Dr. Thomas Cannell, President and CEO of Sesen Bio, to Participate in Fireside Chat at the 2021 Jefferies Virtual Healthcare Conference

On May 27, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that Sesen Bio President and CEO Dr. Thomas Cannell will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on June 4, 2021 (Press release, Sesen Bio, MAY 27, 2021, View Source [SID1234580713]).

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!

Event: Jefferies Virtual Healthcare Conference
Date: June 4, 2021
Time: 8:30 – 8:55 AM ET

A live webcast of the Company’s presentation will be accessible from the Investors & Media section of Sesen Bio’s website, www.sesenbio.com. An archived replay of the webcast will be available on the Company’s website for 60 days after the conference.

Medtronic Reports Fourth Quarter and Fiscal Year 2021 Financial Results; Announces 9% Dividend Increase

On May 27, 2021 Medtronic plc (NYSE:MDT) reported financial results for its fourth quarter and fiscal year 2021, which ended April 30, 2021 (Press release, Medtronic, MAY 27, 2021, View Source [SID1234583247]). The company reported fourth quarter worldwide revenue of $8.188 billion, an increase of 37 percent as reported and 32 percent on an organic basis, which adjusts for the $241 million benefit of foreign currency translation . The company’s fourth quarter results reflect a strong recovery from the impact of the COVID-19 pandemic on elective procedures that the company experienced in April 2020. Unless otherwise stated, all quarterly revenue growth rates in this press release are stated on an organic basis, which adjusts for the impact of foreign currency translation.

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!

As reported, fourth quarter GAAP net income and diluted earnings per share (EPS) were $1.361 billion and $1.00, respectively. As detailed in the financial schedules included through the link at the end of this release, fourth quarter non-GAAP net income and non-GAAP diluted EPS were $2.038 billion and $1.50, respectively, increases of 162 percent and 159 percent, respectively. Adjusting for the negative 4 cent impact from foreign currency, fourth quarter non-GAAP diluted EPS increased 166 percent.

Fourth quarter U.S. revenue of $4.182 billion represented 51 percent of company revenue and increased 47 percent. Non-U.S. developed market revenue of $2.672 billion represented 33 percent of company revenue and increased 20 percent as reported and 11 percent organic. Emerging Markets revenue of $1.334 billion represented 16 percent of company revenue and increased 44 percent as reported and 41 percent organic.

Medtronic’s fiscal year 2021 revenue of $30.117 billion increased 4 percent as reported or approximately 2 percent on an organic basis, which adjusts for the $331 million benefit of foreign currency translation, the $15 million inorganic benefit of the company’s acquisition of Titan Spine in the Cranial & Spinal Technologies division in the Neuroscience Portfolio, and the approximate $360 to $390 million benefit the company received from an extra week in its first quarter compared to the first quarter of fiscal year 2020. Unless otherwise stated, all annual revenue growth rates in this press release are stated on an organic basis, which adjusts for the impact of foreign currency translation, the inorganic benefit of Titan Spine, and the estimated benefit of the extra week.

As reported, fiscal year 2021 net earnings were $3.606 billion or $2.66 per diluted share. As detailed in the link at the end of this release, fiscal year 2021 non-GAAP earnings and diluted EPS were $6.005 billion and $4.44, respectively, both decreases of 3 percent. Adjusting for the negative 22 cent impact from foreign currency, fiscal year 2021 non-GAAP diluted EPS increased 2 percent.

Fiscal year 2021 cash flow from operations was $6.240 billion. Fiscal year 2021 free cash flow was $4.885 billion, representing free cash flow conversion from non-GAAP net earnings of 81 percent.

"We reported a strong end to our fiscal year, with our fourth quarter results demonstrating continued momentum. Our recovery improved throughout the quarter, with most of our markets returning to near normal, pre-COVID growth rates," said Geoff Martha, Medtronic chairman and chief executive officer. "In addition to supporting our employees, customers, and communities during the pandemic, we accomplished important milestones, including launching new products, investing in our pipeline, and changing our operating model, just to name a few. As we look ahead, these actions set us up to drive accelerated revenue growth in the year ahead and over the long term."

Cardiovascular Portfolio
The Cardiovascular Portfolio, formerly reported as the Cardiac and Vascular Group (CVG), includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. Cardiovascular fiscal year 2021 revenue of $10.772 billion increased 2.9 percent as reported and was approximately flat organic. Cardiovascular fourth quarter revenue of $2.908 billion increased 45 percent as reported and 41 percent organic, driven by high-fifties organic growth in CRHF and mid-twenties organic growth in both SHA and CPV.

