• Owner of SYNDROS^®(dronabinol), the only US-based FDA approved CII Tetrahydrocannabinol (THC), a liquid cannabinoid used in adults to treat: Chemotherapy Induced Nausea and Vomiting (CINV) associated in adult patients who have failed to respond adequately to conventional antiemetic treatments; and Anorexia associated with weight loss in adult patients with Acquired Immune Deficiency Syndrome (AIDS)
• 83,000 square foot manufacturing facility in Texas is FDA registered and licensed by the U.S. DEA to manufacture Schedule I to III controlled substances in a cGMP facility, with a DEA-exemption permit to export globally
• Five FDA-registered Investigational New Drugs
• Seminal patents in organic and synthetic cannabinoids
• Pending license approval to manufacture psychedelic pharmaceuticals

JUPITER, FL and ROUND ROCK, TX / ACCESSWIRE / December 9, 2021 /Jupiter Wellness, Inc. (NASDAQ:JUPW), announced today it has signed a definitive agreement to acquire Next Frontier Pharmaceuticals, Inc. (“Next Frontier Pharmaceuticals”), through a merger with a subsidiary of Jupiter Wellness. Under the terms of the transaction, Next Frontier Pharmaceuticals’ stockholders will receive shares of Jupiter Wellness convertible preferred stock that will be convertible into the common stock of Jupiter Wellness and no cash. The transaction, which has been unanimously approved by the board of directors of both companies, is expected to close in the first quarter of 2022.

Upon the closing of the transaction, the combined company intends to become a leading drug developer and manufacturer of pharmaceutical cannabinoids and psychedelics with a growing portfolio of drug products and intellectual property.

Next Frontier Pharmaceuticals owns the only U.S.-based FDA approved CII Tetrahydrocannabinol (THC), a liquid cannabinoid, SYNDROS®, used in adults to treat: CINV in adult patients who have failed to respond adequately to conventional antiemetic treatments; and Anorexia associated with weight loss in adult patients with AIDS. Next Frontier Pharmaceuticals is also pursuing a 505(b)(2) approval pathway with the FDA for several Investigational New Drugs (INDs) for indications including opioid withdrawal, pain, migraines, and nausea and vomiting associated with chemotherapy. The Company’s 83,000 square foot manufacturing facility in Texas is FDA registered and licensed by the U.S. DEA to manufacture Schedule I to III controlled substances in a cGMP facility. The facility currently operates as a contract manufacturer of active pharmaceutical ingredients (APIs). Next Frontier Pharmaceuticals also has a robust portfolio of patents and patents pending on organic and synthetic cannabinoids.

“Jupiter Wellness was established with a vision to become a leading pharmaceutical cannabinoid company. Today, with the signing of the merger agreement with Next Frontier Pharmaceuticals, we will have the foundational drug development and formulation team and manufacturing assets to become such a leader. With its industry-leading cannabinoid platform, innovative products, and pipeline, we strongly believe that Next Frontier Pharmaceuticals positions us well for long-term stockholder value creation,” said Brian John, Chief Executive Officer of Jupiter Wellness. “We are joining with a world-class team of executives and board members with a strong track record of execution that share a passion for pursuing differentiated therapies based on cannabinoids and psychedelics.”

“With assets that have been developed over the last 10 years, Next Frontier Pharmaceuticals believes it is well positioned to have a leadership position in cannabinoid science, including the only U.S.-based FDA approved CII Tetrahydrocannabinol (THC), a liquid cannabinoid and one of the largest captive synthetic cannabinoid manufacturing facilities in the world. With our FDA approved SYNDROS® drug, we intend to expand our platform of drug products to create novel therapies for pain, inflammation, and insomnia, among other ailments. Given our focus, we believe that Jupiter Wellness is an ideal growth partner that is committed to supporting our commercial efforts, as well as ongoing clinical and research programs,” said Shannon Soqui, Executive Chairman of Next Frontier Pharmaceuticals. “We have a shared vision of developing and commercializing innovative medicines that utilize cannabinoids and psychedelics. As a public company, Next Frontier Pharmaceuticals believes it will now have the resources and opportunity to reach and impact more patients through a broader portfolio of cannabinoid-focused therapies than ever before.”

