Immunome Reports Full Year 2023 Financial Results and Provides Update on Recently Acquired Assets
- Immunome merged with Morphimmune and expanded its leadership team in 2023.
- The company acquired two promising assets and successfully completed a financing in early 2024.
- AL102 purchase closed in March 2024, with Phase 3 RINGSIDE trial data expected in Q1 2025.
- IM-1021 and IM-3050 IND filings anticipated in Q1 2025.
- Current cash runway expected to fund activities into 2026.
- Full-year 2023 financial results show cash, equivalents, and securities totaling $138.1 million.
- Net loss reported at $106.8 million for 2023.
- Research and development expenses were $23.1 million, with in-process R&D expenses at $80.8 million.
- General and administrative expenses amounted to $19.7 million.
- None.
Insights
The financial results of Immunome, Inc. reveal a substantial net loss of $106.8 million for the year ended December 31, 2023. This figure is critical when assessing the company's performance and potential for recovery. The reported loss per share of $5.38 is a direct measure of the company's profitability from a shareholder's perspective. It's important to note the capital raise through an underwritten offering of 11.5 million shares at $20 each, generating $230 million in gross proceeds. This capital injection is significant as it extends the company's cash runway into 2026, which could reassure investors about the company's short-term financial stability.
Another key financial aspect is the $80.8 million in-process R&D expense, indicating a heavy investment in the development of their pipeline. This is a double-edged sword; while it signifies potential growth and advancements, it also contributes to the current net loss. Investors should weigh the long-term potential of these investments against the immediate financial impact.
From a medical research perspective, the acquisition of AL102 and the exclusive licensing of IM-1021 indicate strategic moves by Immunome to strengthen its oncology pipeline. AL102's Phase 3 status and 'best-in-class' potential, along with IM-1021's 'first-in-class' potential as an ADC, are key factors that could drive the company's future growth. The industry places a high value on therapies that can be categorized as 'first' or 'best' in class due to their potential for market exclusivity and therapeutic impact.
The planned IND filings for IM-1021 and IM-3050 in the first quarter of 2025 suggest that the company is moving forward with its preclinical assets. However, it is imperative to consider the risks associated with clinical development, as the transition from preclinical to clinical stages is fraught with challenges and success is not guaranteed.
Immunome's strategic acquisitions and pipeline development are poised to potentially capture significant market share in the targeted cancer therapy space. The company's focus on ADCs and RLTs reflects current market trends favoring personalized and precision medicine. The successful financing round and cash runway projection illustrate investor confidence and provide the necessary resources for continued R&D, which is essential for maintaining competitiveness in the biotech sector.
However, the market's response to these developments will depend on the outcomes of the ongoing and future clinical trials. The anticipation of the Phase 3 RINGSIDE trial results for AL102 will likely be a focal point for investors, as Phase 3 data can be a major catalyst for stock price movement. Positive results could lead to significant value creation, while any setbacks might have a detrimental effect on investor sentiment and stock performance.
- Topline data for Phase 3 RINGSIDE trial of AL102 expected in first quarter of 2025
- IM-1021 and IM-3050 IND filings expected in first quarter of 2025
- Current cash expected to fund activities into 2026
“2023 was a transformative year for Immunome as we closed the merger with Morphimmune, advanced our pipeline and expanded the company’s leadership team,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer. “These accomplishments laid the groundwork for a productive start to 2024, including the acquisition of two promising assets and a successful financing.”
Dr. Siegall continued, “We are focused on efficiently developing our four existing assets and expanding our pipeline. We expect to add novel antibody-drug conjugates (ADCs) and radioligand therapies (RLTs) to the pipeline through internal discovery efforts while continuing to evaluate opportunities to acquire high-quality assets on favorable financial terms. We are well-positioned to develop best-in-class or first-in-class therapies to improve the lives of cancer patients.”
Pipeline Highlights
The purchase of AL102 from Ayala Pharmaceuticals closed on March 25, 2024. Immunome expects to report topline data for the ongoing Phase 3 RINGSIDE Part B trial of AL102 in the first quarter of 2025. Ayala previously announced the full enrollment of RINGSIDE in February 2024. In parallel, Immunome is evaluating and performing additional manufacturing and pharmacology work required to support an NDA submission of AL102.
Immunome’s preclinical pipeline includes IM-1021, a ROR1 ADC; IM-3050, a FAP-targeted RLT; and IM-4320, an anti-IL-38 immunotherapy candidate. Immunome anticipates submitting investigational new drug applications (INDs) for IM-3050 and IM-1021 in the first quarter of 2025. Anticipated timing for an IND for IM-4320 will be shared at a later date.
Highlights from 2023 and early 2024
-
Successfully completed an underwritten offering of 11.5M shares priced at
$20 $230.0M - Acquired AL102, a Phase 3 gamma secretase inhibitor with best-in-class potential, from Ayala Pharmaceuticals in March 2024.
- Exclusively licensed IM-1021 (formerly known as ZPC-21), a preclinical ROR1 ADC with first-in-class potential, as well as the underlying ADC linker-payload technology, from Zentalis in January 2024.
- Nominated IM-3050 as a FAP RLT candidate with first-in-class potential in December 2023.
-
Completed the acquisition of Morphimmune, Inc, a concurrent PIPE of
$125 million - Filled leadership positions post-merger, including key members of the Executive Committee and five VP/SVP roles.
