On May 3, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company" or "We") (OTCQB:OTLC), reported the appointment of Dr. Fatih Uckun as its Chief Medical Officer (Press release, Oncotelic, MAY 3, 2022, View Source [SID1234613416]). Dr. Uckun will be responsible for execution of internal company led registrational trials.

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 addition of Dr. Uckun to our executive team, comes at a critical time for Oncotelic. We have made significant inroads toward our goal of developing OT-101 as treatment for difficult to treat cancers," said Dr. Vuong Trieu, CEO and Chairman. "Dr. Uckun is one of the highest caliber physician scientists. His deep knowledge in clinical oncology and vast experience in translational research for successful applications of immunotherapy in oncology, especially for difficult to treat cancer subtypes will be invaluable, as we further advance OT-101 and the rest of our product portfolio."

"With the completion of the joint venture with Dragon Overseas Capital Limited for OT-101, we will be initiating OT-101 registration trials against difficult to treat cancers such as DIPG and pancreatic cancers", said Dr. Fatih Uckun, CMO. "I look forward to engaging the global oncology community in bringing OT-101 to these patients."

About Dr. Uckun

Dr. Uckun is an elected Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He received numerous awards for his work on monoclonal antibodies, recombinant cytokines and fusion proteins, radiation sensitizers, kinase inhibitors and targeted therapeutics for difficult-to-treat cancers, including the Stohlman Memorial Award of the Leukemia Society of America, the highest honor given to a Leukemia Society Scholar.

Prior to joining Oncotelic, Dr. Uckun served as Chief Medical Officer and Chief Scientific Officer of Reven Pharmaceuticals (from 2020 to 2022), Chief Medical Officer of Ares Pharmaceuticals (from 2017 to 2022), Chief Clinical Advisor of Aptevo Therapeutics (2021), Vice President and Clinical Strategy Lead, Oncology-Hematology of Worldwide Clinical Trials (2020), Chief Medical Officer of Mateon and Oncotelic (2019-2020), and Executive Medical Director and Strategy Lead in Global Oncology and Hematology at Syneos Health (from 2017 to 2018). Prior to this, he was Vice President of Research and Clinical Development at Nantkwest, Chief Scientific Officer of Jupiter Research Institute and, before that, held senior-level scientific and research positions at Parker Hughes Institute and its cancer center, Paradigm Pharmaceuticals, and the Children’s Cancer Study Group.

Dr. Uckun earned his doctoral degrees at the University of Heidelberg, Germany where he also served as an active member of the autologous bone marrow transplant and peripheral stem cell transplant clinical research teams of the Tumor Center. Dr. Uckun completed his residency training in pediatrics, clinical fellowship training in Hematology/Oncology/Blood and Bone Marrow Stem Cell Transplantation as well as postdoctoral research training in immunology at the University of Minnesota. Dr. Uckun has more than 30 years of professional experience in developmental therapeutics with a special emphasis on targeted therapeutics/precision medicines and biopharmaceuticals. He has published more than 500 peer-reviewed papers, authored numerous review articles and book chapters and and is an inventor on numerous patents.

Dr. Uckun worked as a Professor of Therapeutic Radiology-Radiation Oncology, Pharmacology, and Pediatrics as well as Director of the Biotherapy Institute at the University of Minnesota (1986-1997), where he became the first recipient of the Endowed Hughes Chair in Biotherapy, and as a Professor of Pediatrics and Head of Translational Research in Leukemia and Lymphoma of the Children’s Center for Cancer and Blood Diseases at the University of Southern California (2009-2015). From 2012-2015, Dr. Uckun served as chair of the Biotargeting Working Group and a Member of the Coordination and Governance Committee of the NCI Alliance for Nanotechnology in Cancer.

On May 3, 2022 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported it will host a conference call to discuss its financial results for the year ended December 31, 2021 today at 5 pm ET (Press release, Perimeter Medical Imaging AI, MAY 3, 2022, View Source [SID1234613433]).

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!

Details on company presentations and webcasts can be found on the "Investors" section of Perimeter’s website at View Source When available, webcasts will be posted for replay following the event. The above listed dates and times are subject to change.

On May 3, 2022 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) reported financial results for the quarter ended March 31, 2022 (Press release, Zimmer Holdings, MAY 3, 2022, View Source [SID1234613450]). The Company reported first quarter net sales from continuing operations of $1.663 billion, an increase of 3.9% over the prior year period, and an increase of 6.8% on a constant currency basis. Net earnings from continuing operations for the first quarter were $73.0 million, or $337.4 million on an adjusted1 basis.

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!

Diluted earnings per share from continuing operations were $0.35 for the first quarter, and adjusted diluted earnings per share from continuing operations were $1.61.

