Booster Therapeutics Launches to Pioneer New Class of Proteasome Activator Medicines for the Treatment of a Range of Complex Diseases




Booster Therapeutics Launches to Pioneer New Class of Proteasome Activator Medicines for the Treatment of a Range of Complex Diseases

$15 million seed financing led by Apollo Health Ventures and Novo Holdings

New approach aims to expand the ability of therapeutics to degrade harmful proteins in the body

Booster small molecules re-activate cellular ‘quality control’ machinery of proteasomes, which is impaired in complex diseases

Dr. Patrick Trojer appointed as Chair of the Board of Directors

BERLIN–(BUSINESS WIRE)–Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, launched today with the support of a $15 million financing led by noted life sciences investors Apollo Health Ventures and Novo Holdings. Booster was founded by Dr. Diogo Feleciano, Prof. Dr. Darci Trader, and Apollo Health Ventures, emerging from Apollo’s company creation investment strategy. The company is developing small molecule therapeutics that boost the innate activity of proteasomes to restore the body’s ability to remove a wide range of disease-causing proteins.

“Proteasome activation offers important advantages over more limited conventional protein degradation approaches and provides a powerful lever to combat the effects of the many types of deviant proteins that can accumulate in cells when proteasome function declines through age or disease. The implications for solving major degenerative conditions, such as Parkinson’s and Alzheimer’s, are enormous,” said Dr. Diogo Feleciano, Co-Founder and Chief Scientific Officer. “We’re grateful for the support of our investors, who have enabled us to assemble a world-class team to realize the untapped potential of proteasome activation against a range of difficult-to-treat diseases.”

Proteasomes, the cell’s natural quality control machinery, play a critical role in removing damaged or misfolded proteins. When their function is impaired, misfolded proteins accumulate and increase the risk of serious disease. Booster’s approach is a departure from current targeted protein degradation methods, which tag single disease proteins with the marker protein ubiquitin, leading to their degradation via 26S proteasomes. This can be effective, particularly in diseases driven by a single errant protein. But complex diseases are often driven by multiple protein dysfunctions. To achieve more widespread degradation of unwanted proteins, Booster’s compounds directly activate 20S proteasomes, which naturally recognize disordered proteins without the need for ubiquitin tagging.

“Booster exploits the cell’s universal protein surveillance machinery to drive restoration of protein homeostasis in various disease contexts,” said Dr. Patrick Trojer, Chair of Booster’s Board of Directors and Chief Executive Officer of TRIANA Biomedicines. “The application potential of this therapeutic frontier is highly attractive, and given the broad-spectrum activity of proteasome activators, we see opportunities for both monotherapy and combination approaches where increased proteasome activity may enhance the efficacy of other therapeutics.”

Booster is discovering small molecules through its DGRADX™ platform, which combines proprietary methods for automated high-throughput screening with advanced structural and computational tools. The company has built an extensive library of activator compounds with therapeutic potential and aims to develop a multi-disease pipeline to address proteinopathies.

“Emerging from Apollo’s company creation engine, Booster has made remarkable strides in pioneering this exciting new field of medicine. Booster’s focus on activating the 20S proteasome directly addresses a critical mechanism involved in the cellular stress of aging, offering us a new therapeutic perspective on major disease areas,” said Dr. Marianne Mertens, Partner at Apollo, Managing Director, and Board Member of Booster Therapeutics. “We look forward to working with the team and the strong syndicate to advance toward proof-of-concept and develop a pipeline of potential first-in-class medicines.”

“The pioneering work of Prof. Trader and Dr. Feleciano completely transformed our approach to protein degradation in proteinopathies. Booster’s data support the ability of the 20S proteasome to safely, effectively and specifically degrade a wider set of pathological proteins.” said Dr. João Ribas, Principal at Novo Holdings, Seed Investments and Interim Chief Business Officer and Board Member, Booster Therapeutics. “Proteinopathy is core to many of the most challenging complex diseases, so the potential to address them with a single agent is incredibly promising and could reshape the treatment landscape. We’re excited to join Apollo and help advance this novel therapeutic concept to the clinic.”

About Booster Therapeutics

Booster Therapeutics is pioneering a new class of medicines that activate the cell’s natural quality control machinery to treat a range of complex indications. Booster’s small molecule therapeutics, discovered through the DGRADX™ platform, are designed to directly boost the activity of 20S proteasomes to restore the body’s ability to clear disease-causing proteins. The company is developing a multi-disease pipeline, with an initial focus on neurodegenerative diseases associated with impaired proteasome function such as Parkinson’s disease and Alzheimer’s disease. Booster is based in Berlin, Germany. For more information, visit www.boostertx.com.

