[424B5] Sagimet Biosciences Inc. Series A Prospectus Supplement (Debt Securities)
Sagimet Biosciences Inc. filed a prospectus supplement to offer up to $75.0 million of Series A common stock through an "at-the-market" sales agreement with Leerink Partners. The company’s Series A common stock trades on Nasdaq under the symbol SGMT and the last reported sale price referenced was $9.58 per share on August 13, 2025. Net proceeds are intended to advance development of denifanstat and other FASN inhibitors, for R&D, working capital and general corporate purposes.
The supplement highlights clinical progress: denifanstat met both primary and multiple secondary endpoints in a Phase 2b FASCINATE-2 MASH trial (statistically significant histologic and MRI-PDFF results) and received FDA Breakthrough Therapy designation for non-cirrhotic MASH F2-F3. Ascletis reported positive Phase 3 acne results for denifanstat in China. Sagimet is exploring Phase 3 funding and will initiate a Phase 1 PK study of denifanstat plus resmetirom in H2 2025, and started a Phase 1 trial of second candidate TVB-3567 in June 2025.
Sagimet Biosciences Inc. ha depositato un supplemento al prospetto per offrire fino a 75,0 milioni di dollari di azioni ordinarie di Serie A tramite un accordo di vendita "at-the-market" con Leerink Partners. Le azioni di Serie A sono quotate al Nasdaq con il simbolo SGMT e il prezzo dell’ultima negoziazione riportata è stato di 9,58 USD per azione il 13 agosto 2025. I proventi netti saranno impiegati per portare avanti lo sviluppo di denifanstat e di altri inibitori della FASN, per attività di R&S, capitale operativo e scopi societari generali.
Il supplemento sottolinea i progressi clinici: denifanstat ha raggiunto l’endpoint primario e più endpoint secondari nello studio di Fase 2b FASCINATE-2 per MASH (risultati istologici e MRI-PDFF statisticamente significativi) e ha ottenuto la designazione di Breakthrough Therapy dalla FDA per MASH non cirrotico F2-F3. Ascletis ha riportato risultati positivi di Fase 3 per l’acne da denifanstat in Cina. Sagimet sta valutando il finanziamento per la Fase 3, avvierà uno studio PK di Fase 1 su denifanstat in combinazione con resmetirom nella seconda metà del 2025 e ha iniziato a giugno 2025 uno studio di Fase 1 sul secondo candidato TVB-3567.
Sagimet Biosciences Inc. presentó un suplemento al prospecto para ofrecer hasta 75,0 millones de dólares en acciones ordinarias Serie A mediante un acuerdo de ventas "at-the-market" con Leerink Partners. Las acciones Serie A cotizan en Nasdaq con el símbolo SGMT y el último precio de venta informado fue de 9,58 USD por acción el 13 de agosto de 2025. Los ingresos netos se destinarán a avanzar en el desarrollo de denifanstat y otros inhibidores de FASN, a I+D, capital de trabajo y propósitos corporativos generales.
El suplemento destaca avances clínicos: denifanstat cumplió el objetivo primario y varios secundarios en el ensayo Fase 2b FASCINATE-2 para MASH (resultados histológicos y MRI-PDFF estadísticamente significativos) y recibió la designación Breakthrough Therapy de la FDA para MASH no cirrótico F2-F3. Ascletis informó resultados positivos de Fase 3 en acné con denifanstat en China. Sagimet está explorando financiación para Fase 3, iniciará un estudio PK de Fase 1 de denifanstat más resmetirom en la segunda mitad de 2025 y comenzó en junio de 2025 un ensayo de Fase 1 del segundo candidato TVB-3567.
Sagimet Biosciences Inc.는 Leerink Partners와의 "at-the-market" 판매 계약을 통해 최대 7,500만 달러 규모의 시리즈 A 보통주를 제공하기 위한 증권 발행 보충서를 제출했습니다. 시리즈 A 보통주는 나스닥에 SGMT로 거래되며, 마지막 보고된 거래 가격은 2025년 8월 13일 주당 9.58달러였습니다. 순수익은 데니판스타트(denifanstat) 및 기타 FASN 억제제 개발, 연구개발, 운전자본 및 일반 기업 목적에 사용될 예정입니다.
