Market Newsdesk

CALGARY, AB, Dec. 17, 2025 /PRNewswire/ – Vermilion Energy Inc. (“Vermilion” or the “Company”) (TSX: VET) (NYSE: VET) announces that it has filed an early warning report (the “Early Warning Report”) in respect of its holdings in Coelacanth Energy Inc. (“Coelacanth”).

On December 17, 2025, Vermilion sold 26,000,000 common shares (“Common Shares”) of Coelacanth through privately negotiated transactions with various sellers, at a price of $0.76 per Common Share for a purchase price of $19,760,000 (the “Transactions”), representing an amount equal to more than 2% of the issued and outstanding Common Shares thereby triggering the requirement to file the Early Warning Report.

Prior to the Transactions, Vermilion had ownership, control or direction over an aggregate of 80,179,104 Common Shares, representing approximately 15.0% of the issued and outstanding Common Shares. Following the Transactions, Vermilion has ownership, control and direction over an aggregate of 54,179,104 Common Shares, representing approximately 10.2% of the issued and outstanding Common Shares.

The Common Shares were sold in continuance of Vermilion’s stated priority of reducing its debt to further enhance the resiliency of its business. Vermilion will continue to review its holdings of Common Shares, and, depending on market conditions, general economic conditions and industry conditions, an amendment to the investor rights agreement with Coelacanth, as applicable, and/or other relevant factors, may, in the future, increase or decrease its investment in the securities of Coelacanth. Following the Transactions, Vermilion may not sell more than 4,000,000 Common Shares held by it without the consent of Coelacanth pursuant to the foregoing amendment.

This news release is being issued in accordance with National Instrument 62-103 – The Early Warning System and Related Take-Over Bid and Insider Reporting Issues in connection with the filing of the Early Warning Report. The Early Warning Report has been filed under Coelacanth’s profile on SEDAR+ and can be viewed at www.sedarplus.ca.

About Vermilion

Vermilion is a global gas producer that seeks to create value through the acquisition, exploration and development of liquids-rich natural gas in Canada and conventional natural gas in Europe while optimizing low-decline oil assets. This diversified portfolio delivers outsized free cash flow through direct exposure to global commodity prices and enhanced capital allocation optionality.

Vermilion’s priorities are health and safety, the environment, and profitability, in that order. Nothing is more important than the safety of the public and those who work with Vermilion, and the protection of the natural surroundings. In addition, the Company emphasizes strategic community investment in each of its operating areas.

Vermilion trades on the Toronto Stock Exchange and the New York Stock Exchange under the symbol VET.

View original content to download multimedia:https://www.prnewswire.com/news-releases/vermilion-energy-inc-sells-additional-common-shares-of-coelacanth-energy-inc-302645282.html

SOURCE Vermilion Energy Inc.

CHARLOTTE, N.C., Dec. 17, 2025 /PRNewswire/ — cbdMD, Inc. (NYSE American: YCBD), one of the nation’s leading, highly trusted and widely recognized CBD companies, today announces that it will host a conference call at 4:20 p.m., Eastern Time, on Friday, December 19, 2025, to discuss the company’s September 30, 2025 fourth quarter and fiscal year 2025 financial results and business progress.

CONFERENCE CALL DETAILS

Friday, December 19, 2025, 4:20 p.m. Eastern Time

USA/Canada: 888-880-3330

Webcast/Webcast Replay link – available through December 19, 2026:

https://app.webinar.net/13voDmbBlxj

About cbdMD, Inc.

cbdMD, Inc. (NYSE American: YCBD) is one of the leading and most highly trusted and most recognized cannabidiol (CBD) brands with a comprehensive line of U.S. produced THC-free¹ CBD products and an array of Farm Act compliant Delta 9 products. Our Paw CBD brand of pet products includes veterinarian-formulated products and our ATRx brand features functional mushroom products. In addition, we operate Herbal Oasis, a premium, award winning THC-infused social seltzer that blends cannabinoids and nootropic mushrooms to deliver a fast-acting, functional beverage made for presence and connection. With an alcohol-free formula and wellness-forward ingredients, Oasis invites a better way to drink-one rooted in clarity, balance, and joy. To learn more about cbdMD and our comprehensive line of U.S. grown, THC-free¹ CBD and Full Spectrum products as well as our other brands, please visit www.cbdmd.com, www.pawcbd.com, ATRxlabs.com, or Herbaloasis.com, follow cbdMD on Instagram and Facebook, or visit one of the thousands of retail outlets that carry cbdMD’s products.
(1) THC-free is defined as below the level of detection using validated scientific analytical methods.

Contact Information:

cbdMD, Inc.
Ronan Kennedy, CEO and CFO
Phone: +1 (704) 445-3064
email: [email protected]

View original content to download multimedia:https://www.prnewswire.com/news-releases/cbdmd-inc-to-host-conference-call-to-discuss-september-30-2025-fourth-quarter-and-fiscal-year-2025-results-302645275.html

SOURCE cbdMD, Inc.

Strategic collaboration aims to enhance operational efficiency and mitigate risks by transitioning to a business process more aligned with regulatory requirements

HONG KONG, Dec. 17, 2025 /PRNewswire/ — Cognizant (Nasdaq: CTSH) today announced a strategic collaboration with Bupa Hong Kong, a leading health insurance specialist in Hong Kong, to deliver Cognizant’s first AI-driven Business-Process-as-a-Service (BPaaS) solution for claims modernization in the region. The five-year engagement represents the largest Intuitive Operations and Automation (IOA) services deal for Cognizant in Hong Kong.

Utilizing Cognizant’s advanced expertise in AI-driven technologies, the new BPaaS solution integrates cloud-native technologies, generative AI-led claims automation and comprehensive fraud, waste, and abuse (FWA) detection. This cohesive strategy is designed to enhance Bupa’s productivity, support Bupa’s efforts to strengthen regulatory compliance and improve customer experience. The new solution aims to drive key KPIs for Bupa including faster claims processing, increased customer satisfaction and greater operational efficiency. The solution also aids streamline regulatory adherence and supports Bupa in consolidating talent, knowledge and resources to help enable more agile workflows. By decreasing average handling times and increasing automation, Bupa Hong Kong aims to increase its Net Promoter Scores, further solidifying its position as a leader in Hong Kong’s health insurance sector.

“We’re delighted to collaborate with Cognizant to adopt an AI-first approach aiming to streamline claims processing, reduce operational friction and mitigate risks – setting a new standard in health insurance,” said Earvin Lim, Chief Information Officer at Bupa Hong Kong. “This collaboration marks an important milestone for Bupa Hong Kong as we embrace cutting-edge technologies to deliver even greater value to our customers. By leveraging Cognizant’s expertise in AI-driven automation and cloud-native solutions, we are confident that this collaboration will not only help accelerate claims modernization but also support Bupa’s regulatory compliance objectives and enhance customer satisfaction. Our vision is to lead the market in operational excellence, drive forward innovation that ultimately improves healthcare outcomes for the communities we serve in Hong Kong and beyond.”

“Our collaboration with Bupa Hong Kong reflects Cognizant’s shared commitment to innovation and delivering exceptional value to customers through AI-enabled operations, with this first-of-its-kind agreement in the region,” said Ganesh Ayyar, President of Intuitive Operations and Automation and Industry Solutions Group at Cognizant. “At Cognizant, we believe the foundation of transformative AI lies in data. By addressing data debt and harnessing our AI Training Data Services, we’re turning complexity into clarity—fueling intelligent systems that learn, adapt and scale under client-defined parameters.”

“This relationship demonstrates our dedication to advancing digital transformation across the region,” said Thomas Mathew, Vice President of ASEAN & Greater China at Cognizant. “As the collaboration develops, we see significant opportunities to support Bupa’s technology and operational ambitions to deliver our BPaaS expertise more widely and deliver transformative solutions at scale. We look forward to working closely with Bupa to help shape the future of healthcare services for millions of people.”

About Cognizant:

Cognizant (Nasdaq: CTSH) engineers’ modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we’re improving everyday life. See how at http://www.cognizant.com or @cognizant.

