BUFFALO GROVE, Ill., April 23, 2015 (GLOBE NEWSWIRE) -- RestorGenex Corporation (OTCQB:RESX), a specialty biopharmaceutical company focused on developing products for oncology, ophthalmology and dermatology, is pleased to present its Annual Letter to Stockholders from CEO, Stephen M. Simes.
2014 was a defining year for RestorGenex. Following our acquisition of four corporate entities and the completion of a private placement financing that raised $35.6 million in gross proceeds, RestorGenex successfully established itself as a specialty biopharmaceutical company developing treatments for ophthalmology, oncology and dermatology. Conducting pre-clinical work for our two proprietary compounds in development, RES-529 and RES-440, has been and will continue to be the focus of our efforts throughout 2015. These pre-clinical activities will set the path for the robust clinical program we have planned for 2016, which includes the initiation of three Phase I/II clinical trials.
RestorGenex's lead compound, RES-529, is a first-in-class PI3k/AKT/mTOR pathway inhibitor. RES-529 has completed two Phase I trials for wet age-related macular degeneration (AMD) and a number of pre-clinical studies in the treatment of cancer including glioblastoma multiforme (an aggressive type of brain cancer), breast, prostate and lung. The PI3k/AKT/mTOR pathway is an important signaling pathway for many cellular functions, such as cell proliferation, angiogenesis and vascular permeability. Mutations within this pathway are associated with uncontrolled cell growth in many tumors, which is why we believe it will be efficacious in multiple cancer indications.
RES-529 is under development as a subconjunctival therapy for AMD, a degenerative disease of the eye, and the leading cause of vision loss in people over 50 years of age. In the United States, there are 11 million cases of wet AMD, a number that is expected to double by 2050 as the population ages. According to Defined Health, the worldwide wet AMD market is greater than $5 billion. In-vitro studies have shown that RES-529 successfully inhibits the PI3k/AKT/mTOR pathway via its effects on TORC1 and TORC2 and may be useful in treating the proliferative nature of the disease. We believe the longer-lasting half-life of RES-529 will enable less frequent dosing than the current standard of care. In addition, the alternate route of administration, subconjunctival versus intravitreal, will be an important therapeutic advantage. Thus far, two Phase I trials have been performed with RES-529, and we plan the next stage of development for wet AMD to include a Phase I/II clinical trial in 2016 to assess safety, tolerability and clinical efficacy and to identify the maximum tolerated dose of subconjunctival administration.
RES-529 also is under development as an oral formulation for glioblastoma multiforme (GBM), the most severe form of brain cancer and an orphan disease. GBM affects more than 24,000 people in the United States and even those under the current standard of care have median survival time of only 12 to 14 months. According to Defined Health, the GBM market is currently valued at $1 billion with analysts forecasting worldwide sales of $4.5 billion by the year 2020. Our pre-clinical studies have shown that RES-529 is able to inhibit the growth of glioblastomas. RES-529 permeates the blood brain barrier and in pre-clinical experiments, it has achieved therapeutic concentrations in both the brain and tumor, an impediment to a number of potential therapeutics. Based on this data, we applied for and have been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) which provides both tax and exclusivity benefits. We are quite excited at the opportunity to develop a therapeutic in a significant unmet medical need and have a Phase I/II trial planned for 2016 to assess the maximum tolerated dose (MTD) and efficacy in GBM patients. Once an MTD is identified in glioblastoma, we plan additional oncology clinical trials in other cancers including breast, prostate and lung cancer.
Our other product currently under development is RES-440, a first-in-class "soft" anti-androgen for acne vulgaris. Acne vulgaris is a unique opportunity for us, as there is a substantial demand for effective therapies and according to Defined Health, the overall market has sales in excess of $2 billion. RES-440 has been validated in animal models, showing potent anti-androgenic activity locally, with no systemic effects. We are planning to conduct studies throughout 2015 to enable an investigational new drug (IND) application submission to the FDA in 2016, and at which point, initiate the Phase I/II safety and efficacy clinical trials.
As of December 31, 2014, we are well capitalized, with approximately $22 million in cash and cash equivalents and have no debt. Our private placement financing in 2014 raised approximately $35.6 million in gross proceeds and approximately $31.9 million in net proceeds, after paying placement agent fees and commission and offering expenses. We anticipate that our cash and cash equivalents will be sufficient to fund our operations well into 2016.
The emphasis of this past year for RestorGenex has been pipeline development. We remain focused on our goals and on our anticipated milestones and we continue to rigorously evaluate our pipeline to leverage the best opportunities to increase value. We look forward to continuing to build stockholder value in the remainder of 2015 and 2016 by implementing our development plans and initiating the three Phase I/II clinical trials for oral RES-529 for GBM, subconjunctival RES-529 for wet AMD, and topical application of RES-440 for acne vulgaris.
We wish to thank our employees for their commitment and our stockholders for your continued investment, confidence and support.
|Stephen M. Simes|
|Chief Executive Officer|
About RestorGenex Corporation
RestorGenex is a specialty biopharmaceutical company focused on developing a portfolio of first-in-class therapeutic products to treat diseases across the ophthalmologic, oncologic and dermatologic space. RestorGenex's lead product is a novel PI3K/Akt/mTOR pathway inhibitor which has completed two Phase I clinical trials for age-related macular degeneration and is in pre-clinical development for glioblastoma multiforme. The current pipeline also includes a "soft" anti-androgen compound for the treatment of acne vulgaris. RestorGenex's novel inhibition of the PI3K pathway and unique targeting of the androgen receptor show promise in a number of additional diseases, which the Company is evaluating for the purpose of creating safe and effective treatments and innovative therapies. For additional information please see: www.restorgenex.com.
Forward Looking Statements
Certain statements in this release are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about RestorGenex's plans to focus its initial development efforts on RES-529 and RES-440 (for dermatology), its anticipated clinical work in 2015 and 2016, potential benefits and market sizes for its product candidates and its anticipated future research and development expenses and other statements that are not historical in nature, particularly those that utilize terminology such as "plans," "anticipates," "will," "proposed," "may," "expects," "believes," "future," "continue," "look forward," "show promise," other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Risks and uncertainties may cause RestorGenex's actual results to be materially different than those expressed in or implied by such forward-looking statements. Particular risks and uncertainties include, among others, uncertainties involved in clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, RestorGenex's ability to license out its existing products and technologies and license in additional products and technologies and the terms of such licenses; and other risks and uncertainties described in RestorGenex's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K for the fiscal year ended December 31, 2014 filed on April 3, 2015 with the SEC. All forward-looking statements in this release speak only as of the date of this release and are based on RestorGenex's current beliefs and expectations. RestorGenex undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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