Basal Cell Nevus Syndrome

An ongoing phase 3 clinical trial of SGT-610 for Gorlin Syndrome with the first patient screened; Results are expected by the end of 2025 Sol-Gel maintains a cash runway into the second half of 2025 NESS ZIONA, Israel, March 13, 2024 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company with an innovative pipeline and approaches to develop a pioneering treatment for patients with severe skin conditions, is conducting a phase 3 clinical trial of SGT-610 (Patidegib gel, 2%), an Orphan Drug candidate with the potential to be the first therapy for preventing new basal cell carcinomas in Gorlin syndrome and partnered with Galderma to commercialize two approved large-category dermatology products, TWYNEO® and EPSOLAY®, in the U.S, today announced financial results for the full year ended December 31st, 2023 and provided a corporate update. 2023 - Corporate Highlights and Recent Developments On November 30, 2023, Sol-Gel announced that it had begun Phase 3 testing of SGT-610 for Gorlin syndrome, with the first patient screened. Sol-Gel acquired Patidegib from PellePharm Inc. and is currently the only therapy in development to prevent the development of new BCC lesions in Gorlin syndrome patients. SGT-610 is a new topical hedgehog inhibitor 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. Sol-Gel is conducting a Phase-3 clinical trial to investigate SGT-610 in approximately 140 subjects at about 40 experienced clinical centers in North America, the United Kingdom, and Europe.On June 6, 2023, Sol-Gel and Searchlight Pharma Inc. announced licensing agreements to commercialize TWYNEO and EPSOLAY in Canada, according to which Sol-Gel is to receive up to $11 million in upfront payments and regulatory and sales milestones for both drugs, combined plus additional royalties ranging from low double digits to high- teen.On January 27, 2023, Sol-Gel announced the acquisition of topically applied patidegib, a hedgehog signaling pathway blocker, for the treatment of Gorlin syndrome for PellePharm Inc., for an upfront payment of $4.7 million, total development and NDA acceptance milestones of up to $6 million and based on the expected market potential up to $64 million in commercial milestones, as well as single digit royalties. Gorlin syndrome is a rare disease with no currently approved therapies by the U.S. Food and Drug Administration (FDA) or European Medical Association (EMA). Investigational compound SGT-610 has the potential to be the first-ever drug for the chronic prevention of BCCs in Gorlin syndrome patients if approved.Over the full year of 2023, TWYNEO grew its total prescriptions, with cumulative annual total prescriptions exceeding 106,000 and total prescriptions in the fourth quarter exceeding 27,000, as reported by IQVIA. The number of prescribers also grew quarterly, with a 6% growth of new prescribers for the fourth quarter. The majority of scripts were written by TWYNEO’s high base of recurring prescribers, with fourth-quarter patient refills increasing by 12%, driven by a targeted adherence campaign. In addition, TWYNEO increased its broad commercial formulary coverage, with over 6 million additional lives covered between December 2022 and December 2023 per MMIT Analytics. (*)Over the full year of 2023, EPSOLAY also grew its total prescriptions every quarter, leading to cumulative annual total prescriptions of approximately 53,000 and total prescriptions in the fourth quarter exceeding 14,000, as reported by IQVIA. EPSOLAY also experienced quarterly growth in terms of the number of prescribers, with unique prescribers growing by 8% in the fourth quarter. Resulting from a targeted patient adherence campaign also for EPSOLAY, there was a significant increase in patient refills of 34% in the quarter. Overall, EPSOLAY grew commercial formulary coverage annually by over 12 million covered or better lives, according to MMIT Analytics.