| Item 2.02 | Results of Operations and Financial Condition. |
On November 12, 2021, Catalyst Biosciences, Inc., (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2021. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information set forth in this Item 2.02 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.
| Item 2.05 | Costs Associated with Exit or Disposal Activities. |
On November 12, 2021, the Company announced its strategic decision to stop the clinical development of MarzAA (engineered FVIIa), focus solely on its complement programs and protease medicines platform, and sell or license the Company’s hemophilia portfolio (the “Restructuring”). In connection with these actions, the Company will reduce headcount by approximately 27 full-time equivalent personnel, or approximately 35% and expects to reduce its annual expenditures by approximately 40%. This decision, approved by the Company’s Board of Directors, follows a recently updated feasibility assessment where the Company determined that it was not in the best interests of its stockholders to continue to finance MarzAA through the completion of the ongoing trials based on anticipated timelines and expense, along with a review of the opportunities presented by the Company’s protease platform for complement-mediated diseases.
As a result of the Restructuring, the Company estimates that it will incur up to $0.6 million in costs related to one-time severance costs and related expenses, of which approximately $0.4 million will be incurred in the fourth quarter of 2021 and $0.2 million in the first quarter of 2022. The reduction in force is expected to be substantially completed by the end of the first quarter of 2022. The estimates of costs that the Company expects to incur and the timing thereof are subject to a number of assumptions and actual results may differ. The Company may also incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the decision to stop clinical development of MarzAA.
A copy of the press release announcing the Restructuring is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference to this item.
Forward-Looking Statements
This item 2.05 contains forward-looking statements that are intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward looking statements are statements that are not historical facts. Words such as “expects,” “believes,” “will,” “may,” “anticipates” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the anticipated benefits of the Restructuring, the anticipated timing and details of the reduction in workforce and expected charges and costs associated with the reduction in workforce that the Company expects to incur. These statements are based on current expectations, estimates and projections about the Company’s business based, in part, on assumptions made by management, and are subject to a number of risks and uncertainties. Factors that could cause actual results to differ materially from current expectations include possible changes in the expected costs and charges associated with the reduction in force, and risks associated with the Company’s ability to achieve the expected benefits of the reduction in force and realignment of its resources. Additionally, these forward-looking statements should be considered in conjunction with the cautionary statements and risk factors described in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, and its other filings filed from time to time with the Securities and Exchange Commission. The Company does not assume any obligation to update any forward-looking statement, except as required by law.
