Release – Ocugen Announces Dosing Completion Of Subjects With Stargardt Disease In Cohort 2 Of Phase 1/2 GARDian Clinical Trial Of OCU410ST—A Modifier Gene Therapy

Research News and Market Data on OCGN

May 15, 2024

MALVERN, Pa., May 15, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the second cohort of its Phase 1/2 GARDian clinical trial for OCU410ST (AAV-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease as a one-time treatment for life.

“The completion of dosing for Cohort 2 participants signifies an important clinical milestone for our pioneering modifier gene therapy,” said Huma Qamar, MD, MPH, Chief Medical Officer of Ocugen. “We are encouraged by the ongoing positive safety and tolerability profile demonstrated by OCU410ST, enabling us to consider higher doses in patients as we progress with the dose-escalation study. We look forward to sharing preliminary safety and efficacy data from Phase 1 of the clinical trial.”

Six patients with Stargardt disease have been dosed in the Phase 1/2 clinical trial to date. An additional three patients will be dosed with the high dose (Cohort 3) of OCU410ST in the dose-escalation phase.

“There remains a great unmet medical need for patients with Stargardt disease, which is the most common inherited retinal disease affecting the center of the vision and does not have any FDA-approved treatment options. OCU410ST is a novel modifier gene therapy that provides hope to these patients,” said Benjamin Bakall, MD, PhD, Director of Clinical Research at Associated Retina Consultants and Clinical Assistant Professor at University of Arizona, College of Medicine – Phoenix. “I am excited that we completed dosing of the last patient in Cohort 2, who received medium dose of this novel therapeutic leveraging a gene-agnostic approach, at Associated Retina Consultants (ARC) in Phoenix, AZ with the surgical team led by Dr. Mark Kwong, Medical Director of ARC.”

A Data and Safety Monitoring Board meeting will convene next month to review the 4-week safety data of the medium dose cohort before proceeding with Cohort 3 (high dose), which is the final dose in the Phase 1 dose-escalation study.

The GARDian clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410ST in subjects with Stargardt disease and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (3.75×1010 vg/mL), medium dose (7.5×1010 vg/mL), and high dose (2.25×1011 vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which adult and pediatric subjects will be randomized in a 1:1:1 ratio to either one of two OCU410ST dose groups or to an untreated group.

Ocugen is committed to finding solutions for people with inherited retinal disease for whom no effective treatment options exist. While an orphan disease, Stargardt affects approximately 100,000 people in the United States and Europe combined.

The Company expects to provide a clinical trial update for OCU410ST in the third quarter of 2024.

About Stargardt Disease
Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

About OCU410ST
OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathway links to Stargardt disease such as lipofuscin formation, oxidative stress, compliment formation, inflammation, and cell survival networks.

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

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact: 
Tiffany Hamilton 
Head of Communications 
Tiffany.Hamilton@ocugen.com  

Release – SKYX Reports Record First Quarter Sales of $19.0 Million Compared to $18.6 Million for First Quarter 2023 as it Continues to Grow its Market Penetration in the U.S and Canada of its Advanced and Smart Platform Products

Research News and Market Data on SKYX

MIAMI, May 14, 2024 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive platform technology company with over 90 pending and issued patents globally and over 60 lighting and home décor websites, with a mission to make homes and buildings become safe and smart as the new standard, today reported its financial and operational results for the first quarter ended March 31, 2024.

First Quarter 2024 and Recent Subsequent Achievements

Generated record first quarter 2024 sales of $19.0 million in revenue compared to $18.6 million for the first quarter of 2023, including sales of its advanced and smart platform plug and play products.

Reported $19.8 million in cash, cash equivalents, restricted cash, available cash, and investments available for sale as of December 31, 2023, as compared to $22.4 million as of December 31, 2023.

New Global Smart Home and AI Related Patents. SKYX’s new and existing patents enable and enhance performance of smart home and AI sensors in addition to home safety sensors. SKYX recently received 8 additional patent issuances bringing the Company’s intellectual property portfolio to a total of over 90 issued and pending patents, 30 of which are issued patents covering SKYX’s advanced plug and play and smart home platform technologies for the smart home, AI, electrical, and lighting industries in the U.S. and internationally including China, Europe and 2 patents in India.

The Company continues to grow its market penetration of its advanced and smart platform technologies product to both retail and commercial segments, through its e-commerce platform of over 60 websites for lighting and home décor.

Collaboration with a world-leading Chinese Lighting supplier and manufacturer, Ruee Appliances. The collaboration with Ruee will include SKYX’s advanced and smart products to both professional and retail Markets and provide SKYX substantial backing in several areas including financial, mass production manufacturing capabilities, and distribution to global markets including China and Europe. The collaboration is expected to substantially enhance gross margins on SKYX’s product sales.

