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Pieris Pharmaceuticals to Present at 43rd Annual Deutsche Bank Health Care Conference

On May 3, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that Louis Matis, Senior Vice President and Chief Development Officer of Pieris Pharmaceuticals, Inc., will present at the 43rd Annual Deutsche Bank Healthcare Conference on Tuesday, May 8, 2018 at 8:00AM EDT at the Intercontinental Boston Hotel in Boston, Massachusetts. A webcast of the company’s presentation will be available at this link (Press release, Pieris Pharmaceuticals, MAY 3, 2018, View Source [SID1234526085]).

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Onconova Therapeutics to Present at the Disruptive Growth and Healthcare Conference on May 8th, 2018

On May 3, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported that the Company will present and meet investors at the 2018 Disruptive Growth and Healthcare Conference in New York City (Press release, Onconova, MAY 3, 2018, View Source [SID1234526084]). Dr. Ramesh Kumar, President & CEO, will present at the event.

Details of the Presentation:

2018 Disruptive Growth and Healthcare Conference

Reed Smith
599 Lexington Avenue, 22nd Floor
New York, NY 10022

Presentation time: 5:05-5:25 PM EDT (breakout 5:30-05:50 PM)

Presentation room: A/B

The Company is available for investor and partnering meetings

NewLink Genetics Reports First Quarter 2018 Financial Results

On May 3, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported consolidated financial results for the first quarter 2018 and reviewed recent highlights and upcoming milestones (Press release, NewLink Genetics, MAY 3, 2018, View Source [SID1234526083]).

"NewLink Genetics continues to produce encouraging data supporting the differentiated mechanism of action of indoximod, its IDO pathway inhibitor, and the potential for indoximod in multiple therapeutic combinations to improve patient outcomes across a broad range of cancer indications," said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer.
Highlights

Abstracts accepted for presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting, June 2018

Abstract 4015 – Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine / nab-paclitaxel for the treatment of patients with metastatic pancreas cancer – to be presented during the discussion session, "Gastrointestinal (Noncolorectal) Cancer," Sunday, June 3, 2018, 4:45 PM – 6:00 PM CT

Abstract 9512 – Phase 2 trial of the IDO pathway inhibitor indoximod plus checkpoint inhibition for the treatment of patients with advanced melanoma – to be presented during the discussion session, "Melanoma/Skin Cancers," Monday, June 4, 2018, 4:45 PM – 6:00 PM CT

Abstracts presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 2018
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Abstract 3753 – Indoximod modulates AhR-driven transcription of genes that control immune function
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Abstract 10973 – Front-line therapy of DIPG using the IDO pathway inhibitor indoximod in combination with radiation and chemotherapy

Abstract, Radio-immunotherapy using the IDO pathway inhibitor indoximod for children with newly-diagnosed DIPG, to be presented at the 18th International Symposium on Pediatric Neuro-Oncology (ISPNO), Poster Session 1, Sunday, July 1, 2018, 5:00 PM – 6:30 PM MT

Data from Phase 1b trial of indoximod plus standard-of-care chemotherapy for patients with acute myeloid leukemia (AML) intended to be presented in the second half of 2018

Finalized the novel formulation of indoximod

Update on Clinical Programs and Financial Guidance
NewLink Genetics previously reported that it was undertaking a review of its clinical programs and determined it will not initiate its Phase 3 study of indoximod in combination with PD-1 inhibitors for patients with advanced melanoma. In addition, we have deprioritized pancreatic cancer and have mutually agreed with AstraZeneca not to proceed with the Phase 2 trial.
Clinical opportunities under consideration include high quality randomized studies of indoximod in one or more target disease states for which we have developed promising single-arm data over the last few years. Indoximod has demonstrated encouraging clinical data in a number of cancer indications including AML in combination with chemotherapy, DIPG in combination with radiation and chemotherapy, and melanoma in combination with checkpoint

Exhibit 99.1

blockade. When we complete the review of our clinical programs, we expect to have substantially reduced the rate at which the Company will be using cash. We intend to update our financial guidance when we report results for the second quarter.
Financial Results
Cash Position: NewLink Genetics ended the quarter on March 31, 2018, with cash and cash equivalents totaling $143.9 million compared to $158.7 million for the year ending December 31, 2017.
R&D Expenses: Research and development expenses for the three months ended March 31, 2018 were $20.3 million, an increase of $4.6 million from $15.7 million for the same period in 2017. The increase was due primarily to an increase of $8.4 million in contract research and manufacturing spend, an increase of $670,000 in clinical trial and legal and consulting expense, offset by a $2.1 million decrease in supplies, a $1.2 million decrease in personnel-related and stock compensation expense, and a $1.2 million decrease in licensing expenses.
G&A Expenses: General and administrative expenses for the three months ended March 31, 2018 were $8.3 million, an increase of $58,000 from $8.2 million for the same period in 2017. The increase was due to an increase of $733,000 of legal and consulting and other expense, offset by a decline of $675,000 in personnel-related and stock compensation.
Net Loss: The net loss for the three months ended March 31, 2018 was $18.3 million compared to net loss of $20.9 million for the same period in 2017. The basic and diluted weighted average common shares outstanding for the three months ended March 31, 2018 were 37,155,082, resulting in a basic and diluted loss per share of $0.49. For the three months ended March 31, 2017, the basic and diluted weighted average common shares outstanding were 29,213,488, resulting in basic and diluted loss per share of $0.72.
NewLink Genetics ended Q1 2018 with 37,165,098 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 the financial results and to review its clinical activities. NewLink Genetics’ senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.
Access to the live call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. The conference call will be webcast live and a link can be accessed through the NewLink Genetics website at View Source To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast. A replay of the call will be available for two weeks from the date of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 6768809.
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as AML, DIPG and melanoma.

