INTI 10-K & 10-Q changes, risk factors and insider trading

Our business is subject to numerous risks and uncertainties, including those typically associated with small, pre-revenue pharmaceutical development companies. Investors should carefully consider all risks described elsewhere in this Annual Report, including the following Part I-specific themes.

We may not obtain FDA agreement on our proposed development pathway. Although we have been granted a Type C meeting, FDA may disagree with our proposed endpoint framework, may require additional data or development work, may determine that the existing HP2001 dataset is not sufficient for filing, or may decline to support a 505(b)(2) pathway or expedited programs.

Our intellectual property strategy may not provide the protection or duration we expect. Patent applications related to our proprietary formulation may not issue, may issue with narrower claims than anticipated, may be challenged or may not provide meaningful commercial protection. Orphan-drug designation does not guarantee approval and exclusivity attaches only if statutory requirements are satisfied at approval.

Our commercial assumptions may not be realized. The economic analyses described in Item 1 are based on internal assumptions, literature sources and illustrative market scenarios. Actual pricing, reimbursement, penetration, partner interest and profitability could differ materially.

We may require additional capital or strategic transactions to realize the value of our program. Even if regulatory progress continues, we may be unable to raise funding or enter into a transaction on acceptable terms, or at all.

On February 19, 2026, we entered into a securities purchase agreement to sell 12 million shares of our common stock and to issue a common stock purchase warrant to purchase up to 7 million additional shares of common stock in exchange for proceeds of $3 million. If the warrant is exercised, additional proceeds of approximately $2.5 million would be received. There are no guarantees that this deal pursuant to the securities purchase agreement will close and there are no assurances that the warrants will be exercised. In this event, we may be required to delay, scale back or eliminate the development of business opportunities and our operations and financial condition may be adversely affected to a significant extent.

We might not be able to continue as a going concern.

Notwithstanding our conclusion that our current plans mitigate the substantial doubt about our ability to continue as a going concern, there is significant uncertainty regarding the timing and effect of the impact any public or private sale of equity or debt securities or from any other financing strategies. Accordingly, we cannot conclude it is probable we will be able to generate sufficient liquidity to continue as a going concern.

If we are required to raise additional funding in the future beyond our current plans to maintain our operations, we cannot be certain that additional capital, whether through selling additional equity or debt securities or obtaining a line of credit or other loan, will be available to us or, if available, will be on terms acceptable to us. If we issue additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of our common stock, and our current stockholders may experience dilution.

In October 2025, we entered into a performance-based master services agreement with Frameshift Management, Inc. (“Frameshift”) to provide regulatory, biostatistical and strategic consulting services supporting our lead development program targeting basal cell carcinomas associated with Gorlin Syndrome. Frameshift performs services under project-specific statements of work supporting our preparation of regulatory submissions, coordination of supporting analyses and overall advancement of our BCCNS development strategy.

Frameshift supported us in the preparation of a regulatory meeting request and associated briefing materials submitted to the FDA in February 2026 and is expected to assist in the preparation of materials supporting a potential NDA subject to regulatory feedback and the outcome of FDA discussions regarding our proposed development pathway

We have incurred losses and negative cash flows from operations and expect to incur additional losses until such time that we can generate significant revenue from the licensing of a product once we receive approval by FDA, which will allow for commercialization of the product candidate. During the year ended December 31, 2025, we incurred a net loss of $3.3 million and had negative operating cash flows of $3.2 million. Given our projected operating requirements and our existing cash and cash equivalents, we are projecting insufficient liquidity to sustain our operations through one year following the date that the financial statements are issued, before giving consideration to management’s plans to alleviate such conditions. These conditions and events raise substantial doubt about our ability to continue as a going concern.

In response to these conditions, management is currently evaluating the scope of our 2026 operations, including potential financing strategies that include, but are not limited to, the public or private sale of equity or debt securities or from loans or through other strategic collaboration and/or from licensing agreements. On February 19, 2026, we entered into a securities purchase agreement with an institutional investor, pursuant to which we agreed to sell and issue shares of common stock and warrants in a registered direct offering in exchange for proceeds of $3.0 million. The securities are subject to certain contractual restrictions on transfer, including a nine-month lock-up period. Once received, we intend to use the proceeds from the offering for working capital and other general corporate purposes.

