LONDON–(BUSINESS WIRE)– Funds Date TIDM ISIN Code Shares in Issue Currency Net Asset Value NAV/per Share First Trust Vest U.S. Equity Buffer UCITS ETF – October 14.09.2026 FOCT.LN IE0004X8KUG5 100,002.00 USD 2,989,103.16 29.890
Month: September 2026
LONDON–(BUSINESS WIRE)– FORM 8.3 PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE Rule 8.3 of the Takeover Code (the “Code”) 1. KEY INFORMATION (a) Full name of discloser: Qube Research & Technologies Limited (b) Owner or controller of interests and short positions disclosed, if different from 1(a): The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiari
Bread Financial and Signet Jewelers partner to advance modernization, marketing capabilities and elevated experiences for Signet brands, including KAY, Zales, Jared and Blue Nile
COLUMBUS, Ohio, Sept. 15, 2026 (GLOBE NEWSWIRE) — Bread Financial® (NYSE: BFH), a tech-forward financial services company that provides simple, personalized payment, lending and saving solutions, today announced a long-term renewal of its relationship with Signet Jewelers Limited (NYSE: SIG).
The renewed agreement builds on the longstanding relationship between the two companies and supports the continued evolution of credit programs across Signet’s portfolio of brands. Under the long-term renewal agreement, Bread Financial and Signet will be focused on continued technology enhancements, robust analytics to enable data-driven marketing, customer experiences and credit capabilities to support Signet’s evolving business and customer needs.
“Bread Financial’s longstanding relationship with Signet is grounded in trust, collaboration and a shared focus on delivering exceptional customer experiences,” said Dennis McCarthy, executive vice president and chief revenue officer, Bread Financial. “Jewelry purchases mark some of life’s most meaningful moments, and we’re committed to supporting customers through those occasions with a credit experience that’s as seamless as it is significant. We will continue to support Signet with capabilities that evolve alongside its business, customer expectations and its portfolio of brands in this next phase of partnering together.”
Bread Financial currently supports most of Signet’s U.S. portfolio of brands through a range of credit solutions. The renewed agreement will add credit capabilities this fall for Blue Nile, a leading online retailer of fine jewelry and diamonds, further strengthening the companies’ shared commitment to serving customers across Signet’s portfolio.
“Our relationship with Bread Financial has been built on a strong foundation and this renewal reflects confidence in our ability to deliver a better experience for our customers,” said Joan Hilson, Chief Operating and Financial Officer of Signet Jewelers. “Together, we’re helping customers access flexible financing options that make celebrating life’s most special moments more attainable. As we continue to execute our Grow Brand Love strategy, we’re excited to deepen our partnership with Bread Financial, including the upcoming addition of Blue Nile ahead of this holiday season.”
About Bread Financial®
Bread Financial® (NYSE: BFH) is a tech-forward financial services company that provides simple, personalized payment, lending and saving solutions to millions of U.S. consumers. Our payment solutions deliver growth for some of the most recognized brands in travel & entertainment, health & beauty, technology, electronics, jewelry, home and specialty apparel through our co-brand and private label credit cards and pay-over-time products providing choice and value to our shared customers. Additionally, we offer Bread Financial general purpose credit cards and saving products that empower our customers and their passions for a better life.
Bread Financial proudly marks 30 years of success in 2026. To learn more about our global associates, our performance and our sustainability progress, visit breadfinancial.com or follow us on Instagram and LinkedIn.
About Signet Jewelers
As a Purpose-driven and sustainability-focused company, Signet is a participant in the United Nations Global Compact and adheres to its principles-based approach to responsible business. Signet operates approximately 2,500 stores primarily under the name brands of KAY Jewelers, Zales, Jared, Banter by Piercing Pagoda, Diamonds Direct, Blue Nile, Peoples Jewelers, H. Samuel and Ernest Jones. Further information on Signet is available at www.signetjewelers.com.
Five-year framework to explore connecting VEON’s digital services with Kazakhstan’s national payments infrastructure
DUBAI / ALMATY, 15 September 2026 – VEON Ltd. (Nasdaq: VEON) (“VEON”), a global digital operator, today announced that VEON Digital Financial Group (“VEON DFG”) and Beeline Kazakhstan have signed a Memorandum of Cooperation with the National Bank of Kazakhstan to explore the development of digital payment services in the country.
The memorandum establishes an initial five-year framework for cooperation, including exploring how VEON’s digital services could connect with Kazakhstan’s national payment and digital financial infrastructure. The aim is to make payments and money transfers more convenient and accessible within the digital services customers use every day.
