Posts

Posted on

Vivani Medical to Present at the Boulder Peptide Symposium

Vivani Medical to Present at the Boulder Peptide Symposium

ALAMEDA, Calif.–(BUSINESS WIRE)–
Vivani Medical, Inc. (NASDAQ: VANI) (the “Company” or “Vivani”), an innovative, preclinical-stage biopharmaceutical company that develops novel, long-term drug implants, announced today that it will present at the upcoming Annual Boulder Peptide Symposium at 11:20 am PST at the Napa Valley Marriott Hotel and Spa in Napa, California on September 19, 2023.

Dr. Adam Mendelsohn, CEO, will provide updates on the company, its proprietary NanoPortal™ implant technology and the company’s lead program, NPM-119, a miniaturized, 6-month, GLP-1 implant currently under development for the treatment of type 2 diabetes and obesity.

About Vivani Medical, Inc.

Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve tolerance to their medication. Vivani’s lead program NPM-119 is a miniaturized, 6-month GLP-1 implant under investigation for the treatment of patients with type 2 diabetes and is also under consideration for the treatment of obesity. NPM-119 is designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason why type 2 diabetes treatments face significant challenges in achieving positive real-world effectiveness.

Vivani’s wholly owned subsidiary Cortigent, formed to continue the business of Second Sight, is developing targeted neurostimulation systems intended to help patients recover critical body functions. Investigational devices include Orion®, designed to provide artificial vision to people who are profoundly blind, and a new system intended to accelerate the recovery of arm and hand function in patients who are partially paralyzed due to stroke. The company has developed, manufactured, and marketed an implantable visual prosthetic device, Argus II®, that delivered meaningful visual perception to blind individuals. Vivani continues to assess strategic options for advancing Cortigent’s pioneering technology.

Forward-Looking Statements

This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that in this press release, including statements regarding our business, products in development, including the therapeutic potential thereof, the planned development therefor, plans to address any requests from the FDA related to the agency’s clinical hold on the LIBERATE-1 trial, the initiation of LIBERATE-1 and reporting of trial results, our plans with respect to Cortigent and its proposed initial public offering, technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions. 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. Actual results and outcomes 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 actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of our products, including NPM-119; delays and changes in the development of our products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct our development activities, including our ability to address any requests from the FDA in related to LIBERATE-1 and to commence clinical development of NPM-119; risks related to the initiation, enrollment and conduct of our planned clinical trials and the results therefrom; our history of losses and our ability to access additional capital or otherwise fund our business; market conditions and the ability of Cortigent to complete its initial public offering. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company’s most recent Annual Report on Form 10-K filed with the SEC filed on March 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by us in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes 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 added information, future developments or otherwise, except as required by law.

Company Contact:

Donald Dwyer

Chief Business Officer

[email protected]

(415) 506-8462

Investor Relations Contact:

Brigid A. Makes

Chief Financial Officer

[email protected]

(415) 506-8462

Media Contact:

Sean Leous

ICR Westwicke

[email protected]

(646) 866-4012

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Neurology Biotechnology Pharmaceutical Optical Health Diabetes Medical Devices Health Technology

MEDIA:

Posted on

Procter & Gamble Brings Relief to Residents Affected by Hurricane Idalia in Florida With P&G Products and Tide Loads of Hope Laundry Services

Procter & Gamble Brings Relief to Residents Affected by Hurricane Idalia in Florida With P&G Products and Tide Loads of Hope Laundry Services

–(BUSINESS WIRE)–
The Procter & Gamble Company (NYSE:PG) :

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230907403864/en/

Tide Loads of Hope Set-Up (Photo: Business Wire)

Tide Loads of Hope Set-Up (Photo: Business Wire)

WHO:

Families, individuals and first responders in need of personal care items, cleaning products or laundry services in the wake of Hurricane Idalia.
 

WHAT:

The Tide Loads of Hope Mobile Laundry Unit, powered by Matthew 25: Ministries, has been deployed to Perry, Fla., to support relief and recovery efforts in the wake of Hurricane Idalia. The mobile laundry unit will begin services in impacted areas, providing free, full-service laundry to affected residents. Residents can bring clothes (up to two loads per household) to be washed, dried and folded, free of charge. All washable clothing types will be accepted, with the exception of heavy bedding.
 

 

In partnership with Matthew 25: Ministries, P&G will also distribute free personal care kits with everyday essentials, as well as cleaning products to meet basic hygiene and home care needs directly into impacted neighborhoods.
 

WHY:

Hurricane Idalia, a category 3 hurricane with up to 125 mph winds, made landfall in Florida’s Big Bend region, the first major hurricane to directly hit the area in more than 125 years. The hurricane brought a devastating storm surge to the area, causing major flooding and leaving hundreds of thousands without power or access to clean water.

 

 

 

P&G has a history of giving back to the communities where we live, work and serve consumers, and we want to provide everyday essentials to those who need it most to help bring a sense of normalcy in this time of need. These services are free and available to people affected by the disaster and the volunteers who are helping to respond.

 

 

WHERE:

Starting on Thursday, Sept. 7, the team will collect laundry at the below location and time until daily capacity has been reached. The team will also be distributing personal care kits and cleaning supplies directly to the affected areas.
 

 

Walmart Supercenter
 

 

1900 S. Jefferson St., Perry, FL 32348
 

 

9 am – 5 pm EDT (or until capacity is reached)
 

 

For the most up-to-date information, please visit Tide’s Twitter: @Tide and Instagram: @tidelaundry.

ABOUT TIDE LOADS OF HOPE: For more than 15 years, Tide Loads of Hope has provided free laundry services to families affected by disasters. Created in the wake of Hurricane Katrina in 2005, Tide Loads of Hope is a mobile laundromat that can complete hundreds of loads of laundry per day. In partnership with Matthew 25: Ministries, an international humanitarian aid and disaster relief organization, the program has benefitted over 90,000 people across the U.S. and Canada.

