Category: News

Dr. Andrews’s Appointment Supports Acer’s Progression from Development to Potential Commercialization of Therapies

 

Cambridge, MA – October 5, 2017 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 appointment of William T. Andrews, M.D., FACP as Chief Medical Officer of the Company to succeed Robert D. Steiner, M.D. in that position. “We are pleased to welcome Dr. Andrews to the executive management team, as we continue to successfully and rapidly advance our lead product candidate, EDSIVO™, a potential life-saving therapy for patients with vEDS,” said Chris Schelling, CEO and Founder of Acer. “Dr. Andrews brings tremendous experience to this role and will be instrumental in preparing our NDA submission of EDSIVO™, which we expect to accomplish in the first half of 2018, and we look forward to his guidance in the medical marketplace as we plan for our next steps. We thank Dr. Steiner for his significant contributions to Acer during a critical time in the Company’s growth.”

 

About William T. Andrews, M.D., FACP Dr. Andrews joins Acer Therapeutics as Chief Medical Officer after having worked in the biotech/pharmaceutical industry for 17 years in both Clinical Development and Medical Affairs in multiple therapeutic areas, with a focus and extensive experience in rare diseases. Dr. Andrews has significant medical marketplace and product launch experience, having served as the medical lead for six product launches, including Xopenex HFA, Brovana, Alvesco, Omnaris, Catena, and Juxtapid. Most recently, he provided strategic consulting services to rare disease companies in Clinical Development, Medical Affairs, Go-To-Market/Launch planning, and Business Development/Corporate Strategy. Previously, Dr. Andrews held senior leadership positions and positions of increasing responsibility at Aegerion Pharmaceuticals, Santhera Pharmaceuticals, Sepracor, and ClinQuest. He received his undergraduate degree in Biology from Harvard University and his M.D. degree from Yale University School of Medicine. Dr. Andrews practiced medicine for 7 years full-time and 11 years part-time in the Boston area as a board-certified Internist and an Attending Physician at Brigham and Women’s Hospital, and was on the Clinical Faculty at Harvard Medical School.

 

About Acer Therapeutics Acer, headquartered in Cambridge, 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 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 products 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 approval of a marketing application. For more information, visit 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 potential for EDSIVO™ (celiprolol) and ACER-001 to safely and effectively target diseases; the adequacy of the company’s capital to support its future operations and its ability to successfully initiate and complete clinical trials and regulatory submissions; the nature, strategy and focus of the company; 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 the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources of the company to meet its 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 Acer’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. 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 Form10-K. You may access these documents for no charge at http://www.sec.gov.

 

Investor Contact:

Hans Vitzthum

LifeSci Advisors

Ph: 212-915-2568

hans@lifescieadvisors.com

 

⦁ Company intends to file NDA for EDSIVO™ in first half of 2018     –

September 25, 2017

 

Cambridge, MA – 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 positive results from the pivotal clinical trial of EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos Syndrome (vEDS). Acer’s 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). Acer will use this pivotal clinical data to support a New Drug Application (NDA) regulatory filing in the U.S. in the first half of 2018. Ehlers-Danlos Syndrome (EDS) is a group of hereditary disorders of connective tissue. vEDS is the most severe subtype where patients suffer from life threatening arterial dissections and ruptures, as well as intestinal and uterine ruptures.  There are currently no FDA approved therapies for vEDS(2). “We have studied celiprolol for nearly two decades in vEDS patients and this is the only drug to ever demonstrate a clinical benefit in this difficult to treat patient population in a randomized, controlled clinical study,” said Pierre Boutouyrie M.D., Ph.D., co-director of the clinical pharmacology service at the Georges-Pompidou European Hospital, Greater Paris University Hospitals (AP-HP) and Principal Investigator for the published celiprolol study. “Having established celiprolol as the standard of care in France for vEDS patients, we are excited to collaborate with Acer to help bring celiprolol to U.S. patients who are suffering from this devastating, life-threatening disease.” The previously completed European study, published on October 30, 2010, in The Lancet, was stopped early having achieved statistical significance in its primary endpoints, with arterial dissection or rupture affecting 5 (20%) celiprolol patients and 14 (50%) subjects in the non-treated control group (hazard ratio [HR] 0.36; p-value 0.04). The combined primary and secondary endpoints of intestinal or uterine rupture affected 6 (24%) celiprolol patients and 17 (61%) subjects in the non-treated control group (HR 0.31; p-value 0.01). The study was conducted in 53 patients, who were randomly assigned either a twice daily treatment of celiprolol or no treatment.  Mean duration of follow-up was 47 months prior to trial halt. “We are committed to bringing EDSIVO™ to vEDS patients who currently do not have access to this treatment,” said Robert D. Steiner, M.D., Chief Medical Officer of Acer. “Our confirmation of the published celiprolol clinical data with an Acer-sponsored retrospective source verified analysis of the trial data represents a critical element of the clinical module in our NDA, which we are diligently building, along with current manufacturing, non-clinical and other components of the regulatory package.” “We continue to successfully rapidly advance our lead product candidate, EDSIVO™, a potential life-saving therapy for patients with vEDS, towards an NDA filing, which we expect to accomplish in the first half of 2018,” said Chris Schelling, CEO and Founder of Acer. “In addition to source verifying a definitive Event-Free Survival endpoint from a previously completed robust clinical study, modernizing manufacturing and assembling other components of the regulatory package, we are executing on a number of key medical affairs focused initiatives for vEDS patients.  Specifically, we are setting up Centers of Excellence to optimize patient care, and intend to develop a prospective vEDS Patient Registry and provide integrated care support programs.”

