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Release – GeoVax to Participate in Upcoming Industry Meetings

Posted on May 25, 2023May 25, 2023 by aweinsoff@channelchek.com

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

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

2023 ASCO Annual Meeting

Date: June 2-6, 2023

Location: McCormick Place, Chicago

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

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

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

2023 BIO International Convention

Date: June 5-8, 2023

Location: Boston Convention and Exhibition Center

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

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

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

About GeoVax

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

Investor Relations Contact:

Rich Cockrell

CG Capital

404-736-3838

govx@cg.capital

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

Posted on May 25, 2023May 25, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

May 25, 2023

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

WESTON, Fla., May 25, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Frontiers in Medicine, demonstrating a role for innate inflammasome activation in two of the most common types of JIA, oligo- and poly-articular, both of which are typically thought to be classical antigen-driven autoimmune conditions.

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

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

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

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

About Inflammasome ASC Inhibitor IC 100

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

About ZyVersa Therapeutics, Inc.

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

Cautionary Statement Regarding Forward-Looking Statements

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

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

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

Corporate and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

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

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

Release – Century Lithium Reconfirms Production Of Battery Grade Purity Lithium Carbonate And Provides Update On Feasibility Study

Posted on May 25, 2023May 25, 2023 by aweinsoff@channelchek.com

Research News and Market Data on CYDVF

May 25, 2023 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (Century Lithium or the Company) is pleased to report it has repeated the production of a high-purity lithium carbonate (Li₂CO₃) grading 99.87% with lithium-bearing claystone from the Company’s 100%-owned Clayton Valley Lithium Project (Project) in Nevada, USA. Several kilograms of the high purity Li₂CO₃were made from the intermediate lithium solutions generated in January at the Company’s Lithium Extraction Facility (Pilot Plant) in Amargosa Valley, Nevada. Following leaching and direct lithium extraction (DLE) at the Pilot Plant, solutions were shipped to Saltworks Technologies Inc. (Saltworks) where the final processing was completed_.

“These results are in line with those we reported in September 2022, when we achieved a significant milestone in making lithium carbonate grading 99.94%” stated Bill Willoughby, President and CEO of Century Lithium. “The latest results confirm our ability to obtain a high purity lithium product with a low level of impurities from our claystone process.”

Century Lithium has now successfully repeated steps from test mining through to the manufacture of battery-grade Li₂CO₃. The table below is a comparison of the latest results with those from September 2022. Also shown, are the constituent levels for battery grade lithium carbonate as published by two major producers. The results for the Company’s lithium carbonate material assays were finalized by Saltworks and SGS Canada Inc.

		Century Li₂CO₃ May 2023	Century Li₂CO₃ September 2022	Reference Source 1	Reference Source 2
Li₂CO₃	wt%	99.875	99.94	>99.5	>99.5
H₂O	wt%	0.03	0.01	<0.2	<0.5
Na	wt%	0.047	0.02	<0.03	<0.05
Ca	wt%	0.009	0.02	<0.01	<0.04
Fe	Wppm	3	15	10	<5
Al	Wppm	<2	6	10	<10
Cu	Wppm	<4	<4	10	<5
Ni	Wppm	<5	<5	10	<6
Cl	wt%	0.008%	0.008%	<0.01%	<0.01%

Scroll right to view more

Notes: wt% (weight percent), wppm (weight parts per million), calculated Li₂CO₃purity based on sum of impurities measured above detection limit
Source 1 & 2: public company’s published composition of battery grade Li₂CO₃,

Feasibility Study Update

A Feasibility Study on the Project (Study) began in February 2022, with the engagement of Wood PLC as independent lead author. The Study has progressed well, with contributions from Global Resource Engineers, WSP USA Environment & Infrastructure Inc., and thyssenkrupp nucera, and with the support of Century Lithium’s personnel and consultants.

Major areas of the Study are completed and estimates for capital and operating cost estimates received, including those for the chlor-alkali plant portion of the Project. Wood is in the process of consolidating the estimates and reviewing them with Century, along with evaluating further optimization and opportunities for cost reductions. This optimization work will extend beyond the previously estimated mid-year completion date for the Study. The Company continues to focus on the Study and will provide updates in due course.

