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"description": "CRISPR Therapeutics (CRSP) stock falls as company's Q2 results miss consensus amid focus on its Cagevy gene therapy developed with Vertex Pharma (VRTX). Read more here.",
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"snippet": "Shares of CRISPR Therapeutics (NASDAQ:CRSP) continued to drop in the premarket on Tuesday after the Swiss biotech posted lower-than-expected Q2 2025 financials,...",
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"title": "Sensei Biotherapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update",
"description": "- Full data for Phase 1/2 dose expansion cohort expected by year-end 2025 -- Cash runway into the second quarter of 2026 - BOSTON, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the second quarter 2025, and provided a corporate update. 'The second quarter was a key inflection point for Sensei, as we now transition from early response-focused readouts to longer-term and commercially relevant efficacy signals with the maturity of the data from our Phase 1/2 study of solnerstotug,” said John Celebi, President and CEO of Sensei. 'Solnerstotug has demonstrated a favorable safety profile and in combination with cemiplimab has not demonstrated significant additional toxicity relative to what is typically observed with PD-(L)1 monotherapy, which we believe could translate into better patient adherence and more meaningful long-term outcomes with continued treatment, as well as physician preference and payor interest.” 'As we look to next steps in the clinical advancement of solnerstotug, we envision multiple Phase 2 studies across PD-(L)1 resistant tumor types, aligned with unmet need and commercial potential. We view these differentiated opportunities as potentially derisking overall, while positioning solnerstotug for multiple indications in high-value immunotherapy segments of the ~$50 billion PD-(L)1 market,” added Mr. Celebi. 'We continue to work on finalizing the Phase 2 strategy for solnerstotug, which will be strongly influenced by the full dose expansion dataset we plan to present later this year.” Solnerstotug (formerly SNS-101) is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates. Sensei’s ongoing multi-center Phase 1/2 clinical trial is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of solnerstotug as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) in patients with advanced solid tumors. Clinical Program Highlights:Full dose expansion data, including 6-month progression free survival (PFS), from the Phase 1/2 study continues to be expected by year-end 2025.Enrollment in the Phase 1/2 dose expansion cohort is complete with a total of 64 patients, including: 10 'cold” MSS CRC patients in the monotherapy arm54 patients in the cemiplimab combination arm consisting of 10 'cold” MSS CRC patients and 44 'hot” tumor patients. 41/44 patients in the 'hot” tumor cohort had received and progressed on a prior PD-(L)1 inhibitor.On March 27th, Sensei announced favorable preliminary clinical data in PD-(L)1 resistant patients from the dose expansion stage of its ongoing Phase 1/2 trial, demonstrating favorable activity in patients with PD-(L)1 resistant 'hot” tumors. Solnerstotug continued to be well tolerated, with no dose-limiting toxicities, and the majority of AEs Grade 1 or 2 in severity.A replay of the March 2025 webcast related to the preliminary data, featuring study investigator Dr. Shiraj Sen, is available on the Sensei website.Corporate Updates:On July 30th, the Company announced that clinical data from the dose expansion cohort of the Phase 1/2 trial of solnerstotug alone and in combination with cemiplimab will be presented in a mini oral session at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21, 2025 in Berlin, Germany.Sensei regains Nasdaq compliance following the 1-for-20 reverse split of its common stock, which became effective at 5:00 p.m. ET on June 16th, and subsequent 10-day bid price remaining above $1.On April 7th, John Celebi participated in a panel discussion titled 'New Radiotherapy and Targeted Therapy Approaches” at the Canaccord Genuity Horizons in Oncology Virtual Conference. The panel focused on emerging innovations in cancer treatment and Sensei’s approach to selectively modulating the tumor microenvironment. Second Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $28.6 million as of June 30, 2025, as compared to $41.3 million as of December 31, 2024. Sensei expects its current cash balance to fund operations into the second quarter of 2026. Research and Development (R&D) Expenses: R&D expenses were $2.5 million for the quarter ended June 30, 2025, compared to $4.6 million for the quarter ended June 30, 2024. The decrease in R&D expenses was primarily attributable to lower personnel and facilities costs, and reduced manufacturing cost. General and Administrative (G&A) Expenses: G&A expenses were $2.7 million for the quarter ended June 30, 2025, compared to $3.2 million for the quarter ended June 30, 2024. The decrease in G&A expense was primarily attributable to lower personnel costs. Net Loss: Net loss was $4.9 million for the quarter ended June 30, 2025, compared to $7.1 million for the quarter ended June 30, 2024. About Sensei Biotherapeutics Sensei Biotherapeutics (Nasdaq: SNSE) is a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients. Through its TMAb™ (Tumor Microenvironment Activated biologics) platform, Sensei develops conditionally active therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment to unleash T cells against tumors. Sensei’s lead product candidate is solnerstotug, a conditionally active antibody designed to block the V-domain Ig suppressor of T cell activation (VISTA) checkpoint selectively within the low pH tumor microenvironment, where VISTA acts as a suppressor of T cells by binding the receptor PSGL-1. For more information, please visit www.senseibio.com, and follow the company on X @SenseiBio and LinkedIn. Condensed Statements of Operations(Unaudited, in thousands except share and per share data) Three Months Ended June 30, 2025 2024 Operating expenses: Research and development $2,533 $4,584 General and administrative 2,673 3,203 Total operating expenses 5,206 7,787 Loss from operations (5,206) (7,787)Total other income 270 645 Net loss (4,936) (7,142)Net loss attributable to common stockholders (4,936) (7,142)Net loss per share, basic and diluted $(3.91) $(5.69)Weighted-average common shares outstanding, basic and diluted 1,260,867 1,255,145 Selected Condensed Balance Sheet Data (Unaudited, in thousands) June 30, 2025 December 31, 2024 Cash and cash equivalents $12,557 $9,994 Marketable securities 16,071 31,341 Total assets 31,783 45,361 Total liabilities 4,469 6,975 Total stockholders’ equity 27,314 38,386 Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as 'believe”, 'designed to,” 'expect”, 'may”, 'plan”, 'potential”, 'will”, and similar expressions, and are based on Sensei’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of Sensei’s product candidates, the timing of Sensei’s Phase 1/2 clinical trial of solnerstotug, including reporting of data therefrom, the planning and strategy for Phase 2 clinical studies of solnerstotug, and its belief that its existing cash and cash equivalents will be sufficient to fund its operations into the second quarter of 2026. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Sensei’s product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Sensei’s product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies and clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Sensei’s product candidates; the risk that Sensei’s product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Sensei anticipates; risks associated with Sensei’s dependence on third-party suppliers and manufacturers, including sole source suppliers, over which Sensei may not always have full control; risks regarding the accuracy of Sensei’s estimates of expenses, capital requirements and needs for additional financing; and other risks and uncertainties that are described in Sensei’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on August 5, 2025 and Sensei’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor and Media Contact: Joyce Allaire LifeSci Advisors Jallaire@lifesciadvisors.com**media[700293]**",
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"description": "July MAUs reach 1.7 million; Treasury contains 2,087 BTC OMAHA, Neb., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Exodus Movement, Inc. (NYSE American: EXOD) ('Exodus' or 'the company”), a leading self-custodial cryptocurrency platform, today announced an update to selected digital asset holdings of Exodus’ corporate treasury, as well as updated user and exchange provider processed volume metrics, as of July 31, 2025: SelectedDigital Asset Holdings (Unaudited) Bitcoin (BTC): 2,087 BTC as of July 31, 2025 compared to 2,058 as of June 30, 2025 Ethereum (ETH): 2,742 ETH as of July 31, 2025 compared to 2,729 as of June 30, 2025 Solana (SOL): 34,578 SOL as of July 31, 2025 compared to 31,823 as of June 30, 2025 Users Monthly Active Users (MAUs): 1.7 million as of July 31, 2025, of which approximately 20,000 are Passkeys wallets. That figure compares with the 1.5 million MAUs as of June 30, 2025, of which approximately 21,000 were Passkeys wallets. Swap Volume Exodus’ exchange provider processed volume was $632 million for the month of July 2025, of which $149 million (24%) originated from the company’s XO Swap partners. This volume compares with $446 million exchange provider processed volume in June 2025, of which $90 million (20%) originated from XO Swap partners. Exodus CFO James Gernetzke remarked: 'July operations generated an increase in our digital asset treasury once again. We look forward to detailed updates and discussion in our upcoming earnings call on Monday, August 11th.' About Exodus Exodus is a financial technology leader empowering individuals and businesses with secure, user-friendly crypto software solutions. Since 2015, Exodus has made digital assets accessible to everyone through its multi-asset crypto wallets prioritizing design and ease of use. With self-custodial wallets, Exodus puts customers in full control of their funds, enabling them to swap, buy, and sell crypto. Its business solutions include Passkeys Wallet and XO Swap, industry-leading tools for embedded crypto wallets and swap aggregation. Exodus is committed to driving the future of accessible and secure finance. Learn more at exodus.com or follow us on X at x.com/exodus. Investor Contactinvestors@exodus.comMedia Contact Ryan Dicovitsky/Diana Bost, Dukas Linden Public Relations exodus@dlpr.comDisclosure Information Exodus uses the following as means of disclosing material nonpublic information and for complying with disclosure obligations under Regulation FD: websites exodus.com/investors and exodus.com; press releases; public videos, calls, and webcasts; and social media: X (@exodus and JP Richardson's feed @jprichardson), Facebook, LinkedIn, and YouTube. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements are based on our beliefs and assumptions and on information currently available to us as of the date hereof. In some cases, you can identify forward-looking statements by the following words: 'will,” 'expect,” 'would,” 'should,” 'intend,” 'believe,” 'expect,” 'likely,” 'believes,” 'views”, 'estimates”, or other comparable terminology. Forward-looking statements in this document include, but are not limited to, management statements regarding management’s confidence in our products, services, business trajectory and plans, expectations regarding demand for our products, volatility and trading volumes of digital asset markets, and the date and nature of investor communications. Such forward-looking statements involve a number of risks, uncertainties and other important factors that could cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Such factors include those set forth in 'Item 1. Business” and 'Item 1A. Risk Factors” of Form 10-K filed with the Securities and Exchange Commission (the 'SEC”) on March 6, 2025, as well as in our other reports filed with the SEC from time to time. All forward-looking statements are expressly qualified in their entirety by such cautionary statements. Readers are cautioned not to place undue reliance on such forward-looking statements. Except as required by law, we undertake no obligation to update or revise any forward-looking statements that have been made to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. **media[700263]**",
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"title": "Rhythm Pharmaceuticals Reports Second Quarter 2025 Financial Results and Business Update",
"description": "-- Second quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of $48.5 million ---- U.S. and EU regulatory submissions for setmelanotide in acquired hypothalamic obesity on track to be completed in the third quarter of 2025 ---- Bivamelagon Phase 2 trial met primary endpoint with statistically significant, clinically meaningful BMI reductions in patients with acquired hypothalamic obesity -- -- Raised approximately $189.2 million in net proceeds in upsized public offering of common stock -- -- Management to host conference call today at 8:00a.m. ET -- BOSTON, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today reported financial results and provided a business update for the second quarter ended June 30, 2025. 'Rhythm has made significant progress in advancing our melanocortin-4 receptor agonism platform and executing on our global mission to transform the lives of patients with rare neuroendocrine diseases,” said David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm. 'This quarter, we presented strong Phase 2 and Phase 3 data that demonstrated the potential efficacy of both bivamelagon and setmelanotide, respectively, as treatment options for patients with acquired hypothalamic obesity.” Dr. Meeker continued, 'Global commercial sales of IMCIVREE achieved double-digit growth this quarter, and we also strengthened our balance sheet through an upsized common stock offering in July. We enter the second half of 2025 well-positioned to drive sustained growth and value for patients and shareholders by working to expand the reach of setmelanotide into additional rare MC4R pathway diseases and develop new therapeutic options designed to improve the patient experience.” Second Quarter and Recent Business HighlightsRevenue from global sales of IMCIVREE was $48.5 million for the second quarter of 2025, an increase of 29% percent on a sequential basis from the first quarter of 2025, primarily driven by sales of IMCIVREE for the treatment of patients with Bardet-Biedl syndrome (BBS). In the second quarter of 2025, revenue of $32.0 million, or 66% of product revenue, was generated in the United States, an increase of 31% on a sequential basis. Revenue of $16.5 million, or 34% of product revenue, was generated outside the United States, a sequential increase of 24%; andOn July 11, 2025, Rhythm closed an upsized public offering of 2,367,647 shares of its common stock at a price of $85 per share, resulting in net proceeds of approximately $189.2 million, net of underwriting discounts and commissions, but excluding certain other offering expenses payable by the Company.Second Quarter and Recent Clinical Development HighlightsToday, Rhythm announced that it has enrolled the first patient with hypothalamic obesity in Part C of its Phase 1 trial evaluating RM-718, a weekly-administered melanocortin-4 receptor (MC4R) agonist;On July 12, 2025, at the Endocrine Society’s Annual Meeting, data from the Company’s pivotal Phase 3 TRANSCEND trial evaluating setmelanotide in acquired hypothalamic obesity, the largest randomized, placebo-controlled trial in acquired hypothalamic obesity to date, were delivered in an oral presentation. Highlights of the presentation included: -19.8% placebo-adjusted difference in BMI reduction (N=120); andStatistically significant BMI reductions following setmelanotide treatment were consistently observed across subgroups stratified by age (On July 9, 2025, Rhythm announced bivamelagon achieved statistically significant and clinically meaningful reductions in body mass index (BMI) at 14 weeks of treatment in its Phase 2 trial in patients with acquired hypothalamic obesity, including; -9.3% BMI reduction from baseline in the 600mg cohort (n=8) (p-value=0.0004);-7.7% BMI reduction from baseline in the 400mg cohort (n=7) (p-value=0.0002);Post-hoc analyses showing bivamelagon demonstrated BMI reductions consistent with BMI reductions achieved with setmelanotide therapy as observed in similar patient populations at comparable dosing durations; andSafety and tolerability results were consistent with MC4R agonism and mechanism of action during the placebo-controlled portion of the trial; andDuring the Joint Congress between the European Society for Paediatric Endocrinology and the European Society of Endocrinology (ESPE-ESE) and the