Zenith and Newsoara Biopharma Announce Expanded Licensing and Investment

CALGARY, Alberta, Nov. 15, 2021 (GLOBE NEWSWIRE) — Zenith Capital Corp. (“Zenith” or the “Company”) announced today that Zenith Epigenetics Ltd. (“Zenith Epigenetics”), a wholly-owned subsidiary of Zenith Capital, has entered into a licensing agreement with Newsoara Biopharma Co., Ltd. (“Newsoara”) for Zenith Epigenetics’ lead compound, ZEN-3694, in Asia excluding Middle East and North Africa (“MENA”), India, and ten Eurasian countries (the “Territories”). Under the terms of the agreement, Newsoara will have the rights to develop, market, and distribute ZEN-3694 for all indications in the Territories. Zenith will receive an upfront payment of US$3.5 million, sales-based milestones and single digit royalties.

Concurrent with the execution of the license agreement, Newsoara has entered into a subscription agreement to subscribe for 1.5 million units at a price of US$1.00 per unit, and Newsoara also agreed to subscribe for an additional 10 million units of Zenith by way of completing ZEN-3694 development programs with a budget of $10 million over the next 15 months. Each unit (“Unit”) shall be comprised of one common share and one-half of a common share purchase warrant. Each whole warrant shall be exercisable into one common share at US$1.00 for a period of two years from the date of the subscription agreement.

“We are very pleased to further expand our partnership with Newsoara to introduce the therapeutic potential of ZEN-3694 to additional Asian markets,” stated Donald McCaffrey, President and CEO of Zenith. “ZEN-3694 is a leading and differentiated BET inhibitor now having shown clinical proof of concept in two solid tumor indications with significant unmet need, metastatic castration-resistant prostate cancer and metastatic triple negative breast cancer. This additional financing will support advancing these programs towards registration enabling studies for these indications in collaboration with our partner Newsoara.”

About Newsoara

Newsoara is a biotech company based in Shanghai, China with research laboratories in the Suzhou BioBAY focusing on novel drug research and development to address unmet medical needs in patients with oncology, autoimmune, respiratory, and metabolic diseases. Newsoara has licensed development and commercialization rights to ZEN-3694 for China, Hong Kong, Taiwan, Macau and Asia excluding MENA (Middle East and North Africa), India and ten Eurasian countries.

About Zenith

Zenith Capital Corp. is a biotechnology investment company originally spun out of Resverlogix Corp. (TSX: RVX) in 2013. Zenith Epigenetics Ltd., a wholly-owned subsidiary of Zenith Capital Corp., is a clinical stage biotechnology company focused on the discovery and development of novel therapeutics for the treatment of cancer and other disorders with significant unmet medical need. Zenith Epigenetics is developing various novel combinations of BET inhibitors with other targeted agents. The lead compound, ZEN-3694, is in clinical development for:

  1. Metastatic castration-resistant prostate cancer (“mCRPC”) in combination with androgen receptor inhibitor, enzalutamide (XTANDI), with Astellas and Newsoara as collaborators.
  2. Triple Negative Breast Cancer (“TNBC”) in combination with the PARP inhibitor TALZENNA with Pfizer as a collaborator.
  3. Androgen receptor independent mCRPC in combination with immune checkpoint inhibitor KEYTRUDA and XTANDI with University of California, San Francisco as a collaborator.
  4. Ovarian cancer in combination with immune-checkpoint inhibitors, nivolumab and ipilimumab in collaboration with the National Cancer Institute.
  5. Nut midline carcinoma in combination with chemotherapy in collaboration with the National Cancer Institute.

For further information, please contact:

Investor Relations & Communications                

Zenith Epigenetics
Phone: 587-390-7865
Email: info@zenithepigenetics.com
Website: www.zenithepigenetics.com

This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. In particular, this news release includes forward looking information relating to the license and subscription agreements with Newsoara, the introduction of ZEN-3694 by Newsoara to Asian markets and the potential role of ZEN-3694 in the treatment of cancer and other disordersOur actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our most recent MD&A which are incorporated herein by reference and are available through SEDAR at www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. Zenith disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Junshi Biosciences and Coherus Announce Toripalimab Granted Orphan Drug Designation in the United States for Esophageal Cancer

SHANGHAI, China and REDWOOD CITY, Calif., Nov. 15, 2021 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (“Coherus”, Nasdaq: CHRS) announced today that the United States Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (ODD) for toripalimab for the treatment of esophageal cancer. Orphan drug designation is granted to drugs and biologics intended to treat rare diseases with a patient population less than 200,000 in the U.S. The designation provides incentives to advance development and commercialization of rare disease drugs.

Esophageal cancer (“EC”) is a malignant tumor originating in the inner lining of the esophagus. Esophageal squamous cell carcinoma (“ESCC”) and adenocarcinoma are the two main subtypes of esophageal cancer. EC is rare in the United States, with approximately 19,000 newly diagnosed cases and 15,000 deaths annually, according to estimates from the American Cancer Society. The prognosis of patients with advanced EC is poor, with five-year survival rates of less than 20%.

In September, Junshi Biosciences and Coherus announced results of the Phase 3 clinical trial, JUPITER-06, a randomized, double blind, placebo-controlled study evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic ESCC. The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival (PFS) and overall survival (OS) for patients treated with the toripalimab and chemotherapy combination, compared to chemotherapy alone. In 2022, Junshi Biosciences and Coherus are planning to submit a biologics license application (“BLA”) supplement to the FDA for toripalimab in combination with platinum-based chemotherapy for the first-line treatment of advanced or metastatic ESCC. A BLA for toripalimab for advanced recurrent or metastatic nasopharyngeal carcinoma is currently under priority review by the FDA with a target action date of April 2022.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (“NPC”) after failure of at least two lines of prior systemic therapy. In April, the NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs, one for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC, and the other for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma, were accepted by the NMPA for review in February and July 2021, respectively.

In the United States, the FDA has granted priority review for the toripalimab BLA for the treatment of recurrent or metastatic NPC, an aggressive head and neck tumor which currently has no FDA-approved immuno-oncology treatment options. Earlier, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for esophageal cancer, NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.

