Catalyst Biosciences Reports Third Quarter Operating & Financial Results and Provides a Corporate Update
Presented Updated Positive Interim Data from the Phase 2/3 Study of Marzeptacog Alfa (Activated) (FVIIa) at Two Scientific Meetings
Published Data from Phase 1 Study of Marzeptacog Alfa (Activated) in the
Ended Q3 with a cash balance of
Recent Milestones:
- Reported positive interim data from its Phase 2/3 study of subcutaneous (SQ) prophylactic Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA), being developed for the treatment of hemophilia A or B with inhibitors at the 2018 meeting of the
International Society for Thrombosis & Hemostasis (ISTH) inDublin, Ireland onJuly 18 th and presented updated data in the Subcutaneous Delivery of Coagulation Factors session at the 2018 Hemophilia Drug Development Summit (HDDS) inBoston, MA onAugust 15 th.
- Published data from the Phase 1 trial of MarzAA in individuals with hemophilia A or B with or without inhibitors in the peer-reviewed
Journal of Thrombosis & Haemostasis . The paper, entitled: “Phase 1, single-dose escalating study of marzeptacog alfa (activated), a recombinant factor VIIa variant, in patients with severe hemophilia,” described the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending intravenous (IV) bolus doses of MarzAA.
- Initiated a comprehensive review of the Cohort 6 neutralizing antibody (nAb) observation from the Phase 1/2 study of Factor IX (FIX) variant dalcinonacog alfa (DalcA). We are planning to provide further updates on these analyses later in 2018.
“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
Upcoming Milestones
- Interim analysis from the Phase 2/3 MarzAA study at ASH 2018.
- Additional data and analysis of the cause and impact of the antibody observations in Cohort 6 of the dalcinonacog alfa (DalcA) Phase 1/2 trial in December 2018.
Second Quarter 2018 Results and Financial Highlights
- Cash, cash equivalents and short-term investments, as of
September 30, 2018 were$129.2 million due primarily to the approximately$106.8 million in net financing inFebruary 2018 and$9.5 million in proceeds from the exercise of warrants during the first quarter 2018.
- Research and development expense for the three months ended
September 30, 2018 was$5.6 million , compared with$3.8 million for the prior year period. The increase was due primarily to personnel-related costs, preclinical third-party research and development service contracts and manufacturing expenses for MarzAA and DalcA.
- General and administrative expense for the three months ended
September 30, 2018 was$2.8 million compared with$2.4 million for the prior year period. The increase was due primarily to personnel related expenses and professional service costs.
- Interest and other income for the three months ended
September 30, 2018 was$0.7 million , compared with$0.1 million for the prior year period. The increase was due primarily to investment and dividend income.
- Net loss attributable to common stockholders for the three months ended
September 30, 2018 was$7.7 million , or($0.64) per basic and diluted share, compared with$5.8 million , or($1.34) per basic and diluted share, for the prior year period.
- On
February 19, 2018 , the final$5 million of the company’s redeemable convertible notes matured and were repaid in full with$5 million from the company’s restricted cash. The Company has no outstanding notes or debt.
- As of
September 30, 2018 , the Company had 11,942,729 shares of common stock outstanding.
About
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
Contacts:
Investors:
1.650.871.0761
investors@catbio.com
Media:
LifeSci Public Relations
1.646.751.4361
jo@lifescipublicrelations.com
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 | ||||
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
| 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 | ||||||||||||
Source: Catalyst Biosciences, Inc.
