Sight Sciences to Present at Two Upcoming Investor Conferences




Sight Sciences to Present at Two Upcoming Investor Conferences

MENLO PARK, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT) (Sight Sciences or the Company), an eyecare technology company focused on developing and commercializing innovative, interventional technologies intended to transform care and improve patients’ lives, today announced plans to present at the upcoming Stifel 2025 Healthcare Conference and the Piper Sandler 37th Annual Healthcare Conference, both in New York, NY.

Sight Sciences’ management is scheduled to present at the Stifel 2025 Healthcare Conference on Tuesday, November 11, 2025 at 8:20 am PT / 11:20 am ET.

Sight Sciences’ management is scheduled to present at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 5:30 am PT / 8:30 am ET. 

Interested parties may access a live and archived webcast of the fireside chat on the Investors section of the Company’s website at https://investors.sightsciences.com/.

About Sight Sciences
Sight Sciences is an eyecare technology company focused on developing and commercializing innovative and interventional solutions intended to transform care and improve patients’ lives. Using minimally invasive or non-invasive approaches to target the underlying causes of the world’s most prevalent eye diseases, Sight Sciences seeks to create more effective treatment paradigms that enhance patient care and supplant conventional outdated approaches. The Company’s OMNI^® Surgical System and OMNI^® Edge Surgical System are implant-free, minimally invasive glaucoma surgery technologies indicated in the United States to reduce intraocular pressure in adult patients with primary open-angle glaucoma. The OMNI Surgical System is CE Marked for the catheterization and transluminal viscodilation of Schlemm’s canal and cutting of the trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma. Glaucoma is the world’s leading cause of irreversible blindness. The SION^® Surgical System is a bladeless, manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork. The Company’s TearCare^® System is 510(k) cleared in the United States for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland disease (MGD), enabling clearance of gland obstructions by physicians to address the leading cause of dry eye disease.

Visit www.sightsciences.com for more information. 

Sight Sciences and TearCare are trademarks of Sight Sciences registered in the United States. OMNI and SION are trademarks of Sight Sciences registered in the United States, European Union and other territories.

CPT is a registered trademark of the American Medical Association.

© 2025 Sight Sciences. All rights reserved.  

Media contact:
pr@sightsciences.com

Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
Investor.Relations@Sightsciences.com

Tarsus Reports Third Quarter 2025 Financial Results and Recent Business Achievements




Tarsus Reports Third Quarter 2025 Financial Results and Recent Business Achievements

Delivered quarterly XDEMVY^® net sales of approximately $119 million, up approximately 147% year-over-year

Weekly multi-patient prescribers grew approximately 30% in the third quarter underscoring strong commercial momentum

Management to host conference call today, November 4, 2025, at 1:30 p.m. PT / 4:30 p.m. ET

IRVINE, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) — Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced financial results for the third quarter ended September 30, 2025.

“Our third quarter results, highlighted by nearly $119 million in XDEMVY sales, reflect the strength of our commercial model, the scale of engagement across eye care, and the impact we’re having on patients,” said Bobak Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus. “We’ve established a new category in eye care, and XDEMVY is now one of the best-selling prescription eye drops. Simultaneously, we are expanding our pipeline with more category-creating programs like ocular rosacea – another widespread condition with significant unmet need – that position Tarsus for sustained, long-term growth. With each new milestone, we are deepening our impact and shaping the future of eye care.”

Recent Business and Clinical Highlights

• XDEMVY is continuing on a strong growth trajectory with Q3 results of: 
  • $118.7 million in net product sales.
  • More than 103,000 bottles delivered to patients.
  • Broad, high-quality coverage, with more than 90% of commercial, Medicare and Medicaid lives covered, leading to a gross-to-net discount of 44.7%.

• Two years into launch, Tarsus is fundamentally changing how eye care professionals (ECPs) diagnose and treat Demodex blepharitis (DB).
  • More than 20,000 ECPs have written multiple prescriptions reflecting growing confidence and the consistent integration of XDEMVY into clinical practice.
  • At the end of Q3 2025, the number of ECPs prescribing more than one bottle per week increased by approximately 30% compared to Q2 2025.

• Tarsus continues to execute on its category-creation strategy, advancing a robust pipeline designed to establish new treatment categories, with plans to initiate:
  
  • A Phase 2 study of TP-04 (lotilaner ophthalmic gel) for the potential treatment of ocular rosacea (OR), a highly prevalent and underserved eye disease with no FDA-approved therapy, in December 2025, with topline data expected by year-end 2026.
  • A Phase 2 study of TP-05 (lotilaner oral tablet) for the potential prevention of Lyme disease, a novel, on-demand, oral tablet designed to kill ticks before they can transmit infection, in 2026.

Third Quarter 2025 Financial Results

• Product sales, net: were $118.7 million compared to $48.1 million for the same period in 2024, driven by more than 103,000 bottles of XDEMVY delivered to patients compared to more than 41,400 bottles delivered to patients in the prior year period.
• Cost of sales: were $8.3 million compared to $3.2 million for the same period in 2024, due to manufacturing costs related to XDEMVY, the royalty Tarsus pays on net product sales, and the amortization of the milestones paid to Tarsus’ licensor, which is being amortized over its remaining useful life.
• Research and development (R&D) expenses: were $16.3 million compared to $12.1 million for the same period in 2024. The increase was primarily due to $0.8 million of increased TP-04 program expenses, $2.9 million of increased payroll and personnel-related costs, $0.7 million of increased early-stage programs, and $0.4 million of increased other indirect expenses. These increases were partially offset by $0.8 million of decreased TP-05 program expenses. Total R&D non-cash stock compensation expense was $3.0 million, compared with $1.7 million in the same period in 2024.
• Selling, general and administrative (SG&A) expenses: were $108.6 million compared to $57.9 million for the same period in 2024. The increase was due primarily to $7.4 million of increased payroll and personnel-related costs (including non-cash stock-based compensation), $26.1 million of increased commercial and marketing costs, including direct-to-consumer advertising costs, as we continued our commercial launch of XDEMVY, and $17.2 million of increased variable costs including certain patient assistance programs, fees related to increased bottles dispensed, information technology applications, legal, professional, and other corporate expenses. Total SG&A non-cash stock compensation expense was $9.1 million, compared with $5.6 million in the same period in 2024.
• Net loss: was $12.6 million, compared to $23.4 million for the same period in 2024. Basic and diluted net loss per share for the quarter ended September 30, 2025 was $(0.30), compared with $(0.61) for the same period in 2024.
• Cash position: As of September 30, 2025, cash, cash equivalents and marketable securities were $401.8 million.