About Apollo Health Ventures

Apollo Health Ventures is a transatlantic venture capital firm specialized in developing and investing in data-driven biotechnology and health tech ventures. Apollo Health Ventures invests in game-changing companies at the seed or early stage and builds companies within the aging sector. Apollo’s team consists of entrepreneurs, seasoned biotech investors and scientists with remarkable track records in life science investments and venture creation. www.apollo.vc

About Novo Holdings

Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.

Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S and manages an investment portfolio with a long-term return perspective. Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Principal Investments, Planetary Health Investments and Asia teams, Novo Holdings invests directly in life science companies at all stages of development. In addition, it manages a broad portfolio of Capital Investments, including equities, bonds, fixed income, real estate, and infrastructure assets. As of year-end 2023, Novo Holdings had total assets of EUR 149 billion. www.novoholdings.dk

Contacts

Kit Rodophele

Ten Bridge Communications

617-999-9620

krodophele@tenbridgecommunications.com

Orthofix to Report Third Quarter 2024 Financial Results




Orthofix to Report Third Quarter 2024 Financial Results

Company to Host Conference Call on Thursday, November 7, 2024 at 8:30 am ET

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today announced that it will release its third quarter 2024 financial results on Thursday, November 7, 2024 before market open. The Company will host a conference call and webcast to review results at 8:30 am ET the same day.

Interested parties may access the conference call by dialing (888) 330-2508 in the U.S., and (240) 789-2735 in all other locations, and referencing the event passcode 9556380. A replay of the call will be available for three weeks by dialing (800) 770-2030 in the U.S., and (647) 362-9199 in all other locations, and entering the event passcode 9556380. A webcast of the conference call and a copy of the release may be accessed at ir.Orthofix.com.

Internet Posting of Information

Orthofix routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.orthofix.com. The Company encourages investors and potential investors to consult the Orthofix website regularly for important information about Orthofix.

About Orthofix

Orthofix is a global medical technology company headquartered in Lewisville, Texas. By providing medical technologies that heal musculoskeletal pathologies, we deliver exceptional experiences and life-changing solutions to patients around the world. Orthofix offers a comprehensive portfolio of spinal hardware, bone growth therapies, specialized orthopedic solutions, biologics and enabling technologies, including the 7D FLASH™ navigation system. To learn more, visit Orthofix.com and follow on LinkedIn.

Contacts

Investor Relations
Julie Dewey

JulieDewey@Orthofix.com
209.613.6945

Media Relations
Denise Landry

DeniseLandry@Orthofix.com
214.937.2529

Melt Pharmaceuticals Announces Dosing of Last Patient in Pivotal Phase 3 Study of Its Lead Product Candidate, MELT-300, for Needle- and Opioid-Free Sedation in Patients Undergoing Cataract Surgery




Melt Pharmaceuticals Announces Dosing of Last Patient in Pivotal Phase 3 Study of Its Lead Product Candidate, MELT-300, for Needle- and Opioid-Free Sedation in Patients Undergoing Cataract Surgery

Topline Readout Expected in Q4 2024

FDA Agrees to a MELT-300 Phase 3 Special Protocol Assessment

NASHVILLE, Tenn.–(BUSINESS WIRE)–Melt Pharmaceuticals, Inc. (“Melt”), a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced the dosing of the last patient in its pivotal Phase 3 study evaluating the safety and efficacy of its lead product candidate, MELT‑300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery.

MELT-300 combines fixed doses of midazolam (3mg) and ketamine (50mg) in one tablet that is administered sublingually using Catalent’s proprietary Zydis® delivery technology to dissolve and absorb the active ingredients across the sublingual mucosa rapidly. The MELT-300 Phase 3 clinical trial is a randomized, double-blind, three-arm study comparing, at a 4:1:1 ratio, MELT-300, sublingual midazolam, and sublingual placebo, respectively, for procedural sedation. The study was conducted at 13 clinical sites and enrolled over 525 patients. The topline readout from this study is expected before the end of 2024.

Additionally, Melt today announced that it had reached an agreement with the U.S. Food and Drug Administration (“FDA”) on a Special Protocol Assessment (“SPA”) for the MELT-300 Phase 3 study. FDA agreed the study would “adequately address the objectives necessary to support a regulatory submission.” The SPA agreement establishes a binding agreement on key elements to support a future marketing application. Further, based on its review of results from a recently completed cardiac safety study evaluating the potential risk for a serious drug-induced irregular heart rhythm, the FDA agreed that MELT-300 did not alter normal heart rhythm. A final decision regarding marketing approval will be based on the FDA’s review of the full MELT-300 submission package.

