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Time of India
13-05-2025
- Business
- Time of India
Tariff uncertainty clouds outlook for US television's annual ad-selling bonanza
HighlightsThe annual upfront selling season for the television industry is overshadowed by concerns regarding U.S. President Donald Trump's tariff policies, which may lead to a recession and affect advertising spending. Research firm eMarketer predicts that traditional television ad spending during the upfronts could drop to $13.4 billion, a decline of $4 billion from last year, depending on the impact of tariffs. Despite economic uncertainty, some media companies like The Walt Disney Company and Netflix remain optimistic about advertising growth, with Netflix expecting to double its ad revenue this year. The risk of a tariff-induced U.S. recession is hanging over the television industry's annual upfront selling season, when companies stage star-studded pitches to coax brands to commit to spending billions of dollars on advertising in the year ahead. Starting Monday, the presentations in New York kick off weeks of negotiations in which television networks and streaming services typically lock in the largest share of their ad revenue for the year. YouTube promises a performance by Lady Gaga and an appearance from one of its biggest stars, Mr. Beast. NBCUniversal will host its presentation at Radio City Music Hall and Warner Bros. Discovery at Madison Square Garden. But the champagne-fueled parties will take place against a backdrop of economic concerns, stemming from U.S. President Donald Trump's on-again, off-again tariff policies, which economists warn may lead to a recession. While major media companies have not reported any decline in ad demand, industry analysts predict brands will reduce their spending as consumer confidence wanes. Research firm eMarketer projects ad spending on traditional television during the upfronts could fall to $13.4 billion, down $4 billion from last year, depending on the level of tariffs that take effect. The Trump administration is negotiating deals with a number of major trading partners, including China. For digital ads on online devices, the worst-case scenario is that spending will stay flat at around $13 billion, eMarketer said. If tariffs are limited, digital ads could rise to $14.7 billion. Data firm Guideline said a pullback was already evident. Ad spending rose 7 per cent in the first quarter compared to the same period in 2024, but future bookings suggest growth could decelerate to 3 per cent in the second quarter, Guideline said. Media executives acknowledged some brands might feel nervous, but said there could be a cost to cutting ad spending. "Clients learned some important lessons during COVID, when a lot of advertisers pulled back very quickly and then had to redeploy those funds," said Jeff Collins, president of advertising sales, marketing and brand partnerships at Fox. "And I think that they're trying not to have a knee-jerk reaction to what is happening now." Advertisers that wait to purchase time at the last minute in the so-called "scatter" market sometimes pay double-digit percentage increases in rates, Collins said. Fox had not yet seen any impact on ad demand from tariffs, he added. Karen Kovacs, president of advertising sales and partnerships at NBCUniversal, said brands that continued to spend on advertising during past downturns maintained better sales and market share than others that cut back. NBCU parent Comcast, in its latest earnings report, said ad revenue was roughly flat during the first three months of 2025. BUYER'S MARKET Sellers of ad time may need to give concessions on pricing and cancellation terms to win business, said eMarketer senior analyst Ross Benes, adding tariffs would have most impact on the advertising of physical products like cars and consumer goods. Digital players like Google's YouTube or Facebook parent Meta will likely emphasize the use of artificial intelligence to help brands reach customers more efficiently, said Greg Kahn, CEO of GK Digital Ventures media advisory firm. Many U.S. companies have cut or withdrawn their annual forecasts, citing an uncertain trade environment, including General Motors, Kraft Heinz and bleach maker Clorox. Clorox is evaluating how much it spends on advertising, CEO Linda Rendle said on an earnings call last week. "We're going to continue to invest strongly in our brands, but at what level makes the most amount of sense given the returns that we're getting," Rendle said. Still, some media firms remain upbeat. Disney expects annual advertising growth to surpass its previous 3 per cent forecast, while Netflix co-CEO Greg Peters said in April the company was not seeing any signs of softness in its pre-upfronts discussions. The company does not disclose ad revenue, but analysts polled by LSEG project Netflix will bring in $2.7 billion from advertising in 2025. Netflix launched its ad-supported options in November 2022 and is still in the early stages of building that business. "That smallness probably provides us some insulation to market shifts right now," Peters said, adding that Netflix expects to double ad revenue this year.
