CSF-1R

Mithra reports full year 2023 financial results Revenues were EUR 40.2 million, down from the 2022 result of EUR 67.0 million which was positively impacted by exceptional upfront cash payments from partnerships.Product sales were EUR 18.7 million, up +19.3% vs EUR 15.7 million in 2022.ESTELLE® product sales reached EUR 10.4 million in 2023 beating the September 2023 guidance of EUR 8.5 million and up from EUR 9.2 million in 2022.Cash position, at EUR 9.0 million at end of 2023, is down compared to previous year (EUR 28.3 million end 2022).In an effort to maximize value for all of Mithra’s stakeholders, the Company has initiated a Monetization Process to realize value from its assets involving the sale of various selected assets, particularly Estetra SRL (which includes the US DONESTA® out-licensing process), and/or the business as a whole.The delay in the DONESTA® US NDA filing negatively impacted the process to consummate a US licensing agreement, also negatively impacting expected revenues.Triggered by the monetization process, management recognized an impairment loss of EUR 74.1 million on two of those assets (namely the Mithra CDMO and ZORELINE®). This accounting conclusion does not affect the management’s commitment to continue to find the best possible outcome for those assets. Due to these impairments (non-cash items), among other factors, the net loss for the period was EUR 173.5 million.Post-closing events include the 06 February 2024 announcement of Mithra’s cash position of EUR 6.5 million, the 15 February 2024 sale of balance of shares held in Mayne Pharma for approximately EUR 12.8 million, the 05 March 2024 announcement of up to EUR 18.5 million bridge facility to initiate a monetization process of key Mithra assets, and the 05 March 2024 change of management announcement. Liege, Belgium, 08 March 2024 – 7:00 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its financial results for the year which ended on 31 December 2023, prepared in accordance with IFRS. Financial Highlights See "Note regarding basis of preparation" on page 5 below. FY 2023 revenues were EUR 40.2 million compared to EUR 67.0 million in 2022.Out-licencing revenues at EUR 19.0 million were mostly driven by ESTELLE® in 2023. On top of EUR 3.75 million invoiced to our partner Fuji, another EUR 12.5 million has been recognized as revenue according to our IFRS 15 accounting policy (respectively EUR 2.5 million with Gedeon Richter for China and EUR 10.0 million with Fuji). Balance of out-licencing was primarily for DONESTA® with EUR 1.5 million invoiced to our partner Searchlight and EUR 1.13 million recognized under IFRS for China and Israel.ESTELLE® product sales, at EUR 10.4 million, were above 2022 level (EUR 9.2 million) and above our latest guidance (EUR 8.5 million) given in September. This is due to, amongst other items, our first deliveries to our Japan partner Fuji Pharma.Total number of cycles of ESTELLE® (NEXTSTELLIS®) sold by our partner in the US Mayne Pharma increased +136% to 385k cycles. The increase in sales is expected to continue in 2024.ESTELLE® cycle sales in Europe (DROVELIS® and LYDISILKA® brand names) increased by 103% to 3.2 million cycles in 2023.Novalon sales of generic products, including MYRING®, TIBELIA® and DAPHNE®, were EUR 8.1 million in 2023, up by +28% compared to the previous year while R&D contracting revenue from our CDMO remained steady at EUR 2.4 million.Cash collection from out-licensing milestones totalled EUR 56.4 million in 2023; EUR 51.5 million from DONESTA® (EUR 50.0 million from Gedeon Richter, out of which EUR 39.7 million was recognized in 2022 according to IFRS 15 and EUR 1.5 million from Searchlight); EUR 4.8 million from ESTELLE® (EUR 3.8 million from Fuji Pharma and EUR 1.0 million from Gedeon Richter for two LATAM territories previously recognised under IFRS).R&D expenses (excluding depreciation) decreased slightly (EUR 52.9 million in 2023 versus EUR 53.7 million in 2022) coming in below the guidance of EUR 60 million given in May 2023. The stable level of spend is a product of the continued strategy to focus on core R&D projects (DONESTA® and ESTELLE®) and discontinuing or pausing other research activities outside Mithra’s core scope.REBITDA was EUR -48.2 million in 2023 compared to EUR -12.3 million in 2022 year mostly due to lower out-licencing revenue and, to a lesser extent, an increase in G&A expenses and lower other operating income.Share-based payments expenses include the one-time (non-cash) expense of EUR 4.1 million relating to the 20 million warrants issued to Armistice Capital, LLC; the remaining being the balance of costs relating to previously awarded plans.Impairment on non-current assets: due to current cash runway situation, focus for non-core assets has now shifted to short-term sale or disposal. Accordingly, an impairment loss of EUR 74.1 million for two such assets has been recorded in FY 2023 financial statements: EUR 47.7 million for Mithra CDMO and EUR 26.4 million for ZORELINE®. This accounting conclusion does not affect the management’s commitment to continue to find the best possible outcome for those assets.Deferred tax assets: Balance of deferred tax assets previously recognized within Mithra CDMO and Novalon have been reversed as essentially relating to expected future taxable profit of ZORELINE®, now most likely to be sold in the short term.Cash position, at EUR 9.0 million at end 2023, is down compared to previous year (EUR 28.3 million end 2022) as revenue cash collection, capital increases and draw-down on existing financing lines did not compensate for expenses as well as reimbursement of several credit lines with some of our lenders.Equity was EUR -103.2 million at the end of 2023, down EUR 136.9 million compared to end 2022 (EUR 33.7 million). The total comprehensive loss for the period (EUR 167.1 million) was only partially compensated by a capital increase of EUR 2.5 million with Highbridge and Whitebox, a loan conversion by a lender under the convertible loan facility (EUR 1.2 million) and several contributions in kind against the issuance