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    Race Oncology_ Historical Overview and Future Outlook.pdf


    Race Oncology: Historical Overview and Future Outlook

    Company News and Key Developments (ASX Announcements and Updates)

    Clinical Trial Progress:Race Oncology’s lead drug, bisantrene (also known as Zantrene or RC220), has undergone extensive clinical evaluation. After positive Phase 2 results in relapsed/refractory acute myeloid leukemia (AML) in Israel (40% response rate reported in 2020)raceoncology.com, Race moved to broaden bisantrene’s use. In late 2023, Race executed anA$8.6 million contract to launch a multi-national Phase 1 trialof RC220 in advanced solid tumorsintelligentinvestor.com.au. Ethics approval for this trial was secured in March 2025intelligentinvestor.com.au, and the first Australian site opened by early April 2025intelligentinvestor.com.au. Patient enrollment proceeded swiftly: asecond site openedin late April 2025intelligentinvestor.com.au, and by 1 May 2025 Race announced it hadsuccessfully and safely dosed its first patientwith RC220company-announcements.copyright linkcompany-announcements.copyright link. This trial is designed to evaluate RC220 both alone andin combination with doxorubicin(a standard chemotherapy) to assess safety, tolerability, and potential cardioprotective effectscompany-announcements.copyright linkcompany-announcements.copyright link. The open-label Phase 1 study will enroll up to 33 patients in Stage 1 (dose escalation) and an additional 20 patients in Stage 2, expanding to sites in Australia, Hong Kong, and South Koreacompany-announcements.copyright linkcompany-announcements.copyright link. Race has committed to providing regular trial updates given the open-label design (while avoiding patient-by-patient disclosures)company-announcements.copyright link. Indeed, the“First Patient Dosed” news was met with a 22% share price jumpon the ASX, underscoring investors’ anticipationintelligentinvestor.com.au.

    Earlier, Race had already reportedencouraging AML clinical outcomesthat set the stage for its current trials. A single-agent Israeli Phase 2 in 2020 showed a 40% overall response, particularly in patients with extramedullary diseaseen.wikipedia.orgen.wikipedia.org. A follow-up combination trial at Israel’s Sheba Medical Center (using bisantrene with fludarabine and clofarabine) reported in late 2023 that6 heavily pre-treated AML patients improved enough to receive bone marrow transplants, withno cardiotoxicity observedfrom the bisantrene-based regimenen.wikipedia.org. These results, presented as an ASH 2023 poster by Danyleskoet al., werepromising for such refractory patientsand reinforced bisantrene’s unique safety profileen.wikipedia.orgen.wikipedia.org.

    Financial and Corporate Developments:Race Oncology’sfinancial reportshave reflected its R&D ramp-up and funding strategy. The company held A$17.1 million in cash as of March 31, 2025intelligentinvestor.com.au, aided by a A$5.25 million R&D tax incentive refund received in late 2024intelligentinvestor.com.au. Regular quarterly cashflow reports and half-year/full-year financial statements have been released on schedule (e.g. Appendix 4C on 31 Jan 2025, Appendix 4D on 25 Feb 2025)intelligentinvestor.com.au, keeping investors apprised of the burn rate and runway. Thus far, Race has largely financed operations through equity (including option exercises) and Australian R&D rebates, with no major debt. Thecapital structuresaw some dilution from option conversions – for instance, applications for new share quotations were filed in Jan–Feb 2025intelligentinvestor.com.au– but also strengthened the cash position. No large placements in 2025 have been publicized, suggesting the company is funded at least through its near-term trial milestones. Investors can likely expect ongoing quarterly 4C cashflow announcements (end of January, April, July, October each year) and annual reports each September, as these are routine and price-sensitive by nature.

