On March 16, 2022 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’) (Paris:NANO) (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that it will report its financial results for full-year ending December 31, 2021, on Wednesday, March 30, 2022, after the close of the US market (Press release, Nanobiotix, MAR 16, 2022, View Source [SID1234610192]).

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The announcement will be followed by a conference call and live audio webcast on Thursday, March 31, 2022, at 8:00 AM EDT / 2:00 PM CET, prior to the open of the US market. During the call, Laurent Levy, chief executive officer, and Bart Van Rhijn, chief financial officer, will briefly review the Company’s year-end results and an update on business activities before taking questions from analysts and investors. Investors are invited to email their questions in advance to [email protected].

A live webcast of the call may be accessed by visiting the investors section of the company’s website at www.nanobiotix.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.

On March 16, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported full year 2021 financial results and recent portfolio updates (Press release, SQZ Biotech, MAR 16, 2022, View Source [SID1234610191]).

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"We have much to be proud of as 2021 was a year of significant milestones for SQZ—a major highlight was that our lead APC candidate demonstrated monotherapy clinical benefit in an advanced patient as well as favorable safety data and tolerability across all patients in the highest dose cohort," said Armon Sharei, Ph.D., Chief Executive Officer at SQZ Biotechnologies. "In addition, we received clearance of our enhanced APC IND, a multi-functional mRNA-engineered treatment, which is now our third cell therapy candidate to advance into the clinic. We continue to expand our technical and therapeutic capabilities across disease areas. In all, the continued evolution of our portfolio of Cell Squeeze powered cell therapy candidates give us confidence that we are on the right track to potentially drive broad patient impact through a new generation of cell therapies."

2021 Full Year and Recent Portfolio Updates

SQZ Antigen Presenting Cell ("APC") Platform in Oncology

Highest dose cohort of SQZ-PBMC-HPV-101 shown to induce radiographic, symptomatic, and immune response as a monotherapy in a post-checkpoint HPV+ solid tumor patient. The December 2021 EMSO-IO oral presentation of interim-data also showed:
Tumor conversion from desert to inflamed phenotype with 8-fold increase in CD8 T Cell tumor infiltration and 50-fold increase in tumor PD-L1 expression
Favorable safety data and that the investigational therapy was generally well tolerated with no dose-limiting toxicities observed
Independent Data and Safety Monitoring Board ("DSMB") recommended that the Phase 1/2 clinical trial of SQZ-PBMC-HPV-101 advance into the combination stage with immune checkpoint inhibitors
The combination stage of SQZ-PBMC-HPV-101 trial is enrolling, and the highest-dose monotherapy stage of the trial continues enrollment to further evaluate the investigational candidate in single agent settings
Comprehensive preclinical research on SQZ APC’s ability to overcome fundamental biological barrier to effective and efficient killer T Cell activation published by the Journal of Immunology
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

FDA IND clearance of the first eAPC clinical candidate, engineered with E6, E7, CD86, membrane bound IL-2 & IL-12, was received January 2022
New eAPC preclinical data demonstrating efficient delivery of multiple mRNA to engineer APC function was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Congress in November 2021
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

New AAC preclinical data presented at SITC (Free SITC Whitepaper) demonstrated a synergistic benefit with SQZ AACs used in combination with cisplatin, an early-line chemotherapy agent for the treatment of multiple cancers
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

New TAC preclinical data presented at the 2021 Federation of Clinical Immunology Societies meeting showed the ability to induce antigen-specific immune tolerance, including Treg induction, demonstrating potential for broad applicability across autoimmune diseases
TAC celiac disease program IND-enabling studies underway to support IND FDA submission planned for the first half of 2023 with our point-of-care system targeted to manufacture clinical batches
2021 Full Year and Recent Corporate Highlights

Raised $60 million in gross proceeds from a follow-on public equity offering in February 2021
Added key board members and advisors, including Bernard Coulie, M.D., Ph.D. and Patrick Vink, M.D. to the Board of Directors, and John Maraganore, Ph.D. as a strategic advisor
Accepted for membership in the Roche China Accelerator to support certain early activities in China
2021 Full Year Financial Highlights

