimepodib: a solution and a solid oral dosage form. ViralClear is undertaking research to investigate the potential of Merimepodib to fight the SARS-CoV-2 virus, either as a standalone treatment, or in combination with other anti-viral agents or immune modulators. "We are pleased to be working with Catalent that has already manufactured clinical trial materials of our merimepodib oral solution for the current Phase 2 clinical trial and is performing further product development on liquid-filled oral formulations," commented Steve King, Chief Operating Officer of ViralClear. He continued, "ViralClear is committed to using US-based contract development and manufacturing organizations for the development and commercialization of merimepodib."

14:31 EDT Apple introduces macOS Big Sur with Safari browser update - Apple previewed macOS Big Sur, the latest version of the Mac desktop operating system. The company said, "macOS Big Sur introduces a beautiful redesign that is entirely new yet instantly familiar. Safari is packed with new features, including a customizable start page, elegantly designed and more powerful tabs, quick and easy translation, and a new Privacy Report. The updated Messages app lets Mac users send and receive more personal and expressive messages, and easily keep track of and interact within group messages. Maps also offers an all-new experience with immersive features for exploring and navigating the world."

14:22 EDT NJ Governor says casinos may open on July 2, operating at 25% capacity - New Jersey Governor Phil Murphy said in a tweet that casinos in the state may open on Thursday, July 2, operating at 25% capacity. Murphy added that indoor dining may resume at the time, limited at first to 25% capacity. "Additional health and safety guidance will be released within the next several days," the governor tweeted. Publicly traded companies in the space include Boyd Gaming (BYD), Caesars (CZR), Las Vegas Sands (LVS), MGM Resorts (MGM), Penn National (PENN) and Wynn Resorts (WYNN). Reference Link

14:16 EDT Vireo Health sells equity in Pennsylvania Medical Solutions for $37M - Vireo Health International announced that it has reached a definitive agreement with Jushi , a subsidiary of Jushi Holdings, , to divest equity in its subsidiary company, Pennsylvania Medical Solutions, for total consideration $37M. The transaction is subject to regulatory approvals. The transaction's total consideration of $37 million includes $16.3M in cash, $3.8M in the form of a four-year note with an 8% coupon rate payable quarterly and $17M in Right of Use liabilities associated with long-term lease obligations. The transaction also includes an 18-month option for Jushi to purchase equity in another Vireo Health subsidiary, Pennsylvania Dispensary Solution, for an additional $5M in cash.

14:13 EDT Apple introduces iOS 14 - Apple previewed iOS 14, introducing a new update to Home Screen pages with redesigned widgets and the App Library, a new way to tap into the App Store with App Clips, powerful updates to Messages, and more. The company said, "The new widgets present timely information at a glance and can be pinned in different sizes on any Home Screen page. Users can create a Smart Stack of widgets, which uses on-device intelligence to surface the right widget based on time, location, and activity. Home Screen pages can display widgets that are customized for work, travel, sports, entertainment, and other areas of interest. At the end of the Home Screen pages is the App Library, a new space that automatically organizes all of a user's apps into one simple, easy-to-navigate view, and intelligently surfaces apps that may be helpful in the moment. Users can choose how many Home Screen pages to display and easily hide pages for quicker access to the App Library. Incoming FaceTime and phone calls and Siri interactions take on an all-new compact design that enables users to stay in the context of what they are doing. With Picture-in-Picture support, iPhone(R) users can now watch a video or take a FaceTime call while using another app."

14:12 EDT Lyft resolves Americans with Disabilities Act allegations with DOJ - Lyft has agreed to resolve allegations it violated the Americans with Disabilities Act when some of its drivers refused to give rides to people with disabilities who used foldable wheelchairs or walkers, the Department of Justice announced today. The settlement agreement between the United States and Lyft "seeks to ensure that individuals with disabilities who use collapsible mobility devices will have equal access to Lyft rides," the Department of Justice said in a statement. As part of the agreement, Lyft has pledged to revise its wheelchair policies, including notifying new drivers about them, communicate its wheelchair policies once each quarter to current drivers, and create an educational video for drivers, it said. Lyft agreed to refund charges and provide $10 credits to riders who make plausible complaints of discrimination under the company's revised wheelchair policy. Under the settlement agreement, Lyft will pay damages ranging from $4,000 to $30,000 to four complainants with disabilities and a $40,000 civil penalty to the United States. For the next three years, Lyft will provide the Justice Department biannual written reports describing the activities it has taken to comply with the Americans with Disabilities Act. Reference Link

14:04 EDT Live Nation announces 'first ever U.S. drive-in concert series' amid lockdowns - "Live Nation announced their first ever U.S. drive-in concert series - Live From the Drive-In-will bring fans a live music tailgating experience unlike any other, kicking off July 10-12 in Indianapolis, IN, Nashville, TN, and St. Louis, MO. Brad Paisley will headline performances in all three cities, marking the start of a much anticipated return to in person live events. Darius Rucker and Jon Pardi will also headline the series in Nashville and Nelly along with hometown legends El Monstero will headline in St. Louis, while Jon Pardi and local favorites Yacht Rock Revue will headline in Indianapolis. Live Nation is reimagining the live music experience during a time of social distancing by allowing fans to enjoy concerts in a one-of-a-kind drive-in setting from their own private tailgating zones next to their cars. Guests are allowed to bring chairs, food and drinks to party in their zone to personalize their experience. More details including event guidelines can be found at LiveNation.com/DriveIn..."Around the world, we're seeing a real eagerness from our fans and artists to safely get back to the concert experience," said Tom See, President Live Nation Venues - US Concerts. "We are excited to unveil Live From The Drive-In - a completely unique outdoor concert series that will allow fans to enjoy live shows again, while socially distanced. We have an incredible line-up of artists like Brad Paisley, Darius Rucker, Nelly, Jon Pardi and more, who all share our vision to continue to create once-in-a-lifetime moments for fans and are excited to get back to live music through this reimagined experience," the company said in an earlier announcement.

14:00 EDT Chanos says no position in Nikola - Jim Chanos, who has been vocal about his short position in Tesla (TSLA), said while speaking on Bloomberg television that he does not have any position in Nikola (NKLA), which is also developing a battery-powered truck.

13:57 EDT Apple adds features to Apple Watch with watchOS 7 - Apple previewed watchOS 7, delivering enhanced customization tools and new health and fitness features to the smartwatch. The company said, "Personalization is taken to an entirely new level with shareable and discoverable watch face configurations, while sleep tracking, automatic handwashing detection, additional workout types including dance, and a new hearing health feature give greater insight into overall well-being and are designed with privacy in mind. Conveniently on the wrist, Maps is updated with cycling directions and Siri now offers language translation."

13:54 EDT Chanos says 'we are still short Tesla' - Jim Chanos, president and founder of Kynikos Associates, is speaking on Bloomberg television.

13:34 EDT Apple introduces iPad OS 14, featuring optimized app interfaces - Comment taken from Apple's Special Event livestream.

13:27 EDT CEO expects Arcutis to make clinical timelines despite COVID crisis - Arcutis Biotherapeutics (ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immune-dermatology. In an exclusive interview with The Fly, Arcutis President and CEO Frank Watanabe talked about the company's Phase 1/2b study of ARQ-252 in adult patients with chronic hand eczema. Back in April, when Arcutis announced that it had enrolled the first patient, the company said it expected the Phase 2b portion of the study to being in the second half of 2020 and topline data in the second half of 2021. According to the executive: "We haven't made any changes in our guidance since we announced the starting of the trial. We also announced when we released our Q1 results that we've seen obviously some disruption to our clinical trials due to the virus but we certainly haven't seen the magnitude of disruption that I think a lot of other companies have experienced, and we actually indicated when we released our Q1 results that at that time we felt comfortable that we were going to be able to make our previously disclosed clinical timelines. Dermatologists moved almost their entire practice or their entire practice to telemedicine very quickly when the virus first broke out, except for their clinical research programs. Most of our investigators kept doing clinical research and actually doing in person visits for clinical research all the way through the virus. We had some sites that stopped or stopped seeing new patients but most of those sites have come back as well. I think dermatologists don't make that much money doing telemedicine so I think clinical research became an important revenue stream for them and since there weren't regular patients in the office, offices were able to bring in clinical trial subjects one at a time and maintain social distancing guidelines." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. The remainder of this interview to follow.

13:07 EDT Apple introduces iOS 14, featuring updated home screen - Comment taken from Apple's Special Event livestream.

13:00 EDT Arcutis CEO sees 151/154 as potentially preferred in AD, mild-moderate psoriasis

13:00 EDT DERMIS-1, DERMIS-2 data expected in first half of 2021, Arcutis CEO says

13:00 EDT Arcutis CEO says not seeing much COVID-related disruption

12:23 EDT Verizon introduces Verizon Visa Card issued by Synchrony - On June 26, Verizon (VZ) said it will launch the Verizon Visa Card. Verizon's new credit card, issued by Synchrony (SYF), gives consumer wireless customers the ability to save on their monthly Verizon bill through rewards earned on everyday purchases and freedom to use those rewards toward Verizon purchases, including bill payment and the latest 5G phones and accessories. "Visa is proud to partner with Verizon on the introduction of the new Verizon Visa Card," said Kirk Stuart, senior vice president, head of North America Merchant, Visa (V). "As consumers increasingly seek more ways to stay connected digitally, the Verizon Visa Card provides real savings on Verizon's products and services, along with benefits for every day and essential purchases. We look forward to collaborating with Verizon on this exciting new program to deliver value for cardholders and enhance their daily payment experiences."

12:00 EDT CooTek falls -10.5% - CooTek is down -10.5%, or -72c to $6.11.

12:00 EDT DRDGold rises 12.4% - DRDGold is up 12.4%, or $1.57 to $14.22.

12:00 EDT Invitae rises 39.3% - Invitae is up 39.3%, or $7.35 to $26.06.

11:26 EDT Karyopharm announces FDA approval of Xpovio - Karyopharm Therapeutics announced that the FDA has approved oral Xpovio, the company's first-in-class, Selective Inhibitor of Nuclear Export compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication was approved based on response rate under the FDA's Accelerated Approval Program, which was developed to allow for expedited approval of drugs that treat serious conditions and that fill an unmet medical need. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Xpovio will be commercially available immediately in this new indication in the U.S. and Karyopharm will leverage its existing commercial infrastructure to market this second oncology indication. A Marketing Authorization Application for selinexor for relapsed or refractory DLBCL is planned for submission to the European Medicines Agency in 2021.

11:24 EDT Canopy Growth sees $10B market opportunity in U.S. CBD

11:08 EDT One Stop reports 'world's first' PCIe Gen 4 expansion system for A100 PCIe GPUs - One Stop Systems (OSS) announced that it has introduced "the world's first" PCIe Gen 4 expansion system that fully supports Nvidia (NVDA) A100 Tensor Core GPUs, which can boost computing performance up to 20X over the previous generation. "Once again we have delivered unprecedented performance and efficient scalability with the first expansion system that supports the industry's latest and most powerful GPU accelerators. Our solution includes a full stack of AI software and pre-trained AI models that are perfect for AI on the Fly applications, allowing our customers to accelerate workloads at every scale," said David Raun, OSS interim CEO.

11:00 EDT Canopy Growth sees core markets to reach $22B sales by 2023 - Identifies core markets as Canada, U.S. CBD and Germany. Canopy Growth sees "over $60B" in total addressable market opportunity in U.S. upon federal permissibility of cannabis. Canopy Growth sees medium-term sales & marketing expense as mid-teens percentage of sales, see G&A expense as low-double digit percentage of sales and sees R&D expense as mid-single digits percentage of sales. Canopy said it is developing a roadmap to transform its supply chain "into a competitive advantage that enable the commercial strategy." Guidance and comments from investor meeting slides.

10:27 EDT Johnson & Johnson announces 510(k) clearance of new Catalys software - Johnson & Johnson Vision announced the Food and Drug Administration 510(k) clearance of a new software for the Catalys Precision Laser System. The new Catalys cOS 6.0 software with advanced astigmatism management is a collaboration with Cassini Technologies B.V. The new software "simplifies astigmatism management workow and increases operational efficiency," the company said in a statement. Reference Link

10:00 EDT Braemar Hotels & Resorts falls -9.1% - Braemar Hotels & Resorts is down -9.1%, or -30c to $3.01.

10:00 EDT Livent falls -15.6% - Livent is down -15.6%, or -$1.20 to $6.47.

10:00 EDT Tortoise Acquisition rises 23.8% - Tortoise Acquisition is up 23.8%, or $3.34 to $17.38.

09:58 EDT Citron sets $30 price target on Sonos, repeats speculation of Apple M&A appeal - In a recently published report, Andrew Left's Citron Research set a $30 price target on Sonos (SONO). "Sitting at the intersection of stay at home, streaming wars, and the connected home, Sonos has quickly emerged as the leader of sound in the connected home. Yet, it has an enterprise value of just $1 billion today, which is much smaller than many of the SPAC's and stocks du jour of retail traders," the report reads. Calling it "the Apple of Home Audio," Citron argued that "through a suite of products that are flying off shelves," Sonos is "beating" Amazon (AMZN), Google (GOOG) and Apple (AAPL) "at their own game by dominating the connected home speaker category." "Sonos is not a commodity business. Saying that Sonos just sells speakers shows a lack of understanding of the software platform behind the product. With attention to design and quality, Sonos has created a sticky platform. Consider this - existing households represent 37% of new product registrations with the average home carrying 2.9 Sonos products. This means that every new Sonos customer acquired will continue to buy new products over the coming years as they are hooked in the ecosystem... very reminiscent of Apple," it added. Further, Citron highlighted that "Apple has long been speculated as an eventual acquirer of Sonos by multiple firms and the recent trajectory of Sonos' business would make this a better time than ever." In morning trading, shares of Sonos have gained almost 7% to $12.75. Reference Link

09:47 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares falls -7.2% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is down -7.2%, or -$1.51 to $19.60.

