On July 16, 2020 Zikani Therapeutics, a company leveraging its unique TURBO-ZMTM platform to develop novel ribosome modulating agents (RMAs) for the treatment of rare, nonsense mutation-driven diseases, reported the appointment of Vijay Modur, M.D., Ph.D., as its Chief Scientific and Medical Officer to lead the company in advancing its ribosome-modulating scientific platform into the next stage of drug development (Press release, Zikani Therapeutics, JUL 16, 2020, View Source [SID1234561985]).

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Dr. Modur was previously Global Project Head in Rare Disease Clinical Development at Sanofi-Genzyme where he oversaw key functions responsible for advancing venglustat for the treatment of conditions caused by lysosomal dysfunction and other investigational therapies for several rare diseases, many with the potential for accelerated approval. Before joining Sanofi-Genzyme, Dr. Modur served as Chief Medical Officer and Vice President of Translational Research for HTG Molecular. Dr. Modur previously held clinical development leadership roles at Novartis and Merck.

"Zikani’s top priority is to advance its current nonsense mutation readthrough programs from lead optimization to candidate selection for first in human clinical trials following the positive, pre-clinical data demonstrated in multiple disease areas," said Sumit Aggarwal, President and CEO, Zikani Therapeutics. "We’re optimistic about the opportunity to impact diseases with limited or no treatment options including: APC mutant colon cancer, familial adenomatous polyposis (FAP), class 1 cystic fibrosis, and recessive dystrophic and junctional epidermolysis bullosa (RDEB and JEB), and Vijay’s experience and leadership will strengthen our capabilities to pursue this important work," added Aggarwal.

"Zikani has focused its technology on where it holds the most promise and with the addition of Vijay is building a leadership team that will advance the company into the next phases of preclinical and clinical development," said Alan Walts, Ph.D., Executive Chairman of Zikani’s Board of Directors.

Dr. Modur earned his MBBS at Karnatak University, Dharwad, India and his Ph.D. in Experimental Pathology at the University of Utah. He completed his residency at Washington University, St. Louis where he served as Chief Resident, Laboratory Medicine. Dr. Modur is board certified in Clinical Pathology.

"The promise of impacting rare diseases through such novel technology that builds upon the science of modulating protein translation is compelling," said Modur. "The TURBO-ZMTM technology platform and the proof of cellular concept demonstrated across multiple disease states provides a compelling approach to treating rare diseases. I’m excited to join the team and look forward to making an impact on behalf of patients," added Modur.

Ribosomal RNAs form the translation machinery that generates function proteins from genetic sequences. Ribosome modulation provides a therapeutic approach to addressing a number of diseases, but the development of disease-specific ribosome modulators has been a challenge.

On July 16, 2020 Oncorus, Inc., a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported a clinical trial collaboration agreement with Merck (NYSE:MRK), known as MSD outside of the United States and Canada, through a subsidiary to evaluate the combination of Oncorus’ ONCR-177 with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as part of an ongoing Phase 1 study of ONCR-177 in adult patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors (Press release, Oncorus, JUL 16, 2020, View Source [SID1234561984]). ONCR-177, Oncorus’ lead product candidate, is an intratumorally administered oncolytic Herpes Simplex Virus (oHSV) viral immunotherapy being developed for the treatment of multiple solid tumor indications.

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"We are pleased to enter into this clinical collaboration with Merck, as we believe the mechanisms of ONCR-177 and KEYTRUDA are highly complementary," said Theodore (Ted) A. Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, to activate T cells, while ONCR-177 is designed to elicit an immunogenic cell death and stimulate T cells and additional key cells within both the innate and adaptive immune systems to drive a lasting and systemic anti-tumor response. Combining these two approaches has the potential to enhance antitumor immunity, and form immunologic memory against tumors. It also may help more patients become responders to immunotherapy."

