Financial Performance - The company reported net losses of $14.5 million and $22.4 million for the three months ended March 31, 2022 and 2021, respectively, with an accumulated deficit of $417.2 million as of March 31, 2022[81]. - The net loss for Q1 2022 was $14.5 million, improving by 35% from a net loss of $22.4 million in Q1 2021[95]. - Cash used in operating activities was $12.1 million in Q1 2022, significantly lower than $24.4 million in Q1 2021[106]. - Total operating expenses fell to $15.5 million in Q1 2022, a decrease of 35% compared to $23.9 million in Q1 2021[95]. - Collaboration revenue was $0.8 million in Q1 2022, down 46% from $1.5 million in Q1 2021[96]. - Research and development expenses decreased to $9.7 million in Q1 2022 from $17.0 million in Q1 2021, a reduction of 43%[99]. - Cash provided by investing activities was $2.5 million in Q1 2022, down from $27.6 million in Q1 2021[108]. Financing Activities - The company raised net proceeds of approximately $510.1 million from various financing activities, including $84.3 million from license and collaboration agreements[80]. - The company plans to fund future losses through equity and/or debt financings, as well as potential asset sales and collaborations[104]. Product Development - The company has not generated any revenue from drug product sales and does not expect to do so until regulatory approval is obtained[83]. - The license agreement with Biogen, which included a $15.0 million upfront payment, is set to terminate in May 2022[82]. - CB 4332, an engineered albumin-fused Complement Factor I molecule, is designed for subcutaneous or intravitreal administration to address complement imbalance disorders[72]. - CB 2782-PEG, a potential best-in-class C3 degrader, aims to treat dry age-related macular degeneration and has shown potential in preclinical models[70]. - The company has discontinued the development of its protease programs and is focusing on monetizing its assets[62]. - MarzAA, a next-generation Factor VIIa variant, has been discontinued in its Phase 3 trial due to enrollment challenges and competition[77]. - DalcA, a next-generation Factor IX product candidate, has completed a Phase 2b study showing raised FIX plasma activity levels and is exploring licensing opportunities[79]. - The company has several early-stage complement discovery programs targeting various proteins of the complement system[76]. Strategic Outlook - The company expects minimal research and development expenses in the next year as it explores strategic opportunities[88]. - The company incurred $3.8 million in charges to write off prepaid manufacturing costs related to the MarzAA program[91].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-51173 Catalyst Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 56-2020050 (State or Other Jurisdiction of ...

Pipeline and Product Development - Catalyst Biosciences is focused on developing protease therapeutics targeting disorders of the complement system, with a pipeline including a preclinical C3 degrader program licensed to Biogen for geographic atrophy in dry AMD[77]. - The complement portfolio includes CB 4332, a first-in-class CFI molecule for subcutaneous administration in CFI deficiency, and CB 2782-PEG, a C3 degrader in preclinical development for dry AMD[79]. - Patient enrollment for the CFI-001 and CFI-002 studies commenced in July 2021 to assess CFI blood levels and identify candidates for CB 4332 treatment[80]. - The prevalence of rare CFI variants in the overall AMD population is estimated at approximately 6%, with around 40% expected to have low serum CFI levels that could benefit from targeted therapy[91]. - The ProTUNE™ C3b/C4b degrader platform is prioritizing IgA nephropathy, which affects over 100,000 individuals in the US and leads to significant economic burden due to chronic treatment costs[95]. - The ImmunoTUNE™ C3a/C5a degrader platform targets ANCA vasculitis, with an estimated addressable patient population of around 50,000 in the US[96]. - MarzAA, a next-generation Factor VIIa variant, has seen enrollment in a Phase 3 trial for hemophilia treatment but has been discontinued due to enrollment challenges and competition[97]. - The company is exploring opportunities to license or sell MarzAA for further development following the discontinuation of its trials[97]. - The protease candidates are designed to have improved properties such as longer half-life and higher potency, potentially allowing for better safety and efficacy in treatment[78]. - DalcA, a next-generation SQ Factor IX product candidate, completed a Phase 2b study in 2020, raising