About Coherus BioSciences

Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients’ lives and to deliver significant savings to the health care system. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

UDENYCA® is a trademark of Coherus BioSciences, Inc.

Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

Humira® is a registered trademark of AbbVie Inc.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 45 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in 15 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ ability to generate cash flow from its UDENYCA® business; Coherus’ and Junshi Biosciences’ ability to co-develop toripalimab, and Coherus’ ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus’ ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the expected filing of a BLA supplement seeking approval for toripalimab for ESCC in 2022; the ability for ex-US clinical trial data from a single country to support an approval by the FDA; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma, esophageal squamous cell carcinoma, lung cancer, or any indication; Coherus’ and Junshi Biosciences’ plans to file additional toripalimab BLAs with the FDA over the next three years for other clinical indications; Coherus’ plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus’ ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus’ regulatory filings; the risk of FDA review issues; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and nine months ended June 30, 2021, filed with the Securities and Exchange Commission on November 8, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended September 30, 2021 are not necessarily indicative of our operating results for any future periods.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300

Solebury Trout
Bob Ai
bai@soleburytrout.com
+ 1 646-389-6658

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

Coherus Contact Information:
IR Contact:
McDavid Stilwell
Coherus BioSciences, Inc.
IR@coherus.com

Media Contact:
Cheston Turbyfill
Real Chemistry
Cturbyfill@coherus.com

CoImmune, Inc. Appoints Ed Baracchini, PhD, Chairman of the Board of Directors

DURHAM, N.C., Nov. 15, 2021 (GLOBE NEWSWIRE) — CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, today announced the appointment of Dr. Ed Baracchini as chairman of the Company’s board of directors.

“As a member of the CoImmune board of directors, Dr. Baracchini has provided strong counsel and guidance on many important issues in corporate development and strategy,” stated Dr. Charles Nicolette, chief executive officer. “In his new role as chairman, his depth of experience in both biotechnology and fundraising will provide new levels of insight and guidance as we seek to advance our novel pipeline of cell-based immunotherapies directed at severe diseases including acute lymphoblastic leukemia and advanced renal cell carcinoma. We are also grateful to Dr. Byung Geon Rhee for his service as chair of our board during a formative period in the growth of CoImmune.”

Dr. Baracchini has extensive experience in structuring and negotiating research and development partnerships, mergers and acquisitions, and licensing agreements and has raised a considerable amount of money in private and public capital markets. He has personally negotiated more than 80 business transactions with multinational pharmaceutical firms, biotechnology companies, and prominent universities. He is currently a member of the board of directors at INmune Bio (NASDAQ: INMB) and 4D Pharma (AIM: DDDD) (NASDAQ: LBPS). From 2020-2021 he was chief business officer at Imago Biosciences and from 2010 to 2018 he was chief business officer at Xencor Inc. He has also held leadership roles in business development and corporate strategy at Metabasis, Elitra Pharmaceuticals, Warner-Lambert, Agouron Pharmaceuticals and Ionis Pharmaceuticals. He earned his BS in microbiology at University of Notre Dame, a PhD in molecular and cell biology at University of Texas, and his MBA at University of California, Irvine.

“The Co-Immune CAR-CIK platform shows strong potential to deliver a new generation of immune-oncology therapies that offer significant advantages over earlier-generation CAR-T therapies,” said Dr. Baracchini. “I look forward to continuing to work with the outstanding board and management team at CoImmune as we plan for many pivotal business and clinical development milestones in the months and years ahead.”

About CoImmune, Inc.
CoImmune is a privately held, clinical stage immuno-oncology company that will redefine cancer treatment using best-in-class cellular immunotherapies. Our allogeneic CAR-CIK technology platform for liquid and solid tumors is a variation on CAR-T therapy that promises enhanced efficacy with greatly reduced toxicity. Our autologous RNA-loaded dendritic cell technology for solid tumors uses amplified total tumor mRNA to program highly engineered dendritic cells to generate immune responses against neoantigens without the need to identify them.

For more information visit www.coimmune.com

Investor Contact:
Lori Harrelson
Chief Financial Officer
CoImmune, Inc.
lharrelson@coimmune.com

Media Contact:
Adam Daley
Berry & Company Public Relations
bberry@berrypr.com
212.253.8881

Digihost’s October Bitcoin Production Value Increases 1,486% Over October 2020 and up 56% From September

TORONTO, Nov. 15, 2021 (GLOBE NEWSWIRE) — Digihost Technology Inc. (“Digihost” or the “Company”) (TSXV: DGHI; Nasdaq: DGHI), an innovative North American based Bitcoin self-mining company, is pleased to provide an unaudited Bitcoin (“BTC”) production update for the month ended October 31, 2021. All amounts are expressed in USD unless otherwise indicated. The Company is also pleased provide a reminder that trading on the Nasdaq Capital Market is expected to commence on the date hereof, under the symbol “DGHI.”

Corporate Highlights for October 2021:

  • Produced 41.84 BTC during the month, increasing total holdings to 494.08 BTC representing a fair market value of approximately $30.3 million as of October 31, 2021.
  • Total Ethereum (“ETH”) holdings of 1,000.89 ETH representing a fair market value of approximately $4.3 million as at October 31, 2021.
  • Total digital asset inventory value consisting of BTC and ETH of approximately $34.6 million at the end of October.
  • Cash on hand at October 31st was approximately $9.7 million, and total cash and digital asset holdings was approximately $44.3 million.
  • Year-to-date deposits on equipment and infrastructure targeted to be installed in Q4 2021 and H1 2022 pertaining to the Company’s core business of approximately $30.8 million.
  • During October, the Company received 4,932 new, technologically advanced, high-performance M30 Bitcoin miners (the “Miners”), with over 1,000 additional Miners in transit to the Company’s data center.
  • The Company’s current hashrate is approximately 400PH and is expected to increase to approximately 500PH by the end of November, representing an increase of approximately 150% since September of 2021.

