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Fractyl Health Presents New Preclinical Data on Sustained Weight Maintenance and Improved Body Composition from its Rejuva ® Single-Administration GLP-1 Pancreatic Gene Therapy in President’s Select
Single administration of Rejuva reduced fat mass and improved glycemia in the well-validated diet-induced obesity (DIO) mouse model
Rejuva also prevented weight and glycemic rebound after semaglutide withdrawal
Data provide first demonstration that Rejuva treatment has potential to mimic natural release of GLP-1 from pancreas
BURLINGTON, Mass., June 23, 2024 (GLOBE NEWSWIRE) — Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today presented new data from its preclinical Rejuva pancreatic gene therapy program in an oral presentation at the American Diabetes Association (ADA)’s 84th Scientific Sessions in Orlando, FL. The presentation titled Single-Dose GLP-1-Based Pancreatic Gene Therapy Durably Maintains Body Composition and Glycemia After Semaglutide Withdrawal in a Murine Model of Obesity, and was chosen as noteworthy and one of eight President’s Select Abstracts at ADA this year.
Rejuva is the Company’s adeno-associated virus (AAV)-based GLP-1 pancreatic gene therapy program (PGTx), designed to enable durable production of GLP-1 in the pancreas for the treatment of obesity and T2D. The study presented at ADA compared the effects of a single dose of Rejuva and daily semaglutide treatment on body composition and glycemic parameters in the well-validated mouse model of diet-induced obesity (DIO). It also examined the effects of single-dose Rejuva in the DIO mice after semaglutide was discontinued.
These data demonstrate that Rejuva can durably improve body composition and fasting glucose, compared to or better than semaglutide, by restoring GLP-1 production in a ˜one-and-done’ treatment, said Harith Rajagopalan, M.D., Ph.D., co-founder and Chief Executive Officer of Fractyl. These data also show Rejuva could help maintain improvements after semaglutide is withdrawn, highlighting our therapy’s potential to fill an emerging and critical need in the management of obesity and T2D: a reliable, ˜off ramp’ from chronic GLP-1 drugs that allows people to maintain the weight loss and blood sugar benefits, even as they stop taking these medicines.
In the study presented at ADA, obese (DIO) mice were randomized 1:1:1 to one of the following and followed for 4 weeks:
- Arm 1: single administration of a Rejuva GLP-1-based gene therapy candidate,
- Arm 2: daily semaglutide injections, or
- Arm 3: placebo
At the end of 4 weeks, semaglutide was discontinued for mice in Arm 2 and those animals were further randomized 1:1 to receive either a single administration of the Rejuva gene therapy candidate or placebo, and all animals were followed for an additional 4 weeks, leading to the following assessment arms at 8 weeks:
- Arm 1: continued follow-up of a single administration of a Rejuva GLP-1-based gene therapy candidate
- Arm 2a: semaglutide withdrawal at week 4
- Arm 2b: semaglutide withdrawal with crossover to single administration Rejuva at week 4
- Arm 3: continued follow up of placebo
At the end of 8 weeks, the pancreatic islets were then isolated to study the effect of glucose exposure on GLP-1-based transgene release from genetically modified islets.
At week 4, the Rejuva arm experienced reduced fat mass of 21% versus 16% of body weight with semaglutide (both p
At week 8, fat mass rebounded to 1% below baseline (n.s.) in the semaglutide withdrawal group (Arm 2a), whereas semaglutide-withdrawn mice treated with Rejuva (Arm 2b) maintained fat reduction of 17% (p
Glucose and insulin levels in all intervention groups corresponded to changes observed in fat mass, with statistically significant improvements in fasting glucose and fasting insulin in semaglutide-treated and Rejuva treated mice at 4 and 8 weeks, but no improvement in glucose or insulin in semaglutide-withdrawn mice that did not crossover to Rejuva at week 8.
