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Vicapsys Life Sciences Completes Reverse Merger with Stateline Distributors of Puerto Rico and Signs Definitive Agreement to Acquire NitroMist(R), Creating a Vertically Integrated Pharmaceutical Manufacturing and Distribution Platform Serving Federal, Tribal and Underserved Markets

2026-09-22 12:05 ET - News Release

MIAMI, FL AND SAN JUAN, PUERTO RICO / ACCESS Newswire / September 22, 2026 / Vicapsys Life Sciences, Inc. (OTC PINK:VICP) ("VICP" or the "Company") today announced that it has completed its reverse merger with Stateline Distributors of Puerto Rico, Inc. ("Stateline"), effective September 3, 2026, and has entered into a definitive asset purchase agreement to acquire the FDA-approved NitroMist® (nitroglycerin) lingual aerosol product. Stateline is now a wholly owned subsidiary of VICP. The combined company is organized as a pharmaceutical platform that pairs licensed wholesale distribution and federal contracting access with owned branded products and, following the planned facility acquisition described below, in-house manufacturing.

Under the terms of the merger agreement, executed on August 12, 2026, Stateline's shareholders received shares of newly designated Series C Convertible Preferred Stock of VICP. Additional information regarding the merger and the NitroMist asset purchase agreement will be made available through the OTC Markets Disclosure & News Service at www.otcmarkets.com.

Stateline: Licensed Distribution Base with 50-State Reach

Stateline (Instagram@STLNIPO) is a specialty pharmaceutical wholesale distributor headquartered in San Juan, Puerto Rico, operating in compliance with the FDA-administered Drug Supply Chain Security Act (DSCSA). Stateline holds Puerto Rico wholesale drug distributor and biologics licenses and serves approximately 400 active healthcare accounts across the island.

Beyond Puerto Rico, Stateline operates a 50-state title model: Stateline takes title to product and fulfills through Drugzone, a 50-state-licensed, NABP-accredited third-party logistics provider. This structure gives Stateline nationwide distribution reach without the capital and time required to build licensed warehouses in each state, and allows the Company to place product with customers anywhere in the United States under a single DSCSA-compliant chain of custody.

Tribal 8(a) Teaming Agreement: Access to Set-Aside and Sole-Source Federal Channels

Stateline has a strategic teaming agreement with a tribally owned, SBA-certified 8(a) partner. Tribally owned 8(a) firms are eligible for sole-source federal contract awards above the competitive thresholds that apply to other 8(a) participants, and for set-aside procurements, including Buy Indian Act set-asides used by the Indian Health Service (IHS).

The teaming agreement vertically integrates Stateline's licensed distribution channel and procurement bandwidth with the partner's federal contracting eligibility. Through the partner, the combined company can pursue set-aside solicitations and sole-source awards, and can monetize IHS pharmaceutical supply contracts from a wholesale drug distribution perspective, supplying IHS federal facilities and tribally operated health programs with the products those contracts require.

Rural, tribal, IHS, Veterans Affairs, Department of Defense and Puerto Rico markets are structurally underserved by the three national wholesalers. The Company's strategy is to be the specialized distributor for these channels and, with in-house manufacturing, the specialized manufacturer as well.

NitroMist® Acquisition and Relaunch

VICP has entered into a definitive asset purchase agreement with KCK Sunshine, LLC to acquire NitroMist® (nitroglycerin) lingual aerosol, NDA 021780, a sublingual nitroglycerin spray indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. The assets to be acquired include the NDA, the NitroMist® trademark, global licensing, marketing and commercialization rights, and the product's formulation, manufacturing and stability know-how. NitroMist was previously marketed in the United States, was voluntarily discontinued by a prior owner effective December 31, 2022, for reasons unrelated to safety or effectiveness, and is not currently available to patients. The NDA remains approved and in effect.

