On November 17, 2021 Exscientia (Nasdaq: EXAI) reported that (Press release, Exscientia, NOV 17, 2021, View Source [SID1234595751])

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Recent advancements in the Company’s pipeline, collaborations and operations as well as financial results for the third quarter ended September 30, 2021 are summarised below. In addition, Exscientia will host a conference call on Thursday, November 18 at 1:30 p.m. GMT / 8:30 a.m. ET to provide detail on the business models underlying the Company’s pipeline of more than 25 programmes.

Highlights

Leveraging deep learning on patient tissue samples at scale to transform target discovery and patient selection

– Expanded investigation of patient tissue models in solid tumours, including ongoing analysis of EXS-617 in ovarian and breast cancer models

– Published EXALT-1 clinical trial results in Cancer Discovery that highlighted benefit of the first AI-supported functional precision medicine platform to guide treatment selection and improve outcomes in patients with advanced haematological cancer

– Completed acquisition of Allcyte, integrating leading tissue platform into Exscientia’s end-to-end drug discovery operations

Pipeline progress marked by candidate nomination, significant expansion of existing collaborations

– Partnered programmes

Expanded Bristol Myers Squibb collaboration to include potential targets across immunology and oncology; potential deal value beyond $1.3 billion
BMS in-licensed first candidate from original 2019 collaboration, a potential first-in-class immunology medicine, triggering $20.0 million option exercise fee
– Co-owned programmes

EXS-617: development candidate nominated for CDK7 inhibitor from expanded joint venture with GT Apeiron; additional translational data anticipated 1H 2022
First two targets selected in EQRx joint venture
– Wholly and majority owned programmes

EXS-21546: Phase 1 data for A2a antagonist in high adenosine signature cancers expected 1H 2022; translational research programmes for patient selection ongoing
Entered into third collaboration with Bill & Melinda Gates Foundation that added portfolio of up to five antiviral small molecule drug candidates and accelerated development of SARS-CoV-2 lead programme
Strengthened balance sheet providing several years of cash runway to deliver AI-designed molecules and accelerate pipeline growth

– Expect between $75.0-$85.0 million in cash inflows from collaborations for full year 2021

– In October, closed $510.4 million gross aggregate financing, consisting of $350.4 million gross proceeds from upsized initial public offering and $160.0 million gross proceeds from concurrent private placement

– Cash at the end of the third quarter 2021, adjusted to include the net proceeds from the initial public offering completed on October 5, 2021, was $783.7 million

Expanding drug discovery and automation laboratories to scale capacity and operations

– Opened 21,000-square foot expansion of facilities at Oxford Science Park

– Building 26,000-square foot laboratory in Milton Park, Oxfordshire focused on the automation of chemistry and biology to accelerate drug discovery

– Building 50,000-square foot precision medicine centre of excellence in Vienna, Austria

– Added to U.S. footprint with expansion in Miami, opening of office in Boston, and key hires in strategic operations, technology and chemistry

"Exscientia is leading the modernisation of how new medicines are created by using AI in each step of discovery and development. Demonstrating our unique translational capabilities, we recently published groundbreaking results showing our AI precision medicine platform can improve outcomes for cancer patients. We have also propelled our pipeline through substantial investment in our own new medicine programmes, significantly expanded our relationship with Bristol Myers Squibb, and added a portfolio of pandemic preparedness antivirals to our work with the Bill and Melinda Gates Foundation. Finally, we began expanding our labs, investing in scaling our precision medicine platform and automated synthesis and screening," said Andrew Hopkins, DPhil., Exscientia’s founder and CEO. "We have incredible momentum, and with our solid balance sheet post IPO, we will continue investing in innovation that can enable the rapid translation of today’s most promising science into tomorrow’s best possible medicines."

Investor Call and Webcast Information

Exscientia will host a conference call on November 18 at 1:30 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 dialing +1 760 294 1674 (U.S.), +44 203 059 5869 (U.K.), +44 203 059 8128 (International) and mentioning Exscientia. A replay will be available for 90 days under "Events and Presentations" in the "Investors and Media" section of the Exscientia website.

