On March 30, 2020 Diverse Biotech, Inc. www.diversebiotech.com reported it has signed an initial partnership agreement with The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center to study its potential new therapeutic candidates in glioblastoma (Press release, Diverse Biotech, MAR 30, 2020, View Source [SID1234576456]). The research will be performed in animal models of the disease to evaluate the efficacy and tissue distribution of Diverse Biotech’s new drug compounds.

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"We are honored to be partnering with this world-renowned center for the study and treatment of brain cancer. Glioblastoma is a disease with a large unmet patient need. Our team at Diverse Biotech wants to develop and study new drugs that could change the standard of care in this disease," said Stella Vnook, Diverse Biotech’s Chief Executive Officer.

"We are excited to be collaborating with Diverse Biotech and to evaluate their cannabidiol compounds in our GBM models. One of the main goals of our lab is to find new therapies that might improve the outcomes for patients living with this disease. Preclinical testing of novel agents is the first step in this process," said Steve Keir, DrPH, MPH, MMCI, Research Professor and Director of Translational Research at The Preston Robert Tisch Brain Tumor Center, Duke University.

On March 30, 2020 Vaccitech Ltd, a clinical stage biopharmaceutical company developing immunotherapies to treat infectious diseases and cancer, reported that its Chief Executive Officer, Bill Enright, will present an update on the Company’s progress at the upcoming Solebury Trout Virtual Investor Conference (Press release, Vaccitech, MAR 30, 2020, View Source [SID1234556135]). The presentation will include recent encouraging Phase 2 efficacy data for Vaccitech’s prostate cancer therapeutic combined with an anti-PD-1 checkpoint inhibitor in metastatic castration resistant prostate cancer patients. The presentation will also outline ongoing COVID-19 vaccine efforts using Vaccitech’s proprietary ChAdOx1 vector.

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Vaccitech is one of the few companies in the world that has data in humans demonstrating neutralizing antibodies against a coronavirus with its MERS (Middle Eastern Respiratory Syndrome) vaccine candidate.

Date of presentation: Tuesday, 31 Tuesday, 2020

Time: 10:00 am – 10:30 am ET

On March 30, 2020, Propanc Biopharma, Inc., a Delaware corporation (the "Company"),reported that it has entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") whereby an investor (the "Investor") purchased from the Company, 7,500,000 units (the "Units"), each consisting of (i) 1.5 shares of the Company’s common stock (the "Common Stock"), or pre-funded warrants (the "Prefunded Warrants") and (ii) 1.5 warrants to purchase one share of Common Stock ("Series A Warrants", and collectively with the Common Stock the "Units") (Filing, 8-K, Propanc, MAR 30, 2020, View Source [SID1234556122]). In addition to the Units, the Investor was issued 63,750,000 warrants to purchase one share of Common Stock (the "Series B Warrants") and an additional 63,750,000 warrants to purchase one share of Common Stock, subject to a vesting schedule (the "Series C Warrants" and, together with the Prefunded Warrants, the Series A Warrants, and the Series B Warrants, the "Warrants"). The aggregate purchase price for the Units, the Series A Warrants, the Series B Warrants and the Series C Warrants of $450,000 was paid at closing (the "Purchase Price"). The 11,250,000 shares of Common Stock underlying the Units issuable at closing of the Securities Purchase Agreement are comprised of 804,518 shares of restricted Common Stock and 10,445,482 Prefunded Warrants.

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The Securities Purchase Agreement contains such representations, warranties and covenants as are typical for a transaction of this nature.

Series A Warrants

Pursuant to the Securities Purchase Agreement, the Investor purchased Series A Warrants to purchase up to 11,250,000 shares of Common Stock, subject to adjustment as provided therein. The Series A Warrants have a cash exercise price of $0.20 per share. The Series A Warrants contain a provision for cashless exercise in the event there is no effective registration statement registering the shares underlying the Series A Warrants calculated based on the difference between the exercise price of the Series A Warrant and the trading price of the stock (the "Cashless Exercise").Additionally, the Series A Warrants contain a provision for a cashless conversion at the Holder’s option should the trading price of the Common Stock fall below $0.20 per share calculated based on the difference between the exercise price of the Series A Warrant and 70% of the Market Price, as defined therein (the" Alternate Cashless Exercise").

