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Release – Baudax Bio Announces Pricing of $5 Million Public Offering

Posted on December 2, 2022December 2, 2022 by aweinsoff@channelchek.com

December 02, 2022 2:46pm EST

MALVERN, Penn., Dec. 02, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the pricing of a public offering of an aggregate of 1,042,787 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-3 warrants to purchase up to 1,042,787 shares of common stock and Series A-4 warrants to purchase 1,042,787 shares of common stock, at a combined public offering price of $4.795 per share (or pre-funded warrant) and accompanying warrants. The Series A-3 warrants will have an exercise price of $4.50 per share, will be exercisable immediately upon issuance and will expire five years from the date of issuance, and the Series A-4 warrants will have an exercise price of $4.50 per share, will be exercisable immediately upon issuance and will expire thirteen months from the date of issuance. The closing of the offering is expected to occur on or about December 6, 2022, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $5 million. The Company intends to use the net proceeds from this offering for working capital, pipeline development activities and general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-268251), which was declared effective by the Securities and Exchange Commission (the “SEC”) on December 2, 2022. The offering is being made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

The Company also has agreed that certain existing warrants to purchase up to an aggregate of 374,108 shares of common stock of the Company that were previously issued to an investor in November 2020, January 2021, June 2021, December 2021, March 2022, May 2022 and September 2022, at exercise prices ranging from $21.00 to $43.60 per share and expiration dates ranging from October 2023 to September 2027, will be amended effective upon the closing of the offering so that the amended warrants will have a reduced exercise price of $4.50 per share and will expire five years following the closing of the offering.

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

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for hospital and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one in a Phase II study and an additional unique NMB in a dose escalation Phase I study, as well as a proprietary chemical reversal agent specific to these NMBs. Baudax Bio has received approval for and marketed ANJESO^®, the first and only 24-hour, intravenous (IV) COX-2 preferential non-opioid, non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. For more information, please visit www.baudaxbio.com.

Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. Forward-looking statements may include, without limitation, statements regarding the consummation of the offering, the satisfaction of the closing conditions of the offering and the use of net proceeds therefrom. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including Baudax Bio’s ability to realize any anticipated benefits from the reverse stock split, including maintaining its listing on the Nasdaq Capital Market and attracting new investors. These risks and uncertainties include, among other things, risks related to market, economic and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to comply with all listing requirements of the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

Investor Relations Contact:
Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com

Source: Baudax Bio, Inc.

Released December 2, 2022

Release – Genprex to Present at Upcoming December Investor Conference

Posted on December 2, 2022December 2, 2022 by aweinsoff@channelchek.com

Research, News, and Market Data on GNPX

Corporate Presentation to Highlight Company’s Gene Therapies for Cancer and Diabetes

AUSTIN, Texas — (December 2, 2022) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its Executive Vice President, General Counsel and Chief Strategy Officer, Catherine Vaczy, will be providing an overview of the Company’s gene therapies for cancer and diabetes at the following investor conference in December 2022.

Event: RHK 2022 Disruptive Growth Conference

Conference Dates: Dec. 5-6, 2022

Presentation Date: Tuesday, Dec. 6, 2022

Presentation Time: 2:40 p.m. ET

Location: Offices of Reed Smith in New York City

Presenter: Catherine Vaczy, Genprex’s Executive Vice President, General Counsel & Chief Strategy Officer

Ms. Vaczy will be available for Q&A following the presentation and for in-person one-on-one meetings with investors at the RHK Disruptive Growth Conference.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC) (with each of these clinical programs receiving a Fast Track Designation from the Food and Drug Administration) and for small cell lung cancer. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. In models of Type 1 diabetes, the genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. In Type 2 diabetes, where autoimmunity is not at play, it is believed that exhausted beta cells are also rejuvenated and replenished.

For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K for the year ended December 31, 2021.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals, including the extent and impact of the COVID-19 pandemic; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships, including those with its third party manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex’s intellectual property and licenses.

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.

(877) 774-GNPX (4679)

GNPX Investor Relations

investors@genprex.com

GNPX Media Contact

Kalyn Dabbs

media@genprex.com

The Fed Still Has a Long Way to Go To Reel in Wage Inflation

Posted on December 2, 2022December 2, 2022 by phoffman@channelchek.com

Employers Added 263,000 Jobs in November, How this Impacts Future Fed Decisions

There were many more jobs created and filled in the U.S. during November than expected. This may, on the surface, seem like a good thing for the economy, markets, and job seekers. But any expectation that the Fed is past the tipping point and is winning in the battle against conditions that increase prices will have to be curbed for a while.

The number of new hires points to unmet demand in filling positions, and the increase in wages directly adds to the cost of goods sold. Unmet high labor demand is inflationary and part of why the Fed is clear that it is not done.

