Category: Health

Baudax Bio (BXRX) – Curing a Deficiency

Posted on by cpatches


Wednesday, September 21, 2022

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Issuing Series B Preferred Stock. In an 8-K filing dated September 19, 2022, Baudax Bio declared a dividend of one one-thousandth (1/1,000th) of a share of Series B Preferred Stock, par value $0.01 per whole share, for each share of the Company’s Common Stock to shareholders of record at 5pm ET September 29, 2022.

Voting Rights to Cure the Deficiency.  Each share of Series B Preferred Stock will entitle the holder to 1,000,000 votes per whole share (or 1,000 votes for each 1/1,000th share).  Outstanding shares of Series B Preferred will vote together with the outstanding shares of Common Stock as a single class to exclusively vote on matters related to reclassify shares of Common Stock via a reverse stock split. The Company is intending to cure its Nasdaq minimum closing price deficiency. The preferred shares will not be entitled to vote on any other matter, nor are they convertible or exchangeable for another class of shares.  


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Ayala Pharmaceuticals (AYLA) – Lowering AYLA To Market Perform

Posted on by cpatches


Tuesday, September 20, 2022

Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Lowering AYLA To Market Perform.  We are lowering our rating on Ayala Pharmaceuticals to Market Perform.  Our Investment Thesis was based on successful development of AL101 and AL102 in several indications. However, the clinical trials have not advanced as we had anticipated while the risk to the stock has increased.

Clinical Trials.  AL101 and AL102 were designed to block activation of the NOTCH pathway and its effects on cancer growth.  We viewed the Phase 2 for AL101 in Adenoid Cystic Carcinoma (ACC) and the Phase 2/3 for AL102 in desmoid tumors as both Orphan indications as well as proof-of-concept that could lead to combination regimens in cancers with NOTCH mutations that are aggressive and difficult to treat.  The Phase 2 TENACITY trial testing AL101 in triple-negative breast cancer (TNBC) was the first indication that could open large patient populations for AL101/AL102.  However, this indication, as well as the collaboration with Novartis for multiple myeloma, has been discontinued.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Avivagen Inc. (VIVXF) – Slower Quarter but Increasing Activity

Posted on by cpatches


Tuesday, September 20, 2022

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Results for Q3. Total revenue for the quarter was $48,606 (all figures are in Canadian $), down from $505,886 the previous year and below our estimate of $100,000. The decrease was due to lower sales in the OxC-Beta product. Net loss was at $1.9 million versus a loss of $1.5 million in the prior year and our loss estimate of $1.54 million. The increased net loss was due to higher salaries expense and a decrease in government grants.

Sales Update for OxC-Beta. Avivagen sold a total of 350 kilograms of OxC-Beta during the third quarter, down from 925 kg in Q2 and 2,550 kg in Q1. Thailand ordered 250 kg during the quarter while Taiwan ordered 100 kg. The average price per kilogram in the quarter was $103.10 versus $102.27 in the second quarter.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Ocugen Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on OCGN

MALVERN, Pa., Sept. 16, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the Compensation Committee of the Board of Directors of Ocugen approved the grant of stock options to purchase an aggregate of 148,800 shares of its common stock and restricted stock units (RSUs) covering an aggregate of 40,092 shares of common stock to five newly hired team members. The stock options and RSUs were granted as of September 16, 2022, as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

The stock options have a ten-year term and have an exercise price of $2.17 per share, which was the closing price of Ocugen’s common stock on the grant date. The stock options and RSUs vest in equal annual installments over a three-year period starting on the one-year anniversary of the grant date, subject to the applicable new employee’s continued service with Ocugen through the applicable vesting dates. The stock options and RSUs were granted outside of Ocugen’s 2019 Equity Incentive Plan.

About Ocugen, Inc.

Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:

Tiffany Hamilton
Head of Communications
IR@ocugen.com

MustGrow Biologics Corp. (MGROF) – A Progress Update

Posted on by cpatches


Friday, September 16, 2022

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

A Look-in on Programs. Yesterday, MustGrow announced the update on the Company’s biological programs with various partners Sumitomo, Bayer, Janssen PMP, and NexusBioAg. The update includes the soil biofumigation, postharvest food preservation, and bioherbicide of the Company’s mustard-derived technology.

