MustGrow Biologics Corp. (MGROF) – Growing Production


Wednesday, June 14, 2023

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , 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.

Completed Run. Yesterday, MustGrow filed a press release stating the Company successfully completed its initial commercial run-rate production of its mustard plant-based biocontrol liquid via a contract manufacturer. The run-rate of the production reached greater than 5,000 litres per day of the biocontrol liquid.

Revenue Translation. The production of the mustard plant-based biocontrol liquid technology is estimated to equal approximately USD$25 million of annual revenue at a retail level, along with creating zero residual waste through generating a high protein ingredient for animal feed. Based on the trial run, we believe the estimated annual production of the liquid would cover a fraction of the demand, and we estimate the trial run annual production liquid would cover some 25,000-50,000 acres.


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Release – ZyVersa Therapeutics Publishes New White Paper Detailing the Critical Role of Inflammasome ASC in Inflammatory Diseases, and Its Potential as a Therapeutic Target

Research News and Market Data on ZVSA

Jun 13, 2023

PDF Version

  • White paper summarizes the research of leading inflammasome experts, Drs. Helen Bramlett, Juan Pablo de Rivero Vaccari, W. Dalton Dietrich, and Robert W. Keane, University of Miami Miller School of Medicine
  • ASC, in monomeric form or as ASC specks, is central to initiation, amplification, and perpetuation of damaging inflammation leading to progressive tissue injury and chronic inflammatory diseases
  • The World Health Organization reports that chronic inflammatory diseases (heart disease, cancer, chronic respiratory disease, and diabetes) significantly threaten human health (led to death in over 33 million people worldwide in 2019)

WESTON, Fla., June 13, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with inflammatory and renal diseases who have significant unmet medical needs, announces availability of a new white paper on the critical role of inflammasome ASC in the development and progression of a wide-range of inflammatory diseases. Data suggest that drugs targeting ASC may provide the best opportunity to control damaging inflammation associated with diseases affecting millions of people worldwide. The white paper titled, “Inflammasome ASC: A Promising Therapeutic Target,” can be accessed by Clicking Here.  

The white paper highlights groundbreaking research from the labs of Drs. Bramlett, de Rivero Vaccari, Dietrich, and Keane, pioneers in the field of inflammasomes and members of ZyVersa’s Scientific Advisory Board. To read their biographies, Click Here.

“After 15 years of research to develop an understanding of how inflammasomes contribute to so many diverse diseases and conditions, we discovered the critical role of the ASC component and developed a monoclonal antibody, known as Inflammasome ASC Inhibitor IC 100,” stated Dr. Keane. “ASC is central to formation and activation of multiple inflammasome complexes associated with numerous diseases. ASC forms a large filamentous structure, the ASC speck, which is released from cells, amplifying and perpetuating inflammation. We believe that targeting ASC provides the best opportunity to control damaging inflammation.”

Dr. de Rivero Vaccari added, “We have studied IC 100 in animal models of diverse diseases and injuries including multiple sclerosis, age-related inflammation associated with neurodegenerative diseases, Alzheimer’s disease, acute respiratory distress syndrome, traumatic brain injury, and spinal cord injury. Each of these conditions demonstrated that IC 100 inhibited inflammasome activation, which resulted in improved histopathology and/or improved functional outcomes. We are continuing our research in other diseases, including Parkinson’s disease, for which we were awarded a grant from the Michael J. Fox Foundation.”

“ZyVersa, which obtained a worldwide license for Inflammasome ASC Inhibitor IC 100, is honored to collaborate with Drs. Bramlett, de Rivero Vaccari, Dietrich, and Keane to advance development of IC 100 into human trials,” said Stephen C. Glover, Co-founder, Chairman, CEO, and President of ZyVersa. “We have progressed manufacturing of IC 100 through GMP production, and our IND-enabling preclinical program has progressed through demonstration of IC 100 safety in dose-ranging toxicology studies in mice and monkeys.”

Mr. Glover continued, “We expect to complete the preclinical program for IC 100 by year’s end, and file an IND to initiate a Phase 1 trial in early 2024. We are excited about our progress, as we believe Inflammasome ASC Inhibitor IC 100 has potential to transform treatment of debilitating inflammatory diseases.”

