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Instil Bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

On March 31, 2023 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its fourth quarter and full-year 2022 financial results and provided a corporate update (Press release, Instil Bio, MAR 31, 2023, View Source [SID1234629664]).

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Fourth Quarter 2022 Highlights and Anticipated Milestones:

Instil confirms cash runway beyond 2026 with consolidation of R&D operations to the UK: In January 2023, the Company announced the consolidation of the Phase 1 clinical trial and related manufacturing of CoStAR-TIL to its active operations in Manchester, UK leading to an extension of the expected cash runway to beyond 2026. Instil’s Manchester, U.K. operations have extensive experience and success in the manufacture and development of TIL and other cell therapy products since 2011. Instil continues to pursue a potential lease or sale of its commercial manufacturing facility in Tarzana, California. Under the current operating plan, starting in the second half of 2023, we expect quarterly cash burn of less than $10 million through the end of 2024.

ITIL-306 phase 1 study in UK anticipated to initiate in 2H’2023: Instil anticipates initiating a phase 1 study of ITIL-306 in the United Kingdom in the second half of 2023 following anticipated Clinical Trial Application, or CTA, clearance from the Medicines and Healthcare products Regulatory Agency, or MHRA. Instil anticipates initial clinical data from the ITIL-306 program in 2024.

Prioritization of ITIL-306 after discontinuation of ITIL-168 and subsequent consolidation to the UK for manufacturing: After a voluntary pause of the DELTA-1 trial for ITIL-168 in October 2022 due to a decreased rate of successful manufacturing of ITIL-168, the Company discontinued the program in December 2022 and announced a reduction in U.S. headcount and prioritization of CoStAR-TIL programs, including ITIL-306.
Fourth Quarter 2022 Financial and Operating Results:

As of December 31, 2022, Instil had $260.9 million in total cash and cash equivalents and marketable securities, comprised of $43.7 million in cash and cash equivalents and $217.2 million in marketable securities, compared to $454.1 million in total cash and cash equivalent and marketable securities, comprised of $37.6 million in cash and cash equivalents and $416.5 million in marketable securities, as of December 31, 2021. Instil expects that its cash, cash equivalents and marketable securities as of December 31, 2022 will enable it to fund its operating plan beyond 2026.

Research and development expenses were $20.7 million and $141.1 million for the fourth quarter and full year ended December 31, 2022, respectively, compared to $42.6 million and $107.3 million for the fourth quarter and full year ended December 31, 2021, respectively.

General and administrative expenses were $12.9 million and $62.2 million for the fourth quarter and full year ended December 31, 2022, respectively, compared to $11.2 million and $48.3 million for the fourth quarter and full year ended December 31, 2021, respectively.

Restructuring and impairment charges were $23.2 million for the fourth quarter and full year ended December 31, 2022.

INSTIL BIO, INC.
SELECTED FINANCIAL DATA
(Unaudited; in thousands, except share and per share amounts)

Statements of Operations

Three Months Ended
December 31, Year Ended December 31,
2022 2021 2022 2021
Operating expenses:
Research and development $ 20,722 $ 42,577 $ 141,056 $ 107,251
General and administrative 12,910 11,175 62,235 48,309
Restructuring and impairment charges 23,167 — 23,167 —
Total operating expenses 56,799 53,752 226,458 155,560
Loss from operations (56,799) (53,752) (226,458) (155,560)
Interest income 1,796 35 3,655 80
Interest expense (745) — (1,883) —
Other income (expense), net 1,299 (573) (564) (1,275)
Loss before income tax expense (54,449) (54,290) (225,250) (156,755)
Income tax benefit (expense) 605 (1,060) 2,073 (39)
Net loss $ (53,844) $ (55,350) $ (223,177) $ (156,794)
Net loss per share, basic and diluted $ (0.41) $ (0.43) $ (1.72) $ (1.48)
Weighted-average shares used in computing net loss per share, basic and diluted 129,872,810 128,952,362 129,512,610 105,993,230

Selected Balance Sheet Data

December 31,
2022 December 31,
2021
Cash, cash equivalents and marketable securities $ 260,920 $ 454,099
Total assets $ 482,128 $ 609,983
Total liabilities $ 118,523 $ 54,784
Convertible preferred stock and stockholders’ equity $ 363,605 $ 555,199

Note Regarding Use of Non-GAAP Financial Measures

In this press release, Instil Bio has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). These non-GAAP financial measures include non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding non-cash stock-based compensation expense. Instil Bio believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Instil Bio’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Instil Bio’s operating results. In addition, these non-GAAP financial measures are among the indicators Instil Bio’s management uses for planning purposes and to measure Instil Bio’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Instil Bio may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.

