Author: Editor

NEWTON, MA – September 24, 2018 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical need, today announced that Acer’s management team will provide a corporate overview at the 2018 Cantor Global Healthcare Conference, being held October 1-3, 2018 in New York City.

 

Acer Conference Presentation Details

Date:                     Wednesday, October 3

Time:                     11:30 am Eastern Time

Location:               InterContinental Barclay Hotel, Track 5 – Grand Ballroom 2

Webcast:               https://www.acertx.com/investor-relations/events-presentations/

 

About Acer Therapeutics

Acer, headquartered in Newton, MA, is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for patients with serious rare and ultra-rare diseases with critical unmet medical need. Acer’s late-stage clinical pipeline includes two candidates for severe genetic disorders: EDSIVO™ (celiprolol) for vascular Ehlers-Danlos syndrome (vEDS), and ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate) for urea cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). There are no FDA-approved drugs for vEDS and MSUD and limited options for UCD, which collectively impact approximately 7,000 patients in the U.S. Acer’s product candidates have clinical proof-of-concept and mechanistic differentiation, and Acer intends to seek approval for them in the U.S. by using the regulatory pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) that allows an applicant to rely at least in part on third-party data for approval, which may expedite the preparation, submission, and approval of a marketing application.

 

For more information, visit www.www.acertx.com.

 

Investor Contact:

Hans Vitzthum

LifeSci Advisors

Ph: 617-535-7743

[email protected]

NEWTON, MA – August 20, 2018 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical need, today announced that Acer’s management team will provide a corporate overview at the H.C. Wainwright 20th Annual Global Investment Conference, being held on September 4-6, 2018 in New York City.

 

Acer Conference Presentation Details

Date:            Wednesday, September 5

Time:           10:25 am Eastern Time

Location:     St. Regis New York, in Library (2nd floor)

Webcast:     https://www.acertx.com/investor-relations/events-presentations/

 

About Acer Therapeutics

Acer, headquartered in Newton, MA, is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for patients with serious rare and ultra-rare diseases with critical unmet medical need. Acer’s late-stage clinical pipeline includes two candidates for severe genetic disorders: EDSIVO™ (celiprolol) for vascular Ehlers-Danlos syndrome (vEDS), and ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate) for urea cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). There are no FDA-approved drugs for vEDS and MSUD and limited options for UCD, which collectively impact approximately 7,000 patients in the U.S. Acer’s product candidates have clinical proof-of-concept and mechanistic differentiation, and Acer intends to seek approval for them in the U.S. by using the regulatory pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) that allows an applicant to rely at least in part on third-party data for approval, which may expedite the preparation, submission, and approval of a marketing application.

 

For more information, visit www.www.acertx.com.

 

Investor Contact:

Hans Vitzthum

LifeSci Advisors

Ph: 617-535-7743

[email protected]

Acer Therapeutics Reports Second Quarter 2018 Financial Results and Provides Corporate Update

 

Acer continues to progress towards goal of commercializing EDSIVO™

 

Company appoints VPs of Medical Affairs and Quality

 

NEWTON, MA – August 13, 2018 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical need, today reported financial results for the quarter ended June 30, 2018 and provided an update on the Company’s recent corporate developments. The Company also announced that it has appointed Dr. Usman Iqbal as Vice President, Medical Affairs; and Ms. Nancy Duarte-Lonnroth as Vice President, Quality.

 

“We continue to progress towards finalizing the planned submission of a New Drug Application (NDA) for EDSIVO™ in vascular Ehlers-Danlos syndrome (vEDS) early in the fourth quarter of this year. We have also strengthened our balance sheet and continue with pre-commercial activities,” said Chris Schelling, CEO and Founder of Acer. “As part of the pre-commercial preparation, we have made two important senior-level hires. Our new team members bring deep industry knowledge and experience across medical affairs and quality, which will be invaluable as we move forward. I warmly welcome Usman, who will report to our Chief Medical Officer, and Nancy, who will report to our Chief Legal Officer.”

 

“Also, we are active in supporting patient advocacy initiatives and are working very closely with the vEDS community to best understand their needs in addressing this devastating disease,” Mr. Schelling continued. “Beyond vEDS, we intend to work on advancing and expanding our pipeline with the goal of bringing multiple products to patients with serious ultra-orphan diseases over the next several years.”

