September 2024 - Channelchek

Release – Traws Pharma Announces Positive Topline Phase 1 Results for COVID Candidate, Ratutrelvir, an Oral Mpro Inhibitor

Posted on September 30, 2024September 30, 2024 by aweinsoff@channelchek.com

Ratutrelvir was well-tolerated for 10 days and achieved consistent plasma levels in the predicted therapeutic window, without the need for co-administration of ritonavir

Phase 2a study expected to begin in H1 2025 in patients with COVID

Improving COVID care is an ongoing need, with approximately 50,000 US deaths in 2023

NEWTOWN, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing potential oral small molecule therapies for the treatment of respiratory viral diseases, today announced positive topline Phase 1 results for its potential best-in-class COVID (SARS-CoV-2) candidate, ratutrelvir, an oral inhibitor of the Main protease (Mpro).

“Topline data indicate that administration of ratutrelvir, our product candidate for COVID, as monotherapy, for 10 days to healthy volunteers, showed no treatment related adverse events and demonstrated consistent plasma drug levels in the predicted therapeutic window. We are especially pleased by ratutrelvir’s ability to achieve plasma concentrations that are considerably above the EC₉₀ against a comprehensive panel of SARS-CoV-2 viruses, without the need for ritonavir co-administration that can be a source of drug-drug interactions and potential severe side effects,” said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma. “These data provide us with further indication that ratutrelvir has the potential to be a potent, best-in-class, once-a-day, single-dose, 10-day antiviral therapy for COVID. This profile contrasts with Paxlovid^™, an approved Mpro inhibitor, which requires co-administration of ritonavir, a metabolic inhibitor. We believe that ratutrelvir’s ritonavir-free regimen has the potential to reduce the burden of treatment, especially for patients with underlying medical conditions. Based on the Phase 1 data, we have selected the dose for our Phase 2a study, expected to begin in H1 2025.”

“As we near the fifth anniversary of the pandemic, it is notable that, despite the wide availability of approved antiviral therapies, COVID was a major cause of mortality in the US in 2023, with approximately 50,000 deaths¹,” said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). “We believe it is important for new COVID therapies to have a simple treatment regimen that can be used broadly, especially in patients who are at higher risk of serious symptoms or who are over 65 years of age with underlying medical conditions including heart disease, kidney disease, and chronic lung disease². In addition, we consider activity against resistant viruses and low risk of clinical rebound to be important features of potential new COVID therapies. Our enthusiasm for ratutrelvir’s potential to meet the need for improved COVID treatment has been enhanced by the Phase 1 data.”

“Our goal for ratutrelvir is to effectively treat COVID, limit the symptoms of infection, and lower the risk for clinical rebound,” said C. David Pauza, PhD, Chief Scientific Officer for Traws Pharma. “Preclinical studies, presented at the annual International Conference on Antiviral Research in 2024 (ICAR2024), showed that ratutrelvir monotherapy has differentiated activity compared to nirmatrelvir against a range of drug-resistant viruses. Also, preclinical testing in animal models showed that levels of ratutrelvir in the lung were higher than in plasma. Phase 1 data show that ratutrelvir achieved consistent plasma levels in the predicted therapeutic window, with a pharmacokinetic profile that may reduce the likelihood of clinical rebound.”

Topline Phase 1 Results
The Phase 1 trial (NCT06402136, conducted in Australia) was designed as a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple ascending doses (SAD and MAD) of ratutrelvir, administered as a capsule formulation in 56 healthy, COVID-negative, adult volunteers, randomized three-to-one (eight subjects per dosing group). The SAD portion of the study evaluated five ratutrelvir dose levels; the MAD segment evaluated two ratutrelvir dose levels, administered once daily for 10 days.

This first-in-human study showed no treatment related adverse events reported up to the highest dose. Topline data also showed that once-daily administration of ratutrelvir maintained plasma drug levels within the predicted therapeutic window. Preclinical studies, presented at the annual International Conference on Antiviral Research in 2024 (ICAR2024), showed that ratutrelvir demonstrated differentiated activity compared to nirmatrelvir against a range of SARS-CoV-2 variants, based on a comparison of EC₅₀ values.

About Ratutrelvir
Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity. Ratutrelvir (also previously known as 83-0060 or TRX-01) was designed as an inhibitor of the SARS-CoV-2 Main protease (Mpro or 3CL protease). It has demonstrated in vitro activity against the original strain of the virus as well as the delta and omicron variants, and is more active than nirmatrelvir (Pfizer’s Mpro inhibitor, co-packaged with ritonavir as PAXLOVID^™) in preclinical studies. Based on preclinical studies, ratutrelvir did not require co-administration with a metabolic inhibitor, such as ritonavir, which inhibits human cytochrome P450 (CYP) 3A4. Because of this, ratutrelvir is expected to avoid ritonavir-associated drug-drug interactions and potential resulting severe side effects, which may permit wider patient use. The drug candidate’s pharmacokinetic (PK) profile, including the ability to achieve plasma levels within the predicted therapeutic window, as demonstrated in the Phase 1 study, may also enable a once daily treatment regimen and reduce the likelihood of clinical rebound.

