On March 30, 2018 – NANOBIOTIX (Euronext: NANO – ISIN:
FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer,reported its audited consolidated results for the fiscal year ended December 31, 2017 (Press release, Nanobiotix, 30 30, 2018, View Source [SID1234525073]):

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Expansion of the Nanobiotix clinical development program activities – seven clinical trials running in eight
indications on 3 continents – in relation to the market access of NBTXR3, Nanobiotix’s lead product, have
impacted operating expenses as planned.

Continuation of the structuration of the Company: several recruitments, notably within the Medical Affairdepartment, opening of 2 affiliates in Europe and preparation of a new manufacturing site.

Consolidation of the cash available at €47.2M strengthened by the completion of two private placements
executed in April and October 2017.

The audited consolidated financial statements for the fiscal year ended December 31, 2017 have been approved by the
management board and reviewed by the supervisory board of the Company dated on March 29, 2018.

Financial statements have been audited

Financial Review

Total Revenue in 2017 amounts to €3.7M vs. €5.4M in 2016, in line with our operational development expectations,
mainly due to:

Revenues from PharmaEngine amounting to €252K (vs. €1,558K in 2016), generated by the recharge of goods
and services provided related to activities planned as per the partnership convention with PharmaEngine; and Other revenues of €3,469K (vs. €3,864K in 2016) mainly related to the Research Tax Credit (CIR), moving in line with the level of R&D activities

Total Operating expenses reach €28.7M in 2017 vs. €27.3M in 2016:

R&D expenses in 2017 were €16.3M, lower than 2016 R&D costs by -€ 0.6M, due to lower clinical development costs as per fluctuation in patient recruitment phases during the year, as well as lower research costs. This decrease is offset by the increase in R&D headcount in the U.S. subsidiary.

SG&A costs reached €9.7M (+€1.4M ), mainly due to some changes in the structure (creation of the COO position in February 2017), and the increase of headcount, as well as consulting fees, hiring fees and communication costs in accordance with the group’s growth strategy.

Share based payment-related costs were €2.6M in 2017 (vs. €2.0M in 2016), being the result of an accounting treatment (having no cash impact)

Total consolidated headcount reached 85 as of December 31, 2017 vs. 67 in 2016, in line with the company’s growth.

Net loss after tax amounts to €26.1M (vs. €21.9M (loss) in 2016), in line with operational development expectations.
Cash available at December 31, 2017 amounts to €47.2M.

In April, the Company completed a private placement of €25.1M providing additional resources to support the group’s development. This operation has been an opportunity for Nanobiotix’s institutional shareholders to reinforce their position and to welcome new shareholders from U.S. and EU.

In October, Nanobiotix successfully completed an approximately €27.2M placement of new shares. This operation
opened the opportunity for Nanobiotix to welcome new investors specialized in life sciences and biotechnology mainly
from the U.S. and from Europe.

The cumulated amount of money raised in 2017 is about €52.3M.
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Nanobiotix activities and achievements in 2017
– Reported positive interim phase I/II data withNBTXR3 in Head & Neck cancer / ASCO (Free ASCO Whitepaper)
– Interim readout and completion of recruitment in phase II/III withNBTXR3 in Soft Tissue Sarcoma
– Advanced phase I/II in HCC/liver metastasis
– Initiated phase I/II in prostate cancer under company IND
– Reported positive IO biomarker study data in STS patients / SITC (Free SITC Whitepaper)
– IND granted to start phase I/II combination study with checkpoint inhibitors
– Company buildout and expansion with the addition of Chief Operating Officer and establishment of European
Operations

2018 perspectives

NBTXR3 is now 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 use of Nanobiotix’s NBTXR3 in this population aims to provide better local and systemic disease and prolongs survival with the improvement of Quality of Life.

Given the very promising Phase I/II trial results presented at ASCO (Free ASCO Whitepaper) 2017, Nanobiotix has filed a protocol amendment to expand the study to more patients in order to confirm the efficacy of NBTXR3. Nanobiotix is also planning to open 12-15 additional clinical trial sites in Europe and to expand this study to the U.S. at a later stage.

This indication is critical to establish the medical value of the product regarding the local control of the tumors, the
potential metastatic control through in situ vaccination, and its rare safety profile.

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 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.

Many IO combination strategies focus on ‘priming’ the tumor, which is now becoming a prerequisite for turning a "cold" tumor into a "hot" tumor. Compared to other products that could be used for priming the tumor, NBTXR3 could have a number of advantages: it is a physical and universal mode of action that could be used widely across oncology; it involves a one-time local injection; it is a good fit within existing medical practice already used as a basis for cancer treatment; it has a very good chronic safety profile and a well-established manufacturing process.

