10-Q

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 7, 2024, there were 331,206,012 ordinary shares, nominal value £0.0025 per share, outstanding, which if all were held in ADS form would be represented by 165,603,006 American Depositary Shares, each representing two ordinary shares.

2024年9月30日終了の3か月のためのこの四半期報告書（この「四半期報告書」）は、1933年証券法の27A条、改正された（「証券法」）、1934年証券取引法の21E条、改正された（「取引所法」）、および1995年私的証券訴訟改革法の意味での前向きな声明を含んでいます。場合によっては、「may」、「might」、「will」、「could」、「would」、「should」、「goal」、「target」、「expect」、「intend」、「plan」、「objective」、「anticipate」、「believe」、「estimate」、「predict」、「potential」、「continue」、「ongoing」といった言葉や、これらの用語の否定形、または未来についての声明を特定することを意図した他の類似の用語によって、前向きな声明を特定できます。これらの声明は、私たちの実際の結果、活動レベル、パフォーマンスまたは成果が、これらの前向きな声明によって表現されたまたは暗示された情報と重要に異なる可能性のある既知および未知のリスク、不確実性、その他の重要な要因を伴います。この四半期報告書に含まれる前向きな声明、予測および意見は、この四半期報告書の日付時点で私たちが利用可能とした情報に基づいており、そのような情報がそのような声明の合理的な基盤を形成していると私たちは信じているものの、その情報は限定的または不完全であり、すべての潜在的に利用可能な関連情報について、私たちが包括的な調査やレビューを行ったことを示唆してはならないと私たちの声明は解釈されるべきではありません。前向きな声明には、以下のような声明が含まれます:

「Part I, Item 1A. リスクファクター」と題された箇所を参照してください。会社の年次報告書（フォーム10-k）で、2024年6月30日の年末に終了する年に含まれているもの、およびこの四半期報告書内の「財務状態および業績に関する経営陣の議論と分析」と「リスクファクター」のセクションには、当社の実際の結果が当社の将来の展望によって明示または黙示されるものと大きく異なる要因に関する議論が記載されています。これらの要因の影響により、当四半期報告書内の前向きの記述が正確であるとは保証できません。さらに、当社の前向きの記述が不正確であることが判明した場合、その不正確性は重大なものである可能性があります。これらの前向きの声明における重大な不確実性を考慮すると、当社またはその他の当事者が指定時期内またはすべての時期において目標や計画を達成することを表明または保証しているとは見なすべきではありません。前向きの声明は、そのような声明がなされた日にのみ有効です。当社は、法律、適用規制、またはOTCQb市場の規則に従う限り、新しい情報、将来のイベント、またはその他の理由により前向きな声明を公に更新する義務を負いません。

全セクターを完全に理解して、この四半期報告書、この四半期報告書で参照している文書、および当社がこの四半期報告書に添付した文書を読むべきであり、実際の将来の結果は私たちの予想と大きく異なる可能性があることを理解してください。当社の将来を見据えたすべての発言は、これらの警告的な声明によって条件付けられます。

付随する注記は、これらの統合された財務諸表の重要な部分です。

1. Business and risks

Renalytix plc and its wholly-owned subsidiaries, the “Company” or "Renalytix," is an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and significantly lower healthcare costs. KidneyIntelX, the Company’s first-in-class diagnostic technology platform, employs a proprietary artificial intelligence-enabled algorithm that combines diverse data inputs, including validated blood-based biomarkers, inherited genetics and personalized patient data from EHR systems, to generate a unique patient risk score. kidneyintelX.dkd is the Company’s FDA approved, Medicare reimbursed prognostic testing service currently implemented with large physician group practices, health care systems in the United States.

The Company is also collaborating with pharmaceutical companies which generates ‘Pharmaceutical Services Revenue’ using KidneyIntelX platform technology for understanding patient response to novel and widely used drug therapies including SLGT2 inhibitors and GLP1s

Since inception in March 2018, the Company has focused primarily on organizing and staffing the Company, raising capital, developing the KidneyIntelX technology platform, conducting clinical validation studies, clinical utility studies, health economics studies, establishing and protecting its intellectual property portfolio and commercial laboratory operations, pursuing state and federal regulatory approvals and securing insurance pricing, coverage and payment for its prognostic services. The Company has funded its operations primarily through equity and debt financings. In 2024, following FDA approval, Medicare insurance coverage and guidelines inclusion for kidneyintelX.dkd, the Company largely completed reorganization from development activities to commercial sales activities. This reorganization has resulted in a substantially lower cost of operations and a growing doctor prescription rate of kidneyintelX.dkd.

The Company is subject to risks and uncertainties common to early-stage companies in the diagnostics industry, including, but not limited to, ability to secure additional capital to fund operations, compliance with governmental regulations, development by competitors of new technological innovations, dependence on key personnel and protection of proprietary technology. To achieve widespread usage, kidneyintelX.dkd will require significant investment in sales and marketing. Additional diagnostic services currently under development, if they are pursued at a future date by the Company, will likely require extensive clinical testing and validation prior to regulatory approval and commercialization, and will require various levels of investment capital.

2. 流動性および存続性

当社は設立以来、継続的な損失と運営からの否定的なキャッシュフローを被っており、2024年9月30日時点での累積赤字は$216.5 百万です。当社は、KidneyIntelX.dkdまたはKidneyIntelX テクノロジーサービスの収益を生成できる時期、もしあれば、追加の損失を被ることを予想しています。

期間終了後、当社は約$14.9 百万の株式資金調達ラウンドを費用を差し引いた後で完了し、コスト削減の達成とテストサービスの売上増加と同時に、経営陣はこの資金調達が今後2年間で当社を利益のある運営へと導く可能性が高いと信じています。

当社が継続企業として存続する能力は、今後24ヶ月内に管理が意図した計画を成功裏に実行することに依存しています。これには、制限なしに、

•

ラボでの特定のテストボリュームの達成が含まれます；

•

商業保険者との返済ポリシーと契約の継続的な拡大;

•

運営費と商業費の継続的な管理。

会社の損失と会計文献に定義された予想されるキャッシュニーズの結果、会社の継続性について重大な疑念が存在しています。2024年9月30日の後、会社は約$14.9百万、費用を差し引いた新たな株式資本を調達し、バランスシートに記録されている既存の長期負債を再構築したものの、会社は運営上の損失の歴史があり、kidneyintelX.dkdテストを商業化するためにすべてのマイルストーンを提供するのが高額でした。もし会社が追加の資本を必要とする場合、受け入れ可能な条件で利用できないか、全く利用できない可能性があり、会社が戦略的提携やその他の契約を有利な条件で結ぶことができないこともあります。将来の融資の条件は、会社の株主の保有や権利に悪影響を及ぼす可能性があります。もし必要があれば、会社が資金調達を取得できなければ、研究開発プログラム、製品ポートフォリオの拡大、または将来の商業化努力を延期、縮小、または中止する必要が生じる可能性があり、これがビジネスの展望に悪影響を及ぼす可能性があります。そのため、

3. 発表の基礎および主な会計方針の要約

連結された財務諸表は、合衆国で一般的に受け入れられている会計原則（「米国GAAP」）に準拠して作成されています。これらの注釈における適用可能なガイダンスへの言及は、財務会計基準委員会（FASB）の会計基準コーディケーション（「ASC」）や会計基準の最新情報（「ASU」）に掲載されている米国GAAPを指すものとします。したがって、これらの財務諸表には、年次財務諸表に必要なすべての情報と注釈が含まれていません。これらの財務諸表は、2024年6月30日に終了する当社の10-K年次報告書に記載されている監査済の連結財務諸表および関連する注釈とともに読まれるべきです。本報告書に含まれる2024年6月30日時点の当社の簡略連結貸借対照表の情報は、当社の10-K年次報告書に記載されている監査済の連結財務諸表から引き出されました。
経営陣の見解では、未監査の簡略連結財務諸表には、提示された期間のバランスと結果の公正な記載に必要な通常の繰り返し調整を含むすべての調整が反映されています。2024年9月30日までの3カ月間における業績は、2025年6月30日に終了する通年の業績を必ずしも示すものではありません。

当社と子会社の財務諸表が連結された簡略化された連結財務諸表に含まれています。当社と子会社間のすべての重要な取引は、統合に際して除去されています。

連結財務諸表には、Renalytix plcおよびその完全子会社の取引が含まれています。企業間の残高および取引は、連結の際に除去されています。会社は、支配力は持たないが重要な影響力を持つ投資については、持分法を用いて会計処理を行っています。

米国一般に受け入れられている会計原則（「米国GAAP」）に従う簡易連結財務諸表の作成には、管理陣が報告された金額およびイベントに影響を与える財務情報および関連する注記開示に基づいて、収益年の収益を見積もる必要があります。これらの見積りは、現在の経済環境を含む適切な見解に基づいており、正確であると信じられていますが、一部の見積りには不確実性が伴う可能性があります。実際の結果は、これらの見積もりと異なる場合があります。主要な見積もりと仮定は、無形資産の有用寿命、無形資産と資本金の評価、および所得税に関するものです。

米国GAAPに準拠した連結財務諸表の作成には、経営陣が資産および負債の報告額や財務諸表の日付における潜在的資産および負債、さらには報告期間中の経費額に影響を及ぼす見積りや仮定を行う必要があります。実際の結果は、これらの見積もりから異なる可能性があります。連結財務諸表の作成において使用される見積もりや判断に関連する要因の不確実性のため、実際の結果はこれらの見積もりと大きく異なる可能性があります。

見積もりと仮定は定期的に見直され、修正の影響は必要と判断された時期に一般に財務諸表に反映されます。経営陣の見積もりを要する重要な領域には、株式報酬の公正価値を決定する際に使用される仮定、債券の公正価値を決定する際に使用される仮定、第三者が会社のために実施する研究開発活動のための前払い/アククル、関連費用を記録する際に使用される仮定、固定資産および資本化ソフトウェアの有用寿命を決定する際に使用される仮定が含まれます。

セグメント情報

会社は業績評価と運営上の意思決定を目的として、単一の業績セグメントとして事業を管理しています。会社の単一の焦点は、腎臓疾患の診断と予後、臨床ケア、薬物臨床試験のための患者分類、薬物ターゲットの発見に大幅な改善をもたらすことです。

外貨翻訳

会社の連結財務諸表はアメリカドルで表示されており、それが会社の報告通貨です。Renalytix plcおよびRenalytix AI Limitedの機能通貨はイギリスポンドです。Renalytix AI, Inc.の機能通貨はアメリカドルです。Renalytix plcおよびRenalytix AI Limitedの資産および負債は期末の為替レートで換算され、一方、連結損益計算書および包括損益計算書は報告期間中に有効な加重平均為替レートで換算されます。これらの翻訳調整の純効果は、その他包括損失の構成要素として示されます。機能通貨以外の通貨で表される取引に起因する為替レートの変動による取引損益は、変更が発生した期間の所得に含まれ、連結損益計算書および包括損益計算書に報告されます。

クレジットリスクの集中度と主要顧客

会社がクレジットリスクの集中度にさらされる可能性のある金融商品は、主に現金、現金同等物および売掛金残高です。定期的に、会社は信頼できる金融機関に預金を保管しています。

連邦保険の限度額。この会社は、信頼性が高く、商業銀行関係に伴う通常の信用リスクを超える異常な信用リスクにさらされていないと信じるファイナンシャルインスティテューションズに現金及び現金同等物を預けており、そのような口座で損失を経験したことはありません。

