Release – BioSig Executes Purchase Agreement with Methodist Hospital, San Antonio and Expands Customer Base

Research, News, and Market Data on BSGM

October 07, 2022

Leading medical center in San Antonio acquires BioSig’s novel digital signal processing technology for arrhythmia care

Westport, CT, Oct. 07, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that San Antonio Methodist Hospital has acquired the PURE EP™ System.

The acquisition, one of many in the pipeline, reaffirms the continued expansion of BioSig’s U.S. footprint and customer base.

“As we continue to advance the national commercial rollout of the PURE EP™ System, we are thrilled to introduce our technology to Methodist Hospital in San Antonio,” said Gray Fleming, Chief Commercial Officer, BioSig Technologies, Inc. “We believe that the PURE EP™ System enhances EP lab infrastructure by integrating with existing workflows and delivers critical signals of interest that are not visible on conventional systems.”

“PURE EP™ delivers great value to our lab across many different types of ablations. By uncovering new levels of clarity of intracardiac signals, PURE EP™ opens doors to the benefits of signal processing in the digital domain,” commented David N. Pederson, MD, Clinical Cardiac Electrophysiologist, Methodist Hospital, San Antonio, TX.

About Methodist Healthcare

Methodist Healthcare is recognized as a leading healthcare provider in South Texas, offering an outstanding selection of doctors, healthcare professionals, equipment and health services. The hospital belongs to a network of hospitals in the greater San Antonio area, including nine acute care facilities: Methodist Hospital, Methodist Children’s Hospital, Methodist Hospital Metropolitan, Methodist Hospital Northeast, Methodist Hospital Atascosa, Methodist Hospital Specialty and Transplant, Methodist Hospital Stone Oak and Methodist Hospital Texsan. 

About BioSig Technologies

BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives.

The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy.

The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating.The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.1

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future 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 and consequently, actual 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) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. 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.

1 Global Market Insights Inc. March 08, 2022.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.

Released October 7, 2022

DLH Holdings (DLHC) – A New Contract


Friday, October 07, 2022

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

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.

Receiving More Work. Yesterday, management of DLH announced the Company was awarded an ID/IQ contract with the Department of Veteran Affairs (VA), as the award represents continued momentum of demand for DLH’s services. Additionally, on Monday the Defense Health Agency announced the continuation of a Blanket Purchase Master Agreement with a DLH operating subsidiary, Irving Burton Associates.

VA Contract. The VA contract for DLH is an ID/IQ multiple award contract to design, develop, and test innovations in healthcare. The Company will be competing as one of 17 prime awardees for orders in five categories including: personalized healthcare, data transformation, digital care, immersive technology, and care and service delivery. The contract has a base period of five years and has a $650 million ceiling.


Get the Full Report

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) – Ayala Holds KOL Event On AL102 and Desmoid Tumors


Friday, October 07, 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.

KOL Event Reviewed AL102 and Desmoid Tumors.  Ayala held a KOL webcast to discus AL102, its gamma secretase inhibitor, the current treatments for desmoid tumors, and AL102 clinical development.  After reviewing the RINGSIDE Phase 2/3 Part A dose-finding data, we continue to believe AL102 has potential to succeed in the placebo-controlled Part B portion.  We continue to rate the stock Market Perform due to the time required for the study and capital requirements.

Clinical Review.  The presentations began with a clinical review of desmoid tumors, the mechanism of action for AL102, and the AL102 clinical studies.  The RINGSIDE Phase 2/3 trial was designed in two parts, with Part A testing three regimens with different doses and administration schedules.  Safety and tumor volume were evaluated at 16 weeks, and data used to select one dose for Part B.  The results of Part A were announced in September 2022, with patients moving to an open label extension phase.


Get the Full Report

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. 

