Latest news with #HELIOS
Yahoo
3 days ago
- Business
- Yahoo
Disc Medicine Reports Second Quarter 2025 Financial Results and Provides Business Update
Company on track to submit NDA for bitopertin in erythropoietic protoporphyria (EPP) under accelerated approval pathway in October 2025, supported by successful pre-NDA meeting Expect initial data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) and multiple dose data from Phase 1b study of DISC-0974 in patients with anemia of non-dialysis-dependent chronic kidney disease (NDD-CKD) in Q4 2025 Initiated Phase 2 study of DISC-3405 in polycythemia vera (PV) with initial data expected in 2026 Presented positive clinical data updates across the portfolio at the European Hematology Association (EHA) Annual Congress, including longer term efficacy and safety data from the HELIOS trial of bitopertin in EPP, durability data from Phase 1b study of DISC-0974 in MF anemia, and healthy volunteer data from DISC-3405 studies Strong financial position ending Q2 with $650.0 million in cash, cash equivalents, and marketable securities; expected to fund operations into 2028 WATERTOWN, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today reported financial results for the second quarter ended June 30, 2025, and provided a recap of recent program and corporate developments. 'We are pleased with the continued momentum this past quarter, highlighted by clinical data presentations that support further advancement across our programs and continued progress toward our first NDA submission. Following positive feedback from our pre-NDA meeting, we are on track to submit an NDA for bitopertin in EPP under the accelerated approval pathway in October,' said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. 'We have also made great progress across the rest of our pipeline, initiating a Phase 2 study of DISC-3405 in polycythemia vera, and looking ahead to data from the Phase 2 trial of DISC-0974 in MF anemia and Phase 1b trial in NDD-CKD anemia in the second half of the year. Our team's commitment to execution, supported by a strong balance sheet that provides cash runway into 2028, has positioned Disc to prepare for the potential commercialization of bitopertin and advance pipeline development as we enter the next phase of growth.' Recent Highlights and Anticipated Milestones:Presented data from HELIOS, an ongoing open-label extension study of bitopertin in EPP, which showed favorable long-term efficacy and safety with sustained protoporphyrin IX (PPIX) reductions, improvement in quality of life, and improved liver biomarkers Progressing confirmatory Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP Completed positive pre-NDA meeting with FDA, confirming alignment with the agency on the expected timing, format, and content of planned NDA submission for bitopertin in EPP Expect to submit an NDA in October 2025 under the FDA's accelerated approval pathway based on Disc's existing data package Publication of the results from a preclinical study conducted in collaboration with Boston Children's Hospital showing that, in mice, bitopertin may help prevent liver disease in EPP, in addition to ameliorating blood PPIX levels. The paper, 'The GLYT1 inhibitor bitopertin mitigates erythroid PPIX production and liver disease in erythroid protoporphyria,' was published in the Journal of Clinical Investigation (corresponding authors Sarah Ducamp and Paul Schmidt)Hosted a virtual MF Anemia KOL event on May 9, 2025, discussing DISC-0974 and its potential to play a significant role in the treatment of anemia in patients with MF A replay of the webcast is available on the Events & Presentations page on the investor relations portion of the Company website Presented clinical data from the continuation phase of the Phase 1b trial of DISC-0974 in MF anemia demonstrating durable hematologic response at EHA 2025 Progressing RALLY-MF Phase 2 study of DISC-0974 in patients with anemia of MF with initial data expected in Q4 2025 Exploratory cohort for patients on concomitant momelotinib or pacritinib fully enrolled, and trial protocol updated to allow patients on these therapies into the main study cohorts Progressing Phase 1b study of DISC-0974 in patients with anemia of NDD-CKD with multiple-dose data expected in Q4 2025Presented updated SAD/MAD data from the Phase 1 trial of DISC-3405 in healthy volunteers providing proof of mechanism to support advancement of the program at EHA 2025 Initiated a Phase 2 study of DISC-3405 in patients with PV with initial data expected in 2026 Corporate: Appointed Nadim Ahmed, President and CEO of Cullinan Therapeutics, to the Company's Board of Directors in July, bringing to the Company over 25 years of development and commercial leadership experience including multiple product launches in the hematology space Second Quarter 2025 Financial Results: Cash