[8-K] Beta Bionics, Inc. Reports Material Event
Beta Bionics, Inc. (Nasdaq: BBNX) filed an 8-K to disclose materials from its first Investor & Analyst Event held on 22 June 2025 in conjunction with the ADA Scientific Sessions. Exhibit 99.1 contains a detailed slide deck highlighting two-year, real-world performance of the iLet Bionic Pancreas.
The company analysed data from 16,439 commercial users who uploaded ≥3 weeks of CGM readings between 19 May 2023 and 18 May 2025. A core cohort of 14,952 users with baseline HbA1c records showed an average HbA1c reduction from 8.9 % to a GMI of 7.3 %. Across multiple sub-groups—MDI converts (8,802 users), competitive HCL converts (2,910 users), endocrinology vs. primary-care settings, and “fully-closed loop” users—similar improvements were observed, with ≥83 % of patients meeting ADA hypoglycaemia targets (<4 % time <70 mg/dL; <1 % time <54 mg/dL).
Algorithmic performance data from 30,077 device sessions indicate the system reaches a steady-state GMI of 7.4 % within two days of initiation, underscoring rapid optimisation.
Management emphasises the potential clinical benefit of iLet but cautions that the forward-looking statements are subject to regulatory, financing and market risks. No financial metrics, revenue guidance or earnings updates were provided, and the furnished information is not deemed “filed” under the Exchange Act.
Beta Bionics, Inc. (Nasdaq: BBNX) ha presentato un modulo 8-K per divulgare i materiali del suo primo Investor & Analyst Event, tenutosi il 22 giugno 2025 in concomitanza con le ADA Scientific Sessions. L'Esibizione 99.1 contiene una dettagliata presentazione che evidenzia le prestazioni reali biennali del iLet Bionic Pancreas.
L'azienda ha analizzato i dati di 16.439 utenti commerciali che hanno caricato almeno 3 settimane di letture CGM tra il 19 maggio 2023 e il 18 maggio 2025. Un nucleo centrale di 14.952 utenti con registrazioni basali di HbA1c ha mostrato una riduzione media di HbA1c dall'8,9% a un GMI del 7,3%. In diversi sottogruppi — convertiti da MDI (8.802 utenti), convertiti da HCL competitivi (2.910 utenti), ambienti endocrinologici vs. cure primarie, e utenti in “loop completamente chiuso” — sono stati osservati miglioramenti simili, con almeno l'83% dei pazienti che ha raggiunto gli obiettivi ADA per l'ipoglicemia (<4% del tempo <70 mg/dL; <1% del tempo <54 mg/dL).
I dati sulle prestazioni algoritmiche provenienti da 30.077 sessioni del dispositivo indicano che il sistema raggiunge un GMI stabile del 7,4% entro due giorni dall'avvio, evidenziando una rapida ottimizzazione.
La direzione sottolinea il potenziale beneficio clinico di iLet ma avverte che le dichiarazioni previsionali sono soggette a rischi regolatori, finanziari e di mercato. Non sono stati forniti dati finanziari, previsioni di ricavi o aggiornamenti sugli utili, e le informazioni fornite non sono considerate "depositate" ai sensi dell'Exchange Act.
Beta Bionics, Inc. (Nasdaq: BBNX) presentó un formulario 8-K para divulgar materiales de su primer Investor & Analyst Event celebrado el 22 de junio de 2025 junto con las ADA Scientific Sessions. El Anexo 99.1 contiene una presentación detallada que destaca el desempeño en el mundo real durante dos años del iLet Bionic Pancreas.