09:47 EDT Virgin Galactic rises 13.6% - Virgin Galactic is up 13.6%, or $2.04 to $17.04.

09:47 EDT Tortoise Acquisition rises 20.9% - Tortoise Acquisition is up 20.9%, or $2.94 to $16.98.

09:40 EDT Chicken Soup for the Soul announces 200 hours of programming for Crackle Plus - Chicken Soup for the Soul Entertainment announced up to 200 hours of new original and exclusive programming for Crackle Plus. As one of the only AVODs continually adding original and exclusive programming, Crackle Plus adds the below titles alongside originals and exclusives already available including Crown Vic, The Clearing, On Point, Going From Broke, '85: The Greatest Team in Football History, and Cleanin' Up the Town. As part of Chicken Soup for the Soul Entertainment, Crackle Plus uniquely sources its original content from sister companies Screen Media, a leading content distribution company, and Landmark Studio Group, a producer of premium scripted and unscripted content. Crackle Plus has doubled its content offerings since May 2019 and experienced approximately 40% audience growth since it began to introduce original and exclusive programming in October of 2019. At NewFronts, Crackle Plus will share its plans to develop and produce new and returning original series and feature films as outlined below.

09:38 EDT GDS Holdings announces equity investment by Hillhouse, STT GDC - GDS Holdings Limited announced that two long-term investors, Hillhouse Capital and ST Telemedia Global Data Centres, have agreed to purchase, through a private placement, a total of $505 million of newly issued Class A ordinary shares of the Company at a price equivalent to $65 per ADS. The private placement represents approximately 5.1% of the Company's total outstanding shares. Hillhouse will subscribe $400 million and STT GDC will subscribe $105 million. The purchase price reflects a 5.9% discount to the VWAP of GDS shares for the last 10 trading days ended June 19, 2020. Following the equity investment, Hillhouse's ownership position in GDS will be approximately 3.9% and STT GDC will be approximately 34.2%. The proceeds from the investment will be used by GDS for its organic data center development, potential acquisition opportunities, and other general corporate purposes. The transaction is expected to close in the next few days.

09:36 EDT Disney to begin Disneyland Paris phased reopening on July 15 - Natacha Rafalski, President, Disneyland Paris, announced: "I'm thrilled to share that our iconic Sleeping Beauty Castle will once again welcome guests to its towering spires and sprawling vistas when the resort begins its phased reopening on July 15. Since its temporary closure in March of this year, guests of all ages have been eagerly awaiting the reopening of our premiere European destination. Come July 15, Disneyland Paris will begin a phased reopening with visitors able to return to Disneyland Park, Walt Disney Studios Park, Disney's Newport Bay Club hotel, and Disney Village. We look forward to the return of our cast members and reopening our gates so that our guests may once again enjoy our resort. As we approach this day, we continue to prioritize the health and safety of our cast members and guests. In line with French government and health authorities' recommendations, the phased reopening of Disneyland Paris will present a deliberate approach with enhanced health and safety measures tailored to our specific environment. This will include limits on attendance and require advanced ticketing and reservations to accommodate controlled guest density that aligns with government guidance on physical distancing." Reference Link

09:34 EDT Alkaline Water launches direct to consumer website - The Company announced the launch of its new direct to consumer website Alkaline88.com, where consumers will be able to buy the full line of products, including Alkaline88 waters, A88 Infused favors and eco-friendly aluminum bottles.

09:33 EDT Neoleukin Therapeutics presents preclinical data for NL-201 - Neoleukin Therapeutics announced the presentation of preclinical data on its lead immunotherapy candidate NL-201, an IL-2 and IL-15 agonist, and applications of its de novo protein design platform at the American Association for Cancer Research Virtual Annual Meeting II. NL-201 is a de novo receptor agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit. New data highlights the ability of NL-201 to stimulate and expand CD8+ and NK cells at very low doses with minimal impact on immunosuppressive regulatory T cells. Treatment with NL-201 in animal models was well-tolerated and induced durable, anti-tumor immunity. Additionally, minimal immunogenicity was reported following five weekly doses of NL-201 in non-human primates. Details of the presentations are as follows: Pre-clinical development of NL-201: A de novo alpha-independent IL-2/IL-15 agonist. NL-201 is more potent on CD8 effector cells and NK cells from 10 healthy volunteers than IL-2 and has reduced impact on immunosuppressive Treg cells. This results in a marked increase in relative immune cell activation, especially at low concentrations where IL-2 is often immunosuppressive. NL-201 is well tolerated and promotes durable anti-tumor activity in preclinical models. After two doses of NL-201, 6 of 15 mice bearing CT26 tumors were tumor-free, while all untreated mice, or mice treated with anti-PD-1 or anti-PD-L1 checkpoint inhibitors succumbed to tumor outgrowth. When mice were re-challenged with fresh CT-26 tumor cells, none of the NL-201-treated mice re-grew tumors, demonstrating durable antitumor immunity. NL-201 demonstrates robust single-agent activity in multiple tumor models. NL-201 inhibited tumor growth across a diverse panel of 12 syngeneic murine tumor models. NL-201 shows minimal immunogenicity in non human primates. Five weekly doses of NL-201 led to infrequent, low titer anti-drug antibodies in non-human primates. Overall, 22 of 26 animals had no detectable ADAs; among the four NHPs with low or moderate ADAs, the tolerability and pharmacodynamic activation of lymphocytes appeared to be unaffected after the final dose. All IND-enabling activities remain on track to support a planned IND for NL-201 before the end of 2020. Conditionally active de novo IL-2 cytokine mimetics for targeted immunotherapy: de novo split technology. NEO-2/15 can be divided into two pieces, neither of which bind to the IL-2 receptor subunits.: When combined, the fragments can restore receptor binding activity. If both pieces are fused to antigen-specific binding proteins, IL-2 receptor activation will only occur when the targets for both pieces are present on tumor cells. This split approach to conditional activation results in widening of the therapeutic index in animal models. Split technology, made possible by the designed stability of de novo proteins, offers an opportunity to create next-generation therapeutics with enhanced safety and specificity. Engineered variants of Neo-2/15 potently expand CAR-T cells and promote antitumor activity in lymphoma and solid tumor mouse models. NL-201 robustly expands CAR-T cells and promotes antitumor activity in both solid and lymphoma tumor models. NL-201 promotes CD8:Treg ratio of ~1,000 in the tumor vs. ~20 with IL-2. Targeted delivery of NEO-2/15 to transduced CAR-T cells achieves 100% disease control. NL-201 and targeted variants may be effective at increasing CAR-T cell number and improving outcomes.

09:30 EDT Mersana Therapeutics presents preclinical data on XMT-1592 - Mersana Therapeutics presented preclinical data for XMT-1592, its clinical stage Dolasynthen ADC targeting NaPi2b, as well as progress on its Immunosynthen STING-agonist ADC platform at the American Association for Cancer Research 2020 Virtual Annual Meeting. Poster Title: XMT-1592, a Site-Specific Dolasynthen-Based NaPi2b-Targeted Antibody-Drug Conjugate for the Treatment of Ovarian Cancer and Lung Adenocarcinoma: XMT-1592 is an ADC created using Dolasynthen, Mersana's proprietary, customizable and homogeneous platform designed to precisely optimize an ADC for a given target, drug-to-antibody ratio and antibody. XMT-1592 is currently in an ongoing Phase 1 dose escalation study to determine the maximum tolerated dose in patients with non-small cell lung cancer adenocarcinoma and ovarian cancer. This poster evaluates the benefits of site-specific bioconjugation of Dolasynthen by reporting in vitro and in vivo comparisons of XMT-1592 to a stochastically conjugated version of the ADC. XMT-1592 shows improved in vivo activity, pharmacokinetics and clinical pathology relative to its stochastic counterpart. These data also show that XMT-1592 induced sustained tumor regressions in an NSCLC adenocarcinoma patient-derived xenograft. Poster Title: Systemic Administration of STING-Agonist Antibody-Drug Conjugates Elicit Potent Anti-Tumor Immune Responses with Minimal Induction of Circulating Cytokines These data presented today show that Immunosynthen represents a novel STING-agonist ADC platform for the systemic administration of a therapeutic agent with targeted immune-stimulatory effects. These data show target-dependent anti-tumor immune responses in vitro and in vivo as a single well-tolerated dose for multiple targets in multiple preclinical models. The data also show that the STING-agonist ADC was more active with limited induction of systemic cytokines when compared to intravenously administered unconjugated agonist, suggesting it may confer an improved therapeutic index. In addition, potent ADC-mediated tumor regression led to durable immunological memory in an immune competent model.

09:29 EDT Guardant Health presents data on liquid biopsy - Guardant Health presents new data at the American Association for Cancer Research Virtual Annual Meeting II demonstrating that its LUNAR-2 liquid biopsy is a highly sensitive test that can detect early-stage colorectal cancer. The data presented show that the LUNAR-2 assay achieved 90% sensitivity and 94% specificity in detecting early-stage CRC.1 When restricting analysis of the controls to those who were negative for CRC by colonoscopy, the LUNAR-2 assay demonstrated improved specificity with no reduction in sensitivity. These results are consistent with previously reported data2 showing that the company's multi-modal, cancer-specific circulating tumor DNA technology increases test sensitivity to deliver clinically meaningful results.

09:27 EDT Beyond Air presents preclinical data on nitric oxide - Beyond Air announced in vivo and in vitro data that show the potential efficacy of high concentration nitric oxide in ablation of solid tumors. The data were presented by Dr. Hila Confino of Beyond Air in an e-poster poster titled, "Gaseous Nitric Oxide at High Concentration is a Powerful Anti-Tumor Agent both in-vitro and in-vivo" at the American Association for Cancer Research Virtual Annual Meeting II. Three studies were conducted to characterize the anti-tumor effects of gNO in vivo. In the first study, subcutaneous colon cancer tumors were treated locally with high-dose gNO delivered by intratumoral injection or direct external exposure. Tumor ablation was successful in five of 30 mice. In the second study, gNO was used to ablate primary tumors in tumor-bearing mice. The NO-treated tumor-bearing mice were later inoculated with a second challenge of tumor cells. All gNO-treated tumor-bearing mice rejected the second tumor cell inoculation. In contrast, tumor take was 100% following tumor cell inoculation in naive mice serving as controls. These data suggest that an anti-tumor immune response was triggered by gNO ablation of the primary tumor. In the third study, splenocytes extracted from an NO-treated tumor-bearing mouse were mixed with mouse colon cancer cells and inoculated to naive mice. The splenocytes dose-dependently inhibited the growth of tumors in the naive mice, supporting an immune-mediated anti-tumor effect of gNO.

09:24 EDT Medtronic Evolut TAVI system receives expanded indication in Europe - Medtronic announced CE mark and European launch of the Evolut Transcatheter Aortic Valve Implantation system for patients with severe native aortic stenosis who are at a low risk of surgical mortality. The low-risk patient population is the final surgical risk category to be approved for this minimally invasive alternative to open-heart surgical valve replacement and includes patients who may be younger1 and more active than higher-risk patients. The Evolut TAVI platform also received a new indication approval that allows for the treatment of patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality. The expanded low-risk indication approval is based on clinical data from the global, prospective, randomized, multi-center Evolut Low Risk Trial, which evaluated three valve generationsagainst SAVR in more than 1,400 patients. The data showed TAVI to have an excellent safety profile and be an effective treatment option in low-risk patients with shorter hospitals stays and improved 30-day quality-of-life scores compared to SAVR. In addition to a lower rate of the composite of all-cause death or disabling stroke with TAVI at 30 days, the Evolut system demonstrated superior hemodynamic performance with significantly lower mean aortic valve gradients and larger EOAs compared to surgery at one year - factors that may be important for more active patients. The rate of new pacemaker implantation and residual aortic regurgitation was higher in the TAVI group.

09:22 EDT Delta to resume flights between U.S. and China on June 25 - Delta Air Lines announced that it will re-start service between Seattle and Shanghai-Pudong via Seoul-Incheon on June 25, operating twice per week. From July and beyond, it will operate once-weekly flights from Seattle and Detroit, also via Incheon. "Delta is the first U.S. airline to re-connect the U.S. and China since the temporary suspension in February due to the outbreak of COVID-19," the company said in a post to its news hub website. Reference Link

09:21 EDT Tonix Pharmaceuticals announces results from preclinical study of TNX-1700 - Tonix Pharmaceuticals announced that preclinical results of TNX-1700 are being presented in a poster at the American Association of Cancer Research Virtual Annual Meeting II. The meeting is being held online June 22-24, 2020. The poster can be found on the Scientific Presentations page of Tonix's website. A poster, titled "Stabilized recombinant trefoil factor 2 enhances anti-tumor activity of PD-1 blockade in mouse models of colorectal cancer," includes data from a preclinical study which investigated the role of PD-L1 in colorectal tumorigenesis and evaluated the utility of targeting myeloid-derived suppressor cells in combination with PD-1 blockade in mouse models of colorectal cancer. The data show that anti-PD-1 monotherapy was unable to evoke anti-tumor immunity in this model of colorectal cancer, but TFF2-CTP augmented the efficacy of anti-PD-1 therapy. Anti-PD-1 in combination with TFF2-CTP showed greater anti-tumor activity in PD-L1-overexpressing mice. Tonix is developing TNX-1700 (rTFF2-CTP) for the treatment of gastric, colon and pancreatic cancers under a license from Columbia University. The studies conducted were performed by scientists at Columbia University under the direction of Timothy Wang, M.D., Chief of the Division of Digestive and Liver Diseases at Columbia University Irving Medical Center.

