Stock Markets
The biggest Asian stock markets are trading without a single dynamic
The biggest Asian stock markets showed no unified dynamics on Monday morning, as market participants were watching the situation in the global economy and assessing the statements of Chinese officials during the XX Congress of the Communist Party of China (CPC).
Asian stock markets today — what’s going on?
China’s economy showed signs of “significant improvement” in the third quarter, Zhao Zhenxin, deputy head of the National Development and Reform Commission, said on the sidelines of the congress.
The Chinese economy was negatively affected in March, April and July by unpredictable factors, including external events, coronavirus outbreaks and extreme weather events. MarketWatch quoted the official as saying. Meanwhile, overall business activity, from industrial production and investment to consumer spending, continued to rise, he added.
It also became known on Monday that the People’s Bank of China injected 500 billion yuan ($69.6 billion) into the financial system within the framework of a program of medium-term lending (MLF). At the same time, the rate on one-year MLF loans was kept at 2.75% per annum, the NBK said in a statement.
Earlier, we reported that U.S. stock indices fell by 1.3-3.1%.
Stock Markets
FIRST RESOURCE BANCORP, INC. ANNOUNCES 2024 FIRST QUARTER RESULTS; CONTINUED BALANCE SHEET GROWTH OFFSETS MARGIN COMPRESSION
EXTON, Pa., April 25, 2024 /PRNewswire/ — First Resource Bancorp, Inc. (OTCQX: FRSB), the holding company for First Resource Bank, announced financial results for the three months ended March 31, 2024.
Lauren C. Ranalli, President and CEO, stated, “In a market where many of our peers are reducing lending, we’ve seized the chance to further expand the Bank. Our robust loan growth and disciplined pricing strategies have helped offset rising deposit costs to some extent. Net interest income remained largely steady compared to the previous quarter, despite the ongoing margin compression.”
Highlights for the first quarter of 2024 included:
- Total interest income grew 31% over the prior year
- Net interest income grew 7% over the prior year
- Total loans grew 4% during the first quarter, or 14% annualized
- Total deposits grew 3% during the first quarter, or 11% annualized
- Swap loan referral income totaled $182 thousand during the first quarter, more than double the entire prior year
- There were no non-accrual or non-performing loans as of March 31, 2024
- Book value per share grew 3% to $15.34
Net income for the quarter ended March 31, 2024 was $1.3 million, or $0.43 per common share, compared to $1.6 million, or $0.53 per common share, for the previous quarter and $1.3 million, or $0.41 per common share, for the first quarter of the prior year. Annualized return on average assets was 0.92% for the first quarter of 2024 compared to 1.00% for the first quarter of 2023. Annualized return on average equity was 11.39% for the first quarter of 2024 compared to 12.57% for the same period a year prior.
Total interest income increased quarterly by $200 thousand, or 2%, from $8.2 million for the fourth quarter of 2023 to $8.4 million for the first quarter of 2024. This increase was driven by 4% growth in loans during the first quarter.
Total interest income increased $2.0 million, marking a 31% rise from $6.4 million in the first quarter of 2023 to $8.4 million in the corresponding period of 2024. This increase was driven by a 14% expansion in loans compared to the previous year, complemented by an increased rate environment, favorably affecting interest-earning assets.
Total interest expense increased 7% when comparing the first quarter of 2024 to the fourth quarter of 2023. This increase stemmed from an 8 basis point rise in the cost of money market accounts and a 29 basis point increase in the cost of time deposits, alongside a higher volume of time deposits quarter over quarter. Additionally, interest expense on FHLB borrowings increased by 7% due to a rise in the average balance and cost of advances during the first quarter of 2024 compared to the fourth quarter of 2023.
Total interest expense increased by 82%, climbing from $2.0 million in the first quarter of 2023 to $3.7 million for the first quarter of 2024. The primary driver of this increased expense was a 114 basis point rise in the cost of money market deposits and a 198 basis point increase in the cost of time deposits, coupled with a greater volume of money market accounts and time deposits year over year.