Nanobiotix is focusing on delivering new clinical and pre-clinical data confirming that NBTXR3 could play a key role in oncology and could become a backbone in immuno-oncology.

The Company expects to present the results of its Phase II/III trial of NBTXR3 in soft tissue sarcoma in Q2 2018.

In December 2017, regarding the technical file, LNE/G-MED informed Nanobiotix at this time they would need a few more months to finalize the evaluation required for CE marking for soft tissue sarcoma (STS).

Nanobiotix is also running multiple Phase I/II trials in order to widen the usage of the product.

2018 should be another year of growth for Nanobiotix with various milestones:

First patient recruitment in Phase I/II clinical trial in the U.S. looking at the potential of NBTXR3 to transform anti-PD1 non-responders into responders. The multi-arm trial will include recurrent and/or metastatic lung, and head & neck cancer patients

 Presentation of the results of Phase II/III STS, when the analysis is complete
 First market approval in Europe (CE Marking)
 Interim update from Phase I/II head and neck cancer trial with high risk elderly patients
 Additional news on other clinical trials and programs

On March 30, 2018 Radius Health, Inc. (Nasdaq:RDUS) announced today that the company has initiated the Phase 3 ATOM (Abaloparatide Treatment for Osteoporosis in Males) study of abaloparatide injection for the treatment of osteoporosis in men (Press release, Radius, MAR 30, 2018, View Source [SID1234525074]).

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"Approximately 20 percent of men over the age of 50 years will sustain an osteoporotic-related fracture in their lifetime attributed to multiple risk factors. If successful, this study will serve as the basis of a supplemental New Drug Application (sNDA) seeking to expand the use of abaloparatide to treat men with osteoporosis at high risk for fracture," said Gary Hattersley, PhD, Chief Scientific Officer of Radius Health. "The study will also include specialized high-resolution imaging to examine the effect of abaloparatide on bone structure, such as the hip, in a subset of the study participants."

The primary endpoint of the male osteoporosis study is change in lumbar spine bone mineral density (BMD) at 12 months compared with placebo. The randomized, double-blind, placebo-controlled trial will enroll approximately 225 men with osteoporosis.

"Radius’ strategy is to continue to expand the abaloparatide label and innovate on the mechanism of delivery, via our investigational abaloparatide patch, to position the Company as the market leader in osteoporosis," said Jesper Høiland, President and Chief Executive Officer. "As males represent approximately 10 percent of the total treated osteoporotic patient population, it is important to explore new treatment options for this group of patients."

Abaloparatide, marketed as TYMLOS in the United States, was approved in April 2017 by the US Food and Drug Administration (FDA) for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF OSTEOSARCOMA

Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80 mcg dose. It is unknown if TYMLOS will cause osteosarcoma in humans.
The use of TYMLOS is not recommended in patients at increased risk of osteosarcoma including those with Paget’s disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external beam or implant radiation therapy involving the skeleton.
Cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended.
Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary.

Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia.

Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.

Adverse Reactions: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain and vertigo.

INDICATIONS AND USAGE

TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures.

Limitations of Use

Because of the unknown relevance of the rodent osteosarcoma findings to humans, cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended.

For the TYMLOS prescribing information, including Boxed Warning, please visit www.tymlospi.com.

About TYMLOS (abaloparatide) injection

TYMLOS (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Radius also is developing abaloparatide patch based on 3M’s patented Microstructured Transdermal System technology for potential use as a treatment for postmenopausal women with osteoporosis.

(Filing, Annual, Nymox, 2017, MAR 30, 2018, View Source [SID1234525069])

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On March 29, 2018 Institut Curie and Freenome reported a strategic collaboration to evaluate Freenome’s artificial intelligence (AI) genomics platform as a novel tool to predict patient response to immuno-oncology therapies by observing changes in circulating cell-free biomarkers (Press release, Institut Curie, 29 29, 2018, View Source [SID1234525067]).

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In recent years so-called liquid biopsies have established the possibility of detecting circulating fragments of tumor DNA (ctDNA) and circulating tumor cells (CTCs) in the blood of patients with cancer. Institut Curie has been a pioneer in the field since the late 90’s with the first program on disseminated tumor cell (DTC) detection in the bone marrow of patients with early breast cancer. Since then, Institut Curie’s Circulating Tumor Biomarkers Laboratory has developed numerous innovative ctDNA techniques (ddPCR and NGS-based techniques).