09:18 EDT TG Therapeutics announces preclinical data for TG-1701 - TG Therapeutics announced preclinical data presentation for TG-1701, the Company's highly selective, BTK inhibitor, at the 2020 American Association for Cancer Research annual meeting, being held virtually. Title: TG-1701, a novel irreversible Bruton's kinase inhibitor, does not inhibit anti-CD20-driven ADCC and ADCP in vitro, and cooperates with the glycoengineered anti-CD20 mAb, ublituximab, in in vivo mantle cell lymphoma models: In vitro and in vivo studies were undertaken to evaluate the activity of TG-1701 alone and in combination with ublituximab and umbralisib in models of lymphoma: TG-1701 showed greater selectivity for BTK than, and similar activity to, ibrutinib in mantel cell lymphoma models; TG-1701, in contrast to ibrutinib, did not block ublituximab-driven antibody-dependent cellular cytotoxicity or antibody-dependent cell phagocytosis in vitro; In vivo xenograft studies suggested that TG-1701 synergized with the U2 combination, resulting in greater anti-tumor activity than either TG-1701 or U2 alone.

09:16 EDT Turning Point Therapeutics presents preclinical data on repotrectinib - The preclinical antitumor activities of repotrectinib in combination with proxy molecules for AMG510, an investigational KRAS-G12C inhibitor, and trametinib, an approved MEK inhibitor were highlighted for the first time in two poster presentations. The studies show repotrectinib's inhibition of SRC, FAK and JAK2 at therapeutically relevant concentrations, which in combination with AMG510 or trametinib demonstrated a synergistic effect over the single agent by reducing tumor cell growth and enhancing tumor cell death. The repotrectinib-trametinib combination studies were replicated across panels of KRAS mutant non-small cell lung, colorectal and pancreatic cancer cell lines that harbor a spectrum of KRAS mutations. The frequently mutated Kirsten Rat Sarcoma viral oncogene is associated with a broad range of human cancers, including approximately 25 percent of non-small cell lung, 45 percent of colorectal and 75 percent of pancreatic cancers. Therapeutic targeting of KRAS has proven challenging, in part due to resistance and adaptive upregulation of alternative signaling pathways that promote tumor cell survival, as well as concurrent secretion of various cytokines and growth factors. In preclinical models, repotrectinib inhibits SRC and FAK signaling, a key pathway for oncogenic resistance, and JAK2, a driver of cytokine secretion pathways. TPX-0131 has been internally designed with a compact macrocyclic structure to bind completely within the ATP binding site of ALK. In preclinical studies, TPX-0131 potently inhibits wildtype ALK and numerous ALK mutations, in particular the clinically observed G1202R solvent-front mutation and G1202R/L1196M compound mutation. In cell proliferation assays presented at AACR, TPX-0131 exhibited greater potency against wildtype ALK as compared to proxy molecules for approved front-line ALK inhibitors crizotinib, alectinib, brigatinib and ceritinib, and comparable potency to a proxy molecule for approved ALK inhibitor, lorlatinib. TPX-0131 demonstrated more than 100-fold greater potency against the G1202R solvent-front mutation as compared to proxy molecules for the approved ALK inhibitors. Additionally, TPX-0131 is the most potent inhibitor against a range of EML4-ALK compound mutations while prior generation ALK inhibitors tested have shown moderate to no activity. Anaplastic lymphoma kinase- driven tumors are estimated to represent up to 7 percent of driver oncogenes in non-small cell lung cancer and in one study of patients who develop a resistance mutation, G1202R was reported in approximately 42 percent of patients, and compound mutations have been reported in approximately 35 percent of patients who developed resistance following treatment with lorlatinib.

09:13 EDT Natera expands laboratory facility in Austin, Texas - Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, is pleased to announce the expansion of its laboratory facility in Austin, Texas, supporting greater test processing capacity. This newly expanded, 70,000 square foot facility provides significant additional lab capacity and adds cutting-edge, automated lab equipment and capabilities. In addition, the facility will allow for lower COGS, increase access to an expanded labor pool, and extend Natera's operational continuity plans.

09:12 EDT CytomX announces preclinical data from Anti-CTLA-4 probody therapeutic programs - CytomX Therapeutics (CMTX) announced that its partner Bristol Myers Squibb (BMY) presented preclinical data from BMS-986249 and BMS-986288, anti-CTLA-4 Probody therapeutics generated with CytomX's novel Probody technology platform. The electronic poster #4551 titled "Preclinical characterization of novel anti-CTLA-4 prodrug antibodies with an enhanced therapeutic index" was presented as part of the Therapeutic Antibodies 3 Session at the American Association of Cancer Research's 2020 Virtual Annual Meeting II. BMS-986249 is a Probody version of the anti-CTLA-4 antibody ipilimumab. In February 2020, Bristol Myers Squibb treated the first patient in a Part 2a randomized cohort expansion in an ongoing Phase 1/2a trial of BMS-986249 in combination with Opdivo in patients with metastatic melanoma. Additional information is available at ClinicalTrials.gov using the Identifier NCT03369223. BMS-986288 is a Probody of a nonfucosylated version of ipilimumab. In September 2019, Bristol Myers Squibb initiated the dose escalation phase of a Phase 1/2a clinical trial of BMS-986288 administered as monotherapy and in combination with nivolumab in patients with selected advanced solid tumors. Additional information is available at ClinicalTrials.gov using the Identifier NCT03994601. These Probody programs, designed to optimize the therapeutic index of CTLA-4-directed therapy, arose from the companies' 2014 worldwide oncology license and collaboration agreement.

09:08 EDT BeiGene, SpringsWorks present preclincal data on lifirafenib with mirdametinib - BeiGene (BGNE) and SpringWorks Therapeutics (SWTX) announced the presentation of preclinical data and provided a program update on their ongoing Phase 1b/2 study evaluating the combination of BeiGene's investigational RAF dimer inhibitor, lifirafenib, with SpringWorks' investigational MEK inhibitor, mirdametinib, in patients with advanced or refractory solid tumors harboring mutations in the MAPK pathway, including those with RAS mutations. The preclinical data were presented in a poster at the American Association for Cancer Research 2020 Virtual Annual Meeting II by researchers from BeiGene, SpringWorks, and Memorial Sloan Kettering Cancer Center. Among the findings presented, lifirafenib and mirdametinib demonstrated potent and synergistic activity in vitro and in vivo across a panel of RAS-mutated cancer models harboring a variety of mutations using clinically relevant concentrations of the compounds. Furthermore, in KRAS Q61K and KRAS G12C xenograft models, the combination demonstrated synergy as validated by pharmacodynamic pathway inhibition and tumor regressions. These preclinical findings provided further support for the ongoing Phase 1b/2 combination study of lifirafenib and mirdametinib, which is evaluating this "vertical inhibition" strategy for treating patients whose cancers harbor RAS mutations and other MAPK pathway aberrations. Based on the progress of the program and the clinical data observed to date, the companies reiterated their previous guidance to complete the dose escalation portion of the trial by the end of 2020 and to commence dose expansion cohorts in tumor types of interest thereafter, including KRAS-mutated non-small cell lung cancer and KRAS-mutated endometrial cancer. Initial clinical data from the trial is expected to be presented at a medical conference in 2021.

09:06 EDT MediGene presents data from preclinival studies on PD1-41BB switch receptor - Medigene presents insights from preclinical studies on its PD1-41BB switch receptor at the 2020 American Association for Cancer Research Virtual Annual Meeting II taking place from 22 - 24 June 2020. Medigene's scientists demonstrated that the PD1-41BB switch receptor significantly improves the functional activity of T cell receptor-modified T cells especially against solid tumor cells. Many solid tumors create a "hostile" microenvironment that suppresses immune cell attack, enabling tumors to survive and grow. To this end, tumor cells employ so-called "checkpoint mechanisms" to impede T cell activity. One prominent inhibitory axis exploited by tumors, the PD1-PDL1 pathway, is known to shut down T cell activity in tumors. Medigene's PD1-41BB molecule is designed to convert the PD-1 "stop" signal induced by tumor cells to a "go" command by switching signals inside the T cells to activation, thereby overcoming the PD1-PDL1 inhibitory checkpoint blockade.

09:06 EDT NCR Corp. appoints Timothy Oliver as CFO - NCR Corporation announced Timothy Oliver is joining the company as its new CFO effective July 13. NCR said in a release, "Oliver brings 30 years of financial management experience to NCR. As President & Chief Financial Officer of the Goldstein Group, a private conglomerate comprised of several operating companies and a passive investment portfolio, and Alter Trading, the largest of its operating companies, Oliver was responsible for the company's overall financial strategy and updated operations by realigning the reporting structure, implementing and operationalizing new IT tools as part of a broader ERP project and relaunching lender relations efforts to improve transparency."

09:05 EDT Flushing Financial receives grant money from FHLBNY grant program - Flushing Financial Corporation announced that the Bank has received funds from the FHLBNY Small Business Recovery Grant Program. These funds are intended to support the financial security and health of workers employed by organizations that have suffered a decrease in revenue as a result of the ongoing COVID-19 crisis. The Bank has begun to disburse the grant money to local small businesses and non-profit organizations in their market area.

09:04 EDT Genocea presents preclinical data on inhibigen biology - Genocea Biosciences presented preclinical data that offers new and important insights into the biology and behavior of inhibitory neoantigens at the American Association for Cancer Research Virtual Annual Meeting II from June 22-24. The findings build on previous research presented at SITC 2019 which demonstrated that the presence of an Inhibigen in an otherwise protective immunotherapy can completely reverse anti-tumor responses. In the preclinical study, pro-tumor Inhibigen effects were found to be correlated with an increasingly immune-suppressive tumor microenvironment, including reduced TILs and enhanced expression of T cell exhaustion markers. Vaccination of tumor-bearing mice with a formulation containing an inhibigen impaired both tumor antigen specific and nonspecific T cell function by blocking their ability to secrete cytokines and kill tumor cells - an effect that abolished T cell responses to beneficial anti-tumor antigens. In addition, the poster presentation revealed that immunization with Inhibigens led to a reduction in T cell receptor expression of tumor-specific T cells, which further hindered T cell function and activity needed to produce a robust immune response. The analysis also demonstrated that the Inhibigen-specific responses are not mediated by regulatory T cells - a subset of T cells known to suppress immune responses.

09:02 EDT Carnival extends operational pause in North America through September 30 - Carnival Cruise Line advised guests and travel agents that it has extended its operational pause in North America through September 30. "During this unprecedented pause in our business, we have continued to assess the operating environment and confer with public health, government and industry officials," Carnival Cruise Line President Christine Duffy told booked guests and travel agents in a letter sent today. But she added that following the cruise industry's announcement on Friday that it would voluntarily extend its pause in North America, Carnival Cruise Line is now cancelling all cruises through September 30. "We have watched with great interest as commerce, travel and personal activities have begun to start back up, and once we do resume service, we will take all necessary steps to ensure the health and safety of our guests, crew and the communities we bring our ships to in order to maintain public confidence in our business. Nevertheless, we apologize for disrupting your vacation plans and appreciate your patience as we work through these decisions," Duffy said in the letter. Carnival initially announced a voluntary 30-day pause in operations on March 13, and has now extended that pause three times, reflecting the public health challenges associated with the COVID-19 pandemic. It is currently completing the repatriation of nearly 29,000 crew members to more than 100 nations who serve its fleet of 27 ships. As with previous pause announcements, Carnival is giving guests who wish to move their booking to a later date a rebooking offer that combines a Future Cruise Credit and either a $300 or $600 Onboard Credit that has proven very popular with their guests. Guests, as always, have the option to receive a full refund. The process is fully automated so that guests can submit their preference online and they have until May 31, 2021 to make a selection.

08:56 EDT Contango Oil & Gas reports Q1 production of 1,720 Mboe

08:52 EDT LiveXLive Media to produce pay-per-view event with Monsta X - LiveXLive Media announced it will produce an international pay-per-view event with global K-Pop sensation Monsta X. In collaboration with Starship Entertainment, LiveXLive will exclusively live stream the band's only full-length global performance scheduled for 2020. The event is scheduled for Saturday, July 25 at 8 p.m. PT / 11 p.m. ET / Sunday, July 26 at 12 p.m. KT. Ticket sales will kick off on June 26.

08:50 EDT FuelCell resumes manufacturing at Torrington facility - FuelCell Energy announced that it has resumed manufacturing at its Torrington, CT facility. The Company previously announced that it had temporarily suspended manufacturing activities on March 18, 2020 in light of the COVID-19 outbreak as a proactive and voluntary measure to secure the safety of the Company's employees and the communities in which our employees live. All team members affected by the temporary shutdown have remained employed by the Company and have received full pay and benefits for the duration of the temporary shutdown. By implementing work from home practices and continuing limited laboratory activity and fuel cell platform construction and operations services, the Company was able to continue its research and development work regarding the Company's carbon capture solution under our joint development agreement with ExxonMobil Research and Engineering, the development of our advanced solid oxide electrolysis, hydrogen storage, and hydrogen power generation under our US Department of Energy cooperative agreements, construction of our project backlog, and routine fuel cell platform service and operations. During this time, progress was also made on construction of the 7.4 megawatt fuel cell project located on the U.S. Navy Submarine Base in Groton, CT, and on-site construction of the 1.4 megawatt fuel cell platform in San Bernardino, California commenced. The Company has self-certified with the State of Connecticut Department of Economic and Community Development its commitment to compliance with all applicable sector guidelines.

08:48 EDT Precigen presents preclinical data for PRGN-3005 UltraCAR-T - Precigen announced preclinical data for its innovative investigational PRGN-3005 UltraCAR-T in patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer has been published as an e-poster and accompanying audio presentation at the American Association for Cancer Research Virtual Annual Meeting II. Preclinical data demonstrate the specificity and efficacy of using the rapidly manufactured PRGN-3005 UltraCAR-T cells for the treatment of ovarian tumors. Specifically, a single administration of PRGN-3005 showed significantly superior expansion and preferred memory phenotype of UltraCAR-T in vivo and significantly superior efficacy compared to traditional CAR-T resulting in all PRGN-3005 treated mice becoming tumor-free. Furthermore, rechallenging these tumor-free mice three months later with ovarian tumors for a second time (to simulate tumor relapse) led to the elimination of tumor burden without additional PRGN-3005 UltraCAR-T treatment. These data demonstrate the potential of UltraCAR-T cells to persist long-term in vivo, prevent CAR-T cell exhaustion, and mount a durable anti-tumor response with the ability to continue to respond upon tumor rechallenge. "We are pleased to be able to share the preclinical data for PRGN-3005 that led to the IND clearance and initiation of the Phase I study," said Helen Sabzevari, PhD, President and CEO of Precigen. "Our preclinical results demonstrate that PRGN-3005 UltraCAR-T administered one day after non-viral gene transfer has superior anti-tumor efficacy and persistence compared to traditional CAR-T cells and represents a promising opportunity for ovarian cancer treatment. We look forward to sharing the first clinical data for PRGN-3005 in the second half of 2020."