Pharmaceuticals Mimicking Exercise for a Healthier Population

Scientists Chart How Exercise Affects the Body

Anne Trafton | MIT News Office

Exercise is well-known to help people lose weight and avoid gaining it. However, identifying the cellular mechanisms that underlie this process has proven difficult because so many cells and tissues are involved.

In a new study in mice that expands researchers’ understanding of how exercise and diet affect the body, MIT and Harvard Medical School researchers have mapped out many of the cells, genes, and cellular pathways that are modified by exercise or high-fat diet. The findings could offer potential targets for drugs that could help to enhance or mimic the benefits of exercise, the researchers say.

“It is extremely important to understand the molecular mechanisms that are drivers of the beneficial effects of exercise and the detrimental effects of a high-fat diet, so that we can understand how we can intervene, and develop drugs that mimic the impact of exercise across multiple tissues,” says Manolis Kellis, a professor of computer science in MIT’s Computer Science and Artificial Intelligence Laboratory (CSAIL) and a member of the Broad Institute of MIT and Harvard.

The researchers studied mice with high-fat or normal diets, who were either sedentary or given the opportunity to exercise whenever they wanted. Using single-cell RNA sequencing, the researchers cataloged the responses of 53 types of cells found in skeletal muscle and two types of fatty tissue.

“One of the general points that we found in our study, which is overwhelmingly clear, is how high-fat diets push all of these cells and systems in one way, and exercise seems to be pushing them nearly all in the opposite way,” Kellis says. “It says that exercise can really have a major effect throughout the body.”

Kellis and Laurie Goodyear, a professor of medicine at Harvard Medical School and senior investigator at the Joslin Diabetes Center, are the senior authors of the study, which appears today in the journal Cell Metabolism. Jiekun Yang, a research scientist in MIT CSAIL; Maria Vamvini, an instructor of medicine at the Joslin Diabetes Center; and Pasquale Nigro, an instructor of medicine at the Joslin Diabetes Center, are the lead authors of the paper.

The Risks of Obesity

Obesity is a growing health problem around the world. In the United States, more than 40 percent of the population is considered obese, and nearly 75 percent is overweight. Being overweight is a risk factor for many diseases, including heart disease, cancer, Alzheimer’s disease, and even infectious diseases such as Covid-19.

“Obesity, along with aging, is a global factor that contributes to every aspect of human health,” Kellis says.

Several years ago, his lab performed a study on the FTO gene region, which has been strongly linked to obesity risk. In that 2015 study, the research team found that genes in this region control a pathway that prompts immature fat cells called progenitor adipocytes to either become fat-burning cells or fat-storing cells.

That finding, which demonstrated a clear genetic component to obesity, motivated Kellis to begin looking at how exercise, a well-known behavioral intervention that can prevent obesity, might act on progenitor adipocytes at the cellular level.

To explore that question, Kellis and his colleagues decided to perform single-cell RNA sequencing of three types of tissue — skeletal muscle, visceral white adipose tissue (found packed around internal organs, where it stores fat), and subcutaneous white adipose tissue (which is found under the skin and primarily burns fat).

These tissues came from mice from four different experimental groups. For three weeks, two groups of mice were fed either a normal diet or a high-fat diet. For the next three weeks, each of those two groups were further divided into a sedentary group and an exercise group, which had continuous access to a treadmill.

By analyzing tissues from those mice, the researchers were able to comprehensively catalog the genes that were activated or suppressed by exercise in 53 different cell types.

The researchers found that in all three tissue types, mesenchymal stem cells (MSCs) appeared to control many of the diet and exercise-induced effects that they observed. MSCs are stem cells that can differentiate into other cell types, including fat cells and fibroblasts. In adipose tissue, the researchers found that a high-fat diet modulated MSCs’ capacity to differentiate into fat-storing cells, while exercise reversed this effect.

In addition to promoting fat storage, the researchers found that a high-fat diet also stimulated MSCs to secrete factors that remodel the extracellular matrix (ECM) — a network of proteins and other molecules that surround and support cells and tissues in the body. This ECM remodeling helps provide structure for enlarged fat-storing cells and also creates a more inflammatory environment.

