Latest news with #JohnLeonard
Yahoo
a day ago
- Sport
- Yahoo
John I. Leonard football, rostering just 25 players, will measure wins differently in 2025
MIAMI GARDENS – John I. Leonard's football representatives stepped into the land of giants at the Miami Dolphins-sponsored High School Media Day on Aug. 9 at Hard Rock Stadium. Schools from Broward, Dade and Palm Beach counties were in attendance with illustrious football schools such as Chaminade Madonna, St. Thomas Aquinas, Miami Western, Columbus, and many others. Some clubs came with an army of a dozen players, 6-foot-5, 300-pound giants lurking in the hallways of Hard Rock Stadium. And then in sauntered the lightly-regarded Lancers with their head coach Austin Van Es, surrounded by three players - the 5-7, 265 pound offensive lineman Solomon Yool, wide receiver/cornerback/punt returner Lumensley Joseph and running back Latrell Johnson. Leonard's trio weren't exactly the biggest guys in the room darting through various photo shoots. But the Lancers players talked big because that's what you do at 0-0. Never hailed a traditional football school, John I. Leonard posted a 1-9 record in 2024 – the lone victory against winless Olympic Heights. 'It is not (a big football school) but it can always be one,'' Yool said. 'If these new guys produce to their highest ability and the mentality is right, I'm all here for it. As a senior, it's my job for the mentality to be right and they become disciplined. As they grow, they're already in the works of becoming a D-I player.'' Watch the best high school football games in Florida Under the lights: An essential guide to Palm Beach County high school football More: Palm Beach Post Sports will be hosting an NIL Forum The roster stands at just 25 players, meaning several will play offense and defense. Van Es starts his fifth season after 15 seniors left for graduation. It's a junior-dominated roster – 15 of them. 'It's trying to get kids interested in football,'' Van Es said of the unique challenges facing Leonard. 'It's not the most popular sport in our school. We usually have more kids come out for soccer and basketball. It's time to build interest and get more of a love for the sport.'' There were signs of progress in the offseason workouts but there is a ways to go. Yool, who always sees the glass half full, said, 'The most improved part is our mentality and becoming more disciplined. This whole summer, every day, we were in weight room testing our limits so when it's time for the games we're ready to put our all into it.'' However, Joseph said dedication still has to elevate in Greenacres. 'I'll be honest when I say this,'' Joseph said of Leonard's poor records. 'It's been a lack of effort people put in. Sometimes we have less than double digits at practice. It's really sad. During summer workouts, sometimes 20 guys, then sometimes single digits. I'm like what? We got to put in more work.'' But Joseph added, 'I know we're going to do better than last season, even though we lost our seniors. We're still going to be better through God.'' It may take a miracle worker to squeeze a 2025 winning record out John I. Leonard, which hosts Forest Hill in its season opener Aug. 22. The Lancers didn't play a preseason classic game. Es, who played football in Greenacres but at Summit Christian, was realistic. 'Right now our goal is to go week to week and see how we progress each week individually and as a team and see where our growth is at the end of the season," the coach said. 'We have a lot of young guys. Our biggest goal is see how much they improve from Week 1 to Week 10." When losing occurs weekly, morale can go low so Es has to find ways to keep spirits flowing. 'We got to get them to understand mentally, sometimes it's not about what your record is at the end of the season,'' Van Es said. 'Our success may look like improvement. Are we getting better from Week 1? Are we dominating the line of scrimmage? We have our own little milestones we set. Success might look different for us. It might not be in our record but how we grow and improve.'' For one, Yool doesn't want to be talking about defeats. He feels the talent is there but not always a football mentality found in other schools. 'Those people come out for football and think it's all laughs and giggles and think they'll start or play,' Yool said. 'When they actually go through our practices, their weak mentality stops them and they start quitting or not showing up.'' Yool is one of eight seniors – as serious-minded about the game as anyone in Palm Beach County. 'He's going to be one our key lineman on the offensive and defensive line,''' Van Es said. 'He's going to be our anchor offensively – center, guard, whatever we need. We want him to create chaos and make plays in the backfield (on defense)." Joseph will make an impact in all phases – offense, defense, special teams. Ther other wide receiver is junior Camdyn McCully. Sophomores Matthew Alvarez and Caevian Miller will see time at quarterback and defensive back. Joseph understands the supreme dedication it takes to wear the Leonard jersey proudly. 