Bupa – A health insurance specialist

Bupa is an international healthcare group dedicated to helping people live longer, healthier, happier lives and making a better world for over 70 years. We serve more than 38 million customers worldwide. With no shareholders, we reinvest our profits into enhancing healthcare for the benefit of current and future customers. 

Bupa has been a health insurance specialist in Hong Kong since 1976, offering one-stop solutions across domestic and international health insurance, and healthcare services. Our comprehensive medical insurance schemes are tailored to meet individual needs, and we provide health solutions for companies of all sizes. We also have a team of registered nurses, health management professionals, and doctors who provide various expert healthcare support.

Our healthcare provision arm, Quality HealthCare Medical Services (QHMS), became part of Bupa in October 2013. QHMS offers Western Medicine, Traditional Chinese Medicine, Diagnostics & Imaging, Dental, Physiotherapy, Mental Health and Wellness services via a network of over 1,650 provider service points in Hong Kong. 

For more information, visit www.bupa.com.hk/en/.

For more information about Cognizant and for media inquiries, please contact: [email protected].

For more information about Bupa Hong Kong and for media inquiries, please contact Wendy Leung at [email protected].

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/bupa-hong-kong-has-selected-cognizant-to-deliver-an-ai-driven-bpaas-solution-to-transform-health-insurance-claims-302645054.html

SOURCE Cognizant Technology Solutions

RYBREVANT FASPRO™, the first and only subcutaneous therapy for patients with EGFR-mutated NSCLC, reduces administration time from hours to minutes and significantly reduces administration-related reactions^1-5

Approval builds on previously reported Phase 3 MARIPOSA data showing unmatched overall survival benefit of this chemotherapy-free regimen, projected to exceed four years⁶

HORSHAM, Pa., Dec. 17, 2025 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).¹ RYBREVANT FASPRO™ is approved across all indications of RYBREVANT^® (amivantamab-vmjw).

Experience the full interactive Multichannel News Release here: https://www.multivu.com/johnson-and-johnson/9361151-en-johnson-and-johnson-us-fda-approval-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj 

Compared to intravenous (IV) delivery, RYBREVANT FASPRO™ offers significantly higher patient convenience and lower burden on healthcare resources^1-5:

• Reducing administration time from several hours to five minutes (significantly less administration time than chemotherapy-based regimens, which could take up to an hour);
• Demonstrating an approximately fivefold reduction in administration-related reactions (ARRs) (13 percent in SC vs 66 percent in IV arm); and
• Reducing venous thromboembolism (VTE) incidence (11 percent in SC vs 18 percent in IV arm).

Multimedia assets for media are available 

here

.

Based on the results from the Phase 3 PALOMA-3 study (NCT05388669), RYBREVANT FASPRO™ delivered consistent results to RYBREVANT^®, meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood [C_trough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUC_D1-D15)].^1,7 Results from PALOMA-3 were first presented as a late-breaking oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology. 

Data presented at ASCO in 2024 and published in the Journal of Clinical Oncology also found that the SC arm showed longer duration of response (DoR), improved progression-free survival (PFS), and longer overall survival (OS) compared to the IV arm. Median OS was notably higher for patients treated with the SC arm in combination with LAZCLUZE^® (HR 0.62; 95 percent CI, 0.42–0.92; nominal P=0.02). At 12 months, 65 percent of patients receiving SC were alive, compared with 51 percent treated with IV.⁷

“Patients now have a simple, chemotherapy-free frontline option that not only targets the disease more precisely but also significantly improves survival,” said Joelle Fathi, D.N.P., Chief Healthcare Delivery Officer, GO2 for Lung Cancer.^* “With the introduction of RYBREVANT FASPRO, care becomes faster, less invasive, and more aligned with what matters most to patients: time, comfort, and dignity. This therapy reduces the physical and emotional burden of lengthy infusions, giving patients and their families the opportunity to reclaim precious moments and focus on living, rather than treatment.”

This milestone builds upon the statistically significant and clinically meaningful OS data demonstrated with RYBREVANT^® plus LAZCLUZE^® for patients with untreated (first-line) locally advanced or metastatic NSCLC with EGFR exon 19 deletions (ex19del) or L858R substitution mutations in the Phase 3 MARIPOSA study. At a median follow-up of 37.8 months, RYBREVANT^® plus LAZCLUZE^® showed a statistically significant reduction in the risk of death compared to osimertinib (hazard ratio [HR], 0.75; 95 percent confidence interval [CI], 0.61-0.92, P=0.0048). Median OS was not yet reached with the combination (95 percent CI, 42.9-not estimable) and the OS benefit is projected to exceed four years, which is at least one year beyond the median of three years observed with osimertinib (36.7 months; 95 percent CI, 33.4-41.0).⁶

“The combination of RYBREVANT plus LAZCLUZE changes the biology of the disease by preventing resistance and delivers unmatched overall survival in the first-line setting, while omitting chemotherapy from treatment,” said Danny Nguyen, M.D., Assistant Clinical Professor, Department of Medical Oncology & Therapeutics Research, City of Hope, and principal investigator for the PALOMA-3 and MARIPOSA studies.^† “Now, with the approval of RYBREVANT FASPRO, we have an entirely new subcutaneous therapy that offers consistent results compared to intravenous delivery, while providing a more patient-centered experience.”

“The approval of RYBREVANT FASPRO is a pivotal step forward, as EGFR+ NSCLC patients have previously faced limited treatment options,” explains Biljana Naumovic, President, Solid Tumor, Johnson & Johnson Innovative Medicine. “Now, patients are gaining greater access to this transformative treatment, as well as the tools needed to proactively manage common dermatological effects.”

Lower rates of ARRs (13 percent vs. 66 percent) were observed with RYBREVANT FASPRO™ compared to IV administration. The incidence of ARRs leading to interruption of any study treatment was also substantially lower in the RYBREVANT FASPRO™ and LAZCLUZE^® arm (1.0 percent). When treated with RYBREVANT FASPRO™ plus LAZCLUZE^® and prophylactic anticoagulant use (n=164), a VTE rate of 7 percent was observed, representing a return to baseline risk for patients with advanced NSCLC. Rates of VTE were lower (11 percent vs. 18 percent) in all patients treated with RYBREVANT FASPRO™ plus with LAZCLUZE^®, compared to patients treated with IV administration.¹

Overall, the safety profile of RYBREVANT FASPRO™ was largely consistent with the known profile of IV administration, and in combination with LAZCLUZE^®. The most common adverse reactions of RYBREVANT FASPRO™ in combination with LAZCLUZE^® (≥ 20 percent) were rash, nail toxicity, musculoskeletal pain, edema, fatigue, nausea, hemorrhage, peripheral neuropathy, decreased appetite, constipation, diarrhea, pruritus, and dry skin.¹

Access to RYBREVANT FASPRO™
Johnson & Johnson offers comprehensive access and support information and resources to assist patients in gaining access to RYBREVANT FASPRO™. Our patient support program, RYBREVANT withMe^‡, is available to provide personalized support to help patients start and stay on their Johnson & Johnson medicines. RYBREVANT withMe helps providers support their patients by verifying patients’ insurance coverage, providing information on Prior Authorization and Appeals processes and educating on reimbursement processes. Patients can connect to RYBREVANT withMe to receive cost support, regardless of insurance type, free, personalized one-on-one support from a Care Navigator, and resources and community connections. Learn more at RYBREVANTwithMe.com or by calling 833-JNJ-wMe1 (833-565-9631).

