On June 16, 2021 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, reported its financial results for the first quarter ended March 31, 2021 and provided an update on recent corporate events(Press release, BeyondSpring Pharmaceuticals, JUN 16, 2021, View Source [SID1234584056]).

"This quarter was marked by meaningful progress on the road toward building our lead first-in-class asset, plinabulin, as a pipeline in a drug, from treating chemotherapy side effects to treating cancer directly," said Dr. Lan Huang, co-founder, chairwoman and chief executive officer of BeyondSpring. "We are grateful that our NDA for chemotherapy-induced neutropenia (CIN) prevention was filed by the U.S. FDA with priority review. Our plinabulin and G-CSF combination has the potential to elevate the standard of care in CIN for the first time in 30 years. In addition, in the coming months, we plan to announce topline anti-cancer overall survival data from the Phase 3 DUBLIN-3 trial in NSCLC. We are building clinical evidence to demonstrate that plinabulin is a potent antigen presenting cell (APC) inducer with potential to be a ‘game changer’ in cancer treatment for severely unmet medical needs."

Recent Corporate Highlights

Lead Asset Plinabulin, a "Pipeline in a Drug"

Clinical Update

June 2021: Announced Food and Drug Administration (FDA) filing of New Drug Application with Priority Review for plinabulin and G-CSF combination for the prevention of CIN. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date for November 30, 2021.

June 2021: Presented three poster presentations at the 2021 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) highlighting the Company’s PROTECTIVE-2 Phase 3 data demonstrating combination plinabulin + pegfilgrastim offers superior benefit in reducing the incidence and severity of febrile neutropenia (FN) and hospitalization, with better quality-of-life (QoL), compared to pegfilgrastim alone.

June 2021: Announced late-breaking poster presentation at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting highlighting data from Phase 3 PROTECTIVE-2 CIN Study showing plinabulin in combination with pegfilgrastim improves CIN prevention and reverses key aspects of the immune suppressive profile of monotherapy pegfilgrastim.

June 2021: Presented data at ASCO (Free ASCO Whitepaper) 2021 of plinabulin in combination with nivolumab and ipilimumab, showing a 46% objective response rate (ORR) in 13 evaluable patients with PD-1/PD-L1 naïve or resistant tumors in 2nd line and beyond in small cell lung cancer (SCLC). Additionally, data demonstrated the plinabulin combination was able to re-sensitize tumors to I/O therapy, that had progressed on prior PD-1/PD-L1 inhibitors, with a 43% ORR.

June 2021: Dosed first patient in a triple combination study with plinabulin, PD-1/PD-L1 inhibitor and radiotherapy at MD Anderson for the reversal of resistance to PD-1/PD-L1 inhibitors in patients with seven advanced solid tumors.

Upcoming Clinical Milestones

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Mid-2021 (DUBLIN-3): Topline overall survival (OS) data expected in pivotal Phase 3 non-small cell lung cancer (NSCLC) study.

2022: (Big Ten Cancer Research Consortium, Investigator Initiated study): Phase 2 Data expected in plinabulin + nivolumab + ipilimumab in checkpoint inhibitor-resistant SCLC.

2022: (MD Anderson investigator led study): Phase 1 Data expected in plinabulin + PD-1/PD-L1 inhibitors + radiation in PD-1/PD-L1-failed patients in seven cancers, including bladder cancer, melanoma, Merkel cell cancer, MSI-H Cancers (of any histology), NSCLC, renal cell cancer, and SCLC.

First Quarter 2021 Financial Results

Research and development ("R&D") expenses were $11.3 million for the quarter ended March 31, 2021, compared to $13.7 million for the quarter ended March 31, 2020. The decrease of $2.4 million was primarily due to a decrease in clinical trial expenses and non-cash stock-based compensation expense, partially offset by an increase in manufacturing costs and the cost of the plinabulin regulatory filings.

General and administrative ("G&A") expenses were $6.4 million for the quarter ended March 31, 2021, compared to $2.9 million for the quarter ended March 31, 2020. The $3.5 million increase was primarily due to higher personnel costs, non-cash stock-based compensation expense, as well as costs associated with plinabulin pre-commercialization activities.

Net loss attributable to the Company was $17.0 million for the quarter ended March 31, 2021, compared to $16.1 million for the quarter ended March 31, 2020.

As of March 31, 2021, the Company had cash and cash equivalents of $90.6 million on hand. The Company believes it has sufficient cash to support its ongoing clinical programs over the next year, including its immuno-oncology pipeline, and to prepare for a potential launch of plinabulin in CIN in early 2022.

