Category: Health

Release – MustGrow and Bio Ag Product Strategies Sign Agreement to Develop and Commercialize Soil Amendment & Biofertility Technologies

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MGROF

  • Mustard plant-based development programs to focus on soil and microbiome health, nutrient and water use efficiencies, and plant yields.
  • Initial focus in Washington, Oregon, California, Arizona, then U.S. nationwide.

SASKATOON, Saskatchewan, Canada, Jun. 5, 2023 – MustGrow Biologics Corp. (TSXV: MGRO) (OTC: MGROF) (FRA: 0C0) (the “Company” or “MustGrow”), is pleased to announce the signing of a Contract Services Agreement (the “Agreement”) with Oregon-based Bio Ag Product Strategies to develop and commercialize MustGrow’s soil amendment and biofertility technologies, including TerraSanteTM. The Agreement is a non-exclusive contract, leaving MustGrow the ability to seek commercial collaborations and funding partnerships.

MustGrow recently outlined its soil amendment (“Soil Amendment”) and biofertility (“Biofertility”) development programs, and working with Bio Ag Product Strategies to develop and commercialize these technologies demonstrates the Company’s positive progression in those areas.  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.  MustGrow’s Soil Amendment and Biofertility development programs will focus on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields.  Initially, the development work is anticipated to progress in Washington, Oregon, California and Arizona, before expanding nationwide across the United States.

“I am very excited to work with MustGrow to help develop and commercialize their technologies in Soil Amendmnent and Biofertilizers”, commented Bio Ag Product Strategies owner, Tim Lichatowich.  “Our industry needs new innovations that can support food production in both conventional and organic agriculture and I believe that MustGrow’s technologies can add a lot of value.  The main fruit and vegetable regions of the U.S. are under constant pressure to ban and/or reduce the use of synthetic products, and being able to work with a natural product is promising for commercial-scale adoption.”

Throughout 2022, MustGrow engaged in market research, formulation activities, and prospective partnership discussions, and has added Soil Amendment and Biofertility programs to its growing global intellectual property portfolio which now covers: preplant biocontrol, postharvest food preservation and now Soil Amendment and Biofertility applications.

MustGrow believes this Soil Amendment and Biofertility initiative will concurrently be developed alongside its other programs in biocontrol, which include preplant soil fumigation, postharvest food preservation, and bioherbicide, which are currently under development with four global partners: Janssen PMP, Bayer, Sumitomo Corporation, and NexusBioAg.

TerraSanteTM for Soil and Ecological Health

Soil is a farmer’s most valuable and precious asset, and MustGrow’s plant-based technologies are being developed to improve not only the health of the soil, but also the surrounding ecological environment.

As a soil conditioner in mixable form, TerraSanteTM contains nutritious plant proteins and carbohydrates that feed soil microbes, potentionally improving beneficial microbial activity and ensuring long-term sustainable soil health. These targeted micro-communities are shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress.  TerraSanteTM has the potential to improve crop nutrient uptake and, hence, overall crop performance.  There are no artificial additives or preservatives used during manufacturing.

MustGrow is initially pursuing TerraSanteTM branded registrations in North America for Soil Amendment applications, followed by formulations and brands targeting the Biofertility markets.  The Soil Amendment and Biofertility products will utilize multiple technologies derived from novel plant-based extracts from mustard and potentially other sources.

Soil Amendment and Biofertility Marketplace

The global fertilizer market is anticipated to reach US$242 billion by 2030, up from US$193 billion in 2021 (2.5% CAGR).(1)  This aggregate fertilizer figure includes the following sub-markets, which MustGrow intends to target with TerraSanteTM and potentially other branded products:

  • Soil Amendment: estimated market size in 2022 was US$3.5 billion and is expected to be US$8.0 billion by 2030 (11.0% CAGR).(2)
  • Biofertility: estimated market size in 2021 was US$2.7 billion and is estimated to be US$7.0 billion by 2030 (12.3% CAGR).(3)

Combined, these additional market segments have the potential to add over US$15 billion of target market opportunity globably for MustGrow by 2030, almost double from the initially targeted Biocontrol market

Alternatives to Synthetic Fertilizers are Needed

With the world’s population expanding, agriculture production and global food security are increasingly important. Fertilizers continue to play a critical role in agriculture, yet plans to reduce their use have been amplified in recent years to minimize the negative consequences of climate change through emission reduction strategies. Canada, for example, has set a voluntary national fertilizer emissions reduction target of 30% below 2020 levels by 2030 to lower greenhouse gas emissions.(2) Sustainable, climate-friendly solutions may play a role in helping to offset this reduction while balancing the nation’s economic health. For example, Canada’s fertilizer industry directly and indirectly supports over 76,000 jobs and contributes nearly C$13 billion to Canadian GDP.(2)

