On November 6, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported its third quarter 2024 results of operations (Press release, Gilead Sciences, NOV 6, 2024, View Source [SID1234647813]).

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"Gilead’s third quarter results are the strongest of the year to date, with 7% year-over-year revenue growth, including 13% year-over-year growth for Biktarvy. Based on this very strong topline growth and disciplined operating expense management, we are increasing our full year revenue, operating income, and earnings per share guidance," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. "We are excited to further increase our impact for patients and communities in the months ahead. This includes building on the momentum from the U.S. launch of Livdelzi for primary biliary cholangitis and preparing for the potential launch of the first twice-yearly option for HIV prevention option, lenacapavir."

Third Quarter 2024 Financial Results

•Total third quarter 2024 revenue increased 7% to $7.5 billion compared to the same period in 2023, primarily due to higher sales in HIV as well as in Veklury (remdesivir), Oncology and Liver Disease.

•Diluted earnings per share ("EPS") was $1.00 in the third quarter 2024 compared to $1.73 in the same period in 2023. The decrease was primarily driven by a pre-tax in-process research and development ("IPR&D") impairment of $1.75 billion, or $1.04 per share net of tax impact, related to assets acquired by Gilead from Immunomedics, Inc. ("Immunomedics") in 2020, as well as higher acquired IPR&D expense. This was partially offset by higher product sales and higher net unrealized gains on equity securities.
•Non-GAAP diluted EPS was $2.02 in the third quarter 2024 compared to $2.29 in the same period in 2023. The decrease was primarily driven by higher acquired IPR&D and tax expense, partially offset by higher product sales.
•As of September 30, 2024, Gilead had $5.0 billion of cash, cash equivalents and marketable debt securities compared to $8.4 billion as of December 31, 2023. The decrease primarily reflects the $3.9 billion acquisition of CymaBay Therapeutics, Inc.

•During the third quarter 2024 Gilead generated $4.3 billion in operating cash flow.
•During the third quarter 2024 Gilead paid dividends of $983 million and repurchased $300 million of common stock.

Third Quarter 2024 Product Sales

Total third quarter 2024 product sales increased 7% to $7.5 billion compared to the same period in 2023. Total third quarter 2024 product sales, excluding Veklury, increased 7% to $6.8 billion compared to the same period in 2023, primarily due to higher sales in HIV as well as in Oncology and Liver Disease.

HIV product sales increased 9% to $5.1 billion in the third quarter 2024 compared to the same period in 2023, driven by higher average realized price, primarily due to shifts in channel mix, and higher demand, partially offset by inventory dynamics.
•Biktarvy (bictegravir 50mg/emtricitabine 200mg ("FTC")/tenofovir alafenamide 25mg ("TAF")) sales increased 13% to $3.5 billion in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand and average realized price, partially offset by inventory dynamics.
•Descovy (FTC 200mg/TAF 25mg) sales increased 15% to $586 million in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand and average realized price, partially offset by inventory dynamics.
The Liver Disease portfolio sales increased 4% to $733 million in the third quarter 2024 compared to the same period in 2023. This was primarily driven by higher demand in viral hepatitis medicines, partially offset by unfavorable pricing dynamics.
Veklury sales increased 9% to $692 million in the third quarter 2024 compared to the same period in 2023, primarily driven by increased rates of COVID-19 related hospitalizations, particularly in the United States.
Cell Therapy product sales of $485 million in the third quarter 2024 were relatively flat compared to the same period in 2023.
•Yescarta (axicabtagene ciloleucel) sales decreased 1% to $387 million in the third quarter 2024 compared to the same period in 2023, reflecting increased in- and out-of-class competition in the United States, partially offset by increased demand in relapsed or refractory ("R/R") large B-cell lymphoma ("LBCL") in other regions.
•Tecartus (brexucabtagene autoleucel) sales increased 2% to $98 million in the third quarter 2024 compared to the same period in 2023, driven by increased demand in adult acute lymphoblastic leukemia ("ALL").
Trodelvy (sacituzumab govitecan-hziy) sales increased 17% to $332 million in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand across all regions.
Third Quarter 2024 Product Gross Margin, Operating Expenses and Effective Tax Rate
•Product gross margin was 79.1% in the third quarter 2024 compared to 77.6% in the same period in 2023. Non-GAAP product gross margin was 86.8% in the third quarter 2024 compared to 85.9% in the same period in 2023. The increases in GAAP and non-GAAP were primarily driven by product mix.
•Research & development ("R&D") expenses and non-GAAP R&D expenses were $1.4 billion in the third quarter 2024 compared to $1.5 billion in the same period in 2023. The decreases were primarily driven by the timing of clinical activities, including the wind-down of the magrolimab and obeldesivir COVID programs.
•Acquired IPR&D expenses were $505 million in the third quarter 2024, primarily driven by a $320 million charge related to the buy-out of global Livdelzi (seladelpar) royalties from Janssen Pharmaceutica NV, as well as payments related to ongoing collaborations.
•IPR&D impairment was $1.75 billion related to the assets acquired from Immunomedics in 2020 with no similar charges in 2023.
•Selling, general and administrative ("SG&A") expenses and non-GAAP SG&A expenses were $1.4 billion in the third quarter 2024 compared to $1.3 billion in the same period in 2023. The increases reflect the timing of commercial activities, including the launch of Livdelzi in the United States, and other corporate activities.