Year-to-Date 2025 Financial Results

• Product sales: were $299.7 million compared to $113.7 million for the same period in 2024, driven by approximately 266,000 bottles of XDEMVY delivered to patients compared to approximately 104,400 bottles delivered to patients in the prior year period.
• Cost of sales: were $19.8 million compared to $7.9 million for the same period in 2024, due to manufacturing costs related to XDEMVY, the royalty Tarsus pays on net product sales, and the amortization of the milestones paid to Tarsus’ licensor, which is being amortized over its remaining useful life.
• Research and development (R&D) expenses: were $46.3 million compared to $36.5 million for the same period in 2024. The increase was due to $5.1 million of increased compensation and other personnel-related expense (including non-cash stock-based compensation), $1.0 million of other indirect expenses, $2.6 million of increased early-stage programs, and $2.1 million of increased TP-04 program spend. These increases were partially offset by $0.6 million of decreased TP-05 program spend and $0.5 million of decreased TP-03 program spend. R&D non-cash stock compensation expense was $6.4 million, compared with $5.0 million in the same period in 2024.
• Selling, general and administrative (SG&A) expenses: were $296.6 million compared to $168.3 million for the same period in 2024. The increase was due primarily to $24.0 million of increased payroll and personnel-related costs (including non-cash stock-based compensation), $81.5 million of increased commercial and marketing costs, including direct-to-consumer advertising costs, related to the commercial launch of XDEMVY, and $22.9 million of increased variable costs including certain patient assistance programs, fees related to increased bottles dispensed, information technology applications, legal, professional and other corporate expenses. SG&A non-cash stock compensation expense was $20.5 million, compared with $14.9 million in the same period in 2024.
• Net loss: was $58.0 million, compared to $92.4 million for the same period in 2024. Year-to-date basic and diluted net loss per share was $(1.40), compared with $(2.48) for the same period in 2024.

Conference Call and Webcast
Tarsus will host a conference call and webcast to discuss its third quarter 2025 financial results and business highlights today, November 4, 2025, at 1:30 p.m. PT / 4:30 p.m. ET. A live webcast will be available on the events section of the Tarsus website. A recorded version of the call will be available on the website shortly after the completion of the call and will be archived there for at least 90 days.

About XDEMVY^®
XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop designed to treat Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found the XDEMVY eye drop to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis.

XDEMVY Indication and Important Safety Information

INDICATIONS AND USAGE
XDEMVY is indicated for the treatment of Demodex blepharitis.

Most common side effects: The most common side effect in clinical trials was stinging and burning in 10% of patients. Other side effects in less than 2% of patients were chalazion/hordeolum and punctate keratitis.

For additional information, please see full prescribing information available at https://xdemvy.com/.

About TP-03
TP-03 (lotilaner ophthalmic solution) 0.25% is a novel therapeutic designed to treat Demodex blepharitis by targeting and eradicating the root cause of disease – Demodex mite infestation. It was approved by the FDA in 2023 under the brand name XDEMVY^® for the treatment of Demodex blepharitis. Lotilaner is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific gamma-aminobutyric acid-gated chloride (GABA-Cl) channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eye lash follicles where the mites reside.

About TP-04
TP-04 is an investigational sterile aqueous gel formulation of lotilaner. Tarsus is studying TP-04 for the potential treatment of ocular rosacea (OR).

About TP-05
TP-05 is an investigational oral systemic formulation of lotilaner. TP-05 is believed to be the only non-vaccine, drug-based, preventative therapeutic in development designed to kill ticks to potentially prevent Lyme disease transmission.

About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. XDEMVY (lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-04 for the potential treatment of ocular rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease, all of which are in Phase 2.

Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the potential commercial success and growth of XDEMVY in Demodex blepharitis, including market size, acceptance, demand, prescription fill rate and adoption rate for XDEMVY; our ability to successfully continue our new direct-to-consumer campaign; our ability to achieve and maintain distribution and patient access for XDEMVY and breadth of payer coverage; our ability to continue to educate the market about Demodex blepharitis; our ability to initiate planned clinical studies; anticipated regulatory and development milestones including potential Europe and Japan regulatory pathways and approval for XDEMVY; the results of our clinical studies; the test results of our pipeline formulations; our ability to continue investing in our business and actively evaluate external opportunities, and the quotations of Tarsus’ management. The words, without limitation, “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus is heavily dependent on the successful commercialization of its lead product, XDEMVY for the treatment of Demodex blepharitis and the development and regulatory approval and commercialization of its current and future product candidates; Tarsus’ ability to obtain and maintain regulatory approval for and successfully commercialize its products, including XDEMVY for the treatment of Demodex blepharitis, and its product candidates to meet existing and future regulatory standards; Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it will continue to incur significant expenses and losses for the foreseeable future; Tarsus’ capital requirements are difficult to predict and may change; Tarsus may need to obtain additional funding to achieve its goals and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force Tarsus to delay, reduce, or eliminate its product development programs, commercialization efforts or other operations; Tarsus may not be successful in educating healthcare professionals and the market about the need for treatments specifically for Demodex blepharitis and other diseases targeted by XDEMVY or our product candidates; the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus expects to expand its development, regulatory, operational, sales, and marketing capabilities and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for XDEMVY and Tarsus’ product candidates, particularly TP-04 for the potential treatment of ocular rosacea, as well as TP-05 for the potential prevention of Lyme disease, have not been established with precision and may be smaller than estimated; the results of Tarsus’ earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus’ planned clinical trials could result in increased costs, delay or limit its ability to generate revenue and adversely affect its commercial prospects; if Tarsus is unable to obtain and maintain sufficient intellectual property protection for its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus’ competitors could develop and commercialize products similar or identical to Tarsus’ products; and if Tarsus is unable to access capital (including but not limited to cash, cash equivalents, and credit facilities) and/or loses capital, as a result of potential failure of any financial institutions that Tarsus does business with directly or indirectly. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statements and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus’ Form 10-K for the year ended December 31, 2024 filed on February 25, 2025 and the most recent Form 10-Q quarterly filing filed with the SEC on November 4, 2025, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this earnings release are based on the current expectations of Tarsus’ management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Ceribell Reports Third Quarter 2025 Financial Results




