Sigyn Therapeutics™ Reports Results of Pilot Study to Address Inflammatory CytoVesicles

Sigyn Therapy™ is a Candidate to Treat Life-Threatening Inflammatory Conditions That Are Not Addressed with Drug Therapies

SAN DIEGO, Jan. 06, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Sigyn Therapeutics, Inc. (OTCMarkets: SIGY), a medical technology company whose focus is the treatment of life-threatening inflammatory conditions precipitated by Cytokine Storm Syndrome (the Cytokine Storm), today announced the results of an in vitro pilot study that successfully modeled the ability of Sigyn Therapy™ to address CytoVesicles that transport inflammatory cytokine cargos in the bloodstream.

Cytokine Storm Syndrome is an excessive response of the immune system that is induced by infectious and non-infectious conditions. A hallmark indicator of Cytokine Storm Syndrome is the excessive or uncontrolled release of pro-inflammatory cytokines, which can lead to multiple organ failure and cause death. The annual market opportunity to address Cytokine Storm related indications exceeds $20 billion and includes sepsis, the most common cause of hospital deaths worldwide. Virus-induced Cytokine Storm Syndrome is a leading cause of death resulting from severe SARS-CoV-2 (COVID-19) infections.

Sigyn Therapy is a proprietary blood purification technology designed to overcome the limitations of previous drug and device candidates to treat acute inflammatory conditions. Incorporated within Sigyn Therapy is a cocktail of adsorbent components with unique binding and capture characteristics to optimize the broad-spectrum depletion of inflammatory targets from the bloodstream. These targets include pro-inflammatory cytokines, endotoxin and CytoVesicles (extracellular vesicles that transport inflammatory cytokine cargos) that participate in concert with freely circulating cytokines to further escalate the Cytokine Storm. CytoVesicles are an important yet previously elusive target as they can be 20-60 times larger than cytokines themselves.

In the in vitro pilot study, 104nm liposomes were utilized as a model system to assess the ability of Sigyn Therapy’s adsorbent components to deplete CytoVesicles from human blood plasma. After a two-hour interaction with Sigyn’s adsorbent components, liposome concentrations in human blood plasma were reduced ~90%. Previously published studies have validated liposomes as a model for the isolation of extracellular vesicles from blood based on the similarity of their size and structural characteristics.

“When we designed Sigyn Therapy, we envisioned a device that could be broadly deployed by the medical community, yet also have expansive first-in-industry capabilities that offer to improve patient outcomes,” stated Jim Joyce, Chairman and CEO of Sigyn Therapeutics. “When considering our previous report that Sigyn Therapy™ clears both endotoxin and inflammatory cytokines from human blood plasma, the observation from our CytoVesicle pilot study further reinforces the potential for our vision to become a therapeutic reality.”

Sigyn Therapy is a single-use device designed for use on the established infrastructure of dialysis and CRRT machines already located in hospitals and clinics worldwide. On December 1, 2020, the Company reported the results of an in vitro study that validated the ability of Sigyn Therapy to simultaneously reduce the presence of endotoxin and relevant pro-inflammatory cytokines, which included Interleukin-1 Beta (IL-1B), Interleukin-6 (IL-6) and Tumor Necrosis Factor alpha (TNF-a). Endotoxin (lipopolysaccharide or LPS) is a potent mediator implicated in the pathogenesis of sepsis and septic shock. The dysregulated over-production of IL-1B, IL-6 and TNF-a can lead to organ failure and cause death.

An objective of the study was to rebalance elevated cytokine levels and optimize the elimination of endotoxin from human blood plasma. The study was conducted in triplicate over four-hour time periods with a pediatric version of Sigyn Therapy. Average reduction of endotoxin load peaked at 83% during the studies. The average reduction of IL-1B was 69%, IL-6 reduction was 59% and TNF-a reduction was 57% during the four-hour studies.

The resulting data from each of these studies will be incorporated into an Investigational Device Exemption (IDE) that Sigyn Therapeutics plans to submit to the United States Food and Drug Administration (FDA) in 2021.

About Sigyn Therapeutics

Sigyn Therapeutics™ is a development-stage therapeutic technology company headquartered in San Diego, California USA. Our focus is directed toward a significant unmet need in global health; the treatment of life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome and not addressed with an approved therapy. Our mission is to save lives.

Sigyn Therapy™ is a novel blood purification technology designed to mitigate cytokine storm syndrome through the broad-spectrum depletion of inflammatory targets from the bloodstream. Cytokine storm syndrome is the hallmark of sepsis, which is the most common cause of in-hospital deaths and claims more lives each year than all forms of cancer combined. Virus induced cytokine storm (VICS) is associated with high mortality and is a leading cause of SARS-CoV-2 (COVID-19) deaths. Other therapeutic opportunities include, but are not limited to bacteria induced cytokine storm (BICS), acute respiratory distress syndrome (ARDS) and acute forms of liver failure, such as hepatic encephalopathy.

