On March 20, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported that it has commenced a proposed underwritten public offering of common stock of the Company, together with warrants to purchase shares of common stock (Press release, Oragenics, MAR 20, 2019, View Source [SID1234534524]). In addition, the Company expects to grant the underwriter of the offering, a 30-day option to purchase additional shares of common stock and/or warrants at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and 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.

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

The Company intends to use the net proceeds of the offering to fund its AG013 research, clinical trials, pre-clinical development of the lantibiotics program, and for working capital and general corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-213321), which was declared effective by the United States Securities and Exchange Commission ("SEC") on September 7, 2016. A preliminary prospectus supplement relating to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, at the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and accompanying prospectus also may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, email: [email protected].

Before you invest, you should read the preliminary prospectus supplement and the accompanying prospectus in the registration statement and other documents Oragenics has filed or will file with the SEC for more complete information about Oragenics and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s 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.

On March 20, 2019 Xynomic Pharmaceuticals, Inc. ("Xynomic"), a clinical stage US-China oncology drug development company, and Bison Capital Acquisition Corporation (Nasdaq: BCAC), jointly reported that Xynomic and its collaborators will present at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") 2019 Annual Meeting to be held in Chicago from May 31, 2019 – June 4, 2019 (Press release, Xynomic Pharmaceuticals, MAR 20, 2019, View Source [SID1234534943]). The presentation will show Phase 1 data of XP-105 (also known as BI 860585), Xynomic’s Phase 2 ready, ATP-competitive, third generation mTORC1/2 Inhibitor, used alone or in combination with exemestane or paclitaxel in patients with advanced solid tumors. XP-105 is a potent dual inhibitor designed to overcome mTORC1 inhibition resistance. An oral presentation titled "A Dose Escalation Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of mTORC1/2 Inhibitor XP-105 (BI 860585) as Monotherapy and in Combination with Exemestane or Paclitaxel in Patients (pts) with Advanced Solid Tumors" will be presented by Dr. Filippo G. De Braud, a lead investigator at Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. This Phase 1 trial enrolled a total of 90 patients; 41 were in Arm A where XP-105 was used as a monotherapy (the "monotherapy arm"), 25 were in Arm B where XP-105 was used in combination with exemestane (the "exemestane combination arm"), and 24 were in Arm C where XP-105 was used in combination with paclitaxel (the "paclitaxel combination arm"). Combination regimens showed higher activity as compared to monotherapy. In the monotherapy arm, stable disease ("SD") was reported in 8 pts (20%), with a median duration of 11 months. In the exemestane combination arm, 4 (16%) partial responses ("PR") were reported. In the paclitaxel combination arm, 1 complete response ("CR") and 4 PRs were reported (OR rate 21%). Disease control rate (CR/PR/SD) was 20%, 28%, and 58% in the monotherapy, XP-105/exemestane, and XP-105/paclitaxel arms, respectively. In the XP-105/paclitaxel combination the most frequent drug-related adverse events ("AEs") were diarrhea and fatigue (58.3% each), hyperglycaemia (54.2%), and anaemia (50%). Grade ≥3 AEs were hyperglycaemia, fatigue, diarrhea, anaemia, and leukopenia.

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In addition, Xynomic will sponsor an investigator meeting on Friday, March 22, 2019 in Athens, Greece. The investigator meeting will bring together European Union ("EU") physicians, care providers and clinical research coordinators. The participants are from current and prospective clinical trial sites in the potentially pivotal Phase 3 clinical trial of testing Xynomic’s abexinostat, in combination with pazopanib, against renal cell carcinoma. The participants will be presented with trial design, protocol, and study management as a part of the preparation of the trial start and patient recruitment.

