Day: November 27, 2024

LUND, Sweden, Nov. 27, 2024 /PRNewswire/ — 

July-September 2024

• Net sales, which for the quarter only included royalties, amounted to 235 KSEK (488).
• Net earnings amounted to -51.1 MSEK (-38.6).
• Earnings per share before and after dilution were -0.73 SEK (-0.91).
• Cash flow from operating activities amounted to -21.2 MSEK (-35.6).
• Cash and cash equivalents at end of period amounted to 54.2 MSEK (106.7)
• New lab staffed and fully operational after rapid implementation and validation was announced on July 2.
• Detailed discovery study results for the company’s next-generation early detection test for pancreatic cancer were presented at the PancreasFest 2024 Annual Meeting on July 25.
• Completion of the development of the pancreatic cancer detection test after substantially increasing test accuracy was announced on August 1.
• Filing of a US provisional patent application to protect its next-generation test was announced on August 2.
• Immunovia’s next generation test to be included in a large study of pancreatic cysts funded by the US National Institutes of Health, was announced August 5.
• On August 6 Immunovia announced final terms of rights issue and on August 12 the prospectus in connection with forthcoming rights issue was published.
• On September 2 the preliminary outcome off the rights issue was published and on September 3 the final outcome in rights issue was announced.
• On September 12 Immunovia carried out a directed issue of units to guarantors in connection with the completed rights issue.
• Data from the model development study was presented at the 2024 AACR Advances in Pancreatic Cancer medical conference, which was announced on September 16.
• On September 30 the company informed on the change in number of shares and votes in Immunovia AB.

Significant events after the period

• October 2 the company informed that the company has completed the analytical validation of its next-generation test designed to detect early-stage pancreatic cancer, which demonstrated excellent results, reinforcing the reliability and robustness of the test.
• The successful acquisition of all blood samples required to clinically validate its next-generation test for pancreatic cancer was announced on October 6.
• On the November 7 Immunovia presented an update from the model development study on its next-generation test at the annual meeting of the PRECEDE Consortium, a collaboration of 51 pancreatic centers worldwide.
• On November 15, the Company presented the model-development study results at a meeting of the Collaborative Group of the Americas—Inherited Gastrointestinal Cancers.

CEO’s comments 

ON PLAN FOR A US MARKET INTRODUCTION IN 2025

Q3 marked another quarter of strong performance as we continued to achieve our goals and deliver on milestones. As previously reported, the analytical validation proved our next-generation test to be accurate, stable and precise. The test development will culminate with the clinical validation, which will read out in Q4. Looking ahead to 2025, we will transition from focusing on research and development to commercializing the new test and generating further clinical evidence.

WE ACHIEVED OUR Q3 GOALS AND ARE MAKING EXCELLENT PROGRESS IN Q4

We closed a successful rights issue in which Investors subscribed to over 90% of the units offered, significantly exceeding expectations. This high level of participation enhances our chances for a very successful outcome for our TO2 and TO3 warrants in January and April 2025, respectively. Assuming the same level of participation in the warrants offering as in the rights issue in total would give us more than 12 months of runway and enable us to pursue our 2025 goals, outlined below.

We took important steps to validate the performance of our new test in Q3. Through the analytical validation, we have confirmed the technical performance of our next-generation test in measuring the target proteins. We also obtained blood samples from over 200 pancreatic cancer patients and more than 800 high-risk individuals for the next step: the clinical validation of the test. Securing over a thousand samples on such short timing was possible thanks to our strong relationships with experts at leading pancreatic cancer programs. We were also the first diagnostics company to receive blood samples from the PRECEDE Consortium.

Clinical validation is our key focus in Q4. The study is well underway, with our lab team in Research Triangle Park, North Carolina, analyzing hundreds of samples. We expect to complete the study and announce results in December 2024.

OUR PLAN FOR 2025 IS CLEAR AND FOCUSED

Looking forward to 2025, we will focus on the following goals:

1. Execute on a targeted introduction of the next-generation test in the US.
2. Complete additional clinical studies needed to secure reimbursement.
3. Secure a strategic partner at the appropriate time to expand commercial reach and accelerate market penetration.
4. Ensure sufficient resources for the targeted launch and additional clinical studies.

We will execute a targeted launch of the next-generation test in the second half of 2025. We expect to conduct a targeted launch of the next-generation test in the United States in the second half of 2025. The test will be launched as a lab-developed test (LDT) and all samples will be processed at our lab in Research Triangle Park, USA.

