Group 1 - Many biotechs in the antibody-drug conjugate (ADC) space experienced a pullback throughout much of 2024, which offset a rally that occurred in late 2023 and early 2024 [1] - Immunome (NASDAQ: IMNM) was one of the companies affected by this downturn, despite a buy rating issued in April 2024 [1]

Core Insights - Hummingbird Bioscience has granted Immunome, Inc. an exclusive worldwide license for monoclonal antibodies targeting a single undisclosed target, highlighting the strategic partnership in developing targeted cancer therapies [1][2][3] Group 1: License Agreement Details - Under the license agreement, Immunome will handle the research, development, manufacturing, and commercialization of products using the licensed antibodies, while Hummingbird will receive an upfront payment along with future milestone payments and royalties [2] - The agreement emphasizes the value of Hummingbird's epitope-focused antibody discovery capabilities, with Immunome recognized for its experience in developing and commercializing novel antibody-drug conjugate (ADC) therapies [3] Group 2: Hummingbird Bioscience Overview - Hummingbird Bioscience is focused on discovering and developing transformative biologics for hard-to-treat diseases, building a pipeline of next-generation ADCs using proprietary antibody discovery and linker/payload platforms [4] - The company has several ADCs in preclinical development and is advancing monoclonal antibodies HMBD-001 (anti-HER3 mAb) and HMBD-002 (anti-VISTA mAb) in Phase I, with an out-licensed ADC (HMBD-501) set to enter clinical trials in 2025 [4] - Hummingbird employs a Rational Antibody Discovery (RAD) platform that integrates AI-enabled algorithms and immunization strategies to enhance the discovery of high-affinity antibodies, with multiple RAD-derived therapeutics currently in clinical development or partnered [3][4]

Core Viewpoint - Immunome, Inc. reported a quarterly loss of $0.78 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.60, marking a 30% earnings surprise [1][2] Financial Performance - The company posted revenues of $2.91 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 19.05%, and down from $3.57 million year-over-year [2] - Over the last four quarters, Immunome has surpassed consensus EPS estimates only once [2] - The current consensus EPS estimate for the upcoming quarter is -$0.63 on revenues of $5.11 million, and for the current fiscal year, it is -$4.18 on revenues of $7.65 million [7] Stock Performance - Immunome shares have increased by approximately 16.7% since the beginning of the year, compared to a 25.5% gain in the S&P 500 [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating it is expected to perform in line with the market in the near future [6] Industry Outlook - The Medical - Biomedical and Genetics industry is currently ranked in the top 26% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Financial Position - As of September 30, 2024, Immunome reported cash, cash equivalents, and marketable securities totaling $240.1 million, with a current cash runway expected to extend into 2026[4]. - The accumulated deficit as of September 30, 2024, was $435.5 million, an increase from $222.8 million at the end of 2023[7]. Revenue and Expenses - Collaboration revenue for Q3 2024 was $2.9 million, down from $3.6 million in Q3 2023[8]. - Research and development expenses for Q3 2024 were $37.2 million, including stock-based compensation costs of $1.8 million[4]. - In-process research and development expenses for Q3 2024 were $6.7 million, related to business development activities[4]. - General and administrative expenses for Q3 2024 were $9.5 million, including stock-based compensation expense of $3.1 million[4]. - Total operating expenses for Q3 2024 were $53.4 million, significantly higher than $8.2 million in Q3 2023[8]. Net Loss - Immunome reported a net loss of $47.1 million for Q3 2024, compared to a net loss of $4.3 million for Q3 2023[8]. Clinical Development - Full enrollment for the Phase 3 RINGSIDE Part B study of AL102 was completed in February 2024, with topline data expected in the second half of 2025[3]. - Immunome anticipates submitting INDs for IM-1021 and IM-3050 in the first quarter of 2025[3].

Company Performance - Immunome, Inc. reported a quarterly loss of $0.49 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.38, and compared to a loss of $0.46 per share a year ago, indicating an earnings surprise of -28.95% [1] - The company posted revenues of $2.36 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 9.77%, and down from $4.26 million in the same quarter last year [2] - Over the last four quarters, Immunome has surpassed consensus EPS estimates only once and has topped consensus revenue estimates just once [2] Stock Outlook - Immunome shares have increased approximately 20.8% since the beginning of the year, outperforming the S&P 500's gain of 12% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.42 on revenues of $2.63 million, and for the current fiscal year, it is -$3.66 on revenues of $5.55 million [7] - The estimate revisions trend for Immunome is mixed, resulting in a Zacks Rank 3 (Hold), indicating that shares are expected to perform in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Immunome belongs, is currently in the top 30% of over 250 Zacks industries, suggesting a favorable outlook for stocks within this sector [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact investor sentiment and stock performance [5]

Core Insights - Nectin Therapeutics has entered into an exclusive worldwide license agreement with Immunome for a panel of antibodies targeting an undisclosed target, allowing Immunome to develop and commercialize these antibodies [2][4] - The agreement enables Nectin to focus on its first-in-class anti-PVR program (NTX1088) and advance its novel antibody drug conjugates (ADCs) into clinical development [4] Company Overview - Nectin Therapeutics is a clinical-stage biotechnology company focused on developing innovative immunotherapies and ADCs to combat tumor resistance, with a diverse pipeline aimed at addressing major escape mechanisms of current immuno-oncology therapies [3] - The company is backed by several venture funds, including aMoon Fund, Peregrine Ventures, and the Cancer Focus Fund, and has a strong management team with extensive experience in oncology drug development [3] Strategic Implications - The partnership with Immunome is seen as a strategic move for Nectin to realize value from its assets while continuing to advance its clinical studies in high unmet need tumor types [4] - Immunome's expertise in developing and commercializing ADC therapies positions it as an ideal partner for Nectin to enhance the development of its promising assets [4]

