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Seelos Therapeutics Raises $10 Million In Private Placement of Senior Secured Convertible Note

On December 14, 2020 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, reported the sale of a $12.0 million senior secured convertible note (the "Note") and shares of Seelos common stock (the "Closing Shares") to investors (the "Investors"), including Lind Global Asset Management II, LLC, an investment fund managed by The Lind Partners, a New York based institutional fund manager and an existing investor in Seelos. Seelos received $10.0 million in gross proceeds (Press release, Apricus Biosciences, DEC 14, 2020, View Source [SID1234572805]).

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Seelos intends to use the proceeds for general corporate purposes and to advance the development of its product candidates.

"This financial commitment from Lind enables us to continue to execute our plans of advancing Seelos’ key programs, including the acute suicidal ideation and behavior trial for SLS-002," said Raj Mehra, Ph.D., Chairman and CEO of Seelos.

The following are some of the key features of the Note:

24-month maturity with a 0% coupon
Repayment of principal in eighteen monthly cash payments beginning in June 2021 equal to the then-outstanding principal amount of the Note, divided by the number of months remaining until the Note’s maturity date
Starting six months after the date of issuance of the Note, convertible at the option of the Investors into shares of Seelos common stock at a fixed conversion price of $1.60 per share
Seelos has the right to prepay without penalty (i) up to 662/3% of the outstanding principal amount of the Note prior to the six-month anniversary of the issuance date of the Note, and (ii) up to the outstanding principal amount of the Note on or after the seven-month anniversary of the issuance date of the Note, subject to an Investor’s right to convert a portion of proposed prepayment amounts into Seelos common stock at $1.60 per share
"Lind is pleased to increase its investment in Seelos at such an important time in their development. Their intranasal Ketamine program, SLS-002, is being studied for acute suicidal ideation and behavior in patients with major depression," said Phillip Valliere, Managing Director at The Lind Partners. "It is a very timely and relevant asset to be developing and we look forward to tracking its progress. We have great confidence in Dr. Raj Mehra and the Seelos team and are thrilled to support their upcoming trials."

The Note and the Closing Shares were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the Note, have not been registered under the Act or applicable state securities laws. Accordingly, the Note, the Closing Shares and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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

About The Lind Partners

The Lind Partners is a New York-based institutional fund manager and leading provider of growth capital to small- and mid-cap companies publicly traded in the US, Australia, Canada and the UK. Lind’s core investment strategy is to provide new growth capital via direct investment with initial investments ranging from US$1 to US$30 million plus follow-ons. Lind also invests in syndicated equity offerings and selectively buys on market. Founded in 2011, Lind has completed more than 100 direct investments totaling over $1 Billion in total value and has an established reputation as a flexible and supportive capital partner to investee companies.

GT Biopharma Submits Application for Uplisting to the NASDAQ Capital Market

On December 14, 2020 GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company’s proprietary NK cell engager (TriKE) technology platform reported that it has submitted an application to uplist its common stock to the NASDAQ Capital Market (Press release, GT Biopharma, DEC 14, 2020, View Source [SID1234572804]).

Anthony Cataldo, CEO and Chairman of GT Biopharma commented, "It is our belief that uplisting to a major exchange will allow a broader base of worldwide institutions, funds and retail investors to participate in our future success. Moreover, with the success of the data most recently presented at the ASH (Free ASH Whitepaper) conference we have received tremendous institutional interest and believe that this transition will increase corporate visibility, improve our stock’s trading liquidity, and broaden awareness of GT Biopharma in the investment community."

Acceptance for listing the Company’s shares is subject to approval and satisfaction of several factors, including minimum listing requirements for the Nasdaq Capital Market. The Company is optimistic that it can satisfy all of the applicable listing requirements, however, there is no assurance that its application will be approved.

Avelas Receives FDA Breakthrough Therapy Designation for Pegloprastide (AVB-620) for Use During Breast Cancer Surgery

On December 14, 2020 Avelas Biosciences, Inc., pioneering the field of intraoperative fluorescent cancer imaging, reported that the company has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for pegloprastide (AVB-620) for the intraoperative detection and visualization of positive margins during breast cancer surgery (Press release, Avelas Biosciences, DEC 14, 2020, View Source [SID1234572803]). Pegloprastide is designed to deliver a fluorescent marker to cancer cells to aid surgeons in identifying positive margins in real time during surgery. Positive margins can be a sign that cancer may be left behind, requiring a second surgery.

"We now have clarity on the development path to make fluorescence image-guided surgery the new standard of care for breast cancer lumpectomies," said Jay Lichter, Ph.D., Chairman, President, and Chief Executive Officer of Avelas. "Pegloprastide has the potential to greatly reduce the number of repeat surgeries, potentially improving outcomes for hundreds of thousands of women and saving thousands of lives."

