On August 11, 2020 Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, reported that members of its management team will participate virtually in the BTIG Biotechnology Conference on Tuesday, August 11, 2020 at 2:30 p.m. EDT (Press release, Tiziana Life Sciences, AUG 11, 2020, View Source [SID1234568594]).

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To access a live webcast of the fireside chat please register for the BTIG Biotechnology Conference, using the link here. The investor presentation can be found on the Tiziana website, here. A replay of the webcast will be archived on Tiziana’s website for approximately 45 days following the presentation.

On August 11, 2020 Leica Biosystems, a global leader in pathology workflow solutions, reported the European launch of its Aperio GT 450 DX digital pathology scanner (Press release, kreatech, AUG 11, 2020, View Source [SID1234563692]). This next generation imaging system was unveiled at the highly successful Leica Biosystems Digital Pathology Virtual Summit and is already installed at the Centre of Excellence at Leeds Teaching Hospitals NHS Trust NHS, UK.

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During the summit, nearly 3,000 virtual attendees joined thought leaders from around the globe to hear about the latest topics and advances in digital pathology. The featured attraction: the Aperio GT 450 DX Scanner. Combining patented real-time focusing with custom-designed Leica objectives, it delivers excellent image quality and rapid scanning. This breakthrough technology enables laboratories to scale up digital pathology for high-throughput, routine diagnostics.

Dr. Darren Treanor, Consultant Pathologist, Leeds Teaching Hospitals NHS Trust, UK and Director of Northern Pathology Imaging Co-operative (NPIC), was a presenter at the summit, discussing Digital Pathology and Artificial Intelligence in the NHS, and also spearheads digital pathology in NPIC, Leeds, who are the recipient of the first Aperio GT 450 DX Scanner in Europe.

"Our goal with the Aperio GT 450 DX System is to have a platform for high quality, standardised, 100% scanning for NPIC across 6 hospitals linked by a central PACS system," stated Dr. Treanor. "Digital Pathology will lead in the application of Artificial Intelligence (AI) in healthcare, improving the quality and speed of pathology services for patients globally. The NHS is an ideal environment for the development of AI – the NPIC vision is to be at the forefront of digital pathology and AI adoption, while maintaining strong foundations in routine clinical practice."

"Artificial intelligence and digital pathology for clinical diagnosis have long been an integral part of our strategic roadmap," said Colin White, Global Vice President, Advanced Staining and Imaging at Leica Biosystems. "The practice of pathology will be transformed with the integration of whole slide images, advanced algorithms, and big data integrated into the PACS. We are excited that the Aperio GT 450 DX delivers the technology that will allow healthcare professionals to realize their long-term vision, while providing immediate benefits in primary diagnosis such as improved throughput, reduced turnaround times and high-quality images."

Leica Biosystems Virtual Digital Pathology Summit – On-Demand Presentations:
Leeds Teaching Hospital presentations (in the auditorium): Chloe Knowles will discuss Laboratory quality assurance and ISO accreditation for DP, Bethany Williams will touch upon Maintaining Lab and Clinical Quality With Digital Diagnosis and Darren Treanor will exchange ideas on digital pathology and artificial intelligence in the NHS. Fourteen additional On-Demand digital pathology presentations are available.

The clinical use claims described for the products in the information supplied have not been cleared or approved by the U.S. FDA or are not available in the United States.

On August 11, 2020 Working with an international team of researchers, HonorHealth Research Institute and the Translational Genomics Research Institute (TGen), an affiliate of City of Hope,reported that were instrumental in one of the first clinical trials showing how pancreatic cancer patients can benefit from immunotherapy, according to a four-year study published in a premier scientific journal, Nature Medicine (Press release, TGen, AUG 11, 2020, View Source [SID1234563691]).

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The "COMBAT trial" (NCT02826486) is a prospective, open label, phase IIa clinical trial for patients with metastatic pancreatic cancer, meaning their cancer had spread to other parts of the body. Patients were given pembrolizumab, an immune therapy drug, in combination with BL-8040, an agent that makes the tumor microenvironment more receptive to immune therapy.

The study was conducted in Arizona at the HonorHealth Research Institute and at 30 other locations in the U.S. and across the globe, including Spain, Israel and South Korea.

The two-part clinical trial began in September 2016:

Cohort 1, a group of 37 patients whose cancer had already progressed on other therapies, were treated with pembrolizumab and BL-8040. Importantly, it appeared this combination therapy made pancreatic cancer more "hot," meaning it could work in tandem with the body’s own immune system. Previous studies have shown pancreatic tumors to be "cold," meaning immune therapies like pembrolizumab were not able to act on the cancer.
Preliminary results of Cohort 2 were reported in the manuscript on a group of 22 patients (out of approximately 40 patients in total expected in the cohort), who had previously received one line of chemotherapy. These patients received pembrolizumab and BL-8040, as well as chemotherapy drugs 5-fluorouracil and nano-liposomal irinotecan.
"The percentage of meaningful tumor shrinkage was 32% in Cohort 2, which is double what is available for individuals with pancreatic cancer with traditional chemotherapy. While the study is small, these preliminary results are encouraging and there is hope that we will be able to do larger trials to see if the response to therapy is high and if it is better in comparison to traditional treatment," said Erkut Borazanci, M.D., M.S., a medical oncologist and physician-investigator at HonorHealth Research Institute, a clinical associate professor at TGen, and one of the paper’s authors.

