INOVIO PHARMACEUTICALS, INC.
For the period ended Mar 31, 2025. Filed May 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 13, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-14.
0001055726-24-000052
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0001055726-25-000026
Item 2. 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 91 previous paragraphs and 76 current paragraphs.
30 unchanged; 35 reworded; 9 added; 22 removed; 4 previous and 2 current paragraphs rearranged.
Tables are not compared: 2 previous and 1 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 (9)
Current report
•$3.3 million in lower drug manufacturing andimmunology expenses related to INO-3107;
Current report
•$913,000 in lower contract labor;
Current report
•$714,000 of lower expensed inventory;
Current report
•$507,000 in lower employee and consultant stock-based compensation, as a result of the lower weighted average grant date fair value for the awards granted during 2025.
Current report
•$244,000 in higher clinical study expenses and outside services related to INO-3107.
Current report
•$745,000 in lower legal expenses due a decrease in litigation activity;
Current report
•$322,000 in lower rent expense.
Current report
Change in Fair Value of Common Stock Warrant Liability. The change in fair value of our common stock warrant liability change is related to the revaluation of the liability associated with the Warrants, as defined below, we issued in December 2024 and was primarily the result of a decrease in our stock price during the period. We record the fair value of these Warrants at each balance sheet date and will record gain or loss on the statement of operations for changes between balance sheet dates.
Current report
During the three months ended March 31, 2025, we sold 518,670 shares of common stock under the 2024
Removed paragraphs (22)
Previous report
In our completed Phase 1/2 clinical trial of INO-3107 for the treatment of HPV-6 and HPV-11-associated RRP, 81.3% (26/32) of patients experienced a reduction in the number of surgical interventions in the year following administration of INO-3107, when compared with the year prior to treatment. Of these 32 patients, nine did not require surgical intervention during or after the dosing window. Patients in the trial had a median range of 4 surgeries (2-8) in the year prior to dosing. There was a statistically significant median decrease of three surgical interventions when comparing the year following treatment to the year prior to treatment. Treatment with INO-3107 generated a strong immune response in the trial, inducing activated CD4 T cells and activated CD8 T cells with lytic potential. T-cell responses were also observed at Week 52, indicating a persistent cellular memory response. INO-3107 was well tolerated by participants in the trial, resulting in mostly low-grade (Grade 1) treatment-emergent adverse effects such as injection site pain and fatigue.
Previous report
Pharmaceuticals, Richter-Helm BioLogics, Thermo Fisher Scientific, the University of Pennsylvania, the Walter Reed Army Institute of Research, and The Wistar Institute.
Previous report
(b) Includes impairment of intangible assets of $2.0 million recorded in the second quarter of 2023.
Previous report
•$2.9 million in higher drug manufacturing related to INO-3107;
Previous report
•$1.7 million of higher expensed inventory.
Previous report
These increases were offset by:
Previous report
•$2.3 million in lower employee and consultant compensation, including stock-based compensation, due to lower headcount;
Previous report
•$829,000 in lower immunology and clinical study expenses related to INO-3107.
Previous report
•$9.4 million in lower employee and consultant compensation, including stock-based compensation, due to lower headcount;
Previous report
•$7.3 million in lower drug manufacturing and clinical study expenses related to INO-4800 after we discontinued this program in the fourth quarter of 2022;
Previous report
•$3.3 million in lower drug manufacturing and engineering services related to other COVID-19 studies that we ceased after we discontinued development of INO-4800;
Previous report
•$2.0 million related to the impairment charge on intangible assets in the second quarter of 2023 which did not recur during 2024;
Previous report
•$1.6 million in lower immunology and clinical study expenses related to INO-3107;
Previous report
•$1.3 million in lower clinical study expenses related to VGX-3100 as we discontinued development of this product candidate in the third quarter of 2023; and
Previous report
•$1.3 million in lower clinical study and subcontractor expenses related to our CEPI LASSA and MERS grants.
Previous report
•$11.0 million in higher drug manufacturing related to INO-3107;
Previous report
•$4.6 million of higher expensed inventory; and
Previous report
•$4.4 million of lower contra-research and development expense recorded from grant agreements.
Previous report
•$465,000 and $2.8 million, respectively, in legal expenses related to litigation matters settled in 2023 that did not recur in 2024.
