Category Archives: Biotech Companies

SCHOTT Pharma appoints Tobias Erfurth as Head of Investor Relations

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  • Tobias Erfurth will lead Investor Relations Team starting in August 2024.
  • He brings more than 20 years of experience in finance, capital markets and investor relations.

SCHOTT Pharma, a pioneer in pharma drug containment solutions and delivery systems, today announced the appointment of Tobias Erfurth as Head of Investor Relations effective August 2024. He will strengthen and expand the Investor Relations team at SCHOTT Pharma and will report to CFO Almuth Steinkühler. “Tobias joining our finance team is a real win for SCHOTT Pharma. With his extensive expertise and DAX40 experience, we look forward to further growing SCHOTT Pharma’s presence in the capital markets and showcasing our attractive financial profile,” said Dr. Almuth Steinkühler, CFO of SCHOTT Pharma.

Tobias Erfurth has gained more than 20 years of experience in finance, capital markets and investor relations, both from corporate positions and roles in banking. In his most recent position as Head of Investor Relations at Symrise AG for over 13 years, Erfurth was responsible for managing all investor activities during the company’s development from a small cap to a member of the DAX40. Prior to that, Erfurth accompanied the IPO of Crop Energies AG and subsequently built up the investor relations department. Erfurth also has extensive experience in corporate finance and equity capital markets gained in his previous role as analyst at Dresdner Bank.

“With its convincing equity story, dynamic growth, attractive margins, SCHOTT Pharma is a true success story, and I look forward to joining the team. Together, we will continue to deepen the established relationships with investors and analysts and help key stakeholders to understand SCHOTT Pharma’s strategy and its role as a pioneer in one of the fastest growing markets of the pharma industry,” said Tobias Erfurth.

For additional news about SCHOTT Pharma please visit our media center.

About SCHOTT Pharma

Human health matters. That is why SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. The portfolio comprises drug containment solutions and delivery systems for injectable drugs ranging from prefillable glass and polymer syringes to cartridges, vials, and ampoules. Every day, a team of over 4,600 people from over 60 nations works at SCHOTT Pharma to contribute to global healthcare. The company is represented in all main pharmaceutical hubs with 16 manufacturing sites in Europe, North and South America, and Asia. With over 1,000 patents and technologies developed in-house and a state-of-the-art R&D center in Switzerland, the company is focused on developing innovations for the future. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the SDAX. It is part of SCHOTT AG, which is owned by the Carl Zeiss Foundation. In light of this spirit, SCHOTT Pharma is committed to sustainable development for society and the environment and has the strategic goal of becoming climate-neutral by 2030. Currently, SCHOTT Pharma has over 1,800 customers including the top 30 leading pharma manufacturers for injectable drugs and generated revenue of EUR 899 million in the fiscal year 2023.

 

Press contact

Joana Kornblum

Media Relations

Tel.: +49 151/29223552

E-Mail: joana.kornblum@schott.com

Investor contact

Jasko Terzic, CFA

Senior Manager Investor Relations

E-Mail: ir.pharma@schott.com

 

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Qlaris Bio Completes $24 Million Series B Financing Round to Advance QLS‑111, a First-in-class IOP-lowering Drug Candidate for Glaucoma

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Financing led by Canaan and New Leaf Venture Partners, and includes funds managed by abrdn Inc., Correlation Ventures, and Mayo Clinic Ventures

DEDHAM, Mass.–(BUSINESS WIRE)–#EVP—Qlaris Bio, Inc. (“Qlaris”), a clinical-stage biotechnology company targeting unmet needs in debilitating ophthalmic diseases, today announced that it has closed a $24 million Series B financing round. Co-led by Canaan and New Leaf Venture Partners, the financing also included new participation from funds managed by abrdn Inc., as well as existing investors Mayo Clinic Ventures and Correlation Ventures.

Proceeds from the financing will support the continued clinical development of QLS‑111, a first-in-class therapeutic being developed to lower intraocular pressure (IOP) by targeting episcleral venous pressure (EVP). Qlaris is currently conducting two U.S. Phase II clinical trials of QLS‑111 (Osprey and Apteryx). The Osprey and Apteryx studies are investigating the safety, tolerability, optimal dosing, and efficacy of QLS‑111 in patients with open angle glaucoma (OAG) and ocular hypertension (OHT). Additional clinical advancements, including the initiation of the Nightingale Phase II clinical trial in normal tension glaucoma (NTG), are anticipated by the end of 2024.