The presence of positive margins is a significant challenge in breast-conserving surgery. Positive surgical margins occur when post-operative pathology indicates cancer cells are present at or very close to the edge of removed tissue, indicating that there may be residual cancer left behind after an operation. It is estimated that each year in the United States more than 260,000 women undergo a lumpectomy, of which one-third (more than 80,000) are repeat surgeries with the goal of achieving negative margins.1 Beyond that, of the estimated 90,000 women who choose a mastectomy, many choose it for fear of incomplete initial lumpectomy or due to an initial attempt at a lumpectomy that resulted in positive margins.1

The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is under investigation to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints. A Breakthrough Therapy designation provides more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.

Previously reported positive top-line data from the company’s completed Phase 2/3 study, which evaluated the safety and efficacy of pegloprastide in women with primary, nonrecurrent breast cancer undergoing surgery, met its primary endpoint of detecting cancer in margin specimens in real time (p<0.001). The data showed use of pegloprastide during surgery correctly identified cancer in up to 75% of patients who would have otherwise been candidates for a repeat (re-excision) surgery. Observed re-excision rate in the study was 6% in patients whose surgeries included pegloprastide. Current re-excision rates are estimated at 20-40% among all patients receiving an initial lumpectomy. 2-7

About Pegloprastide (AVB-620) and QUEST SPECTRUM Fluorescent Imaging Device

Pegloprastide (AVB-620) is based on the science of activatable cell-penetrating peptides and is the only fluorescence-based clinical cancer detection product that uses the ratio of two fluorophores within the same molecule (ratiometric imaging) to provide more accurate and actionable information. Pegloprastide’s ratiometric readout attenuates common artifacts of fluorescent imaging, including differences in drug concentration and distance of the camera from the tissue area of interest. Pegloprastide is used during surgery with a specialized fluorescent imaging device manufactured for Avelas by Quest Medical Imaging, based on its QUEST SPECTRUM platformtechnology. QUEST SPECTRUM device has a wide field of view and provides a rapid assessment of tissue. Beyond breast cancer, Avelas has plans to explore the use of pegloprastide during surgery for other types of cancer, including ovarian, colorectal, head and neck, melanoma, and sarcoma.

About Quest

Quest Photonic Devices is a group of companies that is developing high-end multispectral imaging cameras and light sources for medical and industrial use. Through its subsidiary companies, Quest Medical Imaging B.V. and Quest Medical Imaging Inc., Quest focuses specifically on the medical market of fluorescence image-guided surgery and is committed to improving patient care and surgical outcomes.

RedHill Biopharma Added to NASDAQ Biotechnology Index

On December 14, 2020 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that the company was selected for addition to the NASDAQ Biotechnology Index (NASDAQ: NBI) (Press release, RedHill Biopharma, DEC 14, 2020, View Source [SID1234572802]). The addition to the NBI will become effective prior to market open on Monday, December 21, 2020.

The Index is used to designate a set of NASDAQ-listed securities to be acquired as part of index-defined funds to be used in investment portfolios. The biotechnology index is classified according to the Industry Classification Benchmark (ICB). Companies in the biotechnology index must meet eligibility requirements, including minimum market capitalization, average daily trading volume, seasoning as a public company, and other criteria. The index is evaluated annually and serves as the basis for the iShares NASDAQ Biotechnology Index Fund.

For more information about the NASDAQ Biotechnology Index, including eligibility criteria, visit View Source

Curis Announces Closing of Public Offering of Common Stock with $169.6 Million in Gross Proceeds, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

On December 14, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported the closing of its underwritten public offering of 29,500,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase up to an additional 3,847,826 shares, at the public offering price of $5.75 per share (the Offering) (Press release, Curis, DEC 14, 2020, View Source [SID1234572801]). Curis expects the net proceeds from the Offering to be approximately $159.1 million, after deducting underwriting discounts and commissions and estimated offering expenses.

Cantor Fitzgerald & Co. and JonesTrading Institutional Services LLC acted as joint book-runners for the Offering. H.C. Wainwright & Co., LLC and Laidlaw & Company (UK) Ltd. acted as co-lead managers.

Curis intends to use the net proceeds from the Offering, together with its existing cash and cash equivalents, to continue development of CA-4948, in collaboration with Aurigene, and CI-8893, in collaboration with ImmuNext, and for general working capital and capital expenditures. Curis estimates that the net proceeds from the Offering, together with its existing cash and cash equivalents, will enable it to fund its operating expenses and capital expenditure requirements into 2023.

The securities in the Offering were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224627) that was filed with the United States Securities and Exchange Commission ("SEC") on May 3, 2018, and declared effective by the SEC on May 17, 2018 and an additional registration statement on Form S-3 (File No. 333-251211) filed pursuant to Rule 462(b) which became automatically effective on December 9, 2020. The offering was made only by a means of a written prospectus and a prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the Offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022 or by email at [email protected].

The securities described above have not been qualified under any state blue sky laws. 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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.