Candidiasis, Vulvovaginal

Hyloris Reports Full Year Results for 2023 & Provides Business Outlook Total revenue and other income amounted to €4.4 millionStronger growth expected in 2024 of both sales and gross margin, mainly fueled by the recent launch in the U.S. of Maxigesic® IV and Podofilox gel, the global roll out of Maxigesic IV® and commercial dealsIncreased operating R&D expenses while net operating cash outflow remained stable versus 2022Significant R&D progress including clinical and regulatory achievements with multiple NDA submissions expected within the next 15 monthsAttractive commercial deals, including an out-licensing deal for Atomoxetine Oral Liquid in CanadaPromising new product candidates driving innovation, targeting a portfolio of 30 assets by 2025€30.2 million in cash & cash equivalents, no financial debtWebcast on 14 March 2024 at 1PM GMT / 2PM CET/ 9AM EST (Register here) Liège, Belgium – 14 March 2023 – 7AM CET – Regulated Information – Inside Information - Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces its financial and operational results for the year ending on 31 December 2023, as well as its business outlook for 2024. Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: “Despite a challenging year for the global healthcare industry, 2023 proved to be a year of significant accomplishment for Hyloris. As a company built on the unique and successful strategy of repurposing and reformulating existing pharmaceuticals, we achieved a major milestone with the U.S. approval of Maxigesic® IV in partnership with AFT Pharmaceuticals, marking a crucial step in delivering this innovative pain management solution to American patients. Additionally, approval was secured for Podofilox gel, the first generic version of Condylox® Gel, expanding access to this medication. Our unwavering commitment to research and development yielded impressive progress across our diverse product pipeline. These advancements solidify our position as a leader in providing solutions to unmet medical needs in the years to come. We are incredibly proud of our team's dedication and resilience throughout this transformative year. Looking ahead to 2024, Hyloris is poised for continued growth and innovation. We plan to significantly bolster our pipeline with the addition of several new product candidates addressing critical unmet medical needs. Recent additions, including treatments for Vulvar Lichen Sclerosus and Burning Mouth Syndrome, demonstrate our commitment to expanding our portfolio and addressing a wider range of patient needs. We remain confident in our ability to continue delivering value to patients, shareholders, and all stakeholders and expect continued growth beyond 2024. Commercial Highlights Maxigesic® IV is a patented, unique combination, intravenous formulation for the treatment of post-operative pain and is currently licensed to partners covering over 100 countries across the globe. During 2023 and early 2024: A marketing authorization was granted by the United States Food and Drug Administration (FDA) in October 2023.Hikma Pharmaceuticals (Hikma), a leading supplier of complex injectable hospital products, has launched the product in the U.S. under the tradename Combogesic® IV. An exclusive license and distribution agreement had previously been signed between Hyloris’ partner AFT Pharmaceuticals (AFT) and Hikma.Additional submissions for marketing authorization were made in 13 countries in the Middle East, Africa, Latin America, and Asia.Additional marketing authorizations have been granted in 8 countries including Poland, South Africa, and Spain. In early 2024, Health Canada granted approval bringing the total number of approvals to 50.Launches occurred in 14 countries including Norway, Singapore, Belgium, The Netherlands, the Czech Republic, and Romania. Imminent launches are expected in several additional countries, bringing the total number of countries where Maxigesic® IV will be available up to more than 30. In the United States, chronic opioid usage in patients following surgery averages around 9%, ranging from 4% to 24% among various specialties. Drug overdoses involving opioids resulted in over 80.000 deaths in the U.S. in 2021. Patients who experienced an opioid overdose accounted for nearly $2 billion in annual hospital costs. Sotalol IV is a patented, intravenous formulation of Sotalol for the treatment of atrial fibrillation, and life-threatening ventricular arrhythmias developed for the U.S. Sotalol IV potentially allows to significantly reduce the length of hospital stay and the overall cost of care and potentially improve patient outcomes. Hyloris is taking further steps targeting to increase product related revenues in the future (see also: Ongoing Legal Proceedings). Podofilox Gel (Product previously referenced as HY-016) In December 2023, our partner Padagis US LLC (Padagis) received marketing authorization for Podofilox gel 0.5% from the FDA. Padagis launched the product in December 2023. It is the first generic for Condylox® Gel in the U.S. Podofilox Gel is an antimycotic drug for the topical treatment of external genital and perianal warts caused by certain types of the Human Papilloma Virus (HPV). Around 1% of the sexually active population in the U.S. presents with genital or perianal warts.1 To date there is a vaccine for HPV but no cure. For the 12 months period ending December 2022, Condylox® Gel had U.S. sales of approximately $9 million according to IQVIA Health. Other Commercial Highlights Tranexamic Acid RTU Additional out-licensing agreements were signed for Tranexamic Acid RTU in 2023. These agreements cover a large European country and several major Asian countries, with a combined population of over 60 million people. Previous agreements have been signed in 2021 for Australia, New-Zealand and Canada. In 2023, our licensing partner for Canada submitted an application for approval by Health Canada. Additional regulatory submissions in the partnered territories are in progress, and more out-licensing agreements are expected going forward. An Abbreviated New Drug Application (ANDA) has been submitted to the U.S. FDA. Tranexamic acid injection is an established antifibrinolytic agent used in emergency situations with