Key Points: – U.S. stock indexes drop, with Nasdaq down over 1% after Iran’s missile attack on Israel. – Defense stocks rise as oil prices surge amid geopolitical tensions. – Investors grow cautious, monitoring U.S. job data and port strikes.
U.S. stock markets took a sharp turn downward on Tuesday as news broke of Iran launching a barrage of ballistic missiles at Israel, heightening tensions in the Middle East. The Nasdaq Composite led the decline, falling by over 1%, while the broader market also saw losses, reflecting growing investor caution in the face of geopolitical instability. The Dow Jones Industrial Average fell by 0.2%, and the S&P 500 dropped 0.75%.
The attack by Iran is seen as retaliation for Israel’s ongoing military campaign against Hezbollah, Iran’s ally in the region. In response to the missile strikes, President Joe Biden directed the U.S. military to support Israel’s defense and to shoot down any missiles aimed at the country, as confirmed by the White House National Security Council.
While the broader market felt the impact of the escalating conflict, shares in the defense sector surged. Companies like Northrop Grumman and Lockheed Martin saw their stock prices rise, as investors shifted focus to the increased demand for defense and military technology in light of the conflict. The S&P 500 Aerospace and Defense Index rose by more than 1%, hitting a new record high.
Energy companies also benefitted from the geopolitical unrest, with oil prices rising alongside the tensions. Exxon Mobil gained 2.2% as West Texas Intermediate crude oil climbed over 4%. The possibility of further supply disruptions in the Middle East, which produces a significant portion of the world’s oil, pushed investors into energy stocks, which historically serve as a hedge during times of geopolitical uncertainty.
On the other hand, airline stocks like Delta Air Lines experienced losses, reflecting concerns over potential disruptions in travel and higher fuel costs. Delta’s shares dropped by 1%, as investors anticipated a tightening of air travel conditions due to escalating tensions in the region.
“This situation highlights the variety of risks the market is currently facing, from slowing employment to geopolitical tensions,” noted Walter Todd, Chief Investment Officer at Greenwood Capital. “The market is vulnerable to shocks like this, and it’s reacting accordingly.”
The heightened geopolitical risk comes at a time when U.S. markets were already grappling with several economic uncertainties. On Monday, the three major indexes had posted strong gains for September and for the third quarter, but Tuesday’s developments prompted a reversal of that trend. In addition to the conflict in the Middle East, investors are also closely watching economic data related to U.S. job openings and manufacturing activity, which rebounded in August but still signaled broader concerns about the health of the economy.
Increased market volatility followed the news, with the CBOE Volatility Index, also known as the VIX or “fear gauge,” jumping by two points to 18.74. Earlier in the session, the index had reached a three-week high of 20.73, indicating a growing sense of uncertainty among investors.
Meanwhile, the looming East Coast and Gulf Coast port strikes, which began Tuesday, added another layer of complexity to the market’s reaction. The strike has halted approximately half of the nation’s ocean shipping, potentially exacerbating economic disruptions and creating further uncertainty for policymakers at the Federal Reserve as they assess the state of the economy.
Investors will be watching closely as more economic data is released later in the week, particularly the U.S. jobless claims report on Thursday and the monthly payrolls data on Friday. With market sentiment already rattled by geopolitical events, these figures could further influence the outlook for future Federal Reserve interest rate cuts.
Key Points: – U.S. East Coast port workers are poised to strike, potentially halting container traffic from Maine to Texas. – The strike could cost the U.S. economy an estimated $5 billion a day, directly impacting shipping and transportation stocks. – Companies in logistics, shipping, and transportation sectors could face stock volatility due to supply chain disruptions.
In what could become the largest port disruption in decades, U.S. East and Gulf Coast port workers are set to strike, posing a significant threat to the nation’s economy and potentially shaking up transportation and shipping stocks. The International Longshoremen’s Association (ILA), representing 45,000 workers, has not reached an agreement with the United States Maritime Alliance (USMX), and with no talks scheduled, a strike appears imminent. The last coast-wide ILA strike was in 1977, and this impending strike could have far-reaching consequences.