We believe that the impact on our liquidity and cash flows resulting from the offering, once the proceeds are received, will mitigate some of the risk related to the substantial doubt about our ability to continue as a going concern. However, there can be no assurances that the proceeds will be received pursuant to the securities purchase agreement. Because our plans have not yet been fully executed and are not within our control, the implementation of such plans cannot be considered probable. As a result, we have concluded that our plans do not currently alleviate substantial doubt about our ability to continue as a going concern.

The FDA has not agreed with our previously proposed efficacy endpoint, and if it does not accept the surgically eligible endpoint we now propose we may be required to conduct additional clinical trials that we are not currently able to fund.

Our development strategy for itraconazole in BCCNS depends on the FDA accepting the rate and response of surgically eligible basal cell carcinomas, meaning those tumors that have reached the anatomic site-referenced size at which surgical excision is warranted, as an appropriate primary efficacy endpoint, and accepting our analyses of the completed HP2001 study, read against that endpoint, as adequate to support a marketing application under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. In written responses provided on May 5, 2026, the FDA did not agree that the per-lesion response rate we had previously proposed was an appropriate primary efficacy endpoint and recommended that we conduct a prospective, randomized, placebo-controlled trial. We submitted a further meeting request on July 10, 2026 proposing the surgically eligible endpoint and our proposed pathway, which the FDA has classified as a Type C meeting and to which it has elected to respond in writing rather than by meeting, with a stated goal date of the end of September 2026. The FDA is not obligated to agree with our position, and its prior comments indicate that it may not.

HP2001 was an open-label, single-arm study completed a number of years ago and did not include a concurrent control. We are proposing to evaluate its new-tumor data against the placebo arm of the randomized Tang trial as a historical external control. If the FDA does not accept that construction as adequate and well controlled, it may treat the evidence as uncontrolled or partially controlled; applicable regulations provide that such evidence may not serve as the sole basis for an effectiveness claim. The FDA may also conclude that our data are insufficient, that the endpoint is not adequately validated or clinically meaningful, or that additional clinical, nonclinical, pharmacokinetic, or chemistry, manufacturing and controls data are necessary. We may then be required to conduct one or more additional clinical trials before a marketing application could be submitted or approved. We do not currently have the capital required to conduct such a trial, and as described in Note 2 to our condensed financial statements there is substantial doubt about our ability to continue as a going concern. Any such requirement would materially delay, and could prevent, commercialization of our product candidate, and could require us to curtail, suspend or discontinue the program.

Itraconazole has demonstrated multiple antitumor mechanisms that provide a scientific rationale for its development in basal cell carcinoma (“BCC”). Investigators at Johns Hopkins University (“JHU”) identified itraconazole as an inhibitor of angiogenesis, demonstrating that it inhibits endothelial cell-cycle progression and blocks vascular endothelial growth factor (“VEGF”) and basic fibroblast growth factor (“bFGF”)-dependent formation of new blood vessels. Angiogenesis provides growing tumors with the vascular network required to deliver oxygen and nutrients. Human BCCs have been shown to possess an expanded microvascular bed compared with normal skin, including approximately 2.6-fold greater microvascular area, 2.0-fold greater microvessel length density and 3.9-fold greater red-cell flux. Accordingly, inhibition of angiogenesis may constrain the vascular support available to BCCs and contribute to itraconazole’s antitumor activity. Itraconazole has also demonstrated inhibition of Hedgehog signaling, a central driver of BCC tumorigenesis.

Itraconazole also exhibits substantial distribution into human skin. In a human pharmacokinetic study, skin tissue concentrations in the beard region and back were consistently higher than corresponding plasma concentrations after seven days of oral administration, while concentrations in sebum reached approximately ten times corresponding peak plasma concentrations. The study also demonstrated uptake of itraconazole by keratinocytes in the basal layer and prolonged persistence within keratinized skin tissues. We believe these distribution characteristics provide an additional pharmacologic rationale for investigating systemic itraconazole in cutaneous BCC.

