Corporate Presentation

On May 14, 2024 ADC Therapeutics presented its corporate presentation (Presentation, ADC Therapeutics, MAY 14, 2024, View Source [SID1234643205]).

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Actinium Announces Oral Presentation Detailing Improved Survival Outcomes in TP53 Positive Patients at the EHA 2024 Annual Congress and Presentation of Long-Term Efficacy Results in Older Patients Receiving an Iomab-B Led Bone Marrow Transplant in the Phase 3 SIERRA Trial

On May 14, 2024 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, reported that results from the Phase 3 SIERRA trial of Iomab-B have been accepted for an oral presentation and poster presentation at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress being held June 13 – 16, 2024, in Madrid, Spain (Press release, Actinium Pharmaceuticals, MAY 14, 2024, View Source [SID1234643204]). The Phase 3 SIERRA trial enrolled 153 patients ages 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML) and compared outcomes of patients receiving an Iomab-B led bone marrow transplant (BMT) to those of patients receiving physician’s choice of care in the control arm. Across all patients in SIERRA study, only patients receiving an Iomab-B led BMT achieved the trial’s primary endpoint of durable complete remission with these patients having 92% 1-year survival and 69% 2-year survival with statistically significant higher event free survival. The SIERRA trial enrolled high-risk patients including those with one or more of the following: a TP53 mutation, advanced age up to 77 years old, complex cytogenetics and prior therapy including venetoclax and other targeted agents.

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In total, 24% (37/153) of the patients enrolled on SIERRA had a TP53 mutation, which is usually associated with limited treatment options and poor outcomes. Median Overall Survival of 5.49 months observed in patients with a TP53 mutation receiving an Iomab-B led allogeneic bone marrow transplant compared to 1.66 months in patients that did not receive Iomab-B (hazard ratio=0.23, p=0.0002).

Iomab-B EHA (Free EHA Whitepaper) presentations titles are as follows:

Oral Presentation

131I-APAMISTAMAB-LED ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT RESULTS IN IMPROVED SURVIVAL OUTCOMES IN R/R AML PATIENTS WITH HIGH-RISK TP53 MUTATIONS IN THE RANDOMIZED PHASE III SIERRA TRIAL

Poster Presentation

LONG TERM EFFICACY RESULTS OF THE SIERRA TRIAL: A PHASE 3 STUDY OF 131I-APAMISTAMAB-LED ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION VERSUS CONVENTIONAL CARE IN OLDER PATIENTS WITH ACTIVE, R/R AML

MaaT Pharma Launches a Global Offering of approximately 18 Million Euros

On May 14, 2024 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported the launch of an offering of approximately 18 million euros, comprising a reserved offering of new ordinary shares to categories of investors and a public offering of new ordinary shares to retail investors (via the PrimaryBid platform) (the "Primary Offering"), and a sale of existing shares for 1 million euros, at a price of €8 per share (the "Offering Price") (Press release, MaaT Pharma, MAY 14, 2024, View Source [SID1234643194]).

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MaaT Pharma will use the net proceeds of the Primary Offering to fund the continued development of its Microbiome Ecosystem TherapiesTM, including:

completion of the Phase 3 trial for MaaT013 in Europe, including top-line results/primary endpoint expected in mid-Q4 2024;
refining the pipeline development, encompassing the initiation of Phase 3 trial activities for MaaT013 in the US and the broadening of the Phase 2b trial with MaaT033 across Europe; and
working capital and other general corporate purposes, including repayment of current debts.
In the context of the Global Offering, the Company benefits from the long-term support of its historical shareholders Bpifrance Investissement, Biocodex and Seventure Partners who have committed themselves to subscribe for a total amount of €14.3m in the Global Offering, subject to the Reserved Offering representing at least €17 million.

Excluding the proceeds of the Reserved Offering, on the basis of planned expenditure, total cash and cash equivalents as of March 31, 2024, of €18.2 million (unaudited), the Company estimates that it will be able to fund its operations until the end of September 2024. On the same basis, including the proceeds of the Reserved Offering representing more than €17 million, the Company estimates that it will be able to finance its operations into early Q1 2025. The Company is also engaged to seek further financing dilutive and/or non-dilutive financing solutions to finance operations beyond early Q1 2025 and remains confident in extending its cash runway to meet its financial obligations over the next 12 months. The Company reports in parallel revenues of EUR 0.8 million for the first quarter of 2024 compared with EUR 0.7 million for the same period of 2023, in relation to its Early Access Program for MaaT013 in Europe.

