­Nevro to Participate in Citi Bank Head Shoulders Knees and Toes Conference Call Series on November 30th

On November 24, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that D. Keith Grossman, Nevro’s Chairman, CEO and President will participate in Citi Bank’s Head Shoulders Knees and Toes Conference Call Series on November 30, 2020 at 2pm ET (Press release, Nevro, NOV 24, 2020, View Source [SID1234571693]).

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Investors interested in listening to the call may do so by dialing (856) 344-9142 in the U.S., using Conference ID: 3168278. This dial-in information is available on the "Investors" section of the Company’s website at: www.nevro.com.

PreGene Closes $21 Million Financing for Fusion/Nano-Antibody Drugs

On November 24, 2020 PreGene, a Shenzhen biotech, reported that it closed a $21 million B financing as it looks forward to an IPO on the Hong Kong exchange. The funding was led by Haier Biomedical (Press release, PreGene, NOV 24, 2020, View Source [SID1234571741]). PreGene claims to have the world’s only fusion drug and nano-antibody drug biotechnology R&D platform. Founded in 2012, PreGene is also developing TCR-T, CAR-T and stem cell candidates. Its BCMA CAR-T candidate is approved to start clinical trials in China.

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Midatech Pharma PLC (“Midatech” or the “Company”) MTX110 Phase I Trial Results in DIPG and Preclinical Efficacy Data in Glioblastoma presented at 2020 Annual SNO Conference

On November 24, 2020 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), an R&D biotechnology company focused on improving the bio-delivery and biodistribution of medicines, reported that the latest research on MTX110 was presented by its collaborators at the recent annual meeting of the Society of Neuro-Oncology (SNO2020 Virtual Conference) (Press release, Midatech Pharma, NOV 24, 2020, View Source [SID1234571649]). Links to the Abstracts and Posters are provided below:

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PNOC015: An Open Label Single Arm Phase I/II Study of MTX110 Delivered by Convection-Enhanced Delivery (CED) in Patients with Diffuse Intrinsic Pontine Glioma (DIPG) Previously Treated with External Beam Radiation Therapy (ABSTRACT DDRE-21) – Lead Author: Dr Sabine Mueller, Pacific Pediatric Neuro-Oncology Consortium

The Abstract may be found at:

View Source

The Poster may be found at:

View Source

Efficacy of Soluble Panobinostat (MTX110) in Preclinical Models of Adult Glioblastoma (ABSTRACT TMOD-27) – Lead Author: Dr David Ashley, Preston Tisch Brain Tumor Centre, Duke University, Durham NC 27710

The Abstract may be found at:

View Source

The Poster may be found at:

View Source

Commenting, Steve Damment, EVP R&D of Midatech, said: "These presentations provide further information on the encouraging Phase I DIPG trial results recently announced by Midatech on 19 October 2020, and preclinical efficacy data supporting the potential utility of MTX110 for the significantly larger adult glioblastoma indication."

About MTX110

MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-β-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for DIPG (NCT03566199, NCT04264143) and recurrent medulloblastoma (NCT04315064), and preclinically for treatment of glioblastoma (SNO 2020 Abstract TMOD-27). MTX110 is delivered directly into and around the patient’s tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG tumour cells in in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient-derived DIPG cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).

Akebia Therapeutics to Participate in Piper Sandler 32nd Annual Virtual Healthcare Conference

On November 24, 2020 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported that it will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference (Press release, Akebia, NOV 24, 2020, View Source/news-releases/news-release-details/akebia-therapeutics-participate-piper-sandler-32nd-annual" target="_blank" title="View Source/news-releases/news-release-details/akebia-therapeutics-participate-piper-sandler-32nd-annual" rel="nofollow">View Source [SID1234571671]).

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John P. Butler, President and Chief Executive Officer, and David A. Spellman, Senior Vice President and Chief Financial Officer, will participate in virtual one-on-one meetings on Thursday, December 3, 2020.

A recording of Akebia’s conference presentation is available via the Piper Sandler conference site as well as on the Investors section of the Company’s website at View Source, from November 24 to December 3, 2020.

Medtronic Reports Second Quarter Fiscal 2021 Financial Results

On November 24, 2020 Medtronic plc (NYSE:MDT) reported financial results for its second quarter of fiscal year 2021, which ended October 30, 2020 (Press release, Medtronic, NOV 24, 2020, View Source [SID1234571694]).

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The company reported second quarter worldwide revenue of $7.647 billion, a decrease of 0.8 percent as reported and 1.5 percent on an organic basis, which adjusts for the $59 million benefit of foreign currency translation. Unless otherwise stated, all revenue growth rates in this press release are stated on an organic basis, which adjusts for the impact of foreign currency translation. There were no acquisitions made in the last year that had a significant impact on the company’s second quarter revenue growth.

As reported, second quarter GAAP net income and diluted earnings per share (EPS) were $489 million and $0.36, respectively. As detailed in the financial schedules included through the link at the end of this release, second quarter non-GAAP net income and non-GAAP diluted EPS were $1.380 billion and $1.02, respectively, both decreases of 22 percent. Adjusting for the negative 4 cent impact from foreign currency, second quarter non-GAAP diluted EPS decreased 19 percent.

Second quarter U.S. revenue of $4.054 billion represented 53 percent of company revenue and decreased 2 percent as reported and organic. Non-U.S. developed market revenue of $2.446 billion represented 32 percent of company revenue and increased 6 percent as reported and 1 percent organic. Emerging Markets revenue of $1.147 billion represented 15 percent of company revenue and decreased 9 percent as reported and 6 percent organic.

