SAN DIEGO, March 10, 2022 /PRNewswire/ -- Regulus
Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company
focused on the discovery and development of innovative medicines
targeting microRNAs (the "Company" or "Regulus"), today announced
its financial results for the fourth quarter and year ended
December 31, 2021 and provided a
corporate update.
"Last year was a transformational year for Regulus with the
accomplishments in our ADPKD program including clinical validation
of the target and the prioritization and advancement of our next
generation compound RGLS8429," commented Jay Hagan, CEO of Regulus Therapeutics. "We are
on track with an IND filing and initiation of our Phase 1 clinical
study and with the recent equity financing we believe the Company
is poised and capitalized to deliver on upcoming milestones."
Program Updates
RGLS8429 for ADPKD: In January
2022, the Company announced the successful completion of a
pre-investigational new drug (Pre-IND) meeting with the U.S.
Food and Drug Administration (FDA). The FDA provided overall
agreement with the trial design and length of the Phase 1 study.
Based on this feedback, the company is on track to submit an IND
application in the second quarter of 2022 to obtain clearance for
the initiation of the Phase 1 clinical trial. The Company
anticipates reporting top-line data from the healthy volunteer
portion of the study in the second half of 2022, and top-line
biomarker data in the first cohort of RGLS8429-treated patients
with ADPKD in the first half of 2023.
Lademirsen (RG-012) for Alport syndrome: In February 2022, the Company announced completion
of enrollment in the Phase 2 HERA clinical study evaluating
lademirsen for the treatment of adult patients with Alport Syndrome
under the Company's Collaboration and License Agreement with
Sanofi. Final data is expected in the first half of 2023 and
if successful could provide further validation of the Company's
platform technology designed to address genetic kidney diseases and
earn the Company a $25 million
milestone, furthering the cash runway into 2024.
Corporate Highlights
Closed $34.6 Million Private
Placement: In November 2021, the
Company announced the closing of a private placement of equity. The
financing was led by the Federated Hermes Kaufmann Funds and New
Enterprise Associates (NEA), with participation from other new and
existing investors. The Company received gross proceeds of
approximately $34.6 million from the sale of 58,923,352
shares of the Company's common stock ("Common Stock") at a purchase
price of $0.36 per share. In addition, the Company
sold 3,725,720 shares of non-voting Class A-4 convertible preferred
stock, in lieu of shares of Common Stock, at a price
of $3.60 per share. Each share of non-voting Class
A-4 convertible preferred stock is convertible into 10 shares of
Common Stock, subject to certain beneficial ownership conversion
limitations. Net proceeds from the transaction will be used for
non-clinical and clinical development activities for the Company's
product candidates and general corporate purposes. SVB Leerink
acted as the lead placement agent for the financing and H.C.
Wainwright and Co. acted as co-placement agent.
Expanded Team: In December
2021, the Company announced the appointment of Mohammad Ahmadian, Ph.D., as Vice President,
Chemistry and Pharmaceutical Development. Dr. Ahmadian has
worked for various life sciences companies in research and
managerial capacities. Most recently, he was Vice President &
Resident Director of Kinovate Life Sciences, Inc.
Financial Results
Cash Position: As of December
31, 2021, Regulus had $60.4
million in cash and cash equivalents.
Research and Development (R&D)
Expenses: Research and development expenses were
$4.4 million and $17.8 million for the fourth quarter and year
ended December 31, 2021,
respectively, compared to $4.0
million and $15.3 million for
the same periods in 2020, respectively. These amounts reflect
internal and external costs associated with advancing our clinical
and preclinical pipeline.
General and Administrative (G&A)
Expenses: General and administrative expenses were
$2.6 million and $10.0 million for the fourth quarter and
year ended December 31, 2021,
respectively, compared to $2.1
million and $8.8 million for the
same periods in 2020, respectively. These amounts reflect
personnel-related and ongoing general business operating costs.
Net Loss: Net loss was $7.1
million, or $0.07 per share
(basic and diluted), and $27.8
million, or $0.32 per share (basic and diluted),
for the fourth quarter and year ended December 31, 2021, respectively, compared to
$1.3 million, or $0.03 per share
(basic and diluted), and $15.7 million, or $0.45 per
share (basic and diluted), respectively, for the same periods in
2020.
