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): September 29, 2015

 

 

RXi PHARMACEUTICALS CORPORATION

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-54910   45-3215903

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(I.R.S. Employer

Identification Number)

257 Simarano Drive, Suite 101

Marlborough, Massachusetts 01752

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (508) 767-3861

 

 

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:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

Item 7.01 Regulation FD Disclosure.

On September 29, 2015, representatives of RXi Pharmaceuticals Corporation participated in the 15th Annual Biotech in Europe Forum for Global Partnering and Investment Conference in Switzerland. Copies of the presentations to be used during the conference are attached hereto as Exhibits 99.1 and 99.2 and are incorporated herein by reference.

The information under this Item 7.01 and in Exhibits 99.1 and 99.2 hereto is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information under this Item 7.01 and Exhibits 99.1 and 99.2 hereto shall not be deemed incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, unless otherwise expressly indicated in such registration statement or other document.

 

Item 9.01 Financial Statements and Exhibits.

 

  (d) Exhibits.

 

Exhibit
No.

   

Description

99.1    Conference Presentation, dated September 29, 2015
99.2    Panel Presentation, dated September 29, 2015

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.

 

    RXi PHARMACEUTICALS CORPORATION
Date: September 29, 2015     By:  

/s/ Geert Cauwenbergh

      Geert Cauwenbergh, Dr. Med. Sc.
      President, Chief Executive Officer and acting Chief Financial Officer

EXHIBIT INDEX

 

Exhibit
No.

   

Description

99.1    Conference Presentation, dated September 29, 2015
99.2    Panel Presentation, dated September 29, 2015


RXi Pharmaceuticals
NASDAQ: RXII
15th Annual Biotech in Europe Forum for
Global Partnering and Investment Conference
September 29, 2015
RXi Pharmaceuticals
NASDAQ: RXII
15th Annual Biotech in Europe Forum for
Global Partnering and Investment Conference
September 29, 2015
®
Exhibit 99.1

2
Property of RXi Pharmaceuticals
Forward Looking Statements
Forward Looking Statements
This presentation contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Words such as “believes,”
“anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests” and
similar expressions are intended to identify forward-looking statements. These
statements are based on RXi Pharmaceuticals Corporation’s (the “Company”) current
beliefs and expectations. Such statements include, but are not limited to, statements
about the future development of the Company’s products (including timing of clinical
trials and related matters associated therewith), the expected timing of certain
developmental milestones, the reporting of unblinded data, potential partnership
opportunities, the Company’s competition and market opportunity and pro forma
estimates. The inclusion of forward-looking statements should not be regarded as a
representation by the Company that any of its plans will be achieved.  Actual results
may differ from those set forth in this presentation due to risks and uncertainties in the
Company’s business, including those identified under “Risk Factors” in the Company’s
most recently filed Quarterly Report on Form 10-Q and in other filings the Company
periodically makes with the U.S. Securities and Exchange Commission.  The
Company does not undertake to update any of these forward-looking statements to
reflect a change in its views or events or circumstances that occur after the date of this
presentation.

3
Property of RXi Pharmaceuticals
Corporate Highlights
Corporate Highlights
Leader in development of advanced RNAi-based therapeutics
Novel,
self-delivering
RNAi
(sd-rxRNA
®
)
platform
provides
improved
cellular
uptake,
safety, potency and selectivity over classic siRNA
Developing innovative therapeutics in dermatology and
ophthalmology
Discovery and clinical development programs based on proprietary RNAi technology
and immunotherapy agents
RXI-109:
sd-rxRNA
®
compound initially being developed to reduce or inhibit scar
formation in the skin and retina
Samcyprone
™
: immunomodulator initially being developed for the treatment of
alopecia areata, warts, and cutaneous metastases of melanoma
Numerous clinical and business development opportunities
Extensive patent portfolio covering sd-rxRNA platform and additional compounds
Discovery and clinical pipeline with substantial market potential