"We’re seeing a faster-than-expected recovery and approaching year-over-year growth. Our revenue growth is improving, our pipeline is advancing, and we’re gaining share in an increasing number of businesses. At the same time, we’re in the process of implementing our new operating model and augmenting our culture with a focus on market share and being bold," said Geoff Martha, Medtronic chief executive officer. "Despite the challenges posed by the pandemic, we’re well positioned to accelerate growth over the medium- and long-term as we continue investing in and progressing a number of opportunities, creating value for society and our shareholders."

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 second quarter revenue of $2.725 billion decreased 4.6 percent as reported and 5.5 percent organic. CVG’s revenue reflected a year-over-year decline in procedure volumes as a result of the COVID-19 pandemic; however, revenue did improve sequentially as procedures volumes continued to improve. CVG’s organic performance was impacted by low-single digit declines in CRHF, mid-teens decline in CSH, and low-single digit declines in APV.

Cardiac Rhythm & Heart Failure second quarter revenue of $1.426 billion was flat as reported and decreased 1.3 percent organic. Arrhythmia Management revenue, including implantable defibrillators (ICDs), Pacemakers, Implantable Diagnostics, and Cardiac Ablation Solutions declined in the low-single digits. This included mid-seventies growth in Leadless Pacemakers, and specifically mid-eighties growth in the United States, on the continued global adoption of the company’s Micra transcatheter pacing systems. Heart Failure declined low-single digits, as flat results in cardiac resynchronization therapy pacemakers (CRT-Ps) and mid-twenties declines in left ventricular assist devices (LVADs) were partially offset by mid-single digit growth in cardiac resynchronization therapy defibrillators (CRT-Ds) from the recent launch of Cobalt and Crome.

Coronary & Structural Heart second quarter revenue of $831 million decreased 13.0 percent as reported and 13.6 organic, reflecting high-twenties declines in drug-eluting stents (DES). The company experienced a slowdown in DES sales in China ahead of the national tender announcement in mid-October. In addition, the company recorded a $26 million reserve as a result of the tender. Outside of China, DES sales declined in the mid-teens. While transcatheter aortic valves (TAVR) declined high-single digits versus the prior year, the company estimates it held share in the third calendar quarter versus the prior quarter.

Aortic, Peripheral & Venous second quarter revenue of $468 million decreased 1.3 percent as reported and 1.9 percent organic. Aortic grew in the low-single digits, Peripheral declined in the low-single digits, and Venous declined in the high-single digits.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG second quarter revenue of $2.285 billion increased 6.7 percent as reported and 6.2 percent organic. MITG’s revenue reflected a year-over-year decline in procedure volumes offset by increased demand for COVID-19 related diagnostics and therapies. SI’s mid-single digit organic decline was offset by low-thirties organic growth in RGR.

Surgical Innovations second quarter revenue of $1.393 billion decreased 4.2 percent as reported and 4.9 percent organic. Advanced Surgical declined low-single digits, reflecting the decline of worldwide surgical procedures. General Surgery products declined in the high-single digits.

Respiratory, Gastrointestinal & Renal second quarter revenue of $893 million increased 29.8 percent as reported and 29.7 organic, reflecting the increased demand for Respiratory Interventions products. Respiratory & Patient Monitoring grew in the low-forties, with sales of ventilators increasing nearly four-fold, as the company increased production of its PB980 high-acuity ventilator to address global demand.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Cranial and Spinal Technologies, Specialty Therapies, and Neuromodulation divisions. RTG second quarter revenue of $2.063 billion decreased 2.3 percent as reported and 2.9 percent organic. RTG’s revenue reflected a year-over-year decline in procedure volumes as a result of the COVID-19 pandemic. RTG’s organic performance this quarter included mid-single-digit declines in Cranial and Spinal Technologies, flat results in Specialty Therapies, and low-single digit declines in Neuromodulation.

Cranial and Spinal Technologies second quarter revenue of $1.071 billion decreased 4.1 percent as reported and 4.6 organic, including low-single digit declines in Spine and high-single digit declines in Enabling Technology. Core Spine declined in the low-single digits globally and grew in the low-single digits in the US. China Orthopedics (Kanghui) grew in the high-single digits.

Specialty Therapies second quarter revenue of $581 million increased 1.0 percent as reported and 0.3 percent organic. ENT declined in the high-single digits, Neurovascular increased in the low-single digits, and Pelvic Health increased in the mid-single digits.

Neuromodulation second quarter revenue of $411 million decreased 2.1 percent as reported and 3.1 percent organic, including mid-single digit declines in Pain Therapies and low-single digit growth in DBS.
Diabetes Group
Diabetes Group second quarter revenue of $574 million decreased 3.7 percent as reported and 5.0 percent organic. Diabetes Group revenue performance was impacted by a delay in new patient starts on insulin pumps and continued competitive pressure. CGM grew in the mid-single digits.

Guidance
Given the uncertainty on near-term financial results caused by the COVID-19 pandemic, the company is not providing formal annual or quarterly financial guidance at this time.

Webcast Information
Medtronic will host a webcast today, November 24, at 8:00 a.m. EST (7:00 a.m. CST) to provide information about its businesses for the public, investors, 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.

Medtronic plans to report its fiscal year 2021 third and fourth quarter results on Tuesday, February 23, 2021 and Thursday, May 27, 2021, respectively, and its fiscal year 2022 first quarter results on August 24, 2021. Confirmation and additional details will be provided closer to the specific event.

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