Full Press Release Details
Catalyst Biosciences Reports Third Quarter Operating & Financial Results and Provides a Corporate
Presented Updated Positive Interim Data from the Phase 2/3 Study of Marzeptacog Alfa (Activated) (FVIIa) at Two Scientific
Published Data from Phase 1 Study of Marzeptacog Alfa (Activated) in the Journal of Thrombosis & Haemostasis
Ended Q3 with a cash balance of ~$129M
SOUTH SAN FRANCISCO, Calif. November 1, 2018 Catalyst Biosciences, Inc. (NASDAQ: CBIO), today announced operating and
financial results for the third quarter ending September 30, 2018 and provided a corporate update.
We had an active third quarter in which we presented interim data on our ongoing Phase 2/3 SQ study of MarzAA at the 2018 ISTH & HDDS meetings
and published data from our Phase 1 IV trial of MarzAA in the Journal of Thrombosis & Haemostasis, said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. We are very encouraged by the
interim data from the Phase 2/3 study of MarzAA and plan to complete enrollment of the Phase 2 portion by the end of 2018. Simultaneously, we initiated an analysis of the nAb results from the Phase 1/2 study of dalcinonacog alfa (DalcA)(formerly CB
2679d/ISU304) Factor IX program. Our Q3 ending cash balance of $129M allows us to continue the independent development of our subcutaneous prophylactic MarzAA and DalcA candidates.
Second Quarter 2018 Results and Financial Highlights
About Catalyst Biosciences
Catalyst is a clinical-stage biopharmaceutical company developing novel medicines to address hematology indications. Catalyst is focused on the field of
hemostasis, including the subcutaneous prophylaxis of hemophilia and facilitating surgery in individuals with hemophilia. For more information, please visit www.catalystbiosciences.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements about
development plans for Catalyst s MarzAA and DalcA, including the potential completion of the Phase 2 portion of the Phase 2/3 trial of MarzAA by the end of 2018, plans to present interim analysis from this trial at ASH 2018, plans to complete
the ongoing analysis of nAbs for DalcA by December 2018, and the potential resumption of clinical trials 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 from the forward-looking statements that the Company makes, including, but not limited to, the risk that trials and studies may be
delayed and may not have satisfactory outcomes, that the ongoing Phase 2/3 efficacy trial may not replicate the results from earlier studies, that potential adverse effects may arise from the testing or use of MarzAA, including the generation of
antibodies, that the analysis of the nAbs observed in the Phase 1/2 trial of DalcA or other factors lead us not to resume clinical trials of 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 our ability to establish collaborations on commercially reasonable terms and other risks described in the Risk Factors section of the Company s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, filed with the Securities and Exchange Commission on August 2, 2018, along with 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)
| September 30, 2018 | December 31, 2017 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 35,998 | $ | 14,472 | ||||
| Short-term investments | 93,223 | 17,971 | ||||||
| Restricted cash | 50 | 5,333 | ||||||
| Prepaid and other current assets | 3,538 | 1,333 | ||||||
| Total current assets | 132,809 | 39,109 | ||||||
| Other assets, noncurrent | 352 | 128 | ||||||
| Property and equipment, net | 255 | 276 | ||||||
| Total assets | $ | 133,416 | $ | 39,513 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 369 | $ | 747 | ||||
| Accrued compensation | 1,082 | 1,366 | ||||||
| Other accrued liabilities | 1,840 | 1,322 | ||||||
| Deferred revenue | 212 | |||||||
| Deferred rent, current portion | 13 | 7 | ||||||
| Redeemable convertible notes | 5,085 | |||||||
| Total current liabilities | 3,304 | 8,739 | ||||||
| Deferred rent, noncurrent portion | 161 | |||||||
| Total liabilities | 3,465 | 8,739 | ||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.001 par value, 5,000,000 shares authorized; 0 and 3,680 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively | ||||||||
| Common stock, $0.001 par value, 100,000,000 shares authorized; 11,942,729 and 6,081,230 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively | 12 | 6 | ||||||
| Additional paid-in capital | 322,468 | 204,262 | ||||||
| Accumulated other comprehensive income | (24 | ) | ||||||
| Accumulated deficit | (192,505 | ) | (173,494 | ) | ||||
| Total stockholders equity | 129,951 | 30,774 | ||||||
| Total liabilities and stockholders equity | $ | 133,416 | $ | 39,513 |
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, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Contract revenue | $ | $ | 318 | $ | 6 | $ | 700 | |||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,575 | 3,805 | 13,235 | 9,286 | ||||||||||||
| General and administrative | 2,770 | 2,391 | 8,909 | 7,407 | ||||||||||||
| Total operating expenses | 8,345 | 6,196 | 22,144 | 16,693 | ||||||||||||
| Loss from operations | (8,345 | ) | (5,878 | ) | (22,138 | ) | (15,993 | ) | ||||||||
| Interest and other income, net | 651 | 85 | 2,920 | 185 | ||||||||||||
| Net loss | $ | (7,694 | ) | $ | (5,793 | ) | (19,218 | ) | (15,808 | ) | ||||||
| Deemed dividend for convertible preferred stock beneficial conversion feature | (3,951 | ) | ||||||||||||||
| Net loss attributable to common stockholders | $ | (7,694 | ) | $ | (5,793 | ) | $ | (19,218 | ) | $ | (19,759 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.64 | ) | $ | (1.34 | ) | $ | (1.75 | ) | $ | (6.49 | ) | ||||
| Shares used to compute net loss per share attributable to common stockholders, basic and diluted | 11,942,729 | 4,310,561 | 10,967,750 | 3,043,919 |