OSF Healthcare now offering scalp cooling for cancer patients
It's called scalp cooling, and it's a first-of-its-kind service being offered in our area.
It's a non-invasive, free treatment designed to reduce hair loss during chemotherapy. It works by lowering the temperature of your scalp down to 65 degrees before, during and after chemo.
Scalp cooling helps cancer patients keep as much of their hair as possible, which in turn, helps their mental health.
Our 2025 Remarkable Women winner, Patricia Cutiletta, had a huge part in bringing this service to our area.
'Well, it has nothing to do with vanity,' Cutiletta said. 'I had an oncologist who said to me, oh, that's for vain people. It's not. It's for people who want to preserve some sense of identity. It's for people who want to continue as much of their normal lifestyle as they can. And it's for people who want something that they can try and control.'
The scalp cooling service is part of OSF Healthcare's START program. Which stands for survive, thrive and recover together.
There's more than just scalp cooling. Patients can also get personalized care to help navigate their 'new normal' with confidence.
Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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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 Wire
2 hours ago
- Business Wire
Precision BioSciences Reports Second Quarter 2025 Financial Results and Provides Business Update
DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet need, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. 'Our team continues to be very disciplined about executing our plans and is making strong progress advancing our clinical stage PBGENE-HBV program while rapidly advancing PBGENE-DMD toward the clinic,' said Michael Amoroso, Chief Executive Officer of Precision BioSciences. 'The early Phase 1 safety and efficacy data for PBGENE-HBV from the first cohort of the Phase 1 ELIMINATE-B trial establishes proof of activity for our novel gene editing approach for chronic Hepatitis B. Our data shows that we have a novel, safe and active drug in all patients treated with a durable effect in one third of patients reinforcing the mechanism of PBGENE-HBV to eliminate cccDNA. We are very pleased with the safety profile demonstrated in Cohorts 1 and 2 which has enabled the Data Monitoring Committee to endorse enrolling Cohort 3 this month to test the next higher dose. Concurrently, we are accelerating the development of our second program, PBGENE-DMD, and were proud to receive both Rare Pediatric Disease and Orphan Drug designations from the U.S. Food and Drug Administration (FDA), underscoring the significant unmet need for new therapeutic options for patients living with DMD.' 'Given the unmet need, opportunity and enthusiasm for PBGENE-HBV and PBGENE-DMD, we are taking proactive steps to invest fully in these two programs while extending our expected cash runway to the second half of 2027 through a significant reduction in our non-program related annual operating expenses. These actions are expected to enable commencement of a Phase 2 study for PBGENE-HBV and a potential pivotal trial for PBGENE-DMD. Our team remains committed to delivering transformative therapies in areas with significant unmet need and, with a longer cash runway, we believe we are now even better positioned to deliver the meaningful clinical data that is expected by patients and shareholders for both of our wholly-owned programs,' added Mr. Amoroso. Wholly Owned Portfolio PBGENE-HBV (Viral Elimination Program): PBGENE-HBV is Precision's wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate the root cause of chronic Hepatitis B, cccDNA, while inactivating integrated HBV DNA. The ELIMINATE-B trial is investigating PBGENE-HBV at multiple ascending dose levels with three dose administrations per dose level in patients with chronic Hepatitis B. On August 6, 2025, Precision announced Phase 1 safety and efficacy data for Cohort 1, the lowest dose level in the ELIMINATE-B trial. Cohort 1 consisted of three patients each of whom received three planned administrations of 0.2 mg/kg of PBGENE-HBV dosed approximately eight weeks apart. The primary objective is to characterize the safety of PBGENE-HBV. PBGENE-HBV was well-tolerated in all three patients in Cohort 1. Across Cohort 1, no patient experienced above a Grade 2 treatment-related adverse event, a serious adverse event, or dose-limiting toxicity. No clinically significant lab abnormalities were observed, including liver enzymes and platelets. PBGENE-HBV demonstrated a substantial HBsAg reduction in all three patients in Cohort 1 with best response reductions of 56%, 69% and 47% compared to baseline HBsAg levels (ranging between 562-11,813 IU/mL) in patients one, two and three, respectively. One of three patients (33%) in Cohort 1 achieved a durable HBsAg reduction of approximately 50% from baseline that was maintained as of the data cutoff-date (July 28, 2025), which was seven months after initial dosing. This data provides evidence of the ability of PBGENE-HBV to drive a durable antiviral response by editing the viral DNA at the source of chronic Hepatitis B infection. There was no association between baseline HBsAg and efficacy in Cohort 1. Precision also announced initial safety data from Cohort 2 (0.4 mg/kg) in the ELIMINATE-B study. As of the data cutoff, one patient received three dose administrations with two weeks of follow-up, and two patients received one dose administration with four weeks of follow-up. In these patients, no adverse events above Grade 2 were observed. No serious adverse events or dose limiting toxicities were observed, and no cumulative