Full Press Release Details
Catalyst Biosciences Reports Second Quarter 2021 Operating & Financial Results and Provides a
SOUTH SAN FRANCISCO, Calif. August 5, 2021 Catalyst Biosciences, Inc. (NASDAQ: CBIO) today
announced its operating and financial results for the second quarter ended June 30, 2021, and provided a corporate update.
progress in our complement and hemostasis programs. In complement, we are advancing the development of our SQ enhanced CFI development candidate, CB 4332, where we screened the first patient in our natural history study for CFI deficiency
( ConFIrm ). We also recently disclosed new proteases from our ProTUNE ; C3b-C4b degrader and ImmunoTUNE ; C3a-C5a degrader platforms designed to target specific disorders of the complement or inflammatory pathways, said Nassim Usman, Ph.D., president
and chief executive officer of Catalyst. With the initiation of the ConFIrm study and our plans to enter the clinic with CB 4332 in 2022 on track, we are building a robust pipeline in complement. We also continue to make progress in our
Crimson 1 Phase 3 registrational study of MarzAA, in hemophilia A or B with inhibitors as well as in our Phase 1/2 trial in other rare bleeding disorders.
Systemic Complement Program
Second Quarter 2021 Results and Financial Highlights
About Catalyst Biosciences, the Protease Medicines company
Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and
coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic
bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a preclinical C3-degrader program licensed to Biogen for dry age-related macular
degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and proteases from our ProTUNE
C3b-C4b degrader and ImmunoTUNE C3a-C5a degrader platforms designed to target specific disorders of the
complement or inflammatory pathways as well as other complement programs in development.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include, without
limitation, statements about the product candidates of Catalyst Biosciences, Inc. (the Company ) and the benefits of its protease engineering platform; plans to complete the ConFIrm and ConFIdence studies and the expectation that the
studies will inform opportunities to develop CB 4332; plans to submit an IND for CB 4332; plans to announce development candidates in lead discovery programs and present PK and biomarker data for CB 4332; plans to continue enrollment of the Phase 3
and Phase 1/2 trials of MarzAA; the potential markets for and advantages of the Company s complement product candidates, including CB 2782-PEG, CB 4332 and complement degraders; plans for the
Company s collaboration with Biogen; and plans to start a clinical trial of CB 4332 in 2022.
Actual results or events could differ materially from
the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially, including, but not limited to, the risk that trials and studies may
be delayed as a result of COVID-19, competitive products and other factors, that trials may not have satisfactory outcomes, the risk that the ConFIrm and ConFIdence trials will not validate the potential
market for CB 4332; the risk Catalyst may elect to terminate or postpone ongoing development programs, including development of MarzAA or any of the Company s complement assets; the risk that the Company will need to raise additional capital,
which may not be available on faorable terms if at all; the risk that Biogen will terminate Catalyst s agreement, and other risks described in the Risk Factors section of the Company s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 6, 2021, and in other filings with the Securities and Exchange Commission. The Company does not assume any obligation to update any
forward-looking statements, except as required by law.
Catalyst Biosciences, Inc.
Catalyst Biosciences, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| June 30, 2021 | December 31, 2020 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 73,621 | $ | 30,360 | ||||
| Short-term investments | 12,902 | 48,994 | ||||||
| Accounts receivable | 1,971 | 3,313 | ||||||
| Prepaid and other current assets | 8,332 | 6,843 | ||||||
| Total current assets | 96,826 | 89,510 | ||||||
| Long-term investments | 2,543 | |||||||
| Other assets, noncurrent | 1,169 | 528 | ||||||
| Right-of-use assets | 3,107 | 1,832 | ||||||
| Property and equipment, net | 684 | 433 | ||||||
| Total assets | $ | 101,786 | $ | 94,846 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,834 | $ | 5,931 | ||||
| Accrued compensation | 2,516 | 2,476 | ||||||
| Deferred revenue | 2,038 | 1,983 | ||||||
| Other accrued liabilities | 7,366 | 6,743 | ||||||
| Operating lease liability | 1,814 | 663 | ||||||
| Total current liabilities | 15,568 | 17,796 | ||||||
| Operating lease liability, noncurrent | 1,054 | 981 | ||||||
| Total liabilities | 16,622 | 18,777 | ||||||
| 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; 31,349,740 and 22,097,820 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 31 | 22 | ||||||
| Additional paid-in capital | 442,258 | 390,803 | ||||||
| Accumulated other comprehensive income | 2 | 5 | ||||||
| Accumulated deficit | (357,127 | ) | (314,761 | ) | ||||
| Total stockholders equity | 85,164 | 76,069 | ||||||
| Total liabilities and stockholders equity | $ | 101,786 | $ | 94,846 |
Catalyst Biosciences, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| License | $ | $ | 23 | $ | $ | 15,068 | ||||||||||
| Collaboration | 1,132 | 1,635 | 2,599 | 2,956 | ||||||||||||
| License and collaboration revenue | 1,132 | 1,658 | 2,599 | 18,024 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of license | 23 | 3,070 | ||||||||||||||
| Cost of collaboration | 1,139 | 1,719 | 2,619 | 3,151 | ||||||||||||
| Research and development | 15,389 | 12,906 | 32,402 | 26,170 | ||||||||||||
| General and administrative | 4,518 | 4,371 | 9,930 | 8,062 | ||||||||||||
| Total operating expenses | 21,046 | 19,019 | 44,951 | 40,453 | ||||||||||||
| Loss from operations | (19,914 | ) | (17,361 | ) | (42,352 | ) | (22,429 | ) | ||||||||
| Interest and other income (expense), net | (14 | ) | 113 | (14 | ) | 1,128 | ||||||||||
| Net loss | $ | (19,928 | ) | $ | (17,248 | ) | $ | (42,366 | ) | $ | (21,301 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.64 | ) | $ | (0.96 | ) | $ | (1.42 | ) | $ | (1.31 | ) | ||||
| Shares used to compute net loss per share attributable to common stockholders, basic and diluted | 31,348,602 | 17,891,475 | 29,875,202 | 16,241,963 |