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Transgene: Major R&D Milestones Achieved in 2019 and Strong Clinical Activity In 2020

On March 11, 2020 Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its financial results for 2019 and provides an update on its product portfolio (Press release, Transgene, MAR 11, 2020, View Source [SID1234555425]).

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Philippe Archinard, Chairman and Chief Executive Officer of Transgene, commented:

"We achieved multiple important advances with our novel myvac and Invir.IO platforms during the course of 2019. We completed all the regulatory steps required to start the US and European clinical trials of TG4050, the first individualized therapeutic vaccine based on the myvac platform in January 2020. The clinical development is being co-funded by our partner NEC.

Our collaboration with AstraZeneca, based on our Invir.IO platform, is progressing well with the first multifunctional oncolytic viruses already being delivered to them. This platform has also generated a number of exciting new oncolytic candidates, including BT-001, which is being co-developed with BioInvent. The preclinical results generated with BT-001 have been remarkable and we are working hard to make sure we can take our first multifunctional Invir.IO oncolytic into the clinic before the end of 2020.

On the clinical front, we had a year of contrasts with on the one hand, the very encouraging initial results of TG4001, which were presented at ESMO (Free ESMO Whitepaper) 2019, and on the other hand, the disappointing outcome of the Phase 2 trial of TG4010 and the decision to stop Pexa-Vec trials in HCC.

We remain confident in the potential of our four clinical assets TG4001, TG4050, TG6002 and BT-001 as well as in our highly innovative technologies and platforms myvac and Invir.IO.

We also have sufficient financial visibility to pursue our developments with determination and confidence."

2020: multiple clinical milestones expected

Transgene’s portfolio currently consists of four immunotherapy drug candidates in clinical development:

Two therapeutic vaccines: TG4001 currently being evaluated in a Phase 2 trial and TG4050, the first individualized treatment based on the myvac platform, assessed in two Phase 1 trials.
Two oncolytic viruses: TG6002, which is being assessed in two Phase 1/2a trials, and BT-001, the first oncolytic virus based on the Invir.IO platform, and which is expected to enter the clinic before the end of 2020.
Clinical results for TG4001 and TG6002 are expected in the second quarter of 2020:

The Phase 2 trial of TG4001 in combination with avelumab in HPV-positive cancers is ongoing. Patient recruitment is in line with projections and interim results are expected in the second quarter of 2020.
The Phase 1 trial of TG6002 administered intravenously in patients with gastrointestinal cancers is ongoing. First data are also expected in the second quarter of 2020.
With myvac and Invir.IO, Transgene has two next-generation platforms whose potential has been validated by collaboration deals with NEC and AstraZeneca respectively:

myvac platform

Transgene is developing the therapeutic vaccine TG4050, together with NEC. This is the first individualized vaccine based on the myvac platform. It integrates NEC’s Artificial Intelligence technologies. These technologies are used to select the most relevant mutations (neoantigens) that are integrated into the TG4050 vaccine. These AI technologies will also contribute to the in-depth analysis of the patient’s immune characteristics, in order to determine the profiles of those who responded to the vaccine.
Data validating the vaccine design principle behind TG4050 are being actively promoted and will be presented at several specialized international congresses.
The first clinical trials assessing TG4050 are ongoing in Europe and in the United States. They are including patients with ovarian cancers and head and neck cancers. NEC is financing 50% of their cost.
The clinical trials are a central part of a broad program of translational research in collaboration with expert centers both in the US and Europe. This program will generate a significant body of data evaluating the activity of TG4050 from these initial clinical trials. The first data are expected in 1H 2021.
The Company has set up an in-house good manufacturing practice (GMP) unit dedicated to the manufacturing of the individualized batches of TG4050 needed for the current Phase 1 trials.
The myvac project is supported by Bpifrance, within the NEOVIVA program. The NEOVIVA project aims to strengthen the development of this highly innovative technology together with three partners: HalioDx, Traaser and Institut Curie. €2.6 million have been allocated to Transgene over five years. The NEOVIVA project is complimentary to the collaboration between Transgene and NEC.
Invir.IO platform

