Indaptus Therapeutics Inc

Previous wording

In May 2022, the U.S. Food and Drug Administration, or the FDA, allowed us to proceed under our IND for a Phase 1 clinical trial in patients with advanced solid tumors where currently approved therapies have failed, and in December 2022, we initiated this Phase 1 clinical trial which is an open label, multi-center, dose escalation and expansion, single arm (monotherapy) study conducted in 2 parts. The Phase 1 study has begun with a single dose escalation, which is planned to be followed by an expansion part with continuous weekly administration of Decoy20. The study is enrolling patients with advanced/metastatic solid tumors, who have exhausted approved treatment options. The study’s objectives are to assess the safety and tolerability of Decoy20, to determine the maximum tolerated dose and recommended Phase 2 dose, as well as to assess Decoy20 pharmacokinetics (PK), pharmacodynamics and clinical activity. The primary endpoints of the study are incidence, relatedness and severity of adverse events and treatment-emergent adverse events and determining the number of subjects per cohort with dose limiting toxicity-based adverse events. Secondary endpoints include the incidence of anti-drug antibodies and neutralizing antibodies pre- and post-treatment, change in Decoy20 PK parameters over time, objective response rate in subjects with measurable disease and duration of response.

Current wording

In May 2022, the U.S. Food and Drug Administration, or the FDA, allowed us to proceed under our IND for a Phase 1 clinical trial in patients with advanced solid tumors where currently approved therapies have failed. In December 2022, we initiated an open label, multi-center, dose escalation and expansion, single arm (monotherapy) Phase 1 study conducted in 2 parts. The Phase 1 study began with single dose administration and has now been followed with continuous weekly dosing of Decoy20 in tumor-specific expansion cohorts. The study is enrolling patients with any one of six advanced/metastatic solid tumors, who have exhausted approved treatment options. The study’s objectives are to assess the safety and tolerability of Decoy20, to determine the maximum tolerated dose, the optimal biologically active and recommended Phase 2 dose, as well as to assess Decoy20 pharmacokinetics (PK), pharmacodynamics and clinical activity. The primary endpoints of the study are incidence, relatedness and severity of adverse events and treatment-emergent adverse events and determining the number of subjects per cohort with dose limiting toxicity-based adverse events. Secondary endpoints include the incidence of anti-drug antibodies and neutralizing antibodies pre- and post-treatment, change in Decoy20 PK parameters over time, objective response rate and duration of response.

Previous wording

In August 2023, we completed the first cohort of patients who received a single dose in Part 1 of the Phase 1 clinical trial. Four patients were enrolled and evaluable in the first cohort. These patients experienced generally anticipated transient adverse events including hemodynamic changes such as changes in pulse or blood pressure that were resolved within 30 minutes and laboratory abnormalities such as grade 1-3 elevations in transaminases (liver function tests) and grade 4 reductions in lymphocytes that generally resolved within three days. One patient had a dose-limiting toxicity of grade 3 bradycardia (slow heart rate) and grade 2 hypotension (low blood pressure) which resolved within approximately 90 minutes with i.v. fluids. Patients also experienced transient induction of over 50 different biomarkers associated with innate and adaptive anti-tumor immune responses. After the end of infusion, Decoy20 was cleared from the blood within 30 to 120 minutes. Peak cytokine and chemokine induction occurred within ~4 to 24 hours and most subjects returned to baseline by 24-72 hours. This rapid clearance and associated transient cytokine/chemokine induction are desired to avoid prolonged toxicity, often associated with longer term cytokine exposure.

Current wording

In August 2023, we evaluated the first four patients who received a single dose of 7 x 10^7 Decoy20 in Part 1 of the Phase 1 clinical trial. All four patients who enrolled were evaluable in the first cohort. These patients experienced generally anticipated transient adverse events including hemodynamic changes such as changes in pulse or blood pressure that resolved within 30 minutes and laboratory abnormalities such as grade 1-3 elevations in transaminases (liver function tests) and grade 4 reductions in lymphocytes that generally resolved within three days. One patient had a dose-limiting toxicity of grade 3 bradycardia (slow heart rate) and grade 2 hypotension (low blood pressure) which resolved within approximately 90 minutes with i.v. fluids. Patients also experienced transient induction of over 50 different biomarkers associated with innate and adaptive anti-tumor immune responses. After the end of infusion, Decoy20 was cleared from the blood within 30 to 120 minutes. Peak cytokine and chemokine induction occurred within ~4 to 24 hours and most cytokine/chemokines returned to the patient’s respective baseline by 24-72 hours. This rapid clearance and associated transient cytokine/chemokine induction are desired to avoid prolonged toxicity, often associated with longer term cytokine exposure.

