Sienna Biopharmaceuticals, Inc. (Nasdaq:SNNA), a clinical-stage
biopharmaceutical company, today reported the Company’s financial
results for the fourth quarter and full year of 2018.
“We are pleased to report the results of our
2018 fourth quarter and full year and contemplate the possibilities
in 2019, particularly in light of our streamlined focus on
strategic priorities and successful equity raise,” said Frederick
C. Beddingfield III, M.D., Ph.D., President and Chief Executive
Officer of Sienna. “Our drive to bring unconventional scientific
innovations to patients whose lives remain burdened by their
disease without compromising safety has unlocked a pipeline of
selective kinase inhibitors that target select pathways in specific
tissues to treat a variety of chronic inflammatory and immunologic
conditions with minimal to no systemic exposure. We are poised to
begin Phase 3 enrollment for SNA-120 (pegcantratinib) later this
year as a potential first-in-class, non-steroidal treatment for
psoriasis and the associated pruritus. Additionally, we continue to
see potential in SNA-125, our tissue-targeted JAK3/TrkA dual kinase
inhibitor, for other inflammatory disorders of the skin, as well
the gastrointestinal tract, the eye and the lung. Indeed, with
additional funding through a business-development transaction or
other means, we would plan to move SNA-125 forward with a Phase 2
trial in atopic dermatitis, as well as with a proof-of-concept
study in ulcerative colitis, where the need for gut-restricted
drugs with low systemic exposure is high. We are actively seeking a
strategic partner for SNA-001, with positive results now in hand
that provide a potential path to regulatory clearance. Our future
is bright, and we look forward to translating our scientific
aptitude and curiosity into new possibilities and positivity for
patients who continue to suffer from autoimmune and inflammatory
disorders across multiple therapeutic areas.”
Business Highlights
In February 2019, Sienna closed a follow-on
public offering of 9,200,000 shares of common stock at a public
offering price of $2.50 per share, which included the exercise in
full by the underwriters of their option to purchase up to an
additional 1,200,000 shares of common stock. Net proceeds to the
Company were approximately $21.3 million, after underwriting
discounts, commissions and estimated offering expenses.
Sienna announced on Feb. 8, 2019, top-line
results from three pivotal clinical trials for the reduction of
light-pigmented hair and from the third and final pivotal clinical
trial in acne with SNA-001, a topical, ready-to-use suspension of
silver particles to be used as a pre-treatment in conjunction with
the most common commercial lasers already utilized in aesthetic
clinics and laser centers today. The data showed SNA-001
successfully removed light hair when used with an 810 nm Diode
laser and met the primary endpoint of non-inferiority in hair
reduction (-17.5% with SNA-001+Laser compared to -1.1% with
vehicle+Laser following six treatment sessions). In additional
analyses, SNA-001 was statistically superior compared to
vehicle+Laser, demonstrating up to a 32% reduction of light hair
from baseline. SNA-001 was also evaluated in conjunction with a
1064 Nd:YAG and 755 nm Alexandrite laser for the reduction of light
hair, showing a significant reduction from baseline and providing a
potential path to regulatory clearance. These results, however,
were less differentiated from the vehicle+Laser group compared to
the 810 nm Diode laser study results. The third and final pivotal
trial of SNA-001 in acne demonstrated SNA-001 was non-inferior to
laser therapy. In all of these trials, SNA-001 was well tolerated,
with no unexpected, treatment-related adverse events observed.
These results provide a potential path to regulatory clearance in
light-pigmented hair removal and acne, and the Company is seeking a
strategic partner to maximize the value of SNA-001.
Sienna announced on Dec. 3, 2018, that the
Company’s tissue-targeted Tropomyosin receptor kinase A (TrkA)
inhibitor, SNA-120 (0.05%), demonstrated in a Phase 2b clinical
trial statistically significant improvement compared to vehicle on
important pre-specified endpoints of psoriasis disease severity,
including the Investigator’s Global Assessment (IGA) 2-grade
composite, comprising a 2-grade improvement from baseline and clear
(0) or almost clear (1) skin, which has been the Phase 3 primary
endpoint for recent topical psoriasis drugs approved by the U.S.
