On May 16, 2024 NuCana plc (NASDAQ: NCNA) reported financial results for the first quarter ended March 31, 2024 and provided an update on its broad clinical development program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, MAY 16, 2024, View Source [SID1234643400]).

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As of March 31, 2024, NuCana had cash and cash equivalents of £12.9 million compared to £17.2 million at December 31, 2023. NuCana continues to advance its numerous clinical programs and reported a net loss of £6.8 million for the quarter ended March 31, 2024, as compared to a net loss of £7.9 million for the quarter ended March 31, 2023. Basic and diluted loss per share was £0.13 for the quarter ended March 31, 2024, as compared to £0.15 per share for the comparable quarter ended March 31, 2023.

"Our focus remains on advancing our innovative ProTide pipeline to develop more efficacious and safer medicines for patients with cancer," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "NUC-3373, a transformation of 5-FU, is currently being investigated in three ongoing clinical studies. Our randomized Phase 2 study (NuTide:323) is now fully enrolled with 182 patients, and compares NUC-3373 in combination with irinotecan, leucovorin and bevacizumab (NUFIRI + bev) with the standard of care, 5-FU in combination with irinotecan, leucovorin and bevacizumab (FOLFIRI + bev) for the second-line treatment of patients with metastatic colorectal cancer. We look forward to announcing initial data from this study in 2024. We also plan to announce additional data from our ongoing Phase 1/2 study (NuTide:302) of NUFIRI + bev and NUFOX + bev in patients with metastatic colorectal cancer this year. Our Phase 1b/2 study (NuTide:303) of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer also remains on track with data readouts expected in 2024."

Mr. Griffith continued: "Moving to NUC-7738, we recently presented exciting data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These data highlighted NUC-7738’s ability to disrupt RNA polyadenylation, leading to profound alterations in the tumor biology of the patients’ cancers. We believe that this finding provides a rationale as to why NUC-7738 plus pembrolizumab has achieved encouraging anti-cancer activity in several patients who were resistant to PD-1 inhibitors. We are evaluating NUC-7738 in an ongoing Phase 1/2 study (NuTide:701) as a monotherapy in patients with advanced solid tumors and in combination with pembrolizumab in PD-1 inhibitor-resistant patients with melanoma. We plan to announce additional data from this study in 2024."

Mr. Griffith concluded, "We look forward to providing updates from all of our ongoing clinical studies this year as we continue working towards our mission of improving treatment outcomes for patients with cancer."

2024 Anticipated Milestones

NUC-3373 (a ProTide transformation of 5-FU)

In 2024, NuCana expects to:

Announce data from the randomized Phase 2 (NuTide:323) study of NUFIRI + bev compared to the standard of care FOLFIRI + bev for the second-line treatment of patients with metastatic colorectal cancer;
Announce data from the Phase 1b/2 (NuTide:302) study of NUFIRI + bev and NUFOX + bev for the second-line treatment of patients with metastatic colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer.
NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In 2024, NuCana expects to:

Announce data from the Phase 2 part of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with melanoma.

On May 16, 2024 Novartis BidCo AG, an (indirect) wholly owned subsidiary of Novartis AG, reported the result of its voluntary public takeover offer (the "Offer") for the shares of MorphoSys AG ("MorphoSys"), including all shares represented by MorphoSys American Depositary Shares ("ADS") (Press release, Novartis, MAY 16, 2024, View Source [SID1234643399]). As of the expiry of the acceptance period at 24:00 hours CEST on 13 May 2024, the Offer has been accepted by approximately 79.6 percent of the total share capital of MorphoSys, including purchases by Novartis BidCo AG outside the Offer for approximately 11.6 percent of the share capital. All conditions of the Offer, including the minimum acceptance threshold of 65%, were fulfilled by the end of the acceptance period. The settlement of the shares tendered during the initial acceptance period is scheduled for 23 May 2024.

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The statutory two-week additional acceptance period for the Offer will commence on 17 May 2024 and end on 30 May 2024 at 24:00 hours CEST and 18:00 hours EDT (also on 30 May 2024). During this time, shareholders who have not tendered their MorphoSys shares, including shares represented by MorphoSys ADS, can still accept the Offer.
With all offer conditions fulfilled, Novartis can now begin the necessary steps to progress the integration of MorphoSys, including full access to pelabresib (CPI-0610), a novel BET inhibitor in combination with ruxolitinib for patients with myelofibrosis. The integration also allows full access to tulmimetostat (CPI-0209), an early-stage investigational dual inhibitor of EZH1 and EZH2 currently being tested in patients with solid tumors or lymphomas, as well as a broad portfolio of partnered assets, some of which are in partnership with Novartis, including ianalumab (VAY736). In the context of the integration Novartis continues to progress the workstreams for implementation of both a delisting of MorphoSys and a domination and profit and loss transfer agreement with MorphoSys.

