On June 27, 2024 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated biopharmaceutical company, reported it has entered into a placement agency agreement for the purchase and sale of approximately 7,060,918 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.57 per share (or $0.569 per pre-funded warrant in lieu thereof) (Press release, TONIX Pharmaceuticals, JUN 27, 2024, View Source [SID1234644579]). The closing of the public offering is expected to take place on or about June 28, 2024, subject to the satisfaction of customary closing conditions.

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The gross proceeds of the offering will be approximately $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is acting as the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

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 June 27, 2024 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, reported that the underwriters of its previously announced public offering, which closed on June 24, 2024, have exercised an over-allotment option to purchase an additional 1,786,589 shares of the Company’s common stock at the public offering price of $4.00 per share, less underwriting discounts and commissions (Press release, Rezolute, JUN 27, 2024, View Source [SID1234644578]). After giving effect to the option closing, the total number of shares sold by the Company in the offering were 13,036,589 shares, which along with pre-funded warrants to purchase up to an aggregate of 3,750,000 shares of its voting common stock, resulted in aggregate gross proceeds to the Company of approximately $67 million before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.

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In addition, the Company has entered into an agreement for a concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), of 1,500,000 shares of its common stock, at a sale price of $4.00 per share.

Jefferies and Cantor served as the joint book-running managers for the public offering. BTIG, Craig-Hallum, H.C. Wainwright & Co., Jones and Maxim Group LLC are acting as co-managers for the public offering.

A registration statement on Form S-3 (File No. 333-275562) relating to the public offering was filed with the Securities and Exchange Commission (the SEC) on November 22, 2023, and was declared effective by the SEC on November 29, 2023. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC. These documents are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the public offering may also be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at 877-821-7388, or by email at [email protected] or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected]

This press release is being filed pursuant and in accordance with Rule 135(c) under the Securities Act of 1933 and does 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 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 June 27, 2024 Recursion Pharmaceuticals, Inc. ("Recursion") (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, reported that it intends to offer and sell $200.0 million of shares of its Class A common stock in an underwritten public offering (Press release, Recursion Pharmaceuticals, JUN 27, 2024, View Source [SID1234644573]). All of the shares of Class A common stock are being offered by Recursion. In addition, Recursion intends to grant to the underwriters a 30-day option to purchase up to an additional 15% of the shares of Class A common stock offered. The proposed 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.

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Goldman Sachs & Co. LLC and J.P. Morgan are acting as lead book-running managers for the offering. Allen & Company LLC is acting as book-running manager for the offering.

The shares will be offered by Recursion pursuant to a registration statement on Form S-3, which became automatically effective upon filing with the U.S. Securities and Exchange Commission ("SEC") on May 10, 2022. The offering is being made solely by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A copy of the preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Alternatively, a copy of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; or J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement and accompanying prospectus relating to the offering that will be filed with the SEC.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

On June 27, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, reported that the Company received productive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC) (Press release, Oncolytics Biotech, JUN 27, 2024, View Source [SID1234644572]). The FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. The Company’s proposed study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy.

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"Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep’s immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options."

Wayne Pisano, Interim CEO and Chair of the Board of Oncolytics, commented, "We are appreciative of the thoughtful dialog with the FDA and are pleased to have reached an important regulatory milestone that provides a clear path forward for pelareorep’s advancement towards registration in HR+/HER2- mBC. Looking ahead, initiating a registration-enabling trial has become a major corporate objective, and in parallel, we remain on track to report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year. We believe these data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep. We remain committed to improving the standard of care and addressing the high unmet medical needs of these patients."

On June 27, 2024 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported progress updates for its two lead programs, MRT-2359, an MGD being developed for MYC-driven solid tumors, and MRT-6160, a VAV1-directed MGD in development for systemic and neurological autoimmune diseases (Press release, Monte Rosa Therapeutics, JUN 27, 2024, View Source [SID1234644571]).

