Charles River Laboratories to Present at Evercore ISI Investor Conference

Charles River Laboratories to Present at Evercore ISI Investor Conference

WILMINGTON, Mass.–(BUSINESS WIRE)–
Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it will present at the 7th Annual Evercore ISI HealthCONx Conference on Wednesday, December 4th, at 10:00 a.m. ET. Management will provide an overview of Charles River’s strategic focus, business developments, and recent trends.

A live webcast of the presentation will be available through a link that will be posted on the Investor Relations section of the Charles River website at ir.criver.com. A webcast replay will be accessible through the same website after the presentation and will remain available for at least two weeks.

About Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

Investor Relations Contact:

Todd Spencer

Corporate Vice President, Investor Relations

781.222.6455

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Biotechnology General Health Medical Devices Health Pharmaceutical

MEDIA:

Logo
Logo

Foresight, GINT and KONEC Announce Collaboration Agreement to Revolutionize Autonomous Tractors in South Korea

Initially t
he
parties will collaborate to design and commercialize autonomous tractor kits
, with
plans
to expand their offerings into semi

and fully autonomous solutions
for the automotive industry

Ness Ziona, Israel, Dec. 02, 2024 (GLOBE NEWSWIRE) — Foresight Autonomous Holdings Ltd. (Nasdaq and TASE: FRSX) (“Foresight” or the “Company”), an innovator in 3D perception systems, announced today the signing of a three-way multi-phase cooperation agreement with GINT Ltd. (“GINT”), a South Korean company specializing in automation technologies for agricultural machinery, construction equipment and automobiles, and KONEC Ltd. (“KONEC”), a leading South Korean Tier-One automotive supplier, to develop advanced 3D perception solutions for autonomous tractors and construction equipment.

In the short term, the parties will collaborate to design and commercialize autonomous tractor kits that integrate Foresight’s 3D perception capabilities, including visible-light and thermal infrared cameras. This integration aims to enhance operational safety, detection accuracy, and efficiency in GINT’s equipment, which often operates under challenging environmental conditions. Looking ahead, the parties will work together to expand their offerings into semi-autonomous and fully autonomous solutions for the automotive industry, including commercial vehicles and fleet management.

Foresight, GINT, and KONEC will negotiate a commercial agreement to jointly develop advanced 3D perception solutions for agricultural machinery and construction equipment. This collaboration will integrate Foresight’s technology into GINT’s autonomous control logic units, with KONEC leading the penetration into the agricultural, heavy equipment, passenger and commercial vehicle markets. The parties aim to finalize a commercial agreement by the end of the first quarter of 2025, paving the way for innovative advancements in agricultural technology.


About


GINT

GINT develops technology to increase efficiency and create value for traditional transportation and production equipment, including tractors, agricultural machinery, construction equipment, and automobiles. GINT offers “Pluva Auto” – South Korea’s No. 1 selling autonomous driving tractor kit. GINT’s solutions include telematic devices, electronic control units and cloud-based fleet management systems for agriculture mobility.


About KONEC

KONEC is a leading Tier-One automotive supplier that manufactures automobile parts for eco-friendly vehicles using a high-pressure die-casting process. KONEC has established a batch production system for lightweight metal raw materials, molds, castings, processing, and assembly through cooperation among its group affiliates. Major customers include Tesla, Hyundai Motor, and Kia. In addition to the existing business scope of lightweight metal body, chassis, and body parts, KONEC is venturing into new industries in line with the electrification of mobility and software advancements.


About Foresight

Foresight Autonomous Holdings Ltd. (Nasdaq and TASE: FRSX) is a technology company developing smart multi-spectral vision software solutions and cellular-based applications. Through the Company’s wholly owned subsidiaries, Foresight Automotive Ltd., Foresight Changzhou Automotive Ltd. and Eye-Net Mobile Ltd., Foresight develops both “in-line-of-sight” vision systems and “beyond-line-of-sight” accident-prevention solutions.

Foresight’s vision solutions include modules of automatic calibration and dense three-dimensional (3D) point cloud that can be applied to different markets such as automotive, defense, autonomous vehicles and heavy industrial equipment. Eye-Net Mobile’s cellular-based solution suite provides real-time pre-collision alerts to enhance road safety and situational awareness for all road users in the urban mobility environment by incorporating cutting-edge AI technology and advanced analytics.

For more information about Foresight and its wholly owned subsidiary, Foresight Automotive, visit www.foresightauto.com, follow @ForesightAuto1 on “X” (formerly Twitter), or join Foresight Automotive on LinkedIn.


Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, Foresight is using forward-looking statements in this press release when it discusses the parties’ future obligations and objectives with respect to the collaboration agreement and their aim to finalize a commercial agreement by the end of the first quarter of 2025. Because such statements deal with future events and are based on Foresight’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Foresight could differ materially from those described in or implied by the statements in this press release.

The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in Foresight’s annual report on Form 20-F for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) on March 27, 2024, and in any subsequent filings with the SEC. Except as otherwise required by law, Foresight undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Foresight is not responsible for the contents of third-party websites. 

Investor Relations Contact:

Miri Segal-Scharia
CEO
MS-IR LLC
[email protected]
917-607-8654



BriaCell Receives Green-Light from Data Safety Monitoring Board for its Phase 3 Study in Metastatic Breast Cancer


  • The Data Safety Monitoring Board (DSMB) stated no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus an immune check point inhibitor in metastatic breast cancer

  • The pivotal Phase 3 study is currently under Fast Track Designation with the Food and Drug Administration (FDA)

PHILADELPHIA and VANCOUVER, British Columbia, Dec. 02, 2024 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces that the Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor safety data of a clinical study to determine if a study should continue, be modified, or be halted early, has completed its first review of safety events in patients enrolled in BriaCell’s pivotal randomized Phase 3 study of Bria-IMT™ plus an immune checkpoint inhibitor (CPI) combination regimen (NCT06072612). The DSMB issued a statement recommending continuation of the study in metastatic breast cancer patients. BriaCell’s pivotal Phase 3 study is currently being conducted under Fast Track Designation with the Food and Drug Administration (FDA).

“We are pleased with the DSMB’s recommendation for the continuation of BriaCell’s Phase 3 study without any protocol modification as a significant milestone towards clinical advancement of our novel immunotherapy as a safe and effective treatment option for metastatic breast cancer patients,” stated Dr. William V. Williams, BriaCell’s President & CEO.

“We strongly believe in the potential of our novel immunotherapy to transform cancer care for metastatic breast cancer patients, and the positive DSMB review reinforces our confidence in the potential use of the combination regimen in metastatic breast cancer patients,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer.

About BriaCell Therapeutics Corp.

BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.

Safe Harbor

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about BriaCell’s clinical advancement of Bria-IMT™ as a safe and effective treatment option for metastatic cancer patients; the ability of Bria-IMT™ to transform cancer care in metastatic breast cancer patients; and the potential use of the combination regimen for metastatic breast cancer patients are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements, such as those are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company’s profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.

