On March 23, 2022 Exscientia plc (Nasdaq: EXAI) reported that (Press release, Exscientia, MAR 23, 2022, View Source [SID1234610838])

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Recent advancements in the Company’s pipeline, collaborations and operations as well as financial results for the fourth quarter and full year 2021 are summarised below. In addition, Exscientia will host a conference call on Thursday, March 24 at 12:30 p.m. GMT / 8:30 a.m. ET to provide an overview of the company’s end-to-end technology platform and progress towards automating drug discovery and development.

Recent Highlights

Progressed pipeline led by significant collaborations, expansion, and programme advancement

-Year-over-year pipeline progress with 11 new programmes added, including advancement of three programmes into IND-enabling studies and two programmes to late discovery
-Partnered programmes
oEstablished collaboration with Sanofi in January 2022 focused on development of up to 15 novel small molecule candidates across oncology and immunology, received $100 million upfront cash payment with the potential of $5.2 billion in total milestones plus tiered royalties; several targets have been identified since signing
oCommenced eighth drug discovery project with Bristol Myers Squibb (BMS) in early 2022 for programme against an undisclosed oncology target
oAchieved preclinical proof of concept milestone for a target within Bayer collaboration supporting advancement into late discovery
-Co-owned programmes
oEntered into IND-enabling studies for GTAEXS-617, a CDK7 inhibitor co-owned with GT Apeiron; IND/CTA submission expected by year-end 2022; additional translational data in several tumour types to be presented at the April 2022 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and throughout 2022
oOncology target selected with EQRx, the third in the multi-target collaboration
-Wholly and majority owned programmes
oPhase 1 healthy volunteer top-line data for EXS-21546, A2a antagonist in high adenosine signature cancers, on track for the first half of 2022; translational research on identifying adenosine specific gene signatures for patient selection to be presented at AACR (Free AACR Whitepaper) 2022
oWith support from the Bill & Melinda Gates Foundation, Exscientia has designed an Mpro molecule with pan-coronavirus activity demonstrating 200x greater potency in vitro than a commercially available oral COVID-19 antiviral; ongoing compound development with candidate nomination anticipated in the second half of 2022

Balanced business model has generated meaningful cash flows and strong balance sheet

-$85.3 million cash flow from collaborations in full-year 2021, ending 2021 with $758.9 million in cash and cash equivalents
-2021 net cash outflows from operations of approximately $9.0 million
-$100 million upfront payment from Sanofi collaboration signed in January 2022

Peer-reviewed publications and upcoming scientific meeting presence showcase impact of translational research, clinical impact of precision medicine platform and differentiated technology platform

-Three abstracts accepted for poster presentation at AACR (Free AACR Whitepaper) 2022 highlight the potential of Exscientia’s precision medicine platform and AI capabilities in designing optimised molecules, improving translational research and identifying novel pathways
-EXALT-1 clinical trial results published in Cancer Discovery demonstrate the benefit of the first AI-supported functional precision medicine platform to guide treatment selection and improve outcomes in patients with advanced haematological cancers
-Select peer-reviewed publications describe recent advancements in Exscientia’s technology platform
-Fragment Hotspot Mapping to Identify Selectivity-Determining Regions Between Related Proteins describes a computational method to map protein binding pockets and identify critical regions that can be exploited to generate selective molecules
oDeep generative design with 3D pharmacophoric constraints demonstrates the potential of a new method (DEVELOP) to utilise 3D representations of molecules and generate compounds with improved properties over previous methods
oGenerating property-matched decoy molecules using deep learning showcases a deep learning method for generating molecules to validate and improve virtual screening methods

Strengthened team to position Exscientia for future growth

-Richard Law, D. Phil, has been promoted to Chief Business Officer, effective March 4, with continued focus on driving impactful collaborations across our business models
-Professor Charlotte Deane, Ph.D, joined as Chief Scientist of Biologics AI, from the University of Oxford, focused on the application of AI, machine learning, and the design of protein structures in the discovery and develpment of novel drug candidates
-Significant progress in building out clinical organisation, including clinical operations, to prepare for pipeline expansion and future clinical trials
-Experienced drug discovery team established in Boston, Massachusetts, to focus on wholly owned pipeline

