On March 30, 2021 Schrödinger (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported that it will host a webcast to review the preclinical data being presented from its CDC7 program during a virtual poster session at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Schrodinger, MAR 30, 2021, View Source [SID1234577376]). The company will also provide an overview of two other internal programs, MALT1 and Wee1, as well as highlight the role of its computational platform in accelerating the discovery of its novel molecules. The webcast will take place Monday, April 12, 2021, at 10:00 a.m. ET.

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The webcast will be available under "News & Events" in the investors section of Schrödinger’s website, View Source and will be archived for approximately 7 days.

On March 30, 2021 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints reported the closing of a $73 million Series B1 and B2 financing (Press release, Immune-Onc Therapeutics, MAR 30, 2021, View Source [SID1234577375]). The round was led by Oceanpine Capital with participation from additional new investors including Octagon Capital and Sphera Healthcare, and existing investors, including Northern Light Venture Capital and Vivo Capital. In conjunction with this round of financing, Oceanpine CEO and managing partner Dave Chenn joins the Immune-Onc Board of Directors. In addition, the company received a strategic capital investment from The Leukemia & Lymphoma Society’s Therapy Acceleration Program (LLS TAP), directed toward advancing the company’s work to treat blood cancers.

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"We are delighted that this high-caliber group of new and existing investors share our excitement about the transformative potential of myeloid checkpoint inhibition and believe in Immune-Onc’s ability to deliver on this promise with our pipeline of first-in-class cancer immunotherapies," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "This round of investment was substantially over-subscribed, enabling the company to accelerate the clinical development of multiple novel assets, and deliver what we believe is the next breakthrough in immunotherapy treatment for many of the world’s most devastating cancers."

Proceeds from the financing will allow Immune-Onc to advance its portfolio of blood cancer and solid tumor immunotherapies targeting myeloid checkpoints with a focus on the LILRB family. Immune-Onc has raised more than $110 million from investors since the company began operations in 2016. In August 2020, the company announced it had been awarded a Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to support clinical development of IO-202.

"We are enthusiastic about Immune-Onc’s novel approach to cancer immunotherapy targeting myeloid checkpoints and their leading portfolio of first-in-class assets," said Dave Chenn, CEO and managing partner of Oceanpine Capital. "We have full confidence in the company’s highly experienced management team and are excited to be at the forefront of this new area of research and development through our investment in Immune-Onc supporting their next phase of growth."

Immune-Onc’s Pipeline

Immune-Onc’s research and development programs focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints to overcome immune resistance of cancer. The company has invested in proprietary models, assays and tools to interrogate the biology and translate this cutting-edge research into the development of novel therapies.

Immune-Onc’s lead program IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), is being developed to treat blood cancers, including acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML), and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a "don’t kill me" to a "kill me" signal by activating T cell killing and converts a "don’t find me" to a "find me" signal by inhibiting infiltration of hematologic cancer cells.

In September 2020, Immune-Onc initiated a Phase I trial evaluating IO-202 in AML with monocytic differentiation and in CMML. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation status for treatment of AML in October 2020. The company is also evaluating IO-202 in solid tumors and will present preclinical data for the first time on April 10, 2021 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (#AACR21).

Immune-Onc has active preclinical programs targeting other members of the LILRB family including IO-108, a novel antagonist antibody targeting LILRB2 (also known as ILT4) which is currently in the IND-enabling stage. The company presented preclinical data supporting IO-108 for the treatment of solid tumors at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting and plans to submit an investigational new drug application in mid-2021. Other preclinical assets include IO-106, a first-in-class anti-LAIR1 antibody, and multiple undisclosed programs for solid tumors and hematologic malignancies.

About The Leukemia & Lymphoma Society and Therapy Acceleration Program (TAP)

The Leukemia & Lymphoma Society (LLS) is a global leader in the fight against cancer. The LLS mission is to cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families. LLS TAP is a strategic initiative that builds business alliances and collaborations with biotechnology companies and academic researchers to identify potential breakthrough therapies with the ability to change the standard of care. LLS TAP funds late-stage pre-clinical studies, and proof of concept or registrational clinical trials to help advance therapeutics along the drug development and approval pathway. To learn more, visit www.LLS.org/therapy-acceleration-program. Follow LLS on Facebook, Twitter, and Instagram.

On March 30, 2021 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 third quarter of fiscal year 2021, which ended February 28, 2021 (Press release, AngioDynamics, MAR 30, 2021, View Source [SID1234577374]).

