Category: Biotech News

GERMANTOWN, Md., July 14, 2020 (GLOBE NEWSWIRE) — Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a pioneering global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs), today announces that it has entered into a Collaboration Agreement with Educell Ltd., a premier European cell therapy company. Under the agreement, the parties plan to conduct one or more collaborative cell-based research projects aligned with local medical centers.

The companies will leverage the Orgenesis Cell and Gene Therapy (CGT) Biotech Platform which includes point of care (POCare) Networks, POCare Therapeutics and a POCare Technologies suite of proprietary and in-licensed technologies that have been engineered to create customized processing systems. The agreement is part of the Orgenesis strategy of growing and expanding the POCare Network, which includes leading hospitals and research institutes around the world. The first collaboration under the agreement will focus on the clinical development of CAR-T and whole cell-based vaccine platform for use in cancer immunotherapies.

Vered Caplan, CEO of Orgenesis, stated, “This latest collaboration with Educell expands our activities in Europe and we believe that it should help us launch our therapies into additional European hospitals, as well as help Educell commercialize their therapies around the world. We also believe that this collaboration reinforces the significant value proposition and flexibility of our CGT Biotech Platform. We look forward to benefiting from the expertise of Educell as we seek to expand our automated T-cell culturing approach into clinical validation and commercialization phases.”

Dr Miomir Kneževic, CEO of Educell, commented, “We are excited to team with Orgenesis to potentially advance these breakthrough therapies into clinical trials using cutting edge technologies. This collaboration reflects our commitment to bringing new, effective and affordable cell and gene therapy products to cancer patients worldwide while highlighting Educell’s ability to ensure safety in the process and help to reduce overall manufacturing costs.”

Together, the companies are working to address significant unmet market needs for producing novel cell therapies in a cost effective, high quality and scalable manner. The joint clinical development program seeks to provide safe, simplified, and cost-effective processing in an automated and controlled environment from start to finish with minimal operator intervention.

About Educell
Educell Ltd, established 1997, is a company focusing on the development of cell therapy products and is a registered cell and tissue establishment. The company is preparing cell therapy products for the treatment of articular cartilage, vesicouretral reflux, regeneration of bone tissue and treatment of immunological disorders, which are in use within the University Medical Centre Ljubljana and other clinical institutions in Slovenia under the “hospital exemption” rule supervised by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia. The company’s R&D department is dedicated to the development of innovative cell therapy products and also to the development of medical devices that enable stem cell isolation and application in the operation theatre.

Educell’s ImmunoArt cell therapy product was developed in 2014 and is based on ex vivo expanded allogeneic mesenchymal stromal/stem cells (MSC) isolated from bone marrow. Its immunomodulatory capacity has already been proven in the clinic for the treatment of graft versus host disease (GvHD) and Chron’s disease. Additional information is available at: https://www.educell.si/en/

About Orgenesis
Orgenesis is a pioneering global biotech company which is unlocking the full potential of personalized therapies and closed processing systems through its Cell & Gene Therapy Biotech Platform, with the ultimate aim of providing life changing treatments at the Point of Care to large numbers of patients at low cost. The Platform consists of: (a) POCare Therapeutics, a pipeline of licensed cell and gene therapies (CGTs), and proprietary scientific knowhow; (b) POCare Technologies, a suite of proprietary and in-licensed technologies which are engineered to create customized processing systems for affordable point of care therapies; and (c) POCare Network, a collaborative, international ecosystem of leading research institutes and hospitals committed to clinical development and supply of CGTs at the point of care. By combining science, technologies and a collaborative network, Orgenesis is able to identify the most promising new therapies and provide a pathway for them to reach patients more quickly, more efficiently and at scale, thereby unlocking the power of cell and gene therapy for all. Additional information is available at: www.orgenesis.com.

Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, our reliance on, and our ability to grow, our point-of-care cell therapy platform, our ability to effectively use the net proceeds from the sale of Masthercell, our ability to achieve and maintain overall profitability, the development of our POCare strategy, the sufficiency of working capital to realize our business plans, the development of our transdifferentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; our technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures; our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading “RISK FACTORS” in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31 2019, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.

SAN FRANCISCO, July 06, 2020 (GLOBE NEWSWIRE) — Vir Biotechnology, Inc. (Nasdaq: VIR), a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases, today announced that it has filed a registration statement on Form S-1 with the Securities and Exchange Commission (SEC) relating to a proposed underwritten public offering of 6,200,000 shares of its common stock. In addition, Vir expects to grant the underwriters a 30-day option to purchase up to 930,000 additional shares of its common stock offered at the public offering price, less the underwriting discounts and commissions. The public offering price has not yet been determined. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Goldman Sachs & Co. LLC, BofA Securities, Cowen and Barclays are acting as joint book-running managers for the proposed offering. Needham & Company is acting as lead-manager for the proposed offering.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the proposed offering may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by email at PostSaleManualRequests@broadridge.com, or by telephone at (833) 297-2926; and Barclays Capital Inc., c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at Barclaysprospectus@broadridge.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,”  “candidate,” “continuing,” “developing” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding, among other things, the timing, size and completion of the proposed public offering.  Many factors may cause differences between current expectations and actual results in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, market risks and uncertainties and the satisfaction of customary closing conditions for an offering of securities. These and other risks and uncertainties are described in Vir’s filings with the SEC, including in the risk factors included in Exhibit 99.2 to its Current Report on Form 8-K filed with the SEC on July 6, 2020. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:
Investors
Neera Ravindran, M.D.
VP, Head of Investor Relations & Strategic Communications 
nravindran@vir.bio
+1-415-506-5256

CAMBRIDGE, Mass. and PHILADELPHIA, July 6, 2020 /PRNewswire/ — Unum Therapeutics Inc. (“Unum”) (NASDAQ: UMRX), a biopharmaceutical company focused on developing therapies for solid tumors, today announced it has completed the acquisition of Kiq LLC (“Kiq”), a privately held, biotechnology company focused on the discovery and development of precision kinase inhibitors. Concurrent with the acquisition of Kiq, Unum entered into a definitive agreement for the sale of Series A non-voting convertible Preferred Stock (the “Series A Preferred Stock”) in a private placement to a group of institutional accredited investors led by Fairmount Funds Management LLC (“Fairmount Funds”), with participation from Venrock Healthcare Capital Partners, BVF Partners L.P., Atlas Venture, Acorn Bioventures, Perceptive Advisor’s LLC, RTW Investments, OrbiMed, Samsara BioCapital, Logos Capital, Ally Bridge Group and Commodore Capital, as well as additional undisclosed institutional investors. The private placement is expected to result in gross proceeds to Unum of approximately $104.4 million before deducting placement agent and other offering expenses. The proceeds from the private placement will be used to advance clinical testing of PLX9486, a highly potent and selective KIT D816V inhibitor, in multiple indications and provide runway beyond 2022.

PLX9486 will be studied as a monotherapy in patients with Advanced Systemic Mastocytosis (ASM) and Indolent Systemic Mastocytosis (ISM), with the goal of demonstrating a best-in-class clinical profile. The therapy has demonstrated promising clinical activity in a Phase 1/2 trial in patients with Gastrointestinal Stromal Tumors (GIST). In a cohort of eighteen 2L+ GIST patients dosed with PLX9486 in combination with sunitinib, median progression free survival (PFS) was eleven months. Additional details from this study are planned for presentation at an upcoming medical meeting.

Worldwide rights to develop and commercialize PLX9486 were exclusively licensed by Kiq from Plexxikon Inc., a member of the Daiichi Sankyo Group. Under the terms of the agreement, Plexxikon received an upfront payment, and is eligible for additional developmental milestones and mid- to high- single-digit royalty payments.

“Unum has explored a range of strategic alternatives through an orderly process to maximize shareholder value, and we believe this acquisition represents the highest-potential value creation opportunity for Unum stockholders. We are excited by Kiq’s lead clinical program and the potential to build a pipeline of novel kinase inhibitors while continuing to explore strategic opportunities for our cell-based therapy programs,” said Chuck Wilson, PhD, President and CEO of Unum. “As the science develops, we will continue to drive forward our mission of developing novel, best-in-class therapeutics for patients with the greatest need, and we thank our Board members, past and present, along with our investors for their support and commitment.”

Management and Organization

Unum management continues to be comprised of a highly experienced team, including Chuck Wilson, PhD, President and Chief Executive Officer, Jessica Sachs, MD, Chief Medical Officer, and John Green, Chief Financial Officer.

In conjunction with the transaction, Unum Board members will include Chris Cain, Director of Research, Fairmount Funds; Karen Ferrante, MD, Medical Oncologist and former biotech executive; Peter Harwin, Managing Member, Fairmount Funds; Arlene Morris, CEO, Willow Advisors; Matthew Ros, Chief Strategy and Business Officer, Epizyme; and Chuck Wilson, PhD, President and CEO, Unum Therapeutics.

“We are excited to successfully complete our review of strategic options at Unum and are pleased to announce the acquisition of Kiq,” said Bruce Booth, DPhil, former Unum board chairman and partner at Atlas Venture. “As Unum’s largest shareholder, Atlas will continue to invest in the company alongside a strong set of new investors, and we look forward to supporting the clinical progress of PLX9486 as a potential new treatment option for patients.”

“With PLX9486 as a cornerstone, we believe we can build a pipeline of potentially best-in-class, precision tyrosine kinase inhibitors and attract the next generation of kinase discovery expertise,” said Peter Harwin, Managing Member, Fairmount Funds. “We look forward to working with Unum to continue its mission of developing best-in-class therapeutics for patients with unmet medical needs.”

About the Transactions

The acquisition of Kiq was structured as a stock-for-stock transaction whereby all of Kiq’s outstanding equity interests were exchanged for a combination of shares of Unum common stock and shares Series A preferred stock. Concurrently with the acquisition of Kiq, Unum entered into definitive agreements for a PIPE investment with existing and new investors to raise $104.4 million in which the investors will be issued shares of Series A Preferred Stock at a price of $880 per share (or, $0.88 per share on an as-converted-to-common basis). The PIPE offering is expected to close on July 9, 2020. Subject to stockholder approval, each share of Series A Preferred Stock will, at the option of the holder, convert into 1,000 shares of common stock, subject to certain beneficial ownership limitations set by each holder. On a pro forma basis and based upon the number of shares of Unum common stock and preferred stock issued in the acquisition and the concurrent financing, Unum equity holders immediately prior to the acquisition will own approximately 16.2% of Unum on a fully-diluted basis immediately after these transactions. The acquisition was approved by the Board of Directors of Unum and the equity holders of Kiq. The closing of the transactions was not subject to the approval of Unum stockholders.

In connection with the transactions, a non-transferrable contingent value right (a “CVR”) will be distributed to Unum stockholders of record as of the close of business on July 6, 2020, and prior to the issuance of any shares to Kiq or the PIPE investors. Holders of the CVR will be entitled to receive certain stock and/or cash payments from proceeds received by Unum, if any, related to the disposition of its legacy cell therapy assets for a period of three years following the closing of the transaction. The CVR is expected to be distributed to eligible stockholders approximately 30 days from the closing of the Kiq acquisition.

Ladenburg Thalmann & Co. Inc. is serving as exclusive financial advisor to Unum and Goodwin Procter LLP is serving as legal counsel to Unum. Wedbush PacGrow is serving as exclusive strategic advisor to Kiq, and Gibson, Dunn & Crutcher LLP is serving as legal counsel to Kiq. Jefferies LLC is acting as lead placement agents for the private placement. Latham & Watkins LLP is serving as legal counsel to Jefferies LLC.

Additional details are available in an updated corporate presentation that can be found online at www.unumrx.com.

Conference Call Details                                                                    

Unum will host a conference call on July 6, 2020, at 10:30 a.m. EDT to discuss the acquisition. To access the call, please dial (866) 300-3411 (toll-free) or (636) 812-6658 (international) and provide the conference ID 5998637. To access the conference call recording, please dial (855) 859-2056 (toll-free) or (404) 537-3406. The archived recording will remain available for replay for 30 days. For more information on the acquisition, please visit the investor section of Unum’s website at www.unumrx.com.

