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2021 Annual Report

On August 25, 2021 Pierre Fabre reported 2021 Annual Report (Presentation, Pierre Fabre, AUG 25, 2021, View Source [SID1234639493]).

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Precision BioSciences to Host In Vivo Gene Editing R&D Event on September 9, 2021

On August 25, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported that it will host its first R&D event focused on in vivo gene editing at 8:00 am ET on Thursday, September 9, 2021 (Press release, Precision Biosciences, AUG 25, 2021, View Source [SID1234591429]).

Precision’s gene editing event will feature presentations from Company management as well as featured guest speakers and will outline Precision’s development strategy to advance its in vivo gene editing portfolio. The agenda will include an overview of ARCUS, Precision’s proprietary platform for in vivo gene correction, new pre-clinical data, timelines for leading in vivo gene editing programs, and updates from academic and industry collaborators.

Company Conference Call and Webcast Information

Registration for the live webcast is available under Events & Presentations in the Investors section of the Precision BioSciences website at investor.precisionbiosciences.com. The dial-in conference call numbers for domestic and international callers are (866) 970-2058 and (873) 415-0216, respectively. The conference ID number for the call is 6376435. An archived replay of the webcast will be available on the Company website for one year following the presentation.

eFFECTOR Therapeutics Debuts as Publicly Traded Next-Generation Oncology Company Advancing Mature Pipeline with New Class of Cancer Therapies

On August 25, 2021 eFFECTOR Therapeutics, Inc. (eFFECTOR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, reported thatb completed its business combination with Locust Walk Acquisition Corp. (NASDAQ: LWAC) (Press release, eFFECTOR Therapeutics, AUG 25, 2021, View Source [SID1234587034]). The resulting combined company (the Company) has been renamed "eFFECTOR Therapeutics, Inc." and expects its common stock and public warrants will commence trading on Nasdaq under the new trading symbols "EFTR" and "EFTRW", respectively, starting on August 26, 2021.

The stockholders of LWAC approved the transaction at a special meeting held on August 24, 2021, and the transaction was previously approved by eFFECTOR’s stockholders. eFFECTOR’s management team, led by president and chief executive officer, Steve Worland, Ph.D., will continue to lead the Company.

"Cancer continues to be a major global health problem because of its complexity, including multiple escape mechanisms. That is why we are advancing the development of STRIs with the potential to target a central node that drives multiple disease processes simultaneously, including cancer’s inherent escape mechanisms," commented Dr. Worland. "We believe that our unique approach to development, along with the capital raised from this transaction, could help us unlock the potential of translation regulation to bring this new class of therapies through the clinic and ultimately to patients. Importantly, we anticipate that the cash available from the transaction will see our company through key Phase 2 data readouts for both of our lead programs."

"With a strong pipeline with multiple near-term data readouts, we are excited to see eFFECTOR Therapeutics take this very important next step in its evolution," stated Chris Ehrlich, former chief executive officer and director of LWAC who will continue as a director of the Company. "eFFECTOR’s expert team, along with the strategy to accelerate the development of innovative programs that are already progressing in the clinic, makes the Company well-positioned in its efforts to transform treatments for patients with cancer."

Advisors

Credit Suisse and Stifel acted as lead placement agents for the private placement (PIPE) in connection with the business combination, and Credit Suisse also acted as capital markets advisor to eFFECTOR. Locust Walk Securities also acted as PIPE placement agent. Latham & Watkins LLP acted as legal counsel to eFFECTOR. Cantor Fitzgerald acted as the lead capital markets advisor to LWAC. JMP Securities and Mizuho Securities also acted as capital markets advisors to LWAC. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as legal counsel to LWAC.

EDAP Reports Second Quarter 2021 Results and Provides Operational Update

On August 25, 2021 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported unaudited financial results for the second quarter of 2021 and provided an update on strategic and operational developments (Press release, EDAP TMS, AUG 25, 2021, View Source [SID1234586931]).

Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "We were very pleased during the second quarter to see continued strong growth in U.S. Focal One treatment volumes, a metric that we believe reflects accelerating HIFU adoption as a prostate cancer treatment alternative. While the ongoing COVID pandemic continues to weigh on hospital capital spending, we nonetheless continued to build a robust pipeline of Focal One and ExactVu pipeline opportunities, and we are optimistic that we will close additional high-profile sales this year."

"On the reimbursement front, just a few days ago, the CMS HOP panel voted unanimously in favor of increasing reimbursement for HIFU prostate ablation to APC Level 6 next year from Level 5 currently. Even if the HOP panel has only an advisory role to CMS, we believe this is a strong signal and further recognition of the value of HIFU in this indication. We hope this will be taken into account by CMS when building the final rule, which will be published in December of this year. If this is the case, reimbursement for Focal One HIFU would increase from an average of approximately $4,500 per procedure this year to an average of approximately $8,500 per procedure in 2022. This increase, if implemented, could be a significant catalyst to accelerating Focal One sales in 2022 and beyond."

"Importantly, our U.S. expansion plans, led by new U.S. subsidiary CEO Ryan Rhodes, are progressing and we are well financed with more than $53 million on our balance sheet. I believe we are poised for a strong back half of the year and accelerating HIFU momentum heading into 2022."

For the first six months 2021 Results

Total revenue for the first half of 2021 was EUR 20.7 million (USD 24.8 million), an increase of 22.5% compared to total revenue of EUR 16.9 million (USD 18.7 million) for the same period in 2020.

Total revenue in the HIFU business for the first six months of 2021 was EUR 3.8 million (USD 4.6 million), a decline of 15.1% as compared to EUR 4.5 million (USD 4.9 million) for the first six months of 2020.

Total revenue in the LITHO business for the first six months of 2021 was EUR 5.2 million (USD 6.2 million), a decline of 11.8% from EUR 5.9 million (USD 6.5 million) for the first six months of 2020.

Total revenue in the Distribution business for the first six months of 2021 was EUR 11.7 million (USD 14.0 million), a 79.0% increase compared to EUR 6.5 million (USD 7.2 million) for the first six months of 2020.

Gross profit for the first six months of 2021 was EUR 8.6 million (USD 10.3 million), compared to EUR 7.4 million (USD 8.2 million) for the year-ago period. Gross profit margin on net sales was 41.6% in the first six months of 2021, compared to 43.9% in the year-ago period. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 8.8 million (USD 10.5 million) for the first six months of 2021, compared to EUR 8.5 million (USD 9.5 million) for the same period in 2020.

Operating loss for the first six months of 2021 was EUR 0.2 million (USD 0.2 million), compared to an operating loss of EUR 1.2 million (USD 1.3 million) for the same period in 2020.

Net income for the first six months of 2021 was EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share, as compared to a net loss of EUR 1.5 million (USD 1.6 million), or EUR (0.05) per diluted share in the year-ago period.

As of June 30, 2021, the company held cash and cash equivalents of EUR 45.0 million (USD 53.3 million), as compared to EUR 24.7 million (USD 30.2 million) as of December 31, 2020.

Second Quarter 2021 Results

Total revenue for the second quarter 2021 was EUR 10.4 million (USD 12.4 million), an increase of 11.8% compared to total revenue of EUR 9.3 million (USD 10.3 million) for the same period in 2020.

Total revenue in the HIFU business for the second quarter 2021 was EUR 2.0 million (USD 2.4 million), a decline of 21.8% as compared to EUR 2.6 million (USD 2.8 million) for the second quarter of 2020.

Total revenue in the LITHO business for the second quarter 2021 was EUR 2.3 million (USD 2.7 million), a decline of 22.6% from EUR 2.9 million (USD 3.2million) for the second quarter of 2020.

Total revenue in the Distribution business for the second quarter 2021 was EUR 6.1 million (USD 7.3 million), a 61.6% increase compared to EUR 3.8 million (USD 4.2 million) for the second quarter of 2020.