    Race has also undergonesignificant management and board changesto position for its next growth phase. Dr.Daniel Tillett– formerly Chief Scientific Officer – was appointed as permanent CEO and Managing Director in November 2023announcements.asx.com.au, after a period as interim CEO. This appointment was part of a broader board renewal: earlier in 2023, long-time CEO Phillip Lynch departed and Executive Chairman Dr. Peter Smith assumed leadership during the transition. The board was strengthened with new biotechnology expertise in late 2024, exemplified by the addition of Dr.Megan Baldwin(former CEO of Opthea) as a non-executive directorintelligentinvestor.com.au. At the same time, some legacy directors stepped down (per the “Board Renewal Update” announced 2 Sept 2024). These changes were well-received; a December 2024 announcement explicitly highlighted that Race “Strengthens Board” by bringing in seasoned drug development professionalsintelligentinvestor.com.au. The leadership overhaul reflects a focus on clinical execution and partnering. Indeed, the CEO and Executive Chair together emphasized at the 2024 AGM that the company is entering a crucial clinical stagecompany-announcements.copyright link. We can expectcontinuity in leadership communications– for example, regular CEO letters or presentations around the AGM each November – to update shareholders on strategy.

    Partnerships and Collaborations:Race Oncology has actively formed collaborations to accelerate development. In July 2023, the company executed aglobal license agreement with City of Hope, a leading US cancer center, securing exclusive rights to City of Hope’s intellectual property around the Fat Mass and Obesity-associated protein (FTO) discoverybiospace.combiospace.com. This IP stems from City of Hope’s breakthrough finding that bisantrene is a potent inhibitor of the FTO m^6A RNA demethylase pathwaybiospace.combiospace.com– an insight that underpins Race’sFTO-directed oncology strategy. The license grants Race freedom to operate and collaborate with City of Hope’s scientists as it explores bisantrene’s FTO-related uses. Around the same period, Race entered anagreement with Ardena(a European contract development and manufacturing organization) to produce drug product under cGMPraceoncology.com. This ensured adequate clinical-grade supply of RC220 for the multi-site trials. Other key partnerships include those with leading research and medical centers: theUniversity of Newcastlein Australia (Assoc. Prof. Nikki Verrills’ lab) for preclinical studies in extramedullary AML and cardioprotectionraceoncology.comraceoncology.com, theSheba Medical Centerin Israel for clinical trials, and theUniversity of Wollongongfor novel analog development (Professor Michael Kelso’s team). Race also reported collaborations with institutions likeMD Anderson Cancer CenterandUniversity of Chicago, who independently explored bisantrene’s FTO inhibition in various modelsen.wikipedia.orgen.wikipedia.org. These partnerships not only validate Race’s science but often lead to publications (discussed below). We anticipate that Race will continue to seek collaborations – for example, additional trial sites in the US or Asia, or a pharma partner for late-stage trials – especially if upcoming data is positive.

    Investor Communications:The company maintains an active outreach to investors. It regularly releasesinvestor presentations and strategy updates(e.g. theMay 2024 Investor Presentationannouncements.raceoncology.comand the AGM presentation in Nov 2024company-announcements.copyright link) to articulate its “Three Pillar” strategy. In these materials, Race reiterates its focus on (1)FTO-driven cancers(leveraging the City of Hope discovery), (2)extramedullary AML and other hard-to-treat cancerswhere Zantrene has shown efficacy, and (3)cardioprotection in oncology(using Zantrene to make traditional chemo safer)openbriefing.comopenbriefing.com. For example, an ASX strategic update in September 2023 outlined preclinical data thatZantrene synergizes with anthracyclines(doxorubicin) in 85% of tested cancer cell lines, supporting the cardioprotection pillarcompany-announcements.copyright linkcompany-announcements.copyright link. Race’s leadership often presents at biotech conferences and investor forums – in July 2025 the company will present at the TechKnow Invest Roadshowhotcopper.com.au– which suggests a steady flow of news in line with such events. Media coverage has also grown: outlets likeThe Australianand*have highlighted milestones such as the first patient dosing and the “heart-safe” chemo approachraceoncology.comraceoncology.com. These channels amplify Race’s message and will likely broadcast any major breakthroughs in 2025–2026.