As a key component of Tide Ambition 2030, Tide has committed to expand its Loads of Hope program tenfold, providing clean clothes to millions of people in times of need, with a focus on communities most impacted by climate change. Learn more at https://tide.com/en-us/our-commitment/loads-of-hope.

PRODUCT BRANDS: P&G brands to be distributed include Always, Bounty, Charmin, Crest, Dawn, Febreze, Ivory, Gillette, Mr. Clean, Olay, Old Spice, Oral-B, Pampers, Pantene, Safeguard, Secret, Swiffer, Tampax, Tide and Venus.

PARTNER: P&G provides these services in partnership with Matthew 25: Ministries, an international humanitarian aid and disaster relief organization. More information can be found at www.m25m.org.

Media Inquiries for P&G and Tide: Anna Fobair, [email protected]

KEYWORDS: United States North America Florida Ohio

INDUSTRY KEYWORDS: Social Services Professional Services Supermarket Philanthropy Women Other Philanthropy Men Retail Family Home Goods Consumer

MEDIA:

Photo
Photo
Tide Loads of Hope Set-Up (Photo: Business Wire)
Photo
Photo
Tide Loads of Hope Truck (Photo: Business Wire)
Logo
Logo
Posted on

Rockwell Medical to Present at the H.C. Wainwright 25th Annual Global Investment Conference on Tuesday, September 12, 2023

Rockwell Medical to Present at the H.C. Wainwright 25th Annual Global Investment Conference on Tuesday, September 12, 2023

WIXOM, Mich.–(BUSINESS WIRE)–
Rockwell Medical, Inc. (the “Company”) (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that the Company’s President and CEO, Dr. Mark Strobeck, will present at the H.C. Wainwright 25th Annual Global Investment Conference on Tuesday, September 12, 2023 at 11:00 am ET at the Lotte New York Palace Hotel. More information about the conference is available at hcwevents.com/annualconference.

About Rockwell Medical

Rockwell Medical, Inc. (Nasdaq: RMTI) is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide. Rockwell Medical’s mission is to provide dialysis clinics and the patients they serve with the highest quality products supported by the best customer service in the industry. Rockwell is focused on innovative, long-term growth strategies that enhance its products, its processes, and its people, enabling the Company to deliver exceptional value to the healthcare system and provide a positive impact on the lives of hemodialysis patients. Hemodialysis is the most common form of end-stage kidney disease treatment and is typically performed at freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or in a patient’s home. Rockwell Medical’s products are vital to vulnerable patients with end-stage kidney disease, and the Company is relentless in providing unmatched reliability and customer service. Rockwell Medical is the second largest supplier of acid and bicarbonate concentrates for dialysis patients in the United States and intends to become the leading global supplier of hemodialysis concentrates. Certified as a Great Place to Work® in 2023, Rockwell Medical is Driven to Deliver Life-Sustaining Dialysis SolutionsTM. For more information, visit www.RockwellMed.com.

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as, “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,” “can,” “would,” “develop,” “plan,” “potential,” “predict,” “forecast,” “project,” “intend,” “look forward to,” “remain confident,” “are determined,” “are on track,” “are resolute in our vision,” “work to,” “drive towards,” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical’s SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to those risks more fully discussed in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2022, as such description may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law.

Heather R. Hunter

SVP, Chief Corporate Affairs Officer

(248) 432-1362

[email protected]

KEYWORDS: United States North America Michigan

INDUSTRY KEYWORDS: Biotechnology Other Manufacturing Medical Supplies General Health Health Packaging Medical Devices Manufacturing

MEDIA:

Logo
Logo
Posted on

Biodesix Announces Two Presentations on Lung Cancer Treatment Guidance Tests at the IASLC 2023 World Lung Conference on Lung Cancer

Biodesix Announces Two Presentations on Lung Cancer Treatment Guidance Tests at the IASLC 2023 World Lung Conference on Lung Cancer

New data highlights two novel proteomic tests that support treatment decision making in patients with non-small cell lung cancer (NSCLC):

  • Expanded analysis of the VeriStrat® host immune classifier’s ability to predict immune checkpoint inhibition (ICI) response in patients with advanced stage NSCLC
  • The ability of the Risk of Recurrence pipeline test to stratify time to recurrence and overall survival in patients with stage I NSCLC

BOULDER, Colo.–(BUSINESS WIRE)–
Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announced today that two abstracts will be presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Lung Conference on Lung Cancer (WCLC). The first presentation showcases a new analysis of the large multi-center observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects, NCT03289780) demonstrating the ability of the VeriStrat host immune classifier to predict response to immune checkpoint inhibitor (ICI) regimens in patients with advanced stage non-small cell lung cancer (NSCLC).

The INSIGHT trial, which recently reached its enrollment goal of 5,000 patients with NSCLC, previously yielded data showing that patients with ≥50% PD-L1 status classified as Host Immune Classifier Cold (HIC-C), also known as VeriStrat Poor, had superior median overall survival when receiving ICI plus chemotherapy versus ICI alone. The expanded analysis confirms these findings and concludes that patients with <50% PD-L1 status classified as Host Immune Classifier Hot (HIC-H), also known as VeriStrat Good, had comparable overall survival when receiving either ICI alone or in combination with chemotherapy.

“These findings highlight the importance of characterizing a patient’s immune response to lung cancer to guide immunotherapy treatment decisions,” said Wallace Akerley, MD, principal investigator of the INSIGHT study. “The growing body of evidence shows the VeriStrat test is complementary to current standard of care and its use would improve overall patient outcomes by identifying subsets of patients who would benefit from Veristrat-directed selection of immunotherapy regimen.”

The second presentation details the performance of a pre-surgical, blood-based Risk of Recurrence test in three independent cohorts. Patients with early stage lung cancer have favorable outcomes, but many of these patients experience a recurrence which results in a poor prognosis. The test was designed to identify patients with a high probability of recurrence that could be considered for more aggressive treatment or enhanced surveillance. This initial validation study evaluated nearly 800 patients with Stage I NSCLC and demonstrated the test’s ability to stratify three distinct groups of patients based on their proteomic profile with high, intermediate, or low risk of recurrence. Furthermore, incorporating the adenocarcinoma grade, a conventional risk factor for recurrence, improved the performance of the test.