Soil Biofumigation. Data regarding efficacy continue to remain positive, as the Company recently extended the program with Sumitomo that we highlighted in August. Sumitomo is working with MustGrow and the EPA in the registration approval process in the U.S. along with registration in Mexico. In Chile, the country approved an Experimental Use permit and registration work has commenced. Bayer has shown positive results in laboratory and greenhouse studies, and has new trials underway and further studies planned for Europe, Asia, and Africa.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

With New Health Research Mandate Billions To Be Made Available

Posted on by cpatches
Image: Public Domain (Pexels)

ARPA-H: High-Risk, High-Reward Health Research is the Mandate of New, Billion-Dollar US Agency

A new multibillion-dollar federal agency was created with a goal of supporting “the next generation of moonshots for health” in science, logistics, diversity and equality. And the agency now has it’s first leader, as President Joe Biden announced Renee Wegrzyn as director of the Advanced Research Projects Agency for Health, or ARPA-H, on Sept. 12, 2022.

Since the announcement of the intention to establish ARPA-H two years ago, this new agency has sparked interest and questions within both academia and industry.

This article was republished  with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Tong Sun, Assistant Dean of Translational Health Sciences, University of Washington.

I have been a director of innovation-driven health institutes for decades and have worked with many of the government agencies that fund science. I and many of my colleagues hope ARPA-H will become an agency that can quickly turn scientific discoveries into real-world advances to detect, prevent and treat diseases like cancer, diabetes and Alzheimer’s. But questions still remain surrounding how it will work and what makes it different from other government-funded agencies such as the National Institutes of Health and the National Science Foundation.

What is ARPA-H?

ARPA-H is the newest entity established within the National Institutes of Health. ARPA-H was explicitly set up as an independent agency within NIH, in theory allowing it to benefit from the NIH’s vast scientific and administrative expertise and resources while still being nimble and forward-thinking.

ARPA-H was inspired by and modeled after the Defense Advanced Research Projects Agency, or DARPA, to rapidly develop cutting-edge technologies. DARPA is small compared to other federal research and development agencies, but has long been hugely successful. It played a critical role in spawning many technologies ranging from the internet to GPS, and even funded Moderna to develop mRNA vaccine technology in 2013.

ARPA-H is not the only DARPA spinoff. In 2006, the federal government created the Intelligence Advanced Research Projects Activity to tackle difficult challenges in the intelligence community, and in 2009, the Advanced Research Projects Agency for Energy was launched. Though its budget is small compared to the Department of Energy, ARPA-E has been incredibly effective in funding ambitious research into fighting climate change. By funding ambitious mid- and long-term projects, IARPA, ARPA-E and now ARPA-H are meant to operate in between slow, government-funded basic research and short-term, profit-driven private sector venture capital.

ARPA-H is modeled after the Defense Advanced Research Projects Agency, which played a key role in developing many modern technologies, including personal computers. Tim Colegrove (Wikimedia Commons)

How Will the Agency Function?

Biden wants ARPA-H to replicate the success of DARPA, but in the health care realm, by providing “leadership for high-risk, high-reward biomedical and health research to speed application and implementation of health breakthroughs equitably.”

Established federal agencies like the NIH and the National Science Foundation prefer to fund more basic research and less risky projects compared to the high-risk, high-reward, applied science approach of DARPA. If ARPA-H wants to achieve the success of its predecessor, it will need to operate differently from NIH and NSF.

DARPA employs about 100 program managers who are “borrowed” from academia or industry for three to five years. These managers travel across the nation to meet with scientists and experts in different fields in order to generate ideas and start projects. These managers make funding decisions and work closely with their funded teams to overcome problems, but will cut funding if teams cannot deliver promised milestones on time. Many DARPA projects don’t produce spectacular successes, yet they pushed the boundaries of science and technology.

Many years ago, I had the privilege of working with a DARPA program manager alongside numerous experts in various scientific and medical fields. After several months of meetings, the program manager came up with the idea to develop “fracture putty” – a puttylike material that could be applied to the shattered bones of a wounded soldier in the battlefield. The material would support weight, prevent infection, expedite healing and bone regeneration and eventually dissolve away. The program launched in 2008, and our team of chemists, nanomaterials experts, bioengineers, mathematical modelers and surgeons was one of the funded teams in this program.