Areas of potential cooperation include payment and money transfer processing, as well as settlement between financial market participants, using selected services and infrastructure offered by the National Payment Corporation.
The initiative supports VEON’s DO1440 strategy to expand its role in customers’ daily lives through digital services alongside connectivity. Developing financial services across its markets is a central part of this ambition, with VEON DFG intended to support the Group’s efforts to bring together and scale these businesses.
“Payments are an essential part of how customers engage with digital services every day,” said Ahmet Kayhan, Chief Payments & Digital Assets Officer of VEON. “Our ambition through VEON DFG is to build on the financial services capabilities across our markets and develop businesses that can serve more customers at greater scale. This memorandum provides a framework to explore how we can combine those capabilities with Kazakhstan’s national payments infrastructure, supporting our DO1440 strategy and long-term growth in digital financial services.”
Beeline Kazakhstan also intends to pursue first-category payment organization status to support the expansion of its payment services, subject to the applicable regulatory framework and all required approvals.
“Beeline Kazakhstan’s customer relationships and experience in digital services give us a strong foundation to make everyday payments more convenient,” said Jabbor Kayumov, CEO of Beeline Kazakhstan. “Working within this framework, we aim to explore services that fit naturally into our customers’ daily lives, drawing on the country’s national payments infrastructure and VEON’s financial services experience.”
The memorandum was signed at the Central Asia Fintech Summit in Almaty, hosted by the National Bank of Kazakhstan, the National Payment Corporation and the Kazakhstan Fintech Network.
The memorandum establishes a framework for cooperation; it does not itself authorize the launch of new financial services. Any resulting projects will be subject to regulatory, legal and technical review and will proceed only after all required approvals and procedures have been completed.
About VEON
VEON is a digital operator that provides connectivity and digital services to over 150 million connectivity and more than 228 million digital users. Operating across five countries that are home to more than 6% of the world’s population, VEON is transforming lives through technology-driven services that empower individuals and drive economic growth. VEON is listed on NASDAQ. For more information, visit: https://www.veon.com.
About Beeline Kazakhstan
Beeline Kazakhstan serves 11.7 million customers with mobile connectivity and around one million with fixed internet services. Since 2018, the company has been executing its digital operator strategy. Over the past five years, leveraging its expertise in digital solution development, Beeline Kazakhstan has created an ecosystem of 60 internal and external products. Beeline Kazakhstan is majority-owned by VEON.
Forward-Looking Statements
This release contains “forward-looking statements,” as the phrase is defined in Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, including in relation to VEON’s digital finance strategy and ambitions in Kazakhstan and its other markets.
Contact Information
VEON
pr@veon.com
Not for distribution to U.S. newswire services or dissemination in the United States.
TORONTO, Sept. 15, 2026 (GLOBE NEWSWIRE) — Flagship Communities Real Estate Investment Trust (“Flagship” or the “REIT”) (TSX:MHC.U) (TSX:MHC.UN) today announced a cash distribution of US$0.0545 per REIT unit for the month of September 2026, representing US$0.654 per REIT unit on an annualized basis. Payments will be made on or about October 15, 2026, to unitholders of record as of the close of business on September 30, 2026.
Distributions paid to Canadian unitholders (and other non-U.S. unitholders) generally will be subject to U.S. withholding tax. Unitholders should consult their own tax advisors for advice with respect to the tax consequences of receiving a distribution from the REIT in their own circumstance.
About Flagship Communities Real Estate Investment Trust
Flagship Communities Real Estate Investment Trust is a leading operator of affordable residential MHCs primarily serving working families seeking affordable home ownership. The REIT owns and operates exceptional residential living experiences and investment opportunities in family-oriented communities in Kentucky, Indiana, Ohio, Tennessee, Arkansas, Missouri, West Virginia, and Illinois. To learn more about Flagship, visit www.flagshipcommunities.com.
Forward-Looking Statements
This press release contains statements that include forward-looking information within the meaning of Canadian securities laws. These forward-looking statements reflect the current expectations of the REIT regarding future events, including statements concerning the intended monthly distributions of the REIT. In some cases, forward-looking statements can be identified by terms such as “may”, “will”, “could”, “occur”, “expect”, “anticipate”, “believe”, “intend”, “estimate”, “target”, “project”, “predict”, “forecast”, “continue”, or the negative thereof or other similar expressions concerning matters that are not historical facts. Material factors and assumptions used by management of the REIT to develop the forward-looking information include, but are not limited to, the REIT having sufficient cash to pay its distributions. While management considers these assumptions to be reasonable based on currently available information, they may prove to be incorrect.