“Rising deposit costs are one of the biggest challenges facing the industry at the moment,” commented Ranalli. “To address this, we’ve allocated substantial internal resources towards optimizing our cost of funds while simultaneously growing our deposit portfolio to support loan growth. Our management team has been bolstered by the addition of an experienced retail banking executive and our lending and deposit teams are collaborating closely, creating synergies via joint calling efforts in the pursuit of new deposit relationships.”
In the first quarter of 2024, net interest income saw a slight decrease of $49 thousand, or 1%, compared to the previous quarter. The net interest margin also contracted by 4 basis points, declining from 3.39% in the fourth quarter of 2023 to 3.35% in the first quarter of 2024. The overall yield on interest-earning assets rose by 13 basis points during the first quarter, primarily driven by a 12 basis point increase in the yield on loans and an expanded loan volume, resulting in a total yield on loans of 6.14% for the first quarter of 2024. Conversely, due to increases in costs for money market and time deposit accounts, alongside a rise in the volume of time deposit accounts, the cost of interest-bearing deposits increased by 20 basis points to 3.45% during the first quarter. Consequently, the total cost of deposits increased by 18 basis points, climbing from 2.59% in the fourth quarter of 2023 to 2.77% in the first quarter of 2024.
The provision for credit losses was $64 thousand in the first quarter of 2024 compared to a negative $263 thousand in the fourth quarter of 2023. The negative reserve observed in the fourth quarter of 2023 was unusual, partly due to specific reserves established as of September 30, 2023, for credits that were resolved during the fourth quarter and became unnecessary as of December 31, 2023. Year over year, the provision for credit losses decreased to $64 thousand in the first quarter of 2024 from $66 thousand in the first quarter of 2023.
As of March 31, 2024, the allowance for credit losses to total loans stood at 0.80%, slightly lower than the 0.81% recorded at December 31, 2023, and lower than the 0.91% reported at March 31, 2023. At both March 31, 2024 and December 31, 2023, there were no non-performing assets.
Non-interest income in the first quarter of 2024 amounted to $396 thousand, a notable increase compared to $208 thousand in the previous quarter and $200 thousand in the first quarter of the prior year. Specifically, swap referral fee income totaled $182 thousand in the first quarter of 2024, compared to none in the fourth and first quarters of 2023.
Non-interest expenses increased $210 thousand, or 7%, in the first quarter of 2024 compared to the prior quarter. Increases in salaries & employee benefits, professional fees, data processing, and other costs were partially offset by decreases in occupancy & equipment and advertising.
Non-interest expenses increased $424 thousand, or 15%, when comparing the first quarter of 2024 to the first quarter of 2023. Non-interest expenses to average assets were 2.28% for the first quarter of 2024 compared to 2.15% for the previous quarter and 2.29% for the first quarter of the prior year.
Deposits increased a net $13.9 million, or 3%, from $499.3 million at December 31, 2023 to $513.2 million at March 31, 2024. During the first quarter, non-interest-bearing deposits increased $1.1 million, or 1%, from $95.4 million at December 31, 2023 to $96.4 million at March 31, 2024. Interest-bearing checking balances decreased $3.3 million, or 8%, from $39.8 million at December 31, 2023 to $36.5 million at March 31, 2024. Money market deposits increased $3.5 million, or 1%, from $231.4 million at December 31, 2023 to $234.9 million at March 31, 2024. Certificates of deposit increased $12.6 million, or 10%, from $132.7 million at December 31, 2023 to $145.4 million at March 31, 2024. Between March 31, 2023 and March 31, 2024, total deposits grew 10%, with strong non-interest-bearing checking, money market, and time deposit growth partially offset by a decline in interest-bearing checking. At March 31, 2024, approximately 81% of total deposits were insured or otherwise collateralized, slightly up from 80% in the prior quarter.
