On February 22, 2021 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing its Nano-Pulse Stimulation (NPS) technology, reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Pulse Biosciences, FEB 22, 2021, View Source [SID1234575381]).

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Recent Highlights

Received U.S. Food and Drug Administration (FDA) clearance for the CellFX System for dermatologic procedures requiring ablation and resurfacing of the skin
Received CE mark approval for the CellFX System
Initiated the CellFX System Controlled Launch program in the U.S. and Europe, including system implementations and completion of the first procedures performed by participating Key Opinion Leader (KOL) aesthetic dermatologists
Continued preparation to make an FDA 510(k) submission for a sebaceous hyperplasia (SH) specific indication for the CellFX System as early as the end of the first quarter of 2021
Enrolled and treated the first patients in an IDE pivotal comparison study to evaluate the treatment of cutaneous non-genital warts using the CellFX System
"Our diligent efforts throughout 2020 resulted in regulatory clearances for the CellFX System in the U.S. and Europe. We believe these achievements highlight the safety and efficacy of our CellFX System for use in aesthetic dermatology. Along with our clinical investigators, we have built a strong foundation from which we intend to expand CellFX System indications for use, first in aesthetic dermatology and subsequently for other applications over time, as we execute on our stepwise regulatory strategy," said Darrin Uecker, President and CEO of Pulse Biosciences. "The detailed and thoughtful preparation by our team has enabled the immediate implementation of our Controlled Launch program of the CellFX System integrated with CellFX CloudConnect services. In both the U.S. and in Europe, we now have KOLs performing CellFX procedures. This measured approach is our top focus in 2021 and will lay the groundwork for long term adoption of the CellFX System with CellFX CloudConnect and growth for Pulse Biosciences."

Fourth Quarter 2020 Results

Cash, cash equivalents and investments totaled $20.5 million as of December 31, 2020, compared to $29.6 million as of September 30, 2020. Cash used in the fourth quarter of 2020 totaled $9.1 million. Excluding net proceeds received in our June 2020 rights offering, cash use for the full year ended December 31, 2020 totaled $34.6 million, compared to $34.2 million for the full year 2019.

Operating expenses for the three months ended December 31, 2020 were $13.8 million, compared to $13.9 million for the prior year period. Fourth quarter 2020 operating expenses included stock-based compensation expense of $2.4 million, compared to $3.5 million in the fourth quarter of 2019.

Operating expenses for the twelve months ended December 31, 2020 were $50.0 million, compared to $48.0 million for the prior year period. Stock-based compensation expense for the twelve months ended December 31, 2020 was $10.1 million, compared to $11.3 million in the prior year period. The increase in operating expenses was primarily driven by the expansion of operational infrastructure and increased headcount to support preparations for commercialization.

Net loss for the three months ended December 31, 2020 was ($13.8) million in line with the same ($13.8) million for the three months ended December 31, 2019. Net loss for the twelve months ended December 31, 2020 was ($49.9) million, compared to ($47.0) million for the twelve months ended December 31, 2019.

Impact of COVID-19

The COVID-19 pandemic had minimal impact on our operations in the fourth quarter of 2020. Product development, execution of clinical trials, regulatory timelines and controlled commercial launch have not been materially affected at this time but due to the uncertain scope and duration of the pandemic, future impact to our operations and financial results cannot be reasonably estimated.

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, February 22, 2021 beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-705-6003 for domestic callers or 1-201-493-6725 for international callers. A live and recorded webcast of the event will be available at View Source

On February 22, 2021 Cell therapy company ONK Therapeutics and blood cancer charity Anthony Nolan reported that they have entered into a collaboration to facilitate the development of the next-generation natural killer (NK) cell therapies to improve the lives of patients with hematological malignancies and solid tumors (Press release, ONK Therapeutics, FEB 22, 2021, View Source [SID1234575380]).

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Anthony Nolan Cell & Gene Therapy Services will provide a consistent supply of umbilical cord blood and cord-derived NK cells as a choice of starting material for both ONK Therapeutics’ research activities and continued process development work. This source material is scalable and ethically-sourced from consenting donors.