of new shares for interest to the lenders for a total of EUR 3.5 million (net of transaction costs) and by the private placement in equity with Armistice Capital LLC for EUR 18.4 million (net of transaction costs of EUR 1.6 million). Operational highlights Mithra announced positive preclinical data from its CSF-1R inhibitor program following the earlier announcement of its initial pre-clinical study successes. This was achieved in partnership with BCI Pharma and focused on tyrosine kinases inhibitors, a new development axis in the treatment of many pathologies including endometriosis, oncology and inflammatory disorders. Mithra announced promising topline safety results from DONESTA® Phase 3 Study in North America positive topline safety results for its E4 COMFORT clinical trial in the United States and Canada aiming at evaluating the efficacy and safety of DONESTA® for the treatment of Vasomotor Symptoms (VMS) in post-menopausal women.Mithra and the University of Liège secure proof-of-concept for novel manufacturing process of E4 delivering an improved manufacturing methodology to boost robustness and productivity while ensuring a limited environmental footprint. The new metal-free process is based on the thermolysis of a key sulfoxide derivative of estrone.Mithra granted an additional patent for NEXTSTELLIS® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets) in the United States by the United States Patent and Trademark Office. The new patent will provide NEXTSTELLIS® contraceptive with oral-dosage-unit protection in the US market until 2036. The patent is a continuation of U.S. Patent No. 11,147,771 and was listed in the FDA’s Orange Book.Mithra received guidance from the FDA for the DONESTA® NDA marketing authorization filing in the US and received positive DSMB opinion on the DONESTA® European Phase 3 trial. Mithra received feedback regarding its new drug application (NDA) marketing authorization filing for DONESTA® in the United States. This follows an agreement in principle with the FDA for Mithra to conduct additional endometrial data analyses with a formal NDA submission now planned for Q4 2024 to allow for the time required to perform these additional analyses pursuant to FDA guidance. Pending regulatory approval, DONESTA® is expected to target a US market of nearly 63 million women between the ages of 45 and 65 years-old and experiencing vasomotor symptoms of menopause (VMS). Mithra also received a positive review from the independent Data and Safety Monitoring Board (DSMB) on its phase 3 program for DONESTA®.Mithra completed its pediatric study of ESTELLE® in adolescent patients, evaluating the safety, compliance, and pharmacokinetic profile of ESTELLE® in more than 100 participants aged 12 to 17 years old. The primary endpoint of the study, which was conducted in Estonia, Finland, Georgia, Latvia, Poland and Sweden, was to evaluate the safety of ESTELLE® in post-menarchal subjects.Mayne Pharma and Mithra announced the US launch of HALOETTE®, a vaginal hormonal contraceptive ring, resulting in a EUR 1.6 million milestone payment. HALOETTE® is a generic version of NUVARING®. According to IQVIA, NUVARING® US brand and generic sales were approximately USD 564 million for the 12 months ended November 2022.Mithra signs license agreement for the commercialization of DONESTA® with Gedeon Richter, Searchlight and Rafa Laboratories expanding its potential reach to Canada, Israel, Europe, the CIS countries, Latin America, Australia and New Zealand.Mithra received EUR 3.75 million milestone payments from Fuji Pharma under its ESTELLE® licensing agreement in Japan. A payment of EUR 1.25 million was triggered by completion of the interim clinical study reports of Phase 3 trials investigating ESTELLE® for the treatment of patients with dysmenorrhea or endometriosis. An additional EUR 2.5 million payment was made in October following the submission of an application for marketing approval in Japan in a drive to help combat dysmenorrhea.Mithra and Gedeon Richter signed a supply agreement for production of API for ESTELLE® and DONESTA® in August. The agreement specifies that Gedeon Richter will manufacture and supply the Estetrol (E4) native estrogen for Mithra’s leading products.Mithra and Gedeon Richter signed a binding Head of Terms to commercialize ESTELLE® and DONESTA® in China. Upon the finalization of the license agreements, Gedeon Richter will have the exclusive commercial rights for both products in China. Under the head of terms, Gedeon Richter to perform and fund the clinical studies required to obtain marketing approvals in China; upon the closing of the two licencing agreements, Mithra to receive a combined milestone payment of EUR 4.5 million. Events beyond the reporting period Mithra provided an update on its current cash position and its plans to address its runway and creating and optimizing value for all its stakeholders on 06 February, 2024. Announced the sale of all 4,221,815 shares it held in Mayne Pharma Group Limited on 15 February 2024. The shares were sold at a price of A$ 5.03 per share for aggregate net proceeds of A$ 21,129,551 (approx. EUR 12.8 million).Reported the last patient-out in the DONESTA® C301 Endometrial Safety Study. was reached on 8 February 2024. This marks the completion of patient treatments and the initiation of the data management/reporting phase.On 05 March 2024, Mithra announced the initiation of a monetization process and signing of a new secured bridge loan facility expected to fund that process through 30 April. The monetization process and Facility are further to Mithra’s 06 February 2024 announcement on its cash position. In an effort to maximize value for all of Mithra’s stakeholders, the Company has initiated a monetization process to realize value from its assets involving the sale of various selected assets, particularly Estetra SRL, and/or the business as a whole. The Company is finalizing negotiations with an internationally recognized investment bank to help conduct the Monetization Process in collaboration with DC Advisory and Alvarez & Marsal, who are