Previous report
Impairment of goodwill. In September 2023, we concluded our goodwill was impaired due to a sustained decline in our stock price and related market capitalization, and a general decline in equity values in the biotechnology industry. Based on this analysis, we recognized a non-cash, pre-tax goodwill impairment charge of $10.5 million during the three months ended September 30, 2023.
Previous report
During the three months ended September 30, 2024, we sold 86,361 shares of common stock under the 2024
Previous report
During the three months ended March 31, 2023, we issued 760,083 shares of common stock pursuant to a securities class action settlement, as described in Note 11 to our condensed consolidated financial statements included in this report.
Reworded paragraphs (35)
Previous wording
Risk factors that could cause actual results to differ from those contained in the forward-looking statements include but are not limited to: our history of losses; our lack of products that have received regulatory approval; uncertainties inherent in clinical trials and product development programs, including but not limited to the fact that preclinical and clinical results may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve desired results, that preclinical studies and clinical trials may not commence, have sufficient enrollment or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies, that results from an animal study may not be indicative of results achievable in human studies, that clinical testing is expensive and can take many years to complete, that the outcome of any clinical trial is uncertain and failure can occur at any time during the clinical trial process, and that our proprietary smart device technology and DNA medicine candidates may fail to show the desired safety and efficacy traits in clinical trials; the availability of funding; the ability to manufacture our DNA medicine candidates; the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that we and our collaborators hope to develop; our ability to receive development, regulatory and commercialization event-based payments under our collaborative agreements; whether our proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; and the impact of government healthcare laws and proposals.
Current wording
Risk factors that could cause actual results to differ from those contained in the forward-looking statements include but are not limited to: our history of losses; our lack of products that have received regulatory approval; uncertainties inherent in clinical trials and product development programs, including but not limited to the fact that preclinical and clinical results may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve desired results, that preclinical studies and clinical trials may not commence, have sufficient enrollment or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies, that results from an animal study may not be indicative of results achievable in human studies, that clinical testing is expensive and can take many years to complete, that the outcome of any clinical trial is uncertain and failure can occur at any time during the clinical trial process, and that our proprietary device technology and DNA medicine candidates may fail to show the desired safety and efficacy traits in clinical trials; the availability of funding; the ability to manufacture our DNA medicine candidates; the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that we and our collaborators hope to develop; our ability to receive development, regulatory and commercialization event-based payments under our collaborative agreements; whether our proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; and the impact of government healthcare laws and proposals.
Previous wording
We are a clinical-stage biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from diseases associated with human papillomavirus (HPV), cancer, and infectious diseases. Our platform harnesses the power of in vivo protein production, featuring optimized design and delivery of DNA medicines that teach the body to manufacture its own disease-fighting tools.
Current wording
We are a clinical-stage biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases. Our platform harnesses the power of in vivo protein production, featuring optimized design and delivery of DNA medicines that teach the body to manufacture its own disease-fighting tools.
Previous wording
We use proprietary technology to design DNA plasmids which are small circular DNA molecules that work like software the body’s cells can download to produce specific proteins to target and fight disease. Our proprietary investigational CELLECTRA delivery devices are designed to optimally deliver the plasmids into the body's cells.
Current wording
We use proprietary technology to design DNA plasmids, which are small circular DNA molecules that work like software the body’s cells can download to produce specific proteins to target and fight disease. Our proprietary investigational CELLECTRA® devices are designed to deliver the plasmids into the body’s cells for optimal effect, without the use of chemical adjuvants, lipid nanoparticles or viral vectors.
Previous wording
Our lead candidate is INO-3107 for the treatment of recurrent respiratory papillomatosis, or RRP, a life-long, rare disease characterized by the growth of small tumors, or papillomas, in the respiratory tract primarily caused by HPV-6 and/or HPV-11 genotypes. Although mostly benign, these papillomas can cause severe, sometimes life-threatening airway obstruction and respiratory complications. The standard of care for RRP is surgery. The most widely cited U.S. epidemiology data, published in 1995, estimated that there were 14,000 active cases for both adults and juveniles, and about 1.8 new cases per 100,000 adults each year.
Current wording
Our lead candidate is INO-3107 for the treatment of recurrent respiratory papillomatosis, or RRP, a chronic, rare and debilitating disease characterized by the growth of small tumors, or papillomas, in the respiratory tract primarily caused by HPV-6 and/or HPV-11 genotypes. Although mostly benign, these papillomas can cause severe, sometimes life-threatening airway obstruction and respiratory complications. The standard of care for RRP is repeated invasive surgery.
