On May 5, 2021 Genmab reported that Interim Report for the First Quarter Ended March 31, 2021 (Press release, Genmab, MAY 5, 2021, View Source [SID1234579177])

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Highlights

Genmab and Seagen Inc. submitted tisotumab vedotin Biologics License Application (BLA) to the U.S. FDA for patients with recurrent or metastatic cervical cancer
First patient dosed in Phase 3 epcoritamab study triggers USD 40 million milestone in collaboration with AbbVie Inc.
DARZALEX net sales increased 46% compared to the first quarter of 2020 to USD 1,365 million, resulting in royalty income of DKK 984 million
Janssen Biotech, Inc. granted U.S. FDA approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for patients with newly diagnosed light-chain (AL) amyloidosis
Novartis received a positive CHMP opinion, followed by approval in Europe, for Kesimpta (ofatumumab) in the treatment of relapsing forms of multiple sclerosis in adults with active disease defined by clinical or imaging features
Tahamtan Ahmadi appointed Executive Vice President and Chief Medical Officer, Head of Experimental Medicines
"In 2020, Genmab reached an inflection point in our evolution into a fully integrated biotech innovation powerhouse. This momentum has continued into the first quarter of 2021, with the BLA submission for tisotumab vedotin, our product in development with Seagen. If approved by the U.S. FDA, we believe that tisotumab vedotin as monotherapy has the potential to become an important treatment option for women with recurrent or metastatic cervical cancer, who have disease progression on or after chemotherapy," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2021

Revenue was DKK 1,581 million in the first quarter of 2021 compared to DKK 892 million in the first quarter of 2020. The increase of DKK 689 million, or 77%, was primarily driven by higher DARZALEX royalties and milestones related to epcoritamab and DARZALEX FASPRO.
Net sales of DARZALEX by Janssen Biotech Inc. (Janssen) were USD 1,365 million in the first quarter of 2021 compared to USD 937 million in the first quarter of 2020, an increase of USD 428 million, or 46%.
Operating expenses were DKK 1,049 million in the first quarter of 2021 compared to DKK 821 million in the first quarter of 2020. The increase of DKK 228 million, or 28%, was driven by the continued advancement of multiple pipeline projects, and the increase in new employees to support the expansion of our product pipeline and building our commercialization capabilities and infrastructure.
Operating result was DKK 532 million in the first quarter of 2021 compared to DKK 71 million in the first quarter of 2020. The increase of DKK 461 million was driven by higher revenue, which was partly offset by increased operating expenses.
Outlook
Genmab is maintaining its 2021 financial guidance published on February 23, 2021.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2021 today, Wednesday, May 5, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
+1 631 913 1422 (U.S. participants) or +44 3333 000804 (international participants) and provide conference code 29164332.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

On May 5, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Bank of America Securities 2021 Health Care Conference on Tuesday, May 11, 2021 (Press release, Eli Lilly, MAY 5, 2021, View Source [SID1234579176]). Michael Mason, senior vice president, president of Lilly Diabetes, will participate in a virtual fireside chat at 9:30 a.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On May 5, 2021 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, reported that it has completed the sale of approximately $10 million of its common shares pursuant to the Company’s ATM program established on March 9, 2020 through Jefferies LLC ("Jefferies"), acting as sales agent (Press release, Corvus Pharmaceuticals, MAY 5, 2021, View Source [SID1234579175]).

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An aggregate of 3,564,228 new shares were sold to EcoR1 Capital, a fundamental biotechnology-focused investment advisory firm, and 35,714 new shares were sold to Richard A. Miller, the Company’s co-founder, president and chief executive officer, at an at-the-market price of $2.80 per share. It is anticipated that the settlement and delivery of the new shares will take place on May 6, 2021.

A shelf registration statement on Form S-3 relating to Corvus’ securities being sold was declared effective by the Securities and Exchange Commission on March 19, 2020. Before purchasing shares, prospective investors should read the prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at (877) 821-7388 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

On May 5, 2021 MannKind Corporation (Nasdaq:MNKD) reported that it will release its 2021 first quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, May 12, 2021 (Press release, Mannkind, MAY 5, 2021, View Source [SID1234579152]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven B. Binder.

Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under Events & Presentations. A replay will also be available on MannKind’s website for 14 days.

On May 5, 2021 InDex Pharmaceuticals reported that interim report January – March 2021 (Press release, InDex Pharmaceuticals, MAY 5, 2021, View Source [SID1234579151])

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Period January – March 2021
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –9.3 (–24.0) million
Result after tax amounted to SEK –9.3 (–24.0) million, corresponding to SEK –0.02 per share (–0.10) before and after dilution
Cash flow from operating activities amounted to SEK –8.5 (–21.9) million
Cash and cash equivalents at the end of the period amounted to SEK 532.5 (104.6) million
Number of employees at the end of the period was 7 (7)
Number of shares at the end of the period was 532,687,650
All comparative amounts in brackets refer to the outcome during the corresponding period 2020.

Significant events during January – March 2021
The Board resolved on a fully guaranteed rights issue of approximately SEK 533 million
InDex’s rights issue was oversubscribed and the company received approximately SEK 488 million net
Significant events after the reporting period
No significant events have occurred after the reporting period
Other events during the reporting period
InDex entered an agreement for services with global clinical research organization (CRO) Parexel Biotech for the phase III study CONCLUDE
CEO statement
It has been an intensive beginning of 2021 for InDex, where the crucial pieces of the puzzle for the start of phase III now have fallen into place. In February, we completed a successful rights issue of approximately SEK 533 million. The subscription ratio amounted to as much as 153 percent and more than 99 percent was subscribed for by exercise of subscription rights. HBM Healthcare Investments and Handelsbanken Funds came in as new large owners in the rights issue. These are two internationally recognized and successful life sciences specialists that chose to invest significant amounts, which not only strengthens the ownership base, but also constitutes a strong validation of the potential of InDex.

The rights issue will primarily fund the important initial induction study in a sequential phase III program with cobitolimod for left-sided moderate to severe ulcerative colitis. The results of this induction study will constitute a significant value inflection point and the remaining program can be optimised according to the outcome of the study. We estimate that the study will take 18 to 24 months to complete from initiation.

The study, which has been named CONCLUDE, will be a global study with approximately 400 patients at a few hundred clinics. The primary endpoint, clinical remission, will be measured at week 6. Apart from the dosing 250 mg x 2, which was the highest dose and the one that showed the best efficacy in the phase IIb study CONDUCT, cobitolimod’s excellent safety profile allows to also evaluate a higher dose, 500 mg x 2, in an adaptive study design. This higher dose has the potential to provide an even better efficacy than what was observed in the CONDUCT study.

With the financing in place, we entered into an agreement for services at the end of March with Parexel Biotech for the phase III study. After the successful collaboration in CONDUCT, we are very pleased to collaborate once again with them as our clinical development partner. They are a leading global CRO with considerable experience managing phase III studies in inflammatory bowel disease, which will ensure an efficient execution of CONCLUDE. The clinical study must now be approved by the authorities of each participating country. The goal is to start the study in the second quarter of 2021, but it is subject to the development of the Covid-19 pandemic if authorities and healthcare providers will be able to prioritize the start of new clinical studies in the near future.

On June 3 we have the annual general meeting in InDex, but unfortunately there will not be a physical meeting this year either due to the pandemic. I will present the company at Redeye Growth Day the day before the annual general meeting, on June 2, for those who want an update. I will also present the company at Erik Penser Bank tomorrow, on May 6. You can follow the presentations live or watch them afterwards on our updated website.

I would also like to highlight the recent annual report for 2020. It provides a good overview of ulcerative colitis, cobitolimod, the phase III design and the company in general. Strong stories like our patient interview with 23-year-old Felicia confirm the need for new effective and safe treatment options for ulcerative colitis.

I look forward to a continued eventful year with the start of the phase III study CONCLUDE as the next important milestone.