 

Second Quarter 2018 and Recent Highlights

⦁ Held a Type C clinical meeting and a Type B (pre-NDA) meeting with the FDA in June 2018

⦁ Presented celiprolol vEDS Patient Registry data to the FDA at the Type C meeting; if published, it will be included in support of NDA but is not rate-limiting to submission of NDA

⦁ Raised $46 million, including underwriters’ full exercise of their option to purchase additional shares to cover over-allotments, through an oversubscribed underwritten public offering in August 2018⦁ Ended second quarter with $8.3 million in cash and cash equivalents and no debt, which together with approximately $42.5 million of net proceeds from the public offering, we believe will be sufficient to fund our current operating and capital requirements into the first half of 2020

⦁ Expanded management team by hiring Dr. Usman Iqbal as Vice President, Medical Affairs; and Nancy Duarte-Lonnroth as Vice President, Quality

 

Upcoming Milestones

⦁ Potential publication of celiprolol vEDS Patient Registry data; the manuscript is currently under peer review

⦁ Targeting NDA submission to the FDA for EDSIVO™ for the treatment of vEDS in early fourth quarter of 2018

⦁ Requesting priority review for EDSIVO™ which, if granted at the time of potential acceptance of NDA for filing, could result in a Prescription Drug User Free Act (PDUFA) action date of late second quarter 2019

⦁ Continuing pre-commercial activities for EDSIVO™

⦁ Making additional senior-level commercial hires this year, as well as continuing to build out the commercial team and add other core personnel later this year

 

Financial Results for the Second Quarter 2018

 

Cash position. Cash and cash equivalents were $8.3 million as of June 30, 2018, compared to $15.6 million as of December 31, 2017. We believe our cash position, together with approximately $42.5 million of net proceeds from the August 2018 public offering, will be sufficient to fund our current operating and capital requirements into the first half of 2020.

 

Research and Development Expenses. Research and development expenses were $2.7 million during the three months ended June 30, 2018, compared to $1.9 million during the three months ended June 30, 2017. This increase of $0.8 million was principally due to increases in spending for regulatory consulting, employee costs, and contract research, partially offset by a decrease in manufacturing services, all relating to EDSIVO™. Research and development expense for the three months ended June 30, 2018, was comprised of approximately $2.4 million related to EDSIVO™ and $0.3 million related to ACER-001.

 

General and Administrative Expenses. General and administrative expenses were $2.2 million for the three months ended June 30, 2018 compared to $1.2 million for the three months ended June 30, 2017. This increase of $1.0 million was primarily due to an increase in pre-commercial and personnel costs, partially offset by lower legal and consulting related expenses.

 

Net Loss. Net loss for the three months ended June 30, 2018 was $4.8 million, or $0.64 loss per share (basic and diluted), compared to a net loss of $3.1 million, or $1.29 loss per share (basic and diluted), for the three months ended June 30, 2017.

 

For additional information, please see our Quarterly Report on Form 10-Q filed today with the SEC.

 

About Usman Iqbal MD, MPH, MBA

Dr. Iqbal joined Acer as Vice President, Medical Affairs in July 2018. Dr. Iqbal is a medical executive with a portfolio career entailing 15 years of diverse experience spanning Medical Affairs and end-to-end evidence and value development, across both large and small cap biopharmaceuticals. His experience spans a number of therapeutic areas including in Neuroscience, as Senior Medical Affairs Leader at AstraZeneca, and in Oncology, as former Head of Sanofi Oncology, Global Evidence & Value Development (GEVD). With positions of increasing responsibilities across both R&D and Medical Affairs in different organizations, Dr. Iqbal has led five product launches, built several integrated and transversal medical affairs platforms, and led the development and execution of integrated medical affairs strategy for broad portfolios including several orphan drugs. His area of expertise also includes harnessing of big data science, advanced analytics and digital medicine to optimize medical affairs delivery and patient outcomes. Prior to working in the industry that also includes Amgen and Trevena, Dr. Iqbal was at the Boston University Health Outcomes Technology Group where he served as a senior research fellow at the Center for Assessment of Pharmaceutical Practices (CAPPs) and Veterans Affairs Pharmacy Benefit Management (VA-PBM). Dr. Iqbal serves as advisor to several academic and health care think tanks as an industry thought leader. He received his MD from Allama Iqbal Medical College, Lahore, Pakistan and MPH and MBA degrees from Boston University.

