Benzoyl Peroxide/Tretinoin

Following recent transactions and cost-cutting efforts, Sol-Gel’s cash runway is expected to extend into the first quarter of 2026Ongoing Phase 3 clinical trial of SGT-610 for Gorlin Syndrome with over 30 clinical sites activated; Top-line results are expected by the second quarter of 2026SGT-210 proof-of-concept study in patients suffering from Darier disease, a significant unmet medical need in dermatology, is ongoingSol-Gel sells its rights in the Abbreviated New Drug Application (ANDA) drug product generic to Zoryve® Cream (roflumilast cream 0.3%)Following management realignment, Mr. Mori Arkin, the Company’s executive chairman and controlling shareholder to be appointed as Company’s interim CEO as of January 1, 2025, subject to shareholders approvalSol-Gel recently signed license agreements with respect to TWYNEO and EPSOLAY in Europe and South Africa and is negotiating additional license deals in Latin America and other territories NESS ZIONA, Israel, Aug. 17, 2024 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with severe skin conditions, conducting a Phase-3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, and with two approved large-category dermatology products, TWYNEO® and EPSOLAY®, today announced financial results for the second quarter ended June 30, 2024, and provided a corporate update. Q2 2024 and Recent Corporate Developments On August 15, 2024, Sol-Gel signed a new agreement with Padagis, which replaces the parties’ prior collaborative agreement for the development and commercialization of a drug product generic to Zoryve® Cream (roflumilast cream 0.3%). Under this new agreement, Sol-Gel is to unconditionally receive quarterly payments which will be paid over 24 months and low single digit royalties from gross profits from sales of roflumilast cream for a period of five years, in lieu of its 50% share in future gross profits from such sales. In addition, Sol-Gel will cease paying any outstanding and future costs related to this prior collaborative agreement. The amount to be received by Padagis together with the elimination of future expected expenses related to this asset is expected to enhance our cash position by approximately $6 million.Recognizing that TWYNEO and EPSOLAY have a significant commercial potential also outside the U.S., during July 2024, Sol-Gel has successfully signed six initial license agreements with key partners covering most European countries and South Africa. Sol-Gel expects to sign additional agreements covering the majority of Latin American countries, Australia, New Zealand, South Korea, Spain, Italy and Portugal. These already signed agreements together with agreements we anticipate to sign in the future, are expected to provide upfront and regulatory milestone payments of up to $3.7 million, which we expect to utilize on adapting TWYNEO and EPSOLAY to the regulatory requirements of these new territories. Based on the forecasts received from Sol-Gel’s current and potential partners, Sol-Gel expects that TWYNEO and EPSOLAY will launch in the majority of these new territories in 2027 and 2026 respectively, and following launch these transactions are anticipated to provide Sol-Gel with an annual royalty revenue stream starting with approximately $1 million to $2 million in 2026 and growing gradually to approximately up to $10 million for the year 2030 and further.The Phase 3 study in Sol-Gel’s key asset SGT-610 in approximately 140 subjects (with 100 subjects required to complete the Study), at about 42 experienced clinical centers is ongoing. To date, Sol-Gel has signed agreements with 39 centers in multiple countries, including the U.S., Germany, Italy, France, and the UK, and approximately 29 of these enters have been activated. Top line results are anticipated in Q2 2026. SGT-610 is a topically applied patidegib, a hedgehog signaling pathway blocker 2% gel If approved, SGT-610 is expected to be the first approved product for the prevention of new BCC lesions in Gorlin syndrome patients and is targeting a market exceeding $300 million annually. Sol-Gel’s proof-of-concept study for SGT-210 (topical erlotinib) in patients with Darier disease is ongoing. Darier disease is a significant unmet medical need, with a market potential estimated between $200 million to $300 million. If we successfully complete this proof-of-concept study and the required pre-clinical studies, we anticipate filing for a Phase 2 IND in Q2 2025. SGT-210 is currently being used in a compassionate use treatment of a pediatric patient suffering from a rare disease, and given the preliminary highly encouraging response,we are cautiously optimistic about the potential for success in other viable keratoderma indications, recognizing that further research and clinical studies are necessary to validate any broader applications of our therapy. Subject to shareholder approval, Mr. Arkin, the Company’s Executive Chairman and controlling shareholder, who has several decades of experience in leading positions in the pharmaceutical industry and in the dermatological space in