Immuneering Corp
For the period ended Jun 30, 2024. Filed Aug 6, 2024.
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.
Jun 30, 2024 · Filed Aug 6, 2024
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-Q
Period ended 2024-03-31; filed 2024-05-07.
0001790340-24-000056
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-06.
0001790340-24-000066
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 137 previous paragraphs and 143 current paragraphs.
107 unchanged; 22 reworded; 8 added; 6 removed; 2 previous and 6 current paragraphs rearranged.
Tables are not compared: 4 previous and 7 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
In April 2024, we presented preclinical data at the American Association for Cancer Research ("AACR") annual meeting demonstrating that combining IMM-1-104 with chemotherapies used in the treatment of first-line pancreatic cancer yielded deeper and more durable tumor growth inhibition than either treatment alone. We view these data as supportive of the ongoing Phase 2a portion of our clinical trial of IMM-1-104 in RAS-mutant advanced or metastatic solid tumors.
Current report
Comparison of the Six Months Ended June 30, 2024 and 2023
Current report
The following table summarizes the components of research and development expenses for the periods indicated:
Current report
Research and development expenses increased by approximately $2.2 million, or 11.1%, to approximately $21.9 million for the six months ended June 30, 2024 as compared to approximately $19.7 million for the six months ended June 30, 2023. The increase of approximately $2.2 million was primarily due to an increase of approximately $2.4 million related to direct research and development expenses, of which there was a $4.4 million increase in expenses related to IMM-1-104, offset by a $0.7 million decrease in expenses related to IMM-6-415 driven by decreased manufacturing and preclinical spend, offset by increased clinical activity. Additionally, there was a $1.2 million decrease for earlier stage programs. The remaining offset was driven by decreased unallocated research and development costs of approximately $0.3 million, of which $0.3 million was associated with employee-related costs. The remaining decrease is attributable to a minor increase in stock-based compensation expense and depreciation/amortization costs, in the aggregate.
Current report
The following table summarizes the components of general and administrative expenses for the periods indicated:
Current report
General and administrative expenses decreased by approximately $0.1 million, or 1.6%, to approximately $8.4 million for the six months ended June 30, 2024 compared to approximately $8.5 million for the six months ended June 30, 2023. The decrease of approximately $0.1 million was primarily due to a decrease in professional fees incurred for accounting, auditing, legal and tax services of approximately $0.5 million, a decrease in employee-related costs of $0.2 million, and a decrease of $0.1 million for facilities and other allocated expense. This is offset by increased stock-based compensation expense of approximately $0.5 million, along with increased other expenses of $0.1 million.
Current report
Amortization of Intangible Asset
Current report
During the six months ended June 30, 2023, net cash provided by financing activities was approximately $28.4 million, primarily driven by net proceeds of approximately $28.2 million from the Company's underwritten follow-on equity offering, after deducting commissions and underwriting fees, in addition to $0.4 million from the exercise of stock options. This was partially offset by $0.2 million in payments of costs related to the public offering.
Removed paragraphs (6)
Previous report
Research and Development
Previous report
General and Administrative
Previous report
Other income (expense)
Previous report
Research and Development
Previous report
General and Administrative
Previous report
Other Income (Expense)
Reworded paragraphs (22)
Previous wording
In March 2024, we announced that the first patient was dosed in the Phase 2a portion of our Phase 1/2a clinical trial of IMM-1-104 in advanced RAS-mutant solid tumors. We anticipate enrolling approximately 150 patients in the Phase 2a portion of the clinical trial. The Phase 2a portion is expected to take place across up to 20 clinical sites in the United States. The patients will be administered our candidate RP2D of 320 mg once daily and will be separated into five arms as follows:
Current wording
In March 2024, we announced that the first patient was dosed in the Phase 2a portion of our Phase 1/2a clinical trial of IMM-1-104 in advanced RAS-mutant solid tumors. We anticipate enrolling approximately 150 patients in the Phase 2a portion of the clinical trial. The Phase 2a portion is expected to take place across up to 20 clinical sites in the United States. The patients will be administered our candidate RP2D of 320 mg once daily (and 240 mg once daily during the lead-in period for the combination arms) and will be separated into five arms as follows:
Previous wording
•IMM-1-104 in combination with modified FOLFIRINOX in patients with PDAC in the first-line setting (N≈30).