Yahoo
12-05-2025
- Business
- Yahoo
Tariff uncertainty clouds outlook for US television's annual ad-selling bonanza
By Lisa Richwine and Dawn Chmielewski LOS ANGELES (Reuters) -The risk of a tariff-induced U.S. recession is hanging over the television industry's annual upfront selling season, when companies stage star-studded pitches to coax brands to commit to spending billions of dollars on advertising in the year ahead. Starting Monday, the presentations in New York kick off weeks of negotiations in which television networks and streaming services typically lock in the largest share of their ad revenue for the year. YouTube promises a performance by Lady Gaga and an appearance from one of its biggest stars, Mr. Beast. NBCUniversal will host its presentation at Radio City Music Hall and Warner Bros. Discovery at Madison Square Garden. But the champagne-fueled parties will take place against a backdrop of economic concerns, stemming from U.S. President Donald Trump's on-again, off-again tariff policies, which economists warn may lead to a recession. While major media companies have not reported any decline in ad demand, industry analysts predict brands will reduce their spending as consumer confidence wanes. Research firm eMarketer projects ad spending on traditional television during the upfronts could fall to $13.4 billion, down $4 billion from last year, depending on the level of tariffs that take effect. The Trump administration is negotiating deals with a number of major trading partners, including China. For digital ads on online devices, the worst-case scenario is that spending will stay flat at around $13 billion, eMarketer said. If tariffs are limited, digital ads could rise to $14.7 billion. Data firm Guideline said a pullback was already evident. Ad spending rose 7% in the first quarter compared to the same period in 2024, but future bookings suggest growth could decelerate to 3% in the second quarter, Guideline said. Media executives acknowledged some brands might feel nervous, but said there could be a cost to cutting ad spending. "Clients learned some important lessons during COVID, when a lot of advertisers pulled back very quickly and then had to redeploy those funds," said Jeff Collins, president of advertising sales, marketing and brand partnerships at Fox. "And I think that they're trying not to have a knee-jerk reaction to what is happening now." Advertisers that wait to purchase time at the last minute in the so-called "scatter" market sometimes pay double-digit percentage increases in rates, Collins said. Fox had not yet seen any impact on ad demand from tariffs, he added. Karen Kovacs, president of advertising sales and partnerships at NBCUniversal, said brands that continued to spend on advertising during past downturns maintained better sales and market share than others that cut back. NBCU parent Comcast, in its latest earnings report, said ad revenue was roughly flat during the first three months of 2025. BUYER'S MARKET Sellers of ad time may need to give concessions on pricing and cancellation terms to win business, said eMarketer senior analyst Ross Benes, adding tariffs would have most impact on the advertising of physical products like cars and consumer goods. Digital players like Google's YouTube or Facebook parent Meta will likely emphasize the use of artificial intelligence to help brands reach customers more efficiently, said Greg Kahn, CEO of GK Digital Ventures media advisory firm. Many U.S. companies have cut or withdrawn their annual forecasts, citing an uncertain trade environment, including General Motors, Kraft Heinz and bleach maker Clorox. Clorox is evaluating how much it spends on advertising, CEO Linda Rendle said on an earnings call last week. "We're going to continue to invest strongly in our brands, but at what level makes the most amount of sense given the returns that we're getting," Rendle said. Still, some media firms remain upbeat. Disney expects annual advertising growth to surpass its previous 3% forecast, while Netflix co-CEO Greg Peters said in April the company was not seeing any signs of softness in its pre-upfronts discussions. The company does not disclose ad revenue, but analysts polled by LSEG project Netflix will bring in $2.7 billion from advertising in 2025. Netflix launched its ad-supported options in November 2022 and is still in the early stages of building that business. "That smallness probably provides us some insulation to market shifts right now," Peters said, adding that Netflix expects to double ad revenue this year. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Mid East Info
06-05-2025
- Business
- Mid East Info
Dubai Electronic Security Center Launches New Innovative Projects at GISEC Global 2025 - Middle East Business News and Information