This labor dispute could cost the U.S. economy as much as $5 billion per day, halting the flow of goods in and out of the nation’s busiest ports, from Maine to Texas. As retail businesses prepare for the holiday season, the strike threatens to create major supply chain bottlenecks, increasing the pressure on companies that depend on timely shipping and logistics to meet demand.
For transportation and shipping stocks, the impact could be immediate. Stocks of companies like FedEx, UPS, XPO Logistics, and JB Hunt Transport Services could see increased volatility as the strike unfolds. Container shipping companies such as Matson, ZIM Integrated Shipping Services, and Danaos Corporation are also likely to face challenges due to disruptions in port activity. With nearly 100,000 containers expected to be stuck at the ports of New York and New Jersey alone, delays in deliveries could result in higher costs, slower operations, and potentially reduced earnings for logistics and transportation companies.
The strike could also have a ripple effect across transportation stocks beyond just those involved in logistics. Companies in industries dependent on port activity, such as retailers, manufacturers, and automotive suppliers, may see disruptions in their supply chains. This could create downward pressure on stock prices across a variety of sectors, further compounding the economic damage.
The broader shipping sector is also vulnerable to sudden shifts in stock value, particularly if delays cause shipping costs to rise. Companies with heavy exposure to East Coast and Gulf Coast ports may face increased operational costs as they are forced to reroute goods through alternative ports or transport modes, impacting their bottom line. Analysts are watching shipping stocks closely, and any prolonged strike could lead to earnings downgrades for several transportation companies.
As the labor dispute remains unresolved, investors in transportation and shipping stocks will need to monitor developments closely. Prolonged disruptions could have a significant effect on quarterly earnings, stock performance, and overall sector sentiment. With no negotiations planned, the situation is on a knife’s edge, and any news about progress—or the lack thereof—will likely trigger swift movements in related stocks.
MCLEAN, Va., Oct. 1, 2024 /PRNewswire/ — V2X, Inc. (NYSE: VVX) announces its selection for the $11.9 billion Defense Logistics Agency (DLA) J6 Enterprise Technology Services 2.0 (JETS 2.0) contract, securing its place amongst a select group of providers.
“In today’s rapidly evolving digital landscape, vigilance is paramount. V2X is proud to support the Defense Logistics Agency by delivering critical cybersecurity and IT modernization services to uphold their mission,” said Jeremy C. Wensinger, President and Chief Executive Officer of V2X.
Under the JETS 2.0 contract, V2X will provide a range of advanced IT solutions, including cloud services and cybersecurity services to the DLA. This indefinite-delivery/indefinite-quantity contract spans an initial five-year base period, with the potential for an additional five-year option, supporting both U.S. and international Defense Department operations with essential IT services.
About V2X
V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Media Contact Angelica Spanos Deoudes Director, Corporate Communications Angelica.Deoudes@goV2X.com 571-338-5195
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations IR@goV2X.com
CHANDLER, Ariz. – Oct. 1, 2024– Comtech (NASDAQ: CMTL) (the “Company”), a global technology leader, today announced SES Space & Defense recently awarded the Company an initial order for Comtech’s market-leading software-defined SLM-5650B and other next-generation modems. Initial quantities under this new contract are expected to be delivered over the next year.
“In today’s threat environment, secure, resilient, and ubiquitous connectivity is critical to maintaining an information advantage across all domains,” said John Ratigan, Interim CEO of Comtech. “This contract award further demonstrates the trust of SES Space & Defense in Comtech’s ability to deliver next-generation digital solutions. O3b mPOWER is among the world’s most innovative satellite constellations, and we are thrilled to partner with SES Space & Defense as they pave the way for modernized military satellite communications (“SATCOM”) operations.”