major hemorrhages and is also used as a prophylactic agent in surgeries. Hyloris is developing a ready-to-use (RTU) formulation for infusion. Atomoxetine Oral Liquid An out-licensing agreement was signed with Kye Pharmaceuticals (Kye) in October 2023. Kye will exclusively commercialize the product in Canada where atomoxetine is currently not available as an oral liquid formulation. The introduction of an oral liquid formulation in the ADHD (Attention Deficit Hyperactivity Disorder) medication category has historically led to significant market share gains2. This suggests a strong potential for Atomoxetine Oral Liquid in Canada, where an estimated 1.8 million people (or 4-6% of adults and 5-7% of children) are diagnosed with ADHD3. ADHD is a chronic condition, with symptoms persisting into adulthood for 60-80% of patients4. Under the terms of the agreement, Hyloris will be eligible to receive attractive sales-related milestone payments (totaling up to USD 7.5 million), and a substantial share of the generated revenue. New Pipeline Product Candidates Our business development team leverages its expertise in existing products, real-world data, and a vast network to identify unmet medical needs. This includes collaborating with healthcare professionals, patient groups, insurers (payors), and industry partners. In 2023 over 87 opportunities were screened and 3 product candidates will meet our investment criteria of €7 million5 in 7 years or less. For product candidates which Hyloris intends to out-license, the strategic goal is to capture a substantial part of the net product margin realized by our commercial partners. Hyloris aims to achieve this by partnering these assets close to regulatory submission, except in countries where additional local clinical trials are required. In general, we will prioritize in-market product sales or profit-based participation over (upfront) milestone payments. We aim to increase our product portfolio to 30 assets by 2025, with a focus on accelerating pipeline growth in the near future. HY-091, a novel topical treatment candidate for Vulvar Lichen Sclerosus (VLS) was announced in January 2024. VLS is a chronic inflammatory condition affecting an estimated 3% of women, causing severe pain, itching, and discomfort, significantly impacting their quality of life. HY-091 is being developed as a convenient and user-friendly treatment specifically designed to target these VLS symptoms. Hyloris has partnered with AFT for co-development, registration, and worldwide commercialization. HY-090, a promising new treatment candidate for Burning Mouth Syndrome (BMS) was announced in December 2023. BMS is a chronic condition affecting millions, primarily postmenopausal women, causing a burning, tingling, or scalding sensation in the mouth for months at a time. While the mouth appears healthy, sufferers may also experience dry mouth or taste alterations, the exact cause of BMS remains unknown. Studies suggest that 0.7% to 5% of individuals in the U.S. might be affected6. Hyloris has partnered with AFT to co-develop and commercialize the product worldwide. HY-088 was announced in January 2023. This novel, proprietary oral formulation will be administered to patients with hypophosphatemia – a condition where the blood level of phosphorus is lower than 2.5mg/dL. Patients can develop hypophosphatemia from either a genetic abnormality (such as Cushing Syndrome or osteomalacia) or an acquired condition (like long-term use of diuretics or phosphate binders). It is estimated hypophosphatemia affects around 5% of hospitalized patients, and a subpopulation needs direct treatment during and/or after their hospital stay. Treatment protocols for patients deficient in phosphate are well-established and have proven useful in other situations of bone mineral imbalance. Oral administration is the preferred way of treating hypophosphatemia, although in most countries no approved drugs exist. Currently, physicians mostly rely on compounded drugs which have, by definition, not been submitted for regulatory scrutiny regarding safety, efficacy, and quality. R&D Update Throughout 2023, Hyloris achieved significant advancements across the entire R&D portfolio, propelling the 18 product candidates and 3 high-barrier generics closer to commercialization. Key milestones were met for multiple programs, and discussions with regulatory agencies and partners are underway to solidify development plans. As a result, Hyloris anticipates submitting multiple INDs (Investigational New Drug applications) and NDAs (New Drug Applications) throughout 2024 and early 2025. Enhanced Capabilities Drive Efficiency Further bolstering our R&D efforts, Hyloris officially opened its new and improved R&D lab at the Montlegia Science Park in June 2023. This on-site facility allows Hyloris to perform drug formulation and analytical activities in-house, streamlining processes and optimizing resource allocation for the expanding pipeline. Cardiovascular Portfolio Hyloris is actively engaged in advancing a comprehensive portfolio dedicated to addressing a wide range of conditions within the largest global treatment category – cardiovascular care. These products are currently progressing through or towards clinical trials, with the aim of significantly enhancing the quality of life for patients. Main highlights for 2023 and selected expected milestones for 2024 include: Aspirin IV: Registration batches have been manufactured and the stability study is ongoing. An NDA submission is planned for the U.S. as soon as all necessary data has been collected. Aspirin IV is an intravenous (IV) formulation of acetylsalicylic acid (ASA) to be used in an emergency setting. Aspirin is not available in the U.S. as an IV product. Currently, most patients suspected of having an emergency cardiovascular event (such as a myocardial infarction or stroke) are immediately given oral aspirin to decrease their risk of morbidity and mortality. Milrinone: The optimization of the extended-release formulation for alcohol resistance marked a significant development milestone. Preparations for a pilot pharmacokinetic (PK) study are in progress. Oral milrinone is being developed as a novel, extended-release formulation offering convenient