30 sep 25   hemogenyx pharma plc - half-year report hemogenyx pharmaceuticals plc | hemo | 1,148 -12.5 (-1.1%) | mkt cap: 61.5m    rns number : 2914b hemogenyx pharmaceuticals plc 30 september 2025         30 september 2025     hemogenyx pharmaceuticals plc   ("hemogenyx pharmaceuticals" or the "company")     half-year report   interim results for the period ended 30 june 2025   hemogenyx pharmaceuticals plc (lse: hemo), the biopharmaceutical group developing therapies designed to transform blood disease treatment, whose shares are admitted to the equity shares (transition) category of the official list, announces its unaudited interim results for the six-month period ended 30 june 2025.   all financial amounts are stated in gbp british pounds unless otherwise indicated. key highlights ·      first-in-human treatment with hg-ct-1 successfully administered. ·      three patients treated to date in phase i trial; all passed initial safety evaluations with encouraging early signs of efficacy. ·      fda accepted annual ind report for hg-ct-1. ·      pediatric expansion of the phase i trial cleared by fda following protocol amendment. ·      £2.24 million raised in h1 2025 to support ongoing clinical development. fuller details of these developments are contained in the interim management report below. interim management report we are pleased to present the hemogenyx pharmaceuticals half year report for the period ended 30 june 2025. the first half of 2025 has been one of steady and meaningful progress. our principal focus remains the clinical development of hg-ct-1, our fms-like tyrosine kinase 3 ("flt3")-targeted autologous car-t cell therapy for the treatment of relapsed or refractory acute myeloid leukaemia ("r/r aml"). alongside advancing this programme, we have recently strengthened our operational and manufacturing foundations while reducing our operating costs, secured grant and financing support, and positioned the company for potential early revenue generation under an innovative regulatory framework. our mission remains clear: to develop and deliver transformative therapies for patients with life-threatening blood cancers while creating sustainable value for our shareholders. clinical developments the phase i clinical trial of hg-ct-1 in adult r/r aml patients has been our principal focus. during the first half of the year we treated the second adult patient and confirmed in june that both the first and second patients had successfully passed their initial safety evaluations. since the close of the reporting period, we have continued to build momentum, and with the third adult patient being treated in august, thereby completing the first adult dose cohort. we reported that this patient had passed the initial safety evaluation and, importantly, that early signs of clinical efficacy were observed. leukemic cells were no longer detectable by standard assays, providing the first clear evidence that hg-ct-1 is beginning to deliver therapeutic benefit. these achievements reinforced the emerging safety profile of hg-ct-1 at the opening dose level and provided the foundation for continued enrolment. the safety data from the first three patients will now be submitted to the independent data safety monitoring board ("dsmb"), which will determine whether the trial can progress to the next dose level. subject to dsmb approval, we will proceed into dose escalation, a critical milestone in defining both the safety and therapeutic potential of hg-ct-1. during the reporting period we have also prepared to broaden the scope of the trial. a paediatric protocol amendment was submitted in may, and in june regulatory clearance was obtained to initiate a paediatric expansion of the study. this development reflects our determination to address the particularly acute unmet need in childhood aml. operational and manufacturing progress clinical progress must be matched by operational readiness. to that end, we have entered into a strategic manufacturing partnership with made scientific, a us-based contract development and manufacturing organisation, to support technology transfer and scale-up of hg-ct-1 production. this partnership enhances both our capacity and resilience in manufacturing. during the reporting period we also secured a us$120,000 g-rex® grant to optimise and scale car-t production, supporting efficiency and cost-effectiveness as the programme expands. these steps are designed to ensure that hemogenyx pharmaceuticals can meet the growing demands of its clinical trial and be well prepared for potential commercialisation. potential revenue opportunity a significant post-period corporate development has been the signing of a letter of intent ("loi") with cellin technologies oü ("cellin"), a leading estonian cell therapy company. this agreement contemplates the commercialisation of hg-ct-1 under estonia's recently amended hospital exemption pathway for advanced therapy medicinal products. the pathway permits the clinical use of certain advanced therapy medicinal products that have not yet received full marketing authorisation, provided that they are manufactured for and administered within a hospital setting. this collaboration with cellin represents hemogenyx pharmaceutical's first potential near-term revenue opportunity for hg-ct-1, while