PetVivo Holdings Inc.

11/14/2025 | Press release | Distributed by Public on 11/14/2025 15:03

Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

GENERAL

PetVivo Holdings, Inc. (the "Company," "PetVivo," "we" or "us) is an emerging biomedical device company focused on the manufacturing, commercialization, and licensing of innovative medical devices and therapeutics for animals. The Company has a pipeline of products for the treatment of animals. A portfolio of nineteen patents protects the Company's biomaterials, products, production processes, and methods of use. The Company began commercialization of its lead product Spryng® with OsteoCushion® Technology, a veterinarian-administered, intraarticular injection for the management of lameness and other joint afflictions such as osteoarthritis in dogs and horses, in the second quarter of its fiscal year ended March 31, 2022.

The Company was incorporated in March 2009 under Nevada law under a different name. The Company operates as one segment from its corporate headquarters in Edina, Minnesota.

CURRENT BUSINESS OPERATIONS

The Company is primarily engaged in the business of commercializing and licensing products in the veterinary market to treat and/or manage afflictions of companion animals such as dogs and horses. Most of our technology was developed for human biomedical applications, and we intend to leverage the investments already expended in their development to commercialize treatments for horses and companion animals in a capital and time-efficient way.

The Company's initial product, Spryng®, and its pipeline products are derived from proprietary biomaterials that simulate a body's cellular tissue by virtue of their reliance upon natural protein and carbohydrate compositions which incorporate such "tissue building blocks" as collagen, elastin, and proteoglycans such as heparin. Since these are naturally-occurring in the body, we believe they have an enhanced biocompatibility with living tissues compared to synthetic biomaterials such as those based upon alpha-hydroxy polymers (e.g PLA, PLGA, and the like), polyacrylamides, and other "natural" biomaterials that may lack the multiple proteins incorporated into our biomaterials. These proprietary protein-based biomaterials are similar to the body's tissue thus allowing integration and tissue repair in long-term implantation in certain applications.

Our initial product, Spryng®, is a veterinary medical device designed to help reinforce and/or augment articular cartilage tissue for the management of lameness and other joint related afflictions, such as osteoarthritis, in horses and companion animals. Spryng® is an intra-articular injectable product of biocompatible and insoluble particles that are slippery, wet-permeable, durable, and resilient to enhance the force cushioning function of the synovial fluid and cartilage. The particles mimic natural cartilage in composition, structure, and hydration. Multiple joints can be treated simultaneously. Our particles are comprised of collagen, elastin, and heparin, similar components found in natural cartilage. These particles show an effectiveness in reinforcing and/or augment the cartilage, which enhances the functionality of the joint (e.g. provide cushion or shock-absorbing features to the joint and to provide joint lubricity).

Osteoarthritis, a common inflammatory joint disease in both dogs and horses, is a chronic, progressive, degenerative joint disease that is caused by a loss of synovial fluid and/or the deterioration of joint cartilage. Osteoarthritis affects approximately 14 million dogs and 1 million horses in the $11 billion companion animal veterinary care and product sales market.

Despite the market size, veterinary clinics and hospitals have very few treatments and/or drugs for use in treating osteoarthritis in dogs, horses, and other pets. As there is no cure for osteoarthritis, current solutions treat symptoms, but do not manage the cause. The current treatment for osteoarthritis in dogs generally consists of the use of nonsteroidal anti-inflammatory drugs (or "NSAIDs") which are approved to alleviate pain and inflammation but present the potential for side effects relating to gastrointestinal, kidney, and liver damage and do not halt or slow joint degeneration. The Company offers an alternative to traditional treatments that only address the symptoms of the affliction. Spryng® with OsteoCushion® technology addresses the affliction, loss of synovial fluid, and/or the deterioration of joint cartilage, rather than treating just the symptoms and, to the best of our knowledge, has elicited minimal adverse side effects in dogs and horses. Spryng®-treated dogs and horses have shown an increase in activity even after they no longer are receiving pain medication or other treatments. Other treatments for osteoarthritis include steroid and/or hyaluronic acid injections, which are used for treating pain, inflammation and/or joint lubrication, but can be slow acting and/or short lasting.

