Curis Inc (CRIS) Q3 2025 Earnings Call Highlights

 

Positive Points

• Curis Inc (NASDAQ:CRIS) is making steady progress in their Take Aim Lymphoma study, which could support accelerated submissions in the US and Europe.

• The company is exploring the potential of emusertib to change the treatment paradigm for CLL patients, aiming for deeper responses and improved quality of life.

• Initial data from the AML triplet study shows promising MRD conversion rates, with no disease progression observed among patients.

• Curis Inc (NASDAQ:CRIS) reported a reduced net loss for Q3 2025 compared to the same period in 2024, indicating improved financial management.

• The company has sufficient cash and cash equivalents to fund operations into 2026, providing a stable financial outlook.

Negative Points

• Curis Inc (NASDAQ:CRIS) continues to operate at a net loss, with $7.7 million reported for Q3 2025.

• Research and development expenses, although reduced, still represent a significant cost, impacting overall financial performance.

• The company anticipates the need to raise additional capital before the end of the year, indicating potential financial constraints.

• There are dose-limiting toxicities observed in the AML triplet study, which could impact the study's progression and outcomes.

• The success of ongoing studies is contingent on regulatory approvals and successful patient enrollment, which carry inherent risks and uncertainties.

Q: Can you provide details on the FDA discussions and the protocol submitted for the CLL program? A: (Jim Denser, CEO) We are excited about the CLL study, which addresses unmet medical needs by combining emusertib with a BTK inhibitor for patients who have only achieved a partial response. (Dr. Ahmed Hamdi, Chief Medical Officer) We are aligned with the FDA and plan a dose escalation study starting at 100 mg, expanding to 200 mg in phase two.

Q: Could you discuss the size of the phase two CLL trial and resource prioritization? A: (Jim Denser, CEO) The CLL study is designed for 40 patients, aiming to demonstrate deeper responses by blocking both pathways driving the disease. (Dr. Ahmed Hamdi, Chief Medical Officer) Achieving a complete response rate above 20% would be exciting. (Diana Duval, CFO) Our priorities include continuing the PCNSL trial and launching the CLL trial, with plans to secure additional capital by year-end.

Q: What are the safety considerations for the CLL study, particularly regarding potential adverse events? A: (Jim Denser, CEO) We are monitoring for any drug-drug interactions with BTK inhibitors. (Dr. Ahmed Hamdi, Chief Medical Officer) We have tested emusertib with ibrutinib in NHL patients without seeing additive toxicities, and we expect similar results with other BTK inhibitors.

Q: What should investors expect from the upcoming Snow conference? A: (Jim Denser, CEO) We will present several posters, including updates on PCNSL and secondary CNS lymphoma studies. Expect to learn more about our progress over the last six months and new findings in secondary CNS lymphoma.

Q: How is Curis managing its financial resources given the ongoing trials? A: (Diana Duval, CFO) We are focused on continuing our PCNSL and CLL trials and plan to raise additional capital before the end of the year to support these initiatives.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

https://finance.yahoo.com/news/curis-inc-cris-q3-2025-050229378.html

Gilead (GILD) Promising Long-term Data on Livdelzi for PBC

 Gilead Sciences, Inc. (NASDAQ:GILD) presented new long-term data reinforcing the safety and efficacy profile of Livdelzi (seladelpar) for primary biliary cholangitis (PBC) at The Liver Meeting hosted by the American Association for the Study of Liver Diseases in Washington, D.C. The biotech giant, with a market capitalization of $153.26 billion, has seen its shares climb 36.43% year-to-date, currently trading near its 52-week high of $124.61. 

Real-world data from 396 patients showed Livdelzi’s effectiveness as an alternative for those switching from obeticholic acid and as a second-line therapy. Among the patients analyzed, 130 switched from obeticholic acid while 266 used Livdelzi as second-line or monotherapy. Reductions in alkaline phosphatase (ALP) were observed in both groups, with most patients achieving ALP levels below 1.67×ULN. Safety labs remained stable, and 93% of patients continued Livdelzi treatment throughout the observation period.

https://ca.investing.com/news/company-news/gilead-reports-longterm-data-supporting-livdelzi-for-pbc-patients-93CH-4301053

West Pharmaceutical launches solution for injectable biologics

 

West Pharmaceutical Services, Inc. has continued to reaffirm its leadership in injectable drug delivery through the launch of the fully verified PFS System, designed to address the market's evolving needs. In addition, robust demand for proprietary products and high-value components continues to drive growth momentum

West Pharmaceutical was founded in 1923 and is headquartered in Exton, Pennsylvania. The company specializes in the design and manufacture of packaging components and delivery systems for injectable drugs and other healthcare products. The company operates in two segments: Proprietary Products and Contract-Manufactured Products. Geographically, it is segmented into Europe, Middle East, Africa, Americas and Asia Pacific.

Injectable innovation unveiled

West Pharmaceutical launched the West Synchrony™ Prefillable Syringe (PFS) System at CPHI Worldwide. This system provides a fully verified, system-level solution that streamlines syringe selection and accelerates regulatory submissions for pharmaceutical companies. This launch positions the company to capture demand for integrated and regulatory-ready drug delivery systems amid the rise of injectable biologics, enhancing its differentiation and growth prospects in the injectables market.

Improved gearing ratio

West Pharmaceutical demonstrated decent performance over FY 21-24, with a revenue CAGR of 0.7%, reaching $2.9bn in FY 24. This growth was driven by increasing demand for injectable drug delivery systems and better biologics market penetration. Meanwhile, EBIT registered a CAGR of -8.3%, reaching $594.0m, while its margin declined by 646bp to 20.5%.