Position: Cash, cash equivalents, and marketable securities were $650.0 million as of June 30, 2025, which are expected to fund operational plans into 2028. Research and Development Expenses: R&D expenses were $46.3 million for the three months ended June 30, 2025, as compared to $23.5 million for the three months ended June 30, 2024. The increase in R&D expenses was primarily driven by the progression of Disc's portfolio, including bitopertin's clinical studies and drug manufacturing, the advancement of the DISC-0974 program, and increased headcount, as well as a payment of a $10 million milestone upon initiation of the APOLLO study. Selling, General and Administrative Expenses: SG&A expenses were $15.1 million for the three months ended June 30, 2025, as compared to $7.4 million for the three months ended June 30, 2024. The increase in SG&A expenses was primarily due to increased headcount including establishing infrastructure to support potential commercialization. Net Loss: Net loss was $55.2 million for the three months ended June 30, 2025, as compared to $26.4 million for the three months ended June 30, 2024. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline. About Disc Medicine Disc Medicine (NASDAQ:IRON) is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, potentially first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. For more information, please visit Available Information Disc announces material information to the public about the Company, its products and services, and other matters through a variety of means, including filings with the U.S. Securities and Exchange Commission (SEC), press releases, public conference calls, webcasts and the investor relations section of the Company website at in order to achieve broad, non-exclusionary distribution of information to the public and for complying with its disclosure obligations under Regulation FD. Disc Cautionary Statement Regarding Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding: Disc's expectations with respect to the next stages of its development programs for bitopertin, DISC-0974 and DISC-3405, including projected timelines for the initiation and completion of its clinical trials, anticipated timing of release of data, and other clinical activities; the registrational pathway for bitopertin, including the potential for accelerated approval and the projected timeline for an NDA submission; and the strength of its financial position and its anticipated cash runway. The use of words such as, but not limited to, 'believe,' 'expect,' 'estimate,' 'project,' 'intend,' 'future,' 'potential,' 'continue,' 'may,' 'might,' 'plan,' 'will,' 'should,' 'seek,' 'anticipate,' or 'could' or the negative of these terms and other similar words or expressions that are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Disc's current beliefs, expectations and assumptions regarding the future of Disc's business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Disc may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and investors should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of a number of material risks and uncertainties including but not limited to: the adequacy of Disc's capital to support its future operations and its ability to successfully initiate and complete clinical trials; the nature, strategy and focus of Disc; the difficulty in predicting the time and cost of development of Disc's product candidates; Disc's plans to research, develop and commercialize its current and future product candidates; the timing of initiation of Disc's planned preclinical studies and clinical trials; the timing of the availability of data from Disc's clinical trials; Disc's ability to identify additional product candidates with significant commercial potential and to expand its pipeline in hematological diseases; the timing and anticipated results of Disc's preclinical studies and clinical trials and the risk that the results of Disc's preclinical studies and clinical trials may not be predictive of future results in connection with future studies or clinical trials and may not support further development and marketing approval; and the other risks and uncertainties described in Disc's filings with the SEC, including in the 'Risk Factors' section of Disc's Annual Report on Form 10-K for the year ended December 31, 2024, and in subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement speaks only as of the date on which it was made. None of Disc, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. DISC MEDICINE, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except share and per share amounts) (Unaudited) Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Operating expenses: Research and development $ 46,319 $ 23,485 $ 74,082 $ 47,189 Selling, general and administrative 15,091 7,367 27,274 15,125 Total operating