Medicus Pharma Ltd. Announces Pricing of $4.2 Million Regulation A Offering
Medicus Pharma (NASDAQ: MDCX) has announced pricing of a $4.2 million Regulation A offering of 1,490,000 units at $2.80 per unit. Each unit includes one common share and one warrant with a 5-year expiration period.
The proceeds will fund the company's Phase 2 proof of concept clinical trial for basal cell carcinoma treatment using their doxorubicin tip loaded dissolvable microarray needle skinpatch. Additional funds may support expanding the exploratory phase 2 trial to a pivotal trial and cover other non-melanoma skin diseases.
The company previously completed a Phase 1 safety study in March 2021, which met its primary objectives and showed complete response in six participants. Their Phase 2 IND clinical protocol, submitted in January 2024, involves a randomized, controlled, double-blind study across nine U.S. sites, targeting 60 patients to evaluate two dose levels of D-MNA versus placebo.
Medicus Pharma (NASDAQ: MDCX) ha annunciato il prezzo di un'offerta di $4,2 milioni ai sensi della Regolamentazione A, composta da 1.490.000 unità a $2,80 per unità. Ogni unità include una azione comune e un warrant con un periodo di scadenza di 5 anni.
I proventi finanzieranno il trial clinico di fase 2 per la prova di concetto nel trattamento del carcinoma basocellulare, utilizzando il loro microarray a ago dissolvibile caricato con doxorubicina. Ulteriori fondi potrebbero supportare l'espansione della fase esplorativa del trial di fase 2 a un trial decisivo e coprire altre malattie cutanee non melanoma.
L'azienda ha precedentemente completato uno studio di sicurezza di fase 1 nel marzo 2021, che ha raggiunto i suoi obiettivi primari e ha mostrato una risposta completa in sei partecipanti. Il loro protocollo clinico IND di fase 2, presentato a gennaio 2024, prevede uno studio randomizzato, controllato e in doppio cieco in nove siti negli Stati Uniti, mirando a 60 pazienti per valutare due livelli di dosaggio di D-MNA rispetto al placebo.
Medicus Pharma (NASDAQ: MDCX) ha anunciado la fijación de precios de una oferta de $4.2 millones bajo la Regulación A de 1,490,000 unidades a $2.80 por unidad. Cada unidad incluye una acción común y un warrant con un período de expiración de 5 años.
Los ingresos financiarán el ensayo clínico de fase 2 para la prueba de concepto en el tratamiento del carcinoma basocelular utilizando su aguja de microarray disoluble cargada con doxorubicina. Fondos adicionales pueden apoyar la expansión del ensayo exploratorio de fase 2 a un ensayo pivotal y cubrir otras enfermedades de la piel no melanoma.
La empresa completó previamente un estudio de seguridad de fase 1 en marzo de 2021, que cumplió con sus objetivos primarios y mostró una respuesta completa en seis participantes. Su protocolo clínico IND de fase 2, presentado en enero de 2024, involucra un estudio aleatorizado, controlado y doble ciego en nueve sitios de EE. UU., con un objetivo de 60 pacientes para evaluar dos niveles de dosis de D-MNA frente al placebo.
메디쿠스 파마 (NASDAQ: MDCX)는 1,490,000 단위의 $4.2 백만 규제 A 공모의 가격을 발표했습니다. 각 단위는 하나의 보통주와 5년 만기의 워런트를 포함합니다.
회사는 2021년 3월에 1상 안전성 연구를 완료했으며, 이는 주요 목표를 달성하고 6명의 참가자에서 완전 반응을 보였습니다. 2024년 1월에 제출된 2상 IND 임상 프로토콜은 미국의 9개 사이트에서 60명의 환자를 대상으로 D-MNA의 두 용량 수준을 위약과 비교하는 무작위, 대조, 이중 맹검 연구를 포함합니다.
Medicus Pharma (NASDAQ: MDCX) a annoncé le prix d'une offre de 4,2 millions de dollars selon la Réglementation A, composée de 1 490 000 unités à 2,80 dollars par unité. Chaque unité comprend une action ordinaire et un warrant d'une durée de 5 ans.
Les recettes financeront l'essai clinique de phase 2 pour la preuve de concept du traitement du carcinome basocellulaire utilisant leur aiguille microarray dissolvable chargée de doxorubicine. Des fonds supplémentaires pourraient soutenir l'expansion de l'essai exploratoire de phase 2 en un essai pivot et couvrir d'autres maladies cutanées non mélanome.
L'entreprise a précédemment complété une étude de sécurité de phase 1 en mars 2021, qui a atteint ses objectifs principaux et a montré une réponse complète chez six participants. Leur protocole clinique IND de phase 2, soumis en janvier 2024, implique une étude randomisée, contrôlée et en double aveugle dans neuf sites aux États-Unis, visant 60 patients pour évaluer deux niveaux de dosage de D-MNA par rapport à un placebo.
Medicus Pharma (NASDAQ: MDCX) hat die Preisgestaltung für ein Angebot in Höhe von 4,2 Millionen US-Dollar gemäß Regulation A für 1.490.000 Einheiten zu je 2,80 US-Dollar bekannt gegeben. Jede Einheit umfasst eine Stammaktie und ein Warrant mit einer Laufzeit von 5 Jahren.
Die Erlöse werden die Phase-2-Konzeptnachweis-Studie zur Behandlung von Basalzellkarzinomen mit ihrer mit Doxorubicin beladenen, löslichen Mikroarray-Nadel-Hautpflaster finanzieren. Zusätzliche Mittel könnten die Erweiterung der explorativen Phase-2-Studie zu einer entscheidenden Studie unterstützen und andere nicht-melanozytäre Hauterkrankungen abdecken.
