On June 11, 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 March 31, 2020 (Press release, BeyondSpring Pharmaceuticals, JUN 11, 2020, View Source [SID1234560998]).

"During the first quarter, we continued to make progress in the two lead indications for Plinabulin for both the prevention of chemotherapy-induced neutropenia (CIN) and treatment of non-small cell lung cancer (NSCLC)," said Dr. Lan Huang, Co-Founder, Chairman and Chief Executive Officer. "Our recent data from PROTECTIVE-2 Phase 2 showed Plinabulin combined with G-CSF improves chemotherapy compliance compared to G-CSF alone, which potentially leads to better clinical outcomes. The Plinabulin-G-CSF combination’s potential to prevent infection and hospitalization becomes even more important to the physicians, patients and the healthcare system in the COVID-19 pandemic. We expect to reach the pre-specified interim analysis for PROTECTIVE-2 Phase 3 this month to evaluate superiority in CIN, which has the potential to mark the first significant enhancement in preventing neutropenia in 30 years."

"With over 1,200 patients enrolled to date for Plinabulin clinical programs, we believe we are well-positioned to capitalize on our upcoming regulatory milestones with multiple New Drug Application (NDA) filings followed by near term commercial opportunities. Looking ahead, we continue to advance our clinical studies to support our view of Plinabulin as a ‘pipeline in a drug’ and believe its potential in improving standard of care in CIN prevention and cancer treatments will help many patients in need globally."

Select First-Quarter 2020 and Recent Operational Highlights

Chemotherapy-Induced Neutropenia (CIN)

PROTECTIVE-2 Phase 2 for Chemotherapy-Induced Neutropenia Shows Positive Results in Chemotherapy Optimization with Potentially Better Clinical Outcomes

In June 2020, BeyondSpring announced that PROTECTIVE-2 Phase 2 superiority trial for CIN shows that Plinabulin in combination with Neulasta (pegfilgrastim), a long-lasting G-CSF, which is a predominant therapy to treat CIN, enables more cancer patients to receive the optimal chemotherapy dose and regimen, which potentially leads to better clinical outcomes.

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In breast cancer patients treated with docetaxel, doxorubicin and cyclophosphamide (TAC, a high-risk chemotherapy) with 20mg/m2 of Plinabulin combined with 6mg of Neulasta (n=16) compared with 6mg of Neulasta alone (n=22), Plinabulin + G-CSF improved compliance with targeted chemotherapy

Dose reduction (over 15 percent): only 6.3 percent of patients in the Plinabulin-Neulasta combination arm versus 22.7 percent in Neulasta arm – a 72 percent improvement

Downgraded regimen (from TAC, to docetaxel and cyclophosphamide, or TC): No (0 percent) patients in the Plinabulin + G-CSF arm downgraded chemotherapy from the TAC regimen to the TC regimen versus 18.2 percent in the Neulasta arm – p < 0.05

Plinabulin’s Mechanism of Action Complements Neulasta in Cancer Treatment

In May 2020, two Company abstracts were presented at this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program, evaluating Plinabulin alongside Neulasta.

BeyondSpring’s e-publication, titled, "Comparison of CD34+ mobilization effects of standard dose pegfilgrastim (Peg) versus low-dose peg combined with plinabulin (Plin)," demonstrates the efficacy of Plinabulin-Neulasta combination in increasing CD34+ counts for patients, with fewer adverse events

Additionally, BeyondSpring’s poster presentation, titled, "Head-to-head comparison of the non-G-CSF small molecule single agent (SA) plinabulin with SA pegfilgrastim for the prevention of docetaxel chemotherapy (chemo)-induced neutropenia (CIN) in the protective-1 trial," compares Plinabulin versus Neulasta as an effective monotherapy for CIN prevention

Non-Small Cell Lung Cancer (NSCLC)

DSMB Recommends DUBLIN-3 Phase 3 NSCLC to Continue Without Modification

In June 2020, BeyondSpring reported it had 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, DSMB advised BeyondSpring to continue the study without any modifications