Launched the 'Zero Trust' guideline to secure government networks and the advanced 'Ethaq Plus' for safeguarding digital transactions. Rolled out a certification program for Information Security Officers to equip individuals across various government sectors with the skills needed to implement the information security regulations Introduced a Post-Quantum Cryptography (PQC) Guideline to bolster Dubai's digital infrastructure readiness. Al Shaibani: 'These new projects reflect our commitment to building a reliable and sustainable digital infrastructure that aligns with Dubai's vision of becoming the world's smartest and safest city.' Dubai, UAE, May 2025: The Dubai Electronic Security Center announced the launch of a series of innovative initiatives and projects aimed at strengthening the emirate's digital security and cyber infrastructure, while also advancing specialized talent development in the sector. The announcements were made during the Gulf Information Security Expo and Conference (GISEC Global 2025), held at the Dubai World Trade Centre from May 6-8, where the Center is participating as the official Government Cybersecurity Partner. Zero Trust Assessment Tool and Guideline: Among the new initiatives is the Zero Trust Assessment Tool and Guideline, a major leap in securing Dubai's government networks and includes a comprehensive guide for implementing the Zero Trust model, which emphasizes continuous verification of identity and access rights. This practical tool assists organizations and local entities in transitioning to a Zero Trust framework, ensuring the protection of critical systems and data, in complex and dynamic technological environments, thereby reducing the risk of breaches and insider threats. The guideline will be implemented across several government entities in Dubai using advanced technologies, including multi-factor authentication, network segmentation, continuous digital traffic monitoring, and data classification based on sensitivity levels. These measures minimize cyberattack exposure and ensure swift response to breach attempts, despite challenges such as integrating the new system with existing infrastructure and maintaining a seamless user experience. ETHAQ Plus Initiative: The Dubai Electronic Security Center also launched the advanced 'Ethaq Plus' initiative, aimed at elevating digital trust and enabling secure, reliable transactions for organizations. The service provides certified digital certificates to protect data and communications, verify authenticity, and support the adoption of trusted digital identities and advanced security models that reduce cyber risks at the institutional level. Information Security Officers Certification Program: As part of its efforts to develop national talent, the Center introduced the ISR Officer Certification Program to equip individuals across various government sectors with the knowledge and skills needed to implement the information security regulations effectively. It also helps cultivate a new generation of cybersecurity officers, strengthening the resilience and sustainability of Dubai's government operations. Readiness for Quantum Technologies: In preparation for future threats arising from advancements in quantum computing, DESC launched the Post-Quantum Cryptography Guideline. This guide is designed to prepare Dubai's digital infrastructure to counter emerging quantum-based threats. The initiative marks a strategic step to ensure Dubai's digital defenses remain at the forefront, safeguarding the city's smart data, services, and thriving digital future. H.E. Yousuf Hamad Al Shaibani, Chief Executive of the Dubai Electronic Security Center, said: 'At the Dubai Electronic Security Center, we are committed to fostering a resilient and secure cyber environment driven by innovation and proactive adaptability to evolving challenges. The new projects we unveiled at GISEC Global 2025 reflect our vision to build a trusted, sustainable digital infrastructure aligned with Dubai's future goal of becoming the smartest and safest city in the world.' Al Shaibani added, 'By adopting concepts like Zero Trust and developing advanced national platforms, we reaffirm our commitment to providing strategic solutions that support government and private entities in protecting their critical data and services, enabling them to accelerate digital transformation with confidence and efficiency. We also believe that investing in national talent is the cornerstone of cultivating a new generation of cybersecurity leaders capable of ensuring the sustainability of Dubai's digital security.' Specialized Cybersecurity Challenges: During the event, the Center launched the latest edition of the Dubai Cyber Challenge, dedicated to Dubai government entities. The challenge aims to assess and enhance participants' cybersecurity skills while promoting compliance with the Center's Information Security Regulations (ISR). The competition features over 30 carefully designed tasks simulating commonly used government applications and services in Dubai. With varying difficulty levels, the challenges allow participants to test their cybersecurity abilities across diverse scenarios. Additionally, DESC is hosting the School of Cyber Defense Championship in partnership with TechFirm, attracting over 300 applications from university students across the UAE. Participants compete in an advanced environment simulating real-world cybersecurity challenges, where they respond to cyberattacks and identify security vulnerabilities. Winners will receive valuable prizes worth over AED 130,000, supporting the development of their skills and careers in the cybersecurity field.
