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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.

Demystifying Enterprise Value: Unlocking Opportunities in the Stock Market

Posted on by phoffman@channelchek.com

Why Some Investors Evaluate a Stock Using Enterprise Value vs. Market Cap

Stock selection between different companies is always an apples to oranges comparison – even when the companies are in the same industry. But uncovering comparative value among the universe of stocks and other investment options is fundamental to successful investing. So successful stock market investors must sift for certain criteria, these filters are often financial measures. While data such as Earnings Per Share and P/E ratio get a  lot of attention, other metrics may help investors sort and filter to create their watch list, as some companies move toward the investor’s buy list. One of these is Enterprise Value in comparison to Market Capitalization.

Understanding Enterprise Value

Enterprise value (EV) is the total value of a company, defined in terms of its financing. It includes the current market capitalization (share price x shares outstanding) and compares it to the cost to pay off debt, then adds in asset values. The below calculation results in establishing  the company’s enterprise value, indicating what one might think should be the minimum needed to buy the company.

EV=Market Cap+Debt-Cash

The result can be thought of as the potential cost to acquire a business based on the company’s capital structure. As a concept, enterprise value gives you a realistic starting point for what one would need to spend to acquire a public company outright.  In reality, it typically takes a premium to EV for an acquisition offer to be accepted.

Trading Below Enterprise Value

When a company is trading below its enterprise value, it suggests that the market is valuing the company at a price lower than what its underlying assets would be worth if sold separately. In some circumstances, This situation presents investors with potential opportunities and indicates that further research and investigation may be prudent.

A popular example of a company that has traded below EV, or less than the net of its assets and debt, is Apple. The company has had on its books massive amounts of cash, along with longer-term assets, the value less any debt is higher than the market cap (Outstanding Shares x Price Per Share). 

Looking for Potential Buys

There are times when it may be worth considering an investment in a company that is trading below its enterprise value:

Temporary Market Pessimism: Companies may experience short-term setbacks, negative market sentiment, or sector-wide pessimism that leads to their stock price trading below enterprise value. It is important to assess whether the company’s fundamental strengths remain intact despite these challenges. If the negative sentiment appears temporary and the company is expected to rebound, it could be a window of opportunity.

Mispricing and Market Inefficiencies: The stock market is less than perfectly efficient, and mispricings do occur. Investors who identify stocks trading below enterprise value due to market inefficiencies can potentially capitalize on these pricing discrepancies. The investor may have to roll up their sleeves to do more analysis to determine whether the undervaluation is based on actual fundamental weaknesses or if it is a result of temporary market inefficiencies.

Asset-Rich Companies: Companies with significant tangible or intangible assets, such as real estate, patents, or intellectual property, may trade below enterprise value. Investors may find these stocks attractive as the underlying assets can provide a margin of safety and potential upside. Assessing the value and potential monetization of these assets is crucial before considering an investment.

In the case of Apple above, cash is easier to evaluate than real estate, patents, or other assets.

Considering Sellling

While stocks trading below enterprise value can present attractive opportunities, there are circumstances when it may be wise to consider selling.

Fundamental Deterioration: If a company’s underlying financials are weakening, for example, declining sales, increasing debt levels, or increased costs of doing business could indicate a problem. It is important to evaluate whether the company’s operational challenges are likely to persist, as this could impact its ability to sustain value.

Industry Decline or Structural Issues: Some companies trade below enterprise value due to broader industry decline or structural issues specific to the company. If the industry’s prospects are exoeriencing prolonged weakening, or the company faces inherent challenges that limit its growth potential, it may be prudent to sell the stock, even if it appears undervalued based on enterprise value alone.

Take Away

Understanding enterprise value and using it while sifting through opportunities could help bring stocks to the surface that one may not have considered.  

Using EV as an evaluation tool is not a slam dunk, if investing was that easy we’d all be wealthier. However it is a good starting point to isolate stocks and then evaluate why they may be trading below EV. Is it warranted, is it unwarranted?

