On July 23, 2024 Mendus AB ("Mendus" publ; IMMU.ST) reported that it has entered into a collaboration with Institut Bergonié, a leading cancer center in Bordeaux, France to study the Mendus’ intratumoral immune primer ilixadencel in soft tissue sarcomas as part of the REGOMUNE trial, a multicenter, prospective open-labeled phase 1/2 trial combining regorafenib and avelumab in solid tumors (Press release, mendus, JUL 23, 2024, View Source [SID1234645014]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Based on promising signs of clinical efficacy in a wide range of solid tumors and following the successful implementation of manufacturing process improvements, Mendus had previously communicated its decision to move the ilixadencel program forward in hard-to-treat solid tumors, with soft tissue sarcomas as a prioritized indication. Mendus announces today a collaboration with Institut Bergonié, Bordeaux, France to study ilixadencel as a novel immunotherapy in combination with the tyrosine kinase inhibitor (TKI) regorafenib and the immune checkpoint inhibitor avelumab as part of the REGOMUNE trial, which is coordinated by Institut Bergonié. Bayer AG supplies regorafenib and Merck KGaA supplies avelumab as study drug for the trial.

"To study ilixadencel in soft tissue sarcomas provides for the opportunity to assess the relevance of intratumoral immune priming with ilixadencel in hard-to-treat tumors that are poorly responding to currently available therapies", says Jeroen Rovers, Chief Medical Officer at Mendus. "Based on our completed clinical trials we are confident that ilixadencel can be safely combined and may act synergistically with tyrosine kinase inhibitors and immune checkpoint inhibitors. This provides for a solid basis to study the combination with regorafenib and avelumab in collaboration with Institut Bergonié as part of the REGOMUNE trial."

The REGOMUNE trial (ClinicalTrials.gov ID: NCT03475953) is a prospective open-labeled phase 1/2 trial combining regorafenib and avelumab in multiple solid tumors, led by Dr Sophie Cousin and Prof Dr Antoine Italiano. Following a phase 1b dose escalation study design, the combination of regorafenib with avelumab is being evaluated in 17 cohorts of advanced or metastatic tumors in independent phase 2 trials. The trial is recruiting patients in 7 specialized cancer hospitals throughout France. As part of the trial, Mendus will supply ilixadencel as study drug to treat up to 43 patients suffering from soft tissue sarcomas (STS).

Institut Bergonié is a comprehensive cancer center which, is the regional reference center for oncology in the Nouvelle-Aquitaine region of France. The center has a long history in cancer research and recently celebrated its centennial anniversary. Institut Bergonié is part of UNICANCER, a national hospital network of 20 French Comprehensive Cancer Centers (FCCC) which are entirely devoted to fighting cancer with the same unique model based on patient care, research and oncology education.

"Institut Bergonié is committed to provide access to all areas of cancer research to patients", says Prof Dr Antoine Italiano, principal investigator of the REGOMUNE trial and head of the Department of Medicine at Institut Bergonié. "Through our own research and in collaboration with external partners, we develop innovative treatments where they are most needed and the REGOMUNE trial is an excellent example of how we bring together promising new combination therapies to address hard-to-treat tumors. Based on its promising signs of efficacy and excellent safety profile, we look forward to add ilixadencel to the combination of regorafenib and avelumab for treatment of soft tissue sarcomas in the REGOMUNE trial."

Mendus and Institut Bergonié expect to complete the preparations for the ilixadencel treatment arm within the REGOMUNE trial in the second half of 2024 and first patient data to be available first half of 2026.

"Our continued research efforts and manufacturing process improvements allow us to bring ilixadencel back into clinical development and we feel privileged to work with Institut Bergonié as one of the leading cancer centers in Europe based on clinical and medical-scientific expertise", says Mendus CSO Alex Karlsson Parra. "A next wave of innovation in immuno-oncology is expected to come from novel combination approaches for tumors that are poorly responding to currently available therapies and this is where we have focused our preclinical and clinical research with ilixadencel. The REGOMUNE trial provides for an excellent opportunity to evaluate intratumoral immune priming with ilixadencel as a treatment which can have a meaningful impact in the lives of people suffering from hard-to-treat tumors."