President Joe Biden appointed Renee Wegrzyn, a former DARPA project manager and biotech industry expert, to lead ARPA-H. Image: Renee Wegrzyn (@rwegrzyn)

Who is the New Director?

Wegrzyn holds a Ph.D. in molecular biology and bioengineering from Georgia Tech. She is currently a vice president of business development at Ginkgo Bioworks, a U.S. biotech company. Wegrzyn spent four and half years as a program manager in DARPA’s Biological Technologies Office, where she managed projects that focused on using genetic engineering and gene editing for biosecurity and public health. She also worked for another DARPA-inspired agency, Intelligence Advanced Research Projects Activity.

At this moment, we don’t know yet the exact plan and progress in hiring APPA-H program managers and where APAR-H’s headquarters will be located. Several cities have expressed interest.

What Should People Look for as ARPA-H Gets Started?

DARPA is driven by talented, ambitious and risk-taking program managers. They are the ones who generate ideas and turn lofty goals into executable projects. It will be interesting to see how many and what kind of program managers ARPA-H hires in its early days, as these decisions will give an indication of which areas within health care the agency will be prioritizing.

I’ll also be watching to see how well ARPA-H and its program managers work within the NIH, which has an unbelievable depth of resources and expertise in all health care related fields that ARPA-H can tap into. But the NIH has very different funding mechanisms and culture from DARPA.

The final question is money. Biden wants US$6.5 billion in funding for ARPA-H, and he’s only gotten $1 billion from Congress so far. This is its first, biggest challenge. Finding political unity for funding may have to be this new agency’s first big breakthrough if it is to reach its goals.

Release – Tonix Pharmaceuticals Announces Data Presentations Involving TNX-1500 (Fc-Modified Anti-CD40L mAb) for the Prevention of Rejection in Allograft and Xenograft Transplantation in Animal Models at the International Congress of The Transplantation Society (TTS 2022)

Posted on by aweinsoff@channelchek.com

Research, News, and Market Dat on TNXP

September 15, 2022 7:00am EDT

TNX-1500 Treatment Prevents Organ Rejection and Preserves Function for Both Allograft and Xenograft Transplants in Animal Studies

CHATHAM, N.J., Sept. 15, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced data from three oral presentations by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital Center at the 29th International Congress of The Transplantation Society (TTS 2022) held September 10-14, 2022 in Buenos Aires, Argentina. The data involve studies of Tonix’s TNX-1500 (Fc modified anti-CD40L monoclonal antibody) product candidate in development for the prevention of organ transplant rejection. The molecular target of TNX-1500 is CD40-ligand (CD40L), which is also known as CD154. Copies of the presentations are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

The presentations titled, “Long-term rejection-free renal allograft survival with Fc-modified anti-CD154 antibody monotherapy in nonhuman primates,” and “Monotherapy with TNX-1500, a Fc-modified anti-CD154mAb, prolongs cardiac allograft survival in cynomolgus monkeys,” include data demonstrating that TNX-1500 treatment showed activity in preventing organ rejection and was well tolerated in non-human primates. Blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity in non-human primate cardiac and kidney allograft models without clinical thrombosis.

The presentation titled, “Long-term (>1 year) rejection-free survival of kidney xenografts with triple xenoantigen knockout and multiple human transgenes in nonhuman primates,” includes data demonstrating that TNX-1500 treatment showed activity in preventing xenograft kidney rejection and was well tolerated in non-human primates. Xenografts are transplanted organs from donors of a different species from the recipient, and in this study, the xenografts originated from genetically engineered pigs. Blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic xenoimmunity in non-human primate kidney xenograft models without clinical thrombosis.

“There remains a significant need for new treatments with improved activity and tolerability to prevent organ transplant rejection,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “To date, there has not been a humanized anti-CD40L antibody that can effectively prevent transplant rejections with an acceptable level of tolerability. TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. The animal studies found that TNX-1500 retains activity to prevent rejection and preserve graft function. We believe TNX-1500 has the potential for treating and preventing organ transplant rejection in both allograft and xenograft transplants. Tonix expects to initiate a Phase 1 trial of TNX-1500 in the first half of 2023. Preventing transplant rejection is the first indication we are pursuing, but based on results of anti-CD40L in numerous animal models, we believe that TNX-1500 has the potential for treating a number of autoimmune conditions.”