Current wording
•IMM-1-104 in combination with modified FOLFIRINOX in patients with PDAC in the first-line setting, which includes a lead-in period with dosing at 240 mg once daily (N≈30).
Previous wording
•IMM-1-104 in combination with modified gemcitabine plus nab-paclitaxel in patients with PDAC in the first-line setting (N≈30).
Current wording
•IMM-1-104 in combination with modified gemcitabine plus nab-paclitaxel in patients with PDAC in the first-line setting, which includes a lead-in period with dosing at 240mg once daily (N≈30).
Previous wording
We plan to announce initial data from multiple arms of the Phase 2a portion of the trial in 2024.
Current wording
We plan to announce initial data from multiple arms of the Phase 2a portion of the trial in the second half of 2024.
Previous wording
We plan to provide initial PK, PD and safety data from the Phase 1 portion of our Phase 1/2a clinical trial of IMM-6-415 in 2024.
Current wording
We plan to provide initial PK, PD and safety data from the Phase 1 portion of our Phase 1/2a clinical trial of IMM-6-415 in the second half of 2024.
Previous wording
On April 20, 2023, we completed an underwritten offering, pursuant to which we issued and sold 2,727,273 shares of our Class A common stock at an offering price of $11.00 per share. The aggregate net proceeds received from the offering was
Current wording
On April 20, 2023, we completed an underwritten offering, pursuant to which we issued and sold 2,727,273 shares of our Class A common stock at an offering price of $11.00 per share. The aggregate net proceeds received from the offering was $28.2 million, after deducting underwriting discounts and commissions, but before deducting offering costs payable by us, which were $0.2 million.
Previous wording
Since inception, we have had significant annual operating losses. Our net loss was approximately $14.3 million for the three months ended March 31, 2024 and approximately $53.5 million for the year ended December 31, 2023. As of March 31, 2024, we had an accumulated deficit of approximately $177.6 million and approximately $71.3 million in cash, cash equivalents and marketable securities.
Current wording
Since inception, we have had significant annual operating losses. Our net loss was approximately $28.4 million for the six months ended June 30, 2024 and approximately $53.5 million for the year ended December 31, 2023. As of June 30, 2024, we had an accumulated deficit of approximately $191.6 million and approximately $59.7 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.
Current wording
Based on our current business plans, we believe that our existing cash and cash equivalents 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.
Previous wording
We expect our general and administrative expenses may increase for the foreseeable future if and as we continue to increase our general and administrative headcount to support our continued research and development activities and, if any product candidates receive marketing approval, commercialization activities, as well as to support our operations generally. We also expect to continue to incur expenses associated with operating as a public company, including costs related to accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and rules and regulations of the Securities and Exchange Commission (“SEC”), Sarbanes-Oxley Act, director and officer insurance costs, and investor and public relations costs.
Current wording
We also expect to continue to incur expenses associated with operating as a public company, including costs related to accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and rules and regulations of the Securities and Exchange Commission (“SEC”), Sarbanes-Oxley Act, director and officer insurance costs, and investor and public relations costs.
Previous wording
Research and development expenses increased by approximately $1.0 million, or 9.7%, to approximately $11.2 million for the three months ended March 31, 2024 as compared to approximately $10.2 million for the three months ended March 31, 2023. The increase of approximately $1.0 million was primarily due to an increase of approximately $1.4 million related to direct research and development expenses, including a $1.6 million increase in expenses related to IMM-1-104 and an approximately $0.3 million increase in expenses related to IMM-6-415, offset by a decrease of approximately $0.5 million in expenses for earlier stage programs. The remaining variance was driven by a decrease in unallocated research and development expenses of approximately $0.4 million, which was primarily driven by the decrease of approximately $0.4 million in employee-related costs, offset by minor fluctuations related to stock-based compensation expense, depreciation/amortization, and facilities and other expenses, in the aggregate.