Three Months Ended
December 31, Year Ended December 31,
2022 2021 2022 2021
Net loss $ (53,844) $ (55,350) $ (223,177) $ (156,794)
Adjustments:
Non-cash stock-based compensation expense 6,643 8,904 30,441 26,197
Non-GAAP net loss $ (47,201) $ (46,446) $ (192,736) $ (130,597)
Non-GAAP net loss per share, basic and diluted $ (0.41) $ (0.43) $ (1.72) $ (1.48)
Adjustments
Non-cash stock-based compensation expense per share 0.05 0.07 0.24 0.25
Non-GAAP net loss per share, basic and diluted*. $ (0.36) $ (0.36) $ (1.48) $ (1.23)
Weighted-average shares used in computing net loss per share, basic and diluted 129,872,810 128,952,362 129,512,610 105,993,230
* Non-GAAP net loss per share, basic and diluted may not total due to rounding.

Inhibikase Therapeutics Reports Full Year 2022 Financial Results and Highlights Recent Period Activity

On March 31, 2023 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported financial results for the full year ended December 31, 2022 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAR 31, 2023, View Source [SID1234629663]).

"2022 was an important year for Inhibikase as we continued to advance and validate our lead asset IkT-148009 in the clinic and through data presentations at several notable scientific and industry conferences. While the FDA clinical hold on our IkT-148009 programs was an unexpected challenge, we were pleased to announce that the FDA lifted the hold on our Parkinson’s program in January 2023 and on Multiple System Atrophy, or MSA, in early March, 2023. As such, we are working diligently to restart the Phase 2a ‘201’ clinical trial and have begun planning for the Phase 2 program in MSA," said Dr. Milton H. Werner, President and Chief Executive Office of Inhibikase. "We will continue making progress across our pipeline in 2023. In addition to advancing IkT-148009 in the ‘201’ trial, we expect to complete our ‘501’ bioequivalence study for IkT-001Pro, our prodrug formulation of imatinib mesylate for Stable-Phase Chronic Myelogenous Leukemia. We look forward to providing updates throughout the year as we seek to bring our disease-modifying therapeutics to patients living with neurodegenerative diseases and cancer."

Recent Developments and Upcoming Milestones:

Full clinical hold on IkT-148009 in Parkinson’s disease programs lifted by the U.S. Food and Drug Administration (FDA): In January 2023, Inhibikase announced that the Phase 2a ‘201’ clinical trial for IkT-148009 would resume immediately at the 50 and 100 mg doses following the lift of the full clinical hold by the FDA. The Agency requested that the Company measure additional safety and pharmacokinetic data in healthy subjects at the 200mg dose ahead of implementation in the ‘201’ trial, measurements that are nearing completion. In addition, the Company will broaden its ocular monitoring program to measure visual acuity and examine the cornea and lens to complement the examination of the retina, macula and fundus that was already part of the ocular monitoring program in the trial. This monitoring program is consistent with the ocular pathology monitoring programs of other approved protein kinase inhibitors. The Company is re-opening clinical trial sites and initiating screening and enrollment of patients on a rolling basis.

Full clinical hold on IkT-148009 in MSA lifted by the U.S.FDA: In March 2023, Inhibikase announced that the Investigational New Drug (IND) application for the Phase 2 trial of IkT-148009 in MSA was lifted and the IND opened. This 6-month trial is currently in the planning stages, awaiting the outcome of prophylactic and therapeutic model studies evaluating the potential benefit of IkT-148009 as a treatment for MSA.

