On September 9, 2020 Oasmia Pharmaceutical AB (publ)reported that Interim report for the period May 1 – July 31, 2020 (Press release, Oasmia, SEP 9, 2020, View Source [SID1234564799])

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SIGNIFICANT EVENTS DURING THE FIRST QUARTER
Oasmia announced in May the outcome of a strategic review to deliver long-term, profitable growth as a specialty pharma company. As a result of the review, Oasmia will discontinue commercial manufacturing and implement cost reductions that will result in savings of MSEK 100 on an annual basis and a monthly burn rate of below MSEK 10.
An Extraordinary General Meeting in May elected existing Board member Anders Härfstrand as new Chairman of the Board and Birgit Stattin Norinder as new member of the Board. Jörgen Olsson, former Chairman of the Board, and Gunilla Öhman, former Board member, stepped down from the Board.
Oasmia signed in June a Phase 1b Trial Agreement with SAKK, the Swiss Group for Clinical Cancer Research, for evaluation of docetaxel micellar for the treatment of metastatic prostate cancer.
In July Oasmia’s partner Elevar Therapeutics and Tanner Pharma Group announced a global Named Patient Program to provide access to Apealea in areas outside of the United States.
The outbreak of COVID-19 and its effects around the world accelerated during the first quarter of the financial year. The pandemic has entailed heavily reduced access to health care providers and oncologists, which continues to have a profound negative impact on the marketing activities of the company.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
In August Oasmia appointed Peter Selin as Chief Business Officer.
Oasmia’s CFO Michael af Winklerfelt resigned from his role in August.
In September Oasmia’s Nomination Committee revised its proposal for the AGM regarding Board of Directors and Sven Rohmann notified that he is no longer available for re-election.
In September Oasmia appointed Fredrik Järrsten as Chief Financial Officer.
FIRST QUARTER: MAY 1, 2020 – JULY 31, 2020
Consolidated net sales amounted to TSEK 208 (182)
Operating income was TSEK -49,220 (-35,764)[3]
Net income after tax amounted to TSEK -53,105 (-39,783)[3]
Earnings per share was SEK -0.12 (-0.13)[3,4]
CEO’S COMMENTS
During the first quarter at Oasmia, we continued to work to deliver the strategic vision we set out following the announcement of the global strategic partnership with Elevar Therapeutics to commercialize our anti-cancer therapy Apealea.

Oasmia retains the rights to Apealea in the Nordic countries under the agreement with Elevar and is now making the product commercially available. The Covid-19 pandemic has inevitably impacted the ability of our medical scientific liaisons to meet oncologists during the quarter. An easing of lockdown restrictions will help resuming medical activities to return to more normal levels during the rest of the year.

Elevar entered into an agreement with Tanner Pharma Group in July to establish a named patient program that will facilitate patient access to Apealea in countries outside the US where it is not yet commercially available. The goal of the program is to assist cancer patients who have no alternative therapeutic options to get access to the drug. Apealea is the only cremophor-free product approved in Europe for use in combination with carboplatin for the treatment of adults with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. The initial target population for ovarian cancer is therefore patients with potential or previously established hypersensitivity reactions to currently used solubility enhancer containing paclitaxel formulations. We hope that this will make them particularly eligible to our XR-17 based paclitaxel formulation.

The collaboration with Elevar that started in 2020, as well as the transfer of all commercial manufacturing of Apealea to Baxter at the end of 2018, were important developments in realigning our growth strategy, enabling us to focus resources where they can bring the best return for shareholders.

The Board’s long-term vision is to build a cash flow-positive specialty pharmaceutical company. To help achieve this, we have implemented a strategic reorganization of Oasmia to focus on R&D and Business Development and to reduce unnecessary expenditure. With a proven technology in XR-17, a highly promising approved anti-cancer product, Apealea, and a global commercialisation agreement worth up to $678 million plus royalties, we are well positioned to grow through M&A and licensing deals for late-stage and marketed products. We will seek further opportunities to apply our proprietary XR-17 solubility-enhancing technology platform, primarily in oncology but also in other therapeutic areas. We are also looking at the potential to out-license the technology in non-core applications. We are already in the process of reviewing strategic options for our Animal Health business.