The science behind QLS‑111 originated in the lab of Dr. Michael Fautsch, Ph.D., a Mayo Clinic professor of ophthalmology, biochemistry, and molecular biology. The drug candidate aims to lower IOP by relaxing vessels of vascular and vascular-like tissues distal to the trabecular meshwork, thereby reducing distal outflow resistance and lowering EVP. As there are currently no approved medications that selectively target the reduction of EVP, there is a significant gap in the potential to maximally lower IOP, as EVP can be the largest determinant of overall IOP. Preliminary data suggest that QLS‑111 is well-tolerated with no significant hyperemia or safety concerns.

“We are grateful to have the support of this outstanding syndicate of leading life science investors, which will enable the continued development of our lead product, QLS‑111,” said Thurein Htoo, MS, MBA, Chief Executive Officer of Qlaris. “Qlaris is dedicated to developing new mechanisms of action that target unaddressed parameters within IOP regulation, an area of critical need. QLS‑111 aims to achieve this goal by fundamentally targeting EVP to enable improved IOP control for patients with glaucoma, including those with NTG, a condition for which there are no currently approved therapeutics. This funding will provide Qlaris the means to execute on our clinical strategy to develop a novel solution to a critical unmet need.”

“Since the company’s inception, we have believed in Qlaris’ novel technology, talented leadership, and skilled team,” said Wende Hutton, General Partner at Canaan. “We invest in companies that partner an innovative approach with strong leadership and accomplished scientists to successfully reach critical milestones. Qlaris has the potential to demonstrate the importance of targeting EVP in the ongoing QLS‑111 Phase II trials and we look forward to the data from this innovative drug candidate.”

About Qlaris Bio, Inc.

Qlaris Bio, Inc. was founded in August 2019 with a singular focus: to develop novel, innovative therapies with first-in-class mechanisms of action to address serious and debilitating ophthalmic diseases. The company’s lead program, QLS‑111, uses ATP-sensitive potassium channel modulators that improve outflow through distal vascular tissues of the eye to reduce IOP. Qlaris Bio’s investors include Canaan and New Leaf Venture Partners, both of which were co-lead investors in the company’s $25 million Series A funding round in August 2019. Other investors include Correlation Ventures, Mayo Clinic, and funds managed by abrdn Inc. For more information, please visit qlaris.bio.

Contacts

Michele Gray

michele@mgraycommunications.com
(917) 449-9250

Newron Pharmaceuticals announces positive top-line results from potentially pivotal Phase II/III study 008A with evenamide in schizophrenia patients

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Primary endpoint and key secondary endpoint of study met; drug was well tolerated, with no safety concerns identified

Glutamatergic inhibition mechanism of action offers an innovative therapeutic option to schizophrenia patients not benefitting from current antipsychotic treatments

Next step: Potentially pivotal, Phase III, one-year, randomized, double-blind, placebo-controlled trial in treatment resistant schizophrenia (TRS)

Milan, Italy, April 30, 2024, 07:00 am CEST – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), today announced positive top-line results from its potentially pivotal study 008A, evaluating the safety, tolerability and efficacy of evenamide (30 mg bid) in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic including clozapine, but demonstrating an inadequate response to that treatment. The study met its primary endpoint of improvement on the Positive and Negative Syndrome Scale (PANSS) Total Score as well as the key secondary endpoint of improvement of the Clinical Global Impression of Severity (CGI-S).

Study 008A was a four-week, international, randomized, double-blind and placebo-controlled add-on Phase II/III study performed in 45 centers in 11 countries in Europe, Asia and Latin America. 291 patients were randomized to treatment either with evenamide or placebo as add-on to their current antipsychotic therapy.

Evenamide confirmed its favourable safety and tolerability profile, with a high rate of completion. Two hundred and eighty of the 291 patients completed the study with only three patients discontinuing the study due to adverse events, two of them on evenamide and one patient on placebo who died during the study.  No new or specific concerns were raised in the study; only 25% of the patients in the study experienced at least one adverse event (evenamide 25% versus placebo 25.8%). There was no difference in the incidence of CNS, psychiatric, gastrointestinal or other adverse events between evenamide and placebo. The most common adverse events reported in patients treated with evenamide were headache, vomiting and nasopharyngitis (three patients, each); similar numbers of patients on placebo experienced these adverse events.

In the study, the addition of 30 mg (bid) of evenamide to the patients’ current antipsychotic medication was associated with a highly statistically significant (p-value 0.006) reduction in the PANSS Total Score of 10.2 points, compared to 7.6 points in patients treated with placebo at day 29; the least square mean difference (LS mean difference) was 2.5. For the key secondary measure, the Clinical Global Impression of Severity (CGI-S), the LS mean difference between patients treated with evenamide and placebo was 0.16; the corresponding p-value was 0.037.

