On June 18, 2024 Day One Biopharmaceuticals (Nasdaq: DAWN) ("Day One" or the "Company"), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported it has entered into an exclusive licensing agreement (the Agreement) with MabCare Therapeutics (MabCare) for MTX-13, a novel ADC targeting protein-tyrosine kinase 7 (PTK7) (Press release, Day One, JUN 18, 2024, View Source [SID1234644421]). Pursuant to the terms of the Agreement, Day One has exclusive rights to develop, manufacture, and commercialize MTX-13 worldwide, excluding Greater China.

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In April 2024, the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for MTX-13, which going forward will be identified as DAY301. In pre-clinical studies, DAY301 showed antitumor activity in a wide range of solid tumors.

"Our priorities for 2024 are to successfully launch OJEMDATM (tovorafenib), to advance our existing programs and to expand our pipeline by in-licensing clinical-stage assets that have the potential to transform outcomes for patients of all ages living with cancers," said Jeremy Bender, Ph.D., chief executive officer of Day One. "We are excited by the opportunity presented by DAY301, and we believe we have the right team in place to develop the program to its full potential."

DAY301 targets PTK7, a highly-conserved, catalytically inactive transmembrane protein that is overexpressed in multiple adult cancers, including esophageal, ovarian, lung, and endometrial cancer, as well as pediatric cancers such as neuroblastoma, rhabdomyosarcoma and osteosarcoma. PTK7 has limited expression in normal tissues or organs, making it an attractive target for therapeutic development.

"The addition of DAY301 to our pipeline strategically fits our mission of advancing both pediatric and adult medicines in areas of unmet need with equal urgency," said Dr. Samuel Blackman, co-founder and head of research and development at Day One. "We believe the linker-payload technology embodied in DAY301 will overcome the limitations of earlier PTK7-targeted ADCs, giving us a potential first-in-class drug against a clinically-validated target. We are excited to add this program to Day One and will look to enter the clinic in the coming months."

Under the terms of the licensing agreement, MabCare will receive $55 million upfront, and is eligible to receive an additional $1.152 billion in development, regulatory and commercial success-based milestones, plus low-to-mid single-digit royalties on net sales outside of Greater China. Day One expects the first patient to be dosed in the Phase I study in the fourth quarter of 2024 or first quarter of 2025.

On June 18, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will participate in a fireside chat at the H.C. Wainwright 2nd Annual Immune Cell Engager Virtual Conference on Tuesday, June 25, 2024, at 2:00 p.m. ET (Press release, CytomX Therapeutics, JUN 18, 2024, View Source [SID1234644420]).

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A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conference.

On June 17, 2024 BioNTech and its partner MediLink Therapeutics (Suzhou) Co., Ltd ("MediLink") reported that the U.S. Food and Drug Administration ("FDA") has placed a partial clinical hold on the multicenter, open-label, first-in-human Phase 1 clinical (NCT05653752) trial sponsored by MediLink that evaluates the early-stage antibody-drug conjugate ("ADC") product candidate BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor ("EGFR")-mutated non-small cell lung cancer ("NSCLC") or HR+/HER2-negative breast cancer (Press release, BioNTech, JUN 17, 2024, View Source [SID1234645735]). The partial hold affects the enrollment of new patients in the trial in the U.S.

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The FDA has shared with MediLink concerns that BNT326/YL202 may, at higher doses, expose human subjects to unreasonable and significant risk of illness or injuries. In order to address the FDA requests, certain steps need to be taken, including reviewing clinical and safety data, sharing available pharmacological data with the Agency and providing additional information in the investigators brochure regarding the safety findings including grade 5 adverse events observed in studies YL202-INT-101-01 and YL202-CN-201-01. MediLink has taken actions to pause enrollment of new patients in the U.S. and address the FDA requirements.

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 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, reported that it will present and host institutional investor meetings at the Stifel 2024 Cell Therapy Forum (Press release, Immix Biopharma, JUN 17, 2024, View Source [SID1234644388]).

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Stifel 2024 Cell Therapy Forum – Immix Biopharma

Date: Tuesday, July 9, 2024
Presentation: Immix Biopharma to present
Location: Virtual
Investor Meetings: The IMMX Team will be available for institutional investor meetings during the conference.