Latest news with #FALCON
Yahoo
13 hours ago
- Business
- Yahoo
Commvault Unveils New Post-Quantum Cryptography Capabilities to Help Customers Protect Data from a New Generation of Security Threats
Expanded support for new encryption standards empowers customers to proactively safeguard long-term sensitive data against 'harvest now, decrypt later' quantum threats TINTON FALLS, N.J., June 9, 2025 /PRNewswire/ -- At a time when quantum computing is rapidly emerging as an entirely new security challenge for organizations and governments around the world, Commvault, a leading provider of cyber resilience and data protection solutions for the hybrid cloud and one of the first cyber resilience vendors to support post-quantum cryptography (PQC), today announced enhancements to its PQC capabilities. These advancements are designed to help customers protect their highly sensitive, long-term data from a new generation of imminent but unknown cyber threats, creating an additional layer of support, when needed. Quantum computing uses quantum mechanics to process data and solve complex problems that could take decades with classical computers. However, these advancements bring unprecedented security challenges, along with the potential for threat actors to use quantum computing to decipher and unlock traditional encryption methods. According to the Information Systems Audit and Control Association's (ISACA) Quantum Computing Pulse Poll, 63% of technology and cybersecurity professionals say quantum will increase or shift cybersecurity risks and 50% believe it will present regulatory and compliance challenges1. Now is the time to prepare and take action. Commvault has provided support for quantum-resistant encryption standards, like CRYSTALS-Kyber, CRYSTALS-Dilithium, SPHINCS+, and FALCON, as recommended by the National Institute of Standards and Technology (NIST) since August 2024. It was then that Commvault introduced a cryptographic agility (crypto-agility) framework, enabling its customers, via the Commvault Cloud platform, to address rapidly evolving threats without overhauling their systems. With today's announcement, Commvault has built on that framework by adding support for Hamming Quasi-Cyclic (HQC), a new error correcting code-based algorithm designed to defend against threats like 'harvest now, decrypt later' where adversaries are intercepting encrypted network traffic and storing it for a later time when quantum computers are powerful enough to decrypt it. "The quantum threat isn't theoretical," said Bill O'Connell, Chief Security Officer at Commvault. "We were among the first cyber resilience vendors to address post-quantum computing, and by integrating new algorithms like HQC and advancing our crypto-agility framework, we are providing our customers with the tools to navigate this complex landscape with confidence. Our goal is simple and clear: as quantum computing threats emerge, we intend to help our customers keep their data protected." For industries where long-term data storage is required, like finance and healthcare, Commvault's expanded post-quantum cryptography capabilities provide access to a variety of safeguards that can help fortify network tunnels against quantum-based attacks. With Commvault's Risk Analysis capabilities, customers can discover and classify data to determine where these cryptographic capabilities may be helpful. In addition, Commvault's capabilities are simple to implement, often using a checkbox configuration, making it easy for customers to utilize when needed. The evolving quantum landscape – the need for speedAs investments pour into the quantum field, the time to address emerging threats is shrinking. This makes proactive adoption of post-quantum cryptography critical. "Quantum readiness has become a business imperative, particularly for industries which handle data that remains sensitive for decades. The time when currently encrypted data can be decrypted using quantum technology is closer than many people think," said Phil Goodwin, Research VP, IDC. "Commvault's early adoption of quantum-resistant cryptography and commitment to crypto-agility positions it at the forefront among data protection software vendors in proactively addressing quantum threats. Organizations with sensitive, long-term data need to prepare now for a quantum world." "Commvault has been an invaluable partner in our journey to enhance cyber resilience. Their leadership in adopting post-quantum cryptography, combined with their crypto-agility framework, is exactly what we need to meet stringent government security mandates and protect highly sensitive information from emerging quantum threats," said Jeff Day, Deputy Chief Information Security Officer, Nevada Department of Transportation. "Safeguarding sensitive data is paramount, and the long-term threat of quantum decryption is a significant concern. Commvault's rapid integration of NIST's quantum-resistant standards, particularly HQC, gives us great confidence that