보충서에는 임상 진전이 강조되어 있습니다: 데니판스타트는 FASCINATE-2 MASH 2b상에서 1차 및 다수의 2차 종결점을 충족했으며(조직학적 및 MRI-PDFF에서 통계적 유의성 확보) 비간경변성 MASH F2-F3에 대해 FDA로부터 Breakthrough Therapy 지정을 받았습니다. Ascletis는 중국에서 데니판스타트의 여드름 3상 긍정적 결과를 보고했습니다. Sagimet은 3상 자금 조달을 검토 중이며, 2025년 하반기에 데니판스타트와 resmetirom 병용의 1상 약동학(PK) 시험을 시작할 예정이고, 2025년 6월에는 두 번째 후보물질 TVB-3567의 1상 시험을 개시했습니다.
Sagimet Biosciences Inc. a déposé un supplément de prospectus pour offrir jusqu’à 75,0 millions de dollars d’actions ordinaires de série A dans le cadre d’un accord de ventes "at-the-market" avec Leerink Partners. Les actions de série A sont cotées au Nasdaq sous le symbole SGMT et le dernier cours rapporté était de 9,58 $ par action le 13 août 2025. Le produit net servira à faire progresser le développement de denifanstat et d’autres inhibiteurs de la FASN, à la R&D, au fonds de roulement et à des fins générales de l’entreprise.
Le supplément met en avant des avancées cliniques : denifanstat a atteint l’objectif principal et plusieurs objectifs secondaires dans l’essai de phase 2b FASCINATE-2 pour la MASH (résultats histologiques et MRI-PDFF statistiquement significatifs) et a obtenu la désignation Breakthrough Therapy de la FDA pour la MASH non cirrhotique F2–F3. Ascletis a rapporté des résultats positifs de phase 3 sur l’acné pour denifanstat en Chine. Sagimet explore le financement de la phase 3, lancera une étude PK de phase 1 de denifanstat en association avec le resmetirom au second semestre 2025 et a démarré en juin 2025 un essai de phase 1 du second candidat TVB-3567.
Sagimet Biosciences Inc. hat einen Prospektergänzungsbogen eingereicht, um bis zu 75,0 Millionen US-Dollar an Series-A-Stammaktien über ein "at-the-market"-Verkaufsabkommen mit Leerink Partners anzubieten. Die Series-A-Aktien werden an der Nasdaq unter dem Symbol SGMT gehandelt; der zuletzt berichtete Verkaufspreis lag am 13. August 2025 bei 9,58 USD je Aktie. Die Nettoerlöse sollen zur Weiterentwicklung von Denifanstat und anderen FASN-Inhibitoren, für F&E, Betriebskapital und allgemeine Unternehmenszwecke verwendet werden.
Die Ergänzung hebt klinische Fortschritte hervor: Denifanstat erreichte sowohl den primären als auch mehrere sekundäre Endpunkte in der Phase-2b-Studie FASCINATE-2 bei MASH (statistisch signifikante histologische Befunde und MRI-PDFF) und erhielt die FDA-Breakthrough-Therapy-Zulassung für nicht-zirrhotische MASH F2–F3. Ascletis berichtete positive Phase-3-Ergebnisse für Denifanstat bei Akne in China. Sagimet prüft die Finanzierung einer Phase-3-Studie, wird in H2 2025 eine Phase-1-PK-Studie zu Denifanstat plus Resmetirom starten und begann im Juni 2025 eine Phase-1-Studie des zweiten Kandidaten TVB-3567.
- Denifanstat met both primary endpoints and multiple secondary endpoints in the Phase 2b FASCINATE-2 MASH trial with statistically significant results reported in mITT and ITT populations.
- FDA granted Breakthrough Therapy designation for denifanstat for non-cirrhotic MASH with F2-F3 fibrosis.
- Ascletis reported positive Phase 3 results for denifanstat in moderate to severe acne in China, and intends to seek regulatory approval in China.
- Company has an at-the-market Sales Agreement with Leerink Partners to raise up to $75.0 million, providing a flexible financing mechanism.
- Initiation of Phase 1 PK trial combining denifanstat with resmetirom planned in H2 2025 and Phase 1 trial of TVB-3567 initiated in June 2025.
- The company explicitly states it is exploring funding alternatives to initiate Phase 3 trials; Phase 3 initiation depends on securing additional capital.
- Illustrative dilution: after a $75.0 million assumed raise at $9.58 per share, as-adjusted net tangible book value per share would be $5.06, representing dilution to new investors of $4.52 per share based on company calculations.
