Weekly Quick Hits (Research Triangle Park) – Week of August 7, 2023
While the economy has slowed momentum for a number of RTP-based life sciences organizations, including a few bankruptcy filings earlier this summer, several companies are eying near-term growth, including Chiesi and Clinetic. Milestone Pharmaceuticals is also on the cusp of new growth, which could follow a planned Q3 NDA for its experimental PSVT treatment.
By Alex Keown
August 11, 2023
Funding, Awards and Collaborations
Aceragen, Inc. to Delist from The Nasdaq Stock Market
Durham’s Aceragen intends to voluntarily terminate the listing of its common stock on the Nasdaq Capital Market on or about Aug. 15, 2023. As previously disclosed, on Aug. 14, 2023, the company expects to hold a special meeting seeking stockholder approval to effect a transfer and assignment of substantially all of the company’s assets to an assignee for the benefit of creditors.
Kohlberg to acquire majority stake in Worldwide Clinical Trials
An affiliate of private equity firm Kohlberg will acquire a majority stake in RTP-based Worldwide Clinical Trials, a full service contract research organization. TJC, another private equity firm, is the current majority owner of Worldwide. The transaction is expected to close in the fourth quarter of 2023, subject to regulatory approvals and customary closing conditions. The terms of the transaction are not disclosed.
Javara, Nevada Health Centers Plan to Bring Clinical Research to Medically Underserved
N.C.-based Javara, a leading integrated research organization (IRO) focused on delivering access to clinical trials at the point of care, announced a strategic partnership with Nevada Health Centers to embed clinical research professionals within NVHC clinics to work alongside physicians and medical staff and provide all aspects of operational collaboration to deliver clinical trials as a care option to their patients. The immediate focus of this new partnership is the Reno and Carson City locations. Javara and NVHC anticipate activation of the first clinical trials in internal medicine in the fall of 2023.
Bioventus Lowers Debt, Strengthens Financial Position in Second Quarter
Bioventus Inc. posted net sales of $137.1 million, down $3.3 million, or 2.3%, during the second quarter of 2023. During the quarter, the company closed the sale of its wound business. The $31 million in proceeds were used to repay debt. In total, Bioventus paid down its debt by $60.3 million during the quarter. As of July 1, 2023, Bioventus had $29.4 million in cash and cash equivalents and $385.9 million in debt obligations. At the end of 2022, the company had $30.2 million in cash and cash equivalents and $418.1 million in debt obligations.
Bookings Up, Revenue Down for Science 37
Science 37 Holdings saw a 33% increase in gross bookings during the second quarter of 2023, valued at $38.2 million. Revenue during the quarter was $15.4 million, a 20% decrease compared to the same period in 2022. The company reported cash and cash equivalents of $65 million as of June 30, 2023.
Clinetic Closes Series A Funding Round Led by Sopris Capital
Clinetic, a Duke University health tech company focused on streamlining clinical research, announced the close of its Series A financing round led by Sopris Capital, a venture capital firm focused on technology-enabled healthcare solutions. The undisclosed financing will enable Clinetic to accelerate its patient recruitment and real-world data capabilities, deepen the company’s relationships with its network of data-connected health systems, and support collaborations with a growing number of life science customers.
Thermo Fisher Scientific Selected as T-SCCC for NIAID
The N.C.-based PPD clinical research business of Thermo Fisher Scientific was granted a five-year award to provide a Transplantation Statistical and Clinical Coordinating Center for the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in the United States. This center will offer a broad range of support services critical to the design, development, execution and analysis of NIAID transplantation clinical trials and research, including statistical design and analysis; clinical protocol development, implementation and study management, and more.
Chiesi Group Sees Strong Growth in 2023
Chiesi USA, a Cary-based specialty pharmaceutical company, announced the group continues to experience major growth in 2023. The group’s 2023 sales for the first half of the year are at €1.497 billion, representing a growth of 12% compared with 2022. Despite economic and geopolitical challenges, Chiesi’s performance remains very strong. In 2023, the Group anticipates revenues of about €3 billion with projected further growth in 2024. Solid profitability, with substantial cash generation, gives Chiesi the opportunity for future inorganic growth.
Marius Pharmaceuticals Partners with Smartway to Manage Program for Kyzatrex
Raleigh-based Marius Pharmaceuticals and Smartway Pharmaceuticals announced a strategic partnership, aimed at addressing the pressing global issue of hypogonadism through the launch of a comprehensive Early Access Program for Kyzatrex (testosterone undecanoate). Hypogonadism, a prevalent medical condition affecting millions of men worldwide, is characterized by low testosterone levels, which can lead to a range of comorbidities, including obesity, type 2 diabetes, depression, and cardiovascular disease.
In the Clinic
EmitBio to Present Research on Novel Light-Based Antiviral Therapy
RTP-based EmitBio Inc. will present findings from the Phase II clinical study of its RD-X19 treatment device in individuals with mild-to-moderate COVID-19 at the World Congress on Infectious Diseases in October. The company will share data from the study assessing its novel light-based therapy RD-X19, an investigational handheld, self-administered medical device. The RD-X19 delivers precise doses of high energy blue light to the posterior oropharynx and surrounding tissues. The device was well-tolerated and showed promising results in improving symptomatic relief, particularly in subjects aged 40 years and above with mild COVID-19, data showed.