Cardiac Rhythm & Heart Failure fourth quarter revenue of $1.539 billion increased 64 percent as reported and 59 percent organic. Cardiac Rhythm Management revenue increased in the mid-fifties, driven by mid-seventies growth in Leadless Pacemakers on the continued global adoption of the Micra transcatheter pacing system. Cardiac Ablation Solutions revenue more than doubled, with strong growth in Arctic Front Advance cryoballoon catheters and consoles. Cardiovascular Diagnostics revenue grew in the mid-eighties on procedure volume recovery. Mechanical Circulatory Support grew in the mid-teens.
Structural Heart & Aortic fourth quarter revenue of $744 million increased 30 percent as reported and 25 percent organic. Structural Heart grew in the low-fifties, driven by low-fifties growth in transcatheter aortic valves (TAVR), including low-nineties TAVR growth in the United States. Cardiac Surgery grew in the low-double digits, with broad based growth across the business. Aortic grew in the low-single digits, as the company experienced the financial impact of the previously announced global recall of the Valiant Navion thoracic stent graft system.
Coronary & Peripheral Vascular fourth quarter revenue of $624 million increased 27 percent as reported and 24 percent organic. Coronary & Renal Denervation grew in the mid-teens, including mid-teens growth in drug-eluting stents (DES). Peripheral Vascular Health grew in the mid-thirties, with mid-eighties growth in VenaSeal closure systems and low-thirties growth in IN.PACT drug-coated balloons.
Medical Surgical Portfolio
The Medical Surgical Portfolio, formerly reported as the Minimally Invasive Therapies Group (MITG), includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. Medical Surgical fiscal year 2021 revenue of $8.737 billion increased 4.6 percent as reported and in the low-single digits organic. Medical Surgical fourth quarter revenue of $2.338 billion increased 21 percent as reported and 17 percent organic, with high-twenties organic growth in SI and low-single digit organic growth in RGR.

Surgical Innovations fourth quarter revenue of $1.542 billion increased 32 percent as reported and 27 percent organic. The division had low-thirties growth in both Advanced Stapling and Vessel Sealing, driven by the continued adoption of the company’s Tri-Staple, LigaSure, and Sonicision technologies. Surgical Robotics had first revenue from Hugo robotic-assisted surgery system placements at hospitals outside the U.S. during the quarter. These systems will collect clinical data to support regulatory approvals around the world.
Respiratory, Gastrointestinal & Renal fourth quarter revenue of $796 million increased 4 percent as reported and 1 percent organic. Patient Monitoring increased in the mid-single digits, with high-single digit growth in the company’s Nellcor pulse oximetry sensors. Respiratory Interventions decreased in the high-teens, with sales of ventilators declining in the high-twenties as demand, particularly in developed markets, is returning to pre-pandemic levels. Gastrointestinal revenue increased in the high-forties, with broad-based growth across the portfolio on procedure recovery. Renal Care Solutions increased in the mid-single digits on strong growth in renal access products.
Neuroscience Portfolio
The Neuroscience Portfolio, formerly reported as the Restorative Therapies Group (RTG), includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. Neuroscience fiscal year 2021 revenue of $8.195 billion increased 6.1 percent as reported and in the mid-single digits organic. Neuroscience fourth quarter revenue of $2.295 billion increased 54 percent as reported and 51 percent organic, with high-forties growth in CST, low-fifties growth in Specialty Therapies, and low-sixties growth in Neuromodulation, all on an organic basis.

Cranial & Spinal Technologies fourth quarter revenue of $1.192 billion increased 50 percent as reported and 47 percent organic. Spine & Biologics, as well as Neurosurgery grew in the high-forties, with strong sales of spine implants utilizing Titan nanoLOCK surface technology, as well as record sales of StealthStation navigation, O-arm imaging systems, Midas Rex capital, and advanced energy products. CST also delivered strong growth in Mazor robotics with the launch of Mazor 5.0, utilizing the company’s Midas Rex drills, navigated disc prep, and interbodies with the Mazor robotic guidance system.
Specialty Therapies fourth quarter revenue of $654 million increased 56 percent as reported and 52 percent organic. Neurovascular increased in the low-twenties and ENT increased in the mid-forties. Pelvic Health increased 165%, driven by continued strong adoption of the InterStim Micro sacral neuromodulation system.
Neuromodulation fourth quarter revenue of $449 million increased 65 percent as reported and 61 percent organic. Pain Stim & Early Interventions increased in the mid-seventies, with low-seventies growth in spinal cord stimulation on strong uptake of Intellis with DTM SCS therapy. Brain Modulation increased in the high-fifties, driven by the launch of the Percept PC deep brain stimulation system. Interventional grew in the low-forties, and Targeted Drug Delivery increased in the mid-sixties.
Diabetes
Diabetes fiscal year 2021 revenue of $2.413 billion increased 1.9 percent as reported and was approximately flat organic. Diabetes fourth quarter revenue of $647 million increased 14 percent as reported and 9 percent organic. Diabetes quarterly revenue performance was driven by low-sixties growth in durable pumps on the continued launches of the MiniMed 780G system in international markets and the MiniMed 770G system in the U.S. This was offset by high-single digit declines in consumables, while continuous glucose monitoring (CGM) sales increased in the mid-single digits.