08:45 EDT Allogene Therapeutics announces publication highlighting ALLO-819 potential - Allogene Therapeutics announced a publication in Molecular Therapy demonstrating the potential for ALLO-819, an investigational AlloCAR T therapy targeting FLT3 as a novel treatment for acute myeloid leukemia. These preclinical findings were previously presented as a poster at the 61st American Society of Hematology Annual Meeting & Exposition in December 2019. In this study, healthy donor T lymphocytes were engineered to express CARs that bound to different domains of the FLT3 protein. These CARs were then tested for their ability to mediate specific killing of FLT3-expressing cells without off-target activity. A CAR construct was selected based on exhibiting minimal potential for exhaustion and potent antitumor activity in vitro and in vivo models.The lead candidate was then engineered to contain an off-switch responsive to rituximab, resulting in ALLO-819.

08:44 EDT PDS Biotechnology announces publication of results of PDS0101 combination - PDS Biotechnology announced the publication of data generated by the National Cancer Institute based on preclinical studies of PDS Biotech's lead clinical program, PDS0101, in combination with two other investigational anti-cancer agents. The article "Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine" by Rumfield et al. was published in the Journal for ImmunoTherapy of Cancer, and provides strong rationale for clinical evaluation of this three-component treatment combination in a recently initiated NCI-led Phase 2 clinical trial. The results of the NCI's preclinical study indicated that PDS0101 generated both human papillomavirus-specific T-cells and an associated antitumor response when used as a monotherapy. When PDS0101 was combined with two other development-stage anti-cancer agents, Bintrafusp alfa and NHS-IL12, the data suggest the agents worked synergistically to provide enhanced tumor regression and T-cell response as compared to the agents alone. The studies detailed in the Journal for ImmunoTherapy of Cancer were conducted under an existing Cooperative Research and Development Agreement between PDS Biotech and the NCI. The CRADA includes collaborative development work on both PDS0101 and a second development stage compound, PDS0103.

08:43 EDT Marrone Bio regains compliance with Nasdaq requirement - Marrone Bio Innovations announced that it received notice from The Nasdaq Stock Market on June 19, 2020 indicating that the Company has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market.

08:41 EDT MicroVision regains Nasda1 compliance - MicroVision announced that it has received a letter from Nasdaq confirming that it has regained compliance with Nasdaq's listing requirements. As previously announced, MicroVision was notified on June 13, 2019, that it had failed to meet the minimum bid price requirement under Nasdaq Stock Market Listing Bid Price Rule 5450(a)(1). In February, the Company was notified that the Nasdaq Hearings Panel had granted the company an extension of time to regain compliance. In April, in response to the COVID-19 pandemic, Nasdaq announced temporary relief from the continued listing bid price requirement through June 30, 2020 extending the time Company had to regain compliance before August 24, 2020. MicroVision was notified by Nasdaq that it is now in compliance with the rule and that Nasdaq considers the matter closed. The company's shares will continue to be traded on The Nasdaq Global Market under the symbol MVIS.

08:39 EDT Corbus Pharmaceuticals reports last subject visit in Phase 2b study of lenabasum - Corbus Pharmaceuticals Holdings announced that the last subject completed their final visit in the Company's Phase 2b JBT101-CF-002 trial of lenabasum for the treatment of cystic fibrosis. Topline results from the study are on track to readout in the third quarter of 2020, following the topline data from the RESOLVE-1 Phase 3 systemic sclerosis study. The Phase 2b trial is a multinational, 426-subject study evaluating the efficacy and safety of lenabasum in cystic fibrosis. This is a double-blind, randomized, placebo-controlled study, with dosing of lenabasum at 5 mg twice per day, lenabasum 20 mg twice per day or placebo twice per day for 28 weeks, with 4 weeks safety follow-up off active treatment. The primary efficacy endpoint is the event rate of pulmonary exacerbation. Secondary efficacy outcomes include other measures of PEx, change in forced expiratory volume in 1 second, % predicted, and change in Cystic Fibrosis Questionnaire-Revised respiratory domain score. The Phase 2b CF study is funded in part by a Development Award for up to $25 Million from the Cystic Fibrosis Foundation. Lenabasum has been granted Orphan Drug designation and Fast Track designation for the treatment of cystic fibrosis by the U.S. Food and Drug Administration and Orphan Designation for the treatment of cystic fibrosis from the European Medicines Agency.

08:37 EDT 21Vianet announces $150M investment from Blackstone - 21Vianet Group (VNET) announced that funds managed by Blackstone (BX) have agreed to make a $150 million investment in the Company. As a result of this investment, Blackstone will become one of the Company's largest institutional stockholders. The transaction is subject to the satisfaction of customary closing conditions. This investment will further strengthen the balance sheet of 21Vianet and help support the rapid growth that 21Vianet is experiencing in wholesale and enterprise data center markets. 21Vianet intends to use the proceeds from the private placement on capital expenditures to reinforce its position in China's hyper growth data center market. The Blackstone investment in 21Vianet includes the following material terms: The investors will subscribe $150 million newly issued Series A perpetual preferred shares. The Preferred Shares are convertible into American Depositary Shares of the Company at a conversion price of $17.00 per ADS, or into Class A ordinary shares of the Company at a corresponding conversion price. The conversion price represents a premium of 11% to the volume-weighted average price of ADSs for the 30 trading days immediately preceding the signing date, subject to customary anti-dilution adjustments. The Preferred Shares are not redeemable. The Preferred Shares will bear dividend at a rate of 4.5% per annum and rank senior to the Company's ordinary shares in liquidation. 21Vianet will have the right to trigger a mandatory conversion at its election, if its ADSs achieve a specified price threshold at 200% of the conversion price for a specified period. As part of the transaction, Blackstone will designate a non-voting observer to attend meetings of the 21Vianet Board of Directors, subject to maintaining its shareholding at or above a specified percentage threshold.

08:36 EDT Inpixon enters license agreement for Systat, SigmaPlot software suite - Inpixon announced it has entered into an exclusive global license agreement to develop, market and distribute the Systat and SigmaPlot software suite of products. Systat and SigmaPlot are data analytics and statistical visualization solutions and are estimated to have more than 400,000 users across 37 countries. The transaction is expected to be accretive to earnings and will expand Inpixon's subsidiary operations into the United Kingdom and Germany. The transaction is expected to close in the coming weeks, subject to closing conditions.

08:34 EDT Barrick Gold begins drilling on Loncor JV ground in DRC - Loncor Resources announces that Barrick Gold SARL has commenced its core drilling program on several priority gold targets within the Ngayu greenstone belt in the northeast of the Democratic Republic of the Congo. The beginning of the drilling campaign signals a significant step in the sequence of events necessary to assess numerous areas of potential. Since entering the JV agreement with Loncor in January 2016, Barrick has conducted various exploratory programs to define drill targets, targets that offer the early potential of attaining "Tier 1" status. The drilling on the Anguluku prospect is targeting a folded and thrust sequence of mineralised banded ironstone formation. Further drilling is planned to be undertaken by Barrick at the other priority targets of Medere, Makasi, Lybie, Salisa and Bakpau NE in the Imva area in the west of the Ngayu belt. Outside of the Barrick joint venture, exploration activities by Loncor continued on Loncor's Imbo Project in the east of the Ngayu belt. The Imbo Project contains 2.5 million ounces of inferred mineral resource, which includes the 2.19 million ounce inferred mineral resource of the Adumbi deposit, with 76.29% of this resource being attributable to Loncor via its 76.29% interest in the Imbo Project. Fieldwork by Loncor geologists have been focusing on the Imbo East prospect 12 kilometres southwest of the Adumbi deposit, along the same mineralised structural trend. Gridding, soil and rock sampling are being undertaken over a strike length of 3.6 kilometres at Imbo East. In addition, two new targets have been generated. Both these target areas were identified from the compilation and interpretation of previous, historical exploration data including soil geochemistry, rock chip and channel sampling. At Mambo Bado, 1.5 kilometres northwest of the Adumbi deposit, a prominent geochemical gold in soil anomaly is located on an extensional, E-W structural jog along the 14-kilometre northwest trending mineralised shear zone within the Imbo permit area. No drilling has been undertaken previously on this promising target. Two kilometres south of the Adumbi deposit, at Lisala, altered and brecciated BIF with anomalous rock sampling requires further follow up with gridding, soil sampling and additional channel sampling.

08:34 EDT Jones Lang LaSalle names Karen Brennan as CFO, succeeding Stephanie Plaines - Jones Lang LaSalle announced the appointment of Karen Brennan as CFO, effective July 15. Brennan, currently the CEO of LaSalle's operations in Europe, will report to CEO Christian Ulbrich and will join JLL's Global Executive Board. She succeeds Stephanie Plaines, who has decided to leave JLL for personal reasons after a transition period. During her more than 20 years with LaSalle, Brennan developed extensive experience across the global commercial real estate sector while based in Chicago and Baltimore in the United States, Singapore, Hong Kong and London. As CEO for LaSalle Europe, she had overall responsibility for business strategy across six offices managing approximately $22B in assets under management.

08:32 EDT Ziopharm completes enrollment of Phase 2 trial of IL-12 with Libtayo - Ziopharm Oncology (ZIOP) announced that 36 subjects have been enrolled in the phase 2 clinical trial evaluating Ad-RTS-hIL-12 with veledimex in combination with the PD-1 inhibitor Libtayo for the treatment of recurrent or progressive glioblastoma in adults. Subjects in this multi-center trial were enrolled from seven hospitals specializing in the treatment of brain cancers across the United States. Ziopharm's Controlled IL-12 platform is an investigational gene therapy designed to induce and control the production of human interleukin 12, a master-regulator of the immune system. In the setting of rGBM, the Company is leveraging the anti-tumor effects for Controlled IL-12 as a monotherapy and in combination with PD-1 inhibitors. Clinical data supporting the combination of Controlled IL-12 and a PD-1 inhibitor were initially published in Science Translational Medicine. Data from serial biopsies in patients with rGBM revealed that Controlled IL-12 results in the sustained influx of activated T cells and upregulation of PD-1 expression, providing a compelling rationale for this combination. Recently, additional data from a phase 1 trial were presented at the American Society of Clinical Oncology 2020 virtual meeting showing Controlled IL-12 in combination with a PD-1 inhibitor had a favorable safety profile and preliminary signs of anti-tumor efficacy. The open-label, single-arm phase 2 trial is designed to examine Controlled IL-12 in combination with cemiplimab in 36 patients with rGBM, with the primary endpoints being safety and efficacy. Patients with rGBM scheduled for resection, who have not been treated previously with immune checkpoint inhibitors, received Ad-RTS-hIL-12 intratumorally at the time of surgical resection plus 20 mg of veledimex, an oral activator of Ad-RTS-hIL-12, daily for 14 days. Patients will also receive cemiplimab intravenously every three weeks until documented progression or withdrawal from the study. Trial investigators may enroll additional patients currently in screening. In November 2018, Ziopharm and Regeneron entered a clinical supply agreement to evaluate combination therapy of Ziopharm's Controlled IL-12 with Regeneron's (REGN) PD-1 antibody cemiplimab to treat patients with rGBM.

08:30 EDT aTyr Pharma presents preclinical research on NRP2 antibody effects - aTyr Pharma announced a poster and audio presentation at the 2020 American Association for Cancer Research Virtual Annual Meeting II, which is being held June 22 - 24, 2020. The poster is available for browsing on the AACR website from June 22 - 24, 2020. The poster presents findings from a preclinical study, conducted in collaboration with Dr. Arthur M. Mercurio and his lab at the University of Massachusetts Medical School, demonstrating that aTyr has generated a panel of anti-human NRP2 monoclonal antibodies that have the potential to be developed for the clinical management of solid tumors. Importantly, these antibodies showed differential binding to specific domains of NRP2, selectively inhibiting binding of either VEGF or Sema3F. In combination with chemotherapy, an antibody blocking the VEGF binding site of NRP2 was effective in preventing mammosphere formation in organoids derived from triple-negative breast cancer (TNBC) patients. Expression of NRP2 has been shown to be high in TNBC tumors and has been linked to worsened outcomes for patients. These results suggest that antibodies targeting NRP2 could potentially be effective in certain types of solid tumors, including breast cancer.

08:27 EDT Aqua Metals completes initial run of first V1.25 electrolyzer - Aqua Metals announced it has performed a test run of the first electrolyzer as part of its V1.25L program. The program consists of three iterations that are classified as V1.25a, V1.25b and the final iteration, V1.25L, the latter of which will be used to create the licensing ready AquaRefining electrolyzer package for the Company's equipment supply and licensing offerings. This first iteration of improvements, as pictured and captioned below, ran very well and as expected, produced ultra high-purity lead metal assayed at 99.99+%, consistent with lead production from the previous electrolyzers in 2019. The Company is utilizing and will continue to benefit from its stockpile of lead concentrate throughout the V1.25L program. As the Company prepares for the second iteration, additional runs of V1.25a will be performed consistently to further validate the initial improvements. The V1.25L program is expected to run for approximately six months, with the goal of completing the licensing ready V1.25L by the first quarter of 2021. Incremental iterations will be developed to validate each key set of improvements, allowing the focus to be on optimizing advances with each iteration. As previously communicated, the V1.25L program does not fundamentally change the key operating parameters of the AquaRefining electrolyzers. The program is designed to build upon previous operational success and target key areas of "case hardening," thus providing a strong and robust AquaRefining equipment value proposition to the marketplace.