About the PALOMA-3 Study
PALOMA-3 (NCT05388669), which enrolled 418 patients, is a randomized, open-label Phase 3 study evaluating the PK, efficacy and safety of RYBREVANT FASPRO™ (administered via manual injection) plus LAZCLUZE^® compared to RYBREVANT^®-based regimens and LAZCLUZE^® in patients with EGFR-mutated advanced or metastatic NSCLC after progression on osimertinib and chemotherapy. The co-primary PK endpoints of the study were trough concentration [C_trough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUC_D1-D15)]. Key secondary endpoints were ORR and PFS. OS was a predefined exploratory endpoint. Prophylactic anticoagulation was recommended for the first four months of treatment.⁸

About the MARIPOSA Study

MARIPOSA (NCT04487080), which enrolled 1,074 patients, is a randomized, Phase 3 study evaluating RYBREVANT^® plus LAZCLUZE^® versus osimertinib and versus LAZCLUZE^® alone in first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or substitution mutations. The primary endpoint of the study is PFS (using RECIST v1.1 guidelines) as assessed by Blinded Independent Central Review (BICR). Secondary endpoints include OS, ORR, DoR, progression-free survival after first subsequent therapy (PFS2) and intracranial PFS.⁹

Resistance to third-generation TKIs, such as osimertinib (when given alone or with chemotherapy), remains a major barrier to long-term disease control.¹⁰ The combination regimen RYBREVANT^® plus LAZCLUZE^® uses a triple mode of action: targeting EGFR mutations from two angles, blocking MET, and engaging the immune system.⁶ This approach has the potential to change the natural history of the disease by reducing the spectrum and complexity of acquired resistance mechanisms.¹²

A new analysis from MARIPOSA, presented at the International Association for the Study of Lung Cancer (IASLC) 2025 World Congress on Lung Cancer (WCLC), demonstrated that the combination significantly reduced the development of EGFR– and MET-driven resistance compared with osimertinib in the first-line setting. MET amplifications occurred in three percent of patients on the combination vs 13 percent on osimertinib (P=0.002), and secondary EGFR mutations (such as C797S) were significantly lower for RYBREVANT^® plus LAZCLUZE^® (1 percent vs 8 percent; P=0.01). Notably, acquired MET amplification led to early discontinuation in 23 percent of patients on osimertinib within six months, compared with four percent on RYBREVANT^® plus LAZCLUZE^®.^10,11

About RYBREVANT^®
RYBREVANT^® (amivantamab-vmjw) is a first-in-class, fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity.

Data across multiple Phase 3 studies, including MARIPOSA and PALOMA-3, have demonstrated the clinical benefit of RYBREVANT^® -based regimens in improving PFS and OS in advanced EGFR-mutated NSCLC.

RYBREVANT^® is approved in the U.S. across four indications in EGFR-mutated NSCLC, including two in the first-line setting and two in the second-line, or patients with either exon 19 deletions, exon 21 L858R mutations, or exon 20 insertion mutations, as monotherapy or in combination with lazertinib or chemotherapy.

The National Comprehensive Cancer Network^® (NCCN^®) Clinical Practice Guidelines in Oncology (NCCN Guidelines^®)^§[1] include amivantamab-vmjw (RYBREVANT^®) across multiple treatment settings, including its recent inclusion as a NCCN Category 1 preferred option when used with lazertinib (LAZCLUZE^®) for first-line treatment of people with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations; see the latest NCCN Guidelines^® for NSCLC for complete information.^‖¶

The NCCN Guidelines for Central Nervous System Cancers also identify amivantamab-vmjw (RYBREVANT^®)-based regimens, including the combination with lazertinib (LAZCLUZE^®), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.^‖¶

RYBREVANT FASPRO™ is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE^® drug delivery technology.

For more information, visit: https://www.RYBREVANT.com.

About LAZCLUZE
^®

In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE^® (marketed as LECLAZA in South Korea). LAZCLUZE^® is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. An analysis of the efficacy and safety of LAZCLUZE^® from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology in 2023.

About Non-Small Cell Lung Cancer (NSCLC)
Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.^13,14 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.¹⁴ Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.¹⁵ EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.^15,16,17,18 EGFR exon 19 deletions or EGFR L858R mutations are the most common EGFR mutations.^19,20 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent.²¹ EGFR exon 20 insertion mutations are the third most prevalent activating EGFR mutation.²² Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of eight percent in the frontline setting, which is worse than patients with EGFR exon 19 deletions or L858R mutations, who have a real-world five-year OS of 19 percent. ²⁰

About EGFR Mutations
Epidermal growth factor receptor (EGFR) mutations are among the most common oncogenic drivers in NSCLC, especially in, younger individuals and those who have never smoked. These mutations promote uncontrolled cell growth and are linked to poor outcomes.¹⁸ Despite progress with targeted therapies, including third-generation EGFR tyrosine kinase inhibitors (TKI), long-term survival remains limited, with five-year survival rates below 20 percent.²¹ Overcoming resistance mechanisms, such as MET amplification and secondary EGFR mutations, is essential for improving outcomes and extending survival in EGFR-mutated NSCLC.¹⁰

INDICATIONS

RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) and RYBREVANT^® (amivantamab-vmjw) are indicated:

• in combination with LAZCLUZE^® (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
• in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
• in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.
• as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

RYBREVANT FASPRO™ is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO™ 

RYBREVANT FASPRO™ can cause hypersensitivity and administration-related reactions (ARRs); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.

RYBREVANT FASPRO™ with LAZCLUZE^®

In PALOMA-3 (n=206), all Grade ARRs occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARRs, 89% occurred with the initial dose (Week 1, Day 1).

Premedicate with antihistamines, antipyretics, and glucocorticoids and administer
RYBREVANT FASPRO™ as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO™ injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO™ based on severity.

Infusion-Related Reactions with RYBREVANT

^®

RYBREVANT^® can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.

RYBREVANT
^®
with LAZCLUZE
^®

In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT^® in 4.5% of patients.

RYBREVANT
^®
with Carboplatin and Pemetrexed

Based on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT^® in 2.8% of patients.

RYBREVANT
^®
as a Single Agent

In CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT^® in 1.3% of patients.

Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT^® as recommended. Administer RYBREVANT^® via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT^® based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT^®.

Interstitial Lung Disease/Pneumonitis

RYBREVANT FASPRO™ and RYBREVANT^® can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.

RYBREVANT FASPRO™ with LAZCLUZE^®

In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued
RYBREVANT FASPRO™ and LAZCLUZE^® due to ILD/pneumonitis.

RYBREVANT
^®
with LAZCLUZE
^®

In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT^® and LAZCLUZE^® due to ILD/pneumonitis.

RYBREVANT
^®
with Carboplatin and Pemetrexed

Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT^® due to ILD/pneumonitis.

RYBREVANT
^®
as a Single Agent

In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT^® due to ILD/pneumonitis.

Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO™ or RYBREVANT^® and LAZCLUZE^® (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.

Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE

^®

RYBREVANT FASPRO™ and RYBREVANT^® in combination with LAZCLUZE^® can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.

RYBREVANT FASPRO™ with LAZCLUZE^®

In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO™ and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).

RYBREVANT

^® with LAZCLUZE
^®

In MARIPOSA, VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT^®, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE^®; 1% of patients had VTE leading to dose reductions of RYBREVANT^®, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE^®; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT^®, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE^®. The median time to onset of VTEs was 84 days (range: 6 to 777).

Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.

Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO™ or RYBREVANT^® and LAZCLUZE^® based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO™ or RYBREVANT^® and LAZCLUZE^® at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO™ or RYBREVANT^®. Treatment can continue with LAZCLUZE^® at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE^® Prescribing Information for recommended LAZCLUZE^® dosage modification.

Dermatologic Adverse Reactions

RYBREVANT FASPRO™ and RYBREVANT^® can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.

RYBREVANT FASPRO™ with LAZCLUZE^®

In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and
RYBREVANT FASPRO™ was permanently discontinued due to rash in 1.5% of patients.

RYBREVANT
^®
with LAZCLUZE
^®

In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT^® and 30% for LAZCLUZE^®, rash leading to dose reductions occurred in 23% of patients for RYBREVANT^® and 19% for LAZCLUZE^®, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT^® and 1.7% for LAZCLUZE^®.

RYBREVANT
^®
with Carboplatin and Pemetrexed

Based on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT^® and 3.1% discontinued pemetrexed.

RYBREVANT
^®
as a Single Agent

In CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%).

When initiating treatment with RYBREVANT FASPRO™ or RYBREVANT^®, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.

If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO™ or RYBREVANT^® in combination with LAZCLUZE^®, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO™ or RYBREVANT^® as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT^® based on severity.

Ocular Toxicity

RYBREVANT FASPRO™ and RYBREVANT^® can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.

RYBREVANT FASPRO™ with LAZCLUZE^®

In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.