The loan portfolio expanded by $18.6 million, representing a 4% increase, from $531.4 million at December 31, 2023 to $550.0 million at March 31, 2024. While there was robust growth in commercial real estate loans and commercial business loans, this was partially offset by decreases in construction loans and consumer loans when comparing loan balances at December 31, 2023 to loan balances at March 31, 2024. The decrease in construction loans was largely attributed to projects reaching completion and transitioning to permanent financing within the commercial real estate portfolio.
Ranalli added “Commercial real estate loans represent a significant concentration for the Bank which we monitor very closely. This type of lending is a core competency for us and we have the proper risk management tools in place to continuously track this exposure.”
The following table illustrates the composition of the loan portfolio:
Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | |||
Commercial real estate | $ 444,909,373 | $ 413,221,898 | $ 383,875,127 | ||
Commercial construction | 35,337,226 | 48,838,199 | 39,761,445 | ||
Commercial business | 51,780,407 | 50,224,869 | 42,682,372 | ||
Consumer | 17,979,804 | 19,099,155 | 16,793,036 | ||
Total loans | $ 550,006,810 | $ 531,384,121 | $ 483,111,980 |
Investment securities totaled $17.4 million at March 31, 2024 as compared to $25.8 million at December 31, 2023. At March 31, 2024, the held-to-maturity investment portfolio book value was $8.7 million, with a fair market value of $7.7 million, resulting in an unrealized loss of $998 thousand. This unrealized loss, net of tax, of $788 thousand is less than 1.7% of total equity at March 31, 2024. The remainder of the investment portfolio was classified as available for sale with a book value of $10.0 million and a fair value of $8.7 million, resulting in an unrealized loss of $1.3 million. This unrealized loss, net of tax, of $1.1 million is included in accumulated other comprehensive loss on the balance sheet.
Total stockholders’ equity saw a $1.3 million increase, representing a 3% rise, from $46.1 million at December 31, 2023 to $47.5 million at March 31, 2024, primarily due to net income generated. During the quarter ended March 31, 2024, book value per share increased by 43 cents, or 3%, reaching $15.34.
Selected Financial Data: Balance Sheets (unaudited) | |||
March 31, | December 31, | ||
Cash and due from banks | $ 22,314,437 | $ 23,820,615 | |
Time deposits at other banks | 100,000 | 100,000 | |
Investments | 17,382,019 | 25,840,840 | |
Loans | 550,006,810 | 531,384,121 | |
Allowance for credit losses | (4,383,877) | (4,311,306) | |
Premises & equipment | 7,683,039 | 7,639,939 | |
Other assets | 17,923,286 | 18,142,682 | |
Total assets | $ 611,025,714 | $ 602,616,891 | |
Noninterest-bearing deposits | $ 96,439,591 | $ 95,384,366 | |
Interest-bearing checking | 36,493,267 | 39,760,054 | |
Money market | 234,873,774 | 231,407,653 | |
Time deposits | 145,383,468 | 132,738,973 | |
Total deposits | 513,190,100 | 499,291,046 | |
Short term borrowings | 28,000,000 | 35,000,000 | |
Long term borrowings | 9,530,000 | 9,530,000 | |
Subordinated debt | 5,981,258 | 5,978,134 | |
Other liabilities | 6,842,893 | 6,682,220 | |
Total liabilities | 563,544,251 | 556,481,400 | |
Common stock | 3,096,138 | 3,093,414 | |
Surplus | 19,796,666 | 19,767,634 | |
Accumulated other comprehensive loss | (1,055,206) | (1,038,486) | |
Retained earnings | 25,643,865 | 24,312,929 | |
Total stockholders’ equity | 47,481,463 | 46,135,491 | |