Let Channelchek be your data source for small and microcap stocks, many of which can be found to be trading below enterprise value. Sign-up for a no-cost account and gain access to information to over 6,000 less talked about companies as well as insightful daily emails.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.investopedia.com/terms/e/enterprisevalue.asp

The Week Ahead – Debt Ceiling, Beige Book, and Employment

Posted on by phoffman@channelchek.com

The Holiday Shortened Trading Week Started with Positive Market News

It’s a four-day trading week in the US as the calendar changes from May to June. The US stock and bond markets will open on Tuesday knowing a government debt default is now likely averted as President Biden and House Speaker McCarthy reached an agreement Sunday on a deal to raise the nation’s debt ceiling. They have ensured the citizenry they have enough support in Congress to pass the measure this coming week. As far as economic reports, jobs and the labor market will be in the spotlight.

The market is focused on the labor market because Fed policymakers are paying attention to jobs numbers to determine if conditions are so strong they may indicate wage inflation or if they weakened and not strong enough to withstand another rate hike at the June 13-14 FOMC meeting.

Tuesday 5/30

•             9:00 AM ET, FHFA House Price Index. While interest rates have risen, housing prices have been flat to up. Continued demand caused prices to increase by .5% in February, it is expected prices rose again in March by a .3%.

•             10:00 AM ET, the Consumer Confidence index has been sinking and is expected to sink further in May to 100.0 from April’s 101.3. If you recall, April was much weaker than expected, reflecting a sharp decline in job and income expectations.

•             1:00 PM ET, Thomas Barkin is the CEO of the Richmond Federal Reserve district. In light of the PCE inflation indicator late last week and statements by Fed Chair Powell the Friday before, insight into thinking from FOMC members could move market sentiment.

Wednesday 5/31

•             8:50 AM ET, Susan Collins is the CEO of the Richmond Federal Reserve District. Comments by Fed district CEOs may get heightened attention this week as the market looks for clues as to what monetary policy changes may occur from the FOMC meeting in two weeks.

•             9:45 AM ET, The Chicago PMI is expected to fall in May to 47.0 versus 48.6 in April which was the eighth straight month of sub-50 contraction. Above 50 indicates economic expansion, and below 50 reflects a receding economy.

•             10:00 AM ET, Job Openings and Labor Turnover (JOLTS) have been declining. Forecasters put April’s openings at 9.35 million.

•             1:30 PM ET, Patrick Harker is the CEO of the Federal Reserve Bank of Philadelphia. He will be speaking. 

•             2:00 PM ET, If volatility sets in for the last two hours of trading on Wednesday, it may be because the Fed’s Beige Book is released. This report outlines the economic conditions in each of the Federal Reserve Districts. The FOMC uses the contents as a basis for its decision-making.

•             3:00 PM ET, Farm Prices may not be the most awaited for inflation indicator, but it is important as it is a leading inflation indicator. Agricultural prices for April are expected to have risen by 1.3% month-over-month. These increases will work their way into the Producer Price Index (PPI) and the Consumer Price Index (CPI).

Thursday 6/1

•            8:30 AM ET, Jobless claims for the May 27 week are expected to come in at 235,000 versus 229,000 in the May 20 week, which was lower than expected but followed 248,000 in the prior week.•             

•             8:30 AM ET, Released will be the second estimate for first-quarter Nonfarm Productivity. It is expected to remain the same as the first estimate, at minus 2.7 percent.

•             10:00 AM ET, The Institute for Supply Management (ISM) Manufacturing Index has been contracting over the last six months. May’s consensus is 47.0 versus April’s 47.1.

•             11:00 AM ET, The Energy Information Administration’s weekly update on petroleum inventories in the US is expected to show a decline of 12.5 million barrels.