Source information:

About Traws Pharma, Inc.
Traws Pharma is a clinical stage biopharmaceutical company developing potential oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes two Phase 1 potentially best-in-class oral small molecules in development: tivoxavir marboxil, a novel oral antiviral drug candidate for influenza and avian flu, targeting the influenza cap-dependent endonuclease, and ratutrelvir, targeting Mpro (3CL protease) for COVID.

In the cancer program, Traws is utilizing a partnering strategy, supported by investigator sponsored studies, to advance two novel proprietary multi-kinase inhibitors, narazaciclib, targeting CDK4+, and rigosertib, targeting cell cycle proteins including PLK-1.

Traws is committed to delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a focus on product safety and a commitment to patients in need or that are specifically vulnerable, we aim to build solutions for important medical challenges and alleviate the burden of viral infections and cancer.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and Traws regulatory plans for ratutrelvir. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, collaborations, merger integration, market conditions and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Traws Pharma Contact:

Mark Guerin
Traws Pharma, Inc.
267-759-3680
www.trawspharma.com

Investor Contact:

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

Release – The GEO Group Announces Date for Third Quarter 2024 Earnings Release and Conference Call

Posted on September 30, 2024September 30, 2024 by dburczyk@noblecapitalmarkets.com

Research News and Market Data on GEO

Earnings Release Scheduled for Thursday, November 7, 2024 Before the Market Opens
Conference Call Scheduled for Thursday, November 7, 2024 at 11:00 AM (Eastern Time)

BOCA RATON, Fla.–(BUSINESS WIRE)–Sep. 30, 2024– The GEO Group, Inc. (NYSE:GEO) (“GEO”) will release its third quarter 2024 financial results on Thursday, November 7, 2024 before the market opens. GEO has scheduled a conference call and simultaneous webcast for 11:00 AM (Eastern Time) on Thursday, November 7, 2024.

Hosting the call for GEO will be George C. Zoley, Executive Chairman of the Board, Brian R. Evans, Chief Executive Officer, Mark Suchinski, Chief Financial Officer, Wayne Calabrese, President and Chief Operating Officer, and James Black, President, GEO Secure Services.

To participate in the teleconference, please contact one of the following numbers 5 minutes prior to the scheduled start time:

1-877-250-1553 (U.S.)
1-412-542-4145 (International)

In addition, a live audio webcast of the conference call may be accessed on the Webcasts section of GEO’s investor relations home page at investors.geogroup.com. A webcast replay will remain available on the website for one year.

A telephonic replay will also be available through November 14, 2024. The replay numbers are 1-877-344-7529 (U.S.) and 1-412-317-0088 (International). The passcode for the telephonic replay is 7169822. If you have any questions, please contact GEO at 1-866-301-4436.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240927105230/en/

Pablo E. Paez 1-866-301-4436
Executive Vice President, Corporate Relations

Source: The GEO Group, Inc.

Eledon Pharmaceuticals (ELDN) – Virtual Roadshow Discussions Focus On Kidney Transplantation

Posted on September 30, 2024September 30, 2024 by cpereira@noblefcm.com

Monday, September 30, 2024

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.

Client Meetings Answered Questions About Tegoprubart. We held a Virtual Non-Deal Road Show with Eledon’s CEO, Dr. DA Gros. The discussions with clients covered tegoprubart history of development, mechanism of action, clinical trials, and its upcoming milestones. Some of the points raised and common questions are highlighted below.

The Phase 2 BESTOW Trial Completed Enrollment In August. Eledon announced the completion of enrollment for its Phase 2 BESTOW trial that tests tegoprubart against tacrolimus for prevention of kidney transplant rejection. The enrollment was completed ahead of the expected YE2024 timeframe due to higher than expected interest from the transplant surgeons.

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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.

Gogo to Acquire Satcom Direct, Creating Global Leader in In-Flight Connectivity

Posted on September 30, 2024October 1, 2024 by slightbourne@noblecapitalmarkets.com

Key Points:
– Gogo will acquire Satcom Direct for $375 million in cash and 5 million shares of Gogo stock, expanding its in-flight connectivity solutions.
– The combined company will offer multi-band, multi-orbit satellite solutions for business aviation and military/government markets.
– The deal is expected to close by the end of 2024, providing cost synergies and significant revenue growth opportunities.