expenses 61,410 30,852 101,356 62,314 Loss from operations (61,410 ) (30,852 ) (101,356 ) (62,314 ) Other income (expense), net 6,215 4,560 12,195 9,078 Income tax expense (52 ) (60 ) (171 ) (65 ) Net loss $ (55,247 ) $ (26,352 ) $ (89,332 ) $ (53,301 ) Net loss per share, basic and diluted $ (1.58 ) $ (1.03 ) $ (2.61 ) $ (2.11 ) Weighted-average common shares outstanding, basic and diluted 35,024,592 25,649,043 34,179,364 25,229,456 DISC MEDICINE, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) June 30, December 31, 2025 2024 (Unaudited) Assets Cash, cash equivalents, and marketable securities $ 649,973 $ 489,881 Other current assets 11,619 3,734 Total current assets 661,592 493,615 Non-current assets 3,469 3,158 Total assets $ 665,061 $ 496,773 Liabilities and Stockholders' Equity Current liabilities $ 20,606 $ 23,316 Non-current liabilities 30,290 29,870 Total liabilities 50,896 53,186 Total stockholders' equity 614,165 443,587 Total liabilities and stockholders' equity $ 665,061 $ 496,773 Media Contact Peg RusconiDeerfield Investor Relations Contact Christina TartagliaPrecision AQ
Business Wire
3 days ago
- Business
- Business Wire
Amylyx Pharmaceuticals Reports Second Quarter 2025 Financial Results
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) ('Amylyx' or the 'Company') today reported financial and business results for the second quarter ended June 30, 2025. 'As we look ahead to the second half of the year and into 2026, we remain encouraged by the strength of our pipeline and the continued momentum towards our clinical milestones,' said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx. 'We expect to complete recruitment in the pivotal Phase 3 LUCIDITY trial of avexitide in 2025, with topline data anticipated in the first half of 2026. In the third quarter, we expect to share an unblinded analysis from the Phase 2b portion of our ORION trial of AMX0035 in progressive supranuclear palsy, for which we have set a high bar and will inform our decision regarding advancing to the Phase 3 portion of the trial. We also look forward to providing an update on our Wolfram syndrome program later this year, building on previous long-term Week 48 data from our Phase 2 HELIOS trial. In ALS, we were pleased to receive FDA Fast Track designation for AMX0114, and we anticipate early cohort data from the ongoing Phase 1 LUMINA trial later this year. We remain focused on disciplined execution across our programs.' Second Quarter and Recent Updates: Amylyx presented new exploratory analyses from the Phase 2 PREVENT and Phase 2b clinical trials of avexitide, a glucagon-like peptide-1 (GLP-1) receptor antagonist with U.S. Food and Drug Administration (FDA) Breakthrough Designation, for the treatment of post-bariatric hypoglycemia (PBH) at the Endocrine Society's annual meeting (ENDO 2025) in July 2025. The Phase 2 PREVENT trial evaluated avexitide in PBH following Roux-en-Y gastric bypass (RYGB) surgery, and the Phase 2b trial evaluated avexitide in PBH following a variety of upper GI surgeries, including RYGB, sleeve gastrectomy, esophagectomy, Nissen fundoplication, and gastrectomy. In the Phase 2b trial, avexitide 90 mg once daily, the dose being evaluated in the pivotal Phase 3 LUCIDITY trial, led to a 64% least-squares mean reduction (p=0.0031) vs. baseline in the composite rate of Level 2 and Level 3 hypoglycemic events in PBH, with more than half of the participants experiencing no events during the treatment period. The 45 mg twice daily, 30 mg twice daily, and 60 mg once daily dose regimens all likewise demonstrated consistent reductions in composite rate of Level 2 and Level 3 hypoglycemic events. New pharmacokinetic and pharmacodynamic data were also presented, demonstrating continuous pharmacologic activity of the 90 mg once daily dose regimen for a 24-hour period. Avexitide was generally well tolerated, with a favorable safety profile replicated across clinical trials. Amylyx presented new long-term Week 48 data from the Phase 2 open-label HELIOS clinical trial of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) in adults living with Wolfram syndrome at the Joint Congress of the European Society for Pediatric Endocrinology and the European Society of Endocrinology in May 2025. Consistent with previously presented data on the primary efficacy outcome of improvement in pancreatic beta cell function, as measured by C-peptide response to a mixed-meal tolerance test at Week 24, treatment with AMX0035 through Week 48 of the HELIOS trial demonstrated continued and sustained improvement in pancreatic beta cell function. Long-term Week 48 results also showed sustained improvements or stabilization in multiple outcomes related to disease progression, including in glycemic control, as measured by hemoglobin A1c and time in target glucose range assessed by continuous glucose monitoring, as