Full Press Release Details
Pharmaceuticals Reports Second Quarter 2018 Financial Results and Recent Corporate Highlights
August 14, 2018 /PRNewswire/ RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation
of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA ) therapeutic platform today reported
its financial results for the second quarter ended June 30, 2018 and provided a business update.
report provides good insights into the progress of the transition announced in January 2018, when RXi management informed its shareholders
of the corporate focus on immuno-oncology and adoptive cell transfer therapy," said Dr. Geert Cauwenbergh, President &
CEO of RXi Pharmaceuticals. He added that, "For the first 6 months of 2018, spending has been reduced by 26% as compared to
the first half of 2017, with about half the reduction from one-time charges relating to the acquisition of MirImmune in Q1 of 2017,
and the remainder resulting from a reduction in general and administrative expenses as compared to the same period last year."
He indicated that: "The successful completion of our clinical studies in dermatology and ophthalmology have added significant
human clinical data on efficacy and safety of the sd-rxRNA platform to our data packages, that should be valuable for companies
that are considering a potential acquisition of those assets, including potential licenses to our self-delivering platform for
those therapeutic categories. We would expect the execution of such an agreement to provide us with non-dilutive cash that could
extend our financial runway significantly." He finally added that: "In comparison with our track record for deal-making
in dermatology and ophthalmology between 2012 and 2017, our partnering history of the past 9 months, including strong IO &
ACT partnerships with leading academic and industrial partners, indicates a much better visibility with stronger interest in our
sd-rxRNA approach than ever before. We aim to take advantage of this surge in partnering interest, to enhance the value of our
Company for our shareholders."
host a conference call today at 4:30 p.m. EDT to discuss financial results and provide an update on the Company. The
webcast link will be available under the "Investors - Event Calendar" section of the Company's website, www.rxipharma.com.
The event may also be accessed by dialing toll-free in the United States and Canada: +1 844-376-4678. International
participants may access the event by dialing: +1 209-905-5958. An archive of the webcast will be available on the Company's website
approximately two hours after the presentation.
Select Second Quarter 2018 Financial
At June 30, 2018, the Company had cash
and cash equivalents of $5.3 million as compared with $3.6 million at December 31, 2017.
On April 11, 2018, the Company closed
on a registered direct offering of 1,510,604 shares of the Company's common stock at a purchase price of $3.15 per share.
Concurrently, the Company also commenced a private placement, whereby it issued and sold warrants exercisable for a total of 1,132,953
shares of common stock with a purchase price per share of $0.125 per underlying warrant share and with an exercise price of $3.15
per share. Assuming the warrants are not exercised, net proceeds to the Company were approximately $4.2 million after deducting
placement agent fees and estimated offering expenses.
Under the Company's purchase agreement
with Lincoln Park Capital Fund, LLC ("LPC"), the Company sold a total of 420,000 shares of common stock to LPC for
net proceeds of approximately $1.3 million during the six months ended June 30, 2018. There remains approximately $13 million available
under the purchase agreement with LPC, subject to certain limitations and conditions set forth therein.
Revenues for the three months ended June
30, 2018 were $58,000 and related to the work performed by the Company as a sub-awardee under the government grant awarded to our
collaborator BioAxone Biosciences, Inc. from the National Institute of Neurological Disorders and Stroke. The grant provides funding
for the development of a novel sd-rxRNA compound, BA-434, that targets PTEN for the treatment of spinal cord injury. The Company
had no revenues during the three months ended June 30, 2017.
Research and Development Expenses
Research and development expenses for the
quarter ended June 30, 2018 were $1.2 million, as compared with $1.3 million for the quarter ended June 30, 2017. The decrease
was primarily due to a decrease in clinical-trial related expenses as subject participation is now complete for all of the Company's
Acquired In-process Research and
The Company did not have acquired in-process
research and development expense for the three months ended June 30, 2018. During the three months ended June 30, 2017, the Company
recorded acquired in-process research and development expense related to the fair value of consideration given in the acquisition
General and Administrative Expenses
General and administrative expenses for
the quarter ended June 30, 2018 were $0.8 million, as compared with $1.1 million for the quarter ended June 30, 2017. The decrease
was primarily due to decreases in professional fees for legal-related services and payroll-related expenses as a result of a decrease
Net loss for the quarter ended June 30,
2018 was $1.9 million, compared with $2.5 million for the quarter ended June 30, 2017. The decrease was primarily due to a decrease
in operating expenses, as discussed above.
