On September 3, 2020 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, reported its financial results and provided an operational update for the three months ended June 30, 2020 (Press release, BeyondSpring Pharmaceuticals, SEP 3, 2020, View Source [SID1234564408]).

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"BeyondSpring’s mission has been to develop innovative, transformative medicines that improve clinical outcomes in high unmet medical needs," said Dr. Lan Huang, Co-Founder, Chairman and Chief Executive Officer of BeyondSpring. "With our lead asset, first-in-class agent Plinabulin in late stage developments in two large oncology market opportunities, CIN and NSCLC, we believe that we are at a significant inflection point that will potentially result in helping many patients in need."

Dr. Huang continued, "We expect to file NDA for CIN, Plinabulin’s first indication, to the U.S. FDA by the end of the year. Plinabulin would potentially reduce infection and hospitalization after chemotherapy, and enable doctors to provide chemotherapy to their patients without compromise – this means stable doses, sustained cycles and the strongest regimens possible so that patients can stay the course with their treatment – for potential survival benefit. As a potent antigen presenting cell inducer, we believe that Plinabulin is a ‘pipeline in a drug’ for multiple cancer indications."

Select Second-Quarter 2020 and Recent Business Highlights

Recent Clinical Highlights

Plinabulin in CIN indication
Positive Superior Topline Pre-Specified Interim Results from PROTECTIVE-2 Phase 3

In June 2020, BeyondSpring reported positive topline results of the pre-specified interim analysis of its PROTECTIVE-2 Phase 3 trial, evaluating Plinabulin in combination with Neulasta, compared to Neulasta alone. The interim results showed that the combination significantly enhanced the efficacy of Neulasta in the "rate of Grade 4 neutropenia prevention" (p<0.01), the primary endpoint for the study, which is clinically meaningful. The enrollment of a total of 221 patients has been completed.

Expanded Access Program (EAP) Initiation

In August 2020, BeyondSpring initiated an EAP for Plinabulin in response to the recent NCCN guideline updates highlighting the need for maximum CIN prevention and resource allocation for COVID-19 patients. The program enables doctors across the U.S. to use Plinabulin, both alone and in combination with G-CSFs, to prevent CIN. The first patient dosed in the U.S. avoided Grade 4 neutropenia in Cycle 2 with the Plinabulin-Neulasta combination, despite experiencing Grade 4 neutropenia in Cycle 1 with Neulasta alone.

Plinabulin in NSCLC indication
DSMB Recommends DUBLIN-3 (Study 103) Phase 3 for NSCLC to Continue Without Modification

In June 2020, BeyondSpring reported that it reached the pre-specified second interim analysis for DUBLIN-3 for NSCLC treatment with Plinabulin. Upon reviewing the efficacy and safety data of over 500 patients at an approximately 300-patient death event, the DSMB advised BeyondSpring to continue the study without any modifications. DUBLIN-3 is a global Phase 3 trial for Plinabulin in combination with docetaxel, compared to docetaxel alone, for the treatment of second- / third-line EGFR wild-type NSCLC.

Triple I/O Combination Therapy with Plinabulin
New Preclinical Data Demonstrates Immune-Enhancing Effects

In June 2020, BeyondSpring presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting that the triple I/O combination of Plinabulin, anti-PD-1 and radiation demonstrated a 100 percent complete response in a PD-1 antibody model, indicating that Plinabulin enhances immuno-radiotherapy for cancer patients. The combination therapy is being advanced toward a Phase 1 clinical trial in patients who failed or progressed on PD-1 / PD-L1 antibody treatments. BeyondSpring expects the first patient dosing in H2 2020.

Recent Corporate Highlights

BeyondSpring Appoints Paul Friel to Chief Commercial Officer

In August 2020, BeyondSpring announced the appointment of Paul Friel to the role of Chief Commercial Officer. Mr. Friel has nearly 30 years of experience in the pharmaceutical and biotech industry. He has held positions as General Manager and President at Takeda Canada and Vice President of Sales for Vyaire. During his tenure with Takeda, Mr. Friel was instrumental in helping the organization expand its presence and grow to over 5,000 employees and $10 billion in sales.

Throughout Mr. Friel’s 24-years at TAP and Takeda, he served in multiple commercial roles and was responsible for business development, integration, geographic expansion and Head of Commercial for Latin America for Takeda. He later led Takeda expansions into Mexico, Brazil and Canada. In the last four years of Mr. Friel’s tenure at Takeda, he was integral for launching eight products, including the second fastest biologic launch in the U.S.

BeyondSpring Appoints Dr. Ravi Majeti to Board of Directors

During the same month, BeyondSpring also announced the appointment of Dr. Ravi Majeti, Co-Founder and former Board member of Forty Seven, Inc., and Chief, Division of Hematology, at Stanford University to the Company’s Board of Directors. Dr. Majeti co-founded Forty Seven in 2014 and was a major contributor to the research and technology that led to Forty Seven’s $4.9 billion acquisition by Gilead in March 2020.