Total liabilities & stockholders’ equity | $ 611,025,714 | $ 602,616,891 |
Performance Statistics | |||||
Qtr Ended Mar. 31, 2024 | Qtr Ended Dec. 31, 2023 | Qtr Ended Sep. 30, 2023 | Qtr Ended Jun. 30, 2023 | Qtr Ended Mar. 31, 2023 | |
Net interest margin | 3.35 % | 3.39 % | 3.57 % | 3.64 % | 3.57 % |
Nonperforming loans/ total loans | 0.00 % | 0.00 % | 0.14 % | 0.15 % | 0.16 % |
Nonperforming assets/ total assets | 0.00 % | 0.00 % | 0.13 % | 0.14 % | 0.14 % |
Allowance for credit losses/ total loans | 0.80 % | 0.81 % | 0.88 % | 0.89 % | 0.91 % |
Average loans/average assets | 92.4 % | 91.1 % | 92.2 % | 91.6 % | 91.6 % |
Non-interest expenses/ average assets | 2.28 % | 2.15 % | 2.19 % | 2.29 % | 2.29 % |
Efficiency ratio | 65.5 % | 63.1 % | 60.1 % | 62.5 % | 63.6 % |
Earnings per share “ basic and diluted | $0.43 | $0.53 | $0.51 | $0.47 | $0.41 |
Book value per share | $15.34 | $14.91 | $14.31 | $13.85 | $13.43 |
Total shares outstanding | 3,096,138 | 3,093,414 | 3,090,838 | 3,088,019 | 3,085,576 |
Weighted average shares | 3,094,951 | 3,092,277 | 3,089,441 | 3,086,782 | 3,084,634 |
Annualized |
Per share data for prior periods was restated to reflect the 5% stock dividend paid in June 2023. |
Income Statements (unaudited) | |||||||||
Qtr. Ended Mar. 31, 2024 | Qtr. Ended Dec. 31, 2023 | Qtr. Ended Sep. 30, 2023 | Qtr. Ended Jun. 30, 2023 | Qtr. Ended Mar. 31, 2023 | |||||
INTEREST INCOME | |||||||||
Loans, including fees | $8,228,102 | $7,941,483 | $7,633,163 | $6,923,177 | $6,223,153 | ||||
Securities | 120,713 | 133,125 | 125,882 | 120,133 | 131,350 | ||||
Other | 31,735 | 105,679 | 33,221 | 67,207 | 28,174 | ||||
Total interest income | 8,380,550 | 8,180,287 | 7,792,266 | 7,110,517 | 6,382,677 | ||||
INTEREST EXPENSE | |||||||||
Deposits | 3,519,176 | 3,277,096 | 2,696,301 | 2,267,015 | 1,819,643 | ||||
Borrowings | 105,860 | 98,901 | 195,150 | 64,267 | 126,620 | ||||
Subordinated debt | 93,124 | 93,124 | 93,124 | 93,123 | 93,124 | ||||
Total interest expense | 3,718,160 | 3,469,121 | 2,984,575 | 2,424,405 | 2,039,387 | ||||
Net interest income | 4,662,390 | 4,711,166 | 4,807,691 | 4,686,112 | 4,343,290 | ||||
Provision for credit losses | 63,651 | (263,073) | 71,017 | 20,327 | 66,299 | ||||
Net interest income after provision for credit losses | 4,598,739 | 4,974,239 | 4,736,674 | 4,665,785 | 4,276,991 | ||||
NON-INTEREST INCOME | |||||||||
Service charges and other fees | 100,164 | 94,656 | 109,894 | 107,841 | 99,570 | ||||
BOLI income | 51,356 | 50,730 | 50,237 | 49,281 | 47,691 | ||||
Swap referral fee income | 182,060 | – | 75,649 | – | – | ||||
Other | 62,548 | 62,701 | 61,527 | 55,740 | 53,013 | ||||
Total non-interest income | 396,128 | 208,087 | 297,307 | 212,862 | 200,274 | ||||
NON-INTEREST EXPENSE | |||||||||
Salaries & benefits | 2,045,083 | 1,873,831 | 1,893,558 | 1,844,356 | 1,834,921 | ||||
Occupancy & equipment | 289,202 | 289,361 | 282,025 | 260,284 | 257,741 | ||||
Professional fees | 137,482 | 123,336 | 119,258 | 119,447 | 115,303 | ||||
Advertising | 81,745 | 83,506 | 58,354 | 65,917 | 67,195 | ||||
Data processing | 176,685 | 167,921 | 172,288 | 159,795 | 147,808 | ||||
Other | 584,926 | 567,428 | 543,465 | 611,336 | 468,225 | ||||
Total non-interest expense | 3,315,123 | 3,105,383 | 3,068,948 | 3,061,135 | 2,891,193 | ||||
Income before federal income tax expense | 1,679,744 | 2,076,943 | 1,965,033 | 1,817,512 | 1,586,072 | ||||
Federal income tax expense | 348,807 | 429,920 | 401,490 | 366,371 | 321,784 | ||||
Net income | $1,330,937 | $1,647,023 | $1,563,543 | $1,451,141 | $1,264,288 |
About First Resource Bancorp, Inc.