The European Green Deal is targeting a 20% reduction in fertilizer use by 2030, while also ensuring no deterioration in soil fertility, as part of the European Commission’s aim to reduce nutrient losses by at least 50% by 2030.(3) Fertilizer reduction is a key element of the broader Green Deal target of a minimum 55% net reduction in greenhouse gas emissions by 2030.(4)

Weighing fertilizer reduction targets versus the need to increase farm production, farm profitability, economic growth and global food security points to sustainable Soil Amendment and Biofertility innovation and development as one potential key agriculture solution.

Source:
1) Statista, Fortune Business, Polaris Market Research.
2) https://fertilizercanada.ca/our-focus/stewardship/emissions-reduction-initiative/
3) https://agriculture.ec.europa.eu/system/files/2022-02/factsheet-farmtofork-comparison-table_en_0.pdf
4) https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal_en

——-

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.  Concurrenly, with new formulations derived from food-grade mustard, the Compmany 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
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”, “will”, “would”, “might”, “occur” or “be achieved”.  Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: (i) the development and commercialization of MustGrow’s soil amendment, biofertility and biocontrol technologies; (ii) the expansion of MustGrow’s development work across the United States; (iii) commercial-scale adoption; (iv) the potential benefits and performance of TerraSanteTM; and (v) the global fertilizer market and sub-markets.

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 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.

More Proof There is Significant Value in Biotech Stocks

Posted on by phoffman@channelchek.com

Another Sign Conditions are Improving for Biotech Stocks

Biotech stocks seem to be exhibiting unusual value for any stock segment. A subset of the healthcare sector, biotechnology includes companies researching, and developing what may be the next-generation medical preventatives and treatments. There had been a huge decline in interest in the segment that coincided with FDA approval of the first Covid19 vaccine in late Summer 2021. Since then, the average price has been more than cut in half (see XBI/IBB chart) for biotechs.

The chart below is the S&P SPDR Biotech ETF and iShares Biotech ETF. They represent 280 stocks. According to an article in Barron’s dated June 4, 2023, of these, 23 (almost 10%) are trading below enterprise value (EV). Many more are on the cusp of trading right at the value of their net assets. For example, the article mentioned Atea Pharmaceuticals (AVIR), a biotech developing antiviral therapeutics for Hep-C and Covid. “If you bought all Atea’s shares and paid off all of its debt, the cash and other liquid assets remaining on its balance sheet would be worth more than what you spent,” wrote Barron’s.

Source: Koyfin

Of the 280 stocks, nearly 60 have enterprise values below $100 million – the current conditions are not sustainable. At some point, the “invisible hand” of the market is will work to correct it. Last week, Atea, which had been trading near $3.70 recently, was offered $5.75 per share. Concentra Biosciences, which is controlled by the investment fund Tang Capital Partners, made the offer with some contingencies tied to licenses or sales of Atea’s products.

The peculiar condition of the market valuing biotech companies below EV or even cash came to my attention at a RoadShow that was arranged by Noble Capital Markets that featured Cocrystal Pharma (COCP). Cocrystal has several products advancing toward clinical milestones. It was presented by a member of Cocrystals executive management team in South Florida. While the myself and the other investors became familiar with COCP’s development pipeline, and data like the rate of cash usage, the amount of cash on hand, and the market value, it became quite apparent the company had far more cash than the amount the stock market had priced the entire company. And at its cash burn rate (amount of cash used to cover expenses each month), that there might be a significant valuation disconnect.

Many believe disconnects like this will be resolved as the markets always are seeking value and seemingly mispriced companies. There are already many examples this in 2023 as big pharma either has partnered with, or outright acquired companies. This, of course, can cause the stock prices to skyrocket. In fact, while the news was focused on Silicon Valley Bank last March, Provention Bio (PRVB) shot up 258% after a deal was announced.

Smaller biotechs need money to spend on developing drugs, and can’t rely on product sales. Even with what might seem like a huge war-chest of cash, low market values have stifled the ability to raise new money. The road to the next wonder drug is long and requires management to take comfort that they can secure funds when needed.