Previous wording

In September 2023, we advanced into the second cohort of the Phase 1 clinical trial after receiving authorization from the Safety Review Committee. In early March 2024, we completed the second cohort of patients who received a single dose in Part 1 of the Phase 1 clinical trial and, following authorization from the Safety Review Committee, advanced into the multi-dosing part of the Phase 1 clinical trial. The second cohort dose is a reduction from the dosing in the first cohort based on the significant pharmacodynamic effect seen with the first cohort and anticipated optimal Decoy20 safety profile for both multi-dosing and combination approaches.

Current wording

In September 2023, we began the second cohort of the Phase 1 clinical trial after receiving authorization from the Safety Review Committee. The second cohort dose was a reduction from 7 x 10^7 Decoy20 dose to 3 x 10^7 Decoy20 based on the significant pharmacodynamic effect seen with the first four patients in the first cohort. In March 2024, we completed the second cohort of patients who received a single dose of 3 x 10^7 Decoy20 in Part 1 of the clinical trial and, following authorization from the Safety Review Committee, advanced into the weekly dosing part of the trial. In May 2024, we dosed the first patient in the weekly dosing part and as of the date of the issuance of this Quarterly Report we completed one month of the weekly dosing part in the first three patients at the 3 x 10^7 Decoy20 dose.

Previous wording

Economic developments such as supply chain constraints and rising inflation and interest rates have negatively affected the global financial markets and may reduce our ability to access capital, which could negatively impact our short-term and long-term liquidity. The ultimate impact of current economic conditions is highly uncertain and subject to change. While it is unknown how long these conditions will last and what the complete financial effect will be to us, capital raise efforts and additional development of our technologies may be negatively affected. In addition, our business operations expose us to risks associated with public health crises and epidemics/pandemics, such as COVID-19.

Current wording

Economic developments such as supply chain constraints and rising inflation and interest rates have negatively affected the global financial markets and may reduce our ability to access capital, which could negatively impact our short-term and long-term liquidity. The ultimate impact of current economic conditions is highly uncertain and subject to change. While it is unknown how long these conditions will last and what the complete financial effect will be to us, capital raise efforts and additional development of our technologies may be negatively affected. In addition, our business operations expose us to risks associated with public health crises and epidemics/pandemics.

Previous wording

The following tables sets forth our results of operations for the three months ended March 31, 2024 and 2023 and the relative dollar change between the two periods.

Current wording

The following tables set forth our results of operations for the three months ended June 30, 2024 and 2023 and the relative dollar change between the two periods.

Previous wording

Our research and development expenses for the three months ended March 31, 2024 amounted to approximately $1.6 million, a decrease of approximately $0.3 million, or approximately 15%, compared to approximately $1.9 million for the three months ended March 31, 2023. This decrease was attributable primarily toour manufacturing processes of Decoy20 that were conducted in thethree months ended March 31, 2023. We expect our research and development expenses to increase for the remainder of the year as our Phase 1 clinical trial progresses.

Current wording

During the three months ended June 30, 2024, our research and development expenses were approximately $1.7 million, which represented an increase of approximately $0.2 million, or approximately 16%, compared to approximately $1.5 million for the three months ended June 30, 2023. This increase was attributable primarily to payroll and related expenses, including stock-based compensation. We expect our research and development expenses to increase for the remainder of the year as our Phase 1 clinical trial progresses.

Previous wording

During the three months ended March 31, 2024, our other income, net was approximately $0.1 million, which represented a decrease of approximately $0.1 million as compared to the three months ended March 31, 2023. The other income generated in the period consists primarily of income earned on the Company’s cash and cash equivalent accounts.

Current wording

During the three months ended June 30, 2024, our other income, net was approximately $0.1 million, which represented a decrease of approximately $0.16 million as compared to the three months ended June 30, 2023. The other income generated in the period consists primarily of income earned on the Company’s cash and cash equivalent accounts.