Series B Warrants

Pursuant to the Securities Purchase Agreement, the Investor purchased Series B Warrants to purchase up to 63,750,000 shares of Common Stock, subject to adjustment as provided therein; provided, however, commencing on the 90th day following the effective date, the Company may reduce the number of Warrant Shares issuable upon exercise thereof by 37,500,000 upon 10 Trading Days’ prior written notice to the Holder provided that the Company issues to the Holder 3,750,000 shares of Common Stock (or, at the election of the Holder, an equivalent number of pre-funded warrants) and Series A Warrants to purchase up to 3,750,000 shares of Common Stock, which shares shall be issued pursuant to a registration statement without restrictions on resale. The Series B Warrants have a cash exercise price of $0.04 per share. The Series B Warrants contain a provision for Cashless Exercise.

Series C Warrants

Pursuant to the Securities Purchase Agreement, the Investor purchased Series C Warrants to purchase up to 63,750,000 shares of Common Stock, subject to adjustment as provided therein. The Series C Warrants have a cash exercise price of $0.20 per share, subject to the vesting schedule set forth therein, which is based on such Holder’s exercise of the Series B Warrants. The Series C Warrants contain provisions for Cashless Exercise and Alternate Cashless Exercise.

Registration Rights Agreement

In connection with the Securities Purchase Agreement, the Company and the Investor entered into a registration rights agreement (the "Registration Rights Agreement") pursuant to which the Company agreed to register the shares of Common Stock underlying the Securities Purchase Agreement. The Registration Rights Agreement provides that the Company shall (i) use its best efforts to file with the Commission the Registration Statement within 60 days of the date of the Registration Rights Agreement; and (ii) have the Registration Statement declared effective by the Commission within 90 days of the date of the Registration Rights Agreement, or within 120 days of the date of the Registration Rights Agreement in the event of a full review by the Commission. The Registration Rights Agreement also provides that in the event of a limited or no review by the Commission, the Company shall use its best efforts to have the Registration Statement declared effective on the earlier of (i) the 90th day from the date of the Registration Rights Agreement or (ii) the fifth trading date following the Company’s receipt of notice from the Commission that the Registration Statement will not be reviewed or is no longer subject to further review and comments.

The foregoig provides only brief descriptions of the material terms of the Securities Purchase Agreement, the Registration Rights Agreement and the Warrants, and does not purport to be a complete description of the rights and obligations of the parties thereunder, and such descriptions are qualified in their entirety by reference to the full text of the forms of Securities Purchase Agreement, Registration Rights Agreement and the Warrants, respectively, filed as exhibits to this Current Report on Form 8-K, and are incorporated herein by reference.

On March 30, 2020 Bolt Biotherapeutics reported that it formally kicked off the Phase I trial of its investigational immunotherapy agent BDC-1001 in patients with HER2-expressing solid tumors (Press release, Bolt Biotherapeutics, MAR 30, 2020, View Source [SID1234556094]).

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The first-in-human, open-label study will consist of both a dose-escalation and dose-expansion portion. In the dose-escalation portion, BDC-1001 will be evaluated as a monotherapy to determine the maximum tolerated dose. To be eligible for the trial, patients must have an advanced solid tumor with documented HER2 protein expression or gene amplification.

Patients in this trial will have failed standard of care or be HER2-positive but have a lower level of HER2 expression such that current HER2 therapies are either not indicated or have not been shown to be effective.