Ceribell Reports Third Quarter 2025 Financial Results

SUNNYVALE, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) — CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today reported financial results for the quarter ended September 30, 2025.

Third Quarter 2025 & Recent Highlights

• Reported total revenue of $22.6 million in the third quarter of 2025, a 31% increase compared to the same period in 2024
• Achieved gross margin of 88% compared to 87% for the same period in 2024 
• Ended the quarter with 615 total active accounts 
• Appointed Erica Rogers to the Board of Directors

“We are encouraged by our third quarter performance, which reflects strong commercial execution and continued momentum in adoption of the Ceribell System,” said co-founder and CEO Jane Chao, Ph.D. “Looking ahead, our focus remains on generating robust clinical evidence to help establish point-of-care EEG as a new standard of care for seizure management in the acute care setting. Our progress this quarter underscores the foundational work we’ve done to unlock what we believe to be a $2 billion addressable market opportunity and reinforces our leadership position built on differentiated technology, extensive clinical and economic data, and continued innovation.”

Third Quarter 2025 Financial Results
Total revenue in the third quarter of 2025 was $22.6 million, a 31% increase from $17.2 million in the third quarter of 2024. The increase was primarily driven by continued commercial traction, resulting from expansion into new accounts and continued adoption within the company’s active account base. Product revenue for the third quarter of 2025 was $17.0 million, representing an increase of 28% from $13.3 million in the third quarter of 2024. Subscription revenue for the third quarter of 2025 was $5.6 million, representing an increase of 44% from $3.9 million in the third quarter of 2024.

Gross profit in the third quarter of 2025 was $19.9 million, compared to $15.0 million for the third quarter of 2024. Gross margin for the third quarter of 2025 was 88%, compared to 87% for the same period in 2024.

Operating expenses in the third quarter of 2025 were $34.6 million, compared to $24.9 million for the third quarter of 2024, representing an increase of 39%. The increase in operating expenses was primarily attributable to investments in the company’s commercial organization, increased headcount to support the growth of the business, legal expenses, and expenses related to operating as a public company.

Net loss in the third quarter of 2025 was $13.5 million, or $0.37 net loss per share, compared to a net loss of $10.4 million, or $1.85 net loss per share, for the same period in 2024.

Cash, cash equivalents, and marketable securities totaled $168.5 million as of September 30, 2025.

2025 Financial Outlook
Ceribell is raising its revenue guidance for the full year 2025 to a range of $87 million to $89 million, representing growth of approximately 33% to 36% over the company’s prior year revenue.

Webcast and Conference Call Details
Ceribell will host a conference call today, November 4, 2025, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its third quarter 2025 financial results. Investors interested in listening to the conference call may do so by dialing (800) 715-9871 for domestic callers or (646) 307-1963 for international callers and providing access code 9394689. A live and archived webcast of the event will be available on the “Investor Relations” section of the Ceribell website at https://investors.ceribell.com/.

Forward-Looking Statements
Except where otherwise noted, the information contained in this earnings release and the related attachments is as of November 4, 2025. We assume no obligation to update any forward-looking statements contained in this earnings release and the related attachments as a result of new information or future events or developments. This earnings release and the related attachments contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about, among other topics, the anticipated rate and impact of tariffs on our estimated gross margins; our finished goods headband product inventory and the duration of supply of finished goods; revenue associated with subscription products; our anticipated operating and financial performance, including financial guidance and projections; business plans, strategy, goals and prospects; expectations for our products; and other statements that are not statements of historical fact. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any potential outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they refer to future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words of similar meaning. Ceribell’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market acceptance and adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; the manufacturing of a substantial number of our product components and their assembly in China and Vietnam; product defects or complaints and related liability; the complexity, timing, expense, and outcomes of clinical studies; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; and other risks and uncertainties, including those described under the heading “Risk Factors” in our Registration Statement on Form S-1, Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other reports filed with the U.S. Securities and Exchange Commission (“SEC”). These filings, when made, are available on the Investor Relations section of our website at https://investors.ceribell.com/ and on the SEC’s website at https://sec.gov/.

About CeriBell, Inc. 
Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. Ceribell has developed the Ceribell System, a novel, point-of-care electroencephalography (“EEG”) platform specifically designed to address the unmet needs of patients in the acute care setting. By combining proprietary, highly portable, and rapidly deployable hardware with sophisticated artificial intelligence (“AI”)-powered algorithms, the Ceribell System enables rapid diagnosis and continuous monitoring of patients with neurological conditions. The Ceribell System is FDA-cleared for detecting suspected seizure activity and currently utilized in intensive care units and emergency rooms across the U.S. Ceribell is headquartered in Sunnyvale, California. For more information, please visit www.ceribell.com or follow the company on LinkedIn.