FIX plasma activity levels from severe to mild phenotype[98]. - The company is actively seeking a partner for the DalcA program and exploring opportunities for licensing or selling it for further development[98]. Financial Performance - In Q1 2021, the company issued 9,185,000 shares at $5.75 per share, netting approximately $49.3 million after underwriting discounts[101]. - The company reported net losses of $25.2 million for Q3 2021, compared to $16.0 million for Q3 2020, marking a 57% increase in losses[103]. - Total research and development expenses for the nine months ended September 30, 2021, were $52.8 million, with significant investments in hemophilia and complement programs[113]. - License and collaboration revenue for Q3 2021 was $2.3 million, a 157% increase from $893,000 in Q3 2020[123]. - The accumulated deficit as of September 30, 2021, was $382.4 million, with cash and cash equivalents totaling $64.5 million[103]. - The company expects to incur significant expenses and increasing operating losses for the next several years as it continues development and seeks regulatory approval[104]. - Research and development expenses for hemophilia were $6.0 million for Q3 2021, and $17.8 million for the nine months ended September 30, 2021[113]. - The company has not generated any revenue from drug product sales and does not expect to until regulatory approval is obtained[109]. - License and collaboration revenue decreased to $4.9 million for the nine months ended September 30, 2021, down 74% from $18.9 million in the same period of 2020[125]. - Research and development expenses increased to $52.8 million for the nine months ended September 30, 2021, a rise of 37% compared to $38.4 million in 2020[128]. - General and administrative expenses rose to $14.8 million for the nine months ended September 30, 2021, reflecting a 24% increase from $11.9 million in 2020[130]. - The net loss for the nine months ended September 30, 2021, was $67.6 million, an increase of 81% from a net loss of $37.3 million in 2020[134]. - Cash used in operating activities for the nine months ended September 30, 2021, was $66.1 million, compared to $32.9 million in the same period of 2020[139]. - Cash provided by investing activities was $45.3 million for the nine months ended September 30, 2021, primarily due to $46.2 million in proceeds from maturities of investments[141]. - Cash provided by financing activities was $49.6 million for the nine months ended September 30, 2021, mainly from $49.3 million in net proceeds from the issuance of common stock[142]. - As of September 30, 2021, the company had $64.5 million in cash, cash equivalents, and short-term investments[134]. - The accumulated deficit as of September 30, 2021, was $382.4 million[134]. - The company plans to fund future losses through equity and/or debt financings, as well as potential asset sales and collaborations[135]. Operational Challenges - Catalyst continues to face operational challenges due to the COVID-19 pandemic, which may impact development timelines[82].

Part I [Business](index=5&type=section&id=Item%201.%20Business) Catalyst Biosciences develops engineered proteases for complement and coagulation disorders, with lead candidate MarzAA entering a Phase 3 trial - The company focuses on engineering proteases for complement and coagulation disorders, with its lead candidate **MarzAA** (a next-gen FVIIa) entering a **registrational Phase 3 trial** for hemophilia with inhibitors[15](index=15&type=chunk)[17](index=17&type=chunk) - The complement pipeline includes **CB 4332** for CFI deficiency and **CB 2782-PEG** for dry AMD, the latter being developed in collaboration with **Biogen**[18](index=18&type=chunk) - The company's next most advanced hemophilia candidate is **DalcA**, a next-generation SQ FIX for Hemophilia B, which has completed a **Phase 2b trial**[19](index=19&type=chunk) [Product Pipeline and Development Programs](index=5&type=section&id=Item%201.%20Business%23Product%20Pipeline) The company's pipeline focuses on hemostasis and complement disorders, with lead candidate MarzAA advancing to Phase 3 and DalcA completing Phase 2b - **MarzAA** is entering a **registrational Phase 3 trial (MAA-304)** for on-demand treatment of bleeding in hemophilia patients with inhibitors, with a Phase 1/2 trial (MAA-202) also planned for other rare bleeding disorders[17](index=17&type=chunk)[39](index=39&type=chunk)[41](index=41&type=chunk) - The FDA granted **Fast Track designation** for MarzAA for treating episodic bleeding in patients with Hemophilia A or B with inhibitors, validating its potential to address an unmet medical need[38](index=38&type=chunk) - The complement program **CB 2782-PEG** for dry AMD is licensed to **Biogen**, with Catalyst receiving a **$15.0 million upfront payment** and eligible for up to **$340.0 million in milestones** plus royalties[24](index=24&type=chunk)[25](index=25&type=chunk)[56](index=56&type=chunk) - The Factor IX gene therapy candidate, **CB 2679d-GT**, has shown **superior activity** in preclinical models compared to the Padua variant, potentially allowing for lower vector doses[65](index=65&type=chunk)[66](index=66&type=chunk) [Collaborations](index=15&type=section&id=Item%201.