“We choose customer mission success first. Comtech’s SLM modem series includes features that are unique and critical to our customers’ missions,” said David Fields, President and CEO of SES Space & Defense. “It is important that Comtech is part of the O3b mPOWER service infrastructure. Their experience developing and manufacturing defense-oriented modems that are ‘allied by design’ with footprints in many domestic and international programs of records make it an easy decision.”
Developed and manufactured at its headquarters in Chandler, AZ, Comtech’s SLM-5650B is the Company’s current Wideband Global SATCOM-certified modem designed to deliver critical communications services for commercial backhaul and government and military applications. The software-defined SLM-5650B currently supports multiple critical DoD and NATO waveforms including DVB-S2X, the preferred waveform for SES’ O3b mPOWER constellation, with the ability to easily add more waveforms and functions to meet emerging mission needs.
Comtech’s portfolio of U.S. sovereign defense technologies and services, including the Company’s SLM-5650B and next-generation modems, align with the Space Force Commercial Space Strategy and deliver capabilities that will enhance Combined Joint All Domain Command and Control operations. Comtech’s expansive portfolio of defense and security technologies is designed to continuously evolve over time to enable digitalized SATCOM infrastructures and integrate services across blended military and commercial networks to significantly enhance mission effectiveness in future all-domain operations.
About Comtech
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.
About SES Space & Defense
SES Space & Defense is a wholly-owned subsidiary of SES and is exclusively focused on building, managing, and supporting the most advanced satellite network solutions for the U.S. Government. SES Space & Defense uses a proven multi-operator network integration and management capability, a broad global terrestrial network, as well as access to SES’s multi-orbit satellite fleet. It also offers U.S. Department of Defense customers the essential tools in cybersecurity for mission-critical operations, coupled with a proven track record in governance and compliance. SES Space & Defense operates under a proxy board, enabling it to support classified projects, and it has participated in the U.S. Government satcom sector for nearly five decades. Further information can be found at: www.sessd.com.
Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Phase 1 Topline Data Shows Safety and Tolerability. Traws Pharma announced results from its Phase 1 trial testing ratutrelvir, its oral protease inhibitor for COVID-19. The trial was designed to determine pharmacokinetics and safety, with results showing consistent plasma levels within the expected range with no adverse events. A Phase 2a trial is being planned to begin in 1H2025.
Ratutrelvir Could Become A Category-Leading Drug. Ratutrelvir is an inhibitor of the SARS-CoV-2 Main protease (Mpro or 3CL protease). It has demonstrated in vitro activity against the original viral strain and numerous variants, including delta and omicron. Ratutrelvir does not require co-administration of ritonavir as a metabolic inhibitor and avoids the drug-drug interactions and potential side effects. In comparison, Pfizer’s Paxlovid is a combination of its Mpro inhibitor, nirmatrelvir, with ritonavir as a metabolic (cytochrome P450) inhibitor.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
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Exploration at Kuri-Yawi. Aurania is preparing for an induced polarization (IP) geophysical survey of the Kuri-Yawi gold target in Ecuador. The vendor has been selected and the survey is expected to begin in the second half of October. The survey is expected to take approximately one month to complete after which management will review the data to identify targets for a drilling program that we think could commence in the first quarter of 2025. We also believe fieldwork has continued at Crunchy Hill during the quarter.
Anaconda mapping program. Anaconda mapping of the southern and northern parts of Aurania’s Awacha porphyry copper target in Ecuador has been completed. Aurania’s team of geologists is now interpreting the data to define targets for future drilling programs. During the field program, new intrusive outcrops with typical porphyry alteration were discovered.
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.
Key Points: – Oil prices jump 4% as Iran reportedly prepares to strike Israel within hours. – Middle East tensions raise concerns about global oil supply, pushing prices higher. – Investors brace for volatility amid potential disruptions in one of the world’s largest oil-producing regions.