 

About Nancy Duarte-Lonnroth

Ms. Lonnroth joined Acer as Vice President, Quality in May 2018. She brings more than 20 years of experience implementing, improving and directing Quality initiatives in highly regulated global life science companies. Ms. Lonnroth is a subject matter expert in Quality Assurance (QA) / Quality Control (QC) and Quality Management Systems (QMS) and has successfully hosted several FDA and other agency inspections and customer/partner audits. Prior to Acer, she has held leadership positions in Commercial and Pre-Commercial Quality at companies including AMAG Pharmaceuticals, Celestica, Acusphere, Histogenics, Stryker Biotech and Alkermes. Ms. Lonnroth obtained her US Regulatory Affairs Certification (RAC[US]) from RAPS in 2011. She received her B.A. degree in Modern Languages and B.S./M.S. degrees in Chemistry from University of Massachusetts, Lowell and her MBA from Franklin Pierce University.

 

About Acer Therapeutics

Acer, headquartered in Newton, MA, is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for patients with serious rare and ultra-rare diseases with critical unmet medical need. Acer’s late-stage clinical pipeline includes two candidates for severe genetic disorders: EDSIVO™ (celiprolol) for vascular Ehlers-Danlos syndrome (vEDS), and ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate) for urea cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). There are no FDA-approved drugs for vEDS and MSUD and limited options for UCD, which collectively impact approximately 7,000 patients in the U.S. Acer’s product candidates have clinical proof-of-concept and mechanistic differentiation, and Acer intends to seek approval for them in the U.S. by using the regulatory pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) that allows an applicant to rely at least in part on third-party data for approval, which may expedite the preparation, submission, and approval of a marketing application.

 

For more information, visit www.www.acertx.com.

 

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 regarding strategy, future operations, future financial position, future revenues, projected expenses, regulatory approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to expectations regarding our capitalization and resources; the potential for EDSIVO™ (celiprolol) and ACER-001 to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity in any target indication; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; the nature, strategy and our focus; future economic conditions or performance; and the development, expected timeline and commercial potential of any of our product candidates. 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, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

 

ACER THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

		Three Months Ended June 30,
		2018				2017
Operating expenses:
Research and development		$	2,688,159			$	1,857,856
General and administrative			2,227,947				1,156,494
Total operating expenses			4,916,106				3,014,350
Loss from operations			(4,916,106	)			(3,014,350	)
Other income (expense):
Interest income			36,555				1,425
Interest expense			—				(109,722	)
Foreign currency transaction gain			44,061				—
Total other income (expense), net			80,616				(108,297	)
Net loss		$	(4,835,490	)		$	(3,122,647	)
Net loss per share – basic and diluted		$	(0.64	)		$	(1.29	)
Weighted average common shares outstanding – basic and diluted			7,497,433				2,423,370

 

Investor Contact:

Hans Vitzthum

LifeSci Advisors

Ph: 617-535-7743

[email protected]

NEWTON, MA – August 3, 2018 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical need, today announced the closing of its previously announced underwritten public offering of 2,555,555 shares of its common stock, including 333,333 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares to cover over-allotments, at a public offering price of $18.00 per share. The gross proceeds to Acer from this offering are approximately $46.0 million, before deducting underwriting discounts and commissions and estimated offering expenses.

 

Acer intends to use the net proceeds from this offering to fund its research and development efforts, to seek regulatory approval for EDSIVO™, to invest in pre-commercial activities for EDSIVO™, to advance development of ACER-001, to acquire or in-license product candidates, and for general corporate purposes, including working capital and other general and administrative purposes.

 

William Blair and Raymond James acted as joint book-running managers for the offering. Roth Capital Partners, H.C. Wainwright & Co. and CIM Securities, LLC acted as co-managers for the offering.

 

The shares of common stock described above were offered and sold by Acer pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission. The offering was made only by means of a prospectus supplement and an accompanying prospectus. Copies of the final prospectus supplement and the accompanying prospectus may be obtained from William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606; Telephone: (800) 621-0687 or by email at [email protected]; or from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, FL 33716; Telephone: (800) 248-8863 or by email at [email protected].

 

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

 

About Acer Therapeutics
Acer, headquartered in Newton, MA, is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for patients with serious rare and ultra-rare diseases with critical unmet medical need. Acer’s late-stage clinical pipeline includes two candidates for severe genetic disorders: EDSIVO™ (celiprolol) for vascular Ehlers-Danlos syndrome (vEDS), and ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate) for urea cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). There are no FDA-approved drugs for vEDS and MSUD and limited options for UCD, which collectively impact approximately 7,000 patients in the U.S. Acer’s product candidates have clinical proof-of-concept and mechanistic differentiation, and Acer intends to seek approval for them in the U.S. by using the regulatory pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) that allows an applicant to rely at least in part on third-party data for approval, which may expedite the preparation, submission, and approval of a marketing application.