advising on liquidity management and advising on monetization, among other things. Parties interested in participating in the Monetization Process should contact Ed Kulik of DC Advisory (Ed.Kulik@dcadvisory.com) and Thomas Dillenseger of Alvarez & Marsal (TDillenseger@alvarezandmarsal.com).Management Changes: Appointment of Christophe Maréchal1 and Xavier Paoli as co-CEOs following, 05 March 2024 termination of the management agreement of former CEO. Financial results Note regarding basis of preparation: The consolidated financial results of Mithra Pharmaceuticals SA and its subsidiaries (“Mithra”) included in this release have been prepared in accordance with International Financial Reporting Standards as adopted by the European Union. These include International Financial Reporting Standards (IFRS) and the related interpretations issued by the International Accounting Standards Board (IASB), and the IFRS Interpretations Committee (IFRIC), effective at the reporting date and adopted by the European Union. These consolidated financial results have been prepared on the basis of a going concern. However, as announced on 06 February 2024 and 05 March 2024, there are material uncertainties about Mithra's ability to continue in operation beyond 30 April 2024. As of 07 March 2024, Mithra has approximately EUR 9.0 million in cash and cash equivalents including the first drawdown under the bridge facility. Its lenders have provided a committed bridge facility of up to EUR 13.5 million, plus an uncommitted "accordion" facility for a further EUR 5 million, in each case subject to milestones, as described in that 05 March 2024 press release, in order to fund a monetization process. However, as noted in that release there is a risk that Mithra will not be able to draw the full amount, for instance if it is not able to initiate a Monetization Process. Even if a Monetization Process is initiated, there is a material risk that that process will not be successful, in whole or in part, or may not significantly reduce Mithra's existing indebtedness. If Mithra is not able to draw funds under the new bridge facility or is otherwise not able to raise or generate sufficient cash, this will adversely affect Mithra's continued operations and ability to operate as a going concern. 1. Consolidated statement of profit or loss Thousands of euro (€)20232022 Revenue40,15566,997Cost of sales(21,950)(19,623)Gross profit18,20547,374Research and development expenses(63,170)(64,041)General and administrative expenses(22,085)(14,675)Selling expenses(2,271)(2,100)Impairment on non-current assets(74,147)-Other operating income4,3367,196Loss from operations(139,132)(26,245)Change in fair value of contingent consideration payable(1,510)28,335Net fair value gains/(losses) on financial assets at fair value through profit or loss--Financial income1,7459,852Financial expenses(22,899)(23,422)Loss before taxes(161,795)(11,480)Income taxes(11,707)(48,139)NET LOSS FOR THE PERIOD(173,502)(59,620) 2. Consolidated statement of financial position As at 31 DecemberThousands of euro (€)20232022ASSETS Property, plant and equipment13,40540,717Right-of-use assets38,08365,534Goodwill5,2335,233Other intangible assets108,713134,905Deferred income tax assets1,28916,354Contract assets1792.828Derivatives financial assets349-Investment in equity securities16,01521,437Other non-current assets9,8749,544Non-current assets193,139296,552 Inventories48,28950,312Contract assets19,53644,988Derivatives financial assets47-Trade and other receivables16,55622,277Other short-term deposits--Cash and cash equivalents8,98028,285Current assets93,408145,863 TOTAL ASSETS286,546442,414 As at 31 DecemberThousands of euro (€)20232022EQUITY AND LIABILITIES Share capital50,59441,228Additional paid-in-capital424,858408,647Other reserves10,586(19,934)Accumulated deficit(589,294)(396,254)Equity attributable to equity holders(103,255)33,687 Subordinated loans9,79110,710Other loans137,739127,052Lease liabilities31,63138,253Refundable government advances7,6478,127Other financial liabilities73,73174,210Derivatives financial liabilities13,63615,261Contract liabilities10,300-Provisions266266Deferred tax liabilities1,0814,420Non-current liabilities285,822278,298 Current portion of subordinated loans1,2521,252Current portion of other loans19,00145,980Current portion of lease liabilities6,4505,179Current portion of refundable government advances2,5071,417Current portion of other financial liabilities15,69815,959Derivatives financial liabilities-2,561Trade and other payables59,07258,082Current liabilities103,981130,431 TOTAL EQUITY AND LIABILITIES286,546442,414 3. Consolidated statement of cash flows As at 31 DecemberThousands of euro (€)20232022Cash and cash equivalents at beginning of year28,28532,872Net cash (used in)/ provided by operating activities(2,184)(56,819)Net cash (used in)/ provided by investing activities3,452(25,490)Net cash (used in)/provided by financing activities(20,538)77,869Net increase/(decrease) in cash and cash equivalents(19,270)(4,440)Effects of exchange rate changes on cash and cash equivalents(35)(147)Cash and cash equivalents at end of period8,98028,285 Statement of profit and loss The Group reported a net loss of EUR 173.5 million in 2023, compared to a net loss of EUR 59.6 million in 2022. The main contributor to this difference was an impairment loss of EUR 74.1 million registered on the value of Mithra CDMO and ZORELINE® assets. Revenues were EUR 40.2 million compared with EUR 67.0 million in 2022. The revenues breakdown as follows: Overall product sales of EUR 18.7 million were largely driven by ESTELLE® (EUR 10.4 million), which are higher than in 2022 (EUR 9.2 million) and MYRING® (EUR 6.0 million) that improves the revenue on our generic portfolio to EUR 8.3 million compared to EUR 6.5 million in 2022.Out-licensing revenue for the year was EUR 19 million from ESTELLE® and DONESTA® milestones (EUR 16.3 million and EUR 2.6 million, respectively). For ESTELLE®, on top of EUR 3.75 million invoiced to our Partner Fuji, another EUR 12.5 million has been recognized as revenue according to