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Release – Gevo, Inc. Announces $150 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

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Gevo, Inc. Announces $150 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

Research, News, and Market Data on Gevo

ENGLEWOOD, Colo., June 06, 2022 (GLOBE NEWSWIRE) — Gevo, Inc. (“Gevo” or the “Company”) (Nasdaq: GEVO), today announced that it has entered into definitive agreements with several institutional investors for the purchase and sale of an aggregate of 33,333,336 shares of common stock, and accompanying warrants to purchase up to an aggregate of 33,333,336 additional shares of common stock, at a public offering price of $4.50 per share and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The warrants have an exercise price of $4.37 per share, are immediately exercisable upon issuance and will expire five years following issuance. The offering is expected to close on or about June 8, 2022, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. Citigroup is acting as capital markets advisor to Gevo.

The gross proceeds from the offering are expected to be $150 million, prior to deducting placement agent’s fees, advisory and other offering expenses payable by Gevo and assuming none of the warrants issued in the offering are exercised for cash. Gevo intends to use the net proceeds from the offering to fund capital projects, working capital and for general corporate purposes.

An automatic shelf registration statement on Form S-3 (File No. 333-252229) relating to the offering of the securities described above was filed with the Securities and Exchange Commission (the “SEC”) on January 19, 2021, and automatically became effective under SEC rules. Such securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, by visiting the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at placements@hcwco.com or by telephone at (212) 856-5711.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 Gevo
Gevo’s mission is to transform renewable energy and carbon into energy-dense liquid hydrocarbons. These liquid hydrocarbons can be used for drop-in transportation fuels such as gasoline, jet fuel, and diesel fuel, that when burned have potential to yield net-zero carbon greenhouse gas emissions when measured across the full lifecycle of the products. Gevo uses low-carbon renewable resource-based carbohydrates as raw materials, and is in an advanced state of developing renewable electricity and renewable natural gas for use in production processes, resulting in low-carbon fuels with substantially reduced carbon intensity (the level of greenhouse gas emissions compared to standard petroleum fossil-based fuels across their lifecycle). Gevo’s products perform as well or better than traditional fossil-based fuels in infrastructure and engines, but with substantially reduced greenhouse gas emissions. In addition to addressing the problems of fuels, Gevo’s technology also enables certain plastics, such as polyester, to be made with more sustainable ingredients. Gevo’s ability to penetrate the growing low-carbon fuels market depends on the price of oil and the value of abating carbon emissions that would otherwise increase greenhouse gas emissions. Gevo believes that its proven, patented, technology enabling the use of a variety of low-carbon sustainable feedstocks to produce price-competitive low carbon products such as gasoline components, jet fuel, and diesel fuel yields the potential to generate project and corporate returns that justify the build-out of a multi-billion-dollar business.

Gevo believes that Argonne National Laboratory GREET model is the best available standard of scientific based measurement for life cycle inventory or LCI.

Learn more at Gevo’s website: 
www.gevo.com

Forward-Looking
Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to a variety of matters, including, without limitation, statements related to the offering of the securities described herein, the closing of the offering and the use of proceeds therefrom. These forward-looking statements are made based on the current beliefs, expectations and assumptions of the management of Gevo and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Gevo undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Gevo believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Gevo in general, see the risk disclosures in the Annual Report on Form 10-K of Gevo for the year ended December 31, 2021 and in subsequent reports on Forms 10-Q and 8-K and other filings made with the U.S. Securities and Exchange Commission by Gevo. 

Investor and Media
Contact
+1 720-647-9605
IR@gevo.com


Release – Ayala Pharmaceuticals Announces Data on AL101 in Adenoid Cystic Carcinoma (ACC) at 2022 ASCO Annual Meeting

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Ayala Pharmaceuticals Announces Data on AL101 in Adenoid Cystic Carcinoma (ACC) at 2022 ASCO Annual Meeting

Research, News, and Market Data on Ayala Pharmaceuticals

— Presentation at ASCO features updated
results from Phase 2 ACCURACY study —

— AL101 demonstrated anti-tumor activity by
achieving an overall disease control rate of 69% —

— Patients achieving partial responses had
higher progression-free survival —

REHOVOT, Israel & WILMINGTON, Del., June 06, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today is announcing data on AL101 from the Phase 2 ACCURACY study in a poster at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3-7, 2022 in Chicago, Illinois.