adverse effects were observed. There were no clinically significant elevations of liver transaminases. One additional patient did not complete their dose due to a transient infusion-related serious adverse event that resolved within minutes. The Data Monitoring Committee determined that this transient reaction was not dose-related or dose-limiting. Given the favorable safety profile of Cohorts 1 and 2, the Data Monitoring Committee recently recommended initiation of Cohort 3. The Company is on track to complete dosing of all three patients across all dose administrations in Cohort 2 and commence dosing Cohort 3. The Company expects to provide a data update later in 2025. PBGENE-DMD (Muscle Targeted Excision Program): PBGENE-DMD is Precision's development program for the treatment of DMD. DMD is a genetic disease caused by mutations in the dystrophin gene that prevent production of the dystrophin protein and affects approximately 15,000 patients in the U.S. alone. There are currently no approved therapies that can drive durable and significant functional improvements over time. PBGENE-DMD is designed to improve function for more than 60% of patients afflicted with DMD by employing two complementary ARCUS nucleases delivered in a single AAV to excise exons 45-55 of the dystrophin gene. The aim of this approach is to restore a near-full length functional dystrophin protein within the body that more closely resembles normal dystrophin as opposed to synthetic, truncated dystrophin approaches with minimal functional benefit. The FDA granted PBGENE-DMD Rare Pediatric Disease designation in June 2025 for the treatment of DMD, highlighting the significant unmet need for new therapeutic options. This was followed in July 2025 by the FDA granting PBGENE-DMD Orphan Drug Designation, re-enforcing the need for new and better treatments. With the Rare Pediatric Disease designation, Precision may be eligible to receive a Priority Review Voucher upon FDA approval of PBGENE-DMD. In preclinical data presented at the ASGCT annual meeting in May 2025, PBGENE-DMD demonstrated significant and durable functional improvement in a humanized DMD mouse model. Following AAV delivery, PBGENE-DMD restored the body's ability to produce a functional dystrophin protein broadly across multiple muscle types, including cardiac and skeletal muscles. Over the course of nine months, mice treated with PBGENE-DMD showed increased dystrophin protein expression resulting in substantial and sustained functional muscle improvement. In addition, PBGENE-DMD-edited dystrophin mRNA transcript in muscle satellite stem cells, which are progenitor cells for new muscle cells, supports the potential for long-term durability. In July 2025, Precision announced new preclinical data building upon previous data shared at the ASGCT annual meeting. These data demonstrated that PBGENE-DMD produced a three-fold increase in dystrophin-positive muscle cells between three and nine months in the quadricep, gastrocnemius (calf), heart, and diaphragm. In the gastrocnemius specifically, up to 85% of cells were dystrophin-positive, indicating a high degree of productive gene editing. This broad increase in dystrophin-positive cells combined with the increased dystrophin protein detected in tissues further validates the improved muscle function that was observed over time and may be attributable to edited satellite cells. Precision is advancing the final U.S. investigational new drug (IND)-enabling toxicology studies with an anticipated IND and/or clinical trial application (CTA) filing targeted by the end of 2025 with initial clinical data expected in 2026. PBGENE-3243 (Mutant Mitochondrial DNA Elimination Program): PBGENE-3243 is a first-of-its-kind potential treatment for m.3243-associated mitochondrial disease that is designed to specifically target and eliminate mutant m.3243G mitochondrial DNA, thereby eliminating the root cause of the disease. Precision has paused development of PBGENE-3243 to prioritize its two lead programs, PBGENE-HBV and PBGENE-DMD. Partnered In Vivo Gene Editing Programs iECURE-OTC (Gene Insertion Program): Led by iECURE, ECUR-506 is an ARCUS-mediated in vivo gene editing program currently in a first-in-human Phase 1/2 trial (OTC-HOPE) evaluating ECUR-506 as a potential treatment for neonatal onset ornithine transcarbamylase (OTC) deficiency. Preliminary data from the study presented at ASGCT in May demonstrated a complete clinical response from three months post-exposure to the end of study at six months, as defined by the study protocol. The patient is now more than one year of age and is eating appropriate levels of protein for a child of his age. iECURE has reported that a second infant with severe OTC deficiency was dosed in the first half of 2025. The OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain, and iECURE expects to complete enrollment in 2025 and anticipates complete data from the trial in the first half of 2026. PBGENE-NVS (Gene Insertion Program): Precision continues to advance its gene editing program with Novartis to develop a custom ARCUS nuclease for patients with hemoglobinopathies, such as sickle cell disease and beta thalassemia. The collaborative intent is to insert, in vivo, a therapeutic transgene as a potential one-time transformative treatment administered directly to the patient to overcome disparities in patient access to treatment with other therapeutic technologies, including those that are targeting an ex vivo gene editing approach. Non-Core Ex Vivo Programs Azer-Cel (azercabtagene zapreleucel allogeneic CAR T treatment for cancer): Imugene Limited, Precision's clinical stage partner developing azer-cel for oncology