On August 15, 2022 Sigyn Therapeutics, Inc. (OTCQB: SIGY), a development-stage company focused on the creation of therapeutic solutions that address unmet needs in global health, reported its financial results for the second quarter ended June 30, 2022 and provides an update on recent corporate developments (Press release, Sigyn Therapeutics, AUG 15, 2022, View Source [SID1234618341]).

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"We continue to take meaningful steps toward our goal to advance Sigyn Therapy into human clinical studies," commented Jim Joyce, co-founder and CEO of Sigyn Therapeutics. "Of particular note was our successful completion of in vivo animal studies, which followed a series of in vitro studies that demonstrated the ability of Sigyn Therapy to isolate and extract pathogen sources of life-threatening inflammation in concert with the broad-spectrum depletion of proinflammatory cytokines from human blood plasma. The data from these studies is being incorporated into an Investigational Device Exemption that we are drafting for submission to the U.S. Food and Drug Administration to support potential human studies of Sigyn Therapy in the United States."

Sigyn Therapy is multi-function blood purification technology designed to treat life-threatening infections and inflammatory disorders that are not addressed with approved drugs. In vitro study validations of pathogen sources of life-threatening inflammation include endotoxin (a gram-negative bacterial toxin), peptidoglycan and lipoteichoic acid (gram-positive bacterial toxins), and viral pathogens, including COVID-19. In vitro study validations of inflammatory cytokines include interleukin-1 beta (IL-1b), interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-a).
Based on these capabilities, the Company believes that Sigyn Therapy is a candidate to treat pathogen-associated sepsis (leading cause of hospital deaths), community acquired pneumonia (a leading cause of death among infectious diseases), emerging pandemic threats, and hyperinflammation & endotoxemia that commonly occurs in end-stage renal disease patients.

Recent 2022 Developments

Reported the successful completion of in vivo animal studies conducted at the University of Michigan.
Appointed accomplished financial executive, Jeremy Ferrell, CPA, MBA as Chief Financial Officer.
Established a Scientific Advisory Board comprised of recognized clinician researchers and thought leaders from the fields of nephrology, neurology, hepatology, and liver transplantation.
On August 3, 2022, announced that its securities had graduated from trading on the OTC Pink Market to the OTCQB Venture Exchange, and confirmed the Company continues to pursue the listing of its securities on a major exchange.
Summary Second Quarter 2022 Financial Results
For the quarter ended June 30, 2022, the Company had a loss from operations of approximately $533,000, compared to an operating loss of approximately $442,000 for the comparable period of 2021. The Company’s net loss for the 2022 second quarter was approximately $666,000, or approximately $0.02 per share, compared to a net loss of approximately $650,000, or approximately $0.02 per share, for the comparable period in 2021. Second quarter 2022 net cash used in operating activities was approximately $395,000.

For complete financial results, please see Sigyn Therapeutics’ filings at www.sec.gov, and on the Company’s website at www.SigynTherapeutics.com under "Financial Info" in the Investors section.

On August 15, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, reported that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission ("SEC") relating to an At-the-Market offering (the "ATM Program") (Press release, Valneva, AUG 15, 2022, View Source [SID1234618340]). Pursuant to this new financing program, the Company may offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $75.0 million of American Depositary Shares ("ADS"), each ADS representing two of the Company’s ordinary shares, from time to time in sales deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, and pursuant to the terms of an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies"), acting as sales agent, subject to French regulatory limits. The timing of any sales will depend on a variety of factors and the Company is not under any obligation to utilize the ATM Program in a specified amount or at all.

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The ADSs intended to be sold under the Sales Agreement, if any, will be issued and sold pursuant to a shelf registration statement on Form F-3 (the "Registration Statement"), once declared effective by the SEC.

To the extent that ADSs are sold pursuant to the ATM Program, the Company currently intends to use the net proceeds (after deduction of fees and expenses), if any, of sales of ADSs issued under the ATM Program, together with its existing cash and cash equivalents, primarily for research and development of the Company’s product candidates, working capital and other general corporate purposes, at the Company’s discretion.