“As the adipocytes become overloaded with lipids, there’s an extreme amount of stress, and that causes low-grade inflammation, which is systemic and preserved for a long time,” Kellis says. “That is one of the factors that is contributing to many of the adverse effects of obesity.”

Circadian Effects

The researchers also found that high-fat diets and exercise had opposing effects on cellular pathways that control circadian rhythms — the 24-hour cycles that govern many functions, from sleep to body temperature, hormone release, and digestion. The study revealed that exercise boosts the expression of genes that regulate these rhythms, while a high-fat diet suppresses them.

“There have been a lot of studies showing that when you eat during the day is extremely important in how you absorb the calories,” Kellis says. “The circadian rhythm connection is a very important one, and shows how obesity and exercise are in fact directly impacting that circadian rhythm in peripheral organs, which could act systemically on distal clocks and regulate stem cell functions and immunity.”

The researchers then compared their results to a database of human genes that have been linked with metabolic traits. They found that two of the circadian rhythm genes they identified in this study, known as DBP and CDKN1A, have genetic variants that have been associated with a higher risk of obesity in humans.

“These results help us see the translational values of these targets, and how we could potentially target specific biological processes in specific cell types,” Yang says.

The researchers are now analyzing samples of small intestine, liver, and brain tissue from the mice in this study, to explore the effects of exercise and high-fat diets on those tissues. They are also conducting work with human volunteers to sample blood and biopsies and study similarities and differences between human and mouse physiology. They hope that their findings will help guide drug developers in designing drugs that might mimic some of the beneficial effects of exercise.

“The message for everyone should be, eat a healthy diet and exercise if possible,” Kellis says. “For those for whom this is not possible, due to low access to healthy foods, or due to disabilities or other factors that prevent exercise, or simply lack of time to have a healthy diet or a healthy lifestyle, what this study says is that we now have a better handle on the pathways, the specific genes, and the specific molecular and cellular processes that we should be manipulating therapeutically.”

Reprinted with the permission  MIT News http://news.mit.edu/

Release – Schwazze Announces Virtual Town Hall Meeting

Research, News, and Market Data on SHWZ

October 6, 2022

DENVER, Oct. 6, 2022 /PRNewswire/ – Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), is pleased to announce that Justin Dye, Chairman & CEO will present to investors in a live VID Forum Town Hall on Tuesday, October 11, 2022, at 11:00 am EST.  Management will field moderated Q&A from investors and interested parties after their presentation.  Please sign up here to register.

 The Webinar will be interactive and will be hosted by VID Conferences.  All stakeholders and interested investors are welcome to tune in and participate with questions. The playback will then be available on the Company’s website.

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,”, “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 and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, * the timing and extent of governmental stimulus programs, (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws, and * out ability to satisfy the closing conditions for the private finding described in this press release. 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.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/schwazze-announces-virtual-town-hall-meeting-301642847.html

SOURCE Medicine Man Technologies, Inc.

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, Inc. to Present at Upcoming Vaccines, Cell and Gene Therapy Conferences

Research, News, and Market Data on OCGN

October 6, 2022

MALVERN, Pa., Oct. 06, 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 that the Company will present at two important conferences this month.

“I look forward to sharing more about our Modifier Gene Therapy platform—a novel approach to treating inherited retinal disease—during the Meeting on the Mesa, and Dr. Hopkins will provide more on COVAXIN™— a whole-virion inactivated COVID-19 vaccine candidate currently in a Phase 2/3 immuno-bridging and broadening clinical trial with the U.S. FDA—at the Vaccines Summit,” said Dr. Shankar Musunuri, PhD, MBA, Chairman, CEO & Co-Founder of Ocugen. “It’s critical that we participate in conversations about the next generation of medicine among our peers and share our contributions to the advancement of vaccines, cell and gene therapy.”