Georgeson is acting as information agent for Novartis for the Offer. Deutsche Bank is acting as share tender agent and The Bank of New York Mellon is acting as ADS tender agent for the Offer.

The offer document for the Offer and additional information are available at www.novartis.com/investors/morphosys-acquisition. A takeover offer hotline for retail shareholders is available between 9:00-18:00 hours CEST from Monday through Friday at +49 89 38038187 (for German callers) and +44 203 005 6716 (for international callers). A takeover offer hotline for ADS holders is available between 9:00-23:00 hours EDT from Monday through Friday and 12:00-18:00 hours EDT on Saturdays at +1 (866) 356-7344 (for U.S. callers) and +1 (781) 236-4704 (for callers outside the U.S.).

Additional Information and Where to Find it
This communication is neither an offer to purchase nor a solicitation of an offer to sell shares of MorphoSys. The final terms and further provisions regarding the Offer are available in the offer document published by Novartis BidCo AG (formerly known as Novartis data42 AG) (the "Bidder"). The offer document has been approved by the BaFin and has been filed with the U.S. Securities and Exchange Commission (the "SEC"). The solicitation and offer to buy shares of MorphoSys is only being made pursuant the offer document. In connection with the Offer, the Bidder and Novartis AG have filed Tender Offer Statement on Schedule TO with the SEC (together with the offer document, an Offer to Purchase including the means to tender and other related documents, the "Offer Documents"), the management board and supervisory board of MorphoSys have issued a joint reasoned statement in accordance with sec. 27 of the German Securities Acquisition and Takeover Act and MorphoSys has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC (together with the joint reasoned statement, the "Recommendation Statements"). THE MORPHOSYS SHAREHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE OFFER DOCUMENTS AND THE RECOMMENDATION STATEMENTS BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE OFFER. The Offer Documents and the Recommendation Statements will be distributed to all stockholders of MorphoSys in accordance with German and U.S. securities laws. The Tender Offer Statement on Schedule TO and the Solicitation/Recommendation Statement on Schedule 14D-9 are available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting the Bidder or MorphoSys. Free copies of these materials and certain other offering documents are available on the Bidder’s website at www.novartis.com/investors/morphosys-acquisition or by contacting the Bidder’s investor relations department at +41 61 324 7944.

In addition to the Offer to Purchase, including the means to tender and certain other Offer Documents, as well as the Solicitation/Recommendation Statement, MorphoSys and the Bidder will file other information with the SEC. Filings by Novartis AG and the Bidder with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.

In order to reconcile certain areas where German law and U.S. law conflict, Novartis AG and the Bidder have requested and received no-action and exemptive relief from the SEC to conduct the Offer in the manner described in the offer document.

Acceptance of the Offer by stockholders residing outside Germany and the U.S. may be subject to further legal requirements. With respect to the acceptance of the Offer outside Germany and the U.S., no responsibility is assumed for the compliance with such legal requirements applicable in the respective jurisdiction.

On May 16, 2024 NKGen Biotech, Inc. (Nasdaq: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapeutics, reported that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen, will present highlights of the Company’s cryopreserved, autologous, non-genetically modified NK cell therapy product, SNK01, which has demonstrated enhanced cytotoxicity and activating receptor expression for the treatment of neurodegenerative diseases and solid tumors, at the 5th International Cell & Gene Therapy China Summit & Exhibition (CGCS) to be held in Nanjing, China, from May 22–24, 2024 (Press release, NKGEN Biotech, MAY 16, 2024, View Source [SID1234643398]).

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CGCS will showcase exclusive new data in the several areas, including solid tumor treatment, off-the-shelf therapy, innovative cell therapy, AAV gene therapy, affordability of CGT, global cooperation, RNA therapeutics, and CGT commercialization. CGCS 2024 anticipates over 6,000 global attendees, more than 200 exhibitors, greater than 200 world-class speakers from large pharma, innovative biotech, and academia.