also offering the prospect of gathering valuable real-world patient data alongside our ongoing clinical trial. the board views this agreement as an important strategic complement to our phase i programme; it provides a pathway to early commercial uptake in europe, strengthens international partnerships, and demonstrates the versatility of hg-ct-1 as both a clinical and potentially commercial asset. financial results during the six months ended 30 june 2025, the group recorded a loss before taxation of £5,006,415 (2024: £2,815,604 loss), including operating costs of £4,819,980 (2024: £2,691,140). for further comparison, the operating costs for the twelve months to 31 december 2024 were £6,465,846. the increase in costs for the period ended 30 june 2025 compared to the same period in 2024 is primarily due to an unfavourable movement in the uk sterling and us dollar exchange rate, which accounted for a variance of approximately £2,241,905. research and development expenditure was broadly consistent year-on-year, with continued investment in the phase i clinical trial of hemo-car-t and related development activities. the outsourcing of manufacture is now more economical than in-house manufacturing and the steps we have taken are now having a significant impact on our operating costs. the company had cash and cash equivalents totalling £226,727 as of 30 june 2025. the company raised £2.24 million (before expenses) during h1 and has raised a further £2.2 million post period end. path forward our priorities for the remainder of 2025 are clear: 1.   dsmb review and dose escalation; submit the combined data from the first three patients to the dsmb and, subject to its approval, advance into the next dose cohort.   2.   paediatric expansion; operationalise the regulatory clearance to initiate enrolment of paediatric patients with aml.   3.   manufacturing scale-up; progress technology transfer with made scientific and deploy the g-rex® grant to strengthen manufacturing efficiency and scalability.   4.   revenue optionality; finalise discussions with cellin to define and implement a framework for hg-ct-1 supply under the estonian hospital exemption pathway, balancing patient access with early revenue generation.   5.   financial discipline; continue to manage resources prudently, aligning financing decisions with clinical and corporate milestones. conclusion the first half of 2025 has confirmed both the safety and the promise of hg-ct-1. the successful treatment of three adult patients at the lowest dose level, together with the first signals of clinical efficacy, mark a pivotal stage in the company's development. with dsmb review and dose escalation moving ahead, and with preparations for paediatric expansion under way, the clinical pathway is well defined. at the same time, the company has built resilience through strengthened manufacturing partnerships, secured targeted grant support, and taken a pragmatic approach to financing. importantly, the loi with cellin opens the possibility of early revenue generation in europe, alongside the collection of meaningful patient data in a real-world setting. we enter the second half of 2025 with momentum and with confidence. our mission remains to deliver life-changing therapies to patients with acute unmet needs, while building long-term value for our shareholders. on behalf of the board, i wish to thank our staff, directors, collaborators, and shareholders for their continued support.   marc feldmann chairman   30 september 2025   market abuse regulation (mar) disclosure   the information contained within this announcement is deemed to constitute inside information as stipulated under the market abuse regulation ("mar") (eu) no. 596/2014, as incorporated into uk law by the european union (withdrawal) act 2018. upon the publication of this announcement, this inside information is now considered to be in the public domain.   enquiries:   hemogenyx pharmaceuticals plc https://hemogenyx.com dr vladislav sandler, chief executive officer & co-founder headquarters@hemogenyx.com peter redmond, director peter.redmond@hemogenyx.com     sp angel corporate finance llp tel: +44 (0)20 3470 0470 matthew johnson, vadim alexandre, adam cowl       peterhouse capital limited tel: +44 (0)20 7469 0930 lucy williams, duncan vasey, charles goodfellow          condensed consolidated interim statement of comprehensive loss for the six months ended 30 june 2025     continuing operations   note 6 months to 30 june 2025 unaudited 6 months to 30 june 2024 unaudited   £ £ revenue  - - administrative expenses  (2,264,292) (2,487,975) foreign exchange gain/(loss)  (2,241,905) 118,520 depreciation  (313,783) (321,685) other losses                   8 (66,552) - operating loss  (4,886,532) (2,691,140) finance income  6 17,328 finance costs  (119,889) (141,792) loss before taxation  (5,006,415) (2,815,604)     loss attributable to:    -     equity owners  (5,004,171) (2,812,832) -     non-controlling interests  (2,244) (2,772) loss for the period  (5,006,415) (2,815,604)   other comprehensive income    items that may be reclassified subsequently to profit or loss:    translation of foreign operations  2,057,106 (102,482)   total comprehensive income for the period    (2,949,309)   (2,918,086)   total comprehensive income