4
Property of RXi Pharmaceuticals
Leader in the Development of Advanced
RNAi-based Therapeutics
Leader in the Development of Advanced
RNAi-based Therapeutics
The sd-rxRNA Platform
The sd-rxRNA Advantage
‘Self-delivering’ therapeutic compounds with
drug-like
properties
Single compound incorporates
activity and delivery
Structural diversity = novel intellectual property
Robust uptake & silencing in multiple preclinical models
Combines many positives of RNAi & antisense, while
avoiding many negatives
Provides for broad pipeline of RNAi drugs for unmet
medical needs
sd-rxRNA

5
Property of RXi Pharmaceuticals
Dermatology Franchise
Dermatology Franchise
Clinical
Multiple Development Opportunities
Program
Discovery
Preclinical
RXI-109
(Hypertrophic Scars &
Keloids)
Samcyprone™
(Alopecia Areata, Warts,
Cutaneous Metastases
Melanoma)
Anti-Collagenase
(Aging, Chronic wounds)
Anti-Tyrosinase
(Melasma, PIH, Lentigines)
Phase 1
Phase 2
Phase 3

6
Property of RXi Pharmaceuticals
Dermal Scarring: RXI-109
Unmet Medical Need with Large Market Potential
Dermal Scarring: RXI-109
Unmet Medical Need with Large Market Potential
Targeting Connective Tissue Growth Factor (CTGF)
Unmet need with limited competition for truly effective therapies
Trials initiated with RXi’s first clinical candidate: RXI-109
RXI-109 is an sd-rxRNA compound developed to reduce dermal and
retinal scarring
Large market in scar prevention/revision
Approximately 45M surgical procedures per year in the United States*
Depending on price point, annual market potential between $1-3B
Dermatology Franchise
*US
anti-scarring
market
–
The
Nemetz
Group
–
December
2009

7
Property of RXi Pharmaceuticals
RXI-109 Dermal Clinical Program
RXI-109 Dermal Clinical Program
Dermatology Franchise
Phase
1
RXI-109-1201 -
Single dose
Complete –
n=15
RXI-109-1202 -
Multi-dose
Complete –
n=15
Phase 2a
RXI-109-1301
-
Hypertrophic scars
Enrollment
and
treatment
complete.
Three
doses
over
a 2-week period. Data collection ongoing.  n=22
RXI-109-1401 -
Keloids
Enrollment
and
treatment
complete.
Four
doses
over
a 1-month period. Data collection ongoing.  n=16
RXI-109-1402 -
Hypertrophic
scars
Extended dosing based on previous clinical results.
Six
doses
over a 3-month
period.  n=20
Phase 2b
Projected
initiation 2016
Phase 3
Projected initiation 2018

8
Property of RXi Pharmaceuticals
Phase 2a: Scar Comparison at 3 Months
Treatment with RXI-109 Initiated Two Weeks Post
Scar Revision Surgery
Phase 2a: Scar Comparison at 3 Months
Treatment with RXI-109 Initiated Two Weeks Post
Scar Revision Surgery
Phase 2a: RXI-109-1301
Pre-scar
revision
surgery
3 months
post-scar
revision
surgery
PLACEBO
RXI-109
*White dots are markers used in clinical photography.

9
Property of RXi Pharmaceuticals
Topical
Immunotherapy:
Samcyprone
™
Topical
Immunotherapy:
Samcyprone
™
Samcyprone
™
-
RXi’s second clinical candidate
A proprietary topical formulation of diphenylcyclopropenone (DPCP)
DPCP is a topical immunomodulator that works by eliciting a T-cell response
Efficacy in the three target indications, alopecia areata, warts, and
cutaneous metastasis of melanoma, reported in peer-reviewed journals
with DPCP
Orphan-drug designation of Samcyprone
™
for malignant melanoma stage IIb
to IV
Combined market for three indications estimated >$1B
Major competitors for treatment of warts: Aldara
™
(Imiquimod) and Picato
®
(Ingenol mebutate)
Dermatology Franchise