Concurrently with the Primary Offering, certain funds managed by Seventure Partners (together, the "Selling Shareholder") will sell a maximum of 125,000 shares, representing a maximum amount of 1 million euros (the "Secondary Offering" and together with the Primary Offering, the "Global Offering"). These funds are currently in a divestment period and are progressively selling the shares they hold in the Company, but Seventure Partners will continue to support the development and growth of the Company and has committed to participate to the Reserved Offering through other funds.

Hervé Affagard, CEO and co-founder of MaaT Pharma, commented: "We are pleased to announce a capital increase at a price of €8 per share with €14,4 million already committed by our longstanding investors and management. While anchored around our historical investors, this offering is strategically aimed at continuing expanding our shareholder base through retail investors, further increasing our market float. Thus, we have partnered with the PrimaryBid platform to offer them the opportunity to join us under the same conditions as institutional investors.

This transaction will enable us to finalize and present the primary endpoint of the Phase 3 trial of our lead product, MaaT013, in acute graft-versus-host disease, and to support the increase of maturity of our pipeline, including the expansion in the US.

Encouraged by the positive clinical data from our recent early access program, we are highly motivated to push forward in our development efforts. We are dedicated to a structured approach that aims to bring innovative therapeutic solutions to patients who are battling diseases with limited treatment options and challenging prognoses."

Terms and Conditions of the Global Offering

The Global Offering will be carried out in three concomitant components under the same pricing conditions:

a reserved offering (the "Reserved Offering") of new ordinary shares without pre-emptive subscription rights, to specific categories of investors, namely: (i) natural person(s) or legal entity(ies), including companies, trusts, investment funds or other investment vehicles, in any form, established under French or foreign law, that regularly invest in the pharmaceutical, biotechnological or medical technologies sectors, as the case may be, when an industrial, commercial, licensing, research or partnership agreement is entered into with the Company; and/or (ii) company(ies), institution(s) or entity(ies) in any form, French or foreign, which conduct a significant portion of their business in these sectors or in the field of cosmetics or chemicals or medical devices or research in these fields, or having entered into an industrial commercial, licensing, research or partnership agreement with the Company, in accordance with the 25th resolution of the annual general meeting of June 19, 2023 (the "AGM") and pursuant to article L. 225-138 of the French Commercial Code
a public offering of new ordinary shares, aimed at retail investors via the PrimaryBid platform, which will be carried out via an allocation proportional to demand, limited to the amount allocated to this public offering, with allocations reduced should demand exceed this limit, in accordance with the 23rd resolution of the AGM and pursuant to article L. 225-136 of the French Commercial Code and article L. 411-2-1 1° of the French Monetary and Financial Code (the "PrimaryBid Offering") , and
a sale of up to 125,000 existing ordinary shares representing a maximum amount of 1 Million euros held by the Selling Shareholder to the same specific categories of investors defined in the Reserved Offering.
The total amount of the Global Offering would be approximately 18 million euros, with a possibility to increase this total amount, subject to investor demand.

The amount of the Global Offering will depend exclusively on the orders received for each of the above-mentioned components, with no possibility of reallocating the amounts committed to the Reserved Offering and the Secondary Offering, to the PrimaryBid Offering. The PrimaryBid Offering to retail investors is incidental to the Reserved Offering and may not exceed 20% of the total amount of the Global Offering. In any event, the PrimaryBid Offering will not be carried out if the Reserved Offering does not occur.

The Offering Price of the new shares will be at a price of €8 per share, representing an approximate discount of 15% of the Company’s shares on the Euronext Paris regulated market at the time of the last trading session preceding announcement (i.e. May 13, 2024), in compliance with the 25th, 23rd and 27th resolutions of the Company. The Offering Price of the new ordinary shares issued under the PrimaryBid Offering and of the existing shares sold in the Secondary Offering will be equal to the price of the new ordinary shares issued under the Reserved Offering.

The Reserved Offering and the Secondary Offering will be carried out by "accelerated bookbuilding", at the end of which the number of new shares to be issued and the price per share will be determined by the Chief Executive Officer of the Company, pursuant to and within the limits of the sub-delegations of au thority granted by the Board of Directors of the Company as of the date of this press release and in accordance with the resolutions of the AGM.

The accelerated book-building process for the Reserved Offering and the Secondary Offering will be initiated immediately following the publication of this press release and is expected to close before markets open tomorrow, subject to early closing. The PrimaryBid Offering will also begin immediately and is expected to close at 10 p.m. today, subject to early closing. The Company will announce the results of the Global Offering by press release after the order book closes, tomorrow before the market opens.

The Reserved Offering will be available, within the categories of investors defined above, (i) to institutional investors in France, outside France with the exception of the United States, Canada, Australia and Japan and, solely within the categories of investors specifically provided for in the 25th resolution mentioned above, and (ii) to certain institutional investors in the United States.