The poster at ASCO provides updated data from the 4mg and 6 mg AL101 cohorts in the ACCURACY study of the AL101, a selective gamma-secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch activating mutations (Notchmut) (NCT03691207). The most recent safety efficacy, PK, and PD data from the study is presented. The abstract from this study has been released on the 2022 ASCO Annual Meeting website (https://conferences.asco.org).

“We are excited to have AL101 featured in the 2022 ASCO meeting and are pleased with the very promising safety and efficacy data from ACCURACY,” said Gary Gordon, M.D., Ph.D., Chief Medical Officer of Ayala. “ACC is an orphan disease with no approved therapies and patients with Notch mutations have a more aggressive disease course and poorer survival outcomes as compared to patients with Notch wild-type. If approved, we see strong potential for AL101 to provide a much needed treatment option for R/M ACC patients and look forward to further advancing this clinical program.”

ACCURACY is an open-label, single-arm, multicenter Phase 2 study to assess the clinical activity of AL101 using radiographic assessments of patients with R/M ACC demonstrating disease progression within 6 months prior to dosing. It is the first ACC study selecting subjects with ACC bearing defined NOTCH-activating mutations. A total of 87 patients were enrolled (all with RECIST v1.1 evaluable disease or bone exclusive disease deemed evaluable by MD Anderson Bone Response criteria) and of these, 77 were evaluable for efficacy. Approximately 90% of the patients had metastatic disease at screening. This was a heavily pretreated patient population with over half having previously received some form of systemic therapy. Preliminary data from the study were announced by Ayala in 2021.

Efficacy Results

  • In the 4mg dose group, 6 patients (14.6%) had a partial response, 23 (56.1%) had stable disease, for an overall disease control rate of 70.7%
  • In the 6mg dose group, 3 patients (8.3%) had a partial response, 21 (58.3%) had stable disease and for an overall disease control rate of 66.7%
  • Fifty six percent of the 4mg cohort patients and 36% of the 6mg cohort patients experienced some degree of tumor regression.
  • The median progression free survival (PFS) in each of the 4mg and 6mg dose cohorts was 3.7 months but was 6.7 months among the patients who had a partial response
  • Median overall survival (OS) was 9.3 months in the overall group but 12.1 months among the patients who had a partial response.
  • Both dose regimens demonstrated substantial inhibition of the NOTCH pathway consistent with previous studies, but the higher dose did not improve the observed outcomes

Safety

  • AL101 was adequately tolerated with most adverse events being Grade 1 or 2
  • Among all 87 patients, 54 or 62% had treatment related grade 3 or 4 AEs (49% in the 4mg cohort and 76% in the 6mg cohort).

Dr. Renata Ferrarotto, Associate Professor and Director of Head and Neck Oncology Clinical Research at M.D. Anderson Cancer Center and the principal investigator of the study commented “The anti-tumor activity of AL101 in the ACCURACY study suggests that it is providing benefit to a subset of patients with ACC carrying Notch-activating mutations. We are presenting data for the first time showing that subjects who had a partial response to AL101 had progression free survival that was approximately double that of the group as a whole. This result, together with the high disease control rate observed, underscores the clinical relevance of the outcomes, given the aggressive disease course associated with Notch mutations and the fact that the majority of subjects in this trial were heavily pretreated.”

Poster presentation details:

Abstract Title:

 

Results of ACCURACY: A phase 2 trial of AL101, a selective gamma secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch activating mutations (Notchmut)

Abstract
Number:

 

6046

Session Title:

 

Head and Neck Cancer

Session
Date and Time:

 

Monday, June 6, 2022, 1:15 PM-4:15 PM CDT

A copy of the poster will be available on the Ayala corporate website, following the presentation at ASCO on June 6.

