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Aeglea BioTherapeutics Reports Third Quarter 2020 Financial Results and Corporate Highlights

On November 5, 2020 Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare and other high-burden diseases, reported its third quarter 2020 financial results, and provided recent corporate and program highlights (Press release, Aeglea BioTherapeutics, NOV 5, 2020, View Source [SID1234570233]).

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"Although it’s been a challenging environment for biotech with the global pandemic, we have continued to be productive in our Arginase 1 Deficiency patient identification and engagement efforts. I am pleased with the progress we are making overall as well as specifically at our PEACE trial sites," said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. "I am also excited by the momentum we are building in our Homocystinuria program with the recent granting of U.S. Orphan Drug Designation and a positive opinion for EU Orphan Drug Designation for ACN00177."

Recent Highlights and Updates

Pegzilarginase in Arginase 1 Deficiency

In September, Aeglea announced the PEACE Phase 3 pivotal trial was more than 50% enrolled with nearly twice the number of patients needed to complete enrollment identified at active trial sites. Enrollment for the trial is anticipated to be completed in January 2021.
As of September, Aeglea has identified over 250 Arginase 1 Deficiency patients in addressable markets, a 25% increase relative to the prior year. The number of currently identified patients represents more than 50% and 30% of the estimated genetic prevalence populations in the U.S. and EU5, respectively.
ACN00177 in Homocystinuria

In October, Aeglea announced the U.S. Food and Drug Administration granted Orphan Drug Designation to ACN00177 for the treatment of Homocystinuria.
Additionally, the European Medicines Agency Committee for Orphan Medicinal Products issued a positive opinion recommending Orphan Drug Designation for ACN00177 for the treatment of Homocystinuria in the European Union.
Corporate

In October, the Company strengthened its financial position with proceeds from shares of common stock sold under its ATM program, resulting in gross proceeds of $25 million, extending its cash runway into 2023.
Upcoming Events

Aeglea will be attending the following virtual investor conferences in the fourth quarter:

Piper Sandler 32nd Annual Virtual Healthcare Conference, December 1-3
3rd Annual Evercore ISI HealthCONx Conference, December 1-3
Third Quarter 2020 Financial Results

As of September 30, 2020, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $141.5 million. In addition, in October 2020 the Company raised approximately $24.6 million in net proceeds from shares of common stock sold under its ATM program. Based on Aeglea’s current operating plan, and taking into account the net offering proceeds, management believes it has sufficient capital resources to fund anticipated operations into 2023.

Research and development expenses totaled $12.5 million for the third quarter of 2020 and $17.8 million for the third quarter of 2019. The decrease was primarily associated with completing certain manufacturing and pre-commercial activities for Aeglea’s lead product candidate, pegzilarginase, completing a Phase 1/2 clinical trial in patients with Arginase 1 Deficiency and closing cancer trials; offset by a ramp-up in manufacturing for ACN00177 in Homocystinuria and higher personnel-related expenses.

General and administrative expenses totaled $5.7 million for the third quarter of 2020 and $4.3 million for the third quarter of 2019. This increase was primarily due to ramping-up commercial capabilities and additional facilities to support company growth.

Net loss totaled $18.0 million and $21.6 million for the third quarter of 2020 and 2019, respectively, with non-cash stock compensation expense of $1.7 million and $1.4 million for the third quarter of 2020 and 2019, respectively.

About Pegzilarginase in Arginase 1 Deficiency

Pegzilarginase is an enhanced human arginase that enzymatically lowers levels of the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency (ARG1-D), a rare debilitating, progressive disease presenting in childhood with persistent hyperargininemia, spasticity, developmental delay, intellectual disability, seizures and early mortality. Pegzilarginase is intended for use as an enzyme therapy to reduce elevated blood arginine levels in patients with ARG1-D. Aeglea’s Phase 1/2 and Phase 2 open-label extension data for pegzilarginase in patients with ARG1-D demonstrated clinical improvements and sustained lowering of plasma arginine. The Company’s single, global pivotal Phase 3 PEACE trial is designed to assess the effects of treatment with pegzilarginase versus placebo over 24 weeks with a primary endpoint of plasma arginine reduction.

