Rafael Holdings, Inc.

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We rely upon third parties for the manufacture of Trappsol® Cyclo™ and are dependent on their quality and effectiveness.

Previous report

Trappsol® Cyclo™ requires precise, high-quality manufacturing. The failure to achieve and maintain high manufacturing standards, including the failure to conform to c-GMP (current Good Manufacturing Practice), or to detect or control anticipated or unanticipated manufacturing errors or the frequent occurrence of such errors, could result in discontinuance or delay of ongoing or planned clinical trials, delays or failures in product testing or delivery, cost overruns, product recalls or withdrawals, patient injury or death, and other problems that could seriously hurt our business. Contract drug manufacturers often encounter difficulties involving production yields, quality control and quality assurance and shortages of qualified personnel. These manufacturers are subject to stringent regulatory requirements, including the FDA’s c-GMP regulations and similar foreign laws and standards. If our contract manufacturers fail to maintain ongoing compliance at any time, the production of our product candidates could be interrupted, resulting in delays or discontinuance of our clinical trials, additional costs and loss of potential revenues.

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We are dependent on the Cyclo management team, and our ability to advance the development, clinical texting, regulatory approval of our lead candidate, Trappsol® Cyclo™ may be materially and adversely affected if we lose them.

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The success of Cyclo to date has largely depended on the efforts and abilities of the Cyclo management team, namely N. Scott Fine, Jeffrey L. Tate, Ph.D. and Josh Fine. Our ability to advance our efforts of our Cyclo subsidiary could be materially and adversely affected if, for any reason, such individuals do not remain with us.

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A small number of our customers account for a substantial portion of our revenue, and the loss of any of these customers would materially decrease our revenues.

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Following consummation of the Cyclo Merger, sales of cyclodextrin products generates a significant portion of our revenues. In the third quarter of fiscal 2025, two major customers accounted for 77% of total revenues. Accounts receivable balances for these major customers represents 43% of total accounts receivable at April 30, 2025. We have a contract with only one of our major customers. The loss of one of these customers would materially decrease our revenues if we were unable to replace such customers.

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We are dependent on certain third-party suppliers.

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We purchase the Trappsol® cyclodextrin products we sell from third-party suppliers and depend on those suppliers for the cyclodextrins we use in our Aquaplex® products. We are also dependent on outside manufacturers that use lyophilization techniques for our Aquaplex® products. We purchase substantially all of our Trappsol® products from bulk manufacturers and distributors in the U.S., Japan, China, and Europe. Although products are available from multiple sources, an unexpected interruption of supply, or material increases in the price of products, for any reason, such as regulatory requirements, import restrictions, loss of certifications, power interruptions, fires, hurricanes, war or other events could have a material adverse effect on our business, results of operations, financial condition and cash flows.

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We may be negatively affected by currency exchange rate fluctuations.

Previous report

Our Product revenues and cash flows are influenced by currency fluctuations due to the geographic diversity of our suppliers, which may have a significant impact on our financial results. As we buy inventory from foreign suppliers, the change in the value of the U.S. dollar in relation to the Euro, Yen and Yuan has an effect on our cost of inventory, and will continue to do so. We buy most of our products from outside the U.S. using U.S. dollars. Our main supplier of specialty cyclodextrins and complexes, Cyclodextrin Research & Development Laboratory, is located in Hungary and its prices are set in Euros. The cost of our bulk inventory often changes due to fluctuations in the U.S. dollar. These products currently represent a significant portion of our revenues. When we experience short-term increases in currency fluctuation or supplier price increases, we are often not able to raise our prices sufficiently to maintain our historical margins and therefore, our margins on these sales may decline. If the U.S. dollar weakens against foreign currencies, the translation of these foreign currency denominated transactions may adversely affect our results of operations and financial condition.