この会社の試験サービスに関連する売掛金は、米国に所在する顧客から得られた売上高に基づいています。2024年9月30日までの3か月間について、約 74%の全ての売掛金は、kidneyintelX.dkdおよびKidneyIntelXテクノロジー試験サービスに関連しており、2名の顧客に関連しています。また、残りの 26%の売掛金はその他の第三者からの支払いによるものでした。 2023年9月30日までの3か月間について、このバランスを内で認識することが予想されます。77%の全ての売掛金は、kidneyintelX.dkd試験サービスの売上高に関連しており、1名の顧客に関連しています。また、約 23%の売掛金はその他の支払い者から発生しました。会社は顧客の初回および継続的な信用審査を行い、顧客の支払能力を評価するために、顧客の財務情報、所在地、その他の要因を考慮しています。また、$の売掛金に対して準備をしています。0.04 2024年9月30日時点での売掛金は百万ドルです。

金融機関の公正価値

2024年9月30日と2024年6月30日時点で、会社の金融商品には売掛金と買掛金が含まれています。これらの資産および負債の帳簿価格は短期性により公正価値に近いです。転換社債は、推定公正価値で記録されています。

公正価値オプション

ASCサブトピック825-10の公正価値オプションのサブセクションに基づき、金融商品 - 全体, 会社は大部分の金融資産と金融負債を公正価値で報告する権利を irrevocable に持っており、これは各金融商品ごとに行われ、公正価値の変動は利益に報告されます（注5参照）。会社は転換社債を推定された公正価値で測定し記録することを選択しました。

現金及び現金同等物

会社は、発行された日から90日以内の短期流動資産として購入された全ての流動性の高い投資を現金同等物と見なします。2024年9月30日及び2024年6月30日の時点で、会社は現金及び現金同等物を$0.9 百万ドル及び$4.7百万株、それぞれ。

売掛金

売掛金は請求書の金額で記録され、無利息です。会社は契約上の支払い条件に基づいて過期の債権を考慮します。会社は回収可能性が合理的に保証されなくなった場合、特定の債権を留保します。信用損失の見積もりは、既存の契約義務、過去の支払いパターン、および個々の顧客の状況に基づいて決定されます。会社は$0.04 百万円の債権を留保しました。 2024年9月30日. 会社は$の債権を予約しました0.1 百万の債権がとして 2024年6月30日.

資産と設備

不動産及び設備は原価で記録されています。減価償却は、推定耐用年数が3年から10年の範囲にわたって定率法を使用して決定されます。維持及び修理の支出は発生時に費用として計上され、更新及び改善は資本化されます。不動産及び設備が売却またはその他の方法で処分されると、原価及び関連する累積減価償却が帳簿から除去され、その結果生じる利益または損失は業務に反映されます。

投資

VericiDx plc

会社は、ASC 321 に従って VericiDx の証券の所有を公正価値で報告しています。、投資-株式証券、ロンドン取引所を通じて VericiDx の普通株式の公正価値が容易に決定できるため、公正価値の変動は収益に記録されます。VericiDx の終値に基づくと、VericiDx への投資の公正価値は $0.8 百万ドル及び$0.7 には100万ドルが含まれていました。 2024年9月30日および2024年6月30日、それぞれです。2024年9月30日および2023年の3か月間にわたり、会社は公正価値の増加を記録しました $0.1 百万および公正価値の減少を記録しました $0.5 百万、それぞれ、連結損益計算書および包括的損失において。2024年9月30日までの三ヶ月間に、会社は$0.042 百万の売却による実現損失を記録しました 250,000 連結損益計算書および包括的損失のその他の費用項目で、VericiDx株の 3.5%の普通株式を2024年9月30日現在、VericiDxの保有していました。

減損評価です

当社は、四半期ごとに、未実現損失ポジションへの投資（ある場合）と、一時的減損以外の持分法投資を評価しています（注記5を参照）。このような評価には、一般的な経済状況や特定の発行体や投資先に影響を与える個別の状況に関連するリスクや不確実性の評価など、さまざまな考慮事項が含まれます。当社が考慮する要素には、（i）投資の公正価値がその費用を下回っていた期間と程度、（ii）発行体の財政状態、信用力、および短期的な見通し、（iii）満期までの期間、（iv）将来の経済状況と市場予測、（v）十分な期間投資を維持する会社の意図と能力が含まれます市場価値の回復を可能にするために。（vi）会社が投資を売却する必要が生じる可能性が高いかどうかの評価市場価値が回復する前、そして（vii）出来事や状況の変化から、投資の帳簿価が回収できない可能性があるかどうか。

ソフトウェア開発コスト

当社はASC 985の規定に従っています。ソフトウェア、ソフトウェアを外部に販売するためのソフトウェア開発費は、技術的実現可能性が確立するまで発生した費用として支出する必要があります。その時点で、それらの費用は、ソフトウェアが一般リリース可能になるまで資産計上され、推定耐用年数にわたって償却されます 10年。2024年と2023年9月30日に終了した3か月間には、いいえソフトウェア開発に関連する研究開発費を記録に残します。技術的な実現可能性は、検証された作業モデルが完成したときに確立されます。

収益認識

ASC 606に従って、顧客との契約による収益、当社は、顧客が約束した商品やサービスの管理権を得たときに収益を認識します。会社は、それらの商品やサービスと引き換えに受け取ると予想される対価を反映した収益額を記録します。会社はこの金額を決定するために次の5段階のモデルを適用します：（i）契約における約束された商品またはサービスの特定、（ii）約束された商品またはサービスが履行義務であるかどうかの判定（契約の文脈における区別があるかどうかを含む）、（iii）変動対価の制約を含む取引価格の測定、（iv）履行義務への取引価格の配分、（v）収益の計上です。または）会社はそれぞれの業績を満たしています義務。

当社は、顧客に譲渡する商品やサービスと引き換えに、受けるべき対価を徴収する可能性がある場合にのみ、5段階モデルを契約に適用します。契約開始時に契約がASC 606の範囲内にあると判断されると、会社はその契約を見直して、履行しなければならない履行義務と、これらの履行義務のうちどれが異なるかを判断します。特定の契約には、顧客が追加サービスを受けるためのオプションがあります。会社はこれらの選択肢を評価して、重要な権利が存在するかどうかを判断します。その評価の結果、重要な権利が存在すると判断された場合は、更新オプションのアプローチに基づいて重要な権利に価値を割り当てます。当社は、履行義務が履行されたとき、または履行されたときに、各履行義務に割り当てられる取引価格の金額を収益として認識します。会社は、現在の支払い権の原則と顧客の承認を指標として、顧客への支配権の移転がある時点で行われるかどうかを判断します。売上税やその他の同様の税金は収益から除外されます。

収益コスト

収益コストは、人件費、家賃、実験用消耗品、減価償却、および収益創出活動に直接関連するサンプル収集費用を含む、提供されるサービスに直接起因する費用で構成されます。

研究開発費

研究開発費は主に、KidneyIntelx技術の開発に関連して発生する社内外の人件費と、KidneyIntelx.dkdの臨床的価値、性能、有用性をさらに高めるための研究や臨床試験に関連する費用で構成されています。研究開発費は発生時に支出されます。

株式ベースの報酬

当社は、従業員および非従業員に付与される株式ベースの報奨を、付与日の推定公正価値に基づいて測定し、各報奨の権利確定期間である必要なサービス期間におけるそれらの報奨の報酬費用を計上します。当社は、没収が発生した時点でその旨を把握しています。サービスベースの権利確定条件を伴う株式ベースの報奨については、当社はサービス期間中の報酬費用を定額ベースで計上します。各ストックオプション付与の公正価値は、ブラック・ショールズのオプション価格モデルを使用して付与日に見積もられます。このモデルでは、予想される株価の変動性、オプションの予想期間、オプションの予想期間に近い期間のリスクフリー金利、会社の予想配当利回りなど、特定の主観的な仮定に基づいた入力が必要です。会社は

privately-held organization prior to November 2018 and has been a publicly-traded company for a limited period of time and therefore lacks company-specific historical and implied volatility information for its shares. Accordingly, the Company estimates its expected share price volatility based on the historical volatility of publicly-traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is none based on the fact that the Company has never paid cash dividends on ordinary shares and does not expect to pay any cash dividends in the foreseeable future.

The Company classifies share-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.

Income taxes

Income taxes are accounted for under the asset and liability method as required by FASB ASC Topic 740, Income Taxes ("ASC 740"). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A reduction in the carrying value of the deferred tax assets is required when it is not more likely than not that such deferred tax assets are realizable.

FASB ASC Subtopic 740-10, Accounting for Uncertainty of Income Taxes (ASC "740-10"), defines the criterion an individual tax position must meet for any part of the benefit of the tax position to be recognized in financial statements prepared in conformity with U.S. GAAP. The Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not such tax position will be sustained on examination by the taxing authorities, based solely on the technical merits of the respective tax position. The tax benefits recognized in the financial statements from such a tax position should be measured based on the largest benefit having a greater than 50% likelihood of being realized upon ultimate settlement with the tax authority. In accordance with disclosure requirements of ASC 740-10, the Company’s policy on income statement classification of interest and penalties related to income tax obligations is to include such items as part of income tax expense.

The Company recorded an immaterial provision for income taxes for the three months ended September 30, 2024. The Company did not record a provision for income taxes for the three months ended September 30, 2023, as the Company generated losses for such periods. The Company periodically evaluates the realizability of its deferred tax assets based on all available evidence, both positive and negative. The realization of deferred tax assets is dependent on the Company’s ability to generate sufficient future taxable income during periods prior to the expiration of tax attributes to fully utilize these assets. The Company weighed both positive and negative evidence and determined that there is a continued need for a full valuation allowance on its deferred tax assets as of September 30, 2024. Should the Company determine that it would be able to realize its remaining deferred tax assets in the foreseeable future, an adjustment to its remaining deferred tax assets would cause a material increase to income in the period such determination is made. At September 30, 2024, the Company had no unrecognized tax benefits. The Company does not expect any material increase or decrease in its income tax expense, in the next twelve months, related to examinations or changes in uncertain tax positions.

Comprehensive loss

Comprehensive loss includes net loss as well as other changes in shareholders’ equity that result from transactions and economic events other than those with shareholders. For the periods presented, changes in shareholders’ equity include foreign currency translation as well as changes in fair value of the convertible note due to changes in instrument-specific credit risk. The change in instrument-specific credit risk was calculated as the change in the risk yield from the convertible debt issuance date to the valuation date. The instrument-specific credit risk at issuance date was calibrated such that the fair value of the convertible bond was equal to the issue price as of the issuance date. The risk yield was adjusted to reflect the change in credit spreads between the issuance date and the valuation date.

Net loss per ordinary share

The dilutive effect of convertible securities is calculated using the if-converted method. Under the if-converted method, interest charges applicable to the convertible debt as well as nondiscretionary adjustments which include any expenses or charges that are determined based on the income (loss) for the period are added back to net income. The convertible debt is assumed to have been converted at the beginning of the period (or at time of issuance, if later). For the three months ended September 30, 2024, under the if-converted method, the add back of nondiscretionary adjustments and inclusion of potentially converted shares would be anti-dilutive.

Emerging growth company

The Company is an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”). Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. The Company has elected to avail itself of this exemption and, therefore, while the Company is an emerging growth company it will not be subject to new or revised accounting standards at the same time that they become applicable to other public emerging growth companies that have not elected to avail themselves of this exemption.

