Immuneering Corp
For the period ended Dec 31, 2024. Filed Mar 20, 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 20, 2025
IMRX$3.68+9.2%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 2024-03-01.
0001790340-24-000024
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2024-12-31; filed 2025-03-20.
0001790340-25-000042
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 139 previous paragraphs and 136 current paragraphs.
102 unchanged; 24 reworded; 8 added; 12 removed; 1 previous and 2 current paragraphs rearranged.
Tables are not compared: 5 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 (8)
Current report
We are currently evaluating our lead product candidate, IMM-1-104, in a Phase 1/2a clinical trial in patients with advanced solid tumors including those harboring RAS or RAF mutations. IMM-1-104 is being developed as a once-daily oral deep cyclic inhibitor of the MAPK signaling pathway, specifically at the level of MEK. IMM-1-104 is designed to improve tolerability and expand indications beyond currently registered MEK inhibitors to include RAS-driven tumors such as most pancreatic cancers.
Current report
In January 2025, we announced positive interim response and safety data from three Phase 2a pancreatic cancer arms of the IMM-1-104 clinical trial, as well as our plans to initiate additional Phase 2a arms of IMM-1-104 in combination with a BRAF inhibitor for melanoma, in combination with a KRAS G12C inhibitor in non-small cell lung cancer, and in combination with checkpoint inhibitors for both melanoma and non-small cell lung cancer. Additional data from the Phase 2a portion of the trial is expected in the second quarter of 2025.
Current report
In January 2025, we announced initial interim PK, PD and safety data from the Phase 1 portion of the ongoing IMM-6-415 Phase 1/2a clinical trial. In February 2025, we paused further patient enrollment in the IMM-6-415 Phase 1/2a clinical trial in order to evaluate the data from patients being treated at the 120 mg dose level and determine next steps for the program.
Current report
During the twelve months ended December 31, 2024, we sold 1,318,752 shares of Class A common stock through our “at the market” equity offering program ("ATM Program"), at an average price per share of $3.27, for aggregate gross proceeds of $4.5 million ($4.2 million net of offering expenses). In January 2025, we sold an additional 4,836,804 shares of Class A common stock through our ATM Program, at an average price per share of $2.95, for aggregate gross proceeds of $14.2 million ($13.7 million net of offering expenses).
Current report
ATM Program. We did not sell any shares of Class A common stock under the ATM Program during the year ended December 31, 2023. We sold 1,318,752 shares of Class A common stock under the ATM Program, at an average price per share of $3.27, for aggregate gross proceeds of $4.5 million ($4.2 million net of offering expenses) during the year ended December 31, 2024. In January 2025, we sold an additional 4,836,804 shares of Class A common stock under the ATM Program, at an average price per share of $2.95, for aggregate gross proceeds of $14.2 million ($13.7 million net of offering expenses).
Current report
Going Concern Assessment
Current report
Based on our current operating plan, we believe that we do not have sufficient cash and cash equivalents on hand to support current operations for at least one year from the date of issuance of the financial statements appearing within this Annual Report on Form 10-K. To finance our operations beyond that point, we will need to raise additional capital. There can be no assurance that we will be able to obtain additional funding on acceptable terms, if at all. We have concluded that this circumstance raises substantial doubt about our ability to continue as a going concern for at least one year from the date of the issuance of our consolidated financial statements for the period ended December 31, 2024. We intend to obtain additional funding through available financing sources which may include additional public offerings of common stock, private financing of debt or equity, and / or the pursuit of strategic partnerships, licensing arrangements or collaborations to fund our future operations and remain as a going concern. To the extent that we raise additional capital through future equity offerings, the ownership interest of common stockholders will be diluted, which may be significant. See Note 1 - Organization and Nature of Business to our consolidated financial statements in this Annual Report on Form 10-K for additional information on our assessment. Until such time as we can generate revenue from product sales, if ever, we expect to finance our cash needs through a combination of equity offerings, debt financings, and potential collaborations, license and development agreements.
Current report
Based on our currently forecasted operating plan, we believe that our existing cash and cash equivalents as of December 31, 2024 and the $13.7 million net proceeds from the sale of Class A common stock through our ATM Program in January 2025 will enable us to fund our operating expenses and capital expenditure requirements into 2026. Therefore, based on our recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations, as of March 20, 2025, the issuance date of the consolidated financial statements for the year ended December 31, 2024 included elsewhere in this Annual Report on Form 10-K, management has concluded that there is substantial doubt about our ability to continue as a going concern for a period of one year from the issuance date of such consolidated financial statements. We are developing plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or debt financings, and/or potentially new collaborations, business transactions, and reducing cash expenditures. If we are not able to secure adequate additional funding, we plan to make significant reductions in spending. In that event, we may have to delay, scale back, or eliminate some or all of our operations, sell assets or seek other strategic solutions.