•The effective tax rate ("ETR") was (31.1)% in the third quarter 2024 compared to 6.3% in the same period in 2023. The decrease in ETR primarily reflects the impact of a legal entity restructuring and the aforementioned Immunomedics IPR&D impairment expense, partially offset by a prior year decrease in tax reserves that did not repeat. Non-GAAP ETR was 17.5% in the third quarter 2024 compared to 7.0% in the same period in 2023, primarily reflecting the impact of the prior year decrease in tax reserves.
Guidance and Outlook
For the full-year 2024, Gilead expects:
(in millions, except per share amounts)
November 6, 2024 Guidance
Low End High End Comparison to August 8, 2024 Guidance
Product sales $ 27,800 $ 28,100
Previously $27,100 to $27,500
Product sales, excluding Veklury $ 26,000 $ 26,300
Previously $25,800 to $26,200
Veklury $ 1,800 $ 1,800 Previously $1,300
Diluted EPS $ 0.05 $ 0.25
Previously $0.00 to $0.30
Non-GAAP diluted EPS $ 4.25 $ 4.45
Previously $3.60 to $3.90

Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2024 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below.
Key Updates Since Our Last Quarterly Release
Virology
•Announced results of PURPOSE 2, the second Phase 3 study of twice-yearly lenacapavir for HIV prevention, with data presented at the HIV Research for Prevention Conference. In the lenacapavir group, 99.9% of participants did not acquire HIV infection, with 2 incident cases among 2,179 participants. Lenacapavir reduced HIV infections by 96% compared to background HIV incidence in cisgender men and gender-diverse people, and additionally demonstrated superiority to daily Truvada (FTC 200mg and tenofovir disoproxil fumarate 300mg; 89% relative risk reduction). Lenacapavir was generally well-tolerated and no significant or new safety concerns were identified. Gilead expects to file for U.S. Food and Drug Administration ("FDA") approval before the end of the year, with global filings to follow. The use of lenacapavir for the prevention of HIV is investigational.
•Presented HIV treatment data at the Infection Disease Week ("IDWeek") meeting, including Week 48 data from the Phase 2 study evaluating the investigational oral once-weekly combination regimen of lenacapavir with Merck’s, known as MSD outside of the United States and Canada ("Merck"), islatravir. In addition, Phase 1a data of the investigational once-weekly GS-1720 and 3-year follow up from the Phase 2/3 CAPELLA trial of twice-yearly lenacapavir in people with multi-drug resistant HIV were also highlighted.
•Signed royalty-free voluntary licensing agreements with six manufacturers to make and sell generic lenacapavir for HIV prevention and for HIV treatment in heavily treatment-experienced adults with multi-drug resistant HIV in 120 high-incidence, resource-limited countries, subject to regulatory approval of lenacapavir in those markets.
•Presented data at IDWeek from the Phase 3 BIRCH and OAKTREE trials of investigational obeldesivir in non-hospitalized participants at high-risk or standard-risk for severe COVID-19, respectively. Previously, Gilead announced the early termination of the BIRCH trial and top-line results from the OAKTREE trial which found that while the study did not meet its primary endpoint, obeldesivir was found to have a generally well tolerated safety profile. The detailed data presented add to the breadth of safety data on obeldesivir.

