PetVivo Holdings, Inc. SEC 10-K Report

PetVivo Holdings, Inc., a biomedical device company specializing in the manufacturing, commercialization, and licensing of medical devices and therapeutics for animals, has released its Form 10-K report. The report provides a comprehensive overview of the company's financial performance, business operations, strategic initiatives, and the challenges it faces in the competitive veterinary market.

Financial Highlights

PetVivo Holdings, Inc. reported significant financial metrics for the fiscal year:

• Total Revenues: $1.13 million, an increase from $0.97 million in fiscal 2024, driven by sales to distributors and veterinary clinics.
• Total Cost of Sales: $0.14 million, up from $0.10 million in fiscal 2024, reflecting higher product costs and overhead.
• Total Operating Expenses: $9.05 million, a decrease from $11.49 million in fiscal 2024, primarily due to reduced general and administrative expenses and sales and marketing expenses.
• Operating Loss: $8.06 million, an improvement from $10.62 million in fiscal 2024, attributed to decreased general and administrative expenses and sales and marketing expenses.
• Net Loss: $8.40 million, an improvement from $10.96 million in fiscal 2024, with a net loss per share of $0.41 compared to $0.78 in fiscal 2024.

Business Highlights

PetVivo Holdings, Inc. has made notable strides in its business operations:

• Business Overview: The company focuses on manufacturing, commercializing, and licensing medical devices and therapeutics for animals, with a pipeline of 18 products and a portfolio of 12 patents and 6 proprietary trade secrets.
• Product Focus: The lead product, Spryng® with OsteoCushion® Technology, is an intra-articular injection for managing lameness and joint afflictions in dogs and horses, commercialized since the second quarter of fiscal year 2022.
• Distribution Agreements: PetVivo entered into a non-exclusive distribution agreement with Covetrus North America, LLC in December 2023, and later with Vedco Inc. and Clipper Distributing, LLC in December 2024, to expand its distribution network in the U.S.
• Regulatory Status: Spryng® is classified as a veterinary medical device under FDA rules, not requiring pre-market approval, and has been used in over 2,000 horses and dogs since its safety and efficacy study in 2007.
• Manufacturing Facilities: The company operates an ISO 7 certified clean room manufacturing facility in Minneapolis and plans to open a second facility to minimize supply risks and expand production capacity.
• Research and Development: PetVivo is pursuing advancements in its proprietary biomaterials and plans additional studies for Spryng® to treat osteoarthritis in canines and equines, alongside efforts to improve manufacturing systems.
• Intellectual Property: The company holds a robust intellectual property portfolio with six U.S. patents and additional patents in Canada and the EU, protecting its biomaterials, manufacturing processes, and applications.
• Market Position: The companion animal market is growing, with osteoarthritis affecting approximately 14 million dogs and 1.1 million horses in the U.S., presenting a significant opportunity for Spryng® as an alternative treatment.
• Future Outlook: PetVivo plans to continue expanding its product pipeline through acquisitions or in-licensing and aims to establish strategic out-licensing partnerships to generate secondary revenues.

Strategic Initiatives

PetVivo Holdings, Inc. has undertaken several strategic initiatives to bolster its market position and financial health:

• Strategic Initiatives: The company is focused on bringing its first product, Spryng®, to market, supported by distribution partnerships with Vedco and Clipper Distributing, as well as an Exclusive License Agreement with VetStem for the PrecisePRP product.
• Capital Management: The company entered into a Subscription Agreement for $5,000,000 in a Series B Preferred Offering, receiving $600,000 by March 31, 2025, with the remaining $4,400,000 received in May and June 2025. The company also raised capital through the sale of common stock and warrants, and issued convertible debentures. Additionally, the company has been actively issuing shares for services and converting debt into equity to manage its capital structure.
• Future Outlook: The company anticipates needing additional capital to support the commercialization of Spryng® and ongoing operations. It plans to continue raising capital through the sale of securities to fund business expansion. The ability to secure additional capital will depend on business performance and market conditions.

Challenges and Risks

PetVivo Holdings, Inc. faces several challenges and risks that could impact its business operations and financial performance:

• Commercialization Challenges: The company faces significant challenges in commercializing its lead product, Spryng®, due to its limited operating history and the need to establish effective production, marketing, sales, and distribution systems. The company is heavily reliant on Spryng® for future growth, and any failure to achieve market acceptance could significantly harm its business.
• Competitive Market: PetVivo operates in a highly competitive market with major pharmaceutical and biotechnology companies, which have substantially more resources.
• Financial Risks: The company has been delisted from The Nasdaq Capital Market and now trades on the OTCQB market, which may impact its ability to raise capital and attract investors. PetVivo has incurred substantial losses and may continue to do so until it can successfully commercialize Spryng®. The company has limited cash reserves and may need additional financing to continue operations.
• Operational Risks: There is a risk of not being able to manage rapid growth effectively if Spryng® experiences commercial success. The company relies on third parties for raw materials and clinical studies, which could pose risks if these parties fail to meet their commitments.
• Regulatory Risks: Regulatory risks include potential changes in classification of Spryng® by the FDA, which could require additional approvals.
• Going Concern: The independent auditor's report raises substantial doubt about the company's ability to continue as a going concern. PetVivo's financial condition is precarious, with a working capital deficit and a need for additional capital to support commercialization efforts.
• Market Risks: The company is exposed to market risks, including the volatility of its stock price due to limited public float and potential classification as a 'penny stock,' which could limit liquidity and investor interest. Additionally, the company faces risks related to its ability to raise capital in the future, which is critical for its ongoing operations and expansion plans.

SEC Filing: PetVivo Holdings, Inc. [ PETV ] - 10-K - Jul. 10, 2025