    Scientific Publications on Bisantrene (Key Papers and Findings)

    Bisantrene has a rich bibliography spanning its initial development and recent “rediscovery.” Race Oncology and independent researchers have published several noteworthy papers:

    • 2017 – “The Rediscovery of Bisantrene” (Rothman,Int. J. Cancer Research & Therapy):A comprehensive review of bisantrene’s history and pharmacology, authored by Race’s then-CSO Dr. John Rothmanopenbriefing.com. Published in July 2017, this peer-reviewed article summarized over 60 prior clinical trials and highlighted bisantrene’s efficacy across leukemias, lymphomas, breast and ovarian cancers, withnotably reduced cardiotoxicitycompared to anthracyclinesopenbriefing.comopenbriefing.com. It underscored that bisantrene had been “lost” due to 1990s corporate mergers despite anapproval in France in 1991 for AMLopenbriefing.com, and called for renewed clinical development – essentially laying the groundwork for Race’s missionopenbriefing.comopenbriefing.com.

    • 2020 – City of Hope FTO Discovery (Suet al.,Cancer Cell):In June 2020, a breakthrough paper inCancer Cellrevealed that bisantrene is apotent and selective inhibitor of FTO, a protein implicated in cancer via RNA methylation dysregulationcancer.gov. In this study, City of Hope researchers screened 260,000 compounds and found bisantrene (codenamed “CS1”) to be one of the most effective FTO blockerscancer.govcancer.gov.In AML mouse models, bisantrene slowed leukemia growth and eradicated leukemia stem cellswhile boosting immune attackcancer.gov. This discovery – published by Rui Su and colleagues – explained a new mechanism of action for bisantrene and catalyzed Race’s strategic pivot to FTO-driven cancers. (Notably, the paper’s supplementary discussion explicitly confirmed“CS1” was bisantreneen.wikipedia.orgen.wikipedia.org, a fact Race promptly leveraged.) This highly cited work positioned bisantrene as a novel epigenetic cancer therapy and was partlyfunded by the NCI, reflecting its scientific importancecancer.gov.

    • 2021 – Independent FTO Studies:Following the Cancer Cell report, academic interest in bisantrene surged. Researchers at the University of Chicago demonstrated inNature Communications (2021)that using bisantrene (“CS1”) to inhibit FTO could suppress tumor growth in certain contextsen.wikipedia.org. Similarly, a French team at University of Lille published inCells (Jan 2022)that bisantrene’s FTO inhibition might even have implications beyond oncology – they tested it in cellular models ofdiabetes-related metabolic dysregulationen.wikipedia.orgen.wikipedia.org. These studies, while outside Race’s core focus, reinforced bisantrene’s role as a powerful tool for probing the m^6A RNA pathway.

    • 2022 – Combination Therapy Synergy (Valdezet al.,Leukemia & Lymphoma):A team at MD Anderson Cancer Center (University of Texas) explored bisantrene in modern combination regimens. TheirJuly 2022paper reported“enhanced cytotoxicity of bisantrene when combined with venetoclax, panobinostat, decitabine, and olaparib”in AML cell linesen.wikipedia.org. Bisantrene showed synergistic killing of leukemia cells alongside these targeted agents, and notably retained itslow-cardiotoxic profileas a topoisomerase II inhibitortandfonline.compubmed.ncbi.nlm.nih.gov. This peer-reviewed study supports Race’s approach of using Zantrene in combination therapies for AML (e.g. with hypomethylating agent decitabine or the BCL-2 inhibitor venetoclax). It also validates the idea that bisantrene could be less harsh on the heart than standard anthracyclines even in potent drug cocktailstandfonline.com.

    • 2023 – AML Trial Results and Preclinical Advances:In late 2023, two high-profile publications showcased new data on bisantrene:

      • Clinical:Investigators from Sheba Medical Center presented thePhase 1/2 trial results of bisantrene + fludarabine + clofarabine in R/R AMLat the ASH 2023 conference (I. Danyleskoet al.). As noted, the poster (published inBlood2023, vol. 142, S1, abstr. 5773) reported multiple patients bridged to transplant and no cardiac toxicityen.wikipedia.orgen.wikipedia.org. This suggests bisantrene can be combined with intensive regimens safely, even in frail patients – a significant clinical finding that Race may leverage when designing future AML trials.

      • Preclinical:A joint study by University of Newcastle and Race scientists led by Dr. Nicole Verrills waspublished inBlood(Nov 2023), demonstrating thatbisantrene is synergistic with decitabine in AML modelsen.wikipedia.org. This work (“Preclinical Evaluation of Bisantrene as Single Agent and in Combination with Decitabine for AML”) provided the scientific rationale for combining Zantrene with hypomethylating agents in AMLen.wikipedia.org. The authors recommended that this combination move into clinical testingen.wikipedia.orgen.wikipedia.org, aligning with Race’s planned extramedullary AML trial. The publication in a top hematology journal validates Race’s preclinical program and was timed alongside the ASH conference, maximizing its visibility.