•             1:00 PM ET, Patrick Harker is the CEO of the Federal Reserve Bank of Philadelphia. He will be speaking. 

•             4:30 PM ET, The Fed’s Balance Sheet report tells unveils if the Fed has been on track with monetary policy initiatives like quantitative Tightening (QT) and if the troubled bank outlets are getting more or less use. Obviously, this has been getting much more scrutiny by investors.

Friday 6/2

•             8:30 AM ET, The Employment Situation report is supposed to show a 180,000 rise is the call for nonfarm payroll growth in May versus 253,000 in April. Average hourly earnings in May are expected to rise 0.3 percent on the month for a year-over-year rate of 4.4 percent; these would compare with 0.5 and 4.4 percent in April, which were higher than expected. May’s unemployment rate is expected to edge higher to 3.5 percent versus April’s 3.4 percent, which was two-tenths lower than expected.

What Else

Look for a vote on the debt ceiling that is likely to pass both houses of Congress and be signed into law quickly this week.

Artificial intelligence, or AI, has been in the news at an escalating pace. While most agree it can make life better, there are also fears that if not governed, it can cause devastating problems. The White House is asking for input and comments before 5pm July 7. Get more information here.

On Tuesday May 30th and Wednesday May 31st, Tonix Pharmaceutical Holdings will be in South Florida presenting to investors as part of our Meet the Management Series. If you’d like to attend one of these roadshows, presented by Senior Management of Tonix, go here for more information.

Paul Hoffman

Managing Editor, Channelchek

Sources:

https://us.econoday.com/byweek.asp?cust=us

https://www.whitehouse.gov/wp-content/uploads/2023/05/OSTP-Request-for-Information-National-Priorities-for-Artificial-Intelligence.pdf

Noble/Channelchek  “Meet the Management” Roadshow Schedule

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

Seanergy Maritime (SHIP) – Results generally in line once one-time gain removed

Posted on by cpereira@noblefcm.com


Friday, May 26, 2023

Seanergy Maritime Holdings Corp. is the only pure-play Capesize ship-owner publicly listed in the US. Seanergy provides marine dry bulk transportation services through a modern fleet of Capesize vessels. The Company’s operating fleet consists of 17 Capesize vessels with an average age of approximately 12 years and aggregate cargo carrying capacity of approximately 3,011,083 dwt. The Company is incorporated in the Marshall Islands and has executive offices in Glyfada, Greece. The Company’s common shares trade on the Nasdaq Capital Market under the symbol “SHIP” and its Class B warrants under “SHIPZ”.

Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.

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

Revenues fell on lower shipping rates in line with expectations. Seanergy reported 2023-1Q revenues of $18.03m versus $29.7m last year but above our $17.4m projection. The average TCE rate for the quarter was $11,005/d versus $19,357/d causing the decline. Seanergy continues to receive above-market pricing due to its modern fleet and use of scrubbers. Management noted that TCE rates have risen above $18,000 allowing it to lock-in or extend ship rates. Seanergy has fixed approximately 75% of 2023-2Q available shipping days and estimates an average TCE of $18,870 based on forward rates.

Bottom line results reflect lower revenues. Seanergy reported 2023-1Q adjusted EBITDA of $3.9m versus $16.7m. Results were above our projection of $0.0m. Better-than-expected results reflect slightly higher revenues combined with slightly lower depreciation and financing costs. Seanergy reported 2023-1Q adjusted net income of ($0.3m) or ($0.02) per share. However, the company did not exclude an $8.1m gain on sale. Excluding the gain, adjusted net income would have been ($8.4m) or ($0.47) per share versus our ($12.4m) or ($0.69) per share estimate.


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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. 