 

For more information, visit www.www.acertx.com.

 

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 regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the expected use of the net proceeds from the offering, and the development and future potential of Acer’s product candidates. Acer 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, risks and uncertainties associated with market conditions, unexpected cash requirements, changes in Acer’s business plan, and the process of developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics. Acer disclaims 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 Acer makes in its filings with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q and Annual Report on Form 10-K and the Registration Statement on Form S-3 (File No. 333-208314) for the public offering. You may access these documents for no charge at http://www.sec.gov.

 

Investor Contact:
Hans Vitzthum
LifeSci Advisors
Ph: 617-535-7743
[email protected]

 

LifeSci Advisors, LLC, an affiliate of LifeSci Capital LLC, serves Acer as an investor relations, corporate communications and capital markets advisor.

NEWTON, MA – August 1, 2018 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical need, today announced the pricing of its underwritten public offering of 2,222,222 shares of its common stock at a public offering price of $18.00 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Acer, are expected to be approximately $40.0 million. In addition, Acer granted the underwriters in the offering a 30-day option to purchase up to 333,333 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. All shares in the offering will be sold by Acer.

 

Acer intends to use the net proceeds from this offering to fund its research and development efforts, to seek regulatory approval for EDSIVO™, to invest in pre-commercial activities for EDSIVO™, to advance development of ACER-001, to acquire or in-license product candidates, and for general corporate purposes, including working capital and other general and administrative purposes.

 

William Blair and Raymond James are acting as joint book-running managers for the offering. Roth Capital Partners, H.C. Wainwright & Co. and Brookline Capital Markets, a division of CIM Securities, are acting as co-managers for the offering.

 

The offering is expected to close on or about August 3, 2018, subject to customary closing conditions.

 

The shares of common stock described above are being offered and sold by Acer pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission. The offering is being made only by means of a prospectus supplement and an accompanying prospectus. Copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, from William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606; Telephone: (800) 621-0687 or by email at [email protected]; or from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, FL 33716; Telephone: (800) 248-8863 or by email at [email protected].

 

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

 

About Acer Therapeutics
Acer, headquartered in Newton, MA, is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for patients with serious rare and ultra-rare diseases with critical unmet medical need. Acer’s late-stage clinical pipeline includes two candidates for severe genetic disorders: EDSIVO™ (celiprolol) for vascular Ehlers-Danlos syndrome (vEDS), and ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate) for urea cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). There are no FDA-approved drugs for vEDS and MSUD and limited options for UCD, which collectively impact approximately 7,000 patients in the U.S. Acer’s product candidates have clinical proof-of-concept and mechanistic differentiation, and Acer intends to seek approval for them in the U.S. by using the regulatory pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) that allows an applicant to rely at least in part on third-party data for approval, which may expedite the preparation, submission, and approval of a marketing application.

 

For more information, visit www.www.acertx.com.

 

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 regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the underwritten public offering, the expected closing date of the offering, the expected use of the net proceeds from the offering, and the development and future potential of Acer’s product candidates. Acer 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, risks and uncertainties associated with market conditions, the satisfaction of customary closing conditions related to the public offering, and the process of developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics. Acer disclaims 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 Acer makes in its filings with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q and Annual Report on Form 10-K and the Registration Statement on Form S-3 (File No. 333-208314) for the public offering. You may access these documents for no charge at http://www.sec.gov.

 

Investor Contact:
Hans Vitzthum
LifeSci Advisors
Ph: 617-535-7743
[email protected]

 

LifeSci Advisors, LLC, an affiliate of LifeSci Capital LLC, serves Acer as an investor relations, corporate communications and capital markets advisor.

NEWTON, MA – July 31, 2018 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical need, today announced that it intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering. All shares being offered are to be sold by Acer. Acer intends to grant the underwriters in the offering a 30-day option to purchase an additional 15% of the shares of common stock offered in the public offering.

 

Acer intends to use the net proceeds from this offering to fund its research and development efforts, to seek regulatory approval for EDSIVO™, to invest in pre-commercial activities for EDSIVO™, to advance development of ACER-001, to acquire or in-license product candidates, and for general corporate purposes, including working capital and other general and administrative purposes.