Meanwhile, Freenome’s breakthrough use of machine learning looks beyond tumor DNA and processes the full range of cell-free (cf) biomarkers in the blood. By assembling an ever-expanding library of cell-free disease signatures, Freenome is developing a range of non-invasive blood tests for the early detection of cancer and early prediction of response to various oncology therapies. As a first step in this collaboration with Institut Curie, Freenome will analyze samples from the Analysis of Circulating Tumor Markers in the Blood (ALCINA) Trial, an umbrella trial allowing assessment of different circulating biomarkers and their correlation with clinical and pathological characteristics pertaining to response to PD-1 inhibitors alone and in combination with other therapies.

"Our machine learning scientists and molecular biologists are evaluating the cell-free genome – given 60-80%1,2,3 of cfDNA comes from immune cells – and other analytes. These provide a more complete picture of the dynamic interaction between the tumor and its environment," said Blandine Merino, VP of Business Development at Freenome. "Our approach incorporates a variety of biological signals, such as genomic, proteomic and epigenetic changes, providing new insights into possible mechanisms of resistance and guiding treatment selection for patients."

There is currently a high unmet need for biomarkers with high sensitivity and specificity for response prediction in immuno-oncology. The analysis of these data could open the way to new targets in precision oncology and improve therapeutic decision-making, particularly with the limitations associated with current approaches such as PD-L1 expression testing and assessing tumor mutational burden. Freenome’s tests would help to identify patients who are more likely to respond to PD-1 inhibitors; currently, approximately 80% of patients with advanced non-small-cell lung cancer, for example, do not respond to PD-1 inhibitors.4,5

According to Pr. François-Clement Bidard, Principal Investigator at Institut Curie, "Freenome is developing a novel approach which could revolutionize the way we analyze cell-free biomarkers for patients with cancer treated with immunotherapy; this approach complements a pipeline of innovative research projects that is ongoing at Institut Curie Circulating Tumor Biomarkers Laboratory."

Amaury Martin, Head of Institut Curie Technology Transfer and Industrial Partnerships Office and Director of the Institut Carnot Curie Cancer, added, "This agreement is one of the first at the Institut Curie with a company specializing in both cell free biomarkers and applying machine learning to large data sets. The Institut Curie MC21 strategic plan has identified innovation around liquid biopsy and big data as a major axis of medical-scientific research. With the arrival of a Data Director, Institut Curie, through its Carnot Institute, is determined to take a leading position in this key area for personalized medicine in oncology. The technologies developed by Freenome will fully benefit our patients and its access within the Institute will speed up future collaborations for developing and validating predictive tests."

About Freenome

Freenome is an AI genomics company on a mission to empower everyone with the tools they need to prevent, detect, and treat their diseases. By applying advanced machine learning techniques to recent breakthroughs in genomic science, Freenome is developing noninvasive blood tests to detect early-stage cancer and make treatments more effective. The company has raised $78 million from investors such as Andreessen Horowitz, Google Ventures, Polaris Partners, and Founders Fund.

For more information: View Source

On March 29, 2018 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results for the year ended December 31, 2017 (Press release, Galectin Therapeutics, MAR 29, 2018, View Source [SID1234525800]). These results are included in the Company’s Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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"In 2017 we achieve a major milestone in establishing GR-MD-02 as the first drug to show positive results in a clinical trial in patients with compensated NASH cirrhosis without esophageal varices," said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. "We believe this is the first randomized clinical trial of any drug to demonstrate clinically meaningful positive effects, including reducing portal hypertension, facilitating an improvement in liver cell death (a key component of NASH), and reducing the development of new esophageal varices, in this important group of patients. The drug has also always proven to be safe and well tolerated.

"In May 2018, we will be meeting with the Food and Drug Administration to present the results of our NASH-CX clinical trial. We hope to come to an agreement with the FDA on a plan for a Phase 3 clinical trial. In addition, we have submitted an application for Breakthrough Therapy Designation for GR-MD-02. We are also encouraged by the recent findings of a Phase 1 clinical trial of GR-MD-02 used in combination with pembrolizumab (KEYTRUDA) on melanoma patients, which may represent another path forward for GR-MD-02 into the significant market for evolving new cancer therapies. The positive results of the various trials conducted over the course of the past year have demonstrated that GR-MD-02 has potential in a variety of applications, from NASH to Immunotherapy and Skin Disease. In addition, through our strong intellectual property program, we are protecting the value of our asset and opening additional opportunities on a global basis. The management team at Galectin is dedicated to advancing our trials to unlock the full value of our potential."