•Donated approximately 5,000 vials of remdesivir to the Rwanda Medical Supply in response to the Marburg Virus Disease ("MVD") outbreak for emergency use. Remdesivir is not approved for the treatment of MVD anywhere globally, and the safety and efficacy of this use is not known.
Oncology
•Announced abstracts for the American Society of Hematology (ASH) (Free ASH Whitepaper) 2024 Annual Meeting ("ASH"), including preliminary data from the registrational Phase 2 iMMagine-1 trial evaluating the Arcellx, Inc. ("Arcellx") partnered investigational CAR T anito-cel (anitocabtagene autoleucel) in R/R multiple myeloma, as well as updated results from the Phase 1 trial. Additionally, the first patient has been dosed in the Phase 3 iMMagine-3 trial in 2L+ R/R multiple myeloma.
•Announced ASH (Free ASH Whitepaper) abstracts for long-term follow-up of Yescarta in R/R indolent non-Hodgkin’s lymphoma and Tecartus in R/R mantle cell lymphoma, as well as real world data for Tecartus in B-cell precursor ALL.
•Presented Trodelvy data at the International Association for the Study of Lung Cancer World Conference on Lung Cancer across first- and second-line advanced or metastatic non-small cell lung cancer, as well as in extensive-stage small cell lung cancer. The use of Trodelvy for lung cancer is investigational.
•Announced plans to voluntarily withdraw the U.S. accelerated approval of Trodelvy for use in pre-treated adult patients with locally advanced or metastatic urothelial cancer, following the results of the Phase 3 TROPiCS-04 trial announced in May 2024.
•Received FDA Regenerative Medicine Advanced Therapy Designation for the evaluation of Yescarta as first-line treatment for adult patients with newly diagnosed, high-risk LBCL, an investigational use.
Inflammation
•Received FDA accelerated approval for Livdelzi for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid ("UDCA") in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.
Corporate
•Announced a strategic collaboration with Genesis Therapeutics, Inc. ("Genesis") to discover and develop novel small molecule therapies across multiple targets using Genesis’ GEMS AI platform.
•The Board declared a quarterly dividend of $0.77 per share of common stock for the fourth quarter of 2024. The dividend is payable on December 30, 2024, to stockholders of record at the close of business on December 13, 2024. Future dividends will be subject to Board approval.
Certain amounts and percentages in this press release may not sum or recalculate due to rounding.
Conference Call
At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on View Source and will be archived on www.gilead.com for one year.

On November 6, 2024 Genmab reported Interim results for the First Nine Months Ended September 30, 2024 (Press release, Genmab, NOV 6, 2024, View Source [SID1234647812]).

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Highlights

● European Commission (EC) granted conditional marketing authorization for TEPKINLY (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
● Genmab announced that it will assume sole responsibility for the continued development and potential commercialization of acasunlimab
● Genmab revenue increased 29% compared to the first nine months of 2023, to DKK 15,085 million
● Genmab 2024 financial guidance updated

"The third quarter of 2024 presented Genmab with additional opportunities to progress towards our goal of fundamentally transforming the lives of people with cancer and other serious diseases. The additional approval for TEPKINLY, along with positive data presentations for our promising late-stage assets acasunlimab and rinatabart sesutecan (Rina-S), underscore the potential of our pipeline and our commitment to the development of innovative antibody-based therapeutics," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Nine Months of 2024