%20Business%23Collaborations) Catalyst has key collaborations including a legacy agreement with Pfizer for MarzAA, a partnership with ISU Abxis for DalcA, and a major deal with Biogen for CB 2782-PEG - Collaboration with **Biogen** for **CB 2782-PEG**: Catalyst received a **$15.0 million upfront payment** and is eligible for up to **$340.0 million in milestones** and tiered royalties[72](index=72&type=chunk) - Agreement with **Pfizer** for **MarzAA**: Catalyst owes up to **$17.5 million in milestone payments** and single-digit royalties on net sales, with a **$1.0 million milestone** paid in February 2018[69](index=69&type=chunk) - Partnership with **ISU Abxis** for **DalcA**: ISU holds commercial rights in South Korea, and Catalyst owes up to **$19.5 million in milestones** and low single-digit royalties on sales in other regions[71](index=71&type=chunk) [Competition](index=16&type=section&id=Item%201.%20Business%23Competition) The company faces significant competition from larger pharmaceutical companies across its Factor VIIa, Factor IX, and dry AMD programs - Factor VIIa competition for **MarzAA** includes approved products like **Novo Nordisk's NovoSeven RT**, **Takeda's FEIBA**, **Roche's Hemlibra**, and HEMA Biologics' SEVENFACT[77](index=77&type=chunk)[78](index=78&type=chunk) - Factor IX competition for **DalcA** includes **Pfizer's BeneFIX**, Sanofi/SOBI's Alprolix, and **CSL Behring's Idelvion**, with several companies also developing Factor IX gene therapies[78](index=78&type=chunk) - While no treatments are approved for dry AMD, several companies are in clinical studies, including **Apellis (APL-2)**, **Iveric Bio (Zimura®)**, and **Gemini Therapeutics (GEM103)**[78](index=78&type=chunk) [Intellectual Property](index=18&type=section&id=Item%201.%20Business%23Intellectual%20Property) As of year-end 2020, the company's patent portfolio included 72 issued patents and 12 pending applications, covering its lead candidates and novel proteases - As of year-end 2020, the patent portfolio included approximately **72 issued patents** and **12 pending applications**[82](index=82&type=chunk) - Patents covering **MarzAA** (modified Factor VII) expire in **2029-2031** in the U.S. and patents covering **DalcA** (modified Factor IX) expire between **2030-2038**[91](index=91&type=chunk) - A recently issued patent covering the portfolio of engineered C3-degrading proteases, including lead candidate **CB 2782-PEG**, provides protection until at least **2038**[60](index=60&type=chunk) [Manufacturing and Commercialization](index=20&type=section&id=Item%201.%20Business%23Manufacturing%20and%20Commercialization) Catalyst relies on third-party contract manufacturers for drug substance and product, and plans to retain U.S. commercial rights for hemophilia candidates - The company relies on **third parties for manufacturing** and does not own any facilities, with key partners including **AGC Biologics** for drug substance and **Catalent** and **Symbiosis** for drug product[95](index=95&type=chunk)[96](index=96&type=chunk)[99](index=99&type=chunk) - **Two large-scale GMP batches of MarzAA** have been successfully completed at AGC, sufficient to support the Phase 3 clinical trial (MAA-304)[96](index=96&type=chunk) - The company plans to retain U.S. commercial rights for its hemophilia products and may build a specialized sales force, but has not yet developed a commercial strategy outside the U.S[101](index=101&type=chunk) [Government Regulation](index=21&type=section&id=Item%201.