Settlement-delivery of the new ordinary shares and their admission to trading on the regulated market of Euronext Paris are expected to occur on May 17, 2024. The new shares will be of the same class and fungible with the existing shares, will carry all rights attached to the shares, and will be admitted to trading on the Euronext Paris market under the same ISIN code FR0012634822 – MAAT.

Shareholders’ subscription and lock-up agreements

Current shareholders Bpifrance Investissement, Biocodex and Seventure Partners which hold 15,51%, 10,62% and 22,31% of the Company’s share capital, respectively on a non-dilutive basis, have pledged to subscribe €8 million, €5 million and €1.3 million respectively in the Reserved Offering, subject for the Reserved Offering representing at least €17 million. The Management of the Company has pledged to subscribe €100,000 in the Reserved Offering.

The subscription commitments received by the Company, as detailed above, thus represent a total of €14.4 million.

The press release announcing the results of the Global Offering will set out the shareholding resulting from the transaction.

The independent directors of the Company were called upon to vote alone on the transaction, unanimously approved both the principle of the transaction and its terms. Mr. Hervé Affagard, Mrs Isabelle de Crémoux for Seventure Partners, and Mr. Jean-Marie Lefèvre for Biocodex, did not take part in the vote of this decision.

In connection with the Reserved Offering, participating Directors and certain existing shareholders namely, Seventure Partners, Biocodex and Bpifrance Investissement have respectively entered into a lock-up agreement with the Placement Agent for a period ending 90 days after the settlement and delivery date of the Offering, subject to customary exceptions. In connection with the Reserved Offering, the Company has undertaken to refrain from issuing shares for a period of 90 days from the settlement-delivery date of the Offer, subject to customary exceptions.

Financial Intermediaries

Stifel Europe AG ("Stifel") are acting as Global Coordinator and Joint Bookrunner in connection with the Reserved Offering. Gilbert Dupont SNC, Groupe Société Générale, is acting as Joint Bookrunner in connection with the Reserved Offering. Stifel is also acting as Centralizing Agent (together, the "Placement Agents"). The Reserved Offering is subject to a placement agreement entered into between the Company and the Placement Agents dated May 14, 2024.

Within the framework of the PrimaryBid Offering, investors may only subscribe via the PrimaryBid Partners mentioned on the PrimaryBid website. The PrimaryBid Offering is subject to an engagement letter entered into between the Company and PrimaryBid and is not subject to a placement agreement.

Prospectus

In connection with the Reserved Offering, a listing prospectus will be submitted to the Autorité des Marchés Financiers (the "AMF") prior to the settlement and delivery of the new ordinary shares (the "Prospectus"). The Prospectus will consist of (i) the Company’s universal registration document filed with the AMF on April 2, 2024, under number D.24-0225, with its amendment to be filed with the AMF, and (ii) a securities note including the summary of the Prospectus. This Prospectus will be available on the AMF’s website (www.amf-france.org) and on the Company’s website (www.maatpharma.com/) and may be obtained free of charge from the Company’s registered office.

This press release does not constitute a prospectus under Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017, as amended, or a public offering.

Risk factors

The public’s attention is drawn to the risk factors relating to the Company and its business, presented in chapter 3 of the universal registration document 2024 approved by the Autorité des marchés financiers on April 02, 2024, which is available free of charge on the Company’s website (www.maatpharma.com) and the website of the Autorité des marchés financiers (www.amf-france.org). The occurrence of any or all of these risks could have an adverse effect on the Company’s business, financial situation, results, development or prospects.

In addition, investors are invited to consider the following risks specific to the issue: (i) the market price of the Company’s shares could fluctuate and fall below the Offering Price of the shares issued under the Offer, (ii) the volatility and liquidity of the Company’s shares could fluctuate significantly, (iii) sales of the Company’s shares could occur on the market and have an unfavorable impact on the Company’s share price, and (iv) the Company’s shareholders could suffer potentially significant dilution as a result of any future capital increases made necessary by the Company’s search for financing.

Instylla Completes Enrollment of Landmark Hypervascular Tumor Pivotal Study

On May 14, 2024 Instylla, Inc., a privately held clinical-stage company focused on developing liquid embolics for peripheral vascular embolotherapy, reported the completion of patient enrollment in the ongoing Instylla HES Hypervascular Tumor Pivotal Study (Press release, Instylla, MAY 14, 2024, View Source [SID1234643193]).