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the first half of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform. A Phase 1 study of the COVID-19 vaccine is expected to be initiated in the second half of 2023.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released September 15, 2022

Release – MustGrow and Global Partners Drive Biological Programs Forward

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on MGROF

  • Soil biofumigation platform continues to show promising results across multiple continents.
  • Postharvest activities in potatoes, fruits and vegetables have demonstrated initial efficacy and work is now focused on application, timing, dose rates and residues.
  • Bioherbicide optimization and formulation work advances.

Saskatoon, Saskatchewan–(Newsfile Corp. – September 15, 2022) – MustGrow Biologics Corp. (CSE: MGRO) (OTCQB: MGROF) (FSE: 0C0) (the “Company” or “MustGrow“), and its global agriculture partners continue to drive MustGrow’s organic mustard-derived crop protection and food preservation technology forward through field trials, development work and regulatory approval strategies in key global agricultural regions. Publicly-disclosed programs include:

  • Sumitomo Corporation

Exclusive evaluation agreement in the Americas for preplant soil fumigation, bioherbicide, postharvest and food preservation for potatoes and bananas. Sumitomo Corporation is funding and driving all field development, including toxicology, safety, efficacy, and regulatory work necessary for commercialization. (Press release link)

  • Bayer

Exclusive evaluation agreement in Europe, Asia Pacific, Middle East and Africa for preplant soil fumigation, bioherbicide applications and postharvest food preservation of potatoes including sprout inhibition. The first year of the evaluation is focused on the pre-plant soil fumigant application. Bayer is funding and driving all laboratory, field, regulatory, and market assessments in the target regions. (Press release link)

  • Janssen PMP, a division of Johnson & Johnson-owned Janssen Pharmaceutica NV

Global exclusive evaluation agreement for postharvest storage preservation of fruits and vegetables, excluding grains, potatoes, bananas and shipping container fumigation. Janssen PMP is funding and driving all application testing and development work. (Press release link)

  • NexusBioAg, a division of Univar Solutions

Exclusive marketing and distribution agreement in Canada for canola (clubroot disease) and pulse crops (aphanomyces disease). NexusBioAg is funding and driving all field development and regulatory work necessary for commercialization. (Press release link)

———

GLOBAL PROGRAM ADVANCEMENTS:

Soil Biofumigation
Sumitomo Corporation has continued to generate data across multiple crops, evaluating application timing, methods, and dose rates. Efficacy data generated across multiple countries and programs remains positive and has already resulted in new country expansions and program extension. MustGrow and Sumitomo Corporation are continually assessing market opportunities for further regional and application expansions. Utilizing MustGrow’s platform technology, Sumitomo Corporation currently has field trials and regulatory development work ongoing in the US, Mexico, and Chile.

In the US, EPA product registration work continues to advance, with Sumitomo Corporation playing a pivotal role in the registration approval process. In addition, Mexico registration work is progressing forward, as there have now been two consecutive years of successful field trials with Sumitomo Corporation. Mexico is a key global agriculture region both in size and strategic location. In Chile, registration work has commenced with the country approving an Experimental Use Permit to Sumitomo Corporation and MustGrow for field testing and registration activities.

Bayer’s initial laboratory and greenhouse studies utilizing MustGrow’s mustard-derived technology have been promising. Building on these positive results, Bayer and MustGrow have new trials underway and further studies planned across Europe, Asia and Africa. Bayer is evaluating registration pathways for multiple regions.

Building on their 2021 field trial program for treatment of canola (clubroot disease) and pulse crops (aphanomyces disease), NexusBioAg and MustGrow signed an Exclusive Marketing and Distribution Agreement in Canada. NexusBioAg intends to trial MustGrow’s technology in its 2023 BioAg Advantage program (“BAT“), which are wide-scale field trials conducted at the farmer level. NexusBioAg leverages its BAT program to introduce new and exciting potential ‘portfolio’ products to large Canadian farmers.

Postharvest Food Preservation
Harnessing MustGrow’s mustard-derived biological agent as a postharvest fruit and vegetable application, Janssen PMP has demonstrated initial success in decay, fungal, and bacterial disease efficacy. Advancing to the next stage, Janssen PMP’s testing program will focus on phytotoxicity, residues, application rates, application methods and dose timing. As food preservation is a critical global issue, reducing postharvest fruit and vegetable losses could substantially increase worldwide food availability.

