Category: Biotech News

• Bintai Kinden Corporation Berhad (www.bintai.com.my) is an investment holding company headquartered in Malaysia with operations throughout South-East Asia, China, and the Arabian Gulf Region
• Upfront development payment
• 100% funding for commercial registration of Ii-Key- SARS-CoV-2 prophylactic vaccine against COVID-19 in Malaysia
• Licensing fees upon approval
• Potential $150 million in GNBT revenues for vaccine sales in Malaysia

MIRAMAR, Fla., Aug. 18, 2020 (GLOBE NEWSWIRE) — Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) today announced that the company has signed a memorandum of understanding with Bintai Kinden Corporation of Malaysia for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine. The Ii-Key-SARS-CoV-2 vaccine is designed as a “Complete Vaccine” that has the potential to induce the T-Cell and antibody immune responses that can provide protective immunity with long-lasting immunologic memory against SARS-CoV-2 in a highly specific manner to ensure safety.

With this agreement, Bintai has agreed to pay Generex up-front development fees and back-end licensing payments, and will pay 100% of the funding required for the commercial development of the Ii-Key-CoV-2 vaccine including laboratory work, manufacturing, regulatory filings and the clinical development program for regulatory approval of the vaccine in Malaysia. Additionally, upon approval of the Ii-Key-CoV-2 vaccine in Malaysia, Generex will earn royalties on sales of the vaccine with potential revenues of up to $150 million.

Under terms of the agreement, Generex and Bintai have agreed to collaborate and have developed a strategy towards the rapid development of the Ii-Key-CoV-2 vaccine with three primary goals:

1. Streamline the Vaccine Development Process

The development program will simultaneously implement different stages of development and production, so the vaccine can be developed at a faster rate.

2. Conduct Clinical Trials Globally

Generex and Bintai agree that the development of a vaccine for COVID-19 should not be a race for high income countries, so clinical trials will be conducted in as many countries as possible to enable the best chance of finding a vaccine that is safe, effective and affordable for everyone. This multi-country approach will ensure that the efficacy of the vaccine is generalizable or suited to the native population and to further obtain commercial license for sale of Ii-Key-SARS-CoV-2 Peptide Vaccine from the Malaysia Ministry of Health and other health authorities around the world.

3. Build Global Manufacturing Capacity

Bintai and Generex agree that the vaccine manufacturing should serve not only as an essential element of a vaccination program for each country, but also as an economic stimulus, as many countries shift their focus to rebuild their economies following the inevitable economic shutdown as the battle of the global pandemic continues.

The legal contracts for the licensing and development agreements, currently being mutually drafted by the Generex and Bintai legal teams, are expected to be finalized and signed in the coming days. Generex will file an 8K report with the SEC upon signing of the official contract.

Generex CEO, Joseph Moscato said, “We are excited and proud to have Bintai as a partner to develop our Ii-Key-SARS-CoV-2 vaccine against COVID-19. Our “Complete Vaccine” has the potential to generate both a cellular (T-Cell) and humoral (antibody) response to ensure immune system memory and long-term immunity from COVID-19. Our partners in Malaysia have recognized the true potential of the Ii-Key technology to activate the T-Cell response as part of any successful coronavirus vaccine that enables long-term immunity. Further, our proprietary vaccine development process is designed using computational vaccinology and immune system screening program to identify specific target regions of the SARS-CoV-2 spike protein that can neutralize the virus without generating the off-target effects that lead to the terrible complications of COVID-19. This deal also leverages Bintai’s expertise in industrial engineering and construction to provide the manufacturing capability that can produce the billions of doses of vaccine that will be necessary to immunize a global population.”

Mr. Moscato continued, “I would like to personally thank the Bintai organization for their commitment to develop a safe, effective, and universal vaccine against COVID-19 for the benefit of Malaysia. We are optimistic that our partnership with Bintai can help to solve this COVID-19 pandemic that has ravaged the world’s health and economies.”

About Generex Biotechnology Corp.
Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

About NuGenerex Immuno-Oncology
NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines for cancer and infectious disease based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) has been spun out of Generex as a separate public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors for the treatment of cancer. NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Merck’s Keytruda®) for the treatment of triple negative breast cancer. The company has also turned its Ii-Key technology on infectious disease, responding to the coronavirus pandemic with a SARS-CoV-2 vaccine development program.

About Bintai Kinden
With over 40 years of specialist engineering and construction experience, Bintai’s unique combination of extensive regional experience and local knowledge has made them the region’s international contractor of choice. Headquartered in Malaysia, Bintai Kinden has expanded operations regionally throughout South-East Asia, China and the Arabian Gulf region.

As multi-disciplined, building and industrial service engineers and specialists, Bintai works in all the major market sectors, from commercial buildings to industrial complexes, designing, installing and commissioning systems that include the full range of engineering services.

Looking beyond today’s frontiers, Bintai Kinden is confident that it has the resources, technical expertise and progressive mindset to consolidate its position globally. The integration of research, management, marketing and sales that transcends organizational borders enables Bintai Kinden to capitalize on synergistic potential and benefits of scale.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as “expects,” “plan,” “believes,” “will,” “achieve,” “anticipate,” “would,” “should,” “subject to” or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.  Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato
646-599-6222

Todd Falls
1-800-391-6755 Extension 222
investor@generex.com

The Top-line Report has been sent to the regulatory authorities in Mexico, and will be provided to U.K. MHRA, and E.U. EMA, with requests for emergency use approval

CytoDyn is preparing a Phase 3 protocol for leronlimab use in long-hauler COVID-19 individuals

VANCOUVER, Washington, Aug. 17, 2020 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company announced today it has provided its Top-line Report from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms to the U.S. Food and Drug Administration (FDA), and requested emergency use approval.

In addition, CytoDyn has sent its Top-line Report of the Phase 2, mild-to-moderate COVID-19 population, to the regulatory authorities in Mexico and hopes to obtain emergency use approval from the MHRA in the U.K., EMA in the European Union, as well as the regulatory authorities in the Philippines.

Along with the above activities, CytoDyn has been approached by several doctors about a clinical study of leronlimab in long-hauler COVID-19 individuals. The Company is preparing a Phase 3 protocol and will file it as soon as possible.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very motivated to provide leronlimab to patients throughout the world who are suffering from COVID-19.  We believe the statistically significant data of NEWS2 findings, along with impressive safety results (less SAEs or AEs with leronlimab vs. placebo), from our Phase 2 trial set forth in the Top-line Report provides compelling data in support of leronlimab’s use to fight COVID-19. We are in discussions with several regulatory agencies in other countries and hope to obtain emergency approval for its use. We are in a very exciting period for CytoDyn in regards to the potential role of leronlimab in three different COVID-19 populations, mild-to-moderate, severe-to-critical, and long-haulers.”

About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. Enrollment continues in its Phase 3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 is believed to typically transmit person-to-person through respiratory droplets. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.

The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab for the prevention of GvHD.

About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The Company has requested a Type A meeting with the FDA to discuss the FDA’s request for additional information in order to resubmit its Biologics License Application for this HIV combination therapy.

CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.

Forward-Looking Statements
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict.  Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTS
Investors:
Michael Mulholland
Office: 360.980.8524, ext. 102
Mobile: 503.341-3514
mmulholland@cytodyn.com

VANCOUVER, British Columbia, Aug. 13, 2020 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, is pleased to announce that it has enrolled its first patient from the U.S. for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19.

The Company is also pleased to announce that it has now enrolled 26 patients since the study began on August 5, 2020. The Phase 2b/3 study enrollment target is 150 patients, aggregated from all participating sites.

“We are very pleased to announce our first U.S. patient,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals. “We have also had steady enrollment from one of our International sites and as a result, we expect to reach 25% of our total target shortly.”

Phase 2b/3 Study Protocol Summary

The Company’s multinational Phase 2b/3 human trial for COVID-19 is entitled, “A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patients with Confirmed COVID-19 Disease.”

The trial will begin as a Phase 2b study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will move directly into a Phase 3 trial. The data from the Phase 2b study will determine the number of patients needed to reach statistical significance in the Phase 3 trial.

Patients will be randomized in a one-to-one manner and will either be treated using an existing standard of care, or standard of care plus Ifenprodil 60 mg (taken as one 20 mg tablet three-times daily) for one arm or standard of care plus Ifenprodil 120 mg (taken as two 20 mg tablets three-times daily) for two weeks.

Over the testing period, doctors will observe whether there is an improvement in a number of secondary endpoints, including mortality, blood oxygen levels, time spent in intensive care and time to mechanical ventilation.

Phase 2b Study Completion and Data Readout

The Company will provide an update to the market shortly on a projected completion date as well as when the read out of the data can be expected.

About NP-120 (Ifenprodil)

NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.