SKYX and General Electric (GE) signed a 5-year global licensing partnership agreement to license SKYX’s patented advanced and smart home platform technologies, including its ceiling outlet/receptacle-related products as well as its all-in-one smart home platform technology.

Announced a collaboration with world-leading lighting company Kichler, which will include SKYX’s advanced smart and standard products for online, retail, and professional channels.

Announced a collaboration with Quoizel, a premier U.S. lighting manufacturer for nearly 100 years, to integrate SKYX’s advanced smart and standard products for online, retail, and professional channels.

SKYX continues to deliver its products to thousands of homes in the U.S. and Canada and expects its products to be in tens of thousands of homes within a year.

SKYX has started sales to the builder and pro segments and opened over 100 builder and pro accounts during the International Builders’ Show (IBS – NAHB) in Las Vegas.

The Company entered into an agreement to supply approximately 1,000 homes with its advanced smart home platform technologies and is expected to deliver approximately 30,000 units representing a variety of its advanced and smart platform technology products to the developer’s upcoming projects.

SKYX won 7 CES (Consumer Electronics Show) Awards including most recently two awards for its All-In-One Smart Home Platform.

Announced a collaboration with Golden Lighting, a leading provider of elegant lighting solutions in the U.S., which will feature SKYX advanced smart and standard products for online, retail, and professional channels.

Safety Standardization Highlights

The Company filed for a mandatory safety standardization with the National Electrical Code (NEC) for its ceiling outlet receptacle for ceilings in homes and buildings in 2023.

Management believes that after over 12 years of its standardization process, including its product specification approval voting for by ANSI / NEMA (American National Standardization Institute / National Electrical Manufacturing Association), it has met the necessary safety conditions for becoming a ceiling safety standardization requirement for homes and buildings. In the past 12 years, the Company’s product was voted into 10 segments in the NEC Code Book. Voting decisions are at the discretion of the NEC voting members.

The Company’s code team is led by Mark Earley – former head of the National Electrical Code (NEC) and former Chief Electrical Engineer of the National Fire Protection Association (NFPA) – as well as Eric Jacobson, former President and CEO of The American Lighting Association (ALA). Mr. Earley and Mr. Jacobson were instrumental in numerous code and safety changes in both the electrical and lighting industries.

First Quarter 2024 Financial Results

Revenue in the first quarter of 2024 increased to a record $19.0 million, including E-commerce sales as well as smart and standard plug and play products, as compared to $18.6 million in the first quarter of 2023.

Cash, cash equivalents, and restricted cash amounted to $19.8 million as of March 31, 2024, as compared to $22.4 million as of December 31, 2023.

Sales and marketing expenses amounted to $6.5 million during the first quarter of 2024, compared to $5.7 million in the first quarter of 2023.

Net cash loss before interest, taxes, depreciation, and amortization, as adjusted for share-based payments (“adjusted EBITDA”), a non-GAAP measure, amounted to $5.1 million, in addition to a non-cash basis loss of $4.6 million, amounted to a net loss of $9.7 million, or $(0.10) per share, in the first quarter of 2024, as compared to a net cash loss of $4.4 million, in addition to a non-cash basis loss of $3.6 million, amounted to a net loss of $8.0 million, or $0.10 per share, in the first quarter of 2023.

The Company’s financial statements for the quarter ended March 31, 2024, will be filed with the SEC and are available on the Company’s investor relations website. https://ir.skyplug.com/sec-filings/

Management Commentary

The first quarter of 2024, which reflected expected tempered revenues following traditionally stronger calendar fourth-quarter sales, was highlighted by our continued market penetration and positioning that not only includes the Ruee Appliances collaboration but also developing our sales channels and focusing on sales and marketing programs with key stakeholders in such channels. We believe we have accelerated our cadence of sales with a robust gross margin profile, notably managing our cash burn. Additionally, our e-commerce platform with over 60 websites is providing additional cash flow to the Company, which, when combined with our existing cash, enhances our cash position to continue executing our business plan. We believe we will be cash flow positive during 2025.

We are encouraged by our path to the builder/commercial segments, large online and brick-and-mortar retail partners as well as our future potential to realize incremental licensing, subscription, and AI/data aggregation revenues.

Furthermore, our e-commerce website platform with 60 websites enhances the acceleration of marketing, distribution channels, collaborations, and sales to both professional and retail segments. Our websites include banners, videos, and educational materials regarding the simplicity, cost savings, timesaving, and lifesaving aspects of the Company’s patented technologies.

About SKYX Platforms Corp.

As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 90 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.

Forward-Looking Statements

Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.

