On May 12, 2022 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported financial results for the first quarter ended March 31, 2022 and provided corporate updates (Press release, Aravive, MAY 12, 2022, View Source [SID1234614384]).

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"During the first quarter we continued to advance the development of batiraxcept for the potential treatment of ovarian, kidney and pancreatic cancer, successfully raised additional capital and strengthened the management team," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "Our registrational Phase 3 trial of batiraxcept in ovarian cancer continues on pace to complete enrollment in 2022, with top line data anticipated in 2Q’23 and a potential BLA filing with the FDA in 4Q’23. Our ongoing Phase 2 trial of batiraxcept in clear cell renal cell carcinoma also continues to successfully enroll patients across three cohorts and the Phase 1b trial of batiraxcept in pancreatic cancer completed enrollment in 1Q’22. Updated results are anticipated throughout 2022. We remain encouraged by the continued signals of best-in-class potential of batiraxcept and look forward to providing continued clinical updates on each of our three active programs throughout 2022."

Recent Corporate Highlights

Batiraxcept in Platinum Resistant Ovarian Cancer (PROC): The registration-directed Phase 3 program of batiraxcept in combination with paclitaxel in PROC remains on track to complete enrollment in 2H’22. Topline data from the trial is anticipated to be available in 2Q’23. CMC work related to the PROC program remains on track with the goal of filing a BLA in 4Q’23. The global, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating efficacy and tolerability of batiraxcept at a dose of 15 mg/kg in combination with paclitaxel versus placebo in combination with paclitaxel. The trial aims to enroll 350 platinum resistant, high-grade serous ovarian cancer patients who have received 1-4 prior lines of therapy.

Batiraxcept in Clear Cell Renal Cell Carcinoma (ccRCC) and Serum-Based Biomarker: The Company dosed first patient in the Phase 2 study of batiraxcept in combination with cabozantinib in 2L+ ccRCC trial in January 2022. Enrollment across the three patient cohorts of the Phase 2 study continues on pace for planned completion and updated data releases during 2Q’22. The Company anticipates providing clinical updates on the Phase 2 study throughout 2022. In March 2022, the Company announced new biomarker data from the Phase 1b portion of the trial in patients with ccRCC. Aravive had previously reported an observable correlation of baseline levels of serum soluble AXL (sAXL)/GAS6 to clinical activity in its Phase 1b PROC trial. As such, one of the objectives of the ongoing Phase 1b/2 ccRCC trial is to evaluate the correlation of baseline sAXL/GAS6 with radiographic response in patients with ccRCC treated with batiraxcept plus cabozantinib. The Company continues to engage the US FDA about utilizing the biomarker as a basis for an accelerated development strategy. Updated biomarker data is anticipated in 2022.

As of April 30, 2022, 26 patients with ccRCC were treated with batiraxcept in the Phase 1b portion of the trial at doses of 15 mg/kg (n=16) and 20 mg/kg (n=10), plus cabozantinib 60 mg daily in previously treated (2L+) patients with ccRCC. There were no dose limiting toxicities observed at either dose and 14 of the 26 patients remain on study. The best overall response rate (ORR, confirmed + unconfirmed) in the ITT population was 46% and 50% in patients dosed with 15 mg/kg (the recommended Phase 2 dose). The best ORR in the biomarker high population was 60%, and 67% in the biomarker high population dosed at 15 mg/kg. The 7-month progression-free survival (PFS) rate was 71% in the ITT population, 83% in the biomarker high population, and 91% in the 15 mg/kg biomarker high group. Eight patients experienced resolution of one or more target lesions. The company is on track to report additional updated results from the Phase 1b portion of the trial in the second quarter of 2022.