About EDSIVO™ and vEDS Ehlers-Danlos Syndrome (EDS) is a group of hereditary disorders of connective tissue. vEDS is the most severe subtype where patients suffer from life threatening arterial dissections and ruptures, as well as intestinal and uterine ruptures. The average mortality is 51 years of age. An Acer commissioned patient-finder study identified 2,200 vEDS patients in the U.S. from an analysis of commercially available patient claims data. However, experts estimate as many as 5,000 patients may be affected. There are currently no FDA-approved therapies for vEDS(2). Acer is advancing EDSIVO™ (celiprolol), a new chemical entity (NCE), for the treatment of vEDS and plans to file a NDA based on a randomized controlled clinical study of celiprolol.(1) In 2015, the U.S. Food and Drug Administration (FDA) granted EDSIVO™ orphan drug designation for the potential treatment of vEDS.

 

About Acer Therapeutics Acer, headquartered in Cambridge, MA, is a pharmaceutical company that acquires, develops and intends to commercialize 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 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 products 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 approval of a marketing application. For more information, visit 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.

(2) Pepin MG, et al. Survival is affected by mutation type and molecular mechanism in vascular Ehlers–Danlos syndrome (EDS type IV) Genet Med. 16: 881-888.

 

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 Acer’s listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of the company; the potential for EDSIVO™ (celiprolol) and ACER-001 to safely and effectively target diseases; the adequacy of the company’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; the nature, strategy and focus of the company; the development and commercial potential of any product candidates of the company; and the executive and board structure 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 the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources of the company to meet its 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 Acer’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. 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.

Investor Contact:

Hans Vitzthum

LifeSci Advisors

Ph: 212-915-2568

hans@lifescieadvisors.com

 

CAMBRIDGE, MA, September 22, 2017 – 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, Chief Executive Officer and Founder, will provide a corporate overview at the Cantor Fitzgerald Global Healthcare Conference, being held September 25-27, 2017 in New York City.

 

Acer Therapeutics Conference Presentation Details

Date: Tuesday, September 26

Time: 8:00 am Eastern Time

Location: InterContinental New York Barclay Hotel, Rockefeller Room

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

 

About Acer Therapeutics Acer, headquartered in Cambridge, MA, is a pharmaceutical company that acquires, develops and intends to commercialize 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 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 products 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 approval of a marketing application. For more information, visit www.acertx.com.

 

Contact:

Hans Vitzthum

LifeSci Advisors, LLC

212-915-2568

hans@lifesciadvisors.com

 

Acer Therapeutics and Opexa Therapeutics Close Merger and Financing

-Merger to create a pre-NDA-stage, Nasdaq-listed, pharmaceutical company focused on the development and commercialization of therapies for serious rare diseases with critical unmet medical need- -Combined company, renamed Acer Therapeutics Inc., to commence trading on Nasdaq under the symbol “ACER” on September 21- -Concurrent financing of $15.7 million from Acer investor syndicate- -Acer plans to file a NDA for its lead product, EDSIVO™, for the treatment of vascular Ehlers-Danlos Syndrome (vEDS) in the first half of 2018-

