AI Revolutionizes Non-Bank Mortgage Lending: Insights from HFS Research and Cognizant
New study highlights how 2025 will be a turning point as technology redefines experience, operations, and value across the mortgage lifecycle.
Key Findings:
74% of non-bank lenders are betting on innovation to drive differentiation, while only 21% believe they are leading the pack—revealing a significant gap and opportunity to innovate.
Agentic AI is becoming the next big play, merging GenAI's cognitive reasoning with automation's precision—ushering in task-fulfilling "agents" that scale beyond efficiency into execution.
Only 51% of lenders feel fully prepared for compliance risk, with some receiving up to 1,700 regulatory alerts in 2024—25% with direct business impact.
Demonstrating ROI is critical. Intelligent Document Processing (IDP) is winning over lenders for its fast returns—especially where paper still rules.
Outsourcing is being redefined. Full-service partnerships are expected to rise from 30% to 42% by 2026, measured by growth outcomes instead of simply on cost.
Automation will reach 68% of mortgage operations by 2026, signaling a shift from task-level wins to blending technology, human expertise, and continuous improvement into an intuitive tech-to-ops cycle in mortgage operations.
NEW YORK, May 21, 2025 /PRNewswire/ -- In a rapidly evolving housing economy, non-bank mortgage lenders are facing a wake-up call. A new joint study by HFS Research and Cognizant, "Reinventing the Non-Bank Mortgage Lending Journey in the Age of AI," reveals an industry grappling with operational fatigue, regulatory pressure, and fast-moving tech disruptions—while a small but bold segment rewrites the mortgage playbook.
Drawing insights from 257 non-bank lenders and ecosystem partners, the report delivers a sobering yet hopeful look at the next chapter for mortgage lending. From the emergence of Agentic AI to the reconfiguration of outsourcing strategies, lenders are being challenged to trade reactive cost-cutting for purposeful innovation.
"The fundamentals of lending haven't changed—the loan is still a loan. What's changed is the speed, intelligence, and precision with which it's delivered. This is no longer just about access to capital—it's about how seamlessly, securely, and smartly capital flows through digital channels," says Saurabh Gupta, President, Research and Advisory Services, HFS Research. "The ones who go all-in—building digital-first, modular, and intelligent operations—will define the next era of mortgage lending. The rest? They risk being left behind."
Powerful Data-Driven Insights:
The research reveals that although 2025 is being eyed as a rebuild year, many lenders are stuck playing defense. As lending platforms modernize, access to mortgage capital is becoming faster, smarter, and more modular. Yet, only 21% of lenders consider themselves true innovators. The rest? They're either chasing parity or struggling to catch up.
Compliance is also hitting a breaking point. One executive shared they received over 1,700 regulatory alerts last year—nearly one in four with direct business consequences. The result: compliance is now a 24/7 operation, and tech investment is the only scalable solution.
Divya Iyer, Practice Leader, BFSI, HFS Research, adds, "We're seeing real momentum around Agentic AI—where GenAI meets the execution muscle of automation. But it's not the only force driving change. Technologies like IDP are bridging the gap in paper-heavy workflows, proving that meaningful transformation doesn't have to wait for full digital maturity."
What Lenders Need to Do Next:
Move beyond legacy constraints. 58% of lenders still can't support real-time integration—limiting data agility and delaying decision-making.
Prioritize technology with measurable outcomes. Tools like IDP, AI underwriting, and cybersecurity are driving rapid ROI, while GenAI is expanding into core operations.
Redefine outsourcing partnerships. Lenders must move beyond tactical cost-cutting to leverage partners for platform modernization, AI deployment, and full-service scalability.
Focus on value creation—not just efficiency. The winners will blend automation, data platforms, and talent into a cohesive tech-to-ops cycle.
"In the rapidly evolving landscape of non-bank mortgage lending, there is a critical need for innovation and agility," said Ajay Pandita, Senior Vice President and Financial Services, Fintech and Insurance Business Unit Leader, of Cognizant. "As we navigate through operational fatigue, regulatory pressures, and technological disruptions, it is imperative that we embrace purposeful innovation and redefine our strategies. The emergence of Agentic AI and IDP are just the beginning. By prioritizing technology with measurable outcomes and leveraging full-service partnerships, we can transform the mortgage lending journey and lead the industry into a new era of efficiency and value creation."