LithiumBank Resources (LBNKF) – Compelling Boardwalk Preliminary Economic Assessment Provides an Excellent Starting Point

Posted on by cpereira@noblefcm.com


Friday, May 26, 2023

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Initial preliminary economic assessment. LithiumBank Resources released highlights from the initial preliminary economic assessment (PEA) for its Boardwalk lithium brine project in Alberta, Canada. The PEA was based on average annual production of 31,350 tonnes of battery grade lithium hydroxide monohydrate (LHM) over a 20-year period, an average price of US$26,000 per tonne of LHM, operating expense of US$6,807 per tonne LHM, and annual EBITDA of US$586 million. The net present value of the project is estimated at US$2.7 billion on a pre-tax basis and US$1.7 billion on an after-tax basis. The initial capital cost of the project is expected to be US$2.1 billion. The expected payback period is 4.1 years on a pre-tax basis and 4.5 years on an after-tax basis.

An excellent starting point. While the preliminary economic assessment differs in many respects to our own initial assumptions, in many ways it is in the ballpark. Importantly, it compares favorably with preliminary economic assessments of similar projects. Management has identified multiple opportunities to significantly enhance project economics that we think could increase the pre-tax net present value to over US$3.0 billion, including annual EBITDA of US$700 million.


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

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

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

Hemisphere Energy Corporation (HMENF) – Financial results reflect recent investments

Posted on by cpereira@noblefcm.com


Friday, May 26, 2023

Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.

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

Accelerated drilling is beginning to lead to strong production growth. Production rose 20% year over year and 7% quarter over quarter. After paring back drilling in 2020 when oil prices were low, the company has accelerated its drilling efforts. This has led to a doubling of production since 2020. With an active drilling program planned for the fall, look for production to show similar growth at the end of 2023 and the first quarter of 2024. 

But basin differential issues are leading to lower-than-expected pricing. Oil prices fell 19% year over year, but HME’s realized oil price fell 32%. The differential has increased in recent quarters with the last three quarters being significantly larger both in absolute terms and on a percentage basis. We would note that other western Canadian oil producers have reported a similar widening of basin differential. Whatever the reason, it is worth tracking and making adjustments in our models to reflect the widening differential.


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. 

Century Lithium Corp. (CYDVF) – From Nevada Claystone to Battery Grade Lithium Carbonate

Posted on by cpereira@noblefcm.com


Friday, May 26, 2023

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Consistency is key. Century Lithium produced lithium carbonate grading 99.87% from lithium-bearing claystone sourced from its Clayton Valley Lithium project. Several kilograms of high purity lithium carbonate were made from lithium solution produced at Century’s pilot lithium extraction facility. Following leaching and direct lithium extraction at the pilot plant, solutions were shipped to Saltworks Technologies Inc. for final processing. The results were in line with those reported in September 2022 when lithium carbonate grading 99.94% was produced.

Feasibility study expected in 2H 2023. The Clayton Valley feasibility study is expected to be completed in the second half of 2023. Major areas of the study are finished and estimates for capital and operating cost estimates have been received, including those for the chlor-alkali plant portion of the project. The estimates are being consolidated and reviewed, along with opportunities for further optimization and cost reduction.


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. 

News From the Biotech Sector has become Increasingly Rewarding

Posted on by phoffman@channelchek.com

2023 May Be the Year the Biotech Sector Cures Itself of Malaise

A pivotal point for biotech stocks seems to have been reached. It’s almost mid-2023, and barely a week goes by without news driving a biotech company’s stock price upward to gain returns that one would expect to take years to achieve in a broad basket index position. The most recent news causing this price action is yet another clinical-stage therapeutic company. Shares of PDS Biotech are up 27% since yesterday and 41% month-to date. This week’s move is attributable the company reporting positive trial results.

PDS Biotechnology (PDSB) is a clinical-stage immunotherapy company with a developing pipeline of targeted immunotherapies for cancer and infectious disease.

The impetus for the price move was the announcement of interim data from a Phase 2 trial investigating its PDS0101 in combination with Merck’s  KEYTRUDA®. The trials were in patients with unresectable, recurrent or metastatic human papillomavirus head and neck cancers.