BT-001 is the first oncolytic virus from the Invir.IO platform. It is based on Transgene’s patented viral vector VVcopTK-RR- which has been designed to encode BioInvent’s anti-CTLA4 antibody (an immune checkpoint inhibitor) as well as the cytokine GM-CSF.
Preclinical results with BT-001 have been extremely promising, with treatment leading to the eradication of tumors in several murine models known for their low sensitivity to immune checkpoint inhibitors. These data will be presented at scientific congresses in the coming months. A first-in-human trial is being prepared and BT-001 is expected to enter the clinic before the end of 2020.
The collaboration with AstraZeneca is highly productive with Transgene already delivering the first multi-armed oncolytic viruses to its partner. As a result, Transgene has received $10 million at the time the collaboration was signed and booked €1.3 million related to the achievement of certain preclinical milestones. In 2020, Transgene will continue to design further oncolytic viruses for this collaboration. AstraZeneca can exercise an option to further develop each of these novel drug candidates.
Transgene’s patented viral vector, which underpins the Invir.IO platform, allows the development of a wide range of multifunctional oncolytic viruses. Transgene has already designed a number of proprietary oncolytic viruses that are being evaluated in preclinical models. A candidate is expected to be selected with the aim of submitting a clinical trial application in 2H 2020 ahead of starting a clinical trial in 2021.
Summary of key ongoing clinical trials

TG4001
+ Bavencio

(avelumab)
Phase 2

Targets: HPV16 E6 and E7 oncoproteins

HPV-positive cancers including oropharyngeal head and neck cancer – 2nd line

✓ Clinical collaboration with Merck KGaA and Pfizer, for the supply of avelumab

✓ Publication of the results of a Phase 2b trial of TG4001 in Gynecologic Oncology (April 2019), demonstrating the biological activity of this immunotherapeutic in CIN 2/3 lesions; editorial in The Lancet Oncology (April 2019)

✓ Positive results of the Phase 1b part of the trial presented at ESMO (Free ESMO Whitepaper) (Sept. 2019) Three of the six patients who received the recommended dose responded to the treatment. The observed responses were durable.

→ Interim Phase 2 results expected in 2Q 2020

myvac
TG4050
Phase 1

Targets: tumor neoantigens

Ovarian cancer – after first-line surgery and adjuvant therapy

✓ Trial authorized in the United States (May 2019) and in France (Sept. 2019)

✓ Principal investigator: Matthew Block (Mayo Clinic)

✓ First patient enrolled in January 2020

→ First data expected in 1H 2021

myvac
TG4050
Phase 1

HPV-negative head and neck cancer – after surgery and adjuvant therapy

✓ Trial authorized in the United Kingdom (July 2019) and in France (Sept. 2019)

✓ Principal investigator: Christian Ottensmeier (Southampton University)

✓ First patient enrolled in January 2020

→ First data expected in 1H 2021

TG6002
Phase 1/2a

Payload: FCU1 for the local production of a chemotherapy agent

Gastro-intestinal adenocarcinoma (colorectal cancer for Phase 2) – Intravenous (IV) route

✓ Publication in Molecular Therapy Oncolytics (March 2019) highlighting the promising activity of TG6002 in preclinical colorectal carcinoma models

✓ Multicenter trial ongoing in Belgium, France and Spain

✓ Last dose levels currently being evaluated (Phase 1 part)

→ First results of the Phase 1 part expected in 2Q 2020

TG6002
Phase 1/2a

Colorectal cancer with liver metastasis – Intrahepatic artery (IHA) route

✓ Multicenter trial authorized in the United Kingdom (July 2019)

✓ First patient treated in February 2020

→ First results expected in 1H 2021 (Phase 1 part)

Invir.IO
BT-001
Phase 1/2

Payload: anti-CTLA4 antibody and GM-CSF cytokine

Solid tumors

✓ Collaboration with BioInvent

✓ First clinical trial application submitted

→ Presentation of very encouraging preclinical results at upcoming scientific congresses

