Sol-Gel Technologies Announces 50% Enrollment in Pivotal Phase III TWIN Program for the Treatment of Acne Vulgaris

Patient enrollment of the pivotal Phase III TWIN clinical trials is on schedule

Top–line results expected in the fourth quarter of 2019

NESS ZIONA, Israel, April 15, 2019 (GLOBE NEWSWIRE) — Sol–Gel Technologies Ltd. (NASDAQ: SLGL) ("Sol–Gel" or the "Company"), a clinical–stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, announced today that it has completed enrollment of half of the patients in its pivotal Phase III clinical trials of TWIN in subjects with acne vulgaris. TWIN is a once daily topical cream containing a fixed–dose combination of encapsulated benzoyl peroxide and encapsulated tretinoin using Sol–Gel's proprietary microencapsulation platform.

"We have reached another important milestone for the company as patient enrollment for the TWIN Phase III program has progressed well, reinforcing the need for a new treatment option for acne vulgaris containing a safe and efficacious combination of encapsulated benzoyl peroxide and encapsulated tretinoin," commented Dr. Alon Seri–Levy, Chief Executive Officer of Sol–Gel. "Based on the current rate of enrollment, we plan to report top–line results in the fourth quarter of 2019."

The program consists of two randomized, double–blind, vehicle–controlled Phase III clinical trials. Each pivotal trial is planned to enroll approximately 420 subjects aged 9 and above at a 2:1 ratio, with a power of 99%. The objective of the study is to evaluate the efficacy and safety of TWIN, a topical cream containing encapsulated benzoyl peroxide and encapsulated tretinoin, compared to a vehicle when applied once daily for 12 weeks in patients with moderate–to–severe acne vulgaris.

The pivotal TWIN clinical program is being executed under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The SPA reflects FDA's agreement that the protocol design, primary endpoints and statistical analysis approach for Sol–Gel's Phase III program evaluating TWIN for the treatment of patients with acne vulgaris are acceptable to support a future New Drug Application (NDA) filing for marketing approval.

About TWIN

TWIN is a novel non–antibiotic topical cream for the treatment of acne vulgaris that is designed to be tolerable and highly effective. TWIN is the first acne treatment that contains a fixed–dose combination of encapsulated benzoyl peroxide and encapsulated tretinoin, which are separately encapsulated in silica using our proprietary technology. Tretinoin and benzoyl peroxide are widely believed to be effective as a combination treatment for acne. The silica microcapsule protects tretinoin from oxidative decomposition by benzoyl peroxide, thereby enhancing the stability and shelf–life of the product. The silica shell also creates a barrier between the drug substances and the skin and, as a result, is expected to reduce irritation typically associated with topical application of benzoyl peroxide and tretinoin, thereby increasing the tolerability of TWIN on acne–affected skin.

About Acne Vulgaris

Acne vulgaris is a common multifactorial skin disease that according to the American Academy of Dermatology affects approximately 40 to 50 million people in the United States. The disease occurs most frequently during childhood and adolescence (affecting 80% to 85% of all adolescents) but it may also appear in adults. Acne patients suffer from the appearance of lesions on areas of the body with a large concentration of oil glands, such as the face, chest, neck and back. These lesions can be inflamed (papules, pustules, nodules) or non–inflamed (comedones). Acne can have a profound effect on the quality of life of those suffering from the disease. In addition to carrying a substantial risk of permanent facial scarring, the appearance of lesions may cause psychological strain, social withdrawal and lowered self–esteem.

About Sol–Gel Technologies

Sol–Gel is a clinical–stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol–Gel's current product candidate pipeline consists of late–stage branded product candidates that leverage our proprietary, silica–based microencapsulation technology platform, and several generic product candidates across multiple indications. For additional information, please visit www.sol–

Forward–Looking Statements
This press release contains "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward–looking statements. These forward–looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward–looking statements by terminology such as "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. Forward–looking statements are based on information we have when those statements are made or our management's current expectation, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward–looking statements. Important factors that could cause such differences include, but are not limited to: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co–development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third–party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20–F filed with the Securities and Exchange Commission ("SEC") on March 21, 2019 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. Except as required by law, we undertake no obligation to update publicly any forward–looking statements after the date of this press release to conform these statements to changes in our expectations.

For further information, please contact:
Sol–Gel Contact:
Gilad Mamlok
Chief Financial Officer

Investor Contact:
Patricia L. Bank
Westwicke Partners

ORYZON receives approval to start ETHERAL: a Phase IIa clinical trial in Alzheimer's Disease with ORY-2001

MADRID, SPAIN and CAMBRIDGE, MA—(Marketwired – April 04, 2018) – Oryzon Genomics (ISIN Code: ES0167733015) (MAD: ORY), a public clinical–stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, has announced today that it has received approval of a Clinical Trial Application (CTA), the European IND equivalent, from the Spanish Drug Agency (AEMPS) to conduct a Phase IIa clinical study with ORY–2001 in patients of Alzheimer's disease (AD). The study will be conducted in different European hospitals in Spain, and also in UK and France once the corresponding approvals from the UK and French regulatory authorities are obtained.