Download the full report: Reinventing the Non-Bank Mortgage Lending Journey in the Age of AIReinventing non-bank mortgage lending journey in the age of AI - HFS Research
About HFS ResearchHFS Research is a leading global research and advisory firm that helps Fortune 500 companies navigate IT and business transformation with fearless insights and actionable strategies. With unrivaled access to Global 2000 executives, HFS empowers organizations to make confident technology and service decisions that drive competitive advantage. For more information, visit hfsresearch.com.
About CognizantCognizant (Nasdaq: CTSH) engineers modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we're improving everyday life. See how at www.cognizant.com or @cognizant.
Forward-Looking Statements
This press release includes statements that may constitute forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, the accuracy of which are necessarily subject to risks, uncertainties and assumptions as to future events that may not prove to be accurate. These statements include, but are not limited to, express or implied forward-looking statements relating to the adoption of generative and/or agentic artificial intelligence, the effects of such artificial intelligence on the mortgage lending industry and the competitive opportunities in the marketplace. These statements are neither promises nor guarantees but are the findings of the study discussed above and remain subject to a variety of risks and uncertainties, many of which are beyond Cognizant's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Factors that could cause outcomes to differ materially from those expressed or implied include general economic conditions, the impact of technological development and competition, the competitive and rapidly changing nature of the markets Cognizant and its clients compete in, and the other factors discussed in Cognizant's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Cognizant undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities law.
View original content to download multimedia:https://www.prnewswire.com/news-releases/ai-revolutionizes-non-bank-mortgage-lending-insights-from-hfs-research-and-cognizant-302462014.html
SOURCE HFS Research
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
AXA Launches "Max Goal II Insurance Plan"
Shortest guaranteed breakeven timeframe and market-first Wealth Master Service to empower High-Net-Worth Individuals to secure and grow their wealth across generations HONG KONG, June 4, 2025 /PRNewswire/ -- AXA Hong Kong and Macau ("AXA") has launched the new "Max Goal II Insurance Plan" ("Max Goal II"), featuring the shortest guaranteed breakeven timeframe of 5 years in the market[1] , along with competitive total returns. The plan is complemented by the market-first[2] Wealth Master Service[3], and offers various unique capabilities for wealth distribution and succession. It provides customers with flexible wealth management solutions to achieve long-term assets appreciation and wealth transfer across generations. Janet Lee, Chief Life and Health Insurance Officer of AXA Hong Kong and Macau, said, "Global geopolitical instability has led to market volatility, impacting the stable growth of family assets. In response, we are introducing the new 'Max Goal II Insurance Plan', which offers a 'short guaranteed breakeven timeframe' with ample liquidity for our customers. With highly competitive total returns, this plan empowers customers to achieve steady growth in volatile markets while optimising cash flow management. Furthermore, we recognise the importance of wealth succession planning for High-Net-Worth customers. Therefore, this product features a trust-like wealth inheritance and management structure, along with the market-first Wealth Master Service, allowing customers to allocate their wealth and manage succession planning with flexibility and precision." "Max Goal II" offers the following key features to meet customers' diverse needs across Elevate, Master and Bequeath: 1. Elevate: Guaranteed breakeven timeframe of 5 years Rapid breakeven: The guaranteed cash value at the commencement of the policy equals to 81% of the single premium. By the 5th policy anniversary, the guaranteed cash value will reach 100% of the single premium. Terminal Dividend: Starting from the 3rd policy anniversary, "Max Goal II" offers a non-guaranteed terminal dividend, allowing the policy to achieve total breakeven by the 4th policy anniversary, and further enhancing potential wealth growth and accumulation over the medium to long term. Lock-in gains: From the 5th policy anniversary onwards, customers have the flexibility to exercise the terminal dividend lock-in option[4], converting non-guaranteed dividends into guaranteed returns via the lock-in account and earn interests. Customer can withdraw the value of the terminal dividend lock-in account at any time to meet their financial needs and goals. 