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"We are pleased with the progress of our two lead programs," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "We continue to successfully recruit and advance our ongoing MRT-2359 Phase 1/2 study. We are encouraged by our initial safety and pharmacodynamic assessment of the 0.5 mg dose using the 21 days on, 7 days off regimen and, as such, we consider the 0.5mg dose with the 21 days on, 7 days off regimen a potential recommended Phase 2 dose. Importantly, this regimen allows for dosing of MRT-2359 twice as frequently per cycle compared to the 5 days on, 9 days off regimen previously explored in our study. Based on the favorable safety assessment for the 0.5 mg dose, we initiated a 0.75 mg, 21 days on, 7 days off dose cohort, which is currently ongoing. In the second half of the year, we expect to make a determination of our definitive recommended Phase 2 dose, share updated clinical efficacy and safety results from the dose escalation arm of the trial, and initiate enrollment of our Phase 2 expansion cohorts."

Dr. Warmuth continued, "Moreover, today we are excited to announce the submission of our Investigational New Drug (IND) application to the U.S Food and Drug Administration (FDA) for MRT-6160, a highly selective and orally bioavailable MGD directed against VAV1. This milestone positions us to soon have our second highly promising program in the clinic, pending FDA clearance. We believe our IND is the first for a rationally designed MGD for a non-oncology indication, representing a significant step forward for Monte Rosa and the protein degradation field. MRT-6160 has been shown to potently and selectively degrade VAV1 in human T and B cells and has demonstrated encouraging results in multiple preclinical studies of autoimmune disease, including models of inflammatory bowel disease, rheumatoid arthritis, and multiple sclerosis. We expect to initiate a Phase 1 single ascending dose / multiple ascending dose (SAD/MAD) study later this summer and anticipate sharing initial clinical data for our MRT-6160 program in Q1 2025."

Monte Rosa continues to evaluate MRT-2359 in a Phase 1/2 clinical trial in MYC-driven solid tumors (NCT05546268). The Company has completed enrollment of the 0.5 mg, 21 days on, 7 days off dose escalation cohort, and tolerability has been favorable with an AE profile similar to what has been observed using the 5 days on, 9 days off schedule at the same dose level. Enrollment is ongoing in the 0.75 mg, 21 days on, 7 days off dose escalation cohort. The Company is evaluating possible Phase 2 expansion cohorts, and anticipates utilizing a two-stage design to enroll patients to evaluate responses in each selected expansion cohort before proceeding with further enrollment.

MRT-6160 is on track for initiation of a Phase 1 SAD/MAD study this summer with Phase 1 clinical data expected in Q1 2025. Monte Rosa expects to subsequently initiate proof-of-concept (POC) studies in autoimmune/inflammatory diseases including ulcerative colitis and rheumatoid arthritis, with additional potential POC studies in dermatology, rheumatology, and neurology indications. Preclinical efficacy data in multiple models of autoimmune/inflammatory diseases and preclinical GLP toxicology data suggest the potential for a highly differentiated profile in T-cell, T/B-cell, and Th17-mediated systemic and neurologic autoimmune diseases.

About MRT-2359

MRT-2359 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) that induces the interaction between the E3 ubiquitin ligase component cereblon and the translation termination factor GSPT1, leading to the targeted degradation of GSPT1 protein. The MYC transcription factors (c‑MYC, L-MYC and N-MYC) are well-established drivers of human cancers that maintain high levels of protein translation, which is critical for uncontrolled cell proliferation and tumor growth. Preclinical studies have shown this addiction to MYC-induced protein translation creates a dependency on GSPT1. By inducing degradation of GSPT1, MRT-2359 is designed to exploit this vulnerability, disrupting the protein synthesis machinery, leading to anti-tumor activity in MYC-driven tumors.

About MRT-6160

MRT-6160 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader of VAV1, which in preclinical studies has shown deep degradation of its target with no detectable effects on other proteins. VAV1, a Rho-family guanine nucleotide exchange factor, is a key signaling protein downstream of both the T- and B-cell receptors. VAV1 expression is restricted to blood and immune cells, including T and B cells. Preclinical studies have shown that targeted degradation of VAV1 protein via an MGD modulates both T- and B-cell receptor-mediated activity. This modulation is evident both in vitro and in vivo, demonstrated by a significant decrease in cytokine secretion, proteins vital for maintaining autoimmune diseases. Moreover, VAV1-directed MGDs have shown promising activity in preclinical models of autoimmune diseases and thus have the potential to provide therapeutic benefits in multiple systemic and neurological autoimmune indications, such as inflammatory bowel disease, rheumatoid arthritis, multiple sclerosis, and dermatological disorders. Preclinical studies have demonstrated that MRT-6160 can inhibit disease progression in several in vivo autoimmunity models.