What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-03-13 compared with 2024-03-14 · 87 added, 66 removed, 152 unchanged (50% of the section changed)

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IT treatment, or treatment designed to contain a drug inside a tumor without spreading to the rest of the body, has been an objective of clinicians since discovery of chemotherapeutic agents.

The challenge with IT treatment approaches is that a tumor’s lipophilic, high fat, dense and pressurized microenvironment is incompatible with and does not absorb water-based products.

The challenge with IT treatment approaches is

that a tumor’s lipophilic, high fat, dense and pressurized microenvironment is incompatible with and does not absorb water-based products.

We believe that this drug delivery challenge limits the effectiveness of prior and current IT treatments, which involve injecting aqueous drugs into a tumor without sufficient consideration of the tumor environment (regardless of the drug’s mechanism or approach, i.e.

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The drug is also used widely in several other cancers including pancreatic and bile duct cancer.

sulfate was first approved in 1965 and is also approved in generalized Hodgkin’s disease, lymphocytic lymphoma, advanced carcinoma of the testis, and certain types of sarcoma.

Vinblastine sulfate was first approved in 1965 and is also approved in generalized Hodgkin’s disease, lymphocytic lymphoma, advanced carcinoma of the testis, and certain types of sarcomas.

The drug is also used in breast and lung cancer.

In 2017, we initiated clinical study IT-01 using INT230-6 in the United States under an IND authorized by the FDA and in Canada under a CTA approved by Health Canada.

Study IT-01 tested the safety and efficacy of INT230-6 in patients with refractory or metastatic cancers, and enrolled 110 patients in three arms:

In 2017, we initiated the IT-01 Study using INT230-6 in the United States under an IND authorized by the FDA and in Canada under a CTA approved by Health Canada.

The IT-01 Study tested the safety and efficacy of INT230-6 in patients with refractory or metastatic cancers, and enrolled 110 patients in three arms:

(i) INT230-6 used as a monotherapy, (ii) INT230-6 in combination with Merck’s Keytruda® (pembrolizumab), and (iii) INT230-6 in combination with BMS Yervoy® (ipilimumab).

We completed enrollment of IT-01 in June 2022, locked the IT-01 database in February 2023 and finalized the clinical study report in September 2023.

We completed enrollment of the IT-01 Study in June 2022, locked the database in February 2023 and finalized the clinical study report in September 2023.

We delivered the combination-specific reports and other information to our partners in the fourth quarter of 2023.

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There was also an increase in the T-cells repertoire relative to control.

In mid-2024, we intend on initiating the INVINCIBLE-3 Study in certain metastatic soft tissue sarcoma subtypes.

We plan to enroll 333 patients with an endpoint of overall survival.

Also in mid-2024, we intend on initiating IT-04.

The endpoint for the Phase 2 portion of the IT-04 study is the change in the pathological complete response rate for the combination compared to the SOC alone.

We expect to initiate the Phase 2 portion of the IT-04 study in mid-2024, which will provide data to size the Phase 3 portion of the IT-04 study.

In July 2024, we initiated and dosed our first patient in the INVINCIBLE-3 Study testing INT230-6 as a monotherapy compared to the SOC drugs in second-and third-line treatment for certain soft tissue sarcoma subtypes.

This study has been authorized by the FDA, Health Canada, the European Medicines Authority, and Australia's Therapeutics Goods Administration.

The trial is enrolling and being conducted in eight countries:

the US, Australia, Canada, France, Germany, Italy, Poland, and Spain.

Up to 60 sarcoma-focused hospitals and other centers are expected to participate from these countries.

We plan to enroll 333 patients and expect to complete enrollment in the first half of 2026, with an endpoint of overall survival.

In October 2024, in collaboration with SAKK, we initiated and dosed our first patient in the INVINCIBLE-4 Study to treat patients with localized TNBC.

We plan to enroll 54 patients and expect to complete enrollment by the end of the first quarter of 2026, and the endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone.

We have also successfully developed Phase 3 quality analytical methods for the three INT230-6 components and successfully manufactured a large-scale batch of INT230-6.

In a meeting with the FDA in the fourth quarter of 2023, we agreed on a CMC plan for Phase 3 and product registration for our three key ingredients and INT230-6.

