UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 19, 2019
Regulus Therapeutics Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-35670
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26-4738379
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(State
of incorporation)
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(Commission
File No.)
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(IRS Employer
Identification No.)
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10628 Science Center Drive, Suite 225
San Diego, CA
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92121
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code: (858)
202-6300
10628 Science Center Drive, Suite 100
San Diego, CA 92121
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form
8-K
filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions (see General Instruction A.2. below):
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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17
CFR
240.14a-12)
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☐
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $0.001 per
share
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RGLS
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The Nasdaq Stock Market LLC
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of
1933 (§230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company ☐
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act. ☐
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Item 5.02
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Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers;
Compensatory Arrangements of Certain Officers.
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(b)
On July 19, 2019, Daniel R. Chevallard, Chief Financial Officer of Regulus Therapeutics Inc. (the “Company”), tendered his resignation to the
Company in order to pursue other career opportunities, effective July 26, 2019.
(c)
On July 21, 2019, the Company’s Board of Directors (the “Board”) appointed Joseph Hagan, the Company’s President and Chief Executive
Officer, as the interim principal financial officer and Daniel Penksa, the Company’s Controller, as the principal accounting officer, each effective on July 26, 2019.
Mr. Hagan, age 50, has served as the Company’s President and Chief Executive Officer and principal executive officer since May 2017. Mr. Hagan
previously served as the Company’s Chief Operating Officer, principal financial officer and principal accounting officer from January 2016 to May 2017. From June 2011 through December 2015, Mr. Hagan served as the Executive Vice President,
Chief Financial Officer and Chief Business Officer of Orexigen Therapeutics, Inc. From May 2009 to June 2011, Mr. Hagan served as Orexigen’s Senior Vice President, Corporate Development, Strategy and Communications. From September 1998 to
April 2008, Mr. Hagan served as Managing Director of Amgen Ventures. Prior to starting the Amgen Ventures Fund, Mr. Hagan served as Head of corporate development for Amgen Inc. Before joining Amgen, Mr. Hagan spent five years in the
bioengineering labs at Genzyme and Advanced Tissue Sciences. Mr. Hagan has served on the board of directors of Zosano Pharma, a publicly traded biotechnology company, since May 2015 and on the board of Aurinia Pharmaceuticals, Inc., since
February 2018. He received an M.B.A. from Northeastern University and a B.S. in Physiology and Neuroscience from the University of California, San Diego.
Mr. Penksa, age 34, has been employed with the Company since June 2015, joining the Company as its Manager of SEC Reporting and SOX Compliance, was
promoted to Assistant Controller in May 2018, and was most recently promoted to the role of Controller in July 2019. Prior to his employment with the Company, Mr. Penksa was a Senior Audit Associate with Grant Thornton, LLP from October 2011 to
June 2015. Mr. Penksa received a BSBA in Finance, a BSBA in Accounting and an MS in Accounting, all from the University of Nevada, Las Vegas, and is a Certified Public Accountant.
(e)
On July 21, 2019, the Board approved the Company’s
entry into a consulting agreement with Daniel R. Chevallard, to be effective on July 26, 2019. Pursuant to the consulting agreement, Mr. Chevallard has agreed to assist the Company with finance and accounting matters as reasonably
requested by the Company for a period of up to ninety (90) days. Under the terms of the consulting arrangement, Mr. Chevallard will receive $300 per hour for his services.
On July 23, 2019, the Company issued a press release announcing certain updates relating to RGLS4326. A copy of the press release is attached as Exhibit
99.1 to this report.
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Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits.
Forward-Looking Statements
Statements contained in this report and the attached press release regarding matters that are not historical facts are “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the completion of preclinical and clinical activities concerning the RGLS4326 program, including statements regarding
the sufficiency of the data resulting from the ongoing or planned preclinical studies required to recommence the clinical studies and the timing of preclinical and clinical activities. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,”
“will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions
that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include,
without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs, and feedback from the
U.S. Food and Drug Administration. These and other risks are described in additional detail in the Company’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this report and the
attached press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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Regulus Therapeutics Inc.