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

Contact Information

Company Contact:

William V. Williams, MD
President & CEO
1-888-485-6340
[email protected] 

Media Relations:

Jules Abraham
CORE IR
[email protected]

Investor Relations Contact:

CORE IR
[email protected]



Jeffs’ Brands: Fort Achieves Record-Breaking Sales of $1.2 Million from its Amazon Platform During Black Friday and the November 2024 Shopping Season

Tel Aviv, Israel, Dec. 02, 2024 (GLOBE NEWSWIRE) — Jeffs’ Brands Ltd (“Jeffs’ Brands” or the “Company”) (Nasdaq: JFBR, JFBRW), a data-driven e-commerce company operating on the Amazon Marketplace, today announced that its wholly owned subsidiary, Fort Products Ltd. (“Fort”), marked exceptional performance during November 2024, reaching over $1.2 million in sales from its platform on the Amazon Marketplace in the UK and Europe, according to its seller dashboard. This represents an impressive 83% growth compared to approximately $659,000 in November 2023.

Fueled by the high demand of the Black Friday shopping season and consistent customer preference for its products, November 2024 stands as the best sales month in Fort’s history since 2015.

“November is always a critical month for retail, and this year we were able to leverage the holiday shopping period to deliver record-breaking results,” said Victor Hakmon, CEO of Jeff’s Brands. “This milestone underscores Fort’s strong brand appeal and our dedication to meeting customer expectations.”

About Jeffs’ Brands Ltd

Jeffs’ Brands aims to transform the world of e-commerce by creating and acquiring products and turning them into market leaders, tapping into vast, unrealized growth potential. Through the Company’s management team’s insight into the FBA Amazon business model, it aims to use both human capability and advanced technology to take products to the next level. For more information on Jeffs’ Brands Ltd visit https://jeffsbrands.com.

Forward-Looking Statement Disclaimer

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “should,” “could,” “seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate” or other comparable terms. For example, we are using forward-looking statements when discussing the anticipated impact of Fort’s record-breaking sales during Black Friday and November 2024 and the continued growth of its brand appeal. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to adapt to significant future alterations in Amazon’s policies; our ability to sell our existing products and grow our brands and product offerings, including by acquiring new brands; our ability to meet our expectations regarding the revenue growth and the demand for e-commerce; the overall global economic environment; the impact of competition and new e-commerce technologies; general market, political and economic conditions in the countries in which we operate; projected capital expenditures and liquidity; the impact of possible changes in Amazon’s policies and terms of use; the impact of the conditions in Israel, including the recent attacks by Hamas, Iran, and other terrorist organizations; and the other risks and uncertainties described in the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (“SEC”), on April 1, 2024 and our other filings with the SEC. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Relations Contact:

Michal Efraty
Adi and Michal PR- IR
Investor Relations, Israel
[email protected]



Osisko Provides Select Asset Updates

MONTRÉAL, Dec. 02, 2024 (GLOBE NEWSWIRE) — Osisko Gold Royalties Ltd (the “Company” or “Osisko”) (OR: TSX & NYSE) is pleased to provide some select asset updates. All monetary amounts included in this update are expressed in Canadian dollars, unless otherwise noted.

Jason Attew, President & CEO of Osisko commented: “As we head into the final stretch of 2024, positive progress continues to be made across Osisko’s high-quality asset base thanks to the ongoing hard work and dedication of our operating partners. These achievements continue to surface incremental value for Osisko and its shareholders, largely by underpinning the Company’s near-to-medium-term gold equivalent ounce delivery growth profile. Osisko’s projected growth trajectory remains peer-leading and comes from assets that require no contingent capital along the way; in other words, our five-year growth outlook is already entirely bought and paid for.”

SELECT ASSET UPDATES

Mantos Blancos (operated by Capstone Copper Corp.)

On October 31st, 2024, Capstone Copper Corp. (“Capstone”) provided an update on its Mantos Blancos mine located in the Antofagasta Region of Chile. In July 2024, a successful two-week planned shutdown was completed which included the installation of a new holding tank and additional pumps in the tailings area. These investments addressed the deficiencies identified that were preventing the sustained achievement of the 20,000 tonnes per day (“tpd”) throughput capacity from the plant’s sulphide concentrator. Following the plant ramp-up period in August, Capstone reported that ore throughput averaged 18,062 tpd through to the end of the third quarter of 2024, with plant throughput meeting or exceeding the nameplate capacity of 20,000 tpd over 23 separate operating days (as at September 30th, 2024). Capstone subsequently reported that the average daily throughput at Mantos Blancos for October 2024 was 18,481 tpd and that from November 1st to November 16th, 2024, plant throughput averaged over and above 20,000 tpd. The overall variability of the milling process has been significantly reduced and consistently higher throughput is expected throughout the fourth quarter of 2024, and beyond.

Additionally, Capstone continues to highlight the potential for a Phase II expansion at Mantos Blancos over the next few years, with a Feasibility Study, looking at increasing throughput to at least 27,000 tpd, expected towards the end of 2025.

Osisko, through its wholly-owned subsidiary Osisko Bermuda Limited (“Osisko Bermuda”), owns a silver stream on Mantos Blancos. Under the stream agreement, Osisko Bermuda will purchase 100% of payable silver produced at Mantos Blancos until 19.3 million ounces have been delivered and 40% of payable silver thereafter for the remaining life-of-mine (“LOM”).

Island Gold District (operated by Alamos Gold Inc.)

On September 12th, 2024, Alamos Gold Inc. (“Alamos”) provided updated three-year production and operating guidance incorporating the recently completed acquisition of the Magino mine and mill (“Magino”), now part of Alamos’ Island Gold District. Alamos is spending US$40 million to expand the newly acquired Magino mill to 12,400 tpd by 2026. This will accommodate ore from both Magino and the increased production from the Island Gold Mine (“Island Gold”) following the completion of the Island Gold Phase 3+ Expansion in the first half of 2026. The Phase 3+ Expansion includes a new shaft which is expected to increase underground production from Island Gold to at least 2,400 tpd. On November 4th, 2024, Alamos announced that it expects to conclude an Island Gold District LOM plan by mid-2025, followed by an Island Gold District Expansion Study by the fourth quarter of 2025.

Alamos is also now considering a further expansion of the Island Gold District in the future that would potentially increase production from the underground operation, over and above the Phase 3+ Expansion already underway. According to Alamos, a further expansion of the Magino mill to 15,000 to 20,000 tpd will be evaluated, including possibly increasing underground throughput sourced from Island Gold beyond the currently planned 2,400 tpd.

Finally, the union of Island Gold and Magino will continue to facilitate previously impossible exploration initiatives, whereby Alamos sees potential to expand the Magino open pit to the east, which was previously constrained by the boundary between the two separately owned properties; drilling is already underway.

Osisko owns a 1.38-3.0% net smelter return (“NSR”) royalty on the Island Gold Mine. With the district now fully consolidated, Alamos’ expanded and accelerated Phase 3+ Expansion mine plan at Island Gold is anticipated to transition a greater proportion of production towards Osisko’s 2% and 3% NSR royalty boundaries earlier in the mine plan, as opposed to the mineral inventory covered by Osisko’s current 1.38% NSR royalty. A small portion of the eastern limit of the Magino pit is also covered by the 3.0% NSR royalty owned by Osisko.

