On August 20, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic", stock ticker: XYNO), a clinical stage US-China oncology drug development company, reported that Xynomic Research Institute ("XRI") has successfully designed a series of potent RET kinase inhibitors by computer-assisted drug design (Press release, Xynomic Pharmaceuticals, AUG 20, 2019, View Source [SID1234538875]). Rearranged during transfection ("RET") is a receptor tyrosine kinase that activates multiple downstream pathways involved in cell proliferation and survival. RET fusions are implicated in several cancers including non-small cell lung cancer, papillary thyroid cancer and medullary thyroid cancer.

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Xynomic’s RET kinase inhibitors are a class of acetylene derivatives with novel and stable structures. Preliminary activity tests showed that they exhibited outstanding selectivity and inhibitory activity against TT tumor cells, and some compounds were identified as having submicromolar IC50 values in the mid- to low-nanomolar range. Further structure-activity relationship studies are currently underway to quickly screen and obtain lead compounds.

"XRI focuses on research and development of innovative oncology drug candidates. We have recently upgraded our infrastructure and equipment and hired additional scientists. We believe that we are now well positioned to fully leverage XRI’s capacity to efficiently design and synthesize cutting edge molecules." Mr. Y. Mark Xu, Chairman and CEO of Xynomic commented.

XRI has already filed global patents for internally discovered pre-clinical drug candidates XP-103 and XP-104. XP-103 is a dual inhibitor of tropomyosin receptor kinases and Fra-1 enzymes currently in the lead optimization stage. XP-104 is a RET inhibitor being investigated for use against multiple tumors, especially tumors that have developed resistance against other targeted therapies. Animal studies of XP-104 is expected to start soon.

On August 20, 2019 Lannett Company, Inc. (NYSE: LCI) reported that it will report financial results for its fiscal 2019 fourth quarter and full year on Tuesday, August 27, 2019, after the market closes (Press release, Lannett, AUG 20, 2019, https://www.prnewswire.com/news-releases/lannett-to-report-fiscal-2019-fourth-quarter-full-year-financial-results-host-conference-call-on-tuesday-august-27-300903891.html [SID1234538892]). Lannett management will host a conference call that same afternoon at 4:30 p.m. Eastern Time to review the company’s performance and answer questions.

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The conference call will be available to interested parties by dialing 800-447-0521 from the U.S. or Canada, or 847-413-3238 from international locations, passcode 48926565. The call will be broadcast via the Internet at www.Lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

On August 20, 2019 Medtronic plc (NYSE:MDT) reported financial results for its first quarter of fiscal year 2020, which ended July 26, 2019 (Press release, Medtronic, AUG 20, 2019, View Source;p=RssLanding&cat=news&id=2406815 [SID1234538876]).

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The company reported first quarter worldwide revenue of $7.493 billion, an increase of 1.5 percent as reported or 3.5 percent on a constant currency basis, which adjusts for a $146 million negative impact from foreign currency. As reported, first quarter GAAP net income and diluted EPS were $864 million and $0.64, respectively. As detailed in the financial schedules included through the link at the end of this release, first quarter non-GAAP net income and non-GAAP diluted EPS were $1.703 billion and $1.26, respectively, increases of 6 percent and 8 percent, respectively. Adjusting for a negative 2 cent impact from foreign currency, first quarter non-GAAP diluted EPS increased 9 percent.

First quarter U.S. revenue of $3.918 billion represented 52 percent of company revenue and increased 1.4 percent as reported. Non-U.S. developed market revenue of $2.377 billion represented 32 percent of company revenue and decreased 1.2 percent as reported and increased 2.6 percent on a constant currency basis. Emerging market revenue of $1.198 billion represented 16 percent of company revenue and increased 7.5 percent as reported and 12.5 percent on a constant currency basis.

"Medtronic had a solid first quarter, delivering revenue growth, operating margin expansion, and adjusted EPS growth all ahead of expectations," said Omar Ishrak, Medtronic chairman and chief executive officer. "It’s a good start to our fiscal year."

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic, Peripheral & Venous (APV) divisions. CVG first quarter revenue of $2.790 billion decreased 0.7 percent as reported and increased 1.4 percent on a constant currency basis. CVG’s revenue performance was driven by mid-single digit growth in CSH and low-single digit growth in APV, offset by low-single digit declines in CRHF, all on a constant currency basis.