2. Master: First ever Wealth Master Service for tailoring wealth distribution Market-first[2] Wealth Master Service[3]: In addition to one-off partial withdrawals, customers can make periodic withdrawals through the Wealth Master Service[3], where they can set the withdrawal amount and period, and nominate up to 3 recipients to receive the withdrawal proceeds, enabling hassle-free allocation of wealth to family and loved ones. Flexi Segregation Option[5]:Customers may split their policies as many times as they want, for optimal family wealth allocation strategically, fulfilling customers' financial needs and goals in different life stages. 3. Bequeath: Seamlessly achieving succession planning, as well as comprehensive wealth inheritance and management structure Heritage Protector Option[6]: Customers can select a succession event option and appoint a contingent owner and interim owner[7] to safeguard the policy and ensure a smooth transition of policy ownership, mitigating inheritance risks. If the succession event occurs before the contingent owner has reached the designated age, the interim owner[7] will hold and manage the policy with granted policy rights pre-specified by the customer before the contingent owner assumes policy ownership after attaining the designated age, ensuring wealth is passed on in accordance with customer's intention. Flexi Continuation Option/Change of insured: Customers may apply to designate one contingent insured[8] and assign a portion of policy value to be accumulated further. In the unfortunate event of the death of the insured, the designated contingent insured will become the new insured, and the pre-assigned portion of the policy value will continue to accumulate for future generations. The remaining portion of the policy will be payable in the form of compassionate benefit in a lump sum to the designated beneficiary. In addition, customer may change the insured of the policy for an unlimited number of times, which will not affect the policy values under the policy, ensuing that the policy value can be passed on to the next generation. Flexi Care Option[9]: Customers can appoint a trusted individual as designated executor. In the unfortunate event of the customers' mental incapacitation or physical incapacitation, this designated executor can act on behalf of the customer to make a one-time withdrawal from the policy, providing crucial emergency financial support. Multiple Death Benefit Settlement Options: Customers may customise different death benefit settlement option for each of the beneficiaries, including lump sum payment, payment by instalments, or hybrid payment based on the diverse needs of beneficiaries, to achieve customers' legacy planning goals. Regardless of the choices made, customers have the flexibility to defer the commencement of settlement of death proceeds with a beneficiary for up to 30 years, aligning the distribution of benefits with the most appropriate timing. Charitable Giving Benefit: Customers can designate a recognised and accredited charity of their choice to receive the charitable giving benefit, of an amount equivalent to 1%[10] of the total standard premiums paid[11], to be paid by AXA when the death benefit becomes payable, ensuring the good deed lasts without affecting the payout of the death benefit. For further details about the Plan, please visit: About AXA Hong Kong and Macau AXA Hong Kong and Macau is a member of the AXA Group, a leading global insurer with presence in 50 markets and serving 95 million customers worldwide. Our purpose is to act for human progress by protecting what matters. As one of the most diversified insurers in Hong Kong, we offer integrated solutions across Life, Health and General Insurance. We are the largest General Insurance provider and a major Health and Employee Benefits provider. Our aim is to not only be the insurer to provide comprehensive