ACER Stock Price Increases Over 100% Pre-Market: What You Should Know About The Company

By Amit Chowdhry ● March 15, 2021
  • The stock price of Acer Therapeutics Inc (NASDAQ: ACER) has increased by over 100% pre-market as of 6:00 AM ET. This is what you should know about the company.

The stock price of Acer Therapeutics Inc (NASDAQ: ACER) – a pharmaceutical company, focuses on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases – has increased by over 100% pre-market as of 6:00 AM ET. This is what you should know about the company. 

There are rumors about the company that it could potentially be merging with Relief Therapeutics. Relief Therapeutics recently announced it entered into a definitive agreement with a single healthcare-dedicated U.S. institutional investor to purchase in a private placement 41,459,370 of Relief common stock at a purchase price of CHF 0.2412 per share. The aggregate gross proceeds from the private placement are expected to be about CHF 10 million, before deducting the placement agent fees and offering expenses payable by Relief. 

On March 1, Acer Therapeutics had reported its results for the fourth quarter and full year ended December 31, 2020.

Q4 2020 And Recent Highlights

ACER-001
– Signed an Option Agreement with Relief Therapeutics Holding AG on January 25, 2021, providing Relief with exclusivity until June 30, 2021, for the right to pursue a potential collaboration and license agreement for worldwide development and commercialization for ACER-001. And in return, Acer received a $1 million upfront nonrefundable payment and a $4 million secured loan from Relief

– Announced in February 2021 topline results from Acer’s bioequivalence trial in which ACER-001 showed similar relative bioavailability compared to BUPHENYL® (sodium phenylbutyrate) under fed conditions
EDSIVO (celiprolol) 

– Announced in December 2020 publication by Swedish investigators of additional long-term data from COL3A1-positive vascular Ehlers-Danlos Syndrome (vEDS) patients in the European Journal of Vascular and Endovascular Surgery entitled “Celiprolol Treatment in Patients with Vascular Ehlers-Danlos Syndrome”

​- Submitted a Type B meeting request to the FDA in February 2021 to discuss Acer’s proposed plan to collect additional data and provide confirmatory evidence in support of celiprolol’s potential benefit in treating COL3A1-positive vEDS patients

ACER-801 (osanetant) 

– Completed active pharmaceutical ingredient (API) manufacturing and advanced other development activities to support an Investigational New Drug Application (IND) submission

Corporate 

– Promoted Jefferson Davis to Chief Business Officer in February 2021. A veteran life science executive and transaction specialist with over 25 years of experience in business and corporate development, Mr. Davis has led or supported over 40 transactions with an aggregate value of more than $2 billion across all major therapeutic platforms, including antibodies, small molecules, aptamers, gene therapy, vaccines, and proteins

​- Ended the fourth quarter with $5.8 million in cash and cash equivalents. Acer believes its cash position as of December 31, 2020, combined with an additional $3.2 million of net proceeds subsequently received from the sales of common stock under its ATM facility and through its equity line purchase agreement with Lincoln Park Capital, along with the $1.0 million nonrefundable payment and $4.0 million secured loan received from Relief Therapeutics following the signing of the ACER-001 Option Agreement, will be sufficient to fund its operations into the third quarter of 2021

Upcoming Milestones

ACER-001

Q2 2021: Targeting a pre-New Drug Application (NDA) meeting with the FDA in the second quarter of 2021, assuming successful completion of the ongoing development activities

​Mid-2021: ACER-001 NDA submission for treatment of patients with Urea Cycle Disorders (UCDs) is anticipated in mid-2021, provided that no additional data is requested by the FDA during Acer’s pre-NDA meeting and ongoing development activities are successfully completed (including evaluation of long-term product stability data)
EDSIVO

Q2 2021: Obtain FDA feedback from a Type B meeting in the second quarter of 2021 regarding Acer’s proposed plan to collect additional data – which if discussions are successful and the collected data is sufficient could potentially satisfy the substantial evidence of effectiveness needed to support a resubmission of the EDSIVO NDA (although neither EDSIVO NDA resubmission nor approval is assured) 

ACER-801 (osanetant) 

Q3 2021: IND submission for osanetant is anticipated in the third quarter of 2021

​Q4 2021: Initiation of a Phase 2 clinical trial of osanetant in BRCA-positive patients who have undergone a prophylactic bilateral salpingo-oophorectomy (PBSO) is expected in the fourth quarter of 2021, dependent upon successful IND filing and subject to additional capital
ACER-2820 (emetine) 

Ongoing: Further advancement of the emetine program for infectious diseases, including COVID-19, is dependent on Acer’s ability to raise non-dilutive capital

​Ongoing: The Company believes that most of the emetine IND-enabling work is in progress or complete, and intends to minimize future emetine spending as it continues to work with federal agencies and private research organizations toward the goal of securing non-dilutive funding

Financial Results Q4 and Full Year 2020

Cash position

Cash and cash equivalents were $5.8 million as of December 31, 2020, compared to $12.1 million as of December 31, 2019. Acer believes its cash and cash equivalents available as of December 31, 2020, combined with an additional $3.2 million of net proceeds subsequently received from the sales of common stock under its ATM facility and through its equity line purchase agreement with Lincoln Park Capital, along with the $1.0 million nonrefundable payment and $4.0 million secured loan received from Relief Therapeutics following the signing of the ACER-001 Option Agreement, will be sufficient to fund its operations into the third quarter of 2021.

Research and Development Expenses

Research and development expenses were $3.5 million for the three months ended December 31, 2020, compared to $2.8 million for the three months ended December 31, 2019. Research and development expenses for the three months ended December 31, 2020 were comprised of $1.3 million related to ACER-001, $1.5 million related to emetine, $0.6 million related to osanetant, and $0.1 million related to EDSIVO™. Research and development expenses were $11.8 million for the year ended December 31, 2020, compared to $13.9 million for the year ended December 31, 2019. This decrease of approximately $2.1 million was primarily due to decreases in employee-related expense and in spending related to clinical and other consulting services, partially offset by an increase in contract research expenses.

General and Administrative Expenses

General and administrative expenses were $2.7 million for the three months ended December 31, 2020, compared to $2.4 million for the three months ended December 31, 2019. General and administrative expenses were $11.0 million for the year ended December 31, 2020, compared to $16.0 million for the year ended December 31, 2019. This decrease of $5.0 million was primarily due to decreases in employee-related expenses and precommercial activities expenses, partially offset by an increase in legal expenses. This decrease in employee-related expenses resulted from a decrease in headcount as a consequence of the restructuring initiative undertaken after receipt of the Complete Response Letter from the FDA for EDSIVO™ in June 2019.

Net Loss

Net loss for the three months ended December 31, 2020 was $6.2 million, or $0.50 net loss per share (basic and diluted), compared to a net loss of $5.2 million, or $0.51 net loss per share (basic and diluted), for the three months ended December 31, 2019. Net loss for the year ended December 31, 2020 was $22.9 million, or $2.06 loss per share (basic and diluted), compared to a net loss of $29.4 million, or $2.91 loss per share (basic and diluted), for the year ended December 31, 2019.

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.