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Nordic Nanovector ASA: Invitation to Third Quarter 2018 Results Presentation and Webcast

On November 2, 2018 Nordic Nanovector ASA (OSE: NANO) reported that it will announce its third quarter 2018 results on Tuesday, 6 November 2018 (Press release, Nordic Nanovector, NOV 2, 2018, View Source [SID1234553488]).

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A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CET on 6 November at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: HOLMENKOLLEN

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2018 from 7:00 am CET the same day.

U.S. FDA APPROVES UDENYCA™ (PEGFILGRASTIM-CBQV)

On November 2, 2018 Coherus BioSciences, Inc. (NASDAQ: CHRS), reported that the U.S. Food and Drug Administration (FDA) has approved UDENYCA (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy (Press release, Coherus Biosciences, NOV 2, 2018, View Source [SID1234531675]). UDENYCA is Coherus’ first drug to receive FDA or EC approval.

"We are excited to announce that Coherus has received FDA approval for UDENYCA. I want to thank the Coherus team, our strategic partners, and the U.S. Food and Drug Administration for this extraordinary achievement," said Denny Lanfear, Chairman, CEO and President of Coherus BioSciences. "The list price of Neulasta has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the U.S. We believe that competition is essential in controlling burdensome price increases, and UDENYCA will play an important role in curbing that spend when launched. Our in-depth understanding of the market will allow us to deliver significant value to patients, payors, and providers in the U.S., including 340B hospitals, small clinics and small hospitals."

"For a number of reasons we believe the oncology marketplace is ideal for biosimilars, and we are committed to a vigorous product launch," said Chris Thompson, Senior Vice President of Sales. "Our oncology-focused, highly capable and fully-staffed commercial team is in place. We are confident that our U.S.-based manufacturing network has the finished goods in inventory to meet our highest expected demand for an extended period."

The approval of UDENYCA was supported by a comprehensive analytical similarity package, as well as pharmacokinetic, pharmacodynamic and immunogenicity studies, including over 600 healthy subjects.

"UDENYCA’s robust clinical package includes a dedicated immunogenicity similarity study in over 300 healthy subjects," said Barbara Finck, M.D., Chief Medical Officer of Coherus BioSciences. "In support of that study, and as part of our commitment to ensuring patient safety, we deployed a battery of sensitive immunogenicity assays. This effort not only supported the biosimilarity of UDENYCA, but also advanced the understanding of the immunogenic response of pegfilgrastim products."

The European Commission approved UDENYCA on September 21, 2018.

The company will provide additional details with respect to pricing and launch timing on the November 8 earnings call.

About UDENYCA
UDENYCA (pegfilgrastim-cbqv), formerly CHS-1701, is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

INDICATION
UDENYCA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use
UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATION: Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

WARNINGS AND PRECAUTIONS:

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCATM in patients with ARDS.
Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCATM in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCATM if causality is likely.
Adverse Reactions: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Autolus Therapeutics to Present New Data at the ASH Annual Meeting

On November 2, 2018 Arix Bioscience plc (LSE: ARIX) ("Arix"), a global healthcare and life science company supporting medical innovation notes one of its Group Businesses, Autolus Therapeutics plc (NASDAQ: AUTL) (Autolus), reported that it will present one oral and two poster presentations related to its AUTO3 and AUTO5 programs at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held December 1-4, 2018 in San Diego, CA (Press release, Autolus, NOV 2, 2018, View Source [SID1234530693]).

The announcement can be accessed on Autolus’ investor website at View Source and full text of the announcement from Autolus is contained below

CytRx Corporation Reports Third Quarter 2018 Financial Results

On November 2, 2018 CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the quarter ended September 30, 2018, and provided an overview of recent accomplishments and plans for its research and development programs (Press release, CytRx, NOV 2, 2018, View Source [SID1234530692]).

"The third quarter of 2018 was highlighted by the filing of a provisional patent by Centurion BioPharma for the breakthrough albumin companion diagnostic (ACDx) for use alongside our innovative LADR (Linker Activated Drug Release) assets," said Eric Curtis, CytRx’s President and Chief Operating Officer. "This new intellectual property is an important component of the overall LADR value proposition and will enhance our efforts to secure a strategic partnership to further advance these unique, promising assets, with the overarching goal of bringing these albumin binding ultra-high potency drug candidates to the physicians and patients who need them."

"Also during the quarter, we were pleased to make the final payment under our long-term loan agreement, and thereby extinguishing all of our outstanding debt. We also saw the expiration of approximately 3.2 million outstanding warrants for shares of our common stock, improving our overall capital structure."