our critical information is protected now and well into the future," said Peter Hands, Chief Information Security Officer, British Medical Association. "Their commitment to crypto-agility is important for healthcare organizations like ours." Availability Commvault's post-quantum cryptography capabilities, including support for NIST's HQC algorithm, are immediately available to all Commvault Cloud customers running software version CPR 2024 (11.36) and later, enabling seamless adoption of quantum-resistant protection. To learn more about Commvault's quantum-resistant encryption solutions and how to future-proof your data security strategy, read today's blog, watch our executive videos here and here, and check out the executive brief. About CommvaultCommvault (NASDAQ: CVLT) is the gold standard in cyber resilience, helping more than 100,000 organizations keep data safe and businesses resilient and moving forward. Today, Commvault offers the only cyber resilience platform that combines the best data security and rapid recovery at enterprise scale across any workload, anywhere—at the lowest TCO. 1 ISAC. (2025, April 28). Despite Rising Concerns, 95% of Organizations Lack a Quantum Computing Roadmap, ISACA Finds [press release]. View original content to download multimedia: SOURCE COMMVAULT Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
08-05-2025
- Business
- Yahoo
Terns Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Corporate Updates
Initiated dose expansion in Phase 1 CARDINAL trial of TERN-701 in 2L+ CML Additional safety and efficacy data including 6-month MMR expected in 4Q25 Phase 2 FALCON trial of TERN-601 for obesity is enrolling well with top-line 12-week weight loss data expected in 4Q25 FOSTER CITY, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ('Terns' or the 'Company') (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today reported financial results for the first quarter ended March 31, 2025, and provided corporate updates. 'Terns had a strong start to 2025, marked by continued excellent execution on our two lead clinical programs. The dose escalation portion of the TERN-701 Phase 1 study for CML was completed in less than a year, and we are thrilled to report that we have initiated enrollment in the dose expansion portion of the study,' stated Amy Burroughs, chief executive officer of Terns. 'The rapid enrollment in our Phase 2 FALCON trial of TERN-601 in obesity highlights strong interest from patients and clinical investigators in the differentiated profile of this oral small molecule GLP1-RA. We remain on track to deliver meaningful data from both these studies in the second half of this year and have a cash runway that extends into 2028.' 'TERN-701 showed highly encouraging safety with no dose limiting toxicities in dose escalation up to the maximum dose of 500 mg, linear pharmacokinetics with once daily dosing, and compelling molecular responses in patients with high CML disease burden who had responded poorly to multiple prior therapies including asciminib,' said Emil Kuriakose MD, chief medical officer of Terns. 'The favorable safety profile and dose-related increase in molecular responses with TERN-701 allowed us to select doses at the top end of the dose range to take forward to dose expansion.' Recent Clinical Pipeline Developments and Anticipated Milestones TERN-701: Oral, small-molecule next-generation allosteric BCR-ABL inhibitor for chronic myeloid leukemia (CML) In April 2025, Terns enrolled the first patient in the dose expansion portion of the Phase 1 CARDINAL study of TERN-701 for CML. Patients will be randomized to one of two dose cohorts (320 mg or 500 mg QD) with up to 40 patients per arm. Doses were selected based on the totality of safety, efficacy, and PK/PD data from dose escalation Terns plans to report additional safety and efficacy data from the dose escalation and expansion portions of the study in 4Q 2025, when the study has sufficient patient enrollment and duration of follow-up to meaningfully assess 6-month major molecular response rates (regulatory approval endpoint) and inform the path to a pivotal trial In December 2024, Terns announced interim data from the TERN-701 dose escalation portion of the study, showing: Starting at the lowest dose, compelling molecular responses in heavily pre-treated CML patients with high baseline BCR-ABL transcript levels Encouraging safety profile with no dose limiting toxicities, adverse event-related treatment discontinuations or dose reductions at any dose TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity Key objectives of the FALCON Phase 2 trial are to demonstrate competitive weight loss at 12-weeks, a class-leading safety/tolerability profile, and the simplest dose titration amongst GLP1-RA therapies The FALCON Phase 2 trial is ongoing with top-line 12-week data expected in 4Q 2025 U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601 Once-daily dosing with or without food in adults with obesity or who