At the Pilot Plant, the collaboration of Century Lithium and Koch Technology Solutions (KTS) is underway testing the KTS Li-Pro™ process for DLE. Century Lithium personnel are working closely with KTS in the testing program, which has now completed its third 7-day cycle of operation. Thus far, the KTS process equipment has operated exceptionally well, using feed solution from the Pilot Plant, and the Company is very pleased with its performance.

Qualified Person

Todd Fayram, MMSA-QP and Daniel Kalmbach, CPG, are the qualified persons as defined by National Instrument 43-101 and have approved the technical information in this release.

About Century Lithium Corp.

Century Lithium Corp. (formerly Cypress Development Corp.) is an advanced stage lithium company, focused on developing its 100%-owned Clayton Valley Lithium Project in west-central Nevada, USA. Century Lithium is currently in the pilot stage of testing on material from its lithium-bearing claystone deposit at its Lithium Extraction Facility in Amargosa Valley, Nevada and progressing towards completing a Feasibility Study and permitting, with the goal of becoming a domestic producer of lithium for the growing electric vehicle and battery storage market.

ON BEHALF OF CENTURY LITHIUM CORP.
WILLIAM WILLOUGHBY, PhD., PE
President & Chief Executive Officer

For further information, please contact:
Spiros Cacos | Vice President, Investor Relations
Direct: +1 604 764 1851
Toll Free: 1 800 567 8181
scacos@centurylithium.com
centurylithium.com

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

Cautionary Note Regarding Forward-Looking Statements

This release includes certain statements that may be deemed to be “forward-looking statements”. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects,” “estimates,” “projects,” “anticipates,” “believes,” “could,” “scheduled,” and other similar words. All statements in this release, other than statements of historical facts, that address events or developments that management of the Company expects, are forward-looking statements. Although management believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results or developments may differ materially from those in the forward-looking statements. The Company undertakes no obligation to update these forward-looking statements if management’s beliefs, estimates or opinions, or other factors, should change. Factors that could cause actual results to differ materially from those in forward-looking statements, include market prices, exploration, and development successes, continued availability of capital and financing, and general economic, market or business conditions. Please see the public filings of the Company at www.sedar.com for further information.

Release – Onconova Therapeutics Announces Dosing Of First Participant In Investigator-Sponsored Phase 2 Trial Of Rigosertib Plus Pembrolizumab In Metastatic Melanoma Patients Refractory To Immune Checkpoint Blockade

Posted on May 25, 2023May 25, 2023 by aweinsoff@channelchek.com

Research News and Market Data ONTX

May 25, 2023

NEWTOWN, Pa., May 25, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the first participant has been dosed in an investigator-sponsored Phase 2 trial of oral rigosertib plus the PD-1 inhibitor pembrolizumab in patients with metastatic melanoma who have progressed on prior PD-1/L1 inhibitor therapy.

“There is an urgent need for new treatment approaches in metastatic melanoma, as 40 to 60% of these patients currently see little to no clinical benefit from PD-1 inhibitors,” said Ann Richmond, Ph.D., Ingram Professor of Pharmacology and Medicine at the Vanderbilt University School of Medicine and Senior Research Career Scientist at TVHS, Department of Veterans Affairs (Nashville). “The limited efficacy of these agents is often due to ‘cold’ tumor microenvironments (TME) that prevent the infiltration of immune effector cells. Peer-reviewed preclinical studies¹ suggest rigosertib can enhance the efficacy of immune checkpoint blockade in metastatic melanoma by reversing cold TMEs, providing a strong scientific rationale for this clinical trial.”

Douglas B. Johnson, M.D., M.S.C.I., Associate Professor of Medicine of Hematology/Oncology at Vanderbilt University Medical Center and Principal Investigator of the trial commented, “Rigosertib combined with anti-PD-1 therapy has shown clinical activity in checkpoint inhibitor refractory lung cancer patients, and we believe this promising finding may translate to melanoma. The newly initiated Phase 2 study has been thoughtfully designed to begin exploring this hypothesis and will afford participants the opportunity to receive a novel therapeutic combination that may lead to improved clinical outcomes. I look forward to conducting the study and to the important scientific insights I expect it will provide.”