European Congress on Obesity (ECO) in May 2025, Rhythm presented new, real-world data that showed consistent improvements in body mass index, BMI-Z, and hunger scores in 30 patients with acquired hypothalamic obesity and five (5) patients with congenital hypothalamic obesity who were treated with setmelanotide for up to nine months.Anticipated Upcoming Milestones Rhythm expects to achieve the following near-term milestones: Complete submissions of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) and a Type II variation request to the European Medicines Agency seeking approval for setmelanotide for the treatment of acquired hypothalamic obesity in the third quarter of 2025;Disclose preliminary results from the Company’s setmelanotide Phase 2 trial in Prader-Willi syndrome in the second half of 2025;Complete enrollment in the Phase 1, Part C trial evaluating the weekly, MC4R agonist RM-718 in patients with acquired hypothalamic obesity in the first quarter of 2026;Announce topline data in the 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired hypothalamic obesity in the first quarter of 2026;Announce topline data in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in the first quarter of 2026;Complete enrollment in the setmelanotide Phase 3 trial substudy in congenital hypothalamic obesity in the first half of 2026; andPending alignment with U.S and European regulatory agencies, initiate a pivotal Phase 3 trial evaluating bivamelagon in acquired hypothalamic obesity in 2026. In addition, Rhythm announced today that it plans to host 'Commercial Readiness for Acquired Hypothalamic Obesity”, an in-person and webcasted event for investors and analysts, on September 24, 2025, in Boston to review its global launch strategy for setmelanotide. The event will also feature insights from leading physicians about the urgent need to treat patients with acquired hypothalamic obesity. Registration details will follow. Second Quarter 2025 Financial Results:Cash Position: As of June 30, 2025, cash, cash equivalents and short-term investments were approximately $291.0 million, as compared to $320.6 million as of December 31, 2024. The quarter-end cash position does not include approximately $189.2 million in net proceeds from a public offering of common stock that closed on July 11, 2025; but it does include $40 million subsequently paid by the Company to LG Chem, Ltd. in July 2025 as part of the acquisition of bivamelagon announced in January 2024. Revenue: Net product revenues relating to global sales of IMCIVREE were $48.5 million for the second quarter of 2025, as compared to $29.1 million for the second quarter of 2024. R&D Expenses: R&D expenses were $42.3 million in the second quarter of 2025, as compared to $30.2 million in the second quarter of 2024. The year-over-year increase was primarily due to increased costs associated with drug formulation and development costs chemistry, manufacturing and controls (CMC) for RM-718 and bivamelagon, increased clinical trial costs and higher costs associated with increased headcount. SG&A Expenses: SG&A expenses were $45.9 million for the second quarter of 2025, as compared to $36.4 million for the second quarter of 2024. The year-over-year increase was primarily due to higher costs associated with additional headcount to support expanding business operations and to establish commercial operations in international regions, increased marketing and promotion costs and increased professional services costs. Other income (expense), net: Other income (expense), net was ($1.0) million for the second quarter of 2025, as compared to $8.7 million for the second quarter of 2024. Other income (expense), net for the second quarter of 2024 included a gain of $8.9 million on settlement of the forward contract associated with the issuance of Rhythm’s convertible preferred stock which did not recur in 2025. In addition, the increase in other expense was partially due to non-cash interest expense associated with the accretion of the deferred royalty obligation and the liability payable to LG Chem, Ltd. offset by foreign currency gains. Net Loss: Net loss attributable to common stockholders was ($48.0) million for the second quarter of 2025, or a net loss per basic and diluted share of ($0.75), as compared to a net loss attributable to common stockholders of ($33.6) million for the second quarter of 2024, or a net loss per basic and diluted share of ($0.55). Year to Date 2025 Financial Results:Revenue: Net product revenues relating to sales of IMCIVREE were $86.2 million for the six months ended June 30, 2025, as compared to $55.0 million for the six months ended June 30, 2024. R&D Expenses: R&D expenses were $79.3 million for the six months ended June 30, 2025, as compared to $158.9 million for the six months ended June 30, 2024. The decrease was primarily due to the R&D expenses incurred in the first quarter of 2024 related to in-process research and development costs totaling $92.4 million associated with the acquisition of LG Chem’s proprietary compound bivamelagon, which did not recur in 2025. That decrease was offset by increased costs associated with drug formulation and development costs for RM-718 and bivamelagon, increased clinical trial costs and higher costs associated with increased headcount. SG&A Expenses: SG&A expenses were $85.0 million for the six months ended June 30, 2025, as compared to $70.8 million for the six months ended June 30, 2024. The increase was primarily due to higher costs associated with additional headcount to support expanding business operations and to establish commercial operations in international regions, and increased marketing and promotion costs. Other income (expense), net: Other income (expense), net was ($3.4) million for the six months ended June 30, 2025, as compared to $7.5 million for the six months ended June 30, 2024. Other income (expense), net for the six months ended June 30, 2024 included a gain of $8.9 million on settlement of the forward contract associated with the issuance of Rhythm’s convertible preferred stock which did not recur in 2025. In addition, the increase in other expense was partially due to non-cash interest expense associated with the accretion of the deferred royalty obligation and the liability payable to LG Chem, Ltd. Net Loss: Net loss attributable to common stockholders was ($98.8) million for the six months ended June 30, 2025, or a net loss attributable to common stockholders per basic and diluted share of ($1.56), as compared to a net loss attributable to common stockholders of ($174.9) million for the six months ended June 30, 2024, or a net loss per basic and diluted share of ($2.89). Financial Guidance: For the year ending December 31, 2025, Rhythm anticipates approximately $285 million to $315 million in Non-GAAP Operating Expenses. Non-GAAP Operating Expenses are derived from: GAAP total operating expenses, inclusive of: SG&A expenses of approximately $135 million to $145 million;R&D expenses of approximately $150 million to $170 million; andExcluding stock-based compensation. Non-GAAP Operating Expenses is defined as GAAP operating expenses excluding stock-based compensation and fixed consideration related to in-licensing (see below under 'Non-GAAP Financial Measures' for more details). Based on its current operating plans, Rhythm expects that its cash, cash equivalents and short-term investments as of June 30, 2025, combined with the net proceeds from the July 2025 offering, will be sufficient to fund the Company’s planned operations for at least 24 months. Conference Call Information Rhythm Pharmaceuticals will host a live conference call and webcast at 8:00 a.m. ET today to review its second quarter 2025 financial results and recent business activities. Participants may register for the conference call here. It is recommended that participants join the call ten minutes prior to the scheduled start. A webcast of the call will also be available under 'Events and Presentations' in the Investor Relations section of the Rhythm Pharmaceuticals website at https://ir.rhythmtx.com/. The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the conference call and will be available for 30 days following the call. About Rhythm Pharmaceuticals Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the FDA to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA. Setmelanotide Indication In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In the European Union and the United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology. Limitations of Use Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective: Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benignOther types of obesity not related to BBS or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesityContraindication Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. WARNINGS AND PRECAUTIONSDisturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention. Depression and Suicidal Ideation: Depression, suicidal ideation and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur. Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE. Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation, darkening of pre-existing nevi, development of new melanocytic nevi and increase in size of existing melanocytic nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions. Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including 'gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol preserved drugs. ADVERSE REACTIONS Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection. USE IN SPECIFIC POPULATIONS Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe. Please see the full Prescribing Information for additional Important Safety Information.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 safety, efficacy, potential benefits of, and clinical design or progress of any of our products or product candidates at any dosage or in any indication, including, setmelanotide, bivamelagon, and RM-718; the potential use of setmelanotide in patients with acquired hypothalamic obesity; the commercial growth of IMCIVREE; our expectations surrounding potential regulatory submissions, progress, or approvals and timing thereof for any of our product candidates, including the anticipated supplemental New Drug Application to the FDA and a Type II variation request to the European Medicines Agency; the estimated market size and addressable population for our drug products, including setmelanotide for the treatment of hypothalamic obesity; the future announcement of data from our ongoing clinical trials, including the Japanese cohort of our Phase 3 trial evaluating setmelanotide for patients with acquired hypothalamic obesity, the substudy evaluating setmelanotide for patients with congenital hypothalamic obesity, the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases; Part C of the Phase 1 trial evaluating RM-718, and the open-label Phase 2 trial evaluating setmelanotide in patients with Prader-Willi syndrome; the ongoing enrollment in our clinical trials; the Company’s business strategy and plans; our anticipated financial performance and financial position for any period of time, including estimated Non-GAAP Operating Expenses for the year ending December 31, 2025; the sufficiency of our cash, cash equivalents and short-term investments to fund our operations; and the timing of any of the foregoing. Statements using words such as 'expect”, 'anticipate”, 'believe”, 'may”, 'will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, risks associated with the laws and regulations governing our international operations and the costs of any related compliance programs, our ability to successfully commercialize setmelanotide, our liquidity and expenses, our ability to retain our key employees and consultants, and to attract, retain and motivate qualified personnel, and general economic conditions, and the other important factors, including those discussed under the caption 'Risk Factors” in Rhythm’s Quarterly Report on Form 10-Q for the three months ended June 30, 2025 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this press release or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise. Non-GAAP Financial Measures This press release includes Non-GAAP Operating Expenses, a supplemental measure of our performance that is not required by, or presented in accordance with, U.S. GAAP and should not be considered as an alternative to operating expenses or any other performance measure derived in accordance with GAAP. We define Non-GAAP Operating Expenses as GAAP operating expenses excluding stock-based compensation and fixed consideration related to in-licensing. We caution investors that amounts presented in accordance with our definition of Non-GAAP Operating Expenses may not be comparable to similar measures disclosed by our competitors because not all companies and analysts calculate this non-GAAP financial measure in the same manner. We present this non-GAAP financial measure because we consider it to be an important supplemental measure of our performance and believe it is frequently used by securities analysts, investors, and other interested parties in the evaluation of companies in our industry. Management believes that investors’ understanding of our performance is enhanced by including this non-GAAP financial measure as a reasonable basis for comparing our ongoing results of operations. Management uses this non-GAAP financial measure for planning purposes, including the preparation of our internal annual operating budget and financial projections; to evaluate the performance and effectiveness of our operational strategies; and to evaluate our capacity to expand our business. This non-GAAP financial measure has limitations as an analytical tool, and should not be considered in isolation, or as an alternative to, or a substitute for operating expenses or other financial statement data presented in accordance with GAAP in our consolidated financial statements. Rhythm has not provided a quantitative reconciliation of forecasted Non-GAAP Operating Expenses to forecasted GAAP operating expenses because the Company is unable, without making unreasonable efforts, to calculate the reconciling item, stock-based compensation expenses, with confidence. This item, which could materially affect the computation of forward-looking GAAP operating expenses, is inherently uncertain and depends on various factors, some of which are outside of Rhythm's control. Corporate Contact: David Connolly Head of Investor Relations and Corporate Communications Rhythm Pharmaceuticals, Inc. 857-264-4280 dconnolly@rhythmtx.comMedia Contact: Layne Litsinger Real Chemistry 410-916-1035 llitsinger@realchemistry.comRhythm Pharmaceuticals, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(Unaudited) Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Revenues: Product revenue, net$48,502 $29,078 $86,220 $55,045 License revenue - - (5,014) - Total revenues 48,502 29,078 81,206 55,045 Costs and expenses: Cost of sales 5,543 2,947 9,191 5,753 Research and development 42,308 30,194 79,281 158,858 Selling, general, and administrative 45,947 36,415 85,034 70,797 Total costs and expenses 93,798 69,556 173,506 235,408 Loss from operations (45,296) (40,478) (92,300) (180,363)Other income (expense): Other income (expense), net 1,576 302 932 824 Gain on settlement of forward contract - 8,900 - 8,900 Interest expense (5,817) (4,603) (11,226) (9,358)Interest income 3,242 4,097 6,881 7,143 Total other (expense), net (999) 8,696 (3,413) 7,509 Loss before income taxes (46,295) (31,782) (95,713) (172,854)Provision for income taxes 337 479 417 779 Net loss$(46,632) $(32,261) $(96,130) $(173,633)Accrued dividends on convertible preferred stock (1,349) (1,302) (2,671) (1,302)Net loss attributable to common stockholders$(47,981) $(33,563) $(98,801) $(174,935)Net loss per share attributable to common stockholders, basic and diluted$(0.75) $(0.55) $(1.56) $(2.89) Weighted-average common shares outstanding, basic and diluted 63,684,359 61,011,824",
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"snippet": "-- Second quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of $48.5 million ---- U.S. and EU regulatory submissions for setmelan...",