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 attenuates both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:

Karen Cashmere
Chief Commercial Officer
[email protected]
786-251-9641        

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
[email protected]
646-577-8520

Dave Schemelia
[email protected]
609-468-9325

Release – MustGrow Completes Initial Commercial Production Run via Contract Manufacturer

  • Succesful completion of initial commercial run-rate production via third-party contract manufacturer.
  • Production run-rate of the extract reached greater than the equivalent of 5,000 litres per day of MustGrow’s mustard plant-based biocontrol liquid technology.
  • Estimated equivalent annual capacity equates to approximately US$25 million in grower level revenue without the need to construct capital intensive production facilities.

SASKATOON, Saskatchewan, Canada, Jun. 13, 2023 – MustGrow Biologics Corp. (TSXV: MGRO) (OTC: MGROF) (FRA: 0C0) (the “Company” or “MustGrow”), is pleased to announce the successful initial commercial run-rate production of its mustard plant-based biocontrol liquid via a contract manufacturer.

MustGrow believes this production milestone further validates the Company’s commercialization strategy to initially utilize a third party contract manufacturer rather than construct its own capital-intensive pilot and/or commercial production facilities. The continuous production run-rate of the extract reached greater than the equivalent of 5,000 litres per day of MustGrow’s mustard plant-based biocontrol liquid technology, which is estimated to equal approximately US$25 million in annual grower level revenue. The production process created zero residual waste by generating a high protein byproduct ingredient for animal feed.

MustGrow’s CEO, Corey Giasson noted: “This is a key transition for MustGrow, now able to complete our first commercial-level production without needing to build our own capital-intensive facility.  We are now confident that we will be capable of producing commercially-scalable quantities of TerraSanteTM and TerraMGTM in preparation for initial registration approvals.  The continuous-flow design process ran without any reported upsets and we are close to maximum theoretical recovery of our targeted mustard extracts in the concentrate. This milestone successfully demonstrates a low-risk continuous-flow process, while further mitigating commercialization risk.”

Utilizing a third party contract manufacturer markedly derisks commercial capabilities in MustGrow’s soil amendment and biofertility technologies, as well as biocontrol and postharvest food preservation, which are currently under development with four global partners: Janssen PMP, Bayer, Sumitomo Corporation, and NexusBioAg.

———

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world.  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.  Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertily markets.  Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements.  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, to soil amendment and biofertility.  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
[email protected]

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) estimated grower level revenue; (ii) the ability of the Company to produce commercially-scalable quantities of TerraSanteTM and TerraMGTM; (iii) risk levels associated with the continuous flow process; (iv) the continued success of its commercialization strategey including the commercial run-rate production of its mustard plant-based biocontrol liquid via a contract manufacturer; and (v) the maximum theoretical recovery of targeted mustard extracts in the concentrate.

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, 2022 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 TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2023 MustGrow Biologics Corp. All rights reserved.

Release – Ocugen, Inc. Announces Adjournment Of Annual Meeting Of Shareholders

Research News and Market Data on OCGN

June 9, 2023

MALVERN, Pa., June 09, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the Company’s 2023 Annual Meeting of Shareholders (Annual Meeting) was convened and adjourned, without any business being conducted, due to lack of the required quorum.

A quorum consists of the presence at the Annual Meeting either online during the live audio webcast or represented by proxy of the holders of a majority of the voting power of our outstanding shares of common stock entitled to vote at the Annual Meeting. There were fewer than a majority of shares entitled to vote present, either in person or by proxy at the Annual Meeting. The Annual Meeting therefore had no quorum, and accordingly, the Annual Meeting has been adjourned. The Annual Meeting will resume with respect to all proposals at 11 a.m. Eastern Time on Friday, June 23, 2023 and will continue to be held virtually.

The record date for determining shareholders eligible to vote at the Annual Meeting will remain the close of business on April 13, 2023. Shareholders who have already submitted a proxy do not need to vote again for the reconvened Annual Meeting, as the proxies submitted will remain valid. Shareholders who have already submitted proxies and would like to change their vote with respect to any of the proposals can update their vote in the manner set forth in the Definitive Proxy Statement. Your vote will be recorded at the Annual Meeting in accordance with your most recently submitted proxy.