DUBLIN-3 is a global Phase 3 trial for Plinabulin, in combination with docetaxel versus docetaxel alone, for the treatment of second- / third-line EGFR wild-type NSCLC

Thus far, over 600 cancer patients have been dosed with Plinabulin, which has demonstrated good tolerability and satisfies the safety database standard of both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA)

Intellectual Properties

BeyondSpring Granted U.S. Patent for Plinabulin to Treat Severe CIN from Taxane in Cancer Patients

In May 2020, the U.S. Patent and Trademark Office (USPTO) granted BeyondSpring a new patent for methods of treating severe CIN in cancer patients treated with taxane with protection through 2033. This patent establishes Plinabulin’s beneficial effects in reducing CIN associated with taxane, one of the most commonly used chemotherapies

The Company currently owns 76 patents, including 17 issued U.S. patents, for Plinabulin and its analogs with protection through 2036

Financial Results for the Three Months Ended March 31, 2020

Research and development ("R&D") expenses were $13.7 million for the quarter ended March 31, 2020, compared to $6.3 million for the quarter ended March 31, 2019. The $7.4 million increase was largely attributable to an increase of $4.4 million in clinical trial expenses and an increase of $3.0 million in non-cash share-based compensation.

Selling, general and administrative ("SG&A") expenses were $2.9 million for the quarter ended March 31, 2020, compared to $1.6 million for the quarter ended March 31, 2019. The $1.3 million increase was mainly due to a $0.6 million increase in commercial and marketing expense, a $0.3 million increase in salary, wages and benefits expense, and a $0.4 million increase in other expenses.

Net loss attributable to the Company was $16.1 million for the quarter ended March 31, 2020, compared to $7.3 million for the quarter ended March 31, 2019.

As of March 31, 2020, the Company had a cash balance of $24.9 million. The Company believes currently available financial resources will be sufficient to support its clinical trials and submit NDAs in the U.S. and China for Plinabulin for the CIN and NSCLC indications, as well as to advance its immuno-oncology pipeline and ubiquitination protein degradation research platform.

Anticipated Milestones

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

Interim topline data readout for PROTECTIVE-2 Phase 3 for CIN – June 2020

Final data readout for PROTECTIVE-2 Phase 3 for CIN – H2 2020

Final data readout for PROTECTIVE-1 Phase 3 for CIN – H2 2020

NDA submission for Plinabulin for CIN in the U.S. – H2 2020

Final data readout for DUBLIN-3 for NSCLC – H2 2020

NDA submission for Plinabulin for NSCLC in China – H2 2020

NDA submission for Plinabulin for NSCLC in the U.S. – H1 2021

On June 11, 2020 The Board of Directors of Bristol Myers Squibb (NYSE:BMY) reported a quarterly dividend of forty-five cents ($0.45) per share on the $.10 par value Common Stock of the corporation (Press release, Bristol-Myers Squibb, JUN 11, 2020, View Source [SID1234560997]). The next quarterly dividend will be payable on August 3, 2020, to stockholders of record at the close of business on July 6, 2020.

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The directors also declared a quarterly dividend of fifty cents ($0.50) per share on the $2.00 Convertible Preferred Stock of the corporation, payable September 1, 2020 to stockholders of record at the close of business on August 4, 2020.

On June 11, 2020 Immunomic Therapeutics, Inc. reported that it will present preclinical data on its investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression), that elicits potent immune responses when used with its investigational UNITE vaccine, ITI-3000, in mice (Press release, Immunomic Therapeutics, JUN 11, 2020, View Source [SID1234560996]). UNITE fuses a tumor-associated antigen, here a mutated form of the large T antigen (LT) of Merkel cell polyomavirus (MCPγV), with lysosomal-associated membrane protein 1 (LAMP1). This lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response, as ITI-3000 activated antigen-specific CD4+ T cells in vivo. The data will be presented at the AACR (Free AACR Whitepaper) Virtual Annual Meeting II, June 22-24, 2020.