About Unum Therapeutics

Unum Therapeutics is a biopharmaceutical company focused on developing a pipeline of novel therapies to treat cancer patients. Unum’s most advanced program, PLX9486, is a highly potent and selective KIT D816V inhibitor that is being developed to treat systemic mastocytosis and GIST patients. Unum’s cell therapy programs utilize proprietary BOXR technology to improve the functionality of engineered T cells by incorporating a “bolt-on” transgene to overcome resistance of the solid tumor microenvironment to T cell attack. Unum is headquartered in Cambridge, MA.

Follow Unum Therapeutics on social media: @UnumRx and LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: uses of proceeds; projected cash runways; future product development plans; stockholder approval of the conversion rights of the Series A Preferred Stock; and any future payouts under the CVR. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements.  Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Unum’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

SOURCE Unum Therapeutics Inc.

Related Links

http://www.unumrx.com

HOUSTON, July 2, 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 an update on its clinical development plan for Annamycin.

After consultation with both US and European regulatory agencies, Moleculin has mapped out a course for development of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (“AML”).  In its End of Phase 1 meeting with the US Food and Drug Administration (“FDA”) the Company agreed to expand its protocol-mandated testing for cardiotoxicity throughout the remainder of its European Phase 1 trial. The expansion of testing will provide additional safety data, investigating the continued evidence of little to no cardiotoxicity, and efficacy data that both US and European regulators may consider as the Company prepares to transition to a Phase 2 clinical trial, which management believes will focus on Europe.

Moleculin has now received approval from European authorities to increase the increment  for dose-escalation from 30 mg/m² per cohort to 60 mg/m² per cohort, as treatment to date in its clinical trials has been at what the Company considers to be subtherapeutic levels.  The first patient in the European trial has now been treated at 240 mg/m² with no evidence of cardiotoxicity or other dose limiting toxicities.  Once 2 more patients are successfully treated at this level, the next cohort will be treated with 300 mg/m². With these timing and dosing expectations, the Company believes that European dosing will increase in 2020, allowing a recommended Phase 2 Dose to be established in 2021.

“Based on what we know from prior clinical trials, we think it may require a dose level of 300 to 360 mg/m², or possibly higher, before we begin to see a solid therapeutic window for Annamycin in AML,” commented Walter Klemp, Chairman and CEO of Moleculin. “Now, with 5 clinical sites open in Poland, the European trial is in the best position to complete the safety portion of our development. That also allows us to close out the US trial, which has already reached its primary safety endpoint.”

The Company intends to use what it learns from the Phase 1 clinical trials in AML to inform the starting dosage in clinical testing of Annamycin for the treatment of lung metastases, for which it hopes to file an Investigational New Drug application or its European equivalent by the end of this year.

Mr. Klemp concluded: “With the confirmation of animal model activity in lung metastases we just announced last week, we are pushing hard to prepare to seek regulatory approval to begin a Phase 1 clinical trial in sarcomas that have metastasized to the lungs, a condition for which there is a significant unmet need.”

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.

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 to establish a recommended Phase 2 Dose in 2021, the final dose level of such recommended Phase 2 Dose, the ability of Annamycin to show safety and efficacy in patients, and the ability of the Company to file an investigative new drug application or its European equivalent by the end of this year for the treatment of lung metastases. 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.

Contacts
James Salierno / Carol Ruth
The Ruth Group
646-536-7028 / 7000
jsalierno@theruthgroup.com 
cruth@theruthgroup.com

SOURCE Moleculin Biotech, Inc.

Related Links

http://www.moleculin.com

LUND, Sweden, June 30, 2020 /PRNewswire/ — BioInvent International AB (“BioInvent”) (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces it has submitted a clinical trial application (CTA) to begin a Phase I/IIa, first-in-human study of BI-1808, a monoclonal antibody to tumor necrosis factor receptor 2 (TNFR2), as a single agent and in combination with KEYTRUDA^® (pembrolizumab) for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL).

The study will explore the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent and in combination with KEYTRUDA^® in patients with ovarian cancer, non-small cell lung cancer and cutaneous T cell lymphoma. It will also investigate the expression of potential immunological markers that might be associated with clinical responses. It will be conducted at several sites across Europe and the U.S. and is expected to enroll approximately 120 patients.

The Phase I stage is divided into two sections. Part A is a dose escalation of BI-1808 to assess safety, tolerability, and pharmacokinetics & pharmacodynamics, and to determine the recommended dose as a single agent for Phase II trials. It will be followed by part B, which will explore the safety, tolerability and recommended dose of BI-1808 in combination with KEYTRUDA^®. Phase IIa will consist of expansion cohorts to assess signs of efficacy of BI-1808 as single agent and in combination with KEYTRUDA^® in lung cancer and ovarian cancer patients. A separate cohort will explore the activity as single agent in CTCL (Sézary syndrome and mycosis fungoides).

Martin Welschof, CEO of BioInvent, says, “Targeting TNFR2 for cancer therapy is a very promising approach and BI-1808 is a further demonstration of the ability of our proprietary n-CoDeR^® and F.I.R.S.T^TM platforms to generate antibodies with novel, first-in-class mechanisms of action. This Phase I/IIa study of BI-1808 marks the first anti-TNFR2 antibody to enter clinical evaluation. With CTAs filed in Europe, we expect to submit a U.S. IND in the coming months, and to enroll the first patient in Q4 2020.”

About BioInvent

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. Two preclinical programs in solid tumors are expected to enter clinical trials by the end of 2020. The Company’s validated, proprietary F.I.R.S.T technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.

The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company’s fully integrated manufacturing unit. More information is available at www.bioinvent.com.

BioInvent International AB (publ)
Co. Reg. No. Org nr: 556537-7263
Visiting address: Ideongatan 1
Mailing address: 223 70 LUND
Phone: +46-(0)46-286-85-50
www.bioinvent.com

The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.

This information was brought to you by Cision http://news.cision.com

The following files are available for download:

SOURCE BioInvent

HOUSTON, June 25, 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 a presentation at the American Association of Cancer Research (AACR) Annual Meeting held from June 22^nd-24^th, 2020, illustrating a unique approach to creating drugs capable of reaching tumors hiding in organs where existing anticancer drugs cannot accumulate in therapeutic concentrations. A poster presentation entitled, “Targeting Cancer Sanctuary Sites: A Novel Approach to the Treatment of Lung Localized Tumors,” provided an overview of data demonstrating that uniquely high uptake and retention of Annamycin in the lungs results in consistently high in vivo activity against wide range of lung-localized tumors in mice.

“We are very encouraged by this data, as we believe it further demonstrates Annamycin’s anti-cancer activity against tumors that evade therapies that may be initially effective in their primary location of origin, but are protected by metastasis to sanctuary organs.  In the case of sarcomas treated with the current standard of care, doxorubicin, tumors may be initially responsive in their primary location, but become unresponsive after metastasis to the lungs, which eventually becomes the most likely cause of patients’ death,” commented Walter Klemp, Chairman and CEO of Moleculin. “This research also sheds light on why doxorubicin, the current standard of care for many types of cancer, is not effective against lung-localized cancer.  Subsequently, we believe that Annamycin’s ability in animal models to effectively accumulate in the lungs without noticeable side effects offers unique therapeutic opportunities that should be explored for the benefit of cancer patients with lung-localized tumors.”

Mr. Klemp concluded: “One of the reasons we are so excited about Annamycin’s potential to treat lung-localized tumors is its ability in animal models to accumulate in the lungs and lack of toxic side effects related to the high lung accumulation. This was once again confirmed by the data, as Annamycin accumulated in the lungs at nearly 6 times the level of doxorubicin. Importantly, Annamycin’s ability to accumulate in the lungs also led to high anti-tumor activity, which ranged from the inhibition of tumor progression to complete tumor eradication, resulting in significant improvement of survival in all the models tested. We look forward to exploring Annamycin’s clinical potential to target tumors localized in the lungs, one of the most common sites of cancer metastasis.”

The accepted abstract stated, “The high cytotoxic potency of Annamycin against MDR cancer cells is related, in part, to its ability to overcome ABC transporter-mediated efflux and, in contrast to doxorubicin, achieve high intracellular uptake. A greatly increased concentration of Annamycin in the lung, as compared to doxorubicin, leads to high drug efficacy in vivo in lung-localized tumor models. In summary, our studies (1) support the hypothesis of lungs being a sanctuary site for cancer cells and (2) demonstrate that effective targeting of cancers metastatic to the lung is possible by chemical modification of clinically used but currently ineffective drugs, especially in combination with appropriate drug delivery. In more general terms, these studies indicate that the proposed approach can also lead to the identification and elimination of cancer sanctuary sites other than the lungs and creation of more effective anticancer therapies.”

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.

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 Annamycin to show safety and efficacy in patients with lung metastases. 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.

SAN DIEGO and CALGARY, Alberta, June 25, 2020 /CNW/ — Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), today announced a new investigator-sponsored triple-negative breast cancer (TNBC) study to be managed by Rutgers Cancer Institute of New Jersey. The phase 2 trial, known as IRENE, will investigate the use of pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC.

“We are very excited to evaluate pelareorep in TNBC, as prior clinical data show it has the potential to address a pressing unmet need in this challenging indication,” said principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School. “Checkpoint inhibitors targeting interactions between PD-L1 and PD-1, while commercially successful, are ineffective in up to 80% of TNBC patients. This is often due to an immunosuppressive tumor microenvironment. Checkpoint inhibitors are beneficial in patients who have upregulation of PD-L1 expression in the tumor environment. Clinical data show that systemic pelareorep administration can upregulate PD-L1 expression in tumors across multiple breast cancer subtypes, highlighting its potential to substantially increase the percentage of patients who respond to checkpoint inhibitor therapy. Through the IRENE study, we aim to explore how pelareorep-induced adaptive immune responses synergistically interact with PD-1 inhibition to improve patient outcomes in TNBC.”

The newly announced IRENE study represents an expansion of Oncolytics’ lead breast cancer program into a new disease subtype (TNBC). In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality, a previously identified biomarker of pelareorep response that may enable the success of future pivotal studies by facilitating the patient selection process. The trial will take place at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center, and is co-sponsored by Oncolytics, the Rutgers Cancer Institute of New Jersey, and Incyte.

About IRENE

The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the design, purpose, timing and anticipated benefits of the IRENE study; and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

Company Contact
Kirk Look, CFO
Oncolytics Biotech Inc.
+1-403-670-7658
klook@oncolytics.ca  

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-212-915-2564
tim@lifesciadvisors.com

SOURCE Oncolytics Biotech® Inc.

WINNIPEG, Manitoba, June 24, 2020 (GLOBE NEWSWIRE) — Kane Biotech Inc. (TSX-V:KNE; OTCQB:KNBIF) (the “Company” or “Kane Biotech”) today announced that it has been approved for up to $54,750 in funding from the Government of Canada’s CanExport SMEs program. Kane will use this funding to support the marketing costs associated with the U.S. launch of its Human Health anti-biofilm shampoo as well as to support international growth of its Animal Health business.

CanExport SMEs is a program delivered by the Trade Commissioner Service (TCS) of Global Affairs Canada in partnership with the National Research Council’s Industrial Research Assistance Program (NRC-IRAP). It provides direct financial assistance to small and medium-sized businesses registered in Canada in order to help them develop new export opportunities and markets.

“Having reported overwhelmingly positive results from our shampoo consumer product test last month, we are grateful to receive this funding, which will support the product’s launch in the U.S. later this year,” said Marc Edwards, President and Chief Executive Officer of Kane Biotech. “As we prepare to execute our U.S. launch strategy, we are looking forward to making our shampoo available to Canadians, via online direct-to-consumer sales, this summer.”

Kane Biotech’s shampoo was developed based on research indicating that the persistence of microbial biofilm may be linked with aggravating the symptoms associated with atopic dermatitis, seborrheic dermatitis (also known as eczema) and dandruff. The shampoo consists of coactiv+TM, a patented anti-biofilm formulation, and contains ingredients approved as safe for human use.