Bitcoin Mining Update

For the ten-month period ended October 31, 2021, the Company’s mining fleet produced 390.09 BTC, with production broken down as follows:

  • Quarter 1, 2021: 105.26 BTC
    • January: 33.70
    • February: 35.02
    • March: 36.54
  • Quarter 2, 2021: 109.97 BTC
    • April: 37.52
    • May: 34.26
    • June: 38.19
  • Quarter 3, 2021: 133.02 BTC
    • July: 51.28
    • August: 44.07
    • September: 37.67
  • Quarter 4, 2021: 41.84 BTC
    • October: 41.84

Year-Over-Year Monthly Comparison

The Company mined approximately 30.10 more BTC in October of 2021, compared to October 2020, representing an increase of approximately 256%. Using the October 31, 2021 and the October 31, 2020 closing BTC prices (per CoinDesk) plus the increase in BTC mined in October 2021, the value of the Company’s BTC mined in October 2021 increased by approximately $2.4 million, or 1,486% over October 2021.

Figure 1. Year-over-year Monthly BTC Production

Oct-20 Oct-21 MoM Increase
Mined BTC 11.74 41.84 30.10
Approximate BTC value $13,781 $61,319 $47,538
Value $161,789 $2,565,587 $2,403,798

Month-Over-Month Comparison

The Company mined an additional 4.17 BTC during October 2021 compared to September 2021, representing an increase of 11%. Based on October 31, 2021and September 30, 2021 closing BTC prices plus the increase in BTC mined in October, the value of the Company’s BTC mined in October increased by approximately $0.9 million, or 56%, month over month.

Figure 2. Month-over-month BTC Production

Sep-21 Oct-21 MoM Increase
Mined BTC 37.67 41.84 4.17
Approximate BTC value $43,791 $61,319 $17,528
Value $1,649,725 $2,565,587 $915,980

Management Commentary

Michel Amar, the Company’s CEO, stated: “The increase in BTC production in October 2021 signifies continued operational success for Digihost and demonstrates the preliminary incremental mining rewards being generated as result of the arrival and deployment of new advanced machines at our data center. With additional miners expected to arrive in the weeks ahead, we will focus on optimizing our mining fleet as older machines are cycled out of production and replaced with cutting-edge models, which should enable us to substantially grow our hashrate and continue our strategy of increasing monthly coin production.”

About Digihost Technology Inc.

Digihost is a growth-oriented blockchain technology company primarily focused on Bitcoin mining. Through its self-mining operations and joint venture agreements, the Company is currently hashing at a rate of approximately 400PH with plans to expand to a hashrate of 3.6 EH by the end of 2022.

For further information, please contact:

Digihost Technology Inc.
www.digihost.ca
Michel Amar, Chief Executive Officer
Email: michel@digihostblockchain.com

Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

Forward-Looking Statements
Except for the statements of historical fact, this news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking information”) that are based on expectations, estimates and projections as at the date of this news release and are covered by safe harbors under U.S. and Canadian securities laws. Forward-looking information in this news release includes information about hashrate expansion, diversification of operations, potential further improvements to profitability and efficiency across mining operations, potential for the Company’s long-term growth, and the business goals and objectives of the Company. Factors that could cause actual results, performance or achievements to differ materially from those described in such forward-looking information include, but are not limited to: continued effects of the COVID19 pandemic may have a material adverse effect on the Company’s performance as supply chains are disrupted and prevent the Company from operating its assets; the ability to establish new facilities for the purpose of research & development; a decrease in cryptocurrency pricing, volume of transaction activity or generally, the profitability of cryptocurrency mining; delivery of mining rigs for hosting may not be realized in the number anticipated, or at all, and resulting hashing power may materially differ from that anticipated; further improvements to profitability and efficiency may not be realized; the digital currency market; the Company’s ability to successfully mine digital currency on the cloud; the Company may not be able to profitably liquidate its current digital currency inventory, or at all; a decline in digital currency prices may have a significant negative impact on the Company’s operations; the volatility of digital currency prices; and other related risks as more fully set out in the Annual Information Form of the Company and other documents disclosed under the Company’s filings at www.sedar.com. The forward-looking information in this news release reflects the current expectations, assumptions and/or beliefs of the Company based on information currently available to the Company. In connection with the forward-looking information contained in this news release, the Company has made assumptions about: the current profitability in mining cryptocurrency (including pricing and volume of current transaction activity); profitable use of the Company’s assets going forward; the Company’s ability to profitably liquidate its digital currency inventory as required; historical prices of digital currencies and the ability of the Company to mine digital currencies on the cloud will be consistent with historical prices; and there will be no regulation or law that will prevent the Company from operating its business. The Company has also assumed that no significant events occur outside of the Company’s normal course of business. Although the Company believes that the assumptions inherent in the forward-looking information are reasonable, forward-looking information is not a guarantee of future performance and accordingly undue reliance should not be put on such information due to the inherent uncertainty therein. Except as expressly required by applicable securities laws, the Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, changed circumstances or future events or for any other reason.

Adagio Therapeutics Provides Update for ADG20 COVID-19 Antibody Program and Reports Third Quarter 2021 Financial Results

FDA Feedback Supports Planned Emergency Use Authorization (EUA) Submission for ADG20 for Prevention of COVID-19; Interim Clinical Data Package from EVADE Prevention Trial to Support EUA Submission Expected in Second Quarter 2022

Enrollment Progressing in ADG20 STAMP Trial for Treatment of COVID-19; Planned Interim Efficacy Analysis Expected in Second Quarter 2022 to Support Potential EUA Submission

WALTHAM, Mass., Nov. 15, 2021 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., (Nasdaq: ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today provided an update on its lead COVID-19 antibody program, ADG20, and reported third quarter 2021 financial results. ADG20 is an investigational monoclonal antibody product candidate designed to provide broad and potent neutralizing activity against SARS-CoV-2, including variants of concern, for the prevention and treatment of COVID-19.

