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Visiox Pharmaceuticals, Inc., a Commercial-Stage Biopharmaceutical Company to be Listed on Nasdaq Through a Business Combination with PowerUp Acquisition Corp.

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Visiox Pharmaceuticals, Inc. (Nasdaq: VSXP) and PowerUp Acquisition Corp. (Nasdaq: PWUP) have announced a definitive agreement for a business combination that will result in Visiox becoming a publicly traded company on the Nasdaq Capital Market. The business combination is expected to close in the first quarter of 2024, and upon closing, the combined company will be named Visiox Holdings, Inc. with its common stock and warrants expected to be listed on Nasdaq under the ticker symbols VSXP and VSXPW, respectively. Visiox's pipeline includes treatments for ocular hypertension, open angle glaucoma, and post-surgical inflammation and pain, addressing highly prevalent disease states in need of new treatment options. The company's CEO, Ryan Bleeks, expressed anticipation that the funds from this transaction will help accelerate the commercialization of key drug candidates.
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Insights

The business combination between Visiox Pharmaceuticals and PowerUp Acquisition Corp. marks a significant event in the biopharmaceutical sector, specifically within the niche of ophthalmic treatments. The anticipated merger is expected to provide Visiox with the capital necessary to accelerate the commercialization of its drug candidates, including an FDA Approved drug and other late-stage candidates. This influx of capital is crucial as it may reduce the time to market for these treatments, potentially leading to an early revenue stream.

Investors should consider the market potential of Visiox's pipeline, particularly given the prevalence of glaucoma globally and the frequency of ocular surgeries in the U.S. The successful commercialization of these treatments could capture a substantial market share. However, the inherent risks of drug development and commercialization, including regulatory hurdles and market competition, remain pertinent considerations.

Furthermore, the leadership continuity with Ryan Bleeks remaining as CEO post-merger is a positive signal, as his extensive industry experience could be pivotal in navigating the company through the complex process of drug commercialization and scaling operations. Stakeholders should monitor the execution of the merger and subsequent integration closely, as these will be critical to realizing the anticipated benefits of the transaction.

The ophthalmic treatment market is a growing segment within the pharmaceutical industry, driven by an aging population and increased incidence of diseases like glaucoma. Visiox's strategic focus on ophthalmic treatments for conditions with high unmet medical needs positions the company to potentially meet the demands of a large patient population. The merger with PowerUp is likely to enhance Visiox's market visibility and investor confidence, given the improved access to capital and the benefits of being a publicly traded entity on Nasdaq.

It's important to note the competitive landscape in which Visiox operates. While their FDA Approved drug and late-stage clinical candidates present significant opportunities, the market is also characterized by rapid technological advancements and the entry of generics. Visiox's ability to differentiate its products, maintain a robust pipeline and execute effective marketing strategies will be crucial for long-term success.

Analysts should also consider the impact of the merger on the stock's liquidity and valuation. The listing of common stock and warrants on Nasdaq under the new ticker symbols could attract more institutional investors and improve trading volumes, potentially leading to increased stock price stability and growth.

From a medical research perspective, the successful commercialization of Visiox's pipeline, including their New Chemical Entity (NCE) and 505(b)(2) products, could represent a significant advancement in the treatment of ocular conditions. The NCE designation implies that the drug consists of active moieties that have not been approved by the FDA previously, which may offer novel mechanisms of action or improved efficacy/safety profiles over existing therapies. The 505(b)(2) pathway can allow for a potentially faster approval process by relying on data from previously approved drugs, which could be advantageous for Visiox's go-to-market strategy.

Given the high prevalence of glaucoma and the volume of ocular surgeries, the impact of introducing effective treatments can be substantial, not only from a business standpoint but also in terms of patient outcomes and quality of life. The medical community will likely follow the progress of Visiox's drug candidates closely, as their success could set a precedent for future treatments in the ophthalmology field.

Tarrytown, NY and New York, NY, Dec. 27, 2023 (GLOBE NEWSWIRE) -- Visiox Pharmaceuticals, Inc. (“Visiox” or the “Company”), a commercial-stage biopharmaceutical company, and PowerUp Acquisition Corp. (“PowerUp”) (Nasdaq: PWUP) today announced the execution of a definitive agreement for a business combination (the “Transaction” or the “Business Combination”) that would result in Visiox becoming a publicly traded company on the Nasdaq Capital Market (“Nasdaq”). The business combination is expected to close in the first quarter of 2024, and upon closing the combined company will be named Visiox Holdings, Inc. with its common stock and warrants expected to be listed on Nasdaq under the ticker symbols VSXP and VSXPW, respectively.

Visiox’s pipeline of an FDA Approved drug candidate, and other late-stage clinical drug candidates, includes treatments for patients with ocular hypertension, open angle glaucoma, and post-surgical inflammation and pain. Visiox’s mission is to develop and commercialize ophthalmic treatments in large markets with high unmet need. Visiox’s pipeline of both New Chemical Entity (NCE) and 505(b)(2) products address highly prevalent disease states in need of new treatment options. Globally, glaucoma affects over 80 million people, and there are over 6 million ocular surgeries in the United States every year.