(*) MMIT - Managed Markets Insight & Technology Based on Sol-Gel's financing and adoption of cost-saving measures during 2023, the company continues to maintain its cash runway into the second half of 2025. Alon Seri-Levy, Ph.D., Chief Executive Officer of Sol-Gel, stated: "Sol-Gel is advancing the pivotal Phase 3 clinical trial with SGT-610 in accordance with the planned timelines and expects to have the results by the end of 2025. We estimate that the current trial protocol and its defined targets may facilitate the essential outcome, allowing Sol-Gel to provide Gorlin syndrome patients with the first drug that could prevent new BCCs, with a potential market estimated at more than $300 million. Concurrently, we are pursuing additional out-license agreements similar to the agreements signed this year with Searchlight Pharma for Canada. Sol-Gel’s current product portfolio, led by SGT-610 and SGT-210, positions us with substantial assets for the future." Financial Results for the Year Ended December 31st, 2023 We generated $1.6 million in revenue in 2023, mainly related to the license agreements with Galderma and Searchlight, comprised of milestone and royalty payments, compared with $3.9 million in total revenues in 2022. The decrease in revenues in 2023 resulted mainly from the milestone payment from Galderma related to the FDA approval of Epsolay in 2022. Our research and development expenses were $23.5 million for the year ended December 31, 2023, compared to $12.7 million for the year ended December 31, 2022. The increase of $10.9 million was primarily attributed to the $4.7 million upfront payment associated with the acquisition of topically applied patidegib, or SGT-610, $4.2 million related to the pivotal Phase 3 clinical trial for SGT-610, and $2.8 million related to clinical expenses for a generic product. Our general and administrative expenses were $7.4 million for the year ended December 31, 2023, compared to $7.4 million for the year ended December 31, 2022. Sol-Gel reported a net loss of $27.2 million and $1.01 or $1.01 per basic share and diluted share, compared to a net loss of $14.9 million in 2022 and a loss of $0.65 per basic and diluted share. As of December 31, 2023, Sol-Gel had $17.6 million in cash, cash equivalent, and bank deposits and $20.4 million in marketable securities for a total balance of $38.0 in comparison to December 31, 2022, of $24.9 million in cash, cash equivalent, and bank deposit and $8.7 million in marketable securities for a total balance of $33.6 million. About Gorlin Syndrome and SGT-610 SGT-610, a hedgehog signaling pathway blocker, has the potential to be the first ever treatment for prevention of BCCs in Gorlin syndrome patients, if approved. Gorlin syndrome, an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the 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 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. About Sol-Gel Technologies Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing or partnering drug products to treat skin diseases. Sol-Gel developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris inadults 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 US, and Searchlight in Canada. The Company’s pipeline also includes Phase 3 clinical trial of Orphan and breakthrough drug candidate SGT-610, which is a new topical hedgehog inhibitor being developed to prevent the new basal cell carcinoma lesions in patients with Gorlin syndrome that is expected to have an improved safety profile compared to oral hedgehog inhibitors as well as topical drug candidate SGT-210 under investigation for the treatment of rare hyperkeratinization disorders. For additional information, please visit our new website: 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, including, but not limited to, the potential market of SGT-610, SGT-610 potential as the first therapy for preventing new basal cell carcinomas in Gorlin syndrome, SGT-610 improved safety profile compared to oral hedgehog inhibitors, timing of completing the Phase 3 clinical trial of SGT-610, number of subjects and clinical centers in the Phase 3 clinical trial of SGT-610, success of any clinical studies, and obtaining regulatory approval for our product candidates including SGT-610; our expected cash runway; our ability to out-license additional international rights for TWYNEO and EPSOLAY; and the commercial acceptance and profitability of TWYNEO and EPSOLAY. 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 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, including the timing of completing the Phase 3 clinical trial of SGT-610, 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’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ 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; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the current war between Israel and Hamas and any deterioration of the war in Israel into a broader regional conflict involving Israel with other parties. These factors, 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 10, 2023, as amended, 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. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release. Sol-Gel Contact:Gilad MamlokChief Financial Officer+972-8-9313433 Source: Sol-Gel Technologies Ltd. SOL-GEL TECHNOLOGIES LTD.CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands, except share and per share data) December 31 2022 2023 Assets CURRENT ASSETS: Cash and cash equivalents$12,448 $7,513Bank deposits 12,500 10,012Marketable securities 8,678 20,471Accounts receivables 62 377Receivables from collaborative arrangements 7,858 -Prepaid expenses and other current assets 1,509 2,794TOTAL CURRENT ASSETS 43,055 41,167 NON-CURRENT ASSETS: Restricted long-term deposits and cash equivalents 1,288 1,284Property and equipment, net 660 434Operating lease right-of-use assets 876 1,721Other long-term assets - 55Funds in respect of employee rights upon retirement 749 626TOTAL NON-CURRENT ASSETS 3,573 4,120TOTAL ASSETS $46,628 $45,287 Liabilities and shareholders' equity CURRENT LIABILITIES: Accounts payable$251 $154Other accounts payable 2,360 3,921Current maturities of operating leases 718 447TOTAL CURRENT LIABILITIES 3,329 4,522 LONG-TERM LIABILITIES: Operating leases liabilities 54 1,206Liability for employee rights upon retirement 1,032 915TOTAL LONG-TERM LIABILITIES 1,086 2,121 TOTAL LIABILITIES 4,415 6,643 COMMITMENTS (Note 7) SHAREHOLDERS' EQUITY: Ordinary shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2022 and 2023, respectively; issued and outstanding: 23,129,469 and 27,857,620 as of December 31, 2022 and December 31, 2023, respectively 638 774Additional paid-in capital 234,640 258,173Accumulated deficit (193,065) (220,303) TOTAL SHAREHOLDERS' EQUITY 42,213 38,644 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY$46,628 $45,287 SOL-GEL TECHNOLOGIES LTD.CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands, except share and per share Data) Year ended December 31, 2021 2022 2023 COLLABORATION REVENUES23,772 - -LICENSE REVENUES7,500 3,883 1,554TOTAL REVENUES31,272 3,883 1,554 RESEARCH AND DEVELOPMENT EXPENSES20,381 12,682 23,541GENERAL AND ADMINISTRATIVE EXPENSES8,451 7,445 7,373OTHER INCOME, net524 - 55TOTAL OPERATING INCOME (LOSS)2,964 (16,244) (29,305)FINANCIAL INCOME, net 257 1,321 2,067NET INCOME (LOSS) FOR THE YEAR 3,221 (14,923) (27,238)BASIC EARNINGS (LOSS) PER ORDINARY SHARE 0.14 (0.65) (1.01)DILUTED EARNINGS (LOSS) PER ORDINARY SHARE0.14 (0.65) (1.01)WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED EARNINGS (LOSS) PER SHARE: BASIC23,063,493 23,128,722 27,087,081DILUTED23,566,182 23,128,722 27,087,081

Scientific Advisory Board tasked with critical review of Phase 2b trial results to assess clinical usefulness prior to submission of New Drug Application ("NDA") to FDA TAMPA, Fla., Dec. 19, 2023 /PRNewswire/ -- At the forefront of the Inhibitor Therapeutics, Inc. (OTCQB:INTI) pipeline is the use of Itraconazole to treat basal cell carcinomas in Basal Cell Carcinoma Nevus Syndrome (BCCNS) aka Gorlin Syndrome. This rare hereditary cancer syndrome is characterized by patients with hundreds to thousands of basal cell carcinomas. BCCNS is an orphan disease with approximately 11,000 patients in the USA. It is an autosomal dominant disorder that may affect every organ system. Currently the first line treatment for BCCs on exposed areas such as the face and neck is Mohs Surgery which becomes increasingly challenging and leads to permanent scarring and disfiguration. As patients age as they may undergo hundreds of surgeries. Inhibitor believes that itraconazole has clinically meaningful effects on the BCCs, which led us to recruit a team of five experienced Mohs surgeons to form a Scientific Advisory Board (SAB) to critically review the outcomes of Inhibitor's phase 2b trial in BCCNS. They are academically affiliated, well-respected leaders in the practice of treating basal cell carcinomas and other skin cancers The purpose of the SAB is to assess the clinical benefits of adding itraconazole to the therapeutic options for the basal cell carcinomas in these patients. The initial focus of the SAB is a review of the final clinical outcomes of INTI's phase 2b study of itraconazole in BCCNS. Due to a recently resolved dispute with the former supply partner, the trial results are now available but have not been