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IGM Biosciences Announces Third Quarter 2024 Financial Results and Provides Corporate Update

On November 8, 2024 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, reported its financial results for the fiscal quarter ended September 30, 2024 and provided an update on recent developments (Press release, IGM Biosciences, NOV 8, 2024, View Source [SID1234648025]).

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"The third quarter was transformative for IGM, punctuated by the announcement of our strategic pivot to focus exclusively on autoimmunity," said Mary Beth Harler, M.D., Chief Executive Officer of IGM Biosciences. "Our near-term focus for imvotamab remains generating robust initial data sets in rheumatoid arthritis, systemic lupus erythematosus and myositis. Based on enrollment timing, we expect to have sufficient information by the middle of 2025 to present initial imvotamab data at an appropriate venue as well as determine next steps to advance imvotamab in autoimmune indications."

Pipeline Updates

Imvotamab (CD20 x CD3 T cell engager)

•Clinical development of imvotamab in autoimmune diseases advances, with initial clinical data disclosure expected by mid-2025.
•
hird dose cohort in rheumatoid arthritis successfully completed. The Company has cleared the third dose cohort of its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis.
•Enrollment in second dose cohort in systemic lupus erythematosus ongoing. The Company has cleared the first dose cohort of its open-label clinical study testing imvotamab in severe systemic lupus erythematosus (SLE) and is currently enrolling patients in a second dose cohort.
•First patient dosed in myositis. The Company has dosed the first patient in its single arm, open-label clinical study testing imvotamab in moderate-severe idiopathic inflammatory myopathies (myositis). Enrollment is ongoing in this study, which is being conducted in collaboration with Stanford University.
•Imvotamab preclinical data selected for poster presentation at ACR Convergence 2024. The Company will present a poster titled "Imvotamab, a CD20-Targeted Bispecific IgM T Cell Engager, Effectively Depletes Low-Expressing CD20+ B Cells in Preclinical Models of Autoimmune Disease" at the American College of Rheumatology’s annual meeting, ACR Convergence 2024, taking place in Washington, D.C., on November 17, 2024.
IGM-2644 (CD38 x CD3 T cell engager)

•Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company continues to make significant progress towards initiating clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the
treatment of autoimmune diseases. The Company expects to enter IGM-2644 into a single arm, open-label clinical study for generalized myasthenia gravis (gMG) by the end of 2024.
Corporate Updates

•Peer-reviewed article titled "Cutting-edge Approaches to B-cell Depletion in Autoimmune Diseases" published in Frontiers in Immunology. IGM co-authored this article with Bill Robinson, M.D., Ph.D., et al. and the article can be found online here. Dr. Robinson is Chief of the Division of Immunology and Rheumatology at Stanford University.
•Eric Humke, M.D., Ph.D., Senior Vice President, appointed as Head of Clinical Research and Development. Dr. Humke joined IGM in 2019 as Vice President, Clinical Development. Prior to IGM, he spent eight years at Genentech, most recently serving as Senior Medical Director, where he led the early clinical development of multiple first-in-human therapeutics. Prior to joining Genentech, he was an Instructor of Medicine at the Stanford University School of Medicine, where he conducted basic science research and cared for patients.
Third Quarter 2024 Financial Results

•Cash and Investments: Cash and investments as of September 30, 2024 were $218.8 million, compared to $337.7 million as of December 31, 2023.
•Collaboration Revenue: For the third quarter of 2024, collaboration revenues were $0.5 million, compared to $0.5 million for the third quarter of 2023.
•Research and Development (R&D) Expenses: For the third quarter of 2024, R&D expenses were $46.1 million, compared to $54.8 million for the third quarter of 2023. R&D expenses for the third quarter of 2024 included $5.5 million in one-time expenses related to the strategic pivot to focus exclusively on autoimmunity.
•General and Administrative (G&A) Expenses: For the third quarter of 2024, G&A expenses were $18.8 million, compared to $12.5 million for the third quarter of 2023. G&A expenses for the third quarter of 2024 included $8.5 million in one-time expenses related to the strategic pivot to focus exclusively on autoimmunity.
•Net Loss: For the third quarter of 2024, net loss was $61.4 million, or a loss of $1.01 per share, compared to a net loss of $62.0 million, or a loss of $1.04 per share, for the third quarter of 2023.