Guidance
The company today issued its fiscal year 2022 revenue and EPS growth guidance.

The company expects revenue growth in its fiscal year 2022 to approximate 9 percent on an organic basis. If current exchange rates hold, revenue growth in fiscal year 2022 would be positively affected by approximately $400 to $500 million.

In fiscal year 2022, the company expects diluted non-GAAP EPS in the range of $5.60 to $5.75, including an estimated 10 to 15 cent positive impact from foreign currency based on current exchange rates.

"Our fiscal 2022 revenue guidance that we are issuing for the first time today is about a point higher than Street estimates, as we anticipate strong organic revenue growth driven by new product launches and end market recovery from the impact of the pandemic," said Karen Parkhill, Medtronic chief financial officer. "At the same time, we’re investing at the front end of major product launches, including surgical robotics and renal denervation, to fully realize their potential. We’re also planning for the largest increase in R&D spend in our company’s history, as we invest to accelerate long-term growth and capitalize on a long list of opportunities."

Dividend Increase
The company reported that on May 26, 2021, the Medtronic board of directors approved an increase in Medtronic’s cash dividend for the first quarter of fiscal year 2022, raising the quarterly amount to $0.63 per ordinary share. This would translate into an annual amount of $2.52 per ordinary share, a 9 percent increase from the prior $2.32. Medtronic has a long history of dividend growth, and the company is a constituent of the S&P 500 Dividend Aristocrats index. Today’s announcement marks the 44th consecutive year of an increase in the dividend payment. Including today’s increase, Medtronic’s dividend per share has grown 47 percent over the past 5 years and has grown at a 16 percent compounded annual growth rate over the past 44 years.

Medtronic has a strong track record of returning capital to its shareholders, including returning $3.3 billion in fiscal year 2021. The company remains committed to returning a minimum of 50 percent of its free cash flow to shareholders, primarily through dividends, and to a lesser extent, share repurchases. The dividend is payable on July 16, 2021, to shareholders of record at the close of business on June 25, 2021.

"We’re pleased to be able to increase our dividend by 9% during the pandemic," said Martha. "Today’s dividend increase is a strong sign of our commitment to providing robust returns for our shareholders and of the confidence that our Board of Directors has in Medtronic’s financial strength and future growth opportunities."

Webcast Information
Medtronic will host a webcast today, May 27, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at news.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 2022 first, second, third, and fourth quarter results on August 24, 2021, November 23, 2021, February 22, 2022, and May 26, 2022, respectively. Confirmation and additional details will be provided closer to the specific event.

Financial Schedules
To view the fourth quarter and fiscal year 2021 financial schedules and non-GAAP reconciliations, click here. To view the fourth quarter and fiscal year 2021 earnings presentation, click here. Both documents can also be accessed by visiting news.medtronic.com.

BioTheryX Announces $92M Series E Financing to Accelerate Development of Targeted Protein Degradation Pipeline and Technology Platform in Oncology

On May 27, 2021 BioTheryX, Inc., a clinical-stage company focused on degrading proteins to create life-saving cancer medicines, reported a $92 million Series E financing led by Farallon Capital Management, with participation from additional new investors Avidity Partners, Deep Track Capital, Irving Investors, Janus Henderson Investors, Lumira Ventures, Point72, Rock Springs Capital, Surveyor Capital, Tekla Capital Management, Alexandria Venture Investors and Wedbush Healthcare Partners, and existing investors (Press release, BioTheryX, MAY 27, 2021, View Source [SID1234580406])The proceeds from the financing will be used to advance multiple molecular glues, PHM-based PROTACs and monovalent degraders, including BTX-1188, toward clinical development. BioTheryX also plans to advance the clinical development of its lead multi-kinase inhibitor, BTX-A51, for the treatment of acute myeloid leukemia, myelodysplastic syndromes and solid tumors.

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!

"We are pleased to have the support of an elite group of investors who share BioTheryX’s vision of realizing the promise of targeted protein degradation and delivering benefit to patients," said Robert Williamson, President and CEO of BioTheryX. "With this financing, we are well positioned to execute our plans to bring our first molecular glue program BTX-1188 into the clinic by the end of 2021, expand our platform of molecular glues, PROTACs and monovalent degraders and progress our lead program BTX-A51 through Phase 1."

ONK Therapeutics Secures Exclusive Global License to Patent for CISH Knockout in NK Cells for the Treatment of Cancer, from Australia’s WEHI

On May 27, 2021 ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, reported that it has entered into an exclusive global patent license agreement with Australia’s Walter and Eliza Hall Institute of Medical Research (WEHI) providing rights to CISH KO in the field of NK cells for the treatment of cancer (Press release, ONK Therapeutics, MAY 27, 2021, View Source [SID1234580662]).