oral dosing for a selected population of end-stage heart failure (HF) patients who have Left Ventricular Assist Devices (LVADs). HY-074: All non-clinical studies were completed in 2023. A patent application was filed through the Patent Cooperation Treaty (PCT) which allows an applicant to seek patent protection in several different countries – including the U.S. Hyloris is targeting an IND submission for Q2 2024 for the PK bridging study expected to start at the end of 2024. HY-074 is an intravenous formulation of current standard of care treatment for acute coronary syndrome (ACS) to offer faster onset of action, more convenient administration, and dosage control. It is currently available in oral form, which should allow for an optimal switching strategy from the oral form to an IV in a hospital setting. Dofetilide IV: Registration batches have been manufactured and the stability study is ongoing. A CRO has been selected for the required clinical study. An NDA submission is planned for the U.S. as soon as all necessary data has been collected. A pivotal clinical study to support regulatory submission for Dofetilide IV is nearing completion, with results expected by Q3 2024. Additional U.S. patent applications have been filed to bolster the drug's intellectual property protection. Other Value-Added Programs Hyloris, in collaboration with its development partners, is achieving consistent progress on all stages of our value-added programs. Main highlights for 2023 and expected milestones for 2024 include: Tranexamic Acid Oral Mouth Rinse (previously HY-004): A Type A meeting with the FDA resulted in alignment on the phase 3 study protocol. The phase 3 trial began in November 2023, enrolling the first patient in early 2024. Completion of enrollment (Last Patient Last Visit - LPLV) is expected by year-end, with study results anticipated in the first half of 2025. This rinse targets patients on blood thinners (anticoagulant therapies) undergoing dental procedures with a high risk of excessive bleeding. Additionally, Hyloris intends to explore the effectiveness in a wider range of related oral surgery procedures, encompassing both patients with and without bleeding disorders who could benefit from a localized treatment to reduce blood clotting. Miconazole/Domiphen Bromide: Hyloris is co-developing Miconazole/Domiphen Bromide (MCZ/DB) with Purna Female Healthcare, a topical cream combining miconazole and domiphen bromide. This innovative treatment targets Recurrent Vulvovaginal Candidiasis (rVVC), a chronic and often debilitating vaginal yeast infection affecting nearly 1 in 10 women throughout their lives. The Phase 2 clinical trial, completed in late 2023 (Q4), showed promising results. The low-dose group exhibited evidence of delayed disease recurrence at day 29. These findings will be used to design the next clinical trial, scheduled to begin by year-end 2024. MCZ/DB presents a strong scientific and commercial potential for addressing rVVC. AlenuraTM: Hyloris is co-developing Alenura™ with Vaneltix. It is a first-in-class drug candidate designed to bring immediate pain relief to patients suffering from interstitial cystitis/bladder pain syndrome (IC/BPS). This chronic condition affects at least 6 million people in the U.S. alone. Alenura™ stands out for its innovative dual mode-of-action. It combines a new, alkalinized form of lidocaine for fast pain relief with heparin to potentially aid in the regeneration of the bladder lining. This unique approach holds promise for providing both immediate symptom relief and long-term benefits for IC/BPS patients. June 2023 marked a significant milestone with the enrollment of the first patient in the Phase 2 clinical trial of Alenura™. This pivotal study will compare the effectiveness of Alenura™ against its individual components (lidocaine and heparin) as well as a placebo. PTX-252: PTX-252 is a novel chelating agent in development for the treatment of Acute Myeloid Leukemia (AML). This product candidate incorporates a novel molecular entity that is a derivative of a known established molecule. This advancement was followed by positive news: Hyloris' co-development partner, Pleco, secured Orphan Drug Designation from the FDA for PTX-252 specifically for AML. PTX-252's potential lies in its ability to potentially improve the effectiveness of existing chemotherapy for AML patients. This is particularly significant as AML affects approximately 160,000 people globally. Previous research suggests a correlation between high levels of toxic metals and lower survival rates in AML patients. A Pre-Investigational New Drug (PIND) meeting with the FDA is planned. Valacyclovir: A successful study demonstrating bioequivalence was completed in 2023. An additional pivotal study can be expected to start and close in H1 of 2024. Registration batches have been manufactured to demonstrate pharmaceutical quality of the product and robustness of the manufacturing process. Hyloris is developing a liquid formulation of valacyclovir which is currently only available in oral solid form. Valayclovir is an antiviral drug commonly used to treat the Herpes Simplex Viruses (HSV) that cause cold sores, genital herpes, chicken pox, and shingles. Management & Board changes The total headcount of the Company grew to 42 people, with several key recruitments occurring over the summer. To enhance the development activities, only limited additional hiring is required. Both the C-level executives and all board members remained in their respective positions, providing continuity in the company's leadership. Business Outlook With 18 reformulated and repurposed molecules, and 3 high-barrier generics, several clinical trials are expected to start and/or finish within 2024. The Company is actively accelerating the growth of its product pipeline, aiming to reach 30 product candidates by 2025. The company is expecting several clinical and regulatory achievements in the next 15 months. Several clinical studies will be initiated or completed. The Company is anticipating multiple NDA submissions to the U.S. FDA and other regulatory agencies. Webcast Details The Company will host a webcast conducted in English to present its 2023 annual results and 2024 Business