Acer Therapeutics Inc. (ACER) has experienced an increase of 27.31% in the premarket. However, the last trading session closed at $2.49 with a decline of 1.97%.
Second Quarter 2021 Financial Results
ACER reported second-quarter 2021 financial results on 10th August 2021. Firstly, cash and cash equivalents were $22.1 million, up from $5.8 million at the end of 2020. Secondly, research and development costs were $1.5 million, net of $0.9 million in partnership funds, compared to $2.8 million for the same period in 2020. Thirdly, general, and administrative expenditures were $2.3 million, net of $0.5 million in partnership financing, compared to $3.0 million for the same period in 2020. Lastly, the $0.5 million in partnership funds under the Collaboration Agreement with Relief was recognized, resulting in a $0.7 million reduction.
Clinical Trial for EDSIVO
On 10th June 2021, ACER announced that the firm is currently preparing a pivotal clinical study in patients with COL3A1+ vascular Ehlers-Danlos Syndrome. Acer addressed performing a prospective, randomized, double-blind, placebo-controlled, decentralized clinical trial in patients with COL3A1+ vEDS. The company requested the Agency’s judgment on different study design elements.
The FDA recently sent Acer official meeting minutes, which confirm the following points:
- acceptability of a decentralized (virtual) clinical trial design and use of an independent centralized adjudication committee.
- acceptability of a primary endpoint based on clinical events associated with disease outcome; and
- agreement with modest safety data collection.
Collaboration and License Agreement for Worldwide Development and Commercialization of ACER-001
On 22 March 2021, ACER stated that the firms had signed a Collaboration and License Agreement for the development and commercialization of ACER-001 across the world. ACER-001 is a unique sodium phenylbutyrate (NaPB) powder formulation that is both taste-masked and ready to use right away.
Acer will receive an estimated $10 million cash payment from Relief within 15 business days of the CLA’s completion (initially $14 million, to be offset by Relief’s return of the $4.0 million outstanding amount of the preceding loan, plus interest). For the UCDs and MSUD indications, Relief will pay Acer up to $20 million in development and commercial launch expenditures in the United States. In the United States, Canada, Brazil, Turkey, and Japan, Acer will maintain development and commercialization rights.
Fourth Quarter & Full Year 2020 Financial Results by ACER
ACER reported fourth-quarter and full-year 2020 financial results on March 1, 2021. Firstly, cash and cash equivalents were $5.8 million, down from $12.1 million the previous year. Secondly, the company believes that its cash and cash equivalents will enable it to meet its financial obligations. Thirdly, research and development costs were $3.5 million, compared to $2.8 million for the same period last year. Lastly, general and administrative costs were $11.0 million, compared to $16.0 million for the year ended December 31, 2019.