2022 Cell & Gene Meeting on the Mesa

Title: Our Commitment to Gene & Cell Therapy
Presenter: Dr. Shankar Musunuri
Date: Wednesday, October 12, 2022
Time: 2 p.m. PT
Location: Park Hyatt Aviara, Carlsbad, CA

Vaccines Summit 2022

Title: COVAXIN™: A whole SARS-CoV-2 virion inactivated vaccine against COVID-19
Presenter: Robert J. Hopkins, MD, MPH & TM, FACP, FIDSA, Chief Medical Officer
Date: Wednesday, October 12, 2022
Time: 6:10 – 6:30 p.m. ET
Location: Sheraton Reston Hotel, Reston, VA

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

The Biotech Field That’s Getting Big Pharma’s Attention at the Earliest Stages

Image Credit: Ed Schipul (Flickr)

Small Biotech Field with Big Promise

A silver bullet cure, with possible indications for 150 illnesses or more, is now being researched by a few small biotech companies. The results have gotten the attention of big pharmaceutical companies.

In the world of biology, medicine, and biotechnology, there’s a new and extremely promising field of research in inflammasomes. Since the discovery 20 years ago, increasing understanding of what causes inflammation or an inflammatory response in humans and the knowledge of the mechanisms and role of inflammasomes has developed into a race to design potential drugs which target the culprit in many diseases. The problem to be solved is an overly zealous inflammatory response.

The activation of the inflammation system is to protect the body from pathogens, injury, or other dangers or irritants. While insufficient inflammation can lead to persistent infection or problems related to the initial trigger, excessive inflammation can cause chronic or systemic inflammatory diseases. While there are many medications, both over-the-counter and by prescription, to help reduce inflammation and problems associated with it, a therapy or therapies upstream could prevent an over-inflammation response at the source.

Currently, the rapid expansion of knowledge of inflammasomes’ role in various diseases has uncovered links to neurological diseases such as Parkinson’s, Alzheimer’s, and MS; metabolic disorders including type2 diabetes, and obesity; and cardiovascular diseases.

Currently, there are no approved inflammasome inhibitors; however, there are several promising early-stage trials occurring at a few focused companies. Development of therapies is the goal, with expectations of them being able to treat a myriad of ailments. Success could be similar to the discovery of penicillin when many infections quickly ceased being worrisome. The breakthrough could provide therapy or a mechanism to control one or two key inflammasomes that could suddenly provide cures or relief from many chronic problems.

Over the past few years, these inflammasome-related transactions, acquisitions, and partnerships have taken place:

Ventus Therapeutics- On September 29, 2022, Ventus received $70 million upfront, with the agreement for additional milestones of up to $633 million, also royalty payments and R&D funding from Novo Nordisk to license Ventus’s brain penetrant inflammasome (NLRP3) inhibitor – Ventus is a privately held company that retains full rights.

Cerevance – August 9, 2022 Cerevance received $25 million upfront, with the agreement for additional milestones up to $1.1 billion, with potential for royalty payments from Merck on sales of approved products derived from the strategic research collaboration of Alzheimer’s targets using Cerevance’s NetSseq platform. (Pre-clinical phase)

Inflamazome – September 21, 2020 Inflamazome was fully acquired for $451 million upfront with R&D milestones that could be worth up to $1.125 billion from Roche. Roche will own full rights to the acquired company’s portfolio of oral NLRP3 small molecule inflammasome inhibitors. (Pre-clinical phase and Phase 1)

IFM Therapeutics – Quattro & IFM Discovery (Incubator) – December 2019, Has raised $55.5 million to launch its third drug subsidiary as well as an incubator, both of which are focused on developing new therapies for inflammatory diseases and cancers. Omega Funds was the lead, with Atlas Ventures also participating. Financing lead: Omega Funds also participating: Atlas Ventures. (Discovery Phase)