Outlook, followed by a live Q&A session. The webcast will start on March 14th 2024 at 2PM CET / 1PM GMT / 9AM EST. To join the webcast, please register at the following link: Hyloris: 2023 Full Year Results, Outlook for 2024, and Q&A For those unable to join via webcast, please find dial in information below: Phone Conference ID: 598 167 742# Belgium: +32 4 290 22 87France: +33 1 73 24 00 56Netherlands: +31 20 708 1382Switzerland: +41 43 434 66 31United Kingdom: +44 20 7660 8327United States: +1 347 378 4531Japan: +81 3 4540 5088 Financial Highlights 2023 Year ended 31 December (in € thousand)20232022 Restated*VarianceTotal Revenues and Other income4,4062,38685%Revenues2,8141,951*44%Other operating income1,5924357266%Operating expenses(20,642)(14,024)47%Cost of sales(93)(94)(1%)Research and development expenses(14,749)(10,272)44%General and administration expenses(5,653)(3,517)61%Share of result of equity-accounted investees, net of tax(147)(130)13%Other operating expenses-(12) Operating result (EBIT)(16,236)(11,638)*40%Net financial result474(127)-473%Income Taxes-(4) Profit/(Loss) for the period(15,762)(11,770)*34%Net operating cash flow(12,726)(12,499)82%Other investment-10,000 Cash and cash equivalents30,19633,457-10%Total cash and Other investment30,19643,457 *See Note: Restatement of the year 2022 and Press Release dated 14th of March 2024 related to restatement for additional information on HY-038 and HY-088. Total Revenue and Other Income In 2023, total revenue and other income increased to €4,406 thousand compared to €2,386 thousand in 2022, which is 85% higher compared to last year. The strong growth is mainly driven by increase of royalties of the 3 early-stage commercialized products, services provided to external partners and non-dilutive funding which we received from a US State Government and the Walloon region in Belgium. Results The Company realized a net loss of €15,762 thousand in 2023, compared to a net loss of €11,770 thousand last year. The net loss is mainly resulting from the increase in R&D expenditure and G&A expenses for supporting the development of the Company. R&D expenditure during 2023 amounted to €14,749 thousand, compared to €10,272 thousand in 2022. The increase was mainly driven by the progressive shift from early to late-stage development of several product candidates as well as the increased headcount of the research and development team leading to additional costs. General and administrative expenses increased to €5,653 thousand in 2023 versus €3,517 thousand in 2022, mainly driven by higher legal costs related to the AltaThera’s litigation compared to last year. The net financial income in 2023 was €474 thousand compared to a net financial loss of €127 thousand in 2022. The positive evolution of the financial result is mainly due to the impact of an active cash management strategy in a context of high short term interest rates both in EURO and USD. As a result, net losses in 2023 increased to €15,762 thousand versus €11,770 thousand in the same period of 2022. Balance Sheet The Company’s non-current assets mainly consist of (1) investments in joint ventures of € 3,801 thousand, (2) intangible assets of €3,828 thousand including capitalized development, purchased assets and in-licensing costs, versus €3,600 thousand in 2022, (3) Right of use assets related to the leasing of the office, lab and cars, (4) shares in Pleco of €1,000 thousand, (5) a prepayment of future royalties to a third party of $700 thousand and (6) a tax credit. Hyloris does not capitalize research and development expenses until the filing for a marketing authorization for the applicable product candidate. Research and development expenditures incurred during the period were accounted for as operating expenses. When an intangible asset is acquired and capitalized, the amortization begins when the asset is available for commercialization. The Company’s current assets mainly consist of €30,196 thousand in cash and cash equivalents on total assets of €47.61 million, and trade and other receivables of €4.1 million. The increase in Right-of-use assets and borrowings is due to the start of the lease for the new lab. The Company received an advance payment related to a government grant from the Walloon region. €43 thousand of this advance is a financial liability and €37 thousand is part of Trade and other liabilities. Cash Position and cash flow The Company maintains its strong cash position, with a current cash and cash equivalents totaled €30,196 thousand at the end of 2023, compared to €43,457 thousand at the end of 2022 (which includes a deposit for an amount of €10 million which has been reclassified to Other investment in 2022). Net cash outflow generated from operating activities was €12,726 thousand in 2023, compared to a net operating cash outflow of €12,499 thousand in 2022. The stable net operating cash outflow is attributed to an internal control system implemented to oversee expenditure and cash flow, which includes effective management of working capital. CONSOLIDATED STATEMENT OF FINANCIAL POSITION FOR THE YEAR ENDED DECEMBER 31 ASSETS (in thousands of euros) 31-Dec-23 31-Dec-22 Restated* Non-current assets12,33611,063 Intangible assets3,8283,607 Property, plant and equipment429176 Right-of-use assets1,724885 Equity accounted investments3,8013,948 Other investment, including derivatives1,0001,000 Trade and other receivables1.5541.447 Current assets35,27649,801 Trade and other receivables4,1004,127 Other investment, including derivatives49910,4699 Prepayments4811,748 Cash and cash equivalents30,19633,4579 TOTAL ASSETS47,61260,864 EQUITY AND LIABILITIES(in thousands of euros) 31-Dec-23 31-Dec-22 Restated* Equity 38.82254.045 Share capital140140 Share premium121,513121,513 Retained earnings, excluding profit (loss) for the reporting period(65,246)(53,476) Result of the period, profit (loss) for the reporting period(15,762)(11,770) Share based payment2.1611,621 Cost of Capital(4,460)(4,460) Other reserves476476 Non-current liabilities1.8531,047 Borrowings1,510747 Other financial liabilities344300 Current liabilities6,9375,772 Borrowings241138 Other financial liabilities3,2003,212 Trade and other liabilities3,4962,422 Current tax liabilities-- TOTAL EQUITY AND