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[6-K] NLS Pharmaceutics Ltd. Warrant Current Report (Foreign Issuer)

Filing Impact
(Low)
Filing Sentiment
(Neutral)
Form Type
6-K
Rhea-AI Filing Summary

Form 8-K Item 8.01 � Other Events

On 30 June 2025, MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) disclosed pre-clinical data for SKNY-1, an oral therapeutic it is under definitive agreement to acquire from SKNY Pharmaceuticals. In a zebrafish model simulating human obesity and craving behaviour, six-day oral dosing produced an approximate 30 % body-weight reduction, leaving treated animals 10 % lighter than healthy controls while preserving muscle density. Metabolic indicators improved, including higher ventilation rate, normalised liver fat, and restoration of both LDL and HDL cholesterol to healthy levels without raising circulating triglycerides.

Behaviourally, SKNY-1 dose-dependently suppressed high-calorie consumption, reduced compulsive food seeking, and eliminated nicotine-seeking even under stress. The compound also normalised leptin and ghrelin and, at lower doses, reduced elevated dopamine linked to reward cravings.

The company states that these results warrant advancement into IND-enabling studies and positions SKNY-1 as a potential cornerstone asset once the acquisition closes, citing a combined obesity and smoking market opportunity exceeding US$200 billion.

The filing does not include human data, transaction financials, development costs, or projected timelines.

Modulo 8-K Voce 8.01 � Altri Eventi

Il 30 giugno 2025, MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) ha divulgato dati preclinici su SKNY-1, un trattamento orale che sta acquisendo tramite un accordo definitivo con SKNY Pharmaceuticals. In un modello di zebrafish che simula l'obesità umana e il comportamento di desiderio, una somministrazione orale di sei giorni ha prodotto una riduzione del peso corporeo di circa il 30%, lasciando gli animali trattati il 10% più leggeri rispetto ai controlli sani, mantenendo la densità muscolare. Gli indicatori metabolici sono migliorati, con un aumento della frequenza respiratoria, normalizzazione del grasso epatico e ripristino dei livelli di colesterolo LDL e HDL a valori sani senza aumentare i trigliceridi circolanti.

Dal punto di vista comportamentale, SKNY-1 ha ridotto in modo dose-dipendente il consumo di cibi ad alto contenuto calorico, diminuito la ricerca compulsiva di cibo e eliminato la ricerca di nicotina anche sotto stress. Il composto ha inoltre normalizzato leptina e grelina e, a dosi più basse, ridotto la dopamina elevata legata alle voglie di ricompensa.

L'azienda afferma che questi risultati giustificano il passaggio a studi per l'abilitazione IND e posizionano SKNY-1 come un potenziale asset chiave una volta conclusa l'acquisizione, citando un'opportunità di mercato combinata per obesità e fumo superiore a 200 miliardi di dollari USA.

Il documento non include dati umani, dettagli finanziari della transazione, costi di sviluppo o tempistiche previste.

Formulario 8-K Punto 8.01 � Otros Eventos

El 30 de junio de 2025, MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) divulgó datos preclínicos de SKNY-1, un tratamiento oral que está en proceso de adquisición definitiva de SKNY Pharmaceuticals. En un modelo de pez cebra que simula la obesidad humana y el comportamiento de antojo, una dosificación oral de seis días produjo una reducción aproximada del 30% en el peso corporal, dejando a los animales tratados un 10% más ligeros que los controles sanos, preservando la densidad muscular. Los indicadores metabólicos mejoraron, incluyendo una mayor tasa de ventilación, normalización de la grasa hepática y restauración de los niveles de colesterol LDL y HDL a valores saludables sin aumentar los triglicéridos circulantes.

En cuanto al comportamiento, SKNY-1 suprimió de manera dosis-dependiente el consumo de alimentos altos en calorías, redujo la búsqueda compulsiva de comida y eliminó la búsqueda de nicotina incluso bajo estrés. El compuesto también normalizó la leptina y la grelina y, en dosis más bajas, redujo la dopamina elevada vinculada a los antojos de recompensa.

