On August 6, 2024 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported recent business progress and financial results for the second quarter ended June 30, 2024 (Press release, Bicycle Therapeutics, AUG 6, 2024, View Source [SID1234645409]).

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"In the second quarter, we continued to demonstrate the ongoing progress of our pipeline and highlight the emerging differentiated profiles of our Bicycle Toxin Conjugates zelenectide pevedotin and BT5528 compared to antibody drug conjugates. As we enter the second half of the year, we look forward to sharing the first set of data updates from our clinical programs at the upcoming ESMO (Free ESMO Whitepaper) Congress," said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics. "Additionally, I am honored to welcome renowned oncology experts from around the world to our Clinical Advisory Board. Their advice and counsel will be critical as we work to develop therapies that can help patients live longer and live well."

Dr. Lee continued: "Bicycle Therapeutics also significantly strengthened our balance sheet in the second quarter through the support of leading healthcare investors. Moreover, we have prioritized our pipeline and streamlined our leadership team to enable us to focus on the clinical programs and research areas that we believe have the highest potential for value creation and align with our strategy to support the long-term growth of our company."

Second Quarter 2024 and Recent Events

Four abstracts accepted for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 being held September 13-17 in Barcelona. Bicycle Therapeutics will present four abstracts containing updated clinical data for zelenectide pevedotin (formerly BT8009) in metastatic urothelial cancer (mUC), BT5528 in advanced solid tumors such as mUC and ovarian, and BT7480 in advanced solid tumors.

In June, the company presented two abstracts at the 2024 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting outlining clinical pharmacokinetics of Bicycle Toxin Conjugate (BTC) molecules zelenectide pevedotin and BT5528 compared to antibody drug conjugate enfortumab vedotin and evaluating the emerging safety profile of both BTC molecules, along with an overview of the company’s ongoing Phase 2/3 Duravelo-2 registrational trial of zelenectide pevedotin in mUC.
Focused research and development (R&D) pipeline on clinical programs and research areas that the company believes have the highest potential to maximize value creation. Activities include:
Prioritizing the clinical development of zelenectide pevedotin and BT5528 in multiple tumor types.
Focusing near-term research efforts on advancing the company’s Bicycle Radionuclide Conjugate (BRC) pipeline and the discovery of next-generation BTC molecules.
Except for BT7480, exploring innovative ways to continue development of the company’s immuno-oncology portfolio, including Bicycle Tumor-targeted Immune Cell Agonist (Bicycle TICA) molecules, through collaboration.
Streamlined leadership team to better align with strategic and pipeline priorities.
Michael Skynner, Ph.D., chief technology officer, has assumed leadership of Bicycle Therapeutics’ discovery research team, and all discovery research activities will be consolidated and moved to the company’s headquarters in Cambridge, UK.
Jennifer Perry, Pharm.D., promoted to chief strategy officer and head of commercial. Since joining Bicycle Therapeutics in August 2022, Ms. Perry has been instrumental in establishing and growing Bicycle Therapeutics’ commercial organization. In this expanded role, she will oversee the company’s corporate and end-to-end portfolio strategy while also fulfilling her existing commercial responsibilities. Ms. Perry has more than 20 years of experience in pharma and biotech, with 15 years in oncology. Her experience spans commercial and medical roles with a focus on go-to-market strategies for launching oncology medicines at GSK, Tesaro, TG Therapeutics and Pharmacyclics.
Nick Keen, Ph.D., chief scientific officer, is transitioning to an advisor role with the company as a distinguished fellow, where he will advise the company as needed. The company also hired Eric Westin, M.D., former vice president of clinical development and translational sciences at ImmunoGen, to an advisor role with the company as a distinguished fellow to help refine the company’s translational and clinical strategy.

