Category: Health

GeoVax Labs, Inc. (GOVX) – 3Q23 Quarterly Report Includes 2024 Milestones

Posted on by [email protected]


Thursday, November 09, 2023

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 three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). 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.

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.

GeoVax Announces 2024 Milestones and 3Q23 Financial Results. GeoVax reported a 3Q23 loss of $8.4 million or $(0.32) per share. The company reviewed the progress made during the quarter, including completion of enrollment for the Phase 2 trial testing CM04S1 as a booster in healthy patients, presentation of data from the Phase 1/2 data for Gedeptin showing safety and tumor reduction, and addition of 3 new clinical sites for the Phase 2 trial for CM04S1 in immunocompromised patients.

CM04S1 Has Made Progress In Three Trials. Enrollment has been completed in the Phase 2 trial testing CM04S1 as a booster for healthy patients that had received the Pfizer or Moderna mRNA vaccines. An announcement of the top-line data is expected shortly. As discussed in our Research Note on September 25, a publication of data from the Phase 2 trial in immuno-compromised patients showed both humoral and cellular immune responses in patients that have difficulty responding to vaccination. Three new clinical sites were also added to the trial. An Investigator Initiated Trial (IIT) in chronic lymphocytic leukemia (CLL) is expected to announce interim data in the coming months. 


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*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. 

Apollo Medical Scales Medicaid Presence with Purchase of CFC

Posted on by [email protected]

Healthcare investor favorite Apollo Medical Holdings (NASDAQ: AMEH) is expanding its presence in value-based care arrangements through the acquisition of Community Family Care (CFC), a large independent physician association based in Los Angeles. The all-cash deal worth up to $202 million reflects ApolloMed’s strategy of targeting risk-bearing providers as a high-growth segment of the health biotech sector.

CFC manages care for over 200,000 members via its network of more than 350 primary care physicians and 500 specialists. The group has a strong presence in Medicaid, with a Restricted Knox Keene (RKK) license enabling it to take on full risk for this population in California. CFC also serves Medicare and commercial members under value-based contracts that incentivize providers to control costs and improve health outcomes.

For ApolloMed, acquiring CFC significantly boosts its portfolio of managed lives, particularly under global capitation arrangements that cover total cost of care. Additionally, CFC’s long track record of profitability in Medicaid provides ApolloMed with demonstrated capabilities to take on risk successfully in a population that is often challenging for providers.

The deal exemplifies a unique competitive edge for ApolloMed – its end-to-end platform spanning technology, management services, and risk contracting. CFC has utilized ApolloMed’s care enablement tools since 2020, allowing it to perform well under value-based care. Now, full acquisition enables tight integration and aligned incentives as CFC transitions to an ApolloMed care partner responsible for total cost and outcomes.

For 2023, CFC is expected to generate $190 million in revenue with $25 million in adjusted EBITDA, an impressive 13% margin for a risk-bearing provider group. ApolloMed has agreed to an acquisition price of up to $202 million, including $152 million in cash, $20 million in ApolloMed stock, and $30 million in potential milestone payments. The deal is anticipated to close in Q1 2024 after clearing regulatory reviews.

Rapid Growth in Value-Based Care

The acquisition comes at a time of rapid expansion in value-based care, where providers take on financial accountability for cost and quality of healthcare for a population of patients. Government and commercial payers are pushing providers into these arrangements to incentivize focus on preventative care and eliminating wasteful spending.

Analysts size the global market for value-based care at $3.1 billion by 2030, reflecting a blistering compound annual growth rate of 21.7% from 2022. In the United States, value-based care penetration is expected to reach 65% of healthcare payments by 2025.

ApolloMed is positioned at the forefront of this transformation with its integrated platform and focus on enabling providers, such as CFC, to take on risk successfully. The CFC deal adds a sizable value-based care presence to ApolloMed’s portfolio, demonstrating the appetite to aggressively scale its model with like-minded partners.

Targeting High-Growth Segments

The CFC acquisition also highlights ApolloMed’s focus on areas of healthcare with strong secular tailwinds: government programs and risk-based arrangements.

Medicaid represents a massive $650 billion total addressable market, and ApolloMed is specifically targeting expansion in California, which has among the most progressive Medicaid programs in supporting coordinated care models. CFC’s strong capabilities in the Medicaid population will be a key strategic asset.

Likewise, ApolloMed’s thesis of investing behind risk-bearing providers is underscored by CFC’s demonstrated ability to generate double-digit margins while managing patients under capitated contracts. As fee-for-service reimbursement models decline, providers capable of taking on risk will be increasingly valuable.

Wall Street’s View

ApolloMed has been a darling of growth investors, with shares up 270% over the past five years. Revenue and EBITDA have compounded annually at 50% and 90%, respectively, as the company scales its platform.

The market continues to reward this rapid expansion, with ApolloMed trading at a premium valuation of 50x P/E. Bulls believe the company’s strategy and competitive moats position it for continued acceleration as value-based care proliferates.

Meanwhile, bears argue that ApolloMed’s nosebleed valuation leaves little room for error. There are also concerns around rising fragmentation in California’s Medicaid market challenging operators.

