Indaptus Therapeutics, Inc.

Previous wording

As of October 2024, we completed one month of the weekly dosing part in the first six participants at the 3 x 10^7 Decoy20 dose and following the review of the safety data by the Safety Review Committee we received the authorization to initiate unrestricted enrollment of participants at the 3 x 10^7 Decoy20 dose. By May 2025, we had enrolled 13 participants on Decoy20 as a single dose and 32 participants in the weekly dosing among the two Decoy20 dose levels. In May 2025, we decided to conclude enrollment in the weekly dosing and focus on the combination study of Decoy20 with Tislelizumab, as further described below. We have observed early signs of potential benefits emerging with some participants with stable disease. As expected with the mechanism of action of Decoy20, we have seen adverse events of cytokine release syndrome (CRS) in 6 participants that have resolved within 24-72 hours.

Current wording

As of October 2024, we completed one month of the weekly dosing part in the first six participants at the 3 x 10^7 Decoy20 dose and following the review of the safety data by the Safety Review Committee we received the authorization to initiate unrestricted enrollment of participants at the 3 x 10^7 Decoy20 dose. By May 2025, we had enrolled 13 participants on Decoy20 as a single dose and 32 participants in the weekly dosing among the two Decoy20 dose levels. In May 2025, we decided to conclude enrollment in the weekly dosing and focus on the combination study of Decoy20 with Tislelizumab, as further described below. We have observed early signs of potential benefits emerging with some participants with stable disease. As expected with the mechanism of action of Decoy20, we have seen adverse events of cytokine release syndrome (CRS) in six participants that have resolved within 24-72 hours.

Previous wording

In October 2024, we entered into a clinical supply agreement, or the Supply Agreement, with BeOne Medicines (formerly known as BeiGene Switzerland GmbH), to advance clinical evaluation of Decoy20 in combination with BeOne’s anti-PD-1 antibody, Tislelizumab, or the BeOne Product, for the treatment of participants with advanced solid tumors, or the Combination Study. This Combination Study builds on preclinical results where Decoy20, combined with a PD-1 inhibitor, demonstrated tumor eradication. In June 2025 we announced the dosing of the first participant in the Combination Study and by August 2025 we had enrolled 6 participants, and we have seen one related serious adverse event of CRS in 1 participant that has resolved within 72 hours. The Combination Study will assess safety, dose optimization, and early signs of anti-tumor activity in participants with advanced solid tumors, previously treated with a checkpoint inhibitor or with tumors typically unresponsive to checkpoint inhibitors.

Current wording

In October 2024, we entered into a clinical supply agreement, or the Supply Agreement, with BeOne Medicines (formerly known as BeiGene Switzerland GmbH), to advance clinical evaluation of Decoy20 in combination with BeOne’s anti-PD-1 antibody, Tislelizumab, or the BeOne Product, for the treatment of participants with advanced solid tumors, or the Combination Study. This Combination Study builds on preclinical results where Decoy20, combined with a PD-1 inhibitor, demonstrated tumor eradication. By November 2025, we had enrolled six evaluable participants in the Combination Study, and we have seen one related serious adverse event of CRS in one participant that has resolved within 72 hours. Following efficacy evaluations, we had three participants who experienced disease progression and had to discontinue from the study, and we had evidence of stable disease at the first re-staging assessment in three subjects. Of the three stable disease participants, one subject developed disease progression at the next restaging assessment and has discontinued from the study; one subject continues dosing with Decoy20 alone with stable disease - this subject developed an immune-related adverse event and has not been receiving tislelizumab since the emergence of that adverse event; and the third subject continues dosing with both Decoy20 and tislelizumab with stable disease and is scheduled for further re-staging assessments. The Safety Review Committee has reviewed all available safety data from this cohort and determined that the Decoy20 and tislelizumab combination appears to be tolerable at the current dose and schedule. The Combination Study will assess safety, dose optimization, and early signs of anti-tumor activity in participants with advanced solid tumors, previously treated with a checkpoint inhibitor or with tumors typically unresponsive to checkpoint inhibitors. Currently, we have paused enrollment pending additional efficacy evaluations of the remaining participants and to further assess our next development options.

Previous wording

Research and development expenses were approximately $2.2 million for the three months ended June 30, 2025, compared to approximately $1.7 million for the three months ended June 30, 2024, representing an increase of approximately $0.5 million, or 26.4%. The increase was primarily driven by higher clinical trial costs of approximately $0.8 million related to our ongoing Phase 1 study. This increase was partially offset by a decrease of approximately $0.3 million in payroll and related expenses.

