ACER Acer Therapeutics Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): August 14, 2023

ACER THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

 

Delaware		001-33004		32-0426967
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

One Gateway Center, Suite 356 300 Washington Street Newton, Massachusetts		02458
(Address of principal executive offices)		(Zip Code)
Registrant’s telephone number, including area code: (844) 902-6100
N/A
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Common Stock, $0.0001 par value per share	ACER	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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Item 2.02. Results of Operations and Financial Condition

On August 14, 2023, Acer Therapeutics Inc. filed its Quarterly Report on Form 10-Q for the three months ended June 30, 2023 and announced the results of operations in a press release. A copy of the press release announcing the results is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.		Description
99.1		Press release issued by Acer Therapeutics Inc. on August 14, 2023.
104		Cover page interactive data file (embedded within the inline XBRL document).

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Dated: August 14, 2023	ACER THERAPEUTICS INC.
	By:	/s/ Harry S. Palmin
		Harry S. Palmin
		Chief Financial Officer

 

 

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	Exhibit 99.1

 

Acer Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

 

OLPRUVA™ (sodium phenylbutyrate) kits now available in all dosage strengths and ready to ship to patients

 

NEWTON, MA – August 14, 2023 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.

 

“The second quarter of 2023 marked continued progress for Acer as we execute on our OLPRUVA™ launch strategy,” said Chris Schelling, CEO and Founder of Acer. “We are pleased to offer OLPRUVA™ in the U.S. to certain UCD patients as a novel alternative option to current treatments that was specifically designed for palatability and convenience.1,2 With OLPRUVA™ kits now available in all dosage strengths, we are committed to supporting patients from initial prescription to support throughout the treatment process, and look forward to making OLPRUVA™ available to patients in need.”

 

Program and Corporate Highlights

Anticipated Milestones (Subject to Available Capital)

 

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Q2 2023 Financial Results

 

Cash Position. Cash and cash equivalents were $1.6 million as of June 30, 2023, compared to $2.3 million as of December 31, 2022. Acer believes its cash and cash equivalents at June 30, 2023 will be sufficient to fund its anticipated operating and capital requirements through the middle of the third quarter of 2023.

Research and Development Expenses. Research and development expenses were $1.4 million, net of collaboration funding of $0.6 million, for the three months ended June 30, 2023, as compared to $3.4 million, net of collaboration funding of $1.6 million, for the three months ended June 30, 2022. This decrease of $2.0 million was primarily due to decreases in expenses for clinical studies, employee-related expenses, expenses for consulting and professional services, and contract manufacturing expenses. Research and development expenses related to ACER-001 decreased in the three months ended June 30, 2023, resulting in a decrease in the recognition of the collaboration funding from the Collaboration Agreement with Relief. Research and development expenses for the three months ended June 30, 2023 were comprised of $1.0 million related to EDSIVOTM; $0.6 million related to ACER-001, offset by $0.6 million of collaboration funding; $0.2 million related to ACER-801; and $0.2 million related to other development activities.

General and Administrative Expenses. General and administrative expenses were $2.9 million, net of collaboration funding of $1.4 million, for the three months ended June 30, 2023, as compared to $3.6 million, net of collaboration funding of $3.3 million, for the three months ended June 30, 2022. This decrease of $0.7 million was primarily due to decreases in marketing expenses, expenses for consulting and professional services, and employee-related expenses. General and administrative expenses related to ACER-001 decreased in the three months ended June 30, 2023, resulting in a decrease in the recognition of the collaboration funding from the Collaboration Agreement with Relief.

 

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Net Loss. Net loss for the three months ended June 30, 2023 was $8.1 million, or $0.33 net loss per share (basic and diluted), compared to a net loss of $2.7 million, or $0.17 net loss per share (basic and diluted), for the three months ended June 30, 2022.

For additional information, please see Acer’s Quarterly Report on Form 10-Q filed today with the Securities and Exchange Commission (SEC).

About Acer Therapeutics

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 U.S., OLPRUVA™ (sodium phenylbutyrate) is approved for the treatment of UCDs involving deficiencies of CPS, OTC, or AS. Acer is also advancing a pipeline of investigational product candidates for rare and life-threatening diseases, including: OLPRUVA™ (sodium phenylbutyrate) for treatment of various disorders, including Maple Syrup Urine Disease (MSUD); and EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation. For more information, visit www.acertx.com.