- Treatment-emergent adverse events led to treatment discontinuation in 19.6% of denifanstat patients versus 5.4% for placebo in the Phase 2b study.
- At-the-market sales introduce uncertainty in timing and pricing of share issuance and could put downward pressure on the market price depending on volumes sold.
Insights
TL;DR: The ATM facility provides flexible funding but materially increases dilution risk; clinical milestones reduce technical risk but Phase 3 funding is unresolved.
The sales agreement with Leerink Partners enables up to $75.0 million of incremental capital through at-the-market sales, subject to market conditions and up to a 3.0% commission. This structure offers execution flexibility and immediate access to liquidity but creates unpredictable capital raise timing and potential downward pressure on share price from incremental supply. Management explicitly states it is exploring funding alternatives for Phase 3 MASH trials, indicating Phase 3 initiation depends on securing additional capital. Reported as-of June 30, 2025 net tangible book value and illustrative dilution metrics provide investors specific quantification of immediate dilution under the assumed $75.0 million raise.
TL;DR: Denifanstat shows multi-endpoint Phase 2b efficacy and FDA Breakthrough designation, supporting a credible path to Phase 3 pending funding.
FASCINATE-2 achieved statistically significant primary endpoints (>=2-point NAS reduction and MASH resolution without fibrosis worsening) in mITT and ITT populations, plus multiple secondary endpoints including fibrosis improvement and MRI-PDFF responses. The data include AI-based qFibrosis signals and subgroup signals (F3, GLP-1RA background) and no treatment-related SAEs or DILI signal. Ascletis’ reported Phase 3 acne success and ongoing GBM and combination studies broaden clinical validation. Material next steps are regulatory discussions and Phase 3 execution planning; success depends on trial design, enrollment, and funding.
Sagimet Biosciences Inc. ha depositato un supplemento al prospetto per offrire fino a 75,0 milioni di dollari di azioni ordinarie di Serie A tramite un accordo di vendita "at-the-market" con Leerink Partners. Le azioni di Serie A sono quotate al Nasdaq con il simbolo SGMT e il prezzo dell’ultima negoziazione riportata è stato di 9,58 USD per azione il 13 agosto 2025. I proventi netti saranno impiegati per portare avanti lo sviluppo di denifanstat e di altri inibitori della FASN, per attività di R&S, capitale operativo e scopi societari generali.
Il supplemento sottolinea i progressi clinici: denifanstat ha raggiunto l’endpoint primario e più endpoint secondari nello studio di Fase 2b FASCINATE-2 per MASH (risultati istologici e MRI-PDFF statisticamente significativi) e ha ottenuto la designazione di Breakthrough Therapy dalla FDA per MASH non cirrotico F2-F3. Ascletis ha riportato risultati positivi di Fase 3 per l’acne da denifanstat in Cina. Sagimet sta valutando il finanziamento per la Fase 3, avvierà uno studio PK di Fase 1 su denifanstat in combinazione con resmetirom nella seconda metà del 2025 e ha iniziato a giugno 2025 uno studio di Fase 1 sul secondo candidato TVB-3567.
Sagimet Biosciences Inc. presentó un suplemento al prospecto para ofrecer hasta 75,0 millones de dólares en acciones ordinarias Serie A mediante un acuerdo de ventas "at-the-market" con Leerink Partners. Las acciones Serie A cotizan en Nasdaq con el símbolo SGMT y el último precio de venta informado fue de 9,58 USD por acción el 13 de agosto de 2025. Los ingresos netos se destinarán a avanzar en el desarrollo de denifanstat y otros inhibidores de FASN, a I+D, capital de trabajo y propósitos corporativos generales.
El suplemento destaca avances clínicos: denifanstat cumplió el objetivo primario y varios secundarios en el ensayo Fase 2b FASCINATE-2 para MASH (resultados histológicos y MRI-PDFF estadísticamente significativos) y recibió la designación Breakthrough Therapy de la FDA para MASH no cirrótico F2-F3. Ascletis informó resultados positivos de Fase 3 en acné con denifanstat en China. Sagimet está explorando financiación para Fase 3, iniciará un estudio PK de Fase 1 de denifanstat más resmetirom en la segunda mitad de 2025 y comenzó en junio de 2025 un ensayo de Fase 1 del segundo candidato TVB-3567.
