Latest news with #Revita
Yahoo
26-05-2025
- Health
- Yahoo
HairSmart Voted #1 Post-Transplant Shampoo by Real Users in 2025 Consumer Survey
CLEVELAND, May 26, 2025 (GLOBE NEWSWIRE) -- In a comprehensive customer feedback survey conducted in Q1 2025, HairSmart Root Scalp Hair Therapy Shampoo has been voted the #1 shampoo for post-hair transplant care by over 600 verified users across the U.S., outperforming leading competitors like Nioxin, Revita, and Pura D'or. The survey, commissioned by an independent consumer insights firm, found that 92% of respondents reported increased scalp comfort and reduced irritation after switching to HairSmart, while 91% confirmed the shampoo met their key post-transplant needs, including gentle cleansing, soothing ingredients, and support for healthy hair regrowth. Why HairSmart Stands Out Hair transplant patients face a critical healing phase where scalp sensitivity and hair follicle strength are paramount. Survey respondents repeatedly praised HairSmart's: Sulfate & Paraben-Free Formula: Safe for delicate, healing skin Ayurvedic Blend of Anantmool, Amla, Ginger, and Neem: Reduces inflammation and promotes follicle health Balanced Scalp pH: Supports a clean, non-irritated environment for hair growth Clinically-Informed and Patient-Recommended: Trusted by transplant recipients and clinics alike Video Link One user shared, "HairSmart was the only shampoo gentle enough for my healing scalp. It soothed irritation and helped my new hair grow stronger." Survey Highlights Participants, all within 3 weeks to 12 months post-transplant, rated shampoos on scalp irritation, hair texture, shedding, and overall satisfaction. HairSmart led the pack: Rank Shampoo Highly Satisfied Users 1 HairSmart Root Scalp Therapy 94% 2 Revita Hair Stimulating Shampoo 72% 3 Pura D'or Anti-Thinning 68% - Nioxin Cleanser 51% Moreover, 76% of respondents noted their hair transplant specialist recommended plant-based or Ayurvedic shampoos, validating HairSmart's formulation approach. Prerna Video Link Real User Testimonials 'After my transplant, my scalp was very itchy and dry. Switching to HairSmart brought relief within days. My hair feels stronger and healthier now.' – Michael R., Los Angeles 'I tried several shampoos, but HairSmart was the only one my dermatologist approved for post-transplant care. It really made a difference.' – Sarah T., New York To learn more about how often to wash your hair, read more. The Ayurvedic Advantage HairSmart's carefully selected ingredients harness centuries-old wisdom alongside modern research: Anantmool: Calms inflammation and detoxifies the scalp Amla: Strengthens hair roots and boosts collagen Ginger: Enhances blood circulation and fights microbes Neem: Naturally controls dandruff and itching This unique formula meets the growing consumer demand for clean, effective, and traditional hair care solutions. Read the top 10 shampoos for hair growth! About HairSmart HairSmart is a leader in drug-free, plant-based hair care, offering clinically tested products designed for sensitive scalps and hair loss recovery. The Root Scalp Hair Therapy Shampoo exemplifies their commitment to blending natural science with wellness. For the full survey report and more details on HairSmart products, visit Press Contact:Manish GupraChief Marketing Officer, HairSmart manishg@ +91 8802821783 Videos accompanying this announcement are available at in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
26-05-2025
- Health
- Yahoo
HairSmart Voted #1 Post-Transplant Shampoo by Real Users in 2025 Consumer Survey
CLEVELAND, May 26, 2025 (GLOBE NEWSWIRE) -- In a comprehensive customer feedback survey conducted in Q1 2025, HairSmart Root Scalp Hair Therapy Shampoo has been voted the #1 shampoo for post-hair transplant care by over 600 verified users across the U.S., outperforming leading competitors like Nioxin, Revita, and Pura D'or. The survey, commissioned by an independent consumer insights firm, found that 92% of respondents reported increased scalp comfort and reduced irritation after switching to HairSmart, while 91% confirmed the shampoo met their key post-transplant needs, including gentle cleansing, soothing ingredients, and support for healthy hair regrowth. Why HairSmart Stands Out Hair transplant patients face a critical healing phase where scalp sensitivity and hair follicle strength are paramount. Survey respondents repeatedly praised HairSmart's: Sulfate & Paraben-Free Formula: Safe for delicate, healing skin Ayurvedic Blend of Anantmool, Amla, Ginger, and Neem: Reduces inflammation and promotes follicle health Balanced Scalp pH: Supports a clean, non-irritated environment for hair growth