On May 15, 2023 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, reported financial results for the first quarter ended March 31, 2023 and provided an update on recent business developments (Press release, CorMedix, MAY 15, 2023, View Source [SID1234631711]).

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Recent Corporate Highlights:

● As previously guided, CorMedix is resubmitting its DefenCath New Drug Application, or NDA, to the U.S. Food and Drug Administration ("FDA"). The Company anticipates that the NDA will be classified as a Type 2 resubmission with a 6-month review cycle with a target action date in November.

● The Company also recently announced that the US Patent & Trademark office has issued a notice of allowance of patent claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This newly allowed U.S. Patent Application reflects the unique and proprietary nature of DefenCath, and will extend our current intellectual property protection to an anticipated expiration date in 2042.

● CorMedix recently announced that following our submission of a duplicate New Technology Add-On Payment, or NTAP, application to the Centers for Medicare & Medicaid Services, CMS has issued the Inpatient Prospective Payment System 2024 proposed rule that includes an NTAP of up to $17,111 per hospital stay for DefenCath. This NTAP is conditioned upon the DefenCath NDA obtaining final FDA approval prior to July 1, 2024.

● Cash and short-term investments, excluding restricted cash, at March 31, 2023 amounted to $55.6 million.

Joe Todisco, CorMedix CEO, commented, "we are excited to announce today that our DefenCath NDA is ready to be resubmitted to FDA. The resubmission reflects the hard work of the CorMedix regulatory and technical teams and our strategic partners, and we will now increase our focus on preparations for a potential commercial launch in early 2024. We look forward to providing additional updates as we progress toward potential approval in 2023 and aim to deliver on our commitment to reducing the risk of infections in patients receiving hemodialysis via central venous catheters."

First Quarter 2023 Financial Highlights

For the first quarter of 2023, CorMedix recorded a net loss of $10.6 million, or $0.24 per share, compared with a net loss of $7.0 million, or $0.18 per share, in the first quarter of 2022, an increase of $3.5 million, driven primarily by an increase in operating expenses.

Operating expenses in the first quarter 2023 were $11.0 million, compared with $7.0 million in the first quarter of 2022, an increase of approximately 57%. The increase was driven by higher SG&A expenses which increased approximately 60% to $7.6 million, primarily driven by costs related to market research studies and pre-launch activities in preparation for the potential approval of DefenCath, and an increase in personnel expenses and non-cash charges for stock-based compensation. R&D expenses also increased by 49% to $3.4 million, primarily due to net increases in personnel expenses and non-cash charges for stock-based compensation. Additionally, there were also increases in medical affairs activities in preparation for the potential marketing approval of DefenCath and costs related to the manufacturing of DefenCath prior to its potential marketing approval.

The Company reported cash and short-term investments of $55.6 million at March 31, 2023, excluding restricted cash. The Company believes that it has sufficient resources to fund operations at least through the first half of 2024.

On May 15, 2023 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported financial results for the first quarter ended March 31, 2023 and provided a corporate update on key events since the start of 2023 (Press release, Compugen, MAY 15, 2023, View Source [SID1234631710]).

"I am excited that we are leading the way with a unique triple combination immuno-oncology approach with potential to be the next generation of immunotherapies in a very large market with high unmet need", said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "We have already shown preliminary clinical benefit in two tumor types, typically not responding to immunotherapy, microsatellite stable colorectal cancer and platinum resistant ovarian cancer. To confirm this signal, we have initiated two proof-of-concept studies evaluating the triple blockade of PVRIG, TIGIT and PD-1 with COM701, COM902 and pembrolizumab in these indications and are on track to report initial findings by the end of the year. We believe this strategy provides the fastest route in building a path to registration and de-risk our lead assets, COM701 and COM902."