indications, announced updated clinical data in July 2025. In the updated data in patients diagnosed with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), two additional patients achieved a Complete Response and three additional patients achieved a Partial Response. Imugene reported that, as a result of the new data, the best overall response rate for azer-cel in DLBCL reached 75% and the Complete Response rate reached 55%. Based on the updated response rate and maturing durability data, as well as having been awarded FDA Fast Track Designation for DLBCL, Imugene expects to request an end of Phase 1 meeting with the FDA in the fourth quarter of 2025 to present the data and discuss designs for a pivotal/registrational trial for azer-cel. Other Announcements Mark Sulkowski, M.D., Professor of Medicine at the Johns Hopkins University School of Medicine and renowned expert in hepatic and infectious diseases has expanded his advisory role with Precision BioSciences. In the newly created role, Head Clinical Development Advisor, Dr. Sulkowski will work closely with Precision's leadership and cross-functional teams to support clinical strategy across the development lifecycle for the Company's on-going PBGENE-HBV Phase 1 clinical trial as well as initiation of later stage trials. His advisory role will focus on optimizing clinical trials, including translational integration, and aligning scientific rationale with regulatory objectives. Quarter Ended June 30, 2025 Financial Results 'As Precision advances the ELIMINATE-B clinical trial and prepares to file an IND and/or CTA for the PBGENE-DMD program we have been closely managing our operating costs. Cost management is evident in our decision to pause development on PBGENE-3243 in the second quarter and is reflected in a $3.9 million reduction in our second quarter total operating expenses as compared to the same period last year,' said Alex Kelly, Chief Financial Officer of Precision BioSciences. 'We have also extended our expected cash runway to the second half of 2027 to enable meaningful clinical data readouts for PBGENE-HBV and PBGENE-DMD. In July 2025, we initiated an operating efficiency program, including reductions in early research, manufacturing and general & administrative operating expenses which are aimed at reducing our annual cash operating expenses in each of 2026 and 2027 by approximately $25 million compared to the 2025 annual cash expense level.' 'In addition to significantly reducing our operating expenses, Precision will continue to pursue less dilutive sources of cash to even further extend the cash runway, including business development collaborations for future or deprioritized ARCUS programs as well as opportunities to monetize non-core program royalties and milestones,' added Mr. Kelly. Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2025, Precision had approximately $84.8 million in cash, cash equivalents, and restricted cash. Based on its expected cash runway, Precision believes it is sufficiently capitalized to reach important milestones for both programs, including commencement of a Phase 2 study for PBGENE-HBV and a potential pivotal trial for PBGENE-DMD. The Company expects existing cash and cash equivalents, upfront and potential near-term cash from CAR T transactions, along with expected operating efficiencies, operational receipts, and availability of Precision's at-the-market (ATM) facility to extend Precision's cash runway into the second half of 2027. Revenues: Total revenues for the quarter ended June 30, 2025, were less than $0.1 million, as compared to $49.9 million for the quarter ended June 30, 2024. The decrease was expected and primarily the result of $48.2 million of non-cash revenue recognized in the prior period which represented all remaining deferred revenue related to the Prevail Therapeutics Agreement at its conclusion in April 2024 under generally accepted accounting principles. The upfront cash from this collaboration was received and recorded on the balance sheet in January 2021. Research and Development Expenses: Research and development expenses were $12.8 million for the quarter ended June 30, 2025, as compared to $17.2 million for the quarter ended June 30, 2024. The decrease of $4.4 million was primarily due to decreases in PBGENE-HBV direct expenses due to lower manufacturing and toxicology expenses as the program transitioned to the clinic in the fall of 2024. PBGENE-3243, which has been paused, and other research related expenses also decreased in the comparative period, offset by an increase in PBGENE-DMD expenses as the program was accelerated in the second quarter of 2025. General and Administrative Expenses: General and administrative expenses were $9.1 million for the quarter ended June 30, 2025, as compared to $8.5 million for the quarter ended June 30, 2024 as an increase in employee-related costs, including non-cash employee-related costs, offset a decrease in other general and administrative expenses. Net Loss: Net loss was $23.5 million, or ($2.13) per share (basic and diluted), for the quarter ended June 30, 2025. Net income was $32.7 million, or $4.70 per share (basic) and $4.67 per share (diluted), for the quarter ended June 30, 2024. About Precision BioSciences, Inc. Precision BioSciences, Inc. is a clinical stage gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company's pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit The ARCUS® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion (inserting DNA into gene to cause expression/add function), elimination (removing a genome e.g. viral DNA or mutant mitochondrial DNA), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV such as in the DMD program). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the key advantages of ARCUS and its key capabilities and differentiating characteristics; expectations about operational initiatives, strategies, further development, or timing of additional updates or data releases of PBGENE-HBV and PBGENE-DMD, including timing of dose administrations and subsequent cohorts in the ELIMINATE-B trial; the unique design of PBGENE-HBV to eliminate cccDNA and inactivate integrated HBV DNA with high specificity, potentially leading to functional or complete cures; the suitability of PBGENE-HBV for the treatment of hepatitis and the targeting of the root cause of the disease; plans to escalate to higher dose levels and next cohorts in the ELIMINATE-B clinical trial; the potential of PBGENE-DMD to be a first-in-class in vivo gene editing approach addressing the majority of DMD patients; expectations on accelerated development of the PBGENE-DMD program; the design of PBGENE-DMD to improve function over time and address more than 60% of patients with DMD; the potential for PBGENE-DMD to provide durable functional improvement with a one-time lower dose of AAV; the expected timing and opportunities of regulatory processes (including IND-enabling studies and filings such as INDs or CTAs for PBGENE-HBV and PBGENE-DMD and the acceptance of these filings by regulatory agencies); the possibility and eligibility to receive a Priority Review Voucher upon FDA approval of PBGENE-DMD; the safety data and antiviral activity established after the administrations of PBGENE-HBV; translation of results in preclinical studies of ARCUS nucleases to clinical studies in humans; the preclinical and clinical development and demonstrated, potential and expected safety, efficacy, durability, and benefit of PBGENE-HBV and PBGENE-DMD, as well as our other product candidates and those being developed by partners; the complete enrollment of the OTC-HOPE study and timing of full data from the trial in the first half of 2026; expectations and announcements about achievement of key milestones; our expected cash runway and the sufficiency of our cash runway extending into the second half of 2027 to advance PBGENE-HBV and PBGENE-DMD through meaningful Phase 1 data readouts and to enable commencement of a Phase 2 study for PBGENE-HBV and a potential pivotal trial for PBGENE-DMD; the potential of PBGENE-3243 as a first-of-its-kind treatment for m.3243-associated mitochondrial disease; the intention to pursue less dilutive sources of cash to even further extend the cash runway; and expectations from partners, including iECURE and Imugene Limited, on clinical data and timing and opportunities of regulatory processes. In some cases, you can identify forward-looking statements by terms such as 'aim,' 'anticipate,' 'approach,' 'believe,' 'contemplate,' 'could,' 'design,' 'designed,' 'estimate,' 'expect,' 'goal,' 'intend,' 'look,' 'may,' 'mission,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'pursue,' 'should,' 'strive,' 'suggest,' 'target,' 'will,' 'would,' or the negative thereof and similar words and expressions. Forward-looking statements are based on management's current expectations, beliefs, and assumptions and on information currently available to us. These statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding to advance our programs; risks associated with our capital requirements, anticipated cash runway, requirements under our current debt instruments and effects of restrictions thereunder, including our ability to raise additional capital due to market conditions and/or our market capitalization; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators' or other licensees' ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators or other licensees related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators' or other licensees' development of product candidates; our or our collaborators' or other licensees' ability to advance product candidates into, and successfully design, implement and complete, clinical trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; delays or difficulties in our and our collaborators' and other licensees' ability to enroll patients; changes in interim 'top-line' and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; our or our licensees' ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators' or other licensees' ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration and other license agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price; our ability to meet the requirements of and maintain listing of our common stock on Nasdaq or other public stock exchanges; and other important factors discussed under the caption 'Risk Factors' in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC's website at and the Investors page of our website under SEC Filings at All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Precision Biosciences, Inc. Balance Sheets Data (In thousands, except share amounts) June 30, 2025 December 31, 2024 Cash, cash equivalents, and restricted cash $ 84,806 $ 108,468 Working capital 56,691 80,009 Total assets 108,928 136,388 Total liabilities 74,874 79,995 Total stockholders' equity $ 34,054 $ 56,393 Common stock outstanding 11,636,981 8,202,715 Expand
Business Wire
2 hours ago
- Business Wire
NeueHealth Reports Second Quarter 2025 Results