About Kane Biotech Inc.

Kane Biotech is a biotechnology company engaged in the research, development and commercialization of technologies and products that prevent and remove microbial biofilms. The Company has a portfolio of biotechnologies, intellectual property (51 patents and patents pending, trade secrets and trademarks) and products developed by the Company’s own biofilm research expertise and acquired from leading research institutions. StrixNB, DispersinB®, Aledex®, bluestem, silkstem, coactiv+ and Kane® are trademarks of Kane Biotech Inc. The Company is listed on the TSX Venture Exchange under the symbol “KNE.”

Kane Biotech is a biotechnology company engaged in the research, development and commercialization of technologies and products that prevent and remove microbial biofilms. The Company has a portfolio of biotechnologies, intellectual property (51 patents and patents pending, trade secrets and trademarks) and products developed by the Company’s own biofilm research expertise and acquired from leading research institutions. StrixNB, DispersinB®, Aledex®, bluestem, silkstem, coactiv+ and Kane® are trademarks of Kane Biotech Inc. The Company is listed on the TSX Venture Exchange under the symbol “KNE.”

For more information, please visit www.kanebiotech.com, or contact:

Marc Edwards
Chief Executive Officer
Kane Biotech Inc.
+1 (514) 910-6991
medwards@kanebiotech.com

Ray Dupuis
Chief Financial Officer
Kane Biotech Inc.
+1 (204) 298-2200
rdupuis@kanebiotech.com

Stephen Kilmer
Investor Relations
+1 (646) 274-3580
skilmer@kanebiotech.com

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.

Caution Regarding Forward-Looking Information

This press release contains certain statements regarding Kane Biotech Inc. that constitute forward-looking information under applicable securities law. These statements reflect management’s current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, risks relating to the Company’s: (a) financial condition, including lack of significant revenues to date and reliance on equity and other financing; (b) business, including its early stage of development, government regulation, market acceptance for its products, rapid technological change and dependence on key personnel; (c) intellectual property including the ability of the Company to protect its intellectual property and dependence on its strategic partners; and (d) capital structure, including its lack of dividends on its common shares, volatility of the market price of its common shares and public company costs. Further information about these and other risks and uncertainties can be found in the disclosure documents filed by the Company with applicable securities regulatory authorities, available at www.sedar.com. The Company cautions that the foregoing list of factors that may affect future results is not exhaustive.

COVID-19 Pandemic

The outbreak of COVID-19, the disease caused by the novel SARS-CoV-2 strain of coronavirus, was declared a global pandemic by the World Health Organization on March 11, 2020 and has resulted in a widespread health crisis that has affected economies and financial markets around the world, resulting in an economic downturn. The effects of this pandemic on the Company may include decreased customer demand, interruptions to supply chains, manufacturing activities and research and development programs and increased government regulations or interventions. The duration and impact of the COVID-19 outbreak is unknown at this time and it is not possible to reliably estimate the length and severity of these developments nor the impact of these developments on the financial results and condition of the Company in future periods.

VANCOUVER, British Columbia, June 22, 2020 (GLOBE NEWSWIRE) — WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the “Company” or “WPD”), a clinical stage pharmaceutical company, is pleased to announce that Moleculin Biotech Inc. (“Moleculin”), the company that sublicenses the WP1122 compound to WPD for WPD’s use in 29 countries mainly in Europe, announced on June 16, 2020 that a repeat of previous in vitro testing has corroborated the antiviral potential of WP1122.

Although developing in vitro data is an initial step and the data may not necessarily reflect the antiviral effects in vivo, the results of this repeated round of in vitro testing received by Moleculin on June 1, 2020, confirm that WP1122 has an antiviral effect on Human Coronavirus 229E (“HCoV-229E”), a surrogate of SARS-CoV-2, the virus responsible for COVID-19.

On May 27, 2020, Moleculin announced results from the initial preclinical assessment of the potential for WP1122 to address COVID-19. The testing involved a cell viability assay, followed by a virus yield reduction assay. These tests were intended to assess and compare in vitro antiviral properties of WP1122 and its active moiety (subpart) 2-DG. In this regard, an unedited version of an article that has now been accepted for publication in the scientific journal, Nature (Bojkova, D. et al. Proteomics of SARS-CoV-2-infected host cells reveals therapy targets, Nature https://doi.org/10.1038/s41586-020-2332-7 2020)*, reports that one of the therapeutic targets in SARS-CoV-2 is glycolysis. This work performed by an independent research team at the Göethe-University of Frankfurt further showed that targeting glycolysis with 2-DG stopped replication of SARS CoV-2 in vitro. These results are consistent with previous research reports demonstrating the antiviral activities of 2-DG in other viruses. Moleculin stated that it believes that without the benefit of WP1122’s prodrug structure, 2-DG’s rapid metabolism and limited drug-like properties prevent it from being sufficiently effective in vivo and that in vivo testing of WP1122 may make its benefits more apparent.

Moleculin’s testing was intended to demonstrate the ability of WP1122, a prodrug of 2-DG, to inhibit coronavirus proliferation in a mammalian cell culture. The testing was performed using a surrogate of SARS-CoV-2 called HCoV-229E. Moleculin considers HCoV-229E an appropriate surrogate model for SARS-CoV-2 as both 2-DG and WP1122 are thought to act as both inhibitors of glycolysis and also by altering glycoprotein/glycan structures, including the characteristic spikes found on SARS-CoV-2. Glycans have been shown to form on the outside of the virus and can serve to shield it from the host’s immune system. Additionally, the glycoprotein/glycan spikes present on HCoV-229E and on SARS-CoV-2 appear to perform similar functions in the viral lifecycle. Moreover, 2-DG and WP1122 are also believed to work by inhibiting glycolysis, which is expected to play a similar role in HCoV-229E as it does in SARS-CoV-2.

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, 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, Moleculin stated that it will seek to evaluate WP1122 in an animal model for COVID-19 as a part of its IND preparation. Moleculin further stated “plans to address the FDA’s guidance, both in a second Pre-IND meeting and in an IND submission currently anticipated for the end of 2020. (Moleculin) will seek to conduct a Phase 1a/1b proof-of-concept study, with the Phase 1b being in a relatively small number of early, mild COVID-19 patients.”

WPD has not conducted its own independent confirmation testing of WP1122 and is relying solely on the information contained in Moleculin’s news release dated June 16, 2020 in providing this information to WPD’s shareholders.

*The publication states: “This is an unedited manuscript that has been accepted for publication. Nature Research are providing this early version of the manuscript as a service to our authors and readers. The manuscript will undergo copyediting, typesetting and a proof review before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers apply.”

About WPD Pharmaceuticals

WPD is a biotechnology research and development company with a focus on oncology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has licensed in certain countries 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at institutions, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.

WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things. The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes for most compounds 31 countries in Europe and Asia, including Russia.

On Behalf of the Board

‘Mariusz Olejniczak’

Mariusz Olejniczak
CEO, WPD Pharmaceuticals

Contact:

Investor Relations
Email: investors@wpdpharmaceuticals.com

Tel: 604-428-7050
Web: www.wpdpharmaceuticals.com

Cautionary Statements:
Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company can develop effective drugs against cancer and possibly viruses, and that in vivo testing of WP1122 may make its benefits against SARS-CoV-2 more apparent. Factors which may prevent the forward looking statement from being realized include that competitors or others may successfully challenge a granted patent and the patent could be rendered void; we may be unable to raise sufficient funding for our research; we may be unable to expend sufficient funds on research to keep our sublicense rights; our grant applications may not be successful or if successful, we may not meet the requirements to receive the grants awarded; that our drugs don’t provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com. Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate. Finally, these forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update them except as required by applicable law.

Today, June 16, Massachusetts stem cell biotechnology company Asymmetrex announces that it will begin offering free tissue stem cell counting on its company website. Scheduled for opening July 5, Independence Day weekend in the U.S., the company’s counting site will give academic scientists, stem cell medicine physicians, tissue stem cell suppliers, and drug companies a new independence to begin incorporating exact numbers for tissue stem cell fraction and dosage in their research, stem cell treatments, cell manufacturing, and drug evaluations.

The director of stem cell biotechnology company Asymmetrex, Dr. James L. Sherley, M.D., Ph.D., is betting that if the stem cell medicine and pharmaceutical industries have easier access to stem cell counting, they will soon make it a routine part of their practice. So, starting July 5 of this year, Independence Day weekend in the U.S., Asymmetrex is offering free tissue stem cell counting at its website.

Obtaining a free stem cell count will only require entry of simple total cell count data at the company’s website. Counting total cells is a widely used, common practice throughout academic cell science, industrial cell manufacturing, drug development, and clinical medicine. However, counting tissue stem cells is only possible with Asymmetrex’s AlphaSTEM Test software technology. Simple cell culture procedures will be provided at the free stem cell count site. By following the simple cell culture and total cell counting procedures, any basic cell culture lab can generate the data needed for Asymmetrex to deliver a tissue stem cell-specific count to them in short order.

Asymmetrex’s tissue stem cell counting technology is a recent development for the industry. So, presently, its value is not widely known. There are many examples where the need for tissue stem cell counting has been ignored for years, because previously there was no way to do it. Counting would improve the design and interpretation of tissue stem cell research. Counting tissue stem cells would allow better optimization of cell and tissue manufacturing processes. Counting would provide better quality control for produced and transported tissue stem cell products. Counting would provide crucial dosages for stem cell treatments and stem cell clinical trials. Counting cord blood stem cells would make leukemia treatments for children more reliable. Counting tissue stem cells would provide inexpensive, early identification of stem cell-toxic drug candidates that would fail later in expensive clinical trials.

The planned free stem cell counting site is a part of Asymmetrex’s campaign to increase academic and industry awareness of the need for tissue stem cell counting and its value. In an earlier podcast series on “Counting Stem Cells” featured on the international stem cell industry networking platform RegMedNet, Director Sherley discusses the benefits of Asymmetrex’s technology for stem cell research, stem cell medicine, tissue stem cell biomanufacturing, pharmaceutical development, and environmental health science. Sherley now expects that, “The new free tissue stem cell counting site will give members of our industry the freedom to rediscover, for themselves, the value of counting.”

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. Asymmetrex’s founder and director, James L. Sherley, M.D., Ph.D. is an internationally recognized expert on the unique properties of adult tissue stem cells. The company’s U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems – production and quantification – that have stood in the way of successful commercialization of human adult tissue stem cells for regenerative medicine and drug development. In addition, the portfolio includes novel technologies for isolating cancer stem cells and producing induced pluripotent stem cells for disease research purposes. Asymmetrex markets the first technology for determination of the dosage and quality of tissue stem cell preparations (the “AlphaSTEM Test”) for use in stem cell transplantation therapies, cell biomanufacturing, and pre-clinical drug evaluations. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA and the Massachusetts Biotechnology Council.

NEWS PROVIDED BY AVM Biotechnology, LLC  Jun 17, 2020, 13:08 ET

SEATTLE, June 17, 2020 /PRNewswire/ — Oxford University announced yesterday that dexamethasone could reduce deaths in the sickest COVID-19 patients. The World Health Organization (WHO) and others from around the world are looking closely at this generic corticosteroid as a global treatment for those severely ill with COVID-19.

AVM Biotechnology’s lead molecule is a purified loaded formulation of dexamethasone. AVM is actively studying dexamethasone and has found that in higher, single doses, it can be safely administered and appears to have a different Mechanism of Action (MOA) than chronic, repeat, lower doses. AVM has seen some success in cancer models and the Oxford study reinforces what we already know about dexamethasone. Based on its MOA in preclinical models, we have reason to believe it will have an even greater impact in COVID-19 patients than standard dexamethasone. The information coming from Oxford University solidifies our hypothesis that AVM0703 could prove effective against COVID-19.