CAMBRIDGE, MA – 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, announced that today it completed the merger with Opexa Therapeutics, Inc., under which the stockholders of Acer (including investors in a financing that closed concurrently with the merger) become holders of 88.8% of combined company’s outstanding common stock, with Opexa shareholders retaining 11.2%. In conjunction with the merger, a syndicate of existing and new investors led by TVM Capital Life Sciences invested approximately $15.7 million in Acer (including through a conversion of approximately $5.7 million in outstanding convertible notes) immediately prior to closing of the merger. “Acer’s goal is to become a leading pharmaceutical company that acquires, develops and commercializes therapies for the treatment of patients with serious rare and ultra-rare diseases with critical unmet medical need,” said Chris Schelling, Chief Executive Officer and founder of Acer. “We have committed significant resources to rapidly advance our lead candidate EDSIVO™, a potential life-saving therapy for patients with vEDS. We believe that the proceeds from the concurrent financing will allow us to advance EDSIVO™ through NDA submission with the FDA in the first half of 2018. As a public company, we now look forward to engaging with a broader pool of investors as we seek to advance and expand our pipeline and make multiple products available to patients over the next several years.”

About the Merger Existing stockholders of Acer, as well as investors in Acer’s concurrent financing, received newly issued shares of Opexa common stock in connection with the merger. In the combined company: (a) Opexa shareholders retained 11.2%, (b) Acer stockholders own 63.8% (excluding shares issued to them in the concurrent financing), and (c) the investors participating in the concurrent financing own 25% (excluding shares previously held by them). The combined company has approximately 6.6 million shares of common stock outstanding, following a reverse split of 1-for-10.355527. Upon completion of the merger today, Opexa was renamed Acer Therapeutics Inc. The combined company will commence trading on the Nasdaq Capital Market under the symbol “ACER” on September 21, 2017. The directors and the sole executive officer of Opexa resigned from their positions with Opexa upon the closing of the merger, and the combined company is now under the leadership of Acer’s current executive management team with Chris Schelling serving as President and Chief Executive Officer. The board of directors of the combined company consists of 7 members: Steve Aselage, Jason Amello, Hubert Birner, John Dunn, Michelle Griffin, Luc Marengere and Mr. Schelling.

About Acer Therapeutics Acer, headquartered in Cambridge, MA, is a pharmaceutical company that acquires, develops and intends to commercialize 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 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 products have clinical proof-of-concept and mechanistic differentiation, and Acer intends to seek approval for them in the United States 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 approval of a marketing application. For more information, visit 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 Acer’s listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of the company; the potential for EDSIVO™ (celiprolol) and ACER-001 to safely and effectively target diseases; the adequacy of the company’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; the nature, strategy and focus of the company; the development and commercial potential of any product candidates of the company; and the executive and board structure 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 the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources of the company to meet its 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 Acer’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. 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.

Investor Contact:

Hans Vitzthum

LifeSci Advisors

Ph: 212-915-2568

hans@lifescieadvisors.com

Merger to create a pre-NDA-stage, NASDAQ-listed, pharmaceutical company focused on the development and commercialization of therapies for serious rare diseases with critical unmet medical need

Concurrent financing of $15.7 million from Acer investor syndicate

Acer plans to file a NDA for its lead product, EDSIVO™ (celiprolol), for the treatment of vascular Ehlers-Danlos Syndrome (vEDS) in the first half of 2018

July 3, 2017

 Cambridge, MA and THE WOODLANDS, TX – Opexa Therapeutics, Inc. (Nasdaq: OPXA) (“Opexa”) and Acer Therapeutics Inc. (“Acer”), a privately-held pharmaceutical company, today announced that they have entered into a definitive merger agreement under which the stockholders of Acer (including investors in a financing that will close concurrently with the merger) are currently estimated to become holders of approximately 88.8% of Opexa’s outstanding common stock on a pro forma basis, with current Opexa shareholders expected to own the remaining 11.2%. The proposed merger remains subject to certain conditions, including approval by Opexa’s shareholders and Acer’s stockholders.

In conjunction with the proposed merger, an investor syndicate led by TVM Capital Life Sciences and comprised of existing Acer investors and new investors has committed to invest approximately $15.7 million in Acer (including through a conversion of approximately $5.7 million in outstanding convertible notes) immediately prior to closing of the proposed merger.

