Societal CDMO Adds Three New Customers, Signing Agreements to Provide CDMO Services Supporting Clinical Development of Several Novel Therapeutic Candidates

Rhea-AI Summary

Societal CDMO, Inc. (NASDAQ: SCTL) has secured CDMO service contracts from three new clients, enhancing its offerings in clinical trial services, formulation development, and cGMP manufacturing. Key activities include supporting a Phase 2 clinical study for a melatonergic antidepressant, developing a liquid formulation for pediatric neurological diseases, and conducting clinical trial services for a novel cancer treatment. These agreements highlight the company's growth momentum and its critical role in drug development.

Positive

• Secured three new CDMO service contracts, expanding client base.
• New contracts include clinical trial services, a key growth driver.
• Participation in Phase 2 clinical studies for novel treatments boosts business development.

Negative

• None.

Contracted Activities Touch Upon Broad Range of Societal’s Offerings from Clinical Trial Services to Formulation Development to cGMP Manufacturing

Work to be Conducted Collaboratively at Societal’s East and West Coast Facilities

SAN DIEGO and GAINESVILLE, Ga., Aug. 04, 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 been awarded CDMO service contracts from three new customers. The agreements span a range of the company’s offerings including clinical trial services, analytical method and formulation development, and cGMP manufacturing, among others.

“Societal CDMO’s business development team, in conjunction with our technical subject matter experts, has been extremely active in 2022, helping to create significant momentum for our focused efforts to expand our client base and grow our business. The clearest example of this success to date is the recent flurry of new customers wins that we are announcing today,” said David Enloe, chief executive officer of Societal CDMO. “These new agreements spotlight the full range of services that Societal CDMO provides its customers, starting with efforts in the areas as analytical method and process development, as well as formulation design, and advancing into cGMP manufacturing, packaging, labeling and distribution. Importantly, two of these new agreements involve our clinical trial services business, which we view as a key driver of growth for the company. I would like to acknowledge the hard work of our entire team and the excellent results they continue to produce.”

Under terms of the first new contract, Societal will execute a range of clinical trial services to support the initiation of a U.S.-based Phase 2 clinical study of a novel melatonergic antidepressant already approved for use in Europe and Australia. Societal will be responsible for sourcing and preparing the study drug and matching placebo for use in the trial. Additional activities will include packaging and labeling of study drug and matching placebo, as well as storing the prepared materials and distributing them to clinical trial sites within the U.S. These activities will be conducted in collaboration at Societal’s CDMO facilities in Georgia and California.

The second agreement calls for Societal to conduct analytic method activities and development of a liquid oral formulation of an investigational treatment for pediatric patients with dietary restrictions suffering from neurological and neuropsychiatric diseases. Societal will also be responsible for the production and packaging of an initial engineering batch of the liquid oral formulation.

The scope of work under the third new contract includes clinical trial services to support Phase 2 clinical studies of a novel antisense oligonucleotide being developed for the treatment of various cancers. Activities will include labeling and storage of vials of the investigational compound, as well as vial distribution to clinical trial sites.

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.

FAQ

What are the key details of Societal CDMO's new contracts as of August 2022?

Societal CDMO announced three new contracts focusing on clinical trial services, formulation development, and cGMP manufacturing, involving a Phase 2 study for a melatonergic antidepressant and treatments for pediatric patients with dietary restrictions.

How will the new contracts impact Societal CDMO's growth?

The contracts are expected to drive growth by enhancing Societal CDMO's service offerings and expanding its client base, particularly in clinical trial services, which are seen as a key growth area.

What specific services will Societal CDMO provide under the new agreements?

Societal CDMO will provide clinical trial support, including sourcing study drugs, analytical method development, and the production of liquid formulations, as well as cGMP manufacturing and packaging.

What is the significance of the Phase 2 clinical studies mentioned in the press release?

The Phase 2 clinical studies signify an important step in the drug development process, testing the efficacy and safety of potential treatments for various conditions, indicating the company's involvement in significant therapeutic advancements.

What potential risks does Societal CDMO face with its new contracts?

Potential risks include challenges in meeting customer demands, fluctuating costs of raw materials, and ongoing uncertainties related to the COVID-19 pandemic which may impact supply chains and service demand.