The investigator-sponsored Phase 2 trial is an open-label, two-stage, single arm study. Stage 1 of the trial is expected to include ten patients. If a pre-specified response criteria is met, the study will then proceed to Stage 2, during which an additional 19 patients are expected to be enrolled. Patients in the study will receive 560 mg of oral rigosertib twice daily on days 1-21 of 28-day treatment cycles, plus 400 mg of pembrolizumab administered via intravenous infusion every six weeks. The primary endpoint of the trial is overall response rate, while key secondary endpoints include assessments of safety, tolerability, progression-free survival, and overall survival. Correlative biomarker assessments will also be conducted.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, “Rigosertib’s investigator-sponsored trials are an important component of our corporate strategy that allows us to diversify the indications studied with our pipeline while remaining internally focused on our lead narazaciclib program. We are thrilled to be collaborating with Vanderbilt’s world-class physician-scientists on this latest trial and look forward to its advancement.”

For additional information on the Phase 2 trial, see Clincialtrials.gov identifier NCT05764395.

References:

Yan, C., Saleh, N., Yang, J. et al. Novel induction of CD40 expression by tumor cells with RAS/RAF/PI3K pathway inhibition augments response to checkpoint blockade. Mol Cancer 20, 85 (2021). https://doi.org/10.1186/s12943-021-01366-y.

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 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.

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

Forward-Looking Statements

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

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

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

Release – Tonix Pharmaceuticals Announces Poster Presentation at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Posted on May 25, 2023May 25, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 25, 2023 7:00am EDT

CHATHAM, N.J., May 25, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, will present a poster at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 30 – June 2, 2023, at the Loews Miami Beach Hotel in Miami Beach, Florida. The poster will provide an update on the status of the Phase 2 UPLIFT study of TNX-601 ER* (tianeptine hemioxalate extended-release tablets) for the treatment of major depressive disorder (MDD). The poster will also highlight advances in the understanding of tianeptine’s mechanism of action and provide new details regarding the preclinical development of the (S)-isomer of tianeptine, TNX-4300* (estianeptine) for MDD, Alzheimer’s disease, and Parkinson’s disease.

A copy of the Company’s poster will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.

Poster Presentation Details

Title:	A Randomized Placebo-Controlled Multicenter Trial of Monotherapy with TNX-601 ER* (Tianeptine Hemioxalate Extended-Release Tablets) for Treatment of Major Depressive Disorder (MDD)
Location:	Loews Miami Beach Hotel, Miami Beach, Florida
Salon No.:	Salon 4
Date:	Thursday, June 1, 2023
Time:	12:30 p.m. – 2:15 p.m. ET

Tonix Pharmaceuticals Holding Corp.^*

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

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

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

Forward Looking Statements

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

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

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

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

Source: Tonix Pharmaceuticals Holding Corp.

Released May 25, 2023

Release – Helen Cai Joins Largo’s Board of Directors

Posted on May 25, 2023May 25, 2023 by aweinsoff@channelchek.com

Research News and Market Data on LGO

TORONTO–(BUSINESS WIRE)– Largo Inc. (“Largo” or the “Company”) (TSX: LGO) (NASDAQ: LGO) today announces the appointment of Helen Cai as an independent director to its Board of Directors (the “Board”) and the resignation of Ms. Koko Yamamoto.

Helen Cai Joins Largo’s Board of Directors (Photo: Business Wire)

Ms. Cai is a finance and investment professional with two decades of experience in capital markets and all aspects of corporate finance, from strategic planning to merger and acquisition (“M&A”) transactions. Ms. Cai is currently an independent director of Barrick Gold Corporation and most recently worked as a managing director with China International Capital Corporation until the spring of 2021. Prior to this, Ms. Cai worked as a research analyst with the Goldman Sachs Group covering American mining and technology sectors and was highly ranked by the StarMine analyst ranking service. As a lead research analyst at China International Capital Corporation, Ms. Cai was ranked as Best Analyst by Institutional Investor and Asia Money in their China Research Sector Polls for multiple years when covering Hong Kong and Chinese listed companies. The landmark cross-border financing and M&A transactions she led subsequently as a senior investment banker also won various awards from Asia Money and The Asset. Ms. Cai is a Chartered Financial Analyst and Chartered Alternative Investment Analyst and was educated at Tsinghua University in China and the Massachusetts Institute of Technology in the United States, where she received two master’s degrees and multiple fellowship awards.