About ACN00177 in Homocystinuria

Aeglea is developing ACN00177 for the treatment of patients with cystathionine beta synthase (CBS) deficiency, also known as Classical Homocystinuria. Homocysteine accumulation plays a key role in multiple progressive and serious disease-related complications, including thromboembolic vascular events, skeletal abnormalities including severe osteoporosis, developmental delay, intellectual disability, lens dislocation and severe near-sightedness. ACN00177 has been designed as a novel recombinant human enzyme, which degrades the amino acid homocysteine and its related homocystine dimer. With this mechanism, ACN00177 is intended to lower the abnormally high blood levels of homocysteine in patients with Homocystinuria. Preclinical data demonstrated that ACN00177 improved important disease-related abnormalities and survival in a mouse model of Homocystinuria. The Company initiated a Phase 1/2 trial in the second quarter of 2020 and continues patient identification and administrative activities. The timing of first patient dosing in this Phase 1/2 trial will depend on determinations by individual sites as they adjust to impacts from COVID-19. ACN00177 has been granted Orphan Drug Designation by the U.S. FDA and received a positive opinion on Orphan Drug Designation from the European Medicines Agency.

Cellecta Introduces GeoMx Digital Spatial Profiling Service to Provide Novel Insights into Tumor Biology

On November 5, 2020 Cellecta, Inc. reported the launch of its new RNA Spatial Profiling Service using NanoString’s GeoMx Cancer Transcriptome Atlas (CTA) on the GeoMx Digital Spatial Profiler (Press release, Cellecta, NOV 5, 2020, View Source [SID1234570231]). As one of the few designated GeoMx Premier Access Site Partners worldwide, Cellecta offers immediate access to spatial transcriptomic analysis using the NanoString CTA and, upon release, to the GeoMx Whole Transcriptome Atlas.

Researchers are now able to send fresh-frozen or formalin-fixed paraffin-embedded (FFPE) tissue slides to Cellecta for gene expression profiling and spatial analysis to readily obtain comprehensive gene expression profiles of microenvironments and localized regions within tumors and related fixed tissues, as well as corresponding pathway analysis in a variety of visualization formats.

"With the increasing number of researchers interested in assessing the utility of spatial transcriptomics for their tumor samples, we are pleased to welcome Cellecta into our global service network as a GeoMx Premier Access Partner," said Chad Brown, senior vice president of sales and marketing at NanoString. "Their proven skills with RNA expression profiling and functional genomic analysis will be of great benefit to those seeking a greater understanding of tumor biology."

"We are honored to be counted among the handful of GeoMx Premier Access Partners chosen to offer this novel spatial analysis technology to cancer researchers in academia and industry," said Alex Chenchik, Ph.D., president and chief scientific officer of Cellecta. "Given our experience working with RNA throughout the years and especially with our DriverMap Targeted RNA-Seq technology, Digital Spatial Profiling is the logical next step in providing our customers with more comprehensive transcriptomic data to enable valuable research insights that advance the understanding of disease progression and drug development."

For more information Cellecta’s RNA Spatial Profiling Service, visit View Source

OncoSec Hosting an Investor and Analyst Day Webinar Showcasing Positive KEYNOTE-695 Data in Anti-PD-1 Checkpoint Refractory Metastatic Melanoma

On November 5, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported that it will host an Investor and Analyst webinar on Wednesday, November 11, 2020 from 8:30 am ET – 10:00 am ET showcasing interim data from its KEYNOTE-695 registration-enabled Phase 2b clinical trial investigating TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), in combination with KEYTRUDA (pembrolizumab) in patients with anti-PD-1 checkpoint refractory metastatic melanoma (Press release, OncoSec Medical, NOV 5, 2020, View Source [SID1234570230]).