In addition to the compelling durability of weight loss, body composition, and glucose improvements seen in this model, we are pleased that isolated, genetically modified islets from Rejuva-treated mice show this release of GLP-1 in response to nutrients, said Timothy Kieffer, Ph.D., Chief Scientific Officer of Fractyl. We believe this clearly demonstrates that Rejuva can mimic the physiologic release of GLP-1 that occurs naturally in the human body.
About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Burlington (NYSE:), MA. For more information, visit‰www.fractyl.com‰or‰https://twitter.com/FractylHealth.
About Rejuva
Fractyl Health’s Rejuva ®‰platform focuses on developing next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies for the treatment of obesity and T2D. The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas. The program aims to transform the management of metabolic diseases by offering novel, disease-modifying therapies that address the underlying root causes of disease.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the promise and potential impact of our preclinical or clinical trial data, the design, initiation, timing and results of clinical enrollment and any clinical trials or readouts, the content, information used for, timing or results of any IND-enabling studies or IND applications, the potential launch or commercialization of any of our product candidates or products, the sufficiency of our cash, cash equivalents, and investments to fund our operating activities for any specific period of time, and our strategic and product development objectives and goals, including with respect to enabling long-term control over obesity and type 2 diabetes without the burden of chronic therapies. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company’s limited operating history; the incurrence of significant net losses and the fact that the Company expects to continue to incur significant net losses for the foreseeable future; the Company’s need for substantial additional financing; the Company’s ability to continue as a going concern; the restrictive and financial covenants in the Company’s credit agreement; the lengthy and unpredictable regulatory approval process for the Company’s product candidates; uncertainty regarding its clinical studies; the fact that the Company’s product candidates may cause serious adverse events or undesirable side effects or have other properties that may cause it to suspend or discontinue clinical studies, delay or prevent regulatory development, prevent their regulatory approval, limit the commercial profile, or result in significant negative consequences; additional time may be required to develop and obtain regulatory approval or certification for the Company’s Rejuva gene therapy candidates; the Company’s reliance on third parties to conduct certain aspects of the Company’s preclinical studies and clinical studies; the Company’s reliance on third parties for the manufacture of the materials for its Rejuva gene therapy platform for preclinical studies and its ongoing clinical studies; the regulatory approval process of the FDA, comparable foreign regulatory authorities and lengthy, time-consuming and inherently unpredictable, and even if we complete the necessary clinical studies, we cannot predict when, or if, we will obtain regulatory approval or certification for any of our product candidates, and any such regulatory approval or certification may be for a more narrow indication than we seek; and the potential launch or commercialization of any of Company’s product candidates or products and our strategic and product development objectives and goals, and the other factors discussed under the caption Risk Factors in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on May 13, 2024 and in our other filings with the SEC. These forward-looking statements are based on management’s current estimates and expectations. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause its views to change.
Contacts‰
Corporate Contact‰
Lisa Davidson, Chief Financial Officer‰
ir@fractyl.com, 781.902.8800
Media Contact‰
Jessica Cotrone, Corporate Communications‰
jcotrone@fractyl.com, 978.760.5622
Investor Contact
Stephen Jasper Gilmartin Group
stephen@gilmartinir.com, 619.949.3681
In a challenging market environment, shares of 374Water (SCWO) have touched a 52-week low, dipping to $0.71. The company, with a market capitalization of $104 million, maintains a strong liquidity position with a current ratio of 3.81 and more cash than debt on its balance sheet, according to InvestingPro data. The company, which specializes in water treatment solutions, has seen its stock price struggle significantly over the past year, reflecting a broader trend in the sector. Investors have been cautious, as evidenced by the stock’s 1-year change, which shows a substantial decline of 52.96%. InvestingPro analysis indicates the stock is currently in oversold territory, with 18 additional investment insights available to subscribers. This downturn highlights the volatility faced by environmental technology companies and raises concerns about future performance amidst uncertain market conditions. With a beta of -0.51, the stock typically moves opposite to market direction, potentially offering diversification benefits.