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"description": "On track to submit a Biologics License Application (BLA) for accelerated approval of atacicept to U.S. FDA in Q4 2025; potential commercial launch in 2026Announced positive primary endpoint results from the ongoing ORIGIN Phase 3 trialInitiated the PIONEER trial to investigate atacicept in a broader IgAN patient cohort and multiple autoimmune glomerular diseasesExpected to present full primary endpoint results from the ORIGIN 3 trial at a medical congress in Q4 2025 BRISBANE, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the second quarter ended June 30, 2025. 'Our team delivered exciting new clinical results from our pivotal ORIGIN 3 trial in the second quarter of 2025, which were consistent with or better than our previous trials for atacicept in patients with IgAN. Based on the strength of the overall data accumulated for atacicept over the past few years, we are excited to move ahead with our BLA submission to the U.S. FDA for accelerated approval. We anticipate submitting the BLA in the fourth quarter of 2025, with an expected commercial launch in 2026,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. 'Atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor. We are thrilled for the potential of atacicept as a possible disease-modifying therapy to address the unmet medical needs of IgAN patients.” Second Quarter 2025 and Recent Business Highlights Announced positive 36-week data from the ongoing pivotal ORIGIN 3 trial of atacicept in patients with IgA Nephropathy (IgAN), including: 46% reduction from baseline in proteinuria for participants treated with atacicept, as measured by 24-hour urine protein-to-creatinine ratio (UPCR); primary endpoint achieved with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (pAtacicept-treated participants demonstrated results across other prespecified endpoints that were consistent with or better than those previously observed in the ORIGIN Phase 2b trialSafety profile of atacicept across ORIGIN program appears favorable, and comparable to placeboCompleted full enrollment in the ongoing ORIGIN 3 trialEnrolling participants in the ORIGIN Extend study, which provides ORIGIN study participants with extended access to atacicept until commercial availability in their region, and captures longer-term safety and efficacy dataInitiated the PIONEER trial to evaluate atacicept in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy (pMN), and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patientsStrengthened the Company’s financial positioning with a new credit facility of up to $500 million of term loans with existing partner Oxford Finance LLC, extending the Company’s cash runway well beyond potential commercial launch of ataciceptAnticipated Upcoming MilestonesSubmission of a BLA for atacicept in IgAN to the U.S. FDA in Q4 2025 for accelerated approval; potential commercial launch in 2026Presentation of the full 36-week results from the pivotal ORIGIN 3 trial expected at a medical congress in Q4 2025Initial results from the PIONEER Phase 2 basket trial expected in Q4 2025Pivotal ORIGIN 3 study expected to be completed in 2027Financial Results for the Quarter Ended June 30, 2025 For the quarter ended June 30, 2025, Vera reported a net loss of $76.5 million, or a net loss per diluted share of $1.20, compared to a net loss of $33.7 million, or a net loss per diluted share of $0.62, for the quarter ended June 30, 2024. During the six months ended June 30, 2025, net cash used in operating activities was $109.2 million, compared to $58.6 million for the same period last year. Vera reported $556.8 million in cash, cash equivalents, and marketable securities as of June 30, 2025, which combined with its undrawn debt facility, Vera believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept and beyond. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN, other autoimmune kidney diseases and lupus nephritis. The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different disease areas. About Vera Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit www.veratx.comForward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are 'forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera’s plans to submit a Biologics License Application to the U.S. FDA for accelerated approval and to potentially receive FDA approval for atacicept in IgAN and launch it commercially, present full primary endpoint results from the ORIGIN 3 trial at a medical congress, obtain initial results from the PIONEER Phase 2 basket trial, and complete the ORIGIN 3 study, as well as statements regarding the timing of each such event; the ability of atacicept to advance the standard of care in IgAN and to address the unmet medical needs of IgAN patients; Vera’s ability to fund its operations through potential approval and U.S. commercial launch of atacicept; and Vera’s plans, commitments, aspirations and goals under the caption 'About Vera”. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'believe,” 'plan,” 'potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.For more information, please contact:Investor Contact: Joyce Allaire LifeSci Advisors 212-915-2569 jallaire@lifesciadvisors.comMedia Contact: Debra Charlesworth Vera Therapeutics 415-854-8051 corporatecommunications@veratx.comVERA THERAPEUTICS, INC.Condensed Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)(Unaudited) Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024 Operating expenses: Research and development$58,195 $29,311 $99,473 $52,511 General and administrative 21,946 8,032 37,862 15,944 Total operating expenses 80,141 37,343 137,335 68,455 Loss from operations (80,141) (37,343) (137,335) (68,455)Other income, net 3,610 3,635 9,110 6,364 Net loss$(76,531) $(33,708) $(128,225) $(62,091)Change in unrealized gain/loss on marketable securities$(127) $(277) $134 $(700)Comprehensive loss$(76,658) $(33,985) $(128,091) $(62,791)Net loss per share attributable to common stockholders, basic and diluted$(1.20) $(0.62) $(2.01) $(1.17)Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 63,789,303 54,728,552 63,730,756 52,850,242 VERA THERAPEUTICS, INC.Condensed Balance Sheets(in thousands) June 30, December 31, 2025 2024 (unaudited) Assets Current assets: Cash, cash equivalents and marketable securities$556,827 $640,852 Prepaid expenses and other current assets 14,527 10,366 Total current assets 571,354 651,218 Operating lease right-of-use assets 2,471 3,372 Other noncurrent assets 4,703 1,091 Total assets$578,528 $655,681 Liabilities and stockholders' equity Current liabilities: Accounts payable$13,157 $7,665 Operating lease liabilities 855 1,483 Accrued expenses and other liabilities, current 19,542 16,223 Total current liabilities 33,554 25,371 Long-term debt 74,464 50,687 Operating lease liabilities, noncurrent 2,233 2,468 Total liabilities 110,251 78,526 Stockholders' equity Common stock 64 64 Additional paid-in-capital 1,057,161 1,037,948 Accumulated other comprehensive income 527 393 Accumulated deficit (589,475) (461,250)Total stockholders' equity 468,277 577,155 Total liabilities and stockholders' equity$578,528 $655,681 **media[700203]**",
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"title": "Knight Therapeutics Announces Regulatory Submission of CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules in Mexico",
"description": "MONTREAL, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ('Knight') a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., has submitted a marketing authorization application for CREXONT® to COFEPRIS, the Mexican health regulatory agency, for the treatment of Parkinson’s disease (PD), post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults. CREXONT® is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson’s disease. In January 2024, Knight announced that it had entered into an agreement with Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ('Amneal') for the exclusive rights to seek regulatory approval and commercialize CREXONT® in Canada and Latin America. In July 2025, Knight announced that CREXONT® submission was accepted for review by Health Canada. 'This submission of CREXONT® in Mexico demonstrates Knight’s continued execution of our strategy to expand our neurology portfolio,” said Samira Sakhia, President and Chief Executive Officer of Knight. 'There is a high unmet medical need in the treatment of Parkinson’s disease, and we are confident that, with CREXONT®, we will be bringing a much-needed novel treatment option to Parkinson’s patients.” About CREXONT® CREXONT® is a novel, oral formulation of carbidopa/levodopa (CD/LD) capsule that combines both immediate-release granules and extended-release beads for the treatment of Parkinson’s disease. CREXONT® contains immediate-release (IR) granules and extended-release (ER) coated beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of LD, coated with a sustained release polymer to allow for gradual drug release, a mucoadhesive polymer designed to prolong adhesion at absorption site, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach. CREXONT® was studied in the RISE-PD clinical study which was a 20-week, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial with 630 patients. The RISE-PD study successfully met its primary and secondary endpoints, demonstrating that treatment with CREXONT® significantly improved daily 'Good On' time with fewer doses compared to IR CD/LD. Specifically, CREXONT® showed an improvement of 0.53 hours (least squares mean, 95% CI, 0.09-0.97), with an average dosing frequency of three times per day versus five times per day for IR CD/LD1. A post-hoc analysis of the primary endpoint on a per dose basis showed 1.55 more hours of 'Good On” time per dose of CREXONT, compared to IR CD/LD.2 About Parkinson’s disease Parkinson’s disease has become the fastest growing neurological disorder worldwide, with approximately 1 million patients diagnosed in the U.S.3,4 In Mexico, the Parkinson’s Movement Disorders Clinic at Manuel Velasco Suárez National Institute of Neurology and Neurosurgery estimates that 500,000 people between the ages of 45 and 60 are affected by the illness5. Parkinson’s disease is characterized by slowness of movement, stiffness, resting tremor and impaired balance6. While Parkinson’s disease is not considered a fatal disease, it is associated with significant morbidity and disability7. The average age at diagnosis for patients with Parkinson‘s disease is 60; as people live longer, the number of patients living with Parkinson’s disease is predicted to grow significantly over the coming decades.3,8 About Knight Therapeutics Inc. Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight’s Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca. Forward-Looking Statement This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2024, as filed on www.sedarplus.ca. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law. References 1 Hauser RA et al. JAMA Neurol. 2023 Oct 1;80(10):1062-1069. 2 Hauser RA et al. Neurology 2022;98 (supplement 18). 3 Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10. 4 Marras et al. NPJ Parkinsons Dis. 2018;4:21. 5 Secretaría de Salud. Enfermedad de Parkinson, segundo lugar entre los padecimientos neurodegenerativos. Gobierno de México. Published April 11, 2018. Accessed March 27, 2025. https://www.gob.mx/salud/prensa/095-enfermedad-de-parkinson-segundo-lugar-entre-los-padecimientos-neurodegenerativos 6 NINDS. Parkinson’s disease: challenges, progress, and promise. Reviewed August 2019. Accessed April 16, 2021. 7 Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014. 8 John Hopkins Medicine. Young-Onset Parkinson’s disease. Accessed August 17, 2021. CONTACT INFORMATION:Investor Contact: Knight Therapeutics Inc. Samira Sakhia Arvind UtchanahPresident & Chief Executive Officer Chief Financial OfficerT: 514.484.4483 T. +598.2626.2344F: 514.481.4116 Email: IR@knighttx.com Email: IR@knighttx.comWebsite: www.knighttx.com Website: www.knighttx.com**media[700289]**",
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"description": "Webcast and Conference Call To be Held Tuesday, August 12, 2025, 8:30 am ET NEW YORK, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ('Anavex” or the 'Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it will issue financial results for its third fiscal quarter on Tuesday, August 12, 2025. Management will host a conference call on Tuesday, August 12, at 8:30 am ET to review financial results and provide an update on the execution of the Company’s growth strategy. Following management’s remarks, there will be a question-and-answer session. Webcast / Conference Call Information: The live webcast of the conference call will be available on Anavex’s website at www.anavex.com. The conference call can be also accessed by dialing 1 929 205 6099 for participants in the U.S. using the Meeting ID# 856 5033 5285 and reference passcode 014 352. A replay of the conference call will also be available on Anavex’s website for up to 30 days. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter,Facebook, Instagram, and LinkedIn. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. For Further Information: Anavex Life Sciences Corp. Research & Business Development Toll-free: 1-844-689-3939 Email: info@anavex.comInvestors: Andrew J. Barwicki Investor Relations Tel: 516-662-9461 Email: andrew@barwicki.com**media[700285]**",
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"title": "Ocular Therapeutix™ Reports Second Quarter 2025 Financial Results and Business Highlights",
"description": "Outstanding patient retention and clinical execution in complementary AXPAXLI™ SOL trials for wet AMDSOL-1 remains on track for 1Q 2026 topline data SOL-R rescue criteria streamlined and simplified with topline data expected in 1H 2027Planning to incorporate single long-term extension study for both SOL trialsOcular to host Investor Day on Tuesday, September 30, 2025, in New York City Raised gross proceeds of approximately $97 million in June 2025 through existing ATM facilityCash balance of $391.1 million as of June 30, 2025, with expected runway into 2028, well beyond anticipated topline data for SOL-1 and SOL-R BEDFORD, Mass., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, 'Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today reported financial results for the second quarter ended June 30, 2025, and provided recent business highlights. 'We are entering the most important phase of Ocular Therapeutix’s history, marked by consistent execution, growing clinical conviction, and a clear roadmap to redefine the retina treatment landscape,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. 'With SOL-1 on track for topline data in the first quarter of 2026, followed by SOL-R topline data in the first half of 2027, we are building what we expect to be a powerful and highly differentiated clinical profile for AXPAXLI. Due to our increasing confidence and conviction in AXPAXLI’s potential, we are now planning a long-term, open-label extension study for patients completing either of the SOL trials, and we are advancing SOL-R with streamlined and simplified rescue criteria that better reflect real-world practice. SOL-1 and SOL-R are thoughtfully crafted, complementary trials with bespoke patient populations designed to de-risk outcomes and answer key questions physicians will have on the durability, flexibility, and repeatability of AXPAXLI. As a result of this clinical strategy, AXPAXLI has the potential to secure an unprecedented superiority label in wet AMD. Recently approved anti-VEGF products and current competitive Phase 3 wet AMD trials are all based on non-inferiority to aflibercept (2 mg). To our knowledge, SOL-1 is the only Phase 3 superiority trial being conducted in wet AMD, and if we are successful in gaining FDA approval, we will potentially be the only product with a superiority claim in the label for the foreseeable future. We further expect the SOL program to enable dosing every 6 months to as infrequently as every 12 months. We believe this dynamic will allow us a unique and potentially dominant position compared to all other products in the commercial landscape, and could unlock an opportunity that spans millions of patients worldwide - addressing the critical needs for a more sustainable, less burdensome treatment, with potentially improved long-term outcomes.” Dr. Dugel continued, 'Beyond wet AMD, we are thrilled with the FDA feedback supporting our NPDR and DME program, and we look forward to sharing more details at our Investor Day in September, along with the global commercial outlook for AXPAXLI and more. Our refreshed corporate branding, launched in June, reflects the Company we’ve become: retina-focused, patient-driven, and boldly advancing a potential new standard-of-care in retinal disease.” Recent Achievements and Upcoming Milestones:SOL-1 (Phase 3, wet AMD) retention and protocol adherence continues to be exceptional as topline data remains on track for 1Q 2026. Patient engagement and investigator adherence to the study rescue protocol continue to be outstanding in the SOL-1 superiority study. Ocular plans to continue to follow patients completing the trial through a long-term extension study. SOL-R (Phase 3, wet AMD) rescue criteria streamlined and simplified with topline data expected in 1H 2027. The SOL-R non-inferiority study is the largest tyrosine kinase inhibitor (TKI) trial to date in retina. Based on investigator feedback, and as part of its ongoing effort to ensure SOL-R reflects real-world clinical decision-making, Ocular has streamlined and simplified the rescue criteria to a >5-letter loss in visual acuity plus a ≥75-micron increase in central subfield thickness (CSFT). This change aligns the trial more closely with how physicians determine when to intervene in the real world in the