DORAL, Fla.--(BUSINESS WIRE)--NeueHealth, Inc. ('NeueHealth' or the 'Company') (NYSE: NEUE), the value-driven healthcare company, today reported financial results for its second quarter ended June 30, 2025. 'We are pleased to report another strong quarter of financial results as we continue to build on the momentum we have established across our business this year,' said Mike Mikan, President and CEO of NeueHealth. 'We delivered our sixth consecutive quarter of Adjusted EBITDA profitability, and we are continuing to see strong performance across product categories, including the ACA Marketplace, Medicare, and Medicaid. In the second quarter and beyond, we are focused on advancing our end-to-end, value-based care enablement platform that will power the future of our company, supporting clinical, financial, and administrative functions to create a more aligned and coordinated care experience for all.' Key Metrics Three Months Ended Six Months Ended ($ in thousands) June 30, June 30, 2025 2024 2025 2024 Financial Metrics Revenue $ 209,082 $ 225,991 $ 424,869 $ 471,086 Net Loss $ (1,548 ) $ (57,698 ) $ (12,396 ) $ (61,875 ) Net Income (Loss) from Continuing Operations $ 6,838 $ (39,259 ) $ 5,400 $ (33,571 ) Adjusted EBITDA (non-GAAP) $ 19,020 $ 3,962 $ 32,499 $ 7,618 Expand See the table at the end of this release for additional information and a reconciliation of the non-GAAP measures used in the table above. See table at the end of this release for more detail. Earnings Conference Call As previously announced, NeueHealth will discuss the Company's results, strategy, and outlook on a conference call with investors at 8:00 a.m. Eastern Time today. NeueHealth will host a live webcast of this conference call which can be accessed from the Investor Relations page of the Company's website ( Following the call, a webcast replay will be available on the same site. This earnings release and the Form 8-K filed August 7, 2025 can be accessed on the Investor Relations page of the Company's website. We routinely post important information on our website, including corporate and investor presentations and financial information. 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. Such disclosures will be included in the Investor Relations section of our website. Accordingly, investors should monitor this portion of our website, in addition to following our press releases, U.S. Securities and Exchange Commission ('SEC') filings and public conference calls and webcasts. About NeueHealth NeueHealth is a value-driven healthcare company grounded in the belief that all health consumers are entitled to high-quality, coordinated care. By uniquely aligning the interests of health consumers, providers, and payors, NeueHealth helps to make healthcare accessible and affordable to all populations across the ACA Marketplace, Medicare, and Medicaid. NeueHealth delivers high-quality clinical care to over 600,000 health consumers through owned clinics and unique partnerships with over 3,000 affiliated providers. We also enable independent providers and medical groups to thrive in performance-based arrangements through a suite of technology and services scaled centrally and deployed locally. We believe our value-driven, consumer-centric care model can transform the healthcare experience and maximize value across the healthcare system. For more information, visit: Forward-Looking Statements This release contains certain 'forward-looking statements' within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements made in this release that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements and should be evaluated as such. Forward-looking statements include information concerning possible or assumed future results of operations, including descriptions of our business plan and strategies, as well as statements regarding timing, completion, and effects of the transaction contemplated by the Agreement and Plan of Merger (the 'Merger Agreement') entered into by the Company with NH Holdings 2025, Inc. ('Parent') on December 23, 2024 pursuant to which, if all applicable conditions are satisfied or waived, the Company will become a wholly owned subsidiary of Parent (the 'Transaction'). Parent is indirectly controlled by private investment funds affiliated with New Enterprise Associates, Inc. ('NEA'). These statements often include words such as 'anticipate,' 'expect,' 'plan,' 'believe,' 'intend,' 'project,' 'forecast,' 'estimates,' 'projections,' 'outlook,' 'ensure,' and other similar expressions. These forward-looking statements include any statements regarding our plans and expectations. Such forward-looking statements are subject to various risks, uncertainties and assumptions. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. Factors that might materially affect such forward-looking statements include: the failure to complete the Transaction on the anticipated terms and within the anticipated timeframe, including as a result of failure to obtain required stockholder or regulatory approvals or to satisfy other closing conditions; potential litigation relating to the Transaction that could be instituted against NEA, the Company or their respective affiliates, directors, managers, officers or employees, and the effects of any outcomes related thereto; potential adverse reactions or changes to our business relationships or operating results resulting from the announcement, pendency or completion of the Transaction; the risk that our stock price may decline significantly if the Transaction is not consummated; certain restrictions during the pendency of the Transaction that may impact our ability to pursue certain business opportunities or strategic transactions; costs associated with the Transaction, which may be significant; the occurrence of events, changes or other circumstances that could give rise to the termination of the Merger Agreement, including in circumstances requiring us to pay a termination fee; our ability to continue as a going concern; expectations and outcomes