Investor Contacts
Brian Johnston or Laine Morgan
Gilmartin Group
Investors@ceribell.com 

Media Contact
Brian Price
Press@ceribell.com 

Catalyst Pharmaceuticals Recognized Among BioSpace 2026 Best Places to Work




Catalyst Pharmaceuticals Recognized Among BioSpace 2026 Best Places to Work

CORAL GABLES, Fla., Nov. 04, 2025 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that it has been named as one of the BioSpace 2026 Best Places to Work for the second consecutive year, ranking 13 among 30 U.S. employers in the small company category.

“We are honored to be named on the BioSpace 2026 Best Places to Work list for a second consecutive year, which is a testament to the exceptional team we’ve built at Catalyst,” said Richard J. Daly, president and CEO of Catalyst. “Our culture is rooted in our shared mission to deliver life-changing therapies to patients living with rare diseases, and we’re committed to creating an environment where empowerment, passion, and empathy thrive. This recognition celebrates not just our workplace, but the dedication of every team member who works tirelessly to make a meaningful impact on patients’ lives.”

BioSpace, the leading source for life sciences news and careers, includes 50 U.S. operating employers in its Best Places to Work list that have been recognized as the most sought-after in the industry by the life sciences community. Catalyst is thrilled to have been included in the small employer category.

This is BioSpace’s fifth Best Places to Work list. The list demonstrates a company’s desirability in the recruitment marketplace, based on the votes and ratings of thousands of life science community members. BioSpace considers each organization’s merits with particular emphasis on culture, career growth and development opportunities, leadership and innovation.

About Best Places to Work
Nominations for Best Places to Work were open in June 2025. Voting was conducted in August 2025. BioSpace reviewed the votes and rankings submitted by over 7,500 life sciences professionals. Respondents were asked to identify their top three most desirable biopharma companies, segmented by large (more than 1,000+ employees) and small (less than 1,000 employees) companies. Respondents were also asked to rate their top choice organization on attributes including compensation, innovation, career growth opportunities, leadership, culture, diversity, equity and inclusion, reputation, and flexibility and remote work.

About BioSpace
BioSpace is the hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe. Learn more and subscribe at www.biospace.com.

About Catalyst Pharmaceuticals, Inc.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence, which remains the cornerstone of our commercial strategy, while continuously evaluating strategic opportunities to expand our global footprint. Catalyst, headquartered in Coral Gables, Fla., was recognized on the Forbes 2025 list as one of America’s Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America’s Fastest-Growing Companies.

For more information, please visit Catalyst’s website at www.catalystpharma.com.

CONTACT: Investor Contact
Melissa Kendis, Catalyst Pharmaceuticals, Inc.
(305) 420-3200
IR@catalystpharma.com

Media Contact
David Schull or Olipriya Das, Russo Partners
(858) 717-2310, 646 942 5588
david.schull@russopartnersllc.com, Olipriya.das@russopartnersllc.com

BioSpace Contact
Chantal Dresner
VP of Marketing, BioSpace
chantal.dresner@biospace.com

PROCEPT BioRobotics Reports Third Quarter 2025 Financial Results and Issues 2026 Revenue Guidance




PROCEPT BioRobotics Reports Third Quarter 2025 Financial Results and Issues 2026 Revenue Guidance

SAN JOSE, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) — PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today reported unaudited financial results for the quarter ended September 30, 2025.

Recent Highlights

• Total revenue of $83.3 million for the third quarter of 2025, an increase of 43% compared to the prior year period in 2024
• U.S. handpiece and consumables revenue of $44.4 million for the third quarter of 2025, an increase of 50% compared to the prior year period in 2024
• The installed base in the U.S. increased by 58 robotic systems in the third quarter of 2025
• U.S. system and rental revenue of $24.7 million for the third quarter of 2025, an increase of 26% compared to the prior year period in 2024
• International revenue of $9.4 million for the third quarter of 2025, an increase of 53% compared to the prior year period in 2024
• Maintained fiscal year 2025 total revenue guidance of approximately $325.5 million, an increase of 45% compared to the prior year period in 2024
• Issued fiscal year 2026 total revenue guidance in the range of $410 to $430 million, representing growth of 26% to 32% compared to fiscal 2025 revenue guidance of $325.5 million.

“In my initial weeks as CEO, I am pleased to report we delivered a strong performance. We accelerated U.S. system placements, demonstrating strong demand for the HYDROS® Robotic System, and achieved 43% year over year global revenue growth,” said Larry Wood, chief executive officer. “This quarter’s results underscore the strength of our business and the growing adoption of Aquablation therapy. My first two months at PROCEPT have only deepened my confidence in our significant growth potential. We remain focused on expanding awareness of Aquablation® therapy, driving patient activation and advancing our mission.”

Third Quarter 2025 Financial Results

Total revenue for the third quarter of 2025 was $83.3 million, an increase of 43% compared to the prior year period. U.S. revenue was $73.9 million, representing growth of 42% compared to the prior year period. The increase was primarily driven by system sales to new hospital customers and increased handpiece revenue. U.S. handpiece and consumable revenue for the third quarter of 2025 was $44.4 million, an increase of 50% compared to the prior year period. U.S. system revenue for the third quarter of 2025 was $24.7 million, an increase of 26% compared to the prior year period. As of September 30, 2025, the install base of robotic systems in the U.S. was 653 systems. International revenue was $9.4 million for the quarter, an increase of 53% compared to the prior year period.

Gross margin for the third quarter 2025 was 65% compared to 63% in the prior year period. Gross margin expansion in the third quarter was due to improved operational efficiencies and overhead absorption, modestly offset by increased tariff expenses.

