Full Press Release Details
| Exhibit 99.1 |
| NEWS RELEASE |
Catalyst Biosciences Reports Third Quarter 2017 Operating & Financial Results and Provides Corporate Update
-- Phase 1/2 trial of Factor IX CB 2679d is advancing with interim results expected by year-end -
-- Phase 2 trial of Factor FVIIa marzeptacog alfa (activated) on track for initiation by year-end--
SOUTH SAN FRANCISCO, Calif. - November 2, 2017 - Catalyst Biosciences, Inc. (NASDAQ: CBIO), today announced operating and financial results for the third quarter ended Sept. 30, 2017, and provided a corporate update.
Recent Milestones: Factor IX CB 2679d product candidate (also known as ISU304)
"We have made steady progress with the clinical development of our coagulation Factor IX hemophilia product candidate, and we look forward to presenting interim results from the ongoing Phase 1/2 subcutaneous dosing study in individuals with hemophilia B at the American Society of Hematology on Dec. 9, as we announced yesterday" said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. "This is an exciting time for the company as we continue towards near-term data milestones and longer-term program development for both our Factor IX and FVIIa programs."
| Exhibit 99.1 |
| NEWS RELEASE |
Third Quarter 2017 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.catbio.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, the potential uses and benefits of CB 2679d and marzeptacog alfa (activated) and development plans for these product candidates are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Catalyst's clinical trial timelines, including the initiation of a Phase 2/3 efficacy trial for marzeptacog alfa (activated) in 2017, the anticipated announcement of top-line results from the subcutaneous CB 2679d Phase 1/2 proof-of-concept trial by the first quarter of 2018, the anticipated announcement of interim results from the marzeptacog alpha (activated) Phase 2 clinical trial in the first half of 2018, potential uses and benefits of subcutaneously dosed marzeptacog alfa (activated) or CB 2679d, and the Company's belief regarding sufficiency of its existing capital resources to meet its projected operating requirements for at least the next 12 months. 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 Catalyst makes, including, but not limited to, the risk that clinical trials and studies may be
| Exhibit 99.1 |
| NEWS RELEASE |
delayed and may not have satisfactory outcomes, that potential adverse effects may arise from the testing or use of Catalyst's products, the risk that costs required to develop or manufacture Catalyst's products will be higher than anticipated, competition and other factors that affect our ability to successfully develop and commercialize our product candidates, and other risks described in the "Risk Factors" section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. Catalyst 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
| Exhibit 99.1 |
| NEWS RELEASE |
Catalyst Biosciences, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| September 30, 2017 | December 31, 2016 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 10,973 | $ | 10,264 | ||||
| Short-term investments | 16,477 | 6,800 | ||||||
| Restricted cash | 5,727 | 19,468 | ||||||
| Accounts receivable | 52 | 31 | ||||||
| Prepaid and other current assets | 849 | 958 | ||||||
| Total current assets | 34,078 | 37,521 | ||||||
| Restricted cash, noncurrent | - | 125 | ||||||
| Property and equipment, net | 315 | 444 | ||||||
| Total assets | $ | 34,393 | $ | 38,090 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,460 | $ | 837 | ||||
| Accrued compensation | 920 | 596 | ||||||
| Other accrued liabilities | 1,095 | 805 | ||||||
| Deferred revenue, current portion | 530 | 283 | ||||||
| Deferred rent, current portion | 18 | 41 | ||||||
| Redeemable convertible notes | 5,488 | 19,403 | ||||||
| Total current liabilities | 9,511 | 21,965 | ||||||
| Deferred revenue, noncurrent portion | - | 47 | ||||||
| Deferred rent, noncurrent portion | - | 7 | ||||||
| Total liabilities | 9,511 | 22,019 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value, 5,000,000 shares authorized; 5,500 and 0 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively | - | - | ||||||
| Common stock, $0.001 par value, 100,000,000 shares authorized; 4,310,561 and 801,756 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively | 4 | 1 | ||||||
| Additional paid-in capital | 192,615 | 164,053 | ||||||
| Accumulated other comprehensive income (loss) | 4 | (1 | ) | |||||
| Accumulated deficit | (167,741 | ) | (147,982 | ) | ||||
| Total stockholders' equity | 24,882 | 16,071 | ||||||
| Total liabilities and stockholders' equity | $ | 34,393 | $ | 38,090 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
| Exhibit 99.1 |
| NEWS RELEASE |
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, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Contract revenue | $ | 318 | $ | 109 | $ | 700 | $ | 328 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,805 | 3,396 | 9,286 | 8,443 | ||||||||||||
| General and administrative | 2,391 | 2,425 | 7,407 | 7,083 | ||||||||||||
| Total operating expenses | 6,196 | 5,821 | 16,693 | 15,526 | ||||||||||||
| Loss from operations | (5,878 | ) | (5,712 | ) | (15,993 | ) | (15,198 | ) | ||||||||
| Interest and other income, net | 85 | 941 | 185 | 2,003 | ||||||||||||
| Net loss | (5,793 | ) | (4,771 | ) | (15,808 | ) | (13,195 | ) | ||||||||
| Deemed dividend for convertible preferred stock beneficial conversion feature | - | - | (3,951 | ) | - | |||||||||||
| Net loss attributable to common stockholders | $ | (5,793 | ) | $ | (4,771 | ) | $ | (19,759 | ) | $ | (13,195 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (1.34 | ) | $ | (6.04 | ) | $ | (6.49 | ) | $ | (17.10 | ) | ||||
| Shares used to compute net loss per share attributable to common stockholders, basic and diluted | 4,310,561 | 789,796 | 3,043,919 | 771,713 |
The accompanying notes are an integral part of these condensed consolidated financial statements.