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–gel.com.

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
+972–8–9313433

Investor Contact:
Patricia L. Bank
Westwicke Partners
+1–415–513–1284
patti.bank@westwicke.com

Twelve Seas Investment Company Signs Agreement to Combine with a UAE Company

NEW YORK, NY, April 15, 2019 (GLOBE NEWSWIRE) — Twelve Seas Investment Company (“Twelve Seas”) (previously NASDAQ:TWLV and currently NASDAQ:BROG), a company formed for the purpose of entering into a business combination, and a United Arab Emirates (UAE) company in the oil storage and services business, announced they have executed today a business combination agreement (“BC Agreement”).

Pursuant to the BC Agreement, Twelve Seas will engage in a merger involving a newly formed Cayman Islands holding company and the combined company (referred to herein together as Twelve Seas) will acquire 100% of the issued and outstanding shares of the UAE company in a transaction valued at approximately $1 billion (the “Transaction”). In the Transaction, the UAE company will become a wholly–owned subsidiary of Twelve Seas, and the post–transaction business of the combined company will be that of the UAE company. Twelve Seas expects the Transaction to close at the end of the second quarter 2019 or early third quarter of 2019, subject to certain closing conditions. One significant closing condition requires that Twelve Seas will have net cash proceeds at closing (after payment of expenses and redemptions from Twelve Seas’ trust account), including any proceeds of any new equity financings (“Closing Proceeds”), in excess of $125 million. In addition, the Transaction closing is subject to the approval of the shareholders of Twelve Seas and the shareholders of the UAE company, as well as certain other third parties.

Pursuant to the BC Agreement, the shareholders of the UAE company will sell 100% of its equity interests to Twelve Seas in exchange for total consideration of 100.0 million Twelve Seas ordinary shares, provided that at the election of the UAE company, up to 40% of the Closing Proceeds may be paid as cash consideration instead of Twelve Seas shares. All cash remaining in Twelve Seas at the closing of the Transaction is expected to be used for the UAE company’s growth. If no Twelve Seas shareholders elect to redeem their shares, and there is no election by the UAE company for cash consideration in lieu of shares, then current shareholders of the UAE company will hold approximately 78% of the issued and outstanding shares, and current shareholders of Twelve Seas will hold approximately 22% of the issued and outstanding shares. A total of 20.0 million of the 100.0 million ordinary shares being issued to the UAE company shareholders will be placed into escrow and subject to release upon the UAE company satisfying certain milestones.

The UAE company, Brooge Petroleum and Gas Investment Company (“BPGIC”), was founded in 2013 to capitalize on an anticipated need for oil storage capacity at the Port of Fujairah, in the UAE, which was anticipated to become an important oil hub. Today, the Port of Fujairah is one of the most attractive storage hubs and a key strategic trading node globally. Twelve Seas’ management believes that BPGlC’s award winning state–of–the–art terminals offer the industry’s most advanced technologies, ensuring the highest level of service to clients. BPGIC is developing terminals in phases and aims to have a total capacity of 1 million m^3 following the scheduled completion of the second phase of construction by late Q2 or early Q3 in 2020.

Following the closing of the Transaction, BPGIC will continue to be led by its current management team with Mr. Nicolaas Paardenkooper as Chief Executive Officer, Miss. Lina Saheb, as Chief Strategy Officer, and Faisal El Selim as Chief Marketing Officer. BPGIC will remain headquartered in Fujairah, UAE.

Mr. Bryant Edwards, COO and Director of Twelve Seas, said, “This transaction represents an exciting opportunity for foreign public investors, and specifically those that invest in Nasdaq company stocks, to invest directly into the dynamic and growing oil and gas infrastructure sector within the UAE. Today’s announcement comes less than two months after the investment by the global investment firms of KKR and Blackrock, who purchased cash flow streams derived from national pipelines in the UAE. Through BPGIC’s NASDAQ listing, investors can have a direct ownership interest in an exciting company with exposure to the same growing oil and gas infrastructure in the UAE.”