Ravi Anand, MD, Chief Medical Officer of Newron, stated: “The results seen in study 008A with evenamide are ground-breaking and unique from many perspectives. This is the first major international study to demonstrate the significant benefit of adding a new chemical entity (NCE) to poorly responding, compliant schizophrenia patients being treated with a second-generation antipsychotic. It is also the first demonstration of efficacy in a placebo-controlled trial of a NCE acting exclusively through glutamatergic inhibition. These results, together with the recently reported one-year efficacy results in treatment-resistant patients, substantiate the pivotal role of glutamate in finding new therapeutic options for schizophrenia patients.”

Additional details from the study will be disclosed in the coming weeks.

Media/analyst/investor Conference Call today at 3 pm CET

Newron’s management team will be available today to discuss the top-line results from study 008A. Please dial in five to ten minutes prior to the beginning of the call using one of the following telephone numbers:

  • Switzerland/Europe: +41 (0)58 310 50 00
  • Germany: +49 (0)69 505 0 0082
  • United Kingdom: +44 (0)207 107 0613
  • United States: +1 (1)631 570 5613
  • Japan: +81 35 050 5361

About evenamide

Evenamide, an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs) and is devoid of biological activity at >130 other CNS targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of ineffective doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide benefit in patients who are poor responders to current APs, including clozapine.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron’s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with symptoms of schizophrenia. For more information, please visit: www.newron.com

For more information, please contact:

Newron
Stefan Weber – CEO
+39 02 6103 46 26
pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting
+44 20 3727 1000
SCnewron@fticonsulting.com

Switzerland
Valentin Handschin, IRF
+41 43 244 81 54
handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Caroline Bergmann, MC Services
+49 211 52925222
newron@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience
+1 617 374 8800, Ext. 112
psagan@lavoiehealthscience.com

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

30.04.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com

Language: English
Company: Newron Pharmaceuticals S.p.A.
via Ludovico Ariosto 21
20091 Bresso
Italy
Phone: +39 02 610 3461
Fax: +39 02 610 34654
E-mail: pr@newron.com
Internet: www.newron.com
ISIN: IT0004147952
WKN: A0LF18
Listed: Regulated Unofficial Market in Dusseldorf (Primärmarkt); London, SIX
EQS News ID: 1892237
End of News EQS News Service

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BosterBio : 30 years designing high affinity antibodies and immunoassays

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BosterBio is a distinguished authority in the realm of antibody and ELISA expertise, boasting a legacy of three decades dedicated to crafting high-affinity antibodies and cutting-edge immunoassays. Our mission is to cater to the brightest minds in scientific research, equipping them with the tools and resources necessary to advance their investigations.

ABOUT BOSTER BIO: 
Nestled at the forefront of scientific innovation, Boster Bio stands as your premier destination for state-of-the-art ELISA kits, antibodies, custom reagents, and analytical services across a spectrum of disciplines including immunology, sequencing, and cancer research. With a comprehensive range of product categories including Antibodies, ELISA Kits, Recombinant Proteins, and Reagent Kits, we provide researchers with the essential building blocks to unlock new insights and propel their discoveries forward.

Located at strategic hubs in the heart of scientific communities, including [insert addresses here], Boster Bio operates globally, ensuring accessibility to our unparalleled resources for researchers worldwide. Our team of seasoned professionals is committed to delivering excellence, working tirelessly to exceed expectations and empower researchers to realize their full potential.
At Boster Bio, we are driven by a steadfast dedication to advancing scientific knowledge and catalyzing therapeutic breakthroughs. Explore how we can collaborate with you to drive your research forward by visiting our website at www.bosterbio.com .

Boster Bio – Empowering Scientific Discovery – Antibody and ELISA Experts – Immunology – Cancer Research – Scientific Innovation

Xeno Biosciences Announces New CEO and Financing

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CAMBRIDGE, Mass.–(BUSINESS WIRE)–Xeno Biosciences Inc., a clinical stage drug discovery and development company advancing therapeutics for the treatment of obesity and metabolic diseases, announced today a change in executive leadership as of September 2023, and the completion of an additional financing round in February of 2024. This financing of $1.15M will fund a Phase 1b trial of the company’s lead compound, Xen-101, in obese individuals. The trial is expected to have top line results by the end of the year.

The new president and CEO, Dennis D. Kim, MD, MBA, has 25 years of obesity and metabolic drug development expertise experience and has brought multiple obesity and metabolic disease drugs to the clinic and to market, including Byetta® (exenatide), Symlin® (pramlintide), Contrave® (bupropion/naltrexone), and seladelpar. He has been involved in numerous IPO’s/secondary offerings and has been the chief medical officer of multiple public companies, most recently at CymaBay Therapeutics, where he oversaw the design and execution of seladelpar Phase 3 Pivotal Program.