Operating expenses in the third quarter of 2025 were $77.2 million, compared with $59.3 million in the prior year period. The increase in operating expenses was primarily due to expenses to expand the commercial organization, increased research and development expenses, increased general and administrative expenses, and one-time expenses associated with the executive leadership transition.

Net loss was $21.4 million for the third quarter of 2025, compared to a loss of $21.0 million in the prior year period. Adjusted EBITDA was a loss of $7.4 million for the third quarter of 2025, compared to a loss of $12.4 million in the prior year period.

Cash, cash equivalents and restricted cash balances as of September 30, 2025, totaled $297.3 million.

Full Year 2025 Financial Guidance

• The Company reiterates revenue for the full year 2025 to be approximately $325.5 million, which represents 45% growth over the Company’s prior year revenue.
• The Company expects full year 2025 gross margins in the range of 64.0% to 64.5%. The Company expects a gross margin headwind of approximately $2.0 million in the fourth quarter, attributable to tariff-related costs.
• The Company reiterates full year 2025 total operating expense of approximately $302.0 million.
• The Company reiterates full year 2025 Adjusted EBITDA loss to be approximately ($35.0) million.

Full Year 2026 Financial Guidance

• The Company projects revenue for the full year 2026 to be in the range of $410 to $430 million, which represents growth of 26% to 32% over the Company’s 2025 revenue guidance range.

Adjusted EBITDA is a financial measure that is not prepared in accordance with generally accepted accounting principles in the United States (GAAP). For more information about the Company’s use of non-GAAP financial measures, please see the section below titled “Use of Non-GAAP Financial Measures (Unaudited).

Webcast and Conference Call Information
PROCEPT BioRobotics will host a conference call to discuss the third quarter 2025 financial results on Tuesday, November 4, 2025, at 4:30 p.m. Eastern Time.

Investors interested in listening to the conference call may do so by following one of the below links:

• Webcast link for interested listeners:
  • https://edge.media-server.com/mmc/p/ojteo5eq/  
• Dial-in registration for sell-side research analysts:
  • https://register-conf.media-server.com/register/BIcd60b3c747ce43d491c58d7151c12c2a  

About PROCEPT BioRobotics Corporation
PROCEPT BioRobotics’ mission is to revolutionize BPH treatment globally in partnership with urologists by delivering best-in-class robotic solutions that positively impact patients and drive value. PROCEPT BioRobotics manufactures the AQUABEAM® and HYDROS® Robotic Systems. The HYDROS® Robotic System is the only AI-Powered, robotic technology that delivers Aquablation therapy. PROCEPT BioRobotics designed Aquablation therapy to deliver effective, safe, and durable outcomes for males suffering from lower urinary tract symptoms or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. The Company has developed a significant and growing body of clinical evidence with over 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy.

Use of Non-GAAP Financial Measures (Unaudited)
This press release references Adjusted EBITDA, a financial measure that is not prepared in accordance with generally accepted accounting principles in the United States (GAAP). The Company defines Adjusted EBITDA as earnings before interest expense, taxes, depreciation and amortization and stock-based compensation. Non-GAAP financial measures are not a substitute for or superior to measures of financial performance prepared in accordance with GAAP and should not be considered as an alternative to any other performance measures derived in accordance with GAAP.

The Company believes that presenting Adjusted EBITDA provides useful supplemental information to investors about the Company in understanding and evaluating its operating results, enhancing the overall understanding of its past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by its management in financial and operational decision making. However, there are a number of limitations related to the use of non-GAAP measures and their nearest GAAP equivalents. For example, other companies may calculate non-GAAP measures differently, or may use other measures to calculate their financial performance, and therefore any non-GAAP measures the Company uses may not be directly comparable to similarly titled measures of other companies.

Forward Looking Statements
This release contains forward‐looking statements within the meaning of federal securities laws, including with respect to the Company’s projected financial performance for full year 2025 and 2026, statements regarding the potential utilities, values, benefits and advantages of Aquablation therapy performed using PROCEPT BioRobotics’ products, including AquaBeam or Hydros Robotic Systems, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on the Company’s current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which the Company is not currently aware.   Forward-looking statements may include statements regarding financial guidance, market opportunity and penetration, clinical trial outcomes, the Company’s possible or assumed future results of operations, including descriptions of the Company’s revenues, gross margins, profitability, operating expenses, installed base growth, commercial momentum and overall business strategy. Forward‐looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward‐looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward‐looking statements as a result of these risks and uncertainties. These risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s annual report on Form 10-K filed with the SEC on February 27, 2025, and amended on April 11, 2025, and subsequent quarterly reports on Form 10-Q. PROCEPT BioRobotics does not undertake any obligation to update forward‐looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward‐looking statements contained herein. These forward-looking statements should not be relied upon as representing PROCEPT BioRobotics’ views as of any date subsequent to the date of this press release.

Important Safety Information
All surgical treatments have inherent and associated side effects. For a list of potential side effects visit https://aquablation.com/safety-information/ 

Investor Contact:
Matt Bacso
VP, Investor Relations and Business Operations
m.bacso@procept-biorobotics.com 

PROCEPT BioRobotics Corporation
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in thousands)

PROCEPT BioRobotics Corporation
REVENUE BY TYPE AND GEOGRAPHY
(Unaudited, in thousands)

Alvotech Announces Webcast on November 13, 2025 to Report Financial Results for the First Nine Months of 2025 and Provide a Business Update




Alvotech Announces Webcast on November 13, 2025 to Report Financial Results for the First Nine Months of 2025 and Provide a Business Update

REYKJAVIK, ICELAND (November 4, 2025) – Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first nine months of the year ended September 30, 2025, after U.S. markets close on Wednesday, November 12, 2025.  Alvotech will also conduct a conference call to present the financial results on Thursday November 13, 2025, at 8:00 am EST (13:00 GMT, 14:00 CET). On the call, management will provide a business update, including the status of pending approvals in the U.S. and Europe. A call in number is available for participants in the Q&A. Live audio of the conference call will also be webcast and a recording made available on Alvotech’s investor portal.

