Quarterly Report for Quarter Ending June 30, 2026 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations.

CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS

Some of the statements in this Quarterly Report on Form 10-Q are "forward-looking statements" within the meaning of the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our current beliefs, goals and expectations about matters such as our expected financial position and operating results, our business strategy and our financing plans. The forward-looking statements in this report are not based on historical facts, but rather reflect the current expectations of our management concerning future results and events. The forward-looking statements generally can be identified by the use of terms such as "believe," "expect," "anticipate," "intend," "plan," "foresee," "may," "guidance," "estimate," "potential," "outlook," "target," "forecast," "likely" or other similar words or phrases. Similarly, statements that describe our objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be different from any future results, performance and achievements expressed or implied by these statements. We cannot guarantee that our forward-looking statements will turn out to be correct or that our beliefs and goals will not change. Our actual results could be very different from and worse than our expectations for various reasons. You should carefully review all information, including the discussion of risk factors under "Part I. Item 1A: Risk Factors" and "Part II. Item 7: Management's Discussion and Analysis of Financial Condition and Results of Operations" of the Form 10-K for the year ended December 31, 2025. Any forward-looking statements in the Form 10-Q are made only as of the date hereof and, except as may be required by law, we do not have any obligation to publicly update any forward-looking statements contained in this Form 10-Q to reflect subsequent events or circumstances.

Overview

We are a clinical stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology products based on our proprietary Tri-specific Killer Engager ("TriKE®"), and Tetra-specific Killer Engager ("Dual Targeting TriKE®") fusion protein immune cell engager technology platforms. Our TriKE® and Dual Targeting TriKE® platforms generate proprietary therapeutics designed to harness and enhance the cancer killing abilities of a patient's own natural killer cells, (" NK cells"). Once bound to an NK cell, our moieties are designed to activate the NK cell to direct it to one or more specifically targeted proteins expressed on a specific type of cancer cell or virus infected cell, resulting in the targeted cell's death. TriKE®s can be designed to target any number of tumor antigens, including B7-H3, HER2, CD33 and PDL1, on hematologic malignancies or solid tumors and do not require patient-specific customization. We believe our TriKE® and Dual Targeting TriKE® platforms that activate endogenous NK cells are potentially safer than T-cell immunotherapy because there is less cytokine release syndrome (CRS) and fewer neurological complications. Our preclinical data suggests that this is explained by the TriKE® dependent CD16 directed IL-15 proliferation of NK cells, with little effect on endogenous T cells.

We are using our TriKE® platform with the intent to bring to market immuno-oncology products that can treat a range of hematologic malignancies, solid tumors, and potentially autoimmune disorders. The platform is scalable, and we are implementing processes to produce investigational new drug ("IND") ready moieties in a timely manner after a specific TriKE® conceptual design. Specific drug candidates can then be advanced into the clinic on our own or through potential collaborations with partnering companies. We believe our TriKE®s may have the ability, if approved for marketing, to be used as both monotherapy and in combination with other standard-of-care therapies.

Our initial work was conducted in collaboration with the Masonic Cancer Center at the University of Minnesota under a program led by Dr. Jeffrey Miller, Professor of Medicine, and the Interim Director at the Masonic Cancer Center. Dr. Miller, who also serves as our Consulting Senior Medical Director, is a recognized key opinion leader in the field of NK cell and IL-15 biology and their therapeutic potential. We have exclusive rights to the TriKE® platform and are generating additional intellectual property for specific moieties.

Our current product candidate pipeline (as of June 30, 2026) is summarized in the table below:

GTB-3550

GTB-3550 was our first TriKE® product candidate and its clinical development was suspended so that we could focus resources on second-generation TriKEs®. GTB-3550 is a tri-specific killer engager, or TriKE, comprised of two single-chain variable fragments ("scFv") composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. We studied this anti-CD16-IL-15-anti-CD33 TriKE® in CD33 positive leukemias, a marker expressed on tumor cells in acute myelogenous leukemia ("AML") and myelodysplastic syndrome ("MDS"). The anti-CD33 antibody fragment in GTB-3550 was derived from the M195 humanized anti-CD33 scFv. We believe the approval of the antibody-drug conjugate gemtuzumab validates the targeting of CD33.

We previously announced the interim clinical trial results for GTB-3550, which showed significantly reduced CD 33+ bone marrow blast levels by 33.3%, 61.7%, 63.6%, 50% in Patient 5 (25 µg/kg/day), Patient 7 (50 µg/kg/day), Patient 9 (100 µg/kg/day), and Patient 11 (150 µg/kg/day), respectively. After the end of infusion, GTB-3550 and IL-15 concentrations declined rapidly with overall geometric mean terminal phase elimination half-life (T1/2) of 2.2 and 2.52 hours, respectively. There was minimal CRS resulting from hyperactivation of patient's T-cell population at doses 5-150 µg/kg/day.

