Immunome Inc
For the period ended Sep 30, 2024. Filed Nov 13, 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.
Sep 30, 2024 · Filed Nov 13, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-12.
0001558370-24-011898
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-13.
0001558370-24-015524
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 106 previous paragraphs and 106 current paragraphs.
77 unchanged; 23 reworded; 4 added; 4 removed; 2 previous and 2 current paragraphs rearranged.
Tables are not compared: 31 previous and 31 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 (4)
Current report
Our current programs
Current report
Research and development expenses increased by $33.4 million, from $3.8 million for the three months ended September 30, 2023 to $37.2 million for the three months ended September 30, 2024.
Current report
Comparison of the nine months ended September 30, 2024 and 2023
Current report
Research and development expenses increased by $68.2 million, from $13.5 million for the nine months ended September 30, 2023 to $81.7 million for the nine months ended September 30, 2024.
Removed paragraphs (4)
Previous report
Our current programs and strategic collaboration
Previous report
Research and development expenses increased by $23.4 million, from $5.7 million for the three months ended June 30, 2023 to $29.1 million for the three months ended June 30, 2024.
Previous report
Comparison of the six months ended June 30, 2024 and 2023
Previous report
Research and development expenses increased by $34.8 million, from $9.6 million for the six months ended June 30, 2023 to $44.5 million for the six months ended June 30, 2024.
Reworded paragraphs (23)
Previous wording
We are developing IM-1021, a preclinical stage ADC targeting ROR1 that we exclusively licensed from Zentalis Pharmaceuticals, Inc., or Zentalis, in January 2024.
Current wording
We are developing IM-1021, a preclinical stage ADC targeting ROR1 that we exclusively licensed from Zentalis Pharmaceuticals, Inc., or Zentalis, in January 2024, and acquired from Zentalis in October 2024 in connection with the Zentalis Asset Purchase.
Previous wording
In addition to the already described current programs, we expect to continue to invest in discovery efforts intended to expand our pipeline. Additional ADC programs are a major focus of these efforts, but other modalities, including RLTs, merit consideration. In the context of ADCs, we believe that quality antibodies against novel or underexplored targets, whether generated by our proprietary platform or acquired through business development, are the starting point for differentiated therapies. By pairing these antibodies with linkers and payloads that are suitable for the biology of each target, we believe we can ultimately develop therapies that bring substantial benefit to patients. We expect to add several such candidates to our pipeline in the future. We may also choose to acquire additional clinical-stage programs.
Current wording
In addition to the already described current programs, we expect to continue to invest in discovery efforts intended to expand our pipeline. Additional ADC programs are the primary focus of these efforts. We believe that quality antibodies against novel or underexplored targets, whether generated by our proprietary platform or acquired through business development, are the starting point for differentiated therapies. By pairing these antibodies with linkers and payloads that are suitable for the biology of each target, we believe we can ultimately develop therapies that bring substantial benefit to patients. We expect to add several such candidates to our pipeline in the future. We may also choose to acquire additional clinical-stage programs.
Previous wording
Additionally, we plan to expand our intellectual property estate and the infrastructure needed to discover and advance our platform and programs. We may continue to in-license or acquire complementary intellectual property as needed or required and we may continue to build our know-how and trade secrets. As an example, we may design and evaluate proprietary ADC components with the potential for use across multiple programs. We believe that establishing a broad toolbox of ADC-related technologies supports the development of first-in-class or best-in-class oncology therapies.
Current wording
Additionally, we plan to expand our intellectual property estate and the infrastructure needed to discover and advance our platform and programs. We may continue to in-license or acquire complementary intellectual property as needed or required and we may continue to build our know-how and trade secrets. As an example, we may design and evaluate proprietary ADC components with the potential for use across multiple programs. We believe that establishing a broad toolbox of ADC-related technologies supports the development of potential first-in-class or best-in-class oncology therapies.