In other recent news, 374Water Inc. has secured approximately $12.2 million through a registered direct offering, involving the sale of common stock and warrants. The cleantech company expects the gross proceeds before fees and expenses to be around the $12.2 million mark, with D. Boral (OTC:) Capital LLC serving as the exclusive placement agent for the offering. The capital infusion is scheduled to be finalized by November 18, 2024, pending customary closing conditions.
In further developments, 374Water has initiated operations of its AirSCWO technology at the Iron Bridge Regional Water Reclamation Facility in Orlando. This marks a significant step in commercial biosolids processing, with the technology designed to efficiently process biosolids and PFAS contaminated wastes. The successful integration of the AirSCWO system into the Iron Bridge facility demonstrates the company’s capacity to destroy persistent organic pollutants, including PFAS.
The Florida Department of Environmental Protection supported the installation with a grant under the Bilateral Infrastructure Law emerging contaminant funding. Notably, CEO Chris Gannon highlighted the operational success in Orlando as crucial for showcasing the technology’s capacity to manage municipal, federal, and industrial organic waste streams at scale. The company anticipates additional commitments across the United States, including a deployment to Orange County Sanitation (CA) in 2025.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
By Alden Bentley, Samuel Indyk and Rae Wee
NEW YORK/LONDON (Reuters) -Wall Street topped off a global share rally in thin trade on Thursday as markets prepared for early Christmas Eve closes, while the dollar was buoyed by firmer Treasury yields and speculation that the Federal Reserve would slow its easing in 2025.
The was 0.47% higher in late morning trade, the rose 0.73% and the rose 0.99%.
U.S. stock trading wraps up at 1:00 p.m. EDT/1800 GMT, and the bond market closes at 2:00 p.m. Most financial centers around the world are closed on Wednesday for Christmas. The U.S. reopens on Thursday, while many financial centers have a second day off.
“Meagre news and data flow should keep the focus on a more hawkish Fed,” said Ipek Ozkardeskaya, senior analyst at Swissquote Bank.
MSCI’s gauge of stocks across the globe went up more than half a percent. The pan-European index rose 0.18%. 100 rose 0.19% and 40 rose 0.14%. German stocks were closed for the Christmas holiday.
In Asia, Chinese stocks rose after sources told Reuters that Beijing planned to issue a record amount of special treasury bonds next year as it ramps up fiscal stimulus to revive a faltering economy.
The blue-chip index and both ended 1.3% higher. Hong Kong’s advanced 1.1%.
The news came shortly after China’s finance ministry said authorities would ramp up fiscal support for consumption next year by raising pensions and medical insurance subsidies for residents, as well as expanding consumer goods trade-ins.
Still, investors remain cautious on the outlook for the world’s second-largest economy, particularly as it faces the threat of hefty tariffs from U.S. President-elect Donald Trump.
Elsewhere, MSCI’s broadest index of Asia-Pacific shares outside Japan rose 0.37%.
FED FOCUS
Investors are taking direction from last week’s 25 basis point Fed interest rate cut, its signals on the strength of the economy and its slow progress bringing inflation down to its 2% target. Markets are now pricing in about 35 basis points of easing for 2025, implying one quarter-point rate cut and around a 40% chance of a second.
U.S. Treasury yields pared gains after the Treasury saw solid demand for a $70 billion sale of five-year notes, but remained higher on the day. The two-year Treasury yield, which is sensitive to changes in Fed rate expectations, was up 0.9 bp at 4.359%, while the benchmark 10-year yield rose 2.6 bp to 4.625%, reaching a seven-month high at 4.629%. [US/]
“Like markets, the Fed will need to consider U.S. policies on tariffs and immigration in its inflation and growth outlook. We believe the subtle slowing in the U.S. labor market will still be the Fed’s paramount concern,” said analysts at Citi Wealth.
“While always uncertain, our base case expectation for a 3.75% policy rate is unchanged. It’s a far cry from the 1.7% U.S. policy rate average of the past 20 years.”
The Fed’s cut was the third one this cycle, taking the Fed funds rate to 4.25%-4.5%.