LIABILITIES47,61260,864 CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME FOR THE YEAR ENDED DECEMBER 31 in € thousands20232022 restated*VarianceRevenue 2,8141,95147%Other operating income1,5924353252%Operating income4,4062,38685%Cost of sales(93)(94)(1%)Research and development expenses(14,749)(10,272)1044%Selling, general and administrative expenses(5,653)(3,517)61%Share of result of equity-accounted investees, net of tax(147)(130)13%Other operating expenses-(12) Operating expenses(20,642)(14,024)47%Operating profit/(loss) (EBIT)(16,236)(11,638)40%Financial income86746686%Financial expenses(393)(594)-34%Profit/(loss) before taxes(15,762)(11,766)34%Income taxes-(4) PROFIT/(LOSS) FOR THE PERIOD(15,762)(11,770)34% CONSOLIDATED STATEMENT OF CHANGES IN EQUITY FOR THE YEAR ENDED DECEMBER 31 2023 (in thousands of euros) Attributable to equity holders of the CompanyTotal EquityShare capital Share premium Other reservesRetained earnings Share-based payment reserveCost of CapitalOther reservesBalance at December 31, 2021129103,6932,391(3,827)476(54,805)48,056Private Placement Via an Accelerated Bookbuild Offering514,995 (634) 14,366Equity Transaction via Transaction Warrants 62,826(1,329) 1,3292,832Share-based payments 560 560Total comprehensive income (11,770)(11,770)Balance at December 31, 2022140121,5131,622(4,460)476(65,246)54,045Share-based payments 539 539Total comprehensive income (15,762)(15,762)Balance at December 31, 2023140121,5132,161(4,460)476(81,008)38,822 CONSOLIDATED STATEMENT OF CASH FLOWS FOR THE YEAR ENDED DECEMBER 31 2023 in € thousands20232022 Restated* CASH FLOW FROM OPERATING ACTIVITIES Net result(15,762)(11,770) Adjustments to reconcile net loss to net cash provided by operating activities: Depreciation, amortisation and impairments349196 Share-based payment expense539560 Derivatives financial instruments(52)52 Interest income on deposits and current accounts-164 Net finance result(474)- Change in fair value of financial assets311- Loss on derecognition of shareholders loans-486 Equity transaction costs-29 Share of profit of equity-accounted investees, net of tax147130 Losses on disposal of PPE-16 Other non-cash adjustments(17)16 Changes in working capital: Trade and other receivables(293)(921) Other investment, including derivatives(31)4 Prepayments1,268(650) Trade and Other liabilities1,236(468) Cash generated from operations(12,779)(12,157) Interest paid527 Income Taxes paid-(349) Net cash generated from operating activities(12,726)(12,499) CASH FLOW FROM INVESTING ACTIVITIES Interest received403 Purchases of property, plant and equipment(298)(101) Purchases of Intangible assets(425)(638) Acquisition of Other Investments(0)(500) Loans made to third parties- (655) Deposits10,000(10,000) Discontinued operations Net cash provided by/(used in) investing activities9,654(11,894) CASH FLOW FROM FINANCING ACTIVITIES Reimbursements of borrowings and other financial liabilities(12)(7,376) Proceeds from borrowings and other financial liabilities44- Reimbursements of lease liabilities(222)(79) Modifications/terminations Right of Use Assets2- Proceeds from Private Placement via Accelerated Book Building- 14,337 Proceeds from Execution Transactions Warrants-2,832 Interests paid-(1,877) Net cash provided by/(used in) financing activities(188)7,838 NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS(3,261)(16,555) CASH AND CASH EQUIVALENTS at beginning of year33,45750,012 CASH AND CASH EQUIVALENTS at end of year, calculated30,19633,457* RESTATEMENT OF THE YEAR 2022 and HALF-YEAR 2023 Accounting treatment of the transactions with Qliniq Hyloris initially recognized (a) €1 million in revenue in 2022 from the divestment of HY-038, and (b) € 1 million in R&D expenses and € 0,2 million in intangible assets in H1 2023 for the purchase of HY-088. A reassessment determined that both transactions qualify as a non-monetary exchange because negotiations and valuations occurred simultaneously. Due to the development stage of the products exchanged, the fair value of neither the asset received, nor the asset given up can be reliably determined. As a result of this reassessment, the restated financials for 2022 will reverse the €1 million revenue from the divestment of HY-038. This adjustment will also affect the half-year 2023 financial statements, resulting in a reversal of €1 million in R&D expenses for HY-088. These expenses are offset against the €1 million received by Hyloris for HY-038. (See Press Release dated 14th of March 2024 on the restatement for more information) The following tables summarize the impact of the restatement on the consolidated financial statements. Consolidated statement of financial position Per 31 December 2022(in € thousands) Impact of correction of errorAs previously reportedAdjustmentAs restatedCurrent assets50.801-1.00049.801Trade and other receivables5.127-1.0004.127Total assets61.864-1.00060.864 Equity55.045-1.00054.045Result of the period(10.770)-1.000(11.770)Total equity and liabilities61.864-1.00060.864 Consolidated statement of profit or loss and other comprehensive income For the year ended 31 December 2022(in € thousands) Impact of correction of errorAs previously reportedAdjustmentAs restatedRevenues2.951-1.0001.951Gross profit2.857-1.0001.857Operating profit/(loss) (EBIT)(10.638)-1.000(11.638)Profit (loss) before taxes(10.766)-1.000(11.766)PROFIT (LOSS) FOR THE PERIOD(10.770)-1.000(11.770)TOTAL COMPREHENSIVE INCOME FOR THE PERIOD(10.770)-1.000(11.770)For the year ended 31 December 2022(in €) Impact of correction of errorAs previously reportedAdjustmentAs restatedBasic/diluted earnings/(loss) per share(0.380)(0.035)(0.435) Consolidated statement of cash flows Even though there was an actual cash inflow of EUR 1 million from the out-licensing of HY-038 and a cash outflow of EUR 1.2 million resulting from the in-licensing of HY-088, the transactions are presented in the consolidated statement of cash flows for the year ended per December 31, 2023 (i.e., EUR 200k prepaid expenses), as this most faithfully presents the substance of the transactions. There is no impact on the consolidated statement of cash flows for the year ended per December 31, 2022, as no cash inflow occurred yet. Audit Report The statutory auditor, KPMG