 

References

 

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 U.S. for the treatment of certain patients with certain UCDs, including progress with respect to discussions with commercial and government insurance providers, physicians outreach and awareness, and patient support and fulfillment, statements with respect to our EDSIVO clinical trial for patients with vEDS, including enrollment and timing milestones related thereto, statements about our anticipated 2023 milestones, statements about our investment of OLPRUVA revenue, and statements about our capital requirements and sufficiency and duration of our current cash and cash equivalents. Our efforts to commercialize OLPRUVA™ for oral suspension in the U.S. for the treatment of certain patients with UCDs involving deficiencies of CPS, OTC, or AS are at an early stage, we currently do not have fully developed marketing, sales or distribution capabilities, and there is no guarantee that we will be successful in our commercialization efforts. Our pipeline products (including

 

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OLPRUVA™ for indications other than UCDs as well as EDSIVO™ and ACER-801) 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 health authority approval or become commercially available for the uses being investigated. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such 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 as a result of many factors, including, without limitation, the availability of financing to fund our commercialization efforts, our pipeline product development programs and our general corporate operations as well as risks related to drug development and the regulatory approval process, including the timing and requirements of regulatory actions. We disclaim any intent 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 additional disclosures we make in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. You may access these documents for no charge at http://www.sec.gov.

 

 

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ACER THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

	Three Months Ended
	June 30,
	2023				2022
Operating expenses:
Research and development (net of collaboration      funding of $600,072 and $1,648,631 in the three      months ended June 30, 2023 and 2022, respectively)	$	1,440,717			$	3,426,773
General and administrative (net of collaboration      funding of $1,404,695 and $3,257,701 in the three      months ended June 30, 2023 and 2022, respectively)		2,853,760				3,638,073
Loss from operations		(4,294,477	)			(7,064,846	)
Other income (expense), net:
Costs of debt issuance		—				(200,129	)
Loss on extinguishment of debt		(350,000	)			—
Changes in fair value of debt instruments (loss) gain		(2,806,538	)			4,729,460
Interest and other income (expense), net		(639,610	)			(139,234	)
Foreign currency transaction (loss) gain		(95	)			7,713
Total other income (expense), net		(3,796,243	)			4,397,810
Net loss	$	(8,090,720	)		$	(2,667,036	)
Net loss per share - basic	$	(0.33	)		$	(0.17	)
Weighted average common shares outstanding - basic		24,462,895				15,273,707
Net loss per share - diluted	$	(0.33	)		$	(0.30	)
Weighted average common shares outstanding - diluted		24,462,895				17,681,400

 

 

 

 

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SELECTED BALANCE SHEET DATA (Unaudited):

 

 

		June 30,				December 31,
		2023				2022
Cash and cash equivalents		$	1,553,416			$	2,329,218
Inventory		$	4,600,618			$	—
Prepaid expenses		$	583,339			$	759,292
Deferred financing costs		$	—			$	408,000
Other current assets		$	14,638			$	20,188
Property and equipment, net		$	54,273			$	214,578
Total assets		$	14,648,276			$	11,624,226
Accounts payable and accrued expenses		$	10,438,490			$	7,470,674
Promissory Note payable to an officer		$	1,000,000			$	—
Deferred collaboration funding, total		$	4,547,198			$	8,412,971
SWK Loans payable, at fair value		$	17,986,848			$	5,567,231
Convertible note payable, at fair value		$	13,078,200			$	6,047,532
Total liabilities		$	47,894,494			$	28,385,498
Total stockholders’ deficit		$	(33,246,218	)		$	(16,761,272	)

 

 

 

 

 

 

 

 

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Corporate and IR Contact

 

Jim DeNike

Acer Therapeutics Inc.

jdenike@acertx.com

+1-844-902-6100

 

Nick Colangelo

Gilmartin Group

nick@gilmartinIR.com

+1-332-895-3226

 

 

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v3.23.2

Document and Entity Information	Aug. 14, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Entity Central Index Key	0001069308
Document Period End Date	Aug. 14, 2023
Entity Registrant Name	ACER THERAPEUTICS INC.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-33004
Entity Tax Identification Number	32-0426967
Entity Address, Address Line One	One Gateway Center
Entity Address, Address Line Two	Suite 356
Entity Address, Address Line Three	300 Washington Street
Entity Address, City or Town	Newton
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02458
City Area Code	844
Local Phone Number	902-6100
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	ACER
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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