Category: Health

Release – Onconova Therapeutics Reports Corporate Update And Announces Second Quarter 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ONTX

Aug 10, 2023

PDF Version

Anticipate topline results from the Phase 1 monotherapy and Phase 1/2 combination study with letrozole in Q4 2023

Plans are underway for a registrational trial with rigosertib in patients with RDEB-associated squamous cell carcinoma based on a constructive Type B FDA meeting held in June

Company to host conference call and webcast at 4:30 p.m. ET on Thursday, August 10, 2023

NEWTOWN, Pa., Aug. 10, 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 reported second quarter 2023 financial results and provided an update on recent pipeline progress. Management plans to host a conference call and live webcast at 4:30 p.m. ET today to discuss these results.

“We are very encouraged about the recent progress that the Onconova team has made for our two lead programs, narazaciclib, a differentiated multikinase CDK4/6 inhibitor targeting proteins involved in resistance pathways, and rigosertib, a cell signaling inhibitor, over the last few months, while effectively managing our financial resources. In addition, we are pleased that Victor Moyo, M.D., a highly experienced and successful clinical researcher and drug developer, has agreed to join the Company as Consulting Chief Medical Officer. We look forward to sharing several important updates in the coming months,” said Steve Fruchtman, M.D., President and Chief Executive Officer.

Dr. Fruchtman continued, “For narazaciclib, our efforts have been dedicated to completing a Phase 1 program and defining a recommended Phase 2 dose to support evaluation of narazaciclib in a randomized trial. Onconova believes this CDK4/6 compound has the potential to provide differentiated efficacy based on targeting proteins that have been implicated in resistance mechanisms and the potential for an improved safety profile. We are pleased to see target engagement based on an assay measuring proliferation. We expect to report the results from our Phase 1 monotherapy and Phase 1/2 combination study with letrozole in Q4 2023. The readout will include safety, pharmacokinetics and the definition of a recommended Phase 2 dose.”

Dr. Fruchtman concluded, “For rigosertib, we continue to believe this rigosertib’s unique action on cell signaling pathways, including K-RAS and PLK-1, combined with an acceptable safety profile, could position it as an attractive anti-cancer agent. In June, we had a constructive Type B meeting with the FDA for the use of rigosertib monotherapy in the lead, ultra-rare indication of RDEB-associated squamous cell carcinoma. Based on that meeting and the impressive clinical responses in previously refractory patients we have seen and presented at major medical meetings, we plan to design a registrational trial and will look to provide an update on next steps in H1 2024. In the meantime, we continue to support two investigator sponsored studies for rigosertib, underway in melanoma and KRAS mutated non-small cell lung cancer which includes any KRAS mutation that may be present.”

Second Quarter Financial Results
Cash and cash equivalents as of June 30, 2023, were $29.7 million, compared to $38.8 million as of December 31, 2022. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business into the second quarter of 2024.

Research and development expenses were $2.5 million for the second quarter of 2023, compared with $2.0 million for the second quarter of 2022.

General and administrative expenses were $2.2 million for the second quarter of 2023, compared with $2.1 million for the second quarter of 2022.

Net loss for the second quarter of 2023 was $4.3 million, or $0.20 per share on 21.0 million weighted shares outstanding, compared with a net loss of $4.0 million, or $0.19 per share for the second quarter of 2022 on 20.9 million weighted shares outstanding.

Conference Call and Webcast Information
Interested parties who wish to participate in the conference call may do so by dialing:

  • (800) 715-9871 for domestic and
  • (646) 307-1963 for international callers and
  • Using conference ID 9506701

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the Company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.

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 include proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

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

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include 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 and 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-sponsored trials, 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
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

ONCONOVA THERAPEUTICS, INC.   
Condensed Consolidated Balance Sheets   
(in thousands)   
 June 30, December 31,
  2023   2022 
Assets(unaudited)  
Current assets:   
Cash and cash equivalents$29,729  $38,757 
Receivables 17   29 
Prepaid expenses and other current assets 704   561 
Total current assets 30,450   39,347 
Property and equipment, net 17   24 
Other non-current assets 1   1 
Total assets$30,468  $39,372 
    
Liabilities and stockholders’ equity   
Current liabilities:   
Accounts payable$5,071  $3,860 
Accrued expenses and other current liabilities 3,369   3,960 
Deferred revenue 226   226 
Total current liabilities 8,666   8,046 
Deferred revenue, non-current 2,904   3,017 
Total liabilities 11,570   11,063 
    
Stockholders’ equity:   
Preferred stock –   – 
Common stock 210   209 
Additional paid in capital 492,424   491,816 
Accumulated other comprehensive loss (28)  (33)
Accumulated deficit (473,708)  (463,683)
Total stockholders’ equity 18,898   28,309 
Total liabilities and stockholders’ equity$30,468  $39,372 
    
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share amounts)
        
 Three Months Ended June 30, Six months months ended June 30,
  2023   2022   2023   2022 
        
Revenue$57  $57  $113  $113 
Operating expenses:       
General and administrative 2,211   2,139   4,324   4,325 
Research and development 2,456   2,038   6,536   4,040 
Total operating expenses 4,667   4,177   10,860   8,365 
Loss from operations (4,610)  (4,120)  (10,747)  (8,252)
        
Change in fair value of warrant liability –   –   –   – 
Other income, net 360   96   722   106 
Net loss (4,250)  (4,024)  (10,025)  (8,146)
Net loss per share of common stock, basic and diluted$(0.20) $(0.19) $(0.48) $(0.39)
Basic and diluted weighted average shares outstanding 20,979,766   20,904,085   20,970,022   20,904,085 

Onconova Therapeutics (ONTX) – Clinical Trials Make Expected Progress In 2Q23

Posted on by cpereira@noblefcm.com


Friday, August 11, 2023

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. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include 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, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

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.

Incremental Progress Reported During 2Q23. Onconova reported a 2Q23 loss of $4.3 million or $(0.20) per share. R&D expense of $2.5 million was lower than our estimate of $4.5 million, attributed to previous completion of clinical trial start-up costs. We expect clinical costs to rise in coming quarters as patients are accrued and have adjusted our quarterly estimates. We now expect the $29.7 million cash balance to last through 2Q24.

Narazaciclib Makes Progress In Endometrial Cancer.  A Phase 1/2 clinical trial testing the combination of narazaciclib with letrozole (Femara, from Novartis) in LGEEC (low grade endometrioid endometrial cancer) began treating patients in 1Q23. Onconova plans to announce results in 4Q23 including safety, pharmacokinetics, and a recommended Phase 2 dose. The Phase 2 trial is planned for 1H24 as a randomized trial against standard therapy.


Get the Full Report

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

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

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

Release – GeoVax Announces First Patients Vaccinated in Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients with Chronic Lymphocytic Leukemia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Seeking Improved Immune Response vs mRNA Vaccine

Full Patient Enrollment Expected Within Six Months

ATLANTA, GA, August 10, 2023 — GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that vaccinations have begun in an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355) of GEO-CM04S1 in patients with chronic lymphocytic leukemia (CLL), being conducted at City of Hope National Medical Center.

Despite a high vaccination rate, CLL patients may be at high risk for lethal COVID-19 infection due to poor immune response to currently available vaccines. The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone to carry SARS-CoV-2 virus antigens that may be more effective at inducing COVID-19 immunity in patients with poor humoral immune responses since MVA strongly induces T cell expansion even in the background of immunosuppression. By targeting both the spike (S) and nucleocapsid (N) protein antigens, GEO-CM04S1 broadens the specificity of the immune responses and protects against the loss of efficacy associated with current vaccines due to the significant sequence variation observed with the spike antigen.

The study is examining the use of two injections of GEO-CM04S1, three months apart, to assess immune responses in these vulnerable patients, with an mRNA vaccine (currently, the Pfizer-BioNTech Bivalent vaccine) as the control arm. Participants will be randomized 1:1 to receive two boosters with either the GEO-CM04S1 or the control vaccine. The primary immune response outcome will be assessed at 56 days following the first booster injection. Up to 40 participants in each arm will be vaccinated, with immune responses evaluated and compared at the interim and final analyses.

