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PHILADELPHIA and VANCOUVER, British Columbia, Dec. 11, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, today announced that it intends to offer to sell common shares and warrants in an underwritten public offering. All of the common shares and warrants are to be sold by the Company. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. ThinkEquity is acting as the sole book-running manager for the offering. The Company intends to use the net proceeds from the offering primarily for working capital requirements, general corporate purposes, and the advancement of business objectives. The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on January 22, 2024 and declared effective on January 31, 2024. The offering will be made only by means of a written prospectus. A preliminary prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41 st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/ . Forward-Looking Statements This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those related to our ability to close the underwritten public offering and the use of proceeds, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risk Factors” in the Company’s most recent annual report, and in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company’s profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release. Company Contact: William V. Williams, MD President & CEO 1-888-485-6340 info@briacell.com Media Relations: Jules Abraham CORE IR julesa@coreir.com Investor Relations Contact: CORE IR investors@briacell.comThe last mayor to go through three police commissioners in a single term quit in the middle of that term, before the governor could fire him or prosecutors could charge him for all the “beneficences” he’d pocketed.
Regions Financial Co. (NYSE:RF) Shares Sold by Larson Financial Group LLC
'Emerging' B.C. family cooks up something special in the frozen meals business
DYK Hrithik Roshan jumped on Shah Rukh Khan, Salman Khan's car bonnet on Karan Arjun sets? Here's what happenedIn an effort to curb unnecessary roadside crashes and deaths, the Auto Club Group has partnered with Waze GPS to report their roadside assistance calls to drivers on the road. According to AAA, the group responds to more than 30 million calls for roadside assistance across the country, which is one call every two seconds. Additionally, their research shows that two emergency responders are killed every month. “Far too many deaths occur because drivers are either not paying attention or do not realize they’re approaching someone on the roadside,” said Scott VerBracken, vice president of automotive services for AAA. With the new sharing of AAA data, drivers who use Waze or Google Maps for navigation in select states will receive an alert when they approach a AAA member and/or a AAA technician on the roadside, allowing motorists to slow down or move over as they approach the scene. The Auto Club Group says that the apps will notify drivers when a AAA member has car trouble and requests roadside assistance. The app’s technology will pinpoint the location within Waze or Google Maps, and approaching drivers will receive an alert. When a roadside technician arrives on location, the alert will automatically update to warn approaching drivers that an ACG service technician is ahead. “We are excited about this technological advancement and believe it will give drivers the warning they need to move over and save the lives of our members and employees,” said VerBracken. This GPS mapping enhancement is now active in 14 states, including Colorado, Florida, Georgia, Illinois, Iowa, Michigan, Nebraska, North Carolina, North Dakota, South Carolina, Tennessee, Wisconsin and parts of Indiana and Minnesota.PEOPLE are just realising energy firms are giving out free gadgets to keep you warm this winter. The temperature has well and truly dropped this week and many households will be cranking up their heating, leading to a likely hike in energy bills. But billpayers may not know that they could qualify for a number of energy-saving freebies. Octopus Energy is offering customers free electric blankets t hrough its £30million Octopus Assist fund . Ovo Energy is also offering money-saving gadgets to households through a £50million customer support package . Customers struggling to pay bills can get access to free energy-saving items like heated throws and mattress toppers. READ MORE ON ENERGY One customer took to social media to share how they received a heated throw from Ovo. Writing in the Extreme Couponing and Bargains UK Facebook group, they said: "Just wanted to say thank you to the lady who posted about free heated throw from OVO. "Mine arrived yesterday. I didn't know anything about this offer until I read it here." Others rushed to comments to say they didn't know about the scheme. Most read in Money One asked if the offer was available if you're on a pay-as-you-go meter to which a fellow customer assured her it was. Another said: "Just found it and applied thank you I was planning on trying to buy one." A third wrote: "Just found it and applied thank you I was planning on trying to buy one." While a fourth said: "I applied when I read about it here. Arrived last week and it's been wonderful. Been using my electric throw every day and am so much warmer