→ First clinical trial expected to start before the end of 2020

Key financials for 2019

Operating income of €13.7 million in 2019, compared to € 42.9 million in 2018.
R&D services for third parties amounted to €6.7 million in 2019 (€1.3 million in 2018). This significant increase is mainly due to the collaboration signed with AstraZeneca in 2019. This generated €5.3 million in revenue in 2019. The research tax credit amounted to €6.5 million in 2019 (€5.7 million euros in 2018). As a reminder, the much higher operating income figure in 2018 was mainly the result of the €35.6 million income generated by the transaction with Tasly Biopharmaceuticals Co, Ltd.
Net operating expenses of €39.2 million in 2019, compared to €35.5 million in 2018.
R&D expenses increased to €31.4 million in 2019 (from €27.3 million in 2018), due to the acceleration of external expenses for clinical projects and the setup of manufacturing unit dedicated to small clinical batches. General and administrative expenses stood at €7.1 million in 2019 versus €7.0 million in 2018.
Financial income of €6.7 million in 2019 versus a loss of €2.0 million in 2018.
The decision taken at the end of 2019 to stop the clinical development of TG4010 has led to a downward reassessment of the financial debt related to the repayable advances of the ADNA program of €8.7 million. This has been recognized as financial income.
Net loss of €18.8 million in 2019, compared to a net profit of €8.0 million in 2018.
Cash burn reduced to €20.5 million in 2019 (excluding the proceeds of the rights issue), versus €24.5 million in 2018.

Transgene received €8.9 million in June 2019, following the signing of the contract with AstraZeneca. This contributed to the reduced net cash burn compared to 2018 despite an increase in operating expenses during the period.
Cash available at year-end 2019: €43.3 million, compared to €16.9 million at the end of 2018, due to the successful €48.7 million rights issue completed in July 2019.
Transgene expects its cash burn for 2020 to be around €25 million.
The financial statements for 2019 as well as management’s discussion and analysis are attached to this press release (Appendices A and B).

The Board of Directors of Transgene met on March 11, 2020, under the chairmanship of Philippe Archinard and closed the 2019 financial statements. Audit procedures have been performed by the statutory auditors and the delivery of the auditors’ report is ongoing.

The Company’s universal registration document, which includes the annual financial report, will be available early April 2020 on Transgene’s website, www.transgene.fr.

A conference call in English is scheduled today, March 11, 2020, at 6:00 p.m. CET.

Excellere Portfolio Company, Biocare Medical, Hires Luis de Luzuriaga as CEO

On March 11, 2020 Biocare Medical ("Biocare"), a leading developer of world class immunohistochemistry ("IHC") and molecular reagents and instrumentation, is reported that Luis de Luzuriaga has joined the company as Chief Executive Officer (Press release, Biocare Medical, MAR 11, 2020, View Source [SID1234555424]).

Mr. de Luzuriaga has spent his entire career in commercial and executive leadership roles within the life sciences tools and diagnostics sector. Notably, Mr. de Luzuriaga spent six years leading Global Commercial Operations at Leica Biosystems and also served as the Divisional Vice President and General Manager of Abbott Hematology. Most recently, Mr. de Luzuriaga was the CEO of BIT Group (subsidiary of Messer Group), a leading product development and contract manufacturer for high performance clinical, medical and life science devices.

Mr. de Luzuriaga’s proven ability to drive extraordinary growth and industry leadership within the life sciences tools sector aligns well with Biocare’s strong growth trajectory and reputation for quality diagnostic tools focused on the oncology and immunotherapy markets. "Since our first interaction with Luis, it was clear that he had the experience, capabilities and expertise to propel Biocare to the forefront of the industry," said Ryan Glaws, Partner at Excellere Partners. "His extensive experience and impressive track record at Leica, Abbott and BIT make him the ideal partner to guide Biocare through this exciting and transformational period in the company’s history."

"I am excited to join Biocare and work with what I know to be both a dynamic and talented team. Having previously competed against Biocare, I know first-hand about the quality of the products and reputation in the marketplace. It is an honor and a privilege to lead this organization, and I am very excited about the future of Biocare," said Mr. de Luzuriaga.

