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 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:
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Roman Safiyulin | Chief Corporate Development Officer
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.
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.
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.
Key Points: – Alibaba, JD.com, and Pinduoduo stocks soar after China announces new monetary stimulus measures. – The People’s Bank of China released $140 billion in liquidity by cutting interest rates and reserve requirements. – Skepticism remains over whether these measures will lead to long-term economic recovery.
China’s major e-commerce players—Alibaba, JD.com, and Pinduoduo—saw a significant stock surge on Tuesday after the People’s Bank of China (PBOC) unveiled its first major stimulus package since the pandemic. The central bank’s efforts aim to inject liquidity into the economy and spark growth amid ongoing challenges in the property market and reduced consumer demand.
Shares of Alibaba rose by 7%, while JD.com jumped 11%, and Pinduoduo saw an increase of nearly 10%. This sharp rise followed the PBOC’s announcement of key interest rate cuts and a reduction in reserve requirements for banks. These measures are expected to free up around 1 trillion yuan ($140 billion) in liquidity, making it easier for businesses and households to access loans at lower interest rates.
The stimulus comes at a critical time for China’s economy, which has been grappling with a cooling property market and weaker-than-expected demand in recent months. The government’s regulatory crackdown on tech companies over the last few years further compounded the struggles of companies like Alibaba and JD.com. At the height of this crackdown, Alibaba was slapped with a $2.6 billion fine for antitrust violations. Despite some recovery in 2024, these companies remain far from their 2020 stock price highs.
The tech sector, which includes major firms such as Baidu, Tencent, and NetEase, saw a broad rally following the announcement. The CSI 300, Shanghai Composite, and Hang Seng indexes all rose over 4%, reflecting optimism among investors about the new economic measures.
While the stock market responded favorably, some experts remain cautious about the long-term impact of China’s stimulus efforts. Charles Schwab’s chief global investment strategist, Jeffrey Kleintop, expressed doubts that these moves will be enough to stabilize China’s property market or significantly improve household incomes. “A lower mortgage rate on existing loans might help households, but it doesn’t do anything to arrest the decline in property prices or aggregate incomes or jobs,” said Kleintop. Wolfe Research chief economist Stephanie Roth echoed these sentiments, noting that similar announcements in the past have generated excitement but did not produce sustained economic improvements.
The stakes are high for China’s economy, which has long been seen as a key driver of global growth. As the world’s second-largest economy, a slowdown in China could have ripple effects across international markets. Investors are keenly watching whether these new stimulus measures will generate enough momentum to help China regain its footing and whether companies like Alibaba and JD.com can continue to capitalize on a more favorable economic environment.
Despite the skepticism, the stock surge offers a brief respite for Chinese e-commerce firms, which have faced intense pressure over the last few years. While these gains are encouraging, the question remains whether this upward trajectory will last or if more comprehensive measures will be needed to keep China’s economic recovery on track.
Experienced Life Sciences Executive Brings Strategic Expertise to Support Traws’ Further Transformation and Growth
Director James J Marino Also to Step Down from Traws Board After a Decade of Service
NEWTOWN, Pa., Sept. 20, 2024 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (Nasdaq: TRAW) (“Traws” or “the Company”), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases and cancer, today announced the appointment of Luba Greenwood as Director. In addition, Director James J. Marino is stepping down after nearly ten years of dedicated service, including four years as Chairman, due to other professional commitments.
“We are honored to welcome Luba Greenwood to the Traws Board,” said Iain Dukes, PhD, Executive Chairman of the Traws Board. “Luba brings a rich depth of experience as a Board Member, Investor, Strategic Advisor and Company Executive through her industry roles, including as a board member for public life science companies across a range of therapeutic areas, as Managing Partner of Binney Street Capital (BSC), and as Vice President of Global Business Development and M&A at Roche. As we begin the next phase of Traws’ development, including the advancement of our novel respiratory antiviral therapies through Phase 1 studies and the progression of our oncology strategy, we look forward to benefitting from Luba’s considerable expertise in strategy, corporate development and corporate governance.”