“It is crucial to be able to determine which 10-15% of early stage lung cancer patients will recur within 3-5 years after their tumor is completely removed by surgery, and we are encouraged that our model, especially when incorporating the IASLC Histologic Grading System, may lead to more accuracy in this regard,” said Harvey Pass, MD lead author of the abstract. “Nevertheless, this work requires further external validation with other cohorts of Stage I lung cancer patients before it could be used clinically to determine who needs appropriate adjuvant therapy.”

Following are details about the presentations at the 2023 WCLC:

Title (P2.07-06): Real World Efficacy of First-Line Immunotherapy +/- Chemotherapy in Advanced NSCLC Stratified by Serum Proteomics

Presenter: Wallace Akerley, MD, Director of Lung Cancer Disease Center of Excellence at Huntsman Cancer Institute, University of Utah

Session P2.07: Metastatic Non-small Cell Lung Cancer – Immunotherapy – Retrospective

Date & Time: Monday, Sept. 11, 2023, 18:00 – 20:00 (SGT)

Location: Exhibit Hall, Level 4 (Row 10)

Title (P1.25-13): Enhanced Assessment of Recurrence Risk of Stage I NSCLC by Combined Adenocarcinoma Grading System and Serum Proteomic Testing

Presenter: Harvey Pass, MD, Vice Chair, Research for Cardiothoracic Surgery at NYU Langone Health, and executive committee member for the NYU Lung Cancer Center of the Perlmutter Cancer Institute

Session P1.25: Early-Stage Non-small Cell Lung Cancer – Pushing the Boundaries: Changing Paradigms and Outcomes

Date & Time: Sunday, Sept. 10, 2023, 17:30 – 19:30 (SGT)

Location: Exhibit Hall, Level 4 (Row 32)

About Biodesix

Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, visit biodesix.com.

Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions. Forward-looking statements may include information concerning the impact of the COVID-19 pandemic on Biodesix and its operations, its possible or assumed future results of operations, including descriptions of its revenues, profitability, outlook, and overall business strategy. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. The Company’s ability to continue as a going concern could cause actual results to differ materially from those contemplated in this press release and additionally, other factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Biodesix’s most recent annual report on Form 10-K, filed March 14, 2022 or subsequent quarterly reports on Form 10-Q during 2022, if applicable. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

Media:

Robbie Lunt

[email protected]

1-866-432-5930

Investors:

Chris Brinzey

[email protected]

(339) 970-2843

KEYWORDS: United States North America Colorado

INDUSTRY KEYWORDS: Biotechnology Health Oncology Clinical Trials

MEDIA:

Logo
Logo
Posted on

NanoString Expands Partnerships with Contract Research Organizations Making Spatial Molecular Imaging Tools Widely Available to Global BioPharma Researchers

NanoString Expands Partnerships with Contract Research Organizations Making Spatial Molecular Imaging Tools Widely Available to Global BioPharma Researchers

Macrogen, Inc., Propath UK, and Sirona Dx Add CosMx Spatial Molecular Imager to Meet Growing Demand for Spatial Biology Tools for Drug Developers

SEATTLE–(BUSINESS WIRE)–
NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, announced today three new Contract Research Organization (CRO) CosMxTM Spatial Molecular Imager partnerships. Macrogen, Propath UK, and Sirona Dx offer global biopharma customers new access to CosMx™ SMI technology for translational drug development. These specialty CROs provide biomarker testing services for drug developers and academic research institutions.

“NanoString is honored to partner with these leading CROs and accelerate access to spatial biology capabilities for biopharma companies around the world,” stated Brad Gray, President and CEO of NanoString. “At NanoString, we are dedicated to helping our customers advance the pace of discovery for new biological targets and new therapies for patients. These new partnerships allow us to meaningfully expand the portfolio of tools available to research scientists that can enable breakthrough achievements.”

Portland, Oregon-based Sirona Dx, one of the earliest CosMx SMI adopters, has acquired multiple systems in response to strong demand from clients. “Platform selection is one of the most important decisions to make when developing multiplexed tissue imaging panels. The ability of CosMx to interrogate both RNA and proteins at ultra-high plex with subcellular resolution is a capability our clients are incredibly eager to harness,” said Sirona Dx Chief Commercial Officer Andrew Brown, Ph.D.

Propath in Hereford, UK is among the first global CROs to offer all three NanoString platforms: nCounter® Analysis System, GeoMx® Digital Spatial Profiler and CosMx SMI. Their commitments highlight the demand for NanoString’s platforms and the importance that global biopharma customers place on having access to multiple research tool options.

“We’re excited to expand our close partnership with NanoString by being the first CRO in Europe to offer a fully managed, GCP-compliant commercial service for CosMx SMI analysis,” said Kelly Hunter, Chief Scientific Officer at Propath, UK.

Korea-based Macrogen (KOSDAQ:038290), which provides personalized healthcare services to predict and prevent diseases and provide personalized treatment options for patients, is the first CRO in the Asia-Pacific region to offer both CosMx SMI and GeoMx DSP platforms, enhancing its spatial biology research services.

About Macrogen, Inc.

About Propath

About NanoString Technologies, Inc.

NanoString Technologies, is a leader in spatial biology, offers an ecosystem of innovative discovery and translational research solutions, empowering our customers to map the universe of biology. The GeoMx® Digital Spatial Profiler is a flexible and consistent solution combining the power of whole tissue imaging with gene expression and protein data for spatial whole transcriptomics and proteomics. The CosMx™ Spatial Molecular Imager is a single-cell imaging platform powered by spatial multiomics enabling researchers to map single cells in their native environments to extract deep biological insights and novel discoveries from one experiment. The AtoMx™ Spatial Informatics Platform is a cloud-based informatics solution with advanced analytics and global collaboration capabilities, enabling powerful spatial biology insights anytime, anywhere. At the foundation of our research tools is our nCounter® Analysis System, which offers a secure way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision. For more information, visit www.nanostring.com.