David Dodd, GeoVax President and CEO, stated, “We are very pleased with the rapid start for this third important study for GEO-CM04S1, which we expect will achieve full patient enrollment within six months. We believe the GEO-CM04S1 vaccine, containing the two antigens, S and N, along with the recognized antibody and cellular immune responses resulting from the MVA approach, has the potential to offer greater booster protection than that from the current vaccines in use, as well as provide a greater degree of protection within immunocompromised patients. We expect the CLL trial will add to the data coming from our other ongoing trials, confirming the potential benefit of GEO-CM04S1 in another population of immunocompromised individuals. We look forward to sharing progress reports as we advance.”

About GEO-CM04S1

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

A recent presentation of unpublished data from the open-label portion of the Phase 2 trial of GEO-CM04S1 (ClinicalTrials.gov Identifier: NCT04977024) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment) indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines. GEO-CM04S1 also continues to advance in another Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466). Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.

About 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 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. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

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

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Investor Relations Contact:

Rich Cockrell

CG Capital

404-736-3838

govx@cg.capital

Media Contact:

Susan Roberts

sr@roberts-communications.com

202-779-0929

GeoVax Labs, Inc. (GOVX) – 2Q23 Financial Report Reviews Progress During The Quarter

Posted on by cpereira@noblefcm.com


Thursday, August 10, 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 Continues To Make Clinical and Preclinical Progress. GeoVax Labs reported a 2Q23 loss of $5.9 million or $(0.22) per share and reviewed progress made during the quarter. The company continues to enroll patients in the Gedeptin Phase 1/2 trial in head and neck cancer, as well as its CM04S1 Phase 2 clinical trials in immunocompromised patients and as a second-generation booster against COVID-19.

Interim Gedeptin Data Was Presented. As discussed in our July 11 Research Note, GeoVax presented interim data from the Phase 1/2 trial testing Gedeptin in head and neck cancer. The presentation included the first 8 patients out of the planned enrollment of 10 patients. Gedeptin achieved Stable Disease in 5 out of 7 evaluable patients, according to RECIST 1.1 criteria. Laboratory measurements showed evidence of successful delivery of the gene, its activation, and immunological markers that were consistent with the expected tissue response.


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. 

Lab-Grown ‘Ghost Hearts’ Work to Solve Organ Transplant Shortage

Posted on by phoffman@channelchek.com
A ‘ghost heart’ is a pig’s heart prepared so that it can be transplanted into people. Provided by Doris Taylor

Combining a Cleaned-Out Pig Heart with a Patient’s Own Stem Cells

Heart disease is the leading cause of death worldwide. The World Health Organization estimates that 17.9 million people lose their lives to it each year, accounting for 32% of global deaths.

Doris Taylor is a scientist working in regenerative medicine and tissue engineering. Her work has focused on creating personalized functioning human hearts in a lab that could rule out the need for donors. Taylor has dubbed these hearts “ghost hearts.” This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts like Doris Taylor, Regenerative Medicine Lecturer at the University of New Hampshire.

What are the biggest challenges facing organ donations today?

Currently, patients in need of a heart transplant need to join a waitlist, and hearts become available when someone else has died. Because there are not enough hearts to go around, only the very sick are put on the waitlist. The U.S. transplants about 11 hearts a day, and on a given day there are more than 3,000 people waiting for a heart.

Even when organs are successfully transplanted, it isn’t a Hollywood fairy-tale ending. A person receiving an organ transplant essentially trades one disease for other medical complications and diseases. Toxic drugs necessary to prevent rejection can cause high blood pressure diabetes, cancer and kidney failure. These are serious medical issues that also affect people emotionally, financially and physically.

About 18% of people die in the first year after a transplant.

What is the so-called “ghost heart”? How does it work?

The ghost heart is a heart whose cells have been removed. All that remains is the heart framework, or scaffolding. It’s called a ghost heart because removing the cells causes the heart to turn from red to white. A human heart wouldn’t work as a scaffold because so few are available to work with.

So my team and I went with the next best thing: a pig heart. Pig hearts are similar to human hearts in terms of their size and structure. Both have four chambers – two atria and two ventricles – responsible for pumping blood. And structures from pig hearts such as valves have been used in humans safely.

To remove the cells, the pig heart is gently washed through its blood vessels with a mild detergent to remove the cells. This process is called perfusion decellurization. The cell-free heart can then be seeded with new cells – in this case, a patient’s cells – thus forming a personalized heart.

Doris Taylor speaks at the 2023 Imagine Solutions Conference.

What role do stem cells play in creating a heart?

If you lined up the cells needed for an average-size 350-gram human heart, they would stretch for 41,000 miles. Stacked on top of one another, they would amount to 2 billion lines of cells, or enough to fill seven movie screens. But heart cells don’t divide. If they did, hearts could likely repair themselves.

Stem cells, on the other hand, do divide. They can also form into specialized cells – in this case, heart cells. Nobel Prize laureate Dr. Shinya Yamanaka discovered a method to make stem cells out of blood or skin cells from an adult. My team and I employed this method to obtain stem cells, then grew those cells into billions. After that, the team used chemicals to “differentiate” them into heart cells. We employed this method to obtain billions and billions of heart cells.

The first time I saw heart cells beating in a dish it was life-changing. But while the cells are alive and beat, they are not a heart. To be a heart, these cells need to be placed into a form that lets them become a unified organ, to mature and to be able to pump blood. In a human body, this happens during development; we had to reproduce that capacity in the lab.

In 2022, a pig heart that had been genetically engineered to reduce rejection and improve acceptance was transplanted into a human. Why is it better to build a heart from scratch using pig scaffolding instead?

Let me be clear: Any heart is better than no heart. And xenotransplantation – the process by which nonhuman animal organs are transplanted into humans – opened doors for all scientists in this field.

The patient received a pig heart that had been gene-edited. Human genes were added, and some pig genes were removed, but the heart still essentially comprised pig cells within a pig scaffold. As a result, the individual had to take anti-rejection drugs that suppressed the immune system. And, unbeknownst to doctors, the heart was carrying a pig virus that ultimately killed the patient two months following the transplant.

I believe these sorts of problems are avoided with the ghost heart. My team removes the pig cellular material from the scaffold, leaving only the protein structure and blood vessel channels behind. The proteins are so similar to human scaffold proteins they don’t appear to cause rejection.

Release – Schwazze Announces Second Quarter 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

August 9, 2023

PDF Version

Q2 Revenue of $42.4 Million; Income from Operations of $5.0 Million; Adjusted EBITDA of $13.8 Million or 33% of revenue 

Generated $2.7 Million of Operating Cash Flow 

DENVER, Colo., Aug. 9, 2023 /CNW/ – Medicine Man Technologies, Inc., operating as Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), today announced financial and operational results for the second quarter ended June 30, 2023.

   

Second Quarter 2023 Summary

For the Three Months Ended
$ in Thousands USDJune 30, 2023March 31, 2023June 30, 2022
Revenue$42,375$40,001$44,263
Gross Profit$24,519$23,033$25,156
Income from Operations$4,957$5,650$9,036
Adjusted EBITDA1$13,814$14,525$15,021
Operating Cash Flow$2,683$(880)$(13,486)
______________________________
1 Adjusted EBITDA represents earnings before interest, taxes, depreciation, and amortization, adjusted for other income, non-cash share-based compensation, one-time transaction related expenses, or other non-operating costs. The Company uses adjusted EBITDA as it believes it better explains the results of its core business.

Management Commentary

“We continued to execute on our ‘go deep’ retail strategy in the second quarter, demonstrated by our acquisitions of Everest Apothecary in New Mexico in June, as well as Standing Akimbo and Smokey’s in Colorado,” said Nirup Krishnamurthy, CEO of Schwazze. “Although it is early in the integration process and these stores have yet to ramp, in July we began to recognize synergies from bulk purchasing, introducing new product assortment, and leveraging best cultivation practices to improve yields, among other improvements. We expect to realize additional benefits as we further integrate our assets in the months ahead.

