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 Performance - 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[121] - The net loss for the three months ended September 30, 2024 was $47.1 million, compared to a net loss of $4.3 million for the same period in 2023, representing an increase of $42.8 million[119] - Total operating expenses for the nine months ended September 30, 2024 were $229.1 million, an increase of $204.1 million compared to $25.1 million for the same period in 2023[132] - Net loss for the nine months ended September 30, 2024 was $212.7 million, compared to a net loss of $14.2 million for the same period in 2023[143] - 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 same period in 2024[134] Expenses - Research and development expenses increased significantly to $37.2 million for the three months ended September 30, 2024, compared to $3.8 million for the same period in 2023, reflecting an increase of $33.4 million[119] - General and administrative expenses rose to $9.5 million for the three months ended September 30, 2024, up by $5.2 million from $4.4 million in the same period in 2023[119] - The total operating expenses for the three months ended September 30, 2024 were $53.4 million, an increase of $45.2 million compared to $8.2 million for the same period in 2023[119] - 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 same period in 2024[140] - In-process research and development expense for the nine months ended September 30, 2024 was primarily related to the write-off of acquired IPR&D assets[134] Cash Flow and Financing - Cash used in operating activities for the nine months ended September 30, 2024 was $68.7 million, primarily due to a net loss of $212.7 million[147] - 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 a public offering[151] - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities of $240.1 million[143] - As of September 30, 2024, the company anticipates that existing cash and marketable securities will fund operations for at least 12 months, but additional financing will be necessary for ongoing research and development[154] - The company plans to finance cash needs through equity offerings, debt financings, collaborations, and licensing arrangements, amid global financial market volatility[156] Research and Development - AL102, the clinical asset, demonstrated an overall objective response rate (ORR) of 61% in evaluable patients during the RINGSIDE Part A trial, with a 75% ORR in the 1.2 mg daily dosing cohort[102] - The Phase 3 trial RINGSIDE Part B enrolled 156 patients with histologically confirmed desmoid tumors, with the primary endpoint being progression-free survival[104] - IM-1021, a preclinical stage ADC targeting ROR1, showed sustained tumor regression in a mouse model of triple-negative breast cancer, outperforming a competitor's ADC[107] - IM-3050, a FAP-targeted radioligand therapy, is designed to deliver radioactive Lu-177 to FAP-expressing cells, which are present in approximately 75% of solid tumors[109] - The company expects to submit IND applications for both IM-1021 and IM-3050 to the FDA in the first quarter of 2025[108][110] Future Outlook - The company expects substantial increases in expenses related to clinical development of AL102 and other product candidates, as well as business development strategies[153] - Future funding requirements will depend on various factors, including the acquisition of products and technologies, costs of clinical trials, and regulatory review outcomes[155] - There are no material non-cancelable purchase commitments, and expected cash requirements do not include potential contingent payments related to asset acquisitions[157] Accounting and Compliance - The company qualifies as an "emerging growth company," allowing it to take advantage of reduced disclosure requirements until certain revenue or market value thresholds are met[165] - The company has elected not to "opt out" of the extended transition period for complying with new accounting standards, which may affect comparability with other public companies[166]

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]