RYBREVANT
^®
with LAZCLUZE
^®

In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients. Withhold, reduce the dose, or permanently discontinue RYBREVANT^® and continue LAZCLUZE^® based on severity.

RYBREVANT
^®
with Carboplatin and Pemetrexed

Based on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.

RYBREVANT
^®
as a Single Agent

In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.

Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT^® based on severity.

Embryo-Fetal Toxicity

Based on animal models, RYBREVANT FASPRO™, RYBREVANT^® and LAZCLUZE^® can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO™ and RYBREVANT^®. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO™ or RYBREVANT^®, and for 3 weeks after the last dose of LAZCLUZE^®.

ADVERSE REACTIONS

RYBREVANT FASPRO™ withLAZCLUZE^®

In PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%).

Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO™, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).

RYBREVANT
^® withLAZCLUZE^®

In MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT^®) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).

Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT^®) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).

RYBREVANT
^®
 with Carboplatin and Pemetrexed

In MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).

In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).

In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).

In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.

RYBREVANT
^®
 as a Single Agent

In CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).

Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.

LAZCLUZE

^®

DRUG INTERACTIONS

Avoid concomitant use of LAZCLUZE^® with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.

Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.

Please see full Prescribing Information for

RYBREVANT FASPRO™
,

RYBREVANT^®

and

LAZCLUZE^®

.

cp-491009v1

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and Janssen Scientific Affairs, LLC are Johnson & Johnson companies.

Cautions Concerning Forward-Looking Statements 

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT^®-based regimens. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at

www.sec.gov

,

www.jnj.com

or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

cp-536497

FOOTNOTES

^* Joelle Fathi has not been paid for any media work. 

^† Dr. Nguyen has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 

^‡ The patient support and resources provided by J&J withMe are not intended to provide medical advice, replace a treatment plan from the patient’s doctor or nurse, provide case management services, or serve as a reason to prescribe a Johnson & Johnson medicine.

^§ The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

^‖ See the NCCN Guidelines for detailed recommendations, including other treatment options.

^¶ The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.

References

1. RYBREVANT FASPRO™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
2. George S, et al. Systematic literature review of intravenous versus subcutaneous administration of oncology therapies: A clinical, economic and patient perspective. Cancer Treatment Reviews. 2025 Sep; 139(102974):1-13.
3. Bittner B, et al. Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities. BioDrugs. 2018 Oct;32(5):425-440.
4. Aguiar-Ibáñez R, et al. Differences Between Intravenous and Subcutaneous Modes of Administration in Oncology from the Patient, Healthcare Provider, and Healthcare System Perspectives: A Systematic Review. Adv Ther. 2024 Dec;41(12):4396-4417.
5. Epstein R S, et al. Cancer patients’ perspectives: A qualitative study of reasons for subcutaneous preference vs intravenous treatment. Abstract presented at: 2025 ASCO Annual Meeting; May 28, 2025; Chicago.
6. Yang J, et al. Amivantamab Plus Lazertinib vs Osimertinib in First-line EGFR-mutant Advanced NSCLC – Final Overall Survival from MARIPOSA [ELCC abstract #40]. Presented at: 2025 European Lung Cancer Congress (ELCC); March 26-29, 2025; Paris, France.
7. Leighl N, et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J Clin Oncol. 2024 Oct 20;42(30):3593-3605.
8. ClinicalTrials.gov. A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3). Accessed July 2025. https://www.clinicaltrials.gov/study/NCT05388669
9. ClinicalTrials.gov. A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA). Accessed July 2025. https://classic.clinicaltrials.gov/ct2/show/NCT04487080
10. Hayashi H, et al. Mechanisms of Acquired Resistance to First-Line Amivantamab Plus Lazertinib Vs Osimertinib: Updated Analysis from MARIPOSA [IASLC abstract PT1.03.06]. Presented at: IASLC 2025 World Lung Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain.
11. Hayashi H, et al. Mechanisms of Acquired Resistance to First-Line Amivantamab Plus Lazertinib Vs Osimertinib: Updated Analysis from MARIPOSA. Poster presented at: IASLC 2025 World Conference on Lung Cancer (WCLC); September 6-9, 2025; Barcelona, Spain.
12. Oxnard GR, Lo PC, Nishino M, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013;8(2):179-184. doi:10.1097/JTO.0b013e3182779d18
13. The World Health Organization. Lung Cancer. Accessed July 2025. https://www.who.int/news-room/fact-sheets/detail/lung-cancer
14. American Cancer Society. What is Lung Cancer? Accessed July 2025. https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html
15. Melosky B, et al. Worldwide Prevalence of Epidermal Growth Factor Receptor Mutations in Non-Small Cell Lung Cancer: A Meta-Analysis. Mol Diagn Ther. 2021 Nov 23;26(1):7-18.
16. Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993.
17. Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res. 2015;5(9):2892-2911.
18. American Cancer Society. Personalized care for patients with EGFR-mutant nonsmall cell lung cancer: Navigating early to advanced disease management. Accessed November 2025. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.70024
19. American Lung Association. EGFR and Lung Cancer. Accessed July 2025. https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing
20. Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
21. Lin JJ, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65.
22. Arcila M, et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013 Feb; 12(2):220-9.

View original content:https://www.prnewswire.com/news-releases/us-fda-approval-of-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-enables-the-simplest-shortest-administration-time-for-a-first-line-combination-regimen-when-combined-with-lazcluze-lazertinib-302645263.html

SOURCE Johnson & Johnson

WASHINGTON, Dec. 17, 2025 /PRNewswire/ — American Drive Acquisition Company (the “Company”), a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses, today announced the pricing of its initial public offering of 20,000,000 units at a price of $10.00 per unit. The units are expected to be listed for trading on the Nasdaq Global Market under the ticker symbol “ADACU” beginning December 18, 2025. Each unit consists of one Class A ordinary share and one-third of one redeemable warrant of the Company. Each whole warrant entitles the holder thereof to purchase one Class A ordinary share at a price of $11.50 per share, subject to certain adjustments. Once the securities comprising the units begin separate trading, the Company expects that its Class A ordinary shares and warrants will be listed on the Nasdaq Global Market under the symbols “ADAC” and “ADACW,” respectively. The offering is expected to close on December 19, 2025, subject to customary closing conditions.

While the Company may pursue an initial business combination opportunity in any business, industry or geographic location, it intends to capitalize on the ability of its management team to identify, acquire and operate a business or businesses that can benefit from its management team’s established global relationships, sector expertise and active management and operating experience. In particular, it currently intends to focus on American companies in the defense, logistics, transportation, technology and AI sectors.

Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering. The Company has granted the underwriters a 45-day option to purchase up to 3,000,000 additional units at the initial public offering price to cover over-allotments, if any.

The public offering is being made only by means of a prospectus. When available, copies of the prospectus relating to the offering may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, New York, NY 10022, Attention: General Counsel, or by email at: [email protected].

A registration statement relating to the securities became effective on December 17, 2025. 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 any such state or jurisdiction.

Forward-Looking Statements

This press release contains statements that constitute “forward-looking statements,” including with respect to the proposed initial public offering and the anticipated use of the net proceeds from the offering. No assurance can be given that the offering discussed above will be completed on the terms described, or at all, or that the Company will ultimately complete a business combination transaction. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s registration statement and preliminary prospectus for the Company’s offering filed with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these documents are available on the SEC’s website, at www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

View original content:https://www.prnewswire.com/news-releases/american-drive-acquisition-company-announces-pricing-of-200-million-initial-public-offering-302645258.html

SOURCE American Drive Acquisition Company

TSXV: ITR; NYSE American: ITRG

www.integraresources.com

VANCOUVER, BC, Dec. 17, 2025 /PRNewswire/ – Integra Resources Corp. (“Integra” or the “Company”) (TSXV: ITR) (NYSE American: ITRG) is pleased to announce the results of its Feasibility Study (the “FS”) for the development of its wholly-owned DeLamar Gold and Silver Heap Leach Project (“DeLamar” or the “Project”), comprised of the DeLamar and Florida Mountain deposits, located in southwestern Idaho.

