On September 25, 2019, CorMedix reported that it has entered into a Letter Agreement with several holders (each a "Holder") of several Series B Warrants issued by us on May 3, 2017, and amended on September 20, 2019 (each, a "Letter Agreement") (Filing, 8-K, CorMedix, SEP 25, 2019, View Source [SID1234551862]). Pursuant to each Letter Agreement, we agreed to reduce the exercise price of each Holder’s Series B Warrant from $5.25 to $4.00, provided that each Holder exercised its Warrant for cash at the time of entry into such Letter Agreement. In accordance with each Letter Agreement, each Holder exercised its Series B Warrant in full and we issued an aggregate of 1,224,263 shares of common stock, par value $0.001 per share, and we received proceeds of $4,897,052.

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!

On September 25, 2019 Innate Pharma SA (the "Company" or "Innate" – Euronext Paris: FR0010331421 – IPH), reported that AstraZeneca (LSE/STO/NYSE: AZN) will advance monalizumab into a Phase III randomized clinical trial evaluating monalizumab in combination with cetuximab in patients suffering from recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), and the companies will co-fund the trial (Press release, Innate Pharma, SEP 25, 2019, View Source [SID1234539800]). The trial initiation is expected in 2020, subject to regulatory and compliance approvals.

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!

"This is an important scientific milestone as we continue to invest in innovation and advance our late-stage clinical development pipeline," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Together with AstraZeneca, we are working diligently to progress this potential novel treatment for head and neck cancer patients, a population with a high unmet medical need."

About the Innate-AstraZeneca monalizumab agreement:

On April 24 2015, the Company signed a co‑development and commercialization agreement with AstraZeneca to accelerate and broaden the development of monalizumab.

The financial terms of the agreement include potential cash payments of up to $1.275 billion to Innate Pharma. The Company has already received $350 million, and the next payment due by AstraZeneca is $100 million upon dosing of the first patient in a first Phase III clinical trial. AstraZeneca will book all sales and will pay Innate low double-digit to mid-teen percentage royalties on net sales worldwide except in Europe where Innate Pharma will receive 50% share of the profits and losses in the territory. Innate will co-fund 30% of the costs of the Phase III development program of monalizumab with a pre-agreed limitation of Innate’s financial commitment.

About Monalizumab:

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Hence, monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells. Monalizumab may also enhance the cytotoxic potential of other therapeutic antibodies.

AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing Phase II development for monalizumab is focused on investigating monalizumab in combination strategies.

About Cetuximab:

Cetuximab is an anti-EGFR monoclonal antibody. NK cells mediate cetuximab-induced antibody dependent cellular cytotoxicity (ADCC) against SCCHN, and genetic and preclinical experiments suggest that ADCC can be enhanced by NK-stimulators.

The activity of cetuximab as a single agent in recurrent and/or metastatic SCCHN is limited, with a 12.6% overall response rate, a median time to progression of 2.3 months and a median overall survival of 5.8 months (Vermorken et al, JCO 2007).

On September 25, 2019 Tacalyx, a biotech company focused on the discovery and development of novel anti-TACA (Tumor Associated Carbohydrate Antigens) cancer therapies, reported that it has successfully secured €7 million in seed funding (Press release, Tacalyx, SEP 25, 2019, View Source [SID1234539794]). The funding round involves a syndicate of leading European life science and technology investors co-led by Boehringer Ingelheim Venture Fund and Kurma Partners and joined by Idinvest Partners, High-Tech Gründerfonds (HTGF), coparion, and Creathor Ventures.

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!

Tacalyx, a spin-out of the Max Planck Institute (MPI) of Colloids and Interfaces, will use the proceeds to advance its discovery platform, progress obtained leads towards candidate selection and start its pre-clinical development.

As tumor markers, TACAs are considered highly innovative targets for anticancer therapies due to their specific expression on a wider variety of tumor cells. At the same time TACAs drive tumor virulence and therefore their masking and/or down-regulation would compromise the vital functions of the tumor cell. However, because of TACAs’ low immunogenicity, the generation of antibodies against them is a challenging task and requires innovative tools as well as extensive knowledge of the employed technology.

Tacalyx’s discovery platform will allow the identification and validation of TACAs followed by the generation of leads against these difficult targets, for the implementation of novel immunotherapies that trigger an anti-cancer response more efficiently. The company combines the unique ability to synthesize sufficient amounts of ultra-pure and highly complex TACA structures with its analysis and screening capabilities and its experience in successful generation of mAb leads against non-peptidic targets.