However, with impressive unit economics and strong execution thus far, ApolloMed has many convinced it can maintain momentum. The CFC deal offers further validation of the company’s model and market opportunity. Investors will be watching closely for successful integration and financial accretion.

If ApolloMed can effectively leverage CFC to penetrate Medicaid and value-based arrangements more deeply, the deal may be looked back upon as an inflection point in the company’s growth story. At minimum, it provides another data point for ApolloMed’s ability to execute on acquisitions rapidly expanding its national footprint – a core piece of the bull thesis.

MustGrow Biologics Corp. (MGROF) – Receiving More Approval

Posted on by [email protected]


Wednesday, November 08, 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 Approval. Yesterday, MustGrow announced the Company received Health Canada’s Pest Management Regulatory Agency (PMRA) approval to commence large-scale field trials via NexusBioAg’s 2024 BioAdvantage Trials Program (BAT Program). The program will focus on the Company’s TerraMG mustard-derived soil biopesticide technology for use in Canadian canola and pulse crop markets.

NexusBioAg BAT Program. The BAT Program is an industry leading field trialing program with an established process to gather data from large field scale trials across Canada. NexusBioAg, a partner of MustGrow and the operator of the program, validates product efficacy and establishes the product value and opportunity. Through the BAT Program, NexusBioAg farm customers will have access to MustGrow’s mustard plant-based product.


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

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

Release – PDS Biotechnology Announces Conference Call and Webcast for Third Quarter 2023 Financial Results

Posted on by [email protected]

Research News and Market Data on PDSB

PRINCETON, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that the Company will release financial results for the third quarter of 2023 on Tuesday, November 14, 2023, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.

Tuesday, November 14, 2023, 8:00 AM ET
Domestic: 877-407-3088
International: 201-389-0927
Conference ID: 13741454

Webcast: PDS Biotech Earnings Webcast

After the live webcast, the event will be archived on PDS Biotech’s website for six months.

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® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts:
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 Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: [email protected]

Release – MAIA Biotechnology Reports Third Quarter 2023 Financial Results And Highlights Recent Development Progress For Anticancer Asset THIO

Posted on by [email protected]

Research News and Market Data on MAIA

November 07, 2023 8:15am ESTDownload as PDF

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  • Substantial THIO program progress including unprecedented disease control rate (DCR) of 100% in second-line non-small cell lung cancer (NSCLC)
  • Key THIO findings in gliomas, pediatric brain cancer, and second generation THIO-derived cancer therapies
  • Strong pace of enrollment in THIO-101 Phase 2 trial exceeds average enrollment pace in similar NSCLC trials

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, today reported financial results for the third quarter ended September 30, 2023 and key operational updates.

“Our successful and productive third quarter was punctuated by the outstanding data on our lead asset THIO that we recently revealed, and an accelerating pace of enrollment in our THIO-101 Phase 2 trial,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “We are expanding our trial in Europe, and with the FDA’s recent clearance for THIO studies in the U.S. as part of THIO-101, we have reached an essential milestone in the clinical development of THIO. Preliminary efficacy data from the trial is excellent and includes an unprecedented disease control rate (DCR) of 100% in second-line NSCLC treatment, far surpassing the standard of care DCR of 53-64%. We achieved the pre-determined statistical requirements to proceed to the next stage of the trial earlier than expected, and we look forward to sharing our continuing progress in the coming months and into 2024.”

Third Quarter Business Highlights and Recent Developments

THIO Program

Announced 100% Disease Control in Second-Line Non-Small Cell Lung Cancer Demonstrating Impressive Positive Preliminary Efficacy Data: 100% preliminary DCR was observed in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment. DCRs across all dose levels met the pre-determined statistical requirements earlier than expected to proceed to next stage of the THIO-101 Phase 2 trial.

Highly Potent Anticancer Activity in Gliomas: MAIA’s lead asset THIO showed highly potent anticancer activity in models of glioma, an aggressive type of brain tumor that originates from glial cells and is among the most difficult-to-treat cancers. As a monotherapy, THIO demonstrated efficacy in multiple glioma cell lines that had acquired resistance to the current state-of-the-art care temozolomide (TMZ).

THIO as Potential Therapy for Pediatric Brain Cancer: Study data showed THIO’s potent anticancer activity in diffuse intrinsic pontine glioma (DIPG), one of the most aggressive tumors affecting the central nervous system in children. The treatment resulted in noticeably increased tumor sensitivity to immune or ionizing radiation therapies.

Higher Anticancer Potency of Next Generation THIO Conjugates: Positive Investigational New Drug-enabling study data on telomere-targeting agents derived from lipid-modified THIO molecules warrant further in vivo in-depth investigation of THIO-like agents as second generation cancer therapies.

THIO-101 Phase 2 Clinical Trial

U.S. FDA Clearance of THIO IND Application: The U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application enabling THIO to be evaluated in the U.S. as part of THIO-101, the Company’s ongoing global phase 2 clinical study in patients with advanced non-small cell lung cancer (NSCLC). THIO is being tested in sequential combination with a checkpoint inhibitor (CPI) to evaluate anti-tumor activity and immune response in NSCLC patients.

