Quarterly Report for Quarter Ending March 31, 2026 (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 plan of operations together with our condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from the plans, intentions, expectations and other forward-looking statements included in the discussion below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those factors discussed in the Risk Factors section of our 2025 Form 10-K on file with the SEC.

Overview

We are an artificial intelligence (A.I.) focused company dedicated to developing cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development. Our development portfolio includes three clinical stage oncology focused product candidates and consists of small molecules that others have tried, but failed, to develop into an approved commercialized drug, as well as new compounds that we are developing with the assistance of our proprietary A.I. platform and our biomarker driven approach. Our A.I. platform, known as RADR^®, currently includes more than 200 billion data points, and uses big data analytics (combining molecular data, drug efficacy data, data from historical studies, data from scientific literature, phenotypic data from trials and publications, and mechanistic pathway data) and machine learning to rapidly uncover biologically relevant genomic signatures correlated to drug response, and then identify the cancer patients that we believe may benefit most from our compounds. This data-driven, genomically-targeted and biomarker-driven approach allows us to pursue a transformational drug development strategy that identifies, rescues or develops, and advances potential small molecule drug candidates at what we believe is a fraction of the time and cost associated with traditional cancer drug development.

We have active clinical programs for our three lead small molecule drug candidates: LP-300, LP-184, and LP-284. These programs are focused on multiple important cancer indications, including both solid tumors and blood cancers. We have established a wholly-owned subsidiary, Starlight Therapeutics, to focus exclusively on the clinical development of our promising opportunities for central nervous system ("CNS") and brain cancers, many of which have no effective treatment options. We are also advancing an antibody-drug conjugate ("ADC") program focused on developing highly specific ADCs with highly potent drug-payloads.

In January 2026, we introduced withZeta.ai - a generative AI platform purpose-built to empower researchers and clinicians to accelerate rare cancer research and drug development, dramatically improve research quality, and reduce R&D costs. withZeta's multi-agentic architecture combines intelligent orchestration using a combination of proprietary knowledge bases and publicly available data with autonomous task completion to deliver a true "co-scientist" experience - one that brings the collective insight of thousands of domain experts, millions of publications, and billions of data points to address some of oncology's most difficult challenges and disease subtypes.

On May 13, 2026, we announced plans to create an independent business entity composed of the AI platform, withZeta.ai, and related technologies and personnel under the leadership of our CEO Mr. Panna Sharma. We intend to separate the withZeta.ai assets and technologies into an independent business entity in order to access dedicated funding sources and potentially realize valuation multiples separate from our primary drug development operations, which such entity we anticipate will become a newly listed company on a national stock exchange or market.

Our strategy is to both develop new drug candidates using our RADR^® platform, and other machine learning driven methodologies, and to pursue the development of drug candidates that have undergone previous clinical trial testing or that may have been halted in development or deprioritized because of insufficient clinical trial efficacy (i.e., a meaningful treatment benefit relevant for the disease or condition under study as measured against the comparator treatment used in the relevant clinical testing) or for strategic reasons by the owner or development team responsible for the compound. Importantly, these historical drug candidates appear to have been well-tolerated in many instances, and often have considerable data from previous toxicity, tolerability and ADME (absorption, distribution, metabolism, and excretion) studies that have been completed. Additionally, these drug candidates may also have a body of existing data supporting the potential mechanism(s) by which they achieve their intended biologic effect, but often require more targeted trials in a stratified group of patients to demonstrate statistically meaningful results. Our dual approach to both develop de-novo, biomarker-guided drug candidates and "rescue" historical drug-candidates by leveraging A.I., recent advances in genomics, computational biology and cloud computing is emblematic of a new era in drug development that is being driven by data-intensive approaches meant to de-risk development and accelerate the clinical trial process. In this context, we intend to create a diverse portfolio of oncology drug candidates for further development towards regulatory and marketing approval with the objective of establishing a leading A.I.-driven methodology for treating the right patient with the right oncology therapy.