About Adenoid Cystic Carcinoma (ACC)

ACC is a rare malignancy of the secretory glands including salivary glands, accounting for about 10% of all salivary gland tumors with an annual incidence of 3,400 in the U.S. There is currently no approved standard of care for patients with recurrent/metastatic ACC. Patients with locoregional disease undergo surgery and radiation therapy, with recurring disease treated by chemotherapy. ACC is an immunologically “cold” tumor that is refractory to chemotherapy, with a recurrence rate of about 60% after initial surgery. The Notch pathway has been determined to be an oncogenic driver of ACC and its dysregulation plays a key role in tumorigenesis and correlates with a distinct pattern of metastasis and a poor prognosis.

About AL101

AL101 is an investigational small molecule Gamma Secretase Inhibitor (GSI) that is designed to potently and selectively inhibit Notch 1, 2, 3 and 4, and is currently being evaluated in the Phase 2 ACCURACY clinical studies in patients with adenoid cystic carcinoma (ACC). AL101 is designed to inhibit the expression of Notch gene targets by blocking the final cleavage step by the gamma secretase required for Notch activation. Ayala obtained an exclusive, worldwide license to develop and commercialize AL101 from Bristol-Myers Squibb Company in November 2017. AL101 was granted U.S. FDA Fast Track Designation and Orphan Drug Designation for the treatment of ACC.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Desmoid Tumors, Adenoid Cystic Carcinoma and T-cell Acute Lymphoblastic Leukemia (T-ALL). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com.

Contacts:

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602

jallaire@lifesciadvisors.com

Ayala Pharmaceuticals:
+1-857-444-0553

info@ayalapharma.com 

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, the timing and results of any clinical trials or readouts, the sufficiency of cash to fund operations, and the anticipated impact of COVID-19, on our business. These forward-looking statements are based on management’s current expectations. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability; we will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of AL101 and AL102; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability; we are heavily dependent on the success of AL101 and AL102, our most advanced product candidates, which are still under clinical development, and if either AL101 or AL102 does not receive regulatory approval or is not successfully commercialized, our business may be harmed; due to our limited resources and access to capital, we must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business; the outbreak of COVID-19, may adversely affect our business, including our clinical trials; our ability to use our net operating loss carry forwards to offset future taxable income may be subject to certain limitations; our product candidates are designed for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop product candidates is novel and may never lead to marketable products; we were not involved in the early development of our lead product candidates; therefore, we are dependent on third parties having accurately generated, collected and interpreted data from certain preclinical studies and clinical trials for our product candidates; enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control; if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed; our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales; the market opportunities for AL101 and AL102, if approved, may be smaller than we anticipate; we may not be successful in developing, or collaborating with others to develop, diagnostic tests to identify patients with Notch-activating mutations; we have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates; even if we obtain FDA approval for our product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential; we have been granted Orphan Drug Designation for AL101 for the treatment of ACC and may seek Orphan Drug Designation for other indications or product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, and may not receive Orphan Drug Designation for other indications or for our other product candidates; although we have received Fast Track designation for AL101, and may seek Fast Track designation for our other product candidates, such designations may not actually lead to a faster development timeline, regulatory review or approval process; we face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively; we are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on one company for the manufacture of the active pharmaceutical ingredient for each of our product candidates; any future collaborations will be, important to our business. If we are unable to maintain our existing collaboration or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected; enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set; if we are unable to obtain, maintain, protect and enforce patent and other intellectual property protection for our technology and products or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our markets; we may engage in acquisitions or in-licensing transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources; and risks related to our operations in Israel could materially adversely impact our business, financial condition and results of operations.

These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the U.S. Securities and Exchange Commission (SEC) on March 28, 2022 and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.


Release – Tonix Pharmaceuticals Announces Presentation at the 2022 BIO International Convention

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Tonix Pharmaceuticals Announces Presentation at the 2022 BIO International Convention

Research, News, and Market Data on Tonix Pharmaceuticals

CHATHAM, N.J., June 06, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2022 BIO International Convention being held June 13-16, 2022 in San Diego, CA. The presentation will take place on Monday, June 13, 2022 at 3:45 p.m. PT in Theater 4 of the San Diego Convention Center.