Oil prices surged on Tuesday following warnings from the US that Iran is preparing to launch an attack on Israel within the next 12 hours. This development has significantly heightened concerns over possible disruptions to oil supplies in the Middle East, a region that produces a third of the world’s crude oil.
West Texas Intermediate (WTI) crude saw an immediate increase of nearly 4%, reaching close to $71 a barrel, while Brent crude, the global benchmark, climbed above $74. The potential conflict in this geopolitically critical area may lead to further price hikes if tensions escalate and oil output is impacted. Iran, a member of the Organization of the Petroleum Exporting Countries (OPEC), was the ninth-largest oil producer in 2023, pumping over 3.3 million barrels a day as recently as August.
“The key factor for crude will be whether Israeli defense systems are able to shield against the attack and what subsequent actions Israel might take,” said Rebecca Babin, senior energy trader at CIBC Private Wealth. “In the near term, we could see a few more dollars of short covering in crude.”
This possible disruption marks the most significant threat to oil markets since Russia’s invasion of Ukraine, an event that sent global markets into turmoil last year. Surging oil prices are likely to become a significant concern for consumers and governments, especially in countries like the US where gasoline prices are a political flashpoint. Both major presidential candidates are expected to focus on preventing a further spike in gas prices, with the cost of oil playing a central role in domestic economic debates.
The geopolitical threat comes at a time when oil traders had been betting heavily on bearish market trends, largely driven by concerns of weakening demand growth. The elevated short positions have left the market vulnerable to sharp upward movements if these bearish bets need to be unwound quickly in response to rising tensions in the Middle East.
Concerns about the Middle East have been escalating following the death of Hezbollah leader Hassan Nasrallah last week. In retaliation, Israel has launched airstrikes on Beirut and initiated “targeted ground raids.” As the region braces for further conflict, investors are anticipating potential volatility in the oil market, with Brent crude volatility indices reaching their highest levels since January.
Previously, oil prices had dropped in recent months amid expectations that OPEC+ would increase production just as non-OPEC nations, including the US, ramped up their output. Additionally, China’s weakening demand, as the world’s largest crude importer, has added downward pressure on prices. However, this latest geopolitical flare-up could reverse these trends, injecting fresh instability into global energy markets.
As investors brace for further developments, the oil market remains on edge, with any direct involvement from Iran likely to further disrupt global supplies and drive prices higher.
Ratutrelvir was well-tolerated for 10 days and achieved consistent plasma levels in the predicted therapeutic window, without the need for co-administration of ritonavir
Phase 2a study expected to begin in H1 2025 in patients with COVID
Improving COVID care is an ongoing need, with approximately 50,000 US deaths in 2023
NEWTOWN, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing potential oral small molecule therapies for the treatment of respiratory viral diseases, today announced positive topline Phase 1 results for its potential best-in-class COVID (SARS-CoV-2) candidate, ratutrelvir, an oral inhibitor of the Main protease (Mpro).
“Topline data indicate that administration of ratutrelvir, our product candidate for COVID, as monotherapy, for 10 days to healthy volunteers, showed no treatment related adverse events and demonstrated consistent plasma drug levels in the predicted therapeutic window. We are especially pleased by ratutrelvir’s ability to achieve plasma concentrations that are considerably above the EC90 against a comprehensive panel of SARS-CoV-2 viruses, without the need for ritonavir co-administration that can be a source of drug-drug interactions and potential severe side effects,” said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma. “These data provide us with further indication that ratutrelvir has the potential to be a potent, best-in-class, once-a-day, single-dose, 10-day antiviral therapy for COVID. This profile contrasts with Paxlovid™, an approved Mpro inhibitor, which requires co-administration of ritonavir, a metabolic inhibitor. We believe that ratutrelvir’s ritonavir-free regimen has the potential to reduce the burden of treatment, especially for patients with underlying medical conditions. Based on the Phase 1 data, we have selected the dose for our Phase 2a study, expected to begin in H1 2025.”