We believe Spryng® is an optimal solution to safely improve joint function in animals for several reasons:

Spryng® addresses the underlying problems which relate to deterioration of cartilage causing bones to contact each other and a lack of synovial fluid. Spryng® provides a biocompatible lubricious cushion to the joint, which establishes a barrier between the bones, thereby protecting the remaining cartilage and bone.
Spryng® is easily administered with the standard intra-articular injection technique. Multiple joints can be treated simultaneously.
Case studies indicate many dogs and horses have long-lasting multi-month improvement in lameness after having been treated with Spryng®.
After receiving a Spryng® injection, many canines are able to discontinue the use of NSAID's, eliminating the risk of negative side effects.
Spryng® is an effective and economical solution for treating osteoarthritis. A single injection of Spryng® is approximately $600 to $900 per joint and typically lasts for at least 12 months.

Historically, drug sales represent up to 30% of revenues at a typical veterinary practice (Veterinary Practice News). Revenues and margins at veterinary practices are being eroded because online, big-box, and traditional pharmacies have recently started filling veterinary prescriptions. Veterinary practices are looking for ways to replace lost prescription revenues with safe and effective products. Spryng® is a veterinarian-administered medical device that should expand practice revenues and margins. We believe that the increased revenues and margins provided by Spryng® will accelerate its adoption rate and propel it forward as the standard of care for canine and equine lameness related to or due to synovial joint issues.

We commenced sales of Spryng® in the second quarter of fiscal 2022 and plan to increase our commercialization efforts of Spryng® in the United States through our distribution relationship with MWI Veterinary Supply Co. ("Distributor" or "MWI"), Vedco, Inc. and the use of sales reps, clinical studies, and market awareness to educate and inform key opinion leaders on the benefits of Spryng®.

VetStem, Inc.

On February 14, 2025, the "Company" and VetStem, Inc. ("VetStem") entered into an Exclusive License and Supply Agreement pursuant to which VetStem will license to us, on an exclusive basis, the right to sell, have sold, offer for sale and import Therapeutic Compositions and Products involving PrecisePRP™ equine and PrecisePRP™ canine. Exclusivity shall be maintained as long as the mutually agreed upon annual minimum purchases of Products are made during the first five years of the Agreement, with an option to extend exclusivity upon the mutual agreement of the Parties.

VetStem, Inc. is a veterinarian-led company established in 2002 to bring regenerative medicine to the veterinary profession. Based near San Diego, California, this privately held biopharmaceutical enterprise offers veterinarians a range of regenerative modalities, including autologous stem cell processing from patients' own fat tissue. With over 15 years of expertise and thousands of treatments for joint, tendon, and ligament issues, VetStem has made regenerative medicine a therapeutic reality. The VetStem team is dedicated to developing clinically practical and affordable solutions that harness the natural restorative abilities of living organisms. In addition to its own patents, VetStem holds exclusive global veterinary licenses to a significant portfolio of patents in regenerative medicine and is in the late stages of approval of additional regenerative medicine solutions for the veterinarian.

PrecisePRP is a first-in-class off-the-shelf platelet-rich plasma (PRP) product designed for use by veterinarians. It is a leucoreduced, allogeneic, pooled, freeze-dried PRP intended to provide a species-specific source of concentrated platelets in plasma for intra-articular administration in dogs and horses. Unlike any PRP mechanical kits currently on the market. PrecisePRP™ does not require a blood draw or centrifugation making it a truly off-the-shelf product that is easy and convenient. Perhaps more important is the uniformity and consistency that PrecisePRP guarantees. Each vial of PrecisePRP contains a consistent dose of 4 billion platelets per vial at a concentration of 500,000 platelets per microliter and is leucoreduced with less than 1,500 white blood cells per microliter.