Our objective for the initial launch phase is to demonstrate physician and patient demand. The key measure of success will be test adoption and volume at targeted pancreatic centers. This will support our efforts to secure a strategic partner. It will also bolster our reimbursement efforts as payers want to see evidence that clinicians are using the test.

We expect reimbursement of the test to come in 2026 after payer review of published clinical study results. At launch, we will likely pursue a patient-pay model in which patients will be asked to pay a portion of the normal cost of the test.

Since revenue per test will be very limited in 2025, we will pursue a targeted, limited scale, cost-effective launch. Immunovia will employ a small sales team focused on the top high-risk surveillance programs for pancreatic cancer. Their goal will be to drive trial and adoption of the test at these expert centers, creating advocacy among the key opinion leaders in pancreatic cancer. We expect the broader selling effort to be executed later by a strategic partner, deploying a much larger sales team to expand reach and drive volume among pancreatologists, interventional endoscopists, gastroenterologists and genetic counselors.

We will conduct additional clinical studies required by US payers. We will conduct two additional clinical validity studies in the high-risk hereditary patient population in the first half of 2025. We will then investigate additional high-risk groups, including individuals with new-onset diabetes, chronic pancreatitis, and pancreatic cysts. Fortunately, we expect to conduct this clinical program quickly and at a reasonable cost by utilizing Immunovia biobank samples, plus samples from pancreatic cancer centers where we have strong relationships. Further, as announced in August 2024, Immunovia’s next-generation test will be studied as part of a National Institutes of Health (US) clinical program in pancreatic cyst patients.

We will pursue a strategic partner to drive commercialization of the test. Lessons from the IMMray PanCan-d launch made it clear we need a strategic partner to help commercialize our next-generation test. Partnering with a diagnostics company with a large sales force will enable us to drive more test volume, sooner and at a lower cost. Over the last 18 months, we have established relationships with more than a dozen promising prospective partners, holding regular update meetings. After successful completion of the clinical validation study we will share study results with them.

We will be intentional about the timing of any partnership. We will develop the product and clinical portfolio far enough to secure attractive terms. We will diligently pursue a strategic partner in the coming quarters and strike an agreement when timing is optimal.

We are well positioned to fund activities for the next twelve months and will strategically manage capital needs. In 2025 we will shift spending from research and product development to clinical studies and a targeted introduction of the test in the US. We will strategically evaluate the optimal timing and vehicles to fund these operating expenses beyond the next twelve months.

The Immunovia team is committed to rewarding our shareholders. I want to emphasize how committed we are as a team to seeing Immunovia succeed. This is a passionate, dedicated, resilient group of people and I’m incredibly proud to see their hard work paying off. I believe deeply in what we are doing. As evidence of my belief and engagement, I purchased 1,470,588 units in the rights issue, 140 percent of my pro rata share of the issue.

I welcome your input and feedback on how we achieve our goals and deliver value for shareholders. Contact me at info@immunovia.com with questions or suggestions. Also, please follow and connect with us on LinkedIn https://www.linkedin.com/company/immunovia-ab/. This platform provides an excellent opportunity for me to share information with you beyond our quarterly reports and press releases.

November 27, 2024
Jeff Borcherding, CEO and President
Immunovia AB

For more information, please contact:

Jeff Borcherding
CEO and President
jeff.borcherding@immunovia.com

Karin Almqvist Liwendahl
Chief Financial Officer
karin.almqvist.liwendahl@immunovia.com
+46 70 911 56 08

The information in this report is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 am CET on November 27, 2024. 

Conference call

Immunovia will hold a webcast tele conference at 15:00 pm CET on November 27 with President and CEO Jeff Borcherding and CFO Karin Almqwist Liwendahl.

To take part of the presentation, please dial one of the numbers or watch via the web link below.

Sweden: +46 8 5051 0031
United Kingdom: +44 207 107 06 13
United States: +1 631 570 56 13

Link to the webcast: https://access.creomediamanager.com/registration/0cb413c2-e586-432a-8ccd-449b18e56ee0?ref=https%3A%2F%2Fcreo-live.creomediamanager.com%2F0cb413c2-e586-432a-8ccd-449b18e56ee0

Immunovia in brief

Immunovia AB is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer.

Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer.

