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 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 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR"), in connection with Merck’s pending acquisition of Acceleron Pharma Inc. (Nasdaq: XLRN) expired at 11:59 p.m., Eastern Time, on Nov. 16, 2021 (Press release, Merck & Co, NOV 17, 2021, View Source [SID1234595735]).

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As previously announced on Oct. 12, 2021, Merck commenced, through a subsidiary, Astros Merger Sub, Inc., a cash tender offer to purchase all outstanding shares of common stock of Acceleron, for $180 in cash, without interest and less any required tax withholding. The expiration of the HSR waiting period satisfies one of the conditions necessary for the consummation of the tender offer. Consummation of the tender offer remains subject to other conditions described in the tender offer statement on Schedule TO filed with the U.S. Securities and Exchange Commission (the "SEC") on Oct. 12, 2021, including the tender of shares representing at least a majority of the total number of Acceleron’s outstanding shares.

Astros Merger Sub, Inc. is extending the tender offer, which was previously scheduled to expire at 5:00 p.m., Eastern Time, on Nov. 18, 2021, until 5:00 p.m., Eastern time, on Nov. 19, 2021 in order to accommodate tendering of Acceleron shares traded on Nov. 17, 2021. The tender offer may be extended further in accordance with the merger agreement and the applicable rules and regulations of the SEC. All other terms and conditions of the tender offer will remain unchanged during the extended period. The acquisition is expected to close in the fourth quarter of 2021.

The Depositary for the tender offer is Computershare Trust Company, N.A., c/o Voluntary Corporate Actions, P.O. Box 43011, Providence, RI 02940-3011. The Depositary has advised Merck that, as of 5:00 p.m., Eastern time, on Nov. 16, 2021, the last business day prior to the announcement of the extension of the tender offer, approximately 11,980,722 shares of Acceleron had been validly tendered and received, and not validly withdrawn, pursuant to the tender offer, representing approximately 19.6% of Acceleron’s outstanding shares. Stockholders who have already tendered their shares do not need to retender such shares or take any other action as a result of the extension of the tender offer.

The Information Agent for the tender offer is Innisfree M&A Incorporated, 501 Madison Avenue, 20th floor, New York, NY 10022. The tender offer materials may be obtained at no charge by directing a request by mail to Innisfree M&A Incorporated or by calling toll free at (877) 800-5195, and may also be obtained at no charge at the website maintained by the SEC at www.sec.gov.

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 Orange Grove Bio, a preclinical drug investment and development firm, and the University of Pittsburgh reported the establishment of a collaboration designed to advance the development and commercialization of novel therapeutics by supporting the translation of scientific discoveries made by researchers at the University of Pittsburgh (Press release, Orange Grove Bio, NOV 17, 2021, View Source [SID1234633191]). The newly established partnership will aim to cultivate the Pittsburgh biotech landscape by increasing entrepreneurship, education, and scientific translation of promising technologies. These efforts will be focused in the areas of oncology and autoimmune and inflammatory diseases.

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"University of Pittsburgh innovators have a strong track record of achieving impact for their research through commercial translation," said Joe Havrilla, Associate Vice Chancellor for Innovation and Entrepreneurship. "This new collaboration with Orange Grove Bio will allow us to further our commercialization efforts and we look forward to the positive impact it will have for our faculty and students and ultimately for patients."

Under terms of the partnership, Orange Grove Bio will provide commercialization guidance and support to the University of Pittsburgh Innovation Institute, an internship program for the university’s Ph.D. students, and educational seminars for primary investigators and researchers at the university. Additionally, as part of these activities, Orange Grove Bio’s head of chemistry, William H. Miller, Ph.D., has joined the University of Pittsburgh’s external advisory board for novel technologies.

"Researchers at the University of Pittsburgh are engaged in a wide range of cutting-edge research that has the potential to meaningfully impact human health," said Dr. Miller. "At Orange Grove, we want to do our part to support these ongoing research efforts and further develop the local biotech environment to enable the development and commercialization of these discoveries."

In addition to working closely with the technology transfer office and supporting educational initiatives, Orange Grove Bio will increase its on-the-ground presence by onboarding new team members from the Pittsburgh area, who will perform critical scientific and business functions.

Orange Grove Bio’s mission is to develop new therapeutic options for patients by harnessing the significant research potential found in universities across the United States. Orange Grove Bio fosters strong relationships with technology transfer offices outside of the traditional medical technology hubs of Boston and San Francisco. Collectively, Orange Grove Bio’s team possesses more than one hundred years of drug development and company creation experience, allowing it to build and finance innovative programs from the research and development stage to clinical trials.

"We believe that the University of Pittsburgh and its talented researchers are well positioned to serve as a hotbed for the incubation of innovative drug development companies capable of delivering the ground-breaking therapies of tomorrow," said Marc Appel, Orange Grove Bio’s chief executive officer. "We are committed to fostering and supporting this rich scientific ecosystem through collaboration with the University of Pittsburgh, academic researchers, and investors to drive the commercialization of novel therapies for patients."