Clinically-Informed and Patient-Recommended: Trusted by transplant recipients and clinics alike Video Link One user shared, "HairSmart was the only shampoo gentle enough for my healing scalp. It soothed irritation and helped my new hair grow stronger." Survey Highlights Participants, all within 3 weeks to 12 months post-transplant, rated shampoos on scalp irritation, hair texture, shedding, and overall satisfaction. HairSmart led the pack: Rank Shampoo Highly Satisfied Users 1 HairSmart Root Scalp Therapy 94% 2 Revita Hair Stimulating Shampoo 72% 3 Pura D'or Anti-Thinning 68% - Nioxin Cleanser 51% Moreover, 76% of respondents noted their hair transplant specialist recommended plant-based or Ayurvedic shampoos, validating HairSmart's formulation approach. Prerna Video Link Real User Testimonials 'After my transplant, my scalp was very itchy and dry. Switching to HairSmart brought relief within days. My hair feels stronger and healthier now.' – Michael R., Los Angeles 'I tried several shampoos, but HairSmart was the only one my dermatologist approved for post-transplant care. It really made a difference.' – Sarah T., New York To learn more about how often to wash your hair, read more. The Ayurvedic Advantage HairSmart's carefully selected ingredients harness centuries-old wisdom alongside modern research: Anantmool: Calms inflammation and detoxifies the scalp Amla: Strengthens hair roots and boosts collagen Ginger: Enhances blood circulation and fights microbes Neem: Naturally controls dandruff and itching This unique formula meets the growing consumer demand for clean, effective, and traditional hair care solutions. Read the top 10 shampoos for hair growth! About HairSmart HairSmart is a leader in drug-free, plant-based hair care, offering clinically tested products designed for sensitive scalps and hair loss recovery. The Root Scalp Hair Therapy Shampoo exemplifies their commitment to blending natural science with wellness. For the full survey report and more details on HairSmart products, visit Press Contact:Manish GupraChief Marketing Officer, HairSmart manishg@ +91 8802821783 Videos accompanying this announcement are available at 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
04-04-2025
- Business
- Yahoo
Fractyl Health, Inc. (GUTS): Insider Were Buying In Q1 2025
We recently published a list of . In this article, we are going to take a look at where Fractyl Health, Inc. (NASDAQ:GUTS) stands against other micro-cap stocks insiders were buying in Q1 2025. The White House announced Tuesday that Trump's tariffs would take effect immediately after being unveiled on Wednesday. In anticipation of these 'reciprocal tariffs,' which will apply to all countries, the stock market reacted. By Tuesday morning, the broader market index and Nasdaq Composite dropped by about 0.2%, while blue-chip companies lost 0.06%. Amid ongoing market uncertainty, insider trading often comes under the spotlight. Executive stock purchases can signal optimism, but sales may reflect personal financial decisions or a need to diversify investments. To maintain transparency, executives typically follow pre-arranged strategies, like 10b5-1 plans. While insider trading can offer valuable information, it's important to evaluate it in the broader context of the company's financial stability and current market trends. Today, we're focusing on stocks with micro market capitalizations that have seen significant insider buying in the first quarter of the year. Using Insider Monkey's insider trading screener, we identified companies with market caps under $250 million where at least three insiders purchased shares in the past three months. From this list, we ranked the top 10 stocks with the highest number of insiders making purchases. Stocks that have been recently covered were excluded from our analysis. Our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds, focusing on insider trading and stock picks from hedge fund investor newsletters and conferences. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (). With each stock, we note the number of insiders who acquired shares in the first quarter and market capitalizations. A biologist in a lab coat studying a culture of cells to find a cure for metabolic disorders. Number of insiders buying: 5 Market Capitalization: $54.30 million Fractyl Health is a metabolic therapeutics company focused on developing treatments for type 2 diabetes (T2D) and obesity. It is developing the Revita DMR System, a procedure targeting duodenal dysfunction, and Rejuva, a gene therapy platform aimed at long-term remission of T2D by altering metabolic hormone function in the pancreas. In January, the company announced a