Third Quarter 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 $1.347, which was the noon buying rate of the Federal Reserve Bank of New York on September 30, 2021.

Revenue: Revenue for the nine months ended September 30, 2021, was $31.3 million, an increase of $23.6 million compared to the nine months ended September 30, 2020, primarily due to the achievement of the opt-in milestone on the first candidate in-licensed on 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.

General and administrative expenses: G&A expenses for the nine months ended September 30, 2021 were $26.1 million, or 34% of total operating expenses. For the nine months ended September 30, 2021, G&A expenses grew by $20.2 million compared to the nine months ended September 30, 2020, primarily associated with both an expansion of internal capabilities as well as transaction-related professional services.

Financial Outlook for 2021 & 2022

For the first three quarters of 2021, Exscientia announced three new partnerships and received $65.4 million cash inflows from its collaborations. The Company expects to receive a total of $75.0-$85.0 million by year-end 2021, and anticipates 2022 cash inflows from collaborations will exceed 2021 cash inflows from collaborations. Exscientia expects to end 2021 with cash and cash equivalents between $745.0-$755.0 million.

On November 17, 2021 Pfizer Inc. (NYSE: PFE) reported the successful completion of its acquisition of Trillium Therapeutics, a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer (Press release, Pfizer, NOV 17, 2021, View Source [SID1234595750]).

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As Trillium becomes part of Pfizer, it brings an impressive portfolio that includes biologics that are designed to enhance the ability of patients’ innate immune system to detect and destroy cancer cells. Its two lead molecules, TTI-622 and TTI-621, block the signal-regulatory protein α (SIRPα)–CD47 axis, which is emerging as a key immune checkpoint in hematological malignancies. TTI-622 and TTI-621 are novel SIRPα-Fc fusion proteins that are currently in Phase 1b/2 development across several indications, with a focus on hematological malignancies. Both molecules are also being tested to evaluate clinical potential in solid tumors.

"We are proud to bring Trillium’s leading scientific talent and pipeline into Pfizer," said Chris Boshoff, MD, PhD, Chief Development Officer, Oncology, Pfizer Global Product Development. "Today’s announcement combines Pfizer’s research and global development capabilities with Trillium’s innovative discoveries, allowing us to accelerate breakthroughs that change patients’ lives."

Hematological malignancies are cancers that affect the blood, bone marrow, and lymph nodes. This classification includes various types of leukemia, multiple myeloma, and lymphoma. More than 1 million people worldwide were diagnosed with a blood cancer in 2020, representing almost 6% of all cancer diagnoses globally. In 2020, more than 700,000 people worldwide died from a form of blood cancer.

Additional Transaction Details

Pfizer has completed its acquisition of all outstanding shares, warrants, options, and deferred share units of Trillium not already owned by Pfizer for $18.50 per share, in cash, representing an aggregate purchase price of approximately $2.22 billion. The acquisition was completed by way of a statutory plan of arrangement under the Business Corporations Act (British Columbia) and, as a result of the acquisition, Trillium became a wholly-owned subsidiary of Pfizer. In connection with the acquisition, Trillium’s common shares will be delisted from the Nasdaq Capital Market. Trillium’s common shares will be delisted from the Toronto Stock Exchange on or before November 19, 2021.

For additional background on the acquisition, please read the announcement press release here.

About Pfizer Oncology

At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.

On November 17, 2021 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, reported that enrollment and testing of patients has begun at the Department of Obstetrics & Gynecology Hospital of Fudan University located in Shanghai (Press release, Guided Therapeutics, NOV 17, 2021, View Source [SID1234595749]).

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The data will be submitted to the Chinese National Medical Products Administration (NMPA; formerly known as the Chinese FDA). Upon such submission, $620,000 is due to Guided Therapeutics from the Company’s Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI). The balance of the $2.5 million purchase order from SMI (i.e., $1,880,000) will be due and payable upon marketing approval from NMPA.