Non-GAAP Financial Measures

Management considers earnings (loss) before interest, taxes, depreciation and amortization, or EBITDA, as adjusted, an important indicator in evaluating the Company’s business on a consistent basis across various periods. Due to the significance of non-recurring items, EBITDA, as adjusted, enables management to monitor and evaluate the business on a consistent basis. The Company uses EBITDA, as adjusted, as a primary measure, among others, to analyze and evaluate financial and strategic planning decisions regarding future operating investments and potential acquisitions. The Company believes that EBITDA, as adjusted, eliminates items that are not part of the Company’s core operations, such as interest expense and amortization expense associated with intangible assets, or items that do not involve a cash outlay, such as share-based payments and non-recurring items, such as transaction costs. EBITDA, as adjusted, should be considered in addition to, rather than as a substitute for, pre-tax income (loss), net income (loss) and cash flows used in operating activities. This non-GAAP financial measure excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements and is subject to inherent limitations. Investors should review the reconciliation of this non-GAAP financial measure to the comparable GAAP financial measure. Investors should not rely on any single financial measure to evaluate the Company’s business.

Investor Relations Contact:

Jeff Ramson

PCG Advisory

jramson@pcgadvisory.com

SKYX Platforms (SKYX) – Q1 in Line, Reaffirming Outlook


Wednesday, May 15, 2024

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

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

Solid Q1 results. The company reported Q1 revenue of $19.0 million and an adj. EBITDA loss of $4.5 million, both of which were in-line with our estimates of $20.0 million and a loss of $4.5 million, respectively. Notably, the company is poised to benefit from several strategic partnerships with large industry players and has entered into an agreement with a homebuilder that is building 1,000 homes. 

Favorable strategic partnerships. We believe the company’s strategic partnerships with industry leaders should contribute to strong revenue growth and market penetration. Notable partnerships include a five-year licensing partnership with General Electric (GE), as well as partnerships with industry leading lighting companies, Kichler, Quoizel, and Golden lighting.


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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. 

Ocugen (OCGN) – 1Q24 Reported With Upcoming Clinical Milestones As Expected


Wednesday, May 15, 2024

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

1Q24 Reported With Clinical Trial Updates. Ocugen reported 1Q24 loss of $11.9 million or $(0.05) per share, and gave updates on progress of its clinical trial during the quarter. Its three main ophthalmic disease programs continued their progress and completed stages of development. Data announcements and milestones are expected for the rest of FY2024. Cash on March 31, 2024 was $26.4 million.

OCU400 Phase 3 Trial Expected Shortly. The Phase 3 trial for OCU400, known as the liMeliGhT incorporating “Master Gene Therapy” into its name, has received FDA clearance and is expected to begin treating retinitis pigmentosa (RP) patients in 2Q24. The trial has a planned enrollment of 150 patients, divided into an arm with 75 RHO mutation patients and 75 patients with any RP associated mutation (gene agnostic). The primary endpoint is luminance dependent navigation assessment (LDNA. As results from the Phase 1/2 study in Leber congenital amaurosis (LCA) become available, the trial could be expanded enroll LCA patients later in 2024.


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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. 

Lifeway Foods (LWAY) – Another Record Quarter


Wednesday, May 15, 2024

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , 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.

Continued Growth. The first quarter marked another quarter of net sales growth for Lifeway, the 18th consecutive quarter to do so. The quarter was also the 4th in a row of recording record net sales. The record quarter is coupled with an improved gross margin from the prior year, flowing through to an improved net income. We believe the continued growth is a testament to management’s strategy in marketing its products and investments made towards production efficiency.

Another Record. Net sales were $44.6 million, a new record for Lifeway, from $38.9 million in the previous year and above our estimate of $43 million. Gross margin was 25.8% from 21.7% last year. Net income totaled $2.4 million, or $0.16 per diluted share, compared to $0.8 million, or $0.06, in the prior year. We estimated net income of $3.6 million, or $0.24 per diluted share.


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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. 

GeoVax Labs (GOVX) – 1Q24 Reported With Clinical Milestones Later In FY2024


Wednesday, May 15, 2024

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

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Clinical Trial Treatment Continues With Milestones Ahead. GeoVax reported a 1Q24 loss of $5.6 million or $(2.47) per share. The company gave updates for its three trials testing GM04S1 and its Phase 1/2 trial testing Gedeptin, including the expected announcement about future clinical development for Gedeptin. Cash on March 31, 2024 was $0.8 million.

Gedeptin Is Finishing Its Phase 1/2 Study. The Phase 1/2 trial testing Gedeptin in advanced head and neck cancer has completed enrollment, with the next steps of development in planning stages. The current plan is to continue development in head and neck cancer, with an announcement coming regarding future trials. This could include testing in combination with an immune checkpoint inhibitor (ICI). Trial data and development announcements are expected in 3Q24.


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

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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. 

FAT Brands (FAT) – First Step To A Twin Peaks IPO


Wednesday, May 15, 2024

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , 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.