Removed paragraphs (12)
Previous report
Revenue
Previous report
Our revenue was historically generated by providing computational biology professional services to pharmaceutical and biotechnology companies. We charged an agreed upon rate per hour based on the aggregate level of personnel assigned to work on the project or a fixed fee for a defined scope of work. Our contracts specified the period of time over which these professional services would be provided. We recognized revenue over time by measuring the progress toward complete satisfaction of the performance obligation using a single method of measuring progress, which depicts the performance in transferring control of the associated services to the customer. We used input methods to measure the progress toward the complete satisfaction of performance obligations and evaluate the measure of progress each reporting period and, if necessary, adjusted the measure of performance and related revenue recognition. Any such adjustments were recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment.
Previous report
We ceased accepting new services contracts in order to focus on developing our wholly-owned internal pipeline. In September 2022, we completed our last remaining services contract associated with the computational biology professional services business.
Previous report
We also discontinued our biosample storage business, which was acquired through the BioArkive transaction, to external parties. In December 2022, we completed our last remaining storage contract. The revenue earned associated with the biosample storage business for the year ended December 31, 2022 is immaterial to the financial statements.
Previous report
At this time, we do not anticipate entering into any new service or storage contracts or agreements.
Previous report
Cost of Revenue
Previous report
Historically, our cost of revenue has primarily consisted of expenses related to providing professional services to our customers. These costs include salaries, bonuses, benefits, stock-based compensation expense, depreciation, facilities, and other outside services. As a result of the discontinued service contracts and bio-sample storage business, the cost of revenue incurred for the year ended December 31, 2022 is immaterial to the financial statements and not applicable for the year ended December 31, 2023.
Previous report
Revenue
Previous report
The following table summarizes the revenue recognized for the periods indicated:
Previous report
Revenue decreased by approximately $0.3 million, or 100.0%, to $0 for the year ended December 31, 2023 compared to approximately $0.3 million for the year ended December 31, 2022. The decrease in revenue was due to the wind down of our computational biology professional services and completion of existing customer services contracts during the year ended December 31, 2022.
Previous report
Cost of Revenue
Previous report
Cost of revenue decreased by approximately $0.2 million, or 100.0%, to $0 for the year ended December 31, 2023 compared to approximately $0.2 million for the year ended December 31, 2022. The decrease was primarily due to decreased employee-related costs related to services contracts that were discontinued as of September 2022.
Reworded paragraphs (24)
Previous wording
We are a clinical-stage oncology company seeking to develop universal-RAS/RAF medicines for broad populations of cancer patients. We aim to achieve universal RAS/RAF activity through deep cyclic inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells, Our inclusive approach differentiates us from narrowly targeted precision therapies, which are limited to patients with tumors harboring select mutations.
Current wording
We are a clinical-stage oncology company seeking to develop and commercialize more effectiveand better tolerated therapies for cancer patients. We aim to achieve this goal through deep cyclic inhibition of clinically-validated core signaling pathways such as the MAPK pathway, impacting cancer cells while sparing healthy cells. Our inclusive approach differentiates us from chronically targeted precision therapies, which aregenerally limited by toxicity, resistance and/or application to specific mutations only.
Previous wording
We are currently evaluating our lead product candidates, IMM-1-104 and IMM-6-415, in Phase 1/2a clinical trials in patients with advanced solid tumors harboring RAS and RAS/RAF mutations, respectively. IMM-1-104 is being developed as a once-daily oral therapy that aims to achieve universal-RAS activity through deep cyclic inhibition of the MAPK pathway. By contrast, IMM-6-415 aims to achieve universal-RAS/RAF activity with an accelerated twice-daily oral dosing cadence, also through deep cyclic inhibition of the MAPK pathway. Deep cyclic inhibition is a novel mechanism that aims to deprive tumor cells of the sustained proliferative signaling required for rapid growth, while sparing healthy cells through a cadenced, normalized level of signaling. This mechanism was engineered using our proprietary informatics-based discovery platform. The development of our pipeline is translationally guided by our proprietary, human-aligned 3D tumor modeling platform that we combine with bioinformatics-driven patient profiling, which we believe has the potential to increase the probability of success in clinical development versus traditional drug development approaches. Our pipeline also includes Trifecta MEK, RAS modulators and other small molecule drug discovery programs.