“The cannabis market environment in Colorado and New Mexico remains a challenge due to pricing pressure and license proliferation in key markets. However, we are beginning to see early signs of wholesale pricing stabilization in Colorado and are hyper-focused on customer acquisition and experience, while maintaining our brand standards and margin through targeted promotions for customers. Through these efforts, we increased market share in both Colorado and New Mexico, demonstrating the effectiveness of our operating playbook and acquisition strategy, as well as our ability to execute in a competitive environment.

“Looking ahead, we will continue to run a lean operation while implementing the Schwazze retail playbook across our markets to expand our customer base, increase labor and price optimization, and improve customer loyalty and brand penetration. We are well positioned to continue driving strong adjusted EBITDA margins and consistent cash flow generation in 2023.”

Recent Highlights

  • Completed the acquisition of Everest Apothecary in June, increasing the Company’s New Mexico operations to 32 dispensaries, four cultivation facilities, two manufacturing facilities and over 400 employees statewide.
  • Appointed Nirup Krishnamurthy as Chief Executive Officer.
  • Acquired two Colorado retail dispensaries from Smokey’s Cannabis Company.
  • Acquired Standing Akimbo, the largest medical cannabis dispensary in Colorado, and opened the Company’s first medical dispensary in Colorado Springs under the Standing Akimbo banner.
  • Ecommerce penetration in New Mexico and Colorado grew approximately 45% and 15%, respectively, compared to the first quarter of 2023 when the program was first launched.
  • Experienced 17% sequential growth of new customer loyalty members in the second quarter of 2023.

Second Quarter 2023 Financial Results

Total revenue in the second quarter of 2023 was $42.4 million compared to $44.3 million for the same quarter last year. The decrease was primarily due to lower wholesale revenue resulting from a 25% year-over-year decline in wholesale pricing and the proliferation of new licenses in key New Mexico markets, partially offset by growth from new stores compared to the prior year period.

Gross profit for the second quarter of 2023 was $24.5 million or 57.9% of total revenue, compared to $25.2 million or 56.8% of total revenue for the same quarter last year. The increase in gross margin was primarily driven by efficiency gains across retail, cultivation, and production, partially offset by the aforementioned wholesale pricing pressure.

Operating expenses for the second quarter of 2023 were $19.6 million compared to $16.1 million for the same quarter last year. The increase was primarily due to the four-wall SG&A increases associated with 27 additional stores in Colorado and New Mexico that are still ramping, as well as an increase in stock-based compensation. This was partially offset by efficiencies implemented throughout the Company’s operations.

Income from operations for the second quarter of 2023 was $5.0 million compared to $9.0 million in the same quarter last year. Net loss was $6.6 million compared to net income of $33.8 million for the second quarter of 2022, primarily driven by a $35.2 million change in the non-cash accounting revaluation of the derivative liability related to the Company’s convertible note.

Adjusted EBITDA for the second quarter of 2023 was $13.8 million or 32.6% of revenue, compared to $15.0 million or 33.9% of revenue for the same quarter last year. The decrease in adjusted EBITDA margin was primarily driven by lower revenue and higher SG&A associated with new stores that are still ramping, partially offset by improved gross margin.

As of June 30, 2023, cash and cash equivalents were $19.9 million compared to $38.9 million on December 31, 2022, while operating working capital increased by $5.8 million to $10.0 million during this period. Total debt as of June 30, 2023, was $155.4 million compared to $127.8 million on December 31, 2022.

Schwazze CFO Forrest Hoffmaster added, “In addition to our focus on top line growth, supply chain efficiencies and cash generation, we are capitalizing on our hyper-regional retail strategy with a series of cost optimization programs that are improving our cash position and margins. We have begun to see the benefit of these initiatives and expect to drive further improvements in the months ahead.”

Conference Call

The Company will conduct a conference call today, August 9, 2023, at 5:00 p.m. Eastern time to discuss its results for the second quarter ended June 30, 2023.

Schwazze management will host the conference call, followed by a question-and-answer period. Interested parties may submit questions to the Company prior to the call by emailing ir@schwazze.com.

Date: Wednesday, August 9, 2023
Time: 5:00 p.m. Eastern time
Toll-free dial-in number: (888) 664-6383
International dial-in number: (416) 764-8650
Conference ID: 70252888
Webcast: SHWZ Q2 2023 Earnings Call

The conference call will also be broadcast live and available for replay on the investor relations section of the Company’s website at https://ir.schwazze.com.

Toll-free replay number: (888) 390-0541
International replay number: (416) 764-8677
Replay ID: 252888

If you have any difficulty registering or connecting with the conference call, please contact Elevate IR at (720) 330-2829.

About Schwazze

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

Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector.

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

Forward-Looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intends,” “plans,” “strategy,” “prospects,” “anticipate,” “believe,” “approximately,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” or the negative of these terms or other words of similar meaning in connection with a discussion of future events or future operating or financial performance, although the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) regulatory limitations on our products and services and the uncertainty in the application of federal, state, and local laws to our business, and any changes in such laws; (ii) our ability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (iii) our ability to identify, consummate, and integrate anticipated acquisitions; (iv) general industry and economic conditions; (v) our ability to access adequate capital upon terms and conditions that are acceptable to us; (vi) our ability to pay interest and principal on outstanding debt when due; (vii) volatility in credit and market conditions; (viii) the loss of one or more key executives or other key employees; and (ix) other risks and uncertainties related to the cannabis market and our business strategy. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

MEDICINE MAN TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
For the Periods Ended June 30, 2023 and December 31, 2022
Expressed in U.S. Dollars

June 30,December 31,
20232022
(Unaudited)(Audited)
ASSETS
Current Assets
Cash & Cash Equivalents$19,872,099$38,949,253
Accounts Receivable, net of Allowance for Doubtful Accounts6,179,6624,471,978
Inventory33,821,28222,554,182
Notes Receivable – Current, net–11,944
Marketable Securities, net of Unrealized Loss of $1,816 and Loss of $39,270, respectively456,099454,283
Prepaid Expenses & Other Current Assets6,203,0565,293,393
Total Current Assets66,532,19871,735,033
Non-Current Assets
Fixed Assets, net Accumulated Depreciation of $7,007,889 and $4,899,977, respectively31,128,35727,089,026
Investments2,000,0002,000,000
Goodwill75,968,13094,605,301
Intangible Assets, net Accumulated Amortization of $24,981,817 and $16,290,862, respectively168,892,605107,726,718
Note Receivable – Non-Current, net1,313–
Other Non-Current Assets1,222,8051,527,256
Operating Lease Right of Use Assets23,213,50418,199,399
Total Non-Current Assets302,426,714251,147,700
Total Assets$368,958,912$322,882,733
LIABILITIES & STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts Payable$12,105,250$10,701,281
Accounts Payable – Related Party6,07322,380
Accrued Expenses6,398,1157,462,290
Derivative Liabilities6,538,48516,508,253
Lease Liabilities – Current4,026,5953,139,289
Current Portion of Long Term Debt6,583,3342,250,000
Income Taxes Payable14,113,4777,297,815
Total Current Liabilities49,771,32947,381,308
Non-Current Liabilities
Long Term Debt, net of Debt Discount & Issuance Costs148,861,810125,521,520
Lease Liabilities – Non-Current22,096,23217,314,464
Deferred Income Taxes, net178,031502,070
Total Non-Current Liabilities171,136,073143,338,054
Total Liabilities$220,907,402$190,719,362
Stockholders’ Equity
Preferred Stock, $0.001 Par Value. 10,000,000 Shares Authorized; 86,994 Shares Issued and
86,994 Shares Outstanding as of June 30, 2023 and 86,994 Shares Issued and 86,994 Shares
Outstanding as of December 31, 2022.8787
Common Stock, $0.001 Par Value. 250,000,000 Shares Authorized; 71,730,449 Shares Issued
and 70,590,451 Shares Outstanding as of June 30, 2023 and 56,352,545 Shares Issued and
55,212,547 Shares Outstanding as of December 31, 2022.71,73056,353
Additional Paid-In Capital201,116,605180,381,641
Accumulated Deficit(51,103,785)(46,241,583)
Common Stock Held in Treasury, at Cost, 920,150 Shares Held as of June 30, 2023 and 920,150
Shares Held as of December 31, 2022.(2,033,127)(2,033,127)
Total Stockholders’ Equity148,051,510132,163,371
Total Liabilities & Stockholders’ Equity$368,958,912$322,882,733

