Innate Pharma Reports Third Quarter 2020 Financial Results and Business Update

On November 17, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported its revenues and cash position for the first nine months of 2020 (Press release, Innate Pharma, NOV 17, 2020, View Source [SID1234571205]).

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"In November, we were very pleased that our lead proprietary asset, lacutamab, was awarded PRIME designation in Sézary Syndrome by the European Medicines Agency, which follows the US Fast Track designation by the FDA last year. Lacutamab is an important part of our strategy to build a focused proprietary pipeline, and these regulatory milestones further validate the unmet need in this patient population," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "In addition, the Phase 3 monalizumab clinical trial recently initiated by AstraZeneca is an important achievement for the Company, as it both validates our scientific approach while fortifying our cash position until the end of 2022. Collectively, these milestones are strong proof points in executing on our strategy and accelerating our efforts to deliver meaningful medicines to patients."

Third quarter 2020 and post-period events:

Lacutamab (IPH4102, anti-KIR3DL2 antibody):

The Company recently announced that the European Medicines Agency (EMA) has granted PRIME designation to lacutamab for the treatment of patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies.
The TELLOMAK Phase 2 clinical trial, which is evaluating the efficacy and safety of lacutamab in patients with advanced cutaneous T-cell lymphomas, is now fully open to enrollment.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

As recently announced, AstraZeneca has dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors. Dosing of the first patient in this trial, which occurred in October 2020, has triggered a $50 million milestone upcoming payment from AstraZeneca to Innate. Upon this milestone payment, the Company will have received a total of $400 million to date from the AstraZeneca partnership.
Updated data from the IPH2201-203 Phase 2 trial regarding patients previously treated with a platinum-based chemotherapy and a PD(L)1 inhibitor will be presented via an e-poster at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Virtual Congress in December 2020.
Avdoralimab in Inflammation (IPH5401, anti-C5aR antibody):

The first patient has been dosed in the investigator-sponsored Phase 2 clinical trial in bullous pemphigoid (BP) where the C5aR1 pathway has been shown to be involved in the physiopathology of the disease. The trial is investigating the clinical efficacy of avdoralimab in addition to topical steroids compared to topical steroids alone in BP patients. More information on this study can be found at clinical trials.gov.
Avdoralimab in COVID-19:

The investigator-sponsored Phase 2 clinical trial, FORCE (FOR COVID-19 Elimination), is ongoing. A third cohort was recently added to the trial, which is addressing COVID-19 related Acute Respiratory Distress Syndrome (ARDS) patients requiring mechanical ventilation. More information on this study can be found at clinical trials.gov.
The investigator-sponsored Phase 2 clinical trial, ImmunoONCOVID-20, has resumed. This study is exploring the potential efficacy of monalizumab and avdoralimab amongst other treatment arms, against COVID-19 in cancer patients with mild symptoms and pneumonia respectively.
Lumoxiti, a first-in-class marketed product for the treatment of relapsed or refractory hairy cell leukemia:

The global COVID-19 pandemic and slower adoption rate continues to impact the sales of Lumoxiti in 2020.
As previously stated, following completion of the transition of US Lumoxiti commercial operations from AstraZeneca, sales will be fully booked by Innate beginning in Q4 2020.
The Lumoxiti EU regulatory decision remains on track for 1H 2021.
Financial results:

Cash, cash equivalents and financial assets of the Company amounted to €163.6 million as of September 30, 2020. As it is a post closing event, the $50 million milestone upcoming payment for the first patient dosed in the Interlink-1 Phase 3 study of monalizumab are not included in those figures. Financial liabilities amounted to €19.8 million.

For the nine-month periods ended September 30, 2019 and 2020, revenue from collaboration and licensing agreements mainly results from the spreading of the initial payments received under our agreements with AstraZeneca. Due to accounting rules and the timing of costs related to development activities under the collaboration with AstraZeneca, the recognition of this revenue can vary on a quarter by quarter each year. As a reminder, this has no impact on cash. Revenues for the first nine-months of 2020 amounted to €33.6 million, compared to €65.4 million for the same period in 2019.

Oxford Drug Design welcome new CEO Dr. Alan D. Roth

On November 17, 2020 Oxford Drug Design Board of Directors reported the appointment of Dr. Alan D. Roth Chief Executive Officer, effective immediately (Press release, Oxford Drug Design, NOV 17, 2020, View Source [SID1234571204]).

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Alan takes over the position from Dr. Paul W. Finn, who will remain with the company as Chief Scientific Officer.

Alan’s career in health sciences comprises of executive operations, academic research, investment management/capital markets and strategic consultancy. He started his career at Merck & Co. in New Lead Discovery, before moving into consultancy at McKinsey serving leading companies globally. He was Director at Commerzbank Asset Management in charge of global healthcare investments and industrial investment research. He co-founded, took public and was the first CEO and CFO of Chiral Quest, a life sciences company in the area of chiral pharmaceuticals. He is also currently Director at Fitzroy Partners in London developing new life sciences ventures.

