On August 8, 2022 Genmab A/S (Nasdaq: GMAB) reported that it is improving its 2022 financial guidance published on May 11, 2022 (Press release, Genmab, AUG 8, 2022, View Source,by%20the%20items%20described%20above.&text=Genmab’s%20financial%20results%20for%20the,published%20on%20August%2010%2C%202022. [SID1234617766]). The improved guidance is driven primarily by increased royalty revenue due to higher net sales of DARZALEX and the positive net foreign exchange impact of the strong U.S. Dollar.

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Genmab expects its 2022 revenue to be in the range of DKK 12,000 – 13,000 million, an increase to the previous guidance of DKK 11,000 – 12,000 million, driven primarily by the continued strong growth of DARZALEX net sales as well as the positive impact of the strong U.S. Dollar. Genmab’s projected revenue for 2022 primarily consists of DARZALEX royalties. Such royalties are based on Genmab’s revised estimate of DARZALEX 2022 net sales of USD 7.8 – 8.2 billion compared to Genmab’s previous estimate of USD 7.5 – 8.0 billion.

Genmab anticipates its 2022 operating expenses to be in the range of DKK 7,600 – 8,200 million, an increase to the previous guidance of DKK 7,200 – 7,800 million, driven by increased investment related to pipeline progression and epcoritamab launch readiness activities as well as the negative impact of the strong U.S. Dollar.

Genmab now expects its 2022 operating profit to be in the range of DKK 3,800 – 5,400 million, an increase to the previous guidance of DKK 3,200 – 4,800 million, driven primarily by the items described above.

Genmab’s financial results for the first half of 2022 will be published on August 10, 2022.

The above expectations are based on assumptions including those described on pages 5 and 6 of the Interim Report for the First Quarter of 2022 (Company Announcement No. 17/2022) as well as an updated USD/DKK exchange rate of 6.8, compared to the previous exchange rate of 6.4.

On August 8, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported financial results for the second quarter ended June 30, 2022 and provided an update on recent operational highlights (Press release, Cyteir Therapeutics, AUG 8, 2022, View Source [SID1234617782]).

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"We are encouraged by the enrollment of patients in the CYT-0851 Phase 2 monotherapy cohorts and Phase 1 combination therapy cohorts, with initial data expected on the solid tumor cohorts in the fourth quarter this year, and on the lymphoma cohorts in the first half of 2023," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "We have made the strategic decision to postpone the CYT-1853 IND, thereby extending our cash runway to focus on CYT-0851 clinical development and our synthetic lethality discovery research."

Second Quarter 2022 Business Update

Updates to the CYT-0851 Clinical Program

Progress continues with enrollment of both the monotherapy and combination cohorts. Initial data from the monotherapy solid tumor cohorts are expected beginning in the fourth quarter of 2022, with initial data from the hematologic malignancy cohorts expected in the first half of 2023. Dose-escalation in combination cohorts with capecitabine and gemcitabine in solid tumors is progressing and expected to be completed in the first half of 2023.
A Phase 2 cohort with CYT-0851 monotherapy in triple negative breast cancer has been opened. Data from this cohort are expected in the first half of 2023. Cyteir has made a strategic decision to halt further enrollment in the Phase 2 multiple myeloma monotherapy cohort and the dose-escalation combination cohort with rituximab plus bendamustine. This decision was based on the evolving treatment landscapes in multiple myeloma and diffuse large B-cell lymphoma, and the feasibility of development given the emerging competition.
We continue to perform metabolomic, genomic, and transcriptomic analyses on patient samples to identify potential patient selection biomarkers. Our understanding of the mechanism of action of CYT-0851 could potentially accelerate development of a biomarker and allow for expansion into additional opportunities in other tumor types. Progress on this work is expected to be updated by year-end 2022.
Update on Progress with CYT-1853

The development of CYT-1853 is paused and the filing of an Investigational New Drug (IND) application is postponed while Cyteir continues to evaluate the clinical results of the ongoing studies with CYT-0851. Accordingly, Cyteir will prioritize its resources on advancing CYT-0851 in the clinic and on its discovery research efforts to expand the company’s synthetically lethal preclinical pipeline.
Second Quarter 2022 Financial Results

Cash and cash equivalents: Cash and cash equivalents as of June 30, 2022 were $166.4 million. As a result of updates from the CYT-0851 program review and postponing CYT-1853 development, cash and cash equivalents are now expected to fund planned operations into the second half of 2024, which is longer than we previously forecasted.