A key component of our strategy is to target specific cancer patient populations and treatment indications identified by leveraging our RADR^® platform, a proprietary A.I. enabled engine created and owned by us. We believe the combination of our therapeutic area expertise, our A.I. expertise, and our ability to identify and develop promising drug candidates through our collaborative relationships with research institutions in selected areas of oncology gives us a significant competitive advantage. Our RADR^® platform has been developed and refined over the last several years and integrates billions of data points immediately relevant for oncology drug development and patient response prediction using artificial intelligence and proprietary machine learning algorithms. By identifying clinical candidates, together with relevant genomic and phenotypic data, we believe our approach will help us design more efficient pre-clinical studies, and more targeted clinical trials, thereby accelerating our drug candidates' time to approval and eventually to market. Although we have not yet applied for or received regulatory or marketing approval for any of our drug candidates, we believe our RADR^® platform has the ability to reduce the cost and time to bring drug candidates to specifically targeted patient groups. We believe we have developed a sustainable and scalable biopharma business model by combining a unique, oncology-focused big-data platform that leverages artificial intelligence along with active clinical and preclinical programs that are being advanced in targeted cancer therapeutic areas to address today's treatment needs.

Our current portfolio consists of three lead drug candidates that are in clinical phases (known as LP-300, LP-184 and LP-284) and an Antibody Drug Conjugate (ADC) program that is in preclinical research optimization. In January 2023, we formed a wholly owned subsidiary, Starlight Therapeutics Inc. ("Starlight"), to develop drug candidate LP-184's central nervous system (CNS) and brain cancer indications - including glioblastoma (GBM), brain metastases (brain mets.), and several rare pediatric CNS cancers. Following the formation of Starlight, we may also refer to the molecule LP-184, as it is developed in CNS indications, as "STAR-001". All of these drug candidates and our ADC program are leveraging precision oncology, A.I. and genomic driven approaches to accelerate and direct development efforts.

We are conducting a targeted phase 2 trial (the Harmonic™ trial) for LP-300 in never smoking patients with NSCLC in combination with chemotherapy, under an existing investigational new drug application. Based on the successful outcome in May 2026 from a Type C meeting request with the FDA focused on the LP-300 Harmonic™ clinical trial, we have determined to focus future Harmonic™ enrollment on patients with the EGFR exon 21 L858R mutation, a subtype of tyrosine kinase mutations that demonstrates lower sensitivity and inferior treatment outcome to osimertinib based therapy. Preliminary analysis of Harmonic™ study data suggests that patients with this mutation may derive greater clinical benefit from the LP-300 triplet regimen. Our candidate LP-184 has shown promising in-vitro and in vivo anticancer activity in multiple solid tumor indications (including triple negative breast, lung, bladder, glioblastoma and pancreatic cancer), and enrollment has been completed in a Phase 1a clinical trial for LP-184. Based on the results and insights from the LP-184 Phase 1a clinical trial, we are advancing and optimizing development plans for multiple future LP-184 clinical studies. Our candidate LP-284 has shown promising in-vitro and in vivo anticancer activity in multiple hematological cancers, which are distinct from the indications targeted by LP-184. LP-284 is currently in a Phase 1A clinical trial.

Our ADC program has also continued to advance. During 2024 and 2025, we continued to apply our RADR^® A.I. platform to advance and refine an A.I. powered module focused on improving the precision, cost and timelines of ADC development for cancer. In 2023, we entered into a research collaboration with Bielefeld University in Germany focused on development of ADCs utilizing cryptophycin as the ADC drug-payload. Cryptophycins are promising antitumor molecules that have demonstrated potency at ultra-low, picomolar, concentrations. In a broad range of preclinical studies, the cryptophycin-ADC synthesized as part of the Bielefeld collaboration demonstrated promising picomolar level potency and anti-tumor activity in multiple solid tumor cell lines, including breast, bladder, colorectal, gastric, pancreatic and ovarian.

