Item 5.02. Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On June 19, 2022, Acer Therapeutics Inc. (the "Company") appointed Tanya Hayden
as Chief Operating Officer, effective immediately. Ms. Hayden, age 42, joined
the Company in June 2021 as Vice President of Program and Strategic Alliance
Management. Prior to joining the Company, Ms. Hayden served as the Director of
Operational Excellence at Lonza, a biotechnology research company, from April
2018 to June 2021, and as Director, Value Chain Management from November 2018 to
May 2021. Prior to that, she served most recently as Vice President of
Manufacturing at Bend Research - Capsugel, a pharmaceutical manufacturing
company, from January 2014 to April 2018. Ms. Hayden received a B.S. degree in
Chemistry from Gonzaga University. Harry S. Palmin, who had been serving as the
Company's Chief Operating Officer as well as its Chief Financial Officer, will
continue to serve as the Company's Chief Financial Officer.
Pursuant to the terms of an employment agreement entered into between Ms. Hayden
and the Company, as the Company's Chief Operating Officer and an executive
officer of the Company, Ms. Hayden will receive a base salary, initially set at
an annualized amount of $325,000, and will be eligible to receive a
discretionary cash bonus of up to an annual target bonus equal to 40% of her
annual base salary, based upon the achievement of corporate objectives
established from time to time by the Company's board of directors. In addition,
Ms. Hayden was granted a non-qualified option to purchase 25,000 shares of the
Company's common stock, with a grant date of June 19, 2022. The per share
exercise price of the option is equal to the closing price of the Company's
common stock on the trading day before the grant date. The option vests over a
four-year period commencing on the date of grant, with 25% vesting on the
one-year anniversary of the grant date and the remaining 75% vesting quarterly
over the remaining three years (assuming continued service in all instances),
with a standard post-service exercise period of 90 days. In addition, the option
will accelerate and become fully vested immediately prior to a change in control
but only to the extent that the optionee remains in the service of the Company
immediately prior to such change in control. The option has a ten-year term.
In the event Ms. Hayden's employment is terminated by the Company without Cause
(as defined in the employment agreement) or due to a Constructive Termination
(as defined in the employment agreement), in each instance during the period
commencing one month prior to a Change in Control (as defined in the employment
agreement) and terminating 12 months after such Change in Control, she will be
entitled to (i) a payment, less applicable taxes and withholdings, equal to her
then-current base salary for a period of 12 months plus (ii) 1x times her annual
discretionary target bonus calculated for such period. In the event Ms. Hayden's
employment is terminated by the Company without Cause or due to a Constructive
Termination occurring outside of a Change in Control Period (as defined in the
agreement), she will be entitled to a payment, less applicable taxes and
withholdings, equal to her then-current base salary for a period of 12 months.
Ms. Hayden would receive any such payment in the form of a lump sum 60 days
following such termination of employment. In addition, whether in the context of
a Change in Control or otherwise, (x) if Ms. Hayden elects to continue her
health insurance coverage under COBRA, then the Company will reimburse her for
the same portion of her monthly premium over such 12-month period as the Company
is then paying for health insurance coverage for active employees, and (y) to
the extent not otherwise addressed by any equity-based compensation
arrangements, Ms. Hayden will be entitled to 12 months of credited vesting
beyond the employment termination date for any outstanding equity-based awards.
The severance benefits are subject to Ms. Hayden having been continuously
employed through the termination event as well as executing and delivering a
general release and waiver of claims in favor of the Company. The timing of any
payments to Ms. Hayden under the employment agreement is subject to applicable
requirements of Section 409A of the Internal Revenue Code of 1986 and the
related Treasury Regulations and may be delayed or reformed to comply with such
provisions. In the event any payment or benefit Ms. Hayden might be entitled to
receive would constitute a "parachute payment" under Section 280G of the
Internal Revenue Code, such payment or benefit will be reduced so as not to
trigger excise tax under Section 4999 of such Code, but only if such reduction
would result in a greater net payment (in view of the excise tax).
There are no family relationships between Ms. Hayden and any director, executive
officer or person nominated by the Company to become a director or executive
officer, and there are no transactions between Ms. Hayden or any of her
immediate family members, on the one hand, and the Company or any of its
subsidiaries, on the other, that would be required to be reported under
Item 404(a) of Regulation S-K.
The foregoing description of the employment agreement entered into with Ms.
Hayden, dated June 19, 2022, is qualified in its entirety by reference to the
full text of such agreement, which is filed as Exhibit 10.1 and is incorporated
herein by reference.
On June 21, 2022, the Company issued a press release entitled "Acer Therapeutics
Announces Promotion of Tanya Hayden to Chief Operating Officer," a copy of which
is attached as Exhibit 99.1 hereto and is incorporated herein by reference.
Item 8.01. Other Events
On June 21, 2022, the Company and its collaboration partner, Relief Therapeutics
Holding SA, announced that the U.S. Food and Drug Administration (the "FDA") has
issued a Complete Response Letter (the "CRL") regarding the New Drug Application
(the
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"NDA") for ACER-001 (sodium phenylbutyrate) for oral suspension for the
treatment of patients with urea cycle disorders ("UCDs"). The CRL indicates that
the FDA cannot approve the NDA in its current form. The CRL states: "[The FDA's]
field investigator could not complete inspection of [the Company's third-party
contract packaging manufacturer], because the facility was not ready for
inspection. Satisfactory inspection is required before [the NDA] may be
approved. Please notify us in writing when this facility is ready for
inspection." The FDA did not cite any other approvability issues in the CRL
pertaining to the NDA, nor request any additional clinical or pharmacokinetic
studies be conducted prior to FDA approval. The FDA did provide one comment in
the CRL (identified as "not an approvability issue") requesting additional
existing nonclinical information to be provided in the resubmission of the
NDA. The Company is actively collaborating with its third-party contract
packaging manufacturer and cooperating with the FDA to address the FDA's CRL
comments as soon as reasonably possible, and the Company currently intends to
resubmit the updated NDA for ACER-001 (sodium phenylbutyrate) for oral
suspension for the treatment of patients with UCDs in early-to-mid Q3
2022. There can be no assurance, however, that the Company will be able to meet
its intended resubmission timeline, that FDA inspection of the third-party
contract packaging manufacturer facility will be satisfactory, that such
inspection is the only impediment to FDA approval of a resubmitted NDA, that a
resubmitted NDA will otherwise be approved by the FDA, or that ACER-001 will be
approved for any indication.
On June 21, 2022, the Company issued a press release entitled "Acer Therapeutics
and Relief Therapeutics Announce Update on U.S. FDA Review of New Drug
Application (NDA) for ACER-001," a copy of which is attached as Exhibit 99.2
hereto and is incorporated herein by reference.
Item 9.01.Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No. Description
10.1 Employment Agreement between Acer Therapeutics Inc. and Tanya
Hayden dated June 19, 2022.
99.1 Press release issued by Acer Therapeutics Inc. dated June 21,
2022, entitled "Acer Therapeutics Announces Promotion of Tanya
Hayden to Chief Operating Officer."
99.2 Press release issued by Acer Therapeutics Inc. dated June 21,
2022, entitled "Acer Therapeutics and Relief Therapeutics Announce
Update on U.S. FDA Review of New Drug Application (NDA) for
ACER-001."
104 Cover page interactive data file (embedded within the inline XBRL
document).
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