Indaptus Therapeutics Inc
For the period ended Dec 31, 2024. Filed Mar 13, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 13, 2025
INDP$3.32+5.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-03-13.
0001493152-24-009769
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2024-12-31; filed 2025-03-13.
0001493152-25-010136
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 57 previous paragraphs and 59 current paragraphs.
40 unchanged; 13 reworded; 6 added; 4 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
Our research and development expenses for the year ended December 31, 2024 amounted to approximately $7.2 million, a decrease of approximately $0.4 million, or approximately 4.9%, compared with approximately $7.6 million for the year ended December 31, 2023. This decrease was attributable primarily to a decrease of approximately $1.3 million for the development of our manufacturing processes of Decoy20 that were mainly conducted in 2023 and was offset by an increase of approximately $0.9 million in costs associated with our Phase 1 clinical trial.
Current report
During the year ended December 31, 2024, our other income, net was approximately $0.3 million, which represented a decrease of approximately $0.6 million, or approximately 64.0%, as compared to the year ended December 31, 2023. The other income generated in the period consists primarily of income earned on the Company’s cash and cash equivalent accounts, the balances of which were lower during the year ended December 31, 2024 compared to the year ended December 31, 2023.
Current report
In January 2025, we completed a private placement for the sale and issuance by us of an aggregate of: (i) 2,109,383 shares of our common stock and (ii) warrants to purchase 2,109,383 shares of common stock. The shares and warrants were sold on a combined basis for consideration of $1.065 for one share and a warrant for aggregate gross proceeds of approximately $2.25 million.
Current report
In November 2024, we completed a registered direct offering, pursuant to which we sold and issued to certain investors 1,817,017 shares of our common stock in a registered direct offering. In addition, in a concurrent private placement, we issued to the investors unregistered warrants to purchase 1,817,017 shares of common. The combined purchase price for one share of common stock and one warrant was $1.175, resulting in gross proceeds of approximately $2.135 million.
Current report
In August 2024, we completed a registered direct offering, pursuant to which we sold and issued to certain investors, 1,643,837 shares of common stock. In addition, in a concurrent private placement, we issued to the investors unregistered warrants to purchase 1,643,837 shares of common stock. The combined purchase price for one share of common stock and one warrant was $1.825, resulting in gross proceeds of approximately $3.0 million.
Current report
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 month period, subject to the restrictions and satisfaction of the conditions in the SEPA. Upon execution of the SEPA, we issued to Yorkville 305,960 commitment shares. No shares of common stock have been sold under the SEPA.
Removed paragraphs (4)
Previous report
Our research and development expenses for the year ended December 31, 2023 amounted to approximately $7.6 million, an increase of approximately $1.3 million, or approximately 21%, compared with approximately $6.3 million for the year ended December 31, 2022. This increase was attributable primarily to (i) an increase of approximately $0.4 million for payroll and related expenses including approximately $0.1 million of stock-based compensation, and (ii) an increase of approximately $0.9 million for the Phase 1 clinical trial and activities related to the expansion of our pipeline.
Previous report
Our other income, net, for the year ended December 31, 2023 amounted to approximately $1.0 million, an increase of approximately $0.4 million, or approximately 62%, compared to approximately $0.6 million for the year ended December 31, 2022. This increase was attributable primarily to an increase of approximately $0.7 million in interest earned on deposits and interest earned on marketable securities, which was partially offset by a decrease of approximately $0.3 million from a gain that resulted from our settlement relating to a contractual dispute with Lohmann Therapie Systeme AG in February 2023.
Previous report
In December 2022, we entered into a purchase agreement and a registration rights agreement with Lincoln Park pursuant to which we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $20.0 million of our common stock (subject to certain limitations) from time to time over the term of the purchase agreement. We also filed a registration statement on Form S-1 to cover the resale of shares of our common stock issuable under the purchase agreement.
Previous report
Upon execution of the purchase agreement, we issued to Lincoln Park 142,450 initial commitment shares and are obligated to issue additional shares of common stock to Lincoln Park with a value of $125,000, calculated in accordance with the purchase agreement, on the date we have sold over $10.0 million in shares of common stock under the purchase agreement, up to a maximum of 76,220 shares of common stock (to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction), in each case as consideration for Lincoln Park’s irrevocable commitment to purchase shares of our common stock at our direction under the purchase agreement. Additionally, we have reserved up to 3,781,330 shares of our common stock for issuance and sale to Lincoln Park under the purchase agreement from time to time, if and when we determine to sell additional shares to Lincoln Park. No shares of common stock have been sold under the program.
