Full Press Release Details
Catalyst Biosciences Reports Second Quarter 2020 Operating & Financial Results and Provides a Corporate Update
SOUTH SAN FRANCISCO, Calif. August 6, 2020 Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced its operating and
financial results for the second quarter ended June 30, 2020 and provided a corporate update.
We continued to make significant progress across
our pipeline, delivering on all milestones during the first half of the year, said Nassim Usman, Ph.D., president and chief executive officer of Catalyst Biosciences. We are currently on track to achieve additional important milestones
in the second half of 2020 including enrolling patients in our pivotal Phase 3 study of subcutaneous (SQ) MarzAA treatment of bleeding in individuals with hemophilia A or B with inhibitors. Further, we expect to identify development candidates in
our complement and gene therapy programs. We closed the quarter with approximately $117 million in cash putting us in a strong position to deliver on these upcoming milestones.
Expected Milestones:
Second Quarter 2020 Results and Financial Highlights:
About Catalyst Biosciences
Catalyst is a research and
clinical development biopharmaceutical company focused on addressing unmet needs in rare hematologic and complement-mediated disorders. Our protease engineering platform includes two late-stage clinical programs in hemophilia; a research program on
engineering of subcutaneous (SQ) complement inhibitors; and a partnered preclinical development program with Biogen for dry age-related macular degeneration (AMD). The product candidates generated by our
protease engineering platform have improved functionality and potency that allow for: SQ administration of recombinant coagulation factors and complement inhibitors; low-dose, high activity gene therapy
constructs; and less frequently dosed intravitreal therapeutics. Our most advanced product candidate is marzeptacog alfa (activated) (MarzAA), a next-generation SQ FVIIa entering a Phase 3 registration study in late 2020. Our next late-stage product
candidate is dalcinonacog alfa (DalcA), a next-generation SQ FIX, which has demonstrated efficacy and safety in a Phase 2b clinical trial in individuals with Hemophilia B. We have a discovery stage Factor IX gene therapy construct - CB 2679d-GT - for Hemophilia B, that has demonstrated superiority compared with the Padua variant in preclinical models. Finally, we have a global license and collaboration agreement with Biogen for the development and
commercialization of anti-complement Factor 3 (C3) pegylated CB 2782.
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 enroll the first patients in a Phase 3 registration study of MarzAA to treat episodic bleeding in individuals with hemophilia A or B with inhibitors,
initiate a Phase 1/2 trial in FVII Deficiency, Glanzmann Thrombastenia, and patients treated with Hemlibra in late 2020, the potential for MarzAA and DalcA to effectively and therapeutically treat hemophilia subcutaneously, plans to declare
development candidates in our Factor IX Gene Therapy and systemic complement programs, the superiority of CB 2679d-GT over other gene therapy candidates and the Company s collaboration with Biogen for the
development and commercialization of pegylated CB 2782 for the potential treatment of geographic atrophy-associated dry age-related macular degeneration (AMD). 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 the novel coronavirus (COVID-19) outbreak 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 DalcA or MarzAA, including the generation of neutralizing antibodies, which has been observed in patients treated with DalcA, 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 development and manufacturing resulting from
SARS-CoV-2 and other factors, the risk that Biogen will terminate Catalyst s agreement, competition and other risks described in the Risk Factors
section of the Company s quarterly report filed with the Securities and Exchange Commission on August 6, 2020, 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, 2020 | December 31, 2019 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 59,273 | $ | 15,369 | ||||
| Short-term investments | 58,091 | 61,496 | ||||||
| Accounts receivable | 1,988 | 15,000 | ||||||
| Prepaid and other current assets | 1,993 | 4,201 | ||||||
| Total current assets | 121,345 | 96,066 | ||||||
| Other assets, noncurrent | 198 | 257 | ||||||
| Right-of-use assets | 1,660 | 1,927 | ||||||
| Property and equipment, net | 481 | 304 | ||||||
| Total assets | $ | 123,684 | $ | 98,554 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,499 | $ | 4,279 | ||||
| Accrued compensation | 1,778 | 2,106 | ||||||
| Deferred revenue | 330 | 15,000 | ||||||
| Other accrued liabilities | 9,550 | 7,031 | ||||||
| Operating lease liability | 507 | 483 | ||||||
| Total current liabilities | 13,664 | 28,899 | ||||||
| Operating lease liability, noncurrent | 1,059 | 1,319 | ||||||
| Total liabilities | 14,723 | 30,218 | ||||||
| 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; 22,050,745 and 12,040,835 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | 22 | 12 | ||||||
| Additional paid-in capital | 388,719 | 326,810 | ||||||
| Accumulated other comprehensive income | 41 | 34 | ||||||
| Accumulated deficit | (279,821 | ) | (258,520 | ) | ||||
| Total stockholders equity | 108,961 | 68,336 | ||||||
| Total liabilities and stockholders equity | $ | 123,684 | $ | 98,554 |
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, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| License | $ | 23 | $ | $ | 15,068 | $ | ||||||||||
| Collaboration | 1,635 | 2,956 | ||||||||||||||
| License and collaboration revenue | 1,658 | 18,024 | ||||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of license | 23 | 3,070 | ||||||||||||||
| Cost of collaboration | 1,719 | 3,151 | ||||||||||||||
| Research and development | 12,906 | 11,111 | 26,170 | 23,138 | ||||||||||||
| General and administrative | 4,371 | 3,270 | 8,062 | 6,956 | ||||||||||||
| Total operating expenses | 19,019 | 14,381 | 40,453 | 30,094 | ||||||||||||
| Loss from operations | (17,361 | ) | (14,381 | ) | (22,429 | ) | (30,094 | ) | ||||||||
| Interest and other income, net | 113 | 601 | 1,128 | 1,232 | ||||||||||||
| Net loss | $ | (17,248 | ) | $ | (13,780 | ) | $ | (21,301 | ) | $ | (28,862 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.96 | ) | $ | (1.15 | ) | $ | (1.31 | ) | $ | (2.41 | ) | ||||
| Shares used to compute net loss per share attributable to common stockholders, basic and diluted | 17,891,475 | 11,989,866 | 16,241,963 | 11,976,799 |