La compañía analizó datos de 16,439 usuarios comerciales que subieron al menos 3 semanas de lecturas CGM entre el 19 de mayo de 2023 y el 18 de mayo de 2025. Un grupo central de 14,952 usuarios con registros basales de HbA1c mostró una reducción promedio de HbA1c del 8.9% a un GMI de 7.3%. En varios subgrupos — convertidos de MDI (8,802 usuarios), convertidos de HCL competitivos (2,910 usuarios), entornos endocrinológicos vs. atención primaria, y usuarios en “bucle completamente cerrado” — se observaron mejoras similares, con al menos el 83% de los pacientes alcanzando los objetivos de hipoglucemia de ADA (<4% del tiempo <70 mg/dL; <1% del tiempo <54 mg/dL).
Los datos de rendimiento algorítmico de 30,077 sesiones del dispositivo indican que el sistema alcanza un GMI estable del 7.4% dentro de dos días desde el inicio, destacando una rápida optimización.
La dirección enfatiza el potencial beneficio clínico de iLet, pero advierte que las declaraciones prospectivas están sujetas a riesgos regulatorios, financieros y de mercado. No se proporcionaron métricas financieras, pronósticos de ingresos ni actualizaciones de ganancias, y la información proporcionada no se considera "presentada" bajo la Exchange Act.
Beta Bionics, Inc. (나스닥: BBNX)는 2025년 6월 22일 ADA Scientific Sessions와 함께 개최된 첫 투자자 및 애널리스트 이벤트 자료를 공개하기 위해 8-K 보고서를 제출했습니다. 전시물 99.1에는 iLet Bionic Pancreas의 2년간 실제 성능을 강조한 상세 슬라이드가 포함되어 있습니다.
회사는 2023년 5월 19일부터 2025년 5월 18일 사이에 3주 이상 CGM 데이터를 업로드한 16,439명의 상업 사용자 데이터를 분석했습니다. 기저 HbA1c 기록이 있는 14,952명의 핵심 집단에서 평균 HbA1c가 8.9%에서 GMI 7.3%로 감소한 것으로 나타났습니다. MDI 전환자(8,802명), 경쟁 HCL 전환자(2,910명), 내분비과 대 1차 진료 환경, ‘완전 폐쇄 루프’ 사용자 등 여러 하위 그룹에서 유사한 개선이 관찰되었으며, 환자의 ≥83%가 ADA 저혈당 목표(<4% 시간 <70 mg/dL; <1% 시간 <54 mg/dL)를 충족했습니다.
30,077회 기기 세션의 알고리즘 성능 데이터는 시스템이 시작 후 2일 이내에 안정적인 GMI 7.4%에 도달함을 보여 빠른 최적화를 입증합니다.
경영진은 iLet의 잠재적 임상 이점을 강조하면서도, 미래 예측 진술은 규제, 자금 조달 및 시장 위험에 영향을 받을 수 있음을 경고했습니다. 재무 지표, 수익 전망 또는 실적 업데이트는 제공되지 않았으며, 제출된 정보는 Exchange Act에 따라 "제출된" 것으로 간주되지 않습니다.
Beta Bionics, Inc. (Nasdaq : BBNX) a déposé un formulaire 8-K pour divulguer les documents de son premier Investor & Analyst Event, tenu le 22 juin 2025 lors des ADA Scientific Sessions. L'Exhibit 99.1 contient une présentation détaillée mettant en lumière la performance en conditions réelles sur deux ans du iLet Bionic Pancreas.
L'entreprise a analysé les données de 16 439 utilisateurs commerciaux ayant téléchargé au moins 3 semaines de relevés CGM entre le 19 mai 2023 et le 18 mai 2025. Une cohorte principale de 14 952 utilisateurs avec des enregistrements HbA1c de base a montré une réduction moyenne de l'HbA1c de 8,9 % à un GMI de 7,3 %. Dans plusieurs sous-groupes — convertis de MDI (8 802 utilisateurs), convertis de HCL concurrentiels (2 910 utilisateurs), milieux endocrinologiques vs soins primaires, et utilisateurs en « boucle fermée complète » — des améliorations similaires ont été observées, avec ≥83 % des patients atteignant les objectifs ADA en matière d'hypoglycémie (<4 % du temps <70 mg/dL ; <1 % du temps <54 mg/dL).