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Date: July 25, 2019
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By:
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/s/ Joseph Hagan
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Joseph Hagan
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President and Chief Executive Officer
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Exhibit 99.1
Regulus Therapeutics Announces RGLS4326 Program Update
Data Requirements Defined To Reinitiate Multiple Ascending Dose And Chronic Dose Studies
With RGLS4326
Single Ascending Dose Studies With RGLS4326 May Be Pursued
LA JOLLA, Calif., July 23, 2019
–
Regulus Therapeutics Inc
. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, today announced a program update for RGLS4326 for the treatment of Autosomal
Dominant Polycystic Kidney Disease (ADPKD). The Company has been working with the United States Food and Drug Administration (FDA) since July 2018, when Regulus voluntarily paused the Phase 1 clinical program due to unexpected findings in the mouse
chronic toxicity study being run in parallel with the Phase 1 program. In consultation with FDA, Regulus provided the interim analyses from a new mouse chronic toxicity study and the
non-human
primate (NHP)
chronic toxicity study and supporting information to enable
re-initiation
of the Multiple Ascending Dose (MAD) study. After review of the requested submission, FDA notified the Company of additional
nonclinical data requirements and placed the IND on a partial clinical hold, formalizing the specific requirements to reinitiate the MAD study and further proceed into chronic dosing in ADPKD patients.
The additional data requirements have been outlined in two parts. In order to resume the MAD study, FDA has requested the final reports from
the chronic toxicity studies in both mice and NHP and satisfactory related analyses to ensure subjects can be safely dosed. Additional data and analyses from new nonclinical studies, planned to be generated over the next several quarters, will be
required for chronic dosing, and may also be used to support the resumption of the MAD study.
Regulus is allowed to proceed with
additional Single Ascending Dose (SAD) clinical studies as part of the process to gather additional supporting information to guide the future development of the program. The Company previously announced that it had completed both the SAD study in
healthy volunteers up to the planned highest dose, as well as the first dose level of the MAD study in healthy volunteers. Clinical data generated to date showed that RGLS4326 administration was generally well-tolerated with no serious adverse
events for all doses tested.
“We appreciate the productive dialog with FDA throughout this process,” stated Jay Hagan, CEO of
Regulus. “They have provided clear requirements that we believe we can address with data anticipated in the next several months from ongoing studies, augmented by data to be generated from additional studies that we expect to be completed early
next year.”
About ADPKD
ADPKD, caused by the mutations in the PKD1 or PKD2 genes, is among the most common human monogenic disorders and a leading cause of
end-stage
renal disease. The disease is characterized by the development of multiple fluid filled cysts primarily in the kidneys, and to a lesser extent in the liver and other organs. Excessive kidney cyst cell
proliferation, a central pathological feature, ultimately leads to
end-stage
renal disease in approximately 50% of ADPKD patients by age 60.
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About RGLS4326
RGLS4326 is a novel oligonucleotide designed to inhibit
miR-17
and designed to preferentially target
the kidney. Preclinical studies with RGLS4326 have demonstrated direct regulation of PKD1 and PKD2 in human ADPKD cyst cells, a reduction in kidney cyst formation, improved kidney weight/body weight ratio, decreased cyst cell proliferation, and
preserved kidney function in mouse models of ADPKD.
About Regulus
Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical company focused on the discovery and development of innovative medicines
targeting microRNAs. Regulus maintains its corporate headquarters in La Jolla, CA.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the completion of preclinical and clinical activities concerning the RGLS4326 program, including statements regarding the sufficiency of the
data resulting from the ongoing or planned preclinical studies required to recommence the clinical studies and the timing of preclinical and clinical activities. Because such statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,”
“potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus’ current expectations and involve assumptions that may never materialize or may prove to
be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the
process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs, and feedback from the FDA. These and other risks are described
in additional detail in Regulus’ filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to
update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Relations Contact:
Dan Chevallard
Chief
Financial Officer
858-202-6376
dchevallard@regulusrx.com
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