“ADG20 continues to be the only monoclonal antibody in late-stage development that has the potential to offer a unique combination of potency, breadth of neutralization across known SARS-CoV-2 variants of concern as well as additional SARS-like viruses with pandemic potential, and durable protection against COVID-19 for up to one year. Further, our single injection delivery avoids the inconveniences associated with IV administration or multiple injections,” said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. “The world continues to face a host of challenges in fully addressing the COVID-19 crisis. Alternatives or supplements to vaccines for the prevention of COVID-19 are needed for immunocompromised individuals and those who remain hesitant to receive a vaccine or to vaccinate their children. Certain patient populations may not be ideal candidates for emerging oral treatment options due to adherence concerns, comorbidities or possible drug interactions. Based on its combined attributes, ADG20 has the potential to be a differentiated alternative for the prevention and treatment of COVID-19 that may address the needs of these populations, and our commitment to its advancement is unwavering.”

“We’ve made significant progress over the course of 2021, and 2022 is set to be a landmark year for Adagio as we prepare for potential EUA submissions for ADG20 for the prevention and treatment of COVID-19,” said Tillman Gerngross, Ph.D., co-founder and chief executive officer of Adagio. “We recently received clear feedback from the FDA on a strategy to submit an EUA for ADG20 for the prevention of COVID-19, and have initiated efforts to expand our clinical program to additional patient subsets, including immunocompromised individuals and children. Our commercial-readiness efforts are well underway and with a strong balance sheet, we are ready to move quickly to enable access to individuals in need of COVID-19 prevention and treatment options, if authorization and/or approval is granted.”

ADG20 COVID-19 Program Updates

Prevention
Adagio continues to enroll adult and adolescent participants in its ongoing, global Phase 3 EVADE clinical trial evaluating ADG20 as a prevention for COVID-19 in both the pre-exposure and recent exposure settings.

  • Adagio has received feedback from the U.S. Food and Drug Administration (FDA) on a data package needed and a pathway for an EUA submission for the pre-exposure prevention of COVID-19
  • Adagio anticipates that the data package to support an EUA for ADG20 will be available in the second quarter of 2022 followed by expected submission to the FDA in the third quarter of 2022
  • Adagio plans to add a new cohort in EVADE to evaluate ADG20 as a preventative option in immunocompromised individuals, with enrollment expected to begin in the first quarter of 2022
  • Adagio also plans to initiate a trial evaluating ADG20 as a vaccine supplement
  • Following discussion with the FDA, Adagio has aligned on a plan to evaluate ADG20 as a preventative option in the pediatric population, with a trial in individuals between two and 11 years of age expected to be initiated by mid-year 2022

Treatment
Adagio continues to enroll patients in its ongoing, global Phase 2/3 STAMP clinical trial evaluating ADG20 as a treatment for COVID-19.

  • Adagio is planning to modify the trial design in order to expand the at-risk patient population eligible for enrollment in STAMP
  • Based on current enrollment, Adagio anticipates reaching the Phase 2 independent data monitoring committee evaluation in the first quarter of 2022 and the interim efficacy analysis in the second quarter of 2022 to potentially support a subsequent EUA submission

Recent ADG20 Data Presentations at ISIRV-WHO and IDWeek2021

  • New in vitro data demonstrated retained neutralizing activity of ADG20 against a diverse panel of circulating SARS-CoV-2 variants, including the newly emerged Lambda, Mu and Delta plus variants. Notably, findings showed that ADG20 demonstrated potent neutralizing activity against all SARS-CoV-2 variants of concern tested, including those with reduced susceptibility to mAb products currently available under EUA or in late-stage development.
  • Data from a six-month evaluation in Adagio’s Phase 1 healthy volunteer trial of ADG20 confirmed the extended half-life of ADG20, which approached 100 days based on data from the 300 mg intramuscular dose that was given as a single injection. In addition, an exploratory analysis showed that 50% serum virus neutralization titers at six months after a 300 mg intramuscular dose of ADG20 were similar to observed peak titers with the mRNA-1273 vaccine and exceeded those achieved with the AZD1222 vaccine series. ADG20 was well-tolerated with no study drug-related adverse events (AEs), serious AEs, or injection-site or hypersensitivity reactions reported through a minimum of three months follow-up across all cohorts.
  • To support dose selection for Adagio’s global Phase 2/3 STAMP and EVADE clinical trials, the company modified an existing quantitative systems pharmacology whole-body physiologically-based pharmacokinetic (QSP/PBPK) model to better characterize the PK of extended half-life mAbs in serum and key sites of viral replication in the respiratory tract. Adagio’s model adequately a priori predicted the observed ADG20 serum PK in non-human primates (NHPs) and humans. The model was further optimized based on data from Adagio’s Phase 1 clinical trial and then applied for dose selection for STAMP and EVADE, ultimately informing selection of the 300 mg intramuscular dose for the trials.

Intellectual Property

On October 29, 2021, the United States Patent and Trademark Office mailed a notice of allowance to the company for a patent application that will provide patent protection for ADG20 in the U.S.

Third Quarter 2021 Financial Results

  • As of September 30, 2021, Adagio had cash, cash equivalents and marketable securities of $666.3 million, which are expected to support the company’s current operating plans into 2023.
  • Research & development expenses including in-process research and development for the third quarter of 2021 were $49.4 million.
  • Selling, general & administrative expenses for the third quarter of 2021 were $11.1 million.
  • Net loss for the third quarter was $60.4 million, or $0.98 per share.

About ADG20
ADG20, an investigational monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is advancing through global clinical trials for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2. ADG20 was designed and engineered to possess high potency and broad neutralization activity against SARS-CoV-2 and additional clade 1 sarbecoviruses by targeting a highly conserved epitope in the receptor binding domain. ADG20 was further engineered to provide an extended half-life for durable protection. ADG20 has demonstrated potent neutralizing activity against the original SARS-CoV-2 virus, all known SARS-CoV-2 variants of concern and additional SARS-like viruses in preclinical studies. ADG20 is administered in clinical trials by a single intramuscular injection. To date, ADG20 has been well-tolerated in a Phase 1 trial with no safety signals identified through a minimum of three months follow-up across all cohorts. ADG20 has not been approved for use in any country, and safety and efficacy have not yet been established.