Revenue for the year ended December 31, 2021, was $27.1 million compared to $21.0 million for the year ended December 31, 2020
Research and development expenses for the year ended December 31, 2021, were $70.1 million compared to $51.5 million for the year ended December 31, 2020; the increase was primarily due to higher development and manufacturing costs associated with translating our product candidates into the clinic, as well as increased personnel-related costs to support continued progress with the Company’s pipeline
General and administrative expenses for the year ended December 31, 2021, were $25.7 million compared to $20.5 million for the year ended December 31, 2020; the increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs related to operating as a public company
Net loss for the year ended December 31, 2021, was $68.7 million, compared to $50.5 million for the year ended December 31, 2020
As of December 31, 2021, the Company had cash and cash equivalents of $143.5 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2023

On March 16, 2022 Proscia, the leader in digital and computational pathology solutions, reported a multi-year OEM agreement with Siemens Healthineers (Press release, Proscia, MAR 16, 2022, View Source [SID1234610190]). Under the agreement, Siemens Healthineers will expand its Enterprise Imaging offering towards the global digital pathology market using Proscia’s Concentriq Dx platform.

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The partnership comes amid a tipping point for the digital pathology market. Demand for digital pathology has surged as systemic challenges long threatening the traditional laboratory model centered around pathologists and microscopes in physical spaces have intensified in the pandemic and post-pandemic era. Mounting pressures created by a shrinking pathologist population, rising biopsy volume, and industry consolidation have been exacerbated by the pandemic-driven shift to remote work. Laboratories are now rapidly seeking to modernize their pathology operations, but legacy software systems lack the necessary enterprise-wide capabilities, preventing labs from achieving true digitization.

With Proscia’s Concentriq Dx platform, Siemens Healthineers is entering the digital pathology market to satiate the rampant demand and expand its Enterprise Imaging offering with industry-leading technology to realize the full value of digital pathology operations. Siemens Healthineers is a global leader in healthcare IT, with solutions that span nearly all major departments and disease states at the world’s leading health systems. The agreement with Proscia enables Siemens Healthineers to expand into one of the few remaining areas of healthcare that has just started to experience the full benefits of digitization.

Siemens Healthineers selected Proscia after conducting an extensive evaluation process. Several key aspects of Proscia’s technology that Siemens Healthineers cited in its decision include product maturity, superior end-user experience, open platform, future-proof capabilities, and recognized brand with in-depth domain knowledge. Siemens Healthineers’ Syngo Carbon Enterprise Imaging Solution offers a wide range of possibilities with image interpretation, reporting, AI implementation, data management, archiving and migration, including unique access to innovation platforms through seamless integration.

"Healthcare’s rapid digital transformation has emphasized the value of data in reshaping the way clinicians and researchers understand, diagnose, and fight disease," said Christian Zapf, Head of Imaging Software & IT at Siemens Healthineers. "The traditional practice of pathology is on the verge of the biggest transformation the field has seen since the introduction of light microscopy, and we’re excited to accelerate pathology’s digital transformation and pioneer breakthroughs with a strong partner complementing our core strength in enterprise reading and reporting resulting in higher efficiency and improved patient outcomes."

Proscia’s Concentriq Dx in combination with Syngo Carbon offers a best-of-breed solution for digitizing pathology operations at scale alongside diagnostic radiology imaging for healthcare enterprises. By entering the rapidly growing digital pathology market with Concentriq, Siemens Healthineers is expanding its position as one of the industry leaders in healthcare with solutions covering the entire clinical pathway, providing a full spectrum of enterprise services across digital, data, and AI.

"Our partnership with Siemens Healthineers represents a seminal moment for Proscia and a monumental leap for digital pathology on a global scale," said David West, CEO of Proscia. "We’re honored to work together with the worldwide leader in medical imaging to accelerate pathology’s digital transformation, improve the quality of care with more precise and personalized diagnoses, and ensure improved patient outcomes."

