- Acer Therapeutics Inc (NASDAQ: ACER) stock price rose more than 100% before market at 6:00 a.m. ET. This is what you need to know about the business.
The share price of Acer Therapeutics Inc (NASDAQ: ACER) – a pharmaceutical company that focuses on the acquisition, development and commercialization of therapies for rare and life-threatening serious diseases – has risen by more than 100 % pre-market as of 6:00 a.m. ET. This is what you need to know about the business.
There are rumors about the company that it could potentially merge with Relief Therapeutics. Relief Therapeutics recently announced that it has entered into a definitive agreement with a single US institutional investor dedicated to healthcare to purchase as part of a private placement 41,459,370 ordinary shares of Relief at a purchase price of CHF 0.2412 per share. The total gross proceeds of the private placement are expected to be approximately CHF 10 million, before deduction of placement agent fees and offering fees payable by Relief.
On March 1, Acer Therapeutics released its results for the fourth quarter and fiscal year ended December 31, 2020.
Q4 2020 and recent highlights
– Signature of an option agreement with Relief Therapeutics Holding AG on January 25, 2021, granting Relief exclusivity until June 30, 2021, for the right to pursue a possible collaboration and license agreement for the development and worldwide commercialization of ACER-001. And in return, Acer received an initial non-repayable payment of $ 1 million and a secured loan of $ 4 million from Relief.
– Announcement in February 2021 of the first results of the Acer’s bioequivalence test in which ACER-001 showed a relative bioavailability similar to that of BUPHENYL® (sodium phenylbutyrate) under fed conditions
– Announcement in December 2020 of the publication by Swedish researchers of additional long-term data from patients with COL3A1-positive vascular Ehlers-Danlos syndrome (vEDS) in the European Journal of Vascular and Endovascular Surgery entitled “Celiprolol Treatment in Patients with Vascular Ehlers-Danlos Syndrome »
– Submission of a request for a Type B meeting to the FDA in February 2021 to discuss the plan proposed by Acer to collect additional data and provide confirmatory evidence in support of the potential benefit of celiprolol in the treatment of affected patients of SED COL3A1 positive
– Completed Active Pharmaceutical Ingredient (API) manufacturing and advanced other development activities to support an Investigational New Drug Application (IND) submission
– Promoted Jefferson Davis to Chief Business Officer in February 2021. A seasoned life sciences executive and transaction specialist with over 25 years of experience in business and enterprise development, Mr. Davis has led or supported over 40 transactions with a total value of over $ 2 billion across all major therapeutic platforms, including antibodies, small molecules, aptamers, gene therapy, vaccines and proteins
– End of the fourth quarter with $ 5.8 million in cash and cash equivalents. Acer estimates that its cash position as at December 31, 2020, combined with additional net proceeds of $ 3.2 million received from the sale of common shares under its ATM and through its agreement capital line purchase with Lincoln Park Capital, as well as the $ 1.0 million non-repayable payment and $ 4.0 million secured loan received from Relief Therapeutics following the signing of the ACER-001 option agreement will be sufficient to finance its operations until the third quarter of 2021
Q2 2021: Targeting of a New Drug Pre-Application (NDA) meeting with the FDA in Q2 2021, assuming the success of ongoing development activities
Mid-2021: Submission of ACER-001 NDA for the treatment of patients with urea cycle disorders (UCD) is expected in mid-2021, provided that no additional data is requested by FDA at Acer’s pre-NDA meeting and ongoing development activities to be successfully completed (including evaluation of long-term product stability data)
Q2 2021: Obtain comments from the FDA at a Type B meeting in Q2 2021 regarding Acer’s proposed plan to collect additional data – which, if discussions are successful and sufficient data collected, could potentially satisfy the substantial evidence of effectiveness necessary to support a resubmission of the EDSIVO NDA (although neither resubmission nor approval of the EDSIVO NDA is assured)
Q3 2021: IND submission for osanetant is scheduled for Q3 2021
Q4 2021: The launch of a phase 2 clinical trial on osanetant in BRCA-positive patients who underwent prophylactic bilateral salpingo-oophorectomy (PBSO) is scheduled for the fourth quarter of 2021, subject to the success of the IND case and subject to additional capital
Ongoing: Further progress of the emetine program for infectious diseases, including COVID-19, depends on Acer’s ability to raise non-dilutive capital
Ongoing: The company believes that most work to activate the emetin IND is underway or completed, and intends to minimize future spending on emetin as it continues to work with federal agencies and agencies. private research organizations in order to obtain non-dilutive funding
Q4 and Year 2020 Financial Results
Cash and cash equivalents were $ 5.8 million as at December 31, 2020, compared to $ 12.1 million as at December 31, 2019. Acer estimates that its cash and cash equivalents were available as at December 31, 2020 , combined with additional net proceeds of $ 3.2 million thereafter. received from the sale of common stock as part of its ATM service and through its capital line purchase agreement with Lincoln Park Capital, as well as the $ 1.0 million non-repayable payment and loan The $ 4.0 million guarantee received from Relief Therapeutics following the signing of the ACER-001 option agreement will be sufficient to fund its operations until the third quarter of 2021.
Research and development costs
Research and development costs amounted to $ 3.5 million for the quarter ended December 31, 2020, compared to $ 2.8 million for the quarter ended December 31, 2019. Research and development costs for the quarter ended December 31, 2020 included $ 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 amounted to $ 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 is primarily attributable to lower spending on personnel and spending on clinical and other consulting services, partially offset by an increase in contract research spending.
General and administrative expenses
General and administrative expenses amounted to $ 2.7 million for the quarter ended December 31, 2020, compared to $ 2.4 million for the quarter ended December 31, 2019. General and administrative expenses amounted to $ 11.0 million for the year ended December 31, 2020, compared to $ 16.0 million. million for the year ended December 31, 2019. This decrease of $ 5.0 million is mainly due to lower personnel expenses and expenses related to pre-commercial activities, partially offset by an increase in legal fees . This decrease in personnel expenses is the result of a reduction in the workforce following the restructuring initiative undertaken after receipt of the Full Response Letter from the FDA for EDSIVO ™ in June 2019.
The net loss for the quarter 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 quarter ended December 31, 2019. The net loss for the year ended December 31, 2020 was $ 22.9 million, or a loss of $ 2.06 per share (basic and diluted), compared to a net loss of $ 29.4 million, or loss of $ 2.91 per share (basic and diluted), for the year ended December 31, 2019.
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