In a significant move to bolster its position in the global in-flight connectivity market, Gogo Inc. (NASDAQ: GOGO) has announced the acquisition of Satcom Direct, a leading provider of geostationary satellite in-flight services for business aviation (BA) and military/government mobility markets. The transaction, valued at $375 million in cash and five million shares of Gogo stock, positions Gogo as the only multi-orbit, multi-band global connectivity provider catering to all segments of the BA market and government mobility sector.

The acquisition, which includes potential earn-out payments of up to $225 million based on future performance, will create significant synergies and accelerate Gogo’s long-term growth. Satcom Direct is expected to generate $485 million in revenue for 2024 with EBITDA margins of approximately 17%. With this acquisition, Gogo aims to expand its total addressable market to the 14,000 business aircraft located outside of North America.

Oakleigh Thorne, Chairman and CEO of Gogo, commented, “This transaction accelerates our growth strategies, expanding our global reach while enabling us to offer integrated satellite solutions. By combining Satcom Direct’s existing capabilities with Gogo’s Galileo LEO (Low Earth Orbit) solution, we can now offer unmatched performance to business aviation and military customers.”

Satcom Direct’s portfolio includes advanced geostationary satellite (GEO) and L-band offerings, which will be integrated into Gogo’s Galileo LEO satellite solutions. This multi-orbit approach will cater to both North American and international customers, providing premium connectivity options for all segments of the business aviation market. The deal also strengthens Gogo’s entry into the military and government mobility vertical, adding new revenue streams and diversifying the company’s customer base.

Chris Moore, President of Satcom Direct, expressed excitement about the acquisition, stating, “We are thrilled to be joining forces with Gogo, which shares our commitment to customer service and innovation. Together, we will unlock opportunities for new technologies, delivering even greater value to our clients worldwide.”

The acquisition not only boosts Gogo’s market presence but also delivers immediate financial benefits. The deal is expected to be accretive to earnings and free cash flow per share from the start, with projected annual run-rate cost synergies of $25-30 million within two years post-closing. Pro forma 2024 revenue for the combined company is expected to reach $890 million, with adjusted EBITDA margins of around 24%.

Looking ahead, Gogo anticipates long-term annual revenue growth of approximately 10%, driven by the combined strengths of its existing customer base and Satcom Direct’s extensive sales and service network. Additionally, the deal opens opportunities for technology upgrades and faster installations, thanks to the combined installed base of over 12,000 aircraft globally.

The transaction, unanimously approved by Gogo’s Board of Directors, is set to close by the end of 2024, pending regulatory approval and customary closing conditions.

Fed’s Key Inflation Gauge Drops to 2.2% in August, Paving Way for Further Rate Cuts

Posted on September 27, 2024September 27, 2024 by slightbourne@noblecapitalmarkets.com

Key Points:
– The PCE price index showed inflation at 2.2% in August, the lowest since early 2021.
– Core PCE, excluding food and energy, rose 2.7%, staying steady with July’s reading.
– The lower-than-expected inflation could prompt additional interest rate cuts by the Fed.

The Federal Reserve’s key inflation measure, the Personal Consumption Expenditures (PCE) price index, posted a notable drop to 2.2% in August, marking the lowest inflation rate since February 2021. This is a clear signal that inflation is continuing its downward trend, positioning the Fed for future interest rate cuts.

The PCE index, which measures the cost of goods and services in the U.S. economy, saw just a 0.1% increase in August from the previous month. Economists had expected the year-over-year inflation rate to settle at 2.3%, but the actual figure came in even lower, underscoring a continued easing of inflation pressures. This development further supports the Fed’s pivot toward focusing on labor market support, rather than aggressive inflation-fighting measures.

The core PCE index, which excludes the volatile food and energy prices, rose by 0.1% in August and maintained an annual increase of 2.7%, in line with economists’ expectations. This core measure is a preferred gauge for the Fed when assessing long-term inflation trends. The steady core inflation number is likely to reinforce the Fed’s decision-making, signaling that while inflation is cooling, there are still pressures, especially in key sectors such as housing.

The recent PCE numbers are particularly crucial as they come on the heels of the Fed’s decision to cut its benchmark interest rate by half a percentage point, lowering it to a target range of 4.75%-5%. It was the first time since March 2020 that the Fed made such a significant rate cut, deviating from its typical quarter-point moves.

With inflation easing closer to the Fed’s long-term 2% target, the latest data could pave the way for additional interest rate reductions by the end of the year. Many market participants expect the Fed to make another cut by half a percentage point before the year’s end, followed by further reductions in 2025.

Fed officials have gradually shifted their focus from solely managing inflation to also supporting the U.S. labor market. Recent data has indicated some softening in the job market, with Fed policymakers noting the need to balance between maintaining price stability and ensuring continued employment growth.

Chris Larkin, managing director of trading and investing at E-Trade from Morgan Stanley, commented on the positive inflation news, saying, “Inflation continues to keep its head down, and while economic growth may be slowing, there’s no indication it’s falling off a cliff.”

