SCTL Societal CDMO Inc

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 new project expansion agreements with several existing customers. The six new scopes of work across four different current customers highlight Societal’s ability to drive revenue growth through the ongoing strengthening and maturation of existing relationships.

The recently signed work expansion agreements include:

• Increasing the batch size for an ongoing design of experiments (DoE) study of an approved chemotherapeutic agent, with incorporation of additional blending and compaction specifications for the tablets.
• Execution of surrogate batch manufacturing and testing for an approved chemotherapeutic agent, as well as manufacturing of a development batch for a coating DOE study of the same compound.
• Analytical method development and validation, along with clinical trial material batch manufacturing of a fixed-dose combination of an approved chemotherapeutic agent and a compound that enhances the chemotherapeutic agent’s bioavailability and systemic exposure.
• Broadening of clinical trial services related to a U.S.-based Phase 2 clinical study of a novel melatonergic antidepressant already approved for use in Europe and Australia. The expanded activities will focus on over-labeling on both placebo and active bottles under cGMP conditions to support expiry extension.
• Dissolution testing on a prototype development batch of a novel multiparticulate-filled formulation of an investigational compound being developed for the treatment of a range of neurodegenerative diseases. This expanded scope of work also includes the preparation of up to five additional prototype batches of immediate release (IR) formations of the drug candidate, including a range of in-process tests on each IR batch.
• Dissolution testing on engineering batches of an approved anticancer therapeutic, as well as assay testing on engineering and process performance qualification batches.

“This recent flurry of work expansion agreements with several of our existing customers is a strong indication of the momentum that our business development, project management and operations teams continue to generate despite the challenging financial dynamics that are broadly impacting the drug development industry,” said David Enloe, chief executive officer of Societal CDMO. “We take great pride in these work expansions as they not only contribute to growing our revenue but also demonstrate the trust that we are able to build with customers once they are engaged with the Societal organization. Equally impressive is the wide range of CDMO services covered by these agreements across myriad therapeutic areas, highlighting the breadth of capabilities and expertise we possesses throughout our bi-coastal operations.”

About Societal CDMOSocietal 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 StatementsThis 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.

Contacts
Stephanie Diaz (Investors)
Vida Strategic Partners
(415) 675-7401
sdiaz@vidasp.com

Tim Brons (Media)
Vida Strategic Partners
(415) 675-7402
tbrons@vidasp.com

Ryan D. Lake (CFO)
Societal CDMO
(770) 531-8365
ryan.lake@societalcdmo.com