First Quarter 2021 Results Conference Call and Webcast Details
The management of BeyondSpring will host a conference call and webcast for the investment community today, June 16, 2021, at 8:30 am ET. The conference call can be accessed by dialing 855-327-6837 (U.S. and Canada) or +1-631-891-4304 (International). The passcode for the conference call is 10014535 To access the live webcast or subsequent archived recording, click here or visit the "investors" section of the BeyondSpring website at www.beyondspringpharma.com. The webcast will be recorded and available for replay on the company’s website for 90 days.

Molecular Partners AG, a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported the pricing of its initial public offering in the United States of 3,000,000 American Depositary Shares ("ADSs") at a public offering price of $21.25 per ADS, for total gross proceeds of approximately $63.8 million (Press release, Molecular Partners, JUN 16, 2021, View Source [SID1234584054]). All ADSs sold in the offering were offered by Molecular Partners. Each ADS will represent one Molecular Partners ordinary share. The new ordinary shares underlying the ADSs will be issued from Molecular Partners’ authorized capital under exclusion of the existing shareholders’ pre-emptive rights. In addition, Molecular Partners has granted the underwriters a 30-day option to purchase up to an additional 450,000 ADSs at the initial public offering price, less underwriting discounts and commissions.

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Trading of the ADSs is expected to commence on The Nasdaq Global Select Market on Wednesday, June 16, 2021 under the ticker symbol "MOLN." SIX Swiss Exchange ("SIX") approved the listing of the new ordinary shares underlying the ADSs as of June 17, 2021.

On June 16, 2021, trading of the existing shares of Molecular Partners on SIX will be halted. If trading of the ADS on the Nasdaq will commence at 4 p.m. CEST on June 16, 2021 or any time before, trading of the shares of Molecular Partners on SIX will reopen on the same day. If trading on the Nasdaq starts later, trading of the shares in Molecular Partners on SIX will reopen on June 17, 2021 only.

The offering is expected to close on or about June 18, 2021, subject to customary closing conditions.

J.P. Morgan, SVB Leerink and Cowen are acting as joint book-running managers for the proposed offering. RBC Capital Markets is acting as the bookrunner for the proposed offering. Kempen & Co is acting as the lead manager for the proposed offering.

A registration statement on Form F-1 relating to these securities became effective on June 15, 2021. The securities referred to in this release are to be offered only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, a written copy may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6105, or by e-mailing [email protected]; Cowen and Company, LLC (c/o Broadridge Financial Services), 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected]. The securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. In connection with the listing of the ordinary shares on the SIX, the registration statement on Form F-1 constitutes a foreign prospectus within the meaning of article 54 paras. 2 and 3 of the Swiss Financial Services Act of June 15, 2018 ("FinSA") and article 70 paras. 2-4 of the Swiss Financial Services Ordinance of November 6, 2019 ("FinSO"). The registration statement on Form F-1, including the preliminary prospectus, as well as the final prospectus, once available, will be deposited with the Prospectus Office of SIX Exchange Regulation. Further, the inclusion of the foreign prospectus in the prospectus list published by the Prospectus Office of SIX Exchange Regulation will be requested.

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 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 jurisdiction. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of Molecular Partners in or into Switzerland within the meaning of FinSA.

On June 16, 2021, Anixa Biosciences, Inc. (the "Company") delivered notice to B. Riley FBR, Inc. (the "B. Riley FBR") terminating the At-the-Market Issuance Sales Agreement, dated June 21, 2019 (the "Agreement"), with B. Riley FBR effective as of June 21, 2021(Press release, Anixa Biosciences, JUN 16, 2021, View Source [SID1234584052]). The Agreement provided for the Company to offer and sell shares of the Company’s common stock from time to time in an at-the-market equity program through B. Riley FBR, as sales agent.

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On June 16, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) ("MorphoSys") reported that it is commencing a cash tender offer to purchase all outstanding shares of Constellation Pharmaceuticals, Inc., (NASDAQ: CNST) ("Constellation") for $34.00 per share, net to the seller in cash, without interest, and subject to any applicable withholding of taxes (Press release, MorphoSys, JUN 16, 2021, View Source [SID1234584053]). The tender offer is being made pursuant to the previously announced merger agreement, dated June 2, 2021 between MorphoSys and Constellation.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The tender offer is scheduled to expire at one minute past 11:59 p.m. New York City Time, on July 14, 2021, unless extended or earlier terminated, in each case in accordance with the terms of the merger agreement. The tender offer is subject to various conditions including a minimum tender of at least a majority of outstanding Constellation shares, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and other customary conditions. The transaction is expected to close in the third quarter of 2021, as previously announced.