Although management believes the expectations reflected in such forward-looking statements are reasonable and represent the REIT’s internal expectations and beliefs at this time, such statements involve known and unknown risks and uncertainties and may not prove to be accurate and certain objectives and strategic goals may not be achieved. A variety of factors, many of which are beyond the REIT’s control, could cause actual results in future periods to differ materially from current expectations of events or results expressed or implied by such forward-looking statements, such as the risks identified in the REIT’s final prospectus available under the REIT’s profile at www.sedar.com, including under the heading “Risk Factors” therein. Readers are cautioned against placing undue reliance on forward-looking statements. Except as required by applicable Canadian securities laws, the REIT undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made.
For further information, please contact:
Eddie Carlisle, Chief Financial Officer
Flagship Communities Real Estate Investment Trust
Tel: +1 (859) 568-3390
Milestone continues the progress towards detection of all 20 amino acids by end of 2026
BRANFORD, Conn., Sept. 15, 2026 (GLOBE NEWSWIRE) — Quantum-Si Incorporated (Nasdaq: QSI) (“Quantum-Si,” “QSI” or the “Company”), a proteomics company redefining protein analysis through single-molecule protein sequencing, today announced that it has demonstrated sequencing with detection of 18 amino acids using a developmental kit run on integrated Proteus™ instruments. The Company continues to expect to demonstrate detection of all 20 amino acids in 2026.
“Demonstrating detection of 18 amino acids and incorporating that capability into a developmental sequencing kit that has been successfully run on integrated Proteus instruments is a significant milestone for our company,” said Jeff Hawkins, President and Chief Executive Officer of Quantum-Si. “For over a year we have said that we would demonstrate detection of all 20 amino acids during 2026, and this result further increases our confidence in achieving that goal.”
Hawkins continued, “As we stated on our second quarter earnings call, the revised instrument timeline would allow us to progress further on amino acid recognizer development before finalizing our formulation for launch. The pace of improvement we are seeing continues to exceed our expectations, and by achieving detection of 18 amino acids now, we believe there is a potential to deliver all 20 amino acids in the commercial kit at launch.”
About Quantum-Si Incorporated
Quantum-Si is transforming proteomics with a benchtop platform that brings single-molecule protein analysis to every lab, everywhere. The Company’s platform enables real-time, kinetic-based detection and allows researchers to move beyond traditional, multistep workflows and directly access dynamic, functional protein insights with unparalleled resolution. By making protein analysis simpler, faster, and more informative, Quantum-Si is accelerating proteomic discoveries to improve the way we live. Learn more at quantum-si.com or follow us on LinkedIn or X.
Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. The actual results of the Company may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to future performance and development and commercialization of products, services and applications, its anticipated cash runway, the anticipated timing of product launches and product capabilities, including the expected amino acid detection capabilities of Proteus at launch, the Company’s current belief regarding remaining technical challenges associated with Proteus commercialization, the expected timing and successful completion of system integration, optimization, verification, validation and launch-readiness activities, the expected benefits of the Company’s development-process, organizational and cost-control actions, including the reduction in force, and any financial guidance.
These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. Many of these factors are outside the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the inability to maintain the listing of the Company’s Class A common stock on The Nasdaq Stock Market; the ability of the Company to grow and manage growth and retain its key employees; the Company’s ongoing leadership transitions and succession planning; the Company’s ability to successfully implement organizational changes, including workforce reductions, cost-control actions and development-process improvements, without disrupting product development, launch readiness, employee retention or customer engagement; the possibility that additional technical, integration, performance, reliability, verification, validation or launch-readiness challenges may arise or take longer or cost more to address than expected; changes in applicable laws or regulations; the ability of the Company to raise financing in the future; the success, cost and timing of the Company’s product development and commercialization activities, including the use and benefit of artificial intelligence in these and other activities; the commercialization and adoption of the Company’s existing products and the success of any product the Company may offer in the future, including Proteus; the potential attributes and benefits of the Company’s commercialized Platinum protein sequencing instruments and kits and the Company’s other products (including Proteus) once commercialized; the Company’s ability to obtain and maintain regulatory approval for its products, and any related restrictions and limitations of any approved product; the Company’s ability to identify, in-license or acquire additional technology; the Company’s ability to maintain its existing lease, license, manufacture and supply agreements; the Company’s ability to compete with other companies currently marketing or engaged in the development or commercialization of products and services that serve customers engaged in proteomic analysis, many of which have greater financial and marketing resources than the Company; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets once commercialized, either alone or in partnership with others; the Company’s estimates regarding future expenses, future revenue, capital requirements and needs for additional financing; the Company’s financial performance; the Company’s defense and initiation of litigation matters; and other risks and uncertainties described under “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and in the Company’s other filings with the SEC. The Company cautions that the foregoing list of factors is not exclusive. The Company cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.