“I’m excited to be spearheading the development of Xeno’s new oral obesity drug which has been shown to have high tolerability in initial Phase I trial and has a novel mechanism of action.” said Dr. Dennis Kim. “I have dedicated my career to this area of science and medicine. After many years of development, I am truly gratified to see obesity pharmaceuticals as having the potential to impact the lives of billions of people around the world. There is a strong unmet need for a drug with the profile of Xen-101 and I look forward to our Phase 1b clinical trial results in obese adults in the near future.”

“Dennis has an extraordinary depth of knowledge and is highly respected in the obesity field; I could not imagine anyone more perfect to lead our company,” said Jeff Arnold, Chairman and a Director at Xeno since 2017. “We are delighted that he has decided to join us and lead this exciting project.”

For more information about Xeno Biosciences please contact Dr. Dennis Kim at dk23@xenobiosciences.com.

About Xeno Biosciences Inc.

Xeno Biosciences Inc. is a privately held drug development company dedicated to finding safe and effective treatments for obesity and metabolic diseases. Xeno is advancing its lead development candidate, XEN-101, to address the unmet need for an effective, well-tolerated, orally administered obesity treatment. With a new understanding of the underlying mechanism of action of Roux-en-Y Gastric Bypass Surgery (RYGB), Xeno has developed a substitute for gastric bypass in a daily oral pill. XEN-101 has been shown to have wide safety margins and high tolerability in initial clinical trials.

Dennis D. Kim, MD, MBA

Dr. Dennis Kim is a scientist and a physician executive who brings 25 years of clinical research and biopharmaceutical industry experience to Xeno Biosciences. Dr. Kim served in a variety of senior executive positions in the industry, most recently as Chief Medical Officer at CymaBay, Emerald Biosciences, and Zafgen, Inc., as well as at Orexigen Therapeutics as the Senior Vice President of Medical Affairs. He also held various senior management positions at Amylin Pharmaceuticals, Inc. for over 7 years, including Executive Director of Corporate Strategy and Program Medical Lead for the development and commercialization of Byetta® (exenatide) for the treatment of type 2 diabetes.

Dr. Kim completed his fellowship in Endocrinology/Metabolism at the University of California, San Diego (UCSD) School of Medicine during which time he investigated the pathophysiology of diabetes and metabolic syndrome. He is extensively published in top peer-reviewed medical and scientific journals with over 50 publications to his name. Dr. Kim also received an MBA degree with honors from UCSD Rady School of Management with an emphasis on biotech structure and strategy.

The securities sold in the aforementioned private placement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States in the absence of an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the aforementioned shares. In addition, this press release contains certain forward-looking statements regarding, among other things, statements relating to goals, plans and projections regarding the company’s financial position, results of operations, market position, product development and business strategy. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and the company undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Contacts

Dr. Dennis Kim

dk23@xenobiosciences.com

Jacques Banchereau, PhD Appointed as Chief Scientific Officer at Javelin Biotech

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WOBURN, Mass.–(BUSINESS WIRE)–Javelin Biotech, Inc., a leading technology company specializing in human tissue chip platforms for biopharma research, is delighted to announce the appointment of Jacques Banchereau, PhD as its Chief Scientific Officer (CSO). Banchereau is an internationally recognized immunologist and molecular biologist, renowned for his groundbreaking contributions to the field of immunology and drug discovery.

Over his distinguished 35-year career, Dr. Banchereau has shown exceptional leadership in both academic and industrial research. Having held esteemed roles such as Professor and Director of Immunological Sciences at the Jackson Laboratory for Genomic Medicine, Chief Scientific Officer at Hoffman-La Roche, CSO at Immunai, and Adjunct Professor of Immunobiology at Yale School of Medicine, he has consistently demonstrated his expertise in driving forward scientific inquiry and pharmaceutical innovation.

In his role at Javelin Biotech, Banchereau will oversee the company’s scientific strategy, leveraging his vast experience and expertise to drive the development of cutting-edge technology for the modeling of human diseases. His appointment underscores Javelin Biotech’s commitment to innovation and scientific excellence in the field of biotechnology.

“We are thrilled to welcome Jacques to the Javelin Biotech team,” said Murat Cirit, PhD, CEO of Javelin Biotech. “His outstanding achievements and leadership in immunology and drug discovery make him a valuable addition to our company. We are confident that his expertise will play a pivotal role in advancing our research efforts and driving our mission to support the development of novel treatments for organ-specific diseases.”

Banchereau expressed his excitement about joining Javelin Biotech, stating, “I am honored to be part of a company that is dedicated to pushing the boundaries of scientific research. Javelin Biotech’s innovative technology has the potential to revolutionize the way we understand and treat complex diseases, and I look forward to contributing to its success.”