To significantly minimize safety risks, all dog and horse donors are screened according to the FDA CVM Guidance 254. Along with infectious disease screening, donors are tested for blood type and plasma antibody to red blood cells, providing a low risk of transfusion reaction. At the request of the FDA, two randomized placebo-controlled safety studieswere conducted in dogs and horses. There were no treatment-related adverse events reported in dogs or horses after treatment with PrecisePRP.

"This is a game changer for veterinarians and their ability to treat their patients with PRP", said Mike Eldred, PetVivo Board Member. "This innovative, and FDA reviewed product, will be a great addition to Spryng® with OsteoCushion® technology, and supports our strategy to be the leader in veterinary medical devices and regenerative medicine."

Distributors

We entered into a Distribution Services Agreement ("Distribution Agreement") with MWI on June 17, 2022. Pursuant to the Agreement, we appointed MWI to distribute, advertise, promote, market, supply, and sell the Company's lead product, Spryng® on an exclusive basis for two (2) years within the United States (the "Territory"), transitioning to a non-exclusive basis thereafter; provided however that the Company shall extend the exclusivity for an additional one (1) year if MWI achieves certain performance targets agreed upon by the parties. The Company can continue to sell Spryng® within the Territory to established accounts, which include: (a) customers who have purchased Spryng® from the Company prior to the date of the Agreement, (b) customers who require that they deal directly with the Company, (c) governmental agencies, and (d) customers that order via the internet who are not directly solicited by MWI to purchase Spryng®. All customers must be licensed veterinary practices.

Spryng® is classified as a veterinary medical device under the United States Food and Drug Administration ("FDA") rules, and pre-market approval is not required by the FDA. Spryng® completed a safety and efficacy study in rabbits in 2007. Since that time, more than 2,000 horses and dogs have been treated with Spryng®. We entered into a clinical trial services agreement with Colorado State University on November 5, 2020. We expect this university clinical study to be completed in March 2024. Additionally, the Company successfully completed an equine tolerance study in March 2022 and began two canine clinical studies with Ethos Veterinary Health, the first beginning in May of 2022 with anticipated completion in October 2023, and the second beginning in June of 2023 with an expected completion in October 2024. We anticipate that these and other studies that we plan to initiate will be primarily used to expand our distribution outlets since the large international and national distributors generally require a third-party university study and other third-party studies prior to including a product in their catalog of products.

We manufacture our products in an ISO 7 certified clean room manufacturing facility in Minneapolis using our patented and scalable self-assembly production process, which minimizes the infrastructure requirements and manufacturing risks to deliver a consistent, high-quality product while being responsive to volume requirements. A second ISO cleanroom facility is expected to be operational later this year. We believe that having two manufacturing facilities will help us minimize supply risks, allow for continued scaling of our production capacity, and expand our research and development facilities.

We also have a pipeline of therapeutic devices for both veterinary and human clinical applications. Some such devices may be regulated by the FDA or other equivalent regulatory agencies, including but not limited to the Center for Veterinary Medicine ("CVM"). We anticipate growing our product pipeline through the acquisition or in-licensing of additional proprietary products from human medical device companies specifically for use in pets. In addition to commercializing our own products in strategic market sectors and in view of the Company's vast proprietary product pipeline, the Company may establish strategic out-licensing partnerships to provide secondary revenues.

RESULTS OF OPERATIONS

The following discussion should be read in conjunction with our 2025 10-K Report and the condensed consolidated financial statements and related notes in Item 1, Financial Statements appearing elsewhere in this Quarterly Report on Form 10-Q ("10-Q Report"). The following discussion may contain forward-looking statements, and our actual results may differ materially from the results suggested by these forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in Part I, Item 1A of our 2025 10-K Report under the heading "Risk Factors," as updated and supplemented by risks described in other SEC filings. The Company assumes no obligation to revise or update any forward-looking statements for any reason, except as required by law.