The NanoString logo, NanoString, NanoString Technologies, GeoMx, CosMx and nCounter are trademarks or registered trademarks of NanoString Technologies, Inc., in the United States and/or other countries.

Doug Farrell

Vice President, Investor Relations & Corporate Communications

[email protected]

Phone: 206-602-1768

KEYWORDS: United States North America Washington

INDUSTRY KEYWORDS: Science Other Science Biotechnology Research Pharmaceutical Health Health Technology Genetics

MEDIA:

Logo
Logo
Posted on

Fennec Pharmaceuticals to Participate in Upcoming Investor Conferences

RESEARCH TRIANGLE PARK, N.C., Sept. 07, 2023 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the Company will be participating in upcoming conferences. The management team will also host one-on-one investor meetings at the conferences.

Presentation Details:

Event: H.C. Wainwright Global Investment Conference in New York City
Date: September 12, 2023
Time: Company Presentation at 1:30 PM ET

Event: Cantor Fitzgerald Global Healthcare Conference in New York City
Date: September 27, 2023
Time: Company Presentation at 3:35 PM ET

For additional information, please visit the investor relations section of the Company’s website at:
https://investors.fennecpharma.com/events-and-presentations/events

PEDMARK® (sodium thiosulfate injection)

PEDMARK® is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the only therapeutic agent with proven efficacy and safety data with an established dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

In the U.S. and Europe, it is estimated that, annually, more than 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult, and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

About Fennec Pharmaceuticals

Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK® and Pedmarqsi™ to reduce the risk of platinum-induced ototoxicity in pediatric patients. Further, PEDMARK received FDA approval in September 2022 and European Commission Marketing Authorization in June 2023 for Pedmarqsi. PEDMARK has received Orphan Drug Exclusivity in the U.S. for seven years of market protection and Pedmarqsi has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate and its use for chemoprotection, including the reduction of risk of ototoxicity induced by platinum chemotherapy, in humans. For more information, please visit www.fennecpharma.com.

Forward Looking Statements

Except for historical information described in this press release, all other statements are forward-looking. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about our business strategy, timeline, and other goals, plans and prospects, including our commercialization plans respecting PEDMARK®, the market opportunity for and market impact of PEDMARK®, its potential impact on patients and anticipated benefits associated with its use, and potential access to further funding after the date of this release. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risks and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, our ability to obtain necessary capital when needed on acceptable terms or at all, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2022. Fennec disclaims any obligation to update these forward-looking statements except as required by law.

For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.

For further information, please contact:

Investors:

Robert Andrade
Chief Financial Officer
Fennec Pharmaceuticals Inc.
(919) 246-5299

Media:

Elixir Health Public Relations
Lindsay Rocco
(862) 596-1304
[email protected]



Posted on

Opthea to Present at the H.C. Wainwright 25th Annual Global Investment Conference

MELBOURNE, Australia, Sept. 07, 2023 (GLOBE NEWSWIRE) — Opthea Limited (NASDAQ:OPT; ASX:OPT), a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, announced today that Mr. Tim Morris, the Company’s Chief Financial Officer will present at H.C. Wainwright’s 25th Annual Global Investment Conference being held at the Lotte New York Palace Hotel in New York City on September 11th – 13th, 2023.

Mr. Morris will present on Wednesday, September 13th  at 12:00PM – 12:30PM EST (2:00 AM September 14th AEDT), which can be accessed live by registering at: https://journey.ct.events/view/f538e04f-dd74-4f59-aa96-7164bf6856e6. An archive of the presentation may be accessed for 90 days on the Investors page of the Opthea website at https://ir.opthea.com/.

About Opthea Limited

Opthea (ASX:OPT; Nasdaq:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate OPT-302 is in pivotal Phase 3 clinical trials and being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone.

Inherent risks of Investment in Biotechnology Companies

There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.

Authorized for release to ASX by Megan Baldwin, CEO & Managing Director

Company & Media Enquiries:

U.S.A. & International:  Australia:
Timothy E. Morris, CFO Rudi Michelson
Opthea Limited Monsoon Communications
Tel: +1 650-400-6874 Tel: +61 (0) 3 9620 3333
   
Media:  
Hershel Berry  
Blueprint Life Science Group  
Tel: +1 415 505 3749  
[email protected]  

Join our email database to receive program updates:
Tel: +61 (0) 3 9826 0399 Email: [email protected] Web: www.opthea.com



Posted on

Aurora Mobile Launches its AI Bots Creation Platform, GPTBots

SHENZHEN, China, Sept. 07, 2023 (GLOBE NEWSWIRE) — Aurora Mobile Limited (NASDAQ: JG) (“Aurora Mobile” or the “Company”), a leading provider of customer engagement and marketing technology services in China, today announced that it successfully held the “Use AI Faster” seminar at the Hong Kong University of Science School of Business and Management on September 5, 2023. Members of the Legislative Council of the Hong Kong Special Administrative Region (HKSAR), Dr. Wendy Hong (Election Committee constituency) and Mr. Duncan Chiu (Technology and Innovation Functional constituency), Secretary for Innovation, Technology and Industry of Hong Kong, Professor Dong Sun, Chairman and Chief Executive Officer (CEO) of Aurora Mobile, Mr. Weidong Luo, and Board Advisor of the Company’s new AI product GPTBots, Mr. Tony Leung and other representatives from government, enterprises, investors, industry experts and users attended this seminar to share their insights and experiences on AI application.

Mr. Weidong Luo, Chairman and CEO of the Company, said that as ChatGPT has opened the door to infinite possibilities, Hong Kong enterprises need to quickly introduce “enterprise-level” technologies to employees, customers, and partners to create new products and markets leveraging automated redundant communication and data processing to improve user experience. This initiative aligns closely with the launch of the Company’s first AI bots creation platform GPTBots in the Asia-Pacific region. With GPTBots, enterprise users can build, train, and deploy AI bots to handle specific tasks within their business environment in about an hour without any programming experience. Using a simple user interface and just a few clicks, they can easily, economically, and efficiently create their own ‘ChatGPT’ catered specifically for the various scenarios needed within their business.