Investor and Media Contact
Jeff Keyes
Chief Financial Officer
ir@quantum-si.com
From now until October 9, the campaign will support more than 300 women’s shelters and programs across Canada
TORONTO, Sept. 15, 2026 (GLOBE NEWSWIRE) — In Canada every five minutes a woman experiences intimate partner violence1, yet approximately 700 women and children are turned away from shelters each day.2 These stark realities underscore the urgent need for safe spaces and resources for women experiencing abuse.
This September, join Shoppers Foundation for Women’s Health™ in supporting more than 300 women’s shelters and programs across Canada by donating to the Giving Shelter campaign. Shoppers Drug Mart® and Pharmaprix® stores nationwide are raising funds for local organizations to help women and children find safety and take steps toward a life free from abuse.
“Gender-based violence is far more prevalent in Canada than many people realize,” says Paulette Minard, Director of Community Investment and Shoppers Foundation for Women’s Health. “This is a national issue and Giving Shelter is a national campaign, but the funds raised stay within the local community, giving Canadians an opportunity to help neighbours and friends who may be fleeing violence.”
From now until October 9, customers can participate in the fundraising campaign by rounding up their purchase total at checkout at any Shoppers Drug Mart or Pharmaprix store across the country. One hundred percent of donations remain in the communities where they are raised, helping local organizations provide women and children with the safety, services and resources they need.
“Safety changes everything. When a woman experiencing abuse reaches out for help, she needs to know there is somewhere safe to turn,” says Kim Ruse, CEO of FearIsNotLove, one of the local charities being supported this year. “Giving Shelter is more than a fundraising campaign – it is our community saying that violence in our homes matters, and that no woman or family should face it alone. Through Giving Shelter, we can come together to provide the support women and families need to move toward safety and healing, and ultimately a life free from violence and abuse.”
This year’s campaign will also offer Canadians a special opportunity to make their support go even further. From September 25 to 27, Shoppers Foundation for Women’s Health will match funds raised through in-store round up and online donations, up to a total of $150,000, helping generate even more support for local women’s shelters and programs.
To donate or to learn more about Giving Shelter, visit shoppersfoundation.ca.
_______________
1 Statistics Canada, The Daily Trends in police-reported family violence and intimate partner violence in Canada, 2025
2 Women’s National Housing and Homelessness Network, Global News, November 2024
About Shoppers Foundation for Women’s Health™
Shoppers Foundation for Women’s Health™ – the charitable arm of Shoppers Drug Mart® – is committed to helping Canadian women lead healthier lives, by making care more equitable and accessible. In 2022, the Foundation set an ambitious goal: to contribute $50M by 2026 towards women’s health initiatives that are making care more equitable and accessible. This milestone has been surpassed, ahead of schedule, and Shoppers Foundation remains steadfast in its commitment to build a future in which more women in Canada can lead healthier lives.” Learn more at shoppersfoundation.ca.
About Shoppers Drug Mart Inc.
Shoppers Drug Mart Inc. is one of the most recognized and trusted names in Canadian retailing. The company is the licensor of full-service retail drug stores operating under the name Shoppers Drug Mart® (Pharmaprix® in Québec). With more than 1,350 Shoppers Drug Mart® and Pharmaprix® stores operating in prime locations in each province and two territories, the company is one of the most convenient retailers in Canada. The company also licenses or owns more than 150 medical clinic pharmacies operating under the name Shoppers Simply Pharmacy® (Pharmaprix Simplement Santé® in Québec). In addition to its retail store network, the company owns Shoppers Drug Mart Specialty Health Network Inc., a provider of specialty drug distribution, pharmacy and comprehensive patient support services, MediSystem Inc., a provider of pharmaceutical products and services to long-term care facilities and Lifemark Health Group, Canada’s leading provider of outpatient physiotherapy, massage therapy, occupational therapy, chiropractic, mental health, and other ancillary rehabilitation services. Shoppers Drug Mart® is an independent operating division of Loblaw Companies Limited.