%20Business%23Government%20Regulation) The company's biologic products are subject to extensive FDA regulation, including IND/BLA processes, and ongoing compliance with healthcare laws - The company's products are regulated as **biologics**, requiring an extensive process of preclinical and clinical testing before a **Biologics License Application (BLA)** can be submitted to the FDA for approval[102](index=102&type=chunk)[105](index=105&type=chunk) - **MarzAA** has received **Orphan Drug designation** in the U.S. and E.U. and **Fast Track designation** from the FDA, while **DalcA** has received Orphan Drug designation in both the U.S. and E.U[123](index=123&type=chunk)[128](index=128&type=chunk) - The company is subject to numerous other laws, including the federal **Anti-Kickback Statute**, **HIPAA**, and the **Physician Payments Sunshine Act**, which regulate marketing, data privacy, and financial relationships with healthcare providers[139](index=139&type=chunk)[140](index=140&type=chunk)[147](index=147&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including COVID-19 impacts, substantial accumulated losses requiring additional capital, reliance on third parties, and intellectual property challenges - The **COVID-19 pandemic** has caused operational challenges, including delays in clinical trial enrollment for MAA-304 and MAA-202, and poses a risk to manufacturing and supply chains[173](index=173&type=chunk)[175](index=175&type=chunk) - The company has incurred **significant losses since inception ($314.8 million accumulated deficit** as of Dec 31, 2020) and expects to continue incurring losses, requiring substantial additional capital to fund development programs[174](index=174&type=chunk)[191](index=191&type=chunk)[201](index=201&type=chunk) - **Reliance on third parties** is a key risk, including the success of the Biogen collaboration, the performance of contract manufacturers, and the potential for government requisition of manufacturing capacity for COVID-19 vaccines[174](index=174&type=chunk)[188](index=188&type=chunk)[222](index=222&type=chunk) - There is a risk of **intellectual property infringement claims**, with a patent family that may read on MarzAA pending, though the company believes the claims are not patentable[257](index=257&type=chunk) [Properties](index=63&type=section&id=Item%202.%20Properties) The company leases approximately 16,208 square feet for its corporate headquarters in South San Francisco, with the current lease expiring in April 2023 - The company leases approximately **16,208 square feet** for its corporate headquarters in South San Francisco, California[325](index=325&type=chunk) - The current lease term expires on **April 30, 2023**[325](index=325&type=chunk) [Legal Proceedings](index=63&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business or financial condition - The company is not presently a party to any **material legal proceedings**[327](index=327&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=64&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Catalyst Biosciences' common stock trades on Nasdaq under 'CBIO', with no cash dividends ever paid or anticipated, as earnings are retained for development - The company's common stock trades on the **Nasdaq Capital Market** under the ticker symbol **'CBIO'**[331](index=331&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future, retaining funds for development[333](index=333&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=65&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For 2020, Catalyst reported $20.9 million in revenue, a net loss of $56.2 million, and ended the year with $81.9 million in cash, sufficient for the next 12 months - In 2020, the company raised approximately **$60.0 million in net proceeds** from two underwritten public offerings of common stock in February and June[373](index=373&type=chunk)[374](index=374&type=chunk)[411](index=411&type=chunk) - The company believes its existing capital of **$81.9 million** (as of Dec 31, 2020) is sufficient to fund operations for at least the **next 12 months**[402](index=402&type=chunk)[403](index=403&type=chunk) [Results of Operations](index=72&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations%23Results%20of%20Operations) In 2020, the company generated $20.9 million in revenue, with R&D and G&A expenses increasing 21%, resulting in a net loss of $56.2 million Results of Operations (in thousands) | | 2020 | 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **License and collaboration revenue** | **$20,948** | **$—** | **$20,948** | **N/A** | | *License* | $15,100 | $— | $15,100 | N/A | | *Collaboration* | $5,848 | $— | $5,848 | N/A | | **Total operating expenses** | **$78,318** | **$57,277** | **$21,041** | **37%** | | *Cost of license and collaboration* | $9,163 | $— | $9,163 | N/A | | *Research and development* | $52,975 | $43,859 | $9,116 | 21% | | *General and administrative* | $16,180 | $13,418 | $2,762 | 21% | | **Loss from operations** | **($57,370)** | **($57,277)** | **($93)** | **0%** | | **Net loss** | **($56,241)** | **($55,178)** | **($1,063)** | **2%** | - R&D