'Discipline makes it,'' Joseph said. 'I really feel like people just think they can walk in and play football and that's it. It's a physical sport. You got to go up and above.'' With the inexperience at quarterback, the defense looks to be the strong point. 'Our offense is going to have to play a lot better than the previous years,'' Van Es. 'We need teamwork." As Yool posed for pictures among the Goliaths from other high-school squads, he said before leaving the Dolphins stadium, 'Whatever happened in the past is in the past for a reason. You can't it let effect your future." Eric J. Wallace is deputy sports editor for The Palm Beach Post. He can be reached at ejwallace@ Discount for NFHS Network through USA Today USA TODAY Network-Florida readers can get a 25% discount on a yearly NFHS pass in 2025. Use promo code USATODAY25 when you go through our NFHS Network link before Sept. 7 to see top high school football action. This article originally appeared on Palm Beach Post: John I. Leonard football team making the best of small roster in 2025
Yahoo
07-08-2025
- Business
- Yahoo
Intellia Therapeutics Announces Second Quarter 2025 Financial Results and Highlights Recent Company Progress
Enrollment in the global Phase 3 MAGNITUDE trial of nexiguran ziclumeran (nex-z) in ATTR with cardiomyopathy (ATTR-CM) continues to track ahead of projections; Tracking to enroll at least 650 patients cumulatively by year-end Expanding total enrollment of the MAGNITUDE study to approximately 1,200 patients, subject to health authority review, with no expected impact on previous projected enrollment or financial runway Expect to complete enrollment by first half 2026 in the global Phase 3 MAGNITUDE-2 study evaluating nex-z in hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN) Expect to complete randomization in the global Phase 3 HAELO study of lonvoguran ziclumeran (lonvo-z) in hereditary angioedema (HAE) during the third quarter Additional data from the Phase 1/2 study evaluating lonvo-z in HAE and longer-term data from the Phase 1 study evaluating nex-z in ATTR-CM and ATTRv-PN expected in the second half of 2025 Ended the second quarter with approximately $630.5 million in cash, cash equivalents and marketable securities; Expected to fund operations into the first half of 2027 and into the anticipated first commercial launch CAMBRIDGE, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today reported operational highlights and financial results for the second quarter ended June 30, 2025. 'We are exceeding many of our internal expectations,' said Intellia President and Chief Executive Officer John Leonard, M.D. 'The enthusiasm from both patients and physicians for Intellia's late-stage programs has resulted in strong enrollment numbers that allow us to plan to enhance the Phase 3 MAGNITUDE trial in ATTR-CM and accelerate completion of the Phase 3 HAELO study in HAE ahead of our original plans. We are full steam ahead in achieving our mission of getting one-time therapies to more patients.' Second Quarter 2025 and Recent Operational Highlights Hereditary Angioedema (HAE) Lonvoguran ziclumeran (lonvo-z, also known as NTLA-2002): Lonvo-z is a wholly owned, investigational in vivo CRISPR-based therapy designed to knock out the KLKB1 gene in the liver, with the goal of lifelong control of HAE attacks after a single dose. Recruitment ended earlier than expected during the second quarter and the Company now expects to complete randomization in the global Phase 3 HAELO study during the third quarter 2025. Intellia presented three-year follow-up data from the Phase 1 portion of the ongoing Phase 1/2 study after receiving a single dose of lonvo-z. Results were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 on June 15 in Glasgow, United Kingdom. In the Phase 1 portion of the study, a one-time dose of 25 mg (N=3), 50 mg (N=4) or 75 mg (N=3) of lonvo-z was administered via intravenous infusion and plasma kallikrein protein levels were measured along with HAE attacks. At the time of the February 12, 2025 data cutoff, all 10 patients were attack-free and treatment-free for a median of nearly two years. With up to three years of follow-up, a single dose of lonvo-z led to a mean reduction in monthly HAE attack rate of 98% over the study period, compared to pre-treatment baseline. For all 10 patients, deep, dose-dependent and durable reductions in plasma kallikrein protein continued to be observed through the latest assessment. Across all three dose levels, lonvo-z was generally well tolerated and showed a safety profile consistent with earlier data presented at EAACI in 2024. The most frequent adverse events during the study period were infusion-related reactions (IRRs). IRRs were mostly Grade 1 and resolved with all patients receiving the full dose. With up to three years of follow-up, no