On May 15, 2023 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing innovative therapies for liver and other chronic diseases, reported corporate updates and financial results for the first quarter ended March 31, 2023 (Press release, CymaBay Therapeutics, MAY 15, 2023, View Source [SID1234631712]).
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Sujal Shah, President and CEO of CymaBay, stated, "In a year with RESPONSE pivotal phase 3 data fast approaching, we have already achieved a number of key goals thus far in 2023. In January, we licensed rights to Kaken Pharmaceutical Company to develop and commercialize seladelpar for patients with PBC in Japan and strengthened our balance sheet with a successful financing. In April, we announced that the ENHANCE phase 3 trial results were published in Hepatology, a preeminent medical journal in the field of liver disease. Last week, we announced the appointment of Harish Shantharam as Chief Financial Officer. These accomplishments set up the remainder of 2023 as we look to share data from RESPONSE, manufacture commercial supplies of seladelpar, prepare regulatory filings and advance our pre-commercial planning. We look forward to sharing updates across all of these activities through the remainder of the year."
Corporate Updates:
Appointed Harish Shantharam to the role of Chief Financial Officer in May 2023. Harish brings nearly 20 years of experience leading financial functions in biotech with a strong emphasis on setting strategy and building financial planning and accounting operations to prepare companies for commercial drug launch.
ENHANCE manuscript titled "Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study" published in April 2023 in Hepatology, a preeminent journal in the field of liver disease.
Entered into a collaboration and license agreement with Kaken Pharmaceutical Co., Ltd. in January 2023 for the development and commercialization in Japan of CymaBay’s investigational drug seladelpar for the treatment of PBC.
Financial Updates:
Completed a public equity offering in January 2023, in which we sold 11,821,428 shares of common stock at $7.00 per share and pre-funded warrants to purchase 2,142,857 shares of common stock at $6.9999 per share. Net proceeds of the offering were $92.4 million after deducting underwriting commissions and other offering expenses.
Held $236.4 million in cash, cash equivalents and investments as of March 31, 2023. We believe that cash and investments on hand are sufficient to fund CymaBay’s operating plan through the third quarter of 2024.
First Quarter Ended March 31, 2023 Financial Results
Research and development expenses for the three months ended March 31, 2023, and 2022 were $18.6 million and $18.4 million, respectively. Research and development expenses for the three months ended March 31, 2023 had a moderate increase compared to the corresponding period in 2022 primarily due to lower project costs spending on completion of enrollment of our RESPONSE trial and in drug manufacturing and development for PBC offset by higher employee compensation as we continued to hire additional personnel to support our clinical studies.
General and administrative expenses for the three months ended March 31, 2023 and 2022 were $8.3 million and $6.1 million, respectively. General and administrative expenses for the three months ended March 31, 2023 were higher than the corresponding period in 2022 as we continued to add administrative personnel and expand our infrastructure to support our corporate growth.
Net loss for the three months ended March 31, 2023 and 2022 was $28.8 million and $27.8 million, or ($0.29) and ($0.32) per share, respectively. Net loss for the three months ended March 31, 2023 was higher than the corresponding period in 2022 due primarily to an increase in general and administrative expenses, partially offset by higher interest income earned on our investments. Overall, we expect operating expenses to increase in the future as we continue to execute our development and pre-commercialization plans for seladelpar in PBC.