Previous wording
In the fourth quarter of 2023, we received feedback from the U.S. Food and Drug Administration, or FDA, that the data from this completed trial could be used to support the submission of a Biologic License Application, or BLA, for review under the FDA’s accelerated approval program. As part of submitting our BLA under the accelerated program, we will need to satisfy all FDA filing requirements and initiate a confirmatory clinical trial prior to BLA submission. We previously expected to be able to submit our BLA by the end of 2024; however, during our device testing process we identified a manufacturing issue involving the single use disposable administration component of the CELLECTRA 5PSP device that we plan to use in the confirmatory trial. We are currently working to resolve the manufacturing issue, but we now expect that the timing for submission of the BLA will likely be delayed until mid-2025.
Current wording
In 2023, we received feedback from the U.S. Food and Drug Administration, or FDA, that the data from this completed trial could be used to support the submission of a Biologic License Application, or BLA, for review under the FDA’s accelerated approval program. As part of submitting our BLA under the accelerated program, we will need to satisfy all FDA filing requirements and initiate a confirmatory clinical trial prior to BLA submission. We previously expected to be able to submit our BLA by the end of 2024; however, during our device testing process we identified a manufacturing issue involving the single-use disposable administration component of the CELLECTRA 5PSP device that we plan to use in the confirmatory trial and that will be submitted for approval for commercial use. We resolved the manufacturing issue in the first quarter of 2025 and are currently on track to begin a rolling submission of the BLA in mid-2025 and to request priority review, with a goal of receiving file acceptance by the FDA by the end of 2025.
Previous wording
We are developing INO-3112, a DNA medicine candidate targeting HPV 16/18 combined with a DNA plasmid encoding for human IL-12 as an immune activator, for the treatment of oropharyngeal squamous cell carcinoma, or OPSCC, a type of head and neck cancer commonly known as throat cancer. The incidence of HPV-related throat cancer has increased rapidly in recent years in the United States, with an estimated 20,000 new cases each year. HPV-related throat cancer has surpassed cervical cancer as the most common HPV-related cancer. In the United States, men are four to five times more likely to be diagnosed with HPV-associated oropharyngeal cancers than women.
Current wording
We are developing INO-3112, a DNA medicine candidate targeting HPV 16/18 combined with a DNA plasmid encoding for human IL-12 as an immune activator, for the treatment of oropharyngeal squamous cell carcinoma, or OPSCC, a type of head and neck cancer commonly known as throat cancer. We have entered into a clinical collaboration and supply agreement with Coherus BioSciences, Inc. to evaluate the combination of INO-3112 and LOQTORZI (toripalimab-tpzi) in a clinical trial for patients with locoregionally advanced, high-risk, HPV16/18 positive OPSCC. Under the terms of the supply agreement, Coherus will provide LOQTORZI for a planned Phase 3 clinical trial. We have also gained alignment with FDA on the design of the planned Phase 3 trial in the United States and received initial feedback from European regulatory authorities on the proposed design of the trial in Europe.
Previous wording
We are developing INO-5401, an immunotherapy consisting of three DNA plasmids encoding for three tumor associated antigens, for the treatment of glioblastoma multiforme, or GBM, an aggressive type of brain cancer that accounts for more than 50% of all primary malignant brain tumors. GBM is one of the most complex, deadly, and treatment-resistant cancers. In the United States, nearly 15,000 people were expected to receive a GBM diagnosis in 2023, and it is estimated that more than 10,000 individuals will succumb to the disease each year.
Current wording
We are also developing INO-5401, an immunotherapy consisting of three DNA plasmids encoding for three tumor associated antigens, for the treatment of glioblastoma multiforme, or GBM, an aggressive type of brain cancer that accounts for more than 50% of all primary malignant brain tumors. GBM is one of the most complex, deadly, and treatment-resistant cancers.
Previous wording
Our partners and collaborators include Advaccine Biopharmaceuticals Suzhou Co, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation (Gates), Coalition for Epidemic Preparedness Innovations (CEPI), Coherus Biosciences, Defense Advanced Research Projects Agency (DARPA), The U.S. Department of Defense (DoD), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Kaneka Eurogentec, National Cancer Institute (NCI), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Plumbline Life Sciences, Regeneron
Current wording
Our partners and collaborators include Advaccine Biopharmaceuticals Suzhou Co, ApolloBio Corporation, AstraZeneca, Coherus Biosciences, Defense Advanced Research Projects Agency (DARPA), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Kaneka Eurogentec, National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Plumbline Life Sciences, Regeneron Pharmaceuticals, Richter BioLogics, the University of Pennsylvania and The Wistar Institute.