Ocugen shareholders as of close of business on the April 13, 2023 record date who have not yet voted are encouraged to vote online at www.proxyvote.com or by telephone at 1-800-690-6903. Shareholders that need assistance voting or have questions, may contact Ocugen’s proxy solicitation firm, Innisfree M&A Incorporated, at (877) 750-8198.

Voting on all proposals will be open until the conclusion of Ocugen’s 2023 Annual Meeting on June 23, 2023.

If you hold your shares of our common stock with a broker, bank, or other holder of record as nominee or agent, you may be subject to an earlier voting deadline and you should carefully review any materials received from the nominee or agent regarding how to vote your shares.

A copy of the Definitive Proxy Statement is available to shareholders on the Company’s website and at the website maintained by the SEC at www.sec.gov.

Ocugen shareholders as of the April 13, 2023 record date for the Annual Meeting are invited to attend the virtual Annual Meeting by visiting www.virtualshareholdermeeting.com/OCGN2023.

Important Information

This material may be deemed to be solicitation material in respect of the Annual Meeting to be reconvened and held on June 23, 2023. In connection with the Annual Meeting, the Company filed a Definitive Proxy Statement with the SEC on April 20, 2023. BEFORE MAKING ANY VOTING DECISIONS, SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE ANNUAL MEETING. The Definitive Proxy Statement was mailed to shareholders who are entitled to vote at the Annual Meeting. No changes have been made to the proposals to be voted on by shareholders at the Annual Meeting. The Company’s Definitive Proxy Statement and any other materials filed by the Company with the SEC can be obtained free of charge at the SEC’s website at www.sec.gov or the Company’s website www.ocugen.com.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, 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 Corporate Communications
[email protected] 

Biotech Companies to Benefit from AI Efficiencies and Analysis

Enabling Better Drug Discovery Outcomes with Machine Learning

Can the long road to bring new medical treatments or therapies to market be shortened by introducing artificial intelligence? AI applied to the early stage of the discovery process, which often involves new insight into a disease or treatment mechanism, may soon provide researchers many more potential candidates or designs to evaluate. AI can also help in the sorting and evaluation of these candidates to improve the success rates of those that make it into the lab for further study.

Benefits AI Brings to Biotech Research

The cost of bringing a single drug to market in terms of time and money is substantial. Estimates are in the $2.8 billion range, and the average timeline for drug development exceeds a decade. On top of this, there is a low level of certainty of taking a promising molecule all the way to market. The success rate of translating preclinical research findings into effective clinical treatments is low; failure rates are estimated to be around 90%.

The refinement of digital sorting and calculating with advanced computational technologies, such as artificial intelligence (AI) and machine learning (ML), have the potential to revolutionize pharmaceutical research and development (R&D). Despite it still being a young technology, AI-enabled applications and algorithms are already making an impact in drug discovery and development processes.

One of the significant benefits of ML in drug development is its ability to recognize patterns and unveil insights that might be missed by conventional data analysis or take substantially less time to recognize. AI, and ML technologies can help a biotech company do precursory evaluation, accelerate the design and testing of molecules, streamline the testing processes, and provide a faster understanding along the way if the molecule will perform as expected. With improved clinical success and reduced costs throughout the development pipeline, AI may be shot in the arm the industry needs.

Adoption of AI in Biotechnology

While any full-scale adoption of AI in the pharmaceutical industry is still evolving and finding its place, implementation and investment are growing. Top global pharmaceutical companies have increased their R&D investment in AI by nearly 25% over the past three years – this indicates a recognition of the perceived benefits.

The interest and investment in AI drug discovery is fueled by several factors. As touched on earlier, a more efficient and cost-effective drug development process would be of great benefit. AI can significantly reduce both time and cost. And the sooner more effective treatments are available, the better. Chronic diseases, such as cancer, autoimmune problems, neurological disorders, and cardiovascular diseases, creates an ongoing demand for improved drugs and therapies. AI’s ability to analyze vast amounts of data, identify patterns, and then learn from the information at an accelerated rate can allow researchers to shorten timelines to final conclusions.  