Jefferies, as sales agent, will use commercially reasonable efforts to arrange on the Company’s behalf for the sale of all ADSs requested to be sold by the Company to eligible investors requesting it, consistent with Jefferies’ normal sales and trading practices. Sales prices may vary based on market prices and other factors. Only eligible investors (as described in greater detail below) may purchase ADSs under the ATM Program.

The ADSs and the underlying ordinary shares will be issued through one or more share capital increases without shareholders’ preferential subscription rights under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) and pursuant to and within the limits set forth in the 24th and 28th resolutions adopted by the combined shareholders’ general meeting dated June 23, 2022 (the "General Meeting") (or any substitute resolutions, adopted from time to time), i.e. a maximum number of 30,666,666 ordinary shares (being the maximum authorized by the shareholders for the 24th resolution), representing a maximum potential dilution of approximately 26.1% based on the existing share capital of the Company. In any event the number of underlying ordinary shares to be admitted on the regulated market of Euronext in Paris ("Euronext Paris") shall represent, over a period of 12 months, less than 20% of the ordinary shares already admitted to trading on said market without a French listing prospectus.

The new ordinary shares to be sold in the form of ADSs would be issued in one or more offerings at market prices of the ADSs at the time of pricing of the considered capital increase.

The ATM Program may only be issued to the categories of investors defined in the 24th resolution adopted by the General Meeting (or any similar resolutions that may be substituted for it in the future), comprising (i) natural persons or legal entities, including companies, trusts, investment funds or other investment vehicles, regardless of their form, under French or foreign law, investing on a regular basis in the pharmaceutical, biotechnological or medical technology sector, and/or (ii) French or foreign companies, institutions or entities of any form, carrying out a significant portion of their business in the pharmaceutical, cosmetics or chemical sector or in the field of medical devices and/or technologies or research in these areas. The new ordinary shares will be admitted to trading on the regulated market of Euronext in Paris and the issued ADSs will trade on the Nasdaq Global Select Market ("Nasdaq").

On an illustrative basis, assuming the issuance of the full amount of $75.0 million (or €72.5 million (all convenience translations in this press release are based on an exchange rate of €1.00 = $1.0338, the exchange rate reported by the European Central Bank on August 11, 2022) of ADSs under the ATM Program at an assumed offering price of $20.83 per ADS (or €10.03 per ordinary share), the last reported sale price of the ADSs on Nasdaq on August 11, 2022, a holder of 1.0% of the outstanding Company’s share capital as of the date of this press release, would hold 0.99% of the outstanding Company’s share capital after the completion of the transaction (calculated on the basis of the number of outstanding shares on the date of publication of this press release), it being specified that, in any event, the number of underlying ordinary shares shall not exceed the limit set forth in the 24th resolution adopted by the General Meeting (or any substitute resolutions, adopted from time to time) and shall represent, over a period of 12 months, less than 20% of the ordinary shares already admitted to trading on said market without a listing prospectus.

During the term of the ATM Program, the Company will include information in the publication of its half-year and full-year financial reports about its use of the ATM Program during the preceding period and will also provide an update after each capital increase on a dedicated location on its corporate website in order to inform investors about the main features of each issue that may be completed under the ATM Program from time to time.

The Registration Statement (including a prospectus) relating to Valneva’s securities, including the ADSs, was filed with the SEC on August 12, 2022 but has not yet been declared effective. No offers or sales of ADSs under the ATM Program can be made until the Registration Statement is declared effective by the SEC. Before purchasing ADSs in an offering, prospective investors should read the prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at (877) 821-7388 or by email at [email protected]. No prospectus will be subject to the approval of the French Financial Markets Authority (the Autorité des Marchés Financiers or the "AMF") pursuant to Regulation (EU) 2017/1129 of the European Parliament and of the Council dated June 14, 2017, as amended (the "Prospectus Regulation") since the contemplated share capital increase(s) (for the issuance of the ordinary shares underlying the ADSs) would be offered to qualified investors (as such term is defined in Article 2(e) of the Prospectus Regulation) and fall under the exemption provided for in Article 1(5)(a) of the Prospectus Regulation which states that the obligation to publish a prospectus shall not apply to admission to trading on a regulated market of securities fungible with securities already admitted to trading on the same regulated market, provided that they represent, over a period of 12 months, less than 20% of the number of securities already admitted to trading on the same regulated market.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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. In particular, no public offering of the ADSs will be made in Europe.