Creates a Leader in Pharmaceutical Cannabinoid Drug Development and Manufacturing

• Drug Development Platform Expansion: The transaction enables the expansion of drug development and formulation capabilities focused on cannabinoids and psychedelics. With SYNDROS®, Next Frontier Pharmaceuticals will attempt to extend the formulation for use for pain and inflammation, among other indications. The collective Jupiter Wellness and Next Frontier Pharmaceuticals teams will bring highly complementary expertise to a pro forma pipeline of nine clinical development programs for pain and migraines, among other indications.
• Synthetic Cannabinoid and Psychedelic Manufacturing: Creates the leading platform for active pharmaceutical ingredient manufacturing based on synthetic cannabinoids and psychedelics. With a DEA-exemption permit to export globally, and with product manufactured in a cGMP FDA registered facility that holds both DEA licenses and Board of Pharmacy permits, the platform is uniquely positioned for growth given the difficulty, cost, and time to obtain such capabilities.
• Seminal Patents in Organic and Synthetic Cannabinoids: Next Frontier Pharmaceuticals has two patents that have received notices of allowance including a foundational method of cannabigerol (CBG) synthesis and a unique broad spectrum hemp powder, and 14 patents pending surrounding cannabinoid synthesis and cannabis production methodologies.
• Exceptional Management Team and Board: The Next Frontier Pharmaceutical team includes a roster of Fortune 500 executives with a long history in pharmaceuticals and cannabinoids, as well as public company management, reporting and corporate governance experience, and a board advisor that was formerly at GW Pharmaceuticals.
• Expected to Deliver Substantial Stockholder Value: The combination is expected to provide accelerated revenue and earnings growth and to be accretive in the first full year of combined operations and substantially accretive thereafter.

Transaction Terms
Under the terms of the agreement, Next Frontier Pharmaceuticals’ stockholders will be entitled to receive convertible stock of Jupiter Wellness that is convertible into 65,000,000, shares of Jupiter Wellness common stock and no cash at the closing of the transaction. Such shares will be subject to a six-month standard lock-up agreement. In connection with the transaction, Jupiter Wellness has loaned $10.2 million to Next Frontier Pharmaceuticals under a note secured by Next Frontier Pharmaceuticals’ Texas-based synthetic cannabinoid manufacturing facility.

Closing Conditions
The transaction has been unanimously approved by the Boards of Directors of both companies and is subject to the approval of Jupiter Wellness stockholders and other customary closing conditions, including regulatory approvals. Subject to the satisfaction or waiver of the closing conditions, the transaction is expected to close in the first quarter of 2022.

Conference Call Details
The two companies will host a conference call on Thursday, December 9th at 4:00 PM ET to discuss this transaction. The live webcast may be accessed from the Investors section of Jupiter’s website at www.jupiterwellness.com. Please connect prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing 561-462-3946. An archived version of the conference call will be available for at least one week in the Investors section of Jupiter’s website at www.jupiterwellness.com.

Advisors
Lucosky Brookman LLP, led by Joe Lucosky and Adele Hogan, is serving as legal counsel to Jupiter Wellness.

About Jupiter Wellness
Jupiter Wellness, Inc. (NASDAQ:JUPW) is a leading developer of pharmaceutical cannabinoids focused on skincare therapeutics and treatments. The Company’s product pipeline incorporates cannabidiol (CBD) to address indications including psoriasis, eczema, burns, herpes cold sores, and skin cancer. Jupiter generates revenue from a growing line of proprietary over-the-counter skincare products including its CaniSun sunscreen and other wellness brands sold through www.cbdcaring.com. For additional information, please visit www.jupiterwellness.com.

About Next Frontier Pharmaceuticals
Next Frontier Pharmaceuticals owns the only U.S.-based FDA approved cannabinoid (SYNDROS®), and one of the largest captive synthetic cannabinoid manufacturing facilities in the U.S. SYNDROS® is FDA approved as a prescription drug for the treatment of CINV in cancer patients and loss of appetite in AIDS patients. Next Frontier Pharmaceuticals is also pursuing a 505(b)(2) approval pathway with the FDA for several Investigational New Drugs (INDs) for indications including opioid withdrawal, pain, migraines, and nausea and vomiting associated with chemotherapy. The Company’s 83,000 square foot manufacturing facility in Texas is licensed by the U.S. DEA to manufacture Schedule I to III controlled substances, holds Board of Pharmacy permits, is registered by the FDA, and is cGMP compliant. The facility has received millions in manufacturing infrastructure investments and currently operates as a contract manufacturer of active pharmaceutical ingredients (APIs) for global distribution. Next Frontier also has a robust portfolio of patents and patents pending on organic and synthetic cannabinoids.