Éléonore Mine (operated by Newmont Corp.)

On November 25th, 2024, Newmont Corp. (“Newmont”) announced that it has agreed to sell its Éléonore operation in Northern Quebec, Canada, to Dhilmar Ltd (“Dhilmar”) for US$795 million in cash consideration. The transaction is expected to close in the first quarter of 2025, subject to certain conditions being satisfied. Dhilmar is a newly incorporated, UK-based private mining company. The company is led by its CEO and Managing Director, Alexander Ramlie, and supported by board members with decades of mining experience across a range of commodities and with both surface and underground operations. Mr. Ramlie and his team worked closely with Newmont in 2016 to acquire the Batu Hijau copper-gold mine in Indonesia on behalf of PT Amman Mineral Internasional Tbk.

Osisko has a 2.2-3.5% NSR royalty on Éléonore, with a sliding scale based on production. The royalty starts at 2.0% for the first 3.0 million ounces of gold and increases by 0.25% per million ounces produced thereafter. If the spot gold price exceeds US$500 per ounce, the rate is multiplied by 1.1. The maximum rate is capped at 3.5%. As at October 31st, 2024, Éléonore has produced over 2.46 million ounces of gold, resulting in a current NSR royalty rate of 2.2%.

Seabee Mine (operated by SSR Mining Inc.)

On November 6th, 2024, SSR Mining Inc. (“SSR Mining”) announced that gold production from Seabee was 10,252 ounces in the third quarter of 2024, reflecting the temporary suspension of operations at Seabee due to forest fires. Following the temporary suspension, employees were cleared to return to the site on September 23rd, 2024 to begin repairs to ancillary equipment damaged by the fires, including power poles, piping, and exploration equipment. Operations at Seabee were fully reinstated on October 11, 2024. As a result, full-year 2024 production guidance for Seabee is now 65,000 to 70,000 ounces of gold (previously 75,000 to 85,000 ounces of gold).

Osisko owns a 3.0% NSR royalty on Seabee, including the Santoy, Porky, and Shane exploration targets.

Namdini Gold Mine (operated by Cardinal Namdini Mining Ltd., a majority-owned subsidiary of Shandong Gold Mining Co Ltd.)

On November 8th, 2024, Cardinal Namdini Mining Ltd. (“Cardinal Namdini”) hosted a commissioning ceremony for the Namdini Gold Mine in Ghana. Cardinal Namdini reiterated that it is committed to becoming a leader in sustainable mining. The event was honoured by the presence of the many esteemed guests including: H.E. Nana Addo Dankwa Akufo-Addo, President of the Republic of Ghana; H.E. Tong Defa, Ambassador Extraordinary & Plenipotentiary of the People’s Republic of China to Ghana; Mr. Han Yaodong, CEO of Shandong Gold Group; Kugbilsong Nanlebeglang, Paramount Chief of the Talensi Traditional Area; and, Hon. Samuel A. Jinapor, Ghana Minister for Lands & Natural Resources. Subsequent to the commissioning update, news of first gold being poured at Namdini was announced on November 11th, 2024.

Namdini has been developed as a single open-pit mine feeding a conventional carbon-in-leach processing facility, with mining expected to initially focus on a high-grade starter pit area towards the north of the deposit.

Osisko owns a 1.0% NSR covering the Namdini Gold Mine.

Dalgaranga Project (operated by Spartan Resources Ltd.)

On November 25th, 2024, Spartan Resources Ltd. (”Spartan”) announced that it has received approvals from both the Department of Energy, Mines, Industry Regulation and Safety and the Department of Water and Environment Regulation for the mining and processing of underground ores at the Dalgaranga Gold Project (“Dalgaranga”), along with modifications to the mill. These approvals were an important step towards the restart of Spartan’s 100%-owned Dalgaranga project following the receipt of all key regulatory approvals required to allow the mining and processing of underground ores to proceed.

On November 27th, 2024, Spartan also announced that recent surface drilling has confirmed a significant new gold discovery, named “Freak”, immediately south (110 meters) of the Pepper Gold Deposit at Dalgaranga. Highlight intercepts included 5.37 grams per tonne (“g/t”) gold (“Au”) over 10.26 meters (”m”), and 5.30 g/t Au over 7.43 m, amongst others. Follow-up wedge holes from the parent discovery hole have now returned multiple high-grade intercepts in the new mineralized position, which remains open down-plunge, sits in a similar orientation to the Pepper and Never Never Gold Deposits and exhibits identical alteration styles and mineralogy to the first two breakthrough high-grade underground discoveries at Dalgaranga. This exciting new discovery, which is currently the focus of an intensive three-to-four diamond rig drilling program, represents the third significant high-grade discovery made by Spartan at Dalgaranga adjacent to the existing 2.5 million tonne per annum process plant and supporting surface infrastructure.

On September 30th, 2024, Osisko announced that it had entered into an agreement to acquire a 1.8% gross revenue royalty (“GRR”) on Dalgaranga operated by Spartan in Western Australia. The consideration to be paid by Osisko to the seller, Tembo Capital Mining Fund III, for the GRR will total US$44 million (“the Transaction”). Spartan has the ability to buy back up to 20% of the 1.8% GRR for a total of A$3.15 million until February 2027. Closing of the Transaction is subject to approval from Australia’s Foreign Investment Review Board which is expected in the fourth quarter or 2024.

Hermosa Project (operated by South32 Ltd.)

In its September 2024 Quarterly Activities Report published on October 20th, 2024, South32 Ltd. (“South32”) announced that it had invested US$124 million at Hermosa during the September 2024 quarter. South32 progressed construction of the Taylor zinc-lead-silver project (“Taylor”), as well as on an exploration decline for the Clark battery-grade manganese deposit. All critical path dewatering wells were also commissioned during the period.

Construction of Taylor continues to progress as planned. The headframe for the main shaft has been completed and commissioning of the hoisting system for the ventilation shaft is underway. Shaft sinking is on track to commence in the December 2024 quarter. South32 is expecting to spend US$530 million at Taylor in its fiscal year 2025. Taylor has an initial 28-year LOM based on current Mineral Reserves, with the potential to realize further exploration upside, and first production is still on schedule for South32’s fiscal year 2027.

Osisko owns a 1.0% NSR royalty on zinc and lead sulphide ores produced at Taylor / Hermosa.

Wharekirauponga Project (operated by OceanaGold Ltd.)

On October 6th, 2024, OceanaGold Ltd. (“OceanaGold”) announced that it welcomed the inclusion of its Waihi North Project, which includes the Wharekirauponga (“WKP”) proposed underground mine, in the list of proposed projects under the New Zealand Government’s Fast-track Approvals Bill for regionally and nationally significant infrastructure and development projects. The Fast-track Approvals Bill is expected to be passed into law later this year, allowing listed projects to apply directly to a government-appointed expert panel for a final decision.