Recently issued accounting pronouncements

In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses: Measurement of Credit Losses on Financial Instruments, which requires measurement and recognition of expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. This is different from the previous guidance as this will require immediate recognition of estimated credit losses expected to occur over the remaining life of many financial assets. The Company implemented ASU 2016-13 in the fiscal year beginning July 1, 2023 and evaluated the impact of ASU 2016-13 and it did not have a material impact on the consolidated financial statements.

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40), Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). ASU 2020-06 eliminates two of the three models in ASC 470-20 that require issuers to separately account for embedded conversion features and eliminates some of the requirements for equity classification in ASC 815-40-25 for contracts in an entity’s own equity. The guidance also requires entities to use the if-converted method for all convertible instruments in the diluted earnings per share calculation and generally requires them to include the effect of potential share settlement for instruments that may be settled in cash or shares. It is effective for annual periods beginning after December 15, 2023, and interim periods therein. The Company evaluated the effect of ASU 2020-06 and it is not expected to have a material impact on the consolidated financial statements.

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”). ASU 2023-07 expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. All disclosure requirements under ASU 2023-07 are also required for public entities with a single reportable segment. The guidance is effective for the fiscal year ending June 30, 2025, and subsequent interim periods, with early adoption permitted. The Company is currently evaluating the impact of adopting this standard on its consolidated financial statements and disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which provides for improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This guidance is effective for annual periods beginning after December 15, 2024, and the adoption of this standard is not anticipated to have a significant impact on the Company’s consolidated financial statements other than adding new disclosures, which the Company is currently evaluating.

5. Fair value measurements and the fair value option

Assets and liabilities recorded at fair value on a recurring basis in the consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:

•

Level 1—Quoted prices (unadjusted in active markets for identical assets or liabilities)

•

Level 2—Inputs other than quoted prices in active markets that are observable either directly or indirectly

•

Level 3—Unobservable inputs in which there is little or no market data, which require the Company to develop its own assumptions

This hierarchy requires the use of observable market data when available and to minimize the use of unobservable inputs when determining fair value. The following fair value hierarchy table presents information about the Company’s assets measured at fair value on a recurring basis:


	Fair value measurement at
	reporting date using
(in thousands)	(Level 1)		(Level 2)		(Level 3)
September 30, 2024
Assets:
Equity securities	$	776	$	—	$	—
Liabilities:
Convertible notes	$	—	$	—	$	8,242
June 30, 2024
Assets:
Equity securities	$	698	$	—	$	—
Liabilities:
Convertible notes	$	—	$	—	$	8,490

The Company accounts for its ownership of VericiDx securities at fair value in accordance with ASC 321, Investments-Equity Securities, with changes in fair value recorded in earnings as the fair value of VericiDx's ordinary shares is readily determinable via the London Stock Exchange. As of September 30, 2024, the Company owns 8,581,682 shares of VericiDx. Based on closing stock price of VericiDx, the fair value of the investment in VericiDx was $0.8 million and $0.7 million at September 30, 2024 and June 30, 2024, respectively.

As further described in Note 8, in April 2022 the Company issued convertible promissory notes (the “Notes”) to an investor. The fair value option, as prescribed by ASC 815, Derivatives and Hedging, was elected and applied in connection with the preparation of these consolidated financial statements. The fair value of the Notes is determined using a scenario-based analysis that estimates the fair value based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes available to the noteholders.

The Company adjusts the carrying value of the Notes to their estimated fair value at each reporting date, with qualifying increases or decreases in the fair value recorded as change in fair value of convertible promissory notes in the statements of operations and comprehensive loss. Changes in the fair value resulting from changes in the instrument-specific credit risk will be presented separately in other comprehensive income.


(in thousands)	September 30, 2024
Balance at July 1, 2024	$	8,490
Change due to payment of principal and interest		(1,235	)
Fair value adjustments		414
Change in credit risk		125
FX Impact		448
Balance at September 30, 2024	$	8,242

Non-financial assets and liabilities

The Company’s non-financial assets, which primarily consist of property and equipment and equity method investments, are not required to be measured at fair value on a recurring basis, and instead are reported at carrying value in its consolidated balance sheets. However, on a periodic basis or whenever events or changes in circumstances indicate that they may not be fully recoverable, the respective carrying value of non-financial assets are assessed for impairment and, if ultimately considered impaired, are adjusted and written down to their fair value, as estimated based on consideration of external market participant assumptions.

6. Property and equipment, net and intangibles

Property and equipment consist of the following:


(in thousands)	September 30, 2024			June 30, 2024
Lab equipment	$	388		$	388
Office equipment		127			127
Office furniture		—			—
Leasehold improvements		—			—
Total		515			515
Less accumulated depreciation		(313	)		(299	)
	$	202		$	216

Depreciation expense was $0.01 million and $0.1 million for the three months ended September 30, 2024 and 2023, respectively.

Software, which is included in other assets on the condensed consolidated balance sheets, consists of:


(in thousands)	September 30, 2024			June 30, 2024
Software	$	1,601		$	1,527
Less accumulated amortization		(732	)		(658	)
	$	869		$	869

Amortization expense was $0.05 million and $0.05 million for the three months ended September 30, 2024 and 2023, respectively.

As of September 30, 2024, the expected amortization expense for the next five years and thereafter is as follows:


(in thousands)
2025	$	141
2026		150
2027		133
2028		133
2029		133
Thereafter		179
	$	869

7. Accrued expenses and other current liabilities

Accrued expenses and other current liabilities consisted of the following:


(in thousands)	September 30, 2024		June 30, 2024
Consulting and professional fees	$	694	$	1,109
Research and development		215		892
Payroll and related benefits		259		388
License and royalty expense		831		787
Other		163		178
	$	2,162	$	3,354

8. Convertible Notes

In April 2022, the Company issued amortizing senior convertible bonds with a principal amount of $21.2 million in amortizing senior convertible bonds due in April 2027 (the "Bonds") to CVI Investments, Inc. (the "Convertible Bond Investor"). The Bonds were issued at 85% par value with total net proceeds of $18.0 million and accrue interest at an annual rate of 5.5%, payable quarterly in arrears, in cash or American Depositary Shares ("ADSs") valued at the ADS Settlement Price at the option of the Company. The principal and interest payments are due in equal quarterly installments starting in July 2022. The Bonds contain various conversion and redemption features. The initial conversion price for the Bonds of $8.70 has been set at a 20 percent premium to the Reference ADS Price. The Conversion Price may reset down at 12, 24 and 36 months, depending on share price performance, and the Bonds have a hard floor in the conversion price of $7.25. As a result of the February 2023 private placement and pursuant to conditions of the bond agreement, the conversion price was adjusted to $8.2508 (previously $8.70) and the floor price was adjusted to $6.8757 (previously $7.25). Further, pursuant to such agreement, effective April 7, 2023, the conversion price was adjusted from $8.2508 to $7.7924. Between amortization dates, the Convertible Bond Investor retains the right to advance future amortization payments, provided that (a) there shall be no amortization advancements during the first 12 months, (b) no more than two amortization advancements may occur in any 12-month period, and (c) no more than one amortization advancement may occur in any 3-month period. On March 28, 2024, the Company entered into a second amendment and restatement agreement with the Convertible Bond Investor, which further amended the terms of the Company’s existing bond agreement. This Amendment to the bond agreement, among other things:

•

implemented a beneficial ownership limitation whereby each bondholder, together with its affiliates, must not at any time own or acquire the beneficial ownership of more than 9.99% of the issued and outstanding ordinary shares of the Company;

•

adjusted the bondholder’s maximum trading volume by removing a cap on the number of ADS that can be sold each day and reduced the length of certain non-trading periods applicable to the bondholders;

•

reduced certain market price observation periods to 5 days and 3 days (rather than 10 days and 5 days);

•

granted the holders of more than 50% of the principal amount of the bonds issued thereunder and then-outstanding (the “Majority Bondholders”) the right to defer the amortization payment scheduled for April 7, 2024 (the “April 2024 Amortized Payment Amount”) in addition to the deferrals already permitted as well as the right to accelerate the April 2024 Amortized Payment Amount if previously deferred in addition to the accelerations already permitted; and

•

in addition to the existing right to accelerate the next scheduled amortization payment, provide the Majority Bondholders the ability to accelerate any other future scheduled amortization payment, subject to certain limitations.

The Company performed an analysis and determined that the financial impact was immaterial as the amended and restated agreement was not substantially different than the previous agreement.

The Convertible Bond Investor is also permitted to defer up to two amortization payments to a subsequent amortization date. The Company retains the option to repay any deferred amortization in cash at 100 percent of the nominal amount. In July 2023, the Company made a cash amortization payment of $1.4 million, which consisted of $1.1 million of principal and $0.3 million of interest. Also, in July 2023, the Convertible Bond Investor exercised its right to advance an amortization payment and the Company made an accelerated repayment of $1.1 million through the issuance of 526,211 ADSs. In October 2023, the Company made an amortization payment of $1.3 million, which consisted of $1.1 million of principal and $0.2 million of interest, through the issuance of 2,335,388 ordinary shares in the form of 150,000 ordinary shares and 1,092,694 ADSs. In December 2023, the Company made an amortization payment of $1.3 million, which consisted of $1.1 million of principal and $0.2 million of interest, through the issuance of 2,500,000 ordinary shares and a cash payment of $0.6 million. In April 2024, the Company made an amortization payment of $1.3 million, which consisted of $1.1 million of principal and $0.2 million of interest, through the issuance of 3,636,162 ordinary shares. In July

9. Leases

The Company leases certain office space and laboratory space. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. The Company does not recognize right-of-use assets or lease liabilities for leases determined to have a term of 12 months or less. Many of the Company's leases contain variable non-lease components such as maintenance, taxes, insurance, and similar costs for the spaces it occupies.

Variable executory costs, as it relates to net leases, are excluded from the calculation of the lease liability. Variable executory costs include costs relating to utilities, repairs, maintenance, insurance, common area expenses, and taxes paid for the leased asset during its economic life.

Upon adoption of ASC 842, the Company elected the package of practical expedients and the hindsight practical expedient but did not elect the easement practical expedient which is not applicable to the Company as the Company does not have any ground leases. In accordance with the package of practical expedients, the Company has not reassessed any of their existing or expired contracts or any other agreements that were previously concluded to not contain a lease for the following practical expedient guidance: (1) whether the arrangement is or contains a lease, (2) lease classification and (3) whether previously capitalized costs continue to qualify as initial direct costs.

The Company leased lab space in Salt Lake City, UT, under a five-year lease, the term of which commenced in November 2019. The Company has measured its right-of-use assets and lease liabilities based on lease terms ending in October 2024. The Company consolidated Utah lab operations in November 2023, using it as an office space instead of lab space. After the end of the lease in October 2024, the Company will maintain the space on a month-to-month term.

The Company leased lab space in New York City, NY, under an initial three-month lease, the term of which commenced in February 2019. The Company has classified this lease as a short-term lease as the Company concluded that the noncancelable terms of this lease was less than one year at the commencement and none of the Company's renewals or amendments were for additional noncancelable terms greater than one year.

The Company leased office space in New York City, NY, under an initial month-to-month term, the term of which commenced in June 2018. The lease did not have termination or formal renewal options however the Company can renew their office space if they are still needed and are still available at the end of the term. The Company has classified this lease as a short-term lease as the Company concluded that the noncancelable terms of this lease was less than one year at the commencement and none of the Company's renewals or amendments were for additional noncancelable terms greater than one year.

The Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities during the adoption of ASC 842:

As the Company's leases do not provide an implicit rate, it concluded that a 10.0% IBR, the approximate midpoint between the average commercial real estate loans during 2022, is an appropriate discount rate to use for the Utah lease, which was the only lease existing as of the adoption date.