"2021 was a transformational year for Exscientia as we further validated and built-out our differentiated end-to-end AI platform. We executed across our business as shown by new and expanded collaborations, growing our pipeline with eleven new programmes. We significantly expanded our global operations and scaled our capacity. On top of these achievements, we also completed our upsized IPO on Nasdaq," said Andrew Hopkins, DPhil., Exscientia’s founder and CEO. "As we look to the future, we believe we are reaching a tipping point for realising the full potential of AI-driven drug creation. We’ve already seen historic investment across the industry. Exscientia has achieved many of the "firsts" in this field and is well-positioned to lead the way. The sheer scale that our AI systems lend to scientific discovery make it possible to keep pace with breaking science in a way never before seen. This year we are focused on bringing together the team we have built and the technologies we have invented to advance new medicine programmes toward the clinic, working with our pharma and biopharma collaborators toward audacious goals to tackle rare diseases and solve persistent scientific challenges, and to continue building out our one-of-a-kind precision medicine platform to bring truly personalised medicine to patients."

Investor Call and Webcast Information

Exscientia will host a conference call on March 24 at 12:30 p.m. GMT / 8:30 a.m. ET. 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 dialling +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.

Fourth Quarter and Full Year 2021 Financial Results

For the convenience of the reader, the Company has translated pound sterling amounts to U.S. dollars at the rate of £1.000 to $1.350, which was the noon buying rate of the Federal Reserve Bank of New York on December 31, 2021.

Revenue: Revenue for the full year 2021, was $36.9 million, an increase of $23.9 million compared to the full year 2020, primarily due to the achievement of the opt-in milestone on the first candidate in-licensed under Exscientia’s collaboration with BMS.

R&D and cost of drug discovery: Due to various collaboration structures, R&D expenses may be included under multiple accounting line items. The tables below show how these expenses are separated across the accounting categories.

On March 22, 2022 Nucleai, an AI-powered spatial biology company with a mission to transform drug development and clinical treatment decisions by unlocking the power of pathology data, reported that it had closed a $33 million Series B financing round, jointly led by Section 32 and Sanofi Ventures (Press release, Debiopharm, MAR 22, 2022, View Source [SID1234610576]). Andy Harrison, Managing Partner at Section 32, and Cris De Luca, Global Head, Digital Investments at Sanofi Ventures, will join Nucleai’s Board of Directors. Section 32 Managing Partner Michael Pellini, MD, will join Nucleai’s Board as an observer. Nucleai plans to use the new funding to further develop its platform and expand its commercial footprint across biopharmaceutical companies and contract research organizations (CROs), who are applying its technology throughout translational research, clinical trials, and novel applications for drug discovery.

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Existing investors, including Debiopharm, Fosun RZ Capital, Vertex Ventures, and Grove Ventures, participated in this round. This Series B financing brings Nucleai’s overall funding to close to $50 million since the company was founded four years ago.

"Nucleai’s vision is to bring spatial biology to the forefront of precision medicine and to embed the use of our platform in every clinical trial involving tissue over the next few years," said Avi Veidman, CEO of Nucleai. "We are pleased to bring world-class investors who share our passion and vision to transform drug development and clinical treatment decisions by combining artificial intelligence, big data, spatial biology, and a comprehensive software platform."

Andy Harrison commented, "Mapping biological microenvironments with spatial mapping technology is an exciting area of discovery that is paving the way for innovative new therapies and diagnostic tools. Nucleai has built a platform that makes spatial analysis scalable and operational, enabling the next generation of actionable insights from massive pathology data sets that have not been analyzed to their fullest potential and could provide significant value to pharmaceutical companies and diagnostic labs."

"The rapid growth and achievements of the Nucleai team have them well-positioned to be spatial biology platform leaders, transforming current approaches to pathology," said Cris De Luca. "By harnessing artificial intelligence with spatial data and other data modalities, Nucleai is enabling researchers and clinicians to make better treatment decisions for patients based on a comprehensive, holistic view of cellular locations, interactions, and the tumor microenvironment."

Nucleai is working with most of the leading pharmaceutical companies to harness spatial biology for new drug development, clinical trials, and clinical treatment decisions. Nucleai’s platform is leveraged for retrospective and prospective patient stratification analysis in clinical trials, driving improvement of the probability of success and improved patient outcomes. Nucleai delivers a comprehensive solution that brings the computational power and scales needed to discover novel biomarkers, predicts patient response with higher-quality predictive biomarkers, identifies new targets, and develops the next generation of pathology-based companion diagnostics.