We will continue to drive the development of our pipeline of XR-17-based products and leverage the Company’s manufacturing expertise for R&D. Current promising lead programs include docetaxel micellar in metastatic prostate cancer. In June, we signed an agreement with the Swiss research group SAKK to conduct the first clinical trial of docetaxel micellar in advanced prostate cancer. Oasmia’s docetaxel micellar formulation is based on XR-17, which enables greater use of otherwise water-insoluble cancer drugs while reducing the side effects or need for additional medications associated with traditional solubility enhancers. In addition, we continue the assessment of XR-19, the dual encapsulation technology platform.

During the rest of 2020 we will continue to advance key areas of our growth strategy, including working closely with Elevar to deliver key milestones for Apealea and support efforts to identify the most appropriate commercial partners for the product in Europe and China. The appointment of Peter Selin as Chief Business Officer, announced a few weeks ago, together with our strong cash position, will be invaluable as we continue to pursue growth through M&A and in- and out-licensing opportunities that complement our technology and business model.

I look forward to keeping you updated on our progress. Please accept my thanks for your patience and continued support as we further transform Oasmia into a sustainable and profitable growth business with long-term potential. Above all, we are here to help patients to better manage their cancer diseases.

On September 9, 2020 Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company focused on the treatment of serious disease, reported that the U.S. Food and Drug Administration (FDA) has granted Rare Paediatric Disease Designation (RPDD) to 64Cu-SARTATE, a diagnostic for the clinical management of neuroblastoma (Press release, Clarity Pharmaceuticals, SEP 9, 2020, View Source [SID1234564751]).

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Dr Alan Taylor, Clarity’s Executive Chairman, commented, "We are very excited to have received the RPDD status for the diagnostic application of SARTATE in children with neuroblastoma. This comes shortly after Clarity has been granted RPDD for the treatment of neuroblastoma with 67Cu-SARTATE for the therapeutic application, announced on the 3rd of June 2020."

The FDA defines a "rare paediatric disease" (RPD) as a serious or life-threatening disease primarily affecting individuals aged 18 years or younger that impacts fewer than 200,000 people in the United States. The program is intended to facilitate development of new drugs and biologics for the prevention and treatment of RPDs.

Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.1 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.2

Upon FDA marketing approval of 64Cu-SARTATE for neuroblastoma with RPD designation, Clarity would be eligible to receive a tradable Priority Review Voucher (PRV). The PRV shortens the FDA review period of a New Drug Application (NDA) for another product to an expedited period of six months, which is a huge benefit for drug developers. The voucher, if awarded, may be sold or transferred to another company. To date, PRVs have been sold for between US$67.5 million and US$350 million, with the most recent PRV being purchased by Merck from Lumos Pharma for a value of US$100 million in July 2020.3

"With 67Cu-SARTATE, a therapeutic for the clinical management of neuroblastoma, also having been awarded RPDD status4, Clarity may be eligible for two Priority Review Vouchers if both treatments get FDA approval," commented Dr Taylor.

"We have seen incredibly strong support from our collaborators and advisors in the development of SARTATE for neuroblastoma and are looking forward to the results from our US-based trial at the Memorial Sloan Kettering Cancer Centre5. It is evident that there is a large unmet need in the management and treatment of this devastating disease and we are aiming to improve outcomes for this important patient population with both the diagnostic and therapeutic applications of SARTATE" said Dr Taylor.

On September 8, 2020 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to transform the lives of patients with unmet medical needs, reported that its lead asset, first-in-class agent Plinabulin, has received the Breakthrough Therapy Designation (BTD) for the chemotherapy-induced neutropenia (CIN) indication from both the U.S. Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (Press release, BeyondSpring Pharmaceuticals, SEP 8, 2020, View Source [SID1234585747]).

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The FDA’s BTD is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition in which clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The CDE in China established its BTD program in July 2020 to facilitate the research and development of innovative drugs that treat severe life-threatening or quality-of-life impairing diseases with no existing therapy or with proven evidence to demonstrate clear clinical benefits compared to existing therapies. Products with BTD from the CDE may be considered for conditional approval and priority review when submitting New Drug Applications (NDAs).

"Receipt of Breakthrough Therapy Designation from the FDA acknowledges both the significant unmet need among patients with CIN and the highly encouraging clinical results generated by Plinabulin," said Douglas Blayney, M.D., global Principal Investigator for Plinabulin’s CIN studies and Professor of Medicine at the Stanford University School of Medicine. "This should expedite Plinabulin’s move into the clinic, which is beneficial for patients. The currently approved CIN prevention agents are all G-CSF-based and not available to all patients. Even with the use of G-CSFs, over 80 percent of cancer patients undergoing chemotherapy may still experience Grade 4 neutropenia, which could lead to severe infection, hospitalization and even death. Thus, CIN still represents an unmet medical need."