Fed Chair Powell spoke last Wednesday in a lengthy address outlining the challenges that face the Fed and the avenues it is most likely to take. There is nothing in the strong November jobs report that alters what Powell has said. In fact, it may underscore the resiliency of the economy that the Fed is looking to temper. If you weren’t of the belief that the Fed would push Fed Funds beyond 5%, there is evidence that the Fed may need three 0.50% increases or more before it steps back.

Background

The Fed Chair and other Fed officials have reiterated in recent days that they are likely to lift rates and hold them at levels high enough to slow economic activity and hiring to bring inflation down from 40-year highs.

The just-released employment report for November was expected to come in far below the level reported. Digging even deeper into the numbers, it showed continued rampant hiring and elevated wage growth. The Fed had been hoping to keep a wage-price spiral at bay and get ahead of the supply-demand issues pushing wages and prices up.

The November Unemployment Report

The headline number showed that employers added 263,000 jobs in November while the unemployment rate held steady at 3.7%. But the revised wage data in Friday’s release could concern Fed officials because it points to an acceleration in pay gains in recent months. For the three months that ended in November, average hourly earnings rose at a 5.8% annualized rate. This is a surprising increase from an initially reported 3.9% annualized rate for the three months that ended in October. Economists had expected the U.S. economy had gained 200,000 jobs last month.

At the same time, senior Fed officials have made sure it is no surprise if they lessen the size of rate increases in coming meetings. The next FOMC is the Dec. 13-14 meeting; the Fed is expected to move 0.50% rather than another 0.75%.

Most major stock market indices have traded lower, taking a bearish tone from the report and signs the Fed still is a little behind in its effort to squelch inflation-feeding activity.

Of interest to investors, the sectors with the most job gains were the leisure and hospitality and healthcare industries, both of which had been hard hit during the pandemic, and in government, where employment levels are still 2% below where they stood in February 2020.

Take Away

“To be clear, strong wage growth is a good thing,” Powell said this week. “But for wage growth to be sustainable, it needs to be consistent with 2% inflation.”

The accelerated pace of job growth in November, coupled with upwardly revised October statistics, makes clear to the markets the persistent challenge facing the Federal Reserve. The central bank has repeated that it needs to see some slack in the labor market in order for inflation to fall. This could come from reduced labor demand or increased labor supply, or both.

Release – Cocrystal Pharma Highlights Progress with CC-42344 as a Potential Oral Treatment for Pandemic and Seasonal Influenza A at the World Antiviral Congress 2022

Posted on December 1, 2022December 1, 2022 by aweinsoff@channelchek.com

Research, News, and Market Data on COCP

DECEMBER 01, 2022

Affirms plans to report topline Phase 1 results in 2022 and to initiate Phase 2a influenza human challenge trial in 2023

BOTHELL, Wash., Dec. 01, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that progress with CC-42344 for the treatment of pandemic and seasonal influenza A from its Phase 1 study was presented today at the World Antiviral Congress 2022 underway in San Diego. The presentation, “Novel Broad-Spectrum Influenza A PB2 Inhibitor: Clinical Update,” was delivered by Cocrystal President and co-interim CEO Sam Lee, PhD and the slides are available here.

“We appreciate the opportunity to present our antiviral drug discovery platform technology and favorable interim Phase 1 data,” said Dr. Lee. “Seasonal and pandemic influenza A continue to be major global health threats, especially given the potential for resistance against approved antivirals. Our presentation highlights potential clinical benefits for the treatment of pandemic influenza and the advantages of the oral influenza antiviral CC-42344 drug, which targets the PB2 protein of the influenza polymerase complex. We believe this novel mechanism of action holds promise against all significant influenza A strains including bird flu, while also having a high barrier to resistance. Our assessment to date also indicates that CC-42344 will have a strong synergistic effect when used with approved antivirals.”

In November 2022 Cocrystal reported that orally administered CC-42344 showed a favorable safety profile in both the single- and multiple-ascending dose portions of the Phase 1 study. The Company is currently awaiting pharmacokinetic results from this study and plans to report topline results later this year.

About CC-42344
CC-42344 is a novel PB2 inhibitor discovered using Cocrystal’s proprietary structure-based drug discovery platform technology. CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly conserved regions common to multiple influenza strains. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu^® and Xofluza^®.