“I believe Traws is at a very important inflection point and I am excited to be part of the Company’s ongoing transformation,” said Luba Greenwood. “The Company has taken a very strategic approach to building and expanding its pipeline, starting with the April 2024 merger agreement with Trawsfynydd, one of the “Loch Companies” founded by the innovative i2020 Accelerator, supported by Torrey Pines Investments and Orbimed. Since April, the Company has delivered on its plan to advance the flu and COVID programs through Phase 1 dosing studies and initiate preparations to begin Phase 2 studies. In addition, it has progressed the development of its oncology strategy. I believe this is just the beginning for Traws and look forward to working with the Board and Management to create value for the Company’s investors and stakeholders.”
Dr. Dukes commented further, “On behalf of the Traws Board of Directors, I want to express our sincere gratitude to Jim for his dedicated and enduring service. As an active member of the biotech community, Jim has contributed valuable advice and leadership insight to the Company through the years, including four years as Chairman. We wish him all the best in his future endeavors.”
About Luba Greenwood Luba Greenwood is an accomplished life science professional with substantial experience as an investor, board member, company executive, entrepreneur and industry leader. Ms. Greenwood founded and currently serves as the Managing Partner of the Dana Farber Cancer Institute Venture Fund, Binney Street Capital (BSC). In addition, Ms. Greenwood serves on the Board of Directors of several biopharmaceutical companies. Previously, Ms. Greenwood held roles as a senior executive or advisor for private and public biopharmaceutical companies, including Kojin Therapeutics, LUCA Biologics, Inc, and leading healthcare organizations including the Dana-Farber Cancer Institute. Prior to that, Ms. Greenwood held senior leadership and strategic business and corporate development roles for Verily Life Sciences LLC, F. Hoffmann-La Roche Ltd., and the Roche Diagnostics Innovation Center, East Coast. Ms. Greenwood received a B.A. in Biology from Brandeis University and a J.D. from Northeastern University Law School.
About Traws Pharma, Inc.
Traws Pharma is a clinical stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes two potentially best-in-class oral small molecules in Phase 1 studies: 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 COVID19.
In the cancer program, Traws is utilizing a partnering strategy, supported by investigator sponsored studies, to advance the oncology program which includes the novel proprietary multi-kinase CDK4-plus inhibitor, narazaciclib, and the multi-kinase inhibitor targeting cell cycle proteins including PLK-1, rigosertib.
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. 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 Securities and Exchange Commission. 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.
Organon, a global healthcare company focused on improving women’s health, announced a major acquisition of Dermavant Sciences Ltd., a subsidiary of Roivant. This acquisition includes Dermavant’s innovative dermatologic therapy, VTAMA® (tapinarof) cream, 1%, which is approved for treating plaque psoriasis and is currently under FDA review for atopic dermatitis.
The acquisition enhances Organon’s presence in the U.S. dermatology market, adding to their international portfolio. This move aligns with Organon’s mission to provide treatments for conditions that disproportionately affect women. The inclusion of VTAMA cream, which addresses psoriasis and potentially atopic dermatitis, fits into their strategic goal of expanding access to effective therapies. Dermavant’s established commercial team will integrate with Organon’s market capabilities, further extending the product’s reach.
Dermavant’s VTAMA cream has been a game changer in the dermatology space. Approved in May 2022, it provides a non-steroidal, once-daily treatment option for plaque psoriasis, a condition that impacts over 8 million Americans. Unlike traditional steroid treatments, VTAMA cream is free of safety warnings, making it an appealing option for long-term use. The product is also under review to extend its use to treat atopic dermatitis, a common inflammatory skin condition affecting over 16.5 million adults and 9.6 million children in the U.S.
Organon’s acquisition of Dermavant not only strengthens its foothold in the U.S. market but also provides a new channel for global growth. Organon CEO Kevin Ali emphasized that this acquisition is part of their commitment to improving women’s health and that integrating Dermavant’s operations would accelerate VTAMA’s availability to patients. With Organon’s commercial scale, they expect to significantly increase patient access to this novel therapy globally.
The acquisition is structured with an upfront payment of $175 million, a milestone payment of $75 million contingent upon FDA approval for atopic dermatitis, and additional payments of up to $950 million tied to commercial milestones. Dermavant shareholders will also receive tiered royalties on net sales. The deal, subject to regulatory approvals, is expected to close by the fourth quarter of 2024.