"The clinical profile Plinabulin has shown truly represents a breakthrough in the CIN space since G-CSFs," added Ramon Mohanlal, M.D., Ph.D., MBA, Chief Medical Officer and Executive Vice President, Research and Development, at BeyondSpring. "We look forward to continuing to work with the FDA as we advance the development of Plinabulin to address this urgent medical need."

The Breakthrough Therapy application is based on the strength of the totality of the clinical data generated so far:

Positive interim analysis results from the PROTECTIVE-2 Phase 3 study – The clinically meaningful primary endpoint was the prevention of severe neutropenia, an "industry first," building on the previous standard for approval, the Duration of Severe Neutropenia (DSN). In the protocol-specified interim analysis, Plinabulin, in combination with Neulasta, was significantly better than Neulasta alone in achieving the primary endpoint with p<0.01, along with a well-tolerated safety profile and fewer Grade 4 adverse events, compared to Neulasta alone.
These results were further strengthened by the Company’s other CIN studies that have confirmed Plinabulin’s early onset action in Week 1 with protecting neutrophils in various cancer types and various chemotherapies, which is complementary to Week 2 neutrophil protection with G-CSFs.
The Company expects to report the full PROTECTIVE-2 Phase 3 topline data in Q4 2020 and file an NDA with the FDA by the end of 2020. The Company has submitted an NDA for Plinabulin for the CIN indication to the NMPA on a rolling basis in Q1 2020.

About Chemotherapy-Induced Neutropenia (CIN)
CIN is a common side effect in cancer patients undergoing treatment that involves the destruction of a type of white blood cell, the neutrophil, which is a patient’s first line of defense against infections. Patients with Grade 4 (severe) neutropenia have an abnormally low concentration of neutrophils, which may lead to infections, hospitalization and death.

G-CSFs are the current standard of care for CIN prevention. However, G-CSFs have limitations in reducing Grade 4 neutropenia with high-risk chemotherapy. Neutropenia, if severe enough, may cause doctors to lower target doses of chemotherapy, end therapy early and / or delay chemotherapy cycles, each of which has a negative effect on long-term outcomes of cancer care.

Despite these limitations annual global use of G-CSFs is more than 4.3 million cycles per year (CPY). The U.S. (1.3 million CPY) and China (1.6 million CPY) account for more than two-thirds of the global CIN market. Plinabulin’s demonstrated clinical profile in combination with G-CSFs has the potential to build on this existing base and improve the standard of care for patients and practitioners.

About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulin’s CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

About Plinabulin in CIN Study
The PROTECTIVE-1 (Study 105) and PROTECTIVE-2 (Study 106) trials are both multicenter, double-blind, active controlled Phase 3 trials to support Plinabulin’s broad application in preventing CIN: Plinabulin for concurrent administration with myelosuppressive chemotherapy regimens in patients with non-myeloid malignancies for the presentation of chemotherapy-induced neutropenia (CIN).

PROTECTIVE-1 (Study 105)
This study was designed to evaluate the safety and efficacy in non-small cell lung cancer (NSCLC), breast cancer and prostate cancer patients with risk factors, treated with docetaxel (Day 1 dose) in a 21-day cycle with a single dose of Plinabulin (40mg, Day 1 dose) versus a single dose of Neulasta (6mg, Day 2). Docetaxel is one example of an intermediate-risk chemotherapy. This is a non-inferiority study in CIN efficacy comparing Plinabulin and Neulasta in high-risk patients (intermediate chemotherapy, plus one or more additional risk factor). Study 105 Phase 3 interim data had achieved statistical significance based on the primary endpoint of the Duration of Severe Neutropenia (DSN) in the first cycle.

PROTECTIVE-2 (Study 106)
This study was designed to evaluate the safety and efficacy in breast cancer, treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle with Plinabulin (40 mg, Day 1 dose) in combination with Neulasta (6 mg, Day 2 dose) versus a single dose of Neulasta (6 mg, Day 2 dose) alone. TAC is an example of high-risk chemotherapy. Plinabulin and G-CSFs have complementary mechanisms in preventing chemotherapy-induced neutropenia (CIN). This is a superiority study in CIN efficacy in the rate of Grade 4 neutropenia prevention (primary endpoint), comparing the combination head-to-head against Neulasta, and is currently enrolling. Literature shows that the Grade 4 neutropenia rate for TAC and Neulasta at 6 mg is 83 to 93 percent, which presents severe unmet medical needs.

