On February 9, 2022 Checkmate Pharmaceuticals, Inc. (Nasdaq: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported the appointment of Alan Bash as President and Chief Executive Officer, effective March 1, 2022 (Press release, Checkmate Pharmaceuticals, FEB 9, 2022, View Source [SID1234607897]). Mr. Bash, who will also join the Board of Directors, will succeed Alan Fuhrman, who has served as interim President and Chief Executive Officer since October 2021. Mr. Fuhrman will continue to serve Checkmate as a member of the Board of Directors.

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"I am very pleased to welcome Alan Bash as President and CEO. With over two decades of leadership experience at Bristol Myers Squibb, Mr. Bash has extensive expertise translating innovative science into meaningful advances for patients, notably driving the successful launch and commercialization of Opdivo and Yervoy," said Mike Powell, Chairman of the Board of Directors. "Under Alan’s leadership, Checkmate will continue developing novel treatments for patients with difficult-to-treat cancers. The Company’s lead program vidutolimod, continues to progress in multiple clinical studies and towards registration in refractory melanoma. I want to thank Mr. Fuhrman for his outstanding stewardship as interim President and CEO over these past months."

"I am honored to be joining an experienced management team, an accomplished Board and a Company built on the potential to improve the lives of those living with cancer," said Mr. Bash. "Vidutolimod combines a powerful, unique immune activator, CpG-A DNA, with an innovative delivery platform, that has demonstrated potential best-in-class efficacy in certain patients whose tumors were non-responsive to approved immunotherapies."

Mr. Bash’s appointment follows the recent additions of Jon Wigginton, M.D. and Joy Yan, M.D., Ph.D. to the Checkmate Board of Directors. These appointments provide complementary leadership and immuno-oncology expertise and position Checkmate well to advance the development of vidutolimod and unlock its value potential.

Mr. Bash will join Checkmate from Bristol Myers Squibb ("BMS"), where he currently serves as Senior Vice President, Commercial Model Innovation, and prior to that, Senior Vice President, Commercial for Immunology and Fibrosis, partnering with Research & Development to advance early and late-stage assets in the integrated BMS and Celgene portfolios. He has a deep expertise in immuno-oncology, having led the U.S. launch of the PD-1 checkpoint inhibitor, Opdivo; serving as franchise lead for metastatic melanoma; and leading the launch of the first FDA-approved checkpoint combination. He also served as Worldwide Vice President for BMS’s lung cancer franchise and led the product team for a targeted treatment for head and neck cancer and colorectal cancer. He earned his BA from Georgetown University and his MBA from Columbia Business School.

On February 9, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that it will webcast its Quarterly Update Conference Call for the fourth quarter 2021 on Tuesday, February 22 at 4:30 p.m. ET / 1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the fourth quarter and year ended December 31, 2021, following the close of trading (Press release, Halozyme, FEB 9, 2022, View Source [SID1234607913]).

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To register for this conference call, please use this link: View Source After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call.

The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investor’s page of www.halozyme.com approximately 15 minutes prior to the call to register, download and install any necessary audio software. A telephone replay will be available for two weeks after the call by dialing (800) 770-2030 (domestic callers) or (647) 362-9199 (international callers) using replay ID number 44868.

On February 9, 2022 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the publication of a peer-reviewed case study by researchers at The University of Texas MD Anderson Cancer Center in Clinical and Translational Radiation Oncology (Press release, Nanobiotix, FEB 9, 2022, View Source [SID1234607928]). The case study reports on the first patient experience of treatment with potential first-in-class radioenhancer, NBTXR3, in pancreatic ductal adenocarcinoma (PDAC; pancreatic cancer).

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Given the nature of NBTXR3 as a therapeutic candidate with potentially broad applicability across solid tumor indications and therapeutic combinations, Nanobiotix and MD Anderson are collaborating to expand development of NBTXR3 beyond the Company’s priority pathways in locally advanced head and neck squamous cell carcinoma and immunotherapy. This ongoing phase I pancreatic cancer study is one of five active phase I or phase II studies currently being conducted as part of the collaboration.

The phase I clinical trial is designed to determine the safety profile of NBTXR3 activated by radiotherapy (RT) for patients with locally advanced or borderline resectable PDAC, and the recommended phase II dose (RP2D) for future efficacy evaluation. The case study in Clinical and Translational Radiation Oncology reports on the first patient ever to receive local endoscopic delivery of NBTXR3 to a deep visceral tumor. The patient is a 66-year-old male with unresectable, locally advanced PDAC who received local endoscopic delivery of NBTXR3 followed by intensity modulated RT. CT imaging demonstrated no visible leakage of the radioenhancer outside of the injected tumor. At initial follow-up evaluation, the lesion remained radiographically-stable, the patient did not demonstrate treatment-related toxicity, and the report concluded that the treatment was feasible.

PDAC is one of the leading causes of cancer-related death in the world today. For patients with PDAC who are not eligible for surgery, RT has been shown to improve local disease control. However, safely delivering therapeutic doses of radiation remains challenging due to off-target toxicities in surrounding healthy tissues. While systemic radiosensitizers have been evaluated in this indication, these agents increase the sensitivity of both tumor tissues and healthy tissues. In contrast, due to the potential of NBTXR3 to increase the dose of RT within the tumor without increasing the dose in surrounding healthy tissues, the radioenhancer is being evaluated as a new option to address this urgent unmet need.

"There is a critical need to develop an effective therapy to improve treatment outcomes while mitigating off-target toxicities for patients with locally advanced pancreatic cancer," said Eugene Koay, MD, PhD, associate professor of Radiation Oncology at MD Anderson. "The initial feasibility for NBTXR3 injection outlined in this case study provides an important step forward as we determine the recommended phase II dose and the potential for the radioenhancer to help patients with this challenging disease."

Nanobiotix expects to establish the recommended phase II dose for NBTXR3 in pancreatic cancer in 2022.

About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product, composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physics-based mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly, with immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study, evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and for patients with lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy, either naïve or resistant to prior PD-1 (either primary or secondary as per SITC (Free SITC Whitepaper) criteria).

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in strategic collaborations to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations. In 2021, the Company entered into an additional strategic collaboration agreement with LianBio to support its global phase III study in Asia along with four future registrational studies.

On February 9, 2022 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease with three ongoing Phase 1 clinical trials, reported that company management will participate in the 11th Annual SVB Leerink Global Healthcare Conference being held February 14-18, 2022 (Press release, Shattuck Labs, FEB 9, 2022, View Source [SID1234607946]).

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Presentation Details
Conference: 11th Annual SVB Leerink Global Healthcare Conference
Format: Corporate Presentation
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: February 18, 2022
Time: 10:40 a.m. EST

A live webcast of the presentation will be available on the Events & Presentations section of the Company’s website. A replay of the webcasts will be archived for up to 90 days following the presentation date.

On February 9, 2022 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported financial results for the year and the six months ended December 31, 2021 (Press release, Purple Biotech, FEB 9, 2022, View Source [SID1234607877]).

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"We achieved significant progress in the advancement of our promising oncology pipeline during this year with notable data releases in both of our lead candidates," said Gil Efron, President and Chief Financial Officer of Purple Biotech. "For NT219, we are currently treating patients in the fourth dose cohort monotherapy arm of the ongoing Phase 1/2 clinical trial and have initiated the first dose level in the combination arm of the study together with cetuximab for patients with squamous cell carcinoma of head and neck (SCCHN). For CM24, we are about to complete dose escalation of the phase 1b/2 of the study and will soon initiate the expansion arms of the study in non-small-cell lung cancer (NSCLC) and pancreatic cancer. We are encouraged by the preliminary data reported from the first patients treated in each of the studies released in 2021 and are planning to expand both programs to additional promising indications in 2022."

