HSTO

Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company on developing potential first-in-class clinical and preclinical small molecule pan-caspase and caspase selective inhibitors that protect the body’s natural process to restore immune function, today announced that the US Patent and Trademark Office (USPTO) has issued US Patent No. 11,579,703 titled “Caspase Inhibitors and Methods of Use Thereof.”

We believe this key patent provides broad coverage for Histogen’s portfolio of highly selective and orally active anti-inflammatory caspase inhibitors, including CTS-2090. This patent includes information that CTS-2090 has demonstrated potent oral activity in a well characterized model of ulcerative colitis. Importantly, CTS-2090 provided statistically significant protection against inflammation-driven damage to the lining of the GI tract and also protected against loss of body weight. While CTS-2090 is a potent inflammatory, it had no effect in well-accepted cellular and in vivo models of apoptosis, confirming its high selectivity as an anti-inflammatory caspase inhibitor.

“We are pleased that this important patent has issued. It builds upon Histogen’s growing proprietary caspase inhibitor portfolio that includes the US patent No. 11,447,497 issued in September of 2022. This previously issued patent discloses a broad class of novel pan-caspase inhibitors with unique chemical properties,” stated Alfred Spada, EVP and Chief Scientific Officer of Histogen. “In addition to these two important patents to support our expanding pipeline, we are also evaluating the potential use of our clinical stage pan-caspase inhibitor, emricasan, in acute bacterial skin infections, including those related to methicillin resistant staph aureus (MRSA).”

About Histogen Inc.

Histogen Inc. is a clinical-stage therapeutics company focused on developing potential first-in-class clinical and preclinical small molecule pan-caspase and caspase selective inhibitors that protect the body’s natural process to restore immune function. Currently, we are developing emricasan for acute bacterial skin and skin structure infections (ABSSSI) as well evaluating its use for other infectious diseases. Our pipeline also includes novel preclinical product candidates including CTS-2090 and other proprietary caspase inhibitors, which are selective small molecule inhibitors of caspase-1 designed for the treatment of certain inflammatory diseases. For more information, please visit www.histogen.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss our future operations and our ability to successfully initiate, enroll and complete clinical trials, obtain clinical trial data, and achieve regulatory milestones and related timing, including those related to the timing of providing clinical development guidance on the development of emricasan and any further evaluation of CTS-2090 and other proprietary caspase inhibitors. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Histogen that could differ materially from those described in or implied by the statements in this press release, including: our ability to obtain funding for our operations, including funding necessary to complete further development and any commercialization of our product candidates; our ability to carry out the development of CTS-2090 or emricasan and the potential for delays in the timing of regulatory approval and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; our expectations regarding the operation of our product candidates and related benefits and patent coverage; our beliefs regarding the success, cost and timing of our product candidate development and current and future clinical trials and studies; our beliefs regarding the potential markets for our product candidates;  any impact of the COVID-19 pandemic, or responses to the pandemic, on our business, clinical trials or personnel;  our beliefs regarding our industry;  our ability to attract and retain key personnel; regulatory developments in the United States and foreign countries, with respect to our product candidates; the impact of any litigation proceedings on our business and market and other conditions. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in our filings with the Securities and Exchange Commission. Except as otherwise required by law, Histogen disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.

CONTACT:

Susan A. KnudsonExecutive Vice President, COO & CFO Histogen Inc. ir@histogen.com