Additional topics will include an update on its KEYNOTE-890 Phase 2 clinical trial investigating TAVO in patients with metastatic triple negative breast cancer (mTNBC) as well as a discussion on CORVax12, the Company’s novel DNA-encodable vaccine for COVID-19. CORVax12 combines TAVO with the National Institute of Health’s DNA-encodable stabilized trimeric SARS-CoV-2 spike glycoprotein and is expected to enter a Phase 1 clinical trial in the immediate future given recent IND acceptance.

Experts will also share insights about OncoSec’s new neoadjuvant melanoma clinical trial and opinions on the visceral lesion applicator program, which will look to the future of gene electrotransfer in both lung and liver tumors. A live question and answer session will follow the formal presentations.

This webcast is intended for institutional investors, sell-side analysts, and business development professionals.

To register for the investor and analyst day, please click here. For those who cannot participate, the event will be recorded and available on the company website.

The event will feature presentations by the following Key Opinion Leaders (KOLs):

Tara Mitchell, MD, Associate Professor of Medicine, will describe the challenges of treating patients with checkpoint refractory metastatic melanoma. Dr. Mitchell will also give her initial review of the KEYNOTE-695 data.
Alain Algazi, MD, Associate Professor, Department of Medicine and Adil Daud, MD, Professor of Clinical Medicine, UCSF Helen Diller Family Comprehensive Cancer Center, will present and evaluate the KEYNOTE-695 clinical data and how it compares to other current treatments.
Matteo Carlino, MD, Medical Oncologist and Clinical Senior Lecturer, Westmead and Blacktown Hospitals and University of Sydney, will provide his interpretation of the KEYNOTE-695 data and comment on how it will impact the way he treats patients.
Ahmad Tarhini, MD, PhD, Director, Cutaneous Clinical and Translational Research, Moffitt Cancer Center, will provide an update on the ongoing neoadjuvant study combining TAVO and OPDIVO.
Bernard Fox, PhD, Harder Family Chair for Cancer Research, Member and Chief of the Laboratory of Molecular and Tumor Immunology, Earle A. Chiles Research Institute, will provide an overview of the trial design for CORVax12, a COVID-19 vaccine. He will also comment on the strategy behind this vaccine.
Rohit Joshi, MBBS, MD, FRACP, FACP, Medical Oncologist, Adelaide Medical School and Calvary Central Districts Hospital, will provide an overview of the KEYNOTE-890 study in triple negative breast cancer (TNBC).
Dan Simon, MD, Interventional Radiologist Chief, Maryland Cardiology Associates, will provide an overview of the Visceral Lesion Applicator program. He will share his experience with the technology and provide insight as to what this means for the future of gene electrotransfer.
About KEYNOTE-695

KEYNOTE-695 is OncoSec’s registration-directed Phase 2b trial (NCT#03132675) evaluating TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12) + KEYTRUDA (pembrolizumab) in patients with rigorously confirmed anti-PD-1 checkpoint resistant metastatic melanoma. The trial aims to enroll up to 100 patients with refractory, locally advanced or metastatic disease defined as unresectable Stage III/IV metastatic melanoma that had definitively progressed on a full-course of anti-PD-1 treatment with KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab). TAVO has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of metastatic melanoma following progression on KEYTRUDA or OPDIVO.

About TAVO

OncoSec’s gene therapy technology combines TAVOTM (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-895 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration (FDA) for the treatment of metastatic melanoma following progression on KEYTRUDA or OPDIVO.

About Advanced Metastatic Melanoma

Metastatic melanoma refers to stage IV melanoma, which has typically spread through the lymph nodes to distant sites in the body such as the liver, lungs, bones and brain. Every year, approximately 100,000 adults in the United States are diagnosed with metastatic melanoma. Due to this metastatic tumor burden, stage IV melanoma is often very difficult to treat. Available treatment options frequently combine surgery with immunotherapy or targeted therapy. The 5-year survival rate for metastatic melanoma is approximately 25%.