On July 22, 2024 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the majority of Tranche B warrants issued under its September 2023 private placement have been exercised for Series E preferred stock, convertible into the company’s common stock, by the participants of the previous financing, led by Rosalind Advisors, in exchange for a reduced, as-converted common stock price of $2.52 and the purchase of new warrants (Press release, Cellectar Biosciences, JUL 22, 2024, View Source [SID1234645000]). The exercised Tranche B warrants and newly purchased warrants will generate gross proceeds of approximately $19.4 million. The new warrants purchased by investors have the potential to generate up to an additional $73.3 million in gross proceeds, if exercised.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The new warrants purchased by investors include Tranche A, B and C. The Tranche A warrants provide gross proceeds up to approximately $17.0 million based on the exercise price of $2.52, which was the closing market price of the Company’s common stock on July 19, 2024, and include a 10-trading-day trigger for exercise following Cellectar’s public announcement of the Food and Drug Administration (FDA) having assigned a Prescription Drug User Fee Act goal date for review of iopofosine I 131. The Tranche B Warrants provide gross proceeds up to approximately $32.9 million based on an exercise price of $4.00 per share, with a 10-trading-day trigger for investors to exercise upon FDA approval of iopofosine I 131. The Tranche C warrants provide gross proceeds up to approximately $23.5 million based on an exercise price of $5.50 per share, with a 10-trading-day trigger for investors to exercise following Cellectar reporting domestic quarterly revenue from iopofosine I 131 exceeding $10.0 million.

The new warrants have not been registered under the Securities Act of 1933, as amended, or applicable under state securities laws. Accordingly, the securities 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. As part of the transaction, the Company has agreed to file a resale registration statement on Form S-3 with the Securities and Exchange Commission within 30 days of the exercise date of the Tranche B warrants to register the resale of the shares of common stock underlying the new warrants.

The company expects to file an NDA for iopofosine I 131 for the treatment of Waldenstrom’s macroglobulinemia in the fourth quarter of 2024 and will be seeking a priority review. Funds generated from the execution of these warrants are expected to advance the company to commercialization.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On July 22, 2024 Epigenomics AG (FSE: ECX; ISIN: DE000A37FT41) reported that it has closed its first half of the 2024 fiscal year (January 1 to June 30, 2024) with an expected loss (individual financial statements according to the German Commercial Code) of EUR 0.8 million (comparable period 1H 2023 ("H1"): loss EUR 5.7 million) and with freely available liquid funds (consisting of cash and bank balances) of EUR 1.2 million as of June 30, 2024 (previous year December 31, 2023 ("previous year"): EUR 2.1 million) (Press release, Epigenomics, JUL 22, 2024, View Source [SID1234645001]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The preliminary result includes other operating income of EUR 78 thousand (previous year: EUR 438 thousand), as well as personnel expenses of EUR 233 thousand (previous year: EUR 3,502 thousand), other operating expenses of EUR 465 thousand (previous year: EUR 2,575 thousand) and a financial result of EUR -164 thousand (previous year: EUR 306 thousand), mainly consisting of depreciation on financial assets of EUR 178 thousand (previous year: EUR 0 thousand).

Other operating expenses mainly include legal and consulting costs (EUR 152 thousand), costs of stock exchange listing and capital market communication (EUR 97 thousand), IT costs (EUR 62 thousand) and accounting and auditing costs (EUR 56 thousand).

The preliminary balance sheet as of June 30, 2024 according to the German Commercial Code (HGB) shows negative equity of EUR 8,344 thousand (previous year: negative equity EUR 8,016 thousand).

In the forecast report of the last annual financial statements (financial year 2023), the Management Board forecast an annual result in the range of EUR -1.2 million to EUR -0.8 million for the financial year 2024. The Management Board is currently sticking to the existing forecast for the financial year 2024.

The above-mentioned preliminary result is based on the preliminary assessment of the first half of 2024 carried out by the Management Board on July 22, 2024.

On July 22, 2024 Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA), a clinical stage biopharmaceutical company that has been developing a treatment for non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic liver diseases, reported it has entered into a definitive merger agreement (the "Merger Agreement") with Pharma Two B Ltd., a late-clinical stage private Israeli company that is developing P2B001, an innovative combination product candidate in development for the treatment of Parkinson’s Disease ("PD") (Press release, Hepion Pharmaceuticals, JUL 22, 2024, View Source [SID1234645002]). Under the Merger Agreement, Hepion will merge into and become an indirectly wholly-owned subsidiary of Pharma Two B (the "Merger"). The combined company will continue to operate under the "Pharma Two B" name and Pharma Two B has agreed to file a registration statement on Form F-4 (the "Form F-4") with the U.S. Securities and Exchange Commission (the "SEC") to register the ordinary shares proposed to be issued (or reserved for issuance) to Hepion’s equity-holders in the acquisition, and will also apply to list its ordinary shares on Nasdaq under the ticker symbol "PHTB".