In addition to our lead drug candidates and ADC program, we also have an additional drug candidate, LP-100, that we believe has potential for future development in combination with the class of anticancer agents known as PARP inhibitors (PARPi). For LP-100, as well as our lead drug candidate LP-300, we have leveraged data from prior preclinical studies and clinical trials, along with insights generated from our A.I. platform, to target the types of tumors and patient groups we believe will be most responsive to the drug. Both LP-100 and LP-300 showed promise in important patient subgroups, but failed pivotal Phase 3 trials when the overall results did not meet the predefined clinical endpoints. We believe that this was due to a lack of biomarker-driven patient stratification.

LP-300 has been studied in multiple randomized, controlled, multi-center non-small cell lung cancer, or NSCLC, trials that included administration of either paclitaxel and cisplatin and/or docetaxel and cisplatin. LP-100 has previously been in a genomic signature guided phase 2 clinical trial in Denmark for patients with metastatic castration resistant prostate cancer (mCRPC). 9 patients (out of a targeted enrollment of 27) were treated in the trial. The median overall survival (OS) for the initial group of 9 patients was approximately 12.5 months, which is an improvement over other similar fourth-line treatment regimens for mCRPC. Based on our evaluation of the synergies of LP-100 with PARP inhibitors, the decision was made in the first quarter of 2023 to close the phase 2 clinical trial in Denmark, to allow the focus of LP-100-directed resources on positioning the molecule for development in earlier lines of therapy with potentially larger market opportunities. LP-100 was previously out-licensed by us to Allarity Therapeutics A/S. In July 2021, we entered into an Asset Purchase Agreement to reacquire global development and commercialization rights for LP-100 from Allarity.

Our development strategy is to pursue an increasing number of oncology focused, molecularly targeted therapies where artificial intelligence and genomic data can help us provide biological insights, reduce the risk associated with development efforts and help clarify potential patient response. We plan on strategically evaluating these on a program-by-program basis as they advance into clinical development, either to be done entirely by us, or with licensing partners, to maximize the commercial opportunity and reduce the time it takes to bring the right drug to the right patient.

To date, except for a prior research grant, we have not generated any revenue, we have incurred net losses and our operations have been financed primarily by sales of our equity securities. Our net losses were approximately $3,329,000 and $4,537,000 for the three months ended March 31, 2026 and 2025, respectively.

Our net losses have primarily resulted from costs incurred in licensing and developing the drug candidates in our pipeline, planning, preparing and conducting preclinical studies and clinical testing, and general and administrative activities associated with our operations. We expect to continue to incur significant expenses and corresponding operating losses for the foreseeable future as we continue to advance our pipeline. Our costs may further increase as we conduct additional preclinical studies and clinical trials and potentially seek regulatory clearance for and prepare to commercialize our drug candidates. We expect to incur significant expenses to continue to build the infrastructure necessary to support our operations, preclinical studies, clinical trials, and potential commercialization, including manufacturing, marketing, sales and distribution functions. We have experienced and will continue to experience substantial costs associated with operating as a public company.

Components of Our Results of Operations

Revenues

We did not recognize revenues for the three-month periods ended March 31, 2026 and 2025.

Research and Development

Research and development expenses consist primarily of costs incurred for the research and development of our preclinical and clinical candidates, which include:

	●	expenses incurred towards research and development employees, consultants, outside contractors, laboratories, clinical sites, and investigators that conduct our preclinical or clinical research activities; and
	●	the cost of acquiring and developing preclinical and clinical study materials and lab supplies, including manufacturing costs related to our drug candidates.

We expense research and development costs to operations as incurred.

Our research and development expenses by project category for the three months ended March 31, 2026 and 2025 are as follows:

		Three Months				Three Months
		Ended March 31, 2026				Ended March 31, 2025
LP-300		$	683,289			$	1,007,908
LP-184			548,914				1,361,464
LP-284			219,943				456,471
RADR® Platform			209,470				253,579
Other *			63,256				184,533
Total research and development expenses		$	1,724,872			$	3,263,955

*	LP-100 and ADC Program expenses are included in "Other."

