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Genmab Announces Financial Results for the First Nine Months of 2023

On November 7, 2023 Genmab reported Interim Results for the First Nine Months Ended September 30, 2023 (Press release, Genmab, NOV 7, 2023, View Source [SID1234637137]).

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Highlights

Epcoritamab (TEPKINLY) was granted conditional marketing authorization by the European Commission (EC) to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
Epcoritamab (EPKINLY) was approved by the Japan Ministry of Health, Labour and Welfare to treat adults with certain types of relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy
Genmab and Seagen Inc. (Seagen) announced that the Phase 3 innovaTV 301 confirmatory trial of tisotumab vedotin for the treatment of recurrent or metastatic cervical cancer met its primary endpoint of improved overall survival (OS) at a predetermined, independent interim analysis
Genmab revenue increased 26% compared to the first nine months of 2022, to DKK 11,796 million
Genmab 2023 financial guidance updated
"With regulatory approvals in Japan and Europe, EPKINLY/TEPKINLY is the first Genmab-owned medicine to become available to patients outside of the United States. In addition to being an important milestone for Genmab, these approvals mark an important milestone for patients in these territories who are in need of alternative therapeutic options," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to continue to work with our partner, AbbVie Inc. (AbbVie), to further explore epcoritamab as a potential future core therapy across B-cell malignancies."

Financial Performance First Nine Months of 2023

Net sales of DARZALEX by Janssen Biotech, Inc. (Janssen) were USD 7,194 million in the first nine months of 2023 compared to USD 5,894 million in the first nine months of 2022, an increase of USD 1,300 million, or 22%.
Royalty revenue was DKK 9,803 million in the first nine months of 2023 compared to DKK 8,207 million in the first nine months of 2022, an increase of DKK 1,596 million, or 19%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta, partly offset by negative foreign exchange rate impacts due to a lower average exchange rate between the USD and DKK.
Revenue was DKK 11,796 million for the first nine months of 2023 compared to DKK 9,368 million for the first nine months of 2022. The increase of DKK 2,428 million, or 26%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Janssen and Novartis Pharma AG (Novartis), respectively, a milestone achieved under our collaboration with AbbVie for the first commercial sale of EPKINLY in the United States, and higher reimbursement revenue driven by increased activities under our collaboration with BioNTech SE (BioNTech).
Operating expenses were DKK 8,045 million in the first nine months of 2023 compared to DKK 5,676 million in the first nine months of 2022. The increase of DKK 2,369 million, or 42%, was driven by the expansion of our product pipeline, EPKINLY launch in the U.S., the continued development of Genmab’s broader organizational capabilities, and related increase in team members to support these activities.
Operating profit was DKK 3,651 million in the first nine months of 2023 compared to DKK 3,692 million in the first nine months of 2022.
Net financial items resulted in income of DKK 1,060 million for the first nine months of 2023 compared to DKK 2,681 million in the first nine months of 2022. The decrease of DKK 1,621 million, or 60%, was primarily driven by movements in USD to DKK foreign exchange rates impacting Genmab’s USD denominated cash and cash equivalents, and marketable securities in the respective periods.
Outlook
Genmab is updating the lower end of its revenue and operating expenses of its 2023 financial guidance driven by higher total royalty revenues from DARZALEX and other marketed products and increased and accelerated investment for epcoritamab clinical trials and progression of other pipeline products.

Revised Previous
(DKK million) Guidance Guidance
Revenue 15,900 – 16,500 15,500 – 16,500
Operating expenses (10,600) – (10,900) (10,400) – (10,900)
Operating profit* 4,800 – 5,750 4,500 – 6,000
*Operating profit includes DKK~0.2 billion of cost of product sales, which is not classified within operating expenses

Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2023 today, Tuesday, November 7, 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/BIa45c5d7cd5384835a879e0ab083d0577. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

Fusion Pharmaceuticals Announces Third Quarter 2023 Financial Results and
Clinical Program Updates

On November 7, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the third quarter ended September 30, 2023 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, NOV 7, 2023, View Source [SID1234637136]).