We are a smaller reporting company and have incurred substantial losses in connection with our operations. We will need substantial capital to pursue our current plans to commercialize our initial product, Spryng®.

RESULTS OF OPERATIONS

For the Three Months Ended

September 30,

For the Six Months Ended

September 30,

2025 2024 2025 2024
Revenues $ 303,284 $ 200,720 $ 600,784 $ 324,470
Cost of Sales 83,226 21,162 194,000 34,156
Operating Expenses 2,285,425 2,352,598 4,316,468 4,507,787
Other (Expense) Income (942,442 ) (2,453 ) (1,409,162 ) (5,083 )
Net Loss $ (3,007,809 ) $ (2,175,493 ) $ (5,318,846 ) $ (4,222,556 )
Net loss per share - basic and diluted $ (0.11 ) $ (0.11 ) $ (0.20 ) $ (0.22 )

For The Three Months Ended September 30, 2025, Compared to The Three Months Ended September 30, 2024

Total Revenues. Revenues were $303,284 and $200,720 for the three months ended September 30, 2025 and 2024, respectively. Revenues in the three months ended September 30, 2025, consist of sales of our Spryng® products of $186,902 and PrecisePRP™ products of $116,382. Revenues in the three months ended September 30, 2024, consisted of sales entirely of our Spryng® products of $200,720. The increase in our revenues in the three months ended September 30, 2025, compared to the three months ended September 30, 2024, is due to sales of PrecisePRP™ products, pursuant to our exclusive licensing agreement with VetStem.

Cost of Sales. Cost of sales were $83,226 and $21,162 for the three months ended September 30, 2025 and 2024, respectively. Cost of sales includes product costs and labor and overhead related to the sale of our Spryng® products and product costs related to the sale of PrecisePRP™ products. The increase in our cost of sales in the three months ended September 30, 2025, compared to the three months ended September 30, 2024, is due to sales of PrecisePRP™ products.

Operating Expenses. Operating expenses were $2,285,425 and $2,352,598 for the three months ended September 30, 2025 and 2024, respectively. The decrease is primarily due to decreased general and administrative ("G&A") expenses and research and development ("R&D") expenses.

General and administrative ("G&A") expenses were $1,236,730 and $1,267,117 for the three months ended September 30, 2025 and 2024, respectively. General and administrative expenses include compensation and benefits, contracted services, legal and consulting fees, and stock compensation expenses.

Sales and marketing expenses were $787,262 and $620,307 for the three months ended September 30, 2025 and 2024, respectively. Sales and marketing expenses include compensation, consulting, tradeshows, and stock compensation costs to support the launch of our Spryng® and the PrecisePRP™ products.

Research and development ("R&D") expenses were $261,433 and $465,174 for the three months ended September 30, 2025 and 2024, respectively. The decrease was primarily related to decreased clinical studies due to tight cash flow constraints.

Operating Loss. As a result of the foregoing, our operating loss was $2,065,367 and $2,173,040 for the three months ended September 30, 2025 and 2024, respectively. The decrease was related to cost-cutting initiatives in general and administrative and research and development expenses.

Other Income (Expense). Other income (expense) was ($942,442) for the three months ended September 30, 2025 compared to other expense of ($2,453) for the three months ended September 30, 2024. Other income (expense) in 2025 consisted of unrealized loss on change in derivative liabilities, amortization of debt discount and interest expense. Other income (expense) in 2024 consisted of interest expense.

Net Loss. Our net loss for the three months ended September 30, 2025 was $3,007,809 or ($0.11) per share as compared to a net loss of $2,175,493 or ($0.11) per share for the three months ended September 30, 2024. The increase was primarily related to the loss on change in derivative liabilities and amortization of debt discount. The weighted average number of shares outstanding was 27,579,136 compared to 20,099,095 for the three months ended September 30, 2025 and 2024, respectively.