Cardiac Rhythm & Heart Failure first quarter revenue of $1.382 billion decreased 3.1 percent as reported or 1.2 percent on a constant currency basis. Arrhythmia Management grew in the mid-single digits on a constant currency basis, driven by mid-single digit growth in Pacemakers, including mid-twenties growth of the Micra transcatheter pacing system, as well as mid-thirties growth of the TYRX absorbable antibacterial envelope, high-single digit growth of the Reveal LINQ insertable cardiac monitoring system, and high-single digit growth in AF Solutions, all on a constant currency basis. Arrhythmia Management growth was offset by low-double digit declines in Heart Failure, including high-forties declines in sales of left ventricular assist devices (LVADs), both on a constant currency basis.

Coronary & Structural Heart first quarter revenue of $941 million increased 2.6 percent as reported or 5.2 percent on a constant currency basis, led by mid-teens constant currency growth in sales of transcatheter aortic valves, reflecting the clinical benefits of the CoreValve Evolut PRO platform. Transcatheter aortic valve growth was offset by low-single digit declines in drug-eluting stents, in-line with the market.

Aortic, Peripheral & Venous first quarter revenue of $467 million decreased 0.2 percent as reported or increased 1.7 percent on a constant currency basis. Venous grew in the high-single digits on a constant currency basis on strong VenaSeal and ClosureFast system growth. Aortic grew in the mid-single digits on a constant currency basis, reflecting strong demand for the Valiant Navion thoracic stent graft system. Peripheral declined in the high-single digits on a constant currency basis, as low-thirties constant currency declines in drug-coated balloons offset growth in other core product segments.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG first quarter revenue of $2.100 billion increased 2.3 percent as reported or 4.8 percent on a constant currency basis. MITG’s revenue performance was driven by balanced growth across both divisions, with mid-single digit constant currency growth in both SI and RGR.

Surgical Innovations first quarter revenue of $1.417 billion increased 1.4 percent as reported or 4.2 percent on a constant currency basis, driven by strong contributions from Advanced Energy and Advanced Stapling. Advanced Energy grew in the high-single digits on continued strength in sales of LigaSure vessel sealing instruments, including the Ligasure Exact dissector, and the Valleylab FT10 energy platform. Advanced Stapling grew in the mid-single digits on a constant currency basis, driven by strong demand for Tri-Staple 2.0 endo stapling specialty reloads and the EEA circular stapler with Tri-Staple technology for colorectal procedures.

Respiratory, Gastrointestinal & Renal first quarter revenue of $683 million increased 4.3 percent as reported or 6.1 percent on a constant currency basis. Respiratory and Patient Monitoring grew in the mid-single digits on a constant currency basis on strong sales of Nellcor pulse oximetry, Microstream capnography, and INVOS cerebral oximetry systems, Puritan Bennett 980 ventilators, and McGRATH MAC video laryngoscopes. GI Solutions grew in the low-double digits on a constant currency basis, with solid growth in PillCam systems, Emprint ablation systems, and Beacon endoscopic ultrasound products. Renal Care Solutions grew mid-single digits on a constant currency basis on strength in renal access products.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Brain Therapies, Spine, Specialty Therapies, and Pain Therapies divisions. RTG first quarter revenue of $2.012 billion increased 3.2 percent as reported or 4.6 percent on a constant currency basis. RTG’s revenue performance was driven by low-double digit growth in Brain Therapies, mid-single digit growth in Specialty Therapies, and low-single digit growth in Spine, offset by mid-single digit declines in Pain Therapies, all on a constant currency basis.

Brain Therapies first quarter revenue of $740 million increased 9.8 percent as reported or 11.4 percent on a constant currency basis, driven by mid-teens constant currency growth in Neurovascular and low-double digit constant currency growth in Neurosurgery. Neurovascular results were broad-based, with high-teens growth in stent retrievers and flow diversion and low-double digit growth in coils, all on a constant currency basis. In addition, the company is seeing rapid adoption of the Riptide aspiration system and React aspiration catheters. Neurosurgery was led by strong, double digit growth of StealthStation S8 surgical navigation systems, O-arm surgical imaging systems, and Mazor X robotic guidance systems.