expenses increased by **$9.1 million (21%)** in 2020, primarily due to a **$7.0 million increase** in preclinical research and a **$2.3 million increase** in personnel costs[398](index=398&type=chunk) - G&A expenses increased by **$2.8 million (21%)** in 2020, mainly driven by a **$2.8 million increase** in professional services[399](index=399&type=chunk) [Liquidity and Capital Resources](index=73&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations%23Liquidity%20and%20Capital%20Resources) As of December 31, 2020, Catalyst had $81.9 million in cash, bolstered by $60.4 million from public offerings, deemed sufficient for at least 12 months Cash Flow Summary (in thousands) | | Year Ended Dec 31, 2020 | Year Ended Dec 31, 2019 | | :--- | :--- | :--- | | Cash used in operating activities | $(55,048) | $(43,613) | | Cash provided by investing activities | $9,663 | $27,392 | | Cash provided by financing activities | $60,376 | $327 | | **Net increase (decrease) in cash** | **$14,991** | **$(15,894)** | - As of December 31, 2020, the company had cash, cash equivalents, and investments of **$81.9 million** and an accumulated deficit of **$314.8 million**[402](index=402&type=chunk) - In Q1 2021, the company raised approximately **$49.3 million in net proceeds** from the sale of common stock[405](index=405&type=chunk)[560](index=560&type=chunk) [Financial Statements and Supplementary Data](index=78&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The audited financial statements for 2020 show total assets of $94.8 million and a net loss of $56.2 million, with R&D expense estimation noted as a critical audit matter Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $30,360 | $15,369 | | Total current assets | $89,510 | $96,066 | | **Total assets** | **$94,846** | **$98,554** | | Total current liabilities | $17,796 | $28,899 | | **Total liabilities** | **$18,777** | **$30,218** | | **Total stockholders' equity** | **$76,069** | **$68,336** | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2020 | Year Ended Dec 31, 2019 | | :--- | :--- | :--- | | License and collaboration revenue | $20,948 | $— | | Total operating expenses | $78,318 | $57,277 | | Loss from operations | $(57,370) | $(57,277) | | **Net loss** | **$(56,241)** | **$(55,178)** | | **Net loss per share** | **$(2.93)** | **$(4.60)** | - The independent auditor, EisnerAmper LLP, identified the estimation of research and development expenses as a **critical audit matter** due to the significant judgment required by management[437](index=437&type=chunk)[439](index=439&type=chunk)[441](index=441&type=chunk) [Controls and Procedures](index=103&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2020 - Management concluded that the company's **disclosure controls and procedures** were effective as of December 31, 2020[563](index=563&type=chunk) - Based on the **COSO 2013 framework**, management assessed internal control over financial reporting to be effective as of December 31, 2020[565](index=565&type=chunk) Part III [Directors, Executive Officers, Corporate Governance, Compensation, and Security Ownership](index=105&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%2014) Information for directors, executive officers, corporate governance, compensation, and security ownership is incorporated by reference from the forthcoming Proxy Statement - Information regarding Directors, Executive Officers, Corporate Governance (Item 10), Executive Compensation (Item 11), Security Ownership (Item 12), Certain Relationships and Related Transactions (Item 13), and Principal Accountant Fees (Item 14) is **incorporated by reference** from the company's forthcoming Proxy Statement[569](index=569&type=chunk)[570](index=570&type=chunk)[571](index=571&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=106&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the 10-K, including material contracts and certifications from the CEO and CFO - This section contains the list of all exhibits filed with the 10-K, including material contracts like the **License and Collaboration Agreement with Biogen** and the **Amended and Restated License Agreement with ISU Abxis**[578](index=578&type=chunk)[581](index=581&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer pursuant to **Sarbanes-Oxley Sections 302 and 906** are included as exhibits[583](index=583&type=chunk)

Form 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact Name of Registrant as Specified in its Charter) Delaware 56-2020050 (State or Other Jurisdiction of Incorporation or Organization) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission fi ...