The acquisition complements Organon’s portfolio of women’s health solutions, biosimilars, and established medicines, bringing a much-needed dermatological therapy into its fold. VTAMA cream has been a success, becoming the top branded topical for plaque psoriasis within just two months of its launch. Organon expects that the therapy will continue to grow, especially as the FDA considers its use for atopic dermatitis.
For Dermavant, the deal provides an opportunity for continued growth, with the support and scale of Organon to take VTAMA to new markets and potentially reach millions of patients globally.
With this acquisition, Organon is well-positioned to further expand its impact in dermatology, providing innovative treatments for plaque psoriasis and potentially atopic dermatitis. The company continues to focus on improving the lives of patients, particularly women, by offering accessible and effective healthcare solutions.
Key Points: – Camden National to acquire Northway Financial in an all-stock deal valued at $86.6 million. – The merger will create a regional banking leader in Northern New England with $7 billion in assets. – The transaction is expected to boost Camden National’s 2025 and 2026 earnings significantly.
In a significant regional banking merger, Camden National Corporation has announced plans to acquire Northway Financial, Inc. in an all-stock transaction valued at approximately $86.6 million. The merger positions Camden National as a dominant player in the Northern New England market, enhancing its footprint across New Hampshire and Maine.
This strategic acquisition merges two culturally aligned and geographically adjacent banks, creating a larger, publicly traded financial institution. The combined entity will boast 74 branches, $7 billion in total assets, $5.1 billion in loans, and $5.5 billion in deposits. With an expanded network, Camden National will enhance its customer service offerings, including higher lending limits, broader product availability, and improved technology investments.
Simon Griffiths, President and CEO of Camden National, highlighted the complementary nature of the merger, emphasizing shared values and a unified vision for the future. “This union will bolster our presence in New Hampshire, drive profitability, and increase shareholder value. We will also deliver broader product offerings and an enhanced customer experience for our clients,” he said.
Northway Financial, which holds approximately $1.3 billion in assets, is poised to benefit from the combined scale and resources. William Woodward, President and CEO of Northway, echoed Griffiths’ enthusiasm, stating, “This merger allows us to strengthen our foundations and strategically position ourselves for future growth in a competitive market.”
Financially, the merger is expected to significantly boost Camden National’s earnings per share (EPS). The transaction is projected to be 19.9% accretive to Camden National’s 2025 EPS and 32.7% accretive to its 2026 EPS. This demonstrates the financial appeal of the merger, with both institutions positioned for strong, long-term growth.
Under the terms of the agreement, Northway shareholders will receive 0.83 shares of Camden National common stock for each outstanding share of Northway stock, with the transaction valued at $31.46 per Northway share based on Camden National’s closing price on September 9, 2024. Post-merger, Camden National shareholders will own 86% of the combined company, while Northway shareholders will hold a 14% stake.
Griffiths emphasized that the merger allows Camden National to leverage its significant investments in technology to offer enhanced banking services to a larger customer base. “We are excited to work with Northway’s impressive team to build upon both of our successful community banking franchises,” he said.
The deal, unanimously approved by both companies’ boards of directors, is expected to close in the first quarter of 2025, pending regulatory approvals and shareholder consent. Following the merger, Camden National’s capital ratios will remain well above regulatory requirements, providing a stable foundation for continued growth.
Advisors for the deal include Raymond James & Associates, Inc. as Camden National’s financial advisor and Sullivan & Cromwell LLP as legal counsel. For Northway, Performance Trust Capital Partners LLC served as the exclusive financial advisor, and Goodwin Procter LLP acted as legal counsel.
This merger marks a new chapter for both banks, creating a stronger regional institution equipped to navigate the evolving financial landscape and deliver enhanced value to shareholders.