J. Alberto Arias Chairman of the Board stated, “On behalf of the Board, I am very pleased to welcome Helen to the Company who brings extensive knowledge of the metals and technology sectors, global financial markets, and particularly China, where she is currently based. With her addition, the Board has gained an invaluable member with deep global strategic experience, specifically in China, which is by far the leading producer and consumer of vanadium. China is experiencing the fastest growth in vanadium flow battery deployments, which is expected to become a key catalyst and driver for future vanadium demand growth.” He continued: “We also want to thank Koko for her contribution to Largo’s Board over the last eight years.”

Helen Cai commented: “I am thrilled to be joining Largo’s Board at this incredibly exciting time in the Company’s development. I look forward to collaborating with the Board and management as the Company advances its strategic growth plans to promote the use of vanadium and vanadium-based energy storage.”

Koko Yamamoto stated: “During my tenure as a director, I have enjoyed working with the management team at Largo to promote the use of vanadium and vanadium-based energy storage. As I step away and pursue other opportunities, I remain a supporter of the Company and will continue to be a cheerleader for Largo, its ambitions, and the contribution it is making to advance a low carbon future.”

About Largo

Largo has a long and successful history as one of the world’s preferred vanadium companies through the supply of its VPURE^TM and VPURE+^TM products, which are sourced from one of the world’s highest-grade vanadium deposits at the Company’s Maracás Menchen Mine in Brazil. Aiming to enhance value creation at Largo, the Company is in the process of implementing a titanium dioxide pigment plant using feedstock sourced from its existing operations in addition to advancing its U.S.-based clean energy division with its VCHARGE vanadium batteries. Largo’s VCHARGE vanadium batteries contain a variety of innovations, enabling an efficient, safe and ESG-aligned long duration solution that is fully recyclable at the end of its 25+ year lifespan. Producing some of the world’s highest quality vanadium, Largo’s strategic business plan is based on two pillars: 1.) leading vanadium supplier with an outlined growth plan and 2.) U.S.-based energy storage business to support a low carbon future.

Largo’s common shares trade on the Nasdaq Stock Market and on the Toronto Stock Exchange under the symbol “LGO”. For more information on the Company, please visit www.largoinc.com.

For further information, please contact:

Investor Relations
Alex Guthrie
Senior Manager, External Relations
+1.416.861.9778
aguthrie@largoinc.com

Labrador Gold Corp. (NKOSF) – Drilling To Resume Next Week

Posted on May 25, 2023May 25, 2023 by cpereira@noblefcm.com

Thursday, May 25, 2023

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

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

Hitting on all cylinders. Drilling at Labrador Gold’s 100%-owned Kingsway gold project continues to target the Appleton Fault over a 12-kilometer strike length. The drilling is part of the company’s ongoing 100,000-meter diamond drilling program of which approximately 69,000 meters are complete. Assays are pending for approximately 3,500 meters of core. Most of the drilling has occurred at the Big Vein target which has been drilled over a 722-meter northeast-southwest strike length and remains open in both directions.

Drilling to resume next week. Following the seasonal thaw, drilling is expected to resume next week at the Drop Kick target, previously known as Home Pond South, where 10 to 12 holes representing approximately 2,000 meters of drilling will be completed. Following Drop Kick, the drill could move to the Pristine target where Labrador may drill 5 or 6 holes representing approximately 1,200 meters of drilling. Following Pristine, the drill could move either to the Gap Zone between Pristine and Big Vein or to the Peter Easton target, depending on receipt of drill permits for the Gap Zone. We expect the company to operate with three drill rigs, including two rigs at Big Vein to test for extensions of the mineralization to the northeast and southwest.

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

Young Investor’s Skills are Apparently Well-Suited for Today’s Markets

Posted on May 25, 2023May 25, 2023 by phoffman@channelchek.com

The CFA Institute and FINRA Study on Gen Z Investors Would Put Smiles on Their Parent’s Face

Google’s AI chatbot Bard defines Generation Z, or Gen Z, as “the demographic cohort succeeding Millennials and preceding Generation Alpha.” Broadly, the media use the mid-to-late 1990s as starting birth years and the early 2010s as ending birth years as Gen Z. If one looks at the dates, most had internet in their homes on the day they arrived from the hospital after birth. Technology has advanced since then, and the generation that never knew life without is well-equipped to make it work for them.

Generation Z is considered more proactive about their money than their parents or their parents parents. A survey by the CFA Institute and FINRA Investor Education Foundation determined that 60% or 6 out of 10 of the Gen Z population owned at least some investments. Some 41% said they were investing in individual stocks, and 35% in mutual funds. The most popular investment? Crypto. It was reported that 20% are invested in cryptocurrency and/or non-fungible tokens.