Oncternal Therapeutics Announces Interim Clinical Data Update, Including 50% Complete Response Rate, for Cirmtuzumab in Combination with Ibrutinib in Patients with Mantle Cell Lymphoma

On March 11, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported an interim clinical data update for cirmtuzumab, a ROR1-targeted monoclonal antibody, combined with ibrutinib, in patients with relapsed/refractory mantle cell lymphoma (MCL) as part of the ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial (data cutoff as of March 6, 2020) (Press release, Oncternal Therapeutics, MAR 11, 2020, View Source [SID1234555423]):

50% Complete Response (CR) rate (6 of 12 evaluable patients), determined by Cheson criteria. One of the six patients had a complete metabolic response (CMR) by PET scan, with a bone marrow biopsy pending. All six CRs are ongoing, including one patient who has remained in CR at over 21 months on study. Four of the six patients achieved CRs within four months on the combination of cirmtuzumab and ibrutinib
33% Partial Response (PR) rate (4 of 12)
17% Stable Disease (SD) rate (2 of 12)
83% best Objective Response (CR or PR) rate (ORR)
100% Clinical Benefit (CR, PR or SD) rate
Median follow-up 6.4 months
Patients had received a median of two prior therapies before participating in this study including chemotherapy; autologous stem cell transplant (SCT); autologous SCT and CAR-T therapy; autologous SCT and allogeneic SCT; and ibrutinib with rituximab
The combination of cirmtuzumab plus ibrutinib has been well tolerated in this study, with adverse events consistent with those reported for ibrutinib alone. There were no dose-limiting toxicities, no discontinuations and no serious adverse events attributed to cirmtuzumab alone.

"The reported complete response rate for patients with MCL treated with cirmtuzumab and ibrutinib is highly encouraging and is higher than previously reported for ibrutinib alone, particularly considering that some of these patients were heavily pre-treated. Patients with relapsed MCL remain in dire need of well-tolerated treatment options that provide deeper and more durable responses," said Hun Ju Lee, M.D., Associate Professor of Medicine in the Department of Lymphoma & Myeloma at the University of Texas MD Anderson Cancer Center, who is an investigator on the CIRLL clinical trial.

The CIRLL clinical trial is supported by a grant from the California Institute for Regenerative Medicine (CIRM) and is being conducted in collaboration with the University of California San Diego (UC San Diego).

"We are encouraged by the complete response rate for patients with MCL reported in the ongoing CIRLL clinical trial, and look forward to further developing cirmtuzumab in the ongoing clinical trials for patients with MCL, chronic lymphocytic leukemia (CLL) and breast cancer, as well as potentially for other ROR1-expressing solid tumors and hematological malignancies," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO.

About the CIRLL Clinical Trial

The CIRLL clinical trial (CIRM-0001) is a Phase 1/2 trial evaluating cirmtuzumab in combination with ibrutinib in separate groups of patients with CLL or MCL. Enrollment of the dose-finding cohorts in CLL and MCL and dose-expansion cohort in CLL has been completed. Enrollment of the dose-expansion cohort in MCL and randomized Phase 2 cohort in CLL is ongoing. Based on the data from the dose-finding cohorts, the recommended dosing regimen was determined to be 600 mg of cirmtuzumab administered intravenously every two weeks for three doses, followed by dosing every four weeks, in combination with 420 mg of ibrutinib administered once daily for patients with CLL, or 560 mg of ibrutinib once daily for patients with MCL, which are the FDA-approved doses of ibrutinib in these indications. Additional information about the CIRM-0001 clinical trial and other clinical trials of cirmtuzumab may be accessed at ClinicalTrials.gov.

About Cirmtuzumab

Cirmtuzumab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Cirmtuzumab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of CLL or MCL, in a collaboration with the UC San Diego School of Medicine and the California Institute for Regenerative Medicine (CIRM). In addition, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women with metastatic breast cancer is being conducted at the UC San Diego School of Medicine.

ROR1 is a potentially attractive target for cancer therapy because it is an onco-embryonic antigen – not usually expressed on adult cells, and its expression confers a survival and fitness advantage when reactivated and expressed by tumor cells. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to specifically targeting ROR1 expressing tumors. This led to the development of cirmtuzumab, that binds this critical epitope of ROR1, which is highly expressed on many different cancers but not on normal tissues. Preclinical data showed that when cirmtuzumab bound to ROR1, it blocked Wnt5a signaling, inhibited tumor cell proliferation, migration and survival, and induced differentiation of the tumor cells. Cirmtuzumab is in clinical development and has not been approved by the U.S. Food and Drug Administration for any indication.

