Aspire Biopharma, Inc. Signs Letter of Intent to Create a Publicly Listed, Drug Delivery Company Through a Business Combination with PowerUp Acquisition Corp.
Aspire Biopharma, a developer of disruptive drug delivery technology, and PowerUp Acquisition Corp. (Nasdaq: PWUP) have signed a non-binding letter of intent for a potential business combination. The combined public company would be listed on a national securities exchange. Aspire, founded in 2021, focuses on novel delivery mechanisms for FDA-approved drugs, nutraceuticals, and supplements.
Aspire's lead product, Instaprin™, is a fast-acting, pH-neutral aspirin formulation addressing cardiology emergencies and pain management. The company plans to file a 505(b)(2) New Drug Application with the FDA. Aspire's pipeline includes various pharmaceutical and nutraceutical applications, such as a Viagra/Cialis combination and treatments for traumatic brain injury.
The proposed business combination aims to increase Aspire's market visibility and access to capital for product development. Both companies are working towards finalizing a definitive agreement, subject to various conditions and regulatory approvals.
Aspire Biopharma, un sviluppatore di tecnologie innovative per la somministrazione di farmaci, e PowerUp Acquisition Corp. (Nasdaq: PWUP) hanno firmato una lettera di intenti non vincolante per una possibile combinazione aziendale. La nuova azienda pubblica combinata sarà quotata su un mercato nazionale dei titoli. Fondata nel 2021, Aspire si concentra su meccanismi di somministrazione innovativi per farmaci approvati dalla FDA, nutraceutici e integratori.
Il prodotto di punta di Aspire, Instaprin™, è una formulazione di aspirina a rilascio rapido e pH neutro che affronta emergenze cardiologiche e gestione del dolore. L'azienda prevede di presentare una domanda di nuovo farmaco 505(b)(2) presso la FDA. Il portafoglio di Aspire include varie applicazioni farmaceutiche e nutraceutiche, come una combinazione di Viagra/Cialis e trattamenti per lesioni cerebrali traumatiche.
La combinazione commerciale proposta mira ad aumentare la visibilità di Aspire sul mercato e l'accesso al capitale per lo sviluppo dei prodotti. Entrambe le aziende stanno lavorando per finalizzare un contratto definitivo, soggetto a varie condizioni e approvazioni normative.
Aspire Biopharma, un desarrollador de tecnologías innovadoras para la entrega de medicamentos, y PowerUp Acquisition Corp. (Nasdaq: PWUP) han firmado una carta de intención no vinculante para una posible combinación empresarial. La empresa pública combinada se cotizará en una bolsa de valores nacional. Fundada en 2021, Aspire se centra en mecanismos de entrega novedosos para medicamentos aprobados por la FDA, nutracéuticos y suplementos.
El producto principal de Aspire, Instaprin™, es una formulación de aspirina de acción rápida y pH neutro que aborda emergencias cardiológicas y el manejo del dolor. La compañía planea presentar una solicitud de nuevo medicamento 505(b)(2) ante la FDA. La cartera de Aspire incluye diversas aplicaciones farmacéuticas y nutracéuticas, como una combinación de Viagra/Cialis y tratamientos para lesiones cerebrales traumáticas.
La combinación empresarial propuesta tiene como objetivo aumentar la visibilidad de Aspire en el mercado y el acceso a capital para el desarrollo de productos. Ambas empresas están trabajando para finalizar un acuerdo definitivo, sujeto a diversas condiciones y aprobaciones regulatorias.
Aspire Biopharma는 혁신적인 약물 전달 기술 개발업체로, PowerUp Acquisition Corp. (Nasdaq: PWUP)와 비구속적인 합의서에 서명하여 잠재적인 사업 결합을 논의하고 있습니다. 결합된 공기업은 국립 증권 거래소에 상장될 예정입니다. 2021년에 설립된 Aspire는 FDA 승인 약물, 건강 보조 식품 및 영양소에 대한 혁신적인 전달 메커니즘에 집중하고 있습니다.
Aspire의 주력 제품인 Instaprin™은 심장 응급 상황 및 통증 관리를 위한 빠르게 작용하는 pH 중성 아스피린 제형입니다. 이 회사는 FDA에 505(b)(2) 신약 신청서를 제출할 계획입니다. Aspire의 파이프라인에는 비아그라/시알리스 조합 및 외상성 뇌 손상 치료와 같은 다양한 제약 및 건강 보조 식품 응용 프로그램이 포함되어 있습니다.