In HP2001, no correlation was observed between serial trough plasma itraconazole concentrations and objective therapeutic response, and reductions in tumor measurements were not correlated with plasma itraconazole levels. Published human pharmacokinetic studies have shown that itraconazole distributes extensively into the skin following oral administration. Skin tissue concentrations can exceed corresponding plasma concentrations, itraconazole is taken up by keratinocytes in the basal layer of the epidermis, and concentrations in sebum have been reported at approximately ten times corresponding peak plasma concentrations. These findings provide a plausible explanation for why systemic plasma concentrations may not directly reflect drug exposure or activity at the cutaneous site of disease. The significance of this relationship has not been established, but it suggests that plasma concentrations alone may not be a reliable predictor of therapeutic response in BCCNS.

The primary efficacy endpoint we propose for this program is the rate and response of surgically eligible BCCs, meaning those tumors that have reached the anatomic site-referenced size at which surgical excision is warranted. This endpoint, which was the endpoint of the only randomized, placebo-controlled trial ever conducted in Gorlin syndrome, replaces the per-lesion response rate we had previously proposed to the FDA, and it is the basis on which we are seeking the Agency’s agreement that our existing clinical data may support a marketing application under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. See “Regulatory Developments and Proposed Development Pathway” below.

We engaged Avior Bio, Inc. (“Avior”) to develop novel oral formulations of itraconazole for our development program. As part of the formulation development program, Avior evaluated three itraconazole formulations in capsule format and assessed three prototype polymer compositions to create amorphous nano/microparticles using spray drying methods. The formulations were studied in a parallel group three-armed pre-clinical pharmacokinetic study in rats. The study included a formulation designed to mimic TOLSURA®, and two novel formulations developed to enhance itraconazole bioavailability. Each formulation was administered orally at an equivalent dose of 10 mg/kg. One of the novel formulations, AVF2-1, generated higher itraconazole plasma levels than the TOLSURA-mimicking formulation. Our provisional patent application covers the development of its amorphous nano/microparticle itraconazole formulations and the enhanced bioavailability observed in the rodent model. The claims are intended to protect the novel formulation and related methods of treatment informed by the efficacy results observed in the HP2001 study. In connection with any future New Drug Application (“NDA”), the Company intends to seek Orange Book listing of any issued formulation or composition patents that are eligible for listing.

Following the preclinical work, Avior completed further formulation development and manufactured two Inhibitor Therapeutics itraconazole capsules containing 65 mg and 75 mg of the selected itraconazole formulation. The purpose of selecting the specific dose strength was to demonstrate point estimate bio-similarities in Pharmacokinetic parameters to the observed HP2001 study. During 2026, we conducted a pilot, randomized, three-way crossover pharmacokinetic bioavailability study (ITZ101) in healthy adult subjects under fasting conditions comparing the two test formulations with TOLSURA® 65 mg as the reference product. Final study documentation was issued in July 2026.

The ITZ101 study demonstrated generally comparable pharmacokinetic profiles between the test formulations and the reference product, with the 75 mg formulation producing systemic exposure most comparable to TOLSURA. For the 75 mg formulation, the geometric mean ratios relative to TOLSURA for itraconazole AUC0-t and Cmax were 105.36% and 102.19%, respectively. The observed variability is consistent with the well-recognized pharmacokinetic characteristics of itraconazole, which has low aqueous solubility and historically variable oral absorption. Based on these results, we intend to advance a ~75 mg formulation in our development program. We expect the preclinical and human pharmacokinetic results generated through the Avior formulation development program to inform our ongoing regulatory strategy and discussions with the FDA regarding the development pathway for a potential NDA.

The pilot study described above is also intended to support the comparative bioavailability bridge between the itraconazole product used in our completed HP2001 study and our to-be-marketed formulation. We expect that such a bridge will be a required component of any marketing application submitted under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which permits an applicant to rely in part on the FDA’s previous findings of safety and effectiveness for a previously approved drug.

Commercial and Economic Considerations

We have also prepared an internal illustrative analysis of the potential economic burden associated with the management of BCCs in patients with BCCNS. Because management of the disease currently relies heavily on repeated Mohs surgery, excisions, biopsies and other tumor-directed procedures, the cost of care can increase substantially as tumor burden increases. Using published literature, publicly available U.S. self-pay cost benchmarks and assumed utilization ranges, our analysis estimates monthly procedural costs of approximately $2,000 to $3,500 for a patient during periods of relatively low tumor burden, approximately $4,500 to $7,500 during periods of moderate tumor burden and approximately $7,500 to more than $14,500 during periods of high tumor burden. These estimates are illustrative and do not represent actual claims experience, contracted payer reimbursement rates or the expected cost of care for any particular patient. Actual utilization and costs may vary materially based on tumor number, anatomical location, treatment modality, insurance coverage and other factors.