About Javelin Biotech:

Javelin Biotech is a biotechnology company focused on humanizing preclinical drug discovery with a predictive platform that merges human tissue chips with digital twin technology to develop better medicines faster. The Javelin platform enables the creation of accurate and physiologically relevant models of human tissues, providing valuable insights into disease mechanisms and drug responses, allowing biopharmaceutical companies to reduce their reliance on animal studies and develop better drugs faster.

For more information, visit www.javelinbiotech.com.

Contacts

Kevin O’Handley

media@javelinbio.com
(781) 995-3099

Allurion Closes $48 Million Convertible Senior Secured Note Financing with RTW Investments

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  • Simplifies capital structure through prepayment of existing term loan
  • Reduces annual interest expense, providing increased near-term cash flow and operational flexibility
  • Extends expected cash runway in advance of AUDACITY FDA trial read-out
  • Strengthens long-term partnership with RTW Investments.

NATICK, Mass.–(BUSINESS WIRE)–Allurion Technologies, Inc. (NYSE: ALUR) (“Allurion” or the “Company”), a company dedicated to ending obesity, today announced the closing of a $48 million convertible senior secured note financing with certain entities managed by RTW Investments, LP (“RTW”). Proceeds will be used to repay in full the Company’s obligations under its existing term loan with Fortress Credit Corp., reducing the Company’s interest expense and increasing operational flexibility.

Management anticipates this transaction will better position the business for the future. Of note, the convertible notes reduce the interest rate on the Company’s debt to 6%, lengthen the maturity over Allurion’s existing term loan by nearly four years, from June 2027 to April 2031, and allow for interest payments to be made in-kind for the first three years. The net benefit of these changes, together with the amended terms of Allurion’s existing Royalty Interest Financing Agreement with RTW, extends the Company’s expected cash runway in advance of the AUDACITY FDA trial read-out, which is anticipated by year-end.

“RTW’s investment underscores our shared belief in the long-term potential of the Allurion Program,” said Dr. Shantanu Gaur, Founder and CEO of Allurion. “Our impressive clinical results and continued growth in procedural volume in our foreign markets give us confidence that Allurion will be a significant player in obesity management. The investment furthers our long-term partnership with RTW and provides us additional flexibility to achieve our long-term goals,” Dr. Gaur continued.

“We are pleased to strengthen our relationship with Allurion as it continues its mission to end obesity around the world. The Allurion Program is a proven weight-loss method, and we eagerly await the results of its U.S. FDA trial,” said Roderick Wong, M.D., Managing Partner and Chief Investment Officer of RTW Investments, LP.

About the Notes

The notes bear interest at the rate of 6% per annum, with the Company’s option to pay interest in kind for the first three years, and mature on April 16, 2031. The notes may be converted at the option of the noteholders into common stock of Allurion, subject to certain conditions and limitations, at a 35% conversion premium to the lower of (i) the 30-day VWAP at signing and (ii) the price per share in the Company’s next equity offering. The Company has agreed to customary registration rights with respect to the shares of common stock issuable upon conversion of the notes. The notes may be redeemed by Allurion at its option under certain circumstances following the fourth anniversary of the date of issuance.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

Additional information about the notes and the terms of the note purchase agreement will be filed with the U.S. Securities and Exchange Commission (the “SEC”) and will be available on the SEC’s website at www.sec.gov.

About Allurion

Allurion is dedicated to ending obesity. The Allurion Program is a weight loss platform that features the Allurion Gastric Balloon, the world’s first and only swallowable, procedure-less intragastric balloon for weight loss, and offers access to the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers, Allurion Insights for health care providers featuring the Coach Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor and manage weight loss therapy for patients regardless of their treatment plan: gastric balloon, surgical, medical or nutritional. The Allurion Gastric Balloon is an investigational device in the United States.

For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com

Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world.

About RTW

RTW Investments, LP is a global, full life-cycle investment firm and company builder that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to support emerging medical therapies and the companies and/or academics developing them.

Forward-Looking Statements

This press release may contain certain forward-looking statements within the meaning of the U.S. federal and state securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions and include statements regarding the simplification of Allurion’s capital structure, availability of cash runway, operational flexibility, procedure growth, Allurion’s expectations for, and market acceptance of, the Allurion Program, and Allurion’s ability to compete with other weight loss products, improve its market position, scale its business and achieve long-term goals. Forward-looking statements are predictions, projections and other statements about future events that reflect the current beliefs and assumptions of Allurion’s management based on information currently available to them and, as a result, are subject to risks and uncertainties. Many factors could cause actual future results or developments to differ materially from the forward-looking statements in this communication, including but not limited to (i) the ability of Allurion to obtain and maintain regulatory approvals for and successfully commercialize the Allurion Program, including the Allurion Balloon and the Allurion Virtual Care Suite (“VCS”), (ii) the timing of, and results from, our clinical studies and trials, (iii) the evolution of the markets in which Allurion competes, (iv) the ability of Allurion to defend its intellectual property, (v) the impact of the COVID-19 pandemic, the Russia and Ukraine war, and the Israel-Hamas conflict on Allurion’s business, (vi) Allurion’s expectations regarding its market opportunities, including those for the VCS platform, (vii) the risk of economic downturns and a changing regulatory landscape in the highly competitive industry in which Allurion operates, and (viii) the ability of Allurion to comply with the covenants and terms and conditions of the note purchase agreement. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Allurion’s Annual Report on Form 10-K filed on March 26, 2024 and other documents filed by Allurion from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Allurion assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Allurion does not give any assurance that it will achieve its expectations.