protection to our customers, but also a holistic partner to the individuals, businesses and community we serve. At the core of our service commitment is continuous product & service innovation and customer experience enrichment, which is achieved through actively listening to our customers' needs and leveraging and investing in technology and digital transformation. We embrace our responsibility to be a driving force against climate change and a force for good to create shared value for our community. We are proud to be the first to address the importance of mental health through different products and services and thought leading iconic research. Our overall Sustainability Strategy, with emphasis on climate strategy and biodiversity commitment, is developed based on TCFD recommendations. We are committed to integrating environmental, social and governance factors across our business and strive to contribute to a sustainable future through 3 distinct roles - as an investor, an insurer and an exemplary company. THIS PRESS RELEASE IS AVAILABLE ON AXA'S WEBSITE: IMPORTANT LEGAL INFORMATION AND CAUTIONARY STATEMENTS CONCERNING FORWARD-LOOKING STATEMENTSCertain statements contained herein may be forward-looking statements including, but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause AXA's actual results to differ materially from those expressed or implied in the forward-looking statements. Please refer to Part 4 - "Risk factors and risk management" of AXA's Universal Registration Document for the year ended December 31, 2019, for a description of certain important factors, risks and uncertainties that may affect AXA's business, and/or results of operations. AXA undertakes no obligation to publicly update or revise any of these forward-looking statements, whether to reflect new information, future events or circumstances or otherwise, except as part of applicable regulatory or legal obligations. [1] It is compared with similar single premium participating savings plans offering high guaranteed cash value on day one (with guaranteed cash value of 80% or more of the single premium on the policy issuance date) provided by major competitors in the market. The relevant information is as of December 2024. Applicable to policies denominated in US and HK dollars. [2] The information refers to the service of periodic withdrawal with multiple recipients of withdrawal payments. The statement refers to Hong Kong market only and is based on a comparison of periodic withdrawal arrangements offered by insurers for Long-Term Businesses as defined by the Insurance Authority in the Register of Authorised Insurers in Hong Kong as of December 2024. [3] Wealth Master Service is an administrative service arrangement offered by AXA and not a plan feature of "Max Goal II". Any application for the service is subject to the administrative rules of AXA from time to time. [4] Only one application can be made within one policy year. The lock-in rate customer may apply to transfer to the terminal dividend lock-in account in a policy year shall not be more than 10% of the latest value of the terminal dividend before the 15th policy anniversary or 70% of the latest value of the terminal dividend on or after the 15th policy anniversary, customers who wants to transfer to the terminal dividend lock-in account must meet specific conditions. For further details regarding terminal dividend lock-in option, please refer to the policy contract. [5] When customer apply to exercise the Flexi Segregation Option, customer shall specify the percentage (the "Segregation Percentage") of the total cash value customer wish to transfer to the Segregated Policy. An application The designation of contingent insured must fulfil specific conditions. to exercise the Flexi Segregation Option is subject to the approval of the Company at its absolute discretion and must fulfill certain conditions. For further details, please refer to the product brochure. [6] For further details regarding Heritage Protector Option, please refer to the policy contract. [7] Interim owner is only applicable to policies issued in Hong Kong. [8] The designation of contingent insured must fulfil specific conditions. [9] For further details regarding the Flexi Care Option, please refer to the policy contract. [10] 1% of the total standard premiums paid is up to USD 100,000/RMB 650,000/ HKD 800,000. [11] Total standard premiums paid is the total premiums due and paid from the policy date up to the date of death of the insured, in which any extra premiums due to underwriting requirements shall be excluded. In case of any change in notional amount, the total standard premiums paid shall be adjusted accordingly. View original content: SOURCE AXA Hong Kong and Macau Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
