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

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

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the sections titled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in this Form 10-Q, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We are a clinical-stage company developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced clinically for two cardiac clinical indications based on the mechanism of action of treating microvascular dysfunction demonstrated by these cells in preclinical studies of enhanced microvascular density and reduced fibrosis: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced clinically as an "off the shelf" cell therapy based on the immunomodulatory mechanism of action for the treatment of ischemic inflammatory HFrEF. Our program for these same cells in acute respiratory distress syndrome has had its investigational new drug (IND) approved by the Food and Drug Administration (FDA), but we have not yet advanced this program in the clinic.

Our therapeutic candidates intended for cardiac indications are enabled by our Helix™ transendocardial biotherapeutic delivery system, which enables minimally invasive catheter-based intramyocardial therapeutic delivery. We partner this therapeutic delivery platform and provide development services selectively for others developing biotherapeutic interventions for local delivery to the heart.

To date, we have devoted substantially all of our resources to research and development efforts relating to our therapeutic candidates and biotherapeutic delivery systems, including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and protecting our intellectual property. We have also generated modest revenues from sales of our approved products. We have funded our operations primarily through the sales of equity and convertible debt securities, and certain government and private grants.

CardiAMP Autologous Cell Therapy for Ischemic Heart Failure (BCDA-01)

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient's own marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body's natural healing response to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, are all targets of CardiAMP cell therapy, largely through production of growth factors, cytokines, chemokines, and other factors that directly counteract each of these mechanisms. The CardiAMP autologous cell therapy is delivered during a standard minimally invasive catheter-based procedure. Patients are typically discharged after an overnight stay. The cell therapy is designed to promote microvascular repair through enhanced capillary density and reduced fibrosis, both of which have been demonstrated in small and large animal models of disease.

The CardiAMP cell therapy procedure for heart failure has a specific reimbursement code, C9782, which was established by the Centers for Medicare & Medicaid Services (CMS). This code is used by hospitals to bill for the procedure, including both the treatment and control arms of the CardiAMP Heart Failure Trial.

The CardiAMP Cell Therapy Heart Failure Trial (CardiAMP HF)

CardiAMP HF Trial was a randomized, double-blinded, placebo-procedure controlled study of 115 ischemic heart failure patients with HFrEF enrolled at 18 centers in the United States and Canada. The trial assessed the safety and effectiveness of the CardiAMP Cell Therapy System for the treatment HFrEF, an investigational device system that has received Breakthrough Device Designation from the FDA. All patients studied were maintained on heart failure medication, with treated patients receiving a single dose of CardiAMP Cell Therapy adjunctive to medication. Two-year results from the trial were presented as a late-breaking clinical trial at the American College of Cardiology Scientific Sessions on March 30, 2025. Results of the CardiAMP HF Trial showed reduction in all cause death, reduced major adverse cardiac events, and improved quality of life, with a composite endpoint that was statistically significant in patients having elevated NTproBNP, a marker of active heart stress.

We have submitted this two-year data to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and requested a meeting to receive advice on the potential to align with PMDA on the acceptability of the clinical data and positioning of the CardiAMP system for Japanese patients with heart failure. We anticipate an in-person consultation in the fourth quarter of 2025, the outcome of which could enable us to submit for approval of the CardiAMP system for market entry in Japan.

In the fourth quarter of 2025, we expect to complete submission of the CardiAMP HF data and request a meeting with the FDA to discuss the approvability of CardiAMP Cell Therapy for treatment of ischemic heart failure based on the available clinical data, even as the confirmatory CardiAMP HF II trial is enrolling. The FDA has previously approved a number of important high-risk cardiovascular therapeutic medical devices where safety and benefit were demonstrated but which did not meet pivotal study primary endpoints.

