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
“2019 will be a very exciting year for Catalyst with several clinical and regulatory read outs expected throughout the year,” said
- Marzeptacog alfa (activated) – MarzAA, subcutaneously administered next-generation engineered coagulation Factor VIIa: Completed enrollment of 11 individuals, with hemophilia and an inhibitor in a Phase 2 efficacy trial. The trial is evaluating the ability of MarzAA to eliminate, or minimize, spontaneous bleeding episodes in individuals with hemophilia A or B with an inhibitor. As of
February 2019, seven of 11 subjects had completed dosing with a reduction in annual bleed rates (ABR) from 18.2 to 2.1 (>90% reduction) and five of the seven had no bleeds for 50 days at their final dose. The Company’s interim data indicates MarzAA is safe and well tolerated. Subcutaneous half-life increased to 13.1 hours compared with intravenous half-life of 3.9 hours.
- Dalcinonacog alfa – DalcA, subcutaneously administered next-generation engineered coagulation Factor IX: Completed a Phase 1/2 subcutaneous dosing trial. The trial evaluated the safety and efficacy of DalcA in individuals with severe hemophilia B. Data from the study demonstrated that DalcA is highly efficacious, achieving activity levels well above that required for prevention of spontaneous bleeding. Two subjects developed neutralizing antibodies, one transiently, that did not interfere with their ability for continued use of other FIX products. The Company completed a full investigation and concluded that DalcA has a similar low immunogenicity potential as do BeneFIX and other commercial wildtype Factor IX products. The Company is moving forward in clinical development of DalcA and will start a Phase 2b trial in
March 2019, enrolling up to six patients each with 28 days of dosing.
- DalcA: Amended the
ISU Abxislicense and collaboration agreement to replace the original profit-sharing arrangement with a low single-digit royalty, on a country-by-country basis, for net product sales of DalcA by the Company or its affiliates in each country other than South Korea.
- CB 2679d-GT – Factor IX Gene Therapy: Demonstrated 3-fold superior clotting activity and a 4 to 5-fold reduction in bleeding time in a hemophilia B mouse model of AAV gene therapy delivery containing the DalcA sequence compared with a gene therapy construct containing the Padua variant, that is the current lead clinical variant in development.
- Financial: Strong cash and short-term investments balance of
$120.1 million, which positions the Company to fund the clinical development of the MarzAA and DalcA programs.
- Complete the MarzAA Phase 2 open-label subcutaneous efficacy trial with topline data read out in Q3 2019 and final data read out in Q4 2019; initiate a MarzAA Phase 1 PK/PD study in Q2 2019 with final data read out in Q4 2019; initiate an End of Phase 2 meeting with the
FDAin Q4 2019
- Initiate a DalcA Phase 2b study in Q1 2019 with topline data readout in Q3 2019 and final data readout in Q4 2019
- Demonstrate prolonged PK/PD for the anti-C3 protease in the dAMD program in Q2 2019
Fourth Quarter and Full-year 2018 Results and Financial Highlights
- Cash, cash equivalents and short-term investments, as of
December 31, 2018were $120.1 milliondue primarily to the approximately $106.8 millionin net financing in February 2018and $9.5 millionin proceeds from the exercise of warrants during the first quarter 2018.
- Research and development expense for the three-months and full-year ended
December 31, 2018was $8.2 millionand $21.5 million, respectively, compared with $3.6 millionand $12.8 millionfor the prior year periods, respectively. The increase was due primarily to investments in the development of the MarzAA and DalcA clinical programs.
- General and administrative expense for the three-months and year-ended
December 31, 2018was $3.4 millionand $12.4 million, respectively, compared with $2.6 millionand $10.0 millionfor the prior year periods, respectively. The increase was due primarily to increases in personnel and non-cash stock-based compensation expense.
- Interest and other income for the three-months and the year ended
December 31, 2018was $0.8 millionand $3.8 million, respectively, compared with $0.1 millionand $0.3 millionfor the prior year periods, respectively. Interest income increased by $2.0 millionin 2018 due to the higher cash balances from the financing and the exercise of warrants. The Company also received a $1.5 millionmilestone payment under an asset sale agreement in 2018.
- Net loss attributable to common stockholders for the three-months and year-ended
December 31, 2018was $10.9 million, or ($0.91)per basic and diluted share, and $30.1 million, or ($2.68)per basic and diluted share, respectively, compared with $5.8 million, or ($1.26)per basic and diluted share, and $25.5 million, or ($7.45)per basic and diluted share, for the prior year periods, respectively.
February 19, 2018, the final $5.1 millionof the Company’s redeemable convertible notes matured and were repaid in full.
- As of
December 31, 2018, the Company had 11,954,528 shares of common stock outstanding.
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address serious medical conditions for individuals who need new or better treatment options. We are focusing our product development efforts in the field of hemostasis (the process that regulates bleeding) and have a mission to develop valuable therapies for individuals with hemophilia. For more information, please visit www.catalystbiosciences.com.
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements about the potential commercial market for DalcA and MarzAA, the relative safety of DalcA compared with BeneFIX and other recombinant Factor IX products, Catalyst’s plans to commence a Phase 2b clinical trial of DalcA in
LifeSci Public Relations
|Catalyst Biosciences, Inc.|
|Consolidated Balance Sheets|
|(In thousands, except shares and per share amounts)|
|December 31, 2018||December 31, 2017|
|Cash and cash equivalents||$||31,213||$||14,472|
|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|
|Liabilities and stockholders’ equity|
|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||—|
|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, $0.001 par value, 100,000,000 shares authorized; 11,954,528 and 6,081,230 shares issued and outstanding at December 31, 2018 and 2017, respectively||12||6|
|Additional paid-in capital||323,279||204,262|
|Accumulated other comprehensive loss||(4||)||—|
|Total stockholders’ equity||119,945||30,774|
|Total liabilities and stockholders’ equity||$||124,920||$||39,513|
|Catalyst Biosciences, Inc.|
|Consolidated Statements of Operations|
|(In thousands, except shares and per share amounts)|
|Year Ended December 31,|
|Research and development||21,474||12,847|
|General and administrative||12,354||9,993|
|Total operating expenses||33,828||22,840|
|Loss from operations||(33,822||)||(21,822||)|
|Interest and other income, net||3,767||261|
|Deemed dividend for convertible preferred stock beneficial conversion feature||-||(3,951||)|
|Net loss attributable to common stockholders||$||(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|
Source: Catalyst Biosciences, Inc.