an hour ago
- Yahoo
Asia Pacific Enterprise Awards (APEA) 2025 Malaysia Celebrates Future-Ready Enterprises Driving the Nation's Growth
KUALA LUMPUR, Malaysia, June 4, 2025 /PRNewswire/ -- The Asia Pacific Enterprise Awards (APEA) Malaysia concluded its 19th edition with great success, honoring the nation's most future-ready enterprises that are boldly navigating disruption and driving sustainable growth in the new economy. Organized by the region's leading NGO Enterprise Asia, the prestigious awards ceremony was held at Renaissance Kuala Lumpur Hotel & Convention Centre on 30 May 2025. The awards ceremony was graced by the presence of Rizal bin Dato' Nainy, CEO of SME Corp. Malaysia; Mansor Shah Wahid, Deputy CEO of the Malaysia External Trade Development Corporation (MATRADE) (Exporters Development); YBhg. Datuk Wira Dr. Hj. Rais Hussin, CEO of the Malaysian Research Accelerator for Technology and Innovation (MRANTI); along with Dato' Robert Teo, Managing Partner of RSM Malaysia, the event's Official Assurance Partner. Under the theme of "Showcasing Future-Ready Enterprises", the APEA 2025 Malaysia recognized outstanding Malaysian businesses and entrepreneurs who have demonstrated resilience, innovation, and foresight in future-proofing their organizations amidst rapid technological and economic shifts. A distinguished panel of judges meticulously assessed over 100 nominees, evaluating each entrepreneur and organization for their overall excellence, leadership, and business performance. Through this rigorous evaluation process, the most outstanding recipients were selected across four categories: Master Entrepreneur, Inspirational Brand, Fast Enterprise, and Corporate Excellence. Since 2007, the Awards has been organized all over the region with past recipients comprising Taiwan region's Douglas Tong Hsu, Hong Kong SAR's Francis Lui and Lawrence Ho, TTC Vietnam's Dang Van Thanh, Thailand's Supaluck Ampuj, Indonesia's Hary Tanoesoedibjo and Mochtar Riady, India's Adi Godrej, the Philippines' Manuel Villar, and Cuckoo Malaysia's Hoe Kian Choon. "In an era of constant disruption, the enterprises that will thrive are those that challenge conventions, embrace transformative technologies, and create value beyond profits. These organizations recognize the interconnectedness of economies, societies, and the environment, and take bold steps to shape a sustainable and inclusive future." stated Tan Sri Dr. Fong Chan Onn, Chairman of Enterprise Asia, in his inspiring welcome address. Award winners under the Master Entrepreneur category include Chiew Oon Leong, CEO of Cert Academy Sdn Bhd, and Datuk Lawrence Leow Fong Peng, Chief Executive Director of Teamplete Sdn Bhd, who have each demonstrated exceptional leadership, resilience, and vision in steering their organizations to new heights. NS Bluescope Malaysia Sdn Bhd and The Food Purveyor were honored as recipients of the Inspirational Brand Award. Recognized under the Fast Enterprise category is Union Profit Cosmetic Manufacturing Sdn Bhd, while leading companies awarded in the Corporate Excellence category include Niro Ceramic Group, UAC Berhad, and UM Specialist Centre (UMSC). The APEA 2025 Malaysia Chapter is proudly supported by RSM Malaysia as the Official Assurance Partner and PR Newswire as the Official News Release Distribution Partner. Supporting Partners include the Canadian Chamber of Commerce in Malaysia, CCI France Malaysia, EuroCham Malaysia, Kuala Lumpur Malay Chamber of Commerce (KLMCC), and the Malaysian Associated Indian Chambers of Commerce and Industry (MAICCI), with and SME Magazine as the Media Partners. AWARD RECIPIENT LIST OF THE ASIA PACIFIC ENTERPRISE AWARDS 2025 MALAYSIA MASTER ENTREPRENEUR CATEGORY NAME COMPANY INDUSTRY ANDREW TEOW KET SEANG MANAGING DIRECTOR ADVANTAGE MARINE SERVICES (MALAYSIA) SDN. BHD. PROFESSIONAL & BUSINESS SERVICES CHIEW OON LEONG CEO CERT ACADEMY SDN BHD EDUCATION & TRAINING AHMAD RUZAINI BIN ZAINAL MANAGING DIRECTOR KNOWLES ELECTRONICS (M) SDN. BHD. MANUFACTURING DR. SIA TIAN POH CHAIRMAN SIACON TECHNOLOGY SDN