 

William Blair and Raymond James are acting as joint book-running managers for the offering.

 

The shares of common stock described above are being offered by Acer pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission. The offering is being made only by means of a prospectus supplement and an accompanying prospectus. Copies of the preliminary prospectus supplement and the accompanying prospectus may be obtained from William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606; Telephone: (800) 621-0687 or by email at [email protected]; or from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, FL 33716; Telephone: (800) 248-8863 or by email at [email protected].

 

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

 

About Acer Therapeutics
Acer, headquartered in Newton, MA, is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for patients with serious rare and ultra-rare diseases with critical unmet medical need. Acer’s late-stage clinical pipeline includes two candidates for severe genetic disorders: EDSIVO™ (celiprolol) for vascular Ehlers-Danlos syndrome (vEDS), and ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate) for urea cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). There are no FDA-approved drugs for vEDS and MSUD and limited options for UCD, which collectively impact approximately 7,000 patients in the U.S. Acer’s product candidates have clinical proof-of-concept and mechanistic differentiation, and Acer intends to seek approval for them in the U.S. by using the regulatory pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) that allows an applicant to rely at least in part on third-party data for approval, which may expedite the preparation, submission, and approval of a marketing application.

 

For more information, visit www.www.acertx.com.

 

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 regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the underwritten public offering, the expected use of the net proceeds from the offering, and the development and future potential of Acer’s product candidates. Acer 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, risks and uncertainties associated with market conditions, the satisfaction of customary closing conditions related to the public offering, and the process of developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics. Acer disclaims 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 Acer makes in its filings with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q and Annual Report on Form 10-K and the Registration Statement on Form S-3 (File No. 333-208314) for the public offering. You may access these documents for no charge at http://www.sec.gov.

 

Investor Contact:
Hans Vitzthum
LifeSci Advisors
Ph: 617-535-7743
[email protected]

 

LifeSci Advisors, LLC, an affiliate of LifeSci Capital LLC, serves Acer as an investor relations, corporate communications and capital markets advisor.

Acer continues progression from development to potential commercialization of EDSIVO™

 

NEWTON, MA – March 7, 2018 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultrarare diseases with critical unmet medical need, today reported financial results for the quarter and fullyear ended December 31, 2017 and provided an update on the Company’s recent corporate developments.

 

“We accomplished a lot in 2017 that sets the stage nicely for us to deliver on multiple significant milestones anticipated in 2018. We believe that by going public, hiring several key executives and raising enough capital to fund our current operating requirements through the end of this year, we are now in a position to finalize the critical activities over the next few months required to submit a New Drug Application (NDA) for EDSIVO™ in vascular Ehlers-Danlos syndrome (vEDS),” said Chris Schelling, CEO and Founder of Acer. “We are also working very closely with the vEDS community to better understand their needs and to learn how we can best partner with them going forward. Collectively, we are exploring how Acer can begin supporting initiatives that help strengthen patient advocacy and establish centers of excellence, accelerate diagnosis and optimize patient care, and sponsor additional research collaborations with leading expertsin vEDS.” Mr. Schelling continued, “Beyond vEDS, we look to advance and expand our pipeline with the goal of bringing multiple products to patients with serious ultra-orphan diseases over the next several years.”

 

2017 and Recent Highlights
• Announced positive results from the pivotal clinical trial of EDSIVO™ (celiprolol) for the treatment of vEDS. Our retrospective source-verified analysis of the trial data, including the primary and secondary endpoints, confirmed the data from a previously published randomized controlled clinical study of celiprolol(1). We plan to discuss these key data during a pre-NDA meeting with the FDA in the second quarter of 2018.
• Closed merger with Opexa Therapeutics, Inc. and common stock commenced trading on the Nasdaq Capital Market in the third quarter of 2017
• Raised $28.3 million in 2017 through an underwritten public offering and the private placement of securities
• Expanded management team and independent board directors
• Ended 2017 with $15.6 million in cash and cash equivalents and no debt, which we believe is sufficient to fund our current operating and capital requirements through the end of 2018

 

Upcoming Milestones
• Potential publication of celiprolol vEDS Patient Registry data. The manuscript is currently under peer review, and if accepted, may be published by the end of the first quarter of 2018.
• Targeting a pre-NDA meeting, which may consist of one or more consults, with the FDA in the second quarter of 2018
• Anticipate submitting an NDA to the FDA for EDSIVO™ for the treatment of vEDS at the end of the first half of 2018
• Continuing pre-commercial activities for EDSIVO™
• Making additional senior-level commercial and medical affairs hires this year, as well as continuing to build out the commercial team and add other core personnel later this year

 

Financial Results for the Fourth Quarter and Full-Year 2017

 

    Cash position. Cash and cash equivalents were $15.6 million as of December 31, 2017, compared to $1.8 million as of December 31, 2016.