Formed new Clinical Advisory Board with distinguished global oncology experts to support the advancement of clinical oncology programs. The company expects that the advisors will provide invaluable guidance and insights for the global clinical development of the company’s clinical programs. Inaugural members include:
Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP, is the chair of Bicycle Therapeutics’ Clinical Advisory Board and Scientific Advisory Board. He leads the Cancer Evolution and Genome Instability Laboratory at the Francis Crick Institute in London. Dr. Swanton’s research is focused on how tumors evolve over space and time, and he has authored over 250 papers developing an understanding of branching evolutionary histories of solid tumors, processes that drive cancer cell-to-cell variation and the impact of cancer diversity on effective immune surveillance and clinical outcome.
Toni K. Choueiri, M.D., is the director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School. Dr. Choueiri and colleagues have made seminal observations that have defined and evolved the treatment of kidney cancer and led to the approval of several therapies. He has over 800 PubMed-indexed publications and is the lead investigator of multiple national and international Phase 1-3 trials in GU cancers.

Sherene Loi, MBBS (Hons), Ph.D., FRACP, FAHMS, is a medical oncologist specialized in breast cancer treatment and a clinician scientist (lab head) with expertise in genomics, immunology and drug development at the Peter MacCallum Cancer Centre in Melbourne, Australia. She is recognized internationally as a leading clinician scientist whose work has led to new insights into the breast cancer immunology field as well as leading international clinical trials in breast cancer immunotherapy. Professor Loi has published over 330 research articles, co-chairs the International Breast Cancer Study Group and is the Inaugural National Breast Cancer Foundation of Australia Endowed Chair. In 2021, she received the Australian Prime Minister’s Frank Fenner Prize for Life Scientist of the Year.

Solange Peters, M.D., Ph.D., is full professor and chair of medical oncology and the chair of the thoracic malignancies program in the Department of Oncology at the University Hospital of Lausanne in Switzerland. She currently oversees teaching and patient care in thoracic malignancies at Lausanne University, and her main fields of interest include new biomarker discovery and validation in preclinical and clinical settings as well as cancer immunotherapy. She is the youngest president of ESMO (Free ESMO Whitepaper), serving for an extended period of 2020-2022. Professor Peters has authored over 500 peer-reviewed manuscripts and book chapters and is associate editor of the Annals of Oncology, deputy editor of Lung Cancer and serves on the editorial board of several other oncology journals. She was the deputy editor of the Journal of Thoracic Oncology for 10 years.

Raised gross proceeds of $555 million in private investment in public equity (PIPE) financing. The PIPE financing, with participation from leading healthcare investors, is expected to extend the company’s financial runway into the second half of 2027. The company plans to use the net proceeds of $544.1 million to fund the continued development of its proprietary pipeline and for other R&D, as well as for general corporate purposes.
Repaid and voluntarily terminated outstanding debt with Hercules. In July 2024, Bicycle Therapeutics announced the repayment of its loan with Hercules Capital, Inc., ahead of its 2025 maturity date, with total payments of $31.9 million, including accrued and unpaid interest, an end-of-term charge and an early repayment fee.
Second Quarter 2024 Financial Results

Cash and cash equivalents were $961.4 million as of June 30, 2024, compared to $526.4 million as of December 31, 2023. The increase in cash and cash equivalents is primarily due to net proceeds from the PIPE financing and share option exercises, offset by cash used in operating activities.
R&D expenses were $40.1 million for the three months ended June 30, 2024, compared to $39.7 million for the three months ended June 30, 2023. The increase in expense of $0.4 million was primarily due to increased clinical program expenses for zelenectide pevedotin development and increased personnel-related expenses, offset by decreased clinical program expenses for Bicycle TICA molecule development, decreased discovery, platform and other expenses and incremental U.K. R&D tax credits.
General and administrative expenses were $15.9 million for the three months ended June 30, 2024, compared to $14.8 million for the three months ended June 30, 2023. The increase of $1.1 million was primarily due to increased personnel-related costs.
Net loss was $39.8 million, or $(0.77) basic and diluted net loss per share, for the three months ended June 30, 2024, compared to net loss of $42.6 million or $(1.41) basic and diluted net loss per share, for three months ended June 30, 2023.

On August 6, 2024 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported an update on its recent corporate progress and reported financial results for the quarter ended June 30, 2024 (Press release, MacroGenics, AUG 6, 2024, View Source [SID1234645425]).

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"We are pleased to have the opportunity to present updated safety and efficacy data from our Phase 2 TAMARACK trial of vobra duo at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "In addition, we recently solidified our cash position with the receipt of $100.0 million in milestones, following the positive Phase 3 top-line results from Incyte’s registrational studies of retifanlimab in both anal and lung cancer."