제안된 사업 결합은 Aspire의 시장 가시성과 제품 개발을 위한 자본 접근성을 높이는 것을 목표로 합니다. 두 회사는 다양한 조건 및 규제 승인을 조건으로 하는 최종 계약을 체결하기 위해 협력하고 있습니다.
Aspire Biopharma, un développeur de technologies innovantes pour l'administration de médicaments, et PowerUp Acquisition Corp. (Nasdaq: PWUP) ont signé une lettre d'intention non contraignante pour une éventuelle combinaison d'entreprises. La société publique combinée sera cotée sur une bourse nationale. Fondée en 2021, Aspire se concentre sur des mécanismes de délivrance novateurs pour les médicaments approuvés par la FDA, les nutraceutiques et les compléments alimentaires.
Le produit phare d'Aspire, Instaprin™, est une formulation d'aspirine à action rapide et pH neutre qui traite les urgences cardiologiques et la gestion de la douleur. L'entreprise prévoit de soumettre une demande de nouveau médicament 505(b)(2) à la FDA. Le pipeline d'Aspire comprend diverses applications pharmaceutiques et nutraceutiques, telles qu'une combinaison de Viagra/Cialis et des traitements pour les traumatismes crâniens.
La combinaison d'entreprise proposée vise à accroître la visibilité d'Aspire sur le marché et l'accès au capital pour le développement de produits. Les deux entreprises travaillent à la finalisation d'un accord définitif, sous réserve de diverses conditions et approbations réglementaires.
Aspire Biopharma, ein Entwickler von innovativen Medikamentenabgabetechnologien, und PowerUp Acquisition Corp. (Nasdaq: PWUP) haben ein nicht verbindliches Absichtsschreiben für eine potenzielle Unternehmenszusammenlegung unterzeichnet. Das fusionierte Unternehmen wird an einer nationalen Wertpapierbörse gelistet. Aspire, 2021 gegründet, konzentriert sich auf neuartige Abgabeformen für von der FDA zugelassene Medikamente, Nutraceuticals und Nahrungsergänzungsmittel.
Das Hauptprodukt von Aspire, Instaprin™, ist eine schnell wirksame, pH-neutrale Aspirin-Formulierung, die auf kardiologische Notfälle und Schmerzmanagement abzielt. Das Unternehmen plant, einen 505(b)(2) New Drug Application bei der FDA einzureichen. Das Portfolio von Aspire umfasst verschiedene pharmazeutische und nutraceutical Anwendungen, wie die Kombination Viagra/Cialis und Behandlungen für traumatische Hirnverletzungen.
Die vorgeschlagene Unternehmenszusammenlegung zielt darauf ab, die Marktpräsenz von Aspire und den Zugang zu Kapital für die Produktentwicklung zu erhöhen. Beide Unternehmen arbeiten daran, einen endgültigen Vertrag zu finalisieren, der verschiedenen Bedingungen und regulatorischen Genehmigungen unterliegt.
- Potential listing on a national securities exchange through business combination with PWUP
- Novel drug delivery technology with patent protection
- Lead product Instaprin™ addresses cardiology emergencies and pain management
- Planned 505(b)(2) NDA filing for Instaprin™, potentially accelerating approval process
- Diverse development pipeline including Viagra/Cialis combination and other treatments
- Early-stage company with no marketed products yet
- Business combination subject to various contingencies and regulatory approvals
- No guarantee of definitive agreement or transaction completion
Insights
The announcement of Aspire Biopharma's potential business combination with PowerUp Acquisition Corp. marks a significant milestone for the company. This move towards becoming a publicly listed entity could have substantial implications for Aspire's future growth and market position.
Key financial considerations include:
- Increased access to capital: As a public company, Aspire would likely have better access to funding for its R&D pipeline and commercialization efforts.
- Enhanced visibility: Listing on a national securities exchange could attract more institutional investors and analysts, potentially leading to higher valuations.
- Regulatory scrutiny: The transition to a public company will require Aspire to meet stringent reporting and compliance standards, which may increase operational costs.
While the LOI is non-binding, the market's reaction to this news could be positive, given Aspire's innovative drug delivery technology and its potential applications across various therapeutic areas. However, investors should be cautious as the deal is not yet finalized and subject to various contingencies.
The financial impact of this move will largely depend on the terms of the final agreement and Aspire's ability to capitalize on its expanded access to capital markets to accelerate its product development and commercialization strategies.