Reworded paragraphs (13)
Previous wording
We are a clinical biotechnology company developing a novel and patented systemically-administered anti-cancer and anti-viral immunotherapy. We have evolved from more than a century of immunotherapy advances. Our approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system activating signals that can be administered safely intravenously. Our patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria, designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cellular components of innate and adaptive immunity. This approach has led to broad anti-tumor and anti-viral activity in preclinical models, including durable anti-tumor response synergy observed with each of five different classes of existing agents, including checkpoint therapy, targeted antibody therapy and low-dose chemotherapy. Tumor eradication by our technology has demonstrated activation of both innate and adaptive immunological memory and, importantly, did not require provision of or targeting a tumor antigen in preclinical models. In 2023, we initiated a Phase 1 clinical trial with our lead clinical candidate, Decoy20, in patients with advanced solid tumors where currently approved therapies have failed. For further information regarding our business and operations, see “Part I. Item 1. Business.”
Current wording
We are a clinical biotechnology company developing a novel and patented systemically-administered anti-cancer and anti-viral immunotherapy. We have evolved from more than a century of immunotherapy advances. Our approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system activating signals that can be administered safely intravenously. Our patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria, designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cellular components of innate and adaptive immunity. This approach has led to broad anti-tumor and anti-viral activity in preclinical models, including durable anti-tumor response synergy observed with each of four different classes of existing agents, including NSAIDs, checkpoint therapy, targeted antibody therapy and low-dose chemotherapy. Tumor eradication by our technology has demonstrated activation of both innate and adaptive immunological memory and, importantly, did not require provision of or targeting a tumor antigen in preclinical models. In 2023, we initiated a Phase 1 clinical trial with our lead clinical candidate, Decoy20, in patients with advanced solid tumors where currently approved therapies have failed. For further information regarding our business and operations, see “Part I. Item 1. Business.”
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 the 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. A resurgence of the COVID-19 pandemic or any new public health crisis could again affect our operations and those of third parties on which we rely, including by causing disruptions in the supply of our product candidates and the conduct of current and future clinical trials.
Current wording
Economic developments such as 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
General and administrative expenses include compensation, employee benefits, and stock-based compensation for executive management, finance administration and human resources, facility costs (including rent), professional service fees, and other general overhead costs, including depreciation, to support our operations.
Current wording
General and administrative expenses include compensation, employee benefits, and stock-based compensation, finance administration and human resources, facility costs (including rent), professional service fees, and other general overhead costs to support our operations.
Previous wording
We expect our general and administrative expenses to increase substantially for the foreseeable future as we continue to increase our headcount to support our research and development activities and operations generally, the growth of our business and, if any of our product candidates receive marketing approval, commercialization activities. We also expect to continue to incur additional expenses as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC, additional director and officer insurance expenses, investor relations activities, and other administrative and professional services.
Current wording
We expect our general and administrative expenses to increase for the foreseeable future as we continue to increase our headcount to support our research and development activities and operations generally, the growth of our business and, if any of our product candidates receive marketing approval, commercialization activities. We also expect to continue to incur additional expenses as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC, additional director and officer insurance expenses, investor relations activities, and other administrative and professional services.
Previous wording
Our general and administrative expenses for the year ended December 31, 2023 amounted to approximately $8.8 million, an increase of approximately $0.2 million, or approximately 2%, compared with approximately $8.6 million for the year ended December 31, 2022. This increase was attributable primarily to an increase of approximately $0.6 million for legal fees, recruitment costs, investor relations expenses and other professional fees, and was partially offset by a decrease of approximately $0.4 million for payroll and related expenses and for directors’ and officers’ insurance expenses.
Current wording
Our general and administrative expenses for the year ended December 31, 2024 amounted to approximately $8.1 million, a decrease of approximately $0.7 million, or approximately 7.3%, compared with approximately $8.8 million for the year ended December 31, 2023. This decrease was attributable primarily to a decrease of approximately $1.3 million in legal fees, recruitment costs, payroll and related expenses, franchise tax, and directors’ and officers’ insurance expenses, and was offset by an increase of approximately $0.6 million in investor relations and business development expenses.
