On August 25, 2021 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. ( hereinafter referred to as "ImmuneOnco") reported that 3 phase Ib/IIa trials of company’s lead drug candidate, IMM01, Fc fusion protein targeting CD47，the first in China, combined with Azacytitin for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), with Rituximab for relapsed/refractory B-cell lymphoma and with Inetetamab (CipterbinTM) in her2-positive solid tumors have been approved by the National Drug Products Administration (NMPA) (Press release, ImmuneOnco Biopharma, AUG 25, 2021, View Source [SID1234655626]). All clinical trials will be Initiated in the near future. The clinical trial of IMM01 combined with Inetetamab (CipterbinTM) will be cooperated with Sunshine Guojian (stock code , SHA: 688336) and mainly conducted by it. So far, total five clinical trial applications for IMM01 have been approved, which further establishes ImmuneOnco leading position in the research and development of CD47 target drugs.

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The ongoing Phase I study of IMM01 monotherapy for the treatment of patients with relapsed/refractory lymphoma (NHL & HL) has completed all scheduled doses of participants. No dose-limiting toxicity (DLT) is observed and no subjects developed anti-drug antibodies (ADA) except for minor infusion response in some patients. There were no drug-related serious adverse events (SAE). At the same time, some patients had an exciting indication efficacy response, especially for patients with recurrent/refractory classic Hodgkin’s lymphoma: 1 case of PR and 3 cases of SD in 5 patients with cHL, and the disease control rate reached 80%. Among them, the patient with PR was drug-resistant to PD-1 therapy. Currently, PR has lasted for 40 weeks and is still receiving treatment. In 1.5mg/kg dose group (the highest escalation dose group), four of the five patients enrolled had SD, two of them were SD with tumor shrinkage (17% and 33%, respectively). CR for 26 weeks was also observed in one patient.

"We are very pleased to see that the National Food and Drug Administration (NMPA) has approved clinical studies of IMM01 combined with Azacytitin, Rituximab and Inetetamab. The drug candidate IMM01, which is being tested in phase I clinical trials, has achieved long-lasting efficacy in some patients with advanced lymphoma at a low dose range with a good safety profile. Those clinical benefits are supported by the proprietary molecular design of IMM01. IMM01 does not bind to human red blood cells at all so as to avoid "Antigenic sink". Due to that in vivo infusion of the molecule doesn’t produce ADA and a smaller molecule (half molecular weight of regular IgG), it has higher tissue permeability and bioavailability. IMM01 has been tested in preclinical experiments in vitro in combination with various targeting and immunotherapeutic agents, efficacy appeared to be robust in tumor suppressive activity and potential to be applied to solid tumors. "We believe that IMM01 in combination with other drugs will provide significant advantages in clinical development." Dr. Tian Wenzhi, the founder of ImmuneOnco, is very confident of the IMM01 clinical trials. "We plan to expand IMM01 to apply in new indications and combination studies in the future to benefit more patients," he said.

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

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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]).

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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.

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.

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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.

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]).

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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.