About Adagio Therapeutics
Adagio (Nasdaq: ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, including COVID-19 and influenza. The company’s portfolio of antibodies has been optimized using Adimab’s industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with the potential for a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio’s portfolio of SARS-CoV-2 antibodies includes multiple non-competing, broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers to support the completion of clinical trials and initial commercial launch, ensuring the potential for broad accessibility to people around the world. For more information, please visit www.adagiotx.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the timing, progress and results of our preclinical studies and clinical trials of ADG20, including the timing of our planned EUA submissions, initiation, modification and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; our ability to obtain and maintain regulatory approvals for, our product candidates; our ability to identify patients, including in specific populations, with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our expectations regarding the scope of any approved indication for ADG20; and the benefits of our product candidates to patients; our manufacturing capabilities and strategy; and our ability to successfully commercialize our product candidates. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, the impacts of the COVID-19 pandemic on our business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, and the uncertainties and timing of the regulatory approval process. Other factors that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in Adagio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and in Adagio’s future reports to be filed with the SEC, including Adagio’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. Such risks may be amplified by the impacts of the COVID-19 pandemic. Forward-looking statements contained in this press release are made as of this date, and Adagio undertakes no duty to update such information except as required under applicable law.

Contacts:
Media Contact:
Dan Budwick, 1AB
Dan@1abmedia.com

Investor Contact:
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

ADAGIO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share amounts)

September 30,
2021
December 31,
2020
Assets
Current assets:
Cash and cash equivalents $ 478,269 $ 114,988
Marketable securities 188,053
Prepaid expenses and other current assets 13,833 2,394
Total current assets 680,155 117,382
Other non-current assets 6,115
Total assets $ 686,270 $ 117,382
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable $ 17,564 $ 8,153
Accrued expenses 35,485 4,919
Total current liabilities 53,049 13,072
Early-exercise liability 8 11
Total liabilities 53,057 13,083
Commitments and contingencies
Convertible preferred stock (Series A, B and C) $0.0001 par value; no shares authorized, issued and outstanding at September 30, 2021; 12,647,934 shares authorized, issued and outstanding at December 31, 2020; aggregate liquidation preference of $0 and $169,900 at September 30, 2021 and December 31, 2020, respectively 169,548
Stockholders’ equity (deficit):
Preferred stock:
Undesignated preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2021; no shares authorized at December 31, 2020; no shares issued and outstanding at September 30, 2021 and December 31, 2020
Common stock, $0.0001 par value; 1,000,000,000 shares authorized at September 30, 2021; 150,000,000 shares authorized at December 31, 2020; 111,251,660 shares issued and outstanding at September 30, 2021; 28,193,240 shares issued and 5,593,240 shares outstanding at December 31, 2020 5 1
Treasury stock, at cost; no shares and 22,600,000 shares at September 30, 2021 and December 31, 2020, respectively (85 )
Additional paid-in capital 842,272 154
Accumulated other comprehensive income 3
Accumulated deficit (209,067 ) (65,319 )
Total stockholders’ equity (deficit) 633,213 (65,249 )
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) $ 686,270 $ 117,382

ADAGIO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands, except share and per share amounts)

Three Months
Ended
September 30,
Three Months
Ended
September 30,
Nine Months
Ended
September 30,
Period from
June 3, 2020
(Inception) to
September 30,
2021 2020 2021 2020
Operating expenses:
Research and development(1) $ 45,366 $ 7,251 $ 114,465 $ 7,299
Acquired in-process research and development(2) 4,000 39,915 7,500 39,915
Selling, general and administrative 11,052 842 21,853 892
Total operating expenses 60,418 48,008 143,818 48,106
Loss from operations (60,418 ) (48,008 ) (143,818 ) (48,106 )
Other income (expense):
Interest income 48 80
Other expense (5 ) (10 )
Total other income (expense), net 43 70
Net loss (60,375 ) (48,008 ) (143,748 ) (48,106 )
Other comprehensive income (loss)
Unrealized gain on available-for-sale securities, net of tax 3 3
Comprehensive loss $ (60,372 ) $ (48,008 ) $ (143,745 ) $ (48,106 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.98 ) $ (25.98 ) $ (7.06 ) $ (7.55 )
Weighted-average common shares outstanding, basic and diluted 61,297,086 1,847,826 20,346,771 6,375,000

(1)   Includes related-party amounts of $1,826 and $2,261 for the three and nine months ended September 30, 2021, respectively, and $291 for both the three months ended September 30, 2020 and for the period from June 3, 2020 (inception) to September 30, 2020.
(2)   Includes related-party amounts of $4,000 and $7,500 for the three and nine months ended September 30, 2021, respectively, and $39,915 for both the three months ended September 30, 2020 and for the period from June 3, 2020 (inception) to September 30, 2020.

International Handball Federation partners with Sportradar Integrity Services

Sportradar’s proven fraud detection services to help protect the integrity of global handball competition

BASEL, Switzerland & ST GALLEN, Switzerland, Nov. 15, 2021 (GLOBE NEWSWIRE) — The International Handball Federation (IHF) and Sportradar Integrity Services – a global supplier of sport integrity solutions and partner to over 100 sports federations and leagues – have today entered a multi-year agreement for the monitoring of global handball events. Sportradar Integrity Services is a unit of Sportradar (NASDAQ: SRAD) (“Sportradar” or “the Company”), the leading global sports technology company.

Under the agreement, Sportradar Integrity Services will draw upon its substantial experience and expertise – having monitored global betting markets for more than 16 years – to provide bet monitoring via its Universal Fraud Detection System (UFDS) for IHF events, including both the men’s and women’s World, Junior and Youth World Championships, as well as the IHF Super Globe. Sportradar considers bet monitoring essential to every sport and believes that the service should be available to help protect all levels of competition.

