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Parker Institute Showcases Breakthroughs in Immunotherapy at ASCO 2025 as CEO Dr. Karen Knudsen Receives Prestigious Honor

Parker Institute Showcases Breakthroughs in Immunotherapy at ASCO 2025 as CEO Dr. Karen Knudsen Receives Prestigious Honor

Business Wire29-05-2025
CHICAGO--(BUSINESS WIRE)--As the global oncology community gathers for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30–June 3), the Parker Institute for Cancer Immunotherapy (PICI) is demonstrating how bold science, accelerated through collaborative networks, can drive meaningful progress where patients need it most. At a pivotal moment when scientific breakthroughs in immunotherapy are arriving alongside heightened pressure for faster, smarter impact, PICI's integrated model shows how to compress timelines from discovery to patient care.
PICI's presence spans more than 50 presentations including 16 oral sessions, 30+ poster sessions, 10 e-papers and a featured clinical science symposium. This volume reflects not only the strength of the PICI network but also a unique ability to support promising work early and help carry it across the finish line, from foundational discoveries to practice-changing trials.
Glioblastoma Breakthroughs: New Hope for Cancer's Most Formidable Challenge
After decades of limited progress in glioblastoma, where median survival has hovered around one year, multiple PICI-supported teams are reporting clinical responses that suggest the field may be turning a corner. These advances demonstrate how collaboration, persistence and innovation can converge on even the most intractable problems:
Stanford Medicine researchers achieved median overall survival of 14.6 months in recurrent glioblastoma patients using B7H3 CAR T cells delivered directly to the brain via dual Ommaya reservoirs. The Phase 1 study established a recommended Phase 2 dose and demonstrated manageable inflammation using IL-1 blockade, offering a tangible advance in a cancer where meaningful clinical progress has long remained elusive. (Crystal Mackall, MD, Director of the PICI Center at Stanford; Michelle Monje, MD, PhD — Abstract #2018)
University of Pennsylvania investigators reported tumor shrinkage in 85% of evaluable patients using bivalent CAR T-cell therapy targeting EGFR and IL13Rα2 in recurrent glioblastoma. Delivered into the cerebroventricular space without lymphodepletion, the engineered T cells persisted in cerebrospinal fluid and blood for up to one year, marking an encouraging step toward sustained response and long-term disease management. (Carl June, MD, Director of the PICI Center at Penn; Donald O'Rourke, MD — Abstract #102)
UCSF and Memorial Sloan Kettering researchers identified more than 700 glioma-specific, splice-derived neoantigens using the SNIPP antigen discovery platform. These targets elicited CD8+ T-cell responses in vitro and many were conserved across tumors, opening the door to scalable, potentially off-the-shelf TCR-based therapies. (Hideho Okada, MD, PhD, UCSF — Abstract #2519)
Leadership Recognition: PICI CEO Receives ASCO's Highest Honor
Dr. Karen Knudsen, PICI's CEO, will receive the Allen S. Lichter Visionary Leader Award during ASCO's opening session, recognizing a career spent building bridges from bench to patient and helping reshape how academic institutions, nonprofits and companies move from insight to implementation. Saturday, May 31, 9:45 AM–12:00 PM CDT, Room N - Hall B1
