Full Press Release Details
Catalyst Biosciences Reports First Quarter 2021 Operating & Financial Results and Provides a
SOUTH SAN FRANCISCO, Calif. May 6, 2021 Catalyst Biosciences, Inc. (NASDAQ: CBIO) today
announced its operating and financial results for the first quarter ended March 31, 2021 and provided a corporate update.
progress across our Protease Medicines platform, specifically in our complement and hemostasis programs. We are preparing to initiate an observational trial in patients who have diseases related to CFI deficiency in
mid-year 2021 to support our SQ enhanced CFI development candidate CB 4332 that will enter the clinic in 2022, said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. In
hemostasis, we dosed our first subject in the Crimson 1 Phase 3 registrational study of MarzAA, our next generation SQ FVIIa, in hemophilia A or B with inhibitors and are enrolling patients in a Phase 1/2 trial in other rare bleeding
First 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 C4b-degraders designed to target disorders of the classical complement pathway 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 statements about
the potential benefits of products based on Catalyst s engineered protease platform, plans to continue enrolling a Phase 3 open-label trial and a Phase 1/2 trial of MarzAA, submit the first report to the Data and Safety Monitoring Board (DSMB),
commence enrollment of an observational trial in CB 4332 in mid-2021 and a clinical trial in 2022, and the scope of the Company s intellectual property protection for its complement programs. 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, that additional human trials will
not replicate the results from earlier trials, that potential adverse effects may arise from the testing or use of MarzAA, including the generation of neutralizing antibodies, the risk that costs required to develop or manufacture the Company s
products will be higher than anticipated, including as a
result of delays in trial enrollment, development and manufacturing resulting from COVID-19 and other factors, the risk that the Company s patents may
be held invalid or may not provide the scope of coverage anticipated, competition and other risks described in the Risk Factors sections of the Company s Annual Report on Form 10-K filed with
the Securities and Exchange Commission on March 4, 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
Catalyst Biosciences, Inc.
Catalyst Biosciences, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| March 31, 2021 | December 31,2020 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 83,044 | $ | 30,360 | ||||
| Short-term investments | 23,956 | 48,994 | ||||||
| Accounts receivable | 1,006 | 3,313 | ||||||
| Prepaid and other current assets | 8,514 | 6,843 | ||||||
| Total current assets | 116,520 | 89,510 | ||||||
| Long-term investments | 2,543 | |||||||
| Other assets, noncurrent | 528 | 528 | ||||||
| Right-of-use assets | 1,646 | 1,832 | ||||||
| Property and equipment, net | 382 | 433 | ||||||
| Total assets | $ | 119,076 | $ | 94,846 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,956 | $ | 5,931 | ||||
| Accrued compensation | 2,232 | 2,476 | ||||||
| Deferred revenue | 1,332 | 1,983 | ||||||
| Other accrued liabilities | 6,983 | 6,743 | ||||||
| Operating lease liability | 678 | 663 | ||||||
| Total current liabilities | 14,181 | 17,796 | ||||||
| Operating lease liability, noncurrent | 806 | 981 | ||||||
| Total liabilities | 14,987 | 18,777 | ||||||
| Commitments and Contingencies (Note 10) | ||||||||
| 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; 31,331,027 and 22,097,820 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 31 | 22 | ||||||
| Additional paid-in capital | 441,252 | 390,803 | ||||||
| Accumulated other comprehensive income | 5 | 5 | ||||||
| Accumulated deficit | (337,199 | ) | (314,761 | ) | ||||
| Total stockholders equity | 104,089 | 76,069 | ||||||
| Total liabilities and stockholders equity | $ | 119,076 | $ | 94,846 |
Catalyst Biosciences, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended March 31, | Three Months Ended March 31, | |||||||
| 2021 | 2020 | |||||||
| License | $ | $ | 15,045 | |||||
| Collaboration | 1,467 | 1,321 | ||||||
| License and collaboration revenue | 1,467 | 16,366 | ||||||
| Operating expenses: | ||||||||
| Cost of license | 3,047 | |||||||
| Cost of collaboration | 1,480 | 1,432 | ||||||
| Research and development | 17,013 | 13,264 | ||||||
| General and administrative | 5,412 | 3,691 | ||||||
| Total operating expenses | 23,905 | 21,434 | ||||||
| Loss from operations | (22,438 | ) | (5,068 | ) | ||||
| Interest and other income (expense), net | 1,015 | |||||||
| Net loss | $ | (22,438 | ) | $ | (4,053 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.79 | ) | $ | (0.28 | ) | ||
| Shares used to compute net loss per share attributable to common stockholders, basic and diluted | 28,385,432 | 14,592,451 |