Les données de performance algorithmique issues de 30 077 sessions de dispositifs indiquent que le système atteint un GMI stable de 7,4 % en deux jours après le démarrage, soulignant une optimisation rapide.
La direction souligne le bénéfice clinique potentiel de l'iLet mais avertit que les déclarations prospectives sont soumises à des risques réglementaires, financiers et de marché. Aucune donnée financière, prévision de revenus ou mise à jour des résultats n'a été fournie, et les informations fournies ne sont pas considérées comme "déposées" au titre de l'Exchange Act.
Beta Bionics, Inc. (Nasdaq: BBNX) reichte ein 8-K ein, um Materialien von seiner ersten Investor & Analyst Veranstaltung am 22. Juni 2025 im Rahmen der ADA Scientific Sessions offenzulegen. Exhibit 99.1 enthält eine detaillierte Präsentation, die die zweijährige, reale Leistung des iLet Bionic Pancreas hervorhebt.
Das Unternehmen analysierte Daten von 16.439 kommerziellen Nutzern, die zwischen dem 19. Mai 2023 und dem 18. Mai 2025 mindestens 3 Wochen CGM-Daten hochgeladen hatten. Eine Kernkohorte von 14.952 Nutzern mit Baseline-HbA1c-Werten zeigte eine durchschnittliche HbA1c-Reduktion von 8,9 % auf einen GMI von 7,3 %. In mehreren Untergruppen — MDI-Konvertierte (8.802 Nutzer), Wettbewerbs-HCL-Konvertierte (2.910 Nutzer), Endokrinologie vs. Primärversorgung und „vollständig geschlossene Schleifen“-Nutzer — wurden ähnliche Verbesserungen beobachtet, wobei ≥83 % der Patienten die ADA-Hypoglykämie-Ziele (<4 % Zeit <70 mg/dL; <1 % Zeit <54 mg/dL) erreichten.
Algorithmische Leistungsdaten aus 30.077 Gerätesitzungen zeigen, dass das System innerhalb von zwei Tagen nach Beginn einen stabilen GMI von 7,4 % erreicht, was eine schnelle Optimierung unterstreicht.
Das Management betont den potenziellen klinischen Nutzen von iLet, warnt jedoch, dass zukunftsgerichtete Aussagen regulatorischen, finanziellen und Marktrisiken unterliegen. Es wurden keine finanziellen Kennzahlen, Umsatzprognosen oder Gewinnupdates bereitgestellt, und die bereitgestellten Informationen gelten nicht als "eingereicht" im Sinne des Exchange Act.
- Meaningful HbA1c reduction: Average drop from 8.9 % to 7.3 % across 14,952 users suggests strong efficacy in real-world settings.
- Large user base: 16,439 commercial users analysed within two years of launch signals accelerating adoption.
- Safety profile: ≥83 % of users met ADA hypoglycaemia targets, reinforcing device safety claims.
- Competitive conversions: Prior users of rival hybrid-closed loop systems also benefited, indicating potential market share gains.
- Rapid algorithm stabilisation: Steady-state GMI achieved in two days supports ease-of-use messaging.
- No financial metrics disclosed: Filing lacks revenue, margin or guidance, limiting insight into economic impact.
- Observational data limitations: Retrospective, uncontrolled design introduces potential selection and reporting biases.
- Forward-looking risk factors: Management cites regulatory, financing and market uncertainties that could impair future results.
Insights
TL;DR: Large real-world dataset confirms iLet efficacy, signalling competitive strength and commercial traction.
