On May 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 March 31, 2024 and provided an update on recent developments (Press release, IGM Biosciences, MAY 8, 2024, View Source [SID1234642878]).

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"We are pleased to have exceeded our enrollment target of 110 patients in our randomized study of 3 mg/kg of aplitabart plus FOLFIRI and bevacizumab in second line colorectal cancer," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "While we are still scheduling first doses for a few patients, we expect that final enrollment in this clinical trial will exceed 120 patients. We are also pleased that we have completed enrollment in the first dose cohort of our clinical trial of imvotamab in severe rheumatoid arthritis."

Pipeline Updates

Aplitabart (DR5 agonist)

Clinical development of aplitabart advances.
Enrollment target exceeded in ongoing randomized colorectal cancer clinical trial. The Company has exceeded its target of enrolling 110 patients in its randomized clinical trial of 3 mg/kg of aplitabart, a death receptor 5 agonist, plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer. Patients have been enrolled across multiple clinical trial sites in the United States, Asia and Europe. This randomized trial is designed to assess the benefit of 3 mg/kg of aplitabart when administered in combination with FOLFIRI and bevacizumab compared to the current standard of care treatment of FOLFIRI and bevacizumab, with a primary endpoint of progression-free survival (PFS). The release of data from this randomized clinical trial will be dependent upon the timing of PFS events in both the control and the experimental arms of this study. Based on its assumptions as to the timing of PFS events, the Company expects to be able to release top-line PFS results from this study by the end of the first quarter of 2025.
Enrollment target met in 10 mg/kg dose single arm colorectal cancer clinical trial. The Company has also met its target of enrolling 20 patients in its single arm clinical study of 10 mg/kg of aplitabart in combination with FOLFIRI and bevacizumab in the treatment of later line colorectal cancer patients.
Imvotamab (CD20 x CD3)

Clinical development of imvotamab in autoimmune diseases advances.
Enrollment completed in first dose cohort of imvotamab in rheumatoid arthritis. The Company has completed enrollment in the first dose cohort of its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis. In this first dose cohort, the Company treated six patients with imvotamab and two patients with a placebo. The Company plans to enroll two additional dose cohorts, each consisting of six patients treated with imvotamab and two patients treated with a placebo. The doses of imvotamab received in the second dose cohort are planned to be higher than those received in the first dose cohort, and the doses of imvotamab received in the third dose cohort are planned to be higher than those received in the second dose cohort. This clinical study is now being expanded to include international clinical trial sites, in addition to sites in the United States.
Enrollment continues in first dose cohort of imvotamab in severe systemic lupus erythematosus. The Company also continues to enroll patients in the first dose cohort of its single arm, open-label clinical study testing imvotamab in severe systemic lupus erythematosus (SLE). All six patients treated in the first SLE dose cohort will receive imvotamab. The Company also plans to enroll two additional dose cohorts, each consisting of six patients treated with imvotamab. The doses of imvotamab received in the second dose cohort are planned to be higher than those received in the first dose cohort, and the doses of imvotamab received in the third dose cohort are planned to be higher than those received in the second dose cohort.
Enrollment to begin in myositis. The Company is currently initiating a clinical trial of imvotamab in idiopathic inflammatory myopathies (myositis). The Company expects to begin recruiting patients for this clinical trial in the current quarter.
IGM-2644 (CD38 x CD3)

Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company continues to make plans to begin clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases.
First Quarter 2024 Financial Results

Cash and Investments: Cash and investments as of March 31, 2024 were $293.8 million, compared to $337.7 million as of December 31, 2023.
Collaboration Revenue: For the first quarter of 2024 and 2023, collaboration revenues were $0.5 million in each quarter.
Research and Development (R&D) Expenses: For the first quarter of 2024, R&D expenses were $43.8 million, compared to $50.9 million for the first quarter of 2023.
General and Administrative (G&A) Expenses: For the first quarter of 2024, G&A expenses were $10.5 million, compared to $13.0 million for the first quarter of 2023.
Net Loss: For the first quarter of 2024, net loss was $49.8 million, or a loss of $0.83 per share, compared to a net loss of $59.3 million, or a loss of $1.33 per share, for the first quarter of 2023.
2024 Financial Guidance

The Company expects full year 2024 GAAP operating expenses of $210 million to $220 million including estimated non-cash stock-based compensation expense of approximately $40 million. As a result of the refocusing of the Sanofi collaboration announced in April 2024, the Company expects to recognize full year collaboration revenue of approximately $63 million, of which $62 million is expected to be recognized in the second quarter of 2024. This collaboration revenue relates to accounting recognition of the upfront $150 million payment received from Sanofi in 2022 and will not impact the Company’s cash balance or runway. 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 the second quarter of 2026.

