On May 10, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported financial results for the first quarter of 2019 ended March 31, 2019, and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, MAY 10, 2019, View Source [SID1234536144]).

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”We are looking forward to reporting detailed data from the phase 1 single ascending dose study of PRS-060, an inhaled IL-4 receptor alpha antagonist for asthma, at the 2019 American Thoracic Society International Conference later this month,” said Stephen S. Yoder, President and CEO of Pieris. ”We are also looking forward to presenting data from the currently-enrolling phase 1 multiple ascending dose study of that candidate, including the drug’s FeNO-reducing potential versus placebo, at an upcoming medical meeting. Beyond PRS-060, we continue to advance multiple respiratory discovery programs, both proprietary and in collaboration with AstraZeneca, driving value across our expanding respiratory franchise. We also continue to make headway in our immuno-oncology programs. We plan to report comprehensive data from the phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors later this year. We also plan to report data from the phase 1 combination study of PRS-343 with atezolizumab later this year. Additionally, we expect to file an IND application for PRS-344, a PD-L1/4-1BB bispecific drug candidate we are co-developing with Servier, by year-end. We continue to work hard on execution over the last year and are pleased to be able to share the resulting fruits of our labor with our shareholders over the coming months.”

PRS-060: Pieris will present detailed data from the phase 1 single ascending dose study of PRS-060, an inhaled IL-4 receptor alpha antagonist for asthma, at the 2019 American Thoracic Society (ATS) International Conference later this month. The Company previously announced topline data from this study, reporting that PRS-060 was found to be safe and well-tolerated in healthy volunteers. Pieris also plans to present data from the multiple ascending dose phase 1 study of PRS-060 in patients with mild asthma and elevated levels of fractional exhaled nitric oxide (FeNO), a validated biomarker of lung inflammation, at an upcoming medical meeting. This study evaluates the safety, tolerability and FeNO-reducing potential of inhaled PRS-060 versus placebo. PRS-060 is the lead candidate in Pieris’ respiratory collaboration with AstraZeneca. Pieris is sponsoring the single and multiple ascending dose phase 1 studies and AstraZeneca is funding the costs. Assuming successful completion of the ongoing multiple ascending dose phase 1 study, AstraZeneca would sponsor and fund the phase 2a study. Upon completion of that study, Pieris may exercise options to co-develop and, later, co-commercialize PRS-060.
Respiratory Pipeline: Pieris continues to advance two discovery-stage programs as part of its respiratory alliance with AstraZeneca, under which AstraZeneca may initiate up to two additional programs. The Company also continues to advance the two proprietary discovery-stage respiratory programs initiated last year and intends to initiate additional proprietary respiratory programs in 2019.
PRS-343: Pieris continues to enroll and treat patients in a phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, and intends to report comprehensive data from the study later this year. The Company also continues to enroll the dose-escalation phase 1 study of PRS-343 in combination with atezolizumab and intends to report data from this trial later this year.

Immuno-Oncology Pipeline: Pieris plans to file an IND application for PRS-344, a 4-1BB/PD-L1 bispecific the Company is developing as part of its immuno-oncology collaboration with Servier, later this year.
PRS-080: Pieris will present data from the phase 2a study of PRS-080, a half-life-optimized hepcidin antagonist for anemia, at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Congress on June 16, 2019.
First Quarter Financial Update:

Cash Position – Cash, cash equivalents and investments totaled $110.8 million as of March 31, 2019, compared to a cash, cash equivalents and investments balance of $128.1 million as of December 31, 2018. The decrease was due to operating cash expense, annual bonus payments, and timing of receivables collection from our strategic partners.

R&D Expense – R&D expenses were $14.3 million for the three months ended March 31, 2019, compared to $7.9 million for the three months ended March 31, 2018. The increase in research and development expenses reflects increases in clinical, drug supply and manufacturing, and salaries and benefit costs associated with the advancement of our clinical and preclinical programs.

G&A Expense – G&A expenses were $4.9 million for the three months ended March 31, 2019, compared to $4.4 million for the three months ended March 31, 2018. The increase in G&A expenses reflects higher personnel costs and audit and tax professional fees.

Interest Income – Interest income was $0.5 million for the three months ended March 31, 2019, compared to $0.3 million in interest income earned in the comparable 2018 period. The Company earned higher rates of interest despite having lower overall investment amounts compared to the first quarter of 2018.

Other Expense – Other expense was $0.2 million for the three months ended March 31, 2019, compared to other expense of $0.9 million for the three months ended March 31, 2018. The decrease in other expense was the result of a strengthening of the U.S. dollar against the euro, positively impacting the remeasurement of U.S. dollar denominated monetary assets held in Germany, combined with lower foreign denominated balances.

Net Loss – Net loss was $10.3 million or $(0.20) per share for the three months ended March 31, 2019, compared to a net loss of $8.7 million or $(0.17) per share for the three months ended March 31, 2018.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM Eastern Daylight Time on Friday, May 10, 2019, to provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.