First Resource Bancorp, Inc. is the holding company of First Resource Bank. First Resource Bank is a locally owned and operated Pennsylvania state-chartered bank with three full-service branches, serving the banking needs of businesses, professionals and individuals in the Delaware Valley. The Bank offers a full range of deposit and credit services with a high level of personalized service. First Resource Bank also offers a broad range of traditional financial services and products, competitively priced and delivered in a responsive manner to small businesses, professionals and residents in the local market. For additional information visit our website at www.firstresourcebank.com. Member FDIC.
This press release contains statements that are not of historical facts and may pertain to future operating results or events or management’s expectations regarding those results or events. These are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934. These forward-looking statements may include, but are not limited to, statements about our plans, objectives, expectations and intentions and other statements contained in this press release that are not historical facts. When used in this press release, the words “expects”, “anticipates”, “intends”, “plans”, “believes”, “seeks”, “estimates”, or words of similar meaning, or future or conditional verbs, such as “will”, “would”, “should”, “could”, or “may” are generally intended to identify forward-looking statements. These forward-looking statements are inherently subject to significant business, economic and competitive uncertainties and contingencies, many of which are either beyond our control or not reasonably capable of predicting at this time. In addition, these forward-looking statements are subject to assumptions with respect to future business strategies and decisions that are subject to change. Actual results may differ materially from the results discussed in these forward-looking statements. Readers of this press release are accordingly cautioned not to place undue reliance on forward-looking statements. First Resource Bank disclaims any intent or obligation to update publicly any of the forward-looking statements herein, whether in response to new information, future events or otherwise.
Stock Markets
Wells Fargo Expands Down Payment Grant Program to Help Bridge Homeownership Ga
$10,000 Homebuyer AccessSM grants now available in additional communities in eight metro areas plus additional eligible areas in N.J.
DES MOINES, Iowa–(BUSINESS WIRE)–Wells Fargo Home Lending announced today the expansion of its $10,000 Homebuyer Access grant program to additional communities in the eight metropolitan areas where the program was launched in 2023. The program also will be expanded to additional eligible areas in New Jersey.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240425796075/en/
We are expanding the availability of our Homebuyer Access grant program to additional areas to provide greater opportunities that empower Black and Hispanic homebuyers, said Kevin Reen, head of Wells Fargo Home Lending. Making these $10,000 grants available in more areas will help increase homeownership opportunities for underserved communities.
Homebuyer Access grants are now available for the first time in all eligible communities in New Jersey. Grants also will be available to homebuyers who are purchasing homes in or who currently live in additional communities in the metropolitan areas where the grant program was launched in 2023:
- Minneapolis“St. Paul“Bloomington, MN-WI
- Philadelphia“Camden“Wilmington, PA-NJ-MD-DE
- Dallas“Ft. Worth“Arlington, TX
- Washington“Arlington“Alexandria, DC-VA-MD-WV
- Baltimore“Columbia“Towson, MD
- Atlanta“Sandy Springs“Alpharetta, GA
- Charlotte“Concord“Gastonia, NC-SC
- New York“Newark“Jersey City, NY-NJ-PA
Homebuyer Access grants are available to homebuyers who earn a combined 120% or less of the area median income in the county where the subject property is located. The grant funds can only be used toward the down payment on a Wells Fargo fixed-rate conventional loan secured by a property that will be the purchaser’s primary residence. Homebuyers who are eligible for the Homebuyer Access grant can combine the grant with many other programs for which they may qualify, including Wells Fargo’s Dream. Plan. Home.SM closing cost credit and/or mortgage. As a result, homebuyers who qualify for both a Homebuyer Access grant and the closing cost credit could receive up to $15,000 from Wells Fargo to help them purchase their home.
