Full Press Release Details
Catalyst Biosciences Reports Third Quarter 2019 Operating & Financial Results and
Provides a Corporate Update
FRANCISCO, Calif. November 7, 2019 Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced its operating and financial results for the third quarter ended September 30, 2019 and provided a corporate
We continued to make progress in both the marzeptacog alfa (activated) (MarzAA FVIIa) and dalcinonacog alfa (DalcA FIX)
clinical programs said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. We presented final MarzAA Phase 2 clinical data that clearly demonstrated the potential for subcutaneously (SQ) dosed MarzAA as a prophylactic
treatment for hemophilia A or B patients with inhibitors. In addition, we showed that SQ MarzAA can treat a bleed in a preclinical model and completed GMP manufacturing of MarzAA at commercial scale, important steps as we prepare for a pivotal Phase
3 trial in 2020. In the DalcA Phase 2b trial, we successfully completed dosing in two subjects, achieving high FIX activity levels with a long SQ half-life without eliciting anti-drug antibodies (ADAs).
Presented final Phase 2 data for MarzAA at ISTH in July: The study met the primary
endpoint of significantly reducing (>90%) the annualized bleed rate (ABR) in patients with hemophilia A or B with inhibitors from 19.8 to 1.6 (p<0.01). The study also met all secondary endpoints of safety, tolerability and absence of ADAs or
inhibitor formation. Additionally, the Proportion of Days with Bleeding (PDB), was significantly reduced from a 6-month pretreatment mean of 12.3% to 0.8% during treatment (p<0.01). The median ABR and PDB
were both reduced to zero during treatment, with seven of nine subjects experiencing no bleeds, either traumatic or spontaneous, at their final dose level. Subcutaneous treatment with MarzAA was safe and well-tolerated. Six mild to moderate
localized skin reactions were observed in 2 subjects. No ADAs or inhibitors to MarzAA were detected after administration of a total of 517 SQ doses.
Hosted a Key Opinion Leader meeting in August highlighting the current treatment landscape, market opportunity and unmet medical need for
MarzAA in treating individuals with hemophilia A or B with inhibitors, Factor VII deficiency and other bleeding disorders, and the potential for an SQ therapy to treat bleeding.
Completed a GMP drug product batch at commercial scale that is expected to support pivotal studies and commercialization requirements.
Continued to enroll a Phase 1 SQ pharmacokinetic and pharmacodynamic study of MarzAA in individuals with hemophilia A or B (with or without
inhibitors). The purpose of the trial is to guide dose selection to treat a bleed with SQ dosing.
Completed 28-day SQ dosing and
30-day washout and safety follow-up of two subjects in the open-label Phase 2b study evaluating the efficacy and safety of DalcA with long-term dosing in individuals
with severe hemophilia B. Factor IX levels in these two subjects exceeded the efficacy endpoint of >12% activity and no ADAs or inhibitors were detected. Enrollment is ongoing and the Company anticipates reporting final data in the first half of
Expected Milestones:
Third Quarter 2019 Results and Financial Highlights:
About Catalyst Biosciences
Catalyst is a clinical-stage biopharmaceutical company developing novel medicines to address hematology indications. Catalyst has engineered a portfolio of
compounds that have increased potency over the naturally occurring proteases. Catalyst is focused on the field of hemostasis, including the subcutaneous treatment of hemophilia and facilitating surgery in individuals with hemophilia. For more
information, please visit www.catalystbiosciences.com.
Forward-Looking Statements
This press release may contain forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements about
the potential uses and benefits of Catalyst s products in development to address hemophilia indications, plans to initiate a Phase 3 MarzAA trial following the planned FDA End of Phase 2 meeting, plans to report data from the MarzAA Phase 1
pharmacokinetic and pharmacodynamic study in 2020, statements about Catalyst s clinical trial plans for DalcA, the timing of the clinical trial, anticipated reporting of data in the first half of 2020, and the potential for the DalcA 2b trial
to meet its endpoints. 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 and 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 antibodies, which has been observed in patients previously treated with DalcA, the risk that costs required to develop or manufacture the Company s products will be
higher than anticipated, competition and other factors that affect the Company s ability to establish collaborations on commercially reasonable terms and other risks described in the Risk Factors section of the Company s
quarterly report filed with the Securities and Exchange Commission on November 7, 2019, 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)
| September 30, 2019 | December 31, 2018 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 23,018 | $ | 31,213 | ||||
| Short-term investments | 61,928 | 88,914 | ||||||
| Restricted cash | 50 | |||||||
| Prepaid and other current assets | 4,188 | 3,814 | ||||||
| Total current assets | 89,138 | 123,991 | ||||||
| Other assets, noncurrent | 257 | 543 | ||||||
| Right-of-use assets | 2,058 | |||||||
| Property and equipment, net | 339 | 386 | ||||||
| Total assets | $ | 91,792 | $ | 124,920 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,123 | $ | 1,248 | ||||
| Accrued compensation | 1,576 | 1,495 | ||||||
| Other accrued liabilities | 4,906 | 2,043 | ||||||
| Deferred rent, current portion | 15 | |||||||
| Operating lease liability | 472 | |||||||
| Total current liabilities | 9,077 | 4,801 | ||||||
| Operating lease liability, noncurrent | 1,443 | |||||||
| Deferred rent, noncurrent portion | 174 | |||||||
| Total liabilities | 10,520 | 4,975 | ||||||
| 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; 12,029,992 and 11,954,528 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 12 | 12 | ||||||
| Additional paid-in capital | 326,139 | 323,279 | ||||||
| Accumulated other comprehensive income (loss) | 31 | (4 | ) | |||||
| Accumulated deficit | (244,910 | ) | (203,342 | ) | ||||
| Total stockholders equity | 81,272 | 119,945 | ||||||
| Total liabilities and stockholders equity | $ | 91,792 | $ | 124,920 |
Catalyst Biosciences, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Contract revenue | $ | $ | $ | $ | 6 | |||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 9,927 | 5,575 | 33,066 | 13,235 | ||||||||||||
| General and administrative | 3,268 | 2,770 | 10,224 | 8,909 | ||||||||||||
| Total operating expenses | 13,195 | 8,345 | 43,290 | 22,144 | ||||||||||||
| Loss from operations | (13,195 | ) | (8,345 | ) | (43,290 | ) | (22,138 | ) | ||||||||
| Interest and other income, net | 489 | 651 | 1,722 | 2,920 | ||||||||||||
| Net loss | $ | (12,706 | ) | $ | (7,694 | ) | (41,568 | ) | (19,218 | ) | ||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (1.06 | ) | $ | (0.64 | ) | $ | (3.47 | ) | $ | (1.75 | ) | ||||
| Shares used to compute net loss per share attributable to common stockholders, basic and diluted | 12,022,620 | 11,942,729 | 11,992,240 | 10,967,750 |
The accompanying notes are an integral part of these condensed consolidated financial statements.