publicly released, nor shared with the trial investigators, or filed with the FDA for guidance. Our Phase 2b SCORING Trial completed during 2018 assessed 477 pre-existing surgically eligible target lesions across 38 patients. Unlike virtually all other disseminated cancers that have a single primary with metastatic lesions, the standard measure of response is RECIST (Response Criteria in Solid Tumors) which are size criteria based upon an analysis of response by patient. RECIST criteria were developed for primary tumors with or without metastatic lesions. Unlike other cancers, in BCCNS, every patient had multiple tumors (on average over 12) and all the tumors are primaries. In this cancer syndrome, the 477 surgically eligible tumors each represented a unique basal cell carcinoma not a metastatic lesion. The median duration of treatment was 213 days (ranging from 38 to 1117 days)., It was observed that 275 of the 477 surgically eligible lesions (57.6%) met a clinically meaningful degree of reduction of 30% or more with 130 lesions (27.3%) resolving completely and 145 tumors (29.7%) shrinking in size by at least 30% and 64 lesions (13.4%) were stabilized. A total of 13 new surgically eligible BCCs occurred in 8 patients between Week 16 and Week 109, wherein 6 patients developed a new single lesion and 2 subjects developed multiple new lesions. The median duration of response was 540 days. Upon review of the 'Change from Baseline for All Target Lesions' it was found that across the 477 lesions reductions of any size from baseline was reported in 399 lesions, 64 had no change, and 14 increased in size. The itraconazole oral treatment demonstrated a level of safety commensurate with the known profile and was generally well tolerated. Only one patient discontinued the drug because of progressive disease. There were no treatment-related serious adverse events. Patients with BCCNS are predominantly concerned with the high number of surgical interventions required during their lifetime and the disfigurement that results from these procedures, particularly on areas of the body such as the face that are exposed to the public. Therefore, a therapy without significant toxicity that can reduce the number of lesions that require a scar producing intervention will fulfill an unmet need for these patients. The review of the Phase 2b Clinical Study Report by our Scientific Advisory Board will focus on whether the SCORING trial is sufficiently clinically meaningful to warrant filing itraconazole for a New Drug Application ("NDA") as the first and only drug to be approved to treat BCCNS. The Gorlin Syndrome Alliance (a non-for-profit independent patient advocacy organization) (GSA) conducted an EL-PFDD (externally led patient focused drug development) meeting on October 8, 2021. This was conducted to help advance the GSA's mission to thoughtfully support, comprehensively educate, and aggressively seek the best treatments and a cure for those affected by Gorlin Syndrome. A majority of participants with Gorlin Syndrome at the meeting clearly felt that short of a cure, reducing the tumor burden of BCCs by at least 30% would be a meaningful clinical endpoint. Scientific Advisory Board Members Dr. Elizabeth M. Billingsley, MD., Head of the SAB, Is a Professor of Dermatology with Penn State Health Hershey Medical Center, and Penn State College of Medicine. She received her undergraduate degree from Cornell University and her medical degree from Penn State University College of Medicine. She is a Mohs micrographic surgeon with more than 30 years' experience in Mohs Surgery and skin cancer management. She also has performed numerous clinical trials related to skin cancer. Dr Billingsley is a past president of the American College of Mohs Surgery. She is affiliated with the Gorlin Syndrome Alliance and is a member of their Medical and Scientific Advisory Committee. Dr. Marc D. Brown, MD developed an interest in dermatology after an extensive education. He completed a dermatology residency at the University of Michigan in 1987. Following this came a two-year fellowship training for Mohs Surgery and Cutaneous Oncology. He joined the faculty at the University of Rochester Medical Center in 1989 and is a tenured professor of Dermatology and Oncology and is a member of the Wilmot Cancer Center. He served as the director of the Dermatology Residency Program and the Mohs Surgery Fellowship Program at the