Previous wording
In-process research and development expenses
Current wording
In-process research and development expense
Previous wording
Intangible assets acquired in an asset acquisition for use in research and development activities which have no alternative future use are expensed as in-process research and development, or IPR&D, expense on the acquisition date. IPR&D expenses for the six months ended June 30, 2024 primarily relate to the acquisition of our license pursuant to the Zentalis Agreement and the acquisition of certain assets from Ayala and Atreca.
Current wording
Intangible assets acquired in an asset acquisition for use in research and development activities which have no alternative future use are expensed as in-process research and development, or IPR&D, expense on the acquisition date. IPR&D expense for the nine months ended September 30, 2024 primarily relate to the acquisition of our license pursuant to the Zentalis License Agreement and the acquisition of certain assets from Ayala and Atreca.
Previous wording
Collaboration revenue decreased by $1.9 million, from $4.3 million for the three months ended June 30, 2023 to $2.4 million for the three months ended June 30, 2024. The decrease was primarily due to a decrease in certain research and development activities allocated to AbbVie during the three months ended June 30, 2024 compared to the same period in 2023.
Current wording
Collaboration revenue decreased by $0.7 million, from $3.6 million for the three months ended September 30, 2023 to $2.9 million for the three months ended September 30, 2024. The decrease was primarily due to a decrease in certain research and development activities allocated to AbbVie during the three months ended September 30, 2024 compared to the same period in 2023.
Previous wording
IPR&D expense for the six months ended June 30, 2024 primarily related to the write-off of IPR&D assets that were acquired from Zentalis, Ayala and Atreca and determined to have no alternative future use. There was no IPR&D expense for the six months ended June 30, 2023.
Current wording
IPR&D expense for the three months ended September 30, 2024 related to $4.0 million for the write-off of acquired IPR&D assets that were determined to have no alternative future use and $2.7 million for the issuance of unregistered shares of our common stockin connection with the BMS License Agreement Amendment. There was no IPR&D expense for the three months ended September 30, 2023.
Previous wording
General and administrative expenses increased by $2.7 million, from $4.3 million for the three months ended June 30, 2023 to $7.0 million for the three months ended June 30, 2024. The increase was primarily a result of a $2.6 million increase in personnel-related costs from an increase in headcount, including a $1.6 million increase in share-based compensation.
Current wording
General and administrative expenses increased by $5.2 million, from $4.4 million for the three months ended September 30, 2023 to $9.5 million for the three months ended September 30, 2024. The increase was primarily a result of a $4.1 million increase in personnel-related costs from an increase in headcount, including a $2.5 million increase in share-based compensation.
Previous wording
Interest income increased by $6.3 million from $0.4 million for the six months ended June 30, 2023 to $6.7 million for the six months ended June 30, 2024. The increase was primarily a result of increased interest rates and higher cash and cash equivalent and marketable security balances.
Current wording
Interest income increased by $3.1 million from $0.3 million for the three months ended September 30, 2023 to $3.4 million for the three months ended September 30, 2024. The increase was primarily a result of higher cash and cash equivalent and marketable security balances.
Previous wording
Collaboration revenue decreased by $3.2 million, from $6.6 million for the six months ended June 30, 2023 to $3.4 million for the six months ended June 30, 2024. The decrease was primarily due to a decrease in certain research and development activities allocated to AbbVie during the six months ended June 30, 2024 compared to the same period in 2023.
Current wording
Collaboration revenue decreased by $3.9 million, from $10.2 million for the nine months ended September 30, 2023 to $6.3 million for the nine months ended September 30, 2024. The decrease was primarily due to a decrease in certain research and development activities allocated to AbbVie during the nine months ended September 30, 2024 compared to the same period in 2023.
Previous wording
IPR&D expense for the three months ended June 30, 2024 primarily related to the write-off of IPR&D assets that were acquired from Atreca and determined to have no alternative future use. There was no IPR&D expense for the three months ended June 30, 2023.
