INFINITI
7 months ago
Moleculin Announces New Positive Independent Report of No Cardiotoxicity in Annamycin
Source: PR Newswire (US)
– Annamycin continues to demonstrate no evidence of cardiotoxicity to date, now in a total of 62 subjects across three of the Company's Annamycin clinical trials
– Next generation anthracycline, Annamycin, has demonstrated both safety and promising early activity across multiple clinical studies with potential to be an effective treatment across multiple oncology indications
HOUSTON, Sept. 18, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced it has received a new independent assessment for the absence of cardiotoxicity in subjects treated with Annamycin. Data from the following subjects were made available to an expert in chemotherapy who is affiliated with a leading cancer research institute in assessing cardiotoxicity. After review of this data, the independent expert concluded that there was no evidence of cardiotoxicity:
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)
The first cohort of 3 subjects (190 mg/m2) of its Phase 1B/2 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 AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB106). clinicaltrialsregister.eu: EudraCT 2020-005493-10 or clinicaltrials.gov: NCT05319587;
Cohort 4a (360 mg/m2) in the Phase 1B portion of the Company's ongoing U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB-107), comprised of 3 subjects. clinicaltrials.gov: NCT04887298; and
14 subjects in the Phase 2 expansion Recommended Phase 2 Dose (RP2D) (330 mg/m2) of the ongoing U.S. Phase 1B/2 MB-107 clinical trial.
This brings the total reviewed by an independent expert to 62 subjects covering 4 separate clinical trials in the U.S. and in Europe.
The data made available included left ventricular ejection fraction (LVEF) as determined by echocardiograms, ECHO strain imaging, and Troponin levels. "ECHO strain imaging" is a method in echocardiography (medical ultrasound) for measuring regional or global deformation (contraction or beating) of the myocardium (heart muscle). By strain rate imaging, the simultaneous function of different regions can be displayed and measured. Cardiac health biomarkers such as blood Troponin levels are considered an indicator of potential long-term heart damage.
"We continue to be encouraged by the potential of Annamycin, especially with the reports from this expert covering 62 subjects. This additional independent report of additional datasets provides further validation in the absence of cardiotoxicity," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Annamycin continues to establish itself as a non-cardiotoxic anthracycline, even in subjects who have received far more than the lifetime maximum cumulative anthracycline exposure established by the FDA. In fact, 53 of the 62 subjects evaluated have been taken over the lifetime maximum of 450 mg/m2 and one of them as high as 3420 mg/m2. Our growing body of positive data for Annamycin continues to bolster our confidence in our belief that Annamycin is truly a 'next generation' anthracycline, especially in light of the growing efficacy data that we have previously reported in the treatment of STS lung mets and AML. We remain focused on advancing our Annamycin development programs and ultimately, addressing the medical unmet needs of people with difficult to treat cancers and viruses."
Annamycin is the Company's next-generation anthracycline that has been designed to be non-cardiotoxic (unlike currently prescribed anthracyclines) and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (a commonly prescribed anthracycline), as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Annamycin is currently in development for the treatment of STS lung metastases (STS lung mets) as well as both first line therapy and therapy for relapsed or refractory acute myeloid leukemia (AML), and the Company believes the drug may have the potential to treat additional indications.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses. The Company's lead program, Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of COVID-19 and other viruses, as well as cancer indications including brain tumors, pancreatic and other cancers.
For more information about the Company, please visit www.moleculin.com and connect on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,' 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
TheFinalCD
12 months ago
Recent Highlights
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Announced the publication of data evaluating Annamycin’s performance as an anthracycline designed to avoid the cardiotoxicity typically associated with currently prescribed anthracyclines, in a manuscript titled, "Anthracycline-induced cardiotoxicity – are we about to clear this hurdle?,” published in the peer-reviewed European Journal of Cancer.
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Received approval in Italy to conduct and dosed first subjects for Phase 1/2 trial evaluating Annamycin in combination with cytarabine (Ara-C) for the treatment of acute myeloid leukemia (AML).
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Announced final topline successful safety data – setting a recommended Phase 2 dose - and reported 80% overall response rate in final cohort from the European Phase 1 trial evaluating Annamycin as a single agent treatment of Refractory AML.
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Granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) of WP1122 for the treatment of Glioblastoma Multiforme (GBM).
Summary of Financial Results for the Full Year 2022
Research and development (R&D) expense was $19.0 million and $14.4 million for the years ended December 31, 2022 and 2021, respectively. The increase in R&D of $4.6 million is mainly related to increased clinical trial activity, and costs related to manufacturing of additional drug product.
General and administrative (G&A) expense was $11.5 million and $8.4 million for the years ended December 31, 2022 and 2021, respectively. The increase in G&A of $3.1 million was mainly attributable to an increase in regulatory and legal services, and consulting & advisory fees.