We are filing with the FDA to proceed with clinical trials against this virus. AVM0703 has already been approved for clinical trials in treating terminal no option non-Hodgkins lymphoma. The Oxford research further underscores the need for testing of AVM0703 at higher doses in COVID patients. AVM0703, a repurposed formulation of an active ingredient, dexamethasone, that is already FDA approved for other uses, used at supra-pharmacologic doses has a novel mechanism of action (MOA) to uniquely mobilize supercharged immune cells that are 10X more efficient than normal immune cells. These supercharged immune cells include a novel Natural Killer T (NKT) cell, novel cytotoxic T lymphocytes and a CD11b very high dendritic cell, which invade and destroy tumors more effectively than untreated immune cells, than PD-1 or PD-L1 inhibitor treatments (checkpoint inhibitors), and standard of care chemotherapy.

Long term immunity is triggered and when mice are re-challenged with the same tumor over 100 days later, memory immune cells attack and kill the tumor. NKT cells and cytotoxic T lymphocytes are by nature programmed to kill viruses and bacteria as well as cancer. The combination of these three mobilized supercharged immune cells could kill the COVID-19causing virus (SARS CoV2) and induce long-term immunity. AVM0703, a purer, enhanced formulation of dexamethasone enables single acute doses to replace chronic repeat dosing. This dosing could potentially save more lives than repeat 10-day dosing and could also reduce ICU days from 10+ days to 2-3 days, which would be a significant financial impact benefiting healthcare systems and patients.

AVM0703 can be manufactured in seven hours, is produced for AVM Biotechnology by a global contract development and manufacturing organization (CDMO) and is stable even at temperatures of 40degC (104degF) and high humidity, which make it a potential global solution for the current pandemic and for possible future pandemics.

“Drugs such as AVM0703 that mobilise endogenous supercharged natural killer cells, cytotoxic T cells and dendritic cells provide a potential solution for the treatment of seriously ill COVID19 patients, are available, have safety data, and are registered for the treatment of other diseases. It is in this area that large scale studies should be undertaken as they can be used to immediately treat patients together with other interventions. Such drugs are also potentially useful in other infectious disease settings where vaccines and antiviral drugs are ineffective or unavailable.”   Dr. Gary Grohmann, Former WHO Advisor & Consultant, former Director of Immunobiology and the WHO ERL at the TGA, Director of the Immunisation Coalition and Director/Founder of Environmental Pathogens.

Contact Jena Dalpez Jdalpez@avmbiotech.com

ALL INFORMATION CONTAINED HEREIN HAS BEEN PROVIDED BY THE COMPANY AND NO OTHER PARTY HAS INDEPENDENTLY VERIFIED ANY OF THE INFORMATION, INCLUDING THE FINANCIAL ESTIMATES AND PROJECTIONS CONTAINED HEREIN.  SOME OF THE STATEMENTS IN THE MEMORANDUM ARE “FORWARD-LOOKING STATEMENTS.”  THESE FORWARD-LOOKING STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO, STATEMENTS ABOUT THE COMPANY’S PLANS, OBJECTIVES, EXPECTATIONS AND INTENTIONS AND OTHER STATEMENTS CONTAINED IN THE MEMORANDUM THAT ARE NOT HISTORICAL FACTS.  WHEN USED IN THIS MEMORANDUM, THE WORDS “ASSUMES,” “ANTICIPATES,” “BELIEVES,” “CONTINUE,” “COULD,” “EXPECTS,” “FORECASTS,” “INTENDS,” “MAY,” “PLANS,” “SEEKS,” “SHOULD,” OR “WILL” OR THE NEGATIVE OF THESE TERMS OR SIMILAR EXPRESSIONS ARE GENERALLY INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS.  BECAUSE THESE FORWARD-LOOKING STATEMENTS INVOLVE RISKS AND UNCERTAINTIES, THERE ARE IMPORTANT FACTORS THAT COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE EXPRESSED OR IMPLIED BY THESE FORWARD-LOOKING STATEMENTS, INCLUDING THE COMPANY’S PLANS, OBJECTIVES, EXPECTATIONS AND INTENTIONS AND OTHER FACTORS DISCUSSED UNDER “RISK FACTORS” SUCH STATEMENTS, ESTIMATES AND PROJECTIONS REFLECT VARIOUS ASSUMPTIONS OF THE COMPANY THAT MAY OR MAY NOT PROVE TO BE CORRECT. AND NO REPRESENTATION IS MADE AND NO ASSURANCE CAN BE GIVEN THAT THE COMPANY CAN OR WILL ATTAIN SUCH RESULTS.

Both of these COVID-19 diagnostic tests are being developed under the collaboration agreement with Tauriga Sciences Inc. (OTCQB: TAUG) (“Tauriga”).

NEW YORK, NY and SAN DIEGO, CA, June 18, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Aegea Biotechnologies, Inc. (“Aegea”) (www.aegeabiotech.com), a biotechnology company focusing on the development and commercialization of next generation nucleic acid clinical diagnostic technologies, announces progress on the development of two COVID-19 diagnostic tests, each applying technology from different issued Aegea patents. Both of these COVID-19 diagnostic tests are being developed under the collaboration agreement with Tauriga Sciences Inc. (OTCQB: TAUG) (“Tauriga”).

The high-sensitivity, high specificity COVID-19 PCR assay under development (the “SARS-CoV-2 Test”) utilizes technology from US Patent 9,834,817, entitled METHODS FOR DETECTING NUCLEIC ACID SEQUENCE VARIANTS. This assay is designed to be run on most PCR-based instrument platforms. Aegea is applying its patented and clinically validated technology to deliver an enhanced level of genetic information without sacrificing time or introducing any cumbersome processing steps. The key advantages of the higher level of sensitivity and specificity are reduction or elimination of false positive and false negative results, the ability to identify which strain of SARS-CoV-2 is present, and the potential to use oropharyngeal swabs or lavage samples instead of nasal swabs. Oropharyngeal swabs would be much more convenient and comfortable for patients, but they have lower viral loads.

Aegea has selected its gene target region for its SARS-CoV-2 Test and has already configured the assay. Aegea is in the process of optimizing assay performance and is working with a certified CLIA laboratory to analytically and clinically validate the assay using COVID-19 patient samples.

In addition to the high sensitivity, high specificity PCR-based SARS-CoV-2 Test, Aegea is using another of its patented technologies to further expand COVID-19 testing to very simple devices appropriate to point-of-care and remote testing (the “Lateral Flow CoV Test”). This assay is designed to be widely accessible by providing results within 30 minutes using a small, portable device, without the requirement for PCR instrumentation. The Lateral Flow CoV Test uses isothermal amplification as covered by Aegea’s issued US Patent 10,174,352 for METHODS FOR AMPLIFICATION OF NUCLEIC ACIDS ON SOLID SUPPORT. This methodology combines the capture of nucleic acid targets of interest, together with isothermal amplification on solid surfaces. Because this method works at a single uniform temperature, it can be used with a very simple lateral flow device in point of care and remote settings. The technology works directly with RNA targets, which is suitable for COVID-19 testing, as the SARS-CoV-2 genome is a single stranded RNA.

Aegea has made good initial progress in its development of the Lateral Flow CoV Test. The assay steps have been outlined, and the initial specifications for the microfluidics component and the initial design for the overall device have been completed. Importantly, Aegea is currently in the process of doing feasibility studies for using saliva (without the need for swabs or collection tubes) for the Lateral Flow CoV Test.

“We believe that Aegea’s patented technologies can be utilized to provide two different COVID-19 tests,” said Lyle Arnold, Ph.D., Aegea’s President and CEO. “The high sensitivity PCR based test will provide accurate, more nuanced genetic information, which can be useful in managing disease spread in the current and future pandemics. The isothermal, lateral flow test can enable frequent testing in convenient settings with low instrumentation requirements.”

Tauriga’s CEO, Mr. Seth Shaw, states, “Tauriga strongly believes that each of Aegea’s tests in development has significant market potential. We continue to be enthusiastic about the progress being realized, with respect to its Collaboration Agreement with Aegea.”

ABOUT AEGEA BIOTECHNOLOGIES, INC.

Aegea Biotechnologies, Inc. located in San Diego, California, is a biotechnology company focusing on the development and commercialization of next generation nucleic acid technologies. A primary focus for the company is nucleic acid technology innovations that embrace molecular diagnostic assays, qPCR technologies, sequencing methods including both Sanger and NGS, and rapid point-of-care COVID-19 testing.

ABOUT TAURIGA SCIENCES INC.

Tauriga Sciences, Inc. (TAUG) is a revenue generating, diversified life sciences company, engaged in several major business activities and initiatives. The company manufactures and distributes several proprietary retail products and product lines, mainly focused on the Cannabidiol (“CBD”) and Cannabigerol (“CBG”) Edibles market segment. The main product line, branded as Tauri-Gum, consists of a proprietary supplement chewing gum that is both Kosher certified and Vegan formulated (CBD Infused Tauri-Gum Flavors: Mint, Blood Orange, Pomegranate) & (CBG Infused Tauri-Gum Flavors: Peach-Lemon and Black Currant). The Company’s commercialization strategy consists of a broad array of retail customers, distributors, and a fast-growing E-Commerce business segment (E-Commerce website: www.taurigum.com). Please visit our corporate website, for additional information, as well as inquiries, at www.tauriga.com.

Complementary to the Company’s retail business, are its two ongoing biotechnology initiatives. The first one relates to the development of a Pharmaceutical grade version of Tauri-Gum, for nausea regulation (specifically designed to help patients that are subjected to ongoing chemotherapy treatment). On March 18, 2020, the Company announced that it filed a provisional U.S. patent application covering its pharmaceutical grade version of Tauri-Gum. The Patent, filed with the U.S.P.T.O. is Titled “MEDICATED CBD COMPOSITIONS, METHODS OF MANUFACTURING, AND METHODS OF TREATMENT”. The second one relates to a collaboration agreement with Aegea Biotechnologies Inc. for the co-development of a rapid, multiplexed, Novel Coronavirus (COVID-19) test with superior sensitivity and selectivity.

The Company is headquartered in New York City and operates a regional office in Barcelona, Spain. In addition, the Company operates a full-time E-Commerce fulfillment center located in LaGrangeville, New York.

DISCLAIMER — Forward-Looking Statements

This press release contains certain “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995 which represent management’s beliefs and assumptions concerning future events. These forward-looking statements are often indicated by using words such as “may,” “will,” “expects,” “anticipates,” believes, “hopes,” “believes,” or plans, and may include statements regarding corporate objectives as well as the attainment of certain corporate goals and milestones. Forward-looking statements are based on present circumstances and on management’s present beliefs with respect to events that have not occurred, that may not occur, or that may occur with different consequences or timing than those now assumed or anticipated. Actual results may differ materially from those expressed in forward looking statements due to known and unknown risks and uncertainties, such as are not guarantees of general economic and business conditions, the ability to successfully develop and market products, consumer and business consumption habits, the ability to consummate successful acquisition and licensing transactions, fluctuations in exchange rates, and other factors over which Tauriga has little or no control. Many of these risks and uncertainties are discussed in greater detail in the “Risk Factors” section of Tauriga’s Form 10-K and other filings made from time to time with the Securities and Exchange Commission. Such forward-looking statements are made only as of the date of this release, and Tauriga assumes no obligation to update forward-looking statements to reflect subsequent events or circumstances. You should not place undue reliance on these forward-looking statements.

CONTACT INFORMATION:

TAURIGA SCIENCES, INC.

555 Madison Avenue, 5th Floor
New York, NY 10022
Chief Executive Officer
Mr. Seth M. Shaw
Email: sshaw@tauriga.com
cell # (917) 796 9926
Instagram: @taurigum
Twitter: @SethMShaw
Corp. Website: www.tauriga.com
E-Commerce Website: www.taurigum.com

AEGEA BIOTECHNOLOGIES, INC.