The report clarified that these investors are not yet retirement focused, but instead growing assets to have enough money for traveling or saving for unexpected expenses.

Why Gen Z’s Interest

The FINRA/CFA Institute report gave multiple reasons why young people are getting into investing. These include the ability to learn about investing through social media and other online platforms, the existence of apps that let them invest small amounts, such as through fractional shares, as well as the underlying fear of missing out on a more passive way they could make money.

Top Challenges to Meeting Financial Goals

With many sources easily accessible to this connected generation, Generation Z literally have a world of information in their hand, some of it very good, and some of it is probably worthless or damaging. Social media and internet searches take up the top means of learning about investing for this generation. Still on the subject of learning, they are least likely to talk to a financial professional.

Sources of Information Gen Z Use to Learn About Investing

The FINRA/CFA study drilled down deeper to discover the most popular online sources used by Gen Z for investor information. The highest on the list is YouTube followed by internet searches. Lowest on this list is Facebook.

Portfolio Size and Nature

The median investor from this generation has an account worth $4,000. The women had smaller accounts averaging $3,000 versus Gen Z men, whose accounts averaged $5,000.

Investing began very early for some as 25% of Gen Z investors said they began investing before they turned 18. The report indicated that starting at a relatively young age is common in the U.S., Canada, and the U.K. The technology of today allows investors to start small and trade incrementally, even fractionally. This along with curiosity and comfort with technology, is the driver to the first step.

The report was based on a survey of 2,872 investors and non-investors who were aged 18 to 25, as well as millennial and Generation X investors in the U.S., Canada, U.K., and China.

When first starting out, Gen Z most of these investors (44%) gravitated toward cryptocurrencies, according to the report. The median average they first began investing with is $1,000.

Take Away

The youngest adults are finding themselves motivated to invest, more so than any generation before. The top reason is it is easier for the generation to be involved in the markets. Many trade crypto, and own individual stocks. Video content as well as online searches are the primary sources of investment information.

As an aside, this article prompted me to look at the age demographics provided by Google Analytics for Channelchek. Channelchek provides investor information in both written and video formats. Out of the six age groups that Google tracks, 14% of our site traffic since the beginning of the year is attributable to the Gen Z age group.

Should you have any requests for content, or if you are well-versed in a topic that you think Channelchek readers may benefit from, click my name below to send an email, I’d enjoy speaking with you.

Paul Hoffman

Managing Editor, Channelchek

Sources

CFA/FINRA Report (May 2023)

Bard, from Google AI Provided Minor Cross-reference Information

https://en.wikipedia.org/wiki/Education_of_Generation_Z

Details of the United States Credit Watch and Downgrade Status

Posted on May 25, 2023May 25, 2023 by phoffman@channelchek.com

Fitch Has Placed the United States and Some of its Debt on Credit Watch

What does it mean that rating agency Fitch has put the US debt on credit watch?

According to Fitch Ratings, a rating service that is one of the top three Nationally Recognized Statistical Rating Agencies (NRSRO), has placed the United States AAA Long-Term, Issuer Default Rating (IDR) on rating watch and at risk of a downgrade. The primary reason for the rating agency warning is the apparent standstill of negotiations related to the US borrowing limit along with the approaching day that the US may not be able to refinance the interest portion of approaching US Treasury Bills (T-Bills), US Treasury Notes (T-Notes), and US Treasury Bonds (T-Bonds).

Implications

When a top credit rating agency places a country’s debt on credit watch, it means that the agency is considering lowering that country’s credit rating if conditions remain unchanged or worsen. This would have a number of negative consequences for the country, and could negatively impact those that operate within its economy, this could include:

Higher interest rates on government borrowing
Higher rates on corporate debt priced off of US Treasuries
Higher mortgage rates spread to US Treasuries
A decline in the value of the country’s currency
Increased difficulty in attracting foreign investment

A downgrade of the US government credit rating below AAA would be a major event with far-reaching consequences above and beyond the immediate impacts bullet-pointed above.

Wording of the Fitch Ratings Warning

Rating agencies like Fitch, Moody’s, and S&P are private companies. Debt issuers pay to have their debt issues rated to provide investors with information and a framework of value. These rating agencies or NRSROs are somewhat akin to providers of equity research to stock market participants via company-sponsored research.