Investigator-initiated Phase 2 trial to evaluate TNX-102 SL’s potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) expected to begin third quarter 2024
Currently, no medication approved at or near point-of-care to treat patients suffering from traumatic events and support their long-term health
CHATHAM, N.J., Aug. 29, 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, presented clinical data on? acute stress reaction and prevention of PTSD data of TNX-102 SL in two poster presentations and presented preclinical data demonstrating automated high-throughput assay enabling screening for therapeutics to accelerate wound healing in a third poster presentation at the 2024 Military Health System Research Symposium (MHSRS), held August 26-29, 2024, in Kissimmee, Fla. Copies of the Company’s posters, titled:
“Two Clinical Trials of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Military-Related Posttraumatic Stress Disorder (PTSD) Provide Rationale to Study TNX-102 SL in the Aftermath of Trauma to Reduce Acute Stress Disorder (ASD) and Prevent PTSD”;
“Development of the AURORA Platform Trial Network to Test Interventions to Reduce Acute Stress Reaction Symptoms, and Illustration of Use Testing Sublingual Cyclobenzaprine TNX-102 SL”;
“Integrating Automated High-Throughput Scratch Assay and Cell Painting for Comprehensive Analysis of Cell Migration and Wound Healing”, are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
TNX-102 SL is being evaluated for the reduction in severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) when administered within 24 hours of trauma event. In two double-blind, randomized clinical trials of military-related PTSD, TNX-102 SL showed effects on sleep and PTSD symptoms in two and four weeks of treatment1. Supportive data on the effects of TNX-102 SL on reducing PTSD symptoms suggest early intervention immediately after trauma using TNX-102 SL has the potential to reduce ASR/ASD symptoms which are similar to those of PTSD2,3. TNX-102 SL has been well-tolerated with no recognized liability for tolerance or abuse. Data from these trials support testing of TNX-102 SL within 24 hours of index trauma for effects on acute stress reaction (ASR) symptoms and the incidence of PTSD. In the U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial conducted by the University of North Carolina under an investigator-initiated investigational new drug (IND) application, 14 days of bedtime TNX-102 SL will be dosed and tested in the immediate aftermath of motor vehicle collision. The study will test the potential for TNX-102 SL to target trauma-related sleep disturbance and its ability to facilitate recovery from ASR and to prevent PTSD. The results may ultimately provide military personnel with a new treatment option that, when administered in the early aftermath of a traumatic event to individuals with ASR symptoms, improves warfighter function.
“In previous trials, TNX-102 SL has been shown to improve sleep quality in PTSD and increased activity on sleep and stress-related symptoms in the first several weeks of treatment after a trauma event”, said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Since sleep disturbance plays a critical role in the development and maintenance of PTSD, sleep improvements may reorient the trajectory of posttraumatic pathology from acute trauma towards early recovery. The OASIS study is driven by the observation that the symptoms of ASR and PTSD are similar and by the hypothesis that TNX-102 SL’s effect on sleep quality may reduce ASR symptoms, potentially providing military personnel, veterans, and civilians with a new treatment option that, when administered in the early aftermath of a traumatic event, improves recovery, job performance, and quality of life.”
The investigator-initiated OASIS trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department (ED) after a motor vehicle collision. The trial plans to enroll approximately 180 trauma survivors at ED study sites around the U.S. Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL 5.6 mg or placebo. The first participant for the OASIS trial is expected to enroll in the third quarter of 2024.
The OASIS trial will build upon a foundation of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative. AURORA is a major national research initiative to improve the understanding, prevention and recovery of individuals who experience a traumatic event. AURORA is supported by funding from the National Institutes of Health (NIH), leading brain health nonprofit One Mind, private foundations, and partnerships with leading tech companies, such as Mindstrong Health and Verily Life Sciences, the healthcare arm of Alphabet, the parent company of Google.
Acute and chronic stress disorders can affect both civilian and military populations. According to the National Center for PTSD, in the U.S. about 60% of men and 50% of women experience at least one trauma in their lives.4 In the U.S. alone, one-third of ED visits (40-50 million patients per year) involve evaluation after trauma exposures, and in a 2014 study involving 3,157 US veterans, 87% reported exposure to at least one potentially traumatic event during their service.5 Moreover, as many as 500,000 U.S. troops who served in wars between 2001 and 2015 were diagnosed with PTSD.6
The third poster, titled “Integrating Automated High-Throughput Scratch Assay and Cell Painting for Comprehensive Analysis of Cell Migration and Wound Healing”, demonstrated optimization of a highly efficient scratch-wound assay development method. The scratch-wound assay, commonly used to study wound healing, has limitations that the study addresses by introducing an automated miniaturized high-throughput wound healing assay, enabling mass screening and identification of novel therapies for wound-healing. The screening technology was merged with cell-painting to allow discovery of morphological characteristics to identify mechanism of action of drugs for wound healing.
Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix 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. The company’s Good Manufacutring Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for 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 designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
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.
TNX-102 SL (cyclobenzaprine HCl sublingual tablets) has not been approved for any indication; (Tonmya™ is conditionally approved by FDA for the management of fibromyalgia)
Sullivan GM, et al. Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response. Psychiatry Res. 2021 Jul;301:113974.
Parmenter ME, et al. A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder. Psychiatry Res. 2024 (In Press). https://doi.org/10.1016/j.psychres.2024.115764
Goldstein RB, et al. Soc Psychiatry Psychiatr Epidemiol. 2016. 51(8):1137-48
Wisco BE, et al. J Clin Psychiatry. 2014. 75(12):1338-46
Thompson M. Time. 2015;185(12):40-3
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.
Key Points: – First non-tech U.S. company to reach $1 trillion market cap – Demonstrates strength of diversified, old-economy focused business model – Milestone achieved despite Buffett’s recent defensive market stance
Berkshire Hathaway has become the first non-technology company in the United States to achieve a market capitalization of $1 trillion. This milestone, reached on August 28, 2024, just days before Buffett’s 94th birthday, underscores the enduring success of the Oracle of Omaha’s investment philosophy and business acumen.
Berkshire Hathaway’s ascent to the trillion-dollar club is particularly noteworthy given its stark contrast to the other members of this exclusive group. While tech giants like Apple, Nvidia, Microsoft, Alphabet, Amazon, and Meta dominate the list, Berkshire stands out with its focus on traditional, old-economy sectors. The conglomerate’s diverse portfolio includes BNSF Railway, Geico Insurance, and Dairy Queen, among many others, showcasing the potential for substantial growth and value creation in industries often overlooked by modern investors.
The company’s shares have surged more than 27% in 2024, significantly outpacing the S&P 500’s performance. This impressive rally has been driven by the strength of Berkshire’s core businesses and strategic investments, including a substantial stake in Apple, which has contributed to recent gains.
Buffett’s journey with Berkshire Hathaway is a testament to his long-term vision and value investing principles. Taking control of what was initially a struggling textile business in the 1960s, Buffett transformed Berkshire into a sprawling empire with interests spanning insurance, railroads, retail, and energy. The company’s success is built on a foundation of prudent capital allocation, operational excellence, and an unmatched balance sheet.
Interestingly, this milestone comes at a time when Buffett has adopted a notably defensive stance in the market. Recent moves include divesting a significant portion of Berkshire’s stock holdings, including half of its Apple stake, while simultaneously building the company’s cash reserves to a record $277 billion as of June 2024. This cautious approach has raised eyebrows among market watchers, with some interpreting it as a signal of Buffett’s concerns about current economic conditions and market valuations.
Berkshire’s conservative cash management strategy is evident in its substantial holdings of short-term Treasury bills, valued at $234.6 billion at the end of the second quarter – a figure that exceeds even the U.S. Federal Reserve’s holdings. This approach reflects Buffett’s emphasis on capital preservation and readiness to act on potential opportunities.
One unique aspect of Berkshire Hathaway is the astronomical price of its Class A shares, which have never been split. This policy, according to Buffett, attracts and retains long-term, quality-oriented investors. The introduction of more affordable Class B shares in 1996 has allowed smaller investors to participate in Berkshire’s success while maintaining the exclusivity of the Class A shares.
As Berkshire Hathaway joins the trillion-dollar club, it serves as a powerful reminder of the potential for value creation in traditional industries. The milestone validates Buffett’s long-standing investment philosophy and demonstrates that patient, principled investing can yield extraordinary results, even in an era dominated by high-growth technology companies.
Looking ahead, market observers will be keenly watching how Berkshire navigates the evolving economic landscape. With its robust balance sheet, diverse portfolio, and Buffett’s legendary acumen, the company is well-positioned to continue its remarkable journey, potentially paving the way for other non-tech companies to follow in its footsteps.