    • Cardioprotection Research:A unique aspect of bisantrene is its heart-sparing property. Race initiated apreclinical cardiotoxicity studyin 2021 to investigatewhyZantrene is less cardiotoxicaspecthuntley.com.au. Interim results announced in 2022 showedbisantrene can protect heart muscle cells and mice from anthracycline damage while preserving anticancer activityraceoncology.comraceoncology.com. This work, led by Dr. Doan Ngo in collaboration with Race, earned recognition for its “game-changing” implicationsen.wikipedia.orgen.wikipedia.org. The collaboration was later expanded to delve deeper into molecular mechanisms (e.g. effects on mRNA methylation in cardiomyocytes)listcorp.com. We anticipate that final results from these heart safety studies will be published, potentially in 2025. In fact, an academic review in early 2024 already cited thatbisantrene can directly protect cardiomyocyteswhile treating cancer**promotion blocked**.com.au. Such data will be crucial as Race positions Zantrene as a cardio-protective adjunct to chemotherapy.

    In summary, Race has actively disseminated its findings through reputable journals and conferences. These publications not onlybolster the scientific credibility of Zantrenebut often precede or coincide with Race’s own ASX announcements (ensuring the market is informed of material results). For the 2025–2026 period, we expect further papers on: the outcomes of the Phase 1 solid tumor trial (if successful, likely reported at a conference like ASCO or ESMO), the full analysis of the Israeli AML combo trial in a journal, and mechanistic studies (for example, how Zantrene inhibits FTO or prevents heart cell death at the molecular level). Race’s strategy of peer-reviewed publication provides transparency and can drive investor interest when breakthroughs occur.

    HotCopper Forum Insights and Community Sentiment

    Race Oncology maintains a notable presence on theHotCopperinvestor forum (Australia’s largest stock discussion site), which offers a window into shareholder sentiment and occasional guidance from management. The official company account (username“RaceOncology”) and CEO Dr. Daniel Tillett (posting under the handle“Davisite”) frequently engage with the HotCopper community. They use the forum to clarify announcements, answer investor questions, and manage expectations, all in a public but informal setting. This has cultivated a dedicated shareholder base that is both well-informed and highly anticipative of future milestones.

    Notably,Dr. Tillett’s posts on HotCopper often provide context and hints at Race’s plans.For example, in late 2023 he emphasized the upcoming“series of new trials” in H2 2024 for solid tumoursas a major expansion of Race’s clinical programraceoncology.com. This comment, aligning with formal press interviews and releases, signaled to investors that multiple studies (e.g. the RC220 solid tumor Phase 1 and potentially additional combination trials) were on the near-term horizon. Such communication on HotCopper helped set realistic timelines – in this case, prepping holders that patient recruitment would start by early 2025 (a target Race met). When the first patient was dosed in May 2025, Dr. Tillett promptly engaged on HotCopper, expressing confidence in the trial and thanking long-term shareholders for their supportcompany-announcements.copyright linkcompany-announcements.copyright link. These direct notes reinforce management’s transparency and commitment.

    TheHotCopper community sentiment toward Race Oncology is broadly optimistic, with a strong retail shareholder following. Contributors often reference the “three-pillar strategy” and the scientific merits of Zantrene, indicating a high level of due diligence. One detailed due-diligence post (shared via Reddit) exemplified the prevailing view: it argued that RAC was undervalued relative to its cancer therapy peers, noting a tightly held stock with many long-term holders, and predicting the market cap could multiply (to near $1 billion) if key milestones were hitreddit.com.Community expectationsare indeed high – there is open speculation about a potentialbuyout or big-pharma partnership in the next 12–24 monthsreddit.com, contingent on successful trial outcomes. While such forward-looking optimism is common on stock forums, Race’s management has carefully encouraged a long-term outlook. Dr. Tillett, in forum discussions, often downplays short-term price fluctuations and reiterates that execution of trials and data generation are the company’s top priorities (implicitly validating the long-horizon approach of many shareholders).