Some of the main categories listed by Fitch titled, KEY RATING DRIVERS, are “Debt Ceiling Brinkmanship”, “Debt Limit Reached”, “X-Date Approaching”, “Debt Default Rating Implication”, “Potential Post Default Ratings”, and “High and Rising Public Debt Burden”.

The concern with debt ceiling brinkmanship according to Fitch is the “increased political partisanship that is hindering reaching a resolution to raise or suspend the debt limit despite the fast-approaching x-date (when the U.S. Treasury exhausts its cash position and capacity for extraordinary measures without incurring new debt).”

Fitch’s warning indicates it still expects a resolution to the debt limit before the x-date. However, it believes risks have risen that the debt limit will not be raised or suspended before the x-date and that the government could begin to miss payments on some of its obligations.

Fitch pointed out that the US reached its $31.4 trillion debt ceiling on Jan. 19, 2023. While the US Treasury has taken what Janet Yellen called “extraordinary measures” she also expects the measures could be exhausted as early as June 1, 2023. The cash balance of the Treasury reached USD76.5 billion as of May 23, and sizeable payments are due June 1-2.

The x-date has been defined as the day the US can’t meet its obligations without borrowing above the current Congressional debt limit. Failure to reach a deal “to raise or suspend the debt limit by the x-date would be a negative signal of the broader governance and willingness of the U.S. to honor its obligations in a timely fashion,” Fitch warned. The rating agency indicated this “would be unlikely to be consistent with a ‘AAA’ rating”

Fitch also addressed the 14^th amendment discussions and other unconventional solutions, “avoiding default by non-conventional means such as minting a trillion-dollar coin or invoking the 14th amendment is unlikely to be consistent with a ‘AAA’ rating and could also be subject to legal challenges,” Fitch advised.

The debt default rating warning comes from basic understanding of the role of a rating agency. However, Fitch did offer an opinion on the likelihood. “We believe that failing to make full and timely payments on debt securities is less likely than reaching the x-date, and is a very low probability event.

If a default did occur, Fitch indicated it would be more than one level adjustment to some debt affected. Fitch’s sovereign rating criteria would lead it to downgrade the sovereign rating (IDR) to Restricted Default (RD). Actual affected securities would be downgraded to ‘D’. Additionally, other LT debt securities with payments due within 30 days could be expected to be downgraded to ‘CCC’, and ST T-Bills maturing within the following 30 days could be expected to be downgraded to ‘C’.

“Other debt securities with payments due beyond 30 days would likely be downgraded to the expected post-default rating of the IDR,” Fitch wrote.

The US has a high and rising public debt burden, according to the rating agency. It points out that government debt fell to 112.5% of GDP at year-end 2022 (compared to 36.1% for the ‘AAA’ median). It peaked during the pandemic at 122.3%. Fitch forecasts debt to increase to 117% by end-2024. Debt dynamics under the baseline Congressional Budget Office (CBO) assumptions project that the ratio of federal debt held by the public to GDP will approach 119% within a decade under the current policy setting, a rise of over 20 pp. Fitch also recognizes the added cost of financing, adding, “interest rates have risen significantly over the last year with the 10-year Treasury yield at close to 3.7% (compared to 2.8% a year ago).”

Take Away

The decision to put a country’s debt on credit watch is not made lightly. One company announcement such as this can have an impact felt across the globe. It’s important for them to get this right. NRSROs typically would only put a sovereign nation, especially the US, where its debt is often called “the risk free rate,” and the US dollar serves as fiat currency. Firch did this because they view it as responsible and in line with what securities analysts and the rating services they work for are expected to watch out for.

In the current case of the United States debt ratings, the main concern is the political gridlock in Washington, which has made it difficult to reach an agreement on raising the debt ceiling. If the debt ceiling is not raised, the United States will eventually run out of money to pay its bills, which would trigger a default. Fitch would be embarrassed (and arguably irresponsible) if they maintained a AAA rating just one week before the US Treasury Secretary indicated the nation couldn’t roll its debt.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.fitchratings.com/research/sovereigns/fitch-places-united-states-aaa-on-rating-watch-negative-24-05-2023

Release – GeoVax’s Next-Generation COVID-19 Vaccine Shows High Immunogenicity in Immunocompromised Patients

Posted on May 24, 2023May 24, 2023 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

New and Unpublished Data from Phase 2 Open-Label Safety Study of GEO-CM04S1 Presented at Two Recent Scientific Meetings

Atlanta, GA, May 24, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today the presentation of updates on the development of its next-generation SARS-CoV-2 vaccine, GEO-CM04S1, including preliminary data from an ongoing Phase 2 clinical trial, during the Vaccines Summit Boston 2023 and the Congress for the International Society for the Advancement of Cytometry (CYTO) 2023 meetings.

