SLC-0111 is a first-in-class small molecule which selectively inhibits Carbonic Anhydrase IX (CAIX) (Company Web Page, Welichem Biotech, MAR 30, 2018, View Source [SID1234525068]). It has been in phase I clinical trials in multi-centers in Canada to establish a maximum tolerable dose and pharmacokinetics in cancer patients since October 2014. The completion of the study is anticipated by Q3 2016. SLC has entered into a partnership to develop this compound with Welichem Biotech Inc.

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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.
————————————-
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.

On March 29, OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported that it will release its financial and operating results for the fourth quarter and full year 2017, ended December 31, 2017, on Monday, April 2, 2018, after the close of the U.S. financial markets (Press release, Oncocyte, MAR 29, 2018, View Source;p=RssLanding&cat=news&id=2340277 [SID1234525059]). The Company will host a conference call on Monday, April 2, 2018, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results along with recent corporate developments.

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The dial-in number in the U.S./Canada is 800-281-7973, for international participants the number is 323-794-2093. For all callers, refer to Conference ID 4101947. To access the live webcast, go to the investor relations section on the company’s website, View Source A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial 719-457-0820. Use the Conference ID 4101947. Additionally, the archived webcast will be available at View Source

On March 29, 2018 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients, reported financial results for the fourth quarter and year ended December 31, 2017 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, CASI Pharmaceuticals, MAR 29, 2018, View Source [SID1234525060]).

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Wei-Wu He, Ph.D., Executive Chairman of CASI Pharmaceuticals, commented, "2017 was an exciting year for CASI and we have entered 2018 with the same strong momentum. We raised $50 million from new and existing investors, which leaves us well-positioned to launch EVOMELA after the CFDA’s priority review is concluded."

Dr. He continued, "We are incredibly excited by our recent acquisition of a portfolio of ANDAs from Sandoz. We saw an opportunity to acquire medicines already approved in the U.S. and delivering them to the large patient population in China seeking high quality medicines from abroad. We think this is an important new direction for the company and allows CASI the opportunity to commercialize a greater number of both high quality and innovative medicines to Chinese patients. We will prioritize the order in which we plan to introduce these medicines based on the commercial opportunity each present and intend to tap into our local networks and potential partners to accelerate commercialization and market penetration. The rapid change and improvement of the regulatory environment in China for drug development coincides with our strategic mission in both the U.S. and China. Going forward, we plan to leverage our development, regulatory, and commercial infrastructure in China by continuing to add safe and effective medicines to our pipeline."

CASI Pharmaceuticals, Inc. / 9620 Medical Center Drive / Suite 300 / Rockville, MD 20850

Phone 240.864.2600 / Fax 301.315.2437

Full Year and Recent Business Highlights

·Announced $50 million private placement to new and existing investors – In March 2018, the Company announced a $50 million private placement led by existing shareholders, ETP Global Fund LP and IDG-Accel China. Robert W. Duggan, former Chairman and CEO of Pharmacyclics Inc. participated as a new investor in CASI. The Company had previously closed on a $23.8 million registered direct offering in October 2017.

·Acquired portfolio of 25 US FDA-approved ANDAs from Sandoz Inc. – In January 2018, the Company announced the acquisition of a portfolio of 25 US FDA-approved ANDAs, and one that the FDA tentatively approved and three that are pending FDA approval. CASI intends to select and commercialize certain products from the portfolio that it believes have a unique market opportunity and can be manufactured cost-effectively in China and/or in the U.S.

·EVOMELA granted priority review by the CFDA; MARQIBO and ZEVALIN CFDA review in progress – In September 2017, the Company announced that the CFDA granted priority review for CASI’s import drug registration clinical trial application (CTA) for EVOMELA (melphalan) for injection. The CFDA cited the following reasons as grounds for granting priority review (1) multiple myeloma is a rare disease, (2) there is no melphalan in any formulation available in China to address the unmet medical need, and (3) EVOMELA has clear therapeutic advantages to currently available therapeutics. The CFDA review of CTAs for both MARQIBO and ZEVALIN is underway and progressing on schedule.

Financial Results for the Year ended December 31, 2017

Cash Position: As of December 31, 2017, CASI had cash and cash equivalents of approximately $43.5 million.

R&D Expenses: Research and development (R&D) expenses for the year ended December 31, 2017 were $7.6 million compared to $4.6 million in 2016, an increase of $3.0 million. The increase in 2017 R&D spending primarily reflects $2.8 million in higher costs associated with the quality testing phase of the CFDA regulatory review of ZEVALIN and EVOMELA in 2017, as well as $0.2 million in additional personnel costs related to our preclinical activities in China.

G&A Expenses: General and administrative (G&A) expenses for the year ended December 31, 2017 were $3.2 million compared to $4.8 million in 2016. The increase of $1.6 million in G&A over the prior year primarily reflects an increase of $1.8 million in non-cash stock compensation offset by a $0.2 million increase in additional personnel costs related to business development activities.

Net Loss: The net loss for the year ended December 31, 2017 was ($10.8 million), or ($0.18) per share, compared with a net loss of ($9.5 million) or ($0.17) per share in 2016. The larger net loss in 2017 can be attributed to costs associated with CFDA quality testing in support of CASI’s application for import drug registration of ZEVALIN and EVOMELA, offset by less non-cash stock compensation expense during 2017.

Financial Results for the Quarter ended December 31, 2017

R&D Expenses: R&D expenses for the quarter ended December 31, 2017 were $3.8 million compared to $1.3 million in 2016, an increase of $2.5 million. The increase in R&D expenses primarily reflects continued investment in CASI’s development of approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. in China.

G&A Expenses: G&A expenses for the quarter ended December 31, 2017 were $1.2 million compared to $1.4 million in 2016. The decrease in G&A over the prior year primarily reflects the decrease in non-cash stock compensation expense offset by increases due to additional personnel within our business development function and higher professional fees. G&A expenses include non-cash share-based compensation of $0.1 million in the fourth quarter 2017 compared to $0.6 million in the fourth quarter 2016.

Net Loss: The Company reported a net loss of ($5.0 million), or ($0.08) per share, for the quarter ended December 31, 2017. This compares with a net loss of ($2.7 million), or ($0.05) per share for the fourth quarter of 2016. The increase in net loss is primarily due to costs associated with CFDA quality testing in support of CASI’s application for import drug registration of ZEVALIN.

Further information regarding the Company, including its Annual Report on Form 10-K for the year ended December 31, 2017, can be found at www.casipharmaceuticals.com.