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

Posted on 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 world2,3. 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.

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released September 27, 2024

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

Posted on 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 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 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

# # #

Primary Logo

Source: Cocrystal Pharma, Inc.

Released September 26, 2024

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

Posted on 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 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.


Get the Full Report

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.

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. 

Snail (SNAL) – An Opportunistic Entry Point

Posted on 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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*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. 

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

Posted on 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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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.

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. 

Hemisphere Energy (HMENF) – Hemisphere Provides an Operational Update and Declares a Special Dividend

Posted on by cpereira@noblefcm.com


Thursday, September 26, 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.

Operational update. Hemisphere has drilled six horizontal wells into its southeast Alberta Atlee Buffalo F and G pools over the past two months, with two wells left to drill as part of its summer program. Drilling operations are expected to be completed early in the fourth quarter with wells put into production as they are tied-in through the remainder of the year. Hemisphere has also commenced polymer injection at its new pilot enhanced oil recovery project in Marsden, Saskatchewan. Management anticipates that it could take until mid-2025 to increase reservoir pressure and to evaluate the production response at the three producers.

Updating estimates. Crude oil prices have weakened since our last update. We have lowered our 2024 adjusted funds flow (AFF) and earnings per share (EPS) estimates to C$43.8 million and C$0.31, respectively, from C$45.4 million and C$0.35. Our third and fourth quarter EPS estimates were lowered by C$0.02 each to C$0.08 and C$0.06, respectively, based on average per barrel WTI crude oil prices of $75.69 and $71.20. While futures prices suggest 2025 WTI pricing in the $68 to $70 per barrel range, we are leaving our 2025 estimates unchanged for now based on a WTI crude oil price of $74.95 per barrel.


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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.

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. 

Great Lakes Dredge & Dock (GLDD) – Noble Conference Presentation

Posted on by cpereira@noblefcm.com


Thursday, September 26, 2024

Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

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 Great Lakes CFO Scott Kornblau at our Basic Industries Virtual Investor Conference. Mr. Kornblau touched on the Company’s recent strong operating performance, backlog, positive future opportunity, the ship building program, and capital structure. A replay of the presentation, including Q&A can be viewed at: https://www.channelchek.com/videos/great-lakes-dredge-dock-company-gldd-noble-capital-markets-basic-industries-virtual-conference-replay

Operating Performance. Great Lakes has completed three successful quarters in a row and the Company believes the strong operating outlook will continue for the foreseeable future, driven by record budgets at the U.S. Army Corps, supplemental funding for hurricane impacted areas now being released, and other additional funding for large projects expected in the second half of the decade.


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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.

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. 

AZZ Inc. (AZZ) – Highlights from the Noble Virtual Basic Industries Equity Conference.

Posted on by cpereira@noblefcm.com


Thursday, September 26, 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.

New manufacturing facility is on schedule and on budget. AZZ Inc. participated in Noble’s Virtual Basic Industries Conference on September 25. AZZ is the leading independent provider of hot-dip galvanizing and coil coating solutions to a broad range of end markets. With AZZ Precoat Metals’ new manufacturing facility in Washington, Missouri expected to be completed in fiscal year 2025, we expect the facility to contribute to top-line growth in fiscal year 2026 while capital expenditures decline. Approximately 75% of the facility’s production is already committed that we estimate could generate approximately $50 million to $60 million in revenue. A link to the presentation replay is here.

Declining debt balance and cost of capital. Based on the company’s strong first quarter fiscal year 2025 results and outlook, we have assumed AZZ will pay down $90 million of debt this fiscal year, or at the high end of the guidance range. On September 24, AZZ executed a fourth amendment to its existing credit agreement and reduced the interest rate of the Term Loan B by 75 basis points to the Adjusted Term Secured Overnight Financing Rate (SOFR) plus 250 basis points.


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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.

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. 

Gevo Acquires CultivateAI to Strengthen Verity’s Carbon Accounting Solutions

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Gevo acquires CultivateAI for $6 million to boost Verity’s carbon tracking capabilities.
– The acquisition will accelerate revenue growth and provide advanced agricultural analytics.
– CultivateAI’s SaaS platform integrates real-time agricultural data, driving sustainability and profitability for farmers.

Gevo, Inc. (NASDAQ: GEVO), a renewable energy and carbon solutions company, has announced the acquisition of Cultivate Agricultural Intelligence, LLC (“CultivateAI”) for $6 million in cash. This strategic acquisition will bolster Gevo’s Verity business unit, accelerating the development of Verity’s carbon tracking capabilities, while integrating new revenue streams from CultivateAI’s agricultural data and analytics platform.

