On June 14, 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 the pricing of its previously announced underwritten public offering of an aggregate of 11,250,000 shares of its common stock at an offering price of $4.00 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 3,750,000 shares of common stock at an offering price of $3.999 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant (Press release, Rezolute, JUN 14, 2024, View Source [SID1234644337]). Gross proceeds from the underwritten public offering before deducting underwriting discounts and commissions and other offering expenses are expected to be approximately $60 million.

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All shares of common stock and pre-funded warrants to be sold in the offering will be offered by Rezolute. The closing of the offering is expected to occur on or about June 17, 2024, subject to the satisfaction of customary closing conditions.

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

A shelf registration statement on Form S-3 (File No. 333-275562) relating to the securities to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") and was declared effective on November 29, 2023. The public offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus has been filed with the SEC and may be obtained on the SEC’s website at www.sec.gov. A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the underwritten public offering will be filed with the SEC and, when available, may be obtained on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the public offering, when available, may 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 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 14, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported additional efficacy findings from the Company’s ongoing Phase 1B/2 (MB-106) clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with acute myeloid leukemia (AML) (Press release, Moleculin, JUN 14, 2024, View Source [SID1234644335]). The preliminary data was presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Hybrid Congress. The Company also hosted a data presentation to leading AML experts as part of a KOL meeting held in conjunction with EHA (Free EHA Whitepaper) 2024 Congress.

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To date, a total of 22 subjects have been enrolled (the Intent-to-Treat population, ITT), 20 (Lines 1st-7th) of whom have completed efficacy evaluations with 9 subjects (45%) achieving a composite complete remission (CRc or CR/CRi), consisting of 8 (40%) subjects with complete remission (CR) and one subject with complete remission with an incomplete recovery of peripheral blood counts (CRi), following treatment with AnnAraC. Efficacy outcomes for 2 additional subjects (enrolled and treated) are pending.

Of the 10 ITT subjects for whom AnnAraC was administered in the 2nd line setting, 5 achieved a CR (50%) and 6 achieved a CRc (60%). Of the 13 subjects in the ITT evaluable population that were 1st or 2nd line treatment, 7 achieved a CR (54%) and 8 achieved a CRc (62%). The mDOR for the 9 subjects who achieved a CRc is approximately 6 months and climbing. Additionally, the median overall survival in the 2nd line subjects (n=10) is approximately 6 months and increasing.

Additionally, 89% of the subjects included in the CRc group (n=9) had cytogenetics and/or mutations generally considered to contribute to a poor prognosis. These include FLT3, IDH2, ASXL1, KMT2A and others. While not yet statistically relevant, the Company believes such cytogenetic and mutation data are informative to clinicians.

"We continue to be highly encouraged by the positive growing body of preliminary clinical data demonstrated by Annamycin in the treatment of patients with AML," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "While still preliminary, we believe the efficacy to date including the climbing durability of response demonstrated by AnnAraC in 2nd line patients continues to significantly exceed the performance reported by any drug currently approved for use in 2nd line AML. We are incredibly pleased with the progress of the trial and the data and continue to advance our preparations for an End of Phase 2 meeting with FDA."

"There remains a significant unmet need for safe and effective therapies for R/R AML. These data are exciting, and I believe further underscore the potential of Annamycin to provide patients and physicians with a promising treatment option in AML," concluded Mr. Klemp.

Currently, the median age of subjects in MB-106 is 69 years. Not including the two most recent subjects, a total of 17 subjects had relapsed/refractory AML and 3 subjects were first line treatment. Two subjects discontinued early due to allergic reactions. All subjects who completed treatment had undergone post-therapy bone marrow assessment (Day 15 or later). No clinically significant signs of cardiotoxicity were noted during or after treatment in any of the subjects enrolled. The combination was well tolerated with myelosuppression and infections being the main adverse events (AEs). All data from MB-106 is preliminary and subject to change.