related to the Merger Agreement; our ability to comply with the terms of our credit facilities or any credit facility into which we enter in the future; our ability to obtain any short or long term debt or equity financing needed to operate our business; our ability to quickly and efficiently complete the wind down of our remaining Individual and Family Plan ('IFP') businesses and MA businesses outside of California, including by satisfying liabilities of those businesses when due and payable; potential disruptions to our business due to the Transaction or corporate restructuring and any resulting headcount reduction; our ability to accurately estimate and effectively manage the costs relating to changes in our business offerings and models; a delay or inability to withdraw regulated capital from our subsidiaries; a lack of acceptance or slow adoption of our business model; our ability to retain existing consumers and expand consumer enrollment; our and our care partner's abilities to obtain and accurately assess, code, and report risk adjustment factor scores; our ability to contract with care providers and arrange for the provision of quality care; our ability to accurately estimate medical expenses; our ability to obtain claims information timely and accurately; the impact of any pandemic or epidemic on our business and results of operations; the risks associated with our reliance on third-party providers to operate our business; the impact of modifications or changes to the U.S. health insurance markets; the impact of changes to federal funding for government healthcare programs; our ability to manage any growth of our business; our ability to operate, update or implement our technology platforms and other information technology systems; our ability to retain key executives; our ability to successfully pursue acquisitions and integrate acquired businesses and divest businesses as needed; the occurrence of severe weather events, catastrophic health events, natural or man-made disasters, and social and political conditions or civil unrest; our ability to prevent and contain data security incidents and the impact of data security incidents on our members, patients, employees and financial results; our ability to comply with requirements to maintain effective internal controls; the outcome of threatened or pending litigation and risks of future legal disputes; the impacts resulting from new (or change to existing) laws, regulations and executive actions; our ability to mitigate risks associated with our ACO REACH and related businesses, including any unanticipated market or regulatory developments; and the other factors set forth under the heading 'Risk Factors' in the Company's reports on Form 10-K, Form 10-Q, and Form 8-K (including all amendments to those reports) and our other filings with the SEC. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this release to conform these statements to actual results or changes in our expectations. June 30, 2025 2024 Assets Current assets: Cash and cash equivalents $ 131,618 $ 83,295 Short-term investments 13,946 9,871 Accounts receivable, net of allowance of $55 and $27, respectively 53,074 36,594 ACO REACH performance year receivable 321,596 95,075 Current assets of discontinued operations 89,804 173,006 Prepaids and other current assets 29,844 36,807 Total current assets 639,882 434,648 Other assets: Long-term investments — — Property, equipment and capitalized software, net 11,664 11,240 Intangible assets, net 66,088 71,064 Other non-current assets 26,055 27,431 Total other assets 103,807 109,735 Total assets $ 743,689 $ 544,383 Liabilities, Redeemable Noncontrolling Interest, Redeemable Preferred Stock and Shareholders' Equity (Deficit) Current liabilities: Medical costs payable $ 97,837 $ 124,360 Accounts payable 5,317 6,298 Short-term borrowings 1,000 2,000 ACO REACH performance year obligation 248,465 — Current liabilities of discontinued operations 333,799 344,651 Risk share payable to deconsolidated entity 123,981 123,981 Warrant liability 27,651 29,738 Other current liabilities 70,362 79,200 Total current liabilities 908,412 710,228 Long-term borrowings 212,433 202,614 Other liabilities 15,899 17,649 Total liabilities 1,136,744 930,491 Commitments and contingencies Redeemable noncontrolling interests 55,729 48,580 Redeemable Series A preferred stock, 0.0001 par value; 750,000 shares authorized in 2025 and 2024; 750,000 shares issued and outstanding in 2025 and 2024 747,481 747,481 Redeemable Series B preferred stock, 0.0001 par value; 175,000 shares authorized in 2025 and 2024; 175,000 shares issued and outstanding in 2025 and 2024 172,936 172,936 Shareholders' equity (deficit): Common stock, 0.0001 par value; 3,000,000,000 shares authorized in 2025 and 2024; 9,024,240 and 8,320,959 shares issued and outstanding in 2025 and 2024, respectively 1 1 Additional paid-in capital 3,107,121 3,099,423 Accumulated deficit (4,464,323 ) (4,442,529 ) Accumulated other comprehensive loss — — Treasury stock, at cost, 31,526 shares at December 31, 2025 and 2024 (12,000 ) (12,000 ) Total shareholders' equity (deficit) (1,369,201 ) (1,355,105 ) Total liabilities, redeemable noncontrolling interests, redeemable preferred stock and shareholders' equity (deficit) $ 743,689 $ 544,383 Expand NeueHealth, Inc. and Subsidiaries Consolidated Statements of Income (Loss) (in thousands, except share and per share data) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, Revenue: Capitated revenue $ 82,532 $ 64,005 $ 163,519 $ 125,471 ACO REACH revenue 115,339 149,802 239,379 321,613 Service revenue 10,420 12,076 20,254 23,691 Investment income 791 108 1,717 311 Total revenue 209,082 225,991 