"We are encouraged by the better than expected results seen in Q1, driven by COVID recovery and continued execution by the Zimmer Biomet team. This performance increases our confidence level for 2022 and we are raising and tightening our guidance accordingly," said Bryan Hanson, Chairman, President and CEO of Zimmer Biomet. "Our underlying business remains strong, fueled by innovation in our portfolio and an acceleration of our transformation activities. I continue to be proud of how the Zimmer Biomet team is executing against our mission so that we can serve healthcare providers and their patients while delivering value for shareholders."

1 Reconciliations of these measures to the corresponding U.S. generally accepted accounting principles measures
are included in this press release.

Recent Highlights

Aligned with the ongoing transformation of Zimmer Biomet’s business, key first quarter highlights include:

Successful completion of the spinoff of ZimVie, Zimmer Biomet’s former spine and dental businesses, on March 1, 2022.
Launch of WalkAI, a dynamic artificial intelligence (AI) model designed to predict which patients will have a lower walk speed at 90 days after hip or knee surgery. WalkAI, Zimmer Biomet’s first AI-based solution, adds powerful predictive analytic capabilities to ZBEdge, a suite of integrated smart, digital and robotic technologies purposefully engineered to deliver transformative data-powered clinical insights with the goal of improving patient outcomes.
Receipt of key recognition and awards including: earning a 100 percent rating on the 2022 Human Rights Campaign (HRC) Foundation’s Corporate Equality Index, a globally recognized, national benchmarking survey on corporate policies, practices and benefits pertinent to LGBTQ+ workplace equity; ranking among the top 500 companies on Forbes’ list of America’s Best Large Employers for 2022; and inclusion in Fast Company’s list of Most Innovative Robotics Companies in 2022 for ROSA Robotics, a multi-application platform that utilizes Zimmer Biomet’s leading implants and data technologies to redefine robotics by providing real-time insights to optimize patient outcomes.
ZimVie Spinoff Transaction

The Company completed the spinoff of ZimVie Inc. (ZimVie) on March 1, 2022. The historical results of the spine and dental businesses that were contributed to ZimVie in the spinoff are excluded from net sales and expenses and reflected as discontinued operations in the Company’s Condensed Consolidated Statements of Earnings for the periods presented in this release. The financial information presented in this release reflects the Company’s results on a continuing operations basis, and prior periods have been recast to conform to this presentation.

Geographic and Product Category Sales

In the three-month period ended March 31, 2022, the Company updated its geographic sales reporting. Geographic results now are presented by a United States geography and an International geography. Previously, net sales were reported by three geographies: Americas, EMEA, and Asia Pacific.

Prior period net sales have been reclassified to the current presentation, including reclassification of net sales related to the spine and dental businesses to discontinued operations.

Please see the attached schedules accompanying this press release for additional details on performance in the quarter, including net sales by Zimmer Biomet’s two geographies and four product categories.

The following sales table provides results by geography and product category for the three-month period ended March 31, 2022, as well as the percentage change compared to the prior year period, on both a reported basis and a constant currency basis.

Financial Guidance

The Company is updating its full-year 2022 financial guidance to raise and tighten its previous projected ranges for revenue growth, foreign currency exchange impact and adjusted diluted EPS from continuing operations:

Conference Call

The Company will conduct its first quarter investor conference call today, May 3, 2022, at 8:30 a.m. ET. The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

On May 2, 2022 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported that Astrego Diagnostics AB (HQ: Uppsala, Sweden; CEO: Ove Öhman) has become a wholly-owned subsidiary through the acquisition of outstanding shares and that the company name has changed to Sysmex Astrego AB (Press release, Sysmex, MAY 2, 2022, View Source [SID1234613265]). Going forward, in addition to accelerating the clinical application of rapid antimicrobial susceptibility testing1 for urinary tract infections,2 the companies aim to contribute to solving the problem of antimicrobial resistance (AMR)3 and other issues related with healthcare.

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!

Urinary tract infections are infectious diseases with a high rate of incidence and are said to affect 150 million people globally4. Making a proper diagnosis and using an effective antimicrobial in a timely manner is of crucial importance in the treatment of bacterial infections. For this purpose, in addition to clinical findings, bacterial identification tests5 and antimicrobial susceptibility tests are required; however, such testing can require several days in the current situation, making it difficult to prescribing antimicrobials based on test results at the first consultation. As a result, the appearance of antimicrobial-resistant bacteria due to improper antimicrobial use has become a problem. This is not limited to urinary tract infections. As a factor in the development of drug-resistant bacteria, the improper use of antimicrobials is becoming a global issue. If measures against AMR are not taken, in 2050, it is estimated that annual worldwide deaths due to drug-resistant bacteria will exceed 10 million6, more than those due to cancer. At the World Health Assembly held in May 2015, the Global Action Plan on Antimicrobial Resistance was adopted and initiatives toward countermeasures have been gathering speed, particularly among developed countries.