Melt previously announced its MELT-300 Phase 2 clinical trial results in patients undergoing cataract surgery, which compared MELT-300 against (i) sublingual placebo alone, (ii) sublingual midazolam, and (iii) sublingual ketamine in over 300 patients. MELT-300 was statistically superior for procedural sedation compared to all individual comparator arms: (i) sublingual placebo (P<0.0001), (ii) sublingual midazolam (P=0.0129), and (iii) sublingual ketamine (P=0.0096).

In commenting on the announcement, Dr. Larry Dillaha, Chief Executive Officer of Melt, said, “Completing the enrollment in our Phase 3 study and receiving the FDA’s agreement on our SPA are key milestones in the development of MELT-300 as we pursue our mission to provide needle- and opioid-free procedural sedation. We are extremely grateful to the investigators and patients who participated in this pivotal study and are excited to learn and share the findings of the Phase 3 study in the coming weeks.”

Dr. Dillaha added, “To our knowledge, this is the first constructive attempt to advance the standard of care of procedural sedation for cataract surgery patients, affecting the more than 5 million patients estimated to undergo this procedure annually in the U.S. in the coming years. Additionally, we believe success in the MELT-300 Phase 3 study should fuel further development and label expansion, with the potential of allowing MELT-300 to be utilized for procedural sedation in over 100 million annual procedures in areas such as dermatology, plastics, dental, gastrointestinal, and emergency rooms.”

About Melt Pharmaceuticals

Melt Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing proprietary non-IV, non-opioid, sedation, and analgesia therapeutics for human medical procedures in the hospital, outpatient, and in-office settings. Melt intends to seek regulatory approval through the FDA’s 505(b)(2) regulatory pathway for its proprietary, patented small-molecule product candidates, where possible. Melt’s core intellectual property is the subject of multiple granted patents in North America, Europe, Asia, and the Middle East. Melt Pharmaceuticals, Inc. is a former subsidiary of Harrow, Inc. (Nasdaq: HROW) and was carved out as a separately managed business in 2019. To learn more about Melt, please visit their website, www.meltpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are all statements other than those statements of historical facts. No representation or warranty is made as to such statements, all of which involve substantial risks and uncertainties. Actual results could vary materially.

Contacts

Investor Contact:
Larry Dillaha, M.D.

Chief Executive Officer

ldillaha@meltpharma.com

Media Contact:
Deb Holliday

Holliday Communications, Inc.

deb@hollidaycommunications.net
412-877-4519

Renowned Proteomic Researchers to Present Quantum-Si Data at World HUPO 2024




Renowned Proteomic Researchers to Present Quantum-Si Data at World HUPO 2024

BRANFORD, Conn.–(BUSINESS WIRE)–Quantum-Si Incorporated (Nasdaq: QSI) (“Quantum-Si,” “QSI” or the “Company”), The Protein Sequencing Company™, today announced its participation at the Human Proteome Organization (HUPO) World Congress 2024 in Dresden, Germany. As a leader in Next-Generation Protein Sequencing™ (NGPS), Quantum-Si will be joined by prominent researchers to present data showcasing advancements in proteomic analysis.

Quantum-Si’s latest developments, featuring data from Platinum^®, the world’s first and only NGPS instrument on the market, will be highlighted in two key poster sessions:

Poster Presentations:

• Quantum-Si’s Next-Generation Protein Sequencer™ Enables Protein Detection and Peptide Characterization from Biological Samples
  • Presented by John Kudolo, PhD, Quantum-Si
  • Poster ID: P-III-0753 | Date: Wednesday, October 23
• Integrated Sequencing of Single Transcript and Protein Molecules Discerns Alternatively Spliced Tropomyosin Proteoforms
  • Presented by Gloria Sheynkman, PhD, University of Virginia
  • Poster ID: P-III-0758 | Date: Wednesday, October 23

In addition to the poster presentations, Quantum-Si will host a breakfast talk on Tuesday, October 22, titled “Joining Forces: Next-Generation Protein Sequencing™ and Top-Down Mass Spectrometry Combine to Enhance Proteoform Analysis.” The session will be led by Dr. Meredith Carpenter, Quantum-Si’s Head of Scientific Affairs, and Dr. Neil Kelleher from Northwestern University.

These presentations will showcase new data demonstrating how Platinum addresses applications including detection of protein variants and post-translational modifications, protein barcoding, and characterization of proteoforms in tandem with top-down mass spectrometry.

“We are honored to have such accomplished researchers presenting data from Platinum at HUPO 2024,” said Jeff Hawkins, Chief Executive Officer of Quantum-Si. “The ability to detect and characterize proteins and peptides with such depth and precision is a significant step forward for proteomic research. We continue to believe our technology has the potential to transform how scientists approach biological discovery.”

For more information about Quantum-Si’s innovative solutions and to meet the team at World HUPO 2024, attendees can visit booth #24.

