Announcement • Aug 14
Ocumension Therapeutics to Report First Half, 2026 Results on Aug 28, 2026 Ocumension Therapeutics announced that they will report first half, 2026 results on Aug 28, 2026 Announcement • Aug 10
Nicox Sa and Ocumension Therapeutics Submit Ncx 470 New Drug Application in China Nicox SA announced that its exclusive licensee in China, Ocumension Therapeutics, has submitted the New Drug Application (NDA) for NCX 470 as a treatment to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The NDA includes the Phase 3 program of both the Mont Blanc trial, and the Denali trial, which specifically included Chinese clinical sites, allowing the program to complete the clinical requirements for approval in China, the same data as recently submitted to the U.S. FDA. Ocumension has already successfully obtained approval for a number of ophthalmology products in China. Ocumension has paid Nicox license fees of EUR 18 million for the rights to develop and commercialise NCX 470 in the Chinese, Korean and Southeast Asian markets, contributed 50% of the Denali clinical trial costs and is one of Nicox’s principal shareholders. Nicox will receive tiered royalties on sales of NCX 470 made by Ocumension ranging from 6% to 12%. Ocumension already has an ophthalmology sales force in place throughout China and is therefore well-positioned for a rapid launch of NCX 470. There is no fixed period for approval of a pharmaceutical product in China, however these are frequently granted in 12 to 18 months following submission. The approval of NCX 470 in China is expected after the approval in the US, where Nicox’s partner Kowa recently submitted an NDA. New Risk • Jul 26
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 13% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. This is currently the only risk that has been identified for the company. Announcement • Jun 09
Ocumension Therapeutics, Annual General Meeting, Jun 30, 2026 Ocumension Therapeutics, Annual General Meeting, Jun 30, 2026, at 10:00 China Standard Time. Location: 56th floor, one museum place office building, no. 669 xinzha road, shanghai China Board Change • May 20
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 6 experienced directors. 1 highly experienced director. 3 independent directors (5 non-independent directors). Independent Non-Executive Director Zhenyu Zhang was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Announcement • Mar 10
Ocumension Therapeutics to Report Fiscal Year 2025 Results on Mar 26, 2026 Ocumension Therapeutics announced that they will report fiscal year 2025 results at 12:30 PM, China Standard Time on Mar 26, 2026 Announcement • Jan 20
Ocumension Therapeutics Completes Enrollment in the Real-World Study of OT-703 The board of directors of the Ocumension Therapeutics announced that one of the Group 's products, OT-703 (ILUVIEN ®, fluocinolone intravitreal implant), an injectable, non-biodegradable fluocinolone acetate intravitreal implant for the treatment of diabetic macular edema (DME), has recently completed the enrollment of a total of 195 patients for the real-world study in Boao Lecheng International Medical Tourism Pilot Zone in Hainan Province, in People's Republic of China. OT-703, namely the 190 microgram fluocinolone acetonide intravitreal implant in applicator (0.19 mg), is an injectable, non-biodegradable fluocinolone acetate intravitreal implant and used for treatment of DME by continuously releasing a microdose of the non-proprietary corticosteroid fluocinolone acetonide (FAc) in the eye, for up to 36 months. It has received the regulatory approval from the United States Food and Drug Administration (FDA) and marketed under the trade name "ILUVIEN®". It is the only FDA-approved corticosteroid intraocular implant for the treatment of DME with a three-year sustained-release period. In April 2021, the Company and Alimera Sciences Inc. ("Alimera") entered into an exclusive license agreement, pursuant to which the Company obtained the exclusive licensed rights from Alimera in relation to the development and commercialization of ILUVIEN® in Greater China, South Korea and 11 countries in Southeast Asia. In December 2023, OT-703 obtained an approval from the Pharmacy and Poisons Board of Hong Kong for its registration as a pharmaceutical product in Hong Kong in accordance with the Pharmacy and Poisons Ordinance (Cap. 138 of the Laws of Hong Kong). Reported Earnings • Aug 24
First half 2025 earnings released: CN¥0.17 loss per share (vs CN¥0.23 loss in 1H 2024) First half 2025 results: CN¥0.17 loss per share (improved from CN¥0.23 loss in 1H 2024). Revenue: CN¥294.0m (up 75% from 1H 2024). Net loss: CN¥132.3m (loss narrowed 13% from 1H 2024). Revenue is forecast to grow 32% p.a. on average during the next 3 years, compared to a 2.8% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 21% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings. Breakeven Date Change • Aug 21 The 2 analysts covering Ocumension Therapeutics previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 62% to 2025. The company is expected to make a profit of CN¥59.4m in 2026. Average annual earnings growth of 126% is required to achieve expected profit on schedule.
Board Change • Aug 18
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 7 experienced directors. No highly experienced directors. 3 independent directors (5 non-independent directors). Independent Non-Executive Director Zhenyu Zhang was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Announcement • Aug 12
Ocumension Therapeutics to Report First Half, 2025 Results on Aug 21, 2025 Ocumension Therapeutics announced that they will report first half, 2025 results on Aug 21, 2025 Announcement • Jul 03
Ocumension Therapeutics Announces Change in Composition of the Nomination Committee The board (the "Board") of directors (the "Directors") of Ocumension Therapeutics (the "Company")
announced that, in response to the amendments to the Corporate Governance Code as set out in Appendix C1 to the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited, which will become effective from July 1, 2025, Dr. Qin XIE, a non-executive Director, and Mr. Ting Yuk Anthony WU, an independent non-executive Director, have been appointed as new members of the nomination committee of the Company (the "Nomination Committee") with effect from June 30, 2025. Following this appointment, the Nomination Committee comprises three independent non-executive Directors (namely Mr. Ting Yuk Anthony WU, Mr. Yiran HUANG and Mr. Zhenyu Zhang) and two non-executive Directors (namely Dr. Lian Yong CHEN and Dr. Qin XIE), with Dr. Lian Yong CHEN remaining as the chairman. Announcement • Apr 28
Ocumension Therapeutics, Annual General Meeting, Jun 19, 2025 Ocumension Therapeutics, Annual General Meeting, Jun 19, 2025, at 10:00 China Standard Time. Location: 56th floor, one museum place office building, no. 669 xinzha road, shanghai China Announcement • Mar 17
Ocumension Therapeutics to Report Fiscal Year 2024 Results on Mar 31, 2025 Ocumension Therapeutics announced that they will report fiscal year 2024 results on Mar 31, 2025 Announcement • Jan 16
Ocumension Therapeutics Announces Change of Non-Executive Director Ocumension Therapeutics announced that Dr. Wei LI, after more than six years of service, has tendered his resignation from the position as a non-executive Director with immediate effect due to his desire to devote more time to his other engagements. The Board further announces that Dr. Qin XIE has been appointed as a non-executive Director with effect from January 16, 2025. The biographical details of Dr. Xie are as follows: Dr. Qin XIE, aged 44, has more than 10 years of extensive experience in pharmaceuticals-related industry. Since September 2017, Dr. Xie has been working in Frontline BioVentures (Shanghai) Limited and Suzhou 6 Dimensions Venture Capital Partnership L.P., each a controlling shareholder of the Company), where she currently serves as a managing partner, primarily responsible for overseeing the overall strategic development. Dr. Xie was also advisor from February 2018 to December 2020. From January 2016 to August 2017, she worked at 6 Dimensions Venture Consultant (Shanghai) Co. Ltd. From September 2013 to December 2015, she had served as a business development manager in Huizheng (Shanghai) Pharmaceutical Technology Co. Ltd. a subsidiary of Zhejiang Hisun Pharmaceutical Co. Ltd. From November 2010 to December 2012, Dr. Xie served as a senior investment manager in Shanghai Pharmaceuticals Holding Co. Ltd. Dr. Xie served as a director from August 2019 to November 2022 and was redesignated as a non-executive director in November 2022 of Cutia Therapeutics. Dr. Xie obtained her bachelor's degree in clinical medicine from the Xi'an Jiaotong University in the PRC in July 2003. She then received her master's degree in pharmacology and doctorate degree in pharmacology from University of Oxford in the United Kingdom in September 2004 and April 2011, respectively. Dr. Xie enters into a service agreement with the Company with an initial term of three years commencing from January 16, 2025, which is subject to etirement by rotation and re-election. Announcement • Dec 03
Ocumension Therapeutics Announces Patient Enrollment Completed in the Second Phase III Clinical Trial of OT-301 in China The board of directors of Ocumension Therapeutics announce that one of the Group's key drug candidates, OT-301 (NCX 470), a first-in-class, nitric oxide (NO)-donating prostaglandin analog under joint development by Nicox S.A. (‘Nicox’) and the Group, has completed the enrollment of over 140 patients for its second phase III clinical trial (the ‘Denali trial’) in China recently. The first phase III clinical trial of NCX 470, namely the Mont Blanc trial, was initiated by Nicox in the United States in June 2020, in which the 0.1% dose was selected over the 0.65% dose through an adaptive design, demonstrating robust efficacy and safety in topline results. The Denali trial is a three-month phase III multi-regional clinical trial evaluating the safety and efficacy of OT-301 (NCX 470) ophthalmic solution, 0.1%, versus the current standard of care, latanoprost ophthalmic solution, 0.005%, for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The Denali trial, which includes a long-term safety extension, has enrolled more than 670 patients at approximately 90 clinical sites in the United States and China. OT-301 (NCX 470) is a new chemical entity invented by Nicox and designed to release both bimatoprost, a United States Food and Drug Administration approved prostaglandin analog, and NO, for the lowering of intraocular pressure in patients with open-angle glaucoma and ocular hypertension. The Group obtained an exclusive license from Nicox to develop, make, have made, import, export and sell OT-301 (NCX 470) in greater China in December 2018, and extended the exclusive right to Korea and 12 countries in Southeast Asia in March 2020. Announcement • Oct 21