strategic decision to focus Revita exclusively on weight maintenance, prioritizing the REMAIN-1 pivotal study to address the most pressing need in obesity care, while advancing its novel Rejuva gene therapy platform into first-in-human studies. Fractyl paused investment in its Revita programs for T2D, which consisted of the REVITALIZE-1 study, and the Germany Real-World Registry study. In March, the company announced positive early data from its REVEAL-1 cohort in the REMAIN-1 pivotal study, suggesting that Revita may help prevent weight regain after stopping GLP-1 drugs. This addresses an unmet need in obesity treatment as the demand for scalable, non-pharmacologic solutions grows with increasing GLP-1 discontinuation rates. During the first quarter, five insiders acquired approximately $193,475 worth of Fractyl Health shares at an average price of $1.24 per share. Currently, the stock trades at $1.11 per share, having declined 46.12% year-to-date and 83.53% over the past 12 months. Net loss amounted to $68.69 million, compared to net loss of $77.09 million in 2023. For the full year 2024, Fractyl Health reported revenue of $93,000, compared to $120,000 in 2023. Gross profit was $43,000, flat compared to the previous year. Based on two Wall Street analysts' estimates, Fractyl Health stock is a 'Moderate Buy' with a price target of $8.00. The average price target suggests a 620.72% potential upside from the latest price. Overall, GUTS ranks 8th on our list of micro-cap stocks insiders were buying in Q1 2025. While we acknowledge the potential of GUTS our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns, and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than GUTS but that trades at less than 5 times its earnings, check out our report about the . READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
01-04-2025
- Health
- Yahoo
Fractyl Health Reports Positive Early Data Showing Revita® Has Potential to Prevent Weight Regain After GLP-1 Discontinuation
New REVEAL-1 study results show early signs of weight maintenance after GLP-1 discontinuation REMAIN-1 pivotal study now more than 50% enrolled; midpoint data analysis anticipated in Q3 2025 BURLINGTON, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) ('the Company'), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced positive early data from the open-label REVEAL-1 cohort of its ongoing REMAIN-1 pivotal study. The results suggest that Revita, the Company's novel approach to targeting gut dysfunction, a root cause of obesity, may help prevent weight regain after patients stop GLP-1 drugs—addressing a growing unmet need in obesity treatment. As global GLP-1 adoption accelerates—and discontinuation rates climb—the need for scalable, non-pharmacologic solutions to sustain weight loss presents a significant, underleveraged commercial opportunity. Early Data Shows Evidence of Weight Maintenance and Reinforces Revita's Favorable Safety and Tolerability Profile To-date, 15 patients have been treated in the REVEAL-1 cohort, with 1-month data available for the first 7 patients. These patients have been treated with a GLP-1 drug for up to 3 years before discontinuing medication, undergoing a single Revita procedure, and continuing a structured diet and lifestyle program. Key findings include: No safety or tolerability concerns reported in the 15 patients treated to date, consistent with Revita's favorable safety profile from pooled data across more than 100 treated patients. At 1-month post-procedure, 7 patients experienced an average weight regain of just 1.2%, compared to the ~3% typically observed at this time period after GLP-1 discontinuation based on prior clinical studies1. "Stopping GLP-1 drugs often feels like a cliff for many patients—they fear regaining the weight they worked so hard to lose," said Mohammad Othman, M.D., William T. Butler Endowed Chair and Professor of Medicine at Baylor College of Medicine. "These early data suggest that a well-tolerated, one-time procedure like Revita could offer patients a new, sustainable path forward without the need for ongoing medical treatment." "The real challenge in obesity care isn't just helping patients lose weight—it's helping them keep it off," said Harith Rajagopalan, M.D., Ph.D., Co-Founder and CEO of Fractyl Health. "For the first time, we're seeing early clinical data suggesting that Revita may offer a durable metabolic reset to help patients maintain their weight loss after GLP-1 therapy. I'm encouraged by these initial findings, and if they are confirmed in larger studies with longer follow-up, Revita has the potential to become a transformative option for patients at risk of weight