Inflammasome Therapeutics – September 2019,  Is entitled to receive up to $160 million in milestone and gated development payments and tiered royalties and other milestones due on commercialization from Boehringer Ingelheim. (Development Phase)

IFM Therapeutics – September 2019, Agreement provides sufficient funding for research and development costs through late-stage pre-clinical development of the lead program with an option to acquire IFM Due. IFM is a Privately held company. (Discovery Phase)

IFM Therapeutics- April 1, 2019, the subsidiary IFM Tre was acquired by Novartis. Novartis will pay $310 million upfront and up to roughly $1.3 billion in milestones to access three early-stage NLRP3 antagonists: IFM-2427, a systemically acting compound that began its first human studies last week, and two pre-clinical compounds: one gut-penetrating, and the other directed at the central nervous system. (Clinical Phase and Pre-clinical Phases)

Most of the small companies involved in inflammasome research are privately held and raise capital privately. From time to time, Noble Capital Markets may be involved in raising capital for non-public biotech firms and companies in other industries. To determine in advance if you qualify to invest in non-public capital raises, visit here to request accreditation.

Take Away

There are huge amounts of capital coming primarily from big pharma and venture capital firms with the expectation that R&D on inflammasomes could yield big results. Therapies that could regulate a primary culprit across many diseases would be a significant boost to investors and mankind.

Paul Hoffman

Managing Editor, Channelchek

https://www.channelchek.com/news-channel/inflammasomes_panel_from_noblecon16

https://www.sciencedirect.com/science/article/abs/pii/S0091674916302834

https://www.frontiersin.org/articles/10.3389/fimmu.2022.834289/full

https://www.ventustx.com/news/ventus-therapeutics-enters-exclusive-development-and-license-agreement-

https://cerevance.com/2022/08/09/cerevance-establishes-strategic-research-collaboration-with-merck-for-the-discovery-of-novel-targets-in-alzheimers-disease/

https://www.biospace.com/article/roche-dives-into-nlrp3-inflammasome-inhibition-with-acquisition-of-inflazome/

https://www.biospace.com/article/roche-dives-into-nlrp3-inflammasome-inhibition-with-acquisition-of-inflazome/

https://xconomy.com/boston/2019/12/02/ifm-lands-55-5m-to-launch-newco-quattro-and-discovery-incubator/

https://www.inflam.com/images/pdfs-doc/Inflammasome_BI_release_September_20_2019_1.pdf

https://www.ifmthera.com/news/ifm-therapeutics-announces-collaboration-and-exclusive-option-agreement-for-cgas-sting-focused-subsidiary-ifm-due/

https://cen.acs.org/pharmaceuticals/Novartis-acquire-inflammasome-focused-IFM/97/web/2019/04

https://www.the-scientist.com/bio-business/pharma-looks-to-inflammasome-inhibitors-as-all-around-therapies-68582

Release – Cocrystal Pharma to Present at the Dawson James Securities 2022 Small Cap Growth Conference

Research, News, Market Data on COCP

OCTOBER 05, 2022

BOTHELL, Wash., Oct. 05, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that James Martin, CFO and interim co-CEO, will present a company overview at the Dawson James Securities 2022 Small Cap Growth Conference on Wednesday, October 12, 2022 at 1:00 p.m. Eastern time (10:00 a.m. Pacific time). The conference is being held at the Wyndham Grand Hotel in Jupiter, Fla.

Mr. Martin is available throughout the conference for one-on-one meetings. The Cocrystal presentation will be posted to the IR Calendar of the Company’s website beginning October 12.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

ChitogenX Inc. (CHNXF) – Expanding Opportunities, FQ2 2023 Reported.


Tuesday, October 04, 2022

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.