Previous wording
Revenue. Total revenue was $0 and $101,000 for the three and nine months ended September 30, 2024, respectively, as compared to $388,000 and $729,000 for the three and nine months ended September 30, 2023, respectively, all of which was derived under collaborative arrangements and other contracts.
Current wording
Revenue. Total revenue was $65,000 and $0 for the three months ended March 31, 2025 and 2024, respectively, all of which was derived under the collaborative arrangement with ApolloBio.
Previous wording
The following table summarizes our research and development expense by product candidate for the three and nine months ended September 30, 2024 and 2023:
Current wording
The following table summarizes our research and development expense by product candidate for the three months ended March 31, 2025 and 2024:
Previous wording
The increase in research and development expenses for the three-month period year over year was primarily the result of:
Current wording
The decrease in research and development expenses for the three-month period year over year was primarily the result of:
Previous wording
•$939,000 in lower drug manufacturing expenses for other programs; and
Current wording
•$639,000 in lower drug manufacturing expenses for other programs; and
Previous wording
•$2.2 million in higher engineering professional and outside services related to our device development; and
Current wording
•$926,000 in higher engineering professional and outside services related to our device development; and
Previous wording
Contributions received from current grant agreements and recorded as contra-research and development expense were $1.8 million and $1.9 million for the three and nine months ended September 30, 2024, respectively, as compared to $1.4 million and $6.4 million for the three and nine months ended September 30, 2023, respectively. The decrease for the nine- month period year over year was primarily due to decreases of $3.6 million and $403,000, respectively, in reimbursements from Advaccine and expenses earned under the sub-grants through Wistar, among other variances.
Current wording
Contributions received from current grant agreements and recorded as contra-research and development expense were $286,000 and $179,000 for the three months ended March 31, 2025 and 2024, respectively. The increase for the three-month period year over year was due to the increase in expenses earned under the sub-grants through Wistar, among other variances.
Previous wording
General and administrative expenses. General and administrative expenses, which include business development expenses and patent expenses, were $8.6 million and $29.4 million for the three and nine months ended September 30, 2024, respectively, as compared to $9.9 million and $37.3 million for the three and nine months ended September 30, 2023, respectively. Decreases for the three- and nine-month periods year over year included:
Current wording
General and administrative expenses. General and administrative expenses, which include business development expenses and patent expenses, were $9.0 million and $10.6 million for the three months ended March 31, 2025 and 2024, respectively. Decreases for the three-month period year over year included:
Previous wording
•$955,000 and $4.8 million, respectively, in employee compensation, including employee and consultant stock-based compensation, due to lower headcount and lower weighted average grant date fair value for the awards granted during 2024; and
Current wording
•$619,000 in lower employee and consultant stock-based compensation, as a result of the lower weighted average grant date fair value for the awards granted during 2025; and
Previous wording
Stock-based compensation. Stock-based compensation expense is measured at the grant date, based on the fair value of the award, and is recognized as expense over the requisite vesting period. Total employee and director stock-based compensation expense for the three and nine months ended September 30, 2024 was $1.2 million and $5.1 million, of which $581,000 and $2.2 million was included in research and development expenses and $619,000 and $2.9 million was included in general and administrative expenses, respectively. Total employee and director stock-based compensation expense for the three and nine months ended September 30, 2023 was $1.9 million and $8.3 million, respectively. Of these amounts, $846,000 and $3.5 million, respectively, was included in research and development expenses, and $1.1 million and $4.8 million, respectively, was included in general and administrative expenses. The decrease was due to a lower weighted average grant date fair value for the awards granted during 2024.
Current wording
Stock-based compensation. Employee stock-based compensation expense is measured at the grant date, based on the fair value of the award, and is recognized as expense over the requisite vesting period. Total employee and director stock-based compensation expense for the three months ended March 31, 2025 and 2024 was $1.4 million and $2.4 million, of which $547,000 and $1.0 million was included in research and development expenses and $821,000 and $1.4 million was included in general and administrative expenses, respectively. The decrease was due to a lower weighted average grant date fair value for the awards granted during 2025.