La compañía declara que estos resultados justifican avanzar hacia estudios para la habilitación del IND y posicionan a SKNY-1 como un activo potencial clave una vez que se cierre la adquisición, citando una oportunidad de mercado combinada para obesidad y tabaquismo que supera los 200 mil millones de dólares estadounidenses.

El informe no incluye datos humanos, detalles financieros de la transacción, costos de desarrollo ni cronogramas proyectados.

양식 8-K 항목 8.01 � 기타 사건

2025� 6� 30�, MIRA Pharmaceuticals, Inc. (나스�: MIRA)� SKNY Pharmaceuticals로부� 최종 계약� 통해 인수� 예정� 경구 치료� SKNY-1� 전임� 데이터를 공개했습니다. 인간 비만 � 갈망 행동� 모사� 제브라피� 모델에서 6일간 경구 투여 � 체중� � 30% 감소했으�, 치료받은 개체� 건강� 대조군보다 10% 가벼우면서� 근육 밀도는 유지되었습니�. 대� 지표도 개선되어 환기� 증가, � 지� 정상�, LDL � HDL 콜레스테롤이 건강� 수준으로 회복되었으며 순환 � 중성지방은 증가하지 않았습니�.

행동 측면에서 SKNY-1은 용량 의존적으� 고칼로리 섭취� 억제하고 강박적인 음식 탐색� 줄였으며 스트레스 상황에서� 니코� 탐색� 완전� 제거했습니다. � 화합물은 렙틴� 그렐린을 정상화했으며 낮은 용량에서� 보상 갈망� 관련된 도파� 과다� 감소시켰습니�.

회사� 이러� 결과가 IND 승인 연구로의 진전� 정당화하�, 인수 완료 � SKNY-1� 비만� 흡연 시장 기회가 2,000� 달러� 초과하는 잠재� 핵심 자산으로 자리매김� 것이라고 밝혔습니�.

이번 공시에는 인간 데이�, 거래 재무 정보, 개발 비용 또는 예상 일정은 포함되어 있지 않습니다.

Formulaire 8-K Article 8.01 � Autres Événements

Le 30 juin 2025, MIRA Pharmaceuticals, Inc. (Nasdaq : MIRA) a publié des données précliniques concernant SKNY-1, un traitement oral qu'elle est en passe d'acquérir auprès de SKNY Pharmaceuticals dans le cadre d'un accord définitif. Dans un modèle de poisson-zèbre simulant l'obésité humaine et les comportements de fringale, une administration orale de six jours a entraîné une réduction d'environ 30 % du poids corporel, les animaux traités étant 10 % plus légers que les témoins sains tout en conservant leur densité musculaire. Les indicateurs métaboliques se sont améliorés, avec une ventilation accrue, une normalisation de la graisse hépatique et une restauration des taux de cholestérol LDL et HDL à des niveaux sains sans augmentation des triglycérides circulants.

Comportementalement, SKNY-1 a supprimé de manière dose-dépendante la consommation d'aliments riches en calories, réduit la recherche compulsive de nourriture et éliminé la recherche de nicotine même en situation de stress. Le composé a également normalisé la leptine et la ghréline et, à faibles doses, réduit la dopamine élevée liée aux envies de récompense.

La société déclare que ces résultats justifient une avancée vers des études permettant l'IND et positionnent SKNY-1 comme un actif potentiel majeur une fois l'acquisition finalisée, citant une opportunité de marché combinée pour l'obésité et le tabagisme dépassant les 200 milliards de dollars américains.

Le dépôt ne comprend pas de données humaines, de détails financiers sur la transaction, de coûts de développement ni de calendriers prévisionnels.