Current wording

Research and development expenses were approximately $1.52 million for the three months ended September 30, 2025, compared to approximately $1.47 million for the three months ended September 30, 2024, representing an increase of approximately $50,000, or 3.5%. The change was primarily driven by higher clinical trial costs of approximately $0.35 million related to our ongoing Phase 1 study. This increase was partially offset by a decrease of approximately $0.3 million in payroll and related expenses and stock-based compensation.

Previous wording

General and administrative expenses were approximately $4.0 million for the six months ended June 30, 2025, compared to approximately $4.7 million for the six months ended June 30, 2024, representing a decrease of approximately $0.7 million, or 14.7%. The decrease was primarily attributable to a reduction of approximately $1.5 million in stock-based compensation, payroll and related expenses, legal fees, and investor relations costs. This decrease was partially offset by an increase of approximately $0.8 million in transaction-related expenses associated with the private placement of convertible notes and warrants completed in June 2025.

Current wording

General and administrative expenses were approximately $1.1 million for the three months ended September 30, 2025, compared to approximately $1.7 million for the three months ended September 30, 2024, representing a decrease of approximately $0.6 million, or 32.5%. The decrease was primarily attributable to a reduction of approximately $0.7 million in stock-based compensation, payroll and related expenses, board of directors fees, investor relations costs and directors and officers insurance policy. This decrease was partially offset by an increase of approximately $0.1 million in professional fees.

Previous wording

During the three months ended June 30, 2025, our other income, net was approximately $0.015 million, which represented a decrease of approximately $0.078 million, or approximately 83.4%, compared to approximately $0.093 million for the three months ended June 30, 2024. The other income generated in the period consists primarily of income earned on our cash and cash equivalent accounts, the balances of which were lower during the three months ended June 30, 2025 compared to the three months ended June 30, 2024.

Current wording

During the three months ended September 30, 2025, our other income, net was approximately $0.04 million, which represented a decrease of approximately $0.03 million, or approximately 46.5%, compared to approximately $0.07 million for the three months ended September 30, 2024. The other income generated in the period consists primarily of income earned on our cash and cash equivalent accounts, the balances of which were lower during the three months ended September 30, 2025 compared to the three months ended September 30, 2024.

Previous wording

The following tables set forth our results of operations for the six months ended June 30, 2025 and 2024 and the relative dollar change between the two periods.

Current wording

The following tables set forth our results of operations for the nine months ended September 30, 2025 and 2024 and the relative dollar change between the two periods.

Previous wording

Research and development expenses were approximately $5.0 million for the six months ended June 30, 2025, compared to approximately $3.3 million for the six months ended June 30, 2024, representing an increase of approximately $1.7 million, or 50.6%. The increase was primarily driven by higher clinical trial costs of approximately $2.3 million related to our ongoing Phase 1 study. This increase was partially offset by a decrease of approximately $0.6 million in payroll and related expenses.

Current wording

Research and development expenses were approximately $6.5 million for the nine months ended September 30, 2025, compared to approximately $4.8 million for the nine months ended September 30, 2024, representing an increase of approximately $1.7 million, or 36.1%. The increase was primarily driven by higher clinical trial costs of approximately $2.6 million related to our ongoing Phase 1 study. This increase was partially offset by a decrease of approximately $0.9 million in payroll and related expenses and stock-based compensation.

Previous wording

General and administrative expenses were approximately $2.3 million for the three months ended June 30, 2025, compared to approximately $2.4 million for the three months ended June 30, 2024, representing a decrease of approximately $0.1 million, or 4.4%. The decrease was primarily attributable to a reduction of approximately $0.9 million in stock-based compensation, payroll and related expenses, legal fees, and investor relations costs. This decrease was partially offset by an increase of approximately $0.8 million in transaction-related expenses associated with the private placement of convertible notes and warrants completed in June 2025.

Current wording

General and administrative expenses were approximately $5.2 million for the nine months ended September 30, 2025, compared to approximately $6.4 million for the nine months ended September 30, 2024, representing a decrease of approximately $1.2 million, or 19.3%. The decrease was primarily attributable to a reduction of approximately $2.1 million in stock-based compensation, payroll and related expenses, board of directors fees, investor relations costs and directors and officers insurance policy. This decrease was partially offset by an increase of approximately $0.9 million in transaction-related expenses associated with the private placement of convertible notes and warrants completed in June 2025 and professional fees.

Previous wording

During the six months ended June 30, 2025, our other income, net was approximately $0.055 million, which represented a decrease of approximately $0.175 million, or approximately 75.8%, compared to approximately $0.230 million for the six months ended June 30, 2024. The other income generated in the period consists primarily of income earned on our cash and cash equivalent accounts, the balances of which were lower during the six months ended June 30, 2025 compared to the six months ended June 30, 2024.