Chief Executive Officer John Valliant, Ph.D., commented, "In 2023, Fusion has focused on transitioning to a later stage company leading the development of next-generation radiopharmaceuticals that leverage the potency and precision of alpha-emitting particles. We believe in the potential of our diversified pipeline of targeted alpha therapy (TAT) programs, our AstraZeneca collaboration, multiple actinium supply partnerships and our proprietary, state-of-the-art radiopharmaceutical manufacturing facility to produce innovative therapies for patients with multiple cancer types and create significant value.

Dr. Valliant continued, "In the third quarter, we advanced patient enrollment in our Phase 2 clinical trial of FPI-2265, a small molecule-based TAT targeting prostate specific membrane antigen (PSMA) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) which is positioned to be the first actinium-based PSMA TAT to market. We are on track to report data on approximately 20 to 30 patients in the first quarter of 2024. Following encouraging recently reported data and continued momentum in the PSMA-targeted radiopharmaceuticals space, we are increasingly excited about the substantial market and patient need that FPI-2265 could address. We are also on track to share data from the second cohort in our Phase 1 study of FPI-1434 in patients with solid tumors expressing IGF-1R around the end of this year. In addition, we were pleased to share preclinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on FPI-2068, a jointly developed TAT with AstraZeneca targeting solid tumors expressing EGFR-cMET, which showed anti-tumor efficacy and confirmatory evidence of FPI-2068’s mechanism of action. These data were the basis for our investigational new drug (IND) clearance earlier this year, and we look forward to progressing the program into the previously announced Phase 1 clinical study.

"Finally, with manufacturing and supply chain expertise as a core foundation of Fusion, we are pleased with the progress in validation of our proprietary GMP radiopharmaceutical manufacturing facility, which we expect will be capable of producing up to 100,000 doses of drug per year. We look forward to beginning to produce clinical doses early in 2024 and are confident in the diversified supply chain we have invested in which supports our ability to deliver therapies to patients in need."

Portfolio Update

FPI-2265

In February 2023, Fusion acquired an IND for an ongoing Phase 2 clinical trial (the "TATCIST" trial) evaluating 225Ac-PSMA I&T, a small molecule targeting PSMA expressed on prostate cancers. The alpha-emitting radiopharmaceutical being evaluated in the TATCIST trial is now known as FPI-2265.

The TATCIST trial is designed to evaluate patients with mCRPC with progressive disease, including patients who are naïve to PSMA-targeted radiopharmaceuticals and those who have been pre-treated with 177Lu-based PSMA radiopharmaceuticals such as PLUVICTO. Fusion expects to report data on approximately 20 to 30 patients in the first quarter of 2024 including safety and efficacy results (PSA50 responses, ORR, and rPFS).

FPI-1434

The Phase 1, multi-center, open-label clinical trial is designed to investigate the safety, tolerability, and pharmacokinetics of FPI-1434 in patients with solid tumors expressing IGF-1R. The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose. Interim Phase 1 data were presented at the SNMMI Annual Meeting in June 2023. Three patients were dosed in Cohort 1 at a dose of 15 kBq/kg following pre-administration of cold antibody. In this first cohort, cold/hot dosing was observed to be safe with no treatment-related serious adverse events (SAEs) or dose limiting toxicities (DLTs). Results demonstrated pre-administration of cold antibody improved tumor uptake while also reducing hematological toxicity observed in the hot only dosing arm, potentially enhancing the therapeutic index. When normalized to 15 kBq/kg, the average lesion absorbed dose and dose/volume in the cold/hot arm were nearly double the level compared to hot only. Further, the 15 kBq/kg cold/hot dosing arm showed comparable systemic exposure to approximately 40 kBq/kg of a hot only dose but with an improved hematological profile as measured by changes in platelet count.

Fusion is currently enrolling Cohort 2 in the cold/hot dosing regimen at 25 kBq/kg. The Company expects to report data from this cohort around year-end 2023.

FPI-2059

The Phase 1, multi-center, open-label clinical trial is designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-2059 as well as preliminary anti-tumor activity in participants with NTSR1 expressing advanced metastatic solid tumors. Patient enrollment and dosing are ongoing. Fusion plans to provide guidance on timing for pharmacokinetic, imaging and safety data following early experience with FPI-2059 patient screening and enrollment.

FPI-2068

Fusion announced FDA clearance of IND applications for [225Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [111In]-FPI-2107 (FPI-2107). Fusion is jointly developing FPI-2068 with AstraZeneca under the companies’ multi-asset collaboration agreement. FPI-2068 is a bispecific IgG-based TAT designed to deliver actinium-225 to various solid tumors that express EGFR and cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.

