Full Press Release Details
Catalyst Biosciences Reports Second Quarter 2019 Operating & Financial Results and
Provides a Corporate Update
Phase 2 trial of subcutaneously administered MarzAA met primary endpoint of reduction in
annualized bleed rate demonstrating safety and clinical efficacy, with >90% reduction in bleeding
DalcA Phase 2b study ongoing and enrolling patients
SOUTH SAN FRANCISCO, Calif. August 1, 2019 Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced its operating and financial results
for the second quarter ended June 30, 2019 and provided a corporate update.
We continue to focus on advancing the clinical development for MarzAA
and DalcA, said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. In July, we presented final data from our Phase 2 trial of MarzAA at the ISTH meeting. The data demonstrated MarzAA s ability to reduce median
bleeds to zero with daily subcutaneous prophylactic therapy. MarzAA has the potential to enable individuals with hemophilia A or B with inhibitors to lead more normal, active lives. We look forward to an end of Phase 2 meeting on MarzAA with the
Expected Milestones:
Second Quarter 2019 Results and Financial Highlights:
About Catalyst Biosciences
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel treatments for hemophilia and other rare bleeding disorders using its potent, subcutaneous (SQ) coagulation factors that promote blood clotting.
The Company s engineered coagulation factors are designed to overcome the significant limitations of current intravenous (IV) treatment options, facilitate prophylaxis, and ultimately deliver substantially better outcomes for patients
using SQ dosing. For more information, please visit www.catalystbiosciences.com.
This press release contains forward-looking statements that involve substantial risks and
uncertainties. Forward-looking statements include statements about the potential use of MarzAA as a prophylactic therapy for patients with hemophilia A or B with inhibitors, clinical trial results for MarzAA,
plans to request an FDA End of Phase 2 meeting, plans to report data from the MarzAA Phase 1 pharmacokinetic and pharmacodynamic study in 2020, clinical trial plans for DalcA and plans to provide topline data from the ongoing Phase 2b study in Q4
2019 and final data in 2020, and immunogenicity risks of DalcA. 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 additional human trials will not replicate the results from earlier trials, that potential
adverse effects may arise from the testing or use of MarzAA or DalcA, including the generation of antibodies, which has been observed in patients treated with DalcA, the risk that enrollment of clinical trials may be slower than expected, the risk
that the FDA will not grant an end of Phase 2 meeting for MarzAA, the risk that costs required to develop or manufacture the Company s products will be higher than anticipated, competition and other factors that affect our ability to establish
collaborations on commercially reasonable terms and other risks described in the Risk Factors section of the Company s Form 10-K filed with the Securities and Exchange Commission on March 8,
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.
Josephine Belluardo, Ph.D.
LifeSci Public Relations
Catalyst Biosciences, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| June 30, 2019 | December 31, 2018 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 17,348 | $ | 31,213 | ||||
| Short-term investments | 76,587 | 88,914 | ||||||
| Restricted cash | 50 | 50 | ||||||
| Prepaid and other current assets | 4,072 | 3,814 | ||||||
| Total current assets | 98,057 | 123,991 | ||||||
| Other assets, noncurrent | 257 | 543 | ||||||
| Right-of-use assets | 2,188 | |||||||
| Property and equipment, net | 371 | 386 | ||||||
| Total assets | $ | 100,873 | $ | 124,920 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 393 | $ | 1,248 | ||||
| Accrued compensation | 1,410 | 1,495 | ||||||
| Other accrued liabilities | 3,932 | 2,043 | ||||||
| Deferred rent, current portion | 15 | |||||||
| Operating lease liability | 461 | |||||||
| Total current liabilities | 6,196 | 4,801 | ||||||
| Operating lease liability, noncurrent | 1,566 | |||||||
| Deferred rent, noncurrent portion | 174 | |||||||
| Total liabilities | 7,762 | 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; 12,008,528 and 11,954,528 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 12 | 12 | ||||||
| Additional paid-in capital | 325,246 | 323,279 | ||||||
| Accumulated other comprehensive income (loss) | 57 | (4 | ) | |||||
| Accumulated deficit | (232,204 | ) | (203,342 | ) | ||||
| Total stockholders equity | 93,111 | 119,945 | ||||||
| Total liabilities and stockholders equity | $ | 100,873 | $ | 124,920 |
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, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Contract revenue | $ | $ | $ | $ | 6 | |||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 11,111 | 3,889 | 23,138 | 7,660 | ||||||||||||
| General and administrative | 3,270 | 3,225 | 6,956 | 6,139 | ||||||||||||
| Total operating expenses | 14,381 | 7,114 | 30,094 | 13,799 | ||||||||||||
| Loss from operations | (14,381 | ) | (7,114 | ) | (30,094 | ) | (13,793 | ) | ||||||||
| Interest and other income, net | 601 | 632 | 1,232 | 2,269 | ||||||||||||
| Net loss | $ | (13,780 | ) | $ | (6,482 | ) | (28,862 | ) | (11,524 | ) | ||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (1.15 | ) | $ | (0.54 | ) | $ | (2.41 | ) | $ | (1.10 | ) | ||||
| Shares used to compute net loss per share attributable to common stockholders, basic and diluted | 11,989,866 | 11,938,401 | 11,976,799 | 10,472,180 |