The disclosure provides clinically meaningful, population-scale evidence that iLet reduces average HbA1c by ~1.6 percentage points and maintains strong hypoglycaemia safety across 16k users—a persuasive validation beyond controlled trials. Improvement appears consistent among prior MDI and rival HCL users, suggesting market share capture potential from established competitors (Tandem, Insulet, Medtronic). Rapid two-day algorithm stabilisation supports ease-of-use claims, an important differentiator. While absent of revenue figures, the scale of post-launch usage implies healthy adoption. Overall, the dataset materially strengthens the product’s value proposition and could accelerate payer coverage and prescriber uptake.
TL;DR: Positive clinical data, but observational design limits certainty; no financials disclosed.
The results are encouraging, yet they stem from retrospective uploads without a control arm, raising potential selection bias. Outcomes rely on patient-reported or provider-submitted baselines, and only 91 % had HbA1c data. Forward-looking statements highlight financing and regulatory uncertainties, reminding investors that clinical success does not guarantee commercial profitability. Lack of revenue, margin or guidance keeps valuation impact speculative. Nonetheless, risk is moderated by the sizeable sample and consistency across cohorts.
Beta Bionics, Inc. (Nasdaq: BBNX) ha presentato un modulo 8-K per divulgare i materiali del suo primo Investor & Analyst Event, tenutosi il 22 giugno 2025 in concomitanza con le ADA Scientific Sessions. L'Esibizione 99.1 contiene una dettagliata presentazione che evidenzia le prestazioni reali biennali del iLet Bionic Pancreas.
L'azienda ha analizzato i dati di 16.439 utenti commerciali che hanno caricato almeno 3 settimane di letture CGM tra il 19 maggio 2023 e il 18 maggio 2025. Un nucleo centrale di 14.952 utenti con registrazioni basali di HbA1c ha mostrato una riduzione media di HbA1c dall'8,9% a un GMI del 7,3%. In diversi sottogruppi — convertiti da MDI (8.802 utenti), convertiti da HCL competitivi (2.910 utenti), ambienti endocrinologici vs. cure primarie, e utenti in “loop completamente chiuso” — sono stati osservati miglioramenti simili, con almeno l'83% dei pazienti che ha raggiunto gli obiettivi ADA per l'ipoglicemia (<4% del tempo <70 mg/dL; <1% del tempo <54 mg/dL).
I dati sulle prestazioni algoritmiche provenienti da 30.077 sessioni del dispositivo indicano che il sistema raggiunge un GMI stabile del 7,4% entro due giorni dall'avvio, evidenziando una rapida ottimizzazione.
La direzione sottolinea il potenziale beneficio clinico di iLet ma avverte che le dichiarazioni previsionali sono soggette a rischi regolatori, finanziari e di mercato. Non sono stati forniti dati finanziari, previsioni di ricavi o aggiornamenti sugli utili, e le informazioni fornite non sono considerate "depositate" ai sensi dell'Exchange Act.
Beta Bionics, Inc. (Nasdaq: BBNX) presentó un formulario 8-K para divulgar materiales de su primer Investor & Analyst Event celebrado el 22 de junio de 2025 junto con las ADA Scientific Sessions. El Anexo 99.1 contiene una presentación detallada que destaca el desempeño en el mundo real durante dos años del iLet Bionic Pancreas.
La compañía analizó datos de 16,439 usuarios comerciales que subieron al menos 3 semanas de lecturas CGM entre el 19 de mayo de 2023 y el 18 de mayo de 2025. Un grupo central de 14,952 usuarios con registros basales de HbA1c mostró una reducción promedio de HbA1c del 8.9% a un GMI de 7.3%. En varios subgrupos — convertidos de MDI (8,802 usuarios), convertidos de HCL competitivos (2,910 usuarios), entornos endocrinológicos vs. atención primaria, y usuarios en “bucle completamente cerrado” — se observaron mejoras similares, con al menos el 83% de los pacientes alcanzando los objetivos de hipoglucemia de ADA (<4% del tiempo <70 mg/dL; <1% del tiempo <54 mg/dL).
Los datos de rendimiento algorítmico de 30,077 sesiones del dispositivo indican que el sistema alcanza un GMI estable del 7.4% dentro de dos días desde el inicio, destacando una rápida optimización.