“Acer’s goal is to become a leading pharmaceutical company that acquires, develops and commercializes therapies for the treatment of patients with serious rare diseases with critical unmet medical need,” said Chris Schelling, Chief Executive Officer and founder of Acer. “We have committed significant resources to rapidly advance our lead candidate EDSIVO™, a potential life-saving therapy for patients with vEDS. We believe that the proceeds from the concurrent financing will allow us to advance EDSIVO™ through NDA submission with the FDA in the first half of 2018. As a public company, we look forward to engaging with a broader pool of investors as we seek to advance and expand our pipeline and make multiple products available to patients over the next several years.”

Neil K. Warma, Opexa’s President and Chief Executive Officer added, “We have chosen to combine with Acer following an extensive review of strategic alternatives. Acer’s lead asset, EDSIVO™, could be on the market within the next two years. This factor, together with Acer’s strategic vision, pipeline, the recently secured financing and Acer’s strong management team, provides Opexa shareholders with an opportunity for growth in the value of their shares.”

About the Proposed Merger

Existing stockholders of Acer, as well as investors in Acer’s concurrent financing, will receive newly issued shares of Opexa common stock in connection with the proposed merger. On a pro forma basis for the combined company, following the closing of the proposed merger, (a) current Opexa shareholders are expected to own approximately 11.2%, (b) current Acer stockholders are expected to own approximately 63.8% (excluding shares issued to them in the concurrent financing), and (c) the investors participating in the concurrent financing are expected to own approximately 25% (excluding shares previously held by them).

The proposed merger has been unanimously approved by the boards of directors of both companies, and a majority of Acer’s stockholders have agreed to vote in favor of the transaction. The proposed merger is expected to close during the third quarter of 2017, subject to the approval of the stockholders of Acer and the shareholders of Opexa and other customary closing conditions. The merger agreement contains further details with respect to the proposed merger.  If the transaction is consummated, Opexa’s name will be changed to Acer Therapeutics Inc., and Opexa intends to apply to change its ticker symbol on the NASDAQ Capital Market to “ACER.”

The directors and the sole executive officer of Opexa will resign from their positions with Opexa upon the closing of the proposed merger, and the combined company will be under the leadership of Acer’s current executive management team with Chris Schelling serving as President and Chief Executive Officer. Following the closing of the proposed merger, the board of directors of the combined company is expected to consist of 7 members, all of whom will be designated by Acer. The corporate headquarters will be located in Cambridge, Massachusetts.

Piper Jaffray & Co. is acting as placement agent for Acer in the concurrent financing. Pillsbury Winthrop Shaw Pittman LLP served as legal counsel to Opexa and Foley Hoag LLP served as legal counsel to Acer.

 About Acer Therapeutics Inc.

 Acer, headquartered in Cambridge, MA, is a pharmaceutical company that acquires, develops and intends to commercialize therapies for patients with serious 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 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 products 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 approval of a marketing application.

For more information, visit www.acertx.com.

About Opexa Therapeutics, Inc.

 Opexa Therapeutics is a biopharmaceutical company that has historically focused on developing personalized immunotherapies with the potential to treat major illnesses, including multiple sclerosis as well as other autoimmune diseases such as neuromyelitis optica. These therapies are based on Opexa’s proprietary T-cell technology.

Safe Harbor Statement

 Additional Information about the Proposed Merger and Where to Find It

In connection with the proposed merger, Opexa and Acer intend to file relevant materials with the Securities and Exchange Commission, or the SEC, including a registration statement on Form S-4 that will contain a proxy statement / prospectus / information statement. Investors and securityholders of Opexa and Acer are urged to read these materials when they become available because they will contain important information about Opexa, Acer and the proposed merger. The proxy statement / prospectus / information statement and other relevant materials (when they become available), and any other documents filed by Opexa with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and securityholders may obtain free copies of the documents filed with the SEC by Opexa by directing a written request to: Opexa Therapeutics, Inc., 2635 Technology Forest Blvd., The Woodlands, TX 77381, Attention: Investor Relations. Investors and securityholders are urged to read the proxy statement / prospectus / information statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed merger.

This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Participants in the Solicitation

 Opexa and its directors and sole executive officer and Acer and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of Opexa in connection with the proposed transaction.  Information regarding the special interests of these directors and executive officers in the proposed merger will be included in the proxy statement / prospectus / information statement referred to above. Additional information regarding the directors and the sole executive officer of Opexa is also included in Opexa’s Annual Report on Form 10-K for the year ended December 31, 2016 and the proxy statement for Opexa’s 2016 Annual Meeting of Shareholders. These documents are available free of charge at the SEC’s web site (www.sec.gov) and from Investor Relations at Opexa at the address described above.