Dr. Knudsen will also join Endpoints News for a live discussion on research acceleration, regulatory pace and how PICI's model aligns research, policy and investment with the realities facing patients today. Wednesday, June 4, 10:35 AM CDT, Endpoints Stage
Network-Wide Impact: Where Discovery Meets Delivery
PICI-supported science appears across the ASCO agenda, tackling critical questions in high-burden cancers through studies connected by a framework that enables speed, coordination and clinical relevance. These presentations reflect a hallmark of the PICI approach: compressing the distance between new insight and patient impact, often turning early-stage ideas into clinical action within just a few years.
Melanoma Advances
DREAMseq Final Results: Optimal treatment sequencing in BRAF-mutant metastatic melanoma (Jedd Wolchok, MD, PhD, Weill Cornell; Antoni Ribas, MD, PhD, UCLA — Abstract #9506)
Quadruple Immunotherapy: IL-6 blockade combined with checkpoint inhibitors in advanced melanoma (F. Stephen Hodi, MD, Dana-Farber — Abstract #9510)
Neoadjuvant Strategy: Pembrolizumab in clinical stage IIB/C melanoma (Alexander Huang, MD, University of Pennsylvania — Abstract #9502)
Prostate Cancer Innovation
COMRADE Trial: Olaparib plus radium-223 in castration-resistant prostate cancer with bone metastases (Eliezer Van Allen, MD, Dana-Farber — Abstract #5007)
C3NIRA Trial: Triplet chemo-immunotherapy induction followed by PARP inhibitor maintenance (Padmanee Sharma, MD, PhD, MD Anderson — Abstract #5008)
Breast and Lung Cancer Precision Strategies
NeoSTAR Trial: Response-guided neoadjuvant sacituzumab govitecan plus pembrolizumab in early triple-negative breast cancer (Elizabeth Mittendorf, MD, PhD, Dana-Farber — Abstract #511)
ADRIATIC Correlatives: Genomic analysis of long-term responders in limited-stage small cell lung cancer (David Barbie, MD, Dana-Farber — Abstract #8014)
Translational Platforms
INCIPIENT Trial: CARv3-TEAM-E immunological correlates in recurrent glioblastoma (Marcela Maus, MD, PhD, Massachusetts General Hospital — Abstract #2008)
BRCA1/2 DNA Vaccines: Plasmid-based immunotherapy platform with and without IL-12 (Robert Vonderheide, MD, DPhil, University of Pennsylvania — Abstract #10505)
About the Parker Institute for Cancer Immunotherapy
The Parker Institute for Cancer Immunotherapy (PICI) accelerates breakthrough immune therapies from discovery to patient impact through a collaborative network of the nation's top cancer centers. Founded in 2016 through the vision of Sean Parker, PICI unites leading institutions in a translational engine built for speed, coordination and clinical relevance. Unlike traditional research models, PICI goes beyond discovery by actively advancing promising innovations through clinical testing, company formation, incubation and commercialization.
PICI supports high-risk, high-reward science with shared goals, data and infrastructure, helping compress timelines from laboratory discovery to patient access. The institute has supported more than 1,000 investigators across its network and created a portfolio of 17 biotech ventures with over $4 billion in raised capital. By integrating scientific excellence with entrepreneurial execution, PICI is reimagining how cures are made and accelerating their path to the people who need them most.
Learn more at parkerici.org. Follow #PICIatASCO for updates throughout the meeting.
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The #1 Late-Night Snack for Better Sleep, According to Dietitians
The #1 Late-Night Snack for Better Sleep, According to Dietitians

