The RT2831 project of Regenecore officially obtained IND approval by FDA

On July 25, 2024 Nanjing RegeneCore Biotech reported the RT2831 project has officially obtained Investigational New Drug Application (IND) approval by FDA, USA (Press release, Nanjing RegeneCore Biotech, JUL 25, 2024, View Source [SID1234649773]). This is another major breakthrough for the Regenecore team in the field of tumor treatment after autoimmune diseases, and also the second IND approval for nanobody drugs obtained by the Regenecore team.

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Regenecore will continue to increase research and development investment, promote the RT2831 project to achieve more positive results in clinical research, and bring more blessings to cancer patients. At the same time, We will actively explore more innovative drugs and continue to move forward firmly on the path of "maintaining human health with excellent drugs".

H1 and Q2 2024 Results

On July 25, 2024 AstraZeneca the company reported its first half 2024 results (Presentation, AstraZeneca, JUL 25, 2024, View Source [SID1234647221]).

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Roche sales increase by 5% (CER) in first half of 2024; strong growth in second quarter – full-year earnings outlook raised

On July 25, 2024 Hoffmann-La Roche reported its sales increase by 5% (CER) in first half of 2024; strong growth in second quarter – full-year earnings outlook raised (Presentation, Hoffmann-La Roche, JUL 25, 2024, View Source [SID1234646007]).

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Ipsen delivers strong results in the first half of 2024, progresses on launches and upgrades its full-year guidance

On July 25, 2024 Ipsen, a global specialty-care biopharmaceutical company, reported its financial results for the first half of 2024 (Press release, Ipsen, JUL 25, 2024, View Source [SID1234645314]).

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Business highlights
» U.S. regulatory approvals and launches of Onivyde (irinotecan) in first-line pancreatic cancer and Iqirvo (elafibranor) in second-line primary biliary cholangitis, respectively
» In-licensing of tovorafenib outside the U.S.: an attractive addition to our Oncology pipeline
» Multiple early-stage external-innovation transactions across Oncology and Neuroscience

Financial highlights
» Total-sales growth of 9.5% at CER1 , or 8.0% as reported, driven by the performances of Cabometyx (cabozantinib) and Dysport (abobotulinumtoxinA), as well as contributions from Bylvay (odevixibat) and Onivyde
» Core operating margin of 32.4%, a decline of 1.6% points, driven mainly by enhanced R&D investment. An unchanged IFRS operating margin of 19.2%
» Upgraded 2024 financial guidance: total-sales growth greater than 7.0% at CER1 (prior guidance: greater than 6.0% at CER1 ); core operating margin greater than 30.0% of total sales (prior guidance: around 30%)

Novocure Reports Second Quarter 2024 Financial Results

On July 25, 2024 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended June 30, 2024 (Press release, NovoCure, JUL 25, 2024, View Source [SID1234645100]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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"The second quarter was a period of consistent execution at Novocure," said Asaf Danziger, Novocure’s Chief Executive Officer. "We began the year with three key objectives – grow our commercial business in glioblastoma, launch our next indication in non-small cell lung cancer, and deliver on the promise of our clinical and product development pipelines. I am pleased to share we have made significant progress on all fronts this quarter."

Financial updates for the second quarter ended June 30, 2024:

Total net revenues for the quarter were $150.4 million, an increase of 19% compared to the same period in 2023. This increase is primarily driven by our successful launch in France and improved U.S. approval rates.
The United States, Germany, France and Japan contributed $95.7 million, $15.1 million, $14.3 million and $7.7 million, respectively, with other active markets contributing $11.8 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.8 million.
Improved approval rates in the U.S. resulted in $5.0 million of increased net revenue from prior period claims during the quarter. In addition, we received $2.6 million in net revenues from a private payer in the United Kingdom where payments are not routine. We do not expect these two benefits, totaling $7.6 million, to recur.
Gross margin for the quarter was 77%.
Research, development and clinical studies expenses for the quarter were $55.0 million, a decrease of 1% from the same period in 2023.
Sales and marketing expenses for the quarter were $56.6 million, a decrease of 3% compared to the same period in 2023. This primarily reflects lower personnel expenses associated with support functions.
General and administrative expenses for the quarter were $37.7 million, a decrease of 8% compared to the same period in 2023. This primarily reflects lower personnel expenses.
Net loss for the quarter was $33.4 million with loss per share of $0.31.
Adjusted EBITDA* for the quarter was $1.1 million.
Cash, cash equivalents and short-term investments were $951.2 million as of June 30, 2024.
Operational updates for the second quarter ended June 30, 2024:

1,634 prescriptions were received in the quarter, an increase of 5% compared to the same period in 2023. Prescriptions from the United States, Germany, France and Japan contributed 957, 206, 176 and 108 prescriptions, respectively, with the remaining 187 prescriptions received in other active markets.
As of June 30, 2024, there were 3,963 active patients on therapy, an increase of 11% compared to the same period in 2023. Active patients from the United States, Germany, France and Japan contributed 2,175, 538, 369 and 403 active patients, respectively, with the remaining 478 active patients contributed by other active markets.
Quarterly updates and achievements:

In June, we presented positive results from the phase 3 METIS trial, evaluating the use of TTFields therapy and supportive care for the treatment of patients with brain metastases from non-small cell lung cancer (NSCLC) following stereotactic radiosurgery at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The METIS trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with TTFields therapy and supportive care compared to patients treated with supportive care alone.
In June, we presented top-line results from the prospective, non-interventional TIGER study at the 2024 ASCO (Free ASCO Whitepaper) annual meeting. TIGER investigated the use of TTFields therapy in routine clinical use in the treatment of newly diagnosed GBM in Germany. The outcomes observed in the TIGER study are consistent with the survival and safety results from our phase 3 EF-14 clinical trial. TTFields therapy use was not associated with an increase in systemic toxicity and was well tolerated.
Anticipated clinical milestones:

Top-line data from phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer (Q4 2024)
Conference call details

Novocure will host a conference call and webcast to discuss second quarter 2024 financial results at 8:00 a.m. EDT today, Thursday, July 25, 2024. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.