NEWTON, MA –
August 27, 2019 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical
company focused on the acquisition, development and commercialization of
therapies for serious rare and life-threatening diseases with significant unmet
medical needs, today announced that Acer’s management team will provide a
corporate overview at the 21st Annual H.C. Wainwright Global
Investment Conference being held at the Lotte New York Palace Hotel in New York
City on Tuesday, September 10, 2019.
21st Annual H.C. Wainwright
Global Investment Conference Details
Acer is a pharmaceutical company
focused on the acquisition, development and commercialization of therapies for
serious rare and life-threatening diseases with significant unmet medical
needs. Acer’s pipeline includes three clinical-stage candidates: EDSIVO™ (celiprolol)
for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a
confirmed type III collagen (COL3A1) mutation; ACER-001 (a fully taste-masked,
immediate release formulation of sodium phenylbutyrate) for the treatment of
various inborn errors of metabolism, including urea cycle disorders (UCDs) and
Maple Syrup Urine Disease (MSUD); and osanetant for the treatment of induced
Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely
contraindicated. Acer’s product candidates are believed to present a
comparatively de-risked profile, having one or more of a favorable safety
profile, clinical proof-of-concept data, mechanistic differentiation and/or
accelerated paths for development through specific programs and procedures established
by the FDA.
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 actions or 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 capital resources; the anticipated future reduction in operating
and cash conservation benefits associated with our corporate restructuring
initiative; the potential for EDSIVO™ (celiprolol), ACER-001 and osanetant to
safely and effectively treat diseases and to be approved for marketing; the
commercial or market opportunity of any of our product candidates 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; our progress toward possible approval for EDSIVO™; the
ability to protect our intellectual property rights; our strategy and business
focus; 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, our ability to reduce our operating expenses and conserve cash on a
net basis as a result of our prior or any future corporate restructuring
initiative, 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, the
substantial costs and diversion of management’s attention and resources which
could result from securities class action litiation, risks related to the drug
development and the regulatory approval process, including the timing of
regulatory actions, 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.
NEWTON, MA –
August 13, 2019 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical
company focused on the acquisition, development and commercialization of
therapies for serious rare and life-threatening diseases with significant unmet
medical needs, today reported financial results for the second quarter ended June
30, 2019 and provided an update on the Company’s recent corporate developments.
“Following receipt of the previously announced EDSIVO™ Complete Response Letter, we plan to meet with the FDA to better understand its views. We are continuing to evaluate paths forward for EDSIVO™ on behalf of the COL3A1+ vascular Ehlers-Danlos syndrome patients, who currently have no approved treatment options,” said Chris Schelling, CEO and Founder of Acer. “As we continue to proactively manage our cash, we have taken prudent steps, including a significant restructuring of the Company, to allow for the continued advancement of our pipeline products through the end of 2020. We look forward to reporting progress on a number of important milestones throughout the second half of 2019 and into 2020.”
Second Quarter 2019 and Recent Events
ACER-001 Investigational New Drug (IND) application cleared for
initiation of pivotal bioequivalence bridging and taste assessment trials of
ACER-001 compared to sodium phenylbutyrate
Disclosed
osanetant clinical development plan for patients with induced Vasomotor Symptoms
(iVMS), which may include patients receving tamoxifen treatment for breast
cancer and/or leuprolide treatment for prostate cancer and/or women who elect
to have prophylactic bilateral oophorectomy (surgical removal of ovaries) where
Hormone Replacement Therapy (HRT) is likely contraindicated
Ended the
second quarter with $23.5 million in cash and cash equivalents, which the
Company believes
will be sufficient to fund its current operating and capital requirements
through the end of 2020
Upcoming Milestones
EDSIVO™
Conduct
Type A meeting with FDA in Q3 2019 to discuss EDSIVO™ Complete Response Letter
ACER-001:
Conduct Type C meeting with FDA in 2H 2019 to discuss ACER-001 development
plans
Initiate ACER-001 pivotal bioequivalence bridging and taste assessment
trials in Q4 2019
Submit ACER-001 New Drug Application (NDA) for UCD patients in mid-2020,
assuming successful outcomes in bridging trials and sufficient drug product
stability data to enable NDA filing
Osanetant:
Submit osanetant IND in Q4 2019
Initiate Phase 1/2 trial in mid-2020 evaluating osanetant in patients with iVMS, which may include
patients receving tamoxifen treatment for breast cancer and/or leuprolide
treatment for prostate cancer and/or women who elect to have prophylactic
bilateral oophorectomy (surgical removal of ovaries) where
Hormone Replacement Therapy (HRT) is likely contraindicated
Financial
Results for the Second Quarter 2019
In order to reduce
operating expenses and conserve cash resources, the Company implemented a
corporate restructuring initiative on June 28, 2019 which included a reduction
of approximately 60% of its full-time workforce of 48 employees and a halt of
pre-commercial activities for EDSIVO™. The Company implemented the
restructuring in light of the Complete Response Letter received from the FDA after
market close on June 24, 2019 regarding its NDA for EDSIVO™ for the treatment
of vascular Ehlers-Danlos syndrome (vEDS). The Company recorded a one-time severance-related charge of approximately $1.5
million associated with the workforce reduction in the second quarter of
2019.
