On September 10, 2020 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported presentations at the following conferences during the month of September (Press release, Exicure, SEP 10, 2020, View Source [SID1234564969]):

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TIDES: Oligonucleotide & Peptide Therapeutics
Panel discussion: The impact of technological advances in the TIDES Space
Presented by: CEO David Giljohann
Tuesday, September 15, 2020

Panel Discussion: Streamlining the transition from discovery to manufacturing
Presented by: Vice President of Translational Research Weston Daniel
Tuesday, September 15, 2020
H.C. Wainwright 22nd Annual Global Investment Conference
Corporate update
Presented by: CEO David Giljohann
Tuesday, September 15, 2020 at 1:00pm ET
Replays of the H.C. Wainwright webcast will be available on Exicure’s website for 90 days following the webcast.

On September 10, 2020 Selvita (WSE: SLV), one of the largest preclinical contract research organizations in Europe, reported its H1 2020 financial results and provided a corporate update (Press release, Selvita, SEP 10, 2020, View Source [SID1234564985]).

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For the H1 2020, Selvita reports consolidated revenues of EUR 15.2 million, up by 47% on a year-on-year basis. The EBITDA result reached EUR 3.6 million, compared to EUR 2.4 million a year earlier. The backlog for 2020, as of September 7, amounts to EUR 27.6 million and indicates an increase of 39%, as compared to the values reported a year ago.

The Company consistently develops its business activities and strengthens its position on the global preclinical CRO market, especially among the U.S. customer base, considered the world’s largest biotechnology market.

Commercial revenues in the Services Segment increased in H1 2020 to EUR 12.5 million, showing a 51% increase, compared to EUR 8.6 million in the corresponding period last year. The EBITDA result of the Services Segment amounted to EUR 3.2 million, which indicates a 23.8% profitability.

Revenues in the Bioinformatics segment (Selvita’s subsidiary – Ardigen S.A.) amounted to EUR 2.0 million in 1H 2020, indicating a 43% increase compared to the same period last year. The EBITDA result increased by 217% and amounted to EUR 0.4 million, with a margin of 20,1%.

The Company’s net profit in the first half of the year amounted to EUR 2.1 million, compared to EUR 1.1 million for a corresponding period last year.

The first half of 2020 was a very intensive period for Selvita in terms of corporate and business development. The Company announced a new development strategy for 2020-2023, successfully raised over EUR 20 million from the issue of C series shares, and consequently increased its scale of business.

– We’re consistently implementing the assumptions of the development strategy, which directly translate into strengthening of our market position, as well as a solid operational and financial result. The first half of 2020 confirms that the global preclinical CRO market continues to grow and diversify, despite the uncertainties caused by the COVID-19 pandemic. For Selvita, it was a very strong half-year, as, despite the global situation and instabilities, we managed to strengthen our position on international markets, especially among U.S. based customers – comments Boguslaw Sieczkowski, Chief Executive Officer at Selvita.

Revenues from the services commissioned by U.S. customers increased almost three times by 279% y/y, and already constitute nearly 28% of the entire Services Segment revenues. At the same time, revenues from the services commissioned by customers from the United Kingdom increased by 63% y/y. Increasing customer recognition is related to the high quality of services offered and highly competent teams of specialists, which results in further contracts.

Continuity of our business operations has been assured with numerous preventive measures across our entire organization that have been taken in order to keep our scientists safe and the Company fully operational. Despite the restrictions placed on international travel, we are keeping our sales and networking activities going, which has successfully translated into the signature of numerous new contracts, as evidenced by our record-breaking backlog – adds Boguslaw Sieczkowski.

At the end of April 2020, Selvita announced its new development strategy for 2020 – 2023, which assumes increasing revenues, maintaining a stable EBITDA margin, and over EUR 230 million of market cap in 2023. For this purpose, in 2020-2023, the Company intends to execute investments worth up to EUR 75-90 million, allocated to acquisitions and organic development. In order to complete the strategy, Selvita raised over EUR 20 million in its Follow-On public offering from the issue of C series shares. Approximately 80% of the proceeds will be allocated to acquisitions, on which the Company is currently intensively working on. One of the elements of the strategy execution will be the creation of the Selvita Research Center in order to secure its own research space necessary for further growth. The Company has already made the first step towards executing this goal and signed a contract to purchase a plot of land in the neighborhood of its current laboratories in August 2020 for the value of EUR 2,3 million.

* Percentage changes in the press release are calculated based on functional currency [PLN].

On September 10, 2020 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported the financial results for Nicox and its subsidiaries (the "Nicox Group") for the six months ending June 30, 2020 and provided an update on its activities as well as key upcoming milestones (Press release, NicOx, SEP 10, 2020, View Source;text=Operating%20expenses%20for%20the%20first,the%20same%20period%20in%202019. [SID1234564917]).