now." And a fifth commented: "I'm with Ovo I didn't know!" "Me too, I have applied, thank you," another posted. You can apply for OVO's Customer Support Package on its website. The firm said applications should take around two minutes but you should have some information ready to hand, including: Your monthly disposable income (this is any income after you’ve paid tax , rent or mortgage payments, and essentials like utility bills ) Your account number and postcode You may also have to include how many people live in your home, what your main type of heating is and how you pay for your energy. You may also have to state whether you have qualified for the Warm Home Discount before or are on means-tested benefits . You can make applications on behalf of yourself and others, for example, a family member who doesn't have access to the internet . Others commented that Octopus Energy offers a similar deal. One wrote: "Octopus Energy do this as well as a £136 holiday payment charged to your account. On low income don’t have to be receiving benefits just need to meet the criteria of your outgoings." A second posted: "Octopus do one too if anyone is with them." Octopus Energy is offering customers free electric blankets t hrough its £30million Octopus Assist fund . The energy firm, which services almost seven million households, is dishing out the money-saving gadgets to the most vulnerable. This means those most likely to receive help are the elderly and those with mobility issues or other medical conditions. You should contact Octopus to find out if you're eligible for help. What other freebies can I get? Thousands of households on benefits can get help applying for free and cheap boilers through the Energy Company Obligation (ECO) . Help is offered on a case-by-case basis, but it can mean having a new boiler fitted, or loft or cavity wall insulation put in, often for free. A number of energy companies are signed up to the scheme, including British Gas and EDF. Several energy firms have grant schemes available to customers struggling to cover their bills. But eligibility criteria vary depending on the supplier and the amount you can get depends on your financial circumstances. For example, British Gas customers struggling to pay their energy bills can get grants worth up to £2,000. READ MORE SUN STORIES E.ON, Octopus and Scottish Power all have their own schemes where you can get money towards the cost of bills too. It's worth speaking to your supplier to see what help is at hand. SWITCHING energy providers can sound like a hassle - but fortunately it's pretty straight forward to change supplier - and save lots of cash. Shop around - If you're on an SVT deal you are likely throwing away up to £250 a year. Use a comparion site such as MoneySuperMarket.com, uSwitch or EnergyHelpline.com to see what deals are available to you. The cheapest deals are usually found online and are fixed deals - meaning you'll pay a fixed amount usually for 12 months. Switch - When you've found one, all you have to do is contact the new supplier. It helps to have the following information - which you can find on your bill - to hand to give the new supplier. Your postcode Name of your existing supplier Name of your existing deal and how much you payAn up-to-date meter reading It will then notify your current supplier and begin the switch. It should take no longer than three weeks to complete the switch and your supply won't be interrupted in that time. Do you have a money problem that needs sorting? Get in touch by emailing money-sm@news.co.uk . Plus, you can join our Sun Money Chats and Tips Facebook group to share your tips and stories
The U.S. is by far Superior Glove Work’s biggest market, with 70 per cent of the work and safety gloves it makes destined for south of the border. Carlos Osorio/The Globe and Mail Weeks before his return to the White House, Donald Trump is already sending shockwaves through the Canadian business community. The U.S. president-elect promised this week to impose 25-per-cent tariffs on imports from Canada and Mexico over border security concerns – a plan that many executives and economists are skeptical will become reality. Even so, companies are preparing for a tumultuous four years under Mr. Trump , given the trade skirmishes that defined his first term in office. Small and mid-sized manufacturers are especially vulnerable to steep tariffs because many of them have become tightly integrated with the U.S. market over three decades of free trade. The Globe and Mail spoke with five executives about how they’re strategizing for Trump 2.0. Superior Glove has spent the past year building its first American manufacturing facility in North Carolina. Gloves produced in that facility can bypass any potential tariffs and sell directly into the U.S. market. Carlos Osorio/The Globe and Mail Superior Glove Works When Tony Geng first heard Mr. Trump’s tariff plan, the owner of Superior Glove Works Ltd. flashed back to 2017 and the early days of the first Trump administration. Back then, during the renegotiation of the North American free-trade agreement into what is now known as the U.S.