The net loss for the year ended December 31, 2022 was $29.0 million, which included non-cash gains of $1.3 million on warrants in 2022 as compared to $6.7 million in the prior year and approximately $2.3 million of stock-based compensation expense in 2022 as compared to $2.4 million in 2021.
As of December 31, 2022, we had cash and cash equivalents of $43.1 million and prepaid expenses and other current assets of $2.5 million. The Company believes that this cash is sufficient to meet its projected operating requirements into the third quarter of 2024.
tigertiger88
3 years ago
Moleculin Announces Proposed Underwritten Public Offering
Download as PDFFebruary 02, 2021
HOUSTON, Feb. 2, 2021 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that it intends to offer and sell shares of common stock (or pre-funded warrants in lieu thereof) in an underwritten public offering. All shares of common stock (or pre-funded warrants in lieu thereof) in the offering will be sold by Moleculin. As part of this offering, Moleculin intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The proposed offering is subject to market and other conditions. 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.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)
Oppenheimer & Co. Inc. is acting as the sole book-running manager for the proposed offering.
The Company intends to use the net proceeds of the offering to fund its planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes.
The securities described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (No. 333-235686) originally filed December 23, 2019 with the Securities and Exchange Commission (SEC) and declared effective by the SEC on April 9, 2020. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may be obtained, when available, from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at EquityProspectus@opco.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.
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 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.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses. The Company's clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including other Immune/Transcription Modulators, as well as WP1122 and related compounds capable of Metabolism/Glycosylation Inhibition.
For more information about the Company, please visit http://www.moleculin.com.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements about the anticipated completion, timing and size of the public offering and the anticipated use of net proceeds therefrom,. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements as a result of various important factors, including: market conditions that may affect the timing, terms and conditions of the offering, our ability to satisfy the conditions to closing of the offering and other matters affecting our ability to consummate the offering on terms acceptable to us. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Contacts
James Salierno / Carol Ruth
The Ruth Group
973-255-8361 / 917-859-0214
jsalierno@theruthgroup.com
cruth@theruthgroup.com
Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/moleculin-announces-proposed-underwritten-public-offering-301220657.html
SOURCE Moleculin Biotech, Inc.
Released February 2, 2021
tigertiger88
3 years ago
Supplement No. 1 dated February 2, 2021 to Prospectus Supplement dated November 12, 2020 (to Prospectus dated April 9, 2020)
Filed Pursuant to Rule 424(b)(5) Registration No. 333-235686
This Supplement No. 1 to Prospectus Supplement supplements and amends the Prospectus Supplement dated November 12, 2020 (the “Prospectus Supplement”) filed by us. This Supplement No. 1 to Prospectus Supplement should be read in conjunction with the Prospectus Supplement and the Prospectus dated April 9, 2020.
We previously entered into a purchase agreement, dated as of November 12, 2020 (“Purchase Agreement”), with Lincoln Park Capital Fund, LLC, or Lincoln Park, related to the issuance and sale of up to $22,000,000 of shares of our common stock that we may sell to Lincoln Park from time to time pursuant to the Purchase Agreement, as well as 126,699 shares of our common stock (taking into account the one-for-six reverse stock split completed January 29, 2021) issued to Lincoln Park as commitment shares under the Purchase Agreement, and up to an additional 50,680 shares of our common stock (taking into account the one-for-six reverse stock split completed January 29, 2021) that may be issued to Lincoln Park as commitment shares pro-rata when and if Lincoln Park purchased the $22,000,000 aggregate commitment.
We filed the Prospectus Supplement to a base prospectus dated April 9, 2020 (the “Base Prospectus”), to register the issuance and sale of up to $22,000,000 of shares of our common stock that we may sell to Lincoln Park pursuant to the Purchase Agreement, the 126,699 shares of our common stock (taking into account the one-for-six reverse stock split completed January 29, 2021) issued to Lincoln Park as commitment shares under the Purchase Agreement, and up to an additional 50,680 shares of our common stock (taking into account the one-for-six reverse stock split completed January 29, 2021) that may be issued to Lincoln Park as commitment shares pro-rata when and if Lincoln Park purchased (at our discretion) the $22,000,000 aggregate commitment.
We terminated the Purchase Agreement on February 2, 2021. We sold a total of 638,203 shares of common stock (taking into account the one-for-six reverse stock split completed January 29, 2021) pursuant to the Prospectus Supplement for total proceeds of $2,742,499.67 and issued a total of 133,017 commitment shares (taking into account the one-for-six reverse stock split completed January 29, 2021) pursuant to the Prospectus Supplement. The purpose of this Supplement No. 1 to Prospectus Supplement is to terminate the offering under the Prospectus Supplement and the Base Prospectus, effective on the termination date.
The date of this prospectus supplement no. 1 is February 2, 2021
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