Even more exciting is the growing availability of large datasets thanks to the rise of big data. With an increase in the volume, variety and velocity of data, and the AI-assisted ability to make sense of it, outcomes are expected to be improved. These datasets, obtained from various sources like electronic medical records and genomic databases, allow successful AI applications in drug discovery. Technological advancements, especially in ML algorithms, have been contributing to the growth of AI in medicine. And they are growing more sophisticated, allowing for accurate pattern identification in complex biological systems. Collaborations between academia, industry, and government agencies have further accelerated growth sharing knowledge and resources.

Trends in AI and ML Biotechnology

While considered a young technological field, AI-enabled drug discovery is being shaped by a number of new trends and technologies. Modern AI algorithms are now capable of analyzing intricate biological systems and foretelling the effects of medications on human cells and tissues. By detecting probable adverse effects early on in the development phase, the predictive ability helps prevent failures in the later stages.

By generating candidates that fit certain requirements, generative models can accelerate the design of completely new medications. But other technology is also now available to assist. By offering scalable processing resources, cloud computing dramatically cuts down on both time and expense. By simulating the interaction of hundreds of chemicals with disease targets, virtual drug screening enables the fast screening of drugs.

A higher understanding of disease biology and the discovery of new therapeutic targets is being made possible by integrative techniques that incorporate many data sources not available a short while ago.

Constraints on AI-Assisted Biotech Research

While AI can speed up certain aspects of drug discovery, it cannot replace most traditional lab testing. Hands-on experimentation and data collection on living organisms are expected to always be necessary, many of these processes during the clinical trial stages cannot be sped up.

Regulatory bodies, like the FDA, are also cautious about embracing AI fully, raising concerns about transparency and accountability in decision-making processes.

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Take Away

The near future of artificial intelligence and machine learning assuming a larger role in enabling drug discovery and more efficient R&D looks bright. The technology offers real promise for more efficient and cost-effective drug development processes – this would address the need for new therapies for chronic diseases.

The time-consuming process of testing on real subjects is not expected to be replaced or overly streamlined by technology, but finding subjects and evaluating results can also benefit from the new technology.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://5058440.fs1.hubspotusercontent-na1.net/hubfs/5058440/cold%20outreach%20use%20case%20images/Pathways%20for%20Successful%20AI%20Adoption%20in%20Drug%20Development%20-%20VeriSIM%20Life.pdf

https://www.mckinsey.com/industries/life-sciences/our-insights/ai-in-biopharma-research-a-time-to-focus-and-scale

https://www.drugdiscoveryonline.com/doc/the-global-market-for-ai-in-drug-discovery-to-sextuple-by-0001

https://www.mckinsey.com/industries/life-sciences/our-insights/we-can-invent-new-biology-molly-gibson-on-the-power-of-ai

https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process

Baudax Bio (BXRX) – More Positive Top-Line Results From Phase II BX1000 Trial


Thursday, June 08, 2023

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

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

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

Deeper dive into the results.  The electomyography (EMG) detailed analysis confirmed the earlier top-line data released showing the highest dose of BX1000 was comparable to rocuronium (current standard). There was a clear dose response for BX1000 on maximum T1 suppression, with comparable results for the 1.5x ED95  dose of BX1000 and the 2x ED95 dose of rocuronium, strongly suggesting lower BX1000 dosing needed.

What is T1 suppression?  Train of Four (TOF) testing is a method of peripheral nerve stimulation, using electrodes placed along the nerve pathway. An electrical impulse will cause a contraction (twitch). With increased NMB dosing, the twitch response fades, with the fourth (T4) response lost first, then T3, then T2, and finally the first (T1). The number of twitches observed indicates the NMB level achieved, determining the minimum amount needed to achieve the desired effect, while reducing the likelihood of over-paralysis and prolonged muscle weakness. A T1 level of suppression (or one twitch) represents approximately 90% block, a level suitable for short term procedures including intubation. 


