CorMedix Announces Pricing of $20M Public Offering of Common Stock

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.

Aeterna Zentaris Receives Nasdaq Notification Regarding Minimum Bid Price Compliance; No Immediate Impact on Listing

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.

Iterion Therapeutics Initiates Enrollment of Phase 2a Dose Expansion Study of Tegavivint in Patients with Desmoid Tumors

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.

Novocure Announces Recipients of 2nd Annual AACR-Novocure Grants for Tumor Treating Fields Research Program

On July 28, 2020 Novocure (NASDAQ:NVCR) reported the recipients of the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research program (Press release, NovoCure, JUL 28, 2020, View Source [SID1234562473]). The program represents a joint effort between Novocure and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) to promote and support innovative research on Tumor Treating Fields. The AACR (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer.

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Such collaborations help to deepen the understanding of the mechanism of action and to accelerate the development of new treatment strategies. Extensive preclinical and clinical evidence provides the foundation upon which Novocure executes its strategy to advance Tumor Treating Fields through additional clinical research studies across multiple solid tumor types.

"Congratulations to the recipients of the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research," said Asaf Danziger, Novocure’s Chief Executive Officer. "We value our ongoing partnership with the AACR (Free AACR Whitepaper) as we continue to deepen our understanding of the mechanism of action of Tumor Treating Fields. We look forward to learning the outcomes of the impressive research planned by our grant recipients."

"The AACR (Free AACR Whitepaper) is thrilled to welcome its newest class of grant recipients, including the recipients of the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields," said Mitch Stoller, the AACR (Free AACR Whitepaper)’s Chief Philanthropic Officer. "Our continued partnership with Novocure has played a pivotal role in providing crucially needed resources to scientists on the leading edge of discovery. The innovative research supported by these grants will contribute to our understanding of Tumor Treating Fields, and may lead to the identification of new and exciting applications for this emerging technology."

2020 AACR (Free AACR Whitepaper)-Novocure Career Development Awards for Tumor Treating Fields Research

Narasimha Kumar Karanam, Ph.D., University of Texas Southwestern Medical Center
"Harnessing E2F-Rb-CDK4/6 axis for novel combination therapy with TTFields"
Chirag B. Patel, M.D., Ph.D., Stanford University
"Increasing glioblastoma cell membrane permeability with TTFields"
2020 AACR (Free AACR Whitepaper)-Novocure Tumor Treating Fields Research Grants

Carsten Hagemann, Ph.D., Universitätsklinikum Würzburg, Germany
"Overcoming the blood brain barrier drug delivery hurdle with TTFields"
Sandeep Mittal, M.D., FRCSC, FACS, Virginia Polytechnic Institute
"Epigenetic modifications induced by TTFields in patient-derived GBM cells"
Debabrata Saha, Ph.D., University of Texas Southwestern Medical Center
"Evaluating efficacy of TTFields and radiotherapy in preclinical tumor model"
David D. Tran, M.D., Ph.D., University of Florida College of Medicine
"Molecular mechanism of resistance to Tumor Treating Fields in glioblastoma"
Christopher Douglas Willey, M.D., Ph.D., University of Alabama at Birmingham
"Exploring Novo-TTF in advanced patient derived GBM models with multi-omics"

Xencor to Host Second Quarter 2020 Financial Results Webcast and Conference Call on August 4, 2020

On July 28, 2020 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune disease, reported that it will release second quarter 2020 financial results after the market closes on Tuesday, August 4, 2020 (Press release, Xencor, JUL 28, 2020, View Source [SID1234562472]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers and referencing conference ID number 3066174. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 30 days.