About Metastatic Triple Negative Breast Cancer (TNBC)

Metastatic triple negative breast cancer (mTNBC) is an aggressive type of breast cancer with a high recurrence rate within the first five years following diagnosis, which accounts for 10-20% of all breast cancers. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is difficult to treat and there are very few FDA approved treatment options for these patients, which mostly rely on surgery, radiation, and chemotherapy. The 5-year survival rate for these patients is approximately 11%.

About CORVax12

CORVax12 is the only DNA vaccine that uses an immune stimulant to promote an immune response against the SARS-CoV-2 virus. The CORVax12 vaccine approach combines the co-administration of TAVO (plasmid IL-12) with a DNA-encodable version of the SARS-CoV-2 spike or "S" glycoprotein to enhance immunogenicity of the component developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. CORVax12 is designed to drive a coordinated vaccine response, capable of drawing upon the innate and adaptive humoral and cellular arms. This multi-pronged innate, adaptive and cellular immune response has the potential to generate a robust anti-viral response.

Bioniz Announces Oral Presentation at ASH 2020 of Positive Clinical Data of BNZ-1 for the Treatment of Refractory Cutaneous T-Cell Lymphoma

On November 5, 2020 Bioniz Therapeutics, Inc. ("Bioniz") reported an oral presentation at the 62nd ASH (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2020) of positive safety and efficacy data from the company’s Phase 1/2 clinical study of BNZ-1 for the treatment of refractory cutaneous T-cell lymphoma (rCTCL), a rare, aggressive cancer (Press release, Bioniz Therapeutics, NOV 5, 2020, View Source [SID1234570229]). These clinical data are the first to demonstrate therapeutic efficacy of BNZ-1, a multi-cytokine inhibitor selectively targeting three interleukins, IL-2, IL-9, and IL-15. In the study, BNZ-1 treatment was well tolerated with no dose-limiting toxicities or drug-related serious side effects. BNZ-1 is the lead asset from the company’s platform of first-in-class peptide therapeutics that selectively and simultaneously inhibit multiple cytokines to treat cancer and autoimmune diseases.

About the oral presentation at ASH (Free ASH Whitepaper) 2020:
Title: Co-inhibition of IL-2, IL-9 and IL-15 by the novel immunomodulator, BNZ-1, provides clinical efficacy in patients with refractory cutaneous T cell lymphoma in a phase 1/2 clinical trial
Session Number and Name: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Clinical Studies in T/NK Cell Lymphoma
Presenter: Christiane Querfeld, M.D., Director of the Cutaneous Lymphoma Program at the City of Hope, and principal investigator of the study
Session Date and Time: Saturday, December 5 at 7:30 am to 9:00 am PST

"These are the first data to demonstrate efficacy of BNZ-1, a multi-cytokine inhibitor, in treating cancer, and further validate our therapeutic platform and our pipeline of anti-cytokine therapies for the treatment of cancer and autoimmune diseases," said Dr. Nazli Azimi, Founder and CEO of Bioniz Therapeutics and co-inventor of BNZ-1. "We believe that the multi-cytokine targeting of BNZ-1 delivers a multimodal immunomodulation effect to decrease the proliferation of malignant cells, control the inflammation generated by the cancer in the tumor microenvironment, and lower the inhibitory activity of regulatory T-cells."

The Phase 1/2 clinical study was designed as a multi-center, open-label, dose-escalation study of BNZ-1 to assess its safety and efficacy as a single systemic agent in rCTCL patients that have failed standard of care and other available treatment options. The primary endpoint of the study was overall safety after four weeks of treatment. There was a three-month treatment extension to further evaluate safety and clinical response. Long Term Extension (LTE) was available for patients who benefited from BNZ-1 treatment. In the dose ranging part of the study, 15 patients (stages IB and IVB) were enrolled across the four dose cohorts (0.5, 1, 2, and 4 mg/kg) for intravenous weekly dosing. BNZ-1 showed activity in all doses as it was determined by early signs of clinical efficacy and pharmacodynamic (PD) biomarkers.