 

To schedule a meeting with the Company’s management at the convention, please submit a meeting request through the BIO One-on-One Partnering™ system or contact brandon.weiner@westwicke.com.

 

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 first quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA. Finally, 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 second half of 2022. 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 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 second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are 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.

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) 799-8599

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
June 6, 2022


GABY (GABLF) – Reports First Quarter 2022 Results

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Monday, June 06, 2022

GABY (GABLF)
Reports First Quarter 2022 Results

GABY Inc. is a California-focused retail consolidator and the owner of Mankind Dispensary, one of the oldest licensed dispensaries in California. Mankind is a well-known, and highly respected dispensary with deep roots in the California cannabis community operating in San Diego, California. GABY curates and sells a diverse portfolio of products, including its own proprietary brands, Lulu’s™ and Kind Republic™ through Mankind, manufactures Kind Republic, and distributes all its proprietary brands through its wholly owned subsidiary, GABY Manufacturing. A pioneer in the industry with a multi-vertical retail foundation, and a strong management team with experience in retail, consolidation, and cannabis, GABY is poised to­­­ grow its retail operations both organically and through acquisition.

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.

1Q22 Results. GABY reported first quarter revenue of $7.3 million (all figures in CAD$), up from $3.4 million reported last year, driven by the acquisition of Mankind, but down from the $8.2 million in 4Q21. We had estimated revenue of $8.5 million. Variable gross margin for the quarter improved to 47.6% compared to our 47.5% projection. GABY recorded adjusted EBITDA of $0.5 million in the quarter, compared to $0.86 million in 4Q21. Net income for the quarter totaled $1.5 million, or $0.00 per share, driven by one-time items, versus a net loss of $3.9 million, or $0.01 per share, in 4Q21.

Return to Normalcy, Challenging Market Impact Results. The sequential decline in revenue was driven by a return to post-COVID normalcy in cannabis sales and a challenging California market, as we have highlighted previously. Revenues are now back close to pre-COVID levels. …

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

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

Element79 Gold Corp. (ELMGF) – Encouraging Phase I Exploration Results at Dale

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Monday, June 06, 2022

Element79 Gold Corp. (ELMGF)
Encouraging Phase I Exploration Results at Dale

Element79 Gold is a mineral exploration company focused on the acquisition, exploration and development of mining properties for gold and associated metals. Element79 Gold has acquired its flagship Maverick Springs Project located in the famous gold mining district of northeastern Nevada, USA, between the Elko and White Pine Counties, where it has recently completed a 43-101-compliant, pit-constrained mineral resource estimate reflecting an Inferred resource of 3.71 million ounces of gold equivalent* “AuEq” at a grade of 0.92 g/t AuEq (0.34 g/t Au and 43.4 g/t Ag)) with an effective date of Feb. 4, 2022. The acquisition of the Maverick Springs Project also included a portfolio of 15 properties along the Battle Mountain trend in Nevada, which the Company is analyzing for further merit of exploration, along with the potential for sale or spin-out. In British Columbia, Element79 Gold has executed a Letter of Intent to acquire a private company which holds the option to 100% interest of the Snowbird High-Grade Gold Project, which consists of 10 mineral claims located in Central British Columbia, approximately 20km west of Fort St. James. In Peru, Element79 Gold has signed a letter of intent to acquire the business and assets of Calipuy Resources Inc., which holds 100% interest in the past-producing Lucero Mine, one of the highest-grade underground mines to be commercially mined in Peru’s history, as well as the past-producing Machacala Mine. The Company also has an option to acquire 100% interest in the Dale Property which consists of 90 unpatented mining claims located approximately 100 km southwest of Timmins, Ontario, Canada in the Timmins Mining Division, Dale Township.

Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Phase I exploration at Dale. Element79 recently provided an update on the results of its 2021 Phase I exploration program at the Dale property, located within the Swayze Greenstone Belt in Ontario, Canada. The work program, designed to follow up on several prospecting samples that yielded up to 3.8 grams of gold per tonne, consisted of bedrock trenching and soil sampling and was completed in the Fall of 2021. A total of five trenches were excavated, with a total of 83 rock samples and 49 soil samples, which yielded results comparable to earlier prospecting and returned up to 2.6 grams of gold per tonne.

Focus is on Peruvian acquisition and Maverick Springs. While the results of Phase I support a Phase II exploration program, management remains focused on closing the acquisition of the high-grade Peruvian gold portfolio of Calipuy Resources, which we think could occur by mid-July, and advancing the Maverick Springs project in Nevada.   …

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

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

Why the Great Employment Conditions are Causing Market Sell-offs

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Image Credit: Amtec Photos (Flickr)


Great Economic News is Spooking the Stock Market, Here’s Why

Any concern that Fed governors may have harbored that they might overtighten at an inopportune time with an already weakening economy probably ended today. The Labor Department’s employment report released Friday gave them the green light. In fact, the Fed may be even more motivated to stick to its aggressive “back-to-the-future” mindset.

Background

The BLS posted its employment report (June 3), which showed the U.S. economy created 390,000 jobs in May. The unemployment rate held steady at 3.6%. Economists had expected fewer jobs created. This provides evidence for them to work from. It confirms that demand for employees is still outpacing supply and hiring remains competitive.

We’re in a period of stock market history where good economic news is bad news for stocks and bonds and bad news provides relief for markets. In the case of this report, it likely means the Federal Reserve remains on track to raise its key interest rate by 0.50% in June, July, and possibly September.

While job growth has slowed from the 500,000-plus average pace year-over-year, the Consumer Price Index is running at over 8%. There is agreement both from the current Administration in Washington and among market pundits that soaring prices are a huge concern for the nation. President Biden went on record this week in an op-ed posted in the Wall Street Journal and a meeting he had with Fed chair Powell that price increases have caught the attention of the White House.

Good vs. Bad Definitions

Payrolls are still 822,000 below their pre-Covid 19 levels, and the overall jobless rate is only 0.1 percentage point above where it stood in March 2020. At any other time, monthly payroll gains over 200,000 would be considered a strong labor market. In addition, the latest Job Openings and Labor Turnover Survey for April, reported earlier this week, showed 1.9 job vacancies for every unemployed person. This means there are almost two jobs for every job seeker.

The markets sold off on this news. Both the Nasdaq dropped by well over 2%, the S&P by 1.5% and the small-cap Russell 2000, and large Dow Industrials by less than 1%. The reason they are selling off on economic strength is it means rising interest rates becomes more certain. The higher rates will provide better fixed income choices for investors and increase costs for many businesses that will be borrowing at the higher rates.

Other Concerns

At the same time, the Fed has begun the process of winding down its $8.5 trillion dollar balance sheet. The employment data suggests monetary tightening is only just beginning, and businesses face greater headwinds.

The reduction of the balance sheet requires the Fed to allow bonds it owns to mature without the Fed reinvesting alike amount. For June (already accomplished) and July, the Fed is letting $47.5 billion mature without reinvesting. The needs of the U.S. Treasury have changed little so it will have to find new buyers for new bonds near this amount.

Take-Away

Bad economic news is usually bad for equities. Currently, the market is looking for the Fed to have a reason not to raise rates and drain money from the economy. Today’s unemployment number may have emboldened the Fed to act aggressively. The stock and bond markets also are mindful that less money in the economy means fewer investment dollars. The price of anything is a balance of scarcity. As dollars become more scarce asset prices may also retreat.

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://www.bls.gov/news.release/empsit.nr0.htm


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NFT Marketplace Meets Insider Trader

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Image Credit: Andrew (Flickr)


The Case Against an NFT Marketplace Employee that Allegedly was Front-Running

New markets allow new chances for manipulation, rigging, or just good old-fashioned trading on insider information. While the regulatory agencies are still trying to define where they fit in the blockchain asset explosion, some on the inside might already be exploiting what they know may have already defined their role. The Department of Justice has charged a former OpenSea employee in the first-ever NFT insider trading case on Wednesday (June 1).