La dirección enfatiza el potencial beneficio clínico de iLet, pero advierte que las declaraciones prospectivas están sujetas a riesgos regulatorios, financieros y de mercado. No se proporcionaron métricas financieras, pronósticos de ingresos ni actualizaciones de ganancias, y la información proporcionada no se considera "presentada" bajo la Exchange Act.
Beta Bionics, Inc. (나스닥: BBNX)는 2025년 6월 22일 ADA Scientific Sessions와 함께 개최된 첫 투자자 및 애널리스트 이벤트 자료를 공개하기 위해 8-K 보고서를 제출했습니다. 전시물 99.1에는 iLet Bionic Pancreas의 2년간 실제 성능을 강조한 상세 슬라이드가 포함되어 있습니다.
회사는 2023년 5월 19일부터 2025년 5월 18일 사이에 3주 이상 CGM 데이터를 업로드한 16,439명의 상업 사용자 데이터를 분석했습니다. 기저 HbA1c 기록이 있는 14,952명의 핵심 집단에서 평균 HbA1c가 8.9%에서 GMI 7.3%로 감소한 것으로 나타났습니다. MDI 전환자(8,802명), 경쟁 HCL 전환자(2,910명), 내분비과 대 1차 진료 환경, ‘완전 폐쇄 루프’ 사용자 등 여러 하위 그룹에서 유사한 개선이 관찰되었으며, 환자의 ≥83%가 ADA 저혈당 목표(<4% 시간 <70 mg/dL; <1% 시간 <54 mg/dL)를 충족했습니다.
30,077회 기기 세션의 알고리즘 성능 데이터는 시스템이 시작 후 2일 이내에 안정적인 GMI 7.4%에 도달함을 보여 빠른 최적화를 입증합니다.
경영진은 iLet의 잠재적 임상 이점을 강조하면서도, 미래 예측 진술은 규제, 자금 조달 및 시장 위험에 영향을 받을 수 있음을 경고했습니다. 재무 지표, 수익 전망 또는 실적 업데이트는 제공되지 않았으며, 제출된 정보는 Exchange Act에 따라 "제출된" 것으로 간주되지 않습니다.
Beta Bionics, Inc. (Nasdaq : BBNX) a déposé un formulaire 8-K pour divulguer les documents de son premier Investor & Analyst Event, tenu le 22 juin 2025 lors des ADA Scientific Sessions. L'Exhibit 99.1 contient une présentation détaillée mettant en lumière la performance en conditions réelles sur deux ans du iLet Bionic Pancreas.
L'entreprise a analysé les données de 16 439 utilisateurs commerciaux ayant téléchargé au moins 3 semaines de relevés CGM entre le 19 mai 2023 et le 18 mai 2025. Une cohorte principale de 14 952 utilisateurs avec des enregistrements HbA1c de base a montré une réduction moyenne de l'HbA1c de 8,9 % à un GMI de 7,3 %. Dans plusieurs sous-groupes — convertis de MDI (8 802 utilisateurs), convertis de HCL concurrentiels (2 910 utilisateurs), milieux endocrinologiques vs soins primaires, et utilisateurs en « boucle fermée complète » — des améliorations similaires ont été observées, avec ≥83 % des patients atteignant les objectifs ADA en matière d'hypoglycémie (<4 % du temps <70 mg/dL ; <1 % du temps <54 mg/dL).
Les données de performance algorithmique issues de 30 077 sessions de dispositifs indiquent que le système atteint un GMI stable de 7,4 % en deux jours après le démarrage, soulignant une optimisation rapide.
La direction souligne le bénéfice clinique potentiel de l'iLet mais avertit que les déclarations prospectives sont soumises à des risques réglementaires, financiers et de marché. Aucune donnée financière, prévision de revenus ou mise à jour des résultats n'a été fournie, et les informations fournies ne sont pas considérées comme "déposées" au titre de l'Exchange Act.