Batiraxcept in Pancreatic Adenocarcinoma: In January 2022, Aravive completed enrollment of the Phase 1b portion of its Phase 1b/2 trial of batiraxcept in combination with gemcitabine and nab-paclitaxel as a first-line treatment in patients with advanced or metastatic pancreatic adenocarcinoma who are eligible to receive gemcitabine and nab-paclitaxel combination therapy. As of May 3, 2022, 21 patients have been treated with 15 mg/kg batiraxcept in combination with gemcitabine and nab-paclitaxel as a first-line treatment. Batiraxcept has been generally well-tolerated with no unexpected safety signals. The best ORR (confirmed + unconfirmed) was 29%. As noted with the other programs, an observable correlation of baseline levels of serum soluble AXL (sAXL)/GAS6 to clinical activity was noted in this trial as well and the best ORR in the biomarker high population was 40%. Five patients experienced resolution of one or more target lesions; however, 2 of these patients have since progressed. The company is on track to report additional updated data from the Phase 1b portion of the trial in the second quarter of 2022.
Strengthened Balance Sheet: In January 2022, Aravive raised approximately $10.0 million from the sale of a pre-funded warrant to purchase 4,545,455 shares of the company’s common stock to Eshelman Ventures, LLC at a price of $2.20 per share, which was the consolidated closing bid price of the company’s common stock on The Nasdaq Global Select Market on December 31, 2021. Additionally, Fred Eshelman, Pharm.D., was appointed the Executive Chairman of Aravive, having served as the Non-Executive Chairman of the board since April 2020. In March 2022, the Company raised an additional approximately $10.0 million from the sale of common stock and a pre-funded warrant for an aggregate of a combination of 4,850,241 shares of the company’s common stock and pre-funded warrants to a single healthcare-focused institutional investor and Eshelman Ventures, LLC and issued warrants to purchase an additional aggregate of 4,850,241 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules. Combined, the additional capital infusions strengthen the Company’s financial position and fund operations as currently planned into 1Q’23.
First Quarter 2022 Financial Results
Revenue for the three months ended March 31, 2022 was $1.1 million compared with $0.3 million for the same period in 2021. Revenues were derived solely from the Company’s collaboration and license agreement with 3D Medicines, executed in November 2020 to develop and commercialize batiraxcept in oncology indications in Greater China. Revenues represent a portion of initial signing and milestone payments received from 3D Medicines that is recognized at the time of the receipt and a portion of the payments that is deferred and recognized over the PROC trial period.

Total operating expenses for the three months ended March 31, 2022 were $16.1 million compared with $8.3 million for the same period in 2021. Total operating expenses for the three months ended March 31, 2022 included non-cash stock-based compensation expense of $0.6 million, compared to $0.5 million for the same period in 2021.

For the three months ended March 31, 2022, Aravive reported a net loss of $13.1 million, or $0.62 per share compared to a net loss of $8.0 million, or $0.44 per share for the same period in 2021.

Cash Position
As of March 31, 2022, cash and cash equivalents were $65.8 million, compared to $59.4 million as of December 31, 2021. In January 2022, Aravive announced an approximately $10.0 million investment by Eshelman Ventures and in March 2022, Aravive announced an additional approximately $10 million investment by a healthcare-focused institutional investor and Eshelman Ventures, LLC. The company anticipates that its current cash and cash equivalents will fund operating plans into 1Q’23.

On May 12, 2022 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported financial results for the first quarter ended on March 31, 2022 (Press release, Scynexis, MAY 12, 2022, View Source [SID1234614404]).

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"Our Commercial organization is making solid progress toward bolstering prescription trends, and we are seeing the results of those concerted efforts," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We recently strengthened our balance sheet, which enables us to enhance our commercial efforts in VVC and continue our R&D activities into 2024, as we build a broad antifungal franchise for ibrexafungerp across multiple indications."

BREXAFEMME Commercial Update

BREXAFEMME delivered $0.7 million in net sales in first quarter 2022. According to IQVIA data, there were approximately 4,000 total prescriptions for BREXAFEMME written in Q1 2022. Total prescriptions have continued to grow in 2022 with 1,070 in January, 1,328 in February and 1,579 in March.
BREXAFEMME was prescribed by over 1,800 unique healthcare professionals (HCPs) in the first quarter, and 55% of these doctors expanded their use and prescribed the treatment to multiple patients during this period, up from 40% last quarter.
Commercial insurance coverage of BREXAFEMME continues to expand. As of April 2022, BREXAFEMME was covered by plans representing more than 93 million or 55% of commercially-insured lives.
Ibrexafungerp Clinical Updates

Reported positive results from the fourth interim analysis of the FURI and CARES trials highlighting oral ibrexafungerp’s potency against severe fungal infections. The recent interim analyses included 39 new cases from FURI and eight new cases from CARES who completed treatment during the 12 months since the prior interim analyses. In the combined analysis of 131 patients, 83.2% of patients demonstrated a clinical response to oral ibrexafungerp. Of the 131 FURI and CARES study cases analyzed to date, 61.1% achieved a complete or partial response, or clinical improvement; and 22.1% achieved stable disease, which is a favorable outcome in patients with severe progressive fungal infections.