Formular 8-K Punkt 8.01 � Sonstige Ereignisse

Am 30. Juni 2025 gab MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) präklinische Daten zu SKNY-1 bekannt, einem oralen Therapeutikum, das im Rahmen einer endgültigen Vereinbarung von SKNY Pharmaceuticals erworben werden soll. In einem Zebrafischmodell, das menschliche Fettleibigkeit und Verlangen simuliert, führte eine sechstägige orale Verabreichung zu einer etwa 30%igen Gewichtsreduktion, wobei die behandelten Tiere 10% leichter als gesunde Kontrolltiere blieben und dabei die Muskelmasse erhalten wurde. Metabolische Indikatoren verbesserten sich, darunter eine erhöhte Belüftungsrate, normalisiertes Leberfett sowie die Wiederherstellung von LDL- und HDL-Cholesterin auf gesunde Werte, ohne die zirkulierenden Triglyzeride zu erhöhen.

Verhaltensbezogen unterdrückte SKNY-1 dosisabhängig den Konsum kalorienreicher Lebensmittel, reduzierte zwanghaftes Futterverhalten und beseitigte selbst unter Stress das Nikotinsuchverhalten. Die Verbindung normalisierte zudem Leptin und Ghrelin und reduzierte bei niedrigeren Dosen das erhöhte Dopamin, das mit Belohnungssehnsüchten verbunden ist.

Das Unternehmen erklärt, dass diese Ergebnisse den Übergang zu IND-fähigen Studien rechtfertigen und SKNY-1 nach Abschluss der Übernahme als potenzielles Kernprodukt positionieren, wobei ein kombinierter Markt für Fettleibigkeit und Rauchen von über 200 Milliarden US-Dollar angegeben wird.

Die Einreichung enthält keine Human-Daten, finanzielle Transaktionsdetails, Entwicklungskosten oder prognostizierte Zeitpläne.

Positive
  • ~30% weight loss achieved in six days with no muscle density reduction.
  • Suppression of both high-calorie and nicotine cravings broadens therapeutic scope.
  • Normalisation of liver fat and cholesterol suggests systemic metabolic benefit.
Negative
  • Results limited to a zebrafish model; no mammalian or human data disclosed.
  • Acquisition of SKNY Pharmaceuticals has not yet closed, introducing transaction risk.
  • No financial terms, cost projections or development timeline were provided.

Insights

Encouraging pre-clinical efficacy but zebrafish data alone is insufficient; commercial upside depends on acquisition closing and human trials.

The 8-K provides promising mechanistic and efficacy signals for SKNY-1: ~30% weight reduction, normalised metabolic markers and dual craving suppression after only six days of oral dosing. These endpoints outpace some existing GLP-1 data in speed, albeit in a non-mammalian model. The candidate potentially addresses two multi-billion-dollar indications, supporting management’s plan to prioritise the asset post-acquisition. However, the data remain early stage—no rodent or primate work, pharmacokinetics or safety profiles were disclosed. IND-enabling studies and the closing of the SKNY Pharmaceuticals deal are prerequisites before investors can attribute tangible value. Overall impact: headline-positive, but valuation-neutral until additional milestones are met.

Interesting science; too early for portfolio thesis change without clinical timeline or cost guidance.

The update signals strategic intent to enter the competitive obesity market, yet the filing omits acquisition consideration, funding plan and development budget. Absent human data and regulatory schedule, near-term cash-flow visibility is limited. The market may react positively to the weight-loss headline, but durability of any share move is questionable. I view the disclosure as awareness-building rather than value-moving.

Modulo 8-K Voce 8.01 � Altri Eventi

Il 30 giugno 2025, MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) ha divulgato dati preclinici su SKNY-1, un trattamento orale che sta acquisendo tramite un accordo definitivo con SKNY Pharmaceuticals. In un modello di zebrafish che simula l'obesità umana e il comportamento di desiderio, una somministrazione orale di sei giorni ha prodotto una riduzione del peso corporeo di circa il 30%, lasciando gli animali trattati il 10% più leggeri rispetto ai controlli sani, mantenendo la densità muscolare. Gli indicatori metabolici sono migliorati, con un aumento della frequenza respiratoria, normalizzazione del grasso epatico e ripristino dei livelli di colesterolo LDL e HDL a valori sani senza aumentare i trigliceridi circolanti.

