On February 28, 2023 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the fourth quarter and year ended December 31, 2022, and recent company developments (Press release, TG Therapeutics, FEB 28, 2023, View Source [SID1234627857]).

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "2022 was a pivotal year for TG with the approval of BRIUMVI for relapsing forms of Multiple Sclerosis, and 2023 is off to an exciting start with the commercial launch of BRIUMVI. Our teams are hard at work introducing BRIUMVI to the MS community and while we are only 4 weeks into the launch, we are encouraged by the early feedback from providers, payors and advocates." Mr. Weiss continued, "Our highest priority is our commitment to patients and to ensure that patients who want BRIUMVI will have access to BRIUMVI. We look forward to building on the foundation we are developing in this early launch phase and extending it throughout 2023 and beyond."

2022 Highlights & Recent Developments

● U.S. Food and Drug Administration (FDA) approved BRIUMVI (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
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Commercially launched BRIUMVI making it available for patients and physicians.

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Presented additional data, including new analyses, from the ULTIMATE I and II Phase 3 trials at the 2022 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and at the 2023 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum.

Key Objectives for 2023

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Execute a strong commercial launch of BRIUMVI in RMS

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Obtain broad payor coverage for BRIUMVI

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Continue to present additional data from the ULTIMATE I & II Phase 3 trials of BRIUMVI in RMS

Financial Results for the Fourth Quarter and Full Year 2022

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Product Revenue, net: Product revenue, net was approximately zero and $2.6 million for the three and twelve months ended December 31, 2022. Net product revenues during the year represent U.S. sales of UKONIQ, which received approval in February of 2021 and was withdrawn from the U.S. market effective May 31, 2022.

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R&D Expenses: Total research and development (R&D) expense was $29.6 million and $125.4 million for the three and twelve months ended December 31, 2022, compared to $62.6 million and $222.6 million for the three and twelve months ended December 31, 2021. The decrease in R&D expense is primarily attributable to reduced clinical trial related expenses, license milestones and manufacturing expense, decreased headcount and lower fees paid to consultants and outside service providers, as well as a decrease in non-cash compensation R&D expense during the twelve months ended December 31, 2022 over the comparable period in 2021.

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SG&A Expenses: Total selling, general and administrative (SG&A) expense was $22.5 million and $70.0 million for the three and twelve months ended December 31, 2022, and $32.4 million and $128.1 million for the three and twelve months ended December 31, 2021. The decrease was primarily attributable to reduced other selling, general and administrative costs as a result of our withdrawal of UKONIQ and decreased headcount during the period ended December 31, 2022, as well as decreased non-cash compensation G&A expense during the twelve months ended December 31, 2022 over the comparable period in 2021.

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Net Loss: Net loss was $53.0 million and $198.3 million for the three and twelve months ended December 31, 2022, compared to $93.3 million and $348.1 million for the three and twelve months ended December 31, 2021. Excluding non-cash compensation, the net loss for the three and twelve months ended December 31, 2022 was approximately $41.9 million and $179.2 million, compared to a net loss of $79.0 million and $286.8 million for the three and twelve months ended December 31, 2021.

● Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $174.1 million as of December 31, 2022. We anticipate that our cash, cash equivalents and investment securities as of December 31, 2022, combined with the $45.0 million of available capacity under our existing term loan facility and projected revenues, will be sufficient to fund the Company’s planned operations into mid-2024.

CONFERENCE CALL INFORMATION

The Company will host a conference call today, February 28, 2023, at 8:30 AM ET, to discuss the Company’s fourth quarter and year-end 2022 financial results.

In order 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 replay at www.tgtherapeutics.com, for a period of 30 days after the call.

On February 28, 2023 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors reported financial results and business highlights for the fourth quarter and year ended December 31, 2022 (Press release, Lyell Immunopharma, FEB 28, 2023, View Source [SID1234627856]).