For The Six Months Ended September 30, 2025, Compared to The Six Months Ended September 30, 2024

Total Revenues. Revenues were $600,784 and $324,470 for the six months ended September 30, 2025 and 2024, respectively. Revenues for the six months ended September 30, 2025, consist of sales of our Spryng® products of $335,145 and PrecisePRP™ products of $265,639. Revenues in the six months ended September 30, 2024, consisted of sales entirely of our Spryng® products of $324,470. The increase in our revenues in the six months ended September 30, 2025, compared to the six months ended September 30, 2024, is due to sales of PrecisePRP™ products, pursuant to our exclusive licensing agreement with VetStem.

Cost of Sales. Cost of sales were $194,000 and $34,156 for the six months ended September 30, 2025 and 2024, respectively. Cost of sales includes product costs and labor and overhead related to the sale of our Spryng® products and product costs related to the sale of PrecisePRP™ products. The increase in our cost of sales for the six months ended September 30, 2025, compared to the six months ended September 30, 2024, is due to sales of PrecisePRP™ products.

Operating Expenses. Operating expenses were $4,316,468 and $4,507,787 for the six months ended September 30, 2025 and 2024, respectively. The decrease is primarily due to decreased general and administrative ("G&A") expenses and sales and marketing expenses related to the sale of our Spryng® products.

General and administrative ("G&A") expenses were $2,305,548 and $2,500,378 for the six months ended September 30, 2025 and 2024, respectively. General and administrative expenses include compensation and benefits, contracted services, legal and consulting fees, and stock compensation expenses.

Sales and marketing expenses were $1,408,974 and $1,154,720 for the six months ended September 30, 2025 and 2024, respectively. Sales and marketing expenses include compensation, consulting, tradeshows, and stock compensation costs to support the sales of our Spryng® and PrecisePRP™ products.

Research and development ("R&D") expenses were $601,946 and $852,689 for the six months ended September 30, 2025 and 2024, respectively. The decrease was primarily related to decreased clinical studies due to tight cash flow constraints.

Operating Loss. As a result of the foregoing, our operating loss was $3,909,684 and $4,217,473 for the six months ended September 30, 2025 and 2024, respectively. The decrease was related to cost-cutting initiatives in general and administrative and research and development ("R&D") expenses.

Other Income (Expense). Other expense was ($1,409,162) and $5,083 for the six months ended September 30, 2025 and 2024, respectively. Other income (expense) in 2025 consisted of unrealized loss on change in derivative liabilities, loss on disposal of assets, amortization of debt discount and interest expense. Other income (expense) in 2024 consisted of interest expense.

Net Loss. Our net loss for the six months ended September 30, 2025 was $5,318,846 or ($0.20) per share as compared to a net loss of $4,222,556 or ($0.22) per share for the six months ended September 30, 2024. The increase was related to the unrealized loss on change in derivative liabilities, loss on disposal of assets, amortization of debt discount and interest expense. The weighted average number of shares outstanding was 25,949,915 compared to 19,395,401 for the six months ended September 30, 2025 and 2024, respectively.

LIQUIDITY AND CAPITAL RESOURCES

As of September 30, 2025, our current assets were $2,109,723, including $767,914 in cash and cash equivalents. In comparison, our current liabilities as of that date were $1,052,694 including $988,979 of accounts payable and accrued expenses. Our working capital as of September 30, 2025 was $1,057,029.

The Company has continued to realize losses from operations. As a result of our private placement offering with proceeds of $5,000,000 from the sale of Series B convertible preferred stock, we do not believe we will have sufficient cash to meet our anticipated operating costs and capital expenditure requirements for at least the next twelve months. We will need to raise additional capital in the future to support our efforts to commercialize Spryng® and our ongoing operations. We expect to continue to raise additional capital through the sale of our securities from time to time for the foreseeable future to fund our business expansion. Our ability to obtain such additional capital will likely be subject to various factors, including our overall business performance and market conditions. There can be no guarantee that the Company will be successful in its ability to raise additional capital to fund its business plan.