most conservative manner. This change was not an FDA requirement, but rather a strategic decision to further bridge the gap between clinical trial design and clinical practice. SOL-R remains robustly powered at 90% with the non-inferiority margin of -4.5 ETDRS letters per FDA guidance. SOL-R has completed enrollment and, based on its projected randomization timeline, Ocular expects to report topline data in 1H 2027. New Drug Application (NDA) filing for FDA review planned for shortly after topline results in SOL-R. Because axitinib is FDA-approved for non-ophthalmic indications, the Company plans to leverage the 505(b)(2) NDA review pathway which has the potential to shorten the review timeline for AXPAXLI by two months compared to the traditional review pathway for new molecular entities. The FDA has previously communicated that SOL-1 and SOL-R should be appropriate for use as adequate and well-controlled studies to support a potential NDA and product label for wet AMD. If approved, Ocular believes AXPAXLI has the potential to be the first product for wet AMD with a superiority label based on the SOL-1 trial, with redosing potentially as infrequently as every 12 months. The Company plans to incorporate a single long-term, open-label extension study for both SOL trials. Subjects will be eligible to enter the extension study after completing the two-year safety follow-up period in either SOL-1 or SOL-R. In addition to providing long-term safety data, the study is expected to further inform the AXPAXLI treatment paradigm and potentially provide several commercial advantages. The extension study is designed to evaluate long-term safety and explore key efficacy outcomes such as vision preservation, anti-fibrotic activity, and the potential consequences of delaying AXPAXLI treatment in control arm patients. Written feedback received from FDA on registrational trial in non-proliferative diabetic retinopathy (NPDR) for AXPAXLI. Building on FDA’s positive feedback received earlier this year, Ocular is actively engaged in defining its clinical strategy for AXPAXLI in NPDR and diabetic macular edema (DME). The Company plans to provide more details surrounding its clinical trial strategy and design at its upcoming Investor Day on September 30, 2025. Opportunistically raised gross proceeds of approximately $97 million in June 2025 through existing at-the-market (ATM) facility. This additional capital provides Ocular with financial flexibility as the Company prepares for data from its first registrational trial in wet AMD, SOL-1, in the first quarter of 2026. Ocular remains well-financed with expected runway well beyond the anticipated receipt of SOL-1 and SOL-R topline data and into 2028. Investor Dayto be heldthe afternoon of Tuesday, September 30, 2025, in New York City. The event will feature prominent retinal disease Key Opinion Leaders (KOLs) and presentations from senior Company leadership. Key areas of focus include: an overview of the complementary SOL trials and how they may support a differentiated superiority label for AXPAXLI in wet AMD; new details on the planned SOL extension study; the clinical strategy for NPDR and DME informed by recent FDA feedback; and a review of the global commercial opportunity for AXPAXLI across retinal indications. Additional event logistics and webcast information will be provided in advance. To register for Ocular’s Investor Day, please visit Ocular’s website or register HERE. Unveiled new corporate branding in June 2025 reflecting Ocular’s transformation to a retina-focused company. Ocular aims to redefine the retina experience by reducing the treatment burden and providing an alternative to the pulsatile nature of available treatments, in hopes of preserving vision for the long-term. The Company’s new branding reflects Ocular’s meaningful progress, driven by the momentum of its SOL trials and its commitment to patients. Second Quarter Ended June 30, 2025, Financial Results:Total cash and cash equivalents were $391.1 million as of June 30, 2025. Based on current plans and related estimates of anticipated cash inflows from DEXTENZA®, the Company believes that its current cash balance is sufficient to support its planned expenses, debt service obligations, and capital expenditure requirements into 2028. This cash projection does not yet factor in the full impact of potential clinical trial activities for AXPAXLI in NPDR and DME or the long-term extension study in wet AMD, as Ocular is currently in the planning phases for these programs. Total net revenue was $13.5 million for the second quarter of 2025, an 18.1% decrease as compared to total net revenue of $16.4 million in the comparable quarter in 2024. Total net revenue includes both gross DEXTENZA product revenue, net of discounts, rebates, and returns, which the Company refers to as net product revenue, and collaboration revenue. DEXTENZA end-user unit sales were up 5% compared to the second quarter in 2024, however the reduction in net revenue was due to an evolving and significantly more challenging reimbursement environment for DEXTENZA in 2025. Strong execution by the Ocular commercial team has ensured the demand for DEXTENZA continues to grow, as evidenced by sustained unit growth. Compared to the first quarter of 2025, DEXTENZA net product revenue increased by 26.0% in the second quarter of 2025. Research and development expenses for the second quarter of 2025 were $51.1 million versus $28.9 million for the comparable quarter in 2024, reflecting an increase in overall clinical expenses associated with the SOL-1 and SOL-R Phase 3 clinical trials, as well as additional personnel and professional services to support these clinical trials. Selling and marketing expenses were $13.7 million for the second quarter of 2025, as compared to $10.0 million for the comparable quarter of 2024, primarily reflecting an increase in personnel-related costs, including stock-based compensation expense, and professional fees associated with pre-commercialization activities for AXPAXLI. General and administrative expenses were $14.3 million for the second quarter of 2025, as compared to $19.7 million for the comparable quarter of 2024, primarily due to a decrease in personnel-related costs, including stock-based compensation expense. The second quarter of 2024 includes one-time personnel-related costs, including stock-based compensation expense, for certain employees who departed the Company, and restructuring costs. Net loss for the second quarter of 2025 was $(67.8) million, or a net loss of $(0.39) per share on both a basic and diluted basis, compared to a net loss of $(43.8) million, or a net loss of $(0.26) per share on a basic and diluted basis, for the comparable quarter of 2024. The net loss in the second quarter of 2025 includes a net loss from the change in fair value of our derivative liability of $(0.6) million, which is comprised of a non-cash loss from fair value measurement of the derivative liability associated with the Barings Credit Facility of $(0.2) million, and expense related to actual royalty fees under the Barings Credit Facility of $(0.5) million, compared to a $(3.0) million net loss for the second quarter of 2024, which is comprised of a net non-cash loss attributable to fair value measurements of the derivative liabilities associated with the Barings Credit Facility and the Company's convertible notes of $(2.5) million, and expense related to actual royalty fees under the Barings Credit Facility of $(0.6) million. Outstanding shares as of August 1, 2025, were approximately 174.0 million. Conference Call and Webcast Information: Ocular Therapeutix will host a conference call and webcast on Tuesday, August 5, 2025, at 8:00 AM ET to discuss recent business progress and financial results for the second quarter ended June 30, 2025. To access the call, please dial: 1-877-407-9039 (U.S.) or 1-201-689-8470 (International). The live and archived webcast can also be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section of the Investor Relations page. A replay of the webcast will be archived for at least 30 days. About AXPAXLI AXPAXLI™ (also known as OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD, diabetic retinopathy, diabetic macular edema, and other retinal diseases. About the SOL-1 Study The registrational Phase 3 SOL-1 trial (NCT06223958) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1), parallel group study that involves more than 100 clinical trial sites located in the U.S. and Argentina. In December 2024, the trial completed randomization of 344 evaluable treatment-naïve subjects with a diagnosis of wet AMD in the study eye. The superiority study has an eight-week loading segment prior to randomization. During the loading segment, subjects who have 20/80 vision or better and who satisfy other enrollment criteria receive two doses of aflibercept (2 mg) at Week -8 and Week -4. Eligible subjects who achieve best corrected visual acuity (BCVA) of 20/20 at Day 1 or gain at least 10 early treatment diabetic retinopathy study (ETDRS) letters at Day 1 are then randomized to receive a single dose of AXPAXLI or a single dose of aflibercept (2 mg). At Week 52 and at Week 76, all subjects are re-dosed with their respective initial treatment of AXPAXLI or aflibercept (2 mg). Subjects will be followed for safety until the end of Year 2. Throughout the study, subjects are assessed monthly. Trial subjects and designated study personnel will remain masked through the end of Year 2. The clinical trial protocol requires that, during the study, subjects in either arm meeting pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg). The primary endpoint of SOL-1 is the proportion of subjects who maintain visual acuity, defined as a loss of About the SOL-R Study The registrational Phase 3 SOL-R trial (NCT06495918) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (2:2:1), three-arm study that includes sites located in the U.S., Argentina, India, and Australia. The trial is intended to randomize approximately 555 subjects who are treatment-naïve or were diagnosed with wet AMD in the study eye within about four months prior to enrollment. This non-inferiority trial reflects a patient enrichment strategy over the six months prior to randomization that includes three screening doses of any anti-VEGF therapy, excluding brolucizumab-dbll, and monitoring to exclude those subjects with significant retinal fluid fluctuations. Subjects that continue to meet eligibility will enter a run-in period and receive two loading doses of aflibercept (2 mg) prior to Day 1. Subjects in the first arm receive a single dose of AXPAXLI at Day 1 and are re-dosed at Weeks 24, 48, and 72. Subjects in the second arm receive aflibercept (2 mg) on-label every eight weeks. Subjects in the third arm receive a single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Weeks 24, 48, and 72, aligned with the AXPAXLI treatment arm for adequate masking. Subjects will be followed for safety until the end of Year 2. Throughout the study, subjects are assessed monthly. Trial subjects and designated study personnel will remain masked through the end of Year 2. Subjects in any arm that meet pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg). The pre-specified rescue criteria include a >5-letter loss in visual acuity plus a ≥75-micron increase in central subfield thickness (CSFT). The primary endpoint of SOL-R is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms at Week 56. As per the protocol agreed to by the FDA, the non-inferiority margin for the lower bound is -4.5 letters of mean BCVA when compared to aflibercept (2 mg) dosed every eight weeks. In a written Type C response received in August 2024, and a subsequent written response received in December 2024, the FDA agreed that the SOL-R repeat dosing wet AMD study, with a primary endpoint at Week 56, should be appropriate as an adequate and well-controlled study in support of a potential New Drug Application and product label for wet AMD. About Wet AMD Wet age-related macular degeneration (wet AMD) is a leading cause of severe, irreversible vision loss affecting approximately 14.5 million individuals globally and 1.8 million in the United States alone (2024 Market Scope® Retinal Pharmaceuticals Market Report). Wet AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF). Without prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss. With proper treatment, patients may maintain visual function for a period of time and may temporarily regain lost vision. Challenges with current therapies include pulsatile, repeated intraocular injections, treatment-related adverse events and up to 40% patient discontinuation within one year of initiating treatment with continued disease progression. Taken together, these factors lead to undertreatment and a lack of long-term vision improvement for patients. About Ocular Therapeutix, Inc. Ocular Therapeutix, Inc. is an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (also known as OTX-TKI), Ocular’s investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD). Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel that is currently in a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Explore the new corporate branding and follow the Company on its website, LinkedIn, or X. DEXTENZA® is a registered trademark of Ocular Therapeutix, Inc. The Ocular Therapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc. Forward-Looking Statements Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA; the development, regulatory status of and regulatory submissions regarding the Company’s product candidates; the design and conduct of, and the timing of the screening, enrollment and randomization of patients in and the availability of data from the Company’s SOL-1 and SOL-R Phase 3 clinical trials of AXPAXLI (also known as OTX-TKI) for the treatment of wet AMD; the Company’s plans to advance the development of AXPAXLI, including in additional indications such as NPDR and DME and in the Company’s planned long-term extension study, and its plans to advance other product candidates; the potential utility or adoption, if approved, of any of the Company’s product candidates; the Company’s cash runway and the sufficiency of the Company’s cash resources; and other statements containing the words 'anticipate”, 'believe”, 'estimate”, 'expect”, 'intend”, 'designed”, 'goal”, 'may”, 'might”, 'plan”, 'predict”, 'project”, 'target”, 'potential”, 'will”, 'would”, 'could”, 'should”, 'continue”, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing any product or product candidate that receives regulatory approval; the ability to retain regulatory approval of any product or product candidate that receives regulatory approval; the ability to maintain and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA; the initiation, design, timing, conduct and outcomes of ongoing and planned clinical trials; the risk that the FDA will not agree with the Company’s interpretation of the written agreement under the Special Protocol Assessment for the SOL-1 trial; the risk that the FDA may not agree that the protocol and statistical analysis plan of SOL-R or that the data generated by the SOL-1 and SOL-R trials support marketing approval, even if the trials are successful; the risk that the Company and the FDA may not agree on the registrational pathway for any of its product candidates; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier trials, whether preliminary or interim data from a clinical trial (including masked safety or masked rescue data from the Company’s SOL-1 trial) will be predictive of final data from such trial, or whether data from a clinical trial assessing a product candidate for one indication will be predictive of results in other indications; uncertainty as to whether data from the Company’s planned long-term, open-label extension study in wet AMD will demonstrate clinically meaningful, long-term benefits; uncertainties regarding the potential commercial advantages and/or position of the Company’s product candidates; availability of data from clinical trials and expectations for regulatory submissions and approvals; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; the Company’s existing indebtedness and the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; and other factors discussed in the 'Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Investors & Media Ocular Therapeutix, Inc. Bill Slattery Vice President, Investor Relations bslattery@ocutx.com Ocular Therapeutix, Inc.Consolidated Balance Sheets(in thousands, except share and per share data) June 30, December 31, 2025 2024Assets Current assets: Cash and cash equivalents $391,134 $392,102 Accounts receivable, net 30,412 32,388 Inventory 3,039 3,040 Prepaid expenses and other current assets 8,790 13,457 Total current assets 433,375 440,987 Property and equipment, net 10,461 9,389 Restricted cash 1,614 1,614 Operating lease assets 5,883 5,945 Total assets $451,333 $457,935 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $5,889 $4,176 Accrued expenses and other current liabilities 34,417 35,117 Deferred revenue - 128 Operating lease liabilities 2,625 1,933 Total current liabilities 42,931 41,354 Other liabilities: Operating lease liabilities, net of current portion 4,408 5,345 Derivative liability 14,024 13,246 Deferred revenue, net of current portion 14,000 14,000 Notes payable, net 69,906 68,505 Other non-current liabilities 148 141 Total liabilities 145,417 142,591 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at June 30, 2025 and December 31, 2024, respectively - - Common stock, $0.0001 par value; 400,000,000 shares and 400,000,000 shares authorized and 172,925,389 and 157,749,490 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively 17 16 Additional paid-in capital 1,328,850 1,206,412 Accumulated deficit (1,022,951) (891,084)Total stockholders’ equity 305,916 315,344 Total liabilities and stockholders’ equity $451,333 $457,935 Ocular Therapeutix, Inc.Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data) Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024Revenue: Product revenue, net$13,395 $16,379 $24,028 $31,094 Collaboration revenue 64 62 128 121 Total revenue, net 13,459 16,441 24,156 31,215 Costs and operating expenses: Cost of product revenue 1,944 1,509 3,206 2,835 Research and development 51,081 28,857 93,938",
