Full Press Release Details
Catalyst Biosciences Announces Change in Corporate Strategy
Reports Third Quarter 2021 Operating & Financial Results
Company to discontinue MarzAA development; focus on developing its complement portfolio
Management to host a call today at 8:30 am ET
SOUTH SAN FRANCISCO, Calif. November 12, 2021 Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced a strategic decision to halt the
clinical development of MarzAA, report data to date, and seek a buyer for its hemophilia assets. Catalyst plans to focus its resources on its complement therapeutics and protease medicines platform. The Company also reported its operating and
financial results for the third quarter ended September 30, 2021.
We have made a strategic decision to stop the clinical development of
MarzAA (engineered FVIIa) and focus solely on our complement programs and protease medicines platform. Based on several factors including a recently updated feasibility assessment, we determined that we cannot continue to develop MarzAA through
completion of the ongoing trials. Enrollment in our MarzAA clinical trials has been adversely impacted by several factors, including pandemic-related logistical challenges, competition for subjects, and increasing availability of prophylaxis therapy
globally. Given these factors, it is no longer feasible for us to deliver topline data in 2022. We will report on the data obtained in the Crimson-1 trial to date showing that we have successfully treated
bleeds with subcutaneous (SQ) MarzAA and have not observed any treatment-related adverse or thrombotic events, said Nassim Usman, Ph.D., chief executive of Catalyst Biosciences.
Dr. Usman continued: We are exploring opportunities to license or sell our MarzAA and DalcA (engineered FIX) portfolios and will donate any standard-of-care to the centers where patients are enrolled. Halting development of MarzAA will allow us to reduce our burn rate by approximately 40% and focus our investment
on our highly promising complement therapeutics and protease medicines platform. We want to thank our study subjects, clinical trial investigators and site staff, employees, and investors for their partnership and commitment to the MarzAA programs
over the last several years.
Candidates from our protease platform offer a differentiated approach to complement regulation by rapidly
engaging and degrading high abundancy targets in a way antibodies and small molecule inhibitors cannot. We believe that investing in novel solutions for complement-mediated disease will open opportunities in multiple settings ranging from
ultra-orphan to large markets with significant unmet needs, including nephrology, inflammation and ophthalmology. We will advance the clinical development of CB 4332, an SQ-dosed enhanced complement Factor I
(CFI), as swiftly as possible and continue to generate development candidates from our protease platform that we will either license out or develop on our own. We believe that the complement therapeutics market holds tremendous potential and that
investing our resources in these programs is the optimal strategy going forward, concluded Dr. Usman.
Complement Program Updates
Third Quarter 2021 Results and Financial Highlights:
management will host a call today, Friday, November 12, 2021 at 8:30 am Eastern Time to discuss the changes to the corporate strategy and answer questions. Shareholders and other interested parties may participate in the conference call by
dialing 877-425-9470 (in the U.S.) or 201-389-0878 (International) and entering passcode
13725012. The call also will be webcast live on the Events and Presentations page of Company s website.
About Catalyst Biosciences, the Protease Medicines company
Catalyst is a research and clinical development biopharmaceutical company focused on developing protease therapeutics to address unmet medical needs in
disorders of the complement system. Proteases are natural regulators of this biological system. We engineer proteases to create improved or novel molecules to treat diseases that result from dysregulation of the complement cascade. Our complement
pipeline consists of a preclinical C3-degrader program licensed to Biogen for dry age-related macular degeneration (dAMD), an improved Complement Factor I protease CB
4332 for SQ replacement therapy in patients with Complement Factor I (CFI) deficiency and proteases from our ProTUNE C3b/C4b degrader and ImmunoTUNE C3a/C5a degrader platforms designed to target specific disorders of the complement or inflammatory pathways.