Conference Call and Webcast Information:
The Company
will host a conference call and live audio webcast today
at 5:00 p.m. ET to discuss its fourth quarter and year end
2021 financial results and corporate update. To access the
call, please dial (877) 257-8599 (domestic) or (970) 315-0459
(international) and refer to conference ID 3786683. To access
the telephone replay of the call, dial (855) 859-2056 (domestic) or
(404) 537-3406 (international), passcode ID 3786683. The
webcast and telephone replay will be archived on the Company's
website at www.regulusrx.com following the call.
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.
About RGLS8429
RGLS8429 is a novel, next generation oligonucleotide designed to
inhibit miR-17 and to preferentially target the kidney.
Administration of RGLS8429 has shown robust data in preclinical
models, where clear improvements in kidney function, size, and
other measures of disease severity, as well as a superior
pharmacologic profile have been demonstrated. Regulus has
nominated RGLS8429 as a clinical candidate for the treatment 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 has leveraged
its oligonucleotide drug discovery and development expertise to
develop a pipeline complemented by a rich intellectual property
estate in the microRNA field. Regulus maintains its corporate
headquarters in San Diego, CA.
Forward-Looking Statements
Statements contained in this presentation 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 Company's RGLS8429
program, including the potential sufficiency of the preclinical
data required to support clinical studies, the expected timing for
submitting an IND and initiating a Phase 1 clinical study, the
expected timing for reporting topline data, and the timing and
future occurrence of clinical data concerning lademirsen. 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 the risk additional toxicology data may be negative. In
addition, while Regulus expects the COVID-19 pandemic to adversely
affect its business operations and financial results, the extent of
the impact on Regulus' ability to achieve its preclinical and
clinical development objectives and the value of and market for its
common stock, will depend on future developments that are highly
uncertain and cannot be predicted with confidence at this time,
such as the ultimate duration of the pandemic, travel restrictions,
quarantines, social distancing and business closure requirements in
the U.S. and in other countries, and the effectiveness of actions
taken globally to contain and treat the disease. These and other
risks are described in additional detail in Regulus' filings with
the Securities and Exchange Commission, including under the "Risk
Factors" heading of Regulus most recently quarterly report on Form
10-Q. 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.
Regulus
Therapeutics Inc.
Selected Financial
Information
Condensed
Statement of Operations
(In thousands,
except share and per share data)
|
|
|
|
Three months
ended
December
31,
|
|
Year
ended
December
31,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue under
strategic
alliances
|
|
$
|
0
|
|
$
|
5,000
|
|
$
|
0
|
|
$
|
10,006
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
4,409
|
|
3,951
|
|
17,794
|
|
15,347
|
General and
administrative
|
|
2,551
|
|
2,078
|
|
10,022
|
|
8,814
|
Total operating
expenses
|
|
6,960
|
|
6,029
|
|
27,816
|
|
24,161
|
Loss from
operations
|
|
(6,960)
|
|
(1,029)
|
|
(27,816)
|
|
(14,155)
|
Other (expense)
income, net
|
|
(173)
|
|
(286)
|
|
9
|
|
(1,575)
|
Loss before income
taxes
|
|
(7,133)
|
|
(1,315)
|
|
(27,807)
|
|
(15,730)
|
Income tax
expense
|
|
|
0
|
|
|
(7)
|
|
(1)
|
|
0
|
Net loss
|
|
$
|
(7,133)
|
|
$
|
(1,322)
|
|
$
|
(27,808)
|
|
$
|
(15,730)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.07)
|
|
$
|
(0.03)
|
|
$
|
(0.32)
|
|
$
|
(0.45)
|
Weighted average
shares used to compute basic and diluted net loss per
share:
|
|
|
106,902,912
|
|
|
47,731,012
|
|
|
85,704,535
|
|
|
34,977,378
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
2021
|
|
December 31,
2020
|
|
|
|
Cash and cash
equivalents
|
|
$
|
60,383
|
|
$
|
31,087
|
Total
assets
|
|
68,454
|
|
37,604
|
Term loan, less debt
issuance costs
|
|
4,673
|
|
4,652
|
Stockholders'
equity
|
|
|
54,958
|
|
|
26,026
|
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SOURCE Regulus Therapeutics Inc.