Dr. Finn said, "Oxford Drug Design’s unique combination of computational drug design technology and therapeutic pipeline is progressing rapidly. Alan brings key knowledge and expertise that will be instrumental to the company’s growth and development. I am greatly looking forward to working with Alan to take Oxford Drug Design to the next level".

Dr. Roth said "I am delighted to be joining the team at Oxford Drug Design and look forward to building further on the significant achievements made thus far. In our next stage of development ODD can deliver important impact across selected therapeutic and the related computational areas"

Alan earned his BA (Hons) from Cornell University, PhD in organic chemistry from Columbia University and Postdoctoral Fellowship in medicinal chemistry from the University of Oxford. He is Royal Society Entrepreneur in Residence and Visiting Lecturer at Oxford in science entrepreneurship.

xCures launches xACCESS – A new module in their AI-assisted clinical platform

On November 17, 2020 xCures Inc. reported that it is launching xACCESS – a new registration module for their AI-assisted clinical study platform (Press release, xCures, NOV 17, 2020, View Source [SID1234571196]). The module is used to enroll cancer patients and empower them, and their physicians, to make informed decisions and learn about access to treatment programs. The xCures platform uses a Master Observational Registry to efficiently run a wide variety of oncology studies and decentralized trials, prospectively generating real-world evidence.

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"xACCESS is xCures’ first patient-centric technology module, onboarding patients directly to our sponsored studies and partner programs," stated Mika Newton, xCures’ CEO. "This is an important milestone on our journey to make the cancer treatment ecosystem work better for patients and facilitating access to the best treatment options."

The xACCESS registration module enables rapid scaling by eliminating bottlenecks in eConsenting and acquiring medical records, providing benefits to patients, physicians, partners, payers, sponsors, and investors. The resulting Real-World Evidence (RWE) supports the assessment of safety, efficacy, and utility of investigational and approved cancer therapies.

The xACCESS module will be used for all clinical studies and programs available on the xCures platform, including the recently announced Compassionate Use program for ulixertinib (BVD-523), currently enrolling patients with MAPK pathway aberrant cancer.

Targovax to present at Bryan Garnier & Co Virtual European Healthcare Conference

On November 17, 2020 Targovax ASA, reported that members of the management team will present the company at Bryan Garnier & Co Virtual European Healthcare Conference today, Tuesday 17 November (Press release, Targovax, NOV 17, 2020, View Source [SID1234571195]).

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The presentation will be available to download at www.targovax.com after the event.

Chi-Med Announces US$100 Million Equity Investment by CPP Investments

On November 17, 2020 Hutchison China MediTech Limited ("Chi-Med" or the "Company") (Nasdaq/AIM: HCM) reported that it has entered into a definitive agreement for the sale of US$100 million of shares at a price equivalent to US$30 per American Depositary Share ("ADS") via a private placement to Canada Pension Plan Investment Board ("CPP Investments") (Press release, Hutchison China MediTech, NOV 17, 2020, https://www.chi-med.com/us100-million-equity-investment-by-cpp-investments/ [SID1234571193]).

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Mr. Christian Hogg, Chief Executive Officer of Chi-Med, said, "We are very pleased to welcome CPP Investments as a shareholder. CPP Investments’ focus on building long-term value and its experience in healthcare investing make it an important global strategic partner to Chi-Med. We look forward to building on the partnership as we work, during the next six months, to launch both surufatinib and savolitinib in China, subject to approval, as well as submit our first U.S. NDA on surufatinib."

Mr. Agus Tandiono, Managing Director and Head of Fundamental Equities Asia at CPP Investments, said, "This placement aligns with CPP Investments’ focus on providing strategic, long-term capital to industry leading companies where we can participate in the future success of the business and help create greater value through ongoing partnership. We look forward to supporting Chi-Med’s work on innovation in oncology treatment."

Chi-Med will receive all proceeds from this private placement of the equivalent of 3,333,334 ADSs, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally.

Description of Share Capital and Securities Regulation
Chi-Med has agreed to issue 16,666,670 ordinary shares, par value US$0.10 each (the "Shares"), pursuant to the private placement. The Shares will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing ordinary shares of Chi-Med. Each ADS represents five Shares.

The securities to be sold in the private placement will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Subject to certain conditions, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Shares sold in the private placement to facilitate future resales by CPP Investments. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. CPP Investments has the right to appoint an observer and a representative director to the board of directors of the Company upon achieving certain ownership thresholds in the future.

This announcement, including any information included or incorporated by reference in this announcement, is for information purposes only and shall not constitute nor form part of, and should not be construed as, an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. No public offering of the securities referred to in this announcement is being made in the United States or elsewhere.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

Admission to the London Stock Exchange AIM market and Shares Outstanding After Completion
Application will be made for the Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that Admission will become effective at 8:00 a.m. GMT on November 26, 2020.

Following admission of the Shares to trading on AIM, the issued share capital of Chi-Med will consist of 727,702,215 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. The figure of 727,702,215 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, Chi-Med under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

For illustrative purposes only, if the 727,702,215 ordinary shares were converted in their entirety, they would be equivalent to 145,540,443 Nasdaq-traded ADSs (each equating to five ordinary shares).