New York Times
05-05-2025
- Entertainment
- New York Times
Is This Late-Night TV's Last Gasp?
John Mulaney describes his weekly Netflix talk show as 'a throwback in some ways.' Indeed, it seems to draw inspiration from numerous 20th-century late-night hosts, from Dick Cavett to David Letterman to Conan O'Brien. 'It's almost like the way you might remember a bunch of shows from the past, but it's not exactly what they were like,' Mr. Mulaney said in an interview from his sun-soaked office in Hollywood. He was between meetings, gearing up for the latest episode of his show, 'Everybody's Live,' which appears Wednesdays at 10 p.m. Eastern. 'No element is new,' he added, 'but the way they're being laid out might feel a little bit.' Mr. Mulaney's show represents an important test in the entertainment industry: Can the traditional talk show format — with an opening monologue, celebrity guests, live musical performances, a sidekick — survive in the streaming era? Or is the future of talk shows something quite different, and much more like … podcasts? As the television industry has leaped to streaming, many old genres have come along. Prestige dramas, crime documentaries, reality TV, stand-up specials and even soap operas have successfully crossed over. But not talk shows. Even on traditional network and cable TV, ratings for late-night talk shows are down, and advertising revenue has plummeted. The number of shows is falling, too, so much so that last year's Emmy Awards had one nominee fewer because of a lack of submissions. This fall, CBS will forgo programming its 12:30 a.m. slot, the first time in three decades that the network will not have an original talk show in that wee hour. 'Of all the legacy broadcast day parts — morning shows, evening news, late night — late night might be the first one headed for the wood chipper,' said Jim Bell, a former showrunner of 'The Tonight Show' on NBC and now a senior executive for the 2028 Summer Olympics in Los Angeles. 'It's expensive to make, tough to monetize and no longer appointment viewing. It's still got cultural juice, but from a business standpoint, it's the most vulnerable.' As recently as 2018, the five broadcast network late-night shows — hosted by Stephen Colbert, Jimmy Fallon, Jimmy Kimmel, James Corden and Seth Meyers — drew an estimated $439 million in combined advertising revenue, according to Guideline, an advertising data firm. By 2022, that figure had fallen to $277 million, Guideline said. Last year, it plunged to $220.6 million, nearly a 50 percent decline from 2018. Late-night hosts remain big-time celebrities, however, something that complicates the equation for media executives. 'The hosts still matter,' Mr. Bell said. Other kinds of talk shows are doing perfectly well. 'Hot Ones,' a digital celebrity interview series conducted over spicy chicken wings, is a bona fide hit, and a bidding war for its streaming rights is expected this year. Jon Stewart's once-a-week return to 'The Daily Show' last year has been a boon for Comedy Central, minting viral moments and driving higher ratings. Additionally, many podcasts film their shows and find large audiences on YouTube. In fact, YouTube has surpassed Spotify and Apple as the top platform for podcasts, according to several studies. Since last year, podcast stars have signed the sort of media megadeals that used to be reserved for late-night hosts, celebrity news anchors, big producers or the cast of 'Friends.' Those deals include Joe Rogan (reportedly $250 million), Alex Cooper ($125 million), the three hosts of 'SmartLess' ($100 million) and the brothers Jason and Travis Kelce (another $100 million). Mr. O'Brien quietly left late night four years ago but has had a career renaissance — including what will be back-to-back hosting gigs at the Oscars — thanks to his podcast, 'Conan O'Brien Needs a Friend.' (A wildly popular appearance on 'Hot Ones' last year did not hurt, either). 