Data presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Hybrid Congress:

As previously announced, the poster titled "LIPOSOMAL ANNAMYCIN (L-ANN) IN COMBINATION WITH CYTARABINE FOR TREATMENT OF PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) REFRACTORY TO OR RELAPSED (R/R) AFTER INDUCTION THERAPY (MB-106 STUDY)," was presented as part of the "Acute myeloid leukemia – Clinical" session by Wolfram C. M. Dempke, MD, PhD, MBA, European Chief Medical Officer of Moleculin. The poster presentation mentioned above will be posted on the Company’s website and filed on Form 8-K with the Securities and Exchange Commission.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA). For more information about the ongoing MB-106 Phase 1B/2 trial, visit clinicaltrialsregister.eu and reference EudraCT 2020-005493-10 or clinicaltrials.gov and reference NCT05319587.

On June 14, 2024 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported additional data from Part 1 of its ongoing SUMMIT clinical trial evaluating the selective KIT D816V inhibitor, bezuclastinib, in patients with nonadvanced systemic mastocytosis (NonAdvSM) (Press release, Cogent Biosciences, JUN 14, 2024, View Source [SID1234644334]). The data are being presented today in a poster presentation at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Congress taking place in Madrid, Spain.

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"We are excited to share additional analyses from SUMMIT Part 1 which highlight substantial symptomatic reductions as well as improvement in objective measures of disease," said Andrew Robbins, Chief Executive Officer at Cogent Biosciences. "We remain on track to complete enrollment in the registration-directed SUMMIT Part 2 study in the second quarter of 2025 and report topline results by year-end 2025."

"Nonadvanced systemic mastocytosis is a debilitating hematologic disorder and physicians and patients remain in search of more effective treatment options to fight this disease," said Lindsay Rein, MD, Associate Professor of Medicine in the Division of Hematologic Malignancies and Cellular Therapy at Duke University. "I am impressed with the rapid patient response and reductions seen across all domains at 12 weeks as well as the safety and tolerability. I believe bezuclastinib shows promise in treating nonadvanced systemic mastocytosis where significant unmet needs remain."

SUMMIT Trial Update
SUMMIT is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial of bezuclastinib in patients with NonAdvSM. Part 1 of the trial was designed to determine the recommended dose of bezuclastinib. In addition, the study was designed to explore the effects of bezuclastinib on the signs and symptoms of NonAdvSM, including assessment of disease-specific symptom severity using a novel patient-reported outcome measure, the Mastocytosis Symptom Severity Daily Diary (MS2D2). As of the cutoff date, December 18, 2023, patients in Part 1 treated at the recommended dose of 100 mg bezuclastinib demonstrated >90% reductions across all markers of mast cell burden. Additional data also show meaningful reduction in symptom severity and objective measures of disease, including:

Substantial reduction in mast cell reactions (>50%) and patients’ most severe symptoms as measured by MS2D2
Clinically meaningful reduction in all individual MS2D2 TSS symptoms and across domains, as well as additional symptoms including dizziness, diarrhea severity, and brain fog
Clinically meaningful improvement in skin symptoms as well as objective reduction in skin lesions
Safety Data from SUMMIT Part 1 
Consistent with results previously reported, as of the December 18, 2023 cutoff date, the recommended dose of 100 mg demonstrates a favorable safety and tolerability profile. There were no bleeding or cognitive impairment adverse events reported and no serious adverse events reported.

EHA Poster Details
Title: Symptom-Focused Results from SUMMIT Part 1: An Ongoing, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial of Bezuclastinib in Adult Patients with NonAdvanced Systemic Mastocytosis
Presenting Author: Lindsay Rein, MD
Abstract #: P1055
Poster Session Date and Time: June 14, 2024 at 18:00 – 19:00 CEST

The poster will be available in the Posters and Publications section of Cogent’s website.