Updates on Proprietary Investigational Programs

Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below.

B7-H3-Directed Therapies

Vobramitamab duocarmazine (vobra duo) is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation.
The TAMARACK Phase 2 study of vobra duo is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with one prior androgen receptor axis-targeted therapy (ARAT). Participants may have received up to one prior taxane-containing regimen, but no other chemotherapy agents. The TAMARACK study is designed to evaluate vobra duo at two different doses: 2.0 mg/kg or 2.7 mg/kg every four weeks (q4W). MacroGenics completed enrollment of the TAMARACK study in the fourth quarter of 2023, and the study has reached its landmark primary endpoint of 6-month radiographic progression-free survival (rPFS) rate. While mCRPC study participants are no longer being dosed in the study, participants continue to be monitored for adverse events, disease progression and survival.
Updated TAMARACK safety and efficacy data, including the study’s primary endpoint, will be presented in a poster session at the ESMO (Free ESMO Whitepaper) Congress in September 2024. This data will be based on a data cut-off date of July 9, 2024. The abstract submitted to ESMO (Free ESMO Whitepaper) in May was based on an April 12 data cut off. MacroGenics expects to have the mature efficacy findings, including median rPFS, in the second half of 2024 and plans to present the data at a subsequent medical conference.
Following the ESMO (Free ESMO Whitepaper) poster presentation, the Company plans to host a conference call with investors to discuss the TAMARACK data and potential next steps for vobra duo.
MacroGenics continues to enroll a Phase 1/2 dose escalation study of vobra duo in combination with lorigerlimab in patients with various advanced solid tumors. The Company anticipates commencing a dose expansion study of this combination later this year.
MGC026 is a clinical B7-H3-targeting ADC that is site-specifically conjugated to exatecan, a topoisomerase I inhibitor payload developed by Synaffix (a Lonza company). With distinct mechanisms of action, vobra duo and MGC026 may address different cancers, tumor stages, or be used in combination with alternate agents — or potentially with one another — to enhance their clinical utility. A Phase 1 dose escalation study of MGC026 in patients with advanced solid tumors is ongoing.
Lorigerlimab

Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule. In addition to the ongoing study of lorigerlimab in combination with vobra duo mentioned above, MacroGenics is enrolling LORIKEET, a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve mCRPC patients. A total of 150 patients are planned to be treated in the 2:1 randomized study. The current trial design includes a primary study endpoint of rPFS. The Company anticipates completing enrollment of the study in 2024 or early 2025 and providing a clinical update in the first half of 2025.
Emerging ADC Pipeline

MGC028 is a preclinical ADC incorporating an ADAM9-targeting antibody and represents the second MacroGenics ADC molecule that incorporates Synaffix’s novel site-specific linker and topoisomerase I inhibitor-based cytotoxic payload. ADAM9 (a disintegrin and metalloprotease domain 9) is a member of the ADAM family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple cancers, making it an attractive target for cancer treatment. The Company continues to anticipate submitting an investigational new drug (IND) application for MGC028 by the end of 2024 and initiating a Phase 1 clinical study in 2025.
Partnered Programs

MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing. MacroGenics continues to enroll patients in a Phase 1 dose-escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes. Under an October 2022 exclusive option and collaboration agreement, Gilead Sciences, Inc. (Gilead) has the option to license MGD024 at predefined decision points during the Phase 1 study.
ZYNYZ (retifanlimab-dlwr) is a humanized monoclonal antibody targeting PD-1 that the Company licensed to Incyte Corporation (Incyte) in 2017. Incyte recently announced positive Phase 3 top-line results for its registrational studies of retifanlimab in squamous cell carcinoma of the anal canal and non-small cell lung cancer and continues to conduct global studies of retifanlimab across multiple indications.