Strong Pace of Enrollment in THIO-101: 49 patients have been dosed to date at a pace of enrollment that is currently exceeding the average enrollment pace in similar NSCLC trials. Out of the 49 patients dosed, 37 have already completed at least one post baseline assessment.

Continuing Positive Preliminary Survival Data: The first 2 subjects dosed on trial (both receiving 3rd line of treatment) reported long term survival of 14.6 and 12.5 months, respectively, at the latest post baseline assessment with no new anti-cancer treatment initiated. Follow up was ongoing for the first subject at the time of data cut-off.

Third Quarter 2023 Financial Results

Cash Position: Cash totaled approximately $6.1 million as of September 30, 2023, compared to $10.9 million in cash as of December 31, 2022.

Research and Development (R&D) Expenses: R&D expenses were approximately $2.6 million for the quarter ended September 30, 2023, compared to approximately $2.3 million for quarter ended September 30, 2022. The increase was primarily related to an increase in scientific research expenses.

General and Administrative (G&A) Expenses: G&A expenses were approximately $2.4 million for the quarter ended September 30, 2023, compared to approximately $1.7 million for the quarter ended September 30, 2022. The increase for the quarter was primarily related to an increase in professional fees related to the write-off of deferred offering costs and an increase in investor relations costs.

Other Income, Net: Other income was approximately $0.08 million for the quarter ended September 30, 2023, compared to other income, net of $0.19 million for the quarter ended September 30, 2022, primarily related to a change in the fair value of warrant liability.

Net Loss: Net loss was approximately $4.9 million, or $0.36 per share, for the quarter ended September 30, 2023, as compared to net loss of approximately $4.9 million, or $0.48 per share, for the quarter ended September 30, 2022. Weighted average shares outstanding were 13,675,802 in the third quarter of 2023, compared to 10,165,622 in the third quarter of 2022.

For additional information on the Company’s financial results for the quarter ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to an anti-PD-1 agent will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors including: (i) lower than anticipated rate of patient enrollment, (ii) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (iii) our ability to advance product candidates into, and successfully complete, clinical studies, (iv) the timing or likelihood of regulatory filings and approvals, (v) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (vi) the rate and degree of market acceptance of our product candidates, (vii) the size and growth potential of the markets for our product candidates and our ability to serve those markets, (viii) our ability to obtain and maintain intellectual property protection for our product candidates and (ix) other risks and uncertainties detailed from time to time in our filings with the Securities and Exchange Commission, including without limitation our periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231107515213/en/

Investor Inquiries
MAIA Biotechnology
Joseph McGuire
Chief Financial Officer
[email protected]
904-228-2603

Investor Relations
[email protected]

Source: MAIA Biotechnology, Inc.

Released November 7, 2023

Release – MustGrow Receives PMRA Approval to Commence Large Scale Field Trials via NexusBioAg BAT Program

Posted on by [email protected]

Research News and Market Data on MGROF

MustGrow Receives PMRA Approval to Commence Large Scale Field Trials via NexusBioAg BAT Program

  • Approval from Health Canada’s Pest Management Regulatory Agency (PMRA) to commence large-scale farmer trials.
  • Program to focus on MustGrow’s TerraMG™ mustard-derived soil biopesticide technology for use in Canadian canola and pulse crop markets.
  • NexusBioAg’s 2024 BioAdvantage Trials (BAT) Program to evaluate large-scale efficacy and commercial value potential.
  • MustGrow and NexusBioAg are committed to launching innovative, sustainable, and regenerative agriculture products.

SASKATOON, Saskatchewan, Canada, November 7, 2023 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) is pleased to announce the approval of Health Canada’s Pest Management Regulatory Agency (“PMRA”) to commence large-scale field trials via NexusBioAg’s 2024 BioAdvantage Trials Program (“BAT Program”). NexusBioAg, is a division of Univar Solutions, providing an expanded portfolio of crop nutrition solutions, including industry-leading inoculants, micronutrients, nitrogen stabilizers, and foliar products. NexusBioAg is partnered with MustGrow to provide TerraMGTM to Canadian farmers, upon PMRA registraion, as a preplant soil treatment for diseases affecting canola and pulse crops.

NexusBioAg’s BAT Program is recognized as an industry leading field trialing program with an established process to gather data from large field scale trials across Canada. Since it’s inception, NexusBioAg continues to expand the BAT Program footprint and engage with collaborators to evaluate products in the NexusBioAg pipeline. Through the BAT Program, NexusBioAg validates product efficacy and establishes the product value and opportunity. To learn more about the BAT Program visit www.nexusbioag.com/bioadvantage-trials.

The BAT Program will focus on MustGrow’s TerraMGTM mustard-derived soil biopesticide technology for use in Canadian canola and pulse crop markets. The addition of this plant-based technology to the BAT Program further diversifies and expands NexusBioAg’s extensive portfolio of inoculants, micronutrients, nitrogen stabilizers and foliars for the Canadian agricultural market.

“There has been a significant amount of grower interest in MustGrow’s TerraMGTM and there is excitement to evaluate TerraMGTM in real farming conditions during the 2024 BAT Program. We will collaborate with MustGrow to conduct large scale field trials throughout Western Canada and give agriculture innovators an opportunity to work with true agriculture innovation,” remarked Daniel Samphir, NexusBioAg Senior Marketing Manager.

