Catalyst Biosciences Reports Second Quarter 2021 Operating & Financial Results and Provides a Corporate Update
"We continue to make progress in our complement and hemostasis programs. In complement, we are advancing the development of our SQ enhanced CFI development candidate, CB 4332, where we screened the first patient in our natural history study for CFI deficiency (“ConFIrm”). We also recently disclosed new proteases from our ProTUNE™; C3b-C4b degrader and ImmunoTUNE™; C3a-C5a degrader platforms designed to target specific disorders of the complement or inflammatory pathways,” said
Marzeptacog alfa (activated) – MarzAA
Food and Drug Administration(FDA) has granted Fast Track Designation for MarzAA for treatment of episodic bleeding in subjects with Factor FVII deficiency in June 2021. The FDA granted the Fast Track Designation for the treatment of episodic bleeding in subjects with Hemophilia A or B with inhibitors in December 2020.
- Presented four posters at the
International Society for Thrombosis and Haemostasis(ISTH) 2021 Virtual Congressin July 2021. The data presented support the Company’s ongoing trials of MarzAA in hemostasis.
Systemic Complement Program
- Launched the ConFIrm study with the screening of the first patient in its CFI-deficiency study in the CB 4332 program, Catalyst’s wholly-owned, first-in-class, enhanced Complement Factor I (CFI), intended for prophylactic subcutaneous (SQ) administration in individuals with CFI deficiency. The ConFIrm screening study will measure CFI levels and activity in patients who have diseases related to a CFI deficiency and who may potentially benefit from CB 4332 treatment.
- Hosted a research and development day on its protease medicines platform focusing on the regulation of complement, including CB 4332. The event featured a presentation by Filomeen Haerynck, M.D., Ph.D., University of Ghent, Belgium, who discussed the clinical phenotype, current treatment landscape and unmet medical need in treating patients with complement factor I (CFI) deficiency and other complement system disorders. Members of the Catalyst management team also discussed the proteases from the Company’s degrader platforms, designed to target specific disorders of the complement and other inflammatory pathways as well as other complement programs in development.
- Catalyst announced that it has promoted Grant Blouse, Ph.D., to chief scientific officer and Tom Knudsen, DVM, Ph.D., to senior vice president, corporate development.
Howard Levy, M.B.B.Ch, Ph.D., M.M.M., chief medical officer, announced his plan to retire and transition to a senior clinical advisor role to Catalyst.
Systemic Complement Program
- Advance CB 2782-PEG, the C3 degrader for the potential treatment of dry AMD in collaboration with Biogen towards the clinic
- Provide additional preclinical data supporting continued development of the C4b degrader program and other complement assets
- Submit an IND and initiate global clinical trial of CB 4332
- Announce development candidates in lead discovery programs
- Present PK and biomarker data for CB 4332
- Continue enrolling the Crimson 1 Phase 3 registrational and the Phase 1/2 trials
- Submit the first Crimson 1 report to the Data and Safety Monitoring Board (DSMB)
- Present PK data from the Phase 1/2 trial
Second Quarter 2021 Results and Financial Highlights
- Cash, cash equivalents and short-term investments, as of June 30, 2021 were $86.5 million.
- Research and development expenses were
$15.4 millionand $12.9 millionduring the three months ended June 30, 2021and 2020, respectively, an increase of $2.5 million, or 19%. The increase was due primarily to an increase of $1.4 millionin personnel and facilities costs and an increase of $1.5 millionin clinical and manufacturing costs, partially offset by a decrease of $0.4 millionin preclinical spending.
- General and administrative expenses were
$4.5 millionand $4.4 millionduring the three months ended June 30, 2021and 2020, respectively, an increase of $0.1 million, or 3%. This increase was due primarily to an increase of $0.3in personnel-related costs, partially offset by $0.2 millionin facilities and overhead costs.
- Interest and other income (expense), net was
$0.0 millionand $0.1 millionduring the three months ended June 30, 2021and 2020, respectively, a decrease of $0.1 million. The decrease was primarily due to a decrease in interest income on investments.
- Net loss attributable to common stockholders for the three-months ended June 30, 2021 was $19.9 million, or (
$0.64) per basic and diluted share, compared with $17.2 million, or ( $0.96) per basic and diluted share, for the prior year period.
- As of June 30, 2021, the Company had 31,349,740 shares of common stock outstanding.
Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a preclinical C3-degrader program licensed to Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with 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 as well as other complement programs in development.
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include, without limitation, statements about the product candidates of
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 trials and studies may be delayed as a result of COVID-19, competitive products and other factors, that trials may not have satisfactory outcomes, the risk that the ConFIrm and ConFIdence trials will not validate the potential market for CB 4332; the risk Catalyst may elect to terminate or postpone ongoing development programs, including development of MarzAA or any of the Company’s complement assets; the risk that the Company will need to raise additional capital, which may not be available on faorable terms if at all; the risk that Biogen will terminate Catalyst's agreement, and other risks described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 6, 2021, and in 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.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
|Cash and cash equivalents||$||73,621||$||30,360|
|Prepaid and other current assets||8,332||6,843|
|Total current assets||96,826||89,510|
|Other assets, noncurrent||1,169||528|
|Property and equipment, net||684||433|
|Liabilities and stockholders’ equity|
|Other accrued liabilities||7,366||6,743|
|Operating lease liability||1,814||663|
|Total current liabilities||15,568||17,796|
|Operating lease liability, noncurrent||1,054||981|
22,097,820 shares issued and outstanding at
|Additional paid-in capital||442,258||390,803|
|Accumulated other comprehensive income||2||5|
|Total stockholders’ equity||85,164||76,069|
|Total liabilities and stockholders’ equity||$||101,786||$||94,846|
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
|Three Months Ended
||Six Months Ended
|License and collaboration revenue||1,132||1,658||2,599||18,024|
|Cost of license||—||23||—||3,070|
|Cost of collaboration||1,139||1,719||2,619||3,151|
|Research and development||15,389||12,906||32,402||26,170|
|General and administrative||4,518||4,371||9,930||8,062|
|Total operating expenses||21,046||19,019||44,951||40,453|
|Loss from operations||(19,914||)||(17,361||)||(42,352||)||(22,429||)|
|Interest and other income (expense), net||(14||)||113||(14||)||1,128|
|Net loss per share attributable to common
stockholders, basic and diluted
|Shares used to compute net loss per share attributable to
common stockholders, basic and diluted
Source: Catalyst Biosciences, Inc.