On January 7, 2021 Abcuro, Inc., a clinical-stage biotechnology company developing therapies for autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, reported the closing of a $42 million Series A-1 financing and the appointment of John B. Edwards as the Executive Chair of the Board of Directors and David de Graaf, Ph.D. as Chief Executive Officer (Press release, Abcuro, JAN 7, 2021, View Source [SID1234573653]). The financing was co-led by Mass General Brigham Ventures and Sanofi Ventures, and included investors Pontifax Venture Capital, Hongsen Investment Group, RA Capital Management and Samsara BioCapital, as well as others.

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Concurrent with this financing, Jason Hafler, Ph.D. from Sanofi Ventures, Iyona Rajkomar from Pontifax Venture Capital, Ryan Berry, Ph.D. from RA Capital Management and Donald McCarthy, Ph.D. from Samsara BioCapital have joined the Abcuro Board of Directors which also includes Julius Knowles from Mass General Brigham Ventures and Yajun Xu, Ph.D., President of Hongsen Investment Group.

"Over the past year, Abcuro has developed a compelling data package to support this round of financing to advance our lead program into the clinic," said Mr. Edwards, Executive Chair. "We have been encouraged with the level of venture and pharma interest in Abcuro’s pioneering work directed at precision targeting of cytotoxic T and NK cells. We are particularly excited to welcome David as CEO as we enter this pivotal period of growth for Abcuro."

Proceeds from this financing will be used to advance ABC008, an anti-KLRG1 antibody designed to deplete cytotoxic T cells that attack healthy tissue in a variety of autoimmune diseases. A first-in-human proof of mechanism and safety trial will be conducted in patients with sporadic inclusion body myositis (IBM) while additional indications are under investigation. IBM is a chronic and debilitating inflammatory skeletal muscle condition with no available pharmaceutical therapies. The Series A-1 proceeds will also support ongoing preclinical development of the company’s oncology program ABC015, an anti-KLRG1 blocking antibody capable of restoring effector cytotoxic T and NK cell function, resulting in a potent anti-tumor response. This includes financial and scientific support by the Multiple Myeloma Research Foundation to assess ABC015 in multiple myeloma.

"KLRG1 is a compelling target in immune modulation in both autoimmune diseases and cancer as it allows us to precisely target clinically relevant cytotoxic T and NK cells," said Dr. de Graaf. "I’m very pleased by the shared excitement of Abcuro’s investors in pursuing the clinical potential of targeting KLRG1."

Mr. Edwards brings more than thirty years of experience in discovery, development and global commercialization of biopharmaceuticals to Abcuro. He was involved in the development or commercialization of ten FDA approved biologics and has had successful exits at eight of the ten biotech companies he helped to build, including Tilos, Siamab, Exonics, Adnexus, F-star and Genetics Institute. He built a hematology therapeutic business that eventually reached over $1B in annual revenue for Wyeth/Genetics Institute and was responsible for leading the development of the fastest biologic to progress from phase I to FDA approval.

Dr. de Graaf is a pioneer in the biotech industry with an impressive record of advancing programs into the clinic. Most recently, he was the CEO of Comet Therapeutics. Prior to Comet, he was CEO of Syntimmune, a clinical-stage biotechnology company focused on advancing novel treatments for IgG-mediated autoimmune diseases. His experience includes leadership roles at Apple Tree Partners, Selventa, Boehringer-Ingelheim, Pfizer and AstraZeneca. He holds a Ph.D. in genetics from the University of Illinois at Chicago.

On January 7, 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 second quarter of fiscal year 2021, which ended November 30, 2020 (Press release, AngioDynamics, JAN 7, 2021, View Source [SID1234573652]).

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"I am very pleased with our performance in the second quarter, as sales execution and continued expense management drove strong revenue and positive earnings," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "AngioVac and Auryon performed well during the quarter, as we continue to focus on growing our key technology platforms while managing expenses throughout the business. In the second half of the year, we expect ongoing COVID-related headwinds as well as typical third-quarter seasonality, which is contemplated in our full-year guidance. We are excited about the planned launch of our multi-purpose mechanical aspiration thrombectomy device in calendar 2021, as this new member of the AngioVac platform family will position us to serve the much larger addressable market of moderately complex thrombectomy cases, while AngioVac and Uni-Fuse continue to address the complex and simple ends of the spectrum, respectively."