In 2021, NexusBioAg and MustGrow initiated a field research program to develop MustGrow’s sustainable farming technology in Canadian canola and pulse crops. This technology has the potential to address the agronomic challenges of clubroot and aphanomyces diseases which are rapidly devastating these crops. Building on existing collaborative data, NexusBioAg and MustGrow are now moving forward to the next stage of the registration process. Through the BAT Program, NexusBioAg farm customers will have access to MustGrow’s mustard plant-based agronomic innovation.

NexusBioAg is committed to launching innovative, cutting-edge products, with a focus on sustainability and regenerative agriculture, which benefit the Canadian agricultural industry and growers. MustGrow specializes in the research and development of organic biocontrol, soil amendment and biofertility technologies from mustard, harnessing the plant’s natural defense mechanism with technologies that have the potential to control diseases, pests and weeds, and in addition, provide nutrients to boost the soil microbiome. Combining the proficiencies of both companies in the agriculture market will help Canadian farmers benefit from innovative and sustainable farming solutions.

Clubroot Disease: Canola

Clubroot is a rapidly spreading disease pathogen destroying canola, one of Canada’s more profitable crops with over 20 million acres grown each year and contributing C$30 billion in economic activity in Canada.(1) Industry experts conservatively estimate C$500 million in annual canola crop losses in Canada caused by Clubroot.(2) Current treatments cannot eradicate clubroot completely – they are only intended to slow the spread and reduce the incidence and severity of the disease. Some field infections may lead to 100% crop loss.

Aphanomyces Disease: Pulse Crops

Aphanomyces is a water mould pathogen responsible for root-rot disease, infecting a variety of peas, lentils and other legumes collectively referred to as pulse crops. The disease causes severe root damage and wilting, with yield losses ranging from 10% to 100% in infected fields.(2) Canada is one of the world’s largest producers of pulse crops, with approximately 7 to 10 million arces grown annually with an estimated farm gate value of over C$3.5 billion, and the world’s largest exporter.(3) Industry experts conservatively estimate C$125 million in annual pulse crop losses due to aphanomyces.(2) Current treatment measures cannot control aphanomyces – they are only able to slow down the spread and reduce the incidence and severity of the disease.

The global plant-based protein market size is projected to grow from US$14.1 billion in 2021 to US$17.4 billion by 2027 (CAGR of 3.7%).(4) This is attributed to several drivers, predominantly rising consumer health-consciousness, growing prevalence of protein-rich pulse crop food products, and technological innovations in plant-based protein extraction.

Sources:
1. Canola Council of Canada https://www.canolacouncil.org/sustainability/economic/
2. 3rd party market research, MustGrow estimates
3. imarcgroup.com; https://pulsecanada.com/uploads/National-Pulse-Research-Strategy-Jan-10.pdf
4. https://www.ey.com/en_gl/strategy/how-alternative-proteins-are-reshaping-meat-industries

For more information about NexusBioAg’s crop nutrition solutions, please visit www.nexusbioag.com.  To learn more about TerraMG™, visit www.mustgrow.ca.

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 technologies 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 50.1 million basic common shares issued and outstanding and 55.0 million shares fully diluted. For further details, please visit www.mustgrow.ca.

Contact Information

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: the potential outcomes of the BAT Program trials of MustGrow’s TerraMGTM; the focus of the BAT Program on MustGrow’s TerraMGTM mustard-derived soil biopesticide technology for use in Canadian canola and pulse crop markets; the potential of MustGrow’s TerraMGTM technology to address the agronomic challenges of clubroot and aphanomyces diseases on canola and pulse crops; and the potential outcome of any registration process for MustGrow’s TerraMGTM.

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 market receptivity to investor relations activities as well as those 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 – ZyVersa Therapeutics Announces Article in Peer-Reviewed Journal, Ecotoxicology and Environmental Safety, Linking Air Pollution with Development and Progression of Chronic Kidney Disease That Can Be Attenuated by Inhibiting Inflammasome NLRP3 Activation

Posted on by [email protected]

Research News and Market Data on ZVSA

Nov 6, 2023

PDF Version

  • Despite decades of effective environmental policy and improved air quality in the US, air pollution remains the greatest environmental health risk factor, contributing to 100,000 to 200,000 incremental deaths annually, primarily from fine particulate matter (PM2.5) derived from pollutants including vehicle and industrial emissions from fuel and biomass combustion, cigarette smoke, volcanos, fires, and desert dust.
  • PM2.5 is inhaled into the lungs, spreading through the bloodstream to other organs, especially the kidney, which accumulates it during glomerular filtration, where it triggers NLRP3 inflammasome activation resulting in damaging inflammation and cell death (pyroptosis) leading to chronic kidney disease and its progression.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100 which can inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks which perpetuate damaging inflammation.

WESTON, Fla., Nov. 06, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Ecotoxicology and Environmental Safety, demonstrating that inhibiting NLRP3 inflammasomes can attenuate kidney damage and dysfunction associated with the environmental pollutant, PM2.5.