our IFRS 15 accounting policy (respectively EUR 2.5 million with Gedeon Richter for China and EUR 10.0 million with Fuji). Balance of out-licencing was primarily for DONESTA® with EUR 1.5 million invoiced to our partner Searchlight and EUR 1.13 million recognised under IFRS for China and Israel.Revenues from the R&D contracting activities of the CDMO were stable at EUR 2.4 million compared to EUR 2.3 million in 2022. R&D expenses (including depreciation) decreased slightly to EUR 63.2 million. The stable level of research expenses is due to the continued focus on our core R&D projects, namely the DONESTA® Phase II and III clinical studies and the ESTELLE® post-approval safety study (PASS). G&A and selling expenses increased +44% to EUR 24.4 million due to a higher impact of share-based payments accounting entries (charge of EUR 4.5 million compared to charge of EUR 2.0 million in 2022); increase in professional services to assist us in our attempt to strengthen our balance sheet and refocus on innovative R&D, but also relating to administration of our financial liabilities and uncomfortable cash position; and, to a lesser extent, an increase in insurance costs and salaries indexation. Impairment on non-current assets: as focus for non-core assets has now shifted to short-term sale or disposal of those assets, an impairment loss of EUR 74.1 million for two such assets has been recorded in FY 2023 financial statements: EUR 47.7 million for Mithra CDMO and EUR 26.4 million for ZORELINE®. Other operating income of EUR 4.3 million (compared to EUR 7.2 million in 2022) mostly consists of an R&D tax credit for EUR 1.3 million which is directly related to R&D expenses level and of EUR 1.4 million exemption from the withholding tax on professional income for R&D staff. Main reason for lower other operating income is that last year included a reinvoicing of costs of EUR 2.2 million that did not repeat in 2023. The negative impact of approximately EUR -1.5 million for change in fair value related to contingent consideration payable ESTELLE® is the consequence of the update of both the discount rate and the timing effect. The decrease in financial income to EUR 1.7 million from EUR 9.9 million in 2022 is explained by the lower impact of the remeasurement of refundable government advances measured at amortized cost following the update of forecasts (EUR 0.5 million in 2023 vs EUR 3.6 million last year). Last year also included EUR 3.0 million of dividend from Mayne Pharma as well as a realized gain of EUR 2.5 million following the early repurchase of EUR 34.1 million tranche of our convertible bonds due in 2025 at a discount to par, via the convertible loan signed with Highbridge Capital Management, LLC (“Highbridge“) and funds managed by Whitebox Advisors, LLC (“Whitebox”). Financial expenses remained stable compared to last year, albeit at a high level. The group recorded a tax loss of EUR -11.7 million for 2023 as the balance of deferred tax assets previously recognised within Mithra CDMO and Novalon have been reversed as essentially relating to expected future taxable profit of ZORELINE® now most likely to be sold in the short term. Statement of financial position Assets As of 31 December 2023, the statement of financial position shows a total of EUR 193.1 million in non-current assets-- the majority of which are other intangible assets (EUR 108.7 million); right-of-use assets (EUR 38.1 million); investments in equity securities (EUR 16.0 million); property, plant and equipment (EUR 13.4 million) and deferred tax assets (EUR 1.3 million). In 2023, new additions to the other intangible assets have been limited to a total of EUR 4.2 million (EUR 33.3 million in 2022) and almost offset by EUR 3.5 million of depreciation. Main change of 2023 was the result of the impairment testing of our CDMO and ZORELINE® that led to a one-time depreciation of EUR 27.0 million (EUR 0.6 million and EUR 26.4 million respectively for the CDMO and ZORELINE®). The same impairment testing also led to a one-time depreciation of EUR -47.2 million on our CDMO Tangible fixed assets (Property, plant and equipment and the right-of-use assets). Otherwise, limited additions during the year (EUR 1.2 million) were more than offset by depreciation of the period (EUR 8.2 million). Deferred tax assets decreased to EUR 1.3 million as balance of deferred tax assets previously recognised within Mithra CDMO and Novalon have been reversed as essentially relating to expected future taxable profit of our complex therapeutics products now most likely to be sold in the short term. Contract assets amount decreased to EUR 19.7 million (non-current and current) versus EUR 47.8 million in 2022. New contract assets recognized (essentially EUR 10 million for Fuji and EUR 3.5 million relating to ESTELLE® & DONESTA® in China) were more than offset by unbilled revenues recognised in prior year(s) and invoiced in 2023 (EUR 40.7 million for Gedeon Richter). Current assets at the end of 2023 are about EUR 93.4 million and include, besides contract assets explained here above, Cash and cash equivalents of EUR 9.0 million, Trade & other receivables of EUR 16.6 million, and Inventories of EUR 48.3 million. Equity and liabilities Total equity at year-end is negative at EUR -103.3 million as the total comprehensive loss for the period (EUR 167.1 million) was only partially compensated by several capital increases for a total amount of EUR 25.6 million (net of transaction costs). Non-current liabilities increased to EUR 285.8 million at the end of 2023, compared to EUR 278.3 million end of 2022. The main changes during the period relate to the access in June 2023 to a new tranche of the amended loan facility concluded with funds managed by Highbridge and Whitebox (“Convertible loans” in the above table) for an amount of EUR 12.5 million and the recognition of a contract liability of EUR 10.3 million with Gedeon Richter for DONESTA®. Current liabilities decreased to EUR 104.0 million at the end of 2023, compared to EUR 130.4 million in 2022. The decrease of the Current liabilities is mainly