Second Quarter 2021 Financial Results

Net sales for the second quarter of fiscal 2021 were $72.8 million, an increase of 4.0% compared to the prior-year quarter. Net sales in the second 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 $33.9 million, an increase of 8.8%, compared to $31.2 million a year ago. Growth was driven by increased AngioVac sales over the previous year, partially offset by a decline in sales of Venous products resulting from lower elective procedure volumes. Auryon sales during the quarter were $2.1 million.
Oncology net sales were $14.9 million, a decrease of 7.0% from $16.0 million a year ago. The year-over-year decline was primarily attributable to lower capital sales, which were somewhat offset by strong growth in sales of NanoKnife disposables, particularly in the United States.
Vascular Access net sales were $23.9 million, an increase of 5.0% from $22.8 million a year ago.
U.S. net sales in the second quarter of fiscal 2021 were $60.7 million, an increase of 9.2% from $55.6 million a year ago. International net sales were $12.1 million in the second quarter of fiscal 2021, a decrease of 16.3% from $14.4 million a year ago.

Gross margin for the second quarter of fiscal 2021 was 55.2%, a decline of 410 basis points compared to the second quarter of fiscal 2020. The gross margin decline was primarily attributable to the Company’s previously discussed COVID-related operating plan. This plan included under-absorption of the Company’s manufacturing facilities related to additional COVID-related operating protocols designed to ensure supply-chain security and employee safety. Additionally, during the second quarter, inventory was reduced by $3.2 million when compared to inventory levels on August 31, 2020. Since year end, inventory levels have been reduced by $10.3 million.

The Company recorded a net loss of $4.3 million, or loss per share of $0.11, in the second quarter of fiscal 2021. This compares to net loss of approximately $2.7 million, or loss per share of $0.07, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the second quarter of fiscal 2021 was $0.6 million or adjusted earnings of $0.01 per share, compared to adjusted net income of $2.2 million, or adjusted earnings per share of $0.06, in the second quarter of fiscal 2020.

Adjusted EBITDA in the second quarter of fiscal 2021, excluding the items shown in the reconciliation table below, was $5.2 million, compared to $6.4 million in the second quarter of fiscal 2020.

In the second quarter of fiscal 2021, the Company generated $11.5 million in operating cash and had capital expenditures of $1.4 million. As of November 30, 2020, the Company had $58.0 million in cash and cash equivalents compared to $47.9 million in cash and cash equivalents on August 31, 2020. As of November 30, 2020, the Company had $40.0 million in debt outstanding, consistent with its debt balance on August 31, 2020. Subsequent to quarter end, the Company repaid $10 million of its outstanding debt. Management remains focused on cash preservation amid the current environment.

Six Months Financial Results

For the six months ended November 30, 2020:

Net sales were $143.0 million, an increase of 5.1%, compared to $136.0 million for the same period a year ago.
The Company’s net loss was $9.0 million, or a loss of $0.22 per share, compared to a net loss of $4.0 million, or a loss of $0.11 per share, a year ago.
Gross margin decreased 550 basis points to 53.1% from 58.6% a year ago due to the Company’s previously discussed COVID-related operating plan.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $1.2 million, or $0.03 per share, compared to adjusted net income of $5.3 million, or $0.14 per share, a year ago.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $9.6 million, compared to $13.7 million for the same period a year ago.
Fiscal Year 2021 Financial Guidance

The Company continues to expect fiscal year 2021 net sales in the range of $278 to $284 million and fiscal year 2021 adjusted earnings per share in the range of $0.00 to $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 second 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 13714154.

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, January 7, 2021, until 11:59 p.m. ET on Thursday, January 14, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13714154.

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 January 7, 2021 AVEO Oncology (Nasdaq: AVEO) reported its recent progress and outlined its 2021 outlook (Press release, AVEO, JAN 7, 2021, View Source [SID1234573650]).

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"We remain keenly focused on building out our commercial team ahead of the potential U.S. launch of tivozanib as a treatment for relapsed or refractory renal cell carcinoma (RCC), including the addition of Dr. Corinne Epperly to our Board of Directors," said Michael Bailey, president and chief executive officer of AVEO. "If approved, we believe tivozanib has the potential to serve as a new treatment for the rapidly growing population of patients with relapsed or refractory RCC. In support of the further clinical and commercial development of tivozanib, we have identified opportunities to potentially extend its patent exclusivity period."

Mr. Bailey added: "In addition to our launch preparation, we continue to make great progress advancing our clinical pipeline, with each asset expected to reach an important milestone this year. These include progress in our immunotherapy combination programs for tivozanib, a decision on whether to initiate a pivotal study of ficlatuzumab in head and neck squamous cell carcinoma (HNSCC), and the execution of our Phase 1 study of AV-380. We believe 2021 will be a transformational year for AVEO, and we look forward to delivering on a number of milestones designed to enhance our long-term value."