particular, will assume the role of interim CEO as of January 1, 2025. During his tenure as interim CEO, Mr. Arkin plans to transition away from the majority of his other business activities in order to dedicate himself to his new full-time position as interim CEO of the Company. Mr. Arkin will not be entitled to any compensation for assuming this position. On July 15, 2024, Sol-Gel announced management realignment whereby pending shareholder approval our CEO Dr. Alon Seri-Levy will step down as CEO and Board Member, effective December 31, 2024,and will then continue to serve the Company as a consultant to our new CEO and management team for at least one year.Effective July 12, 2024, Mr. Eyal Ben-Or, the Company's previous Director of Finance, assumed the role of Chief Financial Officer (CFO). Prior to his employment in Sol-Gel Mr. Ben-Or worked at Mobileye and KPMG Israel. Mr. Ben-Or, is a certified public accountant, holds an MBA and a BA in accounting from the College of Management in Israel. Mr. Ben-Or replacesthe Company’s previous CFO, Mr. Gilad Mamlok, who will facilitate the transition through December 31, 2024. Mr. Mori Arkin, Executive Chairman of Sol-Gel, stated: "We are encouraged by Sol-Gel’s financial results for the second quarter of 2024 and our ability to extend our cash runway into the first quarter of 2026. We will continue to explore opportunities for non-dilutive funding to potentially further extend our runway through topline results. In our pipeline, we continue to conduct the pivotal Phase 3 clinical trial of SGT-610 for preventing new basal cell carcinomas in Gorlin Syndrome patients, targeting a market exceeding $300 million, with top line results anticipated in the second quarter of 2026 along with our proof-of-concept study for SGT-210 (topical erlotinib) in Darier disease patients targeting a market of between $200 million to $300 million. These two rare disease projects reflect the huge growth potential of a company of our size. The Sol-Gel management team and I are committed to spare no effort to realize this potential". Financial Results for the Second Quarter 2024 Total revenue in the second quarter was $5.4 million, which primarily consisted of licensing revenue from Beimei, Galderma and Searchlight, compared to $0.6 million revenues for the same period in 2023. Research and development expenses were $2.4 million compared to $5.3 million for the same period in 2023. The decrease of $2.9 million was primarily attributed to a decrease of $0.7 million in manufacturing expenses related to TWYNEO, a decrease of $0.7 million in clinical development expenses related to a generic product candidate, a decrease of $0.5 million in payroll expenses due to the adoption of cost saving measures initiated during the third quarter of 2023, a decrease of $0.5 million related to R&D expenses, a decrease of $0.3 million in clinical trial expenses related to SGT-610 and a decrease of $0.2 million in clinical expenses related to SGT-210. General and administrative expenses were $1.4 million compared to $1.8 million for the same period in 2023. The decrease of $0.4 million was mainly attributed to a decrease in professional expenses. Sol-Gel reported a net income of $1.9 million for the second quarter of 2024 and earnings of $0.07 per basic and diluted share, compared to a net loss of $6.0 million and a loss of $0.22 per basic and diluted share for the same period in 2023. As of June 30, 2024, Sol-Gel had $15.6 million in cash, cash equivalents, and deposits and $14.9 million in marketable securities for a total balance of $30.5 million. The Company expects its cash resources to fund cash requirements into the first quarter of 2026. About TWYNEO and EPSOLAY TWYNEO is a topical cream containing a fixed-dose combination of tretinoin, 0.1%, and benzoyl peroxide, 3%, cream for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. TWYNEO uses silica (silicon dioxide) core shell structures to separately micro-encapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the cream. EPSOLAY is a topical cream containing benzoyl peroxide (BPO), 5%, for the treatment of bumps and blemishes (inflammatory lesions) of rosacea in adults. EPSOLAY utilizes a proprietary, patented technology to encapsulate BPO within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release BPO over time to provide a tolerable and effective treatment. 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 Darier Disease and SGT-210 SGT-210 is a topical erlotinib drug candidate that is formulated for the treatment of Darier Disease and other hyperkeratosis-related indications. Erlotinib is a tyrosine kinase receptor inhibitor that acts on the epidermal growth factor receptor, a protein present on cell surfaces that plays a key role in promoting cell growth and division. Darier Disease is a rare, genetic keratinization disorder which is classically characterized scaly crusted papules in a seborrheic distribution and in skin folds. About Sol-Gel Technologies Sol-Gel Technologies, Ltd. is a 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 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. 