explained by the reimbursement of straight loans at maturity for an amount of EUR 26.8 million. Alternative performance measures Mithra uses some alternative performance measures (APMs) that are not defined in IFRS but that provide helpful additional information to better assess how the business has performed over the period. Mithra decided to use REBITDA and EBITDA in order to provide information on recurring items, but those measures should not be viewed in isolation or as an alternative to the measures presented in accordance with IFRS. REBITDA is an alternative performance measure calculated by excluding the non-recurring items and the depreciation & amortization from EBIT (loss from operations) from the consolidated statement of profit or loss prepared in accordance with IFRS. The Group considers share-based payments as non-recurring item above EBITDA. EBITDA is an alternative performance measure calculated by excluding the depreciation and amortization from EBIT (loss from operations) from the consolidated statement of profit or loss prepared in accordance with IFRS. Financial highlights are presented as follows in the first section of this press release (management figures): Year ended 31 DecemberThousands of euro (€)20232022 Revenue40,15566,997Cost of sales(21,189)(19,112)Gross profit18,96647,886Research and development expenses(52,869)(53,668)General and administrative expenses(16,450)(11,707)Selling expenses(2,213)(2,029)Other operating income4,3367,196REBITDA(48,231)(12,322)Share-based payments expenses(4,540)(1,983)EBITDA(52,771)(14,305)Depreciation(12,214)(11,940)Non-recurring items(74,147)-Loss from operations(139,132)(26,245)Change in fair value of contingent consideration payable(1,510)28,335Net fair value gains/(losses) on financial assets at fair value through profit or loss--Financial income1,7459,852Financial expenses(22,899)(23,422)Loss before taxes(161,795)(11,480)Income taxes(11,707)(48,139)NET LOSS FOR THE PERIOD(173,502)(59,620) Please refer to the table below for the reconciliation to loss from operations as presented within consolidated statement of profit or loss: Year ended 31 DecemberThousands of euro (€)20232022Loss from operations(139,132)(26,245)Depreciation12,21411,940Non-recurring items – impairment charges on non-current assets74,147-Share-based payments expenses4,5401,983REBITDA(48,231)(12,322)Share-based payments expenses(4,540)(1,983)EBITDA(52,771)(14,305) Annual report 2023The auditor, BDO Réviseurs d’Entreprises SRL, has stated that the statutory audit is still ongoing as of the date of this press release. Based on the unfinished status of the audit procedures and the uncertainty about the evolution of the group in the coming weeks, the auditor is not yet able to provide information on the audit opinion he intends to issue on the consolidated financial statements. Financial CalendarThe following are anticipated dates in the Company's 2024 financial calendar and subject to change: 16 April 2024: 2023 Annual Report16 May 2024: Annual General Shareholders’ Meeting26 September 2024: Half Year Report 2024 For more information, please contact: Mithra Pharmaceuticals SAAlex Sokolowski, PhDHead of IR & Communicationsinvestorrelations@mithra.com +32 (0)4 349 28 22Frédérique Depraetere Communications Directorinfo@mithra.com+32 (0)4 349 28 22 About Mithra Mithra Pharmaceuticals SA (Euronext: MITRA) is a Belgian biopharmaceutical company dedicated to transforming women’s health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill ESTELLE®, Mithra is now focusing on its second product DONESTA®, the next-generation hormone therapy. Mithra also offers partners a complete spectrum of solutions from early drug development, clinical batches and commercial manufacturing of complex polymeric products (vaginal ring, implants) and complex liquid injectables and biologicals (vials, pre-filled syringes or cartridges) at its technological platform Mithra CDMO. Active in more than 100 countries around the world, is headquartered in Liège, Belgium. www.mithra.com ESTELLE®, NEXTSTELLIS®, LYDISILKA®, MYRING®, HALOETTE®, ZORELINE®, TIBELIA® and DONESTA® are registered trademarks of Mithra Pharmaceuticals or one of its affiliates. DROVELIS® is a registered trademark of Richter Gedeon Nyrt. DAPHNE® is a registered trademark of Ceres Pharma. NUVARING® is a registered trademark of Organon NV. Important informationThe contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of 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. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. Subscribe to our mailing list on investors.mithra.com to receive press releases by email or follow us on social media:LinkedIn • X • Facebook 1 Acting through CMM&C SRL. Attachment 2024-03-08_Mithra_Press-release_FY2023-Results_FR

- First PAH Patient Dosed in Ongoing Registrational Phase 3 PROSERA Study - - Inclusion of Japan in Phase 3 PROSERA Study Following CTN Acceptance by PMDA - - Cash, cash equivalents and marketable securities totaled $296 million at year-end 2023 - SAN DIEGO--(BUSINESS WIRE)-- Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced its financial results for the fourth quarter and year ended December 31, 2023, and provided a business update. “We were thrilled to enroll the first patient in the registrational PROSERA Study last year, and we are pleased with the pace of site activations and enrollment into the study,” said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio. “This advancement marks a significant milestone in Gossamer’s journey, and it was made possible due to the tireless efforts of the Gossamer team. We are excited to be one step closer to bringing seralutinib to patients. “Additionally, we believe Gossamer is one of the first companies to take advantage of new Japanese regulatory guidelines, formally issued at the end of last year, to allow for the inclusion of Japanese subjects in our global registrational study of seralutinib without performing a pharmacokinetic bridging study. Subject to final results, PROSERA could form the basis of a Japanese New Drug Application, accelerating the potential commercial availability of seralutinib to PAH patients in Japan and unlocking a valuable geographic market for Gossamer. “Beyond PAH, we remain excited about the potential of seralutinib to treat patients living with other forms of pulmonary hypertension, including pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Patients with PH-ILD are in desperate need of safe and efficacious therapies, with just one therapy approved in the US and no approved therapies available in the rest of the world. We believe seralutinib holds great promise for these patients, and our team is eagerly working through a clinical development plan.” Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor The first PAH patient in the ongoing Phase 3 PROSERA Study was dosed in the fourth quarter of 2023. The Phase 3 PROSERA Study is a global registrational clinical trial in patients with Functional Class II and III PAH. The primary endpoint is change in six-minute walk distance (6MWD) from baseline at week 24. Topline results from the PROSERA Study are expected in the fourth quarter of 2025. The Pharmaceuticals and Medical Devices Agency of Japan, or PMDA, allowed inclusion of Japanese clinical trial sites in the ongoing Phase 3 PROSERA Study. Subject to final clinical trial results, PROSERA could form the basis of a commercial marketing application in Japan. Financial Results for Quarter and Full Year Ended December 31, 2023 Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2023, were $296.4 million. As a result, we expect our current cash, cash equivalents and marketable securities will be sufficient to fund operating and capital expenditures into the first half of 2026. Research and Development (R&D) Expenses: For the quarter ended December 31, 2023, R&D expenses were $30.0 million compared to R&D expenses of $41.5 million for the same period in 2022. R&D expenses for the full year ended December 31, 2023, were $135.3 million compared to $170.9 million for the full year ended December 31, 2022. General and Administrative (G&A) Expenses: For the quarter ended December 31, 2023, G&A expenses were $9.1 million compared to $12.8 million for the same period in 2022. G&A expenses for the full year ended December 31, 2023, were $38.5 million compared to $47.6 million for the full year ended December 31, 2022. Net Loss: Net loss for the three months ended December 31, 2023, was $48.1 million, or $0.21 per share, compared to a net loss of $55.8 million, or $0.59 per share, for the same period in 2022. Net loss for the full year ended December 31, 2023, was $179.8 million, or $1.18 per share compared to a net loss of $229.4 million, or $2.71 per share, for the full year ended December 31, 2022. About Gossamer Bio Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients suffering from, pulmonary hypertension. Forward-Looking Statements Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the anticipated timing of a data readout from our Phase 3 PROSERA Study; expectations on commencing a clinical development program in PH-ILD; the ability to commercial marketing application in Japan pending clinical data; and the expected timeframe for funding our operating plan with current cash, cash equivalents and marketable securities. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamer’s business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from pandemics, including clinical trial delays; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of Gossamer’s clinical trials and preclinical studies for seralutinib; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of seralutinib that may limit its development, regulatory approval and/or commercialization, or may result in clinical holds, recalls or product liability claims; Gossamer’s ability to obtain and maintain intellectual property protection for seralutinib; Gossamer’s ability to comply with its obligations in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may adversely affect our business and financial condition and the broader economy and biotechnology industry; Gossamer may use its capital resources sooner than it expects; and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. GOSSAMER BIO, INC. CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA (UNAUDITED; IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA) Three months ended December 31, Year ended December 31, STATEMENTS OF OPERATIONS DATA: 2023 2022 2023 2022 Operating expenses: Research and development $ 29,970 $ 41,508 $ 135,304 $ 170,919 In process research and development 10,000 15 10,000 65 General and administrative 9,057 12,834 38,455 47,609 Total operating expenses 49,027 54,357 183,759 218,593 Loss from operations (49,027 ) (54,357 ) (183,759 ) (218,593 ) Other income (expense) Interest income 310 594 1,997 1,583 Interest expense (3,239 ) (3,457 ) (13,511 ) (13,880 ) Other income, net 3,808 1,456 15,456 1,512 Total other income (expense), net 879 (1,407 ) 3,942 (10,785 ) Net loss $ (48,148 ) $ (55,764 ) $ (179,817 ) $ (229,378 ) Net loss per share, basic and diluted $ (0.21 ) $ (0.59 ) $ (1.18 ) $ (2.71 ) Weighted average common shares outstanding, basic and diluted 225,409,315 94,280,553 152,621,669 84,574,869 BALANCE SHEET DATA: December 31, 2023 December 31, 2022 Cash, cash equivalents, and marketable securities $ 296,425 $ 255,678 Working capital 254,921 212,650 Total assets 311,916 272,450 Total liabilities 249,147 260,373 Accumulated deficit (1,212,040 ) (1,032,223 ) Total stockholders' equity 62,769 12,077