Ocumension Therapeutics Announces Resignation of Yumeng Wang as Non-Executive Director The board of directors of Ocumension Therapeutics announced that Ms. Yumeng WANG (Ms. Wang) has resigned as a non-executive Director on the date of this announcement with immediate effect, as she decided to devote more time to her other engagements. Ms. Wang has confirmed that she has no disagreement with the Board and there is no other matter in connection with her resignation as a non-executive Director that needs to be brought to the attention of the shareholders of the Company or The Stock Exchange of Hong Kong Limited (the Stock Exchange). Her resignation will not affect the operation of the Board and the Company. New Risk • Oct 20
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 19% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (11% average weekly change). Minor Risk Shareholders have been diluted in the past year (19% increase in shares outstanding). Announcement • Sep 24
Ocumension Therapeutics Announces New Drug Application of OT-502 Accepted by the National Medical Products Administration The board of directors of the Ocumension Therapeutics announced that the new drug application for OT-502 (DEXYCU, dexamethasone implant), a new drug for the treatment of postoperative inflammation indication, has been accepted by the National Medical Products Administration of the People's Republic of China (the PRC) recently. OT-502 (DEXYCU ®, dexamethasone implant) is a single-dose, sustained-release solution of dexamethasone, a corticosteroid, for the treatment of postoperative inflammation. To date, OT- 502 is the first and only single-dose, sustained-release intracameral steroid for the treatment of postoperative inflammation that was approved by the United States Food and Drug Administration. The Group is developing OT-502 as a potential first-in-class treatment for postoperative inflammation associated with cataract surgery in China. The phase III clinical trial of OT-502 is designed to be a randomized, double-masked, placebo-controlled, parallel-group, multi-center clinical and pharmacokinetic study to evaluate the efficacy and safety of 9% dexamethasone implant in the treatment of post-cataract surgery inflammation, which has achieved its primary endpoints in the PRC in April 2024. Announcement • Sep 19
Ocumension Therapeutics Announces New Drug Application of OT-1001 Approved by the National Medical Products Administration Ocumension Therapeutics announced that the new drug application for OT-1001 (ZERVIATE ®), a potent and highly selective histamine-1 receptor antagonist with anti-allergic properties, has been approved by the Center for Drug Evaluation of the National Medical Products Administration (the "NMPA") of the People's Republic of China (the "PRC") recently. OT-1001 (ZERVIATE®), developed by Nicox Ophthalmics Inc. ("Nicox"), has been approved by the United States Food and Drug Administration (FDA) for use in patients aged two years and older. The Group obtained an exclusive license from Nicox to develop, make, have made, import, export, use, distribute, market, promote, offer for sale and sell (or otherwise commercialize) OT- 1001 (ZERVIATE ®) in the Greater China region in March 2019, and extended the exclusive rights to 11 countries in Southeast Asia in March 2020. OT-1001 is the first and only eye drop formulation of the antihistamine cetirizine, the active ingredient in ZYRTEC®, and is currently commercialized in the United States for ocular itching associated with allergic conjunctivitis. It is believed that the approval for marketing of OT-1001 (ZERVIATE®), which addresses unmet medical needs or has the potential to offer significant improvements over existing treatment options, will benefit patients suffering from the same symptoms in the PRC. Cautionary Statement: The Company cannot guarantee that OT-1001 (ZERVIATE ®) will ultimately be successfully marketed. Shareholders of the Company and potential investors are advised to exercise caution when dealing in the shares of the Company. New Risk • Aug 15
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: CN¥323m Forecast net loss in 2 years: CN¥37m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. This is currently the only risk that has been identified for the company. Reported Earnings • Aug 14
First half 2024 earnings released: CN¥0.23 loss per share (vs CN¥0.32 loss in 1H 2023) First half 2024 results: CN¥0.23 loss per share (improved from CN¥0.32 loss in 1H 2023). Revenue: CN¥167.6m (up 62% from 1H 2023). Net loss: CN¥151.3m (loss narrowed 27% from 1H 2023). Revenue is forecast to grow 40% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has fallen by 33% per year, which means it is significantly lagging earnings. Buy Or Sell Opportunity • Aug 05
Now 21% undervalued after recent price drop Over the last 90 days, the stock has fallen 10% to €0.76. The fair value is estimated to be €0.96, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 74% over the last 3 years. Earnings per share has grown by 90%. Revenue is forecast to grow by 225% in 2 years. Earnings are forecast to grow by 99% in the next 2 years. Announcement • Jul 30
Ocumension Therapeutics to Report First Half, 2024 Results on Aug 12, 2024 Ocumension Therapeutics announced that they will report first half, 2024 results on Aug 12, 2024 Announcement • Jul 17
Ocumension Therapeutics Announces Biologic License Application for OT-702 Accepted by the National Medical Products Administration The board of directors of the Ocumension Therapeutics announced that biologic license application (BLA) for OT-702 (Aflibercept Intravitreous Injection, EYLEA® biosimilar) has been accepted by the Center for Drug Evaluation (“CDE”) of the National Medical Products Administration of the People’s Republic of China (the “PRC”) recently. OT-702 was co-developed by the Group and its partner Shandong Boan Biotechnology Co. Ltd. Pursuant to the cooperation and exclusive promotion agreement entered into by both parties in October 2020, the Group, together with Boan Bio, shall co-advance the phase III clinical trial of OT-702, and the Group was granted the exclusive right to promote and commercialize the product in the PRC. OT-702, as a soluble trapping receptor, can bind to cytokines such as VEGF-A, VEGF-B and P1GF, inhibit the downstream signaling pathway of VEGFR, inhibit neovascularization, and reduce vascular permeability, thereby treating pathological neovascularization of the retina and choroid eye diseases. OT-702 is a biosimilar to EYLEA®, the globally approved indications of which include neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), diabetic retinopathy (DR), myopic choroidal neovascularization (mCNV) and retinopathy of prematurity (ROP). According to Technical Guidelines for Similarity Evaluation and Indication Extrapolation of Biosimilars issued by CDE, OT-702 is eligible to apply for approval for all indications approved for EYLEA® in the PRC. The completed pre-clinical head-to-head comparison study of OT-702 to EYLEA® (Aflibercept Intravitreous Injection) showed OT-702 shared a high degree of similarity in both physical and chemical properties and biological activities with EYLEA®. The results of the phase I clinical trial of OT-702 showed that the safety and tolerability of OT-702 demonstrated in the trial group were consistent with and comparable to those of the original reference drug demonstrated in the original reference drug group. The phase III clinical trial of OT-702, a randomized, double-blind, parallel-controlled and multicenter clinical study to compare the efficacy and safety of OT-702 to EYLEA® in the treatment of wet age-related macular degeneration, was completed in April 2024. The results of the phase III clinical trial demonstrated clinically significant improvement in the eye’s best corrected visual acuity (BCVA) under study at weeks 4, 8, 12, 16, 20 and 24 compared with the baseline (by using the early treatment of diabetic retinopathy study (ETDRS) visual acuity chart) for the patients in both trial group and original reference drug group. The therapeutic effectiveness of OT-702 and the original reference drug is highly comparable, where the onset of action of both is rapid and lasting, signifying the fulfillment of all clinical trial endpoints. Announcement • May 25
Ocumension Therapeutics, Annual General Meeting, Jun 20, 2024 Ocumension Therapeutics, Annual General Meeting, Jun 20, 2024, at 10:00 China Standard Time. Location: 56th floor, one museum place office building, no. 669 xinzha road, shanghai China Reported Earnings • Apr 30
Full year 2023 earnings released: CN¥0.58 loss per share (vs CN¥0.64 loss in FY 2022) Full year 2023 results: CN¥0.58 loss per share (improved from CN¥0.64 loss in FY 2022). Revenue: CN¥246.4m (up 55% from FY 2022). Net loss: CN¥379.8m (loss narrowed 5.7% from FY 2022). Products in clinical trials Phase I: 2 Phase II: 1 Phase III: 4 Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 90% per year but the company’s share price has fallen by 28% per year, which means it is significantly lagging earnings. Buy Or Sell Opportunity • Mar 27
Now 21% undervalued after recent price drop Over the last 90 days, the stock has fallen 14% to €0.66. The fair value is estimated to be €0.83, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 74% over the last 3 years. Earnings per share has grown by 89%. Revenue is forecast to grow by 80% in a year. Earnings are forecast to grow by 34% in the next year. Reported Earnings • Mar 24
Full year 2023 earnings released: CN¥0.59 loss per share (vs CN¥0.64 loss in FY 2022) Full year 2023 results: CN¥0.59 loss per share (improved from CN¥0.64 loss in FY 2022). Revenue: CN¥246.4m (up 55% from FY 2022). Net loss: CN¥379.8m (loss narrowed 5.7% from FY 2022). Products in clinical trials Phase I: 2 Phase II: 1 Phase III: 4 Revenue is forecast to grow 34% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 89% per year but the company’s share price has fallen by 33% per year, which means it is significantly lagging earnings. Breakeven Date Change • Mar 24