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

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential clinical benefits of CC-42344, including its prospective efficacy against all influenza A strains, high barrier to resistance and synergistic effects with approved antivirals, and our plans to report topline results of the Phase 1 study by the end of 2022. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from any future impact of COVID-19 (including long-term or pervasive effects of the virus), inflation, interest rate increases and the war in Ukraine on the U.K. and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our influenza A program, the ability of the contract research organization to recruit patients into clinical trials, the results of future preclinical and clinical studies, and general risks arising from clinical trials. 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, 2021. 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 December 1, 2022

Release – Tonix Pharmaceuticals Presents Development Update on Potential Smallpox and Monkeypox Vaccine TNX-801 in an Oral Presentation at the World Vaccine and Immunotherapy Congress

Posted on December 1, 2022December 1, 2022 by aweinsoff@channelchek.com

Research, News, and Market Data on TNXP

December 01, 2022 7:00am EST

TNX-801 is Based on the Sequence of a Natural Isolate of Horsepox and is Believed Closer in Structure to Edward Jenner’s 1798 Vaccine than Modern Vaccinia Virus Vaccines Against Smallpox

Live-Virus Vaccine Platform Leverages Tonix’s Expanding Internal Development and Manufacturing Capabilities for Biologics

CHATHAM, N.J., Dec. 01, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, presented data from the Company’s TNX-801 (live horsepox virus vaccine) smallpox and monkeypox vaccine development program in an oral presentation at the World Vaccine and Immunotherapy Congress 2022, being held in San Diego, Calif., November 28 – December 1, 2022. A copy of the Company’s presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com

“TNX-801 is a live virus vaccine that we believe is closer to the smallpox vaccines used in the U.S. and Europe before 1900 than the modern vaccinia smallpox vaccines. TNX-801 has reduced virulence in animals, and we believe it has the potential for widespread use to protect against monkeypox,” said Seth Lederman, M.D., President and Chief Executive Officer. “Recent global outbreaks of monkeypox have highlighted the need to be prepared with a vaccine that provides durable immunity and blocks forward transmission. Tonix’s live virus vaccine technology is designed to achieve these outcomes.”

The oral presentation titled, “Live Virus Smallpox and Monkeypox Vaccine,” describes the history of live virus vaccines and rationale for the development of the Company’s Recombinant Pox Virus (RPV) platform, including TNX-801 to protect against monkeypox and smallpox. The presentation describes the origins of immunization, beginning with the first live virus vaccine invented by Dr. Edward Jenner in 1798. The inoculation procedure was called “vaccination” and the inoculum material was initially obtained from lesions on cows affected by a mild disease known as cowpox. However, Dr. Jenner suspected that cowpox originated from horses⁸,which led to immunization using material directly obtained from horses. This procedure was sometimes called “equination”. Equination and vaccination were practiced side-by-side in Europe^13,14. Today, molecular analysis of DNA sequences from archaic smallpox vaccines suggests that TNX-801 is closer than modern smallpox vaccinia vaccines to the vaccine discovered and disseminated by Dr. Edward Jenner^6-8.

As presented at the Canadian Society for Virology in June 2022, non-human primates vaccinated with TNX-801 were fully protected with sterilizing immunity from a challenge with intra-tracheal monkeypox.

In July 2022, the Company announced a collaboration with the Kenya Medical Research Institute (KEMRI) to seek regulatory approval for conducting a Phase 1 clinical study in Kenya to develop TNX-801 as a vaccine to protect against monkeypox and smallpox. The study is expected to start in the first half of 2023.

About TNX-801 and TNX-1850

TNX-801 is a live virus vaccine based on synthesized horsepox^2,3. Tonix is developing TNX-801 for percutaneous administration as a vaccine to protect against monkeypox and smallpox. Tonix has previously reported positive data from a monkeypox challenge study in non-human primates⁴. Tonix is also developing TNX-1850 (horsepox-based live virus vaccines) for the prevention of COVID-19. TNX-1850 is designed to express the spike protein from the BA.2 variants of SARS-CoV-2. Tonix has previously reported positive data from a SARS-CoV-2 challenge study in non-human primates in which animals were vaccinated with TNX-1800, a horsepox-based vaccine expressing spike protein from the Wuhan strain⁵. Tonix’s TNX-801 was synthesized² based on the sequence of the 1976 natural isolate Mongolian horsepox clone MNR-763. Molecular analysis of DNA sequences suggests that TNX-801 is closer than modern smallpox vaccines to the vaccine discovered and disseminated by Dr. Edward Jenner in 1798^6-8. For example, recent studies^9,10 have shown approximately 99.7% colinear identity between TNX-801 and the circa 1860 U.S. smallpox vaccine VK05.¹¹ The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate¹². Relative to vaccinia, horsepox has substantially decreased virulence in mice². Dr. Edward Jenner invented vaccination in 1798 and the procedure was called “vaccination” because ‘cow’ is ‘vacca’ in Latin and the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox. However, Dr. Jenner suspected that cowpox originated from horses⁸. Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination’ from the Latin ‘equus’ which means ‘horse’¹³. Equination and vaccination were practiced side-by-side in Europe^13,14.

About the Recombinant Pox Virus (RPV) Platform

Horsepox virus and vaccines based on its use as a vector are live replicating viruses that elicit strong immune responses. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been exploited as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice². Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials. Tonix’s TNX-801 and RPV vaccine candidates are administered percutaneously using a two-pronged, or “bifurcated” needle. The major cutaneous reaction or “take” to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization’s (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960’s. The “take” is a measure of functional T cell immunity validated by the eradication of smallpox, a respiratory-transmitted disease caused by variola.