FQ2 2023 reported for period ending July 31, 2022.  As a clinical stage company, ChitogenX reported no revenues in the quarter. Expenses, both G&A and R&D, were lower than our quarter expectations, offset by higher share-based compensation expense. R&D expenses were reduced by a $500,000 (all figures in C$) grant received in May 2022 to advance the meniscus repair indication.  The result was a net loss of $1.363 million vs. expected $1.59 million.  Loss per share was $0.03 vs. expected loss of $0.03.

ChitogenX is pushing well beyond orthopedics.  The rebranding recently instituted was more than a simple name change.  The Company is leveraging its chitosan biopolymer technology expertise to attack a much larger global regenerative medicine market, including areas like oncology, neurology, and cardiology. Regenerative medicines have an inherent inability to stick to repair sites and ChitogenX seeks to resolve the problem with their ChitogenX Biopolymer. We expect the Company to establish partnerships, license the technology, or seek grants in these additional markets.


Get the Full Report

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 – Schwazze Opens Another New Mexico Cannabis Dispensary Located In Clovis; Brings Total R.Greenleaf Count to 12 Stores

Research, News, and Market Data on SHWZ

Grand Opening Event Scheduled for Saturday, October 15th

DENVER, Oct. 4, 2022 /PRNewswire/ – Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), a premier vertically integrated, multi-state operating cannabis company with assets in Colorado and New Mexico, announces the grand opening of its adult-use dispensary, R.Greenleaf, located in Clovis, New Mexico. The new store, located at 2009 Ross Street in Clovis, officially opened its doors for business on Saturday, October 1st. Regular store operating hours are 9a to 8p Sunday through Saturday.

This store opening continues the deliberate expansion throughout the state of New Mexico and comes on the heels of the September 24th store opening in Ruidoso. This brings R.Greenleaf’s number of New Mexico retail dispensaries to 12. All locations serve the needs of medical patients as well as recreational adult-use consumers.

“Schwazze is excited to add our second new retail dispensary in New Mexico within the last week and since adult recreational cannabis was legalized in New Mexico on April 1st,” said Steve Pear, New Mexico Division President for Schwazze. “We are honored to bring our support to the Clovis community. R.Greenleaf offers a wide variety of quality products and is serviced by top-notch, knowledgeable staff.”

Grand opening product specials and promotions are already in full swing with multiple flower pack offers, pre-rolls, gummies, chocolates and distillate vaporizer cartridges. Bundled kits, deals and cannabis product starter packs will be offered to provide patients and recreational customers a variety of product forms and consumption methods based on individual needs and preferences.

A grand opening celebration will be held on Saturday, October 15th beginning at 9a and running until 2p. Swag bags will be available to the first 75 shoppers with one lucky customer receiving a 50% discount coupon. Music will accompany a food truck offering free burritos and tacos to the first 75 customers making a purchase.

Clovis Store Location
R.Greenleaf
2009 Ross Street
Clovis, New Mexico 88101

Grand Opening Celebration
Saturday, October 15th
9a to 2p

Since April 2020, Schwazze has acquired, opened or announced the planned acquisition of 37 cannabis retail dispensaries as well as seven cultivation facilities and two manufacturing plants 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, * 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.

SOURCE Schwazze

Release – Lineage to Present at Alliance for Regenerative Medicine 2022 Cell and Gene Meeting on the Mesa

Research, News, and Market Data on LCTX

October 4, 2022 at 8:00 AM EDT

CARLSBAD, Calif.–(BUSINESS WIRE)–Oct. 4, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Brian M. Culley, Lineage’s Chief Executive Officer, will present at the Alliance for Regenerative Medicine 2022 Cell & Gene Meeting on the Mesa, on October 12th, 2022 at 2:15pm PT / 5:15pm ET at the Park Hyatt Aviara, Carlsbad, CA. Virtual meeting attendance is available and includes a livestream of Lineage’s presentation and the ability to view all conference sessions on-demand. Interested parties can visit the 2022 Cell & Gene Meeting on the Mesa website for full information on the conference, including registration.