USA is the world’s largest market for detection of pancreatic cancer. The company estimates that in the USA, 1.8 million individuals are at high-risk for pancreatic cancer and could benefit from annual surveillance testing.

Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com

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SOURCE Immunovia AB

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FRONTLINE PLC REPORTS RESULTS FOR THE THIRD QUARTER ENDED SEPTEMBER 30, 2024

Frontline plc (the “Company”, “Frontline,” “we,” “us,” or “our”), today reported unaudited results for the three and nine months ended September 30, 2024:
  

Highlights

• Profit of $60.5 million, or $0.27 per share for the third quarter of 2024.
• Adjusted profit of $75.4 million, or $0.34 per share for the third quarter of 2024.
• Declared a cash dividend of $0.34 per share for the third quarter of 2024.
• Reported revenues of $490.3 million for the third quarter of 2024.
• Achieved average daily spot time charter equivalent earnings (“TCEs”)¹ for VLCCs, Suezmax tankers and LR2/Aframax tankers in the third quarter of $39,600, $39,900 and $36,000 per day, respectively.
• Sold its oldest Suezmax tanker, built in 2010, for a net sales price of $48.5 million and delivered the vessel to its new owner in October 2024. The transaction generated net cash proceeds of $36.5 million after repayment of existing debt.
• Fully repaid the shareholder loan with Hemen Holding Limited, the Company’s largest shareholder (“Hemen”) and the $275.0 million senior unsecured revolving credit facility with an affiliate of Hemen for an aggregate amount of $470.0 million in the second, third and fourth quarters of 2024.
• Entered into a sale-and-leaseback agreement in an amount of up to $512.1 million to refinance 10 Suezmax tankers. The refinancing is expected to generate net cash proceeds of approximately $101.0 million in the fourth quarter of 2024.

Lars H. Barstad, Chief Executive Officer of Frontline Management AS, commented:
“The third quarter of 2024 performed in line with seasonal expectations, as oil demand slowed over the summer months and domestic demand by oil exporting countries in the Middle East increased. We continue to sail in a troubled geopolitical landscape and with lower year-on-year demand in Asia, and especially China, the tanker markets have yet to experience the seasonal upswing into winter. The increase in sanctioned oil trade and movement of illicit barrels have negatively impacted our trade environment. However, global oil demand is still growing, and with limited new tanker capacity coming, Frontline continues to profit as we run our cost-efficient operation and modern fleet. It will be interesting to see how the tanker market, including the trade of oil and energy, is impacted by politics as we approach 2025.”

Inger M. Klemp, Chief Financial Officer of Frontline Management AS, added:
“In 2024 we have optimized the capital structure of the Company by refinancing debt of 36 vessels, which has extended maturities and improved margins, divesting eight older vessels and the subsequent repayment of the Hemen shareholder loan and the $275.0 million senior unsecured revolving credit facility with an affiliate of Hemen in an aggregate amount of $470.0 million. We continue to focus on maintaining our competitive cost structure, breakeven levels and solid balance sheet to ensure that we are well positioned to generate significant cash flow and create value for our shareholders.”

Average daily TCEs and estimated cash breakeven rates

We expect the spot TCEs for the full fourth quarter of 2024 to be lower than the spot TCEs currently contracted, due to the impact of ballast days during the fourth quarter of 2024. See Appendix 1 for further details.

The Board of Directors
Frontline plc
Limassol, Cyprus
November 26, 2024

Ola Lorentzon – Chairman and Director
John Fredriksen – Director
Ole B. Hjertaker – Director    
James O’Shaughnessy – Director
Steen Jakobsen – Director
Cato Stonex – Director

Questions should be directed to:

Lars H. Barstad: Chief Executive Officer, Frontline Management AS
+47 23 11 40 00

Inger M. Klemp: Chief Financial Officer, Frontline Management AS
+47 23 11 40 00
  

Forward-Looking Statements

Matters discussed in this report may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements, which include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts.

Frontline plc and its subsidiaries, or the Company, desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with this safe harbor legislation. This report and any other written or oral statements made by us or on our behalf may include forward-looking statements, which reflect our current views with respect to future events and financial performance and are not intended to give any assurance as to future results. When used in this document, the words “believe,” “anticipate,” “intend,” “estimate,” “forecast,” “project,” “plan,” “potential,” “will,” “may,” “should,” “expect” and similar expressions, terms or phrases may identify forward-looking statements.