424,869 471,086 Operating expenses: Medical costs 146,410 177,681 307,304 374,555 Operating costs 44,860 70,470 93,533 137,231 Intangible assets impairment — 11,411 — 11,411 Depreciation and amortization 3,555 3,978 7,114 8,540 Total operating expenses 194,825 263,540 407,951 531,737 Operating income (loss) 14,257 (37,549 ) 16,918 (60,651 ) Interest expense 6,878 4,110 13,515 7,040 Warrant expense (income) 562 (2,213 ) (2,087 ) (4,285 ) Gain on troubled debt restructuring — — — (30,311 ) Income (Loss) from continuing operations before income taxes 6,817 (39,446 ) 5,490 (33,095 ) Income tax (benefit) expense (21 ) (187 ) 90 476 Net income (loss) from continuing operations 6,838 (39,259 ) 5,400 (33,571 ) Loss from discontinued operations, net of tax (8,386 ) (18,439 ) (17,796 ) (28,304 ) Net Loss (1,548 ) (57,698 ) (12,396 ) (61,875 ) Net income from continuing operations attributable to noncontrolling interests (8,507 ) (932 ) (9,398 ) (12,669 ) Series A preferred stock dividend accrued (10,981 ) (10,422 ) (21,710 ) (20,716 ) Series B preferred stock dividend accrued (2,465 ) (2,338 ) (4,872 ) (4,648 ) Net loss attributable to NeueHealth, Inc. common shareholders $ (23,501 ) $ (71,390 ) $ (48,376 ) $ (99,908 ) Basic and loss income per share attributable to NeueHealth, Inc. common shareholders Continuing operations $ (1.68 ) $ (6.42 ) $ (3.49 ) $ (8.77 ) Discontinued operations (0.94 ) (2.23 ) (2.04 ) (3.46 ) Basic and diluted loss per share (2.62 ) (8.65 ) (5.53 ) (12.23 ) Basic and diluted weighted-average common shares outstanding 8,978 8,253 8,750 8,166 Expand NeueHealth, Inc. and Subsidiaries Consolidated Statements of Cash Flows (in thousands) (Unaudited) Six Months Ended June 30, 2025 2024 Cash flows from operating activities: Net loss $ (12,396 ) $ (61,875 ) Adjustments to reconcile net loss to net cash provided by operating activities: Depreciation and amortization 7,114 8,540 Impairment of intangible assets — 11,411 Share-based compensation 7,497 37,407 Payment-In-Kind ('PIK') Interest 8,952 — Gain on troubled debt restructuring — (30,311 ) Net accretion of investments (202 ) (72 ) Loss on disposal of property, equipment, and capitalized software 87 595 Other, net 1,029 (469 ) Changes in assets and liabilities, net of acquired assets and liabilities: Accounts receivable (16,480 ) (4,872 ) ACO REACH performance year receivable (226,521 ) (309,639 ) Other assets 9,567 (7,889 ) Medical cost payable (31,421 ) (35,998 ) Risk adjustment payable (4,996 ) (4,155 ) Accounts payable and other liabilities (12,483 ) (14,387 ) Unearned revenue — (11 ) Warrant liability (2,087 ) 8,978 ACO REACH performance year obligation 248,465 325,599 Net cash used in operating activities (23,875 ) (77,148 ) Cash flows from investing activities: Purchases of investments (8,224 ) (9,544 ) Proceeds from sales, paydown, and maturities of investments 4,388 2,581 Purchases of property and equipment (2,653 ) (877 ) Proceeds from sale of business, net 61,139 197,121 Net cash provided by investing activities 54,650 189,281 Cash flows from financing activities: Proceeds from long-term borrowings — 52,411 Repayments of short-term borrowings (1,000 ) (273,636 ) Distributions to noncontrolling interest holders (2,249 ) (4,730 ) Net cash used in financing activities (3,249 ) (225,955 ) Net increase (decrease) in cash and cash equivalents 27,526 (113,822 ) Cash and cash equivalents – beginning of year $ 185,405 $ 375,280 Cash and cash equivalents – end of period $ 212,931 $ 261,458 Expand NeueHealth, Inc. and Subsidiaries Segment Information (in thousands) (Unaudited) NeueCare ($ in thousands) Three Months Ended June 30, Six Months Ended June 30, Statement of income (loss) and operating data: 2025 2024 2025 2024 Revenue: Capitated revenue $ 81,407 $ 64,005 $ 162,394 $ 125,471 Service revenue 6,874 9,803 13,138 19,333 Investment income 120 21 477 21 Total unaffiliated revenue 88,401 73,829 176,009 144,825 Affiliated revenue 3,227 3,156 6,136 5,783 Total segment revenue 91,628 76,985 182,145 150,608 Operating expenses Medical Costs 36,723 33,579 74,241 61,015 Operating Costs 28,936 34,676 56,146 67,265 Intangible assets impairment — 11,411 — 11,411 Depreciation and amortization 2,757 3,221 5,539 7,007 Total operating expenses 68,416 82,887 135,926 146,698 Operating income (loss) $ 23,212 $ (5,902 ) $ 46,219 $ 3,910 Expand Non-GAAP Financial Measures We use the non-GAAP financial measures Adjusted EBITDA and Adjusted Operating Cost Ratio. We define Adjusted EBITDA as Net Loss excluding loss from discontinued operations, interest expense, income taxes, depreciation and amortization, transaction costs, share-based and other long-term compensation expense, impact of troubled debt restructuring, restructuring and contract termination costs, impairment of goodwill and long-lived assets, losses related to the bankruptcy of one of our ACO REACH partners, impact of classifying certain of our operations as held-for-sale, and changes in the fair value of derivatives. We define Adjusted Operating Cost Ratio as Operating Cost Ratio excluding share-based compensation expense. These non-GAAP measures have been presented in this quarterly Earnings Release or in the earnings conference call and related materials as supplemental measures of financial performance that are not required by or presented in accordance with GAAP because we believe they assist management and investors in comparing our operating performance across reporting periods on a consistent basis by excluding and including items that we do not believe are indicative of our core operating performance. Management believes these measures are useful to investors in highlighting trends in our operating performance, while