On November 14th, OceanaGold also reported exploration results from drilling at WKP, located ~10 km from its operating Waihi gold mine, where highlights included 34.7 g/t Au over 4.2 m (true width), 16.8 g/t Au over 5.7 m, and 13.0 g/t Au over 6.6 m. In addition, OceanaGold noted that it is planning to release a Pre-Feasibility Study for the Waihi North Project (which includes WKP), and its existing Waihi operation on December 11th, 2024.

Osisko owns a 2.0% NSR royalty on WKP.

Windfall Project (operated by Gold Fields Limited)

On October 28th, 2024, Gold Fields Limited (“Gold Fields”) announced the completion of the acquisition of Osisko Mining Inc. following receipt of all regulatory approvals and support from shareholders for the transaction at the Osisko Mining Inc. shareholder meeting on October 17th, 2024. At the time, Gold Fields CEO Mike Fraser commented:

“Deposits of the scale and quality of Windfall with highly prospective exploration camps are rare, particularly in a world-class jurisdiction like Québec, Canada. This transaction therefore marks an important step in our journey to continue improving the quality of our portfolio. The key members of the Windfall team are remaining with the project, and we look forward to working with them and our Windfall business partners to develop this truly exceptional asset. We are also looking forward to partnering with our host communities, the Cree First Nation of Waswanipi and the city of Lebel-sur-Quévillon, other local communities, and the Québec Government to build the next major mining complex in Québec.”

Osisko owns a 2.0-3.0% NSR royalty on the Windfall Project and surrounding property.

Cariboo Project (operated by Osisko Development Corp.)

On October 14th, 2024, Osisko Development Corp. (“Osisko Development”) announced the successful closing of a non-brokered private placement of units of the company for aggregate gross proceeds of US$34.5 million. Following this, and on November 12th, 2024, Osisko Development announced the closing of an additional brokered private placement of units of the company for aggregate gross proceeds of US$57.5 million.

Separately, and on November 20th, 2024, Osisko Development announced the approval of the British Columbia (“BC”) Mines Act permits for its 100%-owned Cariboo Gold Project (“Cariboo“) located in central BC, Canada. The approval of these permits marks an important milestone in enabling Osisko Development to move forward with the construction and operation of the underground Cariboo Gold Project, in parallel with Osisko Development’s ongoing discussions and consultations with the Xatśūll First Nation. A decision for the remaining Environmental Management Act permits referred to the Statutory Decision Maker of the Ministry of Energy and Climate Solutions is expected shortly.

Progress continues on the ongoing bulk sample and underground development alongside the optimized Cariboo feasibility study work, which are slated to be completed in the first quarter of 2025 and second quarter of 2025, respectively. A formal positive final investment decision and the engagement on a project financing package in the coming months would allow for full-scale construction to commence in the second half of 2025 with a targeted completion date at the end of 2027.

Osisko owns a 5.0% NSR royalty on the Cariboo property.

Altar (operated by Aldebaran Resources Inc.)

On November 25th, 2024, Aldebaran Resources Inc. (“Aldebaran”) announced the results of an updated Mineral Resource Estimate (“MRE”) for Altar. This updated MRE includes three main porphyry discoveries (Altar Central, Altar East, and Altar United) reported within a single conceptual open pit. Highlights included a Measured & Indicated Mineral Resource of 2.40 billion tonnes grading 0.42% copper (“Cu”), 0.07 g/t Au, 1.22 g/t silver (“Ag”) and 42 parts per million (“ppm”) molybdenum (“Mo”), and an Inferred Mineral Resource of 1.22 billion tonnes grading 0.37% Cu, 0.04 g/t Au, 1.25 g/t Ag and 45 ppm Mo.

Previous to this, and on November 7th, 2024, Aldebaran announced that it had entered into an option to joint venture agreement with Nuton Holdings Ltd. (“Nuton”), a Rio Tinto venture, whereby Nuton can acquire a 20% indirect interest in the Altar copper-gold project (“Altar”) in San Juan, Argentina, by making staged payments totaling US$250 Million.

Osisko owns a 1.0% NSR royalty on the majority of Altar.

ADDITIONAL PORTFOLIO UPDATES

1) On November 29th, 2024, Osisko received its first Tocantinzinho (“TZ”) royalty payment from G Mining Ventures Corp. (“G Mining”). This was after G Mining achieved commercial production at TZ on September 1st, 2024, and also announced the production of 22,071 ounces of gold, as well as 17,144 ounces sold, during the third quarter ending September 30th, 2024. (0.75% NSR royalty)

2) Eldorado Gold Corp. announced that at Lamaque, the inaugural reserve at Ormaque is expected to be announced by the end of 2024, and material for the bulk sample is now being stockpiled in preparation for processing through the mill in December 2024. (1.0% NSR royalty, including Ormaque)

3) Minera Alamos Inc. (“Minera Alamos”) announced that at its operating Santana Gold Mine, mining and stacking operations during the first full quarter (third quarter of 2024) of production from the new Nicho Main Zone pit reached 3,800 ounces of gold which is in line with Minera Alamos’ forecasts for the period, and an amount that surpasses the total ounces mined and stacked for the entirety of 2023. (3.0% NSR royalty)

4) Marimaca Copper Corp. (“Marimaca”) announced a $68 million strategic investment by Assore International Holdings (“AIH”), including private placements totaling $30.3 million by AIH. Completion of the Definitive Feasibility Study for the Marimaca MOD Project remains on track for near-term delivery in the first half of 2025. (1.0% NSR royalty)

5) Calibre Mining Corp. announced revised 2024 production guidance from its Nevada Operations, including Pan, to be 34,000 to 36,000 ounces of gold vs. 40,000 to 45,000 ounces of gold, previously. (4.0% NSR royalty)

6) Falco Resources Ltd. provided a corporate update on its flagship Horne 5 Project located in Rouyn-Noranda, Québec. Following the completion of the public hearing process with the Office of Public Hearings on the Environment (“BAPE”), Falco continues to file documentation and provide responses to the BAPE, in view of the completion of its report, which is due for submission to the Minister of the Environment, the Fight Against Climate Change, Wildlife and Parks by December 26, 2024. (90-100% silver stream)

7) Talisker Resources Ltd. announced an increased financing package for its 100%-owned Bralorne Gold Project (“Bralorne”) in British Columbia; aggregate proceeds of the entire financing package increased to approximately $22.6 million, and will be used to continue advancement of Bralorne, including the transition to underground mining, and for general corporate purposes. (1.7% NSR royalty)

8) U.S. GoldMining Inc. announced an updated Mineral Resource Estimate for its 100%-owned Whistler Gold-Copper Project in Alaska, U.S.A. Highlights included Indicated Mineral Resources of 294.5 million tonnes grading 0.42 g/t Au, 0.16% Cu and 2.01 g/t Ag, and Inferred Mineral Resources of 198.2 million tonnes grading 0.52 g/t Au, 0.07% Cu and 1.81 g/t Ag. (2.75% NSR royalty)

Qualified Person

The scientific and technical content of this news release has been reviewed and approved by Guy Desharnais, Ph.D., P.Geo., Vice President, Project Evaluation at Osisko Gold Royalties Ltd, who is a “qualified person” as defined by National Instrument 43-101 – Standards of Disclosure for Mineral Projects (“NI 43-101”).