Sagimet Biosciences Inc.는 Leerink Partners와의 "at-the-market" 판매 계약을 통해 최대 7,500만 달러 규모의 시리즈 A 보통주를 제공하기 위한 증권 발행 보충서를 제출했습니다. 시리즈 A 보통주는 나스닥에 SGMT로 거래되며, 마지막 보고된 거래 가격은 2025년 8월 13일 주당 9.58달러였습니다. 순수익은 데니판스타트(denifanstat) 및 기타 FASN 억제제 개발, 연구개발, 운전자본 및 일반 기업 목적에 사용될 예정입니다.
보충서에는 임상 진전이 강조되어 있습니다: 데니판스타트는 FASCINATE-2 MASH 2b상에서 1차 및 다수의 2차 종결점을 충족했으며(조직학적 및 MRI-PDFF에서 통계적 유의성 확보) 비간경변성 MASH F2-F3에 대해 FDA로부터 Breakthrough Therapy 지정을 받았습니다. Ascletis는 중국에서 데니판스타트의 여드름 3상 긍정적 결과를 보고했습니다. Sagimet은 3상 자금 조달을 검토 중이며, 2025년 하반기에 데니판스타트와 resmetirom 병용의 1상 약동학(PK) 시험을 시작할 예정이고, 2025년 6월에는 두 번째 후보물질 TVB-3567의 1상 시험을 개시했습니다.
Sagimet Biosciences Inc. a déposé un supplément de prospectus pour offrir jusqu’à 75,0 millions de dollars d’actions ordinaires de série A dans le cadre d’un accord de ventes "at-the-market" avec Leerink Partners. Les actions de série A sont cotées au Nasdaq sous le symbole SGMT et le dernier cours rapporté était de 9,58 $ par action le 13 août 2025. Le produit net servira à faire progresser le développement de denifanstat et d’autres inhibiteurs de la FASN, à la R&D, au fonds de roulement et à des fins générales de l’entreprise.
Le supplément met en avant des avancées cliniques : denifanstat a atteint l’objectif principal et plusieurs objectifs secondaires dans l’essai de phase 2b FASCINATE-2 pour la MASH (résultats histologiques et MRI-PDFF statistiquement significatifs) et a obtenu la désignation Breakthrough Therapy de la FDA pour la MASH non cirrhotique F2–F3. Ascletis a rapporté des résultats positifs de phase 3 sur l’acné pour denifanstat en Chine. Sagimet explore le financement de la phase 3, lancera une étude PK de phase 1 de denifanstat en association avec le resmetirom au second semestre 2025 et a démarré en juin 2025 un essai de phase 1 du second candidat TVB-3567.
Sagimet Biosciences Inc. hat einen Prospektergänzungsbogen eingereicht, um bis zu 75,0 Millionen US-Dollar an Series-A-Stammaktien über ein "at-the-market"-Verkaufsabkommen mit Leerink Partners anzubieten. Die Series-A-Aktien werden an der Nasdaq unter dem Symbol SGMT gehandelt; der zuletzt berichtete Verkaufspreis lag am 13. August 2025 bei 9,58 USD je Aktie. Die Nettoerlöse sollen zur Weiterentwicklung von Denifanstat und anderen FASN-Inhibitoren, für F&E, Betriebskapital und allgemeine Unternehmenszwecke verwendet werden.
Die Ergänzung hebt klinische Fortschritte hervor: Denifanstat erreichte sowohl den primären als auch mehrere sekundäre Endpunkte in der Phase-2b-Studie FASCINATE-2 bei MASH (statistisch signifikante histologische Befunde und MRI-PDFF) und erhielt die FDA-Breakthrough-Therapy-Zulassung für nicht-zirrhotische MASH F2–F3. Ascletis berichtete positive Phase-3-Ergebnisse für Denifanstat bei Akne in China. Sagimet prüft die Finanzierung einer Phase-3-Studie, wird in H2 2025 eine Phase-1-PK-Studie zu Denifanstat plus Resmetirom starten und begann im Juni 2025 eine Phase-1-Studie des zweiten Kandidaten TVB-3567.