The UFDS is an advanced and proven bet monitoring system that has been independently assessed and verified by recognized experts in the field of sports betting and integrity. Betting patterns are analysed for abnormalities by a global team of qualified integrity experts, and any suspicious matches are subsequently reported to partners, allowing critical visibility into worldwide match-fixing. Sportradar Integrity Services have detected over 6,500 suspicious matches during the past 16 years with more than 750 of these taking place in 2021 alone.

IHF President Dr Hassan Moustafa said: “We recognize the modern-day integrity threats that face global sport, and handball is no exception. The IHF makes it a top priority to have robust measures in place to help safeguard the integrity of our major events, not just at men’s and women’s senior level, but also at youth and junior level. Sportradar have a proven track record in the field of sports integrity, and the depth of their bet monitoring capabilities will help to support our overall integrity programme in the years ahead.”

Sportradar Integrity Services Managing Director Andreas Krannich added: “We are delighted to partner with IHF to help support their integrity programme with our UFDS bet monitoring solution. We have witnessed rising integrity issues in handball over the past five years, and so we credit the vigilance shown by IHF in adding to the integrity provisions surrounding their events. At Sportradar, we are fully committed to assisting our partners’ integrity efforts and look forward to working together with the IHF to support the journey of global handball in the coming years.”

ABOUT SPORTRADAR INTEGRITY SERVICES:
Sportradar Integrity Services is a leading supplier of monitoring, intelligence, education, and consultancy solutions for sports organisations, state authorities, and law enforcement agencies to support them in the fight against match-fixing and corruption. Trusted and relied on by more than 100 sports’ governing bodies and leagues around the world and staffed with executives who have implemented integrity policies for the world’s largest sports bodies and leagues, we are firmly established as the unrivalled market leader in the field of sporting integrity.

ABOUT SPORTRADAR:
Sportradar is the leading global sports technology company creating immersive experiences for sports fans and bettors. Established in 2001, the company is well-positioned at the intersection of the sports, media and betting industries, providing sports federations, news media, consumer platforms and sports betting operators with a range of solutions to help grow their business. Sportradar employs more than 2,300 full time employees across 19 countries around the world. It is our commitment to excellent service, quality and reliability that makes us the trusted partner of more than 1,600 customers in over 120 countries and an official partner of the NBA, NHL, MLB, NASCAR, FIFA, UEFA, ICC, and ITF. We cover more than 750,000 events annually across 83 sports. With deep industry relationships, Sportradar is not just redefining the sports fan experience; it also safeguards the sports themselves through its Integrity Services division and advocacy for an integrity-driven environment for all involved.

For more information about Sportradar, please visit www.sportradar.com

Source: Sportradar Group AG

Press Contacts:
Sportradar
Sandra Lee
comms@sportradar.com

Investor Relations Contacts:
Ankit Hira or Ed Yuen
Solebury Trout for Sportradar
investor.relations@sportradar.com

Innovation Zed Announce 2022 Launch of InsulCheck DOSE Add-on Technology for Insulin Pens

InsulCheck DOSE by Innovation Zed

InsulCheck DOSE by Innovation Zed

DUBLIN, Nov. 15, 2021 (GLOBE NEWSWIRE) — Innovation Zed, developer of novel diabetes management technologies (the InsulCheck range), headquartered at NovaUCD, at University College Dublin, Ireland are delighted to announce today the arrival of the much anticipated InsulCheck DOSE technology that will be coming to market in 2022.

“It is with great excitement that we announce the arrival of our InsulCheck DOSE by Innovation Zed. As the third generation product of the InsulCheck family, this technology has been a dream of our company from its very inception and this product is the culmination of over a decade of work to support multiple daily injection (MDI) pen users. We understood the difficult challenges presented by various injection pens and in particular the difficulties in working on a technology to reliably and accurately support low-cost disposable pens. This is the reason we at Innovation Zed took an incremental approach to developing the InsulCheck DOSE product.” – said Dr Dean Minnock, CEO at Innovation Zed. “We have taken a unique approach in developing this technology by working closely with users, caregivers, software developers, medical device specialists and previous generations of InsulCheck products to design and develop a product that bolsters and supports the needs of all stakeholders” – he continued.

Innovation Zed has collaborated with SHL Medical in the development of InsulCheck DOSE. SHL Medical is a world-leading provider of drug delivery solutions and also offers design-to-build and contract manufacturing services for various medical products through its subsidiary, SHL Technologies.

What is InsulCheck DOSE?

InsulCheck DOSE is a single unit add-on device for pen injectors that automatically captures dose value dialled, injection event time stamp, temperature and mounting/unmounting events. Through Bluetooth® Low Energy (BLE) technology, InsulCheck DOSE transmits these data points to a paired companion software platform in real time for inclusion in diabetes management therapy.

“InsulCheck DOSE technology supports MDI users by enhancing their traditional injection pen and transforming it into a smart pen that can optimise their treatment and reduce the stresses caused by MDI therapy. Through this technology we are enabling every MDI user to make their existing injection pen a smart pen without having to compromise or change from their existing HMO or health service provider” – said Dr Minnock.

InsulCheck DOSE Features

The technology utilises a multi-sensor approach to accurately detect and register the actual dosage dialled and provide an injection event time stamp to log the event. The incorporated temperature sensors constantly monitor the ambient temperature of the area surrounding the injection pen, providing safety notifications to the user if the surrounding temperature may affect the drug housed inside the pen. Using an OLED display, InsulCheck DOSE provides visual information and feedback to the user, helping improve best practice procedures. A rechargeable lithium battery powers the DOSE device and is capable of operating well over 1 week at a time between charges. As a BLE enabled product, all data captured by InsulCheck DOSE is transferred in real time to a paired mobile application. If the user does not wish or is unable to remain connected with a companion software platform, InsulCheck DOSE has built-in memory to store over 40 days’ worth of injection history at a time. Through modification of the sleeve component and firmware refinement, InsulCheck DOSE can become applicable to all injection pens for various drug treatments. At launch, it will support a range of reusable and disposable injection pens on the insulin market from Novo Nordisk, Lilly and Sanofi.