Full-year 2023 Financial Results
-
As of December 31, 2023, cash, cash equivalents and marketable securities totaled
$138.1 million $230 million -
Research and development expenses for the year ended December 31, 2023 were
$23.1 million $80.8 million -
General and administrative expenses for the year ended December 31, 2023 were
$19.7 million -
Immunome reported a net loss of
$106.8 million $5.38
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, RLTs and immunotherapies. 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 and 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,” “goal,” “optimistic,” 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, statements regarding immunome’s expectation to add novel ADCs and RLTs to its pipeline; Immunome’s expectation to report topline data for the ongoing Phase 3 RINGSIDE Part B trial of AL102 in the first quarter of 2025; Immunome’s expected timeline for filing INDs for IM-3050 and IM-1021 in the first quarter of 2025; Immunome’s expectation that it will share a date for filing an IND for IM-4320; Immunome’s expectation that the funds from the February financing will support completion of the RINGSIDE trial and advancement of IM-1021, IM-3050 and IM-4320 into clinic; Immunome’s expected cash runway; 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; 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 our 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 exhibit 99.2 filed with Immunome’s Current Report on Form 8-K with Securities and Exchange Commission (“SEC”) on February 13, 2024, and in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2023, being filed with the SEC later 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. |
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Consolidated Balance Sheets |
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(in thousands, except share and per share amounts) |
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December 31, 2023 |
|
December 31, 2022 |
||||||
Assets |
|
|||||||
Current assets: |
|
|
|
|||||
Cash and cash equivalents |
$ |
98,679 |
|
$ |
20,323 |
|
||
Marketable securities |
39,463 |
|
— |
|
||||
Prepaid expenses and other current assets |
|
6,561 |
|
|
2,326 |
|
||
Total current assets |
|
144,703 |
|
|
22,649 |
|
||
Property and equipment, net |
|
2,073 |
|
|
681 |
|
||
Operating right-of-use asset, net |
1,564 |
|
284 |
|
||||
Restricted cash |
|
100 |
|
|
100 |
|
||
Deferred offering costs |
|
— |
|
|
332 |
|
||
Other long-term assets |
100 |
|
— |
|
||||
Total assets |
$ |
148,540 |
|
$ |
24,046 |
|
||
Liabilities and stockholders’ equity |
|
|
||||||
Current liabilities: |
|
|
||||||
Accounts payable |
$ |
3,311 |
|
$ |
2,400 |
|
||
Accrued expenses and other current liabilities |
|
8,025 |
|
|
4,931 |
|
||
Deferred revenue, current |
10,493 |
|
— |
|
||||
Total current liabilities |
|
21,829 |
|
|
7,331 |
|
||
Deferred revenue, non-current |
5,489 |
|
— |
|
||||
Other long-term liabilities |
|
1,340 |
|
|
62 |
|
||
Total liabilities |
|
28,658 |
|
|
7,393 |
|
||
Commitments and contingencies (Note 8) |
|
|
|
|
||||
Stockholders’ equity: |
|
|
||||||
Preferred stock |
— |
|
— |
|
||||
Common stock |
4 |
|
1 |
|
||||
Additional paid-in capital |
|
342,663 |
|
|
132,653 |
|
||
Accumulated other comprehensive income |
22 |
|
— |
|
||||
Accumulated deficit |
|
(222,807 |
) |
|
(116,001 |
) |
||
Total stockholders’ equity |
|
119,882 |
|
|
16,653 |
|
||
Total liabilities and stockholders’ equity |
$ |
148,540 |
|
$ |
24,046 |
|
||
Immunome, Inc. |
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Consolidated Statements of Operations |
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(in thousands, except share and per share amounts) |
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Year Ended December 31, |
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|
2023 |
|
2022 |
|||||
Collaboration revenue |
$ |
14,018 |
|
$ |
— |
|
||
Operating expenses: |
|
|
|
|
||||
In-process research and development |
80,802 |
|
— |
|
||||
Research and development |
23,089 |
|
23,272 |
|
||||
General and administrative |
|
19,657 |
|
|
13,629 |
|
||
Total operating expenses |
|
123,548 |
|
|
36,901 |
|
||
Loss from operations |
|
(109,530 |
) |
|
(36,901 |
) |
||
Other income: |
||||||||
Interest income, net |
|
2,724 |
|
|
5 |
|
||
Total other income |
2,724 |
|
5 |
|
||||
Net loss |
$ |
(106,806 |
) |
$ |
(36,896 |
) |
||
Deemed dividend arising from warrant modification |
— |
|
(622 |
) |
||||
Net loss attributable to common stockholders |
$ |
(106,806 |
) |
$ |
(37,518 |
) |
||
Per share information: |
|
|
||||||
Net loss per common share, basic and diluted |
$ |
(5.38 |
) |
$ |
(3.09 |
) |
||
Weighted-average common shares outstanding, basic and diluted |
|
19,843,651 |
|
|
12,126,573 |
|
||
Comprehensive loss |
||||||||
Net loss |
$ |
(106,806 |
) |
$ |
(37,518 |
) |
||
Unrealized gain on marketable securities |
22 |
|
— |
|
||||
Comprehensive loss |
$ |
(106,784 |
) |
$ |
(37,518 |
) |
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240328336295/en/
Investor Contact:
Max Rosett
Interim Chief Financial Officer
investors@immunome.com
Source: Immunome, Inc.
FAQ
When is the topline data for the Phase 3 RINGSIDE trial of AL102 expected?
What are the anticipated IND filing timelines for IM-1021 and IM-3050?
How long is the current cash runway expected to fund activities?
What were the full-year 2023 financial results for Immunome, Inc.?
What were the research and development expenses for Immunome in 2023?