Regarding the technology of GPTBots, Board Advisor Mr. Tony Leung said, “GPTBots is a complementary general-purpose LLM AI bot featuring private data input and continuous fine-tuning, which can replace ‘rule-based’ chatbots, improve user experience, and reduce costs. GPTBots aims to provide users with an end-to-end business platform that can seamlessly integrate robots into existing applications and workflows via plug-ins.”

During the seminar, representatives from investment, accounting, education, logistics, insurance, communication, writing, legal, e-commerce, and other industries shared their valuable experiences and positive feedback from early trials of GPTBots in AI bot creation.

With its commitment to accelerate AI adoption, GPTBots aims to be a transformative force for industries with the nature and strength of “Using AI Faster”.

About GPTBots

GPTBots seamlessly connects LLMs with enterprise data and service capabilities to efficiently build AI bot services. Whether it’s a large commercial model or an open-source model, GPTBots can quickly generate the data needed to fine-tune the model and doesn’t require enterprises to invest heavily in LLM deployment, fine-tuning and other work. This new product not only supports various types of knowledge data in scenarios such as websites, Q&A, Excel, PPT, PDF, videos, databases and knowledge graphs, but also provides solutions to solve the needs of specific fields through plug-ins. Meanwhile, developers can use Flow Bot to implement visual workflows for multiple LLMs to solve complex problems. In addition, its bot training mode also supports summarizing, induction and classification of user problems, helping developers to optimize and supplement relevant knowledge to achieve better responses.

About Aurora Mobile Limited

Founded in 2011, Aurora Mobile (NASDAQ: JG) is a leading provider of customer engagement and marketing technology services in China. Since its inception, Aurora Mobile has focused on providing stable and efficient messaging services to enterprises and has grown to be a leading mobile messaging service provider with its first-mover advantage. With the increasing demand for customer reach and marketing growth, Aurora Mobile has developed forward-looking solutions such as Cloud Messaging and Cloud Marketing to help enterprises achieve omnichannel customer reach and interaction, as well as artificial intelligence and big data-driven marketing technology solutions to help enterprises’ digital transformation.

For more information, please visit https://ir.jiguang.cn/.

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Among other things, the Business Outlook and quotations from management in this announcement, as well as Aurora Mobile’s strategic and operational plans, contain forward-looking statements. Aurora Mobile may also make written or oral forward-looking statements in its reports to the U.S. Securities and Exchange Commission, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including but not limited to statements about Aurora Mobile’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: Aurora Mobile’s strategies; Aurora Mobile’s future business development, financial condition and results of operations; Aurora Mobile’s ability to attract and retain customers; its ability to develop and effectively market data solutions, and penetrate the existing market for developer services; its ability to transition to the new advertising-driven SAAS business model; its ability to maintain or enhance its brand; the competition with current or future competitors; its ability to continue to gain access to mobile data in the future; the laws and regulations relating to data privacy and protection; general economic and business conditions globally and in China and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks is included in the Company’s filings with the Securities and Exchange Commission. All information provided in this press release and in the attachments is as of the date of the press release, and Aurora Mobile undertakes no duty to update such information, except as required under applicable law.

For more information, please contact:

Aurora Mobile Limited
E-mail: [email protected]

Christensen

In China
Mr. Eric Yuan
Phone: +86-10-5900-1548
E-mail: [email protected]

In US
Ms. Linda Bergkamp
Phone: +1-480-614-3004
Email: [email protected] 



Posted on

Magna to Hold Virtual Investor Event, Updates 2025 Outlook

  • Company to present its unique market position and progress on its Go-Forward Strategy
  • Well positioned for transforming industry and growth in addressable markets
  • Updated 2025 outlook reflects active safety acquisition

AURORA, Ontario, Sept. 07, 2023 (GLOBE NEWSWIRE) — Magna International Inc. (TSX: MG, NYSE: MGA), a mobility technology company and global leader in the automotive industry, will hold a virtual investor event today. Magna’s Chief Executive Officer, Swamy Kotagiri and Chief Financial Officer, Pat McCann will present on the company’s unique position in the market, systems-level capabilities and Go-Forward Strategy to power profitable growth.   

“We are excited to update investors on our strategic progress and the tremendous opportunities we see in the transforming industry where our addressable markets continue to grow,” said Swamy Kotagiri, Magna CEO.  

The presentation and question and answer session will run from 9:00 a.m. to 10:30 a.m. ET. To view the webcast, participants can register by clicking here. The live stream will begin at 9:00 a.m. ET.

To ask a question during the question & answer session, please dial:

RESERVATION # 22027877
Toll-Free France: 0-800-913-554 Toll-Free Germany: 0-800-180-0036
Toll Switzerland: 0-800-836-320 Toll-Free United Kingdom: 0-800-528-2796
Toll-Free North America: 1-800-768-8804 Toll International: 1-303-223-0118
REBROADCAST INFORMATION
Replay available 2 hours after event until September 21, 2023
North America: 1-800-558-5253 International: 1-416-626-4100




2025 OUTLOOK

Our 2025 Outlook below has been updated solely to reflect the acquisition of Veoneer Active Safety. All other 2025 assumptions and financial information are unchanged from our 2025 Outlook previously provided in our press release dated February 10, 2023.