SCYNEXIS Reports Full Year 2019 Financial Results and Provides Company Update

On March 11, 2020 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 year ended December 31, 2019, and provided an update on recent clinical and corporate developments (Press release, Scynexis, MAR 11, 2020, View Source [SID1234555422]).

"The significant progress made in 2019 advanced us several steps closer to our goal of bringing ibrexafungerp to millions of patients worldwide who are in need of new options to overcome and prevent serious fungal infections. We are conducting multiple late-stage clinical studies of oral ibrexafungerp in indications ranging from vaginal yeast infections, for which there’s only one approved oral therapy, to the life-threatening Candida auris infections affecting patients in hospital settings with compromised immune systems," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "Ibrexafungerp represents a novel class of antifungals in a field in which no new class has been approved in nearly 20 years. We believe ibrexafungerp has the potential to become a leading antifungal therapy in both the community and hospital settings, particularly given the lack of innovation in the category, growing resistance to existing treatments, and evolution of new species that pose an urgent threat to the public."

Ibrexafungerp Development Update

Announced positive top-line results for the Phase 3 VANISH-303 study and completion of enrollment in the Phase 3 VANISH-306 study, investigating the safety and efficacy of oral ibrexafungerp as a treatment for women with vaginal yeast infections. In the VANISH-303 study, ibrexafungerp achieved superiority over placebo with high statistical significance (p≤0.001) for the key endpoints required to support the New Drug Application (NDA) filing for this indication. Both the VANISH-303 and VANISH-306 studies achieved faster-than-expected enrollment, demonstrating both the expected market opportunity and SCYNEXIS’s stated timeline to submit an NDA to the U.S. Food and Drug Administration (FDA) for the treatment of VVC in the second half of 2020.

Announced Special Protocol Assessment (SPA) agreement with FDA for Phase 3 CANDLE study, evaluating oral ibrexafungerp for the prevention of recurrent VVC, a condition with no FDA-approved therapies. Enrollment is ongoing in this study and SCYNEXIS anticipates top-line data and supplemental NDA submission in the second half of 2021. An open-label sub-study within CANDLE will also explore ibrexafungerp’s efficacy in patients who failed treatment with fluconazole.

Announced positive results from the second interim analysis of the ongoing Phase 3 open-label FURI study. The study is evaluating oral ibrexafungerp as a salvage treatment in patients with difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to or intolerant of current standards of care, or require a non-azole oral step-down therapy for treatment of azole-resistant Candida species. An independent Data Review Committee assessed the efficacy of oral ibrexafungerp in a second cohort of 21 treated patients from the FURI study. Together with the initial 20 patients reported in January 2019, the dataset consists of 41 patients analyzed to date. Efficacy was consistent across both interim analyses, as oral ibrexafungerp showed clinical benefits in 83% of patients (34 out 41), with 23 patients achieving a complete or partial response and 11 patients a stable disease response. Of the 41 treated patients, only six did not respond to ibrexafungerp treatment and one patient was considered indeterminate. The data will be presented at an upcoming scientific conference in the first half of 2020.

Amended the protocol for the ongoing Phase 3 open-label FURI study. Under the amended study design, the protocol was expanded to include patients with complex fungal infections such as aspergillosis, coccidioidomycosis, histoplasmosis, blastomycosis and infections caused by other emerging fungi including yeasts and molds in addition to Candida infections. Maximum allowed treatment duration with ibrexafungerp has been extended from 90 days to up to 180 days, as needed for chronic conditions. Ibrexafungerp will also be available as a combination therapy with standard of care (SoC) for certain infections.

Enrollment ongoing in Phase 3 open-label CARES study. Enrollment continues in the CARES study for patients with Candida auris infections. The Centers for Disease Control and Prevention (CDC) recently declared Candida auris, an emerging, multidrug-resistant pathogen, an "Urgent Threat" to public health.

Enrollment ongoing in Phase 2 SCYNERGIA study. Enrollment continues in the SCYNERGIA study for patients with invasive aspergillosis (IA) and SCYNEXIS recently amended the protocol to include transplanted patients, who are a well-known category at risk of fatal infection due to Aspergillus.