-Mexico-Canada Agreement, the Americans wanted the removal of certain provisions related to textiles and apparel. “In the end, what was needed was kept in, but not before a whole lot of worrying and sleepless nights while those negotiations were going on,” Mr. Geng said in an interview. “This new announcement has a very similar taste to what happened back then and it brings back the same worries until it is settled.” Acton, Ont.-based Superior Glove has three production facilities in Canada – one at its headquarters and two in Newfoundland – that collectively employ about 450 people. The U.S. is by far the company’s biggest market, with 70 per cent of the work and safety gloves it makes destined for south of the border. “Being a Canadian company, we want to make as much as we possibly can in Canada, even if it costs us, say, 15- or 20-per-cent more to provide in Canada, but add a 25-per-cent tariff and it is going to become pretty hard to do anything in Canada,” Mr. Geng said. One key difference between 2017 and today is that Superior Glove has spent the past year building its first American manufacturing facility in North Carolina. Gloves produced in that facility, with operations set to begin in the spring of 2025, can bypass any potential tariffs and sell directly into the U.S. market. “We thought we should do something to mitigate the protectionist threat,” Mr. Geng said, “but when we started that plan, it was just out of the recognition that the U.S. is our biggest market so we really should have some manufacturing presence there.” However, the plan for the U.S. facility was to produce new products while existing products continued to come from Canada and two other plants Superior owns in Honduras. The North Carolina facility was never intended to replace any Canadian production and Mr. Geng said Superior Glove would not be able to shift enough production there to offset the impact of any potential tariffs. Acton, Ont.-based Superior Glove has three production facilities in Canada – one at its headquarters and two in Newfoundland – that collectively employ about 450 people. Carlos Osorio/The Globe and Mail “In hindsight I am extra glad we started this plan over a year ago so we aren’t totally behind the eight-ball, though it really does seem like the end result of this, if it were to happen, is to drive business to China rather than more business and manufacturing jobs to the States,” he said. China already produces the vast majority of the world’s gloves and Mr. Geng said producers there would be best positioned to absorb the cost of any tariffs because of their low cost of labour and materials. That would be an ironic outcome given China is the primary target of Mr. Trump’s tariff plans. Superior also buys most of its raw materials, such as cotton and polyester, from the U.S., but Mr. Geng said “if the gloves end up being made in China instead, the Chinese aren’t going to buy cotton from the States or polyester from the States. It would just be an even bigger net loss for the United States, so these tariffs just really don’t seem like a great plan.” -Jameson Berkow Kacee Vasudeva, owner of auto parts plant Ultra-Form Manufacturing Ltd., is negotiating a $2-million sale to a U.S. customer. Christopher Katsarov/The Globe and Mail Ultra-Form Manufacturing From his low-slung factory in the northwest corner of Toronto, Kacee Vasudeva competes with auto-parts makers in Mexico, China and Europe. The Trump tariff would make this a lot harder. Mr. Vasudeva’s company, Ultra-Form Manufacturing, turns chunks of steel and aluminum into fittings and components used in a car’s fluid systems – brake, cooling and power train. Three-quarters of the products are shipped eight times a week to parts makers in the U.S. and Mexico, where they are added to other components and sold to car makers for final assembly. Even the goods he sends to Canadian companies wind up crossing North American borders one way or another and would be hit by Mr. Trump’s promised 25-per-cent tariff. Mr. Vasudeva, who employs 45 people – most of them highly skilled machinists – is negotiating a $2-million sale to a U.S. customer. He fears the deal will be lost if Mr. Trump imposes the levy. “If he puts it on, we may not be competitive. We may lose the U.S. customer,” Mr. Vasudeva said. Mr. Trump’s promised tariffs on Canadian and Mexican imports ignited fears of economic devastation in much of Canada, which depends on the U.S. for 75 per cent of its exports. Makers of auto parts and vehicles in Canada employ about 125,000 people and exported $102-billion of products in 2023. Most of this went to the U.S. while $1.9-billion in goods were sent to Mexico, another major supplier to the U.S. Three-quarters of Ultra-Form Manufacturing's products are shipped eight times a week to parts makers in the U.S. and Mexico. Christopher Katsarov/The Globe and Mail Like other auto parts, the fittings turned out by Ultra-Form cross the U.S. and Mexican borders a few times before being becoming part of a finished vehicle. It’s this integrated nature of car-making that underpins the trade agreement upon which North America has relied for mostly tariff-free commerce. This interdependence has allowed companies in all three countries to invest in technology and compete for a piece of the massive U.S. market, which saw 15.5 million new vehicles sold in 2023. That’s why, for Mr. Vasudeva, the threat of a U.S. tariff is a betrayal. “We are like two brothers here,” he said. “We are not different. We pay the same wages. We have the same rules and laws. We have to be fair. Why we are being punished? If they have to punish [a trade partner], they should punish Mexico and China.” - Eric Atkins Arctic Snowplows Jim Estill is clear on what Canadian policymakers should do if the U.S. enacts steep tariffs: retaliate. Earlier this year, Mr. Estill acquired Arctic Snowplows, a London, Ont.