2024 Financial Guidance

The Company expects full year 2024 GAAP operating expenses of $215 million to $225 million including estimated non-cash stock-based compensation expense of approximately $40 million, and full year collaboration revenue of approximately $2 million related to the Sanofi agreement. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments and for the balance to enable it to fund its operating expenses and capital expenditure requirements into 2027.

Delcath Systems Reports Third Quarter 2024 Results and Business Highlights

On November 8, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported financial results and business highlights for the third quarter ended September 30, 2024 (Press release, Delcath Systems, NOV 8, 2024, View Source [SID1234648024]).

Third Quarter and Recent Business Highlights

Total third quarter revenues of $11.2 million, up 44% from the prior quarter, including $10.0 million from HEPZATO KIT (melphalan/Hepatic Delivery System) and $1.2 million from CHEMOSAT;
Activated four HEPZATO treatment centers in the U.S. during the third quarter and one more in October, bringing the total to twelve active centers; another center has scheduled their first treatment in November with a further 10 centers having partially or fully completed preceptorship training;
Reported that CHOPIN, an investigator-initiated study which is evaluating the effect of sequencing immunotherapy with CHEMOSAT liver directed therapy, is now fully enrolled with 76 patients;
Ended the third quarter with cash and investments of $14.0 million with quarterly cash burn of $3.6 million; and
Subsequent to September 30, 2024:
Submitted the final principal and interest payments of $2.8 million on the Rosalind note payable and as a result have no outstanding debt obligations; and
All remaining Tranche B warrants from the March 29, 2023 PIPE were exercised by the November 6, 2024 expiration date resulting in approximately $25 million in proceeds.
"We are pleased with HEPZATO’s robust market adoption in the U.S., a testament to its clinical impact and the confidence physicians are showing in its use," said Gerard Michel, Delcath’s Chief Executive Officer. "Given our strong balance sheet and consistent revenue growth, which puts us on the cusp of profitability, Delcath is in a solid position to expand our development pipeline. Based on broad interest from oncology leaders, we are advancing programs for the use of HEPZATO in liver dominant colorectal and breast cancers."

Recent Publications

Presented subgroup analyses data from the FOCUS Phase 3 trial of HEPZATO at ESMO (Free ESMO Whitepaper) 2024, demonstrating similar outcomes in overall survival, overall response rate, and progression free survival between patients with and without extrahepatic lesions or based on prior therapy. In addition, tumor responses were observed throughout the entire treatment period supporting the strategy to continue treatment until best response is achieved;
Announced multiple independent investigator-sponsored retrospective studies of HEPZATO and CHEMOSAT:
A 30-patient study published in the Annals of Surgical Oncology by researchers at Moffitt Cancer Center in Tampa, Florida. The study reported that HEPZATO used in first- or second-line therapy for metastatic uveal melanoma provided better disease control in the liver and improved progression-free survival compared to both immunotherapy and other liver-directed therapies;
A 167-patient study published in the journal Therapeutic Advances in Medical Oncology by investigators from the University of Tübingen, Germany. The study reported that first-line liver-directed therapies, including CHEMOSAT, significantly improve melanoma-specific survival in patients with liver metastases from uveal melanoma, compared to first-line systemic therapies; and
A study published in the ESMO (Free ESMO Whitepaper) journal of Gastrointestinal Oncology by researchers from the University Hospital of Leipzig reporting the results of 33 patients treated with CHEMOSAT. The study included previously treated patients with unresectable intrahepatic metastases from seven different cancer types and reported a hepatic disease control rate of 91% with six patients (18.2%) achieving complete response in the liver. Median hepatic progression-free survival was 52 weeks across all patients.
Third Quarter 2024 Results