Key Recent Program Updates and Anticipated 2021 Milestones

Tivozanib U.S. Regulatory and Commercial Updates

Commercial Readiness Nearing Completion in Support of Potential Tivozanib U.S. Launch. Commercial preparations are well underway to support the potential U.S. launch of tivozanib, AVEO’s vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) drug candidate, as a treatment for relapsed or refractory RCC. U.S. sales leadership, sales training, marketing, market access and medical affairs teams as well as distribution capabilities are now in place. Hiring, training, and deployment of the Company’s field sales organization is on track for completion ahead of the U.S. Food and Drug Administration’s (FDA) New Drug Application Prescription Drug User Fee Act target action date for tivozanib of March 31, 2021.
Relapsed/Refractory RCC Disease Awareness Website Launched for U.S. Healthcare Professionals. The Company reported the recent launch of www.ReimagineRCC.com, a relapsed/refractory RCC disease awareness resource for U.S. healthcare professionals highlighted by the headline: "After multiple prior treatments in renal cell carcinoma (RCC), the journey can quickly become a challenge". The website highlights the need for more robust data and better tolerated treatment options to support the roughly half of patients who receive second line therapy yet do not continue therapy beyond progression.
Corporate Updates

Updated IP Strategy Offers Potential for Tivozanib Patent Term Extension to November 2028. AVEO holds an exclusive license to two issued U.S. patents for tivozanib, one pertaining to the tivozanib composition of matter, which expires in April 2022, and the other pertaining to a crystalline form of tivozanib, which expires in November 2023. A patent term extension of up to five years may be available under the Hatch-Waxman Act, although only one patent can be extended under the Act. The Company currently intends to file applications for patent term extension on both patents in parallel to provide optionality in its exclusivity strategy. Depending upon which patent the Company ultimately chooses to extend, if a full five year extension is granted for such patent, tivozanib’s exclusivity period could reach either April 2027 or November 2028.
Corinne D. Epperly, MD, MPH Appointed to Board of Directors. AVEO reported the appointment of Corinne D. Epperly, MD, MPH, to its Board of Directors. Dr. Epperly brings over 15 years of experience in oncology as a physician and scientist, blending medicine and business with a proven track record in oncology drug development and launches, commercial and medical strategy, marketing, M&A, and operations gained at Iovance Biotherapeutics, VBL Therapeutics, Bristol Myers Squibb, Goldman Sachs, and the National Cancer Institute of the NIH.
Tivozanib Immuno-Oncology Updates

Results from Phase 1b/2 TiNivo Study of Tivozanib in Combination with OPDIVO (nivolumab) in RCC Published in Annals of Oncology. In November 2020, AVEO announced that previously reported results from the Phase 1b/2 TiNivo study of oral (PO) tivozanib (FOTIVDA) in combination with intravenous (IV) nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced RCC, were published in Annals of Oncology. The article, titled "TiNivo: Safety and Efficacy of Tivozanib-Nivolumab Combination Therapy in Patients with Metastatic Renal Cell Carcinoma", is available online first via this link. AVEO plans to detail next steps in its investigations of the tivozanib-nivolumab combination following potential FDA approval of tivozanib.
Results from the Phase 1b Portion of DEDUCTIVE Study to Be Presented Friday, January 15, 2021, at ASCO (Free ASCO Whitepaper) GI Cancer Symposium. AVEO is also studying tivozanib in combination with IMFINZI (durvalumab), AstraZeneca’s human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with first line metastatic hepatocellular carcinoma in the Phase 1b/2 DEDUCTIVE clinical trial, which is currently in Phase 2, with enrollment expected to complete this year. Results from the Phase 1b portion of the DEDUCTIVE study are expected to be presented at on Friday, January 15, 2021, at 8:00 am ET, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium.
Ficlatuzumab Update

Enrollment Complete in Phase 2 Open Label Randomized Study of Ficlatuzumab in HNSCC; Results Expected to Be Presented at a Medical Meeting in Mid-2021; Phase 3 Decision on Track for Mid-2021. The Company announced today that enrollment is now complete in its randomized confirmatory Phase 2 study of ficlatuzumab as a single agent or in combination with cetuximab, an EGFR-targeted antibody, in metastatic HNSCC patients who have failed prior immunotherapy, chemotherapy and cetuximab (ERBITUX). Ficlatuzumab is AVEO’s potent hepatocyte growth factor (HGF) inhibitor antibody which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. The study was designed to confirm findings from a Phase 1/2 study of ficlatuzumab and cetuximab where the combination was well tolerated and resulted in a disease control rate of 67%, as well as prolonged progression-free survival (PFS) and overall survival (OS) compared to historical controls.