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Release – Tonix Pharmaceuticals Announces Data Presentations Involving TNX-1500 (anti-CD40L mAb) for the Prevention of Rejection in Kidney and Heart Allograft Transplantation in Animal Models at the 2023 American Transplant Congress

Research News and Market Data on TNXP

June 07, 2023 7:00am EDT

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital

TNX-1500 is Expected to Enter Phase 1 Clinical Development in Third Quarter 2023

CHATHAM, N.J, June 07, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced data from two oral presentations and one poster presentation at the 2023 American Transplant Congress (ATC) by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital. The data involve studies of Tonix’s TNX-1500 (Fc-modified anti-CD40L monoclonal antibody) in development for the prevention of organ transplant rejection. The molecular target of TNX-1500 is CD40-ligand (CD40L), which is also known as CD154. Copies of the presentations are available on the Tonix Pharmaceuticals website at www.tonixpharma.com.

The oral presentations titled, “Fc-Modified anti-CD154 Mab Induced Long Term Renal Allograft Survival without Thromboembolic Complications” by Dr. Ryo Otsuka et al. and “Efficacy of CD154 Blockade with TNX-1500 to prevent heart allograft immune injury” by Dr. Ikechukwu Ileka et al., and the poster presentation titled “anti-CD154 mAb (TNX-1500) Alone, or in Combination with Rapamycin, MMF, or anti-CD28 mAb (VEL-101) Prolongs Cynomolgus Cardiac Allograft Survival” by Dr. Kohei Kinoshita et al. include data demonstrating that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. Blockade of CD40L with TNX-1500 monotherapy consistently prevented pathologic alloimmunity in non-human primate kidney and cardiac allograft models without clinical thrombosis. Dr. Kinoshita was recognized with “Poster of Distinction” for his poster presentation.

“The animal studies found that TNX-1500 retains activity to prevent rejection and preserve graft function, which we believe provides strong rationale for us to pursue development of TNX-1500 to prevent rejection in human transplant,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We expect to begin a Phase 1 trial with TNX-1500 in the third quarter of 2023. There remains a significant need for new treatments with improved activity and tolerability to prevent organ transplant rejection. TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. We believe TNX-1500 has the potential for treating and preventing organ transplant rejection. Beyond transplantation, we believe TNX-1500 has potential for treating autoimmune conditions including systemic lupus erythematosus, Sjögren’s syndrome and multiple sclerosis.”

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the first quarter of 2024. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

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

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
[email protected]
(212) 845-4273

Peter Vozzo (investors)
Westwicke/ICR
[email protected]
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released June 7, 2023

PDS Biotechnology Corp. (PDSB) – Phase 2 VERSATILE-002 Data Reviewed On Conference Call


Wednesday, June 07, 2023

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, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

ASCO Presentation On Head and Neck Cancer Reviewed. PDS Biotechnology held a conference call to review data from the Phase 2 VERSATILE-002 trial that was presented at the annual ASCO meeting on Monday, June 5. Management also briefly commented on a misinterpretation posted on social media sites that caused a sharp price decline and a trading halt in the stock.

VERSATILE-002 Data Consistent With Previous Results. As discussed in our Research Note from May 30, the presentation updated the Phase 2 VERSATILE trial data presented at ASCO ’22. At that time, preliminary data from the first 17 patients to reach the 9-month evaluation post was presented. The update included data from 34 patients that had reached the 12-month evaluation point. 


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

ChitogenX Inc. (CHNXF) – Non-Brokered Private Placement 2nd Tranche Closed; Clarification And Revision


Wednesday, June 07, 2023

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

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

2nd Tranche.  The Company announced Monday they had closed a 2nd tranche for $288,000 (currencies in Canadian $).  This tranche, on the back of the closed $3.86 million 1st tranche announced previously, consisted of gross cash proceeds of $41,250 and $241,141 in convertible debt conversions that had matured May 1, 2023.  In this 2nd tranche, 1.922608 million units at $0.15 per unit were issued.  Each unit consisted of one share of common and one purchase warrant exercisable at $0.35 per share.