MorphoSys filed today with the U.S. Securities and Exchange Commission (the "Commission") a tender offer statement on Schedule TO, including an Offer to Purchase and related Letter of Transmittal, which includes the terms of the tender offer. Additionally, Constellation filed a Schedule 14D-9 with the Commission containing the recommendation of its Board of Directors that Constellation shareholders tender their shares into the tender offer. The Schedule TO, Schedule 14D-9, Letter of Transmittal and other tender offer documents can be obtained free of charge at the website maintained by the Commission at www.sec.gov or by contacting the information agent for the tender offer, Innisfree M&A Incorporated as described in the tender offer documents.

Advisors

Goldman Sachs Bank Europe SE acted as financial advisor to MorphoSys and Skadden, Arps, Slate, Meagher & Flom LLP as its legal advisor. Centerview Partners LLC acted as financial advisor to Constellation and Wachtell, Lipton, Rosen & Katz as its legal advisor.

KAHR, a cancer immunotherapy company developing novel multifunctional immuno-recruitment proteins, reported the first closing of an investment round raising $46.5 million (Press release, KAHR Medical, JUN 16, 2021, View Source [SID1234584051]). The financing was led by aMoon with participation from new investors BVF Partners LP, DAFNA Capital Management LLC, Peregrine Ventures, Shavit Capital and the Cancer Focus Fund. Existing investors also participated in this financing, including Flerie Invest AB, Oriella Limited (CBG, chaired by Vincent Tchenguiz), Pavilion Capital, Hadasit Bio Holdings Ltd (HBL) and Mirae Asset.

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Proceeds from the financing will be used to advance clinical development of the Company’s lead product candidate, DSP107, a first-in-class CD47x41BB targeting fusion protein for the treatment of solid and blood cancers, through multiple Phase 1/2 studies as well as the development of its preclinical pipeline including DSP502, a TIGITxPD1 fusion protein, and DSP216, a LILRB2xSIRPa fusion protein, through IND-enabling studies.

"The successful financing round of this respected syndicate of investors is a testament to our breakthrough technology platforms and promising next-generation multifunctional, immunotherapeutic pipeline," said Yaron Pereg, Ph.D., Chief Executive Officer of KAHR. "Cancer treatment is challenging in that cancer cells continuously change and develop resistance to existing treatments. Another notable hurdle is the ability of cancer cells to evade recognition and elimination by the body’s own immune system. Our novel, multi-pronged product candidates are specifically designed to address these challenges by unmasking cancer cells for immune recognition, and at the same time, providing signals to effectively trigger a targeted synergistic activation of anticancer immunity."

"Our unique approach positions us in the forefront of cancer immunotherapy, and through this financing we can continue to advance our clinical asset and accelerate our preclinical projects into clinical development across multiple cancer indications for the benefit of patients who are non-responsive or refractory to existing immunotherapies," added Dr. Pereg.

Gur Roshwalb, MD, Partner, aMoon, said, "KAHR’s multifunctional immunotherapeutic platform has enormous potential to address unmet needs in immuno-oncology. We are particularly excited about KAHR’s differentiated first-in-class CD47x41BB targeting compound, which potentially harnesses both the innate and adaptive immune systems to target solid and hematologic tumors."

KAHR develops smart immune-recruitment cancer drugs that activate a targeted immune response by converting cancer camouflage into beacons for the immune system to attack. The Company’s lead product candidate, DSP107 is a first-in-class CD47x41BB targeting compound that simultaneously binds cancer cells and immune cells, linking them together for maximal activation of the immune system against the tumor. DSP107 is designed to weaken the tumor’s defenses on one hand, and activate an effective, local response of both innate and adaptive immunity on the other hand. Specifically, DSP107 binds to and inhibits CD47, an immune checkpoint protein overexpressed in many cancer types that enables the tumor to evade immune recognition and attack. Simultaneously, DSP107 binds 41BB on T-cells, stimulating their activation. These activities lead to targeted immune activation through both macrophage and T-cell mediated tumor destruction.

DSP107 is currently being tested in a Phase 1/2 multicenter, open-label, dose-escalation and expansion study assessing the safety, pharmacokinetics and pharmacodynamics of DSP107 as a monotherapy and in combination with Roche’s PD-L1-blocking checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced solid tumors. In addition, KAHR expects to initiate an open label, dose escalation and expansion Phase 1/2 study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of DSP107 as monotherapy and in combination with azacytidine or with azacytidine plus venetoclax in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and T-cell lymphoproliferative diseases in the coming months.

Oppenheimer & Co. Inc. and Solebury Capital acted as placement agents for the offering.