On July 28, 2020, BioXcel Therapeutics, Inc. (the "Company") reported that it entered into an underwriting agreement (the "Underwriting Agreement") with BofA Securities, Inc., as representative of the several underwriters named therein (collectively, the "Underwriters") and the selling stockholders named therein (collectively, the "Selling Stockholders"), in connection with the issuance and sale by the Company in a public offering of 4,000,000 shares of the Company’s common stock at a public offering price of $50.00 per share, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3ASR (Registration No. 333-240118) and a related prospectus supplement filed with the Securities and Exchange Commission (the "SEC") (Filing, 8-K, BioXcel Therapeutics, JUL 28, 2020, View Source [SID1234562646]). Under the terms of the Underwriting Agreement, the Selling Stockholders have also granted the Underwriters an option exercisable for 30 days to purchase up to an additional 600,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The Company will not receive any of the proceeds from any sale of shares in the offering by the Selling Stockholders.

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The Company received net proceeds from the offering of approximately $187.5 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company intends to use the net proceeds of the offering to fund ongoing clinical trials, commercialization preparation and for general corporate purposes.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company and the Selling Stockholders, customary conditions to closing, indemnification obligations of the Company, the Selling Stockholders and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

The foregoing description of the Underwriting Agreement is not complete and is qualified in its entirety by reference to the full text of the Underwriting Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Latham & Watkins LLP, counsel to the Company, has issued an opinion to the Company, dated July 31, 2020, regarding the validity of the shares to be issued and sold in the offering. A copy of the opinion is filed as Exhibit 5.1 to this Current Report on Form 8-K.

Based on the planned use of proceeds from the offering, the Company believes that the net proceeds from the offering and its existing cash and cash equivalents will be sufficient to enable it to fund operating expenses and capital expenditure requirements through 2022. The Company has based this estimate on assumptions that may prove to be incorrect, and could utilize available capital resources sooner than currently expected. The amounts and timing of the Company’s actual expenditures will depend on numerous factors, including the progress of the Company’s clinical trials and other development efforts and other factors, as well as the amount of cash used in the Company’s operations.

On July 28, 2020 NeuPharma, a Suzhou biopharma, reported that dosed the first patient in a Phase II trial of RX108 in patients of recurrent/metastatic head and neck squamous cell carcinoma (Press release, NeuPharma, JUL 28, 2020, View Source [SID1234562538]). RX108 is a novel small-molecule inhibitor that targets sodium-potassium adenosine triphosphatase (Na + /K + -ATPase), an important signal transducer and ion transporter. Currently, RX108 is in multiple clinical trials in China and the US for several different types of tumors. Neupharma is developing four molecules for oncology and one for neurodegeneration.

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On July 28, 2020 CorMedix Inc. (NYSE American: CRMD) (the "Company"), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that it has priced its underwritten public offering of 4,444,444 shares of its common stock at $4.50 per share for total gross proceeds, before underwriting commissions and estimated expenses, of approximately $20 million (Press release, CorMedix, JUL 28, 2020, View Source [SID1234562516]). In connection with the offering, the Company granted the underwriters a 30-day option to purchase up to an additional 666,666 shares of common stock. The offering is expected to close on July 30, 2020, subject to customary closing conditions.

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The Company plans to use the net proceeds for general corporate purposes, including obtaining regulatory approval and commercialization of Defencath in the U.S., research and development, and working capital and capital expenditures.

SunTrust Robinson Humphrey and JMP Securities are acting as joint book-running managers for the offering.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus. Copies of the prospectus supplement and accompanying base prospectus relating to the offering may be obtained from SunTrust Robinson Humphrey, Inc., 3333 Peachtree Road NE, 9th Floor, Atlanta, GA 30326, Attn: Prospectus Department, Email: [email protected]; or JMP Securities LLC, 600 Montgomery Street, Suite 1100, San Francisco, CA 94111, Attn: Prospectus Department, Email: [email protected]. An electronic copy of the prospectus supplement and accompanying base prospectus relating to the offering will also be available on the website of the SEC at www.sec.gov.

This press release does 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 jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On July 28, 2020 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna Zentaris" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, reported that on July 27, 2020, the Company received notice from the Listing Qualifications Department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") indicating that, based upon a closing bid price of less than $1.00 per share for the Company’s common stock for the prior 30 consecutive business day period, the Company no longer satisfies Nasdaq Listing Rule 5550(a)(2) (the "Rule") (Press release, AEterna Zentaris, JUL 28, 2020, View Source [SID1234562498]).