Tacalyx secured access to licenses and the know-how from Max-Planck-Innovation GmbH to the underlying technology and related discoveries made by its scientific co-founders, Prof. Dr. Peter H. Seeberger, Director at the MPI for Colloids and Interfaces, and world leading expert in glycosciences, and Dr. Oren Moscovitz, Group leader at the MPI for Colloids and Interfaces and an expert in glyco-biology and glyco-oncology. Seeberger’s and Moscovitz’s scientific discoveries in the fields of tumor glycoscience and glycan targeting antibody generation gave rise to Tacalyx’s proprietary platform with supplementary financial support from technology transfer funds of Max-Planck-Society.

Dr. Peter Sondermann, CEO of Tacalyx, said: "This financing, by highly experienced life sciences and technology investors, represents an important validation of our platform and development strategy and will help to position us at the forefront of this breakthrough approach. Besides establishing the company and our discovery platform for lead generation, we will use these funds to explore relevant TACA biology in detail. We will also further assess and characterize our first lead antibodies and their functional role in treating cancer. Following which in vivo pharmacology studies evaluating the safety and efficacy of our lead antibodies will provide additional functional validation to progress at least one lead molecule to clinical development."

Dr. Detlev Mennerich, Investment Director at Boehringer Ingelheim Venture Fund, said: "We are pleased to have built this syndicate of leading investors to advance our mission of investing in ground-breaking therapeutics-focused biotechnology companies that drive innovation in biomedical research. Anti-TACA antibody generation requires sophisticated knowledge to produce specific high-affinity binders to TACAs. Tacalyx’s synthetic TACA chemistry, its understanding of TACA biology and ability to generate and characterize anti-TACA antibodies against these low immunogenic targets will enable the Company to realize their significant potential as treatments for multiple cancers."

In conjunction with the financing, Dr. Lena Krzyzak (High-Tech Gründerfonds), Ulrich Mahr (Max Planck Innovation), Dr. Detlev Mennerich (Boehringer Ingelheim Venture Fund), Dr. Peter Neubeck (Kurma Partners, Idinvest Partners), Dr. Sebastian Pünzeler (coparion) and Karlheinz Schmelig (Creathor) will join Tacalyx’s board of directors alongside Prof. Dr. Peter H. Seeberger (MPI for Colloids and Interfaces).

On September 25, 2019 OCTIMET Oncology NV, the Belgian life science company with a focus on accelerated development of highly selective differentiated MET kinase inhibitors is reported the recruitment of the first patient into the second module of its phase I/II clinical study in patients with advanced solid malignancies (Press release, Octimet Oncology, SEP 25, 2019, View Source [SID1234539793]).

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 Study (NCT03138083) is currently evaluating OMO-1 in a monotherapy setting as well as in combination with small molecule EGFR tyrosine kinase inhibitors (TKIs). OMO-1 is an oral, highly selective small molecule MET kinase inhibitor that has demonstrated potent single agent and combination activity in a range of preclinical models. OCTIMET obtained a worldwide exclusive license to OMO-1 from Janssen Pharmaceuticals which had previously carried out a healthy volunteer trial where predicted efficacious exposures were reached without any significant adverse events.

The primary objective of Module 2 of this Phase I/II study is to demonstrate that OMO-1, in combination with EGFR TKIs, has an acceptable safety and tolerability profile in patients with advanced MET amplified cancer types, whose tumours are progressing during treatment with an EGFR-TKI; secondary objectives include determination of pharmacokinetic (PK) characteristics, and indication of clinical efficacy at doses and schedules at or below the monotherapy recommended phase 2 dose (RP2D). Preliminary top-line results of the combination of OMO-1 with EGFR TKIs are expected in 2020.

This adaptive study, with an innovative modular design, is being conducted in different countries across Europe and the USA.

Glen Clack, CMO of OCTIMET: "MET amplification is known to be a key driver of resistance to EGFR TKIs. This study module will explore the combination of OMO-1, a differentiated selective MET kinase inhibitor, with EGFR TKIs, and provide clear clinical proof of concept data for this combination."