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"I am pleased with our strong third quarter performance, driven by continued strength in our AngioVac and Auryon platforms. Our revenue grew 2% year over year despite continued COVID-19 headwinds, particularly in January and the first half of February. Further, we are encouraged by the recent improvements in our end markets and increasing availability of vaccines," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "We continue to execute on our strategy to drive revenue growth through our key technology platforms: Auryon, AngioVac, and NanoKnife. In addition, our balanced approach to cash and expense management continues to yield profitability on an adjusted basis while allowing us to invest in the development and progression of these key platforms. I am excited about the planned launch of our new mechanical thrombectomy device later in calendar 2021, as well as a number of other planned product improvements and clinical and regulatory pathway expansions that will open up opportunities for us in larger, higher-growth markets."

Third Quarter 2021 Financial Results

Net sales for the third quarter of fiscal 2021 were $71.2 million, an increase of 2.0% compared to the prior-year quarter. Net sales in the third quarter continued to be impacted 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.

Vascular Interventions and Therapies ("VIT") net sales were $33.3 million, an increase of 8.8%, compared to $30.6 million a year ago. Growth was driven primarily by increased sales of the Company’s Auryon and AngioVac platforms compared to the previous year. This growth was partially offset by a decline in sales of Venous products resulting from a decline in elective procedure volumes due to the ongoing COVID-19 global pandemic. Auryon sales during the quarter were $3.3 million.
Oncology net sales were $13.1 million, a decrease of 10.1% from $14.6 million in the prior-year period. The year-over-year decline was primarily attributable to lower capital sales and ongoing procedure impacts of COVID-19, particularly in international markets, partially offset by continued growth in sales of NanoKnife disposables in the United States.
Vascular Access net sales were $24.8 million, compared to $24.6 million a year ago.
U.S. net sales in the third quarter of fiscal 2021 were $58.7 million, an increase of 6.9% from $54.9 million a year ago. International net sales were $12.5 million in the third quarter of fiscal 2021 compared to $14.9 million a year ago.

Gross margin for the third quarter of fiscal 2021 was 54.1%, a decline of 370 basis points compared to the third quarter of fiscal 2020. Consistent with the first half of the year, the year-over-year decline in gross margin was primarily due to Auryon start-up costs and the Company’s previously discussed COVID-related operating plan, including under-absorption of the Company’s manufacturing facilities attributable to additional operating protocols designed to secure the supply-chain and prioritize employee safety. In addition, gross margin was negatively impacted by staffing challenges in the Company’s upstate New York manufacturing facility. During the third quarter, inventory was reduced by $0.6 million when compared to inventory levels on November 30, 2020. During the fiscal year, inventory levels have been reduced by $10.9 million.

The Company recorded a net loss of $3.5 million, or loss per share of $0.09, in the third quarter of fiscal 2021. This compares to a net loss of $5.7 million, or loss per share of $0.15, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the third quarter of fiscal 2021 was $0.7 million, and adjusted earnings per share was $0.02, compared to adjusted net income in the prior-year period of $0.4 million and adjusted earnings per share of $0.01. Adjusted net income and adjusted earnings per share in the third quarter of fiscal 2021 includes a $1.9 million, and $0.04 per share benefit, respectively, related to the reimbursement of certain expenses under the CARES Act.

Adjusted EBITDA in the third quarter of fiscal 2021, excluding the items shown in the reconciliation table below, was $5.4 million, compared to $3.8 million in the third quarter of fiscal 2020.

In the third quarter of fiscal 2021, the Company generated $5.9 million in operating cash and had capital expenditures of $1.4 million. As of February 28, 2021, the Company had $54.5 million in cash and cash equivalents compared to $58.0 million in cash and cash equivalents on November 30, 2020. The Company reduced its debt outstanding under its revolving credit facility at February 28, 2021, to $30.0 million compared to $40.0 million at November 30, 2020. Subsequent to the end of the third fiscal quarter, the Company further reduced debt outstanding under the revolving credit facility to $20 million. Management remains focused on cash preservation and expense management amid the current environment.

Nine Months Financial Results

For the nine months ended February 28, 2021:

Net sales were $214.2 million, an increase of 4.1%, compared to $205.8 million for the same period a year ago.
The Company’s net loss was $12.1 million, or a loss of $0.32 per share, compared to a net loss of $9.7 million, or a loss of $0.26 per share, a year ago.
Gross margin decreased 490 basis points to 53.4% from 58.3% a year ago due to the Company’s COVID-related operating plan and Auryon start-up costs.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $1.9 million, with adjusted earnings per share of $0.05, compared to adjusted net income and adjusted earnings per share of $5.7 million, and $0.15, respectively, a year ago.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $15.0 million, compared to $17.5 million for the same period a year ago.
Fiscal Year 2021 Financial Guidance

The Company is increasing its guidance for fiscal year 2021. Management now projects net sales between $285 and $288 million and fiscal year 2021 adjusted earnings per share between $0.04 and $0.06, compared to previous projections of net sales between $278 and $284 million and adjusted earnings per share between $0.00 and $0.05.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2021 third quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13717367.

