On May 01, 2024 Beyond Cancer, Ltd., a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, reported being selected to present on the clinical development program of its Ultra-High Concentration Nitric Oxide (UNO) at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31 – June 4, 2024 at the McCormick Place Convention Center in Chicago, Illinois (Press release, Beyond Air, MAY 1, 2024, View Source [SID1234642535]). In addition, the Company will host a KOL event that will highlight the ongoing clinical development of UNO (additional details below).

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Company Sponsored Event:
Beyond Cancer will host an event on May 31, 2024 featuring Key Opinion Leaders who will discuss the clinical development program for UNO, including new data from the Phase 1 trial. The event will take place at the Hyatt Regency McCormick Place, from 6:00 p.m. – 8:00 p.m. Central Time.

To learn more and register for the company sponsored event please contact Matt Johnson at [email protected].

ASCO Annual Meeting Presentations:

Title: A phase 1, multi-center, safety, feasibility, and preliminary efficacy study evaluating a single dose of UNO101 in relapsed or refractory, unresectable, primary, or metastatic cutaneous and subcutaneous malignancies
Session Date and Time: Saturday, June 1, 2024 at 9:00 a.m. – 12:00 p.m. Central Time
Session Type and Title: Poster Presentation/Developmental Therapeutics – Immunotherapy
Abstract Number: TPS2686
Authors: Frederick M. Dirbas, Amichay Meirovitz, David Greenberg, Edith Dekel, Gavin Choy, Jedidiah M. Monson

Title: Effect of UNO101 on tumor microenvironment in relapsed or refractory, unresectable, primary, or metastatic cutaneous and subcutaneous malignancies
Session Type and Title: Publication Only; New Targets and New Technologies
Abstract Number: e14575
Authors: Amichay Meirovitz, David Greenberg, Mark Pegram, Jedidiah M. Monson

A copy of the ePublication can be accessed on the Science and Technology page of the Company’s website after May 23, 2024 at 5:00 p.m. ET when made available by ASCO (Free ASCO Whitepaper).

About Nitric Oxide

Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens.

About UNO Therapy for Solid Tumors

Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease. In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models. Beyond Cancer, Ltd. believes that UNO has the potential to prevent relapse or metastatic disease with as little as a single 5-minute treatment and with limited toxicity or off-target effects.

On May 1, 2024 OmniAb, Inc. (NASDAQ: OABI) reported that management will be participating in five investor conferences during the month of May (Press release, OmniAb, MAY 1, 2024, View Source [SID1234642533]).

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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

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RBC Capital Markets Global Healthcare Conference, May 14-15 at the InterContinental Barclay Hotel in New York City. Management will participate in a fireside chat on Wednesday, May 15th at 11:30 a.m. Eastern time and will hold one-on-one meetings with investors. A live and archived webcast of the fireside chat will be available in the Investors section of OmniAb’s website.

H.C. Wainwright 2nd Annual BioConnect Investor Conference at Nasdaq, May 20 in New York City. Management will participate in a fireside chat on Monday, May 20th at 9:30 a.m. Eastern time and will hold one-on-one meetings with investors.

Benchmark 4th Annual Virtual Healthcare House Call 1×1 Investor Conference, May 21-22. Management will participate in a virtual call on Wednesday, May 22nd at 3:00 p.m. Eastern time and will hold one-on-one virtual meetings with investors.

Craig-Hallum 21st Annual Institutional Investor Conference, May 29 at The Depot Renaissance Minneapolis Hotel. Management will be holding one-on-one and small group meetings on Wednesday, May 29th with investors.

2024 Leerink Partners Healthcare Crossroads Conference, May 28-30 at the Omni Barton Creek Resort & Spa in Austin, Texas. Management will participate in a fireside chat on Thursday, May 30th at 8:00 a.m. Central time and will hold one-on-one meetings with investors.

On May 1, 2024 Alkermes reported first quarter 2024 results (Press release, Alkermes, MAY 1, 2024, View Source [SID1234642532]).

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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

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On May 1, 2024 United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported its financial results for the quarter ended March 31, 2024 (Press release, United Therapeutics, MAY 1, 2024, View Source [SID1234642530]). Total revenues in the first quarter of 2024 grew 34 percent year-over-year to $677.7 million, compared to $506.9 million in the first quarter of 2023.
"The first quarter of 2024 represents another quarter of record revenue and double-digit year-over-year revenue growth," jointly said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer and Michael Benkowitz, President and Chief Operating Officer. "That growth, coupled with our upcoming clinical reads, puts us in a unique position in the biotech industry: a company with a solid and growing commercial foundation, near-term clinical catalysts, and the potential to provide an unlimited supply of tolerable, transplantable organs."
"Our distinctive commercial and clinical profile, alongside our solid balance sheet and cash flow potential, makes United Therapeutics a compelling investment opportunity," said James Edgemond, Chief Financial Officer and Treasurer. "That’s why we implemented a $1 billion accelerated share repurchase that concretely demonstrates our belief in our near-term and long-term potential, despite potential competition emerging this year."

