On January 6, 2023 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported its participation in the 41st Annual JP Morgan Healthcare Conference, taking place January 9-12, 2023 (Press release, Lexicon Pharmaceuticals, JAN 6, 2023, View Source [SID1234625971]).

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Lonnel Coats, Lexicon’s chief executive officer, will make a company presentation which will be available on-demand beginning at 3:00 pm ET/12:00 pm PST on Thursday, January 12, 2023.

A simultaneous webcast of the presentation will be available in the "Events" section of the Lexicon website at www.lexpharma.com/events, and a recording of the webcast will be available for two weeks following the original on-demand date.

On January 6, 2023 Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us") reported that NXC-201 treatment continues to demonstrate 100% complete responses in a total of 6 relapsed/refractory AL amyloidosis patients (Press release, Immix Biopharma, JAN 6, 2023, View Source [SID1234625967]). Clinical data published December 2022 in Clinical Cancer Research (View Source) demonstrated 100% complete response rate; 100% organ response rate; NXC-201 Duration of Response Not Yet Reached at a median follow-up of 5.2 months (range: 2.5-9.5 months), resulting in a mean 65% reduction (2,656pg/mL) in NT-proBNP from baseline; no grade 4 Cytokine Release Syndrome (CRS); no ICANS neurotoxicity was observed; a 2-stage improvement in NYHA stage was observed. Low-grade CRS duration of median 2 days (range:1-4 days) with median onset on day 2 (range: 1-3 days) points to NXC-201 potentially becoming the first and only out-patient CAR-T to treat AL Amyloidosis and other BCMA-positive malignancies.

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"As we enroll additional patients, we continue to be encouraged by the consistent 100% complete response rate for AL amyloidosis patients treated with NXC-201 to-date," said Gabriel Morris, President, Nexcella, Inc. "We are heartened to provide hope for patients with this devastating disease in our ongoing efforts to bring NXC-201 to market."

Immix Biopharma Subsidiary Nexcella, Inc Announces Additional Positive NXC-201 Clinical Data Demonstrating 100% Complete Responses in Relapsed/Refractory AL Amyloidosis Patients, Duration of Response Not Yet Reached

4 patients with relapsed or refractory AL amyloidosis treated with NXC-201 were included in the December 2022 Clinical Cancer Research publication. 4 of 4 patients (100%) experienced a complete response and 4 of 4 patients (100%) experienced an organ response after treatment with NXC-201. 4 of 4 patients (100%) had cardiac involvement at the time of their baseline echocardiogram reading as defined by NT-proBNP levels (>100 pg/ml) (range: 119 – 7,500. Mean 3,100. Median 2,391). Treatment with NXC-201 resulted in a mean 65% (mean 2,656 pg/mL) reduction in mean NT-proBNP from baseline. Additionally, a 2-stage improvement in NYHA stage was observed after treatment with NXC-201.

About NEXICART-1

NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed or refractory plasma cell dyscrasias, including multiple myeloma and AL amyloidosis.

The primary objective of the Phase 1b portion of the study, is to characterize the safety and confirm the Maximally Tolerated Dose (MTD) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 with endpoints of overall survival, progression-free survival and response rates.

About NXC-201

NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and amyloidosis. The design consists of a structurally differentiated CAR-T, with our proprietary BCMA-targeting CAR, which has demonstrated reduced toxicity in NEXICART-1, supporting investigating NXC-201 as an outpatient therapy.

About AL Amyloidosis

AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by plasma cells cause buildup in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage, and high mortality rates.

AL amyloidosis affects roughly 30,000 – 40,000 patients in total throughout the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases of AL amyloidosis annually in the U.S. The annual global incidence of AL Amyloidosis is ~15,000 patients.

On January 6, 2023, Keros Therapeutics, Inc. (the "Company") entered into a first amendment (the "Lease Amendment") to that certain indenture of lease, dated September 7, 2021 (as amended, the "Lease") with Revolution Labs Owner, LLC, a Delaware limited liability company (the "Landlord"), with respect to the Company’s office and laboratory space consisting of approximately 35,662 square feet located at 1050 Waltham Street, Lexington, Massachusetts (the "Premises") (Filing, 8-K, Keros Therapeutics, JAN 6, 2023, View Source [SID1234625970]).