The 2 mg/kg dose was selected based on PK/PD relationship and clinical efficacy and expanded to a total of 19 patients. Clinical efficacy was measured by mSWAT and GRS as defined previously (Olsen E. et al. 2011). The results of the efficacy study of 19 patients are as follows:

Based on the best response (GRS) one patient (5%) achieved a complete response, and eleven (58%) patients achieved a partial response by the end of the study (ORR 63.2%) that includes the LTE.
Seven patients (37%) showed stable disease during study period. No disease recurrence was observed during the study period.
"Currently, rCTCL patients switch treatments every four months due to side effects, so we are extremely encouraged that BNZ-1 treatment was well tolerated, which could support long-term treatment for these patients," concluded Dr. Azimi.

About Refractory Cutaneous T-cell lymphoma (rCTCL)
Cutaneous T-cell lymphoma (CTCL) is a heterogeneous group of non-Hodgkin’s lymphomas that manifest primarily in the skin. Although a wide array of therapeutic options are available for early-stage CTCL, not all patients respond, resulting in refractory CTCL (rCTCL) with limited treatment options and a poor prognosis.

About BNZ-1
The company’s lead product candidate, BNZ-1, is a selective inhibitor of cytokines IL-2, IL-9, and IL-15, which are potent T-cell growth factors and key disease drivers in CTCL. Bioniz is also evaluating BNZ-1 for the treatment of autoimmune diseases, including alopecia areata and vitiligo, which are also driven by unregulated T-cell biology.

Immunic, Inc. Reports Third Quarter 2020 Financial Results and Provides Corporate Update

On November 5, 2020 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, reported financial results for the third quarter ended September 30, 2020 and provides corporate update (Press release, Immunic, NOV 5, 2020, View Source [SID1234570227]).

"The third quarter was marked by a significant achievement for our lead asset, selective oral DHODH inhibitor, IMU-838, with the release of top-line data from our phase 2 EMPhASIS trial in patients with relapsing-remitting multiple sclerosis, and subsequent publication of the full unblinded data set. IMU-838 demonstrated robust efficacy, through the achievement of all primary and key secondary endpoints, combined with an outstanding safety and tolerability profile. We believe that the phase 2 results emphasize the game-changing potential of IMU-838 as a once-daily oral therapy for this indication," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "On the heels of this overwhelmingly positive data, we completed a successful common stock offering, raising $103.5 million in gross proceeds, significantly bolstering our balance sheet. We are currently preparing our end-of-phase 2 submission for IMU-838 in relapsing-remitting multiple sclerosis to regulatory authorities, anticipated in the first quarter of next year, after which we look forward to scheduling our end-of-phase 2 meetings, during which we will have the opportunity to discuss our plans for a phase 3 program."

Dr. Vitt continued, "We have also made notable strides in our development of IMU-838 in patients with moderate COVID-19, most recently securing a financing agreement of up to €24.5 million (approximately $29 million) with the European Investment Bank for the ongoing development of our phase 2 CALVID-1 trial, a potential expansion into a confirmatory phase 3 trial and commercial-scale manufacturing of IMU-838. Additionally, we reported that an Independent Data Monitoring Committee recommended the continuation, without changes, of the CALVID-1 trial after an interim safety analysis. Recruitment has accelerated due to the spread of disease within the countries included in the trial and, at the beginning of November, we reached the enrollment goal of 200 patients, pre-specified in the protocol as sufficient to perform the main efficacy analysis of the phase 2 part of the CALVID-1 trial. The data of this unblinded main analysis of all available efficacy, biomarker and virus titer data is expected to be available in the first quarter of next year."