Despite the positive interim clinical trial results, GTB-3550 was replaced by a more potent next-generation camelid nanobody TriKE®, GTB-3650, that similarly targets CD33 on relapsed/refractory AML and high-risk MDS. A key difference between GTB-3550 and GTB-3650 is the incorporation of camelid antibody technology instead of a scFv; our preclinical experience showed markedly enhanced potency of TriKEs® comprised of camelid components. This is illustrated below by better tumor control of AML bearing animals with GTB-3650 (purple dots) compared to GTB-3550 (blue dots). This provided the rationale for pausing further development of GTB-3550 and moving over to solely develop the second-generation, camelid-based TriKE® platform.

Second Generation TriKE^®s Utilize Camelid Nanobody Technology

Our goal is to be a leader in immuno-oncology therapies targeting a broad range of indications including hematological malignancies and solid tumors. A key element of our strategy includes introducing a next-generation camelid nanobody platform. Camelid antibodies (often referred to as nanobodies) are smaller than human immunoglobulin, consisting of two heavy chains instead of two heavy and two light chains. These nanobodies have the potential to have greater affinity to target antigens, potentially resulting in greater potency. We are utilizing this camelid antibody structure for all of our new TriKE® product candidates.

To develop second generation TriKE®s, we designed a new humanized CD16 engager derived from a single-domain antibody. While scFvs consist of a heavy and a light variable chain joined by a linker, single-domain antibodies consist of a single variable heavy chain capable of engaging without the need of a light chain counterpart (see figure below).

These single-domain antibodies are thought to have certain attractive features for antibody engineering, including physical stability, ability to bind deep grooves, and increased production yields, amongst others. Pre-clinical studies demonstrated increased NK cell activation against CD33+ targets including enhanced NK cell degranulation (% CD107a+) and IFNγ with the single-domain CD16 TriKE® (cam 16-wt15-33; GTB-3650) compared to the original TriKE® (scFv16-m 15-33; GTB-3550) (see figure below). This data was published by Dr. Felices M et al (2020) in Cancer Immunol Res.

CD33+ HL60 Targets in Killing Assays

The purple line represents the GTB-3650 and the blue line represents GTB-3550.

GTB-3650

GTB-3650 is a TriKE® which targets CD33 on the surface of myeloid leukemias and an agonistic camelid engager to the potent activating receptor on NK cells, CD16. Use of this engager enhances the activity of wild type IL-15 included in GTB-3650. The TriKE® approach provides a novel way to specifically target these tumors by leveraging NK cells, which have been shown to mediate relapse protection in this setting, in an anti-CD33-targeted fashion. We are advancing GTB-3650 to clinical studies based on pre-clinical data showing a marked increase in potency compared to GTB-3550, which we anticipate could lead to an enhanced efficacy signal in AML and MDS. We advanced GTB-3650 through requisite preclinical studies and filed an IND application with the U.S. Food and Drug Administration (the "FDA") in December 2023. In late June 2024, the FDA cleared our IND Application for GTB-3650. We started study enrollment targeting patients with relapsed/refractory AML and high grade MDS on January 21, 2025, and we have advanced into the clinic with the first 4 cohorts now enrolled. This initial study is testing GTB-3650 as monotherapy testing administration 2 weeks on and two weeks off (to prevent NK cell exhaustion) for at least 2 cycles of therapy, as agreed on with the FDA.

GTB-5550

GTB-5550 is a B7-H3 targeted TriKE® which targets B7-H3 on the surface of advanced solid tumors (figure above). GTB-5550 is our first dual camelid TriKE®. B7-H3 is expressed on a broad spectrum of solid tumor malignancies, allowing our team to target these malignancies through GTB-5550. Pre-clinical work has shown that this molecule has NK-cell targeted activity against a variety of solid tumors, including head and neck cancer squamous cell carcinoma (figure below), prostate cancer, breast cancer, ovarian cancer, glioblastoma, and lung cancer (amongst others).

We advanced GTB-5550 through requisite preclinical studies and filed an IND application with the FDA in October 2023 with a written response from the FDA in December 2023. The main question from the FDA was regarding pre-clinical toxicology and a pivot to subcutaneous dosing. In early January 2026, the FDA cleared our IND Application for GTB-5550, and our first patient was dosed in May 2026. The initial trial is designed as a basket trial for patients with B7-H3+ solid tumors using Monday through Friday dosing (2 weeks on and 2 weeks off to prevent immune exhaustion).

GTB-7550

GTB-7550 TriKE® is a product candidate in development for the treatment of lupus and other autoimmune disorders. GTB-7550 TriKE® is a tri-specific molecule composed of a camelid nanobody that binds the CD16 receptor on NK cells, a scFv engager against CD19 on malignant and normal B cells, and a human IL-15 sequence between them.

Published data shows that GTB-7550 effectively targets CD19+ malignant cell lines and primary chronic lymphocytic leukemia. Preliminary data shows that GTB-7550 can target and eliminate normal B cells, which we are continuing to test in mice. We are currently exploring and assessing potential manufacturers of GTB-7550.

Critical Accounting Policies

The preparation of our financial statements in conformity with accounting principles generally accepted in the United States ("GAAP") requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. When making these estimates and assumptions, we consider our historical experience, our knowledge of economic and market factors and various other factors that we believe to be reasonable under the circumstances. Actual results may differ under different estimates and assumptions. The accounting estimates and assumptions discussed in this section are those that we consider to be the most critical to gain an understanding of our financial statements because they inherently involve significant judgments and uncertainties.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates include accruals for potential liabilities, assumptions used in deriving the fair value of warrant liabilities, valuation of equity instruments issued for services, and valuation of deferred tax assets. Actual results could differ from those estimates.

Stock-Based Compensation

We periodically issue stock-based compensation to officers, directors, employees, and consultants for services rendered. Such issuances vest and expire according to terms established at the issuance date.

Stock-based payments made to officers, directors, employees, and consultants in exchange for goods and services, including grants of employee stock options, are recognized in the financial statements based on their grant date fair values in accordance with ASC 718, Compensation-Stock Compensation. Stock based payments to officers, directors, employees, and consultants, which are generally time vested, are measured at the grant date fair value and depending on the conditions associated with the vesting of the award, compensation cost is recognized on a straight-line or graded basis over the vesting period. Recognition of compensation expense for non-employees is in the same period and manner as if we had paid cash for the services. The fair value of stock options granted is estimated using the Black-Scholes option-pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected life, and future dividends. The assumptions used in the Black-Scholes option pricing model could materially affect compensation expense recorded in future periods.

Results of Operations

Comparison of the Three and Six Months Ended June 30, 2026 and 2025

Operating Expenses

		Three Months Ended June 30,
		2026				2025				$ Change				% Change
Operating Expenses:
Research and development		$	1,055,000			$	363,000			$	692,000				191	%
Selling, general and administrative			3,411,000				1,146,000				2,265,000				198	%
Stock compensation			46,000				4,000				42,000				1,050	%
Total Operating Expenses		$	4,512,000			$	1,513,000			$	2,999,000				198	%

		Six Months Ended June 30,
		2026				2025				$ Change				% Change
Operating Expenses:
Research and development		$	1,468,000			$	1,462,000			$	6,000				-	%
Selling, general and administrative			5,800,000				1,976,000				3,824,000				194	%
Stock compensation			92,000				7,000				85,000				1,214	%
Total Operating Expenses		$	7,360,000			$	3,445,000			$	3,915,000				114	%

Research and Development Expenses

Research and development expenses increased by approximately $0.7 million for the three months ended June 30, 2026 compared to the same prior year period, primarily due to an increase in materials and production costs.

Research and development expenses remained relatively flat for the six months ended June 30, 2026 compared to the same prior year period.

Research and development expenses relate to our continued licensing, development, production, and clinical trials of our most advanced TriKE® product candidates GTB-3650 and GTB-5550 along with the progression on other promising candidates. In late June 2024, we received clearance from the FDA with respect to our IND Application in relation to our next generation GTB-3650 camelid nanobody product. Study enrollment began in early 2025 and we have advanced into the clinic with the first 4 cohorts now enrolled. In late January 2026, we received clearance from the FDA with respect to our IND Application in relation to GTB-5550, with a Phase 1 dose escalation basket trial with the first patient dosed in May 2026.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased by approximately $2.3 million and $3.8 million for the three and six months ended June 30, 2026, respectively, compared to the same prior year periods, primarily due to an increase in marketing expenses, and to a lesser extent, legal and consulting fees.