Stella M. Sung, Ph.D.
Chief Business Officer
Email: ssung@aegeabiotech.com
Corp. Website: www.aegeabiotech.com

TORONTO, ON / ACCESSWIRE / June 15, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received expedited approval from Health Canada to begin a Phase 2/3 clinical study of its investigational drug, EB05, which the company is developing as a potential treatment for moderate to severe COVID-19 patients. The company reported that it has EB05 drug product available now and is seeking government grants to accelerate the initiation and rollout of the study, beginning at up to 30 sites.

EB05 is a monoclonal antibody that has demonstrated the ability to suppress the release of proinflammatory cytokines that are often observed in severe COVID-19 patients. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling – a key component of the innate immune system and an important mediator of inflammation responsible for acute lung injury that has been shown to be activated during SARS and Influenza infection. Based on previous clinical data and the mechanism of action, the company believes that modulating this well understood signaling pathway could reduce the number of ICU patients and intubation/ventilation procedures, ultimately saving lives. The safety and tolerability of EB05 have been demonstrated previously in over 120 subjects.

As planned, Edesa’s Phase 2/3 study will be an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized patients with moderate to severe COVID-19. The company plans to enroll up to 355 patients in the first phase of the trial. Patients will be infused intravenously with EB05 or placebo. Should the drug treatment demonstrate promising results at the Phase 2 readout, the protocol allows for enrollment to continue as a pivotal Phase 3 study.

“Health Canada’s expedited review process and subsequent approval of our Clinical Trial Application represents a significant step in developing new drugs that can treat the underlying conditions induced by the SARS-CoV-2 infection,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “We greatly appreciate the actions being taken by the government to expedite COVID-19 applications and provide support for clinical studies.”

Dr. Nijhawan explained that COVID-19 patients often have inflammation and injury to the lungs as a result of an overactive immune response, sometimes described as a “cytokine storm.” Moderate to severe patients often progress to ARDS (acute respiratory distress syndrome), a life-threatening form of respiratory failure, and the leading cause of death in COVID-19 patients. Countering this cytokine storm in hospitalized COVID-19 patients has been a key area of interest among researchers. There are currently few meaningful treatments for ARDS, other than supplemental oxygen and mechanical ventilation.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. Edesa’s lead product candidate, EB01, is a novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor) for the treatment of chronic allergic contact dermatitis which has demonstrated statistically significant improvements in multiple clinical studies. The company is developing late-stage monoclonal antibodies that block certain immune signaling proteins, known as TLR4 and CXCL10. These molecules are associated with a broad range of diseases, including infectious diseases. Due to the global health emergency, Edesa has prioritized the development these antibodies as potential treatments for moderate to severe COVID19 patients. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California. Sign up for news alerts.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s plans to seek grant funding and initiate new clinical studies in COVID-19 patients. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

Contacts
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com

SOURCE: Edesa Biotech

U.S. FDA Approves Company’s Expanded Access Protocol to Treat Additional Patients

LOS ANGELES, April 29, 2020 (GLOBE NEWSWIRE) — Capricor Therapeutics (“Capricor”) (NASDAQ: CAPR) a clinical-stage biotechnology company focused on the development of first-in-class biological therapeutics for the treatment and prevention of diseases, announced today new data reporting 100 percent survival in critical COVID-19 patients who were treated with Capricor’s lead asset, off-the-shelf (“allogeneic”) cardiac cell therapy CAP-1002, at Cedars-Sinai Medical Center as part of six compassionate care cases.

Over the course of one month, six critically ill COVID-19 patients, all suffering from acute respiratory distress syndrome (ARDS) and five of whom were on mechanical ventilatory support, were safely treated with CAP-1002. Of the six patients treated, four of them have been discharged. Following a review of the available data, the U.S. Food and Drug Administration (FDA) approved the Company’s expanded access protocol to treat up to 20 additional COVID-19 patients. There is also a randomized, placebo-controlled trial planned to treat patients with moderate and severe disease which is intended to be funded by non-equity capital.

In the compassionate care cases, five male patients and one female patient (between ages 19 and 75) suffering from COVID-19 received IV infusions of 150 million allogeneic cardiosphere-derived cells (CAP-1002). Of the five patients on ventilator support, four patients no longer required ventilator support within just one to four days following the infusion. The fifth patient remains on mechanical ventilation and the sixth patient is receiving supplemental oxygen and is currently clinically stable. Additionally, laboratory biomarkers correlated with poor outcomes were measured in all patients. Following infusion, several patients showed improvements in biomarkers, such as ferritin, absolute lymphocyte counts and CRP. No adverse events related to the administration of CAP-1002 were observed. This data has been submitted for publication.

CAP-1002 demonstrates immunomodulatory properties. Multiple published peer-reviewed studies of CDCs have demonstrated favorable modulation of various inflammatory cytokines and regulation of the immune response. The current understanding of COVID-19’s later stages are thought to be due to overstimulation of the immune system, which triggers a cytokine storm in which the body is overwhelmed with pro-inflammatory molecules. This immune response may become excessive and pathologic, inducing pneumonia, organ failure and death. Therefore, it can be the body’s overreaction to COVID-19, rather than the virus itself, that delivers the fatal blow.

“As the global medical community continues to come together in its battle against COVID-19, the results of our initial compassionate care cases are extremely promising and what we had anticipated. We look forward to continuing to treat additional patients under our recently approved expanded access program Investigational New Drug application,” said Dr. Linda Marbán, Ph.D., CEO, Capricor. “CAP-1002 is an easy-to-deliver intravenous therapy that has been administered successfully to over 150 patients to date. Given its novel mechanism of action, it could be a potential game-changer in helping countless COVID-19 patients.”

Capricor is also in late-stage clinical development of CAP-1002 for Duchenne muscular dystrophy (DMD). In DMD, the lack of dystrophin produces abnormal inflammatory responses, which are responsible for much of the damage to skeletal and cardiac muscle. The Company has previously announced that top-line results of HOPE-2, a randomized, placebo-controlled study, will be released by mid-May 2020.

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class biological therapeutics for the treatment and prevention of diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy. Capricor is also investigating the field of extracellular vesicles and exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. For more information, visit www.capricor.com and follow the Company on Facebook, Instagram and Twitter.

About CAP-1002

CAP-1002 consists of allogeneic “off-the-shelf” cardiosphere-derived cells, or CDCs, a type of cardiac cell therapy that has been shown in pre-clinical and clinical studies to exert potent immunomodulatory activity. It is being investigated for its potential to modify the immune system’s activity to encourage cellular regeneration. The cells function by releasing exosomes that are taken up largely by macrophages and T-cells and begin a cycle of repair. CDCs have been the subject of over 100 peer-reviewed scientific publications and administered to approximately 150 human subjects across several clinical trials.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, revenue projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings, and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the Securities and Exchange Commission on March 27, 2020. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor’s exosome-based candidates have been approved for clinical investigation.

For more information, please contact:

Media Contact:
Caitlin Kasunich
KCSA Strategic Communications
ckasunich@kcsa.com
212.896.1241

Investor Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
617.435.6602
Company Contact:
AJ Bergmann, Chief Financial Officer
abergmann@capricor.com
310.358.3200

Source: Capricor Therapeutics
© 2020 GlobeNewswire, Inc.

WALTHAM, Mass.–(BUSINESS WIRE)– ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Mark Enyedy, President and CEO, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming RBC Capital Markets Global Healthcare Virtual Conference. The presentation is scheduled for May 19, 2020 at 10:20am ET.

A webcast of the presentation will be accessible through the Investors and Media section of the Company’s website on www.immunogen.com. Following the live webcast, a replay will be available at the same location.

ABOUT IMMUNOGEN

ImmunoGen is developing the next generation of antibody-drug conjugates to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to “target a better now.”

Learn more about who we are, what we do, and how we do it at www.immunogen.com.

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INVESTOR RELATIONS AND MEDIA
ImmunoGen
Courtney O’Konek
781-895-0600
courtney.okonek@immunogen.com

OR

FTI Consulting
Robert Stanislaro
212-850-5657
robert.stanislaro@fticonsulting.com

Source: ImmunoGen, Inc.

Rapid advancement of clinical program for the treatment of ARDS based on prior clinical data reflecting favorable tolerability data and meaningful benefits on mortality, ventilator-free days and ICU-days

CLEVELAND–(BUSINESS WIRE)– Athersys, Inc. (NASDAQ: ATHX) announced today that the first patients have been enrolled in Athersys’ pivotal Phase 2/3 study entitled, MultiStem® Administration for COVID-19 Induced Acute Respiratory Distress Syndrome (MACOVIA). The patients were enrolled at University Hospital’s Cleveland Medical Center (UH Cleveland), a leading pulmonary critical care center and a nationally ranked hospital. Medpace, a leading contract research organization (CRO) based in Cincinnati, Ohio, is serving as the CRO for this study.

With the continued spread of COVID-19 and the resulting cases of severe respiratory distress among those patients that become seriously ill, there is an immediate need for therapies. The Company’s program evaluating administration of MultiStem for the treatment of ARDS was recently granted Fast Track designation by the FDA based on the promising Phase 1/2 data from its previously completed MUST-ARDS trial. Currently there are no FDA-approved medicines for the treatment of ARDS.

“New treatment options are needed for patients with severe COVID-19 induced ARDS. However, it is important that potential therapies are scientifically evaluated as part of a clinical trial,” commented Site Principal Investigator, Dr. Frank Jacono, MD, Associate Professor of Medicine and a Pulmonary and Critical Care Medicine Physician at University Hospitals Cleveland and the Cleveland VA Medical Center. “We are pleased to partner with Athersys to advance this important clinical study to evaluate treatment of critically ill patients with COVID-19-induced ARDS,” concluded Dr. Jacono.

Other MACOVIA clinical investigators at UH Cleveland include Dr. Rana Hejal, MD, Pulmonary and Critical Care Medicine Specialist and Medical Intensive Care Unit (MICU) Director, Dr. Catalina V. Teba, MD and Dr. Olivia Giddings, MD, PhD, both Pulmonary and Critical Care Medicine Specialists.

This study is designed to enroll approximately 400 subjects. The first patients were enrolled into the first cohort of the study, which is an open-label, single active treatment arm to evaluate the safety of MultiStem administered at two dose levels to study subjects with moderate to severe ARDS associated with COVID-19. If the treatment is well tolerated in this first cohort, the study is designed to further evaluate MultiStem efficacy, safety and tolerability in this patient population using a robustly powered, double-blind, randomized and placebo-controlled trial protocol.

The primary efficacy endpoint for the MACOVIA study will compare the number of ventilator-free days through day 28 among MultiStem and placebo treatment groups. Secondary objectives of the study are to evaluate 60-day all-cause mortality, time in the intensive care unit, pulmonary function, tolerability and quality of life (QoL) among survivors through one-year of follow-up.

MultiStem cell therapy’s potential for multidimensional therapeutic impact may distinguish it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. Since MultiStem is not virus- or pathogen-specific, it may have the potential to treat ARDS that develops from a variety of causes, including COVID-19, as well as other pathogen-induced or non-infectious causes of severe lung inflammation leading to ARDS. The Company is in discussions with the Biomedical Advanced Research and Development Authority (BARDA) to expedite the advancement of MultiStem to treat patients with ARDS resulting from the COVID-19 epidemic and other potential pandemic outbreaks. For more detailed information on the Company’s ARDS program, please visit the ARDS page on the Athersys website.

About ARDS

ARDS is a serious respiratory condition characterized by widespread inflammation in the lungs. ARDS can be triggered by pneumonia, sepsis, trauma, or other events and represents a major cause of morbidity and mortality in the critical care setting. ARDS is associated with a high mortality rate and significant long-term complications and disability among survivors. Among survivors, the condition prolongs ICU and hospital stays and often requires extended convalescence in the hospital and rehabilitation care settings. There are limited interventions and no effective drug treatments for ARDS. There is a large unmet need for a safe treatment that can reduced mortality and improve Quality of Life (QoL) for those surviving ARDS. Additionally, given the high healthcare resource burden associated with treatment of ARDS patients, a successful therapy could be expected to generate significant savings for the healthcare system by reducing days on a ventilator and in the ICU, or in the setting of a widespread high pathogenicity respiratory virus pandemic, make those resources more rapidly available to other patients.