NKGen Presentation Details:

Title: Autologous NK Cell Therapy
Session: A: Cell Therapy Focus
Section: A2: Original Innovation in Cell Therapy – Universal and Solid Tumor Treatment
Date and Time: May 23, 2024, at 4:30 PM CST (China Standard Time) UTC/GMT +8

Dr. Song’s presentation will cover a variety of important topics, including industry challenges in manufacturing autologous NK cells at scale, which has been successfully overcome by NKGen’s next-gen CMC manufacturing process in its production of its autologous NK cell therapy product, SNK01. In addition, Dr. Song will discuss the results from SNK01 treatment in combination with either immune checkpoint inhibitors in patients with advanced solid tumors, or, in combination with Erbitux in tyrosine kinase inhibitor-resistant non-small cell lung cancer.

The presentation will also include the scientific rationale and supporting data behind the use of SNK01 in neurodegenerative disease specifically emphasizing the ability of SNK01 to improve levels of amyloid beta, tau, and alpha-synuclein proteins as well as GFAP, NfL, and YKL-40, which are elevated in numerous neurodegenerative diseases including Alzheimer’s, Parkinson’s, Lewy Body Dementia, Frontotemporal Dementia, Multisystem Atrophy, and Progressive Supranuclear Palsy alluding to the potential use of SNK01 to treat these diseases or as a possible prevention in high risk asymptomatic patients with elevated biomarkers.

Previously disclosed data for SNK01 in Alzheimer’s disease and solid tumors can be found on the Scientific Publications page of the Company’s website at View Source

On May 16, 2024 OneChain Immunotherapeutics S.L. (OneChain) and NanoCell Therapeutics Inc. (NanoCell), reported a strategic collaboration to develop a novel in vivo CAR-T therapy targeting B-cell lymphomas (Press release, NanoCell Therapeutics, MAY 16, 2024, View Source [SID1234643397]). This partnership combines OneChain’s advanced CD22 CAR technology with NanoCell’s innovative in vivo CAR-T technology platform, opening a new course for treatment in this disease area with persisting unmet need.

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NanoCell’s non-viral, DNA-based CAR-T technology platform has demonstrated compelling results in pre-clinical proof of concept studies, durable CAR-T expression and robust tumor control. This new approach offers a viable alternative to conventional viral methods, potentially establishing a new standard in the field.

OneChain’s proprietary CD22 CAR molecule was developed and optimized by Professor Pablo Menendez, founder of OneChain and Professor at the Josep Carreras Institute for Leukemia. Preclinical validation of this CD22 CAR has been published in multiple peer-reviewed academic journals1.

"Partnering with NanoCell allows us to integrate our CD22 CAR with their innovative in vivo CAR-T technology, aiming to enhance treatment options for B-cell lymphoma", said Stefanos Theoharis, CEO of OneChain Immunotherapeutics.

"We look forward to collaborating with OneChain Immunotherapeutics, and potentially offering innovative treatments beyond traditional CD19 therapies for patients with B-cell malignancies", added Maurts Geerlings, CEO of NanoCell Therapeutics.

To learn more about our work and stay updated about our latest developments, please visit our websites at View Source and View Source

On May 16, 2024 Monte Rosa Therapeutics, Inc. ("Monte Rosa") (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported the pricing of an underwritten public offering of 10,638,476 shares of its common stock at a public offering price of $4.70 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 10,638,524 shares of common stock at a public offering price of $4.6999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant (Press release, Monte Rosa Therapeutics, MAY 16, 2024, View Source [SID1234643396]). The gross proceeds to Monte Rosa from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $100 million. All of the shares and pre-funded warrants in the offering are to be sold by Monte Rosa. The offering is expected to close on or about May 20, 2024, subject to satisfaction of customary closing conditions.

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The financing was led by Dimension and a life-sciences focused institutional investor, with participation from other new and existing investors.

TD Cowen and Wedbush PacGrow are acting as joint book-running managers for the offering.

The shares and pre-funded warrants are being offered by Monte Rosa pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC) on July 1, 2022 and declared effective by the SEC on July 13, 2022 (File No. 333-266003). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov.

The final prospectus supplement relating to and describing the final terms of the offering will be filed with the SEC and may be obtained, when available, from TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected] or Wedbush Securities Inc., Attn: ECM Department, 600 Montgomery Street, 29th Floor, San Francisco, CA 94111 or via email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 the registration or qualification under the securities laws of any such state or jurisdiction.