Forward-Looking Statements
This press release contains
forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include, without limitation, those regarding swiftly moving forward with clinical development of CB 4332, the continued generation of candidates
from the protease platform that will either be licensed or self-developed, reduction of burn rate, the potential that complement will open opportunities in multiple disease settings, submitting an IND for CB 4332, announcing a development candidate
from our ProTUNE platform that leverages our knowledge of CFI, and successfully completing the transfer of CBIO supported activities to Biogen for CB
2782-PEG, as well as statements about the benefits of our protease engineering platform. 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, including, but not limited to, the risk that clinical trials and preclinical studies may be delayed as a result of COVID-19, competitive products, and other factors, that Biogen could terminate our agreement for the development of CB 2782-PEG, that the Company s complement degraders
are not yet in human clinical trials and will require additional manufacturing validation and preclinical testing before entering human clinical trials, that the Company may need to raise additional capital, and other risks described in the
Risk Factors section of the Company s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC ) on March 4, 2021, the Quarterly Report on Form 10-Q to be filed with the SEC on November 12, 2021, and in other filings filed from time to time with the SEC. The Company does not assume any obligation to update any forward-looking statements, except as
Catalyst Biosciences, Inc.
Catalyst Biosciences, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| September 30, 2021 | December 31, 2020 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 59,157 | $ | 30,360 | ||||
| Short-term investments | 5,371 | 48,994 | ||||||
| Accounts receivable | 1,114 | 3,313 | ||||||
| Prepaid and other current assets | 8,322 | 6,843 | ||||||
| Total current assets | 73,964 | 89,510 | ||||||
| Long-term investments | 2,543 | |||||||
| Other assets, noncurrent | 869 | 528 | ||||||
| Right-of-use assets | 2,613 | 1,832 | ||||||
| Property and equipment, net | 1,091 | 433 | ||||||
| Total assets | $ | 78,537 | $ | 94,846 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,862 | $ | 5,931 | ||||
| Accrued compensation | 2,548 | 2,476 | ||||||
| Deferred revenue | 853 | 1,983 | ||||||
| Other accrued liabilities | 8,144 | 6,743 | ||||||
| Operating lease liability | 1,844 | 663 | ||||||
| Total current liabilities | 17,251 | 17,796 | ||||||
| Operating lease liability, noncurrent | 550 | 981 | ||||||
| Total liabilities | 17,801 | 18,777 | ||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.001 par value, 5,000,000 shares authorized; zero shares issued and outstanding | ||||||||
| Common stock, $0.001 par value, 100,000,000 shares authorized; 31,392,618 and 22,097,820 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 31 | 22 | ||||||
| Additional paid-in capital | 443,069 | 390,803 | ||||||
| Accumulated other comprehensive income | 1 | 5 | ||||||
| Accumulated deficit | (382,365 | ) | (314,761 | ) | ||||
| Total stockholders equity | 60,736 | 76,069 | ||||||
| Total liabilities and stockholders equity | $ | 78,537 | $ | 94,846 |
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, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| License | $ | $ | 32 | $ | $ | 15,100 | ||||||||||
| Collaboration | 2,299 | 861 | 4,898 | 3,817 | ||||||||||||
| License and collaboration revenue | 2,299 | 893 | 4,898 | 18,917 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of license | 32 | 3,102 | ||||||||||||||
| Cost of collaboration | 2,307 | 879 | 4,926 | 4,030 | ||||||||||||
| Research and development | 20,352 | 12,249 | 52,754 | 38,419 | ||||||||||||
| General and administrative | 4,869 | 3,833 | 14,799 | 11,895 | ||||||||||||
| Total operating expenses | 27,528 | 16,993 | 72,479 | 57,446 | ||||||||||||
| Loss from operations | (25,229 | ) | (16,100 | ) | (67,581 | ) | (38,529 | ) | ||||||||
| Interest and other income (expense), net | (9 | ) | 67 | (23 | ) | 1,195 | ||||||||||
| Net loss | $ | (25,238 | ) | $ | (16,033 | ) | $ | (67,604 | ) | $ | (37,334 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.80 | ) | $ | (0.73 | ) | $ | (2.23 | ) | $ | (2.05 | ) | ||||
| Shares used to compute net loss per share attributable to common stockholders, basic and diluted | 31,379,755 | 22,072,243 | 30,382,231 | 18,199,575 |