Rochester Medical Center. He has been included in the Best Doctors in America directory and has published a lengthy list of literature. Dr. Brown performs Mohs surgery on over 2,000 patients per year and has performed a total of more than 50,000 Mohs procedures. Dr. Allison Vidimos, RPh, MD. was appointed Chairman of the Department of Dermatology at Cleveland Clinic 2005 and Vice Chairman of the Dermatology and Plastic Surgery Institute in 2006. She was appointed Professor of Dermatology, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University in 2011. She became the program director of the Micrographic Surgery and Dermatologic Oncology fellowship in 2013. She was a member of the Scientific Assembly Committee and Membership Committee for the American Academy of Dermatology (AAD) 2012-17. She was elected to the Board of Directors of the AAD in 2022. She served as President of the American College of Mohs Surgery (ACMS) in 2017-2018. Dr Vidimos received the Frederic Mohs Lifetime Achievement Award in 2021. She was appointed to the Board of Directors for the American Board of Dermatology for 2019-2027 and is a member and Chairman of the board question writing committee for dermatologic surgery. She was elected to the Board of Directors of the Ohio Dermatological Association (ODA) in 2019-21 and is President of ODA 2022-23. Her clinical practice and research encompass skin cancer prevention, diagnosis and treatment, and patient safety. Dr. Sean R. Christensen, MD, PhD. is an Associate Professor of Dermatology; Director of Resident Education in Dermatologic Surgery; Director of Dermatologic Surgery at Yale Dermatology-Branford. Dr. Christensen has been practicing dermatologic surgery since completing training in 2013. His surgical specialization includes Mohs surgery, treatment of early-stage melanoma, and surgical reconstruction. Additionally, Dr. Christensen focuses on complex skin cancer issues such as field characterization, preventative strategies in high-risk patients and management of advanced or aggressive skin cancer. Dr. Christensen has published extensively on skin cancer pathogenesis and treatment and has experience in clinical trials for basal cell carcinoma. He is a frequent lecturer at national meetings for organizations such as the American Academy of Dermatology and the American College of Mohs surgery, and currently serves as the Treasurer for the International Transplant Skin Cancer Collaborative. Dr. Ian Maher, MD. is a Professor of Dermatology and Director of Dermatologic Surgery at University of Minnesota. He is board certified in Mohs surgery, specializing in the treatment of a broad range of common and rare skin cancers as well as post-skin cancer reconstruction. Dr. Maher has served on the Boards of multiple national Dermatologic organizations. He has published over 100 peer-reviewed articles. Readers are encouraged to visit the Gorlin Syndrome Alliance website () with special attention to the Externally led, Patient Focused Drug Development white paper () and the Voice of Patient Gallery. This report reflects the challenges and needs of patients with this syndrome. For more information about Inhibitor and our mission please visit us on our website () and for any further or specific queries you may have please visit our contact us page, submit your details/query, and a representative will be happy to get in touch. Forward-Looking Statements This press release contains projections and other forward-looking statements regarding future events and our future financial performance. All statements other than present and historical facts and conditions contained in this release, including any statements regarding future results of operations and financial positions, business strategy and plans, expectations for future FDA approval and product sales, our ability to convert our pipeline to revenue and our objectives for future operations, are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. We undertake no obligation to update the information made in this release in the event facts or circumstances subsequently change after the date of this press release. We operate in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, you should not rely on or place undue reliance on these forward-looking statements. Actual events or results may differ materially from those contained in the projections or forward-looking statements. SOURCE INHIBITOR Therapeutics, Inc.