Furthermore, Xynomic’s board of directors has appointed Ms. Jinwei Coco Kou as the Interim Chief Accounting Officer. Ms. Kou is responsible for overseeing all accounting functions such as ledger accounts, financial statements, and cost control systems. Before joining Xynomic, Ms. Kou had extensive experience in internal controls, multinational operations and corporate finance of high-tech companies. From 2017-2018, Ms. Kou was the Chief Financial Officer at Salion Food Condiment Company Limited (a company approved for listing by the Hong Kong Stock Exchange). From 2008-2016, she was a Managing Director at Marcum Bernstein & Pinchuk LLP, one of the largest independent public accounting and advisory services firms in the United States, with multinational offices. From 2005-2008, Ms. Kou worked for Deloitte Touche Tohmatsu. Ms. Kou is a CPA in both the United States and China. Ms. Kou holds a Bachelor degree in Economics majoring in Finance, and a Master’s degree in Economics majoring in Risk Management and Insurance, both from Peking University. Ms. Kou holds an Executive MBA degree jointly granted by Columbia Business School, London Business School and Hong Kong University Business School.

On March 20, 2019 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM), reported that preclinical data from the novel combination of its CD33 ARC or Antibody Radiation-Conjugate Actimab-A (lintzumab-Ac-225) with venetoclax has been accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper), or AACR (Free AACR Whitepaper), Annual Meeting 2019 (Press release, Actinium Pharmaceuticals, MAR 20, 2019, View Source [SID1234534505]). The data to be presented builds on research by Actinium that demonstrated a synergy between Actimab-A and venetoclax, which resulted in greater cancer cell killing. This research supported the initiation of a Phase 1/2 doublet clinical trial studying Actimab-A and venetoclax and a planned Phase 1/2 triplet combination trial of Actimab-A and venetoclax with a hypomethylating agent, both for patients with relapsed or refractory AML or Acute Myeloid Leukemia. Actinium is conducting these trials with the goal of improving outcomes for patients with the addition of Actimab-A to address patients who do not respond, have suboptimal responses, no longer respond and patients who relapse after treatment with venetoclax.

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Venetoclax is a BCL-2 or B-Cell Lymphoma 2 inhibitor jointly developed and marketed by AbbVie and Genentech. BCL-2 is one of several proteins encoded by the BCL2 gene that regulates apoptosis or programmed cell death. MCL-1 is another protein encoded by the BCL2 gene that has been found to be overexpressed in relapsed or refractory AML patients, that prevents apoptosis and promotes resistance to venetoclax which does not bind to MCL-1. It has been observed that MCL-1 levels can be depleted with radiation, but only external radiation was used in these studies. Actinium believes that the targeted internalized radiation from Actimab-A can more effectively deplete MCL-1 levels thereby removing the AML cells’ resistance mechanism and rendering them more susceptible to venetoclax. Actinium has filed a patent on the combination of a targeted alpha-emitting therapeutic such as Actimab-A together with a BCL-2 inhibitor, which includes venetoclax, as a method to treat cancer. The details on Actinium’s poster are as follows:

Title: 225Ac-CD33 Radioimmunotherapy potently increases the sensitivity of resistant acute myeloid leukemia lines to the Bcl-2 inhibitor venetoclax by mediating a reduction in cellular Mcl-1 levels

Session Category: Experimental and Molecular Therapeutics
Session Title: Drug Resistance 5
Session Date and Time: Tuesday Apr 2, 2019 1:00 PM – 5:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 10
Poster Board Number: 13
Abstract Number: 3808

Dr. Dale Ludwig, Actinium’s Chief Scientific Officer said, "We are excited to present new data from this Actimab-A ARC and venetoclax combination to further support our recently initiated clinical study and prior work. We have high confidence in the mechanistic rationale of the Actimab-A and venetoclax combination and are encouraged by the results we have seen thus far. With radiation being used in the treatment of up to 60% of cancer patients and a growing body of literature supporting the synergies of radiation therapy with other modalities, we are motivated to capitalize on numerous opportunities that can leverage our AWE or Antibody Warhead Enabling technology platform to exploit radiation’s synergistic effects. Indeed, our AWE technology platform is a tool for innovation that has the potential to expand our pipeline and facilitate collaborations and partnerships."

