Immunome(US:IMNM)2024-05-14 12:05PART I – FINANCIAL INFORMATION Financial Statements (Unaudited) The unaudited statements show a significant net loss driven by IPR&D expenses and a cash increase from a public offering Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | March 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $269,723 | $98,679 | | Total Assets | $319,754 | $148,540 | | Total Liabilities | $34,182 | $28,658 | | Total Stockholders' Equity | $285,572 | $119,882 | Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Collaboration Revenue | $1,029 | $2,364 | | In-process research and development | $111,954 | $0 | | Research and development | $15,369 | $3,913 | | Net Loss | $(129,492) | $(4,270) | | Net Loss per Share | $(2.51) | $(0.35) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(11,170) | $24,173 | | Net cash used in investing activities | $(37,231) | $(106) | | Net cash provided by financing activities | $219,445 | $34 | - The company completed a follow-on public offering in February 2024, issuing 11,500,000 shares for net proceeds of $215.4 million85 - In-process research and development (IPR&D) expenses of $112.0 million were recognized in Q1 2024, related to asset acquisitions from Ayala Pharmaceuticals and Zentalis Pharmaceuticals5869120 Management's Discussion and Analysis of Financial Condition and Results of Operations The analysis details a higher net loss from IPR&D expenses and improved liquidity from a recent public offering Overview and Pipeline The company's oncology pipeline includes clinical asset AL102 and three preclinical assets targeting IND submissions in Q1 2025 - The company's pipeline consists of one clinical asset, AL102, and three preclinical assets: IM-1021, IM-3050, and IM-4320101 - AL102, an investigational GSI for desmoid tumors, is in a Phase 3 trial, with topline data expected in H2 2025103105107 - The company plans to submit Investigational New Drug (IND) applications for IM-1021 and IM-3050 in Q1 2025110113 Results of Operations Operating expenses surged due to a $112.0 million IPR&D expense, while R&D and G&A costs also increased Comparison of Operations (in thousands) | Item | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $1,029 | $2,364 | $(1,335) | | In-process research and development | $111,954 | $0 | $111,954 | | Research and development | $15,369 | $3,913 | $11,456 | | General and administrative | $6,005 | $2,922 | $3,083 | | Loss from operations | $(132,299) | $(4,471) | $(127,828) | - The $112.0 million IPR&D expense in Q1 2024 was due to the write-off of assets from Zentalis and Ayala with no alternative future use131 - R&D expenses increased by $11.5 million YoY, driven by outsourced research for preclinical programs and activities for AL102132134 - G&A expenses increased by $3.1 million YoY, mainly from higher personnel-related costs and professional fees135 Liquidity and Capital Resources Liquidity was boosted by a $215.4 million public offering, ensuring funding for at least the next 12 months - As of March 31, 2024, the company had cash, cash equivalents and marketable securities of $309.7 million and an accumulated deficit of $352.3 million138 - In February 2024, a follow-on public offering generated net proceeds of $215.4 million139 - In May 2024, the company established a $200.0 million 'at-the-market' (ATM) sales agreement, though no shares have been sold yet140 - Management expects existing cash and equivalents will fund operations for at least 12 months from the filing date147 Quantitative and Qualitative Disclosures about Market Risk The company is exempt from these disclosures as a smaller reporting company - As a smaller reporting company, Immunome is not required to provide this information158 Controls and Procedures Management concluded that disclosure controls and internal controls over financial reporting were effective as of March 31, 2024 - Management concluded that disclosure controls and procedures were effective as of March 31, 2024159 - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2024160 PART II – OTHER INFORMATION Legal Proceedings The company is not currently involved in any material legal proceedings - The company is not currently a party to any material legal proceedings162 Risk Factors Key risks include a history of losses, clinical trial challenges, reliance on third parties, and the need for future funding - The company has a history of significant operating losses, with an accumulated deficit of $352.3 million as of March 31, 2024, and expects to incur significant losses for the foreseeable future168 - The company faces substantial competition from companies with greater resources, including SpringWorks Therapeutics, Novartis, Eli Lilly, and Merck217220221 - The company relies on third parties for manufacturing, supply, and conducting clinical trials, creating risks outside of its direct control305307 - There are risks associated with protecting intellectual property, including potential patent challenges, high litigation costs, and difficulty protecting trade secrets329352383 - The company will need to raise substantial additional funds to advance its development candidates, and future financing may not be available on acceptable terms177 Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities were reported during the period - None447 Defaults Upon Senior Securities The company reports no defaults upon its senior securities - None448 Mine and Safety Disclosures This section is not applicable to the company's operations - Not applicable449 Other Information Max Rosett was appointed as the company's Chief Financial Officer on May 9, 2024 - On May 9, 2024, the Company's board of directors appointed Max Rosett as Chief Financial Officer ('CFO')450 - Mr. Rosett, age 34, had served as the Company's Interim Chief Financial Officer since December 2023451 Exhibits This section lists key agreements and certifications filed with the report - Key exhibits filed include the Sales Agreement for the ATM offering, the Asset Purchase Agreement with Ayala Pharmaceuticals, the License Agreement with Zentalis Pharmaceuticals, and officer certifications455