We expect that our research and development expenses will fluctuate from quarter to quarter and year to year. We expect that our research and development expenses will increase substantially over time based on the progress of our clinical trials for LP-300, LP-184 and LP-284, and other programs and drug candidates. We expect to make substantial expenditures associated with research and service provider agreements for the advancement of our drug candidates and research and development efforts.

Because of the numerous risks and uncertainties associated with product development, we cannot determine with certainty the duration and completion costs of these or other current or future clinical trials of LP-300, LP-184, LP-284 or our other drug candidates. We may never succeed in achieving regulatory approval for LP-300, LP-184, LP-284 or any of our other drug candidates. The duration, costs and timing of clinical trials and development of our drug candidates will depend on a variety of factors, including the uncertainties of future clinical and preclinical studies, uncertainties in clinical trial enrollment rates, significant and changing government regulation, and geopolitical risk, including in Taiwan where we are pursuing clinical testing of LP-300. In addition, the probability of success for each drug candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability.

General and Administrative

General and administrative expenses consist primarily of salaries and related costs for employees in executive, finance and administration, corporate development and administrative support functions, including stock-based compensation expenses and benefits. Other significant general and administrative expenses include accounting and legal services, insurance, the cost of various consultants, investor relations, occupancy costs, and information systems costs.

We expect fluctuating and increased administrative costs resulting from our existing and anticipated clinical trials and the potential commercialization of our drug candidates. We believe that these increases will likely include future increased costs for hiring additional administrative personnel to support future market research and future product commercialization efforts and increased fees for outside consultants, attorneys and accountants.

Summary Results of Operations for the Three Months Ended March 31, 2026 and 2025 (unaudited)

		Three Months Ended
		March 31,
		2026				2025
Operating expenses:
General and administrative		$	1,680,375			$	1,510,077
Research and development			1,724,872				3,263,955
Total operating expenses			3,405,247				4,774,032
Loss from operations			(3,405,247	)			(4,774,032	)
Interest income			42,160				149,790
Other income, net			33,916				87,459
NET LOSS		$	(3,329,171	)		$	(4,536,783	)

Comparison of the Three Months Ended March 31, 2026 and 2025

General and Administrative Expenses

General and administrative expenses increased approximately $170,000, or 11%, from approximately $1,510,000 for the three months ended March 31, 2025 to approximately $1,680,000 for the three months ended March 31, 2026. The increase was primarily attributable to increases in patent costs of approximately $99,000, increases in salaries and benefit expenses of approximately $71,000, and increases in business development and investor relations expenditures of approximately $36,000. These increases were partially offset by decreases in travel expenses of approximately $16,000 and rent of approximately $15,000.

Research and Development Expenses

Research and development expenses decreased approximately $1,539,000, or 47%, from approximately $3,264,000 for the three months ended March 31, 2025 to approximately $1,725,000 for the three months ended March 31, 2026. The decrease was attributable to reductions in research studies and materials costs of approximately $1,322,000 relating to the conduct and support of our clinical trials, and decreases in salaries and benefit expenses of approximately $246,000. These decreases were partially offset by increases in consulting expenses of approximately $16,000 and increases in licensing fees of approximately $12,000.

Interest and Other Income, Net

Interest income decreased approximately $108,000, or 72%, from approximately $150,000 for the three months ended March 31, 2025 to approximately $42,000 for the three months ended March 31, 2026. This decrease was primarily due to reductions in the amount of marketable securities held by us during the three months ended March 31, 2026 as compared to the three months ended March 31, 2025. Other income, net decreased approximately $53,000, or 61%, from approximately $87,000 for the three months ended March 31, 2025 to approximately $34,000 for the three months ended March 31, 2026. This decrease was primarily attributable to reductions in dividend income and other investment income of $23,000 and $90,000, respectively. These declines in other income, net, were offset, in part by an increase in foreign currency gains of approximately $60,000 during the three months ended March 31, 2026.