As announced today by Oncorus, the Phase 1 study underway is an open-label, multi-center, dose escalation and expansion trial designed to evaluate the safety and tolerability and to determine the recommended Phase 2 dose as well as preliminary anti-tumor activity of ONCR-177 alone and in combination with KEYTRUDA.

Upon determination of the recommended Phase 2 dose, the study will then enroll patients to histology- specific expansion cohorts to demonstrate safety and initial efficacy of ONCR-177 as a monotherapy and in combination with KEYTRUDA, in addition to enabling biomarker exploration. The expansion cohorts will enroll patients with solid tumors who are refractory to, ineligible for, relapsed from and/or intolerant of standard of care treatment or have a disease for which no standard of care exists, including patients with breast cancer, squamous cell carcinoma of the head and neck (SCCHN), and melanoma.

For more information on the study, please visit: View Source

About ONCR-177

Oncorus has designed its proprietary oHSV Platform to develop improved intratumorally administered viral immunotherapies that have enhanced potency without sacrificing safety, a challenge that has been encountered by earlier generation programs in this class. ONCR-177 is designed to mount a powerful, multidimensional attack on cancer; it induces immunogenic cancer cell death and ignites innate and adaptive immunity to drive a lasting and systemic anti-tumor response. In addition to its oncolytic activity, ONCR-177 is armed with five immunomodulatory transgenes: IL-12, CCL4, FLT3LG, and antagonists of clinically proven immune checkpoints PD-1 and CTLA-4. This represents a greater payload capacity than viral immunotherapies that are either currently approved or in clinical development.

In preclinical studies, ONCR-177 was shown to stimulate multiples arms of the immune system, drive abscopal activity and prolong survival while limiting systemic exposure to transgene products, such as IL-12, that cannot be safely dosed systemically due to toxicities.

ONCR-177 retains full replication competency to enable potent tumor cell killing. It also incorporates two highly innovative approaches — the use of microRNA target sequences and a proprietary mutation engineered in an HSV-1 protein, known as UL37 — to allow for tumor-specific replication, which restricts viral activity to tumor cells while sparing normal tissues.

On July 16, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the fourth quarter of fiscal year 2020, which ended May 31, 2020 (Press release, AngioDynamics, JUL 16, 2020, View Source [SID1234561983]).

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"Our fourth quarter sales were impacted by the deferral of elective procedures associated with COVID-19, and we adjusted accordingly throughout the quarter to minimize the impact of the global pandemic on our business," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "Despite these temporary challenges, the underlying long-term fundamentals of our business remain intact, and we intend to continue investing strategically in our key growth platforms like Auryon, NanoKnife, and AngioVac. The steps that we took to manage the business through the end of the year will enable us to resume growth and improve our profitability as the environment eventually normalizes. While much of our near-term attention has been on managing through the impacts of COVID-19, we remain focused on our long-term strategy and the transformation of AngioDynamics into a Company with differentiated technology platforms that compete in larger, higher-growth addressable markets."

Fourth Quarter 2020 Financial Results

Net sales for the fourth quarter of fiscal 2020 were $58.3 million, a decrease of 18.1% compared to the prior-year quarter. Excluding the impact of Asclera sales, which were discontinued during fiscal year 2019, net sales decreased 16.8% year over year. Net sales were impacted across the board by the disruption to procedure volumes resulting from the COVID-19 global pandemic. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $12.5 million, a decrease of 18.0% from $15.3 million a year ago, with growth in NanoKnife capital sales more than offset by declines across the rest of the Oncology portfolio.
Vascular Interventions and Therapies ("VIT") net sales were $22.1 million, a decrease of 28.8%, compared to $31.0 million a year ago. Excluding last year’s Asclera sales of $1.1 million in the fourth quarter, VIT declined 26.2%.
Vascular Access net sales were $23.7 million, a decrease of 4.6% from $24.9 million a year ago.
Excluding Asclera, U.S. net sales in the fourth quarter of fiscal 2020 were $44.6 million, a decrease of 18.4% from $54.7 million a year ago, and International net sales were $13.7 million, a decrease of 10.9% from $15.4 million a year ago.

