BALTIMORE–(BUSINESS WIRE)–Akers Biosciences, Inc. (Nasdaq: AKER), with its proposed merger partner MyMD Pharmaceuticals, Inc. (“MyMD”), a clinical stage pharmaceutical company committed to extending healthy lifespan by focusing on developing two therapeutic platforms, today announced new data from a study conducted by Eurofins Discovery Phenotypic Center of Excellence.
MYMD-1 is being developed to treat autoimmune and age-related diseases, including extending the human lifespan, and has been shown to be effective in regulating the immune system in preclinical studies.
The findings of the Eurofins Discovery study indicate the potential of MYMD-1 to limit the fibrotic biology associated with idiopathic pulmonary fibrosis (IPF). Hallmark activities of MYMD-1 included inhibition of transforming growth factor-beta (TGF-beta), a driver for fibrosis, and of tumor necrosis factor (TNF), associated with inflammation. This dual pattern of anti-fibrotic and anti-inflammatory activities are consistent with the potential for MYMD-1 to be developed as a therapeutic candidate for fibrosis-related diseases.
Fibrotic disorders are implicated in nearly 45% of all deaths in the developed world, and may involve multiple physiological systems including the skin, liver, kidney, heart and lungs. In particular, IPF has an insidious, relentless and chronic course, with a median survival of two to five years. Thus there is a great need to develop new and effective therapeutics for treating patients.
“Nearly 100,000 people in the United States have IPF, and although cases continue to climb, there is still a significant unmet need in treatment options for this chronic disease,” said Chris Chapman, M.D., President and Chief Medical Officer of MyMD. “MYMD-1 continues to demonstrate broad utility and capability to inhibit inflammation in preclinical data, which is linked to myriad diseases including IPF. This study stirs hope for those affected by the disease and gives MYMD-1 an additional path forward.”
The study was completed using the BioMAP Phenotypic Screening and Profiling Platform from Eurofins Discovery. This platform addresses the need for translationally relevant, predictive in vitro models of human disease, including fibrosis. The BioMAP Fibrosis Panel models complex human tissue and disease biology driving the aberrant inflammation involved in fibrosis and wound healing, and preserves the complex multicellularity of organs such as the lung and kidney with their cell-cell physical communications and signaling events that occur to influence disease. The panel provided information on MYMD-1 mechanistic signatures, identification of unexpected activities, competitor analysis, guidance on non-cytotoxic concentrations and more.
“The activities in this study immediately caught our attention as they spoke to impacts on fibrosis disease biology that remain an unmet clinical need,” said Alison O’Mahony, Ph.D, Vice President of Translational Biology at Eurofins Discovery. “We have learned over the years from testing both approved fibrosis drugs and failed candidates, that efficacy requires not only anti-fibrotic impacts, but also anti-inflammatory activities. During the study, MYMD-1 inhibited both aspects of fibrosis biology. We were also able to determine well-tolerated treatment concentrations as part of the study.”
“There are many adverse outcomes from inappropriate inflammation and dysregulated wound healing responses, including IPF,” said Adam Kaplin, M.D., Ph.D, Chief Scientific Officer for MyMD Pharmaceuticals. “We selected Eurofins to run the study knowing the credibility and breadth of their platform, and were pleased to see the readouts specifically showed inhibition of disease biology among key biomarkers associated with IPF, especially through Eurofins’ human phenotypic screening platform, allowing us to see patient-specific cell activity.”
MyMD plans to move forward in testing combinations of MyMD-1 with approved fibrosis drugs to determine how the agents interact to impact disease biology of IPF. For more information on MyMD, visit mymd.com.
About MyMD Pharmaceuticals, Inc.
MyMD is a clinical stage pharmaceutical company committed to extending healthy lifespan by focusing on developing two therapeutic platforms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immunometabolic system to control TNF-α and other pro-inflammatory cytokines. MYMD-1 is being developed to treat autoimmune diseases, including those currently treated with non-selective TNF-α blocking drugs, and aging and longevity. SUPERA-1R is a drug platform based on a novel (patent pending) synthetic derivative of cannabidiol (CBD) that targets numerous key receptors including CB2 and opioid receptors and inhibits monoamine oxidase. SUPERA-1R is being developed to address the rapidly growing CBD market, that includes FDA approved drugs and CBD products not currently regulated as a drug. For more information, visit www.mymd.com.
About Akers Biosciences Inc.
Akers Biosciences is pursuing rapid development and manufacturing of a COVID-19 vaccine candidate in collaboration with Premas Biotech PVT Ltd.
About Eurofins – the global leader in bio-analysis
Eurofins is Testing for Life. Eurofins is a global leader in food, environment, and pharmaceutical product testing. It is also one of the market leaders in testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing.
With over 50,000 staff across a network of more than 800 laboratories in over 50 countries, Eurofins’ companies offer a portfolio of over 200,000 analytical methods.
Eurofins Shares are listed on Euronext Paris Stock Exchange.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No public offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Important Additional Information Will be Filed with the SEC
In connection with the proposed transaction between Akers and MyMD, Akers has filed with the SEC a registration statement on Form S-4 that includes a preliminary joint proxy statement of Akers and MyMD that also constitutes a prospectus of Akers and the definitive joint proxy statement statement/prospectus will be mailed to shareholders of Akers and MyMD. Akers and MyMD also plan to file other relevant documents with the SEC regarding the proposed transaction. AKERS URGES INVESTORS AND STOCKHOLDERS TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT AKERS, THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors and shareholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Akers with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. In addition, investors and shareholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Akers with the SEC by contacting Investor Relations by mail at Akers Biosciences, Inc., Attn: Investor Relations, 1185 Avenue of the Americas, 3rd Floor, New York, New York USA 10036. Investors and stockholders are urged to read the proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction.
Participants in the Solicitation
Akers and MyMD, and each of their respective directors and executive officers and certain of their other members of management and employees, may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about Akers’ directors and executive officers is included in Akers’ Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 25, 2020, as amended on October 21, 2020, and the proxy statement for Akers’ 2020 annual meeting of stockholders, filed with the SEC on July 29, 2020. Additional information regarding these persons and their interests in the transaction will be included in the proxy statement relating to the transaction when it is filed with the SEC. These documents can be obtained free of charge from the sources indicated above.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this communication regarding matters that are not historical facts are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Akers and MyMD undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, risks relating to the completion of the merger, including the need for stockholder approval and the satisfaction of closing conditions; the cash balances of the combined company following the closing of the merger; the ability of Akers to remain listed on the Nasdaq Capital Market in connection with the merger; and expected merger-related cash outlays, including the timing and amount of those outlays. Risks and uncertainties related to MyMD that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates, the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates, the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy.
New factors emerge from time to time and it is not possible for us to predict all such factors, nor can we assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks, as well as other risks associated with the combination, are more fully discussed in the proxy statement/prospectus that is included in the registration statement that was filed with the SEC in connection with the proposed transaction. Additional risks and uncertainties are identified and discussed in the “Risk Factors” section of Akers’ Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Akers and MyMD as of the date of this release. Neither Akers nor MyMD undertakes any obligation to update such forward- looking statements to reflect events or circumstances after the date of this release.