Information on how to access the webcast or participate by conference call is posted at https://investors.alvotech.com/events/event-details/q3-2025-earnings. An audio recording of the webcast will be archived and available for replay for 90 days after the event.

About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com

Please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.

Alvotech Announces Webcast on November 13, 2025 to Report Financial Results for the First Nine Months of 2025 and Provide a Business Update




Alvotech Announces Webcast on November 13, 2025 to Report Financial Results for the First Nine Months of 2025 and Provide a Business Update

REYKJAVIK, Iceland, Nov. 04, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first nine months of the year ended September 30, 2025, after U.S. markets close on Wednesday, November 12, 2025. Alvotech will also conduct a conference call to present the financial results on Thursday November 13, 2025, at 8:00 am EST (13:00 GMT, 14:00 CET). On the call, management will provide a business update, including the status of pending approvals in the U.S. and Europe. A call in number is available for participants in the Q&A. Live audio of the conference call will also be webcast and a recording made available on Alvotech’s investor portal.

Information on how to access the webcast or participate by conference call is posted at https://investors.alvotech.com/events/event-details/q3-2025-earnings. An audio recording of the webcast will be archived and available for replay for 90 days after the event.

About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com

Please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.

Ultragenyx Announces Sale of a Portion of Future North American Royalties on Crysvita® (burosumab) for $400 Million to OMERS Life Sciences




Ultragenyx Announces Sale of a Portion of Future North American Royalties on Crysvita® (burosumab) for $400 Million to OMERS Life Sciences

Bolsters balance sheet with non-dilutive capital at an attractive cost

Beginning in January 2028 OMERS will receive an additional 25% of the North American Crysvita® royalty interest capped at 1.55 times the purchase price

Proceeds to fund four expected launches, setting the company up for the next stage of growth

NOVATO, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, today announced the sale, for $400 million, of an additional 25% of the company’s royalty interest from Kyowa Kirin Co., Ltd on the future sales of Crysvita® (burosumab) in the United States (U.S.) and Canada to OMERS, one of Canada’s largest defined benefit pension plans. OMERS will receive the additional 25% royalty interest on net sales of Crysvita® beginning in January 2028. Pursuant to the new agreement, OMERS will also continue to receive 30% of Crysvita® net sales in the U.S. and Canada following the achievement of the 2022 royalty purchase agreement transaction’s cap of 1.45 times the purchase price. Total payments to OMERS pursuant to the new agreement are capped at 1.55 times the purchase price.

“Crysvita continues its strong growth trajectory, treating more than 3,000 patients and generating greater than $4 billion of cumulative U.S. and Canada sales since launching over seven years ago. The cash from this financing and the payment holiday through January 2028 bolsters our balance sheet to help us deliver on our expected launches and our path to full year GAAP profitability in 2027,” said Howard Horn, chief financial officer and executive vice president, corporate strategy of Ultragenyx. “Building on our 2022 transaction, OMERS again offered the most attractive financial package and cost of capital, and we are pleased to expand our relationship with them.”

“Ultragenyx has been an outstanding partner and a leader in the rare disease space for over a decade. Crysvita has made a difference in the lives of thousands of pediatric and adult patients with rare bone diseases and we are proud to expand our investment in this growing product,” said Rob Missere, managing director and head of life sciences at OMERS. “This deal closely aligns with our life sciences investment strategy at OMERS and our mandate of delivering steady, long-term returns to our 640,000 members.”

TD Cowen acted as exclusive financial advisor to Ultragenyx on the transaction. Gibson, Dunn, & Crutcher LLP acted as legal advisor to Ultragenyx. Davies Ward Phillips & Vineberg LLP, Latham & Watkins LLP, and Sidley Austin LLP acted as legal adviser to OMERS.

About Crysvita

CRYSVITA was developed and commercialized through a global collaboration and licensing agreement between Kyowa Kirin and Ultragenyx. Ultragenyx currently leads commercial efforts in Latin America and Turkey, while Kyowa Kirin leads efforts in the U.S., Canada, Europe, Asia, Australia, and the Middle East in addition to global manufacturing and distribution.

About Ultragenyx
Ultragenyx is a biopharmaceutical company committed to bringing novel therapies to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved medicines and treatment candidates aimed at addressing diseases with high unmet medical need and clear biology, for which there are typically no approved therapies treating the underlying disease.

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.

For more information on Ultragenyx, please visit the company’s website at: www.ultragenyx.com.

About OMERS Life Sciences and OMERS

OMERS Life Sciences provides royalty financings and other non-dilutive solutions to biopharma companies and academic institutions.

OMERS is a jointly sponsored, defined benefit pension plan, with more than 1,000 participating employers ranging from large cities to local agencies, and 640,000 active, deferred and retired members. Our members include union and non-union employees of municipalities, school boards, local boards, transit systems, electrical utilities, emergency services and children’s aid societies across Ontario. OMERS teams work in Toronto, London, New York, Amsterdam, Luxembourg, Singapore, Sydney and other major cities across North America and Europe – serving members and employers, and originating and managing a diversified portfolio of high-quality investments in government bonds, public and private credit, public and private equities, infrastructure and real estate.