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"description": "- Earnings Call Scheduled for 8:00 a.m. ET on August 19, 2025 - GUANGZHOU, China, Aug. 05, 2025 (GLOBE NEWSWIRE) -- XPeng Inc. ('XPENG” or the 'Company,” NYSE: XPEV and HKEX: 9868), a leading Chinese smart electric vehicle ('Smart EV”) company, today announced that it will report its second quarter 2025 unaudited financial results on Tuesday, August 19, 2025, before the open of U.S. markets. The Company’s management will host an earnings conference call at 8:00 AM U.S. Eastern Time on August 19, 2025 (8:00 PM Beijing/Hong Kong Time on August 19, 2025). For participants who wish to join the call by phone, please access the link provided below to complete the pre-registration and dial in 5 minutes prior to the scheduled call start time. Upon registration, each participant will receive dial-in details to join the conference call. Event Title:XPENG Second Quarter 2025 Earnings Conference CallPre-registration link:https://s1.c-conf.com/diamondpass/10049063-j9us45.html Additionally, a live and archived webcast of the conference call will be available on the Company’s investor relations website at http://ir.xiaopeng.com. A replay of the conference call will be accessible approximately an hour after the conclusion of the call until August 26, 2025, by dialing the following telephone numbers: United States:+1-855-883-1031International:+61-7-3107-6325Hong Kong, China:800-930-639China Mainland:400-120-9216Replay PIN:10049063 About XPENG XPENG is a leading Chinese Smart EV company that designs, develops, manufactures, and markets Smart EVs that appeal to the large and growing base of technology-savvy middle-class consumers. Its mission is to drive Smart EV transformation with technology, shaping the mobility experience of the future. In order to optimize its customers’ mobility experience, XPENG develops in-house its full-stack advanced driver-assistance system technology and in-car intelligent operating system, as well as core vehicle systems including powertrain and the electrical/electronic architecture. XPENG is headquartered in Guangzhou, China, with main offices in Beijing, Shanghai, Shenzhen, Silicon Valley and San Diego. The Company’s Smart EVs are mainly manufactured at its plants in Zhaoqing and Guangzhou, Guangdong province. For more information, please visit https://www.xpeng.com/. For Investor Enquiries: IR Department XPeng Inc. E-mail: ir@xiaopeng.com Jenny Cai Piacente Financial Communications Tel: +1-212-481-2050 or +86-10-6508-0677 E-mail: xpeng@tpg-ir.com For Media Enquiries: PR Department XPeng Inc. E-mail: pr@xiaopeng.com Source: XPeng Inc. **media[699957]**",
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"description": "Reaffirms Full Year 2025 Guidance BRENTWOOD, Tenn., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Surgery Partners, Inc. (NASDAQ:SGRY) ('Surgery Partners” or the 'Company”), a leading short-stay surgical facility owner and operator, today announced results for the second quarter ended June 30, 2025. Second Quarter 2025 Financial Highlights(All comparisons are year-over-year unless otherwise noted)Revenue increased 8.4% for the second quarter Same-facility revenues increased 5.1% for the second quarterSame-facility cases increased 3.4% for the second quarterNet loss attributable to Surgery Partners, Inc. was $2.5 million for the second quarter Adjusted EBITDA increased 9.0% to $129.0 million for the second quarter2025 GuidanceFull year 2025 revenue and Adjusted EBITDA guidance reaffirmed to be in the range of $3.30 billion to $3.45 billion and $555 million to $565 million, respectively Eric Evans, Chief Executive Officer, stated, 'We are proud to report strong growth in Adjusted EBITDA and revenue, demonstrating the strength of our operational strategy as we capitalize on the continued momentum in the ambulatory surgery industry. Our continued focus on maximizing portfolio performance, optimistic outlook on surgical trends and regulatory landscape, and focus on exceptional clinical quality and value, positions us for continued growth in 2025 and beyond. Our growth is the result of a relentless focus on excellence and differentiation in our core short-stay surgical service lines. In line with our commitment to enhance shareholder value, we are actively evaluating portfolio optimization opportunities to expedite leverage reduction, accelerate cash flow generation and provide increased flexibility to self-fund our growth algorithm following the conclusion of the recent strategic process.” Dave Doherty, Chief Financial Officer, commented, 'The results we report today are very much aligned with our internal expectations and give us confidence in reaffirming our guidance for the full year. Our guidance implies continued margin expansion, reflecting our on-going operating system improvements as well as the integration benefits from recent acquisitions and contributions from de novos we expect to open this year.” Second Quarter 2025 Results Revenues for the second quarter of 2025 increased 8.4% to $826.2 million as compared to $762.1 million for the second quarter of 2024. Same-facility revenues for the second quarter of 2025 increased 5.1% as compared to the same period in prior year, with a 1.6% increase in revenue per case and a 3.4% increase in same-facility cases. For the second quarter of 2025, the Company’s Adjusted EBITDA was $129.0 million, compared to $118.3 million for the same period in 2024. Year-to-Date 2025 Results Revenues year-to-date 2025 increased 8.3% to $1,602.2 million as compared to $1,479.5 million for the 2024 period. Same-facility revenues for year-to-date 2025 increased 5.1% as compared to the prior year, with a 0.4% increase in revenue per case and a 4.7% increase in same-facility cases. For year-to-date 2025, the Company’s Adjusted EBITDA was $232.9 million, compared to $215.8 million for the same period last year. Liquidity Surgery Partners had cash and cash equivalents of $250.1 million and $394.9 million of borrowing capacity under its revolving credit facility as of June 30, 2025. Cash flows from operating activities was $81.3 million for the second quarter of 2025, compared to $82.8 million for the same period in 2024. The period-over-period change is due to operational growth being offset by an increase in cash interest payments. Year-to-date, operating cash flows were $87.3 million compared to $123.5 million in the prior year period. The decrease was primarily driven by higher cash interest payments and timing of changes in working capital. The Company’s ratio of total net debt to EBITDA, as calculated under the Company’s credit agreement, was approximately 4.1x at the end of the second quarter of 2025. Leverage calculated using consolidated debt from our balance sheet divided by Adjusted EBITDA, before reducing it for NCI, was 4.7x times. Conference Call Information Surgery Partners will hold a conference call today, August 5, 2025 at 8:30 a.m. (Eastern Time). The conference call can be accessed live over the phone by dialing 1-844-826-3033, or for international callers, 1-412-317-5185. A replay will be available three hours after the call and can be accessed by dialing 1-844-512-2921, or for international callers, 1-412-317-6671. The passcode for the live call and the replay is 10201328. The replay will be available until August 19, 2025. Interested investors and other parties may also listen to a simultaneous webcast of the conference call by logging onto the Investor Relations section of the Company's website at www.surgerypartners.com. The replay will also be available on this same website for a limited time following the call. To learn more about Surgery Partners, please visit the Company's website at www.surgerypartners.com. Surgery Partners uses its website as a channel of distribution for material Company information. Financial and other material information regarding Surgery Partners is routinely posted on the Company's website and is readily accessible. About Surgery Partners Headquartered in Brentwood, Tennessee, Surgery Partners is a leading healthcare services company with a differentiated outpatient delivery model focused on providing high quality, cost effective solutions for surgical and related ancillary care in support of both patients and physicians. Founded in 2004, Surgery Partners is one of the largest and fastest growing surgical services businesses in the country, with more than 200 locations in 30 states, including ambulatory surgery centers, surgical hospitals, multi-specialty physician practices and urgent care facilities. For additional information, visit www.surgerypartners.com. Forward-Looking Statements This press release contains forward-looking statements, including those regarding growth, our anticipated operating results for future periods and other similar statements. These statements can be identified by the use of words such as 'believes,' 'anticipates,' 'expects,' 'intends,' 'plans,' 'continues,' 'estimates,' 'predicts,' 'projects,' 'forecasts,' 'may,' 'could,' and similar expressions. All forward-looking statements are based on current expectations and beliefs as of the date of this release and are subject to risks, uncertainties and other factors that may cause actual results to differ materially from the expectations discussed in, or implied by, the forward-looking statements. Many of these factors are beyond our ability to control or predict including, without limitation, reductions in payments from government health care programs and private insurance payors, such as health maintenance organizations, preferred provider organizations, and other managed care organizations and employers; our ability to contract with private insurance payors; changes in our payor mix or surgical case mix; failure to maintain or develop relationships with physicians on beneficial or favorable terms, or at all; the impact of payor controls designed to reduce the number of surgical procedures; our efforts to integrate operations of acquired or developed businesses and surgical facilities, attract new physician partners, or acquire additional surgical facilities; supply chain issues, including shortages or quality control issues with surgery-related products, equipment and medical supplies; competition for physicians, nurses, strategic relationships, acquisitions and managed care contracts; our ability to attract and retain qualified health care professionals; our ability to enforce non-compete restrictions against our physicians; our ability to manage material liabilities whether known or unknown incurred as a result of acquiring or operating surgical facilities; the impact of future legislation and other health care regulatory reform actions, and the effect of that legislation and other regulatory actions on our business; our ability to comply with current health care laws and regulations; the outcome of legal and regulatory proceedings that have been or may be brought against us; the impact of cybersecurity attacks or intrusions, changes in the regulatory, economic and other conditions of the states where our surgical facilities are located; our indebtedness; the social and economic impact of a pandemic, epidemic or outbreak of a contagious disease on our business; and the risks and uncertainties identified and discussed from time to time in the Company’s reports filed with the SEC, including in Item 1A under the heading 'Risk Factors' in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and other reports filed with the SEC. Except as required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements to reflect events or circumstances after the date of this report, or to reflect the occurrence of unanticipated events or circumstances. Use of Non-GAAP Financial Measures In addition to the results prepared in accordance with generally accepted accounting principles in the United States ('GAAP') provided throughout this press release, Surgery Partners has presented the following non-GAAP financial measures: Adjusted net income (loss) attributable to common stockholders, Adjusted net income (loss) per share attributable to common stockholders, Adjusted EBITDA, and Adjusted EBITDA related to unconsolidated affiliates, which exclude various items detailed in the 'Reconciliation of Non-GAAP Financial Measures' below. These non-GAAP financial measures are not intended to replace financial performance measures determined in accordance with GAAP. Rather, they are presented as supplemental measures of the Company's performance that management believes may enhance the evaluation of the Company's ongoing operating results. These non-GAAP financial measures are not presented in accordance with GAAP, and the Company’s computation of these non-GAAP financial measures may vary from similar measures used by other companies. These measures have limitations as an analytical tool and should not be considered in isolation or as a substitute or alternative to revenue, net income or loss, operating income or loss, cash flows from operating activities, total indebtedness or any other measures of operating performance, liquidity or indebtedness derived in accordance with GAAP. SURGERY PARTNERS, INC. Selected Consolidated Financial Data(Dollars in millions, except per share amounts, shares in thousands)(Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Revenues $826.2 $762.1 $1,602.2 $1,479.5 Operating expenses: Salaries and benefits 235.2 223.2 473.8 438.4 Supplies 215.0 199.7 430.8 388.5 Professional and medical fees 102.1 92.4 197.4 175.0 Lease expense 22.9 22.2 43.7 43.6 Other operating expenses 55.4 45.4 99.0 99.5 Cost of revenues 630.6 582.9 1,244.7 1,145.0 General and administrative expenses 36.1 40.3 72.1 73.5 Depreciation and amortization 40.3 34.8 76.6 68.5 Transaction and integration costs 18.1 19.3 42.8 36.7 Net (gain) loss on disposals, consolidations and deconsolidations (3.0) 5.3 3.4 6.8 Equity in earnings of unconsolidated affiliates (5.5) (4.4) (11.1) (7.1)Litigation settlement - 0.5 2.2 (1.3)Loss on debt extinguishment - 5.1 - 5.1 Other income, net (2.1) (6.5) (2.1) (8.5) 714.5 677.3 1,428.6 1,318.7 Operating income 111.7 84.8 173.6 160.8 Interest expense, net (67.9) (51.5) (130.1) (98.8)Income before income taxes 43.8 33.3 43.5 62.0 Income tax benefit (expense) 1.1 (4.9) 1.1 (9.3)Net income 44.9 28.4 44.6 52.7 Less: Net income attributable to non-controlling interests (47.4) (43.9) (84.8) (80.6)Net loss attributable to Surgery Partners, Inc. $(2.5) $(15.5) $(40.2) $(27.9) Net loss per share attributable to common stockholders Basic $(0.02) $(0.12) $(0.32) $(0.22)Diluted(1) $(0.02) $(0.12) $(0.32) $(0.22",