On May 10, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported financial results and business highlights for the first quarter ended March 31, 2019 (Press release, Stemline Therapeutics, MAY 10, 2019, View Source [SID1234536138]).

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"Since ELZONRIS became commercially available in January, we have been very pleased with the progress we have made executing our launch plan," stated Robert Francomano, SVP and Global Head of Commercial. "Our entire organization is working hard to ensure patients with BPDCN have access to ELZONRIS. Although still early, we believe the launch is progressing extremely well and remain poised for a very successful 2019 and beyond."

Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented "We have built a solid foundation for growth, driven by our launch of ELZONRIS for patients with BPDCN. We are executing our commercial plan, including pursuing ongoing efforts to unlock additional value from ELZONRIS in other indications as well as from our entire pipeline, all with the goal of improving the lives of patients with cancer around the world."

First Quarter 2019 Financial Results Review

Net revenue for ELZONRIS was $5.05 million for the quarter ended March 31, 2019. Stemline began commercial sales of ELZONRIS within the United States in January 2019.

Stemline ended the first quarter with $124.4 million in cash, cash equivalents and investments. For the first quarter, Stemline had a net loss of $27.4 million. Cash expenditures for the first quarter of 2019 was $21.9 million.

Research and development expenses were $17.0 million for the first quarter of 2019, which reflects an increase of $4.3 million compared with $12.7 million for the first quarter of 2018. The higher cost was primarily driven by expense recorded related to repayment of research funding as a result of the first commercial sale of ELZONRIS.

Selling, general and administrative expenses were $16.0 million for the first quarter of 2019, which reflects an increase of $10.1 million compared with $5.9 million for the first quarter of 2018. The increase in costs were primarily attributable to launch expenses in support of the commercialization of ELZONRIS.

Recent Corporate Developments and Program Highlights

ELZONRIS (tagraxofusp) — Blastic plasmacytoid dendritic cell neoplasm (BPDCN)

· ELZONRIS was approved by the FDA on December 21, 2018 and commercially available for patients with BPDCN in the U.S. in January 2019.

· The New England Journal of Medicine published the pivotal trial results in its April 25th edition.

· We submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in January 2019 seeking marketing approval in Europe. The MAA was granted accelerated assessment and is currently under review.

ELZONRIS — Market Expansion Efforts

· We are conducting clinical trials to evaluate ELZONRIS in additional indications, including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

· Based on clinical results observed in patients with CMML and MF, we are evaluating next steps, including potential registrational pathways. For CMML, we intend to provide our registration-directed plans mid-year.

·We are also evaluating additional expansion opportunities, including maintenance therapy after stem cell transplant in patients with BPDCN.

· In parallel, we plan to expand our clinical efforts later this year and next into subsets of AML patients, including those enriched for CD123+ expression.

· We expect to provide periodic updates on these programs throughout this year and next at scientific conferences.

ASCO Conference

· ELZONRIS clinical trial data in CMML and MF have been selected for two poster presentations at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference in June.

Other pipeline candidates

·We expect to provide periodic updates on our other product candidates, SL-701, SL-801, SL-901, and SL-1001, later this year.

Conference Call Information

Stemline will host a conference call and live webcast today at 8:00 a.m. ET to discuss first quarter 2019 financial results and recent business activities. 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 (MAA) 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 9, 2019 Sofinnova Partners, a leading European venture capital firm specialized in the life sciences, reported that the firm led Twentyeight-Seven Therapeutics, Inc’s [28-7] Series A extension with a $15 million investment (Press release, Twentyeight-Seven Therapeutics, MAY 9, 2019, View Source [SID1234638814]). In addition to Sofinnova Partners, Osage University Partners (OUP) participated in the Series A extension bringing the total Series A financing to $82.75 million. Sofinnova Partners and OUP join the initial 28-7 investors that include MPM Capital, Novartis Venture Fund, Johnson & Johnson Innovation – JJDC, Inc., Vertex Ventures HC, Longwood Fund and Astellas Venture Management.

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"Sofinnova Partners is known for being a company-builder, with a strong focus on teams and science. With Sofinnova’s participation, we are able to work on proteins that regulate additional classes of RNA, including mRNA, as well as to leverage the programs into indications outside of oncology"

"Sofinnova Partners views 28-7 as the clear leader in capitalizing on the emerging science around RNA biology and how its dysregulation contributes to many serious diseases such as cancer," said Henrijette Richter, Ph.D., Managing Partner at Sofinnova Partners. "We were captivated by the Company with its strong team of serial entrepreneurs possessing an incredible track record of successes, an exceptional group of academic founders, and the impressive scientific data and drug discovery progress around their lead RNA-focused program. They are developing game-changing therapeutics to treat cancers with high unmet need. We are therefore thrilled to be joining 28-7 early in the Company’s progress and to be investing in their exciting pipeline." Dr. Richter will join the Company’s Board of Directors.

Since the close of the initial $65M Series A announced in September 2018, 28-7 has moved into its new facilities in Watertown, MA. Kazumi Shiosaki, Ph.D., CEO of 28-7, noted that the additional investment by Sofinnova Partners allows the Company to accelerate its current programs, build out its technology platform and expand into additional opportunities. "Sofinnova Partners is known for being a company-builder, with a strong focus on teams and science. With Sofinnova’s participation, we are able to work on proteins that regulate additional classes of RNA, including mRNA, as well as to leverage the programs into indications outside of oncology," said Dr. Shiosaki.

28-7’s technology does not directly target small-molecules to the RNA itself but rather targets RNA-modulating proteins (RMPs). The lead program focuses on regulating levels of let-7, an important micro RNA (miRNA) that suppresses the translation of major oncogenes, whose levels can be disrupted by a protein called LIN28. In certain cancers, LIN28 is re-expressed and its binding of the let-7 precursor prevents the production of mature let-7 needed to maintain oncogene suppression. The Company’s lead program is developing small molecules that prevent the binding of let-7 precursor to LIN28 and restore the beneficial levels of mature let-7.

On May 9, 2019 Probiodrug AG (Euronext Amsterdam: PBD, ISIN: DE0007921835), is focusing on the discovery and development of drugs acting on enzymes which are modulating the activity of cellular signalling pathways connected to human disease, reported that it will publish its first quarter business update for the period ended March 31, 2019 on Thursday, May 16, 2019, in the form of an interim management report (Press release, Vivoryon Therapeutics, MAY 9, 2019, View Source [SID1234537419]).

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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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For more information, please contact:

Probiodrug
Dr. Ulrich Dauer, CEO
Email: [email protected]

MC Services AG
Anne Hennecke, Susanne Kutter
Tel: +49 (0) 211 529 252 27
Email: [email protected]

On May 9, 2019 EnGeneIC Limited, a clinical-stage biopharmaceutical company advancing its proprietary EDV nanocell platform for targeted cyto-immunotherapy in cancer, reported that the first four patients have been dosed in a Phase I/IIa study using the Company’s tumor-targeting, immunogenic EDVs to deliver a cytotoxic drug payload directly to tumors of patients who have exhausted curative treatment options (Press release, EnGeneIC, MAY 9, 2019, View Source [SID1234536197]). The study is enrolling patients with advanced pancreatic cancer and other EGFR-expressing solid tumors in a second cohort, which is currently underway at Frankston Private Hospital in Victoria, Australia, with Professor Vinod Ganju, MBBS, FRACP, as the Principal Investigator.

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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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EnGeneIC’s second-generation EDV nanocells deliver an extremely cytotoxic nemorubicin derivative (D682) directly to solid tumors via EGFR targeting on the tumor cell surface, keeping healthy tissue protected from damage. The novel therapy also includes EDVs carrying an immune-boosting adjuvant to further augment the anti-tumor immune response stimulated by the bacterially-derived EDVs and perpetuated by tumor cell destruction.

Jennifer MacDiarmid, Ph.D., and Himanshu Brahmbhatt, Ph.D., joint-CEOs and Directors of EnGeneIC, stated, "We developed our second-generation EDVs to address multi-drug resistance in patients who have failed multiple lines of chemotherapy and therefore have the highest unmet need. D682 is an extremely potent drug that is far too toxic to be delivered systemically, but has proven safe in patients when encapsulated in our EDVs. We have named the study, the Carolyn Trial, after a close friend who had end-stage pancreatic cancer and was treated in a compassionate use case study. Carolyn was the first patient in the world to receive D682, and we observed highly encouraging results. Not only was survival extended, but quality of life improved considerably for the patient. Moreover, there was significant evidence of tumor regression coincident with a decrease in a key pancreatic cancer blood marker and a robust increase in anti-tumor CD8+ T cells and other anti-tumor immune cells. We are now executing a more rigorous clinical trial, not only for pancreatic cancer patients, but also for other advanced-stage patients with drug-refractory tumors."

Professor Ganju commented "Novel therapies for these late stage patients with drug-resistant tumors are desperately needed. Four patients have been enrolled on the study and so far we have been impressed with the tolerability and safety of this therapy. We will be getting some efficacy data in coming months."

About the Phase 1/2a Study

The two-cohort study will enroll up to 40 evaluable patients per cohort: 1) patients with advanced pancreatic cancer and 2) patients with EGFR-expressing solid tumors who have failed first- and second-line therapy or for whom standard therapies are not appropriate. The test article is EnGeneIC’s second-generation EGFR-targeted, D682-carrying EDV (EEDVD682) plus EDVs carrying an immune adjuvant (EDVadj) which acts to augment the anti-tumor immunity. Study objectives include assessing the safety and tolerability of EEDVD682 plus EDVadj, assessing anti-tumor response and overall survival. Exploratory objectives include biomarker assessment for immune response such as cellular immune response (CD8+ T cells, NK cells), and activated dendritic cells. In addition to the current clinical site, the study is expected to be opened in at least one other major cancer center in Sydney, Australia. For more information visit View Source;isReview=true