Mr. Nicolaas Paardenkooper, CEO of BPGIC commented, “We are excited to enter into this agreement with Twelve Seas as it provides us with the ability to enter the US capital markets and provide this unique opportunity to investors globally. The US capital markets are the largest in the world and include sophisticated investors with large investments in similar public companies within our industry. We look forward to the opportunity to demonstrate our industry leading operations in the emerging global hub for oil at the Port of Fujairah in the UAE. This transaction enables BPGIC to continue its exciting growth and accelerate future opportunities.”

Key Transaction Terms and Details

Pursuant to the BC Agreement, Twelve Seas will merge with a newly formed Cayman Islands merger subsidiary of Brooge Holdings Limited, a newly formed Cayman Islands holding company (“Pubco”), pursuant to which the Twelve Seas securityholders will receive substantially identical securities of Pubco in the merger and Twelve Seas will become a wholly–owned subsidiary of Pubco, and simultaneously Pubco will acquire 100% of the issued and outstanding shares of BPGIC. It is expected that 100% of the transaction consideration will be newly issued ordinary shares of Pubco, except to the extent BPGIC exercises its right to elect for BPGIC shareholders to receive up to 40% of the Closing Proceeds in cash, in lieu of shares. All remaining Closing Proceeds are expected to be used for BPGIC’s internal growth. Upon closing of the transaction, BPGIC shareholders will receive approximately 100.0 million in shares as consideration (unless BPGIC makes the cash consideration election), with 20.0 million thereof placed into escrow and subject to achievement of certain milestones to be mutually agreed to.

Advisors

EarlyBirdCapital, Inc. is acting as exclusive financial and capital markets advisor to Twelve Seas Investment Company and Ellenoff Grossman & Schole LLP is acting as its legal advisors.

K&L Gates is acting as legal advisors to BPGIC.

Maples & Calder is acting as Cayman Islands legal counsel for the transaction.

About Twelve Seas Investment Company

Twelve Seas Investment Company is a blank check company formed for the purpose of entering into a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization or other similar business combination with one or more businesses or entities.

Twelve Seas Investment Company is led by Chairman Neil Richardson, Chief Executive Officer Dimitri Elkin, Chief Operating Officer Bryant B. Edwards, President Stephen A. Vogel, and Chief Financial Officer Stephen N. Cannon.

About Brooge Petroleum and Gas Investment Company

Established in 2013, BPGIC is an independent oil storage provider, strategically located in the Emirate of Fujairah within the UAE. The Port of Fujairah is one of the most attractive storage hubs and a key strategic trading node globally. BPGlC's terminals are award winning state–of–the–art facilities and offer the industry’s most advanced technologies, ensuring the highest level of service to clients.

BPGIC’s current terminal is located at a prime location in close proximity to the Port of Fujairah’s berth connection points. BPGIC is developing terminals in phases and aims to have a total capacity of 1 million m^3 following the completion of the second phase of construction. Phase I commenced operations in January 2018 with 0.4 million m^3 of capacity. The terminals are capable of storing fuel oil and clean products. Phase II is currently under construction and expected to be operational in late Q2 or early Q3 in 2020. Upon completion of Phase II, there will be total capacity of 0.6 million m^3, and capability to store crude oil, fuel oil and clean products. The design of Phase II will enable efficient loading and unloading of VLCC vessels (very large crude carriers).

The Company also focuses on value added services to its customers including: Blending, Heating, Inter–bank transfer and throughput transfer. BPGIC is fully compliant with current environmental standards. Since commencement of operations, BPGIC has had an impeccable safety and environmental track record. BPGIC is ISO 9001, ISO 14001 and OHSAS 18001 certified and is IMO 2020 compliant.