Clinical Trials and Drug Development - Catalyst Biosciences is initiating a Phase 3 clinical trial for MarzAA, targeting approximately 230 bleeding episodes in about 75 patients with Hemophilia A or B with inhibitors[73]. - The Phase 2b study for DalcA showed effective prophylaxis with FIX activity levels ranging from 14% to 28% and zero bleeds, with a half-life of 70 to 112 hours[79]. - MarzAA has demonstrated the potential for a safety profile comparable to NovoSeven when used in combination with Hemlibra, providing a subcutaneous rescue therapy option[77]. - The company completed two large-scale GMP batches of MarzAA sufficient to support the Phase 3 clinical trial[86]. - Catalyst is optimizing its Factor IX gene therapy construct CB 2679d-GT, which has shown 2-fold to 3-fold higher activity compared to the Padua variant in preclinical studies[80]. - The company is experiencing operational challenges due to the COVID-19 pandemic, which may impact clinical trial timelines and patient enrollment[90]. Financial Performance - The company reported a net loss of $4.1 million for the three months ended March 31, 2020, compared to a net loss of $15.1 million for the same period in 2019, representing a 73% decrease in net loss[93][111]. - As of March 31, 2020, the company had an accumulated deficit of $262.6 million and cash, cash equivalents, and short-term investments totaling $104.5 million[93][118]. - License and collaboration revenue for the three months ended March 31, 2020, was $16.4 million, all derived from the Biogen Agreement[95][112]. - Total operating expenses increased by 36% to $21.4 million for the three months ended March 31, 2020, compared to $15.7 million in the same period of 2019[111]. - Research and development expenses rose to $13.3 million for the three months ended March 31, 2020, up from $12.0 million in 2019, marking a 10% increase[100][114]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years as it continues development and seeks regulatory approval for its drug candidates[94]. Cash Flow and Financing - Cash used in operating activities was $4.8 million for the three months ended March 31, 2020, compared to $14.96 million in the same period of 2019[120]. - The company has committed to a total of $10.7 million in payments to AGC for manufacturing development activities, with $3.4 million outstanding as of March 31, 2020[104]. - Interest and other income increased to $1.0 million for the three months ended March 31, 2020, compared to $0.6 million in 2019, primarily due to a $0.7 million payment from a prior asset sale[116]. - The company plans to fund future losses through equity and/or debt financings, with effective registration statements allowing for the sale of up to $200.0 million in securities[119]. - Cash provided by investing activities for Q1 2020 was $27.4 million, mainly from $33.5 million in proceeds from maturities of investments[123]. - Cash provided by financing activities for Q1 2020 was $32.4 million, due to $32.0 million in net proceeds from the issuance of common stock[125]. - Cash provided by financing activities for Q1 2019 was $0.1 million, entirely from the issuance of common stock related to the Employee Stock Purchase Plan[126]. - As of March 31, 2020, the company had cash and cash equivalents and short-term investments totaling $104.5 million[130]. Market Risks and Accounting Policies - The company does not have any off-balance sheet arrangements[127]. - The company is exposed to market risks, particularly interest income sensitivity in its investment portfolio[129]. - Future investment income may fall short of expectations due to changes in interest rates[129]. - The short-term nature of the instruments in the portfolio minimizes the impact of sudden changes in market interest rates[130]. - There have been no significant changes to critical accounting policies since December 31, 2019[128].