Key Points: – Options market predicts unprecedented 9.8% stock move post-earnings – Potential $305 billion market value swing, largest in history – Nvidia’s earnings crucial for broader market performance
As Nvidia prepares to release its latest earnings report, the options market is bracing for what could be the largest earnings-related market value swing in history. Traders are anticipating a potential $305 billion fluctuation in Nvidia’s market capitalization, underscoring the chipmaker’s critical role in the artificial intelligence (AI) boom and its impact on the broader market.
Options pricing data from analytics firm ORATS indicates that traders expect Nvidia’s shares to move by approximately 9.8% on the day following its earnings announcement. This projected movement significantly surpasses the company’s average post-earnings move of 8.1% over the past three years and represents the largest expected swing for any Nvidia earnings report during this period.
The magnitude of this potential move is staggering when considering Nvidia’s current market capitalization of about $3.11 trillion. A 9.8% swing would translate to a market value change of around $305 billion – a figure that exceeds the entire market capitalization of 95% of S&P 500 companies, including giants like Netflix and Merck.
Nvidia’s outsized influence on the market is not limited to its own stock performance. The company’s chips, widely regarded as the gold standard in AI, have propelled its shares up by approximately 150% year-to-date. This remarkable growth has contributed to about a quarter of the S&P 500’s 18% gain in 2024, making Nvidia a critical driver of overall market performance.
Steve Sosnick, chief strategist at Interactive Brokers, aptly described Nvidia as “the Atlas holding up the market,” highlighting its substantial contribution to the S&P 500’s profitability. This analogy underscores the weight of expectations resting on Nvidia’s shoulders as it prepares to release its financial results.
Interestingly, the options market reveals a bias towards optimism among traders. Analysis from Susquehanna Financial indicates that traders are assigning a 7% probability to the stock rising more than 20% by Friday, compared to only a 4% chance of a 20% or greater decline. This sentiment suggests that investors are more concerned about missing out on potential gains than hedging against losses.
Christopher Jacobson, a strategist at Susquehanna Financial Group, attributes this phenomenon to the “continued uncertainty/optimism with regards to AI and the ultimate size of the opportunity.” The heightened interest in Nvidia among both institutional and retail investors has contributed to its elevated volatility compared to other trillion-dollar market cap companies.
The anticipation surrounding Nvidia’s earnings report reflects broader market dynamics and the pivotal role of AI in shaping investor sentiment. As the company prepares to unveil its latest financial results, the potential for a record-breaking market value swing serves as a testament to Nvidia’s position at the forefront of the AI revolution and its significance in the current investment landscape.
The outcome of Nvidia’s earnings report will likely have far-reaching implications, not only for the company’s shareholders but also for the broader technology sector and the overall market. As investors and analysts alike await the results, the unprecedented level of options activity surrounding Nvidia underscores the high stakes and intense scrutiny facing this AI chip giant.
Key Points: – Energy Fuels expands capabilities in medical isotope production – Acquisition addresses global shortage of crucial radioisotopes – Potential for repurposing existing process streams for cancer treatments
Energy Fuels Inc., a leader in uranium and rare earth elements production, has made a strategic move to address the growing demand for medical radioisotopes used in cancer treatments. On August 16, 2024, the company announced its acquisition of RadTran LLC, a private firm specializing in the separation of critical radioisotopes.
This acquisition marks a significant step for Energy Fuels in its plans to develop and produce medical isotopes, particularly radium-226 (Ra-226) and radium-228 (Ra-228). These isotopes are crucial components in the production of actinium-225 (Ac-225) and lead-212 (Pb-212), which are used in emerging targeted alpha therapies (TAT) for cancer treatment.
The global shortage of Ra-226 and Ra-228 has been a major hurdle in the advancement and commercialization of these potentially life-saving therapies. Energy Fuels’ move to acquire RadTran is aimed at addressing this shortage and positioning the company as a leader in this developing industry.
Mark Chalmers, President and CEO of Energy Fuels, emphasized the synergy between the two companies. The acquisition combines Energy Fuels’ processing capabilities at the White Mesa Mill – the only permitted and operating uranium mill in the United States – with RadTran’s intellectual property and expertise in radionuclide separation and concentration.