BHD CONSTRUCTION DATUK LAWRENCE LEOW FONG PENG CHIEF EXECUTIVE DIRECTOR TEAMPLETE SDN BHD AGRICULTURE FAST ENTERPRISE CATEGORY COMPANY INDUSTRY ADVANTAGE MARINE SERVICES (MALAYSIA) SDN. BHD. PROFESSIONAL & BUSINESS SERVICES ASIC OFFSHORE & MARINE SDN BHD OIL & GAS LEDGEN MALAYSIA SDN BHD PROFESSIONAL & BUSINESS SERVICES NAVIRA MEDITECH SDN. BHD. HEALTHCARE, PHARMACEUTICAL & BIOTECHNOLOGY OPEN DC SDN. BHD. TELECOMMUNICATIONS & ICT SANSICO INDUSTRIES SDN BHD BUILDING MATERIALS SAVOURÉS GROUP SDN BHD INDUSTRIAL & COMMERCIAL PRODUCTS UNION PROFIT COSMETIC MANUFACTURING SDN BHD MANUFACTURING INSPIRATIONAL BRAND CATEGORY COMPANY INDUSTRY NIRO CERAMIC GROUP BUILDING MATERIALS NS BLUESCOPE MALAYSIA SDN BHD BUILDING MATERIALS THE FOOD PURVEYOR RETAIL CORPORATE EXCELLENCE CATEGORY COMPANY INDUSTRY ALWAYS MARKETING PROFESSIONAL & BUSINESS SERVICES COMMERCE DOT COM SDN. BHD. E-COMMERCE EASTERN SUNTECH ENGINEERING & CONSTRUCTION SDN. BHD. CONSTRUCTION EURO HOLDINGS BERHAD FURNITURE NIRO CERAMIC GROUP BUILDING MATERIALS NS BLUESCOPE MALAYSIA SDN BHD BUILDING MATERIALS SIACON TECHNOLOGY SDN BHD CONSTRUCTION TEAMPLETE SDN BHD AGRICULTURE UAC BERHAD MANUFACTURING UM SPECIALIST CENTRE (UMSC) HEALTHCARE, PHARMACEUTICAL & BIOTECHNOLOGY About Enterprise Asia Enterprise Asia is a non-governmental organization in pursuit of creating an Asia that is rich in entrepreneurship as an engine towards sustainable and progressive economic and social development within a world of economic equality. Its two pillars of existence are an investment in people and responsible entrepreneurship. Enterprise Asia works with governments, NGOs, and other organizations to promote competitiveness and entrepreneurial development, uplift the economic status of people across Asia, and ensure a legacy of hope, innovation, and courage for future generations. Please visit for more information. About Asia Pacific Enterprise Awards Launched in 2007, the Asia Pacific Enterprise Awards is the region's most prestigious award for outstanding entrepreneurship, continuous innovation, and sustainable leadership. The Award provides a platform for companies and governments to recognize entrepreneurial excellence, hence spurring greater innovation, fair business practices, and growth in entrepreneurship. As a regional award, it groups together leading entrepreneurs as a powerful voice for entrepreneurship and serves as a by-invitation-only networking powerhouse. The program has grown to encompass 16 countries/ regions and markets all over Asia. For further information, please visit View original content to download multimedia: SOURCE Enterprise Asia Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
2 hours ago
- Yahoo
Ascletis Announces Phase III Trial of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne, Meets All Endpoints
Denifanstat (ASC40), a once-daily oral fatty acid synthase (FASN) inhibitor, demonstrated statistically significant and clinically meaningful improvement compared to placebo in all primary, key secondary, and secondary endpoints Denifanstat demonstrated a favorable safety and tolerability profile Denifanstat was 98% and 178% more effective than U.S. Food and Drug Administration (FDA)-approved sarecycline and doxycycline with regard to placebo-adjusted percent treatment success, respectively, 18.6% for denifanstat versus 9.4% for sarecycline, 18.6% versus 6.7% for doxycycline Denifanstat was 60% more effective than FDA-approved clascoterone cream with regard to placebo-adjusted percent treatment success, 18.6% for denifanstat versus 11.6% for clascoterone cream, respectively The exceptional efficacy of denifanstat coupled with its favorable safety profile in the Phase III trial provides a potential major break-through for the treatment of acne HONG KONG, June 3, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor, meets all primary, key secondary, and secondary endpoints in the Phase III clinical trial for the treatment of moderate to severe acne vulgaris (NCT06192264). The Phase III clinical trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of denifanstat once-daily oral tablet in 480 patients with moderate to severe acne vulgaris. Patients were enrolled and randomized into one active treatment arm and one placebo control arm at the ratio of 1:1 to receive 50 mg denifanstat oral tablet once daily or matching placebo for 12 weeks. Baseline characteristics were well balanced between denifanstat and