Forward-Looking Statements and Use of Digital Media

Except for the historical information contained herein, the matters set forth in this press release, including statements related to Ultragenyx’s expectations and projections regarding its future operating results and financial performance, including the company’s timeline to achieve profitability, anticipated cost or expense reductions, the timing, progress and plans for its clinical programs and clinical studies, future regulatory interactions, the components and timing of regulatory submissions, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause the company’s clinical development programs, commercial success of its products and product candidates, continued collaboration with third parties, 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 company’s ability to achieve profitability on its expected timeline, or at all, the uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals, risks related to serious or undesirable side effects of our product candidates, the company’s ability to achieve its projected development goals in its expected timeframes, risks related to reliance on third party partners to conduct certain activities on the company’s behalf, our limited experience in generating revenue from product sales, risks related to product liability lawsuits, our dependence on Kyowa Kirin for the commercialization of Crysvita in certain major markets, including the U.S. and Canada, and for our commercial supply of Crysvita in those markets, fluctuations in buying or distribution patterns from distributors and specialty pharmacies, smaller than anticipated market opportunities for the company’s products and product candidates, manufacturing risks, our ability to successfully manage the expansion of our company, competition from other therapies or products, regulatory scrutiny of the company’s products and product candidates, the company’s limited experience as a company in operating its own manufacturing facility, market acceptance of our products, uncertainty related to insurance coverage and reimbursement, and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the company’s future operating results and financial performance, the timing of clinical trial activities and reporting results from same, and the availability or commercial potential of Ultragenyx’s products and drug candidate. Ultragenyx undertakes no obligation to update or revise any forward-looking statements.

For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Ultragenyx in general, see Ultragenyx’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 6, 2025, and its subsequent periodic reports filed with the SEC.

In addition to its SEC filings, press releases and public conference calls, Ultragenyx uses its investor relations website and social media outlets to publish important information about the company, including information that may be deemed material to investors, and to comply with its disclosure obligations under Regulation FD. Financial and other information about Ultragenyx is routinely posted and is accessible on Ultragenyx’s Investor Relations website (https://ir.ultragenyx.com/) and LinkedIn website (https://www.linkedin.com/company/ultragenyx-pharmaceutical-inc-/).

Contacts
Ultragenyx Pharmaceutical Inc.
Investors
Joshua Higa
ir@ultragenyx.com

Media
Jess Rowlands
media@ultragenyx.com

OMERS
Don Peat
416-417-7385
dpeat@omers.com

Chemed Corporation to Present at the UBS 2025 Global Healthcare Conference




Chemed Corporation to Present at the UBS 2025 Global Healthcare Conference

CINCINNATI, Ohio, Nov. 04, 2025 (GLOBE NEWSWIRE) — Chemed Corporation (NYSE: CHE) today announced that it will deliver a presentation at the UBS 2025 Global Healthcare Conference on Tuesday, November 11, 2025, at approximately 2:00 p.m. (ET) at the PGA National Resort in Palm Beach Gardens, Florida.

The presentation will be webcast live and can be accessed, along with the presentation materials, through the Chemed website at www.chemed.com (Investor Relations). The webcast replay will be available within 24 hours of the live presentation and will be accessible for 90 days.

Listed on the New York Stock Exchange and headquartered in Cincinnati, Ohio, Chemed Corporation (www.chemed.com) operates two wholly owned subsidiaries: VITAS Healthcare and Roto-Rooter. VITAS is the nation’s largest provider of end-of-life hospice care and Roto-Rooter is the nation’s leading provider of plumbing and drain cleaning services.

Statements in this press release or in other Chemed communications may relate to future events or Chemed’s future performance. Such statements are forward-looking statements and are based on present information Chemed has related to its existing business circumstances. Investors are cautioned that such forward-looking statements are subject to inherent risk and that actual results may differ materially from such forward-looking statements. Further, investors are cautioned that Chemed does not assume any obligation to update forward-looking statements based on unanticipated events or changed expectations.

CONTACT:
Michael D. Witzeman                              
(513) 762-6714

Hengrui Pharma and Kailera Therapeutics Announce Additional Data from Phase 3 Obesity Trial in China of Dual GLP-1/GIP Receptor Agonist HRS9531 




Hengrui Pharma and Kailera Therapeutics Announce Additional Data from Phase 3 Obesity Trial in China of Dual GLP-1/GIP Receptor Agonist HRS9531 

– Mean weight loss of 19.2%^I at 6 mg with no plateau and favorable safety profile in 48-week Phase 3 clinical trial –

– Data builds on previously reported Phase 2 results that showed mean weight loss of 23.6%^I at 8 mg at week 36 with no plateau –

– NDA submitted in China by Hengrui; Kailera plans to start global Phase 3 trials by year-end evaluating multiple maintenance doses including 8 mg –

SHANGHAI and WALTHAM, Mass., Nov. 04, 2025 (GLOBE NEWSWIRE) — Hengrui Pharma (Hengrui), a global pharmaceutical company focused on scientific and technological innovation, and Kailera Therapeutics, Inc. (Kailera), a clinical-stage biopharmaceutical company focused on advancing a differentiated, late-stage portfolio of next-generation therapies for the treatment of obesity, today announced the presentation of additional data from Hengrui’s Phase 3 clinical trial¹ (GEMINI-1) of a once-weekly subcutaneous injection of HRS9531, a novel dual GLP-1/GIP receptor agonist, in individuals living with obesity or overweight in China (NCT06396429) at ObesityWeek^® 2025, the annual meeting of The Obesity Society (TOS).

The trial met both co-primary endpoints, including superior weight loss with HRS9531 (2 mg, 4 mg, and 6 mg) and greater percentage of participants achieving body weight reductions of at least 5% compared to placebo at 48 weeks. Hengrui submitted a marketing authorization application to the National Medical Products Administration (NMPA) in China for chronic weight management of HRS9531 in adults, which has recently been accepted. Kailera plans to begin global Phase 3 trials of HRS9531 as KAI-9531 evaluating multiple doses, including 8 mg and 10 mg, and longer treatment durations by year-end 2025.