About COVID-19

COVID-19 is the infectious disease caused by the most recently discovered human coronavirus, SARS-CoV-2. This new disease was unknown before the outbreak was first discovered in Wuhan, China, in December 2019. Older people and those with underlying medical problems such as high blood pressure, heart problems or diabetes, are more likely to develop serious illness, but even young, previously healthy people can suffer severe disease and complications such as ARDS. Data are still emerging, but recently published case series suggest mortality rates among COVID-19 patients who develop ARDS may be 50% to 70%, or perhaps even higher in some environments.

About MultiStem®

MultiStem® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. MultiStem therapy’s potential for multidimensional therapeutic impact may distinguish it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. MultiStem represents a unique “off-the-shelf” stem cell product candidate that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon favorable efficacy data, its novel mechanisms of action, and favorable and consistent tolerability data in clinical studies, we believe that MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.

About Medpace

Medpace is a scientifically driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 3,600 people across 37 countries.

About Athersys

Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product, initially for disease indications in the neurological, inflammatory and immune, cardiovascular and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization. More information is available at www.athersys.com. Follow Athersys on Twitter at www.twitter.com/athersys.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “suggest,” “will,” or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: the success of our MACOVIA study; our ability to raise capital to fund our operations; our ability to successfully finalize and implement an alliance with BARDA, and the terms of any such alliance, including the amount, if any, of funding that we might receive; the timing and nature of results from MultiStem clinical trials, including our MASTERS-2 Phase 3 clinical trial and the HEALIOS K.K. (Healios) TREASURE and ONE-BRIDGE clinical trials in Japan; the impact on our business, results of operations and financial condition from the ongoing and global COVID-19 pandemic, or any other pandemic, epidemic or outbreak of infectious disease in the United States; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials of our product candidates; the possibility of delays, work stoppages or interruptions in manufacturing by third parties or us, such as due to material supply constraints or regulatory issues, which could negatively impact our trials and the trials of our collaborators; uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem cell therapy for the treatment of ischemic stroke, ARDS, acute myocardial infarction and trauma, and the prevention of graft-versus-host disease and other disease indications; changes in external market factors; changes in our industry’s overall performance; changes in our business strategy; our ability to protect and defend our intellectual property and related business operations, including the successful prosecution of our patent applications and enforcement of our patent rights, and operate our business in an environment of rapid technology and intellectual property development; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our ability to meet milestones and earn royalties under our collaboration agreements, including the success of our collaboration with Healios; our collaborators’ ability to continue to fulfill their obligations under the terms of our collaboration agreements and generate sales related to our technologies; the success of our efforts to enter into new strategic partnerships and advance our programs, including, without limitation, in North America, Europe and Japan; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.

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Ivor Macleod
Chief Financial Officer
Tel: (216) 431-9900
ir@athersys.com
Karen Hunady
Director of Corporate Communications & Investor Relations
Tel: (216) 431-9900
khunady@athersys.com
David Schull
Russo Partners, LLC
Tel: (212) 845-4271 or (858) 717-2310
David.schull@russopartnersllc.com

Source: Athersys, Inc.

© Copyright Business Wire 2020

Since charting a course to reinvent its business model two years ago, Oculus Innovative Sciences (NASDAQ: OCLS) hasn’t pulled any punches about how it expects to achieve success.  Front and center in the plan has been the U.S. dermatology market.  In order to capture as much of this market as possible, Oculus needed more control, which meant ending existing relationships and bringing its sales force in-house.  Management made it clear that it intended to leverage non-core operations, which primarily were made up of ex-U.S. derm and animal care product sales, to reach a cash flow positive position with its U.S. derm business.

If a company is measured by its promises, then Oculus is standing tall in its turnaround effort, as it has yet to deliver an unimpressive quarterly report with respect to meeting its goals.

Keeping the pace of introducing one new product to the market about every quarter, Oculus now 15 clearances from the U.S. Food and Drug Administration to commercialize products based upon its core Microcyn® Technology or selective technology in-licensed from partners.  New product launches are on the horizon, including treatments for skin descaling and, post-Mohs procedure and atopic dermatitis (eczema).

The graph below (sourced from the current Oculus Fact Sheet) lends some color to the growth curve resulting from market penetration and product launches.  These data are underscored by a seasoned sales team – now 22 members strong – capturing more than 550 heavy-prescription-writing dermatologists that has led to over 58,000 prescriptions being filled in the past two years.  All told, more five million patients globally have been treated with Oculus products.  Helping to get the Oculus products in the hands of patients are some of the biggest wholesalers in the business, including McKesson, Cardinal and AmerisourceBergen.

Q2 Fiscal 2017:  Seeing the Vision Take Shape

Oculus recently released the results from its second quarter of fiscal year 2017, ended September 30, 2016.  The results mirrored growth from each quarter since the re-build started two years, driven by the main objective of growth in U.S. dermatology.

During the quarter, total revenue rose to $4.11 million, up from $4.05 million in the year prior quarter.  While the headline increase was only about 1.5 percent, the improvement was the result of increased U.S. sales offsetting declining international revenue.  Product revenue in the U.S. totaled $1.7 million, representing an increase of 43 percent from Q2 fiscal 2016.

Product revenue from Latin America, which used to be the largest sales region for Oculus, was hurt by persistent weakness in the Mexican peso.  Revenue declined 6 percent to $1.2 million, as a 9 percent increase in local currency revenue wasn’t enough to outweigh a 15 percent year-over-year decline in the value of the peso.  Revenue from Europe and the rest of the world during the quarter eked lower by 3 percent to $920,000.

Oculus reported gross profit of $2.1 million, of 51% of revenue, for the second quarter, essentially matching gross profit (52%) from the year earlier quarter.  The tepid reduction was attributed to Oculus progressively eliminating licensing fees and royalty revenue.  While they come with higher margins, they also come with restricted control of product sales, which is one component Oculus was aiming to minimize as part of the business restructuring.

Adjusted net loss for the quarter, which doesn’t include non-cash expenses, was $1.5 million, up $171,000 from the year prior quarter.

For the first six months of fiscal 2017, total revenue was up $185,000 to $7.9 million.  Aligned with the overall plan, product revenue in the U.S. was the horse pulling the cart, gaining $1.1 million, or 56 percent, from the comparable period in fiscal 2016.  Sales from Europe and rest of world chipped in with 29 percent growth, while Latin American sales fell 19 percent mostly due to an 18 percent drop in the value of the Mexican peso.

Enough Cash to Reach Breakeven

In the turnaround strategy, the first major milestone is reaching breakeven in the U.S. derm business.  This is no small feat, considering that Oculus adopted a plan that essentially stripped this sales channel to zilch before launching eight new products into the medical dermatology market through a direct sales force.  Moreover, even a highly experienced salesperson takes time to cover their own costs.  Oculus has articulated that it takes about nine months to reach breakeven on a sales force investment.

Now about 24 months into the turnaround, Oculus is reaching a key tipping point.  In order to get there, Oculus management demonstrated its commitment to the U.S. markets as the value driver and future of the company by selling its Latin American business to Invekra S.A.P.I. de C.V. of Mexico in October for $19.5 million in cash plus royalties on certain net sales for the next 10 years.

In the deal, Oculus sold to Invekra all of its assets related to its Microdacyn®-based products sold throughout Latin America and the Caribbean, while maintaining rights to sales of dermatology products in Brazil, the second largest derm market in the world outside the U.S.

Oculus collected $18.0 million upfront with another $1.5 million put in escrow to be transferred upon Oculus delivering certain equipment to Invekra, expected in February 2017.  Further, Oculus will collect a 3 percent royalty on all Latin American revenue outside of Mexico for the next decade.  The royalty payment has a floor of $250,000 annually, payable each quarter to Oculus in Mexican pesos, adding a minimum of another $2.5 million to the price of the divestiture.  Privately-held Invekra is part of the Mexican pharma giant Grupo Invekra, which also operates Oculus distribution partner Laboratorios Sanfer S.A. de C.V.  Overall, Invekra has nearly 3,000 employees working in 10 different Latin American countries, meaning that there is an opportunity for royalties to exceed the $250,000 annually going forward.

While the cash didn’t make it to the books for the September quarter, it does mean that Oculus entered November with about $21 million in unrestricted cash and cash equivalents with another $1.5 million expected early in 2017.  In the conference call discussing the latest quarter, Oculus CEO Jim Schutz conveyed that the cash is “more than three times the amount of money we need to achieve commercial breakeven and operating profitability company-wide.”  Mr. Schutz also noted that in Oculus is already breakeven in all of its non-core businesses (hospital sales, animal health sales, contract lab sales and international sales).

Technical Traders Note New Uptrend Since August

Despite some spikes here and there, the market has been slow to reward Oculus with a market valuation that is typical for the industry, which generally runs at 3x-6x revenue.  In fact, with a market capitalization of $19.75 million as on Friday’s close, Oculus is valued beneath its cash value, considering it has essentially no debt.

The technical chart for OCLS is giving hints that Wall Street is taking notice of the fundamental developments.  The area of $3.90 is an established area of support and since dipping to $3.57 in August, the chart is making a pattern of higher highs and higher lows.

This movement since August puts the OCLS chart in a position to try and break a downtrend going back to August 2015.  A key resistance level is $5.00, with a move through and hold above resistance at $5.50 a pretty strong technical sign that the downtrend has ended and a new uptrend is underway.

Now More Than Ever:  Emphasis on U.S.

The convergence of fundamentals and technicals can be a powerful phenomenon in the stock market.  Oculus certainly is pointed that direction with the aforementioned data complemented by facts such as 60% average quarter-over-quarter demand dollar growth in the past four quarters and U.S. product sales growing 121% in the full year fiscal 2016 compared to fiscal 2015.

Divesting the Latin American assets puts Oculus in the exact position it wanted when it set out late in 2014 to rebuild.  The company has new products on the market and a strong pipeline on schedule for commercialization.  They also have plenty of cash on hand to cover expenses related to R&D and adding, as indicated in the conference call, five more sales representatives to the staff “as fast as possible.”

The company is conceding the future revenue from Latin America with the sale, but it was low margin revenue that has been constantly challenged by the struggling peso.  The royalty agreement and interest from the cash collected will help offset the top-line difference.  More importantly, the value of the cash as to what it means to expedite market capture in the higher margin U.S. derm market business without diluting shareholders is intangible as it can return many multiples that will only be determined by Oculus continuing to deliver going forward.

The takeaway from the most recent conference call is that not only did management meet their guidance yet again, but actually greatly outperformed by putting the company in its best financial position ever and aligning for corporate breakeven sooner than most should have expected.

Non­Alcoholic Steatohepatitis (NASH), often called a “silent epidemic” that is slowly destroying the livers tens of millions of Americans, has attracted the attention of over a dozen pharmaceutical companies, including Gilead, Merck and Pfizer. The NASH treatment race started a couple of years ago and has recently heated back up on news that Allergan Plc is buying three companies focused on liver disease, including Tobira Therapeutics (TBRA) for a combined $2.4 billion. But, investors may also want to consider a few other companies that have a chance to be the best solution for treating NASH.

Endonovo Therapeutics, Inc. (ENDV) is a leading challenger to the Allergen acquisitions, and gives investors much more profit potential if it wins the race.

Endonovo is a developer of non­invasive electroceuticals targeting inflammatory conditions in vital organs. The company is initially concentrating on inflammatory conditions in the liver, such as acute liver injury and NASH. It brings a completely different approach to NASH than the rest of the competition that is developing drugs, in that it is developing a non­invasive approach that uses electrical stimulation to reduce inflammation in vital organs to treat the disease in its early stages. Endonovo’s device, which it has called Immunotronics, harnesses magnetically induced electrical field pathways in cells and organs to illicit an anti-inflammatory response. The company’s technology has already been shown to be a very potent anti-inflammatory device in a pharmaceutical “gold standard” model of inflammation. The company represents the most differentiated approach to the treatment of NASH and other inflammatory conditions in vital organs, and its biggest advantage is that it is a non­invasive device, so its regulatory pathway is much simpler than drugs.