are overweight, without diabetes (BMI ranges from ≥30 to <50 kg/m2 or ≥27 to <30 kg/m2 with at least one weight-related comorbidity) Patients randomized to one of four active cohorts (n=30 per cohort): 250 mg, 500 mg, 500 mg slow titration, 750 mg or placebo Primary endpoint is percent change from baseline in body weight compared to placebo over 12 weeks Secondary endpoints include safety, tolerability and proportion of patients achieving 5% weight loss or greater Doses and titration schema for the Phase 2 were selected based on positive results from the Phase 1 study, announced in September 2024, which demonstrated weight loss over 28-days up to 5.5% and favorable safety and tolerability despite rapid dose titration every three days Pipeline and Partnering Programs TERN-800 Series: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist Terns is prioritizing its discovery efforts on nominating a GIPR antagonist development candidate based on in-house discoveries and growing scientific rationale supporting the potential of GLP-1 agonist/GIPR antagonist combinations for obesity TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist Based on non-clinical studies, THR-β is a complementary mechanism to GLP-1, potentially providing broader metabolic and liver benefits in addition to increased weight loss Corporate Updates Members of Terns' senior leadership team will participate in the following upcoming investor conferences: Jefferies Global Healthcare Conference in New York City, New York being held June 3rd – June 5th, 2025 Goldman Sachs 46th Annual Global Healthcare Conference in Miami, Florida being held June 9th – June 11th, 2025 Webcasts of these events can be accessed at the Terns website under the 'Events & Presentations' tab on the 'Investors' section of the Company's website on the day of the event: First Quarter 2025 Financial Results Cash Position: As of March 31, 2025, cash, cash equivalents and marketable securities were $334.3 million, as compared with $358.2 million as of December 31, 2024. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2028. Research and Development (R&D) Expenses: R&D expenses were $18.7 million for the quarter ended March 31, 2025, as compared with $18.6 million for the quarter ended March 31, 2024. General and Administrative (G&A) Expenses: G&A expenses were $8.7 million for the quarter ended March 31, 2025, as compared with $6.9 million for the quarter ended March 31, 2024. Net Loss: Net loss was $23.9 million for the quarter ended March 31, 2025, as compared with $22.4 million for the quarter ended March 31, 2024. Financial Tables Terns Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (Unaudited; in thousands except share and per share amounts) Three Months Ended March 31, 2025 2024 Operating expenses: Research and development $ 18,720 $ 18,587 General and administrative 8,707 6,859 Total operating expenses 27,427 25,446 Loss from operations (27,427 ) (25,446 ) Interest income 3,643 3,182 Other expense, net (36 ) (12 ) Loss before income taxes (23,820 ) (22,276 ) Income tax expense (88 ) (97 ) Net loss $ (23,908 ) $ (22,373 ) Net loss per share, basic and diluted $ (0.26 ) $ (0.30 ) Weighted average common stock outstanding, basic and diluted 91,473,948 74,399,378 Terns Pharmaceuticals, Inc. Selected Balance Sheet Data (Unaudited; in thousands) March 31, 2025 December 31, 2024 Cash, cash equivalents and marketable securities $ 334,264 $ 358,164 Total assets 339,315 363,929 Total liabilities 13,272 18,059 Total stockholders' equity 326,043 345,870 About Terns PharmaceuticalsTerns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns' pipeline contains multiple clinical stage development programs including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1 receptor agonist, a THR-β agonist, and a preclinical GIPR modulator discovery effort, prioritizing a GIPR antagonist nomination candidate. For more information, please visit: Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements about the Company within the meaning of the federal securities laws, including those related to expectations, timing and potential results of the clinical trials and other development activities of the Company and its partners, including with respect to CARDINAL and FALCON trials, as well as enabling and human studies of the TERN –800 Series and TERN-501; the potential indications to be targeted by the Company with its small-molecule product candidates; the therapeutic potential of the Company's small-molecule product candidates; the potential for the mechanisms of action of the Company's product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company's product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company's clinical trials; the Company's clinical development plans and activities, including the results of any interactions with regulatory authorities on its programs; the Company's expectations regarding the profile of its product candidates, including efficacy, tolerability, safety, metabolic stability and pharmacokinetic profile and potential differentiation as compared to other products or product candidates; the Company's plans for and ability to continue to execute on its current development strategy, including potential combinations involving multiple product candidates; the potential commercialization of the Company's product candidates; the Company's plans and expectations around the addition of key personnel; and the Company's expectations with regard to its cash runway and sufficiency of its cash resources. All statements other than statements of historical facts contained in this press release, including statements regarding the Company's strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'design,' 'due,' 'estimate,' 'expect,' 'goal,' 'intend,' 'may,' 'objective,' 'plan,' 'positioned,' 'potential,' 'predict,' 'seek,' 'should,' 'target,' 'will,' 'would' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company's plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company's current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2024. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Contacts for Terns InvestorsKaytee Bock Zafereoinvestors@ MediaJenna UrbanCG Life media@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Upturn
08-05-2025
- Business
- Business Upturn
Pharming Group reports first quarter 2025 financial results and provides business update
First quarter 2025 total revenues increased by 42% to US$79.1 million, compared to the first quarter 2024 RUCONEST® revenue increased by 49% to US$68.6 million, compared to the first quarter 2024, reflecting continued momentum and the product's unique position in the on-demand HAE market Joenja® (leniolisib) volume increase by 18% and revenue increased by 9% to US$10.5 million, compared to the first quarter of 2024, with accelerating patient uptake compared to the prior few quarters Operating profit, adjusted to exclude the impact of non-recurring Abliva acquisition-related expenses, amounted to US$0.8 million compared to a US$16.3 million loss in the first quarter 2024 Launched Joenja® (leniolisib) in England and Wales in April and preparing to file for U.S. FDA approval for pediatrics in the third quarter 2025 Completed the acquisition of Abliva AB during the quarter and, in April, promptly started the second wave of recruitment for the pivotal FALCON clinical trial in mitochondrial DNA-driven primary mitochondrial diseases 2025 total revenue guidance raised to US$325 – US$340 million, up from prior US$315 – US$335 million Announces that Jeroen Wakkerman, Chief Financial Officer, will leave Pharming at the end of the month, to pursue other opportunities Pharming to host a conference call today at 13:30 CEST (7:30 am EDT) Leiden, the Netherlands, May 8, 2025: Pharming Group N.V. ('Pharming' or 'the Company') (Euronext Amsterdam: PHARM / Nasdaq: PHAR) presents its preliminary unaudited financial report for the three months ended March 31, 2025. Chief Executive Officer, Fabrice Chouraqui commented: 'We ended 2024 with great momentum, and 2025 has started on an even stronger note. First quarter RUCONEST® revenue increased by 49% vs. 2024 and we are seeing an acceleration in the number of Joenja® patients on commercial therapy ahead of the growth expected in the second half from VUS patients reclassified as APDS patients. Our strong performance and solid fundamentals give us the confidence to raise our full-year revenue guidance. In addition, we are optimizing capital allocation to drive sustainable growth by targeting a 15% or $10 million annual reduction in G&A expenses. Our efforts to make Joenja® available to additional APDS patients are bearing fruit. We launched Joenja® in England and Wales in late April following a positive reimbursement decision from NICE and we received our fourth country regulatory approval in Australia. We are preparing to file for U.S. FDA approval for pediatrics in the third quarter and potentially launch in the first quarter of 2026. We are making strong progress advancing high value programs in our pipeline. Patient enrollment is on track in both proof of concept trials studying leniolisib in larger PID indications. In addition, approximately a month after completing the Abliva acquisition, we successfully started the second wave of patient recruitment in the pivotal FALCON clinical trial for KL1333 in primary mitochondrial diseases, achieving a key milestone in our integration plan. I would like to thank Jeroen Wakkerman for his contributions to the growth of Pharming and the development of the Finance team over the past four years. We have initiated a search for a new CFO to lead our financial strategy going forward. Overall, this strong quarter is another illustration of our execution capabilities and future growth prospects. We look forward to providing future updates on our significant upcoming near- and long-term catalysts.' First quarter 2025 highlights Commercialized products RUCONEST® marketed for the treatment of acute HAE attacks RUCONEST® demonstrated significant strength in the first quarter of 2025, with revenues of US$68.6 million, a 49% increase compared to the first quarter of 2024. The U.S. market contributed 97% of first quarter revenues, while the EU and Rest of World contributed 3%. The strong performance was mainly driven by the continued increase in prescribers and patients on therapy in the U.S. We achieved over 90 new patient enrollments in the U.S. in the first quarter, demonstrating continued strength in underlying in-market demand for RUCONEST®. Unit sales volume in the U.S. increased by 37% due to increased demand and reduced customer inventory destocking compared to the first quarter of 2024. Joenja® (leniolisib) marketed for the treatment of APDS Joenja® revenues increased to US$10.5 million in the first quarter of 2025, a 9% increase compared to the fourth quarter of 2024. Unit sales volume increased by 18% due to the continued increase in patients on paid therapy. Quarter over quarter revenue growth was below unit sales volume growth, reflecting higher gross-to-net adjustments compared to the prior year. Gross-to-net adjustment in the current quarter were in line with expectations. The U.S. market contributed 90% of first quarter revenues, while the EU and Rest of World contributed 10%. As of March 31, 2025, we had 102 patients on paid therapy in the U.S., representing a 23% increase from the 83 patients at the end of the first quarter of 2024 and an increase of six patients during the quarter. We are making continued progress finding, enrolling and transitioning eligible patients to paid therapy and the increase in patients added during the quarter was the largest since the second quarter of 2024. The acceleration in the growth of patients on commercial therapy in the U.S. was achieved independent of the expected positive impact from Variant of Uncertain Significance, or VUS, patient reclassifications later this year. We launched Joenja® in the U.K. in April. On April 23, 2025 the National Institute for Health and Care Excellence (NICE) issued positive final guidance recommending Joenja® (leniolisib) for reimbursement and use within the National Health Service (NHS) in England and Wales for the treatment of APDS in adult and pediatric patients 12 years of age and older. Leniolisib is now available for use and funded in England through the Innovative Medicines Fund, ensuring immediate patient access. In Wales, leniolisib is expected to be funded starting in July through the NHS in specialist centers. APDS patient finding We have now identified approximately 250 APDS patients in the U.S., including over 160 patients 12 years of age or older who are eligible for treatment with Joenja®, demonstrating progress finding additional patients. As of December 31, 2024, we had identified over 880 diagnosed APDS patients worldwide. APDS patient finding – VUS reclassification There are currently over 1,300 patients in the U.S. with a Variant of Uncertain Significance, or VUS, in the PIK3CD or PIK3R1 genes. As previously communicated, an in vitro high throughput screening study was completed in the fourth quarter of 2024, identifying many novel variants leading to PI3Kδ hyperactivity. We expect the results of this study to be published shortly, and clinical genetics laboratories in the U.S. are undertaking efforts to reclassify variants they deem to be disease-causing and thus issue amended genetic testing reports with an APDS diagnosis for many of the VUS patients. We anticipate that these initiatives will lead to the identification of new patients with APDS eligible for therapy with Joenja®, adding an additional growth lever during the second half of 2025. Joenja® (leniolisib) development In total, there are currently 204 patients in a leniolisib Expanded Access Program (compassionate use), an ongoing clinical study, or a named patient program, of whom 187 are APDS patients. Leniolisib for APDS Pediatric clinical development On May 2, 2025, positive clinical results from the multinational Phase III clinical trial evaluating leniolisib tablets in children 4 to 11 years of age with APDS were presented at the 2025 Annual Meeting of the Clinical Immunology Society (CIS) in Philadelphia, PA. The data are consistent with the improvements seen in the previously reported randomized controlled trial in adolescent and adult APDS patients. Based on U.S. FDA feedback, we plan to submit a regulatory filing for pediatric label expansion in the U.S. in the third quarter of 2025. In April 2025, the Phase III pediatric clinical trial evaluating a new pediatric formulation of leniolisib in children 1 to 6 years of age completed enrollment with 16 patients. Japan We are on track to submit a regulatory filing with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in mid-2025. An approval decision would be expected nine months later based on priority review of the application due to orphan drug designation (ODD) by the Ministry of Health, Labour and Welfare of Japan (MHLW) for the treatment of APDS. European Economic Area (EEA) In regard to the ongoing review of the leniolisib Marketing Authorisation Application (MAA) for the treatment of adult and pediatric patients 12 years of age and older, we are on track to complete the manufacturing activities requested by the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) and submit a response by the January 2026 deadline. Additional markets Joenja® was approved in Israel in 2024 and in Australia in March 2025, with reimbursement discussions/negotiations ongoing with government payors in both countries. Regulatory reviews are ongoing for APDS patients 12 years of age and older in Canada and Saudi Arabia, with decisions expected in 2026, and South Korea, where we filed a regulatory submission in March 2025. Leniolisib for additional primary immunodeficiencies (PIDs) We are developing leniolisib for additional primary immunodeficiencies, or PIDs, which affect significantly more patients than APDS. These include (i) genetically identifiable PIDs with immune dysregulation linked to altered PI3Kδ signaling and (ii) common variable immunodeficiency, or CVID, with immune dysregulation identified independently of genetics. Leniolisib, by modulating PI3Kδ activity, could help in the treatment of PID patients with immune dysregulation, positively impacting their clinical manifestations of autoimmunity and end-organ lympho-infiltrative disease. We started a Phase II clinical trial evaluating leniolisib for PIDs with immune dysregulation linked to altered PI3Kẟ signaling in October 2024, and a Phase II clinical trial for CVID with immune dysregulation in February 2025. We initiated patient dosing in the CVID study in March 2025. Enrollment in both clinical trials is proceeding as planned. Acquisition of Abliva AB We completed the acquisition of Abliva AB, via a public cash offer to the shareholders to acquire all issued and outstanding shares for approximately US$66.1 million, in March 2025. Abliva's lead product KL1333 is currently in a pivotal clinical trial in primary mitochondrial diseases and has the potential to significantly enhance our future growth trajectory. The acquisition was accounted for as a business combination with substantially all of the value of the acquisition concentrated in a single asset, KL1333. The acquisition is reflected in our first quarter financial statements, with the acquisition price allocated to the fair value of the acquired identifiable assets and liabilities and the excess recorded as goodwill. KL1333 for mitochondrial DNA-driven primary mitochondrial disease We started the second wave of patient recruitment for the pivotal FALCON clinical trial in April 2025. The FALCON clinical trial is studying KL1333 in adult patients with genetically confirmed primary mitochondrial disease (PMD) with mitochondrial DNA (mtDNA) mutations who experience consistent, debilitating fatigue and muscle weakness (myopathy), and reduced life expectancy. We continue to anticipate trial read-out in 2027 with potential FDA approval by end of 2028. Organizational updates On January 21, 2025, we announced that the Board of Directors had nominated biopharmaceutical leader Mr. Fabrice Chouraqui as Pharming's new Chief Executive Officer and Executive Director, succeeding Mr. Sijmen de Vries. Mr. Chouraqui was appointed for a term of four years at the Extraordinary General Meeting of Shareholders on March 4, 2025. Upon the appointment of Mr. Chouraqui, Mr. de Vries resigned from the Board of Directors. To ensure a smooth hand-over of tasks and responsibilities, Mr. de Vries will remain a strategic advisor to the new CEO until December 31, 2025. We announce today that Mr. Jeroen Wakkerman will leave as Chief Financial Officer on May 31, 2025, to pursue other opportunities. A search for a successor is underway, and an interim head of finance and IT has been appointed to ensure a seamless transition. Financial summary Consolidated Statement of Income 1Q 2025 1Q 2024 Amounts in US$m except per share data Total Revenues 79.1 55.6 Cost of sales (8.3) (8.4) Gross profit 70.8 47.2 Other income 0.4 0.3 Research and development (21.1) (18.5) General and administrative (22.5) (15.1) Marketing and sales (34.6) (30.2) Other Operating Costs (78.2) (63.8) Operating profit (loss) (7.0) (16.3) Other finance income 0.6 1.8 Other finance expenses (5.1) (1.6) Share of net profits in associates using the equity method (0.3) (0.5) Profit (loss) before tax (11.8) (16.6) Income tax credit (expense) (3.1) 4.2 Profit (loss) for the period (14.9) (12.4) Earnings per share Basic, attributable to equity holders of the parent (US$) (0.022) (0.019) Diluted, attributable to equity holders of the parent (US$) (0.022) (0.019) Segment information – Revenues 1Q 2025 1Q 2024 Amounts in US$m Revenue – RUCONEST® (US) 66.6 44.8 Revenue – RUCONEST® (EU and RoW) 2.0 1.2 Total Revenues – RUCONEST® 68.6 46.0 Revenue – Joenja® (US) 9.5 8.5 Revenue – Joenja® (EU and RoW) 1.0 1.1 Total Revenues – Joenja® 10.5 9.6 Total Revenues – US 76.1 53.3 Total Revenues – EU and RoW 3.0 2.3 Total Revenues 79.1 55.6 Consolidated Balance Sheet March 31, 2025 December 31, 2024 Amounts in US$m Cash and cash equivalents, restricted cash and marketable securities 108.9 169.4 Current assets 214.1 278.4 Total assets 403.2 400.0 Current liabilities 77.5 73.8 Shareholders' equity 214.0 221.1 Financial highlights On February 14, 2025, the company gained control of Abliva AB by acquiring 88.9% of the issued shares for the amount of US$60.1 million. As of the end of the first quarter of 2025, the company owns 97.5% of the issued shares following additional purchases totaling US$6.0 million. Abliva's financial position and expenses have been fully consolidated into Pharming's financial statements as of February 14, and are included in all figures and discussions that follow below. Upon consolidation, provisional amounts were recognized for the intangible asset related to KL1333 (US$63.1 million), goodwill (US$13.4 million) and deferred tax liabilities (US$12.8 million), based on the closing exchange rate at the end of the quarter. The other net identifiable assets were not significant and were recognized at fair value as of the acquisition date. Total revenues for the first quarter of 2025 increased by 42% to US$79.1 million compared to US$55.6 million in the first quarter of 2024. RUCONEST® revenues amounted to US$68.6 million, a 49% increase compared to the first quarter of 2024. The volume increase in the U.S. was the primary factor behind this increase in RUCONEST® revenues. Joenja® revenues amounted to US$10.5 million in the first quarter of 2025, a 9% increase compared to the first quarter of 2024. This increase in Joenja® revenues was mostly driven by an increase in volume, offset by gross-to-net adjustments that were higher than the prior year but in line with current year expectations. Gross profit increased by 50% to US$70.8 million (1Q 2024: US$47.2 million), mainly due to the increase in revenues. Cost of sales decreased by US$0.1 million due to lower inventory impairments, partially offset by an increase in expensed inventories due to higher revenues. The operating loss amounted to US$7.0 million, compared to an operating loss of US$16.3 million in the first quarter of 2024. Adjusted to exclude US$7.8 million of non-recurring Abliva acquisition-related expenses, of which US$5.7 million is included in General and administrative expenses and US$2.1 million in employee bonuses is included in Research and development expenses, the operating profit amounted to US$0.8 million. The improved operating result was primarily driven by an increase in revenues, partially offset by higher operating expenses. The Company had a net loss of US$14.9 million, compared to a net loss of US$12.4 million in the first quarter of 2024. The increased loss was primarily due to US$7.8 million in non-recurring Abliva acquisition-related expenses, most of which were not tax-deductible. This was partially offset by a higher gross profit. Cash generated from operations amounted to US$0.2 million, compared to US$7.6 million used in operations in the first quarter of 2024. Cash and cash equivalents, including restricted cash and marketable securities, decreased by US$60.5 million to US$108.9 million from US$169.4 million at the end of the fourth quarter of 2024, primarily driven by purchases of Abliva shares totaling US$66.1 million and non-recurring Abliva acquisition-related expenses totaling US$7.8 million. Outlook/Summary For 2025, the Company anticipates: Total revenues between US$325 million and US$340 million (9% to 14% growth), with quarterly fluctuations expected. Total operating expenses not to exceed the prior year pre-Abliva impact and we expect US$30 million in Abliva-related operating expenses, including research and development and non-recurring transaction and integration expenses. Significant progress finding additional APDS patients in the U.S., supported by VUS validation efforts and subsequently converting patients to paid Joenja® (leniolisib) therapy. Increasing ex-U.S. revenues for leniolisib – driven by funded access programs and commercial availability in the U.K. Progress towards additional regulatory approvals for leniolisib for APDS patients 12 years of age or older, and submitting regulatory filings in Japan and for pediatric label expansion in key global markets. Advancing the two ongoing Phase II clinical trials in PIDs with immune dysregulation to significantly expand the long-term commercial potential of leniolisib. Advancing the ongoing pivotal FALCON clinical study for KL1333 in mitochondrial DNA-driven primary mitochondrial diseases. Continued focus on potential acquisitions and in-licensing of clinical stage opportunities in rare diseases. No further specific financial guidance for 2025 is provided. Additional information Presentation The conference call presentation is available on the website from 07:30 CEST today. Conference Call The conference call will begin at 13:30 CEST / 07:30 EDT on Thursday, May 8. A transcript will be made available on the website in the days following the call. Please note, the Company will only take questions from dial-in attendees. Webcast Link: Conference call dial-in details: Additional information on how to register for the conference call/webcast can be found on the website. Financial Calendar 2025 Annual General Meeting of Shareholders June 112Q/1H 2025 financial results July 31 3Q 2025 financial results November 6
Yahoo
26-03-2025
- Business
- Yahoo
Mastery Made Easy: HIKMICRO's New FALCON 2.0 and CONDOR LRF 2.0 Introduced at the JAGD & HUND 2025
DORTMUND, GERMANY, March 25, 2025 (GLOBE NEWSWIRE) -- HIKMICRO, a leading optics manufacturer, will unveil its latest thermal hunting innovations, the FALCON 2.0 and CONDOR LRF 2.0 thermal monoculars, at JAGD & HUND Dortmund 2025. The event, taking place from January 28 to February 2 at Messe Dortmund, will showcase these groundbreaking devices that embody the company's "Mastery Made Easy" FALCON 2.0 and CONDOR LRF 2.0 represent significant advancements in thermal imaging technology, focusing on one-handed operation and superior image quality. These devices feature a highly sensitive 15mK thermal detector, capturing minute temperature differences and providing rich image details on a 0.49" display. The CONDOR LRF 2.0 series features an integral laser rangefinder and has an ergonomic design that cradles the hand. Meanwhile, the FALCON 2.0 maintains a traditional cylindrical shape. Mr. Wang, HIKMICRO's R&D expert, stated, "We have made comprehensive improvements to the FALCON and CONDOR models with 'Mastery Performance' and 'One-handed, easy operation' functions. We have made these advancements while maintaining high image quality to provide the most comfortable observation. The enhanced usability will deliver a simplified and intuitive operating experience." Both models incorporate HIKMICRO's Shutterless Image System (HSIS), eliminating image freeze and guaranteeing continuous, smooth viewing. The devices boast an optimized 21700 battery, offering over six hours of operation time, and are compatible with external power banks for extended use. The laser rangefinder function can precisely determine ranges up to 1000m (±1m), enhancing shot placement accuracy for safe and humane hunting. The new models feature a rear focus wheel and inline button arrangement, certifying intuitive operation for hunters of all ages. The devices offer multiple carrying options, including a neck strap, wrist lanyard, and monocular carrying bag, catering to various hunting styles and preferences. Stefan Li, HIKMICRO's overseas director, emphasized the company's commitment to innovation, stating, "HIKMICRO's vision is to keep blazing the trail by creating more precise, faster and easier ways to help hunters master the mystery of the night. These new devices reflect our dedication to user-centered innovation and understanding hunters' needs in the field." About HIKMICRO HIKMICRO is a world-leading optics brand dedicated to "Continually Make Crafted Confidence" for hunters. The company focuses on user-centered innovation, combining technological breakthroughs with traditional hunting values and expert craftsmanship to deliver superior hunting experiences. Contact Information Brand: HIKMICRO Contact: Lina Wang Email: wanglina21@ Website:
Yahoo
17-02-2025
- Politics
- Yahoo
Hackers Impersonate Saudi Crown Prince to Promote Fake ‘Official' Memecoins
Hackers took control of the Saudi Law Conference's social-media account on X, using it to impersonate Crown Prince Mohammed bin Salman and promote fraudulent cryptocurrencies. In a series of now-deleted posts, the scammers used the name and image of the crown prince, who serves as Saudi Arabia's prime minister, to promote an 'Official Saudi Arabia Memecoin' as well as a 'FALCON Memecoin.' The posts were accompanied by contract addresses to identify the tokens. The conference, a major legal event in the country, confirmed on LinkedIn that the official X account was compromised and advised users that any 'content published through the account does not represent our views or official positions in any way.' 'We confirm that we are urgently working to regain control of the account and disclaim all responsibility for any unauthorized posts made during this period. We also apologize to our followers for any inconvenience this may cause and urge everyone to exercise caution and refrain from engaging with any suspicious content posted through the account until further notice,' the Saudi Law Conference wrote. The incident comes amid controversy surrounding Argentine President Javier Milei over a post promoting a memecoin called Libra and its subsequent removal. Disclaimer: Statements from the Saudi Law Conference for this article were translated with the use of artificial intelligence.