Astrego’s unique and proprietary microfluidic technology (View Source) involves forming microchannels at the micrometer to nanometer level, capturing individual bacteria from among the multiple bacteria present in a fluid and the bacteria are then cultured unidirectionally within these tiny channels, which achieves a rapid antimicrobial susceptibility test result. Astrego has been developing a rapid antimicrobial susceptibility test for urine samples. With the aim of commercializing Astrego’s rapid antimicrobial susceptibility test, Sysmex acquired 24.99% of Astrego’s shares in 2020. The companies have been conducting joint product development activities and on March 23, 2022, completed a self-declaration and CE-marking according to Directive 98/79/EC on in vitro diagnostic medical devices.

In May 2022, Sysmex acquired outstanding shares in Astrego to strengthen synergies between the companies and accelerate clinical application of the rapid antimicrobial susceptibility test. With the acquisition, Astrego became a wholly-owned subsidiary of Sysmex, and the company name changed to Sysmex Astrego AB.� In addition to working on the further development of diagnostic technologies, the two companies will contribute to solving medical issues through such endeavors as measures to reduce the occurrence of antimicrobial resistance and promote the proper stewardship of antimicrobial drugs to improve patient QOL and efficiency in medical care.

Overview of Astrego Company name: Sysmex Astrego AB Location: Uppsala, Sweden Representative: Mikael Olsson Capital: 76,476 Swedish Krona Capital supplied by: Sysmex Corporation Employees: 38 Line of business: Development of in vitro diagnostic products related to drug susceptibility References January 29, 2020 press release entitled "Sysmex Invests in Astrego Diagnostics with a View to Developing New Urinalysis Solutions for the Primary Care Business" View Source November 4, 2021 story entitled "What Is Antimicrobial Resistance (AMR)?-Tackling Global Threats and Aiming to Create a Sustainable Society-" View Source

Terminology

1 Antimicrobial susceptibility test: A test to determine the efficacy of various antimicrobial drugs against pathogenic bacteria detected in a sample.
2 Urinary tract infections: The urinary tract runs between the kidneys and the urethral opening. Inflammations due to the incursion of bacteria into the urinary tract are known as urinary tract infections. Such infections can lead to bladder inflammation and pyelonephritis (inflammation of the kidneys).
3 Antimicrobial resistance (AMR): This phenomenon occurs when living organisms develop a resistance to a drug, whose efficacy is reduced or nullified as a result. Bacteria that have developed microbial resistance are known as antimicrobial-resistant bacteria.
4 "Antimicrobial resistance among uropathogens that cause community-acquired urinary tract infections in women: a nationwide analysis." Clinical Infectious Diseases. 2001;33(1):89–94. doi: 10.1086/320880.
5 Identification test: A test to determine the name of bacteria that are the source of an infectious disease � detected in a sample.
6 "Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations." The Review on Antimicrobial Resistance, Chaired by Jim O’ Neill.

Sysmex’s materiality
Sysmex has identified "Resolution of medical issues through products and services" as one of the issues that we prioritize (materiality) as we work to develop and supply products with high clinical value. Leveraging our proprietary technology and the global network that we have cultivated thus far, we con

On May 2, 2022 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the presentation of three abstracts featuring potential first-in-class radioenhancer NBTXR3 at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 3-7 (Press release, Nanobiotix, MAY 2, 2022, View Source [SID1234613287]).

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 aiming to significantly improve outcomes for patients with cancer through NBTXR3, and to do so we must validate the safety and efficacy of our innovation across solid tumor indications and in combination with existing treatment modalities," said Laurent Levy, co-founder and chief executive officer of Nanobiotix. "Taken together with data we have previously reported on NBTXR3 as a single agent and in combination with checkpoint inhibitors, we expect the findings that will be presented at ASCO (Free ASCO Whitepaper) this year to add a new dimension to the story of NBTXR3 as we observe the radioenhancer’s performance in combination with chemotherapy. We will also highlight the design of our ongoing pivotal phase III study evaluating NBTXR3 as a single agent for frail, elderly patients with head and neck cancer."

The accepted abstracts include:

Abstract #18041: PEP503 (NBTXR3), a Radioenhancer, in Combination with Concurrent Chemoradiation (CCRT) in Locally Advanced or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC): Dose-Finding of a Phase 1b/2 Trial
Abstract #3603: A Phase 1b/2 Study of Radioenhancer, PEP503 (NBTXR3), in Combination with Concurrent Chemoradiation in Locally Advanced or Unresectable Rectal Cancer
Abstract #TPS6110: A Phase III Pivotal Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-ineligible Elderly Patients with Locally Advanced Head & Neck Squamous Cell Carcinoma
About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product, composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physics-based mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering an adaptive immune response and long-term anti-cancer memory. Given the MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly, with immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study, evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and for patients with lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy, either naïve or resistant to prior PD-1 (either primary or secondary as per SITC (Free SITC Whitepaper) criteria).

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in strategic collaborations to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations. In 2021, the Company entered into an additional strategic collaboration agreement with LianBio to support its global phase III study in Asia along with four future registrational studies.