Market Newsdesk

• Submission has been made for review under the accelerated approval pathway 

LEXINGTON, Mass., April 19, 2021 (GLOBE NEWSWIRE) — Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The BLA has been submitted for the accelerated approval of balstilimab, Agenus’ anti-PD-1 antibody, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and includes data from its pivotal Phase 2 single-arm clinical trial, presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. These clinical data, along with preclinical data, suggest that balstilimab demonstrates differentiated features from other anti-PD-1 antibodies.

“Women with recurrent or metastatic cervical cancer have a very poor prognosis and limited treatment options. Data suggest balstilimab may bring benefit to patients beyond what is available in this disease setting today,” said Jennifer Buell, PhD, President and Chief Operating Officer at Agenus. “This submission also marks a significant step in our transition to a commercial company and the advancement of our oncology combination strategy.”

The balstilimab BLA submission is based on an update to data presented at the ESMO Virtual Congress 2020 and published in an Oncogene editorial, which demonstrate that balstilimab shows potential differentiation from other anti-PD-1 antibodies. This updated dataset includes maturation of late patient responses, with the overall data showing response rates of 20% in PD-L1 positive tumors, 15% in all tumors (PD-L1 positive and negative), and a median duration of response of 15.4 months.

“We expect that the potential approval of balstilimab will enable us to better pursue our oncology combination strategy for our own extensive pipeline of agents as well as for existing and future partner products,” said Steven O’Day, MD, Chief Medical Officer at Agenus. “In particular, we hope to use this potential approval to allow us to rapidly proceed with our anti-CTLA-4 combination strategy, which we believe can add significantly to the benefit provided by our anti-PD-1 agent. There are currently limited treatment options available for recurrent or metastatic cervical cancer patients, and our vision is to bring effective treatments to these patients.”

In April 2020, the FDA granted Fast Track designation for balstilimab in recurrent or metastatic cervical cancer based on its potential to provide benefit to patients with a serious condition and unmet medical need.

A global, randomized, Phase 3 confirmatory clinical trial designed to support global registration is planned.

About Cervical Cancer

Nearly 14,000 women are expected to be diagnosed with invasive cervical cancer in the United States this year and more than 4,000 are expected to die. Cervical cancer remains one of the leading causes of cancer death in women globally, annually killing more than 300,000 women worldwide.¹ Despite advances in routine medical examinations and HPV vaccines, cervical cancer remains prevalent. When left undetected, recurrent or metastatic cervical cancer often develops, for which there are limited treatment options and a low chance of survival. Current therapies for recurrent or metastatic cervical cancer are limited to a small subset of patients with limited benefit.

About balstilimab

Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Balstilimab is currently in clinical trials as monotherapy and in combination with Agenus’ anti-CTLA-4, zalifrelimab, in an ongoing Phase 2 study for recurrent/metastatic cervical cancer.

About Agenus


Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer. The Company’s vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its AgenTus Therapeutics subsidiary), and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

Forward-Looking Statements


This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding future clinical trials, potential clinical benefit of our products, and future product development plans for balstilimab alone and in combination with other agents. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Contact


Agenus Investor Relations

Jan Medina, CFA
Agenus
781-674-4490
[email protected]

Agenus Media Relations

Kimberly Ha
KKH Advisors
917-291-5744
[email protected]

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¹   https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660

Company Completes Capital Structure Cleanup, Including Removal of All Variable-Rate Convertible Notes and Paydow
n of Decade-Old Debt at Significant Discount

Gaithersburg, MD, April 19, 2021 (GLOBE NEWSWIRE) — mPhase Technologies, Inc. (OTC: XDSL) (“mPhase” or the “Company”), a leading technology driven development company that creates and commercializes solutions that impact everyday people, today announced that it reached an agreement to pay off $784,000 of legacy debt at a significant discount to current value.

The judgement settlement agreement, reached with John Fife (dba St. George Investors), represented $784,000 of debt on the balance sheet and was settled for a one-time payment of $235,000.

“We are pleased to have fortified our balance sheet through the elimination of this decade-old debt, as well as all prior variable-rate convertible notes,” said Anshu Bhatnagar, Chief Executive Officer of mPhase Technologies. “Our recent capital structure cleanup protected our shareholders from significant dilution while currently preserving our cash for high-value, near-term operational initiatives.

“These efforts have served to strengthen our financial position to ensure we can continue to innovate and work towards creating sustainable, long-term value for our shareholders. I look forward to providing our shareholders with an update in the short-term on our refined business strategy in 2021 and beyond.”

About mPhase Technologies

mPhase Technologies (OTC: XSDL) is a technology driven, innovative development company that creates and commercializes products and applications that impact everyday people. The Company is assembling industry-leading teams specializing in artificial intelligence, machine learning, software, consumer engagement, and other advanced technologies. Additional information can be found at the mPhase website, www.mphasetech.com. Please follow us on twitter: @mPhase_Tech for the latest updates.