CardiAMP HF II Phase 3 Trial in Ischemic HFrEF

CardiAMP HF II is a 250-patient randomized multicenter procedure placebo-controlled study of the CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic heart failure with HFrEF on guideline directed medical therapy having elevated NTproBNP. The study is intended to confirm the safety and efficacy results in these patients observed in the CardiAMP HF study.

The primary endpoint in CardiAMP HF II is an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld hierarchical analysis. The tiers, starting with the most serious events, would be (1) all-cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal Major Adverse Coronary and Cerebrovascular Events (MACCE), excluding those deemed procedure-related occurring within the first seven days post-procedure (heart failure hospitalization, stroke or myocardial infarction), ordered by time to event, and (3) change from baseline in quality of life at a minimum of 12 months and a maximum of 24 months. In CardiAMP HF, this composite efficacy endpoint was achieved with statistical significance in the subset of patients with elevated NTproBNP that are the focus of the CardiAMP HF II study (p=0.02).

Advances in this therapeutic approach in CardiAMP HF II include using the cell population analysis at screening to define treatment doses, which enables more patients to be eligible for the therapy, and improvements to the Helix system, which include the introduction of the FDA approved Morph DNA steerable platform.

Patient randomization in the trial has commenced at the four actively enrolling centers in the United States. Additional centers are being onboarded. Medicare reimbursement for both treated and controlled patients under C9782 is currently $17,500, which helps offset the costs of this study.

CardiAMP Autologous Cell Therapy for Chronic Myocardial Ischemia (BCDA-02)

CardiAMP Cell Therapy system, under a second FDA approved investigational device exemption, is being studied in a second related clinical indication of chronic myocardial ischemia with refractory angina. This study is based on the strength of our Phase 2 and 3 ischemic heart failure trial data and the previous clinical data on CD34+ mononuclear cells in this indication.

The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is a Phase 3, multi-center, randomized, double-blinded, placebo-controlled study of up to 343 patients at up to 40 clinical sites. The trial is designed to provide the primary support for the safety and efficacy of the CardiAMP Cell Therapy System for patients with no option chronic myocardial ischemia with refractory angina. These patients experience frequent angina (i.e., chest pain) attacks that are uncontrolled by optimal drug therapy, and these patients are not suitable candidates for stent placement or bypass surgery, leaving them few therapeutic options.

Results from the open-label roll-in cohort of patients having chronic myocardial ischemia with refractory angina to date have shown an average 107 second increase in exercise tolerance and an 82% average reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment. The last roll-in cohort patient has recently reached this six-month primary endpoint, and we intend to prepare the primary results of this cohort for publication and presentation.

The CardiAMP cell therapy procedure for chronic myocardial ischemia is also reimbursed by CMS under reimbursement code C9782, which covers both treated and controlled patients.

CardiALLO Allogeneic MSC for Ischemic Heart Failure with HFrEF (BCDA-03)

The Investigational New Drug application (IND) for a Phase 1/2 trial to deliver our allogeneic MSC for the treatment of HFrEF includes a 3+3 roll-in dose escalation cohort now followed by a 360-patient randomized double-blind controlled study based on a recent IND amendment to right size the study for nondilutive funding opportunities. The study utilizes the Finkelstein Schoenfeld three tier primary composite endpoint of mortality, MACCE, and functional capacity as measured by six-minute walk distance. The low dose cohort of 20 million cells has been completed and there have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic response. The Data Safety Monitoring Board recommended that the study proceed as designed in April 2025 based on the 30-day data safety assessment from this cohort.

We intend to fund development through nondilutive grants and partnering. Phase 2 development is anticipated to be advanced in both the United States and Japan and would also enroll in approximately one year. It is expected that after the completion of this Phase 2 study that conditional approval in Japan may be pursued followed by a post-marketing study over a period of five years to further add to the evidence of safety and benefit.