We have separately developed an illustrative internal commercial model to evaluate the potential economic opportunity associated with an approved systemic therapy for BCCNS. The model assumes an estimated U.S. BCCNS population of approximately 11,000 patients, approximately one-third market penetration, and illustrative pricing of $4,000 to $5,000 per patient per month. Under those assumptions, approximately 3,700 treated patients would correspond to potential peak annual U.S. revenue of approximately $178 million to $222 million. The model also considers a commercialization ramp, potential orphan-drug exclusivity, a post-exclusivity erosion period and potential formulation patent protection over a 20-year modeled lifecycle. These analyses were prepared for internal strategic planning purposes, are highly sensitive to the assumptions used and should not be interpreted as Company financial guidance, a forecast of future revenues, an estimate of fair value or an indication that FDA approval or any particular level of pricing, reimbursement, market penetration or commercial performance will be achieved.

Regulatory Developments and Proposed Development Pathway

The most significant development in our program during 2026 has been a change in the primary efficacy endpoint we propose for the registration of itraconazole in BCCNS. We now propose the rate and response of surgically eligible basal cell carcinomas, meaning those tumors that have reached the anatomic site-referenced size at which surgical excision is warranted, in place of the per-lesion response rate we had previously proposed to the FDA. This was a primary endpoint of the randomized, placebo-controlled oral-vismodegib trial reported by Tang and colleagues in the New England Journal of Medicine in 2012 (the “Tang Trial”), in which the hedgehog pathway inhibitor vismodegib was compared with placebo. We believe this endpoint is the appropriate measure of benefit in this disease because it measures the surgical burden the disease imposes on patients, who are otherwise managed by repeated surgical excision over a lifetime, rather than the response of any individual lesion.

In the Tang Trial, the rate of new surgically eligible tumors fell from approximately 29 per patient-year on placebo to approximately 2 per patient-year on vismodegib, and the mean number of surgical excisions per patient fell from 4.4 to 0.31, with medians of 1.0 and 0 and P less than 0.001 for both outcomes. We regard the accompanying reduction in actual surgeries as important, because it indicates that the endpoint measures the morbidity the disease imposes rather than a surrogate for it. The Tang Trial enrolled a substantially higher-burden population than HP2001, as entry required at least 10 surgically eligible tumors at entry or during the preceding two years and the placebo arm had a baseline mean of approximately 37 such tumors, against a baseline mean of approximately 7 in HP2001. Because the rate at which new tumors appear scales with the number a patient already carries, the Tang rates are evidence that the endpoint responds to treatment and are not a benchmark for the population we intend to treat, and we do not present a direct comparison between the Tang rates and the HP2001 rates below.

The change in endpoint followed our interactions with the FDA during 2026. In February 2026, we submitted a meeting request and associated briefing materials to the FDA in support of our development program. On May 5, 2026, the FDA provided written responses in lieu of a meeting. In those responses, the FDA did not agree that a per-lesion response rate was an appropriate primary efficacy endpoint, questioned whether a reduction in the size of an individual basal cell carcinoma is by itself clinically meaningful in a patient who may have many such tumors, and recommended that we conduct a prospective, randomized, placebo-controlled trial. Following receipt of those responses we substantially repositioned our development strategy to respond to the Agency’s comments.

As supporting evidence for the proposed endpoint, we have applied the same site-referenced size thresholds to the target lesions that were already present at baseline in our completed HP2001 study. HP2001 was an open-label, single-arm study of itraconazole in 38 patients with BCCNS in which 477 target basal cell carcinomas were measured over the course of the study. Among the baseline target lesions meeting those thresholds, 53.4% met the criteria for an objective response, defined as a reduction of at least 30% in longest diameter; 86.9% were controlled, meaning they responded or remained stable; and the mean best reduction in longest diameter was approximately 41%. This analysis measures the response of tumors that were already present, which is a different measure from the rate at which new surgically eligible tumors arise. We present it as supporting evidence and do not combine the two measures.