This clinical trial is currently in a follow-up phase of the study.

Pancreatic cancer is an aggressive disease that carries a high mortality rate. It is the third-leading cause of cancer death in the U.S., following lung and colorectal cancers. In 2020, the five-year survival rate for pancreatic cancer is 10%, which has increased from 6% in 2014.

Next steps for this research would be to compare this COMBAT combination therapy in future studies to other treatment options, such 5-fluorouracil, leucovorin and nano-liposomal irinotecan.

COMBAT derives its name from letters in one of the study’s descriptions: Combination of BL-8040 and Pembrolizumab in Patients with Metastatic Pancreatic Cancer.

The COMBAT treatment continues at the HonorHealth Research Institute. For more information, please go to HonorHealth.com/research, call 480-323-1339 or email [email protected].

This research is supported by BioLineRx Ltd.

The study – BL-8040, a CXCR4 antagonist, in combination with pembrolizumab and chemotherapy for pancreatic cancer: the COMBAT trial – was published May 25, 2020, in Nature Medicine.

On August 11, 2020 Horizon Therapeutics plc (Nasdaq: HZNP) reported the closing of its underwritten public offering of 13,570,000 of its ordinary shares at a price to the public of $71.00 per share (Press release, Horizon Therapeutics, AUG 11, 2020, View Source [SID1234563522]). This includes the exercise in full by the underwriters of their option to purchase up to 1,770,000 additional ordinary shares. The net proceeds to the Company from this offering are expected to be approximately $919.3 million, after deducting underwriting discounts and other estimated offering expenses payable by the Company. Following the closing of the offering, there were 220,346,699 ordinary shares of the Company outstanding as of August 11, 2020.

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Citigroup, Morgan Stanley, J.P. Morgan, Piper Sandler and Stifel acted as joint book-running managers for the offering. Cowen acted as a financial advisor to the Company for the offering.

A registration statement relating to the ordinary shares described above was previously filed with and became effective by rule of the Securities and Exchange Commission ("SEC"). A final prospectus supplement and accompanying prospectus related to the offering was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website or by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by phone at 800-831-9146; Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department or by email at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected] or by phone at 866-803-9204; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by email at [email protected] or by phone at 800-747-3924; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by email at [email protected] or by phone at 415-364-2720.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the shares in any state or other jurisdiction 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 August 11, 2020 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three and six months ended June 30, 2020 and provided a business update (Press release, Altimmune, AUG 11, 2020, View Source [SID1234563521]).

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"We are pleased with Altimmune’s progress during 2020 as we have launched two new product candidates for COVID-19, progressed our NASH candidate toward clinical testing and forged strategic alliances with Vigene Biosciences and DynPort Vaccine Company" said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "With the support of our shareholders, we now have more than $200 million of cash and investments on hand to drive continued development of our product pipeline."

Recent Highlights

Received gross proceeds of $199.4 million from a public offering, warrant exercises and ATM sales since Q1 2020
Since the first quarter, the Company has received $132.2 million in gross proceeds from a public offering of common stock and pre-funded warrants, $40.9 million from warrant exercises and $26.3 million in gross proceeds from ATM sales. The cash received will be used primarily for the development of AdCOVID and T-COVID, including scale up of manufacturing and advanced clinical trials; the continued development of ALT-801, a dual GLP-1/glucagon receptor agonist for the treatment of non-alcoholic steatohepatitis (NASH), including the first-in-human trial later this year; and for capital expenditures and general working capital purposes.

Announced positive preclinical results for AdCOVID
The Company announced positive results from the preclinical studies of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. The studies, which were conducted in collaboration with the University of Alabama at Birmingham (UAB), showed strong serum neutralizing activity and potent mucosal immunity in the respiratory tract. The induction of mucosal IgA antibody in the respiratory tract may be necessary to block both infection and transmission of the virus to prevent further spread of COVID-19. Based on these findings, the Company has initiated manufacturing of AdCOVID and plans to advance the vaccine candidate to a Phase 1 safety and immunogenicity study in Q4 of this year.

Announced manufacturing agreement with Vigene Biosciences for AdCOVID
The Company announced that it has entered into an agreement with Vigene Biosciences to manufacture AdCOVID, the Company’s single-dose intranasal vaccine candidate for COVID-19. Vigene, a Rockville, Maryland-based award-winning Contract Development and Manufacturing Organization, specializes in viral vectors and will deploy its capabilities to manufacture AdCOVID. Following recent positive pre-clinical data, the Company plans to start a Phase 1 clinical trial of AdCOVID in Q4 2020.