About Quantum-Si Incorporated

Quantum-Si, The Protein Sequencing Company^™, is focused on revolutionizing the growing field of proteomics. The Company’s Platinum^® instrument enables Next-Generation Protein Sequencing™ that advances proteomic research, drug discovery, and diagnostics beyond what has been possible with existing proteomic tools. Learn more at quantum-si.com or follow us on LinkedIn or X.

Forward Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. The actual results of the Company may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to future performance and development and commercialization of products and services. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. Most of these factors are outside the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the inability to maintain the listing of the Company’s Class A common stock on The Nasdaq Stock Market; the ability of the Company to grow and manage growth profitably and retain its key employees; the Company’s ongoing leadership transitions; changes in applicable laws or regulations; the ability of the Company to raise financing in the future; the success, cost and timing of the Company’s product development and commercialization activities; the commercialization and adoption of the Company’s existing products and the success of any product the Company may offer in the future; the potential attributes and benefits of the Company’s commercialized Platinum™ protein sequencing instrument and kits and the Company’s other products once commercialized; the Company’s ability to obtain and maintain regulatory approval for its products, and any related restrictions and limitations of any approved product; the Company’s ability to identify, in-license or acquire additional technology; the Company’s ability to maintain its existing lease, license, manufacture and supply agreements; the Company’s ability to compete with other companies currently marketing or engaged in the development or commercialization of products and services that serve customers engaged in proteomic analysis, many of which have greater financial and marketing resources than the Company; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets once commercialized, either alone or in partnership with others; the Company’s estimates regarding future expenses, future revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties described under “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, and in the Company’s other filings with the SEC. The Company cautions that the foregoing list of factors is not exclusive. The Company cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.

Contacts

Investor Contact
Doug Farrell, VP, Investor Relations

ir@quantum-si.com

Media Contact
Katherine Atkinson, SVP, Commercial Marketing

media@quantum-si.com

Gritstone bio Takes Action to Preserve Value and Strengthen Capital Structure




Gritstone bio Takes Action to Preserve Value and Strengthen Capital Structure

Voluntarily Files for Chapter 11 Restructuring

Strategic Alternatives Process Continues with Interest from Parties

EMERYVILLE, Calif.–(BUSINESS WIRE)–Gritstone bio, Inc. (Nasdaq: GRTS) (“Gritstone” or the “Company”), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced it has filed a voluntary petition under chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware.

Gritstone intends to use the court-administered restructuring process to preserve value and support its ongoing strategic alternatives process. The Company is in discussions with a party to act as a stalking horse bidder or plan sponsor and intends to present an agreement to the Court as early as next week in order to enter into a value-maximizing transaction and continue to research and develop its next-generation vaccines and immunotherapies for oncology and infectious diseases.

“Our world-class science and cutting-edge innovations have positioned us at the forefront of oncology and medical breakthroughs. We recently reported encouraging interim Phase 2 data from our ongoing study evaluating GRANITE, which continues to demonstrate an emerging benefit for patients, however, additional time is needed for the data to mature,” said Andrew Allen, MD, PhD, Co-founder, President & CEO of Gritstone. “The decision to file for chapter 11 relief allows us to stay focused on our mission of bringing potentially life-saving treatments like GRANITE to patients around the world.”

During its financial restructuring process, Gritstone intends to operate in the ordinary course and remains committed to advancing its clinical programs, including its ongoing neoantigen immunotherapy and infectious disease programs, and driving innovation in immunotherapy and vaccine development.

Gritstone is filing customary “first day” motions in its chapter 11 case with the intention of ensuring normal operations. Upon court approval of these first day motions, Gritstone intends to minimize the impact of the bankruptcy process on the Company’s vendors, employees, and other key stakeholders.

Additional information regarding Gritstone’s chapter 11 process is available at https://www.veritaglobal.net/gritstone. Stakeholders with questions may call the Company’s Claims Agent, Verita Global, at 877-709-4754 or 424-236-7233 if calling from outside the U.S. or Canada, or send an inquiry by visiting https://www.veritaglobal.net/gritstone/inquiry.

Advisors

Pachulski Stang Ziehl & Jones LLP is serving as legal counsel, Fenwick & West LLP is serving as general corporate counsel, Raymond James & Associates, Inc. is serving as investment banker, PwC is serving as financial advisor, and C Street Advisory Group is serving as strategic communications advisor to the Company.

