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.

On November 17, 2020 Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare and other high-burden diseases, reported it will participate in fireside chats at two investor conferences in December 2020 (Press release, Aeglea BioTherapeutics, NOV 17, 2020, View Source [SID1234571256]).

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Conference Details

Conference Name: Piper Sandler 32nd Annual Virtual Healthcare Conference
Conference Date: November 30 – December 3, 2020
Fireside Chat Date/Time: Available beginning November 23, 2020
Presenter: Anthony G. Quinn, M.B. Ch.B., Ph.D., Aeglea’s president and chief executive officer

Conference Name: Evercore ISI 3rd Annual HealthCONx Conference
Conference Date: December 1-3, 2020
Fireside Chat Date/Time: December 1, 2020 at 4:20 p.m. EST
Presenter: Anthony G. Quinn, M.B. Ch.B., Ph.D., Aeglea’s president and chief executive officer

To access the live and archived webcasts, visit the Presentations & Events section of the Company’s website. Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary. An archived version of the webcasts will also be available through the Company’s website for a limited time following the conferences.

On November 17, 2020 PierianDx, the leading clinical genomics informatics company, and Bench International, a leading global executive search firm, reported the appointment of Mark McDonough as Chief Executive Officer (CEO) and member of the Board of Directors of PierianDx, effective immediately (Press release, PierianDx, NOV 17, 2020, View Source [SID1234571286]). In his new role, McDonough will help fulfill the company’s unique value proposition of enabling precision medicine through its best-in-class variant interpretation knowledgebase, integrated infrastructure, and clinical genomics reporting for both cancer and inherited disease. McDonough succeeds Chairman of the Board and Interim CEO, Joe Boorady, who remains as Chairman of the PierianDx Board of Directors.

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"Mark commands a deep understanding of the diagnostics market, and we are delighted to welcome him to the PierianDx family during this exciting time in the company’s development," said Joe Boorady. "Mark will drive company execution on its IVD strategy and solidify its leadership position in the global cancer and hereditary disease diagnostics market."

Mark McDonough is a global technology business executive with nearly 30 years of experience. His personal mission is to impact change in the field of healthcare in a compassionate yet resolute manner, leading by example. He most recently served as CEO and board member for Immunis.AI, where he secured funding and developed a top flight team within six months to launch a novel noninvasive liquid biopsy immunogenomics assay for prostate cancer patients on ‘active surveillance.’ Prior to this, McDonough served as President, CEO and board member of CombiMatrix from 2012 through 2018, orchestrating its sale to Invitae in November 2017. Under his leadership, CombiMatrix experienced 14 consecutive quarters of record growth. Earlier in his career, he served in various sales leadership roles within the clinical laboratory industry and developed his leadership skills as a Navigator and Communications Officer in the US Navy.

"An established, respected and trusted leader in the genomics industry, Mark is the perfect CEO for PierianDx," said DeeDee DeMan, Chairman and CEO of Bench International. "He has a remarkable track record of developing teams, fundraising, and directing corporate strategy and growth."

"I am excited to join PierianDx and lead this talented team committed to delivering tools to our partners and customers that enable precision medicine adoption at scale," said Mark McDonough. "We believe advanced genomic testing should be democratized and available to all at the highest quality and lowest cost. I look forward to helping propel the company as we expand our market leadership and serve more patients through our partners and customers."

On November 17, 2020 OncoSynergy, a patient-focused biotech startup founded by physicians trained in neurosurgery reported that it has opened enrollment in their phase 1 trial which will study OS2966, a novel therapeutic antibody, for treatment of glioblastoma (Press release, OncoSynergy, NOV 17, 2020, View Source [SID1234571311]). The trial will take place at Moffitt Cancer Center in Tampa, Florida under the leadership of Michael Vogelbaum, MD, PhD.

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OS2966 inhibits Beta1 integrin (CD29), a critical receptor responsible for integrating cancer promoting signals and driving cancer growth and spread. Studies have demonstrated that resistance to anti-angiogenic therapy (i.e., bevacizumab) is associated with increased expression of Beta1 integrin. OncoSynergy studied OS2966 in animal models implanted with patient tumor samples that had become resistant to treatment with bevacizumab. These studies revealed that OS2966 prevented the ability of bevacizumab-resistant tumor cells to invade the surrounding brain and resulted in significant tumor cell death (Carbonell et al, 2013).

Despite advancement of several new promising cancer treatments, successful treatment of glioblastoma has been limited by the presence of the brain’s protective blood brain barrier and the invasive nature of glioblastoma. To combat these obstacles, a technique called convection-enhanced delivery (CED) will be utilized to deliver OS2966 directly to the brain tumor and surrounding tumor-infiltrated brain.

The primary goal of this phase 1 study is to determine the safety and tolerability of OS2966 when delivered directly to the brain. That said, given pre-clinical data demonstrating OS2966’s ability to address therapy resistant tumors and a delivery technique designed to overcome obstacles specific to glioblastoma, the ultimate hope is to improve outcomes for patients suffering from this formidable disease.

On November 17, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 6,451,613 shares of common stock of the Company, at a price to the public of $3.10 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, NOV 17, 2020, View Source [SID1234571347]). The closing of the offering is expected to occur on or about November 20, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 967,741 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional common stock, are expected to be approximately $20.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.