The following table shows the lease balance sheet classification of leases for the three months ended September 30, 2024:


(in thousands)	September 30, 2024
Assets
Operating lease right-of-use assets, net of accumulated amortization	$	—
Liabilities
Current	$	11
Operating lease liabilities, current
Non-current
Operating lease liabilities, non-current		—
Total lease liabilities	$	11

The following table shows the lease costs for the three months ended September 30, 2024:


Lease costs (in thousands)	Statement of operations classification	September 30, 2024
Operating lease costs	Operating expenses: research and development	$	(2	)
Short-term lease costs	Operating expenses: research and development		3
Short-term lease costs	Operating expenses: general and administrative		18
Short-term lease costs	Cost of goods sold		95
Total lease costs		$	114


Other information	September 30, 2024
Cash paid for amounts included in the measurement of lease liabilities (in thousands)	$	(2	)
Remaining lease term - operating leases (in years)		0.1
Discount rate - operating leases		10	%

The future minimum payments for noncancelable leases with terms in excess of one year as of September 30, 2024 are payable as follows:


(in thousands)
2025	$	11.6
2026		—
2027		—
Total minimum lease payments		11.6
Less amounts representing interest		(0.1	)
Present value of lease liabilities	$	11.5

The Company is not a party to any litigation and does not have contingency reserves established for any litigation liabilities. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies.

11. License and services agreements

Mount Sinai license and sponsored research agreements

On May 30, 2018, the Company entered into an exclusive license agreement (the “ISMMS License Agreement”) and on March 7, 2019, a sponsored research agreement (the “ISMMS SRA”) with Mount Sinai. Under the terms of the ISMMS License Agreement, ISMMS granted the Company (i) an exclusive, sublicensable license to use certain patent rights covering specific inventions concerning the utilization of biomarkers guided artificial intelligence techniques for detecting kidney functional decline (the “ISMMS Technology”), (ii) a non-exclusive license under unregistered licensed copyrights and licensed know-how and (iii) an exclusive option to obtain licensed technology conceived after May 30, 2018. The Company is obligated to pay Mount Sinai $1.5 million and $7.5 million in commercial milestone payments upon achieving worldwide net sales of KidneyIntelX of $50.0 million and $300.0 million, respectively. The Company is also obligated to pay Mount Sinai a 4% to 5% royalty on net sales of KidneyIntelX, subject to customary reductions. Royalties are payable on a product-by-product basis from first commercial sale of such product until the later of (1) expiration of the last valid claim of a licensed patent covering such product or (2) on a country-by-country basis, 12 years from first commercial sale of such product in such country. Moreover, the Company is obligated to pay Mount Sinai between 15% and 25% of any consideration received from a sublicensee.

As part of the ISMMS SRA, the Company has agreed to fund several research projects to further develop the ISMMS Technology. The Company incurred $0.1 million and $0.3 million related to the ISMMS SRA for the three months ended September 30, 2024 and 2023, respectively.

Mount Sinai Clinical Trial agreement

In July 2021, the Company entered into a Clinical Trial Agreement (the "CTA") with ISMMS. Under the CTA, ISMMS will undertake a sponsored clinical trial entitled, “A prospective decision impact trial of KidneyIntelX in patients with Type 2 diabetes and existing chronic kidney disease”. The clinical trial is to be conducted at ISMMS with Renalytix agreeing to pay ISMMS in accordance with the agreed upon budget. The clinical trial is expected to last up to four years with a total estimated budget of $3.2 million. As of September 30, 2024, amounts due to ISMMS under the CTA totaled $0.04 million, and $0 was expensed during the three months ended September 30, 2024. At September 30, 2023, amounts due to ISMMS under the CTA totaled $0.7 million, and $0.3 million was expensed during the three months ended September 30, 2023.

Joslin Diabetes Center agreement

In October 2018, the Company purchased a worldwide exclusive license agreement (the “Joslin Agreement”) with the Joslin Diabetes Center, Inc. (“Joslin”) that was previously entered into with EKF Diagnostics Holding plc (“EKF”), a related party, in July 2017. The license agreement provides the Company with the right to develop and commercialize licensed products covering a novel methodology of diagnosing and predicting kidney disease using certain biomarkers (the “Joslin Diabetes Technology”).

Under the terms of the Joslin Agreement, the Company is obligated to pay Joslin aggregate commercial milestone payments of $0.3 million and $1.0 million upon achieving worldwide net sales of licensed products and processes of $2.0 million and $10.0 million, respectively. The Company is also obligated to pay Joslin a 5% royalty on net sales of any licensed products or licensed processes, subject to customary reductions. Moreover, the Company is obligated to pay Joslin 25% of any consideration received from a sublicensee. The Company accrued $0.3 million related to achievement of the first sales milestone and accrued $0.4 million of royalties due to Joslin as of September 30, 2024, which were recorded as cost of revenue within the consolidated statements of operations and comprehensive loss. The Company accrued $0.3 million of royalties due to Joslin for the three months ended September 30, 2023.

•

60,000 options vest 25% three months following Vesting Commencement Date and the remaining shares vest monthly thereafter;

•

12,500 options vest quarterly over two years following the grant date; and

•

10,000 options vested on the vesting commencement date.

If options remain unexercised after the date one day before the tenth anniversary of grant, the options expire. On termination of employment, any options that remain unexercised are either forfeited immediately or after a delayed expiration period, depending on the circumstances of termination. Upon the exercise of awards, new ordinary shares are issued by the Company.

The Company recorded share-based compensation expense in the following expense categories in the consolidated statements of operations for the three months ended September 30, 2024 and 2023:


	Three Months Ended September 30,
(in thousands)	2024		2023
Research and development	$	66	$	97
General and administrative		187		424
Cost of revenue		1		3
	$	254	$	524

The fair value of options is estimated using the Black-Scholes option-pricing model, which takes into account inputs such as the exercise price, the value of the underlying ordinary shares at the grant date, expected term, expected volatility, risk-free interest rate and dividend yield. The fair value of each grant of options during the three months ended September 30, 2024 and 2023 were determined using the methods and assumptions discussed below.

•

The expected term of employee options is determined using the “simplified” method, as prescribed in SEC’s Staff Accounting Bulletin No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option due to the Company’s lack of sufficient historical data.

•

The expected volatility is based on historical volatility of the publicly-traded common stock of a peer group of companies.

•

The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected term.

•

The expected dividend yield is none because the Company has not historically paid and does not expect for the foreseeable future to pay a dividend on its ordinary shares.

For the three months ended September 30, 2024 and 2023, the grant date fair value of all option grants was estimated at the time of grant using the Black-Scholes option-pricing model using the following weighted average assumptions:


	Three Months Ended September 30,
	2024			2023
Expected term (in years)		6.3			6.4
Expected volatility		83.2	%		74.3	%
Risk-free rate		4.0	%		4.3	%
Dividend yield		—	%		—	%

The weighted average fair value of the options granted during the three months ended September 30, 2024 and 2023 was $0.14 and $0.92 per share, respectively.

The following table summarizes the stock option granted to employees and non-employees for the three months ended September 30, 2024:


	Number of shares under option plan			Weighted- average exercise price per option		Weighted- average remaining contractual life (in years)
Outstanding at June 30, 2024		7,473,866		$	3.06		7.0
Granted		517,500		$	0.24
Exercised		—		$	-
Forfeited		(75,184	)	$	1.62
Expired		—		$	-
Outstanding at September 30, 2024		7,916,182		$	3.06		6.9
Exercisable at September 30, 2024		5,639,979		$	3.87		6.0
Vested and expected to vest at September 30, 2024		7,916,182		$	3.06		6.9

As of September 30, 2024, there was $1.27 million in unrecognized compensation cost related to unvested options that will be recognized as expense over a weighted average period of 1.64 years. The aggregate intrinsic value of options outstanding and options exercisable at each of September 30, 2024 and September 30, 2023 was $0.

Employee Share Purchase Plan

The Company’s 2020 Employee Share Purchase Plan (the “ESPP”) became effective on August 17, 2020. The ESPP authorizes the issuance of up to 850,000 shares of the Company’s common stock. The number of shares of the Company’s common stock that may be issued pursuant to rights granted under the ESPP shall automatically increase on January 1st of each year, commencing on January 1, 2021 and continuing for 10 years, in an amount equal to the lesser of one percent of the total number of shares of the Company’s common stock outstanding on December 31st of the preceding calendar year, and 2,000,000 ordinary shares, subject to the discretion of the Board of Directors or remuneration committee to determine a lesser number of shares shall be added for such year.

Under the ESPP, eligible employees can purchase the Company’s common stock through accumulated payroll deductions at such times as are established by the Board of Directors or remuneration committee. Eligible employees may purchase the Company’s common stock at 85% of the lower of the fair market value of the Company’s common stock on the first day of the offering period or on the purchase date. Eligible employees may contribute up to 15% of their eligible compensation. Under the ESPP, a participant may not purchase more than $25,000 worth of the Company’s common stock for each calendar year in which such rights are outstanding. No shares were purchased under the ESPP during the three months ended September 30, 2024 and 2023.

In accordance with the guidance in ASC 718-50, Compensation – Stock Compensation, the ability to purchase shares of the Company’s common stock at 85% of the lower of the price on the first day of the offering period or the last day of the offering period (i.e., the purchase date) represents an option and, therefore, the ESPP is a compensatory plan under this guidance. Accordingly, share-based compensation expense is determined based on the option’s grant-date fair value as estimated by applying the Black-Scholes option-pricing model and is recognized over the withholding period. The Company recognized share-based compensation expense of $0 and $0.01 million in general and administrative expense and $0 million and $0.01 million in research and development expense during the three months, ended September 30, 2024 and 2023, respectively, related to the ESPP.

Restricted Stock Units

Activity for restricted stock units for the three months ended September 30, 2024 is as follows:


	Number of Restricted Stock Units			Weighted- average Grant Date Fair Value
Non-vested balance at June 30, 2024		7,930		$	1.33
Granted		—		$	-
Vested		(3,915	)	$	1.69
Forfeited		(875	)	$	1.69
Non-vested balance at September 30, 2024		3,140		$	1.69

15. Net loss per ordinary share

Basic net loss per ordinary share is computed by dividing net loss by the weighted average number of ordinary shares outstanding during each period. Diluted net loss per ordinary share includes the effect, if any, from the potential exercise or conversion of securities, such as options which would result in the issuance of incremental ordinary shares. Potentially dilutive securities outstanding as of September 30, 2024 and 2023 have been excluded from the computation of diluted weighted average shares outstanding as they would be anti-dilutive. Therefore, the weighted average number of shares used to calculate both basic and diluted net loss per share are the same.

