On November 17, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported CEO Snehal Patel will participate in the virtual portion of Jefferies’ Annual London Healthcare Conference held from November 16-19, 2021 (Press release, Greenwich LifeSciences, NOV 17, 2021, View Source [SID1234595727]).

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Jefferies’ Annual London Healthcare Conference

Jefferies’ 12th Annual London Healthcare Conference is the largest healthcare-dedicated conference in Europe. Participation is by invitation only and will feature leading public and private companies from the pharmaceuticals, biotechnology, medical technology, and healthcare services sectors from the Americas, Europe, Middle East, Africa, Asia, and Australia. For more information please visit: Jefferies London Healthcare Conference

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On November 17, 2021 Avenue Therapeutics, Inc. (the "Company") (NASDAQ: ATXI), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, reported that the underwriter of its previously announced underwritten public offering has exercised, in full, its option to purchase an additional 292,018 shares of common stock at a price of $1.34 per share (Press release, Avenue Therapeutics, NOV 17, 2021, View Source [SID1234595743]). Total gross proceeds to the Company from the offering, including the funds received from the prior closing and exercise of this option, are approximately $3 million, before deducting underwriting discounts, commissions, and other offering expenses payable by the Company.

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Aegis Capital Corp. acted as the sole book-running manager for the offering.

The offering was made pursuant to a registration statement on Form S-3 (File No. 333-259850) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A final prospectus and accompanying registration statement relating to the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov.

A copy of the final prospectus and accompanying registration statement relating to the offering may be obtained by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

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.

On November 17, 2021 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need, reported that it has commenced an underwritten public offering of its common stock and pre-funded warrants (Press release, CymaBay Therapeutics, NOV 17, 2021, View Source [SID1234595759]). All shares of common stock and pre-funded warrants to be sold in the offering will be offered by CymaBay. CymaBay intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the number of shares of its common stock offered in the public offering (including shares underlying the pre-funded warrants). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. CymaBay anticipates using the net proceeds from the offering to fund ongoing development of seladelpar and for working capital and general corporate purposes.

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Piper Sandler and Raymond James are acting as the joint book-running managers for the offering.

The securities described above are being offered by CymaBay pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC") on July 2, 2020, which became effective on July 13, 2020. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at 800-747-3924, or by email at [email protected]; or Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, or by e-mail at [email protected].

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

On November 17, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to transform disease management and improve patient outcomes, reported that it has been named in Inc.’s first-annual Best-Led Companies list, a select, data-driven list of the very strongest U.S. firms with revenue of $50 million to $2 billion (Press release, Castle Biosciences, NOV 17, 2021, View Source [SID1234595744]).

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"This inaugural list of companies represents the remarkable midsized companies, both public and private, often founder-led, that are at the vanguard of reinventing American business," says Scott Omelianuk, editor-in-chief of Inc. magazine. "With their leadership, all business will benefit from an exciting, competitive future full of possibilities."

"At Castle, our commitment to improving patients’ lives through innovative diagnostics is what drives us forward; it is a passion that has ignited a strong purpose in our business since our founding," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Being ranked in Inc.’s inaugural Best-Led Companies list is an honor and affirms that we have built our business on a solid foundation that we believe will drive sustainable growth for years to come."

The list recognizes 250 companies that are agile enough to maneuver but also big enough to have a broad impact. These companies employ 35 million people, about one of four U.S. workers. All 250 have a successful track record with leadership teams that spur solid performance, create value, penetrate markets, engage with customers and more.

Applicants were analyzed via an algorithm that identified the strongest companies based on accomplishments in four key areas: performance and value creation; market penetration and customer engagement; talent; and leadership team.

To compile the list, Inc. evaluated private and public U.S.-based companies with a 2020 revenue of $50 million to $2 billion or a valuation of $50 million to $10 billion using a proprietary 14-point measure of management excellence generated with input from partners at Pitchbook and Shango Labs.

To see the complete list, go to: View Source

On November 17, 2021 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported that unaudited financial results for the third quarter of 2021 and provided an update on strategic and operational developments (Press release, EDAP TMS, NOV 17, 2021, View Source [SID1234595795]).