The forward-looking statements in this report are based upon various assumptions, including without limitation, management’s examination of historical operating trends, data contained in our records and data available from third parties. Although we believe that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, we cannot assure you that we will achieve or accomplish these expectations, beliefs or projections. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

In addition to these important factors and matters discussed elsewhere herein, important factors that, in our view, could cause actual results to differ materially from those discussed in the forward-looking statements include:

• the strength of world economies;
• fluctuations in currencies and interest rates, including inflationary pressures and central bank policies intended to combat overall inflation and rising interest rates and foreign exchange rates;
• the impact that any discontinuance, modification or other reform or the establishment of alternative reference rates have on the Company’s floating interest rate debt instruments;
• general market conditions, including fluctuations in charter hire rates and vessel values;
• changes in the supply and demand for vessels comparable to ours and the number of newbuildings under construction;
• the highly cyclical nature of the industry that we operate in;
• the loss of a large customer or significant business relationship;
• changes in worldwide oil production and consumption and storage;
• changes in the Company’s operating expenses, including bunker prices, dry docking, crew costs and insurance costs;
• planned, pending or recent acquisitions, business strategy and expected capital spending or operating expenses, including dry docking, surveys and upgrades;
• risks associated with any future vessel construction;
• our expectations regarding the availability of vessel acquisitions and our ability to complete vessel acquisition transactions as planned;
• our ability to successfully compete for and enter into new time charters or other employment arrangements for our existing vessels after our current time charters expire and our ability to earn income in the spot market;
• availability of financing and refinancing, our ability to obtain financing and comply with the restrictions and other covenants in our financing arrangements;
• availability of skilled crew members and other employees and the related labor costs;
• work stoppages or other labor disruptions by our employees or the employees of other companies in related industries;
• compliance with governmental, tax, environmental and safety regulation, any non-compliance with U.S. or European Union regulations;
• the impact of increasing scrutiny and changing expectations from investors, lenders and other market participants with respect to our ESG policies;
• Foreign Corrupt Practices Act of 1977 or other applicable regulations relating to bribery;
• general economic conditions and conditions in the oil industry;
• effects of new products and new technology in our industry, including the potential for technological innovation to reduce the value of our vessels and charter income derived therefrom;
• new environmental regulations and restrictions, whether at a global level stipulated by the International Maritime Organization, and/or imposed by regional or national authorities such as the European Union or individual countries;
• vessel breakdowns and instances of off-hire;
• the impact of an interruption in or failure of our information technology and communications systems, including the impact of cyber-attacks upon our ability to operate;
• potential conflicts of interest involving members of our board of directors and senior management;
• the failure of counter parties to fully perform their contracts with us;
• changes in credit risk with respect to our counterparties on contracts;
• our dependence on key personnel and our ability to attract, retain and motivate key employees;
• adequacy of insurance coverage;
• our ability to obtain indemnities from customers;
• changes in laws, treaties or regulations;
• the volatility of the price of our ordinary shares;
• our incorporation under the laws of Cyprus and the different rights to relief that may be available compared to other countries, including the United States;
• changes in governmental rules and regulations or actions taken by regulatory authorities;
• government requisition of our vessels during a period of war or emergency;
• potential liability from pending or future litigation and potential costs due to environmental damage and vessel collisions;
• the arrest of our vessels by maritime claimants;
• general domestic and international political conditions or events, including “trade wars”;
• any further changes in U.S. trade policy that could trigger retaliatory actions by the affected countries;
• potential disruption of shipping routes due to accidents, environmental factors, political events, public health threats, international hostilities including the ongoing developments in the Ukraine region and the developments in the Middle East, including the armed conflict in Israel and the Gaza Strip, acts by terrorists or acts of piracy on ocean-going vessels;
• the length and severity of epidemics and pandemics and their impacts on the demand for seaborne transportation of crude oil and refined products;
• the impact of port or canal congestion;
• business disruptions due to adverse weather, natural disasters or other disasters outside our control; and
• other important factors described from time to time in the reports filed by the Company with the Securities and Exchange Commission.

We caution readers of this report not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are no guarantee of our future performance, and actual results and future developments may vary materially from those projected in the forward-looking statements.

This information is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act.

¹ This press release describes Time Charter Equivalent earnings and related per day amounts and spot TCE currently contracted, which are not measures prepared in accordance with IFRS (“non-GAAP”). See Appendix 1 for a full description of the measures and reconciliation to the nearest IFRS measure.