Total revenue for the quarter ended September 30, 2024 was $11.2 million compared to $0.4 million for the same period in the prior year. Revenue includes sales of $10.0 million of HEPZATO in the U.S. and $1.2 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ended September 30, 2024, were $3.9 million compared to $4.7 million for the same period in the prior year. The change in research and development expenses is primarily due to lower costs associated with expanded access protocol incurred in previous periods offset by an increase in medical affairs and regulatory costs associated with an approved product.

Selling, general and administrative expenses for the quarter ended September 30, 2024, were $7.0 million compared to $6.2 million for the same period in the prior year. The increase primarily relates to commercial launch activities including marketing-related expenses and additional personnel in the commercial team.

The Company submitted the final principal payment due to Avenue Venture Opportunities Fund, L.P. on August 1, 2024 for the Loan and Security Agreement entered into in August 2021. As of September 30, 2024 our cash and investments totaled $14.0 million.

Subsequent to the end of the third quarter, we submitted the final principal and interest payment of $2.8 million on the outstanding Rosalind note payable and received approximately $25 million in proceeds from the exercise of Tranche B Warrants from the previous March 29, 2023 PIPE. Currently, there are no outstanding debt obligations.

Aptose Reports Results for the Third Quarter 2024

On November 8, 2024 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, reported financial results for the three months ended September 30, 2024, and provided a corporate update (Press release, Aptose Biosciences, NOV 8, 2024, View Source [SID1234648020]).

"Triple drug therapies (triplets) that build on the standard of care in AML have yielded higher response rates yet are limited to specific subpopulations and often cause myelosuppression and other toxicities," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Tuspetinib, with its breadth of activity and unique safety profile, is a potential game-changer as part of a triplet therapy regimen and we continue to advance its development."

Key Corporate Highlights

Aptose Facility Agreement with Hanmi – During the quarter, Aptose announced that it received a $10 million loan through a Facility Agreement with Hanmi Pharmaceutical Co. ("Hanmi"), and that the companies are actively negotiating a new tuspetinib co-development collaboration agreement intended to provide additional support to accelerate the clinical development of tuspetinib. The loan is convertible as prepayment of milestone obligations under the future collaboration agreement or repayable after the expected completion of a triple drug combination trial with tuspetinib in newly diagnosed AML patients. Aptose plans to use the proceeds from such loan for the development of tuspetinib.
Tuspetinib Data Drives Interest as Treatment Paradigm for AML Shifts to Triplet Therapy – During our APTIVATE trial, tuspetinib (TUS) as a monotherapy and in combination treatment with venetoclax in a very ill AML patient population safely demonstrated broad clinical activity in AML patients with diverse mutation profiles, including those with adverse genetics. As presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Congress in June, tuspetinib potently targets SYK, FLT3, mutated KIT, JAK1/2, and RSK2 kinases, yet avoids many typical toxicities, drug-related discontinuations, and deaths observed with other agents. In the APTIVATE trial, TUS achieved broad activity across AML patients with a diverse array of mutations, both as a single agent (TUS) and in combination with venetoclax (TUS+VEN) in very ill relapsed/refractory (R/R) and heavily pre-treated AML populations. Responses were observed in patients with Prior-VEN, Prior-FLT3 inhibitor (FLT3i), and Prior-HSCT therapies, those with highly adverse genetics, including mutations in TP53 and RAS genes, and those with mutated or unmutated (wildtype) FLT3 genes. Patients naïve to VEN therapy achieved higher response rates. TUS appears to be an ideal third agent to add to a venetoclax and hypomethylating agent regimen. These data support the launch of the triplet therapy trial in newly diagnosed AML patients who are ineligible to receive induction chemotherapy, irrespective of their FLT3 mutation status. Other triplet therapies in development can achieve high response rates but are limited by toxicities and inability to treat certain AML populations, leaving an unmet need that may be addressed with the addition of tuspetinib. With Hanmi’s support, Aptose plans to initiate its planned triplet combination study during the quarter and to treat patients with and without FLT3 mutations. In addition, the company is evaluating other co-development opportunities to further expand the role of tuspetinib in other settings.
Nasdaq – Aptose has a scheduled meeting with the Nasdaq Listing Qualifications during the current quarter to address compliance with the minimum requirement of $2.5 million in stockholders’ equity (the "Stockholders’ Equity Requirement") and Aptose continues to work on its compliance with minimum $1.00 per share closing bid price for thirty (30) consecutive business days, needed for continued listing on Nasdaq (the "Minimum Bid Price Requirement").

