On June 30, 2021 McKesson Corporation (NYSE: MCK) reported that it will release its first quarter fiscal 2022 financial results after market close on Wednesday, August 4, 2021 (Press release, McKesson, JUN 30, 2021, View Source [SID1234584518]). The company will host a live webcast of the earnings conference call for investors at 4:30 PM Eastern Time to review its financial results.

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The live webcast will be available on McKesson’s Investor Relations website at View Source, along with the company’s earnings press release, financial tables and slide presentation.

On June 30, 2021 HUTCHMED (China) Limited ("HUTCHMED" or the "Company") (Nasdaq/AIM: HCM) reported the listing of its ordinary shares ("Shares") on the Main Board of the Stock Exchange of Hong Kong Limited (the "SEHK") under the stock code "13" and the closing of its previously-announced primary offering of 104,000,000 new ordinary shares on the SEHK (the "Offer Shares"), which comprises an international offering of 91,000,000 Offer Shares ("International Offering") and a Hong Kong public offering of 13,000,000 Offer Shares (the "Hong Kong Public Offering", and together with the International Offering, the "Global Offering") (Press release, Hutchison China MediTech, JUN 30, 2021, View Source [SID1234586914]).

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The gross proceeds to the Company from the Global Offering, before deducting underwriting fees and the offering expenses, were approximately HK$4.17 billion. In addition, the Company has granted the international underwriters an over-allotment option, exercisable from June 30, 2021 until 30 days after the last day for lodging applications under the Hong Kong Public Offering, to require the Company to issue up to an additional 15,600,000 new Shares at the Offer Price (defined below).

The Company entered into cornerstone investment agreements with investors affiliated with The Carlyle Group, Canada Pension Plan Investment Board, General Atlantic, HBM Healthcare Investments and CICC Grandeur Fund. Pursuant to such agreements, they subscribed for a total of 63,215,500 Offer Shares, representing approximately 61% of the Offer Shares offered under the Global Offering (assuming the over-allotment option is not exercised).

With effect upon the listing of the Shares on the Main Board of the SEHK, the board of directors of the Company has adopted the Hong Kong Corporate Governance Code (as set out in Appendix 14 to the Rules Governing the Listing of Securities on the SEHK), in replacement of the UK Corporate Governance Code (published by the UK Financial Reporting Council on July 15, 2018). The Company’s updated corporate governance statement of compliance is available on the Company’s website at View Source

As announced on June 23, 2021, the final offer price for both the International Offering and the Hong Kong Public Offering (the "Offer Price") had been set at HK$40.10 per Share, which is equivalent to approximately US$25.82 per American depositary share ("ADS") or £3.70 per Share. Each ADS represents five ordinary shares of the Company.

Morgan Stanley Asia Limited, Jefferies Hong Kong Limited and China International Capital Corporation Hong Kong Securities Limited are the joint sponsors for the Global Offering.

Information about the Global Offering
Sales of Shares outside of Hong Kong (other than certain Shares which were sold to investors in reliance on Regulation S or another exemption from the registration requirements of the U.S. Securities Act of 1933) initially offered in the United States and sold outside the United States that may be resold from time to time in the United States were offered pursuant to an automatically effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and final prospectus supplement relating to and describing the terms of the Global Offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. An electronic version of the prospectus supplement and the accompanying prospectus relating to these securities, as filed with the SEC, may be obtained for free by mailing the request to: Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department, or E-mail: [email protected]; Jefferies Hong Kong Limited, Email: [email protected]; and China International Capital Corporation Hong Kong Securities Limited, Email: [email protected].

This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.