In the paper titled, “PM2.5 induces renal tubular injury by activating NLRP3-mediated pyroptosis,” the authors conducted studies in a mouse model exposed to high concentrations of ambient PM2.5 for 12 weeks, and in a mouse kidney cell line. Following are key findings reported in the paper:

  • PM2.5 exposure leads to kidney structural changes and functional impairment.
  • Inflammasome NLRP3-induced Inflammation and pyroptosis were increased in PM2.5-exposed kidney tissues.
  • Inhibiting the inflammasome NLRP3 pathway, including downstream caspase-1, rescued the kidneys from PM2.5-induced cell death.

The authors stated, “We further provided evidence that NLRP3-mediated pyroptosis plays critical roles in the progression of kidney injury induced by PM2.5 exposure. Inhibiting the activation of NLRP3 inflammasome can remarkably protect the renal tubular epithelial cells from PM2.5-induced proptosis.” To read the article, Click Here.

“The research published in the Journal, Ecotoxicology and Environmental Safety, reinforces other published data demonstrating that inhibiting NLRP3 inflammasomes can attenuate kidney damage and dysfunction of multiple causes, now including kidney damage associated with the environmental pollutant, PM2.5,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “This research provides increasing support for inflammasome inhibition as a promising treatment option for kidney disease, a major health problem affecting over 35 million adults in the United States. ZyVersa is developing Inflammasome ASC inhibitor IC 100. Unlike NLRP3 inhibitors, designed to inhibit formation of one inflammasome to block initiation of the inflammatory cascade, IC 100 was designed to inhibit multiple types of inflammasomes and their associated ASC specks to uniquely block both initiation and perpetuation of damaging inflammation.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate 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, 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 in 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 for treatment of 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

Cargo Therapeutics Positions for One of 2023’s Largest Biotech IPOs

Posted on by [email protected]

Cargo Therapeutics is gearing up for an initial public offering (IPO) that could be one of the biggest biotech listings in 2023. The cancer-focused gene therapy startup aims to raise around $300 million through the sale of 18.75 million shares priced between $15 to $17.

If successful, it would be a rare bright spot in an otherwise dreary IPO market for life science companies this year. Cargo’s offering comes at a time when biotech IPOs have slowed to a trickle amid volatile market conditions.

The company is developing CRG-022, an experimental CD22 CAR-T therapy for certain blood cancers. Cargo’s candidate takes a patient’s own T-cells and engineers them to target and kill cancerous B-cells expressing the CD22 antigen.

Cargo hopes CRG-022 can benefit patients with large B-cell lymphoma who have failed previous CD19 CAR-T treatment. It initiated a potentially pivotal Phase 2 trial for this population in September. Data from the study could support regulatory approval in 2025.

Beyond blood cancers, Cargo intends to study CRG-022 in solid tumors expressing CD22. This includes some forms of breast, lung, colorectal and liver cancers. The company believes its therapy may demonstrate activity in a wider range of advanced cancers than existing CAR-Ts.

Proceeds from the IPO will help fund Cargo’s clinical programs and earlier R&D. According to its SEC filing, the company had $42.4 million in cash at the end of June 2022 but accumulated losses exceeding $77 million. The capital infusion will provide runway through the expected interim Phase 2 data readout.

Take a moment to take a look at more emerging biotech companies by looking at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.

Cargo’s offering will be a key test of investor appetite for preclinical biotech IPOs. These platform companies developing multiple experimental drugs based on a core technology have fallen out of favor recently.

However, Cargo could attract more interest with CRG-022 already in mid-stage testing and potential for near-term commercialization. The FDA has approved several CAR-T cell therapies over the past five years, providing a regulatory pathway for followers like Cargo.

But biotech IPOs in general face challenges in the current environment. Volatility, rising interest rates, and recession fears have rocked stock markets in 2022. Biotech has been among the hardest hit sectors, with the Nasdaq Biotech Index down over 30% year-to-date.

Companies pursuing IPOs have been forced to scale back valuations and offering sizes. Those that do list are often trading below issue price. So far in 2022, only around 15 biotechs have braved public markets compared to 60+ in recent years.

Yet some experts believe companies with innovative therapies and strong data can still obtain IPO financing. Cargo will provide a barometer of latent investor demand for biotech offerings amid the downturn.

A successful IPO could potentially reinvigorate biotech’s depressed financing environment. It may encourage other firms contemplating IPOs to move forward with planned deals.

Conversely, a lackluster response would signal biotech IPOs remain out-of-favor for now. This could lead companies to instead pursue private financing to advance programs and extend runways.

In any case, Cargo’s listing will generate insight into the health of biotech capital markets. The deal’s performance could significantly influence investment decisions and sentiment around the battered sector heading into 2023.

All eyes will be on whether one of biotech’s most promising young companies can buck the prevailing IPO trends. Cargo’s offering will help determine if the window for issuance might finally be opening back up.

Eledon Pharmaceuticals (ELDN) – Phase 1b Data Shows Safety With An Important Improvement In Kidney Function

Posted on by [email protected]


Friday, November 03, 2023

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.