Gross margin for the fourth quarter of fiscal 2020 was 51.8%, a decline of 630 basis points compared to the fourth quarter of fiscal 2019. The gross margin decline was primarily attributable to under absorption in manufacturing operations, as the Company maintained staffing levels and continued producing product in the plant to provide flexibility during the severe uncertainty brought about by the COVID-19 global pandemic during the fourth quarter. The Company expects this under absorption to continue through the first half of fiscal 2021 as it continues to assess the shape and timing of the COVID-19 recovery. In addition, gross margin during the fourth quarter was negatively impacted by 160 basis points due to a write off of raw materials and existing dosimetry inventory associated with OARtrac that was purchased pursuant to the Company’s acquisition of RadiaDyne. These inventory items were deemed unmarketable absent subsequent design and development activities. This inventory write down has been excluded from the Company’s adjusted earnings per share and adjusted EBITDA.

The Company recorded a net loss from continuing operations of $156.1 million, or loss per share of $4.10, in the fourth quarter of fiscal 2020. This compares to net income from continuing operations of approximately $2.8 million, or earnings per share of $0.07, a year ago. Net income from continuing operations and GAAP earnings per share were negatively impacted by a goodwill impairment described in more detail below. Excluding this impairment, net income from operations and earnings per share in the fourth quarter of fiscal 2020 would have been $1.5 million and $0.04, respectively.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net loss for the fourth quarter of fiscal 2020 was $2.1 million, or a loss of $0.06 per share, compared to adjusted net income of $2.8 million, or earnings per share of $0.07, in the fourth quarter of fiscal 2019.

Adjusted EBITDA in the fourth quarter of fiscal 2020, excluding the items shown in the reconciliation table below, was $0.6 million, compared to $8.5 million in the fourth quarter of fiscal 2019.

In the fourth quarter of fiscal 2020, the Company generated $3.9 million in operating cash and had capital expenditures of $1.5 million. As of May 31, 2020, the Company had $54.4 million in cash and cash equivalents compared to $52.2 million in cash and cash equivalents at the end of the third quarter. This ending balance accounts for $27.2 million in cash and equivalents on February 29, 2020 plus the subsequent $25.0 million draw on the Company’s revolver. As of May 31, 2020, the Company had $40.0 million in debt outstanding, compared to $15.0 million in debt outstanding on February 29, 2020. Management remains focused on cash preservation amid the current environment.

Full-Year 2020 Financial Results

For the twelve months ended May 31, 2020:

Net sales were $264.2 million, a decrease of 2.4%, compared to $270.6 million for the same period a year ago. Excluding the impact of Asclera, sales of which were discontinued during fiscal year 2019, net sales were flat year over year.
The Company’s net loss from continuing operations was $165.8 million, or a loss of $4.37 per share, compared to a net loss from continuing operations of $11.1 million, or a loss per share of $0.30 per share, a year ago. Net loss from continuing operations and GAAP loss per share were negatively impacted by the goodwill impairment described in more detail below. In addition to the goodwill impairment, the net loss is largely attributable to the decline in the volume of elective surgeries as well as ongoing investment in key technology platforms such as Auryon, NanoKnife, and AngioVac. Excluding this impairment, net loss from operations and loss per share in fiscal 2020 would have been $8.2 million and $0.22, respectively.
Gross margin declined 70 basis points to 56.9% from 57.6% a year ago. In addition, gross margin during fiscal year 2020 was negatively impacted by 40 basis points due to the write off of raw materials described above.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $3.5 million, or $0.09 per share, compared to adjusted net income of $8.2 million, or $0.22 per share, a year ago.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $18.0 million, compared to $30.6 million for the same period a year ago.
Goodwill Impairment

As noted above, the Company recorded a goodwill impairment for the quarter and fiscal year ended May 31, 2020. At May 31, 2020, the Company identified a triggering event resulting from the Company’s market capitalization being below its book value of equity for a sustained period of time. Following the triggering event at May 31, 2020, the Company determined its fair value using a combination of the income approach and market approach. This valuation assessment indicated that the Company’s book value exceeded its fair value, resulting in an impairment of goodwill of $157.6 million. The continuing uncertainty created by the COVID-19 global pandemic and associated lower procedural volumes negatively impacted the Company’s fair value.