10
Property of RXi Pharmaceuticals
Treatment with Diphencyprone (DPCP)
DPCP
is
the
Active
Ingredient
in
Samcyprone
™
Treatment with Diphencyprone (DPCP)
DPCP
is
the
Active
Ingredient
in
Samcyprone
™
Alopecia Areata
Cotellessa, C et al. JAAD 2001;44:73-6
•
>200 patients treated for several months
•
Response rates of 67-78%
Warts
(refractory plantar & periungual)
Choi, Y et al.  Ann Dermatol. 2013, 25
4:434-439
•
>350
patients
treated
for
12
–
24
weeks
•
Response
rates
of
80
-
85%
Cutaneous
Metastases
of Melanoma (refractory)
Damian, DL et al. J Surg Oncol 2014,
109:308-313
•
50 patients with mean of 15 months
treatment
•
46% complete clearance and 38% partial
clearance
Dermatology Franchise

11
Property of RXi Pharmaceuticals
Ophthalmology Franchise
Ophthalmology Franchise
Program
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
Clinical
Multiple Development Opportunities
Retinal scarring
(Macular Degeneration)
Corneal scarring
(Topical)
“Self-Delivering” (“sd”)
Adaptation to acquired
OPKO estate
New targets

Property of RXi Pharmaceuticals
sd-rxRNA         
Stabilized 
Placebo
siRNA
Mouse
immediately
post-dose
Mouse at
24 hours
post-dose
Mouse at
24 hours
post-dose
Rabbit at
24 hours
post-dose
•
Dosing by intravitreal injection to mouse or
rabbit eye
•
Dy547-labeled sd-rxRNA, stabilized siRNA
or placebo
sd-rxRNA: In Ophthalmology
Improved Delivery vs. Stabilized RNAi
sd-rxRNA chemistry is
required for robust uptake
to the cells of the eye
No overt toxicity observed
after sd-rxRNA treatment
to the eye
Byrne et al., JOPT.
December 2013, 29(10): 855-864.
Ophthalmology Franchise
12

13
Property of RXi Pharmaceuticals
CTGF Protein Levels in the NHP Retina and Cornea
Decrease Following Treatment with RXI-109
Retina
Cornea
CTGF protein levels
are reduced in a dose
dependent manner
7-days following single
intravitreal injection
of RXI-109
Treatment Dose
Treatment Dose
PBS
0.1 mg
0.33 mg
1 mg
*
**
*
*  p < 0.05, ** p < 0.01
Ophthalmology Franchise
0
5
10
15
20
25
30
35
40
45
PBS
0.1 mg
0.33 mg
1 mg
0
5
10
15
20
25
30
35
40
45
PBS
0.1 mg
0.33 mg
1 mg

14
Property of RXi Pharmaceuticals
Research and Development Programs
New Targets for Potential Preclinical Development
MMP1 enzyme involved in breakdown of extracellular matrix
Collagenase (MMP1)
•
Potent MMP1 sd-rxRNAs identified for potential for preclinical development such as skin
aging disorders including photo aging
TYR key enzyme in synthesis of melanin
Tyrosinase (TYR) 
•
Potent TYR sd-rxRNAs identified for potential discovery and preclinical development.
Potential indications include cutaneous hyperpigmentation disorders, lentigines (age spots,
liver spots, freckles)
Acquired estate provides multiple development opportunities
OPKO RNAi Assets
•
Novel potent sd-rxRNA compounds targeting VEGF for potential intra-ocular therapy for
age-related macular degeneration
•
Other targets -
discovery stage efforts ongoing
Combined
multi-billion
dollar
global
market
potential
Market Potential
Multiple Development Opportunities

