<SEC-DOCUMENT>0001178913-23-003816.txt : 20231130
<SEC-HEADER>0001178913-23-003816.hdr.sgml : 20231130
<ACCEPTANCE-DATETIME>20231130071012
ACCESSION NUMBER:		0001178913-23-003816
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20231130
FILED AS OF DATE:		20231130
DATE AS OF CHANGE:		20231130

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Sol-Gel Technologies Ltd.
		CENTRAL INDEX KEY:			0001684693
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-38367
		FILM NUMBER:		231453961

	BUSINESS ADDRESS:	
		STREET 1:		7 GOLDA MEIR ST.
		STREET 2:		WEIZMANN SCIENCE PARK
		CITY:			NESS ZIONA
		STATE:			L3
		ZIP:			7403648
		BUSINESS PHONE:		97289313433

	MAIL ADDRESS:	
		STREET 1:		7 GOLDA MEIR ST.
		STREET 2:		WEIZMANN SCIENCE PARK
		CITY:			NESS ZIONA
		STATE:			L3
		ZIP:			7403648
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>zk2330616.htm
<DESCRIPTION>6-K
<TEXT>
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      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Washington, D.C. 20549</div>
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      <div style="line-height: 1.25;">&#160;</div>
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    <div style="line-height: 1.25; background-color: rgb(255, 255, 255); font-weight: bold; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-style: normal; font-variant: normal; text-transform: none;">
      <div style="text-align: center; line-height: 1.25;">FORM&#160;6-K</div>
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    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">&#160;</div>
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    <div style="line-height: 1.25;">
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Report of Foreign Private Issuer</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Pursuant to Rule&#160;13a-16&#160;or&#160;15d-16</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Under the Securities Exchange Act of 1934</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">&#160;</div>
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    <div style="line-height: 1.25;">
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">For the month of November 2023</div>
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    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">&#160;</div>
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    <div style="line-height: 1.25;">
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Commission File Number 001-38367</div>
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    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">&#160;</div>
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    <div style="line-height: 1.25;">
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">SOL-GEL TECHNOLOGIES LTD.</div>
      <div style="text-align: center; line-height: 1.25;">(Translation of registrant&#8217;s name into English)</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">&#160;</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">7 Golda Meir Street</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Ness Ziona 7403650, Israel</div>
      <div style="text-align: center; line-height: 1.25;">(Address of principal executive offices)</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">&#160;</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-indent: 24.5pt; line-height: 1.25;">Indicate by check mark whether the registrant files or will file annual reports under cover Form&#160;20-F&#160;or Form&#160;40-F.</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">&#160;</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: center; line-height: 1.25;">Form&#160;20-F <font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9746;</font>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;Form&#160;40-F&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9744;</font></div>
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">&#160;</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-indent: 24.5pt; line-height: 1.25;">Indicate by check mark if the registrant is submitting the Form&#160;6-K&#160;in paper as permitted by Regulation&#160;S-T&#160;Rule
        101(b)(1):&#160;&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9744;</font></div>
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    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">&#160;</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-indent: 24.5pt; line-height: 1.25;">Indicate by check mark if the registrant is submitting the Form&#160;6-K&#160;in paper as permitted by Regulation&#160;S-T&#160;Rule
        101(b)(7):&#160;&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9744;</font></div>
      <div style="text-indent: 24.5pt; line-height: 1.25;"><font style="font-family: 'Segoe UI Symbol', sans-serif;"> <br>
        </font></div>
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      <div style="text-align: center; line-height: 1.25; font-weight: bold;">INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <div style="line-height: 1.25;">On November 30, 2023, Sol-Gel Technologies Ltd. (the &#8220;Company&#8221;) issued a press release entitled &#8220;Sol-Gel Technologies Screens First Patient
      for SGT-610 Phase 3 Study&#8221;.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">Attached hereto is the following exhibit:</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;"><a href="exhibit_99-1.htm">Exhibit 99.1</a>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;<a href="exhibit_99-1.htm">Press release dated November 30, 2023</a></div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">Exhibit 99.1 is hereby incorporated by reference into
        the Company's Registration Statements on Form S-8 (Registration Nos. 333-223915 and 333-270477) and its Registration Statement on Form F-3 (Registration No. 333-264190).</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25; text-align: center;">2<br style="line-height: 1.25;">
      </div>
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      </div>
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    <div style="line-height: 1.25;">
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">SIGNATURES</div>
      <div style="line-height: 1.25">&#160;</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its
        behalf by the undersigned, thereunto duly authorized.</div>
      <div style="line-height: 1.25">&#160;</div>
    </div>
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        <tr>
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            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="vertical-align: top;" colspan="2">
            <div style="line-height: 1.25; font-weight: bold;">SOL-GEL TECHNOLOGIES LTD.</div>
          </td>
        </tr>
        <tr>
          <td style="width: 50%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 4%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 46%; vertical-align: middle;">
            <div style="line-height: 1.25;"><font style="line-height: 1.25;">&#160;</font></div>
          </td>
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          <td style="width: 50%; vertical-align: top;">
            <div style="line-height: 1.25;">Date:&#160; November 30, 2023</div>
          </td>
          <td style="width: 4%; vertical-align: top;">
            <div style="line-height: 1.25;">By:</div>
          </td>
          <td style="width: 46%; vertical-align: top; border-bottom: 2px solid rgb(0, 0, 0);">
            <div style="line-height: 1.25;">/s/ Gilad Mamlok</div>
          </td>
        </tr>
        <tr>
          <td style="width: 50%; vertical-align: top;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 4%; vertical-align: top;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 46%; vertical-align: top;">
            <div style="line-height: 1.25;">Gilad Mamlok</div>
          </td>
        </tr>
        <tr>
          <td style="width: 50%; vertical-align: top;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 4%; vertical-align: top;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 46%; vertical-align: top;">
            <div style="line-height: 1.25;">Chief Financial Officer</div>
          </td>
        </tr>