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The Instylla HES Hypervascular Tumor Pivotal Study is a prospective, multicenter, randomized clinical study to evaluate the safety and effectiveness of Instylla’s Embrace Hydrogel Embolic System (HES) compared with standard of care transcatheter arterial embolization or transcatheter arterial chemoembolization for the vascular occlusion of hypervascular tumors. A wide variety of tumors were treated in the study including primary and metastatic liver tumors, metastatic bone tumors, and renal tumors.
Dr. Nadine Abi-Jaoudeh, the study’s National Principal Investigator and Chief of Interventional Radiology at the University of California, Irvine, said, "Congratulations to all the investigators, study coordinators, and the Instylla team on the completion of enrollment for the Instylla HES Hypervascular Tumor Pivotal Study. This marks an exciting milestone in the field of embolization of hypervascular tumors. We hope the study will be positive and demonstrate that this next-generation liquid embolic technology will improve the lives of our patients who have to navigate their challenging clinical conditions. We want to thank all the patients that participated."

"Enrollment completion represents a significant milestone for Instylla and cancer patients diagnosed with hypervascular tumors," said Amar Sawhney, CEO of Instylla, Inc. and Managing Director of Incept, LLC. "We look forward to continuing to work with the study investigators to maintain the high quality of patient follow-up as we continue on our pathway to a PMA for Embrace HES."

About Embrace Hydrogel Embolic System:
Embrace HES is an investigational device intended to embolize hypervascular tumors in vessels ≤ 5 mm. Embrace HES consists of two injectable liquid precursors that solidify when simultaneously delivered into blood vessels, forming a soft hydrogel that fills the vessel lumens during embolization. The Embrace HES embolization uses no organic solvents, does not need sizing to the vessel diameter, and eliminates the possibility of catheter entrapment. Its main components are water and polyethylene glycol (PEG).

HUTCHMED Initiates Phase II/III Trial of the Combination of Surufatinib and Camrelizumab for Treatment-Naïve Pancreatic Ductal Adenocarcinoma in Collaboration with Hengrui

On May 14, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported the initiation of a Phase II/III trial to evaluate the efficacy of a combination of the HUTCHMED drug candidate surufatinib, the Jiangsu Hengrui Pharmaceuticals Co., Ltd ("Hengrui Pharma") PD-1 antibody camrelizumab, nab-paclitaxel and gemcitabine as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma ("PDAC") in China (Press release, Hutchison China MediTech, MAY 14, 2024, View Source [SID1234643170]). PDAC is an exocrine tumor and the most common form of pancreatic cancer. The first patient received the first dose on May 8, 2024.

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PDAC is a highly aggressive form of cancer, representing over 90% of pancreatic cancer cases. Globally, an estimated 511,000 people were diagnosed with pancreatic cancer, leading to approximately 467,000 deaths in 2022, with an average five-year survival rate of less than 10%. In China, an estimated 119,000 people were diagnosed with pancreatic cancer, causing approximately 106,000 deaths in 2022.[1] Treatments such as chemotherapy, surgery and radiation are commonly employed, but have not shown significant improvement in patient outcomes. Under 20% of metastatic pancreatic cancer patients survive more than a year.[ii]

The trial is a multicenter, randomized, open-label, active-controlled, Phase II/III trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as a treatment for adults with metastatic pancreatic cancer who have not been previously treated with a systemic anti-tumor therapy. After an initial safety run-in stage, the Phase II/III stage of the study may enroll a further 500 patients, with a primary endpoint of overall survival (OS). Other endpoints include objective response rate (ORR), progression free survival (PFS), disease control rate (DCR), safety, quality of life, duration of response and time to response. Additional details may be found at clinicaltrials.gov, using identifier NCT06361888.

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, "Emerging data including those from an investigator-initiated study presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, demonstrated that combinations of surufatinib, camrelizumab and chemotherapy have promising efficacy in comparison with existing chemotherapy-based treatments in metastatic PDAC.[3] We hope that this partnership will enable us to bring new, potentially life-changing treatment options to patients."

About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFRs) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA, and was first included in the China National Reimbursement Drug List (NRDL) in January 2022 for the treatment of non-pancreatic and pancreatic neuroendocrine tumors (NETs).

About Camrelizumab
Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Currently, more than 10 clinical trials are underway worldwide in a broad range of tumors and treatment settings.

Camrelizumab, under the brand name AiRuiKa, is currently approved for nine indications in China, including hepatocellular carcinoma ("HCC") (second-line and first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, and nasopharyngeal carcinoma in the first-line setting. All indications have been included in China’s national medical insurance catalog, making it the leading domestic PD-1 product in terms of approved indications and tumor types covered. The U.S. Food and Drug Administration ("FDA") granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021, and accepted a New Drug Application (NDA) for camrelizumab and rivoceranib as a first-line therapy for unresectable HCC, with FDA Prescription Drug User Fee Act (PDUFA) dates in May 2024.