On November 10, 2021 "The U.S. FDA approval for TIVDAK represents an important milestone both for the treatment of cervical cancer as well as for Genmab as a company," reported Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab (Press release, Genmab, NOV 10, 2021, View Source [SID1234595080]). "TIVDAK is the first and only approved antibody-drug conjugate (ADC) for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, providing a new treatment option for patients impacted by this devastating disease. The decision by the U.S. FDA also marks the first regulatory approval for an ADC combining Genmab’s antibody with Seagen’s ADC technology and is the first approval for any therapy owned at least 50% by Genmab. This achievement was only possible because of the efforts of our dedicated and talented team, the excellent collaboration with our partner for TIVDAK, Seagen, and the patients, families and caregivers as well as the nurses, physicians and study teams who participated in our clinical trials."

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Financial Performance First Nine Months of 2021

Net sales of DARZALEX by Janssen Biotech Inc. (Janssen) were USD 4,378 million in the first nine months of 2021 compared to USD 2,937 million in the first nine months of 2020, an increase of USD 1,441 million, or 49%.
Royalty revenue was DKK 4,698 million in the first nine months of 2021 compared to DKK 3,090 million in the first nine months of 2020, an increase of DKK 1,608 million, or 52%. The increase was driven by higher net sales of DARZALEX, TEPEZZA and Kesimpta resulting in higher royalties.
Total revenue was DKK 5,863 million in the first nine months of 2021. In addition to the royalty revenue described above, Genmab also recognized DKK 794 million of milestone revenue during the first nine months of 2021. Revenue for the first nine months of 2020 was DKK 8,067 million and included the one-time upfront payment of DKK 4,398 million recognized as license revenue from AbbVie Inc. (AbbVie) pursuant to our collaboration announced in June 2020.
Operating expenses were DKK 3,654 million in the first nine months of 2021 compared to DKK 2,641 million in the first nine months of 2020. The increase of DKK 1,013 million, or 38%, was driven by the continued advancement of multiple pipeline projects, the increase in new employees to support the launch of TIVDAK and expansion of our product pipeline, as well as the continued development of commercialization capabilities and Genmab’s broader organizational infrastructure.
Operating result was DKK 2,209 million in the first nine months of 2021 compared to DKK 5,426 million in the first nine months of 2020. The decrease of DKK 3,217 million, or 59%, was driven by lower revenue as a result of the non-recurring license revenue in 2020 associated with the upfront payment from AbbVie and increased operating expenses.

Outlook
As announced in Company Announcement No. 66, Genmab is improving its 2021 financial guidance published on August 11, 2021, driven primarily by increased royalty revenue related to the net sales of DARZALEX.

Genmab will hold a conference call in English to discuss the results for the first nine months of 2021 today, Wednesday, November 10, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call dial
+1 631 913 1422 (U.S. participants) or +44 3333000804 (international participants) and provide conference code 90392669.

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

On November 10, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, reported that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference on November 16 and 17, 2021 (Press release, Valneva, NOV 10, 2021, View Source [SID1234595079]).

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Valneva’s Chief Executive Officer Thomas Lingelbach and acting Chief Financial Officer David Lawrence will notably discuss the Company’s late stage vaccine candidates against Lyme disease (VLA15), chikungunya (VLA1553) and COVID-19 (VLA2001).

Valneva recently reported positive Phase 3 results for VLA20011, currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. The Company also announced last week the closing of a $102.0 million Global Offering2.

Valneva’s presentation will take place on November 16, 2021 at 4:20pm GMT and can be accessed via the following link: View Source To request a meeting at the event, please contact your representative at Jefferies.

On November 10, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, reported at its virtual Spotlight Event being held today that, following recent discussions with the U.S. Food and Drug Administration ("FDA"), it plans to conduct a new, single-arm Phase 3 pivotal study of UGN-102 for the treatment of low-grade, intermediate-risk, non-muscle invasive bladder cancer ("NMIBC") (Press release, UroGen Pharma, NOV 10, 2021, View Source [SID1234595078]). This new study, which is expected to initiate in early 2022, is expected to enroll approximately 220 patients across 90 sites.

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"We have worked diligently with the FDA over the past several years to define the unmet need in low-grade NMIBC, with a particular focus on the intermediate risk population that typically experiences multiple recurrences," said Liz Barrett, President and Chief Executive Officer of UroGen. "We are preparing to initiate a single-arm pivotal study of UGN-102 to form the basis for a New Drug Application for UGN-102 in the treatment of low-grade, intermediate-risk NMIBC. We believe this new study increases the probability of regulatory success for UGN-102 given its streamlined design in addition to the encouraging results observed from our Phase 2 OPTIMA II study."

UroGen is grateful to the investigators and patients who are participating in the ATLAS study and believes the data generated will represent an important component of the planned UGN-102 NDA submission, which remains on track for 2024. In light of the new planned Phase 3 trial, UroGen will stop enrollment in the ATLAS trial. Patients already enrolled in ATLAS will have the option to remain in the study until completion.

In addition to the updated clinical plan for UGN-102, the Spotlight Event features presentations on UroGen’s earlier-stage, locally administered immunotherapy candidates, UGN-301 and UGN-201, as well as two expert panel discussions on future directions in treating NMIBC, other types of bladder cancer and the potential benefits of UroGen’s immunotherapy pipeline products in non-urologic cancers.