Financial Performance - 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[107]. - The net loss for the three months ended June 30, 2024, was $36.1 million, compared to a net loss of $5.6 million for the same period in 2023, representing an increase of $30.5 million[105]. - Net loss for the six months ended June 30, 2024 was $165.6 million, compared to a net loss of $9.8 million for the same period in 2023[124]. - Cash used in operating activities for the six months ended June 30, 2024 was $34.6 million, primarily due to a net loss of $165.6 million[127]. - 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[113]. Operating Expenses - Total operating expenses increased by $32.3 million, from $10.0 million for the three months ended June 30, 2023, to $42.4 million for the three months ended June 30, 2024[105]. - 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[105]. - General and administrative expenses rose 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[105]. - Total operating expenses for the six months ended June 30, 2024 were $175.7 million, an increase of $158.8 million compared to $16.9 million for the same period in 2023[115]. - Research and development expenses for the six months ended June 30, 2024 increased by $34.8 million, from $9.6 million for the same period in 2023 to $44.5 million[117]. - 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 same period in 2024[121]. Cash and Funding - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities of $278.4 million[124]. - 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 a public offering[130]. - The company expects its existing cash, cash equivalents, and marketable securities as of June 30, 2024, to fund current and planned operating expenses and capital expenditures for at least 12 months[132]. - Future funding requirements will depend on various factors, including the acquisition of products and technologies, costs of clinical trials, and regulatory review outcomes[132]. - The company plans to finance cash needs through equity offerings, debt financings, collaborations, and licensing arrangements due to the volatility in global credit and financial markets[133]. - There are no material non-cancelable purchase commitments, and expected cash requirements do not include potential contingent payments related to asset acquisitions and license agreements[134]. Research and Development - AL102, the clinical asset, demonstrated an overall objective response rate (ORR) of 61% in evaluable patients during the RINGSIDE Part A trial, with a 75% ORR in the 1.2 mg daily dosing cohort[90]. - The Phase 3 trial RINGSIDE Part B enrolled 156 patients with histologically confirmed desmoid tumors, with the primary endpoint being progression-free survival[92]. - IM-1021, a preclinical ADC targeting ROR1, showed superior tumor volume reduction compared to a competitor in preclinical studies[94]. - IM-3050, a FAP-targeted radioligand therapy, is expected to submit an IND to the FDA in the first quarter of 2025[96]. - Research and development costs include salaries, clinical development expenses, and amounts incurred under license agreements, and are expensed as incurred[137]. - The company estimates research and development expenses based on contracts with third-party service providers, which may lead to differences between estimated and actual costs[138]. - The company monitors clinical trial activities and accrues costs based on the estimated amount of work completed, which may vary from actual expenses[139]. Regulatory and Compliance - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to take advantage of reduced disclosure requirements[142]. - The company may rely on exemptions from certain disclosure requirements until it no longer qualifies as an emerging growth company[144]. - The reported results of operations may not be directly comparable to those of other public companies due to the extended transition period for complying with new accounting standards[144]. Future Expectations - The company expects expenses to increase substantially as it advances clinical development of AL102 and seeks regulatory approval[131].

Financial Performance - Immunome reported a net loss of $36.1 million for the quarter ended June 30, 2024, compared to a net loss of $5.6 million for the same period in 2023[3][7]. - Total operating expenses for Q2 2024 were $42.4 million, significantly higher than $10.0 million in Q2 2023[7]. - Research and development expenses for Q2 2024 were $29.1 million, including stock-based compensation costs of $1.0 million[3]. - The company incurred in-process research and development expenses of $6.3 million in Q2 2024 related to business development activities[3]. - Immunome's accumulated deficit increased to $388.4 million as of June 30, 2024, compared to $222.8 million at the end of 2023[6]. Cash and Assets - As of June 30, 2024, Immunome reported cash, cash equivalents, and marketable securities totaling $278.4 million, with a cash runway expected to extend into 2026[2]. - Immunome's total assets increased to $296.2 million as of June 30, 2024, up from $148.5 million at the end of 2023[6]. 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[2]. - Immunome plans to submit INDs for IM-1021 and IM-3050 in Q1 2025[2]. - The company identified multiple promising ADC targets, all offering first-in-class potential, to expand its pipeline[1].

Nectin Contact: Fabian Tenenbaum Chief Executive Officer [email protected] +1 201 218-1774 SOURCE Nectin Therapeutics "Immunome believes the next generation of transformative antibody drug conjugates will address novel targets by pairing high-quality antibodies with innovative linker-payload technology," said Clay Siegall, PhD, President and Chief Executive Officer of Immunome. "We appreciate the work Nectin has done on these antibodies and look forward to advancing them further." Under the terms of the agr ...

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 ...