CultivateAI, a cloud-based software as a service (SaaS) platform, provides agricultural operators with real-time analytics, helping them make data-driven decisions to improve productivity, sustainability, and profitability. With expected 2024 revenue of $1.7 million and positive cash flow, CultivateAI is already a proven business. Gevo aims to leverage this platform to strengthen Verity’s carbon accounting and tracking solutions, focusing on carbon abatement across sectors like food, feed, fuels, and industrial markets.

Dr. Paul Bloom, Head of Verity and Chief Carbon Officer of Gevo, expressed excitement about the acquisition: “Adding CultivateAI and its inventive approach to Verity will help us grow revenue by providing the most complete set of data-driven analytics services to farmers, agronomists, and researchers. This acquisition accelerates our ability to deliver value to our customers.”

Verity’s primary focus is creating an innovative platform that tracks, verifies, and empirically values carbon intensity throughout the entire carbon lifecycle. With the addition of CultivateAI’s tools and customer base, Verity will extend its reach beyond biofuels and tap into new revenue streams. This integration is poised to strengthen Gevo’s role in promoting sustainability and profitability, particularly for farmers and agricultural service providers.

Gevo’s CEO, Dr. Pat Gruber, emphasized the broader implications of the acquisition: “We are constantly looking for development opportunities that bring new revenue streams to the company. As Verity accelerates, we expect to see more customer relationships and growth opportunities, supporting our mission to build a circular economy.”

CultivateAI’s advanced platform, with its real-time data capabilities, will allow Verity to offer the highest quality carbon abatement solutions while helping clients understand their operations better. The SaaS platform enables farm operators, agronomists, and researchers to access timely, reliable insights, enhancing their ability to manage resources efficiently and sustainably.

Gevo is committed to converting renewable energy and biogenic carbon into sustainable fuels and chemicals with a net-zero or better carbon footprint. With this acquisition, the company takes another step toward its mission of fostering a sustainable, circular economy while driving shareholder value through scalable revenue growth.

As Verity continues to expand its platform, the integration of CultivateAI will not only help improve agricultural operations but will also support the carbon footprint reduction efforts in various industries. By offering clients innovative, data-driven solutions, Gevo aims to lead the way in sustainability-focused business practices.

Mortgage Refinance Boom Takes Hold as Weekly Demand Surges 20%

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Refinancing applications surged 20% in one week amid declining mortgage rates.
– Mortgage rates fell to 6.13%, the lowest in two years, driving demand.
– The refinance share of mortgage applications reached 55.7% of total demand.

Mortgage refinance activity has seen a significant surge as homeowners across the United States rush to take advantage of falling interest rates. According to the Mortgage Bankers Association (MBA), applications to refinance home loans soared by 20% last week compared to the previous week, driven by the continuous decline in mortgage rates. This marks a stunning 175% increase in refinance demand from the same time last year.

The average contract interest rate for 30-year fixed-rate mortgages with conforming loan balances ($766,550 or less) dropped to 6.13% from 6.15%. Though the change may seem small, the cumulative effect of eight straight weeks of declining rates is pushing homeowners to seize the opportunity for potential savings. Joel Kan, vice president and deputy chief economist at MBA, highlighted this ongoing trend: “The 30-year fixed rate decreased for the eighth straight week to 6.13%, while the FHA rate decreased to 5.99%, breaking the psychologically important 6% level.”

Refinance applications now make up 55.7% of all mortgage applications, showcasing how appealing the current rates are for homeowners. However, while the percentage rise is significant, the overall level of refinancing activity remains modest when compared to previous refinancing waves. The ongoing economic environment, combined with seasonal slowdowns in homebuying, has contributed to this pattern.

Despite the seasonal slowdown, mortgage applications to purchase homes rose just 1% over the last week, demonstrating that homebuyers are still facing challenges like high home prices and limited inventory. These factors have kept the pace of new home purchases relatively stable, with purchase applications only 2% higher than the same week last year.

One interesting takeaway from the latest data is that average loan sizes for both refinancing and home purchases have reached record highs. The overall average loan size hit $413,100 last week, the largest in the survey’s history. This reflects both the continued rise in home values and the larger loan amounts that homeowners are seeking, particularly in high-cost markets.

Looking ahead, mortgage rates have not seen significant movement at the start of this week. However, they may react as more pressing economic data, such as jobs reports and inflation numbers, are released in the coming weeks. Any developments in the broader economic outlook could influence the future path of mortgage rates, either stabilizing them or prompting further fluctuations.

For now, homeowners who have yet to take advantage of the current low rates are eyeing the market closely, as more savings could be realized with additional rate cuts. With mortgage rates remaining near their lowest levels in two years, the refinancing boom may continue to gain traction, especially if the Federal Reserve implements further rate cuts to counter slowing economic growth.