Dal punto di vista comportamentale, SKNY-1 ha ridotto in modo dose-dipendente il consumo di cibi ad alto contenuto calorico, diminuito la ricerca compulsiva di cibo e eliminato la ricerca di nicotina anche sotto stress. Il composto ha inoltre normalizzato leptina e grelina e, a dosi più basse, ridotto la dopamina elevata legata alle voglie di ricompensa.

L'azienda afferma che questi risultati giustificano il passaggio a studi per l'abilitazione IND e posizionano SKNY-1 come un potenziale asset chiave una volta conclusa l'acquisizione, citando un'opportunità di mercato combinata per obesità e fumo superiore a 200 miliardi di dollari USA.

Il documento non include dati umani, dettagli finanziari della transazione, costi di sviluppo o tempistiche previste.

Formulario 8-K Punto 8.01 � Otros Eventos

El 30 de junio de 2025, MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) divulgó datos preclínicos de SKNY-1, un tratamiento oral que está en proceso de adquisición definitiva de SKNY Pharmaceuticals. En un modelo de pez cebra que simula la obesidad humana y el comportamiento de antojo, una dosificación oral de seis días produjo una reducción aproximada del 30% en el peso corporal, dejando a los animales tratados un 10% más ligeros que los controles sanos, preservando la densidad muscular. Los indicadores metabólicos mejoraron, incluyendo una mayor tasa de ventilación, normalización de la grasa hepática y restauración de los niveles de colesterol LDL y HDL a valores saludables sin aumentar los triglicéridos circulantes.

En cuanto al comportamiento, SKNY-1 suprimió de manera dosis-dependiente el consumo de alimentos altos en calorías, redujo la búsqueda compulsiva de comida y eliminó la búsqueda de nicotina incluso bajo estrés. El compuesto también normalizó la leptina y la grelina y, en dosis más bajas, redujo la dopamina elevada vinculada a los antojos de recompensa.

La compañía declara que estos resultados justifican avanzar hacia estudios para la habilitación del IND y posicionan a SKNY-1 como un activo potencial clave una vez que se cierre la adquisición, citando una oportunidad de mercado combinada para obesidad y tabaquismo que supera los 200 mil millones de dólares estadounidenses.

El informe no incluye datos humanos, detalles financieros de la transacción, costos de desarrollo ni cronogramas proyectados.

양식 8-K 항목 8.01 � 기타 사건

2025� 6� 30�, MIRA Pharmaceuticals, Inc. (나스�: MIRA)� SKNY Pharmaceuticals로부� 최종 계약� 통해 인수� 예정� 경구 치료� SKNY-1� 전임� 데이터를 공개했습니다. 인간 비만 � 갈망 행동� 모사� 제브라피� 모델에서 6일간 경구 투여 � 체중� � 30% 감소했으�, 치료받은 개체� 건강� 대조군보다 10% 가벼우면서� 근육 밀도는 유지되었습니�. 대� 지표도 개선되어 환기� 증가, � 지� 정상�, LDL � HDL 콜레스테롤이 건강� 수준으로 회복되었으며 순환 � 중성지방은 증가하지 않았습니�.

행동 측면에서 SKNY-1은 용량 의존적으� 고칼로리 섭취� 억제하고 강박적인 음식 탐색� 줄였으며 스트레스 상황에서� 니코� 탐색� 완전� 제거했습니다. � 화합물은 렙틴� 그렐린을 정상화했으며 낮은 용량에서� 보상 갈망� 관련된 도파� 과다� 감소시켰습니�.

회사� 이러� 결과가 IND 승인 연구로의 진전� 정당화하�, 인수 완료 � SKNY-1� 비만� 흡연 시장 기회가 2,000� 달러� 초과하는 잠재� 핵심 자산으로 자리매김� 것이라고 밝혔습니�.

이번 공시에는 인간 데이�, 거래 재무 정보, 개발 비용 또는 예상 일정은 포함되어 있지 않습니다.

