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 STORM Therapeutics, the biotechnology company focused on the discovery of small molecule therapies modulating RNA epigenetics reported that Oliver Rausch, Chief Scientific Officer of STORM Therapeutics will present first of its kind data on targeting RNA modifying enzymes for cancer treatment at its inaugural "RNA Epigenetics in Human Disease Conference" taking place at St Catharine’s College, Cambridge, UK on 17-20 September 2019 (Press release, STORM Therapeutics, SEP 18, 2019, View Source [SID1234561039]). Attendees are from renowned academic research institutions and pharmaceutical and biotechnology companies worldwide.

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The presentation will take place at 12:00 BST today, Wednesday 18th September and is entitled "Targeting RNA modifying enzymes for the treatment of cancer".

Oliver Rausch will present research encapsulating STORM’s ground-breaking work on targeting RNA modifying enzymes for cancer treatment. He will describe how it employs leading analytical and drug discovery capabilities to establish a comprehensive pharmacological audit trail linking therapeutic efficacy to METTL3 target and pathway inhibition. STORM has identified small molecule inhibitors of METTL3 that are orally bioavailable and show pronounced anti-tumour efficacy in physiologically relevant, proof of concept animal models of Acute Myeloid Leukaemia (AML). The talk will demonstrate that small molecule inhibition of METTL3 produces the same phenotype and effects previously described in one of STORM’s founder scientists publications using genetic models and validates METTL3 as a druggable target for cancer.

Keith Blundy, CEO of STORM Therapeutics, said: "STORM is the first Company in the world to demonstrate in vivo activity of an RNA methyltransferase inhibitor, showing proof of concept efficacy in animal models and is on course to enter the clinic in 2021. STORM is exploring the potential of its first-in-class inhibitors in various solid and haematological cancers and other therapeutic areas. We are excited to be leading the field as we look to develop these highly innovative new treatment options for cancer patients."

Tony Kouzarides, Founder of STORM Therapeutics, added: "We founded STORM Therapeutics to lead and accelerate development of drugs targeting RNA epigenetics. We are proud to be the first company making significant progress towards this aim, with multiple programmes in in vivo testing currently."

For more information on the RNA Epigenetics in Human Disease Conference and the programme please visit: https://stormtxconference2019.com/

On September 18, 2019 BeyondSpring Inc. ("BeyondSpring" or the "Company") (NASDAQ:BYSI), a global biopharmaceutical company focused on developing transforming immuno-oncology cancer therapies, reported its financial results for the three months ended June 30, 2019, and provided an update on its operations (Press release, BeyondSpring Pharmaceuticals, SEP 18, 2019, View Source [SID1234539609]).

"During the second quarter, we continued to demonstrate Plinabulin’s favorable drug profile for the treatment of NSCLC and CIN," said Lan Huang, Ph.D., Chairman, Chief Executive Officer and Co-Founder of BeyondSpring. "In addition to results from our CIN studies, which provided strong rationale for the use of Plinabulin alone and in combination with G-CSF for the prevention of intermediate-risk and high-risk CIN, the Data Safety Monitoring Board advised Study 103 to continue after the first interim analysis."

"In the near term, we expect to continue to generate additional data for Plinabulin in both NSCLC and CIN indications to support NDA filings in China followed by the U.S. Our recent financing activities position us well to achieve these key milestones," added Dr. Huang.

Select Second-Quarter 2019 and Recent Highlights

NSCLC

Study 103

In September 2019, BeyondSpring announced that a poster describing the Company’s novel design for Study 103, titled "DUBLIN-3, a Phase (Ph) III Trial Comparing the Plinabulin (P) / Docetaxel (D) Combination with D Alone in Stage IIIB / IV NSCLC," was presented at the International Association for the Study of Lung Cancer World Conference on Lung Cancer in Barcelona, Spain.

CIN

Study 105 (Intermediate-Risk Chemotherapy)

In August 2019, BeyondSpring announced that an abstract, titled "Quality of Life (QoL) in Advanced NSCLC Patients Treated with Docetaxel and with Either Plinabulin or Pegfilgrastim for the Prevention of Neutropenia," was accepted for presentation at the September 8, 2019 IASLC World Conference on Lung Cancer. The abstract demonstrates that, compared to Neulasta, Plinabulin at 20mg/m2 significantly improves QoL over four treatment cycles. Plinabulin also significantly improved fatigue, pain and insomnia.

At the International Society for Pharmacoeconomics and Outcomes Research 2019 Conference in May 2019, Dr. Douglas Blayney, global Principal Investigator for BeyondSpring’s CIN development program and Professor of Medicine at Stanford University Medical Center, presented data derived from the Phase 2 portion of Study 105 demonstrating that Plinabulin at 20mg/m2 has a similar efficacy profile in reducing docetaxel-induced neutropenia as Neulasta 6mg, while avoiding the patient-reported bone pain typically observed with Neulasta.