    Another theme on HotCopper isenthusiasm for the FTO-targeted approach and cardioprotection angle. Users @RaceOncology (company rep) have shared media articles and conference updates – for instance, highlighting news pieces calling Race “the ASX stock winning the race to make cancer care heart-safe”raceoncology.comraceoncology.com– which bolsters morale on the forum. Investors frequently discuss upcoming catalysts, such as: interim trial results, scientific conference presentations, and regulatory submissions. The tone of discussions suggests that the community is eagerly scanning for hints. Indeed, when Race received ethics approval for the Phase 1 trial in March 2025, forum members quickly extrapolated a timeline for first dosing, which proved accurate within weeks.Davisite’s occasional cryptic hints(always within what ASX rules allow) often set these discussions alight – for example, he hinted that 2025 would be “even more significant” than prior years, given multiple trials running concurrently and data readouts due.

    It’s worth noting that while sentiment is bullish, there is also a measured understanding of risks on the forum. Some veteran participants temper the excitement by pointing out typical biotech challenges (trial delays, funding needs, regulatory hurdles). However, the overall HotCopper narrative is that Race Oncology is at a crucial inflection point (transitioning from purely preclinical/Phase 2 intoPhase 1/2 trials in broader indications), and that success could materially re-rate the company’s value. The presence of management in these discussions lends credibility – shareholders feel “in the loop,” which can reduce speculative misinformation. Going forward, we expect HotCopper to remain a central platform for Race’s retail investors:any ASX announcement immediately spawns detailed threadsdissecting the news, often with hundreds of comments within hours. For instance, the announcement of newsenior clinical team appointments in May 2025drew dozens of comments discussing how the hires might expedite trial recruitmenthotcopper.com.auhotcopper.com.au. As 2025–2026 unfolds, watch for HotCopper threads titled with “Ann:” followed by the news headline – these will contain not only investor reactions but sometimes clarifications from Dr. Tillett or the company’s IR, providing valuable insight beyond the press release. In summary,the HotCopper community serves as both a barometer of shareholder sentiment and a conduit for informal guidance, which collectively indicate strong confidence in Race’s trajectory tempered by an acute awareness of key milestones to come.

    Outlook and Predictive Timeline for 2025–2026

    Building on the above sources, we can project a timeline of anticipatedpublic announcements, scientific releases, and price-sensitive eventsfor Race Oncology over the next two years. These projections consider the company’s typical news cadence, stated plans, and historical patterns:

    • Q3 2025: Initial Phase 1 Trial Progress Updates– By mid-to-late 2025, Race is likely to announce interim safety findings from the ongoing RC220 Phase 1 solid tumor trial. Given the open-label design, the company indicated it would provideregular updates on the trial’s progresscompany-announcements.copyright link. We expect an announcement when the dose-escalation reaches the combination stage with doxorubicin (i.e. once a safe monotherapy dose is established). This could come in Q3 2025, for example,“RC220 Trial Progresses to Doxorubicin Combination Dosing”, detailing that multiple patients have been treated with no dose-limiting toxicities observed. Such an update would be price-sensitive as it marks de-risking of the cardioprotection hypothesis in humans. It might be timed around a major oncology conference or investor event in H2 2025.

    • Late 2025: Annual R&D Tax Incentive and Financials– Consistently, around Oct–Nov each year, Race announces receipt of the Australian R&D tax rebate (A$4–5M in recent years)raceoncology.com. We anticipate alate 2025 announcement of the FY2025 R&D rebate, which bolsters the cash position. Coupled with this, theAnnual Report for FY2025will likely be released in September 2025, summarizing the year’s progress. Given 2025 will encompass major trial milestones, the annual report (and accompanying CEO/Chair’s letter) should provide guidance for 2026. AnAGM in Nov 2025will also be newsworthy; investors expect updates on strategy (perhaps expansion plans for Phase 2 trials or partnering efforts) during the AGM presentationcompany-announcements.copyright link.