Formulaire 8-K Article 8.01 � Autres Événements

Le 30 juin 2025, MIRA Pharmaceuticals, Inc. (Nasdaq : MIRA) a publié des données précliniques concernant SKNY-1, un traitement oral qu'elle est en passe d'acquérir auprès de SKNY Pharmaceuticals dans le cadre d'un accord définitif. Dans un modèle de poisson-zèbre simulant l'obésité humaine et les comportements de fringale, une administration orale de six jours a entraîné une réduction d'environ 30 % du poids corporel, les animaux traités étant 10 % plus légers que les témoins sains tout en conservant leur densité musculaire. Les indicateurs métaboliques se sont améliorés, avec une ventilation accrue, une normalisation de la graisse hépatique et une restauration des taux de cholestérol LDL et HDL à des niveaux sains sans augmentation des triglycérides circulants.

Comportementalement, SKNY-1 a supprimé de manière dose-dépendante la consommation d'aliments riches en calories, réduit la recherche compulsive de nourriture et éliminé la recherche de nicotine même en situation de stress. Le composé a également normalisé la leptine et la ghréline et, à faibles doses, réduit la dopamine élevée liée aux envies de récompense.

La société déclare que ces résultats justifient une avancée vers des études permettant l'IND et positionnent SKNY-1 comme un actif potentiel majeur une fois l'acquisition finalisée, citant une opportunité de marché combinée pour l'obésité et le tabagisme dépassant les 200 milliards de dollars américains.

Le dépôt ne comprend pas de données humaines, de détails financiers sur la transaction, de coûts de développement ni de calendriers prévisionnels.

Formular 8-K Punkt 8.01 � Sonstige Ereignisse

Am 30. Juni 2025 gab MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) präklinische Daten zu SKNY-1 bekannt, einem oralen Therapeutikum, das im Rahmen einer endgültigen Vereinbarung von SKNY Pharmaceuticals erworben werden soll. In einem Zebrafischmodell, das menschliche Fettleibigkeit und Verlangen simuliert, führte eine sechstägige orale Verabreichung zu einer etwa 30%igen Gewichtsreduktion, wobei die behandelten Tiere 10% leichter als gesunde Kontrolltiere blieben und dabei die Muskelmasse erhalten wurde. Metabolische Indikatoren verbesserten sich, darunter eine erhöhte Belüftungsrate, normalisiertes Leberfett sowie die Wiederherstellung von LDL- und HDL-Cholesterin auf gesunde Werte, ohne die zirkulierenden Triglyzeride zu erhöhen.

Verhaltensbezogen unterdrückte SKNY-1 dosisabhängig den Konsum kalorienreicher Lebensmittel, reduzierte zwanghaftes Futterverhalten und beseitigte selbst unter Stress das Nikotinsuchverhalten. Die Verbindung normalisierte zudem Leptin und Ghrelin und reduzierte bei niedrigeren Dosen das erhöhte Dopamin, das mit Belohnungssehnsüchten verbunden ist.

Das Unternehmen erklärt, dass diese Ergebnisse den Übergang zu IND-fähigen Studien rechtfertigen und SKNY-1 nach Abschluss der Übernahme als potenzielles Kernprodukt positionieren, wobei ein kombinierter Markt für Fettleibigkeit und Rauchen von über 200 Milliarden US-Dollar angegeben wird.

Die Einreichung enthält keine Human-Daten, finanzielle Transaktionsdetails, Entwicklungskosten oder prognostizierte Zeitpläne.

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

 

For the month of June 2025 (Report No. 4)

 

Commission file number: 001-39957

 

NLS PHARMACEUTICS LTD.