-based manufacturer of heavy equipment for snow clearance, which has been in operation for 55 years. A “considerable amount” of their product is shipped to the U.S., he said, so any new duties would hurt their competitiveness in that market. If Mr. Trump followed through on the tariffs, Arctic Snowplows would refocus its sales efforts on Canada and not spend any marketing dollars in the U.S., Mr. Estill said. It’s possible the company could offset the loss of U.S. revenue with more business in Canada, he added. But this glass-half-full perspective hinges on whether Canada would respond to U.S. tariffs with its own, hampering the Canadian sales of Arctic’s American competitors. Mr. Estill has spoken with members of Parliament about taking this retaliatory approach, should the situation escalate. “None of this is good for consumers, because the lowest cost is the way it is right now,” he said. Mr. Estill is already familiar with the chaotic policy environment under Mr. Trump. He’s also the owner and CEO of Danby, which sells and manufactures appliances in Canada and the U.S. Under Mr. Trump’s watch, the U.S. brought in new tariffs on washing machines in 2018 to support the domestic industry. But like many of their competitors in the U.S. market, Danby imported their machines from overseas which meant they were subject to tariffs. Those added costs were passed on to consumers, Mr. Estill said. “If everybody has the same tax, then it’s kind of a level playing field, and nothing much changes except prices to consumers,” he said. Mr. Estill said the uncertain policy landscape makes it difficult for business owners to invest in their operations, which can ripple through the economy. “If I don’t put an addition on my plant, then the roofer doesn’t get paid, and then the roofer doesn’t go to the restaurant and spend their money, and then the waitress can’t go buy a bar fridge,” he said, referencing a Danby product. “That’s what the economy is, right?” -Matt Lundy AceTronic Industrial Controls Recessions, trade wars and a financial crisis – Kim Thiara has seen it all. Ms. Thiara is the owner of AceTronic Industrial Controls Inc., a 41-year-old Mississauga-based company that makes machinery and parts for manufacturers of plastic goods. Her customers make food packaging, car interiors and components, medical equipment and other products, most of which are exported to the U.S. AceTronic’s sales – and those of its customers – would be affected by Mr. Trump’s promise to tax Canadian and Mexican imports at 25 per cent. This would drive up costs to U.S. manufacturers and consumers and make Canadian goods less competitive with those from such low-wage regions as Asia. But ask Ms. Thiara about the prospect of the new tariff and she is sanguine. With fresh memories of Mr. Trump’s steel and aluminum tariffs, which were imposed during his first term, she expected another round of protectionism if he was elected. But she is optimistic the levy will not be as high as 25 per cent. “This isn’t our first storm. And this, too, shall pass,” Ms. Thiara said. “I think he’s just kind of saying that now, and just preparing us for what may be coming down the road.” She also doubts the U.S. will turn its back on a long-standing trade relationship in which the world’s largest economy benefits from a next-door partner that boasts rich resources and deep industrial knowledge. AceTronic brought back parts of its manufacturing processes from Asia during the pandemic, part of a trend known as “nearshoring” that allows it to better control its operations even if some costs rise. Her U.S. trading partners have also done this – one calls it “friendshoring” – and show they value a culturally similar neighbour who is a trusted supplier. “A lot of my customers this week were talking about the resources that Canada has to offer, the cobalt, the lithium, even hydro,” Ms. Thiara said. These resources include the southern Ontario automotive plastics sector in which AceTronic operates, she said. “Trump is a businessman at the end of the day,” she said, “and I can’t see him disregarding that resource.” -Eric Atkins Brink Group of Companies After 50 years in the softwood lumber business, this is one of the worst-case scenarios that John Brink has ever seen. “I’ve dealt with everything from recessions through inflation to duties and all that combined at times, but we survived it all. Now we’ve got a whole combination of all the above,” he said. Mr. Brink founded his lumber company in 1975 and now holds the title of CEO for the expanded Brink Group of Companies, which focuses on lumber, real estate, warehousing and media. The northern B.C.