The parties bring together their extensive experience in cell sourcing, cell processing, translational research, understanding of the tumor microenvironment, and exploration of NK cells as a foundation for cellular immunotherapy. In doing so they aim to expedite the development of much-needed new lifesaving cell therapies for patients with a broad range of cancers.

Diana Hernandez, Head of Immunotherapy at the Anthony Nolan Research Institute says: "Our innovative partnership with ONK Therapeutics will serve to accelerate vital research and development into hematological and solid cancer treatments. We see this as an exciting opportunity which will ultimately lead to better treatments, improving the lives of many more cancer patients."

Chris Nowers, CEO of ONK Therapeutics says: "Anthony Nolan has a rich heritage in stem cell therapy research, including an enviable understanding of the biology of NK Cells and their processing. We look forward to continuing to partner with their team and to benefiting from their extensive know-how as we drive our programs towards clinical trials and beyond."

On February 22, 2021 NantHealth, Inc. (NASDAQ-GS: NH), a provider of enterprise solutions that help businesses transform complex data into actionable insights, reported that it will report financial results for its 2020 fourth quarter and full year on Thursday, February 25, 2021, after market close (Press release, NantHealth, FEB 22, 2021, View Source [SID1234575379]). NantHealth management will host a conference call that same day at 1:30 p.m. PT (4:30 p.m. ET) to review the company’s performance.

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The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 9786375. The call will be broadcast via the Internet at www.nanthealth.com.

On February 22, 2021 Ipsen (Euronext: IPN; ADR: IPSEY) reported a total of 9 abstracts presenting new data with a focus in NETs (Press release, Ipsen, FEB 22, 2021, View Source [SID1234575378]).1-10 These include data from the Phase II CLARINET FORTE study and data on the use of independent administration of lanreotide autogel to be presented at the ENETS Conference, taking place virtually 25-27 February 2021.1-3

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Updated data from the CLARINET FORTE study were presented including additional quality of life (QoL) data showcasing assessments of patients’ perceived QoL during the treatment period of the study.1 QoL was assessed using three validated questionnaires covering the severity of problems associated with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D-5L), as well as questionnaires specific to patients with cancer (EORTC QLQ-C30) and NETs (QLQ‑GINET.21).1 Results from these measurements suggest no deterioration of QoL with no substantial deviation from baseline prior to treatment.1 Additional pharmacokinetic (PK) analyses of the increased dosing regimen showed that PK increased in a proportional manner and no increase in rates of glycoregulation, cholelithiasis or hypertension in patients with increased lanreotide autogel exposure was observed.2 With confirmation of the PK data together with the substantial period of QoL preservation, data from the CLARINET FORTE study could represent a potentially meaningful treatment option for a population of patients with high unmet needs.1-2

"The new findings from the CLARINET FORTE trial highlighted that QoL remained stable throughout the study in patients who were enrolled with progressive disease and who were receiving twice the frequency of injections compared with their pre-study regimen", said Professor Marianne Pavel, Friedrich-Alexander University of Erlangen, Germany, Senior Physician and Chair of Endocrinology, and principal investigator of the study. "This is an important new measure as it reflects the patients’ perceptions of their own current overall health and means that patients with progressive NETs may be able to remain on a more tolerable first-line standard of care for longer with no new safety signals or quality of life deterioration."

Among the Ipsen data presented at ENETS 2021 is the presentation of findings from a study into the potential cost savings associated with increased uptake of independent administration of long-acting somatostatin analogues (SSAs) for the treatment of gastroenteropancreatic NETs (GEP-NETs) within the UK’s National Healthcare Service (NHS).3 In the UK, lanreotide autogel is approved for independent injection at home by the patient or a partner*.11 Health-economic modeling suggests that when a patient with GEP-NETs treated with octreotide long-acting release (LAR) transition to lanreotide autogel administered via independent injection, an average of 14.5 nurse contacts, including four hospital visits, could potentially be avoided every year as well as potential overall expenses per patient being lowered by 16.4% equating to £2,458 saved per year. At a population level, the increase in patients independently injecting SSAs, from 12.6% (pre-COVID) to 24.5% (during COVID), may have reduced the annual overall healthcare expenditure for the NHS from £53.4M to £52.9M.3

"The effective remote management of patients has never been more critical. As a chronic condition, patients living with NETs require long-term solutions which provide continuity of treatment and flexibility. Home administration of lanreotide autogel provides patients living with NETs the independence to manage their own treatment and can ease the pressure on frontline healthcare professionals, reducing hospital visits and potentially the risk of COVID-19 for patients," said Lilian Cortez, author and GI specialist pharmacist at the The Royal Marsden NHS Foundation Trust, UK. "The potential benefits identified in this study should be considered alongside patient experience in evaluating pandemic-enforced practices that may be beneficial to adopt long-term."