Results from the Phase 2 study are expected to be presented at a medical meeting in mid-2021. In that timeframe, the Company plans to announce a Phase 3 decision for ficlatuzumab. In September 2020, AVEO regained full global rights to ficlatuzumab and has initiated clinical manufacture of ficlatuzumab to supply a potential Phase 3 clinical trial in HNSCC, as well as additional potential Phase 2 studies in pancreatic cancer and acute myeloid leukemia.
AV-380 Update

Phase 1 Clinical Study Initiated Following U.S. FDA Acceptance of IND Filing. The Company announced today that its investigational New Drug Application (IND) application for AV-380, its first-in-class, potent, humanized inhibitory antibody targeting GDF15, for the treatment of cancer cachexia, has been accepted by the FDA. Cachexia, a common complication in patients with advanced cancer and other chronic diseases, is a complex metabolic syndrome characterized by malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue, as well as the clinical manifestation of anemia, inflammation and suppression of immune functions. A Phase 1 study in healthy subjects has been initiated.
About Tivozanib (FOTIVDA)

Tivozanib is an oral, once-daily, next-generation VEGFR TKI discovered by Kyowa Kirin Co. and approved as FOTIVDA for the treatment of adult patients with advanced RCC in the European Union and other countries in the territory of the Company’s partner, EUSA Pharma (UK) Limited (EUSA territory). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for adult patients with relapsed or refractory advanced RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.4 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin Co. in non-oncology indications.

On January 7, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that the Company will participate in the J.P. Morgan 39th Annual Healthcare Conference on Thursday, January 14, 2021 at 5:20 p.m. ET (Press release, BeiGene, JAN 7, 2021, View Source [SID1234573649]).

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A live webcast can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available for 90 days following the event.

On January 7, 2021 Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer and pre|CISION platforms, reported that it has entered into a license agreement with POINT Biopharma Inc. ("POINT"), to provide access to Avacta’s pre|CISION technology for the development of tumour-activated radiopharmaceuticals (Press release, Avacta, JAN 7, 2021, View Source [SID1234573648]).

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The radiopharmaceutical market is expected to grow to $15 billion by 20251 and there is a substantial opportunity to grow much faster if safety and tolerability of these effective treatments can be improved. POINT Biopharma is a clinical-stage pharmaceutical company focused on developing radioligands2 as precision medicines for the treatment of cancer.

Avacta’s proprietary pre|CISION chemistry can be used to modify a radioligand drug to form a tumour-activated prodrug. The prodrug form is inactive in circulation until it enters the tumour micro-environment where it is activated by an enzyme called fibroblast activation protein (or FAP) that is present in high abundance in most solid tumours but not in healthy tissue. Avacta’s pre|CISION technology therefore has the potential to improve the tolerability and achieve better clinical outcomes for patients compared with standard radiopharmaceuticals by targeting the radioligand treatment more specifically to cancer cells.

The agreement provides POINT with an exclusive license to the pre|CISION technology for use in the first radiopharmaceutical prodrug the company intends to develop, and a non-exclusive license to the pre|CISION platform for the development of a broader pipeline of FAP-activated radiopharmaceuticals.

Under the terms of the agreement, Avacta will receive an upfront fee and development milestones for the first radiopharmaceutical prodrug totaling $9.5 million. Avacta will also receive milestone payments for subsequent radiopharmaceutical prodrugs of up to $8 million each, a royalty on sales of FAP-activated radiopharmaceuticals by POINT and a percentage of any sublicensing income received by POINT.

Alastair Smith, Chief Executive Officer of Avacta Group, commented: "I am very pleased to have established this partnership with POINT that allows Avacta to exploit its pre|CISION platform in a therapeutic area outside of our in-house focus on chemotherapy prodrugs.

The clinical and commercial rationale for our pre|CISION prodrug platform is to improve the safety and efficacy of many existing drugs, as well as generating a pipeline of new and novel cancer therapies. In oncology, we believe that this approach will result in better response rates for monotherapies, and a greater safety margin, to enable their use with a larger patient population and as part of combination therapies.

The in-house development of AVA6000 Pro-doxorubicin, the first of our pre|CISION chemotherapy prodrugs for which we have recently submitted a CTA filing in the UK to begin clinical trials in 2021, has already generated significant interest and this is highlighted by the agreement with POINT announced today.

The potential of the pre|CISION platform to significantly improve outcomes for patients treated with existing cancer therapies through improved safety, tolerability and dosing regimens is enormous. In addition, Avacta is combining the pre|CISION technology with the Affimer platform to create an entirely new class of proprietary TMAC drug conjugates.

I look forward to updating the market on further progress on these and the diagnostic programmes across the Group in the near term."