Net Cash Used in Operating Activities - We used $3,828,209 of net cash in operating activities for the six months ended September 30, 2025. This cash used in operating activities was primarily attributable to our net loss of $5,318,846 and a decrease of accounts payable and accrued expenses of $786,183, along with the increased PrecisePRP™ production and inventory ramp-up.

Net Cash Used in Investing Activities - During the six months ended September 30, 2025, net cash used in investing activities was $6,605. This cash used in investing activities was primarily attributable to the purchase of equipment.

Net Cash Provided by Financing Activities - During the six months ended September 30, 2025, net cash provided by financing activities of $4,361,829 consisted of proceeds of Series B preferred stock receivable of $4,400,000, proceeds from the issuance of convertible debentures of $160,000 and proceeds from the exercise of a warrant of $140,000.

OFF-BALANCE SHEET ARRANGEMENTS

As of September 30, 2025, and as of the date of this Quarterly Report, we do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

GOING CONCERN

The report of independent registered public accounting firm accompanying our September 30, 2025 financial statements contain an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. The financial statements have been prepared assuming that we will continue as a going concern, which contemplates that we will realize our assets and satisfy our liabilities and commitments in the ordinary course of business. Our working capital at September 30, 2025, was $1,057,029. As a result of our private placement offering with proceeds of $5,000,000 from the sale of Series B convertible preferred stock, we believe the proceeds from this private placement offering are sufficient to fund operations until December 31, 2025 (see Liquidity and Capital Resources above).

We have continued to realize losses from operations. We will need to raise additional capital in the future to support our efforts to commercialize Spryng® and PrecisePRP™ products and our ongoing operations. We expect to continue to raise additional capital through the sale of our securities from time to time for the foreseeable future to fund our business expansion. Our ability to obtain such additional capital will likely be subject to various factors, including our overall business performance and market conditions. There can be no guarantee that the Company will be successful in its ability to raise additional capital to fund its business plan.

CRITICAL ACCOUNTING POLICIES

We prepare our consolidated financial statements in accordance with generally accepted accounting standards in the United States of America. Our significant accounting policies are described in Note 1 to our condensed consolidated financial statements attached hereto. We believe the following critical accounting policies involve the most significant judgments and estimates used in the preparation of the condensed consolidated financial statements.

RECENTLY ISSUED ACCOUNTING STANDARDS

The Company has reviewed the FASB issued ASU accounting pronouncements and interpretations thereof that have effective dates during the periods reported and in future periods. The Company has carefully considered the new pronouncements that alter previous generally accepted accounting principles and do not believe that any new or modified principles will have a material impact on the Company's reported financial position or operations in the near term. The applicability of any standard is subject to formal review of the Company's financial management.

In June 2016, the FASB issued ASU 2016-13, "Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments," which replaces the existing "incurred loss" model for recognizing credit losses with an "expected loss" model referred to as the CECL model. Under the CECL model, the Company is required to present certain financial assets carried at amortized cost, such as accounts receivable, at the net amount expected to be collected. The measurement of expected credit losses is based on information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. The Company adopted this standard in the consolidated financial statements for the year ended March 31, 2025. The change had no impact on the Company's financial statements.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose significant segment expenses and other segment items on an interim and annual basis and provide in interim periods all disclosures about a reportable segment's profit or loss and assets that are currently required annually. The ASU does not change how a public entity identifies its operating segments, aggregates them, or applies the quantitative threshold to determine its reportable segments. The new disclosure requirements are also applicable to entities that account and report as a single operating segment entity. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024. The Company adopted the guidance for the annual reporting period ended March 31, 2025. There was no impact on the Company's reportable segments identified.

All other newly issued but not yet effective accounting pronouncements have been deemed either immaterial or not applicable.

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