Cash
position. Cash and cash equivalents were $23.5 million as of June 30, 2019,
compared to $41.7 million as of December 31, 2018. The Company believes its
cash position will be sufficient to fund its current operating and capital
requirements through the end of 2020.
Research
and Development Expenses. Research and development expenses were $4.2 million during the three
months ended June 30, 2019, compared to $2.7 million during the three months
ended June 30, 2018. This increase of $1.5 million was principally due to a $1.1 million increase in employee-related expenses,
which included expense of $0.5 million related to the restructuring. The
remaining increase in research and development expenses was primarily due to
increases in expenses related to manufacturing services, partially offset by
decreases in spending for research services. Research and development expenses for the
three months ended June 30, 2019 were primarily comprised of approximately $3.0
million related to EDSIVO™ and approximately $1.0 million related to ACER-001.
General
and Administrative Expenses. General and administrative expenses were $6.9
million for the three months ended June 30, 2019 compared to $2.2 million for
the three months ended June 30, 2018. The increase of $4.7 million was
primarily due to a $2.7 million increase
in employee-related expenses, which included expense of $1.0 million related to
the restructuring. The remaining increase in general and administrative
expenses was primarily due to increases in expenses related to pre-commercial
activities and professional services.
Net
Loss.
Net loss for the three months ended June 30, 2019 was $11.0 million, or $1.09
loss per share (basic and diluted), compared to a net loss of $4.8 million, or
$0.64 loss per share (basic and diluted), for the three months ended June 30,
2018. The increase in loss per share (basic and diluted) was driven largely by increases
in employee-related expenses, which included expenses related to the
restructuring, as well as increases in expenses related to pre-commercial
activities, expenses related professional services, and expenses related to
manufacturing services, partially offset by a decrease in spending for contract
research and by an increase in the number of shares outstanding at June 30,
2019 as compared to June 30, 2018.
For additional
information, please see Acer’s Quarterly Report on Form 10-Q filed today with
the SEC.
About
Acer Therapeutics
Acer is a pharmaceutical company
focused on the acquisition, development and commercialization of therapies for
serious rare and life-threatening diseases with significant unmet medical
needs. Acer’s pipeline includes three clinical-stage candidates: EDSIVO™
(celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in
patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a
fully taste-masked, immediate release formulation of sodium phenylbutyrate) for
the treatment of various inborn errors of metabolism, including urea cycle
disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant for the
treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy
(HRT) is likely contraindicated. Acer’s product candidates are believed to
present a comparatively de-risked profile, having one or more of a favorable
safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated
paths for development through specific programs and procedures established by
the FDA.
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 actions or 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 capital resources; the anticipated future reduction in operating and cash conservation benefits associated with our corporate restructuring initiative; the potential for EDSIVO™ (celiprolol), ACER-001 and osanetant to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates 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; our progress toward possible approval for EDSIVO™; the ability to protect our intellectual property rights; our strategy and business focus; 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, our ability to reduce our operating expenses and conserve cash on a net basis as a result of our prior or any future corporate restructuring initiative, 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, the substantial costs and diversion of management’s attention and resources which could result from securities class action litigation, risks related to the drug development and the regulatory approval process, including the timing of regulatory actions, 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.
NEWTON, MA –
August 1, 2019 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical
company focused on the acquisition, development and commercialization of
therapies for serious rare and life-threatening diseases with significant unmet
medical needs, today announced that Acer’s management team will provide a
corporate overview at the 2019 Wedbush PacGrow Healthcare Conference being held
at the Parker New York Hotel in New York City on Wednesday, August 14, 2019. 2019 Wedbush PacGrow Healthcare Conference Details
Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes three clinical-stage candidates: ACER-001 (a fully taste-masked, immediate release formulation of sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); osanetant for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is contraindicated; and EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation. Acer’s product candidates are believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA.
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 actions or 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 capital resources; the anticipated future reduction in operating
and cash conservation benefits associated with our corporate restructuring
initiative; the potential for EDSIVO™ (celiprolol), ACER-001 and osanetant to
safely and effectively treat diseases and to be approved for marketing; the
commercial or market opportunity of any of our product candidates 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; our progress toward possible approval for EDSIVO™; the
ability to protect our intellectual property rights; our strategy and business
focus; 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, our
ability to reduce our operating expenses and conserve cash on a net basis as a
result of our prior or any future corporate restructuring initiative, 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, the substantial
costs and diversion of management’s attention and resources which could result
from securities class action litiation, risks related to the drug development
and the regulatory approval process, including the timing of regulatory
actions, 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.