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      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
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        <div style="text-align: center;">&#160;3<br style="line-height: 1.25;">
        </div>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit_99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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    <div style="text-align: right; line-height: 1.25;"><u><font style="font-weight: bold;">Exhibit 99.1</font></u><br>
    </div>
    <div style="line-height: 1.25;"><br>
    </div>
    <div style="line-height: 1.25;"><img src="image00002.jpg"></div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">Sol-Gel Technologies Screens First Patient for SGT-610 Phase 3 Study</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <table cellspacing="0" cellpadding="0" id="zfb92d7a821084739a0b1113f0f07e56a" class="DSPFListTable" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

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          <td style="width: 18pt; vertical-align: top;">&#8226;</td>
          <td style="width: auto; vertical-align: top;">
            <div style="font-style: italic;">SGT-610 has &#8220;Orphan Drug&#8221; designation status in the U.S. and E.U. and &#8220;Breakthrough Therapy&#8221; designation status in the U.S., as potentially the
              first and only therapy aimed at preventing new BCCs in Gorlin syndrome</div>
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    <table cellspacing="0" cellpadding="0" id="zeaca219ad2644290b999a0b5d335cf01" class="DSPFListTable" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

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          </td>
          <td style="width: 18pt; vertical-align: top;">&#8226;</td>
          <td style="width: auto; vertical-align: top;">
            <div><font style="font-style: italic;">Sol-Gel to host a virtual Key Opinion Leader event to discuss the
                Gorlin syndrome patient experience and treatment needs, as well as the SGT-610 Phase 3 trial on Wednesday, December 6</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">th</sup><font style="font-style: italic;"> at 12 pm ET</font></div>
          </td>
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    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">NESS ZIONA, Israel,&#160;November 30, 2023&#160;--&#160;Sol-Gel Technologies, Ltd.&#160;(Nasdaq: SLGL) (&#8220;Sol-Gel&#8221;), a dermatology company leveraging innovative
      approaches to develop pioneering treatments for patients with severe skin conditions, and with two approved large-category dermatology products, TWYNEO<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> and EPSOLAY<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>, today announced that it has begun Phase 3 testing of SGT-610
      (patidegib gel, 2%) for Gorlin syndrome with the first patient screened. SGT-610 is a new topical hedgehog inhibitor being developed to prevent the new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome that is expected to have an
      improved safety profile compared to oral hedgehog inhibitors. Patidegib was acquired by Sol-Gel from PellePharm and is currently the only therapy in development to prevent the development of new BCC lesions in Gorlin syndrome patients.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">"We are pleased to initiate patient screening in this Phase 3 trial that has been long awaited by the Gorlin syndrome patient community,&#8221;
      said Alon Seri-Levy, Ph.D., Chief Executive Officer of Sol-Gel. &#8220;To increase the probability of success of this trial we have refined screening criteria to enroll subjects with more severe disease at baseline in terms of a higher baseline number of
      facial BCC lesions. This may help to better demonstrate the preventive effect of the medication. Other insights that we are using in our Phase 3 trial design strategy are to pre-screen patients for a specific genetic mutation associated with Gorlin
      syndrome and to ease patient study compliance by reducing the number of study visits over the 12-months of treatment.&#160; We hope that our learnings to optimize this trial&#8217;s design will help Sol-Gel advance this important drug candidate to Gorlin
      syndrome patients with no approved therapies.&#8221;</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">&#8220;We anticipate SGT-610, with Orphan- and Breakthrough designation from FDA, could have a market potential of over&#160;$300 million. We look
      forward to discussing the experience of the Gorlin syndrome patient, the market opportunity for SGT-610, and the Phase 3 trial design during a Key Opinion Leader investor day that we are hosting on December 6<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">th</sup>,&#8221; added Dr. Seri-Levy.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">Sol-Gel will conduct the Phase 3 study to investigate SGT-610 in approximately 140 subjects at approximately 40 experienced clinical
      centers in North America, United Kingdom and Europe. For more information about the trial and study design, visit <u>NCT06050122</u>.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
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    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25; font-weight: bold;">Register for Sol-Gel&#8217;s KOL event</div>
    <div style="line-height: 1.25;">Sol-Gel will host a virtual KOL event featuring Julie Breneiser (Executive Director, Gorlin Syndrome Alliance)&#160;and&#160;Ervin Epstein Jr, M.D.
