On July 16, 2021 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported that business and financial highlights for Q2 2021 for Nicox SA and its subsidiaries (the "Nicox Group") as well as an update on its strategy and key expected value-inflection milestones today (Press release, NicOx, JUL 16, 2021, View Source [SID1234584900]).

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

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

                  Schedule Your 30 min Free Demo!

"Nicox has made strong progress in the second quarter of 2021, with timely completion of the in-patient part of the NCX 4251 Mississippi Phase 2b trial and continued clinical progress on NCX 470 where the first Phase 3 results are expected in the second quarter of 2022. Our strategy remains to retain the full revenue potential from our fully-owned, product candidates NCX 470 and NCX 4251 in the U.S. and Europe. We believe that this offers a higher potential return than licensing them to third parties and leaves multiple value-creating options open, including organic growth and corporate transactions. We will seek collaborations for NCX 470 and NCX 4251 in other key regions, including Japan, following the Mont Blanc and Mississippi trial results, respectively," said Michele Garufi, Chairman and Chief Executive Officer of Nicox.

"Regarding our partnered commercial products, VYZULTA and ZERVIATE, we have seen significant prescription growth in both cases. While revenue growth has not yet caught up due to pricing and reimbursement mechanisms commonly experienced in the US market in the first years of launch, we expect to see that follow through shortly." added Gavin Spencer, Chief Business Officer of Nicox.

Pipeline Update and Strategy
NCX 470 0.1% ophthalmic solution: Nicox’s lead clinical product candidate, NCX 470, a novel nitric oxide (NO)-donating prostaglandin analog (PGA), is currently in two multi-regional Phase 3 glaucoma clinical trials, with top-line results from the first Phase 3 clinical trial, Mont Blanc, expected in Q2 2022. Results from the second Phase 3 trial, Denali, are expected in 2023. Our objective with these two Phase 3 clinical trials is to demonstrate statistically superior efficacy for the lowering of intraocular pressure (IOP) with once-daily dosed NCX 470 0.1% ophthalmic solution over latanoprost ophthalmic solution 0.005% (first marketed as Xalatan), the most prescribed PGA in the U.S. No monotherapy has previously achieved approval in the U.S. based on trials demonstrating clinical proof of superior efficacy to a PGA, which, if achieved, would clearly differentiate NCX 470 from all other monotherapy products available on the market.

In the Dolomites Phase 2 clinical trial, NCX 470 0.065% ophthalmic solution, a lower dose than the one being tested in Phase 3, already demonstrated a statistically significant improvement in IOP lowering compared to latanoprost. We believe that the higher dose of 0.1% NCX 470, under evaluation in the ongoing Phase 3 trials, has the potential to demonstrate an even greater efficacy than that already observed in the Dolomites trial. Our ongoing Phase 3 program, planned and executed together with our Chinese partner, Ocumension Therapeutics, is expected to support NDA submissions in the U.S. and China, and will also provide data for countries accepting the same package for approval. Our market research suggests peak net sales potential for NCX 470 in the U.S. of over $500 million, if approved and depending on the results of the Phase 3 clinical trials, due to its unique efficacy and safety profile, as well as the choice of latanoprost as a comparator in these trials.

NCX 4251, our novel patented ophthalmic suspension of fluticasone propionate nanocrystals, is currently being tested in the Mississippi Phase 2b clinical trial which evaluates a once-daily 0.1% dose versus placebo for the treatment of acute exacerbations of blepharitis. The in-patient part of the trial has been completed, and top-line results are expected in September 2021. The next steps and timelines in the development of NCX 4251, which are not currently financed, will be announced following an End-of-Phase 2 meeting with the U.S Food and Drug Administration, expected to take place at the beginning of 2022.

Second Quarter 2021 and Recent Operational Highlights
Innovative pipeline

Over 443 out of the 670 patients planned to be included in the NCX 470 Mont Blanc Phase 3 clinical trial have been randomized, and 318 patients have completed the 3-month efficacy evaluation.
Results from the Dolomites Phase 2 trial on NCX 470 in glaucoma were presented by Dr. David Wirta, one of the clinical investigators in the trial, at the World Glaucoma Congress 2021 (June 30 – July 3 2021).
All patients have completed the treatment phase in the NCX 4251 Mississippi Phase 2b blepharitis clinical trial.
Commercial products