-based group employs around 400 people and exports more than 90 per cent of its product, mainly lumber, to the U.S. If Mr. Trump implements a 25-per-cent tariff on all imports from Canada, Mr. Brink said the impact to the industry would be devastating. Already, many Canadian softwood lumber companies are being forced to pay a 14.4-per-cent duty on imports to the U.S. and with this tariff, he expects many of them could be put out of business. “There’s no question about that,” he said. With additional tariffs, Mr. Brink predicts the cost of two-by-fours would soar, driving up U.S. home prices. While some industries have reacted to Mr. Trump’s tariff promise with skepticism, Mr. Brink said he’s not taking it lightly. “If it is a comment and a commitment that has been made by the president-elect and his name is Trump, we can take it seriously,” he said. However, he’s not worried about his own company’s survival. After 50 years in business, he said he has learned to keep a tight budget and an eye on the markets. But the inflation that would follow such a steep tariff, he said, is the most troubling part. “The customers will pay,” he said. -Pippa NormanChâtillon, France, December 11 th , 2024 DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study on-track to initiate in 2Q 2025 Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026 FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-old Company to host investor webcast today at 5:00pm ET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U.S. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 – 3-years-old. The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. DBV and FDA have agreed on the key design elements for a post-marketing confirmatory study. “DBV is pleased to have received, what we believe to be, a clear and reasonable pathway towards an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. This comes on the heels of our October 22 nd press release announcing details in support of our separate Viaskin Peanut programs in 4 – 7 year-olds and in 1 – 7 year-olds in Europe,” said Daniel Tassé, Chief Executive Officer, DBV Technologies. “We believe we have decreased the regulatory pathway risk of our programs. DBV can now fully focus on executing the remaining studies that will support two distinct BLAs across age groups and an MAA in Europe. We are grateful to the Agency for its attentive collaboration as we continue to work towards introducing this novel therapy to caregivers and patients as expeditiously as possible.” Accelerated Approval Pathway The FDA recently issued written communication confirming an Accelerated Approval pathway for the Viaskin Peanut patch in toddlers 1 – 3-years-old. As a reminder, current FDA guidance for Accelerated Approval includes three qualifying criteria: That the product candidate treats a serious condition That the product candidate generally provides a meaningful advantage over available therapies That the product candidate demonstrates an effect or an intermediate clinical endpoint that is reasonably likely to predict clinical benefit As DBV previously announced , FDA confirmed via written communication that the Viaskin Peanut patch already met criteria one and two. FDA and DBV have been engaged in ongoing dialogue throughout Q4 of this year regarding the intermediate clinical endpoint necessary to meet the third criterion. In the recent written communication, the FDA confirmed the efficacy data from the Company’s Phase 3 EPITOPE study can serve as an intermediate clinical endpoint. The FDA has agreed that the endpoint is reasonably likely to predict clinical benefit and will therefore fulfill the requirement for Accelerated Approval. In preparation for commercialization, DBV made slight modifications to the Viaskin Peanut patch used in EPITOPE to increase the simplicity of application for the caregiver and provide product identification on each patch. No changes, including patch shape or size, were made to the device components that are in contact with the patient’s skin. Further, to increase the volume of patch production for future commercialization, changes needed to be made to the manufacturing process and location. Although the intended commercial Viaskin Peanut patch is currently being used (N=304) in the ongoing 3-year Open Label Extension to EPITOPE, the collective changes to the commercial Viaskin Peanut patch were viewed by the FDA as constituting a different product relative to the clinical patch used in the EPITOPE study. The Company intends to use the commercial Viaskin Peanut patch in both the COMFORT Toddlers study and the post-marketing confirmatory study. Post-Marketing Confirmatory Study In the recent written communication, FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1 – 3-years-old. DBV and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted. To date, the commercial patch has been used in 304 subjects with over 234,695 patient-days of therapy in the placebo crossover and the EPITOPE Open Label Extension, with no clinically relevant differences in efficacy or safety vs. the clinical patch used in the EPITOPE Phase 3 trial. The confirmatory study will include a double-blind, placebo-controlled food challenge (DBPCFC) and will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE Phase 3 efficacy study. Adhesion data for the post-marketing confirmatory study will be collected in a similar manner relative to the COMFORT Toddlers study. The Company expects these data will further support the importance of average daily wear time in the use of the Viaskin Peanut patch as it relates to efficacy and labeling. “When it comes to food allergy management, what works for one family, might