Previous wording
Interest income. Interest income for the three and nine months ended September 30, 2024 was $1.1 million and $3.9 million, respectively, as compared to $1.9 million and $6.3 million for the three and nine months ended September 30, 2023, respectively. The decrease for the three- and nine-month periods year over year was primarily due to a lower short-term investment balance.
Current wording
Interest income. Interest income for the three months ended March 31, 2025 and 2024 was $808,000 and $1.5 million, respectively. The decrease for the three-month period year over year was primarily due to a lower short-term investment balance.
Previous wording
Interest expense. Interest expense for the three and nine months ended September 30, 2024 was $0 and $178,000, respectively, as compared to $313,000 and $940,000 for the three and nine months ended September 30, 2023, respectively. The decrease was primarily due to lower interest expense on our senior convertible promissory notes that were repaid in full on March 1, 2024.
Current wording
Interest expense. Interest expense for the three months ended March 31, 2025 and 2024 was $0 and $178,000, respectively. The prior year interest expense related to our senior convertible promissory notes that were repaid in full on March 1, 2024.
Previous wording
Gain (loss) on investment in affiliated entity. The gain (loss) resulted from the change in the fair market value of our investment in PLS of $324,000 and $(136,000) for the three and nine months ended September 30, 2024, respectively, as compared to $214,000 and $988,000 for the three and nine months ended September 30, 2023, respectively. We record our investment in PLS at its market value based on the closing price of the shares on the Korea New Exchange Market at each balance sheet date, with changes in fair value reflected in the condensed consolidated statements of operations.
Current wording
Gain (loss) on investment in affiliated entity. The gain (loss) resulted from the change in the fair market value of our investment in PLS of $695,000 and $(126,000), respectively. We record our investment in PLS at its market value based on the closing price of the shares on the Korea New Exchange Market at each balance sheet date, with changes in fair value reflected in the condensed consolidated statements of operations.
Previous wording
Net unrealized gain (loss) on available-for-sale equity securities. The net unrealized gain (loss) on available-for-sale equity securities for the three and nine months ended September 30, 2024 of $1.3 million and $1.8 million, respectively, as compared to $(219,000) and $3.9 million for the three and nine months ended September 30, 2023, respectively, resulted from a change in the fair market value of the investments.
Current wording
Net unrealized gain on available-for-sale equity securities. The net unrealized gain on available-for-sale equity securities for the three months ended March 31, 2025 and 2024 of $140,000 and $501,000, respectively, resulted from a change in the fair market value of the investments.
Previous wording
Other (expense) income, net. Other (expense) income, net, for the three and nine months ended September 30, 2024 of $(580,000) and $(1.3) million, respectively, as compared to $3,000 and $(3.9) million for the three and nine months ended September 30, 2023, respectively, related primarily to the realized loss on short-term investments sold during the periods.
Current wording
Other expense, net. Other expense, net, for the three months ended March 31, 2025 and 2024 of $500 and $682,000, respectively, related primarily to the realized loss on short-term investments sold during the periods.
Previous wording
As of September 30, 2024, we had cash, cash equivalents and short-term investments of $84.8 million and working capital of $67.8 million, as compared to $145.3 million and $110.5 million, respectively, as of December 31, 2023.
Current wording
As of March 31, 2025, we had cash, cash equivalents and short-term investments of $68.4 million and working capital of $44.6 million, as compared to $94.1 million and $62.5 million, respectively, as of December 31, 2024.
Previous wording
Net cash used in operating activities was $84.4 million and $98.1 million for the nine months ended September 30, 2024 and 2023, respectively. The variance was primarily due to the timing and changes in working capital balances, offset by decreased operating expenses.
Current wording
Net cash used in operating activities was $26.9 million and $28.8 million for the three months ended March 31, 2025 and 2024, respectively. The variance was primarily due to the timing and changes in working capital balances, offset by decreased operating expenses.
Previous wording
Net cash provided by investing activities was $69.4 million and $67.4 million for the nine months ended September 30, 2024 and 2023, respectively. The variance was primarily the result of timing differences in short-term investment purchases, sales and maturities.
Current wording
Net cash (used in) provided by investing activities was $(52,000) and $45.4 million for the three months ended March 31, 2025 and 2024, respectively. The variance was primarily the result of timing differences in short-term investment purchases, sales and maturities.