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Potential homebuyers looking to purchase a home in any of the areas where the program is available and those who currently live in those areas can find out more about the program, including how to contact a local Wells Fargo Home Lending office in their area, at https://wellsfargo.com/homegrant or they can call 866-327-6414.
The Homebuyer Access grant builds on an SPCP initiative Wells Fargo announced in April 2022. That initial SPCP focused on helping eligible Black and Hispanic homeowners whose mortgages are serviced by Wells Fargo lower their interest rates and reduce their monthly mortgage payments. Through that program, Wells Fargo subsidized the rate and covered one-time expenses”such as non-recurring closing costs or the VA funding fee”associated with the program, and has helped more than 6,000 customers who had not previously taken advantage of the low-rate environment to lower their interest rate.
Beyond the SPCP, the company strives to increase home lending to traditionally underserved communities by removing impediments to homeownership for communities of color and creating a more inclusive housing system. Areas of focus include:
- Investing $100 million to advance racial equity in homeownership, including expanding our strategic partnerships with the National Urban League and UnidosUS to broaden community outreach efforts, providing homebuying readiness and counseling, and working to eliminate systemic obstacles that prevent many Black and Hispanic or Latino customers from achieving their homeownership goals.
- Investing $60 million in Wealth Opportunities Realized Through Homeownership (WORTH) grant funding from 2022 to 2025 through the Wells Fargo Foundation. The grants will open opportunities for 40,000 new homeowners of color through a multi-sector approach focused on reducing gaps in racial and ethnic homeownership and wealth.
- Deploying additional Home Mortgage Consultants in local minority communities. We continue to focus on investing in local staffing, as well as hiring home mortgage consultants who reflect the communities we serve. Hiring is underway in several communities, including Dallas, Philadelphia and New York, where the Homebuyer Access grants will be available.
- Announced an expansion of our Dream. Plan. Home. closing cost credit, which provides borrowers with an income at or below 80% of the area median income where the property is located up to $5,000 to use toward closing costs. The credit is available in 18 metropolitan areas.
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About Wells Fargo
Wells Fargo & Company (NYSE: WFC) is a leading financial services company that has approximately $1.96 trillion in assets. We provide a diversified set of banking, investment and mortgage products and services, as well as consumer and commercial finance, through our four reportable operating segments: Consumer Banking and Lending, Commercial Banking, Corporate and Investment Banking, and Wealth & Investment Management. Wells Fargo ranked No. 47 on Fortune’s 2023 rankings of America’s largest corporations. In the communities we serve, the company focuses its social impact on building a sustainable, inclusive future for all by supporting housing affordability, small business growth, financial health, and a low-carbon economy. News, insights, and perspectives from Wells Fargo are also available at Wells Fargo Stories.
News, insights, and perspectives from Wells Fargo are also available at Wells Fargo Stories.
Additional information may be found at www.wellsfargo.com | Twitter: @WellsFargo
News Release Category: WF- PS
View source version on businesswire.com: https://www.businesswire.com/news/home/20240425796075/en/
Alfredo Padilla, 213-369-6122
alfredo.padilla@wellsfargo.com
Source: Wells Fargo & Company
Stock Markets
Caliway Announced CBL-514 Phase 2 Study for Cellulite Treatment Met All Primary and Secondary Endpoints
- CBL-514 is the first product to treat cellulite at the raised areas.
- Currently, there is no effective and safe cellulite treatment on the market. The global market for cellulite treatment is estimated to expand to $7.37 billion in 2034.
- CBL-0201EFP Phase 2 study demonstrated CBL-514 statistically significant efficacy in reducing cellulite severity scores at 4 and 12 weeks after treatment.
