On November 16, 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 16, 2020, View Source [SID1234571194]).

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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 16, 2020 Alligator Bioscience ("Alligator") (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy and Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ:APVO), a biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR bispecific technology platform, reported an update on ALG.APV-527, a novel immunotherapeutic bispecific candidate intended for the treatment of multiple solid tumors expressing 5T4, a tumor-restricted antigen (Press release, Alligator Bioscience, NOV 16, 2020, View Source [SID1234571191]).

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Aptevo and Alligator are advancing ALG.APV-527 into Phase I clinical development in a co-development 50/50 partnership. The companies anticipate filing a Clinical Trial Authorization during the first half of 2021 to initiate Phase I clinical development in multiple sites in the European Union. Aptevo and Alligator will continue to explore licensing opportunities as ALG.APV-527 moves into clinical development.

"We are very excited about taking ALG.APV-527 into the clinic now, as recent APVO436 complete remission data in two patients in cohort 6 of that Phase I clinical trial speaks to the potential of our ADAPTIR platform. As a potential first-in-class molecule, ALG.APV-527 showcases the versatility of our ADAPTIR platform in generating bispecific antibodies with unique mechanisms of action and a therapeutic profile that is more consistent with traditional antibodies, including an extended half-life, desirable antibody-like manufacturing characteristics and optimized for potency and stability," said Mr. Marvin White, President and CEO of Aptevo.

"Our collaboration with Alligator Bioscience continues to yield encouraging data supporting the potential advantages of this novel pathway for targeted immunotherapy of cancer. For these reasons, and given recent improvements in our financial position, we are excited to advance this asset into the clinic with the desire to enable potential additional value creation for shareholders as we develop the asset," concluded Mr. White.

"Aptevo’s clinical candidate APVO436 is based on the same ADAPTIR platform as ALG.APV-527. It is my belief that the response data observed in the APVO436 Phase I trial validates the bispecific format of ALG.APV-527, and strengthens our view that it has the potential to become a successful cancer therapy," said Per Norlén, CEO of Alligator Bioscience.

ALG.APV-527 is designed to simultaneously target 5T4 and the co-stimulatory receptor 4-1BB (CD137) to promote potent, tumor-directed immune T-cell activation. 5T4 is a well-defined tumor antigen expressed on many different types of malignancies including non-small cell lung, renal, pancreatic, prostate, breast, colorectal, gastric, ovarian and cervical cancers and mesothelioma. Conversely, 5T4 has limited expression on adult normal tissues, making it an attractive target for cancer immunotherapy.

Presentation at the SITC (Free SITC Whitepaper) 35th Annual Meeting

As announced on Monday, November 9, Aptevo is presenting two new posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Virtual Annual Meeting, including one on ALG.APV-527. The poster will present preclinical data demonstrating that ALG.APV-527 has a potentially favorable safety profile with no indication of systemic immune activation or liver toxicity in NHP or murine models. ALG.APV-527 induces robust in vitro killing of tumors that is dependent on 5T4 engagement. In vivo, ALG.APV-527 augmented anti-tumor responses and promoted tumor-specific memory.

Details of the Poster Presentation are as follows:

ALG.APV-527: Potent tumor-directed T cell activation and in vivo tumor inhibition induced by a 4-1BB x 5T4 ADAPTIR bispecific antibody

The abstracts and the accompanying posters will be available in the Virtual Poster Hall to registered attendees from 8:00 am EST on Monday, November 9, until the Virtual Poster Hall closes on December 31, 2020 on the SITC (Free SITC Whitepaper) abstract website

About ALG.APV-527

ALG.APV-527 is a novel immunotherapeutic bispecific candidate intended for the treatment of multiple solid tumors expressing 5T4, a tumor-restricted antigen. 5T4 is an antigen that is highly expressed in a large percentage of solid tumors, including, non-small cell lung cancer (NSCLC), head and neck cancer and mesothelioma. ALG.APV-527 is designed to activate anti-tumor responses by inducing signaling through the co-stimulatory receptor 4-1BB (CD137), which is an immune receptor that is upregulated on activated T cells and natural killer (NK) cells.

On November 16, 2020 Nordic Nanovector ASA (OSE: NANO)reported that it will report its results for the third quarter 2020 on Thursday, 19 November 2020 (Press release, Nordic Nanovector, NOV 16, 2020, View Source [SID1234571185]).

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A presentation by Nordic Nanovector’s senior management team will be webcast live the same day at 8:30am CET.