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!

"Deletion of CISH in NK cells leads to an improved metabolic profile, greatly enhancing their proliferation, cytotoxicity, and persistence. In-vivo models of cancer have shown that CISH KO NK cells are much more efficient in eliminating cancer cells, making such cells a very attractive prospect for future clinical development," said Prof Michael O’Dwyer, CSO of ONK Therapeutics.

"This patent agreement builds on and strengthens the broad IP we have created at ONK Therapeutics against multiple NK cell checkpoints," added Prof O’Dwyer.

CIS (encoded by the gene CISH) is a member of the suppressor of cytokine signaling (SOCS) family of proteins. The research team at WEHI, led at the time by Prof Nick Huntington and Assoc Prof Sandra Nicholson, was the first to show the critical role that CIS plays in negatively regulating the function of NK cells. When NK cells are stimulated with growth factors, such as interleukin 15 (IL-15), which encourage their growth, survival, and killing capability, there is an increase in the activity of CIS protein, which acts as a brake or checkpoint, on further NK cell growth and function.

The WEHI team found that when CIS was removed from NK cells by deleting the CISH gene, the NK cells were more responsive to growth factors and had improved survival and killing capacity(1). Improving the metabolic fitness of NK cells to enhance glycolysis and oxidative phosphorylation is important for optimizing the anti-tumor activity of NK cells, especially against solid tumors(2-3).

"Uncovering the role of CIS as an intracellular NK cell checkpoint has been an essential discovery to further the understanding of NK cell homeostasis and turnover," said Dr. Anne-Laure Puaux, Head of Biotechnology and Commercialisation, WEHI. "We believe that our invention has the potential to improve the potency of the NK cell-based therapy platform developed by ONK Therapeutics and provide greater benefit to patients."

Under the terms of the agreement, ONK Therapeutics has secured exclusive global rights to WEHI’s patent covering the use of human NK cells lacking CISH for the purposes of researching, developing, manufacturing and commercializing NK cell therapies. The financial terms of the agreement include milestone payments and royalties on sales, the specifics of which are not disclosed.

ONK Therapeutics’ CEO Chris Nowers said, "We are very pleased that via this agreement with WEHI we have the unique ability to produce therapeutic NK cells lacking CISH for the treatment of cancer. This is another example of our innovative strategy to engineer a highly differentiated NK cell therapy platform that has broad potential across both hematological malignancies and solid tumors."

ONK Therapeutics is optimizing a unique off-the-shelf, dual-targeted NK cell therapy platform, combining the expression of a chimeric antigen receptor (CAR) and a TRAIL variant (TRAILv) and anticipates using CISH KO as a core feature of this platform. The pipeline currently has four programs in pre-clinical development across hematological malignancies and solid tumors. The Company is also exploring engineering strategies to enhance tumor homing, to optimize persistence and metabolism, and to overcome exhaustion in the tumor microenvironment, including the exploration of proprietary gene edits, such as the deletion of checkpoint receptors in NK cells, including extracellular proteins CD96, TIGIT, Siglec-7 and PD-1.

1. Delconte, R., Kolesnik, T., Dagley, L. et al. CIS is a potent checkpoint in NK cell–mediated tumor immunity. Nat Immunol 17, 816–824 (2016) View Source

2. Daher et al., Targeting a cytokine checkpoint enhances the fitness of armored cord blood CAR-NK cells Blood Sept 9, 2020

3. Zhu et al., Metabolic Reprograming via Deletion of CISH in Human iPSC-Derived NK Cells Promotes In Vivo Persistence and Enhances Anti-tumor Activity Cell Stem Cell Sept 3, 2020″

Understanding organoid morphology: a study to assess organoid size and cell count from 3D image analysis

On May 27, 2021 Cellesce reported that has carried out a study in collaboration with Cardiff University to assess organoid size and cell count from 3D image analysis (Press release, Cellesce, MAY 27, 2021, View Source [SID1234580680]). Whilst the improved predictive power of patient-derived organoids (PDOs) have the potential to replace 2D assays in drug discovery the challenge for organoid users is to fully extract, exploit and understand the increased complexity of 3D in vitro models. 3D image analysis may well provide a means to address that challenge.

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!

Many of the practical limitations have already been overcome by recent advances in microscopy, leading to improvements in 3D image resolution, speed of imaging, data acquisition and dedicated software for high-content, high throughput assays. This technology can be used to quantify changes in gross organoid morphology, such as size and shape and also detect subtle, cellular, drug-induced alterations. Multi-parametric, image-based analysis can lead to an understanding of the relationship between the morphology of 3D PDOs and the underlying cell biology Badder et al. 2020, PLOS ONE.