 

    Research and Development Expenses. Research and development expenses were $1.8 million for the three months ended December 31, 2017, compared with $1.8 million for the three months ended December 31, 2016. Research and development expenses were $8.7 million for the year ended December 31, 2017, compared with $5.3 million for the year ended December 31, 2016. Our research and development expenses continue to be primarily focused on spending for clinical development, regulatory, and manufacturing services related to EDSIVO™.

 

    General and Administrative Expenses. General and administrative expenses were $2.4 million for the three months ended December 31, 2017, compared with $0.3 million for the three months ended December 31, 2016. General and administrative expenses were $5.2 million for the year ended December 31, 2017, compared with $1.4 million for the year ended December 31, 2016. The increase in expenses is primarily due to an increase in pre-commercial activities related to EDSIVO™ and professional services costs.

 

    Net Loss. Net loss for the three months ended December 31, 2017 was $4.2 million, or $0.63 loss per share (basic and diluted), compared with a net loss of $2.1 million, or $0.87 loss per share (basic and diluted), for the three months ended December 31, 2016. Net loss for the year ended December 31, 2017 was $14.2 million, or $3.84 loss per share (basic and diluted), compared with a net loss of $6.7 million, or $2.73 loss per share (basic and diluted) for the year ended December 31, 2016.

 

For additional information, please see our Annual Report on Form 10-K filed today with the SEC.

 

About Acer Therapeutics
Acer, headquartered in Newton, MA, is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for patients with serious rare and ultra-rare diseases
with critical unmet medical need. Acer’s late-stage clinical pipeline includes two candidates for severe genetic disorders: EDSIVO™ (celiprolol) for vascular Ehlers-Danlos syndrome (vEDS), and ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate) for urea cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). There are no FDA-approved drugs for vEDS and MSUD and limited options for UCD, which collectively impact approximately 7,000 patients in the U.S. Acer’s product candidates have clinical proof-of-concept and mechanistic differentiation, and Acer intends to seek approval for them in the U.S. by using the regulatory pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) that allows an applicant to rely at least in part on third-party data for approval, which may expedite the preparation, submission, and approval of a marketing application.

 

For more information, visit www.www.acertx.com.

 

References
(1) Ong KT, et al. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010; 376: 1476–84.

 

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 regarding strategy, future operations, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for EDSIVO™ (celiprolol) and ACER-001 to safely and effectively target diseases; our ability to successfully complete regulatory submissions; and the development, expected timeline and commercial potential of any product candidates of the company. Acer 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, risks and uncertainties associated with market conditions, unexpected cash requirements, changes in Acer’s business plan, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, and the process of developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics. Acer disclaims 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

 

 

ACER THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

	Three Months Ended	Years Ended
	December 31,	December 31

	2017	2016	2017	2016
Operating expenses:
Research and development	$ 1,776,210	$ 1,798,544	$ 8,725,026	$ 5,308,662
General and administrative	2,430,677	336,703	5,223,101	1,391,182
Loss from operations	(4,206,887)	(2,135,247)	(13,948,127)	(6,699,844)
Other income (expense):
Interest income	10,029	108	14,848	282
Interest expense	(2,079)	—	(245,061)	—
Foreign currency transaction loss	(15,124)	—	(16,091)	—
Total other income (expense), net	(7,174)	108	(246,304)	282
Net loss	$(4,214,061)	$(2,135,139)	$(14,194,431)	$(6,699,562)
Net loss per share – basic and diluted	$ (0.63)	$ (0.87)	$ (3.84)	$ (2.73)
Weighted average common shares outstanding – basic and diluted	6,637,179	2,450,000	3,694,388	2,450,000

 

SELECTED BALANCE SHEET DATA:
	December 31,	December 31,
	2017	2016
Cash and cash equivalents	$ 15,644,355	$ 1,834,018
Other current assets	$ 881,887	$ 540,053
Property and equipment, net	$ 62,984	$ 6,217
Total assets	$ 24,368,741	$ 2,773,104
Total liabilities	$ 2,033,204	$ 821,439
Convertible redeemable preferred stock	$ —	$ 12,136,440
Total stockholders’ equity (deficit)	$ 22,335,537	$ (10,184,775)

Investor Contact:
Hans Vitzthum
LifeSci Advisors
Ph: 617-535-7743
[email protected]

 

NEWTON, MA, March 6, 2018 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical need, today announced that Chris Schelling, CEO and Founder, will provide a corporate overview at the 30th Annual ROTH Conference, being held March 11-14, 2018 in California.

