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OPKO Health to Report Second Quarter 2021 Financial Results on July 29, 2021

On July 20, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported operating and financial results for the three months ended June 30, 2021, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, July 29, 2021. OPKO’s senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on July 29th beginning at 4:30 p.m. Eastern time.

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CONFERENCE CALL & WEBCAST INFORMATION

OPKO encourages participants to pre-register for the conference call using the link here. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call. Alternatively, please dial (888) 869-1189 or (706) 643-5902 and use conference ID 7028169

To access the live call via webcast, please click on the link OPKO 2Q21 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 2Q21 Results Conference Call. A telephone replay will be available beginning approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 7028169.

Nanobiotix Provides Second Quarter Operational and Financial Update

On July 20, 2021 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’) (Paris:NANO) (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported operational progress and cash position (unaudited) for the second quarter of 2021 (Press release, Nanobiotix, JUL 20, 2021, View Source [SID1234584977]).

Second Quarter Financial Updates

Nanobiotix reported total revenue for the six-month period ended June 30, 2021 of €9.7k. Revenue for the first half of 2021 was primarily driven by cross charges related to the Company’s previous collaboration with PharmaEngine, Inc., during the first quarter 2021. Nanobiotix did not generate any revenue during the second quarter of 2021. Revenue for the second quarter and first half of 2020 amounted to €13.4k and €36.9k respectively.

Nanobiotix reported cash, cash equivalents, and short-term investments totaling €102.3 million as of June 30, 2021, compared to €107.1 million as of March 31, 2021. This amount includes the €16.5 million ($20.0 million) upfront payment associated with the LianBio collaboration announced in May 2021. As previously announced, PharmaEngine was eligible for and received a €2.1 million ($2.5 million) payment following the announcement of Nanobiotix’s collaboration with LianBio and has received €3.4 million ($4.0 million) in conjunction with the completion of various administrative steps in connection with the winding-up of the collaboration. PharmaEngine will be eligible to receive an additional $1.0 million in administrative fees and a final payment of $5 million upon a second regulatory approval of an NBTXR3-containing product.

Nanobiotix plans to report half-year financial results for the six-months ended June 30, 2021, including condensed consolidated financial statements for the period, on September 8, 2021.

Second Quarter Operational Highlights

Presented Updated Results from Priority Pathways in Head and Neck Cancer and Immunotherapy for Potential First-In-Class Radioenhancer NBTXR3 at 2021 Annual Meeting of The American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper):
Local Control as a Single-Agent for Patients with Head and Neck Cancer: Updated data from Study 102, a phase I study evaluating NBTXR3 as a single agent activated by radiotherapy in locally advanced head and neck squamous cell carcinoma (LA- HNSCC) presented at ASCO (Free ASCO Whitepaper) further support NBTXR3 administration as feasible, and well-tolerated with a favorable safety profile in highly vulnerable elderly LA-HNSCC patients with high unmet medical needs and significant burden of disease. At a median follow up of 8.1 months, evaluable patients (n=40) demonstrated a high primary tumor ORR of 82.5% and a 62.5% CRR. These results are consistent with those observed in the dose escalation part of the study and suggest durability of efficacy. Nanobiotix plans to launch a pivotal phase III global registration study evaluating NBTXR3 as a single-agent activated by radiotherapy for patients with LA-HNSCC in the second half of 2021.
Priming Immune Response and Immunotherapy Combination Across Oncology:Updated data from Study 1100, a phase I basket study evaluating NBTXR3 activated by radiotherapy (RT) in combination with nivolumab or pembrolizumab in locoregional recurrent or recurrent metastatic HNSCC, lung metastasis from any primary tumor and/or liver metastasis from any primary tumor showed tumor regression in 76.9% of evaluable patients (n=13) regardless of prior anti-PD-1 exposure. Data from this ongoing study show NBTXR3 plus radiotherapy could potentially stimulate immune response and convert anti-PD-1 non-responders into responders.
Formed Strategic Partnership with LianBio to Develop and Commercialize NBTXR3 Across Tumor Types and Therapeutic Combinations in China and other Asian markets:
LianBio’s cross-border development and commercialization expertise includes strong capabilities in oncology: LianBio will participate in the Nanobiotix global phase III HNSCC registrational study by enrolling 100 patients in China. In addition to the phase III head and neck cancer study, LianBio has committed to enrolling patients in four additional registrational studies conducted by Nanobiotix across indications and therapeutic combinations. Under the terms of the agreement, LianBio will obtain exclusive rights to develop and commercialize NBTXR3 in Greater China, South Korea, Singapore, and Thailand. Nanobiotix received a $20 million upfront payment and is entitled to receive up to an aggregate of $220 million in potential contingent, development and commercialization milestone payments along with tiered, low double-digit royalties based on net sales of NBTXR3 in the licensed territories.
Strengthened Board & Leadership Team to Focus Efforts on Advancing Its Global Development Strategy:
Named Gary Phillips, MD, as the new chairman of the Company’s supervisory board: Dr. Phillips, who is the president and chief executive officer of OrphoMed, Inc., brings decades of experience in the pharmaceutical and healthcare industries where he has led commercial operations, clinical medicine, business strategy, and development functions.
Appointed Bart Van Rhijn, MBA, as chief financial officer and member of the Company’s executive board: Mr. Van Rhijn brings extensive experience in consultancy, technology, and life sciences industries and joins Nanobiotix after nearly 3 years as chief financial officer at Servier Pharmaceuticals, LLC (Servier US). Prior to Servier US, he held leadership roles in prominent organizations in Europe and North America, including PricewaterhouseCoopers, Philips and Galderma, including Head of Tax, Senior Director of Mergers and Acquisitions, and Head of Finance positions.
Updated Financial Agenda