Das Unternehmen hat zuvor im März 2021 eine Phase-1-Sicherheitsstudie abgeschlossen, die ihre primären Ziele erreicht hat und bei sechs Teilnehmern eine vollständige Reaktion zeigte. Ihr Phase-2-IND-Studienprotokoll, das im Januar 2024 eingereicht wurde, umfasst eine randomisierte, kontrollierte, doppelblinde Studie an neun Standorten in den USA, die 60 Patienten anvisiert, um zwei Dosierungsstufen von D-MNA im Vergleich zu einem Placebo zu bewerten.
- Successful completion of Phase 1 trial with positive efficacy signals
- Phase 2 trial actively recruiting across 9 sites
- $4.2M capital raise to fund clinical development
- Dilutive offering at $2.80 per unit
- Best-efforts basis offering indicates potential execution risk
- Warrants may cause additional future dilution
Insights
Medicus Pharma's $4.2 million Regulation A offering represents a significant capital raise for this small biotech company with a $36.5 million market cap. The offering is priced at $2.80 per unit, representing a 7% discount to the current share price, which typically indicates moderate demand pressure. Each unit includes one common share plus one five-year warrant with the same exercise price.
This offering will dilute existing shareholders by approximately 12.2% based on the 1.49 million new units compared to the company's current capitalization. However, for clinical-stage biotechs, securing development capital remains the primary operational priority, even at the cost of dilution.
The funding is strategically focused on advancing their basal cell carcinoma treatment using a proprietary microneedle skinpatch delivery system through Phase 2 clinical trials. Their Phase 1 study demonstrated both safety and preliminary efficacy with complete responses in several participants, providing a foundation for the current Phase 2 study targeting 60 patients across nine U.S. clinical sites.
For investors, this financing provides Medicus with essential runway to reach potential value-inflection points in their clinical program. The company's microarray needle technology offers a potentially differentiated approach in the non-melanoma skin cancer market, where less invasive treatment options could capture significant market share if proven effective in later-stage trials.
Medicus's doxorubicin-loaded dissolvable microarray needle (D-MNA) technology represents an innovative approach to treating basal cell carcinoma (BCC), the most common form of skin cancer affecting millions annually. The non-invasive patch delivery system could potentially address a significant unmet need for alternatives to surgical excision, the current standard of care.
Their Phase 1 safety and tolerability study yielded promising results, with six participants showing complete response on histological examination. The now-funded Phase 2 trial will evaluate two distinct dosage levels (100 μg and 200 μg) against placebo in a randomized, controlled, double-blind design – a robust clinical methodology appropriate for this stage of development.
The company's strategic decision to potentially expand beyond BCC to other non-melanoma skin diseases represents a prudent pipeline expansion strategy that leverages their core technology platform. This approach could significantly increase market potential while diversifying clinical risk.
The $4.2M funding, while modest for typical oncology drug development, appears adequate for completing their planned Phase 2 proof-of-concept study. If successful, this trial would substantially de-risk the asset and potentially position the company for either a larger financing round or partnership opportunities with established dermatology/oncology players seeking innovative delivery technologies for existing compounds like doxorubicin.
Philadelphia, Pennsylvania--(Newsfile Corp. - March 6, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) (the "Company") today announced the pricing of its Tier II Regulation A offering of 1,490,000 units, on a "best-efforts" basis, at a price of
The common shares are listed on The Nasdaq Capital Market under the symbol "MDCX". The warrants will not trade on any securities exchange. The offering is expected to close on March 10, 2025, subject to customary closing conditions.
The Company intends to use any net proceeds from the offering to fund its Phase 2 proof of concept clinical trial for treatment of basal cell carcinoma using its doxorubicin tip loaded dissolvable microarray needle skinpatch. The Company may also use the net proceeds of the offering to expand its exploratory phase 2 clinical trial to a pivotal trial and/or to expand its trials to cover other non-melanoma skin diseases. The company will use any remaining net proceeds for general corporate purposes and working capital.
An Offering Statement on Form 1-A, as amended (the "Offering Statement"), relating to these securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") and has been qualified. A copy of the Offering Statement, including the preliminary offering circular that forms a part of the Offering Statement, is available on the Company's EDGAR profile at www.sec.gov/edgar.
The securities being offered will not be registered under the United States Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements of the Securities Act and applicable state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any State or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such State or jurisdiction.
For further information contact:
Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com
Jeremy Feffer
LifeSci Advisors
(212) 915-2568
jfeffer@lifesciadvisors.com
About Medicus Pharma Ltd:
Medicus Pharma Ltd. (Nasdaq: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets.
SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd, is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumors cells. The Company has completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company submitted a Phase 2 IND clinical protocol to the FDA in January 2024 for a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) that is expected to randomize up to 60 patients. The study is designed to evaluate the efficacy of two dose of two dose levels (100 and 200 ug) of D-MNA compared to placebo (P-MNA) in subjects with nodular BCC. Patient recruitment is currently underway in nine sites across the United States.
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the timing and completion of the offering and the Company's expected use of the net proceeds of the offering. Forward-looking statements are often but not always, identified by the use of such terms as "may", "on track", "aim", "might", "will", "will likely result", "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target" or the negative and/or inverse of such terms or other similar expressions.
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's public filings on SEDAR+ and on EDGAR, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof, and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Readers are cautioned that the foregoing list is not exhaustive and readers are encouraged to review the Company's long form prospectus accessible on the Company's profile on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/243649
FAQ
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