The allegations concern insider trading in NFTs on the OpenSea platform, the largest online marketplace for the purchase and sale of NFTs. In violation of the employers rules and his duty of trust and confidence to customers and OpenSea, the allegations are that he exploited inside information of what NFTs would be featured on OpenSea’s homepage. The allegations also imply he did this for his own personal benefit.

The employee was in part responsible for selecting NFTs to be featured on OpenSea’s homepage. OpenSea is said to have been properly responsible by keeping confidential the identity of featured NFTs until they were featured on its homepage. After an NFT was posted on OpenSea’s homepage, the market price for that NFT, and for other NFTs created by the same artist, usually increases substantially.

From about June 2021 to at least September 2021, The employee is accused of using OpenSea’s confidential business information about what NFTs were going to be featured on its homepage. He secretly purchase dozens of NFTs shortly before they were featured. After those NFTs were featured on OpenSea, the employee sold them at profits of two- to five times his initial purchase price. Anonymous digital currency wallets were used to conceal the fraud, according to reports.

The person charged is a 31-year-old from New York City. The charges are wire fraud and money laundering, each of which carries a maximum sentence of 20 years in prison. The sentences are prescribed by Congress, however, any sentencing of the defendant will be determined by a judge.

This case is being prosecuted by the Securities and Commodities Fraud Task Force. Assistant U.S. Attorneys Thomas S. Burnett and Nicolas Roos are in charge of the prosecution.

His alleged crimes were uncovered by Twitter “sleuths” that were able to identify the owner of the anonymous accounts. The employer said in a statement that it was aware of insider trading. Opensea has since implemented new policies to prevent future insider trading among its employees.

The charges contained in the Indictment are merely accusations, and the defendant is presumed innocent unless and until proven guilty.

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://www.justice.gov/usao-sdny/pr/former-employee-nft-marketplace-charged-first-ever-digital-asset-insider-trading-scheme

https://markets.businessinsider.com/news/currencies/nft-insider-trading-charge-doj-former-opensea-employee-crypto-2022-6

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Stock Market Signals Gun Law Tightening Unlikely

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Image Credit: K-State Research and Extension


Firearm Stocks Spike After Mass Shootings as Investors Dismiss the Chance of Tightening Gun Laws

The day after an armed 18-year-old entered the Robb Elementary School in Uvalde, Texas, and shot dead 19 children and two teachers, the share prices of gun and weapons manufacturers jumped.

A week on, and the market rally of gun stocks following the latest mass shooting hasn’t subsided. As of the close of trading on May 31, 2022, the stock price of weapons-maker Sturm Ruger was up more than 6.6% since May 23, the day before the shooting. For Smith & Wesson, the jump was even more marked, with shares up over 12% from the stock price prior to the mass killing in Uvalde.


Source: Yahoo Finance

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It was written by and represents the research-based opinions of Brad Greenwood, Associate Professor of Information Systems and Operations Management, George Mason University.

But that relationship – a mass shooting followed by a spike in gun industry stocks – wasn’t always the case. My colleague Anand Gopal and I studied the impact of 93 mass shootings on the stock price of publicly listed firms from 2009 to 2013. We found that, contrary to what happens now, mass shootings in that period were followed by a drop in share price for Smith & Wesson and Sturm Ruger, the two gun companies still publicly listed in the U.S.

So why has that changed? The answer may lie in how hopes of legislation over tighter restrictions on gun sales have dwindled over the last decade. The takeaway is investors no longer seem to worry so much about the chances of tightening firearms regulation when assessing the long-term viability of gun manufacturers in the aftermath of mass shootings.

Let’s look at the factors that influence the valuation of such stocks after mass shootings. First you have increasing demand for weapons. Research has shown that gun sales go up after a high-profile shooting as Americans “arm up,” both out of a perceived concern for their safety and fear of tighter restrictions.