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"P2B001 offers a novel, easy-to-use therapeutic approach, that is designed to address the unmet need for an effective, safe, once-daily, no titration required treatment with a lower incidence of excessive daytime sleepiness-a common side effect of currently available dopamine agonist treatments in Parkinson’s disease patients" said Dan Teleman, Chief Executive Officer of Pharma Two B. "As we advance P2B001’s development following the successful completion of our Phase 3 clinical trial, we believe it is the right time to enter the public equity markets. Our company is in a stage that we believe meets the public market and investors’ expectations. We are excited about Pharma Two B’s next growth phase, moving P2B001 towards an NDA submission targeted for the first half of 2026 and making this potential treatment available to patients," he continued.

"Consistent with our December 7, 2023 announcement, the Hepion Board of Directors conducted a review of multiple strategic alternatives to identify paths to provide value to our stockholders. We believe the transaction we are announcing today with Pharma Two B Ltd. presents an excellent opportunity for our shareholders to become a part of a company poised to file an NDA in a therapeutic area with a major unmet medical need," said John Brancaccio, Executive Chairman.

Hepion has also announced a private placement of $2.9 million non-convertible senior notes to qualified institutional investors. The notes are unsecured, interest-free, and were issued with an aggregate $400.0 thousand original issue discount, and mature at the earlier of: (i) December 31, 2024; (ii) the closing of Merger; or (iii) the termination of Merger pursuant to terms of Merger Agreement. Hepion also loaned $600.0 thousand of the proceeds to Pharma Two B through a non-convertible unsecured note that bears nominal interest and matures on the same terms as the $2.9 million notes, but which will be forgiven and cancelled upon consummation of the Merger. In connection with the purchase of the notes, the investors received 1,159,245 shares of Hepion common stock, or approximately 19.99% of Hepion’s outstanding common stock immediately prior to the issuance.

In support of the Merger, Pharma Two B has entered into a securities purchase agreement for an $11.5 million private placement of ordinary shares (or pre-funded warrants in lieu thereof) and accompanying Series A warrants and Series B warrants with a syndicate of new and existing institutional life science investors. The private placement is expected to close immediately after the closing of the Merger. The Series A warrants will have a 5-year term, and an exercise price of $6.00 per ordinary share. The Series B warrants will have a 2.5-year term, and an exercise price of $6.00 per ordinary share. The warrants will have customary anti-dilution adjustments as well as anti-dilution price protection and share adjustment features, subject to a floor price of 20% of the initial exercise price per share, as well as a cash true up feature, in each case subject to certain limitations. Pharma Two B has agreed to register for resale the shares (including shares underlying the warrants) to be issued in the concurrent private financing.

The securities offered and sold in the private placements by each of Hepion and Pharma Two B will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

Merger Overview

Under the terms of the Merger Agreement, the Merger is valued at an estimated pro-forma implied equity value of approximately $58.5 million. At close, Pharma Two B expects up to $11.5 million of gross cash proceeds, and intends to use net proceeds to fund continuing growth and expansion of its lead product candidate P2B001 and repay up to $2.9 million of Hepion’s senior unsecured notes to the extent outstanding at closing of the Merger.

Following the Merger, the combined company will continue to be led by Pharma Two B’s management, a highly experienced team in PD, supported by top-tier scientific and clinical key opinion leaders and backed by a dedicated group of investors.

Additional information about the Merger and the private placements will be provided in a Current Report on Form 8-K that will be filed by Hepion with the SEC and will be available at www.sec.gov. The Merger is expected to close in the fourth quarter of 2024 and is subject to approval by Hepion’s stockholders, regulatory approval, and other customary closing conditions.

Advisors

A.G.P./Alliance Global Partners is serving as financial advisor to Hepion and Sheppard, Mullin, Richter & Hampton LLP is acting as U.S. legal advisor to Hepion and Lipa Meir & Co.is acting as Israeli legal advisor to Hepion. Sullivan & Worcester LLP is serving as legal advisor to A.G.P.

Laidlaw & Company (UK) Ltd. is acting as financial advisor to Pharma Two B. and Meitar Law Offices and Goodwin Procter LLP are acting as legal advisors to Pharma Two B.

On July 22, 2024, Nuvalent, Inc. reported the initiation of HEROEX-1, its Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer, with the dosing of the first patient in the trial (Press release, Nuvalent, JUL 22, 2024, View Source [SID1234645003]). The HEROEX-1 trial will evaluate the overall safety and tolerability of NVL-330. Additional objectives include determination of the recommended Phase 2 dose, characterization of the pharmacokinetic profile, and preliminary evaluation of anti-tumor activity.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!