On October 16, 2019 Nicox S.A. (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported a Q3 2019 business update and financial highlights, revenue and cash position for Nicox and its subsidiaries (the "Nicox Group"), as well as key upcoming milestones (Press release, NicOx, OCT 16, 2019, View Source [SID1234542293]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Michele Garufi, Chairman and Chief Executive Officer of Nicox, said, "The encouraging topline results from the Dolomites Phase 2 clinical trial of NCX 470 confirm the potential of both this product candidate and of our research platform, and set the stage for the next phase of Nicox’s development. Together with the NCX 4251 blepharitis trial, results of which we expect later in the fourth quarter, Nicox would have two advanced clinical programs in 2020."

Key Upcoming Milestone
NCX 4251 Phase 2 results: Clinical trial in patients with acute exacerbations of blepharitis continuing on track for topline data in Q4 of this year.
NCX 470 Phase 3: End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) expected in early 2020.
Third Quarter 2019 Business update
Nicox announced positive topline results of the Dolomites trial, its multicenter, U.S. Phase 2 safety and efficacy clinical study evaluating NCX 470, a novel second generation nitric oxide (NO)-donating bimatoprost analog, in patients with open-angle glaucoma or ocular hypertension. The 0.065% dose of NCX 470 demonstrated non-inferiority and statistical superiority to latanoprost 0.005%, the U.S. market leader in prostaglandin analog prescriptions.
The total number of prescriptions1 for VYZULTA in the U.S. exceeded 3,000 per week for the first time, with scripts in the third quarter of 2019 increasing by 10% compared to second quarter 2019 and by 127% compared to third quarter 2018.
Nicox amended its bond financing agreement with Kreos Capital and drew down €4 million in additional debt. Under the amended agreement, Nicox may draw down a further €3 million or €8 million on December 31, 2019 subject to notice to Kreos prior to December 16, 2019. Apart from the amended notice dates, payment dates and amounts mentioned here, all other contractual terms remain unchanged.
Nicox entered into an exclusive license agreement with Ocumension Therapeutics for the development and commercialization of NCX 4251, a novel, patented ophthalmic suspension of fluticasone propionate nanocrystals, in the Chinese market and received a €2.0 million upfront payment in July 2019.
In July 2019 we received a $3.0 million milestone payment from U.S. partner Eyevance Pharmaceuticals linked to completion by Nicox of regulatory and manufacturing responsibilities concerning ZERVIATE (cetirizine ophthalmic solution), 0.24% in the U.S. From now on, all manufacturing and regulatory responsibilities, together with decisions on launch timing, lie with Eyevance. Eyevance has informed Nicox that the commercial launch of ZERVIATE in the U.S. is currently projected in the first half of 2020.
We strengthened our Management in CMC Development by appointing Dr. Ramesh Krishnamoorthy, Ph.D., to the newly-created position of Senior Director and Head, Late Stage CMC and Quality Control, effective September 1, 2019. Dr. Krishnamoorthy brings to Nicox over 24 years of experience in CMC, pharmaceutical development, and quality control aspects of sterile ophthalmic products. Dr. Krishnamoorthy holds an M.S. degree in pharmaceutics and Ph.D. in industrial and physical pharmacy.
Third Quarter 2019 Financial Highlights
As of September 30, 2019, the Nicox Group had cash and cash equivalents of €17.4 million, as compared with €17.3 million at June 30, 2019 and €22.1 million at end December 31, 2018. Including the cash from the recent bond financing and the research tax credit payments related to years 2017 and 2018 received in October, the cash available is €22.6 million. Net revenue2 for the third quarter of 2019 was €0.5 million versus €0.4 million in the third quarter of 2018.

As of September 30, 2019, the Nicox Group had financial debt of €7.4 million in the form of a bond financing agreement with Kreos Capital signed in January 2019.

Only figures at 31 December 2018 are audited. All figures of this press release are non-audited.
Notes
1. Bloomberg data, comparing the period of the weeks ending 5 July 2019 to 27 September 2019 with the periods of the weeks ending 5 April 2019 to 28 June 2019 and 6 July 2018 to 28 September 2018
2. Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit in the consolidated statements of profit or loss

On October 16, 2019 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the enrollment and first treatment of a patient with newly diagnosed brain cancer in a phase 1/2 clinical trial (Press release, NOXXON, OCT 16, 2019, View Source [SID1234542276]). The study investigates a combined therapy of increasing doses of the CXCL12 inhibitor, NOX-A12, and external-beam radiotherapy. Within this study, NOX-A12 administration in planned for up to six months. The anticipated mode of action of NOX-A12 is the inhibition of the unwanted influx of bone marrow-derived "repair cells" to the tumor following radiotherapy-induced breakdown of the vasculature in the tumor. These "repair cells" act by replacing the tumor’s blood vessels that were destroyed by the irradiation, which ultimately results in disease recurrence.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study is designed to deliver safety and first efficacy data to support the definition of a Recommended Phase 2 Dose (RP2D) for this new treatment approach. In addition, the noninvasive assessment of the changes in tumor vascularization is expected to confirm the predicted mechanism of action for the combination of NOX-A12 and radiotherapy.