The Company believes Ifenprodil can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in COVID-19 infected patients.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

Algernon has filed new intellectual property rights globally for NP-120 (Ifenprodil) for the treatment of respiratory diseases and is working to develop a proprietary injectable and slow release formulation.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.

The CSE does not accept responsibility for the adequacy or accuracy of this release.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. The Canadian Securities Exchange has not in any way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

• Study approval by Brazil’s ministry of health follows IND approval granted by the FDA in the US
• Brazil represents an important component of Humanigen’s global development program for lenzilumab

VANCOUVER, British Columbia, Aug. 05, 2020 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, is pleased to announce that it has enrolled its first patient in its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19. The countries participating in the study include the U.S., Australia, Romania and the Philippines.

“On March 6^th, 2020 the company announced it had decided to explore Ifenprodil as a possible treatment for COVID-19 and 5 months later we have now begun a Phase 2b/3 human trial,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals. “We look forward to a speedy enrollment of the balance of the patients and we remain hopeful in Ifenprodil’s potential as a therapeutic that will reduce both the severity and duration of a COVID-19 infection.”

Background

The Company announced on March 06, 2020 that it was going to explore Ifenprodil as a possible treatment for COVID-19 when it discovered an independent research study that showed the drug was active in an animal model for H5N1, the world’s most lethal avian flu, with an approximately 60% mortality rate in humans. In the study, Ifenprodil reduced mortality by 40% and reduced acute lung injury and inflammation in the lung tissue.

On July 21, 2020 the Company highlighted a study undertaken by UT Dallas that identified a dramatic upregulation of NMDA receptors in immune cells in the lungs of COVID-19 patients. The study went on to identify possible drug candidates, including Ifenprodil, that could interfere with the receptor’s glutamate signalling pathway and as a result possibly reduce the severity and duration of a COVID infection. Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB) preventing glutamate signalling.

Coupled with the Company’s own animal data showing Ifenprodil’s reduction of lung fibrosis in two separate studies, and its efficacy in an animal model for acute cough, the Company is investigating Ifenprodil to determine if it can reduce the severity and duration of a COVID infection.

Phase 2b/3 Study Protocol Summary

The Company’s multinational Phase 2b/3 human trial for COVID-19 is entitled, “A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patients with Confirmed COVID-19 Disease.”

The trial will begin as a Phase 2b study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will move directly into a Phase 3 trial. The data will determine the number of expected patients needed to reach statistical significance in the Phase 3 trial.

Patients will be randomized in a one-to-one manner and will either be treated using an existing standard of care, or standard of care plus Ifenprodil 60 mg (taken as one 20 mg tablet three-times daily) for one arm or standard of care plus Ifenprodil 120 mg (taken as two 20 mg tablets three-times daily) for two weeks.

Over the testing period, doctors will observe whether there is an improvement in a number of secondary endpoints, including mortality, blood oxygen levels, time spent in intensive care and time to mechanical ventilation.

Phase 2b Study Completion and Data Readout

Now that the study has begun, the Company will make an assessment of the enrollment rate and will provide an update to the market in due course on a projected completion date as well as when the read out of the data can be expected.

About NP-120 (Ifenprodil)

NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.

The Company believes NP-120 can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in COVID-19 infected patients.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

Algernon has filed new intellectual property rights globally for NP-120 (Ifenprodil) for the treatment of respiratory diseases and is working to develop a proprietary injectable and slow release formulation.

The Compay is not making any express or implied claims that NP-120 (Ifenprodil) is an effective treatment for COVID-19.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.

The CSE does not accept responsibility for the adequacy or accuracy of this release.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. The Canadian Securities Exchange has not in any way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

CALGARY, Alberta, Aug. 04, 2020 (GLOBE NEWSWIRE) — XORTX Therapeutics Inc. (“XORTX” or the “Company”) (CSE: XRX) (OTCQB: XRTXF), a biopharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce a partnership with the Icahn School of Medicine at Mount Sinai, New York to study the incidence of Acute Kidney Injury and Hyperuricemia in patients hospitalized with COVID-19.

This clinical study in nearly 4,000 patients with COVID-19 builds upon unpublished observations from over 1,100 individuals, where greater than 60% of individuals with acute kidney injury had elevated uric acid levels above the normal range.  This partnership with Dr. Coca and the Icahn School of Medicine at Mount Sinai in New York is an investigator-led study focused on evaluation of more than 5,600 individuals with COVID-19 infection.

Dr. Steven Coca, lead investigator and Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai stated: “We have witnessed a hypercatabolic phenotype in a significant proportion of patients with AKI, manifested by extremely high serum uric acid levels, along with hyperkalemia and hyperphosphatemia, without overt evidence of rhabdomyolysis. A better understanding of the pathophysiologic causes of COVID-associated AKI is needed, including the potential effect of hyperuricemia on the severity of kidney injury and contribution to poor outcomes. We are pleased to partner with XORTX and perform these analyses to inform future clinical trials for this syndrome.”

Dr. Allen Davidoff, CEO commented: “We are pleased to be advancing this investigator-led clinical study with Drs. Steven Coca and Jaime Uribarri and several other clinicians and investigators at the Icahn School of Medicine at Mount Sinai. This group is arguably the leading medical network in the world and the ability to expand on observations that hospitalized individuals with COVID-19 have very high uric acid level will provide clarity on the association of xanthine oxidase and uric acid acute kidney injury and multi-organ injury with infection. The data collected will be critical for further therapeutic development.”

This news release contains forward-looking information relating to, among other things, statements with respect to the potential for XRx-101 as a treatment to suppress the severity of the coronavirus / COVID-19 infection. Although the Company believes that any such intentions, plans, estimates, beliefs and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs and expectations will prove to be accurate.

Risk Factors for COVID-19

The US Center for Disease Control (CDC) has stated that “people of any age with certain underlying medical conditions are at increased risk for severe illness from COVID-19”. The most susceptible on this list are individuals with chronic kidney disease, chronic obstructive pulmonary disease (COPD), obesity, serious heart conditions, sickle cell disease and diabetes mellitus.¹ Common amongst these groups is a high incidence of endothelial dysfunction, suggesting limited capacity of the endothelium to face physiologic challenges such as viral infection. Evolving evidence suggests that COVID-19 involves direct infection of the endothelial lining of the cardiovascular system.²  In support of this evidence, recent reports suggest that COVID-19 coronavirus attaches to the ACE2 receptor on the endothelial cell layer on blood vessels and that endothelial infection and inflammation – endotheliitis ensues thereafter. Although it is well documented that COVID-19 is primarily manifested as a respiratory tract infection, emerging data indicates that it should be regarded as a systemic disease involving multiple systems including cardiovascular, respiratory, gastrointestinal, neurological, hematopoietic and immune system.

Endothelial dysfunction is a principal determinant of microvascular dysfunction by shifting the vascular equilibrium towards more vasoconstriction with subsequent organ ischaemia, inflammation with associated tissue oedema, and a procoagulant state.³

Hyperuricemia (high uric acid levels) has been linked to cardiovascular and renal diseases, possibly through the generation of reactive oxygen species (ROS) and subsequent endothelial dysfunction.  Hyperuricemia is also closely associated with depletion of endothelial cell nitric oxide availability. The enzymatic effect of xanthine oxidase is the production of ROS and uric acid. Studies have shown that inhibiting xanthine oxidase with allopurinol can reverse endothelial dysfunction. Furthermore, rat studies have shown that hyperuricemia-induced hypertension and vascular disease is at least partially reversed by the supplementation of the nitric oxide synthase (NOS) substrate, L-arginine.⁴

XORTX Therapeutics XRx-101 is a proprietary combination of xanthine oxidase inhibitor oxypurinol and L-Arginine.

About COVID-19 and Acute Kidney Injury

Acute kidney injury (AKI) has been identified as an independent risk factor for patients’ in-hospital mortality due to COVID-19¹. Though early reports suggested a low incidence (between 3% to 9%) of AKI in those with COVID-19^5,6,7, data from the United States indicate that 25-35% of patients hospitalized with COVID-19 develop AKI.^9-11 Up to 20% of those need renal replacement therapy (RRT), and the mortality rate in patients that experience AKI in the setting of COVID-19 is several-fold higher than patients without AKI.¹⁰ Moreover, proteinuria (69-85%) and hematuria (50-65%) are common in COVID-19.^9-11 In previous peer reviewed studies, viral infections such as influenza, when severe, can produce a tumor lysis “like” syndrome, resulting in increased pulmonary, endothelial cell debris and serum uric acid (SUA) levels in the circulation as well as increased cytokine expression. Coronavirus infection appears to follow this pattern.