Contacts

Global Media:
Cedric Damour, PR Manager

Allurion Technologies, Inc.

+33 7 84 21 02 20

cdamour@allurion.com

Investors
Mike Cavanaugh, Investor Relations

ICR Westwicke

+1 617 877-9641

mike.cavanaugh@westwicke.com

Ventus Therapeutics Announces Results from Phase 1 Clinical Trial of VENT-02, a Novel, Orally Administered, Brain-Penetrant NLRP3 Inhibitor

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VENT-02 demonstrated robust pharmacodynamic modulation, a broad therapeutic index, and potential for once-daily dosing

VENT-02 provided full target coverage with a single dose

No dose-limiting toxicities or serious adverse events observed

Initiation of clinical trials in CNS diseases expected beginning in the second half of 2024

WALTHAM, Mass. & MONTREAL–(BUSINESS WIRE)–Ventus Therapeutics, a clinical-stage biopharmaceutical company utilizing its proprietary structural biology and computational chemistry platform, ReSOLVE™, to develop differentiated small molecule therapeutics, today announced results from its Phase 1 clinical trial of VENT-02, a novel, oral, brain-penetrant NLRP3 inhibitor. The Phase 1 trial evaluated the pharmacodynamics, pharmacokinetics, safety, and tolerability of VENT-02 across a broad range of single and multiple ascending doses in adult healthy volunteers.

“We are pleased with the results of this trial in which VENT-02 demonstrated a broad therapeutic index and complete target coverage, underscoring its potential to treat diseases of the CNS as well as peripheral diseases with high unmet needs,” said Xavier Valencia, M.D., Head of Clinical Development at Ventus. “Our next trial for VENT-02, a Phase 1b trial in patients with Parkinson’s disease, will evaluate multiple doses and dose regimens against a placebo control and assess a collection of markers that map multiple components of inflammation to disease activity. Based on the promising pharmacodynamic and safety data from this Phase 1 trial and our clinical development plans, we believe VENT-02 is poised to demonstrate best-in-class potential.”

In this Phase 1 clinical trial, VENT-02 was well-tolerated, with no dose-limiting toxicities or serious adverse events reported and only mild or moderate treatment-related adverse events observed. The moderate adverse events included headache and nausea and were only observed at a dose multiple times higher than the intended therapeutic doses.

VENT-02 demonstrated full target engagement through 100% inhibition of IL-1ß in the blood in an ex vivo whole blood challenge assay, significant drug levels in the CSF for 24 hours, and robust reduction of inflammatory biomarkers such as hsCRP. Based on the half-life and target coverage observed in the trial, VENT-02 has demonstrated the potential for once-daily dosing.

“The excellent properties of VENT-02 are a reflection of Ventus’ industry-leading exploration of NLRP3, including demonstrating proof-of-concept in preclinical studies in multiple disease-relevant models, validating biomarkers, and collaborating with academic institutions and the Michael J. Fox Foundation,” said Ventus President and CEO, Marcelo Bigal, M.D., Ph.D. “As a result, we are ready to bring VENT-02 into Parkinson’s disease and other pre-defined diseases where the CNS plays an important role, capitalizing on innovative trials that we are crafting to be informative in reducing risk in the future steps of clinical development. In addition, we expect that our planned trials will allow us to explore the potential impact of NLRP3 inhibition across multiple patient populations suffering from serious diseases.”

Ventus expects to initiate a Phase 1b trial of VENT-02 in patients with Parkinson’s disease in the second half of 2024 and a Phase 2 trial in patients with treatment-refractory epilepsy in 2025.

About NLRP3

NLRP3 is the best understood member of a family of proteins known as inflammasomes. Inflammasomes are multiprotein complexes that regulate the innate immune system and are involved in intracellular surveillance of danger and pathogen signals that trigger an intense inflammatory response, including the release of IL-1β and IL-18 and the induction of pyroptosis, an inflammatory form of cell death. Therapeutic inhibition of NLRP3 can prevent the formation of the NLRP3 inflammasome, which in turn inhibits the production of IL-1β and IL-18 as well as pyroptosis. Aberrant activation of the NLRP3 inflammasome has been associated with systemic conditions, including fibrotic, dermatological, and rheumatological diseases, and is a key driver of disease pathology in several neurological disorders, including Parkinson’s disease, Alzheimer’s disease, and treatment-refractory epilepsy.