- Over 50% of participants experienced at least one level of improvement in cellulite severity 12 weeks after the final CBL-514 treatment evaluating with the modified Hexsel Cellulite Severity Scale among 4 levels of severity.
- CBL-514 is under development for multiple indications, including Cellulite, Local Fat Reduction (currently in Phase 2b), and Durum’s disease (currently in Phase 2), which brought Caliway the Fast Track Designation and the Orphan Drug Designation by the FDA in Feb. 2024.
NEW TAIPEI CITY, April 25, 2024 /PRNewswire/ — Caliway Biopharmaceuticals (Caliway) today announced the topline results of the CBL-0201EFP Phase 2 study, which met all the primary and secondary efficacy endpoints in the ITT (NYSE:) (Intent-to-treat) and PP (per-protocol) analysis population, demonstrating CBL-514’s statistically and clinically significant efficacy in improving cellulite severity with favorable safety and tolerance profiles.
CBL-514, Caliway’s lead pipeline, is a multi-indication lipolysis injection that can reduce subcutaneous adiposity by inducing adipocyte apoptosis. Among all the current cellulite treatment products, CBL-514 is the first and only product to treat cellulite in the raised areas.
Apart from cellulite treatment, CBL-514 is also under Phase 2 study for subcutaneous fat reduction and Dercum’s disease. Moreover, the U.S. FDA granted CBL-514 Fast Track Designation and Orphan Drug Designation based on the CBL-0201DD Phase 2 study results for Dercum’s disease in February 2024.
CBL-0201EFP Phase 2-stage 1 Topline Results: Significant Reductions in Cellulite Severity Across Three Dosage Groups
CBL-0201EFP Phase 2 study is an open-labeled study to evaluate the safety, tolerability, and efficacy of CBL-514 injection for the treatment of Edematous Fibrosclerotic Panniculopathy (EFP, cellulite). The efficacy was assessed using the modified Hexsel Cellulite Severity Scale (Modified HCSS), with the highest score (9) indicating the most severe cellulite severity and the lowest score (0) indicating no cellulite. The severity level of cellulite will be scored as mild (1-3), moderate (4-6), or severe (7-9), which will be determined by the total scores.
In the CBL-0201EFP Phase 2-stage 1 dose-finding study, a total of 12 participants were enrolled in 3 sequential escalating CBL-514 dose groups, 40mg, 60mg, and 80mg, to receive 1 CBL-514 treatment administered on both sides of the posterolateral thighs.
The statistical analysis revealed significant reductions in cellulite severity across three dosage groups. Follow-up assessments at 2 and 4 weeks post single treatment on both thighs showed statistically significant improvements in cellulite severity for all dosage groups, with the high-dose group of 80 mg showing the most promising efficacy, reducing cellulite severity score (mean ±SD) of -2.0 ±0.9 points (p= 0.00049,95%CI: -2.77, -1.23) and -2.6 ±1.5 (p= 0.00169,95%CI: -3.88, -1.37) at 2 and 4 weeks after treatment.
CBL-0201EFP Phase 2-stage 2 Topline Results: Over 50% of Participants Demonstrated at least One Level of Improvement Among 4 Cellulite Severity Levels
In the CBL-0201EFP Phase 2-stage 2 study is a single-arm study, a total of 23 participants were enrolled to receive up to 2 CBL-514 treatments based on cellulite severity on the thighs, with a maximum single dose not exceeding 320 mg administered at 4-week intervals.
The baseline of participants’ average cellulite severity score (mean ±SD) is 6.5 ± 1.0 points. Four weeks after the final CBL-514 treatment, using Modified HCSS score of 1 ~9 in 4 severity levels, there was a reduction in cellulite severity with a mean change of -1.3 ± 1.3 points (p < 0.00001, 95% CI: -1.70, -0.90), demonstrating CBL-514's statically significant efficacy in cellulite severity improvement at both 4 weeks (p < 0.00001) and 12 weeks (p < 0.00001) after CBL-514 treatment. Moreover, over 50% of participants experienced at least one level of improvement in cellulite severity at the 12 weeks after the final CBL-514 treatment.
