Full Press Release Details
Catalyst Biosciences Reports First Quarter 2020 Operating & Financial Results and Provides a Corporate Update
MarzAA Phase 3 study first patient enrollment targeted before year end following FDA and EMA regulatory feedback
DalcA Phase 2b study completed, final data to be presented in the second quarter
SOUTH SAN FRANCISCO, Calif. May 11, 2020 Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced its operating and
financial results for the first quarter ended March 31, 2020 and provided a corporate update.
Despite disruptions in clinical and preclinical
research operations affecting the biotechnology industry as the result of the COVID-19 pandemic, we have continued to make significant progress in both our MarzAA and DalcA programs, said Nassim Usman,
Ph.D., president and chief executive officer of Catalyst. We have incorporated guidance from FDA and EMA in our Phase 3 trial design for MarzAA and anticipate enrolling the first patient before the end of the year. We completed our Phase 2b
DalcA study and will present the final data before the end of the quarter. Dr. Usman continued, As we look forward, our solid financial position and progress across our portfolio give us confidence in our ability to advance our
programs through several important milestones. I would like to thank our study participants, collaborators, contractors and employees for their dedication and flexibility that has allowed us to advance the development of our new medicines as we face
these trying times together.
Expected Milestones:
First Quarter 2020 Results and Financial
About Catalyst Biosciences
Catalyst is a research and
clinical development biopharmaceutical company focused on addressing unmet needs in rare hematologic and systemic complement-mediated disorders. Our protease engineering platform includes development programs in hemophilia, a research program on
subcutaneous (SQ) systemic complement inhibitors and a partnered preclinical development program with Biogen for dry AMD. One of our key competitive advantages is that the product candidates generated by our protease engineering platform have
improved functionality and potency. These characteristics allow for improved dosing of our candidates including SQ systemic delivery of recombinant coagulation factors and complement inhibitors, low-dose high
activity gene therapy constructs and less frequently dosed intravitreal therapeutics. Our most advanced asset, SQ MarzAA has successfully completed Phase 2 development in prophylaxis, significantly reducing the annualized bleed rate (ABR) in
individuals with hemophilia A or B with inhibitors. Following regulatory guidance from the FDA and EMA, we recently announced the design of a Phase 3 registration study that is planned for late 2020. SQ dalcinonacog alfa (DalcA) is being developed
for the treatment of hemophilia B and has demonstrated efficacy and safety in a Phase 2b clinical trial that has completed dosing and all participant activities. We have an early 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 for the potential treatment of geographic atrophy-associated dry age-related macular degeneration. For more information, please visit
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements about
plans to enroll the first patient in the Phase 3 trial of MarzAA before year-end, plans to present final results from the Phase 2b clinical trial of DalcA and non-human
primate data of CB 2679d-GT during the second quarter of 2020, the potential for positive results from the Phase 2b clinical trial of DalcA and for SQ DalcA to change the treatment paradigm for hemophilia B,
the potential uses and benefits of MarzAA and DalcA to effectively and therapeutically treat hemophilia subcutaneously, 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.
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 COVID-19 virus and other factors, that trials may not have satisfactory
outcomes, that complete data from the Phase 2b trial of DalcA may not replicate previously reported partial results or 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 COVID-19 and other factors, the risk that Biogen will terminate Catalyst s agreement with them, competition and
other risks described in the Risk Factors section of the Company s quarterly report filed with the Securities and Exchange Commission on May 11, 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)
| March 31, 2020 | December 31, 2019 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 70,364 | $ | 15,369 | ||||
| Short-term investments | 34,164 | 61,496 | ||||||
| Accounts receivable | 1,366 | 15,000 | ||||||
| Prepaid and other current assets | 2,381 | 4,201 | ||||||
| Total current assets | 108,275 | 96,066 | ||||||
| Other assets, noncurrent | 197 | 257 | ||||||
| Right-of-use assets | 1,795 | 1,927 | ||||||
| Property and equipment, net | 296 | 304 | ||||||
| Total assets | $ | 110,563 | $ | 98,554 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,316 | $ | 4,279 | ||||
| Accrued compensation | 1,268 | 2,106 | ||||||
| Deferred revenue | 15,000 | |||||||
| Other accrued liabilities | 8,774 | 7,031 | ||||||
| Operating lease liability | 495 | 483 | ||||||
| Total current liabilities | 11,853 | 28,899 | ||||||
| Operating lease liability, noncurrent | 1,191 | 1,319 | ||||||
| Total liabilities | 13,044 | 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; 17,419,313 and 12,040,835 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 17 | 12 | ||||||
| Additional paid-in capital | 359,935 | 326,810 | ||||||
| Accumulated other comprehensive income | 140 | 34 | ||||||
| Accumulated deficit | (262,573 | ) | (258,520 | ) | ||||
| Total stockholders equity | 97,519 | 68,336 | ||||||
| Total liabilities and stockholders equity | $ | 110,563 | $ | 98,554 |
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, | |||||||
| 2020 | 2019 | |||||||
| License | $ | 15,045 | $ | |||||
| Collaboration | 1,321 | |||||||
| License and collaboration revenue | 16,366 | |||||||
| Operating expenses: | ||||||||
| Cost of license | 3,047 | |||||||
| Cost of collaboration | 1,432 | |||||||
| Research and development | 13,264 | 12,027 | ||||||
| General and administrative | 3,691 | 3,687 | ||||||
| Total operating expenses | 21,434 | 15,714 | ||||||
| Loss from operations | (5,068 | ) | (15,714 | ) | ||||
| Interest and other income, net | 1,015 | 631 | ||||||
| Net loss | $ | (4,053 | ) | (15,083 | ) | |||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.28 | ) | $ | (1.26 | ) | ||
| Shares used to compute net loss per share attributable to common stockholders, basic and diluted | 14,592,451 | 11,963,586 |