Acer

Acer Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update

Acer Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update

Acer Therapeutics Inc.

NEWTON, Mass., May 16, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on acquiring, developing and commercializing therapies for serious, rare and life-threatening diseases Medical, today announced its financial results for the first quarter ended March 31, 2022 and provides an update on recent business developments.

“Progress in the first quarter of 2022 was marked by a transformative debt financing in March, with continued progress towards the potential commercial launch of ACER-001 for UCDs and the development of our other pipeline programs,” said Chris. Schelling, CEO and Founder of Acer. “Our progress to date has positioned Acer for the potential achievement of a number of important milestones planned through the end of 2022, including an FDA decision on our ACER-001 New Drug Application in June, the planned initiation of our pivotal Phase 3 EDSIVO™ trial in vascular Ehlers-Danlos syndrome under our SPA agreement with the FDA by the end of the second quarter of 2022, and the results of the phase trial 2a ACER-801 in vasomotor symptoms in the second half of 2022.”

Q1 2022 and recent highlights

Planned milestones

Financial results for the 1st quarter of 2022

Cash position. Cash and cash equivalents were $20.8 million as of March 31, 2022, compared to $12.7 million as of December 31, 2021. Acer estimates that its available cash and cash equivalents as of March 31, 2022 will be sufficient to fund its currently planned operating and capital expenditures. requirements in Q3 2022.

Research and development expenses. Research and development expenses were $3.2 million, net of collaboration funding of $3.0 million, for the quarter ended March 31, 2022, compared to $2.0 million, net of collaboration funding of $0.3 million, for the quarter ended March 31, 2021. the increase of $1.2 million was primarily due to higher contract manufacturing expenses, related to employees, including an accumulation of one-time bonuses, and clinical and medical business expenses, partially offset by the recognition of $3.0 million of collaboration funding from the collaboration agreement with The Relief. Research and development expenses for the three months ended March 31, 2022 included $3.1 million related to ACER-001, offset by $3.0 million in collaboration funding; $1.3 million related to ACER-801; $1.2 million related to EDSIVO™; $0.5 million related to other development activities.

General and administrative expenses. General and administrative expenses were $3.9 million, net of collaboration funding of $2.4 million for the quarter ended March 31, 2022, compared to $3.5 million for the quarter ended March 31, 2021. This increase of $0.4 million is primarily due to increases in pre-commercial expenses, audit and advisory fees, and employee-related expenses, including an accumulation of one-time bonuses, partially offset through the recognition of $2.4 million in Collaborative Funding from the Collaborative Agreement with Relief.

Net loss. Net loss for the three months ended March 31, 2022 was $9.2 million, or $0.64 net loss per share (basic and diluted), compared to a net loss of 4.6 million, or $0.33 net loss per share (basic and diluted), for the three months ended March 31, 2021.

For more information, please see Acer’s Quarterly Report on Form 10-Q filed today with the SEC.

About Acer Therapeutics Inc.

Acer is a pharmaceutical company focused on acquiring, developing and commercializing therapies for serious, rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four experimental programs: ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCD) and maple syrup urinary disease (MSUD); ACER-801 (osanetant) for the treatment of induced vasomotor symptoms (iVMS); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed collagen type III (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of viruses, including cytomegalovirus, zika, dengue, ebola and COVID-19. For more information, visit www.acertx.com.

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 fact, included in this press release regarding strategy, future operations, clinical study enrollment deadlines or regulatory actions, or otherwise, future financial condition, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, outlook, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential of our investigational product candidates to safely and effectively treat disease and be approved for commercialization; our ability to enter into and obtain proceeds from any identified financing agreement as well as to satisfy outstanding conditions and requirements to maintain the financing facilities and avoid a default or accelerated payment requirement; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability, in addition to currently identified funding, to secure the additional capital needed to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to fund, initiate and successfully complete clinical trials and regulatory submissions for ACER-001, ACER-801, EDSIVO™ or our other product candidates; the ability to protect our intellectual property rights; our strategy and business direction; and the development, anticipated timing and commercial potential of each of our product candidates. Our products in development are under investigation and their safety and efficacy have not been established and there is no guarantee that any of our investigational products in development will receive approval from health authorities or will become commercially available for the uses investigated. We may not actually achieve the plans, achieve the intentions or meet the expectations or projections disclosed in any forward-looking statements and you should not place undue reliance on such forward-looking statements. These statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements due to many factors, including, without limitation, risks and uncertainties associated with the ability to project future use of cash and reserves necessary for contingent future liabilities and business operations. , the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of prior studies and trials may not be predictive of the results of future clinical trials, the protection and market exclusivity provided by our intellectual property, the risks associated with the drug development and regulatory approval process, including the timing and requirements of regulatory action, and the impact of products competitors and technological changes. We disclaim any intention or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review the additional disclosures we make in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and our Quarterly Report on Form 10-Q. You can access these documents free of charge at http://www.sec.gov.

ACER THERAPEUTIC INC.
CONSOLIDATED INCOME STATEMENTS
(Unaudited)

Three months completed

March, 31st,

2022

2021

Revenue

$

$

900,000

Operating costs :

Research and Development (during the three months ended March 31, 2022 and 2021, net of collaboration funding of $2,999,371 and $286,103, respectively)

3,171,639

2,005,905

General and administrative (during the three months ended March 31, 2022 and 2021, net of collaboration funding of $2,372,175 and $0, respectively)

3,875,601

3,514,141

Operating loss

(7,047,240

)

(4,620,046

)

Other (expenses) income, net:

Debt issuance costs

(1,168,065

)

Changes in fair value of debt instruments

(962,400

)

Interest and other (expenses) income, net

(2,838

)

(40,163

)

Foreign currency transaction gain

1,539

48,904

Total other (expense) income, net

(2,131,764

)

8,741

Net loss

$

(9,179,004

)

$

(4,611,305

)

Net loss per share – basic and diluted

$

(0.64

)

$

(0.33

)

Weighted average common shares outstanding – basic and
diluted

14,310,244

14,139,916

SELECTED BALANCE SHEET DATA (unaudited):

March, 31st,

The 31st of December,

2022

2021

Cash and cash equivalents

$

20,800,384

$

12,710,762

Collaboration to receive

$

$

5,000,000

Prepaid expenses

$

1,525,016

$

1,094,229

Other current assets

$

1,028,427

$

9,283,625

Property and equipment, net

$

122,436

$

114 112

Total assets

$

31,469,491

$

36,256,951

Deferred collaboration funding

$

19,115,501

$

24,487,047

Bridge loan payable, at fair value

$

6,172,969

$

Convertible note payable, at fair value

$

6,962,400

$

Total responsibilities

$

41,570,972

$

37,980,556

Total shareholder deficit

$

(10,101,481

)

$

(1,723,605

)

Corporate Contact:
Jim DeNike
Acer Therapeutics Inc.
+1-844-902-6100
[email protected]

Contact with Investor Relations:
Nick Colangelo
Gilmartin Group
+1-339-225-1047
[email protected]