“The first quarter of 2023 was marked by considerable progress and a number of significant milestones in support of our commercial launch of OLPRUVA™, an innovative treatment option for patients with certain Urea Cycle Disorders (UCDs),” said
Q1 2023 and Recent Highlights
- OLPRUVA™ (sodium phenylbutyrate) for oral suspension
- In
March 2023 , Acer announced the presentation of data at the Annual Meeting of theSociety for Inherited Metabolic Disorders (SIMD) from a survey of UCD healthcare providers sponsored by Acer that indicated taste and odor were the most important attributes when considering treatment options and treatment adherence - Also at the SIMD Annual Meeting, Acer representatives met with 33 metabolic treatment providers -- including nurse practitioners, registered dieticians, and physicians – from 24 metabolic treatment centers throughout the
U.S. Of those metabolic treatment providers surveyed by Acer, 70% expressed a high interest in treating at least one of their patients with OLPRUVA™ in 2023 - In preparation for OLPRUVA™’s planned drug-in-channel in
mid-June 2023 , the Company is in discussions with the major pharmacy benefits managers (PBM) and group purchasing organizations (GPO) representing a substantial majority of covered lives - Acer has also established a responsible and competitive pricing strategy designed to offer UCD patients a new treatment option at a significant discount to RAVICTI® while delivering predictable pricing that will not increase beyond the rate of inflation. Acer also plans to invest a portion of OLPRUVA™ revenue back into additional solutions aimed at improving outcomes for UCD patients
- Finally, Acer has established and staffed its patient support program, Navigator by
Acer Therapeutics , that includes a suite of services designed to provide streamlined and efficient prescription management -- including benefits verification, education, and home delivery -- and personalized support for OLPRUVA™ patients
- In
- EDSIVO™ (celiprolol)
- Acer continues to enroll patients in its ongoing, pivotal Phase 3 Decentralized Study of Celiprolol on vEDS-related Event Reduction (DiSCOVER) clinical trial of EDSIVO™ (celiprolol) in patients with COL3A1-positive vEDS. The double-blind portion of the DiSCOVER trial is designed to include an interim analysis conducted after 28 vEDS related events, which could occur as early as approximately 18 months after completion of full enrollment; and end if statistical significance is reached after 46 vEDS-related events, estimated to occur as early as approximately 40 months after completion of full enrollment
- ACER-801
- In
March 2023 , Acer announced topline results from its Phase 2a trial evaluating ACER-801 (osanetant) for the treatment of moderate to severe Vasomotor Symptoms (VMS) associated with menopause. The trial showed that ACER-801 was generally safe and well-tolerated but did not achieve statistically significant decrease in frequency or severity of hot flashes in postmenopausal women. As a result, Acer has paused the ACER-801 program until it has completed a thorough review of the full data set from the Phase 2a trial
- In
- Corporate
- Ended Q1 2023 with
$6.4 million in cash and cash equivalents. Acer believes its cash and cash equivalents available atMarch 31, 2023 , together with$0.4 million from Acer’s ATM facility subsequent toMarch 31, 2023 , will be sufficient to fund its anticipated operating and capital requirements into late in the second quarter of 2023
- Ended Q1 2023 with
Anticipated Milestones (Subject to
- Mid-to-Late
May 2023 : Acer expects to publish OLPRUVA™’s list price, or wholesale acquisition cost (WAC), in mid-to-lateMay 2023 June 2023 : Acer anticipates OLPRUVA™ drug availability inmid-June 2023 - 2H 2023: Acer expects to begin attaining OLPRUVA™ commercial insurance coverage in 2H 2023
- Q3 2023: Acer expects to begin attaining insurance coverage for OLPRUVA™ Medicaid patients starting in Q3 2023
- Year End 2023: Acer anticipates enrollment completion by end of 2023 in its ongoing, pivotal Phase 3 DiSCOVER trial of EDSIVO™ in patients with COL3A1-positive vEDS
- Acer also intends to pursue additional opportunities for potential OLPRUVA™ label expansion, including the potential for additional dosage strengths to address patients with lower weights/body surface areas, and potential administration using a gastrostomy tube (G-tube)
Q1 2023 Financial Results
Cash Position. Cash and cash equivalents were
Research and Development Expenses. Research and development expenses were
General and Administrative Expenses. General and administrative expenses were
Net Loss. Net loss for the three months ended
For additional information, please see Acer’s Quarterly Report on Form 10-Q filed today with the
About
Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. In the
Acer Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. Examples of such statements include, but are not limited to, statements about plans and strategy for the commercialization of OLPRUVA™ for oral suspension in the
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) | |||||||
Three Months Ended | |||||||
2023 | 2022 | ||||||
Operating expenses: | |||||||
Research and development (net of collaboration funding of | $ | 2,421,120 | $ | 3,171,639 | |||
General and administrative (net of collaboration funding of | 2,568,181 | 3,875,601 | |||||
Loss from operations | (4,989,301 | ) | (7,047,240 | ) | |||
Other income (expense), net: | |||||||
Costs of debt issuance | (577,225 | ) | (1,168,065 | ) | |||
Loss on extinguishment of debt | (8,191,494 | ) | — | ||||
Changes in fair value of debt instruments | (2,211,685 | ) | (962,400 | ) | |||
Interest and other income (expense), net | (286,537 | ) | (2,838 | ) | |||
Foreign currency transaction (loss) gain | (24,464 | ) | 1,539 | ||||
Total other income (expense), net | (11,291,405 | ) | (2,131,764 | ) | |||
Net loss | $ | (16,280,706 | ) | $ | (9,179,004 | ) | |
Net loss per share - basic and diluted | $ | (0.77 | ) | $ | (0.64 | ) | |
Weighted average common shares outstanding - basic and diluted | 21,113,166 | 14,310,244 |
SELECTED BALANCE SHEET DATA (Unaudited):
2023 | 2022 | |||||||
Cash and cash equivalents | $ | 6,379,977 | $ | 2,329,218 | ||||
Inventory | $ | 412,038 | $ | — | ||||
Prepaid expenses | $ | 800,777 | $ | 759,292 | ||||
Deferred financing costs | $ | — | $ | 408,000 | ||||
Other current assets | $ | 14,638 | $ | 20,188 | ||||
Property and equipment, net | $ | 202,097 | $ | 214,578 | ||||
Total assets | $ | 15,672,096 | $ | 11,624,226 | ||||
Accounts payable and accrued expenses | $ | 5,918,621 | $ | 7,470,674 | ||||
Deferred collaboration funding | $ | 6,551,965 | $ | 8,412,971 | ||||
SWK Loans payable, at fair value | $ | 17,057,110 | $ | 5,567,231 | ||||
Convertible note payable current, at fair value | $ | 11,392,167 | $ | 6,047,532 | ||||
Total liabilities | $ | 41,785,695 | $ | 28,385,498 | ||||
Total stockholders’ deficit | $ | (26,113,599 | ) | $ | (16,761,272 | ) |
Corporate and IR Contact
jdenike@acertx.com
+1-844-902-6100
nick@gilmartinIR.com
+1-332-895-3226
Source:
2023 GlobeNewswire, Inc., source