The extent of this challenge is unique to each company. For many, since the biotech segment valuations came down from the pandemic-inspired dizzying heights,  they might have cash, but not enough to go an extended period until funding conditions improve. The offer last week by Concentra is a sign that conditions are changing. It isn’t just pharmaceutical companies shopping now for biotech bargains to own, it seems investment partnerships are also recognizing the extreme value in some companies.

For data and current information on almost 250 biotech companies, visit the biotech industry section here, on Channelchek.  

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.barrons.com/articles/biotechs-negative-enterprise-values-5e289e8e?mod=Searchresults

Schwazze (SHWZ) – A Succession Plan Finalized

Posted on by cpereira@noblefcm.com


Thursday, June 01, 2023

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.

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.

A New CEO. Yesterday, Schwazze announced the Company has promoted President Nirup Krishamurthy to the role of CEO, with former CEO Justin Dye continuing to lead the Board of Directors as its non-executive Chairman.

Part of the Plan. Mr. Krishamurthy has been part of a succession plan created nearly a year ago when Mr. Dye informed the Board of Directors of his desire to transition into a Chairman role. The appointment of Mr. Krishamurthy to be President in October of 2022 was part of Mr. Dye’s decision, as he handpicked Mr. Krishamurthy as his successor with support of the Board. As President, Mr. Krishamurthy steered the day-to-day operations and worked with Mr. Dye to successfully transition daily operations. We believe that Mr. Krishamurthy has the ability to continue what Mr. Dye has created.


Get the Full Report

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. 

MustGrow Biologics Corp. (MGROF) – 1Q23 Results

Posted on by cpereira@noblefcm.com


Thursday, June 01, 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.

Financial Results. Zero revenue and a loss of CAD$1.0 million, or a loss of $0.02/sh for 1Q23, similar to the 4Q22 loss. We had forecast revenue of CAD$1,000 and a net loss of CAD$924,066, or $0.02 per share. Until MustGrow receives regulatory approval in at least one market, we anticipate similar quarterly results going forward.

Janssen Re-Ups. Last week, Janssen PMP, a unit of Janssen Pharmaceuticals, signed an extension to test and develop MustGrow’s biological mustard plant-based technologies for certain postharvest food preservation storage applications globally. According to Janssen, “In post-harvest, the need for technologies derived from nature remains very high. Janssen PMP sees a great potential in the use of the MustGrow technology in extending shelf life of fruits and vegetables. This is the reason why we decided to extend our global exclusive partnership with MustGrow…” We believe such actions reflect positively on MustGrow and its products.


Get the Full Report

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) – FY2023 Ending January 31, 2023 Reported

Posted on by cpereira@noblefcm.com


Thursday, June 01, 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.

Reported Full Year Fiscal 2023.  Yesterday, ChitogenX reported a loss per share of $0.13 (currencies in Canadian $), versus our expected $0.12 loss per share.  The difference was primarily due to a $768,000 charge on converting the $3 million non-convertible debt into a convertible debenture, taken during the fourth quarter. Operationally, fourth quarter expenses were lower at $1.09 million versus our estimate of $1.29 million, with lower than estimated R&D costs the biggest factor. 

Subsequent News. At fiscal yearend, the Company reported $108,000 in cash and equivalents. Subsequent to the yearend, ChitogenX raised about $5.3 million giving the Company some runway to develop both orthopedic and non-orthopedic applications.  As a reminder, ChitogenX also secured a $3.47 million 4-year grant in February 2023 for regenerative medicine development and to accelerate the commercial readiness of the ORTHO-R platform.


Get the Full Report

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. 

Release – Multi-State Cannabis Operator, Schwazze, Promotes Nirup Krishnamurthy to Chief Executive Officer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

May 31, 2023

NEO: SHWZ 
OTCQX: SHWZ

DENVER, May 31, 2023 /CNW/ – Medicine Man Technologies, Inc., operating as Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), is pleased to announce the promotion of its President, Nirup Krishnamurthy, to the role of Chief Executive Officer. Justin Dye – the company’s former Chief Executive Officer and Executive Chairman – will continue to lead the Board of Directors (the “Board”) as its non-executive Chairman. 

   

This appointment is part of a succession planning process that began nearly a year ago when Justin Dye, the CEO and Executive Chairman, informed the Board of his desire to transition into a Chairman role. Nirup was handpicked by Justin as his successor with the full support of the Company’s Board and was promoted to President of Schwazze in October of 2022 to enable the transition. Over the past eight months, Justin has worked with Nirup to successfully transition daily operations. As President, Nirup has been steering the Company’s day-to-day operations, spearheading the Colorado and New Mexico growth initiatives, driving efficiencies to further enhance margins, and bolstering the Schwazze team.