MustGrow had previously tested its organic mustard-based technology and outperformed leading synthetic chemical standards for treatment of stored potatoes for both Fusarium dry rot disease and sprouting. No disease/sprouting combination solutions currently exist in the marketplace, making MustGrow’s application unique in addressing both issues simultaneously. Leading sprout inhibiter chlorpropham (CIPC) had been banned by the European Union as of Oct. 8, 2020. Sumitomo Corporation is advancing this program in the US with trials and data review ongoing.

Bioherbicide
MustGrow’s bioherbicide program is now focused on extraction optimization and formulation work. Perfomance and efficacy knowledge utilizing the mustard-derived Thiocyanate molecule, both internally and externally, has demonstrated potential impact as both a stand alone and combination herbicide in multiple markets. MustGrow is focused on production parameters, improving formulations for application flexibility, and the potential to combine MustGrow’s bioherbicide with leading chemicals.

———

About MustGrow
MustGrow is an agriculture biotech company developing organic biopesticides and bioherbicides by harnessing the natural defense mechanism of the mustard plant to protect the global food supply from diseases, insect pests, and weeds. MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Over 100 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection. Pending regulatory approval, MustGrow’s patented liquid products could be applied through injection, standard drip or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation. MustGrow has approximately 49.2 million basic common shares issued and outstanding and 55.6 million shares fully diluted. For further details, please visit www.mustgrow.ca.

ON BEHALF OF THE BOARD

“Corey Giasson”

Director & CEO
Phone: +1-306-668-2652
info@mustgrow.ca

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: (i) potential product approvals; (ii) anticipated actions by partners to drive field development work including dose rates, application frequency, application methods, and the regulatory work necessary for commercialization; (iii) expected product efficacy of MustGrow’s mustard-based technologies; and (iv) expected outcomes from collaborations with commercial partners.

Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) the preferences and choices of agricultural regulators with respect to product approval timelines; (ii) the ability of MustGrow’s partners to meet obligations under their respective agreements; and (iii) other risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2021 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the CSE nor its Regulation Services Provider (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

© 2022 MustGrow Biologics Corp. All rights reserved.

Release – Schwazze Signs Definitive Documents To Acquire Certain Assets Of Lightshade Labs LLC

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on SHWZ

Continues to Go Deep, Adding to Retail Footprint in Colorado

DENVER, CO – September 14, 2022 – Schwazze, (OTCQX:SHWZ NEO:SHWZ) (“Schwazze” or the “Company”), announced that it has signed definitive documents to acquire certain assets of Lightshade Labs LLC (“Lightshade”). The proposed transaction includes the adult use Lightshade dispensaries located at 503 Havana St. in Aurora, as well as 2215 E. Mississippi Ave. in Denver’s vibrant Washington Park neighborhood. This acquisition continues Schwazze’s aggressive expansion in Colorado and upon close will bring the Company’s total number of Colorado dispensaries to 25.

The consideration for the proposed acquisition is US$2.75 million and will be paid as all cash. The acquisition is expected to close in the first quarter of 2023 after Colorado Marijuana Enforcement Division and local licensing approval.

“Schwazze is excited to add to our retail footprint in the greater Denver area, providing two additional retail locations to our existing 23 throughout Colorado. We look forward to extending our exceptional customer service and wide product selection to both new and existing customers in these new locations.” said Collin Lodge, Division President of Colorado.

Since April 2020, Schwazze has acquired or announced the planned acquisition of 35 cannabis dispensaries as well as seven cultivation facilities and two manufacturing assets in Colorado and New Mexico. In May 2021, Schwazze announced its BioSciences division and in August 2021 it commenced home delivery services in Colorado.

About Schwazze

Schwazze (OTCQX: SHWZ NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high- performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices. Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and outside the state, (vii) our ability to consummate the acquisition described in this press release or to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses, including the acquisition described in this press release, and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, (x) the timing and extent of governmental stimulus programs, and (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.
 