Clarification To Company May 5, 2023 Press Release And Correction.  In the Company’s press release Monday June 5, 2023, it was clarified that the $3.86 million non-brokered 1st tranche placement, which closed early May, consisted of $1.267 million in gross cash proceeds and debt conversions of $2.589 million.  While the two tranches remove $2.84 million in liabilities, gross cash proceeds from the tranches totaled approximately $1.31 million. In our prior noted dated June 1, 2023, we indicated ChitogenX raised $5.3 million subsequent to its fiscal January 31, 2023 yearend. However, gross cash proceeds were approximately $3.0 million.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Can an Inexpensive, Repurposed Therapy Treat Brain Cancer?

Brain Tumors are Cognitive Parasites – How Brain Cancer Hijacks Neural Circuits and Causes Cognitive Decline

Researchers have long known that brain tumors, specifically a type of tumor called a glioma, can affect a person’s cognitive and physical function. Patients with glioblastoma, the most fatal type of brain tumor in adults, experience an especially drastic decline in quality of life. Glioblastomas are thought to impair normal brain functions by compressing and causing healthy tissue to swell, or competing with them for blood supply.

What exactly causes cognitive decline in brain tumor patients is still unknown. In our recently published research, we found that tumors can not only remodel neural circuits, but that brain activity itself can fuel tumor growth.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of, Saritha Krishna, Postdoctoral Fellow in Neurological Surgery, University of California, San Francisco, and Shawn Hervey-Jumper, Associate Professor of Neurological Surgery, University of California, San Francisco.

We are a neuroscientist and neurosurgeon team at the University of California, San Francisco. Our work focuses on understanding how brain tumors remodel neuronal circuits and how these changes affect language, motor and cognitive function. We discovered a previously unknown mechanism brain tumors use to hijack and modify brain circuitry that causes cognitive decline in patients with glioma.

Brain Tumors in Dialogue with Surrounding Cells

When we started this study, scientists had recently found that a self-perpetuating positive feedback loop powers brain tumors. The cycle begins when cancer cells produce substances that can act as neurotransmitters, proteins that help neurons communicate with each other. This surplus of neurotransmitters triggers neurons to become hyperactive and secrete chemicals that stimulate and accelerate the proliferation and growth of the cancer cells.

We wondered how this feedback loop affects the behavior and cognition of people with brain cancer. To study how glioblastomas engage with neuronal circuits in the human brain, we recorded the real-time brain activity of patients with gliomas as they were shown pictures of common objects or animals and asked to name what they depicted while they were undergoing brain surgery to remove the tumor.

While the patients engaged in these tasks, the language networks in their brains were activated as expected. However, we found that the brain regions the tumors had infiltrated quite remote from known language zones of the brain were also activated during these tasks. This unexpected finding shows that tumors can hijack and restructure connections in the brain tissue surrounding them and increase their activity.

This may account for the cognitive decline frequently associated with the progression of gliomas. However, by directly recording the electrical activity of the brain using electrocorticography, we showed that despite being hyperactive, these remote brain regions had significantly reduced computational power. This was especially the case for processing more complex, less commonly used words, such as “rooster,” in comparison with simple, more commonly used words, such as “car.” This meant that brain cells entangled in the tumor are so compromised that they need to recruit additional cells to carry out tasks previously controlled by a smaller defined area.

We make an analogy to an orchestra. The musicians need to play in synchrony for the music to work. When you lose the cellos and the woodwinds, the remaining musicians can’t deliver the piece as effectively as when all players are present. Similarly, when brain tumors hijack the areas surrounding it, the brain is less able to effectively function.

Gabapentin as a Promising Drug for Glioblastoma

Now we understood that tumors can impair cognition by affecting neural connections. Next, we further examined their connections with each other and with healthy neurons using mouse models and brain organoids, which are clusters of brain cells grown in a Petri dish.

These experiments, led by one of us, Saritha Krishna, found that tumor cells secrete a protein called thrombospondin-1 that plays a key role in promoting the hyperactivity of brain cells. We wondered whether blocking this protein, which normally helps neurons form synapses, would halt tumor growth and extend the survival of mice with glioblastoma.

Glioma cells could potentially be treated by repurposing the anti-seizure drug gabapentin. Castro Lab, Michigan Medicine/NIH via Flickr, CC BY-NC

To test this hypothesis, we treated mice with a common anti-seizure drug called gabapentin that blocks thrombospondin-1. We found that gabapentin was able to keep the brain tumors from expanding for several months. These findings highlight the potential of repurposing this existing drug to control brain tumor growth.

