On September 18, 2019 PTC Therapeutics, Inc. (Nasdaq: PTCT) reported that it has priced its private offering of $250.0 million aggregate principal amount of its convertible senior notes due 2026 (the "Notes") (Press release, PTC Therapeutics, SEP 18, 2019, View Source [SID1234539632]). The Notes will be sold only to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). PTC has granted to the initial purchaser a 30-day option to purchase up to an additional $37.5 million aggregate principal amount of the Notes.

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The Notes will be senior unsecured obligations of PTC and will mature on September 15, 2026, unless earlier converted, redeemed or repurchased in accordance with their terms prior to such date. The Notes will bear interest at a rate of 1.50% per year, payable semi-annually. The Notes will be convertible prior to March 15, 2026, only upon the occurrence of certain circumstances and will be convertible on or after such date regardless of these circumstances, in either case, into cash, shares of PTC’s common stock or any combination thereof at PTC’s election. The conversion rate for the Notes will initially be 19.0404 shares of common stock per $1,000 principal amount, which is equivalent to an initial conversion price of approximately $52.52 per share of common stock. The initial conversion price of the Notes represents a premium of approximately 30% above the public offering price of the previously announced concurrent public offering of common stock by PTC (the "Concurrent Common Stock Offering").

PTC may not redeem the Notes prior to September 20, 2023. PTC may redeem for cash all ‎or any portion of the Notes, at its option, on or after September 20, 2023 if the last reported sale ‎price of PTC’s common stock has been at least 130% of the conversion price then in effect on the last trading day of, and for at ‎least 19 other trading days (whether or not consecutive) during, any 30 consecutive trading day period ‎‎ending on, and including, the trading day ‎immediately preceding the date on which PTC provides notice of redemption, at a redemption price ‎equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid ‎interest to, but excluding, the redemption date.

The sale of the Notes is expected to close on September 20, 2019, subject to the satisfaction of customary closing conditions. The offering of the Notes is not contingent upon the consummation of the Concurrent Common Stock Offering, and the Concurrent Common Stock Offering is not contingent upon the consummation of the offering of the Notes.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction. Any offers of the Notes will be made only by means of a confidential offering memorandum. The Notes and the shares of PTC’s common stock underlying these securities have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States without registration or an applicable exemption from registration requirements.

On September 18, 2019 Johnson & Johnson (NYSE: JNJ) reported that it will host a conference call for investors at 8:30 a.m. (Eastern Time) on Tuesday, October 15th to review third-quarter results (Press release, Johnson & Johnson, SEP 18, 2019, View Source;johnson-to-host-investor-conference-call-on-third-quarter-results-300921132.html [SID1234539630]). Joseph J. Wolk, Executive Vice President, Chief Financial Officer and Christopher DelOrefice, Vice President, Investor Relations will host the call. The question and answer portion of the call will also include the following executives: Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices; Thibaut Mongon, Executive Vice President, Worldwide Chairman, Consumer; and Jennifer Taubert, Executive Vice President, Worldwide Chairman, Pharmaceuticals.

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Investors and other interested parties can access the webcast/conference call in the following ways:

The webcast and presentation material are accessible at Johnson & Johnson’s website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes.
By telephone: for both "listen-only" participants and those financial analysts who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 877-869-3847. For participants outside the U.S., the dial-in number is 201-689-8261.
A replay of the conference call will be available until approximately 12:00 a.m. on October 23, 2019. The replay dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. The replay conference ID number for all callers is 13694535.
The press release will be available at approximately 6:45 a.m. (Eastern Time) the morning of the conference call.

On September 18, 2019 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI or the Company), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that it has commenced an underwritten public offering of its common shares (Press release, VBI Vaccines, SEP 18, 2019, View Source [SID1234539629]). VBI also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of common shares offered in the public offering. 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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Raymond James & Associates, Inc. and Oppenheimer & Co. Inc. are acting as joint book-running managers, and National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (NASDAQ:NHLD), is acting as lead manager for the underwritten public offering.

VBI intends to use the net proceeds from the offering to progress its pipeline programs including the completion of the global CONSTANT Phase 3 lot-to-lot consistency study, regulatory submissions, and pre-commercialization activities for Sci-B-Vac, a trivalent hepatitis B vaccine, and for the continued clinical development of VBI-1901, a vaccine immunotherapeutic candidate for recurrent glioblastoma (GBM); VBI-2601, an immunotherapeutic candidate for chronic hepatitis B infection; and VBI-1501, a cytomegalovirus (CMV) vaccine candidate. The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement relating to the common shares was previously filed with the Securities and Exchange Commission (SEC) and declared effective on July 30, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement (when available) and accompanying prospectus may be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, by e-mail at [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004 or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the 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 registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement

On September 18, 2019 NANOBIOTIX (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’), reported encouraging findings from the Company’s phase I study evaluating first-in-class radioenhancer NBTXR3 activated by stereotactic body radiation (SBRT) (Press release, Nanobiotix, SEP 18, 2019, View Source [SID1234539628]). These data were presented at the ASTRO 2019 Annual Meeting by investigator Dr. Enrique Chajon.