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"ITI-3000 is an innovative and novel targeted approach to a MCPγV vaccine," says Teri Heiland, Ph.D., Immunomic’s Chief Scientific Officer. "We are highly encouraged by this data and look forward to continuing to advance ITI-3000 toward the clinic."

The majority of Merkel cell carcinomas (MCC) are associated with Merkel cell polyomavirus (MCPyV) infection, making LT an attractive target for therapeutic cancer vaccines. MCPγV integrates into the host genome, resulting in expression of a truncated form of the viral LT in infected cells. While induction of tumor-reactive CD8+ T cells is a major goal of cancer therapy, CD4+ T cells provide essential support to CD8+ T cells by promoting their expression of cytotoxic effector molecules and increasing their migratory capacity. Cytokines secreted by CD4+ T cells, such as IFNγ, can also exert desirable effects on the tumor microenvironment. Hence, a cancer vaccine that promotes potent, antigen-specific CD4+ T cell responses to MCPγV-LT may drive robust anti-tumor immune responses.

Poster Title: LAMP1 targeting of the large T antigen of Merkel cell polyomavirus elicits potent CD4+ T cell responses and prevents tumor growth

Session Category: Immunology

Session Type: Poster Session

Session Title: Vaccines

Poster Number: 4585

Poster Session Date and Time: June 22, 2020 9AM-6PM

Location: Virtual Poster Presentation

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On June 11, 2020 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported the closing of an underwritten public offering of 7,108,796 shares of its common stock, which included 927,324 shares that were issued pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $28.31 per share (Press release, Fate Therapeutics, JUN 11, 2020, View Source [SID1234560995]). Aggregate gross proceeds from this offering, including exercise of the option, were approximately $201.3 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, including the construction, commissioning and qualification of its new facility, the conduct of preclinical research and development, and for general corporate purposes.

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Subject to the expiration or early termination of applicable waiting periods relating to certain antitrust filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, the Company also expects to sell to Johnson & Johnson Innovation-JJDC, Inc. in a private placement, 1,766,160 shares of common stock for an aggregate purchase price of approximately $50.0 million, at a price per share equal to the price to the public in the underwritten public offering.

Jefferies, SVB Leerink, Barclays and Guggenheim Securities acted as joint book-running managers for the offering. Mizuho Securities acted as lead manager for the offering, and H.C. Wainwright & Co. acted as co-manager for the offering.

The securities described above were offered by Fate Therapeutics pursuant to a shelf registration statement on Form S-3 (File No. 333-228513) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A final prospectus supplement related to the offering was filed with the SEC with a filing date of June 10, 2020 and is available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the securities offered may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 547-6340; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6218 or by email at [email protected]; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847 or by email at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at [email protected].

On June 11, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it has entered into definitive agreements with fundamental healthcare investors for the purchase and sale of 14,000,000 of its shares of common stock at a purchase price of $1.25 per share in a registered direct offering (Press release, Curis, JUN 11, 2020, View Source [SID1234560994]). The closing of the offering is expected to occur on or about June 15, 2020, subject to the satisfaction of customary closing conditions.

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JonesTrading Institutional Services LLC ("JonesTrading") is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be $17.5 million, before deducting the placement agent’s fees and other offering expenses payable by Curis.

Curis intends to use the net proceeds from the public offering, together with its existing cash, cash equivalents and investments, to continue development of CA-4948 and CI-8893, and for general working capital and capital expenditures.

The shares are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224627) that was filed with the United States Securities and Exchange Commission ("SEC") on May 3, 2018, and declared effective by the SEC on May 17, 2018. A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. The offering is being made only by means of a prospectus and related prospectus supplement. When available, electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained from JonesTrading Institutional Services LLC by calling (212) 907-5332, or by e-mailing [email protected].