regain." Upcoming Data Milestones Fractyl anticipates several key milestones for Revita in 2025: Additional REVEAL-1 patient follow-up data expected in Q2 2025 Full REMAIN-1 pivotal study enrollment anticipated in summer 2025 Midpoint analysis of REMAIN-1 pivotal study expected in Q3 2025 Revita is currently being studied under an open Investigational Device Exemption (IDE) in the U.S. and holds FDA Breakthrough Device designation for weight maintenance in patients discontinuing GLP-1 therapy. The Company aims to position Revita as the first approved intervention specifically for post-GLP-1 weight maintenance. About Fractyl HealthFractyl 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, MA. For more information, visit About Revita®Fractyl Health's lead product candidate, Revita, is based on the company's insights surrounding the potential role of the gut in obesity. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e. duodenal mucosal resurfacing) to reverse damage to intestinal nutrient sensing and signaling mechanisms caused by chronic high-fat and high-sugar diets that are a root cause of metabolic disease. In the U.S., Revita is for investigational use only under U.S. law. Revita has U.S. FDA Breakthrough Device designation in weight maintenance for people with obesity who discontinue GLP-1 based drugs. A pivotal study of Revita in patients with obesity after discontinuation of GLP-1 based drugs, called REMAIN-1, was initiated in the third quarter of 2024 and is currently enrolling. Forward-Looking StatementsThis 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 studies or readouts, communications with regulators, the potential launch or commercialization of any of our product candidates or products, the potential treatment population or benefits for any of our product candidates or products, 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, and the timing of any of the foregoing. 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; 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 sub-assembly components for Revita, 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the 'SEC') on March 3, 2025 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 Media Contact Jessica Cotrone, Head of Corporate Communications jcotrone@ 978.760.5622 Investor Contact Brian Luque, Head of Investor Relations and Corporate DevelopmentIR@ 951.206.1200 1 Aronne LJ, Sattar N, Horn DB, et al. Continued Treatment with Tirzepatide for Maintenance of Weight Reduction in Adults with Obesity. Jama 2023;331(1):38– in to access your portfolio
Yahoo
31-01-2025
- Business
- Yahoo
Fractyl Health Announces Increased Focus on Groundbreaking Revita® Weight Maintenance and Rejuva® Pancreatic Gene Therapy Programs with Potential to Deliver Key Clinical Milestones Across Multiple Studies in 2025
Prioritizing Revita's clinical development on weight maintenance post-GLP-1 withdrawal in response to significant patient and physician demand in ongoing REMAIN-1 pivotal study; anticipate midpoint data analysis in Q2 2025 and full pivotal study enrollment in summer 2025 RJVA-001, first clinical candidate in Rejuva gene therapy program, has completed key preclinical in vivo studies; on-track to initiate first-in-human studies in H1 2025 Streamlined focus expected to extend cash runway into 2026 BURLINGTON, Mass., Jan. 31, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the 'Company'), a metabolic therapeutics company focused on pioneering pattern breaking approaches for the treatment of obesity and type 2 diabetes (T2D), today announced it is prioritizing its REMAIN-1 pivotal study, addressing the demand for an off-ramp to GLP-1 drugs, while advancing its novel Rejuva gene therapy platform into first-in-human studies. This decision is driven by positive initial feedback from the REVEAL-1 cohort, significant demand for participation in the REMAIN-1 study, and strong patient and physician feedback on the urgent need for durable weight maintenance solutions. Fractyl will pause investment in its Revita programs for T2D, which consist of the REVITALIZE-1 study and the German Real-World Registry. These measures are expected to extend the Company's cash runway into 2026, through multiple key clinical milestones. "The real challenge in obesity is no longer losing weight, it is keeping the weight off. The strong response from patients and physicians to the REMAIN-1 study highlights the urgent need for durable weight maintenance solutions, and we are doubling down on our efforts in this space," said Harith Rajagopalan, Co-Founder and CEO of Fractyl Health. "Revita is the first therapeutic candidate to receive Breakthrough Device designation for