Current wording
Deep cyclic inhibition, or DCI, is a novel mechanism that aims to deprive tumor cells of the sustained proliferative signaling required for rapid growth, while sparing healthy cells through a cadenced, normalized level of signaling. This mechanism was engineered using our proprietary informatics-based discovery platform. The development of our pipeline is translationally guided by our proprietary, human-aligned 3D tumor modeling platform that we combine with bioinformatics-driven patient profiling, which we believe has the potential to increase the probability of success in clinical development versus traditional drug development approaches. Our pipeline also includes a discovery program targeting RAS, an undisclosed target, and other small molecule drug discovery programs.
Previous wording
In September 2022, the FDA cleared our IND application for IMM-1-104 and, in November 2022, we commenced dosing in our Phase 1/2a clinical trial of IMM-1-104 for the treatment of advanced RAS mutant solid tumors. The Phase 1/2a clinical trial is designed to assess the safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMM-1-104. The Phase 1 portion of the clinical trial includes dose escalation and dose exploration utilizing a Bayesian mTPI-2 statistical design to establish an optimized RP2D in solid tumor patients with evidence of any RAS mutation. The Phase 2a portion includes evaluating IMM-1-104 in multiple dose expansion arms at the candidate RP2D. In November 2023 we announced that we had expanded the IMM-1-104 Phase 1/2a clinical trial design by increasing the number of Phase 2a expansion arms to five, including two combination therapy arms and three monotherapy arms.
Current wording
In September 2022, the FDAcleared our IND application for IMM-1-104 and, in November 2022, we commenced dosing in our Phase 1/2a clinical trial of IMM-1-104 for the potential treatment of patients with advanced solid tumors including those harboring RAS mutations. The Phase 2a portion includes evaluating IMM-1-104 in multiple dose expansion and combination arms. We began dosing the Phase 2a cohorts in March 2024.
Previous wording
In December 2023, the FDA cleared our IND application for IMM-6-415 and we began the process of enrolling patients in a Phase 1/2a clinical trial of IMM-6-415 for the treatment of patients with advanced solid tumors harboring RAF or RAS mutations. The Phase 1/2a clinical trial is designed to assess the safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMM-6-415. The Phase 1 portion of the clinical trial includes dose escalation and dose exploration for IMM-6-415, using a mTPI-2 statistical design to establish an optimized RP2D in solid tumor patients with evidence of any RAF or RAS mutation. The Phase 2a portion includes exploring IMM-6-415 in multiple dose expansion arms at the candidate RP2D.
Current wording
In December 2023, the FDA cleared our IND application for IMM-6-415 and, in March 2024, we commenced dosing in our Phase 1/2a clinical trial of IMM-6-415 for the potential treatment of patients with advanced solid tumors harboring RAF or RAS mutations. The Phase 1/2a clinical trial is designed to assess the safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMM-6-415. The Phase 1 portion of the clinical trial includes dose escalation and dose exploration for IMM-6-415, using a mTPI-2 statistical design to establish an optimized RP2D in solid tumor patients with evidence of any RAF or RAS mutation. The Phase 2a portion includes evaluating IMM-6-415 in multiple dose expansion arms.
Previous wording
BioArkive is a San Diego based contract research organization that has previously provided preclinical research services and biosample storage to us and other biotechnology companies. BioArkive was fully integrated into our operations following the acquisition and exclusively supports our internal preclinical research activities for our oncology pipeline. In connection with the acquisition, we assumed the obligations under BioArkive’s three lease agreements.
Current wording
BioArkive was a San Diego based contract research organization that previously provided preclinical research services and biosample storage to us and other biotechnology companies. BioArkive was fully integrated into our operations following the acquisition and now exclusively supports our internal preclinical research activities for our oncology pipeline. In connection with the acquisition, we assumed the obligations under BioArkive’s three lease agreements.
Previous wording
Since our inception, we have had significant annual operating losses. Our net loss was approximately $53.5 million and $50.5 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, we had an accumulated deficit of approximately $163.3 million and approximately $85.7 million in cash, cash equivalents and marketable securities.
Current wording
Since our inception, we have had significant annual operating losses. Our net loss was approximately $61.0 million and $53.5 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of approximately $224.3 million and approximately $36.1 million in cash and cash equivalents.