attributable to:    -     equity owners  (2,947,065) (2,915,314) -     non-controlling interests  (2,244) (2,772) basic and diluted earnings (per share) 5 (0.833) (0.951)       condensed consolidated interim statement of financial position as at 30 june 2025      as at as at      30 june 2025 31 december 2024     note unaudited audited     assets  £ £     non-current assets        property, plant and equipment 6             588,209               759,408     security deposit              156,773 167,888     right of use asset   10 1,604,440 1,967,813     intangible asset  182,025 477,403     total non-current assets  2,531,447 3,372,512       current assets        trade and other receivables  343,086 679,783     cash and cash equivalents          226,727         159,265     total current assets         569,813         839,048     total assets  3,101,260 4,211,560       equity and liabilities        equity attributable to shareholders        paid-in capital        called up share capital 7         45,935          35,045     share premium 7 22,927,060          21,388,546     deferred share capital 7 13,983,115 13,983,115     warrants reserve 9 - -     other reserves          1,508,572            1,508,572     reverse asset acquisition reserve  (6,157,894)          (6,157,894)     foreign currency translation reserve  1,621,151               (435,955)     retained earnings  (34,428,086)        (29,423,915)     equity attributable to owners of the company    (500,147)            897,514     non-controlling interests  (46,264)               (44,020)     total equity  (546,411)            853,494       liabilities          non-current liabilities      lease liabilities                                                                     10 1,789,831 2,199,413   derivative financial instruments                                           8  535,046 -     current liabilities  2,324,877 2,199,413 trade and other payables                                           909,279 734,980   lease liabilities                                                                    10 413,515 423,673   total current liabilities 1,322,794 1,158,653     total liabilities 3,647,671           3,358,066   total equity and liabilities 3,101,260 4,211,560     the 2025 comparatives are the audited consolidated group accounts for the year ended 31 december 2024 as published on 25 april 2025. condensed consolidated interim statement of changes in equity for the six months ended 30 june 2025 and 30 june 2024                                      called up share capital share premium   deferred share capital     other reserves   reverse acquisition reserve foreign currency translation reserve retained earnings   non- controlling interests total equity  £ £   £   £   £   £ £   £ £ as at 1 january 2024   11,755,660         19,938,556   -   1,164,637        (6,157,894)        (77,496)   (23,804,734)        (37,723)        2,781,006 loss in period - -   -   -   -   - (2,812,832)   (2,772) (2,815,604) other comprehensive income - -     -     -     -     (102,482)              -      -     (102,482) total comprehensive income for the period - -       -       -       -       (179,978) (26,617,566)       (2,772)     (2,918,086) issue of shares 1,662,500 1,662,500 - - - - - - 3,325,000 cost of capital - (164,510) - - - - - - (164,510) issue of options - - - - - - - - -           as at 30 june 2024 (unaudited) 13,418,160         21,436,546   -   1,164,637   (6,157,894)   (179,978)         (26,617,566)   (40,495) 3,023,410 as at 1 january 2025 35,045 21,388,546         13,983,115         1,508,572         (6,157,894)         (435,955) (29,423,915)         (44,020) 853,494 loss in period - -   -   -   -   - (5,004,171)   (2,244) (5,006,415) other comprehensive income - -     -     -     -     2,057,106              -      -     2,057,106 total comprehensive income for the period - -       -       -       -       2,057,106 (5,004,171)       (2,244) (2,949,309) issue of shares 9,940 1,473,267 - - - - - - 1,767,257 cost of capital - (218,803   - - - - - - (218,803)                     issuance of convertible loan notes - 284,050   950 - - - - - 950                     conversion of convertible loan notes 950 -   (950) - - - - - -                     as at 30 june 2025        45,935 22,927,060     13,983,115     1,508,572     (6,157,894)     1,621,151           (34,428,086)     (46,264) (546,411)                         condensed consolidated interim statement of cash flows for the six months ended 30 june 2025         group     note 6 months to 30 june 2025 unaudited 6 months to 30 june 2024 unaudited   £ £ cash flows generated from operating activities    loss for the period  (5,006,415) (2,815,604) depreciation 6, 10 313,783 321,685     foreign exchange gain  3,464 (14,630) interest income  (6) (17,328) interest expense 10 119,889 141,792 change in fair value of derivative liabilities  66,552 - changes in right of use asset and lease liability, net  136,773 - (decrease)/increase in trade and other payables  305,011 (65,400) decrease/(increase) in trade and other receivables  97,799 (17) decrease/(increase) in prepaid and deposits  179,941 98,682 net cash outflow used in operating activities  (3,783,209) (2,350,820)   cash flows generated from financing activities    proceeds from issuance