If we successfully execute the agreed upon plan, the CMC portion of an NDA should be acceptable to the FDA for product approval and registration (subject to final NDA review).

If we successfully

execute the agreed upon plan, and expect that the CMC portion of an NDA should be acceptable to the FDA for product approval and registration (subject to final NDA review).

Since our inception in 2012, our operations have included business planning, hiring personnel, raising capital, building our intellectual property portfolio, and performing both research and development on our product candidates.

We have incurred net losses since inception and expect to incur net losses in the future as we continue our research and development activities.

To date, we have funded our operations primarily through approximately $54.5 million in cash received from the net proceeds of sales of our common stock, preferred stock and convertible notes.

As of December 31, 2023, we had approximately $8.6 million of cash and cash equivalents plus approximately $6.2 million in investments in U.S.

Treasury bills.

To date, we have funded our operations primarily through net proceeds received from issuances of our Common Stock , preferred stock and convertible notes.

As of December 31, 2024, we had approximately $2.6 million of cash and cash equivalents.

Since our inception, we have incurred significant operating losses.

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As of December 31, 2024 and 2023, we had an accumulated deficit of approximately $66.8 million and $50.5 million, respectively.

We expect to incur significant expenses and operating losses for the next several years.

See “Funding Requirements” below.

We expect our expenses to increase as we continue to:

• Initiate Phase 3 programs in sarcoma and/or breast cancer;

We expect to incur significant expenses and operating losses for the next several years as we continue to:

• Fund our INVINCIBLE-3 and INVINCIBLE-4 clinical studies;

• Incur manufacturing costs for additional GMP batches of our product candidates and enhancer molecules;

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Our ability to ultimately generate revenue to achieve profitability will depend heavily on the development, approval, and subsequent commercialization of our product candidates.

If we fail to become profitable or are unable to sustain

profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.

Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financing, or other capital sources, which may include collaborations with other companies or other strategic transactions.

Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the issuances of equity, debt financing, or other capital sources, which may include collaborations with other companies or other strategic transactions.

We may not be able to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all.

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Research and Development Expenses

Salaries and Benefits

Salaries and benefits include employee-related expenses such as salaries and related benefits for employees engaged in research and development functions.

Clinical Trial Expenses

• Salaries and Benefits Related Costs include employee-related expenses such as salaries and related benefits for employees engaged in research and development functions.

• Clinical Trial Expenses includes payments to third parties in connection with the clinical development of our product candidates, including CROs, and costs due to clinical trials for patient care.

Contract Manufacturing

• Contract Manufacturing includes:

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◦ Other costs such as shipping, storage, and analytical testing.

Scientific consulting costs related to non-employees involved in research, including statistical analysis, clinical trial operations, development of product manufacturing techniques, and internet research related to oncology and chemistry issues that may impact our preclinical or clinical research.

Stock-Based Compensation

Stock-based compensation is the expense related to stock options granted to employees and warrants granted to independent consultants engaged in research and development functions.

• Consulting costs related to non-employees involved in research, including statistical analysis, clinical trial operations, development of product manufacturing techniques, and internet research related to oncology and chemistry issues that may impact our preclinical or clinical research.

• Stock-based Compensation relates to stock options granted to employees and warrants granted to independent consultants engaged in research and development functions.

General and Administrative Expenses

Salaries and Benefits

Salaries and benefits include employee-related expenses such as salaries and related benefits for employees engaged in fund raising, management, and corporate administration functions.

Legal fees include to expenses for corporate, patent and trademark fees with outside law firms.

Accounting Fees

Accounting fees primarily include the cost of our independent auditors for our annual audit, quarterly reviews, and services related Securities and Exchange Commission filings, along with costs for income tax returns preparation, and the cost of maintaining our accounting system.

Consulting are services provided by non-employees for general and administrative tasks.

This includes human resources, finance, investor relations, board compensation, and internet support.

• Salaries and Benefits Related Costs include employee-related expenses such as salaries and related benefits for employees engaged in fund raising, management, and corporate administration functions.

• Legal Fees include expenses for corporate, patent and trademark fees with outside law firms.

• Audit Fees consist of fees billed for professional services rendered for the audit of our annual financial statements, review of our interim financial statements, comfort and consent letters.