Yahoo

time42 minutes ago

  • Yahoo

The #1 Late-Night Snack for Better Sleep, According to Dietitians

Reviewed by Dietitian Alyssa Pike, RDNKey Points Dietitians recommend the Golden Milk Shake as the No. 1 late-night snack for better sleep. The Golden Milk Shake contains trypophan and vitamin D—both thought to impact our sleep—and no added sugars. Strategies for better sleep include eating a balanced diet, avoiding too much caffeine and creating a bedtime doesn't love a good night of restorative sleep? Sleep is the foundation of health and is arguably one of the most important practices for a healthy lifestyle. When it comes to late-night snacks, you may be wondering if there are better choices to promote a good night's rest. Turns out, what you choose to eat (and what you avoid) in the hours before bed can make a difference. 'A heavy, late-night snack tells your system to shift into digestion mode, not rest mode,' says Stacy Lofton, MS, RDN. Instead, she recommends choosing foods that digest easily within an hour or two before bed. This is why our favorite late-night snack for better sleep is our Golden Milk Shake. 'It blends banana and milk, both sleep-friendly, with a touch of turmeric and cinnamon for warmth and anti-inflammatory support,' says Taiyyibah Moughal, RD, CDN, ISAK-1. Learn more about why this shake is our top pick to help you wind down and sleep well. Why Our Golden Milk Shake is the #1 Late-Night Snack Contains Tryptophan Tryptophan is an essential amino acid found in a variety of foods from nuts and seeds to meats and dairy products. The Golden Milk Shake is made with reduced-fat milk, a known source of tryptophan in the diet. Tryptophan is involved in the production of melatonin which is involved in the sleep-wake cycle. Additionally, the combination of protein and carbohydrates aids in the transport of tryptophan to the brain across the blood-brain barrier where it plays a role in the production of serotonin and melatonin. Source of Vitamin D Fortified dairy products that contain vitamin D are one of the few foods in the standard American diet that contribute a significant amount of this essential nutrient. Vitamin D status has also been associated with sleep regulation and not getting enough may increase the risk for sleep-related issues. There are multiple theories as to why vitamin D is thought to influence sleep–one is its involvement in melatonin production. While a Golden Milk Shake won't contribute 100 percent of your daily vitamin D needs, it will provide another opportunity to up your intake. No Added Sugar The Golden Milk Shake contains no added sugar and instead relies on sweetness from ripe bananas and a touch of vanilla extract. Diets that contain too much added sugar, particularly in the form of sugar-sweetened beverages, are associated with poor sleep quality. The Dietary Guidelines for Americans recommend no more than ten percent of calories come from added sugar per day. Just the Right Portion Avoiding heavy snacks before bedtime is recommended to prevent you from feeling overly full prior to sleep. Nutritious snacks that offer just enough calories to help you feel satisfied are the way to go when it comes to sleep-promoting choices. 'Lighter, nutrient-rich snacks like banana and milk—or something with complex carbs and protein—can help you feel settled without feeling too full,' says Moughal. If you need to adjust the portion size of the Golden Milk Shake, we recommend cutting it half and saving the rest for the following day. Strategies for Better Sleep Eat a Balanced Diet 'A balanced, plant-forward diet full of fruits, veggies, whole grains, legumes, and healthy fats provides the micronutrients (like magnesium and vitamin B6) that support more restful and less interrupted sleep,' says Moughal. 'Some of the most sleep-supportive foods include tart cherries, kiwifruit, milk, and fatty fish,' says Moughal. 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'Eating too close to bedtime can disrupt digestion and make it harder to fall or stay asleep,' Smaller portions of nutrient-dense foods should be the primary choice to prevent from feeling overly full before sleep. Skip the Caffeine and Alcohol 'Caffeine and alcohol are major culprits when consumed too close to bedtime—caffeine can delay sleep onset, while alcohol may disrupt deep sleep,' says Moughal. Skip the afternoon cup of coffee if you want to fall asleep easily and limit your happy hour drinks for better rest. These practices can help you wake up feeling refreshed and with more energy the following day. Be Strategic About Fluids Drinking too much, too close to bedtime can leave you running to the bathroom at 3am. Instead, Moughal recommends that you stay well-hydrated during the day but taper fluids in the evening to avoid overnight bathroom trips. Create a Routine 'Creating a wind down routine after a busy day will help prepare your brain for sleeping,' says Ashley Q. Lombardi MS, RDN. She recommends putting your phone in another room for the night if you can. 'Getting ready for bed with a book, bath, or some classic music will give your body the opportunity to relax so that you can fall asleep,' she says. Our Expert Take If you're looking for a sleep-friendly late-night snack, we suggest our Golden Milk Shake thanks to the tryptophan and serotonin found in the combination of dairy and banana. The Golden Milk Shake is also naturally sweetened without added sugar, making it a healthier choice to end your day. Cheers to a good night's rest! Read the original article on EATINGWELL

Bicycle Therapeutics Reports Recent Business Progress and Second Quarter 2025 Financial Results
Bicycle Therapeutics Reports Recent Business Progress and Second Quarter 2025 Financial Results

Business Wire

timean hour ago

  • Business Wire

Bicycle Therapeutics Reports Recent Business Progress and Second Quarter 2025 Financial Results

CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle ®) technology, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate updates. 'We continue to execute on our strategy, which is grounded in scientific rigor and focused on fulfilling our mission to develop next-generation precision-guided therapeutics that have the potential to help patients live longer and live well,' said Bicycle Therapeutics CEO Kevin Lee, Ph.D. 'We are energized by the progress we are making across our pipeline, and with this momentum, we are pleased to welcome our new Research and Innovation Advisory Board members, as well as new Board member Charles Swanton, to further our innovation and strategic growth.' Dr. Lee continued: 'As we advance our various pipeline programs that hold strong potential for changing the treatment paradigm for patients with cancer and creating value for shareholders, Bicycle remains committed to disciplined capital allocation. Today we announced organizational streamlining efforts that provide us with operational flexibility to deliver potentially value-generating datasets while strengthening our financial position in uncertain market conditions. Saying goodbye to talented team members is very difficult, and we sincerely thank them for their dedication to our company. We believe Bicycle is strongly positioned to realize our strategic priorities and milestones and look forward to providing key program updates over the second half of this year.' Second Quarter 2025 and Recent Events Presented additional human imaging data for an early Bicycle Radioconjugate ® (BRC ®) molecule targeting MT1-MMP at the American Association for Cancer Research (AACR) Annual Meeting 2025. A poster presentation included new data from a second patient who underwent MT1-MMP-PET/CT imaging that build on previously announced data. Altogether, the data continue to validate the potential of MT1-MMP as a novel cancer target and demonstrate the positive properties of BRC molecules for radiopharmaceutical imaging. Imaging data from these two patients are representative of the data generated to date in 12 out of 14 patients with various solid tumors. Bicycle Therapeutics continues to advance its emerging BRC pipeline, with initial EphA2 human imaging data expected in 2H 2025 and company-sponsored clinical trials planned for 2026. Presented two abstracts highlighting the development of Bicycle ® Drug Conjugate (BDC ®) zelenectide pevedotin for metastatic urothelial cancer (mUC) at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting. The abstracts outlined previously disclosed topline combination data for zelenectide pevedotin plus pembrolizumab in first-line mUC from the Phase 1/2 Duravelo-1 trial and provided an overview of the ongoing Phase 2/3 Duravelo-2 registrational trial for zelenectide pevedotin in mUC. Bicycle Therapeutics is on track to provide an update on dose selection from the Duravelo-2 trial and the accelerated approval pathway for zelenectide pevedotin in mUC following a meeting with the U.S. Food and Drug Administration planned for 4Q 2025. Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer (NSCLC) open and actively recruiting patients. Duravelo-4 is Bicycle Therapeutics' second trial to leverage NECTIN4 gene amplification as a biomarker for patient selection and to expand the development of zelenectide pevedotin for additional solid tumors. With several trials underway assessing the potential for zelenectide pevedotin to treat mUC, breast cancer and lung cancer, the company has decided to pause the previously announced Phase 1/2 Duravelo-5 trial in multiple tumors. Expanded Board of Directors with the addition of Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP, current chair of Bicycle Therapeutics' Clinical Advisory Board. Dr. Swanton leads the Cancer Evolution and Genome Instability Laboratory at the Francis Crick Institute. His research focuses on how tumors evolve over space and time, developing an understanding of branching evolutionary histories of solid tumors, processes that drive cancer cell-to-cell variation and the impact of cancer diversity on effective immune surveillance and clinical outcomes. Dr. Swanton is a fellow of the Royal Society, a fellow of the Royal College of Physicians and a fellow of the Academy of Medical Sciences. He completed his M.D. and Ph.D. training at the Imperial Cancer Research Fund Laboratories. Formed Research and Innovation Advisory Board (RAB) to support scientific advancement and strategic growth across preclinical programs. The RAB replaces Bicycle's Scientific Advisory Board. Inaugural RAB members include: Jose-Carlos Gutierrez-Ramos, Ph.D., is a director on the Bicycle Therapeutics Board of Directors. He also serves as the chief science officer at Danaher Corporation, leading the Danaher Innovation Centers and the Danaher Scientific Advisory Board. Previously, Dr. Gutierrez-Ramos was head of global drug discovery at AbbVie Inc., group senior vice president of biotherapeutics research and development (R&D) at Pfizer Inc., and senior vice president and CEDD head of immuno-inflammation at GlaxoSmithKline plc. He was also the founding CEO and president of Repertoire Immune Medicine, where he built and led a team focused on decoding the human immunome. Prior to that, he served as president and CEO of Synlogic, Inc. Dr. Gutierrez-Ramos earned a Ph.D. from the immunology department of the Center for Molecular Biology at the Universidad Autonoma de Madrid, and a B.S., summa cum laude, in chemistry with a minor in biochemistry from the Universidad Complutense de Madrid. Jason Lewis, Ph.D., is the Emily Tow Chair at Memorial Sloan Kettering Cancer Center (MSKCC) and currently serves as the deputy director at the Sloan Kettering Institute, overseeing the Office of Scientific Education and Training. He is also the scientific director of the Radiochemistry and Molecular Imaging Probe Core Facility at MSKCC. Dr. Lewis is a laboratory head in Sloan-Kettering Institute's molecular pharmacology program and serves as a professor at the Gerstner Sloan-Kettering Graduate School of Biomedical Sciences and at Weill-Cornell Medical College. He earned a Ph.D. in biochemistry from the University of Kent and an M.S. and B.S. in chemistry from the University of Essex. Robert Lutz, Ph.D., is a consultant/advisor to biotech and pharma with more than 30 years of experience with a significant focus on the development of antibody-drug conjugates (ADCs). He currently serves as chief scientific