NANOBIOTIX PARTNERS WITH WEILL CORNELL MEDICINE ON PRE-CLINICAL STUDIES
TO EVALUATE THE IMPACT OF NBTXR3 ON cGAS-STING PATHWAY IN MAMMARY CANCERS

On May 3, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported that it is launching a research collaboration with Weill Cornell Medicine to begin nonclinical studies of NBTXR3’s mechanism of action (Press release, Nanobiotix, MAY 3, 2018 View Source [SID1234526080]). NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy, tumors and metastasis through physical cell death and to induce immunogenic cell death leading to specific activation of the immune system.

The research collaboration between Weill Cornell Medicine, based in New York City, and Nanobiotix will be conducted
over the course of one year, with the goal of continuing the exploration of the role of NBTXR3 in Immuno-Oncology.
The main objective of this collaboration is to study the impact of NBTXR3 activated by radiotherapy on the cGAS-STING
pathway using different in vitro and in vivo murine models (mammary). Along with immunogenic cell death, the cGASSTING
pathway has emerged as the key component of the anti-tumor immune response. Data generated from this
collaboration could support current evidence indicating that NBTXR3 activated by radiotherapy can increase the antitumor
immune response, compared with radiotherapy alone, and transform an irradiated tumor into an efficient in
situ vaccine.
Dr. Sandra Demaria, M.D., Professor of Radiation Oncology and Chief of the Division of Experimental Radiotherapy in
the Department of Radiation Oncology at Weill Cornell Medicine, and Principal Investigator for the study, said: "We
have learned that radiotherapy has the potential to convert a tumor into an in-situ vaccine, and enhance systemic
tumor responses to immunotherapy. But there is room for improvement: NBTXR3 nanoparticles enhance the proimmunogenic
effects of radiotherapy, and we want to understand how they work. This knowledge will further the
development of this innovative approach for the treatment of cancer patients who are resistant to immune checkpoint
inhibitors."
The Company received the FDA’s approval to launch a clinical study of NBTXR3 activated by radiotherapy in
combination with anti-PD1 antibody in lung, and head and neck cancer patients (head and neck squamous cell
carcinoma and nonsmall cell lung cancer). This trial that shall start in Q2 2018, aims to expand the potential of NBTXR3,
including using it to treat recurrent or metastatic disease.
NBTXR3 positioning in IO
Many IO combination strategies focus on ‘priming’ the tumor, which is now becoming a prerequisite of turning a "cold"
tumor into a "hot" tumor.
Compared to other modalities that could be used for priming the tumor, NBTXR3 could have a number of advantages:
the physical and universal mode of action that could be used widely across oncology, a one-time local injection and
good fit within existing medical practice already used as a basis for cancer treatment, as well as a very good chronic
safety profile and well-established manufacturing process.
Published preclinical and clinical data indicate that NBTXR3 could play a key role in oncology and could become a
backbone in immuno-oncology.
Nanobiotix’s immuno-oncology combination program opens the door to new developments, potential new
indications, and important value creation opportunities.
-ends-
2
About NBTXR3
NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy, tumors and metastasis through physical
cell death and to immunogenic cell death leading to specific activation of the immune system.
NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment and
has the ability to fit into current worldwide standards of radiation care.
NBTXR3 is being evaluated in head and neck cancer (locally advanced squamous cell carcinoma of the oral cavity or oropharynx),
and the trial targets frail and elderly patients who have advanced cancer with very limited therapeutic options. The Phase I/II trial
has already delivered very promising results regarding the local control of the tumors and a potential metastatic control through
in situ vaccination.
Nanobiotix is running an Immuno-Oncology program with NBTXR3 that includes several studies. In the U.S., the Company received
the FDA’s approval to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibodies in lung,
and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer). This trial aims to
expand the potential of NBTXR3, including using it to treat recurrent or metastatic disease.
The first market authorization process (CE Marking) is ongoing in Europe in the soft tissue sarcoma indication.
The other ongoing studies are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced
or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent
chemotherapy, and prostate adenocarcinoma.

Moleculin Announces Engagement with Voisin Consulting Life Sciences to Expand Annamycin Clinical Trial

On May 3, 2018 Moleculin Biotech, Inc., (Nasdaq:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that it has engaged Voisin Consulting Life Sciences ("VCLS"), as an additional regulatory consulting firm and contract research organization ("CRO") to prepare for expansion of its clinical trial to study Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML") (Press release, Moleculin, MAY 3, 2018, View Source [SID1234526079]).

Moleculin engaged Voisin Consulting Life Sciences, headquartered in Paris, France to evaluate additional countries for the potential expansion of its AML clinical trial. VCLS is a multinational regulatory consulting firm and contract research organization with 150 life science professionals. The Moleculin engagement is intended to evaluate Australia and selected Western European countries to provide additional clinical sites.

"Now that our AML trial is underway, we are focused on expanding the opportunity for AML patients to participate in the trial," commented Walter Klemp, Moleculin’s Chairman and CEO. "Our strategy is to choose countries with the best possible balance between an efficient clinical trial authorization process, solid AML clinical trial experience and a population of qualified AML patients."

About Voisin Consulting Life Sciences

From discovery to product launch and life cycle management

AT Voisin Consulting Life Sciences (VCLS), regulatory science guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. Starting early in the process, from discovery to patient, VCLS assists innovators in designing optimized product development plans and regulatory strategies, combining the health ecosystem with commercial success. With a presence in seven locations across three continents and over 150 employees, VCLS serves a broad range of developers and their investors.

For more information, visit www.voisinconsulting.com