Distinguished panelists discussing the current treatment landscape and potential future innovations in NMIBC include:

Dr. Sandip Prasad, a urologist in community practice with Atlantic Medical Group and the Morristown Medical Center;
Dr. Gary Steinberg, Professor of Urology and Director of the Bladder Cancer Program at NYU Langone Medical Center; and
Dr. William Huang, Professor of Urology and Radiology at NYU and Chief of Urology at Tisch Hospital.
The experts reviewing the unmet needs of patients with high-grade NMIBC and the potential for locally applied combination therapy include:

Dr. Karim Chamie, Associate Professor of Urology at UCLA Medical Center; and
Dr. Joshua Meeks, Associate Professor of Urology, Biochemistry and Molecular Genetics at Northwestern University Feinberg School of Medicine.
"Immunotherapy for the treatment of high-grade bladder cancer, with primary attention toward our TLR-7 agonist, UGN-201 and our anti-CTLA4 antibody, UGN-301, is a key area of focus of our earlier-stage pipeline," said Dr. Mark Schoenberg, Chief Medical Officer of UroGen. "We have pursued a series of pre-clinical studies to determine whether our RTGel platform might provide a method for delivering highly potent immunomodulators directly to the bladder surface, avoiding the toxicity associated with systemic administration. Our studies conducted to-date suggest bladder cancer treated with a combination of a TLR-7 agonist and an anti-CTLA4 antibody using our RTGel technology, produces improved survival relative to treatment with other checkpoint inhibitors in RTGel, either alone or in combination with UGN-201."

UroGen is currently conducting non-human primate toxicity studies to facilitate the initiation of a multi-arm Phase 1 study of UGN-301 in early 2022 to be followed by UGN-301 in combination with other agents. This approach leverages UroGen’s unique platform for drug delivery and provides an opportunity to evaluate intravesical delivery of its anti-CTLA4 monoclonal antibody in combination with other immuno-modulators, chemotherapies, gene therapy and innate immune stimulators, including UGN-201.

On November 10, 2021 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company with proprietary technology platforms to reduce the economic and social burden of prescription drug abuse and overdose, reported that it has completed its previously announced private placement under a securities purchase agreement with institutional investors ("Investors") for senior secured convertible notes (the "Notes") and warrants exercisable for Ensysce common stock (the "Warrants") for an aggregate investment of $15 million (Press release, Leisure Acquisition, NOV 10, 2021, View Source [SID1234595075]). The final funding by the Investors of $10 million, prior to fees and offering expenses, occurred on November 5, 2021.

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The Notes are convertible into shares of Ensysce common stock at a conversion price of $5.87, a 30% premium to the base price set at the time of the initial closing. The Notes have a maturity date of 21 months from the applicable closing date and will bear interest from date of issuance at 5.0% per annum, with monthly principal payments in cash or common stock beginning approximately 90 days after the initial closing. The Notes were issued with an original discount of six percent (6%). The Warrants have the right to purchase shares of common stock at an exercise price of $7.63, a 30% premium to the conversion price. The Warrants are exercisable for five years following the date of issuance.

The total gross proceeds from the issuance of the Notes pursuant to the securities purchase agreement, totaling $15 million before fees and expenses, will be used for general working capital purposes. The first closing on September 24, 2021 provided $5 million of funding and the second closing on November 5, 2021 provided $10 million of funding. At the second closing, the Company issued to the institutional investors referenced above, (i) Notes in the aggregate principal amount of $10.6 million for an aggregate purchase price of $10 million and (ii) Warrants to purchase 722,317 shares of the Company’s common stock at an exercise price of $7.63.

"The completion of our financing provides us with additional and necessary proceeds to continue our advancement of our lead clinical trial programs, including completion of our PF614-102 bioequivalence study and our nasal and oral human abuse liability studies, as a well as to continue the clinical development of our overdose protection platform with our lead product PF614-MPAR," said Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences. "We remain focused on our commitment to stem the prescription drug abuse epidemic by bringing our unique pipeline of products to the industry, which will ultimately provide safer options for both prescribers and patients."

A registered broker-dealer is acting as the sole placement agent in connection with the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful. This news release is being issued pursuant to and in accordance with Rule 135c under the Securities Act of 1933, as amended.

On November 10, 2021 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its unique ability to decode the gut microbiome’s interaction with the immune system, reported that its CEO, Pierre Belichard, will present (in person) and participate at the Jefferies London Healthcare Conference in London, UK, which will take place November 16-19, 2021 (Press release, Enterome, NOV 10, 2021, View Source [SID1234595073]).

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Presentation details

Enterome Presentation (in person) – Wednesday November 17, 2021 at 2:25 pm GMT

Webcast: View Source

The presentation will be webcast live and archived for 30 days thereafter.

Enterome’s CEO, Pierre Belichard, will provide an overview of the Company and the progress it has made with its advanced OncoMimics pipeline of transformational medicines for cancer as well as its other fully owned EndoMimics pipeline for immune diseases.

Enterome’s most advanced OncoMimics drug candidates are:

EO2401, a therapeutic cancer vaccine candidate currently in clinical development for recurrent glioblastoma and adrenal tumors. EO2401 has already shown strong immunogenicity data in brain and adrenal cancer patients with clinical proof of concept data expected in H1 2022, and
EO2463, a second OncoMimic cancer vaccine, in clinical development for the treatment of indolent non-Hodgkin lymphoma with clinical proof of concept data planned for H1 2023
In addition, the Company’s most advanced EndoMimics candidate is:

EB1010, a new orally delivered bioactive and a potent local inducer of IL-10, which has been selected to provide improved therapeutic outcomes for patients with inflammatory bowel disease (IBD). EB1010 is expected to enter clinical trial in 2023