    • Late 2025: Scientific Conference Presentations– By the end of 2025, Race may have early data suitable for a scientific conference. For instance, if the extramedullary AML Phase 1/2 trial (the Israeli study) final results are ready, these could be presented at theAmerican Society of Hematology (ASH) 2025meeting (Dec 2025). Race would publicize this via ASX if an abstract is accepted, similar to how it highlighted the 2023 ASH posteren.wikipedia.org. Additionally, anyinitial signals of cardioprotectionfrom the Phase 1 solid tumor trial (e.g. cardiac biomarker data) might be shared at a cardiology-oncology forum or oncology conference. Expect news like“Race to Present Phase 1 Findings at [Conference]”in late 2025, which would be market-sensitive as it disseminates efficacy/safety glimpses.

    • Q1 2026: Phase 1 Trial Completion (Stage 1)– Based on current recruitment targets, the dose-escalation Stage 1 of the RC220 trial (up to 33 patients) could complete by early 2026. We project anASX announcement in H1 2026 declaring the completion of Stage 1and the recommended Phase 2 dose (or maximum tolerated dose) of RC220 in combination with doxorubicin. This would likely be phrased as“Phase 1 Trial Meets Primary Endpoints – Zantrene Safe in Combination with Doxorubicin”, reporting that cardiotoxicity remains low and outlining the plan to proceed to Stage 2 expansioncompany-announcements.copyright linkcompany-announcements.copyright link. Such news would be a major inflection point for the company, confirming proof-of-concept for the heart-protective chemo regimen. It may coincide withopening trial sites in Hong Kong/South Koreaif not already active, which would also be announced when those international approvals come through (possibly in late 2025 or early 2026).

    • Mid 2026: Initiation of Phase 2 Trials– If Phase 1 data are positive, Race could launch Phase 2 trials in 2026. Potentially, aPhase 2b trial in AMLcould be announced, leveraging the successful outcomes from the Israel study and UoN preclinical work. For example, Race might pursue a registration-directed trial of Zantrene + decitabine in relapsed AML (given the synergy shownen.wikipedia.org). An announcement like“Race Oncology to Commence Phase 2 Trial in AML”might come by mid-2026, outlining design and expected start dates. Similarly, aPhase 2 trial in breast cancer or sarcomas(cancers where anthracyclines are standard and heart toxicity is a concern) could emerge as Pillar 3 (cardioprotection) moves forward. Anypartnership with a larger pharmafor these trials would be immensely price-sensitive – e.g. if Race partners to test Zantrene alongside an established chemo in breast cancer, expect a standalone announcement.

    • Mid/Late 2026: Peer-Reviewed Publications– As the trials progress, Race will continue to publish outcomes. We anticipate by late 2026, thefull results of the Phase 1 solid tumor trial(Stages 1 and 2) will be submitted to a journal or at least presented at a conference. An ASX announcement would accompany a publication, something like“Phase 1 Results Published in [Journal Name] – Confirms Zantrene’s Safety and Efficacy”. Additionally, any novel findings from thecardioprotection mechanism studyare likely to be published around 2025–2026. For example, if Dr. Ngo’s team identifies the molecular pathway by which Zantrene spares heart cells, that could appear in a journal likeCirculationorJACC: CardioOncology. Race would issue a press release highlighting“Mechanism of Zantrene’s Heart Safety Uncovered”, which could elevate the drug’s profile**promotion blocked**.com.au.

    • Ongoing (2025–2026): Routine Catalysts– Throughout 2025 and 2026, Race will continue to issue its routine quarterly reports (Appendix 4C cashflow and activity statements). These often contain qualitative updates. For instance, the March 2025 quarterly report confirmed that“Patient enrolment for the Phase 1 trial…is now open”and first dosing was imminentintelligentinvestor.com.auintelligentinvestor.com.au. Future quarterlies will likely include status updates such as“X patients dosed to date in Phase 1”or“preparations underway for Phase 2”. Investors should watch theApril 2026 and July 2026 quarterliesin particular – by then, substantial progress will warrant detailed commentary. Another area of focus isintellectual property: Race has filed patents (e.g. on the method of cardioprotectionpatents.google.com). Any patent grants in key jurisdictions or new patent filings (perhaps covering second-generation FTO inhibitors or combination uses) would be announced promptly, as they strengthen Race’s moat. Lastly,leadership or governance changescannot be ruled out – for example, if the company were to attract a high-profile oncology executive or if a board member from a pharma partner joins the board, those would be material updates.