(All amounts in United States (“U.S.”) dollars unless otherwise stated)

2025 DeLamar Feasibility Study Highlights:

• Robust and resilient project returns: After-tax net present value 5% (“NPV”) of $774 million (“M”) and 46% after-tax internal rate of return (“IRR”) using base case metal prices of $3,000 per ounce (“/oz”) gold (“Au”) and $35/oz silver (“Ag”); After-tax NPV of $1.7 billion (“B”) and 89% after-tax IRR using spot metal prices of $4,250/oz Au and $60/oz Ag.
• Increased ounces and mine-life: Addition of stockpile material enhances mine life to 10 years and total life-of-mine (“LOM”) production to 1.1 million ounces (“Moz”) of gold equivalent (“AuEq”).
• Consistent and profitable production profile
  ^1,2,3
  : Average production of 119 thousand ounces (“koz”) AuEq from year 1 to 5 with average LOM production of 106 koz AuEq at site level cash costs of $1,179/oz AuEq (co-product) and below industry average all-in sustaining costs (“AISC”) of $1,480/oz AuEq (co-product); efficient mining supports low life-of mine strip ratio of 0.54:1.
• Realistic and financeable Project: Total initial capital cost of $389 M (includes $38 M of owners’ cost) and sustaining capital of $305 M over the LOM; strong project financing pathway created by ongoing cash flow generation from the Company’s operating Florida Canyon Mine (“Florida Canyon”) and strong cash balance of ~$81 million as at the third quarter 2025.
• Competitive Project metrics
  ⁴
  : Base case NPV-to-capex ratio of 2.0 and payback of 1.8 years; spot NPV-to-capex ratio and payback improve to 4.4 and 1.1 years, respectively.
• Strong free cash-flow profile in early years
  ²
  : Excellent profitability at beginning of mine life; Year 1-5 average after-tax free cash flow of $165 M; smooth transitioning from Florida Mountain to DeLamar deposits with no grade or tonnage “cliffs”.
• Simplified Project layout and processing: Two oxide heap leach facilities (“HLF”) (vs. single large HLF design in the 2022 Pre-Feasibility Study (“PFS”)), and two-stage crushing (vs. three-stage in PFS); reduced mine-site footprint and enhanced water usage strategy brings potential permitting advantages.
• Meaningful benefits to local communities: Excellent local support for Project development built upon years of engagement and early inclusion of local interests in Project design; an average of 300 direct permanent jobs are expected to be created at DeLamar.
• Strong Tribal partnerships: Relationship Agreement with the Shoshone-Paiute Tribes of the Duck Valley Indian Reservation (the “Shoshone-Paiute”) establishes a transformative and long-term partnership for the development of DeLamar; engagement underway with additional Tribal Nations near the Project area.
• Significant scarcity value: DeLamar remains one of the few large-scale precious metals projects in the U.S. at the Feasibility Study level that is actively being advanced toward National Environmental Protection Act (“NEPA”) federal mine permitting.
• Visibility on short and long-term growth: Large Measured and Indicated sulphide resource material excluded from mine plan with multiple-near mine expansion targets open along strike and at depth; DeLamar is one of the largest undeveloped silver resources in the U.S. with a largely underexplored district scale land package.
• Opportune timing: With the FS now complete and federal permitting expected to commence in the near term, the Project is well positioned to advance in one of the strongest gold–silver price environments in history, supported by favorable U.S. permitting tailwinds.

George Salamis, President, CEO and Director of Integra commented: “The Feasibility Study confirms what we have long believed: DeLamar is one of the most compelling, resilient, and capital-efficient heap leach gold-silver projects in the U.S. preparing to enter federal permitting. The FS outlines a simplified, phased, and materially de-risked development plan with outstanding economics, including a rapid 1.8-year payback, strong early free cash flow profile, and one of the highest NPV-to-capex ratios among projects of this scale. Importantly, the FS is being delivered as federal permitting is expected to commence in early 2026, positioning Integra to advance DeLamar at an opportune time. While the FS reflects a conservative, oxide-only development case, it represents only the beginning for DeLamar. The Project also hosts a large sulphide mineral resource that is not included in the mine plan, multiple near-mine expansion opportunities that remain open, and largely underexplored district-style upside.

The updated two heap leach configuration materially improves constructability, operating flexibility, and capital efficiency, while providing meaningful leverage to higher metal prices and maintaining resilience in lower-metal price environments. Updated feasibility-level engineering, metallurgy, and costing significantly enhance Project confidence, reduce execution risk, and support future permitting through a more advanced and robust water management strategy. The delivery of the FS is a major milestone for Integra and underscores our confidence in DeLamar’s ability to generate long-term value for our shareholders, Tribal Nation partners, and the communities of Idaho. DeLamar is expected to support an average workforce of approximately 300 high-quality, long-term jobs over the life-of-mine. We look forward to providing further permitting guidance as the Project enters a new phase in 2026.”

Integra will host a conference call and webcast to discuss the FS on Thursday, December 18, 2025 at 11:00 AM Eastern Time / 8:00 AM Pacific Time, featuring a presentation from the senior management team and a live Q&A session. A recording will be available on Integra’s corporate website. To register for the webcast, please use the following link (call details are listed below):

https://events.q4inc.com/attendee/518660974

Feasibility Study Summary

The FS confirms robust economics for a low-cost, large-scale, conventional open pit oxide heap leach operation, with competitive operating costs and high rate of return. The FS outlines total production of 1.1 Moz AuEq over a 10-year operating mine life (plus two years of residual leaching), resulting in an average annual production profile of 106 koz AuEq per annum at a co-product mine-site AISC of $1,480/oz. The Project generates an after-tax NPV5% of $774 M with an after-tax IRR of 46% at base case gold and silver prices of $3,000/oz and $35/oz, respectively.

The Company retained Forte Dynamics, Inc. (now SLR Consulting Limited) (“Forte”) as lead consultants, along with other engineering consultants, to complete the FS and prepare a technical report in accordance with National Instrument 43-101 Standards of Disclosure for Mineral Projects (“NI 43-101”). The FS is derived from updated mineral reserve estimate effective December 8, 2025. The effective date of the FS is December 8, 2025, and a technical report prepared in accordance with NI 43-101 will be filed on the Corporation’s website and under its SEDAR+ profile within 45 days of this news release.

Table 1: DeLamar Feasibility Study Highlights¹

Figure 1:


DeLamar Project


Production and Operating Cost Profile^1,2

Figure 2:


DeLamar Project


After-tax Cash Flow Profile (base case)^1,2

Table 2:


DeLamar Project


After-Tax NPV, IRR and Payback Sensitivity Table

Property Description, Location and Access

The historic mine site and Delamar Project are located within southwestern Idaho in Owyhee County approximately 80 air kilometers southwest of Idaho’s state capital of Boise. The nearest town is Jordan Valley, Oregon which is situated near U.S. highway 95, a 1.5 hour drive from Boise. The Project is within the historical Carson mining district and includes the formerly producing DeLamar silver-gold mine, which was last operated by Kinross Gold Corporation. The Project is accessed via 28 kilometers of existing road east from Jordan Valley, Oregon.

Figure 3:


DeLamar Project Location Map

Updated Mineral Resource Estimate

Mineral resources were re-estimated from the resource model released in 2023 which includes the Florida Mountain deposit, the DeLamar deposit, and historical stockpiles and backfill.  The mineral resource estimate is based on 3,348 drillholes totaling ~383,000 meters (“m”). Gold and silver mineralization was modeled following industry-standard and Canadian Institute of Mining, Metallurgy & Petroleum (“CIM”)-compliant protocols.

Key steps included:

• Statistical evaluation of assay data and determination of natural grade populations.
• Construction of mineral-domain wireframes using 30-meter spaced sectional control.
• Projection and slicing of domain polygons across each deposit to ensure geological continuity.
• Coding of block models with gold and silver using level-plan geometries.
• Geostatistical analysis of mineralization trends to support estimation and classification.
• Grade interpolation using inverse-distance methods into 6 × 6 × 6 m blocks at the DeLamar deposit and 6 × 8 × 8 m blocks at the Florida Mountain deposit, with domain-specific coding to constrain estimates.