"We continue to be focused on development of our robust oncology programs, supported by a strong balance sheet. With $47.4 million in cash, cash equivalent, short and long-term deposits at the end of December 2021, our cash runway extends into 2024," concluded Mr. Efron.

Financial Results for the Year Ended December 31, 2021

Research and Development Expenses were $11.8 million, an increase of $4.6 million, or 64%, compared to $7.2 million in the same period of 2020. The increase was due to expenses related to the ongoing NT219 and CM24 clinical trials, including the manufacturing of drug for the studies.

Selling, General and Administrative Expenses were $6.1 million, compared to $6.0 million in the same period of 2020, an increase of $0.1 million.

Operating Loss was $17.9 million, an increase of $4.7 million, or 36%, compared to $13.2 million in the same period of 2020. The increase was mainly due to the increase in research and development expenses.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $15.8 million, an increase of $5.2 million, compared to $10.6 million in the same period of 2020, mainly due to the increased expenses for clinical studies and manufacturing of drug for these studies.

Net Loss for 2021 was $18.5 million, or $1.05 per basic and diluted share, compared to a net loss of $28 million, or $2.45 per basic and diluted share, in 2020. The decrease in net loss was mainly due to $15.7 million in expenses related to a change in the fair value of derivatives, offset by an increase of $4.7 million in operating expenses. Adjusted net loss for the year was $15.7 million, an increase from $10.4 million in the full year of 2020.

As of December 31, 2021, Purple Biotech had cash and cash equivalents and short- and long-term deposits of $47.4 million, compared to $60.8 million on December 31, 2020. The Company believes that its cash position will provide sufficient resources to support its currently anticipated ongoing needs into 2024.

Discontinued Operation. As previously reported, COVID-19 adversely impacted the launch of Consensi in the United States. In October 2021, the Company agreed, together with its then U.S distributor for Consensi, Coeptis Pharmaceuticals Inc., to terminate the distribution agreement. Despite our efforts to identify an alternative distributor for Consensi in the U.S., we concluded that commercialization of Consensi, both in the U.S market and elsewhere, is not likely to generate significant revenue and achieve profitability in the near term. In order to reduce the expenses involved in maintaining the product, it was concluded to discontinue Consensi activities and to allocate the funds to our core oncology activities. In parallel, the agreements with Kuhnil Pharmaceuticals Inc.’s for the territory of South Korea and Hebei Changshan Biochemical Pharmaceutical Co., Ltd. for the territory of China were terminated. Consequently, the Company is reporting Consensi as a discontinued operation. Loss from discontinued operation in 2021 was $0.6 million compared to profit from discontinued operation of $0.6 million in 2020. The decrease in profit is mainly due to a decrease in Consensi revenues of $1.0 million generated in 2020.

Financial Results for the Six Months Ended June 30, 2021

Research and Development Expenses were $4.9 million, an increase of $0.6 million, or 14%, compared to $4.3 million in the same period of 2020. The increase was due to expenses related to the CM24 clinical trials that started in the first half of 2021.

Selling, General and Administrative Expenses were $2.9 million, compared to $3.9 million in the same period of 2020, a decrease of $1 million. The decrease was mainly due to a $0.9 million decrease in employee equity-based compensation (ESOP) costs.

Operating Loss was $7.8 million, a decrease of $0.5 million, or 6%, compared to $8.3 million in the same period of 2020.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $7.1 million, a decrease of $0.7 million, compared to $6.4 million in the same period of 2020, mainly to decrease in Selling, General and Administrative Expenses offset by increase in R&D expenses.

Net Loss for the second half of 2021 was $8.3 million, or $0.47 per basic and diluted share, compared to a net loss of $0.2 million, or $0.01 per basic share and $0.47 per diluted share, in the second half of 2020. The increase in net loss was mainly due to decrease of $7.9 million in income related to a change in the fair value of derivatives, offset by an increase of $0.5 million in operating expenses and decrease of $1 million in revenues. Adjusted net loss for the second half of 2021 was $7.0 million, an increase from $6.3 million in the second half of 2020.