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 hyper keratinization 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 amounts to be received under our current and future licensing agreements and our agreement with Padagis with respect to the generic drug product to Zoryve® Cream (roflumilast cream, 0.3%), the out-licensing Twyneo and Epsolay in additional territories, our expected cash runway, the expected royalties amounts to be received from Galderma, the potential of Sol-Gel’s assets including Twyneo, Epsolay, SGT-610, and SGT-210, the timeline for advancing SGT-610 and SGT-210, and the size of SGT-610’s market. 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, our ability to enter into further collaborations, lower than anticipated annual revenue income from new collaborations, 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’ 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, China, 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 13, 2024, 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:Eyal Ben-OrChief Financial Officerinfo@sol-gel.com+972-8-9313429 Source: Sol-Gel Technologies Ltd. SOL-GEL TECHNOLOGIES LTD.CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands, except share and per share data)(Unaudited) December 31, June 30, 2023 2024 Assets CURRENT ASSETS: Cash and cash equivalents$7,513 $11,549Bank deposits 10,012 4,012Marketable securities 20,471 14,912Accounts receivables 377 6,059Prepaid expenses and other current assets 2,794 1,750TOTAL CURRENT ASSETS 41,167 38,282 NON-CURRENT ASSETS: Restricted long-term deposits and cash equivalents 1,284 1,273Property and equipment, net 434 305Operating lease right-of-use assets 1,721 1,507Other long-term assets 55 34Funds in respect of employee rights upon retirement 626 604TOTAL NON-CURRENT ASSETS 4,120 3,723TOTAL ASSETS$45,287 $42,005Liabilities and shareholders' equity CURRENT LIABILITIES: Accounts payable$154 $679Other accounts payable 3,921 4,147Current maturities of operating leases 447 376TOTAL CURRENT LIABILITIES 4,522 5,202 LONG-TERM LIABILITIES Operating leases liabilities 1,206 1,018Liability for employee rights upon retirement 915 883TOTAL LONG-TERM LIABILITIES 2,121 1,901TOTAL LIABILITIES 6,643 7,103 SHAREHOLDERS' EQUITY: Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2023 and June 30, 2024; issued and outstanding: 27,857,620 as of December 31, 2023 and June 30, 2024. 774 774Additional paid-in capital 258,173 258,799Accumulated deficit (220,303) (224,671)TOTAL SHAREHOLDERS' EQUITY 38,644 34,902TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY$45,287 $42,005 SOL-GEL TECHNOLOGIES LTD.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands, except share and per share data)(Unaudited) Six months endedThree months ended June 30 June 30 2023 2024 2023 2024REVENUE$894 $5,899 $594 $5,433RESEARCH AND DEVELOPMENT EXPENSES 14,698 7,783 5,312 2,438GENERAL AND ADMINISTRATIVE EXPENSES 3,786 3,203 1,809 1,371OPERATING INCOME (LOSS)$(17,590) $(5,087) $(6,527) $1,624FINANCIAL INCOME, net 899 719 557 352NET INCOME (LOSS) FOR THE PERIOD$(16,691) $(4,368) $(5,970) $1,976BASIC AND DILUTED EARNINGS (LOSS) PER ORDINARY SHARE$(0.63) $(0.16) $(0.22) $0.07WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 26,306,484 27,857,620 27,660,326 27,857,620

Phase 3 interim analysis outcome still expected in Q3 2024 for the overall response rate (ORR) in the pivotal trial (IOB-013/KN-D18) of lead investigational therapeutic cancer vaccine, IO102-IO103, in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced melanoma; outcome of primary endpoint of progression free survival (PFS) expected in first half of 2025Completed enrollment in Phase 2 basket trial IOB-022/KN-D38 evaluating IO102-IO103 in combination with pembrolizumab in patients with non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN); data from SCCHN cohort has been accepted for poster presentation at the European Society for Medical Oncology (ESMO 2024) congress; abstract with data from NSCLC cohort has been submitted for poster presentation at an upcoming fall medical meeting Completed enrollment in first cohort (cohort A) of Phase 2 solid tumor basket trial (IOB-032/PN-E40) evaluating IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment of patients with resectable solid tumors; initiated enrollment in randomized melanoma cohort Ended second quarter with approximately $100.7 million in cash and cash equivalents; the company confirms that cash position is expected to support operations into the fourth quarter of 2025 NEW YORK, Aug. 13, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today reported financial results for the second quarter ended June 30, 2024. “During the first half of this year, we’ve continued to execute on our mission of developing breakthrough cancer vaccines that could potentially change the treatment paradigm for people living with melanoma and other types of cancer,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “We look forward to the planned interim analysis of our pivotal Phase 3 