Actimab-A delivers the potent alpha-particle emitting radioisotope Ac-225 or Actinium-225 to cells with the CD33 antigen, which is expressed in the vast majority of patients with AML, MDS or Myelodysplastic Syndrome, and 25-35% of patients with Multiple Myeloma, or MM. Venetoclax is a BCL-2 or B-Cell Lymphoma 2 inhibitor that is jointly developed and marketed by AbbVie and Genentech that is approved for patients with AML, Chronic Lymphocytic Leukemia, and Small Lymphocytic Leukemia. Actinium has initiated a Phase 1/2 trial that is studying Actimab-A in combination with venetoclax for patients with relapsed or refractory AML and is planning a Phase 1/2 trial that is expected to study Actimab-A and venetoclax with a hypomethylating agent also for patients with relapsed or refractory AML.

Dr. Mark Berger, Actinium’s Chief Medical Officer said, "Our Actimab-A venetoclax combination trials are a strategic priority within our CD33 program that demonstrate our ability to rapidly translate research from our AWE technology platform to our clinical pipeline. Our preclinical data demonstrating a synergy between targeted radiation from Actimab-A and venetoclax, together with Actimab-A’s single agent activity and minimal extramedullary toxicities was well received by investigators, allowing us to develop two distinct clinical trials with this novel combination. As a result, we have created multiple opportunities to advance the treatment of patients with unmet needs with our ARC approach."

On March 20, 2019 Apexigen, Inc., a clinical-stage biopharmaceutical company, reported new clinical data on APX005M will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held March 29 – April 3, 2019 in Atlanta, GA. Apexigen’s lead immuno-oncology (I-O) therapeutic APX005M, a monoclonal antibody targeting CD40, is being evaluated in multiple ongoing clinical trials in different types of solid tumors (Press release, Apexigen, MAR 20, 2019, View Source [SID1234590997]).

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Plenary Session Presentation Title: A Phase 1b Study of CD40 Agonistic Monoclonal Antibody APX005M Together with Gemcitabine (Gem) and nab-Paclitaxel (NP) with or without Nivolumab (Nivo) in Untreated Metastatic Ductal Pancreatic Adenocarcinoma (PDAC) Patients (Abstract CT004)
Presenter: Mark O’Hara, M.D., Assistant Professor of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
Plenary Session Date and Time: Sunday, March 31, 2019 2:25 PM – 2:45 PM ET
Plenary Session: Clinical Trials Plenary Session 1
Location: Georgia World Congress Center, Building A, Marcus Auditorium

Late-breaking Abstract Title: Phase Ib/II of CD40 agonistic antibody APX005M in combination with nivolumab (nivo) in subjects with metastatic melanoma (M) or non-small cell lung cancer (NSCLC) (Abstract CT089)
Poster Session Date and Time: Monday, April 1, 2019 1:00 PM – 5:00 PM ET
Poster Session: Phase 1 Clinical Trials, Part 3
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 16

About APX005M
APX005M is a humanized monoclonal antibody designed to stimulate the anti-tumor immune response. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of APX005M to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) is believed to initiate a multi-faceted immune response that enables multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as melanoma, non-small cell lung cancer, pancreatic cancer, esophageal and gastroesophageal junction cancers and renal cell carcinoma and pediatric brain cancer in various combinations with immunotherapy, a cancer vaccine, chemotherapy or radiation therapy. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov.

On March 20, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported the financial results for the financial year ended 31 December 2018, presenting all material reporting period developments and provides an outlook for 2019. The full report is available at 4SC’s website (Press release, 4SC, MAR 20, 2019, View Source [SID1234534507]).