(Translation of registrant’s name into English)

 

The Circle 6

8058 Zurich, Switzerland

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F        Form 40-F

 

 

 

 

 

 

CONTENTS

 

On June 26, 2025, NLS Pharmaceutics Ltd, or the Company, executed an amendment, or the Amendment, to the Securities Purchase Agreement initially executed by and among the purchasers thereto on March 27, 2025, or the Securities Purchase Agreement, relating to a private placement offering. Pursuant to the initial closing contemplated by the Securities Purchase Agreement, the Company issued 1,212,122 preferred shares, par value CHF 0.03 per share, or the Preferred Shares, at a conversion price of $1.65 per share, as well as warrants to purchase 787,880 common shares at an exercise price of $1.80 per share, for aggregate gross proceeds of $2 million.

 

Pursuant to the terms of the Securities Purchase Agreement, the investors had the option to purchase an additional $1 million of Preferred Shares at a purchase price of $1.65 per share, in a subsequent transaction on identical terms as the initial closing. Pursuant to the terms of the Amendment, the investors agreed to purchase preferred participation certificates, or PPCs, in lieu of preferred shares, with the same rights and privileges as the Preferred Shares. Pursuant to the terms of the Securities Purchase Agreement and the Amendment, the Company agreed to issue 606,061 PPCs, as well as warrants to purchase 393,939 common shares at an exercise price of $1.80 per share, for aggregate gross proceeds of $1 million. The second closing occurred on June 27, 2025.

 

In addition, on June 26, 2025, the Company and Alpha Capital Anstalt, or Alpha, entered into a side letter pursuant to which the Company agreed to issue Alpha pre-funded warrants to purchase 485,000 common shares in lieu of the Company’s prior agreement, contained in the Securities Purchase Agreement, to issue Alpha 435,000 preferred shares (or their equivalent) to compensate Alpha for certain price protection issuances and registration obligations.

 

The securities are being offered pursuant to an exemption from the registration requirements under Section 4(a)(2) of the Securities Act of 1933, as amended, or the Securities Act, and Rule 506(b) of Regulation D promulgated thereunder. The securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, once issued, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

 

Press Release

 

On June 30, 2025, the Company issued a press release titled: “NLS Pharmaceutics and Kadimastem Announce Pricing and Closing of $1 Million Equity Financing.” A copy of this press release is furnished herewith as Exhibit 99.5.

 

1

 

 

EXHIBIT INDEX

 

Exhibit No.   Document Description
99.1   Form of Securities Purchase Agreement, dated March 27, 2025, by and between NLS Pharmaceutics and the certain purchasers thereto (filed as Exhibit 99.1 to Form 6-K (File No. 001-39957) filed on March 31, 2025).
99.2   Amendment to Securities Purchase Agreement, dated June 26, 2025, between NLS Pharmaceutics and the certain purchaser thereto.
99.3   Form of Common Warrant.
99.4   Side Letter.
99.5   Form of Pre-Funded Warrant (filed as Exhibit 99.4 to Form 6-K (File No. 001-39957) filed on March 31, 2025).
99.6   Press release titled: “NLS Pharmaceutics and Kadimastem Announce Pricing and Closing of $1 Million Equity Financing.”

 

2

 

 

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, thereunto duly authorized.

 

  NLS Pharmaceutics Ltd.
     
Date: June 30, 2025 By: /s/ Alexander Zwyer
    Name:  Alexander Zwyer
    Title: Chief Executive Officer

 

 

3

 

 

FAQ

What did MIRA (MIRA) announce in its 30 June 2025 Form 8-K?

The company reported pre-clinical data showing SKNY-1 caused ~30% weight loss and reduced nicotine & food cravings in a zebrafish model.

How much weight loss did SKNY-1 achieve according to the filing?

Treated animals lost about 30% of body weight in six days and ended 10% lighter than healthy controls.

Did SKNY-1 affect muscle mass in the study?

No; weight reduction occurred without changes in muscle density, indicating fat loss while preserving lean body mass.

How did SKNY-1 impact nicotine cravings?

The drug significantly reduced nicotine-seeking behaviour, with high-dose animals showing craving levels similar to healthy controls.

Has MIRA completed the acquisition of SKNY Pharmaceuticals?

Not yet; the company is under a definitive agreement to acquire SKNY Pharmaceuticals, but closing terms were not disclosed.
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