For all media inquiries, contact: pr@loblaw.ca.
NEW YORK, Sept. 15, 2026 (GLOBE NEWSWIRE) — OTC Markets Group Inc. (OTCQX: OTCM), operator of regulated markets for trading 12,000 U.S. and international securities, today announced Challenger Gold Limited (ASX: CEL; OTCQX: CLLEF), a gold and copper exploration company, has qualified to trade on the OTCQX® Best Market. Challenger Gold Limited upgraded to OTCQX from the OTCQB® Venture Market.
Challenger Gold Limited begins trading today on OTCQX under the symbol “CLLEF.” U.S. investors can find current financial disclosure and Real-Time Level 2 quotes for the company on www.otcmarkets.com.
The OTCQX Market is designed for established, investor-focused U.S. and international companies. To qualify for OTCQX, companies must meet high financial standards, follow best practice corporate governance, and demonstrate compliance with applicable securities laws. Graduating to the OTCQX Market marks an important milestone for companies, enabling them to demonstrate their qualifications and build visibility among U.S. investors.
“Our graduation to the OTCQX Best Market is an important milestone and reflects Challenger Gold’s commitment to expanding its presence in North American capital markets. We believe the OTCQX quotation will enhance our visibility with U.S. investors, broaden market participation, and contribute to increased liquidity in our shares. This is also an important step in our strategy to access additional trading platforms and a wider pool of institutional investors as we advance the Hualilán Gold Project toward commercial production,” said Yohann Bouchard, Interim Chief Executive Officer of Challenger Gold Limited.
Trading in Asia Pacific securities on the OTC Markets reached U.S. $19.49B in the second quarter of 2026, representing a 34.1% increase over Q2 2025. OTC Markets recorded U.S. $453.34B in total dollar volume in the first half of the year. Australia ranked among the top home markets by trading volume during the quarter, highlighting sustained U.S. investor demand for internationally listed names.
About Challenger Gold Limited
Challenger Gold Limited engages in the exploration of gold, silver, and copper deposits. Its flagship project is the Hualilan Gold project that comprise 15 mining leases and an exploration license application covering an area of 26 square kilometers located in San Juan, Argentina.
About OTC Markets Group Inc.
OTC Markets Group Inc. (OTCQX: OTCM) operates regulated markets for trading 12,000 U.S. and international securities. Our data-driven disclosure standards form the foundation of our public markets: OTCQX® Best Market, OTCQB® Venture Market, OTCID™ Basic Market and Pink Limited™ Market. Our OTC Link® Alternative Trading Systems (ATSs) provide critical market infrastructure that broker-dealers rely on to facilitate trading. Our innovative model offers companies more efficient access to the U.S. financial markets.
OTC Link ATS, OTC Link ECN, OTC Link NQB, OTC Overnight® and MOON ATS® are each an SEC regulated ATS, operated by OTC Link LLC, a FINRA and SEC registered broker-dealer, member SIPC.
To learn more about how we create better informed and more efficient markets, visit www.otcmarkets.com.
Media Contact:
OTC Markets Group Inc., +1 (212) 896-4428, media@otcmarkets.com
COLUMBUS, Ohio, Sept. 15, 2026 (GLOBE NEWSWIRE) — Bread Financial Holdings, Inc. (NYSE: BFH), a tech-forward financial services company that provides simple, personalized payment, lending, and saving solutions to millions of U.S. consumers, provided a performance update. The following tables present the Company’s Net principal loss rate and Delinquency rate for the periods indicated:
| For the month ended August 31, 2026 |
For the month ended August 31, 2025 |
||||||
| (dollars in millions) | |||||||
| End-of-period credit card and other loans | $ | 18,730 | $ | 17,657 | |||
| Average credit card and other loans | $ | 18,588 | $ | 17,598 | |||
| Year-over-year change in average credit card and other loans | 5.6 | % | (0.9 | %) | |||
| Net principal losses | $ | 101 | $ | 113 | |||
| Net principal loss rate | 6.40 | % | 7.57 | % | |||
| As of August 31, 2026 |
As of August 31, 2025 |
||||||
| (dollars in millions) | |||||||
| 30 days + delinquencies – principal | $ | 885 | $ | 934 | |||
| Period ended credit card and other loans – principal | $ | 16,512 | $ | 16,001 | |||
| Delinquency rate | 5.36 | % | 5.84 | % | |||
About Bread Financial®
Bread Financial®(NYSE: BFH) is a tech-forward financial services company that provides simple, personalized payment, lending and saving solutions to millions of U.S. consumers. Our payment solutions deliver growth for some of the most recognized brands in travel and entertainment, specialty apparel, health and beauty, jewelry, sporting goods, technology and electronics, as well as home and furniture through our co-brand and private label credit cards and pay-over-time products providing choice and value to our shared customers. Additionally, we offer Bread Financial general purpose credit cards and saving products that empower our customers and their passions for a better life.