not work for another. That is why having varied treatment options available is so incredibly important to our community,” said Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research & Education). “I’m pleased to learn that DBV’s constructive dialogue with the FDA has resulted in this Accelerated Approval guidance outlining remaining developmental steps for the Viaskin Peanut patch in toddlers with a peanut allergy. At FARE, we look forward to the possibility that one day, if approved, caregivers and families will have this exciting new treatment as an option to consider.” COMFORT Toddlers Supplemental Safety Study COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled (DBPC) study designed to generate additional safety (primary endpoint) and adhesion data of the Viaskin Peanut patch in peanut allergic toddlers 1 – 3-years old. DBV is pleased to announce that Dr. Julie Wang, MD, Professor of Pediatrics, Jaffe Food Allergy Institute, the Icahn school of Medicine at Mount Sinai, will act as the Global Principal Investigator for the COMFORT Toddlers study. “I am thrilled to assume the role of Global Principal Investigator of the COMFORT Toddlers study,” stated Dr. Julie Wang, Professor of Pediatrics, Jaffe Food Allergy Institute, Icahn school of Medicine at Mount Sinai in New York. “Viaskin Peanut, if approved, would offer a much-needed alternative treatment option for patients and caregivers. I look forward to working with the DBV team to advance this important clinical trial.” The Company anticipates that COMFORT Toddlers will enroll approximately 480 subjects randomized 3:1 (active: placebo) at approximately 80 – 90 study centers across the U.S., Canada, Australia, and Europe. COMFORT Toddlers will be a six-month study followed by an optional 18-month open-label treatment phase, to provide 24 or 18 months of treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively. Thus, the COMFORT Toddlers study will increase the total subjects exposed to the Viaskin Peanut patch for at least six-months in a controlled study to 600, as required by FDA. In total, there will be approximately 240 subjects with the clinical patch in EPITOPE and 360 with the commercial patch in COMFORT Toddlers. As previously disclosed , DBV and FDA have aligned on a patch wear time collection methodology, analysis and study objective hierarchy in the COMFORT Toddlers study. The agreed-upon adhesion data collection methodology provides a practical approach for subjects, families, and investigators. The methodology is intended to generate sufficient data to support a BLA submission under the Accelerated Approval pathway (i.e., collecting patch adhesion data with a focus on daily wear time at relevant time points). We believe there are three positive outcomes coming out of the productive discussions with FDA: FDA agreed that adhesion would not be a co-objective of a safety study and would be an exploratory endpoint. Next, adhesion should be assessed in the overall totality of benefit to risk (i.e., in the context of efficacy and safety). The third success is that we have aligned on what DBV believes is a very feasible approach to collecting adhesion data. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. Biologic License Application Submission in 1 – 3 Year-Olds There will be two Phase 3 studies in 1 – 3-year-olds using the Viaskin Peanut patch. The data generated from the studies will be used to inform a BLA submission: Twelve months of DBPC efficacy and safety data from the previously completed Phase 3 EPITOPE study (published in the New England Journal of Medicine i n May 2023), and 36 months of open-label extension data. Six months of DBPC data generated in COMFORT Toddlers supplemental safety study. DBV anticipates that the BLA for the Viaskin Peanut patch in toddlers 1 – 3 years-old under the Accelerated Approval program will be submitted in 2H 2026. Investor Conference Call and Webcast DBV management will host an investor conference call and webcast today, Wednesday, December 11 th , at 5:00pm EST, to discuss these regulatory updates. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call. United States: +1-877-346-6112 International: +1-848-280-6350 A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/ . A replay of the presentation will also be available on DBV’s website after the event. About DBV Technologies DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary Viaskin® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPITTM), the Viaskin® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn . Forward Looking Statements This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of Viaskin® Peanut patch and EPITTM, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, plans and expectations regarding initiation of the confirmatory study, plans and expectations with respect to COMFORT Toddlers and COMFORT Children, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the BLA submission, DBV’s expectations with respect to the Accelerated Approval pathway and any other actionable regulatory pathway, and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. Viaskin is a registered trademark and EPIT is a trademark of DBV Technologies. Investor Contact Katie Matthews DBV Technologies katie.matthews@dbv-technologies.com Media Contact Angela Marcucci DBV Technologies angela.marcucci@dbv-technologies.com Attachment PDF Version