A critical milestone completed on the mission path of commercializing Itraconazole in numerous oncology indications. TAMPA, Fla., Dec. 13, 2023 /PRNewswire/ -- Inhibitor Therapeutics, Inc. ("Inhibitor") (OTCQB: INTI) has entered into an exclusive, worldwide licensing agreement (the "License") with Johns Hopkins University (JHU) for their U.S Patent 8,980,930 (Canada Patent 2,572,223) "New Angiogenesis Inhibitors". Angiogenesis Inhibitors, as described by the National Cancer Institute, are unique cancer fighting agents as they block the growth of blood vessels that support tumor growth rather than blocking the growth of the tumor cells themselves. Inventors affiliated with JHU developed this patent, listing Itraconazole as an Active Pharmaceutical Ingredient (API) that has anti-angiogenic properties. The License notes field of use is for use in Prostate Cancer, Basal Cell Carcinoma including Basal Cell Carcinoma Nevus Syndrome (an orphan oncology disease), and Lung Cancer, all of which emphasize a significant unmet need. Inhibitor believes the License is a mutually beneficial agreement, yielding a modest annual royalty rate with milestone payments typical to such a license. Within the literature Head et al1 explains the long-term recognition that angiogenesis is a requirement for tumor growth and metastasis and that growing tumors can promote angiogenesis by secreting proangiogenic factors such as VEGF, basic FGF, EGF and others. These proangiogenic factors stimulate the proliferation, migration, and differentiation of the endothelial cells that make up the inner layer of all blood vessels, causing them to form new vessels that grow towards the source of these factors, this process termed "tumor angiogenesis". It is identified that the major target of itraconazole in endothelial cells is VDAC1. VDAC1 knockdown profoundly inhibits mTOR activity and cell proliferation in HUVEC revealing a previously unknown connection. Inhibition of VDAC1 by itraconazole leads to an increase in cellular AMP:ATP ratio and activation of the AMP-activated protein kinase (AMPK), an upstream regulator of mTOR. VDAC1-knockout cells are resistant to AMPK activation and mTOR inhibition by itraconazole, demonstrating that VDAC1 is the mediator of this activity. In their testing it was found that by using a phenotypical approach starting with the effect of itraconazole the G1-S cell cycle transition of the endothelial cells, itraconazole specifically inhibited the mTOR signaling pathway by downregulating the kinase activity of mTORC1. Chow Et Al2 completed a study utilizing RNA sequencing to decipher the biological pathway propelling BCC growth. From the assay results, it was observed that BCCs exhibited a considerable amplification in the expression of the mTOR pathway. This pathway plays an essential role in regulating angiogenesis, the growth of new blood vessels from pre-existing ones. Thus, this indicates that it is the heightened activity of the mTOR pathway, and the consequent enhancement of angiogenesis, that stimulates the growth. Data from Inhibitor's completed Phase 2b SCORING Trial complements the literature with reference to the Lesion Response of the study which shows that across the 477 target lesions the investigators reported reductions of any size from baseline for 399 (83.65%) lesions, 64 (13.42%) had no change and 14 increased in size. A pre-determined reduction of 30% or greater was seen in 275 of the 477 (57.7%) target lesions, including 130 lesions which resolved completely (27.3%). A total of 13 new 'surgically eligible' lesions across 8 of the 38 patients developed over the duration of the study. For more information about Inhibitor and our mission please visit us on our website () and for any further or specific queries you may have please visit our contact us page, submit your details/query, and a representative will be happy to get in touch. Forward-Looking Statements This press release contains projections and other forward-looking statements regarding future events and our future financial performance. All statements other than present and historical facts and conditions contained in this release, including any statements regarding future results of operations and financial positions, business strategy and plans, expectations for future product sales, our ability to convert our pipeline to revenue and our objectives for future operations, are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. We undertake no obligation to update the information made in this release in the event facts or circumstances subsequently change after the date of this press release. We operate in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, you should not rely on or place undue reliance on these forward-looking statements. Actual events or results may differ materially from those contained in the projections or forward-looking statements. SOURCE INHIBITOR Therapeutics, Inc.