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Under the terms of the Lease Amendment, the Company has agreed to the phased delivery of the Premises to the Company by the Landlord as follows: (i) the Landlord will deliver approximately 31,991 square feet of the Premises (the "Phase A Premises") on or before January 4, 2023 (the "Phase A Premises Commencement Date"), and (ii) the Landlord will deliver the additional approximately 3,671 rentable square feet of vivarium space (the "Phase B Premises") when the Landlord substantially completes work on the Phase B Premises, currently estimated to occur on or before May 1, 2023 (the "Phase B Premises Commencement Date").

Per the Lease Amendment, the term of the Lease will now commence on the Phase A Premises Commencement Date. The Lease has a term of eight years, measured from the Phase A Premises Commencement Date.

The Company’s obligation for the payment of base rent for the Phase A Premises begins on the date which is earlier to occur of (i) eight months following the Phase B Premises Commencement Date or (ii) 11 months following the Phase A Premises Commencement Date (such earlier date, the "Phase A Rent Commencement Date"). The Company’s obligation for the payment of base rent for the Phase B Premises begins on the date which is eight months following the Phase B Premises Commencement Date (the "Phase B Rent Commencement Date"). Base rent will initially be fixed at $202,084.66 per month, which will increase by approximately 3% per annum. From and after the Phase A Rent Commencement Date and until the occurrence of the Phase B Rent Commencement Date, the Company will be obligated to pay base rent at the per square foot rent for the Phase A Premises only. Upon the Phase B Rent Commencement Date, the Company will be obligated to pay the base rent for the entirety of the Premises. The Company will be obligated to pay the Landlord for certain costs, taxes and operating expenses as specified in the Lease.

The description of the Lease Amendment contained in this Current Report on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the Lease Amendment, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending March 31, 2023.

On January 6, 2023 Immunome presented its corporate presentation (Press release, Immunome, JAN 6, 2023, View Source [SID1234625968]).

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On January 6, 2023 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling and advanced medicinal chemistry technology, reported certain preliminary, unaudited financial results for the year ended December 31, 2022 (Press release, HTG Molecular Diagnostics, JAN 6, 2023, View Source [SID1234625966]).

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Total revenue for the full year 2022 is expected to be approximately $6.4 million, including approximately $2.7 million of HTG Transcriptome Panel (HTP) revenue representing 42% of our total revenue. Cash and cash equivalents are approximately $12.2 million as of December 31, 2022.

"While our full year revenue did not show the level of recovery anticipated in 2022, we believe that our Q4 and full year results reflect positive trends," said John Lubniewski, CEO of HTG. "First, we are encouraged to see revenue grow by nearly 95% from the third quarter to the fourth quarter of 2022. This revenue includes both orders from customers who have previously adopted our technology and are regularly reordering kits and services, as well as orders from new customers. The year-over-year revenue also reflects an increase from 2021 to 2022 of $1.3 million of HTP revenue, demonstrating growing demand for this potentially transformational product. Second, our preliminary cash and equivalents position shows a strengthened balance sheet. Considering recent revenue performance in our profiling business, we are focused on right-sizing this business, increasing efficiencies and minimizing spend without jeopardizing our ability to generate higher levels of profiling revenue or impacting our drug discovery milestones. As we look toward the rest of 2023, we are hopeful a leaner profiling business will continue to provide value to our customers, driving quality revenue and further adoption of our technology while supporting our therapeutics initiative."

The preliminary results set forth above are unaudited, are based on management’s initial review of the company’s results as of and for the year ended December 31, 2022 and are subject to revision based upon the company’s year-end closing procedures and the completion and external audit of the company’s year-end financial statements. Actual results may differ materially from these preliminary unaudited results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that company’s financial results are finalized, and such changes could be material. In addition, these preliminary unaudited results are not a comprehensive statement of the company’s financial results for the year ended December 31, 2022, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the company’s results for any future period.

The company expects to announce full 2022 financial results in advance of its quarterly conference call in March 2023.