Upon the closing of the Transaction, Visiox will continue to be led by current CEO, Ryan Bleeks. Mr. Bleeks is a pharmaceutical executive with more than 22 years of ophthalmology industry experience.

“The Visiox/Powerup announcement represents the next major milestone on our journey to provide solutions for patients with ophthalmic conditions in need of new treatment options,” Mr. Bleeks said. “We anticipate that the funds anticipated to be available to us from this transaction will help us accelerate the commercialization of Omlonti, PDP-716, and SDN-037.”

Mr. Suren Ajjarapu, Chairman and CEO of PowerUp, commented on the Transaction as follows: "We are very excited to be taking definitive steps, and planning for the successful combination of PowerUp and Visiox, and for the patients who will benefit from Visiox's innovative ophthalmic therapies. We congratulate Ryan and his team on this milestone achievement."

About Visiox Pharmaceuticals, Inc.

Visiox is a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic therapeutic candidates to address highly prevalent diseases in need of new treatment options. Each day is an opportunity for Visiox to disrupt and revolutionize the current market to maximize patient and physician satisfaction.

OMLONTI® (omidenepag isopropyl ophthalmic solution) 0.002% is a relatively selective prostaglandin E2 (EP2) receptor agonist, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Visiox plans to launch OMLONTI in early 2024, followed by once-daily PDP-716 (brimonidine) 0.35%, positioning the company to become a leader in glaucoma, a disease with significant impact on patients.

PDP-716 (brimonidine) 0.35% is a once daily brimonidine with TearAct technology for glaucoma expected to launch in early 2025. TearActis a patented technology that involves the use of resin microparticles in a complex suspension form to improve the dosing frequency from TID to QD, prolonging the release of drug by reducing the immediate exposure and providing a slow, consistent, and sustained exposure. Glaucoma is the second leading cause of blindness in the world, it is estimated that over 3 million Americans have glaucoma but only half of those know they have it. 

SDN-037 (difluprednate) 0.04% is a twice daily topical difluprednate corticosteroid utilizing TJM (Tight Junction Modulation) micellar platform that involves micelles to modulate the tight junctions (TJs) providing powerful post-surgical control of inflammation in a clear solution enabling convenient dosing with a proven active ingredient. SDN-037 is expected to launch mid-2025. Cataract extraction is the most frequently performed eye surgery in the U.S. It accounts for 70% of all ocular surgeries. 50 million people are projected to have cataracts in the U.S. by 2050.

PDP-716, SDN-037, TearAct, and TJM delivery technology were licensed by Visiox from Sun Pharma Advanced Research Company Ltd. For more information, please visit Visiox Pharma on LinkedIn.

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.

Advisors

Dykema Gossett PLLC serves as legal counsel to PowerUp Acquisition Corp. and Nelson Mullins Riley & Scarborough LLP serves as legal counsel to Visiox Pharmaceuticals, Inc.

Important Information About the Proposed Business Combination and Where to Find It

For additional information on the proposed Transaction, see PowerUp’s Current Report on Form 8-K with respect to the parties mutual execution and delivery of the business combination agreement, which will be filed with the Securities and Exchange Commission. In connection with the Business Combination, PowerUp and Visiox intend to file relevant materials with the SEC, including a registration statement on Form S-4, which will include a proxy statement/prospectus, and will file other documents regarding the proposed Transaction with the SEC. PowerUp’s shareholders and other interested persons are advised to read, when available, the preliminary proxy statement/prospectus and the amendments thereto and the definitive proxy statement and documents incorporated by reference therein filed in connection with the proposed Business Combination, as these materials will contain important information about Visiox and PowerUp and the proposed Business Combination. Promptly after the Form S-4 is declared effective by the SEC, PowerUp will mail the definitive proxy statement/prospectus and a proxy card to each shareholder entitled to vote at the meeting relating to the approval of the business combination and other proposals set forth in the proxy statement/prospectus. Before making any voting or investment decision, investors and shareholders of PowerUp are urged to carefully read the entire registration statement and proxy statement/prospectus, when they become available, and any other relevant documents filed with the SEC, as well as any amendments or supplements to these documents, because they will contain important information about the Business Combination. The documents filed by PowerUp with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov, or by directing a request to PowerUp Acquisition Corp., 188 Grand Street Unit #195, New York, NY 10013, Attention: Secretary; telephone: (347) 313-8109.

Participants in the Solicitation

PowerUp and certain of its directors, executive officers and other members of management and employees may, under SEC rules, be deemed to be participants in the solicitation of proxies from PowerUp’s shareholders in connection with the proposed Transaction. A list of the names of those directors and executive officers and a description of their interests in PowerUp will be included in the proxy statement/prospectus for the proposed Business Combination when available at www.sec.gov. Information about PowerUp’s directors and executive officers and their ownership of PowerUp securities is set forth in PowerUp’s Current Report on Form 8-K, filed with the SEC on August 23, 2023, and any Form 3 or Form 4 filed with the SEC since the date of such filing. Other information regarding the interests of the participants in the proxy solicitation will be included in the proxy statement/prospectus pertaining to the proposed business combination when it becomes available. These documents can be obtained free of charge from the source indicated above.