'The lines between podcasts and talk shows are getting pretty blurry,' Ted Sarandos, co-chief executive of Netflix, mused during a recent earnings call. So much so that he added, 'As the popularity of video podcasts grow, I suspect you will see some of them find their way to Netflix.' Before Mr. Mulaney's show, which premiered in March, Netflix appeared to have gotten out of the traditional talk show format altogether. Star comedians like Chelsea Handler, Norm Macdonald, Joel McHale and Michelle Wolf all hosted talk shows on Netflix that came and went in the late 2010s. Sarah Silverman's show on Hulu was canceled after two seasons, and even Mr. Stewart had a show (for Apple TV+) that had difficulty gaining traction. Part of the problem could be that a format that worked for a long time in traditional television may not work in a new medium. 'On digital platforms, like YouTube or a TikTok, talent is connecting with an audience just like how talent would connect with an audience on linear television — but the way you're doing it is very different,' said Chris Licht, a former executive producer of 'The Late Show' on CBS and a former chairman of CNN. 'So the format has to adjust.' Mr. Mulaney, a renowned stand-up comedian and comedy writer, wound up hosting a talk show almost by accident. During the Netflix Is a Joke comedy festival last May, he was assigned to produce a nightly live show, one that could host the many comedic legends in Los Angeles during the event. Mr. Mulaney originally envisioned a show that would be a bit 'like MTV,' he said, where the host would serve as a sort of V.J., introducing one comic and then the next. He decided he could host it himself, and before long, the concept started to morph into the show's current iteration. 'Then it became like, well, people can come out and I'll talk to them, and then they'll sit there,' Mr. Mulaney said. 'Then I'm interviewing people, and we're doing bits. Like, we couldn't have backed into it in a more convoluted way.' Robbie Praw, Netflix's vice president of stand-up and comedy formats, said in an interview that the company had not initially been 'looking or aspiring to do another talk show.' It was more interested 'in being in the John Mulaney business' than in talk shows generally, he said, adding, 'John is so singular.' The first season of the show, called 'Everybody's in LA,' ran for all of six episodes but was a huge critical hit. Netflix went ahead and ordered 12 episodes for this year and changed the name to 'Everybody's Live.' There has been no shortage of big-name guests. Mr. Letterman, Mr. O'Brien, Tina Fey, Bill Hader and Ben Stiller, among other comedic superstars, have appeared this season. And though the show loosely follows one theme (planning a funeral, borrowing money, getting fired), Mr. Mulaney is not following in the footsteps of Mr. Colbert or John Oliver and dedicating much of the show to the current political news cycle. 'I was kind of like, what type of show do I want to watch?' Mr. Mulaney said. 'And it is not — because the ground is well covered by great people — a topical 'Can you believe sociopolitical story of the day?'' The performance of 'Everybody's Live' could be a key piece of evidence to determine whether streaming executives will keep taking a stab at the format or stop altogether. Mr. Mulaney strongly suggested that he would be interested in doing another season. It is not clear how the show is performing, but critical attention has been more muted this season. The first episode appeared in Netflix's daily 10 most-watched TV series in the United States, but the show has not returned in the subsequent seven weeks. Mr. Praw, the Netflix executive, said he was 'extremely, extremely excited about the creative direction of the show.' He pointed to one comedic bit in April — roughly two dozen men standing onstage side by side, ranging from five to seven feet tall — while Mr. Letterman looked on as a guest. 'I had goose bumps in that moment because it had echoes of everything I used to love about David Letterman,' Mr. Praw said. 'And there sat David Letterman on the couch during that. What a special moment' He said Netflix was not prepared, however, to announce anything yet about a potential third season. 'Every show we've ever done we want more people to watch,' he said.