Expected Upcoming Milestones

The Company will be meeting with the FDA in early May 2018 to present the results of its NASH-CX clinical trial. The purpose of the meeting is to seek agreement on a plan for a Phase 3 clinical trial

The Company has filed a request with the Food and Drug Administration to grant GR-MD-02 Breakthrough Therapy Designation as therapy for patients with NASH Cirrhosis without esophageal varices.

The Company has been selected to make an oral presentation at the International Liver Meeting in April 2018 in Paris. The presentation, which will be made by Dr. Naga Chalasani, one of the principal NASH-CX clinical trial investigators, is entitled, "A multicenter, randomized, double-blind, PLB-controlled trial of Galectin-3 inhibitor (GR-MD-02) in patients with NASH cirrhosis and portal hypertension."

The Company continues to remain in ongoing discussions with a number of pharmaceutical companies about potential partnerships.
Summary of Key Development Programs and Updates

The Company, in partnership with Providence Cancer Institute, presented preclinical and early clinical data from an investigator-initiated Phase 1 clinical trial of GR-MD-02 used in combination with pembrolizumab (KEYTRUDA). According to one of the principal investigators at the Providence Cancer Institute, the objective response rate of five out of eight patients (62.5%) in this trial with advanced melanoma, including two complete responses, is very encouraging and compares favorably with the known response rates with pembrolizumab alone (ORR of ~ 33%).

The company has begun enrolling cohort 3 (GR-MD-02 8 mg/kg), of the pembrolizumab, combination immunotherapy clinical trial, which will include at least 10 patients with melanoma, to provide a larger group of patients to evaluate. It is hoped additional data can be reported in mid-2018 when we anticipate a decision on progressing to phase 2.

The Company announced it has received two new patents in China and two new patents in Japan for the Company’s lead compound, GR-MD-02.

The Company announced it entered into a $10 million unsecured line of credit facility with stockholder and new director Richard E. Uihlein in December 2017.

Dr. Peter G. Traber, M.D., Chaired the Anti-Fibrotic Drug Development Summit 2017, which is dedicated to the translation of fibrotic mechanisms into clinically effective therapeutics.
Financial Results

For the year ended December 31, 2017, the Company reported a net loss applicable to common stockholders of $17.5 or $0.49 per share, compared to a net loss applicable to common stockholders of $22.4 million, or $0.76 per share, for 2016. The decrease is largely due to lower preclinical, clinical, legal, and stock-based compensation expenses.

Research and development expense for 2017 was $11.7 million, compared with $15.3 million, for 2016. The decrease primarily relates to a reduction in costs for the NASH-CX Phase 2 clinical trial as it winds down and lower preclinical costs.

General and administrative expense for 2017 was $4.5 million, compared to $6.2 million, for 2016, primarily due to a decrease in legal and stock-based compensation expenses.

As of December 31, 2017, the Company had $3.1 million of cash and cash equivalents. In December 2017, the Company entered into a $10 million line of credit and received $4.5 million in proceeds in January 2018 from common stock warrant exercises. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least March 31, 2019.

Positive Results in NASH Cirrhosis

GR-MD-02, a proprietary polysaccharide pharmaceutical preparation that inhibits galectin proteins, recently completed a Phase 2b clinical trial (NASH-CX). There were statistically significant and clinically relevant positive effects of GR-MD-02 on HVPG and other parameters in patients with NASH cirrhosis without esophageal varices following one year of therapy. Patients without esophageal varices comprise about 50 percent of the total population of patients

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with NASH cirrhosis, and is estimated to be 2.5 million people in the United States. This group of patients is readily diagnosed by endoscopy which is already part of the standard of care for patients with suspected NASH. The drug was well tolerated during this one-year trial. The Company believes that this is the first randomized clinical trial of any drug to demonstrate clinically meaningful positive effects in this important group of patients. Full details of Galectin’s NASH-CX trial can be found in a supplemental slide deck of our corporate presentation on the home page of our website.

Encouraging Results in Cancer Immunotherapy

GR-MD-02 also showed encouraging Phase 1b results in combination with pembrolizumab (KEYTRUDA) to treat advanced melanoma. In the first two cohorts of this study, five out of eight patients (62.5 percent) with advanced melanoma had objective responses, with two complete and three partial responses, which compares favorably with the known response rates with pembrolizumab alone (~33 percent). The study continues with additional results expected in Summer 2018. Full details on Galectin’s combination cancer immunotherapy program can be found in a supplemental slide deck to our corporate presentation on the home page of our website.