On June 17, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell its ordinary shares and pre-funded warrants (Press release, UroGen Pharma, JUN 17, 2024, View Source [SID1234644396]). In connection with the proposed offering, UroGen also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the total number of ordinary shares (including those underlying pre-funded warrants) offered in the public offering. There can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering. All of the ordinary shares and pre-funded warrants to be sold in the proposed offering will be offered by UroGen.

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TD Cowen and Guggenheim Securities are acting as joint book-running managers for the proposed offering. Oppenheimer & Co. is acting as lead manager for the proposed offering. Ladenburg Thalmann is acting as co-manager for the proposed offering.

The proposed offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, filed with the Securities and Exchange Commission (the "SEC") and declared effective on November 29, 2022. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement (when available) and accompanying prospectus may be obtained by contacting TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, telephone: (212) 518-5548, email: [email protected].

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 prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On June 17, 2024 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP) (Press release, Northwest Biotherapeutics, JUN 17, 2024, View Source [SID1234644399]). The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies. The license is the culmination of more than 2 years of discussions and negotiations.

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The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them. The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.

The DC based therapies include versions with tumor antigens loaded into the DCs and versions for intra-tumoral administration without pre-loading of antigens. Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third Phase 2 trial for a third cancer is pending. The trials are fully funded by grant funding and are being conducted as investigator led trials. The Company does not anticipate having to provide any funding or undertake any operational role for these trials.

As previously reported, over time the Company has been quietly in-licensing various technologies and IP from various institutions and entities which it believes can be valuable in building a leading franchise in dendritic cell therapies.

The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski.

The portfolio in-licensed last year includes the foundational technologies and IP, and positive early-stage clinical trial results, developed by the Kalinski group over 17 years before coming to Roswell. The portfolio in-licensed now includes the further work during the last 7 years at Roswell. Taken together, the Company believes that the two portfolios comprise a whole that is greater than the sum of its parts and offer compelling synergies with the Company’s own portfolio. The Company plans to collaborate with Dr. Kalinski on the further clinical development of the combined technologies.

The Company believes that the infrastructure and systems it has developed, and experience it has gained, in producing and delivering personalized living-cell DC based therapies for large numbers of patients make it uniquely positioned to help accelerate the late-stage development of the licensed DC technologies. The Company’s 331-patient Phase 3 clinical trial remains one of the largest personalized cell therapy trials conducted to date, and the Company’s extensive experience treating compassionate use patients has added valuable ongoing "real world" experience.

"We are excited to join forces with Dr. Kalinski, one of the foremost experts on dendritic cell biology and therapies," commented Linda Powers, the Company’s CEO. "We also greatly appreciate the supportiveness of the institutions throughout the long process of working out the arrangements to keep the Kalinski portfolios intact and to license them to NWBio. In the immediate term, we will continue to focus intensively on pursuing the approval and commercialization of DCVax-L for glioblastoma, but we are excited to begin working on growth opportunities with the licensed technologies as well."

The terms of the Roswell license include standard provisions for an upfront license fee and milestones related to the first Phase 2 trial, first Phase 3 trial, first product approval and first commercial sale. If all of the milestones are met, the payments would be approximately $2.3 million. The license terms also include royalties of 4% on product sales (potentially reduced to 3% in the event of royalty stacking).

On June 17, 2024 iTeos Therapeutics, Inc. (Nasdaq: ITOS) ("iTeos"), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, and its development partner GSK, reported to have initiated the first, global Phase 3 registration study of belrestotug + dostarlimab doublet versus placebo + pembrolizumab in patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected non-small cell lung cancer (NSCLC) (Press release, iTeos Therapeutics, JUN 17, 2024, View Source [SID1234644400]).

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"With the initiation of the first Phase 3 study for belrestotug, we are entering a monumental stage in our journey to develop a world-leading oncology company. Nearly 70% of patients with first-line PD-L1 high non-small cell lung cancer rely upon a chemotherapy-free regimen. We believe belrestotug + dostarlimab are poised to potentially advance the therapeutic regimen in this setting and establish new benchmarks," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "Based on our high-quality doublet exceeding its pre-defined efficacy criteria for clinically relevant activity in an interim assessment from the Phase 2 GALAXIES Lung-201 study, we believe initiating the Phase 3 program with this patient population will serve as the foundation to our broader strategy and marks our first step in building a franchise."

The randomized, double-blind, placebo-controlled, multicenter trial will enroll approximately 1,000 patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected NSCLC in North America, South America, Europe and Asia. The primary endpoints of the trial are progression free survival and overall survival. In the GALAXIES Lung-301 trial, patients will be randomized 1:1 to either an intravenous infusion of the belrestotug + dostarlimab doublet or placebo + pembrolizumab.

In May 2024, iTeos announced an interim assessment of the Phase 2 GALAXIES Lung-201 study of the belrestotug + dostarlimab doublet in previously untreated, locally advanced, or metastatic PD-L1 selected NSCLC exceeded pre-defined efficacy criteria for clinically relevant activity and showed an acceptable safety profile in line with the TIGIT:PD-1 class. Clinically meaningful tumor reduction was observed at every belrestotug + dostarlimab dose vs dostarlimab monotherapy.

On June 17, 2024 Exicure reported its First Quarter 2024 Financial Results (Press release, Exicure, JUN 17, 2024, View Source [SID1234644728]).