We have also applied the same thresholds to the tumors that arose during HP2001. Ten new surgically eligible basal cell carcinomas were identified in 7 of the 38 patients, a rate of approximately 0.21 per patient-year over 46.7 patient-years of protocol follow-up. Measured over the 37.8 patient-years during which patients were actually receiving itraconazole, the corresponding rate is approximately 0.27 per patient-year. Under a narrower definition used in later development programs in this disease, which counts nose and periorbital tumors separately, the figures are 9 tumors in 6 patients and approximately 0.19 per patient-year. These are observed single-arm rates and are not treatment effects.

Because Gorlin syndrome requires management over a patient’s lifetime, we believe the ability of a patient to remain on therapy is a central component of the clinical utility of any chronic treatment. In the Tang trial, discontinuation of vismodegib for adverse events was 27%, or 7 of 26 patients, at a mean follow-up of approximately 8 months, and 54%, or 14 of 26 patients, by approximately 18 months, with only 1 of 5 eligible patients remaining on treatment at 18 months. In HP2001, treatment-related discontinuation of itraconazole for adverse events was 13%, or 5 of 38 patients, over a median of approximately 7 months of on-drug exposure. At approximately comparable duration the comparison is therefore 13% for itraconazole against 27% for vismodegib. These figures are drawn from different studies, are measured on different time bases because the Tang percentages are reported against observation time while the HP2001 percentage is reported against on-drug exposure, and are not the product of a head-to-head comparison. Neither vismodegib nor sonidegib is approved for the treatment of basal cell carcinomas in Gorlin syndrome; each is approved only for advanced or metastatic basal cell carcinoma, and use in patients with Gorlin syndrome is off-label.

On July 10, 2026, we submitted a meeting request and associated briefing package to the FDA to discuss the clinical development of itraconazole for the treatment of surgically eligible basal cell carcinomas in patients with BCCNS. On July 23, 2026, the FDA granted the meeting request, classified the meeting as a Type C meeting, and determined that written responses would be the most appropriate means of responding to our questions, with the result that a meeting will not be scheduled. The FDA acknowledged receipt of our briefing package and stated that its goal date for providing written responses is by the end of September 2026. The FDA also noted that if it determines the materials in our briefing package are inadequate, it may cancel or reschedule the agreement to provide written responses, in which case a new meeting request would be required. Our briefing package sets out the proposed endpoint, the supporting analyses of the HP2001 data, our responses to the FDA’s May 5, 2026 comments, and the questions on which we are seeking the Agency’s guidance, including whether the existing data are adequate to support a marketing application under Section 505(b)(2).

The analyses described above are descriptive characterizations of measurements collected prospectively in a single-arm, open-label study. They are not the results of a controlled, hypothesis-testing comparison against a concurrent control, they have not been reviewed or accepted by the FDA, and they may not be predictive of the results of any future controlled study. There can be no assurance that the FDA’s written responses will be favorable, that they will be provided by the stated goal date, or that the FDA will agree with our proposed endpoint, our characterization of these analyses or our proposed regulatory pathway. If the FDA does not agree, we may be required to conduct one or more additional clinical trials before a marketing application could be submitted or approved, which would require substantial additional capital and would materially delay any potential commercialization. See Item 1A, “Risk Factors.”

For the six months ended June 30, 2026 compared to the six months ended June 30, 2025

Research and Development Expenses. We incurred $0.6 million of research and development expenses during each of the six months ended June 30, 2026 and June 30, 2025. The expenses are primarily internal personnel costs, consisting of salaries, benefits and other related costs, as well as amounts paid to third parties to support our research and development activities. We expect research and development expenses to continue to increase in the future, depending on the results from our regulatory interactions with the FDA.

General and Administrative Expenses. We incurred approximately $0.8 million in general and administrative expenses during each of the six months ended June 30, 2026 and June 30, 2025. During each of the six months ended June 30, 2026 and 2025, general and administrative expenses were comprised primarily of compensation costs of $0.4 million, professional services fees of $0.2 million, and insurance costs of $0.2 million.

Interest income. We earned $0.01 million and $0.08 million of interest income during the six months ended June 30, 2026 and June 30, 2025, respectively. The interest income is generated from deposits held in our depository accounts and the decrease is the result of less deposits within our money market account during the current period.