On April 2, 2024, the Company received a deficiency letter from Nasdaq stating that the Company was not in compliance with the Stockholders’ Equity Requirement. The Company submitted a Compliance Plan to Nasdaq on this issue on May 17, 2024 and received an extension to meet this Nasdaq requirement by September 30, 2024. On October 1, 2024, the Company received a letter from Nasdaq stating that the Company did not meet the terms of the extension because it did not complete its proposed financing initiatives to regain compliance. On October 8, 2024, the Company requested an appeal and hearing; such hearing is scheduled for November 21, 2024.

On July 16, 2024, Aptose announced that it had received a deficiency letter notifying the Company that was not in compliance with the Minimum Bid Price Requirement. This deficiency letter has no immediate effect on the listing of the Company’s common shares, and its common shares will continue to trade on The Nasdaq Capital Market under the symbol "APTO" at this time. The Company’s common shares continue to trade on the Toronto Stock Exchange ("TSX") under the symbol "APS". The Company’s listing on the TSX is independent and will not be affected by the Nasdaq listing status. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been given one hundred and eighty (180) calendar days, or until January 13, 2025, to regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance with the Minimum Bid Price Requirement by January 13, 2025, the Company may, at Nasdaq’s discretion, be afforded a second one hundred and eighty (180) calendar day period to regain compliance, but if Nasdaq does not grant such extension, the Company’s common shares could be delisted from Nasdaq.

Immunocore to present at upcoming investor conferences

On November 08, 2024 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported that management will participate in the following investor conferences in November (Press release, Immunocore, NOV 8, 2024, View Source [SID1234648023]).

-Guggenheim Securities Healthcare Innovation Conference
Fireside Chat: Tuesday, November 12, 2024, at 1:00 p.m. EST

-Jefferies London Healthcare Conference
Fireside Chat: Wednesday, November 21, 2024, at 9:00 a.m. GMT

The presentations will be webcast live and can be accessed by visiting ‘Events & Presentations’, under ‘Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentations will be made available for a limited time.

Immatics Announces Multiple Presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on TCR-T Therapy Candidates Targeting PRAME

On November 8, 2024 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported an expanded clinical dataset from the ongoing Phase 1b dose expansion clinical trial for ACTengine IMA203 in addition to updated Phase 1 dose escalation clinical data on its next-generation ACTengine IMA203CD8 TCR-T cell therapy (Press release, Immatics, NOV 8, 2024, View Source [SID1234648022]). For the first time, the Company also reported preclinical data on other next-generation T cell candidates and combination strategies as part of its strategy to further exploit opportunities in additional solid tumor types within its PRAME franchise.

All dates and times of Immatics’ upcoming oral and poster presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) are available here. The data slides are accessible in the ‘Events & Presentations’ section of the Investor & Media section of the Company’s website.