Jupiter Wellness Media Contact:
Phone: 561-244-7100
Email: [email protected]

Jupiter Wellness Investor Contact:
Phone: 561-244-7100
Email: [email protected]

Next Frontier Pharmaceuticals Media Contact:
Roiby Gonzalez, Media Director
Email: [email protected]

Next Frontier Pharmaceuticals Investor Contact:
Susie Wiest, Corporate Administration
Email: [email protected]

Forward-Looking Statements
This communication contains forward-looking statements regarding Jupiter Wellness, including, but not limited to, statements related to the proposed acquisition of Next Frontier Pharmaceuticals and the anticipated timing, results and benefits thereof, including the potential for Jupiter Wellness to accelerate its growth and cannabinoid leadership, and for the acquisition to provide long-term growth opportunities to create shareholder value; and other statements that are not historical facts. You can generally identify forward-looking statements by the use of forward-looking terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “explore,” “evaluate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” or “will,” or the negative thereof or other variations thereon or comparable terminology. These forward-looking statements are based on each of the companies’ current plans, objectives, estimates, expectations, and intentions and inherently involve significant risks and uncertainties, many of which are beyond Jupiter Wellness’ control. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: Jupiter Wellness’ and Next Frontier Pharmaceuticals’ ability to complete the acquisition on the proposed terms or on the anticipated timeline, or at all, including risks and uncertainties related to securing the necessary regulatory and shareholder approvals, and satisfaction of other closing conditions to consummate the acquisition; the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive transaction agreement relating to the proposed transaction; risks related to diverting the attention of management from ongoing business operations; failure to realize the expected benefits of the acquisition; significant transaction costs and/or unknown or inestimable liabilities; the risk of shareholder litigation in connection with the proposed transaction, including resulting expense or delay; the risk that Next Frontier Pharmaceuticals’ business will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; risks related to future opportunities and plans for the combined company, including the uncertainty of expected future regulatory filings, financial performance and results of the combined company following completion of the acquisition; Next Frontier Pharmaceuticals’ dependence on the successful commercialization of SYNDROS and the uncertain market potential of SYNDROS; pharmaceutical product development and the uncertainty of clinical success; the regulatory approval process, including the risks that the combined company may be unable to submit anticipated regulatory filings on the timeframe anticipated, or at all, or that the combined company may be unable to obtain regulatory approvals of any of its product candidates, and SYNDROS for additional indications, in a timely manner or at all; disruption from the proposed acquisition, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; effects relating to the announcement of the acquisition or any further announcements or the consummation of the acquisition on the market price of Jupiter Wellness’ common stock; the possibility that, if Jupiter Wellness does not achieve the perceived benefits of the acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of Jupiter Wellness’ common stock could decline; potential litigation associated with the possible acquisition; regulatory initiatives and changes in tax laws; market volatility; and other risks and uncertainties affecting Jupiter Wellness and Next Frontier Pharmaceuticals and, including those described from time to time under the caption “Risk Factors” and elsewhere in Jupiter Wellness’ Securities and Exchange Commission (SEC) filings and reports, including Jupiter Wellness’ Annual Report on Form 10-K for the year ended December 31, 2020 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, and future filings and reports by Jupiter Wellness. In addition, the extent of the impact on the combined company’s ability to generate sales of and revenues from its approved products, execute on new product launches, its clinical development and regulatory efforts, its corporate development objectives, and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time. Moreover, other risks and uncertainties of which the combined company is not currently aware may also affect each of the companies’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. Investors are cautioned that forward-looking statements are not guarantees of future performance. The forward-looking statements made in this communication are made only as of the date hereof or as of the dates indicated in the forward-looking statements and reflect the views stated therein with respect to future events at such dates, even if they are subsequently made available by Jupiter Wellness on its website or otherwise. Jupiter Wellness undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

Additional Information and Where to Find It
In connection with the proposed transaction, Jupiter Wellness intends to file a proxy and registration statement with the SEC and may also file other relevant documents with the SEC regarding the proposed transaction. The definitive proxy statement (if and when available) will be mailed to shareholders of Jupiter Wellness. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT (WHICH WILL INCLUDE AN EXPLANATORY STATEMENT IN RESPECT OF THE MERGER AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the proxy statement (if and when available) and other documents containing important information about Jupiter Wellness, Next Frontier Pharmaceuticals and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Jupiter Wellness will be available free of charge on Jupiter Wellness’ website at www.jupiterwellness.com.

Participants in the Solicitation
Jupiter Wellness, Next Frontier Pharmaceuticals, their respective directors and certain of their executive officers and other employees may be deemed to be participants in the solicitation of proxies from Jupiter Wellness’ security holders in connection with the proposed transaction. Information about Jupiter Wellness’ directors and executive officers is set forth in Jupiter Wellness’ proxy statement on Schedule 14A for its 2021 Annual General Meeting, which was filed with the SEC on November 3, 2021 and subsequent statements of beneficial ownership on file with the SEC. Additional information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of Jupiter Wellness security holders in connection with the proposed transaction, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the proxy statement when it is filed with the SEC.

No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made in the United States absent registration under the U.S. Securities Act of 1933, as amended (Securities Act), or pursuant to an exemption from, or in a transaction not subject to, such registration requirements. The Jupiter Wellness securities to be issued in the proposed transaction are anticipated to be issued in reliance upon the registration statement.

SOURCE: Jupiter Wellness, Inc.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

• THCVHS combined with netarsudil (Rhopressa®) achieves an average maximum intraocular pressure (IOP) reduction of 32.4% and maintains an average IOP reduction of 26.5% at 9 hours, significantly better than any single drug or combination tested
• THCVHS demonstrates superior IOP-lowering and duration relative to glaucoma standard of care, latanoprost

San Diego, Calif, May 17, 2021 (GLOBE NEWSWIRE) — Skye Bioscience, Inc. (OTCQB: SKYE) (“SKYE” or the “Company”), a biopharmaceutical company developing proprietary, synthetic cannabinoid-derived molecules to treat glaucoma and other diseases with significant unmet need, announced that in a preclinical study assessing intraocular pressure (IOP)-lowering effects of its novel prodrug, THCVHS combined with netarsudil demonstrated the most significant IOP-lowering effects and duration of activity compared to all other tested single and combined treatments. Data from this study also highlighted THCVHS’ superior IOP-lowering capability and duration of activity as a single agent compared to the current standard of care for the treatment of glaucoma, latanoprost.

Elevated IOP is a key risk factor in the progression of glaucoma and the result of fluid build-up in the anterior compartment of the eye. Although current therapies attempt to lower IOP by decreasing fluid production or increasing fluid drainage, many patients respond poorly to specific drugs, build tolerance, or do not experience sufficient lowering of IOP to slow disease progression. More than half of patients eventually require two or more drugs to adequately control their IOP. This leaves a significant need and opportunity for new drugs and classes of therapies, especially ones that increase the magnitude and duration of therapeutic effects.

Previous studies conducted with the University of Mississippi (UM) established that THCVHS decreased IOP significantly and over a longer duration than the top two commercially available treatments, latanoprost and timolol. Clinical evidence suggests that combining different classes of IOP-lowering drugs can provide additional benefit for some patients. This new study was designed, in collaboration with UM, to determine the benefit of combining THCVHS with other classes of IOP-lowering drugs, specifically a prostaglandin analogue (latanoprost) and a rho kinase inhibitor (netarsudil).

This study demonstrated that THCVHS combined with netarsudil achieved superior IOP-lowering and durability compared to latanoprost. Latanoprost’s average maximum IOP-lowering effect was 21.3% and it returned to baseline after 9 hours; THCVHS combined with netarsudil achieved an average maximum IOP-lowering effect of 32.4% and retained an average reduction in IPO of 26.5% at 9 hours. The data also showed superior IOP-lowering compared to netarsudil combined with latanoprost.

This study also reaffirmed THCVHS’ superior ability to significantly lower IOP over a longer duration compared to latanoprost: THCVHS achieved an average maximum reduction in IOP of 27.5% and maintained an average reduction in IOP of 21.1% after 9 hours, at which point latanoprost had returned to baseline.