Nirup joined Schwazze in 2020 when there were less than 20 employees and has played a pivotal role in helping to build the Company to the leading player in its region with $170mm of revenue, $59 million of EBITDA, and over 725 employees today. He brings more than 30 years of experience in operations, M&A, innovation, and technology at Fortune 500 companies. Nirup previously held C-level transformational roles with United Airlines, Northern Trust Bank, and the national grocery retailer A&P. He holds a bachelor’s degree in mechanical engineering and a doctorate in Industrial Engineering from State University of New York, Buffalo.  

Justin Dye, Chairman stated: “I am very pleased to announce Nirup’s appointment as the Chief Executive Officer 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 result in our continued growth. On behalf of Schwazze’s Board of Directors, we look forward to supporting Nirup and the team in our drive to become the most admired cannabis company in the industry. I also plan to do everything I can as non-executive Chairman of the Board of Directors to maximize shareholder value at Schwazze.”

“Over the past four years, Justin’s vision and leadership has transformed Schwazze into one of the best cannabis operators in the industry. His passion for the business has motivated me and the management team to thrive under tough conditions. In my capacity as CEO, I look forward to leading and supporting the Schwazze team members as they strive to deliver value to our customers, employees, and shareholders”, said Nirup Krishnamurthy, CEO. “Our strategic vision will continue to center around going deep in our current markets of Colorado and New Mexico, while exploring the potential to add a small number of select markets in the future. High-quality product assortment coupled with great customer service will remain the foundation of our retail philosophy, and we will continue to invest in our own house of brands and pursue responsible M&A.”

Since April 2020, Schwazze has acquired, opened, or announced the planned acquisition of 60 cannabis retail dispensaries (bannered as Star Buds, Emerald Fields, R. Greenleaf, Standing Akimbo, and Everest) as well as eight cultivation facilities and three manufacturing plants across Colorado and New Mexico. In May 2021, Schwazze launched its Biosciences division, and in August 2021 it commenced home delivery services in Colorado.

About Schwazze

Schwazze (OTCQX: SHWZ) (NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition.

Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit www.Schwazze.com.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intends,” “plans,” “strategy,” “prospects,” “anticipate,” “believe,” “approximately,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” or the negative of these terms or other words of similar meaning in connection with a discussion of future events or future operating or financial performance, although the absence of these words does not necessarily mean that a statement is not forward-looking. 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) regulatory limitations on our products and services and the uncertainty in the application of federal, state, and local laws to our business, and any changes in such laws; (ii) our ability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (iii) our ability to identify, consummate, and integrate anticipated acquisitions; (iv) general industry and economic conditions; (v) our ability to access adequate capital upon terms and conditions that are acceptable to us; (vi) our ability to pay interest and principal on outstanding debt when due; (vii) volatility in credit and market conditions; (viii) the loss of one or more key executives or other key employees; and (ix) other risks and uncertainties related to the cannabis market and our business strategy. 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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/multi-state-cannabis-operator-schwazze-promotes-nirup-krishnamurthy-to-chief-executive-officer-301839168.html

SOURCE Medicine Man Technologies, Inc.

Release – GeoVax Partners with ABL to Advance cGMP Production of Vaccine Candidates

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

Atlanta, GA, May 31, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced it has executed a Master Services Agreement (MSA) with Advanced Bioscience Laboratories, Inc. (ABL) to support current Good Manufacturing Practices (cGMP) production of the company’s vaccine candidates, including GEO-MVA and GEO-CM04S1.

ABL, a subsidiary of Institut Mérieux, is a pure-play contract development and manufacturing organization (CDMO) specialized in development and manufacturing of gene therapies, oncolytic viruses and vaccine candidates. With cGMP facilities located in the U.S. and Europe, ABL is well-positioned to support GeoVax’s global development programs.

David Dodd, GeoVax’s Chairman and CEO, commented “In choosing to collaborate with ABL to support the cGMP manufacturing of our multiple vaccine candidates, we have selected a partner with a strong technical and regulatory track record in process development, scale-up and GMP manufacturing of oncolytic and immunotherapeutic viral vectors. We believe ABL, as a manufacturing partner, is highly capable of assisting us in advancing our innovative product candidates, including GEO-CM04S1 and GEO-MVA, through late-stage development and towards eventual commercialization.”