About Ventus Therapeutics

Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying deep protein science expertise and a proprietary computational chemistry platform to develop novel small molecule therapeutics for immunology, inflammation, and neurology disorders. Using its proprietary drug discovery platform, ReSOLVE™, the company screened its first target in 2020, selected three development candidates in 2022, and advanced its two wholly-owned product candidates into the clinic in 2023: VENT-03, a potent, selective, oral cGAS inhibitor in Phase 1, and VENT-02, a potent, brain-penetrant, oral NLRP3 inhibitor in Phase 1. In addition, Ventus has out-licensed VENT-01, a peripherally-restricted NLRP3 inhibitor, to Novo Nordisk A/S. These programs exemplify Ventus’ robust discovery capabilities and focus on differentiated programs for multi-indication immunology and neurology targets. For more information, please visit www.ventustx.com and engage with Ventus on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that may cause Ventus’ actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue” or the negative of these terms or other similar expressions. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the timing, progress, and results of Ventus’ clinical trials, the anticipated timing of initiation and completion of trials, the period during which the results of the trials will become available, and Ventus’ development plans. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond Ventus’ control, you should not rely on these forward-looking statements as predictions of future events. Such risks include, but are not limited to, the risk that Ventus is unable to further advance VENT-02 and VENT-03 in clinical development, obtain regulatory approval, and ultimately commercialize VENT-02 and VENT-03, or experience significant delays in doing so; that Ventus will require substantial additional funding to finance its operations; that the development and commercialization of pharmaceutical products is subject to extensive regulation, and the regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable; and that Ventus’ success depends on its, its current and future licensors’, and its exclusive licensees’ ability to obtain, maintain, enforce, and protect its intellectual property and its proprietary technologies. Forward-looking statements included herein are based upon information available to Ventus as of the date of this press release, and while Ventus believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and Ventus’ statements should not be read to indicate that it has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Ventus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise.

Contacts

Media
Dan Budwick

1AB

dan@1abmedia.com

Theolytics successfully closes latest financing raising total of £19M ($24.5M) and welcomes Sound Bioventures as new investor

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Oxford, UK April 17th, 2024. Theolytics, a biotechnology company developing next-generation oncolytic viral therapies, today announced it has successfully closed its latest financing round, raising a total of £19M ($24.5M) with the addition of Sound Bioventures as a new investor. Sound Bioventures joins a strong international syndicate of existing investors participating in the round that includes M Ventures, Taiho Ventures, Epidarex Capital, Oxford Science Enterprises and the University of Oxford.

The proceeds from this financing round further strengthen the company’s position as it advances its lead oncolytic adenovirus – THEO-260 – into clinical trials in ovarian cancer. The first trials are planned for this year and will aim to demonstrate safe, effective administration, and provide insight to the candidate’s dual cancer/cancer-associated fibroblast-killing and immunomodulatory mechanism of action when administered by intravenous or intraperitoneal routes in platinum-resistant ovarian cancer patients.

Following this investment, Thomas Tan, Principal at Sound Bioventures, will join Theolytics’ Board of Directors.

Charlotte Casebourne Stock, Chief Executive Officer of Theolytics, said; “We’re on the brink of a potential step-change for the oncolytic adenovirus field. Our lead asset THEO-260 will be entering the clinic this year, and at this key juncture we are pleased to complete this significant financing and welcome Sound Bioventures as a new investor alongside our existing investors. Sound Bioventures’ extensive oncology experience, network, operational expertise and collaborative approach will bring important benefits to Theolytics and I am delighted to welcome Thomas Tan to our Board.”

Thomas Tan, Principal at Sound Bioventures, added; “The oncolytic virus modality is rapidly evolving, and we believe that Theolytics is well positioned at the forefront of this exciting therapy area. With THEO-260 about to enter the clinic, we see a significant opportunity to help bring an important and potentially practice-changing therapy to the many women suffering from this fatal disease. I look forward to working with the Board and management team bringing our hands-on approach to support the company’s unwavering fight against cancer.”

“THEO-260 has the potential to bring a much-needed new therapy to ovarian cancer patients and their families that are impacted by this devastating disease,” said Mike Grey, Executive Chair of the Board. “Theolytics is at a pivotal point as it approaches its first clinical trial and we are delighted to welcome Sound Bioventures, a highly knowledgeable and experienced investor with extensive oncology and company building expertise, to our group of leading international investors.”