officer of Iksuda Therapeutics and is a board member and chief development officer of Synthis Therapeutics. Prior to his consulting practice, Dr. Lutz was vice president of translational research and development at ImmunoGen, where he was responsible for the advancement of multiple ADC programs, including KADCYLA ® (ado-trastuzumab emtansine), the first ADC to be approved for solid tumor indications, and ELAHERE ® (mirvetuximab soravtansine). He earned a Ph.D. in biochemistry from Brandeis University and a B.S. in biochemistry from the University of New Hampshire. Michael Hofman, MBBS, FRACP, FAANMS, FICIS, GAICD, is a nuclear medicine physician and professor at the Sir Peter MacCallum Department of Oncology at the University of Melbourne in Australia. His research has been instrumental in advancing PSMA PET imaging and PSMA radioligand therapy, helping to revolutionize the diagnosis and treatment of prostate cancer. He was named Australia's top researcher in nuclear medicine, radiotherapy and molecular imaging in both 2024 and 2025. Professor Hofman leads the PET/CT program and the Prostate Cancer Theranostics and Imaging Centre of Excellence at Peter MacCallum Cancer Centre. He earned a degree in medicine and surgery from Monash University in Australia and undertook a PET/CT fellowship at St. Thomas' Hospital in London. Welcomed Michael Method, M.D., as senior vice president of clinical development. Dr. Method is an academic and clinical gynecologic oncologist with extensive drug development experience. He most recently served as a senior vice president of clinical development at Karyopharm Therapeutics, Inc., after his time as an executive medical director at ImmunoGen, Inc. where he led global clinical development for gynecologic and female malignancies. Previously, Dr. Method was a senior medical advisor for global medical affairs at Eli Lilly, focused on breast cancer. He earned his M.D. and MPH from Northwestern University, and his B.S. in biochemistry and MBA from the University of Notre Dame. Participation in Upcoming Investor Conferences Bicycle Therapeutics management will participate in the following investor conferences in September: Cantor Global Healthcare Conference on Thursday, Sept. 4; fireside chat at 3:55 p.m. ET Morgan Stanley 23 rd Annual Global Healthcare Conference on Tuesday, Sept. 9; fireside chat at 7:45 a.m. ET Live webcasts of the fireside chats will be accessible in the Investor section of the company's website at Archived replays of the webcasts will be available following the fireside chat dates. Second Quarter 2025 Financial Results Cash and cash equivalents were $721.5 million as of June 30, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities. R&D expenses were $71.0 million for the three months ended June 30, 2025, compared to $40.1 million for the three months ended June 30, 2024. The increase in expense of $30.9 million was primarily due to increased clinical program expenses for zelenectide pevedotin development, increased discovery, platform and other expenses, and increased personnel-related costs, offset by decreased clinical program expenses for Bicycle Tumor-Targeted Immune Cell Agonist ® (Bicycle TICA ®) molecules as well as higher U.K. R&D tax credits period over period. General and administrative expenses were $18.5 million for the three months ended June 30, 2025, compared to $15.9 million for the three months ended June 30, 2024. The increase in expense of $2.6 million was primarily due to increased personnel-related costs, as well as increased professional and consulting fees. Net loss was $79.0 million, or $(1.14) basic and diluted net loss per share, for the three months ended June 30, 2025, compared to net loss of $39.8 million, or $(0.77) basic and diluted net loss per share, for three months ended June 30, 2024. In recognition of the evolving macroeconomic environment and the importance of preserving capital, Bicycle Therapeutics is implementing a workforce reduction and taking other steps to optimize its operations and extend the company's expected financial runway. These strategic cost realignment efforts are being implemented to prioritize potentially high-impact, value-generating programs, which include the advancement of zelenectide pevedotin, BT5528, next-generation Bicycle ® Drug Conjugates and the company's wholly owned pipeline of Bicycle ® Radioconjugates. Bicycle Therapeutics anticipates total operational savings of approximately 30% over the course of the financial runway period. These actions are expected to extend the financial runway into 2028 and strengthen the company's ability to weather continued market uncertainty as it advances clinical programs through key milestones. About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle ® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle ® Drug Conjugate (BDC ®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist ® (Bicycle TICA ®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle ® Radioconjugates (BRC ®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle ® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the validation of MT1-MMP as a cancer target and BRC molecules having positive properties for radiopharmaceutical imaging; the initiation of new clinical trials, the progress of Bicycle's ongoing clinical trials and the timing of EphA2 human imaging data and updates on dose selection in the Duravelo-2 clinical trial and accelerated approval pathway; the outcome of Bicycle's strategic cost realignment efforts and Bicycle's expected financial runway; and the use of Bicycle Therapeutics' technology through various partnerships to develop therapies for diseases beyond oncology. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you 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 these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics' product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its cost realignment efforts; the risk that Bicycle's projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics' actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled 'Risk Factors' in Bicycle Therapeutics' Annual Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 1, 2025, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Balance Sheets Data (In thousands) (Unaudited) June 30, December 31, 2025 2024 Cash and cash equivalents $ 721,451 $ 879,520 Working capital 726,840 861,375 Total assets 832,184 956,868 Total shareholders' equity 668,915 793,060 Expand