On May 8, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the company generated revenue of $638 million for the first quarter ended March 31, 2024, compared to $602 million for the same period of 2023 (Press release, Exact Sciences, MAY 8, 2024, View Source [SID1234642876]).

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"The Exact Sciences team is off to a strong start again in 2024. Our team delivered more than a million Cologuard and Oncotype DX test results to patients and advanced our deep pipeline of life-changing cancer diagnostics," said Kevin Conroy, chairman and CEO. "As we expand our portfolio globally, our seamless customer experience, powerful commercial engine, and high-quality lab and technology foundation will continue to gain momentum, supporting our mission to help eradicate cancer."

First-quarter 2024 financial results

For the three-month period ended March 31, 2024, as compared to the same period of 2023 (where applicable):

Total revenue was $638 million, an increase of 6 percent on a reported and core revenue basis
Screening revenue was $475 million, an increase of 7 percent
Precision Oncology revenue was $163 million, an increase of 5 percent, or 4 percent on a core revenue basis
Gross margin including amortization of acquired intangible assets was 70 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 73 percent
Net loss was $110 million, or $0.60 per share, compared to a net loss of $74 million, or $0.42 per share
EBITDA was $(47) million and adjusted EBITDA was $39 million
Cash used in operating activities was $82 million and free cash flow was $(120) million,
Cash, cash equivalents, and marketable securities were $652 million at the end of the quarter
Screening primarily includes laboratory service revenue from Cologuard tests and PreventionGenetics. Precision Oncology includes laboratory service revenue from global Oncotype DX and therapy selection tests.

2024 outlook

The company has maintained its revenue guidance of $2.810-$2.850 billion during 2024, assuming:

Screening revenue of $2.155-$2.175 billion, and
Precision Oncology revenue of $655-$675 million.
First-quarter 2024 conference call & webcast

Company management will host a conference call and webcast on Wednesday, May 8, 2024, at 5 p.m. ET to discuss first-quarter 2024 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608. A replay of the webcast will be available at exactsciences.com. The webcast, conference call, and replay are open to all interested parties.

On May 8, 2024 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported business updates and provided financial results for the fiscal quarter ended March 31, 2024 (Press release, Erasca, MAY 8, 2024, View Source [SID1234642875]).

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"We started 2024 strong with compelling survival data from a pooled analysis of mature data for naporafenib plus trametinib in patients with NRAS-mutant (NRASm) melanoma, which showed a near doubling of median overall survival (mOS) versus comparable historical controls," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "These data also catalyzed an oversubscribed $45 million financing from new and existing high-quality investors. We are excited about the potential of this combination to improve both progression free survival and overall survival in patients with aggressive melanoma in need of additional treatment options."

Dr. Lim continued, "Throughout the year, we expect several data readouts across our clinical programs, including naporafenib (SEACRAFT-1), ERAS-007 (HERKULES-3), and ERAS-801 (THUNDERBBOLT-1). We also expect to initiate our pivotal SEACRAFT-2 trial evaluating naporafenib in the second quarter, with a randomized readout from Stage 1 of the Phase 3 trial anticipated in 2025. With our recent capital infusion and robust balance sheet, we believe that we have extended our cash runway into the second half of 2026 through multiple key inflection points."

Research and Development (R&D) Highlights

•
Analysis of mOS Data for Naporafenib: In March 2024, a pooled analysis of patients with NRASm melanoma dosed with the combination of naporafenib and trametinib (MEKINIST) at two different doses across two different trials (Phase 1b and Phase 2) showed a mOS of 13.0 and 14.1 months, respectively. The pooled dataset at each dose compares favorably relative to historical benchmarks.
•
Hosted an R&D Update Conference Call: In March 2024, Erasca provided updates on the Company’s lead clinical program, naporafenib, and its preclinical ERAS-4 program focused on the development of compounds targeting KRAS-mutant solid tumors.

Corporate Highlights

•
Extended Cash Runway with $45 Million Private Placement Financing: In March 2024, Erasca entered into an oversubscribed private placement led by high-quality new and existing healthcare-focused investors, which closed in April 2024 (2024 Private Placement), that extended its expected cash runway into the second half of 2026.
•
Entered into Two CTCSAs with Novartis for Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2: In February 2024, Erasca announced two clinical trial collaboration and supply agreements (CTCSAs) with Novartis pursuant to which Novartis will provide its MEK inhibitor trametinib at no cost to Erasca in connection with two clinical trials evaluating naporafenib in combination with trametinib for the treatment of patients with RAS Q61X solid tumors as part of the ongoing Phase 1b SEACRAFT-1 trial, and for the treatment of patients with previously treated NRASm unresectable or metastatic melanoma as part of the planned randomized pivotal Phase 3 SEACRAFT-2 trial.
Key Upcoming Milestones

•
SEACRAFT-1: Phase 1b trial for naporafenib (pan-RAF inhibitor) plus trametinib in patients with RAS Q61X tissue agnostic solid tumors
o
Initial Phase 1b combination data expected between the second and fourth quarters of 2024
•
SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRASm melanoma
o
Phase 3 trial initiation expected in the second quarter of 2024
o
Randomized readout from Stage 1 of the Phase 3 trial expected in 2025
•
HERKULES-3: Phase 1b trial for ERAS-007 (ERK inhibitor) plus encorafenib (BRAFTOVI) + cetuximab (ERBITUX) (EC) in EC-naïve patients with BRAF-mutant (BRAFm) colorectal cancer (CRC)
o
Phase 1b combination data expected in the second quarter of 2024
•
THUNDERBBOLT-1: Phase 1 trial for ERAS-801 (CNS-penetrant EGFR inhibitor) in patients with EGFR-amplified recurrent glioblastoma (GBM)
o
Initial Phase 1 monotherapy data expected in 2024

First Quarter 2024 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $297.7 million as of March 31, 2024, compared to $322.0 million as of December 31, 2023. Erasca expects its pro forma cash, cash equivalents, and marketable securities balance of $334 million (inclusive of the net proceeds received from the 2024 Private Placement) to fund operations into the second half of 2026.

Research and Development (R&D) Expenses: R&D expenses were $28.6 million for the quarter ended March 31, 2024, compared to $27.6 million for the quarter ended March 31, 2023. The increase was primarily driven by an increase in expenses incurred in connection with clinical trials, preclinical studies, and discovery activities, partially offset by a decrease in outsourced services and consulting fees.

General and Administrative (G&A) Expenses: G&A expenses were $10.3 million for the quarter ended March 31, 2024, compared to $9.4 million for the quarter ended March 31, 2023. The increase was primarily driven by increases in legal fees and personnel costs, including stock-based compensation expense.

Net Loss: Net loss was $35.0 million, or $(0.23) per basic and diluted share, for the quarter ended March 31, 2024, compared to $33.2 million, or $(0.22) per basic and diluted share, for the quarter ended March 31, 2023.

On May 8, 2024 Enveric Biosciences, Inc (NASDAQ: ENVB), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, reported that it has signed a non-binding term sheet with an undisclosed biotechnology development and commercialization company ("Licensee") to exclusively out-license two patent families of Methods for Treating Breast Cancer and Other Cancers for development through additional discovery and preclinical stages using cannabinoids in combination with chemotherapeutic drugs to treat cancer (Press release, Enveric Biosciences, MAY 8, 2024, View Source [SID1234642874]).

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In an historic move on Tuesday April 30, 2024, the Biden administration moved to reschedule marijuana, one source of cannabinoids, as a Schedule III controlled substance. The action followed study by the U.S. Department of Health and Human Services ("HHS"), recommendations by both HHS and the Department of Justice ("DOJ"), and support from the U.S. Drug Enforcement Agency ("DEA") that acknowledge the medical benefits of this class of drugs. Enveric applauds the move by the Biden administration which enjoys bi-partisan Congressional support and advances the development of medical uses of much needed drugs.

Under the terms of the agreement with Enveric, the Licensee will receive an exclusive, global license to the methods, and devices and drugs developed to practice the methods, which feature using cannabinoids in combination with chemotherapeutic drugs and will assume responsibility for all future preclinical and clinical development on a royalty-bearing basis for all human and animal pharmaceutical applications.

Assuming certain conditions are met, the Licensee will pay Enveric a License Execution Fee and development and sales milestones up to $61 Million, and royalties (ranging from 2.5% up to 10%) on all future sales. The Licensee also has a cash Buyout Option.

Based on preliminary work performed by a renowned UK-based research hospital, it is believed that the methods of using novel treatment regimens that include cannabinoids combinations have potentially a significant impact for patients living with breast and other cancers. It is anticipated that the Licensee may advance these methods into the next stages of development, and further into clinical trials which would demonstrate a major value driver for both Enveric and the Licensee.

"We are excited to see the Licensee taking this innovative approach in effort to advance a novel treatment based on our discovery," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "We look forward to partnering with the Licensee and are confident in their leadership to translate these discoveries into promising treatments for cancer patients. Importantly, this agreement further supports Enveric’s discovery capabilities and its ability to advance novel treatments for cancer and to make them available for others to pursue commercially outside the company with strong future potential upside to Enveric."

Breast Cancer alone has approximately 311,000 new cases diagnosed annually in the US, and over 4 million women have a history of, or are in treatment, for breast cancer in the US. The licensed methods also apply to many other forms of cancer that afflict millions more patients in the US.

On May 8, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, reported positive initial data from the ongoing CX-904 Phase 1a dose escalation clinical study, demonstrating a favorable safety profile and confirmed anti-cancer activity (Press release, CytomX Therapeutics, MAY 8, 2024, View Source [SID1234642873]). CX-904 is an investigational, masked, conditionally activated PROBODY T-cell engager designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment.

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"We are delighted to share these initial results today for CX-904, a highly innovative masked T-cell engager that embodies our vision at CytomX of transforming lives with safer, more effective therapies," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX. "These data build on more than a decade of innovation at CytomX, and, we believe, open broad new possibilities for T-cell engagers across many targets and cancer types. For EGFR specifically, a target that is present on normal epithelial tissues, we are very encouraged to see CX-904 working as designed by eliciting meaningful tumor reductions in a very difficult to treat tumor type and with a favorable overall safety profile. We look forward to continuing to explore the potential of this exciting agent in multiple EGFR positive cancers and to determining longer term strategy with our global development partner, Amgen."

As of the April 16, 2024 data cutoff, the Phase 1 study had enrolled 35 patients with advanced metastatic solid tumor types that are generally known to express EGFR, including pancreatic, colorectal (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastric, and esophageal cancers. Patients enrolled in the study were heavily pre-treated and had a median of 4 prior lines of therapy. As of the data cutoff, 19 patients were enrolled into initial non-step dosing cohorts with target doses ranging from 0.007 mg to 6 mg, and 16 patients were subsequently enrolled into step-dosing cohorts with target doses ranging from 5 mg to 10 mg and with tocilizumab prophylaxis. Enrollment into a cohort with a target dose of 15 mg is ongoing.

As of the cutoff date, CX-904 demonstrated a favorable safety profile that supports administration and monitoring of enrolled patients in an outpatient setting.1 There were no observed cases of CRS of any grade in step-dosing cohorts to-date. In non-step dosing cohorts, only Grade 1 CRS was observed in patients treated at the highest dose of 6 mg. Among all treated patients, the most common treatment-related adverse events (TRAEs) were rash, arthralgia, arthritis, pruritis, and vomiting, the majority of which were low grade, being observed in 14 (40%), 13 (37%), 5 (14%), 5 (14%) and 5 (14%) patients, respectively. Grade 3 TRAEs were tenosynovitis (n=1), arthralgia (n=2), arthritis (n=1), and rash (n=1).

Eight patients had measurable tumor reduction at data cutoff, including 2 of 6 efficacy-evaluable patients (33%) with pancreatic cancer with confirmed partial responses per RECIST 1.1. All 6 efficacy-evaluable patients with pancreatic cancer achieved disease control (objective response or stable disease). For the two patients with a confirmed partial response, one patient (6 mg target dose) achieved an 83% tumor reduction. The second patient (5 mg target dose) with a confirmed response achieved a 51% tumor reduction and remained on study treatment as of the data cutoff. In addition, a third pancreatic cancer patient maintained stable disease with no evidence of tumor growth through 3.5 months of study treatment and remained on treatment as of the data cutoff.

Preliminary pharmacokinetic and pharmacodynamic data were consistent with the PROBODY TCE mechanism of action, including maintained masking in circulation, and CD8+ T-cell margination and tumor infiltration.

CX-904 Phase 1a dose escalation and optimization continue, with future enrollment focused on determining a recommended Phase 2 dose, or doses. The Company expects to provide an additional Phase 1a dose escalation update by the end of 2024. These additional data will inform discussions with CytomX partner, Amgen, towards initiation of Phase 1b expansion cohorts in specific EGFR positive tumor types.

Conference Call & Webcast
CytomX management will host a conference call and simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) to discuss the first quarter 2024 results and provide an initial CX-904 Phase 1a clinical data update. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company’s website for at least 30 days.