Subsequent to June 30, 2024, MacroGenics announced the achievement of $100.0 million in milestones from Incyte related to development progress of retifanlimab, following an agreement on July 24, 2024, pursuant to which certain milestones were deemed to have been met. MacroGenics is further eligible to receive up to a total of $210.0 million in remaining development and regulatory milestones and up to $330.0 million in potential commercial milestones from Incyte. MacroGenics receives tiered royalties of 15% to 24% from Incyte on any global net sales of the product and manufactures a portion of Incyte’s global commercial supply of retifanlimab.
Second Quarter 2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities balance as of June 30, 2024, was $140.4 million, compared to $229.8 million as of December 31, 2023. The June 30, 2024 balance did not include the $100.0 million in milestones subsequently received from Incyte.
Revenue: Total revenue was $10.8 million for the quarter ended June 30, 2024, compared to total revenue of $13.1 million for the quarter ended June 30, 2023. The decrease was primarily due to less revenue recognized under the Provention Asset Purchase Agreement and was partially offset by increased revenue from the Company’s collaboration with Gilead and increased contract manufacturing revenue.
R&D Expenses: Research and development expenses were $51.7 million for the quarter ended June 30, 2024, compared to $43.2 million for the quarter ended June 30, 2023. The increase was primarily due to manufacturing and IND-enabling costs related to MGC028.
SG&A Expenses: Selling, general and administrative expenses were $14.4 million for the quarter ended June 30, 2024, compared to $13.7 million for the quarter ended June 30, 2023.
Net Income (Loss): Net loss was $55.7 million for the quarter ended June 30, 2024, compared to net income of $57.5 million for the quarter ended June 30, 2023. Net income for the quarter ended June 30, 2023 included approximately $100.0 million as a component of Other Income related to the sale of the Company’s single-digit royalty interest on global net sales of TZIELD (teplizumab-mzwv) to DRI Healthcare Acquisitions LP in March 2023.
Shares Outstanding: Shares of common stock outstanding as of June 30, 2024 were 62,720,969.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $140.4 million as of June 30, 2024, plus the $100.0 million in milestones subsequently received from Incyte, in addition to projected and anticipated future payments from partners and product revenues should support its cash runway into 2026. The Company’s expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial, the Phase 2 LORIKEET study as well as MacroGenics’ other ongoing clinical and preclinical studies.
No Conference Call

Given the embargoed TAMARACK data being presented at the upcoming ESMO (Free ESMO Whitepaper) presentation, the Company’s management has entered a quiet period and will not be hosting a conference call to discuss its financial results or corporate progress for the quarter ended June 30, 2024. The Company intends to resume its quarterly results conference calls in the future.

On August 6, 2024 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration ("FDA") for the initiation of a Phase I/II clinical study of Silmitasertib (CX-4945) for the treatment of children and young adults with relapsed refractory solid tumors (Press release, Senhwa Biosciences, AUG 6, 2024, View Source [SID1234645442]).

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The principal investigator of this investigator-initiated trial (IIT), Dr. Giselle Saulnier Sholler, is an internationally known pediatric hematology-oncology clinician and researcher. In August 2023, she was invited to serve as the division chief of Pediatric Hematology and Oncology at Penn State Health Children’s Hospital. She brought with her the Beat Childhood Cancer Research Consortium, a worldwide network of more than 55 universities and children’s hospitals dedicated to discovering new therapies and cures for children with cancer.

The research consortium has enrolled more than 1,800 pediatric cancer patients in more than 23 trials, and has previously helped a drug obtain FDA approval for high-risk relapsed neuroblastoma treatments. This phase I/II study is funded by the Four Diamonds Foundation, with Senhwa Biosciences providing the investigational drug, Silmitasertib (CX-4945).

Senhwa Biosciences is planning to apply for Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPD) for Silmitasertib (CX-4945) for the treatment of neuroblastoma. If these designations are granted and the drug is successfully commercialized, the company would obtain a Priority Review Voucher (PRV). The holder of a PRV can designate any future human drug application to receive priority review, potentially shortening the review time to 6 months, which could accelerate the timeline for the company (or its partners) to bring other products to market.

The clinical trial design also includes Ewing’s sarcoma and osteosarcoma, which are common pediatric bone cancers with poor prognoses, representing unmet medical needs.

On August 6, 2024 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, reported its financial results for the second quarter of 2024 (Press release, BioXcel Therapeutics, AUG 6, 2024, View Source [SID1234645410]).