September 8: Half-Year Corporate and Financial Update
October 20th: Third Quarter Corporate and Financial Update

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a phase III global registrational study is planned to launch in 2021. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the planned phase III study.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company-sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) for MD Anderson to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

Micronoma, University of New South Wales Tackle Liver Cancer with $4 Million Grant

On July 20, 2021 Micronoma, the first cancer detection company to harness tumor-associated circulating microbial biomarkers to diagnose cancer at an early stage via microbiome-driven liquid biopsy technology, reported a collaboration with the University of New South Wales (UNSW), Sydney for a $4 million grant from the Australian Government to fund research into hepatocellular carcinoma (HCC), the most common type of primary liver cancer (Press release, Micronoma, JUL 20, 2021, View Source [SID1234584976]).

The collaboration, led by Associate Professor Amany Zekry and Professor Emad El-Omar from UNSW Medicine & Health will enable the development of microbial-based biomarkers powered by artificial intelligence for early detection of liver cancer. Micronoma’s Chief Scientific Officer, Eddie Adams, joins these world-class, multi-disciplinary experts at UNSW in the fields of liver disease, liver cancer, microbiome, metabolomics, and artificial intelligence as a co-principal investigator on the grant.

This research will use machine learning to examine thousands of microbiome plasma features to discover, validate, and translate microbial-derived biomarkers for the early detection of HCC, thus improving the chances of survival of HCC patients and making effective risk disease stratification possible.

"This collaboration with UNSW combines a rare and exciting set of expertise in liver cancer and gut microbiome with our proprietary method of analyzing circulating microbiome signatures. Importantly, being awarded this grant by the Australian Government serves as a strong external validation of our technique and will serve to showcase Micronoma’s unique approach to diagnostics," Micronoma CEO Sandrine Miller-Montgomery said. "There has been growing interest in the compelling link between circulating microbiome signatures and early detection since our publication in Nature. Developing a method to enable the identification of robust microbial plasma biomarker signatures of HCC is in our product pipeline and this collaboration enables us to fast-track product development."

"Our ongoing collaboration with Micronoma strengthens the innovative potential of this research. Micronoma is currently the only cancer diagnostic company in the world that uses microbial DNA signatures in the blood (mb-DNA) to detect early-stage cancer," said Professor Zekry. "Their minimally invasive microbiome-driven liquid biopsy approach is focused on detecting early-stage lung cancer and will provide valuable expertise in establishing an HCC-related microbiome platform."

The diagnostic implications of microbiome markers in liquid and tissue biopsies are extensive, and Micronoma is prepared to lead the way on helping prevent unnecessary suffering caused by later-stage cancer diagnosis, as well as potentially enabling personalized and less invasive treatments at the earliest stages of cancer.

