On January 6, 2022 ATCC, the world’s premier biological materials management and standards organization, reported that it has been awarded a contract with Leidos Biomedical Research, Inc. (Leidos Biomed), current operator of the Frederick National Laboratory for Cancer Research, for the continued production, characterization and distribution of next-generation cancer models (NGCM) (Press release, Leidos, JAN 6, 2022, View Source [SID1234598373]). These models will be distributed solely by ATCC as part of the National Cancer Institute’s (NCI) Human Cancer Model Initiative (HCMI), an international consortium that is generating novel, next-generation, tumor-derived culture models annotated with genomic, clinical and biospecimen data. In consultation with the HCMI team at Leidos Biomed and the Center for Cancer Genomics (CCG) at NCI, the contract will add 70 additional NGCMs to HCMI’s current catalog of 182 models – all of which will be available as a community resource through its data portal.

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"We recognize that the industry needs more biologically relevant cancer models and are well positioned to ensure that this expanded collection of diverse NGCMs is available to the scientific community through the HCMI," said Raymond H. Cypess, D.V.M., Ph.D., chairman and CEO of ATCC.

NGCMs are invaluable for in vitro studies as they more closely mimic the in vivo disease characteristics. The new models from primary, metastatic and recurrent cancers will expand the types of cancers represented and increase the number of patient-derived tumors available for study. New cancer types potentially released under this contract include but are not limited to bladder, endometrial, head and neck, ovarian, pediatric, and rare cancer, as well as desmoid tumor, lymphoma, and neuroblastoma.

"ATCC is at the core of enabling breakthroughs in cancer research by collaborating with HCMI to provide well-characterized 2D and 3D models for R&D studies," said James Clinton, Lead Scientist at ATCC. "These patient-derived in vitro cancer models will include 2D conditionally reprogrammed cells (CRCs) and 3D neurospheres and organoids grown in a cellular matrix that better recapitulate the in vivo environment than adherent cell lines."

Using detailed methodologies and key technical inputs developed and shared by the HCMI Cancer Model Development Centers (CMDCs), scientists at ATCC have successfully replicated and compiled model-specific, easy-to-follow culture protocols and a video for the 3D model, containing everything that will be required to initiate, expand, and cryopreserve organoids embedded in 3D culture. They will also provide guidance and advice to fellow scientists working with NGCMs in their own laboratories.

"With this contract, ATCC will expand its commitment to the NCI’s mission to improve human health by providing the scientific community with in vitro tools like NGCMs to study cancer, identify and target novel therapies, and facilitate translational cancer research," said Joseph Leonelli, Ph.D., Senior Vice President of ATCC Federal Solutions. "We look forward to supporting HCMI’s efforts to prioritize the development of solutions to advance cancer research worldwide."

On January 6, 2022 RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, reported that Ken Song, M.D., President and CEO of the Company, will be presenting at the 40th Annual J.P. Morgan Healthcare Conference being held virtually on Tuesday, January 11, 2022 (Press release, RayzeBio, JAN 6, 2022, View Source [SID1234598372]).

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J.P. Morgan Healthcare Conference
Date: Tuesday, January 11, 2022
Time: 11:00 a.m. – 11:25 a.m. EST
Please click on the below link to find additional details about the J.P. Morgan Healthcare Conference
View Source

On January 6, 2022 RenovoRx, Inc. (NASDAQ: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported that Shaun Bagai, Chief Executive Officer, will participate in the H.C. Wainwright Bioconnect Virtual Conference on behalf of RenovoRx (Press release, Renovorx, JAN 6, 2022, View Source [SID1234598371]). The conference will be held January 10-13, 2022.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Mr. Bagai’s investor presentation will be available on-demand beginning January 10th at 7:00 am EST.

Management will be available during the H.C. Wainwright Bioconnect conference for 1-on-1 meetings with the investment community. To schedule a meeting please reach out to your H.C. Wainwright representative or KCSA Strategic Communications by emailing [email protected].