About Gritstone

Gritstone bio, Inc. (Nasdaq: GRTS) is a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines. We leverage our innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets. Independently and with our collaborators, we are advancing a portfolio of product candidates to treat and prevent viral diseases and solid tumors in pursuit of improving patient outcomes and eliminating disease. www.gritstonebio.com

Gritstone Forward-Looking Statements

This press release contains forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the process and potential outcomes of Gritstone’s chapter 11 case, Gritstone’s ability to continue to operate as usual during the chapter 11 case, Gritstone’s ability to enter into a transaction in the chapter 11 case and strengthen its capital structure, and Gritstone’s ability to present a stalking horse bidder or plan sponsor to the Court. These statements are based on management’s current expectations, and actual results and future events may differ materially due to risks and uncertainties, including, without limitation, risks inherent in the bankruptcy process, including the outcome of the chapter 11 case; Gritstone’s financial projections and cost estimates; Gritstone’s ability to raise additional funds or secure additional financing during the chapter 11 case; Gritstone’s ability to conduct asset sales; the impact of the chapter 11 case on the listing of the Gritstone’s common stock on the Nasdaq Stock Market; and the effect of the chapter 11 case on Gritstone’s business prospects, financial results and business operations. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Gritstone’s most recent Quarterly Report on Form 10-Q filed on August 13, 2024 and any current and periodic reports filed with the Securities and Exchange Commission.

Contacts

Media
C Street Advisory Group

gritstone@thecstreet.com

Glooko Secures $100 Million Series F Financing and Appoints Mike Alvarez as Chief Executive Officer




Glooko Secures $100 Million Series F Financing and Appoints Mike Alvarez as Chief Executive Officer

Expert health tech leader brings extensive experience in connected care, life sciences and chronic condition management to drive global growth

PALO ALTO, Calif.–(BUSINESS WIRE)–Glooko, Inc., a global integrated digital health company connecting patients, providers, biopharma and medical device partners, today announced that it has secured a $100 million Series F financing. The Company’s Board of Directors also announced the appointment of Mike Alvarez as Chief Executive Officer.

The financing round, led by Georgian, with investments from Health Catalyst Capital, Canaan and other investors and business partners, will support Glooko’s continued growth and product expansion in expert data insights, device integrations, clinical research and chronic condition support for healthcare providers around the world. This funding, coupled with the appointment of Mr. Alvarez as CEO, will allow Glooko to accelerate global product expansion of its cutting-edge digital healthcare platform and life sciences work, which empowers people with diabetes to better manage their condition and strengthen the engagement with and care from their healthcare team.

“On behalf of the Board of Directors, we are delighted to welcome Mike Alvarez as the new leader of Glooko,” said Simon Chong, Co-Founder at Georgian and Chairman of the Board of Directors for Glooko. “Today, more than 537 million adults worldwide are diagnosed with diabetes, and the numbers are projected to grow every year. The need for timely, comprehensive and integrated support for healthcare practitioners is critical. Mike brings significant industry expertise, proven leadership and commercial success across chronic condition management and population health, as well as experience with advanced data management technologies. We believe Mike is the right leader at a key inflection point for Glooko and look forward to working with him.”

Mr. Alvarez brings more than two decades of leadership experience with multinational companies in medical devices and biotechnology. Most recently, Mr. Alvarez served as Chief Executive Officer of Qardio, a leader in remote patient monitoring and technology solutions for chronic disease management. Prior to Qardio, Mr. Alvarez held leadership positions at Medtronic, St. Jude Medical (acquired by Abbott), and Sanofi.

“The healthcare industry is currently navigating significant challenges related to data burden and clinical workflows, particularly for physicians working with patients to manage chronic conditions,” said Mr. Alvarez. “By unifying data from multiple devices onto one standardized platform, we can simplify decision-making and empower providers to translate vast amounts of data into meaningful insights. This enables timely interventions and helps create new clinical care pathways that can enhance patient outcomes. I am thrilled to join Glooko at this pivotal moment in its journey. I look forward to continued commercial acceleration as we leverage real-world data to transform chronic condition management and improve enrollment and management in clinical trials through diverse and inclusive populations.”

About Glooko

Glooko improves health outcomes of people with chronic conditions through its personalized, intelligent, connected care and life sciences platform. Our proven technologies make lives better by revolutionizing the connection between patients and providers, driving patient engagement and adherence via digital therapeutics, and accelerating the speed of clinical trials. More than 4.4 million people around the world with diabetes have used the Glooko platform. For more information, please visit our website.

About Georgian

Georgian invests in high-growth B2B software companies and builds software to help those companies scale faster through our AI Lab. We seek to identify and accelerate leading growth-stage software companies in our thesis areas of Applied AI and Trust. Based in Toronto, Georgian’s team brings together investors with machine learning professionals, software entrepreneurs and experienced operators. Founded in 2008, Georgian has US$5.6B AUM as of December 31, 2023.