Consideration for the acquisition is a US$2.0million convertible promissory note to be issued by VICP at closing. The note bears simple interest at 15% per annum, matures five years from issuance, and is convertible at the holder's option into VICP common stock at US$1.00 per share during the 36 months following issuance, with accrued interest converting together with principal. VICP may require conversion if the volume-weighted average price of its common stock equals or exceeds US$2.50 per share for 20 consecutive trading days during that period.

Closing is subject to customary conditions, including delivery of chain-of-title documentation for the NDA, FDA's acknowledgment of the transfer of the NDA to the seller, which has been submitted to FDA and is pending, and the NDA being current on annual reports and FDA user fees. At closing, the seller and VICP will submit the transfer-of-ownership and acceptance letters to FDA under FDA's change-of-ownership procedures (21 C.F.R. § 314.72) to transfer the NDA to VICP.

In preparation for the relaunch, VICP is working with its key contract manufacturing (CMO) partner to produce stability batches, medium-fill batches and pre-production batches of NitroMist. Returning the product to market will also require re-establishment of the manufacturing and supply chain, registration and process-validation batches, current stability data, an FDA supplement reflecting manufacturing changes since approval, and re-listing of the product's National Drug Code.

NitroMist is intended to be the Company's first owned branded product and to be distributed through Stateline's commercial channels and through the federal and tribal channels described above.

Manufacturing: Discussions to Acquire ~120,000 sq ft Puerto Rico Facility

VICP is currently in discussions to acquire an approximately 120,000-square-foot pharmaceutical manufacturing facility in Puerto Rico, formerly operated as an active pharmaceutical ingredient (API) manufacturing site by a major pharmaceutical company. The facility includes approximately 50,000 square feet of cleanroom manufacturing space and approximately 70,000 square feet of warehouse and distribution space.

Following restoration and requalification of the cleanrooms and FDA inspection, the facility is expected to give VICP the ability to manufacture NitroMist in-house, removing the Company's dependence on third-party manufacturing for its lead product. Beyond NitroMist, the cleanroom capacity provides a scalable manufacturing base intended to position the Company as a primary manufacturing-and-distribution source when IHS, the U.S. Department of Health and Human Services (HHS) and other federal agencies issue requests for proposals for specific drug products.

The combination of licensed distribution in Puerto Rico and across all 50 states, federal set-aside contracting access, an owned NDA and domestic manufacturing capacity is designed to allow VICP to respond to federal solicitations as a single integrated supplier: manufacturing the product, holding title to it and delivering it to the point of care.

Management Commentary

"Completing the Stateline merger gives VICP a licensed, revenue-generating operating base and a set of channels the national wholesalers have never prioritized," said Armando Rubio, Chairman and Chief Executive Officer of VICP. "With Stateline's 50-state title model, our tribal 8(a) teaming agreement, the definitive agreement to acquire NitroMist as our first owned product, and the Puerto Rico facility we are working to acquire, we are building a company that can manufacture, hold title to and deliver drugs for federal, tribal and underserved markets under one roof. Our immediate priorities are closing the NitroMist acquisition and getting the product back on the market, and closing on the facility. In parallel, Stateline will continue to pursue distribution opportunities in underserved markets, with full DSCSA compliance as the foundation of every product we ship."

Leadership

In connection with the closing, Armando Rubio serves as Chairman and Chief Executive Officer of VICP; Jean Dominguez as President; Alberto Dominguez as Chief Financial Officer; David Wayne Dunn as Executive Vice President of Sales; and Humberto Borque as Director of Economic Development for NitroMist. At Stateline, Prakash Pathare serves as Executive Sales Director and Angel L. Melendez as Pharmacist-in-Charge and licensed pharmacist of record. Federico Pier, VICP's former Chief Executive Officer, resigned from his positions with the Company in connection with the closing.

VICAPSYN™: Legacy Biotechnology Program Retained

In connection with the merger, VICP retains its legacy biotechnology program, VICAPSYN™, together with the Company's exclusive license from Massachusetts General Hospital for the underlying CXCL12 technology, as a continuing asset of the Company. The program targets the foreign body response, a biological mechanism responsible for implant rejection and fibrosis.