Beta Bionics, Inc. (Nasdaq: BBNX) reichte ein 8-K ein, um Materialien von seiner ersten Investor & Analyst Veranstaltung am 22. Juni 2025 im Rahmen der ADA Scientific Sessions offenzulegen. Exhibit 99.1 enthält eine detaillierte Präsentation, die die zweijährige, reale Leistung des iLet Bionic Pancreas hervorhebt.
Das Unternehmen analysierte Daten von 16.439 kommerziellen Nutzern, die zwischen dem 19. Mai 2023 und dem 18. Mai 2025 mindestens 3 Wochen CGM-Daten hochgeladen hatten. Eine Kernkohorte von 14.952 Nutzern mit Baseline-HbA1c-Werten zeigte eine durchschnittliche HbA1c-Reduktion von 8,9 % auf einen GMI von 7,3 %. In mehreren Untergruppen — MDI-Konvertierte (8.802 Nutzer), Wettbewerbs-HCL-Konvertierte (2.910 Nutzer), Endokrinologie vs. Primärversorgung und „vollständig geschlossene Schleifen“-Nutzer — wurden ähnliche Verbesserungen beobachtet, wobei ≥83 % der Patienten die ADA-Hypoglykämie-Ziele (<4 % Zeit <70 mg/dL; <1 % Zeit <54 mg/dL) erreichten.
Algorithmische Leistungsdaten aus 30.077 Gerätesitzungen zeigen, dass das System innerhalb von zwei Tagen nach Beginn einen stabilen GMI von 7,4 % erreicht, was eine schnelle Optimierung unterstreicht.
Das Management betont den potenziellen klinischen Nutzen von iLet, warnt jedoch, dass zukunftsgerichtete Aussagen regulatorischen, finanziellen und Marktrisiken unterliegen. Es wurden keine finanziellen Kennzahlen, Umsatzprognosen oder Gewinnupdates bereitgestellt, und die bereitgestellten Informationen gelten nicht als "eingereicht" im Sinne des Exchange Act.
UNITED STATES
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FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure
On June 22, 2025, Beta Bionics, Inc. (the “Company”) hosted its first Investor and Analyst Event in conjunction with the 85th Scientific Sessions of the American Diabetes Association (“ADA”). A copy of the presentation to be used by the Company during the event (the “Presentation”) is attached hereto as Exhibit 99.1 and incorporated by reference herein. A copy of the Presentation will also be available on the Company’s website in the “Investors – Events & Presentations” section at https://investors.betabionics.com. Information contained in, or that can be accessed through, the Company's website is not incorporated by reference into this report.
The information contained under this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, regardless of any general incorporation language in any such filing, unless the Company expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.
Item 8.01 Other Events
On June 22, 2025, the Company announced updated “Real-world” iLet Bionic Pancreas (“iLet”) data sourced from iLet users who uploaded continuous glucose monitor (“CGM”) readings to the Beta Bionics cloud over the first two years after the iLet’s commercial launch (May 19, 2023 to May 18, 2025). 16,439 iLet users uploaded at least three-weeks’ worth of iLet data. Of those 16,439 iLet users, 14,952 had a pre-iLet baseline HbA1c value available (as provided to us by the medical providers).
Figure 1 shows the change from baseline HbA1c to glucose management indicator (“GMI”) – a population-based estimate of HbA1c based on mean CGM glucose that is widely accepted as an indicator in the diabetes industry – on the iLet for the group of 14,952 iLet users. Data from these users showed an overall improvement from an average baseline HbA1c of 8.9% to an average GMI of 7.3% on the iLet. Users saw a meaningful change from baseline HbA1c to follow-up GMI on iLet regardless of their baseline HbA1c. Additionally, over 84% of these users met the ADA’s hypoglycemia goals of less than 4% time below 70 mg/dL and less than 1% time below 54 mg/dL.
