On January 6, 2022 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, reported that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for margetuximab, an investigational, Fc-engineered monoclonal antibody that targets HER2 (Press release, Zai Laboratory, JAN 6, 2022, View Source [SID1234598348]). The margetuximab NDA is for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease, in combination with chemotherapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are pleased to have NMPA’s acceptance of our NDA for margetuximab, which is the only HER2-targeted agent to have shown a progression-free survival (PFS) improvement versus trastuzumab in SOPHIA, a head-to-head global Phase 3 clinical trial," said Alan Sandler, MD, President and Head of Global Development, Oncology, at Zai Lab. "Both SOPHIA and Zai Lab’s registrational bridging trial support the potential use of margetuximab as an important new treatment option for a very difficult-to-treat patient population. The potential approval of margetuximab will also be an important addition to our growing women’s oncology franchise and marks Zai Lab’s sixth NDA acceptance by the NMPA."

"Early detection and treatment of breast cancer have had a positive impact on patient survival. However, we still need to improve the prognosis for people diagnosed with HER2-positive metastatic breast cancer, and additional anti-HER2 targeted therapies are needed," said Professor Zefei Jiang, Chairman of Chinese Society of Clinical Oncology (CSCO) Breast Cancer Expert Committee and Deputy Director of Department of Oncology, Chinese PLA General Hospital. "Zai Lab’s bridging study confirmed the clinical benefit of margetuximab in Chinese patients. We are excited to see this potential new treatment option for patients living with metastatic breast cancer in China."

In December 2020, MacroGenics, Inc. announced that the U.S. Food and Drug Administration (FDA) approved margetuximab (brand name MARGENZA) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. The approval was based on efficacy and safety results from the pivotal Phase 3 SOPHIA trial.

In October 2021, Zai Lab announced that the bridging study of margetuximab plus chemotherapy as compared with trastuzumab plus chemotherapy in advanced, previously treated HER2-positive breast cancer patients met its primary endpoint, median PFS evaluated by blinded independent central review (BICR). The safety profile was consistent with that seen in the SOPHIA study. Zai Lab is planning to present the detailed study results at an upcoming medical conference.

About Margetuximab

MARGENZA (margetuximab-cmkb) is an Fc-engineered monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Similar to trastuzumab, margetuximab-cmkb inhibits tumor cell proliferation, reduces shedding of the HER2 extracellular domain and mediates antibody-dependent cellular cytotoxicity (ADCC). However, through MacroGenics’ Fc Optimization technology, margetuximab-cmkb has been engineered to enhance the engagement of the immune system. In vitro, the modified Fc region of margetuximab-cmkb increased binding to the activating Fc receptor FCGR3A (CD16A) and decreased binding to the inhibitory Fc receptor FCGR2B (CD32B). These changes led to greater in vitro ADCC and NK cell activation. The clinical significance of in vitro data is unknown.

About Breast Cancer in China

Breast cancer is the most common cancer in Chinese women, with 416,371 newly diagnosed cases and 117,174 deaths in 20201. Approximately 25%-30% of all types of late-stage breast cancer are HER2-positive2,3. Monoclonal antibodies targeting HER2 have greatly improved outcomes; however, a significant number of patients progress to later lines of therapy. Effective treatments for metastatic HER2-positive breast cancer continue to remain an unmet need.

Source: (1) Globocan 2020; (2) The role of HER2 in cancer therapy and targeted drug delivery, Wanyi Tai, Rubi Mahato, and Kun Cheng; (3) Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications, Nida Iqbal and Naveed Iqbal.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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.

On January 6, 2022 Sanofi and Exscientia reported a groundbreaking research collaboration and license agreement to develop up to 15 novel small molecule candidates across oncology and immunology, leveraging Exscientia’s end-to-end AI-driven platform utilizing actual patient samples (Press release, Exscientia, JAN 6, 2022, View Source [SID1234598385]). The companies have been working together since 2016 and in 2019, Sanofi in-licensed Exscientia’s novel bispecific small molecule candidate capable of targeting two distinct targets in inflammation and immunology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We look forward to deepening our work with Exscientia, a leader in leveraging AI to modernize all aspects of drug discovery and development," said Frank Nestle, Global Head of Research and Chief Scientific Officer, Sanofi. "Sanofi’s collaboration with Exscientia aims to transform how we discover and develop new small molecule medicines for cancer and immune-mediated diseases. Application of sophisticated AI and machine learning methods will not only shorten drug discovery timelines, but will also help to design higher quality and better targeted medicines for patients."

Exscientia and Sanofi will collaborate to identify and select target projects, leveraging Exscientia’s personalised medicine platform. The platform enables a "patient-first" approach through integrating primary human tissue samples into early target and drug discovery research. By doing so, Exscientia scientists can integrate patient, disease, and clinically relevant data into decisions on potential new medicine candidates earlier in the drug creation process. In addition to target discovery, Exscientia will lead small molecule drug design and lead optimization activities up to development candidate nomination, with Sanofi assuming responsibility for preclinical and clinical development, manufacturing and commercialization.

"It is immensely exciting to collaborate with Sanofi with our goal of realizing the full potential of AI to deliver the next generation of cancer and immunology medicines," said Andrew Hopkins, DPhil, CEO and founder of Exscientia. "Our AI-driven platform can be leveraged across drug discovery, translational research and development, with applications ranging from improving the precision medicine and quality of drug candidates to enriching for patient selection in clinical trials. Our expanded collaboration with Sanofi will utilise the breadth of our platform to test AI-designed drug candidates against patient tissue models, potentially providing far better accuracy than conventional approaches such as mouse models. When you consider the change this represents – testing candidates against actual human tissue years before a clinical trial – it’s transformative."

Under the terms of the agreement, Exscientia will receive an upfront cash payment of $100 million from Sanofi and will be eligible to receive future research, translational, clinical development, regulatory and commercial milestone payments of up to approximately $5.2 billion in aggregate, if all milestones for all programs are achieved. In the case that Sanofi commercializes a therapeutic from the collaboration, Exscientia will also be eligible to receive tiered royalties on product sales ranging from high-single-digits to mid-teens and an option for clinical co-investment to increase the royalty rate up to 21% on net sales of co-funded products. The upfront cash payment of $100 million is expected to be reflected in the first quarter 2022 financial results of Exscientia as cash inflows from collaborations and recognized as revenue over the duration of the agreement.

On January 6, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that it has entered into an agreement with The University of Texas Health Science Center at San Antonio (also referred to as UT Health San Antonio) for a worldwide exclusive license to develop and commercialize novel interventional therapeutics for cancer (Press release, Cytori Therapeutics, JAN 6, 2022, View Source [SID1234598315]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"The future of cancer therapy is precise targeting of tumors with the most potent cancer-killing agents while minimizing damage to normal tissues," stated Marc H. Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "Not only does this important transaction further expand our existing Rhenium NanoLiposome technology, but it also helps realize this future. With this technology, we can target almost any solid organ tumor in the body using standard interventional means to leverage the breadth of the human vascular system and deliver a resorbable biomaterial embolic technology coupled with a highly potent radiotherapeutic isotope."

The licensed patents include composition of matter patents for biodegradable alginate microspheres (BAM) containing nanoliposomes loaded with imaging and/or therapeutic payloads. Therapeutic payloads may include radiotherapeutics, chemotherapeutics or thermotherapeutics. The BAM technology is delivered into the vascular system via standard interventional vascular catheters that are placed precisely in the vessels feeding tumors. Once injected, BAM blocks all blood flow to the tumors and simultaneously delivers very high doses of cytotoxic compounds for an extended time. Many days later, the BAM resorbs and are physiologically metabolized and excreted from the body.

"Embolization technology for many types of tumors, including liver cancer, has been used with promising results for over two decades, but substantial limitations remain, and no meaningful recent technological innovations have been made," said William Phillips, M.D., Professor of Nuclear Medicine at UT Health San Antonio. "The leading radioembolization therapies available today incorporate Yttrium-90 glass/resin microspheres which have poor imaging characteristics, require long lead times, are permanently implanted and may expose the marrow to high levels of radiation. Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (188RNL-BAM) is a next generation, fully resorbable technology that solves many of the problems of existing technology. Our team at UT Health San Antonio intends to support Plus Therapeutics in bringing this technology rapidly to market."

The financial terms of the exclusive license agreement are primarily success-based with milestone and royalty payments contingent on achieving key clinical, regulatory and sales milestones.

The Company will initially focus on developing 188RNL-BAM as a next-generation radioembolization therapy for liver cancer, in which BAM blocks the hepatic artery segments that supply blood to the malignant tumor while also providing 188RNL radiotherapy by directly irradiating the tumor.

"This transaction is the next step in our plan to expand our pipeline using precision, targeted radiotherapeutics," said Norman LaFrance, M.D., Chief Medical Officer of Plus Therapeutics. "Next steps are to complete and compile the promising preclinical work performed thus far and prepare for an IND submission in 2022 for the treatment of liver cancer."

Liver cancer is a rare disease with an increasing annual incidence and 5-year overall survival of only 20%1. The global opportunity for localized embolization, chemoembolization, and radioembolization therapies for primary (hepatocellular carcinoma) and secondary (typically metastatic colorectal cancer, for example) liver cancer is $1.3 billion2.

The initial inventions and work behind the licensed patents and technologies were developed and led by William Phillips M.D., Professor of Nuclear Medicine, Ryan Bitar, M.D., and their team at UT Health San Antonio. The 188RNL-BAM technology incorporates Rhenium-188, or 188Re, a very attractive isotope for use in radiotherapeutic embolization owing to its emission of a high energy electron (beta particle) with a half-life of 16.9 hours and a path length of 3.1 mm. 188Re emits gamma energy that permits high quality, real-time imaging of the BAM construct delivery localization and confirmation. 188RNL-BAM is straightforward and cost-effective to manufacture for on-demand availability for therapeutic applications and is versatile and can be precisely composed and manufactured to a specific size allowing optimal arterial embolization to block blood flow in most vascular beds while simultaneously delivering its isotopic payload to the tumor. BAMs are not permanent like other technology and degrade over time, allowing restoration of blood flow, decreasing radiation resistance, and allowing safer physiological and safe clearance of 188Re through the kidneys, which avoids bone marrow toxicity.

1American Cancer Society; 2Internal estimate

On January 6, 2022 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported that Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS, will present during two virtual investor conferences in January (Press release, Scynexis, JAN 6, 2022, View Source [SID1234598332]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Presentation details:

LifeSci Partners 11th Annual Corporate Access Event
Format: Virtual panel discussion with CEO and 1:1 meetings
Panel Title: The Best of Both Worlds – Defining Yourself When You Fit into More Than One Basket
Date and Time: Friday, January 7, at 10:00 a.m. ET
Registration link: LifeSci Partners Corporate Access Event 2022
H.C. Wainwright Bioconnect 2022 Virtual Healthcare Conference
Format: Virtual event with webcast of corporate update presentation by Dr. Taglietti
Date and Time: Presentation webcast will be available on-demand January 10-13 for event participants
Registration link: H.C. Wainwright Bioconnect 2022
The latest SCYNEXIS investor presentation can be found on the corporate website here.