● Revenue was DKK 15,085 million for the first nine months of 2024 compared to DKK 11,715 million for the first nine months of 2023. The increase of DKK 3,370 million, or 29%, was primarily driven by higher DARZALEX (daratumumab) and Kesimpta (ofatumumab) royalties achieved under our collaborations with Janssen Biotech, Inc. (Janssen) and Novartis Pharma AG (Novartis), respectively, and increased EPKINLY (epcoritamab) net product sales.
● Royalty revenue was DKK 12,367 million in the first nine months of 2024 compared to DKK 9,722 million in the first nine months of 2023, an increase of DKK 2,645 million, or 27%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
● Net sales of DARZALEX, including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), by Janssen were USD 8,586 million in the first nine months of 2024 compared to USD 7,194 million in the first nine months of 2023, an increase of USD 1,392 million or 19%.
● Total costs and operating expenses were DKK 10,542 million in the first nine months of 2024 compared to DKK 8,145 million in the first nine months of 2023. The increase of DKK 2,397 million, or 29%, was driven by the expansion of our product pipeline, including the addition of ProfoundBio related research and development expenses, primarily Rina-S, the continued development of Genmab’s broader organizational capabilities and related increase in team members to support these activities, as well as profit-sharing amounts payable to AbbVie Inc. (AbbVie) related to EPKINLY sales.
● Operating profit was DKK 4,543 million in the first nine months of 2024 compared to DKK 3,570 million in the first nine months of 2023.
● Net financial items resulted in income of DKK 1,019 million for the first nine months of 2024 compared to DKK 1,060 million in the first nine months of 2023.

Genmab Announces Financial Results for the First Nine Months of 2024

Outlook

Genmab is updating the lower end of its revenue range of 2024 financial guidance driven by higher total royalty revenues from DARZALEX. Genmab is also lowering the upper end of its operating expense range to reflect a continued focused and disciplined approach to investments and portfolio prioritization.

(DKK million)

Revised Guidance

Previous Guidance

Revenue

21,100 – 21,700

20,500 – 21,700

Royalties

17,000 – 17,400

16,600 – 17,400

Net product sales/Collaboration revenue*

2,000 – 2,200

2,000 – 2,200

Milestones/Reimbursement revenue

2,100 – 2,100

1,900 – 2,100

Gross profit**

20,200 – 20,800

19,600 – 20,800

Operating expenses**

(13,700) – (14,000)

(13,700) – (14,300)

Including Acquisition & Integration Related Charges

(14,100) – (14,400)

(14,100) – (14,700)

Operating profit

6,200 – 7,100

5,300 – 7,100

Including Acquisition & Integration Related Charges

5,800 – 6,700

4,900 – 6,700

*Net Product Sales and Collaboration Revenue consists of EPKINLY Net Product Sales in the U.S. and Japan and Tivdak (Genmab’s share of net profits) in the U.S.

**Operating Expenses Range excludes Cost of Product Sales Range, which is included in Gross Profit Range

Conference Call

Genmab will hold a conference call to discuss the results for the first nine of 2024 today, November 6, 2024, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: https://register.vevent.com/register/BI6db06ed786914762a9dc001f798b7c1b. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations.

On November 6, 2024 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for cancer based on its unique Mimicry platform, reported that clinical data from the ongoing Phase 1/2 ‘SIDNEY’ trial of EO2463, an experimental treatment for indolent non-Hodgkin B-cell lymphoma (iNHL), will be presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Conference, to take place December 7-10, 2024, in San Diego, California, and online (Press release, Enterome, NOV 6, 2024, View Source [SID1234647810]).

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These presentations will disclose the first data from Phase 2 Cohort 2, evaluating EO2463 as monotherapy for newly diagnosed patients with asymptomatic follicular lymphoma, where EO2463 may offer a safe, proactive immune therapy alternative to the usual "watch-and-wait" observation strategy. The data also report initial findings on a biomarker with potential to predict long-term response to EO2463, both as monotherapy, and in combination with standard treatments, in relapsed/refractory iNHL.