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 structure, timing and completion of the proposed merger or financing; Opexa’s continued listing on the NASDAQ Capital Market until closing of the proposed merger; the combined company’s listing on the NASDAQ Capital Market after closing of the proposed merger; expectations regarding the capitalization, resources and ownership structure of the combined company; the potential for Edsivo™ (celiprolol) and ACER-001 to safely and effectively target diseases; the adequacy of the combined company’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; the nature, strategy and focus of the combined company; the development and commercial potential of any product candidates of the combined company; the executive and board structure of the combined company; and expectations regarding voting by Opexa’s shareholders and Acer’s stockholders. Opexa and/or 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 securityholder approval of and the ability to consummate the proposed merger through the process being conducted by Opexa and Acer, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources of the combined company to meet its 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 Acer’s intellectual property, risks related to the drug discovery and the regulatory approval process and the impact of competitive products and technological changes.  Opexa and Acer each 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.

Acer Investor Contact:
Harry Palmin
Tel: (844) 902-6100
hpalmin@acertx.com

Opexa Investor Contact:
Neil K. Warma
Tel: (281) 881-6527
nwarma@opexatherapeutics.com

Inaugural team of experts to provide valuable insights and guidance on NDA filing of the company’s lead product, VASEBRA™ (celiprolol), for the treatment of vascular Ehlers-Danlos Syndrome, and pivotal clinical studies of ACER-001 in MSUD and UCD

CAMBRIDGE, Mass., December 20, 2016 – Acer Therapeutics Inc., a pharmaceutical company developing therapies for serious rare diseases with significant unmet medical need, today announced the formation of its Scientific Advisory Board (SAB). The five inaugural members of Acer’s SAB are:

• Gerard Berry, M.D.: Harvey Levy Chair in Metabolism; Director, Metabolism Program, Division of Genetics and Genomics, Boston Children’s Hospital; Professor of Pediatrics, Harvard Medical School Thomas Fleming, Ph.D.: Professor, Biostatistics and Professor, Statistics, University of Washington; member of the Fred Hutchinson Cancer Research Center; former Director of the Statistical Center for HIV/AIDS National Institutes of Allergy and Infectious Diseases Prevention Trial Network Marlene Haffner, M.D., M.P.H.: Founder, Haffner Associates; former Director of the Office of Orphan Products Development at the Food and Drug Administration (FDA) Brendan Lee, M.D., Ph.D.: Chairman, Molecular and Human Genetics, Baylor College of Medicine; Robert and Janice McNair Endowed Chair and Professor of Molecular and Human Genetics, Baylor College of Medicine Stuart Swiedler, M.D., Ph.D.: Biotechnology consultant and former senior executive at BioMarin Pharmaceutical

Visit www.acertx.com for full bios of SAB members. “We are excited to welcome this team of experts to our SAB, as they will provide important guidance as we progress our late-stage therapeutic candidates for serious rare diseases,” said Chris Schelling, CEO and Founder of Acer. “We look forward to working closely with our advisors as we rapidly advance our lead candidate VASEBRA™ for vascular Ehlers-Danlos Syndrome towards a New Drug Application (NDA) filing, and initiate pivotal clinical studies of ACER-001, which we are developing for Maple Syrup Urine Disease (MSUD) and Urea Cycle Disorder (UCD), devastating genetic diseases which impact amino acid and ammonia metabolism, respectively.”

About Acer Therapeutics Acer Therapeutics, headquartered in Cambridge, MA, is developing therapies with established clinical proof-of-concept for the treatment of serious, ultra-rare diseases with critical unmet medical need. The company’s late-stage clinical pipeline includes two candidates for severe genetic disorders for which there are currently no FDA-approved treatments: VASEBRA™ for vascular Ehlers-Danlos Syndrome (vEDS), and ACER-001 for Maple Syrup Urine Disease (MSUD) and Urea Cycle Disorders (UCD).