Bolt is a privately held San Francisco-based company founded in 2015 by Ed Engleman, a professor of pathology and medicine at Stanford University School of Medicine, and co-director of the Immunology and Immunotherapy Program of the Stanford Cancer Institute. The company has venture funding from Novo Holdings, Pivotal bioVenture Partners, Vivo Capital, and Nan Fund Life Sciences. Last summer, Bolt closed a series B fundraising round of $54 million. Prior to that, it raised $16 million in a series A funding round.

The raised funds will support the development of BDC-1001, an immune-stimulating antibody conjugate (ISAC) and the lead candidate in Bolt’s pipeline. The molecule comprises trastuzumab attached to a tolllike receptor (TLR) 7/8 agonist payload that the biotech invented. The company refers to this novel type of molecule as a Boltbody. Bolt’s supply of trastuzumab comes from an agreement with a biosimilar supplier of the antibody.

The trastuzumab antibody directs the Boltbody to the HER2-expressing tumors like a GPS navigating tool. The binding of the antibody to HER2 enables the antibody to interact with corresponding receptors on myeloid dendritic cells in the tumor microenvironment. This engagement causes the myeloid cell to engulf the tumor cell and the Boltbody ISAC. Once inside the myeloid cell, the TLR activates the myeloid cell which allows it to trigger the priming and expansion of specialized T cells that can recognize tumorspecific neoantigens. The T cells are recruited to the tumor site, where it can destroy the cancer cells.

In pre-clinical studies conducted in Engleman’s lab at Stanford University, researchers found that a TLR7 and TLR8 joint stimulator was the most potent at re-awakening myeloid cells in the tumor. Another observation that researchers made was that although the TLR agonist and a tumor-targeting antibody like trastuzumab can be administered as a combination therapy, their potency was magnified when the two molecules were conjugated together.

"There was some magic that happened that really stirred up the immune system in a very specific way to target the tumor in question," said Bolt CEO Randy Schatzman.

The fastest way to prove that the Boltbody worked was to take a known antibody that is frequently used in the clinic, such as the HER2-directed drug trastuzumab, as the tumor targeting agent and attach it to the immune-stimulating payload. The anti-HER2 ISAC treatment in pre-clinical studies shrunk and cleared tumors in animal models that had a large cancer burden and that were resistant to anti-HER2 antibody treatment.

During the recently initiated Phase I trial, BDC-1001 will be evaluated in HER2-expressing patients who have failed standard-of-care HER2-targeting therapies, such as trastuzumab or Genentech’s antibodydrug conjugate ado-trastuzumab emtansine (Kadcyla). For the dose-escalation portion, investigators will monitor the drug’s safety and preliminary anti-tumor activity. They will also take various biological measurements to track whether the therapy has stimulated patients’ innate immune system to specifically recognize the cancer in question.

"In addition to treating patients who are resistant to standard of care, what treatment with these agents does in pre-clinical models is it leaves that host with an immune memory of its cancer. Should that cancer come back, the immune system will recognize it and eliminate it," Schatzman said. The treatment should do this even if the tumor metastasizes or alters its phenotype like changing up the types of neoantigens it expresses on the surface of the cancer cells. Because of this characteristic, Schatzman thinks the Boltbodies can even have the potential to prevent recurrence of cancer.

"We have demonstrated in some of our preclinical experiments that if a tumor loses that initial tumor antigen that we use to target the tumor with … the immune system still recognizes that tumor even without that initial antigen," said Schatzman.

Neoantigens expressed on tumor cells vary across patients. In the immune-oncology space, Schatzman noted that a number of companies are focusing on bolstering patients’ innate immunity by drawing T cells to attack the cancer.

"They’re targeting specific neo-antigens on the surface of tumors. They’re doing high-throughput sequencing, for example, and identifying these [neo-antigens] and then using those as tags to re-train the immune system," said Schatzman. Bolt’s approach with Boltbodies, he explained, would allow each patient to create an adoptive immunity to their own tumor and let the immune system choose which of these antigens it should recognize.