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Dr. Cohen-Dayag continued, "We continue to feed our own pipeline by leveraging our pioneering computational discovery platform. We presented new data on our lead pre-clinical asset, COM503, in an oral presentation at the recent CIMT (Free CIMT Whitepaper) annual meeting. COM503 is a differentiated, novel anti-IL-18BP antibody based approach to harness cytokine biology for anti-cancer therapeutics. By freeing the body’s own interleukin-18 to stimulate the immune system to fight cancer at the tumor site, COM503 has the potential advantage of avoiding the typical systemic toxicity associated with cytokine therapeutics".

Dr. Cohen-Dayag concluded, "We are driven by our strong belief in the potential of our differentiated assets, internal and partnered, and the opportunity to transform the lives of patients with cancer. Our $74.3 million cash balance as of March 31, 2023 re-affirms our financial discipline, with bold execution on our DNAM-1 axis hypothesis and our newly disclosed lead pre-clinical asset advancing towards IND submission next year. We have cash runway at least through the end of 2024, to support operations, reach milestones and de-risk our lead clinical assets, COM701 and COM902."

Financial Results
As of March 31, 2023, cash, cash equivalents, short-term bank deposits and restricted cash totalled approximately $74.3 million, compared with approximately $83.7 million as of December 31, 2022. The Company expects its existing cash and cash related balances to be sufficient to fund its operations at least through the end of 2024, based on its current plans.

Compugen does not have any debt.

R&D expenses for the first quarter of 2023, were approximately $7.4 million compared with approximately $7.2 million for the comparable period in 2022.

General and administrative expenses for the first quarter of 2023, were approximately $2.6 million, compared with approximately $2.6 million for the comparable period in 2022.

Net loss for the first quarter of 2023, was approximately $9.3 million, or $0.11 per basic and diluted share, compared with a net loss of approximately $9.7 million, or $0.11 per basic and diluted share, in the first quarter of 2022.

Full financial tables are included below.

Conference Call and Webcast Information
The Company will hold a conference call today, May 15, 2023, at 8:30 AM ET to review its first quarter 2023 results. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link. Following the live webcast, a replay will be available on the Company’s website.

On May 15, 2023, Coherus BioSciences, Inc. (the "Company") reported to have reduced the amount of shares that could be issued and sold pursuant to its "at-the-market" program ("ATM") with Cowen and Company, LLC ("Cowen") in an amount equal to $86.25 million (Filing, Coherus Biosciences, MAY 15, 2023, View Source [SID1234631709]). The reduction in the amount of shares that can be issued and sold under the ATM was effected pursuant to the Amendment No. 1 to Sales Agreement ("Amendment No. 1"), which amended the Company’s Sales Agreement with Cowen, dated November 8, 2022 (the "Agreement"), to reduce the aggregate offering price under the Agreement from $150.0 million to $63.75 million.

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The foregoing description of Amendment No. 1 is not a complete description thereof, and is qualified in its entirety by reference to the full text of the Amendment No. 1, which will be filed with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2023.

On May 15, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that it has commenced an underwritten public offering of $50.0 million of shares of its common stock (Press release, Coherus Biosciences, MAY 15, 2023, View Source [SID1234631708]). In addition, Coherus expects to grant the underwriters a 30-day option to purchase up to an additional $7.5 million of shares of its common stock at the public offering price, less the underwriting discount. All of the shares of common stock to be sold in the offering will be offered by Coherus. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

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Coherus intends to use substantially all of the net proceeds from this offering for general corporate purposes, including the cost of manufacturing clinical and commercial supplies of product candidates and products. Coherus may also use a portion of the net proceeds from this offering, together with existing cash, cash equivalents and marketable securities, to in-license, acquire or invest in complementary businesses, technologies, products or assets. If there are any remaining net proceeds from this offering, Coherus intends to use them for working capital and other general corporate purposes.

J.P. Morgan and Citigroup will act as co-lead book-running managers for the offering. Mizuho will act as lead manager for the offering.

A shelf registration statement (including a base prospectus) relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on November 17, 2022. This offering may be made solely by means of a prospectus supplement and the accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, electronic copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: (866) 803-9204, email: [email protected] or Citigroup Global Markets Inc. c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: (800) 831-9146.