“As we near the fifth anniversary of the pandemic, it is notable that, despite the wide availability of approved antiviral therapies, COVID was a major cause of mortality in the US in 2023, with approximately 50,000 deaths1,” said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). “We believe it is important for new COVID therapies to have a simple treatment regimen that can be used broadly, especially in patients who are at higher risk of serious symptoms or who are over 65 years of age with underlying medical conditions including heart disease, kidney disease, and chronic lung disease2. In addition, we consider activity against resistant viruses and low risk of clinical rebound to be important features of potential new COVID therapies. Our enthusiasm for ratutrelvir’s potential to meet the need for improved COVID treatment has been enhanced by the Phase 1 data.”
“Our goal for ratutrelvir is to effectively treat COVID, limit the symptoms of infection, and lower the risk for clinical rebound,” said C. David Pauza, PhD, Chief Scientific Officer for Traws Pharma. “Preclinical studies, presented at the annual International Conference on Antiviral Research in 2024 (ICAR2024), showed that ratutrelvir monotherapy has differentiated activity compared to nirmatrelvir against a range of drug-resistant viruses. Also, preclinical testing in animal models showed that levels of ratutrelvir in the lung were higher than in plasma. Phase 1 data show that ratutrelvir achieved consistent plasma levels in the predicted therapeutic window, with a pharmacokinetic profile that may reduce the likelihood of clinical rebound.”
Topline Phase 1 Results The Phase 1 trial (NCT06402136, conducted in Australia) was designed as a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple ascending doses (SAD and MAD) of ratutrelvir, administered as a capsule formulation in 56 healthy, COVID-negative, adult volunteers, randomized three-to-one (eight subjects per dosing group). The SAD portion of the study evaluated five ratutrelvir dose levels; the MAD segment evaluated two ratutrelvir dose levels, administered once daily for 10 days.
This first-in-human study showed no treatment related adverse events reported up to the highest dose. Topline data also showed that once-daily administration of ratutrelvir maintained plasma drug levels within the predicted therapeutic window. Preclinical studies, presented at the annual International Conference on Antiviral Research in 2024 (ICAR2024), showed that ratutrelvir demonstrated differentiated activity compared to nirmatrelvir against a range of SARS-CoV-2 variants, based on a comparison of EC50 values.
About Ratutrelvir Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity. Ratutrelvir (also previously known as 83-0060 or TRX-01) was designed as an inhibitor of the SARS-CoV-2 Main protease (Mpro or 3CL protease). It has demonstrated in vitro activity against the original strain of the virus as well as the delta and omicron variants, and is more active than nirmatrelvir (Pfizer’s Mpro inhibitor, co-packaged with ritonavir as PAXLOVID™) in preclinical studies. Based on preclinical studies, ratutrelvir did not require co-administration with a metabolic inhibitor, such as ritonavir, which inhibits human cytochrome P450 (CYP) 3A4. Because of this, ratutrelvir is expected to avoid ritonavir-associated drug-drug interactions and potential resulting severe side effects, which may permit wider patient use. The drug candidate’s pharmacokinetic (PK) profile, including the ability to achieve plasma levels within the predicted therapeutic window, as demonstrated in the Phase 1 study, may also enable a once daily treatment regimen and reduce the likelihood of clinical rebound.
About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company developing potential oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes two Phase 1 potentially best-in-class oral small molecules in development: tivoxavir marboxil, a novel oral antiviral drug candidate for influenza and avian flu, targeting the influenza cap-dependent endonuclease, and ratutrelvir, targeting Mpro (3CL protease) for COVID.
In the cancer program, Traws is utilizing a partnering strategy, supported by investigator sponsored studies, to advance two novel proprietary multi-kinase inhibitors, narazaciclib, targeting CDK4+, and rigosertib, targeting cell cycle proteins including PLK-1.