Details of the poster presentations:

Abstract #1616

Title: EO2463 Peptide Immunotherapy in Patients with Indolent NHL: A Phase 1 Exploration of a Response Biomarker for EO2463 Monotherapy and EO2463 in Combination with Lenalidomide/Rituximab
Presenting Author: J.C. C. Villasboas Bisneto, M.D., Mayo Clinic
Session: 622. Lymphomas: Translational – Non-Genetic: Poster I
Session Date: Saturday, December 7, 2024
Presentation Time: 5:30 PM – 7:30 PM
Abstract #4395

Title: EO2463 Peptide Immunotherapy in Patients with Newly Diagnosed Asymptomatic Follicular Lymphoma Results in Monotherapy Objective Clinical Responses Linked with Anti-Peptide Specific CD8 Memory T Cell Responses: The EONHL1-20/SIDNEY Study
Presenting Author: Stephen Smith, M.D., Associate Professor, UW Medicine & Fred Hutchinson Cancer Center
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
Session Date: Monday, December 9, 2024
Presentation Time: 6:00 PM – 8:00 PM
SIDNEY (EONHL1-20) is a Phase 1/2 multicenter, open-label, first-in-human study of EO2463 as a monotherapy and in combination with lenalidomide and/or rituximab for the treatment of patients with iNHL. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in approximately 60 patients with follicular lymphoma (FL) and marginal zone lymphoma (MZL).

For more information on the study, visit www.Clinicaltrials.gov, reference: NCT04669171.

About EO2463:

EO2463 is an innovative, off-the-shelf immunotherapy candidate that combines four synthetic OncoMimic peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). EO2463 also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2).

The unique ability of EO2463 immunotherapy to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes that are abundant in iNHL. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms.

On November 6, 2024 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported financial results for the third quarter ended September 30, 2024, and highlighted recent business achievements (Press release, Elevation Oncology, NOV 6, 2024, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-third-quarter-2024-financial-results-and-highlights-recent-business-achievements [SID1234647809]).

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"We continue to make significant progress with EO-3021, our potentially best-in-class Claudin 18.2 antibody-drug conjugate (ADC). Based on the favorable initial clinical data reported in August, we are advancing EO-3021 in both the monotherapy and combination settings across early and later lines of therapy for patients with Claudin 18.2-expressing gastric or GEJ cancer," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "In the past quarter, we initiated the dose expansion portion of the Phase 1 trial of monotherapy EO-3021 and we look forward to reporting additional data in the first half of 2025."

Mr. Ferra continued, "We are encouraged by the promising preliminary efficacy and differentiated safety profile seen in the dose escalation portion of our Phase 1 trial. The favorable initial data highlights EO-3021’s unique potential as a more combinable Claudin 18.2 ADC with competitive anti-tumor activity. We are well-positioned to explore the full promise of EO-3021 including its better combinability, and are initiating the combination portion of our Phase 1 trial in Q4 2024. Additionally, we look forward to sharing preclinical data at ESMO (Free ESMO Whitepaper)-IO 2024 in December that further reinforce our combination strategy with VEGFR2 or PD-1 inhibitors. Together with our ongoing monotherapy efforts, this reflects a robust, broad clinical development plan that will allow us to evaluate EO-3021 across the first, second and later lines of therapy. We remain focused on generating meaningful data and executing toward our goal of bringing important treatment options to patients with significant unmet medical needs."