The company’s current cash position of approximately $133.2 million, at September 30, 2020, is expected to fund activities into the second half of 2022, and specifically through key value inflection points including those for the COVID-19 phase 2 trial with IMU-838; preparation for, and initiation of, a phase 3 trial of IMU-838 in relapsing-remitting multiple sclerosis (RRMS); the phase 2 readouts of IMU-838 in patients with ulcerative colitis (UC) and primary sclerosing cholangitis (PSC); as well as completion of the phase 1 trials of IMU-935 and IMU-856, respectively, including pharmacodynamic evaluations in patients for both of these trials.

Third Quarter 2020 and Subsequent Highlights

November 2020: Announced 200 patients enrolled and randomized in phase 2 CALVID-1 trial of IMU-838 for the treatment of moderate COVID-19, allowing for main phase 2 efficacy analysis to proceed.
October 2020: Signed financing agreement with the European Investment Bank for up to €24.5 million (approximately $29 million) to support the development of IMU-838 in patients with moderate COVID-19.
September 2020: Announced results of interim safety analysis from ongoing phase 2 CALVID-1 trial of IMU-838 in patients with moderate COVID-19. Independent Data Monitoring Committee recommended continuation of the trial without changes.
September 2020: Published full unblinded clinical data set from phase 2 EMPhASIS trial of IMU-838 in patients with RRMS and announced poster presentation at the MSVirtual2020/8th Joint ACTRIMS-ECTRIMS Meeting. Data confirmed and expanded on the previously announced top-line results, which showed achievement of all primary and secondary endpoints.
August 2020: Dosed first healthy volunteer in phase 1 clinical program of IMU-856, targeting restoration of intestinal barrier function.
August 2020: Completed a $103.5 million public offering of 5,750,000 shares of common stock, including the full exercise of underwriters’ option to purchase an additional 750,000 shares.
August 2020: Announced positive top-line data from phase 2 EMPhASIS trial of IMU-838 in patients with RRMS. Study met all primary and key secondary endpoints, indicating activity in RRMS patients.
July 2020: Enrolled first patients in investigator-sponsored phase 2 IONIC trial of IMU-838 in combination with Oseltamivir (Tamiflu), in collaboration with sponsor and lead site, University Hospitals Coventry and Warwickshire (UHCW) NHS Trust.
Update on Activities Relating to the Preparation of a Phase 3 Program for IMU-838 in RRMS

As previously announced, the full unblinded clinical data set from the company’s phase 2 trial of IMU-838 in patients with RRMS showed achievement of all primary and key secondary endpoints, with high statistical significance. Notably, both doses (30 and 45 mg/day) appeared to be equally safe and efficacious, reducing the number of combined unique active (CUA) magnetic resonance imaging (MRI) lesions up to week 24, as compared to placebo. Based on this phase 2 data as well as established regulatory guidance that the lowest effective dose should be considered for future clinical trials, Immunic may propose the dose of 30 mg/day of IMU-838 for investigation in a phase 3 program.

Given the relative equal performance of the two doses tested, however, and to allow for pharmacodynamic modeling of the dose-response relationship, data from a lower dose in the effective dose range would be beneficial to complete a dose-effect assessment of IMU-838 in RRMS. For this reason, Immunic has already started an additional, small Cohort 2 sub-trial to obtain exploratory data on the expanded dose response of IMU-838. This additional, double-blind assessment includes a cohort of 60 patients who receive 10 mg/day of IMU-838 or placebo for 24 weeks. The still-active sites of the phase 2 trial of IMU-838 in RRMS continue to be used and, as a result, the company expects that this assessment can be executed in an accelerated fashion. This additional sub-trial is not expected to change any conclusions for dosing of IMU-838 in a future phase 3 program. Rather, it is expected to provide additional data to address any potential regulatory requests in the context of the design of a phase 3 program. Management believes that this strategy will enable risk reduction for end-of-phase 2 discussions with regulatory agencies.

