Category: Health

Release – BioSig Invited to Attend and Sponsor Venice Arrhythmias 2022

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on BSGM

October 12, 2022

Company to introduce its novel digital signal processing technology to the European EP community at world-renown international congress

Westport, CT, Oct. 12, 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 it has been invited to attend the 17th Edition Venice Arrhythmias 2022 Congress—a Heart Rhythm Society sponsored program taking place from October 13-15, 2022 in Venice, Italy.

During the event, BioSig’s leadership and commerical teams will introduce the PURE EP™ System to the European EP (electrophysiology) market for the first time. Following the recent launch of PURE EP™ Software Version 6 with ACCUVIZ™ Module, the Company will be showcasing the highly differentiated features of its digital signal processing technology, which includes advanced signal processing automation, elevated visualization of clear cardiac signal information, and TRUSOURCE™, a comprehensive procedural analysis and report.

“It is an honor to be interacting with many talented physicians who are breaking new ground in electrophysiology science. Their research is impacting technological advancement in the industry,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.  “I could not be more excited to demonstrate how the PURE EP™ System can provide deeper clinical insights and simplify procedural workflows to this science-based community. As a company, we celebrate their clinical legacy and embody their investment in this critical field of healthcare.”

About Venice Arrhythmias 2022

Venice Arrhythmias 2022 is a world-renown congress that convenes global experts and innovators in the field of heart rhythm disorders to discuss the latest scientific advances and cutting-edge technologies in cardiac electrophysiology, pacing, and clinical arrhythmology. This year’s—17th edition— program will be led by course directors and presidents of the Venice Arrhythmias Congress: Andrea Natale, MD, FHRS, Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas; Sakis Themistoclakis, MD, PhD, Director of Cardiology of Dell’Angelo Hospital in Venice-Mestre, Italy; and Antonio Raviele, MD, FHRS, President of the Alliance to Fight Atrial Fibrillation (ALFA).

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 12, 2022

Release – PDS Biotech to Host Head and Neck Cancer KOL Roundtable on October 26, 2022

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on PDSB

FLORHAM PARK, N.J., Oct. 12, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB),  a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced it will host a Head and Neck Cancer Key Opinion Leader (KOL) Roundtable for analysts, investors, and the scientific community from 8:30 – 9:30 AM ET on Wednesday, October 26, 2022.

This PDS Biotech-sponsored event will focus on the current treatment of head and neck cancer and how PDS0101, the company’s leading product candidate, which combines the utility of the Versamune® platform with targeted antigens in HPV-positive cancers, might fit into the treatment paradigm. The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren Wood and will feature presentations from the following head and neck cancer KOLs:

  • Dr. Neil D. Gross, Department of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center
  • Dr. Katharine A. Price, Co-chair, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center
  • Dr. Jared Weiss, Head and Neck Cancer Section Chief, Lineberger Comprehensive Cancer Center, UNC School of Medicine

Registration for PDS Biotech’s KOL Roundtable is now open, and a live webcast of the event will be available online in the investor relations section of the company’s website at https://pdsbiotech.com/investors/news-center/events. A replay will be available on the company website for 90 days following the webcast.

About PDS Biotechnology 

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech. 

About PDS0101 

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-positive cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A Phase 2 clinical study is also being conducted in both second- and third-line treatment of multiple advanced HPV-positive cancers in partnership with the National Cancer Institute (NCI). A third Phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.  A final Phase 2 clinical trial of PDS0101 monotherapy in first line treatment of newly diagnosed patients HPV16-positive head and neck cancer patients is being conducted at the Mayo Clinic.  

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. 

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

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

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contact:
Dave Schemelia
Tiberend Strategic Advisors Inc.
Phone: +1 (609) 468-9325
Email: dschemelia@tiberend.com

Bill Borden
Tiberend Strategic Advisors Inc.
Phone: +1 (732) 910-1620
Email: bborden@tiberend.com

Release – Schwazze Announces Management Changes to Support The Next Phase Of Company’s Growth

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on SHWZ

October 12, 2022

OTCQX: SHWZ
NEO: SHWZ

DENVER, Oct. 12, 2022 /CNW/ – Medicine Man Technologies operating as Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), announces the following leadership changes within the Company’s team:

President

Nirup Krishnamurthy, Chief Operating Officer, will become President of Schwazze effective immediately. Nirup will assume oversight and responsibility for strategic planning, growth initiatives in core markets, and operational execution. He will work with the Executive Leadership Team (“ELT”) to accelerate innovation, growth, and performance. The ELT will report directly to him.  Nirup will continue to report directly to Justin Dye, Chairman and CEO of Schwazze. 