“Our group has had significant experience formulating THCVHS for a variety of therapeutic indications and continues to discover new therapeutic applications for this promising molecule,” said Soumyajit Majumdar, PhD, Professor, Department of Pharmaceutics and Drug Delivery at University of Mississippi. “This study again highlights THCVHS’ superiority as a single agent over latanoprost to lower intraocular pressure, including its ability to maintain a significant therapeutic effect beyond nine hours. Importantly, the data also suggests the potential to further enhance the intraocular-pressure-lowering capabilities of THCVHS by combining it with specific alternative classes of IOP-lowering drugs. We anticipate sharing the complete set of data as part of a manuscript to be submitted to a peer-reviewed academic journal.”

“This new study provides positive new observations regarding THCVHS’ potential to provide advantageous therapeutic benefits for patients, both as a single agent and combined with other drugs, and we plan to fully investigate these possibilities,” said Punit Dhillon, Skye Bioscience, CEO. “These data suggest there is strong potential for THCVHS to be a once-a-day treatment, a desirable outcome for glaucoma treatments. With our recently announced progression on manufacturing and imminent toxicology studies, we continue our progress toward our first-in-human trial for THCVHS that is intended to start later this year.”

Study design

This study was conducted in collaboration with the University of Mississippi using three in vivo groups. Each group received a single 50 µL dose of THCVHS, latanoprost or netarsudil once daily for the first five days and then a combination of two different drugs once daily for the next five days. In the combined drug study, the second drug was administered 15 minutes after administering the first drug. IOP was measured over the course of 24 hours on days 1, 3 and 5 using single drug treatment and days 6, 8 and 10 using combination drug treatment. The study was performed with the following treatment regimens:

Single Drug Regimens

• Group 1: THCVHS 1.0%
• Group 2: latanoprost 0.005%
• Group 3: netarsudil 0.02%

Combined Drug Regimens

• Group 1: THCVHS 1.0% followed by netarsudil 0.02%
• Group 2: latanoprost 0.005% followed by THCVHS 1.0%
• Group 3: netarsudil 0.02% followed by latanoprost 0.005%

About THCVHS
THCVHS, a proprietary prodrug of tetrahydrocannabinol (THC), is a topical ocular formulation under development to treat glaucoma. Developed with rational drug design and biochemical engineering, THCVHS is a proprietary synthetic molecule that enables local delivery of the drug into the eye and reduces the potential for systemic side effects. In preclinical studies, THCVHS demonstrated superior lowering of intraocular pressure, a major risk factor related to irreversible vision loss, compared to the standard-of-care glaucoma treatment.

About the University of Mississippi
The University of Mississippi, the state’s flagship institution, is among the elite group of R-1: Doctoral Universities – Highest Research Activity in the Carnegie Classification. The university has a long history of producing leaders in public service, academics, research, and business. Its 15 academic divisions include a major medical school, nationally recognized schools of accountancy, law and pharmacy, and an Honors College acclaimed for a blend of academic rigor, experiential learning, and opportunities for community action.

UM’s research interests include studies of the botanical, pharmacological and chemical properties of the cannabis plant. Since 1968, the marijuana research lab at University of Mississippi’s School of Pharmacy has been the only facility in the United States permitted by the federal government’s National Institute on Drug Abuse to cultivate cannabis for research purposes.

About Skye Bioscience
Skye Bioscience Inc. is a biopharmaceutical company unlocking the pharmaceutical potential of cannabinoids through the development of its proprietary, cannabinoid-derived molecules to treat diseases with significant unmet needs. The company’s lead program, THCVHS, is focused on treating glaucoma, a disease with no cure and the world’s leading cause of irreversible blindness. For more information, please visit: www.skyebioscience.com.

CONTACT
Karam Takhar
VP, Corporate Development & Investor Relations
Email: [email protected]
Phone: (858) 410-0266

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements, including statements regarding our product development, business strategy, timing of clinical trials and commercialization of cannabinoid-derived therapeutics. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management’s current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including “anticipated,” “plans,” “goal,” “focus,” “aims,” “intends,” “believes,” “can,” “could,” “challenge,” “predictable,” “will,” “would,” “may” or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Risk Factors section of Skye’s most recent annual or quarterly report filed with the Securities and Exchange Commission. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.