The mineral resource estimate for the FS includes updated price assumptions and metallurgical recovery inputs for the pit optimization used to constrain them. Sulphide material continues to be reported in this resource mineral update, consistent with prior studies, as it continues to show potential economic extraction. Importantly, the fundamental resource methodology has not changed from the 2023 mineral resource update.

Table 3:


DeLamar Project Mineral Resources

Updated Mineral Reserve Estimate

Proven and Probable Mineral Reserves for the Project utilized the updated resource model released in 2023, which was constrained by engineered pit designs based on Lerchs–Grossmann optimization shells, with appropriate cut-off grades that reflect updated metal prices, metallurgical recoveries, geotechnical criteria, and operating cost assumptions. No changes were made to the underlying reserve methodology since the PFS released in 2022. Variations in reserves from the previous PFS study are from the updated 2023 resources (which includes the addition of historical stockpile resources), revised cost assumptions, and metallurgical recoveries. Reserves have been updated for heap leach only material to streamline permitting, simplify processing and reduce capital. This removes sulphide material from the reserve. Additionally, drill-tested historic low grade ore stockpiles included in the resource have been included in the reserve.

Table 4:


DeLamar Project Mineral Reserves

Production Profile

The contemplated operation in the FS spans 13 years, comprising one year of construction (Year -1), 10 years of active mining and gold-silver processing operations, and two years of residual leaching and nominal production.  The Project is expected to produce a total of approximately 1.1 Moz AuEq.

The first six months of the construction period focuses on establishing the Florida Mountain deposit heap leach pad, utilizing readily available historical low-grade gold-silver ore stockpile as overliner material. This material will be screened and crushed and will provide a flow channel for leachate.

This allows the stacking of fresh, higher-grade gold-silver ore from the Florida Mountain deposit and the application of leach solution to start in month seven of the construction year, unlocking the ability to produce ~7 koz AuEq in Year -1. As solution inventory builds and leach flows increase through month 20, production ramps accordingly, resulting in 119 koz AuEq produced during the first full year after construction (Year 1). The DeLamar deposit heap leach pad construction begins in Year 3 and begins to receive DeLamar deposit historic stockpile and pit ore in Year 4. Active mining operations will continue until Year 10 followed by two years of residual gold-silver leaching.

Figure 4:


DeLamar Project


Production Breakdown by Area

Figure 5:


DeLamar Project


Production Breakdown by Metal

Mining

Mining is designed as a conventional open-pit operation using truck-and-shovel methods, focused on delivering high grade gold-equivalent production from the Florida Mountain deposit early in the Project, before transitioning to sustained mid-life production at the DeLamar deposit. The mine plan schedules 185 million tonnes (“Mt”) of total material movement over the 10-year active mine life, including 120 Mt of ore with an average grade of 0.33 g/t Au and 13.6 g/t Ag, for a combined 1.3 Moz of contained gold and 52.3 Moz of contained silver. Strip ratios remain low and consistent at 0.54:1 over the life-of-mine, supporting efficient mining and strong early cash flows. Mining rates of ore are planned for 35,000 tonnes per day (“tpd”) with no more than 12 benches extracted per year.

Material movement is sequenced to prioritize higher-grade Florida Mountain deposit ore in the first four years, enabling average production of ~119 koz AuEq per year during the payback window. Mid-life mining transitions to the DeLamar deposit pit, which provides consistent tonnage, stable grades, and reduced haulage requirements as backfill is incorporated into the sequencing.

Mining assumptions are built from first principles, including drill penetration rates, powder factors, cycle times, equipment availabilities, and original equipment manufacturer (“OEM”)-validated haulage models. The fleet includes up to 17 haul trucks, three production drills, and a matched loading fleet of excavators and shovels sized to maintain efficient dig-and-haul cycles. Waste placement and backfilling strategies minimize external dump requirements and align with closure objectives. Overall, the mining plan reflects an executable, low-risk approach that supports strong economics, operational flexibility, and a smooth transition into reclamation activities in the later years of the Project.

Figure 6:


DeLamar Project


Mining Profile

Processing and Recovery

Project mineralization is amenable to conventional cyanide leaching. The Project has an updated two heap leach configuration that considers environmental, heap stability, and economic impacts. This configuration balances early capital efficiency with operational flexibility, allowing staged commissioning while managing particle fines and agglomeration risk across distinct ore domains. To reduce truck haulage requirements, one heap leach pad will be located adjacent to the Florida Mountain deposit, and the other will be located adjacent to the DeLamar deposit.

Run-of-mine ore will be transferred from the pits via haul trucks to their respective heaps leach pads for two-stage crushing before stacking.  The crushing circuit consists of a primary mineral sizer and secondary low-pressure roll crusher, reducing the particle size of run of mine ore to a P80 (particle size at which 80% of the sample material passes) of approximately 19 millimeters. The selection of crushing equipment was supported by abrasion and impact testing.

The crushed ore from the Florida Mountain deposit contains limited fines and does not require agglomeration, making it suitable for direct truck dump stacking following two-stage crushing.

A portion of the crushed ore from the DeLamar deposit pit contains enough fines and clay and will require agglomeration through a screening and agglomeration circuit followed by curing and conveyor stacking. Screening and selective agglomeration are applied only where required, minimizing operating complexity while protecting permeability and recovery performance.

Heaps leach pads will be stacked at a rate of 35,000 tpd. Cyanide solution will be applied and processed via a small Merrill-Crowe facility located near the DeLamar deposit heap leach pad, designed for a throughput of approximately 1,360 m³ per hour. Filter cakes will be further processed at Integra’s Florida Canyon Mine refinery to produce doré bars, reducing initial capital requirements for DeLamar. Florida Canyon is expected to have sufficient permitted capacity to process DeLamar doré without modification.

Figure 7:


DeLamar Project


Heap Leach Stacking by Source

Table 5: DeLamar Project Mining & Processing Summary

Power and Infrastructure

The Project infrastructure strategy prioritizes refurbishment and targeted upgrades to minimize initial capital, while maintaining reliability and certainty around the construction schedule.

DeLamar historically operated as a fully serviced site until 1998 after which limited remediation and ongoing care and maintenance were completed. Several existing facilities and infrastructure elements remain in place and will be refurbished or augmented for the new Project. New infrastructure will be constructed only where required to meet capacity, safety, or operational performance requirements of the Project.

The Project will require up to 6.5 megawatts (“MW”) of power which will be supplied to the site by the refurbished 69-kilovolt (“kV”) transmission line and distributed throughout the site via a new substation and refurbished 4,160 power distribution network.  A 2 MW backup generator is planned to be installed for back-up or emergency power.

The existing water treatment plant will be upgraded and augmented with more treatment capacity for use in the Project.

On-site facilities will be selectively upgraded to align with the planned mining fleet and operation profile. The existing five-bay mobile maintenance shop will be upgraded to six-bays, large enough to accommodate 150-tonne series haul trucks. The administration building will be repaired, and site communications infrastructure will be enhanced. Existing site roads will be refurbished and upgraded limiting the need for new roads.

A small Merrill-Crowe plant will be constructed with ditches and ponds to capture contact water for treatment and industrial use. Additional new construction includes a two-stage crushing circuit, truck wash, laboratory, and warehouse.

Operating Costs

Operating costs were estimated through first principles and supplier quotes. Where possible, first principal assumptions and costs of units were compared to those experienced at the Florida Canyon Mine, Integra’s active heap leach operation in Nevada.

Mining operating cost estimates were prepared by RESPEC Company LLC (“RESPEC”) using first principles. This was done using estimated hourly costs of equipment and personnel against the anticipated hours of work for each. The equipment hourly costs were estimated for fuel, oil and lubrication, tires, under-carriage, repair and maintenance costs, and special wear items. First principal assumptions and the cost of mine personnel and consumables were benchmarked against Florida Canyon.

Process operating costs were developed by Forte from first principles to determine unit consumptions of materials, supplies, power and personnel, and the estimated cost of unit for these was estimated from supplier quotes and industry benchmarks. The cost of materials, supplies, power and labor were benchmarked against Florida Canyon.

Labor general and administrative (“G&A”) costs were estimated based on personnel requirements for administrative, accounting, safety and security, and environmental departments to support mining and processing activities.  Costs are also included for legal, land, permit bonding and power. G&A costs were benchmarked against Florida Canyon.