Despite the positive inflation report, personal income and spending data were weaker than expected. Personal income increased by 0.2%, while spending also rose by 0.2% in August. Both figures fell short of their respective forecasts of 0.4% and 0.3%. These softer numbers suggest that while inflation may be cooling, consumer demand remains fragile, posing potential risks to broader economic growth.

Looking ahead, investors and market watchers will be closely monitoring upcoming U.S. data, including personal consumption expenditures and jobless claims, for further clues about the Fed’s next move.

Release – Tonix Pharmaceuticals Announces Issuance of U.S. Patent Covering the Subcutaneous Delivery of FDA-Approved Zembrace® SymTouch® to Treat Migraines

Posted on September 27, 2024September 27, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

September 27, 2024 7:00am EDT

New patent expected to provide market exclusivity into 2036

Zembrace^® SymTouch^® (sumatriptan succinate injection) 10mg is indicated for the acute treatment of migraine in adults

CHATHAM, N.J., Sept. 27, 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 that the United States Patent and Trademark Office issued U.S. Patent No. 12,097,183 to the Company on September 24, 2024. The patent, entitled “Pharmaceutical Composition for Treating Migraine”, claims use of a pre-filled autoinjector comprising a composition of Zembrace^® SymTouch^® for treating migraines via subcutaneous administration. This patent, excluding possible patent term extensions, is expected to provide protection into 2036.

“We are excited to announce the issuance of this additional patent, providing additional protection for our exclusive marketing and sale of FDA-approved Zembrace^® for the treatment of migraines,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe Zembrace^® is a compelling non-oral option for people who suffer with migraines.”

Tonix recently launched a new educational campaign, “Does Your Migraine Pill Work Every Time?” The goal of the campaign is to educate patients and their healthcare providers on the benefits of non-oral migraine medications including nasal and injectable treatment options. Non-oral migraine medications, such as injectables and nasal sprays, do not rely on the digestive system to be absorbed and can offer the potential for faster relief from migraine symptoms in as little as 10 minutes.

Migraine often requires patients to advocate for themselves to develop an effective migraine treatment plan. Empowering patients to understand why they are experiencing delayed or inconsistent relief from oral medications and educating them on other migraine treatment options could ultimately improve their management of migraine symptoms and ultimately enhance their quality of life.

For example, gastroparesis is common before, during, and sometimes in between migraine attacks. Gastroparesis can slow or even block the absorption of oral medications causing delayed, incomplete, or no migraine symptom relief. Tonix will launch a new disease education website, www.gpmigraine.com, for patients who want to learn more about gastroparesis and migraine and why their oral medications do not work.

Dr. Lederman continued, “Tonix is dedicated to educating patients and their healthcare providers on gastroparesis and how non-oral medicines including nasal and injectable medications can help patients manage their migraines. We hope to inspire patients to optimize their migraine treatment plan with non-oral medications.”

About Migraine

Nearly 40 million people in the United States suffer from migraine¹ and it has been recognized as the second leading cause of disability in the world^2,3. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia)⁴.

¹Law, H. Z., Chung, M. H., Nissan, G., Janis, J. E., & Amirlak, B. (2020). Hospital Burden of Migraine in United States Adults: A 15-year National Inpatient Sample Analysis. Plastic and reconstructive surgery. Global open, 8(4), e2790. https://doi.org/10.1097/GOX.0000000000002790

²GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2018;17(11):954-976.

³Steiner, T.J., Stovner, L.J., Jensen, R. et al. Lifting the Burden: the Global Campaign against Headache. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain 21, 137 (2020).

⁴Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to submit a New Drug Application (NDA) to the FDA in October 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development 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, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA) to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD, instrumental in progressing this development. 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.

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.

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

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Indication/Limitations of Use

ZEMBRACE^® SymTouch^® (sumatriptan succinate) and TOSYMRA^® (sumatriptan spray) are indicated for the acute treatment of migraine with or without aura in adults. ZEMBRACE SymTouch and TOSYMRA should only be used where a clear diagnosis of migraine has been established. ZEMBRACE SymTouch and TOSYMRA are not indicated for the prevention of migraine attacks or for the treatment of cluster headache.