About Monkeypox and Smallpox

Monkeypox¹⁵ and smallpox¹⁶ are diseases in humans called by the monkeypox and smallpox (or variola) viruses, respectively. Monkeypox and variola are closely related orthopox viruses. Vaccination against smallpox with live virus vaccines based on horsepox or vaccinia protects against monkeypox. After routine smallpox vaccination was stopped in about 1970, monkeypox has become a growing problem in Africa. Recently approximately 300 cases have been identified outside of Africa.¹⁷ Smallpox is considered eradicated, but there are concerns about malicious reintroduction.

About Tonix Pharmaceuticals Holding Corp.¹

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 a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. 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 first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first 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 and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

¹All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

²Noyce RS, et al. (2018) PLoS One. 13(1):e0188453

³Tulman ER, et al. (2006) J Virol. 80(18):9244-58.PMID:16940536

⁴Noyce, RS, et al. Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox* Presented as a poster at the American Society of Microbiology BioThreats Conference – January 29, 2020, Arlington, VA. (https://content.equisolve.net/tonixpharma/media/10929ac27f4fb5f5204f5cf41d59a121.pdf)

⁵Tonix Press Release March 16, 202a https://ir.tonixpharma.com/news-events/press-releases/detail/1255/tonix-pharmaceuticals-reports-positive-covid-19-vaccine

⁶Schrick L et al. N Engl J Med. (2017) 377:1491.

⁷Qin et al. J. Virol. 89:1809 (2015).

⁸Jenner E. “An Inquiry Into the Causes and Effects of the Variolae Vaccinae: A Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire, and Known by the Name of the Cow Pox.” London: Sampson Low, 1798.

⁹Brinkmann A et al, Genome Biology (2020) 21:286 https://doi.org/10.1186/s13059-020-02202-0

¹⁰Duggan A et al. Genome Biology (2020) 21:175 https://doi.org/10.1186/s13059-020-02079-z

¹¹Tonix press release. Dec 4, 2020 https://ir.tonixpharma.com/news-events/press-releases/detail/1236/vaccine-genome-researchers-report-99-7-colinear-identity

¹²Trindale GS et al. Viruses (2016) (12). Pii: E328. PMID:27973399

¹³Esparza E, et al Vaccine. (2017) 35(52):7222-7230.

¹⁴Esparza J et al. Vaccine. (2020); 38(30):4773-4779.

¹⁵www.cdc.gov/poxvirus/monkeypox/about.html

¹⁶www.cdc.gov/smallpox/research/

¹⁷Mandavilli, A. The New York Times. May 26, 2020. “Who is protected against monkeypox”

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, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, 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

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Released December 1, 2022

Item 9 Labs (INLB) – A Management Change

Posted on December 1, 2022December 1, 2022 by cpereira@noblefcm.com

Thursday, December 01, 2022

Item 9 Labs Corp. (OTCQX: INLB) is a vertically integrated cannabis operator and dispensary franchisor delivering premium products from its large-scale cultivation and production facilities in the United States. The award-winning Item 9 Labs brand specializes in best-in-class products and user experience across several cannabis categories. The company also offers a unique dispensary franchise model through the national Unity Rd. retail brand. Easing barriers to entry, the franchise provides an opportunity for both new and existing dispensary owners to leverage the knowledge, resources, and ongoing support needed to thrive in their state compliantly and successfully. Item 9 Labs brings the best industry practices to markets nationwide through distinctive retail experience, cultivation capabilities, and product innovation. The veteran management team combines a diverse skill set with deep experience in the cannabis sector, franchising, and the capital markets to lead a new generation of public cannabis companies that provide transparency, consistency, and well-being. Headquartered in Arizona, the company is currently expanding its operations space by up to 640,000-plus square feet on its 50-acre site, one of the largest properties in Arizona zoned to grow and cultivate flower. For additional information, visit https://investors.item9labscorp.com/.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

New CEO. Yesterday, Item 9 Labs announced Mike Weinberger, the Company’s Chief Franchise Officer, has assumed the CEO mantle, replacing Andrew Bowden. Given the upcoming transformational acquisition of Sessions Cannabis, we view the change in leadership as a positive for the Company.

Franchise Experience. As Item 9 Labs goes full bore in cannabis franchising, Mr. Weinberger’s long background in the franchising industry will become even more valuable, in our opinion. A 20-plus year franchise industry veteran, Mr. Weinberger launched Item 9 Labs Corp.’s dispensary franchise, Unity Rd., in 2018 and grew the brand to more than 20 entrepreneurial groups driving development across 10 states before the sale of Unity Rd. to Item 9 Labs. Mr. Weinberger also led 500 unit Maui Wowi, a global coffee and smoothie franchise.

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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.