Current wording

During the nine months ended September 30, 2025, our other income, net was approximately $0.1 million, which represented a decrease of approximately $0.2 million, or approximately 68.7%, compared to approximately $0.3 million for the nine months ended September 30, 2024. The other income generated in the period consists primarily of income earned on our cash and cash equivalent accounts, the balances of which were lower during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024.

Previous wording

In June 2025, we completed a private placement (the “June 2025 Financing”) of convertible notes to certain investors, including our Chief Executive Officer, which automatically converted in July 2025 into 501,566 shares of our common stock and pre-funded warrants to purchase 190,795 shares of our common stock at a conversion price of $8.302 per share. In connection with the offering, we also issued to the investors warrants to purchase 1,384,722 shares of our common stock, exercisable at $8.302 per share and expiring on July 27, 2030. The total gross proceeds were approximately $5.7 million and placement agent fees and other offering expenses were approximately $0.8 million.

Current wording

In June 2025, we completed a private placement (the “June 2025 Financing”) of convertible notes to certain investors, including our Chief Executive Officer, which automatically converted in July 2025 into 501,566 shares of our common stock and pre-funded warrants to purchase 190,795 shares of our common stock at a conversion price of $8.302 per share. In connection with the offering, we also issued to the investors warrants to purchase 1,384,722 shares of our common stock, exercisable at $8.302 per share and expiring on July 27, 2030. The total gross proceeds were approximately $5.7 million and placement agent fees and other offering expenses were approximately $0.8 million As of the date hereof, pre-funded warrants have been exercised into an aggregate of 124,634 shares of common stock.

Previous wording

In February 2025, we entered into a SEPA with Yorkville, pursuant to which we have the right, but not the obligation, to sell up to $20.0 million of our common stock during a 36 months period, subject to the restrictions and satisfaction of the conditions in the SEPA. Upon execution of the SEPA, we issued to Yorkville 10,927 commitment shares. During the first six months of 2025, we sold 89,902 shares of common stock under the SEPA for aggregate net proceeds of approximately $1.75 million, after deducting offering expenses in the amount of approximately $0.1 million.

Current wording

In February 2025, we entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN, LTD., a Cayman Islands exempt limited company (“Yorkville”), pursuant to which we have the right, but not the obligation, to sell up to $20.0 million of our common stock during a 36 months period, subject to the restrictions and satisfaction of the conditions in the SEPA. Upon execution of the SEPA, we issued to Yorkville 10,927 commitment shares. During the first nine months of 2025, we sold 89,902 shares of common stock under the SEPA for aggregate net proceeds of approximately $1.75 million, after deducting offering expenses in the amount of approximately $0.1 million.

Previous wording

In June 2022, we entered into an At The Market Offering Agreement (the “ATM Agreement”) which was amended on September 1, 2022 with H.C. Wainwright & Co., LLC, as sales agent (“Wainwright”), pursuant to which we may offer and sell, from time to time through Wainwright, shares of our common stock, par value $0.01 per share, for aggregate gross proceeds of up to $3.7 million. The issuance and sale of common stock by us under the ATM Agreement is being made pursuant to our effective “shelf” registration statement on Form S-3 filed with the SEC on September 1, 2022 and declared effective on September 9, 2022. In 2024, we sold 5,428 shares of our common stock for aggregate gross proceeds of approximately $0.4 million. On August 6, 2024, we filed a prospectus supplement to reduce the amount of shares registered under the prospectus for the ATM to $0.00 and to suspend the ATM program, but the ATM Agreement remains in full force and effect.

Current wording

In June 2022, we entered into an At The Market Offering Agreement (the “ATM Agreement”) which was amended on September 1, 2022 with H.C. Wainwright & Co., LLC, as sales agent (“Wainwright”), pursuant to which we may offer and sell, from time to time through Wainwright, shares of our common stock for aggregate gross proceeds of up to $3.7 million. The issuance and sale of common stock by us under the ATM Agreement is currently being made pursuant to our effective “shelf” registration statement on Form S-3 filed with the SEC on August 13, 2025 and declared effective on August 20, 2025. In 2024, we sold 5,428 shares of our common stock for aggregate gross proceeds of approximately $0.4 million. On September 2, 2025, we filed a prospectus supplement to increase the amount of shares registered under the prospectus for the ATM Agreement to $2.34 million. In September 2025, we sold 520,000 shares of our common stock for aggregate gross proceeds of approximately $2.34 million.

Previous wording

We believe that our cash and cash equivalents of approximately $6.2 million that we had as of June 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025 based on our current operating plan. We will need to increase our capital resources through equity or debt financings, and we may need to do so sooner than we expect. We may also seek to finance our cash needs through collaborations, strategic alliances, or license agreements with third parties. If sources of financing are available, they may result in substantial dilution to our stockholders. We cannot provide any assurance that new financing will be available to us on commercially acceptable terms or in the amounts required, if at all. If we are unable to consummate a financing or other transaction, we may need to delay, reduce, or eliminate our research and development programs, which could adversely affect our business prospects, or cease operations. These conditions raise substantial doubt regarding our ability to continue as a going concern within one year after the date of the filing of this Quarterly Report. For additional information, see Note 1 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.