Recent Business Achievements

In September 2024, Elevation Oncology announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation (FTD) to EO-3021 for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy. Fast Track is a process designed by the FDA to facilitate the development and expedite the review of therapeutic candidates intended to treat serious or life-threatening conditions, for which nonclinical or clinical data demonstrate the potential to address unmet medical needs. Therapeutic candidates that receive FTD may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan. Therapeutic candidates with FTD may also be eligible for priority review and accelerated approval if supported by clinical data.
In August 2024, Elevation Oncology announced promising initial clinical data from the dose escalation portion of the ongoing Phase 1 clinical trial of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, GEJ, pancreatic or esophageal cancers. As of the data cutoff date of June 10, 2024:
In seven patients with Claudin 18.2 in ≥20% of tumor cells at IHC 2+/3+:
Objective response rate (ORR) was 42.8% (three confirmed partial responses, one of which was confirmed following the June 10, 2024 data cutoff).
Disease control rate (DCR) was 71.4%, including two patients with stable disease.
EO-3021 was observed to be generally well-tolerated:
Minimal hematological toxicity or hepatotoxicity, and no peripheral neuropathy/hypoesthesia was observed in the safety population of 32 patients treated with EO-3021.
Initial safety data suggests minimal payload-associated toxicity and limited overlapping toxicity with standard-of-care agents including PD-1 inhibitors and chemotherapies.
Expected Upcoming Milestones

EO-3021:

Present preclinical data on the combination potential of EO-3021 with VEGFR2 or PD-1 inhibitors at ESMO (Free ESMO Whitepaper)-IO 2024 in December 2024.
Initiate dosing in combination portion of the ongoing Phase 1 clinical trial of EO-3021 in the fourth quarter of 2024; combination cohorts will explore EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, in the second-line setting and in combination with dostarlimab, a PD-1 inhibitor, in the front-line setting.
Report additional data from the ongoing Phase 1 clinical trial of monotherapy EO-3021, including from the dose expansion cohort, in the first half of 2025.
HER3-ADC:

Nominate development candidate for HER3-ADC program in the fourth quarter of 2024.
Third Quarter 2024 Financial Results

As of September 30, 2024, Elevation Oncology had cash, cash equivalents and marketable securities totaling $103.1 million, compared to $83.1 million as of December 31, 2023. The increase in cash reflects net proceeds of $44.2 million, which Elevation Oncology raised through its at-the-market (ATM) facility in the first half of 2024, partially offset by cash used to fund operating activities.

Research and development (R&D) expenses for the third quarter of 2024 were $9.4 million, compared to $7.4 million for the third quarter of 2023. The increase in R&D expenses was driven by continuous investment in the Company’s lead and pipeline programs.

General and administrative (G&A) expenses for the third quarter of 2024 were $3.8 million, compared to $3.5 million for the third quarter of 2023. The increase in G&A expenses in the third quarter of 2024 was primarily due to increased personnel costs, including stock-based compensation.

Net loss for the third quarter of 2024 was $12.9 million, compared to $10.6 million for the third quarter of 2023.

Financial Outlook

Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of September 30, 2024 to be sufficient to fund its current operations into 2026.

About EO-3021

EO-3021 is a differentiated, clinical-stage, potentially best-in-class, antibody-drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and a monomethyl auristatin E (MMAE) payload with a cleavable linker that is site-specifically conjugated to Glutamine 295 providing a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformation, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in the dose expansion portion of a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic gastric/gastroesophageal adenocarcinoma that express Claudin 18.2. Following recently signed clinical supply agreements with Lilly and GSK, respectively, Elevation Oncology will evaluate EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, in second-line patients and in combination with dostarlimab, a PD-1 inhibitor, in the front-line setting.

In September 2024, EO-3021 was granted Fast Track designation by the FDA for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy. EO-3021 was granted orphan drug designation by the FDA for the treatment of gastric cancer (including cancer of gastroesophageal junction) in November 2020 and for the treatment of pancreatic cancer in May 2021.

Elevation Oncology has the exclusive rights to develop and commercialize EO-3021 in all global territories outside Greater China.