"The trial represents a new option for very difficult-to-treat patients. The candidate drug should block the influx of two distinct types of cells that the damaged brain tumor tries to recruit to help repair itself and survive. A plethora of pre-clinical studies as well as a recent clinical trial at Stanford yielded promising results with interventions targeting the CXCL12 pathway. We learnt some lessons from these data, and we are very optimistic that blocking both cell types for a longer duration will be even more effective," commented Dr. Frank Giordano, Interim Director of the Department of Radiation Oncology at the University Medical Center Mannheim.

"Based on promising preclinical data in rat and mouse models, we are excited to evaluate NOX-A12 in this indication. It is a unique and promising approach with the potential to effectively treat brain cancer patients for whom there are currently no optimal therapies. The demand from the clinical community to test this combination has been very strong and we are pleased that the dosing of patients has been initiated. We expect data from the first cohort of patients to be available in mid-2020," added Dr. Jarl Ulf Jungnelius, Chief Medical Officer of NOXXON.

The trial is being conducted at three hospitals in Germany. Up to three escalating doses of NOX-A12 will be administered in combination with standard radiotherapy as a first line treatment to newly diagnosed patients with brain tumors who would not benefit from the current standard of care of chemotherapy and whose tumors cannot be fully resected by surgery. The main objective of the study is to assess the safety and tolerability of this combination. Secondary endpoints include activity of the therapy, assessed through the monitoring of tumor vascularization by MRI scans, progression-free survival, overall survival and rates of response.

On October 15, 2019 SQZ Biotechnologies (SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, reported the expansion of its collaboration with Roche (SIX: RO, ROG;OTCQX: RHHBY) in cellular therapy (Press release, SQZ Biotech, OCT 15, 2019, View Source [SID1234553406]). The expanded partnership furthers the synergistic combination of SQZ’s innovation and expertise in cell therapy with Roche’s cancer immunotherapy expertise. Under the terms, SQZ and Roche will jointly develop and commercialize certain products based on antigen presenting cells (APCs) created by the SQZ platform for the treatment of oncology indications.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We believe that this new expanded collaboration accelerates our ability to bring a broad range of impactful oncology products to market," said Armon Sharei, PhD, founder and Chief Executive Officer of SQZ. "We have an ambitious scientific and clinical vision to create transformative cell therapies at SQZ, and we believe our alliance with Roche will yield novel therapeutics for cancer patients."

Under the collaboration, SQZ may receive up to $125 million in upfront payment and near-term milestones. SQZ could earn up to $250 million in clinical, regulatory and sales milestones per product that emerges from the collaboration. In addition, SQZ may receive development milestone payments of over $1 billion. Within the collaboration, SQZ and Roche could share commercial rights for certain approved products.

SQZ APCs leverage native immune functions to spark target-specific killer (CD8) T cell responses in vivo. Through effective presentation of antigens on MHC-I, SQZ APCs can directly stimulate CD8 T cell activity and potentially drive powerful anti-tumor effects that address antigens inaccessible by other adoptive cell-based cancer immune therapy strategies. In addition to their broad targeting potential, the SQZ APC engineering and manufacturing process requires no cellular expansion or genetic modification by viruses or editing agents, thereby dramatically improving the anticipated safety profile, cutting production time, and cost.

The companies will expand the 2015 Roche collaboration to jointly develop therapeutics derived from peripheral blood mononuclear cells (PBMCs).

Howard Bernstein, MD, PhD, Chief Scientific Officer of SQZ, commented "By creating a PBMC APC platform, this collaboration allows for a SQZ APC product engine that could potentially generate products with more potent immunologic responses through a simplified, more efficient manufacturing process."