Update From Phase 1b Trial Presented. Eledon presented updated data from its Phase 1b open-label trial testing tegoprubart for prevention of kidney transplant rejection. The data showed tegoprubart was comparable or better than tacrolimus in safety and tolerability, its primary endpoint. One of the secondary endpoints measuring kidney function showed a substantial improvement over tacrolimus. We see this data as a strong positive for tegoprubart.

Tegoprubart Is In Development To Replace Tacrolimus. The calcineurin inhibitor tacrolimus is the current standard of care for preventing transplant rejection. It has a success rate of over 90% first year graft survival, but its side effects include toxicity to the kidney and pancreas. These toxicities cause new onset diabetes and graft failure. The open-label trial tested a regimen with tegoprubart instead of tacrolimus along with the other standard-of-care drugs. 


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Release – Onconova Therapeutics’ ASH Poster To Focus On Narazaciclib In MCL

Posted on by [email protected]

Research News and Market Data on ONTX

Nov 02, 2023

PDF Version

Preclinical data indicate that narazaciclib shows monotherapy and combination anti-tumor activity in ibrutinib-sensitive and resistant cells and xenograft models

NEWTOWN, Pa., Nov. 02, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Onconova and collaborators will present a preclinical poster related to its lead program, narazaciclib, at the 65th American Society for Hematology Annual Meeting & Exposition (ASH), taking place in San Diego, California from December 9 to 12, 2023.

“The poster that we and researchers from the Josep Carreras Leukaemia Research Institute in Barcelona, Spain are presenting at ASH 2023 shows that the study of narazaciclib, either as a single agent or in combination with ibrutinib, effectively controls tumor growth in preclinical models of mantle cell lymphoma (MCL), including those that are resistant to Bruton’s tyrosine kinase inhibitors (BTKis), a mainstay of care for this aggressive and difficult to treat cancer. The experiments included a broad comparison of narazaciclib with three other approved cyclin-D-kinase inhibitors (CDKis), used in combination with several BTKis,” said Steven Fruchtman, M.D., President and CEO of Onconova.

Dr. Fruchtman continued, “We were especially pleased by the broad translational data set that provided an understanding of narazaciclib’s role in cell cycle blockade. These studies show that narazaciclib appears to act in the G1 phase of the cell cycle. Furthermore, the studies also indicate that the combination of narazaciclib and ibrutinib act in a synergistic way to achieve in vitro and in vivo anti-tumor activity in ibrutinib sensitive- and resistant -cells and xenograft models. Together, these data support the potential use of narazaciclib in MCL and other cyclin-dependent indications, and further inform our understanding of narazaciclib’s mechanism of action as we advance the clinical program, led by the Phase 1/2a study in patients with low grade endometrioid endometrial cancer, an indication with a great unmet medical need.”

Poster Presentation Information:

Title: Narazaciclib, a Differentiated CDK4/6 Antagonist, Prolongs Cell Cycle Arrest and Metabolomic Reprogramming, Enabling Restoration of Ibrutinib Sensitivity in Btki-Resistant Mantle Cell Lymphoma
Session Name: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster III
Session Date: Monday, December 11, 2023
Presentation Time: 6:00 PM – 8:00 PM PT
Location: San Diego Convention Center, Halls G-H
Poster Number: 4181 
Presenters: Dr. Nuria Profitos-Peleja, Lymphoma Translational Group, Josep Carreras Leukaemia Research Institute, Barcelona, Spain

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer.

Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).

For more information, please visit www.onconova.com.

Forward Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
[email protected] 

Release – Eledon Reports Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation

Posted on by [email protected]

Research News and Market Data on ELDN

November 2, 2023

PDF Version

Data from 11 participants demonstrates tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated

Aggregate mean eGFR was above 70 mL/min/1.73m2 at all reported time points after day 90 supporting tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation

Eledon will host a conference call today at 5:00 p.m. ET

IRVINE, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported results from the Company’s ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing de novo kidney transplantation. Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting taking place in Philadelphia, PA from November 2-5, 2023.

“We are excited to present updated safety and efficacy results from our ongoing Phase 1b trial which continue to support the potential of tegoprubart as a novel kidney transplant immunosuppressive therapy to prevent rejection and better preserve organ function without many of the side effects associated with tacrolimus, the current standard of care,” said David-Alexandre C. Gros, M.D., Chief Executive Officer. “We remain committed to the transplant community who are in urgent need of better treatment options, and we look forward to continuing this study in parallel with our Phase 2 BESTOW study initiated earlier this year.”

At the time of data submission, results from the 11 participants in the Phase 1b trial demonstrated that tegoprubart is generally safe and well-tolerated in patients undergoing kidney transplantation. There have been no cases of hyperglycemia, new onset diabetes, tremor, or cytomegalovirus infection commonly seen with tacrolimus. One participant experienced a mild T cell mediated rejection (Banff score 1a) on day 99. This patient was treated for the rejection and remains in the study. There were no cases of graft loss or death.

Aggregate mean estimated glomerular filtration rate (eGFR) – a measure of kidney function – was above 70 mL/min/1.73m2 at all reported time points after day 90. Historical studies have reported average eGFRs generally in the low 50 mL/min/1.73m2 range during the first year after kidney transplant using standard of care. One participant has completed the study with an eGFR of 91 at one year (day 374) and is now enrolled in a Phase 2 open-label extension (OLE) study, which will evaluate the long-term safety, pharmacokinetics, and efficacy of tegoprubart in participants who have completed one year of treatment in either the ongoing Phase 1b or Phase 2 BESTOW study.

“In this Phase 1b trial, patients treated with tegoprubart demonstrated robust improvements in eGFR with a strong safety profile,” said Dr. John S. Gill, MD, Professor of Medicine at the University of British Columbia, St. Paul’s Hospital, Vancouver, Canada, and Principal Investigator of the study. “These results further support the promise of CD40L costimulatory blockade in organ transplantation. I look forward to additional readouts from this study in 2024.”

The Phase 1b open-label study has enrolled 11 participants who underwent kidney transplantation in Canada, Australia, and the United Kingdom. Each participant received rabbit antithymocyte globulin (ATG) induction and a maintenance regimen consisting of tegoprubart, mycophenolate mofetil, and corticosteroids. The primary endpoint of the study is safety. Other endpoints include characterizing the pharmacokinetic profile of tegoprubart, the incidence of biopsy proven rejection, and eGFR.

In September, Eledon announced that the first participant had been dosed in the Company’s Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. The multicenter, two-arm, active comparator clinical study is enrolling approximately 120 participants undergoing kidney transplantation in the United States and other countries to evaluate the safety, pharmacokinetics, and efficacy of tegoprubart compared to the calcineurin inhibitor tacrolimus. The BESTOW trial’s primary endpoint is designed to test the potential superiority of tegoprubart vs. tacrolimus in post kidney transplant kidney function at 12 months as measured by eGFR. The Company expects to complete enrollment at the end of 2024.

Full details on the poster presentations are below:

Title: Tegoprubart for the prevention of rejection in kidney transplant: update of emerging data from an ongoing trial
Presenter: Steve Perrin, Ph.D., President and Chief Scientific Officer, Eledon Pharmaceuticals
Poster Number: TH-PO835
Session Title: Transplantation: Clinical – I [PO2102-1] 
Session Date and Time: November 2, 2023 from 10:00 AM to 12:00 PM EDT

Following the presentation, a copy of the poster will be available on the Investor section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations. 

Conference Call

Eledon will hold a conference call today, November 2, 2023 at 5:00 p.m. Eastern Time to discuss the updated trial results. The dial-in numbers are 1-888-886-7786 for domestic callers and 1-416-764-8658 for international callers. The conference ID is 66816567. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals 

Release – Tonix Pharmaceuticals’ Vaccine Candidate, TNX-1800, Selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials

Posted on by [email protected]

Research News and Market Data on TNXP

November 02, 2023 8:00am EDTDownload as PDF

NIAID is conducting early phase clinical trials on select next generation COVID-19 vaccine candidates with the intent to identify promising vaccine candidates

TNX-1800, a live virus percutaneous vaccine candidate, is based on Tonix’s recombinant pox virus (RPV) platform

Phase 1 clinical trial of TNX-1800 expected to start in the second half of 2024

NIAID will cover the full cost of the clinical trial; Tonix will supply the vaccine candidate

CHATHAM, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial with TNX-1800 (recombinant horsepox virus, live vaccine),1 Tonix Pharmaceuticals’ vaccine candidate to protect against COVID-19.

Tonix is developing a novel vaccine platform initially targeting COVID-19, smallpox and mpox (monkeypox). The intent is to provide durable protection against severe disease and prevent forward transmission, primarily by eliciting a T-cell immune response. TNX-1800 expresses the spike protein of SARS-CoV-2, was immunogenic, well tolerated2 and showed promise in protecting animals from challenge with SARS-CoV-2 delivered directly into the lungs.3 A related horsepox-based vaccine, TNX-8011, protected animals against challenge with monkeypox virus delivered directly into the lungs.4 TNX-801 is also the vector on which TNX-1800 is based and has been shown to be >1,000-fold more attenuated than modern vaccinia virus vaccine (VACV) strains in immunocompromised mice.5 The Phase 1 trial of TNX-1800 is expected to start in the second half of 2024. NIAID will study TNX-1800 by percutaneous administration.

“We believe our novel vaccine platform technology has the potential to provide durable protection from respiratory pathogens and slow their spread,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1800 will be the first vaccine candidate using our live virus recombinant pox virus (RPV) platform technology to enter clinical trials. We hope to expand the portfolio of RPV-based vaccines to address several other known respiratory threats including smallpox, mpox and tuberculosis. We are committed to supporting NIAID in assembling a variety of vaccine platform options to ensure the availability of effective vaccines in the face of known and emerging threats. We look forward to participating in the Project NextGen initiative.”

“Project NextGen,” is an initiative by the U.S. Department of Health and Human Services (HHS) to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19. NIAID will be conducting clinical trials to evaluate several early-stage vaccine candidates. The Phase 1 study involving TNX-1800 is designed to assess safety and immunogenicity in approximately 60 healthy adult volunteers. Upon completion of the trial, NIAID and Tonix Pharmaceuticals will assess the results and determine the next steps for the development of TNX-1800.