Bedrijfsrevisoren - Réviseurs d’Entreprises, represented by Olivier Declercq, has informed us that the audit procedures were not yet completed. ONGOING LEGAL PROCEEDINGS In August 2022, AltaThera Pharmaceuticals LLC filed a complaint before the District Court for the Northern District of Illinois against Academic Pharmaceuticals Inc, Dr. Somberg and Hyloris Pharmaceuticals, for (a.o.) alleged misappropriation of AltaThera’s trade secrets and confidential information, improper inventorship, and breach of contract, which seeks (punitive) damages and termination of the agreement whereby Hyloris licenses Sotalol IV to AltaThera (the “Litigation”). Hyloris moved to dismiss the complaint for improper service of process and lack of jurisdiction. Further, in November 2022, Hyloris initiated an arbitration against AltaThera for breach of the same licensing agreement between Hyloris and AltaThera in relation to Sotalol IV, including the failure of AltaThera to use commercially reasonable efforts in selling Sotalol IV as required under the licensing agreement, which seeks damages and termination of the licensing agreement (the “Arbitration”). AltaThera responded and counter-demanded, reasserting its claims from the Litigation. At the end of August 2023, all parties agreed to stipulate to the dismissal of the Litigation and to consolidate the Litigation and the Arbitration before the American Arbitration Association (“AAA”) in New York. Hyloris contests the claims asserted by AltaThera and, based upon Hyloris’ assessment of the documents and expert reports put forward to date by AltaThera to support its claims, Hyloris is of the view that there is no convincing evidence supporting AltaThera’s claims for liability or damages. On the other hand, Hyloris believes strongly in the merits of its claims against AltaThera, and that its position is well supported by its expert reports and other documents and evidence submitted to the arbitration panel. Arbitration hearings are scheduled in April 2024 with a final decision expected by the end of H1 2024. Hyloris remains fully confident about the outcome of this litigation in its favor. Hyloris however cannot guarantee that the outcome of the litigation, even if in its favor, may not have a negative impact on future sales of Sotalol IV. About Hyloris Pharmaceuticals SA Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors. The Company’s development strategy primarily focuses on leveraging established regulatory pathways, such as the FDA’s 505(b)2 pathway in the U.S or equivalent regulatory frameworks in other regions which are specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This approach can reduce the clinical burden required for market entry, and significantly shorten the development timelines, leading to reduced costs and risks. Hyloris has built a broad, patented portfolio of 18 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over existing alternatives. Two products are currently in early phases of commercialization in collaboration with commercial partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. In addition to its core strategic focus, the Company has 1 approved high barrier generic product launched in the U.S. and 2 high barrier generic products in development. Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com and follow-us on LinkedIn. For more information, contact Hyloris Pharmaceuticals:Stijn Van Rompay, CEOstijn.vanrompay@hyloris.com+32 (0)4 346 02 07Jean-Luc Vandebroek, CFOjean-luc.vandebroek@hyloris.com+32 (0)478 27 68 42Jessica McHarguejessica.mchargue@hyloris.com+1 919 451 4740 Disclaimer and forward-looking statements Hyloris means “high yield, lower risk”, which relates to the 505(b)(2) regulatory pathway for product approval on which the Company focuses, but in no way relates or applies to an investment in the Shares. Certain statements in this press release are “forward-looking statements.” These forward-looking statements can be identified using forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company’s control, that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. 1 https://www.aafp.org/pubs/afp/issues/2010/1115/p1209.html2 IQVIA3 https://caddac.ca/about-adhd/4 https://journals.sagepub.com/doi/10.1177/10600280135106995 Not adjusted for inflation6 Based on combination of different sources: population-based study, clinical based study and key opinion leaders' estimation7 Reclassification of the withholding tax on R&D salaries. (payroll tax rebates)8 Reclassification of the loan to third-party from Operating to Investing activities in the Cash flow statement9 Reclassification of deposit from Cash and cash equivalents to Other investment including derivatives for an amount of €10 million in 202210 Reclassification of the withholding tax on R&D salaries. (payroll tax rebates) for an amount of €120k Attachment 20240314 Full Year Results 2023 ENG

U.S. Patent and Trademark Office (USPTO) issues new patent covering Talicia1 as an all-in-one treatment of Helicobacter pylori (H. pylori), supporting Talicia protection until February 12, 2034 This new patent adds to the existing strong intellectual property portfolio protecting Talicia, including composition of matter and other patents and FDA-granted data exclusivities granted under the GAIN QIDP designation and section 505(b)(2) Talicia is the only FDA-approved rifabutin-containing all-in-one therapy for the eradication of H. pylori, providing an optimized antibiotic resistance profile and the leading branded first-line therapy prescribed by U.S. gastroenterologists2 for H. pylori infection, which affects approximately 35% of the U.S. adult population3 TEL AVIV, Israel and RALEIGH, N.C., March 11, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new U.S. patent covering Talicia1 as an all-in-one fixed-dose combination of amoxicillin, omeprazole and rifabutin and its use for the treatment of helicobacter pylori (H. pylori) infection (Patent No. 11,931,463 to be issued March 19, 20244). Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori infection, which affects approximately 35% of the U.S. adult population and this patent is expected to provide protection for Talicia until February 12, 2034. "Talicia is the only FDA-approved rifabutin-containing all-in-one therapy for the eradication of H. pylori. Its components and formulation are optimized to provide patients with the right medications for successful H. pylori eradication with an optimized resistance profile, which is significant in the face of growing microbial resistance to clarithromycin-based regimens," said Patricia Anderson, RedHill's Senior Vice President of Regulatory Affairs. "The granting of this new U.S. patent further adds to the strong intellectual property protecting Talicia, including the recently announced patent for treatment regardless of patient Body Mass Index (BMI), several other composition of matter and other patents, and additional FDA-granted data exclusivities granted under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation and the approval of Talicia under section 505(b)(2)." About H. pylori infection H. pylori is a bacterial infection that affects approximately 35% of the U.S. population, with an estimated two million patients treated annually5. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the World Health Organization (WHO) as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer6 and a major risk factor for peptic ulcer disease7 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma8. More than 27,000 Americans are diagnosed with gastric cancer annually9. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies. About Talicia Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. Food and Drug Administration (FDA) for the treatment of H. pylori infection in adults. Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address H. pylori's high resistance to other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted American College of Gastroenterology, the FDA and the WHO in recent years. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent10 to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm11. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide. TALICIA: IMPORTANT SAFETY INFORMATION Tell your healthcare provider about all of the medicines you take, including prescription or non-prescription medications or herbal supplements before starting Talicia. Talicia may affect the way other medicines work, and other medicines may affect the way Talicia works. Do not start any new medications while taking Talicia without first speaking with your healthcare provider. You should not take Talicia if you are known to be sensitive to any of the components of Talicia (omeprazole, amoxicillin, rifabutin), penicillins, proton pump inhibitors or rifamycins. You should not take Talicia if you are taking rilpivirine-containing products, delavirdine or voriconazole. Before you take Talicia, tell your healthcare provider about all of your medical conditions, including if you: Are pregnant or plan to become pregnant. Talicia may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during your treatment with Talicia. Have severe kidney disease or liver disease. When taking Talicia, do not crush or chew capsules. Do not take Talicia with alcohol. Call your healthcare provider immediately if while taking Talicia you develop: New rash or other skin changes, muscle or joint pains, swelling of any area of the body, severe flu-like symptoms, difficulty breathing, fever, blood in your urine, increased or decreased urination, drowsiness, confusion, nausea, vomiting, ongoing stomach pain, bloody diarrhea, or if diarrhea continues after therapy is completed, weight gain or changes in your eyesight. What are the common side effects of Talicia? The most common side effects of Talicia are diarrhea, headache, nausea, stomach pain, rash, indigestion, mouth or throat pain, vomiting, and vaginal yeast infection. Call your healthcare professional for medical advice about side effects. Tell your healthcare provider if you experience tiredness, weakness, achiness, headaches, dizziness, depression, increased sensitivity to light, or pain when taking a deep breath. Talicia may reduce the effectiveness of oral or other forms of hormonal birth-control. You should use an additional non-hormonal highly effective method of birth control while taking Talicia. You may experience a brown-orange discoloration of your urine or tears while taking Talicia. The information here is not comprehensive. Talk to your healthcare provider to learn more. APPROVED USE FOR TALICIA TALICIA is indicated for the treatment of Helicobacter pylori infection in adults. Click here for the full Prescribing Information for TALICIA. You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or the FDA at 1-800-FDA-1088 or . About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults1, and Aemcolo®, for the treatment of travelers' diarrhea in adults12. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first -in -class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease. More information about the Company is available at / twitter.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements, including, but not limited to, statements regarding the intended use of net proceeds from the offering, may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the risk that the Company will not comply with the listing requirements of the Nasdaq Capital Market ("Nasdaq") to remain listed for trading on Nasdaq, the addition of new revenue generating products, out-licensing of the Company's development pipeline assets, timing of opaganib's development for Acute Radiation Syndrome, non-dilutive development funding from RHB-107 and its inclusion in a key platform study. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, market and other conditions, the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication, the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107, the risk that HB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required, as well as risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 28, 2023. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Category: Commercial 1 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . 2 IQVIA XPO Data on file 3 Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. 4 Patent issued by The United States Patent and Trademark Office (USPTO), the federal agency for granting U.S. patents and registering trademarks. 5 IQVIA Custom Study for RedHill Biopharma, 2019 6 Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497. 7 NIH – Helicobacter pylori and Cancer, September 2013. 8 Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15. 9 National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER). 10 Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose. 11 The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001). 12 Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: . Logo: SOURCE RedHill Biopharma Ltd.

