Iovance Biotherapeutics to Present at Upcoming Conferences

On April 24, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that senior leadership plans to present at the following conferences (Press release, Iovance Biotherapeutics, APR 24, 2023, View Source [SID1234630434]):

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Chardan’s 7th Annual Genetic Medicine and Cell Therapy Manufacturing Summit
Fireside Chat: April 24, 2023 at 1:00 p.m. ET
Virtual
H.C. Wainwright BioConnect
Fireside Chat: May 2, 2023 at 11:30 a.m. ET
New York, NY
The JMP Securities Life Sciences Conference
Presentation: May 16, 2023 at 3:00 p.m. ET
New York, NY
The live and archived webcasts will be available at View Source

INTEGRAGEN REPORTS 2022 ANNUAL RESULTS WITH A GROWTH OF 16% IN REVENUES AND A POSITIVE EBITDA

On April 24, 2023 IntegraGen, a company specializing in the decryption of the human genome, which carries out interpretable genomic analyzes for academic and private laboratories and develops diagnostic tools in oncology and part of OncoDNA Group, reported its annual audited results for the full year 2022 (Press release, Integragen, APR 24, 2023, View Source [SID1234630433]). The annual accounts were approved by the company’s Board of Directors which met on April 21st, 2023.

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Bernard Courtieu, CEO IntegraGen, said: « The 2022 results, the first full year post to the integration of IntegraGen in OncoDNA Group, reflect the robustness of our economic model, with a second year at break-even while continuing its developments.

In particular, the launch of the OncoDEEP Kit at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), held in Paris last September, which represents the first pan-cancer genomic panel resulting from the Group’s research, materializes new development prospects for the activities of IntegraGen in France.

In a context made difficult by the high inflation affecting reagents and energy, we were able to maintain our margins and generate a positive EBITDA for an overall turnover of €12,552k.

Thanks to the loyalty of our customers and partners, and the exceptional quality of the services rendered by all the employees, we are particularly proud to be able to present these results and more generally to continue our contribution to the projects of researchers and clinicians contributing to the improvement of patient care.»

Increase of genomic service activities performed by Evry lab

Genomic service activities, performed at our site in Evry, include services provided for research laboratories and teams in charge of clinical research.

The annual turnover recognized during the 2022 financial year increased by 8% to €5,129k. Laboratory activity was relatively low in the first half and intensified in the second half of the year.

In 2022, the genomics teams have carried out about 20.000 biological samples on the Evry platform.

Strong growth in services provided for the Institut Pasteur

IntegraGen continued its services for the shared microbiology (P2M) platform of the Institut Pasteur.

During the first quarter, the platform continued to be very active in the context of the Covid-19 virus pandemic and variant sequencing needs. Volumes related to Covid-19 began to decrease in the second half of 2022 to give way to the usual microbiology activity.

In 2022, the platform carried out nearly 84.428 microbial sequencings, including 53.078 for SARS-Covid-19 or a growth of 30%.

Increased sequencing for GCS SeqOIA

As a reminder, in 2018 the GCS SeqOIA (made up of Assistance Publique-Hôpitaux de Paris [AP-HP], the Institut Curie and the Gustave Roussy cancer center) accepted the offer of IntegraGen for the provision of an operating service for a high-throughput sequencing data production platform.

The platform’s operations have started in early 2019 and the patients’ sequencing services have progressively increased including the effect of the broadening of the indications. As a consequence, the turnover increased by 20% to €4 008k during the financial year 2022.

FINANCIAL RESULTS

Profit & Loss
In thousands of euros (€k) 2022 2021 Var. %
Revenues 13.167 11.324 16%
Other operating revenues 329 222 48%
Total revenues 13.496 11.546 17%
EBITDA 62 170 -63%
EBIT -139 -44 216%
Pre-tax current result -72 82 -188%
Net result -4 15 -123%
The 2022 revenues amounted to €13,167k, an increase of 16% compared to the previous year. Excluding recharge of personnel costs to the parent company, the turnover was €12,552k representing a growth of 17% compared to 2021 (€10,778k). This growth reflects increased activity in all sales segments.

Operating income was €13,496k compared to €11,546k in 2021 after taking into account transfers of charges and reversals of depreciation and provisions and subsidies.

Operating expenses amounted to €13,635k, up 18% compared to the year before. This increase is explained by various factors including the increase in the cost of consumables for sequencing production, the increase of sales and marketing costs and the increase in payroll charges. Over the period, the average workforce increased to 53 people versus 49.

Following the increase of revenues and the control on the costs despite the inflation, EBITDA was positive at €62k compared to €170k in 2021.

After the consideration of financial result, exceptional items and tax, the 2022 financial year ended with a net result of -€4k€ compared to a profit of €15k in the previous year.

Balance sheet
In thousands of euros (€k) 31/12/2022 31/12/2021
Fixed assets 468 624
Stock 387 342
Accounts receivables 3.220 3.357
Other receivables 441 492
Cash 4.507 4.781
Current assets 8.555 8.972
Translation difference 0 8
TOTAL ASSETS 9.023 9.604
In thousands of euros (€k) 31/12/2022 31/12/2021
Shareholder’s equity 2.182 2.186
Provisions for risks and charges 0 8
Financial debt 1.672 1.953
Advances received from customers 0 430
Accounts payables 3.216 3.552
Other payables 1.934 1.475
Translation difference 18 0
TOTAL LIABILITIES 9.023 9.604
As of December 31st, 2022, the company’s cash position was €4,507, a decrease of €274 compared to the end of 2021. This moderate variation remains in line with previous periods. The position includes a state guaranteed loan (Prêt Garanti par l’État, PGE) for an outstanding amount of €1 633k that the company started to reimburse last June.