The important antigens, which if targeted can stop and kill tumors, can vary from person to person. "In this sense, rather than having to go through a complex personalization process that many companies are taking … we’re allowing the patient’s own immune system to determine what’s the best way to eliminate its own cancer," said Schatzman. "We think this is a technology that can apply to many types of tumor-targeting antibodies and also to a wide variety of tumor antigens."

He added that in the preclinical pipeline, Bolt is currently working on using its technology to improve upon the efficacies of checkpoint inhibitors. The firm will name a clinical candidate sometime later this year. Additionally, the biotech has an early program targeting an undisclosed tumor antigen that may have a role in difficult-to-treat cancers, such as colorectal cancer.

Meanwhile, BDC-1001 is entering human studies as the COVID-19 pandemic has made it challenging to bring vulnerable, immunocompromised cancer patients to study sites for enrollment, treatment administration, and follow-up data collection. A number of big pharmaceutical firms have made adjustments to their clinical trials operations during the public health crisis. For example, Bristol-Myers Squibb said that for ongoing studies, no new sites will be activated until April 13, and no news studies will launch until that date as well. Pfizer is similarly pausing enrollment in new and ongoing studies for three weeks, according to multiple reports.

Bolt is continuing to recruit patients into the sites it has activated for the Phase I trial. However, the firm has also implemented measures, such as integrating home care, to limit how often patients will have to come into study sites. "So far the sites that we have initiated to conduct this trial continue to recruit and continue to operate," Schatzman said. "We’re working with the [site managers and investigators] very closely to ensure the safety of our patients and yet allowing the healthcare center to do what it needs to do for other patients that require the other types of interventions" like for COVID-19

On March 30, 2020 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy based therapies, reported financial results for the fourth quarter and full year of 2019 and provided an update on strategic and operational developments (Press release, EDAP TMS, MAR 30, 2020, View Source [SID1234556047]).

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Marc Oczachowski, EDAP’s Chief Executive Officer, said: "We are proud of our team for a very successful year in 2019, which was our first full year of U.S. FDA approval for Focal One, our latest generation high Intensity Focused Ultrasound (HIFU) robotic device for the targeted ablation of prostate tissue. During the year, we placed Focal One devices at many highly regarded healthcare institutions, including Mayo Clinic, Houston Methodist Hospital, University of California at Irvine Medical Center and University of Chicago Medicine, among others. We ended the year with a strong sales pipeline and good momentum both in the U.S. and worldwide.

"As far as financial results, we grew our company sales by 14.5% year-over-year, which was driven by HIFU sales growth of 28%. We expanded our gross margins to a record 46.8%, which represents an increase of 362 basis points in 2019 as higher margin HIFU sales led to higher profitability. The Company has now been profitable for five consecutive quarters, and we have a strong balance sheet with EUR 20.9 million in cash. We are looking forward to the commencement of U.S. reimbursement for Focal One in 2021, which has the potential to be a significant catalyst for further adoption.

"The COVID-19 virus represents a major new challenge for all of us, and we are proactively taking measures across all areas of our business. Our number one priority is the health and safety of our employees and to ensure uninterrupted service to our existing customers. Due to this ongoing pandemic, we anticipate the likelihood of an impact to our near-term revenue as procedures are delayed and the sales cycle for new installations becomes elongated. However, we are pleased with the momentum with which we entered 2020, and we believe we have the resources to successfully navigate this crisis."

"Finally, we are announcing today that Philippe Chauveau is stepping down from his role as Chairman of the Board but will continue to serve as a Director until June of this year, as part of a long-established transition plan. Philippe’s insights have been invaluable since joining our Board in 1997," Mr. Oczachowski concluded.

EDAP’s Chief Executive Officer, Marc Oczachowski, has been selected by the Board to replace Mr. Chauveau as Chairman. Mr. Oczachowski has worked at EDAP in various roles of increasing responsibility since 1997, becoming Chief Operating Officer in November 2004 and Chief Executive Officer in March 2007. He has served as a Director on EDAP’s Board since 2017.