Figure 1. All iLet Users: Change from Baseline HbA1c to Follow-Up GMI While On the iLet
Figure 2 shows the HbA1c of adults with Type 1 Diabetes (“T1D”) in the United States based on the real-world data included in Pettus et al., Diabetes Care 2019;42:2220–2227 (“Pettus study”). The Pettus study included data from 31,430 adults, sourced from the Optum Humedica database between July 2014 and June 2016. Figure 2 also shows the baseline HbA1c of 10,333 iLet users who are adults and have T1D (as provided to us by the medical providers). The 10,333 iLet users included in Figure 2 who are adults and have T1D are a subgroup of the aforementioned 14,952 iLet users.
Figure 2. HbA1c of Adults with T1D in the U.S. Versus Baseline HbA1c of iLet Adult Users with T1D
Figure 3 shows the HbA1c of adults with T1D in the United States based on the Pettus study. Figure 3 also shows the follow-up GMI on iLet of the same 10,333 iLet users who are adults and have T1D as described above.
Figure 3. HbA1c of Adults with T1D in the U.S. Versus Follow-Up GMI of iLet Adult Users with T1D
Figure 4 shows the change from baseline HbA1c to GMI on the iLet for iLet users whose previous therapy before starting iLet was multiple daily injections (“MDI”) (as provided to us by the medical providers). Of the aforementioned 14,952 iLet users, 8,802 iLet users were identified as using MDI as their most recent therapy prior to starting iLet. Data from these previous MDI users showed an overall improvement from an average baseline HbA1c of 9.2% to an average GMI of 7.3% on the iLet. Users saw a meaningful change from baseline HbA1c to follow-up GMI on iLet regardless of their baseline HbA1c. Additionally, over 85% of users met the ADA’s aforementioned hypoglycemia goals.
Figure 4. iLet Users Coming from MDI: Change from Baseline HbA1c to Follow-Up GMI While On the iLet
Figure 5 shows the change from baseline HbA1c to GMI on the iLet for iLet users whose previous therapy before starting iLet was a competitive hybrid-closed loop (“HCL”) system (as provided to us directly by users). Competitive HCL systems include Tandem’s t:slim X2 and Mobi, Insulet’s Omnipod 5, and Medtronic’s MiniMed 670G, 720G, 750G, 760G, 770G, and 780G. Of the aforementioned 14,952 iLet users, 2,910 iLet users were identified as using a competitive HCL system as their most recent therapy prior to starting iLet. Data from these previous competitive HCL system users showed an overall improvement from an average baseline HbA1c of 8.1% to an average GMI of 7.3% on the iLet. Users saw a meaningful change from baseline HbA1c to follow-up GMI on iLet regardless of their baseline HbA1c. Additionally, over 83% of users met the ADA’s aforementioned hypoglycemia goals.
Figure 5. iLet Users Coming from Competitive HCL Systems: Change from Baseline HbA1c to Follow-Up GMI While On the iLet
Figure 6 shows the change from baseline HbA1c to GMI on the iLet for iLet users who are treated in endocrinology practices and primary care practices (as determined by Symphony Health Solutions’ database and the Centers for Medicare & Medicaid Services’ National Plan and Provider Enumeration System). Of the aforementioned 14,952 iLet users, 13,566 iLet users were identified as being treated in endocrinology practices, and 1,036 iLet users were identified as being treated in primary care practices. Data from iLet users treated in endocrinology practices and users treated in primary care practices showed a similar overall improvement from an average baseline HbA1c of 8.9% to an average GMI of 7.3% on the iLet. Users saw a similar improvement from baseline HbA1c to follow-up GMI on iLet regardless of their provider practice type. Additionally, over 84% of users met the ADA’s aforementioned hypoglycemia goals regardless of their provider practice type.