MEDICINE MAN TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME AND (LOSS)
For the Three and Six Months Ended June 30, 2023 and 2022
Expressed in U.S. Dollars

For the Three Months EndedFor the Six Months Ended
June 30,June 30,
2023202220232022
(Unaudited)(Unaudited)(Unaudited)(Unaudited)
Operating Revenues
Retail$38,098,957$38,138,799$73,919,068$64,664,515
Wholesale4,274,4836,080,8438,333,40811,288,231
Other1,66043,750123,56088,200
Total Revenue42,375,10044,263,39282,376,03676,040,946
Total Cost of Goods & Services17,856,05019,106,94434,824,32039,946,995
Gross Profit24,519,05025,156,44847,551,71636,093,951
Operating Expenses
Selling, General and Administrative Expenses8,838,9366,666,04419,054,84713,521,755
Professional Services487,8601,516,5441,675,2244,101,016
Salaries7,389,1727,240,36813,154,16512,537,145
Stock Based Compensation2,845,691697,8423,060,2351,688,925
Total Operating Expenses19,561,65916,120,79836,944,47131,848,841
Income from Operations4,957,3919,035,65010,607,2454,245,110
Other Income (Expense)
Interest Expense, net(7,890,439)(7,489,205)(15,636,294)(14,791,459)
Unrealized Gain (Loss) on Derivative Liabilities1,468,08336,705,7649,969,76823,288,292
Other Loss–––7
Unrealized Gain (Loss) on Investments–(5,264)1,816(13,813)
Total Other Income (Expense)(6,422,356)29,211,295(5,664,710)8,483,027
Pre-Tax Net Income (Loss)(1,464,965)38,246,9454,942,53512,728,137
Provision for Income Taxes5,142,5594,405,9629,804,7375,665,856
Net Income (Loss)$(6,607,524)$33,840,983$(4,862,202)$7,062,281
Less: Accumulated Preferred Stock Dividends for the Period(2,353,883)(1,766,575)(4,383,277)(3,510,019)
Net Income (Loss) Attributable to Common Stockholders$(8,961,407)$32,074,408$(9,245,479)$3,552,262
Earnings (Loss) per Share Attributable to Common Stockholders
Basic Earnings (Loss) per Share$(0.15)$0.65$(0.16)$0.07
Diluted Earnings (Loss) per Share$(0.15)$0.24$(0.16)$0.03
Weighted Average Number of Shares Outstanding – Basic60,538,31749,178,49457,999,46149,178,494
Weighted Average Number of Shares Outstanding – Diluted60,538,317133,481,66757,999,461133,481,667
Comprehensive Income (Loss)$(6,607,524)$33,840,983$(4,862,202)$7,062,281

MEDICINE MAN TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Six Months Ended June 30, 2023 and 2022
Expressed in U.S. Dollars

For the Six Months Ended
June 30,
20232022
(Unaudited)(Unaudited)
Cash Flows from Operating Activities:
Net Income (Loss) for the Period$(4,862,202)$7,062,281
Adjustments to Reconcile Net Income (Loss) to Cash for Operating Activities
Depreciation & Amortization10,826,2891,553,817
Non-Cash Interest Expense1,992,2802,165,366
Non-Cash Lease Expense3,316,1714,705,059
Deferred Taxes(324,039)–
Change in Derivative Liabilities(9,969,768)(23,288,292)
Amortization of Debt Issuance Costs843,025843,025
Amortization of Debt Discount4,088,3193,590,017
(Gain) Loss on Investments, net(1,816)13,813
Stock Based Compensation3,060,235776,917
Changes in Operating Assets & Liabilities (net of Acquired Amounts):
Accounts Receivable(923,614)(1,689,914)
Inventory(5,937,100)3,924,172
Prepaid Expenses & Other Current Assets(909,663)(5,219,898)
Other Assets304,451(185,589)
Change in Operating Lease Liabilities(2,661,202)(8,873,051)
Accounts Payable & Other Liabilities(3,853,458)5,922,458
Income Taxes Payable6,815,662(1,163,770)
Net Cash Provided by (Used in) Operating Activities1,803,570(9,863,589)
Cash Flows from Investing Activities:
Collection of Notes Receivable10,631–
Cash Consideration for Acquisition of Business, net of Cash Acquired(15,834,378)(56,875,923)
Purchase of Fixed Assets(4,704,093)(7,076,116)
Purchase of Intangible Assets–(2,825)
Net Cash Provided by (Used in) Investing Activities(20,527,840)(63,954,864)
Cash Flows from Financing Activities:
Payment on Notes Payable(750,000)–
Proceeds from Issuance of Common Stock, net of Issuance Costs397,1161,280,660
Net Cash Provided by (Used in) Financing Activities(352,884)1,280,660
Net (Decrease) in Cash & Cash Equivalents(19,077,154)(72,537,793)
Cash & Cash Equivalents at Beginning of Period38,949,253106,400,216
Cash & Cash Equivalents at End of Period$19,872,099$33,862,423
Supplemental Disclosure of Cash Flow Information:
Cash Paid for Interest$10,931,090$9,004,575

MEDICINE MAN TECHNOLOGIES, INC.
ADJUSTED EBITDA RECONCILIATION (NON-GAAP)
For the Three and Six Months Ended June 30, 2023 and 2022
Expressed in U.S. Dollars

For the Three Months EndedFor the Six Months Ended
June 30,June 30,
2023202220232022
Net Income (Loss)$(6,607,524)$33,840,983$(4,862,202)$7,062,281
Interest Expense, net7,890,4397,489,20515,636,29414,791,459
Provision for Income Taxes5,142,5594,405,9629,804,7375,665,856
Other (Income) Expense, net of Interest Expense(1,468,083)(36,700,500)(9,971,584)(23,274,486)
Depreciation & Amortization3,865,1902,960,60310,478,0045,506,627
Earnings Before Interest, Taxes, Depreciation and
Amortization (EBITDA) (non-GAAP)$8,822,581$11,996,253$21,085,249$9,751,737
Non-Cash Stock Compensation2,845,691697,8423,060,2351,688,925
Deal Related Expenses733,7181,656,5291,929,5203,913,463
Capital Raise Related Expenses–41,31235,068605,632
Inventory Adjustment to Fair Market Value for
Purchase Accounting–246,613–6,507,047
Severance185,68144,537304,11749,102
Retention Program Expenses115,000–395,632–
Employee Relocation Expenses26,46833252,17519,110
Other Non-Recurring Items1,085,005338,0501,477,028334,632
Adjusted EBITDA (non-GAAP)$13,814,144$15,021,468$28,339,024$22,869,648
Revenue42,375,10044,263,39282,376,03676,040,946
Adjusted EBITDA Percent32.6 %33.9 %34.4 %30.1 %

MEDICINE MAN TECHNOLOGIES, INC.
OPERATING WORKING CAPITAL RECONCILIATION (NON-GAAP)
For the Periods Ended June 30, 2023 and December 31, 2022
Expressed in U.S. Dollars

June 30,December 31,
20232022
Current Assets$66,532,198$71,735,033
Less: Cash & Cash Equivalents(19,872,099)(38,949,253)
Adjusted Current Assets (non-GAAP)46,660,09932,785,780
Current Liabilities$49,771,329$47,381,308
Less: Derivative Liabilities(6,538,485)(16,508,253)
Less: Current Portion of Long Term Debt(6,583,334)(2,250,000)
Adjusted Current Liabilities (non-GAAP)36,649,51028,623,055
Operating Working Capital (non-GAAP)$10,010,589$4,162,725

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SOURCE Schwazze

Release – GeoVax Reports 2023 Second Quarter Financial Results and Provides Corporate Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

  • Last updated: 09 August 2023 20:03
  • Created: 09 August 2023 16:15
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Progress and Promising Outlook for Gedeptin® and GEO-CM04S1

Phase 2 GEO-CM04S1 Clinical Trial Initiated for Patients with Chronic Lymphocytic Leukemia

Company to Host Conference Call and Webcast Today at 4:30 p.m. ET

Atlanta, GA, August 9, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing vaccines and immunotherapies against infectious diseases and cancers, today announced its financial results for the quarter ended June 30, 2023, and recent corporate highlights.