Helix™Biotherapeutic Delivery System

The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart. Helix empowers a seamless transition from bench to commercialization for partners. Our biotherapeutic delivery partnerships are expected to enhance future treatment options for millions of people suffering from heart disease, offset the costs of biotherapeutic delivery for our own programs, and provide our investors with meaningful revenue sharing should our partnering efforts contribute to successful therapeutic development. We intend to submit for approval of the Helix Transendocardial Delivery System (Helix) to FDA as a DeNovo 510(k) application based on its safety and performance in twelve cell and gene therapy clinical studies. The clinical performance of the Helix system sets a high safety standard with more than 4,000 intramyocardial deliveries including studies under CE-mark in Europe. Therapeutic agent retention in the heart has also been shown to be superior using Helix compared to other catheter and surgical delivery approaches.

Morph®DNA Steerable Introducers

All procedures using our Helix transendocardial delivery system include the use of a Morph steerable introducer. We are actively transitioning all procedures using our Helix transendocardial delivery system to our new FDA cleared Morph DNA platform. We received FDA market clearance of an 8 French equivalent for transseptal cardiac procedures, under the name AVANCE. One of the device's features is that its tendons are designed to enable deflection rotation around the catheter shaft, providing uniform bending in all directions and a substantial reduction of what is called catheter "whip." This feature is designed to enhance physician control for many procedures. For procedures in the left ventricle of the heart, such as cell and gene therapy and ablation of ventricular tachyarrhythmia, we believe it presents significant advantages.

Fusion Imaging

We have developed global intellectual property around fusion imaging with a focus on cardiac biotherapeutic delivery and biopsy. During the quarter, we entered into a development, license, distribution and option agreement with CART-Tech, B.V., a Netherlands corporation. Under the agreement, the parties will develop and commercialize a fusion imaging system for these applications. The parties anticipate issuing a joint press release on this relationship.

Financial Overview

Revenue

The Company has no significant revenues at present. Our primary historical and near-term revenue potential is expected to be derived from our biotherapeutic delivery partnering agreements and sale of Morph products. Under these biotherapeutic delivery partnering agreements, we provide extensive support and our Helix biotherapeutic delivery system from the research bench to commercialization for partners. Our FDA-cleared AVANCE and Morph DNA steerable introducer products are available commercially and we are seeking partnerships to advance these primarily for mapping and treating atrial and ventricular tachyarrhythmias.

Research and Development Expenses

Our research and development expenses consist primarily of:

	•	salaries and related overhead expenses, which include share-based compensation and benefits for personnel in research and development functions;
	•	fees paid to consultants and contract research organizations, or CROs, including in connection with our preclinical studies and clinical trials and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial management and statistical compilation and analysis;
	•	costs related to acquiring and manufacturing clinical trial materials;
	•	costs related to compliance with regulatory requirements; and
	•	payments related to licensed products and technologies.

We expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress of completion of specific tasks using information and data provided to us by our vendors and clinical sites. Nonrefundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered and the services are received.

We plan to increase our research and development expenses as we continue the pivotal CardiAMP autologous cell therapy trials in heart failure and chronic myocardial ischemia, and our allogeneic cell therapy trial in heart failure and respiratory distress syndrome. We typically use our employee and infrastructure resources across multiple research and development programs, and accordingly, we have not historically allocated resources specifically to our individual programs. There are also significant synergies between these programs.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist primarily of salaries and related costs for employees in executive, finance and administration, sales, corporate development and administrative support functions, including share-based compensation expenses and benefits. Other selling, general and administrative expenses include sales commissions, rent, accounting and legal services, obtaining and maintaining patents, the cost of consultants, occupancy costs, insurance premiums and information systems costs.

Other Income (Expense)

Other income and expense consist primarily of interest income we earn on our cash and cash equivalents.

Critical Accounting Policies and Estimates

Our management's discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with U.S. GAAP. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various judgements that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not clear from other sources. Actual results may differ from these estimates under different assumptions or conditions.

We define our critical accounting policies as those that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations as well as the specific manner in which we apply those principles. Our critical accounting policies are described in Item 7 in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 26, 2025, which is incorporated by reference herein.