Bread Financial proudly marks 30 years of success in 2026. To learn more about our global associates, our performance and our sustainability progress, visit breadfinancial.com or follow us on Instagram and LinkedIn.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements give our expectations or forecasts of future events and can generally be identified by the use of words such as “believe,” “expect,” “anticipate,” “estimate,” “intend,” “project,” “plan,” “likely,” “may,” “should” or other words or phrases of similar import. Similarly, statements that describe our business strategy, outlook, objectives, plans, intentions or goals also are forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements we make regarding, and the guidance we give with respect to, our anticipated operating or financial results, future financial performance and outlook, future dividend declarations, and future economic conditions.
We believe that our expectations are based on reasonable assumptions. Forward-looking statements, however, are subject to a number of risks and uncertainties that are difficult to predict and, in many cases, beyond our control. Accordingly, our actual results could differ materially from the projections, anticipated results or other expectations expressed in this release, and no assurances can be given that our expectations will prove to have been correct. Factors that could cause the outcomes to differ materially include, but are not limited to, the following: macroeconomic conditions, including inflation, interest rates, labor market conditions, financial and capital market conditions, recessionary pressures or concerns over a prolonged economic slowdown, and the related impact on consumer spending behavior, payments, debt levels, savings rates and other behaviors; global political events and conditions, including significant shifts in trade policy, such as changes to, or the imposition of, tariffs and/or trade barriers and consequently any economic impacts, volatility, uncertainty and geopolitical instability resulting therefrom, as well as ongoing wars and military conflicts, and international tensions or hostilities; local or global public health issues, climate-related events, impacts to the power grid, and natural disasters; future credit performance, including the level of future delinquency and charge-off rates; loss of, or reduction in demand for services and/or products from, significant brand partners or customers in the highly competitive markets in which we operate, including competition from new and non-traditional competitors, such as financial technology companies, and with respect to new products, services and technologies, such as the emergence or increase in popularity of agentic commerce, digital payment platforms and currencies and other alternative payment and deposit solutions; the concentration of our business in U.S. consumer credit; inaccuracies in the models and estimates on which we rely, including our credit risk management models and the amount of our Allowance for credit losses; the inability to realize the intended benefits of acquisitions, dispositions and other strategic initiatives; our level of indebtedness and ability to access financial or capital markets; pending and future federal and state legislation, executive action, regulation, supervisory guidance, and regulatory and legal actions, including, but not limited to, those related to financial regulatory reform and consumer financial services practices, as well as any such actions that would place limits on credit card interest rates or late fees, interchange fees or other charges; failures or breaches in our operational or security systems, including as a result of cyberattacks, unanticipated impacts from technology modernization projects or otherwise; and any liability or other adverse impacts arising out of or related to the spinoff of our former LoyaltyOne segment or the bankruptcy filings of Loyalty Ventures Inc. (LVI) and certain of its subsidiaries, including the pending litigation against us in connection with the spinoff. The foregoing factors, along with other risks and uncertainties that could cause actual results to differ materially from those expressed or implied in forward-looking statements, are described in greater detail under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the most recently ended fiscal year, which may be updated in Item 1A of, or elsewhere in, our Quarterly Reports on Form 10-Q filed for periods subsequent to such Form 10-K. Our forward-looking statements speak only as of the date made, and we undertake no obligation, other than as required by applicable law, to update or revise any forward-looking statements, whether as a result of new information, subsequent events, anticipated or unanticipated circumstances or otherwise.