The study, named ETHERAL (Epigenetic THERapy in ALzheimer's Disease), is designed as a randomised, double–blind, placebo–controlled, 3–arm, 26 weeks parallel–group study to evaluate the safety and tolerability of ORY2001 in patients with mild and moderate Alzheimer's disease. The study will involve 90 patients and incorporates measurements in the different domains of the disease as secondary endpoints, including memory and behavior alterations. It will also monitor the variations of diverse, yet significant CSF biomarkers. The company is aiming to launch a twin study in the US soon with a, yet to be determined, number of additional patients.

After the safety Phase I trial carried out in 106 healthy volunteers last year, where the drug proved to be safe and well tolerated under the conditions of the study and where CNS penetrance was established the investigational drug was ready to start trials in the patient population. The company has already started a Phase IIa clinical study with ORY–2001 in patients of Multiple Sclerosis (MS). The study, named SATEEN, is currently being conducted in nine Spanish hospitals, and is designed as a randomised, double–blind, placebo–controlled, 3–arm, 36 weeks parallel–group study to evaluate the safety and tolerability of ORY–2001 in patients with Relapsing–Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS). The FPI was enrolled in January and the recruitment is proceeding.

ORY–2001 is an oral and brain penetrant drug that selectively inhibits LSD1 and MAOB. The molecule acts on several levels, reduces cognitive impairment, memory loss and neuroinflammation, and at the same time has neuroprotective effects. The company has recently reported in several scientific conferences that ORY–2001 exerts a holistic action on different types of alterations also seen in patients with AD and other neurodegenerative disorders. ORY–2001 may act as a disease modifying drug. In AD patients and other neurodegenerative disorders, cognitive deterioration is often accompanied by episodes of agitation, aggression, psychosis, apathy and depression. In preclinical studies, ORY–2001 not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer's disease, to normal levels and also reduces social avoidance in rat models maintained in isolation. In addition, ORY–2001 exhibits fast, strong and durable efficacy in several preclinical models of MS.

Roger Bullock, Oryzon's Chief Medical Officer, commented, “The approval of ETHERAL, the first Phase IIa clinical trial for an epigenetic agent in AD, represents an important milestone for the company and the scientific community. Preclinical studies validate the potential of ORY–2001 to treat cognitive defects and neuroinflammation by increasing the plasticity and functionality of neurons. This is the first step in exploring this novel approach and we have chosen to study this in mild to moderate AD patients where we believe there is still physiological room to make a significant therapeutic intervention, as this is a patient population that is underserved with the conventional approaches.”

Carlos Buesa, Oryzon's President and Chief Executive Officer, commented, “ORY–2001 is a molecule with disease modifying potential that acts on different domains that are presented in AD patients. We have identified CSF biomarkers altered in AD that can be modulated by ORY–2001 and whose evolution will be monitored. This opens an important range of possibilities not only for a better understanding of the biology of the disease but also in terms of regulatory development for the drug. We expect to be able soon to start further exploratory studies and we keep committed to explore this epigenetic approach in other neurodegenerative disorders.”

About Oryzon
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. The company has one of the strongest portfolios in the field. Oryzon's LSD1 program has resulted in + 20 patent families and has rendered two compounds in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. The company has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurodegenerative diseases. Oryzon's strategy is to develop first in class compounds against novel epigenetic targets through Phase II clinical trials, at which point it is decided on a case by–case basis to either keep the development in–house or to partner or outlicense the compound for late stage development and commercialization. The company has offices in Spain and USA. For more information, visit


This communication contains forward–looking information and statements about Oryzon Genomics, S.A., including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward–looking statements are statements that are not historical facts and are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates” and similar expressions. Although Oryzon Genomics, S.A. believes that the expectations reflected in such forward–looking statements are reasonable, investors and holders of Oryzon Genomics, S.A. shares are cautioned that forward–looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon Genomics, S.A., that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward–looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon Genomics, S.A. to the Comisión Nacional del Mercado de Valores, which are accessible to the public. Forward–looking statements are not guarantees of future performance. The auditors of Oryzon Genomics, S.A, have not reviewed them. You are cautioned not to place undue reliance on the forward–looking statements, which speak only as of the date they were made. All subsequent oral or written forward–looking statements attributable to Oryzon Genomics, S.A. or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward–looking statements included herein are based on information available to Oryzon Genomics, S.A. on the date hereof. Except as required by applicable law, Oryzon Genomics, S.A. does not undertake any obligation to publicly update or revise any forward–looking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States. The Company's securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of the Company's securities to be made in the United States will be made by means of a prospectus that may be obtained from the Company or the selling security holder, as applicable, that will contain detailed information about the Company and management, as well as financial statements.