Table 6:


DeLamar Project


Operating and Mining Cost Breakdown

Project Royalties

The FS considers two primary royalties that apply to the Project. Triple Flag Precious Metals Corp. (“Triple Flag”) holds a 2.5% net smelter returns royalty (“NSR”) that applies to ~90% of the current DeLamar deposit resources and reserves, however the royalty will be reduced to 1.0% upon Triple Flag receiving total royalty payments of C$10 M. A wholly-owned subsidiary of Wheaton Precious Metals Corp. currently holds a 1.5% NSR that applies to the current DeLamar and Florida Mountain deposit resources and reserves. The production profile in the FS reflects an average royalty rate of 2.3%.

Capital Cost Estimates

Capital cost estimates emphasize constructability, vendor-supported pricing, and execution sequencing aligned with the planned development schedule.

Mining initial and sustaining capital estimates were prepared by RESPEC.  Estimates assume owner-operated mining equipment and are based on the equipment and facilities required to achieve the production schedule.  Capital costs are based on estimation guides, quotations from equipment vendors and recent costs for new equipment at the Company’s operating Florida Canyon mine in Nevada. 

The process and infrastructure capital costs were developed by Forte for initial and sustaining capital. The capital costs for each phase are comprised of direct costs and indirect costs. The direct costs were developed from labor, materials, plant equipment, sub-contracts, and construction equipment.  Indirect costs were applied to the direct costs to account for items such as: construction support, engineering, procurement and construction management, vendor support during specialty construction and commissioning, spare parts, contingency, owner’s costs, freight and taxes. Capital costs were estimated based on 2025 U.S. dollars and are presented with no added escalation.

Table 7:


DeLamar Project


Capital Cost Breakdown

Environmental and Permitting

The Project is supported by strong environmental and technical teams that have led major advancements in obtaining necessary approvals and permits since the 2022 PFS, including the Mine Plan of Operations completeness determination by the U.S. Bureau of Land Management (“BLM”) and the completion of environmental resource baseline studies to support Project environmental effects analysis under NEPA.   Integra has an established collaborative approach with regulatory agencies and our technical teams and will continue to develop the Project to meet all applicable regulatory standards. The construction and operation of the Project require further permitting which will continue to actively advance in 2026 and 2027 through parallel U.S. Federal, State of Idaho, and Owyhee County permitting processes that address mine reclamation, air and water quality, wetland impacts and cyanidation.

In accordance with the BLM’s mandate to prevent undue environmental degradation on public lands, the Project design optimization has continued to focus on the reduction of environmental impacts and surface disturbance of the mine operation through a leaching-focused process, consolidation of development rock storage facilities and the design of heap leach facilities in proximity to the open pits. Through various studies conducted on the Project over the years, the proposed mine footprint has been reduced by ~25%. This optimization will continue through the evaluation of agency-proposed alternatives and mitigations during the NEPA process to deliver a robust mine operation that is protective of water resources, air quality, cultural resources, wildlife and vegetation, and post-mine land use.

Stakeholder, Community, and Tribal Nation Engagement

Since Project acquisition in the third quarter of 2017, the Company has operated with dedicated budget and personnel to engage proactively with the communities, Tribal Nations, and other stakeholders with ties to DeLamar. With increasing frequency as the Project approaches state and federal permitting, the Company has worked to build lasting relationships with a wide range of stakeholders, including nearby residents and community members, Tribal Nations, nongovernmental organizations and various levels of government representatives. This approach reflects a deep Company-wide commitment to a high standard of social performance, achieved by acting transparently and building mutual respect and shared value.

Stakeholder engagement is guided by an External Stakeholder Plan (“ESP”), a Project site-specific plan that is updated annually to guide the activities, goals, and strategies for stakeholder engagement in a tailored manner that reflects the unique requirements of each region, individual stakeholder context, and cultural settings surrounding DeLamar. The ESP management approach specifically addresses the Company’s stakeholder engagement, public communication, community involvement & investment, and monitoring & reporting – including social impact risks assessments, grievance procedures, materiality, and metric tracking.

Since 2020, Integra has worked to engage proactively and respectfully with potentially affected Tribal Nations, with the intent to exceed regulatory requirements by prioritizing early, inclusive, and respectful dialogue in order to build mutual understanding and recognize Tribal interests. In 2025, Integra and the Shoshone-Paiute Tribes of the Duck Valley Indian Reservation entered into a Relationship Agreement that will guide a mutually beneficial partnership between the two parties over the course of the permitting, development, and future operation of the Project. Integra is concurrently advancing discussions with additional Tribal Nations to evaluate the interest in developing similar relationships.

Integra’s approach of being present and active within the Project’s stakeholder network has allowed the Company to build consensus and collaborate on issues of shared concern as the mine and operational designs have iteratively evolved. Potential social and community impacts have been and will continue to be considered and evaluated in accordance with the NEPA and other federal and state laws. There are no currently known social or community issues that would be expected to have a material impact on the Company’s ability to mine at the Project.

Exploration Potential and Upside at DeLamar

Beyond the FS mine plan, DeLamar offers substantial longer-term upside and strategic optionality.  The FS includes an updated mineral resource statement that includes sulphide mineral resources, which are currently excluded from the Project’s mineral reserves and economic analysis, preserving future processing and development optionality as technology, costs, and market conditions evolve. In addition, DeLamar hosts one of the largest undeveloped silver mineral resources in the U.S. and sits within a largely underexplored, district-scale land package with multiple near-mine and regional exploration targets open along strike and at depth. The Project layout and infrastructure contemplated in the FS also provide flexibility for potential future throughput expansion, allowing Integra to pursue disciplined growth opportunities while maintaining a simplified, low-risk development pathway.

Next Steps and Opportunities

With the FS complete, the Company is advancing permitting and construction readiness. Near-term priorities include advancing detailed engineering and execution planning. Opportunities remain to further optimize the production plan, mine sequence and heap leach facility design to maximize early production from the Florida Mountain deposit and further smooth the transition to DeLamar deposit production. The simplified oxide-focused Project design, combined with robust early cash flow potential and strong economics, positions DeLamar well for permitting, financing, and development execution. 

No Production Decision: The Company has not made a production decision for the Project. A decision to proceed with construction will only be made following the completion and review of detailed engineering, financing arrangements, and receipt of all required permits and approvals.

DeLamar Feasibility Study Conference Call & Webcast

Integra will host a conference call and webcast on Thursday, December 18, 2025, at 11:00 AM Eastern Time / 8:00 AM Pacific Time, to discuss the DeLamar FS. Details for the conference call and webcast are included below.

Dial-In Numbers / Webcast:

Conference ID: 8306105
Toll Free: (800) 715-9871
Toll: +1 (646) 307-1952

Webcast: https://events.q4inc.com/attendee/518660974

About Integra

Integra is a growing precious metals producer in the Great Basin of the Western United States. Integra is focused on demonstrating profitability and operational excellence at its principal operating asset, the Florida Canyon Mine, located in Nevada. In addition, Integra is committed to advancing its flagship development-stage heap leach projects: the past producing DeLamar Project located in southwestern Idaho and the Nevada North Project located in western Nevada. Integra creates sustainable value for shareholders, stakeholders, and local communities through successful mining operations, efficient project development, disciplined capital allocation, and strategic M&A, while upholding the highest industry standards for environmental, social, and governance practices.

ON BEHALF OF THE BOARD OF DIRECTORS

George Salamis
President, CEO and Director

CONTACT INFORMATION

Corporate Inquiries: [email protected]
Company website: www.integraresources.com
Office phone: 1 (604) 416-0576

Qualified Persons

The scientific and technical information contained in this news release has been reviewed and approved by James Frost, P.Eng., Director, Technical Services of Integra Resources Corp., who is a Qualified Person as defined by NI 43-101. In reviewing and approving this disclosure, Mr. Frost has relied upon the work of other Qualified Persons, each of whom has reviewed and approved the scientific and technical information within their respective areas of expertise.

