Marzeptacog alfa (activated) – MarzAA: The U.S. Food and Drug Administration (FDA) granted Fast Track Designation for Marzeptacog alfa (activated) – or MarzAA, the Company’s subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with hemophilia A or B with inhibitors. The Company also presented a poster at the Annual American Society of Hematology (ASH) meeting in December 2020. Linda Neuman, MD, vice president of clinical development, presented the rationale and design of the Crimson 1 (MAA-304) Phase 3 study.

Systemic Complement Regulator Program: In December 2020, the Catalyst team hosted a research and development meeting on the Company’s first subcutaneously dosed systemic complement development candidate, CB 4332, an extended half-life CFI, and a C4b degrader program that targets classical complement disorders. Catalyst is leveraging its proprietary protease engineering platform expertise to develop several proteases that regulate the complement cascade that can be applied to treat many diseases.

Completed a $52.8 million financing: Catalyst raised approximately $52.8 million in gross proceeds during the first quarter of 2021, before deducting underwriting discounts and commissions and other estimated offering expenses, in a total offering of 9,185,000 shares of its common stock. Net proceeds from the offering were approximately $49.3 million. Cash, cash equivalents and investments, as of December 31, 2020 were $81.9 million.

MarzAA:

Initiate and enroll the Crimson 1 Phase 3 open-label trial evaluating the efficacy of SQ MarzAA to treat episodic bleeding in individuals with hemophilia A or B with inhibitors;

Initiate and enroll a Phase 1/2 trial (MAA 202) in FVII Deficiency, Glanzmann Thrombasthenia, and Hemlibra^® patients;

Submit the first Crimson 1 report to the Data and Safety Monitoring Board (DSMB).

Systemic Complement Program:

Commence enrollment of an observational trial in mid-2021 assessing CFI activity and genotype in patients who have diseases associated with CFI deficiency to identify those who would benefit from CB 4332 treatment.

Cash, cash equivalents and investments, as of December 31, 2020 were $81.9 million. During the first quarter of 2021, the Company completed equity financing raising approximately $49.3 million in net proceeds.

Research and development expense for the three-months and year-ended December 31, 2020 was $14.6 million and $53.0 million, respectively, compared with $10.8 million and $43.9 million for the prior year periods, respectively. The increase was due primarily to an increase in personnel-related costs, pre-clinical research and facilities costs, partially offset by a decrease in clinical manufacturing costs.

General and administrative expense for the three-months and year-ended December 31, 2020 was $4.3 million and $16.2 million, respectively, compared with $3.2 million and $13.4 million for the prior year periods, respectively. The increase was due primarily to an increase in professional services and personnel-related costs.

Interest and other income, net, for the three-months and year-ended December 31, 2020 was ($0.1) million and $1.1 million, respectively, compared with $0.4 million and $2.1 million for the prior year periods, respectively.

In connection with its Biogen Agreement, the Company received a $15.0 million upfront license fee on January 10, 2020 and made a $3.0 million payment to Mosaic Biosciences that was recorded as the cost of the license. The Company also recognized reimbursable out-of-pocket third-party expenses of $2.0 million and $6.1 million for the three-months and year-ended December 31, 2020, respectively, which were recorded as costs of collaboration revenue.

Net loss attributable to common stockholders for the three-months and year-ended December 31, 2020 was $18.9 million, or ($0.86) per basic and diluted share, and $56.2 million, or ($2.93) per basic and diluted share, respectively, compared with $13.6 million, or ($1.23) per basic and diluted share, and $55.2 million, or ($4.60) per basic and diluted share, for the prior year periods, respectively.

As of December 31, 2020, the Company had 22,097,820 shares of common stock outstanding.

Assets

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Commitments and Contingencies (Note 7)

Stockholders’ equity:

Preferred stock, $0.001 par value, 5,000,000 shares authorized; zero

shares issued and outstanding

Common stock, $0.001 par value, 100,000,000 shares authorized;

22,097,820 and 12,040,835 shares issued and outstanding at

December 31, 2020 and 2019, respectively

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Cost of collaboration

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Shares used to compute net loss per share attributable to common stockholders, basic and diluted