other measures can differ significantly depending on long-term strategic decisions regarding capital structure, the tax jurisdictions in which we operate and capital investments. Management uses Adjusted EBITDA and Adjusted Operating Cost Ratio to supplement GAAP measures of performance in the evaluation of the effectiveness of our business strategies, to make budgeting decisions, to establish discretionary annual incentive compensation and to compare our performance against that of other peer companies using similar measures. Management supplements GAAP results with non-GAAP financial measures to provide a more complete understanding of the factors and trends affecting the business than GAAP results alone. Adjusted EBITDA is not a recognized term under GAAP and should not be considered as an alternative to Net Income (Loss) as a measure of financial performance or any other performance measure derived in accordance with GAAP. Additionally, Adjusted EBITDA is not intended to be a measure of free cash flow available for management's discretionary use as it does not consider certain cash requirements such as interest payments, tax payments and debt service requirements. The presentation of Adjusted EBITDA has limitations as an analytical tool and should not be considered in isolation or as a substitute for analysis of our results as reported under GAAP. Because not all companies use identical calculations, the presentation of these measures may not be comparable to other similarly titled measures of other companies and can differ significantly from company to company. Adjusted Operating Cost Ratio is not a recognized term under GAAP and should not be considered as an alternative to Operating Cost Ratio as a measure of financial performance or any other performance measure derived in accordance with GAAP. The presentation of Adjusted Operating Cost Ratio has limitations as an analytical tool and should not be considered in isolation or as a substitute for analysis of our results as reported under GAAP. Because not all companies use identical calculations, the presentation of these measures may not be comparable to other similarly titled measures of other companies and can differ significantly from company to company. The following table provides a reconciliation of net loss to Adjusted EBITDA for the periods presented: (a) Transaction costs include accounting, tax, valuation, consulting, legal and investment banking fees directly relating to financing initiatives and acquisitions or dispositions. These costs can vary from period to period and impact comparability, and we do not believe such transaction costs reflect the ongoing performance of our business. (b) Represents non-cash compensation expense related to stock option and restricted stock unit award grants, which can vary from period to period based on several factors, including the timing, quantity and grant date fair value of the awards. Also includes $0.1 million and $0.2 million of compensation expense that was recognized for the cancellation of P-Unit Awards in relation to our purchase of the minority interest in Centrum for the three and six months ended June 30, 2025. There was no equivalent compensation expense included for the three and six months ended June 30, 2024. (c) Represents the non-cash change in the fair value of the warrant liability established for warrants included in our financing arrangements, which are remeasured at fair value each reporting period. (d) Restructuring and contract termination costs represent severance costs as part of a workforce reduction, amounts paid for early termination of leases, and impairment of certain long-lived assets primarily relating to our decision to exit the Commercial business for the 2023 plan year. (e) Beginning in the second quarter of 2024, Adjusted EBITDA excludes the impact of our operations classified as held-for-sale that were subsequently sold in November 2024. (f) Represents the costs incurred as a result of one of our ACO REACH care partners filing for bankruptcy; includes the full allowance established for the outstanding receivable and ongoing costs incurred to manage and provide service to members attributed to the care partner that would have otherwise been reimbursed prior to the care partner's bankruptcy. (g) Adjustment has been updated to remove the impact of our held-for-sale operations that are adjusted for in their entirety as described in (e). Expand The following table provides a reconciliation of Adjusted Operating Cost Ratio for the periods presented: (a) Represents non-cash compensation expense related to stock option and restricted stock unit award grants, which can vary from period to period based on several factors, including the timing, quantity and grant date fair value of the awards. Also includes $0.1 million and $0.2 million of compensation expense that was recognized for the cancellation of P-Unit Awards in relation to our purchase of the minority interest in Centrum for the three and six months ended June 30, 2025. There was no equivalent compensation expense included within for the three and six months ended June 30, 2024. (b) Represents the impact of revenue and operating costs related to our operations classified as held-for-sale beginning in the second quarter of 2024. The sale was completed in November 2024. (c) Transaction related costs include accounting, tax, valuation, consulting, legal and investment banking fees directly relating to financing initiatives and acquisitions or dispositions. These costs can vary from period to period and impact comparability, and we do not believe such transaction costs reflect the ongoing performance of our business. Expand