The company intends to separate formal end-of-phase 2 meeting preparations from regulatory advice for non-clinical phase 3 related topics to be submitted to regulatory authorities in the near future. Subsequently, the company intends to submit formal end-of-phase 2 meeting requests with a sole focus on the phase 2 data, including the Cohort 2 interim data, and a proposed phase 3 program to regulatory authorities at the end of the first quarter 2021. The end-of-phase 2 meetings are expected to be held in or about May 2021.

In parallel to the preparation and execution of the regulatory discussions, Immunic has begun performing formal feasibility activities for a phase 3 program of IMU-838 in RRMS, including country and site selection, as well as other preparatory activities. The company also believes that this feasibility assessment will help ensure an expeditious execution of the development strategy for IMU-838.

Additional Anticipated Clinical Milestones

IMU-838 in PSC: Due to the COVID-19 pandemic, recruitment for the phase 2, investigator-sponsored proof-of-concept clinical trial for IMU-838 in PSC, being conducted at the Mayo Clinic, is currently paused as patients with PSC are considered high risk for COVID-19 infections and were advised by the investigators to avoid travelling to the clinical sites. Together with the investigators, Immunic currently expects a potential data readout during the fourth quarter of 2020 using the 18 patients who were enrolled prior to the COVID-19 pandemic. The overall recruitment target for this open-label study is 30 patients.
IMU-838 in COVID-19: Top-line efficacy, biomarker and virus titer data from the phase 2 CALVID-1 trial of IMU-838 in patients with moderate COVID-19, based on approximately 200 patients treated, is expected to be available in the first quarter of 2021, after which the company will be able to evaluate whether the program may be expanded into a confirmatory phase 3 trial.
IMU-838 in UC: Although the recruitment of the phase 2 clinical trial of IMU-838 for the treatment of UC has continued during the COVID-19 pandemic, the pandemic has affected, among other things, access to endoscopy sites or hospitals in some countries, which has interfered with recruitment speed, new site activations and clinical site access. As a result, top-line data is now expected to be available in the first half of 2022, instead of in the fourth quarter of 2021 as previously announced.
IMU-935 phase 1 program: The current, single ascending dose part of the ongoing phase 1 trial of IMU-935 is planned to be followed by a multiple ascending dose portion in healthy volunteers and a safety evaluation in patients with mild-to-moderate psoriasis. The trial has been resumed after a temporary pause of trials in healthy volunteers imposed by ethics committees in Australia due to COVID-19. Unblinded safety data from the single and multiple ascending dose parts in healthy volunteers is expected to be available in the first half of 2021. Initiation of the third portion in patients with mild-to-moderate psoriasis is expected in the first half of 2021 and is expected to last approximately 12 months.
Potential IMU-935 phase 2 trial in an orphan autoimmune disorder: Upon completion of the single and multiple ascending dose portions of the ongoing phase 1 trial, Immunic anticipates that it may also begin a phase 2 proof-of-concept clinical trial of IMU-935 in an orphan autoimmune indication. This orphan approach may allow for an accelerated path to approval, in parallel to IMU-935’s previously planned development in psoriasis. After a thorough review of suitable autoimmune conditions, the company has targeted IMU-935 for further development in Guillain-Barré syndrome, an acute neurological disorder in which the body’s immune system attacks its peripheral nervous system, and for which very few therapies exist. The company plans to announce additional details as soon as design and timing of the envisaged trial are defined.
Financial and Operating Results