Other Income (Expense)

		Three Months Ended June 30,
		2026				2025				$ Change				% Change
Other Income (Expense):
Interest income		$	58,000			$	38,000			$	20,000				53	%
Interest expense			(64,000	)			-				(64,000	)			-	%
Loss on initial recognition of Greenshoe Rights liability			-				(28,736,000	)			28,736,000				100	%
Change in fair value of warrant liability			-				(114,000	)			114,000				100	%
Other income			-				156,000				(156,000	)			(100	)%
Total Other Income (Expense)		$	(6,000	)		$	(28,656,000	)		$	28,650,000				100	%

		Six Months Ended June 30,
		2026				2025				$ Change				% Change
Other Income (Expense):
Interest income		$	125,000			$	70,000			$	55,000				79	%
Interest expense			(127,000	)			-				(127,000	)			-	%
Loss on initial recognition of Greenshoe Rights liability			-				(28,736,000	)			28,736,000				100	%
Change in fair value of warrant liability			11,000				12,000				(1,000	)			(8	)%
Gain on settlement of vendor payable			-				998,000				(998,000	)			(100	)%
Other income			-				156,000				(156,000	)			(100	)%
Total Other Income (Expense)		$	9,000			$	(27,500,000	)		$	27,509,000				100	%

Loss on initial recognition of Greenshoe Rights liability

The Greenshoe Rights connected to the Series L Preferred Stock issued in the May 2025 equity offering contained a pricing reset feature that required classification as a liability and marked to market at each reporting date as required under GAAP.

Gain on Settlement of Vendor Payable

In March 2025, a legal services firm currently engaged by the Company agreed to reduce the Company's prior year unpaid fees by approximately $1 million.

Net Loss

		Three Months Ended June 30,
		2026				2025				$ Change				% Change
Net Loss		$	(4,518,000	)		$	(30,169,000	)		$	25,651,000				85	%

		Six Months Ended June 30,
		2026				2025				$ Change				% Change
Net Loss		$	(7,351,000	)		$	(30,945,000	)		$	23,594,000				76	%

Net loss decreased by approximately $25.7 and $23.6 million for the three and six months ended June 30, 2026, respectively, compared to the same prior year periods, primarily due to the prior year loss on initial recognition of Greenshoe Rights liability of $28.7 million which did not occur in the current period, slightly offset by an increase in selling, general and administrative expenses, as described above.

Liquidity and Going Concern Analysis

The accompanying unaudited condensed financial statements have been prepared assuming that we will continue as a going concern. We do not have any product candidates approved for sale and have not generated any revenue from our product sales. We have sustained operating losses since inception, and we expect such losses to continue into the foreseeable future. Historically, we have financed our operations through public and private sales of Common Stock, the issuance of preferred stock and Common Stock, the issuance of convertible debt instruments, and strategic collaborations. For the six months ended June 30, 2026, we recorded a net loss of approximately $7.4 million and used cash in operations of approximately $6.7 million. These factors raise substantial doubt about our ability to continue as a going concern within one year of the date that the financial statements are issued. In addition, the Company's independent registered public accounting firm, in its report on the Company's December 31, 2025 financial statements, raised substantial doubt about the Company's ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

Cash Flows

		Six Months Ended June 30,
		2026				2025
Statements of Cash Flow Data:
Net cash used in operating activities		$	(6,728,000	)		$	(5,216,000	)
Net cash provided by investing activities			-				-
Net cash provided by financing activities			4,877,000				6,493,000
Net increase (decrease) in cash and cash equivalents and restricted cash			(1,851,000	)			1,277,000
Cash and cash equivalents and restricted cash, beginning of period			6,905,000				4,044,000
Cash and cash equivalents and restricted cash, end of period		$	5,054,000			$	5,321,000

Operating Activities

Net cash used in operating activities was approximately $6.7 million for the six months ended June 30, 2026 and was primarily due to a net loss of $7.4 million.

Net cash used in operating activities was approximately $5.2 million for the six months ended June 30, 2025 and was primarily due to a net loss of $30.9 million and a decrease in accounts payable and accrued expenses of approximately $1.6 million, offset by a non-cash loss on initial recognition of Greenshoe Rights liability of $28.7 million.

Financing Activities

Net cash provided by financing activities was approximately $4.9 million and $6.5 million for the six months ended June 30, 2026 and 2025, respectively, and resulted primarily from net proceeds from issuance of Series L Preferred Stock and exercise of warrants.

Working Capital

The following table summarizes total current assets, liabilities, and working capital for the periods ended June 30, 2026 and December 31, 2025:

		As of
		June 30, 2026				December 31, 2025				Increase/(Decrease)
Current assets		$	5,788,000			$	8,106,000			$	(2,318,000	)
Current liabilities		$	2,219,000			$	2,319,000			$	(100,000	)
Working capital		$	3,569,000			$	5,787,000			$	(2,218,000	)

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements as of June 30, 2026.