On May 2, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported that it filed its annual report on Form 20-F (the "Form 20-F") for the year ended December 31, 2021 with the U.S. Securities and Exchange Commission ("SEC") on April 26, 2022 (Press release, Ambrx, MAY 2, 2022, View Source [SID1234613334]). The Form 20-F can be accessed by visiting either the SEC’s website at www.sec.gov or the Company’s website at www.ambrx.com.

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The Company will provide a hard copy of the annual report containing its audited consolidated financial statements, free of charge, to its shareholders and holders of its American Depositary Shares upon request. Requests should be directed in writing by email to [email protected].

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.

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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]).

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"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.

On May 2, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, reported that it will report its financial results for the first quarter ended March 31, 2022 and provide recent clinical and corporate updates via a press release on Thursday, May 5, 2022 at 4:05pm Eastern Time (ET) (Press release, Gritstone Oncology, MAY 2, 2022, View Source [SID1234613303]).

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To facilitate engagement with the company’s shareholder base and connections with its investors, Gritstone is partnering with Say Technologies to enable shareholders to submit and upvote questions through Say’s online portal, a selection of which will be answered by Gritstone management via a post on the IR section of the company’s website at View Source

From 9:00am ET Tuesday, May 3 through 5:00pm ET Friday, May 6, all shareholders can submit questions at the following link: View Source

Gritstone will then post a response addressing select questions after market close on Wednesday, May 11.

Shareholders can email [email protected] for any support inquiries.

On May 2, 2022 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported plans to release its financial results for the first quarter ended March 31, 2022 on Monday, May 9, 2022 following the close of financial markets (Press release, Akebia, MAY 2, 2022, View Source [SID1234613319]).

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Akebia will host a conference call Monday, May 9, 2022 at 4:30 p.m. ET to discuss its financial results and provide a general business update. To listen to the conference call on May 9th, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 1273066. The call will also be webcast LIVE and can be accessed via the Investors section of Akebia’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through May 15, 2022. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 1273066. An online archive of the conference call can be accessed via the Investors section of Akebia’s website at View Source