MALVERN, Pa., Aug. 14,
2018 /PRNewswire/ -- Realm Therapeutics plc (NASDAQ:RLM /
AIM:RLM), a clinical stage biopharmaceutical company focused on
developing novel therapeutics in immune-mediated diseases, today
reports preliminary top-line data from its Phase 2 trial of PR022
in Atopic Dermatitis, as well as financial results for the six
months ended June 30, 2018.
In a randomized, double-blind, vehicle controlled, Phase 2
clinical trial of 122 patients, PR022 showed no difference from
vehicle in the primary endpoint of percent change in Eczema Area
Severity Index (EASI) versus baseline.
"PR022 did not show the desired effect in this trial," said
Alex Martin, CEO of Realm
Therapeutics. "Having just received the data, we are working to
better understand this outcome and to analyze all of the data
collected in the study. We are conducting a full review to
determine whether there is a path forward for our proprietary
technology in Atopic Dermatitis, and to evaluate the implications
for our Acne and Psoriasis programs. We will provide an update on
our plans in September. I would like to thank the patients and
investigators who participated in this trial."
CORPORATE AND FINANCIAL HIGHLIGHTS
- Cash, cash equivalents and short-term investments were
$23.7 million at June 30, 2018 (at December
31, 2017: $33.9m).
- Investments in Research & Development increased to
$7.4 million (H1 2017: $3.0m) driven by increased investment in clinical
development activities.
- General and Administrative expenses increased to $3.5 million (H1 2017: $1.6m) primarily due to Nasdaq listing
costs.
- In July 2018, Realm listed
American Depositary Shares (ADSs) representing the Company's
ordinary shares on the Nasdaq Capital Market to facilitate the
creation of a trading market in the US for the Company's securities
and in satisfaction of obligations under a registration rights
agreement entered into with investors who participated in the
Company's October 2017 private
placement.
- The US Patent and Trademark Office issued two new patents to
Realm that expand the intellectual property portfolio around the
Company's proprietary immunomodulatory technology in the treatment
of inflammatory and autoimmune disorders.
Conference Call
The Company will host a conference call and audio webcast today
at 9:00 a.m. ET / 2:00 p.m. BST to discuss the Atopic Dermatitis
Phase 2 trial results and the financial results. To access the
conference call, please use the dial in details below:
US Toll-Free: +1
855-857-0686
US Toll: +1 631-913-1422
UK Toll-Free: 08003589473
UK Toll: +44 3333000804
Conference call pin code: 51680194#
Please dial in at least 10 minutes prior to the start
time. A live and archived audio webcast of the call will be
available on the Events and Presentations page of the Company's
website, www.realmtx.com.
Availability of Other Information
The Company has submitted a Form 6-K to the Securities and
Exchange Commission (SEC) which includes as exhibits: Unaudited
Financial Statements and Notes prepared on a US GAAP basis,
Management's Discussion & Analysis, Risk Factors related to the
business and a copy of this press release. These documents
can be accessed from the Investor section of the Company's website
at www.realmtx.com.
About Realm Therapeutics
Realm Therapeutics is a clinical-stage biopharmaceutical company
developing novel therapeutics that target the interplay between
innate and adaptive immunity. The Company's programs seek to
influence immune signalling and change the course of
immune-mediated diseases in adults and children. Realm's lead drug
development program utilizes the Company's proprietary
immunomodulatory technology for the treatment of Atopic Dermatitis,
and the Company is exploring its efficacy in other dermatology
indications which include Acne Vulgaris and Psoriasis, as well as
other therapeutic areas. For more information on Realm Therapeutics
please visit www.realmtx.com.
Pipeline
PR022 is a proprietary, non-alcohol based, topical gel
formulation of high concentration hypochlorous acid (HOCl).
Realm is evaluating PR022 for potential application in Atopic
Dermatitis and Psoriasis. RLM023 is a topical formulation of
HOCl that is being optimized and evaluated for Acne Vulgaris.