well as visual acuity. All participants with available measurements met the responder criteria, defined as either improvement or no change, on both the Patient Global Impression of Change and Clinician Global Impression of Change at Weeks 24 and 48, indicating stability or improvement in their Wolfram syndrome-related symptoms. Results from qualitative on-study interviews further supported the potential positive impact of AMX0035 on symptom burden. Safety data were consistent with prior studies of AMX0035. Amylyx received FDA Fast Track designation for AMX0114, an investigational antisense oligonucleotide targeting knockdown of calpain-2, for people living with amyotrophic lateral sclerosis (ALS) in June 2025. Under the FDA's Fast Track Designation, AMX0114 is eligible for more frequent meetings and communications with the FDA, as well as Priority Review if relevant criteria continue to be met. Upcoming Expected Milestones: Completion of recruitment for the pivotal Phase 3 LUCIDITY clinical trial of avexitide in PBH following RYGB surgery expected in 2025, with a data readout anticipated in the first half of 2026 and, if approved, commercial launch anticipated in 2027. LUCIDITY is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in approximately 75 participants at approximately 20 sites in the U.S. LUCIDITY is evaluating the FDA-agreed-upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Unblinded analysis of the Phase 2b portion of the Phase 2b/3 ORION trial evaluating AMX0035 for progressive supranuclear palsy (PSP) expected in the third quarter of 2025. ORION is an operationally seamless Phase 2b/3 clinical trial in people living with PSP. The Phase 2b portion was fully enrolled in January 2025 with a total of 139 participants randomized. Phase 2b efficacy and safety data from an unblinded analysis with Week 24 data from all participants will be used to inform a go/no-go decision on the Phase 3 portion of the trial. Update on the AMX0035 Wolfram syndrome program expected in 2025. In 2024, Amylyx reported positive topline results from the Company's Phase 2 HELIOS trial, an open-label study of 12 adult participants. At Week 24, stabilization or improvement was demonstrated across all key clinical measures, including pancreatic function, glycemic control, and vision, including the trial's primary efficacy outcome of improvement in pancreatic function, as measured by C-peptide response to a mixed-meal tolerance test at Week 24. In May, long-term Week 48 data from HELIOS were presented at the Joint Congress of the European Society for Pediatric Endocrinology and the European Society of Endocrinology. These data demonstrated that treatment with AMX0035 led to continued sustained stabilization or improvement. These results and discussions with FDA are informing the design of a Phase 3 trial of AMX0035 in Wolfram syndrome. Early cohort data from the Phase 1 LUMINA clinical trial of AMX0114 in ALS expected in 2025. LUMINA is a multinational, randomized, double-blind, placebo-controlled, multiple ascending dose clinical trial designed to evaluate the safety and biological activity of AMX0114. The trial will also assess ALS biomarkers, including changes from baseline in neurofilament light (NfL) levels. Approximately 48 participants will be randomized 3:1 to receive AMX0114 or placebo by intrathecal administration once every four weeks, for up to four doses. Financial Results for the Second Quarter Ended June 30, 2025 R&D Expenses: Research and development expenses for the second quarter of 2025 were $27.2 million, compared to $23.3 million for the same period in 2024. The increase was primarily due to the clinical development of avexitide in PBH and AMX0035 in PSP, offset by a decrease in spending on AMX0035 in ALS. Research and development expenses include $2.0 million of stock-based compensation expense for the quarter, compared to $2.4 million of stock-based compensation expense for the same period in 2024. SG&A Expenses: Selling, general, and administrative expenses for the second quarter of 2025 were $15.6 million, compared to $21.6 million for the same period in 2024. The decrease was primarily due to a decrease in payroll and personnel-related costs and a decrease in consulting, professional services, and other expenses. Selling, general, and administrative expenses include $5.4 million of stock-based compensation expense for the quarter, compared to $7.1 million for the same period in 2024. Net Loss: Net loss for the three months ended June 30, 2025 was $41.4 million, or $0.46 per share, compared to net loss of $72.7 million, or $1.07 per share for the same period in 2024. Cash Position: Cash, cash equivalents, and marketable securities were $180.8 million at June 30, 2025, compared to $204.1 million at March 31, 2025. Based on its current operating plans, Amylyx expects its cash runway to be through the end of 2026. Investor Conference Call Information Amylyx' management team will host a conference call today, August 7, 2025, at 8:00 a.m. ET to discuss financial results and provide an update on the business. To access the conference call, please dial +1 (800)-836-8184 (U.S. & Canada) or +1 (646)-357-8785 (international) at least 10 minutes prior to the start time and ask to be joined into the Amylyx Pharmaceuticals call. A live audio webcast of the call will be available under 'Events and Presentations' in the Investor section of the Company's website, The webcast will be archived and available for replay for 90 days following the event. Available Information We periodically provide other information for investors on our corporate website, and our investor relations website, This includes press releases and other information about financial performance, information on corporate governance, and details related to our annual meeting of stockholders. We intend to use our website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor our website, in addition to following the Company's press releases, SEC filings, and public conference calls and webcasts. About Avexitide Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in five Phase 1 and Phase 2 clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism (HI). The U.S. Food and Drug Administration (FDA) has granted avexitide Breakthrough Therapy Designation for both indications, Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for the treatment of hyperinsulinemic hypoglycemia (which includes PBH and congenital HI). Avexitide is designed to bind to the GLP-1 receptor on pancreatic islet beta cells and inhibit the effect of GLP-1 to mitigate hypoglycemia by decreasing insulin secretion and stabilizing blood glucose levels. In PBH, excessive GLP-1 can lead to the hypersecretion of insulin and subsequent debilitating hypoglycemic events. In two Phase 2 PBH clinical trials, avexitide demonstrated highly statistically significant reductions in hypoglycemic events. These events can lead to autonomic and neuroglycopenic symptoms that can have a devastating impact on daily living. About Post-Bariatric Hypoglycemia (PBH) Post-bariatric hypoglycemia (PBH) is a condition that is estimated to affect approximately 8% of people in the U.S. who have undergone the two most common types of bariatric surgery, sleeve gastrectomy and Roux-en-Y gastric bypass (approximately 160,000 people in the U.S.). PBH is thought to be caused by an excessive glucagon-like peptide-1 (GLP-1) response leading to hypoglycemia and impaired quality of life. PBH can cause debilitating hypoglycemic events associated with inadequate supply of glucose to the brain, known as neuroglycopenia. Clinical manifestations can include impaired cognition, loss of consciousness, and seizures. PBH is also associated with a high degree of disability that can result in major disruptions to independent living. There are no approved therapies for PBH. About the LUCIDITY Trial LUCIDITY (NCT06747468) is an approximately 75-participant, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in participants with PBH following Roux-en-Y gastric bypass (RYGB) surgery. The Phase 3 trial is being conducted at approximately 20 sites in the U.S. Participants will be randomized 3:2 to receive either 90 mg of avexitide subcutaneously once daily or placebo. The trial includes an up to six-week screening period, including a three-week run-in period, and a 16-week double-blind treatment period. Participants who complete the double-blind period will be eligible to enter an open-label extension (OLE) period with a duration of 32 weeks. The primary efficacy objective of LUCIDITY will evaluate the FDA-agreed upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Safety and tolerability will also be evaluated. About Amylyx Pharmaceuticals At Amylyx, our mission is to usher in a new era of treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are currently focused on three investigational therapies across several neurodegenerative and endocrine diseases in which we believe they can make the greatest impact. For more information, visit and follow us on LinkedIn and X. For investors, please visit Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Amylyx' expectations regarding: the potential of avexitide as a treatment for PBH; expectations regarding the timing for recruitment completion and topline data readout of the Phase 3 LUCIDITY trial of avexitide; expectations regarding timing for potential commercialization of avexitide; expectations regarding the potential of AMX0035 (sodium phenylbutyrate and taurursodiol) as a treatment for Wolfram syndrome and PSP or other neurodegenerative diseases and planned updates to those programs; planned discussions with the FDA related to AMX0035 for the treatment of Wolfram