The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies. The program features expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and dedicated presentations by the leading publicly traded and privately held companies in the space. This conference enables key partnerships through more than 3,000 one-on-one meetings while highlighting the significant clinical and commercial progress in the field.

About the Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-engineered therapies. In its 13-year history, ARM has become the global voice of the sector, representing the interests of 450+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

View source version on businesswire.comhttps://www.businesswire.com/news/home/20221004005157/en/

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

LifeSci Advisors
Daniel Ferry
(daniel@lifesciadvisors.com)
(617) 430-7576

Russo Partners – Media Relations
Nic Johnson or David Schull
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

PDS Biotechnology Corp (PDSB) – PDS0101 To Advance To Phase 3 In First Indication


Tuesday, October 04, 2022

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

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.

PDS Biotech Announces FDA Meeting Results.  PDS Biotech announced the outcome of an End-of-Phase 2 meeting with the FDA to determine the clinical development pathway for PDS0101.  In the meeting, data from the interim analysis of the VERSATILE-002 trial testing PDS0101 in HPV-positive head-and-neck cancer was evaluated and regulatory guidance provided.  Although the trial is still ongoing, the efficacy and safety data will allow moving into a Phase 3 pivotal study ahead of schedule during 2023.

VERSATILE-002 Showed Strong Response Rates.   The VERSATILE-002 Phase 2 trial was designed to test PDS0101 in HPV-positive cancer of the head and neck in combination with the checkpoint inhibitor pembrolizumab (Keytruda, from Merck).  As discussed in our Research Note reviewing the data at the ASCO conference last May 31, the tumor response rate (shrinkage of 30% or more) was 41.2% (7 out of 17 patients).  This compares with published data showing 19% response rate for checkpoint inhibitors alone.  Progression-free survival (PFS) at nine months was 55.2% and overall survival (OS) was 87.2%.


Get the Full Report

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 – Cocrystal Pharma Announces a 1-for-12 Reverse Stock Split

Research, News, and Market Data on COCP

OCTOBER 03, 2022

BOTHELL, Wash., Oct. 03, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces that its Board of Directors has approved a 1-for-12 reverse stock split of the Company’s common stock. Cocrystal’s common stock is expected to begin trading on a split-adjusted basis at commencement of trading on Tuesday, October 11, 2022.

The reverse stock split will support maintenance of the Company’s Nasdaq Capital Market’s listing. On November 16, 2021, Nasdaq Capital Markets LLC notified the Company that the Company was not compliant with Nasdaq Rule 5550(a)(2) by failing to be above $1.00 per share for 30 consecutive trading days. The purpose of the reverse split is to regain compliance with Nasdaq’s Rule and avoid delisting of its common stock.

The reverse stock split will reduce the number of shares of Cocrystal’s common stock outstanding from approximately 97.5 million shares to approximately 8.1 million shares, but will not change the authorized number of shares of common stock, which will remain at 150 million shares of common stock. The Company’s common stock will continue to trade on the Nasdaq Capital Market under the symbol “COCP.”

The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. No fractional shares will be issued in connection with the reverse stock split. Fractional shares resulting from the reverse split will be rounded up to the nearest whole share. Holders of the Company’s common stock held in book-entry form or through a bank, broker or other nominee do not need to take any action in connection with the reverse stock split. Stockholders of record will be receiving information from the Company’s transfer agent regarding their common stock ownership post-reverse stock split.

In addition, pursuant to their terms, a proportionate adjustment will be made to the per share exercise price and number of shares issuable under all of the Company’s outstanding equity awards, and the number of shares authorized and reserved for issuance pursuant to the Company’s equity incentive plans will be reduced proportionately.

Furthermore, pursuant to their terms, a proportionate adjustment will be made to the per share exercise price and number of shares issuable under all of the Company’s outstanding warrants.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

Source: Cocrystal Pharma, Inc.

Released October 3, 2022