• Consulting services provided by non-employees for general and administrative tasks, includes accounting, tax, human resources, finance, investor relations, board compensation, and internet support.

• Insurance includes directors and officers’ insurance, workers compensation insurance, product liability insurance, business insurance, employee and cyber liability insurance.

Other general and administrative costs include facility expenses, office supplies, computer related costs, public relations costs, recruiting costs and conferences.

Stock-Based Compensation

Stock-based compensation is the expense related to stock options granted to our employees and board members and warrants granted to our independent consultants who work in the general and administrative aspects.

• Other includes facility expenses, office supplies, computer related costs, public relations costs, recruiting costs and conferences.

• Stock-based Compensation relates to stock options granted to our employees and board members and warrants granted to our independent consultants who work in the general and administrative aspects.

Other income and expenses

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Accrued interest was converted into Common Stock upon commencement of our IPO.

We accumulated federal research and development tax credits in prior tax years that are recoverable through a refund of Social Security taxes paid in current fiscal periods.

Results of Operations

The following tables summarize our results of operations for the years ended December 31, 2024 and 2023 (in thousands):

Years Ended December 31, Change

Years Ended December 31,

2024 2023 Change

Operating expenses:

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Loss on debt extinguishment - (2,262) 2,262

Other 24 48 (24)

Other income, net 3 24 (21)

Net loss $ (16,268) $ (10,538) $ (5,730)

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Net loss attributable to common stockholders $ (16,268) $ (11,862) $ (4,406)

Years Ended December 31, Change

Years Ended December 31,

2024 2023 Change

Research and development expenses:

Salaries and benefits related costs $ 896 $ 1,180 $ (284)

Clinical trial expenses:

IT-01 Study (Phase 1/2 Metastatic Cancers) $ (128) $ 984 $ (1,112)

INVINCIBLE-2 Study (Phase 2 Breast) 233 402 (169)

INVINCIBLE-3 Study (Phase 3 Sarcoma) 6,225 578 5,647

INVINCIBLE-4 Study (Phase 2 Breast) 524 19 505

Other 223 4 219

Clinical trial expenses 7,077 1,987 5,090

Contract manufacturing 657 922 (265)

Salaries and benefits related costs 1,379 896 483

Consulting 143 267 (124)

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$ 10,496 $ 4,786 $ 5,710

Years Ended December 31, Change

Years Ended December 31,

2024 2023 Change

General and administrative expenses:

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Year Ended December 31, 2024 Compared to Year Ended December 31, 2023

Research and development expenses decreased $0.3 million or 7%, and were primarily due to the following:

• Salaries and benefits related costs decreased $0.3 million due to four research employees leaving the Company in 2022 and 2023, which was partially offset by two new hires in late 2023 and bonus increases.

• Clinical trial expenses in our IT-01 study decreased $1.4 million due to the completion of enrollment in this study in mid-2022.

This decrease was partially offset by $0.6 million in higher expenses for preliminary work related to our Phase 3 sarcoma study (IT-03).

• Contract manufacturing increased by $0.8 million due to costs for a new manufacturing batch of INT230-6 in 2023.

Research and development expenses increased $5.7 million or 119%, and were primarily due to the following:

• Salaries and benefits related costs increased $0.5 million due to two new employee hires in late 2023 and two additional employee hires in early 2024.

• Clinical trial expenses increased $5.1 million, primarily due to an increase of $5.6 million in the INVINCIBLE-3 Study in 2024, in which we enrolled our first patient in the third quarter of 2024, and to a lesser extent, an increase of $0.5 million in the INVINCIBLE-4 Study, in which we enrolled and dosed our first patient in the fourth quarter of 2024.

These increases were partially offset by a decrease of $1.1 million in our IT-01 Study due to the completion of enrollment in this study in mid-2022 and the completion of study-related costs in 2023.

• Contract manufacturing decreased by $0.3 million in 2024, as there were fewer INT230-6 batches manufactured compared to 2023.

• Stock-based compensation increased due to new option awards granted to new employees, and additional option awards granted to employees in 2024, compared to minimal option awards granted in 2023.