Food and Drug Administration (FDA). Specifically, 29% of patients
achieved success on the IGA 2-grade composite, compared to 13% of
subjects treated with vehicle. Additionally, 27% of subjects
experienced a 75% reduction from baseline in their Psoriasis Area
and Severity Index score (PASI 75), compared to 13% of subjects
treated with vehicle. Subjects also experienced an approximately
60% reduction from baseline in the associated pruritus (itch),
although the pruritus result did not reach statistical significance
compared to vehicle. SNA-120 has been administered to more than 500
subjects for up to 12 weeks and has been well tolerated across all
trials, with minimal to no demonstrated systemic bioavailability.
Following an End-of-Phase 2 (EOP2) meeting with the FDA scheduled
for April 2019, Sienna intends to initiate two Phase 3 pivotal
clinical trials for a psoriasis indication, subject to securing
sufficient capital to complete both trials, in the second half of
2019.
Sienna announced on Dec. 3 and Aug. 27, 2018,
results from exploratory Phase 1/2 studies in atopic dermatitis and
psoriasis, respectively, with SNA-125, the Company’s dual Janus
kinase 3 (JAK3)/TrkA inhibitor. In these studies, SNA-125 was well
tolerated and showed no safety signals. Additionally, histological
and biomarker analyses showed a modest drug effect in both atopic
dermatitis and psoriasis, despite using a prototype gel formulation
and treating a limited area for a short duration. Sienna intends to
initiate a Phase 2 study with a more optimal cream formulation of
SNA-125 first in atopic dermatitis, subject to securing sufficient
capital to complete the trial.
Selected Financial Results
Total operating expenses for the three months
ended Dec. 31, 2018, were approximately $19.8 million, which
includes research and development (R&D) expenses totaling
approximately $10.8 million and general and administrative
(G&A) expenses totaling approximately $9.0 million. Total
operating expenses for the three months ended Dec. 31, 2017, were
approximately $14.0 million, which included R&D expenses
totaling approximately $9.5 million and G&A expenses totaling
approximately $4.5 million. The year-over-year increase in R&D
expenses was due primarily to increased development costs related
to SNA-120 and SNA-125, partially offset by a reduction in costs
related to the pivotal trials for SNA-001. The year-over-year
increase in G&A expenses was due primarily to a $4.9 million
non-cash increase in expense related to the fair value of the
contingent consideration liability associated with the Company’s
acquisition of Creabilis plc in December 2016, partially offset by
a reduction in legal fees.
Total operating expenses for the twelve months
ended Dec. 31, 2018, were approximately $76.5 million, which
includes R&D expenses totaling approximately $51.6 million and
G&A expenses totaling approximately $24.9 million. Total
operating expenses for the twelve months ended Dec. 31, 2017, were
approximately $48.6 million, which included R&D expenses
totaling approximately $30.5 million and G&A expenses totaling
approximately $18.1 million. The year-over-year increase in R&D
expenses was due primarily to increased development costs related
to the clinical trials for SNA-120 and for SNA-125, increased
manufacturing costs to support the clinical trials for SNA-120 and
SNA-125 and increased costs related to early stage research
activities, offset by a reduction in costs related to the pivotal
trials for SNA-001. The year-over-year increase in G&A expenses
was due primarily to an increase in personnel costs, an increase in
expenses related to marketing research and a $3.3 million non-cash
increase in expense related to the fair value of the contingent
consideration liability associated with the Company’s acquisition
of Creabilis plc in December 2016.
Cash burn during the three months ended Dec. 31,
2018, was approximately $15.6 million. Cash burn during the twelve
months ended Dec. 31, 2018, was approximately $61.7 million.
Sienna’s cash and cash equivalents as of Dec. 31, 2018, totaled
approximately $48.5 million, which does not include the $21.3
million in net proceeds from the Company’s February 2019 follow-on
public offering.
About Sienna Biopharmaceuticals
Sienna Biopharmaceuticals, Inc. is a
clinical-stage biopharmaceutical company focused on bringing
unconventional scientific innovations to patients whose lives
remain burdened by their disease. We draw upon our deep knowledge
and experience in drug development across multiple therapeutic
areas as we build a unique, diversified, multi-asset portfolio of
therapies in immunology and inflammation that target select
pathways in specific tissues, with our initial focus on one of the
most important ‘immune’ tissues, the skin. We are leading the way
with our novel proprietary technology platform, applying a
scientific design process to create potent targeted
pharmacologically active molecules that are directed toward a
specific target tissue and a select disease pathway, and with
minimal to no systemic exposure. At Sienna, we are going where it
still matters for patients.
For more information, visit the Company’s
website at www.SiennaBio.com.