David Dodd, GeoVax’s Chairman and CEO, commented, “The first half of 2023 has been highly productive for GeoVax, with continued enrollment in, and positive interim clinical data presented for, both of our lead programs, Gedeptin® and GEO-CM04S1. We are also excited to have recently announced the start of an important third Phase 2 clinical study for GEO-CM04S1, in patients with chronic lymphocytic leukemia. Our next-generation COVID-19 vaccine, which utilizes an MVA-vector containing the two antigens, S and N, induces broad and durable antibody and cellular immune responses that we believe has the potential to offer a more robust, durable degree of protection than the current authorized COVID-19 vaccines, particularly in highly vulnerable immunocompromised patients.”

Mr. Dodd continued, “In addition to clinical progress, there are other notable achievements that set the stage for our future success. We have made significant progress in developing a high-yield, high-capacity, continuous avian cell line system for manufacturing our MVA-based vaccines and immunotherapies, and we recently partnered with Advanced Bioscience Laboratories, Inc. to support current Good Manufacturing Practices production of our MVA-based products through late-stage development and eventual commercialization. Additionally, the recent expansion of our GEO-CM04S1 rights to include development for Mpox and smallpox adds to other rights we previously secured from the NIH covering preclinical, clinical, and commercial uses of the NIH-MVA. This provides a compelling opportunity to leverage our MVA-based vaccine expertise and help expand the global public health supply options available for the worldwide public health threats posed by SARS-CoV-2, Mpox and smallpox. We expect significant clinical developments and other important events during the remainder of 2023, and we look forward to continuing to share news of our progress.”

Recent Business Highlights:

  • New Clinical Trial Initiated for GEO-CM04S1. In July, GeoVax announced the start of a Phase 2 COVID-19 vaccine booster investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355) in patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. As a result of their medical status, CLL patients are largely unable to mount a sufficient antibody response to the mRNA vaccines. The trial is expected to enroll approximately 80 patients, comparing GEO-CM04S1 vs the Pfizer/BioNTech Bivalent vaccine. Completion of patient enrollment is expected within approximately six months. This investigator-initiated trial is being primarily funded by a private family foundation with GeoVax supporting the analysis of samples, so it is expected to have minimal impact on the Company’s balance sheet.
  • Gedeptin® Clinical Trial Data. Interim data from the Phase 1/2 clinical trial of Gedeptin® was presented at the American Association for Cancer Research (AACR) and the American Head and Neck Society (AHNS) joint Head and Neck Cancer Conference in July. The ongoing Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT03754933) is evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck cancers whose tumor(s) are accessible for injection, and who have no curable treatment options. The poster presentation, which can be viewed here, highlighted data from 8 patients enrolled in the study to date, noting no dose-limiting toxicities or serious adverse events definitively attributable to treatment, with impairment of tumor growth in targeted lesions observed in 5 of 7 patients (one patient remaining under study).

The study is being funded in part by the U.S. Food and Drug Administration (FDA) pursuant to its Orphan Products Clinical Trials Grants Program. The FDA has also granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of the mouth, salivary gland, and other oral cavities. GeoVax expects to complete the current trial by year-end 2023, after which expanded development of Gedeptin is anticipated, both as monotherapy and combination therapy in conjunction with other therapies to potentially include immune checkpoint inhibitors, angiogenesis inhibitors, radiation, chemotherapy, etc.

  • GEO-CM04S1 Clinical Trial Data. In April, unpublished data from the open-label portion of the Phase 2 trial of GEO-CM04S1 in patients with hematologic cancers receiving cell transplants or CAR-T therapy (gov Identifier: NCT04977024) was presented during the 23rd Annual World Vaccine Congress. This trial is investigating GEO-CM04S1 in a profoundly immunosuppressed patient population due to their pre-transplant induction regimens. The preliminary analysis indicates GEO-CM04S1 is highly immunogenic in these patients, inducing both neutralizing antibodies and T cell responses, which the Company believes are important to confer protection against severe COVID-19. These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines and is anticipated to include multiple sites both within and outside the U.S.

Further underscoring the need for next-generation COVID-19 vaccines such as GEO-CM04S1, GeoVax scientists co-authored an article titled, “MVA-Vectored Universal Beta-Coronavirus Vaccine Design & Development”, published in the June 2023 issue of the online journal Vaccine Insights. The article, accessible here, provides expert insight into the emergence of SARS-CoV-2 (COVID-19), the risk of new “spillover events” from animal hosts, and how this risk can be addressed proactively. Regarding COVID-19 and its continually evolving variants, the authors describe the limitations of first-generation vaccines and the potential for MVA-vectored vaccines such as GEO-CM04S1 to overcome these limitations.

  • Mpox Vaccine Rights Added to GEO-CM04S1. In April, GeoVax expanded its rights under its license agreement with City of Hope (COH) for GEO-CM04S1, which now grants GeoVax development and commercialization rights against orthopoxviruses in addition to SARS-CoV-2. Orthopoxviruses include Mpox, smallpox, and other viruses that cause disease in humans. GEO-CM04S1, which can induce strong antibody and T cell responses against the SARS-CoV-2 virus variants, also offers the possibility of protection against Mpox and smallpox diseases, further differentiating GEO-CM04S1 as compared to current mRNA-based COVID-19 vaccines. Such attributes may be especially important in vulnerable patient populations, such as the immune-compromised, and in geographic areas where both diseases are endemic. Such a vaccine may offer a simplified vaccine regimen for protection against diseases associated with SARS-CoV-2 and orthopoxviruses.
  • GEO-MVA (Mpox and smallpox vaccine). Following the recent announcement of GeoVax acquiring the rights from NIH to develop, manufacture and commercialize MVA as a vaccine against Mpox and smallpox, the Company has advanced to active regulatory discussions related to an expedited regulatory path for registration. GeoVax is focused on being the first U.S. supplier of the vaccine, providing expanded supply options for public health worldwide.
  • Manufacturing Development Progress. In May, GeoVax announced it had entered into an agreement with Advanced Bioscience Laboratories, Inc. (ABL) to support current Good Manufacturing Practices (cGMP) production of the company’s vaccine candidates, including GEO-CM04S1. ABL, a subsidiary of Institut Mérieux, is a pure-play contract development and manufacturing organization (CDMO) specialized in the development and manufacturing of gene therapies, oncolytic viruses, and vaccine candidates. With cGMP facilities in the U.S. and Europe, ABL is well-positioned to support GeoVax’s global development programs through late-stage development and eventual commercialization.

Earlier in 2023, GeoVax announced significant progress in developing a high-yield, high-capacity, continuous avian cell line system for manufacturing its MVA-based vaccines and immunotherapies. The Company is accelerating activities towards fully implementing a proprietary, continuous cell line manufacturing system that will provide lower-cost, scalable versatility for broad MVA vaccine and immunotherapy applications. GeoVax is on course to expand MVA applications from stockpile-based solutions for niche medical markets to have the capability to respond to large-scale worldwide requirements on a timely basis.

  • Preclinical Programs. Data from recent nonhuman primate studies of GEO-MM01 against Marburg virus were presented during the 23rd Annual World Vaccine Congress. Of particular interest, immunization with GEO-MM01 conferred 80% survival in cynomolgus macaques following a lethal dose of Marburg virus. Vaccination protected nonhuman primates from viremia, weight loss, and death following challenge with a lethal Marburg virus dose. Evaluation of immune responses following vaccination demonstrated the presence of both neutralizing antibodies and functional T cells, indicating a breadth of response capable of offering significant protection.
  • Patent Portfolio Development. In July, GeoVax announced that the U.S. Patent and Trademark Office issued Patent No. 11,701,418 B2 to GeoVax, pursuant to the Company’s patent application No. 15/543,139 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) and Matrix Protein (VP40).” The claims granted by the patent generally cover GeoVax’s vector platform for expressing ebolavirus antigens in virus-like particles (VLPs) utilizing an MVA viral vector. The claims encompass multiple ebolavirus strains, including Sudan ebolavirus, Zaire ebolavirus, Taï Forest ebolavirus, and Reston ebolavirus. GeoVax previously demonstrated that a single intramuscular (IM) dose of its vaccine candidate, GEO-EM01, provided 100% protection in rhesus macaques challenged with a lethal dose of Zaire ebolavirus (EBOV). Additionally, the Company’s preclinical efficacy studies of its Sudan ebolavirus (SUDV) vaccine candidate demonstrated that a single dose of the vaccine protected 100% of small animals challenged with a lethal dose of SUDV.