Contacts

Media Inquiries:

Liz Horgan

Chief Marketing Officer

Glooko

pr@glooko.com

Julia Fuller

Managing Partner

Ford Hutman Media

julia@fordhutmanmedia.com

James Lamberti

Head of Go to Market

Georgian

james@georgian.io

BenevolentAI to Present on Explainable AI for Drug Discovery at BioTechX Europe 2024




BenevolentAI to Present on Explainable AI for Drug Discovery at BioTechX Europe 2024

LONDON–(BUSINESS WIRE)–BenevolentAI (“BenevolentAI” or the “Company”) (Euronext Amsterdam: BAI), a leader in applying advanced AI to accelerate biopharma drug discovery, announces that Dr James Malone, Chief Technology Officer, will hold a presentation titled “Building Trust and Explainability in using AI in Drug Discovery” at BioTechX Europe in Basel on 10 October 2024 at 11:45 AM CET. The presentation will discuss how explainable artificial intelligence can increase transparency in drug discovery, focusing on BenevolentAI’s innovative R2E (Retrieve to Explain) system.

At the event, Dr Malone will illustrate the capabilities of R2E, which combines AI-driven information retrieval with explainable predictions to enhance drug target identification. The system integrates diverse biomedical data, including scientific literature, genomics, and clinical information, with AI algorithms to prioritise drug targets. By processing complex queries across the human genome and providing detailed explanations for its predictions, R2E enables researchers to make more informed decisions based on AI-generated insights.

Dr Malone will present data comparing R2E’s performance against traditional approaches in predicting clinical trial outcomes. Specifically, when utilising all data modalities, R2E demonstrated a higher relative success rate in identifying promising drug targets compared to industry-leading genetics-based methods. These performance improvements demonstrate R2E’s potential to significantly impact the drug discovery process, particularly in the critical areas of target identification and clinical trial success prediction.

Dr Malone’s presentation follows his participation in the event’s Keynote Panel, “The benefits of AI within drug discovery”. The panel featured speakers including Hebe Middlemiss (Head of AI Strategy and Innovation, AstraZeneca), Venkatesh Moktali (Global Product Manager, QIAGEN), Daniel Kuhn (Director, Head of AI and New Technologies, Merck), Bulent Kiziltan (Vice President and Global Head of AI & Computational Sciences, Novartis). The panel was moderated by BenevolentAI’s Chief Business Officer & Co-Founder, Dr Ivan Griffin.

Category: Non-regulatory

About BenevolentAI

At BenevolentAI (AMS: BAI), we serve patients by leveraging our proprietary and validated Benevolent Platform™ that integrates AI and science to uncover new biology, predict novel targets and develop first-in-class or best-in-class drugs for complex diseases. By applying proprietary advanced AI tools, in combination with in-house scientific expertise and wet-lab facilities, BenevolentAI is well-positioned to identify and accelerate novel drug discovery.

The Company’s business model presents multiple routes for value creation including discovery collaborations with pharma companies like AstraZeneca and Merck and advancing in-house pipelines to inflection points. Headquartered in London, with wet labs in Cambridge (UK), BenevolentAI is at the forefront of reshaping the future of drug discovery and delivering innovative medicines.

Contacts

Investors:
Fleur Wood – VP Investor Relations

investors@benevolent.ai

Media:
James Osborn – Communications Lead

press@benevolent.ai

ICR Consilium:
Amber Fennell / Jessica Hodgson / Ashley Tapp

T: +44(0) 203 709 5700

BenevolentAI@icrinc.com

Deutsche Numis:
Freddie Barnfield / Euan Brown / Peter Davis / Michael Palser

T: +44 207 260 1000

dbnumis_BenevolentAI@dbnumis.com

TheraCom Pharmacy Substitute Notice of Data Incident to Affected Individuals




TheraCom Pharmacy Substitute Notice of Data Incident to Affected Individuals

CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–TheraCom Pharmacy (“TheraCom”) is issuing a substitute notice to individuals who may have been impacted by a data security incident. TheraCom’s parent company previously announced the data security incident, which is fully contained.

An investigation with the assistance of law enforcement, cybersecurity experts and outside lawyers has now identified certain patients of TheraCom whose personal information was involved in the incident. TheraCom maintained this information for purposes of distribution of prescription medication, often at no charge, to individuals enrolled in patient assistance programs. In some instances, TheraCom does not have addresses for the individuals involved. Accordingly, TheraCom is issuing this press release. The personal information involved included first name, last name, address, date of birth, prescription information, medical treatment information, medical history, health insurance information, Medicare/Medicaid number, and/or medical record number. There is no evidence that any of this information has been or will be publicly disclosed, or that any information was or will be misused for fraudulent purposes as a result of this incident.

For individuals seeking additional information regarding this event, a toll-free assistance line has been established. Individuals may call 1-833-918-8818 toll-free Monday through Friday from 9 am – 9 pm US Eastern Time.