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 Tuesday, March 30, 2021, until 11:59 p.m. ET on Tuesday, April 6, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13717367.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income, adjusted earnings per share, and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.

On March 30, 2021 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported that the first patient has been dosed in the Phase 2 portion of a study evaluating NT-I7 (efineptakin alfa), a novel long-acting human IL-7, in patients with newly diagnosed, non-severe lymphopenic high grade glioma (HGG), following standard radiation therapy and temozolomide (Press release, NeoImmuneTech, MAR 30, 2021, View Source [SID1234577373]). The investigator-initiated trial is being conducted by neuro-oncologist Jian Li Campian, M.D., Ph.D., of Washington University School of Medicine in St. Louis.

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The primary endpoint of the Phase 2 part of this study is to measure the effect of NT-I7 on absolute lymphocyte count (ALC) compared to placebo control.

"Standard radiation and chemotherapy can reduce the number and function of immune cells in HGG patients, so it is essential to investigate therapeutic options that can support the rejuvenation of T cells and combat lymphopenia in these patients," said Dr. Campian, an Associate Professor of Medicine at Washington University. "Evidence suggests that NT-I7 can increase lymphocyte count and may stimulate the immune response, and we’ll be evaluating its potential for improving treatment outcomes for patients with HGG."

"Current conventional therapy for HGG is insufficient, with only 25% of patients surviving more than 1 year, and new treatment options are in dire need," added NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. "We are excited to see the potential utility of our unique T cell amplifier, NT-I7, in a larger patient group and look forward to evaluating its potential to enhance the standard of care and improve patient outcomes."

More information can be found at www.neoimmunetech.com or www.clinicaltrials.gov, identifier: NCT03687957.

About High Grade Gliomas

High grade gliomas (HGGs) indicate collectively the presence of grade 3 or 4 malignant tumors, which tend to grow rapidly and spread faster than tumors of a lower grade, in brain tissue. Standard therapy for HGGs such as glioblastoma includes both surgery and chemotherapy. The average survival rate is about 12 months, relatively shorter than other solid tumors. When glioblastoma patients are treated with standard radiation and chemotherapy, approximately 40% experience a severe reduction in their immune cells, especially T cells. Recent data suggest that the inferior survival rate in patients with glioblastoma is associated with very low T cell counts.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On March 30, 2021 Flatiron Health reported that Carolyn Starrett, leader of the company’s community oncology business, will become CEO, effective April 16 (Press release, Flatiron Health, MAR 30, 2021, View Source [SID1234577372]).

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Starrett will succeed Co-Founder/CEO Nat Turner who, along with Co-Founder/COO Zach Weinberg, will step down from Flatiron management on April 16.

"I am honored and energized by the opportunity to lead Flatiron in our next chapter," said Starrett, who joined Flatiron in 2016. "I love Flatiron – our mission, our people, our culture. I’m excited to lead us to even greater impact on patient care and innovation in the field of real-world data, and to build a workforce that reflects the diversity of the many people who live with cancer."

Founded in 2012, Flatiron has built the leading U.S. oncology real-world data source, from which its experts aggregate, de-identify, and curate clinical, genomic, and other data modalities for research purposes. More than 280 community cancer clinics across the United States center their practices on Flatiron’s OncoCloud platform and services, and Flatiron also partners with major academic cancer centers, more than 20 top developers of oncology therapeutics, and researchers and regulators across the United States and internationally.

"It has been a privilege to help nurture the pioneering start-up born from Nat and Zach’s vision into the global leader in real-world evidence that Flatiron is today," said Severin Schwan, CEO of Roche Group, which acquired Flatiron as an independent affiliate in 2018. "Carolyn’s passion for Flatiron, her experience in technology and healthcare, and her ability to rally people around a shared vision are the perfect mix to lead Flatiron’s next life stage. I look forward to continued partnership and support."

"We conducted an extensive search and could not have been happier to realize that the right candidate was already here at home," said Turner, who will remain Chair of Flatiron’s Board of Directors. "It’s time for a new leader to take Flatiron to the next level, and I have every confidence in handing over the reins to Carolyn."