– BLA filing for axatilimab in chronic GVHD granted Priority Review; PDUFA action date set for August 28, 2024 – – NDA for revumenib in R/R KMT2Ar acute leukemia submitted under FDA's RTOR program; PDUFA date assignment expected in 1Q24 – – Enrollment in AUGMENT-101 mNPM1 patient cohort expected to complete in late 1Q/early 2Q; topline data in 4Q24 – – Initiated revumenib Phase 1 combination trial with 7+3 chemotherapy in newly diagnosed acute leukemias – – Axatilimab Phase 2 IPF trial underway – – $600 million in cash and cash equivalents expected to provide runway through 2026 – – Company to host conference call today at 4:30 p.m. ET – WALTHAM, Mass., Feb. 27, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the fourth quarter and full year ended December 31, 2023, and provided a clinical and business update. "2023 was a landmark year for Syndax marked by execution across all of our major clinical, regulatory, and operational milestones," said Michael A. Metzger, Chief Executive Officer. "With the axatilimab BLA filing under FDA Priority Review and receipt of a PDUFA action date for revumenib anticipated later this quarter, preparations are well underway for the potential launch of both first- and best-in-class drugs later this year. We are committed to maximizing the full potential of these therapies beyond their initial approvals through expansion into earlier lines of therapy in combination with standard of care agents and into new indications. With a strong cash position that is expected to fund operations through 2026, Syndax is well positioned for continued success and long-term growth." Recent Pipeline Progress and Anticipated Milestones Revumenib On December 29, 2023, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for revumenib, a potent, selective small molecule menin inhibitor, for the treatment of adult and pediatric relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia. The NDA submission is being reviewed under the FDA's Real-Time Oncology Review (RTOR) program, and the Company expects to receive a Prescription Drug User Fee Act (PDUFA) action date from the FDA this quarter. The Company expects to complete enrollment in the AUGMENT-101 pivotal trial cohort of patients with R/R mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML) later this quarter or early in the second quarter of 2024. Topline data is expected in the fourth quarter of 2024 and could support a supplemental NDA (sNDA) filing for revumenib in R/R mNPM1 AML in the first half of 2025. Positive results from the Phase 1 and Phase 2 portions of the Company's AUGMENT-101 trial were featured throughout multiple sessions at the 65th American Society of Hematology (ASH) Annual Meeting in December 2023, including results from the pivotal portion of the trial, which were highlighted as a late-breaking oral presentation. At the ASH Annual Meeting and during the Company's accompanying investor event, investigators presented compelling data from multiple Phase 1 combination trials of revumenib in mNPM1 and KMT2Ar acute leukemia across the treatment landscape. The trials are expanding to validate recommended Phase 2 doses, with additional data expected in the second half of 2024. These trials include: BEAT AML: Evaluating the combination of revumenib with venetoclax and azacitidine in front-line AML patients. This trial is being conducted as part of the Leukemia & Lymphoma Society's Beat AML® Master Clinical Trial. SAVE: Evaluating the all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in R/R AML or mixed phenotype acute leukemias. The trial is being conducted by investigators from the MD Anderson Cancer Center. AUGMENT-102: Evaluating the combination of revumenib with fludarabine and cytarabine in patients with R/R acute leukemias. In February 2024, the Company initiated a Phase 1 trial of revumenib in combination with 7+3 chemotherapy followed by maintenance treatment in newly diagnosed patients with mNPM1 or KMT2Ar acute leukemias. The Company plans to initiate a pivotal trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar acute leukemia patients unable to receive intensive chemotherapy by year-end 2024. Enrollment is ongoing in a Phase 1 proof-of-concept clinical trial of revumenib in patients with unresectable metastatic microsatellite stable colorectal cancer. The Company expects to provide an update on the trial in the second quarter of 2024. Axatilimab The FDA has accepted the Biologics License Application (BLA) filing for axatilimab, an anti-CSF-1R antibody, in patients with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. The application has been granted Priority Review and assigned a PDUFA action date of August 28, 2024. Results from the pivotal AGAVE-201 trial were featured in the Plenary Scientific Session at the 65th ASH Annual Meeting in December 2023. The Company exercised its option under its collaboration agreement with Incyte to co-commercialize axatilimab in the U.S. and will provide 30% of the commercial effort. Enrollment is ongoing in a randomized, double-blinded, placebo-controlled Phase 2 trial of axatilimab in patients with idiopathic pulmonary fibrosis (IPF). Incyte plans to initiate two combination trials with axatilimab in chronic GVHD in mid-2024, including a Phase 2 combination trial with ruxolitinib and a Phase 3 combination trial with steroids. Corporate Update In December of 2023, Syndax closed an underwritten public offering of 12,432,431 shares of its common stock at $18.50 per share. This total included the exercise in full by the underwriters of their option to purchase up to 1,621,621 additional shares of common stock. Additionally, the Company issued and sold 2,719,744 shares pursuant to its ATM facility. Aggregate net proceeds from these offerings were approximately $258.1 million after deducting underwriting discounts and sales agent commissions and estimated offering expenses payable by Syndax. Fourth Quarter and Full Year 2023 Financial Results As of December 31, 2023, Syndax had cash, cash equivalents, and short and long-term investments of $600.5 million and 85.1 million common shares and prefunded warrants outstanding. Fourth quarter 2023 research and development expenses increased to $55.1 million from $31.8 million, and for the full year increased to $163.0 million compared to $118.5 million for 2022. The year-over-year increase in research and development expenses was primarily due to increased employee-related expenses and professional fees as well as increased clinical and manufacturing expenses. Fourth quarter 2023 selling, general and administrative expenses increased to $22.8 million from $10.2 million, and for the full year increased to $66.9 million compared