"Immatics remains fully focused on the clinical development of our most advanced lead product candidate, IMA203, in second-line or later metastatic melanoma patients. We look forward to the initiation of SUPRAME, the registration-enabling Phase 3 trial, in December," said Dr. Cedrik Britten, Chief Medical Officer at Immatics. "Today, we also provide an update on our first, next-generation cell therapy, IMA203CD8, which is designed to achieve enhanced anti-tumor activity. The data announced confirm IMA203CD8’s enhanced pharmacology and potency per cell in patients. These attributes highlight the potential of this therapy in hard-to-treat solid tumors with medium-level PRAME copy numbers, including ovarian, endometrial and triple-negative breast cancer. The next step will be to further increase the cell dose to assess the full clinical potential of IMA203CD8 beyond melanoma. In addition, we strive to continuously improve the potential therapeutic benefit for patients with a range of PRAME-positive cancers through the expansion of our PRAME franchise."

ACTengine IMA203 Monotherapy Phase 1b Trial – Clinical Data and Development Path Summary

On October 10, 2024, Immatics provided a data update on IMA203 monotherapy in 281 heavily pretreated metastatic melanoma patients from the ongoing Phase 1b dose expansion part of the clinical trial in which patients were treated at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR-T cells).

The data announced today include all infused patients in the Phase 1b dose expansion part of the trial (N=412), consisting of the 28 melanoma patients reported on October 10, 2024, and 13 non-melanoma patients, of which 10 non-melanoma patients were reported on November 8, 2023.

IMA203 monotherapy has maintained a favorable tolerability profile with no treatment-related Grade 5 events in the entire safety population (N=703 Phase 1a and Phase 1b patients across all dose levels and all tumor types).

Best Overall Response for IMA203 in Dose Expansion in All Indications (N=41#)

Data cut-off Aug 23, 2024; #First tumor assessment post infusion pending for 2/28 melanoma patients at data-cut; *Maximum change of target lesions and RECIST1.1 response at different timepoints. 1Patient A-DL5-23 is off study at data cut-off; 2Patient received one dose nivolumab erroneously.

Development Path for IMA203
Based on the Phase 1b data, the Company is on track to commence SUPRAME, the registration-enabling Phase 3 randomized-controlled clinical trial in melanoma for IMA203, in December 2024.

SUPRAME will evaluate IMA203 targeting PRAME in 360 HLA-A*02:01-positive patients with second-line or later (2L+) unresectable or metastatic melanoma who have received prior treatment with a checkpoint inhibitor. Patients will be randomized 1:1 for IMA203 or investigator’s choice of selected approved treatments in the 2L+ setting, including nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (US only) or chemotherapy. The primary endpoint for full approval will be median PFS and secondary endpoints will include objective response rate, safety, duration of response, no overall survival detriment and patient-reported outcomes.

Patient enrollment for SUPRAME is forecast to be completed in 2026, and a pre-specified interim analysis is planned for early 2026. Immatics aims to submit a Biologics License Application (BLA) in early 2027 for full approval.

ACTengine IMA203CD8 (GEN2) Monotherapy Phase 1 Dose Escalation Trial – Patient Population & Clinical Data Summary

Patient population: Heavily pretreated patients with solid tumors
As of data cut-off on September 30, 2024, 444 heavily pretreated HLA-A*02:01 and PRAME-positive patients with solid tumors were infused with IMA203CD8 monotherapy across four escalating dose levels, of which 415 patients were evaluable for efficacy. The median total infused dose was 1.48×109 TCR-T cells, and the patient population is composed of patients with a median of three lines of prior systemic treatments.

Safety: Treatment with IMA203CD8 demonstrates a manageable tolerability profile across dose levels
IMA203CD8 monotherapy has maintained a manageable tolerability profile in the 44 patients treated. The most frequent adverse events at or above Grade 3 were expected cytopenia associated with lymphodepletion. Some patients also experienced mild to moderate CRS (Grade 1: 36% Grade 2: 48% Grade 3: 11% Grade 4: 2%).