08:26 EDT Onconova initiates Phase 1/2a study of rigosertib plus nivolumab - Onconova Therapeutics announced an investigator-initiated Phase 1/2a trial of oral rigosertib plus nivolumab in advanced metastatic KRAS mutated lung adenocarcinoma has begun enrolling patients. The investigator-initiated trial is an open-label, dose-escalating Phase 1 study followed by a Phase 2a dose-expansion phase to study the combination of oral rigosertib and nivolumab in metastatic KRAS+ lung adenocarcinoma patients who have progressed on standard frontline treatment. The study will assess safety and efficacy.

08:23 EDT Nelnet: DOE says company's proposal 'ineligible for award' - Nelnet announced that the U.S. Department of Education, Office of Federal Student Aid has notified the company that the company's proposal in response to the Business Process Operations component of the Department's Next Generation Financial Services Environment contract procurement process has been determined to be ineligible for award, claiming the company's response did not meet certain requirements related to small business participation. BPO is the back office and call center operational functions for servicing the Department's 43M student loan customers. Nelnet has requested a debriefing by the Department, and the company is considering its legal options, including filing a protest challenging the decision.

08:22 EDT Enphase Energy, ProSolar restore solar power at Bluebeard's Castle Resort - Enphase Energy announced that ProSolar Systems, a US Virgin Islands-based solar engineering, procurement, and construction firm, has used seventh-generation Enphase microinverters to restore and upgrade the commercial solar system at the historic Bluebeard's Castle resort in St. Thomas, U.S. Virgin Islands. Bluebeard's Castle resort solar system was initially commissioned in January 2014 with a rated capacity of 500 kW. Before the resort property and solar system were severely damaged by Hurricanes Irma and Maria in 2017, the system was composed of 1,887 solar modules and Enphase M250 microinverters, spanning 18 resort buildings and four ground-mounted arrays. The upgraded solar system features nearly 250 fewer solar modules, with 1,640 Enphase microinverters, but yields an upgraded system rating of 524 kW and projected annual energy savings of more than $350,000.

08:20 EDT Sarepta, Codiak collaborate to research, develop exosome-based therapeutics - Sarepta Therapeutics and Codiak BioSciences announced a global research and option agreement to design and develop engineered exosome therapeutics to deliver gene therapy, gene editing and RNA technologies for neuromuscular diseases. The engineered exosome approach offers the potential to effectively deliver genetic therapeutics without triggering the adaptive immune response. The two-year agreement includes up to five neuromuscular targets. Codiak is eligible to receive up to $72.5 million in upfront and near-term license payments plus research funding. Sarepta is granted an option to any of the candidates developed pursuant to the research alliance. Exosomes are natural nanoparticles that serve as the body's intercellular communication system, facilitating the transfer of a wide variety molecular payloads between cells. As they are derived from human cells, exosomes provide a unique advantage as a targeted delivery system for genetic medicines because they are inherently non-immunogenic. Through its proprietary, engEx Platform, Codiak can engineer exosomes with specific cargos and guide tropism to cell types of interest. The collaboration will leverage Codiak's exosome engineering capabilities with Sarepta's expertise in precision genetic medicine to develop next generation therapeutics for patients with neuromuscular diseases that have few or no treatment options. Under the terms of the agreement, Sarepta has the exclusive option to license Codiak's technology to develop and commercialize engineered exosome therapeutics for up to five neuromuscular targets. Sarepta and Codiak will collaborate to design exosomes that can deliver and functionally release select payloads, such as nucleic acids and gene therapy and gene editing constructs, in neuromuscular indications. If Sarepta elects to exercise its option on a target, Codiak will be responsible for research and preclinical development through IND preparation, and Sarepta will be responsible for clinical development and commercial activities. In addition to upfront, research funding and license payments, Codiak will be eligible to receive significant development and regulatory milestone payments and tiered royalties on future sales.

08:18 EDT MyoKardia reports data from Phase 2a trial of danicamtiv - MyoKardia announced the presentation and publication of positive data from the company's Phase 2a clinical trial of danicamtiv along with nonclinical data elucidating danicamtiv's novel mechanism of action. Results from both the clinical and nonclinical studies of danicamtiv were featured at the European Society of Cardiology's Heart Failure Association Discoveries online event and published simultaneously in the European Journal of Heart Failure. Danicamtiv is MyoKardia's most advanced clinical candidate being developed for the treatment of conditions driven primarily from reduced systolic function, including genetic dilated cardiomyopathy and other targeted segments of heart failure with reduced ejection fraction. Chronic HFrEF is a debilitating syndrome with a five-year mortality rate of 50 percent. In the Phase 2a study, danicamtiv, administered orally for seven days in patients with stable chronic heart failure, was generally well-tolerated, and was associated with clinically meaningful improvements in left ventricular contractility, including statistically significant increases in LV stroke volume, without impairing the heart's ability to relax and fill. Danicamtiv treatment also improved left atrial volume and function, a new and potentially important finding given left atrial size is a well-established prognostic factor for atrial fibrillation. Nonclinical studies also published as part of HFA Discoveries indicated danicamtiv directly activates the left ventricle and left atrium, providing compelling mechanistic rationale for the robust changes observed clinically. MyoKardia intends to advance danicamtiv into two Phase 2 clinical trials in distinct patient subgroups: dilated cardiomyopathy patients with certain genetic mutations, and patients with reduced systolic function and atrial fibrillation. Genetic mutations of the sarcomere impair the ability of the heart muscle proteins to function effectively, leading to progressive worsening of function. The genetic DCM Phase 2 study will test the hypothesis that danicamtiv may correct the main pathological driver of disease in certain types of genetic DCM. MyoKardia plans to start the Phase 2 genetic DCM study in the second half of 2020, pending circumstances related to the coronavirus pandemic. Atrial fibrillation co-exists with heart failure in approximately 35% of patients with HFrEF. Individuals with both conditions are known to suffer worse symptoms and outcomes, as most anti-arrhythmic therapies are not well tolerated or are contra-indicated. MyoKardia expects to initiate its Phase 2 study in patients with systolic heart failure and paroxysmal or persistent atrial fibrillation in the first half of 2021. The primary endpoint for the Phase 2a study was to assess the clinical safety and tolerability of danicamtiv in patients with chronic HFrEF. Danicamtiv was generally well tolerated with no dose-limiting toxicities observed. The safety profile was consistent with observations from MyoKardia's Phase 1 study in healthy volunteers. Adverse events reported during the treatment period were predominantly mild or not considered related to study treatment. AEs were reported by 57% of study participants in the active treatment arm and 40% of those on placebo. Cardiac AEs during treatment reported with danicamtiv included asymptomatic, mild, transient increases in troponin, ventricular extrasystoles, and in two patients, non-sustained ventricular tachycardia episodes which were observed at baseline and again during study treatment. All were mild, required no adjustment of medication and resolved without treatment. An analysis of Holter monitoring of cardiac rhythm in all patients revealed no increase in atrial or ventricular arrhythmias with danicamtiv compared with placebo. The one serious adverse event reported during the study was an incidence of hyperkalemia which resolved. This event occurred in the active treatment arm and was considered to be unrelated to study treatment by the investigator. Secondary and exploratory endpoints in the Phase 2a study focused on echocardiographic measures of danicamtiv's effects on systolic function, diastolic function and left atrial volume and function, as well as pharmacokinetics and pharmacodynamic measures. At concentrations higher than 2,000ng/mL, danicamtiv demonstrated clinically meaningful and statistically significant improvements in multiple measures of left ventricular contractility as compared to placebo. Stroke volume, global longitudinal and circumferential strain, and systolic ejection time improved with little to no clinically meaningful impact on diastolic function. New observations show a marked improvement in left atrial function and volume associated with danicamtiv treatment. Statistically significant, concentration-dependent improvements in left atrial volume and function were observed compared to placebo using multiple echocardiographic measures, including LA minimal volume, LA emptying fraction and LA function index. These left atrium parameters are strongly associated with adverse cardiovascular outcomes, including atrial fibrillation, heart failure and mortality. The Phase 2a study of danicamtiv was a randomized, double-blind, placebo-controlled, adaptive designed study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending oral doses of danicamtiv in patients with stable heart failure with reduced ejection fraction. A total of forty patients were randomized in consecutive cohorts: thirty patients received danicamtiv 50mg, 75mg, or 100mg twice daily for 7 days, and 10 patients received placebo.

08:18 EDT Fuling Global receives non-binding proposal to acquire company for $2.18/share - Fuling Global announced that its board of directors has received a preliminary non-binding proposal letter dated June 20, from Guilan Jiang, founder and chairwoman of the Board of the company on behalf of herself and her extended family members who are shareholders of the company, and Qijun Huang, an individual financial investor, to acquire all of the outstanding ordinary shares of the company that are not already held by the Buyer Group for a purchase price of $2.18 per share, in cash. The Proposed Transaction, if completed, would result in the company becoming a privately-held company owned by the Buyer Group, and the company's ordinary shares would be delisted from the NASDAQ Capital Market. The company has formed a special committee of the Board, composed of Hong He, Jian Cao and Fuyou Cai, each an independent and disinterested director, to consider the Proposal Letter and the Proposed Transaction. The company cautions that the Board has just received the Proposal Letter and has not made any decisions with respect to the Proposal Letter and the Proposed Transaction. There can be no assurance that the Buyer Group will make any definitive offer to the company, that any definitive agreement relating to the Proposal Letter will be entered into between the company and the Buyer Group, or that the Proposed Transaction or any other similar transaction will be approved or consummated. The company does not undertake any obligation to provide any updates with respect to this or any other transaction, except as required under applicable law.

08:13 EDT Mateon Therapeutics, GMP complete research, service agreement - Mateon Therapeutics announces that both Golden Mountain Partners and Mateon have fulfilled all the obligations under the Research and Services Agreement entered on February 3, 2020 and modified on March 22, 2020. The terms and obligations of the agreements have been met by both parties. GMP and Mateon are now moving forward with the clinical development of OT-101, Artemisinin, and other antisense drug candidates against SAR-CoV-2.

08:12 EDT Rubius Therapeutics highlights preclinical data for RTX-321 - Rubius Therapeutics announced the presentation of preclinical data supporting its lead artificial antigen-presenting cell program, RTX-321, for the potential treatment of human papillomavirus 16-positive cancers during the American Association for Cancer Research Virtual Annual Meeting II. In Vivo Efficacy and Pharmacodynamic Analysis of RTX-321, an Engineered Allogeneic Artificial Antigen Presenting Red Cell Therapeutic: RTX-321 is an investigational allogeneic aAPC therapy that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses an HPV peptide antigen bound to major histocompatibility complex class I proteins, 4-1BBL - a co-stimulatory signal - and IL-12 - a cytokine - on the cell surface to mimic human T cell-APC interactions. Treatment with mRBC-321, a mouse surrogate of RTX-321, leads to tumor cures and long-term memory based on protection from re-challenge with tumor cells. Protection of mice challenged with parental cells lacking the original antigen strongly suggests treatment with mRBC-321 promotes epitope spreading. mRBC-321 inhibits tumor growth without adoptive transfer, which is correlated to endogenous T cell expansion in the tumor. RTX-321 activates and expands HPV-antigen-specific TCR-transduced primary T cells in vitro. Overall, mRBC-321 and RTX-321 can selectively engage and activate antigen-specific T cells, allowing for robust expansion and differentiation into effector and long-lasting anti-tumor memory cells. Taken together, these findings support the potential of RTX-321 as an effective treatment for HPV 16-positive cancers.

08:10 EDT Catalyst Biosciences appoints Charles Democko as SVP, regulatory affairs - Catalyst Biosciences announced the appointment of Mr. Charles Democko as Senior Vice President, Regulatory Affairs. Democko will lead the regulatory efforts for the Company's rare hematologic and systemic complement-mediated disorders portfolio. Democko joins Catalyst from CytomX, where he led the Company's regulatory affairs and quality.

08:08 EDT VBL Therapeutics presents MOSPD2 bi-specific antibody activity - VBL Therapeutics presented a late-breaking study showing that its proprietary MOSPD2 bi-specific antibody candidates induced T-cell activation and significantly extended the survival of animals carrying established metastatic cervical and breast cancer. Data are presented at the American Association for Cancer Research Virtual Annual Meeting II, being held June 22-24, 2020. VBL's research has identified MOSPD2 as a protein involved in cell motility, whose expression is highly elevated in various solid tumors. The proprietary bi-specific antibody candidates developed by VBL have two separate arms - one arm binds to MOSPD2 on tumor cells and the second recruits host T-cells that attack the tumor. The data presented today demonstrate that the company's bi-specific antibody candidates: mediated killing of tumor cells by CD8 T-cells in a dose-dependent manner; induced T-cell activation in-vivo; and extended survival of tumor-bearing animals. The results highlight the potential of MOSPD2-mediated immuno-oncology therapy for the treatment of various solid tumors.

08:07 EDT Athenex announces $225M loan agreement with Oaktree - Athenex announced that it has entered into a $225 million loan agreement with funds managed by Oaktree Capital Management. The Company expects the proceeds from the financing will be used to fund the commercial launch of oral paclitaxel and encequidar, ongoing pipeline development, refinancing of existing indebtedness, manufacturing infrastructure, and working capital and general corporate purposes. The Agreement provides Athenex with up to $225 million of capital. $100 million is being funded up front, with a portion of the upfront loan proceeds being used to repay in full the existing debt facility with the Perceptive Credit Opportunities Fund. Additional debt tranches of $125 million in aggregate are available subject to Athenex's achievement of certain regulatory and commercial milestones. The loan matures in June 2026. Further information with respect to the term loan is set forth in a Form 8-K filed by Athenex with the Securities and Exchange Commission on June 22, 2020.