Shelley Margetson, CEO, of OCTIMET added: "This adaptive clinical trial with patient cohorts enriched for validated and highly relevant biomarkers is the hallmark of OCTIMET’s accelerated development approach and illustrates how we are striving to get effective drugs to the right patients as fast as possible."

About the Study, NCT03138083

The study is a modular, multi-arm, multi-part, open label, first in human study to evaluate the safety and tolerability of OMO-1, alone and in combination with anti-cancer treatments, in patients with locally advanced, unresectable or metastatic solid malignancies.

The study will consist of a number of study modules – the first of which is Module 1, a monotherapy module to be followed by further modules studying OMO-1 in combinations with other oncology drugs to address developing resistance to or progression on current treatment as well as possible synergistic effects.

In Module 1 of the first-in-patient study, OMO-1 monotherapy has shown a favourable safety profile at a recommended phase 2 dose (RP2D) of 250mg BD and a first expansion cohort for MET exon 14 mutated NSCLC patients is currently enrolling at that dose (DOI: 10.1200/JCO.2019.37.15_suppl.3062, Lolkema et al. Journal of Clinical Oncology 37, no. 15_suppl [May 20 2019] 3062-3062).

About EGFR Tyrosine Kinase Inhibitors

Lung cancer is the leading cause of cancer-related mortality worldwide. Of all lung cancer cases, 80–85% are non-small-cell lung cancers (NSCLC), and the majority of these cases are in advanced or metastatic stage (III or IV) at the time of diagnosis. Among these patients with NSCLC, a substantial number are harboring activating EGFR mutations, ranging from 10% in Europe to 38.4% in Asia. During the past years, EGFR tyrosine kinase inhibitors (TKIs) have been developed and have become standard first-line treatment for patients with EGFR mutation-positive NSCLC. Various trials showed higher response rates and improved progression-free survival (PFS) for first-line treatment with the EGFR TKIs afatinib, erlotinib, and gefitinib compared to platinum-based doublet therapy in patients with activating EGFR-mutated (exon 19 deletion or exon 21 L858R mutation) NSCLC. Recently, in head-to-head trials, the newer EGFR TKIs, dacomitinib and osimertinib, showed a significantly longer PFS compared to standard EGFR-TKIs, while dacomitinib, a second-generation EGFR-TKI, had a better efficacy compared to gefitinib, and osimertinib showed a more favorable PFS compared to standard EGFR-TKI (gefitinib or erlotinib). MET amplification is known to be a common driver of resistance to EGFR TKIs.

On September 25, 2019 Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, reported the pricing of an underwritten offering of 7,821,230 shares of its common stock (Common Stock) (or Common Stock equivalent) and common warrants to purchase up to an aggregate of 7,821,230 shares of Common Stock (the Offering), priced at-the-market (Press release, Citius Pharmaceuticals, SEP 25, 2019, View Source [SID1234539792]). Each share of Common Stock (or Common Stock equivalent) is being sold together with a common warrant to purchase one share of Common Stock at a combined effective price of $0.8951 per share and accompanying common warrant. The Company has granted the underwriter a 30-day option to purchase up to an additional 1,173,184 shares of Common Stock and/or common warrants to purchase up to 1,173,184 shares of Common Stock.

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!

H.C. Wainwright & Co., LLC is acting as the sole book-running manager for the Offering.

The common warrants will be exercisable immediately at an exercise price of $0.77 per share and will expire five years from the date of issuance. The shares of Common Stock (or Common Stock equivalent) and the accompanying common warrants can only be purchased together in the Offering but will be issued separately. The Offering is expected to close on or about September 27, 2019, subject to customary closing conditions.

The gross proceeds of the Offering are expected to be approximately $7.0 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. Citius intends to use the net proceeds from the Offering for general corporate purposes, including its Phase 3 clinical Mino-Lok trial for the treatment of catheter related bloodstream infections, the investigational new drug (IND) regulatory pathway for Mino-Wrap and its Phase 2b clinical trial of Hydro-Lido cream for the treatment of hemorrhoids, and working capital and capital expenditures.

A registration statement on Form S-1 (File No. 333-233759) relating to the securities was declared effective by the U.S. Securities and Exchange Commission (SEC) on September 24, 2019. The Offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to and describing the terms of the Offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, copies of the final prospectus relating to the Offering may be obtained for free by visiting the SEC’s website at www.sec.gov or from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at [email protected] or by telephone at 646-975-6996.

This press release shall 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 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.