The thinking is simple: “I better buy firearms while I still can, before legislation makes it harder for me to do so.” This increased demand would, on its own, spur the market price of gun and ammunition manufacturers by providing an unanticipated financial windfall.

But then you have the counter factor: Any talk of tighter rules on gun sales puts at risk the long-term viability of the companies by curtailing future cash flows. The business model of gun-makers, after all, is to sell increasing numbers of firearms to the public. Any ban or restrictions on what types of weapon you can purchase – or even who can buy a firearm – would limit their ability to increase profits.

In the period we looked at, investors seemed to lean into this fear of future legislation more, as seen in the reduced valuation of publicly listed firearm companies after mass shootings. Our research showed that the mass shootings from 2009 to 2013 resulted in a penalty imposed on firearms stocks over a two-, five- and 10-day window. That is to say, a mass shooting would be followed by a cumulative abnormal drop in share price over that period. The penalty worked out to around 1.25% over a five-day period.

Interestingly, even over the years we looked at, things began to change. The negative stock market response to mass shootings tapered off in the later years of our study, suggesting that the threat of any regulatory measures was not as keenly felt by investors.

Inaction over gun control at the federal level – and the loosening of regulations among some states – in the years since our work has seemingly led to a rebalancing of the two main factors at play. Yes, there is still the surge of demand for gun sales after mass shootings. But the fear over potential regulations over gun sales has seemingly abated.

 

The surge in the stock price of Smith & Wesson and Sturm Ruger after the Uvalde school shooting provides strong correlational evidence that firearm stocks now rise after such events. A similar effect was seen after the 2018 mass shooting at the Marjory Stoneman Douglas High School in Parkland, Florida.

But there is a problem when it comes to saying outright that there is a link. One of the things in the statistical model we used in our research no longer works. The reason: There are simply too many mass shootings in the U.S. They occur with such frequency that we can no longer implement this kind of analysis looking at the effect of isolated incidents and the stock market effect on gun companies.

In fact, according to the Gun Violence Archive, there were 18 more mass shootings in the U.S. in the seven days after the Uvalde shooting.


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Avivagen Inc. (VIVXF) – A New Vietnamese Distributor

Posted on by Admin

Friday, June 03, 2022

Avivagen Inc. (VIVXF)
A New Vietnamese Distributor

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

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 Distributor. Avivagen’s management recently announced the Company has signed a new distribution agreement with Nong San Viet Co. to support the continued expansion of Avivagen’s OxC-beta feed additive. No details were given on the length of the agreement. We believe that this new distribution, along with the recent China approval and the exclusive distribution agreement with AB Vista, will bring the Company closer to large revenue growth.

Vietnamese Market. Vietnam is home to the largest feed market in Southeast Asia, with total annual feed consumption of over 32 million metric tons in 2020, according to the US Grains Council. The Grain Council reports that Vietnam is a strong growth market for the industry, and is expected to surpass 35 million metric tons within the next few years, with production being dominated by swine, accounting for approximately 38% of total feed, followed by poultry at 21.6%. Swine and poultry are two target markets for Avivagen, so we believe that it bodes well for continued growth for the Company over the next few years….

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

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

Release – Ayala Pharmaceuticals to Present at the 2022 Jefferies Global Healthcare Conference

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Ayala Pharmaceuticals to Present at the 2022 Jefferies Global Healthcare Conference

Research, News, and Market Data on Ayala Pharmaceuticals


REHOVOT, Israel and WILMINGTON, Del., June 02, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today announced that it will participate in a “Fireside Chat” presentation at the Jefferies Healthcare Conference, to take place June 8-10, 2022, in New York, NY. The company will also be available for one-on-one meetings with institutional investors at the conference.

Details on the presentation can be found below:

Date:

Friday, June 10, 2022

Time:

12:15 – 12:40 PM EST

Format:

Fireside Chat

Location:

Marriott Marquis, 1535 Broadway, NYC

A webcast of the presentation will be available on the “Events and Presentations” section of the Ayala Pharmaceuticals website.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma-secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in patients with relapsed/refractory Multiple Myeloma. For more information, visit 
www.ayalapharma.com.