The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2020 from 7:00am CET the same day.

On November 16, 2020 Nordic Nanovector ASA (OSE: NANO) reported that its Interim CEO, Dr Lars Nieba will present a corporate overview, via live webcast, and host one-on-one meetings with investors at the Jefferies Virtual London Healthcare Conference, taking place 17-19 November 2020 (Press release, Nordic Nanovector, NOV 16, 2020, View Source [SID1234571184]).

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Presentations details are as follows:

Jefferies Virtual London Healthcare Conference
Date: Thursday, 19 November 2020
Time: 2:40 to 3:10PM (GMT)

The company presentation will be available on Nordic Nanovector’s Investors and Media page at the same time.

On November 16, 2020 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX: NRI) (OTCQX: NRIFF), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three and nine months ended September 30, 2020 (Press release, Nuvo Pharmaceuticals, NOV 16, 2020, View Source [SID1234571183]). For further details on the results, please refer to Nuvo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements for the three and nine months ended September 30, 2020 which are available on the Company’s website (www.nuvopharmaceuticals.com). All figures are in Canadian dollars, unless otherwise noted.

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Key Developments
Three months ended September 30, 2020 include the following:

Adjusted total revenue(1) was $16.7 million, a decrease of 12% compared to $18.9 million for the three months ended September 30, 2019.

Adjusted EBITDA(1) was $6.6 million, a decrease of 15% compared to $7.8 million for the three months ended September 30, 2019.

The Company’s Commercial Business segment includes the promoted products – Blexten and Cambia . Revenue related to these products was $6.4 million, an increase of 21% compared to revenue of $5.3 million for the three months ended September 30, 2019. Canadian prescriptions of Blexten and Cambia increased by 30% and 13%, respectively compared to the three months ended September 30, 2019.

Principal loan repayments of $3.7 million (US$2.8 million).
Nine months ended September 30, 2020 include the following:

Adjusted total revenue(1) was $53.6 million, a decrease of 3% compared to $55.1 million for the nine months ended September 30, 2019.

Adjusted EBITDA(1) was $22.2 million, an increase of 19% compared to $18.7 million for the nine months ended September 30, 2019.

Revenue related to Blexten and Cambia was $18.7 million, an increase of 34% compared to revenue of $13.9 million for the nine months ended September 30, 2019. Canadian prescriptions of Blexten and Cambia increased by 37% and 13%, respectively compared to the nine months ended September 30, 2019.

Principal loan repayments of $18.8 million (US$14.0 million).
(1)

Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Business Update

As a result of the COVID-19 pandemic, the Company has made changes to operations to ensure our employees are safe and healthy, while the business continues to supply global partners, wholesalers, pharmacies, and ultimately patients, with our healthcare products. The Commercial Business segment had continued organic growth of its key promoted products – Blexten and Cambia. The possibility of future supply disruptions resulted in forward buying linked to the COVID-19 pandemic which increased revenue in the three months ended March 31, 2020 and reduced revenue in the three months ended June 30, 2020 as the pandemic progressed. Buying patterns stabilized in the three months ended September 30, 2020. It is anticipated that the COVID-19 pandemic may continue to impact the timing of revenue in future quarters and the Company will monitor market dynamics accordingly.

In September 2020, Aralez Pharmaceuticals Canada, Inc. (Aralez Canada) received notice that Health Canada had issued a medical device license for two new line extensions of NeoVisc. NeoVisc is a viscosupplement used to replenish the synovial fluid in the joints of patients with osteoarthritis. NeoVisc One contains the lowest injection volume (only 4ml) available for single-dose viscosupplements in Canada. Neovisc Plus consists of a three injection dosing system that is administered to a patient over the course of a few weeks. In some patients, a three dose treatment may provide longer relief.

In September 2020, Aralez Canada launched Suvexx into the approximately $130 million Canadian prescription acute migraine market. Suvexx (sumatriptan succinate and naproxen sodium tablets) is a fixed-dose combination prescription medication, indicated for the acute treatment of migraine attacks with or without aura in adults. Suvexx helps patients manage acute migraine attacks using a combination of sumatriptan succinate and naproxen sodium in a single tablet.

In August 2020, the Blexten pediatric dossier was accepted for review by Health Canada. If approved, Blexten pediatric will be available in both an oral syrup formulation (2.5mg/ml) and an orally dispersible tablet formulation (10mg tablets). A regulatory decision from Health Canada is anticipated by mid-2021.