Nirup joined Schwazze in 2020, bringing more than 25 years of experience in innovation, technology, retail operations and M&A at Fortune 500 companies. Nirup has played an integral role in building the Company and growing revenue from $9 million to a run-rate of $176 million and run-rate EBITDA of $60 million.  Under his leadership, Schwazze has grown from less than 20 employees to over 725 today.  Prior to joining the Company, he held C-level roles with United Airlines, Northern Trust Bank and former national grocery retailer A&P. He earned a bachelor’s in Mechanical Engineering and a doctorate in Industrial Engineering from State University of New York, Buffalo.

Chief Financial Officer

Nancy Huber, Chief Financial Officer, has announced that she will be retiring from Schwazze due to personal reasons. Nancy will remain with the Company as CFO for an indefinite period of time while an active search for her replacement is being conducted and to ensure an orderly transition of responsibilities.

Nancy was appointed to the position of CFO in 2019 and her breadth and depth of experience in financial oversight of publicly held companies has been instrumental in helping Schwazze grow into the multi-faceted, vertical operator that it is today; from less than 20 employees in 2019 to over 725 in two states today.

Nancy’s background includes 30+ years in multifunctional management, strategic planning, IPOs, mergers and acquisitions, SEC reporting, investor relations, intellectual property and systems implementation. Nancy earned her bachelor’s in chemical engineering from Purdue University and an MBA from the Kellogg School of Management.

The Board of Directors thanks Nancy for her important contributions to the Company and wishes her well in her future endeavors.  Effective immediately, a search for a CFO has been initiated by the Board.

Justin Dye, Chairman stated: “I am very pleased to announce Nirup’s promotion to President of Schwazze.  Nirup has delivered results and been a strong leader for the Company. There will be continuity of strategy under Nirup’s leadership, which I am confident will lead to Company growth.  On behalf of Schwazze’s Board of Directors, we look forward to his expanded leadership role within the Company supporting our continued development into the most Admired Cannabis Companies in the industry. I will continue my role as CEO and Chairman of the Board of Directors providing strategic direction and oversight.” Justin continued; “I would also like to acknowledge the hard work, dedication, and leadership that Nancy has brought to the Company as CFO. We are sad to see her leave her position as a key member of our leadership team. I would like to thank her personally, for her time here at Schwazze and on behalf of the Board, we wish her the very best in her future.“

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-management-changes-to-support-the-next-phase-of-companys-growth-301646925.html

SOURCE Medicine Man Technologies, Inc.

PDS Biotechnology Corp (PDSB) – Interim Update From Triple-Therapy Trial Shows Continued Survival Benefit

Posted on by cpatches


Wednesday, October 12, 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.

Survival Data Extended To 16 Months.  PDS Biotech announced an interim data update from its Phase 2 clinical trial testing PDS0101 in combination with two immunotherapy drugs (bintrafusp alfa, a bifunctional checkpoint inhibitor and IL-12, an immunocytokine).  This trial is being conducted at the National Cancer Institute and is known as the “NCI trial” or the “Triple-Therapy” trial. 

Trial Design. The study enrolled patients with HPV-positive tumors of multiple tissues who had failed prior therapy.  Patients were stratified into two arms, separating those that had not received checkpoint inhibitor (CPI naive) therapy from those that had progressed after receiving CPI therapy (CPI refractory). Patients received a combination of PDS0101 with M9241, a tumor-targeting IL-12, and bintrafusp alfa, a bifunctional checkpoint inhibitor.  Following the interim data announcement at the ASCO Meeting in May 2022, PDS announced that it would move forward to pivotal trials in CPI refractory patients.


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 – PDS Biotech Announces Expanded Interim Data in PDS0101 Triple Combination Phase 2 Trial Targeting Advanced HPV-Positive Cancers

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on PDSB

66% of HPV 16-positive checkpoint inhibitor refractory patients are alive at median follow up of 16 months

FLORHAM PARK, N.J., Oct. 11, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced expanded interim data in the Phase 2 clinical trial investigating the PDS0101-based triple combination therapy in advanced human papillomavirus (HPV)-positive cancers.   This Phase 2 study is being conducted at the Center for Cancer Research (CCR) at the National Cancer Institute (NCI), one of the Institutes of the National Institutes of Health. The interim efficacy data from 37 HPV16-positive evaluable patients, including 29 patients in the checkpoint inhibitor (CPI) refractory arm, are consistent with the results presented at ASCO 2022 and affirm the selection of CPI refractory patients as the initial patient population for ongoing clinical development of the triple combination.