The number of prescriptions1 for VYZULTA in the U.S. increased by 21% in the second quarter of 2021 compared to the second quarter of 2020. The corresponding revenue increase has been lower due to pricing considerations in reimbursement.
VYZULTA has been launched in Taiwan, and also approved in Qatar and the United Arab Emirates. VYZULTA is now commercialized by Nicox’s exclusive worldwide partner Bausch + Lomb in the U.S. (2017), Canada (2019), Argentina (2020), Mexico (2020), Hong Kong (2020), and Taiwan (2021), and is now approved in six other territories – Brazil, Colombia, Qatar, South Korea, United Arab Emirates and Ukraine.
The United States Patent and Trademark Office (USPTO) has determined that three U.S. composition of matter patents covering latanoprostene bunod, commercialized as VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, are eligible for patent term extension, potentially through to 2030. The USPTO has also issued a Notice of Allowance for the U.S. patent covering the use of latanoprostene bunod for the treatment of normal tension glaucoma.
The number of ZERVIATES. prescriptions1 increased by 712% in the second quarter of 2021 over the second quarter of 2020.
Nicox entered into an exclusive license agreement with Laboratorios Grin, a wholly-owned subsidiary of Lupin Limited, for the registration and commercialization of ZERVIATETM (cetirizine ophthalmic solution), 0.24% for the treatment of ocular itching associated with allergic conjunctivitis in Mexico. Grin is a Mexican specialty pharmaceutical company engaged in developing, manufacturing and commercialization of branded ophthalmic products.
Corporate

Nicox received $2 million from Ocumension in full advance payment of the future development and regulatory milestones for ZERVIATE in China in consideration of amendments made to certain rights under non-financial clauses of the agreement.
The Company added two new members to its Glaucoma Clinical Advisory Board, Robert N. Weinreb, M.D., Distinguished Professor and Chair, Ophthalmology and Director, Shiley Eye Institute, University of California San Diego, and Sanjay G. Asrani, M.D., Professor of Ophthalmology, Duke University.
Second Quarter 2021 Financial Highlights
As of June 30, 2021, the Nicox Group had cash and cash equivalents of €36.5 million as compared with €42.0 million at March 31, 2021 and €47.8 million at December 31, 2020. The cash at June 30, 2021 is sufficient for the Company to meet its current requirements for the next twelve months. Net revenue2 for the second quarter of 2021 was €0.7 million (including €0.6 million of net royalty payments). Net revenue2 for the second quarter of 2020 was €0.6 million (entirely composed of net royalty payments).

As of June 30, 2021, the Nicox Group had financial debt of €18.0 million consisting of €16.0 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and a €2 million credit agreement with Société Générale and LCL, guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic.

On July 15, 2021 Curtana Pharmaceuticals, a privately-held, preclinical stage biopharmaceutical company, reported that it has signed an agreement with Catalent to support tablet formulation and manufacturing of Curtana’s CT-179, a drug therapy for the treatment of glioblastoma (GBM), medulloblastoma (MB), and other brain cancers (Press release, Curtana Pharmaceuticals, JUL 15, 2021, View Source [SID1234587031]).

CT-179 is a highly potent and selective small molecule inhibitor of OLIG2, a transcription factor that is essential to normal early brain development but is not actively expressed in most normal adult brain cells or in normal tissues outside the brain. However, it is expressed in all diffuse gliomas and it has been shown that OLIG2 drives tumor initiation, tumor growth, invasion into healthy brain tissue, and resistance to chemotherapy and radiation therapy. Studies to-date have demonstrated the viability of CT-179 to markedly prolong survival in numerous, relevant animal models of GBM, MB and other brain cancers. The drug is orally bioavailable, readily crosses the blood-brain barrier, and achieves high concentrations in the brain.

"This is a significant milestone for the company as we move into clinical trials, which are anticipated to commence in the first half of 2022," said Gregory Stein, M.D., M.B.A. and Chief Executive Officer, Curtana Pharmaceuticals. "GBM is a devastating disease with a poor prognosis and a variety of therapeutic challenges. We are excited to bring this easy-to-use oral therapy with the potential to improve quality of life and prolong survival of patients with GBM and other devastating brain cancers."

Formulation development and CGMP manufacturing of the clinical trial product will take place at Catalent’s 98,000 square-foot facility in San Diego, CA. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, CGMP manufacturing, clinical packaging, labeling, and worldwide distribution.

"Catalent is proud to partner with Curtana in the pursuit of a treatment for brain cancer," said Bryan Knox, General Manager of Catalent San Diego. "The Catalent team in San Diego is focused on early-stage development of small molecule and peptide drug candidates, from the bench to the clinic, and our expertise in oral delivery makes us an ideal partner for Curtana on the further development of CT-179."

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

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

                  Schedule Your 30 min Free Demo!

On July 15, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, July 30, 2021 to discuss its second quarter operating results (Press release, ImmunoGen, JUL 15, 2021, View Source [SID1234586881]). Management will also provide a brief update on the business.

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

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

                  Schedule Your 30 min Free Demo!

Conference Call Information

To access the live call by phone, dial (877) 621-5803; the conference ID is 1789134. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

On July 15, 2021 PharmEnable, an AI drug discovery company unlocking challenging biological targets, reported that it has entered into a drug discovery collaboration with LifeArc, an independent UK medical research charity, to apply their respective technologies and expertise to discover novel oral antiviral drugs with activity against coronaviruses (Press release, LifeArc, JUL 15, 2021, View Source [SID1234585348]).