Forward–Looking Statements

This press release contains, and certain oral statements made by representatives of Twelve Seas, BPGIC, Pubco and their respective affiliates, from time to time may contain, “forward–looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Twelve Seas's, BPGIC's and Pubco’s actual results may differ from their expectations, estimates and projections and consequently, you should not rely on these forward–looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “might” and “continues,” and similar expressions are intended to identify such forward–looking statements. These forward–looking statements include, without limitation, Twelve Seas's, BPGIC's and Pubco’s expectations with respect to future performance and anticipated financial impacts of the Transaction, the satisfaction of the closing conditions to the Transaction and the timing of the completion of the Transaction. These forward–looking statements involve significant risks and uncertainties that could cause actual results to differ materially from expected results. Most of these factors are outside the control of Twelve Seas, BPGIC or Pubco and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of BC Agreement; (2) the inability to complete the BC Agreement, including due to failure to obtain approval of the shareholders of Twelve Seas or other conditions to closing in the Transaction agreement; (3) delays in obtaining or the inability to obtain any necessary regulatory approvals required to complete the transactions contemplated by the BC Agreement; (4) the inability to obtain or maintain the listing of the post–acquisition company's ordinary shares on NASDAQ following the Transaction; (5) the risk that the Transaction disrupts current plans and operations as a result of the announcement and consummation of the Transaction; (6) the ability to recognize the anticipated benefits of the Transaction, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably and retain its key employees; (7) costs related to the Transaction; (8) changes in applicable laws or regulations; (9) the possibility that BPGIC, Pubco or the combined company may be adversely affected by other economic, business, and/or competitive factors; and (10) other risks and uncertainties to be identified in Twelve Seas's and Pubco’s proxy statement (when available) relating to the Transaction, including those under “Risk Factors” therein, and in other filings with the Securities and Exchange Commission (“SEC”) made by Twelve Seas, BPGIC and Pubco. Twelve Seas, BPGIC and Pubco caution that the foregoing list of factors is not exclusive. Twelve Seas, BPGIC and Pubco caution readers not to place undue reliance upon any forward–looking statements, which speak only as of the date made. None of Twelve Seas, BPGIC or Pubco undertakes or accepts any obligation or undertaking to release publicly any updates or revisions to any forward–looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law.

No Offer or Solicitation

This press release is for informational purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy any securities pursuant to the proposed transactions or otherwise, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

No Assurances

There can be no assurance that the proposed Transaction will be completed, nor can there be any assurance, if the Transaction is completed, that the potential benefits of combining the companies will be realized. The description of the Transaction contained herein is only a summary and is qualified in its entirety by reference to the definitive agreements relating to the Transaction, copies of which will be filed by Twelve Seas with the Securities and Exchange Commission (the “SEC”) as an exhibit to a Current Report on Form 8–K.

Additional Information and Where to Find It

In connection with the transaction described herein, Twelve Seas will file relevant materials with the SEC, including a proxy statement on Schedule 14A. Promptly after filing its definitive proxy statement with the SEC, Twelve Seas will mail the definitive proxy statement and a proxy card to each shareholder entitled to vote at the special meeting relating to the Transaction. INVESTORS AND SECURITY HOLDERS OF TWELVE SEAS ARE URGED TO READ THESE MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION WITH THE TRANSACTION THAT TWELVE SEAS WILL FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT TWELVE SEAS, BPGIC AND THE TRANSACTION. The preliminary proxy statement, the definitive proxy statement and other relevant materials in connection with the transaction (when they become available), and any other documents filed by Twelve Seas with the SEC, may be obtained free of charge at the SEC’s website (www.sec.gov) or by writing to Twelve Seas Investment Company at 135 E 57th St. 18th Floor, New York, New York 10022.

Participants in Solicitation

Twelve Seas, BPGIC, Pubco and their respective directors, executive officers and employees and other persons may be deemed to be participants in the solicitation of proxies from the holders of Twelve Seas ordinary shares in respect of the proposed Transaction. Information about Twelve Seas’s directors and executive officers and their ownership of Twelve Seas’s ordinary shares is set forth in Twelve Seas Investment Company’s Annual Report on Form 10–K for the year ended December 31, 2018 filed with the SEC, as modified or supplemented by any Form 3 or Form 4 filed with the SEC since the date of such filing. Other information regarding the interests of the participants in the proxy solicitation will be included in the proxy statement pertaining to the proposed Transaction when it becomes available. These documents can be obtained free of charge from the sources indicated above.

For investor and media inquiries, please contact:

Investor Relations
The Equity Group Inc.
Fred Buonocore – (212) 836–9607 / fbuonocore@equityny.com
Kevin Towle – (212) 836–9620 / ktowle@equityny.com

Stephen N Cannon
Chief Financial Officer
Twelve Seas Investment Company
Email: info@twelveseascapital.com

SOURCE Twelve Seas Investment Company