Aspire Biopharma's drug delivery technology presents an intriguing advancement in pharmaceutical administration. The company's focus on rapid sublingual absorption could potentially revolutionize emergency treatments and improve patient outcomes in critical situations.
Key points to consider:
- Novel absorption pathway: Bypassing the gastrointestinal tract and liver could significantly reduce first-pass metabolism, potentially allowing for lower doses and fewer side effects.
- Broad application potential: The technology's versatility, as evidenced by Aspire's diverse pipeline, suggests it could be applied to a wide range of therapeutics beyond just aspirin.
- Regulatory pathway: The planned 505(b)(2) NDA for Instaprin™ is a strategic choice that could expedite the approval process and reduce development costs.
The company's approach to improving established drugs like aspirin and Viagra/Cialis through enhanced delivery mechanisms is particularly noteworthy. If successful, this could lead to improved efficacy and patient compliance across multiple therapeutic areas.
However, it's important to note that Aspire is still in the early stages of development. While their technology shows promise, rigorous clinical trials will be necessary to prove its safety and efficacy. The success of their lead candidate, Instaprin™, will be a critical indicator of the technology's potential.
The proposed business combination between Aspire Biopharma and PowerUp Acquisition Corp. presents several legal considerations that investors should be aware of:
- Regulatory approvals: The transaction will require SEC review and approval from a national securities exchange, which can be a complex and time-consuming process.
- Intellectual property: Aspire's patent portfolio, including the recent USPTO application, is important to its value proposition. The strength and defensibility of these patents will be a key factor in the company's long-term success.
- Disclosure requirements: As a public company, Aspire will need to comply with extensive disclosure regulations, including detailed information about its technology, pipeline and financial performance.
- Contingencies: The non-binding nature of the LOI means that the deal could still fall through. Investors should be cautious until a definitive agreement is reached.
The 505(b)(2) regulatory pathway for Instaprin™ is a strategic choice that could streamline the approval process. However, it's important to note that this pathway still requires substantial evidence of safety and efficacy.
Aspire's international patent filings indicate a global strategy, which could provide broader market opportunities but also introduces complexities in terms of international regulatory compliance and IP protection.
Overall, while the proposed transaction offers potential benefits, it also introduces new legal and regulatory challenges that Aspire will need to navigate carefully as it transitions to a public company.
Humacao, PR and New York, NY, July 31, 2024 (GLOBE NEWSWIRE) -- Aspire Biopharma, Inc. (“Aspire” or the “Company”), a developer of a multi-faceted patent protected disruptive drug delivery mechanism technology, and PowerUp Acquisition Corp. (Nasdaq: PWUP), a Nasdaq Global Market® listed special purpose acquisition company ("PowerUp"), today announced that they have signed a non-binding letter of intent ("LOI") for a potential business combination ("Business Combination"). Under the terms of the LOI, following the consummation of the Business Combination, the combined public company would be listed on a national securities exchange.
Aspire Biopharma, Inc. is a privately held, early-stage biopharmaceutical technology company founded in 2021. The Company is engaged in the business of developing and marketing a disruptive technology for novel delivery mechanisms for “do no harm” FDA approved drugs, nutraceuticals and supplements. Aspire has developed and acquired technologies that are a Novel Soluble Formulation which address emergencies and drug efficacy, dosage management, patient compliance and safety and rapid response and absorption time when required and desired.
In March 2023, the Company filed application number 63/456,290 with the United States Patent and Trademark Office (“USPTO”) with the goal of securing patent protection for its new technology and aspirin formulation. This technology is expected to facilitate development of any number of products in a soluble, PH neutral, fast acting powder form using Aspire’s patented formulation, and “trade secret” process. Aspire’s drug delivery utilizes a new mechanism of action (absorption pathway) which allows for instant absorption in the mouth. The benefits of “instant absorption” are to provide nearly instant treatment impact and also allows high dose absorption. The Company has recently broadened its patent portfolio internationally and is in the process of filing additional patents covering a new set of drugs currently under development.
Aspire’s patented and patent pending delivery system includes components specifically formulated to allow rapid sublingual absorption of drugs directly into the blood stream, by passing the gastrointestinal tract and liver thus mitigating unwanted toxicity of this critical organ.
Instaprin™: “Instant Aspirin” - Aspire’s Expected Launch Product
Aspire had historically focused on the delivery of aspirin, which may be the most studied and accepted analgesic and anti-inflammatory. However, current aspirin applications have limitations due to side effects from acidity.