The results were quite positive and 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.

These are highlights of the results showing the interim data of the efficacy of PDS Bio’s PDS0101 in combination with KEYTRUDA®:

The 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.

A main driver of the stock market enthusiasm can be found in the safety and efficacy results in the interim data. “This 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.”

To understand the company PDS Biotechnology better, visit the research page on Channelchek, and also review this Channelchek video that shares key information about PDSB.

The Nature of Biotech Investing

Drug discovery and development is a long, uncertain path that often takes 10–15 years, with costs that could exceed $1–2 billion for any new drug ultimately approved for clinical use. Unlike unregulated products, it’s a significant achievement for a candidate to get as far as clinical trials. Attaining interim results showing high efficacy and tolerance is a very positive sign and one that will most often cause a large price jump. Negative results can have the opposite effect.

Events that cause small-cap biotech stocks to experience significant price jumps could include:

  • Positive clinical trial results: As with PDS Biotechnology, when a small-cap biotech company releases positive clinical trial results, it can generate significant investor interest and drive up the stock price.
  • FDA approvals: Taking is a step further, FDA approvals of drugs or medical devices can significantly boost a small-cap biotech company’s stock price, as it can open up a new revenue stream for the company.
  • Partnerships and collaborations: Partnerships and collaborations with larger companies can cause a small-cap biotech stock to rise as it indicates a level of validation for the company’s technology or products, and provide needed funding to bring research and development along the lengthy timeline.
  • Acquisition rumors or deals: When rumors or announcements of an acquisition by a larger company circulate, it can cause a small-cap biotech stock to rise as investors anticipate a potential buyout premium.
  • Analyst upgrades: If an influential analyst upgrades their rating on a small-cap biotech stock, it can increase investor interest and drive up the stock price.

Companies You May Want to Watch

There is data and information on well-over 200 small-cap biotech companies on Channelchek. Below is a select group that investors may want to follow. 

Cocrystal (COCP): Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses, hepatitis C viruses and noroviruses.

Axcella (AXLA): Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using endogenous metabolic modulator compositions. The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis.

Tonix Pharmaceutical (TNXP): 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, rare disease, immunology and infectious disease product candidates.

Onconova Therapeutics (ONTX):   Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

MAIA Biotechnology (MAIA):   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 cancer patients.

Ocugen (OCGN): Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. The company impacts patient’s lives through innovation that forge new scientific paths.

PDS Biotechnology (PDSB):  This was positive news for PDS Biotech, but there work isn’t finished and they have other immunotherapy products in their pipeline based on proprietary T cell-activating technology.

Take Away

As we approach the halfway point of 2023, biotech stocks that had traded sky-high during the pandemic era had been paid far less attention to since. But the tide appears to be turning as news such as that reported by PDSB, and partnerships and even acquisitions have been on the rise.

It’s an interesting sector that, for better or worse, is barely correlated with the rest of the stock market.

Paul Hoffman

Managing Editor, Channelchek

Sources

PDS Biotechnology Press Release (May 25, 2023)

PDS Biotechnology Video

This Travel Segment Has Taken Investors Far

Posted on by phoffman@channelchek.com

Investors Have Far Fewer Reservations Against Investing in Leisure

Memorial Day Weekend in the U.S. marks the beginning of the travel season. After a few years on hiatus, as a result of Covid-19 restrictions, travel in 2023 is expected to surpass pre-pandemic numbers. While many investors are focused on the debt ceiling, less accommodative monetary policy, and looking for an entry point to invest in AI technology, post-pandemic travel plans are increasing – and the returns of some companies reflect this. One segment of the travel sector has benefitted and provided double-digit YTD stock returns. Below we discuss this segment and the potential for the future.

Travel Booking Stocks

When was the last time you went to an airline website to book a flight with them, or even a hotel for that matter? Most of us now find ourselves on a booking website when we’re planning a vacation. On these platforms, we can compare prices more easily, and if we’d like, add on extras like a car rental. Some even have proprietary package deals.