Press Release Dr. Sarma brings exceptional expertise in all facets of the pharmaceutical and biotechnology business, from scaling platforms to developing therapeutics Geneva, Switzerland – July 9, 2024 – STALICLA SA, a Swiss neuro precision biotech company dedicated to developing precision medicine-based treatments for neurodevelopmental and neuropsychiatric disorders, such as autism spectrum disorder, announced today the appointment of Dr. Purnanand Sarma, PhD, as Chair of its Board of Directors. Dr. Sarma ...

nicolas_ AL102 Acquisition Rights Already Bring In Phase 3 Ready Asset ROR1 ADC And FAP RLT Are Two Highly Sought Out Clinical Targets Financials Risks To Business Immunome, Inc. (NASDAQ:IMNM) is an interesting biotech to consider, and that's because it has various therapy types it deploys for its pipeline. One of the lead assets it has is AL102, which is being explored in the ongoing phase 3 RINGSIDE study for the treatment of patients with desmoid tumors. Enrollment for Part B of this study was completed ...

Core Insights - Immunome, Inc. reported a quarterly loss of $0.34 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.80, marking an earnings surprise of 57.50% [1] - The company generated revenues of $1.03 million for the quarter ended March 2024, missing the Zacks Consensus Estimate by 74.28% and down from $2.36 million year-over-year [2] - Immunome shares have increased approximately 45.9% year-to-date, outperforming the S&P 500's gain of 9.5% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.36 on revenues of $4 million, while for the current fiscal year, it is -$1.91 on revenues of $16 million [7] - The estimate revisions trend for Immunome is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Immunome belongs, is currently ranked in the top 37% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

PART I – FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(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 million**[85](index=85&type=chunk) - 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 Pharmaceuticals[58](index=58&type=chunk)[69](index=69&type=chunk)[120](index=120&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The analysis details a higher net loss from IPR&D expenses and improved liquidity from a recent public offering [Overview and Pipeline](index=31&type=section&id=Overview) 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-4320[101](index=101&type=chunk) - AL102, an investigational GSI for desmoid tumors, is in a Phase 3 trial, with **topline data expected in H2 2025**[103](index=103&type=chunk)[105](index=105&type=chunk)[107](index=107&type=chunk) - The company plans to submit Investigational New Drug (IND) applications for IM-1021 and IM-3050 in **Q1 2025**[110](index=110&type=chunk)[113](index=113&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20operations) 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 use[131](index=131&type=chunk) - R&D expenses increased by **$11.5 million** YoY, driven by outsourced research for preclinical programs and activities for AL102[132](index=132&type=chunk)[134](index=134&type=chunk) - G&A expenses increased by **$3.1 million** YoY, mainly from higher personnel-related costs and professional fees[135](index=135&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20capital%20resources) 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 million**[138](index=138&type=chunk) - In February 2024, a follow-on public offering generated net proceeds of **$215.4 million**[139](index=139&type=chunk) - In May 2024, the company established a **$200.0 million 'at-the-market' (ATM) sales agreement**, though no shares have been sold yet[140](index=140&type=chunk) - Management expects existing cash and equivalents will fund operations for **at least 12 months** from the filing date[147](index=147&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is exempt from these disclosures as a smaller reporting company - As a smaller reporting company, Immunome is not required to provide this information[158](index=158&type=chunk) [Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) 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, 2024[159](index=159&type=chunk) - **No material changes** in internal control over financial reporting occurred during the quarter ended March 31, 2024[160](index=160&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=49&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently a party to any material legal proceedings[162](index=162&type=chunk) [Risk Factors](index=50&type=section&id=Item%201A.%20Risk%20Factors) 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 future[168](index=168&type=chunk) - The company faces **substantial competition** from companies with greater resources, including SpringWorks Therapeutics, Novartis, Eli Lilly, and Merck[217](index=217&type=chunk)[220](index=220&type=chunk)[221](index=221&type=chunk) - The company **relies on third parties** for manufacturing, supply, and conducting clinical trials, creating risks outside of its direct control[305](index=305&type=chunk)[307](index=307&type=chunk) - There are risks associated with **protecting intellectual property**, including potential patent challenges, high litigation costs, and difficulty protecting trade secrets[329](index=329&type=chunk)[352](index=352&type=chunk)[383](index=383&type=chunk) - The company will need to **raise substantial additional funds** to advance its development candidates, and future financing may not be available on acceptable terms[177](index=177&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=151&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None[447](index=447&type=chunk) [Defaults Upon Senior Securities](index=151&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon its senior securities - None[448](index=448&type=chunk) [Mine and Safety Disclosures](index=151&type=section&id=Item%204.%20Mine%20and%20Safety%20Disclosures) This section is not applicable to the company's operations - Not applicable[449](index=449&type=chunk) [Other Information](index=151&type=section&id=Item%205.%20Other%20Information) 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](index=450&type=chunk) - Mr. Rosett, age 34, had served as the Company's Interim Chief Financial Officer since December 2023[451](index=451&type=chunk) [Exhibits](index=152&type=section&id=Item%206.%20Exhibits) 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 certifications[455](index=455&type=chunk)