Current wording
IPR&D expense for the nine months ended September 30, 2024 was primarily related to the write-off of acquired IPR&D assets that were determined to have no alternative future use. There was no IPR&D expense for the nine months ended September 30, 2023.
Previous wording
General and administrative expenses increased by $5.7 million, from $7.2 million for the six months ended June 30, 2023 to $13.0 million for the six months ended June 30, 2024. The increase was primarily a result of a $4.3 million increase in personnel-related costs from an increase in headcount, including a $2.6 million increase in share-based compensation. In addition, fees related to accounting, legal and patent fees and other overhead related costs increased by $1.4 million.
Current wording
General and administrative expenses increased by $10.9 million, from $11.6 million for the nine months ended September 30, 2023 to $22.5 million for the nine months ended September 30, 2024. The increase was primarily a result of a $8.4 million increase in personnel-related costs from an increase in headcount, including a $5.0 million increase in share-based compensation. In addition, fees related to accounting, legal and patent fees and other overhead related costs increased by $2.5 million.
Previous wording
Interest income increased by $3.7 million from $0.2 million for the three months ended June 30, 2023 to $3.9 million for the three months ended June 30, 2024. The increase was primarily a result of increased interest rates and higher cash and cash equivalent and marketable security balances.
Current wording
Interest income increased by $9.4 million from $0.7 million for the nine months ended September 30, 2023 to $10.1 million for the nine months ended September 30, 2024. The increase was primarily a result of increased interest rates and higher cash and cash equivalent and marketable security balances.
Previous wording
To date, we have not generated any revenue from commercial sale of products and do not expect to generate revenue from commercial sales for the foreseeable future. Since inception, we have incurred significant operating losses and negative cash flows from operations. Our net losses were $36.1 million and $5.6 million for the three months ended June 30, 2024 and 2023, respectively, and $165.6 million and $9.8 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had cash, cash equivalents and marketable securities of $278.4 million and an accumulated deficit of $388.4 million.
Current wording
To date, we have not generated any revenue from commercial sale of products and do not expect to generate revenue from commercial sales for the foreseeable future. Since inception, we have incurred significant operating losses and negative cash flows from operations. Our net losses were $47.1 million and $4.3 million for the three months ended September 30, 2024 and 2023, respectively, and $212.7 million and $14.2 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had cash, cash equivalents and marketable securities of $240.1 million and an accumulated deficit of $435.5 million.
Previous wording
The following table summarizes our sources and uses of cash for the six months ended June 30, 2024 and 2023 (in thousands):
Current wording
The following table summarizes our sources and uses of cash for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous wording
Net cash used in operating activities for the six months ended June 30, 2024 was $34.6 million, consisting primarily of our net loss of $165.6 million, partially offset by noncash charges of $123.7 million and a net change in operating assets and liabilities of $7.3 million. The noncash charges primarily consisted of $118.3 million of in-process research and development assets acquired without alternative future use and $5.4 million of share-based compensation. The change in operating assets and liabilities primarily consisted of an increase in accrued expenses and other current liabilities of $7.6 million, an increase in accounts payable of $2.4 million and a decrease in prepaid expenses and other assets of $0.9 million, partially offset by a decrease in deferred revenue of $3.4 million.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2024 was $68.7 million, consisting primarily of our net loss of $212.7 million, partially offset by noncash charges of $134.4 million and a net change in operating assets and liabilities of $9.6 million. The noncash charges primarily consisted of $125.0 million of in-process research and development assets acquired without alternative future use and $10.3 million of share-based compensation. The change in operating assets and liabilities primarily consisted of an increase in accrued expenses and other current liabilities of $13.5 million, an increase in accounts payable of $0.3 million and a decrease in prepaid expenses and other assets of $2.3 million, partially offset by a decrease in deferred revenue of $6.3 million.