FENNEC PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

On November 7, 2023 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, reported its financial results for the third quarter ended September 30, 2023 and provided a business update (Press release, Fennec Pharmaceuticals, NOV 7, 2023, View Source [SID1234637135]).

"We continued to see strong commercial performance with PEDMARK in the third quarter demonstrated by net product revenue of $6.5 million representing 96% quarter over quarter growth. PEDMARK addresses a significant unmet medical need in the pediatric oncology community, and we expect to continue building upon our commercial momentum through expanding the prescriber base and increasing the utilization of the earlier endorsement from the NCCN for PEDMARK in the adolescent and young adult (AYA) population," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. "Further, we are pleased with the steady progress that we are making preparing for the launch of PEDMARQSI in Europe, including the recent regulatory approval in the U.K. by the MHRA, as we continue to evaluate the best commercial pathway for the Company in Europe."

Financial Results for the third Quarter 2023

· Net Sales – The company recorded net product sales of $6.5 million in the third quarter of 2023 compared to net product sales of $3.3 million in the second quarter of 2023. The Company had gross profit of $6.2 million for the third quarter of 2023. The increase in sales reflects strong growth in new patient starts and account adoption.

· Cash Position – Cash and cash equivalents were $12.4 million on September 30, 2023. The decrease in cash and cash equivalents between September 30, 2023, and December 31, 2022, is the result of cash outlays for operating expenses related to the promotion and marketing of PEDMARK and general and administrative expenses, which were offset by cash inflows primarily from product sales. We anticipate that our cash, cash equivalents and investment securities as of September 30, 2023, when coupled with PEDMARK revenue assumptions will be sufficient to fund our planned operations for at least the next twelve months.

· Research and Development (R&D) Expenses – Research and development expenses decreased by $0.8 million for the three months ended September 30, 2023, compared to the same period in 2022. The Company’s research and development activities for the quarter ended September 30, 2023 consisted of costs associated with investigator initiated clinical trials. During the same period in 2022 and prior to approval of PEDMARK, manufacturing costs pertaining to PEDMARK were allocated to R&D expense in the period incurred, and following approval are reflected in inventory.

· Selling and Marketing Expenses – Selling and marketing expenses include remuneration of our sales and marketing employees, dollars spent on marketing campaigns (sponsorships, trade shows, presentations, etc.), and any activities to support marketing and sales activities. Selling and marketing expenses for the third quarter of 2023 were $3.4 million compared to $2.3 million in the second quarter of 2023 as the Company increased marketing in the U.S. and pre-commercialization activities in Europe.

· General and Administrative (G&A) Expenses – For the three-month period ended September 30, 2023, G&A expenses decreased by $3.2 million over the same period in 2022. Further, G&A expenses decreased by $1.7 million compared to the second quarter of 2023. The decrease in G&A was primarily because of decreases in non-cash employee remuneration which accounted for $1.0 million of the decrease over same period in 2022. There was a reduction in legal expenses of $0.7 million for the quarter ended September 30, 2023 over the same period in 2022.

· Net Loss – Net loss for the quarter ended September 30, 2023, was $1.9 million ($0.07 per share), compared to $8.1 million ($0.31 per share) for the same period in 2022.

Q3 2023 CONFERENCE CALL INFORMATION

The Company will host a conference call today, November 6, at 8:30 a.m. ET, to discuss the Company’s financial results from the third quarter, ended September 30, 2023, and provide a business outlook for the remainder of 2023.

To access the conference call, please register at: https://register.vevent.com/register/BId73242c7355a46d19e6aa1ff15435b87. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.fennepharma.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. A webcast replay of the conference call will also be archived on www.fennecpharma.com for thirty days.

Financial Update

The selected financial data presented below is derived from our unaudited condensed consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete unaudited condensed consolidated financial statements for the period ended September 30, 2023, and management’s discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

EORTC and Immunocore are collaborating to launch the ATOM clinical trial of tebentafusp in Adjuvant Uveal Melanoma

On November 7, 2023 European Organisation for Research and Treatment of Cancer (EORTC) reported a collaboration with Immunocore, which marks the beginning of the ground-breaking clinical trial ATOM investigating the adjuvant treatment of uveal melanoma with tebentafusp (Press release, EORTC, NOV 7, 2023, View Source [SID1234637133]).