Efficacy Summary

• Hengrui’s Phase 3 trial enrolled 567 participants with a mean baseline body weight of 93 kg (205 lb) and evaluated HRS9531 doses of 2 mg, 4 mg, and 6 mg compared to placebo.
• Based on the hypothetical strategy estimand^I, participants taking HRS9531 achieved a mean weight loss of 11.2% (2 mg), 17.4% (4 mg) and 19.2% (6 mg), compared to placebo (1.4%).
• Based on the treatment policy estimand^II, participants taking HRS9531 achieved a mean weight loss of 10.7% (2 mg), 16.4% (4 mg) and 17.7% (6 mg), compared to placebo (1.4%).
• Based on the treatment policy estimand^II, 68.1% (2 mg), 88.0% (4 mg) and 85.7% (6 mg) of HRS9531-treated participants achieved at least 5% weight loss.
• Based on the treatment policy estimand^II, 44.4% of participants taking HRS9531 (6 mg) achieved at least 20% weight loss.
• Treatment with HRS9531 resulted in robust improvement in cardiometabolic risk factors including blood pressure, lipids, measures of insulin resistance and hsCRP (high sensitivity C reactive protein).

Safety and Tolerability Summary

• The trial results demonstrated a safety and tolerability profile consistent with GLP-1-based treatments and the previously reported HRS9531 Phase 2 clinical data.
• Most treatment-emergent adverse events (TEAEs) were mild to moderate and were gastrointestinal-related.
• Permanent treatment discontinuation rates due to TEAEs were very low with 0.7% (1 participant, 2 mg), 0.7% (1 participant, 4 mg), 1.4% (2 participants, 6 mg) and 0% (placebo).

In previously reported Phase 2 clinical trial² (NCT06054698) results evaluating the 8 mg dose of HRS9531, participants taking HRS9531 achieved a mean weight loss of 23.6% (21.7% placebo-adjusted)^I at week 36, with no plateau in weight loss and a favorable safety profile consistent with other GLP-1-based treatments. Kailera’s global Phase 3 program is evaluating multiple maintenance doses, including 8 mg and 10 mg, and at least 52 weeks of maintenance dosing. The company plans to initiate this program by year-end 2025. The Phase 3 program is comprised of three trials evaluating KAI-9531: one in adults with a BMI greater than 30 kg/m² or greater than 27 kg/m² with at least one comorbidity and without type 2 diabetes, another in adults with BMI of greater than 27 kg/m² and type 2 diabetes, and a third in adults with a BMI of greater than 35 kg/m² and without type 2 diabetes. 

“We are proud to present the data from this important clinical trial that showed impressive and sustained weight loss and optimization of multiple cardiometabolic risk factors, alongside a favorable safety and tolerability profile,” said Hong Chen, Head of Metabolism Department I of Hengrui Pharma. “We believe HRS9531 has the potential to make a meaningful difference in the lives of people living with obesity.”

“The HRS9531 6 mg results further validate the potential of KAI-9531 to be a transformative therapy for patients living with obesity and overweight, and we’re excited to start our global Phase 3 program by year-end to evaluate both higher doses and longer treatment durations to unlock the full potential of KAI-9531,” said Ron Renaud, President and Chief Executive Officer, Kailera. “We look forward to advancing our mission to deliver innovative therapies with the potential to meaningfully improve the lives of people around the world needing highly effective, sustainable weight loss.”

The presentation is accessible on the Scientific Publications section of the Kailera website.

About the GEMINI-1 Clinical Trial
The GEMINI-1 clinical trial was a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical study (NCT06396429) conducted by Hengrui in China to evaluate the efficacy and safety of HRS9531 injection in adults (≥18 years of age) with obesity (BMI ≥ 28 kg/m²) or overweight (BMI ≥ 24 kg/m²) and at least one weight-related comorbidity without diabetes. The study enrolled 567 participants with 531 completing the trial. The primary objective was to evaluate the efficacy of HRS9531 injection vs. placebo in reducing body weight after 48 weeks of treatment. Participants were randomized (1:1:1:1) to receive once-weekly subcutaneous injections of HRS9531 2 mg, 4 mg, 6 mg or placebo for 48 weeks.

About HRS9531 (KAI-9531)
HRS9531 is a novel injectable dual GLP-1/GIP receptor agonist developed independently by Hengrui Pharma. It is formulated as an injectable peptide in clinical development for the treatment of type 2 diabetes, obesity and related conditions. Over 2,000 patients to date have been dosed with HRS9531 across several Phase 1, Phase 2, and Phase 3 clinical trials in China. HRS9531 is being developed globally (ex-Greater China) by Kailera Therapeutics as KAI-9531.

About Hengrui Pharma
Hengrui Pharma is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Founded in 1970 with the core principle of putting patients first, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology.

About Kailera Therapeutics
Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity. Kailera’s most advanced program, KAI-9531 (being developed in China as HRS9531), is an injectable dual GLP-1/GIP receptor agonist that has demonstrated positive results in clinical trials in obesity and type 2 diabetes in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery, including oral administration. Kailera’s mission is to develop next-generation weight management therapies that give people the power to transform their lives and elevate their overall health. The Company is based in Waltham, MA and San Diego, CA. For more information, visit www.kailera.com and follow us on LinkedIn and X.

^I Based on the hypothetical strategy estimand (supplementary estimand): treatment effect if the treatment is taken per protocol. Data collected after intercurrent events (ICEs) are excluded from the analysis. ICEs defined in the GEMINI-1 protocol are premature discontinuation of treatment and use of drugs or therapies with a substantial effect on body weight before reaching the primary endpoint.

^II Based on the treatment policy estimand (primary estimand): treatment effect regardless of treatment adherence; Data collected after ICEs are included in the analysis.

References

CONTACT: Contact Information

Contact Information for Hengrui
DGA Group
hengrui@dgagroup.com

Contact Information for Kailera
Maura Gavaghan
Vice President, Corporate Communications and Investor Relations
maura.gavaghan@kailera.com