About GEO-CM04S1

GEO-CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to protect against the new and continually emerging variants of COVID-19. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating.

A recent presentation of unpublished data from the open-label portion of the Phase 2 trial of CM04S1 (ClinicalTrials.gov Identifier: NCT04977024) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment) indicates that CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines.

CM04S1 continues to advance in a second Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466). Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.

About GEO-MVA

In response to the global need to address the continued emerging threat from Mpox, GeoVax previously announced having secured rights from the National Institutes of Health (NIH) covering preclinical, clinical and commercial uses of the NIH-MVA as a vaccine against Mpox or smallpox. The company is currently pursuing different regulatory pathways toward achievement of an expedited approval.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a COVID-19 vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient. In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “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 and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. 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 Relations Contact:

Rich Cockrell

CG Capital

404-736-3838

govx@cg.capital

Release – Cocrystal Pharma Receives HREC Approval to Initiate Phase 1 Study to Evaluate Oral Broad-Spectrum Coronavirus 3CL Protease Inhibitor CDI-988

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

MAY 31, 2023

BOTHELL, Wash., May 31, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces approval from the Australian Human Research Ethics Committee (HREC) to conduct a Phase 1 study with its novel, oral, broad-spectrum 3CL protease inhibitor CDI-988 as a potential treatment for COVID-19.

The Phase 1 randomized, double-blind, placebo-controlled, dose-escalating study will assess the safety, tolerability and pharmacokinetics of CDI-988 in healthy volunteers. CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and other coronaviruses, and demonstrated a favorable safety profile and pharmacokinetic properties supportive of daily oral dosing. Cocrystal applied its proprietary drug discovery platform technology to design this investigational drug candidate.

“We are excited to have accomplished this milestone and look forward to initiating our CDI-988 clinical program as an oral treatment for patients with COVID-19, as well as demonstrating our drug discovery platform technology capabilities,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “CDI-988 was designed to bind to a highly conserved region of coronavirus and other viral proteases. Recent findings from our preclinical studies also show pan-viral activity against different RNA viruses, enabling the potential for additional clinical benefits. Further exploration of this pan-viral activity is ongoing.”

“Australia is the ideal location to conduct a cost-efficient, high-quality study,” said James Martin, CFO and co-CEO. “The Australian regulatory agency has streamlined the pathway for early-stage clinical studies and their government offers enticing financial incentives. We already have in place an Australian subsidiary and a relationship with a local contract research organization that we established with our influenza A Phase 1 study.”

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.

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 the initiation and characteristics of a Phase 1 study for CDI-988 and the potential efficacy and clinical benefits of such product candidate. 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 risks arising from inflation, interest rate increases, the recent banking crisis, the possibility of a recession and the Ukraine war on our Company, our collaboration partners, and on the U.S., Australia and global economies, including manufacturing and research delays arising labor shortages and other factors, the ability of our Clinical Research Organization partner to recruit volunteers for, and to proceed with, the Phase 1 clinical study for CDI-988, general risks arising from conducting a clinical trial, receipt of regulatory approvals for future trials, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the governmental authorities, and potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we may develop. 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, 2022. 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

# # #

Source: Cocrystal Pharma, Inc.

Released May 31, 2023

Release – Tonix Pharmaceuticals Announces Presentations Involving TNX-1500 (anti-CD40L mAb) at the 2023 American Transplant Congress

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 31, 2023 7:00am EDT

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

CHATHAM, N.J., May 31, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an upcoming oral presentation by Ryo Otsuka, Ph.D., and poster presentation by Kohei Kinoshita, M.D at the 2023 American Transplant Congress (ATC). Both presenters are faculty members at the Center for Transplantation Sciences, Massachusetts General Hospital, and collaborators of Tonix. The Congress is being held June 3-7, 2023, in San Diego, Calif. The research involves studies of Tonix’s TNX-1500 (Fc-modified anti-CD40L monoclonal antibody) for the prevention of renal and cardiac allograft rejection.   A copy of the presentation and poster will be made available on the Scientific Presentations page of the Tonix website at www.tonixpharma.com following the congress.

