RARE Daily

Passage Bio, Codexis Streamline Operations and Cut Staff

July 21, 2023

Rare Daily Staff

Passage Bio and Codexis, two companies developing therapeutics for rare diseases, said they are streamlining operations and cutting staff to continue development of lead programs.

In an SEC filing, Passage Bio, a gene therapy biotech focused on CNS disorders with ties to James Wilson and the Gene Therapy program at the University of Pennsylvania, said it is embarking on an “organizational redesign” intended to better align its resources and further extend its cash runway. The redesign includes a workforce reduction by approximately 26 percent, primarily in Passage Bio’s CMC group. This follows a 13 percent staff reduction announced in May. As part of the reduction Simona King, the company’s chief financial officer, and Alex Fotopoulos, the company’s chief technical officer, are leaving effective on or about July 28, 2023.

As a result of the reorganization, Passage Bio now expects that its existing cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025, beyond multiple expected milestones for its ongoing clinical programs, including PBGM01 for GM1 gangliosidosis and PBFT02 for frontotemporal dementia. Both are expected to report interim data this year.

Meanwhile, Codexis said it intends to prioritize the advancement and commercialization of its Enzyme-Catalyzed Oligonucleotide (ECO) Synthesis platform and its highly complementary pharmaceutical manufacturing business. As part of this enhanced strategic focus, the company is streamlining operations, including discontinuing investment in certain development programs, primarily in its preclinical biotherapeutics pipeline, consolidating operations to its headquarters and reducing headcount by approximately 25 percent. With these changes, Codexis expects it will be able to fund its planned operations to mid-2026, providing the opportunity to deliver on critical milestones related to its ECO Synthesis platform.

“As a result of our disciplined portfolio streamlining, Codexis now reflects a built-to-win, focused organization with cash runway to fuel our strategic priorities through mid-2026, including the commercialization of our ECO Synthesis platform,” said Stephen Dilly, president and CEO of Codexis. “By building upon our existing strength in enzyme engineering, we believe we have identified a concentrated group of potential high-impact programs where our enzymes and expertise can drive meaningful differences for life science and pharmaceutical customers.”

With more than 450 RNAi therapies currently in clinical development, including more than 40 assets in phase 2 and phase 3 clinical trials targeting disease indications impacting millions of patients, demand for siRNA is projected to outpace current production capabilities in the coming years. By enabling the manufacture of these therapeutics through an enzymatic route, Codexis’ ECO Synthesis technology is specifically engineered to address the challenges with scalability and sustainability associated with traditional phosphoramidite chemistry methods. Codexis anticipates demonstrating gram-scale synthesis of the platform by the end of 2023, providing a key point of technical validation to enable select pre-commercial customer testing of the platform to begin in 2024.

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