NIAID will cover the full cost of the clinical trial, including operations and related analysis. Tonix will be responsible for providing clinical trial materials, and upon completion will have the right to rely on the findings in regulatory filings with the U.S. Food and Drug Administration (FDA) to support the approval of its COVID-19 vaccine and other vaccines based on the RPV platform.

About Project NextGen

Project NextGen is a $5 billion initiative to develop the next generation of vaccines and therapeutics to combat COVID-19. Based at the HHS and led by the Administration for Strategic Preparedness and Response’s Biomedical Advanced Research and Development Authority and the NIH’s NIAID, Project NextGen will coordinate across the federal government and the private sector to advance the pipeline of new, innovative vaccines and therapeutics into clinical trials and potential review by the U.S. Food and Drug Administration (FDA) for authorization or approval, and commercial availability for the American people. The program will focus on several areas, including mucosal vaccines, vaccines that provide broader protection against variants of concern and a longer duration of protection, pan-coronavirus vaccines, and new and more durable monoclonal antibodies.

About TNX-1800*
TNX-1800 (recombinant horsepox virus) is a live virus vaccine for percutaneous administration that is designed to express the spike protein of the SARS-CoV-2 virus and to elicit a predominant T cell response. The RPV platform is based on a horsepox vector, which is a live replicating, attenuated virus that has been shown to be >1,000-fold more attenuated than modern VACV strains in immunocompromised mice.5 Horsepox and the vaccinia vaccine viruses are closely related orthopoxviruses that are believed to share a common ancestor. Molecular analysis shows that horsepox is closer than modern vaccinia vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner. 6-9 Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice.4,6 The current formulation is a frozen liquid, but we believe that future lyophilized versions can be stored and shipped at standard refrigeration. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines that can be administered without sterile injection, manufactured using conventional cell culture systems with the potential for mass scale production, and packaged in multi-dose vials. Moreover, we believe the low dose of TNX-1800 makes this technology amenable for future implementation in microneedle delivery systems.

About TNX-801*
TNX-801 (recombinant horsepox virus) is a live virus vaccine based on horsepox4-7 in pre-clinical development to prevent smallpox and mpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox.4 Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against mpox disease and smallpox.10 Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1 /2 study and the overall clinical development plan. The Phase 1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance of an IND. More than 30,000 people have contracted mpox in the U.S. so far during the 2022-23 epidemic,11 The recent cluster of mpox in Chicago revealed breakthrough cases of mpox in individuals who had been vaccinated with the currently authorized non-replicating vaccine, which is administered in two doses.12 In contrast, TNX-801 is delivered percutaneously with only one dose and therefore may achieve higher rates of community protection by eliminating drop-out between doses and limiting forward transmission. Moreover, relying on only one approved mpox vaccine at present is a risk for the global supply chain that has already led to insufficient availability of vaccines to meet global health needs, especially in Africa. TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment for chronic migraine, and enrollment has been completed in a Phase 2 proof-of-concept study with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. 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 fourth quarter of 2023. Tonix’s rare disease development 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 development 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 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.

1 TNX-1800 and TNX-801 are experimental new vaccines and have not been approved for any indication.
2 Awasthi, M. et al. Viruses. 2023. 15(10):2131.
3 Awasthi, M. et al. BioRxiv. 2023.
4 Trefry S, et al. BioRxiv. 2023.
5 Noyce RS, et al. Viruses. 2023. 15(2):356.
6 Jenner E. “An Inquiry Into the Causes and Effects of the Variole Vaccinae, a Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire and Known by the Name of the cow‐pox.” London: Sampson Low, 1798.
7 Noyce RS, et al. PloS One. 2018. 13(1):e0188453.
8 Schrick L et al. N Engl J Med. 2017. 377:1491-1492.
9 Tulman ER, et al. J Virol. 2006. 80(18):9244-58.
10 TNX-801 PR pre-IND meeting August 20, 2023: https://ir.tonixpharma.com/news-events/press-releases/detail/1417/tonix-pharmaceuticals-announces-results-of-pre-ind-meeting
11 McQuiston JH, et al. MMWR Morb Mortal Wkly Rep. 2023. 72:547–552.
12 Centers for Disease Control. MMWR Morb Mortal Wkly Rep. 2023. 72(25);696-698.

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; risks related to the failure to successfully market any of our products; 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.

Investor Contact

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

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

Media Contact

Ben Shannon
ICR Westwicke
[email protected]
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released November 2, 2023

Release – Ocugen to Host Conference Call on Thursday, November 9 at 8:30 A.M. ET To Discuss Business Updates and Third Quarter 2023 Financial Results

Posted on by [email protected]

Research News and Market Data on OCGN

November 2, 2023

PDF Version

MALVERN, Pa., Nov. 02, 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 it will host a conference call and live webcast to discuss the Company’s third quarter 2023 financial results and provide a business update at 8:30 a.m. ET on Thursday, November 9, 2023.

Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 1787631
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

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 X and LinkedIn.

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

Contact:
Tiffany Hamilton
Head of Communications
[email protected]