trial in first-line advanced melanoma followed by the data readout of the primary endpoint of progression free survival (PFS) in the first half of next year. Strategically, we continue to prepare for a potential launch in 2025 if the interim analysis data supports accelerated approval in the US.” Dr. Zocca continued, “We are also focused on progressing our Phase 2 studies of IO102-IO103 in other hard-to-treat cancers and earlier line of treatment in melanoma patient populations, and are excited to share new insights this fall on the potential of IO102-IO103 in the first-line treatment of SCCHN and metastatic NSCLC.” Recent Business Highlights The independent data monitoring committee (IDMC) for the company’s pivotal Phase 3 trial (IOB-013/KN-D18), which is evaluating IO102-IO103 in combination with KEYTRUDA® (pembrolizumab) in advanced melanoma, is expected to independently conduct a review of interim analysis data in the third quarter of 2024. The primary endpoint of the Phase 3 trial is PFS, which will be analyzed when 226 events have occurred in the trial, and the outcome of which the company projects will occur in the first half of 2025. If the IDMC recommendation after review of the interim analysis data is supportive, we believe the outcome could allow for submission of a Biologics License Application (BLA) in fourth quarter of 2024 for accelerated approval in the US.Updated data for the head and neck cohort of the company’s Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic NSCLC or recurrent or metastatic SCCHN was accepted for poster presentation at the European Society of Medical Oncology (ESMO 2024) congress taking place September 13-17 in Barcelona. This presentation will share efficacy and safety data for the full patient cohort, which completed enrollment earlier this year. The company plans to share updates from the NSCLC cohort, which also completed enrollment, at a medical meeting this fall.The company continued to progress its Phase 2 solid tumor basket trial (IOB-032/PN-E40) studying treatment with IO102-IO103 in combination with pembrolizumab given before (neoadjuvant) and after (adjuvant) surgery with curative intent in patients with resectable melanoma or SCCHN. The single arm melanoma cohort of the trial, cohort A, is now fully enrolled and enrollment in the single arm SCCHN cohort, cohort B, continues. Enrollment is also ongoing in the randomized melanoma cohort, cohort C, in which patients are randomized either to IO102-IO103 in combination with pembrolizumab or to pembrolizumab alone. Second Quarter 2024 Financial Results Net loss for the three months ended June 30, 2024, was $20.7 million, compared to $21.2 million for the three months ended June 30, 2023.Research and development expenses were $15.8 million for the three months ended June 30, 2024, compared to $16.5 million for the three months ended June 30, 2023. The decrease was primarily related to timing of clinical trial-related activities for the company’s IO102-IO103 therapeutic cancer vaccine candidate, including the continued execution of the company’s pivotal Phase 3 clinical trial. The company recognized $0.7 million in research and development equity-based compensation for the three months ended June 30, 2024, compared to $0.9 million for the three months ended June 30, 2023.General and administrative expenses were $5.7 million for the three months ended June 30, 2024, compared to $5.3 million for the three months ended June 30, 2023. The company recognized $1.0 million in general and administrative equity-based compensation for the three months ended June 30, 2024, compared to $0.7 million for the three months ended June 30, 2023.Cash and cash equivalents as of June 30, 2024 were $100.7 million, compared to $143.2 million at December 31, 2023. During the three months ended June 30, 2024, the company used cash, cash equivalents and restricted cash of $17.0 million. The company continues to expect that it will have sufficient cash to run the company into the fourth quarter of 2025. About IO102-IO103 IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) positive and programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neoadjuvant/adjuvant treatment of patients with solid tumors. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. A total of 407 patients have been enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study is progression free survival, an event-driven analysis conducted when 226 events, defined as disease progression or death, have been reported in the study. Secondary endpoints include overall response rate (ORR), overall survival (OS), durable objective response (DRR), complete response rate (CRR), duration of response (DoR), time to complete response (TTCR), disease control rate (DCR), and incidence of AEs and SAEs (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. About the IOB-013/KN-D18 Clinical Trial Endpoints The primary endpoint of the IOB-013/KN-D18 trial is progression free survival (PFS). The PFS analysis is event-driven and will be conducted when 226 events have occurred in the trial, which