Results of Operations

Comparison of Three and Six Months Ended June 30, 2025 and 2024

The following table shows our results of operations for the three and six months ended June 30, 2025 and 2024 (in thousands):

		Three months ended June 30,								Six months ended June 30,
		2025				2024				2025				2024
Revenue:
Collaboration agreement revenue		$	-			$	3			$	-			$	58
Costs and expenses:
Research and development			1,368				800				2,898				2,041
Selling, general and administrative			683				852				1,879				1,941
Total costs and expenses			2,051				1,652				4,777				3,982
Operating loss			(2,051	)			(1,649	)			(4,777	)			(3,924	)
Other income (expense):
Total other income, net			2				3				16				11
Net loss		$	(2,049	)		$	(1,646	)		$	(4,761	)		$	(3,913	)

Revenue. Revenue was $0 in the three months ended June 30, 2025 as compared to $3,000 in the three months ended June 30, 2024, and was $0 in the six months ended June 30, 2025 as compared to $58,000 in the six months ended June 30, 2024. The amount and timing of collaboration revenues is largely dependent on our partners' development activities and may be inconsistent and create significant variation in our revenues.

Research and Development Expenses. Research and development expenses increased to approximately $1.4 million in the three months ended June 30, 2025 as compared to $800,000 in the three months ended June 30, 2024, and increased to approximately $2.9 million in the six months ended June 30, 2025 as compared to approximately $2.0 million in the six months ended June 30, 2024, primarily due to closeout activities in the CardiAMP Heart Failure Trial and the beginning of enrollment in the CardiAMP Heart Failure II Trial.

Selling, General and Administrative Expenses. Selling, general and administrative expenses decreased to $683,000 in the three months ended June 30, 2025 as compared to $852,000 in the three months ended June 30, 2024, primarily due to lower professional fees and share-based compensation expense. Selling, general and administrative expenses remained consistent at approximately $1.9 million in the six months ended June 30, 2025 as compared to approximately $1.9 million in the six months ended June 30, 2024.

Liquidity and Capital Resources

We have incurred net losses each year since our inception and as of June 30, 2025, we had an accumulated deficit of approximately $164.9 million. We anticipate that we will continue to incur net losses for the next several years.

We have funded our operations principally through the sales of equity and convertible debt securities. As of June 30, 2025, we had cash and cash equivalents of $980,000.

The following table shows a summary of our cash flows for the periods indicated (in thousands):

		Six months ended June 30,
		2025				2024
Net cash provided by (used in):
Operating activities		$	(3,267	)		$	(2,842	)
Investing activities			(1	)			(3	)
Financing activities			1,877				3,163
Net increase (decrease) in cash and cash equivalents		$	(1,391	)		$	318

Cash Flows from Operating Activities. Cash flow from operating activities for any period is subject to many variables including the timing of cash receipts, payments to suppliers, and vendor payment terms. Cash flow used in operating activities increased to approximately $3.3 million during the six months ended June 30, 2025 as compared to approximately $2.8 million during the six months ended June 30, 2024, primarily due to closeout activities in the CardiAMP Heart Failure Trial and the beginning of enrollment in the CardiAMP Heart Failure II Trial.

Cash Flows from Financing Activities. Net cash provided by financing activities of approximately $1.9 million and approximately $3.2 million during the six months ended June 30, 2025 and 2024, respectively, related primarily to proceeds from the sale of common stock and warrants.

February 2024 Financing - On February 9, 2024, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors (the February 2024 Offering), which closed on February 13, 2024. Pursuant to the agreement, we sold 134,199 shares of our common stock, and warrants to purchase 67,104 shares of our common stock at an exercise price equal to $6.60 per warrant share, subject to certain adjustments, as provided under the terms of the warrant, which are exercisable at any time before February 13, 2026. The gross proceeds of the February 2024 Offering were $875,000, with associated issuance costs of $43,000.