Investors
Joanne Jobin
Investor Relations
Joanne.jobin@schwazze.com
647 964 0292		Media
Julie Suntrup, Schwazze
Vice President | Marketing & Merchandising
julie.suntrup@schwazze.com
303 371 0387

Release – Ocugen Announces Publication of a Comprehensive Review of BBV152 in Frontiers in Immunology

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on OCGN

September 14, 2022

  • Data include the persistence of immune responses and protection against variants of concern, especially Delta and Omicron
  • Ocugen has North American commercialization rights for BBV152, commercialized as COVAXIN™

MALVERN, Pa., Sept. 14, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the publication “A comprehensive review of BBV152 vaccine development, effectiveness, safety, challenges, and prospects” appeared in Frontiers in Immunology. BBV152, commercialized as COVAXIN™, is developed and manufactured by Ocugen’s partner Bharat Biotech, a global leader in vaccine innovation based in Hyderabad, India. BBV152 is currently authorized by the World Health Organization, authorized under Emergency Use Authorization in 28 countries, and accepted as a COVID-19 vaccine to travel into over 85 countries. It is under clinical investigation by Ocugen in the United States for use in adults aged 18 years and older.

This review by Dotiwala and Upadhyay provides a detailed analysis of the immunogenicity, safety, and efficacy of BBV152—a whole virus inactivated vaccine and an important tool in the fight to control the COVID-19 pandemic. Additionally, BBV152 has a broader impact on public health, as it induces high neutralization efficacy against different SARS-CoV-2 variants of concern.

“Unfortunately, the COVID-19 pandemic is not yet over, despite the introduction of effective vaccines and a greater understanding of COVID-19 pathogenesis and transmission dynamics,” said David Fajgenbaum, MD, MBA, MSc, Assistant Professor of Medicine, Translational Medicine & Human Genetics, University of Pennsylvania, and Ocugen Vaccine Scientific Advisory Board member. “This study demonstrates durability through immune memory and a broader immune response with BBV152 and provides further evidence that additional vaccine options—including those built on a traditional vaccine platform—are needed.”

Findings include:

  • 77.8% and 93.4% protection from symptomatic COVID-19 disease and severe symptomatic COVID-19 disease respectively.
  • Studies in pediatric populations show superior immunogenicity (geometric mean titer ratio of 1.76 compared to an adult) with a seroconversion rate of >95%.
  • Reactogenicity and safety profiles were comparable across all pediatric age groups between 2-18 yrs.

The study concludes that BBV152 is a suitable alternative to mRNA vaccines.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. 
Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:

Tiffany Hamilton
Head of Communications
IR@ocugen.com

Onconova Therapeutics (ONTX) – Rigosertib Phase 1/2a Trial Data Reported At ESMO

Posted on by cpatches


Tuesday, September 13, 2022

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China. Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Data Shows Efficacy After Treatment Failures.  Onconova presented positive interim data from its Phase 1/2a trial testing rigosertib at the European Society for Medical Oncology (ESMO).  The Investigator-sponsored trial tested the combination of rigosertib with nivolumab, an anti-PD1 checkpoint inhibitor, in non-small cell lung cancer patients that had progressive non-small cell lung cancer (NSCLC) following treatment with checkpoint inhibitor therapies.

Patients Showed Both Complete and Partial Responses.  The interim data reported was for 14 out of 19 patients enrolled in the study.  Four of the 14 (29%) showed disease control responses, including 1 complete response, 2 partial responses, and 1 stable disease.  Mean survival for these responders was 6.75 months, compared with 1-2 months for the non-responders.  Each responding patient had a different mutation in the KRAS gene, showing activity against multiple variants.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Ayala Pharmaceuticals (AYLA) – Phase 2/3 RINGSIDE Data Presented, Dose Selected For Next Stage

Posted on by cpatches


Tuesday, September 13, 2022

Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

First AL012 RINGSIDE Data Presented At ESMO.  Ayala presented first data the from the Phase 2/3 RINGSIDE trial testing AL102 in desmoid tumors, a rare tumor of the connective tissue.  The data was from Part A, designed to test three dosing intervals for tolerability, safety, and select a dosing schedule for the double-blind, placebo-controlled Part B.  Patients receiving drug at intervals of either 1.2 mg daily, 2 mg for 2 days then 5 days rest, or 4 mg for 2 days then 5 days rest.  The 1.2mg daily dose was chosen for Part B.