Forward Looking Statements
Certain statements made in this announcement are
forward-looking statements, including with respect to the Company's
clinical trials, results of clinical trials, pipeline of candidates
and product candidate development plans including trial results,
next steps in clinical development, regulatory strategy, costs and
timelines. Words such as 'anticipates,' 'expects,' 'intends,'
'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions
are intended to identify forward-looking statements. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking
statements. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from our
expectations expressed or implied by the forward-looking
statements, including, but not limited to, the following: our
history of operating losses; the recently announced results of the
Phase 2 trial of PR022 in Atopic Dermatitis and the uncertainty
around future plans for PR022 or any other product candidates; the
impact of the PR022 Phase 2 results on our development plans for
other potential product candidates or indications; uncertainty
around our need for additional funding to advance development and
commercialization of any current or future product candidates,
which may not be available and which may force us to delay, reduce
or eliminate our development or commercialization efforts; the
reliance of our business on PR022 in Atopic Dermatitis;
economic, regulatory and other risks; the lengthy and expensive
process of drug development, which has an uncertain outcome;
undesirable or unacceptable side effects associated with any of our
pipeline candidate; the uncertainty of our ability to develop or
acquire products not based on our active pharmaceutical ingredient
(API) hypochlorous acid (HOCl) or outside of dermatology
leading to a high concentration of risk in limited areas; certain
risks associated with HOCl including its inherent instability and
the fact that there are other companies which make HOCl-based
products; the loss of any key personnel from our relatively small
team; potential material differences between our reported top-line
data and final data; our reliance on third parties, including
clinical research organizations, investigators, manufacturers and
other suppliers; and lawsuits related to patents covering HOCl,
PR022 and our pipeline candidates and the potential for our patents
to be found invalid or unenforceable. In addition, following
the listing of ADSs representing our ordinary shares on Nasdaq, the
Company is listed on two stock exchanges which results in higher
operating costs and varied regulatory obligations both of which are
impacted by the Company's status as a Foreign Private Issuer and
Emerging Growth Company which could change over time; and the
uncertainty with respect to an active market being established for
the ADSs. These risks and uncertainties and
other important factors are referred to in an exhibit to our Form
6-K filed with the Securities and Exchange
Commission (SEC) on August 14, 2018, and our other
reports filed with the SEC, could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management's estimates as of the date of this
press release. While we may elect to update such forward-looking
statements at some point in the future, we disclaim any obligation
to do so, even if subsequent events cause our views to change,
except as required by law or by any appropriate regulatory
authority. These forward-looking statements should not be relied
upon as representing our views as of any date subsequent to the
date of this press release.
G-RLM
Realm Therapeutics
plc
Consolidated
Balance Sheets
(in thousands
except share and per share data)
(unaudited)
|
|
|
|
|
|
June 30,
2018
|
|
December 31,
2017
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
16,236
|
|
$
9,508
|
Marketable