Earlier in 2023, GeoVax announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for Patent Application No. 17/000,768 titled, “Method for Generating a ZIKV Immune Response Utilizing a Recombinant Modified Vaccinia Ankara Vector Encoding the NS1 Protein.” Preclinical studies demonstrated that a single dose of GEO-ZM02 provided 100% protection against a lethal dose of the Zika virus.

These patents add to the Company’s growing portfolio of wholly owned, co-owned, and in-licensed intellectual property, now standing at over 115 granted or pending patent applications spread over 24 patent families.

Financial Results

  • Net Loss: Net loss for the three months ended June 30, 2023, was $5,927,620, or $0.22 per share, as compared to $2,241,699, or $0.18 per share, for the comparable period in 2022. For the six months ended June 30, 2023, the Company’s net loss was $9,965,536 ($0.38 per share) as compared to a net loss of $4,669,214 ($0.47 per share) in 2022.
  • R&D Expenses: Research and development expenses were $4,719,728 and $7,538,917 for the three-month and six-month periods ended June 30, 2023, compared to $1,307,177 and $2,637,721 for the comparable periods in 2022, with the increases primarily due to the cost of conducting clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing materials for use in our clinical trials, additional personnel costs, technology license fees, costs of preclinical research activities and a generally higher level of activity.
  • G&A Expenses: General and administrative expenses were $1,459,093 and $2,910,518 for the three-month and six-month periods ended June 30, 2023, compared to $935,311 and $2,114,335 for the comparable periods in 2022, with the increases primarily due to higher personnel costs, investor relations consulting costs, patent costs and other expenses supportive of a higher level of activity.
  • Cash Position: GeoVax reported cash balances of $17,788,911 at June 30, 2023, as compared to $27,612,732 at December 31, 2022.

Summarized financial information is included. Further information is included in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.

Conference Call Details

Management will host a conference call scheduled to begin at 4:30 p.m. ET today, August 9, 2023, to review financial results and provide an update on corporate developments. A question-and-answer session will follow management’s formal remarks.

Domestic:              800-715-9871

International:         646-307-1963

Conference ID:      5604173

Webcast:               GeoVax Earnings Webcast

A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.

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 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. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

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

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Investor Relations Contact:

Rich Cockrell

CG Capital

404-736-3838

govx@cg.capital

FINANCIAL TABLES

Release – Multi-State Cannabis Operator, Schwazze, Continues Expansion In New Mexico With New R.Greenleaf Store Opening In Hobbs, Nm

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

August 8, 2023

PDF Version

NEO: SHWZ
OTCQX: SHWZ

DENVER, Aug. 8, 2023 /CNW/ – Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), a multi-state operating cannabis company with assets in Colorado and New Mexico, announces the grand opening of its medical and recreational dispensary, R.Greenleaf Hobbs, which opened on Saturday, August 5, 2023. The new store is located at 1901 Joe Harvey Blvd #130 in Hobbs, NM 88240. Store operating hours are 8a to 11p Monday through Saturday; 8a to 8p on Sunday.

   

The R.Greenleaf Hobbs store opening continues the Company’s expansion throughout New Mexico and comes on the heels of eight additional R.Greenleaf store openings since Schwazze’s acquisition of the retail banner in February 2022. This opening along with the recent acquisition of Everest brings Schwazze’s total number of New Mexico retail dispensaries to 33. All locations serve the needs of medical patients as well as recreational adult-use consumers.

“We are excited to be a part of the growing cannabis community in New Mexico and to open an additional R.Greenleaf dispensary in the state. The team has been hard at work preparing to serve our customers in and around the city of Hobbs offering a wide variety of quality products serviced by dedicated, knowledgeable staff,” said Ken Bair, Senior Vice President of New Mexico Retail.

Since April 2020, Schwazze has acquired, opened, or announced the planned acquisition of 62 cannabis retail dispensaries (bannered as Star Buds, Emerald Fields, R. Greenleaf, Standing Akimbo, and Everest) as well as eight cultivation facilities and three manufacturing plants across Colorado and New Mexico. In May 2021, Schwazze launched its Biosciences division, and in August 2021 it commenced home delivery services in Colorado.

 About Schwazze

Schwazze (OTCQX: SHWZ NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

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

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and outside the state, (vii) our ability to consummate the acquisition described in this press release or to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses, including the acquisition described in this press release, and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, * the timing and extent of governmental stimulus programs, and (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

View original content to download multimedia:https://www.prnewswire.com/news-releases/multi-state-cannabis-operator-schwazze-continues-expansion-in-new-mexico-with-new-rgreenleaf-store-opening-in-hobbs-nm-301896177.html

SOURCE Schwazze

MAIA Biotechnology (MAIA) – 2Q23 Reported With Trial Enrollment Making Progress

Posted on by cpereira@noblefcm.com


Wednesday, August 09, 2023

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.

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.

Second Quarter Reported With Trial Progress. MAIA reported a 2Q23 loss of $(4.5) million or $(0.35) per share, consistent with our expectations. The company gave updates to its Phase 2 THIO-101 clinical trial testing THIO in non-small cell lung cancer (NSCLC), including continued enrollment and survival of patients treated to date. Cash as of June 30, 2023 was $9.1 million.

THIO-101 Trial Update. The THIO-101 trial tests THIO in combination with Libtayo, (cemiplimab, a PD-1 checkpoint inhibitor from Regeneron) giving two mechanisms of action against the cancer cell. Patients in the trial have progressive or relapsing non-small cell lung cancer after being treated with a checkpoint inhibitor. As of July 2023, 35 patients have been enrolled, an increase over the 29 patients last reported in June 2023. We expect top-line Overall Response Rate data in late fall (3Q/4Q) 2023.


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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 – Cocrystal Pharma Selects Novel Oral Protease Inhibitor CDI-988 as Norovirus Lead

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

AUGUST 08, 2023

 DOWNLOAD AS PDF

First dual coronavirus-norovirus oral antiviral is scheduled for Phase 1 in healthy volunteers

In vitro studies show broad-spectrum activity against noroviruses including GII.4 pandemic strains

No approved treatments or vaccines for norovirus infection

BOTHELL, Wash., Aug. 08, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing novel small molecule antiviral therapeutics, announces the selection of its novel, oral, broad-spectrum 3CL protease inhibitor CDI-988 as a potential oral therapy for norovirus. The randomized, double-blind, placebo-controlled Phase 1 study of CDI-988 is approved by Australia Human Research Ethics Committees (HREC). The study is designed to access the safety, tolerability and pharmacokinetics of CDI-988.

With no approved treatments or vaccines, norovirus represents a significant unmet medical need. It is a highly contagious infection and is the most common cause of acute gastroenteritis, accounting for nearly one in five cases. According to the Centers for Disease Control and Prevention (CDC), an estimated 685 million cases and an estimated 200,000 deaths are attributed to norovirus each year worldwide with an estimated societal cost of $60 billion. About 200 million cases are reported among children under five years of age, leading to an estimated 50,000 child deaths every year. Among 30 known genotypes of human norovirus, nearly 60% of outbreaks are attributable to genogroup II, genotype 4 (GII.4) strains, which have caused periodic human pandemics since 1996.

CDI-988 was specifically designed and developed as a broad-spectrum antiviral inhibitor using Cocrystal’s proprietary structure-based drug discovery platform technology. It targets a highly conserved region in the active site of coronaviruses, noroviruses and other 3CL viral proteases. Cocrystal previously selected CDI-988 to investigate as an oral treatment for COVID-19 and is approved to conduct a Phase 1 study in Australia, following approval by that country’s Human Research Ethics Committee (HREC). In recent preclinical in vitro studies, CDI-988 showed potent broad-spectrum antiviral activity against a panel of pandemic GII.4 norovirus proteases and a favorable pharmacokinetic property targeting the gastrointestinal tract.