Baudax Bio (BXRX) – Curing the Deficiency: Reverse Stock Split

Posted on December 1, 2022December 1, 2022 by cpereira@noblefcm.com

Thursday, December 01, 2022

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Stock split approved at November 3, 2022 shareholder meeting. Shareholders of record September 29, 2022, approved the 1-for-40 stock split. The stock split will become effective for December 1, 2022, Nasdaq trading. The Company’s common stock will also commence trading under a new CUSIP number (07160F404).

Curing the deficiency. Baudax Bio received Nasdaq notice that the minimum $1.00 bid price requirement was not being met and had until January 2, 2023, to cure the issue, unless they sought to obtain an additional 180 days to regain compliance. The reverse split should bring the Company into listing compliance.

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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).

In the Womb a Genetic Battle Sometimes Rages

Posted on December 1, 2022December 1, 2022 by aweinsoff@channelchek.com

Pregnancy is a Genetic Battlefield – How Conflicts of Interest Pit Mom’s and Dad’s Genes Against Each Other

Baby showers. Babymoons. Baby-arrival parties. There are many opportunities to celebrate the 40-week transition to parenthood. Often, these celebrations implicitly assume that pregnancy is cooperative and mutually beneficial to both the parent and the fetus. But this belief obscures a more interesting truth about pregnancy – the mother and the fetus may not be peacefully coexisting in the same body at all.

At the most fundamental level, there is a conflict between the interests of the parent and fetus. While this may sound like the beginning of a thriller, this genetic conflict is a normal part of pregnancy, leading to typical growth and development both during pregnancy and across an individual’s lifetime – something my research focuses on.

However, even though genetic conflict is normal during pregnancy, it can play a role in pregnancy complications and developmental disorders when left unchecked.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of, Jessica D. Ayers, Assistant Professor of Psychological Science, Boise State University.

What is Genetic Conflict?

Pregnancy is generally thought of as a period when a new individual is created from a unified blend of genes from their parents. But this is not quite right.

The genes a fetus gets from each parent carry slightly different instructions for development. This means there are contrasting and sometimes conflicting blueprints for how to build the new individual. Conflict over which blueprint to follow for fetal growth and development is the essence of the genetic conflict that occurs during pregnancy.

Moms have to use their bodies to help the fetus grow during pregnancy while dads don’t. This means that the genes the fetus inherits from mom have to not only provide for the current fetus, but also try to keep mom alive and healthy and make sure there are resources left over for a potential future pregnancy. These reserves include both biological resources like glucose, protein, iron and calcium, as well as the time and energy needed to help her children after birth as they grow and develop.

Dad’s genes don’t have this same pressure because they don’t use their bodies to help the fetus grow during pregnancy. A dad’s genes, then, don’t need to ensure that anyone other than the current fetus thrives.

To better understand this situation, pretend that all of the resources a mom can give her children come in the form of a milkshake. Once the milkshake runs out, mom has nothing left to give her children. Maternal genes, therefore, want each child to drink only as much as they need to grow and develop. This ensures that the milkshake can be “shared” across all current and future children.

Paternal genes, on the other hand, have no such guarantee of representation in this mother’s other children – the father of the current child may not be the father of the mother’s potential future children. This lack of guaranteed genetic representation means there is no pressure on the father to “share” the milkshake. The best strategy when it comes to paternal genes, then, is for the fetus to drink as much of the milkshake as they can.

These two strategies play a figurative game of tug of war throughout pregnancy. Both sides are trying to pull fetal development slightly more toward their side. Paternal genes encourage the fetus to grow and develop quickly and take more resources, while maternal genes encourage the fetus to grow and use only what’s necessary for proper development. Conflict over how deeply the embryo implants in the uterus and how quickly the placenta and fetus grow are just a few areas where researchers have documented this tug of war during pregnancy.

The milkshake problem helps researchers determine where to look for genetic conflict by simplifying where trade-offs may take place during pregnancy. Because fetal growth is at the heart of genetic conflict, researchers have focused on processes where conflict over resource transfers from mother to fetus can be observed. These investigations have found that the placenta, a fetal organ responsible for all resource transfers during pregnancy, is dominated by paternally-expressed genes. It releases paternally-derived insulin-like growth factors that make mom less sensitive to her own insulin and hormones that increase maternal blood pressure, both of which ultimately increase the amount of resources the fetus can use to grow during pregnancy but have the potential to harm the mother’s health.

Genetic Conflict and Pregnancy Complications

If genetic conflict goes uncontrolled, it can cause pregnancy complications for the mother and developmental disorders for the child. In fact, there is a growing consensus among researchers that some of the most well-known pregnancy complications like preeclampsia, gestational diabetes, miscarriages and preterm births may best be explained by unchecked genetic conflict.

Despite the potential role that genetic conflict plays in pregnancy complications, current medical treatments are reactive rather than proactive. A pregnant person must show signs of experiencing complications before medical interventions and treatments can take place.