Forte Dynamics, Inc. part of SLR Consulting Limited, has led the Feasibility Study and is managing the Report with RESPEC Company LLC contributing. The following independent Qualified Persons with associated firms have reviewed and approved this news release as defined by NI 43-101:

Barry Carlson, P.E., SME-RN, Forte Dynamics, Inc.
Deepak Malhotra, Phd., P.E., SME-RN, Forte Dynamics, Inc.
Jeffrey Bickel, C.P.G., RESPEC Company LLC
Keith Watson, P.Eng., RESPEC Company LLC
Jay Nopola, P.E., RESPEC Company LLC

Data Verification

The Qualified Persons responsible for the FS technical report have verified the data for which they are accountable, including the sampling, analytical, and test data underlying the information disclosed in this news release. Geological, mine engineering and metallurgical reviews included, among other things, reviewing drill data and core logs, review of geotechnical and hydrological studies, environmental and community factors, the development of the life of mine plan, capital and operating costs, transportation, taxation and royalties, and review of existing metallurgical test work. In the opinion of the Qualified Persons, the data, assumptions, and parameters used in the sections of the FS that they are responsible for preparing are sufficiently reliable for those purposes. The technical report in respect of the FS, when filed, will contain more detailed information concerning individual Qualified Persons responsibilities, associated quality assurance and quality control, and other data verification matters, and the key assumptions, parameters and methods used by the Company.

Sampling and QA/QC Procedure

Thorough QA/QC protocols are followed on the Project, including insertion of duplicate, blank and standard samples in the assay stream for all drill holes. The samples are submitted directly to American Assay Labs in Reno, Nevada for preparation and analysis. Analysis of gold is performed using fire assay method with atomic absorption (AA) finish on a 1 assay ton aliquot. Gold results over 5 g/t are re-run using a gravimetric finish. Silver analysis is performed using ICP for results up to 100 g/t on a 5-acid digestion, with a fire assay, gravimetric finish for results over 100 g/t silver.

Additional supporting details regarding the information in this news release, will be provided in the FS technical report which will be available on SEDAR+ under the Company’s profile within 45 days of this news release, including all qualifications, assumptions and exclusions that relate to the FS. The FS technical report is intended to be read as a whole, and sections should not be read or relied upon out of context.

Forward Looking Statements

Certain information set forth in this news release contains “forward‐looking statements” and “forward‐looking information” within the meaning of applicable Canadian securities legislation and in applicable United States securities law (referred to herein as forward‐looking statements). Forward-looking statements are often identified by the use of words such as “may”, “will”, “could”, “would”, “anticipate”, “believe”, “expect”, “intend”, “potential”, “estimate”, “budget”, “scheduled”, “plans”, “planned”, “forecasts”, “goals” and similar expressions. Except for statements of historical fact, certain information contained herein constitutes forward‐looking statements which includes, but is not limited to, statements with respect to: the future financial or operating performance of the Company, the Project and its mineral properties; results from work performed to date; the estimation of mineral resources and reserves; the realization of mineral resource and reserve estimates; the development, operational and economic results of the FS for the Project, including cash flows, revenue potential, development, expenditures, and timing thereof, extraction rates, life-of-mine projections and cost estimates; timing of completion of a technical report summarizing the results of the FS; magnitude or quality of mineral deposits; anticipated advancement of the Project mine plan; exploration expenditures, costs and timing of the development of new deposits; costs and timing of future exploration; permitting; construction and optimization planning; estimates of metallurgical recovery rates; anticipated advancement of the Project, future prospects and prospective inclusion of Mineral Resources in future mining activities; requirements for additional capital; the future price of metals; government regulation of mining operations; environmental risks; the timing and possible outcome of pending regulatory matters; the realization of the expected economics of the Project; future growth potential of the Project; and future development plans.

Forward-looking statements are based on a number of factors and assumptions made by management and considered reasonable at the time such statement was made. Assumptions and factors include: the Company’s ability to complete its planned exploration and development programs; the absence of adverse conditions at the Project and the Company’s mineral properties; satisfying ongoing covenants under the Company’s loan facilities; no unforeseen operational delays; no material delays in obtaining necessary permits; results of independent engineer technical reviews; the possibility of cost overruns and unanticipated costs and expenses; the price of gold remaining at levels that continue to render the Project and the Company’s mineral properties economic; the Company’s ability to continue raising necessary capital to finance operations; and the ability to realize on the mineral resource and reserve estimates. Forward‐looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward‐looking statements. These risks and uncertainties include, but are not limited to: general business, economic and competitive uncertainties; the actual results of current and future exploration activities; conclusions of economic evaluations; meeting various expected cost estimates; benefits of certain technology usage; changes in project parameters and/or economic assessments as plans continue to be refined; future prices of metals; possible variations of mineral grade or recovery rates; the risk that actual costs may exceed estimated costs; geological, mining and exploration technical problems; failure of plant, equipment or processes to operate as anticipated; accidents, labor disputes and other risks of the mining industry; delays in obtaining governmental approvals or financing; risks related to local communities; the speculative nature of mineral exploration and development (including the risks of obtaining necessary licenses, permits and approvals from government authorities); title to properties; and other factors beyond the Company’s control and as well as those factors included herein and elsewhere in the Company’s public disclosure. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in the forward-looking statements, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. Readers are advised to study and consider risk factors disclosed in Integra’s Annual Information Form dated March 26, 2025 for the fiscal year ended December 31, 2024, which is available on the SEDAR+ issuer profile for the Company at www.sedarplus.ca and available as Exhibit 99.1 to Integra’s Form 40-F, which is available on the EDGAR profile for the Company at www.sec.gov.

Investors are cautioned not to put undue reliance on forward-looking statements.  The forward-looking statements contained herein are made as of the date of this news release and, accordingly, are subject to change after such date.  The Company disclaims any intent or obligation to update publicly or otherwise revise any forward-looking statements or the foregoing list of assumptions or factors, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws.  Investors are urged to read the Company’s filings with Canadian securities regulatory agencies, which can be viewed online under the Company’s profile on SEDAR+ at www.sedarplus.ca.

Cautionary Note Regarding Non-GAAP Financial Measures

Alternative performance measures in this news release such as “cash cost”, “AISC” and “free cash flow” are furnished to provide additional information. These non-GAAP performance measures are included in this news release because these statistics are used as key performance measures that management uses to monitor and assess performance of DeLamar, and to plan and assess the overall effectiveness and efficiency of mining operations. These performance measures do not have a standardized meaning within International Financial Reporting Standards (“IFRS”) and, therefore, amounts presented may not be comparable to similar data presented by other mining companies. These performance measures should not be considered in isolation as a substitute for measures of performance in accordance with IFRS.

Cash Costs

Cash costs include site operating costs (mining, processing, site G&A), refinery costs and royalties, but excludes head office G&A and exploration expenses.  While there is no standardized meaning of the measure across the industry, the Company believes that this measure is useful to external users in assessing operating performance.

All-In Sustaining Cost

Site level AISC includes cash costs and sustaining and expansion capital, but excludes head office G&A and exploration expenses. The Company believes that this measure is useful to external users in assessing operating performance and the Company’s ability to generate free cash flow from potential operations.

Free Cash Flow

Free cash flows are revenues net of operating costs, royalties, capital expenditures and cash taxes. The Company believes that this measure is useful to the external users in assessing the Company’s ability to generate cash flows from the Project.

Cautionary Note for U.S. Investors Concerning Mineral Resources and Reserves

NI 43-101 is a rule of the Canadian Securities Administrators which establishes standards for all public disclosure an issuer makes of scientific and technical information concerning mineral projects. Technical disclosure contained in this news release has been prepared in accordance with NI 43-101 and the Canadian Institute of Mining, Metallurgy and Petroleum Classification System. These standards differ from the requirements of the U.S. Securities and Exchange Commission (“SEC”) and resource and reserve information contained in this news release may not be comparable to similar information disclosed by domestic United States companies subject to the SEC’s reporting and disclosure requirements.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

View original content to download multimedia:https://www.prnewswire.com/news-releases/integra-delivers-robust-feasibility-study-for-delamar-gold-silver-heap-leach-project-highlighting-improved-economics-and-reduced-development-risk-302645246.html

SOURCE Integra Resources Corp.