SCYNEXIS continues to explore development of IV formulation of ibrexafungerp. While oral ibrexafungerp is progressing as a potentially valuable option to treat hospital-based invasive fungal infections, as recently shown in the second interim analysis from the FURI study, SCYNEXIS is developing an intravenous liposomal formulation of ibrexafungerp and will provide further updates on this program in the future.

SCYNEXIS continues to educate the scientific community about the broad clinical utility of ibrexafungerp. SCYNEXIS attended 11 national and international scientific conferences with 30 oral and poster presentations. In 2019, a total of ten ibrexafungerp scientific publications were released.
Corporate Highlights

In December 2019, SCYNEXIS raised approximately $35 million in a public offering of common stock and warrants. SCYNEXIS sold 38,888,889 shares of its common stock and warrants to purchase up to 38,888,889 shares of SCYNEXIS’s common stock. Additionally, the underwriters exercised an option to purchase 5,833,333 additional warrants. Based upon SCYNEXIS’s existing operating plan, SCYNEXIS believes that its existing cash and cash equivalents and short-term investments, and the sale of a portion of SCYNEXIS’s NOLs, will enable it to fund operating requirements past a potential Prescription Drug User Fee Act (PDUFA) date in mid-2021 for the treatment of VVC when SCYNEXIS expects the FDA to complete the review of the NDA and potentially approve ibrexafungerp for the treatment of VVC.

In January 2020, SCYNEXIS entered into an agreement to sell a portion of its unused Net Operating Losses (NOLs) and R&D credits; SCYNEXIS expects to receive a cash receipt of approximately $3.1 million.

In December 2019, SCYNEXIS appointed Philippe Tinmouth to its Board of Directors. Mr. Tinmouth brings over 20 years of experience across multiple business development and alliance management roles.
Full Year 2019 Financial Results
Cash, cash equivalents and short-term investments totaled $48.4 million as of December 31, 2019, compared to $44.2 million in cash, cash equivalents, and short-term investments at December 31, 2018.

Research and development expenses for the year ended December 31, 2019 increased to $38.4 million from $21.6 million for the year ended December 31, 2018. The increase of $16.8 million, or 78.1%, was primarily driven by a milestone payment made in 2019 to Merck upon initiation of the Phase 3 VVC registration study, an increase of $11.8 million in clinical development expenses, an increase of $0.6 million in chemistry, manufacturing, and controls (CMC), and an increase of $1.1 million in salary and personnel related costs, and a net increase of $1.0 million in other research and development expenses, offset in part by a decrease of $1.7 million in preclinical expenses.

Selling, general and administrative expenses for the year ended December 31, 2019 increased to $10.6 million from $8.7 million for the year ended December 31, 2018. The increase of $2.0 million, or 22.7%, was primarily driven by a $1.0 million increase in business development and commercial related costs, a $0.6 million increase in professional fees, a $0.4 million increase in salary and personnel related costs, and a net increase in other selling, general and administrative expenses of $0.2 million, offset in part by a $0.2 million charge for deferred offering costs recognized in 2018.

Total other expense was $4.8 million for the year ended December 31, 2019, compared to total other income of $10.8 million for the year ended December 31, 2018. The $4.8 million in total other expense is primarily attributable to a $4.5 million non-cash loss and a $1.6 million non-cash gain recorded on the fair value adjustments of the warrant liabilities and derivative liability, respectively, for the year ended December 31, 2019.

Net loss for the year ended December 31, 2019 was $53.7 million, or ($0.96) per basic and diluted share, compared to a net loss of $12.5 million, or ($0.28) per basic and diluted share, for the year ended December 31, 2018.

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

Synlogic to Present at Chardan’s Virtual Microbiome Medicines Summit

On March 11, 2020 Synlogic (Nasdaq: SYBX) reported that Richard Riese, M.D., Ph.D., Synlogic’s chief medical officer, will present at the Chardan Microbiome Medicines Summit at Noon ET on Monday, March 16th, 2020 (Press release, Synlogic, MAR 11, 2020, View Source [SID1234555421]).

This is a virtual event. A live webcast of the presentation can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived copy of the webcast will be available on the Synlogic website for approximately 30 days after the event.