November 15, 2021

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:

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

November 15, 2021

Biden, Xi video summit likely to seek ‘guardrails,’ damage control

Damage control, rather than resolution of key differences, is likely to be the main focus when U.S. president Joe Biden meets his Chinese counterpart Xi Jinping at a video summit late on Monday Washington time.

U.S. officials have indicated via media reports that the Biden administration isn’t expecting any breakthroughs, but is hoping to stop bilateral tensions — fueled by a trade war, Beijing’s threat that it may invade democratic Taiwan, and the Chinese Communist Party (CCP)’s human rights record — from escalating to a dangerous degree.

The talks look set to last for several hours and touch on the climate emergency, trade, and nuclear non-proliferation, as well as Taiwan, with U.S. officials briefing the media that Washington doesn’t want open conflict, but rather “fierce competition.”

In Beijing, Chinese foreign ministry spokesman Zhao Lijian said the relationship with the U.S. is at a “critical crossroads,” calling for dialogue and cooperation to resolve sensitive issues.

Chinese state media said Beijing’s anger over the Biden administration’s growing willingness to voice public support for Taiwan, which has never been ruled by the CCP, nor formed part of the People’s Republic of China, will likely top Beijing’s agenda at the talks.

“It is expected that the virtual meeting between the two heads of state will also give an important place to the Taiwan question which will be one of the biggest difficulties of the meeting,” the CCP-backed Global Times newspaper said in an editorial dated Nov. 14.

“The most critical and urgent [issue] is to defuse the explosive question concerning Taiwan, because the Taiwan Straits is the most likely flashpoint to trigger the confrontation between China and the U.S.,” the paper said, dismissing U.S. Secretary of State Antony Blinken’s call for “meaningful dialogue” on the matter as “hypocritical cliché and nonsense.”

It accused Taiwan’s ruling Democratic Progressive Party (DPP) under president Tsai Ing-wen as “promoting Taiwan secession,” referring to Tsai’s refusal to entertain Beijing’s territorial claims, saying the island is already a democratic, self-governing state whose 23 million people have no wish to live under the CCP’s authoritarian rule.

“Yes, the Chinese mainland has been stepping up its preparations for a military conflict across the Taiwan Straits in recent years,” the Global Times said. “Apart from making the Taiwan authorities aware that the risk of war is approaching them, is there any language in the world that can help them understand what they are doing is extremely dangerous?”

“The Taiwan question is the ultimate red line of China,” it added, calling on the U.S. to “take a step back,” to avert a strategic collision.

“Washington must understand that it has gone too far, leaving China with no way back,” it said, citing recent reports of military cooperation between the U.S. and Taiwan.

Meanwhile, Biden will tell Xi that China must “play by the rules of the road” like a responsible nation, a senior U.S. administration official told Reuters.

“This is an opportunity for President Biden to tell President Xi directly that he expects him to play by the rules of the road, which is what other responsible nations do,” the official said. “This is not a meeting where we expect deliverables to be coming out,” the official added.

Agence France-Presse quoted a U.S. official as saying: “The president will also make clear that we want to build common guardrails to avoid miscalculation or misunderstanding.”

But officials in Washington seem unwilling to comment on whether U.S. will send officials to the Beijing Winter Olympics in February 2022, amid growing calls from activists and U.S. lawmakers for a boycott on human rights grounds.

The summit also comes soon after a report from the Pentagon, which said Beijing is significantly expanding its nuclear weapons and missile programs.

‘Slim chance’ of improvement

Matsuda Yasuhiro of the University of Tokyo said the chances of any improvement in the relationship were “very slim” with Xi Jinping looking likely to extend his term in office next year, after amending the constitution to abolish presidential term limits.

He cited a CCP communiqué on party history that left out any mention of “mistakes” by late supreme leader Mao Zedong, and situates Xi as the supreme heir to a long line of autocratic Chinese leaders.

“The communiqué mentions Mao Zedong seven times, Deng Xiaoping five times, Jiang Zemin once, Hu Jintao once, and Xi Jinping 16 times,” Matsuda told RFA in a recent interview. “Basically, he elevated himself to the highest position.”

“Xi Jinping’s re-appointment in Dalian next year is basically assured,” he said.

Wang Hsin-hsien, director and professor of the Institute of East Asia Studies at Taiwan’s National Chengchi University, said Xi is unlikely to want any escalating foreign conflict ahead of the 20th Party Congress in 2022, however.

“The real wolf warrior diplomacy, or you could call it the nationalistic diplomatic line, probably ended in March [2021],” Wang said. “That was peak wolf warrior diplomacy, and its purpose was to test Biden’s limits.”

“The wolf warrior rhetoric and the nationalistic mood will diminish ahead of the 20th Party Congress,” he said. “The CCP will want to create a favorable international environment.”

Promoting an authoritarian model

Wang said Xi’s ultimate goal, however, is to export China’s authoritarian model of governance to the rest of the world.

“The main point is that he is taking a path that is totally divergent from that of the U.S., and he wants the rest of the world to follow China’s plan, too,” he said.

“The CCP is telling the story that democracy has different flavors — that’s it’s not all Coca-Cola according to [foreign minister] Wang Yi — and that … its brand of ‘full-process democracy’ is a true form of democracy,” Wang said.

“This argument has some appeal to developing countries.”

Taiwan political analyst Shih Chien-yu said one of the key indicators of Sino-U.S. relations in the months to come will be whether the U.S. boycotts the 2022 Winter Games in Beijing.

“Regardless of whether China makes concessions on Xinjiang, Tibet, Taiwan, or Hong Kong, if the U.S. Secretary of State or another official from the executive branch … is sent to the Winter Olympics, they will be turning out on parade for Xi Jinping,” Shih said.

“It’s possible that this summit may address this issue … but we may not hear the final decision until later.”

Wu Qiang, former politics lecturer at Beijing’s Tsinghua University, said China is unlikely to extend an invitation at all, given its vulnerability to criticism over its human rights record.

“If Xi were to invite Biden to the Winter Olympics … it would put him in the embarrassing position of having Biden counter it with Xinjiang or Hong Kong,” Wu said.

“And if Beijing were thinking about inviting Biden to turn the Olympics into a staged political event, then Biden could use that opportunity to talk about China’s domestic political issues.”

“I think both sides are going to want to avoid doing this at the current juncture.”

Translated and edited by Luisetta Mudie.

November 15, 2021

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

November 15, 2021

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

November 15, 2021

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.

November 15, 2021

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.