OUTLOOK FOR 2023: CONTINUED GROWTH EXPECTED

IntegraGen expects continued revenue growth in 2023 based on the order book to be delivered and the positive trend observed in the market with academic and private clients.

The completed integration within the OncoDNA Group confirms IntegraGen’s commercial development prospects outside France.

The available cash will finance operational and investment needs.

In 2023, the company is continuing its investments in the areas of certification and quality assurance so as to be able to significantly increase its service offering to industry, particularly support activities for the clinical development of new molecules in oncology.

INmune Bio, Inc. to Report First Quarter 2023 Financial Results and Provide a Corporate Update on Wednesday, May 3

On April 24, 2023 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported that it will host a conference call on Wednesday, May 3, 2023 at 4:30 PM Eastern Time to discuss results for its first quarter ended March 31, 2023 and to provide a corporate update (Press release, INmune Bio, APR 24, 2023, View Source [SID1234630430]).

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Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio First Quarter Conference Call when reaching an operator.

Date: May 3, 2023
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-844-826-3035
Participant Dial-in (international): 1-412-317-5195
Conference ID: 10177985

A live audio webcast of the call can be accessed using this link or by clicking here:

View Source

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through May 10 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 10177985.

IN8bio Presents Positive, New INB-100 Data Showing Long-term Complete Remissions and Elevated Gamma-Delta T Cells in 100% of Evaluable Treated Leukemia Patients at EBMT 2023

On April 24, 2023 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported new positive data from the Phase 1 investigator-sponsored trial of INB-100 in leukemia patients (Press release, In8bio, APR 24, 2023, View Source [SID1234630429]). The data presented at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) showed that 100% of evaluable patients (n=7) treated with INB-100 remained alive, progression-free, and in durable complete remission (CR) as of April 21, 2023, indicating the curative potential of INB-100 for high-risk or relapsed AML and other hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT).

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"We are thrilled to report that 100% of evaluable dosed patients remain in morphological CR with the first three high-risk AML patients with complex cytogenetics now alive and relapse-free, with one patient surviving for as long as 3 years," said Dr. Trishna Goswami, IN8bio’s Chief Medical Officer. Further, "INB-100 has demonstrated, for the first time, in vivo expansion and persistence of an allogeneic, or donor-derived cellular therapy at the higher levels associated with greater survival outcomes."

The latest data on immune reconstitution presented at EBMT showed significant allogeneic gamma-delta T cell expansion and persistence in patients through the first 180 days post-treatment. Patients who received INB-100 treatment at Dose Level 2 exhibited an average of 82.9x greater gamma-delta T cell expansion at 60 days compared to patients undergoing haploidentical HSCT without INB-100 therapy. The gamma-delta T cell levels in Dose Level 2 patients are also, on average, 12.8x greater than those achieved in Dose Level 1, demonstrating a dose-response related to the gamma-delta T cell infusion. Elevations in CD4+, CD8+ T cells, NK cells and B cells have also been observed, indicating a broad positive immune response.

The study’s updated safety data reported low-grade (1-2) graft versus host disease (GvHD) in all patients treated, which was steroid-responsive, and had a more rapid onset at higher dose levels. No dose limiting toxicities (DLTs) have been observed. As of April 21, 2023, all evaluable patients across Dose Levels 1 and 2 remained on study and in CR, with one patient remaining progression free for over 3 years. Additional treated patients have remained progression free for 33.9, 22.2, 7.8, 5.8, 5.6 and 2.6 months, respectively.

"The data that continue to emerge from this clinical trial are very encouraging and suggest that INB-100 may offer a new treatment option for this high-risk population," said Dr. Joseph McGuirk, the Schutte-Speas Professor of Hematology-Oncology, Division Director of Hematological Malignancies and Cellular Therapeutics and Medical Director, Blood and Marrow Transplant at The University of Kansas Cancer Center and the Principal Investigator on the study. "While the data are early, it is encouraging that all evaluable treated patients have shown positive clinical outcomes and durable responses, particularly in light of the high-risk and complex cytogenetics of these patients."

The positive outcome of ongoing durable patient CRs, combined with the benefit/risk profile, led to the decision to select Dose Level 2 as the RP2D. The trial is being expanded at this dose level, and additional patients are actively being enrolled and treated in the study, with updated data expected to be presented at a medical meeting later this year.

Conference Call Details

IN8bio will host a conference call and webcast today, April 24, 2023, at 10:00 a.m. ET to review the updated data from the EBMT presentation, as well as recent clinical updates. The webcast can be accessed by clicking the link: View Source and can also be accessed on the Events & Presentations page of the Company’s website.

About the INB-100 Phase 1 Trial

The Phase 1 clinical trial (NCT03533816) is an investigator-sponsored dose-escalation trial of allogeneic derived, gamma-delta T cells from matched related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following HSCT. The single-institution clinical trial is currently being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.

AI Powered Precision Antibody Therapeutics

On April 24, 2023 IBio Pharma presented its corporate presentation (Presentation, iBioPharma, APR 24, 2023, View Source [SID1234630427]).

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