MaaT Pharma Awarded France Relance Government Grant to Accelerate Development in Immuno-Oncology and Support Manufacturing of Next Generation Microbiome Therapies

On June 20, 2021 MaaT Pharma, a French clinical-stage biotech company specialized in the development of microbiome-based therapies aiming to restore the microbiome/immune system symbiosis in oncology patients, reported that its MEPA (Microbiome Engineering Platform) program was awarded a EURO 1.9 million grant from the Plan France Relance (Press release, MaaT Pharma, JUL 20, 2021, View Source [SID1234584975]). Initiated during the Summer of 2020, Plan France Relance was established to make strategic investments in critical sectors of French industry, including Health.

"We are very honored and proud to be laureates of the France Relance initiative. The French Government’s commitment to invest in strategic industries is an opportunity for MaaT Pharma, as a key player in the microbiome industry, to further pursue our development plans and to actively contribute to the biomanufacturing of innovative drugs in France. This is a team success, and this financing supports the efforts of women and men at MaaT Pharma who work tirelessly to deliver groundbreaking innovations in microbiome therapeutics," said Hervé Affagard, Founder and CEO at MaaT Pharma. "The France Relance program will support the development of our unique and innovative industrial processes that leverage all the functional diversity of the microbiome to deliver better outcomes in cancer treatment."

MEPA, supporting a new generation of microbiome therapies

MaaT Pharma has developed two approaches for its oncology-focused therapies. The first relies on healthy donor donations ("native" products) and aims to restore the gut microbiota of patients with liquid tumors (notably leukemia). The second is focused on the development of "synthetic" microbiome therapies, which are co-fermented and are designed to colonize the patient’s gut with a functional microbiome to improve response to treatment in patients with solid tumors.

MaaT Pharma’s unique pharmaceutical drug development platform relies on advanced artificial intelligence data analysis tools and on a proprietary technology for the co-fermentation of microbial ecosystems to support the design, development, and large-scale manufacturing of novel Microbiome Ecosystem Therapies (MET).

The grant funding will support a key step in developing this platform, namely the industrialization and standardization of co-fermentation processes according to cGMP manufacturing standards, as well as the manufacturing of clinical batches. Ultimately, MaaT Pharma’s manufacturing platform may be used to deliver a large range of microbiome ecosystem therapies in various indications.

Accelerating the development of products in immuno-oncology

The MEPA program is a new step in Maat Pharma’s development as it supports the expansion of its indications to include solid tumors and the acceleration of its immuno-oncology program.

Recent studies have shown that the gut microbiome composition may improve the therapeutic effect of immune checkpoint inhibitors (ICI). In particular, a patient’s gut microbiome richness1 and diversity2 are predictors of their response to ICI3. Two pilot clinical studies also suggest that gut microbiota transfer from ICI-responding donors to non-responders can restore the response in the latter4.

With its therapies, MaaT Pharma aims to synthetically replicate a responder microbiota, combining high richness and diversity with selected functional networks in each indication of interest to improve the response to immune checkpoint inhibitors.

1 Total number of bacteria present in the gut
2 Total number of different strains present in the gut
3 Gopalakrishnan, V. et al, Science, 2018; Routy et al, Science 2018
4 Davar D. et al, Science 2021 ; Baruch E.N. et al, Science, 2021

Lantern Pharma Announces Significant Positive Preclinical Data in Pancreatic Cancer With Drug Candidate LP-184

On July 20, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that positive new data from its ongoing pancreatic cancer collaboration with the Pancreatic Cancer Institute at Fox Chase Cancer Center (Press release, Lantern Pharma, JUL 20, 2021, View Source;utm_medium=rss&utm_campaign=significant-positive-preclinical-data-lp-184 [SID1234584974]). Preclinical data demonstrated that the drug candidate, LP-184, demonstrated significant and rapid pancreatic tumor shrinkage, by over 90%, in in-vivo mouse models in 8 weeks. In comparison, the tumors in the untreated mice grew by over eleven-fold in volume during the same 8 week period.

Additional positive data on the efficacy and potency of LP-184 was gathered from 6 pancreatic cancer cell lines, and an additional 5 patient-derived xenograft (PDX) ex-vivo tumor models. Significant reduction of cancer cells and cancer cell growth was observed across all pancreatic cancer cell lines and PDX models that were tested in the study with IC50 values being in the nanomolar range (45-270 nM). These data and observations are being prepared for peer-reviewed publications, manuscripts and scientific conferences. Data from this study will be used to power future insights and analysis provided by Lantern’s A.I. platform, RADR , in addition to further enhancing the signature of response for LP-184 in pancreatic cancers. Lantern believes this to be a significant positive advancement for LP-184 in targeted pancreatic cancers and plans to advance the collaboration with Fox Chase Cancer Center into the next phase.

