Sol-Gel Technologies Reports First Quarter 2020 Financial Results and Corporate Update
- New Drug Applications for Epsolay® and Twyneo® remain on track for the second quarter and second half 2020, respectively
- Completed a
$23 millionunderwritten public offering in February with an additional $5 millioninvestment from Sol-Gel’s controlling shareholder in April, providing cash runway into mid-2021 and funds pre-commercialization efforts for Epsolay and Twyneo
- Top-line generic product revenue of
$3.4 millionin first quarter 2020
“In the first quarter of 2020, we strengthened our balance sheet through a
“I also want to acknowledge the efforts of our employees and the whole healthcare system in working to keep our community safe during the ongoing COVID-19 pandemic,” continued Dr. Seri-Levy. “At Sol-Gel, we have been fortunate to have seen only minimal impact to our operations to date, largely due to the advanced clinical status of our two lead programs, Epsolay and Twyneo.”
Corporate Highlights and Recent Developments
- Strengthened balance sheet with
$28.0 millionin gross proceeds from the February underwritten public offering of $23.0 millionand from the $5.0 millionthat Sol-Gel’s controlling shareholder, M. Arkin Dermatology Ltd., invested in April. Despite market conditions, the April purchase of ordinary shares and warrants was at the same terms as the February underwritten public offering, $11.00per ordinary share and an accompanying warrant to purchase 0.80 of an ordinary share. The warrants have an initial exercise price of $14.00per share, subject to certain adjustments, and will expire on February 19, 2023.
- In the first quarter of 2020,
Sol-Gelgenerated revenue of $3.4 millionfrom its collaboration agreement with Perrigo.
- In response to COVID-19,
Sol-Gelimmediately implemented policies and procedures to protect the health, safety and welfare of employees and their families and to help mitigate the spread of the coronavirus including mandatory work-from-home and frequent on-site sterilization.
Clinical Program Updates
Sol-Gelexpects to file an NDA for Epsolay (encapsulated benzoyl peroxide, 5%, cream) in the second quarter of 2020. If approved, Epsolay has the potential to be the first FDA-approved single-agent BPO prescription drug product and to redefine the standard of care for the treatment of inflammatory lesions associated with rosacea. Sol-Gelexpects to file an NDA for Twyneo (encapsulated benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream) in the second half of 2020. If approved, Twyneo has the potential to become a preferred treatment for acne.
- In January,
Sol-Gelannounced positive topline results from an open-label long-term safety study of Epsolay. Of the 209 patients (57.6%) that completed 52 weeks of treatment with Epsolay, 153 (73.2%) reached “clear” or “almost clear”, 46 (22%) reached “mild” rosacea, only 10 (4.8%) had “moderate” rosacea, and none had “severe” rosacea on a Global Assessment (IGA) 5-point scale. Additionally, at the end of the study, more than 90% of these patients had “none” or “mild” cutaneous signs or symptoms (burning or stinging, itching, dryness and scaling) and no “severe” scores were recorded.
- A proof of concept clinical study of SGT-210, erlotinib gel, a topical epidermal growth factor receptor inhibitor, for the potential treatment of punctuate palmoplantar keratoderma type 1 initiated in
January 2020. This clinical study was recently expanded to include other types of palmoplantar keratoderma. Patient enrollment is expected to be renewed subject to Israel Ministry of Healthguidelines for COVID-19. Data is expected in 2021.
- In early 2020,
Sol-Geladded to its pre-clinical pipeline tapinarof, an aryl hydrocarbon receptor agonist, and roflumilast, a PDE4 inhibitor, each to be developed for potential treatment of psoriasis, as mono or combination therapies and other dermatological indications. Sol-Gelcontinues to work to advance these assets into the clinic.
Financial Results for the Three Months ended
Revenue in the first quarter 2020 was
Research and development expenses were
General and administrative expenses were
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 leverages its proprietary microencapsulation technology platform for Twyneo, for the treatment of acne vulgaris, and Epsolay, for the treatment of papulopustular rosacea. The Company’s pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, for the treatment of punctate palmoplantar keratoderma, and preclinical assets tapinarof and roflumilast. For additional information, please visit www.sol-gel.com.
Epsolay® is an investigational topical cream containing encapsulated benzoyl peroxide, 5%, for the treatment of papulopustular rosacea. Epsolay utilizes a patented technology process to encapsulate benzoyl peroxide within silica microcapsules to create a barrier between the medication and the skin. The slow migration of medication from the microcapsules delivers treatment doses onto the skin, while the barrier reduces the ability of benzoyl peroxide to induce the strong oxidation process that can result in significant skin irritation, such as erythema, burning and stinging. Silica is chemically inert, photochemically and physically stable, and is safely used in topical products. If approved, Epsolay has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product.
About Papulopustular Rosacea
Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans. The condition is common, especially in fair-skinned people of Celtic and northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin or forehead. If left untreated, rosacea can slowly worsen over time. As the condition progresses the redness becomes more persistent, blood vessels become visible and pimples often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.
Twyneo is an investigational, antibiotic-free, fixed-dose combination of encapsulated benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream for the treatment of acne vulgaris. If approved, it will be the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin, which are separately encapsulated in silica using
About Acne Vulgaris
Acne vulgaris is a common multifactorial skin disease that according to the
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, including, but not limited to, statements regarding the progress of our product candidates, the timing of the submission of an NDA for Epsolay and an NDA for Twyneo, and the Company’s expectations regarding its liquidity and ability to fund operational and capital expenditure requirements. 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, risks relating to the effects of COVID-19 (coronavirus), the timing of a launch of a branded tapinarof product and the launch of a branded topical roflumilast in the
CONSOLIDATED BALANCE SHEETS
|A s s e t s|
|Cash and cash equivalents||$||9,412||$||2,199|
|Receivables from collaborative arrangements||4,120||3,594|
|Prepaid expenses and other current assets||1,293||863|
|TOTAL CURRENT ASSETS||55,791||70,618|
|Restricted long-term deposits||472||1,268|
|Property and equipment, net||2,314||2,363|
|Operating lease right-of-use assets||2,040||1,904|
|Funds in respect of employee rights upon retirement||684||663|
|TOTAL NON-CURRENT ASSETS||5,510||6,198|
|Liabilities and shareholders' equity|
|Other accounts payable||4,123
|Current maturities of operating leases||672
|TOTAL CURRENT LIABILITIES||6,505||7,423|
|LONG-TERM LIABILITIES -|
|Operating leases liabilities||1,373
|Liability for employee rights upon retirement||958
|TOTAL LONG-TERM LIABILITIES||2,331
|Additional paid-in capital||203,977
|TOTAL SHAREHOLDERS' EQUITY||52,465
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||61,303
CONSOLIDATED STATEMENTS OF OPERATIONS
|Three months ended
|Research and Development||10,793||7,930|
|General and Administrative||1,694||2,761|
|TOTAL OPERATING LOSS||$||6,129||$||7,226|
|FINANCIAL INCOME, net||(401||)||(116||)|
|LOSS BEFORE INCOME TAXES||$||5,728||$||7,110|
|LOSS FOR THE PERIOD||$||5,728||$||7,110|
|BASIC AND DILUTED LOSS PER ORDINARY SHARE||$||0.30||$||0.33|
|WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE||18,949,968||21,361,514|
For further information, please contact:
Chief Financial Officer
Source: Sol-Gel Technologies Ltd.