Societal CDMO Announces Signing of Multiple Agreements With New and Existing Customers

Company Further Diversifies Customer Base with New Clients, Expands Scope of Work with Current Customers

SAN DIEGO and GAINESVILLE, Ga., Sept. 29, 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 multiple CDMO service agreements with both new and existing customers. The new contracts are focused on a range of analytic method, tech transfer, formulation, manufacturing and packaging services designed to support ongoing clinical development programs, as well as planned commercial activities.

The first contract is focused on supporting a new Societal CDMO customer’s preparations for development and commercial manufacturing of its novel attention-deficit/hyperactivity disorder (ADHD) treatment upon regulatory approval. The product uses a unique delivery system combining immediate release and sustained release formulations of the active ingredient in a single, oral tablet. Under terms of the contract, Societal CDMO will conduct tech transfer, manufacturing of engineering and registration batches, and packaging of the final product. Due to the complex formulation and manufacturing requirements for this product, Societal CDMO will dedicate a specific manufacturing suite within its Gainesville, Georgia, facility and outfit it with customer-supplied proprietary equipment.

As part of the second new agreement, Societal CDMO will conduct a range of activities supporting a new customer’s ongoing development of multiple novel topical therapies for inflammatory dermatological and neuropathic pain conditions. The services provided by Societal CDMO will include analytic development, manufacturing, filling, packaging/repackaging and labeling of clinical trial material, both active and placebo, for use in planned clinical studies. This work will span three different development programs for three unique topical therapies.

“These latest contract wins further drive the impressive increase in new business backlog we are generating for the company. The efforts of the business development group, working side by side with the entire Societal CDMO team, are helping the company to continue to significantly diversify its customer base, which allows us to play an ever expanding role in bringing important medicines to patients,” said David Enloe, chief executive officer of Societal CDMO. “While new customer wins are key to our business development strategy, we are also focused on growing revenue by expanding the scope of work with our current customers. This is exemplified by our newly signed agreements, which include a contract to provide additional tech transfer work for one of our existing clients for whom we are already conducting a tech transfer of a different product within their portfolio.”

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.