“In preclinical testing CDI-988 showed significant activity against seven different pandemic strains of norovirus, and we are enthusiastic about developing this compound as a dual broad-spectrum antiviral inhibitor,” said Sam Lee, PhD, Cocrystal President and co-CEO. “CDI-988 further validates our proprietary structure-based drug-discovery platform technology and contributes to our robust product pipeline. Our approach is to develop an effective targeted oral treatment for acute and chronic gastroenteritis caused by norovirus, as well as for potential use in addressing future pandemic norovirus outbreaks.”

“Given the recent increase in norovirus cases and the lack of approved treatments or vaccines, we continue to see a significant opportunity for our broad-spectrum antiviral CDI-988,” said James Martin, Cocrystal CFO and co-CEO. “There has been a sharp rise in norovirus outbreaks worldwide since 1996 with the emergence of the GII.4 strain. Already in 2023, 13 outbreaks on cruise ships have been reported, the largest number of such infections in a decade.”

About Norovirus
Human noroviruses are highly contagious, constantly evolving, extremely stable in the environment and associated with debilitating illness. Symptoms include vomiting and diarrhea, with or without nausea and abdominal cramps. Norovirus infection can be much more severe and prolonged in specific risk groups including infants, children and people with immunodeficiency. In the United States alone, noroviruses are responsible for an estimated 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, according to the CDC. The National Institutes of Health (NIH) estimates the annual burden to the U.S. at $10.6 billion. Outbreaks occur most commonly in semi-closed communities such as nursing homes, hospitals, cruise ships, schools, disaster relief sites and military settings.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2 and noroviruses) and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the initiation and characteristics of a Phase 1 study for CDI-988 and the potential efficacy and clinical benefits of such product candidate. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, regulatory approval to commence the planned trial, risks relating to the Australian economy, manufacturing and research delays arising labor shortages and other factors, the ability of our Clinical Research Organization partner to recruit volunteers for, and to proceed with, the Phase 1 clinical study for CDI-988, and general risks arising from conducting a clinical trial. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

# # #

Source: Cocrystal Pharma, Inc.

Released August 8, 2023

AI Model Can Help Determine Where a Patient’s Cancer Arose

Posted on by phoffman@channelchek.com

Prediction Model Could Enable Targeted Treatments for Difficult Tumors

Anne Trafton | MIT News

For a small percentage of cancer patients, doctors are unable to determine where their cancer originated. This makes it much more difficult to choose a treatment for those patients, because many cancer drugs are typically developed for specific cancer types.

A new approach developed by researchers at MIT and Dana-Farber Cancer Institute may make it easier to identify the sites of origin for those enigmatic cancers. Using machine learning, the researchers created a computational model that can analyze the sequence of about 400 genes and use that information to predict where a given tumor originated in the body.

Using this model, the researchers showed that they could accurately classify at least 40 percent of tumors of unknown origin with high confidence, in a dataset of about 900 patients. This approach enabled a 2.2-fold increase in the number of patients who could have been eligible for a genomically guided, targeted treatment, based on where their cancer originated.

“That was the most important finding in our paper, that this model could be potentially used to aid treatment decisions, guiding doctors toward personalized treatments for patients with cancers of unknown primary origin,” says Intae Moon, an MIT graduate student in electrical engineering and computer science who is the lead author of the new study.

Mysterious Origins

In 3 to 5 percent of cancer patients, particularly in cases where tumors have metastasized throughout the body, oncologists don’t have an easy way to determine where the cancer originated. These tumors are classified as cancers of unknown primary (CUP).

This lack of knowledge often prevents doctors from being able to give patients “precision” drugs, which are typically approved for specific cancer types where they are known to work. These targeted treatments tend to be more effective and have fewer side effects than treatments that are used for a broad spectrum of cancers, which are commonly prescribed to CUP patients.

“A sizeable number of individuals develop these cancers of unknown primary every year, and because most therapies are approved in a site-specific way, where you have to know the primary site to deploy them, they have very limited treatment options,” Gusev says.

Moon, an affiliate of the Computer Science and Artificial Intelligence Laboratory who is co-advised by Gusev, decided to analyze genetic data that is routinely collected at Dana-Farber to see if it could be used to predict cancer type. The data consist of genetic sequences for about 400 genes that are often mutated in cancer. The researchers trained a machine-learning model on data from nearly 30,000 patients who had been diagnosed with one of 22 known cancer types. That set of data included patients from Memorial Sloan Kettering Cancer Center and Vanderbilt-Ingram Cancer Center, as well as Dana-Farber.

The researchers then tested the resulting model on about 7,000 tumors that it hadn’t seen before, but whose site of origin was known. The model, which the researchers named OncoNPC, was able to predict their origins with about 80 percent accuracy. For tumors with high-confidence predictions, which constituted about 65 percent of the total, its accuracy rose to roughly 95 percent.

After those encouraging results, the researchers used the model to analyze a set of about 900 tumors from patients with CUP, which were all from Dana-Farber. They found that for 40 percent of these tumors, the model was able to make high-confidence predictions.

The researchers then compared the model’s predictions with an analysis of the germline, or inherited, mutations in a subset of tumors with available data, which can reveal whether the patients have a genetic predisposition to develop a particular type of cancer. The researchers found that the model’s predictions were much more likely to match the type of cancer most strongly predicted by the germline mutations than any other type of cancer.

Guiding Drug Decisions

To further validate the model’s predictions, the researchers compared data on the CUP patients’ survival time with the typical prognosis for the type of cancer that the model predicted. They found that CUP patients who were predicted to have cancer with a poor prognosis, such as pancreatic cancer, showed correspondingly shorter survival times. Meanwhile, CUP patients who were predicted to have cancers that typically have better prognoses, such as neuroendocrine tumors, had longer survival times.

Another indication that the model’s predictions could be useful came from looking at the types of treatments that CUP patients analyzed in the study had received. About 10 percent of these patients had received a targeted treatment, based on their oncologists’ best guess about where their cancer had originated. Among those patients, those who received a treatment consistent with the type of cancer that the model predicted for them fared better than patients who received a treatment typically given for a different type of cancer than what the model predicted for them.

Using this model, the researchers also identified an additional 15 percent of patients (2.2-fold increase) who could have received an existing targeted treatment, if their cancer type had been known. Instead, those patients ended up receiving more general chemotherapy drugs.

“That potentially makes these findings more clinically actionable because we’re not requiring a new drug to be approved. What we’re saying is that this population can now be eligible for precision treatments that already exist,” Gusev says.

The researchers now hope to expand their model to include other types of data, such as pathology images and radiology images, to provide a more comprehensive prediction using multiple data modalities. This would also provide the model with a comprehensive perspective of tumors, enabling it to predict not just the type of tumor and patient outcome, but potentially even the optimal treatment.

Alexander Gusev, an associate professor of medicine at Harvard Medical School and Dana-Farber Cancer Institute, is the senior author of the paper, which appeared on August 7, 2023, in Nature Medicine.

Reprinted with permission from MIT News ( http://news.mit.edu/ )

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), 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 second quarter of 2023 on Monday, August 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.

Monday, August 14, 2023, 8:00 AM ET 
Domestic: 877-407-3088
International: 201-389-0927
Conference ID: 13739270 
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.

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   

Eric Reiss
Phone: +1 (802) 249-1136
ereiss@tiberend.com

Release – Tonix Pharmaceuticals Completes Clinical Phase of PREVAIL Proof-of-Concept Study of TNX-102 SL for the Treatment of Fibromyalgia-Type Long COVID

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

August 07, 2023 7:00am EDT

Topline Results Expected Third Quarter 2023

Long COVID Afflicts Approximately 19% of Patients Following COVID-191, and is Expected to be a Global Health Burden

Fibromyalgia-Type Long COVID with Multi-Site Pain Affects Approximately 40% of Long COVID Patients

CHATHAM, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced the completion of the clinical phase of the Phase 2 proof-of-concept PREVAIL study of TNX-102 SL as a potential treatment for fibromyalgia-type Long COVID. Topline results for the PREVAIL study are expected in the third quarter of 2023.