Research and development (R&D) expenses: R&D expenses were $8.8 million for the second quarter of 2022 versus $8.9 million for the same period in 2021. The year-over-year decrease in R&D spending in the comparative periods was due primarily to decreased costs in external research activity offset by increased clinical trial expenses for the ongoing Phase 1/2 study of CYT-0851 and headcount.

General and administrative (G&A) expenses: G&A expenses were $3.4 million for the second quarter of 2022 compared to $2.4 million for the same period in 2021. The year-over-year increase in G&A expenses in the comparative periods was primarily due to employee-related costs, as well as other administrative expenses associated with company growth and operating as a public company.

Net loss: Net loss was $12.1 million, or $0.34 per share, in the second quarter of 2022 compared to $11.3 million, or $4.83 per share, for the same period in 2021.

On August 8, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the second quarter ended June 30, 2022 (Press release, Delcath Systems, AUG 8, 2022, View Source [SID1234617798]).

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Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. (PRNewsfoto/Delcath Systems, Inc.)

Recent Business Highlights

During and since the second quarter, Delcath:

Held a pre-NDA meeting with FDA and locked the phase 3 FOCUS Trial database for the purpose of resubmitting the NDA for the Hepzato Kit (melphalan hydrochloride for injection/hepatic delivery system) in the third quarter of 2022,
Presented a poster updating the results from the FOCUS Trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting,
Opened two Expanded Access Program (NCT05022901) sites, and
Raised $5 million in a private placement priced at market.
In addition, during and since the fourth quarter, independent investigators:

Published Predictive Parameters in Patients Undergoing Percutaneous Hepatic Perfusion with Melphalan for Unresectable Liver Metastases from Uveal Melanoma: A Retrospective Pooled Analysis in the journal Cardiovascular and Interventional Radiology,
Presented two abstracts on the use of Chemosat Hepatic Delivery System with Melphalan in the treatment of metastatic uveal melanoma at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, including:
Safety and efficacy of combined melphalan percutaneous hepatic perfusion (M-PHP) and ipilimumab plus nivolumab (IPI+NIVO) in metastasized uveal melanoma: First results of the phase Ib part of the CHOPIN trial, and
Temporal evolution in quality-of-life following melphalan percutaneous hepatic perfusion for patients with metastatic uveal melanoma.
"As we prepare to resubmit the Hepzato Kit NDA by the end of the third quarter, Chemosat usage in Europe continues to result in publications supportive of both Chemosat and by extension the Hepzato Kit," said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel continued, "We would expect that within 30 days of the resubmission, the FDA will confirm receipt of the submission and, if they agree the resubmission is sufficiently complete to warrant review, establish a PDUFA date sometime late in the first quarter of 2023."

First Quarter 2022 Results

Income Statement Highlights.

Total revenue for the three months ended June 30, 2022, was approximately $0.8 million, compared to $0.5 million for the prior year period, from our sales of CHEMOSAT in Europe. This increase in product revenue is primarily due to a full quarter of direct product sales by Delcath compared to the revenue share arrangement with our distribution partner in Europe in 2021.

Research and development expenses for the quarter were $5.5 million, compared to $3.5 million in the prior year quarter. The growth in R&D expense is primarily due to increased activity related to the NDA preparation. Selling, general and administrative expenses for the quarter were approximately $4.1 million, compared to $3.3 million in the prior year quarter. Total operating expenses for the quarter were $9.6 million, compared with $6.8 million in the prior year quarter.

The Company recorded a net loss for the three months ended June 30, 2022, of $9.7 million, compared to a net loss of $6.4 million for the same period in 2021.

Balance Sheet Highlights

On June 30, 2022, the Company had cash, cash equivalents and restricted cash totaling $14.4 million, as compared to cash, cash equivalents and restricted cash totaling $27.0 million on December 31, 2021. During the three months ended June 30, 2022, and June 30, 2021, we used $6.1 million and $7.1 million, respectively, of cash in our operating activities.

On July 20, 2022, Delcath closed a private placement for the issuance and sale of 690,954 shares of common stock (the "Common Stock") and 566,751 pre-funded warrants to purchase Common Stock (the "Pre-Funded Warrants") to certain investors. Each share of Common Stock was sold at a price per share of $3.98 and the Pre-Funded Warrants were sold at a price of $3.97 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.01 per share of Common Stock and are immediately exercisable. Delcath received gross proceeds from the Private Placement of approximately $5.0 million before deducting offering expenses payable by Delcath. Delcath intends to use the net proceeds from the Private Placement for working capital purposes and other general corporate purposes.

On August 8, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, reported that the company will host a conference call and live audio webcast on Monday, August 15, 2022, at 8:00 a.m. ET to review its second quarter 2022 financial results and provide an update on the company (Press release, Gamida Cell, AUG 8, 2022, View Source [SID1234617813]).

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To access the conference call, please register here and be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

On August 8, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported a global collaboration that provides GSK plc (LSE/NYSE: GSK) an exclusive option to co-develop and commercialize XMT-2056, an Immunosynthen ADC that targets a novel epitope of HER2 (Press release, Mersana Therapeutics, AUG 8, 2022, View Source [SID1234617842]). XMT-2056 is designed to activate the innate immune system through STING signaling in both tumor-resident immune cells and in tumor cells.

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"GSK brings highly complementary development and commercial capabilities, a wealth of immuno-oncology experience, a deep knowledge of the STING pathway and a shared vision for XMT-2056’s broad potential," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "We believe this agreement solidifies Mersana’s position as a partner of choice during this momentous period in the ADC space and serves as validation for our Immunosynthen platform, which takes ADCs beyond the cytotoxic realm by enabling a targeted stimulation of the innate immune system. Additionally, the agreement structure demonstrates our ability to generate meaningful non-dilutive capital upfront to support the development of our innovative candidates while also providing the potential for meaningful downstream economics."

In preclinical models, XMT-2056 demonstrated robust anti-tumor activity as a monotherapy in both HER2-high and HER2-low expressing models, and enhanced efficacy has been shown when used in combination with multiple approved agents, including trastuzumab, pertuzumab, anti-PD-1, or trastuzumab deruxtecan. Preclinical data also suggest that XMT-2056 has the potential to enable immunological memory for prolonged anti-tumor activity.

Mersana expects to initiate a Phase 1 clinical trial of XMT-2056 to investigate its potential in a range of HER2-expressing tumors such as breast, gastric and non-small-cell lung cancers. The U.S. Food and Drug Administration recently granted an orphan drug designation to XMT-2056 for the treatment of gastric cancer.

John Lepore, Senior Vice President of Research, GSK, said, "At GSK, our goal is to bring transformational treatment options to patients with cancer, so we are pleased to be able to enter into this agreement for XMT-2056. Its preclinical data demonstrate how it might work to harness the immune system by activating the STING pathway, and its differentiated mechanism of action offers the potential for additional clinical benefit in patients with HER2-expressing tumors."

Under the terms of the agreement, Mersana will receive an upfront option purchase fee of $100 million. Mersana also is eligible to receive up to $1.36 billion in the form of an option exercise payment and development, regulatory and commercial milestone payments if GSK exercises its option.

Mersana has retained options to profit-share and to co-promote in the United States. If it exercises its profit-share option, Mersana will be eligible to receive tiered royalties on net sales outside of the United States. If Mersana does not elect to profit-share, it is eligible to receive double-digit tiered royalties on global net sales.

If GSK opts into the license, the effectiveness of the license grant may be subject to customary closing conditions, including review under the Hart-Scott-Rodino Act.

Conference Call Reminder
Mersana will host a conference call today at 4:30 p.m. ET to discuss this collaboration, other business updates and its financial results for the second quarter of 2022. To access the call, please dial 646-307-1963 (domestic) or 800-715-9871 (international) and provide the Conference ID 4656534. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for at least 90 days.