15
Property of RXi Pharmaceuticals
Research and Development Programs
New Targets for Potential Preclinical Development
Research and Development Programs
New Targets for Potential Preclinical Development
MMP1
TYR
VEGF
DISCOVERY
Target
Selection
In Progress
Bioinformatics
Pending
Compound Synthesis
Pending
In vitro Screening
Pending
File IP
Pending
Chemical Optimization
Pending
Pending
Test in Relevant Models
(in vitro and in vivo)
In Progress
In Progress
Pending
Pending
Lead
Candidate
Identification
In Progress
Q4 2015
In Progress
Q4 2015
Pending
Pending
Multiple Development Opportunities

16
Property of RXi Pharmaceuticals
NTC
UTC
MMP-26038
0 h
24 h
48 h
72 h
MMP1 –
Targeting sd-rxRNA Compounds
Reduced
Migration
Rate
of
A549
Lung
Carcinoma
Cells
in
vitro
0
100
200
300
400
500
600
700
800
900
1000
Comparison of A549 Cell Migration after
Treatment with MMP1 Targeting sd-rxRNA
48 h
24 h
72 h
48 h
24 h
72 h
•
Scratch migration assay -
A549 non-small cell lung carcinoma cell line
•
Cells in culture treated with MMP1 –
targeting sd-rxRNA, non-targeting control (NTC), or
untreated control (UTC)
•
Reduced migration in the scratch assay may indicate a reduction in the invasive nature of the
cancer cell due to MMP1 reduction as a result of sd-rxRNA treatment

17
Property of RXi Pharmaceuticals
TYR –
Targeting sd-rxRNA Compounds
Lead to a Visible Reduction of Pigmentation in vitro
TYR –
Targeting sd-rxRNA Compounds
Lead to a Visible Reduction of Pigmentation in vitro
NTC
TYR -
21698
TYR -
26231
•
MelanoDerm™ 3-dimensional epidermal culture model containing melanocytes
•
Fourteen day culture with TYR-targeting sd-rxRNA added to culture media
Light
microscopy
Multiple Development Opportunities
Histological
cross section
with staining
for melanin

18
Property of RXi Pharmaceuticals
RXII:  Driving Growth and Innovation
RXII:  Driving Growth and Innovation
Research & Development
Communicate preliminary read-outs for RXI-109-1402
Phase 2a for Hypertrophic Scars
Q4 2015
Initiate Phase 1/2
trial in ophthalmology with RXI-109
Q4 2015
Initiate
Phase 2 trial for cutaneous warts with Samcyrone
™
Q4 2015
Identify
lead
sd-rxRNA
candidates
targeting
Collagenase
(MMP1)
and Tyrosinase
Q4 2015
7 Initiatives for Value Creation –
Next 12 Months
Business Development
Partner/Collaborate with other companies
create proprietary sd-rxRNA compounds against targets of their choice
Out-license/Create spin-out
outside of RXi’s core strategic areas
Maximize
potential of sd-rxRNA platform
in exchange for equity in the receiving
company
(e.g. MirImmune license)
Generate
larger deals with equity investment by strategic regional partners


RXi Pharmaceuticals
NASDAQ: RXII
Panel: Platform Technologies and
Novel Therapeutics
15th Annual Biotech in Europe Forum for Global
Partnering and Investment Conference
September 29, 2015
RXi Pharmaceuticals
NASDAQ: RXII
Panel: Platform Technologies and
Novel Therapeutics
15th Annual Biotech in Europe Forum for Global
Partnering and Investment Conference
September 29, 2015
®
Exhibit 99.2

