Full Press Release Details
Catalyst Biosciences Reports Second Quarter 2016 Financial Results and Provides Corporate Update
Phase 1 Proof-of-Concept Clinical Trial of High Potency Factor IX Product Subcutaneous
Administration for Hemophilia B to Commence in the First Quarter 2017
Manufacturing Agreement Established for CB 813d, Next-Generation Factor VIIa Product, in
Preparation for a Trial of Subcutaneous Prophylaxis in Hemophilia A and B Inhibitor Patients
SAN FRANCISCO, Calif. August 4, 2016 Catalyst Biosciences, Inc. (Nasdaq: CBIO), a clinical-stage biotechnology company focused on creating and developing novel protease therapeutics to treat serious medical conditions in the
fields of hemostasis and anti-complement, today announced financial results for the second quarter ended June 30, 2016.
quarter, we made progress on our manufacturing preparations for CB 813d, our high potency next-generation Factor VIIa product candidate, signing an agreement with CMC Biologics for cGMP manufacturing, said Nassim Usman, Ph.D., Catalyst s
President and Chief Executive Officer. Early next year, our partner ISU Abxis in South Korea plans to initiate a Phase 1/2 proof of concept subcutaneous trial for CB 2679d (ISU 304) our high potency recombinant Factor IX product candidate for
Hemophilia B. Following completion of the Phase 1/2 trial, Catalyst Biosciences will control the global development of and commercialization rights to CB 2679d outside of South Korea.
Recent Business Highlights
Anticipated Milestones
Financial Results for the Second Quarter Ended June 30, 2016
About Catalyst Biosciences
Catalyst is a clinical-stage biopharmaceutical company focused on creating and developing novel medicines to address serious medical conditions. To date,
Catalyst has focused its product development efforts in the fields of hemostasis, including the treatment of hemophilia and surgical bleeding, and inflammation, including prevention of delayed graft function in renal transplants and the treatment of
dry age-related macular degeneration, a condition that can cause visual impairment or blindness. Catalyst s most
advanced program is an improved next-generation high potency coagulation Factor VIIa variant, CB 813d, that has successfully completed an intravenous Phase 1 clinical trial in severe hemophilia A
and B patients. In addition to Catalyst s lead Factor VIIa program, Catalyst has two other next-generation coagulation factors, a high potency Factor IX variant, CB 2679d/ISU 304, that is in advanced preclinical development and Factor Xa
variants that have demonstrated efficacy in preclinical models. For more information, please visit www.catalystbiosciences.com.
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than
statement of historical facts, included in this press release regarding our strategy, future operations, and plans are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to ISU Abxis
plans with respect to CB/2679d/ISU 304, the ability of CMC to manufacture CB 813d, the potential success of manufacturing technology transfer to CMC, Catalyst s clinical trial timelines for CB 2679/ISU 304 and CB 813d, and the potential uses
and benefits of CB 813d and CB2679d/ISU 304 and Catalyst s other products in development. 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 the technology transfer for manufacturing CB813d may not be
successful, that trials and studies may be 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 described in the Risk Factors section of the Company s
Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC on March 9, 2016 and May 5, 2016, respectively. Catalyst does not assume any obligation to update any forward-looking statements, except as required by law.
Catalyst Biosciences, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| June 30, 2016 | December 31, 2015 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,333 | $ | 29,096 | ||||
| Short-term investments | 12,617 | 3,402 | ||||||
| Restricted cash | 30,395 | 33,794 | ||||||
| Deposits | 5 | 133 | ||||||
| Accounts receivable | 462 | 492 | ||||||
| Prepaid and other current assets | 1,479 | 1,781 | ||||||
| Total current assets | 56,291 | 68,698 | ||||||
| Restricted cash, noncurrent | 125 | 125 | ||||||
| Property and equipment, net | 803 | 698 | ||||||
| Total assets | $ | 57,219 | $ | 69,521 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 826 | $ | 939 | ||||
| Accrued compensation | 682 | 926 | ||||||
| Other accrued liabilities | 456 | 535 | ||||||
| Deposits | 730 | |||||||
| Deferred revenue, current portion | 437 | 438 | ||||||
| Deferred rent, current portion | 30 | 19 | ||||||
| Redeemable convertible notes | 30,344 | 33,743 | ||||||
| Derivative liability | 130 | 1,156 | ||||||
| Total current liabilities | 33,635 | 37,756 | ||||||
| Deferred revenue, noncurrent portion | 73 | 292 | ||||||
| Deferred rent, noncurrent portion | 29 | 48 | ||||||
| Total liabilities | 33,737 | 38,096 | ||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.001 par value, 5,000,000 shares and 0 shares authorized and outstanding at June 30, 2016 and December 31, 2015; | ||||||||
| Common stock, $0.001 par value, 100,000,000 shares authorized at June 30, 2016 and December 31, 2015; 11,503,614 and 11,430,085 shares issued and outstanding at June 30, 2016 and December 31, 2015 | 12 | 11 | ||||||
| Additional paid-in capital | 162,924 | 162,450 | ||||||
| Accumulated other comprehensive income | 7 | 1 | ||||||
| Accumulated deficit | (139,461 | ) | (131,037 | ) | ||||
| Total stockholders equity | 23,482 | 31,425 | ||||||
| Total liabilities and stockholders equity | $ | 57,219 | $ | 69,521 |
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, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Contract revenue | $ | 109 | $ | 859 | $ | 219 | $ | 1,531 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,752 | 1,322 | 5,046 | 2,705 | ||||||||||||
| General and administrative | 2,272 | 1,738 | 4,658 | 4,060 | ||||||||||||
| Total operating expenses | 5,024 | 3,060 | 9,704 | 6,765 | ||||||||||||
| Loss from operations | (4,915 | ) | (2,201 | ) | (9,485 | ) | (5,234 | ) | ||||||||
| Interest and other income, net | 82 | 516 | 1,061 | 691 | ||||||||||||
| Interest Expense | (39 | ) | (39 | ) | ||||||||||||
| Net loss | $ | (4,833 | ) | $ | (1,724 | ) | $ | (8,424 | ) | $ | (4,582 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.42 | ) | $ | (4.60 | ) | $ | (0.74 | ) | $ | (12.26 | ) | ||||
| Shares used to compute net loss per common share, basic and diluted | 11,447,069 | 374,764 | 11,438,588 | 373,633 |