Cash Flows

The following table summarizes our cash flow for the periods indicated:

		For the Three Months Ended March 31,
		2026				2025
		(Unaudited)
Net cash flows used in operating activities		$	(3,772,627	)		$	(4,375,610	)
Net cash flows provided by investing activities			4,250,000				3,239,331
Effect of foreign exchange rates on cash			17,585				2,802
Net increase (decrease) in cash and cash equivalents		$	494,958			$	(1,133,477	)

Operating Activities

For the three months ended March 31, 2026, net cash used in operating activities was approximately $3,773,000 compared to approximately $4,376,000 for the three months ended March 31, 2025. The primary cause of the reduction in cash used is a decrease in net loss of approximately $1,208,000 during the three months ended March 31, 2026 when compared to the three months ended March 31, 2025. This reduction in cash used was offset, in part, by larger decreases in accounts payable and accrued expenses during the three months ended March 31, 2026 as compared to the three months ended March 31, 2025.

Investing Activities

For the three months ended March 31, 2026, net cash provided by investing activities was approximately $4,250,000 compared to approximately $3,239,000 of net cash provided by investing activities for the three months ended March 31, 2025. The increase in cash provided by investing activities is due to an increase in net redemptions of investments in marketable securities during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025.

Operating Capital and Capital Expenditure Requirements

As of March 31, 2026, we had total assets of approximately $7.2 million and working capital of approximately $3.3 million. As of March 31, 2026, our liquidity included approximately $6.3 million of cash, cash equivalents and marketable securities. We plan to pursue periodic capital raises and also plan to apply for grant funding in the future to assist in supporting our capital needs. In July 2025, we entered into the ATM with ThinkEquity, as sales agent, pursuant to which we may offer and sell shares of our common stock from time to time, in "at-the-market" offerings to or through our sales agent. No sales were made under the ATM during the three months ended March 31, 2026.

On May 12, 2026, we entered into a securities purchase agreement (the "Purchase Agreement") with institutional investors, pursuant to which we agreed to issue and sell to such investors in a registered direct offering (i) 1,454,175 shares common stock of the Company, at an offering price of $2.06 per share, and (ii) pre-funded warrants to purchase up to 681,748 shares of common stock (the "Pre-Funded Warrants") in lieu of the Common Shares, at an offering price of $2.0599 (such registered direct offering, the "Offering"). The Offering closed on May 14, 2026, and we received gross proceeds of approximately $4.4 million from the Offering, before deducting Offering expenses payable by us, including the fees of the placement agent for the Offering. In addition, in a concurrent private placement, we agreed to issue to such investors warrants to purchase up to 2,135,923 shares of common stock, at an exercise price of $2.27 per share. We may also explore the possibility of additional manners of offering our equity securities and entering into commercial credit facilities as an additional source of liquidity.

We believe that our cash, cash equivalents, and marketable securities on hand as of the date of this report, including the net proceeds from the Offering of shares of common stock and Pre-Funded Warrants, will enable us to fund our operating expenses and capital expenditure requirements until approximately the middle of the first quarter of 2027. We will need substantial additional capital to fund our operations beyond that time period, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our drug development programs or commercialization efforts.

Our ability to continue as a going concern is highly contingent on the ability to raise additional capital for ongoing research and development and clinical trials as we expect to continue incurring losses for the foreseeable future. The financial statements in this report have been prepared assuming that we will continue as a going concern, and do not include any adjustments that may be necessary should we be unable to continue as a going concern. We have incurred, and anticipate that we will continue to incur, losses and generate negative operating cash flows and as such will require substantial additional funding in the near future to continue our research and development activities. These factors raise substantial doubt about our ability to continue as a going concern in the absence of obtaining substantial additional funding. While we plan to pursue periodic capital raises, including additional potential sales under the ATM, no assurance can be given that sufficient funding will be available when needed to allow us to continue as a going concern.