XORTX Therapeutics has developed XRx-101 (active ingredient Oxypurinol) a xanthine oxidase inhibitor for the treatment of COVID-19 induced AKI. Two key studies (one in a mouse model of influenza and another in herpes infection) have shown that XRx-101’s active ingredient, Oxypurinol, can act as (1) an anti-viral, (2) uric acid lowering treatment, and (3) organ-protective therapy. Specifically, in the setting of serious viral infection and tissue damage, XRx-101 can act to inhibit xanthine oxidase expression due to hypoxia, or tissue destruction, thereby preventing increased serum uric acid (SUA) concentration from reaching saturation levels at which uric acid crystals could trigger acute organ injury. Additionally, excipients in the formulation such as L-arginine, a basic amino acid and nitric oxide source, can increase the aqueous solubility of uric acid, thereby also decreasing uric acid crystal formation associated with tumor lysis-like syndrome due to COVID-19 infection. L-arginine is also reported to protect against kidney injury, in the setting of ischemia reperfusion injury. In concept, XRx-101 may ameliorate the severity of COVID-19 infection comorbidity, mortality, and damage to kidneys. This, in turn, could increase COVID-19 survival rates, especially in vulnerable populations such as the elderly and those with underlying medical conditions, while also lessening dependence on medical infrastructure and medical services.

References:

1. Source: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html
2. Varga Z, et al, Endothelial cell infection and endotheliitis in COVID-19, The Lancet, Vol 395, May 2 2020.
3. Bonetti PO, Lerman LO, Lerman A. Endothelial dysfunction – a marker of atherosclerotic risk. Arterioscl Throm Vas 2003; 23: 168–75.
4. Khosla U.M. et al, Hyperuricemia induces endothelial dysfunction, Kidney International, V67, Issue 5, 1739-1742, 2005
5. Cheng, Y., Luo, R., Wang, K., Zhang, M., Wang, Z., Dong, L., Li, J., Yao, Y., Ge, S. & Xu, G. Kidney impairment is associated with in-hospital death of COVID-19 patients. medRxiv 2020.02.18.20023242
6. Wang, D., Hu, B., Hu, C., Zhu, F., Liu, X., Zhang, J., Wang, B., Xiang, H., Cheng, Z., Xiong, Y., Zhao, Y., Li, Y., Wang, X. & Peng, Z. Clinical Characteristics of 138 Hospitalized Patients with 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA – J. Am. Med. Assoc. 323, 1061–1069 (2020).
7. Guan, W., Ni, Z., Hu, Y., Liang, W., Ou, C., He, J., Liu, L., Shan, H., Lei, C., Hui, D. S., Du, B., Li, L., Zeng, G., Yuen, K.-Y., Chen, R., Tang, C., Wang, T., Chen, P., Xiang, J., et al. Clinical characteristics of 2019 novel coronavirus infection in China. N. Engl. J. Med. 2
8. Volunteers, A.-2019-nCoV, Li, Z., Wu, M., Guo, J., Yao, J., Liao, X., Song, S., Han, M., Li, J., Duan, G., Zhou, Y., Wu, X., Zhou, Z., Wang, T., Hu, M., Chen, X., Fu, Y., Lei, C., Dong, H., et al. Caution on Kidney Dysfunctions of 2019-nCoV Patients.
9. Hirsch JS, Ng JH, Ross DW, et al. Acute Kidney Injury in Patients Hospitalized with Covid-19. Kidney Int. 2020.
10. Chan L, Chaudhary K, Saha A, et al. Acute Kidney Injury in Hospitalized Patients with COVID-19. medRxiv. 2020:2020.2005.2004.20090944.
11. Mohamed MM, Lukitsch I, Torres-Ortiz AE, et al. Acute Kidney Injury Associated with Coronavirus Disease 2019 in Urban New Orleans. Kidney360. 2020:10.34067/KID.0002652020.

About XORTX Therapeutics Inc.

XORTX Therapeutics Inc. is a biopharmaceutical company with three clinically advanced products in development – XRx-008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD), XRx-101 for Coronavirus / COVID-19 infection and XRx-221 is a clinical stage program for Type 2 Diabetic Nephropathy (T2DN). The Company has strong intellectual property rights and established proof of concept through independent clinical studies. XORTX is working to advance its clinical development stage products that target xanthine oxidase to inhibit production of uric acid. At XORTX Therapeutics, we are dedicated to developing medications to improve the quality of life and future of patients.  Additional information on XORTX Therapeutics is available at www.xortx.com.

The CSE has neither approved nor disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

This news release includes forward looking statements that are subject to assumptions, risks and uncertainties. Statements in this news release which are not purely historical are forward looking statements, including without limitation any statements concerning the Company’s intentions, plans, estimates, beliefs or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs and expectations will prove to be accurate. The Company cautions readers that all forward looking statements, including without limitation those relating to the Company’s future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward looking statements. Readers are advised to rely on their own evaluation of such risks and uncertainties and should not place undue reliance on forward looking statements. Any forward looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward looking statements, or to update the reasons why actual events or results could or do differ from those projected in the forward looking statements. The Company assumes no obligations to update any forward looking statements, whether as a result of new information, future events or otherwise.

VANCOUVER, BC, Aug. 4, 2020 /PRNewswire/ – PreveCeutical Medical Inc. (the “Company” or “PreveCeutical”) (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H), is pleased to announce that it is preparing for clinical trials for its Sol-Gel COVID-19 program. (News Release dated May 4, 2020).

PreveCeutical believes that the cannabinoid Sol-gel may reduce the possibility of contracting coronavirus infections.  To ensure that the COVID-19 Sol-Gel clinical program continues to rapidly progress the Company has retained Veristat, a global clinical research organization (CRO) located in Massachusetts, USA, with operations around the world, including Canada, to assist with planning the clinical trial process and writing the required protocols.

Stephen Van Deventer, PreveCeutical’s Chief Executive Officer, commented, “Since the beginning of the pandemic, PreveCeutical has mobilized its scientific understanding to investigate the development of treatments that could potentially reduce the transmission of COVID-19.    We are very pleased with the progress of our COVID-19 Sol-Gel program and are committed to rapidly developing the clinical trial process. To support our efforts, we selected Veristat because of its extensive infectious disease experience and the substantial number of COVID-19 related clinical trials.”    

PreveCeutical is looking for an expedited pathway such as fast-track or Coronavirus treatment acceleration program (CTAP).

Commercial Terms of Agreement

Under the terms of the consulting agreement, Veristat will provide services to design and develop PreveCeutical COVID-19 Sol-Gel clinical program and write the required protocol.

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.

About PreveCeutical

PreveCeutical is a health sciences company that develops innovative options for preventive and curative therapies utilizing organic and nature identical products.

PreveCeutical aims to be a leader in preventive health sciences.  The Company’s current research and development programs include dual gene curative and preventive therapies for diabetes and obesity; the Cannabidiols Sol-Gel Program aiming to provide relief across a range of indications from pain, inflammation, seizures, and neurological disorders; Nature Identical peptides for the treatment of various ailments; non-addictive analgesic peptides as a replacement to the highly addictive analgesics such as morphine, fentanyl and oxycodone; and a therapeutic product for treating athletes who suffer from concussions (mild traumatic brain injury).

For more information about PreveCeutical, please visit our website www.PreveCeutical.com or follow us on Twitter and Facebook.

On behalf of the Board of Directors of PreveCeutical                              

Stephen Van Deventer, Chairman and Chief Executive Officer

Forward-Looking Statements:

This news release contains forward-looking statements and forward-looking information (collectively, “forward-looking statements”) within the meaning of applicable Canadian and U.S. securities legislation, including the United States Private Securities Litigation Reform Act of 1995. All statements in this news release that are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations and orientations regarding the future including, without limitation, the completion of the Program Extension and the successful development of CBD sol-gel formulations which have the ability to reduce the possibility of coronavirus infections, including COVID-19, the anticipated timing of the development of a vaccine for COVID-19, and the continued research interests of PreveCeutical, PreveCeutical’s anticipated business plans, and its prospects of success in executing its proposed plans. Often, but not always, forward-looking statements can be identified by words such as “will”, “pro forma”, “plans”, “expects”, “may”, “should”, “budget”, “schedules”, “estimates”, “forecasts”, “intends”, “anticipates”, “believes”, “potential”, “proposes” or variations of such words including negative variations thereof and phrases that refer to certain actions, events or results that may, could, would, might or will occur or be taken or achieved. Forward-looking statements are based on certain assumptions regarding PreveCeutical, including expected growth, results of operations, including PreveCeutical’s research and development activities, performance, industry trends, growth opportunities, anticipated time periods for the development of a vaccine for COVID-19, that PreveCeutical will be granted requisite expedited approvals by world health agencies for the results of the Program Extension, and that PreveCeutical will be able to obtain the financing required to carry out the Program Extension, retain and attract qualified research personnel and obtain and/or maintain the necessary intellectual property rights needed to carry out future business activities.

Actual results could differ from those projected in any forward-looking statements due to numerous factors including, risks and uncertainties relating to: complexities and delays in connection with research and development activities and the actual results of research and development activities including the successful development of CBD sol-gel formulations which have the ability to reduce the possibility of infections from coronaviruses, including COVID-19; the ability of PreveCeutical to, among other things, protect its respective intellectual property, obtain any required governmental, regulatory or stock exchange approvals, permits, consents or authorizations required, including Canadian Securities Exchange acceptance of any planned future activities and obtaining expedited requisite approvals from world health agencies; and the ability of PreveCeutical to commercialize products, pursue business partnerships, complete their research programs as planned, including the Program Extension, and obtain the financing required to carry out their planned future activities. Other factors such as general economic, market or business conditions or changes in laws, regulations and policies affecting the biotechnology or pharmaceutical industry may also adversely affect the future results or performance of PreveCeutical. These forward-looking statements are made as of the date of this news release and, unless required by applicable law, PreveCeutical assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in these forward-looking statements. Although PreveCeutical believes that the statements, beliefs, plans, expectations, and intentions contained in this news release are reasonable, there can be no assurance that those statements, beliefs, plans, expectations, or intentions will prove to be accurate.  Readers should consider all of the information set forth herein and should also refer to other periodic reports provided by PreveCeutical from time-to-time. These reports and PreveCeutical’s filings are available at www.sedar.com. Neither the Canadian Securities Exchange (CSE or CNSX Markets), its Regulation Services Provider (as that term is defined in policies of the CSE), nor any other regulatory authority accepts responsibility for the adequacy or accuracy of this release.

Readers are cautioned that forward-looking statements are not guarantees of future performance or events and, accordingly, are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty of such statements.

SOURCE PreveCeutical Medical Inc

MIRAMAR, Fla., July 27, 2020 (GLOBE NEWSWIRE) — Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the FDA has accepted their pre-IND briefing package for the Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine, and will provide a written response by August 24, 2020. Due to the significant number of submissions relating to COVID-19, the FDA is only providing written responses rather than conducting face-to-face or teleconferences for Pre-IND meetings.

The Ii-Key-SARS-CoV-2 is designed as a “Complete Vaccine” that has the potential to induce the T-Cell and antibody immune responses that can provide protective immunity with long-lasting immunologic memory against SARS-CoV-2 in a highly specific manner to ensure safety. With their response, the FDA will comment on the Phase I/II clinical trial plan and will provide guidance on the overall development program for the Ii-Key-SARS-CoV-2 vaccine.

Generex CEO, Joseph Moscato, said, “We are pleased that the FDA has accepted our Pre-IND package and have committed the time and resources to review our Ii-Key-SARS-CoV-2 clinical trial plan. Our “Complete Vaccine” has the potential to provide an immediate antibody response and also a long-lasting neutralizing antibody response together with a CD4+ Th1 T-cell response to ensure immune system memory and long-term immunity from COVID-19. It is important to understand that for the last two decades, we have focused on the activation of the cellular CD4+ and CD8+ immune response that is essential for generating long-term memory immunity. While other vaccines target activation of the antibody response and hope to activate a cellular response, the Ii-Key technology directly charges the CD4+ T-cell response against target epitopes, and with the addition of B-cell epitopes in our Ii-Key screening program, we are developing a vaccine that activates neutralizing antibodies while eliminating those peptides that may cause antibody dependent disease enhancement (ADE) or cytokine storm, thereby providing a complete and safe immune response against SARS-CoV-2. We look forward to hearing back from the FDA about our proposed comprehensive development plan and will work with the Agency to define a clear path to commercialization for our Ii-Key-SARS-CoV-2 vaccine. We will keep our investors informed as the program progresses.”

About Generex Biotechnology Corp.
Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

About NuGenerex Immuno-Oncology
NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines for cancer and infectious disease based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) has been spun out of Generex as a separate public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors for the treatment of cancer. NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Merck’s Keytruda^®) for the treatment of triple negative breast cancer. The company has also turned its Ii-Key technology on infectious disease, responding to the coronavirus pandemic with a SARS-CoV-2 vaccine development program.

Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as “expects,” “plan,” “believes,” “will,” “achieve,” “anticipate,” “would,” “should,” “subject to” or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:
Generex Biotechnology Corporation
Joseph Moscato
646-599-6222

Todd Falls
1-800-391-6755 Extension 222
investor@generex.com

Company to Receive Production Sample Kits from its Contract Manufacturer for U.S. FDA Level Testing of Each Modality, Plus Additional Sample GenViro! Swift Kits for International Testing Needs

LOS ANGELES, CA / ACCESSWIRE / July 23, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc., today announced it is immediately readying testing samples of its GenViro! Covid-19 Swift Kits for testing in the US market and additional testing internationally. One-half will be used in a blood-based testing protocol and the other half in a saliva-based testing protocol. Based on the results, the company will make a direct run for completion of the feasibility testing so that sales of GenViro! Swift kits can commence as soon as possible in select International markets in which the company has or shortly expects to have distribution agreements. The company is conducting a parallel “sister” study in Korea, and additional saliva testing will be completed for international distribution.

DECN expects to receive the U.S. supply of production testing samples during the first week of August 2020 which is expected to coincide with the company’s selection of an experienced US based clinical testing partner. The company has narrowed potential US testing partners to two clinical trials organizations and allied laboratories and expects to announce its decision in the next few days. That organization will lead the clinical trials in the U.S. that DECN expects will be the final requirement to secure FDA emergency authorization.

The company plans a total of four studies, two covering feasibility for both the blood based and saliva based modalities, using as a foundation the most recent FDA guidelines for both blood and saliva-based testing, and two each covering the actual clinical testing. Once the feasibility testing is completed, the company will make any final adjustments that may be required to impedance wavelength. And through its European distributor(s) the company will be seeking European CE Mark certification. The CE registration is primarily a Good Manufacturing Practices (GMP) review, which is not as protracted as the FDA testing. Further, to register GenViro! Swift for CE Mark, DECN’s feasibility testing will similarly meet the product registration needs of the recently announced Asian distributor. The company has also had involved discussions with a California organization with worldwide reach. This organization is already an approved FDA establishment provider, and has expressed significant interest in a distribution relationship in the EU, Pakistan and select Middle Eastern countries.

Important to the continued movement toward FDA testing, the company is in the final stages of producing two Point-of-Care instructional videos that will be available on the web site of the company’s subsidiary, Pharma Tech Solutions. These videos are also a part of the FDA EUA (emergency) application process. DECN will furnish subtitles for the videos and will initially be made available in French, German, Spanish and Portuguese. Later versions are contemplated in additional languages.

“Although we have just passed the 120 day mark in the journey to get to this point, we are confident we are ready to conduct the revised FDA level testing required to gain emergency authorization approval here in the US,” said Keith Berman, DECN CEO. “While we have dealt with four separate FDA foundation adjustments since we first began development of our GenViro! Covid-19 Swift Kit products, late last week we learned we aren’t the only small company with proprietary technology that is dealing with such issues. ”

The company has ordered approximately 600 Genviro! Swift testing strips delivered in vials for the feasibility rounds of testing; 300 for testing in both Korea and the U.S. After this initial testing, another 600 test strips for the second, more demanding study to be conducted by the clinical testing partner in the US. Delivery of the second round of test strips is expected the 3^rd week in August. In all, a total of 1,200 testing sensors plus 90 complete GenViro! Test kits will be delivered, 30 available for blood and 30 available for saliva, and another 30 saliva kits available for demonstration and photographic purposes overseas. The company will be updating its Pharma Tech Solutions web site to demonstrate in more detail the contents of the GenViro! Swift test kits.

Mr. Berman concluded, “Finally, it is important that we recognize that the new FDA testing mandates places a huge strain on company resources. Testing is expensive enough, but the testing of infected subjects requires special insurance policies where the premiums are extreme. A bill to be shortly presented in the U.S. Senate seeks to lower liability limits for companies and first responders, and if passed will be among the biggest adjuncts to our expected success.”

ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics Corp. has been the leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters for 18 years. DECN’s products are designed to operate efficiently and less expensively on certain glucose meters already in use by almost 7.5 million diabetics worldwide. The company’s GenViro! products are designed to test for Covid-19, and applications for Emergency (EUA) Waivers have been submitted to the U.S. FDA. The finger stick test kit is currently being readied for international sales and an agreement for distribution has been signed for sales to commence in multiple countries including India, Malaysia, Singapore, Nepal, Bangladesh, Sri Lanka, Indonesia, Thailand, Vietnam and Australia. Registration in those countries where such documentation is required is the responsibility of the distributor.

Forward-Looking Statements:
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of July 22, 2020, regarding the company’s business and performance, its prospects, current factors, the economy, and other future conditions and forecasts of future events, circumstances, and results.