CRISPR knockout data confirmed the importance of PTGR1 in LP-184 cytotoxicity in pancreatic cancer, and validates the RADR-generated hypothesis that PTGR1 plays the leading role in orchestrating responsiveness of tumors to LP-184. The research conducted at Fox Chase Cancer Center leveraged CRISPR editing to silence the gene PTGR1 in pancreatic cancer cells — this resulted in virtually no-response by the pancreatic cancer cells to the drug. Those pancreatic cancer cells with PTGR1 expression (untouched by gene-editing) had heightened response to LP-184 causing cell death and IC50 values in the sub-100nM range. Lantern believes that using a defined genetic signature for patient selection can enhance the likelihood of clinical trial success and focus future clinical trials on those patients that will benefit most from the therapy.

The research has been conducted in collaboration with Dr. Igor Astsaturov, an established, NCI funded, physician scientist and co-leader of the Marvin & Conchetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center. Results demonstrated that LP-184 significantly and rapidly shrunk pancreatic cancer xenografts in mice, and after treatment with once weekly dosing at 3 mg/kg for 8 weeks, no tumors were present in 1 of 4 treated mice and in 3 of 4 mice the average size of remaining tumors was approximately 7% of the original tumor and 146-fold smaller than the untreated tumors.

Additional research was conducted with Dr. Astsaturov to further confirm the increased sensitivity to LP-184 in tumors that had damage to DNA repair pathways. It was observed that pancreatic tumors that harbored genetic alternations in the following DNA repair pathways — NER (nucleotide excision repair) and HR (homologous recombination) — had 2-fold increased sensitivity to LP-184. This observed data has implications in increasing the potential number of pancreatic cancer patients that can benefit from LP-184, and also in confirming prior Lantern research focused on aiming this drug-candidate at other cancers that have DNA repair pathway mutations. These could be mutations or deficiencies in genes such as: BRCA1, BRCA2, ATM, ATR, ERCC2, ERCC3, ERCC4, ERCC5, ERCC6, FANCD2, RAD51 and PALB2.

"These data mechanistically validate LP-184’s potential as a synthetic lethal agent in many HRD (homologous recombination deficient) and NERD (nucleotide excision repair deficient) cancers." stated Dr. Astsaturov. "As a result, these data may be highly supportive of a future role for LP-184 in a genetically-defined subset of pancreatic cancer."

Pancreatic cancer is an orphan disease and has a five-year survival rate of 7.9%. This means that only approximately 8 in 100 people will have survived for five years and beyond. The 10-year survival rate of the disease is 1%, meaning only approximately 1 in 100 people survive 10 years and beyond. Pancreatic cancer has among the lowest 5-year survival rate of any of the 22 common cancers. GLOBOCAN estimates that for pancreatic cancer there are approximately 490,000 thousand new cases of pancreatic cancer globally, with over 62,000 occurring in North America annually. Targeting a specific subset of pancreatic cancer patients that are genetically defined has the potential to increase beneficial therapeutic options for patients and may ultimately improve survival for those with this cancer.

"We are highly encouraged by the results of this preclinical research and look forward to reporting the full results at future scientific conferences and in publications," noted Dr. Kishor Bhatia, Lantern’s Chief Scientific Officer. "The study observed the significant and targeted anti-tumor effects of LP-184, even in pancreatic cancers that were resistant to standard-of-care drugs. Moreover, we also validated through the elegant work done with Dr. Astsaturov’s lab, by use of CRISPR-editing, that PTGR1 does directly link to the anti-tumor activity of LP-184. We expect that we will be able to exploit this biomarker mechanism in various tumors beyond pancreatic in the future."

Lantern believes that LP-184 acts by damaging DNA selectively in tumors that express high levels of the enzyme PTGR1 – which occurs in several solid tumors. Analysis with Lantern’s data platform, RADR, indicated that 35-40% of pancreatic cancer transcriptomes in clinical databases have elevated PTGR1 expression. Lantern has also begun discussions on the design of first-in-human clinical studies for LP-184 in collaboration with Dr. Igor Astsaturov and other key opinion leaders in the pancreatic cancer treatment landscape. Lantern plans on initiating IND (Investigational New Drug) application enabling animal studies later this year, and Phase 1 human trials following the filing of a future IND application.