treatment-emergent serious adverse events were observed, and no treatment-related adverse events were observed during the period following 28 days after dosing. Intellia expects to present additional data from the ongoing Phase 1/2 study in the second half of 2025. The Company is on track to submit a Biologics License Application (BLA) in the second half of 2026. Transthyretin (ATTR) Amyloidosis Nexiguran ziclumeran (nex-z, also known as NTLA-2001): Nex-z is an investigational in vivo CRISPR-based therapy designed to inactivate the TTR gene in liver cells, thereby preventing the production of transthyretin (TTR) protein for the treatment of ATTR amyloidosis. Nex-z offers the possibility of halting and reversing the disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a single dose. Intellia leads development and commercialization of nex-z in collaboration with Regeneron Pharmaceuticals, Inc. ATTR Amyloidosis with Cardiomyopathy (ATTR-CM): Enrollment in the global Phase 3 MAGNITUDE trial is progressing ahead of the Company's projections and the Company is tracking to enroll at least 650 patients cumulatively by year-end. Intellia is amending the MAGNITUDE study to expand enrollment to approximately 1,200 patients from 765 patients, subject to health authority review. Expanding the patient number in the study would provide a more robust dataset, particularly in the stabilizer stratum, which we believe will be very important to patients, clinicians, and payers. This change has no expected impact on previously projected enrollment timelines or the Company's projected cash runway. In May 2025, the Company presented Phase 1 wild-type vs. variant ATTR-CM data at the Heart Failure 2025 Meeting in Belgrade, Serbia. The data showed that nex-z reduced TTR production and showed promise for treating both wild-type (ATTRwt) and variant (ATTRv) ATTR-CM with a favorable safety profile. Absolute TTR levels dropped from 222.4 to 16.5 μg/mL (ATTRwt) and 132.0 to 16.6 μg/mL (ATTRv). Functional capacity and clinical biomarkers were favorably impacted in both patient groups. Evidence of stability or improvement in disease progression markers were observed across both populations at similar rates. The most commonly reported treatment-related adverse events were IRR, which were mild or moderate, and did not result in any discontinuations. Observed liver enzyme abnormalities were not considered serious, were asymptomatic and resolved spontaneously without medical intervention or sequelae. Intellia expects to present longer-term data from ATTR-CM patients in the Phase 1 study in the second half of 2025. The data will include updated measures of clinical efficacy and safety. Hereditary ATTR Amyloidosis with Polyneuropathy (ATTRv-PN): Enrollment is ahead of schedule in the global Phase 3 MAGNITUDE-2 study. Intellia now expects enrollment to be completed in the first half of 2026. In May 2025, the Company presented positive two-year follow-up Phase 1 data in an oral presentation at the 2025 Peripheral Nerve Society (PNS) Annual Meeting in Edinburgh, United Kingdom. Across patients who received a one-time dose of 0.3 mg/kg or higher (n=33), the mean serum TTR reduction by Day 28 was 90% (corresponding mean absolute serum TTR level of 23.8 µg/mL), with levels remaining virtually unchanged through at least 24 months. Among the 18 patients with 24 month mNIS+7 endpoint assessments, 13 showed improvements of ≥ 4 points, which is considered to be a clinically meaningful threshold. Most of the patients in the cohort who had progressed on patisiran improved, and only a single patient among the 18 had a deterioration of ≥ 4. Nex-z was generally well tolerated across all patients and at all dose levels tested. Treatment-related adverse events were consistent with those described for the cardiomyopathy population. In September 2025, the Company will present interim Phase 1 extended data in a symposium at the 5th International ATTR Amyloidosis Meeting for Patients and Doctors in Baveno, Italy. Platform and Company Updates Intellia is pioneering novel CRISPR-based gene editing technologies, such as gene writing and extrahepatic lipid nanoparticle (LNP) delivery technologies, to create highly differentiated in vivo and ex vivo product candidates. The Company's proprietary platform technologies are being researched and developed to expand therapeutics opportunities to support the mission of transforming lives of people with severe diseases, including the possibility of curative genome editing therapeutics. Intellia has expanded its commercial and medical affairs teams to build a strong foundation for commercial readiness. Since the beginning of the year, the company welcomed two key leaders: Jim McNinch, Vice President, U.S. Head of Sales and Ben Newman, Vice President, Commercial Operations, as well as several additional senior leaders with responsibilities for commercial data and field operations, marketing, pricing, patient