The NCI-led Phase 2 clinical trial (NCT04287868) is investigating PDS0101 in combination with two investigational immune-modulating agents – M9241, a tumor-targeting IL-12 (immunocytokine), and bintrafusp alfa, a bifunctional checkpoint inhibitor (PD-L1/ TGF-β) – in recurrent or metastatic HPV-positive cancers in patients who have failed prior therapy. The triple combination is being studied in CPI-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers. Both M9241 and bintrafusp alfa are owned by Merck KGaA, Darmstadt, Germany.

Highlights of the expanded interim data are as follows:

  • Survival data: 66% (19/29) of HPV 16-positive CPI refractory patients in the cohort were alive at a median follow up of 16 months.  Historically, this group has a median overall survival of only 3-4 months. i
  • Safety profile: 48% (24/50) of patients experienced Grade 3 treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 AEs. There were no grade 5 treatment-related AEs

Results for HPV 16-positive checkpoint inhibitor naïve patients also continue to appear to be encouraging: 75% (6/8) of CPI naïve patients were alive at a median of 25 months of follow up. 38% (3/8) of responders had a complete response. 

“The expanded interim data investigating the PDS0101-based triple combination therapy in advanced HPV-positive cancers continue to appear to show clinical signs of efficacy, durability and safety in an extremely challenging patient population with very few available treatment options,” stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “Importantly, these results affirm the decision to explore this novel combination for the treatment of CPI refractory patients, who have no approved standard of care, and support development of a combination therapy to address the significant unmet need.”

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-positive cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A Phase 2 clinical study is also being conducted in both second- and third-line treatment of multiple advanced HPV-positive cancers in partnership with the National Cancer Institute (NCI). A third phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

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

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
pdsb@cg.capital

Media
Dave Schemelia
Tiberend Strategic Advisors, Inc.
Phone: +1 (609) 468-9325
dschemelia@tiberend.com

Bill Borden
Tiberend Strategic Advisors
Phone: +1 732-910-1620
bborden@tiberend.com

Release – Cocrystal Pharma Selects CDI-988 for Clinical Development as an Oral Treatment for COVID-19

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on COCP

OCTOBER 11, 2022

BOTHELL, Wash., Oct. 11, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces the selection of its novel, broad-spectrum antiviral drug candidate CDI-988 for clinical development as an oral treatment for SARS-CoV-2, the virus that causes COVID-19. CDI-988 targets a highly conserved region in the active site of SARS-CoV-2 main (3CL) protease required for viral replication, and was specifically designed and developed as an oral antiviral candidate for COVID-19 using Cocrystal’s proprietary structure-based drug discovery platform technology.

In January 2022 the Company announced its intention to evaluate two oral protease inhibitors prior to selecting a lead candidate for clinical development. Both CDI-988 and the other candidate exhibited superior in vitro potency and broad-spectrum antiviral activity against SARS-CoV-2 and other coronaviruses. In preclinical studies, both candidates demonstrated favorable safety profiles and pharmacokinetic properties supportive of oral administration for the treatment of COVID-19.

“We reached the decision to move forward with clinical development of CDI-988 based on its distinct mechanism of action including an exceptionally strong affinity to the SARS-CoV-2 3CL (or main) protease compared to the known protease inhibitors and superior broad-spectrum antiviral activity against other RNA viruses,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “We are very excited about the selection of the first oral clinical candidate among our proprietary protease inhibitors.

In addition to COVID-19 antivirals, we are committed to developing potential best-in-class antiviral therapeutics to protect people worldwide from the threats of viral diseases,” he added. “Upon completion of IND-enabling toxicology studies of CDI-988, we plan to file for regulatory approval to begin a first-in-human trial in Australia in the first quarter of 2023.”

About SARS-CoV-2
SARS-CoV-2 is part of a family of coronaviruses that historically has been associated with a wide range of responses in infected individuals, ranging from no symptoms to severe disease that includes pneumonia, severe acute respiratory syndrome (SARS), kidney failure and death. By targeting the viral replication enzymes and protease, Cocrystal believes it is possible to develop an effective treatment for all illnesses caused by coronaviruses including COVID-19, SARS and Middle East Respiratory Syndrome. 

Cocrystal is executing on a strategy to develop highly potent and safe pan-coronavirus antivirals for SARS-CoV-2 and its variants for hospitalized and non-hospitalized patients, as well as for prophylactic use by uninfected individuals.

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.

Cocrystal Pharma Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our completing IND-enabling toxicology studies and the timing of our filing the Australian regulatory submission. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the uncertainties arising from any future impact of COVID-19 including in Australia, the Russian invasion of Ukraine, and/or inflation and Federal Reserve interest rate increases in response thereto on the global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our program with our research with CDI-988. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2021. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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

Release – MustGrow Receives Conditional Approval to Up-List to the TSX Venture Exchange

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on MGROF

Saskatoon, Saskatchewan–(Newsfile Corp. – October 11, 2022) – MustGrow Biologics Corp. (CSE: MGRO) (OTCQB: MGROF) (FSE: 0C0) (the “Company” or “MustGrow“), is pleased to announce that it has received conditional approval to list its common shares on the TSX Venture Exchange (the “TSXV”). The listing is subject to the Company fulfilling certain requirements of the TSXV in accordance with the terms of its conditional approval letter dated October 6, 2022.

