BeyondSpring and Leading Cancer Center to Present Poster at 2023 ASCO Annual Meeting

On May 18, 2023 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a global clinical-stage biopharmaceutical company focused on using a groundbreaking technology platform for drug discovery and developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs, reported that the Company and Memorial Sloan Kettering Cancer Center (MSK) will present a poster at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place on June 2 through 6 in Chicago, IL (Press release, BeyondSpring Pharmaceuticals, MAY 18, 2023, View Source;utm_medium=rss&utm_campaign=beyondspring-and-leading-cancer-center-to-present-poster-at-2023-asco-annual-meeting [SID1234631908]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The poster, titled, "​​Plinabulin to shorten neutropenia and improve quality of life peri-autologous hematopoietic cell transplant," will be presented by Dr. Gunjan Shah, MD, MS, Assistant Attending Physician at MSKCC and Principal Investigator of the BeyondSpring-MSKCC pilot trial evaluating Plinabulin in combination with pegfilgrastim in multiple myeloma patients who undergo an autologous hematopoietic cell transplant (AHCT).

Additional presentation details are as follows:

Poster Session Date / Time: Monday, June 5, 2023, at 9 a.m. to 12 p.m. ET
Location: McCormick Place Convention Center, Hall A
Track: Hematologic Malignancies
Abstract / Poster Board No.: 8023 / 15

Legend Biotech Reports First Quarter 2023 Results and Recent Highlights

On May 18, 2023 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported its first quarter 2023 unaudited financial results (Press release, Legend Biotech, MAY 18, 2023, View Source [SID1234631875]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are extremely pleased to announce that we have recently raised $762 million in funding. With this substantial capital infusion, we are poised to embark on a critical chapter in our company’s growth to advance CARVYKTI toward its full potential, and we look forward to presenting the latest data from our CARTITUDE clinical development programs at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) this June," said Ying Huang, Chief Executive Officer of Legend Biotech. Dr. Huang continued, "We would like to extend our deepest gratitude to our investors for their overwhelming support and confidence in our company’s mission and remain committed to creating long-term value for all of our stakeholders."

Financial Results for Quarter Ended March 31, 2023

Cash and Cash Equivalents, Time Deposits, and Short-Term Investments
As of March 31, 2023, prior to giving effect to the registered direct offering, private placements or warrant exercise noted above, Legend Biotech had approximately $854 million of cash and cash equivalents, time deposits, and short-term investments.

Revenue
Total revenue for the three months ended March 31, 2023 was $36.3 million compared to $50.0 million for the three months ended March 31, 2022. Collaboration revenue recognized in the first quarter of 2023 was from CARVYKTI sales primarily in the U.S. License revenue recognized in first quarter of 2022 was due to the achievement of commercial milestone for FDA approval in the U.S. in connection with the license and collaboration agreement (the "Janssen Agreement") with Janssen Biotech, Inc. ("Janssen").

Collaboration Cost of Revenue
Collaboration cost of revenue for the three months ended March 31, 2023 was $35.6 million. Legend Biotech did not have any collaboration cost of revenue in the three months ended March 31, 2022. The $35.6 million is a combination of Legend’s portion of collaboration cost of sales in connection with collaboration revenue under the Janssen Agreement along with expenditures to support the manufacturing capacity expansion which cannot be capitalized.

Research and Development Expenses
Research and development expenses for the three months ended March 31, 2023 were $84.9 million compared to $81.5 million for the three months ended March 31, 2022. This increase of $3.4 million was primarily due to higher patient enrollment for Phase 3 clinical trials for cilta-cel in the first quarter of 2023.

Administrative Expenses
Administrative expenses for the three months ended March 31, 2023 were $22.2 million compared to $12.7 million for the three months ended March 31, 2022. The increase of $9.5 million was primarily due to continued investment in building global information technology infrastructure along with non-recurring financial and legal fees related to Legend Biotech’s restatement of its historical financial statements as reported by Legend Biotech in February 2023.

Selling and Distribution Expenses
Selling and distribution expenses for the three months ended March 31, 2023 were $18.0 million compared to $21.3 million for the year three months ended March 31, 2022. This decrease of $3.3 million was primarily due to non-recurring launch expenses incurred in the first quarter of 2022 to support the commercialization in the U.S market.

Other Income and Gains
Other income and gains for the three months ended March 31, 2023 were $8.2 million compared to $1.0 million for the three months ended March 31, 2022. The increase of $7.2 million was primarily due to increase in interest income and gain on investments.

Other Expenses
Other expenses for the three months ended March 31, 2023 were $10.7 million compared to $1.5 million for the three months ended March 31, 2022. The increase was primarily due to unrealized foreign currency exchange loss in the quarter.

Finance Costs
Finance costs for the three months ended March 31, 2023 were $5.1 million compared to $1.0 million for the three months ended March 31, 2022. The increase was primarily due to interest on advance funding, which is interest-bearing borrowings funded by Janssen under the Janssen Agreement and constituted by principal and applicable interests upon such principal.

Fair Value Gain of Warrant Liability
Fair value gain of warrant liability for the three months ended March 31, 2023 was $20.0 million caused by changes in the fair value of a warrant that Legend Biotech issued to an institutional investor through a private placement transaction in May 2021 with an initial fair value of $81.7 million at the issuance date. The warrant was assessed as a financial liability with a fair value of $47.0 million as of March 31, 2023. On May 12, 2023, Legend Biotech announced that the warrant had been exercised in full.