2025 Outlook Assumptions

     
Current
 		 
Previous
Light Vehicle Production (millions of units)      
North America 16.5   16.5
Europe 17.5   17.5
China 29.0   29.0
           
Average Foreign exchange rates:          
1 Canadian dollar equals     US$0.750   US$0.750
1 euro equals     US$1.070   US$1.070
           

2025 Updated Outlook

     
Current
 		 
Previous
Segment Sales          
Body Exteriors & Structures     $20.0 – $21.0 billion   $20.0 – $21.0 billion
Power & Vision     $16.8 – $17.4 billion   $14.8 – $15.4 billion
Seating Systems     $6.2 – $6.6 billion   $6.2 – $6.6 billion
Complete Vehicles     $4.0 – $4.5 billion   $4.0 – $4.5 billion
Total Sales     $46.7 – $49.2 billion   $44.7 – $47.2 billion
           
Adjusted EBIT Margin(1)     6.7% – 7.8%   6.7% – 7.8%
           
Notes:
(1) Adjusted EBIT Margin is the ratio of Adjusted EBIT to Total Sales
 

Our Outlook is intended to provide information about management’s current expectations and plans and may not be appropriate for other purposes. Although considered reasonable by Magna as of the date of this document, the 2025 Outlook above and the underlying assumptions may prove to be inaccurate. Accordingly, our actual results could differ materially from our expectations as set forth herein. The risks identified in the “Forward-Looking Statements” section below represent the primary factors which we believe could cause actual results to differ materially from our expectations.

Certain of the forward-looking financial measures above are provided on a Non-GAAP basis. We do not provide a reconciliation of such forward-looking measures to the most directly comparable financial measures calculated and presented in accordance with U.S. GAAP. To do so would be potentially misleading and not practical given the difficulty of projecting items that are not reflective of on-going operations in any future period. The magnitude of these items, however, may be significant.

This press release together with our Management’s Discussion and Analysis of Results of Operations and Financial Position and our Interim Financial Statements are available in the Investor Relations section of our website at www.magna.com/company/investors and filed electronically through the System for Electronic Document Analysis and Retrieval (SEDAR) which can be accessed at www.sedar.com as well as on the United States Securities and Exchange Commission’s Electronic Data Gathering, Analysis and Retrieval System (EDGAR), which can be accessed at www.sec.gov.

INVESTOR CONTACT
Louis Tonelli, Vice-President, Investor Relations
[email protected], 905-726-7035

MEDIA CONTACT
Tracy Fuerst, Vice-President, Corporate Communications & PR
[email protected], 248-761-7004

WEBCAST CONTACT
Nancy Hansford, Executive Assistant, Investor Relations
[email protected], 905-726-7108

OUR BUSINESS (2)
Magna is more than one of the world’s largest suppliers in the automotive space. We are a mobility technology company built to innovate, with a global, entrepreneurial-minded team of over 174,000(3) employees across 351 manufacturing operations and 103 product development, engineering and sales centres spanning 30 countries. With 65+ years of expertise, our ecosystem of interconnected products combined with our complete vehicle expertise uniquely positions us to advance mobility in an expanded transportation landscape.

For further information about Magna (NYSE:MGA; TSX:MG), please visit www.magna.com or follow us on social.

(
2
)
  Manufacturing operations, product development, engineering and sales centres include certain operations accounted for under the equity method.
(3)  Number of employees includes approximately 162,000 employees at our wholly owned or controlled entities and over 12,000 employees at certain operations accounted for under the equity method.

FORWARD-LOOKING STATEMENTS

Certain statements in this press release constitute “forward-looking information” or “forward-looking statements” (collectively, “forward-looking statements”). Any such forward-looking statements are intended to provide information about management’s current expectations and plans and may not be appropriate for other purposes. Forward-looking statements may include financial and other projections, as well as statements regarding our future plans, strategic objectives or economic performance, or the assumptions underlying any of the foregoing, and other statements that are not recitations of historical fact. We use words such as “may”, “would”, “could”, “should”, “will”, “likely”, “expect”, “anticipate”, “believe”, “intend”, “plan”, “aim”, “forecast”, “outlook”, “project”, “estimate”, “target” and similar expressions suggesting future outcomes or events to identify forward-looking statements. The following table identifies the material forward-looking statements contained in this document, together with the material potential risks that we currently believe could cause actual results to differ materially from such forward-looking statements. Readers should also consider all of the risk factors which follow below the table:


Material Forward-Looking Statement
Material Potential Risks Related to Applicable Forward-Looking Statement
Light Vehicle Production
  • Light vehicle sales levels
  • Supply disruptions
  • Production disruptions, including as a result of lower vehicle sales, and/or labour or other disruptions to vehicle production
  • Production allocation decisions by OEMs
Total Sales

Segment Sales
  • Lower than expected light vehicle production volumes
  • Potential supply disruptions
  • Concentration of sales with six customers
  • Shifts in market shares among vehicles or vehicle segments
  • Shifts in consumer “take rates” for products we sell
  • Relative foreign exchange rates
Adjusted EBIT Margin
  • Same risks as for Total Sales and Segment Sales above
  • Operational underperformance, product launch and/or product warranty/recall risks
  • Successful execution of critical program launches, including complete vehicle manufacturing of the Fisker Ocean SUV
  • Elevated levels of inflation
  • Higher costs incurred to mitigate the risk of supply disruptions, including: materials price increases; higher-priced substitute supplies; premium freight costs to expedite shipments; production inefficiencies due to production lines being stopped/restarted unexpectedly based on customers’ production schedules; and price increases from sub-suppliers that have been negatively impacted by production inefficiencies
  • Our ability to secure cost recoveries from customers and/or otherwise offset higher input costs
  • Price concessions
  • Commodity cost volatility
  • Scrap steel price volatility
  • Higher labour costs
  • Tax risks



Forward-looking statements are based on information currently available to us and are based on assumptions and analyses made by us in light of our experience and our perception of historical trends, current conditions and expected future developments, as well as other factors we believe are appropriate in the circumstances. While we believe we have a reasonable basis for making any such forward-looking statements, they are not a guarantee of future performance or outcomes. In addition to the factors in the table above, whether actual results and developments conform to our expectations and predictions is subject to a number of risks, assumptions and uncertainties, many of which are beyond our control, and the effects of which can be difficult to predict, including, without limitation:


