Celldex Therapeutics Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On July 16, 2021 Celldex Therapeutics, Inc. ("Celldex" or the "Company") (Nasdaq: CLDX) reported the closing of its previously announced underwritten public offering of 6,845,238 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase an additional 892,857 shares, at a public offering price of $42.00 per share (Press release, Celldex Therapeutics, JUL 16, 2021, View Source [SID1234584920]). The gross proceeds to Celldex from this offering were approximately $287.5 million, before deducting underwriting discounts and commissions and offering expenses.

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Jefferies, SVB Leerink, Guggenheim Securities and Cantor acted as joint book-running managers for the offering. LifeSci Capital LLC and H.C. Wainwright & Co. acted as co-lead managers for the offering.

The securities described above were offered and sold by Celldex pursuant to a prospectus supplement and an accompanying base prospectus forming part of a shelf registration statement on Form S-3 (File No. 333-249917), which was deemed effective by the Securities and Exchange Commission ("SEC") on November 6, 2020, and are available on the SEC’s website located at View Source Copies of the prospectus supplement and the accompanying base prospectus may be obtained for free by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by e-mail at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105, or by e-mail at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at [email protected].

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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Grit Bio Closes Series A+ Round for its Cell Therapy Oncology Therapies

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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Aluda Pharmaceuticals announces peer-reviewed publication on ALD-R491, an Exosome Release Inhibitor and novel oncology mechanism

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.

Kiromic BioPharma Provides Update on IND Filings on its Off-the-Shelf, Allogeneic CAR-T for Solid Tumors

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

CytRx Corporation Announces Closing of $10 Million Offering to Healthcare-Focused Institutional Investor

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.