“Approximately 40% of U.S. Long COVID patients have fibromyalgia-like multi-site pain symptoms based on our observational studies of Long COVID patients from the TriNetX claims database,”2,3 said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In addition to multi-site pain, these individuals often suffer from one or more other symptoms typically associated with fibromyalgia such as fatigue, sleep disturbance, and brain fog. We have termed this subgroup, ‘Fibromyalgia-type Long COVID.’ Given our encouraging results with TNX-102 SL as a potential treatment for fibromyalgia4, we are testing TNX-102 SL as a bedtime medicine for the management of Fibromyalgia-type Long COVID. In completing this clinical milestone, marked by the last enrolled patient finishing their final visit, we can now begin to look forward to topline results from the 63-patient PREVAIL study later this quarter.”

Dr. Lederman continued, “TNX-102 SL improves sleep quality in fibromyalgia, and we believe this is the mechanism by which TNX-102 SL improves other symptoms, like multi-site pain.5 Recently, the U.S. National Institutes of Health (NIH) has identified improving sleep quality as a target for potential therapeutics for Long COVID6,7,8, consistent with the proposed mechanism of TNX-102 SL.

“Common symptoms of Long COVID, including multi-site pain, fatigue, unrefreshing sleep, and cognitive dysfunction, or ‘brain fog,’ are also hallmarks of conditions like fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME),”9 said Herbert Harris, M.D., Ph.D., Executive Vice President and Head of Translational Medicine of Tonix Pharmaceuticals. “Defining subgroups of Long COVID patients that overlap with fibromyalgia and CFS/ME is expected to facilitate the development of new treatments.4 It can be challenging to distinguish fibromyalgia and CFS/ME clinically, given the high level of symptom overlap between them.  Each of these conditions is defined by a constellation of symptoms, and there is no widely recognized diagnostic laboratory test that distinguishes them.”

Dr. Harris continued, “The recent identification of Long COVID subgroups in the National Institutes of Allergy and Infectious Diseases (NIAID)-sponsored RECOVER study10 was an important step. In their recent publication, cluster analysis of the symptom frequencies in the RECOVER study identified four subgroups of Long COVID patients. Cluster #4 represented approximately one-quarter of the population (28%) and reported the highest frequencies of pain (back pain (58%), joint pain (64%) or muscle pain (60%)), high frequencies of fatigue (94%) and ’Brain Fog,’ (94%) and a high level of impairment of Quality of Life. We believe Cluster #4 is a subgroup of Long COVID that shares many clinical features with fibromyalgia and may involve common disease mechanisms. We also believe that Cluster #3, representing another approximately 29% of the RECOVER cohort, includes many patients with fibromyalgia-type Long COVID because 100% of that group suffer from ‘Brain Fog’, 94% experience fatigue and approximately one-third experience pain (back pain (32%), joint pain (36%) or muscle pain (34%)).”

Dr. Harris concluded, “With no FDA approved treatment for Long COVID, we understand the need to better understand long COVID and to develop treatments for subgroups of this unserved population of patients. Fibromyalgia has been recognized by the U.S. Food and Drug Administration (FDA) with three approved medicines. Consequently, measuring daily pain is a validated endpoint for FDA registrational studies in fibromyalgia. We believe that daily pain has the potential to be an endpoint for registrational studies in fibromyalgia-like long COVID.”

About the Phase 2 PREVAIL Study

The Phase 2 PREVAIL study is a 14-week double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with multi-site pain associated with post-acute sequelae of SARS-CoV-2 infection (PASC). The trial is being conducted at approximately 30 sites in the U.S. The primary efficacy endpoint will be the change from baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. Key secondary efficacy endpoints include change from baseline in self-reported scores for sleep disturbance, fatigue, and cognitive function. Topline results are expected in the third quarter of 2023.

For more information, see ClinicalTrials.gov Identifier: NCT05472090.

About Long COVID or Post-Acute Sequelae of COVID-19 (PASC)

Post-acute sequelae of COVID-19, or PASC is the formal name for a condition now widely known as Long COVID. Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develops a chronic syndrome called Long COVID.11 These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, multi-site pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. According to the Centers for Disease Control and Prevention (CDC), 1 in 13 adults in the U.S. (7.5%) have Long COVID symptoms.1 Long COVID is typically associated with moderate or severe COVID-19, but can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. More than 40% of adults in the United States reported having COVID-19 in the past, and nearly one in five of those (19%) are currently still having symptoms of Long COVID.1 Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.12-15 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 202016 The U.S. Department of Health and Human Services National Research Action Plan on Long COVID17, released in August 2022, addresses the overlap of Long COVID with CFS/ME, which, like fibromyalgia, is one of the overlapping chronic pain syndromes with central and peripheral sensitization.18 A published survey19 found comparable pain, fatigue, and functional impairment between Long COVID, fibromyalgia, and CFS/ME. This symptom overlap between these conditions has suggested that altered neurologic function is one of the leading hypotheses to explain them.20 While the vaccines available in the U.S., through either FDA approval or under Emergency Use Authorization, have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID. Fibromyalgia-type Long COVID, like fibromyalgia and CFS/ME, appears to be one of several chronic overlapping pain conditions that have in common the neurological process called central and peripheral sensitization, which is increasingly known by the term nociplastic pain.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

*TNX-102 SL is an investigational new drug and is not approved for any indication

  1. NIH News Release. June 22, 2022. “Nearly One in Five American Adults Who Have Had COVID-19 Still Have ‘Long COVID’” https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/20220622.htm (accessed August 4, 2023).
  2. Tonix Pharmaceuticals Press Release. Feb 22, 2023. https://ir.tonixpharma.com/news-events/press-releases/detail/1369/tonix-pharmaceuticals-describes-emerging-research-on-the
  3. Harris, H. et al. Tonix data on file 2023
  4. Lederman S, et al. Arthritis Care Res (Hoboken). 2023
  5. Moldofsky H, et al. J Rheumatol. 2011. 38(12):2653-63
  6. NIH News Release. July 31, 2023. “NIH launches long COVID clinical trials through the RECOVER Initiative, opening enrollment.” https://www.nih.gov/news-events/news-releases/nih-launches-long-covid-clinical-trials-through-recover-initiative-opening-enrollment (accessed August 4, 2023).
  7. Howard, J. CNN. July 31, 2023. “Biden administration announces launch of HHS office focused on long Covid research” https://edition.cnn.com/2023/07/31/health/long-covid-research-office/index.html
  8. Johnson, M and Goldstein A. Washington Post. July 31, 2023. “NIH announces long covid treatment studies with hundreds of patients” www.washingtonpost.com/health/2023/07/31/long-covid-treatment-studies-nih/
  9. Clauw DJ, and Calabrese L. Ann Rheum Dis. 2023
  10. Thaweethai T, et al. JAMA. 2023. 329(22):1934-1946
  11. Clauw DJ, et al. Pain. 2020. 161(8):1694-1697
  12. Briggs, A, and Vassall, A. Nature. 2021. 593(7860): 502-505
  13. Nittas V, et al. Public Health Rev. 2022. 43:1604501
  14. Davis, HE., et al. EClinicalMedicine. 2021. 38:101019
  15. Martin C, et al. PLoS One. 2021. 16(12):e0260843
  16. The NIH provision of Title III Health and Human Services, Division M–Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021. The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.
  17. Department of Health and Human Services, Office of the Assistant Secretary for Health. 2022. National Research Action Plan on Long COVID, 200 Independence Ave SW, Washington, DC 20201. www.covid.gov/assets/files/National-Research-Action-Plan-on-Long-COVID-08012022.pdf
  18. Maixner W, et al. J Pain. 2016. 17(9 Suppl):T93-T107
  19. Haider S, et al. Pain. 2023. 164(2):385-401
  20. Sutherland, S. Scientific American. 2023

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 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 the fourth quarter of 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 are expected in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 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 third 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 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. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. 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.

Tonix Medicines has contracted to acquire the Zembrace SymTouch and Tosymra registered trademarks. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc.

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
investor.relations@tonixpharma.com
(862) 904-8182

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

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released August 7, 2023