On November 6, 2024 Coherus BioSciences, Inc. (Coherus or the Company, Nasdaq: CHRS), reported financial results for the quarter ended September 30, 2024 and recent business highlights (Press release, Coherus Biosciences, NOV 6, 2024, View Source [SID1234647808]):

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"Revenue growth was strong in the third quarter, with the UDENYCA franchise increasing 30% compared to the second quarter, and 100% over Q3 2023. LOQTORZI sales grew more than 50% compared to the second quarter of 2024," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "Our sharpened focus on oncology is delivering results. Third quarter 2024 revenues are now comparable to Q3 2023, despite our divestitures, with higher gross profit, lower operating expenses and lower interest expense."

"We continue to make progress towards our long-term vision of bringing innovative, next-generation therapies to extend cancer patient survival. Our competitively positioned pipeline, in combination with LOQTORZI, is advancing to plan in tumor types with high unmet medical need and with robust supportive biology," continued Mr. Lanfear.

RECENT BUSINESS HIGHLIGHTS

UDENYCA RESULTS

● UDENYCA net product sales were $66.1 million in Q3 2024, an increase of 30% compared to $50.9 million in Q2 2024 and a 100% increase compared to $33.0 million in Q3 2023.
● Q3 revenue was driven by a 54% increase in demand for ONBODY and a higher overall net selling price.
● In Q3, UDENYCA maintained its #2 position in the pegfilgrastim class with 28% market share.

UDENYCA SUPPLY UPDATE

● Coherus’ third-party labeling and packaging contract manufacturing organization (CMO) for UDENYCA has informed the Company that production will resume this week, a few weeks later than previously targeted and disclosed. Based on the production schedule, the backlog of UDENYCA lots of approximately 120,000 units will be completed without further interruption or delay by the end of the year.
● The Company has also made significant progress in its previously announced efforts to diversify its labeling and packaging resources. An additional final packaging and labeling CMO has already started production testing and is expected to start manufacturing saleable product by the end of 2024. Commercial supply from that CMO is expected to commence in the first quarter of 2025, subject to U.S. Food and Drug Administration (FDA) authorization. Once the second facility is commercially operational, the Company projects that its labeling and packaging capacity will have doubled to over one million UDENYCA units annually, consistent with the rest of its supply chain.

LOQTORZI LAUNCH UPDATE

● LOQTORZI, the first and only FDA-approved treatment for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), commercially launched across all lines of therapy on January 2, 2024.
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● LOQTORZI net product sales were $5.8 million in Q3 2024, an increase of 54% compared to $3.8 million in Q2 2024.
● The number of LOQTORZI treated patients grew by more than 60% in Q3, with new patient uptake primarily in relapsed locally advanced and 1L metastatic disease, the key driver of long-term revenue growth.
● Since launch, nearly 80% of all National Comprehensive Cancer Network (NCCN) institutions have written prescriptions for at least one new patient.

ADVANCEMENT OF PROMISING IMMUNO-ONCOLOGY PIPELINE

● This quarter, the Company expects to open a Phase 2 randomized study evaluating casdozokitug, an immune regulatory IL-27 antagonist in combination with toripalimab and bevacizumab for the treatment of unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) in treatment-naive patients.
● The Company also anticipates final data from its Phase 2 trial of casdozokitug combined with atezolizumab and bevacizumab in first-line HCC in the first quarter of 2025. Coherus has received FDA orphan drug status and fast track designation for casdozokitug in HCC.
● A Phase 1 study evaluating CHS-114, a highly selective cytolytic anti-CCR8 antibody, is ongoing. In the first half of 2025, Coherus expects to report Phase 1 data from expansion cohorts evaluating CHS-114 as monotherapy and in combination with toripalimab in patients with advanced/metastatic head and neck squamous cell carcinoma (HNSCC).
● Coherus plans to initiate Phase 1b dose optimization studies of CHS-114 in combination with toripalimab in patients with HNSCC and gastric cancer in the first quarter of 2025, with initial data for both studies expected in the first half of 2026.