services, market access, forecasting and medical communications. The company has largely completed the buildout of the commercial and medical affairs leadership teams. Upcoming Events The Company will participate in the following events during the third quarter of 2025: Citi 2025 Biopharma Back to School Conference, Sept. 3, Boston Wells Fargo Health Care Conference, Sept. 4, Boston Bernstein Healthcare Forum, Sept. 23, New York 5th International ATTR Amyloidosis Meeting for Patients and Doctors, Sept. 25-26, Baveno, Italy Second Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $630.5 million as of June 30, 2025, compared to $861.7 million as of December 31, 2024. The decrease in cash, cash equivalents and marketable securities includes approximately $65.0 million of non-recurring cash payments in the first half of 2025 associated with the Company's previously announced portfolio prioritization, workforce reduction, and real estate consolidation. The Company's cash, cash equivalents and marketable securities as of June 30, 2025 are expected to fund operations into the first half of 2027 and into the anticipated first commercial launch. Collaboration Revenue: Collaboration revenue was $14.2 million during the second quarter of 2025, compared to $6.9 million during the second quarter of 2024. The $7.3 million increase was mainly driven by cost reimbursements related to our collaboration with Regeneron Pharmaceuticals, Inc. R&D Expenses: Research and development (R&D) expenses were $97.0 million during the second quarter of 2025, compared to $114.2 million during the second quarter of 2024. The $17.2 million decrease was primarily driven by employee-related expenses, stock-based compensation, research materials and contracted services offset by an increase in the advancement of our lead programs. Stock-based compensation expense included in R&D expenses was $14.1 million for the second quarter of 2025. G&A Expenses: General and administrative (G&A) expenses were $27.2 million during the second quarter of 2025, compared to $31.8 million during the second quarter of 2024. The $4.6 million decrease was primarily related to lower stock-based compensation, offset in part by increased expenses related to the ongoing buildout of our commercial infrastructure. Stock-based compensation expense included in G&A expenses was $8.0 million for the second quarter of 2025. Net Loss: Net loss was $101.3 million for the second quarter of 2025, compared to $147.0 million during the second quarter of 2024. Conference Call to Discuss Second Quarter 2025 Results The Company will discuss these results on a conference call today, Thursday, August 7 at 8 a.m. ET. To join the call: U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call. Please visit this link for a simultaneous live webcast of the call. A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia's website at beginning on August 7 at 12 p.m. ET. About Intellia TherapeuticsIntellia Therapeutics, Inc. (NASDAQ:NTLA) is a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies. Since its inception, Intellia has focused on leveraging gene editing technology to develop novel, first-in-class medicines that address important unmet medical needs and advance the treatment paradigm for patients. Intellia's deep scientific, technical and clinical development experience, along with its people, is helping set the standard for a new class of medicine. To harness the full potential of gene editing, Intellia continues to expand the capabilities of its CRISPR-based platform with novel editing and delivery technologies. Learn more at and follow us @intelliatx. Forward-Looking Statements This press release contains 'forward-looking statements' of Intellia Therapeutics, Inc. ('Intellia' or the 'Company') within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia's beliefs and expectations concerning: the safety, efficacy, success and advancement of its clinical programs for nexiguran ziclumeran or 'nex-z' (also known as NTLA-2001) for transthyretin ('ATTR') amyloidosis and lonvoguran ziclumeran or 'lonvo-z' (also known as NTLA-2002) for the treatment of hereditary angioedema ('HAE') pursuant to its clinical trial applications ('CTA') and investigational new drug application ('IND') submissions, including the expected timing of data releases from its ongoing clinical trials of nex-z and lonvo-z, regulatory feedback, regulatory filings, and the enrollment, dosing and completion of clinical trials, such as completing randomization in the Phase 3 HAELO study in the third quarter of 2025 and submitting a biologics license application ('BLA') for lonvo-z in the second half of 2026, its ability to enroll the Phase 3 MAGNITUDE study and enroll at least 650 patients cumulatively by the end of 2025, its ability to enroll the Phase 3 MAGNITUDE-2 study and complete enrollment in the first half of 2026, its plans to present new data from the ongoing Phase 1/2 study of lonvo-z and longer-term Phase 