Information Available to the Public

Detailed information concerning the Company, in particular with regard to its business, results, forecasts and corresponding risk factors, is provided in the Company’s Annual Report on Form 20-F (the "Annual Report"), filed with the SEC on March 24, 2022, as well as in the half-yearly financial report (containing an update of the main information on the Company, its development and its projects) (the "Half-Year Report"), and documents filed with the SEC from time to time (the "SEC Filings"). The Annual Report and SEC Filings are available on the SEC’s website (www.sec.gov). The Company’s Universal Registration Document filed with the AMF on March 23, 2022 under number D.22-0140 and the Company’s half year report published on its website on August 11, 2022 as well as other regulated information are available on the AMF website (www.amf-france.org). All of the foregoing documents are available on the Company’s website and are available free of charge on request at the Company’s registered office at 6 rue Alain Bombard, 44800 Saint-Herblain, France.

On August 15, 2022 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, AUG 15, 2022, View Source [SID1234618339]).

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The share buy-back program is expected to be completed no later than August 31, 2022 and comprises up to 370,000 shares.

The following transactions were executed under the program from August 8, 2022 to August 12, 2022:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 482,983 shares as treasury shares, corresponding to 0.73% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 22 dated June 17, 2022.

On August 15, 2022 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 June 30, 2022 and provided a clinical update of its anti-cancer drug candidates currently in development for the treatment of primary and metastatic brain and CNS cancer (Press release, CNS Pharmaceuticals, AUG 15, 2022, View Source [SID1234618338]).

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"Within the past 6 months alone, we have executed on a number of clinical and operational advancements including expanding our global presence with clinical approvals in Spain, France and Switzerland to drive patient enrollment forward, as well as expanding eligibility for patients to participate in our potentially pivotal study of Berubicin for the treatment of GBM with our recently amended protocol, which was approved by the FDA, Swissmedic, National Agency for the Safety of Medicine and Health Products (ANSM) Competent Authority and corresponding European ethics committees. Our focus and priorities remain on advancing our clinical development program for Berubicin to ultimately bring a meaningful treatment to GBM patients, families and clinicians, who currently have extremely limited and often ineffective treatment options," commented John Climaco, CEO of CNS Pharmaceuticals.

Clinical Programs Update

Berubicin – Novel anthracycline

CNS’ lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV1) after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival (OS), which is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Results from the trial will compare Berubicin to a current standard of care (Lomustine), with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine. The recently amended protocol expands eligibility for the study to patients who have received additional treatments as part of the first line therapy for their disease considering advancements in this area. This change was made due to the complexity of new agents introduced as a component of first line therapy, which allows an additional group of patients that can enroll on the study after what may constitute multiple procedures as their initial treatment.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

The FDA previously granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

Upcoming Milestones

Continued site initiations across the U.S., Italy, France, Spain, and Switzerland for potentially pivotal study to evaluate efficacy of Berubicin in the treatment of adult GBM;
Regulatory and ethics approval in Italy;
Commencement of patient enrollment across European clinical sites;
Interim analysis of the trial when 30-50% of the total expected patients have been on study for 6 months (expected mid-year 2023); and
Complete enrollment in potentially pivotal clinical trial for GBM.
WP1244 Portfolio – Novel class of DNA-binding agents

The Company continues to advance the development of its WP1244 drug technology portfolio, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. The Company’s development work has produced a new mesylate salt of WP1244, now identified as WP1874. The enhanced solubility of this salt may increase its ability to be formulated for use in an IV infusion, while maintaining similar potency and toxicity characteristics. Going forward, WP1874 will be the primary focus in our development efforts of the WP1244 portfolio. CNS Pharmaceuticals is also evaluating the use of WP1244/WP1874 in the treatment of other primary brain and central nervous system cancers, as well as cancers metastatic to the brain including pancreatic, ovarian, and lymphomas.