of shares, net of direct costs 7 2,017,898 3,160,490 payment of lease liabilities 10 (345,832) (317,872) net cash flow generated from/(used in) financing activities  1,672,066 2,842,618   cash flows generated from investing activities    interest income  6 17,328 security deposit  (4,007) - intangible assets  267,969 - purchase of property, plant & equipment 6 (3,921)   - net cash flow generated from investing activities  260,047 17,328   net increase (decrease) in cash and cash equivalents    (1,851,096)   509,126   effect of exchange rates on cash and cash equivalents    1,918,558   (113,965)   cash and cash equivalents at the beginning of the period    159,265   1,247,601 cash and cash equivalents at the end of the period  226,727 1,642,762      notes to the condensed consolidated interim financial statements   1.         general information   the group's business is preclinical-stage biotechnology focused on the discovery, development and commercialisation of new medicines and treatments to treat blood and autoimmune diseases as well as certain viral infections. the products under development are designed to address a range of problems that occur with the current standard of care treatments.   the company's registered office is located at 6 heddon street, london, w1b 4bt, and the company's shares are listed on the main market of the london stock exchange.   2.         interim financial information   the condensed consolidated interim financial statements are for the six-month period ended 30 june 2025. the condensed consolidated interim financial statements do not include all the information required for full annual financial statements and should be read in conjunction with the consolidated financial statements of the group for the year ended 31 december 2024, which were prepared under international financial reporting standards (ifrs).   the condensed consolidated interim financial statements have not been audited, nor have they been reviewed by the group's auditors under isre 2410 of the auditing practices board. these condensed consolidated interim financial statements do not constitute statutory accounts as defined in section 434 of the companies act 2006. the group's statutory financial statements for the year ended 31 december 2024 prepared under ifrs have been filed with the registrar of companies. the auditor's report on those financial statements was unqualified and did not contain a statement under section 498(2) of the companies act 2006.   3.         basis of preparation and changes to the group's accounting policies   the principal accounting policies applied in the preparation of these consolidated interim condensed financial statements are set out below. these policies have been consistently applied to all the periods presented, unless otherwise stated.   basis of preparation   the condensed consolidated interim financial statements have been prepared in accordance with ias 34 'interim financial reporting'. the accounting policies adopted in this report are consistent with those of the annual financial statements for the year to 31 december 2024 as described in those financial statements. several new or amended standards became applicable for the current reporting period, but they did not have any impact on the group's accounting policies and did not require retrospective adjustments.   going concern   the preparation of interim financial statements requires an assessment on the validity of the going concern assumption.   during the period to 30 june 2025, the company raised additional funds through a series of equity financings, including the allotment of new ordinary shares and the issuance of convertible loan notes and warrants, providing gross proceeds of approximately £2,236,700. the proceeds raised were used to enable the company to progress towards the testing of hemo-car-t in patients in phase i clinical trials and to provide continuing working capital for the company's operations. a small portion of the funds were used for the development of the company's other product candidates, including the necessary maintenance and prosecution of the company's patent applications.   despite raising further funding of £2,215,799 post period end, the directors expect that the group will have a funding shortfall to enable it to complete its phase i trials of hemo-car-t and will require additional working capital within the next 12 months in order to be able to continue its product development activities, focusing on hemo-car-t. there can be no assurance that either the funding shortfall will be addressed in whole or in part, neither is there an assurance that the group will have access to any financing on terms which are acceptable, or at all, in which case the group's product development activities would have to cease and the company would no longer be adequately capitalised. in those circumstances the directors would have to consider an orderly wind down of the company which may include, in the absence of any other alternative, a liquidation of the company.   to the extent that the company raises additional funds by issuing equity securities, the company's shareholders may experience dilution. any debt financing, if available, may involve restrictive covenants.   