On October 19, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, reported the closing of its merger with Biosight, Ltd. ("Biosight"), pursuant to which Ayala acquired Biosight (Press release, Ayala Pharmaceuticals, OCT 19, 2023, View Source [SID1234636135]). The combined company will operate under the name Ayala Pharmaceuticals, Inc., and its shares will continue to trade on the OTCQX under Ayala’s current ticker symbol ("ADXS").

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"We are pleased to close the merger with Biosight which expands our product pipeline," said Ken Berlin, President & CEO. "We have added aspacytarabine (BST-236), a novel antimetabolite, which is in clinical development for AML and could potentially serve as a superior backbone therapy for unfit AML as part of combination treatment regimens. Our primary focus continues to be completing the ongoing Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors and we look forward to continuing our mission of bringing innovative therapies to people with rare tumors and aggressive cancers."

Management and Organization

As previously announced, the combined company will be led by Ayala’s existing senior management team, with Ken Berlin serving as President and CEO; Andres Gutierrez, MD, PhD, Executive VP and Chief Medical Officer; and Dana Gelbaum, MSc, MBA, General Manager and Chief Business Officer. Roy Golan, CPA, LLM, previously Executive VP & CFO of Biosight, has been appointed Chief Financial Officer of the combined company. The board of directors of the combined company is comprised of David Sidransky, MD (Chairman); Robert Spiegel, MD, FACP; Murray Goldberg; Vered Bisker-Leib, PhD, MBA; Roni Appel, MBA; Pini Orbach, PhD; Yuval Cabilly, PhD; and Ken Berlin, with an additional board member expected to be added at a later date.

On October 19, 2023 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) reported that it will release financial and operational results for the third quarter of 2023, on Thursday, November 2, 2023, before markets open (Press release, Aurinia Pharmaceuticals, OCT 19, 2023, View Source [SID1234636134]). Aurinia’s management team will host a conference call/webcast at 8:30 am ET that day to review these results and provide a general business update. Interested participants can dial 877-407-9170 / +1 201-493-6756 (Toll-free U.S. & Canada). The audio webcast can also be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

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On October 19, 2023 Amgen (NASDAQ:AMGN) reported that it will host a webcasted call for the investment community at 8:00 a.m. ET on Tuesday, Oct. 24, 2023 following the presentation of new data from Amgen’s innovative oncology portfolio including AMG 193 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) 2023 and data from tarlatamab, xaluritamig, and LUMAKRAS (sotorasib) that will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 (Press release, Amgen, OCT 19, 2023, View Source [SID1234636133]). David M. Reese, M.D., executive vice president of Research and Development at Amgen, members of Amgen’s development team as well as clinical investigators will participate. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On October 19, 2023 4SC AG (4SC or "the Company") (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), reported a business update for the three months ended 30 September 2023, as well as its current outlook (Press release, 4SC, OCT 19, 2023, View Source [SID1234636118]). The full report is available for download on 4SC’s website.

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4SC is focused primarily on the development of resminostat (Kinselby), and, in particular, preparation of the marketing authorisation for the commercialization of resminostat (Kinselby), a unique maintenance treatment for CTCL.

Key highlights of Q3 2023
Data from the Company’s RESMAIN study was published in September 2023 at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting. In this study, resminostat (Kinselby) showed*:
A statistically significant improvement in progression free survival (median PFS: 8.3 vs. 4.2 months; p=0.015; HR: 0.623)
A median time to next treatment versus placebo showed a significant improvement of 8.8 months compared to 4.2 months
A clinically meaningful improvement in median "total" PFS of 24.3 months, compared to 14.9 months for those in the placebo group
Side effects of resminostat were mainly mild to moderate, manageable and reversible
In Q3, 4SC has been actively progressing the preparation of its Marketing Authorization Application in the European Union, Switzerland and the United Kingdom
In addition, a significant effort has been made in preparing for discussions with the United States (US) Food and Drug Administration regarding requirements for marketing resminostat (Kinselby) for CTCL in the US
On 27 September 2023, the Company announced that the US FDA had granted resminostat (Kinselby) orphan drug designation, which gives a number of benefits, most importantly seven years’ market exclusivity in the US
4SC’s partner for Japan, Yakult Honsha Co. Ltd (Yakult Honsha) is continuing with its preparation and filing of a marketing application for resminostat (Kinselby) in Japan.
Cash balance development in Q3 2023 and financial forecast
As at 30 September 2023, 4SC held cash balance/funds of €10.44 million compared to €12.16 million as of 30 June 2023. The decrease of cash funds in the first nine months of 2023 is mainly a result of the expenditure on the ongoing RESMAIN clinical study.

The monthly use of cash from operations amounted to €487 thousand in Q3 2023. The average monthly use of cash for 2023 is now expected to be between €500 – €700 thousand, a significant reduction from the previous forecast of between €800 thousand – €1.1 million.

Based on current financial and operating activities, the Manage­ment Board estimates that current funds should now be sufficient to finance 4SC into the third quarter of 2024, longer than previously expected.

Post Period Event
In October 2023, the European Commission adopted the European Medicines Agency’s decision to grant orphan drug designation to resminostat (Kinselby) in cutaneous T-cell lymphoma (CTCL). Orphan drug designation (ODD) provides privileged status to drugs that show promise for the treatment of rare diseases in the European Union. ODD qualifies 4SC for benefits including protocol assistance, market exclusivity and fee reductions.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "The last quarter has been a very busy and productive period for 4SC. Not only has the RESMAIN study demonstrated the significant benefit of resminostat (Kinselby) as a maintenance treatment for patients suffering from CTCL, a debilitating and incurable condition, but we have also secured orphan drug designation in both the US and, post period, in Europe. This designation comes with meaningful benefits, including market exclusivity for seven and ten years respectively. We remain focused on securing marketing authorization for resminostat (Kinselby) and are actively engaged in finding the right partner to take Kinselby forward to patients."

On October 23, 2023 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, announced today that it has entered into a securities purchase agreement to sell securities in a private placement that is expected to result in gross proceeds of approximately $50 million (Press release, Celcuity, OCT 18, 2023, View Source [SID1234636240]). In the private placement, an institutional investor has agreed to purchase pre-funded warrants to purchase shares of Celcuity’s common stock at a price of $8.699 per warrant, each with an exercise price of $0.001 per share (for aggregate consideration equating to $8.70 per share). Subject to certain limitations, each pre-funded warrant will be exercisable immediately. The closing of the private placement is subject to customary closing conditions and is expected to occur on October 20, 2023. The Company expects to use the net proceeds to advance clinical development of gedatolisib and for general corporate purposes.

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The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other jurisdiction’s securities laws, and accordingly may not be offered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the SEC registering the resale of the shares of common stock issuable upon the exercise of the pre-funded warrants purchased in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.