Retaining the program preserves shareholder optionality in the biotechnology asset and reflects the Company's commitment to maximizing value across both its pharmaceutical distribution platform and its legacy life sciences portfolio. The Company will describe any material developments in the program, including any change in the entity through which it is held, in its public disclosures.

Advisory Board

The Company is also onboarding the following members to its board of advisors:

  • Moe Vela, two-time White House senior advisor
  • Dr. Makarand(Mak) Jadawakar, former Pfizer scientist with nearly three decades at the company
  • Dr. Ismael Torres, former head of oncology for Puerto Rico
  • Mariano Dall'Orso, former Global Senior Vice President at Western Union
  • Luis Rey and Gustavo Koniszczer, Managing Partners of FutureBrand Latin America
  • Robert Ojeida, senior executive at K&B Associates, a group purchasing organization, and pharmaceutical industry executive

About Vicapsys Life Sciences, Inc.

Vicapsys Life Sciences, Inc. (OTC: VICP) is a publicly traded pharmaceutical platform company headquartered in Miami, Florida, with operations in San Juan, Puerto Rico. Through its wholly owned subsidiary, Stateline Distributors of Puerto Rico, Inc., VICP operates a DSCSA-compliant specialty pharmaceutical wholesale distribution business with a 50-state title model, and holds a strategic teaming agreement with a tribally owned 8(a) partner for federal set-aside and sole-source contracting. VICP's strategy is to build an integrated manufacturing and distribution platform serving rural, tribal, Indian Health Service, Veterans Affairs, Department of Defense and Puerto Rico markets, anchored by owned branded products, beginning with NitroMist®, which the Company has agreed to acquire. VICP also retains its legacy biotechnology program, VICAPSYN™, under the Company's exclusive license from Massachusetts General Hospital.

About Stateline Distributors of PuertoRico, Inc.

Stateline Distributors of Puerto Rico, Inc. is a specialty pharmaceutical wholesale distributor based in San Juan, Puerto Rico. Stateline holds Puerto Rico wholesale drug distributor and biologics licenses, operates in compliance with the DSCSA, serves approximately 400 active healthcare accounts, and extends its reach to all 50 states through a title model executed with third-party logistics partner Drugzone.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include, without limitation, statements regarding the Company's strategy and expected benefits of the merger; the closing of the NitroMist acquisition and the satisfaction of its closing conditions, including FDA's acknowledgment of the transfers of the NDA; the timing and success of the NitroMist relaunch; the proposed acquisition of the Puerto Rico manufacturing facility and the timing, cost and outcome of its restoration, requalification and FDA inspection; the Company's ability to obtain federal, tribal or Indian Health Service contracts through its teaming agreement; expected manufacturing and distribution capacity; the value of, and any future development of or strategic transaction involving, the VICAPSYN program and the Company's license from Massachusetts General Hospital; and the Company's ability to raise the capital required to execute its plans. Words such as "expects," "intends," "plans," "positions," "designed to," "preserves," "will," "may" and similar expressions identify forward-looking statements. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including: the NitroMist acquisition may not close on the terms described or at all; the facility acquisition may not be completed on the terms described or at all; FDA may not acknowledge the NDA transfers or approve required supplements on the anticipated timeline; manufacturing, stability and regulatory activities for NitroMist may be delayed or unsuccessful; federal and tribal contract awards are not assured; the VICAPSYN program may not advance or realize value, and the Company's license may be subject to termination or other adverse action; the Company may be unable to obtain financing on acceptable terms; and other risks and uncertainties affecting the Company's business. Forward-looking statements speak only as of the date of this release, and the Company undertakes no obligation to update them except as required by law.

Contact
Vicapsys Life Sciences, Inc.
Armando Rubio
Chairman and Chief Executive Officer
VICPINFO@protonmail.com
(305) 565-8002

SOURCE: Stateline Distributors



View the original press release on ACCESS Newswire

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