Oral Presentation Details
Title:  Fc-Modified Anti-Cd154 Mab Induced Long Term Renal Allograft Survival without Thromboembolic Complications
Authors: R. Otsuka, G. Lassiter, T. Hirose, A. Karadagi, T. Tomosugi, I. Rosales, T. Kawai
Date: Tuesday, June 6, 2023
Time: 6:00 p.m. PT
Location: Ballroom 6E Upper Level, San Diego Convention Center, San Diego, Calif.
Number: Presentation 544
   
Poster Presentation Details
Title: aCD154mAb (TNX-1500) Alone, or in Combination with Rapamycin, MMF, or aCD28mAb (VEL-101) Prolongs Cynomolgus Cardiac Allograft Survival
Authors: K. Kinoshita, A. Maenaka, Z. Habibabady, G. McGrath, R. Chaban, I. Ileka, M. Ma, V. Diaz, I. Rosales, S. Fogarty, P. Maguire, B. Daugherty, S. Lederman, R. Pierson III
Date: Saturday, June 3, 2023
Time: 5:30 – 7:30 p.m. PT
Location: Exhibit Halls A & B1, San Diego Convention Center, San Diego, Calif.
Number: Poster Board A030

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 second half of 2023. 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
investor.relations@tonixpharma.com
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
madeline.stabinski@russopartnersllc.com
(212) 845-4273

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

Tonix Pharmaceuticals (TNXP) – New Data To Be Presented For TNX-601 In Major Depressive Disorder

Posted on by cpereira@noblefcm.com


Tuesday, May 30, 2023

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

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.

New Data Puts TNX-601 ER In The Spotlight. Tonix will be presenting data from the Phase 2 UPLIFT study at the American Society of Clinical Psychopharmacology (ASCP) meeting from May 30 to June 2, 2023. The presentation will provide an update on the UPLIFT trial testing TNX-601 EP, including data on the mechanism of action and the development of TNX-4300, the purified (S)-isomer of tianeptine.

Phase 2 UPLIFT Trial In Major Depression Disorder. TNX-601 is an extended-release formulation of tianeptine hemioxalate, a drug used for depression in Europe for over 30 years. The Phase 2 UPLIFT trial is a placebo-controlled trial with 6 weeks of once-daily dosing. The primary endpoint is mean change from baseline in the MADRS (Montgomery-Asberg depression rating scale) at week 6. Top-line results expected in 4Q23.


Get the Full Report

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. 

PDS Biotechnology Corp. (PDSB) – ASCO Abstracts Show Continued Efficacy and Durability

Posted on by cpereira@noblefcm.com


Tuesday, May 30, 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 Abstracts Contain Positive Data Update. On Friday, May 26, abstracts for the Annual Meeting of the American Society of Clinical Oncology (ASCO) were released. As we expected, the data update from the Phase 2 VERSATILE-002 trial showed consistent or improved response rates, overall survival, and progression free survival, with continued safety and tolerability. We believe these data support our expectations of efficacy in the Phase 3 trial, expected to begin in late 2023.

Data Updates Confirm and Support Preliminary Findings. The abstract contains updated interim results from the Phase 2 VERSATILE-002 trial testing the combination of PDS0101 with Keytruda (an anti-PD-1 immune checkpoint inhibitor from Merck). The data presentation will include 34 patients that have reached the 12-month evaluation point, compared with the data from 17 patients evaluated after 9 months presented at ASCO 2022. These new data show strong improvements over ICI monotherapy, the current standard of care, as well as efficacy and strong duration of benefits. 


Get the Full Report

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. 

How Can Scientists Design Opioid Drugs that Won’t Cause Side Effects?

Posted on by phoffman@channelchek.com
Opioid neurotransmitters are located in many areas of the body, including the brain, spine and gut.

Understanding the Molecular Pathways of How Opioids Work

Your body naturally produces opioids without causing addiction or overdose – studying how this process works could help reduce the side effects of opioid drugs. Opioids such as morphine and fentanyl are like the two-faced Roman god Janus: The kindly face delivers pain relief to millions of sufferers, while the grim face drives an opioid abuse and overdose crisis that claimed nearly 70,000 lives in the U.S. in 2020 alone.

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, John Michael Streicher, Associate Professor of Pharmacology, University of Arizona.

Scientists like me who study pain and opioids have been seeking a way to separate these two seemingly inseparable faces of opioids. Researchers are trying to design drugs that deliver effective pain relief without the risk of side effects, including addiction and overdose.

One possible path to achieving that goal lies in understanding the molecular pathways opioids use to carry out their effects in your body.

How Do Opioids Work

The opioid system in your body is a set of neurotransmitters your brain naturally produces that enable communication between neurons and activate protein receptors. These neurotransmitters include small protein-like molecules like enkephalins and endorphins. These molecules regulate a tremendous number of functions in your body, including pain, pleasure, memory, the movements of your digestive system and more.