Instaprin™, which addresses cardiology emergencies and pain management, is a granular or powder formulation of a soluble, Ph neutral, fast acting aspirin. Benefits of “instant absorption” aspirin are to stop heart attack and stroke; allow high dose absorption for pain management including quick headache relief, post-surgery, cancer pain management, and general pain relief. Aspire currently plans to file a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration (“FDA”) for Instaprin™. The 505(b)(2) pathway specifically benefits new drugs that are similar to already approved drugs but have slight variations in formulation or administration routes. Aspire intends to reference the safety and efficacy data of the original innovator drug which can accelerate the approval process and reduce associated costs.
Aspire’s Development Pipeline
In addition to the Company’s lead candidate Instaprin™, Aspire has numerous pharmaceutical and nutraceutical applications under development in the following areas, including but not limited to a proprietary Viagra/Cialis combination product which is faster acting and requires decreased dosages with the benefit of a longer half-life, various bi-hormonal drugs such as testosterone, estrogen and weight loss drugs, traumatic brain injury drugs, and thyroid drugs, among others.
“Pursuing a listing on a national securities exchange has always been a long-term objective of ours,” said Kraig Higginson, CEO of Aspire. "We expect this business combination to increase Aspire's visibility in the marketplace, and provide heightened access to capital to develop a large portfolio of products that can provide critical medications, nutraceuticals and supplements. Our next step is to negotiate and execute a definitive agreement, a process which is already underway."
Suren Ajjarapu, Chief Executive Officer of Powerup Acquisition Corp., said “It is gratifying to be working with Mr. Higginson to help accelerate Aspire Biopharma’s growth strategy. This transaction will create for our PowerUp investors the opportunity to participate in Aspire Biopharma's expected growth. We look forward to working with Aspire Biopharma to close the proposed business combination.”
Aspire Biopharma and PowerUp intend to finalize their definitive business combination agreement in the coming weeks and will announce additional details at that time. There can be no assurance that a definitive agreement will be entered into or that the proposed transaction will be consummated on the terms or timeframe currently contemplated, or at all. Any such transaction would be subject to various contingencies and conditions, including the Aspire Biopharma's requisite investor consents, third party consents and regulatory review, including from the Securities and Exchange Commission ("SEC") and a national securities exchange.
Advisors
Dykema Gossett, PLLC serves as legal counsel to PowerUp Acquisition Corp.
Sichenzia Ross Ference Carmel LLP serves as legal counsel to Aspire BioPharma, Inc.
About Aspire Biopharma, Inc.
Headquartered in Humacao, Puerto Rico, Aspire Biopharma has developed a disruptive technology through a Novel Soluble Formulation which addresses emergencies, drug efficacy, dosage management, and response time. For more information, please visit www.aspirebiolabs.com.
About PowerUp Acquisition Corp.
PowerUp Acquisition Corp. is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. The management team is led by Mr. Surendra Ajjarapu, Chief Executive Officer.
Additional Information about the Proposed Transaction and Where to Find It
This communication relates to the potential Business Combination involving Aspire and PowerUp. If a legally binding definitive agreement with respect to the potential Business Combination is executed, PowerUp intends to file with the SEC a Current Report on Form 8-K with respect to the execution of the definitive agreement and a registration statement on Form S-4 (the "Registration Statement"), which will include a preliminary proxy statement/prospectus. This communication is not a substitute for the Registration Statement, the definitive proxy statement/final prospectus or any other document that PowerUp or Aspire has filed or will file with the SEC or send to its shareholders or investors in connection with the potential Business Combination. This document does not contain all the information that should be considered concerning the potential Business Combination and other matters and is not intended to form the basis for any investment decision or any other decision in respect of such matters.
BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, POWERUP’S SHAREHOLDERS AND OTHER INTERESTED PARTIES ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS WHEN IT BECOMES AVAILABLE AND ANY AMENDMENTS THERETO AND ANY OTHER DOCUMENTS FILED BY POWERUP WITH THE SEC IN CONNECTION WITH THE POTENTIAL BUSINESS COMBINATION OR INCORPORATED BY REFERENCE THEREIN IN THEIR ENTIRETY BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE POTENTIAL BUSINESS COMBINATION BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE POTENTIAL BUSINESS COMBINATION AND THE PARTIES TO THE POTENTIAL BUSINESS COMBINATION.
