On August 14, 2018 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 reported its financial results for the second quarter ended June 30, 2018 and provided a business update (Press release, RXi Pharmaceuticals, AUG 14, 2018, View Source [SID1234528883]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The Q2 financial 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."
The Company will host a conference call today at 4:30 p.m. ET 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 Highlights
Cash Position
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
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 clinical trials.
Acquired In-process Research and Development Expense
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 of MirImmune.
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 in headcount.
Net Loss
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
Immuno-oncology
In addition to 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.
On April 16, 2018, 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
The Company issued 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 of Cutaneous Warts
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 Scarring
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.