Media Contact:

Ann Stanesa

Ten Bridge Communications

617-230-0347

ann@tenbridgecommunications.com

Company obtains exclusive rights to NDA-enabling clinical data of the company’s lead product, VASEBRA™ (celiprolol), for the treatment of vascular Ehlers-Danlos Syndrome (vEDS)

CAMBRIDGE, Mass., December 13, 2016 – Acer Therapeutics Inc., a pharmaceutical company developing therapies for serious rare diseases with significant unmet medical need, today announced the signing of an agreement with the Greater Paris University Hospitals AP-HP (via its Department of Clinical Research and Development*) granting the company exclusive rights to access and use data from a randomized controlled clinical study of celiprolol.1 The company will use this pivotal clinical data to support a New Drug Application (NDA) regulatory filing for its lead product, VASEBRA™ (celiprolol), for the treatment of vascular Ehlers-Danlos Syndrome (vEDS). “We have studied celiprolol for nearly two decades in vEDS patients and this is the only drug ever to demonstrate a clinical benefit in a randomized, controlled clinical study,” said Pierre Boutouyrie M.D., Ph.D., co-director of the clinical pharmacology service at the Georges-Pompidou European Hospital AP-HP and Principal Investigator for the celiprolol study. “Having established celiprolol as a standard of care in France for vEDS patients, we are excited to partner with Acer to help bring celiprolol to members of the U.S. patient community who are suffering from this devastating, life-threatening disease.” “We are committed to bringing VASEBRA™ to vEDS patients who currently do not have access to this treatment,” said Robert D. Steiner, M.D., Chief Medical Officer of Acer. “This pivotal clinical data from AP-HP will represent a critical element of the clinical module in our NDA, which we are diligently building along with manufacturing, non-clinical and other components of the regulatory package.” “This collaboration between AP-HP and Acer is a fantastic example of academic-industry partnership,” said Chris Schelling, CEO and Founder of Acer. “The signing of this agreement marks an important corporate milestone as it will enable us to continue to rapidly advance our lead candidate VASEBRA™, a potential life-saving therapy for patients with vEDS, towards an NDA filing.”

About VASEBRA™ and Vascular Ehlers-Danlos Syndrome (vEDS) Ehlers-Danlos Syndrome (EDS) is a group of hereditary disorders of connective tissue. Vascular EDS (vEDS) is the most severe subtype where patients suffer from life threatening arterial dissections and ruptures, as well as intestinal and uterine ruptures. The average mortality is 51 years of age. There are approximately 2,000 people in the U.S. diagnosed with vEDS, though experts estimate as many as 5,000 patients may be affected. There are currently no FDA-approved therapies for vEDS.2 Acer is advancing VASEBRA™ (celiprolol), a new chemical entity (NCE), for the treatment of vEDS and plans to file an NDA based on a randomized controlled clinical study of celiprolol.1 In 2015, the U.S. Food and Drug Administration (FDA) granted VASEBRA™ orphan drug designation for the potential treatment of vEDS. *The Office for Technology Transfer & Industrial Ventures of the AP-HP’s Department of Clinical Research and Development, protects and enhances the innovations and clinical expertise of medical personnel by setting up privileged partnerships with healthcare companies. Nearly half of the patented innovations are transferred to companies all over the world and, in particular, the creation of nearly 70 young companies. The AP-HP organizes each year the APinnov Technology Transfer Meetings.

About Greater Paris university hospitals AP-HP: AP-HP (Greater Paris University Hospitals) is a European world-renowned university hospital. Its 39 hospitals treat 8 million people every year: in consultation, emergency, during scheduled or home hospitalizations. The AP-HP provides a public health service for everyone, 24 hours a day. This mission is a duty as well as a great source of pride. AP-HP is the leading employer in the Greater Paris area: 100,000 staff members – doctors, researchers, paramedical staff, administrative personnel and workers – work there.

About Acer Therapeutics Acer Therapeutics, headquartered in Cambridge, MA, is developing therapies with established clinical proof-of-concept for the treatment of serious, ultra-rare diseases with critical unmet medical need. The company’s late-stage clinical pipeline includes two candidates for severe genetic disorders for which there are currently no FDA-approved treatments: VASEBRA™ for vascular Ehlers-Danlos Syndrome (vEDS), and ACER-001 for Maple Syrup Urine Disease (MSUD) and Urea Cycle Disorders (UCD). For more information, visit 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.

2. Pepin MG, et al. Survival is affected by mutation type and molecular mechanism in vascular Ehlers–Danlos syndrome (EDS type IV) Genet Med. 16: 881-888.