08:07 EDT Royal Caribbean, Cruises Investment to reorganize Pullmantur joint venture - Cruises Investment Holding and Royal Caribbean Group said they have filed for the reorganization of their Pullmantur Cruceros joint venture under the terms of Spanish insolvency laws. Cruises Investment Holding owns 51% of the Spanish cruise line, while RCL owns the remaining 49%. Pullmantur's board of directors determined that the unprecedented impact of the COVID-19 pandemic made the action necessary. Pullmantur management notified employees of the decision after filings were made with Spanish authorities. "Despite the great progress the company made to achieve a turnaround in 2019 and its huge engagement and best efforts of its dedicated employees, the headwinds caused by the pandemic are too strong for Pullmantur to overcome without a reorganization," the board stated. The company canceled sailings through November 15, 2020. Royal Caribbean Group said that guests already booked to sail on Pullmantur will be offered the option to sail on other RCL brands including Royal Caribbean International and Celebrity Cruises. Pullmantur noted that details of the offer will be shared with guests in the near future. Crew are staffed at minimum maintenance levels on Pullmantur's three ships and the company will take care of their safe return home. RCL noted that all of its assets related to the Pullmantur Cruceros joint venture had been included in the non-cash asset impairment charges reported in their first quarter of 2020 results.

08:06 EDT Ayala Pharmaceuticals on track to initiate Phase 2 trial of AL101 in 2H20 - Ayala plans to initiate a Phase 2 clinical trial of AL101 for the treatment of patients with R/M TNBC with Notch-activating mutations in the second half of 2020, subject to the impact of COVID-19.

08:05 EDT Grid Dynamics announces partnership with Dataiku - Grid Dynamics announced a partnership with Dataiku, one of the world's leading Enterprise AI platforms. Grid Dynamics said in a release, "The partnership brings together one of the most powerful toolkits for data preparation and ML models deployment, deep skills in business and technology strategy, and many years of experience in implementing data science and machine learning programs for Fortune 1000 clients."

08:04 EDT Halozyme to receive $10M milestone payment from Janssen - Halozyme Therapeutics announced the company will receive a $10M milestone payment from Janssen Biotech triggered under the Collaboration and License Agreement between the two companies. The milestone payment is associated with the first commercial sale in the European Union of Janssen's subcutaneous formulation of DARZALEX utilizing ENHANZE, which was recently granted marketing authorization by the European Commission.

08:04 EDT Vale announces agreements for sale of minority equity stake in PT Vale - Vale SA informs that its subsidiary Vale Canada Limited, or "VCL," has signed, together with Sumitomo Metal Mining, the definitive agreements for the sale of a 20% stake of PT Vale Indonesia Tbk to PT Indonesia Asahan Aluminium. After the closing of the transaction, Inalum will have acquired 20% of PT Vale shares, being 14.9% from VCL and 5.1% from SMM. Vale and SMM will then have a stake of 44.3%2 and 15.0% in PT Vale, totalling a 59.3% participation. For its stake, VCL will receive IDR 4,126 billion, or approximately $290M in cash, upon closing of the transaction, which is expected to happen by the end of 2020, after the satisfaction of standard regulatory approvals.

08:03 EDT AbbVie's Allergan announces FDA accepts sBLA for Botox - Allergan announced that the U.S. FDA has accepted the company's supplemental biologics license application to expand the Botox prescribing information for the treatment of signs and symptoms of detrusor overactivity associated with an underlying neurologic condition in pediatric patients who have an inadequate response to, or are intolerant of, or for any reason unwilling to continue anticholinergic medication. The sBLA is based on data from a randomized, double-blind Phase 3 study evaluating the safety and efficacy of Botox in more than 100 pediatric patients with neurogenic detrusor overactivity and a long-term extension study. The Prescription Drug User Fee Act date is expected to be in the first quarter of 2021 following a standard 10-month review.

08:01 EDT Kirkland Lake Gold appoints Greg Gibson as special advisor to CEO - Kirkland Lake Gold announced a number of management appointments intended to enhance the depth and effectiveness of the Company's leadership team as it moves forward as a leading senior gold producer with industry-leading financial performance and strength. All appointments listed below are effective immediately. Among the appointments: Greg Gibson joins the Company as Special Advisor to the CEO, Business Process Improvement; Natasha Vaz is promoted to Senior Vice President, Technical Services and Innovation from her current position of Vice-President, Technical Services; Jennifer Wagner is promoted to Senior Vice President, Corporate Affairs, Legal Counsel and Corporate Secretary from Vice President, Legal; Mark Utting is promoted to Senior Vice President, Investor Relations from Vice President, Investor Relations; Mohammed Ali is promoted to Vice President, Environment from Director, Environmental Affairs, Canadian Operations; Duncan King is appointed Vice President, Canadian Operations from his current role of Vice President, Australian Operations on an interim basis; John Landmark and Brian Hagan are appointed Co-Leads of Australian Operations on an interim basis, from their current positions of Vice President, Human Resources and Vice President, Northern Territory Operations, respectively; David Londono is appointed Vice President, Special Projects from his current role of Mine General Manager, Detour Lake Mine; and Evan Pelletier is promoted to Vice President, Mining from General Manger, Mining.

07:48 EDT Molecular Templates provides update on Phase 1 study of MT-5111 - MT-5111, a HER2 targeted ETB, is in an ongoing Phase 1 study that has two parts: Part 1 is dose escalation and Part 2 is dose expansion, which will begin when a maximum tolerated dose or Recommended Phase 2 Dose is established in Part 1. To date, 10 subjects, with a median of 5 prior lines of therapy and a median of 2 prior HER2-targeting regimens, have been treated with MT-5111. Thus far, no dose limiting toxicities have been observed in any cohort and MT-5111 appears to be well tolerated, with no cardiotoxicity to date. Currently there are 4 subjects in total on treatment from the second and third cohorts. No cardiac AEs or abnormalities in cardiac biomarkers have been noted thus far. Reported AEs that may be causally related among the 3 cohorts to date include the following: one instance of grade 1 chills, one instance of grade 1 hypophosphatemia, one instance of grade 1 nausea, and one instance of grade 2 AST elevation. The grade 2 AST elevation occurred in a subject in cohort 1 with disease progression in hepatic metastases; no causally related AST or ALT elevations have been noted in any other subjects to date. The ongoing subject from cohort 2 has stable disease and remains on treatment, now in cycle 5. One subject in cohort 3 with metastatic breast cancer has had a follow-up CT scan at the end of cycle 2 and has stable disease. Six subjects have discontinued for disease progression and two subjects are too early to evaluate. Cohort 4 is anticipated to open shortly. Molecular Templates is encouraged by the safety profile to date in these heavily pretreated patients and expects to provide an update on results from the patients currently on treatment as well as higher dose cohorts from the dose escalation portion of the Phase 1 study in 4Q20.

07:43 EDT Conformis receives 510(k) clearance for iTotal Identity PS - Conformis announced 510(k) clearance by the U.S. Food and Drug Administration of the Company's next generation iTotal Identity PS Knee System. The iTotal Identity PS Knee System uses proprietary advanced imaging and design software, to deliver a patient-specific, pre-operative surgical plan with a comprehensive set of iJig instruments and patient-matched implants. Updates to this system include stem extensions available for patients with high Body Mass Index, titanium tibial baseplates with patient-specific cement rails, and metal cut guides and refined iJigs for a more traditional bone cutting experience.

07:37 EDT Essa Pharma presents new preclinical data on EPI-7386 - ESSA Pharma presented new preclinical data on ESSA's clinical candidate, EPI-7386, at the 2020 American Association for Cancer Research Virtual Annual Meeting II. The studies highlight new information about EPI-7386 including: Full-length AR target engagement by EPI-7386 was confirmed in a cellular thermal shift assay. In vitro cellular gene expression analyses demonstrate that EPI-7386: Inhibits AR transcriptional activity similar to enzalutamide but with a few notable qualitative and quantitative differences in an enzalutamide-sensitive cellular model. In the same cellular model, combination treatment of EPI-7386 with enzalutamide displays broader and deeper inhibition of AR-associated transcriptional activity than higher doses of each single agent alone. Shows superior activity to enzalutamide in an AR-V7-driven cellular model by modulating both AR-FL and AR-V7-driven gene expression.Toxicology studies evaluating the safety profile of EPI-7386 demonstrate that: Very high plasma exposures of EPI-7386 were achieved across all studies. Tolerability in 28-days tox studies in rats and dogs at AUC less than or equal to 2,000,000 ng hr/mL, with activity seen on androgen-sensitive target organs in dogs. The highest doses tested were characterized as the HNSTD (highest non-severely toxic dose) and only exhibited body weight loss and reduced food consumption. The drug plasma exposures achieved at this high dose were 7-10 fold higher than the efficacious exposures achieved in mouse xenograft models. The starting clinical dose of EPI-7386 will be 200 mg given once-daily.

07:37 EDT THRC Holdings reports 8.26% passive stake in QEP Resources

07:35 EDT Theratechnologies announces new data on SORT1+ technology - Theratechnologies announced that new data featuring its investigational sortilin 1-targeting peptide-drug conjugate technology will be presented in three posters at the American Association for Cancer Research's virtual annual meeting II. The formation of microvascular channels leads to aggressive, metastatic and resistant cancer cells and is known as vasculogenic mimicry. VM is believed to be associated with tumor growth, resistance and poor prognosis in many types of aggressive cancers including ovarian and triple-negative breast cancer. Results presented at AACR indicate that SORT1 is highly expressed in cancer cells involved in the VM process in both ovarian cancer and TNBC. In addition, CD133, a gene associated with cancer stem cells, is also highly expressed during VM formation. Theratechnologies' SORT1-targeting peptide-drug conjugates TH1902 and TH1904 strongly inhibit VM at very low doses. When administered alone, docetaxel and doxorubicin show no effect at therapeutic doses. The poster "Sortilin receptor-mediated novel cancer therapy: A targeted approach to inhibit vasculogenic mimicry in ovarian and breast cancers" is now available online at aacr.org. Science has identified several compounds in nature that have cancer-fighting potential. However, these compounds are often unstable or need to be taken in quantities that are unrealistic. Phytochemicals found in plants, such as curcumin, are proven to have antiproliferative, antiangiogenic and apoptotic properties against various cancers such as colorectal, ovarian and breast cancers. However, when administered alone, these phytochemicals have low bioavailability and are rapidly degraded and poorly absorbed through the gastro-intestinal tract. The results of a preclinical study, where curcumin was conjugated with Theratechnologies' proprietary peptide and delivered directly to cancer cells, show that TH1901 has 50 to 100 times greater anti-cancer activity than curcumin alone in ovarian, breast, melanoma and colorectal cancer models in vitro. The poster "TH1901, a novel Curcumin-peptide conjugate for the treatment of Sortilin-positive cancer" is now available online at aacr.org TNBC, which represents approximately 10 to 20% of breast cancers, does not express estrogen receptors, progesterone receptors or human epidermal growth factor receptor 2. It is more aggressive than other breast cancers and it has been observed that TNBC overexpresses SORT1 receptors. In a poster presented at AACR, preclinical data demonstrate that in vitro TH1902 leads to significantly better efficacy at a lower dose when compared to docetaxel alone. In the same study, TH1902 also shows similar efficacy to therapeutic doses of docetaxel when administered only at one-quarter of the indicated dose of docetaxel. When administered alone, docetaxel showed no treatment effect at the one-quarter dose. In addition, the safety profile of TH1902 was superior to docetaxel as it did not induce neutropenia even after six treatment cycles. A single 15mg/kg dose of docetaxel alone was enough to induce neutropenia. The poster "A novel Sortilin-targeted docetaxel peptide conjugate, for the treatment of Sortilin-positive triple-negative breast cancer" is now available online at aacr.org.

07:33 EDT Heat Biologics treats first patient in PTX-35 first-in-human clinical trial - Heat Biologics announced that the first patient has been treated in the Company's first-in-human Phase 1 clinical trial evaluating PTX-35, the first antibody product candidate developed by Heat Biologics' Pelican Therapeutics subsidiary. Heat said in a release, "This first-in-human study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care. Eligible patients will be enrolled to receive PTX-35 every two weeks until disease progression. Escalating dose levels of PTX-35 will be explored until optimal immunological dose or maximum tolerated dose is established. The objectives of the study include safety evaluation, determination of the recommended Phase 2 dose as well as exploratory analyses of clinical benefit and immunological effect of PTX-35. This trial is supported by a $15.2 million grant from the Cancer Prevention and Research Institute of Texas."

07:32 EDT Revolution Medicines doses first patient in study of RMC-4630, PD-1 inhibitor - Revolution Medicines (RVMD) announced dosing of the first patient in a multicenter Phase 1 clinical trial evaluating the combination of RMC-4630, the company's investigational SHP2 inhibitor, and pembrolizumab, an anti-PD-1 antibody. The trial, which is being sponsored and conducted by the company's collaboration partner Sanofi (SNY), is an open-label, safety, preliminary efficacy and pharmacokinetics study in participants with advanced malignancies. This will include patients with non-small cell lung cancer who have progressed on or after platinum-based chemotherapy, and patients with colorectal cancer who have progressed on or after standard of care therapy. RMC-4630 is a potent and orally bioavailable small molecule that is designed to selectively inhibit the activity of SHP2, an upstream cellular protein that plays a central role in modulating cell survival and growth by transmitting signals from receptor tyrosine kinases to RAS. Pembrolizumab, a humanized antibody used in cancer immunotherapy, is designed to selectively inhibit the activity of PD-1, a key immune checkpoint that can prevent the immune system from targeting and killing cancer cells. Pembrolizumab is an approved standard of care for the treatment of NSCLC, including lung cancers harboring RAS pathway mutations. The company's recently published research in the journal Cancer Research described the anti-tumor effects of a SHP2 inhibitor such as RMC-4630 through modulation of key elements of the immune system in preclinical cancer models. These findings demonstrated that inhibition of SHP2 may exert therapeutic anti-tumor effects by modulating multiple arms of the immune response to the tumor in addition to reducing oncogenic signaling within tumor cells themselves. Importantly, these data indicate that these two mechanisms may be additive in their anti-tumor impact. Additionally, company findings from the same preclinical study showed that when the SHP2 inhibitor was combined with an immune checkpoint inhibitor (anti-PD-1), deep and durable tumor growth inhibition was observed, with complete tumor regressions and sustained immunological memory in some mice.