Traws is committed to delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a focus on product safety and a commitment to patients in need or that are specifically vulnerable, we aim to build solutions for important medical challenges and alleviate the burden of viral infections and cancer.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and Traws regulatory plans for ratutrelvir. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, collaborations, merger integration, market conditions and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Earnings Release Scheduled for Thursday, November 7, 2024 Before the Market Opens
Conference Call Scheduled for Thursday, November 7, 2024 at 11:00 AM (Eastern Time)
BOCA RATON, Fla.–(BUSINESS WIRE)–Sep. 30, 2024– The GEO Group, Inc. (NYSE:GEO) (“GEO”) will release its third quarter 2024 financial results on Thursday, November 7, 2024 before the market opens. GEO has scheduled a conference call and simultaneous webcast for 11:00 AM (Eastern Time) on Thursday, November 7, 2024.
Hosting the call for GEO will be George C. Zoley, Executive Chairman of the Board, Brian R. Evans, Chief Executive Officer, Mark Suchinski, Chief Financial Officer, Wayne Calabrese, President and Chief Operating Officer, and James Black, President, GEO Secure Services.
To participate in the teleconference, please contact one of the following numbers 5 minutes prior to the scheduled start time:
In addition, a live audio webcast of the conference call may be accessed on the Webcasts section of GEO’s investor relations home page at investors.geogroup.com. A webcast replay will remain available on the website for one year.
A telephonic replay will also be available through November 14, 2024. The replay numbers are 1-877-344-7529 (U.S.) and 1-412-317-0088 (International). The passcode for the telephonic replay is 7169822. If you have any questions, please contact GEO at 1-866-301-4436.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Client Meetings Answered Questions About Tegoprubart. We held a Virtual Non-Deal Road Show with Eledon’s CEO, Dr. DA Gros. The discussions with clients covered tegoprubart history of development, mechanism of action, clinical trials, and its upcoming milestones. Some of the points raised and common questions are highlighted below.
The Phase 2 BESTOW Trial Completed Enrollment In August. Eledon announced the completion of enrollment for its Phase 2 BESTOW trial that tests tegoprubart against tacrolimus for prevention of kidney transplant rejection. The enrollment was completed ahead of the expected YE2024 timeframe due to higher than expected interest from the transplant surgeons.
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Key Points: – Gogo will acquire Satcom Direct for $375 million in cash and 5 million shares of Gogo stock, expanding its in-flight connectivity solutions. – The combined company will offer multi-band, multi-orbit satellite solutions for business aviation and military/government markets. – The deal is expected to close by the end of 2024, providing cost synergies and significant revenue growth opportunities.
In a significant move to bolster its position in the global in-flight connectivity market, Gogo Inc. (NASDAQ: GOGO) has announced the acquisition of Satcom Direct, a leading provider of geostationary satellite in-flight services for business aviation (BA) and military/government mobility markets. The transaction, valued at $375 million in cash and five million shares of Gogo stock, positions Gogo as the only multi-orbit, multi-band global connectivity provider catering to all segments of the BA market and government mobility sector.
The acquisition, which includes potential earn-out payments of up to $225 million based on future performance, will create significant synergies and accelerate Gogo’s long-term growth. Satcom Direct is expected to generate $485 million in revenue for 2024 with EBITDA margins of approximately 17%. With this acquisition, Gogo aims to expand its total addressable market to the 14,000 business aircraft located outside of North America.
Oakleigh Thorne, Chairman and CEO of Gogo, commented, “This transaction accelerates our growth strategies, expanding our global reach while enabling us to offer integrated satellite solutions. By combining Satcom Direct’s existing capabilities with Gogo’s Galileo LEO (Low Earth Orbit) solution, we can now offer unmatched performance to business aviation and military customers.”
Satcom Direct’s portfolio includes advanced geostationary satellite (GEO) and L-band offerings, which will be integrated into Gogo’s Galileo LEO satellite solutions. This multi-orbit approach will cater to both North American and international customers, providing premium connectivity options for all segments of the business aviation market. The deal also strengthens Gogo’s entry into the military and government mobility vertical, adding new revenue streams and diversifying the company’s customer base.