CONTACT INFORMATION:
Decision Diagnostics Corp.
Keith Berman
(805) 446-2973
info@decisiondiagnostics.co
www.genultimate.com
www.genultimatetbg.com
www.pharmatechdirect.com

SOURCE: Decision Diagnostics Corp.

MIRAMAR, Fla., July 27, 2020 (GLOBE NEWSWIRE) — Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the FDA has accepted their pre-IND briefing package for the Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine, and will provide a written response by August 24, 2020. Due to the significant number of submissions relating to COVID-19, the FDA is only providing written responses rather than conducting face-to-face or teleconferences for Pre-IND meetings.

The Ii-Key-SARS-CoV-2 is designed as a “Complete Vaccine” that has the potential to induce the T-Cell and antibody immune responses that can provide protective immunity with long-lasting immunologic memory against SARS-CoV-2 in a highly specific manner to ensure safety. With their response, the FDA will comment on the Phase I/II clinical trial plan and will provide guidance on the overall development program for the Ii-Key-SARS-CoV-2 vaccine.

Generex CEO, Joseph Moscato, said, “We are pleased that the FDA has accepted our Pre-IND package and have committed the time and resources to review our Ii-Key-SARS-CoV-2 clinical trial plan. Our “Complete Vaccine” has the potential to provide an immediate antibody response and also a long-lasting neutralizing antibody response together with a CD4+ Th1 T-cell response to ensure immune system memory and long-term immunity from COVID-19. It is important to understand that for the last two decades, we have focused on the activation of the cellular CD4+ and CD8+ immune response that is essential for generating long-term memory immunity. While other vaccines target activation of the antibody response and hope to activate a cellular response, the Ii-Key technology directly charges the CD4+ T-cell response against target epitopes, and with the addition of B-cell epitopes in our Ii-Key screening program, we are developing a vaccine that activates neutralizing antibodies while eliminating those peptides that may cause antibody dependent disease enhancement (ADE) or cytokine storm, thereby providing a complete and safe immune response against SARS-CoV-2. We look forward to hearing back from the FDA about our proposed comprehensive development plan and will work with the Agency to define a clear path to commercialization for our Ii-Key-SARS-CoV-2 vaccine. We will keep our investors informed as the program progresses.”

About Generex Biotechnology Corp.
Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

About NuGenerex Immuno-Oncology
NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines for cancer and infectious disease based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) has been spun out of Generex as a separate public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors for the treatment of cancer. NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Merck’s Keytruda^®) for the treatment of triple negative breast cancer. The company has also turned its Ii-Key technology on infectious disease, responding to the coronavirus pandemic with a SARS-CoV-2 vaccine development program.

Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as “expects,” “plan,” “believes,” “will,” “achieve,” “anticipate,” “would,” “should,” “subject to” or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:
Generex Biotechnology Corporation
Joseph Moscato
646-599-6222

Todd Falls
1-800-391-6755 Extension 222
investor@generex.com

FLORHAM PARK, N.J., July 27, 2020 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced preclinical data for its COVID-19 vaccine candidate, Versamune-CoV-2 (PDS0203). PDS0203 pairs the Versamune® platform with a recombinant protein recognized by the human immune system that is derived from the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus that causes COVID-19. The protein included in PDS0203 encompasses SARS-CoV-2 sections that induce an antibody response, as well as sections that are recognized by CD8 and CD4 T-cells.

PDS Biotech has generated robust preclinical data confirming that PDS0203 elicits induction of highly active and potent virus-specific CD8 killer and CD4 helper T-cells within 14 days of treatment. Importantly, the study also demonstrated induction of the long-lasting virus-specific memory T-cells necessary for longer term protection. PDS0203 demonstrated a 30-45 fold increase in COVID-19 specific T-cells by Day 14 when compared to the vaccine without Versamune®. These preclinical studies also confirmed induction of strong anti-SARS-CoV-2 neutralizing antibodies within 14 days, with a 20-25-fold increase when compared to the vaccine without Versamune®. Lastly, these preclinical studies showed a further substantial increase in neutralizing antibody levels continuing more than 30 days after vaccination. PDS Biotech plans to submit details of the preclinical studies to a peer reviewed scientific journal.

“Recent COVID-19 research has highlighted the critical importance of developing vaccines capable of generating high levels of targeted CD8 and CD4 T-cells, in addition to neutralizing antibodies, to achieve durable protection against COVID-19 infection. Our preclinical data shows PDS0203’s ability to rapidly induce both protective antibodies and long-lasting T-cells specific for COVID-19,” commented Dr. Frank Bedu-Addo, CEO of PDS Biotech, “Due to the mechanism by which Versamune® activates a disease-specific immune response, our PDS0101 program demonstrated successful translation of T-cell induction and safety data from preclinical models to humans. We therefore believe that this encouraging PDS0203 preclinical data may similarly translate to humans. If so, then it may present unique potential to provide the breadth and level of immune responses necessary for a safe and effective vaccine with long-term protection against COVID-19.”

As previously announced, the Company has also initiated preclinical development of Versamune®-CoV-2FC (PDS0204), a COVID-19 vaccine candidate being developed in partnership with Brazil-based Farmacore Biotechnology, which combines the immune-activating Versamune® platform with a Farmacore-developed SARS-CoV-2 recombinant fusion protein.

About the Versamune® technology platform

The Versamune® technology is based on proprietary immune activating lipids that uniquely activate an important immunological signaling pathway, called the Type 1 interferon signaling pathway, known to be important in the induction of both anti-viral and anti-tumor immune responses. It also promotes efficient access of the disease-specific immunologically recognized protein (antigen) into two important immunological pathways called the Class I and II MHC pathways, therefore enabling powerful induction and activation if CD8 (Killer) and CD4 (helper) T-cells that can recognize, kill and protect against the specific disease. The technology is protected by multiple international composition and application patents.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0203

PDS0203 is a COVID-19 vaccine candidate that combines the utility of the Versamune® platform with a recombinant native Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein. The World Health Organization (WHO) declared the COVID-19 outbreak caused by a novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), a global health emergency in January of 2020. Within three months of initial discovery COVID-19 was declared a global pandemic, reflecting alarming levels of spread and severity and resulting in unprecedented action by local and national governments to restrict the movement of citizens to contain the spread. Building immunity to the disease is the key to stopping its spread. A COVID-19 vaccine would train the immune system to recognize and destroy the virus without the vaccinated person getting sick.

About PDS0204

PDS0204 is a COVID-19 vaccine candidate that combines the utility of the Versamune® platform with a Farmacore-developed recombinant fusion protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) declared the COVID-19 outbreak caused by a novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), a global health emergency in January of 2020. Within three months of initial discovery COVID-19 was declared a global pandemic, reflecting alarming levels of spread and severity and resulting in unprecedented action by local and national governments to restrict the movement of citizens to contain the spread. Building immunity to the disease is the key to stopping its spread. A COVID-19 vaccine would train the immune system to recognize and destroy the virus without the vaccinated person getting sick.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101; the preclinical results of the Company’s PDS0203 and PDS0204 product candidates, which will be subject to more rigorous testing and which are not necessarily indicative of future clinical results; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and PDS0204, and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the acceptance by the market of the Company’s product candidates, if approved, and the overall performance and success of the Company’s product candidates; the number or type of studies or nature of results necessary to support the filing of a new drug application for any of the Company’s current product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Alexander Lobo
The Ruth Group
Phone: +1 (646) 536-7037
Email: alobo@theruthgroup.com

WAKEFIELD, Mass., July 20, 2020 (GLOBE NEWSWIRE) — Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, reports today receiving new data from ongoing laboratory testing being conducted at a U.S. Regional Biocontainment Laboratory (RBL). The data is helping to inform the planned Phase 2 clinical trial of Brilacidin for COVID-19, targeted to commence in Q4 2020.

Recently released in vitro data showed Brilacidin exhibited a potent inhibitory effect on SARS-CoV-2, the novel coronavirus responsible for COVID-19, in a human lung epithelial cell line—reducing viral load by 95 percent and 97 percent at two efficacious concentrations tested, compared to control (DMSO).

The new data, using the same assay method, reveal Brilacidin exhibited a similarly potent inhibitory effect against SARS-CoV-2 at an even lower concentration in the same human lung epithelial cell line. Brilacidin achieved approximately 90 percent inhibition of SARS-CoV-2 at a drug concentration that was one-half lower than previously tested. The lowest concentration of Brilacidin used in RBL testing to date is well below the clinically-achievable concentration based on the pharmacokinetics observed in the Company’s Phase 2b clinical trial of Brilacidin in Acute Bacterial Skin and Skin Structure Infections.