      (Co-Founder of PellePharm). The event will highlight the patient&#8217;s experience through the eyes of a Gorlin syndrome patient as well as discuss the therapeutic potential of SGT-610 to prevent new BCCs in Gorlin syndrome patients and Sol-Gel&#8217;s Phase 3
      trial.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">Register for the event <u>here</u>.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25; font-weight: bold;">About Gorlin Syndrome and SGT-610</div>
    <div style="line-height: 1.25;">SGT-610, a topical hedgehog signaling pathway inhibitor, has the potential to be the first ever preventive treatment for Gorlin syndrome,
      if approved. Gorlin syndrome, an autosomal dominant genetic disorder affecting approximately one in 27,000-31,000 people in the&#160;U.S., is mostly caused by inheritance of one defective copy of the tumor suppressor patched homolog 1 (PTCH1) gene.
      Normally, the PTCH1 gene blocks the smoothened, frizzle class receptor (SMO) gene, turning off the hedgehog signaling pathway when it is not needed. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow basal
      cell carcinoma (BCC) tumor cells to divide uncontrollably. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, thus, allowing cells to function normally and reducing the production of new tumors.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25; font-weight: bold;">About&#160;Sol-Gel Technologies</div>
    <div style="line-height: 1.25;">Sol-Gel Technologies, Ltd.&#160;is a dermatology company focused on identifying, developing and commercializing or partnering drug products for
      the treatment of skin diseases.&#160;Sol-Gel&#160;developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved by the FDA for the treatment of
      inflammatory lesions of rosacea in adults. Both drugs are exclusively licensed to and commercialized by Galderma in the&#160;U.S.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">The Company&#8217;s pipeline includes Orphan- and Breakthrough designated dug candidate, SGT-610, under investigation for the prevention of new
      basal cell carcinomas in Gorlin syndrome patients, and also includes topical drug candidate SGT-210 under investigation for the treatment of rare skin keratodermas.</div>
    <div style="line-height: 1.25;">For additional information, please visit&#160;www.sol-gel.com.</div>
    <div style="line-height: 1.25;"> <br>
    </div>
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    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25; font-weight: bold;">Forward-Looking Statements</div>
    <div style="line-height: 1.25;"><font style="font-style: italic;">This press release contains
        &#8220;forward-looking statements&#8221; 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, potential of SGT-610 as the first and only therapy aimed at preventing new BCCs in Gorlin syndrome; improved safety profile of SGT-610,&#160; success of the SGT-610 clinical studies, obtaining regulatory
        approval for our product candidates including SGT-610; and the market potential of SGT-610.&#160; In some cases, you can identify forward-looking statements by terminology such as &#8220;believe,&#8221; &#8220;may,&#8221; &#8220;estimate,&#8221; &#8220;continue,&#8221; &#8220;anticipate,&#8221; &#8220;intend,&#8221;
        &#8220;should,&#8221; &#8220;plan,&#8221; &#8220;expect,&#8221; &#8220;predict,&#8221; &#8220;potential,&#8221; 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&#8217;s current expectations 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, a delay in the timing of our clinical trials, the success of our clinical trials , and an increase in our anticipated costs and expenses, as well as the following factors: (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, the potential delay in receiving such regulatory approvals and the possibility of
        adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators&#8217; ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate
        protection of our intellectual property; (vii) our collaborators&#8217; ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators&#8217; 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&#160;the United States,&#160;Europe&#160;or&#160;Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and,&#160; (xvii) the
        current war between Israel and Hamas and any deterioration of the war in Israel</font>&#160;<font style="font-style: italic;">into a broader regional conflict involving&#160;Israel&#160;with other
        parties. These factors, and other important factors discussed in the Company's Annual Report on Form 20-F filed with the&#160;Securities and Exchange Commission&#160;(&#8220;SEC&#8221;) on&#160;March 10, 2023, as amended, and our other reports filed with the&#160;SEC,&#160;could cause
        actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release.</font></div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25; font-weight: bold;">For further information, please contact:</div>
    <div style="line-height: 1.25;"><u>Investors:</u></div>
    <div style="line-height: 1.25;">Irina Koffler<br>
      Investor relations,&#160;LifeSci Advisors<br>
      ikoffler@lifesciadvisors.com</div>
    <div style="line-height: 1.25;">+1 917 734 7387</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;"><u>Sol-Gel Technologies</u></div>
    <div style="line-height: 1.25;">Gilad Mamlok<br>
      Chief Financial Officer<br>
      gilad.mamlok@sol-gel.com</div>
    <div style="line-height: 1.25;"> <br>
    </div>
    <div style="line-height: 1.25;">
      <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"> </div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
  </div>
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