Chris Moore, President of Satcom Direct, expressed excitement about the acquisition, stating, “We are thrilled to be joining forces with Gogo, which shares our commitment to customer service and innovation. Together, we will unlock opportunities for new technologies, delivering even greater value to our clients worldwide.”
The acquisition not only boosts Gogo’s market presence but also delivers immediate financial benefits. The deal is expected to be accretive to earnings and free cash flow per share from the start, with projected annual run-rate cost synergies of $25-30 million within two years post-closing. Pro forma 2024 revenue for the combined company is expected to reach $890 million, with adjusted EBITDA margins of around 24%.
Looking ahead, Gogo anticipates long-term annual revenue growth of approximately 10%, driven by the combined strengths of its existing customer base and Satcom Direct’s extensive sales and service network. Additionally, the deal opens opportunities for technology upgrades and faster installations, thanks to the combined installed base of over 12,000 aircraft globally.
The transaction, unanimously approved by Gogo’s Board of Directors, is set to close by the end of 2024, pending regulatory approval and customary closing conditions.
Key Points: – The PCE price index showed inflation at 2.2% in August, the lowest since early 2021. – Core PCE, excluding food and energy, rose 2.7%, staying steady with July’s reading. – The lower-than-expected inflation could prompt additional interest rate cuts by the Fed.
The Federal Reserve’s key inflation measure, the Personal Consumption Expenditures (PCE) price index, posted a notable drop to 2.2% in August, marking the lowest inflation rate since February 2021. This is a clear signal that inflation is continuing its downward trend, positioning the Fed for future interest rate cuts.
The PCE index, which measures the cost of goods and services in the U.S. economy, saw just a 0.1% increase in August from the previous month. Economists had expected the year-over-year inflation rate to settle at 2.3%, but the actual figure came in even lower, underscoring a continued easing of inflation pressures. This development further supports the Fed’s pivot toward focusing on labor market support, rather than aggressive inflation-fighting measures.
The core PCE index, which excludes the volatile food and energy prices, rose by 0.1% in August and maintained an annual increase of 2.7%, in line with economists’ expectations. This core measure is a preferred gauge for the Fed when assessing long-term inflation trends. The steady core inflation number is likely to reinforce the Fed’s decision-making, signaling that while inflation is cooling, there are still pressures, especially in key sectors such as housing.
The recent PCE numbers are particularly crucial as they come on the heels of the Fed’s decision to cut its benchmark interest rate by half a percentage point, lowering it to a target range of 4.75%-5%. It was the first time since March 2020 that the Fed made such a significant rate cut, deviating from its typical quarter-point moves.
With inflation easing closer to the Fed’s long-term 2% target, the latest data could pave the way for additional interest rate reductions by the end of the year. Many market participants expect the Fed to make another cut by half a percentage point before the year’s end, followed by further reductions in 2025.
Fed officials have gradually shifted their focus from solely managing inflation to also supporting the U.S. labor market. Recent data has indicated some softening in the job market, with Fed policymakers noting the need to balance between maintaining price stability and ensuring continued employment growth.
Chris Larkin, managing director of trading and investing at E-Trade from Morgan Stanley, commented on the positive inflation news, saying, “Inflation continues to keep its head down, and while economic growth may be slowing, there’s no indication it’s falling off a cliff.”
Despite the positive inflation report, personal income and spending data were weaker than expected. Personal income increased by 0.2%, while spending also rose by 0.2% in August. Both figures fell short of their respective forecasts of 0.4% and 0.3%. These softer numbers suggest that while inflation may be cooling, consumer demand remains fragile, posing potential risks to broader economic growth.
Looking ahead, investors and market watchers will be closely monitoring upcoming U.S. data, including personal consumption expenditures and jobless claims, for further clues about the Fed’s next move.
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 Neurol2018;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.
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.
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