Previous wording
Net cash provided by financing activities was $22.3 million and $3.2 million for the nine months ended September 30, 2024 and 2023, respectively. The variance was primarily due to the net proceeds from the April 2024 Offering (defined below) of $33.2 million and net proceeds of $5.9 million from the sale of common stock under the 2021 and 2024 Sales Agreements (defined below), offset by the repayment of our convertible senior notes of $16.4 million.
Current wording
Net cash provided by (used in) financing activities was $1.0 million and $(11.4) million for the three months ended March 31, 2025 and 2024, respectively. The variance was primarily due to the repayment of our convertible senior notes of $16.4 million in March 2024, offset by net proceeds of $5.2 million from the sale of common stock under the Sales Agreements (defined below) during the three months ended March 31, 2024, compared to $1.1 million received during the three months ended March 31, 2025.
Previous wording
On April 18, 2024, we closed an underwritten registered direct offering, or the Offering, relating to the issuance and sale of 2,536,258 shares at a price of $7.693 per share and pre-funded warrants to purchase up to 2,135,477 shares of common stock, or the Pre-Funded Warrants, at a price of $7.692 per Pre-Funded Warrant, which represents the per share price for the shares less the $0.001 per share exercise price for each Pre-Funded Warrant. The net proceeds from the Offering were $33.2 million, after deducting the underwriting discounts and commissions and offering expenses paid by us.
Current wording
On April 18, 2024, we closed an underwritten registered direct offering, or the April 2024 Offering, relating to the issuance and sale of 2,536,258 shares of common stock at a price of $7.693 per share and pre-funded warrants to purchase up to 2,135,477 shares of common stock, or the Pre-Funded Warrants, at a price of $7.692 per Pre-Funded Warrant, which represents the per share price for the shares less the $0.001 per share exercise price for each Pre-Funded Warrant. The net proceeds from the April 2024 Offering were $33.2 million, after deducting the underwriting discounts and commissions and offering expenses paid by us.
Previous wording
Sales Agreement. The sales were made at a weighted average price of $7.84 per share, resulting in aggregate net proceeds of
Current wording
Sales Agreement. The sales were made at a weighted average price of $2.16 per share, resulting in aggregate net proceeds of
Previous wording
$667,000. As of September 30, 2024, there was $59.3 million of remaining capacity under the 2024 Sales Agreement.
Current wording
$1.1 million. During the year ended December 31, 2024, we sold 133,900 shares of common stock under the 2024 Sales Agreement. The sales were made at a weighted average price of $7.02 per share, resulting in aggregate net proceeds of $925,000. As of March 31, 2025, there was $57.9 million of remaining capacity under the 2024 Sales Agreement.
Previous wording
During thethree months ended March 31, 2024, we sold 543,620 shares of our common stock under the 2021 Sales Agreement at a weighted average price of $9.76 per share, resulting in aggregate net proceeds of $5.2 million. During theyear ended December 31, 2023, we sold 875,305 shares of our common stock under the 2021 Sales Agreement at a weighted average price of $6.33 per share, resulting in aggregate net proceeds of $5.5 million. We terminated the 2021 Sales Agreement in August 2024 in connection with the entry into the 2024 Sales Agreement described above.
Current wording
During thethree months ended March 31, 2024, we sold 543,620 shares of our common stock under the 2021 Sales Agreement at a weighted average price of $9.76 per share, resulting in aggregate net proceeds of $5.2 million. We terminated the 2021 Sales Agreement in August 2024 in connection with the entry into the 2024 Sales Agreement described above.
Previous wording
During the nine months ended September 30, 2024, stock options to purchase 8,159 shares of common stock were exercised for aggregate net proceeds to us of $68,000, which proceeds were offset by tax payments made related to net share settlement of RSU awards of $421,000. During thenine months ended September 30, 2023, no stock options were exercised and tax payments of $467,000 were made related to net share settlement of RSU awards.
Current wording
During the three months ended March 31, 2025 and 2024, nostock options were exercised and tax payments of $74,000 and $174,000, respectively, were made related to net share settlement of RSU awards.