Media Contact:

Ann Stanesa

Ten Bridge Communications

617-230-0347

ann@tenbridgecommunications.com

Financing will support the regulatory filing for the company’s lead product, VASEBRA™, for the treatment of Vascular Ehlers – Danlos Syndrome, as well as pivotal clinical studies for ACER-001 in MSUD and UCD

CAMBRIDGE, MA, May 9, 2016 – Acer Therapeutics Inc., a pharmaceutical company developing therapies for serious rare diseases with significant unmet medical need, today announced the company has closed its Series B round with $8.15 million in new investment. Proceeds from the financing will primarily be used to prepare a new drug application (NDA) for the company’s lead candidate, VASEBRA™ (celiprolol hydrochloride), which is being developed for the treatment of vascular Ehlers-Danlos Syndrome (vEDS), a rare, life- threatening genetic connective tissue disorder. Acer also plans to use the funds to support manufacturing and clinical development of ACER-001, a proprietary taste-masked, immediate-release formulation of sodium phenylbutyrate (NaPBA) for Maple Syrup Urine Disease (MSUD) and Urea Cycle Disorder (UCD), serious genetic diseases which impact amino acid and ammonia metabolism, respectively. With a lead investment from TVM Life Science Venture VII, Dr. Luc Marengere, Managing Partner of TVM Life Science Capital,joins the board. He joins Dr. Cynthia Lavoie, TVM General Partner, who has led investments by TVM Life Science Venture VI into the Series A and B rounds. “TVM is pleased to support an experienced team and the development of late- stage products for orphan indications with a high unmet need,” says Dr. Lavoie. “This latest investment is representative of our commitment to the team and to the patients suffering from these disorders,” adds Dr. Marengere. Investors include Bukwang Pharm. Co., which has supported the company since its Series A round. “With this latest financing, Acer is well-positioned to progress our late-stage therapeutic candidates for serious rare diseases, particularly as we rapidly advance our lead candidate VASEBRA™ for vascular Ehlers-Danlos Syndrome toward key regulatory milestones,” said Chris Schelling, CEO and founder of Acer. “We are gratified that our investors have demonstrated confidence in Acer’s approach through their participation in both rounds of the company’s financing efforts.” Both VASEBRA™ and ACER-001 received orphan drug designation from the U.S. Food and Drug Administration (FDA), which is provided to drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the U.S.

About VASEBRA™ and Vascular Ehlers-Danlos Syndrome (vEDS) Ehlers-Danlos Syndrome (EDS) is a group of hereditary disorders of connective tissue. Vascular EDS (vEDS) is the most severe subtype where patients suffer from life threatening arterial dissections and ruptures, as well as intestinal and uterine ruptures. The average mortality is 51 years of age. There are approximately 2,000 people in the U.S. diagnosed with vEDS, though experts estimate as many as 5,000 patients may be affected. There are currently no FDA-approved therapies for vEDS.1 Acer is advancing ACER-002 (celiprolol), a new chemical entity (NCE), for the treatment of vEDS and plans to file an NDA based on a randomized controlled clinical study of celiprolol.2 In 2015, the U.S. Food and Drug Administration (FDA) granted ACER-002 orphan drug designation for the potential treatment of vEDS.

About ACER-001 Maple Syrup Urine Disease (MSUD) is a rare, devastating genetic disease which prevents the proper metabolism of three essential amino acids – leucine, isoleucine and valine. There is no FDA-approved therapy for MSUD, and the condition is sub-optimally managed by a highly-restricted diet alone. Despite this diet, patients experience poor neurological outcomes and social impairment. Approximately 1,000 people suffer from MSUD in the U.S. and 3,000 are affected worldwide. A Urea Cycle Disorder (UCD) is a genetic disorder caused by a mutation that results in a deficiency of one of the six enzymes in the urea cycle. These enzymes are responsible for removing ammonia from the blood stream. In UCDs, nitrogen accumulates in the form of ammonia, a highly toxic substance, resulting in hyperammonemia (elevated blood ammonia).Ammonia then reaches the brain through the blood, where it can cause irreversible brain damage, coma and/or death. Approximately 2,000 patients have been diagnosed with a UCD in the U.S. Acer is planning to initiate pivotal clinical studies of ACER-001 for the treatment of MSUD and UCD. In 2014, the U.S. Food and Drug Administration (FDA) granted ACER -001 orphan drug designation for the potential treatment of MSUD.