THIRD QUARTER 2024 FINANCIAL RESULTS

Net revenue was $70.8 million during the three months ended September 30, 2024, and included $66.1 million of net sales of UDENYCA and $5.8 million of net sales of LOQTORZI. Net revenue was $74.6 million during the three months ended September 30, 2023 and included $33.0 million in net sales of UDENYCA and $41.4 million attributable to the Company’s divested products, CIMERLI and YUSIMRY.

Net revenue was $212.8 million and $165.7 million for the nine months ended September 30, 2024 and 2023, respectively. Total net revenue attributable to the Company’s divested products, CIMERLI and YUSIMRY, during the first nine months of 2024 and 2023 was $34.5 million and $74.3 million, respectively. In addition, the first nine months of 2024 included other revenue of $7.0 million mainly comprising the $6.3 million up-front cash payment received for the outlicense to Apotex, Inc. of the Canadian rights to LOQTORZI on June 27, 2024.

Cost of goods sold (COGS) was $20.7 million and $32.7 million during the three months ended September 30, 2024 and 2023, respectively, and $83.7 million and $74.4 million during the nine months ended September 30, 2024 and 2023, respectively. The decrease in COGS for the third quarter of 2024 compared to the same period in the prior year was primarily due to $24.1 million of COGS in the third quarter of 2023 related to CIMERLI and YUSIMRY, which were divested during the first half of 2024, partially offset by a $9.7 million increase in product costs driven by increased UDENYCA volume.

The increase in COGS for the nine months ended September 30, 2024 compared to the same period in the prior year was primarily due to a $27.8 million increase related to volumes driven by UDENYCA and LOQTORZI, $4.5 million in connection with a CMO contract change, and $2.5 million in LOQTORZI royalties. These increases were partially offset by non-recurring COGS related to products divested during the first half of 2024 mentioned above.

Research and development (R&D) expenses were $21.7 million and $25.6 million for the three months ended September 30, 2024 and 2023, respectively, and $72.1 million and $83.1 million for the nine months ended September 30, 2024 and 2023, respectively. The decreases were primarily due to savings from reduced headcount and lower costs related to biosimilar product divestitures, partially offset by costs for development of casdozokitug and CHS-114.

Selling, general and administrative (SG&A) expenses were $34.7 million and $48.2 million during the three months ended September 30, 2024 and 2023, respectively, and $126.4 million and $142.5 million during the nine months ended September 30, 2024 and 2023, respectively. The declines in SG&A compared to the prior year periods were driven primarily by lower headcount. The decrease for the nine-month period was partially offset by the net $6.8 million charge in the first quarter of 2024 associated with the full write-off of the outlicense intangible asset and associated release of the CVR liability related to NZV930, obtained in the Surface Oncology, Inc. acquisition.

Interest expense was $5.4 million and $10.3 million during the three months ended September 30, 2024 and 2023, respectively, and $21.8 million and $29.9 million during the nine months ended September 30, 2024 and 2023, respectively. The declines in both periods were primarily due to prepaying $175.0 million of the principal amount due under the 2027 Term Loans on April 1, 2024 and the remaining $75.0 million principal amount on May 8, 2024, partially offset by interest on the senior secured term loan facility of up to $38.7 million and the revenue participation right purchase and sale agreement, both commencing May 8, 2024.

Gain on sale transactions, net was $176.6 million for the nine months ended September 30, 2024 and included a $153.8 million gain on the divestiture of our CIMERLI ophthalmology franchise, which closed during the first quarter of 2024, and a $22.9 million gain on the divestiture of our YUSIMRY immunology franchise, which closed during the second quarter of 2024. There was no gain on sale transactions in the nine months ended September 30, 2023.

Net loss for the third quarter of 2024 was $10.8 million, or $(0.09) per share on a diluted basis, compared to a net loss of $39.6 million, or $(0.41) per share on a diluted basis for the same period in 2023. Net income for the nine months ended September 30, 2024 was $79.2 million, or $0.65 per share on a diluted basis, compared to a net loss of $158.2 million, or $(1.79) per share on a diluted basis for nine months ended September 30, 2023.