syndrome; expectations regarding the timing of the announcement of interim results from the Company's Phase 2b/3 ORION trial of AMX0035 for the treatment of PSP; the potential for AMX0114 as a treatment for ALS, the expected timeline for data readout of the Phase 1 LUMINA clinical trial, and expectation for regulatory action; and Amylyx' expectations regarding its financial performance, cash runway and longer-term strategy. Any forward-looking statements in this press release and related comments in the Company's earnings conference call are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx' program development activities; Amylyx' ability to execute on its regulatory development plans and expectations regarding the timing of results from its planned data announcements and initiation of clinical studies; Amylyx' ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx' operations, as well as the risks and uncertainties set forth in Amylyx' United States Securities and Exchange Commission (SEC) filings, including Amylyx' Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings with the SEC. All forward-looking statements contained in this press release and related comments in our earnings conference call speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. AMYLYX PHARMACEUTICALS, INC. UNAUDITED (in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Product revenue, net $ — $ (1,023 ) $ — $ 87,620 Operating expenses: Cost of sales — 8 — 5,953 Cost of sales - inventory impairment and loss on firm purchase commitments — 7,410 — 117,871 Research and development 27,217 23,347 49,336 59,955 Selling, general and administrative 15,640 21,647 31,324 79,406 Restructuring expenses — 22,851 — 22,851 Total operating expenses 42,857 75,263 80,660 286,036 Loss from operations (42,857 ) (76,286 ) (80,660 ) (198,416 ) Other income, net 1,414 3,586 3,310 7,165 Loss before income taxes (41,443 ) (72,700 ) (77,350 ) (191,251 ) Provision for income taxes — — — 242 Net loss $ (41,443 ) $ (72,700 ) $ (77,350 ) $ (191,493 ) Net loss per share — basic and diluted $ (0.46 ) $ (1.07 ) $ (0.88 ) $ (2.82 ) Weighted-average shares used in computing net loss per share — basic and diluted 89,138,568 68,024,929 87,427,345 67,939,642 Expand
Malay Mail
5 days ago
- Business
- Malay Mail
Flux introduces new TÜV-certified smart light for vision protection
This HELIOS Pendant Light is engineered with low blue-light emission and zero flicker technology to protect screen-heavy workers from silent vision burnout. It is developed in collaboration with Malaysia's No.1 lighting expert, Richard's Prestige Lighting & Design, as a solution to address rising levels of myopia and digital eye strain globally. KUALA LUMPUR, Aug 5 — Flux, a future-focused local lighting brand, announced the launch of its HELIOS Pendant Light, a TÜV-certified smart light that aims to support long-term vision wellness for office professionals and remote creatives who spend long hours on screens under artificial lighting. The latest launch is a partnership with Malaysia's trusted lighting provider and one of the largest custom decorative lighting manufacturers in Asia Pacific, Richard's Prestige Lighting & Design, to reach out to more underserved masses in the market. Engineered with RG0 TÜV certification – an eye-safe certification that meets the highest global eye safety standard called the IEC R60 - the HELIOS features 1.2-meter-wide coverage, 1600 lux brightness, and RA>95 colour rendering, which provides soft, vibrant illumination without the typical risks of modern lighting. As a science-backed technology, it mimics natural light cycles and minimizes glare to reduce visual fatigue caused by micro-flickering LEDs and prolonged exposure to blue light. Conceptualised and birthed by a working-class professional who had experienced eye strains working late nights under the harsh white light, this HELIOS solution is also designed in response to an increasing global epidemic of digital eye strain and early-onset myopia among this current generation of workers. The precision optics system behind FLUX Helios' balanced illumination. Each layer is meticulously designed to reduce glare and enhance visual comfort. 'Our eyes are the most overworked yet overlooked productivity organ,' said Tan Ming Howe, CEO of Richard's Prestige Lighting & Design. 