Technological advancements have created even greater efficiencies among booking and vacation travel package companies. Other positives for growth are pent-up demand, diversified revenue streams, and valuations still considered attractive. These all provide a backdrop and potential for the medium and long-term growth of the travel booking industry.

Source: Koyfin

The chart above is a year-to-date sampling of examples of stocks in this leisure segment that have outperformed the overall market (S&P 500). Below, from weakest performer to strongest, are details of each company’s unique business, market cap, and other interesting investor information:

  •  Expedia (EXPE) is a global travel company that provides a wide range of travel services, including flights, hotels, car rentals, and vacation packages.

This is a large cap stock with a current market cap of $14.33 billion, at $96.85 per share.

The company is headquartered in Seattle, Washington.

  • Booking Holdings (BKNG) is a travel company that owns a number of popular travel brands, including Booking.com, Priceline.com, and Kayak.com.

This is a large-cap stock with a current market cap of $97.61 billion, at $45.41 per share.

The company is headquartered in Norwalk, CT.

  • Allegiant Travel (ALGT) is a leisure travel company that provides travel services and other products to under-served cities in the U.S. This includes flights between vacation destinations. As of February 1, 2023, Allegiant operated a fleet of 122 Airbus A320 series aircraft.

This is a small cap stock with a current market cap of $1.85 billion, at a price of $99.96 per share.

The company is headquartered in Las Vegas, Nevada.

  • Travelzoo (TZOO) has a unique business model as it operates as an Internet media company that provides travel, entertainment, and deals from travel and leisure businesses worldwide. Publication products include the Travelzoo Top 20 email newsletter, Travelzoo emails, Travelzoo Network, Travelzoo mobile applications, Jack’s Flight Club website, Jack’s Flight Club mobile applications, and Jack’s Flight Club newsletters.

The year-to-date performance of TZOO is 10x that of the S&P 500.

In a research report dated April 28, 2023, Michael Kupinski, the senior research analyst for media and entertainment, had this to say about Travelzoo, “We believe that there is a disconnect with investors and the improved fundamentals at the company. Near current levels, the TZOO shares appear compelling, trading at 5.3 times Enterprise Value to our 2024 cash flow estimate or below the low end of the company’s 10-year and 15-year average trading ranges.” See the report here.

Current market cap is $133.05 million, at $8.69 per share.

The company is headquartered in New York, NY.

Image: “This Memorial Day weekend could be the busiest at airports since 2005” – AAA Newsroom

Take Away

Travel booking companies are well-positioned to benefit from the recovery of the overall leisure industry. Small cap travel booking companies are often more nimble and innovative than larger companies; this could give them an advantage in the travel booking market.

People are spending more money on travel. Companies like those mentioned above welcome the opening of China, allowing citizens to travel and return. In addition to the overall post-pandemic volume of business, travelers are spending more money on trips than they did before the restrictions.

Paul Hoffman

Managing Editor, Channelchek

Sources

AAA NEWSROOM (5/15/23)

Channelchek/TZOO (April 28, 2023)

Release – Tonix Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Requirement

Posted on by aweinsoff@channelchek.com

Research, News and Market Data on TNXP

May 25, 2023 4:05pm EDT

CHATHAM, N.J., May 25, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. On May 24, 2023, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix’s shares had a closing bid price at or above $1.00 per share for a minimum of 10 consecutive business days, Tonix’s stock had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2), and the matter is now closed.

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

Source: Tonix Pharmaceuticals Holding Corp.