Third Quarter 2018 and Recent Highlights

Centurion BioPharma Corporation

Breakthrough Personalized Medicine Companion Diagnostic Filed for Albumin-Binding LADR Drug Candidates. In July 2018, Centurion filed a provisional patent application with the U.S. Patent and Trademark Office covering its unique albumin companion diagnostic (ACDx) for use alongside its albumin binding ultra-high potency LADR drug candidates. The goal of ACDx is to identify patients with cancer who are most likely to benefit from the treatment with the Company’s lead assets, LADR-7, LADR-8, LADR-9 and LADR-10 and any albumin-binding drugs the Company may generate in the future.
CytRx Corporation

Receipt of Milestone Payment from Orphazyme A/S. In September 2018, CytRx announced receipt of a milestone payment totaling $250,000 (USD) from Orphazyme A/S (CPH: ORPHA). The payment was a result of Orphazyme dosing the first patient in their Phase 3 clinical trial evaluating arimoclomol in patients with amyotrophic lateral sclerosis. Orphazyme, a public company trading on the Nasdaq Copenhagen exchange, is testing arimoclomol in three additional indications beyond ALS, including Niemann-Pick disease Type C, Gaucher disease and sporadic Inclusion Body Myositis. Should arimoclomol be approved for NPC in Europe, CytRx will receive a $4 million milestone payment, plus royalties. Additional arimoclomol milestones include $6 million upon approval in the U.S. and $2 million upon approval in Japan, plus royalties on net sales in all territories.
Paid Off Long-Term Loan. In August 2018, CytRx announced that it made the final payment under a long-term loan agreement. As of August 1, 2018, the loan was paid in full, which extinguished all of CytRx’s outstanding debt.
Expiration of the Majority of Outstanding Warrants. In July 2018, CytRx announced the expiration of warrants for approximately 3.2 million shares of its common stock. CytRx believes the expiration of these warrants, the majority of which were associated with a public offering in December 2016, eliminates overhang and provides additional common share float stability.
Participated in Three Institutional Investor Conferences. During the third quarter, CytRx participated in three institutional investor conferences in New York City, including the H.C. Wainwright & Co. 20th Annual Global Investment Conference, the 2018 MicroCap Conference and the Singular Research Summer Solstice 2018 Conference. At each conference, CytRx executive management made a formal presentation and had one-on-one meetings with institutional investors.
Third Quarter 2018 Financial Results

CytRx reported cash and cash equivalents of $24.7 million as of September 30, 2018.

Net loss for the quarter ended September 30, 2018, was $3.3 million, or $(0.10) per share, compared with a net loss of $5.1 million, or $(0.19) per share, for the comparative 2017 period, a reduction of $1.8 million, or approximately 36 percent. The comparative 2017 quarter included a non-cash gain of $3.8 million on the fair value adjustment of warrant derivative liabilities related to warrants issued in 2016, compared to no gain during the current third quarter related to these now expired warrants.

Research and development (R&D) expenses were $0.9 million for the third quarter of 2018, which represents primarily expenses for the development of the albumin companion diagnostic (ACDx). In the third quarter of 2017, R&D expenses of $4.8 million included $3.7 million related to our aldoxorubicin program and its clinical support and $1.0 million for pre-clinical development of new albumin-binding, ultra-high potency cancer drugs.

General and administrative (G&A) expenses were $2.4 million for the third quarter of 2018, compared with $3.4 million for the third quarter of 2017. G&A expenses decreased by approximately 31 percent primarily due to a decrease in professional fees.

Based on our currently projected expenditures for the next 13 months our monthly burn rate is estimated at approximately $700,000 per month.

Conference Call and Webcast

CytRx will be hosting a conference call and webcast today beginning at 11:00 am Eastern Time (8:00 am Pacific Time). To access the conference call, dial (+1) 844-358-6753 (U.S. and Canada) or (+1) 216-562-0397 (international callers) and enter the conference ID number: 4382473. A live and archived webcast will be available in the News and Events/Events Calendar section of the Company’s website, www.cytrx.com. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial (+1) 855-859-2056 (U.S. and Canada) or (+1) 404-537-3406 (international callers) and enter the conference ID number: 4382473.

I-Mab and Genexine Announce China IND Approval for Innovative Immunotherapy

On November 2, 2018 I-MAB Biopharma Co., Ltd. ("I-Mab"), a Shanghai-based biotech company exclusively focused on innovative biologics in immuno-oncology and autoimmune diseases, and Genexine Inc. (KOSDAQ: 095700), a South Korea-listed clinical stage pharma company developing innovative biologics, jointly reported that China National Medical Products Administration (NMPA) has officially approved the Investigational New Drug (IND) application for TJ107 (HyLeukin), the first and only long-acting recombinant human interleukin-7 (rhIL-7) globally to treat chemotherapy induced lymphopenia and cancer (Press release, I-Mab Biopharma, NOV 2, 2018, View Source [SID1234530691]).

"We are pleased that the NMPA has given their greenlight to the IND filing, which is another significant development milestone in advancing our China Portfolio," said Joan Shen, M.D., Ph.D., President of R&D at I-Mab. "The clinical potential of TJ107 (HyLeukin) has been recognized and endorsed by the regulatory authorities, since there is no approved treatment globally for lymphopenia, the unmet medical need is substantial."

TJ107 (HyLeukin) is an immuno-oncology agent comprised of an optimally engineered interleukin-7 (IL-7) molecule based on Genexine’s proprietary hybrid Fc (hyFc) technology for half-life extension, with improved stability and developability. I-Mab has development and commercialization rights to TJ107 (HyLeukin) in Greater China through an exclusive licensing agreement with Genexine in December 2017.

"The IND approval in China for Hyleukin-7 clinical trial is a very important progress in its development and the data generated from the study in cancer patients with lymphopenia will significantly contribute to the global development of Hyleukin-7 as an antitumor immunotherapeutic," commented by Kyudon Kim, Ph.D., President at Genexine, Inc..

"Our long term goal is to develop TJ107 into a potential global first-in-class immuno-oncology therapy," Shen added