Reported positive results from the pivotal Phase 3 CANDLE study of oral ibrexafungerp for prevention of rVVC. In this international trial of 260 patients with rVVC, defined as three or more episodes of vulvovaginal candidiasis (VVC) in the previous 12 months, patients initially received a three day regimen of fluconazole to treat their current infection, and responders were randomized in the prevention phase to receive either 300 mg ibrexafungerp BID or matching placebo one day a month, for six months. The study showed that 65.4% of patients receiving ibrexafungerp achieved clinical success by having no recurrence at all, either culture-proven, presumed or suspected, through Week 24 compared to 53.1% of placebo-treated patients (p=0.02). The advantage of ibrexafungerp over placebo was sustained over the three-month follow-up period and remained statistically significant (p=0.034). Ibrexafungerp was generally safe and well-tolerated. There were no serious drug-related adverse events, and no patients treated with ibrexafungerp discontinued therapy due to adverse events. The most commonly reported events were headaches and gastrointestinal events, which were mostly mild and generally consistent with the current BREXAFEMME label. SCYNEXIS plans to submit the results in a supplemental NDA to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022 and anticipates receiving approval by year-end.
SCYNEXIS initiated MARIO, a global Phase 3 study to evaluate ibrexafungerp as an oral step-down treatment for invasive candidiasis (IC) in the hospital setting. Company anticipates enrolling the first patient by the end of Q2 2022.
Following the positive Phase 1 data with the IV formulation reported previously, SCYNEXIS has begun to scale up manufacturing to enable additional IV trials.
Ibrexafungerp Scientific Presentations and Publications

Presented several posters highlighting details from interim analyses of data from its ongoing Phase 3 FURI and CARES studies investigating the potential of ibrexafungerp as a treatment for invasive candidiasis (IC) and candidemia, including infections caused by Candida auris (C. auris). The posters were presented at the 32nd Annual European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) held in Lisbon, Portugal April 23-26, 2022. Posters included:

An interim analysis of the CARES study of 18 enrolled patients with candidemia and other infections caused by Candida auris (C. auris) treated for a mean duration of 18 days, 78% of patients showed complete or partial response and 11% had stable disease.

An interim analysis with combined data of 49 patients with invasive candidiasis and candidemia from the ongoing Phase 3 FURI (n=39) and CARES (n=10) studies. Aggregate data from the two studies showed that of the patients treated with ibrexafungerp, 68% had complete or partial response and 14% had stable disease.

Data presented from an in vivo mouse model of mucormycosis found that ibrexafungerp monotherapy demonstrated in vivo efficacy in treating both Rhizopus delemar and Mucor circinelloides infections in mice, consistent with other antifungals currently used against mucormycosis. Additionally, the study found that when ibrexafungerp was combined with liposomal amphotericin B (LAMB) or posaconazole (POSA), synergistic benefits were observed with a significant enhancement in median survival time and overall survival when compared to any one therapy alone (p<0.05).

Reported new positive outcomes in patients with refractory vulvovaginal candidiasis (VVC) treated with oral ibrexafungerp from the ongoing Phase 3 FURI study. The new interim analysis was presented during the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting held in San Diego May 6-8, 2022. Ibrexafungerp showed positive results in difficult-to-treat VVC patients with severe fungal infections who were either intolerant to standard antifungal therapy or experienced refractory infections despite treatment. Of the 14 patients in the FURI study with refractory or relapsed cases of VVC treated with ibrexafungerp, 10 (71.4%) had successful clinical outcomes as judged by an independent Data Review Committee. Patients with VVC received 750 mg of oral ibrexafungerp (375 mg twice a day) every 72 hours for a total of three dosing days (Day 1, Day 4 and Day 7). In the study, ibrexafungerp was generally safe and well-tolerated with findings consistent with the existing product label.
Corporate Developments

SCYNEXIS raised gross proceeds of $45 million gross ($42 million net) in an April 2022 public offering of common stock, pre-funded warrants, and warrants.
SCYNEXIS received $4.7 million in non-dilutive proceeds in February 2022 from the sale of New Jersey State net operating losses to a third party.
SCYNEXIS received an additional $5.0 million in non-dilutive proceeds in March 2022 from the third tranche of the previously reported Term Loan Agreement with Hercules Capital/SVB upon achieving positive results from the Phase 3 CANDLE study of ibrexafungerp for the prevention of recurrent yeast infections.
First Quarter 2022 Financial Results

BREXAFEMME generated net product revenue of $0.7 million in the first quarter of 2022. The product was approved for sale by the FDA in June 2021 and launched in September 2021.