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"We are on track with our business priorities as we focus on bringing BXCL501 to the greatest number of patients in need," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "We are pleased with the progress with our SERENITY and TRANQUILITY programs and our focused market-access strategy for IGALMI. Our confidence in our lead neuroscience asset is underpinned by its broad therapeutic potential across multiple neuropsychiatric conditions and its growing intellectual property portfolio."

Late-Stage Clinical Programs

· SERENITY At-Home* Pivotal Phase 3 Trial: designed to evaluate the safety of a 120 mcg dose of BXCL501 in the at-home setting for agitation associated with bipolar disorders or schizophrenia.

o Recently received feedback on protocol from U.S. Food and Drug Administration (FDA).

· TRANQUILITY In-Care Pivotal Phase 3 Trial: designed to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for agitation associated with Alzheimer’s dementia (AAD).

o Protocol being finalized for planned submission to FDA.

IGALMI (dexmedetomidine) Sublingual film

Post-marketing Requirement (PMR) Study

· Reported positive topline results from PMR study evaluating PRN (as-needed) treatment of IGALMI for agitation associated with bipolar disorders or schizophrenia.

o Study achieved its objective and demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with 180 mcg dose (highest approved dose).

o Although this PMR study was not statistically powered to evaluate repeat dose efficacy, a reduction in agitation was observed for each episode occurring during the seven-day study period, and no serious adverse events were reported following treatment.

Commercialization

· IGALMI net revenue grew 90% in Q2 2024 over Q1 2024 driven by focused market-access strategy and increased contracting with psychiatric care clinics and behavioral health facilities using a small commercial team.

Patent Portfolio

The Company continues to strengthen its intellectual property portfolio for IGALMI.

· Recently received a U.S. Patent and Trademark Office (USPTO) Notice of Allowance for U.S. Patent Application No. 18/526,686 for IGALMI. Once issued by the USPTO, the patent is expected to have an expiration date of January 12, 2043, and will be submitted for listing in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the "Orange Book").

· This is expected to be the 11th listed U.S. patent for IGALMI in the Orange Book.

On August 6, 2024 TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) reported its financial results for the second quarter of 2024, along with recent company developments and provided an update on 2024 revenue guidance (Press release, TG Therapeutics, AUG 6, 2024, View Source [SID1234645426]).

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, "We are pleased to report another quarter of outperformance across all aspects of our business. From a financial standpoint, our second quarter U.S. BRIUMVI net revenues exceeded expectations, leading us to raise our full year guidance. On the R&D side, we also had an exciting quarter with the first patients now treated with subcutaneous ublituximab in a newly launched Phase 1 study and clearance of our IND for azer-cel, our allogeneic "off-the-shelf" CD19 CAR-T, for patients with progressive MS." Mr. Weiss continued, "We are also excited to announce our new $250 million credit facility with HealthCare Royalty and Blue Owl Capital that enables us to accelerate the initiation of a share repurchase program and pay down our current debt, while preserving our current cash to continue building our commercial infrastructure, ramping up our marketing efforts, and investing in our R&D programs. We look forward to continuing the positive momentum into the second half of 2024."

Recent Highlights & Developments

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

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BRIUMVI U.S. net product revenue of $72.6 million for the second quarter of 2024, representing >350% growth over the second quarter of 2023

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Approximately 5,850 BRIUMVI new patient prescriptions received by the TG Therapeutics hub since launch, from approximately 950 healthcare providers at approximately 525 centers, including more than 1,400 prescriptions received in the second quarter of 2024

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Awarded a national contract with the Department of Veterans Affairs (VA) for BRIUMVI to be the preferred anti-CD20 agent listed on the VA National Formulary for patients with relapsing forms of multiple sclerosis (RMS)

Development Updates & General Business

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Initiated a phase 1 clinical trial evaluating subcutaneous ublituximab in RMS, with the first patients now dosed

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Received clearance by the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application for azer-cel in progressive forms of multiple sclerosis (MS)

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Obtained three additional patents from the United States Patent and Trademark Office (USPTO) for BRIUMVI, extending patent protection through 2042

Corporate Finance Updates

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Established a new 5-year, $250 million credit facility with HealthCare Royalty and Blue Owl Capital, set to mature in 2029, primarily to repay $107 million in outstanding debt and accrued interest, which was set to mature in multiple tranches from mid-2025 to January 2026, and to fund the buyback of up to $100 million of currently outstanding shares of the Company’s common stock. The remainder will be available for working capital purposes, providing the Company with additional operational flexibility.