Contacts
Brian Vereb — Investor Relations
Brian.Vereb@breadfinancial.com
Susan Haugen — Investor Relations
Susan.Haugen@breadfinancial.com
Rachel Stultz — Media
Rachel.Stultz@breadfinancial.com
45% objective response rate and 88% disease control rate observed in patients with EGFR C797S-positive resistance to prior EGFR inhibitors, with or without concurrent T790M, a difficult-to-treat population with no approved targeted therapies
BH-30643 demonstrated a favorable safety profile with low rates of dose reduction or discontinuation due to treatment-related adverse events
Presentation follows receipt of FDA Fast Track designation for BH-30643 for the treatment of advanced or metastatic EGFR C797S-positive NSCLC
SAN DIEGO, Sept. 15, 2026 (GLOBE NEWSWIRE) — BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, today announced updated data from the ongoing Phase 1/2 SOLARA trial of BH-30643 in non-small cell lung cancer (NSCLC) patients with secondary epidermal growth factor receptor (EGFR) resistance mutations such as EGFR C797S. The data were highlighted in a mini-oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer in Seoul, South Korea.
BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR™ inhibitor designed to overcome the limitations of currently approved EGFR inhibitors for the treatment of EGFR-mutant NSCLC. In patients with EGFR C797S-positive resistance to prior EGFR inhibitor treatment, with or without concurrent T790M, BH-30643 demonstrated a 45% objective response rate (ORR; 18/40) and an 88% disease control rate (DCR; 35/40). At the time of efficacy follow-up, 63% (25/40) of patients remained on treatment with a median follow-up of 6.9 months. BH-30643 also demonstrated a favorable safety profile with low rates of dose reduction or discontinuation due to treatment-related adverse events.
“C797S-driven resistance to third-generation EGFR inhibitors was first described over 10 years ago, yet patients whose tumors develop this mutation currently have no approved targeted treatment options,” said Hidehito Horinouchi, M.D., Ph.D., National Cancer Center Hospital, Tokyo, and presenting author of the study. “The responses observed with BH-30643 in this heavily pretreated population, together with encouraging early evidence of durability, support the potential of BH-30643 to directly target this resistance mechanism. These results are particularly encouraging given the need for new precision treatment options that can extend the benefits of targeted therapy for patients with EGFR-mutant lung cancer.”
“These updated results provide important clinical validation of the approach we took in intentionally designing BH-30643 to address on-target EGFR resistance, including C797S,” said Geoff Oxnard, M.D., Chief Medical Officer of BlossomHill Therapeutics. “We are encouraged to see meaningful anti-tumor activity across a molecularly diverse group of patients with C797S-positive disease, including patients with concurrent T790M and those who have received multiple prior therapies, with a favorable safety profile. Together with the recent FDA Fast Track designation, these data strengthen our conviction in the potential of BH-30643 and support our plans to advance into a Phase 2 trial in patients with C797S-positive NSCLC in 2027.”
Presentation highlights:
As of the May 12, 2026 data cutoff, with efficacy follow-up through August 10, 2026:
- Encouraging anti-tumor activity was observed in patients with C797S-positive resistance. Among 40 patients with EGFR C797S-positive resistance to prior EGFR inhibitor treatment, with or without concurrent T790M, 18 patients achieved a confirmed (16) or ongoing unconfirmed (2) partial response, representing an ORR of 45% (95% CI: 29%-62%). The DCR was 88% (35/40), and 25 patients (63%) remained on treatment at the time of efficacy follow-up. Median follow-up was 6.9 months.
- Activity was observed across a clinically heterogeneous, previously treated population. Patients had received a median of two prior lines of therapy; 98% had received prior osimertinib, 53% had received prior chemotherapy and/or an antibody-drug conjugate, and 53% had a history of brain metastases. 35% of patients had concurrent T790M.
- BH-30643 demonstrated a favorable safety profile at expansion doses. Among 174 patients treated at doses of 40 mg, 50 mg and 60 mg twice daily, treatment-related dose reductions and discontinuations occurred in 9% and 3% of patients, respectively. EGFR wild-type-associated treatment-related adverse events were primarily Grade 1. The most common treatment-related adverse event was bilirubin elevation, which was generally asymptomatic and predominantly unconjugated, consistent with UGT1A1 inhibition by BH-30643.
- Development of BH-30643 is continuing across multiple EGFR-mutant populations. Expansion cohorts are evaluating on-target resistance mutations, targeted therapy-naive patients and BH-30643 in combination with chemotherapy. BlossomHill plans to initiate a global Phase 2 study targeting EGFR C797S-positive NSCLC in Q1 2027.
The presentation is available on the company’s Posters & Presentations page here: https://bhtherapeutics.com/pipeline/#posters-and-presentations.