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

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

                  Schedule Your 30 min Free Demo!

The COVID-19 pandemic has not only demonstrated the threat that novel and variant viruses pose, but also the vital role of innovative science to develop vaccines and drugs to combat infection, improving patient health while minimising economic impact. Although vaccines will be invaluable in controlling the pandemic, they are rarely 100% effective. The impact of COVID-19 is showing no signs of abating with the risk of new variants and novel coronaviruses remaining an ever-present threat.

The aim of the risk-sharing collaboration is to produce an oral therapeutic that has broad applicability across SARS-CoV-2 variants and emerging coronaviruses.

PharmEnable’s approach identifies three-dimensional (3D) small molecule drug candidates with improved specificity compared with traditional screening methods. Its proprietary advanced artificial intelligence (AI)-enabled and medicinal chemistry platform allows the company to mine unexplored chemical space to deliver innovative medicines, and has been used to identify and develop novel, highly specific drug leads.

LifeArc plays a vital role in advancing medical research through funding, advice and scientific expertise to translate early discoveries into patient benefit. Since the beginning of the pandemic, LifeArc has contributed £27m to research projects to address the healthcare challenges of COVID-19. Within this collaboration, it will provide resources for the synthesis, optimisation and biological validation of molecules and contribute its expertise in the translation of early-stage science into healthcare treatments.

Dr Hannah Sore, Chief Executive Officer of PharmEnable, said: "We are delighted that PharmEnable was chosen by LifeArc as part of its highly competitive coronavirus initiative. Our platform is proven in its ability to tap unexplored parts of the chemical universe to find novel and specific small molecule candidates for important and challenging targets. Combining our platform with the expertise and experience of LifeArc should enable us to generate several powerful oral drug candidate molecules against SARS-CoV-2 variants and similar viruses.

"We are excited that by working with LifeArc our technology platforms might play a role in expanding the arsenal of treatments available to manage coronavirus-related diseases and save lives."

Dr Justin Bryans, Executive Director, Drug Discovery and Diagnostics at LifeArc added: "We have been actively mobilising our resources and have forged new partnerships to enable us to find ways in which to address the ongoing challenges of COVID-19. This promising new collaboration combines our drug discovery expertise and translational science skills with PharmEnable’s technology to discover novel, anti-viral drug therapies that may be highly effective against evolving coronaviruses."

On July 15, 2021, Generex Biotechnology Corporation (the "Company") reported that it closed on a funding transaction by entering into a Securities Purchase Agreement with an investor pursuant to which the Company agreed to sell and sold a secured convertible promissory note bearing interest at 8% per annum with a 12-month maturity date (the "Note") in the aggregate principal amount of $1,085,000 (Filing, 8-K, Generex, JUL 15, 2021, View Source [SID1234585012]). The purchase price of the Note was $1,000,000 with $70,000 of principal amount represented original issue discount, along with the issuance of 705,173 shares of the Company’s common stock, as inducement shares. Pursuant to the Securities Purchase Agreement, the Company also sold to the Investor warrants to purchase up to an aggregate 904,167 shares of common stock.

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

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

                  Schedule Your 30 min Free Demo!

Subject to certain ownership limitations, the Note will be convertible at the option of the holder six months from the issue date into shares of the Company’s common stock at an effective conversion price of the lower of (i) $0.60 and (ii) 75% of the lowest VWAP during the 30 consecutive trading days immediately preceding the delivery of the conversion. Subject to certain ownership limitations, the warrants will be exercisable after the six-month anniversary of the initial exercise date through the fifth anniversary of issuance at an exercise price of $0.60 per share of common stock.

The conversion price of the Note and the exercise of the warrants will be subject to adjustment in the case of stock splits, stock dividends, combinations of shares, similar recapitalization transactions and certain pro-rata distributions to common stockholders. If the Company defaults on a timely repayment, then the conversion price will also be adjusted if the Company sells or grants any shares of common stock or securities convertible into, or rights to acquire, common stock at an effective price per share that is lower than the then conversion price, except in the event of certain exempt issuances.

The Company is required to file a registration statement with the SEC by July 26, 2021, and have the registration statement become effective within 90 days of closing.

The Company has the right to prepay the Note at a premium after issuance. If the Note is prepaid within 60 days, the Company will pay 105% of the principal amount; if the Note is prepaid after 60 days but prior to 90 days, the Company will pay 110% of the principal amount. If the Note is prepaid after 90, the Company will pay 120% of the principal amount.

The net cash proceeds to the Company from the sale of the Note, after deducting the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offering, is expected to be approximately $1,000,000.

The Note, warrants, and the shares of common stock underlying the warrants, were offered privately pursuant to Rule 506 of Regulation D under the Securities Act of 1933.