Potentially affected individuals can also find additional information on how they can help protect their personal information, as well as obtain additional resources, and other information, by visiting TheraCom’s website at https://www.amerisourcebergen.com/theracom.

TheraCom takes this incident and the security of information entrusted to it very seriously. TheraCom is working with cybersecurity experts to reinforce its systems and information security protocols in an effort to prevent incidents like this from occurring in the future.

Contacts

Mike Iorfino

610.545.9189

mike.iorfino@cencora.com

Abalos Therapeutics Appoints Gerben Moolhuizen as Chief Executive Officer




Abalos Therapeutics Appoints Gerben Moolhuizen as Chief Executive Officer

— Experienced biopharma executive will lead the company’s transition into the clinic, with initiation of the first-in-human trial for lead program ABX-001 in solid tumors in 2025 —

DÜSSELDORF, Germany–(BUSINESS WIRE)–#Abalos—Abalos Therapeutics announced today the appointment of Gerben Moolhuizen, MBA, as Chief Executive Officer. Mr. Moolhuizen brings an impressive track record in drug development and a wealth of experience spanning over three decades across a diverse array of fields and technologies in the biopharmaceutical industry. Abalos is currently advancing ABX-001, the first candidate from its proprietary AdaptInnate platform, towards clinical evaluation. ABX-001 is a novel immunostimulatory product candidate that is delivered systemically and aims to trigger a tailored immune reaction from inside the tumor to release the full breadth of the immune response against solid tumors, including distant metastases.

“Gerben’s extensive operational and strategic drug development expertise makes him uniquely qualified to lead Abalos as we transition to a clinical-stage biotechnology company, executing our clinical strategy and expanding our platform capabilities,” commented Dr. Klaus Binder, Chairman of the Board of Abalos. “We welcome Gerben to the Abalos team and look forward to working together to unlock the vast potential of this novel therapeutic approach bringing together both the innate and adaptive arms of the immune system to trigger a concerted anti-tumor response. I would also like to extend our gratitude to Dr. Marcus Kostka for his exemplary leadership in translating a unique scientific idea into a promising product candidate that has successfully advanced through preclinical evaluation.”

“Abalos’ approach to harness the immunostimulatory properties of arenaviruses specifically against tumor cells is highly differentiated in the immuno-oncology field,” said Gerben Moolhuizen, Chief Executive Officer of Abalos. “The company has already achieved several key milestones in building out a completely new technology and has a lead product candidate nearing first-in-human evaluation. I am excited to join Abalos’ innovative and outstanding team to bring a differentiated treatment option to solid tumor patients.”

Prior to joining Abalos, Mr. Moolhuizen held several leadership positions in biotech and the pharmaceutical industry including Chief Executive Officer and Chief Business Officer at ISA Pharmaceuticals, General Manager at OctoPlus, which got acquired during his tenure by Dr. Reddy’s Laboratories Ltd. in 2013, and business development roles at Pharming Group. In these positions he was closely involved in all corporate development aspects across the biotech life cycle encompassing therapeutic product development, fundraising activities, IPO processes and acquisitions. Gerben Moolhuizen holds an M.Sc. from Utrecht University in Medical Biology and an MBA from Erasmus University Rotterdam.

Abalos is leveraging its proprietary AdaptInnate technology platform to develop a new class of product candidates harnessing the immunostimulatory and anti-tumoral properties of arenaviruses to trigger a highly precise and directed immune response against primary tumors and their metastases. Abalos’ lead candidate, ABX-001, is specifically designed to persist and replicate in cancerous and antigen-presenting cells without destroying them. This novel, non-oncolytic approach results in the induction of targeted, effective, and durable anti-tumor activity involving both the innate and adaptive arms of the immune system. In preclinical studies, the candidate has shown marked tumor regression in multiple tumor models, its ability to induce tumor-specific T cells, as well as an excellent pre-clinical safety profile in non-human primates. In addition, a robust and scalable cGMP manufacturing process, which allows for manufacturing at high yield, has been established. Based on these promising results, Abalos is currently preparing the initiation of a first-in-human clinical trial with its lead candidate in patients with solid tumors, which is expected to start in 2025.

About Abalos Therapeutics

Abalos Therapeutics is pioneering a novel anti-cancer approach that directs the full breadth of the immune system’s power specifically towards cancer cells. Abalos’ arenavirus-based drug candidates are designed to trigger precise innate and adaptive immune responses from within the tumor to engage all relevant immune cell types in a concerted attack against both the primary tumor and distant metastases. The company’s lead product candidate ABX-001 has demonstrated strong anti-tumor efficacy in pre-clinical studies in multiple tumor models as well as an excellent pre-clinical safety profile and will enter the clinic in 2025. Led by experienced biotech entrepreneurs and immunology pioneers, Abalos’ goal is to establish a new drug class in immuno-oncology. For more information, please visit www.abalos-tx.com.