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In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided a grace period of 180 calendar days, through January 25, 2021, to evidence compliance with the Rule. To evidence compliance with the Rule, the Company must evidence a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days, but generally not more than 20 consecutive business days, on or before January 25, 2021. In the event the Company does not timely evidence compliance with the Rule, the Company may be eligible for an additional 180-day grace period or may face delisting. In the latter case, the Company would be entitled to request a hearing before the Nasdaq Hearings Panel, which request would stay any delisting action by the Staff pending completion of the hearing process.

Nasdaq’s notice has no immediate effect on the listing of the Company’s common shares on Nasdaq and does not otherwise impact the Company’s listing on the Toronto Stock Exchange. The Company is considering the options available to it to evidence compliance with the Rule prior to the expiration of the grace period.

In addition, as previously disclosed via Form 6-K filed with the Securities and Exchange Commission on July 1, 2020, Aeterna Zentaris priced an approximate $12 million public offering of its common stock and warrants, pursuant to which the Company ultimately raised approximately $10.5 million in net proceeds.

As a result of the offering, the Company believes it has stockholders’ equity of at least $2.5 million as of the date of this filing and thereby satisfies the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(3). The Company is awaiting Nasdaq’s formal confirmation of such compliance and will provide additional disclosure upon receipt of a compliance determination from the Staff.

On July 28, 2020 Iterion Therapeutics, Inc., a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, reported that enrollment has commenced in its multicenter Phase 2a dose expansion clinical study of Tegavivint, a novel, potent and selective nuclear β-catenin inhibitor, in patients with desmoid tumors (Press release, Iterion Therapeutics, JUL 28, 2020, View Source [SID1234562476]). The Phase 2a trial builds on a recently completed open-label, non-randomized Phase 1 study that established safety and initial clinical efficacy of Tegavivint in patients with progressive desmoid tumors.

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Nuclear β-catenin is a highly-studied oncology target associated with numerous cancer types. Tegavivint is unique among nuclear β-catenin inhibitors in that it binds to TBL1 (Transducin βeta-like Protein One), a novel downstream target in the Wnt-signaling pathway. As such, Tegavivint enables silencing of Wnt-pathway gene expression without affecting other Wnt/β-catenin functions in the cell membrane, thus avoiding toxicity issues common to other drugs in this pathway.

Desmoid tumors are rare, non- metastasizing sarcomas that overexpress nuclear β-catenin. An estimated 1,500 patients in the US are newly diagnosed with desmoid tumors each year. Desmoids are most commonly diagnosed in young adults between 30-40 years of age and are associated with significant morbidities, including severe pain, disfigurement, internal bleeding and organ damage, range of motion loss and, in rare cases, death. Iterion has received Orphan Drug Designation for Tegavivint to treat desmoid tumors, a disease for which there are no FDA approved therapies.

"We are very pleased to advance the clinical development of Tegavivint in desmoid tumors as this disease target is greatly underserved and provides an optimal indication for demonstrating the drug’s safety and potential clinical utility in multiple cancer settings," said Rahul Aras, CEO of Iterion. "Desmoid tumors are driven primarily by nuclear β-catenin signaling, a historically ‘undruggable’ oncology target implicated in cell proliferation, differentiation and immune evasion. Efforts to develop inhibitors of β-catenin through drugging upstream targets in the Wnt-signaling pathway have been plagued by toxicity issues, greatly limiting their therapeutic use. Research suggests that these toxicity concerns can be negated by targeting TBL1, a novel downstream target necessary for β-catenin’s oncogenic activity. Our development plan for Tegavivint is to advance its development in desmoid tumors as a launching point for additional programs in acute myeloid leukemia, non-small cell lung cancer, and certain pediatric cancers for which nuclear β-catenin signaling has been identified as a potential therapeutic target."

The Phase 2a trial in desmoid tumors is expected to enroll up to 25 patients who will be treated with the recommended Phase 2 Dose (RP2D), which was established based on pharmacokinetic exposure levels and clinical responses in the recently completed Phase 1 study.

In addition to desmoid tumors, Iterion is preparing to initiate clinical programs to investigate Tegavivint in acute myeloid leukemia (AML), non-small cell lung cancer (NSCLC), and pediatric cancers, including sarcomas, lymphoma and other solid tumors. These cancers are often characterized by nuclear β-catenin overexpression, providing potential high-value target expansions for Tegavivint. The RP2D established in the desmoid tumor program is expected to be utilized in the planning and execution of the clinical trials in these additional indications, offering the potential to expedite the advancement of the individual clinical studies.