September 2024 Financing - On August 29, 2024, we entered into securities purchase agreements (the Purchase Agreements) with certain purchasers, pursuant to which we agreed to issue, and sell and the purchasers, in the aggregate to buy, in a public offering (the Registered Offering) (i) 1,377,990 shares of our common stock, $0.001 par value per share (the Common Stock), and accompanying warrants to purchase up to 1,377,990 shares of Common Stock (the Common Warrants), at an offering price of $3.00 per share of Common Stock and accompanying Common Warrant, and (ii) pre-funded warrants (the Pre-Funded Warrants and together with the Common Warrants the Warrants) to purchase up to 1,022,010 shares of Common Stock and accompanying Common Warrants to purchase up to 1,022,010 shares of Common Stock, at an offering price of $2.999 per Pre-Funded Warrant and accompanying Common Warrant. Certain of the Company's directors and executive officers purchased an aggregate of 211,000 shares of Common Stock and accompanying Common Warrants. The Registered Offering closed on September 3, 2024, with the Company issuing 2,400,000 shares of Common Stock, including the exercise of the Pre-Funded Warrants, and Common Warrants to purchase 2,400,000 shares of Common Stock. Each Common Warrant is exercisable at a price per share of $3.00 and expires on September 3, 2029. The gross proceeds of the Registered Offering were $7.2 million, with associated issuance costs of $926,00.

April 2025 Financing - On April 22, 2025, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors (the April 2025 Offering), which closed on April 23, 2025. Pursuant to the agreement, we sold 406,818 shares of our common stock, and warrants to purchase an aggregate of 406,818 shares of our common stock at an exercise price equal to $1.905 per share, which are exercisable at any time before the earlier of April 24, 2030 or the approval by the Japanese Pharmaceuticals and Medical Devices Agency of our application of our CardiAMP Cell Therapy System. The gross proceeds of the April 2025 Offering were $775,000, with associated issuance costs of $56,000.

June 2025 Financing - On June 30, 2025, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors, as well as certain members of our board of directors and executive officers (the June 2025 Offering), which closed on June 30, 2025. Pursuant to the agreement, we sold 274,696 shares of our common stock, and warrants to purchase an aggregate of 274,696 shares of our common stock at an exercise price equal to $1.95 per share, which are exercisable at any time before the earlier of June 30, 2030 or the approval by the Japanese Pharmaceuticals and Medical Devices Agency of our application of our CardiAMP Cell Therapy System. The gross proceeds of the June 2025 Offering were $570,000, with associated issuance costs of $9,000.

At-the-Market (ATM) Offerings - On December 6, 2023, we entered into an "At The Market" offering agreement (the Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). Under the Sales Agreement, we may offer and sell our common stock, from time to time during the term of the Sales Agreement through or to HCW as sales agent or principal. We have filed a prospectus supplement (the ATM Prospectus Supplement), as supplemented, relating to the offer and sale of the shares pursuant to the Sales Agreement. The offering and sale of the shares will be made pursuant to the Company's previously filed and effective Registration Statement on Form S-3 (File No. 333-275099), which was initially filed with the Securities and Exchange Commission (the "SEC") on October 19, 2023 and declared effective on December 5, 2023. As of the date of this report, under the ATM Prospectus Supplement, we may issue up to $2.9 million of our common stock. We have agreed to pay HCW a commission equal to 3% of the gross proceeds from the sales of shares and have agreed to provide HCW with customary indemnification and contribution rights.

Activity under the Sales Agreement was as follows (in thousands except share amounts):

		Three months ended								Six months ended
		June 30,								June 30,
		2025				2024				2025				2024
Common shares sold			140,104				335,112				221,378				412,239
Gross proceeds		$	350			$	1,847			$	562			$	2,438
Associated issuance costs		$	45			$	71			$	72			$	103

During the period from July 1, 2025 to August 8, 2025 we sold an aggregate of 296,422 shares of common stock under the ATM Offerings at an average share price of $2.59 for total gross proceeds of $$769,000.