Study 106 (High-Risk Chemotherapy)

In June 2019, BeyondSpring announced that two abstracts were accepted for publication in the Proceedings of the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting. The data, derived from the Phase 2 portion of Study 106, provided a strong rationale for the Plinabulin-G-CSF combination for the prevention of CIN for improved CIN control. Additionally, the Plinabulin-G-CSF combination nearly eliminated patients’ treatment-related bone pain.

1
BeyondSpring is currently initiating the Phase 3 portion of Study 106.

Mechanism of Action

In April 2019, BeyondSpring presented novel data relevant to predictive biomarkers for patient selection for Plinabulin at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. At the same conference, BeyondSpring presented preclinical data demonstrating Plinabulin’s ability to reduce tumor associated M2 macrophages, which are thought to support tumor cell survival and metastasis, as well as shift the phenotypic balance to one favoring M1 macrophages, which are thought to have anti-cancer properties.

Equity Financings

On July 19, 2019, BeyondSpring closed a public offering, led by Decheng Capital, of 2,058,825 ordinary shares at a public offering price of $17.00 per share. Gross proceeds from the public offering were $35.0 million, before deducting underwriting discounts and commissions and other offering expenses. The Company intends to use the net proceeds of this offering to support continued clinical and pre-clinical development and for general corporate purposes.

In June and July 2019, BeyondSpring’s partially owned Chinese subsidiary, Dalian Wanchunbulin Pharmaceuticals Ltd. ("Wanchunbulin") entered into definitive agreements for the sale of its equity interests ("Equity Purchase Agreements") to certain investors led by Efung Capital. Under the Equity Purchase Agreements, Wanchunbulin expects to sell 4.76% of the equity of Wanchunbulin for aggregate cash consideration of RMB 100 million, or approximately $14.5 million, before deducting offering expenses, to finance clinical and pre-clinical development and for general corporate purposes. To date, the Company has received RMB 70 million, or approximately $10.1 million, from this equity financing.

In May 2019, BeyondSpring entered into an Open Market Sale AgreementSM with Jefferies LLC to sell ordinary shares of the Company, with aggregate gross proceeds of up to $30.0 million, from time to time, through an at-the-market ("ATM") facility. In July 2019, this facility was suspended in anticipation of the public offering completed on July 19, 2019. As at the ATM’s suspension date, the Company had received aggregate gross proceeds of $13.0 million on 620,753 ordinary shares already sold through this facility.

Financial Results for the Three Months Ended June 30, 2019

Research and development ("R&D") expenses were $5.2 million for the quarter ended June 30, 2019, compared to $11.0 million for the quarter ended June 30, 2018. The $5.8 million decrease in R&D expenses was largely attributable to a $3.9 million decrease in expense incurred by clinical research organizations and other service fee related to clinical trials, a $1.1 million decrease in manufacturing expenses and a $0.8 million decrease in non-cash share-based compensation.

General and administrative ("G&A") expenses were $2.1 million for the quarter ended June 30, 2019, compared to $1.4 million for the quarter ended June 30, 2018. The $0.7 million increase in G&A expenses was mainly due to non-cash share-based compensation.

Net loss attributable to the Company was $7.4 million for the quarter ended June 30, 2019, compared to $12.2 million for the quarter ended June 30, 2018.

As of June 30, 2019, the Company had a cash balance of $0.7 million. With the net proceeds received from the recent equity financing activities described above, the Company believes it has sufficient cash to support its clinical trials and submit NDAs in China for Plinabulin for the treatment of CIN and NSCLC, and to advance its immuno-oncology pipeline and its ubiquitination protein degradation research platform.

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Anticipated Milestones

The following outlines the Company’s key anticipated upcoming milestones and projected timelines.

Second interim analysis for Study 103 Phase 3 for NSCLC – Q4 2019 / Q1 2020

Final data readout for Study 105 Phase 3 for CIN – Q1 2020

Top line data readout for Study 106 Phase 3 for CIN – Q1 2020

Submit NDAs to China’s National Medical Products Administration for Plinabulin for NSCLC and CIN – Q1 2020

Submit NDAs to the FDA for Plinabulin for NSCLC and CIN – 2020

Conference Call and Webcast Information

BeyondSpring’s management will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss the financial results and provide a corporate update. The dial-in numbers for the conference call are 1-877-451-6152 (U.S.) or 1-201-389-0879 (international). Please reference conference ID 13694411. A live webcast will be available on BeyondSpring’s website at www.beyondspringpharma.com under "Events & Presentations" in the Investors section. An archived replay of the webcast will be available for 30 days.

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 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.