1 data of nex-z, including updated measures of clinical efficacy and safety, in the second half of 2025, the potential of nex-z to halt and reverse disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a single dose, and the potential of lonvo-z to provide lifelong control of HAE attacks after a single dose; its expectations that expanding the patient number in the Phase 3 MAGNITUDE study would provide a more robust dataset, particularly in the stabilizer stratum, and its belief that such dataset will be very important to patients, clinicians and payers, while having no expected impact on previously projected enrollment timelines or its projected cash runway; its ability to apply novel CRISPR-based gene editing technologies, such as gene writing, and extrahepatic lipid nanoparticle ('LNP') delivery technologies to create highly differentiated in vivo and ex vivo product candidates, including its ability to use those technologies to expand therapeutic opportunities and the timing expectations of advancing such product candidates; its ability to build a strong foundation for commercial readiness through hiring certain senior leadership positions in its commercial and medical affairs organizations; its ability to optimize the impact of its collaborations on its development programs, including, but not limited to, its collaboration with Regeneron Pharmaceuticals, Inc. ('Regeneron') and their co-development programs for ATTR amyloidosis; and its growth as a company and expectations regarding its uses of capital, expenses, future accumulated deficit and financial results, including its ability to fund operations into the first half of 2027 and into the first anticipated commercial launch. Any forward-looking statements in this press release are based on management's current expectations and beliefs 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. These risks and uncertainties include, but are not limited to: risks related to Intellia's ability to protect and maintain its intellectual property position; risks related to Intellia's relationship with third parties, including its contract manufacturers, collaborators, licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to the authorization, initiation and conduct of preclinical and clinical studies and other development requirements for its product candidates, including uncertainties related to regulatory approvals to conduct clinical trials; risks related to the ability to develop and commercialize any one or more of Intellia's product candidates successfully; risks related to the results of preclinical studies or clinical studies not being predictive of future results in connection with future studies; the risk that clinical study results will not be positive; risks related to the potential delay of planned clinical trials due to regulatory feedback or other developments; and risks related to Intellia's collaborations with Regeneron, or its other collaborations not continuing or not being successful. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia's actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in Intellia's most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Intellia's other filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by law. INTELLIA THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (Amounts in thousands, except per share data) Three Months ended June 30, Six Months ended June 30, 2025 2024 2025 2024 Collaboration revenue $ 14,245 $ 6,957 $ 30,872 $ 35,892 Operating expenses: Research and development 97,035 114,207 205,462 226,054 General and administrative 27,206 31,793 56,213 62,884 Total operating expenses 124,241 146,000 261,675 288,938 Operating loss (109,996 ) (139,043 ) (230,803 ) (253,046 ) Other income (expense), net: Interest income 7,402 12,422 16,005 25,054 Change in fair value of investments, net 1,339 (20,354 ) (786 ) (26,419 ) Total other income (expense), net 8,741 (7,932 ) 15,219 (1,365 ) Net loss $ (101,255 ) $ (146,975 ) $ (215,584 ) $ (254,411 ) Net loss per share, basic and diluted $ (0.98 ) $ (1.52 ) $ (2.08 ) $ (2.64 ) Weighted average shares outstanding, basic and diluted 103,732 96,975 103,617 96,238 INTELLIA THERAPEUTICS, INC. CONSOLIDATED BALANCE SHEET DATA (UNAUDITED) (Amounts in thousands) June 30, 2025 December 31, 2024 Cash, cash equivalents and marketable securities $ 630,506 $ 861,730 Total assets 898,894 1,191,015 Total liabilities 183,639 319,059 Total stockholders' equity 715,255 871,956 Investors:Brittany ChavesSenior Manager, Investor Media:Matt CrensonTen Bridge Communicationsmedia@ mcrenson@ 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
15-06-2025
- Business
- Business Upturn
Intellia Therapeutics Announces Positive Three-Year Data from Phase 1 Trial of Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema (HAE) at the European Academy of Allergy and Clinical Immunology Congress