 

Acer Therapeutics Conference Presentation Details
Date:                Tuesday, March 13
Time:                1:30 pm Pacific Time (4:30 pm Eastern Time)
Location:         The Ritz Carlton, Orange County, GREEN – SALON 3
Webcast:         https://www.acertx.com/investor-relations/events-presentations/

 

About Acer Therapeutics
Acer, headquartered in Newton, MA, is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for patients with serious rare and ultra-rare diseases with critical unmet medical need. Acer’s late-stage clinical pipeline includes two candidates for severe genetic disorders for which there are few or no FDA-approved treatments: EDSIVO™ (celiprolol) for vascular Ehlers-Danlos syndrome (vEDS), and ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate) for urea cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). There are no FDA-approved drugs for vEDS and MSUD and limited options for UCD, which collectively impact more than 7,000 patients in the United States. Acer’s product candidates have clinical proof-of-concept and mechanistic differentiation, and Acer intends to seek approval for them in the U.S. by using the regulatory pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or FFDCA, that allows an applicant to rely for approval at least in part on third-party data, which is expected to expedite the preparation, submission, and potential approval of a marketing application.

 

For more information, visit www.www.acertx.com.

 

Investor Contact:
Hans Vitzthum
LifeSci Advisors
Ph: 617-535-7743
[email protected]

Company appoints new VPs of Clinical Science, Manufacturing, and Finance and hires new Senior Director of Marketing

 

New hires support Acer’s progression from development to potential commercialization of EDSIVOTM

 

NEWTON, MA – Feb. 5, 2018 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultrarare diseases with critical unmet medical need, today announced it has appointed Terrie Kellmeyer, Ph.D., as Vice President, Clinical Science; John Klopp as Vice President, Manufacturing; and Jason Kneeland, CPA, as Vice President Finance, Controller. Also, the Company hired Kim Tharaldsen, MBA, as Senior Director, Marketing.

 

“I am very pleased to welcome Terrie, John, Jason and Kim to the management team. As we continue to successfully and rapidly advance our lead product candidate, EDSIVO™, a potential life-saving therapy for patients with vascular Ehlers-Danlos syndrome (vEDS), their experience and knowledge will be invaluable as we prepare for our NDA filing with the U.S. Food and Drug Administration and conduct precommercial activities,” said Chris Schelling, CEO and Founder of Acer. “Terrie provides us with critical expertise in the clinical/regulatory area and will drive the clinical content of our NDA submission of EDSIVO™, and will report to our CMO. John brings extensive knowledge in manufacturing from the pharmaceutical industry and will drive all our development and commercial manufacturing activities, and will report to me.”

 

“Jason is a seasoned corporate finance executive and brings nearly 20 years of experience at public revenue-generating companies. He will drive SEC reporting and accounting, and will report to our CFO,” continued Mr. Schelling. “Kim will lead our global marketing plans and will help us drive Acer’s precommercial activities. She will report to me. We plan to make additional senior-level commercial and medical affairs hires this year, as well as continue to build out the commercial team and add other core personnel later this year.”

 

About Terrie Kellmeyer, Ph.D.

Dr. Kellmeyer joined Acer as Vice President, Clinical Science in December 2017. She brings to Acer over 17 years of experience in the pharmaceutical industry spanning the areas of Clinical Development, Regulatory Affairs, Medical Writing and Medical Affairs. Over her career, Dr. Kellmeyer filed three NDAs, worked on a Brand Team preparing for product launch, and led clinical development programs. Prior to joining Acer, she served as Executive Director of Medical Writing and Scientific Communications at Intercept Pharmaceuticals where she was instrumental in leading scientific content and optimizing timelines for an NDA submission, served as a key member of the team for a positive Advisory Committee meeting, and oversaw all externally and internally facing scientific communications. Previously, Dr. Kellmeyer held positions of increasing responsibility in Clinical Development and Regulatory Affairs at Amylin Pharmaceuticals and Gen-Probe, Inc. She received a B.S. degree in Biotechnology from Rochester Institute of Technology and a Ph.D. degree in Cellular and Molecular Biology from SUNY Health Science Center at Syracuse.