Risks Related to the Automotive Industry

  • economic cyclicality;
  • regional production volume declines, including as a result of deteriorating vehicle affordability;
  • intense competition;
  • potential restrictions on free trade;
  • trade disputes/tariffs;


Customer and Supplier Related Risks

  • concentration of sales with six customers;
  • risks related to conducting business with newer OEMs with limited operating history, product maturity and warranty experience;
  • OEM consolidation and cooperation;
  • shifts in market shares among vehicles or vehicle segments;
  • shifts in consumer “take rates” for products we sell;
  • dependence on outsourcing;
  • quarterly sales fluctuations;
  • potential loss of any material purchase orders;
  • a deterioration in the financial condition of our supply base;


Manufacturing / Operational Risks

  • product and new facility launch risks, including the successful launch of critical programs such as the Fisker Ocean SUV;
  • operational underperformance;
  • supply disruptions, including with respect to semiconductor chips;
  • impact of volatile OEM vehicle production allocation decisions on the efficiency of our operations;
  • restructuring costs;
  • impairment charges;
  • labour disruptions;
  • climate change risks;
  • attraction/retention of skilled labour;


IT Security/Cybersecurity Risk

  • IT/Cybersecurity breach;
  • Product Cybersecurity breach;

Pricing Risks

  • inflationary pressures;
  • our ability to secure cost recoveries from customers and/or otherwise offset higher input costs;
  • pricing risks between time of quote and start of production;
  • price concessions;
  • commodity cost volatility;
  • declines in scrap steel/aluminum prices;


Warranty / Recall Risks

  • costs related to repair or replacement of defective products, including due to a recall;
  • warranty or recall costs that exceed warranty provision or insurance coverage limits;
  • product liability claims;


Acquisition Risks

  • competition for strategic acquisition targets;
  • inherent merger and acquisition risks;
  • acquisition integration risks;


Other Business Risks

  • risks related to conducting business through joint ventures;
  • our ability to consistently develop and commercialize innovative products or processes;
  • our changing business risk profile as a result of increased investment in electrification and active safety, including: higher R&D and engineering costs, and challenges in quoting for profitable returns on products for which we may not have significant quoting experience;
  • risks of conducting business in foreign markets;
  • fluctuations in relative currency values;
  • tax risks;
  • reduced financial flexibility as a result of an economic shock;
  • changes in credit ratings assigned to us;


Legal, Regulatory and Other Risks

  • antitrust risk;
  • legal claims and/or regulatory actions against us; and
  • changes in laws and regulations, including those related to vehicle emissions.




In evaluating forward-looking statements or forward-looking information, we caution readers not to place undue reliance on any forward-looking statement. Additionally, readers should specifically consider the various factors which could cause actual events or results to differ materially from those indicated by such forward-looking statements, including the risks, assumptions and uncertainties above which are:


  • discussed under the “Industry Trends and Risks” heading of our Management’s Discussion and Analysis; and

  • set out in our Annual Information Form filed with securities commissions in Canada, our annual report on Form 40-F filed with the United States Securities and Exchange Commission, and subsequent filings.


Readers should also consider discussion of our risk mitigation activities with respect to certain risk factors, which can be also found in our Annual Information Form.   



Posted on

Fortuna announces successful completion of process plant performance test at the Séguéla Gold Mine, Côte d´Ivoire

VANCOUVER, British Columbia, Sept. 07, 2023 (GLOBE NEWSWIRE) — Fortuna Silver Mines Inc. (NYSE: FSM) (TSX: FVI) is pleased to announce that the processing plant performance test was successfully completed at its Séguéla Mine in Côte d´Ivoire in August. The processing plant achieved designated performance criteria over the test period of 168 hours, which ultimately brings to conclusion the engineering, procurement, and construction contract with Lycopodium. During the performance test, the processing plant demonstrated the following notable design parameters at average head grades greater than 4.5 grams per tonne:

  • Crushing circuit throughput exceeding 190 tonnes per hour averaging >75% availability;
  • Milling circuit throughput exceeding 156 dry tonnes per hour averaging >94% availability;
  • Mill grind size (P80) less than 75 micron;
  • Elution strips once daily;
  • Tails solution losses as low as 0.011 parts per million; and
  • Gold recoveries between 85 to 95%.

Jorge A. Ganoza, President and CEO, commented: “The completion of the performance test closes the successful construction and commissioning phase of the Séguéla Mine. Completing this project on time and on budget during globally challenging times has been a great achievement, and we now look forward to realizing the full value of the project.”

Séguéla poured first gold on May 24, 2023 (refer to Fortuna news release dated May 25, 2023) and has since ramped up production to current levels, which are exceeding nameplate capacity. During the month of August, mill throughput averaged 172 tonnes per hour, exceeding nameplate capacity by 14 percent.

Since first gold pour, Séguéla has produced a total of 21,716 ounces of gold in doré.

Gold in doré produced:

Month Production (oz)  
May 24 – June 4,023  
July 6,008  
August 11,685   
 

Fortuna is working on updating Séguéla´s life of mine plan to include the Sunbird mineral deposit, where infill drilling was completed mid-year. The Company reiterates Séguéla´s 2023 annual production guidance of 60,000 to 75,000 ounces of gold (refer to Fortuna news release dated January 17, 2023).


Qualified Person

Eric Chapman, Senior Vice President of Technical Services of Fortuna, is a Professional Geoscientist registered with Engineers and Geoscientists British Columbia (Registration Number 36328) and a Qualified Person as defined by National Instrument 43-101- Standards of Disclosure for Mineral Projects. Mr. Chapman has reviewed and approved the scientific and technical information contained in this news release and has verified the underlying data.

About Fortuna Silver Mines Inc.
Fortuna Silver Mines Inc. is a Canadian precious metals mining company with five operating mines in Argentina, Burkina Faso, Côte d’Ivoire, Mexico, and Peru. Sustainability is integral to all our operations and relationships. We produce gold and silver and generate shared value over the long-term for our stakeholders through efficient production, environmental protection, and social responsibility. For more information, please visit our website.