Why NASH is So Hot Right Now

Non­Alcoholic Steatohepatitis (NASH) is liver inflammation and damage that is caused by a buildup of fat in the liver that is not caused by excessive alcohol consumption. It is a “silent” liver disease because most people with NASH feel well and are not aware that they have a liver problem. However, if left untreated, NASH can be severe and lead to cirrhosis, a condition where the liver is permanently damaged and can no longer function correctly.

This “silent epidemic” is being driven by the increasing number of Americans with obesity. NASH is estimated to affect 2 to 5 percent of Americans, and as much as a quarter of the American population has fat in their livers, a precursor condition to NASH called Non­Alcoholic Fatty Liver Disease (NAFLD).

There are currently no approved treatments for NASH. Therefore, it represents one of the last untapped multi­billion dollar therapeutic areas. The market could be worth $5 billion to $10 billion a year, according to a May estimate by RBC Capital Markets analyst Michael Yee.

Pharmaceutical companies are still studying how different components of the disease ­ inflammation, scarring and metabolic changes ­ interact and how different treatment mechanisms can be developed.

With so many companies entering the race for a NASH treatment, they’ll have to work very hard to distinguish themselves from the field.

Other Challengers

Besides the Gileads and Pfizers, there are a few other small biotechs aiming to treat NASH and other similar liver diseases.

Galectin Therapeutics, Inc. (GALT) is a microcap biotechnology company focused on targeting galectin proteins. Galectin’s NASH candidate, GR­MD­02, has quietly come toward that pivotal data readout in the first of its two major NASH clinical trials. GR­MD­02 has a Fast Track designation from the US Food and Drug Administration (FDA). The recent Allergan spending spree on NASH has resulted in a massive rally of Galectin’s shares on the potential of GR­MD­02 to treat fibrosis caused by NASH and the lead up to the report of topline results from its NASH­FX trial by the end of September. However, GALT reported topline results from its Phase 2a study, called NASH-FX, which failed both its primary and secondary endpoints.

Conatus Pharmaceuticals, Inc. (CNAT) is a biotech focused on the development of medicines to treat liver disease. Its lead candidate Emricasan (an orally­active pan­caspase protease inhibitor) is in a Phase 2b trial in patients with NASH fibrosis. Conatus has Fast Track designation from the US Food and Drug Administration (FDA) for the treatment of NASH cirrhosis. CNAT has multiple studies planned for different NASH populations.

Galmed Pharmaceuticals Ltd. (GLMD) is an Israel-­based clinical stage company that is developing a once­daily, oral therapy for the treatment of liver diseases and cholesterol gallstones utilizing its synthetic fatty­acid/bile­acid conjugate (FABAC), called Aramchol. Aramchol affects liver fat metabolism and has been shown in a Phase IIa clinical study to reduce liver fat content, as well as improve metabolic parameters associated with Nonalcoholic Steatohepatitis (NASH). The company is currently evaluating Aramchol in a Phase 2b study in patients with NASH, who are overweight or obese, and who are pre­diabetic or type­II diabetic. Aramchol also has FDA Fast Track designation status in the US.

The concept of electroceuticals, often called bioelectronics, dates back nearly three centuries to Italian physician, physicist and biologist Luigi Aloisio Galvani.  Even though we see applications today, including the basic example of pacemakers, the scientific community is only beginning to scratch the surface of the opportunity at hand to modulate the body’s neural superhighway to treat and prevent diseases and conditions.

In naming their new joint venture company Galvani Bioelectronics, GlaxoSmithKline (NYSE: GSK) and Google parent Alphabet’s (NASDAQ: GOOGL) life sciences unit paid tribute to the man widely credited for discovering animal electricity and pioneering bioelectromagnetics.  In the world’s most ambitious efforts in the electroceutical space to date, the two companies have agreed to spend $715 million across seven years to develop tiny, implantable devices aimed at modifying electrical nerve signals.  The investment speaks volumes to the potential therapeutic benefits of bioelectronic devices.

While several companies are addressing implantable devices, Endonovo Therapeutics (OTCQB: ENDV) is taking a different route in the electroceutical space.  The company is focused on non-invasive devices for multiple applications, namely to prevent vital organs from failing by controlling inflammation through its Immunotronics technology and growing more potent stem cells with its Cytotronics platform.

The groundwork for Immunotronics was discovered through the work of NASA during research to help astronauts maintain muscle mass and bone density while in outer space.  Endonovo has expanded upon the technology to direct it at treating liver disease and preventing liver failure, which are both diseases largely driven by inflammation in the liver.  Immunotronics differs from pulsed electromagnetic field therapies of the past by using Endonovo’s patented square waveform, which is delivered using extremely short electrical pulses to achieve deep tissue penetration and illicit a more potent cellular response.  In doing so, the pulses are able to promote an anti-inflammatory response as well as promote tissue repair.

Overseeing these efforts is Endonovo’s Chief Medical Officer Dr. Leonard Makowka, who, amongst numerous accomplishments, has served as the Chairman of the Department of Surgery and Director of Transplantation Services at Cedars Sinai Medical Center in Los Angeles and Executive Director of the Comprehensive Liver Disease Center at St. Vincent’s Medical Center in Los Angeles, where he created a multiple disciplinary approach to the treatment of liver disease.

According to CEO Alan Collier in the below video, the plan is to first clinically document the benefits of Immunotronics in liver conditions (Dr. Makowka’s expertise) and then move into other critical organs, such as the heart and lungs.

“Inflammation is the result of an out of control immune response due to an infection or injury.  In many cases, an implantable device is not even an option,” further explained Mr. Collier in a phone conversation.  “Our technology is not dependent on simply stimulating the vagus nerve, as many implantable devices do.  Using rapidly changing electromagnetic fields on the skin’s surface allows us to stimulate deeper tissues like organs to reduce inflammation and promote tissue repair without the need for any surgical procedure.  There is a great deal of value in that.”

Drug companies have spent billions on small molecules and biologics to address a multitude of inflammatory conditions with little to no avail. According to the Tufts Center for the Study of Drug Development (CSDD), the cost of developing a prescription drug that gains market approval is approximately $2.6 billion. This cost has increased 145%, correcting for inflation, over the estimate cost in 2003. That is why large pharmaceutical companies like GSK, who have seen declining earnings and drug failures, are rapidly jumping into the bioelectronic space. It is simply a matter of economics; it can take 10 years and over $2.5 billion to bring a drug to market. Therefore, the promise that bioelectronic medicines or electroceuticals bring, includes not only the possibility of reducing development times and costs, but also address currently untreatable diseases and reduce side effects of current drug treatments. The way that these devices work also allow companies to be able to slightly modify future devices to treat a variety of diseases, making 2nd and 3rd generation devices much easier and less costly to produce than the next big blockbuster drug.

Endonovo Therapeutics approach is different than most, it is developing non-implantable devices that deliver electrical stimulation non-invasively using Time-Vary Electromagnetic Fields (TVEMF) to stimulate cellular activity. Bioelectronic devices currently under development tend to center around the implantation of a vagus nerve stimulator, which appear to modulate organ function. Endonovo’s technology is much simpler to use and targets the cells and organs directly, rather than through the nerves. Its technology is also fundamentally different than implantable stimulators because the electrical fields generated by its technology are much lower in power than those used to stimulate nerves. The weak electrical fields used by Endonovo’s technology are used to enhance the natural regenerative properties of cells.

Endonovo’s technology already has shown tremendous promise in pre-clinical trials ranging from the reduction of acute inflammation to regenerating bone in animals. The Company is now targeting inflammation in vital organs and augmenting the regeneration of organs like the liver in the hope that one day transplants may be a thing of the past.

Endonovo CEO, Alan Collier, believes that his company has the ability to not only compete with big pharma and tech companies like GSK and Google, but also ultimately produce simpler, safer and more effective therapies.

Neurodegenerative diseases like Alzheimer’s disease affect an estimated 12 million people around the world. While heart disease and cancer rates have been declining, these kinds of diseases have become increasingly prevalent in today’s society.

Innovus Pharmaceuticals Inc. (OTCQB: INNV), an emerging commercial stage pharmaceutical company focused on over-the-counter medicine and consumer care products, recently announced the launch of its brain health supplement RecalMax™. Unlike many other OTC products, the supplement is supported by compelling clinical evidence and is backed by a proven robust marketing platform (Beyond Human Platform) that management believes will turn it into a $5M/year product.

In this article, we will take a closer look at RecalMax™ and the company’s plans to grow the product alongside its robust and expanding portfolio.

Clinically Proven Solution

Innovus Pharma’s RecalMax™ was tested in a four-month human clinical trial on 72 patients with low memory and learning. After taking one capsule twice a day for 16 weeks, patients reported a 115% increase in the recall of words and names, a 49.5% increase in maintaining thoughts when distracted, and a 35% increase in processing speed. The supplement was also well-tolerated with no serious adverse events reported.

“Having clinical data showing improvement in memory and learning differentiates RecalMax™ from the rest of the products on the market and gives it the credibility needed to make a strong entry into the market,” said Dr. Bassam Damaj, President and CEO of Innovus Pharma.

RecalMax™ is a patented oral low-dose formulation of Arginine and Citrulline with the natural absorption enhancer Bioperine®. L-Arginine is an amino acid that changes into nitric oxide in the body, which is a powerful neurotransmitter that helps blood vessels relax and improves circulation. These effects are enhanced by Bioperine® – a black pepper extract that enhances the bioavailability of nutrients by at least 30%, according to BioPerine®.

Significant End Markets

The global neurodegenerative diseases market is expected to grow from $8.8 billion in 2012 to $11 billion by 2018, according to Markets and Research, which represents a 1.8% compound annual growth rate. Parkinson’s and Alzheimer’s disease are the two most prevalent medical conditions falling into the category and are characterized by neurological problems affecting memory, learning, and nerve function – eventually leading to premature death.

The current market for Alzheimer’s treatments generates roughly $20 billion in revenue annually, according to Deutsche Bank. However, these treatments only treat the main symptoms of Alzheimer’s — memory loss, confusion, and cognitive problems — rather than the actual cause.

Aricept, developed by Eisai and Pfizer (NYSE: PFE), is the most popular of these treatments. Aricept is a cholinesterase inhibitor which prevents the breakdown of acetylcholine, a chemical messenger needed for learning and memory. By keeping acetylcholine levels elevated, Alzheimer’s symptoms can be held at bay for an average of six to twelve months in roughly half of the patients.

Aricept had peak sales of $2.4 billion in 2010, but have fallen dramatically over the years after its patent expiration. Today, generic Aricept is widely available from generics companies such as Actavis and Teva Pharmaceuticals.

Namenda, which was first synthesized by Eli Lilly & Co. (NYSE: LLY) in 1968, is another common treatment for Alzheimer’s disease. Namenda attempts to protect the brain’s nerve cells against glutamate, a chemical messenger which is released in excess amounts by cells damaged by Alzheimer’s disease and other neurological disorders. If glutamate binds to a patient’s brain cells, it allows calcium to freely enter the cells, causing cell degeneration.

Namenda is currently manufactured by Forest Pharmaceuticals, a subsidiary of Forest Laboratories. Last quarter, sales of Namenda rose 7.9% year-on-year to $397.5 million, accounting for 48% of Forest Laboratories’ top line until the patent expiration in 2015.

Innovus Pharma estimates that the immediate market for a product like RecalMax™ could be worth around $3 billion, since it helps treat some of the major endpoints associated with neurodegenerative diseases. Management believes that it can capture enough of the market to generate about $5 million in annual revenue by deploying the treatment across its well-established Beyond Human Platform and online marketing channels throughout the U.S. and other regions of the world.

Looking Ahead

Innovus Pharma trades with a market capitalization of just $26 million with sales of about $1 million during the second quarter of this year. With RecalMax™ expected to generate upwards of $5 million in annual sales, the product launch could significantly increase the company’s revenue and its subsequent market capitalization. Investors may want to keep a close eye on the stock given this potential to improve shareholder value alone.