Global Offering Use of Proceeds
The net proceeds from the Global Offering to be received by the Company are estimated to be approximately HK$3,950 million (assuming the over-allotment option is not exercised), based on the Offer Price of HK$40.10, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company currently intends to apply such net proceeds for the following purposes:

approximately HK$1,975 million (or approximately 50% of the net proceeds) to advance the Company’s late-stage clinical programs for savolitinib, surufatinib, fruquintinib, HMPL-689 and HMPL-523 through registration trials and potential NDA submissions;
approximately HK$395 million (or approximately 10% of the net proceeds) to support further proof-of-concept studies and fund continued expansion of the Company’s product portfolio in cancer and immunological diseases through internal research, including the development cost of early-clinical and preclinical-stage pipeline drug candidates;
approximately HK$790 million (or approximately 20% of the net proceeds) to further strengthen the Company’s integrated capabilities across commercialization, clinical and regulatory and manufacturing;
approximately HK$593 million (or approximately 15% of the net proceeds) to fund potential global business development and strategic acquisition opportunities to complement the Company’s internal research and development activities; and
approximately HK$197 million (or approximately 5% of the net proceeds) for working capital, expanding internal capabilities globally and in China, and general corporate purposes.

On June 30, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, reported dose administration for the first patient in the Phase 1, multicenter, open-label, first-in-human study of DCC-3116 (Press release, Deciphera Pharmaceuticals, JUN 30, 2021, View Source [SID1234584503]). DCC-3116 is an investigational ULK kinase inhibitor designed to inhibit autophagy and is being studied as a single agent and in combination with trametinib, a U.S. Food and Drug Administration (FDA) approved MEK inhibitor, in patients with advanced or metastatic tumors with a mutant RAS or RAF gene.

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"Approximately one third of all cancers, including a high percentage of pancreatic, lung, colorectal, and melanoma cancers, are driven by mutations in RAS or RAF genes, representing what we believe to be one of the largest unmet medical needs in oncology," said Matthew L. Sherman, MD, Executive Vice President and Chief Medical Officer of Deciphera Pharmaceuticals. "DCC-3116, a first-in-class, highly selective switch-control ULK kinase inhibitor, is designed to suppress autophagy and may offer a novel approach to targeting a broad array of cancers. We look forward to advancing our fourth active clinical development program generated from our switch-control kinase inhibitor platform and further evaluating the role of ULK kinase inhibition and its potential to represent a new treatment paradigm for cancers caused by RAS or RAF mutations."

Autophagy, a catabolic process in which cells recycle components to generate energy, is often upregulated in cancer cells when cells are stressed or damaged due to anti-cancer treatments. The ULK kinase initiates the autophagy pathway and provides a potential targeted approach to selectively inhibiting autophagy in cancers caused by RAS or RAF mutations. In preclinical studies, DCC-3116 was observed to potently and durably inhibit autophagy in RAS and RAF mutant cancer cell lines through the inhibition of ULK kinase. In addition, in preclinical studies, DCC-3116 also blocked the increase in autophagy induced by inhibitors of the MAPK pathway as a resistance mechanism. The Company’s in vitro and in vivo studies have demonstrated that DCC-3116 in combination with inhibitors of the MAPK pathway may block the growth of cancers caused by RAS or RAF mutations.

The clinical development plan for DCC-3116 will focus on documented RAS and RAF cancer mutations, which utilize autophagy for tumor growth and survival. The Phase 1, multicenter, open-label, first-in-human study will evaluate DCC-3116 as a single agent and in combination with trametinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic tumors with a mutant RAS or RAF gene. Assuming positive results in the dose escalation phase, combination expansion cohorts are currently planned in patients with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS or BRAF mutations, non-small cell lung cancer (NSCLC) with KRAS, NRAS, or BRAF mutations, colorectal cancer (CRC) with KRAS, NRAS, or BRAF mutations, and melanoma with NRAS or BRAF mutations. Combination expansion cohorts are planned to evaluate DCC-3116 in combination with trametinib.

On June 30, 2021 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the initiation of a new phase I study evaluating NBTXR3 activated by radiation therapy (RT) for patients with non-small cell lung cancer (NSCLC) amenable to re-irradiation (Press release, Nanobiotix, JUN 30, 2021, View Source [SID1234584519]). The phase I is among five collaborator-led studies that are active and recruiting at The University of Texas MD Anderson Cancer Center (MD Anderson), and the third to enroll its first patient.