About SQZ APCs
Antigen presenting cells (APCs), are cells that present antigen on their surface through major histocompatibility complexes (MHCs). APCs are primarily responsible for activating endogenous T cell responses and play a critical role in physiological responses against viruses and tumors. SQZ technology can uniquely access APC biology to engineer effective loading of their MHCs with tumor antigens. When SQZ APCs are injected into an animal, their MHC presented antigens induce powerful, specific CD8 T cell (i.e. killer T cell) responses against the antigen of interest. These CD8 T cells can subsequently drive a strong killing effect against any cell expressing the target antigen. SQZ APCs thus provide a promising platform to drive patient CD8 T cell responses against any tumor target of interest for implementation in a wide range of oncology indications.

On October 15, 2019, Seelos Corporation ("STI"), a wholly-owned subsidiary of Seelos Therapeutics, Inc. ("Seelos"), and Phoenixus AG f/k/a Vyera Pharmaceuticals AG ("Vyera"), reported that it entered into an amendment (the "Amendment") to the Asset Purchase Agreement by and between STI and Vyera, dated March 6, 2018 (the "Initial Agreement"), as amended by a first amendment thereto entered into on May 18, 2018 (the "First Amendment"), and a second amendment thereto entered into on December 31, 2018 (the "Second Amendment" and the Initial Agreement, as amended by the First Amendment and the Second Amendment, the "Purchase Agreement") (Filing, 8-K, Apricus Biosciences, OCT 15, 2019, View Source [SID1234542378]). Pursuant to the Initial Purchase Agreement, STI acquired the assets (the "Vyera Assets") and liabilities (the "Vyera Assumed Liabilities") of Vyera related to a product candidate currently referred to as SLS-002 (intranasal ketamine). Pursuant to the Purchase Agreement, STI agreed that if it received regulatory approval to commence a Phase III clinical trial for SLS-002 and no third party had alleged any claim of conflict, infringement, invalidity or other violation of any rights of others with regard to the Vyera Assets, STI would commence a Phase III clinical trial for SLS-002 by June 30, 2020 (the "Phase III Obligation"), and if STI failed to do so, the Purchase Agreement would terminate immediately and become null and void and all of the Vyera Assets and the Vyera Assumed Liabilities would automatically be returned to Vyera. The Purchase Agreement further provided that as partial consideration for the Vyera Assets, STI agreed to make to Vyera certain one-time, non-refundable milestone payments, including a $3.5 million cash payment upon dosing of the first patient in a Phase III clinical trial for SLS-002 (the "Dosing Milestone").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pursuant to the Amendment, STI remains obligated to use its commercially reasonable efforts to seek regulatory approval in the United States for and commercialize SLS-002. However, the Amendment eliminates the Phase III Obligation. In addition, in replacement of STI’s obligation to pay the Dosing Milestone, STI agreed pursuant to the Amendment to (i) issue Vyera in January 2020 that number of registered shares of Seelos common stock equal to $2,250,000 divided by a 30-day volume weighted average price of the common stock calculated prior to such issuance date and (ii) make cash payments to Vyera in the amounts of $750,000, $750,000, $1 million and $1 million in October 2019, early January 2020, early April 2020 and early July 2020, respectively (each, a "Payment Obligation"). In event STI fails to timely meet a Payment Obligation (subject to a cure period), Vyera has the right to require that all of the Vyera Assets and the Vyera Assumed Liabilities be returned by STI to Vyera.

On October 15, 2019, Aclaris Therapeutics, Inc. (the "Company") and Rigel Pharmaceuticals, Inc. ("Rigel") reported that it entered into a First Amendment (the "First Amendment") to the License and Collaboration Agreement, originally dated as of August 27, 2015 (the "Original Agreement") (Filing, 8-K, Aclaris Therapeutics, OCT 15, 2019, View Source [SID1234542327]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pursuant to the First Amendment, the Company and Rigel agreed to eliminate certain of the development milestones and Rigel released the Company from any obligation to pay a milestone payment for such milestones. The Company also agreed to pay Rigel an amendment fee of $1.5 million to be paid in three equal tranches of $500,000 in January 2020, April 2020 and July 2020. In addition, the parties modified certain other development milestones, and the Company agreed to increase the potential payments payable upon the achievement of such milestones from $10.0 million to $10.5 million in the aggregate. The First Amendment also provides that the Company’s obligation to use commercially reasonable efforts to develop, seek regulatory approval and commercialize at least one product would be deemed satisfied by the Company using commercially reasonable efforts to find a third party to use commercially reasonable efforts to develop, seek regulatory approval and commercialize at least one product.

Except as modified by the First Amendment, all terms and conditions of the Original Agreement remain in full force and effect.