The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of ordinary shares outstanding as they would be anti-dilutive:


	Three Months Ended September 30,
	2024		2023
Stock options to purchase ordinary shares		7,916,182		7,518,257
Restricted stock units		3,140		49,520
Conversion of convertible note		2,992,660		4,625,019
		10,911,982		12,192,796

On September 30, 2024, the Company announced that it had received commitments from existing and new investors to raise £11.8 million through a subscription of 131,161,556 new ordinary shares at £0.09 per share. The Company also agreed to issue 36,550,543 new ordinary shares at £0.09 per share to convert part of the existing convertible notes to equity and separately to convert part of the accounts payable balances to equity. In respect of the convertible notes, the Company converted approximately £2.97 million of the notes to equity via the issuance of 33 million new ordinary shares and the remaining balance treated as new unsecured convertible notes with interest at a rate of 5.5% per annum payable quarterly in cash, or 7.5% per annum if rolled into the principal amount of the debt (paid-in-kind), at the discretion of the Company. The new convertible notes are non-amortizing, have a maturity date of July 31, 2029 and may not be converted before April 1, 2026. The notes are callable at the Company’s option at any time prior to maturity. In respect to the accounts payable balance with a professional adviser, $750,000 has been restructured such that $425,000 of the balance has been converted into equity, and $325,000 has been restructured as a long term promissory note bearing paid- in-kind interest at 5% per annum. The new note will be due at the earlier of 5 years from the initiation of the note, or accelerated should the Company be acquired prior to maturity. The Company may prepay the note at any time without penalty. The equity financing commitments closed in two tranches, the first on October 8, 2024 and the second on November 4, 2024 with all net proceeds received by the Company on the closing dates. All debt restructurings were effective with the second close of the equity financing.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited consolidated financial statements and related notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q, our audited consolidated financial statements and related notes for the year ended June 30, 2024, included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on September 30, 2024 (the “Annual Report on Form 10-K”), as well as the information contained under Management’s Discussion and Analysis of Financial Condition and Results of Operations and "Risk Factors" contained in the Annual Report on Form 10-K, and Part II, Item 1A "Risk Factors" of this Quarterly Report on Form 10-Q, and other information provided from time to time in our other filings with the SEC.

Renalytix is focused on providing doctors around the world with a safe, reliable and effective tool to identify which patients are or are not in danger of losing significant kidney function and falling into kidney failure and may require long-term dialysis or a kidney transplant. Chronic kidney disease is one of the largest urgent medical needs, globally affecting an estimated 850 million people, and is responsible for an unsustainable and growing societal cost burden.

We believe an important part of the answer is preventative medicine and the ability to identify individuals with advancing chronic kidney disease early, where new drug therapies and clinical strategies have the optimal chance to stop uncontrolled disease progression.

At Renalytix, we have developed kidneyintelX.dkd, the first U.S. Food and Drug Administration ("FDA") authorized in vitro prognostic test that uses an artificial intelligence-enabled algorithm to aid in assessment of the risk of progressive decline in kidney function. The test is designed to predict early in the progression of kidney disease who is at risk for significant sustained decline in kidney function. Prognostic tests, such as kidneyintelX.dkd, are not intended for diagnosing any disease or for monitoring disease progression or the effect of any therapeutic product. Rather, prognostic tests are intended to be used in conjunction with other clinical and diagnostic findings and consistent with professional standards of practice, including information obtained by alternative methods, and clinical evaluation, as appropriate. When used as intended, potential interventions can be considered early, ideally before major damage is done and when treatments can be most effective. KidneyintelX.dkd is part of a family of clinical tests being developed from the KidneyIntelX technology platform developed using technology licensed from the Icahn School of Medicine at Mount Sinai in New York, the Joslin Diabetes Center in Boston and under development through U.S. and international collaborations.

We are deploying kidneyintelX.dkd to patient populations with DKD on a regional basis through partnerships with healthcare systems and insurance payors that provide coverage to those healthcare systems’ patients. In June 2024 , Medicare issued a final Local Coverage Determination (“LCD”) for the Company’s kidneyintelX.dkd testing and is effective for dates of service on or after August 1, 2024. The established Medicare price for kidneyintelX.dkd is $950 per test. Distinct CPT Codes (Common Procedural Terminology Codes) have been established for kidneyintelX.dkd and is published in CMS’ 2024 Clinical Lab Fee Schedule. The LCD specifies coverage for use of kidneyintelX.dkd for patients with diagnosed Type 2 diabetes and Stage 1-3b Chronic Kidney Disease is reasonable and necessary. The LCD was issued by National Government Services (“NGS”). NGS is a subsidiary of Elevance Health, Inc. (previously Anthem, Inc.), a Medicare Administrative Contractor responsible for claims processing for testing performed in the Company’s New York City laboratory.

Since our inception in March 2018, we have focused primarily on organizing and staffing our company, raising capital, developing KidneyIntelX technology, conducting clinical validation studies for kidneyintelX.dkd, establishing and protecting our intellectual property portfolio and commercial laboratory operations, pursuing regulatory approval, developing our reimbursement strategy and commercializing our testing services. We have funded our operations primarily through equity and debt financings.

There is always the possibility that a change in the regulatory or reimbursement landscape can have an impact on our ability to deliver commercial kidneyintelX.dkd testing services in the United States, maintain the current and anticipated costs and services reportable result turnaround times. Any of the aforementioned changes could materially alter our revenue projections.

Unfavorable conditions in the economy in the United States and abroad may negatively affect the growth of our business and our results of operations. For example, macroeconomic events, including conflicts in Ukraine-Russia and Middle East, increased inflation rates and U.S. and U.K. interest rates, have led to economic uncertainty globally. The effect of macroeconomic conditions may not be fully reflected in our results of operations until future periods. If, however, economic uncertainty increases or the global economy worsens, our business, financial condition and results of operations may be harmed. For further discussion of the potential impacts of macroeconomic events on our business, financial condition, and operating results, see the section titled “Risk Factors” in the Company's Annual Report on Form 10-K.

In May 2018, we entered into the Mount Sinai Agreement, with Mount Sinai, pursuant to which we obtained a worldwide, royalty-bearing, exclusive license under certain patents and a worldwide, royalty-bearing, non-exclusive license under certain know-how of Mount Sinai to develop and commercialize licensed products in connection with the application of artificial intelligence for the diagnosis of kidney disease. Pursuant to the terms of the Mount Sinai Agreement, we are obligated to use commercially reasonable efforts in connection with the development and commercialization of the licensed technologies, including in accordance with specified diligence milestones.

Under the terms of the Mount Sinai Agreement, we are obligated to pay Mount Sinai $1.5 million and $7.5 million in commercial milestone payments upon achieving worldwide net sales of kidneyintelX.dkd testing services of $50.0 million and $300.0 million, respectively. We are also obligated to pay Mount Sinai a 4% to 5% royalty on net sales of kidneyintelX.dkd, subject to customary reductions. Royalties are payable on a product-by-product basis from first commercial sale of such product until the later of (1) expiration of the last valid claim of a licensed patent covering such product or (2) on a country-by-country basis, 12 years from first commercial sale of such product in such country. Moreover, we are obligated to pay Mount Sinai between 15% and 25% of any consideration received by us from a sublicensee. The two provisional patent applications covering the KidneyIntelX diagnostic in-licensed under the Mount Sinai Agreement were filed in February 2020 and April 2020, respectively.

The Mount Sinai Agreement expires on the later of the tenth anniversary of the execution of the agreement and expiration of the last remaining royalty term. We may terminate the Mount Sinai Agreement at any time upon 90 days’ prior written notice. Mount Sinai may terminate the agreement for our uncured material breach, our failure to meet certain diligence milestones, our insolvency, or in the event that we challenge the validity or enforceability of any licensed patent.

In July 2017, EKF entered into the Joslin Agreement with Joslin. In October 2018, we purchased all of EKF’s rights, title, interest and benefit in the Joslin Agreement in exchange for the issuance of 15.4 million of our ordinary shares.

Pursuant to the Joslin Agreement and the related assignment from EKF, we obtained a worldwide, royalty-bearing, exclusive license under any patents and any related know-how of Joslin related to the patent application filed with respect to the Joslin IP to make, have made, use, offer for sale and sell licensed products covered by claims in the Joslin IP, and to perform, practice offer for sale and sell certain licensed processes related to the Joslin IP. We are obligated to use commercially reasonable efforts in connection with the development and commercialization of the licensed products and licensed processes, including in accordance with a development plan.

Under the terms of the Joslin Agreement, we are obligated to pay Joslin aggregate commercial milestone payments of $0.3 million and $1.0 million in commercial milestone payments upon achieving worldwide net sales of licensed products and processes of $2.0 million and $10.0 million, respectively. We are also obligated to pay Joslin a 5% royalty on net sales of any licensed products or licensed processes, subject to customary reductions. Moreover, we are obligated to pay Joslin 25% of any consideration received by us from a sublicensee.

The Joslin Agreement initially expires on July 31, 2025, and is subject to an automatic five-year extension unless either party notifies the other party of its intent not to extend the agreement at least 180 days prior to initial expiration. Either party may terminate the Joslin Agreement earlier upon an uncured material breach of the agreement by the other party, the insolvency of the other party, or in the event the other party is unable to perform its obligations under the agreement for a specified period. Additionally, Joslin may terminate the agreement in the event that we cease developing or commercializing licensed products or processes, if we fail to maintain certain required insurance policies, and if we fail to pay patent expenses related to the licensed patents.

During the three months ended September 30, 2024 and 2023, we continued to deploy kidneyintelX.dkd to patient populations with DKD, on a regional basis through partnerships with healthcare systems and insurance payors that provide coverage to those healthcare systems’ patients. If these strategic partners fail to meet their key contractual obligations or to purchase kidneyintelX.dkd tests, it will likely have an adverse effect on us and our ability to achieve our commercial objectives, potentially including the attainment of sales volumes leading to profitability.

During the three months ended September 30, 2024 and 2023, cost of revenue consists of costs directly attributable to the kidneyintelX.dkd testing and services rendered, including labor, lab consumables and sample collection costs directly related to revenue generating activities.

Research and development costs consist primarily of costs incurred in connection with the development of KidneyIntelX technology. We are continuing to conduct limited clinical utility and other studies for kidneyintelX.dkd to expand long-term, prospective clinical value and performance in chronic kidney disease. We expense research and development costs as incurred.

We incur both direct and indirect expenses related to our research and development programs. Direct expenses include third-party expenses related to our programs such as expenses for data science and artificial intelligence capabilities, consulting fees, lab supplies, assay development services and clinical validation costs. Indirect expenses include salaries and other personnel-related costs, including share-based compensation for personnel in research and development functions and rent.

At the end of the reporting period, we compare payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that we estimate to have been made as a result of the service provided, we may record net prepaid or accrued expense relating to these costs. Upfront milestone payments made to third parties who perform research and development services on our behalf are expensed as services are rendered.

General and administrative expenses consist principally of salaries and other personnel-related costs including share-based compensation; professional fees for accounting, auditing, tax and administrative consulting services; legal fees relating to patent and corporate matters; administrative travel expenses; insurance costs; marketing expenses and other operating costs. Additionally, general and administrative expenses include the cost of maintaining our admission to AIM, Nasdaq and OTC trading.

Foreign currency gain (loss), net consists of foreign currency income (losses) due to exchange rate fluctuations on transactions denominated in a currency other than our functional currency.

In October 2020, the Company completed a spinoff of VericiDx, a developer of advanced clinical diagnostics for organ transplant and retained 9,831,681 ordinary shares of VericiDx. The Company accounts for the investment in VericiDx equity securities at fair value, with changes in fair value recognized in the consolidated statements of operations and comprehensive loss. As of September 30, 2024, the Company owns 8,581,682 shares of VericiDx

Other income relates to interest income earned on our cash deposits, grant income earned for work performed under the Horizon Europe grant and other services provided to academic institutions or pharmaceutical companies. Other expense relates to realized loss on the sale of VericiDx shares.

During the three months ended September 30, 2024, we recognized $0.52 million of revenue related to sales of KidneyIntelX. During the three months ended September 30, 2023, we recognized $0.46 million revenue related to sales of KidneyIntelX.