2
Property of RXi Pharmaceuticals
Forward Looking Statements
This
presentation
contains
forward-looking
statements
within
the
meaning
of
the
Private
Securities
Litigation
Reform
Act
of
1995.
Words
such
as
“believes,”
“anticipates,”
“plans,”
“expects,”
“indicates,”
“will,”
“intends,”
“potential,”
“suggests”
and
similar
expressions
are
intended
to
identify
forward-looking
statements.
These
statements
are
based
on
RXi
Pharmaceuticals
Corporation’s
(the
“Company”)
current
beliefs
and
expectations.
Such
statements
include,
but
are
not
limited
to,
statements
about
the
future
development
of
the
Company’s
products
(including
timing
of
clinical
trials
and
related
matters
associated
therewith),
the
expected
timing
of
certain
developmental
milestones,
the
reporting
of
unblinded
data,
potential
partnership
opportunities,
the
Company’s
competition
and
market
opportunity
and
pro
forma
estimates.
The
inclusion
of
forward-looking
statements
should
not
be
regarded
as
a
representation
by
the
Company
that
any
of
its
plans
will
be
achieved.
Actual
results
may
differ
from
those
set
forth
in
this
presentation
due
to
risks
and
uncertainties
in
the
Company’s
business,
including
those
identified
under
“Risk
Factors”
in
the
Company’s
most
recently
filed
Quarterly
Report
on
Form
10-Q
and
in
other
filings
the
Company
periodically
makes
with
the
U.S
Securities
and
Exchange
Commission.
The
Company
does
not
undertake
to
update
any
of
these
forward-looking
statements
to
reflect
a
change
in
its
views
or
events
or
circumstances
that
occur
after
the
date
of
this
presentation.

3
Property of RXi Pharmaceuticals
From Platform to Product Company
Platforms build on creative new ideas that can be broadly
applied in drug development
Platform companies struggle because their value is determined
by ultimate product success
Result:
Companies disappear or the value of their platform is
not maximized (few disease areas only)
Result:
Fewer patients get the benefit from use of the innovation
Result: Reduced shareholder value due to under-utilized
platform
How Patients have Suffered in the Transition

4
Property of RXi Pharmaceuticals
Platform Technologies & Novel Therapeutics
Challenge:
Evolve from a Platform-based Company into a Product-
based Company while preserving the total value and
potential of the Company.
Solution:
Identify innovative ways to capitalize on portions of the
platform outside the Company’s strategic core focus in
order to broaden the development of and access to novel
therapeutics for patients and physicians, while building
shareholder value.

5
Property of RXi Pharmaceuticals
Transition
Platform to Product Company
Maintain Optimum Use of Innovation
Identify
Strategic identification of the disease areas in which your
company wants to compete and which allow for demonstration
of proof of concept of the platform in the near term
Select
1–3 product candidates from your platform for internal
development in the selected disease areas
Collaborate
Form research partnerships where relevant for optimum
delivery of the selected development candidates
Maximize IP
Create immediate shareholder value by maximizing platform IP
as a venture investment tool in start-up biotech firms, similar to
venture capital funds
Partner
Conventional business development effort with large
companies; including R&D contracts or through conventional
out-licensing efforts

6
Property of RXi Pharmaceuticals
Example: RXi Pharmaceuticals
Started as platform RNAi company
Transformational self-delivering RNAi (sd-rxRNA
®
) platform
Multiple potential disease area targets
Core Focus: Dermatology & Ophthalmology selected for product
development
Collaborations ongoing with 3 formulation companies
Invested in an oncology cell therapy company through IP license
to RXi’s self-delivering platform
Negotiating a similar approach in another therapeutic area
Negotiating conventional business development arrangements with
larger regional/global firms
Transition from Platform to Product Company

7
Property of RXi Pharmaceuticals
sd-rxRNA
®
: RXi’s Proprietary Platform
RXi’s unique sd-rxRNA platform allows for rapid identification of lead compounds
for multiple targets in different therapeutic areas
RXi’s Strategic Core Focus
Open for Partnering/Licensing
sd-rxRNA Platform
Dermatology
Scarring (fibrosis)
Hyperpigmentation disorders
Photo aging
Ophthalmology
Retinal scarring
AMD, PVR
Corneal scarring
Local Delivery
Arthritis
Endometriosis
Lung Fibrosis
Chronic
wounds
Systemic & Cancer
Liver fibrosis
Kidney fibrosis
Cancer
Cell Therapy
Exclusive license to
platform for cell-based
immunotherapies in cancer
Other therapeutic areas for
cell therapy still available
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