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Organization and Operations
12 Months Ended
Dec. 31, 2019
Organization and Operations  
Organization and Operations

1.    Organization and Operations

 

The Company

 

Catabasis Pharmaceuticals, Inc. (the "Company") is a clinical-stage biopharmaceutical company.  The Company’s lead program is edasalonexent, an oral small molecule designed to inhibit NF-B, or nuclear factor kappa-light-chain-enhancer of activated B cells, in development for the treatment of Duchenne muscular dystrophy (“DMD”). The Company believes edasalonexent has the potential to be a foundational therapy for all patients affected by DMD, regardless of the underlying dystrophin mutation. DMD is an ultimately fatal genetic disorder involving progressive muscle degeneration. The United States Food and Drug Administration has granted orphan drug, fast track and rare pediatric disease designations to edasalonexent for the treatment of DMD.  The European Commission has granted orphan medicinal product designation to edasalonexent for the treatment of DMD. The Company was incorporated in the State of Delaware on June 26, 2008.

 

Liquidity

 

The Company has entered into various sales agreements with Cowen and Company LLC, (“Cowen”), pursuant to which the Company could issue and sell shares of common stock under at-the-market offering programs (the “ATM Programs”). Shares sold pursuant to these sales agreements were sold pursuant to shelf registration statements, one of which became effective on July 19, 2016 and which was replaced by a new shelf registration statement, which became effective May 22, 2019. The Company pays Cowen 3% of the gross proceeds from any common stock sold through these sales agreements. The Company currently has $43.6 million remaining available under its sales agreement.

 

During the year ended December 31, 2019, the Company sold an aggregate of 1,282,904 shares of common stock pursuant to the ATM Programs, at an average price of $5.81 per share, for gross proceeds of $7.5 million, resulting in net proceeds of $7.0 million after deducting sales commissions and offering expenses.

 

On February 6, 2019, the Company entered into an underwriting agreement with Oppenheimer & Co. Inc. relating to an underwritten public offering (the “February 2019 Financing”) of 4,000,000 shares of common stock and accompanying warrants to purchase up to 2,000,000 shares of common stock, at a combined price to the public of $5.00 per unit, for net proceeds of $18.5 million.

 

On June 19, 2018, the Company entered into an underwriting agreement with Oppenheimer & Co. Inc. relating to an underwritten public offering (the “June 2018 Financing”) of 4,200,000 shares of the Company’s common stock, par value $0.001 per share, and accompanying warrants to purchase up to 4,200,000 shares of common stock, at a combined price to the public of $10.00 per unit, for gross proceeds of $42.0 million, and net proceeds of $38.9 million.

 

As of December 31, 2019, the Company had an accumulated deficit of $223.6 million. The Company has been primarily involved with research and development activities and has incurred operating losses and negative cash flows from operations since its inception.

 

The Company is subject to a number of risks similar to other life science companies, including, but not limited to, successful discovery and development of its drug candidates, raising additional capital, development by its competitors of new technological innovations, protection of proprietary technology and regulatory approval and market acceptance of the Company’s products. The Company anticipates that it will continue to incur significant operating losses for the next several years as it continues to develop its product candidates.

 

As of December 31, 2019, the Company had available cash, cash equivalents and short-term investments of $36.2 million. Subsequent to December 31, 2019, the Company raised net proceeds of $25.6 million through 2020 equity financings. Based on the Company’s current operating plan, the Company believes it has sufficient cash, cash equivalents and short-term investments to fund operations for at least 12 months following the issuance of these consolidated financial statements.

 

The Company will require substantial additional capital to fund operations. The Company has not generated any product revenues and has financed its operations primarily through public offerings and private placements of its equity securities. There can be no assurance that the Company will be able to obtain additional debt or equity financing or generate product revenue or revenues from collaborative partners, on terms acceptable to the Company, on a timely basis or at all. The failure of the Company to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on the Company’s business, results of operations, and financial condition.