On July 16, 2021 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported the closing of its previously announced sale of its securities pursuant to a securities purchase agreement (the "Purchase Agreement") to a single healthcare-focused institutional investor (the "Investor") for aggregate gross proceeds of approximately $10 million (Press release, CytRx, JUL 16, 2021, View Source [SID1234584911]). The Investor is independent of the Company’s Board of Directors and management team. The Company intends to use the net proceeds of the offering for working capital purposes.

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Under the terms of the Purchase Agreement, CytRx sold 2,000,000 shares of its common stock at a purchase price of $0.88 per share for total gross proceeds of approximately $1.76 million in a registered direct offering and 8,240 shares of Series C 10.00% Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share for total gross proceeds of approximately $8.24 million, in a concurrent private placement. The shares of the Preferred Stock are convertible, upon shareholder approval as described below, into an aggregate of up to 9,363,637 shares of common stock at a conversion price of $0.88 per share. The Preferred Stock includes beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99% of the Company’s outstanding shares of common stock.

CytRx also issued to the Investor an unregistered preferred investment option (the "Investment Option") that allows for the purchase of up to 11,363,637 shares of common stock for additional gross proceeds of approximately $10 million if the Investment Option is exercised in full. The exercise price for the Investment Option is $0.88 per share. The Investment Option has a term equal to five and one-half years commencing upon the Company increasing its authorized common stock following shareholder approval (the "Authorized Share Increase").

H.C. Wainwright & Co. acted as exclusive placement agent for the offering.

As described above, the issuance of the shares of common stock underlying the Preferred Stock and the Investment Option sold in the private placement is subject to the Authorized Share Increase. Pursuant to the Purchase Agreement, the Company must hold a meeting of its stockholders no later than September 25, 2021 to seek shareholder approval.

The shares of common stock sold in the registered direct offering were offered and sold in the registered direct offering by CytRx pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255431), including a base prospectus, previously filed with, and declared effective by the Securities and Exchange Commission (the "SEC") on July 12, 2021. The registered direct offering was made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering has been filed with the SEC and is available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained from H.C. Wainwright & Co., 430 Park Avenue, New York, NY 10022 or via telephone at (212) 856-5711 or email at [email protected].

The Series C Preferred Stock and Investment Options sold in the private placement and the shares of common stock issuable thereunder were offered pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and have not been registered under the Act, or applicable state securities laws, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 16, 2021 Kiromic BioPharma, Inc. (Nasdaq: KRBP) reported that Two INDs were submitted to the FDA in May 2021 for the first-in-human off-the-shelf allogeneic CAR-T for Solid Tumors (Press release, Kiromic, JUL 16, 2021, View Source [SID1234584912]).

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FDA returned with comments on the Company’s allogeneic CAR-T products with respect to:

— Tracing of all reagents used in manufacturing

— Flow chart of manufacturing processes

— Certificate of Analysis (COA) for the Company’s CAR-T products (allogeneic CAR-T)

The company has an FDA response taskforce, staffed with 30 yr industry veterans, working on answering the FDA comments above.

Our CMC processes are rigorous.

Our product is allogeneic gamma delta T cell manufacturing which few companies have mastered.

The company’s timeline for commencement of the dosing of its first in human clinical trial is expected to be tighter but we still plan on delivering in 3Q 2021.

June 2, 2021, Kiromic announces the closing of public offering

On July 16, 2021 Aluda Pharmaceuticals, a private company, reported the publication of an article in a peer reviewed journal describing a novel mechanism of Exosome Release Inhibition (ExoRI) for the treatment of a broad range of cancers (Press release, Aluda Pharmaceuticals, JUL 16, 2021, View Source [SID1234584913]). Over the past decade, tumor exosomes have been studied extensively in academia for their roles carrying signals that make tumors invasive, create a tumor microenvironment (TME) that enables evasion from immune detection, and promote metastases . Tumor cells upregulate their release of exosomes to promote these roles throughout all stages of cancer, across many types of cancers, transporting multiple pro-cancer signals, many of which are existing drug targets. Inhibition represents a way to block many signals at once, even as they change over time. Research has shown that PD-L/PD-L1, the important immune checkpoint targets, avoid detection by their transport in exosomes, so exosome inhibitors may also address the large rate of non-response for that class of agents.

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Aluda’s paper, entitled A Small Vimentin-Binding Molecule Blocks Cancer Exosome Release and Reduces Cancer Cell Mobility, appears in the journal Frontiers in Pharmacology, and describes the exosome release inhibition action of ALD-R491 through multiple in vitro models. Further in studies with ALD-R491 show exosome-driven tissue changes consistent with diminished signaling and a lowered TME.

The essential role of vimentin in enabling exosome movement was discovered by Aluda.

Aluda CEO Dr. Ruihuan Chen said, "These results show exosome inhibition can block the messages sent by tumors to drive metastases, reduce the TME, and increase systemic dysregulation. It enables tumors to be detected and attacked by native immunity, and is a non-cytotoxic mechanism that is oral so we expect exosome release inhibition (ExoRI) will be an effective, safe, and patient-friendly anti-cancer therapy with new and significant benefits to patients, and complementarity to existing drugs."

About ALD-R491

ALD-R491 is an intracellular protein that forms dynamic and flexible filaments which play an essential role in disease to mobilize, become invasive, and activate process, including the release of tumor exosomes. Many different types of diseases, from autoimmune and fibrosis to cancer, rely on vimentin filaments for these steps. ALD-R491 binds to a specific domain on vimentin, changing its physical properties and interrupting its role in disease. As a first-in-class "vimentin binder", ALD-R491 showed wide efficacy against disease. ALD-R491 has completed all IND filing requirements including complete two-species GLP tox.

On July 16, 2021 Grit Biotechnology, a two-year-old Shanghai cell therapy company, reported that it closed a Series A+ round to develop its Tumor Infiltrating Lymphocytes (TIL) therapies (Press release, Grit Bio, JUL 16, 2021, View Source [SID1234584915]). Its leading program is GT101, a genetically unmodified TIL product that is currently being tested at a multi-centered clinical trial in China for solid malignancy indications. The round was led by GL Ventures, the VC arm of Hillhouse Group, with participation from Apricot Capital and Junshi Bio, as well as continued support from existing shareholders, Decheng Capital and Matrix Partners.

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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.