'HELIOS is thus built for the screen-heavy generation, including designers, remote workers, and gamers who unknowingly suffer from invisible lighting issues. We designed it not just to look great, but to protect our all-important vision in today's digital age.' Recent studies have reported that up to 68 per cent of screen users experienced digital eye strain, while 43 per cent of remote workers were quoted as saying that their sight has taken a turn for the worse since shifting to online work. Further compounding such concerns is a worsening myopia condition among the global population, where the severity is projected to hit a rate of 50 per cent by 2050. Now, thanks to the advanced features of PWM flicker-free drivers that eliminate invisible light fluctuations, RG0 photobiological safety certification, and low-blue-light diffusion embedded in HELIOS, a solution is in sight - no pun intended - where users will be able to mitigate progressive eye fatigue and prioritise their eye health. With a lifespan of 50,000 hours and backed by a 1-year warranty, customers also get to select from the light's four preset ambient modes, which are Polynesia Sky, Hungary Blue Hour, Vanuatu Beach, and Sabah Sunset, each tailored to help regulate circadian rhythm and support focused work. HELIOS is compatible with standard wall switches, enabled with intelligent motion sensing that allows for light control at a gesture of a hand wave, and convenient remote operation. FLUX Helios in 'Sabah Sunset' mode — delivering rich amber illumination designed for focus, ambiance, and eye comfort. The light has since received some glowing testimonies by different users, such as a streamer, Kelvin W., who says 'I used to get eye fatigue after 2 hours of gaming. Now I can go for hours without strain.', while remote professional & mother Aina M., calls it the 'Best home upgrade I've made. My kids can study longer, and my eyes finally feel normal.' To learn more on how you can upgrade your workspace and protect your vision with HELIOS, visit or contact the Flux team at: [email protected]. Pre-orders end on 31 August, 2025. As with its tagline, it's time to 'fix the light to save your sight'.
Business Wire
09-07-2025
- Business
- Business Wire
HELIOS and Caroline Harvey Partner to Advance Equity and Innovation in Women's Hockey
PORTSMOUTH, N.H.--(BUSINESS WIRE)--HELIOS, the leading wearable performance platform in ice hockey, proudly announces a new partnership with Caroline Harvey—Olympic medalist, World Champion, and two-time NCAA National Champion—to help close the long-standing gap in sport science and technology for female athletes. "it's about making sure the next generation has the tools, the data, and the support they need" - Caroline Harvey Share As women's sports experience unprecedented growth in participation, viewership, and investment, performance tools and research have yet to catch up. Most data standards and development models are still based on men. For female athletes, especially in hockey, that means training without a complete picture—and often without the tools to reach their full potential. Caroline Harvey is helping to change that. A generational talent with a relentless work ethic, Harvey is redefining what excellence looks like in women's hockey. From breaking records at Wisconsin to leading Team USA to multiple gold medals on the world stage, she represents not just dominance, but progress. Now, by teaming up with HELIOS, she's taking that progress off the ice—and into the broader future of the sport. 'I've always strived to play at the highest level and be at my best,' said Harvey. 'But it's not just about my journey—it's about making sure the next generation has the tools, the data, and the support they need to pursue theirs.' This partnership signals a bold commitment from HELIOS to accelerate that change. In an industry where women's sports have historically been underfunded and underserved by research, Harvey and HELIOS are working to flip the script—bringing visibility, innovation, and investment to where it's long been overdue. 'Caroline embodies everything HELIOS stands for—grit, discipline, and a relentless drive to improve,' said Bill Near, CEO of HELIOS. 'Together, we're not only advancing performance—we're helping lead a new chapter in women's hockey where every athlete has the opportunity to be seen, measured, and developed on their own terms.' As the women's game continues to rise, this collaboration marks a pivotal step toward a more equitable, empowered future—on and off the ice. About HELIOS HELIOS provides advanced wearable performance analytics for ice hockey, empowering coaches, players, and parents with objective, actionable insights. Trusted across elite youth programs, high schools, and national teams, HELIOS is redefining how athletic development is measured and achieved. About Caroline Harvey Caroline Harvey, a standout defender for the U.S. Women's National Team and the University of Wisconsin, led her team to three consecutive National title games with two NCAA championships (2023, 2025). She was the first UW defender to score 63 points in a season, earning Patty Kazmaier top-3 finalist honors and back-to-back WCHA Defender of the Year awards. Internationally, she was named Best Defender at the 2023 and 2025 Women's World Championships (gold medals) and won Olympic silver with Team USA in Beijing 2022.