Ahead of Trump’s return to the White House in January, global central banks have urged caution over their rate paths due to uncertainty on how his planned tariffs, lower taxes and immigration curbs might affect policy.
Data on Monday showed U.S. consumer confidence unexpectedly weakened in December as the post-election euphoria fizzled and concerns about future business conditions emerged.
In currencies, the rose 0.14% hovering near a two-year high hit Monday, having climbed more than 2% in December so far.
The euro eased 0.15% to $1.0389, while the yen languished near last week’s five-month low, trading at 157.35 per dollar.
Japan’s Finance Minister Katsunobu Kato on Tuesday reiterated Tokyo’s discomfort with excessive foreign exchange moves and put speculators on notice that authorities are ready to act to stabilise a faltering yen.
rose 0.13% to $2,616.26 an ounce, having risen about 27% this year, heading for its biggest yearly gain since 2010.
rose 1.56% to $70.32 a barrel and rose to $73.73 per barrel, up 1.51% on the day. [O/R]
By David French
(Reuters) -Wall Street’s main indexes all ended higher on Tuesday, with gains in megacap and growth stocks bolstering benchmarks in a truncated Christmas Eve session.
Both the and the scored four straight sessions of gains. For the Dow, the run follows its 10-session skid earlier this month, its longest losing streak since 1974.
The benchmarks closed higher on the first day of a historically strong period called the “Santa Claus rally.” The on average has gained 1.3% in the last five days of December and first two days of January, according to data from the Stock Trader’s Almanac going back to 1969.
With megacap stocks having outsized influence on markets, their performance is often a key driver of indexes. When coupled with reduced trading volumes and few other catalysts, as many investors take time off for the holidays, this is even more pronounced.
All the so-called Magnificent Seven megacap technology stocks climbed on Tuesday, led by Tesla (NASDAQ:).
The automaker’s rise helped push consumer discretionary shares higher, making them the top gaining sector in the S&P.
Elsewhere, chip manufacturers were also buoyant. Broadcom (NASDAQ:) and Nvidia (NASDAQ:) were up, while Arm Holdings (NASDAQ:) climbed a day after losses from losing a court case.
Growth names rose despite U.S. Treasury interest rates remaining elevated – the benchmark 10-year note yielded around 4.61% on Tuesday. Traditionally, higher debt costs crimp growth stocks.
However, the long-term themes around technology development, including advancements in artificial intelligence, overshadow any near-term moves in Treasuries, said Charlie Ripley, senior investment strategist for Allianz (ETR:) Investment Management.
“This reinforces that view that the sector is going to remain strong, and should be well into the new year,” he said.
According to preliminary data, the S&P 500 gained 64.93 points, or 1.09%, to end at 6,039.00 points, while the Nasdaq Composite gained 264.31 points, or 1.34%, to 20,029.19. The Dow Jones Industrial Average rose 366.75 points, or 0.85%, to 43,273.70.
Stock markets shut at 1:00 p.m. ET on Tuesday and will be closed for Christmas on Wednesday.
After a stellar run to record highs following the November election, which sparked hopes of pro-business policies under U.S. President-elect Donald Trump, Wall Street’s rally hit a bump this month as investors grappled with the prospect of higher interest rates in 2025.
The U.S. Federal Reserve eased borrowing costs for the third time this year last Wednesday, but signaled only two more 25-basis-point reductions next year, down from its September projection of four cuts, as policymakers weigh the possibility of Trump’s policies stoking inflation.
Allianz’s Ripley said the themes which had driven the market higher in the past two months remained intact, and actions by the Fed had not killed the rally.
“Heading into 2025, things are set up with good positioning,” he said, noting factors including economic outlook, consumption in the U.S. and the labor market.
Crypto-related stocks traded higher on Tuesday, including Microstrategy (NASDAQ:), Riot Platforms (NASDAQ:), and MARA Holdings, as the price of bitcoin advanced.
NeueHealth soared after the healthcare provider said New Enterprise Associates, its largest shareholder, and a group of existing investors will take the company private in a $1.3 billion deal.
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