Visiox and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of PowerUp in connection with the proposed Business Combination. A list of the names of such directors and executive officers and information regarding their interests in the proposed Business Combination will be included in the proxy statement/prospectus for the proposed Business Combination.

Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests will be included in the proxy statement/prospectus filed with the SEC on Form S-4. Shareholders, potential investors and other interested persons should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from the sources indicated above.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements in this press release may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, plans, objectives, expectations and intentions with respect to future operations, products and services, and other statements identified by words such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “believe,” “intend,” “plan,” “projection,” “outlook” or words of similar meaning. These forward-looking statements include, but are not limited to, statements regarding Visiox’s industry and market sizes, expected clinical trial results, future opportunities for Visiox and PowerUp, Visiox’s estimated future results and the potential business combination between PowerUp and Visiox, including the implied enterprise value, the expected Transaction and ownership structure and the likelihood, timing and ability of the parties to successfully consummate the proposed Transaction.

These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by PowerUp and its management and/or Visiox and its management, as the case may be, are inherently uncertain and are subject to significant business, economic and competitive uncertainties and contingencies, many of which are difficult to predict and generally beyond the control of PowerUp and Visiox. Actual results and the timing of events may differ materially from the results anticipated in these 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 Business Combination, including the occurrence of any event, change or other circumstances that could give rise to the termination of the definitive agreement relating to the Business Combination; the inability to complete the Transaction due to the failure to obtain approval of PowerUp’s shareholders, the failure to achieve the minimum cash condition following any redemptions by PowerUp shareholders, or the failure to meet Nasdaq’s initial listing standards in connection with the consummation of the contemplated transactions; costs related to the Transaction; a delay or failure to realize the expected benefits from the Business Combination; risks related to disruption of management’s time from ongoing business operations due to the Business Combination; the impact of any current or new government regulations in the United States affecting Visiox’s operations and the continued listing of Visiox’s securities; inability to achieve successful clinical results or to obtain licensing of third-party intellectual property rights for future discovery and development of Visiox’s projects; failure to commercialize product candidates and achieve market acceptance of such product candidates; failure to protect Visiox’s intellectual property; breaches in data security; risk that Visiox 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, the Annual Report on Form 10-K, filed with the SEC on March 21, 2023, and the proxy statement/prospectus relating to the Business Combination, including those under “Risk Factors” therein, and in PowerUp’s other filings with the SEC. PowerUp and Visiox caution that the foregoing list of factors is not exclusive.

Actual results, performance or achievements may differ materially, and potentially adversely, from any projections and forward-looking statements and the assumptions on which those forward-looking statements are based. 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 as projected financial information and other information are based on estimates and assumptions that are inherently subject to various significant risks, uncertainties and other factors, many of which are beyond the control of PowerUp and Visiox. All information set forth herein speaks only as of the date hereof in the case of information about PowerUp and Visiox or the date of such information in the case of information from persons other than PowerUp or Visiox, and PowerUp and Visiox disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this communication. Forecasts and estimates regarding Visiox’s industry and end markets are based on sources PowerUp and Visiox believe to be reliable, however there can be no assurance these forecasts and estimates will prove accurate in whole or in part. Annualized, pro forma, projected and estimated numbers are used for illustrative purpose only, are not forecasts and do not reflect actual results.

No Offer or Solicitation

This press release is for informational purposes only and shall not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Business Combination. This press release also shall not constitute an offer to sell or the solicitation of an offer to buy any securities pursuant to the Business Combination or otherwise, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.

Corporate Contacts

For Visiox:
Ryan S. Bleeks
Chief Executive Officer
info@visioxpharma.com
914-987-2876

For PowerUp:
Suren Ajjarapu
Chairman and Chief Executive Officer
Suren@SRIRAMAAssociatesLLC.onmicrosoft.com
347-313-8109


FAQ

What is the business combination involving Visiox Pharmaceuticals, Inc. and PowerUp Acquisition Corp.?

Visiox Pharmaceuticals, Inc. and PowerUp Acquisition Corp. have announced a definitive agreement for a business combination that will result in Visiox becoming a publicly traded company on the Nasdaq Capital Market.

When is the business combination expected to close?

The business combination is expected to close in the first quarter of 2024.

What will be the new name of the combined company and its ticker symbols after the business combination?

Upon closing, the combined company will be named Visiox Holdings, Inc. with its common stock and warrants expected to be listed on Nasdaq under the ticker symbols VSXP and VSXPW, respectively.

What does Visiox's pipeline include?

Visiox's pipeline includes treatments for ocular hypertension, open angle glaucoma, and post-surgical inflammation and pain, addressing highly prevalent disease states in need of new treatment options.

Who is the CEO of Visiox Pharmaceuticals, Inc.?

The CEO of Visiox Pharmaceuticals, Inc. is Ryan Bleeks, a pharmaceutical executive with more than 22 years of ophthalmology industry experience.

What are the key drug candidates that Visiox anticipates accelerating the commercialization of?

Visiox anticipates accelerating the commercialization of Omlonti, PDP-716, and SDN-037.

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