For further information about the H.C. Wainwright Bioconnect conference and to register to attend virtually click here.

A webcast of the event will be available for a limited time on the Events page in the Investors section of the Company’s website at View Source

On January 6, 2022 Gennao Bio, a privately held genetic medicines company developing first-in-class, targeted nucleic acid therapeutics, reported the appointments of Joseph W. McIntosh, M.D., as chief medical officer, and Anuj Goswami, J.D., MBA, as general counsel (Press release, Gennao Bio, JAN 6, 2022, View Source [SID1234598370]).

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"We are thrilled to welcome Joe and Anuj to the Gennao Bio team. Joe is a proven leader with significant expertise in rare disease and oncology drug development and Anuj has deep legal experience leading financing and M&A transactions, as well as corporate governance, IP, and compliance activities for life science companies," said Stephen Squinto, Ph.D., chief executive officer and chair of the board of Gennao Bio. "These appointments reflect the tremendous growth of our organization, and our dedication to bringing together a best-in-class team to develop our GMAB platform for oncology and rare monogenic skeletal muscle diseases."

Dr. McIntosh joins Gennao with more than 16 years of drug development experience in the biopharmaceutical industry, with a focus on gene therapies and rare genetic disease. Previously, he served as chief medical officer for Jaguar Gene Therapy, responsible for the development of the company’s AAV9-based gene therapies. Prior to Jaguar, he served as chief medical officer at Aruvant Sciences, overseeing the clinical development of the company’s investigational gene therapy for sickle cell disease. Earlier in his career, he held positions of increasing leadership at PTC Therapeutics, NPS Pharmaceuticals, Eisai and Pfizer. Before joining the biopharma industry, he trained in emergency medicine at Kent and Canterbury Hospital in the UK. Dr. McIntosh earned a bachelor’s degree in chemistry and biochemistry and a medical degree from the University of Witwatersrand in South Africa.

Mr. Goswami joins the Gennao team with over 20 years of experience in private practice at Ballard Spahr LLP in Philadelphia. As a partner in Ballard’s Business & Finance practice, he served numerous clients through various stages of the growth cycle, leading multi-disciplinary teams to support a range of early stage and public company clients. Mr. Goswami brings a breadth of expertise advising clients in the life sciences, technology, and retail sectors on a variety of matters, including equity and debt financing, corporate governance, M&A transactions and employment law. He received his B.A. in economics from Haverford College and his J.D. and MBA from The Ohio State University.

On January 6, 2022 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 2022, which ended November 30, 2021 (Press release, AngioDynamics, JAN 6, 2022, View Source [SID1234598369]).

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"We are pleased with our continued strong revenue growth as our team navigates this dynamic macro environment and manages through persistent COVID headwinds," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics. "Revenue growth this quarter was driven by our Med Tech platforms, particularly our atherectomy and thrombectomy portfolios. The ongoing disruptions from the COVID pandemic and resulting labor and supply chain headwinds led to a $4.0 million backlog at quarter end, impacting our gross margin and earnings. We have implemented measures to address these challenges. Our solid revenue growth and this backlog illustrate the strong demand for our products in the marketplace, and, despite these challenges, we remain firmly in investment mode. I am confident in our team’s ability to sustain the growth of our portfolio over time as we execute on our strategic plan to transform the company through investment in key growth technologies like our AlphaVac F22 mechanical thrombectomy system, which entered full market release in early December."

Second Quarter 2022 Financial Results

Net sales for the second quarter of fiscal 2022 were $78.3 million, an increase of 7.6% compared to the prior-year quarter.

Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Med Tech net sales were $18.9 million, a 36.4% increase from $13.8 million in the prior year period, while Med Device net sales were $59.4 million, an increase of 0.8% compared to $58.9 million in the prior year period. Med Tech includes the Auryon Peripheral Atherectomy platform, thrombectomy and the NanoKnife irreversible electroporation platform. The Company’s performance during the quarter was particularly impacted by increasing supply chain constraints, as well as headwinds driven by lower procedural volumes that impacted some of the Company’s product lines. Hospitals faced meaningful staffing challenges during the quarter, in addition to increased COVID-related restrictions.