The Stock Fell On The News.  We attribute the stock price decline to the selection of the lower dose given daily rather than one of the higher doses given in cycles.  The data from the daily dosing arm also had partial responses, rather than complete responses, although the effect improved over time.  We point out that Part A was designed to determine tolerability and select the dose for Part B, and the upcoming Part B with 156 patients will determine efficacy and approvability.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Why Biotech May Finish out 2022 Very Strong

Posted on by cpatches
Image Credit: Jason Mrachina (Flickr)

The Reasons Biotech is Gaining Ground on the Field

Similar to their watching a horse race, with a sense that their horse is starting to come from behind and may even be moving toward the front of the pack, biotech investors are leaning over the rail, watching their sector’s increased pace. This week biotechs, as measured by the ETF $XBI, crossed above its 200-day moving average – only last week the biotech sector’s momentum took it above its 50-day moving average. Does this technical indicator demonstrate the growing strength will continue, or does this indicate that it may be approaching overbought?

Technical analysis is not usually clear on this; below, we look for clues in the sector’s fundamentals to better handicap its chances.

Source: Koyfin

Pace of Deals

In 2021, the overall healthcare sector experienced record merger and acquisition activity. The first half of 2022 also had significant activity; however, at $92.4 billion in value and 481 deals announced, the pace of activity was down 51% from the same period in 2021. This may feel slow but is well ahead of the pre-pandemic pace for these companies.  For example, it’s a 37% increase from the first half of 2020. This could be seen as fundamentally positive for a sector that is trading below its 2021 levels and even below the second half of 2020. 

One catalyst for this continued high pace of deals which may even help accelerate it, is that big pharmacies are flush with cash. This cash serves them best if invested in the next generation of medicine or valuable patent. Fortunately for big pharma, small and mid-sized biotech companies are more likely now to form financial partnerships, agree to merger arrangements, or be outright purchased in order to help with their need for cash to continue operations.

This dynamic is easy to understand; there is less money flowing into the smaller incubator-type companies than the big pharmaceutical companies that have had money pouring in from generous pandemic-related government contracts. These small companies, many working on what may be life-changing science, rarely have sizeable sales. Sales and revenue come after the final phase of testing, FDA approval, and marketing. A small biotech company that sees its research and development possibly making a difference a few years from now, but is currently burning through capital at a pace where it may only last another 12 months, might welcome partnership or acquisition talks with a cash-rich suitor.

News of any injection of cash or capital in these smaller biotechs is usually an event that pushes the price up by percentage points in a short period of time. A full buyout can do much more.

XBI provides exposure to US biotech stocks, as defined by GICS, from a universe that invests across the market-cap spectrum. The fund equal-weights its portfolio, which in turn emphasizes small- and micro-caps and greatly reduces single-name risk. Thus, the weighted-average market-cap is much smaller than some competitors. Unlike other funds in this segment, XBI is a pure biotech play, with relatively small pharma overlap. The index is rebalanced quarterly.  – FactSet

Put yourself in the position of big pharma in 2022 into 2023. Your firm may now be sitting on a huge war chest thanks to the pandemic. This is now being eroded by high inflation. Management’s role is to use resources to provide value to shareholders. In the meantime, biotech is well-priced and motivated to talk.

And then the clock is always ticking on patent cliffs for big pharma. They may be very amenable to shop for acquisition targets as they look out at the expiration of patent rights and the exclusive protection those patents provide. Analysts estimate the top-ten pharmaceutical manufacturers have more than 46 percent of their revenues at risk between 2022 and 2030. Behemoths like Bristol Myers Squibb, Pfizer and Merck will be among the most exposed over the next decade.

Take Away

Watching a thoroughbred that was lagging behind the pack find an opening and begin to gain ground on those around it is exciting. When you have money on the horse, it’s even more enjoyable. The performance of the biotech sector was far behind other industries for much of this year. Moving into fall it has been outperforming its own average and many other investment areas.

There are fundamentals in play that could keep this strength going. What’s more is that these factors have little to do with the overall market, which many now fear

This challenge may catalyze M&A in the industry as large firms look to recoup lost revenue streams and invest in patents.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.nasdaq.com/articles/consolidation-case-for-biotech-etf-bbh

https://www.jdsupra.com/legalnews/big-pharma-firms-return-to-the-deal-6580128/