About Osisko Gold Royalties Ltd

Osisko is an intermediate precious metal royalty company focused on the Americas that commenced activities in June 2014. Osisko holds a North American focused portfolio of over 185 royalties, streams and precious metal offtakes. Osisko’s portfolio is anchored by its cornerstone asset, a 3-5% net smelter return royalty on the Canadian Malartic Complex, which is home to one of Canada’s largest gold mines.

Osisko’s head office is located at 1100 Avenue des Canadiens-de-Montréal, Suite 300, Montréal, Québec, H3B 2S2.

For further information, please contact Osisko Gold Royalties Ltd:
Grant Moenting
Vice President, Capital Markets
Tel: (514) 940-0670 x116
Cell: (365) 275-1954
Email: [email protected]
Heather Taylor
Vice President, Sustainability and Communications
Tel: (514) 940-0670 x105
Email: [email protected]


Forward-looking Statements

Certain statements contained in this press release may be deemed “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of applicable Canadian securities legislation. Forward-looking statements are statements other than statements of historical fact, that address, without limitation, future events, management’s expectations on the growth of its asset base and expected development on time and on budget of the projects and properties underlying Osisko’s interests. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential”, “scheduled” and similar expressions or variations (including negative variations), or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors, most of which are beyond the control of Osisko, and actual results may accordingly differ materially from those in forward-looking statements. Such risk factors include, without limitation, (i) with respect to properties in which Osisko holds a royalty, stream or other interest; risks related to: (a) the operators of the properties, (b) timely development, permitting, construction, commencement of production, ramp-up (including operating and technical challenges), (c) differences in rate and timing of production from resource estimates or production forecasts by operators, (d) differences in conversion rate from resources to reserves and ability to replace resources, (e) the unfavorable outcome of any challenges or litigation relating title, permit or license, (f) hazards and uncertainty associated with the business of exploring, development and mining including, but not limited to unusual or unexpected geological and metallurgical conditions, slope failures or cave-ins, flooding and other natural disasters or civil unrest or other uninsured risks, (ii) with respect to other external factors: (a) fluctuations in the prices of the commodities that drive royalties, streams, offtakes and investments held by Osisko, (b) fluctuations in the value of the Canadian dollar relative to the U.S. dollar, (c) regulatory changes by national and local governments, including permitting and licensing regimes and taxation policies, regulations and political or economic developments in any of the countries where properties in which Osisko holds a royalty, stream or other interest are located or through which they are held, (d) continued availability of capital and financing and general economic, market or business conditions, and (e) responses of relevant governments to infectious diseases outbreaks and the effectiveness of such response and the potential impact of such outbreaks on Osisko’s business, operations and financial condition; (iii) with respect to internal factors: (a) business opportunities that may or not become available to, or are pursued by Osisko, (b) the integration of acquired assets or (c) the determination of Osisko’s PFIC status (d) that financial information may be subject to year-end adjustments. The forward-looking statements contained in this press release are based upon assumptions management believes to be reasonable, including, without limitation: the absence of significant change in Osisko’s ongoing income and assets relating to determination of its PFIC status, and the absence of any other factors that could cause actions, events or results to differ from those anticipated, estimated or intended and, with respect to properties in which Osisko holds a royalty, stream or other interest, (i) the ongoing operation of the properties by the owners or operators of such properties in a manner consistent with past practice and with public disclosure (including forecast of production), (ii) the accuracy of public statements and disclosures made by the owners or operators of such underlying properties (including expectations for the development of underlying properties that are not yet in production), (iii) no adverse development in respect of any significant property, (iv) that statements and estimates relating to mineral reserves and resources by owners and operators are accurate and (v) the implementation of an adequate plan for integration of acquired assets.

For additional information on risks, uncertainties and assumptions, please refer to the most recent Annual Information Form of Osisko filed on SEDAR+ at

www.sedarplus.ca

and EDGAR at

www.sec.gov

which also provides additional general assumptions in connection with these statements. Osisko cautions that the foregoing list of risk and uncertainties is not exhaustive. Investors and others should carefully consider the above factors as well as the uncertainties they represent and the risk they entail. Osisko believes that the assumptions reflected in those forward-looking statements are reasonable, but no assurance can be given that these expectations will prove to be accurate as actual results and prospective events could materially differ from those anticipated such the forward-looking statements and such forward-looking statements included in this press release are not guarantee of future performance and should not be unduly relied upon.

In this press release, Osisko relies on information publicly disclosed by other issuers and third parties pertaining to its assets and, therefore, assumes no liability for such third-party public disclosure.

These statements speak only as of the date of this press release. Osisko undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by applicable law.



ZETA INVESTOR NEWS: Zeta Global Holdings Investors are Notified that the Company has been Sued for Securities Fraud and are Urged to Contact BFA Law (NYSE:ZETA)

NEW YORK, Dec. 02, 2024 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Zeta Global Holdings Corp. (NYSE: ZETA) and certain of the Company’s senior executives for potential violations of the federal securities laws.

If you invested in Zeta, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/zeta-global-holdings-corp.

Investors have until January 21, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in Zeta securities.   The case is pending in the U.S. District Court for the Southern District of New York and is captioned Davoodi v. Zeta Global Holdings Corp.et al., No. 24-cv-08961.

What is the Lawsuit About?

Zeta is a cloud-based technology company that provides a marketing platform to assist marketers in acquiring customers. The complaint alleges that Zeta represented that its marketing platform was powered by the industry’s largest opted-in data set.

On November 13, 2024, prominent investment research firm Culper Research published a report titled: “Zeta Global Holdings Corp (ZETA): Shams, Scams, and Spam.” Based on Culper’s investigation that included proprietary interviews with industry experts and former Zeta employees, the research firm found that Zeta’s data set had been generated from a network of “consent farms” – i.e., sham websites designed to gather consumer data under false pretenses or awards that did not exist. Culper Research further wrote that these consent farms drove almost the entirety of Zeta’s growth over the past 2+ years, representing 56% of its Adjusted EBITDA, and could result in devastating regulatory action.

The news caused a significant decline in the price of Zeta stock. On November 13, 2024, the price of the company’s stock fell 37%, from a closing price of $28.22 per share on November 12, 2024, to $17.76 per share on November 13, 2024.

Click here for more information:

https://www.bfalaw.com/cases-investigations/zeta-global-holdings-corp

.

What Can You Do?

If you invested in Zeta you may have legal options and are encouraged to submit your information to the firm.

All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.

Submit your information by visiting:


https://www.bfalaw.com/cases-investigations/zeta-global-holdings-corp

Or contact:
Ross Shikowitz
[email protected]
212-789-3619

Why Bleichmar Fonti & Auld LLP?

Bleichmar Fonti & Auld LLP is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs’ Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.’s Board of Directors (pending court approval), as well as $420 million from Teva Pharmaceutical Ind. Ltd.