Filing. FAT Brands announced the operating unit for Twin Peaks (TP) and Smokey Bones (SB) confidentially submitted a registration statement to the SEC to become a standalone public reporting company. While timing and completion of an IPO of the units is subject to numerous conditions, this is a first step.

Confidential? The SEC permits issuers to submit draft registration statements relating to IPOs for review by the SEC staff on a confidential basis. The confidential submission process is intended to give issuers more flexibility to plan their offerings and reduce the potential for lengthy exposure to market fluctuations that can adversely affect an offering. It is our understanding that a confidential filing allows the issuer to defer the public disclosure of sensitive commercial and financial information.


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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. 

Century Lithium Corp. (CYDVF) – On the Path Leading to a Production Decision


Wednesday, May 15, 2024

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

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

Results of the Clayton Valley feasibility study. Century released the results of a feasibility study (FS) for its Clayton Valley lithium project in Nevada. A phased approach was adopted. Phase I and II mining rates of 7,500 tonnes per day and 15,000 tonnes per day, respectively, are maintained over five years each, while the Phase III mining rate of 22,500 tonnes per day is maintained for 30 years. The production plan reflects a life-of-mine average of 34,000 tonnes per year of battery grade lithium carbonate or 13,000 tonnes and 27,000 tonnes per year during Phase I and II, respectively, and 41,000 tonnes per year during Phase III.

Updating our financial model. We have assumed the mine begins commercial production in 2029. Our mining model is for the years 2029 through 2069. While our financial assumptions are detailed in the body of this report, our valuation is based on the present value of free cash flows, and we have used a discount rate of 8.0%. Our price target for the equity is C$3.25 per share or US$2.35 per share. In our view, the project’s low operating cost after sales of surplus sodium hydroxide is a key differentiator relative to other lithium projects.


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

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

Bitcoin Depot (BTM) – Planting the Seeds For Attractive Revenue Growth


Wednesday, May 15, 2024

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

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

A transitional quarter. The company reported Q1 revenue of $138.5 million, down 15% year over year, but beating our estimate of $134.7 million. Adj. EBITDA in the quarter was $4.9 million, higher than our estimate of $4.0 million. The results reflected redeployment of kiosks and lowered results in California due to unfavorable legislation. 

Favorable kiosk growth. We believe that the company is setting the stage for accelerated revenue and cash flow growth through the deployment of kiosks. In Q1, the company increased the number of deployed kiosks by roughly 700. Post Q1, the company announced the purchase of approximately 2,300 Bitcoin kiosks at a sizeable discount of roughly 50% per-kiosk. The purchase brings the number of kiosks owned by the company to over 10,000, of which 7,061 were deployed, as of the end of Q1. 


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

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

Jamie Dimon’s Candid Warning on U.S. Fiscal Deficit

In a recent interview, Jamie Dimon, the CEO of JPMorgan Chase, issued a stark warning to the United States regarding its fiscal deficit. Dimon’s stern warning has significant ramifications, not only for policymakers but also for investors closely monitoring economic trends and government policies that can influence market dynamics and investment strategies.

Dimon’s primary concern revolves around the rapid escalation of the fiscal deficit, which currently stands at a staggering 6% of the nation’s GDP. This surge is largely attributable to the extensive measures implemented during and after the COVID-19 pandemic, including interest rate hikes, tax cuts, and massive stimulus programs. While these actions were intended to buoy the economy during turbulent times, Dimon cautions that their long-term consequences, if not counterbalanced by fiscal discipline, could be detrimental.

A prominent issue highlighted by Dimon is the potential impact on inflation. Unchecked deficit spending can fuel higher inflation rates, eroding the purchasing power of investors and consumers alike. Inflation trends are closely watched by investors, as they can influence interest rates, asset prices, and overall investment strategies. Moreover, a ballooning deficit can signal underlying economic imbalances, potentially necessitating corrective measures in the future that could disrupt investment portfolios.

Moreover, Dimon’s remarks shed light on the broader economic outlook. A ballooning deficit can signal underlying economic imbalances and may necessitate corrective measures in the future. For investors, this underscores the importance of staying informed about macroeconomic indicators and government fiscal policies that can shape investment opportunities and risks.

Dimon’s call for addressing the deficit resonates with the broader theme of fiscal responsibility in investment strategies. Investors often seek opportunities in sectors or assets less vulnerable to fiscal uncertainties or inflationary pressures. Diversification across asset classes and regions can also mitigate risks associated with policy changes. Furthermore, Dimon’s commentary underscores the interplay between government policies and market dynamics, as policy decisions, such as deficit reduction efforts, can shape market sentiment, investor confidence, and long-term economic stability.

Furthermore, Dimon’s commentary touches on the relationship between government policies and market dynamics. Investors are mindful of how policy decisions, such as deficit reduction efforts, can influence market sentiment, investor confidence, and long-term economic stability. Understanding these interconnections is crucial for making informed investment decisions.

Beyond fiscal matters, Dimon’s advocacy for respectful dialogue and understanding across political divides is noteworthy. Political stability and consensus on economic policies can contribute to a favorable investment climate. Investors value predictability and clarity in policy frameworks, as they provide a foundation for long-term planning and investment allocation.

In conclusion, Jamie Dimon’s warning regarding the U.S. fiscal deficit carries significant implications for investors. It underscores the importance of fiscal responsibility, the potential impact on inflation and market dynamics, and the value of informed decision-making in navigating economic uncertainties. As investors evaluate opportunities and risks, staying attuned to developments in fiscal policy and economic trends will remain paramount in shaping investment strategies.

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Inflation Just Dropped a Massive Hint About the Fed’s Next Move

The major U.S. stock indexes inched up on Tuesday as investors digested mixed producer inflation data and turned their focus to the much-anticipated consumer price index report due out on Wednesday.

The producer price index (PPI) for April showed prices paid by businesses for inputs and supplies increased 0.2% from the prior month, slightly above economists’ expectations of 0.1%. On an annual basis, PPI rose 2.3%, decelerating from March’s 2.7% pace but still higher than forecasts.

The “hot” PPI print caused traders to dial back bets on an interest rate cut from the Federal Reserve at its September meeting. Fed funds futures showed only a 48% implied probability of a 25 basis point rate cut in September, down from around 60% before the report.

Speaking at a banking event in Amsterdam, Fed Chair Jerome Powell characterized the PPI report as more “mixed” than concerning since revisions showed prior months’ data was not as hot as initially reported. He reiterated that he does not expect the Fed’s next move to be a rate hike, based on the incoming economic data.

“My confidence [that inflation will fall] is not as high as it was…but it is more likely we hold the policy rate where it is [than raise rates further],” Powell stated.

Investors are now eagerly awaiting Wednesday’s consumer price index data as it will provide critical signals on whether upside inflation surprises in Q1 were just temporary blips or indicative of a more worrying trend.

Consensus estimates project headline CPI cooled to 5.5% year-over-year in April, down from 5.6% in March. Core CPI, which strips out volatile food and energy prices, is expected to moderate slightly to 5.5% from 5.6%.

If CPI comes in hotter than projected, it would solidify expectations that the Fed will likely forego rate cuts for several more months as it prioritizes restoring price stability over promoting further economic growth.

Conversely, cooler-than-forecast inflation could reinforce the narrative of slowing price pressures and clear the path for the Fed to start cutting rates as soon as June or July to provide a buffer against a potential economic downturn.

The benchmark S&P 500 index closed up 0.18% on Tuesday, while the tech-heavy Nasdaq gained 0.43%. Trading was choppy as investors bided their time ahead of the CPI release.

Market focus has intensified around each new inflation report in recent months as investors attempt to gauge when the Fed might pivot from its aggressive rate hike campaign of the past year.

With inflation still running well above the Fed’s 2% target and the labor market remaining resilient, most economists expect the central bank will need to keep rates elevated for some time to restore price stability. But the timing and magnitude of any forthcoming rate cuts is still hotly debated on Wall Street.

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The Shocking New Tech that Reads Your Mind!

As the world’s largest technology companies continually search for new avenues of innovation and growth, an unlikely field is rapidly emerging as the next major opportunity – neuroscience and the ability to interface directly with the human brain.

While the idea of mind-reading may sound like science fiction, recent breakthroughs powered by artificial intelligence have brought brain-computer interfaces into reality. And the tech giants are taking notice, pouring hundreds of millions into developing these neurotechnologies with an eye on future ecosystems and revenue streams.

A $55 Billion Neurotechnology Gold Rush
According to market research firm Precedence, the global neurotechnology market was valued at around $15 billion in 2023. However, it’s projected to skyrocket to over $55 billion by 2032 as medical applications come to market and consumer use cases emerge.

This rapidly expanding opportunity has kicked off a modern-day gold rush as deep-pocketed companies like Meta, Apple, Amazon, Microsoft, and even Elon Musk’s Neuralink race to stake their claims.

In the medical field, brain-computer interface (BCI) devices that translate neural signals into digital commands are already helping patients with conditions like ALS, strokes, and paralysis to communicate and regain mobility.

But for Big Tech, the true prize lies in developing non-invasive consumer neurotechnology that can seamlessly integrate with devices and software – unlocking new frontiers in computing, gaming, virtual reality, and beyond.

Apple is exploring EEG sensors in AirPods that could monitor a user’s brain waves and mental state. Meta has a team working to decode human perception, using AI to reconstruct images just from people’s neural activity. And Amazon’s Alexa team is researching how to interpret brainwaves for voice-less voice control.

Even video game companies like Activision are eyeing the potential of neural interfaces that could immerse players’ minds directly into virtual environments.

Inside the Mind-Reading Moonshot
While the underlying BCI technology has existed for decades, the rise of advanced AI and machine learning capabilities is what’s truly catalyzing the mind-reading revolution.

By applying powerful neural networks to massive troves of brain signal data, companies aim to identify patterns that can then be translated into computer inputs for controls, communication, or even digital representations of sensory experiences like images and sound.

“We’re just scratching the surface of what neurotechnology combined with AI could enable,” said Dr. Lucy Green, a leading neuroscience researcher at Stanford University. “We may eventually be able to beam our thoughts directly into virtual spaces or machines, and create ultra-personalized experiences based on someone’s unique neural fingerprint.”

Naturally, such godlike capabilities raise serious ethical concerns around data privacy and consent. But for now, Green notes most development is still confined to medical use cases explicitly approved by patients.

Investment Opportunities Galore
For investors, the neurotechnology gold rush presents a multitude of intriguing opportunities across sectors. This includes established healthcare companies like Medtronic working on implantable BCIs, cutting-edge startups pioneering new interfaces and AI models, and even Big Tech bets on developing the next paradigm of human-machine interaction.

According to investment firm Ark, the entire “brain-computer interface” category could scale into a multi-trillion dollar annual revenue opportunity by 2030 if the technology meets its potential.

“It’s such a massive emerging space that will encompass hardware, software, AI capabilities, cloud computing, and likely subscription revenue streams,” said Ark analyst Nick Grous. “Any company that can establish an early lead could be looking at platform ownership.”

While the neuro-revolutions is still in its earliest innings, big bets are already being made behind the scenes at the world’s tech titans. For investors willing to grab a golden neural spike, it may represent one of the final frontiers of monetizing the human experience itself.

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Release – Tonix Pharmaceuticals Reports First Quarter 2024 Financial Results and Operational Highlights

Research News and Market Data on TNXP

May 13, 2024 4:30pm EDT

On track to submit NDA in the second half of 2024 for Tonmya™ for fibromyalgia; pre-NDA meeting with FDA scheduled for second quarter 2024

Commercial planning continues for U.S. launch of Tonmya, a potential new first-line, centrally-acting, non-opioid analgesic for the management of fibromyalgia

CHATHAM, N.J., May 13, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced financial results for the first quarter ended March 31, 2024, and provided an overview of recent operational highlights.

“Our near-term priority continues to be the submission of our New Drug Application (NDA) for Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, while continuing to build out our commercial strategy for the anticipated product launch in the event of FDA approval, which we currently estimate to occur in the second half of 2025,” said Seth Lederman, M.D., Chief Executive Officer of Tonix.

Dr. Lederman added, “The well-known treatment-limiting side effects of the three currently approved drugs have led to widespread patient dissatisfaction, creating what we believe is a significant opportunity for a new therapeutic. Tonmya has a differentiated mechanism of action and is generally free of common side effects associated with the currently approved products, including weight gain, fatigue, insomnia, increased blood pressure, gastrointestinal issues or sexual dysfunction. As such, we believe Tonmya, if approved, could become the treatment of choice for the approximately 10 million people in the U.S. suffering the debilitating effects of fibromyalgia.”

The Company is also advancing other key pipeline programs including those for immunology, obesity, eating disorders, infectious and rare diseases, many through a capital efficient strategy involving partnerships, grants and in-kind contributions.

Recent Highlights – Key Product Candidates*

Central Nervous System (CNS) Pipeline

Tonmya (also known as TNX-102 SL; cyclobenzaprine HCl sublingual tablets): a centrally-acting, non-opioid, small molecule analgesic taken once-daily at bedtime for the management of fibromyalgia (FM).

  • In January 2024, Tonix presented additional safety and tolerability data from the pivotal Phase 3 RESILIENT study that showed Tonmya treatment was not associated with increases in systolic or diastolic blood pressure or body weight, nor were there any reported sexual side effects. The Company had previously announced in December 2023 that the Phase 3 RESILIENT study, a registration-quality, double-blind, placebo-controlled study evaluating Tonyma met its pre-specified primary endpoint in the second of two positive Phase 3 clinical trials, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. Tonmya was well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed. In addition, Tonmya therapy showed activity on improving female sexual function relative to placebo with a nominal p-value=0.010 by the Changes in Sexual Functioning Questionnaire short-form, female version.
  • Tonix plans to submit an NDA to the FDA in the second half of 2024 for Tonmya for the management of fibromyalgia. In February 2024, Tonix announced the engagement of Rho, Inc. as our contract research organization (CRO) to support NDA submission.
  • In February 2024, Tonix announced statistically significant results from its clinical pharmacokinetic (PK) bridging study of Tonmya in healthy adult male and female ethnic Japanese and Chinese volunteers. Results indicate that key PK parameters of cyclobenzaprine are comparable in ethnic Japanese and Chinese volunteers to Caucasian volunteers from a prior PK study. Tonmya was generally well tolerated in the ethnic Japanese and Chinese healthy volunteers. The company expects these data to fulfill the requirement for a bridging study, and enables Tonix to rely on Phase 3 studies RESILIENT and RELIEF results to support regulatory filings for clinical studies in Japan and China where cyclobenzaprine is a new chemical entity (NCE). Tonix holds issued patents for market exclusivity rights of Tonmya in Japan, China, Hong Kong and Taiwan.
  • In March 2024, Tonix announced the selection of two contract manufacturing organizations (CMOs), including Almac Pharma Services, as dual supply sources for the potential launch and commercialization of Tonmya in the U.S.
  • In March 2024, Tonix selected EVERSANA, a leading provider of commercialization services to the global life sciences industry, to support the launch strategy and commercial planning of Tonmya in the U.S.
  • Tonix presented additional efficacy data from RESILIENT at the 6th International Congress on Controversies in Fibromyalgia in Brussels, Belgium, March 7-8, 2024. The data showed that Tonmya treatment resulted in an improvement in cognitive dysfunction, or ‘brain fog’, measured by the change in the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) memory item. The FIQ-R cognitive item showed nominal improvement in Tonmya-treated patients vs placebo-treated patients with a nominal p-value=0.001 and effect size of 0.31.

TNX-102 SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)

  • In February 2024, the Company announced the FDA cleared the Investigational New Drug (IND) application for the Phase 2 investigator-initiated OASIS trial to evaluate TNX-102 SL in reducing the severity of ASR and the frequency of ASD and PTSD. The trial is sponsored by the University of North Carolina Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense, which was awarded in September 2023. The proposed Phase 2, Optimizing Acute Stress Reaction Interventions with TNX-102 SL (OASIS) study will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department (ED) after a motor vehicle collision. The study will enroll approximately 180 trauma survivors at ED study sites in the U.S. Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL 5.6 mg or placebo.
  • Tonix anticipates the Phase 2 OASIS trial will initiate in the second quarter of 2024.

TNX-102 SL for the treatment of Fibromyalgia-Type Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)

  • In January 2024, the Company announced the online publication of a research paper in the Journal Pain. The article titled, “Chronic Overlapping Pain Conditions Increase the Risk of Long COVID Features, Regardless of Acute COVID Status,” by Bergmans, et al.1, found that patients with pre-existing chronic overlapping pain conditions (COPCs) had an increased risk of being diagnosed with symptoms of Long COVID1. Faculty at the University of Michigan directed the research. Commentary on the article titled, “A step towards better understanding chronic overlapping pain conditions” by Fitzcharles, et al,2 is in the same issue of the journal. COPCs include fibromyalgia, chronic fatigue syndrome, migraine headache, irritable bowel syndrome, endometriosis and low back pain. These results contribute to a growing body of evidence that common symptoms of Long COVID in many patients are at least partly driven by central nervous system mechanisms.

TNX-1300 (recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication

  • Tonix expects to initiate a Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in emergency rooms in the second quarter of 2024. In 2022, Tonix was awarded a Cooperative Agreement grant from the National Institutes of Health (NIH)’s National Institute of Drug Abuse (NIDA) to support development of TNX-1300.
  • TNX-1300 has been granted Breakthrough Therapy designation by the FDA.

TNX-1900 (intranasal potentiated oxytocin): small peptide in development through investigator-initiated studies for adolescent obesity, binge eating disorder, bone health in autism and social anxiety disorder (SAD).

  • TNX-1900 continues to be studied in four ongoing investigator-initiated Phase 2 studies as follows: Massachusetts General Hospital (MGH): (1) Phase 2 study for binge-eating disorder (BED); (2) Phase 2 study for adolescent obesity; (3) Phase 2 study for improving bone health in children with autism spectrum disorder (BOX); and at University of Washington, (4) Phase 2 study for social anxiety disorder (SAD). The BED study and the adolescent obesity study will investigate whether TNX-1900 has effects on eating behaviors in specialized populations.

Rare Disease Pipeline

TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)

  • In March 2024, Tonix announced that it received Rare Pediatric Disease designation from the FDA for TNX-2900 for the treatment of PWS. Tonix has an IND to support clinical development of TNX-2900 to treat PWS in children and adolescents. The planned Phase 2 study is a dose-finding study involving approximately 36 PWS patients divided into four groups with approximately nine per group. One group will receive placebo and three groups will receive different dosage regimens of TNX-2900. TNX-2900 for the treatment of PWS was granted Orphan Drug designation by the FDA in 2022. PWS is a genetic disorder that affects several body systems, with cognitive and behavioral symptoms including pathological over-eating beginning in childhood and leading to severe metabolic sequelae.