Important Safety Information CONTRAINDICATED IN PATIENTS WITH:

Ischemic coronary artery disease (CAD) or coronary artery vasospasm, including Prinzmetal’s angina
Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
History of stroke, transient ischemic attack (TIA), or hemiplegic or basilar migraine
Peripheral vascular disease
Ischemic bowel disease
Uncontrolled hypertension
Recent (i.e., within 24 hours) use of ergotamine-containing or ergot-type medication, or another 5-HT₁ agonist
Concurrent or recent (within 2 weeks) use of a MAO-A inhibitor
Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
Severe hepatic impairment

WARNINGS AND PRECAUTIONS

Myocardial ischemia/infarction, Prinzmetal’s angina: These events may occur even in patients without known cardiovascular disease. Perform cardiac evaluation in triptan-naïve patients with multiple risk factors and, if satisfactory, administer first dose of ZEMBRACE SymTouch and TOSYMRA in a medically-supervised setting
Arrhythmias: Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT₁ agonists. Discontinue ZEMBRACE SymTouch and TOSYMRA if these disturbances occur
Sensations of chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Commonly occur after treatment with 5-HT₁ agonists and are usually non-cardiac in origin. Perform a cardiac evaluation in patients with cardiac risk
Cerebrovascular Events: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT₁ agonists, and some have resulted in fatalities. Discontinue ZEMBRACE SymTouch and TOSYMRA if a cerebrovascular event occurs. Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions
Other Vasospasm Reactions: 5-HT₁ agonists, including ZEMBRACE SymTouch and TOSYMRA, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT₁ agonist, rule out a vasospastic reaction before using ZEMBRACE SymTouch and TOSYMRA
Medication Overuse Headache: Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse head- ache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary
Serotonin Syndrome: May occur with triptans, including ZEMBRACE SymTouch and TOSYMRA, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs). The onset of symptoms usually occurs within minutes to hours of receiving a new or greater dose of a serotonergic medication. Discontinue ZEMBRACE SymTouch and TOSYMRA if serotonin syndrome is suspected
Increases in Blood Pressure: Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported in patients treated with 5-HT₁ agonists. Monitor blood pressure in patients treated with ZEMBRACE SymTouch and TOSYMRA
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred in patients receiving sumatriptan. Such reactions can be life threatening or fatal. ZEMBRACE SymTouch and TOSYMRA are contraindicated in patients with a history of hypersensitivity reaction to sumatriptan
Seizures: Seizures have been reported following administration of sumatriptan, with or without predisposing factors. ZEMBRACE SymTouch and TOSYMRA should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold
Local Irritation (TOSYMRA only): Local irritative symptoms were reported in approximately 46% of patients with TOSYMRA in an open-label trial which allowed repeated use of TOSYMRA over the course of 6 months. The most common of which were application site reaction (eg., burning sensations in the nose), dysgeusia, and throat irritation. Approximately 0.5% of the cases were reported as severe.

ADVERSE REACTIONS

The most common adverse reactions (≥5% and > placebo) were injection site reactions (ZEMBRACE SymTouch only), tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness/paresthesia.

To report SUSPECTED ADVERSE REACTIONS, contact TONIX Medicines, Inc, at 1-888-869-7633 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information, including Instructions for Use, for ZEMBRACE SymTouch and TOSYMRA.

Source: Tonix Pharmaceuticals Holding Corp.

Released September 27, 2024

Dow Hits Record High on Tame Inflation Report, Boosts Small Caps

Posted on September 27, 2024September 27, 2024 by slightbourne@noblecapitalmarkets.com

Key Points:
– Dow reaches a new record high on the back of a moderate inflation report, indicating that lower interest rates may be on the horizon.
– Small-cap stocks surge, with the Russell 2000 index climbing 1.5% due to favorable low-rate conditions.
– S&P 500 and Nasdaq dip slightly, but remain near record highs from recent sessions.

The Dow Jones Industrial Average reached a new record high on Friday, as investors reacted positively to a tame inflation report that signaled the potential for lower interest rates. This news provided a significant boost to small-cap stocks, with the Russell 2000 index surging by 1.5%, marking its highest point in a week. The broader market remained buoyant, though the S&P 500 and Nasdaq Composite both dipped slightly. However, both indexes held near record highs reached in recent trading sessions, underscoring overall market strength.

The small-cap rally is particularly notable given the sector’s sensitivity to interest rates. As inflationary pressures ease, small-cap stocks, which generally benefit more from lower borrowing costs, are poised for stronger performance. Investors are increasingly optimistic that the Federal Reserve will continue to lower interest rates, creating a more favorable environment for smaller companies that are more reliant on domestic growth and financing.

At the core of this market optimism is the notion that inflation has been effectively tamed, leading investors to believe that the economy is on track for a “soft landing.” According to Liz Young Thomas, head of investment strategy at SoFi, “The market is pricing in a soft landing, with the assumption that inflation has been defeated and the Fed can lower rates without causing harm to the economy.” This belief has led to increased confidence across various sectors, but the biggest gains have been seen in small-cap stocks, which stand to benefit more directly from a low-interest-rate environment.

The latest report from the Commerce Department highlighted moderate growth in consumer spending, which, paired with cooling inflation, further bolstered market sentiment. In addition, the University of Michigan’s final reading on September consumer sentiment came in at 70.1, surpassing economists’ expectations of 69.3. This data added fuel to the market rally, particularly in sectors such as energy and financials. However, the real standout was the Russell 2000 index, which tracks small-cap companies that typically perform well when borrowing costs are lower.