About Acer Therapeutics

Acer Therapeutics, headquartered in Cambridge, MA, is developing therapies with established clinical proof-of-concept for the treatment of serious, ultra-rare diseases with critical unmet medical need. The company’s late-stage clinical pipeline includes two candidates for severe genetic disorders for which there are currently no FDA-approved treatments : ACER-002 for vascular Ehlers-Danlos Syndrome (vEDS), and ACER-001 for Maple Syrup Urine Disease (MSUD). To date, Acer has raised $12.25 million in Series A and Series B rounds.

For more information, visit www.acertx.com.

References:

1.Pepin  MG,  et  al. Survival  is  affected  by  mutation  type  and  molecular  mechanism  in vascular Ehlers–Danlos syndrome (EDS type IV) Genet Med. 16: 881-888.

2.Ong  KT,  et  al.  Effect  of  celiprolol  on  prevention  of  cardiovascular  events  in  vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoint trial.

Lancet.2010; 376: 1476–84.

Media Contact:

Ann Stanesa

Ten Bridge Communications

617-230-0347

ann@tenbridgecommunicatio

Acer Therapeutics Inc., a pharmaceutical company developing therapies for serious rare diseases with significant unmet medical need, appointed Robert Steiner, M.D. to Chief Medical Officer. In this role, Dr. Steiner will be responsible for driving strategy for and leading the clinical development of Acer’s two lead programs, ACER-001 and ACER-002.

“Bob brings a unique perspective to his role as Chief Medical Officer at Acer, with an extensive experience in clinical practice, research and healthcare business administration,” said Chris Schelling, CEO and Founder of Acer Therapeutics.

“We are thrilled to have him join the company, as he will play a key role in moving our programs for ACER-001 and ACER-002 through clinical development to address the critical unmet need for the rare disease patient populations we aim to serve, and that he knows so well.”

In addition to his role within Acer, Dr. Steiner is a Professor at the University of Wisconsin School of Medicine and Public Health. Most recently, he served as executive director of Marshfield Clinic Research Foundation (MCRF), Chief Scientific Officer for Marshfield Clinic, and Executive Associate Director, University of Wisconsin Institute for Clinical and Translational Research (ICTR). At MCRF, he directed a research institute with 200 employees, 30 full-time scientists, 125 clinician-investigators, a $25 million annual budget, and a sizable endowment. In this role, he worked closely with the Marshfield Clinic Institute for Quality and Patient Safety, the development team, and the technology transfer group. In addition, he has more than 20 years experience collaborating with and consulting with industry primarily related to orphan/rare disease diagnostics and drug development.  Dr. Steiner was formerly Credit Unions for Kids Professor of Pediatric Research, Professor of Pediatrics and Molecular & Medical Genetics, and Vice Chair for research in pediatrics at Doernbecher Children’s Hospital and the Institute for Developmental Disabilities, Oregon Health & Science University (OHSU) in Portland, Oregon where he retains an affiliate professorship.  He also led the division of metabolism, department of Pediatrics at OHSU for over a decade. He earned a B.S. with honors from the University of Wisconsin, followed by an M.D. from the University of Wisconsin School of Medicine. He subsequently completed residency in pediatrics at Cincinnati Children’s Hospital Medical Center and fellowship in medical genetics at the University of Washington and Seattle Children’s Hospital. Dr. Steiner is board certified in pediatrics, clinical genetics, and clinical biochemical genetics.

 

Acer Therapeutics Receives Patents in the U.S. and EU for the use of Sodium Phenylbutyrate (NaPB) and Prodrugs for the Potential to Treat Maple Syrup Urine Disease (MSUD)

The United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO) have issued U.S. Patent 9,078,865 and EU patent 2,456,304, respectively, covering ACER-001, a proprietary taste-masked, immediate-release formulation of sodium phenylbutyrate (NaPB), for treating Maple Syrup Urine Disease (MSUD). MSUD is a rare, devastating genetic disease which prevents the proper metabolism of three essential, branched-chain amino acids (BCAAs) – leucine, isoleucine and valine. Acer filed the recently issued patents in 2010, which would expire in 2030 without extensions.

There is no FDA-approved therapy for MSUD, and the condition is sub-optimally managed via a BCAA-restricted diet alone. Despite this diet, patients still experience poor neurological outcomes and social impairment. Approximately 1,000 people suffer from MSUD in the U.S. and 3,000 are affected worldwide.

ACER-001 was granted orphan drug designation by the FDA in 2014. This designation, along with the recently issued patents, strengthens the exclusive position of Acer in advancing ACER-001 as the first potential therapy for the treatment of MSUD.