 

About John Klopp

Mr. Klopp joined Acer as Vice President, Manufacturing in January 2018. He brings 15 years of experience in the biopharmaceutical industry developing small molecule drug candidates in positions ranging from research to process development to contract manufacturing management. Mr. Klopp has spent the last 11 years working on the development and commercialization of orphan drugs at BioMarin Pharmaceutical and later Ultragenyx Pharmaceutical. His expertise includes selecting and managing contract manufacturing sites producing drug substance and various oral dosage forms including associated sponsor clinical and commercial CMC regulatory strategy. Mr. Klopp received a B.S. degree in Chemistry from Pennsylvania State University and a M.S. degree in Chemistry from University of California at Berkeley.

 

About Jason Kneeland, CPA

Mr. Kneeland joined Acer as Vice President Finance, Controller in November 2017. He brings nearly 20 years of progressive experience in the corporate finance leadership of technology and related companies. Prior to joining Acer, Mr. Kneeland was VP Finance at TechTarget, Inc., a public company with 700 employees and $100M of annual revenue, where he led a team responsible for the day-to-day finance and accounting operations, as well as several key initiatives around revenue recognition and systems implementations. Prior to TechTarget, Mr. Kneeland was a Senior Manager at CFGI, where he assisted domestic and international bio-tech and technology clients with public offerings, mergers and acquisitions and other complex accounting, reporting and internal-control matters. Prior to that, Mr. Kneeland was Director of Technical Accounting of a multi-billion-dollar publicly traded retail pharmacy and pharmacy benefit management company. He has fulfilled various accounting and reporting roles with publicly traded companies in the technology industry since beginning his career in the audit practice of KPMG LLP. Mr. Kneeland is a Certified Public Accountant in the state of Massachusetts and holds a Bachelor of Science in Accounting from Johnson & Wales University.

 

About Kim Tharaldsen, MBA

Ms. Tharaldsen joined Acer as Senior Director, Marketing in January 2018. She brings to Acer over 16 years of experience managing teams and brands for companies in the pharmaceutical, diagnostic, and device markets. From product launch to end of life planning and execution, Ms. Tharaldsen has managed brands through all phases of the product lifecycle across a number of therapeutic markets including Oncology, Genetics, Neurology and Gastrointestinal disorders. In addition to a deep clinical understanding of various conditions and solutions, she brings to Acer a diverse marketing skill set that has been cultivated by experience with products that range from small niche market entrants to blockbuster, multibillion dollar drugs. Ms. Tharaldsen has contributed to the success of such companies as Eisai, Myriad Genetics, Prometheus and Hologic. She has a BS in Biology, and a MBA in Innovation and Entrepreneurship from Felician University.

 

About Acer Therapeutics

Acer, headquartered in Newton, MA, is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for patients with serious rare and ultra-rare diseases with critical unmet medical need. Acer’s late-stage clinical pipeline includes two candidates for severe genetic disorders for which there are few or no FDA-approved treatments: EDSIVO™ (celiprolol) for vascular Ehlers-Danlos syndrome (vEDS), and ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate) for urea cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). There are no FDA-approved drugs for vEDS and MSUD and limited options for UCD, which collectively impact more than 4,000 patients in the United States. Acer’s product candidates have clinical proof-of-concept and mechanistic differentiation, and Acer intends to seek approval for them in the U.S. by using the regulatory pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or FFDCA, that allows an applicant to rely for approval at least in part on third-party data, which is expected to expedite the preparation, submission, and potential approval of a marketing application.

For more information, visit www.www.acertx.com.

 

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 regarding strategy, future operations, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for EDSIVO™ (celiprolol) and ACER-001 to safely and effectively target diseases; our ability to successfully complete regulatory submissions; and the development, expected timeline and commercial potential of any product candidates of the company. Acer 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, risks and uncertainties associated with market conditions, unexpected cash requirements, changes in Acer’s business plan, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, and the process of developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics. Acer disclaims 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 Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

 

Investor Contact:

Hans Vitzthum

LifeSci Advisors

Ph: 617-535-7743

[email protected]