2024 Updated Target U.S. BRIUMVI Guidance

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Updating BRIUMVI U.S. net product revenue target to approximately $290 to $300 million for the full year 2024 (prior guidance of $270 to $290 million for full year 2024)

Remaining 2024 Development Pipeline Anticipated Milestones

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Study BRIUMVI in an additional autoimmune disease outside of MS

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Commence a clinical trial evaluating azer-cel in autoimmune diseases, starting with progressive MS

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Present additional data from the ENHANCE Phase 3b CD20 switch trial

Financial Results for Second Quarter 2024

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Product Revenue, net: Product revenue, net was approximately $72.6 million and $123.1 million for the three and six months ended June 30, 2024, respectively, compared to $16.0 million and $23.8 million for the three and six months ended June 30, 2023, respectively. Product revenue, net for both the three and six months ended June 30, 2024 and 2023, consisted of net product sales of BRIUMVI in the United States.

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License, milestone, royalty and other revenue: License, milestone, royalty and other revenue was approximately $0.9 million and $13.9 million for the three and six months ended June 30, 2024, respectively, compared to less than $0.1 million for both the three and six months ended June 30, 2023, respectively. License, milestone, royalty and other revenue for the six months ended June 30, 2024 is predominantly comprised of a $12.5 million milestone payment under the Neuraxpharm Commercialization Agreement for the first key market commercial launch of BRIUMVI in the European Union (EU) which occurred in the first quarter of 2024.

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R&D Expenses: Total research and development (R&D) expense was approximately $17.6 million and $50.3 million for the three and six months ended June 30, 2024, respectively, compared to $28.1 million and $44.0 million for the three and six months ended June 30, 2023, respectively. The decrease in R&D expense during the three months ended June 30, 2024 was primarily attributable to reduced clinical trial related expense and license milestones incurred during the period ended June 30, 2024. The increase in R&D expense during the six months ended June 30, 2024 was primarily attributable to license and milestone expense related to the license agreement with Precision BioSciences, Inc., as well as additional manufacturing and development costs incurred in connection with our ublituximab subcutaneous development work during the period.

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SG&A Expenses: Total selling, general and administrative (SG&A) expense was approximately $38.8 million and $73.4 million for the three and six months ended June 30, 2024, respectively, compared to $30.7 million and $58.8 million for the three and six months ended June 30, 2023, respectively. The increase in both periods was primarily due to the scale-up of the BRIUMVI commercial launch, including personnel.

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Net Income (Loss): Net income (loss) was $6.9 million and $(3.8) million for the three and six months ended June 30, 2024, respectively, compared to a net loss of $(47.6) million and $(86.8) million for the three and six months ended June 30, 2023, respectively.

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Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $217.3 million as of June 30, 2024, which excludes any increase in cash associated with the new $250 million credit facility. We anticipate that our cash, cash equivalents and investment securities as of June 30, 2024, combined with the projected revenues from BRIUMVI, will be sufficient to fund our business based on our current operating plan.

CONFERENCE CALL INFORMATION
The Company will host a conference call today, August 6, 2024 at 8:30 AM ET to discuss the Company’s financial results from the second quarter ended June 30, 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.

ABOUT BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in the EU and UK for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

A list of authorized specialty distributors can be found at www.briumvi.com.

IMPORTANT SAFETY INFORMATION

Contraindications: BRIUMVI is contraindicated in patients with:

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Active Hepatitis B Virus infection

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A history of life-threatening infusion reaction to BRIUMVI

WARNINGS AND PRECAUTIONS

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56%, compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3%, respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JC virus infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients, compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.

The full Summary of Product Characteristics approved in the European Union (EU) for BRIUMVI can be found here Briumvi | European Medicines Agency (europa.eu).

ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1