“Our ability to learn, adapt and improve our technology is one of the key aspects of InsulCheck DOSE and one that separates us greatly from our competitors. The future-proof design of InsulCheck DOSE means that it can be adapted to support the various pen mechanisms in use today, whilst maintaining accuracy and reliability for the patient. Among the numerous unique features of this product is the built in Firmware Over The Air (FOTA) capability which allows continuous optimisation of the device’s firmware even when deployed in the field. That future-proofing allows InsulCheck DOSE to adapt to physical injection pen variations from the pen manufacturers and improve on device performance ‘on the go’ from real world user behaviours” – said Dr Minnock.

Value Proposition

The InsulCheck DOSE device helps patients, automatically track their daily injection and monitor treatment adherence. The intended use of InsulCheck DOSE is as a supporting component in a management ecosystem for therapy optimisation, remote monitoring and enhanced connected care. Dr Minnock explained, “InsulCheck DOSE is a disruptive technology that will revolutionise an entire market and change the lives of millions of MDI users worldwide. Innovation Zed have entered into discussions with market leaders in the diabetes management sector with the intention of finding a strategic global partner in taking this InsulCheck DOSE technology to the market. InsulCheck DOSE is an attractive offering to any organisation working in this space as it can significantly enhance their existing offering to become more competitive and command new growth and additional market share.”

Conclusion

InsulCheck DOSE enters production at the end of Q2 2022 and will be available as an FDA registered and CE marked product. Manufacturing of InsulCheck DOSE will be handled by Innovation Zed’s existing manufacturing partner SHL Technologies, a subsidiary of SHL Medical. If you wish to understand InsulCheck DOSE or any of our technology offerings in greater detail, please feel free to visit our website or reach out to us directly.

Editors Notes

Innovation Zed designs connected health solutions that support drug adherence and Condition Management. As technologies continue to evolve, it opens new and exciting possibilities for connected healthcare to deliver increased freedom and control to patients. That is why Innovation Zed is actively developing and researching new methods to improve drug adherence and optimise treatment to enable more personalised condition management. www.innovationzed.com.

Media Contact

Dean Minnock, CEO, Innovation Zed
deanm@innovationzed.com

______________

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Innovation Zed is under license. Other trademarks and trade names are those of their respective owners.

Related Images

Image 1: InsulCheck DOSE by Innovation Zed

InsulCheck DOSE is an add-on device for injection pens that captures various injection events, including dose dialled, and transmits data to a companion app via Bluetooth®

This content was issued through the press release distribution service at Newswire.com.

Attachment

.

Cambodia to end quarantine for vaccinated travellers from Nov. 15 – PM Hun Sen

PHNOM PENH, Nov 14 (Reuters) – Cambodia will stop requiring quarantine for travellers who have been vaccinated for COVID-19 starting on Monday, Prime Minister Hun Sen said on Sunday.

The prime minister made the announcement in a voice message on social media after the Southeast Asian country has required lengthy quarantine for more than 18 months.

“After seeing that people have two doses and a negative COVID test, they will be allowed to travel all over the Kingdom of Cambodia,” he said.

Hun Sen said travellers will have to show their negative test 72 hours prior to travel and have two vaccine doses. Those who are unvaccinated will be quarantined for 14 days.

Hun Sen said vaccinated foreigners and Cambodians who are in quarantine will be allowed to leave from tomorrow.

“This is a quick way to re-open the country and facilitate travel for our people. I know some of our citizens want to go abroad but are worried about coming back with quarantine required,” he said.

Cambodia has vaccinated nearly 90% of its more than 16 million people, one of Asia’s highest inoculation rates.

Source: Thai Public Broadcasting Service

US Colleges, Universities See Sharp Losses During Pandemic

The number of foreign students studying at U.S. colleges and universities sharply declined for the school year that started in September 2020. Experts attribute the decline to the COVID-19 pandemic.

A survey of almost 3,000 institutions of higher education in the U.S. showed a 15% decrease in the number of international students attending the 2020-2021 school year.

The number of new student enrollments was slashed by 45.6%.

This brings the total of enrolled international students to 914,095, the first time since the 2015-2016 academic year the number fell below the 1 million mark after a decade of swift increases.

International students comprise 4.6% of the nearly 20 million students enrolled in U.S. higher education.

The number of students from China and India continue to dominate enrollment at U.S. colleges and universities. Combined, they continue to make up more than half of all the international students in the U.S.

Students from China declined by 14.8% from the previous year to 317,299, or 34.7% of all international students.

Students from India declined by 13.2% from the previous year to 167,583, or 18.3% of all international students.

The pandemic emanated from China in December 2019. International students left the U.S. to return to their home countries for winter break, with many returning to U.S. campuses in January 2020. U.S. campuses locked down in March 2020 around spring break, and all students were sent home, went home or remained in the U.S. as colleges and universities moved classes to online learning.

The research was conducted by the Institute of International Education (IIE), headquartered in New York, and released November 15. IIE, founded in 1919, is a nonprofit organization funded by the U.S. State Department, and it focuses on “international student exchange and aid, foreign affairs, and international peace and security,” according to its website. Its mission is to “build more peaceful and equitable societies by advancing scholarship, building economies and promoting access to opportunity.”

New York University remained the top destination school for international students among all U.S. colleges and universities. New York state hosted the second-largest amount — 106,894 of the 914,095 total — after first-place California, which hosted 132,758 students. The University of Southern California moved from the third to the fourth slot – overtaken by New York City’s Columbia University – but the University of California campuses in San Diego, Los Angeles, Berkeley, Irvine and Davis were included in the top 18.

Northeastern University in Boston was the second most-popular school for international students: 15,880 of the 66,273 who attend school in Massachusetts. Another 10,646 international students attended Boston University, located nearby, among at least 10 other colleges and universities in an area known locally as the Miracle Mile.

IIE also released a more optimistic Fall snapshot that surveyed more than 860 institutions about enrollment for the school year that started in August and September 2021.

“The findings of the 2021 Fall International Student Enrollment Snapshot reflect the resilience of U.S. higher education institutions and student mobility during the COVID-19 pandemic,” IIE stated. “Higher education institutions report a 68% increase in the number of new international students enrolling for the first time at a U.S. institution in the U.S. or online from abroad, a surge from the 46% decline reported in Open Doors 2021.”