ON BEHALF OF THE BOARD

Jorge A. Ganoza

President, CEO, and Director
Fortuna Silver Mines Inc.

Investor Relations:

Carlos Baca | [email protected] | www.fortunasilver.com | X | LinkedIn | YouTube

Forward looking Statements

This news release contains forward-looking statements which constitute “forward-looking information” within the meaning of applicable Canadian securities legislation and “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 (collectively, “Forward-looking Statements”). All statements included herein, other than statements of historical fact, are Forward-looking Statements and are subject to a variety of known and unknown risks and uncertainties which could cause actual events or results to differ materially from those reflected in the Forward-looking Statements. The Forward-looking Statements in this news release include, without limitation, statements about the Company’s plans for its mines and mineral properties; statements regarding the Company’s expectations for updating
Séguéla’s life of mine plan to include the Sunbird mineral deposit; estimated Séguéla production forecasts for 2023; exploration plans; the future results of exploration activities; and the Company’s business strategy, plans and outlook.
Often, but not always, these Forward-looking Statements can be identified by the use of words such as “estimated”, “potential”, “open”, “future”, “assumed”, “projected”, “used”, “detailed”, “has been”, “gain”, “planned”, “reflecting”, “will”, “anticipated”, “estimated” “containing”, “remaining”, “to be”, or statements that events, “could” or “should” occur or be achieved and similar expressions, including negative variations.

Forward-looking Statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any results, performance or achievements expressed or implied by the Forward-looking Statements. Such uncertainties and factors include, among others,
operational risks associated with mining and mineral processing; uncertainty relating to Mineral Resource and Mineral Reserve estimates; uncertainty relating to capital and operating costs, production schedules and economic returns;
uncertainties related to new mining operations and development projects, including the possibility that actual capital and operating costs and economic returns will differ significantly from those estimated for such projects prior to production
;
risks relating to the Company’s ability to replace its Mineral Reserves; risks associated with mineral exploration and project development; uncertainty relating to the repatriation of funds as a result of currency controls; environmental matters including obtaining or renewing environmental permits and potential liability claims; uncertainty relating to nature and climate conditions; risks
associated with political instability and changes to the regulations governing the Company’s business operations; changes in national and local government legislation, taxation, controls, regulations and political or economic developments in countries in which the Company does or may carry on business; risks associated with war, hostilities or other conflicts, such as the Ukrainian – Russian conflict, and the impact it may have on global economic activity; risks relating to the termination of the Company’s mining concessions in certain circumstances;
developing and maintaining relationships with local communities and stakeholders; risks associated with losing control of public perception as a result of social media and other web-based applications; potential opposition to the Company’s exploration, development and operational activities; risks related to the Company’s ability to obtain adequate financing for planned exploration and development activities; property title matters; risks relating to the integration of businesses and assets acquired by the Company; impairments;
risks associated with climate change legislation; reliance on key personnel; adequacy of insurance coverage; operational safety and security risks;
legal proceedings and potential legal proceedings;
the ability of the Company to successfully contest and revoke the resolution issued by SEMARNAT which annuls the extension of the environmental impact authorization for the San Jose Mine;
uncertainties relating to general economic conditions; risks relating to a global pandemic, which could impact the Company’s business, operations, financial condition and share price; competition; fluctuations in metal prices; risks associated with entering into commodity forward and option contracts for base metals production; fluctuations in currency exchange rates and interest rates; tax audits and reassessments; risks related to hedging; uncertainty relating to concentrate treatment charges and transportation costs; sufficiency of monies allotted by the Company for land reclamation; risks associated with dependence upon information technology systems, which are subject to disruption, damage, failure and risks with implementation and integration;
labour relations issues; as well as those factors discussed under “Risk Factors” in the Company’s Annual Information Form for the financial year ended December 31, 2022. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in Forward-looking Statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended.

Forward-looking Statements contained herein are based on the assumptions, beliefs, expectations and opinions of management, including but not limited to the accuracy of the Company’s current Mineral Resource and Mineral Reserve estimates; that the Company’s activities will be conducted in accordance with the Company’s public statements and stated goals; that there will be no material adverse change affecting the Company, its properties or its production estimates (which assume accuracy of projected ore grade, mining rates, recovery timing, and recovery rate estimates and may be impacted by unscheduled maintenance, labour and contractor availability and other operating or technical difficulties); the duration and effect of global and local inflation; geo-political uncertainties on the Company’s production, workforce, business, operations and financial condition; the expected trends in mineral prices, inflation and currency exchange rates; that the Company will be successful in challenging the annulment of the extension to the San Jose Mine environmental impact authorization; that all required approvals and permits will be obtained for the Company’s business and operations on acceptable terms; that there will be no significant disruptions affecting the Company’s operations and such other assumptions as set out herein. Forward-looking Statements are made as of the date hereof and the Company disclaims any obligation to update any Forward-looking Statements, whether as a result of new information, future events or results or otherwise, except as required by law. There can be no assurance that these Forward-looking Statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, investors should not place undue reliance on Forward-looking Statements.

Cautionary Note to United States Investors Concerning Estimates of Reserves and Resources

Reserve and resource estimates included in this news release have been prepared in accordance with National Instrument 43-101 Standards of Disclosure for Mineral Projects (“NI 43-101”) and the Canadian Institute of Mining, Metallurgy, and Petroleum Definition Standards on Mineral Resources and Mineral Reserves. NI 43-101 is a rule developed by the Canadian Securities Administrators that establishes standards for public disclosure by a Canadian company of scientific and technical information concerning mineral projects. Unless otherwise indicated, all mineral reserve and mineral resource estimates contained in the technical disclosure have been prepared in accordance with NI 43-101 and the Canadian Institute of Mining, Metallurgy and Petroleum Definition Standards on Mineral Resources and Reserves.

Canadian standards, including NI 43-101, differ significantly from the requirements of the Securities and Exchange Commission, and mineral reserve and resource information included in this news release may not be comparable to similar information disclosed by U.S. companies.