With up to three years of follow-up, a single dose of lonvo-z led to a 98% mean reduction in monthly HAE attack rate in all 10 patients All 10 patients were attack-free and treatment-free for a median of 23 months through the latest follow-up, demonstrating the potential of lonvo-z to become the first one-time therapy for most HAE patients Lonvo-z was well tolerated and continues to demonstrate a favorable safety profile The global Phase 3 HAELO trial of lonvo-z has concluded screening ahead of schedule with more than half screened from U.S. sites; Intellia to provide an update on enrollment in the future CAMBRIDGE, Mass., June 15, 2025 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced three-year follow-up data from the Phase 1 portion of the ongoing Phase 1/2 study in patients with HAE after receiving a single dose of lonvoguran ziclumeran (lonvo-z, also known as NTLA-2002). Results were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held June 13-16 in Glasgow, United Kingdom. 'Today's results underscore the promising potential of Intellia's approach to gene editing therapy – a one-time treatment that was well tolerated and offered a highly differentiated, durable effect for patients suffering from a serious disease,' said Intellia President and Chief Executive Officer John Leonard, M.D. 'Seeing all 10 patients in the Phase 1 portion of this study free from both HAE attacks and chronic therapy at nearly two years of median follow-up is incredibly encouraging. These data fuel our optimism for the outcomes of our ongoing Phase 3 HAELO study, which we expect to report in the first half of 2026, and highlight the strong value we believe it will offer patients, physicians and payers.' 'People living with HAE often report a reduced quality of life because they worry about the likelihood of their next attack, either because they still experience attacks or are reminded of it by their use of chronic therapy,' said Dr. Joshua Jacobs, Medical Director, Allergy and Asthma Clinical Research, Inc. 'Based on the data, it is reasonable to expect lonvo-z could offer patients the potential to be free from both physical HAE attacks and the burden of managing chronic HAE treatment.' In the Phase 1 portion of the study, a one-time dose of 25 mg (N=3), 50 mg (N=4) or 75 mg (N=3) of lonvo-z was administered via intravenous infusion and plasma kallikrein protein levels were measured along with HAE attacks. At the time of the February 12 data cutoff, patients were attack-free and treatment-free for a median of nearly two years. With up to three years of follow-up, a single dose of lonvo-z led to a mean reduction in monthly HAE attack rate of 98% over the study period, compared to pre-treatment baseline. For all 10 patients, deep, dose-dependent and durable reductions in plasma kallikrein protein continued to be observed through the latest assessment. Safety Across all three dose levels, lonvo-z has been well tolerated and continues to demonstrate a favorable safety profile consistent with earlier data presented at EAACI in 2024. The most frequent adverse events during the study period were infusion-related reactions (IRRs). IRRs were mostly Grade 1 and resolved with all patients receiving the full dose. With up to 3 years of follow-up, no treatment-emergent serious adverse events were observed, and no treatment-related adverse events were observed during the period following 28 days after dosing. Clinical Development Plans Intellia's global Phase 3, randomized, double-blind, placebo-controlled HAELO trial is ongoing to assess the safety and efficacy of lonvo-z at the 50 mg dosage. The Company announced today the HAELO trial has successfully completed screening ahead of schedule, with over half of the patients being screened in the United States. The study is no longer recruiting and Intellia will provide an update on enrollment in the future. New and longer-term data from the Phase 2 portion of the ongoing Phase 1/2 study is planned to be presented in the second half of 2025. Intellia expects to submit a biologics license application (BLA) in 2026 to support the Company's plans for a U.S. launch in 2027. For more information on HAELO (NCT06634420), please visit About the Lonvoguran Ziclumeran (lonvo-z, also known as NTLA-2002) Clinical Program Intellia's ongoing Phase 1/2 study is evaluating the safety and efficacy of lonvo-z in adults with Type I or Type II hereditary angioedema (HAE). The Phase 1 portion of the study is an international, open-label study designed to identify the dose level of lonvo-z selected for further evaluation in the Phase 2 portion of the study. Enrollment in both portions of the Phase 1/2 study is complete. Intellia dosed the first patient in the global Phase 3, randomized, double-blind, placebo-controlled HAELO trial in January of 2025. Visit (NCT05120830) for more details. About Lonvo-z Based on Nobel Prize-winning CRISPR/Cas9 technology, lonvo-z has the potential to become the first one-time treatment for hereditary angioedema (HAE). Lonvo-z is an investigational