Knowing how unchecked genetic conflict contributes to pregnancy complications could provide researchers another way to develop treatments that are proactive and, ideally, preventive. However, there are currently no treatments for pregnancy complications that consider genetic conflict. Though gestational diabetes can be attributed to underlying genetic conflict, a pregnant person must present with elevated blood sugar levels before doctors can treat underlying conflict over insulin production and blood sugar.

Pregnancy During the COVID-19 Pandemic has Been Challenging for Many

The experiences of pregnant people during the COVID-19 pandemic provide an example of why more research on genetic conflict is needed. During the pandemic, doctors saw both a dramatic decrease in the number of preterm births as well as an increase in the number of stillbirths and miscarriages. Both types of complications are influenced by genetic conflict, but the reasons behind these opposing trends are unclear.

As a woman who was pregnant early in the pandemic, my pregnancy was scary and stressful, spent at home away from the pressures of “normal” life. More research on the complex process of pregnancy and genetic conflict’s role in complications could help researchers better understand how the changes brought by the pandemic produced such wildly different pregnancy outcomes.

The Success Rate of Noninvasive Transcranial Magnetic Stimulation for Depression

Posted on December 1, 2022December 1, 2022 by phoffman@channelchek.com

Patients Suffering with Hard-to-Treat Depression May Get Relief from Noninvasive Magnetic Brain Stimulation

Not only is depression a debilitating disease, but it is also widespread. Approximately 20 million adult Americans experience at least one episode of depression per year.

Millions of them take medication to treat their depression. But for many, the medications don’t work: Either they have minimal or no effect, or the side effects are intolerable. These patients have what is called treatment-resistant depression.

One promising treatment for such patients is a type of brain stimulation therapy called transcranial magnetic stimulation.

This treatment is not new; it has been around since 1995. The U.S. Food and Drug Administration cleared transcranial magnetic stimulation in 2008 for adults with “non-psychotic treatment-resistant depression,” which is typically defined as a failure to respond to two or more antidepressant medications. More recently, in 2018, the FDA cleared it for some patients with obsessive-compulsive disorder and smoking cessation.

Insurance generally covers these treatments. Both the psychiatrist and the equipment operator must be certified. While the treatment has been available for years, the equipment to perform the procedure remains expensive enough that few private psychiatry practices can afford it. But with the growing recognition of the potential of transcranial magnetic stimulation, the price will likely eventually come down and access will be greatly expanded.

Does it Work?

Transcranial magnetic stimulation is a noninvasive, pain-free procedure that has minimal to no side effects, and it often works. Research shows that 58% of once treatment-resistant patients experience a significant reduction in depression following four to six rounds of the therapy. More than 40 independent clinical trials – with more than 2,000 patients worldwide – have demonstrated that repetitive transcranial magnetic stimulation is an effective therapy for the treatment of resistant major depression.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Patricia Junquera, Associate Professor and Vice Chair of Clinical Services, Florida International University.

As a professor and psychiatrist who has used transcranial magnetic stimulation to treat some of my patients, I have seen depression symptoms decrease even within the first two weeks of treatment. What’s more, the effects continue after the treatment has ended, typically for six months to a year. After that, the patient has the option of maintenance treatment.

About the Procedure

For the patient, the procedure is easy and simple. One sits in a comfortable chair with a snug pillow that holds their head in place, puts on earplugs and can then relax, check their phone, watch TV or read a book.

A treatment coil, which looks like a figure 8, is placed on the patient’s head. A nearby stimulator sends an electrical current to the coil, which transforms the current into a magnetic field.

The field, which is highly concentrated, turns on and off rapidly while targeting a portion of the prefrontal cortex – the area of the brain responsible for mood regulation.

Researchers know that people suffering from depression have reduced blood flow and less activity in that part of the brain. Transcranial magnetic stimulation causes increases in both blood flow and in the levels of dopamine and glutamate – two neurotransmitters that are responsible for brain functions like concentration, memory and sleep. It’s the repeated stimulation of this area – the “depression circuit” of the brain – that brings the antidepressant effect.

It is Not ‘Electroshock’ or Deep Brain Stimulation

Some people confuse transcranial magnetic stimulation with electroconvulsive therapy, a procedure used for patients with severe depression or catatonia. With electroshock therapy, the anesthetized patient receives a direct electrical current, which causes a seizure. Typically, people who undergo this procedure experience some memory loss after treatment.

Transcranial magnetic stimulation is very different. It doesn’t require anesthesia, and it doesn’t affect memory. The patient can resume daily activities right after each treatment. Dormant brain connections are reignited without causing a seizure.

It should also not be confused with deep brain stimulation, which is a surgical procedure used to treat obsessive-compulsive disorder, tremors, epilepsy and Parkinson’s disease.

Side Effects and Access

Transcranial magnetic stimulation patients undergo a total of 36 treatments, at 19 minutes each, for three to six weeks. Research has concluded that this is the best protocol for treatment. Some patients report that it feels like someone is tapping on their head. Others don’t feel anything.