Figure 6. iLet Users Treated by Type of Provider Practice (Endocrinology or Primary Care)
Figure 7 shows the change from baseline HbA1c to GMI on the iLet for iLet users who use the pump in a “fully-closed loop” manner, defined as iLet users who announced less than one meal per day, on average, over the 21-day period from April 28, 2025 to May 18, 2025 (as determined by meal announcements inputted into the iLet App). Of the aforementioned 14,952 iLet users, 2,416 iLet users were identified as using the pump in a “fully-closed loop” manner. On average, “fully-closed loop” iLet users announced approximately one meal every three days. Data from “fully-closed loop” iLet users showed an overall improvement from an average baseline HbA1c of 9.4% to an average GMI of 7.5% on the iLet during the 21-day period. Users saw a meaningful change from baseline HbA1c to follow-up GMI on iLet regardless of their baseline HbA1c, and approximately 83% of users met the ADA’s aforementioned hypoglycemia goals. Additionally, those users showed an average time in range (defined as blood glucose levels between 70 and 180 mg/dL as determined by CGM readings) of approximately 62%. Lastly, 530 iLet users were identified as not having announced a single meal in the aforementioned 21-day period, and those users showed an overall improvement from an average baseline HbA1c of 9.4% to an average GMI of 7.4% on the iLet during the 21-day period. Additionally, approximately 86% of those users met the ADA’s aforementioned hypoglycemia goals.
Figure 7. “Fully-Closed” Loop iLet Users: Change from Baseline HbA1c to Follow-Up GMI
While On the iLet
Figure 8 shows the change from baseline HbA1c to follow-up GMI on the iLet relative to the duration of iLet use from initialization to day 42. These data are sourced from all iLet users who uploaded CGM readings to the Beta Bionics cloud over the first two years after the iLet’s commercial launch (May 19, 2023 to May 18, 2025). 90% of these users had a baseline HbA1c available, but all users were included in the analysis regardless of whether or not they had a baseline HbA1c available. In total, 30,077 iLet sessions were uploaded. A session reflects each initial use of an iLet or after a factory reset. Most iLets had only one session. iLet sessions showed an overall improvement from an average baseline HbA1c of 8.9% to an average GMI of 7.4% on the iLet after 42 days. On average, the iLet sessions took two days to reach a near steady-state GMI of 7.4%, suggesting that the adaptive algorithm “warms-up” just two days after initiation.
Figure 8. Change from Baseline HbA1c to Follow-Up GMI On the iLet Relative to the Duration of iLet Use
Cautionary Statement Regarding Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this Current Report on Form 8-K that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding the potential benefits of the iLet, including the overall improvement reflected in the data between average baseline HbA1c and an average GMI on the iLet. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties, including business, regulatory, economic and competitive risks and uncertainties about the Company, including, without limitation, risks inherent in developing product candidates, future results from the Company’s ongoing and future studies and clinical trials, the Company’s ability to obtain adequate financing to fund its product development and other expenses, risks that real-world data or future results may not be consistent with interim, initial or preliminary results or results from prior preclinical studies or clinical trials, trends in the industry, the Company’s relationships with its existing and future collaboration partners, the legal and regulatory framework for the industry, future expenditures and the potential impacts of global macroeconomic conditions. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the variations may be material. Other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the Securities and Exchange Commission, including the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this Current Report on Form 8-K is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description |
| 99.1 | Investor and Analyst Event Presentation |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Beta Bionics, Inc. | ||
| By: | /s/ Sean Saint | |
| Sean Saint | ||
| President and Chief Executive Officer | ||
Dated: June 23, 2025
FAQ
What key clinical outcome did Beta Bionics (BBNX) report for the iLet?
How many iLet users were included in the real-world dataset?
Did former users of other hybrid-closed loop systems benefit from switching to iLet?
How quickly does the iLet algorithm stabilise after initiation?
Does the 8-K include any financial guidance or revenue information?
Is the provided information considered “filed” with the SEC?