Additional RBL testing will assess Brilacidin’s inhibition against SARS-CoV-2 in the human lung epithelial cell line at even lower concentrations to allow for accurate determination of Brilacidin IC50 and IC90 values—the drug concentration at which 50 percent and 90 percent of the virus is inhibited. IC90 rather than IC50 values are considered valuable measures of drug potency as they are more likely to reflect in vitro results translating to comparable results in humans.

Brilacidin/Remdesivir

To put the new RBL testing results in additional context, an article published in Nature showed that Gilead Sciences’ Remdesivir achieved 50 percent inhibition against SARS-CoV-2, in a time-of-addition experiment, at a concentration of 3.7 μM in Vero (animal) cells. Remdesivir has received attention worldwide as one of the few effective therapies for treating COVID-19, gaining varying levels of authorized use in the U.S., E.U., U.K., India, Singapore, Japan, and Australia.

In the RBL assay (which included Brilacidin pre-incubated with virus), Brilacidin exhibited approximately 90 percent inhibition against SARS-CoV-2 at a concentration similar to that of Remdesivir, which again reported 50 percent inhibition of the coronavirus. The Brilacidin inhibition assay was tested in a human lung epithelial cell line, with Remdesivir tested in Vero cells. The RBL data also supports Brilacidin showing an ability to inhibit viral entry into cells, a highly desirable mechanism of action as it is the first step in the infection process enabling viruses to be targeted outside the cell, whereas Remdesivir impacts viral replication only after the host cell has been infected.

The Company believes that Brilacidin and Remdesivir, tested in combination, may generate even greater antiviral potency. RBL staff and the Company are considering conducting in vitro experiments to assess such potential synergistic effects. No assurances are made or implied that such combination studies will be conducted.

More detailed data, based on the ongoing antiviral testing being conducted at the RBL, is planned to be submitted for peer-review publication.

For researchers and institutions interested in collaborating on Brilacidin for COVID-19, please send inquiries to: covid19@ipharminc.com

Brilacidin and COVID-19

Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing an established safety and efficacy database on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Ongoing laboratory testing conducted at a U.S. Regional Biocontainment Laboratory (RBL), and at a Public Health Research Institute (PHRI), supports Brilacidin’s antiviral ability to safely inhibit SARS-CoV-2 in both human and animal cell lines. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Additional pre-clinical and clinical data support Brilacidin’s potential to inhibit IL-6, IL-1β, TNF-α and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. These data collectively support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—anti-COVID-19 therapeutic candidate.

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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious disease, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Brilacidin, based on promising in vitro antiviral activity against SARS-CoV-2, is being evaluated as a potential treatment for COVID-19. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. More information is available on the Company website at www.IPharmInc.com.

Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning the future execution of a definitive agreement with a global pharmaceutical company and the anticipated terms thereof, our future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other coronaviruses; other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks but not limited to risks related to conducting pre-clinical studies and clinical trials and seeking IND regulatory approval for Brilacidin; that prior test results may not be replicated in future studies and trials, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

INVESTOR AND MEDIA CONTACT
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com

• Submitted Pre-IND briefing package outlining proposed clinical development program for Ii-Key-SARS-CoV-2 prophylactic peptide vaccine against the coronavirus pandemic
• Final protocol submitted with package to conduct a Phase I/II human clinical trial

MIRAMAR, Fla., July 20, 2020 (GLOBE NEWSWIRE) — Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the company has submitted a pre-IND briefing package to FDA requesting regulatory guidance on the Phase I/II clinical trial protocol and clinical development plan for the Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine.

The Ii-Key-SARS-CoV-2 peptide epitopes, which contain target amino acid sequences from the virus, will be screened against blood samples collected from COVID-19 convalescent (recovered) patients to select those Ii-Key peptides that activate the immune system to fight the coronavirus infection. The blood screening program, which is scheduled to begin next week, incorporates T Cell Assays, antibody screening and isolation, virus neutralization tests (PRNT – Plaque Reduction Neutralization Test), and a novel in-vitro “cytokine storm” cellular assay. Through this proprietary method, Generex can identify the Ii-Key-SARS-CoV-2 peptides vaccines most likely to stimulate the appropriate T-Cell (CD4 and CD8) responses and modulate the correct immune system responses to minimize potential for dysregulated cytokine-related inflammation, stimulate a neutralizing antibody response, with the goal of providing a broad-spectrum coverage for the vast majority of people. This strategy leverages Ii-Key technology to develop a “Complete Vaccine” that has the potential to induce the likelihood of protective immunity with long-lasting immunologic memory against SARS-COV-2 in a highly specific manner to ensure safety.

Generex CEO, Joseph Moscato said, “Since we filed our application with BARDA for the development of a COVID-19 vaccine eleven weeks ago, we have pushed forward with our Ii-Key-SARS-CoV-2 vaccine development program, making significant strides. We have manufactured the Ii-Key-SARS-CoV-2 peptides that have been selected based on computational analysis of the viral sequence. We have secured blood samples from convalescent COVID-19 patients and isolated the peripheral blood monocytes cells (PBMCs) that will be used by our immunology laboratories for testing of the Ii-Key peptides in our COVID-19 blood screening program. Working with our integrated team of internal and external professionals, we have finalized our protocol, which is comprehensive and highly focused on the safety of human subjects who enroll in our trials. Additionally, the protocol provides for a thorough immunology analysis to determine the exact immunological responses generated by Ii-Key vaccination. With this Pre-IND submission, we have highlighted the potential for our Ii-Key-SARS-CoV-2 to provide a “Complete Vaccine” that not only provides a short-term antibody response, but also a long-lasting neutralizing antibody response and a CD4+ Th1 T-cell response to ensure immune system memory and long-term immunity from COVID-19. We look forward to working with the FDA to define a clear path to commercialization for our Ii-Key-SARS-CoV-2 vaccine and we will keep our investors informed as the development program progresses.”

Mr. Moscato Continued, “As the months and days have passed since the onslaught of this pandemic, we have learned that this novel virus is unlike anything we’ve seen before. The systemic, long-term effects of COVID-19 such as blood clotting, respiratory distress, circulatory problems, and even neurological deficits present major problems for the population in both the short and long term. There is also evidence that the antibody responses in many COVID-19 patients are short-lived, leading to the possibility that patients who have recovered from the disease might be re-infected with the SARS-CoV-2 virus a second time, which could be even more dangerous and lethal the second time around, with more serious long-term effects. Without seroconversion from the short-lived antibody response to a long-term immunity with memory, a COVID-19 patient or a vaccine recipient that doesn’t generate the cellular responses required for memory immunity may be at risk of re-infection. This highlights the major unmet need for our Ii-Key vaccine that is designed as a “Complete Vaccine”, which can generate neutralizing antibodies via the humoral immune response and can activate the CD4+ and CD8+ cellular responses with the goal of offering long-term protection from this pandemic that continues to ravage the world.”

About Generex Biotechnology Corp.
Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

About NuGenerex Immuno-Oncology
NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines for cancer and infectious disease based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) has been spun out of Generex as a separate public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors for the treatment of cancer. NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Merck’s Keytruda®) for the treatment of triple negative breast cancer. The company has also turned its Ii-Key technology on infectious disease, responding to the coronavirus pandemic with a SARS-CoV-2 vaccine development program.

Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as “expects,” “plan,” “believes,” “will,” “achieve,” “anticipate,” “would,” “should,” “subject to” or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.  Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato
646-599-6222

Todd Falls
1-800-391-6755 Extension 222
investor@generex.com

Toronto, Ontario–(Newsfile Corp. – July 16, 2020) – Therma Bright Inc. (TSXV: THRM), (“Therma” or the “Company”), a progressive medical device technology company, is pleased to provide an update on its project with Orpheus Medica to develop a rapid test to detect COVID-19 virus in saliva – the CoviSafeTM.

The project will integrate Orpheus’ novel biologics platform, coupled with third party rapid detection and portable device technology, to develop a reliable palm-sized test for screening of COVID-19 virus in saliva. Orpheus and its academic collaborators have already spent over $500,000 on the development of a series of novel antibody and peptide-based detection molecules, identified through its existing intellectual property, know-how and infrastructure.

The proposed COVID-19 rapid saliva test is intended to have unique features such as high sensitivity, accuracy and specificity while delivering results in less than 20 minutes. Orpheus has substantial experience developing rapid tests, including roadside THC drug screening kits for saliva and other biological samples. The design and development of the fundamental components of the proposed test have already begun, which may allow Therma and Orpheus to deliver a solution to the Canadian and global markets.

The parties’ arrangement is subject to completion of due diligence and successful negotiation of comprehensive terms and conditions of a definitive development project agreement. The parties’ arrangement is subject to acceptance by the TSX Venture Exchange.

Mr. Rob Fia, CEO of Therma Bright commented, “We are pleased with the level of interest in this project by the investor community. As a result, we have posted a new presentation on our website, www.thermabright.com/therma-orpheus/which provides additional information on the project, the market opportunity and preliminary details on the CoviSafeTM product. I am also able to report that we are moving forward with our fundraising efforts and due diligence and expect to finalize the definitive agreements within the 30-day period, as reported on July 7, 2020.