During the three months ended September 30, 2024, we recognized cost of revenue of $0.4 million primarily attributable to KidneyIntelX testing, including labor, lab consumables and sample collection costs related to revenue generating activities. We recognized $0.5 million of cost of revenue for the three months ended September 30, 2023.

Research and development expenses decreased by $1.9 million from $2.8 million for the three months ended September 30, 2023 to $0.9 million for the three months ended September 30, 2024. The decrease was attributable to a $1.7 million decrease related to external R&D projects and studies with Mount Sinai and Wake Forest, $0.2 million decrease related to consulting and professional fees, $0.1 million decrease in other miscellaneous expenses, offset by $0.2 million increase in compensation and related benefits.

General and administrative expenses decreased $2.8 million from $6.0 million for the three months ended September 30, 2023 to $3.3 million for the three months ended September 30, 2024. The decrease was driven by even further cost cutting measures, which resulted in a $1.5 million decrease in compensation and related benefits, including share-based payments and bonuses, due to decreased headcount, $0.6 million decrease in consulting and professional fees, $0.2 million decrease in insurance costs, $0.2 million decrease in marketing, and $0.3 million decrease in other operating expenses. We have implemented a plan to further reduce payroll expense and total general and administrative expenses while preserving our sales capacity.

In connection with the delisting of our ADSs from Nasdaq effective on October 7, 2024, and our ADSs becoming quoted on the OTC Markets’ OTCQB tier effective on October 8, 2024, we anticipate that we will requalify as a foreign private issuer (“FPI”) at our next testing date for FPI status. As a foreign private issuer, we expect annual cost savings of up to $1.5 million from a reduction in regulatory filing costs, professional fees (audit, legal, and consulting), listing fees, insurance and other administrative costs when fully implemented.

During the three months ended September 30, 2024, we recognized a foreign currency gain of $0.04 million due to exchange rate fluctuations on transactions denominated in a currency other than our functional currency. During the three months ended September 30, 2023, we recognized a foreign currency gain of $0.3 million primarily attributable to cash balances denominated in currencies other than our functional currency, GB Pounds.

We account for the investment in VericiDx equity securities at fair value, with changes in fair value recognized in the income statement. During the three months ended September 30, 2024, we recorded a gain of $0.1 million to adjust the VericiDx investment to fair value. During the three months ended September 30, 2023, we recorded a loss of $0.5 million to adjust the VericiDx investment to fair value.

We elected to account for the bonds at fair value with qualifying changes in fair value recognized through the consolidated statements of operations and comprehensive loss until the notes are settled. This excludes fair value adjustments related to instrument-specific credit risk, which is recognized in other comprehensive income (OCI). For the three months ended September 30, 2024, we recorded a loss of $0.8 million to adjust the bonds to fair value. For the three months ended September 30, 2023, we recorded a loss of $1.2 million to adjust the bonds to fair value. The change in fair value of the bond was driven by a decrease in term to maturity, increase in risk free rate and change in stock price.

During the three months ended September 30, 2024, we realized $0.01 million of other expense which included $0.014 million of interest income earned on our cash deposits and $0.024 million of grant income, offset by $0.042 million of realized loss on the sale of VericiDx shares. During the three months ended September 30, 2023, we realized $0.1 million of income related to interest income earned on our cash deposits

Since our inception, we have incurred net losses. We incurred net losses of $4.7 million and $10.2 million for the three months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $216.5 million.

In connection with the Company's previously equity fundraising (the “Fundraise”), the Company also announced a revision to the terms of its £8.7 million amortizing senior convertible bond (the “Convertible Bond”) held by a fund advised by Heights Capital Ireland LLC (the "Convertible Bond Investor"), subject to the closing of the Fundraise which closed in two tranches on October 7,

2024 and November 4, 2024. Under the completed terms, the Convertible Bond was partially repaid and restructured as follows: (i) £2.97 million of the Convertible Bond was converted to equity via issue to the Convertible Bond Investor of 33 million ordinary shares (the “Heights Conversion Shares”), at 9 pence per share price (the “Issue Price”) being offered in the Fundraise; and (ii) the balance of the Convertible Bond was restructured as a new unsecured convertible bond (the “New Convertible Bond”). The Heights Conversion Shares issued to the Convertible Bond Investor represented 9.9% of the Company’s enlarged issued share capital at such time. The Convertible Bond Investor is subject to a 6-month lock-up.

The New Convertible Bond will accrue interest quarterly at a rate of 5.5% per annum if paid in cash, or 7.5% per annum if rolled into the principal amount of the outstanding, at the discretion of the Company. The New Convertible Bond has maturity date of July 31, 2029 and may not be converted before April 1, 2026, except in the event that the Company undertakes a further qualifying equity issuance in the future (which would exclude securities properly issued to employees and other staff of the Company for bona fide remuneration and incentivisation purposes). The New Convertible Bond can be redeemed as follows:

Additionally, an accounts payable balance with a professional adviser of $750,000 (the “Advisor Accounts Payable Balance”) has been restructured such that $425,000 of the outstanding balance has been converted to equity at the Issue Price. The remaining $325,000 has been converted to a long term unsecured note (the “Advisor Loan Note”), bearing interest at 5% per annum, which will be rolled into the principal amount of the Advisor Loan Note. The principal and interest of the Advisor Loan Note will be repaid on the earlier of: (i) 5 years from the issuance of the Advisor Loan Note; or (ii) such earlier time as the Company is acquired by another company. Additionally, the Company has the right to redeem the Advisor Loan Note at any time without prepayment penalties.

The Company believes that the restructuring of the Convertible Bond and the Advisor Accounts Payable Balance, the creation of the New Convertible Bond and the Advisor Loan Note and the Creditor Write-offs, along with some ancillary debt restructuring, will substantially reduce the Company’s monthly cash burn.

The ordinary shares issued pursuant to the debt restructuring described in this section are approximately 36.5 million ordinary shares which were issued on November 4, 2024.

The Company received commitments from existing and new investors to raise £11.8 million through a subscription of 131,161,556 new ordinary shares at 9 pence per share. The equity financing commitments closed in two tranches, the first on October 8, 2024 and the second on November 4, 2024 with all net proceeds received by the Company on the closing dates.

We expect to incur additional losses in the near future, and we expect our expenses may increase in connection with our ongoing activities to further commercial scale of kidneyintelX.dkd testing services. While we expect our costs associated with operating as a public company in the United States to be reduced following our transition to OTC trading markets, there may be additional capital and professional resources required to satisfy ongoing US regulatory requirements. The timing and amount of our operating expenditures will depend largely on:

To date, we have primarily financed our operations through equity and debt financings. As of September 30, 2024, we had cash and cash equivalents of $0.9 million. We have incurred recurring losses and negative cash flows from operations since inception and had an accumulated deficit of $216.5 million as of September 30, 2024. We anticipate incurring additional losses until such time, if ever, that we can generate significant incremental sales of kidneyintelX.dkd or any future products currently in development.

If we decide and to the extent that we could potentially raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our shareholders.

Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or diagnostic products or grant licenses on terms that may not be favorable to us. Additional capital may not be available when needed, on reasonable terms, or at all, and our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States and worldwide. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, curtail or discontinue our product development or future commercialization efforts, or grant rights to develop and market products that we would otherwise prefer to develop and market ourselves.

We have limited sources of revenue to provide incoming cash flows to sustain our future operations. As outlined above, our ability to pursue our planned business activities is dependent upon our successful efforts to increase our testing revenue and the effectiveness of our expense management and other capital preservation measures. As discussed Note 16, Subsequent Events to the financial statements, subsequent to the end of the quarter ended September 30, 2024, the Company raised approximately $14.9 million, net of expenses, from additional rounds of equity in October and November 2024 and concurrently restructured a number of liabilities on the balance sheet. This additional equity funding, the reduction of cash expenses related to the Company’s liabilities, and an overall reduction in General and Administrative Expenses, have significantly changed the Company’s financial position. While the Company intends that this capital will be sufficient to fund the company through to cash flow positive operations, there can be no guarantee to that outcome.

The Company has incurred recurring losses and negative cash flows from operations since inception and had an accumulated deficit of $216.5 million as of September 30, 2024. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of kidneyintelX.dkd or any future products currently in development.

The Company’s ability to continue as a going concern is contingent upon successful execution of management’s intended plan over the next 24 months to improve the Company’s liquidity and profitability, which includes, without limitation:

As a result of the Company's losses and its projected cash needs, as defined in the accounting literature, substantial doubt exists about the Company’s ability to continue as a going concern. While subsequent to September 30, 2024, the company has successfully raised approximately $14.9 million, net of expenses, in new equity capital and restructured the existing long-term debt recorded on the balance sheet, the Company does have a history of operating losses and it has been expensive to deliver all of the milestones to

commercialize the kidneyintelX.dkd test. Should the Company require additional capital it may not be available on acceptable terms, or at all, and the Company may not be able to enter into strategic alliances or other arrangements on favorable terms, or at all. The terms of any future financing may adversely affect the holdings or the rights of the Company’s shareholders. Should it be necessary, if the Company is unable to obtain funding it could be required to delay, curtail or discontinue research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect its business prospects. As such, management has concluded that there is a going concern uncertainty. The consolidated financial statements do not include any adjustments that may result from the outcome of this going concern uncertainty.

We have based our future cash needs on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect or may fail in our efforts to enact additional cost reduction programs. Furthermore, our operating plan may change, and we may need additional funds sooner than planned in order to meet operational needs and capital requirements for product development and commercialization.

As discussed in Note 16, Subsequent Events to the financial statements, subsequent to the end of the quarter ended September 30, 2024, the Company closed additional rounds of equity financing in October and November 2024 and concurrently restructured a number of liabilities on the balance sheet. As a result, the Company believes that it has sufficient cash on the balance sheet to sustain current operations.

The following table shows a summary of our cash flows from operations for the periods indicated:

During the three months ended September 30, 2024, net cash used in operating activities was $3.8 million and was primarily attributable to our $4.7 million net loss as well as $1.0 million of noncash charges and $0.1 million net change in our operating assets and liabilities. Noncash charges were primarily related to $0.3 million in share-based compensation expense, $0.8 million fair value adjustment related to the bonds, $0.1 million of depreciation and amortization expense, offset by $0.1 million fair value adjustment on our VericiDx investment. The change in our operating assets and liabilities was primarily attributable to $0.4 million increase in accrued expenses and other current liabilities, $0.5 million decrease in accounts receivables, prepaids and other current assets.

During the three months ended September 30, 2023, net cash used in operating activities was $9.5 million and was primarily attributable to our $10.1 million net loss as well as $2.5 million of noncash charges and $1.9 million net change in our operating assets and liabilities. Noncash charges were primarily related to $1.0 million in share-based compensation expense, $0.9 million fair value adjustment related to the bonds, $0.4 million fair value adjustment on our VericiDx investment, $0.1 million of depreciation and amortization expense. The change in our operating assets and liabilities was primarily attributable to $1.0 million decrease in accrued expenses and other current liabilities, $0.9 million decrease in accounts receivables, prepaids and other current assets.

During the three months ended September 30, 2024, net cash provided by investing activities was $0.02 million from the sale of ordinary shares in VericiDx investment .

During the three months ended September 30, 2023, no cash was provided by or used in investing activities.

During the three months ended September 30, 2024, no cash was provided by or used in financing activities.

During the three months ended September 30, 2023, net cash used in financing activities was $1.1 million and was primarily attributable to $1.0 million in cash used to pay down the principal of the Bonds.

See Note 3 to our consolidated financial statements found elsewhere in this report for a description of recent accounting pronouncements applicable to our financial statements.