Research and Development (R&D) Expenses were $11.0 million for the three months ended September 30, 2020, as compared to $7.1 million for the same period ended September 30, 2019. The $3.9 million increase was primarily attributable to (i) a $2.9 million increase in external development costs for IMU-838, related to the phase 2 clinical trial in patients with COVID-19, (ii) a $2.2 million increase in license fees, drug supply and phase 1 costs related to IMU-856, (iii) a $0.6 million increase in development costs for the IMU-935 program, and (iv) a $0.5 million increase in personnel costs. The increases were partially offset by a decrease of $2.3 million in costs related to the phase 2 clinical trial of IMU-838 in patients with RRMS.
For the nine months ended September 30, 2020, R&D expenses were $27.5 million, as compared to $16.5 million for the same period ended September 30, 2019. The $11.0 million increase was primarily attributable to (i) a $4.8 million increase in external development costs for IMU-838, related to the phase 2 clinical trial in patients with COVID-19, (ii) a $4.5 million increase in license fees, drug supply and phase 1 costs related to IMU-856, (iii) a $1.4 million increase in drug supply costs related to IMU-935, (iv) a $1.2 million increase in drug supply costs related to IMU-838, and (v) a $0.6 million increase in personnel costs. The increases were partially offset by a decrease of $1.5 million related to the phase 2 clinical trial of IMU-838 in patients with RRMS.
General and Administrative (G&A) Expenses were $2.5 million for the three months ended September 30, 2020, as compared to $2.1 million for the same period ended September 30, 2019. The $0.4 million increase was primarily due to increased personnel expenses.
For the nine months ended September 30, 2020, G&A expenses were $7.3 million, as compared to $12.4 million for the same period ended September 30, 2019. The $5.0 million decrease was primarily due to (i) non-recurring costs related to the transaction with Vital Therapies including $6.4 million of stock-based compensation for company executives, key employees and members of the board of directors, and (ii) $2.1 million of non-recurring investment banking and legal fees in the first nine months of 2019. The decrease was partially offset by (i) a $2.3 million increase in personnel expenses, (ii) $1.0 million of increased legal, accounting and consultancy costs, and (iii) $0.2 million of increased costs across numerous categories primarily due to becoming a public company and expanding operations in the United States.
Other Income was $0.6 million for the three months ended September 30, 2020, as compared to $0.9 million for the same period ended September 30, 2019. The $0.3 million decrease was primarily attributable to the $0.4 million difference between the face value and fair value of the promissory note collected in full in September 2019 in connection with the sale of certain assets of Vital Therapies (ELAD Assets), partially offset by the $0.1 million write-off of the investment in Vital Therapies (Beijing) Company Limited (VTL China) included in the ELAD Assets sale.
For the nine months ended September 30, 2020, other income was $1.9 million, as compared to $1.6 million for the same period ended September 30, 2019. The $0.3 million increase was primarily attributable to $0.7 million of R&D tax incentives for clinical trials in Australia as a result of increased spending on clinical trials in Australia, partially offset by a decrease attributable to (i) the $0.4 million difference between the face value and fair value of the promissory note collected in full in September 2019 in connection with the sale of ELAD Assets offset by the $0.1 million write-off of the investment in VTL China included in the ELAD Assets sale, and (ii) a $0.1 million decrease of recognized income attributable to reimbursements of R&D expenses in connection with the option agreement with Daiichi Sankyo Co., Ltd.
Net Loss for the three months ended September 30, 2020 was approximately $12.9 million, or $0.70 per basic and diluted share, based on 18,405,840 weighted average common shares outstanding, compared to a net loss of approximately $8.2 million, or $0.82 per basic and diluted share, based on 10,022,856 weighted average common shares outstanding for the same period ended September 30, 2019.
Net loss for the nine months ended September 30, 2020 was approximately $32.9 million, or $2.35 per basic and diluted share, based on 13,966,690 weighted average common shares outstanding, compared to a net loss of approximately $27.2 million, or $3.96 per basic and dilutes share, based on 6,880,057 weighted average common shares outstanding for the same period ended September 30, 2019.
Cash and Cash Equivalents, as of September 30, 2020, were $133.2 million, which management expects to be sufficient to fund operations into the second half of 2022.