This partnership marks a crucial step forward in our mission to enhance the prognosis and treatment options for individuals facing uveal melanoma, a rare and challenging form of eye cancer. Together with Immunocore, we are committed to pushing the boundaries of scientific research to develop innovative therapeutic interventions that will potentially improve the lives of those affected by this condition.

"Tebentafusp is the first therapy proven to improve survival in HLA-A*02:01 patients with metastatic uveal melanoma1 and as a result has become a new standard of care. The next major challenge is to establish whether tebentafusp can reduce the chance of relapse in HLA-A*02:01 patients following treatment for high-risk primary uveal melanoma. The ATOM trial will test whether 6 months of adjuvant tebentafusp will improve relapse-free survival and has been keenly awaited by our patients and the international uveal melanoma clinical community. I am delighted that the EORTC/Immunocore collaboration facilitates this critical study."

– Professor Paul Nathan PhD FRCP, ATOM study coordinator

About Uveal Melanoma
Uveal melanoma is a rare disease arising from the pigmented uveal tract of the eye with an incidence in Europe of 4.4 cases per million. Metastases usually appear within a median of 3-5 years after treatment of high-risk primary tumours and treatment of metastatic disease is usually with palliative intent. Very few studies have tested the use of adjuvant treatment in uveal melanoma, and none have resulted in any change in the standard of care reflecting a previous lack of active agents for this disease.

About tebentafusp
Tebentafusp is a first-in-class bispecific soluble protein comprising a T-cell receptor (TCR) that binds to a peptide from the gp100 protein presented on tumour cells by human leukocyte antigen (HLA)-A*02:01, and an antibody binding fragment directed against CD3 expressed on T cells. Gp100 is normally expressed in cutaneous and uveal melanocytes and is overexpressed in both skin and uveal melanoma. Tebentafusp recruits T cells to target and kill gp100+ tumour cells.

A recent study2 demonstrated that tebentafusp prolongs overall survival as compared with the investigator’s choice (IC) of pembrolizumab, ipilimumab, or dacarbazine in first-line metastatic uveal melanoma (HR=0.68, 95% CI: 0.54-0.87 with durable benefit seen at the 3 years landmark.

About ATOM
ATOM is an EORTC-led randomized open-label international multicentre phase III superiority clinical trial aiming to prospectively assess whether adjuvant treatment with tebentafusp improves relapse-free survival as compared with observation. A total of 290 patients will be enrolled within a span of three years, beginning in 11 countries, and with the potential for further expansion. The anticipated First Patient, First Visit (FPFV) date is in the second half of 2024.

The goal of the experimental treatment strategy in our trial is to establish whether adjuvant tebentafusp increases the proportion of patients who do not develop metastatic disease and therefore cures a proportion of patients who would have otherwise relapsed.

Patients with high-risk primary ocular melanoma included in the study must have undergone definitive treatment by surgery or radiotherapy, be HLA-A*02:01 positive, have a good performance status (ECOG 0/1), and adequate organ function. Eligible patients will be randomized 1:1 to receive either active treatment with weekly tebentafusp or observation. Patients will receive tebentafusp for 6 months, or until relapse.

The secondary objectives are to compare overall survival and to further document the safety and tolerability of tebentafusp.

The exploratory objectives include the comparison of the health-related quality of life between the treatment arms and the evaluation of the role of circulating tumour DNA (ctDNA) as a biomarker for the presence of residual disease.

Deciphera Pharmaceuticals to Participate in Upcoming Investor Conferences

On November 7, 2023 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that members of the management team will participate in fireside chats at the following investor conferences (Press release, Deciphera Pharmaceuticals, NOV 7, 2023, View Source [SID1234637132]):

Jefferies London Healthcare Conference on Tuesday, November 14, 2023 at 11:00 AM ET / 4:00 PM GMT in London, United Kingdom
Stifel Healthcare Conference on Wednesday, November 15, 2023 at 1:50 PM ET in New York, NY
Piper Sandler 35th Annual Healthcare Conference on Wednesday, November 29, 2023 at 12:00 PM ET in New York, NY
Live webcasts will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source All webcast replays will be archived on the Company’s website for 90 days following the presentation.