At midday, the Dow Jones Industrial Average was up 0.45%, adding 191.49 points to reach 42,366.60. The S&P 500 dipped by 0.06%, while the Nasdaq Composite slipped by 0.32%, driven largely by declines in the technology sector. Despite these slight pullbacks, both the S&P 500 and Nasdaq remain near their record highs from earlier in the week, reflecting underlying market strength.

The Russell 2000’s performance is especially significant, as small-cap stocks are often more volatile and sensitive to shifts in the economic landscape. With the Federal Reserve expected to maintain or increase rate cuts, these stocks are increasingly seen as attractive investments. As of Friday, investors had begun to favor a larger 50 basis point rate cut at the Fed’s next meeting, with a 52.1% probability of this move, up from a near 50/50 chance before the inflation data was released.

Energy stocks were among the best performers on Friday, with eight out of the 11 S&P 500 sectors gaining ground. In contrast, technology stocks, which had fueled much of the recent market rally, pulled back. Shares of Nvidia fell by 2.56%, weighing heavily on the tech-heavy Nasdaq.

The shift in investor focus towards small-cap stocks underscores the broader market’s expectations of prolonged monetary easing, which could provide a sustained tailwind for these companies. With borrowing costs expected to decline further, small caps like those tracked by the Russell 2000 are positioned to capitalize on lower rates, potentially outperforming their larger counterparts in the coming months.

As inflation continues to cool and rate cuts loom, small caps could be at the forefront of the next market rally, driven by investor optimism in a more favorable economic environment.

Release – GDEV Shares Recent Sustainability Achievements

Posted on September 26, 2024September 26, 2024 by aweinsoff@channelchek.com

Research News and Market Data on GDEV

September 26, 2024 – Limassol, Cyprus – GDEV Inc. (NASDAQ: GDEV), an international gaming and entertainment company (“GDEV” or the “Company”), has released its 2023 Sustainability Report, highlighting the Company’s continued contribution to the communities we serve and the Company’s sustainability achievements towards generating a positive impact from gaming for all our stakeholders.

GDEV is committed to environmental stewardship, corporate social responsibility, and robust corporate governance. The report introduces updates to the GDEV Sustainability Strategy, including the Games for Good Philosophy and policies on supporting local communities where we operate.

Andrey Fadeev, Founder and CEO of GDEV, commented, “It is personally gratifying to me that our games not only entertain but also contribute to meaningful positive outcomes. From engaging players in eco-friendly practices to raising awareness on crucial social issues, we are transforming gaming into a powerful force for good. Who knew making a difference could be so much fun?”

Natasha Braginsky Mounier, Chairperson of the Board of Directors, added, “This report reflects our deep belief in the long term value of sustainable business practices. We demonstrate this through ongoing innovative and educational initiatives, engaging our workforce and the local communities. We are pleased with the progress we’ve made and will continue to seek effective solutions for the challenges of our times.”

GDEV’s 2023 Sustainability Report can be found in our Sustainability section on the company’s website: https://www.gdev.inc/sustainability.

ABOUT GDEV

GDEV is a gaming and entertainment holding company, focused on development and growth of its franchise portfolio across various genres and platforms. With a diverse range of subsidiaries including Nexters and Cubic Games, among others, GDEV strives to create games that will inspire and engage millions of players for years to come. Its franchises, such as Hero Wars, Island Hoppers, Pixel Gun 3D and others have accumulated over 550 million installs and $2.5 bln of bookings worldwide. For more information, please visit www.gdev.inc

CONTACTS:

Investor Relations

Roman Safiyulin | Chief Corporate Development Officer

investor@gdev.inc

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Certain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws. Such statements are based on current expectations that are subject to risks and uncertainties. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.

The forward-looking statements contained in this press release are based on the Company’s current expectations and beliefs concerning future developments and their potential effects on the Company. There can be no assurance that future developments affecting the Company will be those that the Company has anticipated. Forward-looking statements involve a number of risks, uncertainties (some of which are beyond the Company’s control) or other assumptions. You should carefully consider the risks and uncertainties described in the “Risk Factors” section of the Company’s 2023 Annual Report on Form 20-F, filed by the Company on April 29, 2024, and other documents filed by the Company from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, 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 may be required under applicable securities laws.

Release – Cocrystal Pharma Advances Oral Pan-Viral Protease Inhibitor CDI-988 into Phase 1 Multiple-Ascending Dose Cohorts

Posted on September 26, 2024September 26, 2024 by aweinsoff@channelchek.com

Research News and Market Data on COCP

September 26, 2024

BOTHELL, Wash., Sept. 26, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces dosing of the first subjects in the multiple-ascending dose (MAD) portion of the Phase 1 study with CDI-988, its potent, broad-spectrum, oral pan-viral protease inhibitor. Topline study results are expected in late 2024 or early 2025. CDI-988 was specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery platform technology and is being developed as the first-in-class pan-viral antiviral for the treatment of viral gastroenteritis and COVID-19 caused by noroviruses and coronaviruses, respectively.

“We are delighted to advance the clinical evaluation of CDI-988, a novel direct-acting antiviral (DAA) targeting the viral proteases of noroviruses and coronaviruses,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “Multiple-ascending dose results will further evaluate safety and tolerability of this potentially groundbreaking antiviral therapeutic.”

This randomized, double-blind Phase 1 study, which is being conducted at a single center in Australia, is evaluating the safety, tolerability and pharmacokinetics of orally administered CDI-988 compared with placebo in healthy adults. In July 2024 Cocrystal reported favorable safety and tolerability results from study participants in the single-ascending dose (SAD) portion of the trial. All SAD participants completed the study with no reported serious adverse events or severe treatment-emergent adverse events. No clinically significant observations were noted in laboratory assessments, physical exams or electrocardiograms.

About Noroviruses

Human noroviruses are highly contagious, constantly evolving, extremely stable in the environment and associated with debilitating illness. Symptoms include vomiting and diarrhea, with or without nausea and abdominal cramps. Norovirus infection can be much more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency. In the U.S. alone, noroviruses are responsible for an estimated 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, according to the Centers for Disease Control and Prevention (CDC). The estimated annual burden of noroviruses to the U.S. at $10.6 billion, according to the National Institutes of Health (NIH). Outbreaks occur most commonly in semi-closed communities such as nursing homes, hospitals, cruise ships, schools, disaster relief sites and military settings. To date, no antiviral treatment or vaccine is approved for norovirus infections.

Coronaviruses Including SARS-CoV-2 and its Variants

Coronaviruses (CoV) are a family of viruses that historically have been associated with a wide range of symptoms, ranging from no symptoms at all to more severe disease that includes pneumonia, acute respiratory distress syndrome (ARDS), kidney failure and death. By targeting the viral replication enzymes and protease, Cocrystal believes it is possible to develop an effective treatment for all coronaviruses, including SARS-CoV-2 (which causes COVID-19) and its variants, ARDS and Middle East Respiratory Syndrome (MERS). The ability of an asymptomatic individual to transmit infection heightened the public health challenge of COVID-19.

About Cocrystal Pharma, Inc.

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

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential efficacy of CDI-988 against coronaviruses and noroviruses, the expected timing of topline results of the MAD portion of the CDI-988 study, and the potential market for such product candidate. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to obtain regulatory authority for and proceed with clinical trials including the recruiting of volunteers for the MAD cohorts of the CDI-988 Phase 1 study by our clinical research organizations and vendors, the results of such studies, our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, and potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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

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

# # #

Source: Cocrystal Pharma, Inc.

Released September 26, 2024

Super Micro Shares Plunge 12% as DOJ Investigates Alleged Accounting Violations

Posted on September 26, 2024September 26, 2024 by slightbourne@noblecapitalmarkets.com

Key Points:
– DOJ opens probe into Super Micro amid allegations of accounting manipulation.
– Shares tumble 12% following the report, building on earlier losses after a Hindenburg Research short position.
– Super Micro, a major AI player, is under scrutiny as the investigation unfolds.

Super Micro Computer, Inc. (SMCI) saw its shares plummet over 12% on Thursday after a report emerged that the U.S. Department of Justice (DOJ) has initiated an investigation into the company. The investigation follows allegations from Hindenburg Research regarding possible accounting manipulation, which has cast a cloud over the company in recent months.

The DOJ probe, which is reportedly in its early stages, was first disclosed by The Wall Street Journal. While few specifics have been released, the inquiry is focusing on potential accounting violations linked to the company’s financial practices. CNBC has not yet independently verified the claims made by Hindenburg or the details of the DOJ’s investigation.

Super Micro, which designs and manufactures computers and servers for applications such as artificial intelligence (AI) algorithms, has been a significant player in the AI revolution. The company boasts major partnerships with industry leaders like Nvidia, AMD, and Intel. However, the recent news of the DOJ probe has shaken investor confidence, leading to a sharp sell-off in its stock.

The roots of this controversy trace back to late August when Hindenburg Research, a well-known short-seller, announced its short position in Super Micro, citing “fresh evidence of accounting manipulation.” Hindenburg’s report sent shockwaves through the market, causing Super Micro’s stock to plunge by nearly 20% at the time. Compounding matters, the company missed its deadline to file its annual report with the U.S. Securities and Exchange Commission (SEC), further fueling concerns. It remains unclear whether the delay is related to the allegations made by Hindenburg.

As the investigation gains traction, reports suggest that a prosecutor from the U.S. Attorney’s office in San Francisco has sought information about a former employee who previously accused Super Micro of engaging in questionable accounting practices. This has intensified scrutiny on the company’s financial integrity, leading many investors to reassess their positions.

Super Micro, founded in 1993, has enjoyed substantial growth in recent years, particularly benefiting from the AI boom. Its hardware is critical for the infrastructure powering websites, data storage, and AI computing. The company’s shares had been on an upward trajectory, driven by strong demand in the tech sector, until these allegations surfaced.

The fallout from the DOJ probe marks another chapter in a tumultuous period for Super Micro. It remains to be seen how this investigation will unfold and what its ultimate impact will be on the company’s financial health and market standing. At this stage, neither the DOJ nor Super Micro has offered substantial comment on the matter.

The investigation raises broader questions about corporate governance and financial transparency in tech companies. As Super Micro continues to face these allegations, the company will need to work swiftly to restore investor confidence and navigate the potential legal challenges ahead.

V2X (VVX) – Noble Conference Presentation

Posted on September 26, 2024September 26, 2024 by cpereira@noblefcm.com

Thursday, September 26, 2024

For more than 70 years, Vectrus has provided critical mission support for our customers’ toughest operational challenges. As a high-performing organization with exceptional talent, deep domain knowledge, a history of long-term customer relationships, and groundbreaking technical expertise, we deliver innovative, mission-matched solutions for our military and government customers worldwide. Whether it’s base operations support, supply chain and logistics, IT mission support, engineering and digital integration, security, or maintenance, repair and overhaul, our customers count on us for on-target solutions that increase efficiency, reduce costs, improve readiness, and strengthen national security. Vectrus is headquartered in Colorado Springs, Colo., and includes about 8,100 employees spanning 205 locations in 28 countries. In 2021, Vectrus generated sales of $1.8 billion. For more information, visit the company’s website at www.vectrus.com or connect with Vectrus on Facebook, Twitter, and LinkedIn.

Joe Gomes, CFA, 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.

Noble Conference. We hosted V2X President and CEO Jeremy Wensinger at our Basic Industries Virtual Investor Conference. Mr. Wensinger touched on the Company’s end-to-end capabilities, including full lifecycle solutions, large backlog, positive future opportunity, and an expanding addressable market. A replay of the presentation, including Q&A can be viewed at: https://www.channelchek.com/videos/v2x-inc-vvx-noble-capital-markets-basic-industries-virtual-conference-replay

Expanding Addressable Market. With the combination of Vectrus and Vertex, V2X is now able to pursue opportunities previously out of either individual company’s reach, expanding V2X’s addressable market. The prime example of this is the July award of the $3.7 billion War Fighter Training Readiness contract, which combined strengths of both the old Vectrus and Vertex into a winning proposal, even against stiff competition.

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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).

Snail (SNAL) – An Opportunistic Entry Point

Posted on September 26, 2024September 26, 2024 by cpereira@noblefcm.com

Thursday, September 26, 2024

Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.

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

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Stock slips below $1. The SNAL shares are down roughly 40% YTD. We believe this slide is an over reaction to the company’s “miss” in first half earnings, which was largely related to deferred revenue. The company has a favorable long term fundamental outlook and is financially healthy, with a sizable cash position and positive cash flow generation.

Fundamentals do NOT appear broken. We expect company fundamentals to improve over the next eighteen months. In 2024, revenue and adjusted EBITDA are expected to increase to $88.7 million and $12.3 million, respectively, up from $60.9 million and negative $9.7 million in 2023. In 2025, we anticipate revenue and adjusted EBITDA to reach $105.0 million and $24.5 million. This growth is backed by a number of exciting developments, including the rollout of more Down Loadable Content (DLC) packages for Ark: Survival Ascended, which should help alleviate noise surrounding deferred revenue.

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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).

MustGrow Biologics Corp. (MGROF) – Transitioning from R&D to Commercialization

Posted on September 26, 2024September 26, 2024 by cpereira@noblefcm.com

Thursday, September 26, 2024

Joe Gomes, CFA, 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.

Update and Presentation. On Tuesday, we had the opportunity to participate in a webinar presentation and interview with MustGrow’s management providing an update on the current progress of the Company’s pipeline and its future. Key takeaways of the update, in our view, were the progress towards sales of its TerraSante product, advancing towards commercialization of its TerraMG product, and the expansion of the Company’s intellectual property portfolio.

TerraSante. The Company has been underway in its planning for larger-scale production on TerraSante. The Company had its initial commercial production run in 2023 and had its first sales during the third quarter this year. Management is seeing strong initial interest in the product, primarily from California, and has the opportunity for multiple applications per year for various crop markets, which could potentially triple acre coverage. We believe that we will continue to see more state approvals for the product in the near term as management has focused on getting such approvals.

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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).