Previous wording
Based on our current business plans, we believe that our existing cash, cash equivalents and marketable securities will enable us to fund our development activities and other operations into the second half of 2025. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.
Current wording
Based on our current business plans, we believe that our existing cash and cash equivalents as of December 31, 2024 and the $13.7 million net proceeds from the sale of Class A common stock through our ATM Program in January 2025 will enable us to fund our development activities and other operations into 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.
Previous wording
Research and development expenses increased by approximately $5.4 million, or 14.8%, to approximately $41.6 million for the year ended December 31, 2023 as compared to approximately $36.3 million for the year-ended December 31, 2022. The increase of approximately $5.4 million was primarily due to an increase of approximately $4.1 million related to direct research and development expenses, consisting of a $7.9 million increase related to the IMM-1-104 program and a $5.2 million increase related to IMM-6-415 program, offset by a $9.0 million decrease for expenses for earlier stage and neuroscience programs as compared to the same prior year period. The remaining increase was driven by unallocated research and development costs of approximately $1.3 million, consisting of a $1.0 million increase related to depreciation, facilities, and other allocated expenses in aggregate and a $0.7 million increase related to stock-based compensation expense, offset by a $0.4 million decrease in employee-related costs.
Current wording
Research and development expenses increased by approximately $6.3 million, or 15.2%, to approximately $48.0 million for the year ended December 31, 2024 as compared to approximately $41.6 million for the year-ended December 31, 2023. The increase of approximately $6.3 million was primarily due to an increase of approximately $6.8 million related to direct research and development expenses, consisting of a $8.8 million increase related to the IMM-1-104 program and a $1.4 million increase related to the IMM-6-415 program, offset by a $3.4 million decrease in expenses for earlier stage and neuroscience programs as compared to the same prior year period, and by a decrease in unallocated research and development costs of approximately $0.5 million, primarily driven by decreased employee-related costs of $0.7 million, offset by a $0.2 million increase related to stock compensation expense, depreciation, facilities, and other allocated expenses in aggregate.
Previous wording
General and administrative expenses increased by approximately $1.2 million, or 7.4%, to approximately $16.8 million for the year ended December 31, 2023 compared to approximately $15.6 million for the year ended December 31, 2022. The increase of approximately $1.2 million was primarily due to increased stock-based compensation of approximately $1.0 million, increased employee-related costs of $0.7 million, an increase of $0.5 million in other expenses, and increased professional fees incurred for accounting, auditing, legal, public relations and tax services of approximately $0.2 million, offset by decreased facilities and outside consulting expenses of approximately $1.2 million in the aggregate.
Current wording
General and administrative expenses decreased by approximately $0.7 million, or 4.1%, to approximately $16.1 million for the year ended December 31, 2024 compared to approximately $16.8 million for the year ended December 31, 2023. The decrease of approximately $0.7 million was primarily due to decreased employee-related costs of $0.5 million, decreased professional fees incurred for accounting, auditing, legal, public relations and tax services of approximately $0.7 million, and decreased facilities and other expenses of approximately $0.1 million in the aggregate; this decrease was offset by an increase in stock-based compensation of approximately $0.7 million.
Previous wording
Amortization of intangible asset of $29 thousand in the year ended December 31, 2023 and $30 thousand in the year ended December 31, 2022 is related to the technology acquired for the BioArkive acquisition completed in December 2021.
Current wording
Amortization of intangible asset was $29 thousand for the years ended December 31, 2024 and 2023. This is related to the technology acquired for the BioArkive acquisition completed in December 2021.
Previous wording
Interest income increased by approximately $2.6 million due to the interest earned on our cash, cash equivalents and marketable securities balances, due to the increase in interest rates during 2023 as compared to 2022.
Current wording
Interest income from the interest earned on our cash, cash equivalents and marketable securities balances decreased by approximately $1.0 million, driven by lower interest rates and a lower total cash balance, in the year ended December 31, 2024 as compared to the year ended December 31, 2023.
Previous wording
Other income, net was approximately $1.3 million in the year ended December 31, 2023, primarily driven by the accretion of discounts related to our marketable securities.
Current wording
Other income, net was approximately $0.4 million in the year ended December 31, 2024, compared to $1.3 million in the year ended December 31, 2023. This was primarily a result of the increase in the accretion of premiums related to our marketable securities.
Previous wording
We finance our operations through the issuance of convertible notes payable, convertible preferred stock, common stock, and the exercise of stock options. As of December 31, 2023, we had an accumulated deficit of $163.3 million and $85.7 million in cash, cash equivalents and marketable securities. Cash and cash equivalents are comprised of deposits at major financial banking institutions and highly liquid investments with an original maturity of three months or less at the date of purchase. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, reflected in the change in our outstanding accounts payable and accrued expenses.