Our study suggests that targeting the communication between healthy brain cells and cancer cells could offer another way to treat brain cancer. Combining gabapentin with other conventional therapies could complement existing treatments, helping mitigate cognitive decline and potentially improving survival. We are now exploring new ways to take advantage of this drug’s potential to halt tumor growth. Our goal is to ultimately translate the findings of our study to clinical trials in people.

MustGrow Biologics Corp. (MGROF) – Setting Up the Seeds to Sprout


Tuesday, June 06, 2023

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , 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.

New Agreement. MustGrow announced the Company has agreed to a Contract Services Agreement with Bio Ag Product Strategies to develop and commercialize MustGrow’s soil amendment and biofertility technologies, including TerraSante. The agreement is a non-exclusive contract, enabling MustGrow to seek out additional commercial collaborations and funding partnerships. Neither the length of the agreement nor any financials were disclosed.

Who is Bio Ag? Bio Ag Product Strategies is a consulting firm that provides consultation to manufacturers of microbial products for agriculture and support products including biostimulants and prebiotics. According to MustGrow, Bio Ag Product Strategies has tremendous knowledge and a great track record of working with organizations to help develop, market, and target key retailers and farmers.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

An Investor List of the Industries that Can be Improved With Blockchain Technology

Blockchain Beyond Cryptocurrency: The Potential of Distributed Ledger Technology

Does blockchain have a future beyond crypto? Since its beginning as the underlying technology for Bitcoin (BTC) and later other cryptocurrencies, blockchain has been the necessary, behind-the-scenes, engine that allow these fintech currencies to function. Dogecoin (DOGE), Ethereum (ETH), and even the 18 G20 countries developing a central bank digital currency (CBDC) need blockchain to exist.  

But what non-finance industries are being impacted or will be disrupted by blockchain? It is not with exaggeration to say blockchain has the power to revolutionize various industries and redefine everyday transactions, manage data, and establish trust. Long-term investing requires knowledge of current trends and where the future may take them. Below we explore many of the possibilities of blockchain aside from cryptocurrency and delve into its promising future.

What is Blockchain?

At its core, blockchain is a decentralized (no single control) and immutable (unable to be changed) ledger that records activity across multiple computers. This distributed character replaces the need for institutional intermediaries to ensure transparency, security, and efficiency. A person or an entity can function, even across borders directly, without the need for a middleman. Verification of activity is recorded and remains a part of a blockchain ledger.

Uses beyond cryptocurrency, or the speculative investment that crypto and non-fungible tokens (NFT) have become, include health care, finance, voting, real estate titles, and smart communities.

Health Care

The HIPAA Privacy Rule sets national standards to protect individuals’ medical records and other identifiable health information. It applies to health plans, healthcare clearinghouses, and healthcare providers that conduct certain medical transactions electronically. The purpose is to keep data ownership from improperly being passed and to maintain privacy in the industry. Current centralized systems are not able to meet the many needs of patients, health service providers, insurance companies, and governmental agencies. Blockchain technology enables a decentralized system for access control of medical records where all stakeholders’ interests are protected.

Blockchain systems not only allow healthcare service providers to securely share patients’ medical records but patients may also track who has accessed their records and determine who is authorized to do so. If blockchain-driven, all transactions can become transparent to the patient.

And blockchain-powered interoperability can enable the seamless sharing of medical data between healthcare organizations, improving patient care, research, and drug development.

Supply Chain Management

Complex global supply chains involve numerous stakeholders, some sending, others receiving, and others verifying the source of food or products. Verifying the authenticity and improving traceability of products can be a challenging task. Blockchain’s ability to create an immutable record of every transaction and movement along the supply chain enables transparency and accountability. A company will be able to securely track the origin, manufacturing process, and movement of goods. Consumers can be equipped with verified information, among other benefits, this will increase trust and reduce the risk of receiving counterfeit products.