Ipsen also unveiled details from multiple studies highlighting a data-driven vision of patient-centricity, which show how mining the wealth of data generated from a drug’s discovery to real-world use after regulatory approval can unlock insights into the epidemiology and clinical features of NETs. These include a retrospective study leveraging data from five years of electronic health records to increase understanding of NETs and help to identify new therapeutic strategies; and results from the Phase III RAISE study investigating the use of deep learning models and dissociated response to predict early treatment efficacy in patients with NETs.4,5

"True patient-centricity requires an analytical, insights-driven mindset and at Ipsen we are pushing the boundaries to bring new data to best serve patients and their families, and generate pharmacoeconomic measures of Health Systems," said Prof. Dr. Steven Hildemann, Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs and Patient Safety, Ipsen. "Ipsen remains a committed partner and leader in the NET landscape and our presence at ENETS showcases how we are taking strides in making tangible differences for patients living with NETs. As a company, we continue to champion the empowerment of patients across the treatment pathway."

About NETs

Neuroendocrine tumors, or NETs, are a group of uncommon tumors that develop in the cells of the neuroendocrine system, throughout the body.12,13 NETs occur in both men and women, in general aged 50 to 60 years old, although they can affect anyone of any age.14

The three licensed areas where NETs are found in the body are the gastrointestinal tract, the pancreas and the lungs.15

Gastrointestinal NETs (GI-NETs) are found in the gastrointestinal tract or digestive system and are the most common type of NETs.15
Pancreatic NETs (panNETs) are formed in the islet cells of the pancreas and include several uncommon types of NETs.15
Lung NETs are less common than other types, accounting for about one quarter of NETs.15

The symptoms of NETs are often not distinct and difficult to identify, and can sometimes take between five to seven years to fully diagnose.16 The number of people being newly diagnosed with NETs overall is believed to be rising.17 This is mainly due to increased awareness of the condition and diagnostic testing.17 NETs are now the fastest growing class of cancers worldwide, accounting for around 2% of all cancers at any time.17

About CLARINET FORTE

CLARINET FORTE was a prospective single-arm, open-label, exploratory, international Phase II study to explore the efficacy and safety of an increased lanreotide autogel dosing frequency (120 mg every 14 days) in patients with metastatic or locally advanced unresectable pancreatic NETs or midgut NETs, with centrally-accessed progression within the last two years while on a standard lanreotide autogel regimen (120 mg every 28 days) for 24 weeks or more.18 Initial efficacy and safety data from the CLARINET FORTE study were presented at the 2020 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which took place on 19-21 September 2020.

About Somatuline Autogel (lanreotide)

Somatuline Autogel/Depot is made of the active substance lanreotide and is a long-acting somatostatin analogue that inhibits the secretion of growth hormone and certain hormones secreted by the digestive system. The licensed indications of Somatuline Autogel are:11

The treatment of individuals with acromegaly when the circulating levels of Growth Hormone (GH) and/or Insulin-like Growth Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatment.
The treatment of grade 1 and a subset of grade 2 (Ki-67 index up to 10%) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease.
The treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumors. The recommended starting dose is one injection of Somatuline Autogel 120 mg administered every 28 days.

The detailed recommendations for the use of Somatuline Autogel are described in the Summary of Product Characteristics (SmPC) in the UK.11

* The decision regarding administration by the patient or a trained person should be taken by a healthcare professional.

On February 22, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that members of its management team will present at The Cowen 41st Annual Healthcare Conference on Tuesday, March 2, 2021 at 2:50 p.m. Eastern /11:50 a.m. Pacific (Press release, Invitae, FEB 22, 2021, View Source [SID1234575377]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

The live webcast of the fireside chat may be accessed by visiting the investors section of the company website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the fireside chat.