Each of the presentations included unpublished data from the open-label portion of the Phase 2 trial of CM04S1 (ClinicalTrials.gov Identifier: NCT04977024) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment). The preliminary analysis indicated CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies as well as T cell responses. These data support the planned progression of the Phase 2 clinical study, which includes a direct comparison to currently approved mRNA vaccines.

Kelly McKee, M.D., GeoVax’s Chief Medical Officer, commented, “These data extend to severely immunocompromised patients our earlier findings in healthy adults that GEO-CM04S1 stimulated a robust, durable, and broad-based humoral and cellular immune response against multiple SARS-CoV-2 variants. Validation of these findings in additional patients with hematologic malignancies, who have received CAR-T and stem cell transplants, is underway as we seek to provide a vaccine solution to those individuals unable to mount adequate protective responses with currently available COVID-19 vaccines.”

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

About GEO-CM04S1

CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to provide protection 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.

CM04S1 continues to advance in two Phase 2 clinical studies, one as a primary vaccine for immunocompromised cancer patients, in direct comparison to either the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04977024), and the second as a booster for healthy patients who have previously received either the Pfizer or Moderna vaccine as their initial inoculation (ClinicalTrials.gov Identifier: NCT04639466).

About GeoVax

Forward-Looking Statements

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

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

Investor Relations Contact:

Rich Cockrell

CG Capital

404-736-3838

govx@cg.capital

Release – Ocugen, inc. Announces Pricing Of $16.5 Million Public Offering Of Common Stock

Posted on May 24, 2023May 24, 2023 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 24, 2023

MALVERN, Pa., May 24, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced the pricing of its underwritten public offering of 30,000,000 shares of its common stock for gross proceeds of $16.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Ocugen. The offering is expected to close on or about May 26, 2023, subject to customary closing conditions. In addition, Ocugen has granted to the underwriter a 30-day option to purchase up to 4,500,000 additional shares of its common stock.

Ocugen intends to use the net proceeds from the offering for general corporate purposes, capital expenditures, working capital, and general and administrative expenses.

Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

The underwriter may offer the shares from time to time for sale in one or more transactions on the Nasdaq Capital Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices.

The offering is being made by Ocugen pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (the “SEC”) on February 28, 2023, which became effective on April 21, 2023. A preliminary prospectus supplement related to the offering and the accompanying base prospectus have been filed with the SEC and are available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and accompanying base prospectus relating to this offering may be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th floor, New York, NY 10022; Email: prospectus@cantor.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

About Ocugen, Inc.

Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding Ocugen’s expectations regarding the completion of the offering and the anticipated use of proceeds. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the SEC, including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:

Tiffany Hamilton
Head of Communications
IR@Ocugen.com

Release – Tonix Pharmaceuticals to Present at the June 1st Virtual Investor Summit

Posted on May 24, 2023May 24, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 24, 2023 7:00am EDT

CHATHAM, N.J., May 24, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the June 1^st Virtual Investor Summit on Thursday, June 1, 2023, at 10:30 a.m. ET.

Investors interested in arranging a meeting with the Company’s management during the conference should contact the Investor Summit conference coordinator. A webcast of the presentation can be found here and will be available under the IR Events tab of the Tonix website at www.tonixpharma.com.

Tonix Pharmaceuticals Holding Corp.^*

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

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

Forward Looking Statements

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

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

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

Source: Tonix Pharmaceuticals Holding Corp.

Released May 24, 2023

The FOMC Minutes Define Two Determinants of Future Policy

Posted on May 24, 2023May 24, 2023 by phoffman@channelchek.com

Federal Open Market Committee Minutes Reveal Uncertainty

The Federal Reserve released the minutes of its last Federal Open Market Committee (FOMC) meeting. They show the Fed, as a whole, at the May 2-3 meeting as less than clear as to the near-term direction of monetary policy. The U.S. central bank officials are best described as believing they need to be nimble and react, keeping their options open rather than have a plan to continue raising interest rates or hold them steady after future meetings.