Current wording
Research and development expenses increased by approximately $1.2 million, or 12.7%, to approximately $10.7 million for the three months ended June 30, 2024 as compared to approximately $9.5 million for the three months ended June 30, 2023. The increase of approximately $1.2 million was primarily due to an increase of approximately $1.0 million related to direct research and development expenses, including a $2.8 million increase in expenses related to IMM-1-104, offset by an approximately $1.0 million decrease in expenses related to IMM-6-415 driven by decreased manufacturing and preclinical spend, offset by increased clinical spend. Additionally, there was a decrease of approximately $0.7 million in expenses for earlier stage programs. The remaining variance was driven by an increase in unallocated research and development expenses of approximately $0.2 million, which was primarily driven by increased employee-related costs of $0.1 million, in addition to increased stock-based compensation expense of $0.1 million.
Previous wording
General and administrative expenses decreased by approximately $0.3 million, or 7.7%, to approximately $4.1 million for the three months ended March 31, 2024 compared to approximately $4.5 million for the three months ended March 31, 2023. The decrease of approximately $0.3 million was primarily due to decreased professional fees for accounting, auditing and legal services of approximately $0.3 million, in addition to a decrease in employee-related costs of approximately $0.2 million, partially offset by increased stock-based compensation expense of approximately $0.2 million. The remaining variance is attributable to an approximate aggregate $0.1 million decrease in facilities and other expenses.
Current wording
General and administrative expenses increased by approximately $0.2 million, or 5.2%, to approximately $4.3 million for the three months ended June 30, 2024 compared to approximately $4.0 million for the three months ended June 30, 2023. The increase of approximately $0.2 million was primarily due to increased stock-based compensation expense of approximately $0.3 million and a $0.1 million increase in facilities and other expenses in the aggregate. This is primarily offset by decreased professional fees for accounting, auditing and legal services of approximately $0.2 million.
Previous wording
Interest income decreased by approximately $26 thousand for the three months ended March 31, 2024 as compared to the three months ended March 31, 2023. While the interest rates on our cash, cash equivalents and marketable securities balances increased, we had a lower total cash balance leading to an overall decrease in interest income.
Current wording
Interest income decreased by approximately $340 thousand for the three months ended June 30, 2024 as compared to the three months ended June 30, 2023. While the interest rates on our cash and cash equivalents balances increased, we had a lower total cash balance leading to an overall decrease in interest income.
Previous wording
Other income was approximately $0.2 million for the three months ended March 31, 2024, primarily as a result of the increase in the accretion of premiums related to our marketable securities.
Current wording
Other income was approximately $0.2 million for the six months ended June 30, 2024, compared to $0.4 million for the six months ended June 30, 2023. This is 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 March 31, 2024, we had an accumulated deficit of $177.6 million and $71.3 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 June 30, 2024, we had an accumulated deficit of $191.6 million and $59.7 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
On August 10, 2022, we entered into an Equity Distribution Agreement (the "Sales Agreement") with Piper Sandler & Co (the "Sales Agent"), 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 three months ended March 31, 2024, 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 (the "Sales Agent"), 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 six months ended June 30, 2024, we did not sell any shares of common stock pursuant to the Sales Agreement under the ATM Program.
Previous wording
As of March 31, 2024, we have contractual obligations related to various leases of $0.5 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 June 30, 2024, we have contractual obligations related to various leases of $0.4 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.
Previous wording
During the three months ended March 31, 2024, operating activities used approximately $15.5 million of cash, primarily resulting from our net loss of approximately $14.3 million and changes in assets and liabilities of $2.7 million, partially offset by stock-based compensation expense of approximately $1.5 million and the reduction in carrying amount of right-of-use assets of approximately $0.1 million.