Forecast to breakeven in 2025 The 4 analysts covering Ocumension Therapeutics expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 28% to 2024. The company is expected to make a profit of CN¥19.8m in 2025. Average annual earnings growth of 89% is required to achieve expected profit on schedule. New Risk • Mar 23
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.2% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. This is currently the only risk that has been identified for the company. Announcement • Mar 14
Ocumension Therapeutics Announces Phase II Clinical Trial of OT-202 Ocumension Therapeutics announced that, the phase II clinical trial of OT-202 (tyrosine kinase inhibitor), a first-in-class new drug self-developed by the Company for the treatment of dry eye, has successfully completed the unblinding with all related data collected, which marks OT-202 has achieved the primary clinical endpoint of phase II clinical trial, i.e., the group that received the treatment with the drug exhibited greater improvement in corneal staining scores from baseline compared to the placebo group by day 56. The drug has also demonstrated positive results in safety and efficacy. The Company expects to launch phase III clinical trial of OT-202 in the near future. OT-202 (tyroine kinase inhibitor) is a first-in-class New drug self-developed by the company for the treatment of moderate to severe dry eye. The mechanism of action of OT-202 is that the dualtargeted inhibitor of spleen tyrosine kinase (Syk) and vascular endothelial growth factor receptor-2 achieves a synergistic effect in the treatment of dry eye diseases and inhibits the inflammatory response. OT-202 demonstrated good safety and tolerability profile in healthy adult subjects in the phase I clinical trial successfully completed in February 2023. The phase II clinical trial of OT -202, which was launched in February 2023 and designed to be a randomized, double-masked, placebo-controlled clinical trial on the safety and efficacy of the drug, has completed the enrollment of a total of 213 patients for the phase II clinical trial in China in November 2023. Announcement • Mar 08
Ocumension Therapeutics to Report Fiscal Year 2023 Results on Mar 21, 2024 Ocumension Therapeutics announced that they will report fiscal year 2023 results on Mar 21, 2024 Announcement • Dec 14
Ocumension Therapeutics (SEHK:1477) commences an Equity Buyback for 69,071,128 shares, representing 10% of its issued share capital, under the authorization approved on June 16, 2023. Ocumension Therapeutics (SEHK:1477) commences share repurchases on November 30, 2023, under the program mandated by the shareholders in the Annual General Meeting held on June 16, 2023. As per the mandate, the company is authorized to repurchase up to 69,071,128 shares, representing 10% of its issued share capital. The repurchases will result in an increase in the net asset value and/or earnings per share. The repurchase program will be funded out of funds legally available for the purpose in accordance with the Articles of Association, the Listing Rules and the applicable laws and regulations of the Cayman Islands. The authority shall expire at the earliest of the next Annual General Meeting, the date on which the next Annual General Meeting is required to be held or the date on which the authority is varied or revoked in a General Meeting. As at June 16, 2023, the company has 690,711,280 shares in issue.
On November 29, 2023, the company announce a share repurchase program. Under the program, the company will repurchase up to HKD 100 million worth of its shares. The repurchase program will be funded from the company’s existing available cash. The repurchased shares will be cancelled. Announcement • Nov 30
Ocumension Therapeutics Completes Enrollment in the Phase Iii Clinical Trial of OT-502 in China The board of directors of Ocumension Therapeutics announced that OT-502 (dexamethasone implant), a new drug for the treatment of postoperative inflammation indication, has completed the enrollment of a total of 300 patients for the phase III clinical trial in China on November 29, 2023. OT-502 (dexAMethasone implant) is a single-dose, sustained-release solution of dexamethasone, a corticosteroid, for the treatment of postoperativeinflamm. To date, OT-502 is the first and only single-dose, sustained- release intracameral steroid for the treatment of postoperative inflammatory that was approved by the United States Food and Drug Administration. The Group is developing OT-502 as a potential first-in-class treatment for postoperative inflammation associated with cataract surgery in China. The phase III clinical trial of OT-502 is designed to be a randomized, double-masked, placebo-controlled, parallel-group, multi-center clinical and pharmacokinetic study to evaluate the efficacy and safety of 9% dexamethasone implant in the treatment of postoperative inflammation. Announcement • Nov 23
Ocumension Therapeutics Completes Patient Enrollment in the Phase II Clinical Trial of OT-202 in China The board of directors of Ocumension Therapeutics announced that OT-202 (tyrosine kinase inhibitor), a class I new drug self-developed by the Company for the treatment of dry eye, has completed the enrollment of a total of 213 patients for the phase II clinical trial in China on November 21, 2023. OT-202 (tyrosine kinase inhibitor) is a class I innovative drug self-developed by the Company for the treatment of moderate to severe dry eye. The mechanism of action of OT-202 is that the dual-targeted inhibitor of spleen tyrosine kinase (Syk) and vascular endothelial growth factor receptor-2 achieves a synergistic effect in the treatment of dry eye diseases and inhibits the inflammatory response. OT-202 demonstrated good safety and tolerability profile in healthy adult subjects in the phase I clinical trial successfully completed in February 2023. The phase II clinical trial of OT-202, which was launched in February 2023, is designed to be a randomized, double-masked, placebo-controlled clinical trial on the safety and efficacy of the drug. Announcement • Oct 01
Ocumension Therapeutics Announces Executive Changes, Effective September 30, 2023 The board of directors of Ocumension Therapeutics announced that (i) due to personal reasons, Ms. Yun JI ("Ms. JI") has tendered her resignation as a joint company secretary of the Company (the "Joint Company Secretary"), and will cease to act as a Joint Company Secretary with effect from September 30, 2023; and (ii) Ms. CHAU Hing Ling ("Ms. CHAU") has tendered her resignation as (a) a Joint Company Secretary, and (b) an authorized representative of the Company pursuant to Rule 3.05 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (the "Stock Exchange") (the "Authorized Representative"), and will cease to act as a Joint Company Secretary and an Authorized Representative with effect from September 30, 2023. Following the cessation of Ms. JI and Ms. CHAU to act as a Joint Company Secretary, respectively, the Board announced that (i) Mr. Tim RUAN and Ms. Tingchan CHEN have been appointed as Joint Company Secretaries in place of Ms. JI and Ms. CHAU with effect from September 30, 2023; and (ii) Mr. RUAN has been appointed as an Authorized Representative in place of Ms. CHAU with effect from September 30, 2023. The biographical details of Mr. RUAN and Ms. CHEN are set out below: MR. RUAN Mr. RUAN, aged 37, has been chief financial officer since January 12, 2023, responsible for financial management and investor relations of the Group. Mr. RUAN has extensive experience of financial management. Prior to joining Group, he served as an executive director of the investment banking division of Goldman Sachs (Asia) L.L.C. from November 2020 to January 2023, primarily responsible for affairs in debt and equity capital markets and M&A. From January 2018 to November 2020, he served as a vice president of the investment banking division of Morgan Stanley Asia Limited. From February 2016 to January 2018, he acted as an associate within the investment banking division of Nomura International (Hong Kong) Limited. From September 2013 to January 2016, he served as associate at Sullivan & Cromwell LLP. Mr. RUAN graduated from The Hong Kong University of Science and Technology in November 2021 with a master's degree of science, majoring in biotechnology. He graduated from The University of New South Wales in December 2009 with bachelor's degree of laws and bachelor's degree of commerce majoring in finance. MS. CHEN Ms. CHEN, aged 29, joined the Company on July 1, 2021 and currently serves as the securities affairs manager of the Company. Ms. CHEN has several years of experience in corporate governance and company secretarial practice. Prior to joining Group, Ms. CHEN served as the senior manager of capital markets and investor relations at Shanghai Fosun High Technology (Group) Co. Ltd., a subsidiary of Fosun International Limited from September 2020 to June 2021. From April 2017 to September 2020, she served as the supervisor of the secretariat to the board at Guangzhou Baiyunshan Pharmaceutical Holdings Co. Ltd. Ms. CHEN obtained her bachelor's degree in business administration from The Chinese University of Hong Kong in November 2016 and her master's degree in corporate governance from Hong Kong Metropolitan University in March 2023. She has been an associate member of The Hong Kong Chartered Governance Institute since July 2023. New Risk • Aug 28
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: CN¥418m Forecast net loss in 2 years: CN¥165m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (CN¥165m net loss in 2 years). Share price has been volatile over the past 3 months (6.5% average weekly change). Shareholders have been diluted in the past year (2.8% increase in shares outstanding). Reported Earnings • Aug 27
First half 2023 earnings released: CN¥0.32 loss per share (vs CN¥0.31 loss in 1H 2022) First half 2023 results: CN¥0.32 loss per share (further deteriorated from CN¥0.31 loss in 1H 2022). Revenue: CN¥103.7m (up 90% from 1H 2022). Net loss: CN¥208.4m (loss widened 8.2% from 1H 2022). Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 3.1% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 141% per year but the company’s share price has fallen by 31% per year, which means it is significantly lagging earnings. Announcement • Aug 15
Ocumension Therapeutics to Report First Half, 2023 Results on Aug 24, 2023 Ocumension Therapeutics announced that they will report first half, 2023 results on Aug 24, 2023 Announcement • Jul 23
Ocumension Therapeutics Announces Clinical Trial Authorization for Initiating A Phase III Clinical Trial of Ot-101-S Ocumension Therapeutics announced that a phase III clinical trial authorization for initiating a randomized, double-masked, placebo-controlled, parallel-group, multicenter clinical trial for OT-101-S, a self-developed product of the Group, has recently been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the People's Republic of China. OT-101-S (0.01% and 0.05% atropine sulfate eye drop) is a low-concentration (0.01% and 0.05%) atropine sulfate eye drop developed by the Group to retard, or slow down, the progression of myopia in children. The instability of atropine sulfate solutions under physiological (neutral) pHconditions has long been a technical barrier towards commercialization. Studies show that, as compared to the high-concentration (0.5%-1%) atropine sulfate eye drop which has frequently reported adverse events including photophobia and blurred vision, low-concentration atropine sulfate eye drop has demonstrated good tolerability, safety and efficacy results. As compared to OT-101, which is designed to contain two chambers of atropine sulfate lyophilized powder and solvent for each dosage unit, OT-101-S is designed to contain two chambers of atropine sulfate concentrated solution and diluted solution for each dosage unit, thus leading to a higher level ofconvenience for the storage and usage of atropine sulfate. The Group believes OT-101-S will solve the instability of atropine sulfate solutions under physiological (neutral) pH conditions and thus become a reliable treatment method for myopia in children. Breakeven Date Change • Jul 07
Forecast to breakeven in 2025 The 4 analysts covering Ocumension Therapeutics expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 31% per year to 2024. The company is expected to make a profit of CN¥532.3m in 2025. Average annual earnings growth of 60% is required to achieve expected profit on schedule. Announcement • Jun 02
Ocumension Therapeutics Completes Patient Enrollment in Globalmulti-Center Phase III Clinical Trial of OT-101 The board of directors of Ocumension Therapeutics announced that OT-101 (0.01% atropine sulfate eye drop), a self-developed new drug to treat the progression of myopia in children, has completed the enrollment of 678 patients for the global phase III randomized, double-masked, placebo-controlled, parallel-group, multi-center clinical trial on June 1, 2023. OT-101 (0.01% atropine sulfate eye drop) is a low-concentration (0.01%) atropine eye drop developed to retard, or slow down, the progression of myopia in children and adolescents, which is the only Anticholinergic medication to date that has been demonstrated to be consistently effective and safe in controlling myopic progression. However, the instability of low-concentration atropine solutions has long been a technical barrier towards commercialization. In response to these obstacles, OT-101 uses an innovative closed-loop split device of exclusive design to improve the reliability, closure integrity and sterility conditions of the device, so that it can be as close as possible to the current medication environment for the preparations of low-concentration atropine for use in the hospital, thus solving the stability problem of low-concentration atropine solution in neutral environment. Also, the appropriate pH value improves the comfort of patients being treated and medication compliance. The Group believes, the technical breakthroughs in response to the stability issue of low-concentration (0.01%) atropine will be its core competitiveness. The phase III clinical trial of OT-101 is the world's first multi-regional phase III clinical trial for low-concentration atropine and its analogs that includes Chinese population. To date, no low-concentration atropine ophthalmic preparations have been commercialized in the global mainstream pharmaceutical market. In February 2023, the Company has completed the enrollment of 170 patients in China for the global phase III clinical trial of OT-101. The Company believes that the completion of patients enrollment of OT-101 in the global multi-center phase III clinical trial is another important step towards commercialization of the drug, demonstrating the Company's continued business strength. Reported Earnings • Mar 31
Full year 2022 earnings released: CN¥0.64 loss per share (vs CN¥0.43 loss in FY 2021) Full year 2022 results: CN¥0.64 loss per share (further deteriorated from CN¥0.43 loss in FY 2021). Revenue: CN¥159.0m (up 183% from FY 2021). Net loss: CN¥402.6m (loss widened 55% from FY 2021). Revenue is forecast to grow 36% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany. Announcement • Feb 15
Ocumension Therapeutics Provides Preliminary Unaudited Consolidated Group Earnings Guidance for the Year Ended December 31, 2022 Ocumension Therapeutics provided preliminary unaudited consolidated group earnings guidance for the year ended December 31, 2022. For the year, the group expects to record a total revenue of approximately RMB 155.0 million to RMB 159.0 million, representing an increase of approximately 176% to 183% as compared to the total revenue of approximately RMB 56.1 million for the year ended December 31, 2021; and a gross profit of approximately RMB 100.0 million to RMB 103.0 million, representing an increase of approximately 171% to 179% as compared to the gross profit of approximately RMB 36.9 million for the year ended December 31, 2021. The increase in the total revenue and the gross profit in 2022 is mainly attributable to: the commercialization of the Company's Core Product, OT-401 (fluocinolone intravitreal implant, trade name: Youshiying®; the increase in the revenue generated from sales of ophthalmic products, including Ou Qin® and brimonidine tartrate eye drop, among others; and the increase in the revenue generated from the pharmaceutical products promotion services. Breakeven Date Change • Feb 06
Forecast to breakeven in 2024 The 4 analysts covering Ocumension Therapeutics expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 11% per year to 2023. The company is expected to make a profit of CN¥54.1m in 2024. Average annual earnings growth of 69% is required to achieve expected profit on schedule. Announcement • Feb 04
Ocumension Therapeutics Provides Update on Phase I Clinical Trial of Ot-202 Ocumension Therapeutics announced that the phase I clinical trial of OT-202 (tyrosine kinase inhibitor), a class I new drug developed by the Company for the treatment of dry eye, has been completed successfully. The phase I clinical trial of OT-202 was designed as a randomized, double-masked, placebo- controlled clinical trial on the safety, tolerability and pharmacokinetic properties for its single/multiple administration on healthy adult subjects in China. A total of 30 subjects were enrolled for the phase I clinical trial in China. OT-202 demonstrated good safety and tolerability profile in healthy adult subjects in the phase I clinical trial. Currently, the Company is in the process of advancing the study for the phase II clinical trial. OT-202 (tyrosine kinase inhibitor) is a class I innovative drug developed by the Company for the treatment of moderate to severe dry eye. The mechanism of action of OT-202 is that the dual- targeted inhibitor of spleen tyrosine kinase (Syk) and vascular endothelial growth factor receptor-2 achieves a synergistic effect in the treatment of dry eye diseases and inhibits the inflammatory response. Announcement • Feb 02
Ocumension Therapeutics Announces Patient Enrollment Complete in the Phase III Clinical Trial of OT-101 in China The board of directors of Ocumension Therapeutics announced that OT-101 (0.01% atropine sulfate eye drop), a self-developed new drug to treat the progression of myopia in children, has completed the enrollment of 170 patients in China for the global phase III randomized, double-masked, placebo-controlled, parallel-group, multicenter clinical trial on January 18, 2023. The phase III clinical trial of OT-101 is the world's first multi-regional phase III clinical trial for low-concentration atropine and its analogs that includes Chinese population. To date, no low-concentration atropine ophthalmic preparations have been commercialized in the global mainstream pharmaceutical market. OT-101 (0.01% atropine sulfate eye drop) is a low-concentration (0.01%) atropine eye drop developed to retard, or slow down, the progression of myopia in children and adolescents, which is the only Anticholinergic medication to date that has been demonstrated to be consistently effective and safe in controlling myopic progression. However, the instability of low-concentration atropine solutions has long been a technical barrier towards commercialization. In response to these obstacles, OT-101 uses an innovative closed-loop split device of exclusive design to improve the reliability, closure integrity and sterility conditions of the device, so that it can be as close as possible to the current medication environment for the preparations of low-concentration atropine for use in the hospital, thus solving the stability problem of low-concentration atropine solution in neutral environment. Also, the appropriate pH value improves the comfort of patients being treated and medication compliance. The Group believes, the technical breakthroughs in response to the stability issue of low-concentration (0.01%) atropine will be its core competitiveness. Buying Opportunity • Jan 11
Now 21% undervalued after recent price drop Over the last 90 days, the stock is down 8.4%. The fair value is estimated to be €1.52, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 181% over the last year. Earnings per share has grown by 41%. Revenue is forecast to grow by 688% in 2 years. Earnings is forecast to grow by 80% in the next 2 years. Board Change • Nov 16
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 3 were independent directors. The company's board is composed of: 3 independent directors. 6 non-independent directors. Independent Non-Executive Director Zhenyu Zhang was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Reported Earnings • Aug 28
First half 2022 earnings released: CN¥0.31 loss per share (vs CN¥0.12 loss in 1H 2021) First half 2022 results: CN¥0.31 loss per share (down from CN¥0.12 loss in 1H 2021). Revenue: CN¥54.5m (up 162% from 1H 2021). Net loss: CN¥192.7m (loss widened 177% from 1H 2021). Over the next year, revenue is forecast to grow 228%, compared to a 6.6% growth forecast for the Pharmaceuticals industry in Germany. Announcement • Aug 17
Ocumension Therapeutics to Report First Half, 2022 Results on Aug 26, 2022 Ocumension Therapeutics announced that they will report first half, 2022 results on Aug 26, 2022 Announcement • Jun 24
Ocumension Therapeutics Receives Approval from the National Medical Products Administration for Yutio Chronic Non-Infectious Uveitis Ocumension Therapeutics announced that the New Drug Application (NDA) for the core product in its pipeline, OT-401 (Sterile non-bioerodible intravitreal implant, Product name: YUTIO), was officially approved by the National Pharmaceutical Administration (NMPA) for the treatment of chronic non-infectious uveitis involving the posterior segment of the eye (chronic NIU-PS). This is the first new drug in Ocumension's pipeline to be approved for marketing and is currently the potential best-in-class therapy for the treatment of this indication in China. Ocumension is a Chinese ophthalmic pharmaceutical platform company dedicated to identifying, developing and commercialising first-in-class or best-in-class ophthalmic therapies. To date, Ocumension has 23 drug assets in the immediate and posterior segments of the eye and has established a complete ophthalmic drugpipeline, ofwhich seven products are in Phase III clinical trials and its core product, OT-401 (Sterile non-bioerodible intravitreal implant), has been officially approved for marketing. The approval of YUTIO in China marks an important milestone for EyePoint and Ocumension in our shared mission to provide extended-release drug therapy to patients suffering from ocular disease. OT-401 will fill a gap in the treatment of chronic non-infectious uveitis Non-infectious uveitis is a chronic form of uveitis that can lead to a variety of complications such as cataracts and glaucoma, and when the inflammation is not promptly controlled, it can also lead to impairedvision or even permanent vision loss. The complexity of the clinical presentation of non-infectious uveitis and the high degree of similarity between subtypes pose significant diagnostic and differential problems. Patients with uveitis are most typically characterised by an early age onset and have a tendency to relapse, with an average age of onset of approximately 33 years. Each episode of inflammation causes irreversible damage to intraocular tissues and 46% of patients eventually develop irreversible low vision or blindness, making it the second most blinding eye disease in China. As the first-in-class product for the treatment of chronic non-infectious uveitis, YUTIO is the first and only new FDA-approved drug for the treatment of chronic non-infectious uveitis involving the posterior segment of the eye, with low-dose intraocular administration and stable drug release over a period of up to 36 months. The development and introduction of YUTIO will improve the treatment dilemma of Chinese uveitis patients, delay recurrent attacks, avoid serious systemic complications, and fill a gap in the treatment of chronic non-infectious uveitis. Ophthalmology experts have high hopes for the future contribution of YUTIO in the field of uveitis The fascinating product OT-401 was first approved by the FDA on 12 October 2018 for the treatment of chronic non-infectious uveitis involving the posterior segment of the eye, and Ocumension subsequently introduced this innovative product to China and became Eyepoint's largest strategic shareholder in 2021. The OT-401 was first used in China in August 2019, providing a powerful treatment for chronic non-infectious uveitis in China, through the "privileged access, early and pilot" policy granted by the State to the Boao LeCheng Advance Hospital, a powerful treatment. Announcement • Jun 22
EyePoint Pharmaceuticals, Inc. and OcuMension Therapeutics Announce Approval of New Drug Application by China's NMPA for YUTIQ(R) for the Treatment of Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye EyePoint Pharmaceuticals, Inc. and OcuMension Therapeutics announced that China'sCenter for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has approved YUTIQ(R) (fluocinolone acetonide intravitreal implant) 0.18mg for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. YUTIQ is the first drug approved for commercialization in China based entirely on real-world data, as well as the first drug approved for commercial use in OcuMension's innovative pipeline. In September 2020, OcuMension launched a real-world study of YUTIQ for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye at Boao Lecheng Super Hospital in Hainan Province through the urgent clinical need channel granted to Boao Lecheng Pilot Zone. In April 2021, the CDE accepted OcuMension's new drug application (NDA) for YUTIQ that was filed with the real-world data collected at Boao Lecheng Super Hospital. YUTIQ received approval by the U.S. Food and Drug Administration (FDA) on October 18, 2018. The treatment is currently marketed by EyePoint in the U.S., and EyePoint maintains development and commercialization rights for YUTIQ for the treatment of non-infectious uveitis affecting the posterior segment of the eye in the Americas and in Asia. About Non-Infectious Uveitis Affecting the Posterior Segment of the Eye Non-infectious uveitis affecting the posterior segment of the eye is a chronic form of uveitis that may cause a variety of complications, including cataracts and glaucoma. When the inflammation is not controlled in a timely manner, it can lead to visual impairment or even permanent vision loss. The complex clinical presentation of non-infectious uveitis and the high degree of similarity between subtypes pose a significant challenge for accurate diagnosis. There are 1.4 million patients with this condition in China. About YUTIQ(R): (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic, non- infectious uveitis affecting the posterior segment of the eye, and was approved by the FDA on October 12, 2018. Announcement • Jun 16
Ocumension Therapeutics Announces Executive Changes Ocumension Therapeutics announced that Ms. Pui Chun Hannah SUEN who is a joint company secretary of the Company has tendered her resignation as the manager of corporate services of Vistra Corporate Services (HK) Limited,which is the external corporate services provider of the Company. As a result of the aforesaid resignation, Ms. SUEN ceased to act as (i) the Joint Company Secretary; (ii) an authorized representative of the Company pursuant to Rule 3.05 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited and (iii) an authorized representative of the Company to accept service of process and notices on behalf of the Company in Hong Kong as required under Rule 19.05(2) of the Listing Rules and Part 16 of the Companies Ordinance (Chapter 622 of the Laws of Hong Kong) with effect from June 15, 2022. Following the cessation of Ms. SUEN to act as a Joint Company Secretary, the Board announce that Ms. CHAU Hing Ling has been appointed as a Joint Company Secretary, the Authorized Representative and the Process Agent with effect from June 15, 2022. Ms. Yun JI will continue to serve as the other Joint Company Secretary. Ms. JI was appointed as the Secretary of the Board and the Joint Company Secretary on April 28, 2020. Ms. Ji has been strategic project director since February 27, 2020, responsible for IPO project and the following capitalization operation. Prior to joining Group, from September 2012 to February 2020, she served as head manager of board of directors office in Shanghai Pharmaceuticals Holding Co. Ltd. a company whose shares are listed on the Shanghai Stock Exchange and the Stock Exchange where she led a team responsible for corporate governance, public disclosure, investor relations management and other securities affairs. Ms. CHAU is currently an executive director of corporate services of Vistra Corporate Services (HK) Limited. She has over twenty years of experience in the corporate services industry. She is currently the company secretary/joint company secretaries of certain listed companies. Ms. CHAU obtained a master of laws majoring in corporate and financial law from The University of Hong Kong in November 2007. She has been a fellow member of The Hong Kong Chartered Governance Institute and a fellow member of The Chartered Governance Institute in United Kingdom since May 2013. Announcement • Jun 10
Ocumension Therapeutics Announces CDE Approval Received for A Phase III Clinical Trial of OT-703 in China The board of directors of Ocumension Therapeutics announced that the investigational new drug (IND) application for OT-703 (fluocinolone intravitreal implant), an injectable, non-biodegradable fluocinolone acetate intravitreal implant for the treatment of diabetic macular edema (DME), has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the People's Republic of China to conduct a randomized, double-blind, parallel-controlled, multi-center phase III clinical trial to compare the safety and efficacy of 0.19 mg fluocinolone intravitreal implant with ranibizumab injection on the treatment of DME in China. OT-703, namely the 190 microgram fluocinolone acetonide intravitreal implant in applicator (0.19 mg), is an injectable, non-biodegradable fluocinolone acetate intravitreal implant and used for treatment of DME by delivering a continuous microdose of the non-proprietary corticosteroid fluocinolone acetonide (FAc) in the eye, for up to 36 months. It has received the regulatory approval from the United States Food and Drug Administration (FDA) and marketed under the trade name "ILUVIEN®". It is the only FDA-approved corticosteroid intraocular implant for the treatment of DME with a three-year sustained-release period. Announcement • Jun 09