As previously reported, two patients experienced dose-limiting toxicities at dose level 4b, which prompted a dosing adjustment to dose level 4a. After further assessing the tolerability profile of IMA203CD8 in additional patients treated at dose level 4a, the eligibility criteria and the IL-2 dose regimen were modified, and dose escalation beyond dose level 4a was reinitiated. One Grade 5 adverse event classified as possibly related to treatment with IMA203CD8 was also observed as reported previously in March 2024. The maximum tolerated dose has not yet been determined.

Anti-tumor activity and durability: Deep and durable objective responses observed

As of data cut-off on September 30, 2024, 10 of 17 responses were ongoing, of which three confirmed responses were ongoing at 14+, 15+ and 24+ months.
Of note, these patients had been treated at substantially lower doses compared to IMA203 (GEN1), i.e. in a range of 0.2-0.48×109 TCR-T cells/m2 BSA (dose level 3) to 0.801-1.2×109 TCR-T cells/m2 BSA (dose level 4c) T cells infused.
Deep responses with ≥50% tumor size reduction were observed in 11 out of 17 responders. This group included two patients with complete response of target lesions, of which one patient showed a complete metabolic response according to PET-CT scan6.
41% (14/34) confirmed objective response rate (cORR) and 41% (17/41) objective response rate (ORR).
Median duration of response (mDOR) of 9.2 months at a median follow-up (mFU) of 13.1 months.
Tumor shrinkage7 of 84% (32/38) and disease control rate8 at week 6 of 85% (34/40).
Translational data: Opportunity of IMA203CD8 in medium-level PRAME expressing indications
Translational data indicate that PRAME expression level is associated with clinical activity in IMA203 and IMA203CD8 treated patients. Both IMA203 and IMA203CD8 achieved deep responses despite IMA203CD8 patients receiving lower product doses. Based on the enhanced pharmacology of IMA203CD8, the evaluation of higher doses of IMA203CD8 in the ongoing dose escalation trial opens the possibility of addressing hard-to-treat solid tumor indications with a medium-level of PRAME copy numbers, such as ovarian cancer, endometrial cancers and triple-negative breast cancer.

Preclinical Data on New Approaches for TCR-T Based Cell Therapies

As part of Immatics’ long-term strategy to expand its PRAME franchise, the Company has conducted preclinical studies for the potential future clinical development of next-generation TCR-T-based cell therapies targeting PRAME to further enhance the efficacy and durability of IMA203. These efforts include the evaluation of TCR-T cells armored with membrane-bound IL-15 (mbIL15) targeting tumor types with low PRAME copy numbers, such as squamous non-small-cell lung cancer and squamous head and neck cancers. In addition, the Company is developing an allogeneic cell therapy approach to further increase commercial attractiveness and to reach patients quickly with its next-generation off-the-shelf cell therapy, ACTallo. The preclinical data will be presented during poster sessions at SITC (Free SITC Whitepaper).

About ACTengine IMA203, IMA203CD8 and Target PRAME
ACTengine IMA203 is Immatics’ most advanced TCR-based autologous cell therapy that is directed against an HLA-A*02-presented (human leukocyte antigen) peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers. PRAME is homogeneously and specifically expressed in tumor tissue and Immatics’ PRAME peptide is present at a high copy number per tumor cell. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform, XPRESIDENT. Through its proprietary TCR discovery and engineering platform XCEPTOR, Immatics has generated a highly specific T cell receptor (TCR) against this target for ACTengine IMA203.

ACTengine IMA203 TCR-T is currently being evaluated as a monotherapy in a Phase 1 clinical trial in patients with solid tumors expressing PRAME, such as cutaneous melanoma. An IMA203 registration-enabling randomized controlled Phase 3 trial, "SUPRAME," is planned to commence in December 2024.

ACTengine IMA203 TCR-T is also currently being evaluated in Phase 1 IMA203CD8 (GEN2) monotherapy, where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor.