On May 8, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that the company will host a conference call and live webcast on Friday, May 10, 2019 at 8:00 a.m. ET to report its first quarter 2019 financial results and other business highlights (Press release, Stemline Therapeutics, MAY 8, 2019, https://ir.stemline.com/news-releases/news-release-details/stemline-therapeutics-host-conference-call-first-quarter-2019 [SID1234535922]).

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The conference call can be accessed by dialing 1-800-667-5617 (domestic) or 1-334-323-0509 (international) and referring to conference ID 2090827. The live webcast can be accessed via the company’s website (www.stemline.com), at the bottom of the "Investors & Media" section in the "News & Events" page. The webcast will be archived and made available for replay on the company’s website shortly after the event.

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MMA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

On May 8, 2019 Genmab reported that Interim Report for the First Quarter Ended March 31, 2019 (Press release, Genmab, MAY 8, 2019, View Source [SID1234535921])

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Highlights

Regulatory applications for daratumumab in combination with lenalidomide and dexamethasone based on the MAIA study in frontline multiple myeloma submitted in U.S. and Europe
Regulatory applications for daratumumab in combination with bortezomib, thalidomide and dexamethasone based on the CASSIOPEIA study in frontline multiple myeloma submitted in U.S. and Europe
Positive topline results from Phase III COLUMBA study of subcutaneous daratumumab for relapsed or refractory multiple myeloma
MorphoSys patent infringement complaint against Genmab and Janssen Biotech, Inc. dismissed, MorphoSys patents ruled invalid for lack of enablement, case ended
DARZALEX net sales increased 46% over Q1 2018 to USD 629 million, resulting in royalty income of DKK 502 million
"The first quarter was filled with regulatory news for DARZALEX, with our collaboration partner Janssen filing multiple new regulatory applications and achieving one new approval. In addition, we reported positive topline data for subcutaneous daratumumab in relapsed or refractory multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "During the first quarter we also continued to invest in and advance our innovative proprietary products under development using Genmab’s expertise in antibody drug development to create truly differentiated products to help cancer patients."

Financial Performance First Quarter of 2019

Revenue was DKK 591 million in the first quarter of 2019 compared to DKK 681 million in the first quarter of 2018. The decrease of DKK 90 million, or 13%, was mainly driven by the one-time payment from Novartis of USD 50 million (DKK 304 million) during the first quarter of 2018 for lost potential milestones and royalties following announcement of Novartis’ intention to transition Arzerra (ofatumumab) to limited availability via compassionate use programs for chronic lymphocytic leukemia (CLL) in non-US markets, partly offset by higher DARZALEX royalties and reimbursement income from our collaborations with Seattle Genetics and BioNTech.
Operating expenses were DKK 617 million in the first quarter of 2019 compared to DKK 357 million in the first quarter of 2018. The increase of DKK 260 million, or 73%, was driven by the advancement of enapotamab vedotin and tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support expansion of our product pipeline.
Operating loss was DKK 26 million in the first quarter of 2019 compared to operating income of DKK 324 million in the first quarter of 2018. As anticipated, the decrease of DKK 350 million, or 108%, was driven primarily by the one-time payment from Novartis in 2018 and increased operating expenses.
Outlook
Genmab is maintaining its 2019 financial guidance published on February 20, 2019.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2019 today, Wednesday, May 8, at 6.00 pm CEST, 5.00 pm BST or 12.00 pm EDT. To join the call dial
+1 631 510 7495 (US participants) or +44 2071 928000 (international participants) and provide conference code 8692103.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

Contact:
Marisol Peron, Corporate Vice President, Communications & Investor Relations
T: +1 609 524 0065; E: [email protected]
For Investor Relations:
Andrew Carlsen, Senior Director, Investor Relations
T: +45 3377 9558; E: [email protected]

On May 8, 2019 Cernostics, developer of next-generation cancer diagnostics and prognostics reported that the results of an independent study validating the use of its TissueCypher Barrett’s Esophagus Assay in determining the risk of progression to esophageal cancer (EC) in patients with Barrett’s esophagus (BE) will be presented during an oral session at Digestive Disease Week (DDW) 2019 (Press release, Cernostics, MAY 8, 2019, View Source [SID1234535920]).

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The study was conducted by clinicians at Cleveland Clinic and the University of Pittsburgh School of Medicine, in collaboration with Cernostics. DDW 2019, the world’s largest gathering of physicians, researchers and industry in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery, is taking place in San Diego, May 18 – 21, 2019.

"Independent validation of TissueCypher is an important milestone that provides physicians and patients additional confidence that this innovative approach can improve management of BE and reduce the risk of progression to EC," said Mike Hoerres, Cernostics’ CEO. "We look forward to the presentation of the results of this study, and believe they add to the growing body of evidence demonstrating that TissueCypher provides independent prognostic information for clinicians that cannot be attained by other methods. The TissueCypher platform uniquely evaluates protein expression of multiple biomarkers in the context of tissue structure of esophageal biopsies, and does so in a highly objective and quantitative manner."

Independent Validation of a Tissue Systems Pathology Test to Predict Progression in Barrett’s Esophagus Patients
Session Type: Clinical Symposium #1068
Session Title: Challenges and Controversies in Barrett’s Esophagus
Date: May 21, 2019 Time: 2:15 – 2:30 p.m. Location: SDCC Room 33ABC
DDW attendees are invited to attend the oral scientific session being presented by Rebecca Critchley-Thorne, Ph.D., Chief Scientific Officer at Cernostics.

About Barrett’s
BE affects more than three million Americans, occurring when chronic exposure to stomach acid causes the esophageal cell lining to deteriorate and undergo changes that can create an environment for cancer. Without treatment, Barrett’s can lead to EC, with a poor 5-year survival of less than 20%. Today, Barrett’s is commonly managed by surveillance, involving regular endoscopic procedures with biopsy, monitoring disease progression, and GERD-related drug therapy to control symptoms and prevent esophageal injury.

On May 8, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) reported financial results for the first quarter ended March 31, 2019 and provided an update on clinical activities (Press release, NewLink Genetics, MAY 8, 2019, View Source [SID1234535919]).

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"We continued to make progress across our clinical programs this year. We look forward to presenting additional encouraging data later this month on NLG802. We were also pleased to present Phase 2 results for NLG207 in combination with weekly paclitaxel for patients with recurrent ovarian cancer at AACR (Free AACR Whitepaper), which demonstrated an encouraging safety profile supporting the potential of NLG207 as a best-in-class topoisomerase 1 inhibitor for those women who had received multiple lines of therapy," said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer of NewLink Genetics. "With a strong cash position of $113.2 million at the end of the quarter, we are well positioned to continue moving our clinical programs forward, and we anticipate sharing additional data from our pipeline in the coming quarters as we prioritize clinical development programs with a focus on indications with high unmet need and a potential path forward to registration."

Clinical Update and Anticipated Upcoming Milestones

The Company has had an abstract accepted, and plans to present updated data from a Phase 1 dose-escalation study of NLG802, a prodrug of indoximod, at the Immuno-Oncology 2019 2nd World Congress in Barcelona, Spain, May 23-24, 2019.

The Phase 2 study of NLG207 (formerly CRLX101) in combination with weekly paclitaxel for patients with recurrent ovarian cancer, conducted in conjunction with The GOG Foundation, is complete. The Company recently presented results from this study at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, and we are evaluating NLG207 as a potential therapeutic in gynecologic malignancies.

Updated results from the cohort of patients with DIPG in the efficacy portion of a Phase 1b study of indoximod for the treatment of pediatric patients with recurrent malignant brain tumors are anticipated later in 2019.

In reference to NewLink Genetics’ partnered Ebola vaccine candidate, Merck recently announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for this vaccine, V920 (rVSV∆G-ZEBOV-GP). In addition, completion of the rolling Biologics License Application (BLA) filing with the FDA by Merck is anticipated in 2019. Should this vaccine be approved by the FDA, a Priority Review Voucher (PRV) would be issued, in which NewLink Genetics owns a substantial financial interest.

Financial Results for the Three-Month Period Ended March 31, 2019

Cash Position: NewLink Genetics ended the quarter on March 31, 2019, with cash and cash equivalents totaling $113.2 million compared to $120.7 millionDecember 31, 2018. The Company projects its cash position is sufficient to fund planned operations through the end of 2021.

R&D Expenses: Research and development expenses for the first quarter of 2019 were $5.2 million, a decrease of $15.1 million from $20.3 million for the same period in 2018. The decrease was primarily due to reductions of $9.9 million in contract research and manufacturing spend, $2.2 million in personnel-related and stock compensation expense, $2.1 million in clinical trial expense, $500,000 in supplies and licensing, and $400,000 in legal and consulting expense.

G&A Expenses: General and administrative expenses in the first quarter of 2019 were $5.6 million, a decrease of $2.7 million from $8.3 million for the same period in 2018. The decrease was due primarily to reductions of $2.1 million in personnel-related and stock compensation expense, $605,000 in legal and consulting expense, offset by an increase of $72,000 in supplies and travel expense.

Net Loss: NewLink Genetics reported a net loss of $10.0 million or ($0.27) per diluted share for the first quarter of 2019 compared to a net loss of $18.3 million or ($0.49) per diluted share for the first quarter of 2018.

NewLink Genetics ended Q1 2019 with 37,276,102 shares outstanding.

Conference Call and Webcast Details

The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss its financial results and to give an update on clinical and business development activities. There will also be a question and answer session following management’s prepared remarks.

Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) and using the conference ID 8457627. The conference call will be webcast live and a link to the webcast can be accessed through the NewLink Genetics website at www.NewLinkGenetics.com in the "Investors & Media" section under "Events and Presentations" or by clicking here. To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the conference ID 8457627. The replay will be available for two weeks from the date of the call.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target, suppressing immune response and allowing for immune escape by degrading tryptophan with the resultant production of kynurenine. Indoximod reverses the immunosuppressive effects of low tryptophan and high kynurenine through mechanisms that include modulation of the AhR-driven transcription of genes that control immune function. This results in increased proliferation of effector T cells, increased differentiation into helper T cells rather than regulatory T cells, and downregulation of IDO expression in dendritic cells. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications including DIPG, recurrent pediatric brain tumors, and AML.

About NLG802

NLG802 is an investigational, orally available prodrug of indoximod, a small molecule targeting the IDO Pathway. The IDO Pathway is one of the key immuno-oncology targets involved in regulating the tumor microenvironment and immune escape. NewLink Genetics is currently evaluating NLG802 in a Phase 1 dose-escalation clinical trial in cancer patients to assess the safety and pharmacokinetics of NLG802.

About NLG207

NLG207 (formerly CRLX101) is an investigational nanoparticle-drug conjugate (NDC) consisting of a cyclodextrin-based polymer backbone linked to camptothecin, a topoisomerase 1 inhibitor. NDCs enhance drug delivery to tumors where gradual payload release inside cancer cells augments antitumor activity while reducing toxicity. Topoisomerase 1 inhibitors are a class of drugs that modify DNA damage responses in cancer cells. NewLink Genetics is evaluating NLG207 in a series of clinical trials in advanced refractory ovarian cancer patients.

On May 8, 2019 Exicure, Inc. (OTCQB: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported financial results for the first quarter ended March 31, 2019 and provided an update on corporate progress (Press release, Exicure, MAY 8, 2019, View Source [SID1234535918]).

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"Exicure continues to drive our SNA technology into the clinic and expand our therapeutic areas of interest. In the first quarter of 2019, we opened four clinical sites and began enrolling patients in the Phase 1b/2 trial of AST-008 for patients with advanced or metastatic solid tumors including, Merkel cell carcinoma, melanoma, squamous carcinoma and squamous cell carcinoma of the head and neck," said Dr. David Giljohann, Chief Executive Officer of Exicure. "We are also pursuing significant unmet medical need in rare dermatological indications through our partnership with Dermelix and are expanding our platform in neurology."

Corporate Progress

Launched Phase 1b/2 clinical trial of AST-008—AST-008 is an SNA consisting of toll-like receptor 9, or TLR9, agonists designed for immuno-oncology applications.

Received authorization from the FDA for a Phase 1b/2 clinical trial of AST-008

Opened four clinical sites and began dosing patients

Expects to release results of the Phase 1b stage of this trial late in 2019

Entered into partnership with Dermelix for rare dermatological conditions—Dermelix will initially develop a targeted therapy for the treatment of Netherton Syndrome (NS) and Exicure is currently screening sequences against the target genes.

Presented a scientific poster at ARVO 2019—This poster showed that in a rat eye model, our SNAs distributed to both the back and the front of the eye, persisted in the eye longer than did conventional oligonucleotides, and did not cause inflammation. These data support the therapeutic potential of SNAs for treating retinal and corneal eye diseases.

Presented a scientific poster at AAN 2019—This poster demonstrated that SNAs containing the same sequence as the approved SMA drug nusinersen, delivered by intrathecal injection to rats, widely distributed throughout the CNS and persisted to a greater extent than did nusinersen. These data support the therapeutic potential of SNAs for treating CNS disorders.

First Quarter 2019 Financial Results and Financial Guidance

Cash Position: As of March 31, 2019, Exicure had cash and cash equivalents of $22.2 million compared to $26.3 million as of December 31, 2018.

Research and Development (R&D) Expenses: Research and development expenses were $3.4 million for the quarter ended March 31, 2019, compared to $3.3 million for the quarter ended March 31, 2018.

The increase in research and development expense of $0.1 million was primarily due to higher platform and discovery-related expense of $0.2 million and higher employee related expenses of $0.2 million, mostly offset by lower clinical development programs expense of $0.3 million.

General and Administrative (G&A) Expenses: General and administrative expenses were $2.2 million for the quarter ended March 31, 2019, compared to $2.0 million for the quarter ended March 31, 2018. The increase in general and administrative expenses of $0.2 million was primarily due higher compensation and travel expenses, partially offset by lower legal fees.

Net Loss: Net loss was $5.3 million for the quarter ended March 31, 2019, compared to net loss of $5.5 million for the quarter ended March 31, 2018. The $0.2 million reduction in net loss is due to the $0.5 million in other income attributable to the (non-cash) fair value adjustment of our common stock warrant liability, partially offset by the increase in operating expenses of $0.3 million as described above.

Cash Runway Guidance: Exicure believes that, based on its current operating plans and estimates of expenses, as of the date of this press release, its existing cash and cash equivalents as of March 31, 2019, will be sufficient to meet its anticipated cash requirements into early 2020.