SAN DIEGO and GAINESVILLE, Ga., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; NASD: SCTL), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has signed CDMO service agreements with two new customers. The new contracts are focused on a range of analytic method, formulation and manufacturing activities designed to support the companies’ respective clinical development programs, including planned clinical trials.
Under terms of the first new contract, Societal CDMO will conduct analytic method activities to support the development of novel multiparticulate-filled immediate and extended release capsule formulations of an investigational compound the customer is developing for the treatment of a range of neurodegenerative diseases. Following completion of the initial analytical method and formulation activities, Societal will execute cGMP manufacturing of clinical trial material, as well as packaging and labeling, to support planned Phase 1 studies involving the immediate and extended release formulations.
As part of the second new agreement, Societal CDMO will conduct analytic method validation and verification, and formulation development for a topical gel drug candidate the customer is developing to combat hair loss. Following completion of the initial analytical method and formulation activities, Societal will execute cGMP manufacturing of clinical trial material, both active and placebo, as well as packaging and labeling, to support planned Phase 1/2a studies involving the investigational drug candidate.
“We are continuing to see a high level of demand for our CDMO services and our business development team is generating significant momentum converting these opportunities into signed contacts with new customers. In just the past several weeks we have announced agreements with five new customers and we are presently engaged with a number of other prospective clients on a range of active proposals,” said David Enloe, chief executive officer of Societal CDMO. “We believe that customers are responding well to our high-quality service offerings in combination with the customized, high-touch manner that we engage with all of our clients. We look forward to supporting our two new customers and their exciting clinical-stage programs with the goal of assisting them in delivering important products to patients in need.”
About Societal CDMO
Societal CDMO (NASDAQ: SCTL) is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.
Societal CDMO: Bringing Science to Society. For more information about Societal CDMO’s customer solutions, visit societalcdmo.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words “anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect,”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that could cause the company’s actual outcomes to differ materially from those expressed in or underlying these forward-looking statements include risks and uncertainties associated with the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the customer ordering patterns or inventory rebalancing or disruption in raw materials or supply chain; demand for the company’s services, which depends in part on customers’ research and development and the clinical plans and market success of their products; customers’ changing inventory requirements and manufacturing plans; customers and prospective customers decisions to move forward with the company’s manufacturing services; the average profitability, or mix, of the products the company manufactures; the company’s ability to enhance existing or introduce new services in a timely manner; fluctuations in the costs, availability, and suitability of the components of the products the company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials, or the company’s customers facing increasing or new competition. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results presented herein along with those risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.