On March 22, 2022 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for cancer patients suffering from solid tumors, reported financial results for the fourth quarter ended December 31, 2021 and provided a corporate update (Press release, TCR2 Therapeutics, MAR 22, 2022, View Source [SID1234610601]).

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"Consistent execution throughout the last year has positioned TCR2 for a series of important readouts as we accelerate our clinical progress in 2022," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "We were able to successfully conclude the dose escalation portion of our ongoing gavo-cel Phase 1/2 clinical trial with the identification of a RP2D and submit a protocol amendment with the FDA for the upcoming Phase 2 clinical trial. We also submitted an IND with the FDA for our first enhanced TRuC-T cell that incorporates a PD-1:CD28 switch. In the meantime, we have been identifying new clinical trial sites and expanding manufacturing capacity for the reproducible process used by Miltenyi and ElevateBio to support our clinical trials. In addition to the clinical readouts from gavo-cel and TC-510, we will continue to provide updates on the innovations in our rapidly growing pipeline, most immediately with a preclinical data presentation on our allogeneic TRuC targeting mesothelin at the AACR (Free AACR Whitepaper) Annual Meeting in April."

Recent Developments

Gavo-cel:

•TCR2 announced the submission of a protocol amendment to the US Food and Drug Administration (FDA) in the first quarter of 2022 for the gavo-cel Phase 2 expansion cohort, including the amendment to treat patients with gavo-cel in combination with Opdivo and/or Yervoy which forms the basis of the Company’s clinical trial collaboration with Bristol Myers Squibb.

TC-510:

•TCR2 announced the submission of an Investigational New Drug (IND) to the FDA in the first quarter of 2022 for TC-510, the Company’s first enhanced TRuC-T cell targeting mesothelin with a PD-1:CD28 chimeric switch receptor.
Pipeline:

•TCR2 announced it will present a poster at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 featuring new preclinical data on an allogeneic (off-the-shelf) TRuC-T cell, taking place on April 8-13, 2022 in New Orleans, Louisiana. In preclinical studies, this allogeneic product candidate without an enhancement demonstrated improved anti-tumor efficacy associated with enhanced persistence and increased antigen sensitivity in vivo compared to donor-matched autologous TRuC-T cells targeting mesothelin. Furthermore, allogeneic TRuC-T cells generated with an additional knockout of Beta-2-microglobulin (B2M) maintained their potency.
•TCR2 announced a strategic research collaboration agreement with Arbor Biotechnologies focused on the further development of a defined set of allogeneic TRuC-T cell therapies. The collaboration leverages Arbor’s proprietary CRISPR gene-editing technology, which is tailored to address the underlying pathology of genetic diseases and TCR2’s first-in-class TRuC platform, which has demonstrated clinical activity in multiple treatment-refractory mesothelin-expressing solid tumor indications with gavo-cel.

Corporate:

•TCR2 announced the appointment of experienced biotech executive Rosemary Harrison, Ph.D., as Chief Business and Strategy Officer where she will be responsible for supporting a range of activities including commercial strategy, operational planning, corporate partnerships and long-term growth opportunities.

Anticipated Milestones

•Gavo-cel:
oPresent the expanded and complete Phase 1 dataset for gavo-cel in the second quarter of 2022.
oInitiate the Phase 2 expansion cohort of the ongoing gavo-cel Phase 1/2 clinical trial in the first half of 2022.
oProvide an initial update from at least one of the Phase 2 expansion cohorts of the ongoing gavo-cel Phase 1/2 clinical trial in the second half of 2022.
•TC-510:
oReport initial safety, efficacy and translational data from at least one of the Phase 1 dose escalation cohorts of the TC-510 Phase 1/2 clinical trial in the second half of 2022.
•Pipeline:
Initiate IND-enabling studies for TC-520, an enhanced CD70 targeting TRuC-T cell program, in 2022.
oSelect a lead candidate for its allogeneic program in 2022.
•Manufacturing:
oProduction of clinical trial material to commence at ElevateBio BaseCamp as capacity is increased in anticipation of demand from the Phase 2 expansion trial of gavo-cel in 2022.