For more information about BFA and its attorneys, please visit https://www.bfalaw.com.


https://www.bfalaw.com/cases-investigations/zeta-global-holdings-corp

Attorney advertising. Past results do not guarantee future outcomes.



TD INVESTOR NEWS: TD Bank Investors are Notified that the Company has been Sued for Securities Fraud and are Urged to Contact BFA Law (NYSE:TD)

NEW YORK, Dec. 02, 2024 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against The Toronto-Dominion Bank (NYSE: TD) and certain of the Company’s senior executives for potential violations of the federal securities laws.

If you invested in TD Bank, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/the-toronto-dominion-bank.

Investors have until December 23, 2024 to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in TD Bank securities. The case is pending in the U.S. District Court for the Southern District of New York and is captioned Tiessen v. The Toronto-Dominion Bank.et al., No. 24-cv-08032.

What is the Lawsuit About?

TD Bank is the 10th largest bank in the United States. The complaint alleges that TD Bank made materially false and misleading statements about the scope of its anti-money laundering program.

On October 10, 2024, TD Bank pleaded guilty to criminal money-laundering-related charges and agreed to pay more than $3 billion in fines to the U.S. Department of Justice, the Federal Reserve, the Comptroller of the Currency, and the Treasury Department’s Financial Crimes Enforcement Network. The Comptroller of the Currency also imposed an “asset cap” that prevents TD Bank from growing any larger than its current size.

The news caused a significant decline in the price of TD Bank stock. On October 10, 2024, the price of the company’s stock fell 6.4%, from a closing price of $63.51 per share on October 9, 2024, to $59.44 per share on October 10, 2024.

Click here if you suffered losses:

https://www.bfalaw.com/cases-investigations/the-toronto-dominion-bank

.

What Can You Do?

If you invested in TD Bank you may have legal options and are encouraged to submit your information to the firm.

All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.

Submit your information by visiting:


https://www.bfalaw.com/cases-investigations/the-toronto-dominion-bank

Or contact:
Ross Shikowitz
[email protected]
212-789-3619

Why Bleichmar Fonti & Auld LLP?

Bleichmar Fonti & Auld LLP is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs’ Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.’s Board of Directors (pending court approval), as well as $420 million from Teva Pharmaceutical Ind. Ltd.

For more information about BFA and its attorneys, please visit https://www.bfalaw.com.


https://www.bfalaw.com/cases-investigations/the-toronto-dominion-bank

Attorney advertising. Past results do not guarantee future outcomes.



PACS INVESTOR NEWS: PACS Group, Inc. Investors are Notified that the Company has been Sued for Securities Fraud and are Urged to Contact BFA Law (NYSE:PACS)

NEW YORK, Dec. 02, 2024 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against PACS Group, Inc. (NYSE: PACS) and certain of the Company’s senior executives for potential violations of the federal securities laws.

If you invested in PACS, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases-investigations/pacs-group-inc.

Investors have until January 13, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 11 and 15 of the Securities Act of 1933 and Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in PACS securities. The case is pending in the U.S. District Court for the Southern District of New York and is captioned Manchin v. PACS Group, Inc., et al., No. 24-cv-08636.

What is the PACS Lawsuit About?

The Complaint alleges that PACS is one of the largest operators of skilled nursing facilities in the United States. As alleged, PACS repeatedly represented to shareholders that it possesses a winning “turnaround” strategy to make its nursing facilities profitable. However, in truth, it is alleged that PACS’s turnaround was driven by illicitly accessing Medicare benefits for thousands of patients.

On November 4, 2024, prominent investment research firm Hindenburg Research published a report titled: “PACS Group: How to Become A Billionaire In The Skilled Nursing Industry By Systematically Scamming Taxpayers.” After a 5-month investigation that included interviews with 18 former PACS employees, competitors, and an analysis of more than 900 PACS facility cost reports, Hindenburg alleged that “PACS abused a COVID-era waiver, inappropriately accessing skilled care Medicare benefits for thousands of patients across its national portfolio of facilities.” Hindenburg further estimated that “the scheme drove more than 100% of PACS’ operating and net income from 2020 – 2023, enabling PACS to IPO in early 2024 with the illusion of legitimate growth and profitability.”

On November 6, 2024, PACS then announced that it was postponing its Q3 earnings and that it had “received civil investigative demands from the federal government regarding the Company’s reimbursement and referral practices that may or may not be related to this week’s third-party report.”

The news caused a significant decline in the price of PACS stock. On November 4, 2024, the price of the company’s stock fell 27.8%, from a closing price of $42.94 per share on November 1, 2024, to $31.01 per share on November 4, 2024. On November 6, 2024, the price of the company’s stock fell 38.8%, from a closing price of $29.54 per share on November 5, 2024, to $18.09 per share on November 6, 2024.

Click here if you Suffered Losses:

https://www.bfalaw.com/cases-investigations/pacs-group-inc

.

What Can You Do?

If you invested in PACS you may have legal options and are encouraged to submit your information to the firm.

All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.

Submit your information by visiting:


https://www.bfalaw.com/cases-investigations/pacs-group-inc

Or contact:
Ross Shikowitz
[email protected]
212-789-3619

Why Bleichmar Fonti & Auld LLP?

Bleichmar Fonti & Auld LLP is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs’ Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.’s Board of Directors (pending court approval), as well as $420 million from Teva Pharmaceutical Ind. Ltd.

For more information about BFA and its attorneys, please visit https://www.bfalaw.com.


https://www.bfalaw.com/cases-investigations/pacs-group-inc

Attorney advertising. Past results do not guarantee future outcomes.



EW INVESTOR NEWS: Edwards Lifesciences Investors are Notified that the Company has been Sued for Securities Fraud and are Urged to Contact BFA Law (NYSE:EW)

NEW YORK, Dec. 02, 2024 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Edwards Lifesciences Corporation (NYSE:EW) and certain of the Company’s senior executives for potential violations of the federal securities laws.

If you invested in Edwards Lifesciences, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/edwards-lifesciences-corporation.

Investors have until December 13, 2024 to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in Edwards Lifesciences securities.   The case is pending in the U.S. District Court for the Central District of California and is captioned Patel v. Edwards Lifesciences Corporation, et al., No. 24-cv-02221.

What is the Lawsuit About?

The Complaint alleges that Edwards is an international company that researches, develops, and provides products and technologies for heart valve repair and replacement therapies, as well as critical care monitoring solutions. Edwards categorizes its therapies and technologies into four categories: Transcatheter Aortic Valve Replacement (“TAVR”), Transcatheter Mitral and Tricuspid Therapies (“TMTT”), Surgical Structural Heart therapies, and Critical Care therapies.

As alleged, Edwards consistently touted the TAVR platform, the significant unmet demand for TAVR, and the Company’s ability to capitalize on that demand by scaling its various patient activation activities.

These statements were allegedly materially false and misleading. In truth, TAVR’s demand and growth had stalled as Defendants’ patient activation activities failed to reach the perceived low-treatment-rate population and healthcare organizations prioritized other treatments over TAVR.