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Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "We are pleased with the continued strong growth in U.S. HIFU treatment volumes, which increased 58% year-to-date over the comparable period in 2020. This is a very positive sign as it reflects the growing adoption of focal therapy by urologists. Regarding our third quarter revenue, the COVID-19 pandemic continued to weigh on hospital capital spending, and this was further impacted by several machine placements that were delayed until the early days of the fourth quarter due to logistical challenges that were exacerbated by the resurgence of the pandemic in many parts of the world. Our leading indicators are strong, we are well financed, and I believe we are well positioned to exit the year with renewed momentum."

Nine Months 2021 Results

Total revenue for the nine months ended September 30, 2021 was EUR 30.1 million (USD 35.9 million), an increase of 14.4% from total revenue of 26.3 million (USD 29.8 million) for the same period in 2020.

Total revenue in the HIFU business for the nine months ended September 30, 2021 was EUR 5.7 million (USD 6.8 million), a decline of 18.9% as compared to EUR 7.1 million (USD 8.0 million) for the nine months ended September 30, 2020.

Total revenue in the LITHO business for the nine months ended September 30, 2021 was EUR 7.7 million (USD 9.1 million), an decrease of 7.4% from EUR 8.3 million (USD 9.4 million) for the nine months ended September 30, 2020.

Total revenue in the Distribution business for the nine months ended September 30, 2021 was EUR 16.7 million (USD 19.9 million), a 52.4% increase compared to EUR 11.0 million (USD 12.4 million) for the nine months ended September 30, 2020.

Gross profit for the nine months ended September 30, 2021 was EUR 12.2 million (USD 14.6 million), compared to EUR 11.4 million (USD 12.8 million) for the year-ago period. Gross profit margin on net sales was 40.6% for the nine months ended September 30, 2021, compared to 43.2% for the comparable period in 2020. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 14.3 million (USD 17.0 million) for the nine months ended September 30, 2021, compared to EUR 12.8 million (USD 14.5 million) for the same period in 2020.

Operating loss for the nine months ended September 30, 2021 was EUR 2.1 million (USD 2.5 million), compared to an operating loss of EUR 1.5 million (USD 1.6 million) for the nine months ended September 30, 2020.

Net loss for the nine months ended September 30, 2021 was EUR 0.7 million (USD 0.8 million), or EUR (0.02) per diluted share, as compared to a net loss of EUR 2.5 million (USD 2.8 million), or EUR (0.09) per diluted share in the year-ago period.

Third Quarter 2021 Results

Total revenue for the third quarter 2021 was EUR 9.4 million (USD 11.1 million), roughly flat with total revenue of EUR 9.4 million (USD 11.2 million) for the same period in 2020.

Total revenue in the HIFU business for the third quarter 2021 was EUR 1.9 million (USD 2.3 million), a decline of 25.6% as compared to EUR 2.6 million (USD 3.0 million) for the third quarter of 2020.

Total revenue in the LITHO business for the third quarter 2021 was EUR 2.5 million (USD 2.9 million), an increase of 3.0% from EUR 2.4 million (USD 2.9 million) for the third quarter of 2020.

Total revenue in the Distribution business for the third quarter 2021 was EUR 5.0 million (USD 5.9 million), a 13.4% increase compared to EUR 4.4 million (USD 5.2 million) for the third quarter of 2020.

Gross profit for the third quarter 2021 was EUR 3.6 million (USD 4.3 million), compared to EUR 4.0 million (USD 4.7 million) for the year-ago period. Gross profit margin on net sales was 38.4% in the third quarter of 2021, compared to 42.0% in the year-ago period. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 5.5 million (USD 6.5 million) for the third quarter of 2021, compared to EUR 4.3 million (USD 5.0 million) for the same period in 2020.

Operating loss for the third quarter of 2021 was EUR 1.9 million (USD 2.2 million), compared to an operating loss of EUR 0.3 million (USD 0.3 million) in the third quarter of 2020.

Net loss for the third quarter of 2021 was EUR 1.0 million (USD 1.2 million), or EUR (0.03) per diluted share, as compared to a net loss of EUR 1.0 million (USD 1.2 million), or EUR (0.03) per diluted share in the year-ago period.

As of September 30, 2021, the company held cash and cash equivalents of EUR 45.4 million (USD $52.6 million), as compared to EUR 24.7 million (USD 30.2 million) as of December 31, 2020.

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT tomorrow, November 18, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."