Advanzeon Solutions, Inc.'s Wholly-Owned Subsidiary, Pharmacy Value Management Solutions, Inc. Enters Into Agreement With T A Baxter, LLC

TAMPA, FL—(Marketwired – March 26, 2018) – Advanzeon Solutions, Inc. (OTCBB: CHCR) (“Advanzeon”) announced today that its wholly–owned subsidiary, Pharmacy Value Management Solutions, Inc. (“PVMS”) has entered into an Agreement with T A Baxter, LLC (“Baxter”), a specialty pharmaceutical company specializing in CDC compliant opioid pain medication, commercially known as “LoMed.” As a precondition to prescribing LoMed, the patient must first be examined for sleep apnea. PVMS' SleepMaster Solutions™ (“SMS”) program has been designated as the exclusive sleep apnea testing provider for all patients being prescribed the LoMed medication. This designation is worldwide and effective immediately.

Warren Melick, Vice President of Sales and Marketing for Baxter, stated, “Recognizing the 77 million people suffering from chronic, non–cancer pain who are systematically being denied the opioid pain relief that has allowed them to cope for years, my partners and I created T A Baxter, LLC. The company was created and founded solely for the purpose of addressing the conundrum of physicians prescribing pain relief and maintaining their compliance with the CDC and DEA guidelines. Addressing the opioid epidemic consuming our nation, the CDC has implanted restrictions on opioids that eliminate the clear majority of options available to physicians. The LoMed products represents the first pain relief program designed to implement precision, personalized tools maximizing patient safety, while giving physicians the tools needed to individualize pain therapy based upon the patient's ability to avoid respiratory depression, consider their genetic ability to metabolize drugs and ensure there are no conflicting drugs in the patient's system. Critical to the prescribing of LoMed is the need for an in–home sleep study to determine risk of respiratory depression, and whether or not any of the components of LoMed are contraindicated should the patient have sleep apnea.”

Mr. Melick continued, “Our marketing program is underway, and we expect LoMed to be available in all 50 states by the end of April 2018. Reception has been strong among the professional community and the Taft Hartley self–funded Labor unions. We are delighted to have been successful in entering into a long–term contractual relationship with PVMS, whereby its SMS program becomes our exclusive provider for sleep apnea testing of all patients being prescribed our LoMed product. The SMS program is directed by physicians, available in all 50 states and, in our estimation, provides the most complete sleep apnea program in the country. We are looking forward to a long and successful relationship with PVMS. We are confident that our LoMed program will allow patients suffering with chronic non–cancer pain to receive the 24–pain relief they require while allowing the physicians to avoid the inappropriate scrutiny of the DEA. These patients are already suffering with the stigma of life with chronic pain and often being falsely labeled as addicts.”

Clark A. Marcus, CEO of PVMS, stated, “We, at PVMS, are thrilled to have been selected by Baxter to support its LoMed program. Recognizing that all opioids may create a respiratory depression, a critical component of the LoMed program is the predetermination of whether, in each instance, the patient suffers from sleep apnea. As the national leader in this field, Baxter has contracted with us to provide this critical component and perform sleep apnea testing for each patient prior to providing that patient with a prescription for its LoMed product. By working with Baxter, we are confident that we will be bringing about a widespread change in the professional norms currently existing for treating chronic pain. Being part of that change is a cornerstone of our company, and we are proud to be a part of this program.”

About Advanzeon Solutions, Inc.

Established in 1969, Advanzeon, through its subsidiaries, owns and operates the nation's most complete sleep apnea program known as SleepMaster Solutions™. Headquartered in Tampa, Florida, the Company's Program is available in all fifty states, Washington D.C. and Puerto Rico. The Program focuses on personalized attention, flexibility, a commitment to high–quality services and innovative approaches that address both the specific needs of clients and changing healthcare industry demands. For more information, visit our website at

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This press release contains forward–looking statements that are subject to risks and uncertainties. These forward–looking statements include information about possible or assumed future results of our business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward–looking statements by words such as “may,” “should,” “plan,” “intend,” “potential,” “continue,” “believe,” “expect,” “predict,” “anticipate” and “estimate,” the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward–looking statements. The forward–looking statements are qualified by their terms and/or important factors, many of which are outside the Company's control, involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made. The forward–looking statements are based on the Company's beliefs, assumptions and expectations of our future performance, taking into account information currently available to the Company. These beliefs, assumptions and expectations can change as a result of many possible events or factors, not all of which are known to the Company. Neither the Company nor any other person assumes responsibility for the accuracy or completeness of these statements. The Company will update the information in this press release only to the extent required under applicable securities laws. If a change occurs, the Company's business, financial condition, liquidity and results of operations may vary materially from those expressed in the aforementioned forward–looking statements.