On July 19, 2021 Immunic, Inc. (the "Company") (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported the closing of an underwritten public offering of 4,500,000 shares of its common stock at a public offering price of $10.00 per share (Press release, Immunic, JUL 19, 2021, View Source [SID1234584952]).

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The Company received total proceeds from the offering, before deducting the underwriting discounts and other offering expenses, of $45.0 million.

Piper Sandler acted as sole book-runner for the offering. Ladenburg Thalmann & Co. Inc., Roth Capital Partners and Aegis Capital Corp. acted as co-managers for the offering.

The Company intends to use the net proceeds of the offering to fund the ongoing clinical development of its three lead product candidates, IMU-838, IMU-935 and IMU-856, and for other general corporate purposes.

The securities described above were offered by the Company pursuant to a shelf registration statement filed by the Company with the Securities and Exchange Commission ("SEC"), which was declared effective on November 24, 2020. A final prospectus supplement and accompanying prospectus related to the offering were filed with the SEC on July 16, 2021 and are available for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus related to the offering may be obtained from Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by email at [email protected], or by telephone at (800) 747-3924.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 19, 2021 Sareum Holdings plc (AIM: SAR), the specialist drug development company, reported that it has raised £1,000,000, before expenses, through a subscription by a high net worth individual (the "Subscriber") for 14,285,714 new ordinary shares of 0.025p each in the capital of the Company ("Ordinary Shares") (the "Subscription Shares") at a price of 7p per share (the "Subscription Price") (the "Subscription") (Press release, Sareum, JUL 19, 2021, View Source [SID1234586708]).

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Under the terms of the Subscription, the new Subscriber will also be issued one five-year warrant, exercisable at the Subscription Price, for every Subscription Share issued (the "Subscription Warrant"), which can only be exercised following the Company’s closing middle market share price being above 9p per Ordinary Share for five consecutive days. The Subscription Price represents a premium of approximately 4.5 per cent. to the closing middle market price for Sareum Shares on 16 July 2021.

The net proceeds from the Subscription will be used to progress the Company’s SDC-1801 and SDC-1802 TYK2/JAK1 inhibitor drug development programmes as well as for working capital purposes. As noted in the Company’s Trading Update of 25 May 2021, the Company is targeting the completion of preclinical studies for SDC-1801 in Q3 2021, subject to successful progress. Clinical trial plans, including priority autoimmune indications and potential Covid-19 application, will also be developed in parallel, subject to additional funding being raised.

Application will be made for the 14,285,714 Subscription Shares, which will rank pari passu with the Company’s existing Ordinary Shares, to be admitted to trading on the AIM market of the London Stock Exchange ("AIM") ("Admission"). It is anticipated that Admission will become effective at 8.00 am on 23 July 2021. The Subscription is subject to normal conditions including, inter alia, Admission.

Total Voting Rights

For the purpose of the Disclosure Guidance and Transparency Rules, following the above issue of equity, the issued share capital of the Company will comprise 3,353,579,936 Ordinary Shares. The above figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company, under the Disclosure Guidance and Transparency Rules.

Dr Tim Mitchell, CEO of Sareum Holdings plc, said: "We are delighted that our proprietary TYK2/JAK1 development programmes are attracting such interest and new investment. With this new subscription, the total funds raised from recent subscriptions and warrant exercises is over £3.5 million. These new funds will allow us both to advance SDC-1801 into clinical development in autoimmune diseases, including the immune overreaction to Covid-19 and other viral infections, and to progress the preclinical development of our second TYK2/JAK1 inhibitor SDC-1802 against cancers."

On July 19, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to COSELA (trilaciclib) investigation for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC) (Press release, G1 Therapeutics, JUL 19, 2021, View Source [SID1234587574]). COSELA is currently being evaluated in PRESERVE 2, a pivotal Phase 3, randomized, double-blind, placebo-controlled study (NCT04799249) in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for TNBC.

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Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs. The purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track designation may be eligible for more frequent engagements with the FDA to discuss the drug’s clinical development plan, eligibility for Accelerated Approval and Priority Review, and Rolling Review in which the Company can submit completed sections of its New Drug Application (NDA) for FDA review rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

"Fast Track designation underscores the urgent need for innovative drugs that can significantly improve TNBC patient outcomes," said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. "It provides an important pathway to help expedite the development and regulatory review of COSELA in this indication. We look forward to working closely with the FDA as we advance this pivotal program in TNBC and continue to work to unlock the broader potential of this pipeline-in-a-molecule compound that we hope will help patients across multiple tumor types."

About Triple Negative Breast Cancer (TNBC)
According to the American Cancer Society, nearly 300,000 new cases of invasive breast cancer are diagnosed annually in the U.S. Triple-negative breast cancer makes up approximately 15% to 20% of such diagnosed breast cancers. TNBC is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. Because TNBC cells lack key growth-signaling receptors, patients do not respond well to medications that block estrogen, progesterone, or HER2 receptors. Instead, treating TNBC typically involves chemotherapy, radiation, and surgery. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer. In general, survival rates tend to be lower with TNBC compared to other forms of breast cancer, and TNBC is also more likely than some other types of breast cancer to return after it has been treated, especially in the first few years after treatment. It also tends to be higher grade than other types of breast cancer.

On July 19, 2021 Johnson & Johnson (NYSE: JNJ) reported that its Board of Directors has declared a cash dividend for the third quarter of 2021 of $1.06 per share on the company’s common stock (Press release, Johnson & Johnson, JUL 19, 2021, View Source;johnson-announces-quarterly-dividend-for-third-quarter-2021-301336582.html [SID1234584953]). The dividend is payable on September 7, 2021 to shareholders of record at the close of business on August 24, 2021. The ex-dividend date is August 23, 2021.

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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]).

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"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.