Future Funding Requirements

To date, we have generated modest revenues. We do not know when, or if, we will generate any revenue from our development stage biotherapeutic programs. We do not expect to generate any revenue from sales of our autologous and allogeneic cell therapy candidates unless and until we obtain regulatory approval. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, our therapeutic candidates. In addition, subject to obtaining regulatory approval for any of our therapeutic candidates and companion diagnostic, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate that we will need additional funding in connection with our continuing operations.

Based upon our current operating plan, we believe that the cash and cash equivalents of $980,000 as of June 30, 2025, and subsequent sales of common stock under the ATM Offerings, are not sufficient to fund our planned expenditures and meet our obligations beyond October 2025. In order to continue development of our therapeutic candidates beyond such time, we plan to raise additional capital in the near term, potentially including non-dilutive collaboration and licensing arrangements, debt or equity financing, or a combination from these sources. We may be unsuccessful in raising funds from any or all such sources, and to the extent we raise any funds, they may be on highly dilutive terms. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our therapeutic candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our therapeutic candidates.

Our future capital requirements will depend on many factors, including:

•

the progress, costs, results and timing of our autologous CardiAMP Cell Therapy System and allogeneic MSC clinical trials and related development programs;

•

FDA acceptance of our autologous CardiAMP Cell Therapy System and allogeneic MSC therapies for heart failure and for other potential indications;

•

the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals;

•

the costs associated with securing, establishing and maintaining commercialization and manufacturing capabilities;

•

the number and characteristics of product candidates that we pursue, including our product candidates in preclinical development;

•

the ability of our product candidates to progress through clinical development successfully;

•

our need to expand our research and development activities;

•

the costs of acquiring, licensing, or investing in businesses, products, product candidates and technologies;

•

our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;

•

the general and administrative expenses related to being a public company;

•

our need and ability to hire additional management and scientific, medical and sales personnel;

•

the effect of competing technological and market developments; and

•

our need to implement additional internal systems and infrastructure, including financial and reporting systems.

Until such time that we can generate meaningful revenue from our recurring revenue biotherapeutic delivering partnering business model and/or sales of approved therapies and products, if ever, we expect to finance our operating activities through public or private equity or debt financings, government or other third-party funding, marketing and distribution arrangements, and other collaborations, strategic alliances and licensing arrangements or a combination of these approaches. To the extent that we are able to raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our existing common stockholders may be highly diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. Debt financing, if available, may involve agreements that include conversion discounts or covenants limiting or restricting our ability to take specific actions, such as incurring debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, marketing and distribution arrangements or other collaborations, or strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, products, or therapeutic candidates or to grant licenses on terms that may not be favorable to us.

We have prepared our condensed consolidated financial statements as of June 30, 2025 on the basis that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. Due to the factors described above, there is substantial doubt about our ability to continue as a going concern within one year after the date these financial statements are issued. Our ability to continue as a going concern will depend, in a large part, on our ability to raise additional capital. If adequate funds are not available, we may be required to further reduce operating expenses, delay or reduce the scope of our product development programs, obtain funds through arrangements with others that may require us to relinquish rights to certain of our technologies or products that we would otherwise seek to develop or commercialize ourselves, or cease operations. While we believe in the viability of our strategy to raise additional funds, there can be no assurances that we will be able to obtain additional capital on acceptable terms and in the amounts necessary to fully fund our operating needs.

The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. If we are unable to continue as a going concern, we may be forced to liquidate assets. In such a scenario, the values received for assets in liquidation or dissolution could be significantly lower than the values reflected in our condensed consolidated financial statements.

Off-Balance Sheet Arrangements

During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under the rules of the Securities and Exchange Commission.

Recent Accounting Pronouncements

See Note 2 of our notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for information regarding recent accounting pronouncements that are of significance or potential significance to us.