Contacts:

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602

jallaire@lifesciadvisors.com

Ayala Pharmaceuticals:
+1-857-444-0553

info@ayalapharma.com


Release – Kelly to Participate in the Sidoti Virtual Investor Conference

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Kelly to Participate in the Sidoti Virtual Investor Conference

Research, News, and Market Data on Kelly


TROY, Mich., June 2, 2022 /PRNewswire/ — Kelly (Nasdaq: KELYA, KELYB), a leading specialty talent solutions provider, today announced it will participate in the Sidoti Virtual Investor Conference on Thursday, June 16, 2022.

Peter Quigley, president and CEO, Olivier Thirot, executive vice president and chief financial officer, and James Polehna, chief investor relations officer and corporate secretary, will participate in virtual one-on-one meetings. A copy of Kelly’s investor presentation is also available at kellyservices.com.

About
Kelly

Kelly Services, Inc. (Nasdaq: KELYA, KELYB) connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ more than 350,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice. Revenue in 2021 was $4.9 billion. Visit kellyservices.com and let us help with what’s next for you.

KLYA-FIN

ANALYST
& MEDIA CONTACT: 
James Polehna
(248) 244-4586   
james.polehna@kellyservices.com

Cision View original content:
https://www.prnewswire.com/news-releases/kelly-to-participate-in-the-sidoti-virtual-investor-conference-301559691.html

SOURCE Kelly Services, Inc.


Release – Schwazze Closes Acquisition of Assets of Urban Health & Wellness, Inc.

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Schwazze Closes Acquisition of Assets of Urban Health & Wellness, Inc.

Research, News, and Market Data on Schwazze


DENVER, June 1, 2022 /CNW/ – Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), announced today that it closed the transaction to acquire substantially all the assets of Urban Health & Wellness, Inc. (“Urban”).  The transaction includes the adult use Urban Dispensary, located at West 38th Avenue and Clay Street, in Denver’s vibrant Highlands neighborhood as well as a 7,200 square foot indoor cultivation facility (2,700 square feet of canopy) located in Denver, Colorado. This purchase continues Schwazze’s aggressive expansion in Colorado and brings the Company’s total number of Colorado dispensaries to 23 and grow facilities to four. The acquired assets included state and local retail marijuana and marijuana cultivation licenses supporting the adult use dispensary and indoor cultivation facility acquired in the transaction.

 

“Urban’s strategically located dispensary
and grow facility will be excellent additions to our expanding portfolio of
assets in Colorado.  Delivering our brands and our excellent customer
service into new neighborhoods is a Schwazze hallmark as we continue to go deep
in Colorado and New Mexico.” said Nirup Krishnamurthy, Schwazze’s COO.    

The consideration for the acquisition was US$3.2 million, which was paid $1.3M in cash and $1.9M in Company common stock upon closing, of which $288,000 of this common stock consideration was held back by the Company for indemnification claims. The common stock consideration was  split 65% to 35% between the two equityholders of Urban.   At closing, each equityholder that received common stock consideration was required to execute a standard lock-up agreement providing for limitations on resale of the stock consideration received.  There were no finder’s fees or similar arrangements in connection with the transaction.

Since April 2020, Schwazze has acquired or announced the planned acquisition of 33 cannabis dispensaries as well as seven cultivation facilities and two manufacturing assets in Colorado and New Mexico. In May 2021, Schwazze announced its BioSciences division and in August 2021, it commenced home delivery services in Colorado.

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

Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

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

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/schwazze-closes-acquisition-of-assets-of-urban-health–wellness-inc-301558885.html

SOURCE Medicine Man Technologies, Inc.


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

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Tonix Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Requirement

Research, News, and Market Data on Tonix Pharmaceuticals


CHATHAM, N.J., June 02, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. On June 1, 2022, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix’s shares had a closing bid price at or above $1.00 per share for a minimum of 10 consecutive business days, Tonix’s stock had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2), and the matter is now closed.

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 first quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA. Finally, 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 second half of 2022. 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 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 second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are 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.

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) 799-8599

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