Of those 860 institutions, 70% reported an increase in new student enrollment, while 10% said enrollment was maintained and 20% reported a decrease.

As of fall 2021, 99% of colleges and universities that participated in the survey reported holding classes in person or a hybrid of in person and online. At least 65% reported having international students on campus.

Seventy-seven percent reported spending as much, if not more, on student recruitment compared to previous years.

Source: Voice of America

Chinese Students in US Reflect on COVID Chaos

Ryan Wang was among hundreds of thousands of Chinese students at U.S. colleges or universities who struggled over whether to return home to China or remain in the United States when the COVID-19 pandemic surged in the spring of 2020.

“When the pandemic started in China [months earlier], I felt lucky I was already back to the U.S. for the new semester,” Wang, a Chinese undergraduate studying economics at Columbia University in New York City, told VOA.

Unlike Wang, many international students had not returned to the United States from winter break in January 2020 and fretted that they would lose credits and tuition fees if they could not get back to school.

For Wang, the concerns centered around whether he could return home to China.

“I had to live through the fear of infection, paying over $10,000 dollars for a one-way ticket, and being scammed by fake ticket dealers before I could go home again,” he said.

Fake dealers were selling bogus tickets to international students desperate to go home after Beijing limited international carriers to one flight a week into China in April 2020. To the delight of his parents, he said, three months after U.S. colleges and universities shut down their campuses and moved all learning online, he finally made it home to Jiangsu.

“It was such a relief. Not only because I [could stop worrying] about securing tickets home, but also that I didn’t have to sanitize everything and worry about COVID-19,” he said. In Jiangsu, a province of over 80 million people in East China that includes Shanghai, there was less reported community spread from March 2020 to June 2021.

Just how many Chinese students sat out the 2020-2021 academic year in the U.S. was revealed this week by the Institute of International Education in its yearly report about international student mobility. The report said almost 3,000 U.S. colleges and universities showed a 15% decrease in overall international student attendance, and a 45.6% decrease in new student enrollment.

Among Chinese students — the largest percentage of total 914,095 international students in the U.S. — there was a 14.8% decline from the previous year to 317,299, or 34.7% of all international students. The second largest group from India, comprising 18.3% of all international students, showed a decline of 13.2%.

Engaging students far away

U.S. universities struggled to keep students on track. Like many schools, Columbia University extended its pass-fail policies, which reduced the academic stress of online learning. Wang said the university also provided office and study space in China where lockdowns were lifting, so students could stay engaged.

Others took classes at local universities through exchange programs arranged by their U.S. universities. Xinle Hou took two classes at Beijing Normal University (BNU) through a program called “go-local” through Barnard College, which is the women’s undergraduate institution affiliated with Columbia. Other universities, including New York University (NYU) and Cornell University in Ithaca, New York, arranged for their students to attend classes in China as the pandemic abated there, while infections rose in the U.S.

Online learning fail

But not everyone was so lucky. Many students were required to take classes online remotely. [[ https://www.voanews.com/a/student-union_if-its-330-am-it-must-be-time-online-class/6199331.html ]]

Hou, who had attended Barnard in New York City, described feeling burned out, and then “dystopian” from sleep deprivation, trying to attend classes at 2 a.m. or 3 a.m., and then at 8:30 in the morning.

“As I had an online class at night, I did not have much energy to actually go out during the day, which made me feel very detached from the place I was physically living in,” she said.

Florence Chen, an undergraduate student at Columbia University, told VOA that most of her classes were synchronous, meaning students worldwide attended class at the same time, regardless of their time zone. [[ https://www.voanews.com/a/student-union_why-students-go-dark-zoom-classes/6202872.html ]]

“It was truly a suffering to take classes late at night,” she lamented, adding that 3 a.m. was just too late for her.[[ https://www.voanews.com/a/student-union_students-give-online-learning-low-marks/6186962.html ]] Irene Zhang, who attended Colby College in the northeastern U.S. state of Maine, returned to China during COVID-19. She ended up taking a semester off.

“My college experience was definitely disrupted,” Irene wrote in a text. “I think COVID disconnected a lot of international students to their U.S. institutions.”

While American campuses remained in lockdown, China was opening up, students said. Some studied online and interned in person.

Chen worked a full-time internship while taking online classes in the evenings. Wang interned on weekdays and watched lecture videos intensively on weekends. Most of his online classes, he said, were offered asynchronously, or at his convenience.

“It was arguably the most productive period in my college years,” he said.

Mass return

After more than a year of closures, most American universities have called all their students back to campus. But not everyone feels secure about the pandemic.

“I still don’t feel entirely safe, but I really needed to come back and graduate, as my college does not offer remote options anymore starting this semester,” said Zhang.

“Although many COVID restrictions have been lifted and people wander around, I personally still follow the protocols, which include masking all the time indoors and outdoors, distancing wherever appropriate, eating in my own room, and sanitizing everything,” said Chen. “It’s been kind of sad that I cannot hang out with friends or explore the city since COVID-19 hit. However, I do believe that safety and well-being is my top concern and priority studying in a foreign country.”

US, or else?

After graduating from University of Maryland, Rhine Liu has started law school in Hong Kong. Although she said she thinks U.S. law schools are unparalleled in excellence, her parents want her closer to home.

“Overall, I am very glad for the opportunity to be able to spend my college life in such a culturally diverse environment,” May Ding wrote VOA. “The experience shaped me to become a global citizen with a global vision.”

For her part, Hou said she plans to stay in the U.S. and pursue a master’s of fine arts in creative writing. The U.S. has the best resources and opportunities for creative writers, she noted.

Zhang, who is looking at graduate programs in education, also plans to stay in the country as there are “some great programs” that fit her passion.

“If money is not a problem, I believe that all parents may aspire to send their kids for the best education,” Chen noted. “Studying in the U.S. indeed brings a world of opportunities.”

Source: Voice of America