07:31 EDT SL Green Realty announces departure of co-Chief Investment Officer Isaac Zion - SL Green Realty announced that Isaac Zion, Co-Chief Investment Officer, will leave the company effective July 31 to pursue new professional interests. The day-to-day operations of the Investments team will continue to be led by David Schonbraun, Chief Investment Officer, along with Managing Directors, Brett Herschenfeld and Robert Schiffer.

07:24 EDT Rexford Industrial acquires two industrial properties for $14.7M - Rexford Industrial Realty announced the acquisition of two industrial properties for $14.7M. The acquisitions were funded using cash on hand as well as the assumption of existing debt on one of the properties. The company acquired 22895 Eastpark Drive, located in Yorba Linda within the Orange County - North Submarket, for $6.8M, or $196 per square foot. The company also acquired 8745 and 8775 Production Avenue, located in San Diego within the San Diego - Central submarket, for $7.9M, or $167 per square foot.

07:20 EDT Tela Bio to join the Russell 2000 Index - TELA Bio announced that the company will be added to the Russell 2000 Index at the conclusion of the Russell U.S. Indices annual reconstitution, effective after the U.S. market opens on June 26, 2020.

07:18 EDT Alio Gold, Argonaut Gold receive Mexican anti-trust approval - Argonaut Gold (ARNGF) and Alio Gold (ALO) announced the receipt of the clearance decision from the Comision Federal de Competencia Economica with respect to the pending merger between Argonaut Gold and Alio Gold. COFECE approval was the final government agency approval required before completing the merger, which is anticipated to occur between June 29, 2020 and July 3, 2020.

07:16 EDT Hookipa Pharma announces Phase 2 interim safety results for HB-101 - HOOKIPA Pharma announced positive interim results on its prophylactic Cytomegalovirus vaccine candidate HB-101. HB-101 is being investigated in a double-blind Phase 2 clinical trial to assess safety, immunogenicity and efficacy in patients receiving a kidney transplant from a live donor. HOOKIPA reported interim data on the trial's primary endpoints, safety and B cell and T cell immunogenicity. Trial participants were blinded and randomized 2:1 to receive either HB-101 or placebo. Patients received either 2 or 3 doses prior to transplantation, depending on the transplantation time schedule. Safety and tolerability were evaluated in 51 CMV-negative patients prior to kidney transplantation. Of the 51 patients, only eight patients across the combined, blinded HB-101 and placebo groups showed adverse events related to the administration. Most of these adverse events were of mild intensity, indicating that HB-101 is generally well tolerated in this patient population. Of note, this target patient population reported fewer adverse events than the 54 healthy volunteers in HOOKIPA's recently published Phase 1 trial results. For the interim analysis, CMV-neutralizing antibody titers on the day of transplantation were evaluated in all of the 30 CMV-negative patients who had been transplanted by the cutoff date and had valid results. Nineteen of the 30 patients received HB-101 and eleven received placebo. All five patients who received three doses of HB-101 mounted CMV-neutralizing antibodies. Three of the fourteen patients who received only two doses of HB-101 also mounted CMV-neutralizing antibodies. The antibody response of the kidney transplant recipients who completed the three-dose regimen was comparable to the antibody response observed in the Phase 1 trial. Cellular immune responses to CMV on the day of transplantation were evaluated in 25 CMV-negative patients who had been transplanted in time for this interim analysis. Technically valid results from T cell assays on the day of transplantation were available for seven recipients. Two of the seven patients received placebo and five received HB-101. All three patients who received three doses of HB-101 and one of the two patients who received only two doses mounted a CMV-specific cellular immune response. The interim data demonstrate that HB-101 is well tolerated with fewer adverse events in patients with end-stage kidney disease than in the previous healthy volunteer trial. Patients who received three doses of HB-101 show comparable immunogenicity to healthy volunteers in HOOKIPA's Phase 1 clinical trial of HB-101.

07:15 EDT Applied Genetic provides update on productivity, quality improvements - Applied Genetic Technologies provided an update on the continued productivity and quality improvements made in its proprietary manufacturing platform that is currently being used to create clinical trial material for the Company's planned pivotal clinical trials in X-linked retinitis pigmentosa. "Continuous improvements to our proprietary HSV-based manufacturing process have been a critical AGTC objective for more than a decade, and our efforts have resulted in AAV vector quality and yields that we believe exceed the performance and economics of other currently available approaches to produce AAV gene therapy products, particularly those using adherent cell platforms," said Dr. Dave Knop, PhD, Head of Process Development at AGTC. "We are now achieving finished product specifications that demonstrate nearly 90% full capsids with extremely low residuals, many of which fall below the level of detection, resulting in purity levels exceeding 97%. This is in addition to yields that are more than 10-fold higher than what we achieved in our Phase 1/2 manufacturing campaigns. What this means is we are already at commercial scale manufacturing for our ophthalmology programs since we can produce thousands of low cost doses from a 40L bioreactor, and our scalable bioreactor format is designed to enable us to meet the production demands for large market indications and indications that may require substantially higher dosing."

07:12 EDT Autolus Therapeutics presents preclinical data on AUTO3, AUTO6NG - Autolus Therapeutics announced preclinical data related to AUTO5 in T cell lymphoma and AUTO6NG in small cell lung cancer, as well as an oral presentation related to AUTO7 in prostate cancer at the American Association for Cancer Research Virtual Annual Meeting II on June 22 - 24, 2020. AUTO7: Anti-PSMA humanized CAR T cell with improved persistence and resistance to tumor microenvironment for metastatic castration resistant prostate cancer: AUTO7 is a multi-modular CAR T cell program aimed at generating resilient CAR T cells that can withstand the hostile solid tumor microenvironment. By introducing Autolus' proprietary programming modules, the new data demonstrate a positive effect on tackling the complex tumor biology in a metastatic, castration-resistant prostate cancer setting. AUTO7 uses an optimized CAR to target cancer cells expressing PSMA, even at low levels, and includes four of Autolus' suite of cell programming modules to overcome tumor defenses and enhance efficacy: the dSHP2 programming module shielding AUTO7 from checkpoint inhibition, the dominant negative TGFbetaRII module acting as a decoy for inhibitory TGFbeta signaling, the IL7 chimeric cytokine receptor module enhancing CAR T cell survival, and finally, a module that activates immune responses at the tumor site through limited secretion of IL-12. All programming modules provide their effect within the CAR T cell and the immediate surrounding environment, rather than having a systemic effect with its potential associated systemic toxicities. The preclinical data presented by Autolus demonstrate that AUTO7 is highly potent in cytotoxicity assays against cells expressing PSMA, even at low levels, and demonstrate the feasibility of this multi-modular cell programming approach in overcoming the immunotherapeutic challenges presented by advanced prostate cancer, which is typically otherwise an immunologically cold tumor. AUTO6NG overcomes immune suppressive mechanisms in the TME and demonstrate preclinical anti-tumor activity in GD2-expressing solid tumors: AUTO6 is a GD2-targeting CAR T candidate, developed in collaboration with UCL, that has been shown to be clinically active in neuroblastoma. GD2 has been evaluated and validated as an attractive CAR T target antigen in small cell lung cancer. AUTO6 alone has demonstrated efficacy in an in vitro SCLC model, but successful tumor targeting alone was not sufficient to drive in vivo efficacy in the same SCLC model. Autolus has designed enhancing modules to specifically overcome TME defenses in solid tumor settings. In addition to the original AUTO6 GD2 CAR and safety switch, the company has tested the impact of adding its dSHP2 module, its dominant negative TGFbetaRII module and its IL7 CCR module, as described above. Autolus has presented new preclinical data demonstrating the validity of GD2 as a CAR T target in SCLC and the ability of these efficacy-enhancing modules to drive in vivo efficacy in an SCLC mouse model. The new data presented by Autolus suggest that AUTO6NG can overcome the immune suppressive mechanisms in the TME. AUTO5: Targeting TRBC2 for the treatment of T cell lymphomas: There is currently no approved programmed T cell therapy available as a stand-alone treatment for T cell lymphomas. AUTO4 is the company's TRBC1 CAR T cell candidate aimed at targeting TRBC1+ patients. AUTO5, a novel CAR T candidate targeting the TRBC2+ population, is designed to capture the remaining 60% of the T cell lymphoma population. Autolus has presented data showing that AUTO5 is able to selectively target TRBC2+ and spare TRBC1+ cells in a mixed healthy peripheral blood mononuclear cells population. The company demonstrates that its novel anti-TRBC2 binder incorporated in a second-generation CAR with optimized architecture can selectively kill TRBC2+ T cells of healthy PBMC donors. Alongside the killing efficiency, AUTO5 is also capable of specific cytokine release and proliferation in response to interaction with TRBC2 target cells. The same specific killing effect was observed in vivo when mice were challenged in a co-infused mixed TRBC1/TRBC2 tumor model. The anti-TRBC2 CAR was able to clear the TRBC2+ T cells, while sparing the TRBC1+ T cell population. These data highlight the specificity and selectivity of the company's T-cell lymphoma product candidate, AUTO5.

07:09 EDT Bicycle Therapeutics presents new data for BT5528 - Bicycle Therapeutics announced that new translational data for BT5528 and preclinical data for tumor-targeted immune cell agonists will be presented during poster sessions at the American Association for Cancer Research Virtual Annual Meeting II on June 22-24, 2020. New translational data for BT5528, a second-generation Bicycle Toxin Conjugate (BTC) that targets EphA2, describe the development of Bicycle's proprietary IHC assay. This assay will be used to support patient selection and assess EphA2 expression levels in tumor samples collected in the ongoing Phase I/II trial of BT5528. EphA2 is a well-known tumor antigen shown to be overexpressed in a range of difficult to treat solid tumor types. While many independent EphA2 IHC assays have been reported, Bicycle's is the first to specifically detect the extracellular domain of EphA2 and to score its expression at both the tumor cytoplasm and tumor membrane, which is where BT5528 binds. Bicycle TICAs are potent, fully synthetic compounds that represent an immuno-oncology approach engineered to overcome the limitations of other immunomodulatory mechanisms. At AACR, the Company will present new preclinical data for BT7480, a TICA targeting Nectin-4 and agonizing CD137 (4-1BB), indicating that anti-tumor responses in a syngeneic mouse model can be achieved with an intermittent dosing regimen, which suggests that continuous target coverage may be unnecessary for efficacy. Additional PK/PD and safety data for BT7480 from in vivo mouse and non-human primate models demonstrate potent, target-dependent anti-tumor activity. At dose levels tested, BT7480 has been shown to be well-tolerated in preclinical species, with no signs of toxicity issues associated with other immuno-oncology agonist therapies. IND-enabling activities for BT7480 are ongoing. New preclinical data for EphA2/CD137 TICAs similarly indicate highly target dependent CD137 agonism, most notably in a syngeneic mouse model that showed robust antitumor activity. Complete responder animals in this model were subsequently re-challenged with the same tumor cell implantation and no tumor growth was observed, implying development of immunogenic memory. In further PK/PD experiments, intermittent plasma exposure of an EphA2/CD137 TICA produced robust anti-tumor activity, again implying continuous target coverage is not required for efficacy. Earlier this year, Bicycle selected BT7455, an EphA2/CD137 TICA, as another Bicycle-based immuno-oncology candidate to advance into clinical studies.

07:07 EDT Esperion, Daiichi Sankyo Europe amend license agreement - Esperion (ESPR) announced the completion of an amendment to the EU commercial collaboration agreement with Daiichi Sankyo Europe (DSKNY). Earlier this month, Esperion completed the transfer to DSE of Marketing Authorization Approvals for NILEMDO and NUSTENDI. DSE will now pay Esperion the second $150M milestone based on completion of the MAA transfer rather than the first commercial product sale in the EU, as previously agreed. The acceleration of the $150M milestone payment from DSE was made as a result of an amendment to the License and Collaboration Agreement between the two companies, originally signed in January 2019, which also added Turkey to existing rights covering the European Economic Area and Switzerland. Previously, the milestone payment was due upon the first commercial product sale in Europe. Under terms of the collaboration agreement with DSE, Esperion is eligible to receive up to $900 million in total milestones as well as tiered royalties between 15% - 25%. Upon receipt of the $150M milestone payment later this month, Esperion will have received $300M in total milestone payments.

07:06 EDT Invitae to acquire ArcherDX in deal valued at approximately $1.4B - Invitae and ArcherDX announced the companies have entered into a definitive agreement under which Invitae will combine with ArcherDX to create a genetics leader with unrivaled breadth and scale in cancer genetics and precision oncology. Under the terms of the agreement, Invitae will acquire ArcherDX for upfront consideration consisting of 30M shares of Invitae common stock and $325M in cash, plus up to an additional 27M shares of Invitae common stock payable in connection with the achievement of certain milestones, for an overall transaction valued at approximately $1.4B. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in several months, subject to customary closing conditions including approval by the stockholders of Invitae and ArcherDX. Invitae's current expectations regarding its cash at transaction close would be approximately $425M and its annualized near-term forward cash burn is expected to be approximately $130M.