Ocumension Therapeutics Receives Approval from the National Medical Products Administration for its IND Application to Begin the Phase Iii Clinical Study for Fluocinolone Acetonide Intravitreal Implant Ocumension Therapeutics received approval from the National Medical Products Administration for its IND application to begin the Phase III clinical study for fluocinolone acetonide intravitreal implant in support of a filing for marketing approval to treat diabetic macular edema in mainland China. The IND application was for a randomized, multicenter Phase III clinical study of 0.19 mg Fluocinolone Acetonide Intravitreal Implant in the treatment of diabetic macular edema. The intent of the trial is to support a future NDA filing to gain marketing approval in the country with an equivalent indication to Alimera’s U.S. indication (for the treatment of diabetic macular edema previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure). Board Change • Apr 27
Less than half of directors are independent There are 6 new directors who have joined the board in the last 3 years. Of these new board members, 3 were independent directors. The company's board is composed of: 3 independent directors. 6 non-independent directors. Independent Non-Executive Director Zhenyu Zhang was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Announcement • Apr 09
Ocumension Therapeutics Appoints Mr. Zhenyu Zhang as Independent Non-Executive Director, the Chairman of the Remuneration Committee and a Member of the Nomination Committee and Audit Committee Ocumension Therapeutics announce that Mr. Zhenyu ZHANG has been appointed as an independent non-executive director, the chairman of the remuneration committee and a member of the nomination committee and audit committee of the Company with effect from April 8, 2022. Mr. Zhang, aged 46, has more than 20 years of experience in legal and corporate compliance practice. He currently serves as the vice president responsible for legal, compliance and governmental affairs of Greater China region for The a2 Milk Company Limited. Announcement • Apr 01
Ocumension Therapeutics Announces Demise of Lianming HE, Independent Non-Executive Director, Chairman of the Remuneration Committee and Member of the Audit Committee and Nomination Committee The board of directors of Ocumension Therapeutics announced with the deepest sorrow that Mr. Lianming HE ("Mr. He"), an independent non-executive director, the chairman of the remuneration committee and a member of the audit committee and nomination committee of the Company, passed away on March 30, 2022. Breakeven Date Change • Mar 30
Forecast to breakeven in 2024 The 4 analysts covering Ocumension Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of CN¥91.3m in 2024. Average annual earnings growth of 54% is required to achieve expected profit on schedule. Announcement • Mar 04
Ocumension Therapeutics Voluntary Announcement primary Clinical Endpoint Achieved in the Phase III clinical Trial of OT-1001 The board (the "Board") of directors of the Company announced that the phase III clinical trial of OT-1001 (ZERVIATE), a potent and highly selective histamine-1 receptor antagonist with anti-allergic properties, has achieved its primary clinical endpoint and received positive results. OT-1001 (ZERVIATE) was developed by Nicox Ophthalmics Inc. ("Nicox"). OT-1001 is the first and only eye drop formulation of the antihistamine cetirizine, the active ingredient in ZYRTEC®, and is currently commercialized in the United States for ocular itching associated with allergic conjunctivitis. Studies have shown that OT-1001 is a safe and effective antihistamine therapeutic agent. OT-1001 has a rapid onset of action, and the effect is able to last for at least 8 hours after administration. OT-1001 covers a wide range of patients. In addition to treating adult patients, the safety and effectiveness of OT-1001 has been established in pediatric patients two years of age and older, therefore meeting the current clinical needs of treating pediatric patients with allergic conjunctivitis. The Group obtained an exclusive license from Nicox to develop, make, have made, import, export, use, distribute, market, promote, offer for sale and sell (or otherwise commercialize) OT-1001 (ZERVIATE) in the Greater China region in March 2019, and extended the exclusive rights to 11 countries in Southeast Asia in March 2020. In December 2020, the first patient has been successfully enrolled and dosed in the phase III clinical trial of OT-1001 in China. The phase III clinical trial of OT-1001 was designed as a randomized, observer-masked, positive control, multi-center parallel clinical trial to evaluate the safety and efficacy of the cetirizine hydrochloride ophthalmic solution of 0.24% concentration in comparison with emedastine difumarate ophthalmic solution of 0.05% concentration for Chinese patients with allergic conjunctivitis. A total of 296 patients were randomized across multiple clinical sites in China. O -1001 was found to be non-inferior to emedastine difumarate in the primary efficacy endpoint of change from baseline in the itching score in the 24 hours prior to the Day 14 visit. OT-1001 was safe and well-tolerated with no difference in the proportion of patients with adverse events compared to emedastine difumarate. The successful completion of this clinical trial is an important step towards commercialization of OT-1001. Announcement • Mar 03
Nicox’s Partner Ocumension Obtains Positive Phase 3 Clinical Trial Results for ZERVIATE® in China Nicox SA announced positive results in a Chinese Phase 3 clinical trial of ZERVIATE® (cetirizine ophthalmic solution), 0.24%, run by its Chinese partner, Ocumension Therapeutics. ZERVIATE was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine marketed under the brand name EMADINE®. ZERVIATE was found to be non-inferior to emedastine difumarate in the primary efficacy endpoint of change from baseline in the itching score in the 24 hours prior to the Day 14 visit. ZERVIATE was safe and well-tolerated with no difference in the proportion of patients with adverse events compared to emedastine difumarate. This clinical trial is required for Ocumension to be able to submit a New Drug Application (NDA) for approval to commercialize ZERVIATE in China. Clinical Trial Design: This was a randomized, observer-masked, Phase 3 clinical trial to evaluate the safety and efficacy of ZERVIATE (cetirizine ophthalmic solution), 0.24% dosed twice daily compared to emedastine difumarate ophthalmic solution, 0.05% dosed twice daily in Chinese patients with allergic conjunctivitis. The treatment period was 14 days and the primary efficacy endpoint was a non-inferiority analysis of the change from baseline in the itching score within the 24 hours prior to the Day 14 visit. A total of 296 patients were randomized across multiple clinical sites in China. ZERVIATE Partnerships: ZERVIATE is exclusively licensed to Ocumension Therapeutics for development and commercialization in the Chinese and the majority of the Southeast Asian markets. Nicox may potentially receive sales milestones of up to USD 17.2 million together with royalties of between 5% and 9% of net sales of ZERVIATE by Ocumension. ZERVIATE is commercialized in the U.S. by exclusive U.S. partner Eyevance Pharmaceuticals, a wholly-owned subsidiary of Santen Pharmaceutical Co. Ltd. of Japan, and is also exclusively licensed to Samil Pharmaceutical in South Korea, to ITROM Pharmaceutical Group in certain Gulf and Arab markets, and to Laboratorios Grin in Mexico. Announcement • Jan 05
Ocumension Therapeutics Announces First Patient Enrolled in the Clinical Trial of self-Developed Class I New Drug OT-202 in China Ocumension Therapeutics announced that OT-202 (tyrosine kinase inhibitor), a class I new drug self-developed by the Company for the treatment of dry eye, has completed the first patient enrollment for its randomized, double-blind, placebo-controlled clinical trial on the safety, tolerability and pharmacokinetic properties for its single/multiple administration on healthy trial subjects in China. OT-202 (tyrosine kinase inhibitor) is the Company's first self-developed class I novel targeted new drug for the treatment of dry eye. The core mechanism of dry eye is mainly due to a variety of factors and diseases caused by the decrease in tear production or high evaporation, which leads to hypertonicity of tears. This hypertonic state activates by a series of inflammations on the ocular surface and releases inflammatory mediators into the tears fluid, and thus the cycle continues. The key treatment for dry eye is to break the vicious circle of inflammation. Spleen tyrosine kinase (Syk) is a cytoplasmic protein kinase, which plays a key role in a variety of biological functions, including classical immunoreceptor such as activating Fc receptors (FcR) and the intracellular signal cascade of B cells receptors (BCRs) that are particularly significant for the initiation of inflammation. Syk inhibitors can be used for the treatment of various allergic diseases, autoimmune diseases and inflammatory diseases. Syk is the target of OT-202, which achieves anti-inflammatory effects by inhibiting the activity of Syk kinase, which has shown significant therapeutic effects and anti-inflammatory effects in the guinea pigs' immune-type dry eye model and the mice's scopolamine dry eye model. The toxicology studies have also shown that it is well-tolerated in the body of animals. Reported Earnings • Sep 24
First half 2021 earnings released: CN¥0.12 loss per share (vs CN¥27.36 loss in 1H 2020) First half 2021 results: Net loss: CN¥69.6m (loss narrowed 96% from 1H 2020). Announcement • Sep 15
Ocumension Therapeutics Receives CDE Approval for Commencement of a Phase III Clinical Trial OT-502 (DEXYCU®) in China The board of directors of Ocumension Therapeutics announced that OT-502 (DEXYCU®), one of the Group's key drug candidates, was approved by the Center for Drug Evaluation of the National Medical Products Administration of the People's Republic of China to conduct a phase III clinical trial in China. OT-502 (DEXYCU®), approved to launch in the United States by the United States Food and Drug Administration on February 9, 2018, is the first and only FDA-approved, sustained-release intraocular drug for the treatment of postoperative inflammation indication. Inflammation is a common symptom following cataract surgery and may cause severe complications if not treated timely. To date, hormonal and antibiotic eye drops are common in clinical use to treat postoperative inflammation over two to four weeks. However, cataract surgery patients are often elderly, and their medication compliance is worse. Utilizing the drug delivery platform Verisome®, OT-502 can deliver dexamethasone into anterior chamber, directly inhibiting the synthesis and release of inflammatory mediators in anterior chamber. It works well in inhibiting responses to postoperative anterior chamber inflammation and avoids frequent use of topical hormonal eye drops, which effectively resolves non-compliance of cataract surgery patients, so as to provide a better treatment choice for the management of postoperative inflammation. Reported Earnings • Aug 23
First half 2021 earnings released: CN¥0.12 loss per share (vs CN¥27.36 loss in 1H 2020) First half 2021 results: Net loss: CN¥69.6m (loss narrowed 96% from 1H 2020). Announcement • Aug 04
Ocumension Therapeutics MHRA Approval Received for Phase III Clinical Trial of OT-101 in the United Kingdom Ocumension Therapeutics (the ‘Company’, together with its subsidiaries, the ‘Group’) on a voluntary basis to keep the shareholders of the Company and potential investors informed of the latest business updates of the Group. The board (the ‘Board’) of directors of the Company announced that OT-101 (0.01% atropine sulfate eye drop), a self-developed new drug to treat the progression of myopia in children, was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to conduct a phase III randomized, double-masked, placebo-controlled, parallel-group, multi-center study on the safety and efficacy in treating the progression of myopia in pediatric subjects. The phase III clinical trial of OT-101 is the world's first multi-regional phase III clinical trial for low-concentration atropine and its analogs that includes Chinese population. In April 2021, the first patient enrollment for OT-101's phase III clinical trial in the United States was completed. In July 2021, OT-101 was also approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the People's Republic of China to conduct a phase III clinical trial. To date, no low-concentration atropine ophthalmic preparations has been commercialized in the global mainstream pharmaceutical market. OT-101 (atropine 0.01%) is a low-concentration (0.01%) atropine eye drop developed to retard, or slow down, the progression of myopia in children and adolescents, which is the only anticholinergic medication to date that has been demonstrated to be consistently effective and safe in controlling myopic progression. However, the instability of low-concentration atropine solutions has long been a technical barrier towards commercialization. In response to these obstacles, OT-101 uses an innovative closed-loop split device of exclusive design to improve the reliability, closure integrity and sterility conditions of the device, so that it can be as close as possible to the current medication environment for the preparations of low-concentration atropine for use in the hospital, thus solving the stability problem of low-concentration atropine solution in neutral environment. Also, the appropriate pH value improves the comfort of patients being treated and medication compliance. The Group believes that the technical breakthroughs in response to the stability issue of low-concentration (0.01%) atropine will be its core competitiveness. Announcement • Jul 15
Ocumension Therapeutics Announces CDE Approval Received for A Phase III Clinical Trial of OT-101 Ocumension Therapeutics announced that OT-101 (0.01% atropine sulfate eye drop), a self-developed new drug to treat the progression of myopia in children, was approved by the Center for Drug Evaluation of the National Medical Products Administration of the People's Republic of China (CDE) to conduct a phase III randomized, double-blind, parallel group, placebo-controlled, multi-center clinical trial on the safety and effectiveness of the treatment of myopia progression in children. The phase III clinical trail of OT-101 has become the world's first multi-regional phase III clinical trial for low-concentration atropine and its analogs that includes the Chinese population. In April 2021, the first patient enrollment for OT-101's phase III clinical trial in the United states was completed. The phase III clinical trial application for OT-101 in the United Kingdom and the European Union has also been accepted recently. To date, no low-concentration atropine ophthalmic preparations has been commercialized in the global mainstream pharmaceutical market. OT-101 (atropine 0.01%) is a low-concentration (0.01%) atropine eye drop developed to retard, or slow down, the progression of myopia in children and adolescents, which is the only Anticholinergic medication to date that has been demonstrated to be consistently effective and safe in controlling myopic progression. However, the instability of low-concentration atropine solutions has long been a technical barrier towards commercialization. In response to these obstacles, OT- 101 uses an innovative closed-loop split device of exclusive design to improve the reliability, closure integrity and sterility conditions of the device, so that it can be as close as possible to the current medication environment for the preparations of low-concentration atropine for use in the hospital, thus solving the stability problem of low-concentration atropine solution in neutral environment. Also, the appropriate pH value improves the comfort of patients being treated and medication compliance. The Group believes that the technical breakthroughs in response to the stability issue of low-concentration (0.01%) atropine will be its core competitiveness. Announcement • May 21
Ocumension Therapeutics Announces Clinical Trial Authorization for Initiatinga Phase III Clinical Trial of OT-101 Accepted in United Kingdom Ocumension Therapeutics announced that a clinical trial authorization for initiating a multi-regional phase III clinical trial (the "Phase III MRCT") in the United Kingdom for OT-101, a self-developed product of the Group, has recently been accepted by the Medicines and Healthcare products Regulatory Agency of the United Kingdom. Once the Phase III MRCT is approved, OT-101 is expected to be the world's first phase III MRCT of low concentration atropine and its analogues that includes Chinese population. OT-101 is a low-concentration atropine 0.01% eye drop developed by the Group to retard, or slow down, the progression of myopia in children and adolescents. The instability of low-concentration atropine solutions has long been a technical barrier for its commercialization. The Group developed a storage and delivery system to address low-concentration atropine solution's instability, and also conducted several rounds of tests on the system's reliability, closure integrity and sterility conditions. Announcement • May 12
Ocumension Therapeutics Announces Investigational New Drug Application for Initiating A Multi-Regional Phase Iii Clinical Trial in the People's Republic of China for OT-101 The board (the "Board") of directors of Ocumension Therapeutics announced that an investigational new drug application for initiating a multi-regional phase III clinical trial (the "Phase III MRCT") in the People's Republic of China for OT-101, a self-developed product of the Group, has recently been accepted by Center for Drug Evaluation of the National Medical Products Administration of the People's Republic of China. Once the Phase III MRCT is approved, OT-101 is expected to be the world's first phase III MRCT of low concentration atropine and its analogues that includes Chinese population. OT-101 is a low-concentration atropine 0.01% eye drop developed by the Group to retard, or slow down, the progression of myopia in children and adolescents. The instability of low-concentration atropine solutions has long been a technical barrier for its commercialization. The Group developed a storage and delivery system to address low-concentration atropine solution's instability, and also conducted several rounds of tests on the system's reliability, closure integrity and sterility conditions. Executive Departure • Mar 24
Non-Executive Director has left the company On the 19th of March, Lefei Sun's tenure as Non-Executive Director ended after less than a year in the role. We don't have any record of a personal shareholding under Lefei's name. Lefei is the only executive to leave the company over the last 12 months. Announcement • Mar 21
Ocumension Therapeutics Announces Board Changes Ocumension Therapeutics announced that Mr. Lefei SUN has tendered his resignation from the position as a non-executive Director with effect from March 19, 2021 due to
his desire to devote more time to other business commitments. Ms. Yumeng WANG has been appointed as a non-executive Director with effect from March 19, 2021. Ms. Wang, aged 30, is currently a vice president at General Atlantic Service Company, L.P. Announcement • Mar 20
Ocumension Therapeutics, Annual General Meeting, Jun 29, 2021 Ocumension Therapeutics, Annual General Meeting, Jun 29, 2021. Is New 90 Day High Low • Mar 12
New 90-day low: €2.32 The company is down 6.0% from its price of €2.46 on 11 December 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 5.0% over the same period. Announcement • Mar 10
Ocumension Therapeutics to Report Fiscal Year 2020 Results on Mar 19, 2021 Ocumension Therapeutics announced that they will report fiscal year 2020 results on Mar 19, 2021 Announcement • Mar 05
Nicox’s NCX 470 Receives Approval by Chinese Authorities for Local Start of Denali Phase 3 Trial Nicox SA announced that its partner, Ocumension Therapeutics, has received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to conduct the Chinese part of the ongoing NCX 470 Denali Phase 3 clinical trial for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. Nicox’s lead clinical product candidate, NCX 470, is a novel nitric oxide (NO)-donating prostaglandin analog licensed exclusively to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets. Denali, the second Phase 3 trial of NCX 470 for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, was initiated in the U.S. on November 9, 2020. Denali is a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005% and will also include a long-term safety extension. NCX 470 is also being studied in Mont Blanc, a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, against latanoprost ophthalmic solution, 0.005%, for lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Top-line results are currently expected in H1 2022. Announcement • Mar 04
Ocumension Therapeutics Announces Second Phase III Clinical Trial of OT-301 Approved in China Ocumension Therapeutics announced that one of the Group's key drug candidates, OT-301, a first-in-class, nitric oxide (NO)-donating prostaglandin analog under joint development by Nicox S.A. and the company, has recently obtained an approval from the Center for Drug Evaluation of the National Medical Products Administration of the People's Republic of China for initiating its second phase III clinical trial, namely the Denali trial, in China. The first phase III clinical trial of NCX 470, namely the Mont Blanc trial, has been initiated by Nicox in the United States in June 2020, in which the 0.1% dose was selected over the 0.65% dose through an adaptive design. The 0.065% dose of NCX 470 was the highest dose tested in the phase II clinical trial, namely the Glaucoma Dolomites trial, where demonstrated a superior intraocular pressure lowering treatment effect compared with latanoprost 0.005%, the most widely prescribed first-line therapy for glaucoma and ocular hypertension in China. The Denali trial is a three-month phase III multi-regional clinical trial evaluating the safety and efficacy of OT-301(NCX 470) ophthalmic solution, 0.1%, versus the current standard of care, latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. The Denali trial, which will also include a long-term safety extension, is expected to randomize approximately 670 patients, at approximately 50 clinical sites in the United States and China. As of the date of this announcement, the Denali trial has been initiated in the United States by Nicox with the first patient enrolled on November 9, 2020. Announcement • Feb 23
Ocumension Therapeutics Announces Investigational New Drug Approval for Initiating A Multi-Regional Phase III Clinical Trial Ocumension Therapeutics announced that an investigational new drug approval for initiating a multi-regional phase III clinical trial in the United States for OT-101, a self developed product of the Group, has been received from the United States Food and Drug Administration in February 2021. The company plans to file IND applications with the regulatory authorities in both China and Europe Union in 2021 and initiate the Phase III MRCT of OT-101 in these regions accordingly. OT-101 is a low-concentration atropine 0.01% eye drop developed by the Group to retard, or slow down, the progression of myopia in children and adolescents. The instability of low-concentration atropine solutions has long been a technical barrier for its commercialization. The Group developed a storage and delivery system to address low-concentration atropine solution's instability, and also conducted several rounds of tests on the system's reliability, closure integrity and sterility conditions. Announcement • Feb 10
Ocumension Therapeutics Announces Phase III Clinical Trial of the Recently In-Licensed Drug Candidate of the Group The board of directors of Ocumension Therapeutics announced that a phase III clinical trial of the recently in-licensed drug candidate of the Group, OT-702 (LY09004), has been initiated and the first patient dosing has recently been completed in the clinical trial in mainland China. OT-702 (LY09004) was jointly developed by the Group and a subsidiary of Luye Pharma Group Ltd. ("Luye Pharma"), whose shares are listed on the Main Board of The Stock Exchange of Hong Kong Limited (the "Stock Exchange") (stock code: 02186), pursuant to a collaboration and exclusive promotion agreement entered on October 30, 2020 (the "Agreement"). OT-702 is a recombinant human vascular endothelial growth factor receptor antibody fusion protein ophthalmic injection (strength 11.12mg (0.278ml)/Vial). As a biosimilar to EYLEA®(aflibercept intraocular injection solution), OT-702 is indicated for the treatment of patients with neovascular wet age-related macular degeneration, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). As a soluble trapping receptor, OT-702 can bind to cytokines such as VEGF-A, VEGF-B and P1GF, inhibit the downstream signaling pathway of VEGFR, inhibit neovascularization, and reduce vascular permeability, thereby treating pathological neovascularization of the retina and choroid eye diseases. The head-to-head comparison of OT-702 to EYLEA® (aflibercept intraocular injection solution) showed a high degree of similarity in both physical and chemical properties and biological activities. The results of its phase I clinical trial showed that OT-702 has a good safety and tolerability profile without serious adverse reactions. The phase III clinical trial of OT-702 is designed to be a randomized, double-blind, parallel-controlled and multicenter clinical trial to compare the efficacy and safety of OT-702 to EYLEA (aflibercept intraocular injection solution) in the treatment of wet age-related macular degeneration. Pursuant to the Agreement, the Group will jointly develop OT-702 with Luye Pharma in the phase III clinical trial of OT-702. The Group has obtained an exclusive right from Luye Pharma to promote and commercialize OT-702 in mainland China under the Agreement. Announcement • Jan 24
Ocumension Therapeutics has completed a Follow-on Equity Offering in the amount of HKD 1.5876 billion. Ocumension Therapeutics has completed a Follow-on Equity Offering in the amount of HKD 1.5876 billion.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 56,000,000
Price\Range: HKD 28.35
Transaction Features: Subsequent Direct Listing Announcement • Jan 14
Ocumension Therapeutics announced that it expects to receive HKD 793.8 million in funding from 6 Dimensions Capital, L.P. Ocumension Therapeutics (SEHK: 1477) announced that it has entered into a subscription agreement for a private placement of 28,000,000 shares at a price of HKD 28.35 per share for gross proceeds of HKD 793,800,000 on January 13, 2021. The transaction will include participation from returning investor 6 Dimensions Capital, L.P. The company will pay HKD 11,200,000 as issue expenses and will receive net proceeds of HKD 782,600,000 in the transaction. Post closing of the transaction, the stake held by the investor in the company will decrease from 44.15% to 42.16%. The investor is acquiring a 4.74% stake in the company as part of this transaction. All securities issued will be subject to a lock-up period of 6 months from the date of completion. Is New 90 Day High Low • Jan 12
New 90-day high: €3.00 The company is up 23% from its price of €2.44 on 14 October 2020. The German market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 12% over the same period. Is New 90 Day High Low • Dec 22
New 90-day high: €2.70 The company is up 1.0% from its price of €2.68 on 23 September 2020. The German market is up 9.0% over the last 90 days, indicating the company underperformed over that time. However, its price trend is similar to the Pharmaceuticals industry, which is also up 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Dec 02
Ocumension Therapeutics Initiates the Real World Study of Its Core Product, OT-401 (YUTIQ) in Boao Super Hospital in Hainan Province, China The board of directors of Ocumension Therapeutics announce that the Group has recently initiated the real world study of its core product, OT-401 (YUTIQ) in Boao Super Hospital in Hainan province, China, and is recruiting patients simultaneously in various ophthalmic clinical centers across the country. At the same time, a phase III clinical study of OT-401 evaluating the safety and efficacy of fluocinolone vitreous implants in patients with chronic non-infectious uveitis affecting the posterior segment of the eye is also underway in various ophthalmic clinical centers across the country. The real world study data of OT-401 are expected to provide support and supplement to the phase III clinical trial data of OT-401. The real-world study, a more cost-effective and less time-consuming supplement to the traditional clinical trial, aims to form clinical evidence in relation to the use and potential benefits or risks of medical products by analysing the patient-related data collected in a real-world environment. The initiation of the real world study of OT-401 is expected to accelerate the new drug application registration in China. OT-401 (YUTIQ), the core product of the Company, is a first-in-class, innovative injectable, sustained-release micro-insert for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. OT-401 is a sterile non-bioerodible intravitreal implant designed to provide sustained release of a total of 0.18 mg of the active ingredient fluocinolone acetonide, a corticosteroid, at a controlled rate for up to 36 months from a single administration performed in an outpatient visit. To date, YUTIQ is the first and only uveitis treatment designed to deliver fluocinolone for up to 36 months that has been approved by the U.S. Food and Drug Administration. Announcement • Oct 27
Ocumension Therapeutics Receives Approval by Chinese Authorities for Local Start of Mont Blanc Phase 3 Trial Ocumension Therapeutics has received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to carry out the Chinese part of the ongoing Mont Blanc trial, the first Phase 3 clinical trial on NCX 470 for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. NCX 470, Nicox’s lead clinical product candidate, is a novel second generation nitric oxide (NO)-donating bimatoprost analog exclusively licensed to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets. Is New 90 Day High Low • Oct 24
New 90-day low: €2.30 The company is down 32% from its price of €3.40 on 24 July 2020. The German market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Sep 22
Ocumension Therapeutics Receives Approval from China’S Center for Drug Evaluation of the National Medical Products Administration Ocumension Therapeutics, has received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to carry out Phase 3 clinical trials on ZERVIATETM (cetirizine ophthalmic solution), 0.24% for the treatment of ocular itching associated with allergic conjunctivitis. ZERVIATE, the first topical ocular form of cetirizine, is licensed exclusively to Ocumension Therapeutics in the Chinese and in the majority of South East Asian markets. The Phase 3 trial is expected to start in fourth quarter of 2020. Announcement • Aug 18
Ocumension Therapeutics to Report First Half, 2020 Results on Aug 26, 2020 Ocumension Therapeutics announced that they will report first half, 2020 results on Aug 26, 2020 Announcement • Jul 17
Ocumension Therapeutics announced that it has received $20 million in funding Ocumension Therapeutics (SEHK:1477) announced that it has received $20 million in Series A round of funding in February 2019. 