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"Our ongoing collaboration with MD Anderson remains a critical component of our strategy as we seek to develop NBTXR3 as a solid tumor-agnostic, therapeutic combination-agnostic agent with the potential to change the practice of radiotherapy and immunotherapy," said Laurent Levy, co-founder and chief executive officer of Nanobiotix. "These collaborator-led studies not only provide patients with significant unmet need the opportunity to benefit from MD Anderson’s physicians, but also provide additional capacity for Nanobiotix to expand development of NBTXR3 into indications where innovation is urgently needed while remaining focused internally on our priority pathways in head and neck cancer and immunotherapy."

A Phase I Study of Reirradiation with NBTXR3 for Inoperable Locoregional Recurrent Non-Small Cell Lung Cancer

This phase I study, led by Saumil Gandhi, Assistant Professor, Department of Radiation Oncology, Division of Radiation Oncology, MD Anderson, investigates the safety and optimal dose of NBTXR3 when activated by radiation therapy for the treatment of non-small cell lung cancer that cannot be treated by surgery (inoperable) and has come back (recurrent). The study has a two-cohort, open label design consisting of two parts: (i) RT safety lead-in cohort recruiting up to 10 patients and NBTXR3 activated by RT dose-finding cohort recruiting up to 12 patients; and (ii) expansion at the recommended phase II dose (RP2D) with toxicity monitoring recruiting 12 patients. The dose levels explored to be explored are 22% and 33% of baseline gross tumor volume. The planned enrollment period is up to three years.

The patient population includes adults (age ≥ 18 years) with medically inoperable NSCLC with overlap between recurrent disease in need of treatment and prior RT. Given the design of the study, patients in the first cohort in part one will receive RT and be monitored for safety before the second cohort is opened where patients will receive injections of NBTXR3.

Five Studies Now Active and Recruiting in Clinical Collaboration

In addition to the lung cancer study described above, two phase II studies, each evaluating NBTXR3 in combination with anti-PD-1 for patients with head and neck cancer (inoperable locoregional recurrent amenable to reirradiation and recurrent metastatic with limited PD-L1 expression or refractory); one phase I study evaluating NBTXR3 in combination with chemotherapy for patients with esophageal cancer; and one phase I study evaluating NBTXR3 as a single-agent activated by RT for patients with pancreatic cancer are active and enrolling. As previously announced, the first patient has been injected with NBTXR3 in each of the esophageal cancer and pancreatic cancer studies. The first NBTXR3 injections in the phase II head and neck cancer studies are expected in the second half of 2021. All studies in the collaboration are led by MD Anderson and milestones will be reported as they are made available by the institution.

Next Steps for Collaborator-led Expansion of NBTXR3 Development as a Potentially Solid Tumor-Agnostic and Therapeutic Combination-Agnostic Agent

The clinical collaboration between Nanobiotix and MD Anderson is a collaborator-led expansion of the NBTXR3 development pipeline across indications and therapeutic combinations. One additional study evaluating NBTXR3 in combination with anti-CTLA-4 and anti-PD-1/L1 plus RadScopal in advanced solid tumors with lung or liver metastasis is planned to launch in the second half of 2021. Further studies evaluating the potential of NBTXR3 to address unmet needs throughout the oncology landscape are in discussion as part of the collaboration agreement and updates will be provided as the planning process evolves.

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 physical 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 physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly 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; and a phase III global registrational study is planned to launch in the second half of 2021. 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—the same population being evaluated in the planned phase III study.

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 lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners 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.

On June 30, 2021 Dr. Reddy’s Laboratories Limited (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported that its Annual Report on Form 20-F containing its consolidated financial statements for the fiscal year ended March 31, 2021 and prepared in accordance with the International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board was filed with the United States Securities and Exchange Commission (SEC) on June 30, 2021 (Press release, Dr Reddy’s, JUN 30, 2021, View Source [SID1234584520]).

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The Annual Report on Form 20-F is also available on the website of Dr. Reddy’s, www.drreddys.com. American Depositary Receipts (ADRs) holders may also obtain a hard copy of the Annual Report on Form 20-F at no cost, by sending a written request to the Company’s registered office or by sending an e-mail to [email protected].