securities
|
7,433
|
|
24,345
|
Royalty
receivable
|
757
|
|
444
|
Prepaid expenses and
other assets
|
203
|
|
245
|
Total current
assets
|
24,629
|
|
34,542
|
Property and
equipment, net
|
252
|
|
246
|
Royalty receivable,
net of current portion
|
1,570
|
|
—
|
Other
assets
|
280
|
|
320
|
Total
assets
|
$
26,731
|
|
$
35,108
|
Liabilities and
Shareholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,233
|
|
$
1,009
|
Accrued
expenses
|
1,216
|
|
1,902
|
Total
liabilities
|
2,449
|
|
2,911
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
Ordinary shares, £0.10
nominal value: 154,897,265 ordinary shares authorized at
June 30, 2018: 116,561,917 ordinary shares were issued and
outstanding at
June 30, 2018 and December 31, 2017
|
24,259
|
|
24,259
|
Additional paid-in
capital
|
198,009
|
|
197,722
|
Accumulated other
comprehensive loss
|
(27)
|
|
(11)
|
Accumulated
deficit
|
(197,959)
|
|
(189,773)
|
Total shareholders'
equity
|
24,282
|
|
32,197
|
Total liabilities and
shareholders' equity
|
$
26,731
|
|
$
35,108
|
|
|
|
|
Realm Therapeutics
plc
Consolidated
Statements of Operations and Comprehensive Loss
(in thousands
except share and per share data)
(unaudited)
|
|
|
|
|
|
Six Months Ended
June 30,
|
|
2018
|
|
2017
|
Revenues
|
$
-
|
|
$
619
|
Operating
expenses:
|
|
|
|
Research and
development
|
7,376
|
|
2,968
|
General and
administrative
|
3,518
|
|
1,602
|
|
10,894
|
|
4,570
|
Loss from
operations
|
(10,894)
|
|
(3,951)
|
Interest
income
|
248
|
|
18
|
Net loss
|
(10,646)
|
|
(3,933)
|
Other comprehensive
loss:
|
|
|
|
Unrealized loss on
investments
|
(13)
|
|
-
|
Foreign exchange
translation adjustment
|
(3)
|
|
9
|
Total comprehensive
loss
|
$
(10,662)
|
|
$
(3,924)
|
|
|
|
|
Net loss per ordinary
share - basic and diluted
|
$
(0.09)
|
|
$
(0.08)
|
|
|
|
|
Weighted average
ordinary shares - basic and diluted
|
116,561,917
|
|
50,165,432
|
|
|
|
|
Realm Therapeutics
plc
Consolidated
Statement of Cash Flows
(in
thousands)
(unaudited)
|
|
|
|
Six Months Ended
June 30,
|
|
2018
|
|
2017
|
Cash flows from
operating activities:
|
|
|
|
Net loss
|
$
(10,646)
|
|
$
(3,933)
|
Adjustments to
reconcile net loss to net cash used in operating
activities
|
|
|
|
Loss on disposal of
property and equipment
|
-
|
|
3
|
Depreciation and
amortization
|
39
|
|
39
|
Noncash interest
income
|
(70)
|
|
-
|
Share-based
compensation
|
287
|
|
141
|
Changes in operating
assets and liabilities:
|
|
|
|
Royalty
receivable
|
647
|
|
(210)
|
Prepaid expenses and
other assets
|
81
|
|
3
|
Accounts payable and
accrued expenses
|
(462)
|
|
(718)
|
Net
cash used in operating activities
|
(10,124)
|
|
(4,675)
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
Purchase of marketable
securities
|
(10,932)
|
|
-
|
Proceeds from sale of
marketable securities
|
27,831
|
|
-
|
Purchases of property
and equipment
|
(45)
|
|
(108)
|
Net cash
provided by (used in) continuing investing activities
|
16,854
|
|
(108)
|
Net cash
used in discontinued investing activities
|
-
|
|
(1,093)
|
Net cash
provided by (used in) investing activities
|
16,854
|
|
(1,201)
|
Effect of exchange
rate changes on cash
|
(2)
|
|
9
|
|
|
|
|
Net increase
(decrease) in cash and cash equivalents
|
6,728
|
|
(5,867)
|
Cash and cash
equivalents, beginning of period
|
9,508
|
|
21,430
|
Cash and cash
equivalents, end of period
|
$
16,236
|
|
$
15,563
|
Supplemental cashflow
information:
|
|
|
|
Adjustment to royalty
receivables upon adoption of ASC 606
|
$
(2,460)
|
|
$
-
|
|
|
|
|
Contacts:
Realm Therapeutics plc
Alex Martin, Chief Executive
Officer
Marella Thorell, Chief Financial
Officer and Chief Operating Officer
Outside US: +44 (0) 20 3727 1000
US: +1 212 600 1902
Argot Partners
Laura Perry / Maghan Meyers
+1 212 600 1902
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SOURCE Realm Therapeutics