Could GPL-1 weight loss soon come in pill form? What we know
Could GPL-1 weight loss soon come in pill form? What we know

USA Today

time13 hours ago

  • USA Today

Could GPL-1 weight loss soon come in pill form? What we know

Eli Lilly, the pharmaceutical company behind GLP-1 injection Zepbound, is working to bring its weight loss drug to the market in pill form. In an Aug. 7 earnings call, Eli Lilly CEO David Ricks told investors that the company plans to submit the drug, orforglipron, to the FDA for approval by the end of the year. Dan Skovronsky, chief scientific officer and president of Lilly Immunology, said that the company was "very pleased" with the safety and efficacy of orforglipron as seen in trials so far. Unlike injectable obesity drugs, which are peptides designed to mimic the appetite-controlling GLP-1 hormone, orforglipron is a small molecule pill that is easier to manufacture and package, said Kenneth Custer, president of Lilly's cardiometabolic health division. Lilly views the once-daily pill as a promising alternative to injections that could be used for early intervention and long-term disease management, Custer said. Here's what we know so far about the proposed weight loss pill. What have the trials found? In a clinical trial, the company's weight loss pill resulted in a nearly 12% weight loss at 72 weeks for participants who took the highest dose of the medication. On average, participants lost 7.8% to 12.4% of their body weight, and 40% of people on the highest dose lost more than 15%, Eli Lilly reported. The most commonly reported side effects included gastrointestinal issues consistent with other GLP-1s, such as nausea, vomiting, and diarrhea. Five to ten percent of patients discontinued the drug across doses, the company said, which was one of two late-stage trials the drug must pass before being submitted for federal approval. While Eli Lilly saw the results as indicators of success, investors on the call expressed concerns. Some had hoped that its efficacy would more closely resemble that of existing injections on the market — which can result in up to a 20% body weight loss — while others noted the trial drop-out rate of 12% due to side effects or personal reasons. When will the weight loss pill hit the market? While there is not yet an official timeline, Eli Lilly executives have said they plan to submit orforglipron for federal approval by the end of the year. Reviews of New Drug Approval submissions to the FDA usually last one to two years before a drug is greenlit for manufacturing. Contributing: Alysa Guffey, Indianapolis Star; Reuters

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