National Post
09-07-2025
- Business
- National Post
HELIOS and Caroline Harvey Partner to Advance Equity and Innovation in Women's Hockey
Article content Sorry, your browser doesn't support embedded videos. Article content PORTSMOUTH, N.H. — HELIOS, the leading wearable performance platform in ice hockey, proudly announces a new partnership with Caroline Harvey—Olympic medalist, World Champion, and two-time NCAA National Champion—to help close the long-standing gap in sport science and technology for female athletes. Article content As women's sports experience unprecedented growth in participation, viewership, and investment, performance tools and research have yet to catch up. Most data standards and development models are still based on men. For female athletes, especially in hockey, that means training without a complete picture—and often without the tools to reach their full potential. Article content Caroline Harvey is helping to change that. Article content A generational talent with a relentless work ethic, Harvey is redefining what excellence looks like in women's hockey. From breaking records at Wisconsin to leading Team USA to multiple gold medals on the world stage, she represents not just dominance, but progress. Now, by teaming up with HELIOS, she's taking that progress off the ice—and into the broader future of the sport. Article content 'I've always strived to play at the highest level and be at my best,' said Harvey. 'But it's not just about my journey—it's about making sure the next generation has the tools, the data, and the support they need to pursue theirs.' Article content This partnership signals a bold commitment from HELIOS to accelerate that change. In an industry where women's sports have historically been underfunded and underserved by research, Harvey and HELIOS are working to flip the script—bringing visibility, innovation, and investment to where it's long been overdue. Article content 'Caroline embodies everything HELIOS stands for—grit, discipline, and a relentless drive to improve,' said Bill Near, CEO of HELIOS. 'Together, we're not only advancing performance—we're helping lead a new chapter in women's hockey where every athlete has the opportunity to be seen, measured, and developed on their own terms.' Article content As the women's game continues to rise, this collaboration marks a pivotal step toward a more equitable, empowered future—on and off the ice. Article content About HELIOS Article content HELIOS provides advanced wearable performance analytics for ice hockey, empowering coaches, players, and parents with objective, actionable insights. Trusted across elite youth programs, high schools, and national teams, HELIOS is redefining how athletic development is measured and achieved. Article content About Caroline Harvey Article content Caroline Harvey, a standout defender for the U.S. Women's National Team and the University of Wisconsin, led her team to three consecutive National title games with two NCAA championships (2023, 2025). She was the first UW defender to score 63 points in a season, earning Patty Kazmaier top-3 finalist honors and back-to-back WCHA Defender of the Year awards. Internationally, she was named Best Defender at the 2023 and 2025 Women's World Championships (gold medals) and won Olympic silver with Team USA in Beijing 2022. Article content Article content Article content Article content Article content Contacts Article content Media Contact Article content HELIOS Article content Article content Article content