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"description": "Raises mid-point of 2025 Net Sales and Adj. EBITDA guidanceBoard approves $100 million Share Repurchase Program CINCINNATI, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Hillman Solutions Corp. (Nasdaq: HLMN) (the 'Company” or 'Hillman”), a leading provider of hardware products and merchandising solutions, reported financial results for the thirteen and twenty-six weeks ended June 28, 2025. Second Quarter 2025 Highlights (Thirteen weeks ended June 28, 2025)Net sales increased 6.2% to $402.8 million compared to $379.4 million in the prior year quarterNet income totaled $15.8 million, or $0.08 per diluted share, compared to $12.5 million, or $0.06 per diluted share, in the prior year quarterAdjusted diluted EPS1 totaled $0.17 per diluted share compared to $0.16 per diluted share in the prior year quarterAdjusted EBITDA1 increased to $75.2 million compared to $68.4 million in the prior year quarterNet cash provided by operating activities was $48.7 million compared to $64.8 million in the prior year quarterFree Cash Flow1 totaled $31.2 million compared to $42.5 million in the prior year quarterSubsequent to quarter-end, Hillman's Board of Directors authorized a new $100 million share repurchase program Balance Sheet and Liquidity at June 28, 2025Gross debt was $708.9 million compared to $718.6 million on December 28, 2024Net debt1 was $674.7 million compared to $674.0 million on December 28, 2024Liquidity available totaled $246.9 million; consisting of $212.7 million of available borrowing under the revolving credit facility and $34.2 million of cash and equivalentsNet debt1 to trailing twelve month Adjusted EBITDA improved to 2.7x at quarter end compared to 2.8x on December 28, 2024Management Commentary 'Our team has done a fantastic job successfully managing the tariff environment while continuing to provide great customer service at the shelf and delivering orders on-time and in-full,' commented Jon Michael Adinolfi, President and CEO of Hillman. 'During the quarter, we delivered robust top and bottom-line results which produced strong free cash flow and reduced our net debt outstanding. Looking forward, we are confident that the resilience of our business together with our long-term growth opportunities will drive growth for the remainder of 2025 and for years to come.' Full Year 2025 Guidance - Updated Based on year-to-date performance and its expectations for the remainder of the year, management is updating its guidance most recently provided on April 29, 2025 with Hillman's first quarter 2025 results. Previous FY 2025 GuidanceUpdated FY 2025 GuidanceNet Sales$1.495 to $1.575 billion$1.535 to $1.575 billionAdjusted EBITDA1$255 to $275 million$265 to $275 millionYear-end leverage2.5x leverage at year end2.4x leverage at year end Rocky Kraft, Hillman's chief financial officer added: 'Strong execution during the first half of the year, some clarity around tariffs, and a better outlook for the second half of the year have resulted in us raising the low-end of our guidance for both Net Sales and Adjusted EBITDA, therefore raising the midpoint of both. We now believe we will end the year with a leverage ratio of around 2.4 times, even with a modest share repurchase.' 1) Denotes Non-GAAP metric. For additional information, including our definitions, use of, and reconciliations of these metrics to the most directly comparable financial measures under GAAP, please see the reconciliations toward the end of the press release. Share Repurchase Program Hillman's Board of Directors authorized a share repurchase program ('SRP') for up to $100 million of the currently outstanding shares of the Company's common stock. The SRP permits shares of common stock to be repurchased from time to time at management's discretion, through a variety of methods, including a 10b5-1 trading plan, open market purchases, privately negotiated transactions or transactions otherwise in compliance with Rule 10b-18 under the Securities Exchange Act of 1934, as amended. Second Quarter 2025 Results Presentation Hillman plans to host a conference call and webcast presentation today, August 5, 2025, at 8:30 a.m. Eastern Time to discuss its results. President and Chief Executive Officer Jon Michael Adinolfi and Chief Financial Officer Rocky Kraft will host the results presentation. Date: Tuesday, August 5, 2025 Time: 8:30 a.m. Eastern Time Listen-Only Webcast:https://edge.media-server.com/mmc/p/jok22dbq A webcast replay will be available approximately one hour after the conclusion of the call using the link above. Hillman’s quarterly presentation and Form 10-Q are expected to be filed with the SEC and posted to its Investor Relations website, https://ir.hillmangroup.com, prior to the webcast presentation. About Hillman Solutions Corp. Hillman Solutions Corp. ('Hillman”) is a leading provider of hardware-related products and solutions to home improvement, hardware, and farm and fleet retailers across North America. Renowned for its commitment to customer service, Hillman has differentiated itself with its competitive moat built on direct-to-store shipping, a dedicated in-store sales and service team of over 1,200 professionals, and over 60 years of product and industry experience. Hillman’s extensive portfolio includes hardware solutions (fasteners, screws, nuts and bolts), protective solutions (work gloves, jobsite storage and protective gear), and robotic and digital solutions (key duplication and tag engraving). Leveraging its world-class distribution network, Hillman regularly earns vendor of the year recognition from top customers. For more information on Hillman, visit www.hillman.com. Forward-Looking Statements All statements made in this press release that are considered to be forward-looking are made in good faith by the Company and are intended to qualify for the safe harbor from liability established by Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995. You should not rely on these forward-looking statements as predictions of future events. Words such as 'expect,' 'estimate,' 'project,' 'budget,' 'forecast,' 'anticipate,' 'intend,' 'plan,' 'target”, 'goal”, 'may,' 'will,' 'could,' 'should,' 'believes,' 'predicts,' 'potential,' 'continue,' and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to future performance. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside the Company's control and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) unfavorable economic conditions that may affect our and our customers’, suppliers’ and other business partners’ operations, financial condition and cash flows including spending on home renovation or construction projects, inflation, recessions, instability in the financial markets or credit markets; (2) increased supply chain costs, including tariffs, raw materials, sourcing, transportation and energy; (3) the highly competitive nature of the markets that we serve; (4) the ability to continue to innovate with new products and services; (5) seasonality; (6) large customer concentration; (7) the ability to recruit and retain qualified employees; (8) the outcome of any legal proceedings that may be instituted against the Company; (9) adverse changes in currency exchange rates; or (10) regulatory changes and potential legislation that could adversely impact financial results. The foregoing list of factors is not exclusive, and readers should also refer to those risks that are included in the Company’s filings with the Securities and Exchange Commission ('SEC”), including the Annual Report on Form 10-K filed on February 20, 2025. Given these uncertainties, current or prospective investors are cautioned not to place undue reliance on any such forward-looking statements. Except as required by applicable law, the Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements in this communication to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. Contact: Michael Koehler Vice President of Investor Relations & Treasury 513-826-5495 IR@hillmangroup.comHILLMAN SOLUTIONS CORP. Condensed Consolidated Statement of Net Loss, GAAP Basis (dollars in thousands) Unaudited Thirteen Weeks EndedJune 28, 2025 Thirteen Weeks EndedJune 29, 2024 Twenty-six Weeks Ended June 28, 2025 Twenty-six Weeks EndedJune 29, 2024Net sales$402,803 $379,432 $762,146 $729,737 Cost of sales (exclusive of depreciation and amortization shown separately below) 208,338 194,672 399,078 378,106 Selling, warehouse, general and administrative expenses 123,707 121,154 242,759 239,719 Depreciation 19,848 16,297 39,243 32,635 Amortization 15,257 15,249 30,672 30,503 Other (income) expense (664) 474 (938) 884 Income from operations 36,317 31,586 51,332 47,890 Interest expense, net 13,892 13,937 28,352 29,208 Refinancing costs - - 906 3,008 Income before income taxes 22,425 17,649 22,074 15,674 Income tax expense 6,593 5,114 6,559 4,631 Net income$15,832 $12,535 $15,515 $11,043 Basic income per share$0.08 $0.06 $0.08 $0.06 Weighted average basic shares outstanding 197,593 196,075 197,439 195,721 Diluted income per share$0.08 $0.06 $0.08 $0.06 Weighted average diluted shares outstanding 198,676 198,420 199,257 198,037 HILLMAN SOLUTIONS CORP. Condensed Consolidated Balance Sheets (dollars in thousands) Unaudited June 28, 2025 December 28, 2024ASSETS Current assets: Cash and cash equivalents$34,188 $44,510 Accounts receivable, net of allowances of $1,644 ($2,827 - 2024) 141,178 109,788 Inventories, net 427,633 403,673 Other current assets 20,545 15,213 Total current assets 623,544 573,184 Property and equipment, net of accumulated depreciation of $406,602 ($376,150 - 2024) 234,852 224,174 Goodwill 830,535 828,553 Other intangibles, net of accumulated amortization of $562,043 ($530,398 - 2024) 576,459 605,859 Operating lease right of use assets 74,088 81,708 Other assets 17,152 17,025 Total assets$2,356,630 $2,330,503 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$169,483 $139,057 Current portion of debt and financing lease liabilities 13,912 12,975 Current portion of operating lease liabilities 17,426 16,850 Accrued expenses: Salaries and wages 24,452 34,977 Pricing allowances 6,374 7,651 Income and other taxes 10,536 10,377 Other accrued liabilities 31,068 31,843 Total current liabilities 273,251 253,730 Long-term debt 683,082",
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"title": "Xometry Reports Record Second Quarter 2025 Results",
"description": "Q2 revenue increased 23% year-over-year to a record $163 million driven by robust marketplace growth.Q2 marketplace revenue increased 26% year-over-year driven by strong enterprise growth and expanding networks of buyers and suppliers.Q2 gross profit increased 23% year-over-year to a record $65.2 million, or 40.1% of revenue driven by record marketplace gross margin of 35.4%.Q2 Adjusted EBITDA improved $6.6 million year-over-year to Adjusted EBITDA of $3.9 million driven by expanding marketplace gross margin and strong operating expense leverage.Strong operating results are driven by consistent execution across growth initiatives: expanding buyer and supplier networks; driving deeper enterprise engagement; further expanding the marketplace platform; growing internationally and enhancing supplier services. NORTH BETHESDA, Md., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Xometry, Inc. (NASDAQ: XMTR), the global AI-powered marketplace connecting buyers with suppliers of manufacturing services, today announced financial results for the second quarter ended June 30, 2025. 'We delivered strong performance across the board this quarter,” said Randy Altschuler, CEO at Xometry. 'The record results reflect investments we’ve made in platform innovation, enterprise initiatives and network expansion - key drivers that position Xometry for sustainable, long-term growth. We expect continued growth momentum as we gain share in our large fragmented market.” 'In Q2, we generated record revenue, significant marketplace gross margin expansion and strong operating leverage. Our Adjusted EBITDA improved by $6.6 million year-over-year to $3.9 million,” said James Miln, CFO at Xometry. 'As we scale to $1 billion of revenue, we expect to deliver improving profitability even as we continue to invest in our growth initiatives.” Second Quarter 2025 Financial HighlightsMarketplace revenue for the second quarter of 2025 was $148 million, an increase of 26% year-over-year.Marketplace Active Buyers increased 22% from 61,530 as of June 30, 2024 to 74,777 as of June 30, 2025.Marketplace Accounts with Last Twelve-Months Spend of at least $50,000 increased 15% from 1,436 as of June 30, 2024 to 1,653 as of June 30, 2025.Supplier services revenue for the second quarter of 2025 was $14.3 million, a decrease of 6% year-over-year.Net loss attributable to common stockholders for the second quarter of 2025 was $26.4 million. This includes a $16.4 million non-recurring loss on debt extinguishment.Adjusted EBITDA for the second quarter of 2025 was a profit of $3.9 million, reflecting an improvement of $6.6 million year-over-year.Non-GAAP net income for the second quarter of 2025 was $4.7 million, as compared to a Non-GAAP net loss of $0.6 million in the second quarter of 2024. Cash, cash equivalents and marketable securities were $226 million as of June 30, 2025. Business highlights since Xometry's last earnings announcement include: Completed convertible debt refinancing and closing of $250 million of new 0.75% convertible notes due 2030.The transaction addressed over $200 million principal amount that had 2027 maturities, providing financial flexibility to focus on our growth initiatives and margin expansion. Purchased a capped call hedge with a cap price initially at $63.35, which represents a 75% premium over the market price on the transaction date.Xometry EU launched Teamspace in Europe, the UK and Turkey. Teamspace is a cloud-based solution within the Xometry platform that enables customers to collaborate with their colleagues on projects and custom part orders. This global expansion enables Xometry to drive deeper enterprise engagement and enhance viral buyer growth within a company.Xometry EU launched integration capabilities for enterprise customers to streamline procurement. This feature enables buyers to order custom parts directly from the Xometry site while still within the buyer's procurement platform - streamlining the purchasing process, reducing errors, and improving efficiency by automating data transfer between systems.In North America Xometry introduced a new AI feature on the marketplace to accelerate our initiative to instantly quote technical drawings. This feature automates the extraction of information from technical drawings to help drive more accurate quoting and supplier selection.Thomasnet announced its partnership with NSF, a recognized global leader in public health and safety certification, to become the preferred certification body for its digital industrial sourcing platform. Suppliers listed on Thomasnet will have the opportunity to earn certifications, including management system certifications, from NSF’s wide-ranging portfolio of services. NSF will also promote Thomasnet as a platform for manufacturing businesses to reach new audiences. Financial Summary(In thousands, except per share amounts)(Unaudited) For the Three MonthsEnded June 30, For the Six MonthsEnded June 30, 2025 2024 % Change 2025 2024 % Change Consolidated Revenue $162,547 $132,595 23% $313,518 $255,285 23%Gross profit 65,176 52,877 23% 121,507 100,779 21%Net loss attributable to common stockholders (26,434) (13,697) (93)% (41,512) (30,313) (37)%EPS, basic and diluted, of Class A and Class B common stock (0.52) (0.28) (86)% (0.82) (0.62) (32)%Adjusted EBITDA(1) 3,926 (2,634) 249% 4,004 (10,093) 140%Non-GAAP net income (loss)(1) 4,681 (606) 872% 5,509 (6,348) 187%Non-GAAP EPS, basic(1), of Class A and Class B common stock 0.09 (0.01) 1000% 0.11 (0.13) 185%Non-GAAP EPS, diluted(1), of Class A and Class B common stock 0.09 (0.01) 1000% 0.10 (0.13) 177% Marketplace Revenue $148,223 $117,287 26% $284,576 $224,473 27%Cost of revenue 95,759 78,024 23% 188,805 150,931 25%Gross Profit $52,464 $39,263 34% $95,771 $73,542 30%Gross Margin 35.4% 33.5% 1.9% 33.7% 32.8% 0.9% Supplier services Revenue $14,324 $15,308 (6)% $28,942 $30,812 (6)%Cost of revenue 1,612 1,694 (5)% 3,206 3,575 (10)%Gross Profit $12,712 $13,614 (7)% $25,736 $27,237 (6)%Gross Margin 88.7% 88.9% (0.2)% 88.9% 88.4% 0.5% (1) These non-GAAP financial measures, and the reasons why we believe these non-GAAP financial measures are useful, are described below and reconciled to their most directly comparable GAAP measures in the accompanying tables. Key Operating Metrics(2): As of June 30, 2025 2024 % Change Active Buyers(3) 74,777 61,530 22%Percentage of Revenue from Existing Accounts(3) 98% 96% Accounts with Last Twelve-Months Spend of at Least $50,000(3) 1,653 1,436 15% (2) These key operating metrics are for Marketplace and Supplier Services. See 'Key Terms for our Key Metrics and Non-GAAP Financial Measures” below for definitions of these metrics.