About Therma Bright Inc.

Therma Bright is a progressive medical device technology company focused on providing consumers and medical professionals with quality medical devices that address their medical and healthcare needs. The Company’s initial breakthrough proprietary technology delivers effective, non-invasive and pain-free skincare. Therma Bright received a Class II medical device status from the FDA for its platform technology that is indicated for the relief of the pain, itch, and inflammation of a variety of insect bites or stings. The Company received clearance for the above claims from the US FDA in 1997.

Therma Bright Inc. trades on the TSXV (TSXV: THRM). For more information visit: www.thermabright.com and www.coldsores.com.

About Orpheus Medica Inc.

Orpheus Medica is a privately held Canadian biotech company focused on the development and commercialization of innovative diagnostic and therapeutics for unmet medical needs. Orpheus, with its fully integrated R&D infrastructure, provides strategic partners and collaborators access to its proven and proprietary discovery and development of novel biopharmaceutical products. Our team has over 30 years of combined experience in developing disruptive and cutting-edge technologies based on deployment of an advanced Artificial Intelligence, machine and deep learning processes combined with biological and small molecules platforms leading to optimal drug candidate selection.

For further information, please contact:

Therma Bright
Rob Fia, CEO
rfia@thermabright.com

Orpheus Medica
Saeid Babaei, Chairman & CEO
sbabaei@orpheusmed.com

FORWARD LOOKING STATEMENTS

Certain statements in this news release constitute “forward-looking” statements. These statements relate to future events such as development and commercialization of a rapid COVID-19 viral assay and related instrumentation, manufacturing PPE and hand sanitizers and applying for government grants to support the Company’s future performance, as described in the news release. All such statements involve substantial known and unknown risks, uncertainties and other factors which may cause the actual results to vary from those expressed or implied by such forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether or not such results will be achieved. Actual results could differ materially from those anticipated due to a number of factors and risks. Although the forward-looking statements contained in this news release are based upon what management of the Company believes are reasonable assumptions on the date of this news release, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required under applicable securities regulations.

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 press release.

This press release is not an offer of the securities for sale in the United States. The securities have not been registered under the U.S. Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an exemption from registration. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful.

OTTAWA, CANADA / ACCESSWIRE / July 16, 2020 / Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSXV:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is excited to announce that the U.S. Food and Drug Administration (FDA) has favorably reviewed the company’s Pre-Investigational New Drug (PIND) application for ARDS-003. The review was conducted within the framework of the Coronavirus Treatment Acceleration Program (CTAP), the FDA’s expedited process for investigational therapies to treat COVID-19 patients.

Dr. Guy Chamberland, CEO and CRO commented, “ARDS-003 is an investigational drug designed to dampen the cytokine release syndrome and prevent the development of Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious, life-threatening condition that develops as a result of infection by SARS-COV-2. The Company is not making any expressed or implied claims that its product has the ability to eliminate, cure and/or contain the COVID-19 or the SARS-COV-2 virus at this time.

Tetra is extremely pleased with the positive feedback provided by the FDA for the development of ARDS-003, an innovative novel investigational new drug for COVID-19 patients. Overall, the FDA agreed with Tetra’s proposed active substance and finished product specifications as well as the stability programs. The FDA stated that the nonclinical program was appropriate to support initiating phase 1 study. The FDA confirmed that assessments such as blood compatibility and local irritation, which are typically required for intravenous drug products will be required. These are part of Tetra’s nonclinical program and are currently ongoing. The FDA also stated that no additional nonclinical safety studies would be required to initiate phase 2 studies in SARS-COV-2 patients.

The majority of toxicology studies were not completed at the time of the submission of the PIND meeting package, including how humans may metabolize ARDS-003. The FDA stated that humans may metabolize cannabinoids differently than standard nonclinical toxicology test species such as rodents and canines (e.g. cannabidiol also known as CBD). Therefore, Tetra’s development program needed to identify disproportionate or human specific metabolites and address the safety of human major metabolites. The safety of human major metabolites needs to be emphasized given the concerns that the FDA raised over the nonclinical safety program of Epidiolex (CBD). Tetra is confirming that these toxicology studies have been completed, and we did not identify any disproportionate or human specific metabolite for ARDS-003.

COVID-19 Pandemic impact on global health care

The COVID-19 pandemic is having a major impact on global health care. Hospitals and emergency clinics have been hard hit by this pandemic and some intensive care units (ICUs) have been reaching overcapacity thereby limiting access to optimal care for some severely ill patients. As the pandemic completes its first wave of infection, physicians and scientists have learned a tremendous amount about the consequences of the cytokine release syndrome, often referred to as the cytokine storm. The clinical picture that has evolved from the risk and consequences of acute respiratory distress syndrome (ARDS) requiring oxygen therapy to potential consequences caused by the cytokine release syndrome. These consequences include scarring of the lungs (pulmonary fibrosis) to organ injury caused by the decrease in blood perfusion to the tissue. The medical community is in urgent need of drugs that can reduce the strength and duration of the severe inflammation. It is anticipated that this type of new drug would favorably impact health care and possibly reduce the negative health outcomes post infection.

Dr. Guy Chamberland, CEO and CRO commented, “We received the response from the FDA last week and are excited to share this feedback with our shareholders. The feedback received is extremely positive news because now we have confidence that the rodent and nonrodent species used in the nonclinical toxicology study will provide a relevant assessment of the safety profile of the new drug (ARDS-003) prior to first-in-human trials. The impact of this outcome will result in a decreased cost to run the drug development program because any human-specific metabolite or disproportionate metabolite requires additional toxicology testing and has a significant effect on the overall cost of and time to complete the program. This will allow us to design the program in such a way that we can potentially further increase shareholder value.” The FDA also provided detailed feedback on the proposed Phase 1 and 2 clinical trial protocols. “The FDA repeatedly stated that they want clinical trials for COVID-19 to begin as soon as possible, as long as they meet regulatory requirements. In addition, the FDA stressed the importance that the trials be designed to rapidly address the question of whether a drug has any potential efficacy in COVID-19 patients. Based on this guidance, Tetra will revise its proposed clinical trial protocols to ensure that we expedite the answer to this question for the World Health Organization and the Canadian and USA governments. In addition, Tetra is planning to initiate a study in COVID-19 patients in parallel to conducting the phase 1 trial in healthy volunteers. Tetra expects to start the Phase 1 trial in late September 2020. The treatment phase of the study should be completed within the two months followed by the analysis and reporting phase. Our plan is to obtain preliminary efficacy data from a small well-controlled clinical trial as soon as we can”, stated Dr. Chamberland.

“Many companies have joined the quest for an effective treatment for the cytokine storm. A number of these companies have repurposed drugs, including arthritis-type drugs hoping that these older molecules will be effective. ARDS-003, however, is an innovative molecule that has been studied for more than a decade, specifically as a treatment for sepsis and severe inflammatory reactions. Tetra is not repurposing our drug for the COVID-19 pandemic. Rather, we are accelerating a drug development program of a drug designed to treat this type of serious health condition. This is in-line with Tetra’s goal to develop patent protected innovative therapies for patients with serious health conditions. Tetra’s research team works hard to develop intellectual property to ensure that our products, and their markets, are well protected providing value for our share-holders” said Guy Chamberland, Chief Executive Officer and CRO of Tetra Bio-Pharma.

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX-V:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.

For more information visit: www.tetrabiopharma.com

Source: Tetra Bio-Pharma

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 release.

Forward-looking statements

Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

For further information, please contact Tetra Bio-Pharma Inc.:

Investor Contact:

Tetra Bio-Pharma Inc.
Dr. Guy Chamberland, M.Sc., Ph.D.
Chief Executive Officer
Phone: + 1 (833) 977-7575
investors@tetrabiopharma.com

VANCOUVER, British Columbia, July 16, 2020 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, is pleased to announce that it has completed its clinical trial agreement with Westchester Research Center at Westchester General Hospital in Miami, Florida, for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for COVID-19. The principal investigator is Dr. Aimee Gonzalez, MD. Ifenprodil is an NMDA receptor antagonist specifically targeting the NMDA-type subunit 2B.

The Company is planning to conduct a site initiation visit at Westchester General Hospital during the week of July 20, 2020 and enrolment of patients in the study can begin shortly thereafter.

The Company is in final contractual negotiations with 4 additional U.S. clinical sites. The Company has already received ethics approval from a central institutional review board for all of the U.S. study sites. The Company is also in the final stages of completing contractual negotiations and receiving ethics approval in Australia, Romania and the Philippines.