Some very minor side effects may occur. The most common is facial twitching and scalp discomfort during treatment, sensations that go away after the session ends. Some patients report a mild headache or discomfort at the application site. Depending on how effective the therapy was, some patients return for follow-ups every few weeks or months. It can be used in addition to medications, or with no medication at all.

Not everyone with depression can undergo this type of brain stimulation therapy. Those with epilepsy or a history of head injury may not qualify. People with metallic fillings in their teeth are OK for treatment, but others with implanted, nonremovable metallic devices in or around the head are not. Those with pacemakers, defibrillators and vagus nerve stimulators may also not qualify, because the magnetic force of the treatment coil may dislodge these devices and cause severe pain or injury.

But for those who are able to use the therapy, the results can be remarkable. For me, it is amazing to see these patients smile again – and come out on the other side feeling hopeful.

Release – Tonix Pharmaceuticals Announced Data from its Fully Human anti-SARS-CoV-2 Monoclonal Antibody Platform in an Oral Presentation at the World Antiviral Congress

Posted on November 30, 2022November 30, 2022 by aweinsoff@channelchek.com

Research, News, and Market Data on TNXP

November 30, 2022 7:00am EST

Research Being Conducted in Collaboration with Scientists at Columbia University

SARS-CoV-2 Variants have Evaded Antibody Therapeutics Previously Granted FDA Emergency Use Authorization, but which are No Longer Recommended for Use by the NIH COVID-19 Guidelines Panel

Immunocompromised Individuals, Including Organ Transplant Recipients, are at Increased Risk of Severe COVID-19 and Poor Outcomes

Therapeutic Antibody Platform Leverages Tonix’s Expanding Internal Development and Manufacturing Capabilities for Biologics

CHATHAM, N.J., Nov. 30, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced data from its fully human anti-SARS-CoV-2 monoclonal antibody platform in an oral presentation delivered by Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, at the World Antiviral Congress 2022 in San Diego, Calif. The project is part of a broader research collaboration and option agreement with scientists at Columbia University designed to fill in important gaps in understanding the detailed immune responses to COVID-19, and to provide a foundation upon which to target vaccines and therapeutics to appropriate individuals by precision medicine. A copy of the presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

The presentation titled, “Platform for Generating Fully Human anti-SARS-CoV-2 Spike Therapeutic Monoclonal Antibodies” highlights the need for a broad array of monoclonal antibodies (mAbs) which can be scaled up quickly and potentially combined with other mAbs to treat or prevent COVID-19.

“We believe that the development of these fully human mAbs strengthens our pipeline of next-generation therapeutics to treat Covid-19,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Immunocompromised individuals, including organ transplant recipients, are at increased risk of severe COVID-19 and bad outcomes¹. Although five mAb products, containing 7 distinct mAbs, have received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for either treatment or prophylaxis of COVID-19, only a single product, Evushield^® is still recommended for use as a prophylaxis by the NIH COVID Guidelines panel or FDA^2,3. Moreover, concerns have been raised about the ongoing ability of Evushield to serve as a prophylaxis against COVID-19 in the face of new variants⁴. For these reasons, we believe there is a need for second generation mAb treatments and prophylactics for COVID-19⁵. Generating fully human mAbs starting from recovered patient blood samples has the potential to reduce the time required to create novel therapeutics in response to newly identified COVID-19 variants.”

Ilya Trakht, Ph.D., Associate Research Scientist at Columbia and principal investigator of the sponsored research agreement said, “We are excited to work with Tonix because of their commitment to developing therapeutics to COVID-19. As new variants emerge, anti-spike mAbs that were highly effective against older variants of SARS-CoV-2, may quickly lose their place in the treatment landscape. To protect immunocompromised people, we are committed to assembling a diverse inventory of monoclonal antibodies to keep pace with circulating mix of SARS-CoV-2 variants. Our proprietary technology is based on CD40-ligand promoted B-cell expansion and the MFP-2S human hybridoma system”

Seth Lederman added, “This potential therapeutic antibody platform leverages our expanding internal development and manufacturing capabilities for biologics.”

¹Haidar G, Mellors JW. Improving the Outcomes of Immunocompromised Patients With Coronavirus Disease 2019. Clin Infect Dis. 2021;73(6):e1397-e1401. Doi:10.1093/cid/ciab397

²https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/ – accessed Nov 3, 2022

³“FDA Updates on Bebtelovimab” – “This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.” – www.fda.gov/drugs/drug-safety-and-availability/fda-updates-bebtelovimab– Accessed Nov 4, 2022

⁴Wu, K.J. October 29, 2022. The Atlantic. “The End of Evusheld: If you’re immunocompromised, this … isn’t great. www.theatlantic.com/health/archive/2022/10/covid-variants-antibody-treatments-immunocompromised/671929/

⁵Madison Muller, M. November 16, 2022 Bloomberg. “Doctors Are Running Out of Antibody Drugs to Treat Covid as Virus Mutates.” www.bloomberg.com/news/articles/2022-11-16/covid-s-mutations-leave-doctors-with-far-fewer-antibody-drugs-to-treat-virus?