General and administrative expenses increased $2.6 million or 72%, and were primarily due to the following:

• Salaries and benefits related costs increased by $0.2 million due to salary and bonus increases and the hiring of a new chief financial officer in the fourth quarter of 2023, along with $0.3 million in higher stock-based compensation expense.

• Salaries and benefits related costs increased by $0.3 million primarily due to the hiring of our new chief financial officer in the fourth quarter of 2023.

• Insurance increased by $0.3 million due to the additional directors and officers insurance as a publicly held company.

• Higher accounting fees, consulting and other expenses were partially offset by lower legal fees, as we completed our IPO in mid-2023 and transitioned into a publicly traded company.

Interest income increased $0.3 million due to interest earned on higher cash and investment balances from our IPO in June 2023.

Interest expense decreased by $0.2 million due to convertible notes converting to common stock at the time of our IPO.

In addition, we also recognized a $2.3 million loss on debt conversion at the time of the IPO.

• Legal fees increased $0.3 million primarily due to the higher public company reporting-related costs incurred over the full 2024 calendar year, compared to the partial year of public company-related costs subsequent to the completion of our IPO in mid-2023.

• Accounting fees decreased slightly by $0.1 million primarily due lower annual audit fees compared to higher fees incurred in the year of our IPO.

• Consulting increased $0.3 million primarily due to higher board fees and investor relation expenses subsequent to the completion of our IPO in mid-2023.

• Stock-based compensation increased due to new option awards granted our new chief financial officer, and additional option awards granted to employees in 2024, compared to minimal option awards granted in 2023.

Interest income was relatively unchanged in 2024.

Interest expense incurred in 2023 was due to convertible notes outstanding in 2023, which converted to Common Stock at the time of our IPO.

In addition, at the time of conversion, we also recognized a $2.3 million loss on debt conversion.

At the time of our IPO, a preferred stock deemed dividend of $1.3 million was recognized, representing the value that was transferred to the Series B and C preferred stockholders upon triggering of anti-dilution provisions.

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As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements or other sources.

The sale of equity and convertible debt securities may result in dilution to our stockholders.

Additional capital may not be

available on reasonable terms, or at all.

If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, scale back or discontinue the development of our product candidates.

On July 3, 2024, we filed a universal shelf registration statement on Form S-3, which was declared effective by the SEC on July 11, 2024, on which we registered for sale up to $150 million of any combination of our Common Stock , preferred stock, debt securities, warrants, and/or units from time to time and at prices and on terms that we may determine, which included up to $15 million of Common Stock that we may issue and sell from time to time, through H.C.

Wainwright & Co., LLC (“Wainwright”) acting as our sales agent, pursuant to the sales agreement that we entered into with Wainwright on July 3, 2024 for our “at-the-market” equity program (the “ATM Agreement”).

On November 20, 2024, we filed a prospectus supplement to reduce the maximum we may sell and issue under the ATM Agreement to $7.0 million of Common Stock , not including shares previously sold under the ATM Agreement.

For the year ended December 31, 2024, we issued 51,820 shares of Common Stock under the Sales Agreement for net proceeds of $0.2 million.

On November 21, 2024, we entered into a Securities Purchase Agreement with a single healthcare focused institutional investor (the “Investor”), pursuant to which we agreed to issue and sell, in a registered direct offering directly to the Investor, 1,237,113 shares of Common Stock to the Investor, at a price of $2.425 per share, for aggregate gross proceeds of approximately $3.0 million before deducting the placement agents’ fees and related offering expenses.

In a concurrent private placement, we agreed to issue to the Investor Common Stock warrants to purchase up to 1,237,113 shares (the “Common Warrants”) at an exercise price of $2.95 per share.

Each Common Warrant will be exercisable six months from the issuance date and will expire five and one-half years from the issuance date.

We have financed our operations primarily through an initial investment from our founder, the issuance and sale of convertible debt notes, private equity financings, and the IPO, after which shares of our Common Stock began trading on Nasdaq under the symbol “INTS” on June 30, 2023.

As of December 31, 2023, our cash, cash equivalents and investments were approximately $14.8 million.

Based on our balances in cash, cash equivalents, and investments, we project to have sufficient cash to fund our current operating plan through the end of the first quarter of 2025.

As of December 31, 2024, our cash and cash equivalents were approximately $2.6 million.