Endovascular Therapies (formerly Vascular Interventions and Therapies) net sales were $39.7 million, an increase of 17.0%, compared to $33.9 million a year ago. Growth was driven by strength in our atherectomy and thrombectomy portfolios relative to the prior-year period. Auryon sales during the quarter were $6.3 million, as the Company continued to see sequential sales growth of this platform.
Oncology net sales were $13.6 million, a decrease of 9.3%, compared to $14.9 million in the prior-year period. The year-over-year decline was largely due to lower capital sales, partially offset by increased sales of disposables.
Vascular Access net sales were $25.1 million, an increase of 4.8%, compared to $23.9 million a year ago.
U.S. net sales in the second quarter of fiscal 2022 were $65.4 million, an increase of 7.7% from $60.7 million a year ago. International net sales were $12.9 million, an increase of 7.0%, compared to $12.1 million a year ago.

Gross margin for the second quarter of fiscal 2022 was 51.8%, a decrease of 340 basis points compared to the second quarter of fiscal 2021. During the quarter, gross margin was negatively impacted by macro forces including labor shortages and under absorption of fixed costs as well as increased expense for raw materials, labor, and freight. Gross margins were also impacted by startup costs related to Auryon and AlphaVac.

The Company recorded a net loss of $8.4 million, or a loss per share of $0.21, in the second quarter of fiscal 2022. This compares to a net loss of $4.3 million, or a loss per share of $0.11, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net loss for the second quarter of fiscal 2022 was $0.9 million, and adjusted loss per share was $0.02, compared to adjusted net income in the prior-year period of $0.6 million and adjusted earnings per share of $0.01.

Adjusted EBITDA in the second quarter of fiscal 2022, excluding the items shown in the reconciliation table below, was $4.4 million, compared to $5.2 million in the second quarter of fiscal 2021.

In the second quarter of fiscal 2022, the Company generated $1.9 million in operating cash, had capital expenditures of $1.1 million and additions to Auryon placement and evaluation units of $2.7 million. As of November 30, 2021, the Company had $34.3 million in cash and cash equivalents compared to $35.5 million in cash and cash equivalents on August 31, 2021. The Company had debt outstanding of $25.0 million on November 30, 2021, compared to $25.0 million on August 31, 2021.

Six Months Financial Results

For the six months ended November 30, 2021:

Net sales were $155.3 million, an increase of 8.6%, compared to $143.0 million for the same period a year ago.
The Company’s net loss was $15.3 million, or a loss of $0.39 per share, compared to a net loss of $8.5 million, or a loss of $0.22 per share, a year ago.
Gross margin decreased 110 basis points to 52.0% from 53.1% a year ago.
Excluding the items shown in the non-GAAP reconciliation table, below, adjusted net loss was $1.7 million, with adjusted loss per share of $0.04, compared to adjusted net income and adjusted earnings per share of $1.2 million, and $0.03, respectively, a year ago.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $8.0 million, compared to $9.6 million for the same period a year ago.
Reiterating Fiscal Year 2022 Revenue Guidance; Revising Gross Margin and Adjusted EPS Guidance

The Company continues to expect its fiscal year 2022 net sales to be in the range of $310 to $315 million. Gross margin is now expected to be in the range of 52.0% to 54.0%, a decrease from the Company’s prior guidance of 55.0%, as headwinds persist regarding labor shortages and inflationary pressures on raw materials and transportation. Due to the macroeconomic pressures on gross margin, as discussed above, the Company now expects adjusted earnings per share in the range of a loss of $0.02 to a gain of $0.02, below its prior guidance of a 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 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 13725681.

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 6, 2022, until 11:59 p.m. ET on Thursday, January 13, 2022. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13725681.