To learn more, visit www.SigynTherapeutics.com or www.SigynTherapy.com

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties. All statements contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “could,” “will,” “plan,” “intend,” “anticipate,” “approximate,” “expect,” “potential,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about Sigyn’s future financial performance, the impact of management changes, any proposed organizational restructuring, results of operations, capital resources to fund operations; statements about Sigyn’s expectations regarding the capitalization, resources and ownership structure of the combined company; statements about the potential benefits of the transaction; the expected completion and timing of the transaction and other information relating to the transaction; and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that Sigyn makes due to a number of important factors, including (i) the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect Sigyn’s business and the price of the common stock of Sigyn, (ii) the failure to satisfy of the conditions to the consummation of the transaction, (iii) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement, (iv) risks related to the ability to realize the anticipated benefits of the transaction, including the risk that the businesses will not be integrated successfully, (v) the effect of the announcement or pendency of the transaction on Sigyn’s business relationships, operating results and business generally, (vi) risks that the proposed transaction disrupts current plans and operations, (vii) risks related to the combined entity’s ability to up-list to a national securities exchange, (viii) risks related to the combined entity’s access to existing capital and fundraising prospects to fund its ongoing operations, (ix) risks related to diverting management’s attention from Sigyn’s ongoing business operations, (x) other business effects, including the effects of industry, market, economic, political or regulatory conditions, future exchange and interest rates, and changes in tax and other laws, regulations, rates and policies, and (xi) risks related to an inability to manufacture Sigyn Therapy, risks related to the clinical advancement of Sigyn Therapy with regulatory agencies, and no assurance that Sigyn Therapy will be proven to be a safe and efficacious treatment for any condition. The forward-looking statements in this press release represent Sigyn’s views as of the date of this press release. Sigyn anticipates that subsequent events and developments may cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing Sigyn’s views as of any date subsequent to the date of this press release.

Contact Sigyn Therapeutics, Inc.

Jim Joyce
Chairman, CEO
(619) 368-2000
jj@sigyntherapeutics.com

Source: Sigyn Therapeutics, Inc.

Avivagen Inc. Announces Results for Fiscal Year Ending October 31, 2020

Ottawa, ON /Business Wire/ December 16, 2020 / — Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen” or the “Company”) today reported its audited financial results for the fiscal year ended October 31, 2020. Unless otherwise noted, all figures are in Canadian currency.

“By all measures, Avivagen achieved considerable regulatory, customer, corporate and financial success in 2020,” said Kym Anthony, President and Chief Executive Officer, Avivagen Inc. “We’ve secured record breaking orders for OxC-beta from customers in established markets and received regulatory approval in key markets in Asia and South America. The successes achieved this year position Avivagen very strongly for continued growth worldwide, as we grow recurring order sizes and add new customers and partners in important feed production markets around the globe.”

Highlights from Avivagen’s fiscal 2020 include:

Regulatory Milestones

• Secured approval for OxC-betaTM Livestock in Malaysia on December 5, 2019. Malaysia had an estimated total annual feed production of 4.8 million metric tonnes in 2019.
• Signed agreement with COFCO Biotech on December 19, 2019 to support approval process efforts in China. COFCO is a leading supplier of agri-products to the Chinese market, with more than $17.5 billion in annual sales in 2018.
• Secured approval in Brazil on June 24, 2020. Brazil is the world’s third largest feed production market, and a key exporter to regions such as Europe and China that have implemented bans against the use of antibiotics in livestock feed.
• Secured first order in Malaysia on December 12, 2019, only a week after receiving regulatory approval in the country.
• Secured first order in Mexico, by Industrias Melder, on March 25, 2020.
• Secured new sales of OxC-betaTM Livestock in Taiwan and Thailand on April 2, 2020. Avivagen followed those sales with the Company’s largest sales order to date – a three tonne order by UNAHCO in the Philippines – less than a week later.
• Mexico-based customer, Industrias Melder placed orders totaling two tonnes by May 20, 2020, following the positive results of two tests conducted by a key dairy farm client.
• Secured first order for 125kg from Look Chemicals, Avivagen’s distribution partner in Brazil, on August 12, 2020.
• Finalized record ten tonne order of OxC-beta from Industrias Melder on September 28, 2020, commencing early 2021, as well as new orders from Tesistan and Prolea in Mexico on October 6, 2020. Avivagen also joined Mexico-based industry associations, ANFACA and AMEPA at the same time, further connecting with the feed production communities across key regions in Mexico.
• Secured record four tonne order from UNAHCO on October 13, 2020, marking the largest order to date from the Philippines. As a result of a typhoon which occurred in the region following the order, two tonnes of the order were shipped during Fiscal 2020, with the other two tonnes shipped in November 2020.
• Received repeat and growing orders from Fwusow, one of Taiwan’s leading feed producers and integrators, for the use of OxC-beta in their pet food.
• Completed the first sale of OxC-beta for use in layer hens, resulting in increased egg production and accolades from the producer.
• Completed preparations for the launch of a human dietary health supplement in the US. The dietary supplement is set to launch via e-commerce within the next few weeks.