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 a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. 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 first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first 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 and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

^*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

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Released November 30, 2022

Release – Lineage To Present at BTIG Ophthalmology Day and The Cantor Fitzgerald Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference

Posted on November 29, 2022November 29, 2022 by aweinsoff@channelchek.com

Research, News, and Market Data on LCTX

November 29, 2022 at 8:00 AM EST

PDF Version

Fireside Chat with BTIG Research Scheduled for November 29, 2022 at 12:00pm Eastern
Panel Hosted by Cantor Research Scheduled for December 8, 2022 at 1:45pm Eastern

CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 29, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, will present at the BTIG Virtual Ophthalmology Day, on November 29, 2022 at 12:00pm Eastern Time, in a fireside chat hosted by Yun Zhong, Ph.D., Director, Biotech Equity Research at BTIG. Mr. Culley will also be presenting at Cantor Fitzgerald’s Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference on December 8, 2022 at 1:45pm Eastern as part of the “Ophthalmology Panel, Vision For The Future: Dry AMD, Other Greenfield Opportunities, and Late-Stage Stories To Shake Things Up”. The panel will be hosted by Jennifer Kim, Vice President, Equity Research at Cantor Fitzgerald, and the conference is taking place at the Fontainebleau Miami Beach hotel, December 7-8, 2022.

“I look forward to the opportunity to discuss the evolving landscape in dry AMD, a disease for which there are currently no FDA-approved therapies and which has attracted significant investor attention as of late,” stated Brian M. Culley, Lineage CEO. “Atrophic AMD is a progressive disease that if left untreated can ultimately rob a person of their vision. It is increasingly positive for patients that new potential therapies for dry AMD are attracting mainstream interest, and I am excited at how a cell transplant approach can be more prominently featured in such conversations.”

BTIG’s Virtual Ophthalmology Day 2022 is exploring emerging innovation in ophthalmology and is being hosted by BTIG, a global financial services firm specializing in institutional trading, investment banking, research, and related brokerage services. BTIG’s Corporate Access program hosts client events across the consumer, digital assets, energy and infrastructure, financials, healthcare, real estate and technology sectors. To join the conference, please email info@btig.com.

The Cantor Medical & Aesthetic Dermatology, Ophthalmology & MedTech conference will feature one-on-ones with leading companies in the Medical & Aesthetic Dermatology, Ophthalmology & MedTech industries, as well as key opinion leaders in the dermatology and ophthalmology space. To join the conference and for more information, please contact your Cantor representative.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: investor attention in the dry AMD landscape or mainstream interest in potential dry AMD therapies, and the impacts these may have on patients with, or potential therapies for, dry AMD and the role that cell transplant therapies may have in the treatment of dry AMD moving forward; and the potential benefits of treatment with OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that potential treatments for dry AMD, including OpRegen, may not prove to be successful in clinical trials be and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221128005145/en/

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

LifeSci Advisors
Daniel Ferry
(daniel@lifesciadvisors.com)
(617) 430-7576

Russo Partners – Media Relations
Nic Johnson or David Schull
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

Schwazze (SHWZ) – CEO Dye Adding Shares

Posted on November 29, 2022November 29, 2022 by cpereira@noblefcm.com

Tuesday, November 29, 2022

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

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Insider Buying. In a series of Form 4 filings, between November 14th and November 23rd Schwazze CEO Justin Dye purchased 1,325,852 SHWZ shares at a cost of $2.36 million, or a per share average of $1.78. According to the most recent Form 4 filed on November 25th, Mr. Dye directly currently owns 1,368,062 SHWZ common shares and indirectly owns 9,287,500 SHWZ common shares through Dye Capital & Company.

Details. Through three Form 4 filings, Mr. Dye reported transactions from November 14th through November 23rd. The largest daily purchase of 509,700 shares occurred on November 23rd, which also included the highest average price at $2.00 per share. The recent transactions occurred at prices ranging from $1.13 to $2.10 per share.

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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).

Release – Onconova Therapeutics To Present At The Upcoming RHK Capital Disruptive Growth Conference

Posted on November 28, 2022November 28, 2022 by aweinsoff@channelchek.com

Research, News, and Market Data on ONTX

Nov 28, 2022

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NEWTOWN, Pa., Nov. 28, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that it will participate in the RHK Capital Disruptive Growth Conference being held in the offices of Reed Smith in New York, NY on December 5-6, 2022. Mark Guerin, Chief Operating Officer & Chief Financial Officer, will present a corporate overview at the conference on Tuesday, December 6^th at 11:20 a.m. ET.

To learn more or submit a registration request for the conference, visit http://disruptnyc.com/.

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 two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

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

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