weight maintenance, and we are uniquely positioned to address this critical gap. By prioritizing REMAIN-1 and advancing our groundbreaking Rejuva gene therapy platform, we are channeling our resources toward what we believe are the most impactful and differentiated opportunities. Given the rapidly evolving obesity landscape, we are pausing investment in our Revita programs for T2D and sharpening our focus. We believe these strategic steps will enable us to execute on our mission of delivering truly transformative solutions for patients with obesity and metabolic disease." Revita Update: Promising Early Data and Midpoint Data Analysis in Q2 2025 Earlier this month, Fractyl reported positive preliminary results from the REVEAL-1 open-label cohort of the REMAIN-1 study. Initial findings from the first patient showed successful weight maintenance following GLP-1 drug discontinuation and Revita procedure. Additional data from the REVEAL-1 cohort is anticipated to be presented in Q1 2025. The Company also announced significant progress in its ongoing REMAIN-1 pivotal study, which is evaluating weight maintenance after discontinuation of GLP-1 drugs. Recruitment for the REMAIN-1 study has generated significant interest, with over 145 patients enrolled across 10 clinical study sites in 5 months since first site activation, reflecting strong engagement from both patients and physicians. This momentum underscores the urgent need for effective post-GLP-1 weight maintenance solutions. The Company has completed enrollment of a sufficient number of patients for the midpoint analysis of the study, which is on track and expected in Q2 2025. Full enrollment in the study is expected in the summer of 2025. The Company will pause investment in Revita for T2D, which includes the REVITALIZE-1 study and the German Real-World Registry. Rejuva Update: Pioneering Gene Therapy Progress into First-in-Human Studies After garnering significant scientific recognition over the past 12 months, Fractyl has completed key preclinical in vivo studies to support a Clinical Trial Application (CTA) for RJVA-001. The Company is on track to initiate first-in-human studies for RJVA-001 in H1 2025. Corporate Update The Company is streamlining resources, including a 17% workforce reduction, which is expected to extend its cash runway into 2026. About Fractyl HealthFractyl 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, MA. For more information, visit About Revita®Fractyl Health's lead product candidate, Revita, is based on the company's insights surrounding the potential role of the gut in obesity. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e. duodenal mucosal resurfacing) to reverse damage to intestinal nutrient sensing and signaling mechanisms caused by chronic high-fat and high-sugar diets that are a root cause of metabolic disease. In the U.S., Revita is for investigational use only under U.S. law. Revita has U.S. FDA Breakthrough Device designation in weight maintenance for people with obesity who discontinue GLP-1 based drugs. A pivotal study of Revita in patients with obesity after discontinuation of GLP-1 based drugs, called REMAIN-1, was initiated in the third quarter of 2024 and is currently enrolling. 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. The Company intends to initiate its first-in-human study for RJVA-001, the Company's first nominated GLP-1 pancreatic gene therapy candidate designed for the treatment of T2D, in the first half of 2025. Forward-Looking StatementsThis 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 our anticipated financial performance, including cash and cash equivalents, for any period of time, our strategic reprioritization and related workforce reduction, including its implementation and the expected costs and benefits, if any, the promise and potential impact of our preclinical or clinical trial data, the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, the content, information used for, timing or results of any IND-enabling studies, IND applications or Clinical Trial Applications, the potential launch or commercialization of any of our product candidates or products, the potential treatment population or benefits for any of our product candidates or products, 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, and the timing of any of the foregoing. 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 November 12, 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 Media Contact Jessica Cotrone, Head of Corporate Communications jcotrone@ 978.760.5622 Investor Contact Brian Luque, Head of Investor Relations and Corporate DevelopmentIR@ 951.206.1200Sign in to access your portfolio