placebo arms. Table 1 summarizes some of baseline characteristics. Primary, key secondary, and secondary endpoints can be found in Table 2. Primary endpoints included the percent treatment success (defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease in IGA from baseline at week 12), the percent reduction from baseline in total lesion count, and the percent reduction from baseline in inflammatory lesion count. At week 12, percent treatment success was 33.2% compared to 14.6% for placebo, p<0.0001, percent reduction from baseline in total lesion count was 57.4% compared to 35.4% for placebo, p<0.0001, and percent reduction from baseline in inflammatory lesion count was 63.5% compared to 43.2% for placebo, p<0.0001. The key secondary endpoint, percent reduction from baseline in non-inflammatory lesion count at week 12, was 51.9% compared to 28.9% for placebo, p<0.0001. Denifanstat demonstrated a favorable safety and tolerability profile following 12 weeks of once-daily oral administration at 50 mg. The incidence rates of treatment-emergent adverse events (TEAEs) were comparable between denifanstat and placebo. No incidence rates of TEAEs related to study drug in any category exceeded 10%. Only two categories of TEAEs had an incidence rate of more than 5% (6.3% dry skin in denifanstat-treated patients versus 2.9% in the placebo group; 5.9% dry eye in denifanstat-treated patients versus 3.8% in the placebo group). All denifanstat-related adverse events (AEs) were mild or moderate. There were no denifanstat-related grade 3 or 4 AEs and no denifanstat-related serious AEs (SAEs). No deaths were reported. The mechanisms of action of denifanstat for the treatment of acne are (1) direct inhibition of facial sebum production, through inhibition of de novo lipogenesis (DNL) in human sebocytes; and (2) inhibition of inflammation, through decreasing cytokine secretion and Th17 differentiation. Denifanstat's unique mechanism of action directly reduces one of the main underlying causes of acne which is the overproduction of sebum. This makes denifanstat unique as most other acne treatments do not treat the underlying cause of the condition. "We are extremely pleased with the topline results of our Phase III trial. Denifanstat tablets demonstrated impressive efficacy beyond treatment success, showing significant reductions in total lesion count, inflammatory lesion count, and non-inflammatory lesion count. We are excited to be submitting this innovative treatment with the China National Medical Products Administration (NMPA) soon." said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. Table 3 highlights the excellent efficacy of denifanstat in a non-head-to-head comparison to other commonly used oral and topical acne treatments. Denifanstat demonstrated its exceptional efficacy across multiple key metrics compared to sarecycline, doxycycline and clascoterone cream. With regard to the placebo-adjusted percent treatment success and the placebo-adjusted percent reduction from baseline in inflammatory lesion count, denifanstat was 98% and 30% more effective than sarecycline, respectively, 178% and 178% more effective than doxycycline, respectively, and 60% and 59% more effective than clascoterone cream, respectively. With regard to the placebo-adjusted percent reduction from baseline in total lesion count, denifanstat was 189% and 85% more effective than doxycycline and clascoterone cream, respectively. With regard to the placebo-adjusted percent reduction from baseline in non-inflammatory lesion count, denifanstat was 411% and 102% more effective than sarecycline and clascoterone cream, respectively. Denifanstat has the potential to be a first-in-class, once-daily, oral acne therapeutic, potentially offering both exceptional efficacy and patient compliance with a favorable safety and tolerability profile. Compared to other oral acne treatments, denifanstat provides outstanding efficacy with excellent safety. There is no potential for antibiotic resistance or off target effects which can occur with tetracycline derivatives and no reported denifanstat-related severe AEs such as hepatotoxicity, hearing impairment and depression which are seen with isotretinoin. Denifanstat should also provide better adherence to treatment compared to topical therapies: an estimated 30% to 40% of patients do not adhere to their topical treatments[1]. Denifanstat is licensed