Immunology Pipeline

TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.

  • The first proposed indication for TNX-1500 is prophylaxis of organ rejection in adult patients receiving a kidney transplant; but multiple additional indications are possible, including autoimmune diseases. Two peer reviewed publications described the work with TNX-1500 at the Massachusetts General Hospital (MGH) on allogeneic transplants in animals.3,4
  • Preclinical studies have shown that TNX-1500 maintains the activity of first-generation monoclonal antibodies (mAbs), yet with reduced risk of thrombotic complications.3-5 Modeling studies from animal pharmacokinetic data3 predict a half-life of greater than three weeks for TNX-1500 in humans, which supports a monthly i.v. dosing regimen. This analysis together with TNX-1500’s activity and tolerability in animals, suggests that the protein engineering of TNX-1500’s Fc region has achieved its design goals.
  • In February 2024, Tonix announced the completion of the clinical stage of its Phase 1 single ascending dose study of TNX-1500 in healthy volunteers. The primary objectives of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous TNX-1500. This first-in-human study is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients.
  • In March of 2024, the MGH announced the first transplant of a genetically modified pig kidney into a living patient in collaboration with eGenesis, which produced the pig donors and used an anti-CD40L mAb from another company.5 Some of the pre-clinical work that supported the living human transplant was performed in collaboration with Tonix and used TNX-1500.6 The patient was able to return home after the transplant, but died after approximately two months.7

Marketed Products – Recent Highlights

  • As of April 1, 2024, Tonix completed the transition to becoming a fully integrated pharmaceutical company. Tonix Pharmaceuticals has implemented personnel, systems and contracts required to support a commercial organization and has assumed responsibility for distribution, selling and marketing of Zembrace SymTouch and Tosymra, as well as supply chain, regulatory and quality control of the two products.

Facilities – Recent Highlights

  • In the fourth quarter of 2023, Tonix engaged CBRE, an international real estate brokerage firm, to potentially find a strategic partner for, or buyer of, its Advanced Development Center (ADC) to align with the Company’s current business objectives and priorities. At this time, the Company does not have a commitment in place to sell the building. ADC, located in the New Bedford business park in Dartmouth, Massachusetts, is an approximately 45,000 square foot BSL-2 facility intended for clinical scale manufacturing of live-virus vaccines and biologics.

*All of Tonix’s product candidates are investigational new drugs or biologics and none have been approved for any indication.

Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

1 Bergmans RS, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003110.

2 Fitzcharles M-A, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003129.

Lassiter G., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.022

4 Miura S., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.025

5 Massachusetts General Hospital press release. March 21, 2024. “World’s First Genetically Edited Pig Kidney Transplant into Living Recipient Performed at Massachusetts General Hospital.” www.massgeneral.org/news/press-release/worlds-first-genetically-edited-pig-kidney-transplant-into-living-recipient (accessed March 29, 2024)

6 Anand, R.P., et al Nature. 622, 393–401 (2023). https://doi.org/10.1038/s41586-023-06594-4

7 Stoico, N. Boston Globe. May 11, 2023. “Mass Man who received first kidney transplant from genetically engineered pig has died, family says”.

Recent Highlights – Financial

As of March 31, 2024, Tonix had $7.0 million of cash and cash equivalents, compared to $24.9 million as of December 31, 2023. Net cash used in operations was approximately $17.6 million for first quarter 2024, compared to net cash used in operations of $32.9 million for the same period in 2023.

On April 1, 2024, the Company closed a financing with existing healthcare-focused institutional investors for upfront gross proceeds of approximately $4.4 million through a registered direct offering. 

First Quarter 2024 Financial Results

Net product revenue for the first quarter 2024 was approximately $2.5 million. Net product revenue consisted of combined net sales of Zembrace® SymTouch® and Tosymra®, which were acquired from Upsher-Smith Laboratories, LLC on June 30, 2023. Cost of Sales for the first quarter 2024 was approximately $1.7 million.

Research and development expenses for the first quarter 2024 were $12.9 million, compared to $26.5 million for the same period in 2023. This decrease is predominantly due to decreased clinical, non-clinical and manufacturing expenses.

General and administrative expenses for the first quarter 2024 were $9.3 million, compared to $7.4 million for the same period in 2023. The increase was primarily due to sales and marketing and the transition services expenses associated with the Company’s recently acquired marketed products offset by a decrease in financial reporting expenses.

Net loss was $(14.9) million, or $(0.18) per share, basic and diluted, for the first quarter 2024, compared to net loss of $(33.0) million, or $(3.21) per share, basic and diluted, for the same period in 2023. The basic and diluted weighted average common shares outstanding for the first quarter 2024 was 80,879,108 compared to 10,268,500 shares for the same period in 2023.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

View full release here.

Investor Contact

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

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

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151