On July 24, 2024, Edwards slashed guidance for TAVR for fiscal 2024 and announced disappointing financial results for TAVR for fiscal 2Q 24. This is allegedly because developments in new procedures, including Defendant’s own TMTT, put significant strain on hospital structural heart teams such that they were underutilizing TAVR, despite the Company’s continued claims of a significantly undertreated patient population.

The news disclosed on July 24, 2024 caused a significant 31% decline in the price of Edwards stock, from $86.95 per share on July 24, 2024 to $59.70 per share on July 25, 2024.

Click here if you suffered losses:

https://www.bfalaw.com/cases-investigations/edwards-lifesciences-corporation

.

What Can You Do?

If you invested in Edwards Lifesciences you may have legal options and are encouraged to submit your information to the firm.

All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.

Submit your information by visiting:


https://www.bfalaw.com/cases-investigations/edwards-lifesciences-corporation

Or contact:
Ross Shikowitz
[email protected]
212-789-3619

Why Bleichmar Fonti & Auld LLP?

Bleichmar Fonti & Auld LLP is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs’ Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.’s Board of Directors (pending court approval), as well as $420 million from Teva Pharmaceutical Ind. Ltd.

For more information about BFA and its attorneys, please visit https://www.bfalaw.com.


https://www.bfalaw.com/cases-investigations/edwards-lifesciences-corporation

Attorney advertising. Past results do not guarantee future outcomes.



Revolution Medicines Provides Clinical Updates from its RAS(ON) Inhibitor Portfolio

Compelling Phase 1/1b update on RMC-6236 monotherapy in second-line metastatic pancreatic ductal adenocarcinoma supports ongoing Phase 3 RASolute 302 clinical trial

Phase 1/1b proof-of-concept for RMC-6236 monotherapy in previously treated non-small cell lung cancer supports Phase 3 RASolve 301 clinical trial expected to be initiated in Q1 2025

Favorable initial safety profile for combination of pembrolizumab with either RMC-6236 or RMC-6291 supports continued evaluation in non-small cell lung cancer

Initial antitumor activity of RMC-6236 and RMC-6291 combination in heavily pretreated colorectal cancer supports RAS(ON) inhibitor doublet treatment strategy

REDWOOD CITY, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, today announced key clinical updates from its RAS(ON) inhibitor portfolio. The data to be presented during an investor webcast today at 8:00 a.m. Eastern Time (ET) will focus on updated clinical data from the Phase 1 RMC-6236 monotherapy study in pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). In addition, new clinical data will be provided from several combination studies, including those evaluating RMC-6236 with pembrolizumab, RMC-6291 with pembrolizumab, and the first-of-its-kind RAS(ON) inhibitor doublet combination of RMC-6291 and RMC-6236.

“Our mission is to revolutionize treatment for patients with RAS-addicted cancers, and our ongoing progress is supported by the clinical milestones we continue to achieve in patients with a range of RAS mutant tumor types, stages of disease and lines of therapy,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “We’ve now reported initial clinical validation of three differentiated RAS(ON) inhibitors, shown evidence of promising initial clinical activity and tolerability profiles in patients with three common, difficult-to-treat RAS-addicted tumors, and shared growing evidence of clinical impact delivered through three potential treatment paradigms – as monotherapy, in combination with pembrolizumab, and as RAS(ON) inhibitor doublets.   With these compelling results, we are in a strong position to pursue an expansive set of late-stage development opportunities on behalf of patients with RAS-addicted cancers, beginning with the ongoing and pending pivotal trials.”


RMC-6236 Monotherapy Study


RMC-6236-001 is a multicenter, Phase 1/1b study designed to evaluate RMC-6236, a RAS(ON) multi-selective inhibitor, as monotherapy, in patients with advanced solid tumors. As of September 30, 2024, a total of 436 patients were treated across NSCLC (n=132) and PDAC and other solid tumors (n=304) cohorts. Patients were treated across a range of doses, from 10 mg to 400 mg once daily (QD).


PDAC Cohort


As an update to data reported at the EORTC-NCI-AACR (ENA) conference in October 2024, the company shared a new analysis of safety and activity data from the July 23, 2024 data cutoff date in patients with previously treated PDAC treated with a 300 mg QD dose, the same dose used in the ongoing RASolute 302 Phase 3 PDAC trial.

Key findings:

  • In 76 patients with RAS mutant PDAC, RMC-6236 at 300 mg QD was generally well tolerated and showed an overall safety profile consistent with the results reported at ENA. No differentiated safety signals were observed.
    • The most common treatment-related adverse events (TRAEs) were rash and gastrointestinal (GI)-related toxicities that were primarily Grade 1 or 2 in severity. No Grade 3 or higher TRAEs were observed in greater than 10% of patients.
    • There were no treatment discontinuations due to TRAEs and the mean dose intensity was 89%.
  • In 37 patients with 2L RAS mutant PDAC, RMC-6236 at 300 mg QD demonstrated compelling antitumor activity.
    • Patients with PDAC harboring a KRAS G12X mutation (n=22) achieved a median PFS of 8.8 months (95% confidence interval (CI), 8.5 months – not estimable (NE)), while the median OS was not estimable (95% CI, NE – NE). Patients with PDAC harboring any RAS mutation (n=37) achieved a median PFS of 8.5 months (95% CI, 5.9 months – NE), while the median OS was not estimable (95% CI, 8.5 months – NE).
    • The proportion of patients who remained alive six months after starting treatment with RMC-6236 was 100% and 97% in patients with PDAC harboring a KRAS G12X mutation and patients with PDAC harboring any RAS mutation, respectively.
    • The objective response rate (ORR) was 36% and 27% in patients with PDAC harboring a KRAS G12X mutation and patients with PDAC harboring any RAS mutation, respectively.

RASolute 302, the company’s randomized Phase 3 study of RMC-6236 versus standard of care chemotherapy in 2L patients with previously treated metastatic PDAC, is currently ongoing.

Next steps:

  • Based on the encouraging monotherapy data update, the company aims to advance RMC-6236 into earlier lines of therapy for patients with metastatic PDAC.


NSCLC Cohort


As an update from a smaller initial cohort reported at ESMO 2023, data from a September 30, 2024 data cutoff date were reported for 124 patients with previously treated RAS mutant NSCLC who received RMC-6236 at clinically active doses in the range of 120 mg to 300 mg QD.

Key findings:

  • In patients with previously treated NSCLC, RMC-6236 was generally well tolerated at doses of 120 mg to 220 mg QD, while the 300 mg QD dose demonstrated a higher frequency and severity of TRAEs.
    • In the 120 mg to 220 mg dose range, the most common TRAEs were rash and GI-related toxicities that were primarily Grade 1 or 2 in severity. No Grade 3 or higher TRAEs were observed in greater than 10% of these patients. In the 120 mg to 220 mg dose range, TRAEs leading to dose modification occurred in 41% of patients with 4% of patients discontinuing treatment due to TRAEs and the mean dose intensity was 88%.
  • RMC-6236 at 120 mg to 220 mg QD demonstrated encouraging antitumor activity in the population of 40 efficacy-evaluable 2L or third-line (3L) patients with NSCLC who had received immunotherapy and platinum chemotherapy but had not received docetaxel.
    • These patients achieved a median PFS of 9.8 months (95% CI, 6 – 12.3 months), a median OS of 17.7 months (95% CI, 13.7 months – NE) and an ORR of 38%.

