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[8-K] Genprex, Inc. Reports Material Event

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Genprex announced positive preclinical data for GPX-002, its diabetes gene therapy candidate, presented at the 2025 ADA Scientific Sessions. The research showcased a novel non-viral delivery approach using lipid nanoparticles (LNPs), marking a significant advancement in diabetes treatment technology.

Key findings include:

  • Successful testing of 9 LNPs with patented LipexSil庐 lipids, demonstrating efficient cell transfection in mouse Islets of Langerhans
  • ALX-184 LNP showed particular promise in crossing the pancreatic membrane and effectively delivering mRNA payloads
  • The non-viral delivery system potentially enables repeat dosing without immunosuppression, a significant advantage over traditional AAV delivery methods

This research runs parallel to Genprex's ongoing AAV construct studies, representing a strategic expansion of their diabetes program. The company believes these findings provide crucial proof of concept for advancing their Type 1 diabetes treatment approach, though they caution that all forward-looking statements are subject to risks and uncertainties.

Genprex ha annunciato dati preclinici positivi per GPX-002, il suo candidato di terapia genica per il diabete, presentati durante le Sessioni Scientifiche ADA 2025. La ricerca ha evidenziato un nuovo metodo di somministrazione non virale basato su nanoparticelle lipidiche (LNP), rappresentando un importante progresso nella tecnologia per il trattamento del diabete.

I risultati principali includono:

  • Test riusciti su 9 LNP contenenti lipidi brevettati LipexSil庐, che hanno dimostrato un'efficace trasfezione cellulare nelle isole di Langerhans di topo
  • LNP ALX-184 ha mostrato un potenziale particolare nel superare la membrana pancreatica e nel veicolare efficacemente il mRNA
  • Il sistema di somministrazione non virale potrebbe consentire dosaggi ripetuti senza immunosoppressione, un vantaggio significativo rispetto ai metodi tradizionali di somministrazione con AAV

Questa ricerca si affianca agli studi in corso di Genprex su costrutti AAV, rappresentando un'espansione strategica del loro programma per il diabete. L'azienda ritiene che questi risultati costituiscano una prova di concetto fondamentale per far progredire il trattamento del diabete di tipo 1, pur sottolineando che tutte le dichiarazioni previsionali sono soggette a rischi e incertezze.

Genprex anunci贸 datos precl铆nicos positivos para GPX-002, su candidato a terapia g茅nica para la diabetes, presentados en las Sesiones Cient铆ficas ADA 2025. La investigaci贸n mostr贸 un nuevo enfoque de administraci贸n no viral utilizando nanopart铆culas lip铆dicas (LNP), marcando un avance significativo en la tecnolog铆a para el tratamiento de la diabetes.

Los hallazgos clave incluyen:

  • Pruebas exitosas de 9 LNP con l铆pidos patentados LipexSil庐, demostrando una eficiente transfecci贸n celular en los Islotes de Langerhans de rat贸n
  • El LNP ALX-184 mostr贸 un potencial particular para atravesar la membrana pancre谩tica y entregar eficazmente la carga de mRNA
  • El sistema de administraci贸n no viral podr铆a permitir dosificaciones repetidas sin inmunosupresi贸n, una ventaja significativa sobre los m茅todos tradicionales de entrega con AAV

Esta investigaci贸n se realiza paralelamente a los estudios en curso de Genprex con constructos AAV, representando una expansi贸n estrat茅gica de su programa para la diabetes. La compa帽铆a considera que estos resultados proporcionan una prueba de concepto crucial para avanzar en su enfoque de tratamiento para la diabetes tipo 1, aunque advierte que todas las declaraciones prospectivas est谩n sujetas a riesgos e incertidumbres.