Highlighted publication demonstrating the potential of IkT-148009 as a disease-modifying therapy for Parkinson’s disease and related disorders: In January 2023, Inhibikase announced the publication of a paper entitled "The c-Abl inhibitor IkT-148009 suppresses neurodegeneration in mouse models of heritable and sporadic Parkinson’s disease," in the Journal of Science Translational Medicine (DOI: 10.1126/scitranslmed.abp9352). The published work illustrates the neurodegenerative functional screen that led to the discovery of IkT-148009 as well as data from once daily oral administration of IkT-148009 in several animal models that mimicked the rate of disease progression observed in human PD. Results from these studies demonstrated the ability of IkT-148009 to halt disease progression, drive functional recovery and protect neurons in the brain from degradation. Therapeutic benefit in these models was accompanied by substantial reduction of alpha-synuclein pathology in the brain. These data continue to demonstrate the potential of IkT-14809 as a disease modifying therapy and support the continued clinical development of IkT-148009 in Parkinson’s disease.

Dosed first three cohorts in the ‘501’ bioequivalence study of IkT-001Pro: In December 2022, Inhibikase announced the dosing of the first three patients in the ‘501’ bioequivalence study of IkT-001Pro, the Company’s prodrug formulation of imatinib mesylate intended to enhance the safety and efficacy of imatinib (marketed as Gleevec) in patients with Chronic Myelogenous Leukemia (CML). The ‘501’ study is a single ascending dose trial and will enroll approximately 59 male and female healthy volunteers between the ages of 25 to 55 who will receive IkT-001pro at one of four single doses. Three of the four dosing cohorts in the dose escalation phase have completed the study, with the fourth escalation cohort scheduled to dose in early April 2023. The primary objective of the study is to evaluate the safety profile of IkT-001pro as well as analyze and identify a dose that mimics systemic exposure and pharmacokinetics of 400mg imatinib mesylate, the standard-of-care dose for Stable-Phase CML. The study will also evaluate the adverse event profile and patient reported outcomes as metrics of superiority over standard-of-care. Upon completion of this study, the Company intends to initiate a discussion with the FDA to discuss the parameters of drug approval under the 505(b)(2) statute.

Successfully completed $10 million concurrent registered direct offering and private placement: In January 2023, Inhibikase raised $10 million in aggregate gross proceeds from its concurrent registered direct offering and private placement. The Company plans to use the net proceeds from the offerings for general corporate purposes, including clinical trials, product candidate development and manufacturing activities for product candidates and to meet working capital needs.
Full Year 2022 Financial Results

Grant Revenue: Grant revenue was $0.1 million for the year ended December 31, 2022 compared to $3.1 million in the prior year. The decrease was due to the Company’s primary focus during 2022 being shifted toward advancing our Phase I and II clinical trials which were not submitted for grant revenue.

R&D Expenses: Research and development expenses were $12.0 million for the year ended December 31, 2022 compared to $11.4 million in the year ended December 31, 2021. The increase was primarily due to ongoing non-grant related research and development activities mostly related to the Phase 2a ‘201’ clinical trial.

SG&A Expenses: Selling, general and administrative expenses for the year ended December 31, 2022 were $6.2 million compared to $6.5 million for the year ended December 31, 2021. The decrease was primarily the result of decreased warrant expense of $0.7 million and a decrease of stock-based compensation of $0.5 million partially offset by increased legal fees of $0.4 million, increased regulatory and compliance fees of $0.2 million and a net increase of $0.3 million for other normal operating expenses.

Net Loss: Net loss for the year ended December 31, 2022 was $18.1 million, or $0.72 per share, compared to a net loss of $14.8 million, or $0.81 per share in the year ended December 31, 2021.

Cash Position: Cash, cash equivalents and marketable securities were $23.1 million as of December 31, 2022. This excludes the net proceeds from the $10 million January 2023 concurrent registered direct offering and private placement. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2024.