Proscia’s Concentriq is a singular, scalable platform that enables laboratory networks to unify pathology operations and eliminate the geographic silos to realize a truly connected and collaborative global practice. The platform sits at the lab’s center of gravity, connecting a diverse ecosystem of hardware and software into a single solution. Concentriq’s pathologist-centric design was developed by and for pathologists to deliver an interface that feels natural, is highly responsive, supports real-time collaboration for consults and second opinions, and makes digital image viewing as smooth as possible. The platform’s future-proof design is ready now for pathology’s computationally driven future, with an integration layer capable of supporting plug-and-play adoption of AI applications.

On March 16, 2022 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported its Bladder EpiCheck test has been included in the 2022 European Association of Urology (EAU) Clinical Guidelines for non-muscle invasive bladder cancer (NMIBC) (Press release, Nucleix, MAR 16, 2022, View Source [SID1234610187]). The EAU guidelines aim to provide practical recommendations on the clinical management of NMIBC, to assist physicians in making informed treatment decisions with available scientific data.

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The EAU guidelines state that urinary biomarker tests with high sensitivity and negative predictive values for high-grade disease, including a specific reference to Bladder EpiCheck, might be used to replace and/or postpone cystoscopies in low- and intermediate-risk NMIBC, and reduce the number of cystoscopies in this patient population.

Bladder cancer is the fifth most common cancer in the western world, but the costliest to care for, due to the need for prolonged surveillance. Because of high recurrence rate of the disease, patients undergo up to four follow-ups each year, which usually include cystoscopies that are invasive and painful.

"In follow up, many cystoscopies are negative, meaning the procedure was unnecessary. Apart from that, even when there is a high-grade recurrence, sensitivity of cystoscopies is certainly not 100%. The updated EAU guidelines illustrate that clinicians can improve NMIBC monitoring by replacing some of the cystoscopies with high-performing, non-invasive urinary markers," said Professor Fred Witjes, Professor of Medical Sciences at Radboud University Medical Center and chair of the MIBC EAU guidelines. "In our hospital we have implemented such an alternating schedule with Bladder EpiCheck which benefits the patients and is cost effective."

A comprehensive meta-analysis, entitled "Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non-Muscle Invasive Bladder Cancer: A Systematic Review and Network Meta-Analysis," was recently published in European Urology Oncology. Pooled data from five studies on Bladder EpiCheck reported an overall specificity of 85%, and a sensitivity of 91% and negative predictive value (NPV) of 99% for high grade disease. Importantly, Bladder EpiCheck demonstrated the best performance out of the guideline-recommended markers as measured by diagnostic odds ratios.

"Inclusion in the European Association of Urology’s guidelines for NMIBC will revolutionize patient care and drive adoption of Bladder EpiCheck, a non-invasive measure for surveilling the disease, which is a significant milestone for the Nucleix technology," said Aharona Shuali, M.D., vice president of medical affairs at Nucleix.

About Bladder EpiCheck

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of 91% of high-grade cancers. Bladder EpiCheck demonstrated negative predictive value (NPV) of 99% for high-grade cancer, meaning that when receiving a negative Bladder EpiCheck result, there is 99% chance that no high-grade cancer is present1. Overall specificity of Bladder EpiCheck is 85%, ensuring a low rate of false positive results. Bladder EpiCheck is intended for use as a non-invasive method for monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. Bladder EpiCheck is CE-marked and available in Europe. The test is not available for sale in the United States.

On March 16, 2022 Exscientia (Nasdaq: EXAI) reported that it will report financial results for the fourth quarter and full year ended December 31, 2021, on Wednesday, March 23, 2022 after U.S. market close (Press release, Exscientia, MAR 16, 2022, View Source [SID1234610186]). Following the announcement, the Company will host a conference call and webcast at 12:30 p.m. GMT / 8:30 a.m. ET on Thursday, March 24, 2022, to provide an overview of the company’s unique end-to-end technology platform and Exscientia’s work to fully automate drug discovery and development.

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A webcast of the live call can be accessed by visiting the "Investors and Media" section of the Company’s website at investors.exscientia.ai. Alternatively, the live conference call can be accessed by dialing +1 (888) 330 3292 (U.S.), +44 (203) 433 3846 (U.K.), +1 (646) 960 0857 (International) and entering the conference ID: 8333895. A replay will be available for 90 days under "Events and Presentations" in the "Investors and Media" section of the Exscientia website.