Previous wording
Net cash provided by operating activities for the six months ended June 30, 2023 was $18.5 million, consisting primarily of our net loss of $9.8 million, partially offset by noncash charges of $2.6 million and a net change in operating assets and liabilities of $25.8 million. The noncash charges primarily consisted of $2.3 million of share-based compensation expense. The change in operating assets and liabilities primarily consisted of an increase in deferred revenue of $23.4 million, an increase in accounts payable of $1.3 million and a decrease in prepaid expenses and other assets of $1.2 million.
Current wording
Net cash provided by operating activities for the nine months ended September 30, 2023 was $9.9 million, consisting primarily of our net loss of $14.2 million, partially offset by noncash charges of $4.1 million and a net change in operating assets and liabilities of $19.9 million. The noncash charges primarily consisted of $3.3 million of share-based compensation expense. The change in operating assets and liabilities primarily consisted of an increase in deferred revenue of $19.8 million and a decrease in prepaid expenses and other assets of $1.6 million, partially offset by a decrease in accrued expenses and other current liabilities of $1.5 million.
Previous wording
Net cash used in investing activities for the six months ended June 30, 2024 was $118.9 million, consisting primarily of $112.7 million of purchases of marketable securities, $41.7 million of purchases of IPR&D assets and $4.5 million of purchases of property and equipment, partially offset by $40.0 million from maturities of marketable securities.
Current wording
Net cash used in investing activities for the nine months ended September 30, 2024 was $94.8 million, consisting primarily of $112.7 million of purchases of marketable securities, $46.1 million of purchases of IPR&D assets and $6.0 million of purchases of property and equipment, partially offset by $70.0 million from maturities of marketable securities.
Previous wording
Net cash used in investing activities for the six months ended June 30, 2023 was $0.4 million, consisting of purchases of property and equipment.
Current wording
Net cash used in investing activities for the nine months ended September 30, 2023 was $0.5 million, consisting of purchases of property and equipment.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2024 was $220.1 million, consisting of gross proceeds of $230.0 million from the 2024 Financing and $4.8 million from the exercise of options and common stock warrants, partially offset by offering costs of $14.6 million from our 2024 Financing and 2024 ATM Agreement.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was $220.4 million, consisting of gross proceeds of $230.0 million from the 2024 Financing and $5.3 million from the exercise of options and common stock warrants, partially offset by offering costs of $14.8 million from our 2024 Financing and 2024 ATM Agreement.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2023 was $34,000, consisting ofnet proceeds from the sales of common stock under our prior ATM sales agreement that we terminated in November 2023.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2023 was $60.9 million, consisting primarily of $61.0 million in gross proceeds from prepayments received in relation to the PIPE transaction associated with the closing of the Merger in October 2023. The Company received these funds prior to the closing of the Merger and recorded this transaction as a deposit liability in the accompanying condensed balance sheets as of September 30, 2023. Financing activities also provided $34,000 net proceeds from the sales of common stock under our prior ATM sales agreement that we terminated in November 2023, offset by $0.1 million in payments of deferred offering costs associated with the PIPE transaction.
Previous wording
While our significant accounting policies are described in Note 2 to our financial statements included elsewhere in this Quarterly Report on Form 10-Q, we believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operations.
Current wording
While our significant accounting policies are described in Note 2 to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q, we believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operations.
Previous wording
Research and development costs consist of costs incurred in performing research and development activities, including salaries and bonuses, share-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation and amortization, preclinical and clinical development expenses, including manufacture and testing of clinical supplies, and amounts incurred under license agreements, consulting agreements and other contracted services. Research and development costs are expensed as incurred.
Current wording
Research and development costs consist of costs incurred in performing research and development activities, including salaries and bonuses, share-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation and amortization, and preclinical and clinical development expenses, including process development, validation, and the manufacture of drug supplies, costs to conduct clinical trials, and amounts incurred under license agreements, consulting agreements and other contracted services. Research and development costs are expensed as incurred.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
In-process research and development expense
Current report — wording carried from elsewhere
In-process research and development expense
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
In-process research and development expenses
Previous report — wording carried elsewhere
In-process research and development expenses