Current wording
We finance our operations through the issuance of convertible notes payable, convertible preferred stock, common stock, and the exercise of stock options. As of December 31, 2024, we had an accumulated deficit of $224.3 million and $36.1 million in cash and cash equivalents. Cash and cash equivalents are comprised of deposits at major financial banking institutions and highly liquid investments with an original maturity of three months or less at the date of purchase. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, reflected in the change in our outstanding accounts payable and accrued expenses.
Previous wording
Since our inception, we have incurred significant operating losses. We have not yet commercialized any of our product candidates, and we do not expect to generate revenue from sales of any product candidates for the next several years, if at all. To date, our operations have been financed primarily by service revenues (which have ceased) and proceeds from sales of our debt and equity securities.
Current wording
Since our inception, we have incurred significant operating losses. Our net loss was approximately $61.0 million and $53.5 million for the years ended December 31, 2024 and 2023, respectively. We have not yet commercialized any of our product candidates, and we do not expect to generate revenue from sales of any product candidates for the next several years, if at all. To date, our operations have been financed primarily by service revenues (which have ceased) and proceeds from sales of our debt and equity securities.
Previous wording
On August 10, 2022, we entered into an Equity Distribution Agreement (the "Sales Agreement") with Piper Sandler & Co, to sell shares of our common stock with aggregate gross proceeds of up to $50 million, from time to time, through an “at the market” equity offering program ("ATM Program"). During the years ended December 31, 2023 and 2022, we did not sell any shares of common stock pursuant to the Sales Agreement under the ATM Program.
Current wording
On August 10, 2022, we entered into an Equity Distribution Agreement (the "Sales Agreement") with Piper Sandler & Co, to sell shares of our common stock with aggregate gross proceeds of up to $50 million, from time to time, through our
Previous wording
As of December 31, 2023, we have contractual obligations related to various leases of $0.7 million for 2024, $0.7 million for 2025, $0.8 million for 2026, $0.8 million for 2027, $0.8 million for 2028 and $2.9 million for the periods thereafter.
Current wording
As of December 31, 2024, we have contractual obligations related to various leases of $0.7 million for 2025, $0.8 million for 2026, $0.8 million for 2027, $0.8 million for 2028, $0.8 million for 2029 and $2.0 million for the periods thereafter.
Previous wording
During the year ended December 31, 2022, operating activities used approximately $44.1 million of cash, primarily resulting from our net loss of approximately $50.5 million and net amortization of premium (accretion of discount) on marketable securities of $0.2 million, partially offset by stock-based compensation expense of approximately $4.1 million, cash provided by changes in our operating assets and liabilities of approximately $1.7 million, and $0.8 million for right of use amortization and depreciation.
Current wording
During the year ended December 31, 2024, operating activities used approximately $55.0 million of cash, primarily resulting from our net loss of approximately $61.0 million, changes in our operating assets and liabilities of $0.9 million, and net amortization of premium (accretion of discount) on marketable securities of $0.3 million, partially offset by stock-based compensation expense of approximately $6.5 million and $0.7 million for the reduction in carrying amount of right-of-use assets and depreciation.
Previous wording
During the year end December 31, 2022, cash provided from investing was approximately $41.8 million, primarily related to maturities of marketable securities of $92.7 million, offset by purchases of marketable securities of $50.1 million and $0.7 million for purchases of property and equipment.
Current wording
During the year ended December 31, 2024, cash provided from investing activities was approximately $26.4 million, primarily related to maturities of marketable securities of $31.9 million, offset by purchases of marketable securities of $5.4 million and $0.1 million for purchases of property and equipment.
Previous wording
During the year ended December 31, 2023, cash provided from investing activities was approximately $7.3 million, primarily related to maturities of marketable securities of $52.3 million, offset by purchases of marketable securities of $44.7 million and $0.3 million for purchases of property and equipment.
Current wording
During the year end December 31, 2023, cash provided from investing activities was approximately $7.3 million, primarily related to maturities of marketable securities of $52.3 million, offset by purchases of marketable securities of $44.7 million and $0.3 million for purchases of property and equipment.
Previous wording
During the year ended December 31, 2022, net cash provided by financing activities was approximately $19 thousand, consisting primarily of approximately $0.3 million in net proceeds from the exercise of stock options, offset by approximately $0.3 million from the payment of deferred offering costs.