at present, and as mentioned above, the company has insufficient working capital for its foreseeable requirements over the 12 months from the date of these interim results. however, the directors believe that the company will be able to access additional financing. the directors, therefore, have made an informed judgment, at the time of approving these financial statements that the company will be able to raise sufficient funds to continue in operation for the foreseeable future. as a result, the directors have continued to adopt the going concern basis of accounting in preparing these interim financial statements.   segmental reporting   the group's operations are located in new york, usa, the parent company is a public company which is administered in the united kingdom. the main assets of the group, cash and cash equivalents, are held primarily in the united kingdom and the united states, while the fixed assets and right of use assets are held in the united states. the board ensures that adequate amounts are transferred internally to allow all companies to carry out their operations on a timely basis.   the group currently has one reportable segment: a biotechnology business focused on the discovery, development and commercialisation of blood diseases such as aml and autoimmune diseases, and certain viral infections.     accounting policies   the accounting policies, presentation and methods of computation applied by the group in these condensed interim financial statements are the same as those applied by the group in its consolidated financial information in its 2024 annual report and accounts, with the exception of the following policies;   equity instruments share warrants issued to third parties for their participation in equity fundraises meet the equity classification under ias 32. such warrants are recognised within equity together with the related share proceeds, and are not subsequently remeasured.   derivative financial instruments derivatives embedded in hybrid contracts with hosts that are not financial assets within the scope of ifrs 9 (e.g. financial liabilities) are treated as separate derivatives when they meet the definition of a derivative, their risks and characteristics are not closely related to those of the host contracts and the host contracts are not measured at fvtpl. if the hybrid contract is a quoted financial liability, instead of separating the embedded derivative, the company generally designates the whole hybrid contract at fvtpl. new and amended accounting standards and interpretations   the new standards, described below, will be adopted by the group when effective, and have had no impact on these half yearly results.   on 12 february 2021 the iasb issued an amendment to ias 1 concerning accounting policy disclosures, and an amendment to ias 8 concerning the definition of accounting estimates. on 7 may 2021 the iasb issued an amendment to ias 12 concerning deferred tax related to assets and liabilities arising from a single transaction. the company does not expect a material impact from the application of these two amendments, which are effective for annual reporting periods beginning on or after 1 january 2024. the company adopted these amendments as required, and the impact was not material.   4.         significant accounting judgements, estimates and assumptions   the preparation of the financial statements in conformity with international financial reporting standards requires the use of certain critical accounting estimates. it also requires management to exercise its judgement in the process of applying the company's accounting policies. actual results may differ from these estimates.   in preparing these condensed interim financial statements, the significant judgements made by management in applying the group's accounting policies and the key sources of estimation uncertainty were the same as those applied to the consolidated financial statements for the year ended 31 december 2024, with the exception of the following;   (a)  valuation of derivative liabilities   in may and june 2025 the company issued a combined total of 500,000 warrants to an investor as part of a fundraise exercise. the warrants are exercisable for a period of 36 months (the "exercise period") were issued with an exercise price of £2.70 (the "exercise price") which is subject to adjustment in certain circumstances, including a reset of the exercise price if the company completes a share issuance (or other transaction granting rights to subscribe for equity securities) during the exercise period at a price lower than the exercise price.   the method of exercise has been deemed to contain derivative elements due to the adjustment feature. as such the directors have designated warrants on inception as a derivative instrument that is fair valued through profit or loss.   the fair value of the warrants at inception and as at the reporting date of 30 june 2025 have been established using the monte carlo valuation method.   5.         earnings per share   basic and fully diluted earnings per share are calculated by dividing the loss for the        six months from continuing operations of £2,949,309 (six months to 30 june 2024: £2,918,086 loss) attributable to equity owners of the group by the weighted average number of ordinary shares in issue during those periods of 3,535,918 and 3,067,252 respectively.   