    The following table summarizes the expected key events and our estimated timing:

    Expected TimingAnticipated EventDetails & Significance
    Q3 2025Interim Phase 1 Results – Dose EscalationAnnouncement that RC220 Phase 1 (solid tumors) safely reached combo dosing with doxorubicincompany-announcements.copyright linkcompany-announcements.copyright link. Confirms no serious cardiotoxicity; enables proceeding to full dosing. Likely aligned with a conference update.
    Late 2025FY2025 R&D Rebate & Annual ReportReceipt of ~$5M R&D tax refund for FY25raceoncology.comreported (boosts cash). Annual Report and AGM update highlight trial progress and 2026 plans. Expect reiteration of multi-trial strategy and possibly guidance on Phase 2 timing.
    Dec 2025Scientific Presentation (ASH 2025)Potential presentation of final AML combo trial dataen.wikipedia.orgor initial RC220 trial data at ASH. Would be accompanied by an ASX notice. Confirms efficacy signals in AML or other cancers to the scientific community.
    Q1 2026Completion of Phase 1 (Stage 1) & Next-Step AnnouncementData from first ~30 patients of Phase 1 solid tumor trial announced. Likely defines maximum tolerated dose and reports safety/pharmacokinetic endpointscompany-announcements.copyright link. Race will announce plans for Stage 2 expansion (additional patients) or moving directly into Phase 2. Major de-risking milestone for Zantrene’s platform.
    Mid 2026Initiation of Phase 2 TrialsAnnouncement of new clinical trials (Phase 2). Possibilities: a Phase 2 in AML (e.g. Zantrene + decitabine) leveraging 2023–24 dataen.wikipedia.org; or a cardio-protection trial in breast cancer (Zantrene + doxorubicin vs doxorubicin alone to compare heart outcomes). Any such trial start would be material, and could involve a partner or grant.
    Late 2026Key Publications and Data ReadoutsPublication of Phase 1 trial results in a peer-reviewed journal or presentation at ESMO/ASCO 2026. Also, final results from preclinical heart safety studies expected – possibly yielding a high-impact publication on Zantrene’s cardioprotective mechanism. Race will issue ASX releases for each significant paperen.wikipedia.org**promotion blocked**.com.au, enhancing credibility ahead of Phase 2.
    Ongoing 2025–2026Quarterly Reports & Other UpdatesContinual flow of info: quarterly cash reports (with operational updates), half-yearly financials (Feb each year), AGM presentations (Nov each year). Also ad-hoc news: new patents, manufacturing scale-ups, regulatory designations (e.g. an FDA Orphan or Fast Track for an indication) if pursued. Anynotable personnel additionsorstrategic partnerships/licensing dealswould be immediately announced and could occur anytime – these are difficult to time, but management’s forum comments hint that they remain open to collaboration at the right moment.

    Each of these anticipated events is drawn from the momentum Race has built through 2024 into 2025. Of course,exact timelines depend on trial recruitment and data outcomes– delays are possible (for instance, if enrollment is slower, the Phase 1 completion might slide to H2 2026). Conversely,positive surprises(such as exceptionally good efficacy in an interim analysis) could accelerate partnership talks or regulatory interactions (e.g. Race might engage the FDA in 2026 for guidance on an accelerated approval path in AML). The company’s proactive communications so far – via ASX releases, scientific conferences, and even CEO interactions on HotCopper – suggest that investors will not be left in the dark. Stakeholders can expect Race to promptly announceprice-sensitive developmentssuch as major clinical milestones or deals, consistent with ASX disclosure rules.

    In summary, the next two years for Race Oncology are set to be catalyst-rich. The groundwork laid by past announcements, scientific research, and community engagement points to a period where Race will transition from early-phase trials toward more advanced development. Investors and followers of the company should monitor the scheduled announcements (quarterly results, AGM, etc.) and be prepared for unscheduled but significant news (trial breakthroughs or partnerships). With a clear roadmap and transparent communication, Race Oncology is positioning itself to deliver potentially transformative news in 2025 and 2026 – news that could firmly establish its place “at the heart of cancer care,” as its mission suggests.raceoncology.com


 
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