On May 9, 2022 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it has entered into a definitive agreement with a single leading healthcare investor for the purchase and sale of 10,563,380 of the Company’s American Depositary Shares ("ADSs") (or ADS equivalents), each ADS representing ten (10) ordinary shares, at a purchase price of $1.42 per ADS (or ADS equivalent), in a registered direct offering (Press release, RedHill Biopharma, MAY 9, 2022, View Source [SID1234613885]). RedHill has also agreed to issue to the investor unregistered private warrants to purchase up to an aggregate of 13,204,225 ADSs in a concurrent private placement. The warrants have an exercise price of $1.48 per ADS, are exercisable six months after the issuance date and have a term of five and one-half years. The closing of the offering is expected to occur on or about May 11, 2022, subject to the satisfaction of customary closing conditions.

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Cantor Fitzgerald & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $15 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital, acquisitions, and general corporate purposes.

The securities described above (but not the warrants or the ADSs underlying the warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form F-3 (File No 333-258259) previously filed with the Securities and Exchange Commission (the "SEC") on July 29, 2021, and declared effective by the SEC on August 9, 2021. The offering of the securities is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at [email protected].

The warrants described above 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 ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs 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 shall not constitute an offer to sell or a 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.

On May 9, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported the acceptance of a poster presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, to be held in-person on June 3-7, 2022, in Chicago, Illinois (Press release, Delcath Systems, MAY 9, 2022, View Source [SID1234613884]).

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Title: FOCUS Phase 3 Trial Results: Percutaneous Hepatic Perfusion (PHP) With Melphalan for Patients With Ocular Melanoma Liver Metastases (PHP-OCM-301/301A)
Session Title: Melanoma/Skin Cancers
Session Date and Time: June 6, 2022, 1:15-4:15 PM CDT (Display) and 4:30-6:30 PM CDT (Discussion)
Abstract Number: 9510
Presenter: Dr. Jonathan Zager, Director of Regional Therapies and Chief Academic Officer, Moffitt Cancer Center; Professor and Chair, Department of Oncologic Sciences, USF Morsani School of Medicine

For more information, visit the ASCO (Free ASCO Whitepaper) Annual Meeting website.

The poster will be available at View Source when the ASCO (Free ASCO Whitepaper) embargo is released on May 26, 2022, at 4:00 PM CDT.

On May 09, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported that its board of directors has authorized a share repurchase program to acquire up to $1 million of the Company’s common stock (Press release, Immix Biopharma, MAY 9, 2022, View Source [SID1234613883]). The Company may purchase common stock on the open market, through privately negotiated transactions, or otherwise, in compliance with the rules of the United States Securities and Exchange Commission and other applicable legal requirements. As of December 31, 2021, the Company had approximately $18 million of cash, cash equivalents and marketable securities. The Company had approximately 13.9 million shares of common stock outstanding as of April 15, 2022.

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"We are confident that with the $24.2 million gross proceeds raised in our recent IPO, ImmixBio is sufficiently capitalized to reach what we believe will be 2 upcoming inflection points: clinical data from IMX-110 monotherapy clinical trial, as well as clinical data from the IMX-110 combined with BeiGene anti-PD-1 tislelizumab clinical trial," said Ilya Rachman, MD PhD, CEO of ImmixBio. "The current market situation allows us to capture additional value for all shareholders through this measured buyback program. Our interests have always been, and continue to be, aligned with all IMMX shareholders."

The timing, amount of shares repurchased and prices paid for the stock under this program will depend on market conditions as well as corporate and regulatory limitations, including blackout period restrictions. The repurchase program does not obligate the Company to acquire any particular amount of shares, and the repurchase program may be suspended or discontinued at any time at the Company’s discretion.

On May 9, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that the first participant has been treated in an investigator-sponsored Phase 1/2 study of bomedemstat in combination with atezolizumab (Tencentriq) during the maintenance phase of treatment in people newly diagnosed with extensive stage small cell lung cancer (ES-SCLC) (Press release, Imago BioSciences, MAY 9, 2022, View Source [SID1234613882]).