Cost of product revenue was $100,000 in the first quarter of 2022.

Research and development expense for the first quarter of 2022 decreased to $5.7 million from $6.9 million versus the first quarter of 2021.

Selling, general & administrative (SG&A) expense for the first quarter of 2022 increased to $14.6 million from $6.7 million versus the first quarter of 2021. The increase was primarily driven by an increase in costs recognized to support the ongoing commercialization of BREXAFEMME.

Total other income was $9.6 million for the first quarter of 2022, versus total other expense of $2.0 million for the first quarter of 2021. During the first quarters of 2022 and 2021, SCYNEXIS recognized non-cash gains of $10.0 million and $1.3 million, respectively, on the fair value adjustment of the warrant liabilities and non-cash gains of $1.0 million and non-cash losses of $0.1 million, respectively, on the fair value adjustment of derivative liabilities.

Net loss for the first quarter of 2022, was $5.5 million, or $0.17 basic loss per share, compared to net loss of $4.7 million, or $0.18 basic loss per share for the first quarter of 2021.

Cash Balance

Cash and cash equivalents totaled approximately $95.2 million on March 31, 2022, compared to $104.5 million in cash and cash equivalents on December 31, 2021. Based upon its current operating plan, SCYNEXIS believes that its existing cash and cash equivalents, the net proceeds received from the April 2022 public offering, and the anticipated sales of BREXAFEMME will enable the Company to fund its operating requirements into Q1 2024.

Conference call and webcast details

Webcast: View Source;tp_key=e943d8c4f4

About Ibrexafungerp

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The U.S. Food and Drug Administration (FDA) granted ibrexafungerp Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

On May 12, 2022 Ultivue, Inc., an industry leader in multiplexing assays and analytics solutions for tissue biomarker studies, reported multiple collaborations for AI-powered spatial phenomics solutions for translational research groups and Biopharma (Press release, Ultivue, MAY 12, 2022, View Source [SID1234614422]).

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Ultivue develops unique workflows for use in both multiplex immunofluorescence (mIF) imaging and spatial phenomics. Its proprietary InSituPlex technology is designed for fast and comprehensive exploration of biologically relevant targets, up to 12-plex, with same slide-H&E analysis in precious tissue samples. It combines the power of computational pathology & spatial biology to guide translational science in immuno-oncology.

Image and data analysis of rich spatial information from mIF images can accelerate tissue biomarker discovery and validation. Different capabilities are needed depending on the scientific question under investigation, the size of cohorts and the stage of the biomarker development program. Ultivue is complementing its own Image Data Services with capabilities provided by trusted partners to offer end-to-end support for customers. Flexible image analysis solutions as provided by Visiopharm and Indica Labs can effectively be used to provide rich readouts from bespoke mIF assays developed to address a scientific question. These solutions can be used at Ultivue, by the customer or at OracleBio – in GCP-compliant workflows. Co-marketing agreements with Aignostics, Keen Eye, and Nucleai, enable Ultivue to offer AI solutions that optimally complement mIF assays for the efficient analysis of larger cohorts. Hands-on time per image and consistency of readouts can be significantly improved and results can be reviewed in web-based viewers – a viewer optimized for mIF and same-slide H&E has been co-developed with Aignostics. Ultivue is also collaborating with Paige to bring AI-based analytics into clinical workflows and with Zegami leveraging AI to interactively explore image and analysis data from large cohorts for quality control and scientific interpretation.

All these agreements enable Ultivue to present a cohesive workflow to biopharma customers that combines the power of mIF and AI development ensuring a seamless integration of assay coupled to analysis. As noted by Florian Leiss, VP Digital Health Strategies, "Leveraging the full potential of mIF and AI for translational science and in clinical trials will require different capabilities at different stages. We are excited to work with trusted partners to complement mIF assays with image and data analysis across the entire spectrum of tissue biomarker development. We jointly accelerate the journey for our biopharma customers and enable them to focus on the science in a way no single player could alone."