After the Registration Statement is declared effective, the definitive proxy statement will be mailed to shareholders of PowerUp as of a record date to be established for voting on the potential Business Combination. Additionally, PowerUp will file other relevant materials with the SEC in connection with the potential Business Combination. Copies of the Registration Statement, the definitive proxy statement/final prospectus and all other relevant materials for the potential Business Combination filed or that will be filed with the SEC may be obtained, when available, free of charge at the SEC's website at www.sec.gov. PowerUp’s shareholders may also obtain copies of the definitive proxy statement/prospectus, when available, without charge, by directing a request to PowerUp, 188 Grand Street, #195 New York, NY 10013, or by telephone at (347) 313-8109.
Participants in the Solicitation of Proxies
PowerUp and Aspire and certain of their respective directors and officers may be deemed participants in the solicitation of proxies from PowerUp's shareholders in connection with the proposed Business Combination. PowerUp’s shareholders and other interested persons may obtain, without charge, more detailed information regarding the names and interests in the proposed Business Combination of PowerUp's directors and officers in PowerUp's filings with the SEC, including PowerUp’s initial public offering prospectus, which was filed with the SEC on February 22, 2022, and PowerUp's subsequent annual reports on Form 10-K and quarterly reports on Form 10-Q. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to PowerUp's shareholders in connection with the Business Combination and a description of their direct and indirect interests will be included in the definitive proxy statement/prospectus relating to the proposed Business Combination when it becomes available.
Shareholders, potential investors and other interested persons should read the proxy statement/prospectus carefully before making any voting or investment decisions. You may obtain free copies of these documents from the sources indicated above.
No Offer or Solicitation
This communication is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the potential Business Combination or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. The potential Business Combination is expected to be implemented solely pursuant to a legally binding definitive agreement which is expected to be filed as an exhibit to a Current Report on Form 8-K by PowerUp, and which is expected to contain the material terms and conditions of the potential Business Combination. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended, or an exemption therefrom.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements made in this communication may be considered "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of words such as "estimate," "projects," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "would," "should," "future," "propose," "potential," "target," "goal," "objective," "outlook" and variations of these words or similar expressions (or the negative versions of such words or expressions). These forward-looking statements include, but are not limited to, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of the combined public company, including as they relate to the potential Business Combination and related transactions, pricing and market opportunity, the completion of the potential Business Combination and related transactions, the level of redemptions by PowerUp’s public shareholders and the timing of the completion of the proposed Business Combination, including the anticipated closing date of the proposed Business Combination and the use of the cash proceeds therefrom. These statements are based on various assumptions, whether or not identified in this communication, and on the current expectations of PowerUp's and Aspire’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability.
These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of the parties, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: the inability to meet the closing conditions to the proposed Business Combination, including the occurrence of any event, change or other circumstances that could give rise to the termination of any definitive agreement relating to the Business Combination; the inability to complete the proposed Business Combination due to the failure to obtain approval of PowerUp’s shareholders, the failure to achieve any minimum cash condition following any redemptions by PowerUp shareholders, or the failure to meet initial listing standards in connection with the consummation of the proposed Business Combination; costs related to the proposed Business Combination; a delay or failure to realize the expected benefits from the proposed Business Combination; risks related to disruption of management’s time from ongoing business operations due to the proposed Business Combination; the impact of any current or new government regulations affecting Aspire’s operations; failure to protect intellectual property; breaches in data security; the risk that Aspire may not be able to develop and maintain effective internal controls; unfavorable changes to the regulatory environment; and other risks and uncertainties indicated in PowerUp’s final prospectus dated February 17, 2022, and filed with the SEC on February 22, 2022, for its initial public offering, in PowerUp’s most recent Annual Report on Form 10-K, and in PowerUp’s other filings with the SEC. PowerUp and Aspire caution that the foregoing list of factors is not exhaustive.
There can be no assurance that the data contained herein is reflective of future performance to any degree. You are cautioned not to place undue reliance on forward-looking statements as a predictor of future performance. All information set forth herein speaks only as of the date hereof, and PowerUp and Aspire disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this communication, except as required by law.
Aspire Biopharma, Inc. Contact:
TraDigital IR
Kevin McGrath
+1-646-418-7002
kevin@tradigitalir.com
SOURCE: PowerUp Acquisition Corp.
FAQ
What is the purpose of Aspire Biopharma's business combination with PowerUp Acquisition Corp (PWUP)?
What is Aspire Biopharma's lead product and its potential benefits?
How does Aspire Biopharma plan to seek FDA approval for Instaprin™?
What other products are in Aspire Biopharma's development pipeline?