“Of the 5 U.S. research institutions we have been working with, two are located in Florida where they have recently had a significant number of confirmed COVID-19 cases,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals. “We look forward to working with Dr. Gonzalez and appreciate her work in helping to get the trial started at Westchester General as soon as possible.”

Background

The Company announced on March 06, 2020 that it was going to explore Ifenprodil as a possible treatment for COVID-19 when it discovered an independent research study that showed the drug was active in an animal model for H5N1, the world’s most lethal avian flu, with an approximately 60% mortality rate in humans. In the study, Ifenprodil reduced mortality by 40% and reduced acute lung injury and inflammation in the lung tissue.

Coupled with the Company’s own animal data showing Ifenprodil’s reduction of lung fibrosis in two separate studies, the Company is investigating Ifenprodil to determine if it can reduce the severity and duration of a COVID infection.

Phase 2b/3 Study Protocol Summary

The Company’s multinational Phase 2b/3 human trial for COVID-19 is entitled, “A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patients with Confirmed COVID-19 Disease.”

The trial will begin as a Phase 2b study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will move directly into a Phase 3 trial. The data will determine the number of expected patients needed to reach statistical significance in the Phase 3 trial.

Patients will be randomized in a one-to-one manner and will either be treated using an existing standard of care, or standard of care plus Ifenprodil 60 mg (taken as one 20 mg tablet three-times daily) for one arm or standard of care plus Ifenprodil 120 mg (taken as two 20 mg tablets three-times daily) for two weeks.

Over the testing period, doctors will observe whether there is an improvement in a number of secondary endpoints, including mortality, blood oxygen levels, time spent in intensive care and time to mechanical ventilation.

Trial Start Date

Enrollment of the 1^st patient for the Phase 2b/3 study is expected before the end of July 2020. It is difficult to assess at this time what the enrollment rate for the study will be across all countries and all sites selected. After the study begins, the Company will make an assessment of the enrollment rate and will provide an update to the market on a projected completion date as well as when the data will be expected.

About NP-120 (Ifenprodil)

NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.

The Company believes NP-120 can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in COVID-19 infected patients.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

Algernon has filed new intellectual property rights globally for NP-120 (Ifenprodil) for the treatment of respiratory diseases and is working to develop a proprietary injectable and slow release formulation.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701

info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.

The CSE does not accept responsibility for the adequacy or accuracy of this release.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. The Canadian Securities Exchange has not in any way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

HOUSTON, July 15, 2020 /PRNewswire/ — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that it has entered into an agreement with Sterling Pharma USA LLC for US production of WP1122 to support its expanded development efforts in preparation for submitting a request to the US Food and Drug Administration (“FDA”) for Investigational New Drug (“IND”) status for WP1122 for the potential treatment of COVID-19.

“In light of the added complexity surrounding drug production during the current COVID-19 pandemic, we wanted to make sure we had a reliable source of drug supply located here in the US,” commented Walter Klemp, Chairman and CEO of Moleculin. “We are expanding our planned preclinical studies for the IND, including testing multiple analogs of WP1122 against various viruses in vitro, and potentially, in vivo. The latter will be difficult to time due to the current high demand for in vivo testing for the treatment of COVID-19. Our contract with Sterling Pharma Solutions should help provide us with sufficient product to support this increased use in combination with our expected clinical trials.”

The planned tests are intended to provide additional comparative data of WP1122 and its close analogs. Additionally, the results of in vitro testing thus far led the Company to believe that conventional methods of antiviral testing may not be ideally suited to test the class of agents represented by 2-DG and WP1122 and testing methods may need to be optimized to reflect the full antiviral potential of these sugar antimetabolites. Management believes the mechanism of action of 2-DG and WP1122 is very different from other drugs being developed for COVID-19. Specifically, because 2-DG has been shown to target glucose metabolism and the process of glycosylation, in vitro testing results are significantly affected by the concentration of natural glucose in the microenvironment present during viral replication and continued infection. For this reason, and consistent with guidance from the FDA, the Company will seek to evaluate WP1122 in an animal model for COVID-19 as a part of its IND preparation.

Mr. Klemp concluded: “It’s also worth remembering that an additional benefit of the IND-enabling work we are doing for WP1122 for the possible treatment of patients with COVID-19 is that this also supports the necessary work for an IND for WP1122 for the potential treatment of patients with other viral infections or certain cancers.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity, being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML; WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, being studied for brain tumors, pancreatic cancer and hematologic malignancies; and WP1220, an analog to WP1066, being studied for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition, such as WP1122. Moleculin has the exclusive worldwide rights (subject to certain territories for which it has issued sublicenses) to all of the above technologies.

For more information about the Company, please visit http://www.moleculin.com.

About Sterling Pharma Solutions

Sterling Pharma Solutions is a contract development and manufacturing organisation (CDMO) with world class facilities in both the UK and the US. Sterling has over 50 years’ experience in delivering comprehensive small molecule services spanning pre-clinical development to full commercial cGMP manufacturing.

Widely recognised for its expertise in complex, hazardous chemistry and its service oriented customer experience, Sterling is a proven and trusted partner to the world’s most innovative biotechs and leading pharmaceuticals.

For more information about the company, please visit www.sterlingpharmasolutions.com | Twitter: @sterling_pharma | Linkedin: /sterling-pharma-solutions.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1122 to show sufficient antiviral potential in vitro and in vivo models, the ability of Moleculin to file an IND submission by the end of 2020 and the ability of WP1122 to be shown safe and effective for the treatment of COVID-19, other viral diseases, or cancer. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

SEATTLE, WASHINGTON and VANCOUVER, BRITISH COLUMBIA, July 14, 2020 – Pascal Biosciences Inc. (TSX.V:PAS) (OTC:BIMUF) (“Pascal” or the “Company”) today announced the Company has discovered certain cannabinoids that block replication of SARS-CoV-2, the coronavirus that causes COVID-19. In a cell-based assay, the best cannabinoid had potency similar to remdesivir, a recently approved drug from Gilead that improves recovery time for COVID-19 patients. This suggests a Pascal-identified cannabinoid may have the potential to limit the severity and progression of the disease.

To contribute to research efforts during the coronavirus pandemic, Pascal scientists searched for compounds, including cannabinoids, that have activity against SARS-CoV-2 in a cell-based assay. These results will be further confirmed with additional assays, leading to clinical trials which Pascal hopes to begin within a year. Pascal believes it is the first to identify a cannabinoid that directly inhibits the virus, and the company has applied for patent protection for this unique discovery.

“Because most cannabinoids have a good safety profile and favorable pharmacological properties, we are hopeful that this discovery will provide therapeutic benefit for COVID-19,” commented Dr. Patrick Gray, CEO of Pascal Biosciences. “The incidence of this disease continues to increase, so we look forward to translating our results into clinical studies as soon as possible.”

There are many efforts throughout the world to create a vaccine or therapeutic drug for SARS-CoV-2 infection. Most experts estimate it will take a year or more to produce, test, and manufacture sufficient quantities of an effective vaccine. The path to identifying COVID-19 therapeutics has been faster, leading to emergency authorization of remdesivir in the US and approval in the UK for dexamethasone. Both of these drugs have improved outcomes for hospitalized COVID-19 patients. Typically, multiple drugs are required to provide effective antiviral therapy. For example, other viral diseases such as HIV and Hepatitis C require two or three drugs for effective treatment. Based on the novel Pascal discovery, a cannabinoid may well become an essential component of an effective drug cocktail for the treatment of COVID-19.

About Pascal Biosciences Inc. 

Pascal is a biotechnology company targeting innovative therapies for serious diseases, including COVID-19. Pascal is also developing treatments for cancer with targeted therapies for acute lymphoblastic leukemia and cannabinoid-based therapeutics. Pascal’s leading portfolio also comprises a small molecule therapeutic, PAS-403, that is advancing into clinical trials for the treatment of glioblastoma, and PAS-393, an immuno-stimulatory cannabinoid to be used in combination with checkpoint inhibitor therapy. For more information, visit www.pascalbiosciences.com.

ON BEHALF OF THE BOARD OF DIRECTORS
Dr. Patrick W. Gray, CEO

Investors:
invest@pascalbiosciences.com

Media Contact:
Julie Rathbun
info@pascalbiosciences.com
Tel: 206-769-9219

DISCLAIMER
Certain statements in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments express or implied by such forward-looking statements or information. Such factors include, among others, our stage of development, lack of any product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market our products, the ability to protect our intellectual property, dependence on collaborative partners and the prospects for negotiating additional corporate collaborations or licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties that: products that we develop may not succeed in preclinical or clinical trials, or future products in our targeted corporate objectives; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and the costs of launching our products may be greater than anticipated; we have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in our filings with the Canadian securities regulatory authorities at www.sedar.com. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward- looking statements and information to reflect subsequent events or circumstances, except as required by law.

“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 release”