Previous wording

Ourgeneral and administrative expenses for the three months ended March 31, 2024 amounted to approximately $2.4 million, a decrease of approximately $0.2 million, or approximately 9%, compared to approximately $2.6 million for the three months ended March 31, 2023. This decrease was attributable primarily to a decrease of approximately $0.5 million in legal fees, recruitment costs and for directors’ and officers’ insurance expenses, and was offset by an increase of approximately $0.3 million in payroll and related expenses and investor relations expenses. We expect our general and administrative expenses to increase for the remainder of the year as we continue to support our research and development activities.

Current wording

During the six months ended June 30, 2024, our research and development expenses were approximately $3.3 million, which represented a decrease of approximately $0.1 million, or approximately 2%, compared to approximately $3.4 million for the six months ended June 30, 2023. This decrease was attributable primarily to a decrease of approximately $0.5 million in our manufacturing processes of Decoy20 that were conducted in 2023 and was offset by an increase of approximately $0.4 million in our Phase 1 clinical trial and in payroll and related expenses. We expect our research and development expenses to increase for the remainder of the year as our Phase 1 clinical trial progresses.

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 based on the prospectus supplement that was filed with the SEC on March 13, 2024, 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 $5.2 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 March 2024, we sold 137,836 shares of our common stock for aggregate gross proceeds of $0.3 million.

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 based on the prospectus supplement that was filed with the SEC on March 13, 2024, 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 $5.2 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 152,000 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.

Previous wording

As of March 31, 2024, we had cash and cash equivalents of approximately $9.7 million, which we believe will enable us to fund our operating expenses and capital expenditure requirements through the third quarter of 2024. While we intend to finance our cash needs principally through collaborations, strategic alliances, or license agreements with third parties and/or debt or equity financings, 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. 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 ourunaudited 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 the cash and cash equivalents of approximately $7.3 million that we had as of June 30, 2024, and the net proceeds of approximately $2.5 million received from the August 2024 Offering will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2025. While we intend to finance our cash needs principally through collaborations, strategic alliances, or license agreements with third parties and/or debt or equity financings, 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. 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 ourunaudited 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 $3.9 million for the three months ended March 31, 2024, compared with net cash used in operating activities of approximately $4.9 million for the three months ended March 31, 2023. The decrease in net cash used was primarily attributable to a decrease in our research and development activities, mostly related to our manufacturing processes of Decoy20, and a decrease in our general and administrative expenses. The decrease in net cash used was also attributable to the settlement fee that was paid in February 2023.

Current wording

Net cash used in operating activities was approximately $6.4 million for the six months ended June 30, 2024, compared with net cash used in operating activities of approximately $7.1 million for the six months ended June 30, 2023. The decrease in net cash used was primarily attributable to a settlement fee that was paid in February 2023.

Previous wording

There was no net cash provided by or used in investing activities in the three months ended March 31, 2024. Net cash provided by investing activities was approximately $2.1 million for the three months ended March 31, 2023, which was related to the maturity of $9.0 million in marketable securities, offset by net investment of approximately $6.9 million in marketable securities.

Current wording

There was no net cash provided by or used in investing activities in the six months ended June 30, 2024. Net cash provided by investing activities was approximately $10.1 million for the six months ended June 30, 2023, which was related to the maturity of $17.0 million in marketable securities, offset by net investment of approximately $6.9 million in marketable securities.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2024 was approximately $0.3 million, which was provided byissuance and sale of our common stock under the ATM Agreement. There was no net cash provided by or used in financing activities in the three months ended March 31, 2023.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2024 was approximately $0.4 million, which was provided byissuance and sale of our common stock under the ATM Agreement. There was no net cash provided by or used in financing activities in the six months ended June 30, 2023.

Previous wording

We believe that our existing cash and cash equivalents as of March 31, 2024 are adequate to fund our ongoing activities through the third quarter of 2024.

Current wording

We believe that our existing cash and cash equivalents as of the date of the issuance of this Quarterly Report are adequate to fund our ongoing activities into the first quarter of 2025.

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 2023 Annual Report on Form 10-K. During the three months ended March 31, 2024, there were no material changes to our critical accounting policies from those discussed in our 2023 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 2023 Annual Report on Form 10-K. During the six months ended June 30, 2024, there were no material changes to our critical accounting policies from those discussed in our 2023 Annual Report on Form 10-K.