One of the most innovative aspects of this initiative is Energy Fuels’ potential to recover valuable isotopes from its existing process streams. This approach would essentially recycle material that would otherwise be lost to disposal, repurposing it for use in producing cancer treatments. This not only adds value to Energy Fuels’ operations but also contributes to more sustainable practices in the industry.
The acquisition builds upon a Strategic Alliance Agreement between Energy Fuels and RadTran that has been in place since July 2021. Under this agreement, the companies have been evaluating the feasibility of recovering Ra-226 and Ra-228 from existing uranium process streams at Energy Fuels’ White Mesa Mill in Utah.
Energy Fuels has already made significant progress in this area, receiving regulatory approval and licensing in 2023 for the concentration of R&D quantities of Ra-226 at the Mill. The company is currently completing engineering on its research and development pilot facility for Ra-226 production. In 2024, Energy Fuels plans to set up the first stages of the pilot facility and expects to produce R&D quantities of Ra-226 for testing by end-users.
Looking ahead, Energy Fuels aims to develop capabilities for commercial-scale production of Ra-226 and potentially Ra-228 in 2026-2028. This timeline is contingent on completing engineering design, securing sufficient offtake agreements, and receiving all required regulatory approvals.
The acquisition terms include an initial payment of $1.5 million in cash and $1.5 million in Energy Fuels common shares, along with a 2% royalty on future revenues from radium sales. Additional performance-based milestones could lead to up to $14 million more in cash and shares.
As part of the deal, Saleem Drera PhD, President and CEO of RadTran, will join Energy Fuels as Vice President of Radioisotopes, Radiological Systems, and Intellectual Property. Dr. Drera will lead efforts to integrate RadTran’s proprietary technology and drive innovation in medical radioisotope production.
The urgency of this acquisition is underscored by the extensive clinical research currently underway. Over 30 clinical trials are evaluating Ac-225, with several reaching final pre-approval stages for treating neuroendocrine tumors and leukemia. The current shortfall in Ac-225 production is delaying trials and challenging the transition to full commercial and clinical availability of these promising cancer therapies.
Energy Fuels’ strategic acquisition of RadTran represents a significant step towards addressing critical supply chain issues in the medical radioisotope industry. By leveraging existing facilities and expertise, the company is poised to play a crucial role in supporting the development of innovative cancer treatments, potentially improving outcomes for patients worldwide.
Crude oil prices have spiked nearly 3% as geopolitical tensions in the Middle East escalate and Libya halts its oil production. This sudden surge has caught the attention of investors worldwide, potentially signaling a shift in the energy market landscape.
West Texas Intermediate (WTI) crude jumped to over $77 per barrel, while Brent crude, the international benchmark, surpassed $80 per barrel. This sharp increase comes after a weekend of heightened tensions in the Middle East and a significant disruption in Libyan oil production.
The catalyst for this price surge appears to be twofold. First, Israel’s recent airstrike against Hezbollah’s rocket launching stations in Lebanon has exacerbated fears of a broader conflict involving Iran. The potential for Iranian military response has raised concerns about possible disruptions to global oil movements, a factor that could significantly impact supply chains and pricing.
Adding fuel to the fire, Iran-backed Houthi rebels continue their attacks on vessels in the Red Sea, with a Greek oil tanker being the latest casualty. These ongoing hostilities pose a substantial threat to one of the world’s most crucial shipping routes, potentially disrupting oil transportation and further tightening supply.
The second major factor driving oil prices higher is Libya’s decision to temporarily halt its oil production and exports. This move, prompted by a dispute over the leadership of Libya’s central bank, removes over 1 million barrels of daily crude production from the global market. The sudden supply shock has left traders scrambling to adjust their positions, contributing to the price surge.
For investors, these developments present both opportunities and risks. The energy sector, which has been under pressure due to concerns about global demand, may see a resurgence if oil prices continue their upward trajectory. Oil majors and exploration companies could benefit from higher crude prices, potentially boosting their profit margins and stock valuations.
However, the situation remains fluid. While oil prices have jumped over 5% in the past three sessions, long-term demand concerns still linger in the market. The global economic outlook, particularly in China, continues to cast a shadow over future oil demand projections.
Interestingly, despite the surge in crude prices, U.S. gasoline prices have continued their downward trend. The national average gasoline price currently hovers around $3.35 per gallon, significantly lower than both last month and last year. Industry experts attribute this to seasonal factors and expectations of reduced demand post-Labor Day.
Looking ahead, investors should keep a close eye on several key factors:
Developments in the Middle East, particularly any escalation involving Iran.
Libya’s oil production status and any potential resolution to the current dispute.
OPEC+ decisions on future production levels.
Global economic indicators, especially from major oil consumers like China and the U.S.
Hurricane season’s impact on U.S. Gulf oil production.
While the current price surge may offer short-term opportunities, prudent investors will need to weigh these against longer-term trends in oil demand and the ongoing global transition towards renewable energy sources.
As always, diversification and careful risk management remain key in navigating the volatile energy markets. With geopolitical tensions high and supply disruptions ongoing, the oil market promises to be an area of keen interest for investors in the coming weeks and months.
Key Points: – Mpox outbreaks boosts biotech stocks, especially those with related vaccines or treatments – Small biotech firms see volatile, dramatic gains, prompting caution from analysts – Renewed focus on infectious diseases may reshape biotech industry investments and partnerships
As the world grapples with a new outbreak of mpox, formerly known as monkeypox, the biotech sector is experiencing a surge of investor interest and market activity. The recent declaration of a global public health emergency by the World Health Organization (WHO) has thrust several biopharma companies into the spotlight, particularly those with potential treatments, vaccines, or diagnostic capabilities related to the virus.
The current outbreak, primarily driven by the more severe clade I variant, has already claimed over 1,100 lives in the Democratic Republic of Congo since January 2024. Unlike the 2022 outbreak, which was largely confined to specific communities, the new clade Ib variant appears to spread more easily through routine close contact, raising concerns about its potential for wider transmission.
This evolving situation has created a ripple effect across the biotech marketplace. Companies with mpox-related products or research pipelines have seen significant stock price movements. Danish biotech firm Bavarian Nordic, known for its mpox vaccine, has experienced a substantial surge in share value as it announces plans to ramp up production. Similarly, Emergent BioSolutions, with its approved smallpox treatment, has seen notable gains.
The diagnostic sector is also benefiting from the outbreak. Companies like Co-Diagnostics, which offers testing solutions, have seen increased investor interest. More dramatically, several smaller biotech firms focusing on infectious diseases have experienced explosive growth. Tonix Pharmaceuticals, Virax Biolabs, GeoVax, and Applied DNA Sciences have all seen their stock prices skyrocket, with some gaining over 100% in a single trading session.
However, industry analysts caution that such rapid gains may be unsustainable and could be subject to equally swift corrections. The volatile nature of biotech stocks, especially during disease outbreaks, is well-documented. Investors are advised to approach these opportunities with caution, considering both the potential for breakthrough developments and the risks associated with speculative investments.
The mpox outbreak is also rekindling interest in the broader infectious disease sector. Many investors and industry observers are drawing parallels to the early days of the COVID-19 pandemic, which saw unprecedented growth in vaccine and therapeutic development. This has led to increased funding and research initiatives across the biotech industry, not just for mpox-specific solutions, but for a wide range of potential emerging infectious diseases.
Large pharmaceutical companies are also taking notice. While they may not experience the same dramatic stock movements as smaller, more specialized firms, many are reassessing their infectious disease portfolios and considering new investments or partnerships in this area.
The outbreak is also highlighting the importance of preparedness and rapid response capabilities in the biotech sector. Companies with flexible platforms for developing vaccines or therapeutics are gaining attention from both investors and potential government partners.
As the situation continues to evolve, the biotech marketplace is likely to see ongoing volatility and opportunities. The mpox outbreak serves as a reminder of the critical role the sector plays in global health security and its potential for both scientific advancement and financial growth.
While the immediate focus remains on addressing the current health emergency, the long-term implications for the biotech industry could be significant. The outbreak may lead to increased investment in infectious disease research, new partnerships between academia and industry, and a renewed emphasis on global health preparedness – all factors that could shape the biotech landscape for years to come.