07:05 EDT Altimmune announces IND clearance for Phase 2 trial of HepTcell - Altimmune announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to conduct a Phase 2 trial of HepTcell, a peptide-based immunotherapeutic for the treatment of chronic hepatitis B. The Company is also filing clinical trial applications in Canada, Spain, Germany and the United Kingdom. Altimmune plans to initiate a multinational trial in Q4 of this year, subject to an ongoing assessment of the impact of COVID-19 on study conduct. According to World Health Organization estimates, chronic HBV affects 292 million worldwide, and nearly 900,000 people die annually of complications of the disease. There is no cure for chronic HBV, and currently available antiviral medications only control the disease and require life-long treatment. These treatments represent a significant burden for chronic hepatitis B patients, considering life-long commitment to medication and monitoring costs. If left untreated, chronic HBV infection can lead to serious health issues including cirrhosis, liver failure and liver cancer. HepTcell is an immunotherapeutic product candidate composed of nine synthetic HBV-derived peptides formulated with IC31, a TLR9-based adjuvant from Valneva SE. The HBV peptides were designed to drive T cell responses against all HBV genotypes in patients of diverse genetic background. In the Phase 1 clinical study conducted in the United Kingdom and South Korea, three monthly injections at two dose levels of HepTcell peptides were given with and without IC31 adjuvant as add-on therapy to entecavir or tenofovir in patients with Hepatitis B e-antigen-negative chronic infections. All arms were generally well-tolerated and both high and low doses of HepTcell given in combination with IC31 resulted in potent T cell responses against HBV antigens - representing a break in immune tolerance with no evidence of immune-mediated adverse events. Acute HBV infections are cleared through a T cell-dependent immune response. However, in chronically infected patients, high viral antigen load can induce a state of immune tolerance that prevents T cells from clearing the infection. Breaking immune tolerance is considered essential to achieving a functional cure, defined as the loss of hepatitis B surface antigen in the blood. Ultimately, the goal of all HBV therapeutics in current development is to achieve a functional cure by reactivating the T cell immune response and overcoming immune tolerance, either indirectly by further lowering HBV antigen load or directly, as is the goal of HepTcell. The double-blind, randomized, placebo-controlled Phase 2 study of HepTcell plans to recruit 80 adult subjects with HBeAg-negative chronic HBV infection and low HBsAg levels. This patient population was selected as it is envisioned to mimic the HBV status of the patient population when HepTcell is combined with a novel direct-acting antiviral in subsequent trials. HepTcell will be administered intramuscularly at intervals of 4 weeks for 6 doses. The primary endpoint will be the virological response, defined as a 1-log reduction in HBsAg levels; secondary endpoints will incorporate safety, immunologic criteria, and other assessments of virologic response.

07:04 EDT Invitae to combine with ArcherDX

07:02 EDT AdvanSix appoints Kelly Slieter as Chief Human Resources Officer - AdvanSix (ASIX) announced the appointment of Kelly Slieter as Senior Vice President and Chief Human Resources Officer. AdvanSix said in a release, "In this role, Ms. Slieter will be responsible for leading the Company's human resources organization including talent management, leadership development and training, compensation and benefits, and communications. Ms. Slieter will report directly to Erin Kane, president and CEO of AdvanSix, and be a member of the Company's executive leadership team. Ms. Slieter joins AdvanSix having most recently served as Vice President of Human Resources within the Performance Materials and Technologies division of Honeywell International (HON)."

07:00 EDT Sherwin-Williams raises Q2 revenue view

06:57 EDT Mosaic reports refinancing of Saudi Arabian joint venture - Mosaic reports that Ma'aden Wa'ad Al Shamal Phosphate Company, or MWSPC, a subsidiary of Saudi Arabian Mining Company in which Mosaic holds a 25 percent interest, has completed the refinancing of its project level debt. Mosaic said in a release, "This refinancing marks MWSPC's transition to its operational financial structure as the joint venture completes its ramp up to full capacity. This refinancing: Removes recourse to Mosaic by all lenders to MWSPC, and Defers principal paydown until June 30, 2022, enhancing expected free cash flow. In addition, Mosaic's contractual commitment to make future cash contributions to MWSPC has now been eliminated."

06:49 EDT Virgin Galactic signs Space Act Agreement with NASA - Virgin Galactic announced the signing of a Space Act Agreement with NASA's Johnson Space Center to encourage commercial participation in orbital human spaceflight to the International Space Station while enabling the development of a robust economy in Low Earth Orbit. Under the agreement, Virgin Galactic will develop a new private orbital astronaut readiness program. This program will include identifying candidates interested in purchasing private astronaut missions to the ISS, the procurement of transportation to the ISS, on-orbit resources, and ground resources. Supporting and coordinating the use of ISS resources will be an important point of integration required for each private astronaut mission. The next generation of space traveler is interested in a variety of space experiences. Building on its commercial spaceflight training experience, Virgin Galactic believes it can provide an unparalleled, personalized customer experience for orbital space travel. As part of this partnership, NASA will leverage Virgin Galactic's commercial expertise and industry knowledge. Virgin Galactic will also contribute end-to-end program management and integrated astronaut training packages for private passengers, tailored to meet the needs for a commercial orbital space flight experience. The partnership also serves as a pathfinder for the ISS National Laboratory by demonstrating additional involvement by the commercial sector in human spaceflight, and may lead to commercial participants conducting research and other commercial activities aboard the ISS.

06:40 EDT Armour Residential raises monthly dividend guidance to 10c per share for Q3 - The company sees monthly dividends of 10c per share for July, August, and September. Armour previously announced the resumption of monthly dividends for its common stock with a 9c cash dividend per share payable on June 29 to holders of record as of June 15.

06:35 EDT Teleflex: Data published shows UroLift System as superior treatment to Rezum - Teleflex announced the publication of data from a study comparing patient experience of those treated with the UroLift System for benign prostatic hyperplasia to those who received the Rezum steam injection. Results highlighting early positive experience following treatment with the UroLift System were published in the Canadian Journal of Urology. Early post-operative results from the study showed positive differences for patients treated with the UroLift System compared to Rezum, including better sexual function outcomes, less interference in daily activities and higher patient satisfaction following the procedure. Additionally, results from the study found more than twice as many patients who received the UroLift System treatment reported being catheter free at day three (93%) compared to those who received Rezum (45%). At the 30-day mark, absolute symptom score was 45% better among patients treated with the UroLift System compared to those treated with Rezum. Results from the study also found that 83% of patients treated with the UroLift System reported they were satisfied with their treatment compared to 65% of patients treated with Rezum. Patients reported the treatment improved their urinary symptoms when treated with the UroLift System (97%) compared to those treated with Rezum (70%). Results also showed that patients in the UroLift System treatment group reported no interference with sports, and little interference with entertainment and community activities, while nearly half of the Rezum group patients reported that their procedure interfered with these activities. Additionally, patients that received the UroLift System reported better absolute scores for erectile function (61%) and ejaculatory function (33%) compared to Rezum patients.

06:32 EDT Merck's KEYTRUDA approved in China for treatment of ESCC - Merck announced that KEYTRUDA, Merck's anti-PD-1 therapy, has been approved by the National Medical Products Administration in China as monotherapy for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 as determined by a fully validated test, following failure of one prior line of systemic therapy. This new indication was granted full approval based on the overall survival findings from the global Phase 3 KEYNOTE-181 trial, including data from an extension of the global study in Chinese patients. With this new approval, KEYTRUDA is now approved for five indications across three different types of cancer in China, including as a first-line treatment for appropriate patients with advanced non-small cell lung cancer and as a second-line treatment for advanced melanoma. The U.S. FDA approval in July 2019 was based upon the global KEYNOTE-181 trial.

06:25 EDT Yintech Investment receives preliminary non-binding acquisition proposal - Yintech Investment announced that its board has received a preliminary non-binding proposal letter, dated June 22, from Mr. Wenbin Chen, co-founder, chairman of the board and CEO of Yintech, Mr. Ming Yan, co-founder and director of Yintech, and Ms. Ningfeng Chen, co-founder and director of Yintech, to acquire all of the outstanding ordinary shares of the Company that are not already held by the Buyer Group for a purchase price of $6.80 per American Depositary Share, or 34c per ordinary share, in cash. Yintech said in a release, "The Proposed Transaction, if completed, would result in the Company becoming a privately-held company owned by the Buyer Group, and the Company's ordinary share would be delisted from the NASDAQ Capital Market. The Company has formed a special committee of the Board, composed of Ms. Jue Yao, Mr. Yonghong Fan and Mr. Feng Li, each an independent and disinterest director, to consider the Proposal and the Proposed Transaction. The Company cautions that the Board has just received the Proposal Letter and has not made any decisions with respect to the Proposal Letter and the Proposed Transaction. There can be no assurance that the Buyer Group will make any definitive offer to the Company, that any definitive agreement relating to the Proposal Letter will be entered into between the Company and the Buyer Group, or that the Proposed Transaction or any other similar transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to this or any other transaction, except as required under applicable law."

06:20 EDT Cinedigm announces multi-film deal with Glass House Distribution - Cinedigm has announced a multi-film deal with Glass House Distribution starting with GUTTERBUG. Directed by Andrew Gibson, the award-winning film is scheduled to release on Digital and DVD on August 11. 2020. The partnership between Cinedigm and Glass House Distribution also includes the release of comedy CANADIAN STRAIN and thriller SAVIORS, both scheduled to release in September.

06:16 EDT Aurinia Pharmaceuticals completes enrollment in Phase 2/3 AUDREY trial - Aurinia Pharmaceuticals announced it has completed enrollment for the Phase 2/3 AUDREY clinical trial evaluating voclosporin ophthalmic solution for the potential treatment of dry eye syndrome, a chronic disease estimated to affect more than 16M people in the United States.

06:12 EDT Maxar Technologies awarded $23M contract by U.S. DHS - Maxar Technologies announced that it was selected by the U.S. Department of Homeland Security to develop an analytics system for characterizing and tracking the behavior of vehicles in multiple domains at scale and in near-real-time. The contract was awarded and is administered through the U.S. Department of the Interior and is valued at $23M with a five-year period of performance.

06:07 EDT China Distance Education forms committee to evaluate acquisition proposal - China Distance Education announced that its board of directors has formed a special committee consisting of Carol Yu and Annabelle Yu Long, each an independent director, to review and evaluate a previously-announced non-binding proposal that the board received on June 8 from Zhengdong Zhu, co-founder, chairman of the board and CEO of the company, Baohong Yin, co-founder of the company, deputy chairman of the board and the spouse of Zhu, and their affiliated entity, to acquire all of the outstanding ordinary shares of the company, including ordinary shares represented by american depositary shares, for $2.27 in cash per ordinary share, or $9.08 in cash per ADS. The special committee has retained Goulston & Storrs PC as its United States legal counsel in connection with its review and evaluation of the proposal.

06:02 EDT Tetraphase receives takeover proposal from La Jolla

05:42 EDT JinkoSolar to supply 60.9 MW for first industrial hybrid plant in Chile - JinkoSolar announced that it will supply 60.9 MW of bifacial modules for the first industrial hybrid plant in Chile. JinkoSolar said in a release, "The hybrid plant will be located about 10 kilometers outside the city of Calama in the Antofagasta Region and will consist of a 60.9 MW PV plant and a 90 MW wind farm. The hybrid PV plant, whose construction is expected to be finished in early 2021, will use about 154,710 JinkoSolar Bifacial panels to produce an estimated 184 GWh of electricity annually."

05:37 EDT Evelo Biosciences advances EDP1815 to Phase 2/3 TACTIC-E COVID-19 Trial - Evelo Biosciences announced that EDP1815 will be included in the TACTIC-E clinical trial. The trial will evaluate the safety and efficacy of certain experimental therapies in the prevention and treatment of life-threatening complications associated with COVID-19 in hospitalized patients at early stages of the disease. The trial's lead investigator is Dr. Joseph Cheriyan, Consultant Clinical Pharmacologist at Addenbrooke's Hospital in Cambridge, and is sponsored by Cambridge University Hospitals NHS Foundation Trust. Dr. Cheriyan said, "This is a critical time in the fight against COVID-19, and I am delighted that Cambridge is playing a key role in this. TACTIC-E will test the effectiveness of a number of experimental medicines in patients admitted to hospital, with a strong focus on identifying novel and clinically useful drugs early on. It will collect high quality data that can be used by our partner pharmaceutical companies to potentially seek approvals for widespread international use. We have opted to investigate EDP1815 in this trial given the tolerability and the modulation of multiple inflammatory pathways observed in a Phase 1b clinical trial for psoriasis. We look forward to evaluating EDP1815 as part of TACTIC-E." The company said in a release, "TACTIC-E is a Phase 2/3 randomised trial which will evaluate up to 469 patients per arm at Addenbrooke's Hospital and other leading UK clinical centres. The trial will enroll patients with COVID-19 who have identified risk factors for developing severe complications and are at risk of progression to the intensive care unit or death. Eligible patients will be randomised equally to either one of the active arms or treated with standard of care alone. Patients in arm 1 will be dosed with EDP1815 in addition to standard of care; patients in arm 2 will be dosed with a combination of ambrisentan and dapagliflozin in addition to standard of care; and patients in arm 3 will be treated with standard of care only. The primary outcome measure is a reduction in the number of patients who develop severe complications of organ failure, ventilation, or death. Secondary outcome measures include duration of stay in hospital, duration of oxygen therapy, changes in biomarkers associated with COVID-19 progression, and time to clinical improvement. Interim analyses will be performed over the course of the trial to evaluate results for signals of safety and efficacy. Interim data from the trial are anticipated during the fourth quarter of 2020. If the Phase 2/3 data are positive, Evelo plans to engage in discussions with global regulatory agencies to determine if the data support registration."

05:07 EDT PG&E completes initial stage of bankruptcy exit financing - Following the formal confirmation of the company's Plan of Reorganization by the United States Bankruptcy Court yesterday, PG&E and Pacific Gas and Electric announced today that PG&E has completed the initial stage of its bankruptcy exit financing contemplated in its Plan of Reorganization. As a result of its Chapter 11 proceedings, PG&E has been able to retire expensive high-coupon debt and replace it with lower cost debt, yielding significant annual savings for customers. These savings are estimated to be approximately $250 million annually. PG&E will reflect these savings in future customer bills later this year. "The primary purpose of our Chapter 11 filings was to address the billions of dollars in claims from victims of recent wildfires. We've been able to reach agreements with individual victims, public entities and others. This financing effort takes us one step closer to compensating victims for their losses," said Jason Wells, Chief Financial Officer of PG&E. The Chapter 11 proceedings also allowed us to refinance our debt which will result in real savings for customers starting this year, after we emerge from Chapter 11, consistent with our commitment to keep prices as low as possible for customers."