Based on our balances in cash and cash equivalents, we project to have sufficient cash to fund our current operating plan through the end of the first quarter of 2025.

Accordingly, we will need to obtain substantial additional funding to continue our operations.

We cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.

The following table summarizes the net cash provided by (used in) operating activities and financing activities for the periods indicated (in thousands):

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Net cash used in operating activities $ (15,220) $ (7,205)

Net cash used in investing activities (6,023) —

Net cash provided by (used in) investing activities 6,354 (6,023)

Net cash provided by financing activities 2,900 20,472

Net increase (decrease) in cash and cash equivalents $ 7,244 $ (3,227)

Net (decrease) increase in cash and cash equivalents $ (5,966) $ 7,244

Operating Activities

Our cash used in operating activities for the year ended December 31, 2023 was $7.2 million, comprising of (i) our net loss of $10.5 million, as adjusted for $4.0 million in non-cash expenses (including $2.3 million for the conversion of convertible notes into shares of common stock, and $1.4 million for non-cash stock based compensation), and (ii) net changes in operating assets and liabilities of $0.6 million.

Our cash used in operating activities for the year ended December 31, 2022 was $5.5 million, comprising of (i) our net loss of $7.6 million, as adjusted for $1.3 million in non-cash expenses (including non-cash stock based compensation of $1.2 million), and (ii) net changes in operating assets and liabilities of $0.8 million.

Our cash used in operating activities for the year ended December 31, 2024 was $15.2 million, comprising of (i) our net loss of $16.3 million, as adjusted for $3.1 million in non-cash expenses (including $3.1 million for non-cash stock based compensation), and (ii) net changes in operating assets and liabilities of $2.1 million.

Our cash used in operating activities for the year ended December 31, 2023 was $7.2 million, comprising of (i) our net loss of $10.5 million, as adjusted for $4.0 million in non-cash expenses (including $2.3 million for the conversion of convertible notes into shares of Common Stock , and $1.4 million non-cash stock based compensation), and (ii) net changes in operating assets and liabilities of $0.6 million.

Investing Activities

Our cash provided in investing activities during the year ended December 31, 2024 totaled approximately $6.4 million and was primarily due to net redemptions of marketable debt securities (net of purchases of marketable debt securities).

Our cash used in investing activities during the year ended December 31, 2023 totaled approximately $6.0 million and was primarily due to net purchases of marketable debt securities (net of redemptions of marketable debt securities).

There was no cash provided by or used in investing activities for the year ended December 31, 2022.

Financing Activities

Our cash provided by financing activities during the year ended December 31, 2024 was $2.9 million, primarily comprising of net proceeds of $2.4 million from our registered direct offering in 2023, net proceeds of $0.2 million from issuances of Common Stock from our ATM, and $0.3 million in proceeds from exercises of options and warrants.

Our cash provided by financing activities during the year ended December 31, 2023 was $20.5 million, primarily comprising of net proceeds of $20.2 million from our IPO in 2023, and $0.2 million from the sale of convertible notes prior to the IPO.

Our cash provided by financing activities during the year ended December 31, 2022 was $2.3 million from the issuance of convertible notes.

Off-Balance Sheet Arrangements

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Critical Accounting Policies and Estimates

Our management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or U.S.

The preparation of our financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements.

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Research and development costs are expensed as incurred.

We record the estimated CRO, CMO, and patient care costs as services are provided but not yet invoiced and include these costs in the accrued expenses in the balance sheet and within research and development expense in the statement or operations.

Equity-Based Compensation

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Therefore, we estimate our expected share price volatility based on the historical volatility of publicly traded peer companies and expect to continue to do so until such time as we have adequate historical data regarding the volatility of our own traded share price.

Recent Accounting Pronouncements

The Financial Accounting Standards Board has issued certain accounting pronouncements as of December 31, 2024 that will become effective in subsequent periods;

however, we do not believe that any of those pronouncements would have significantly affected our financial accounting measurements or disclosures had they been in effect during 2024, or that they will have a significant impact on us at the time they become effective.

JOBS Act Accounting Election

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.

We are an “emerging growth company,” as defined in the JOBS Act.

Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies.

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QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

We are not required to provide the information required by this Item as we are a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis