On March 9, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported a presentation that Joseph C. Papa, chairman and CEO, Sam Eldessouky, senior vice president and corporate controller, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to present at the Barclays Global Healthcare Conference today, March 9, 2021, at 2:25 p.m. ET (Press release, Bausch Health, MAR 9, 2021, View Source [SID1234576357]).

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The presentation, which provides an update on Bausch Health’s current pipeline for Salix, including an update regarding its rifaximin clinical development efforts, is available on the Investor Relations page of the Bausch Health Companies Inc. website at: View Source A live webcast and audio archive of the event will also be available on the Investor Relations page of the Company’s website.

On March 9, 2021 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the full-year ended December 31, 2020 and recent corporate highlights (Press release, Checkpoint Therapeutics, MAR 9, 2021, View Source [SID1234576306]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We are very pleased with our momentum throughout 2020, solidifying the registration path for cosibelimab in metastatic cutaneous squamous cell carcinoma ("mCSCC"), as well as announcing positive interim data from our pivotal Phase 1 program. Checkpoint’s registration-enabling study in mCSCC is approximately 90% enrolled, with full enrollment anticipated shortly. We remain on track to report full top-line results in the second half of 2021. With a potentially favorable safety profile and plan to commercialize at a lower net price, we believe cosibelimab, if approved, has the potential to be a market disruptive product in the $25 billion and growing PD-(L)1 class. We look forward to a transformative year as we continue our progress towards our first BLA submission with the U.S. Food and Drug Administration ("FDA") for cosibelimab in 2022."

2020 and Recent Corporate Highlights:

In January 2020, Checkpoint announced confirmation of the registration path for cosibelimab in mCSCC. FDA feedback supports the plan to submit a BLA based on data from the ongoing Phase 1 clinical trial.
In April 2020, Checkpoint announced that the U.S. Patent and Trademark Office issued a composition of matter patent for cosibelimab. U.S. Patent No. 10,590,199 specifically covers the antibody, cosibelimab, or a fragment thereof, providing protection through at least May 2038, exclusive of any additional patent-term extensions that might become available.
In September 2020, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, Checkpoint announced updated positive interim results from the ongoing global, open-label, multicohort, Phase 1 clinical trial of cosibelimab in patients with advanced cancers, including the registration-enabling cohort of patients with mCSCC. Cosibelimab demonstrated a 51.4% objective response rate ("ORR") and 13.5% complete response rate, which was nearly double the complete response rate observed at the time of the previous analysis.
Also in September 2020, Checkpoint closed on gross total proceeds of approximately $20.5 million in an underwritten public offering of its common stock, before deducting underwriting discounts and commissions and other offering-related expenses.
In November 2020, Checkpoint’s collaboration partner in Asia for CK-101, Neupharma Inc., initiated a Phase 3, registration-enabling study of CK-101 in first-line, EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer ("NSCLC"). Checkpoint plans to meet with the FDA to discuss the ongoing Phase 3 study design and its potential use, upon a successful study, to support a new drug application submission in the United States.
Also in November 2020, Checkpoint announced the expansion of a long-term manufacturing partnership for cosibelimab with Samsung Biologics. Building upon an existing contract manufacturing agreement entered into in 2017, Samsung Biologics will provide additional commercial-scale drug substance manufacturing for cosibelimab.
Also in November 2020, Checkpoint announced updated interim results from the ongoing global, open-label, multicohort Phase 1 clinical trial of cosibelimab in patients with advanced cancers, including a cohort of patients with previously untreated high PD-L1 expressing advanced NSCLC. The updated interim results were presented in a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting held virtually. Cosibelimab demonstrated a 44.0% ORR and 10.3-month median progression-free survival in the NSCLC cohort. A Phase 3 registration-enabling trial is planned in first-line metastatic NSCLC.
In March 2021, Checkpoint announced the formation of a Scientific Advisory Board comprised of industry thought leaders. Members include Wayne A. Marasco, M.D., Ph.D., F. Stephen Hodi, Jr., M.D., Bruce E. Johnson, M.D., David Miller, M.D., Ph.D., and Emily Ruiz, M.D., M.P.H.
Financial Results:

Cash Position: As of December 31, 2020, Checkpoint’s cash and cash equivalents totaled $40.8 million, compared to $26.1 million at December 31, 2019, an increase of $14.7 million. Cash and cash equivalents as of December 31, 2020 does not include approximately $12.0 million of net proceeds from the utilization of the Company’s At-the-Market Issuance Sales Agreement during the first quarter of 2021 at an average price of $3.88.
R&D Expenses: Research and development expenses for the year ended December 31, 2020, were $16.4 million, compared to $19.3 million for the year ended December 31, 2019, a decrease of $2.9 million. Research and development expenses for the year ended December 31, 2020 included $5.2 million of non-cash stock expenses, compared to $3.2 million in non-cash stock expenses for the year ended December 31, 2019.
G&A Expenses: General and administrative expenses for the year ended December 31, 2020 were $7.9 million, compared to $7.2 million for the year ended December 31, 2019, an increase of $0.7 million. General and administrative expenses for the year ended December 31, 2020 included $3.1 million of non-cash stock expenses, compared to $3.2 million in non-cash stock expenses for the year ended December 31, 2019.
Net Loss: Net loss attributable to common stockholders for the year ended December 31, 2020 was $23.1 million, or $0.41 per share, compared to a net loss of $24.7 million, or $0.70 per share, for the year ended December 31, 2019.

On March 9, 2021 PerkinElmer, Inc., (NYSE: PKI) a global leader committed to innovating for a healthier world, reported that the Company has completed its previously announced acquisition of Oxford Immunotec Global PLC (Oxford Immunotec) (Press release, PerkinElmer, MAR 9, 2021, View Source [SID1234576322]). PerkinElmer originally announced its intent to acquire Oxford Immunotec on January 7, 2021.