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Hafnium oxide nanoparticles activated by SBRT for the treatment of hepatocellular carcinoma and liver metastasis: a phase I/II trial

Enrique Chajon1, Marc Pracht1, Yann Rolland1, Thierry de Baere2, France Nguyen2, Jérôme Durand-Labrunie2, Jean-Pierre Bronowicki3, Véronique Vendrely4, Antonio Sa Cunha5, Anne-Sophie Baumann6, Valérie Croisé-Laurent3, Emanuel Rio7, Samuel Le Sourd1, Pierre Gustin2, Patricia Said8, Christophe Perret7, Didier Peiffert5, Eric Deutsch2

1Radiation Oncology, Centre Eugene – Marquis, Rennes, FR, 2Radiation oncology, Institut Gustave Roussy, Villejuif, FR, 3Hepatology and Gastroenterology, Hôpital de Brabois, Vandoeuvre Les Nancy, FR, 4Radiotherapy, Groupe Hospitalier Sud – Hôpital Haut-Lévêque, Pessac, FR, 5Centre Hépato-Biliaire Paul Brousse, Villejuif, FR, 6Radiotherapy, Institut de Cancérologie de Lorraine, Nancy, FR, 7Radiotherapy, Institut de cancérologie de l’Ouest, Nantes, FR, 8Nanobiotix, SA, Paris, Fr

The population for this study included (i) hepatocellular carcinoma (HCC) patients with a minimum life expectancy of three (3) months that were unsuitable for local surgery or local treatment and (ii) liver metastasis (mets) patients with a minimum life expectancy of six (6) months whose tumors are unresectable. The total number of HCC patients was 11, the total numbers of mets patients was 6.

The HCC patient population has high unmet medical needs as they have underlying liver dysfunction and concomitant malignancies that limit treatment options. Stereotactic body radiation therapy (SBRT) is a well-tolerated alternative therapy, however the dose is limited by hepatic function which is widely impaired in this group. Therefore, these patients need a way to increase the dose delivered to the tumor while sparing surrounding healthy tissues without additional strain on the liver. Moreover, given the short life expectancy of these patients, the need is particularly urgent.

Given that NBTXR3 is inert unless exposed to radiotherapy, is not metabolized by the liver, and can be administered regardless of liver and renal function, the first-in-class treatment offers an opportunity to increase

the efficacy of SBRT while maintaining tolerable dose levels for the patient. In this study, the safety profile of NBTXR3 activated by SBRT was similar to SBRT alone with no dose-limiting toxicity (DLT). Additionally, NBTXR3 also proved to remain within the injected tumor with no leakage to surrounding tissue.

To date, 62.5% of evaluable HCC patients have shown a complete response while the rest have shown partial response. These results show that NBTXR3 activated by SBRT may present as a valuable option in patients with HCC not amenable to curative local treatment or with unresectable liver metastases.

In liver mets, 50% of patients have shown partial response and 50% show stable disease.

Given that the safety profile was very good and there were no DLTs, the protocol was amended to include a fifth dose escalation level of 42%. Three (3) patients have already been recruited and recruitment is expected to be complete in Q4. Results for all patients are expected in Q1 2020.

These results are significant for the Company as they increase the scope of patients NBTXR3 may treat beyond Soft Tissue Sarcoma and Head and Neck cancer. The Company remains focused on its head and neck plan but will now accelerate integration of HCC into its go-to-market strategy.

***

About NBTXR3

NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.

NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity oropharynx in elderly and frail patients unable to receive chemotherapy or cetuximab with very limited therapeutic options. Promising results have been observed in the phase I/II trial regarding the local control of the tumors. In the United States, based on the discussions with the Food and Drug Administration that occurred in the first half of 2019, the Company plans to begin the clinical trial authorization process in the second half of 2019 and commence a phase II/III clinical trial in locally advanced head and neck cancers.

Nanobiotix is also running an Immuno-Oncology development program. In the United States, the Company received approval from the Food and Drug Administration to launch a clinical trial of NBTXR3 activated by radiotherapy in combination with antiPD-1 antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer).

The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma. Further, the company has a large-scale, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center (9 new phase I/II clinical trials in the United States) to evaluate NBTXR3 across head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.

On September 18, 2019 OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS), reported the appointment of Robert Petit, Ph.D., as its Chief Medical and Scientific Advisor. He is continuing to support the technology that he helped to develop at Advaxis (Press release, OS Therapies, SEP 18, 2019, View Source [SID1234539627]).

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Dr. Petit is a highly successful C-level executive and biopharma leader with a diverse background in research and development with over 25 years of experience in clinical development, and pre-clinical and translational research. In addition, he has helped to build, grow and secure investments for respected academic organizations, as well as private and publicly traded biopharma companies. An accomplished immuno-oncology scientist, innovator and drug developer, he has been integral to 7 NDA/BLA/EMA filings in the immuno-oncology space and was part of team at BMS who established the first checkpoint inhibitor therapy. Most recently, Dr. Petit served as Chief Scientific Officer of Advaxis, Inc., contributing to their successful NASDAQ IPO, raising significant capital, and evolving their platform technology to leverage both personal and shared neoantigens.

"I am excited to join the OS Therapies team and contribute toward realizing the potential of the OS Therapies lead program in the treatment of osteosarcoma," said Dr. Petit. "I also look forward to furthering the mission of OS Therapies by assisting in building a pipeline of assets that will improve treatment options and outcomes for patients with osteosarcoma."

"From our first meeting with Advaxis to discuss out-licensing for the Osteosarcoma indication, we knew Robert was the driving force behind the development of the technology," said Paul Romness, Chief Executive Officer of OS Therapies. "Already, he has been a crucial contributor to our team in bringing knowledge and passion for the technology. As our Chief Medical and Scientific Advisor, he is set to bring even more confidence and institutional knowledge to our investors and clinical researchers alike."