diluted loss per ordinary share equals basic loss per ordinary share as, due to the losses incurred in the six months to 30 june 2025 and six months to 30 june 2024, there is no dilutive effect from the subsisting share options and warrants.   on 9 december 2024 the company undertook a capital restructure. as such, the weighted average number of ordinary shares outstanding as at 30 june 2024 has been adjusted for the proportionate change in the number of ordinary shares outstanding as if the event had occurred at the beginning of the earliest period presented.   6.         property, plant and equipment   during the six months ended 30 june 2025, the group acquired assets with a cost of £3,921 (six months ended 30 june 2024: £nil) and incurred depreciation expense of £113,869 (six months ended 30 june 2024: £116,804).   7.         issued capital   deferred shares ordinary shares  deferred share capital £ called up share capital   £  share premium   £         as at 31 december 2024 1,401,815,988 3,504,540   13,983,115 35,045   21,388,546 issue of shares - 994,000  - 9,940  1,941,761 derivative liability - -  - -  (468,494) conversion of convertible loan notes - 95,000  - 950  284,050 share issuance costs - -  - -  (218,803) as  at 30 june 2025 1,401,815,988 4,593,540  13,983,115 45,935  22,927,060   during the six months ended 30 june 2025, the company issued 994,000 new ordinary shares through subscription agreements and a further 95,000 ordinary shares upon the automatic conversion of convertible loan notes. in connection with these financings, the company also issued warrants (see note 9).   8.         derivative financial instruments   during the six months ended 30 june 2025, the company issued warrants in connection with equity placings completed in may and june 2025. these warrants include reset features that preclude equity classification under ias 32 and have therefore been recognised as derivative financial instruments at fair value through profit or loss.   warrants warrant liability £    as at 31 december 2024 - - issue of warrants 500,000 468,494 change in fair value - 66,552 as  at 30 june 2025 500,000 535,046   at 30 june 2025, 500,000 derivative-classified warrants were outstanding. these include 250,000 warrants issued with the may 2025 placing, exercisable at £1.80 per share and expiring in may 2028, and 250,000 warrants issued with the june 2025 placing, exercisable at £1.80 per share and expiring in june 2028. the warrants are remeasured to fair value at each reporting date, with changes in value recognised within profit or loss.   the following assumptions and inputs were included in the fair value calculation;   stock price £1.53 annual equity volatility 87.8% risk-free rate 3.7% term to maturity 2.85 years discount rate 15%   9.         share-based payments   options   during the six months to 30 june 2025, no options were issued to directors or employees and 15,002 options lapsed during the six months to 30 june 2025.   a schedule of options granted since inception for all plans as at 30 june 2025 is shown below:   number of options members of the scientific advisory board 31,205 employees, including directors 260,817 total 292,022   for the six months ended 30 june 2025, the company did not recognise share-based payment expense in the statement of profit or loss (30 june 2024: £343,134).   warrants   during the six months ended 30 june 2025, the company issued warrants in connection with equity subscriptions, placings, and the conversion of convertible loan notes. these warrants were recognised directly in equity within the warrant reserve.   warrants   as at 31 december 2024 - issue of warrants 247,000 issuance of warrants on conversion of convertible loan notes 95,000 as  at 30 june 2025 342,000   at 30 june 2025, a total of 342,000 warrants were outstanding. these include warrants issued with equity subscriptions, placings, and upon conversion of convertible loan notes during the period. exercise prices range from £3.50 to £5.00 per share and expiry dates range from february 2026 to may 2026.   10.       right of use assets and leases   the group follows ifrs 16 with respect to its leases, whereby the group recognises right-of-use assets and lease liabilities for all leases on its balance sheet. one of the us subsidiaries has an agreement for the lease of laboratory facilities to which ifrs 16 has been applied.   during the six months ended 30 june 2025, the group incurred a right of use asset depreciation expense of £199,914 (six months ended 30 june 2024: £204,881), incurred lease liability interest expense of £119,889 (six months ended 30 june 2024: £141,689 ) and made lease payments in the amount of £345,832 (six months ended 30 june 2024: £369,982 ).               this information is provided by rns, the news service of the london stock exchange. rns is approved by the financial conduct authority to act as a primary information provider in the united kingdom. terms and conditions relating to the use and distribution of this information may apply. for further information, please contact rns@lseg.com or visit www.rns.com.  rns may use your ip address to confirm compliance with the terms and 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Label: Gestiegen