We expect to incur significant, fluctuating and often increasing operating losses at least for the next several years as we continue our clinical development of LP-300, LP-184 and LP-284, pursue development of our other drug candidates and programs, and seek potential future marketing approval for our drug candidates, which could be several years in the future, if at all. We do not expect to generate revenue, other than anticipated revenue from withZeta.ai and possible license and grant revenue, unless and until we successfully complete development and obtain regulatory approval for our therapeutic candidates. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our existing and planned clinical trials and our expenditures on other research and development activities.

We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. We anticipate that our expenses will increase substantially as we:

	●	continue the development, including preclinical studies and clinical trials, of our drug candidates;
	●	initiate preclinical studies and clinical trials for any additional indications for our current drug candidates and any future drug candidates that we may pursue;
	●	continue to build our portfolio of drug candidates through the acquisition or in-license of additional drug candidates or technologies;
	●	continue to develop, maintain, expand and protect our intellectual property portfolio;
	●	pursue regulatory approvals for those of our current and future drug candidates that successfully complete clinical trials;
	●	ultimately establish a sales, marketing, distribution and other commercial infrastructure to commercialize any drug candidate for which we may obtain marketing approval;
	●	hire additional clinical, regulatory, scientific and accounting personnel;
	●	incur additional legal, accounting and other expenses in operating as a public company; and
	●	continue to develop, maintain, and expand our RADR® platform and AI and machine learning technologies.

We expect that we will need to obtain substantial additional funding in order to complete our clinical trials. To the extent that we raise additional capital through the sale of common stock, convertible securities or other equity securities, the ownership interests of our existing stockholders may be materially diluted and the terms of these securities could include liquidation or other preferences that could adversely affect the rights of our existing stockholders. In addition, debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. If we are unable to raise capital when needed or on attractive terms, we could be forced to significantly delay, scale back or discontinue the development or commercialization of LP-300, LP-184, LP-284, and/or other drug candidates and programs, seek collaborators at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available, and relinquish or license, potentially on unfavorable terms, our rights to LP-300, LP-184, LP-284, and/or other drug candidates and programs that we otherwise would seek to develop or commercialize ourselves.

Critical Accounting Estimates

There have been no changes to our critical accounting estimates during the three months ended March 31, 2026.

Quantitative and Qualitative Disclosure About Market Risk

Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. Fixed rate securities may have their market value adversely affected due to a rise in interest rates. Accordingly, our future investment income may fluctuate as a result of changes in interest rates, or we may suffer losses in principal if we are forced to sell securities that decline in market value as a result of changes in interest rates.

Historically, we have raised capital through the issuance of equity securities. We had no long-term debt outstanding as of March 31, 2026 and December 31, 2025.

We do not believe that our cash and cash equivalents have significant risk of default or illiquidity. Our cash and cash equivalents consist primarily of cash, U.S. treasury bills and money market funds. Our exposure to market risk relating to cash and cash equivalents due to changes in interest rates is limited because our cash and cash equivalents have a short-term maturity and are used primarily for working capital purposes. While we believe our cash, cash equivalents and marketable securities do not contain excessive risk, we cannot provide absolute assurance that in the future our investments will not be subject to adverse changes in market value. In addition, we maintain significant amounts of cash and cash equivalents at one or more financial institutions from time to time may be in excess of federally insured limits. Interest bearing and non-interest bearing accounts we hold at banking institutions are guaranteed by the Federal Deposit Insurance Corporation ("FDIC") up to $250,000. From time to time, some of our cash balances held at banking institutions may be in excess of FDIC coverage. We consider this to be a normal business risk.

We formed a wholly owned subsidiary, Lantern Pharma Australia Pty Ltd, in Australia in September 2021 and experienced foreign currency gains of approximately $77,000 and $17,000 for the three months ended March 31, 2026 and 2025, respectively, in connection with this subsidiary. We will remain subject to the risk of foreign currency losses in future periods, although we do not expect the impact of any foreign currency losses to be material. We do not participate in any foreign currency hedging activities, and we do not have any other derivative financial instruments.

Inflation generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect on our results of operations during the periods presented. Inflation could have a greater impact on our future results of operations if it remains at current levels or increases.