Safe Harbor Statement

This press release contains certain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of the words “could,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “may,” “continue,” “predict,” “potential,” “project” and similar expressions that are intended to identify forward-looking statements. All forward-looking statements speak only as of the date of this press release. You should not place undue reliance on these forward-looking statements. Although we believe that our plans, objectives, expectations and intentions reflected in or suggested by the forward-looking statements are reasonable, we can give no assurance that these plans, objectives, expectations or intentions will be achieved. Forward-looking statements involve significant risks and uncertainties (some of which are beyond our control) and assumptions that could cause actual results to differ materially from historical experience and present expectations or projections. Actual results to differ materially from those in the forward-looking statements and the trading price for our common stock may fluctuate significantly. Forward-looking statements also are affected by the risk factors described in the Company’s filings with the U.S. Securities and Exchange Commission. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.

Investor Relations Contact

Brian Prenoveau
Managing Director
MZ Group – MZ North America
(561) 489-5315
[email protected]
www.mzgroup.us

WASHINGTON, April 19, 2021 (GLOBE NEWSWIRE) — Witt O’Brien’s, LLC, a subsidiary of SEACOR Holdings Inc. (“SEACOR”), has now partnered with over 80 state and local governments in support of their COVID-19 relief efforts. These include six states and territories, as well as cities and counties across the United States.  

“We thank our clients for the trust they have placed in our team to help them operationalize approximately $8 billion in federal funding under the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act, the Coronavirus Relief Fund, the Emergency Rental Assistance Program, and the American Rescue Plan,” said Tim Whipple, CEO of Witt O’Brien’s. “Our shared goal is to deliver this emergency assistance to those in need across the country as quickly and efficiently as possible.”

“The recently enacted $1.9 trillion American Rescue Plan is unprecedented in scale and scope and offers state and local governments opportunities to fuel both short-term response and long-term economic recovery,” said Jonathan Hoyes, Senior Managing Director of Witt O’Brien’s Government Solutions. “However, navigating the complexity of funding sources and regulatory requirements presents a significant challenge for resource-constrained and overburdened staff at all levels of government.”

Hoyes continued, “We support our clients through every stage of the process, from needs assessment to program design, management, and implementation, including compliance and staff augmentation. Collaboratively, we build comprehensive and strategic programs that result in the greatest community and individual impact.”

Witt O’Brien’s COVID-19 support includes:

• Identification, integration, and maximization of funds from a variety of federal, state, local, private, and philanthropic sources
• Strategic advisory services and outcome-based program design
• Federal grants management and compliance
• Design and turnkey implementation of emergency rental assistance programs
• Planning and implementation of vaccination and testing programs
• Emergency assistance for small business
• Food security and supply chain stabilization

* * * * *

About Witt O’Brien’s

Witt O’Brien’s is the world leader in crisis and emergency management. We help protect our government and corporate clients by preparing for all types of business disruption. If disaster strikes, we deploy in a matter of hours to help clients respond and recover as quickly as possible. Over the last two decades, we have helped all levels of government respond to health crises, including Avian Flu, H1N1, Ebola, Zika, and now COVID-19. We have also supported emergency operations and long-term recovery following every major U.S. natural disaster, assisting with the administration of over $50 billion in federal aid.  Witt O’Brien’s is a subsidiary of SEACOR Holdings Inc. To learn more about us, please visit wittobriens.com. 

About SEACOR Holdings


SEACOR Holdings Inc.
 is a diversified holding company with interests in domestic and international transportation and logistics, crisis and emergency management, and clean fuel and power solutions.  

SHANGHAI, China, April 19, 2021 (GLOBE NEWSWIRE) — ECMOHO Limited (“ECMOHO” or the “Company”; Nasdaq: MOHO), a leading integrated solution provider in the non-medical health and wellness market in China, today announced that it has signed a memorandum of understanding (“MoU”) with Royal Danish Consulate General to introduce high-quality Danish products to Chinese consumers.

The cooperation aims to broaden ECMOHO’s partnership with Royal Danish Consulate General and is a crucial milestone for online commerce between China and Denmark. Under the MoU, the parties will explore different collaboration opportunities, including that ECMOHO will provide support for Danish companies to enter the Chinese consumer market through its various e-commerce channels, while the Royal Danish Consulate General will assist local companies to understand and optimize business in the vast Chinese consumer market by leveraging integrated services related to healthcare products and consumer-centric solutions offered by ECMOHO and platform service offered by JD Health.

“We are confident that we will enable Chinese consumers to benefit from the premium and organic products that Danish companies can offer,” the Company’s CEO, Zoe Wang, said. “China is a very promising, but also a challenging market for many Danish companies. With the development of CRM and consumer insights driven by big data, we help our partners better understand Chinese consumers and engage with them more effectively through precise targeting and positioning insights.”

The Consul General of Royal Danish Consulate General, Jakob Linulf, said, “We expect greater trade opportunities for Danish companies. The Danish pavilion plans to launch more than 30 brands selling high-quality and healthcare related products.”