Yahoo
18-03-2025
- Business
- Yahoo
RedHill Biopharma to Submit FDA-Approved Talicia® for UK Marketing Authorisation
RedHill plans to submit UK MAA1 for Talicia for H. pylori infection, using MHRA's2 new fast-track approval process, referencing FDA approval, with potential UK approval in Q4/25 Listed by ACG3 Clinical Guideline as a first-line option, Talicia is the leading branded H. pylori therapy prescribed by U.S. gastroenterologists and the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori resistance to other antibiotics Talicia is also approved and launched in the UAE4 and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes H. pylori infection is a billion-dollar market opportunity affecting approximately 40% of the UK adult population,5 a third of the U.S. adult population and over 50% of the global adult population6 RALEIGH, N.C., March 18, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced its plan to submit a UK Marketing Authorisation Application (MAA) for Talicia for treatment of helicobacter pylori (H. pylori) infection under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP), a fast-track regulatory process for UK drug approvals based on a recognized reference approval. Utilizing the U.S. Food and Drug Administration (FDA) approval of Talicia as reference, potential UK approval could be received as early as the fourth quarter of 2025. Talicia, the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori resistance to other antibiotics commonly used in H. pylori therapies, is listed in the American College of Gastroenterology (ACG) Guideline as a first-line treatment option and is the number one branded H. pylori therapy prescribed by U.S. gastroenterologists. Some additional countries may accept UK MHRA approvals as a reference for their own approval processes which could expedite ongoing discussions with prospective territorial commercialization partners for Talicia. H. pylori infection affects approximately 35% of the U.S. adult population and over 50% of the global adult population7. It is classified, by the World Health Organization (WHO), as a Group 1 carcinogen and the strongest known risk factor for gastric cancer (causing between 70% to 90% of cases) and a major risk factor for peptic ulcer disease (causing 90% of cases)8. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "The American College of Gastroenterology (ACG) Guideline specifically recommends against the use of clarithromycin as part of any H. pylori treatment regimen without prior susceptibility testing. Resistance to both clarithromycin and levofloxacin, estimated at up to 40%, has been rising significantly and is linked to high H. pylori treatment failure rates – with more than one in three patients failing on standard proton pump inhibitor-clarithromycin triple therapy when used in the face of known clarithromycin resistance9. Talicia is now the leading prescribed branded H. pylori therapy by U.S. gastroenterologists, with the ACG Guideline listing it as first-line treatment option for H. pylori infection, based on Talicia's proven superior efficacy – up to 90% effective - and safety, zero to minimal rifabutin resistance, and its convenient FDA-approved three-times daily (TID) 'breakfast, lunch, and dinner' dosing, providing for easier adherence.10,11,12 Almost 40% of the UK population are infected by H. pylori13, 14 and 18 people are diagnosed with gastric cancer in the UK every day15, despite confirmed eradication of H. pylori infection leading to a 75% decreased risk of gastric cancer.16 We are committed to expanding the global access and sales of Talicia following approvals in the U.S. and UAE4, and planned UK submission, and we are exploring opportunities with potential commercialization partners in this global predicted billion-dollar market." About Talicia Approved by the FDA for the treatment of H. pylori infection in adults in November 2019, Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). Talicia has received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide. Talicia is also approved by the United Arab Emirates (UAE) Ministry of Health and was launched there by Ghassan Aboud Group (GAG) in August 2024. About RedHill Biopharma RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults17. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program study in prostate cancer in combination with Bayer's darolutamide; (ii) RHB-204 with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (v) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential submission of Talicia® for UK Marketing Authorisation and any approval thereof and statements regarding the potential effects of Talicia® in the treatment of Helicobacter pylori infection. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that the Company may not submit a UK MAA for Talicia and if it does that submission may not be successful; the risk that the development of RHB-204 for Crohn's disease may not be completed and if completed may not be successful; the risk that the Company will not benefit from its agreement with Hyloris as currently anticipated; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company Contact: Adi FrishChief Corporate & Business Development OfficerRedHill Biopharma+972-54-6543-112adi@ Category: R&D [1] MAA refers to Marketing Authorisation Application[2] MHRA refers to Medicines and Healthcare products Regulatory Authority[3] ACG refers to American College of Gastroenterologists[4] UAE refers to United Arab Emirates[5] [6] Hooi JKY, et al. Global Prevalence of Helicobacter Pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017;153(2):420–429.[7] Hooi JKY, et al. Global Prevalence of Helicobacter Pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017;153(2):420–429.[8] Chey et al. Am J Gastroenterol. 2024[10] Resistance rates as determined by in vitro testing of 345 H. pylori isolates collected at baseline from patients enrolled in the Talicia pivotal trial[11] Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.[12] The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).[13] [14] Hooi JKY, et al. Global Prevalence of Helicobacter Pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017;153(2):420–429.[15] [16] Kumar S, et al. Risk Factors and Incidence of Gastric Cancer After Detection of Helicobacter pylori Infection: A Large Cohort Study. Gastroenterology. 2020;158(3)[17] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: Logo: View original content: SOURCE RedHill Biopharma Ltd.