During the three months ended September 30, 2020, the Company made a $3.7 million (US$2.8 million) principal repayment on the Amortization Loan, included within the loans held by Deerfield Management Company, L.P and its related entities (the Deerfield Loans). Since January 1, 2020, the Company has repaid $18.8 million (US$14.0 million) of the Deerfield Loans – $4.5 million (US$3.5 million) to discharge the Bridge Loan which bore interest at 12.5% and $14.2 million (US$10.5 million) against the Amortization Loan which bears interest at 3.5%. As of September 30, 2020, the total remaining balances of the Deerfield Loans consisted of: US$49.5 million on the Amortization Loan and US$52.5 million on the Convertible Loan both of which bear interest at 3.5%.
"In September, we launched our innovative treatment for acute migraine attacks, Suvexx, into the Canadian market. Thus far, the Suvexx launch has been well received with encouraging feedback from physicians and patients who now have access to this new medicine. Despite the COVID-19 pandemic, our key promoted products, Blexten and Cambia, have continued to grow both in terms of total prescriptions and market share versus 2019. The loss of the guaranteed minimum royalty for Vimovo in the U.S. has negatively impacted our top-line sales revenue; however, the restructuring we implemented in Q2 2019 has helped to improve both our adjusted EBITDA and cash from operating activities during the quarter and year-to-date," said Jesse Ledger, Nuvo’s President & CEO. "In Q3, we made continued progress in repaying our debt to Deerfield and have now repaid over $18 million year-to-date. We continue to meet our growth strategy objectives and look forward to a strong finish to the year."

Third Quarter 2020 Financial Results
Total revenue is comprised of product sales, license revenue and contract revenue. Total revenue was $16.6 million and $56.5 million for the three and nine months ended September 30, 2020 compared to $18.8 million and $50.0 million for the three and nine months ended September 30, 2019.

Adjusted total revenue was $16.7 million and $53.6 million for the three and nine months ended September 30, 2020 compared to $18.9 million and $55.1 million for the three and nine months ended September 30, 2019. The $2.2 million decrease in adjusted total revenue in the current quarter was primarily attributable to a decrease of $1.6 million of revenue in the Licensing and Royalty Business segment, combined with a decrease of $0.4 million of revenue in the Production and Service Business segment and a $0.1 million decrease in revenue from the Commercial Business segment. The Commercial Business segment revenue had continued organic growth of its key promoted products – Blexten and Cambia. The possibility of future supply disruptions resulted in forward buying linked to the COVID-19 pandemic which increased revenue in the three months ended March 31, 2020 and reduced revenue in the three months ended June 30, 2020 and stabilized in the three months ended September 30, 2020 as the pandemic progressed and buying patterns returned to normal. The COVID-19 pandemic may impact the timing of revenue in future quarters and the Company will continue to monitor market dynamics accordingly. For the three months ended September 30, 2020, the Licensing and Royalty Business segment revenue decreased primarily due to a reduction in both U.S. and rest of world net sales of Vimovo. The Production and Service Business segment revenue decreased as a result of a decrease in the Company’s Pennsaid product sales.

Adjusted EBITDA was $6.6 million and $22.2 million for the three and nine months ended September 30, 2020 compared to $7.8 million and $18.7 million for the three and nine months ended September 30, 2019. The decrease in the current quarter was primarily attributable to the decrease in gross profit of $2.4 (net of revenue recognized upon recognition of contract assets, amounts billed to customers for existing contract assets and inventory-step up expenses, partially offset by a decrease in general and administrative (G&A) expenses (net of amortization). This decline in gross profit was due to a decrease in adjusted total revenue, partially offset by an increase in gross margin percentage on product sales due to the receipt of the Canada Emergency Wage Subsidy, as well as changes in product mix.

Gross profit on total revenue was $10.2 million or 61% and $39.1 million or 69% for the three and nine months ended September 30, 2020 compared to a gross profit of $11.3 million or 60% and $30.0 million or 60% for the three and nine months ended September 30, 2019. The decrease in gross profit for the current three was primarily attributable to a decrease in license revenue, partially offset by an increase in gross margin on product sales (See Total Revenue above). The increase in gross profit for the current nine-month period was primarily attributable to an increase in license revenue and gross margin on product sales (See Total Revenue above).

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue, adjusted EBITDA and adjusted EBITDA per share) that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance and in interpreting the effect of the Aralez Transaction and the Deerfield Financing on the Company. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.