In April 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, for complying with new or revised accounting standards. An emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the extended transition period for complying with new or revised accounting standards and, as a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.

We have evaluated the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an emerging growth company, we have chosen to rely on certain of these exemptions, including without limitation exemptions to the requirements for (1) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (2) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier to occur of (a) the last day of the fiscal year (1) following the fifth anniversary of the completion of our U.S. IPO, (2) in which we have total annual gross revenues of at least $1.235 billion or (3) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means the market value of our ordinary shares and ADSs that are held by non-affiliates exceeds $700.0 million as of the prior December 31, or (b) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and share-based compensation. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in more detail in Note 3 to our consolidated financial statements included elsewhere in this report, we believe the following accounting policies are the most critical to the judgments and estimates used in the preparation of our consolidated financial statements.

Research and development expenses consist primarily of costs incurred in connection with the development of the KidneyIntelX technology platform. We expense research and development costs as incurred.

At the end of the reporting period, we compare payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that we estimate has been made as a result of the service provided, we may record a prepaid expense or accrued liability relating to these costs. Upfront milestone payments made to third parties who perform research and development services on our behalf are expensed as services are rendered. Contingent development or regulatory milestone payments are recognized upon the related resolution of such contingencies.

We make estimates of our accrued expenses as of each consolidated balance sheet date in our consolidated financial statements based on facts and circumstances known at that time. If the actual timing of the performance of services or the level of effort varies from the estimate, we will adjust the accrual accordingly. Nonrefundable advance payments for goods and services, including fees for process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as expense in the period that the related goods are consumed or services are performed.

We measure equity classified share-based awards granted to employees and nonemployees based on the estimated fair value on the date of grant and recognize compensation expense of those awards over the requisite service period, which is the vesting period of the respective award. We account for forfeitures as they occur. For share-based awards with service-based vesting conditions, we recognize compensation expense on a straight-line basis over the service period. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option, and our expected dividend yield. We were a privately-held organization prior to November 2018 and have been a publicly-traded company for a limited period of time and therefore lack company-specific historical and implied volatility information for our shares. Accordingly, we estimate our expected share price volatility based on the historical volatility of publicly-traded peer companies and expect to continue to do so until such time as we have adequate historical data regarding the volatility of our own traded share price. The expected term of our stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is none based on the fact that we have never paid cash dividends on ordinary shares and do not expect to pay any cash dividends in the foreseeable future.

We classify share-based compensation expense in our consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.

In April 2022, we issued amortizing senior convertible bonds with a principal amount of $21.2 million in amortizing senior convertible bonds due in April 2027 (the “Bonds”) to CVI Investments, Inc. (the “Convertible Bond Investor”). The Bonds were issued at 85% par value with total net proceeds of $18.0 million and accrue interest at an annual rate of 5.5%, payable quarterly in arrears, in cash or ADSs valued at the ADS Settlement Price at our option. The principal and interest payments are due in equal quarterly installments starting in July 2022. The Bonds contain various conversion and redemption features. The initial conversion price for the Convertible Bonds of $8.70 has been set at a 20 percent premium to the Reference ADS Price. The Conversion Price may reset down at 12, 24 and 36 months, depending on share price performance, the Bonds have a hard floor in the conversion price of $7.25. As a result of the February 2023 private placement and pursuant to conditions of the bond agreement, the conversion price was adjusted to $8.2508 (previously $8.70) and the floor price was adjusted to $6.8757 (previously $7.25). Further, pursuant to conditions of the agreement, effective April 7, 2023, the conversion price was adjusted from $8.2508 to $7.7924. Between amortization dates, Convertible Bond Investor retains the right to advance future amortization payments, provided that (a) there shall be no amortization advancements during the first 12 months, (b) no more than two amortization advancements may occur in any 12-month period, and (c) no more than one amortization advancement may occur in any 3-month period. On March 28, 2024, the Company entered into a second amendment and restatement agreement with the Convertible Bond Investor, which amended the terms of the Company’s existing bond agreement, dated March 31, 2022. The Company performed an analysis and determined that the financial impact was immaterial as the amended and restated agreement was not substantially different than the previous agreement.

The Convertible Bond Investor is also permitted to defer up to two amortization payments to a subsequent amortization date. We retain the option to repay any deferred amortization in cash at 100 percent of the nominal amount. In July 2022, we made a cash amortization payment of $1.4 million, which consisted of $1.1 million of principal and $0.3 million of interest. In October 2022, the Convertible Bond Investor deferred the October amortization payment to maturity of the bond and we made an interest payment of $0.3 million. In January 2023, we made a cash amortization payment of $1.4 million, which consisted of $1.1 million of principal and $0.3 million of interest. In April 2023, we made a cash amortization payment of $1.4 million, which consisted of $1.1 million of principal and $0.3 million of interest. In July 2023, we made a cash amortization payment of $1.4 million, which consisted of $1.1 million of principal and $0.3 million of interest. Also in July 2023, the Convertible Bond Investor exercised its right to advance an amortization payment and we made an accelerated repayment of $1.1 million through the issuance of 526,211 ADSs representing 1,052,422 ordinary shares. In October 2023, we made an amortization payment of $1.3 million, which consisted of $1.1 million of principal and $0.2 million of interest, through the issuance of 2,335,388 ordinary shares in the form of 150,000 ordinary shares and 1,092,694 ADSs. In December 2023, we made an amortization payment of $1.3 million, which consisted of $1.1 million of principal and $0.2 million of interest, through the issuance of 2,500,000 ordinary shares and a cash payment of $0.6 million. In April 2024, we issued 3,636,162 ordinary shares in the form of 1,818,081 ADSs to the Convertible Bond Investor, which settled the principal and interest amounts due under the bonds on April 7, 2024. In July 2024, we made an amortization payment of $1.3 million, which consisted of $1.1 million of principal and $0.2 million of interest, through the issuance of 11,557,322 ordinary shares in the form of 2,275,000 ordinary shares and 4,641,161 ADSs. As of September 30, 2024, $11.7 million of principal was outstanding. The securities were issued without registration in reliance upon the exemption provided in Section 3(a)(9) of the Securities Act.

The Bond Agreement contains a negative pledge covenant that provides that for so long as the principal amount outstanding under the Bonds is equal to or exceeds U.S. $3,000,000, the Company shall not, and will procure that none of its subsidiaries, will, create or permit to subsist any Security Interest (as defined in the Bond Agreement), other than a Permitted Security Interest (as defined in the Bond Agreement), upon the whole or any part of its present or future undertaking, assets or revenues (including any uncalled capital) to secure any Financial Indebtedness (as defined in the Bond Agreement) or to secure any Financial Indebtedness Guarantee (as defined in the Bond Agreement), without at the same time or prior thereto securing the obligations of the Company under the Bonds and the Bond Agreement equally and ratably therewith or providing such other security, guarantees and/or other arrangements for the benefit of holders of the Bonds as may be approved by all of the holders of the Bonds. The Bond Agreement also contains a covenant regarding the incurrence of indebtedness which provides that for so long as the principal amount outstanding under the Bonds is equal to or exceeds U.S. $5,000,000, the Company shall not, and shall procure that its subsidiaries shall not, at any time permit to create, incur, assume or otherwise become liable in respect of any Financial Indebtedness, contingently or otherwise. The Bond also contains negative covenants regarding, among other things, the issuance or paying up any securities, modifying the rights attaching to the ordinary shares; issuing any share capital with rights which are more favorable than the rights attaching to the ordinary shares; modify securities already issued, or grant securities, below a consideration floor; grant or issue securities that could not be legally issued as fully paid; not reduce its share capital, share premium account, or any uncalled liability in respect thereof, or any non-distributable reserves; certain third party offers made to shareholders; and ADSs and the ADS facility.

We elected the fair value option to account for the bonds as we believe the fair value option provides users of the consolidated financial statements with greater ability to estimate the outcome of future events as facts and circumstances change, particularly with respect to changes in the fair value of the ordinary shares underlying the conversion option. The fair value of the Notes is determined using a scenario-based analysis that estimates the fair value based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes available to the noteholders. For each reporting period, changes in the fair value of the notes are recognized through other income (expense) with the portion of the change that results from a change in the instrument-specific credit risk recorded separately in OCI for each reporting period.

On September 30, 2024, we announced a restructuring of these bonds. For more information, see “- Liquidity and Capital Resources – November 2024 Debt Restructurings” above.

We are a smaller reporting company and not required to provide this information.

We maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated to management, including our Chief Executive Officer (principal executive officer) and Interim Chief Financial Officer (principal financial officer), as appropriate, to allow timely decisions regarding required disclosure.

Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) as of September 30, 2024, have concluded that, as of such date, our disclosure controls and procedures were effective as described further below.

It should be noted that any system of controls is based in part upon certain assumptions designed to obtain reasonable (and not absolute) assurance as to its effectiveness, and there can be no assurance that any design will succeed in achieving its stated goals.

Management does not expect that our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control systems are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in a cost-effective control system, no evaluation of internal control over financial reporting can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been or will be detected.

In connection with the preparation of our consolidated financial statements for the year ended June 30, 2024, we concluded that there was a material weakness in the design of our internal control over financial reporting impacting accounting for the mark-to-market adjustment for convertible debt. A material weakness is a significant deficiency, or a combination of significant deficiencies, in internal control over financial reporting such that it is reasonably possible that a material misstatement of the annual or interim consolidated financial statements will not be prevented or detected on a timely basis. The material weakness was related to an error in the mark-to-market adjustment to our convertible debt that had been elected under the fair value option, which resulted in insufficient expense recognition. The deficiency arose due to the high complexity and technical nature of the convertible debt instrument and due to the lack of technical expertise. This material weakness resulted in adjustments to expense and equity which were recorded prior to the issuance of the consolidated financial statements as of June 30, 2024.

During the three months ended September 30, 2024, we executed our remediation plan by engaging a third-party advisory firm to help navigate the complexity of the convertible debt. We have also implemented controls to include senior management review of the transactions. These efforts ensure that our financial records are managed appropriately but also help ensure that the appropriate level of review is performed. We have concluded that the applicable remediated controls are designed, implemented and operating effectively.

As a result of these remediation activities we concluded the previously reported material weakness have been remediated as of September 30, 2024.

Besides the remediation of the previously disclosed material weakness in the design of our internal control over financial reporting impacting accounting for the mark-to-market adjustment for convertible debt, there have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently subject to any material legal proceedings.

In addition to the other information set forth in this Quarterly Report, you should carefully consider the risk factors and other cautionary statements described under the heading “Item 1A. Risk Factors” included in our 2024 Annual Report on Form 10-K and the risk factors and other cautionary statements contained in our other SEC filings, which could materially affect our business, financial condition or future results. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results.

Our future capital needs are uncertain, and our independent registered public accounting firm has expressed in its report on our audited financial statements for the fiscal year ended June 30, 2024 a substantial doubt about our ability to continue as a going concern. If our ability to continue as a going concern is dependent on our ability to raise additional capital, our operations could be curtailed if we are unable to obtain the required additional funding when needed. We may not be able to do so when necessary, and/or the terms of any financings may not be advantageous to us.