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"Lyell continued to gain momentum in 2022 with the initiation of two Phase 1 clinical trials for our wholly-owned CAR T cell and TIL product candidates, and we head into 2023 with a goal of accelerating this momentum to generate clinical data from these trials as rapidly as possible," said Lynn Seely, M.D., Lyell’s President and CEO. "We continued to invest in our innovative reprogramming technologies and recently announced two product candidates in preclinical development that incorporate new stackable technologies designed to further enhance T-cell potency and cytotoxicity to defeat solid tumors. Our strong financial position with cash runway into 2026 positions us to demonstrate the value of our two lead clinical programs that target solid tumors with large unmet needs while continuing to invest in and develop our innovative pipeline."
Fourth Quarter Updates and Recent Business Highlights
Lyell is advancing four wholly-owned product candidates: two product candidates, LYL797 and LYL845, are in Phase 1 clinical development and two additional product candidates, LYL119 and a TIL product candidate incorporating novel genetic and epigenetic reprogramming technologies, are in preclinical development.
LYL797 – A ROR1 CAR T-cell product candidate genetically reprogrammed using c-Jun and epigenetically reprogrammed using Lyell’s proprietary Epi-RTM manufacturing protocol, designed for differentiated potency and durability
•Enrollment in the Phase 1 clinical trial of LYL797 is ongoing. Initial clinical data from the Phase 1 trial of LYL797 are expected in the first half of 2024.
•Presented nonclinical data at the American Association of Cancer Research 2022 Annual Meeting characterizing LYL797 and demonstrating that Lyell’s c-Jun overexpression and Epi-R reprogramming technologies can overcome barriers of T-cell exhaustion and lack of durable stemness in engineered T cells using a set of in vitro and in vivo models, including an aggressive syngeneic mouse tumor model and a xenograft lung cancer model.
•Presented nonclinical data demonstrating LYL797 showed improved expansion and anti-tumor activity and prolonged survival compared to conventional ROR1 CAR T cells in an established human ROR1-positive H1975 mouse xenograft model at the American Society of Gene and Cell Therapy Annual Meeting.
LYL119 – An innovative ROR1 CAR T-cell product designed for enhanced cytotoxicity
•LYL119 incorporates four of Lyell’s stackable reprogramming technologies, including two novel technologies – a genetic knockout of NR4A3 (NR4A3-KO) and Stim-R. These technologies, which are complementary to c-Jun and Epi-R, are designed to further improve the anti-tumor potency and durability of T-cells.
•An IND for LYL119 is expected to be submitted in the first half of 2024.

•Presented nonclinical data demonstrating that the combination of two genetic reprogramming technologies, NR4A3 gene knockout and c-Jun overexpression, enhances the functional activity of ROR1 CAR T cells as shown by higher levels of cytokine production, increased CAR T-cell persistence and reduced surface expression of inhibitory receptors after repetitive antigen stimulation, as well as significant improvement in tumor control in vivo at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2022 Annual Meeting (SITC 2022).
•Presented nonclinical data at SITC (Free SITC Whitepaper) 2022 demonstrating that Lyell’s proprietary Stim-R epigenetic reprogramming technology, which enables precise control and optimized delivery of activation molecules during T-cell production, generates potent CAR T-cell product candidates with increased cell proliferation and persistence, as well as improved tumor control in vivo.
LYL845 – A novel epigenetically reprogrammed TIL product candidate designed for differentiated potency and durability
•Announced clearance of the IND for LYL845 in October 2022; enrollment in the Phase 1 clinical trial for LYL845 is ongoing. Initial clinical data from the Phase 1 trial of LYL845 are expected in 2024.
•Presented nonclinical data at SITC (Free SITC Whitepaper) 2022 demonstrating the ability of Lyell’s Epi-R technology to successfully expand TIL in both hot and cold tumors and to retain qualities linked with anti-tumor functionality and improved outcomes in previous TIL clinical trials. These qualities present in Lyell’s Epi-R TIL include a greater proportion of CD8+ T cells, enrichment for T cells with stem-like profiles, better metabolic fitness and preserved polyclonality compared to control TIL preparations.
•Presented bioinformatic analyses, including comprehensive analyses of transcriptomic profiles, polyclonality and prediction of tumor-reactive T cell clones in Lyell’s LYL845 product candidate, at SITC (Free SITC Whitepaper) 2022. These analyses demonstrated that LYL845 expanded at clinical scale using Epi-R technology remained highly polyclonal and preserved approximately 94% of the predicted tumor reactive clones. Further, the preserved predicted tumor reactive clones in LYL845 have increased stemness and reduced exhaustion‑associated genes compared to TIL products derived from the standard process.
Corporate and Operational Updates
•In December, Lynn Seely, M.D., a member of the company’s board since May 2021 and former President and CEO of Myovant Sciences, was named President and CEO. Dr. Seely has extensive biopharmaceutical leadership experience with a track record of success building companies and developing new medicines in oncology and women’s health.
•In September, Rahsaan W. Thompson was named Chief Legal Officer. Mr. Thompson is a biopharmaceutical industry veteran with more than 20 years of experience with development stage and commercial companies.
•In January, Gary Lee, Ph.D. was named Chief Scientific Officer. Dr. Lee is a veteran biotech leader with more than a decade of experience heading translational cell and gene therapy programs.
Fourth Quarter and Full Year 2022 Financial Results
Lyell reported a net loss of $8.4 million and $183.1 million for the fourth quarter and year ended December 31, 2022, respectively, compared to a net loss of $83.7 million and $250.2 million for the same periods in 2021. Non‑GAAP net loss, which excludes non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of success payment liabilities and certain non-cash investment gains and charges, was $0.3 million and $104.2 million for the fourth quarter and year ended December 31, 2022, respectively, compared to $41.7 million and $147.9 million for the same periods in 2021.
Revenue
•Revenue was $48.4 million and $84.7 million for the fourth quarter and year ended December 31, 2022, respectively, compared to $2.8 million and $10.7 million for the same periods in 2021. The increase in revenue was driven primarily by recognizing the remaining deferred revenue from the GSK collaboration agreement.