Storing information regarding movement on a blockchain improves integrity, accountability and traceability. For example, IBM’s Food Trust uses a blockchain system to track food items from the field to retailers. The participants in the food supply chain record transactions in the shared blockchain, which simplifies keeping track.

Entertainment Products

As technology has allowed greater reproduction and distribution, including music and art, blockchain may provide creators with more control over their work. The whole entertainment industry may undergo a significant transformation with blockchain technology. Artists can tokenize their efforts, creating a digital certificate of ownership that can be bought, sold, and shared on blockchain platforms. This will enable artists to have tight control over their intellectual property, receive fair compensation, and even establish a direct connection with their followers. Beyond ownership infringement, blockchain can facilitate transparent royalty distribution, this could ensure that artists receive their rightful earnings without an intermediary and the cost that comes with anyone getting in the middle of a transaction.

The Energy Sector

Blockchain is likely to play a transformative role in all forms of energy. As renewable energy sources continue their trend, blockchain can enable peer-to-peer energy trading. Individuals and organizations will be able to directly exchange surplus energy with those expecting an energy deficit. This could create a decentralized energy market.

Smart contracts executed on the blockchain can automatically verify and settle transactions, ensuring transparency. This democratization of energy, if broadly implemented, could accelerate the adoption of sustainable practices, provide energy where needed, and reduce waste.

Governments

While the government is often the intermediary that the blockchain makes less needed or unneeded, recognizing the potential of blockchain to enhance transparency and efficiency in public services may become its greatest use. Land registries, taxation, voting systems, and identity certainty can all be improved through blockchain’s tracking and tamper-resistant design. Immutable records of land ownership can reduce disputes and increase trust in property transactions. Digital identities stored on a blockchain can streamline processes such as passport verification and border control, making them more secure and efficient. Blockchain-based voting systems have the potential to eliminate voter fraud, ensuring fair and transparent elections.

Potential

Much of what is described above has either barely been implemented or has not been put to use. This is a period in any technological advancement when most long-term investors would like to be involved. Efficiencies and improved products are poised to help the industries mentioned, and pure blockchain companies, large and small, can benefit from developing uses for their technology.

Despite its potential, blockchain technology still faces challenges. Scalability, energy consumption, and regulatory frameworks require further development and refinement. However, ongoing research and collaborations among businesses, academia, industry, and policymakers are actively finding avenues around these concerns, driving the maturation of blockchain technology.

Take Away

Blockchain is still in its infancy, and industries are just becoming aware of its power to help them. As the paradigm shifts, it could become a technology businesses could not imagine doing without. Blockchain’s decentralized, transparent, and secure nature makes it a powerful tool for revolutionizing healthcare, supply chain management, entertainment, governing, and energy sectors. As the technology evolves, we can expect innovative use and widespread adoption of blockchain that serves to elevate trust, efficiency, and transparency. And maybe the now-developed cryptocurrencies will survive within these changes.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.investopedia.com/tech/forget-bitcoin-blockchain-future/

https://www.hhs.gov/hipaa/for-professionals/privacy/index.html

https://www.ibm.com/products/supply-chain-intelligence-suite/food-trust

https://www.investopedia.com/10-biggest-blockchain-companies-5213784

Release – PDS Biotechnology Post-ASCO Conference Call Tomorrow, June 6, at 8 a.m. ET

Research News and Market Data on PDSB

FLORHAM PARK, N.J., June 05, 2023 (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 that the Company will be hosting a conference call and webcast tomorrow, June 6, 2023, to discuss the promising interim data from the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), presented at the 2023 American Society for Clinical Oncology (ASCO) meeting.

During the call, management will provide an in-depth review of the 2023 ASCO interim data.

Conference Call Information:
PDS Biotech will host a conference call on Tuesday, June 6, at 8:00 a.m. ET to discuss the interim data being presented at the ASCO 2023 Annual Meeting. A live webcast of the event will be available online at PDS Biotech Post-ASCO Webcast. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

Additionally, interested participants and investors may access the conference call by dialing either 877-407-3088 (US) or 201-389-0927 (International).

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®, Versamune® plus PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. 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. 

Investor Relations:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

Media Contacts:
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
[email protected]

Bill Borden
Phone: +1 (732) 910-1620
[email protected]