Equity Financings

In June and July 2020, BeyondSpring closed a public offering of 2,219,500 ordinary shares and a private placement of 384,615 ordinary shares at $13.00 per share. Gross proceeds from the public offering and private placement were $33.9 million before deducting underwriting discounts, commissions and other offering expenses. The Company intends to use the net proceeds of the public offering and private placement to support the commercialization of Plinabulin, continued clinical and pre-clinical development and for general corporate purposes.

Financial Results for the Three Months Ended June 30, 2020

Research and development ("R&D") expenses were $11.0 million for the quarter ended June 30, 2020, compared to $5.2 million for the quarter ended June 30, 2019. The $5.8 million increase was largely attributable to an increase of $4.9 million in clinical trial expenses.

General and administrative ("G&A") expenses were $2.6 million for the quarter ended June 30, 2020, compared to $2.1 million for the quarter ended June 30, 2019. The $0.5 million increase was mainly due to an increase in cost related to pre-launch preparation of Plinabulin.

Net loss attributable to the Company was $12.8 million for the quarter ended June 30, 2020, compared to $7.4 million for the quarter ended June 30, 2019.

As of June 30, 2020, the Company had a cash and cash equivalents of $38.1 million. The Company believes it has sufficient cash to support its clinical trials and submit an NDA in the U.S. for Plinabulin for the CIN indication, as well as to advance its immuno-oncology pipeline and protein degradation research platform.

Anticipated Milestones

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

Final data readout for PROTECTIVE-2 Phase 3 for CIN – Q4 2020
NDA submission for Plinabulin for CIN in the U.S. – end of 2020
Final topline data readout for DUBLIN-3 for NSCLC – H1 2021
Rolling NDA submission for Plinabulin for NSCLC in China – H1 2021
NDA submission for Plinabulin for NSCLC in the U.S. – H2 2021
Conference Call and Webcast Information

BeyondSpring’s management will host a conference call and webcast today at 8 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: 13709037. 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 3, 2020 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported its participation in the following conferences (Press release, Lexicon Pharmaceuticals, SEP 3, 2020, View Source [SID1234564407]):

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Citi 15th Annual BioPharma Virtual Conference on Wednesday, September 9, 2020
Wells Fargo 2020 Virtual Healthcare Conference on Thursday, September 10, 2020
Jeffrey L. Wade, Lexicon’s executive vice president, corporate and administrative affairs and chief financial officer, will make a live webcast company presentation for the Wells Fargo conference on Thursday, September 10, 2020 at 2:00 p.m. ET. The webcast will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

On September 3, 2020 ImmuPharma plc (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, reported that L1 Capital Global Opportunities Master Fund ("L1") has converted $150,000 (plus accrued but unpaid interest) of the convertible security issued pursuant to the convertible security deed dated 10 June 2020, details of which were announced by the Company on 11 June 2020 (Press release, ImmuPharma, SEP 3, 2020, View Source [SID1234564406]). The conversion price is 11p per share resulting in the issue by the Company of 1,045,046 new ordinary shares of 10p each in the Company ("New Ordinary Shares").

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New Ordinary Shares and Admission

The New Ordinary Shares will be issued credited as fully paid and will rank pari passu in all respects with the Company’s existing issued ordinary shares.

An application will be made for the New ordinary Shares to be admitted to trading on the AIM market of the London Stock Exchange ("AIM") and Euronext Growth Brussels ("Admission"). It is anticipated that Admission to AIM will occur at 8.00am on or around 8 September 2020.

The New Ordinary Shares represent 0.43% of the Company’s enlarged issued share capital.

Total Shares in Issue

For the purposes of the Disclosure Guidance and Transparency Rules of the Financial Conduct Authority ("DTR"), the Board of ImmuPharma hereby notifies the market that following Admission, the Company’s total issued share capital will consist of 243,829,117 Ordinary Shares with a nominal value of 10p each.

This figure may be used by Shareholders as the denominator for the calculations by which they may determine if they are required to notify their interest in, or a change to their interest in, the Company under the DTR.

The allotment of the New Ordinary Shares is being made pursuant to existing authorities to allot shares and other relevant securities and to disapply pre-emption rights under section 551 of the Companies Act 2006, which the Directors were given at the Company’s Annual General Meeting held on 18 June 2020.

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 ("MAR"). In addition, market soundings (as defined in MAR) were taken in respect of the Subscription with the result that certain persons became aware of inside information (as defined in MAR), as permitted by MAR. This inside information is set out in this Announcement. Therefore, those persons that received inside information in a market sounding are no longer in possession of such inside information relating to the Company and its securities.

