On August 25, 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable FastPharming Manufacturing System, reported that it has signed a definitive worldwide exclusive license agreement with RubrYc Therapeutics, Inc., ("RubrYc") for RTX-003, an immunotherapy candidate targeting regulatory T cells (Tregs) (Press release, iBioPharma, AUG 25, 2021, View Source [SID1234586880]). The partnership also includes an option agreement for iBio to license additional antibodies built using RubrYc’s artificial intelligence ("AI")-based antibody discovery platform.

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"We are pleased to add another promising candidate to our growing oncology R&D pipeline, and especially one with such a compelling mechanism of action," said Tom Isett, Chairman & CEO of iBio. "Designing an antibody that effectively binds CD25 without blocking the IL-2 signaling pathway is a widely recognized challenge, so the successful preclinical development of RTX-003 provides validation of RubrYc’s capabilities. Moving forward, we aim to replicate this discovery and development model by combining access to the RubrYc Discovery Platform with iBio’s proprietary Glycaneering and FastPharming Technologies to bring multiple new candidates to the clinic in a timely and cost-efficient manner."

CD25 has emerged as a promising target in immuno-oncology because it is expressed by immunosuppressive Tregs and overexpressed in certain tumor cells. Preclinical data on RTX-003 has shown that it selectively binds and depletes Tregs in the tumor microenvironment without compromising immunostimulatory interleukin 2 ("IL2") signaling to other T cells, thereby generating strong anti-tumor responses. These robust anti-tumor effects were observed using RTX-003 as a monotherapy, as well as in combination with checkpoint inhibitors.

The positive RTX-003 preclinical data are consistent with results from another non-IL2 blocking anti-CD25 antibody, one that is now in a Phase I clinical trial. Given the validation for this mechanism of action, iBio plans to use its development and manufacturing capabilities to advance RTX-003 to the clinic as IBIO-101, which is a version of RTX-003 produced in plants using the FastPharming System. Initiation of IND-enabling studies is expected by mid-2022.

As part of the agreements, iBio made an upfront $5.0 million payment to RubrYc, with an additional $2.5 million commitment for December 2021. In return, the Company will receive the RTX-003 commercialization rights, options for additional molecules developed using RubrYc’s predictive algorithms, and an equity stake. RubrYc is eligible to receive certain pre-specified payments upon achievement of development milestones for IBIO-101, as well as royalties on net sales of that molecule and other licensed antibodies.

Isaac J. Bright, M.D., CEO of RubrYc, commented: "This partnership creates tremendous synergy with three platform technologies that together may accelerate the rapid discovery and development of next-generation immunotherapies. We look forward to our exciting new collaboration with iBio."

On August 25, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in three upcoming virtual investor conferences (Press release, BioMarin, AUG 25, 2021, View Source [SID1234586896]). An audio webcast of the presentations will be available live. You can access the webcasts at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

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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.

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 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported the initiation of Dose Escalation within the Phase I Investigator Initiated Trial (IIT) of Pidnarulex for the treatment of advanced hematological malignancies (Press release, Senhwa Biosciences, AUG 25, 2021, View Source [SID1234586897]). After evidence of human efficacy was observed in patients with specific biomarkers and resistant to standard treatments, including chemotherapeutics, the Phase I study was redesigned to further determine the Recommended Phase II Dose.

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This open-label dose escalation Phase I IIT study of Pidnarulex is sponsored by the Peter MacCallum Cancer Center (PMCC), in Australia, focusing on various haem cancers, including multiple myeloma, T-cell non-Hodgkin lymphoma, acute myeloid leukaemia and myelodysplastic syndrome. Senhwa is providing the study supplies and the Investigational Product, Pidnarulex, which is intravenously administered on 4-week cycles.

The preliminary results from the preceding portion of the Phase I study, completed in 2017, demonstrated that among the 16 evaluable patients, one patient experienced a partial response after the Pidnarulex treatment, while five patients had stable disease. The PMCC was invited to the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting on 11th December, 2017, and presented a poster on these findings.

"The multiple myeloma patients enrolled in the initial portion of the Phase I study were resistant to other therapies; however, fifty percent of the multiple myeloma patients treated with Pidnarulex were able to stabilize their conditions. We here at Senhwa will continue to work at providing alternative therapeutics for treatment resistant cancers," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

"We look forward to the outcome of this study and we hope that the findings may inspire more collaborative opportunities to determine if Pidnarulex is effective in treating various forms of haem cancers," said Tai-Sen Soong, the Chief Executive Officer of Senhwa Biosciences.

Hematological cancers affect populations worldwide, notably, there are more than 160,000 new cases of multiple myeloma worldwide per year. The global drug market for multiple myeloma is expected to reach USD 37.5 billion by 2024, according to the forecast of Grand View Research, a leading market research firm.

About Pidanrulex (CX-5461)

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by Pidnarulex through a synthetic lethality approach by targeting the DNA repair defects in Homologous Recombination Deficiency (HRD) tumors. Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death. On the other hand, PMCC postulates a different mechanism of action. Specifically, it is thought that Pidanrulex acts as a RNA Pol I Inhibitor.