About BH-30643
BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR™ inhibitor for the treatment of EGFR-mutant NSCLC. BH-30643 was designed to overcome the limitations of currently approved EGFR inhibitors, which were discovered over a decade ago without the current, modern understanding of the structure and protein dynamics of mutant EGFRs. In preclinical studies, BH-30643 demonstrated potent inhibitory activity across diverse EGFR mutation categories – classical mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations and exon 20 insertions – while maintaining marked selectivity over wild-type EGFR. BH-30643 has received Fast Track designation and is being evaluated in SOLARA, a global Phase 1/2, first-in-human clinical trial spanning more than 40 sites in 10 countries. Ongoing dose expansion cohorts are enrolling in both TKI-pretreated and TKI-naive settings, including a C797S resistance cohort. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).
About the SOLARA Trial
The Phase 1/2 SOLARA clinical trial (NCT06706076) is a global, open label, multicenter study assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC). Phase 1 will determine the recommended Phase 2 dose (RP2D) of BH-30643 as a monotherapy and in combination with chemotherapy. Phase 2 is designed to evaluate the antitumor efficacy and safety in specified cohorts determined by mutation subtypes and/or treatment history at the RP2D, as well as the population pharmacokinetics.
About BlossomHill Therapeutics
BlossomHill Therapeutics, Inc. is a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines that address significant unmet medical needs in cancer treatment. Founded and led by industry veteran J. Jean Cui, Ph.D., with her proven track record in oncology drug design and development – including three FDA-approved drugs – BlossomHill Therapeutics applies cutting-edge science with a goal to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers. The company’s lead clinical program is BH-30643, an investigational, non-covalent, macrocyclic, brain active, mutant-selective OMNI-EGFRTM inhibitor for the treatment of EGFR-mutant non-small cell lung cancer (NSCLC), which has received Fast Track designation for the C797S resistance population after 3rd generation EGFR TKI treatment. The company is also conducting clinical development of BH-30236, an investigational macrocyclic CDC-like kinase (CLK) inhibitor initially being studied in a clinical trial for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndromes (HR-MDS). The company’s pipeline also includes BH-501284, a preclinical, non-covalent, selective, pan-KRAS Switch-II inhibitor for potential future development in diverse KRAS-mutant tumors.
BlossomHill Therapeutics is headquartered in San Diego, California. For more information, visit bhtherapeutics.com and follow us on LinkedIn and X.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws, including, without limitation, statements regarding: the therapeutic potential, clinical benefits, safety and potential competitive differentiation of the company’s product candidates, including BH-30643, BH-30236 and BH-501284; the anticipated benefits of regulatory designations received, or that may be received, by the company’s product candidates; the design, enrollment, timing, progress and results of the company’s clinical trials and preclinical studies; the company’s planned regulatory interactions and submissions; anticipated program milestones, announcements and updates, including the initiation of the Phase 2 study for BH-30643 in Q1 2027; statements by the company’s management; and the company’s development plans and continued advancement of its pipeline. The words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “upcoming,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially, including, without limitation: the company’s limited operating history, history of significant losses and the early stage of development of its product candidates; the risk that preliminary and interim clinical data are subject to further analysis and may not be predictive of, may be inconsistent with, or may be more favorable than, data generated as clinical trials continue or data from future clinical trials; uncertainties inherent in the initiation, timing, design and enrollment of clinical trials, and the availability and timing of data from ongoing and future trials; the company’s ability to successfully demonstrate the safety and efficacy of its product candidates and to obtain and maintain regulatory approvals; the timing and outcome of planned interactions with, and submissions to, the FDA and other regulatory authorities, including whether an accelerated approval pathway will be available to the company; the risk that regulatory designations, including Fast Track and orphan drug designation, may not result in a faster development, review or approval process, do not increase the likelihood of regulatory approval, and may be withdrawn; competition from third parties that are developing products for similar indications; the prior success of the company’s management team not being indicative of future success; the company’s reliance on third parties, including contract research organizations and contract manufacturing organizations; the company’s ability to obtain, maintain and protect its intellectual property; and the company’s need for additional financing and its estimates regarding operating expenses and capital requirements. These and other risks are described in greater detail under the heading “Risk Factors” in the company’s final prospectus filed with the Securities and Exchange Commission (the “SEC”) on August 7, 2026 pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended, as well as in the company’s subsequent filings with the SEC. Any forward-looking statements represent the company’s views only as of the date of this press release, and the company expressly disclaims any obligation to update any forward-looking statements, except as required by law.
Company Contact:
Michael Moore, BlossomHill Therapeutics
michael.moore@bhtherapeutics.com
Media:
Ashlea Kosikowski, 1AB
ashlea@1abmedia.com