On an Intent-to-Treat Analysis, Co-Primary Symptom Endpoint Met, Statistical Significance (P<0.025) Multiple Secondary Symptom Endpoints Met, Statistical Significance (P<0.025) On an Intent-to-Treat Analysis, Co-Primary Sign Endpoint and Secondary Sign Endpoints Not Met PL9643 Demonstrated Superiority Over Vehicle in Multiple Sign Endpoints Excellent Safety and Tolerability Pro > Future Discussions Planned with FDA Regarding Regulatory Approval Path Company to Host Conference Call at 8:30 a.m. ET Today CRANBURY, N.J., Feb. 28, 2024 /PRNewswire/ --Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced results for its PL9643 MELODY-1 pivotal Phase 3 clinical trial evaluating the safety and efficacy of PL9643 versus vehicle in the treatment of dry eye disease (DED). MELODY-1 had two co-primary efficacy endpoints: one clinical symptom (pain) and one clinical sign (conjunctival lissamine green staining), as well as multiple other symptom and sign secondary endpoints of DED. Duration of treatment was 12 weeks with a 4-week run-in period. Analysis of the data indicated that both age and sex needed to be accounted for in the primary statistical analysis, (60% of the subjects were over age 60; 68% of the subjects were female). After adjusting the Intent-to-Treat (ITT) analysis for age and gender, PL9643 treatment demonstrated clinically meaningful (visual analog score reduction of >10 points from baseline) and statistically significant results for the co-primary symptom endpoint of pain (p<0.025) and multiple other symptom endpoints. PL9643 treatment for the co-primary sign endpoint and secondary sign endpoints demonstrated positive treatment effects over vehicle in the ITT population but did not achieve statistical significance. In the unadjusted planned analyses, the co-primary endpoints and secondary endpoints did not reach statistical significance. "Even with a high vehicle response, PL9643 treatment was clinically meaningful and statistically significantly effective on an ITT basis in reducing patient symptoms for the co-primary pain endpoint and multiple other symptom endpoints," said Carl Spana, Ph.D., President and CEO of Palatin. "We are pleased that PL9643 treatment demonstrated excellent safety and tolerability data, including superior efficacy results compared to vehicle across multiple sign endpoints." "It is important to note that it is rare for one clinical study in DED to show efficacy for both a sign and a symptom. While additional analyses are ongoing, the initial results reinforce the potential of PL9643 as a treatment to address both symptoms and signs of DED," continued Dr. Spana. "Our comprehensive data analysis is ongoing, and upon completion, we plan to meet with the FDA to discuss and get feedback on the design of the next pivotal Phase 3 clinical trial. Furthermore, we will continue with our efforts for a collaboration partner for our DED program." Safety analysis indicated PL9643 was well-tolerated. There were fewer ocular treatment related adverse events in the PL9643 arm (5.6%, N=16/288) compared to vehicle (6.3%, N=18/287), and fewer study discontinuations in the PL9643 arm (7.0%, N=20/288) compared to vehicle (11.1%, N=32/287). PL9643 represents an opportunity to bring relief to dry eye sufferers. While DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed and less than 10% of those diagnosed are treated with a prescription product. This shows the significant unmet medical need for an effective treatment that also has an excellent safety and tolerability profile.1 The data from the pivotal Phase 3 MELODY-1 trial was a multi-center, randomized, double–masked and vehicle–controlled study that enrolled 575 patients at sites in the U.S. The trial evaluated the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in patients with moderate-to-severe DED, for multiple sign and symptom endpoints, after treatment for 12 weeks. The study design was based on positive Phase 2 results of PL9643 for the treatment of DED, and an end-of-Phase 2 meeting with the FDA on key elements of the pivotal Phase 3 clinical program. Conference Call / Webcast Palatin will host a conference call and audio webcast on February 28, 2024, at 8:30 a.m. Eastern Time to discuss the PL9643 Phase 3 clinical study results in greater detail. Individuals interested in listening to the conference call live can dial 1-888-506-0062 (US) or 1-973-528-0011 (International), Participant Access Code: 295124. The audio webcast and replay can be accessed by logging on to the "Investor-Webcasts" section of Palatin's website at or by clicking here. A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone replay, dial 1-877-481-4010 (US) or 1-919-882-2331 (International), Replay Passcode 50021. The webcast and telephone replay will be available through March 13, 2024. About Dry Eye Disease (DED) Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. DED affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for DED is generally regarded as inadequate by many physicians and patients, and often requires weeks or months to demonstrate activity. References 1. Market Scope 2023 Dry Eye Product Market Review; does not include OTC artificial tears and other Rx anti-inflammatory and tear stimulants. About Melanocortin Receptor Agonists and Inflammation The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MCR1 through MCR5. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. To learn more about Palatin, please visit us on and follow us on Twitter at @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, including PL9643, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory agencies and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. Company Codes: AMEX:PTN