Spine first quarter revenue of $658 million increased 0.9 percent as reported or 2.0 percent on a constant currency basis. When combined with the company’s sales of enabling technology used in spine surgeries, including robotics, navigation, imaging, and powered surgical instruments that are recognized in the Brain Therapies division, global Spine revenue and U.S. Core Spine revenue both grew in the mid-single digits on a constant currency basis. Cervical spine products grew mid-single digits on a constant currency basis, driven by the continued launch of the Infinity OCT system and solid growth of the Prestige LP cervical disc system. Sales of Infuse bone graft grew in the low-double digits on a constant currency basis.

Specialty Therapies first quarter revenue of $322 million increased 4.2 percent as reported or 5.5 percent on a constant currency basis. ENT grew in the mid-single digits on a constant currency basis, driven by capital equipment sales of the StealthStation ENT surgical navigation system and intraoperative NIM nerve monitoring systems. Pelvic Health grew in the mid-single digits on the strength of InterStim II system sales.

Pain Therapies first quarter revenue of $292 million decreased 7.0 percent as reported or 6.1 percent on a constant currency basis. Pain Stimulation declined in the low-double digits, reflecting channel destocking and the overall slowdown of the spinal cord stimulation market.
Diabetes Group
Diabetes Group first quarter revenue of $592 million increased 3.5 percent as reported or 5.4 percent on a constant currency basis. Diabetes Group revenue performance was led by international markets, which grew 15.3 percent as reported or 19.8 percent on a constant currency basis, driven by the ongoing launch of the MiniMed 670G hybrid closed loop insulin pump system with the Guardian Sensor 3.

Sales of integrated continuous glucose monitoring (CGM) sensors grew in the mid-teens on a constant currency basis, driven by global adoption of sensor-augmented insulin pump systems and the resulting strong sensor attachment rates. The Diabetes Group also continued to see strong adoption of the Guardian Connect Smart CGM system, which grew in the high-eighties.

Guidance
The company today reiterated its revenue growth guidance and raised its EPS guidance for fiscal year 2020.

The company continues to expect revenue growth in its fiscal year 2020 to approximate 4.0 percent on an organic basis. If current exchange rates hold, revenue growth in fiscal year 2020 would be negatively affected by 0.8 to 1.2 percent.

The company increased its fiscal year 2020 diluted non-GAAP EPS guidance from the prior range of $5.44 to $5.50 to the new range of $5.54 to $5.60, including an estimated 10 cent negative impact from foreign exchange based on current rates.

"As a result of our first quarter outperformance and confidence in our outlook, we are raising our full year EPS guidance," said Ishrak. "We’re excited about what lies ahead, as we expect the investments we’ve made in our pipeline to begin to pay off with multiple pipeline catalysts, accelerating revenue growth, and value creation for our shareholders."

Webcast Information
Medtronic will host a webcast today, August 20, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on its Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules
To view the first quarter financial schedules and non-GAAP reconciliations, click here. To view the first quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.

On August 19, 2019 Mateon Therapeutics, Inc. (OTCQB:MATN) ("Mateon") and PointR Data Inc. (PointR), a privately-held, developer of high performance cluster computer and artificial intelligence company, reported that they have entered into a definitive agreement with respect to a merger, creating a publicly traded artificial intelligence ("AI") driven immuno-oncology company with a robust pipeline of first in class TGF-β immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma (Press release, Mateon Therapeutics, AUG 19, 2019, View Source [SID1234538861]).

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"We believe that the merger of Mateon and PointR will create a combined company that can generate shareholder value through a promising pipeline of next generation immunotherapies leveraging high performance, personalized and secure cluster computer for AI driven drug development and personalized healthcare deliveries," said Vuong Trieu, Ph.D., Chairman and Chief Executive Officer of Mateon. "This is culmination of over a year of working together on disruptive technologies for drug development and healthcare."

"We are thrilled at the opportunity of vertically integrating AI and drug development capabilities under one roof. We expect to quickly identify promising new therapeutic opportunities for various diseases delivering compelling business value," said Saran Saund, PointR’s Chief Executive Officer. "The prospect of interdisciplinary teams from biotech and technology sectors can significantly accelerate drug candidates towards the clinic while expanding our proprietary datasets."

"The integration of AI and machine learning algorithms in new drug discovery and lead optimization, design of biomarker-driven clinical studies as well as identification of biomarker-enriched patient populations most likely to respond to new anti-cancer drug candidates are potentially paradigm-shifting initiatives with a very high scientific merit. AI-based cognitive technologies have the potential to streamline our clinical development strategy for the portfolio drug candidates, including our lead compound OT101, by amplifying our knowledge and understanding of the target cancers, their biology as well as structural and pharmacologic characteristics of the lead compounds," said Dr. Fatih Uckun, MD, PhD, the Chief Medical Officer of Mateon. "Furthermore, the combined use of AI and the Blockchain technology supported by the PointR AI computing platform has a very high impact potential for better cancer care and especially patient-tailored cancer treatments," he added. Dr. Uckun explained: "Blockchain technology-powered clinical development platforms for the anti-cancer drug candidates in our pipeline, including our lead compound OT101 could (i) expedite multi-stakeholder collaboration via optimized peer-to-peer data sharing for success of R&D efforts aimed at a cure for difficult-to-treat forms of cancer, (ii) amplify data management capabilities that are critical for the clinical development of the most promising drug candidates, and (iii) enable rapid identification of best clinical study sites and investigators as well as optimized clinical protocol designs to ensure high quality clinical trials with streamlined feasibility checks and very short study start-up and rapid completion times.

Merger Terms

Under the terms of the merger agreement, PointR will be merged into and become a wholly owned subsidiary of Mateon. Holders of PointR common stock prior to the merger will be entitled to $15,000,000 payable in shares of Mateon common stock, calculated at of $0.18 per share. The merger agreement also provides for two additional tranches of merger consideration based on: (1) PointR’s achievement of proof of concept and (2) licensing deal for AI based asset for minimum of $100 million in life-time license fees of which at least $10 million has been received. Each tranche is for $7,500,000 in value of additional Mateon common stock, based on the market price at the time of payment, subject to a minimum value of $0.18 per share.

The merger is subject to customary conditions to closing. In addition, Mateon’s obligation to close is conditioned on PointR providing audited financial statements that would be required for Mateon to comply with the SEC’s filing requirements. PointR’s obligation to close is conditioned on Mateon raising a minimum of $10 million in an equity financing transaction or $5 million in a commercial agreement. In addition, PointR’s obligation is conditioned upon Mateon to grant a license to allow the former shareholders of PointR to use elements of the technology in fields outside of pharmaceutical development. Mateon and PointR intend to actively seek additional capital to support the combined business, no additional equity financing or commercial agreement is in place at this time. The merger is not expected to close until such financing is secured.

On August 19, 2019 Spherix Incorporated (Nasdaq: SPEX) reported that it has filed a Preliminary Proxy Statement with the Securities and Exchange Commission and announced a Special Meeting of Stockholders related to approving various items related to the proposed and previously announced acquisition of substantially all of the assets of CBM BioPharma, Inc. ("CBM") (Press release, Spherix, AUG 19, 2019, View Source [SID1234538984]).

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The acquisition of the CBM assets constitutes another step in Spherix’s continued transformation into an innovative pharmaceutical company with pioneering drugs and treatments focused on the development and commercialization of oncology therapeutics. CBM is a privately held pharmaceutical company with exclusive drug development rights from world renowned partners like Wake Forest University and University of Texas. CBM has a team of leading drug development scientists who will be joining the Spherix Advisory Board. The CBM platform focuses on the treatment of numerous cancers, including Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) and pancreatic cancer.

Spherix recently acquired a 20% ownership interest in CBM. That 20% ownership stake puts Spherix in a position to benefit from any dividend distribution made by CBM from any potential sale of Spherix stock that CBM receives from the transaction.

Mr. Anthony Hayes, CEO of Spherix stated, "We are moving methodically and expeditiously to complete this transformative merger, wherein we will become a diversified biopharmaceutical company with a compelling portfolio of potential compounds to develop and commercialize. The deal is structured in a way as to minimize the cash outlay and create a structure that we hope will allow Spherix to be paid back a portion of its CBM investment. As a 20% owner of CBM, Spherix will be in a position to receive 20% of all dividends that CBM may make if CBM sells any portion of its Spherix stock. These dividends can be used to further advance the newly purchased CBM technology, without any additional dilution to shareholders."