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 March 2024, we sold 137,836 shares of our common stock for an 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 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 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 December 31, 2023, we had cash and cash equivalents of approximately $13.4 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 Annual Report. For additional information, see Note 1 to our consolidated financial statements included elsewhere in this Annual 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 $5.8 million that we had as of December 31, 2024 together with net proceeds of $2.0 million from our January 2025 financing, will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2025. 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 this prospectus. For additional information, see Note 1 to our consolidated financial statements included elsewhere in this Annual 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 $13.4 million for the year ended December 31, 2023, compared with net cash used in operating activities of approximately $13.1 million for the year ended December 31, 2022. The approximately $0.3 million increase in net cash used was primarily attributable to an increase in our spending related to research and development activities in connection with the Phase 1 clinical trial.
Current wording
Net cash used in operating activities was approximately $12.3 million for the year ended December 31, 2024, compared with net cash used in operating activities of approximately $13.4 million for the year ended December 31, 2023. The approximately $1.1 million decrease in net cash used was primarily attributable to changes in operating assets and liabilities.
Previous wording
Net cash provided by investing activities was approximately $17.1 million for the year ended December 31, 2023 which was related to the maturity of $24.0 million in marketable securities, offset by investment of approximately $6.9 million in marketable securities. Net cash used in investing activities was approximately $16.4 million for the year ended December 31, 2022, which was primarily related to approximately $29.6 million investment in marketable securities, offset by approximately $0.2 million from the proceeds received for assets held for sale and by $13.0 million from the maturity of marketable securities.
Current wording
There was no net cash provided by or used in investing activities for the year ended December 31, 2024. Net cash provided by investing activities was approximately $17.1 million for the year ended December 31, 2023, which was related to the maturity of $24.0 million in marketable securities, offset by net investment of approximately $6.9 million in marketable securities.
Previous wording
There was no net cash provided by or used in financing activities for the years ended December 31, 2023 and 2022.
Current wording
Net cash provided by financing activities for the year ended December 31, 2024 was approximately $4.8 million, which was provided by issuance and sale of our common stock under the ATM Agreement and issuance and sale of our common stock and warrants in the August 2024 Offering and in the November 2024 Offering. There was no net cash provided by or used in financing activities for the year ended December 31, 2023.
Previous wording
We believe that our existing cash and cash equivalents and marketable securities as of December 31, 2023 are adequate to fund our ongoing activities through the third quarter of 2024.
Current wording
We believe that our existing cash and cash equivalents and marketable securities as of December 31, 2024 are adequate to fund our ongoing activities into the second quarter of 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 December 31, 2023 were approximately $0.2 million, of which approximately $0.1 million is due in the next twelve months and the remaining payments are due over the following year. For additional details regarding our lease, see Note 8 to our consolidated financial statements included in this Annual 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. The total future payments for our operating lease obligation on December 31, 2024 were approximately $0.1 million and are due in the next twelve months. For additional details regarding our lease, see Note 7 to our consolidated financial statements included in this Annual Report.
Previous wording
We record the costs associated with services provided by CROs and CMOs as they are incurred. Though the scope and timing of work are generally based on signed agreements, some judgement is involved in determining periodic expenses because payment flows do not always match the periods over which services and materials are provided to us. As a result, our management is required to make estimates of services received and efforts expended pursuant to agreements established with these third-parties at each period-end date. During the year ended December 31, 2023, we incurred approximately $7.6 million of research and development expenses, of which approximately $3.9 million were for services provided by our CROs and CMOs. As of December 31, 2023, we recorded an accrued liability of approximately $0.4 million for expenses incurred, but not yet invoiced, and prepaid expenses and non-current other assets of approximately $0.8 million for payments made that relate to future periods. Overestimating or underestimating the services received or efforts expended could cause us to overstate or understate research and development expenses incurred within a reporting period, and related accrued and prepaid expenses.
Current wording
We record the costs associated with services provided by CROs and CMOs as they are incurred. Though the scope and timing of work are generally based on signed agreements, some judgement is involved in determining periodic expenses because payment flows do not always match the periods over which services and materials are provided to us. As a result, our management is required to make estimates of services received and efforts expended pursuant to agreements established with these third-parties at each period-end date. During the year ended December 31, 2024, we incurred approximately $7.2 million of research and development expenses, of which approximately $4.0 million were for services provided by our CROs and CMOs. As of December 31, 2024, we recorded an accrued liability of approximately $0.8 million for expenses incurred, but not yet invoiced, and prepaid expenses and non-current other assets of approximately $0.8 million for payments made that relate to future periods. Overestimating or underestimating the services received or efforts expended could cause us to overstate or understate research and development expenses incurred within a reporting period, and related accrued and prepaid expenses.