Upcoming Milestones

File IND in 2023.
Summary of Financial Results for the Second Quarter 2022

The net loss for the three months ended June 30, 2022 was approximately $3.6 million compared to approximately $3.8 million for the comparable period in 2021. The change in net loss is attributable to decreases in the timing of drug development expenses (significant manufacturing activity occurred in the prior year period with much less occurring in the current year), as well as a credit to research and development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase in contract research organization (CRO) expenses related to continued progress with our Phase 2 clinical trial as well as increases in legal and professional fees and other expenses.

The Company reported research and development expenses of $2.2 million for the three months ended June 30, 2022 compared to approximately $2.7 million for the comparable period in 2021. The decrease in research and development expenses during the period were mainly attributed to the timing of drug development expenses, as well as a credit to research and development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase in CRO expenses related to continued progress with our Phase 2 clinical trial.

General and administrative expense was approximately $1.3 million for the three months ended June 30, 2022 compared to approximately $1.1 million for the comparable period in 2021. This increase in general and administrative expense was mainly attributable to an increase in employee compensation (due to the timing of annual employee incentive compensation) and taxes and legal and professional fees, which were offset with decreases in stock-based compensation and other expenses.

As of June 30, 2022, the Company had cash of approximately $9.0 million and working capital of approximately $10.5 million. The Company’s current expectation is that the cash on hand and the proceeds from the offering during January is sufficient to fund our operations into 2023. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.

On August 15, 2022 Carina Biotech reported that it has raised $7.5 million at first close of its current funding round, welcoming on board new venture capital business Tenmile as the cornerstone investor together with strong support from existing investors (Press release, Carina Biotech, AUG 15, 2022, View Source [SID1234618337]).

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"We are delighted to welcome Tenmile as an investor in Carina Biotech with its commitment to accelerate high impact, cutting edge Australian health technology innovation. We are also pleased that our other shareholders have continued their strong support," said CEO Dr Deborah Rathjen.

The capital raise enables Carina to complete its Investigational New Drug (IND) enabling studies and initiate a CAR-T clinical trial of our LGR5 CAR-T cell for patients with advanced colorectal (bowel) cancer.

"Colorectal cancer is Australia’s second deadliest cancer and its incidence is rising in people under the age of 50. Many younger people are diagnosed at advanced stages of the disease with very poor prognoses. This is a lethal cancer for all Australians, young and old, that we want to be able to treat. CAR-T therapy is currently used for the treatment of blood cancers and it has proved to be curative.

"We are very excited to be able to bring this personalised form of immunotherapy embedded with Carina’s proprietary CAR-T technology to patients with solid cancers," Dr Rathjen further added.

Tenmile Executive Chair, Dr Steve Burnell, said, "Carina represents the kind of investment opportunity Tenmile looks for – advanced novel technology addressing a major unmet medical need, depth of expertise, global networks and strong intellectual property. It also reflects our commitment to using our capital as a force
for good including backing female-led businesses."

Carina is one of Tenmile’s first cohort of investments. Tenmile is the new $250m healthtech venture capital fund backed by Andrew and Nicola Forrest’s Tattarang investment group.

The capital raise also enables Carina to progress its robust pipeline of CAR-T programs and its technology platform which includes Carina’s Chemokine Receptor Platform that is being used to develop CAR-T cells expressing chemokine receptors that drive CAR-T cells to ‘home in’ on specific cancer cells.

Carina’s proprietary manufacturing process shortens the time required for CAR-T cell generation producing higher numbers of highly active CAR-T cells.

Carina’s approach to institutional and impact investors was undertaken by MST Financial. Peter Wilson of wilsonemmett Pty Ltd acted as financial adviser to Carina.