"I am humbled that my fellow directors have nominated me to assume the role of Chairman, and I remain steadfast in my commitment to maintain our position as a leading global innovator in the use of therapeutic ultrasound," Mr. Oczachowski commented.

Full Year 2019 Results

Total revenue for the full year of 2019 was EUR 44.9 million (USD 50.2 million), a 14.6% increase compared to EUR 39.2 million (USD 46.2 million) for the full year of 2018.

Total revenue in the HIFU business for the full year of 2019 was EUR 14.1 million (USD 15.8 million), a 28.1% increase compared to EUR 11.0 million (USD 13.0 million) for the full year of 2018.

For the full year of 2019, total revenue for the UDS division was EUR 30.8 million (USD 34.4 million), a 9.3% increase compared to EUR 28.1 million (USD 33.2 million) during the year-ago period.

Gross profit for the full year of 2019 was EUR 21.0 million (USD 23.5 million), compared to EUR 16.9 million (USD 19.9 million) for the year-ago period. Gross profit margin on net sales was 46.8% for the full year 2019 compared to 43.2% for the full year 2018.

Operating expenses were EUR 18.8 million (USD 21.0 million) for the full year of 2019, compared to EUR 18.2 million (USD 21.5 million) for the same period in 2018.

Operating profit for the full year of 2019 was EUR 2.2 million (USD 2.5 million), compared to an operating loss of EUR 1.3 million (USD 1.5 million) in the full year of 2018.

Net income for the full year of 2019 was EUR 1.5 million (USD 1.7 million), or earnings of EUR 0.05 per diluted share, as compared to a net loss of EUR 0.3 million (USD 0.4 million), or a loss of EUR 0.01 per diluted share in the year-ago period.

As of December 31, 2019, cash and cash equivalents were EUR 20.9 million (USD 23.4 million).

Fourth Quarter 2019 Results

Total revenue for the fourth quarter 2019 was EUR 12.0 million (USD 13.3 million), a 9.8% decrease compared to EUR 13.3 million (USD 15.1 million) for the fourth quarter of 2018.

Total revenue in the HIFU business for the fourth quarter 2019 was EUR 2.9 million (USD 3.2 million), a 33.1% decrease compared to EUR 4.3 million (USD 4.9 million) for the fourth quarter of 2018. The year-over-year decline was due to two Focal One units sold during the fourth quarter of 2019 compared to four Focal One units sold in the year ago period.

For the three months ended December 31, 2019, total revenue for the UDS division was EUR 9.1 million (USD 10.1 million), a 1.6% increase compared to EUR 8.9 million (USD 10.2 million) during the year-ago period.

Gross profit for the fourth quarter 2019 was EUR 5.1 million (USD 5.7 million), compared to EUR 6.0 million (USD 6.8 million) for the year-ago period. Gross profit margin on net sales was 43.0% in the fourth quarter of 2019, compared to 45.0% in the year-ago period. The decline in gross profit year-over-year was due to in part to lower sales in HIFU business as compared ot the year-ago period.

Operating expenses were EUR 5.1 million (USD 5.6 million) for the fourth quarter of 2019, compared to EUR 5.1 million (USD 5.8 million) for the same period in 2018.

Operating profit for the fourth quarter 2019 was EUR 0.1 million (USD 0.1 million), compared to EUR 0.8 million (USD 1.0 million) in the fourth quarter of 2018.

Net loss for the fourth quarter 2019 was EUR 1.0 million (USD 1.1 million), or EUR (0.03) per diluted share, as compared to net income of EUR 1.0 million (USD 1.2 million), or EUR 0.04 per diluted share in the year-ago period.

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT on Tuesday, March 31, 2020. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Tuesday, March 31, 2020 @ 8:30am Eastern Time
Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13700921
Webcast: View Source

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."