Bezuclastinib Clinical Development
Cogent remains on-track to complete enrollment in SUMMIT Part 2 in the second quarter of 2025 and report top-line results by the end of 2025. The Company also remains on track to complete enrollment in the APEX study in patients with advanced systemic mastocytosis (AdvSM) by the end of 2024 and report top-line results mid-2025. Enrollment continues in the Phase 3 registration-enabling PEAK study, which will include approximately 388 second-line, post imatinib patients with Gastrointestinal Stromal Tumors (GIST). Due to rapid enrollment, the Company expects PEAK enrollment to be completed in the third quarter of 2024 with top-line results expected by the end of 2025.

On June 14, 2024 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 it has entered into securities purchase agreements with health-care focused institutional investors for the purchase and sale of 366,000 shares of common stock (or common stock equivalents in lieu thereof) in a registered direct offering and warrants to purchase up to 366,000 shares of common stock in a concurrent private placement (together with the registered direct offering, the "Offering") at a combined purchase price of $3.75 per share (Press release, CNS Pharmaceuticals, JUN 14, 2024, View Source [SID1234644333]). The warrants issued pursuant to the concurrent private placement will have an exercise price of $3.62 per share, will be exercisable immediately following the date of issuance and will expire 5 years from the initial exercise date.

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The closing of the Offering is expected to occur on or about June 17, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $1.37 million before deducting financial advisory fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

The common stock and common stock equivalents in lieu thereof will be issued in a registered direct offering pursuant to an effective shelf registration statement on Form S-3 (File No. 333-279285) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), under the Securities Act of 1933, as amended (the "Securities Act"), and declared effective by the SEC on May 17, 2024. The warrants will be issued in a concurrent private placement. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and once filed, will be available on the SEC’s website located at View Source

The private placement of the ordinary warrants and the underlying shares will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the concurrent private placement 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 Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 June 14, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML) in a poster presentation at 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, on June 14, 2024 in Madrid, Spain (Press release, Bio-Path Holdings, JUN 14, 2024, View Source [SID1234644332]).

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Jorge Cortes, M.D., Director of the Georgia Cancer Center, presented data showing prexigebersen continues to be well-tolerated and has now demonstrated compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy. "It was a pleasure to present these compelling data to an audience of European oncologists who treat AML patients and understand the continued great need for new therapeutic options," said Peter Nielsen, Chief Executive Officer of Bio-Path.

"Given that our study is being conducted in the U.S., this encore presentation is an important step towards educating global oncology leaders on the benefits of prexigebersen and its potential to be another tool in their fight against AML."

Data Highlights

In Cohort 1, 31 newly diagnosed patients were enrolled; 20 evaluable patients (9 male: 45%) with a median age of 75 years (range, 69-84), treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk (n=12, 2017 ELN guidelines) or secondary AML (sAML; n=7) evolved from myelodysplastic syndromes (n=4), chronic myelomonocytic leukemia (n=1) or treatment-related AML (n=2). Fifteen patients (75% of evaluable; 54% of enrolled) achieved complete remission (CR), CRh (CR with partial recovery of peripheral blood counts), or CRi (CR with incomplete hematologic recovery); two patients achieved partial remission (PR) and two patients achieved stable disease (SD).

In Cohort 2, 38 relapsed/refractory patients were enrolled; 23 evaluable patients (13 male: 57%) with a median age of 63 years (range, 24-89), treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk (n=13) or sAML (n=5). Twelve patients (55% of evaluable; 32% of enrolled) achieved CR/CRi/CRh; one patient achieved PR, eight patients achieved SD and one patient had treatment failure.

Among the evaluable patients of both cohorts, adverse events were consistent with those expected with decitabine and venetoclax and/or AML, including fatigue (72%), anemia (60%) and neutropenia (49%), while the most frequent severe adverse events were febrile neutropenia (26%) and sepsis (5%). Given these promising interim results, Bio-Path expects to continue enrollment of up to 98 and 54 evaluable patients for Cohorts 1 and 2, respectively.