Loss for the Period
For the three months ended March 31, 2023, net loss was $112.1 million, or $0.34 per share, compared to a net loss of $32.3 million, or $0.10 per share, for the three months ended March 31, 2022.

Adicet Bio Presents Positive Preclinical Data on ADI-270 at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting

On May 18, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported preclinical data highlighting ADI-270, an armored allogeneic "off-the-shelf" gamma delta CAR (chimeric antigen receptor) T cell therapy candidate targeting CD70+ cancers, at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) taking place from May 16-20, 2023, in Los Angeles, CA (Press release, Adicet Bio, MAY 18, 2023, View Source [SID1234631873]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We believe that ADI-270, combined with a third generation CAR and armoring technologies designed to improve persistence and resilience within the TME, may be able to overcome multiple barriers for realizing efficacy for cell therapies in solid tumors. Together with both innate and adaptive immune targeting and tumor infiltration, we believe ADI-270 can potentially improve clinical outcomes for patients," said Dr. Blake Aftab, Ph.D., Chief Scientific Officer of Adicet. "These findings provide critical groundwork to support the continued clinical development of ADI-270 as a potentially meaningful therapeutic option."

In this study, gamma delta T cells modified to express CD70 CAR were successfully generated and expanded without evident hindrances from CD70-mediated fratricide in the process. Data being presented included the following findings:

ADI-270 demonstrated preclinical proof-of-concept as an armored allogeneic gamma delta CAR T cell therapy candidate utilizing the CD27 natural receptor in a third generation CAR format for targeting CD70-positive cancers.
ADI-270 gamma delta 1 CAR T cells expressed a predominant naïve-like memory phenotype with potent in vitro cytotoxicity and production of proinflammatory cytokines against CD70+ tumor cell lines via multiple mechanisms.
ADI-270 showed significant inhibition of tumor growth in CD70+ tumor cell lines, which was maintained in the presence of TGF beta inhibitory factor, and exhibited improved resistance to killing by host T cell rejection.
ADI-270 also demonstrated marked biodistribution and infiltration into solid tumor models of renal cell carcinoma.
Details for the poster presentations are as follows:

Title: ADI-270: An Armored Allogeneic "Off-the-Shelf" CAR gamma delta T Cell therapy Targeting CD70+ Cancers

Abstract Number: 1023
Poster Session: Thursday Poster Session
Date & Time: May 18, 2023 at noon

Oncomatryx acquires Tube Pharmaceuticals GmbH to consolidate its pioneering pipeline of ADCs targeting the tumor microenvironment

On May 18, 2023 Oncomatryx reported that it has acquired Tube Pharmaceuticals GmbH, the developer of the Cytolysin toxic payload (Press release, Oncomatryx, MAY 18, 2023, View Source [SID1234631872]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The multimillion €uros transaction is a strategic decision by Oncomatryx that will foster its leadership in the field of ADCs targeting the tumor microenvironment. It culminates a decade-long alliance between Oncomatryx and Tube that has already rendered clinical-stage ADCs targeting the Tumor Microenvironment. Oncomatryx’s pioneering drug OMTX705, which incorporates the cytolysin toxic payload developed by Tube, is a first-in-class antibody-drug conjugate targeting cancer-associated fibroblasts. OMTX705 has shown complete tumor regression in many PDx and syngeneic murine models, as well as an unbeatable safety profile in rats and monkeys. A FIH multiple expansion cohort clinical trial targeting metastatic solid tumors is ongoing in seven hospitals in Spain and USA.

Oncomatryx now owns the comprehensive portfolio of cytolysins synthesized by Tube and the cutting-edge technology developed in its laboratories. Led by Dr. Wolfgang Richter, the Austrian company has more than 15 years of experience and has positioned itself as a top-level benchmark in the generation of novel ADC payloads.

This significant step forward in Oncomatryx internationalization strategy will also enhance its chemistry department thanks to the incorporation of Dr. Richter, who will drive the company’s efforts to continue developing novel drugs that attack the tumor microenvironment.

According to Laureano Simon, founder of Oncomatryx, "This strategic agreement is a significant milestone for Oncomatryx. It consolidates our technological portfolio and our commitment to target the microenvironment of the most invasive tumors. In addition, bringing Dr. Richter’s knowledge and experience into our team will open up even more possibilities in the design and development of novel ADCs."

It is worth noting that over the past 10 years, Oncomatryx has been involved in the development of innovative medicines in collaboration with prestigious universities, hospitals, and research centers in Europe and USA, such as the University of Stuttgart, the University of Torino, CIC-Biogune, the National Center for Oncological Research, Onkologikoa, Harvard University and the MD Anderson Cancer Center, among others.

LadRx Announces Reverse Stock Split Effective as of May 17, 2023

On May 18, 2023 LadRx Corporation (OTCQB: LADX) ("LadRx" or the "Company"), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, reported that its previously announced reverse stock split of its common stock at a ratio of 1 post-split share for every 100 pre-split shares became effective at 5:00 a.m. PDT on Wednesday, May 17, 2023 (Press release, LadRx, MAY 18, 2023, View Source [SID1234631871]). Under FINRA rules, the Company’s common stock will be traded on the OTC Capital Markets under the symbol "LADXD" on a split-adjusted basis for the first 20 trading days, after which the Company’s stock will trade under its symbol "LADX". The new CUSIP number for the common stock following the reverse stock split is 232828707.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!