On August 31, 2020, Selecta Biosciences, Inc. (the "Company") reported that it entered into a term loan facility of up to $35.0 million (the "Term Loan"), consisting of term loans in an aggregate amount of $25.0 million (the "Term A Loan") and term loans in an aggregate amount of $10.0 million (the "Term B Loan"), with Oxford Finance LLC, a Delaware limited liability company ("Oxford"), as collateral agent (in such capacity, "Collateral Agent"), and the lenders party thereto (the "Lenders"), including Oxford in its capacity as a lender and Silicon Valley Bank, a California corporation ("SVB"), the proceeds of which will be used to repay the Company’s existing term loan facility and for general corporate and working capital purposes (Filing, 8-K, Selecta Biosciences, AUG 31, 2020, View Source [SID1234564405]).

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The Term Loan is governed by a loan and security agreement, dated August 31, 2020, between the Company, Collateral Agent and the Lenders (the "Loan Agreement"). The Term A Loan was funded in full on August 31, 2020 (the "Funding Date"). The Term B Loan will be available, subject to Collateral Agent’s discretion and customary terms and conditions, during the period commencing on the date the Company has delivered to the Collateral Agent and the Lenders evidence that (i) the Company or one of the Company’s collaboration partners has enrolled its first randomized patient for a Phase 1 clinical trial evaluating SEL-302, and (ii) the Company has enrolled the first patient in each of two Phase 3 pivotal trials evaluating SEL-212 (the "Second Draw Period Milestone") and ending on the earliest of (i) the date which is thirty (30) days following the date the Second Draw Period Milestone is achieved, (ii) September 30, 2021 and (iii) the occurrence of an event of default, other than an event of default that has been waived in writing by Collateral Agent and the Lenders in their sole discretion (such period, the "Second Draw Period").

The Term Loan will mature on August 1, 2025. Each advance under the Term Loan accrues interest at a floating per annum rate equal to the greater of (a) seven and nine tenths of one percent (7.90%), and (b) the lesser of (x) the sum of (i) the prime rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, and (ii) four and sixty-five hundredths of one percent (4.65%) and (y) ten percent (10.00%). The Term Loan provides for interest-only payments on a monthly basis until April 1,2022; provided however, if the Company has delivered to Collateral Agent and the Lenders prior to September 30, 2021 evidence that Borrower has achieved the Second Draw Period Milestone, the Term Loan provides for interest-only payments on a monthly basis until October 1, 2022. Thereafter, amortization payments will be payable monthly in equal installments of principal and interest to fully amortize the outstanding principal over the remaining term of the loan, subject to recalculation upon a change in the prime rate. The Company may prepay the Term Loan in full but not in part provided that the Company (i) provides ten days’ prior written notice to Collateral Agent, (ii) pays on the date of such prepayment (A) all outstanding principal plus accrued and unpaid interest, and (B) a prepayment fee of between 3.0% and 1.0% of the aggregate original principal amount advanced by the lender depending on the timing of the prepayment. Amounts outstanding during an event of default are payable upon SVB’s demand and shall accrue interest at an additional rate of 5.0% per annum of the past due amount outstanding. At the end of the loan term (whether at maturity, by prepayment in full or otherwise), the Company shall make a final payment to the lender in the amount of 9.0% of the aggregate original principal amount advanced by the lender.

The Term Loan is secured by a lien on substantially all of the assets of the Company, other than intellectual property, provided that such lien on substantially all assets includes any rights to payments and proceeds from the sale, licensing or disposition of intellectual property. The Company has also granted Collateral Agent a negative pledge with respect to its intellectual property.

The Loan Agreement contains customary covenants and representations, including but not limited to financial reporting obligations and limitations on dividends, indebtedness, collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, deposit accounts, and subsidiaries. The Loan Agreement also contains other customary provisions, such as expense reimbursement, non-disclosure obligations as well as indemnification rights for the benefit of Collateral Agent.

The events of default under the Loan Agreement include, but are not limited to, the Company’s failure to make any payments of principal or interest under the Loan Agreement or other transaction documents, the Company’s breach or default in the performance of any covenant under the Loan Agreement or other transaction documents, the occurrence of a material adverse change, the Company making a false or misleading representation or warranty in any material respect under the Loan Agreement, the Company’s insolvency or bankruptcy, any attachment or judgment on the Company’s assets of at least $500,000, or the occurrence of any default under any agreement or obligation of the Company involving indebtedness in excess of $500,000. If an event of default occurs, Collateral Agent is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement.

On August 31, 2020, in connection with the Loan Agreement, the Company issued warrants to the Lenders (collectively, the "Warrants") to purchase an aggregate of 203,850 shares (the "Warrant Shares") of the Company’s common stock, par value $0.0001 per share ("Common Stock"), at an exercise price equal to $2.54 per share, subject to customary adjustments for stock

On September 3, 2020 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported that members of the management team will participate in the following upcoming investor conferences and will provide a corporate update (Press release, Pieris Pharmaceuticals, SEP 3, 2020, View Source [SID1234564404]):

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Baird 2020 Virtual Global Healthcare Conference

Wednesday, September 9, 2019 at 11:25AM EDT

H.C. Wainwright 22nd Annual Global Investment Conference

Wednesday, September 16, 2019 at 2:00PM EDT

Additional information regarding these events will be available on the Company’s website at www.pieris.com.