Opioid neurotransmitters activate receptors that are located in a lot of places in your body, including pain centers in your spinal cord and brain, reward and pleasure centers in your brain, and throughout the neurons in your gut. Normally, opioid neurotransmitters are released in only small quantities in these exact locations, so your body can use this system in a balanced way to regulate itself.

The problem comes when you take an opioid drug like morphine or fentanyl, especially at high doses for a long time. These drugs travel through the bloodstream and can activate every opioid receptor in your body. You’ll get pain relief through the pain centers in your spinal cord and brain. But you’ll also get a euphoric high when those drugs hit your brain’s reward and pleasure centers, and that could lead to addiction with repeated use. When the drug hits your gut, you may develop constipation, along with other common opioid side effects.

Targeting Opioid Signal Transduction

How can scientists design opioid drugs that won’t cause side effects?

One approach my research team and I take is to understand how cells respond when they receive the message from an opioid neurotransmitter. Neuroscientists call this process opioid receptor signal transduction. Just as neurotransmitters are a communication network within your brain, each neuron also has a communication network that connects receptors to proteins within the neuron. When these connections are made, they trigger specific effects like pain relief. So, after a natural opioid neurotransmitter or a synthetic opioid drug activates an opioid receptor, it activates proteins within the cell that carry out the effects of the neurotransmitter or the drug.

Opioid signal transduction is complex, and scientists are just starting to figure out how it works. However, one thing is clear: Not every protein involved in this process does the same thing. Some are more important for pain relief, while some are more important for side effects like respiratory depression, or the decrease in breathing rate that makes overdoses fatal.

So what if we target the “good” signals like pain relief, and avoid the “bad” signals that lead to addiction and death? Researchers are tackling this idea in different ways. In fact, in 2020 the U.S. Food and Drug Administration approved the first opioid drug based on this idea, oliceridine, as a painkiller with fewer respiratory side effects.

However, relying on just one drug has downsides. That drug might not work well for all people or for all types of pain. It could also have other side effects that show up only later on. Plenty of options are needed to treat all patients in need.

My research team is targeting a protein called Heat shock protein 90, or Hsp90, which has many functions inside each cell. Hsp90 has been a hot target in the cancer field for years, with researchers developing Hsp90 inhibitors as a treatment for many cancer types.

We’ve found that Hsp90 is also really important in regulating opioid signal transduction. Blocking Hsp90 in the brain blocked opioid pain relief. However, blocking Hsp90 in the spinal cord increased opioid pain relief. Our recently published work uncovered more details on exactly how inhibiting Hsp90 leads to increased pain relief in the spinal cord.

Our work shows that manipulating opioid signaling through Hsp90 offers a path forward to improve opioid drugs. Taking an Hsp90 inhibitor that targets the spinal cord along with an opioid drug could improve the pain relief the opioid provides while decreasing its side effects. With improved pain relief, you can take less opioid and reduce your risk of addiction. We are currently developing a new generation of Hsp90 inhibitors that could help realize this goal.

There may be many paths to developing an improved opioid drug without the burdensome side effects of current drugs like morphine and fentanyl. Separating the kindly and grim faces of the opioid Janus could help provide pain relief we need without addiction and overdose.

Release – PDS Biotech Announces Interim Data Demonstrates 12-Month Survival Rate of 87% with PDS0101 in Combination with KEYTRUDA® (pembrolizumab) for Head and Neck Cancer Patients

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

  • Interim data being presented at ASCO 2023 Annual Meeting
  • Demonstrated median progression-free survival (PFS) of 10.4 months
  • Demonstrated 12-month overall survival (OS) rate of 87.1%
  • A disease control rate (disease stabilization or tumor shrinkage) of 70.6%
  • Median overall survival not yet met

Company to host conference call and webcast on June 6, 2023, at 8:00 am ET

FLORHAM PARK, N.J., May 25, 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, announced 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), in patients with unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer. The results will be featured in a poster presentation and in a head and neck cancer expert panel discussion at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held June 2-6 in Chicago.

The presentation, titled “Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and Pembrolizumab in HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC)” (Abstract #6012), concluded that the combination was well tolerated, and the results justify a global confirmatory randomized, controlled study, VERSATILE-003, which PDS Biotech is planning to initiate this year. The study’s 48 ICI naïve participants, 94% of whom were male with a median age of 62.5, received at least one cycle of the combination arm, 56.3% received four doses, and 22.9% received five doses.