Current wording
During the six months ended June 30, 2024, operating activities used approximately $27.0 million of cash, primarily resulting from our net loss of approximately $28.4 million and changes in assets and liabilities of $1.9 million, partially offset by stock-based compensation expense of approximately $3.1 million and the reduction in carrying amount of right-of-use assets of approximately $0.2 million.
Previous wording
During the three months ended March 31, 2023, operating activities used approximately $14.4 million of cash, primarily resulting from our net loss of approximately $13.6 million, partially offset by the reduction in carrying amount of right-of-use asset of approximately $0.1 million and stock-based compensation expense of approximately $1.3 million.
Current wording
During the six months ended June 30, 2023, operating activities used approximately $25.2 million of cash, primarily resulting from our net loss of approximately $25.8 million and changes in assets and liabilities of $2.0 million, partially offset by stock-based compensation expense of approximately $2.6 million and the reduction in carrying amount of right-of-use assets of $0.2 million.
Previous wording
During the three months ended March 31, 2024, investing activities provided approximately $21.4 million of cash, primarily resulting from the maturities of marketable securities of approximately $21.4 million, partially offset by purchases of property and equipment of approximately $37 thousand.
Current wording
During the six months ended June 30, 2024, investing activities provided approximately $26.4 million of cash, primarily resulting from the maturities of marketable securities of approximately $26.4 million, partially offset by purchases of property and equipment of approximately $70 thousand.
Previous wording
During the three months ended March 31, 2023, investing activities provided approximately $19.0 million, primarily resulting from the maturities of marketable securities of approximately $19.0 million, partially offset by purchases of property and equipment of approximately $27 thousand.
Current wording
During the six months ended June 30, 2023, investing activities provided approximately $28.1 million, primarily resulting from the maturities of marketable securities of approximately $28.3 million, partially offset by purchases of property and equipment of $0.1 million.
Previous wording
During the three months ended March 31, 2024, net cash provided by financing activities was approximately $1.0 million, primarily driven by proceeds of approximately $0.7 million from the exercise of stock options and approximately $0.2 million from the Company's employee stock purchase plan.
Current wording
During the six months ended June 30, 2024, net cash provided by financing activities was approximately $1.0 million, primarily driven by proceeds of approximately $0.7 million from the exercise of stock options and approximately $0.2 million from the Company's employee stock purchase plan.
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 utilize our available capital resources sooner than we expect.
Current wording
Based on our current business plans, we believe that our existing cash and cash equivalents 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 utilize our available capital resources sooner than we expect.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
In July 2024, we announced that the FDA granted Fast Track designation for IMM-1-104 as a first-line treatment for patients with PDAC.
Current report — wording carried from elsewhere
We expect our general and administrative expenses may increase for the foreseeable future if and as we continue to increase our general and administrative headcount to support our continued research and development activities and, if any product candidates receive marketing approval, commercialization activities, as well as to support our operations generally.
Current report — wording carried from elsewhere
Other income was approximately $8 thousand for the three months ended June 30, 2024, compared to $150 thousand for the three months ended June 30, 2023. This is primarily as a result of the increase in the accretion of premiums related to our marketable securities.
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the periods indicated:
Current report — wording carried from elsewhere
Amortization of intangible asset was $14,633 in the six months ended June 30, 2024, and 2023. This amortization is related to the technology acquired for the BioArkive acquisition completed in December 2021.
Current report — wording carried from elsewhere
Interest income decreased by approximately $0.4 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023. While the interest rates on our cash and cash equivalents balances increased, we had a lower total cash balance leading to an overall decrease in interest income.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
$28.2 million, after deducting underwriting discounts and commissions, but before deducting offering costs payable by us, which were $0.2 million.
Previous report — wording carried elsewhere
During the three months ended March 31, 2023, net cash provided by financing activities was approximately $0.2 million, consisting of approximately $0.2 million from the exercise of stock options.