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The study is being conducted in Seattle and led by Rafael Santana-Davila, M.D., associate professor at the University of Washington School of Medicine and Joseph Hiatt, M.D., Ph.D., of Fred Hutchinson Cancer Center ("Fred Hutch"), and in collaboration with the National Cancer Institute (NCI) funded Fred Hutch Lung Specialized Project of Research Excellence.

Bomedemstat is an inhibitor of lysine-specific demethylase 1 (LSD1), an enzyme that plays a central role in cell growth. Atezolizumab is an anti-PD-L1 monoclonal antibody medication approved by the U.S. Food and Drug Administration (FDA) in 2021 as adjuvant treatment for non-small cell lung cancer. The Phase 1/2 open-label study will enroll approximately 34 participants diagnosed with ES-SCLC to establish the safety and tolerability of a combination treatment with bomedemstat and atezolizumab. Treatment cycles will last for 21 days, consisting of an oral administration of bomedemstat once daily and intravenous administration of atezolizumab on day 1. Participants are followed up after 30 days and every 12 weeks thereafter.

"We are excited to work with UW Medicine and Fred Hutch to explore the expanded use of bomedemstat in solid tumors," said Hugh Y. Rienhoff, Jr., M.D., Chief Executive Officer of Imago. "A combination of bomedemstat, which in some solid tumors enhances their immunogenicity, and atezolizumab, an established checkpoint inhibitor, represents a promising clinical opportunity in lung cancer treatment. This new regimen may provide more long-term disease management possibilities for patients who suffer from extensive stage small cell lung cancer."

In ongoing Phase 2 studies in bone marrow cancers, bomedemstat has been generally well-tolerated and has demonstrated significant symptom improvement for patients with essential thrombocythemia and advanced myelofibrosis.

Additional information about the study can be found at www.clinicaltrials.gov using the identifier NCT05191797.

On May 9, 2022 Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products for neuroendocrine and metabolic disorders, reported financial results for the quarter ended March 31, 2022 and provided a corporate update (Press release, Lipocine, MAY 9, 2022, View Source [SID1234613881]).

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Program Highlights

●TLANDO was approved and granted Market Exclusivity by the U.S. Food and Drug Administration ("FDA") for hypogonadism and our licensee expects commercial launch in second quarter of 2022

●Lipocine is currently enrolling subjects in a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhosis, with enrollment in the study expected to be complete by the end of the third quarter of 2022

●Lipocine has requested an End of Phase 2 meeting to discuss the Phase 3 study and confirmatory trial design for LPCN 1144 in non-cirrhotic non-alcoholic steatohepatitis ("NASH")

●An open label extension ("OLE") study in non-cirrhotic NASH has been completed and topline results are expected in May 2022

Board Appointments

The company appointed Jill M. Jene, Ph.D. and Spyros Papapetropoulos, M.D., Ph.D. to its board of directors in April 2022

First Quarter Ended March 31, 2022 Financial Results

Lipocine reported a net loss of $3.5 million or ($0.04 per diluted share), for the quarter ended March 31, 2022, compared with a net loss of $3.4 million, or ($0.04) per diluted share, in the quarter ended March 31, 2021.

Research and development expenses were $1.9 million for the quarter ended March 31, 2022, compared with $1.6 million for the quarter ended March 31, 2021. The increase in research and development expenses for the quarter ended March 31, 2022, was a result of increases in contract research organization expenses related to the ongoing Phase 2 clinical study for LPCN 1148, PK and food effect studies for LPCN 1107 and LPCN 1154, manufacturing scale up expenses for LPCN 1111, and an increase in personnel and other R&D expenses. These increases were offset by a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 LiFT Phase 2 clinical study and a decrease in costs related to TLANDO.

General and administrative expenses were $1.2 million for the quarter ended March 31, 2022, compared with $1.5 million for the quarter ended March 31, 2021. The decrease in general and administrative expenses for the quarter ended March 31, 2022, was primarily due to decreases in legal costs, personnel costs and other general and administrative costs. These decreases were offset by increases in professional fees related to various consulting and proxy solicitation services as well as an increase in corporate insurance expenses.

As of March 31, 2022, the company had $42.0 million of unrestricted cash, cash equivalents and marketable investment securities compared to $46.6 million as of December 31, 2021.