NCX

Nicox Provides First Quarter 2024 Update and Full Year 2023 Financial Results

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월요일, 4월 22, 2024
Poster, Marshal of France, International, Drug, Bausch & Lomb, Research, Depreciation, Mass meeting, Sale, NCX, IOP, Kowa, ARVO, Patent, Patient, COVID-19, Nitric oxide, Ocular hypertension, Glaucoma, BlackRock, Pharmaceutical industry

“Nicox made good progress in 2023 as we move towards topline results of the Denali Phase 3 trial which we expect in H2 2025.

Key Points: 
  • “Nicox made good progress in 2023 as we move towards topline results of the Denali Phase 3 trial which we expect in H2 2025.
  • The Nicox Board of Directors has co-opted Dr Gavin Spencer, CEO of Nicox, as a Board member with effect from April 8, 2024.
  • The debt restructuring amendment which was agreed in principle between Nicox and BlackRock and announced on February 28, 2024 was signed.
  • The audit procedures on the 2023 statutory financial statements of Nicox SA have been completed and the certification report is in the process of being issued.

Results from Mont Blanc Phase 3 Trial of Nicox’s NCX 470 in Glaucoma Published in the American Journal of Ophthalmology

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수요일, 3월 20, 2024
IOP, Ocular hypertension, Professor, NCX, Patient, American Journal, American Journal of Ophthalmology, Glaucoma, Vision science, Intraocular pressure, Pharmaceutical industry

Topline results from second Phase 3 trial of NCX 470, Denali, expected in H2 2025

Key Points: 
  • Topline results from second Phase 3 trial of NCX 470, Denali, expected in H2 2025
    Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that the results from the Mont Blanc pivotal Phase 3 trial comparing NCX 470 to latanoprost in the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension have been published in the peer-reviewed journal American Journal of Ophthalmology.
  • “The data from the Mont Blanc Phase 3 trial demonstrated the potential of NCX 470 and we look forward to seeing confirmation of this clinical profile in the upcoming results from the ongoing Denali Phase 3 trial, expected in H2 2025.
  • The Mont Blanc publication concludes that “The NO-donating prostaglandin analogue NCX 470 0.1% was well-tolerated and lowered IOP more than latanoprost in subjects with open-angle glaucoma or ocular hypertension at all 6 time points.
  • With a dual mechanism of action that enhances both uveoscleral and trabecular outflow, NCX 470 could become an important first-line therapy for IOP reduction in glaucoma.”

Nicox Updates on Corporate, Pipeline and Financing Perspectives and Will Hold a Webcast on March 18, 2024

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수요일, 3월 13, 2024
Mont Blanc, IOP, OCT, Whistler, Glaucoma, Ocular hypertension, Fluticasone, Database, Intraocular pressure, NCX, COVID-19, Patient, NDA, BlackRock, Sale, Bausch & Lomb, Therapy, Retina, Allergic conjunctivitis, Safety, Patent, Telecanthus, FDA, Corporation, Food, Pharmaceutical industry

“Nicox is focusing its resources on the Denali Phase 3 pivotal trial of its lead asset NCX 470 in glaucoma.

Key Points: 
  • “Nicox is focusing its resources on the Denali Phase 3 pivotal trial of its lead asset NCX 470 in glaucoma.
  • We are reducing costs, including the size of the organization, and are exploring advancing NCX 1728, through collaborations.
  • In January 2024, Nicox expanded the territory of the exclusive licensing agreement with Harrow, Inc., to include Canada.
  • The Company is financed to at least November 2024, based on focusing exclusively on the development of NCX 470.

Nicox Announces Presentation of Data on NCX 470 at the 2024 American Glaucoma Society Annual Meeting

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화요일, 3월 5, 2024
Mont Blanc, IOP, OAG, Mercury (element), OHT, Annual general meeting, Latanoprost, IOPS, Patient, AGS, NCX, Poster, American Glaucoma Society, Glaucoma, Intraocular pressure, Research, Pharmaceutical industry

“We are proud to have presented data on our lead product candidate NCX 470 in glaucoma to the scientific community at the prestigious AGS meeting.

Key Points: 
  • “We are proud to have presented data on our lead product candidate NCX 470 in glaucoma to the scientific community at the prestigious AGS meeting.
  • The data provide further evidence of the efficacy of NCX 470, and its robust intraocular pressure lowering effect, reinforcing the positive results we have seen in the first Phase 3 trial, Mont Blanc.
  • Furthermore, NCX 470 provided consistent IOP reduction across the spectrum of baseline IOPs while latanoprost IOP reduction was baseline IOP-dependent.
  • In a pre-planned analysis, we tested whether being on previous IOP lowering medications had an impact on the IOP lowering of NCX 470.

Nicox Restructures Debt, Streamlines Operations to Extend Cash Runway and Focus Resources on NCX 470 Pivotal Trial

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수요일, 2월 28, 2024
Ophthalmology, Financial statement, Sale, Communication, BlackRock, Consolidated, 2022–23 Feyenoord season, NCX, Convertible bond, Mass meeting, EGM, NDA, Glaucoma, VWAP, Security (finance)

“The additional cash runway and the overall reduction in cash needs gives us the flexibility to advance our core asset and continue partnering and strategic discussions.

Key Points: 
  • “The additional cash runway and the overall reduction in cash needs gives us the flexibility to advance our core asset and continue partnering and strategic discussions.
  • Specifically, this provides an opportunity to deliver on the promise of NCX 470 in glaucoma, and thereby to preserve and create value.
  • Under the current bond agreement, Nicox was due to begin repaying the Amortizing Bond to Kreos from 1 February 2024.
  • The debt restructuring and cost reductions extend the Company’s cash runway to November 2024, based on focusing exclusively on the development of NCX 470.

Nicox Appoints Experienced Biotech Executive Gavin Spencer as CEO

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수요일, 2월 28, 2024
Pfizer, Chemistry, Bausch & Lomb, Novartis, Doctor of Philosophy, University, Therapy, Boots (company), NCX, Corporation, Glaucoma, Kowa, Partnership, Management

Gavin Spencer was most recently Executive Vice-President, Chief Business Officer & Head of Corporate Development at Nicox.

Key Points: 
  • Gavin Spencer was most recently Executive Vice-President, Chief Business Officer & Head of Corporate Development at Nicox.
  • “I am delighted to welcome Gavin Spencer to his new role as CEO of Nicox.
  • Gavin brings exhaustive industry experience, particularly related to strategic partnership agreements and financing.
  • During his time with Nicox, since 2005, Gavin Spencer has had a key role in building and managing Nicox’s partnerships, including closing agreements with Pfizer, Bausch + Lomb, VISUfarma and Ocumension Therapeutics.

Nicox and Kowa Enter into Agreement for NCX 470 Development and Commercialization in Japan

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목요일, 2월 8, 2024
IOP, Intraocular pressure, Glaucoma, Kowa, Therapy, Ophthalmology, Patient, Marketing, NCX, Business development, Ocular hypertension, Business, Pharmaceutical industry

“We are very pleased to welcome Kowa as an exclusive partner for our lead asset, NCX 470, for the Japanese market.

Key Points: 
  • “We are very pleased to welcome Kowa as an exclusive partner for our lead asset, NCX 470, for the Japanese market.
  • Kowa shall be responsible for all development, regulatory and commercialization costs for NCX 470 in Japan.
  • Kowa expects to conduct additional clinical trials in Japanese patients as required for regulatory approval of NCX 470 in Japan in addition to the development data from Nicox.
  • Including the upfront payment from the Japanese licensing deal for NCX 470, the Company estimates it is currently funded until September 2024, exclusively based on the development of NCX 470.

Nicox announces presentations at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2024

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화요일, 2월 6, 2024
Mont Blanc, IOP, Intraocular pressure, Research, PDE5, Glaucoma, Patient, Dog, Nitric oxide, NCX, Laser, Rabbit, Retina, Ocular hypertension, ARVO

Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced presentations on NCX 470 and NCX 1728 at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2024, a key ophthalmology conference which will be held from May 5 to May 9, 2024 in Seattle, WA, United States.

Key Points: 
  • Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced presentations on NCX 470 and NCX 1728 at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2024, a key ophthalmology conference which will be held from May 5 to May 9, 2024 in Seattle, WA, United States.
  • Results of Mont Blanc, the first of the two Phase 3 clinical trials, have been announced in October 2022.
  • The second Phase 3 clinical trial, Denali, is currently ongoing, and the results are expected in 2025, based on current recruitment rates.
  • The Company estimates it is financed until June 2024, based exclusively on the development of NCX 470.

Nicox Provides Fourth Quarter 2023 Financial and Business Highlights

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목요일, 1월 25, 2024
Glaucoma, Patient, Bausch & Lomb, Marshal of France, NCX, Nitric oxide, Prescription, Ocular hypertension, IOP, COVID-19, Whistler, Intraocular pressure, Pharmaceutical industry

Net revenue €1.3 million for fourth quarter 2023 and €4.2 million for the full year 2023, an increase of 29% compared to the full year 2022

Key Points: 
  • Net revenue €1.3 million for fourth quarter 2023 and €4.2 million for the full year 2023, an increase of 29% compared to the full year 2022
    Cash of €11.9 million on December 31, 2023
    The Company is financed to June 2024, based on the development of NCX 470 alone, and continues to seek opportunities to increase the cash runway
    Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided financial and business highlights for the fourth quarter of 2023 for Nicox SA and its subsidiaries (the “Nicox Group”).
  • The Company remains focused on the financial situation and finding solutions to extend the cash runway.” said Andreas Segerros, Chief Executive Officer of Nicox.
  • In 2024 we are expecting approval and commercialization of ZERVIATE in China, which should further contribute to licensing revenue growth.”
    Net revenue1 for the fourth quarter of 2023 was €1.3 million, compared to €1.0 million of net revenue for the fourth quarter of 2022.
  • As of December 31, 2023, the Nicox Group had cash and cash equivalents of €11.9 million, compared with €14.6 million as of September 30, 2023 and €27.7 million as of December 31, 2022.

Nicox Announces First Patient Screened in the Whistler Phase 3b Trial of NCX 470 in Glaucoma

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월요일, 12월 18, 2023
IOP, Blood, Whistler, Glaucoma, NCX, Intraocular pressure, Ocular hypertension, Mayo Clinic, Bimatoprost, Nitric oxide, Patient, EVP, Clinical professor, Humour, Pharmaceutical industry

Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that the first patient has been screened in the Whistler Phase 3b clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in intraocular pressure (IOP) lowering.

Key Points: 
  • Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that the first patient has been screened in the Whistler Phase 3b clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in intraocular pressure (IOP) lowering.
  • NCX 470, a novel nitric oxide (NO)-donating bimatoprost eye drop, is our lead product candidate in Phase 3 clinical development for IOP lowering in patients with open-angle glaucoma or ocular hypertension.
  • Each subject will participate in the trial for ~8 days and will provide insight into the mechanism of action of NCX 470.
  • The Company is currently funded until the end of June 2024, exclusively on the basis of the development of NCX 470.