Released May 25, 2023

Release – GeoVax to Participate in Upcoming Industry Meetings

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

Management to participate in 2023 ASCO Annual Meeting and 2023 BIO International Convention

ATLANTA, GA, May 25, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in developing human vaccines and cancer immunotherapies, announced today that its Chief Medical Officer, Kelly T. McKee, M.D., will participate in the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, in Chicago on June 2-6, 2023, and its Chairman and CEO, David Dodd, and other senior management will participate in the 2023 BIO International Convention (BIO), in Boston on June 5-8, 2023. Details for the events are as follows:

2023 ASCO Annual Meeting

Date:                            June 2-6, 2023

Location:                     McCormick Place, Chicago

Registration:              https://conferences.asco.org/am/registration

Meeting Interest:      Contact management directly at info@geovax.com

Dr. McKee will meet with interested parties at ASCO to discuss progress in the clinical development of Gedeptin®, an adenovirus-vectored bacterial purine phosphorylase, designed to locally activate a systemically administered chemotherapeutic prodrug that is currently in a Phase 2 study for the treatment of advanced head and neck cancer.

2023 BIO International Convention

Date:                            June 5-8, 2023

Location:                     Boston Convention and Exhibition Center

Registration:               https://www.bio.org/events/bio-international-convention/registration-information  

Meeting Interest:       Use BIO’s scheduling platform or contact management directly at info@geovax.com

Mr. Dodd and other senior management will host one-on-one meetings with registered attendees to explore collaborative and strategic opportunities around the company’s development portfolio, including Gedeptin® as well as GEO-CM04S1, a multi-antigenic, next-generation COVID-19 vaccine currently being investigated in two Phase 2 clinical trials.

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.

Investor Relations Contact:

Rich Cockrell

CG Capital

404-736-3838

govx@cg.capital

Release – ZyVersa Therapeutics Announces a Publication in Frontiers in Medicine Showing Direct Inflammasome Activation in Children with Juvenile Idiopathic Arthritis

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

May 25, 2023

  • Juvenile idiopathic arthritis (“JIA”), a complex autoimmune inflammatory disorder, is the most common childhood chronic rheumatic disease
  • This is the first report documenting inflammasome activation in the two most common types of JIA, oligo-articular (4 or fewer affected joints) and poly-articular (5 or more affected joints), both of which have been considered autoimmune rather than autoinflammatory diseases
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100 for treatment of various inflammatory diseases

WESTON, Fla., May 25, 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, Frontiers in Medicine, demonstrating a role for innate inflammasome activation in two of the most common types of JIA, oligo- and poly-articular, both of which are typically thought to be classical antigen-driven autoimmune conditions.

In the paper titled, “Inflammasome activation and formation of ASC specks in patients with juvenile idiopathic arthritis,” the authors reported the following:

  • Higher numbers of ASC speck-positive monocytes were detected in peripheral blood of JIA patients compared to controls
  • ASC speck-positive monocytes were detected significantly more frequently in patients with oligo-articular JIA compared to those with poly-articular JIA
  • Serum IL-1β was significantly higher in patients with JIA compared to controls
  • Higher numbers of ASC speck-positive monocytes were observed in JIA patients with an elevated titer of antinuclear antibodies (“ANA”)
  • Il-1β production from macrophages exposed to extracellular ASC specks was enhanced in serum of JIA patients with a high titer of ANA, suggesting that autoantibodies favor a secondary inflammatory response to ASC specks by macrophages

The authors stated, “We clearly discovered direct inflammasome activity ex vivo in CD14+ CD16− monocytes of oligo- and poly-articular JIA patients.” To read the article, Click Here.

“The research published in Frontiers in Medicine demonstrates the role of inflammasome activation in two of the most common types of JIA, oligo- and poly-articular, which were previously thought to be classical antigen-driven autoimmune conditions. This research provides support for the broad range of conditions that are impacted by activation of the innate immune response,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Additionally, the data demonstrating enhanced IL-1β production from macrophages exposed to extracellular ASC specks in JIA patients with a high titer of ANA supports the potential of ASC speck inhibition in helping to control inflammation in this population.”

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
kcashmere@zyversa.com
786-251-9641        

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325