Next steps:

  • The company expects to initiate RASolve 301, a randomized Phase 3 study of RMC-6236 versus docetaxel in patients with previously treated, locally advanced or metastatic RAS mutant NSCLC, in the first quarter of 2025.


RAS(ON) Inhibitor Combination Studies


RMC-6236 with Pembrolizumab


RMC-LUNG-101B is an arm of the Phase 1b study of RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with RAS mutant NSCLC. A total of 20 patients treated with RMC-6236 at 200 mg QD and pembrolizumab at the standard dose of 200 mg once every three weeks (Q3W) were evaluated as of an October 28, 2024 data cutoff date. The median duration of treatment for these patients was 2.3 months.

The combination of RMC-6236 with pembrolizumab was generally well tolerated and the safety profile was consistent with previously reported results for the individual agents. TRAEs of Grade 1 aspartate aminotransferase (AST) elevation were reported in two patients (10%) and a TRAE of Grade 2 AST elevation was reported in one patient (5%). A TRAE of Grade 1 alanine transaminase (ALT) elevation was reported in one patient (5%) and a TRAE of Grade 3 ALT elevation was reported in one patient (5%). The mean dose intensity for RMC-6236 was 97%.

Next steps:

  • The company believes the data from this study support continued evaluation of the combination of RMC-6236 with pembrolizumab in 1L NSCLC patients.


RMC-6291 and RMC-6236 RAS(ON) Inhibitor Doublet


RMC-6291-101 is a Phase 1b study of RMC-6291 in combination RMC-6236 in patients with RAS G12C mutant solid tumors. The study has evaluated RMC-6291 at doses of 100 mg or 200 mg BID and RMC-6236 at a dose range of 100 mg to 300 mg QD. As of an October 28, 2024 data cutoff date, 74 patients were evaluated for safety with a median duration of treatment of 2.3 months.

The combination of RMC-6291 with RMC-6236 was generally well tolerated across all dose levels evaluated. The most common TRAEs were rash and GI-related toxicities that were primarily Grade 1 or 2 in severity. No Grade 3 or higher TRAEs were observed in greater than 5% of patients. One Grade 4 TRAE of hypokalemia was associated with Grade 3 diarrhea. TRAEs leading to dose interruption or reduction occurred in 30% and 10% of patients, respectively. The mean dose intensities for RMC-6291 and RMC-6236 were 95% and 92%, respectively.

A subset of efficacy-evaluable patients with colorectal cancer (CRC) who were previously treated with a KRAS(OFF) G12C inhibitor was evaluated for antitumor activity on treatment with RMC-6291 with RMC-6236. As reference values, the company also reported that the ORR for patients with CRC treated with RMC-6236 monotherapy at a dose of 300 mg daily in the RMC-6236-001 study as of a data cutoff date of September 30, 2024 was 9%, and the ORR for patients with CRC previously treated with a KRAS(OFF) G12C inhibitor who were subsequently treated with RMC-6291 monotherapy at a dose of 200 mg twice daily in the RMC-6291-001 study as of a data cutoff date of October 28, 2024 was 0%. In the combination study, patients with CRC who were previously treated with a KRAS(OFF) G12C inhibitor and who received their first doses of the two study drugs at least 8 weeks prior to data cutoff were included in the analyses (n=12). The ORR was 25%, including one patient with an unconfirmed complete response, and the DCR was 92%. The median treatment duration was 2.3 months.

Next steps:

  • The company believes the data from this combination study support continued development of RAS(ON) doublets in a broad range of tumor types and earlier lines of therapy.


RMC-6291 with Pembrolizumab


RMC-LUNG-101A is an arm of the Phase 1b study of RMC-6291, a RAS(ON) G12C-selective inhibitor, in combination with pembrolizumab, with or without chemotherapy, in patients with RAS G12C mutant NSCLC. A total of 15 patients treated with RMC-6291 at 200 mg twice daily (BID) and pembrolizumab at the standard dose of 200 mg Q3W were evaluated as of an October 28, 2024 data cutoff date. As of this date, 47% of these patients had been on treatment for 60 days or more.

The combination of RMC-6291 with pembrolizumab was generally well tolerated and the safety profile was consistent with previously reported results for the individual agents. A TRAE of Grade 1 AST elevation was reported in one patient (7%) and a TRAE of Grade 1 ALT elevation was reported in one patient (7%). There were no TRAEs of Grade 2 or higher AST or ALT elevations reported. The mean dose intensity for RMC-6291 was 98%.

Next steps:

  • The company believes the three pairwise combinations of RMC-6291 with RMC-6236, RMC-6236 with pembrolizumab and RMC-6291 with pembrolizumab justify investigation of the triplet combination of RMC-6291 and RMC-6236 with pembrolizumab as a potential chemotherapy-sparing option for patients with 1L NSCLC.

Investor Webcast

The Revolution Medicines investor webcast will begin at 8:00 a.m. Eastern Time. A link to participate in the live webcast can be accessed here and is also available on the Events and Presentations section of Revolution Medicines’ investor website at https://ir.revmed.com/events-and-presentations. Following the live webcast, a replay will be available on the company’s website for at least 14 days.


About Revolution Medicines, Inc.


Revolution Medicines is a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors RMC-6236, a RAS(ON) multi-selective inhibitor, RMC-6291, a RAS(ON) G12C-selective inhibitor, and RMC-9805, a RAS(ON) G12D-selective inhibitor, are currently in clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-5127 (G12V), RMC-0708 (Q61H) and RMC-8839 (G13C), in addition to RAS companion inhibitors RMC-4630 and RMC-5552.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding expected timing and progression of clinical studies and findings from these studies, including the safety, tolerability and antitumor activity of the company’s product candidates alone or in combination with other therapies, and the durability of these results; the late-stage development opportunities the company plans to pursue; the expected timing of initiation of the company’s Phase 3 RASolve 301 clinical trial; the company’s aim to advance RMC-6236 into earlier lines of therapy for patients with PDAC; the company’s plans to develop RAS(ON) doublets in a broad range of tumor types and earlier lines of therapy; the company’s continued evaluation of the combination of RMC-6236 with pembrolizumab in 1L NSCLC patients; and the company’s plans to study the triplet combination of RMC-6291, RMC-6236 and pembrolizumab. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ current stage of development, the process of designing and conducting preclinical studies and clinical trials, risks that the results of prior clinical trials may not be predictive of future clinical trials, clinical efficacy, or other future results, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape impacting the company, and the effects on the company’s business of global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 6, 2024, and its future periodic reports to be filed with the SEC. Except as required by law, the company undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.



Investors & Media Contacts:
[email protected]
[email protected]