In measuring the efficacy of PDS0101 in combination with KEYTRUDA®, the abstract highlights the following interim data:

  • Estimated 12-month overall survival rate was 87.1%. Published results are 36-50% with approved ICIs used alone*.
  • Median progression-free survival was 10.4 months (95% CI 4.2, 15.3). Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels*.
  • A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34)
  • Confirmed and unconfirmed objective response rate was 41.2% (14/34 patients), which is identical to the preliminary response rate data PDS Biotech previously reported at ASCO 2022 (7/17 patients). To date these responses have been confirmed in nine of the 34 patients (26.5%), including one complete response.
  • 15/34 patients (44.1%) had stable disease.
  • 9/34 patients (26.5%) had progressive disease.
  • 4/48 (8.3%) of patients had a Grade 3 treatment-related adverse event (TRAE). No Grade 4 or higher TRAEs were observed.

VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with KEYTRUDA® in adults with HPV16-positive unresectable, recurrent or metastatic HNSCC. VERSATILE-002 is investigating two patient populations of HPV16-positive head and neck cancer patients whose cancer has returned or spread. Interim data from the first group, which had not been previously treated with an ICI (ICI naïve), is the focus of the ASCO poster presentation and follow-up discussion among a panel of head and neck cancer experts. The second group of patients had previously failed treatments including ICI therapy (ICI refractory).

“We are pleased to present updated survival data from VERSATILE-002, which suggest the addition of PDS0101 to KEYTRUDA® may improve survival for the growing number of HPV16-positive head and neck cancer patients,” said Katharine A. Price, MD, Associate Professor, Oncology Head and Neck Disease Group, Mayo Clinic and presenting author of the study.

“The interim data showed an estimated 12-month survival rate of 87% and a progression-free survival of 10.4 months, which is very encouraging given the poor prognosis these patients face,” stated Lauren V. Wood, M.D., PDS Biotech’s Chief Medical Officer and a co-author of the study. “Furthermore, we remain encouraged by the safety profile of PDS0101 in combination with KEYTRUDA®, with only 8% of patients experiencing a Grade 3 treatment-related adverse event without more serious Grade 4 or 5 events. We believe these data are encouraging for HNSCC patients and indicate that the addition of the HPV16-targeted immunotherapy PDS0101 to KEYTRUDA® should be further evaluated for its potential to enhance survival in HPV16-positive head and neck cancer patients.”

The research was authored by Katharine Price, M.D., Mayo Clinic; John Michael Kaczmar, M.D., Medical University of South Carolina; Francis Worden, M.D., University of Michigan Health; Marya Chaney, Ph.D., Merck & Co. Inc.; Jared Weiss, M.D., University of North Carolina, Chapel Hill; and PDS Biotech’s Lauren V. Wood, M.D; David Schaaf, M.D.; and Nathalie Riebel.

Details of the presentation are as follows:

Abstract Number: 6012

Abstract Title: Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and Pembrolizumab in HPV16-Positive Head and Neck Squamous Cell Carcinoma (HNSCC)

Presenting Author: Katharine Price, M.D., Co-chair, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center

Session Title: Head and Neck Cancer

Poster Presentation: Monday, June 5, 2023, 1:15 PM-4:15 PM CDT

Head and Neck Cancer Poster Discussion Session: Monday, June 5, 2023, 4:30 PM-6:00 PM CDT

Conference Call Information:

PDS Biotech will host a conference call on Tuesday, June 6, at 8:00 a.m. EDT 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).

*No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101; Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B et al., Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE- 048): a randomized, open-label phase 3 study; Lancet 2019; 394(10212):1915-1928
https://www.opdivo.com/head-and-neck-cancer
https://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/

About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression, and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-002
VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.   

Interim efficacy and safety data will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting for ICI-naïve patients. Preliminary data from the first 34 patients demonstrated a 12-month overall survival rate of 87% and median progression free survival of 10.4 months. No Grade 4 or higher treatment related adverse events were observed.

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

About Versamune®
Versamune® is a novel investigational T-cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune® based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard-of-care treatments. Clinical data suggest that Versamune® based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression, and/or prolonging survival. Versamune® based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune® based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety, and tolerability.

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. 

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 the Company’s 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. 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 other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. 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 Contacts: 
Tiberend Strategic Advisors, Inc.
Dave Schemelia 
Phone: +1 (609) 468-9325 
dschemelia@tiberend.com

Bill Borden 
Phone: +1 (732) 910-1620 
bborden@tiberend.com