(To Prospectus dated August 26, 2024)
![[MISSING IMAGE: lg_sagimet-4c.jpg]](https://www.sec.gov/Archives/edgar/data/0001400118/000110465925078746/lg_sagimet-4c.jpg)
Series A Common Stock
| | |
Page
|
| |||
ABOUT THIS PROSPECTUS SUPPLEMENT
|
| | | | S-1 | | |
PROSPECTUS SUPPLEMENT SUMMARY
|
| | | | S-2 | | |
THE OFFERING
|
| | | | S-6 | | |
RISK FACTORS
|
| | | | S-8 | | |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
|
| | | | S-11 | | |
USE OF PROCEEDS
|
| | | | S-13 | | |
DILUTION
|
| | | | S-14 | | |
PLAN OF DISTRIBUTION
|
| | | | S-16 | | |
LEGAL MATTERS
|
| | | | S-18 | | |
EXPERTS
|
| | | | S-19 | | |
WHERE YOU CAN FIND MORE INFORMATION
|
| | | | S-20 | | |
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
|
| | | | S-21 | | |
| | |
Page
|
| |||
ABOUT THIS PROSPECTUS
|
| | | | 1 | | |
WHERE YOU CAN FIND MORE INFORMATION
|
| | | | 2 | | |
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
|
| | | | 2 | | |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
|
| | | | 4 | | |
ABOUT THE COMPANY
|
| | | | 6 | | |
RISK FACTORS
|
| | | | 9 | | |
USE OF PROCEEDS
|
| | | | 10 | | |
DESCRIPTION OF CAPITAL STOCK
|
| | | | 11 | | |
DESCRIPTION OF DEBT SECURITIES
|
| | | | 14 | | |
DESCRIPTION OF WARRANTS
|
| | | | 21 | | |
DESCRIPTION OF UNITS
|
| | | | 22 | | |
DESCRIPTION OF OUR SUBSCRIPTION RIGHTS
|
| | | | 23 | | |
GLOBAL SECURITIES
|
| | | | 24 | | |
PLAN OF DISTRIBUTION
|
| | | | 28 | | |
LEGAL MATTERS
|
| | | | 30 | | |
EXPERTS
|
| | | | 30 | | |
|
Assumed public offering price per share
|
| | | | | | | | | $ | 9.58 | | |
|
Net tangible book value per share as of June 30, 2025
|
| | | $ | 4.04 | | | | | | | | |
|
Increase in net tangible book value per share attributable to new investors purchasing shares in this offering
|
| | | $ | 1.02 | | | | | | | | |
|
As adjusted net tangible book value per share as of June 30, 2025 after giving effect to this
offering |
| | | | | | | | | $ | 5.06 | | |
|
Dilution per share to new investors in this offering
|
| | | | | | | | | $ | 4.52 | | |
155 Bovet Road, Suite 303
San Mateo, California 94402
(650) 561-8600
Attention: General Counsel
![[MISSING IMAGE: lg_sagimet-4c.jpg]](https://www.sec.gov/Archives/edgar/data/0001400118/000110465925078746/lg_sagimet-4c.jpg)
Preferred Stock
Debt Securities
Warrants
Units
Subscription Rights
| | |
Page
|
| |||
ABOUT THIS PROSPECTUS
|
| | | | 1 | | |
WHERE YOU CAN FIND MORE INFORMATION
|
| | | | 2 | | |
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
|
| | | | 2 | | |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
|
| | | | 4 | | |
ABOUT THE COMPANY
|
| | | | 6 | | |
RISK FACTORS
|
| | | | 9 | | |
USE OF PROCEEDS
|
| | | | 10 | | |
DESCRIPTION OF CAPITAL STOCK
|
| | | | 11 | | |
DESCRIPTION OF DEBT SECURITIES
|
| | | | 14 | | |
DESCRIPTION OF WARRANTS
|
| | | | 21 | | |
DESCRIPTION OF UNITS
|
| | | | 22 | | |
DESCRIPTION OF OUR SUBSCRIPTION RIGHTS
|
| | | | 23 | | |
GLOBAL SECURITIES
|
| | | | 24 | | |
PLAN OF DISTRIBUTION
|
| | | | 28 | | |
LEGAL MATTERS
|
| | | | 30 | | |
EXPERTS
|
| | | | 30 | | |
155 Bovet Road, Suite 303
San Mateo, California 94402
(650) 561-8600
Attention: General Counsel
![[MISSING IMAGE: lg_sagimet-4c.jpg]](https://www.sec.gov/Archives/edgar/data/0001400118/000110465925078746/lg_sagimet-4c.jpg)
Series A Common Stock