MustGrow is actively working to satisfy the requirements and conditions that were highlighted in the approval letter and management is confident that all conditions for listing will be met in the coming weeks. Upon obtaining final approval, the Company will issue an additional news release to inform shareholders when it anticipates that its common shares will commence trading on the TSXV.

Upon completion of the final listing requirements, the Company’s common shares will be delisted from the Canadian Securities Exchange (the “CSE”) and commence trading on the TSXV under the trading symbol “MGRO”. MustGrow’s common shares will continue to trade on the OTCQB market under the symbol “MGROF” and on the Frankfurt Stock Exchange under the symbol “0C0”.

———

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 150 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 49.7 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; (iv) expected outcomes from collaborations with commercial partners, (v) the ability of the Company to satisfy the TSXV’s requirements and conditions for final approval to list its common shares on the TSXV; and (vi) the timing and commencement of trading of the Company’s common shares on the TSXV.

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, the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the CSE and TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2022 MustGrow Biologics Corp. All rights reserved.

Release – Lineage Announces Notice of Allowance of Two Patents Covering Processes for Manufacturing Allogeneic Oligodendrocyte Progenitor and Retinal Pigmented Epithelium Cells

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on LCTX

October 10, 2022 at 8:00 AM EDT

CARLSBAD, Calif.–(BUSINESS WIRE)–Oct. 10, 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 the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance to grant a patent for the Company’s U.S. patent application No. 16/750,975, entitled “Dorsally-Derived Oligodendrocyte Progenitor Cells From Human Pluripotent Stem Cells,” with claims covering proprietary manufacturing processes developed by Lineage for its oligodendrocyte progenitor cell therapy candidate (OPC1) for the treatment of spinal cord injury (SCI). The patent, which is expected to be issued in the coming months, would have a term that would expire no earlier than 2040. Additionally, the Company announced that the European Patent Office (EPO) has issued a notice of Intention to Grant a patent for Lineage’s patent application entitled “Preparation of Retinal Pigment Epithelium Cells,” (European Patent Application 16753990.7).

“These new patents highlight our ability to generate differentiated cell types from undifferentiated pluripotent cells and are valuable outputs from our platform. The production of specific cell lineages in a controlled and reproducible manner, on platforms which can support large-scale clinical trials, provide us with an important competitive advantage,” stated Brian M. Culley, Lineage CEO. “In addition to extending the patent coverage of our assets, new IP can also permit us to protect our programs without relying on patents licensed or obtained from third parties, which may reduce or eliminate payments to such third parties and retain more value for Lineage.”

Lineage aims to provide cell-based therapeutic benefits to patients by replacing cells lost due to disease, aging, or in the case of spinal cord injury, a traumatic event. The Company currently is focused on preparing for a planned interaction with the U.S. Food and Drug Administration (FDA) this quarter to discuss its OPC1 Investigational New Drug (IND) amendment submission, which would enable the clinical performance and safety testing of an improved delivery system to administer OPC1 in both acute and chronic spinal cord injury patients. In support of the Company’s planned regulatory interactions, most of the verification and validation activities for this novel parenchymal spinal delivery system and its preclinical testing have been completed, with additional preclinical activities also near completion.

About OPC1

OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements to motor recovery in individuals with acute spinal cord injuries (SCI). OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. SCI occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. and there currently are no FDA-approved drugs specifically for the treatment of SCI. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).

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.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the issuance of patents within the coming months and their terms for expiration; the potential value and benefits of these patents; any potential competitive advantages of our cell production capabilities; our ability to reduce or eliminate third-party payments through the development of new intellectual property; our collaboration and license agreement with Roche and Genentech and the timing of anticipated FDA interactions, preclinical activities, clinical trials, and clinical data updates related to our programs. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that patents we expect to be issued may not be issued as soon as expected or at all, or if issued, may expire earlier than expected; that potential benefits of newly developed intellectual property to the Company may not be realized as quickly as expected or at all; that we may need to allocate our cash to unexpected events and expenses causing us to use our cash more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that we may not establish new partnerships or expand existing collaborations; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221010005173/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.

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

Posted on by aweinsoff@channelchek.com

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

Posted on by cpatches


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

Posted on by cpatches


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

Posted on by aweinsoff@channelchek.com

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

Posted on by aweinsoff@channelchek.com

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