Select Second Quarter 2018 and Recent Corporate Highlights
Select Business and Corporate Highlights
its internal development programs, the Company has entered into several partnerships across the globe to expand its pipeline to
advance development of the next generation immunotherapies for the treatment of cancer.
In May 2018, RXi established a research collaboration with Iovance Biotherapeutics to
evaluate potential synergies between RXi's novel sd-rxRNA therapeutic compounds and Iovance's autologous cell therapy based on
tumor-infiltrating lymphocytes (TILs) for use in the treatment of cancer.
the journal Molecular Therapy published "Self-Delivering RNAi (sd-rxRNA ) Targeting PD-1 using Adoptive Cell Therapy Approach
for the Treatment of Malignant Melanoma". In this paper scientists demonstrate the potential of improving therapy with patient-derived
tumor infiltrating lymphocytes (TILs) by treatment with RXi's novel sd-rxRNA compound that specifically targets PD-1.
Clinical Trials - Dermatology and Opthalmology
positive news from both its Dermatology and Opthalmology Franchises, with each franchise comprising advanced clinical programs,
robust discovery assets and substantial Intellectual Property rights. The Company has an active process underway to monetize these
assets, which would support a return on investment for stockholders and accelerated growth in the immuno-oncology focus area.
Samcyprone for the Treatment
Samcyprone is a proprietary topical
formulation of the small molecule diphenylcyclopropenone (DPCP), a topical immunomodulator that works by initiating a T-cell response.
Completed Phase 2 trial RXI-SCP-1502, was a multi-center, multi-dose trial conducted in subjects with at least one cutaneous, plantar
or periungual wart present for at least four weeks. The study successfully met its primary effectiveness objectives and its secondary
safety and tolerability objectives. In addition to the key study objectives, a large amount of data was collected that can inform
the design of further pivotal studies in support of future marketing applications.
RXI-109 for the Reduction of Retinal
RXI-109 is a self-delivering therapeutic
RNAi compound that targets connective tissue growth factor (CTGF), a key regulator in fibrosis and scar formation. RXI-109-1501
was a multi-dose, dose escalation trial conducted in subjects with advanced neovascular or 'wet' age-related macular degeneration
and accompanying subretinal fibrosis. This study successfully met its primary objective by showing that RXI-109 is safe and well
tolerated in this dose escalation study. This was shown by the absence of dose-limiting and serious toxicities, and only mild to
moderate procedure-related adverse events. None of the adverse events were drug related. In addition, comprehensive ocular examinations
showed no indications of inflammation or any other tolerability issues related to the treatment. In addition, RXI-109 met its secondary
objectives, with improved or stable disease in the study eyes in several subjects.
Intellectual Property
The European Patent Office (EPO) and
Japan Patent Office (JPO) have granted patents for the Company's novel self-delivering RNAi (sd-rxRNA ) therapeutic platform.
The EPO Patent #: 2949752 B1 and JPO Patent #: 620309 cover composition of matter, specifically structural and chemical attributes
of sd-rxRNA. These patents will be set to expire in 2029.
About RXi Pharmaceuticals
RXi Pharmaceuticals Corporation (NASDAQ:
RXII) is a biotechnology company developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi
(sd-rxRNA ) therapeutic platform. The Company's discovery and research efforts are focused on developing sd-rxRNA therapeutic
compounds to be used with an Adoptive Cell Transfer (ACT) approach. This process uses immune cells, such as T-lymphocytes that
are isolated from the patient or retrieved from allogeneic immune cell banks, and then expanded and in some cases processed to
express tumor-binding receptors. Our approach introduces a new and important step in ex-vivo processing of
the immune cells where sd-rxRNA is used to eliminate the expression of immunosuppressive receptors or proteins from the therapeutic
immune cells, making them less sensitive to tumor resistance mechanisms and thus improving their ability to destroy the tumor cells.