Fiscal Year 2021 Financial Guidance

The Company saw signs of a recovery throughout the fourth quarter of fiscal 2020; however, given the current trajectory of COVID-19 cases and the uncertainty surrounding the magnitude and duration of the continuing impacts of the pandemic, management will not be providing financial guidance for fiscal 2021 at this point in time.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2020 fourth quarter and full-year results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13705722.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, July 16, 2020, until 11:59 p.m. ET on Thursday, July 23, 2020. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13705722.

On July 16, 2020 Biodesix, Inc., a leader in lung cancer diagnostics, reported the publication of research findings on a diagnostic test capable of generating valuable data to help guide the treatment of patients with advanced non-small cell lung cancer (NSCLC) (Press release, Biodesix, JUL 16, 2020, View Source [SID1234561982]). The paper, entitled "A serum protein classifier identifying patients with advanced non-small cell lung cancer who derive clinical benefit from treatment with immune checkpoint inhibitors," concludes that a proteomic based diagnostic test can provide clinically significant information to predict outcomes of immune checkpoint inhibitor therapy and guide treatment choices made by physicians for patients with advanced NSCLC.

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"Publication of this data is an important milestone for Biodesix, and the findings from this study are a direct reflection of our identity and purpose," said Scott Hutton, CEO of Biodesix. "We are committed to advancing precision medical care to a level that reduces unnecessary treatment and health care costs, and that focuses on identifying and guiding the best treatment plan for every patient."

In the retrospective study, mass spectrometry-based proteomic analysis was performed on pretreatment sera derived from advanced NSCLC patients who were treated with nivolumab as part of routine clinical care. The 289 enrolled patients were stratified into three groups after receiving second-line treatment: good (sensitive), intermediate and poor (resistant). Pooled analysis demonstrated significantly better overall survival rates for "sensitive" relative to "resistant" patients treated with nivolumab. A signature consisting of 274 mass spectrometry features was associated with progression-free survival and overall survival across two validation groups. The study demonstrated that this serum-derived proteomic signature successfully stratified outcomes in groups of advanced NSCLC patients treated with second line PD-1 checkpoint inhibitors.

The paper was authored by Mirte Muller, Karlijn Hummelink, Daan P. Hurkmans, Anna-Larissa N. Niemeijer, Kim Monkhorst, Joanna Roder, Carlos Oliveira, Heinrich Roder, Joachim G. Aerts and Egbert F Smit and published online in Clinical Cancer Research on July 6, 2020.

On July 16, 2020 Oncorus, Inc., a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that it has initiated a Phase 1 study of its lead product candidate, ONCR-177, an intratumorally administered oncolytic Herpes Simplex Virus (oHSV) viral immunotherapy being developed for multiple solid tumor indications (Press release, Oncorus, JUL 16, 2020, View Source [SID1234561981]). The Phase 1 open-label, multi-center, dose escalation and expansion study is designed to evaluate the safety and tolerability and to determine the recommended Phase 2 dose as well as preliminary anti-tumor activity of ONCR-177 alone and in combination with Merck’s anti-PD1-1, KEYTRUDA (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors.

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"Initiating our first-in-human study of ONCR-177 is a significant milestone, bringing us a major step closer to delivering on our mission to realize the full promise of viral immunotherapy for cancer patients across multiple indications, including some of the most notoriously difficult-to-treat types of cancer," said Theodore (Ted) A. Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "Our oHSV Platform represents a potential breakthrough for the viral immunotherapy class due to the multiple proprietary innovations our team has developed to activate multiple arms of the immune system to enhance potency while balancing safety."

