Societal CDMO Announces Signing of Multiple New CDMO Service Agreements
Agreements Showcase Company’s Ability to Support Novel Therapeutic Programs Regardless of Development Stage; Services Focused on Both Preclinical and Last Clinical-Stage Programs
SAN DIEGO and GAINESVILLE, Ga., Oct. 20, 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. These contracts are focused on a range of analytical method, technical transfer, formulation, manufacturing and packaging services designed to support ongoing development programs for novel therapeutic candidates.
Under terms of the first new contract, Societal CDMO will provide services to support the ongoing clinical development of a modified release, bead-filled capsule formulation of an oral biologic indicated for pancreatic insufficiency. This range of services will include analytical method development and validation, technical transfer combined with formulation optimization, clinical trial batch manufacturing, and primary packaging for the drug, which is already approved in Canada. Societal CDMO’s activities will support a planned Phase 3 clinical trial as part of the customer’s ongoing clinical development program for the drug in the United States.
As part of the second agreement, Societal CDMO will conduct a range of activities supporting a new customer’s development of a novel interleukin-2 (IL-2) analog for the treatment of cancer. The services provided by Societal CDMO will include formulation development, analytical method transfer and verification, and GMP batch manufacturing and fill/finish related to the program, which is currently in preclinical development.
“These new contract wins help continue to grow our business while further diversifying our customer base. In particular, our support of the late clinical-stage oral biologic program has the potential to contribute to an increase in our commercial revenues, and is also evidence of the strong reception that our Clinical Trial Services offerings are receiving from drug developers,” said David Enloe, chief executive officer of Societal CDMO. “We are grateful for the trust that these new customers have placed in our team to support the development of their innovative drug candidates. We look forward to delivering an exceptional experience that exceeds their expectations.”
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.
CONTACT: 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