the company estimates will take place in the first half of 2025. Additionally, there is a planned per-protocol interim analysis of overall response rate when the first 225 randomized patients reach one year of treatment in mid-2024. The outcome of this analysis is expected in the third quarter of 2024. There is a high statistical bar for the Phase 3 interim analysis (p≤0.005), which was set to preserve most of the alpha for the primary endpoint of PFS. Regardless of the outcome of the interim analysis, the trial is designed to continue to the primary PFS endpoint. About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in first-line advanced cancers in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial IOB-032/PN-E40 (NCT05280314) is a Phase 2 basket trial investigating the IO102-IO103 therapeutic cancer vaccine in combination with pembrolizumab as neoadjuvant/adjuvant treatment of patients with solid tumors. The study will enroll approximately 15 patients with melanoma and 15 patients with SCCHN in cohort A and cohort B respectively as single arm cohorts receiving combination of IO102-IO103 with pembrolizumab, whereas in cohort C ≥60 melanoma patients will be randomized 1:1 to either the combination of IO102-IO103 with pembrolizumab or pembrolizumab alone. In the neoadjuvant period, for all cohorts, treatment is every 3 weeks (Q3W) for 3 cycles (melanoma) or 2-3 cycles (SCCHN). Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 4-9 weeks prior. Surgery will be followed by adjuvant treatment with the same regimen for 15 cycles. Cohort C patients with poor pathological response to pembrolizumab alone in the neoadjuvant phase (>10% residual viable tumor) may cross over to combination treatment post-surgery. The primary endpoint is major pathological response at surgery (≤10% residual viable tumor; central assessment). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab. About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York. For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech). Forward-Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing of the interim and primary analyses of the company’s Phase 3 trial, current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. Contact:InvestorsMaryann Cimino, Director of Investor Relations IO Biotech, Inc.617-710-7305mci@iobiotech.com MediaJulie Funesti, National Health MediaEdelman917-498-1967Julie.Funesti@salutemcomms.com IO BIOTECH, INC. Consolidated Statements of Operations and Comprehensive Loss(Unaudited in thousands, except share and per share amounts) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Operating expenses Research and development$15,848 $16,504 $30,159 $28,404 General and administrative 5,685 5,348 11,571 11,372 Total operating expenses 21,533 21,852 41,730 39,776 Loss from operations (21,533) (21,852) (41,730) (39,776)Other income (expense) Currency exchange (loss) gain, net (90) 10 (552) 268 Interest income 1,311 1,196 2,928 2,224 Total other income (expense), net 1,221 1,206 2,376 2,492 Loss before income tax expense (20,312) (20,646) (39,354) (37,284)Income tax expense 374 532 789 938 Net loss (20,686) (21,178) (40,143) (38,222)Net loss attributable to common shareholders (20,686) (21,178) (40,143) (38,222)Net loss per common share, basic and diluted$(0.31) $(0.74) $(0.61) $(1.33)Weighted-average number of shares used in computing net loss per common share, basic and diluted 65,880,914 28,815,267 65,880,914 28,815,267 Other comprehensive loss Net loss$(20,686) $(21,178) $(40,143) $(38,222)Foreign currency translation (151) (141) 43 376 Total comprehensive loss$(20,837) $(21,319) $(40,100) $(37,846) IO BIOTECH, INC. Consolidated Balance Sheets(Unaudited in thousands, except share and per share amounts) June 30,2024 December 31,2023 Assets Current assets Cash and cash equivalents$100,747 $143,193 Prepaid expenses and other current assets 6,905 4,062 Total current assets 107,652 147,255 Restricted cash 268 268 Property and equipment, net 735 847 Right of use lease asset 1,936 2,259 Other non-current assets 876 89 Total non-current assets 3,815 3,463 Total assets$111,467 $150,718 Liabilities and stockholders’ equity Current liabilities Accounts payable$5,016 $3,878 Lease liability - current 678 655 Accrued expenses and other current liabilities 8,029 11,184 Total current liabilities 13,723 15,717 Lease liability - non-current 1,472 1,839 Total non-current liabilities 1,472 1,839 Total liabilities 15,195 17,556 Commitments and contingencies Stockholders’ equity Preferred stock, par value of $0.001 per share; 5,000,000 shares authorized, no shares issued and outstanding as of June 30, 2024 and December 31, 2023 — — Common stock, par value of $0.001 per share; 300,000,000 shares authorized at June 30, 2024 and December 31, 2023; 65,880,914 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 66 66 Additional paid-in capital 409,797 406,587 Accumulated deficit (303,965) (263,822)Accumulated other comprehensive loss (9,626) (9,669)Total stockholders’ equity 96,272 133,162 Total liabilities and stockholders’ equity$111,467 $150,718