Current wording
During the year ended December 31, 2024, net cash provided by financing activities was approximately $5.3 million, primarily driven by proceeds of approximately $4.2 million from the issuance of Class A common stock under our ATM program, net of offering expenses, in addition to $0.7 million from the exercise of stock options and approximately $0.4 million from our employee stock purchase plan.
Previous wording
During the year ended December 31, 2023, net cash provided by financing activities was approximately $28.4 million, primarily driven by net proceeds, after deducting commissions and underwriting fees, of approximately $28.2 million from the Company's underwritten follow-on equity offering in April 2023, in addition to $0.4 million from the exercise of stock options, offset by $0.2 million in payments of costs related to the follow-on equity offering.
Current wording
During the year ended December 31, 2023, net cash provided by financing activities was approximately $28.4 million, primarily driven by net proceeds, after deducting commissions and underwriting fees, of approximately $28.2 million from our underwritten follow-on equity offering in April 2023, in addition to $0.4 million from the exercise of stock options, offset by $0.2 million in payments of costs related to the follow-on equity offering.
Previous wording
We incur substantial expenses associated with manufacturing and clinical trials. Accounting for clinical trials relating to activities performed by CROs and other external vendors requires management to exercise significant estimates in regard to the timing and accounting for these expenses. We estimate costs of research and development activities conducted by service providers, which include the conduct of sponsored research, preclinical studies and contract manufacturing activities. The diverse nature of services being provided under CROs and other arrangements, the different compensation arrangements that exist for each type of service and the lack of timely information related to certain clinical activities complicates the estimation of accruals for services rendered by CROs and other vendors in connection with clinical trials. Because payments of research and development activities do not always line up with the provision of such services, the balance sheet may reflect either an accrued or prepaid position. In estimating the duration of a clinical trial, we evaluate the start-up, treatment and wrap up periods, compensation arrangements and services rendered attributable to each clinical trial and fluctuations are regularly tested against payment plans and trial completion assumptions.
Current wording
We incur substantial expenses associated with manufacturing and clinical trials. Accounting for clinical trials relating to activities performed by CROs and other external vendors requires management to exercise significant estimates in regard to the timing and accounting for these expenses. We estimate costs of research and development activities conducted by service providers, which include the conduct of sponsored research, preclinical studies and contract manufacturing activities. The diverse nature of services being provided under CRO and other arrangements, the different compensation arrangements that exist for each type of service and the lack of timely information related to certain clinical activities complicates the estimation of accruals for services rendered by CROs and other vendors in connection with clinical trials. Because payments of research and development activities do not always line up with the provision of such services, the balance sheet may reflect either an accrued or prepaid position. In estimating the duration of a clinical trial, we evaluate the start-up, treatment and wrap up periods, compensation arrangements and services rendered attributable to each clinical trial and fluctuations are regularly tested against payment plans and trial completion assumptions.
Previous wording
A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our consolidated financial statements appearing at the end of this Annual Report on Form 10-K.
Current wording
A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our consolidated financial statements appearing in this Annual Report on Form 10-K.
Previous wording
We may remain classified as an EGC until December 31, 2026, which is the end of the fiscal year following the fifth anniversary of our IPO, although if the market value of our common stock that is held by non-affiliates exceeds $700 million as of June 30 of any year before that time, or if we have annual gross revenues of $1.235 billion or more in any fiscal year, we will cease to be an EGC as of December 31 of the applicable year. We also will cease to be an EGC if we issue more than $1.0 billion of non-convertible debt over a three-year period.
Current wording
We may qualify as an EGC until December 31, 2026, which is the end of the fiscal year following the fifth anniversary of our IPO, although if the market value of our common stock that is held by non-affiliates exceeds $700 million as of June 30 of any year before that time, or if we have annual gross revenues of $1.235 billion or more in any fiscal year, we will cease to be an EGC as of December 31 of the applicable year. We also will cease to be an EGC if we issue more than $1.0 billion of non-convertible debt over a three-year period.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Our second product candidate, IMM-6-415, aims to achieve broad activity with an accelerated twice-daily oral dosing cadence, also through deep cyclic inhibition of MEK.
Current report — wording carried from elsewhere
Based on our current business plans, we believe that our existing cash and cash equivalents as of December 31, 2024 and the $13.7 million net proceeds from the sale of Class A common stock through our ATM Program in January 2025 will enable us to fund our development activities and other operations into 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
We believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements for at least the next twelve months and into the second half of 2025. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.