"Starting the pivotal clinical trial in China is a key milestone in our international commercialization strategy," said Gene Cartwright, CEO of Guided Therapeutics. "The study is very reasonable in terms of number of women to be tested and it is a pleasure to be working with thought leaders in the Chinese Gynecological and Obstetrics community."

According to the World Health Organization, cervical cancer is one of the most frequent cancers in women in the world and in China it is the second most common cancer among women. China has a population of approximately 560 million women above 15 years of age, who are at risk of developing cervical cancer. Current estimates indicate approximately 100,000 new cases of cervical cancer are diagnosed each year and 30,000 deaths occur annually due to cervical cancer in China. It is believed mortality due to cervical cancer has been increasing in China. In response, China has increased efforts to screen more women, especially in rural areas where the laboratory infrastructure for traditional screening tests is lagging. Because LuViva does not require a laboratory infrastructure and produces an immediate result at the point of care, it is well suited to screening women for cervical cancer in these environments.

On November 17, 2021 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that Dennis McGrath, Chief Financial Officer, will present a corporate update at the Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum on November 18, 2021, at 4:00 PM EST (Press release, Lucid Diagnostics, NOV 17, 2021, View Source [SID1234595748]). For more information on the conference, visit View Source

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On November 17, 2021 Abintus Bio, Inc. (Abintus), a company pioneering first-in-class, off-the-shelf medicines that reprogram cells directly in vivo, reported that it has entered into an agreement with Memorial Sloan Kettering Cancer Center for the use of its next generation signaling technology ("1XX") in Abintus’ In Vivo CAR-X products (Press release, Abintus Bio, NOV 17, 2021, View Source [SID1234595747]). These products have the potential to overcome the challenges of ex vivo CAR technologies and dramatically improve outcomes and access for patients with hematologic malignancies and solid tumors.

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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

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"Having the opportunity to directly reprogram the innate and adaptive immune cell subsets with retroviral vectors, while also extending CAR immune cell function and persistence with 1XX, is an advantage for Abintus’ approach and has the potential to establish potent anti-tumor immune responses," said Michel Sadelain, M.D., Ph.D., MSK’s Director of the Center for Cell Engineering and inventor of 1XX signaling technology. "I look forward to our continued support as these products advance towards clinical investigation."

1XX signaling technology is designed to improve the persistence of chimeric antigen receptor (CAR)-engineered cells by sustaining cellular effector functions without exhaustion. To date, 1XX CARs have demonstrated superior preclinical activity compared to conventional CAR technologies in certain hematologic and solid tumors including B-cell malignancies, mesothelioma, ovarian cancer, and breast cancer. 1XX CARs are currently under clinical evaluation in multiple cancers. In Vivo CAR-X products are designed to simultaneously target both adaptive and innate immune effector cells, including active T cells and Natural Killer (NK) cells, to produce a potent and durable immune response against hematologic malignancies and solid tumors, and improve patient outcomes and access.

"For in vivo reprogramming to have a profound impact, it will require safe and well tolerated gene delivery and functional expression as well as manufacturing that can scale to meet the patient need," said Malcolm Brenner, M.D., Professor at Baylor College of Medicine, Director of the Center for Cell and Gene Therapy at the Baylor College of Medicine, Texas Children’s Hospital, and Houston Methodist Hospital and advisor. "Abintus’ retroviral technology is an ideal platform for in vivo reprogramming because it addresses these key criteria, and has a compelling precedent for safety, tolerability and proof of principle in patients with intravenous administration. Adding 1XX signaling technology further strengthens Abintus’ differentiated approach."

Abintus’ initial products targeting hematologic and solid tumors are poised to enter clinical evaluation as early as 2023.

"One of the most exciting and impactful areas of research is the reprogramming of cells directly inside a patient. Inspired by nature, Abintus’ in vivo reprogramming technology is designed to empower patients with a diverse team of living drugs that can launch a coordinated attack against their cancer," said Nicholas A. Boyle, Ph.D., CEO and cofounder of Abintus. "The insights gained from our historical observations with in vivo reprogramming in patients, combined with 1XX technology and our commercial-ready manufacturing process, positions our company with the knowhow, technology and experience to make in vivo genetic medicines a reality for patients."