Forward-Looking Statements
This press release contains forward-looking
statements, including but not limited to statements by Sienna’s
Chief Executive Officer and other statements regarding Sienna’s
expectations for: SNA-120, including timing of its EOP2 meeting
with the FDA as well as timing to begin two Phase 3 pivotal
clinical trials; SNA-125, including its potential to treat other
inflammatory disorders of the skin, the gastrointestinal tract, the
eye and the lung and Sienna’s ability to fund any further clinical
trials of SNA-125; and SNA-001, including the potential for
regulatory clearance of SNA-001 and Sienna’s expectations related
to partnering SNA-001. Such forward-looking statements involve
substantial risks and uncertainties that could cause Sienna’s
clinical development programs, future results, performance or
achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in
the pharmaceutical drug and medical device development processes,
including regulatory approval processes, the timing of regulatory
filings, the challenges associated with manufacturing
pharmaceutical drug and medical device products, Sienna’s ability
to raise sufficient capital to fund its development programs, and
other matters that could affect the sufficiency of existing cash to
fund operations and the availability or commercial potential of
Sienna’s drug candidates. Sienna undertakes no obligation to update
or revise any forward-looking statements. For a further description
of the risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as
well as risks relating to the business of Sienna in general, see
Sienna’s most recent Annual Report on Form 10-K and any subsequent
current and periodic reports filed with the Securities and Exchange
Commission.
|
Sienna Biopharmaceuticals, Inc. |
Consolidated Statements of
Operations |
(in thousands, except per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedDecember
31, |
|
|
Twelve Months EndedDecember
31, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
10,774 |
|
|
$ |
9,465 |
|
|
$ |
51,592 |
|
|
$ |
30,484 |
|
|
General
and administrative |
|
|
8,995 |
|
|
|
4,525 |
|
|
|
24,906 |
|
|
|
18,087 |
|
|
Total operating
expenses |
|
|
19,769 |
|
|
|
13,990 |
|
|
|
76,498 |
|
|
|
48,571 |
|
|
Loss from
operations |
|
|
(19,769 |
) |
|
|
(13,990 |
) |
|
|
(76,498 |
) |
|
|
(48,571 |
) |
|
Other
income (expense), net |
|
|
434 |
|
|
|
2,722 |
|
|
|
3,027 |
|
|
|
(2,264 |
) |
|
Net loss before
taxes |
|
|
(19,335 |
) |
|
|
(11,268 |
) |
|
|
(73,471 |
) |
|
|
(50,835 |
) |
|
Income tax benefit |
|
|
— |
|
|
|
78 |
|
|
|
— |
|
|
|
290 |
|
|
Net loss |
|
$ |
(19,335 |
) |
|
$ |
(11,190 |
) |
|
$ |
(73,471 |
) |
|
$ |
(50,545 |
) |
|
Per share
information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss,
basic and diluted1 |
|
$ |
(0.93 |
) |
|
$ |
(0.56 |
) |
|
$ |
(3.59 |
) |
|
$ |
(5.19 |
) |
|
Basic and diluted
weighted average shares outstanding2 |
|
|
20,805 |
|
|
|
20,128 |
|
|
|
20,450 |
|
|
|
9,735 |
|
|
____________________
1 Diluted net loss per share is the same as
basic net loss per share, as the effects of potentially dilutive
securities are antidilutive during periods of net loss.2 As of Dec.
31, 2018, there were 21,177,123 shares of common stock
outstanding.
|
Sienna Biopharmaceuticals,
Inc. |
Selected Consolidated Balance Sheet
Data |
(in
thousands)(unaudited) |
|
|
December 31, 2018 |
|
|
December 31, 2017 |
|
Cash and cash
equivalents |
|
$ |
48,526 |
|
|
$ |
74,467 |
|
Working capital |
|
|
26,063 |
|
|
|
69,105 |
|
Total current
assets |
|
|
50,412 |
|
|
|
77,346 |
|
Total assets |
|
|
107,306 |
|
|
|
136,847 |
|
Total current
liabilities |
|
|
24,349 |
|
|
|
8,241 |
|
Long-term debt,
net |
|
|
30,125 |
|
|
|
— |
|
Accumulated
deficit |
|
|
159,368 |
|
|
|
85,897 |
|
Total stockholders’
equity |
|
|
26,581 |
|
|
|
91,199 |
|
|
|
|
|
|
|
|
|
|
Contact:
InvestorsSean
Andrewssandrews@siennabio.com818-629-2244
MediaCaroline Van
Hovecvanhove@siennabio.com818-575-6250
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