in vivo CRISPR-based gene editing therapy designed to prevent HAE attacks by inactivating the kallikrein B1 ( KLKB1 ) gene, which encodes for prekallikrein, the kallikrein precursor protein. Interim Phase 1/2 clinical data showed dramatic reductions in attack rate, as well as consistent, deep and durable reductions in kallikrein levels. Lonvo-z has received five notable regulatory designations, including Orphan Drug and RMAT Designation by the U.S. Food and Drug Administration (FDA), the Innovation Passport by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), Priority Medicines (PRIME) Designation by the European Medicines Agency, as well as Orphan Drug Designation (ODD) by the European Commission. About Intellia Therapeutics Intellia Therapeutics, Inc. (NASDAQ:NTLA) is a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies. Since its inception, Intellia has focused on leveraging gene editing technology to develop novel, first-in-class medicines that address important unmet medical needs and advance the treatment paradigm for patients. Intellia's deep scientific, technical and clinical development experience, along with its people, is helping set the standard for a new class of medicine. To harness the full potential of gene editing, Intellia continues to expand the capabilities of its CRISPR-based platform with novel editing and delivery technologies. Learn more at and follow us @intelliatx. Forward-Looking Statements This press release contains 'forward-looking statements' of Intellia Therapeutics, Inc. ('Intellia' or the 'Company') within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia's beliefs and expectations concerning: the safety, efficacy, success and advancement of its clinical programs for lonvoguran ziclumeran or 'lonvo-z' (also known as NTLA-2002) for hereditary angioedema ('HAE'), including the ability to successfully complete its global Phase 3 HAELO study; its expectation to present additional data regarding lonvo-z, including reporting outcomes of the Phase 3 HAELO study in the first half of 2026 and presenting new and longer-term data from the Phase 2 portion of the ongoing Phase 1/2 study of lonvo-z in the second half of 2025; and its expectation to be able to support a biologics license application for lonvo-z for the treatment of HAE by 2026 for a U.S. launch in 2027. Any forward-looking statements in this press release are based on management's current expectations and beliefs 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. These risks and uncertainties include, but are not limited to: risks related to Intellia's ability to protect and maintain its intellectual property position; risks related to Intellia's relationship with third parties, including its contract manufacturers, licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; risks related to Intellia's ability to protect and maintain its intellectual property position; risks related to valid third party intellectual property; risks related to Intellia's relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to regulatory agencies' evaluation of regulatory filings and other information related to our product candidates, including lonvo-z; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for our product candidates, including uncertainties related to regulatory approvals to conduct clinical trials, including our ability to complete the Phase 3 HAELO study for HAE; the risk that any one or more of Intellia's product candidates, including lonvo-z, will not be successfully developed and commercialized; and the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies for the same product candidate or Intellia's other product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia's actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in Intellia's most recent annual report of Form 10-K and quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Intellia's other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by law. Intellia Contacts: Investors:Brittany ChavesSenior Manager, Investor Relations [email protected]
Hamilton Spectator
11-06-2025
- General
- Hamilton Spectator
‘The right thing to do'
WE"KOQMA'Q - Pam Marston stood in the sun and watched the children excitedly zoom around both inside the community centre and outside with huge smiles on their faces. The vice-principal of We'koqma'q Mi'kmaw School in the First Nation community along highway 105 in Cape Breton was watching the joy of the activities of the 4th Annual Pride Parade for the community last week.. 'We do this every year to support the community and make sure our students and staff feel loved and included,' she said. 'Because it's the right thing to do.' The parade walk brings together members of the Pride community along with their supportive allies, to celebrate diversity and to continue to encourage respect and inclusion in their interactions with others. It is organized by the We'koqma'q Mi'kmaw School and the community. The school, a K3-12 grade school, has two-spirit and transgender students attending, but Marston stresses that every effort is made to ensure that from the smallest to the eldest student and staff, everyone is treated the same – with dignity and respect. 'In some places, often they (members of the LGTBQ2S community) don't feel welcome and have to hide, but they don't have to do that here.' The parade, that included every student in the school who chose to attend (all of them), began at the school and they walked to the nearby community centre where food, games and a fun photo booth had been set up. Marston noted how happy they all were as they ran from game table to craft table to photo booth inside the centre. She said her community has always been very accepting of different lifestyles and differences among people in general. Marston noted that the Chief and most council members were in attendance and interacting with all the students. Chief John Leonard is one of the people who actually began the event, along with former school principal Joanna Alex, who has since passed away. 'This means a lot to our community,' he said. 'And for me, it's personal because I have a family member in the (gay) community.' He said he is proud of this annual event because it is one of the things he and the director of education (Ms. Alex) began. He happily posed for a photo with several members of the band council, also in attendance. Many parents and community supporters attended the walk and BBQ wearing bright rainbow colours. They look forward to the 5th annual walk next year. We'koqma'q First Nation chief and council were on hand last week for the 4th annual Pride Parade in the small community nestled alongside the Bras d'Or Lakes in Cape Breton. Chief John Leonard said the walk is personal for him as he and a now-deceased principal at the school created it several years ago. Above, back row: Brennan Peters, Stuart Basque, Brandon Poulette, and Gordon Googoo. In front are: Jason Bernard, Chief John Leonard and Stewart Peters. ROSEMARY GODIN/CAPE BRETON POST Error! Sorry, there was an error processing your request. There was a problem with the recaptcha. Please try again. You may unsubscribe at any time. By signing up, you agree to our terms of use and privacy policy . This site is protected by reCAPTCHA and the Google privacy policy and terms of service apply. Want more of the latest from us? Sign up for more at our newsletter page .
Time of India
02-06-2025
- Sport
- Time of India
Florida Panthers set sights on Stanley Cup victory as Charlotte Checkers move toward Calder Cup Final
Florida Panthers (via Getty Images) T he Florida Panthers are pursuing their much-awaited Stanley Cup win and their AHL affiliate, the Charlotte Checkers, are making history on their own in the Calder Cup Playoffs. For the first time since coming together in 2020, both teams are within reach of championship glory—an accomplishment that could replicate an unusual feat unseen in almost 30 years in professional hockey. Charlotte Checkers overwhelm Laval Rocket to sit one win shy of Calder Cup Final undefined The Florida Panthers may not be the only team in the playoffs spotlight, as the Charlotte Checkers are within a win of heading to the Calder Cup Final with a 5-1 thumping of the Laval Rocket in Game 3 of the Eastern Conference Finals. On Sunday, the team effort was visible with Riley Bezeau scoring twice, including one during a four-goal second period, as John Leonard, Will Lockwood, and Sandis Vilmanis also scored to make the game far out of reach for the AHL affiliate Laval Rocket of the Montreal Canadiens. Goaltender Kaapo Kahkonen was again phenomenal with 22 saves, supporting Charlotte to its seventh consecutive playoff victory. The Checkers have now scored 15-4 in this best-of-seven series against Laval. 'Our guys have done it all year,'' Charlotte Checkers head coach Geordie Kinnear said. 'That's a great team,'' Bezeau said. 'They finished first in their division; they're not going to go away, and we know that. We've just got to stick to our game plan and keep going.' If Charlotte sweeps the series at home Tuesday night, and if the Florida Panthers keep their Stanley Cup Final quest alive, the two teams might duplicate a task last accomplished in 1995 when the New Jersey Devils and Albany River Rats captured the Stanley Cup and Calder Cup, respectively. Meanwhile in the Western Conference, the Abbotsford Canucks lead 2-0 against the Texas Stars and the series heads to Austin for Game 3. Also read: Brad Marchand eyes the second Stanley Cup in a career-redefining run with the Florida Panthers As the Florida Panthers eye a Stanley Cup championship, the Charlotte Checkers are forging an equally impressive argument for a Calder Cup Final appearance. If both teams win their respective titles, it would be a historic double victory for the organization, helping to make this year one of the most successful in Florida's hockey history.