In addition to RecalMax™, the company has a robust pipeline of commercial-stage and up-and-coming products to watch. The most notable is its ANDA application with the FDA for the approval of FlutiCare™; a decision is expected in the very near future. FlutiCare™ is a prescription strength OTC treatment for non-allergic rhinitis and would compete with blockbuster drugs like Glaxosmithkline plc’s (NYSE: GSK) Flonase.

For more information, download our free Company Analysis or visit the company’s website at www.innovuspharma.com.

Innovus Pharmaceuticals Inc. (OTCQB: INNV) is an emerging commercial stage pharmaceutical company that delivers safe, innovative, and effective over-the-counter medicine and consumer care products to improve men and women’s health and respiratory diseases.

In this article, we speak with recently appointed Chief Financial Officer Robert Hoffman about his new role at the company, growth plans, revenues, and what investors should watch for over the coming quarters.

Can you discuss your background and your new role at Innovus Pharma?

I am very excited to be joining the Innovus Pharma team. By way of background, I have nearly 20 years of biotech experience. I was part of the startup management team at Arena Pharmaceuticals in 1997, took Arena public in 2000, and in total was involved in fund raising in excess of $1 billion through 2015. In addition, I was involved in all of the acquisition transactions Arena made during my 18 years there. I sit on several public company boards, giving me a unique perspective on other biotech companies, market trends, and how Innovus is viewed from the investment community.

I am active in the financial community. Several years ago I was the President of the local chapter of Financial Executives International or FEI. I am on the steering committee of the Association of Bioscience Financial Officers and have served on the Small Business Advisory Committee advising the Financial Accounting Standards Board (FASB) on various rulemaking activities.

In my new role as EVP and CFO of Innovus, I am looking forward to overseeing various aspects of the business, including investor relations, finance and accounting, human resources, and information technology. In particular, I will be focusing with CEO Dr. Bassam Damaj on continuing our revenue growth organically through expanding the sales of our current products in the US, finding additional partners to launch our products outside the US, and continue our quest for additional revenue generation products to in-license or acquire. We are launching several promising products – which makes it exciting times for me to join the Innovus Pharma management team.

What attracted you to Innovus and where do you see the company heading over the next year or two?

Prior to joining Innovus in the capacity as CFO, I was a member of the Innovus Pharma Business Advisory Board. In particular, I have an excellent working relationship with Dr. Damaj.

Dr. Damaj has done an excellent job in first funding the Company from his own money. As you know, and the company publicly filed, he gave Innovus Pharma a $2.5M line of credit which allowed the Company to acquire revenue generating products, move into a commercial phase, and broaden its product offerings, giving rise to a significant increase in revenues. Dr. Damaj then led the Company in raising close to $5M through institutional investors and others to increase the commercialization efforts of the Company and to improve returns to the Company’s shareholders by moving the company into a positive cash flow position. Dr. Damaj’s background is very impressive and he is known for his ability to grow companies and generate revenues.

I am looking forward to several new product launches over the next few years, in particular FlutiCare™ in the respiratory market upon a potential FDA approval.

Innovus has announced publicly that it has plans to Up-List in the near future. How do you plan to get there and what kind of impact could that have on the Company?

I am very much looking forward to an Up-Listing transaction. Leading up to such a transaction it is important to continue to execute on the business plan of increasing product offerings in men’s and women’s health as well as in the respiratory field. Communication with the investment community is critical during this time period. I am a big believer in clearly communicating future milestones of the Company and executing on those milestones.

An up-listing transaction would most certainly broaden our appeal in the investment community as well as access to capital in the future.

I do have to be clear that we are being very cautious about an up-listing with our current share price. Innovus has a lot of potential and we are confident that the market will continue to appreciate the Company and its assets as we hope to create value by executing on our milestones.

What are some of your other goals at Innovus Pharma? What milestones should investors look for over the next year or two?

We are very focused on generating revenues and moving to profitability. This is a goal that I share with Dr. Damaj and I believe it is the most important goal that a Company can have to make it independent of the need to continuously raise money to survive.

Our Company goals are very clear:

1. Our first goal is to continue our revenue growth and meet the $5M projected revenue for this year 2016.
2. Projecting to be profitable in 2017 with annual revenues of $15M in that year
3. Expand our product offerings, markets where they can be commercialized and continue our organic growth
4. Up-list the Company to a national exchange once the share price appreciation makes sense.

For more information about Innovus Pharma, visit the company’s website at www.innovuspharma.com. 

Independent Analyst Suggest Price Target 150% Higher Than Current Levels Based on Strong Future Growth and Profitability

Innovus Pharmaceuticals Inc. (OTC: INNV) reported a robust second quarter with $1 million in revenue and positive operational cash flow of $256,000. In addition to exceeding Q2 estimates, the company issued revenue guidance of $5 million in FY16 that was well ahead of expectations for the year. SeeThruEquity analysts responded to the strong earnings and outlook by raising their price target to $1.00 per share – a 147% premium to the current market price.

In this article, we will take a closer look at the company’s robust second quarter performance, its strong outlook for the fully year, and SeeThruEquity’s expectation for a 147% jump.

Robust Q2 Performance

Innovus Pharma reported second quarter revenue that rose more than 400% to $1 million compared to $183,000 during the year ago period. Strong revenue from its Beyond Human acquisition was the primary driver behind the top-line growth, while Vesele®’s launch on the platform propelled its annual revenue to a $900,000 run rate. Management plans to launch its other product lines on the Beyond Human platform to add $3 to $5 million in annual revenue.

“We have exceeded our commercial expectations, and with the projected launch of Sensum+®, RecalMax™, and Xyralid® in the second half of 2016, we believe that revenues will continue to increase through the balance of 2016 and into 2017 and exceed our projections,” said Innovus Pharmaceuticals President & CEO Dr. Bassam Damaj.

The company also became cash flow positive well-ahead of its original timeline thanks to gross margins that improved 10% to 74% year over year. While the company reported a $4 million net loss on its income statement, this was largely attributable to non-cash changes in the fair value of derivative liabilities related to certain warrants and conversion features in its convertible debt and other financial instruments rather than its core business.

“Becoming operationally cash flow positive from the second quarter, and ahead of the timeline projected, is a major financial achievement for the company and a big step towards our projected profitability in 2017,” added Dr. Damaj.

Strong Outlook for FY16

Innovus Pharma surprised many investors by announcing that it intends to reach $5 million in sales for the full year, which is well ahead of its previous estimate of $3 million in revenue. These results are likely to be driven by the onboarding of Sensum+®, EjectDelay®, and other products to the Beyond Human platform, which reaches over 1,000 newspapers and magazines through an extensive marketing distribution channel.

The projections presumably do not include an FDA ANDA approval of FlutiCare™, which could easily become the company’s top-selling product. The nasal allergy spray has already generated millions of dollars as a leading prescription medication, which means that an over-the-counter approval could position it next to blockbuster products like GlaxoSmithKline’s (NYSE: GSK) Flonase – a drug that has surpassed $1 billion in total sales since its introduction.

The company raised $1.5 million in July and about $200,000 from the exercise of warrants, while registered warrants could provide another $1.2 million in cash. These financing sources should provide the company with ample funds to finance its growth as it targets $5 million in revenue for the year and a breakeven point next year.

Analyst Sees 147% Upside

SeeThruEquity raised its price target for Innovus Pharma to $1.00 per share on August 15 in a research update, citing the company’s recent results and guidance.

According to the analyst report:

In light of results and guidance that were ahead of our expectations we are raising our target for Innovus to $1.00. We see Innovus as a high-risk / high-reward investment opportunity in the OTC pharmaceuticals space with a differentiated business model focused on men and women’s health and vitality. If achieved, the price target of $1.00 reflects potential upside of 143.9% from the recent price of $0.41.

The analyst firm projects that revenues will grow from $5 million in FY16 to $14.7 million by FY17, while net income will swing from a $3.5 million loss in FY16 to a $1.6 million profit by FY17. When it comes to valuation, the firm anticipates that the stock will trade with an EV/EBITDA multiple of 14.2x and an EV/Revenue multiple of 2.2x by FY17. These estimates also reflect gross margins of just 64% by FY17 despite Q2 margins of more than 70%.

Investors can download the full research report on SeeThruEquity’s website: http://www.seethruequity.com/#!innv/c12jb.

Looking Ahead

Innovus Pharma reported a robust second quarter that exceeded analyst expectations by a wide margin. In response, SeeThruEquity analysts raised their price target to $1.00 per share, which represents a significant 147% premium to the current market price. Investors may want to take a closer look at the company as it continues to expand its organic revenue and prepares for a potential FDA ANDA approval of its FlutiCare™ product.

For more information, visit the company’s website at www.innovuspharma.com.

Innovus Pharmaceuticals, Inc., (“Innovus Pharma”) ( OTCQB : INNV )www.innovuspharma.com announced today it has re-appointed PT Laras Bumi Resources (“LB Resources”) as its agent for the distribution of its product Zestra® to increase Female Sexual Arousal and Desire and Satisfaction in select Asian countries. Based in Indonesia (“LB Resources”) has extensive distribution in Japan, China, Indonesia and South Korea. LB Resources projects an initial ordering annual volume close to 150,000 units a year.

Prior to its acquisition by Innovus Pharma, Semprae Labs shipped over 1 million units of Zestra® to Asia.

Since Zestra® is already registered as a cosmetic in China and South Korea and is well known, the Company expects to start commercial shipments as early as September 2016.

 “This partnership is an important one for the Company as it allows us to resume sales of Zestra® to multiple Asian countries where the product is already registered. Our goal is to quickly get back to the one million units of sales a year previously achieved by the product,” said Dr. Bassam Damaj, President& CEO of Innovus.

About Zestra® and FSI/AD
Zestra® is a patented blend of natural oils clinically-proven in double-blind placebo-controlled clinical trials in 276 women to increase in a statistical significant manner the arousal, desire and sexual satisfaction in FSI/AD women. Zestra® is the first NHP product to receive approval for the indication of FSI/AD in Canada as an NHP. To date, the Company believes that no product has been approved to treat FSI/AD, a persistent or recurring inability to attain or maintain adequate sexual excitement until the completion of a sexual activity. The diagnosis can also refer to an inadequate lubrication-swelling response normally present during arousal and sexual activity causing personal distress. Published papers on the FSI/AD market size estimate it to be equal or larger than the market for erectile dysfunction in males, and possibly larger. Zestra® is currently available in the United States, Canada and Morocco. For more information visit www.zestra.com

About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging leader in OTC and consumer products for men’s and women’s health and vitality. The Company generates revenues from its lead products Zestra® for female arousal and EjectDelay® for premature ejaculation and has a total of five marketed products in this space, including Sensum+® for the indication of reduced penile sensitivity, (for sales outside the U.S. only), Zestra Glide®, Vesele® for promoting sexual and cognitive health, Androferti® (in the US and Canada) to support overall male reproductive health and sperm quality and hopefully, eventually from FlutiCare™ OTC for Allergic Rhinitis for which an ANDA has been submitted to the U.S. Food and Drug Administration.

For more information, go to www.innovuspharma.com,www.zestra.com;www.ejectdelay.com; www.myvesele.com;www.sensumplus.com;www.myandroferti.com;www.beyondhumantestosterone.com;www.getbeyondhuman.com;www.trybeyondhuman.com; www.recalmax.com.

About PT Laras Bumi Resources.
Established in 1987 and based in Indonesia, PT Laras Bumi Resources Food & Health Products Division has developed extensive distribution, compliance and regulatory expertise in Asia including extensive affiliations in Greater China, Korea, Japan, Russia, Asiana Indonesia and Singapore.

For more information please visit: www.lbresources.com

Innovus Pharma’s Forward-Looking Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, receiving patent protection for any of its products, receiving approval or to be compliant with the requirements of any relevant regulatory authority, to successfully commercialize its products and to achieve its other development, commercialization, meeting its sales projections, financial and staffing objectives. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company’s most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC’s website or without charge from the Company.