Entry into a Material Definitive Agreement

On March 31, 2023, ImmunityBio, Inc. (the "Company") executed a $30.0 million convertible promissory note with Nant Capital, LLC ("Investor"), an entity affiliated with Dr. Patrick Soon-Shiong, our Executive Chairman and Global Chief Scientific and Medical Officer (Filing, 8-K, ImmunityBio, MAR 31, 2023, View Source [SID1234629662]). This note bears interest at Term Secured Overnight Financing Rate ("Term SOFR") plus 8.0% per annum. The accrued interest shall be payable quarterly on the last business day of March, June, September and December, commencing on June 30, 2023. The outstanding principal amount and any accrued and unpaid interest are due on the earlier of (i) December 31, 2023 or (ii) upon the occurrence and during the continuance of an Event of Default (as defined in the note). We may prepay the outstanding principal amount, together with any accrued interest, at any time, in whole or in part, without premium or penalty, upon five (5) days written notice to Investor. The note is convertible at Investor’s option following the date that is the trading day immediately prior to the opening of the Company’s next open trading window as determined by the Company’s board of directors in accordance with the Company’s Insider Trading Policy (the "Conversion Price Date"), in whole but not in part, into common stock of the Company, at a conversion price in accordance with the following formula: equal to the greater of (i) the Nasdaq Official Closing Price and (ii) the consolidated closing bid price of the Company’s common stock on the Conversion Price Date.

We received net proceeds of $29.85 million from this financing, net of a $150,000 origination fee (0.5%) paid to the Investor, which we intend to use, together with other available funds, to progress our pre-commercialization efforts and clinical development programs, fund other research and development activities, for capital expenditures, and for other general corporate purposes. We may also use a portion of the net proceeds to license intellectual property or to make acquisitions or investments.

The foregoing is only a brief description of the material terms of the note, and does not purport to be a complete description of the rights and obligations of the parties thereunder, and is qualified in its entirety by reference to the note that is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.

Nexcella, an Immix Biopharma Subsidiary, Announces 2023 Haematologica Editorial Highlighting NXC-201 Efficacy In The Context of U.S. Food And Drug Administration Approved BCMA CAR T Cells

On March 31, 2023 Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us") reported that an editorial written by Maria Sjöstrand and Michel Sadelain of Memorial Sloan Kettering Cancer Center was published 2023 in Haematologica highlighting NXC-201 in the context of the current U.S. Food And Drug Administration ("FDA") approved BCMA CAR-T Cell therapies (Press release, Immix Biopharma, MAR 31, 2023, View Source [SID1234629661]).

"The study [of NXC-201] shows a good safety profile, overall similar to other BCMA CAR T cell phase I-II studies, and similar efficacy, albeit with shorter follow-up, to that initially reported with the later FDA-approved BCMA CAR T cells (75% overall response rate [85% ORR in the group given the highest CAR T cell dose] compared with 85% in the phase I trial evaluating ide-cel [marketed as ABECMA by Bristol Myers Squibb] and 97% in the phase 1b/II trial for cilta-cel [marketed as CARVYKTI by Janssen/Johnson & Johnson])," the authors Maria Sjöstrand and Michel Sadelain stated. "[Furthermore, the NXC-201] trial included nine patients who had relapsed after treatment with an anti-BCMA antibody, belantamab mafodotin, prior to receiving HBI0101, which the authors suggested may be associated with a less favorable response to CAR therapy."

The title of the editorial is, "Driving CARs to new places: locally produced BCMA CAR T cells to treat multiple myeloma," published in Haematologica Early View, available at www.nexcella.com/publications.

To date, 58 patients have been treated with NXC-201, 50 in multiple myeloma, and 8 in AL amyloidosis.

The $13.9 billion Multiple Myeloma market in 2017 is expected to reach $28.7 billion in 2027 according to Wilcock, et al. Nature Reviews.

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 AL 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.

As of the October 23, 2022 data cutoff, updated clinical data in 47 patients from the ongoing Phase 1b/2a portion of the NEXICART-1 (NCT04720313) study of the novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 for the treatment of relapsed or refractory multiple myeloma and light chain amyloidosis (AL) showed:

Multiple Myeloma – 90% overall response rate (59% complete responses) for NXC-201 at the therapeutic dose in an ongoing 42-Patient Phase 1 expansion trial (Haematologica View Source, 5th European CAR-T cell meeting View Source) in relapsed/refractory multiple myeloma. All patients treated with NXC-201 were triple-class refractory (to at least 1 immunomodulatory drug, 1 proteasome inhibitor and 1 anti-CD38 antibody).
Additional data in 2023 demonstrated outpatient CAR-T treatment potential: cytokine release syndrome (CRS) median onset day zero; median CRS duration 1 day; no grade 4 CRS; only 1 grade 3 CRS across 42 relapsed/refractory multiple myeloma patients.
The expected primary endpoint for a pivotal study of NXC-201 in relapsed/refractory multiple myeloma is overall response rate.
AL Amyloidosis – 100% organ response rate (cardiac, renal, liver), 100% complete hematologic responses (MRD negativity 10-5), for NXC-201 in 8 relapsed/refractory AL Amyloidosis patients, of which the initial cohort was presented at the 5th European CAR-T cell meeting View Source, and published in Clinical Cancer Research View Source
The expected primary endpoint for a pivotal study of NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate.
The expected therapeutic dose of NXC-201 (800 million CAR+T cells) has already been established as the recommended Phase 2 dose (RP2D) for both multiple myeloma and AL amyloidosis.
Additional information on NXC-201 multiple myeloma clinical data as of October 23, 2022 is available here.

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 multiple myeloma and AL amyloidosis. The Phase 1b portion of the study has already established an expected recommended Phase 2 dose (RP2D) of 800 million CAR+T cells.

The expected primary endpoint for a pivotal study of NXC-201 will be overall response rate in multiple myeloma, and overall response rate in AL amyloidosis.

To date, 58 patients have been treated with NXC-201, 50 in multiple myeloma, and 8 in AL amyloidosis.

About Multiple Myeloma

Multiple myeloma ("MM") is an incurable blood cancer of plasma cells that starts in the bone marrow and is characterized by an excessive proliferation of these cells. Despite initial remission, unfortunately, most patients are likely to relapse. There are 34,470 patients in the United States diagnosed with MM each year. Prognosis for patients who do not respond to or relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents remains poor. The $13.9 billion Multiple Myeloma market in 2017 is expected to reach $28.7 billion in 2027 according to Wilcock, et al. Nature Reviews.

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. The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research.

iBio Advances Anti-CCR8 Antibody Program to Preclinical In Vivo Testing

On March 31, 2023 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported the progression of its anti-CCR8 antibody immuno-oncology program into preclinical in vivo testing (Press release, iBioPharma, MAR 31, 2023, View Source [SID1234629660]). CCR8, a member of the G protein-coupled receptor ("GPCR") family, is expressed by T-regulatory cells ("Tregs") that play a crucial role in inducing immunosuppression across various cancer types.

GPCRs are one of the most successful therapeutic target classes, with approximately one-third of all approved drugs targeting these proteins.1 Compared to small molecule-based GPCR drugs, antibody-based GPCR therapeutics potentially offer several potential advantages, including superior selectivity, extended mechanisms of action, and longer half-life. However, GPCRs are intricate, multi-membrane spanning receptors, making clinically relevant regions difficult to identify and target.

iBio employed its patented AI epitope steering platform in the discovery of anti-CCR8 molecules to overcome certain challenges associated with developing antibody-based GPCR-targeting therapeutics. iBio’s anti-CCR8 antibody is designed to selectively deplete Tregs, thereby allowing the immune system to effectively destroy cancer cells, without binding to CCR8’s closest neighbor, CCR4, significantly reducing the potential for adverse effects and safety issues associated with non-selective CCR8 antibodies.

Expressing his enthusiasm for the Company’s latest pipeline advancement, Martin Brenner, DVM, Ph.D., iBio’s Interim Chief Executive Officer and Chief Scientific Officer, commented, "Selective targeting of CCR8 shows our patented AI technology can successfully be applied to one of the most important drug target classes, and potentially allows us to pursue a range of other high-value GPCR targets in the future. We are pleased to be able to now move our anti-CCR8 molecules into in vivo testing."

Dillon Phan, PhD, iBio’s VP and Head of Early Research & Development, added, "We are thrilled to expand our Treg depletion franchise through our new anti-CCR8 program, which complements our existing IBIO-101 program. IBIO-101 is an anti-CD25 antibody designed to selectively bind and deplete Tregs in the tumor microenvironment without compromising immunostimulatory interleukin 2, or IL2, signaling to other T cells, thereby generating strong anti-tumor responses. We look forward to F. Hoffmann-La Roche’s anticipated presentation of clinical data for its IL2-sparing anti-CD25 antibody, RG6292, at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April, which we believe may validate IBIO-101 as a potential ‘fast-follower.’"