to $33.3 million for 2022. The year-over-year increase in selling, general and administrative expenses was primarily due to increased employee-related expenses and professional fees as well as increased commercialization activities for revumenib and axatilimab. For the three months ended December 31, 2023, Syndax reported a net loss attributable to common stockholders of $72.5 million, or $1.00 per share, compared to a net loss attributable to common stockholders of $39.2 million, or $0.62 per share, for the comparable prior year period. For the year ended December 31, 2023, Syndax reported a net loss attributable to common stockholders of $209.4 million or $2.98 per share, compared to a net loss attributable to common stockholders of $149.3 million or $2.46 per share for the comparable prior year period. Financial Guidance For the first quarter of 2024, the Company expects research and development expenses to be $56 to $62 million and total operating expenses to be $82 to $88 million. For the full year of 2024, the Company expects research and development expenses to be $240 to $260 million and total operating expenses to be $355 to $375 million, which includes an estimated $43 million in non-cash stock compensation expense. The Company believes that it has sufficient cash runway to fund its research, clinical development and commercial operations through 2026. Conference Call and Webcast In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Tuesday, February 27, 2024. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website. Alternatively, the conference call may be accessed through the following: Conference ID: Syndax4Q23 Domestic Dial-in Number: 800-590-8290 International Dial-in Number: 240-690-8800 Live webcast: For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company's website at approximately 24 hours after the conference call and will be available for 90 days following the call. About Revumenib Revumenib is a potent, selective, small molecule inhibitor of the menin-KMT2A binding interaction that is being developed for the treatment of KMT2A-rearranged, also known as mixed lineage leukemia rearranged or MLLr, acute leukemias including ALL and AML, and NPM1-mutant AML. Positive topline results from the Phase 2 AUGMENT-101 trial in R/R KMT2Ar acute leukemia showing the trial met its primary endpoint were recently presented at the 65th American Society of Hematology Annual Meeting and data from the Phase 1 portion of AUGMENT-101 in acute leukemia was published in Nature. Revumenib was granted Orphan Drug Designation by the FDA and European Commission for the treatment of patients with AML, and Fast Track designation by the FDA for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation. Revumenib was granted BTD by the FDA for the treatment of adult and pediatric patients with R/R acute leukemia harboring a KMT2A rearrangement. About Axatilimab Axatilimab is an investigational monoclonal antibody that targets colony stimulating factor-1 receptor, or CSF-1R, a cell surface protein thought to control the survival and function of monocytes and macrophages. In pre-clinical models, inhibition of signaling through the CSF-1 receptor has been shown to reduce the number of disease-mediating macrophages along with their monocyte precursors, which has been shown to play a key role in the fibrotic disease process underlying diseases such as chronic graft-versus-host disease (GVHD) and idiopathic pulmonary fibrosis (IPF). Positive topline results from the Phase 2 AGAVE-201 trial showing the trial met its primary endpoint were recently presented at the 65th American Society of Hematology Annual Meeting and Phase 1/2 data of axatilimab in chronic GVHD were published in the Journal of Clinical Oncology. Axatilimab was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with chronic GVHD and IPF. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab. Syndax has exercised its option under the collaboration agreement to co-commercialize axatilimab in the U.S. and will provide 30% of the commercial effort. Axatilimab is being developed under an exclusive worldwide license from UCB entered into between Syndax and UCB in 2016. About RTOR RTOR provides a more efficient review process for oncology drugs to ensure that safe and effective treatments are available to patients as early as possible, while improving review quality and engaging in early iterative communication with the applicant. Specifically, it allows for close engagement between the sponsor and the FDA throughout the submission process and it enables the FDA to review individual sections of modules of a drug application rather than requiring the submission of complete modules or a complete application prior to initiating review. Additional information about RTOR can be found at: About Syndax Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib, a highly selective inhibitor of the menin–KMT2A binding interaction, and axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. For more information, please visit or follow the Company on Twitter and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "believe," "could," "estimate," "expects," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative or plural of those terms, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials, the reporting of clinical data for Syndax's product candidates, the sufficiency of the Company's cash runway to fund its research, clinical development and commercial operations through 2026, the potential use of its product candidates to treat various cancer indications and fibrotic diseases, and Syndax's expected first quarter and full year research and development expenses, and expected first quarter and full year total operating expenses. Many factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; failure of Syndax's collaborators to support or advance collaborations or product candidates; and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Syndax Contact Sharon Klahre Syndax Pharmaceuticals, Inc. [email protected] Tel 781.684.9827 SNDX-G SOURCE Syndax Pharmaceuticals, Inc.