Gross profit for the second quarter 2021 was EUR 4.2 million (USD 5.1 million), compared to EUR 4.3 million (USD 4.8 million) for the year-ago period. Gross profit margin on net sales was 40.7% in the second quarter of 2021, compared to 46.8% in the year-ago period.

Operating expenses were EUR 4.6 million (USD 5.6 million) for the second quarter of 2021, compared to EUR 4.0 million (USD 4.5 million) for the same period in 2020.

Operating loss for the second quarter of 2021 was EUR 0.4 million (USD 0.5 million), compared to an operating profit of EUR 0.3 million (USD 0.3 million) in the second quarter of 2020.

Net loss for the second quarter of 2021 was EUR 0.4 million (USD 0.5 million), or EUR (0.01) per diluted share, as compared to a net loss of EUR 0.2 million (USD 0.2 million), or EUR (0.01) per diluted share in the year-ago period.

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT tomorrow, August 26, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

INmune Bio, Inc. Announces Biomarker Data Demonstrating that the First Patient Treated with its NK Cell Priming “Pseudokine”, INKmune™, Successfully Produced Memory-Like NK Cells

On August 25, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the, "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that the first patient who received INKmune as a potential treatment for high-risk myelodysplastic syndrome (MDS) has successfully shown the NK activation and functional differentiation predicted by previously published in vitro experiments (Press release, INmune Bio, AUG 25, 2021, View Source [SID1234586926]).

NK cells need multiple activating signals to progress from a resting state to the triggering of cytolysis and cytokine secretion. INmune Bio has studied these pathways extensively and demonstrated that binding of NK cells with INKmune provides multiple activating signals and drives resting NK to the phenotype of memory-like NK (mlNK) cells with enhanced cancer-killing function. The company believes that this is the first ever successful generation of mlNK cells in patients.

"The INmune Bio team has been developing the concept of tumor cell-primed NK cells since 2004 with the creation of the first pharmaceutical-grade tumor line for NK priming a critical first step in testing whether these primed, memory-like NK cells could be generated in vivo." said Dr. Lowdell PhD, chief scientific officer of INmune Bio. "In the lab, INKmune binds to multiple NK ligands and initiates the activation of over 3,000 genes associated with function, trafficking, proliferation, and survival to form memory-like NK cells, which have superior cancer killing function. In our hands, no single cytokine has such broad physiological effects on NK cells compared to INKmune-primed NK cells, and this has inspired us to refer to INKmune as a pseudokine."

Preliminary data from the first patient shows that formation of mlNK cells can be achieved in vivo and without toxicity. INKmune was delivered in three doses on days one, eight and 15. INKmune therapy cause proliferation of NK cells with a doubling of the number of peripheral blood NK cell numbers on day 8. Over 50% of the expanded NK cells had an activated profile (CD69+/CD25+) on days eight and 15 and increased to over 70% by day 29. More than 80% of the activated NK cells expressed markers associated with a memory-like NK cell (CD57++, NKG2D+, NKG2A-ve, NKp46-ve). In vitro, the INKmune activated NK cells were better at killing cancer cells than the patient’s own NK cells prior to treatment, with an 82% increase in lysis of K562 leukemia cells and a 47% increase in lysis of NK-resistant RAJI lymphoma cell tumor cells as early as day eight. Despite this high level of activated NK cells and tumor killing, the patient showed no symptoms of Cytokine Release Syndrome (CRS).

"We are always cautious of single patient data but seeing these significant changes in peripheral blood NK cell populations in a patient treated at the lowest dose of INKmune is encouraging and identical to what we observed in pre-clinical studies," added Dr. Lowdell.

"Data from this patient demonstrates that INKmune can produce memory-like NK cells in patients," said RJ Tesi, M.D., chief executive officer of INmune Bio. "These biomarker data demonstrate that, even in a heavily pre-treated patient, INKmune can cause proliferation of the patients NK cells and convert them into the type of NK cells that are superior at killing cancer cells."

At least nine additional patients with high-risk MDS will be enrolled in the ongoing Phase I trial. A video overview of the INKmune platform can be found by clicking here.

About INKmune

INKmuneTM is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.