Over FY 21-24, CFO rose from $584.0m to $653.0m. Its total debt declined from $325m to $305m. Consequently, the company's gearing improved from 13.9% to 11.4%.

Over Q3 25, the company posted decent topline growth, fueled by the strong performance of the Proprietary Products segment, supported by rising demand for GLP-1, self-injection devices, and High-Value components. However, EBIT margins contracted by 47bp to 21.9%.

In comparison, ICU Medical, Inc., a local peer, reported a revenue CAGR of 21.9% over FY 21-24, reaching $2.4bn in FY 24. EBIT declined at a CAGR of -11.7% to $97.4m. Its margin therefore contracted from 10.7% to 4.1%.

Optimistic outlook

The company is currently trading at an EV/EBIT of 31.7x, based on the FY 25 estimated EBIT of $609.9m, which is lower than its 3-year historical average of 33.2x but higher than that of ICU Medical, which is trading at 14.2x.

However, the stock has underperformed due to weak guidance and margin pressures; West Pharmaceuticals is well positioned to benefit from the high-growth GLP-1 drug market. The company paid an annual dividend of $0.8 in FY 24, resulting in a dividend yield of 0.3%.

The stock is monitored by 15 analysts with 12 having 'Buy' ratings and 3 having 'Hold' ratings for a target price of $350.8, implying 27.4% upside potential from the share's current market price.

Looking ahead, analysts project a revenue CAGR of 6.5% for FY 24-27, reaching $3.5bn in FY 27. EBIT is expected to rise at a CAGR of 10.0%, reaching $762.8m, with a margin of 21.8%. Net income is projected to rise at a CAGR of 8.7%, reaching $632.3m. In comparison, ICU Medical's EBIT is expected to increase at a slightly lower CAGR of 9.1% over FY 24-27.

Overall, West Pharmaceutical has posted a steady performance, highlighted by modest growth and improved financial discipline. Looking ahead, the company's expanding biologics portfolio and innovation-led strategy positions it for sustained growth with margin upliftment. However, the company faces risks from supply chain interruptions and regulatory reforms, which may jeopardize compliance and impair efficiency across its global production.

https://www.marketscreener.com/news/west-pharmaceutical-launches-solution-for-injectable-biologics-ce7d5fdad98bf223

Airlines rebook majority of 12,000 affected passengers

 American Airlines said Friday it managed to rebook most of the 12,000 passengers affected by flight cancellations following an FAA order amid the government shutdown, The Washington Post reported. The carrier reduced departures on high-frequency routes to limit disruptions, cutting Boston–Reagan National flights from 10 to 9 daily, Dallas–San Antonio from 11 to 10, and Dallas–Northwest Arkansas from 10 to 8. In total, 220 flights were canceled on Friday.

Additionally, United Airlines also said over 80% of impacted passengers were rebooked, with most expected to reach their destinations within four hours of their original plans. Both carriers concentrated cancellations on smaller regional routes, helping minimize travel delays and maintain aircraft and crew schedules at major hubs.

https://breakingthenews.net/Article/Airlines-rebook-majority-of-12000-affected-passengers/65146664

US household debt hits a new record: NY Fed

 American households' debt burdens increased to the highest level on record in the third quarter of 2025, according to a new report by the Federal Reserve Bank of New York.

The New York Fed's Center for Microeconomic Data released its quarterly report on household debt and credit this week, which showed that household debt rose by $197 billion in the third quarter to a record of $18.59 trillion.

Mortgage balances grew by $137 billion in the quarter to a total of $13.07 trillion at the end of September, while credit card balances rose $24 billion to a total of $1.23 trillion at the end of the quarter. Auto loan balances were steady at $1.66 trillion, while student loan balances increased $15 billion to a total of $1.65 trillion.

"Household debt balances are growing at a moderate pace, with delinquency rates stabilizing," said Donghoon Lee, economic research advisor at the New York Fed. "The relatively low mortgage delinquency rates reflect the housing market's resilience, driven by ample home equity and tight underwriting standards."

Overall delinquency rates remained elevated in the third quarter of 2025, with 4.5% of outstanding debt in some stage of delinquency. 

The New York Fed noted that transitions into early delinquency were mixed with credit card debt and student loans increasing, while all other debt types saw decreases. 

Transitions into serious delinquencies, defined as 90 days or more delinquent, were largely stable for auto loans, credit cards and mortgages. Overall debt flow into serious delinquency was 3.03% in the third quarter of 2025, up from 1.68% in the same quarter last year.

Missed payments on federal student loans weren't reported to credit bureaus from the second quarter of 2020 to the four quarter of 2024, and the resumption of those reports caused student delinquencies to rise sharply in the first half of 2025.

The New York Fed found that in the third quarter of 2025, 9.4% of aggregate student debt was reported as 90+ days delinquent or in default, compared with 7.8% in the first quarter and 10.2% in the second quarter.

The Federal Reserve cut interest rates for the second consecutive meeting in October despite elevated inflation amid signs of a weakening labor market. 

Policymakers have cautioned that while economic growth has been solid overall, there are signs it's being driven by higher income consumers while less affluent households are struggling.

Federal Reserve Chairman Jerome Powell said at his press conference following the rate cut decision that there is a "bifurcated economy" and that "consumers at the lower end are struggling and buying less and shifting to lower-cost products, but that at the top, people are spending at the higher end of income and wealth."

https://www.foxbusiness.com/economy/us-household-debt-hits-new-record-ny-fed-finds