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Key highlights of 2018 and 2019 YTD

4SC continued to make solid progress on clinical development of both resminostat and domatinostat (4SC-202)
More than two thirds of patients recruited for pivotal RESMAIN study of resminostat in advanced-stage cutaneous T-cell lymphoma (CTCL); positive safety outcomes to date
Phase II study of resminostat plus S-1 chemotherapy versus S-1 chemotherapy plus placebo as second-line treatment in Japanese patients with biliary tract cancer initiated by Yakult Honsha Co., Ltd. (Yakult Honsha), 4SC’s development partner for resminostat in Japan
Completed second dose cohort of Phase Ib/II study SENSITIZE of domatinostat in combination with pembrolizumab in advanced-stage melanoma; positive safety outcomes to date; third dose cohort started
Initiated investigator-initiated Phase II study EMERGE of domatinostat in combination with avelumab in microsatellite-stable gastrointestinal tumors
Published preclinical data on combination of domatinostat with either chemotherapy or several immunotherapeutic agents leading to evaluation of further clinical combination trials
Strengthened patent protection for Hedgehog/GLI signaling inhibitor 4SC-208 in the U.S., China, Japan, Singapore, Australia and New Zealand.
Received milestone payments from several partnered programs.
Jason Loveridge, Ph.D., CEO of 4SC, said: "4SC continues to make excellent progress with the development of our portfolio of drug candidates.

We expect that the two ongoing clinical trials of domatinostat will provide clinical evidence to further support the efficacy of domatinostat in patients that do not benefit from immunotherapeutic treatment with checkpoint inhibitors (SENSITIZE study, melanoma) or in a historically checkpoint inhibitor non-responsive indication (EMERGE study, microsatellite-stable gastrointestinal cancer). Taken together, we expect these studies to drive initiation of a pivotal clinical study of domatinostat in the aggressive rare skin cancer Merkel-cell carcinoma.

For resminostat, we expect to enroll sufficient patients in the pivotal RESMAIN study in 2019 to observe the required 125 events to unblind the study. Should the trial prove positive, we plan to submit applications for marketing approval of resminostat in CTCL in Europe, and potentially the U.S., and Yakult Honsha will submit in Japan. If approved, resminostat would be the first histone deacetylase inhibitor approved for CTCL in Europe and the first and only drug approved for maintenance therapy in this indication in either Europe, Japan or the U.S.

The main goal of all our activities is to create significant benefit for patients and value for our shareholders by bringing resminostat and domatinostat to market as soon as possible."

Business outlook

Top-line data of the pivotal RESMAIN study expected in H1 2020.
Results of Yakult Honsha’s Phase II study of resminostat in biliary tract cancer to be available by mid-2020.
SENSITIZE study expected to complete in H1 2019.
Safety data of EMERGE expected in Q2 2019 and early efficacy data in H2 2019
Expand clinical development for domatinostat and initiate potentially pivotal study in Merkel-cell carcinoma
Cash balance development in full year 2018 and financial forecast

As of 31 December 2018, 4SC holds cash balance/funds of €25.0 million, as compared to €41.3 million as of 31 December 2017. The average monthly use of cash from operations in 2018 was €1.357 million (2017: €0.723 million), which is within the €1.3 million to €1.5 million forecast in the previous Q3 announcement. The increase of the monthly use of cash and the decrease in cash balance/funds in 2018 was mainly driven by investments in the ongoing clinical studies RESMAIN and SENSITIZE.

Taking into account the current financial planning and the intended operating activities, the Management Board estimates that current funds should be sufficient to finance 4SC for the next twelve months. For 2019, 4SC is expecting an average monthly use of cash from operations of between €1.4 million and €1.6 million. For 2019, 4SC expects the net loss to be similar to 2018. 4SC is expecting to report similar annual net losses, with almost identical functional cost allocations in the short to medium term future as well.

Conference call

Investors, financial analysts, and journalists interested in participating in the conference call on the annual results 2018 can access via the telephone numbers stated below. Please join the event conference 5-10 minutes prior to the start time. You will be asked to provide your name, company and location as well as the access code.

Date: 20 March 2019
Time: 3 pm CET (10 am ET)
Phone Numbers: +49 (0)32 22109 8334 (Germany)
+44 (0)20 3936 2999 (United Kingdom)
+1 845 709 8568 (USA)
Joining by web (free of charge): www.incommuk.com/customers/online
Access Code: 802724

A presentation document supporting the conference call will be available earlier on the same day at 4SC’s website. After the event, a replay can be accessed from there as well.