Covance is the clinical contract research organization (CRO) for patient recruitment and monitoring of global sites for this study. The CIN studies are conducted in over 60 clinical centers in the U.S., China and Europe. In addition, Absolute Neutrophil Count (ANC) data, which is used to calculate these endpoints, was obtained through central laboratory assessments by Covance Bioanalytical Methods using standardized and validated analytical tests.

On September 8, 2020 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported that it intends to offer and sell, subject to market conditions, 10,000,000 shares of its common stock in an underwritten public offering (Press release, Athenex, SEP 8, 2020, View Source [SID1234573873]). In addition, Athenex expects to grant the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is subject to market 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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SVB Leerink, RBC Capital Markets and Evercore ISI are acting as joint book-running managers and Oppenheimer & Co. is acting as lead manager for the offering.

The securities described above are being offered by Athenex pursuant to a shelf registration statement on Form S-3 (File No. 333-227492) that was filed with the Securities and Exchange Commission (the "SEC") on September 24, 2018 and became effective upon filing. A preliminary 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. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at (877) 822-4089, or by email at [email protected]; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, or by telephone at (888) 474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there by any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On September 8, 2020 Manifold Bio, a spinout from George Church’s lab at Harvard Medical School focused on dramatically increasing the throughput of protein therapeutics testing in vivo, announced the close of a $5.4 million Series Seed investment round (Press release, Manifold Bio, SEP 8, 2020, View Source [SID1234572307]). Playground Global led the round and was joined by pre-seed lead Fifty Years and early investors GETTYLAB and Allston Venture Fund. The investment will enable the company to expand the team and accelerate the development of a proprietary protein quantitation platform.

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Manifold Bio was founded by CEO Gleb Kuznetsov, Ph.D., and CSO Pierce Ogden, Ph.D., along with George Church, Ph.D., Professor of Genetics at Harvard Medical School and the Wyss Institute for Biologically Inspired Engineering. They are joined by co-founder and Head of Business Development Shane Lofgren who previously helped build companies that emerged from Stanford and MD Anderson.

"The most valuable data on a candidate drug comes from testing it in a living system," says co-founder and CEO Gleb Kuznetsov. "Despite the advent of high-throughput technologies early in the discovery pipeline, drug development teams eventually run into the bottleneck of testing only one molecule at a time in the most relevant biological assays and animals. At Manifold Bio, we’re focused on building a platform that removes this barrier and allows us and our partners to pursue cures for devastating diseases much more rapidly."

"We’ve seen exponential advances that allow us to synthesize millions of strands of DNA and sequence billions of DNA bases, but the number of drugs that can be tested in relevant animal models remains in the single digits," said co-founder George Church, who introduced Manifold Bio in a keynote last week at PEGS, the premier industry protein engineering conference. "With the technology and talented interdisciplinary team we’re building at Manifold Bio, we’ll be able to bring the massively parallel economics of multiplexing to bear on engineering protein therapeutics."

Manifold Bio’s platform will allow multiplexed (pooled) tracking and quantification of thousands of unique protein designs, including monoclonal antibodies and other protein therapeutic scaffolds, across a range of complex testing environments.

"By turning protein engineering into a DNA synthesis and sequencing problem, we’re able to learn biological design principles directly from rich data generated by our novel in vivo assays," co-founder and CSO Pierce Ogden said. Last year, Ogden published a ground-breaking paper in Science demonstrating in vivo screening of more than 200,000 gene therapy virus designs. "Now, we’re building the platform technology for the larger space of protein therapeutics. The key is making it possible to test and quantify mixtures of designs directly where it matters–in vivo disease models. These advances will pave the way toward our goal of transforming drug discovery into measurement-driven drug design."

"Too many of the drug discovery startups we see are focused primarily on computation and improving the beginning of the drug development funnel, only to revert to traditional and painfully inefficient artisanal methods as therapies approach the clinic," said Jory Bell, Partner at Playground Global. "Manifold Bio has developed an entirely new approach to engineering which profoundly impacts all phases of development."

"By enabling high throughput in vivo screening of protein therapeutics, Manifold Bio can discover new biologics at scale," said Seth Bannon, Founding Partner at Fifty Years. "Their approach allows generating valuable data faster and at a lower financial and ethical cost, leading to cures that have evaded traditional methods."

Playground Global’s Jory Bell will join Manifold Bio’s board of directors.