Catabasis Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Provides a Corporate Update
-- Recently Completed Acquisition of Quellis Biosciences Includes QLS-215, a Potential Best-in-Class Monoclonal Antibody Inhibitor of Plasma Kallikrein in Preclinical Development for the Treatment of Hereditary Angioedema --
-- Proceeds from
“With our acquisition of Quellis and concurrent financing, we believe Catabasis is well positioned to advance the development of our lead program, QLS-215, as a differentiated and potential best-in-class new therapy for the chronic treatment of patients affected by hereditary angioedema to prevent attacks,” said
QLS-215 for the Treatment of Hereditary Angioedema (HAE)
- The vision for the lead program, QLS-215, is to develop the best-in-class monoclonal antibody inhibitor of plasma kallikrein for HAE with infrequent dosing and sustained inhibitory blood levels. HAE is a rare, debilitating and potentially life-threatening disease in which plasma kallikrein is a critical component that triggers a cascade of pathologic vascular permeability, vasodilation and ultimately excessive tissue swelling.
- QLS-215 is a humanized monoclonal antibody targeting plasma kallikrein that has demonstrated potent inhibition of plasma kallikrein as well as an extended plasma half-life in non-human primates.
-
Catabasis expects to file an Investigational New Drug application for QLS-215 in the first half of 2022 and plans to initiate a Phase 1a clinical trial with initial results anticipated by the end of 2022. Subsequently, Catabasis expects to initiate a Phase 1b/2 trial in patients affected by
HAE in 2023 with initial results anticipated by the end of 2023.
Acquisition of Quellis Biosciences
-
In
January 2021 , Catabasis acquiredQuellis Biosciences Inc. in a stock-for-stock transaction whereby all outstanding equity interests of Quellis were exchanged in a merger for a combination of shares of Catabasis common stock and shares of Series X Preferred Stock.
Private Placement Financing
-
Concurrent with the acquisition of Quellis, Catabasis entered into definitive agreements for a private placement with institutional accredited investors to raise approximately
$110 million before deducting placement agent and other offering expenses, through the issuance of shares of Series X Preferred Stock. The private placement closed onFebruary 1, 2021 . -
The financing was led by
Perceptive Advisors , with participation fromFairmount Funds Management LLC ,RA Capital Management , Cormorant Asset Management,Venrock Healthcare Capital Partners ,Logos Capital ,Boxer Capital , Acorn Bioventures,Commodore Capital ,Surveyor Capital (aCitadel company),Acuta Capital Partners ,Sphera Healthcare , andSerrado Capital LLC .
Capital Structure
-
After the acquisition of Quellis and the private placement, Catabasis had approximately 23.4 million shares of common stock and approximately 86,000 shares of non-voting Series X Preferred Stock outstanding. Subject to stockholder approval, each share of Series X Preferred Stock is convertible into 1,000 shares of Catabasis common stock. If such conversion is approved by our stockholders, each share of Series X Preferred Stock will automatically convert into 1,000 shares of Catabasis common stock, subject to certain beneficial ownership limitations set by each holder not to exceed 19.99%. On a post-conversion basis, common shares outstanding will be approximately 109.5 million. Catabasis expects to seek stockholder approval at its 2021 Annual Meeting of Stockholders, which Catabasis has scheduled for
June 2, 2021 .
Fourth Quarter and Full Year 2020 Financial Results
Cash Position: As of
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Operating Loss: Loss from operations was
Net Loss: Net loss was
About Catabasis
At
Forward Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: the Company’s projected cash runway; expectations regarding the timing for the filing of an IND and commencement and completion of clinical trials for QLS-215; the potential attributes of QLS-215; future product development plans; and stockholder approval of the conversion rights of the Series X preferred stock. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future conditions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties: related to the Company’s ability to recognize the anticipated benefits of the Quellis acquisition; the outcome of any legal proceedings that may be instituted against the Company or Quellis following the announcement of the Quellis acquisition and related transactions; costs related to the Quellis acquisition; changes in applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors, including the COVID-19 pandemic; risks inherent in pharmaceutical research and development, such as: adverse results in our drug discovery, preclinical and clinical development activities, the risk that the results of pre-clinical studies may not be replicated in clinical studies, our ability to enroll patients in our clinical trials, and the risk that any of our clinical trials may not commence, continue or be completed on time, or at all; decisions made by the
Consolidated Statements of Operations (In thousands, except share and per share data) (Audited) |
||||||||
Year Ended |
||||||||
2020 |
2019 |
|||||||
Operating expenses: | ||||||||
Research and development |
$ |
25,590 |
|
$ |
18,317 |
|
||
General and administrative |
|
11,845 |
|
|
8,771 |
|
||
Total operating expenses |
|
37,435 |
|
|
27,088 |
|
||
Loss from operations |
|
(37,435 |
) |
|
(27,088 |
) |
||
Other income (expense): | ||||||||
Interest and investment income |
|
236 |
|
|
845 |
|
||
Other expense, net |
|
(101 |
) |
|
(50 |
) |
||
Total other income, net |
|
135 |
|
|
795 |
|
||
Net loss |
$ |
(37,300 |
) |
$ |
(26,293 |
) |
||
Net loss per share - basic and diluted |
$ |
(2.03 |
) |
$ |
(2.35 |
) |
||
Weighted-average common shares outstanding used in net loss per share - basic and diluted |
|
18,351,470 |
|
|
11,199,057 |
|
Selected Consolidated Balance Sheets Data (In thousands) (Audited) |
||||||
2020 |
2019 |
|||||
Assets | ||||||
Cash and cash equivalents |
$ |
24,930 |
$ |
9,899 |
||
Short-term investments |
|
20,000 |
|
26,345 |
||
Right-of-use asset |
|
966 |
|
2,349 |
||
Other current and long-term assets |
|
1,560 |
|
3,187 |
||
Total assets |
|
47,456 |
|
41,780 |
||
Liabilities and stockholders’ equity | ||||||
Current portion of operating lease liabilities |
|
649 |
|
1,225 |
||
Long-term portion of operating lease liabilities |
|
397 |
|
1,028 |
||
Other current and long-term liabilities |
|
5,741 |
|
3,807 |
||
Total liabilities |
|
6,787 |
|
6,060 |
||
Total stockholders’ equity |
$ |
40,669 |
$ |
35,720 |
Selected Consolidated Statements of Cash Flows Data (In thousands) (Audited) |
||||
Year Ended |
||||
2020 |
2019 |
|||
Net cash used in operating activities |
|
|
||
Net cash provided by (used in) investing activities |
6,300 |
(4,082) |
||
Net cash provided by financing activities |
40,860 |
25,620 |
||
Net increase (decrease) in cash, cash equivalents and restricted cash |
|
|
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Catabasis Contacts:
Investor relations:
investors@catabasis.com
Media:
media@catabasis.com
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