Formed teaming agreement with DynPort Vaccine Company for AdCOVID
The Company announced that it has entered into a teaming agreement with DynPort Vaccine Company (DVC), a General Dynamics Information Technology (GDIT) company, to coordinate U.S. Government funding efforts and, if successful, to provide program management, drug development activity integration, and regulatory support for AdCOVID.

Initiated T-COVID program and received $4.7 million award from the DoD to fund Phase 1/2 clinical trial
The U.S. Food and Drug Administration (FDA) authorized the Company to proceed with a Phase 1/2 clinical trial of T-COVID, an investigational therapeutic agent for the treatment of early COVID-19. The EPIC Trial (Efficacy and Safety of T-COVID in the Prevention of Clinical Worsening in COVID-19) is being funded through a $4.7 million competitive award from the U.S. Army Medical Research & Development Command (USAMRDC) and Department of Defense (DoD) working in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium. Altimmune recently initiated multiple clinical sites across the United States and expects that enrollment will commence imminently.

Completed enrollment in Phase 1b clinical trial of NasoShield
The Company completed enrollment in its Phase 1b clinical trial of NasoShield, a single dose intranasal anthrax vaccine candidate. The NasoShield program is being developed under a contract with the Biomedical Advanced Research and Development Authority (BARDA), with a total potential value of $133.7 million if all options in the contract (HHSO100201600008C) are exercised. At the conclusion of the Phase 1b NasoShield trial, BARDA will have the option of exercising the remaining contract options valued at approximately $105 million to enable Phase 2 development.

Advanced IND-enabling activities for ALT-801 GLP-1/glucagon dual receptor agonist for NASH
The Company has successfully completed the in-life portion of the safety and toxicological assessment of ALT-801 and is manufacturing the clinical trial material for the first-in-human trial, expected to start in Q4 2020. The single and multiple ascending dose trial will be conducted in Australia and will evaluate the safety and activity of ALT-801 in overweight and obese volunteers. Data from that study, including validation of the compound’s weight loss and liver fat-reducing effects, is expected to read out in the spring of 2021.

Received HepTcell IND clearance for Phase 2 trial
The FDA cleared the Company’s Investigational New Drug (IND) application to conduct a Phase 2 trial of HepTcell, a peptide-based immunotherapeutic for the treatment of chronic hepatitis B (HBV). The Company is also filing CTAs in Canada and three European countries. Altimmune plans to initiate the multinational trial in Q4 of this year, subject to an ongoing assessment of the impact of COVID-19 on study conduct.
Financial Results for the Second Quarter Ended June 30, 2020

The Company had cash, cash equivalents and short-term investments of $80.3 million at June 30, 2020. Subsequent to the quarter ended June 30, 2020, the Company received approximately $136.2 million in net proceeds from the public offering of its common stock, warrant exercises, and ATM sales.
Revenue was $0.7 million for the quarter ended June 30, 2020 compared to $1.6 million in the prior year period. The change was primarily due to a decrease in billings under the Company’s U.S. government contracts due to timing of manufacturing and clinical trials for the NasoShield program.
Research and development expenses were $16.5 million for the quarter ended June 30, 2020 compared to $2.9 million in the prior year period. The increase was primarily attributable to an increase in the contingent liability for stock-based milestone payments associated with the acquisition of ALT-801; development costs for IND-enabling preclinical studies for ALT-801; and development costs for the COVID-19 programs. These increases were partially offset by decreased spend on the NasoShield program.
General and administrative expenses were $2.5 million for the quarter ended June 30, 2020 compared to $2.2 million in the prior year period. The increase is attributable to higher employee compensation and legal costs.
Income tax benefit was $1.6 million for the three months ended June 30, 2020, as compared to zero for the same period in 2019. The increase is attributable to the Coronavirus Aid, Relief, and Economic Security Act (the "CARES Act") passed on March 27, 2020 which made temporary changes regarding the utilization and carry back of net operating losses. The Company intends to file a tax refund claim with the Internal Revenue Service reflecting a partial refund of its 2016 tax liability by carrying back net operating losses arising during the three and six months ended June 30, 2020.
Net loss attributed to common stockholders for the quarter ended June 30, 2020 was $16.8 million, or $0.94 net loss per share, compared to $3.4 million in the prior year, or $0.26 net loss per share. The difference in net loss is primarily attributable to higher research and development expenses, lower revenue, offset by an increase in income tax benefit.
Conference Call Information

Altimmune will host a conference call to discuss the company’s second quarter results and other business information.
Date: Wednesday, August 12, 2020
Time: 8:30 am Eastern Time
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13706947
Webcast: View Source
Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The company has used, and intends to continue to use, the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.