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On May 1, 2024 TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) reported its financial results for the first quarter of 2024, along with recent company developments (Press release, TG Therapeutics, MAY 1, 2024, View Source [SID1234642529]).

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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

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "We were extremely pleased with the strong sales of just over $50 million in BRIUMVI U.S. net revenue for the first quarter of 2024, which was ahead of our guidance. We believe this strong momentum will continue to build throughout 2024 and are pleased to update our yearly guidance to $270 to $290 million in BRIUMVI U.S. net revenue in 2024." Mr. Weiss continued, "We are also pleased to be making strides towards our clinical goals for the year which include enhancing the convenient dosing of IV BRIUMVI, developing a subcutaneous form of BRIUMVI, moving BRIUMVI into additional indications beyond MS, and advancing our recent pipeline addition, azer-cel, an allogeneic CAR T, into clinical development."

Recent Highlights & Developments

United States (U.S.) Commercialization of BRIUMVI(ublituximab-xiiy)

BRIUMVI U.S. net product revenue of $50.5 million for the first quarter of 2024, representing >25% quarter over quarter growth
Approximately 4,450 BRIUMVI new patient prescriptions received by the TG Therapeutics hub since launch, including more than 1,250 in the first quarter of 2024, from approximately 800 healthcare providers at approximately 450 centers
Awarded a national contract with the Department of Veterans Affairs (VA) for BRIUMVI to be the preferred agent listed on the VA National Formulary for anti-CD20 antibody indications for patients with relapsing forms of multiple sclerosis
European Commercialization of BRIUMVI

Launched BRIUMVI in the first European country, Germany, with our partner, Neuraxpharm Group (Neuraxpharm)
General Business

Presented updated data from the ENHANCE Phase 3b trial evaluating patients who switch from another CD20 antibody to BRIUMVI at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum
Obtained three additional patents from the United States Patent and Trademark Office (USPTO) for BRIUMVI, extending patent protection through 2042
Entered into a global license agreement with Precision BioSciences, Inc. (Precision) for the development and commercialization of Precision’s allogeneic CD19 CAR T therapy program, azercabtagene zapreleucel (azer-cel), for the treatment of autoimmune disorders and all other non-oncology indications
2024 Updated Target U.S. BRIUMVI Guidance

Q2 2024 target BRIUMVI U.S. net product revenue of approximately $65 million
Updating BRIUMVI U.S. net product revenue target to approximately $270 million to $290 million for the full year 2024 (prior guidance of $220 to $260 million for full year 2024)
2024 Development Pipeline Anticipated Milestones

Commence clinical development of subcutaneous BRIUMVI
Commence a clinical trial evaluating BRIUMVI in an additional autoimmune disease outside of multiple sclerosis (MS)
Commence a clinical trial evaluating azer-cel in autoimmune disease
Present data from the ENHANCE Phase 3b CD20 switch trial at multiple conferences throughout the year
Financial Results for First Quarter 2024

Product Revenue, Net: Product revenue, net was approximately $50.5 million for the three months ended March 31, 2024, compared to $7.8 million for the three months ended March 31, 2023. Product revenue, net for both the three months ended March 31, 2024 and March 31, 2023, consisted of net product sales of BRIUMVI in the United States.
License, milestone, royalty and other revenue: License, milestone, royalty and other revenue was approximately $13.0 million and less than $0.1 million for the three months ended March 31, 2024 and March 31, 2023, respectively. License, milestone, royalty and other revenue for the three months ended March 31, 2024 is predominantly comprised of a $12.5 milestone payment under the Neuraxpharm Commercialization Agreement for the first key market commercial launch of BRIUMVI in the European Union.
R&D Expenses: Total research and development (R&D) expense was $32.7 million for the three months ended March 31, 2024, compared to $15.9 million for the three months ended March 31, 2023. The increase in R&D expense during the three months ended March 31, 2024, was primarily attributable to license and milestone expense of $8.8 million related to the license agreement with Precision, as well as additional manufacturing and development costs incurred in connection with our ublituximab subcutaneous development work during the period.
SG&A Expenses: Total selling, general and administrative (SG&A) expense was $34.6 million for the three months ended March 31, 2024, compared to $28.1 million during the three months ended March 31, 2023. The increase was primarily due to the scale-up of the BRIUMVI commercial launch, including personnel and consultants, during the three months ended March 31, 2024.
Net Loss: Net loss was $10.7 million for the three months ended March 31, 2024, compared to a net loss of $39.2 million for the three months ended March 31, 2023.
Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $209.8 million as of March 31, 2024. We anticipate that our cash, cash equivalents and investment securities as of March 31, 2024, combined with the projected revenues from BRIUMVI, will be sufficient to fund our planned operations to cash flow positivity based on our current operating plan.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, May 1, 2024, at 8:30 AM ET, to discuss the Company’s financial results from the first quarter, ended March 31, 2024.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for a period of 30 days after the call.