On August 20, 2019 Delcath Systems, Inc. ("Delcath," the "Company", "we", "our" or "us" (OTCQB: DCTH) reported that it has closed on its previously announced private placement with gross proceeds of $9.5 million at a combined price of $1,000 per Unit (Press release, Delcath Systems, AUG 20, 2019, View Source [SID1234538880]). Each Unit consists of one preferred share initially convertible into 16,667 shares of common stock at an initial conversion price of $0.06 per share and a common stock purchase warrant. Each whole warrant entitles the holder to purchase one share of common stock at an initial exercise price of $0.06 for a period of five years from the date of the Company’s anticipated reverse stock split. The Company has now raised a total of $29.5 million since July 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The offering is being led by fundamental healthcare investors, including Rosalind Advisors and Altium Capital.

Commenting on the announcement, Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath stated, "With this transaction completed, we have a cash runway beyond top line data, a clean capitalization table and the foundation for a possible path to NASDAQ listing. Looking forward, we are positioned for success through multiple value inflection points including full enrollment, top line data and NDA filing – targeted for Q4 2019, 1H 2020 and Q4 2020, respectively, in our registration trial for the treatment of metastatic Ocular Melanoma (mOM). mOM is a devastating disease of high unmet-need for which there is no approved standard-of-care in the United States and for which the Company has orphan drug designation."

Dr. Simpson added, "the management team has laid the foundation for a leading interventional oncology platform company and now has the resources, capital structure and operational resources to move forward its long-term priorities and growth plans, to maximize shareholder value."

The recapitalization enables Delcath to pursue its business plan to:

Develop therapies for cancers of the liver with high unmet medical need and no established standards of care, addressing a multi-billion-dollar opportunity in the United States and Europe;

Expand development of our platform to other indications, chemotherapies and organs; and;

Support our commercial partner medac in Europe (where CHEMOSTAT is approved) to maximize the opportunities set out in our December 2018 commercialization agreement.

The company recently announced the addition of John R. Sylvester to its Board of Directors. Mr. Sylvester is currently Chief Commercial Officer at BTG PLC, an international specialist healthcare company that develops and commercializes products targeting critical care, cancer and other disorders. The quality of BTG’s interventional medicine business played an integral part in its sale to Boston Scientific for $4.2 billion. The Company intends to leverage John’s expertise and experience in the commercialization of new medical technologies as Delcath prepares to enter US and ex-US markets.

Dr. Simpson concluded by stating, "I would like to thank the investors who took the time to assess this incredible opportunity and as a result have recognized the substantial value of Delcath’s assets, technology and clinical programs. Management and the Board are excited to work with our team of clinicians and key opinion leaders to make Melphalan/HDS available as a treatment option to improve patients’ lives and outcomes."

Roth Capital Partners acted as the sole placement agent for the offering. After the placement agent fees and estimated offering expenses payable by the Company, the Company has received net proceeds of approximately $8.6 million. The offering closed on Aug 19, 2019.

The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended or applicable under state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company has agreed to file a resale registration statement on Form S-1 with the Securities and Exchange Commission by August 21, 2019 for purposes of registering the resale of the shares of common stock issuable upon conversion of the preferred shares and upon exercise of the warrants issued in the private placement.

This notice does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On August 20, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that a license agreement has been reached with Biotheus Inc. ("Biotheus"), a privately held Chinese company based in Zhuhai, Guangdong, China (Press release, Alligator Bioscience, AUG 20, 2019, View Source [SID1234538879]). Under the license agreement, Alligator has granted Biotheus rights in Greater China (including Republic of China, Hongkong, Taiwan and Macau) to an antibody from ALLIGATOR-GOLD for the creation of up to three bispecific molecules. The license agreement includes an option for expanding the license to covering global rights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The license agreement includes an upfront of USD 1 million where Alligator receives USD 0.5 million upon signing and USD 0.5 million after 6 months of scientific-technical evaluation. Under the agreement Alligator is eligible to receive upfront, milestones and option fees of up to a total of approximately USD 142 million. This sum includes upfront and development milestones amounting to a total of approx. USD 52 million, global option fees up to a total of USD 90 million, plus royalties on future sales and share of sub-license revenue.

"This agreement is a great recognition of our antibody library and our proven expertise in generating high affinity antibodies against TNFR family members, and this collaboration with an up and coming Chinese biotech firm like Biotheus gives us an entrance to the fast advancing life science market in China", said Per Norlén, CEO Alligator Bioscience.

The Tumor Necrosis Factor Receptor super family (TNFR-SF) is a family of related receptors, sharing sequence homology. Several Alligator pipeline programs interact with members of the TNFR super family.

For further information, please contact:
Cecilia Hofvander, Director IR & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact persons set out above, at 4:35 p.m. CEST on August 20, 2019.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported that an abstract on the company’s CS1001-201 trial has been submitted to the upcoming 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, CStone Pharmaceauticals, AUG 20, 2019, View Source [SID1234538864]). This will mark the first release of CS1001-201 clinical study data since the trial began.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CS1001 is an investigational anti-PD-L1 monoclonal antibody developed by CStone. CS1001 is currently being evaluated in multiple clinical trials in China, including one multi-arm Phase I study, two registrational Phase II studies, and three Phase III clinical studies. Based on previously released data, CS1001 has shown good overall safety and tolerability, and demonstrated promising clinical utility for combination therapy in various tumor types.

The CS1001-201 trial reported in the abstract is a single-arm, multi-center Phase II clinical study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of CS1001 monotherapy in relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (rr-ENKTL). The primary endpoint of the study is objective response rate (ORR).

ENKTL is a subtype of mature T-cell and NK-cell lymphoma. With its particular geographic predilection, the incidence rate of ENKTL is significantly higher in Asia than it is in Europe or North America. There are around 5,300 new ENKTL cases in China each year, which accounts for approximately 6% of all lymphoma incidences in the country. Approximately 50% of those ENKTL cases progress to rr-ENKTL. ENKTL is an aggressive malignancy with a dismal prognosis. Currently, there is no standard treatment for ENKTL patients in whom the L-asparaginase-based combination therapy has not been effective. CS1001-201 is the first clinical trial investigating an anti-PD-L1 antibody in rr-ENKTL patients, and durable anti-tumor activity has already been observed in the trial.

The abstract submitted to the 2019 ASH (Free ASH Whitepaper) Annual Meeting, if accepted, will highlight the safety and efficacy data from the CS1001-201 Phase II study in rr-ENKTL patients, and it will be the first report of the CS1001-201 trial and the fourth data update on CS1001 at a major scientific conference in 2019, following the ASCO (Free ASCO Whitepaper) Annual Meeting, the ESMO (Free ESMO Whitepaper) Annual Congress, and the CSCO Annual Meeting.

About CS1001

CS1001 is an investigational anti-PD-L1 monoclonal antibody being developed by CStone. Authorized by the U.S.-based Ligand Corporation, CS1001 was generated by the OMT transgenic animal platform, which can produce fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can potentially reduce the risk of immunogenicity and toxicities in patients, a unique advantage over similar drugs.

CS1001 has completed a Phase I dose-escalation study in China and has demonstrated promising anti-tumor activity and tolerability.

CS1001 is currently being evaluated in multiple clinical trials including a bridging phase I trial in the USA, a multi-arm phase Ib dose-expansion study, two pivotal Phase II studies and three Phase III studies in China in various cancer types.