from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China. "The Phase III clinical trial results for denifanstat are highly encouraging. The data demonstrate statistically significant improvements in treatment outcomes for moderate-to-severe acne patients, with percent treatment success of 33.2%, total lesion count reduction of 57.4% from baseline, inflammatory and non-inflammatory lesion counts decreasing by 63.5% and 51.9%, respectively, while maintaining a favorable safety and tolerability profile. Denifanstat's first-in-class mechanism targeting FASN directly addresses a key cause for acne, establishing it as a groundbreaking therapeutic approach in acne treatment." said Prof. Leihong Xiang, Chief Physician of Dermatological Department, Huashan Hospital, Fudan University, Executive Deputy Director of Institute of Dermatology, Fudan University, Deputy Director of Dermatology Division of Chinese Medical Doctor Association and principal investigator of denifanstat Phase III trial for moderate to severe acne. [1] Purvis CG, Balogh EA, Feldman SR. Clascoterone: How the Novel Androgen Receptor Inhibitor Fits Into the Acne Treatment Paradigm. Ann Pharmacother. 2021;55(10):1297-1299. doi:10.1177/1060028021992055. Table 1. Baseline characteristics of Phase III trial of denifanstat Baseline characteristics 50 mg denifanstat, oral, oncedaily (n=240) Placebo, oral, once daily (n=240) Total lesion count 102.2 102.1 Inflammatory lesion count 42.1 43.1 IGA=3 (moderate), % 85.8 85.8 IGA=4 (severe), % 14.2 14.2 Table 2. Efficacy endpoints of 50 mg denifanstat oral, once daily at week 12 versus placebo (intent-to-treat, ITT, analysis) Efficacy endpoints (1) 50 mg denifanstat, oral, once daily (n=240) Placebo, oral,once daily (n=240) Placebo adjusted p value Percent treatment success (2) (primary endpoint) 33.2 14.6 18.6 <0.0001 Percent reduction from baseline in total lesion count (primary endpoint) 57.4 35.4 22.0 <0.0001 Percent reduction from baseline ininflammatory lesion count (primary endpoint) 63.5 43.2 20.3 <0.0001 Percent reduction from baseline in non-inflammatory lesion count (key secondary endpoint) 51.9 28.9 23.0 <0.0001 Absolute reduction from baseline intotal lesion count (secondary endpoint) 58.3 36.2 22.1 <0.0001 Absolute reduction from baseline in inflammatory lesion count (secondaryendpoint) 26.6 18.4 8.2 <0.0001 Notes: (1) All efficacy endpoints are least square means.(2) Treatment success is defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease in IGA from baseline at week 12. Table 3. Denifanstat compared to other commonly used acne treatments (not head-to-head comparison) Category Denifanstat (n=240) Sarecycline(1) (n=1002) Doxycycline(2) (n=216) Clascoterone cream(3) (n=722) Baseline characteristics Total lesion count 102.2 72.4 71.7 103.6 Inflammatory lesion count 42.1 30.0 33.6 42.7 IGA=3 (moderate), % 85.8 85.2 93.5 82.7 IGA=4 (severe), % 14.2 14.9 6.5 17.3 Efficacy endpoints at week 12 Placebo-adjusted percenttreatment success 18.6 9.4 6.7 11.6 Placebo-adjusted percent reductionfrom baseline in total lesion count 22.0 NA 7.6 11.9 Placebo-adjusted percent reductionfrom baseline in inflammatorylesion count 20.3 15.6 7.3 12.8 Placebo-adjusted percent reduction from baseline in non-inflammatorylesion count 23.0 4.5 NA 11.4 Notes: (1) The sarecycline data represent an analysis of its two Phase III clinical trials, with values expressed as means. The data are from Moore, A., et al., J Drugs Dermatol 2018 Vol. 17 Issue 9 Pages 987-996. The non- inflammatory lesion count data are from FDA ( The doxycycline data at week 16 are from Moore, A., et al., J Drugs Dermatol 2015 Vol. 14 Issue 6 Pages 581-6.(3) The clascoterone cream (1%) data represent an analysis of its two Phase III clinical trials, with values expressed as means. The data are from Hebert. A, et al., JAMA Dermatology 2020 Vol. 156 Issue 6, DOI: 10.1001/jamadermatol.2020.0465. About Ascletis Pharma Inc. Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange ( covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on metabolic diseases by addressing unmet medical needs from a global perspective. Ascletis has multiple clinical stage drug candidates in its metabolic disease pipeline. For more information, please visit Contact: Peter VozzoICR Healthcare443-231-0505 (U.S.) Ascletis Pharma Inc. PR and IR teams+86-181-0650-9129 (China)pr@ ir@ View original content: SOURCE Ascletis Pharma Inc. Sign in to access your portfolio