Our financial statements included in this report have been prepared assuming we will continue to operate as a going concern. However, due to our recurring losses from operations, and working capital deficiency, there is substantial doubt about our ability to continue as a going concern. Because we expect to continue to experience negative cash flow, our ability to continue as a going concern is subject to our ability to obtain necessary funding from outside sources, including obtaining additional funding from offerings of our equity securities or debt, transactions involving product development, licensing or collaboration, or other forms of financing. Management intends to continue its efforts to contain costs and to raise additional capital until we can generate sufficient cash from commercial sales to support operations, if ever. If we are unable to obtain sufficient financing, we may be required to delay, scale back or discontinue one or more product development programs, curtail our commercialization activities and significantly reduce expenses or we may not be able to continue as a going concern. As a result, our independent registered public accounting firm has expressed in its auditors’ report on the financial statements included in our Annual Report on Form 10-K a substantial doubt regarding our ability to continue as a going concern. Our financial statements in our Annual Report on Form 10-K and in this report do not include any adjustments that might result from the outcome of the uncertainty regarding our ability to continue as a going concern. If we cannot continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements, and our shareholders may lose their entire investment in our securities. Further, the perception that we may be unable to continue as a going concern may impede our ability to pursue strategic opportunities or operate our business due to concerns regarding our ability to discharge our contractual obligations. Future reports from our independent registered public accounting firm may also contain statements expressing doubt about our ability to continue as a going concern.

Subsequent to September 30, 2024, we raised an additional $14.9 million, net of expenses, to fund the operations of the company going forward. While the company plans to operate the business well beyond 12 months with this capital, there can be no guarantees that we will be successful in those plans. We have based our estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect or may fail in our efforts to enact additional cost reduction options. Furthermore, our operating plan may change, and we may need additional funds sooner than planned in order to meet operational needs and capital requirements for product development and commercialization.

Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchase of Equity Securities

Recent Sales of Unregistered Equity Securities.

During the quarter ended September 30, 2024, none of our directors or officers (as defined in Section 16 of the Securities Exchange Act of 1934, as amended) adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” (each as defined in Item 408(a) and (c) of Regulation S-K).

** Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


England and Wales	Not Applicable
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
2 Leman Street London, United Kingdom	E1W 9US
(Address of principal executive offices)	(Zip Code)


		ページ

パートI
項目 1.	連結財務諸表（未監査）	1
	2024年9月30日時点の連結財務諸表（未監査）および2024年6月30日時点の連結財務諸表	1
	2024年9月30日および2023年9月30日までの3か月間に終了した連結損益計算書および包括損益計算書 (未監査)	2
	2024年9月30日および2023年9月30日までの3か月間に終了した連結株主資本（赤字）計算書（未監査）	3
	2024年9月30日および2023年の第3四半期決算に基づくキャッシュ・フロー計算書（未検査）	4
	財務諸表注記（未監査）	5
アイテム2。	経営陣による財務状況と業績に関する会話と分析	22
アイテム3。	市場リスクに関する数量的および質的な開示	33
アイテム4.	内部統制および手順	33

第2部
項目 1.	法的措置	35
項目1A。	リスクファクター	35
アイテム2。	未登録の資本増加株式販売	36
アイテム3。	優先有価証券に対する債務不履行	36
アイテム4.	鉱山安全開示	36
項目5。	その他の情報	36
項目6。	展示物	37


（単位:千, 株式および１株あたりのデータを除く）	2024年9月30日			2024年6月30日
資産
流動資産:
現金及び現金同等物	$	909		$	4,680
売掛金（純額）		902			722
前払費用及びその他の流動資産		1,068			716
流動資産合計		2,879			6,118
有形固定資産		202			216
VericiDxへの投資		776			698
その他の資産		937			940
総資産	$	4,794		$	7,972

負債と株主資本赤字
流動負債：
支払い予定の勘定	$	3,188		$	1,590
関係会社向けの口座債務		2,408			1,018
未払費用およびその他の流動負債		2,162			3,354
未払費用 - 関連会社		102			1,329
現在のリース債務		11			45
ワラント債 - 現在		4,142			4,159
合計流動負債		12,013			11,495
ワラント債 - 非現在		4,100			4,331
総負債		16,113			15,826

コミットメント及び事態に関する注記（注10）

株主資本不足：
普通株式、£0.0025 一株あたりの額面価値: 173,841,695株式発行可能; 165,925,513および 154,368,191 株発行、および 2024年9月30日および2024年6月30日時点での未収金		515			478
追加出資資本		206,705			204,893
その他の総合損失		(2,029	)		(1,443	)
累積欠損		(216,510	)		(211,782	)
株主資本の欠損総額		(11,319	)		(7,854	)
負債総額と株主資本の欠損額合計	$	4,794		$	7,972


	2021 年 9 月 30 日までの 3 か月間
（単位:千, 株式および１株あたりのデータを除く）	2024			2023
収益	$	522		$	459
収益原価		422			502
粗利益（損失）		100			(43	)
営業費用:
研究開発		921			2,787
一般管理費		3,271			6,059
総営業費用		4,192			8,846
営業損失		(4,093	)		(8,889	)

外国為替の利益、純額		37			289
VericiDx投資の公正価値調整		97			(447	)
転換社債の公正価値調整		(762	)		(1,207	)
その他 (費用) 収入, 正味		(5	)		100
所得税前の純損失		(4,726	)		(10,154	)
法人税費用		(2	)		—
純損失		(4,728	)		(10,154	)

普通株あたりの純損失—基本	$	(0.04	)	$	(0.11	)
普通株あたりの純損失—希薄化後	$	(0.04	)	$	(0.11	)
加重平均普通株式—基本		105,697,401			94,767,841
加重平均普通株式—希薄化後		105,697,401			94,767,841

その他包括利益（損失）：
転換社債の公正価値の変動		(125	)		75
外国為替取引による換算差額		(461	)		42
包括損失	$	(5,314	)	$	(10,037	)


	普通株式				追加出資		累計その他の包括的			蓄積			合計株主資本（赤字）
(千単位、シェアおよびデータあたりを除く)	株式		金額		資本		損失			赤字			赤字
2024年7月1日の残高		154,368,191	$	478	$	204,893	$	(1,443	)	$	(211,782	)	$	(7,854	)
転換社債の返済のために発行されたシェア		11,557,322		37		1,551		—			—			1,588
シェアベースの報酬費用		—		—		254		—			—			254
その他の包括利益（損失）を通じて公正価値で測定される転換社債の公正価値の変動		—		—		—		(125	)		—			(125	)
為替差異による調整		—		—		7		(461	)		—			(454	)
純損失		—		—		—					(4,728	)		(4,728	)
2024年9月30日の残高		165,925,513	$	515	$	206,705	$	(2,029	)	$	(216,510	)	$	(11,319	)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO


	2021 年 9 月 30 日までの 3 か月間
(千単位)	2024			2023
営業活動によるキャッシュフロー:
純損失	$	(4,728	)	$	(10,154	)
営業活動からの純キャッシュ流入に調整するための調整：
減価償却および償却		60			127
株式ベースの報酬		254			523
VericiDx投資の公正価値調整		(97	)		447
VericiDxの普通株式の売却による実現損失		42			—
実現した外国為替の利益		(18	)		—
転換社債の公正価値調整、支払利息		762			945
現金以外のリース費用		—			28
貸倒引当金		(25	)		—
営業資産および負債の変動:
売掛金		(154	)		(238	)
前払費用及びその他の流動資産		(327	)		(153	)
支払い予定の勘定		1,550			250
関係会社向けの口座債務		1,390			202
未払費用およびその他の流動負債		(1,312	)		(2,060	)
未払費用 - 関連会社		(1,233	)		579
営業によるキャッシュフローの純流出		(3,836	)		(9,504	)

投資活動によるキャッシュフロー：
VericiDx投資における普通株式の売却		23			—
投資活動からの純現金流入		23			—

財務活動からのキャッシュフロー:
転換社債の元本の支払い		—			(1,060	)
奉仕費用の支払い		—			(5	)
財務活動による正味キャッシュ流出		—			(1,065	)
為替レート変化のキャッシュへの影響		42			(222	)
現金及び現金同等物の純減少分		(3,771	)		(10,791	)
現金及び現金同等物期首残高		4,680			24,682
期末現金及び現金同等物	$	909		$	13,891
その他の非現金投資および融資活動:
使用権資産の取得に伴う非現金リース負債	$	—		$	4
転換社債に対する利息の支払い	$	—		$	249
債務返済のための株式発行	$	(1,588	)	$	(1,054	)


	For the Three Months Ended September 30,						Change 2024 vs.2023
(in thousands, except share and per share data)	2024			2023			Change			%
Revenue	$	522		$	459		$	63			14	%
Cost of revenue		422			502			(80	)		-16	%
Gross profit (loss)		100			(43	)		143			-332	%
Operating expenses:
Research and development		921			2,787			(1,866	)		-67	%
General and administrative		3,271			6,059			(2,788	)		-46	%
Total operating expenses		4,192			8,846			(4,654	)		-53	%
Loss from operations		(4,093	)		(8,889	)		4,796			-54	%

Foreign currency gain, net		37			289			(252	)		-87	%
Fair value adjustment to VericiDx investment		97			(447	)		544			-122	%
Fair value adjustment to convertible notes		(762	)		(1,207	)		445			-37	%
Other (expense) income, net		(5	)		100			(105	)		-105	%
Net loss before income taxes		(4,726	)		(10,154	)		5,428			-53	%
Income tax expense		(2	)		—			(2	)	-
Net loss		(4,728	)		(10,154	)		5,426			-53	%

Net loss per ordinary share—basic	$	(0.04	)	$	(0.11	)	$	0.06			-58	%
Net loss per ordinary share—diluted	$	(0.04	)	$	(0.11	)	$	0.06			-58	%
Weighted average ordinary shares—basic		105,697,401			94,767,841			10,929,560			12	%
Weighted average ordinary shares—diluted		105,697,401			94,767,841			10,929,560			12	%

Other comprehensive income (loss):
Changes in the fair value of the convertible notes		(125	)		75			(200	)		-267	%
Foreign exchange translation adjustment		(461	)		42			(503	)		-1198	%
Comprehensive loss	$	(5,314	)	$	(10,037	)	$	4,723			-47	%


	For the Three Months Ended September 30,				Change 2024 vs. 2023
(in thousands)	2024		2023		Change		%
Revenue	$	522	$	459	$	63		14	%


		Incorporation by Reference
Exhibit No.	Description	Schedule/ Form	File Number	Exhibit	File Date

3.1	Articles of Association	10-Q	001-39387	3.1	2/14/2024
4.1	Reference is made to Exhibit 3.1
4.2	Form of Deposit Agreement	F-1/A	333-239414	4.1	7/13/2020
4.3	Form of American Depositary Receipt (included in Exhibit 4.2)	F-1/A	333-239414	4.1	7/13/2020
4.4	Description of Securities	20-F	001-39387	4.3	10/28/2020
10.1	Placing Agreement dated October 1, 2024	8-K	001-39387	10.1	10/1/2024
10.2	Form of Subscription Agreement	8-K	001-39387	10.2	10/1/2024
31.1*	Certification of Chief Executive Officer pursuant to Securities Exchange Act of 1934 Rule 13a-14(a) or 15d-14a
31.2*	Certification of Chief Financial Officer pursuant to Securities Exchange Act of 1934 Rule 13a-14(a) or 15d-14a
32.1**	Certification by the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS*	Inline XBRL Instance Document
101.SCH*	Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents
104	Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)


	RENALYTIX PLC

November 19, 2024	By:	/s/ James McCullough
	Name:	James McCullough
	Title:	Chief Executive Officer


	RENALYTIX PLC

November 19, 2024	By:	/s/ Joel R. Jung
	Name:	Joel R. Jung
	Title:	Interim Chief Financial Officer (Principal Financial Officer)