Financial Performance - The company reported a net loss of $55.2 million for the year ended December 31, 2019, compared to a net loss of $30.1 million for the year ended December 31, 2018, resulting in an accumulated deficit of $258.5 million as of December 31, 2019[297]. - Net loss for 2019 was $55.2 million, compared to a net loss of $30.1 million in 2018, representing an increase of 84%[318]. - Cash used in operating activities was $43.6 million in 2019, up from $28.6 million in 2018, reflecting a significant increase in net loss[321]. - Interest and other income decreased by 44% to $2.1 million in 2019 from $3.8 million in 2018, primarily due to the absence of significant milestone payments[315]. Research and Development - Research and development expenses for the year ended December 31, 2019, totaled $43.9 million, significantly increasing from $21.5 million in 2018, with clinical manufacturing costs rising from $12.2 million to $26.1 million[301]. - Research and development expenses increased by 104% to $43.9 million in 2019 from $21.5 million in 2018, primarily due to increased manufacturing activities and personnel-related expenses[312]. - The company expects research and development expenses to increase materially in 2020 due to costs associated with clinical trials and manufacturing[313]. - The company completed a Phase 1/2 SQ dosing trial for DalcA, achieving protective Factor IX activity levels of 12-30% with no reported serious adverse events[288]. - MarzAA, the company's most advanced product candidate, is currently in a SQ Phase 1 study to evaluate its pharmacokinetics and pharmacodynamics, with interim data indicating target levels consistent with treating a bleed[286]. Collaborations and Funding - The company entered into a collaboration agreement with Biogen, receiving a $15 million upfront payment and being eligible for up to $340 million in milestone payments for the development of anti-C3 proteases[290]. - The company raised approximately $32 million from the sale of 5,307,692 shares of common stock at $6.50 per share in February 2020[295]. - The company plans to fund future losses and capital needs through equity and/or debt financings, with effective registration statements allowing for the sale of up to $200.0 million in securities[319]. Cash and Investments - As of December 31, 2019, the company had cash, cash equivalents, and short-term investments totaling $76.9 million[297]. - Cash provided by investing activities was $27.4 million in 2019, primarily due to $157.4 million in proceeds from maturities of investments[324]. - As of December 31, 2019, the company had $76.9 million in cash, cash equivalents, and short-term investments, with an accumulated deficit of $258.5 million[318]. Operating Expenses - General and administrative expenses rose by 9% to $13.4 million in 2019 from $12.4 million in 2018, driven by higher personnel-related costs[314]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years as it continues clinical development and seeks regulatory approval for its drug candidates[298]. Manufacturing and Agreements - The company has a long-term development and manufacturing services agreement with AGC Biologics for drug substance manufacturing, successfully completing a GMP batch of MarzAA to support future studies[292]. - The company has firm work orders totaling $12.4 million with AGC for the manufacture of MarzAA and DalcA to support clinical trials, with $4.6 million still outstanding[304]. - Contract revenue decreased to $0.0 million in 2019 from $0.01 million in 2018, a decline of 100% due to the end of a collaboration agreement[311]. Lease Accounting - The company adopted the new lease accounting standard ASC 842 on January 1, 2019, using the optional transition method, which does not restate comparative financial information[344]. - Operating lease liabilities and corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term[345]. - The company utilizes its incremental borrowing rate for lease contracts, as the interest rate implicit in lease contracts is typically not readily determinable[345]. - Lease and non-lease components are combined as a single component, with lease expense recognized over the expected term on a straight-line basis[346]. - Operating leases are recognized on the balance sheet as right-of-use assets and operating lease liabilities, eliminating the recognition of deferred rent[346].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-51173 Catalyst Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 56-2020050 (State or Other ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Catalyst Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 56-2020050 (State or Other Jurisdiction of Incorporation or Organization) 611 Gateway Blvd., Suite 710 South San Francisco, California 94080 (Address of Principal Executive Offices) (Zip Code) (I.R.S. Employer Identification No.) For the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-51173 Catalyst Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Washington, D.C. 20549 Form 10-Q Indicate by check mark whether the regi ...