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Michele Garufi, Chairman and Chief Executive Officer of Nicox, said: "We are very pleased with the excellent progress in the Mont Blanc trial recruitment and the preparation for initiation of the Denali trial, together with our Chinese partner Ocumension, in Q4 2020. Additional support for these activities has come from the non-dilutive financing strategy we have implemented since March which includes the expansion of our collaboration with Ocumension, as well as the divestment of our VISUfarma shareholding in July. As one of the few European R&D companies having two products commercialized in the United States, with expansion in many other markets ongoing, we also expect to see recurrent royalty revenue steadily increasing in the years ahead and contributing to the future growth of the company. With this revenue, and the non-dilutive financing, we believe that the company is now financed to complete the NCX 4251 Phase 2b trial planned to start later this year and beyond the top-line results from the Mont Blanc trial."

Key Expected Upcoming Milestones

·NCX 470 Mont Blanc Phase 3 clinical trial: The first Phase 3 trial of NCX 470 for lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension has an initial adaptive design portion designed to select the optimal dose of NCX 470 which will then continue into a subsequent head-to-head 3-month safety and efficacy evaluation vs. latanoprost. With the recently announced completion of enrolment of the adaptive cohort, the trial is on track for that selection of optimal NCX 470 dose in the coming weeks. The completion of the adaptive design portion will also enable the start of the second Phase 3 trial, or the Denali trial, before the end of 2020.

NCX 470 Denali Phase 3 clinical trial: The second Phase 3 glaucoma clinical trial, Denali, which is jointly managed and funded equally by Nicox and Ocumension, is currently expected to start in Q4 2020. The Denali trial will include clinical sites in both the U.S. and China, with the majority of the patients being in the U.S. The Denali trial was designed to fulfill the regulatory requirements to support NDA filings in the U.S. and China.
NCX 4251 Phase 2b clinical trial: This Phase 2b trial, Mississippi, will include both blepharitis and dry eye endpoints with the option of declaring either the blepharitis or dry eye endpoints as the primary efficacy outcome of the trial. The trial is planned to be initiated before the end of 2020.
ZERVIATETM China: A Phase 3 clinical trial intended to support an application for regulatory approval in China, to be conducted and financed by our partner Ocumension, is currently expected to start by the end of 2020.
·Nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitors for IOP lowering: IND-track candidate expected to be announced by the end of 2020.

We continue to closely watch the spread of COVID-19 and its impact. We do not currently anticipate delays to our clinical timelines but we are monitoring the situation and will provide updates if there is an impact on our development projects and timelines.

Nicox Secures €2 Million in a Non-Dilutive Loan Facility Guaranteed by the French State

In the third quarter 2020 we entered into a €2 million credit agreement, granted by Société Générale and LCL and guaranteed by the French State, in the context of the COVID-19 pandemic. This non-dilutive financing contributes to strengthening the Company’s cash position. This loan is not secured against any of the Company’s assets. Up to 90% of the loan is guaranteed by the French State. It has an initial maturity of 12 months with the option for Nicox to take a 1 to 5-year repayment period after that.

Strengthening Development Management

We appointed Sushanta Mallick, Ph.D., to a position of Vice President of External Development, effective August 1, 2020. In this position, Dr. Mallick will be the development lead for our key collaborations and will also oversee a subset of clinical development activities. He brings over 25 years of ophthalmology development experience including senior roles with Alcon, QLT, Aerie and Shire, and will report to Tomas Navratil, Ph.D., EVP & Head of R&D of the Nicox Group and General Manager of Nicox Ophthalmics, Inc.

First Half 2020 Financial Highlights

Net revenue1 for the first half of 2020 was €2.4 million (including €1.0 million in milestone revenue) versus €5.6 million (including €4.7 million in upfront and milestone revenue) for the first half of 2019. Operating expenses for the first half of 2020 were €10.2 million compared to €11.4 million for the first half of 2019.

The Nicox Group recorded a net loss of €14.6 million for the six months ended June 30, 2020, compared to a net loss of €0.8 million for the same period in 2019. This difference is mainly explained by the fact that, pursuant to accounting principles, €14 million of the €15 million upfront received from Ocumension in H1 2020 are not taken into consideration as they are recorded as deferred revenues (included in "contract liabilities" in the statement of financial position) and further by a non-cash value adjustment of €6.9 million on VISUfarma assets successfully divested in July to strengthen Nicox’s cash position. Moreover, the net loss in the first half of 2019 was reduced thanks as well to the recognition of a non-cash income of €3.8 million for deferred tax assets recognized by our U.S. subsidiary.
As of June 30, 2020, the Nicox Group had cash and cash equivalents of €40.4 million, adjusted on a pro forma basis to €45.4 million including the €5 million received in July from the sale of our shareholding in VISUfarma, as compared with €45.2 million at March 31, 2020 and €28.1 million at December 31, 2019.
As of June 30, 2020, the Nicox Group had financial debt of €17.7 million in the form of a bond financing agreement with Kreos Capital signed in January 2019. Full details of the bond financing agreement can be found in the Press Release of January 25, 2019 – View Source
Only figures at December 31, 2019 are audited, all other figures of this press release are non-audited.

Notes
1. Net revenue consists of revenue from collaborations less royalty payments which we refer to as net profit from collaborations in the condensed consolidated statements of profit or loss for the six-month period ended June 30, 2020.