GAAP and Non-GAAP Operating Expenses
•Research and development (R&D) expenses were $38.0 million and $159.2 million for the fourth quarter and year ended December 31, 2022, respectively, compared to $19.3 million and $138.7 million for the same periods in 2021. The increase in fourth quarter 2022 R&D expenses was primarily driven by non-cash expenses related to the change in the estimated fair value of success payment liabilities. The increase in annual 2022 R&D expenses was due primarily to increases in personnel and infrastructure costs to support the expansion of our R&D and manufacturing capabilities. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities for the fourth quarter and year ended December 31, 2022, were $41.0 million and $147.6 million, respectively, compared to $32.2 million and $119.7 million for the same periods in 2021.
•General and administrative (G&A) expenses were $26.3 million and $117.3 million for the fourth quarter and year ended December 31, 2022, respectively, compared to $31.9 million and $89.1 million for the same periods in 2021. The decrease in fourth quarter 2022 and increase in annual 2022 G&A expenses were both primarily driven by changes in non-cash stock-based compensation. Non‑GAAP G&A expenses, which exclude non-cash stock-based compensation, for the fourth quarter and year ended December 31, 2022 were $12.3 million and $52.1 million, respectively, compared to $13.4 million and $42.2 million for the same periods in 2021. The increase in annual 2022 non-GAAP G&A expenses was driven by increased legal and corporate expenses and public company operating costs.
A discussion of non-GAAP financial measures, including reconciliations of the most comparable GAAP measures to non‑GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of December 31, 2022 were $710.3 million, compared to $898.3 million as of December 31, 2021. Lyell believes that its cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into 2026.

On February 28, 2023 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported that it will release its fourth quarter 2022 financial results on Thursday, March 2, 2023 after the markets close. Management will conduct a conference call and live webcast at 5:00 p.m. ET (4:00 p.m. CT) that day to discuss the financial results and to provide a business update (Press release, Lexicon Pharmaceuticals, FEB 28, 2023, View Source [SID1234627855]).

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Dial-in Information
U.S. Dial-in Number: (888) 317-6003
International Dial-in Number: (412) 317-6061
Conference ID: 8206864

Replay Information
U.S. Dial-in Number: (877) 344-7529
Replay International Dial-in Number: (412) 317-0088
Conference ID: 1407621

The dial-in replay will be available for 7 days following the call. An audio webcast will be available online at www.lexpharma.com/events, with a webcast replay accessible for 14 days after the call.

On February 28, 2023 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, reported that it will participate in two upcoming healthcare conferences (Press release, Alpine Immune Sciences, FEB 28, 2023, View Source [SID1234627853]).

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Tuesday, March 7th at 10:30am ET/7:30am PT, the Company will take part in a corporate panel discussion on autoimmune and inflammatory diseases and host investor meetings at the 46th Annual Cowen Healthcare Conference
Tuesday, March 14th at 3:20pm ET/12:20 pm PT, the Company will participate in a fireside chat and host investor meetings at the 33rd Annual Oppenheimer Healthcare Conference.
Live webcasts of the presentations will be available in the investor relations section of the Company’s website at View Source and replays will be available on the Company’s website for 90 days following the live events.

On February 28, 2023 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully-integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell therapies with a focus on immune-oncology, reported favorable safety results from the histopathology evaluation of a preclinical study of the pharmacology of KB-GDT-01 (trademark: Deltacel) administered alone and in combination with a non-biological anti-tumor therapy in mice (Press release, Kiromic, FEB 28, 2023, View Source [SID1234627851]).

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The histopathology report, authored by a certified veterinary pathologist, revealed no adverse microscopic findings related to the administration of Deltacel alone or as part of the combination treatment.

"We’re pleased to receive a clean pharmacology profile with no adverse findings and are encouraged by the preclinical results to-date in support of our planned IND submission. This histopathology report includes results from more than 500 histological sections from multiple organs of mice treated with Deltacel, with the combination treatment of Deltacel and a non-biological anti-tumor therapy, or mice left untreated. This study completes the necessary dataset for authoring the Pharmacology Report of the Efficacy Study, which is an essential component of the nonclinical module of our IND application," stated Leonardo Mirandola, Ph.D., Chief Scientific Officer of Kiromic BioPharma.

"These findings are in line with what we observed in a study evaluating Deltacel monotherapy at a dose more than 7 times higher than the maximum dose planned for the Deltacel clinical trial, and they confirm that Deltacel was well tolerated in mice, even when given as part of a combination therapy that further boosted its potency," continued Dr. Mirandola. "Kiromic plans to submit the Deltacel IND application to the U.S. FDA in this first quarter, and if accepted, plans to begin the activation of the clinical trial process in the second quarter of 2023. The planned clinical study will evaluate Deltacel in combination with a non-biological anti-tumor therapy for the treatment of non-small cell lung cancer."