(3) Amounts shown for Active Buyers, Accounts with Last Twelve-Months Spend of at Least $50,000 and Percentage of Revenue from Existing Accounts is presented for the quarters ended June 30, 2025 and 2024. Financial Guidance and Outlook: Q3 2025 (in millions) Low High Revenue $167 $169 Adjusted EBITDA $4.0 $5.0 For Q3 2025, expect revenue of $167-$169 million, representing 18-19% growth year-over-year.For Q3 2025, expect Adjusted EBITDA of approximately $4.0-5.0 million, an improvement from an Adjusted EBITDA loss of $0.6 million in Q3 2024.For the full year 2025, we are raising our marketplace growth outlook from our previous guidance of at least 22% growth to 23-24% growth.We expect supplier services revenue to be down approximately 5% year-over-year.For FY 2025, expect incremental Adjusted EBITDA margin of approximately 21% on a year-over-year basis. Xometry’s third quarter 2025 and full year 2025 financial outlook is based on a number of assumptions that are subject to change and many of which are outside of its control. If actual results vary from these assumptions, Xometry’s expectations may change. There can be no assurance that Xometry will achieve these results. Reconciliation of Adjusted EBITDA on a forward-looking basis to net loss, the most directly comparable GAAP measure, is not available without unreasonable efforts due to the high variability and complexity and low visibility with respect to certain charges excluded from this non-GAAP measure, including interest and dividend income, benefit for income taxes, charitable contributions of common stock and impairment of assets. Xometry expects the variability of these items could have a significant, and potentially unpredictable, impact on its future GAAP financial results. Use of Non-GAAP Financial Measures To supplement its consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States of America ('GAAP”), Xometry, Inc. ('Xometry”, the 'Company”, 'we” or 'our”) uses Adjusted EBITDA, non-GAAP net income (loss) and non-GAAP Earnings Per Share basic and diluted, which are considered non-GAAP financial measures, as described below. These non-GAAP financial measures are presented to enhance the user’s overall understanding of Xometry’s financial performance and should not be considered a substitute for, nor superior to, the financial information prepared and presented in accordance with GAAP. The non-GAAP financial measures presented in this release, together with the GAAP financial results, are the primary measures used by the Company’s management and board of directors to understand and evaluate the Company’s financial performance and operating trends, including period-to-period comparisons, because they exclude certain expenses and gains that management believes are not indicative of the Company’s core operating results. Management also uses these measures to prepare and update the Company’s short and long term financial and operational plans, to evaluate investment decisions, and in its discussions with investors, commercial bankers, equity research analysts and other users of the Company’s financial statements. Accordingly, the Company believes that these non-GAAP financial measures provide useful information to investors and others in understanding and evaluating the Company’s operating results in the same manner as the Company’s management and in comparing operating results across periods and to those of Xometry’s peer companies. In addition, from time to time we may present adjusted information (for example, revenue growth) to exclude the impact of certain gains, losses or other changes that affect period-to-period comparability of our operating performance. The use of non-GAAP financial measures has certain limitations because they do not reflect all items of income and expense, or cash flows, that affect the Company’s financial performance and operations. Additionally, non-GAAP financial measures do not have standardized meanings, and therefore other companies, including peer companies, may use the same or similarly named measures but exclude or include different items or use different computations. Management compensates for these limitations by reconciling these non-GAAP financial measures to their most comparable GAAP financial measures in the tables captioned 'Reconciliations of Non-GAAP Financial Measures” included at the end of this release. Investors and others are encouraged to review the Company’s financial information in its entirety and not rely on a single financial measure. Key Terms for our Key Metrics and Non-GAAP Financial MeasuresMarketplace revenue: includes the sale of parts and assemblies on our platform. Supplier service revenue: includes the sales of marketing and advertising services and, to a lesser extent, financial service products and SaaS-based solutions. Active Buyers: The Company defines 'buyers” as individuals who have placed an order to purchase on-demand parts or assemblies on our marketplace. The Company defines Active Buyers as the number of buyers who have made at least one purchase on our marketplace during the last twelve months. Active Suppliers: The Company defines 'suppliers” as individuals or businesses that have been approved by us to either manufacture a product on our platform for a buyer or have utilized our supplier services, including our digital marketing services, data services, financial services or tools and materials. The Company defines Active Suppliers as suppliers that have used our platform at least once during the last twelve months to manufacture a product. Percentage of Revenue from Existing Accounts: The Company defines an 'account” as an individual entity, such as a sole proprietor with a single buyer or corporate entities with multiple buyers, having purchased at least one part on our marketplace. The Company defines an existing account as an account where at least one buyer has made a purchase on our marketplace. Accounts with Last Twelve-Month Spend of At Least $50,000: The Company defines Accounts with Last Twelve-Month Spend of At Least $50,000 as an account that has spent at least $50,000 on our marketplace in the most recent twelve-month period. Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA): The Company defines Adjusted EBITDA as net loss, adjusted for interest expense, interest and dividend income and other expenses, and certain other non-cash or non-recurring items impacting net loss from time to time, principally comprised of depreciation and amortization, amortization of lease intangible, benefit for income taxes, stock-based compensation, payroll tax expense related to stock-based compensation, charitable contributions of common stock, income from unconsolidated joint venture, restructuring charges and acquisition and other adjustments not reflective of the Company’s ongoing business, such as adjustments related to purchase accounting, the revaluation of contingent consideration, transaction costs and executive severance. Non-GAAP net income (loss): The Company defines non-GAAP net income (loss) as net loss adjusted for depreciation and amortization, stock-based compensation, payroll tax expense related to stock-based compensation, amortization of lease intangible, amortization of deferred costs on convertible notes, gain on sale of property and equipment, charitable contributions of common stock, lease termination, restructuring charges, loss on debt extinguishment and acquisition and other adjustments not reflective of the Company’s ongoing business, such as adjustments related to purchase accounting, the revaluation of contingent consideration, transaction costs and executive severance. Non-GAAP Earnings Per Share, basic and diluted (Non-GAAP EPS, basic and diluted): The Company calculates non-GAAP earnings per share, basic and diluted as non-GAAP net income (loss) divided by weighted avera",
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"description": "Medical revenue increased 17.6% year-over-year in Q2 2025 Net loss improved by $7.6 million versus the prior year to $(3.7) million in Q2 2025; Adjusted EBITDA improved by $2.2 million versus the prior year to $3.2 million in Q2 2025(1)Blade Passenger division to be sold to Joby Aviation for up to $125 million; Blade’s Medical division will remain a standalone public company, rebrand as Strata Critical Medical ('Strata')Sale is expected to be Adjusted EBITDA and Free Cash Flow neutral on a go forward basis NEW YORK, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Blade Air Mobility, Inc. (Nasdaq: BLDE, 'Blade' or the 'Company'), today announced financial results for the second quarter ended June 30, 2025. GAAP FINANCIAL RESULTS(in thousands except percentages, unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 % Change 2025 2024 % ChangeRevenue$70,801 $67,945 4.2 % $125,107 $119,459 4.7 %Cost of revenue$53,064 $51,591 2.9 % $95,392 $92,966 2.6 %Software development 915 971 (5.8)% 1,727 1,641 5.2 %General and administrative 20,142 25,136 (19.9)% 37,456 42,345 (11.5)%Selling and marketing 1,634 2,396 (31.8)% 3,069 4,524 (32.2)%Total operating expenses$75,755 $80,094 (5.4)% $137,644 $141,476 (2.7)%Loss from operations$(4,954) $(12,149) (59.2)% $(12,537) $(22,017) (43.1)%Net loss$(3,743) $(11,326) (67.0)% $(7,236) $(15,560) (53.5)% Gross profit$12,889 $11,336 13.7 % $20,982 $17,188 22.1 %Gross margin 18.2% 16.7% 150bps 16.8% 14.4% 240bps NON-GAAP(1) FINANCIAL RESULTS(in thousands except percentages, unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 % Change 2025 2024 % ChangeRevenue$70,801 $67,945 4.2 % $125,107 $119,459 4.7 %Cost of revenue 53,064 51,591 2.9 % 95,392 92,966 2.6 %Flight Profit 17,737 16,354 8.5 % 29,715 26,493 12.2 %Flight Margin 25.1% 24.1% 100bps 23.8% 22.2 % 160bpsAdjusted SG&A 15,399 15,834 (2.7)% 29,370 29,602 (0.8)%Depreciation included in cost of revenue 852 438 NM(2) 1,607 521 NM(2)Adjusted EBITDA$3,190 $958 233.0% $1,952 $(2,588) NM(2)Adjusted EBITDA as a percentage of Revenue 4.5% 1.4% 310bps 1.6% (2.2)% NM(2)Passenger Adjusted EBITDA$2,389 $782 205.5 % $2,443 $(1,869) NM(2)Medical Adjusted EBITDA$6,039 $5,524 9.3 % $10,137 $9,933 2.1 %Adjusted unallocated corporate expenses and software",
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"description": "Raises Full Year Revenue Guidance to at Least 17% Growth or $219 Million ALACHUA, Fla. and TAMPA, Fla., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for the restoration of peripheral nerve function, today reported financial results and business highlights for the second quarter ended June 30, 2025. Second Quarter Financial ResultsSecond quarter revenue was $56.7 million, an 18.3% increase compared to the second quarter of 2024, and a 16.7% increase over the first quarter of 2025.For the second quarter of 2025, gross margin was 74.2%, up from 73.8% for the second quarter of 2024, and up from 71.9% in the first quarter of 2025.Net income for the quarter was $0.6 million, or $0.01 per share, compared to a Net loss of $1.9 million, or $0.04 per share for the second quarter of 2024.Adjusted net income for the quarter was $5.7 million, or $0.12 per share, compared to $2.0 million, or $0.05 per share, for the second quarter of 2024.Adjusted EBITDA was $9.3 million for the quarter, compared to $5.6 million for the second quarter of 2024.The balance of cash and cash equivalents, restricted cash, and investments at June 30, 2025, was $35.9 million, as compared to a balance of $39.5 million at December 31, 2024. Cash and cash equivalents, restricted cash, and investments increased $7.8 million during the second quarter of 2025. 'We are delighted with our second quarter 2025 results and progress year to date implementing our strategic plan. Our strong revenue growth across the full range of our nerve repair solutions reflects the soundness of our market development strategies and strength and discipline of our commercial execution,” commented Michael Dale, CEO and Director of Axogen, Inc. 'With the first half of the year behind us, we remain confident our market development objectives and business model optimization plans are the right priorities for advancing our business purpose to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care.” Summary of Business HighlightsSecond quarter 2025 revenue growth was broad-based, including double-digit growth from second quarter 2024 in all markets, which includes Extremities, Oral Maxillofacial & Head and Neck, and Breast.Expanded coverage and reimbursement for nerve repair for peripheral nerve injuries using synthetic conduits or allografts by an estimated 10 million new covered lives in 2025; bringing the total new lives covered in 2025 to approximately 17 million, which brings coverage amongst commercial payers to more than 55%.The U.S. Food and Drug Administration ('FDA”) accepted the filing of the Company’s Biologics License Application ('BLA”) for Avance® Nerve Graft on November 1, 2024, and assigned a Prescription Drug User Fee Act goal date of September 5, 2025. During the second quarter 2025, we completed the following regulatory milestones to support our anticipated approval in September 2025: the late-cycle meeting with the FDA, pre-licensing inspection, and sponsor inspection under the FDA’s Bioresearch Monitoring program.2025 Financial Guidance We are raising our revenue guidance to at least 17% growth, or $219 million for the full year. We continue to expect gross margin for the year to be in the range of 73% to 75%. This range reflects one-time costs, mainly related to an anticipated Avance® Nerve Graft BLA approval, which we expect will negatively impact gross margin by approximately 1%. Lastly, we reiterate that we expect to be net cash flow positive for the full year. Conference Call The Company will host a conference call and webcast for the investment community today at 8:00 a.m. ET. Investors interested in participating in the conference call by phone may do so by dialing toll free at (877) 407-0993 or use the direct dial-in number at (201) 689-8795. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors page of the Company’s website at www.axogeninc.com and clicking on the webcast link. Following the conference call, a replay will be available in the Investors section of the Company’s website at www.axogeninc.com under Investors. About Axogen Axogen (AXGN) is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about providing the opportunity to restore nerve function and quality of life for patients with peripheral nerve injuries by providing innovative, clinically proven and economically effective repair solutions for surgeons and healthcare providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve or the inability to properly reconnect peripheral nerves can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain. Axogen’s product portfolio includes Avance® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site; Axoguard Nerve Connector®, a porcine (pig) submucosa extracellular matrix ('ECM”) coaptation aid for tensionless repair of severed peripheral nerves; Axoguard Nerve Protector®, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while minimizing soft tissue attachments; Axoguard HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; Axoguard Nerve Cap®, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma; and Avive+ Soft Tissue Matrix™, a multi-layer amniotic membrane allograft used to protect and separate tissues in the surgical bed during the critical phase of tissue healing. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea and several other countries. For more information, visit www.axogeninc.com. Cautionary Statements Concerning Forward-Looking Statements This press release contains 'forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations or predictions of future conditions, events, or results based on various assumptions and management’s estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as 'expects,” 'anticipates,” 'priorities,” 'objectives,” 'targets,” 'intends,” 'plan(s),” 'believes,” 'seeks,” 'estimates,” 'projects,” 'forecasts,” 'continue,” 'may,” 'should,” 'will,” 'goals,” and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding our business model optimization plans, market development strategies and objectives, our beliefs around the strengths and discipline of our commercial execution, our business purpose to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care, and our expectation of BLA approval in September 2025, as well as statements under the subheading '2025 Financial Guidance.” Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, potential disruptions from leadership transitions, global supply chain issues, record inflation, hospital staffing challenges, product development timelines, product potential, expected clinical enrollment timing and outcomes, regulatory processes and approvals, financial performance, sales growth, surgeon and product adoption rates, market awareness of our products, data validation processes, our visibility at and sponsorship of conferences and educational events, global business disruption from Russia’s invasion of Ukraine and related sanctions, recent geopolitical conflicts in the Middle East, the evolving macroeconomic environment (including financial market volatility), escalating geopolitical tensions and trade disputes with U.S. trading partners, as well as those risk factors described under Part I, Item 1A., 'Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2024 and other risks and uncertainties, which may be detailed from time to time in reports filed by the Company with the SEC. Forward-looking statements are not a guarantee of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements. About Non-GAAP Financial Measures To supplement our condensed consolidated financial statements, we use the non-GAAP financial measures of EBITDA, which measures earnings before interest, income taxes, depreciation and amortization, and Adjusted EBITDA which further excludes noncash stock compensation expense. We also use the non-GAAP financial measures of Adjusted Net Income or Loss and Adjusted Net Income or Loss Per Common Share - diluted which excludes noncash stock compensation expense from Net Income or Loss and Net Income or Loss Per Common Share - diluted. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures should be read in conjunction with our financial statements prepared in accordance with GAAP. The reconciliations of the non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP should be carefully evaluated. We use these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. We believe that these non-GAAP financial measures provide meaningful supplemental information regarding our performance and that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP financial measures are useful to investors because (i) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (ii) they are used by our institutional investors and the analyst community to help them analyze the performance of our business. Contact: Axogen, Inc. InvestorRelations@axogeninc.com Axogen, Inc.Condensed Consolidated Balance Sheets(unaudited)(In thousands, except share and per share amounts) June 30,2025 December 31,2024Assets Current assets: Cash and cash equivalents$ 20,036 $ 27,554 Restricted cash 6,000 6,000 Investments 9,886 5,928 Accounts receivable, net of allowance for doubtful accounts of $1,144 and $788, respectively 28,029 24,105 Inventory 36,774 33,183 Prepaid expenses and other assets 2,694 2,447 Total current assets 103,419 99,217 Property and equipment, net 82,392 84,667 Operating lease right-of-use assets 13,527 14,265 Intangible assets, net 6,115 5,579 Total assets$ 205,453 $ 203,728 Liabilities and shareholders’ equity Current liabilities: Accounts payable and accrued expenses$ 22,770 $ 28,641 Current maturities of long-term lease obligations 2,210 1,969 Total current liabilities 24,980 30,610 Long-term debt, net of debt discount and financing fees 47,938 47,496 Long-term lease obligations 18,040 19,221 Debt derivative liabilities 2,078 2,400 Other long-term liabilities 141 94 Total liabilities 93,177 99,821 Shareholders’ equity: Common stock, $0.01 par value per share; 100,000,000 shares authorized; 45,765,290 and 44,148,836 shares issued and outstanding, respectively 457 441 Additional paid-in capital 406,334 394,726 Accumulated deficit (294,515) (291,260)Total shareholders’ equity 112,276 103,907 Total liabilities and shareholders’ equity$ 205,453 $ 203,728 Axogen, Inc.Condensed Consolidated Statements of Operations(unaudited)(In thousands, except share and per share amounts) Three Months Ended Six Months Ended June 30, 2025 June 30, 2024 June 30, 2025 June 30, 2024Revenues$ 56,662 $ 47,912 $ 105,222 $ 89,289 Cost of goods sold 14,644 12,567 28,271 21,325 Gross profit 42,018 35,345 76,951 67,964 Costs and expenses: Sales and marketing 23,804 19,698 44,849 39,513 Research and development 6,853 6,658 12,944 14,066 General and administrative 9,689 9,417 19,147 19,373 Total costs and expenses 40,346 35,773 76,940 72,952 Income (loss) from operations 1,672 (428) 11 (4,988)Other income (expense): Investment income 225 227 497 520 Interest expense (1,977) (2,185) (4,227) (4,512)Change in fair value of debt derivative liabilities 480 464 322 529 Other income (expense), net 179 1 142 (105",
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"description": "Delivers first quarter of positive GAAP EPS in Company’s history since going public, announces initial results from AI InitiativeSOMERSET, N.J., Aug. 05, 2025 (GLOBE NEWSWIRE) -- CareCloud, Inc. (Nasdaq: CCLD, CCLDO) ('CareCloud” or the 'Company”), a leader in healthcare technology and generative AI solutions, today announced strong financial results for the quarter ended June 30, 2025. CareCloud’s strategic execution, AI-driven innovation, and disciplined financial management has positioned the Company for sustained profitability and long-term growth. Management will discuss these results and the Company’s 2025 growth strategies in a live conference call today at 8:30 a.m. ET. Second Quarter 2025 Highlights ●GAAP net income of $2.9 million, compared to $1.7 million in Q2 2024, an increase of 73% ●Positive GAAP EPS of $0.04 per share, compared to negative GAAP EPS of ($0.14) per share in Q2 of 2024 ●Adjusted net income of $3.3 million, or $0.07 per share, compared to $3.0 million in Q2 2024 ●Adjusted EBITDA of $6.5 million, compared to $6.4 million in Q2 2024 ●Revenue of $27.4 million, compared to $28.1 million in Q2 2024 Year-to-date 2025 Highlights ●GAAP net income of $4.9 million, compared to $1.4 million in the same period last year, an increase of 238% ●Positive GAAP EPS of $0.02 per share, compared to a negative GAAP EPS of ($0.24) per share in the same period last year ●Adjusted net income of $5.6 million, or $0.13 per share, compared to $3.2 million in the same period last year ●Adjusted EBITDA of $12.1 million, compared to $10.1 million in the same period last year, an increase of 20% ●Free cash flow of $9.0 million, compared to $4.9 million in the same period last year, an increase of 85% ●Revenue of $55.0 million, compared to $54.1 million in the same period last year Recent Strategic Updates ●Financial Achievement: First quarter of positive GAAP EPS in CareCloud’s history since going public in 2014 ●AI Center of Excellence: Now live and scaling to 500 team members by year-end, with dedicated teams driving product innovation ●Acquisition Strategy Reignited: Completed two acquisitions so far this year, with additional acquisition opportunities actively under evaluation Management Commentary: 'The launch of our AI Center of Excellence marks a pivotal moment in CareCloud’s evolution,” said A. Hadi Chaudhry, Co-CEO of CareCloud. 'By building one of the largest dedicated healthcare AI teams globally, we are creating real-world solutions to automate clinical workflows, optimize revenue cycle management, and improve patient outcomes. This initiative is intended to accelerate our operational efficiency as well as positioning CareCloud at the forefront of intelligent healthcare transformation, driving sustainable profitability and long-term growth for ourselves and the healthcare providers who use our services. We are already using AI to enhance product development, including deploying specialty-specific versions of our EHR, to allow our providers to improve their productivity with cirrusAI Notes, and to automate some follow-up tasks which would otherwise require additional members of our operations team.” 'After record profits and a successful turnaround in 2024, we are excited to announce continued momentum and financial strength as demonstrated by achieving positive GAAP EPS in this quarter, the first time in the Company’s history since going public in 2014,” said Co-CEO Stephen Snyder. 'With two recent acquisitions and the launch of our AI Center of Excellence, CareCloud is not just responding to the market shift - we are leading it.” 'We are pleased to announce our fifth consecutive quarter of positive GAAP net income and an increase in year-to-date revenue, adjusted EBITDA and free cash flow year-over-year,” said Norman Roth, Interim CFO and Corporate Controller of CareCloud. 'We continue to pay our preferred stock dividends monthly out of internally generated free cash flow, while generating additional profits and cash flow which we are reinvesting for future growth. We have declared and paid preferred stock dividends every month during 2025.” Capital On June 30, 2025, the Company had 984,530 shares of Series A Preferred Stock and 1,511,372 shares of non-convertible Series B Preferred Stock outstanding. As of June 30, 2025, the Series A and B shares both accrued dividends at the rate of 8.75% per annum, based on the $25.00 per share liquidation preference (equivalent to $2.1875 annually per share), and they are redeemable at the Company’s option once the preferred stock dividends are brought current. Also as of June 30, 2025, the Company had 42,322,039 shares of common stock outstanding. 2025 Guidance: Poised for Growth CareCloud is reconfirming its earnings guidance for 2025, expecting: For the Fiscal Year Ending December 31, 2025 Forward-Looking Guidance Revenue $111 - $114 million Adjusted EBITDA $26 - $28 million GAAP Net Income Per Share (EPS) $0.10 - $0.13 The Company continues to anticipate full year 2025 revenue of approximately $111 to $114 million. Revenue guidance is based on management’s expectations regarding revenue from existing clients, organic growth in new client additions and anticipated number of small tuck-in acquisitions. Adjusted EBITDA is expected to be $26 to $28 million for the full year 2025 and reflects improvements from the Company’s cost reduction efforts. GAAP EPS is expected to be $0.10 to $0.13 for the full year 2025. Conference Call Information CareCloud management will host a conference call today at 8:30 a.m. Eastern Time to discuss the first half of 2025 results. The live webcast of the conference call and related presentation slides can be accessed at ir.carecloud.com/events. An audio-only option is available by dialing 201-389-0920 and referencing 'CareCloud Second Quarter 2025 Results Conference Call.” Investors who opt for audio-only will need to download the related slides at ir.carecloud.com/events. A replay of the conference call and related presentation slides will be available approximately three hours after conclusion of the call at the same link. An audio-only option can also be accessed by dialing 412-317-6671 and providing the access code 13754330. Use of Non-GAAP Financial Measures In our earnings releases, prepared remarks, conference calls, slide presentations, and webcasts, we use and discuss non-GAAP financial measures, as defined by SEC Regulation G. The GAAP financial measure most directly comparable to each non-GAAP financial measure used or discussed, and a reconciliation of the differences between each non-GAAP financial measure and the comparable GAAP financial measure, are included in this press release after the condensed consolidated financial statements. Our earnings press releases containing such non-GAAP reconciliations can be found in the Investor Relations section of our web site at ir.carecloud.com. Forward-Looking Statements This press release contains various forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements relate to anticipated future events, future results of operations or future financial performance. In some cases, you can identify forward-looking statements by terminology such as 'may,” 'might,” 'will,” 'shall,” 'should,” 'could,” 'intends,” 'expects,” 'plans,” 'goals,” 'projects,” 'anticipates,” 'believes,” 'seeks,” 'estimates,” 'forecasts,” 'predicts,” 'possible,” 'potential,” 'target,” or 'continue” or the negative of these terms or other comparable terminology. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Forward-looking statements in this press release include, without limitation, statements reflecting management’s expectations for future financial performance and operating expenditures, expected growth, profitability and business outlook, the impact of pandemics on our financial performance and business activities, and the expected results from the integration of our acquisitions. These forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are only predictions, are uncertain and involve substantial known and unknown risks, uncertainties and other factors which may cause our (or our industry’s) actual results, levels of activity or performance to be materially different from any future results, levels of activity or performance expressed or implied by these forward-looking statements. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all of the risks and uncertainties that could have an impact on the forward-looking statements, including without limitation, risks and uncertainties relating to the Company’s ability to manage growth, migrate newly acquired customers and retain new and existing customers, maintain cost-effective global operations, increase operational efficiency and reduce operating costs, predict and properly adjust to changes in reimbursement and other industry regulations and trends, retain the services of key personnel, develop new technologies, upgrade and adapt legacy and acquired technologies to work with evolving industry standards, compete with other companies’ products and services competitive with ours, manage and keep our information systems secure and other important risks and uncertainties referenced and discussed under the heading titled 'Risk Factors” in the Company’s filings with the Securities and Exchange Commission. The statements in this press release are made as of the date of this press release, even if subsequently made available by the Company on its website or otherwise. The Company does not assume any obligations to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made. About CareCloud CareCloud (Nasdaq: CCLD, CCLDO) brings disciplined innovation and generative AI solutions to the business of healthcare. Our suite of technology-enabled solutions helps clients increase financial and operational performance, streamline clinical workflows and improve the patient experience. More than 40,000 providers count on CareCloud to help them improve patient care while reducing administrative burdens and operating costs. Learn more about our products and services, including revenue cycle management (RCM), practice management (PM), electronic health records (EHR), artificial intelligence (AI), business intelligence (BI), patient experience management (PXM) and digital health, at carecloud.com. Follow CareCloud on LinkedIn, X and Facebook. For additional information, please visit our website at carecloud.com. To listen to video presentations by CareCloud’s management team, read recent press releases and view the latest investor presentation, please visit ir.carecloud.com. SOURCE CareCloud Company Contact: Norman Roth Interim Chief Financial Officer and Corporate Controller CareCloud, Inc. nroth@carecloud.comInvestor Contact: Stephen Snyder Co-Chief Executive Officer CareCloud, Inc. ir@carecloud.com CARECLOUD, INC.CONDENSED CONSOLIDATED BALANCE SHEETS ($ in thousands, except share and per share amounts) June 30, December 31, 2025 2024 (Unaudited) ASSETS Current assets: Cash $10,440 $5,145 Accounts receivable - net 13,563 12,774 Contract asset 3,955 4,334 Inventory 523 574 Current assets - related party 16 16 Prepaid expenses and other current assets 2,593 1,957 Total current assets 31,090 24,800 Property and equipment - net 5,828 5,290 Operating lease right-of-use assets 3,058 3,133 Intangible assets - net 15,512 18,698 Goodwill 19,192 19,186 Other assets 564 507 TOTAL ASSETS $75,244 $71,614 LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable $4,215 $4,565 Accrued compensation 3,324 1,817 Accrued expenses 4,909 4,951 Operating lease liability (current portion) 1,294 1,287 Deferred revenue (current portion) 1,232 1,212 Notes payable (current portion) 222 310 Contingent consideration (current portion) 330 - Dividend payable 714 5,438 Total current liabilities 16,240 19,580 Notes payable 86 26 Contingent consideration 426 - Operating lease liability 1,785 1,847 Deferred revenue 631 387 Total liabilities 19,168 21,840 COMMITMENTS AND CONTINGENCIES SHAREHOLDERS’ EQUITY: Preferred stock, $0.001 par value - authorized 7,000,000 shares. Series A, issued and outstanding 984,530 and 4,526,231 shares at June 30, 2025 and December 31, 2024, respectively. Series B, issued and outstanding 1,511,372 shares at June 30, 2025 and December 31, 2024. 2 6 Common stock, $0.001 par value - authorized 85,000,000 shares. Issued 43,062,838 and 16,997,035 shares at June 30, 2025 and December 31, 2024, respectively. Outstanding 42,322,039 and 16,256,236 shares at June 30, 2025 and December 31, 2024, respectively 43 17 Additional paid-in capital 122,635 121,046 Accumulated deficit (61,780) (66,630)Accumulated other comprehensive loss (4,162) (4,003)Less: 740,799 common shares held in treasury, at cost at June 30, 2025 and December 31, 2024 (662) (662)Total shareholders’ equity 56,076 49,774 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $75,244 $71,614 CARECLOUD, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)($ in thousands, except share and per share amounts) Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024 NET REVENUE $27,377 $28,090 $55,009 $54,052 OPERATING EXPENSES: Direct operating costs 14,480 15,242 29,944 30,419 Selling and marketing 1,118 1,664 2,249 3,434 General and administrative 4,358 4,028 8,690 7,749 Research and development 1,020 1,055 2,255 1,968 Depreciation and amortization 3,382 3,714 6,719 7,644 Restructuring costs 23 116 137 438 Total operating expenses 24,381 25,819 49,994 51,652 OPERATING INCOME 2,996 2,271 5,015 2,400 OTHER: Interest income 51 24 93 51 Interest expense (68) (288) (126) (653)Other expense - net (35) (294) (49) (287)INCOME BEFORE PROVISION FOR INCOME TAXES 2,944 1,713 4,933 1,511 Income tax provision 42",
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"snippet": "Delivers first quarter of positive GAAP EPS in Company’s history since going public, announces initial results from AI InitiativeSOMERSET, N.J., Aug. 05, 2025...",
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