On September 10, 2020 Boehringer Ingelheim reported the advancement of the bi-specific and tetravalent therapeutic antibody, BI 905711, to its first-in-human clinical trial for patients with advanced gastrointestinal (GI) cancers (Press release, Boehringer Ingelheim, SEP 10, 2020, View Source [SID1234564934]). The first-in-class BI 905711 antibody is designed to recognize both the pro-apoptotic tumor necrosis factor (TNF)-related apoptosis-inducing ligand receptor 2 (TRAILR2) and the tumor cell anchor cadherin 17 (CDH17) to activate the self-destruction (apoptosis) pathway in co-expressing tumor cells found mostly in the GI tract. For patients suffering from these types of cancers, the advancement of the Phase 1 trial marks an important milestone in the continuing development of more tolerable innovative therapies to address diseases with high unmet need.

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"We are proud to advance BI 905711 into Phase 1 clinical trials as we continue to grow our oncology pipeline to transform patients’ lives. This bispecific platform has the potential to target complex mechanisms that may not be accessible with traditional antibody formats," said Norbert Kraut, Ph.D., Head of Global Cancer Research at Boehringer Ingelheim.

Gastrointestinal cancers are a leading cause of cancer-related deaths throughout the world. Of gastrointestinal cancers, colorectal cancer, a focus of this Phase 1 trial, is the third most common cancer with more than 1.8 million cases and the second most deadly cancer with more than 880,000 deaths globally in 2018 (Globocan 2018).¬ To date there have been few innovative treatment options available for patients diagnosed with GI malignancies, making chemotherapy, despite its known severe side effects, the backbone of treatment. A proven targeted therapeutic option that does not require chemotherapy efficacy support could provide patients with an alternative, innovative and potentially non-toxic treatment option.

James Harding, M.D., Principal Investigator, Department of Early Drug Development and Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center, New York, USA, said, "Targeting TRAILR2/CDH17 co-expressing cancer cells has exhibited preclinical antitumor activity. We look forward to evaluating this molecule with Boehringer Ingelheim in the ongoing Phase 1 study."

Patients with tumors of the gastrointestinal tract are underserved by recent innovations in cancer therapy and are in critical need of new treatment options. Boehringer Ingelheim is committed to addressing the unmet need in these patients’ lives and continues to develop innovative drug candidates, such as BI 905711, providing potentially powerful and previously untested approaches to cancer treatment.

Boehringer Ingelheim Oncology is taking cancer on by leading the science with cancer cell directed agents, immuno-oncology therapies, and their combinations to address unmet needs in lung and gastrointestinal cancers. The company invests significantly in early stage research to identify unexplored and undrugged pathways of cancer. In 2019, Boehringer Ingelheim advanced six molecules to first-in-human studies, including two further first-in-class compounds targeting the Wnt/β-catenin pathway (BI 905681) and KRAS-driven cancers (BI 1701963), demonstrating the company’s long term commitment to leading science, improving clinical practice, and ultimately transforming the lives of patients – helping them to win the fight against cancer.

On September 10, 2020 Orion Corporation reported that The New England Journal of Medicine has published the full overall survival (OS) results from the pre-specified final OS analysis of the Phase III ARAMIS trial for darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk for developing metastatic disease (Press release, Orion , SEP 10, 2020, View Source [SID1234564953]). These data were also presented as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program held in May 2020.

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"Through ongoing research, we have established the importance of focusing treatments on extending lives and limiting side effects for men living with nmCRPC. With these encouraging darolutamide results, physicians are further armed to treat based on the multiple needs of this patient population including efficacy, delaying morbidity and treatment tolerability," said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, Villejuif, France, and lead ARAMIS study investigator.

Men receiving darolutamide plus androgen deprivation therapy (ADT) demonstrated a significant improvement in OS compared to placebo plus ADT, with a 31 percent reduction in risk of death (HR=0.69, 95% CI 0.53-0.88; p=0.003). This OS benefit was observed despite more than half (55 percent) of patients in the placebo group (307 of 554 patients) receiving subsequent darolutamide or other life-prolonging therapy at data cut-off for final analysis (November 15, 2019).

With an extended follow-up of median 29 months for the overall study population, darolutamide continued to demonstrate a favorable safety profile. Discontinuation of treatment due to adverse events (AEs) was unchanged from the primary analysis, occurring in 9 percent of patients in both arms of the study.

This updated analysis of the ARAMIS trial also confirms the low potential for central nervous system (CNS) effects, such as mental impairment and cognitive impairment, expected with darolutamide plus ADT.

About the ARAMIS trial
The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with ADT and are at high risk for developing metastatic disease. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide orally twice daily or placebo along with ADT. Patients with a history of seizure were allowed in the study.

Previously published results from the ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months for darolutamide plus ADT compared to 18.4 months for placebo plus ADT (p<0.001).

About darolutamide
Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The compound is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS). Information about the trials can be found at www.clinicaltrials.gov.

Darolutamide was approved in March 2020 in the European Union (EU) under the brand name Nubeqa for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. Nubeqa has also received regulatory approval in the U.S., Australia, Brazil, Canada as well as Japan, and filings in other regions are underway or planned.