About Ovarian Cancer (OC)

It is estimated that around 7,500 women in the UK and 20,000 women in the US will be diagnosed with ovarian cancer in 2024. More than 75% of cases will be diagnosed at an advanced stage (grade-III/IV) with less than 25% of patients expected to survive for more than five years.

Standard-of-care, first-line treatments combine cytoreductive-surgery, platinum-based chemotherapies, and paclitaxel. Although initially effective, more than 70% of patients relapse within three years and become resistant to platinum-based therapies. There are no effective treatments for platinum-resistant OC and at this point patients have a life-expectancy of less than 12 months.

About THEO-260

THEO-260 is a next-generation oncolytic adenovirus for the treatment of (platinum-resistant) ovarian cancer. It is highly efficacious in killing cancer cells and cancer-associated fibroblasts in ovarian cancer patient tumour samples. The destruction of cancer-associated fibroblasts, in addition to cancer cells, is a potentially differentiating feature of THEO-260 as cancer-associated fibroblasts in stromal-rich tumours are a barrier to the effectiveness of many cancer treatments. THEO-260 is being explored as a therapeutic for intravenous and intraperitoneal delivery.

About Theolytics

Theolytics is working to develop next-generation oncolytic viral therapies. The company has pioneered a new approach to develop efficacious, targeted candidates suitable for systemic intravenous delivery.

The company is focused on the advancement of its lead program THEO-260 into the clinic with the ambition of providing better outcomes for patients with ovarian cancer, for whom current treatment options are limited. Additional pipeline programmes in preclinical development include novel candidates developed for colorectal cancer and hematological malignancies where there remains significant unmet need.

Theolytics, which was founded in 2017 and is headquartered in Oxford, UK, is backed by international life sciences investors M Ventures, Taiho Ventures, Epidarex Capital, Oxford Science Enterprises, Sound Bioventures and the University of Oxford.

www.theolytics.com

About our Investors

For more information on our investors please see the following websites:
M Ventures 
Taiho Ventures 
Epidarex Capital 
Oxford Science Enterprises
Sound Bioventures
The University of Oxford

Contacts

Theolytics
enquiries@theolytics.com

Medincell Enters Into Strategic Co-development and Licensing Agreement with AbbVie to Develop Next-generation Long-acting Injectable Therapies

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Medincell will receive an upfront payment of $35 million and is eligible for up to $1.9 billion in potential development and commercial milestones, plus royalties on worldwide sales.

Medincell and AbbVie will co-develop, and AbbVie will commercialize up to six cutting-edge long-acting injectables (LAI).

The first LAI program candidate has been selected and formulation activities are underway.

This pivotal alliance leverages Medincell’s commercial-stage LAI technology and development know-how, and AbbVie’s extensive clinical development and commercialization expertise, to deliver innovative therapeutic solutions to patients globally.

MONTPELLIER, France–(BUSINESS WIRE)–Medincell (Paris:MEDCL) today announced a collaboration with AbbVie to co-develop and commercialize up to six therapeutic products across multiple therapeutic areas and indications. Medincell will use its commercial-stage long-acting injectable technology platform to formulate innovative therapies. Medincell will conduct formulation activities and preclinical studies, including supportive CMC work to advance candidates into clinical trials. AbbVie will finance and conduct the clinical development for each program and will be responsible for regulatory approval, manufacturing, and commercialization.

Christophe Douat, Medincell’s CEO said: “This will be an exciting partnership with one of the most innovative and successful pharmaceutical companies. Medincell has entered a new period of growth following the FDA approval of the first product using our technology in April 2023. The full potential of long-acting injectable therapies is getting increasingly recognized.”

Sébastien Enault, Medincell’s Chief Business Officer added: “Our business development is accelerating following FDA approval of our first product. Our technology can help harvest the full potential of many known or yet untapped drugs. We are ready to make this exciting partnership very successful.”

Under the terms of the co-development and licensing agreement covering up to 6 programs, Medincell will receive a $35 million upfront payment and is eligible to receive up to $1.9 billion in development and commercial milestones ($315 million for each program). Medincell is also eligible to receive mid-single to low-double-digit royalties on net sales.

About Medincell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY® (BEPO® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities.

UZED® and SteadyTeq™ are trademarks of Teva Pharmaceuticals

www.medincell.com

Contacts

David Heuzé
Head of Corporate and Financial Communications, and ESG

david.heuze@medincell.com / +33 (0)6 83 25 21 86

Grace Kim
Head of US Financial Strategy & IR

grace.kim@medincell.com / +1 (646) 991-4023

Nicolas Mérigeau
Media Relations

medincell@newcap.eu / +33 (0)1 44 71 94 94

Louis-Victor Delouvrier/Alban Dufumier
Investor Relations France

medincell@newcap.eu / +33 (0)1 44 71 94 94