Fed officials remained concerned about inflation. Conversations and debates centered on the impact of tighter financial conditions and the degree of lag with which monetary policy would have an impact. According to the meeting minutes, the expected lag could mean their tightening campaign is nearly finished.

This release provided long-awaited insight and shed a modicum of light on how seriously Fed officials were considering changing course or holding interest rates steady when they met last month.

Actual Decision

Federal Reserve officials moved unanimously to raise interest rates at the central bank’s meeting on monetary policy in May despite significant debate at the time over whether pausing tightening efforts would instead be the more prudent move.

The minutes from the Fed’s May 2-3 meeting show concerns and offer clues as to what is important to various factions of the FOMC.

Key Language in Minutes

Banking

“Participants noted that risks associated with the recent banking stress had led them to raise their already high assessment of uncertainty around their economic outlooks. Participants judged that risks to the outlook for economic activity were weighted to the downside, although a few noted the risks were two-sided.”

In their discussion, various participants commented on developments in banking, noting that the banking system was sound and resilient. They also patted themselves on the back, saying that, “actions taken by the Federal Reserve in coordination with other government agencies had served to calm conditions in that sector, but that stresses remained.”

Some participants noted that the banking sector was well-capitalized overall. The belief is that “the most significant issues in the banking system appeared to be limited to a small number of banks with poor risk-management practices or substantial exposure to specific vulnerabilities.”

U.S. Debt Ceiling

“Some participants also noted concerns that the statutory limit on federal debt might not be raised in a timely manner, threatening significant disruptions to the financial system and tighter financial conditions that weaken the economy.”

Inflation

“Regarding risks to inflation, participants cited the possibility that price pressures could prove more persistent than anticipated because of, for example, stronger-than-expected consumer spending and a tight labor market, especially if the effect of bank stress on economic activity proved modest.”

A few members felt further tightening could bring supply and demand imbalances more in line and reduce inflation pressures.

“Some participants cited the possibility that further tightening of credit conditions could slow household spending and reduce business investment and hiring, all of which would support the ongoing rebalancing of supply and demand in product and labor markets and reduce inflation pressures.”

Lag of Policy on Economy

A number of members saw evidence that policy was on track to rebalance price pressures and having its desired effect.

“In discussing the policy outlook, participants generally agreed that in light of the lagged effects of cumulative tightening in monetary policy and the potential effects on the economy of a further tightening in credit conditions, the extent to which additional increases in the target range may be appropriate after this meeting had become less certain.”

“Participants agreed that it would be important to closely monitor incoming information and assess the implications for monetary policy.”

There are two factors that the FOMC minutes noted would be determinants to whether additional policy actions would be needed, they are:

“…the degree and timing with which cumulative policy tightening restrained economic activity and reduced inflation, with some participants commenting that they saw evidence that the past years’ tightening was beginning to have its intended effect.”

“… the degree to which tighter credit conditions for households and businesses resulting from events in the banking sector would weigh on activity and reduce inflation, which participants agreed was very uncertain.”

“Some participants commented that, based on their expectations that progress in returning inflation to 2 percent could continue to be unacceptably slow, additional policy firming would likely be warranted at future meetings.”

“Several participants noted that if the economy evolved along the lines of their current outlooks, then further policy firming after this meeting may not be necessary.”

“Almost all participants stated that, with inflation still well above the Committee’s longer-run goal and the labor market remaining tight, upside risks to the inflation outlook remained a key factor shaping the policy outlook. A few participants noted that they also saw some downside risks to inflation.”

Uncertainty

Some participants commented at the meeting that they, “saw evidence that the past years’ tightening was beginning to have its intended effect.”

The members seemed to not have a handle on the impact of the health of the banking industry’s impact, the minutes read, “the degree to which tighter credit conditions for households and businesses resulting from events in the banking sector would weigh on activity and reduce inflation, which participants agreed was very uncertain.”

Take Away

The path forward for monetary policy is, as the Federal Reserve has continually stated, data dependent. The clarity of trends of the data is unclear in part because of any expected lag, the health of banking, and the stickiness of inflation.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.federalreserve.gov/monetarypolicy/fomcminutes20230503.htm