Contacts

Abalos Therapeutics GmbH
Phone: +49 211 540104-0

Email: info@abalos-tx.com

Abalos media inquiries
Trophic Communications

Stephanie May / Marie-Theresa Weickert

Phone: +49 171 185 56 82

Email: abalos@trophic.eu

Anavo Therapeutics Appoints Dr. Edward Holson as Chief Scientific Officer and President US




Anavo Therapeutics Appoints Dr. Edward Holson as Chief Scientific Officer and President US

LEIDEN, Netherlands–(BUSINESS WIRE)–Anavo Therapeutics, a global leader in unlocking the full therapeutic potential of phosphatase biology, today announced the appointment of Edward Holson, Ph.D., as Chief Scientific Officer (CSO). Based in Boston, he will also serve as President of Anavo US, overseeing R&D operations both in the US and Europe. The dual presence will enable Anavo to leverage both research team’s complementary scientific strengths across leading biotechnology regions. Dr. Holson brings over 25 years of expertise in medicinal chemistry, drug discovery, and novel therapeutic development. As an accomplished scientific leader, Dr. Holson has co-founded and led several biotech ventures, directing drug discovery efforts and developing small-molecule therapies across various indications, biological targets and technologies. In his role, he will drive Anavo’s scientific strategy, focusing on advancing the company’s proprietary IGNITE platform and the development of first-in-class phosphatase modulators.

“Anavo Therapeutics is advancing a critical area of drug discovery by targeting phosphatases with strategies that unlock the specific regulation of this important enzyme class. The team has built a strong foundation using the proprietary IGNITE platform, designed to modulate phosphatase signaling pathways and develop therapies that address complex diseases. My focus will be on working with the entire Anavo team to drive the development of novel therapies that target previously undruggable phosphatase signaling pathways, addressing critical needs in immunology, metabolism, oncology and other complex diseases,” stated Dr. Edward Holson, Chief Scientific Officer, President US of Anavo Therapeutics.

“As we continue to generate key data demonstrating the potential of our IGNITE platform, Ed’s expertise in medicinal chemistry and drug discovery is a timely addition. His extensive background in leading small-molecule programs will be instrumental in advancing our pipeline of phosphatase modulators. We look forward to leveraging his network in the U.S. to expand our global reach and accelerate our proprietary programs targeting disease-relevant phosphatases toward clinical development. We also extend our gratitude to Shaun McNulty for his contributions to Anavo and wish him the best in his future endeavors,” said Dr. Birgit Zech, Chief Executive Officer of Anavo Therapeutics.

Dr. Edward Holson is a distinguished scientist and entrepreneur with over two decades of experience in medicinal chemistry, drug discovery, and therapeutic development. Before joining Anavo, he co-founded Photys Therapeutics, serving as Chief Scientific Officer and Strategic Advisor. He previously held the roles of President and Chief Scientific Officer as a co-founder at Amathus Therapeutics. He was also the founder of KDAc Therapeutics, where he served as Director, President, and Chief Scientific Officer, and continues to serve on its Board of Directors. He was a founding member of the Scientific Advisory Board at Rodin Therapeutics and served as an Entrepreneur-in-Residence at Atlas Venture. His academic tenure includes serving as Director of Medicinal Chemistry at the Stanley Center for Psychiatric Research and Director of the Chemistry and Chemical Biology Platform at the Broad Institute of MIT and Harvard. Earlier in his career, Dr Holson worked at Infinity Pharmaceuticals and Merck & Co., Inc., Rahway, N.J., USA in various roles in medicinal chemistry and pharmaceutical development.

About Anavo Therapeutics:

Anavo Therapeutics is at the forefront of phosphatase-based drug discovery with its IGNITE platform, a unique approach for accessing a space previously considered undruggable. Based on our world-leading expertise in phosphatase-driven disease biology and drug discovery, we will unlock the full therapeutic potential of phosphatase-targeted modulators for our first-in-class proprietary pipeline and through partnerships. Anavo is backed by blue-chip investors M Ventures, an affiliate of Merck KGaA, Darmstadt, Germany, INKEF Capital, Taiho Ventures, MRL Ventures Fund, and Bioqube Ventures. For more information, please visit: www.anavotx.com.

Contacts

Anavo Therapeutics
Dr. Birgit Zech

Chief Executive Officer

+49 179 5340884

bzech@anavotx.com

Trophic Communications
Dr. Alison Opalko and Dr. Jacob Verghese

+49 151 74416179

anavo@trophic.eu