Full Press Release Details
Catalyst Biosciences Reports Fourth Quarter and Full-Year 2018 Operating &
Financial Results and Provides a Corporate Update
Completed enrollment of the MarzAA SQ Phase 2 trial and demonstrated safety and clinical
efficacy, with >90% reduction in bleeding
Completed a full immunogenicity analysis for DalcA, plan to initiate a
Phase 2b 28-day SQ trial in March 2019
SOUTH SAN FRANCISCO, Calif. Mar. 7, 2019 Catalyst Biosciences, Inc. (NASDAQ: CBIO), today announced its operating and financial results
for the fourth quarter and full-year ending December 31, 2018 and provided a corporate update.
2019 will be a very exciting year for Catalyst
with several clinical and regulatory read outs expected throughout the year, said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. Both Phase 2 trials demonstrate that our therapies are clinically efficacious when
dosed subcutaneously, which we believe is the future for hemophilia treatments. Subcutaneous MarzAA and DalcA have the potential to be disruptive to current intravenous products, an approximately $3.4 billion market, and they are especially
well-suited for children.
Fourth Quarter and Full-year 2018 Results and Financial Highlights
About Catalyst Biosciences
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address serious medical conditions for individuals who need new
or better treatment options. We are focusing our product development efforts in the field of hemostasis (the process that regulates bleeding) and have a mission to develop valuable therapies for 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
the potential commercial market for DalcA and MarzAA, the relative safety of DalcA compared with BeneFIX and other recombinant Factor IX products, Catalyst s plans to commence a Phase 2b clinical trial of DalcA in March 2019 and have top-line and final data readouts in Q3 and Q4, 2019, respectively, the potential for DalcA to provide a conveniently-dosed subcutaneous prophylactic treatment option for patients suffering from hemophilia B, the
potential for MarzAA to provide prophylaxis therapy in patients with hemophilia A or B with inhibitors, and plans to complete the Phase 2 clinical trial and a Phase 1 PK/PD study of MarzAA in 2019. Forward looking statements also include
Catalyst s plans to determine preclinical efficacy for CB 2679d-GT in 2019 and develop CB2782 towards a pre-clinical candidate in 2019. 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 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 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 Annual Report
on Form 10-K for the quarter and the year ended December 31, 2018 filed with the Securities and Exchange Commission on March 7, 2019, and 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.
Consolidated Balance Sheets
(In thousands, except shares and per share amounts)
| December 31, 2018 | December 31, 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 31,213 | $ | 14,472 | ||||
| Short-term investments | 88,914 | 17,971 | ||||||
| Restricted cash | 50 | 5,333 | ||||||
| Prepaid and other current assets | 3,814 | 1,333 | ||||||
| Total current assets | 123,991 | 39,109 | ||||||
| Other assets, noncurrent | 543 | 128 | ||||||
| Property and equipment, net | 386 | 276 | ||||||
| Total assets | $ | 124,920 | $ | 39,513 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,248 | $ | 747 | ||||
| Accrued compensation | 1,495 | 1,366 | ||||||
| Other accrued liabilities | 2,043 | 1,322 | ||||||
| Deferred revenue, current portion | 212 | |||||||
| Deferred rent, current portion | 15 | 7 | ||||||
| Redeemable convertible notes | 5,085 | |||||||
| Total current liabilities | 4,801 | 8,739 | ||||||
| Deferred rent, noncurrent portion | 174 | |||||||
| Total liabilities | 4,975 | 8,739 | ||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.001 par value, 5,000,000 shares authorized; 0 and 3,680 shares issued and outstanding at December 31, 2018 and 2017, respectively | ||||||||
| Common stock, $0.001 par value, 100,000,000 shares authorized; 11,954,528 and 6,081,230 shares issued and outstanding at December 31, 2018 and 2017, respectively | 12 | 6 | ||||||
| Additional paid-in capital | 323,279 | 204,262 | ||||||
| Accumulated other comprehensive loss | (4 | ) | ||||||
| Accumulated deficit | (203,342 | ) | (173,494 | ) | ||||
| Total stockholders equity | 119,945 | 30,774 | ||||||
| Total liabilities and stockholders equity | $ | 124,920 | $ | 39,513 |
Catalyst Biosciences, Inc.
Consolidated Statements of Operations
(In thousands, except shares and per share amounts)
| Year Ended December 31, | ||||||||
| 2018 | 2017 | |||||||
| Contract revenue | $ | 6 | $ | 1,018 | ||||
| Operating expenses: | ||||||||
| Research and development | 21,474 | 12,847 | ||||||
| General and administrative | 12,354 | 9,993 | ||||||
| Total operating expenses | 33,828 | 22,840 | ||||||
| Loss from operations | (33,822 | ) | (21,822 | ) | ||||
| Interest and other income, net | 3,767 | 261 | ||||||
| Net loss | (30,055 | ) | (21,561 | ) | ||||
| Deemed dividend for convertible preferred stock beneficial conversion feature | (3,951 | ) | ||||||
| Net loss attributable to common stockholders | $ | (30,055 | ) | $ | (25,512 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (2.68 | ) | $ | (7.45 | ) | ||
| Shares used to compute net loss per share attributable to common stockholders, basic and diluted | 11,213,884 | 3,423,901 |