On May 12, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported financial results for the first quarter ended March 31, 2022 and provided an update on recent business events (Press release, CorMedix, MAY 12, 2022, View Source [SID1234614469]).

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Recent Corporate Highlights:

CorMedix announced on March 28 that the resubmission of the DefenCath NDA has been accepted for filing by the FDA as a complete Class 2 response, with a six-month review cycle. In addition, our third-party manufacturer was notified that FDA will conduct an inspection during the review period.
CorMedix announced on April 7 that the Company formed a new Scientific Advisory Board to support commercialization of DefenCath as well as pipeline development.
CorMedix announced on May 12 several updates to the leadership team, including that Joe Todisco officially joined the organization as CEO on May 10 and that CorMedix has hired a new Head of Global Quality and an experienced Supply Chain leader.
CorMedix also announced on May 12 that the Company will begin the process of winding down its European operations and will discontinue the distribution of Neutrolin in the EU as CorMedix intends to focus near-term efforts on securing NDA approval for, and commercialization of, DefenCath in the US market.
Cash and short-term investments, excluding restricted cash, at March 31, 2022 amounted to $61.7 million.
Joe Todisco, CorMedix CEO, commented, "We are very pleased to share the updates this week regarding the business and plans for commercialization. If approved by FDA, DefenCath has the potential to meaningfully improve patient outcomes while also having an impact on the health equity disparity that is pervasive in our healthcare system. We look forward to providing additional updates as we aim to deliver on our commitment to these patients."

First Quarter 2022 Financial Highlights

For the first quarter of 2022, CorMedix recorded a net loss of $7.0 million, or $0.18 per share, compared with a net loss of $7.2 million, or $0.20 per share, in the first quarter of 2021, a decrease of $0.2 million, driven by a decrease in operating expenses.

Operating expenses in the first quarter 2022 were $7.0 million, compared with $7.2 million in the first quarter of 2021, a decrease of approximately 3%. The decrease was driven by lower R&D expense, which decreased by 13% to $2.3 million, primarily due to net decreases in personnel expenses and non-cash charges for stock-based compensation, offset by an increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval. SG&A expenses increased approximately 3% to $4.8 million, primarily driven by increased legal fees mainly due to the securities litigation, and an increase in personnel expenses, partially offset by a decrease in non-cash charges for stock-based compensation, and reduced costs related to market research in preparation for the potential approval of DefenCath.

The Company reported cash and short-term investments of $61.7 million at March 31, 2022, excluding restricted cash. The Company believes that it has sufficient resources to fund operations at least through the first half of 2023.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, May 12, 2022, at 4:30PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

On May 12, 2022 Crown Bioscience and Medical & Biological Laboratories (MBL), JSR Life Sciences companies, reported the formation of a joint venture, to further expand the provision of Crown Bioscience’s preclinical services to Japanese customers (Press release, Crown Bioscience, MAY 12, 2022, View Source [SID1234614267]).

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The new entity named "Crown Bioscience & MBL", is a long-term strategic partnership that is expected to accelerate growth for both companies. The initial focus is to provide preclinical and translational services to expand Crown Bioscience’s offerings in Japan. The agreement will enhance Crown Bioscience’s current distributor model and establish a local presence to ensure premium service delivery in Japan.

Based in Tokyo, Crown Bioscience & MBL will establish a local team led by an experienced General Manager, Hiroki Itou, Executive Officer of MBL and General Manager, Diagnostic & Research Reagents Department at JSR.

The new company will leverage each organisations’ respective areas of excellence and expertise, combining Crown Bioscience’s world-class preclinical and translational service capabilities with MBL’s deep knowledge and experience of the Japanese pharmaceutical market. The company, established in April 2022, is expected to initiate services from September 2022.

Commenting on the establishment of the new company, Armin Spura PhD, CEO of Crown Bioscience, noted that the agreement will extend and deepen the current partnership with MBL. He said: "Japan will play a significant part in Crown Bioscience and MBL’s long-term strategic vision. Our new company has been created to better serve the evolving needs of the Japanese biopharmaceutical community, and to serve our Japanese customers more effectively. I am excited to further develop our synergies with MBL – a trusted partner in the Japanese life sciences sector."

Hiroki Itou, President of Crown Bioscience & MBL commented: "Our two companies share a deep respect and identical values in the way we conduct business. I am confident that together we will be able to provide a unique and innovative portfolio of services that will accelerate drug discovery and development in Japan."