Previous wording
As of September 30, 2024, we had an accumulated deficit of $1.7 billion, and we expect to continue to operate at a loss for the near term. The amount of our accumulated deficit will continue to increase, as it will be expensive to continue research and development efforts. Our current cash resources will not be sufficient to complete the clinical development of our product candidates beyond INO-3107, and we anticipate that additional financing will be required in order to complete the development of and to commercialize and generate revenues from the sale of INO-3107 or any other product candidates that may receive regulatory approval. If these activities are successful and if we receive approval from the FDA to market our DNA medicine candidates, then we will need to raise additional funding to market and sell the approved products and equipment. In addition to the potential issuance of equity or debt securities in order to raise capital, we are also evaluating potential collaborations as an additional way to fund our operations. We expect our cash runway to extend into the third quarter of 2025, without giving effect to any further capital raising activities that we may undertake.
Current wording
As of March 31, 2025, we had an accumulated deficit of $1.7 billion, and we expect to continue to operate at a loss for the near term. The amount of our accumulated deficit will continue to increase, as it will be expensive to continue research and development efforts. Our current cash resources will not be sufficient to complete the clinical development of our product candidates beyond INO-3107, and we anticipate that additional financing will be required in order to complete the development of and to commercialize and generate revenues from the sale of INO-3107 or any other product candidates that may receive regulatory approval. If these activities are successful and if we receive approval from the FDA to market our DNA medicine candidates, then we will need to raise additional funding to market and sell the approved products and equipment. In addition to the potential issuance of equity or debt securities in order to raise capital, we are also evaluating potential collaborations as an additional way to fund our operations. We expect our cash runway to extend into the first quarter of 2026, without giving effect to any further capital raising activities that we may undertake.
Previous wording
Our ability to continue operations is dependent upon our ability to obtain additional capital in the future and achieve profitable operations. We expect to continue to rely on outside sources of financing to meet our capital needs and we may never achieve positive cash flow. In light of these factors, management believes that there is substantial doubt about our ability to continue as a going concern beyond the third quarter of 2025. The condensed consolidated financial statements as of and for the three and nine months ended September 30, 2024 do not include any adjustments that might result from the outcome of this uncertainty.
Current wording
Our ability to continue operations is dependent upon our ability to obtain additional capital in the future and achieve profitable operations. We expect to continue to rely on outside sources of financing to meet our capital needs and we may never achieve positive cash flow. In light of these factors, management believes that there is substantial doubt about our ability to continue as a going concern beyond the first quarter of 2026. The condensed consolidated financial statements as of and for the three months ended March 31, 2025 do not include any adjustments that might result from the outcome of this uncertainty.
Previous wording
We have existing supply agreements with contract manufacturers to manufacture drug substance. At September 30, 2024, we had approximately $2.0 million in minimum purchase obligations in connection with these agreements. We expect to satisfy these obligations from existing cash over the next twelve months.
Current wording
We have existing supply agreements with contract manufacturers to manufacture drug substance. At March 31, 2025, we had approximately $605,000 inminimum purchase obligations in connection with these agreements. We expect to satisfy these obligations from existing cash over the next twelve months.
Previous wording
During the nine months ended September 30, 2024, except for the repayment in full of our convertible senior notes as described above, there have been no other significant changes to our contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2023 Annual Report.
Current wording
During the three months ended March 31, 2025, there have been no significant changes to our contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2024 Annual Report.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Offering of Common Stock and Warrants
Current report — wording carried from elsewhere
On December 16, 2024, we closed an underwritten public offering, or the December 2024 Offering, relating to the issuance and sale of 10,000,000 shares of the common stock, and accompanying warrants to purchase 10,000,000 shares of common stock, or the Warrants, at an offering price of $3.00 per share and accompanying Warrant. The net proceeds from the December 2024 Offering were $27.6 million, after deducting the underwriting discounts and commissions and offering expenses paid by us.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
In January 2024, we announced a clinical collaboration and supply agreement with Coherus BioSciences, Inc. to evaluate the combination of INO-3112 and LOQTORZI (toripalimab-tpzi) in a clinical trial for patients with locoregionally advanced, high-risk, HPV16/18 positive OPSCC. Under the terms of the supply agreement, Coherus will provide LOQTORZI for a planned Phase 3 clinical trial. The manufacturing issue with the single use disposable administration component of the CELLECTRA 5PSP device that is impacting INO-3107 will also need be resolved before we can commence the Phase 3 trial with INO-3112.
Previous report — wording carried elsewhere
The decrease in research and development expenses for the nine-month period year over year was primarily the result of:
Previous report — wording carried elsewhere
•$5.6 million in lower drug manufacturing expenses for other programs;
Previous report — wording carried elsewhere
•$5.2 million in higher engineering professional and outside services related to our device development;