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First Quarter 2024 Financial Results

Cash Position: Cash and cash equivalents were $0.4 million as of March 31, 2024, as compared to $0.8 million as of December 31, 2023. Subsequent to March 31, 2024, our cash and cash equivalents have decreased to approximately $0.2 million as of May 31, 2024. Subsequent to May 31, 2024, the Company received a $0.7 million loan from DGP Co., Ltd., a significant stockholder. The loan has a maturity of ten months from issuance and interest at a rate of 6.0% per annum is payable at maturity. The Company believes that its cash and cash equivalents are insufficient to continue to fund operations and additional funding is needed in the very near term.

Revenue: On February 5, 2024, the Company entered into a patent license agreement to develop cavrotolimod for potential treatment for hepatitis with a private clinical stage biopharmaceutical company. Under the terms of the agreement, this biopharmaceutical company will receive an exclusive license in the field of hepatitis to all of the Company’s relevant patents. An initial payment of $0.5 million was paid to the Company after the execution of this agreement. The Company will also be entitled to modest royalties on future net sales of all licensed technology during the term of the licensed patents.

Research and Development (R&D) Expense: Research and development expenses were $0 for the quarter ended March 31, 2024, as compared to $1.4 million for the quarter ended March 31, 2023. The decrease in R&D expense for the three months ended March 31, 2024 of $1.4 million reflects the stoppage of clinical, preclinical, and discovery program activities and a reduction in employee headcount with lower employee-related expenses and fewer discovery, preclinical, and clinical program activities resulting from the restructuring activities that the Company announced in December 2021 and September 2022.

General and Administrative (G&A) Expense: General and administrative expenses were $1.3 million for the quarter ended March 31, 2024, as compared to $3.1 million for the quarter ended March 31, 2023. The decrease in G&A expense of $1.8 million for the three months ended March 31, 2024 was mostly due to lower compensation and related payroll costs, professional fees, and operating costs as a result of reduced operations.

Net Loss: The Company had a net loss of $0.8 million for the quarter ended March 31, 2024, as compared to a net loss of $4.4 million for the quarter ended March 31, 2023. The decrease in net loss of $3.6 million was primarily driven by the reduction of payroll and operating costs due to reduced operations, as well as $0.5 million of revenue as a result of a license agreement payment received during the quarter.

Going Concern: Management believes that the Company’s existing cash and cash equivalents is not sufficient to continue to fund operations. The Company has already engaged in significant cost reductions, so our ability to further cut costs and extend the Company’s operating runway is limited. As a result, substantial additional financing is needed in very near term to pay expenses, fund the ongoing exploration of strategic alternatives and pursue any alternatives that may be identified. The Company needs to raise capital to fund its operations. There can be no assurance that such additional financing will be available and, if available, can be obtained on acceptable terms.

On June 17, 2024 Alivexis, Inc. (Headquartered in Minato-ku, Tokyo; CEO S. Roy Kimura) reported that the Company has entered into a Research Collaboration Agreement with Astellas Pharma Inc. ("Astellas") to identify small molecule compounds for a new drug target selected by Astellas, utilizing Alivexis’ drug discovery platform ModBind and other technologies (Press release, Alivexis, JUN 17, 2024, View Source [SID1234644376]).

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The collaboration aims to utilize Alivexis’ computational drug discovery platform, including ModBind, to discover new small molecule compounds which will regulate the function of a novel drug target molecule selected by Astellas. As this target has no reported functional modulators to-date, the collaboration will accelerate the drug discovery of novel therapeutics against the target. In addition to in silico evaluation using the computational drug discovery platform, Alivexis will be responsible for integrated drug discovery research, including the development of experimental assays and compound evaluation using those assays. Under the terms of the collaboration, Astellas will have the option to acquire rights to the research deliverables.

About ModBind.
Alivexis has established a computational drug discovery platform that greatly accelerates small molecule drug discovery, which includes physics-based molecular dynamics simulations using GPUs (Graphics Processing Units), large-scale virtual screening algorithms, and deep learning models. With the help of their computational drug discovery platform, Alivexis has already delivered several clinical candidate molecules for both in-house drug discovery projects and external collaborations. Among Alivexis’ various computational drug discovery tools, the newly developed ModBind is a molecular simulations-based algorithm that can predict the efficacy of drug candidate compounds with high accuracy, yet performs more than 100 times faster than the other state-of-the-art technologies in the field. ModBind is based on a theoretical approach that is fundamentally different from industry standard simulations-based prediction technologies. One significant advantage of ModBind is that it is an absolute predictor of ligand efficacy and does not require known reference compounds, which are usually necessary for other methodologies. Therefore, ModBind is useful in all stages of preclinical drug discovery – from screening large random chemical libraries for initial hit finding to delivering clinical candidates in the lead-optimization stage. This capability has already been proven by Alivexis’ in-house research and external collaborations and is contributing to the progression of many drug discovery projects.

【CEO S. Roy Kimura’s Comments】
"I am excited to announce the signing of our drug discovery collaboration with Astellas focused on the use of our proprietary and ground-breaking ModBind simulation technology to accelerate early drug discovery for a particular disease target. Through our collaboration, we look forward to gaining further validation of our technology while contributing to the discovery of novel clinical candidate compounds for diseases with high patient need."