Current wording

We believe that our cash and cash equivalents of approximately $5.8 million that we had as of September 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2026 based on our current operating plan. We will need to increase our capital resources through equity or debt financings, and we may need to do so sooner than we expect. We may also seek to finance our cash needs through collaborations, strategic alliances, or license agreements with third parties. If sources of financing are available, they may result in substantial dilution to our stockholders. We cannot provide any assurance that new financing will be available to us on commercially acceptable terms or in the amounts required, if at all. If we are unable to consummate a financing or other transaction, we may need to delay, reduce, or eliminate our research and development programs, which could adversely affect our business prospects, or cease operations. These conditions raise substantial doubt regarding our ability to continue as a going concern within one year after the date of the filing of this Quarterly Report. For additional information, see Note 1 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.

Previous wording

Net cash used in operating activities was approximately $9.1 million for the six months ended June 30, 2025, compared with net cash used in operating activities of approximately $6.4 million for the six months ended June 30, 2024. The increase in net cash used was primarily attributable to an increase in our research and development activities which were mostly related to our Phase 1 clinical trial and an increase in transaction-related expenses associated with the private placement of convertible notes and warrants completed in June 2025.

Current wording

Net cash used in operating activities was approximately $11.6 million for the nine months ended September 30, 2025, compared with net cash used in operating activities of approximately $8.9 million for the nine months ended September 30, 2024. The increase in net cash used was primarily attributable to an increase in our research and development activities which were mostly related to our Phase 1 clinical trial and an increase in transaction-related expenses associated with the private placement of convertible notes and warrants completed in June 2025.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2025 was approximately $9.4 million, which was provided by the issuance and sale of our common stock and warrants in the January 2025 Financing, the issuance and sale of our common stock under the SEPA and the issuance of convertible notes and warrants in the June 2025 Financing. Net cash provided by financing activities for the six months ended June 30, 2024 was approximately $0.4 million, which was provided by issuance and sale of our common stock under the ATM Agreement.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2025 was approximately $11.7 million, which was provided by the issuance and sale of our common stock and warrants in the January 2025 Financing, the issuance and sale of our common stock under the SEPA, the issuance of convertible notes and warrants in the June 2025 Financing andissuance and sale of our common stock under the ATM Agreement. Net cash provided by financing activities for the nine months ended September 30, 2024 was approximately $2.9 million, which was provided byissuance and sale of our common stock under the ATM Agreement and issuance and sale of our common stock and warrants in a registered direct offering and concurrent private placement that we completed in August 2024.

Previous wording

We believe that our existing cash and cash equivalents as of June 30, 2025 are adequate to fund our ongoing activities into the fourth quarter of 2025 based on our current operating plan. In addition, in May 2025, we began implementing a cost-reduction plan that included a focus on the Combination Study, the elimination of non-essential expenses, and accepted a voluntary temporary reduction of the base salaries of certain officers and temporary elimination of board fees.

Current wording

We believe that our existing cash and cash equivalents as of September 30, 2025 are adequate to fund our ongoing activities into the first quarter of 2026 based on our current operating plan. In addition, in May 2025, we began implementing a cost-reduction plan that included a focus on the Combination Study, the elimination of non-essential expenses, and accepted a voluntary temporary reduction of the base salaries of certain officers and temporary elimination of board fees. The temporary reduction of base salaries and board fees was discontinued effective November 1, 2025.

Previous wording

Operating lease liabilities represent our commitment for future rent made under a non-cancelable lease for our offices in San Diego, CA. The total future payments for our operating lease obligation on June 30, 2025 was approximately $0.03 million and are due in the next twelve months. For additional details regarding our lease, see Note 8 to our unaudited condensed consolidated financial statements included in this Quarterly Report.

Current wording

Operating lease liabilities represent our commitment for future rent made under a non-cancelable lease for our offices in San Diego, CA. As of September 30, 2025, the total remaining payments under this operating lease obligation were approximately $9,000. The lease expired on October 31, 2025. For additional details regarding our lease, see Note 8 to our unaudited condensed consolidated financial statements included in this Quarterly Report.

Previous wording

Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies” in our 2024 Annual Report on Form 10-K. During the six months ended June 30, 2025, there were no material changes to our critical accounting policies from those discussed in our 2024 Annual Report on Form 10-K.

Current wording

Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies” in our 2024 Annual Report on Form 10-K. During the nine months ended September 30, 2025, there were no material changes to our critical accounting policies from those discussed in our 2024 Annual Report on Form 10-K.