骋别苍辫谤别虫电� GPX-002 雼闺嚚氤� 鞙犾爠鞛� 旃橂 頉勲炒氍检鞐� 雽�頃� 旮嶌爼鞝侅澑 鞝勳瀯靸� 雿办澊韯半ゼ 2025 ADA 瓿柬暀 靹胳厴鞐愳劀 氚滍憸頄堨姷雼堧嫟. 鞚� 鞐瓣惮電� 歆�歆� 雮橂吀鞛呾瀽(LNP)毳� 鞚挫毄頃� 靸堧鞖� 牍勲皵鞚措煬鞀� 鞝勲嫭 氚╈嫕鞚� 靹犽炒鞚措┌, 雼闺嚚氤� 旃橂 旮办垹鞐� 欷戩殧頃� 歆勳爠鞚� 鞚措鞀惦媹雼�.

欤检殧 瓴瓣臣電� 雼れ潓瓿� 臧欖姷雼堧嫟:

  • 韸鬼棃 氚涭潃 LipexSil庐 歆�歆堨潉 韽暔頃� 9膦呾潣 LNP毳� 靹标车鞝侅溂搿� 鞁滍棙頃橃棳, 靸濎 霝戧矊毳错暅鞀� 靹� 靹疙彫 雮� 須湪鞝侅澑 靹疙彫 鞝勲嫭鞚� 鞛呾
  • ALX-184 LNP電� 旆岇灔毵夓潉 韱店臣頃橃棳 mRNA 鞝侅灛氍检潉 須臣鞝侅溂搿� 鞝勲嫭頃橂姅 雿� 韸鬼瀳 鞙犽頃�
  • 牍勲皵鞚措煬鞀� 鞝勲嫭 鞁滌姢韰滌潃 氅挫棴鞏奠牅 鞐嗢澊 氚橂车 韴棳臧� 臧�電�頃� 靾� 鞛堨柎, 旮办〈 AAV 鞝勲嫭 氚╈嫕鞐� 牍勴暣 韥� 鞛レ爯

鞚� 鞐瓣惮電� Genprex鞚� 歆勴枆 欷戩澑 AAV 甑“觳� 鞐瓣惮鞕� 氤戫枆頃橃棳, 雼闺嚚氤� 頂勲攴鸽灗鞚� 鞝勲灥鞝� 頇曥灔鞚� 鞚橂頃╇媹雼�. 須岇偓電� 鞚� 瓴瓣臣臧� 1順� 雼闺嚚氤� 旃橂 鞝戧芳氩曥潉 歆勳爠鞁滍偆電� 欷戩殧頃� 臧滊厫 歃濍獏鞚� 鞝滉车頃滊嫟瓿� 氙快毵�, 氇摖 氙鸽灅 鞓堨浮 歆勳垹鞚� 鞙勴棙瓿� 攵堩檿鞁れ劚鞐� 雲胳稖霅橃柎 鞛堨潓鞚� 瓴疥碃頃╇媹雼�.

Genprex a annonc茅 des donn茅es pr茅cliniques positives pour GPX-002, son candidat en th茅rapie g茅nique pour le diab猫te, pr茅sent茅 lors des Sessions Scientifiques ADA 2025. La recherche a mis en avant une nouvelle approche de d茅livrance non virale utilisant des nanoparticules lipidiques (LNP), marquant une avanc茅e significative dans la technologie de traitement du diab猫te.

Les r茅sultats cl茅s incluent :

  • Tests r茅ussis de 9 LNP contenant les lipides brevet茅s LipexSil庐, d茅montrant une transfection cellulaire efficace dans les 卯lots de Langerhans de souris
  • Le LNP ALX-184 a montr茅 un potentiel particulier pour traverser la membrane pancr茅atique et d茅livrer efficacement les charges d'ARNm
  • Le syst猫me de d茅livrance non viral pourrait permettre des doses r茅p茅t茅es sans immunosuppression, un avantage majeur par rapport aux m茅thodes traditionnelles utilisant les AAV

Cette recherche s'inscrit parall猫lement aux 茅tudes en cours de Genprex sur les constructions AAV, repr茅sentant une expansion strat茅gique de leur programme diab猫te. L'entreprise estime que ces r茅sultats apportent une preuve de concept essentielle pour faire progresser leur approche th茅rapeutique du diab猫te de type 1, tout en pr茅cisant que toutes les d茅clarations prospectives comportent des risques et des incertitudes.

Genprex hat positive pr盲klinische Daten f眉r GPX-002, seinen Gentherapie-Kandidaten f眉r Diabetes, vorgestellt, pr盲sentiert auf den 2025 ADA Scientific Sessions. Die Forschung zeigte einen neuartigen nicht-viralen Lieferansatz mittels Lipidnanopartikeln (LNPs), was einen bedeutenden Fortschritt in der Technologie zur Behandlung von Diabetes darstellt.

Wesentliche Ergebnisse umfassen:

  • Erfolgreiche Tests von 9 LNPs mit patentierten LipexSil庐-Lipiden, die eine effiziente Zelltransfektion in den Langerhans-Inseln von M盲usen demonstrierten
  • Das ALX-184 LNP zeigte besonderes Potenzial, die Pankreas-Membran zu durchdringen und mRNA-Wirkstoffe effektiv zu liefern
  • Das nicht-virale Liefersystem erm枚glicht m枚glicherweise wiederholte Dosierungen ohne Immunsuppression, ein erheblicher Vorteil gegen眉ber herk枚mmlichen AAV-Liefermethoden

Diese Forschung l盲uft parallel zu den laufenden AAV-Konstruktstudien von Genprex und stellt eine strategische Erweiterung ihres Diabetesprogramms dar. Das Unternehmen ist der Ansicht, dass diese Ergebnisse einen wichtigen Machbarkeitsnachweis f眉r die Weiterentwicklung ihres Behandlungsansatzes f眉r Typ-1-Diabetes liefern, weist jedoch darauf hin, dass alle zukunftsgerichteten Aussagen Risiken und Unsicherheiten unterliegen.

Positive
  • Successful preclinical data for GPX-002 diabetes gene therapy using novel non-viral delivery system, demonstrating efficient cell transfection in mouse studies
  • Development of new lipid nanoparticle (LNP) delivery system that could enable repeat dosing without immunosuppression, potentially improving treatment efficacy
  • Two specific LNPs showed high efficiency in transfecting 伪- and 尾-cells in isolated mouse Islets of Langerhans, providing proof of concept for the new delivery method
Negative
  • Company faces going concern issues and potential Nasdaq listing compliance challenges, as indicated in forward-looking statements
  • Significant uncertainty around ability to obtain capital for long-term liquidity needs

Insights

Genprex reports promising preclinical data for its diabetes gene therapy using a new delivery system that could enable repeat dosing.

Genprex's announcement of positive preclinical data for GPX-002 represents a potentially significant technical advancement for their diabetes gene therapy program. The company is exploring an alternative delivery approach using non-viral lipid nanoparticles (LNPs) instead of their standard adeno-associated virus (AAV) vector. The key scientific breakthrough here is the demonstration that specific LNPs can efficiently transfect 伪- and 尾-cells in the pancreatic islets of Langerhans - the exact cellular targets needed for diabetes therapy.

This alternative delivery mechanism offers two critical advantages over viral vectors: repeat dosing potential and no need for immunosuppression. The ability to re-dose patients could be transformative for treating Type 1 diabetes, as it would allow for titration and maintenance of therapeutic effect over time. The data showing that LNP-ALX-184 efficiently crossed the basement membrane separating the pancreatic duct from pancreatic cells via bile duct injection demonstrates a viable administration route for targeting these difficult-to-access cells.

What makes this development particularly noteworthy is that Genprex is pursuing this as a parallel path alongside their ongoing AAV construct work - essentially creating a potential next-generation version of GPX-002 before the first version has even reached clinical trials. This dual-track approach could accelerate their diabetes program's evolution and strengthen their intellectual property position in the diabetes gene therapy space.

Genprex ha annunciato dati preclinici positivi per GPX-002, il suo candidato di terapia genica per il diabete, presentati durante le Sessioni Scientifiche ADA 2025. La ricerca ha evidenziato un nuovo metodo di somministrazione non virale basato su nanoparticelle lipidiche (LNP), rappresentando un importante progresso nella tecnologia per il trattamento del diabete.

I risultati principali includono:

  • Test riusciti su 9 LNP contenenti lipidi brevettati LipexSil庐, che hanno dimostrato un'efficace trasfezione cellulare nelle isole di Langerhans di topo
  • LNP ALX-184 ha mostrato un potenziale particolare nel superare la membrana pancreatica e nel veicolare efficacemente il mRNA
  • Il sistema di somministrazione non virale potrebbe consentire dosaggi ripetuti senza immunosoppressione, un vantaggio significativo rispetto ai metodi tradizionali di somministrazione con AAV

Questa ricerca si affianca agli studi in corso di Genprex su costrutti AAV, rappresentando un'espansione strategica del loro programma per il diabete. L'azienda ritiene che questi risultati costituiscano una prova di concetto fondamentale per far progredire il trattamento del diabete di tipo 1, pur sottolineando che tutte le dichiarazioni previsionali sono soggette a rischi e incertezze.

Genprex anunci贸 datos precl铆nicos positivos para GPX-002, su candidato a terapia g茅nica para la diabetes, presentados en las Sesiones Cient铆ficas ADA 2025. La investigaci贸n mostr贸 un nuevo enfoque de administraci贸n no viral utilizando nanopart铆culas lip铆dicas (LNP), marcando un avance significativo en la tecnolog铆a para el tratamiento de la diabetes.

Los hallazgos clave incluyen:

  • Pruebas exitosas de 9 LNP con l铆pidos patentados LipexSil庐, demostrando una eficiente transfecci贸n celular en los Islotes de Langerhans de rat贸n
  • El LNP ALX-184 mostr贸 un potencial particular para atravesar la membrana pancre谩tica y entregar eficazmente la carga de mRNA
  • El sistema de administraci贸n no viral podr铆a permitir dosificaciones repetidas sin inmunosupresi贸n, una ventaja significativa sobre los m茅todos tradicionales de entrega con AAV

Esta investigaci贸n se realiza paralelamente a los estudios en curso de Genprex con constructos AAV, representando una expansi贸n estrat茅gica de su programa para la diabetes. La compa帽铆a considera que estos resultados proporcionan una prueba de concepto crucial para avanzar en su enfoque de tratamiento para la diabetes tipo 1, aunque advierte que todas las declaraciones prospectivas est谩n sujetas a riesgos e incertidumbres.

骋别苍辫谤别虫电� GPX-002 雼闺嚚氤� 鞙犾爠鞛� 旃橂 頉勲炒氍检鞐� 雽�頃� 旮嶌爼鞝侅澑 鞝勳瀯靸� 雿办澊韯半ゼ 2025 ADA 瓿柬暀 靹胳厴鞐愳劀 氚滍憸頄堨姷雼堧嫟. 鞚� 鞐瓣惮電� 歆�歆� 雮橂吀鞛呾瀽(LNP)毳� 鞚挫毄頃� 靸堧鞖� 牍勲皵鞚措煬鞀� 鞝勲嫭 氚╈嫕鞚� 靹犽炒鞚措┌, 雼闺嚚氤� 旃橂 旮办垹鞐� 欷戩殧頃� 歆勳爠鞚� 鞚措鞀惦媹雼�.

欤检殧 瓴瓣臣電� 雼れ潓瓿� 臧欖姷雼堧嫟:

  • 韸鬼棃 氚涭潃 LipexSil庐 歆�歆堨潉 韽暔頃� 9膦呾潣 LNP毳� 靹标车鞝侅溂搿� 鞁滍棙頃橃棳, 靸濎 霝戧矊毳错暅鞀� 靹� 靹疙彫 雮� 須湪鞝侅澑 靹疙彫 鞝勲嫭鞚� 鞛呾
  • ALX-184 LNP電� 旆岇灔毵夓潉 韱店臣頃橃棳 mRNA 鞝侅灛氍检潉 須臣鞝侅溂搿� 鞝勲嫭頃橂姅 雿� 韸鬼瀳 鞙犽頃�
  • 牍勲皵鞚措煬鞀� 鞝勲嫭 鞁滌姢韰滌潃 氅挫棴鞏奠牅 鞐嗢澊 氚橂车 韴棳臧� 臧�電�頃� 靾� 鞛堨柎, 旮办〈 AAV 鞝勲嫭 氚╈嫕鞐� 牍勴暣 韥� 鞛レ爯

鞚� 鞐瓣惮電� Genprex鞚� 歆勴枆 欷戩澑 AAV 甑“觳� 鞐瓣惮鞕� 氤戫枆頃橃棳, 雼闺嚚氤� 頂勲攴鸽灗鞚� 鞝勲灥鞝� 頇曥灔鞚� 鞚橂頃╇媹雼�. 須岇偓電� 鞚� 瓴瓣臣臧� 1順� 雼闺嚚氤� 旃橂 鞝戧芳氩曥潉 歆勳爠鞁滍偆電� 欷戩殧頃� 臧滊厫 歃濍獏鞚� 鞝滉车頃滊嫟瓿� 氙快毵�, 氇摖 氙鸽灅 鞓堨浮 歆勳垹鞚� 鞙勴棙瓿� 攵堩檿鞁れ劚鞐� 雲胳稖霅橃柎 鞛堨潓鞚� 瓴疥碃頃╇媹雼�.

Genprex a annonc茅 des donn茅es pr茅cliniques positives pour GPX-002, son candidat en th茅rapie g茅nique pour le diab猫te, pr茅sent茅 lors des Sessions Scientifiques ADA 2025. La recherche a mis en avant une nouvelle approche de d茅livrance non virale utilisant des nanoparticules lipidiques (LNP), marquant une avanc茅e significative dans la technologie de traitement du diab猫te.

Les r茅sultats cl茅s incluent :

  • Tests r茅ussis de 9 LNP contenant les lipides brevet茅s LipexSil庐, d茅montrant une transfection cellulaire efficace dans les 卯lots de Langerhans de souris
  • Le LNP ALX-184 a montr茅 un potentiel particulier pour traverser la membrane pancr茅atique et d茅livrer efficacement les charges d'ARNm
  • Le syst猫me de d茅livrance non viral pourrait permettre des doses r茅p茅t茅es sans immunosuppression, un avantage majeur par rapport aux m茅thodes traditionnelles utilisant les AAV

Cette recherche s'inscrit parall猫lement aux 茅tudes en cours de Genprex sur les constructions AAV, repr茅sentant une expansion strat茅gique de leur programme diab猫te. L'entreprise estime que ces r茅sultats apportent une preuve de concept essentielle pour faire progresser leur approche th茅rapeutique du diab猫te de type 1, tout en pr茅cisant que toutes les d茅clarations prospectives comportent des risques et des incertitudes.

Genprex hat positive pr盲klinische Daten f眉r GPX-002, seinen Gentherapie-Kandidaten f眉r Diabetes, vorgestellt, pr盲sentiert auf den 2025 ADA Scientific Sessions. Die Forschung zeigte einen neuartigen nicht-viralen Lieferansatz mittels Lipidnanopartikeln (LNPs), was einen bedeutenden Fortschritt in der Technologie zur Behandlung von Diabetes darstellt.

Wesentliche Ergebnisse umfassen:

  • Erfolgreiche Tests von 9 LNPs mit patentierten LipexSil庐-Lipiden, die eine effiziente Zelltransfektion in den Langerhans-Inseln von M盲usen demonstrierten
  • Das ALX-184 LNP zeigte besonderes Potenzial, die Pankreas-Membran zu durchdringen und mRNA-Wirkstoffe effektiv zu liefern
  • Das nicht-virale Liefersystem erm枚glicht m枚glicherweise wiederholte Dosierungen ohne Immunsuppression, ein erheblicher Vorteil gegen眉ber herk枚mmlichen AAV-Liefermethoden

Diese Forschung l盲uft parallel zu den laufenden AAV-Konstruktstudien von Genprex und stellt eine strategische Erweiterung ihres Diabetesprogramms dar. Das Unternehmen ist der Ansicht, dass diese Ergebnisse einen wichtigen Machbarkeitsnachweis f眉r die Weiterentwicklung ihres Behandlungsansatzes f眉r Typ-1-Diabetes liefern, weist jedoch darauf hin, dass alle zukunftsgerichteten Aussagen Risiken und Unsicherheiten unterliegen.

false 0001595248 0001595248 2025-06-23 2025-06-23
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549 
   
 
 
FORM 8-K
    
 
 
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
 
June 23, 2025
Date of report (Date of earliest event reported)
 
GENPREX, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
001-38244
90-0772347
(State or other jurisdiction of
incorporation or organization)
(Commission File Number)
(I.R.S. Employer
Identification Number)
     
3300 Bee Cave Road, #650-227, Austin, TX
  
78746
(Address of principal executive offices)
  
(Zip Code)
 
Registrant’s telephone number, including area code: (512) 537-7997
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
 
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
  
Trading
Symbol(s)
  
Name of each exchange on which registered
Common Stock, par value $0.001 per share
  
GNPX
  
The Nasdaq Capital Market
 
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).
Emerging growth company ☐
 
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. ☐
 
 
 
 
Item 8.01 Other Events.
 
On June 23, 2025, Genprex, Inc. (“Genprex” or the “Company”) issued a press release announcing its research collaborators presented positive preclinical data and research from studies of GPX-002, the Company’s diabetes gene therapy drug candidate, at the 2025 American Diabetes Association (“ADA”) 85th Scientific Sessions in Chicago, Illinois.  The studies used an alternative second-generation approach with a non-viral lipid nanoparticle delivery system. The release noted that this exploratory research represents the Company’s forward-thinking work within its diabetes program to determine if the novel diabetes gene therapy can be delivered using a non-viral delivery system which could allow for repeat dosing.
 
The Company noted in its release that it believes the research demonstrates the Company’s ability to use a lipid nanoparticle with a nucleic acid payload to transfect cells within the islets of Langerhans via a direct infusion into the biliary duct/pancreatic duct in place of a viral AAV construct.  The press release further states the Company’s belief that these findings provide the proof of concept needed to move forward with additional studies and opens the door for a next generation approach of our novel gene therapy that would allow repeat dosing of patients, which the Company believes may prove to be very important in the potential treatment of Type 1 diabetes.
 
In the research study, nine lipid nanoparticles (“LNPs”) prepared with patented LipexSil® lipids with a green fluorescent protein (“GFP”) messenger RNA (“mRNA”) payload were evaluated for transfection efficiency in isolated mouse Islets of Langerhans. Two specific LNPs were highly efficient in transfecting α- and β-cells in isolated mouse Islets of Langerhans. LNP made using ALX-184 with a Luciferase mRNA payload injected into the mouse common bile duct efficiently transfected pancreatic cells, and thus efficiently crossed the basement membrane separating the pancreatic duct from pancreatic cells. The same LNP made using ALX-184 with a GFP mRNA payload injected into the mouse common bile duct also efficiently transfected mouse Islet of Langerhans cells.
 
Genprex’s research with its contract development and manufacturing organization partner is in addition to its ongoing preclinical studies using an adeno-associated virus, or AAV, construct. This new research is focused on evaluating potential next generation construct optimization. While AAV delivery is a well understood delivery mechanism, the Company believes there could be many benefits to a non-viral delivery system, including the potential for re-dosing patients to optimize treatment. Additionally, there may be no need for immunosuppression since there is no immune response against LNPs.
 
Cautionary Language Concerning Forward-Looking Statements
 
Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K for the year ended December 31, 2024.
 
Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Genprex’s ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines; the timing and success of Genprex’s clinical trials and regulatory approvals, including but not limited to, the Company’s beliefs about the anticipated effects of GPX-002 and its potential as a therapeutic approach, whether using AAV delivery or a potential second generation non-viral delivery system; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes; the effects of any strategic research and development prioritization initiatives, and any other strategic alternatives or other efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex’s diabetes, oncology and/or other clinical development programs including prioritization of resources, and the extent to which Genprex is able to implement such efforts and initiatives successfully to achieve the desired and intended results thereof; Genprex’s future growth and financial status, including Genprex’s ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex’s commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex’s intellectual property and licenses.
 
These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this filing. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this filing or to reflect the occurrence of unanticipated events, except as required by law.
 
Item 9.01 Financial Statements and Exhibits.
 
(d) Exhibits.
 
Exhibit
Number
 
 Description
     
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.
 
 
GENPREX, INC.
  
       
Date: June 23, 2025
By:
/s/ Ryan Confer
  
   
Ryan Confer
  
   
Chief Executive Officer and Chief Financial Officer
(Principal Executive Officer and Principal Financial and Accounting Officer)
  
 
 

Source:

FAQ

What did GNPX announce in their June 23, 2025 8-K filing?

GNPX announced positive preclinical data for GPX-002, their diabetes gene therapy drug candidate, presented at the 2025 American Diabetes Association Scientific Sessions. The research demonstrated success using a non-viral lipid nanoparticle delivery system, which represents an alternative second-generation approach to their therapy.

What are the key benefits of GNPX's new lipid nanoparticle delivery system for GPX-002?

The key benefits include: 1) The potential for repeat dosing of patients, which could be important for Type 1 diabetes treatment, 2) No need for immunosuppression since there is no immune response against LNPs, and 3) Efficient transfection of pancreatic cells through the basement membrane when injected into the mouse common bile duct.

What were the specific results of GNPX's lipid nanoparticle research studies?

The research evaluated nine lipid nanoparticles (LNPs) with GFP mRNA payload, finding that two specific LNPs were highly efficient in transfecting 伪- and 尾-cells in isolated mouse Islets of Langerhans. LNP made using ALX-184 with both Luciferase mRNA and GFP mRNA payloads showed efficient transfection of pancreatic cells when injected into the mouse common bile duct.

Who is currently leading GNPX as of June 2025?

According to the filing's signature section, Ryan Confer is serving as both Chief Executive Officer and Chief Financial Officer of Genprex, holding the positions of Principal Executive Officer and Principal Financial and Accounting Officer.

Where is GNPX stock traded and what is its registration status?

GNPX common stock, with a par value of $0.001 per share, is traded on The Nasdaq Capital Market under the trading symbol 'GNPX'.
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Genprex Inc

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GNPX Rankings

#6175 Ranked by Market Cap
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GNPX Latest News

Aug 18, 2025
Genprex Receives Notice of Allowance for Multiple Patents for Reqorsa庐 Gene Therapy with PD-L1 and PD-1 Antibodies to Treat Cancers
Aug 4, 2025
Genprex Issues Stockholder Letter and Provides 2025 Corporate Update
Jun 24, 2025
Genprex Collaborators Present Positive Preclinical Research on Diabetes Gene Therapy at the 2025 American Diabetes Association 85th Scientific Sessions
Jun 23, 2025
Genprex Collaborators Present Research on Non-Viral Approach to Diabetes Gene Therapy Using Lipid Nanoparticle Delivery System at the 2025 American Diabetes Association 85th Scientific Sessions
Jun 3, 2025
Genprex to Participate at BIO 2025 International Convention

GNPX Latest SEC Filings

Aug 18, 2025
[8-K] Genprex, Inc. Reports Material Event
Aug 15, 2025
[8-K] Genprex, Inc. Reports Material Event
Aug 5, 2025
[RW] Genprex, Inc. SEC Filing
Aug 4, 2025
[8-K] Genprex, Inc. Reports Material Event
Jul 16, 2025
[DEF 14A] Genprex, Inc. Definitive Proxy Statement

GNPX Stock Data

7.10M
33.36M
0.33%
1.41%
2.49%
Biotechnology
Pharmaceutical Preparations
United States
AUSTIN