Safe Harbor Statements

This news release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “target,” “going forward,” “outlook” and similar statements. Such statements are based upon management’s current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, such as the Company’s partnership with the Royal Danish Consulate General, the Company’s expectations regarding demand for and market acceptance of products under the Royal Danish Consulate General and the effectiveness of the Company’s targeted marketing of products of under the Royal Danish Consulate General, all of which are difficult to predict and many of which are beyond the Company’s control, which may cause the Company’s actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.

About ECMOHO Limited

ECMOHO is a leading integrated solution provider in the non-medical health and wellness market in China. The Company acts as the bridge between brand owners and Chinese consumers by marketing and distributing health supplements and food, mother and child care products, personal care products, household healthcare equipment and other health and wellness products. Through over eight years of operation, ECMOHO has built an ecosystem where Chinese consumers are provided with customized health and wellness solutions that include quality products and trustworthy content.

For more information, please visit http://ir.ecmoho.com/.

For investor and media inquiries, please contact:

ECMOHO Ltd.

Investor Relations

Email: [email protected] 

TORONTO, April 19, 2021 (GLOBE NEWSWIRE) — Further to its press release dated April 12, 2021, Ayurcann Holdings Corp. (CSE: AYUR) (the “Company” or “Ayurcann”), is pleased to announce that it has oversubscribed and upsized its non-brokered private placement (the “Offering”) due to strong investor demand. The Company now anticipates that the Offering will be completed for gross proceeds of not less than $550,000.00, consisting of not less than 2,910,053 units (“Units”) at a price of $0.189 per Unit. Each Unit is comprised of one common share of the Company (a “Common Share”) and one half of one Common Share purchase warrant (a “Warrant”). Each Warrant is exercisable to acquire one Common Share at an exercise price of C$0.38 per Common Share for a period of 36 months from the date of closing of the Offering (the “Closing Date”), scheduled for April 22, 2021. The Units will have a hold period of four months and one day from the date of issuance.

Ayurcann CEO Igal Sudman commented: “We are very pleased with the demand we are seeing for the Offering. The feedback we have received to date is showing that our business is resonating with investors. We’re looking forward to closing the offering and proceeding with the planned Phase 2 build out, which will help greatly increase our facility’s capacity.”

As previously stated, certain insiders of the Company may participate in the Offering. The Company may pay a commission in cash equal to 6% of the value of select proceeds raised under the Financing, specifically excluding any funds raised from insiders.

The Company will use the gross proceeds of the Offering for their Pickering facility Phase 2 expansion, which, when such expansion is complete, is estimated to increase the Company’s annual extraction capacity from 200,000 kgs to 300,000 kgs, and increase the fulfillment capabilities of cannabis 2.0 and 3.0 products from approximately 1 million units annually to approximately 2.5 million units annually.

For further information, please contact:

Igal Sudman, Chairman, Chief Executive Officer and Corporate Secretary
Ayurcann Holdings Corp.
Tel: 416-720-6264
Email: [email protected]

Investor Relations:

Ryan Bilodeau
Tel: 416-910-1440
Email: [email protected]

About Ayurcann Holdings Corp.:
Ayurcann is a leading post-harvest solution provider with a focus on providing and creating custom processes and pharma grade products for the adult use and medical cannabis industry in Canada. Ayurcann is focused on becoming the partner of choice for leading Canadian cannabis brands by providing best-in-class, proprietary services including ethanol extraction, formulation, product development and custom manufacturing.

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Certain statements included in this press release constitute forward-looking information or statements (collectively, “forward-looking statements”), including those identified by the expressions “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “may”, “should” and similar expressions to the extent they relate to the Company or its management. The forward- looking statements are not historical facts but reflect current expectations regarding future results or events. This press release contains forward looking statements, including but not limited to statements relating to the Company’s expansion plans and future production capacity. These forward-looking statements are based on current expectations and various estimates, factors and assumptions and involve known and unknown risks, uncertainties and other factors.

Forward-looking statements are not guarantees of future performance and involve risks, uncertainties and assumptions which are difficult to predict. Factors that could cause the actual results to differ materially from those in forward-looking statements include, but are not limited to, failure to obtain regulatory approval, ability to increase production at the Company’s facilities, the continued availability of capital and financing, and general economic, market or business conditions. Forward-looking statements contained in this press release are expressly qualified by this cautionary statement. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Although such statements are based on management’s reasonable assumptions, there can be no assurance that the statements will prove to be accurate or that management’s expectations or estimates of future developments, circumstances or results will materialize.
Although the Company has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, Further, there may be others that cause results not to be as anticipated, estimated or intended and such changes could be material. 

Public health crises, including the ongoing novel coronavirus (COVID-19) pandemic, could have significant economic and geopolitical impacts that may adversely affect the Company’s business, financial condition and/or results of operations.  

The Company assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances unless required by law. Readers should not place undue reliance on the Company’s forward-looking statements.