Financial Highlights

•Cash Position: TCR2 ended the fourth quarter of 2021 with $265.6 million in cash, cash equivalents, and investments compared to $228.0 million as of December 31, 2020. Net cash used in operations was $23.3 million for the fourth quarter of 2021 compared to $13.5 million for the fourth quarter of 2020. TCR2 projects net cash use of $115-125 million for 2022. We expect cash on hand to support operations into 2024.

•R&D Expenses: Research and development expenses were $22.4 million for the fourth quarter of 2021 compared to $14.3 million for the fourth quarter of 2020. The research and development expenses for the fourth quarter of 2021 include restructuring costs of $3.7 million and are partially offset by a $2 million settlement from a vendor due to a commercial dispute. The remaining increase in R&D expenses was primarily due to an increase in headcount and manufacturing facilities.

•G&A Expenses: General and administrative expenses were $5.2 million for the fourth quarter of 2021 compared to $4.3 million for the fourth quarter of 2020. The increase in general and administrative expenses was primarily due to an increase in personnel costs.

•Net Loss: Net loss was $27.7 million for the fourth quarter of 2021 compared to $18.5 million for the fourth quarter of 2020.

On March 22, 2022 Median Technologies (ALMDT:PA) reported outstanding performance of its iBiopsy LCS AI/ML tech-based end-to-end CADe/CADx Software as Medical Device, intended to enable early detection and characterization of lung cancer nodules and improve clinical management of patients (Press release, MEDIAN Technologies, MAR 22, 2022, View Source [SID1234610618]).

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Median’s iBiopsy LCS SaMD offers a unique end-to-end detection/diagnosis approach (CADe/CADx) based on AI/ML technologies. Median aims at drastically improving the ability to detect and characterize lung cancers at their earliest stages, enabling a better patient care while avoiding unnecessary medical tests and procedures, and reducing healthcare costs. No product is currently approved for both lung cancer detection and diagnosis in the US or Europe. With this breakthrough innovation, Median’s iBiopsy LCS SaMD brings a unique AI-powered solution for clinicians to fight lung cancer, the deadliest cancer worldwide.

Results released today show unrivalled performance for Median’s end-to-end detection/diagnosis approach for lung cancer screening.

The study was based on a cohort of 1,760 patients from the National Lung Screening Trial (NLST) consisting of a total of 16,789 lung nodules. The training set was composed of a subset of 1,289 patients with 12,108 nodules and the test set represented 471 patients with a total of 4,681 nodules.

The performance of iBiopsy LCS CADe/CADx SaMD to detect and characterize lung cancer nodules achieves an AUC of 0.976 and an outstanding sensitivity of 94.7% for a specificity of 93.3%.

"We are thrilled to announce our performance. These results pave the way for a disruptive approach in lung cancer screening management", Fredrik Brag, CEO and founder of Median Technologies said. "We have already initiated our interactions with the FDA with the recent 513(g) submission, which will allow us to determine the best FDA regulatory pathway for our iBiopsy LCS SaMD. Our next step will be to integrate the FDA’s comments in the protocols of the pivotal clinical studies that we will launch in the second half of 2022. In parallel, we are reviewing our regulatory pathway to the CE-Mark in Europe", Brag added.

Median Technologies aims to obtain a device approval and market authorization by the end of 2023.

About iBiopsy: iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median’s expertise in medical image processing. iBiopsy targets the development of innovative AI/ML-based Software as Medical Device, to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on lung cancer, liver cancer (HCC) and liver fibrosis (NASH).

On March 22, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported that Company’s Management will provide a corporate update and participate in a panel discussion entitled "Pancreatic Cancer: Turning the Tide for One of the Most Challenging Indications in Oncology," at the Maxim 2022 Virtual Growth Conference, to be held virtually March 28-March 30, 2022 (Press release, Synthetic Biologics, MAR 22, 2022, View Source [SID1234610749]).

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Details on the panel discussion include:

Title: "Pancreatic Cancer: Turning the Tide for One of the Most Challenging Indications in Oncology"

Date: March 28, 2022

Time: 12:00 p.m. – 1:00 p.m. ET

The conference will be available through the M-Vest portal for registered members.