Dr. Ashburn continued, "A huge thank you to our team and collaborators for their tremendous effort preparing for this study amidst the unprecedented challenges presented by the COVID-19 pandemic. I’m proud and honored to work with such a bright, dedicated and patient-driven group of people."

"While we have seen great success with immuno-oncology as an approach in some patients, these therapies have not benefited all patients with cancer, and new strategies are needed," said Shiraj Sen, M.D., Ph.D., Associate Director, Drug Development Unit, Sarah Cannon Research Institute at HealthONE in Denver, Colorado. "Given its differentiated profile, ONCR-177 has the potential to enable more patients to respond to, and realize the benefits of, immuno-oncology treatment. We are pleased to be part of this important first-in-human study of this next-generation viral immunotherapy." Dr. Sen is a site investigator for the ONCR-177 Phase 1 study, and his site enrolled and dosed the first patient in this trial.

John Goldberg, M.D., Senior Vice President of Clinical Development at Oncorus, commented, "We are privileged to be working with preeminent cancer research institutions and leading researchers on the execution of this study. We are also thrilled to enter a clinical collaboration with Merck to study ONCR-177 in combination with KEYTRUDA, which is a key component of the trial. Above all, we are humbled to now be in a study in patients with ONCR-177 and believe in its potential to become a foundational component of oncologists’ anti-tumor arsenal. Our team is motivated by the courage of cancer patients and driven to enable every patient to win their war against this disease."

Oncorus has designed its proprietary oHSV Platform to develop improved intratumorally administered viral immunotherapies that have the potential to enhance potency without sacrificing safety, a challenge that has been encountered by earlier generation programs in this class. ONCR-177 is designed to mount a powerful, multidimensional attack on cancer; it induces immunogenic cancer cell death and ignites innate and adaptive immunity to drive a lasting and systemic anti-tumor response. In addition to its oncolytic activity, ONCR-177 is armed with five immunomodulatory transgenes: IL-12, CCL4, FLT3LG, and antagonists of clinically proven immune checkpoints PD-1 and CTLA-4. This represents a greater payload capacity than viral immunotherapies that are either currently approved or in clinical development.

In preclinical studies, ONCR-177 was shown to stimulate multiples arms of the immune system, drive abscopal activity and prolong survival while limiting systemic exposure to transgene products, such as IL-12, that generally cannot be safely dosed systemically due to toxicities.

ONCR-177 retains full replication competency to enable potent tumor cell killing. It also incorporates two highly innovative approaches — the use of microRNA target sequences and a proprietary mutation engineered in an HSV-1 protein, known as UL37 — to allow for tumor-specific replication, which restricts viral activity to tumor cells while sparing normal tissues.

About the Phase 1 ONCR-177 Study

The first part of the study involves a monotherapy dose escalation of ONCR-177 and will enroll approximately 21 cancer patients with advanced or metastatic solid tumors for whom surgical resection or locoregional therapy is not indicated, and who are refractory to, ineligible for, relapsed from and/or intolerant of standard of care treatment or have a disease for which no standard of care exists.The Phase 1 trial will escalate the dose of ONCR-177 until the recommended phase 2 dose is determined.

Upon determination of the recommended Phase 2 dose, the study will then enroll patients to histology- specific expansion cohorts to demonstrate safety and initial efficacy of ONCR-177 as a monotherapy and in combination with KEYTRUDA, in addition to enabling biomarker exploration. The expansion cohorts will enroll patients with solid tumors who are refractory to, ineligible for, relapsed from and/or intolerant of standard of care treatment or have a disease for which no standard of care exists, including patients with breast cancer, squamous cell carcinoma of the head and neck (SCCHN), and melanoma.