An incident above Oregon earlier this month may not be so easy to explain away, according to several people, including some with first-hand knowledge of the event. On the evening of Saturday, Dec. 7, multiple pilots reported unidentified red lights “zooming” around the sky over Oregon to air traffic controllers. See video of one of the sightings here: On a recording of one of the conversations, two pilots were perplexed by what they saw. “We’re seeing three or four targets,” one pilot said. “They’re all altitudes. Up and down. It’s pretty crazy.” The pilot describes the lights “shooting way up” into the range of 50,000 feet. “Just had another one show up,” said another pilot, who reported that the light was “zipping towards us and back out towards the ocean, red in color, moving at extreme speeds. I don’t even know how to describe it.” “You are cleared to maneuver as necessary left and right to avoid the UFO out there,” an air traffic controller told him. Tim Gallaudet, an oceanographer and retired rear admiral in the U.S. Navy who testified last month before Congress about government transparency when it comes to “unidentified anomalous phenomena,” the government’s term for unidentified flying objects or UFOs, sees the lights over Oregon as part of a trend of mysterious events witnessed by pilots. While one researcher told KGW that the lights appear “to be Starlink satellites, most likely,” Gallaudet and others don’t believe Oregon’s lights can be explained that way. “Nothing that we make can move like they were describing,” Gallaudet said Monday. “Starlink is pretty easy to observe and verify because the satellites seem to move in a pretty predictable orbit.” “Most pilots who see Starlink, they know they’re seeing Starlink,” he added. The Oregonian/OregonLive spoke with several people who had first-hand knowledge of the lights over Oregon. Those people, who were unable to go on the record out of concern for their jobs, said the lights did not move like Starlink or look like Starlink. And they do not believe they were Starlink. But they do not have a good explanation for what they are. Unlike the drones seen over the East Coast, these red lights have so far defied an easy explanation. At the time, the Federal Aviation Administration confirmed at least one of these sightings in a statement, saying, “A pilot reported seeing unidentified lights while flying in Seattle Air Route Traffic Control Center airspace on Saturday, Dec. 7.” The FAA has declined to offer any further information and the National Oceanic and Atmospheric Administration said the lights did not fall under their purview. Gallaudet sees that lack of explanation is part of a trend. In 2015, Gallaudet was serving as a meteorologist with the task of reducing flight safety risks for a naval exercise off the East Coast. “During this exercise, I received an email on the Navy’s secure network from the operations officer of Fleet Forces Command,” Gallaudet testified before Congress. “The text of the email was brief but alarming,” Gallaudet said, “with words to the effect: ‘If any of you know what these are, tell me ASAP. We are having multiple near-midair collisions, and if we do not resolve it soon, we will have to shut down the exercise.’” The email included a video of “an unidentified object exhibiting flight and structural characteristics unlike anything in our arsenal.” But, he told Congress, “The very next day, the email disappeared from my account and those of the other recipients without explanation.” Observing objects that have no explanation is not new. It’s so common that the government has an agency called the All-domain Anomaly Resolution Office that collects reports of UFOs. The official line, however, is that most of these mysterious celestial events do have a concrete explanation. The All-domain Anomaly Resolution Office did not immediately respond to a request for comment on the Oregon lights but Jon Kosloski, the director of the office, also testified before Congress in November. “Only a very small percentage of reports AARO receives are potentially anomalous,” Kosloski said. “These are the cases that require significant time, resources, and a focused scientific inquiry by AARO and its wide network of partners.” “It is important to underscore,” he added, “that, to date, AARO has discovered no verifiable evidence of extraterrestrial beings, activity, or technology.” Gallaudet isn’t so sure. “Something is happening we don’t fully understand,” he said. “Consider this,” Gallaudet said. “Our galaxy alone has between 100 and 400 billion stars. We know there are habitable planets around many stars and the observable universe has at least 2 trillion galaxies.” Gallaudet doesn’t know what the lights over Oregon were last week. But he thinks the official silence about those lights and other unexplained phenomena is because the government is worried about what will happen if they admit they don’t have total control over United States airspace. “We know life can evolve and is a property of this universe because we’re here,” he said. “How can we think, as big and old the universe is, we’re the only planet where that happened? It’s just really naive and myopic.” ©2024 Advance Local Media LLC. Visit oregonlive.com. Distributed by Tribune Content Agency, LLC.