In addition to the primary efficacy endpoint, a secondary efficacy endpoint assessed by the Global Aesthetic Improvement Scale (GAIS) demonstrated notable improvements in cellulite. Following the final treatment, both the Principal Investigator (PI) and participants assessed over 95% of individuals as having improved cellulite appearance at the four-week mark.
The safety and tolerability profiles of CBL-514 demonstrated in both stages of the study were favorable and consistent with previous clinical studies of CBL-514. Most adverse events were mild to moderate injection site reactions, including injection site bruising, pain, swelling, and warmth, and were resolved within 28 days post-treatment.
These findings underscore the potential of CBL-514 as a highly effective treatment option for reducing cellulite severity, offering renewed confidence and satisfaction to those affected by this common cosmetic concern.
Following up, Caliway will further develop the cellulite severity scale for future CBL-514 clinical studies to evaluate cellulite improvement efficacy based on the U.S. FDA’s instruction.
About Cellulite (Edematous Fibrosclerotic Panniculopathy, EFP)
Cellulite is characterized by the nonpathological appearance of the dimpled skin surface (likened to orange peel, cottage cheese, or mattress appearance), which occurs on the thighs and buttocks. The relief alterations of cellulite include depressions and raised areas. The depressions are caused by skin retraction by subcutaneous fibrous septa, while raised areas are projections of fat and subcutaneous structures to the skin surface. According to the American Society of Plastic Surgeons (ASPS) report, around 80 to 90% of women experience cellulite dimpling.
The current treatment for cellulite includes non-invasive (medical devices and collagenase drug) and invasive options. However, their efficacy remains limited and temporary. Additionally, most products would cause significant side effects after administration, including severe bruising, pain, and hyperpigmentation, making most patients reluctant to receive them. The clinical need for cellulite treatment remains unmet. The global market for cellulite treatment is estimated to expand to $7.37 billion in 2034.
About the CBL-0201EFP Phase 2 Study
CBL-0201EFP Phase 2 study is an open-labeled study assessing the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite. The study has an integrated design consisting of a single ascending dose (SAD) part in Stage 1 followed by a single-arm design in Stage 2.
The Stage 1 study (clinicaltrial.gov ID: NCT05632926) included a total of 12 participants enrolled in 3 sequential escalating CBL-514 dose groups, 40mg, 60mg, and 80mg. Eligible participants will be sequentially assigned to receive 1 course of allocated CBL-514 dose administered by subcutaneous injection on both sides of the posterolateral thighs.
The Stage 2 study (clinicaltrial.gov ID: NCT05836779) included a total of 23 participants enrolled in 1 selected CBL-514 dose. Eligible participants will be sequentially assigned to receive up to 2 courses of allocated CBL-514 dose administered by subcutaneous injection on both sides of the posterolateral thighs.
About CBL-514
CBL-514, a potentially first-in-class small-molecule drug, is a lipolysis injection that can induce adipocyte apoptosis and lipolysis to reduce subcutaneous adiposity in treatment areas in animal studies without causing any systematic side effects on the central nervous system and cardiovascular system, and respiratory system. Caliway’s preclinical studies showed that CBL-514 upregulates the apoptosis mediators caspase 3 and Bax/Bcl-2 ratio, and then induces dose-dependent adipocyte apoptosis in vivo and in vitro.
Caliway is investigating multiple indications for CBL-514, including non-invasive subcutaneous fat reduction, Dercum’s disease, cellulite, and lipoma treatment.
About Caliway Biopharmaceuticals
Caliway Biopharmaceuticals (Caliway) is a Taiwan-headquartered, clinical-stage biopharmaceutical company driven by the discovery of breakthrough small-molecule therapeutics with a focus on medical aesthetics and inflammatory disease.
Listed on the emerging stock market in Taiwan (TPEX6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: http://www.Caliway.com.tw/en
Disclaimer
This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change.
For additional contact: info@caliway.com.tw
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