Financial and Corporate Milestones

• Secured private placements of $1.25mm and $1.75mm on January 3 and January 27, 2020 respectively.
• Listed on the OTCQB® Venture Market on January 8, 2020, helping to expand Avivagen’s investor presence in the United States.
• Launched Dr. Tobias Dog Chews with Mimi’s Rock Corp. on Amazon.com and DrTobias.com on January 23, 2020.
• Received positive results from New Zealand livestock dairy trail for sub-clinical mastitis on February 24, 2020, which extends the further use cases of OxC-betaTM Livestock.
• Published a scientific paper “The effects of maternal supplementation with fully oxidised ?-carotene on the reproductive performance and immune response of sows, as well as the growth performance of nursing piglets” in the British Journal of Nutrition on August 18, 2020.

Fiscal 2020 Financial Results

The Company’s Audited Financial Statements for the year ended October 31, 2020 and the accompanying Management’s Discussion and Analysis have been filed on the System for Electronic Document Analysis and Retrieval and are available via its website (www.sedar.com). The financial information for the year ended October 31, 2020 should be read in conjunction with the Company’s Audited Financial Statements as well as its Management’s Discussion and Analysis for the year ended October 31, 2020.

The Company reported revenues of $1,177,857 ($977,451 in the year ending October 31, 2019) and a comprehensive loss of $(4,751,287) for the year ended October 31, 2020. This compares to a comprehensive loss in the year ending October 31, 2019 of $(4,836,420). As at October 31, 2020, the Company reported total assets of $2,176,142 (current assets of $1,781,800), total liabilities of $6,943,752, and shareholders’ deficit of ($4,767,610).

Significant financing inflows in the fiscal year totalled $3,750,000. This consisted of a private placement equity financing of $3,000,000 and a debt financing of $750,000 all raised within the confines of a volatile and challenging market.

About Avivagen

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications. By unlocking an overlooked facet of ?- carotene activity, a path has been opened to safely and economically support immune function, thereby promoting general health and performance in animals. Avivagen is a public corporation traded on the TSX Venture Exchange under the symbol VIV and on the OTCQB Exchange in the U.S. under the symbol VIVXF, and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada and Charlottetown, Prince Edward Island. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock

Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Taiwan, New Zealand, Thailand, Mexico, Brazil, Australia and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements

This news release includes certain forward-looking statements that are based upon the current
expectations of management. Forward-looking statements involve risks and uncertainties
associated with the business of Avivagen Inc. and the environment in which the business
operates. Any statements contained herein that are not statements of historical facts may be
deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”,
“appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”,
“likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”,
“would” and similar expressions. Statements set out in this news release relating to the future
plans of Avivagen’s customers and the potential for additional and/or increased orders from such
customers, Avivagen’s expectations as to growth of its branding in certain jurisdictions,
continued distribution and acceptance of Avivagen’s technology, anticipated growth in demand
for Avivagen’s products, the potential for Avivgen’s products to be commercialized in human
applications, the anticipated date of fulfillment for the order described, the possibility for OxCbeta
™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health
support in certain livestock applications where antibiotics are precluded and the size of market
opportunities are all forward-looking statements. These forward-looking statements are subject
to a number of risks and uncertainties that could cause actual results or events to differ
materially from current expectations. For instance, the order described may not result in new
orders for Avivagen’s products, the customer plans may change due to many reasons, demand
for Avivagen’s products may not continue to grow and could decline, Avivagen’s brand
recognition may not increase as anticipated or could be impacted by negative events, Avivagen’s
products may not gain market acceptance or regulatory approval in new jurisdictions or for new
applications, including human applications, and may not be widely accepted as a replacement
for antibiotics in livestock feeds, new market access may not occur in the timeline or manner
expected by Avivagen, timing of fulfillment of the order may be delayed beyond current
expectation for a number of reasons which would push fulfillment and recognition of revenues
for this order into a future quarter and the market opportunities may not be as large as Avivagen
anticipates, in each case due to many factors, many of which are outside of Avivagen’s control.
Readers are referred to the risk factors associated with the business of Avivagen set out in
Avivagen’s most recent management’s discussion and analysis of financial condition available at
www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither 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
release.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6
Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6
Head Office Phone: 613-949-8164
Website: www.avivagen.com

SOURCE: Avivagen