AskBio Doses First Patient in Phase I/II LGMD Gene Therapy Study
Asklepios BioPharmaceutical (AskBio), a gene therapy subsidiary of Bayer AG, dosed the first patient in the Phase I/II LION-CS101 clinical trial of patients with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). AB-1003 is a novel investigational FKRP gene replacement therapy. LGMD2I/R9 is a form of LGMD caused by changes in the FKRP gene and is associated with weakness and wasting of arm and leg muscles.
Milestone Pharmaceutical Eyes October NDA for PSVT Treatment
In its quarterly financial report, N.C.-based Milestone Pharmaceuticals announced it expects to submit its first NDA for etripamil, the company’s investigational calcium channel blocker that is administered by patients outside of the healthcare setting, in patients with PSVT in October. Based on feedback from the FDA, data from the Company’s previously completed global Phase III clinical program, including the RAPID and RAPID-extension studies, NODE-303 and NODE-301, are expected to fulfill the safety and efficacy requirements for the planned NDA submission.
Real Estate
GSK Sells 70 acres to Homebuilder
A new residential community is being planned near GSK’s Zebulon facility after the pharmaceutical company sold a large piece of land. An LLC addressed to Ten Oaks Homes, a Maryland custom homebuilder, bought about 70 acres for $2.4 million, Triangle Business Journal reported, citing Wake County deed records. GSK acquired the land in the early 1980s.
Research Roundup
Loneliness Linked to Insomnia Symptoms in Middle-Aged and Older Adults
Feeling lonely can lead to sleepless nights for middle-aged and older adults. A study conducted by researchers from the New York University Rory Meyers College of Nursing and Duke University School of Nursing found a significant link between loneliness and insomnia symptoms, such as difficulty falling and staying asleep, waking up too early in the morning, and nonrestorative sleep. The study was published in the July issue of Psychiatry Research.
NIH: Limiting Sugary Drinks at Home Cuts Childhood Sugar Consumption
Researchers with NIH’s Environmental influences on Child Health Outcomes (ECHO) Program found that limiting access to sugary drinks just in the home could reduce overall consumption of these beverages by as much as 87%. ECHO researchers used computer modeling to simulate interventions and measure their impact on reducing consumption in different populations. The study examined data from children ages 2 to 7 years in three ECHO research sites across the U.S. These children spent time in different environments—home, childcare, and school—where they had varying access to sugary beverages.
Synthetic Antibiotic Could be Effective Against Drug-Resistant Superbugs
Duke University researchers found a new antibiotic strategy to defeat gram-negative bacteria like Salmonella, Pseudomonas and E. coli. The synthetic molecule works fast and is durable in animal tests. The compound, called LPC-233, is a small molecule that has “proven effective at wrecking the outer membrane lipid biosynthesis in every gram-negative bacterium it was tested against.” Researchers tested it against a collection of 285 bacterial strains, including some that were highly resistant to commercial antibiotics, and it killed them all. It works by interfering with a bacterium’s ability to make its outer lipid layer, its skin, so to speak.
Gut Microbiome can Increase Risk, Severity of HIV, EBV Disease
The bacteria and other microbes in our gut play a supporting role in immunity, metabolism, digestion, and the fight against “bad bacteria” that try to invade our bodies. New research from UNC published in Nature Biotechnology revealed that the microbiome may not as always be protective against human pathogens. Using a first-of-its-kind precision animal model with no microbiome (germ-free), researchers have shown that the microbiome has a significant impact on the acquisition of Epstein-Barr virus (EBV) and human immunodeficiency virus-1 (HIV) infection and plays a role in the course of disease. Read more here.
People on the Move
Ten63 Therapeutics Names Steve Hall as Independent Director
Ten63 announced the election of Steve Hall to its board of directors. Hall retired as a Partner at LV Management Group (Lilly Ventures) after 12 years. Hall was a Series A investor in Kymera and Nimbus, companies that, similar to the goals of Ten63, seek to bring to clinical proof of concept small molecule drugs discovered through new modalities.
New AskBio CEO Looks for Growth Opportunities
AskBio CEO Gustavo Pesquin, who was tapped to helm the company in March, is eyeing potential acquisitions of companies struggling to raise financing, the Triangle Business Journal reported. Pesquin shared his strategic thinking in an interview with the Journal. He said the company is “taking a fresh look at all of the opportunities that have been created, particularly in an environment in which many companies have probably attracted capabilities or businesses, and have struggled to get the proper funding to continue their operations.”
KBI Biopharma, Inc. Continues to Strengthen Leadership With Key Appointments
Durham-based KBI Biopharma announced four recent executive appointments to continue its momentum and vision of becoming a next-generation CDMO. Joining the company are Tony Fraij, Chief Operating Officer; Shaguna Seth, Chief of Staff and Global PMO Leader; Katie Edgar, Senior Vice President of Corporate Strategy and Alliance Management; and Sarah Wakefield, Senior Vice President, Corporate Communications. More information about the new executives can be found here.