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"Oxford Immunotec’s global role in fighting tuberculosis, particularly its trademark product, the T-SPOT.TB test, and the operations it has built are remarkable," said Prahlad Singh, PerkinElmer president and chief executive officer. "We recognize the distinct clinical and logistical advantages of the test and see a great opportunity to leverage our automation capabilities and commercial channel access to bring tuberculosis testing to more customers around the world."

Headquartered in Abingdon, UK, Oxford Immunotec is recognized as a global leader of proprietary test kits for latent tuberculosis. Its Interferon Gamma Release Assay (IGRA) offering identifies individuals who are infected with tuberculosis. Oxford Immunotec had approximately 275 global employees as of September 30, 2020 and reported total revenue from continuing operations of $73.74 million and $39.2 million as of the fiscal year ended December 31, 2019 and the nine months ended September 30, 2020, respectively.

On March 9, 2021 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported 2021 financial guidance (Press release, Bavarian Nordic, MAR 9, 2021, View Source [SID1234576339]).

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In 2021, Bavarian Nordic expects revenue between DKK 1,900 million and DKK 2,200 million and an EBITDA between DKK 100 million and DKK 250 million. Cash and cash equivalents at year-end are expected to be between DKK 300 million and DKK 500 million, excluding proceeds from offering.

Key assumptions

Revenue:

The low end of the revenue range reflects a scenario where a lockdown due to COVID-19 continues beyond Q1 in key markets like the US and Germany. The higher end of the revenue range reflects a scenario where a gradual reopening will happen in key markets during Q2 and where travel starts picking up again in Q3 and Q4 of 2021.
The smallpox and Ebola business are not expected to be impacted by COVID-19.
Research and development:

Research and development costs of approximately DKK 750 million are expected for 2021. The single largest project in 2021 is the RSV project for which manufacturing of phase 3 material as well as cost for the announced Human Challenge Trial is included. For the COVID-19 program up to approximately DKK 200 million are expected for a phase 2 trial and scale-up of manufacturing in preparation for a phase 3 trial. These costs are being capitalized and hence the research and development costs expensed through the P&L are expected to be approximately DKK 550 million.
Cash position:

Expected payment of approximately DKK 375 million milestones to GSK relating to the tech-transfer process for Rabipur/RabAvert and Encepur.
Working capital changes of approximately DKK 300 million, primarily driven by increased inventory levels of Encepur and Rabipur/RabAvert products.
Investments of approximately DKK 650 million with the vast majority of the investment linked directly to the acquired vaccines Rabipur/RabAvert and Encepur and relates to the upgrade of the bulk facility and capitalized tech-transfer costs.
Draw-down of existing EUR 30 million loan facility with the European Investment Bank.
Investment in COVID-19 program of up to approximately DKK 200 million (capitalized R&D costs)
Investments:

Approximately half of the total investments relates to the new facility. The design of the facility has been revised to achieve a higher degree of flexibility enabling parallel manufacturing of Bavarian Nordic developed products and allowing space for specific Encepur/Rabipur/RabAvert equipment. The re-design has increased the total expected investments related to the plant to approximately DKK 650 million from previously announced DKK 450 million and the re-build is expected to be finalized in 2022.
Capitalization of tech-transfer costs in 2021 is expected to reach approximately DKK 150-200 million.
Beyond 2022, and with current plans, annual investments are expected to decline to a level of DKK 50 – 100 million.
The outlook is based on the following currency exchange rate assumptions: DKK 6.10 per 1 USD and DKK 7.45 per 1 EUR.

On March 9, 2021 Alphamab Oncology (stock code: 9966.HK) reported that U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug application (IND) to initiate an open label, multi-center phase II pivotal clinical study (clinical trial No.: KN046-205) in the United States to evaluate the efficacy, safety and tolerability of KN046 (PD-L1/CTLA-4 bispecific antibody) for the treatment of thymic carcinoma (Press release, Alphamab, MAR 9, 2021, View Source [SID1234576358]).

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Thymic carcinoma is a rare but highly aggressive thymic tumor, and the most aggressive subtype of thymic epithelial tumors, accounting for about 20%. The number of patients with thymic carcinoma is about 4,200 to 6,000 in China per year, and 1,400 to 2,000 in the United States per year. Inoperable or metastatic thymic carcinoma has a very poor prognosis, and there is currently no approved standard treatment for patients who have failed platinum-based chemotherapy. The median overall survival after late-line chemotherapy or targeted therapy is less than 12 months, and there is an urgent need for better options to improve the efficacy.

KN046 is a bispecific antibody targeting PD-L1 and CTLA-4 immune checkpoints. It can more effectively activate T-cells and enhance the T-cells cancer killing ability. In a phase I clinical study conducted in Australia, KN046 showed a 75% disease response rate and 100% disease control rate in patients with thymic epithelial tumors. The research data was presented at the 21st World Conference on Lung Cancer (WCLC 2020). In September 2020, KN046 was granted the orphan drug designation by the FDA for the treatment of thymic epithelial tumors. In January 2021, the Phase II pivotal clinical trial of KN046 for the treatment of thymic carcinoma (clinical trial No.: ENREACH-Thymic) completed enrollment of the first patient in China.

About KN046
KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a different mechanism CTLA-4 fused with PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg (suppress tumor immunity) clearing function.

There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, TNBC, ESCC, HCC and pancreatic cancer in Australia and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab has received FDA clearance to enter phase Ⅱ trial of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA’s orphan drug designation for thymic epithelial tumor in September 2020. Two pivotal clinical trials are currently being conducted.