This press release shall not constitute an offer to sell or a 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 May 15, 2023 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported its financial results for the quarter ended March 31, 2023 and provided a clinical update of its anti-cancer drug candidate currently in development for the treatment of primary and metastatic brain and CNS cancer (Press release, CNS Pharmaceuticals, MAY 15, 2023, View Source [SID1234631707]).

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"Over the course of the first quarter, our team has continued its flawless operational execution of our potentially pivotal study witnessed by our recent enrollment update boasting 100 patients now dosed in this global clinical trial. Importantly, we continue to plan for success as we approach our highly anticipated interim analysis for our ongoing Berubicin trial for GBM, expected in the third quarter of this year. In addition to the tremendous progress we have achieved on the clinical front, we significantly bolstered our Board of Directors with deep industry expertise with the appointments of Faith Charles as Chair and most recently, Dr. Bettina Cockroft as an independent director," commented John Climaco, CEO of CNS Pharmaceuticals. "We remain vigilant in our committment to all stakeholders, especially providing a much-needed potential treatment option for the GBM community."

Recent Corporate Highlights

· Appointed Bettina M. Cockroft, M.D., M.B.A., to Board of Directors, bringing over 30 years of significant biopharmaceutical industry experience and proven clinical development and operational expertise across multiple therapeutic disciplines worldwide.
· Appointed Faith L. Charles, JD as Chair of the Board of Directors, bringing over 30 years of deep life sciences industry experience with a wide range of expertise in corporate governance, capital markets, licensing and strategic collaborations.

Recent Clinical Achievements

· Announced enrollment of over 100 patients; The Company has opened 45 clinical trial sites of the 60 sites selected across the U.S., Italy, France, Spain, and Switzerland.
· Received approval from Competent Authority and Central Ethics Committee in Italy for GBM potentially pivotal study.
· Enrolled first patients in Switzerland and Spain.

Upcoming Expected Milestones

· Report results of interim analysis of potentially pivotal trial of Berubicin expected during the third quarter of 2023.
· Complete enrollment in potentially pivotal clinical trial for GBM.
· Report topline results.

Summary of Financial Results for the First Quarter 2023

The net loss for the three months ended March 31, 2023 was approximately $4.9 million compared to approximately $3.2 million for the comparable period in 2022. The change in net loss is primarily attributable to an increase in research organization ("CRO") expenses related to continued progress with the Company’s potentially pivotal clinical trial of Berubicin, a credit to research and development expense in the prior year period for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, as well as increases in legal and professional fees and other expenses.

The Company reported research and development expenses of $3.6 million for the three months ended March 31, 2023 compared to approximately $1.9 million for the comparable period in 2022. The increase in research and development expenses during the period were mainly attributed to the timing of CRO expenses related to continued progress with the Company’s potentially pivotal clinical trial of Berubicin.

General and administrative expense was approximately $1.4 million for the three months ended March 31, 2023 compared to approximately $1.3 million for the comparable period in 2022. The increase in general and administrative expense was mainly attributable to increases of approximately $75,000 for legal and professional expenses, $37,000 in advertising and marketing, $18,000 in board compensation, $19,000 in travel expenses and $15,000 in other expenses, which were offset by an decrease of approximately $47,000 in stock compensation and $18,000 in insurance expenses.

As of March 31, 2023, the Company had cash of approximately $5.1 million and working capital of approximately $3.0 million.

Subsequent to March 31, 2023, the Company:

· Issued 659,677 shares of common stock under its At-The-Market ("ATM") facility for net proceeds of $1,969,107 (an average price $3.08 per share before a 3% fee to the agent); and
· Had 238,958 Investor Warrants (exercisable into one share of common stock at a price per share of $3.03) exercised by investors in the financing completed on November 30, 2022 for net proceeds of $724,043.

The Company’s current expectation is that the cash on hand, including the issuances subsequent to the first quarter, is sufficient to fund operations beyond the interim analysis and into the fourth quarter of 2023.