Immunome Reports First Quarter 2024 Financial Results and Provides Business Update
Immunome (Nasdaq: IMNM), a biotech company focused on targeted cancer therapies, reported its Q1 2024 financial results and provided a business update. The company has integrated AL102 and IM-1021 and is progressing towards regulatory submissions. Topline data for the Phase 3 RINGSIDE trial of AL102 is expected in H2 2025. IND submissions for IM-1021 and IM-3050 are anticipated in Q1 2025. Financially, Immunome has $309.7 million in cash and equivalents, with a runway extending into 2026. Q1 2024 expenses included $15.4 million in R&D, $112 million in in-process R&D from recent acquisitions, and $6 million in administrative costs. The company posted a net loss of $129.5 million, or $2.51 per share.
- Completed integration of AL102 and IM-1021.
- Topline data for Phase 3 RINGSIDE trial of AL102 expected in H2 2025.
- IND submissions for IM-1021 and IM-3050 expected in Q1 2025.
- Cash and equivalents total $309.7 million, extending runway into 2026.
- Reported net loss of $129.5 million for Q1 2024.
- In-process R&D expenses were $112 million related to recent acquisitions.
- General and administrative expenses were $6 million.
- R&D expenses were $15.4 million.
Insights
Immunome, Inc. has reported its first quarter financial results for 2024, which is of significant interest to retail investors. The company reported a net loss of $129.5 million for the quarter, equating to a loss of $2.51 per share. This figure includes in-process research and development expenses amounting to
Immunome’s strategic acquisitions and IND submissions are key developments. The integration of AL102 and IM-1021 suggest the company is on track with its planned regulatory submissions and clinical trials. The expectation for topline data from the Phase 3 RINGSIDE trial of AL102 by the second half of 2025 is particularly noteworthy. Success in this trial could be a pivotal moment for the company, potentially leading to significant advancements in the treatment of desmoid tumors. However, investors should be aware of the inherent risks associated with clinical trials, as any setbacks could impact the company’s valuation and prospects.
Immunome's work on next-generation ADC (Antibody-Drug Conjugate) technology is an exciting development within the biotech space. ADCs represent a promising area of targeted cancer therapy by combining the specificity of antibodies with the potency of chemotherapeutic agents. The mention of their internal and external efforts to expand the pipeline highlights a commitment to innovation. Investors should watch for updates on this front, as successful development and commercialization of such next-gen technologies could significantly enhance the company's growth trajectory and competitive position in the oncology sector.
- Integration of AL102 and IM-1021 completed
- Topline data for Phase 3 RINGSIDE trial of AL102 expected in second half of 2025
- IM-1021 and IM-3050 IND submissions expected in first quarter of 2025
“Immunome continues to build momentum. We have completed the integration of AL102 and are executing activities necessary for regulatory submissions,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer. “We have also completed the integration of IM-1021 and are advancing that program and IM-3050 towards clinical trials.”
Dr. Siegall continued, “In addition, we are working internally to design and develop additional next-generation ADC technology. Those efforts are complemented by our ongoing business development efforts, which seek to identify and procure high-quality technologies and clinical programs. Both our internal and external efforts are focused on expanding Immunome’s pipeline with additional programs that have first-in-class or best-in-class potential and can improve the lives of cancer patients.”
Pipeline Highlights
The purchase of AL101 and AL102 from Ayala Pharmaceuticals closed on March 25, 2024. Full enrollment for the Phase 3 RINGSIDE Part B study of AL102 for the treatment of desmoid tumors was completed in February 2024. Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome continues to perform additional manufacturing and pharmacology work required to support a new drug application filing for AL102.
Immunome anticipates submitting INDs for two preclinical candidates in the first quarter of 2025: IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted RLT.
First Quarter 2024 Financial Results
-
As of March 31, 2024, cash, cash equivalents and marketable securities totaled
$309.7 million -
Research and development expenses for the quarter ended March 31, 2024 were
$15.4 million $0.4 million -
In-process research and development expenses for the quarter ended March 31, 2024 were
$112.0 million -
General and administrative expenses for the quarter ended March 31, 2024 were
$6.0 million $1.8 million -
Immunome reported a net loss of
$129.5 million $2.51
About Immunome, Inc.
Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, and RLTs. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.
For more information, visit www.immunome.com or follow us on Twitter and LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). We use words such as “may,” “could,” “potential,” “will,” “plan,” “believe,” “expect,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. These forward-looking statements include, but are not limited to, Immunome’s expectation to report topline data for the ongoing Phase 3 RINGSIDE Part B trial of AL102 in the second half of 2025; Immunome’s expected timeline for submitting INDs for IM-3050 and IM-1021 in the first quarter of 2025; Immunome’s expected cash runway; Immunome’s ability to expand its pipeline through both internal and external efforts; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Such forward-looking statements are based on Immunome’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, the risk that Immunome will not be able to realize the benefits of its strategic transactions; Immunome’s ability to grow and successfully execute on its business plan, including the development and commercialization of its pipeline and integration of newly acquired assets; changes in the applicable laws or regulations; the possibility that Immunome may be adversely affected by other economic, business, and/or competitive factors; the risk that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that pre-clinical data may not be predictive of clinical data; the risk that interim results of a clinical trial do not necessarily predict final results; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; the risk that Immunome’s product and development candidates fail to achieve their intended endpoints; the complexity of numerous regulatory and legal requirements that Immunome needs to comply with to operate its business; the reliance on Immunome’s management; the prior experience and successes of the Immunome’s management team not being indicative of any future success; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; the failure to obtain, adequately protect, maintain or enforce Immunome’s intellectual property rights; and other risks and uncertainties indicated from time to time described in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 26, 2024, in ARS Pharma’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, being filed with the SEC today, and in Immunome’s other filings with the SEC. Immunome cautions that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements which speak only as of the date made. Moreover, Immunome operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Except as required by law, Immunome does not undertake any obligation to update publicly any forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in their expectations.
| Immunome, Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (Unaudited; In thousands) | ||||||||
| March 31, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 269,723 |
|
$ | 98,679 |
|
||
| Marketable securities | 39,983 |
|
39,463 |
|
||||
| Prepaid expenses and other current assets | 3,620 |
|
6,561 |
|
||||
| Total current assets | 313,326 |
|
144,703 |
|
||||
| Property and equipment, net | 4,302 |
|
2,073 |
|
||||
| Operating right-of-use assets | 1,458 |
|
1,564 |
|
||||
| Restricted cash | 100 |
|
100 |
|
||||
| Other long-term assets | 568 |
|
100 |
|
||||
| Total assets | $ | 319,754 |
|
$ | 148,540 |
|
||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 7,179 |
|
$ | 3,311 |
|
||
| Accrued expenses and other current liabilities | 10,844 |
|
8,025 |
|
||||
| Deferred revenue, current | 12,745 |
|
10,493 |
|
||||
| Total current liabilities | 30,768 |
|
21,829 |
|
||||
| Deferred revenue, non-current | 2,208 |
|
5,489 |
|
||||
| Operating lease liabilities, net of current portion | 1,206 |
|
1,340 |
|
||||
| Total liabilities | 34,182 |
|
28,658 |
|
||||
| Stockholders’ equity: | ||||||||
| Preferred stock | — |
|
— |
|
||||
| Common stock | 6 |
|
4 |
|
||||
| Additional paid-in capital | 637,861 |
|
342,663 |
|
||||
| Accumulated other comprehensive income | 4 |
|
22 |
|
||||
| Accumulated deficit | (352,299 |
) |
(222,807 |
) |
||||
| Total stockholders’ equity | 285,572 |
|
119,882 |
|
||||
| Total liabilities and stockholders’ equity | $ | 319,754 |
|
$ | 148,540 |
|
||
| Immunome, Inc. | ||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||
| (Unaudited; In thousands, except share and per share amounts) | ||||||||
| Three Months Ended March 31, | ||||||||
2024 |
2023 |
|||||||
| Collaboration revenue | $ | 1,029 |
|
$ | 2,364 |
|
||
| Operating expenses: | ||||||||
| In-process research and development | 111,954 |
|
— |
|
||||
| Research and development(1) | 15,369 |
|
3,913 |
|
||||
| General and administrative(1) | 6,005 |
|
2,922 |
|
||||
| Total operating expenses | 133,328 |
|
6,835 |
|
||||
| Loss from operations | (132,299 |
) |
(4,471 |
) |
||||
| Interest income | 2,807 |
|
201 |
|
||||
| Net loss | $ | (129,492 |
) |
$ | (4,270 |
) |
||
| Net loss per share, basic and diluted | $ | (2.51 |
) |
$ | (0.35 |
) |
||
| Weighted-average shares outstanding, basic and diluted | 51,544,383 |
|
12,182,478 |
|
||||
| Comprehensive loss | ||||||||
| Net loss | $ | (129,492 |
) |
$ | (4,270 |
) |
||
| Unrealized loss on marketable securities | (18 |
) |
— |
|
||||
| Comprehensive loss | $ | (129,510 |
) |
$ | (4,270 |
) |
||
| (1) Amounts include non-cash, stock-based compensation expense as follows (in thousands): | ||||||||
Three Months Ended March 31, |
||||||||
2024 |
2023 |
|||||||
| Research and development | $ | 383 |
$ | 430 |
||||
| General and administrative | 1,776 |
794 |
||||||
| Total share-based compensation expense | $ | 2,159 |
$ | 1,224 |
||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240514845046/en/
Investor Contact:
Max Rosett
Chief Financial Officer
investors@immunome.com
Source: Immunome, Inc.
FAQ
When will Immunome report topline data for the Phase 3 RINGSIDE trial of AL102?
What were Immunome's net loss and EPS for Q1 2024?
What is the cash runway for Immunome?
What are the anticipated IND submissions by Immunome in 2025?
How much did Immunome spend on in-process R&D in Q1 2024?
