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.
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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, InflaRx, 2017, MAR 29, 2018, View Source [SID1234527582])

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On March 29, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported financial results for the year ended December 31, 2017 (Press release, Altimmune, MAR 29, 2018, View Source [SID1234525052]).

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Corporate Highlights

Enrolled first two cohorts of government funded Phase 1 trial of NasoShield, an intranasal vaccine against anthrax infection

Positive data in two Phase 2 clinical programs:

Announced positive proof-of-concept Phase 2 flu vaccine trial results with our NasoVAX vaccine

Announced positive pre-clinical data from the Company’s SparVax-L trial comparing SparVax-L and BioThrax against anthrax infection

Extended its IP protection of NasoShield in the U.S. with a Notice of Allowance from the U.S. Patent Office

Elected Mitchel Sayare, Ph.D., as Chairman of its Board of Directors

Raised approximately $30 million in financing, including through a Series B preferred offering, cash acquired in connection with the reverse merger with PharmAthene and a pre-merger private placement with existing investors, providing cash into the first quarter of 2019
"We have had a very data-rich few weeks with results being reported from our NasoVAX, HepTcell, and SparVax-L programs and moving forward on enrollment in our Phase 1 trial of NasoShield," said William J. Enright, Chief Executive Officer of Altimmune. "We are very excited by the positive results from our NasoVAX trial and look forward to continuing to advance that program. NasoVAX is a very different type of flu vaccine that has tremendous potential as an effective, easy-to-use vaccine that potentially provides better protection than current vaccines. We are also excited by the results on our SparVax-L trial and look forward to moving that program forward once we secure additional government funding. We continue to evaluate our HepTcell results will update investors on our next steps as we better understand those results."

Mr. Enright continued, "operationally, we are pleased with our progress. In 2017 we closed the reverse merger with PharmAthene, allowing us to leverage our resources and create a focused immunotherapeutics company. We strengthened our scientific team with the promotion of Dr. Sybil Tasker to Chief Medical Officer in early 2017. Additionally, in January 2018, Mitchel Sayare, Ph.D. was elected as Chairman of our Board of Directors bringing in-depth biotechnology experience as the former CEO of Immunogen. We anticipate continuing to build on our momentum in 2018 as we move forward with our NasoVAX, SparVax-L and NasoShield programs."

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Financial Results for the Year Ended December 31, 2017

Revenue for the year ended December 31, 2017 was $10.7 million compared to $3.2 million for 2016. The increase was due to $5.7 million increase in revenue from our contract with BARDA and $1.8 million revenue from the NIAID contract we assumed from our merger with PharmAthene in May 2017.

Research and development expenses were $18.4 million for the year ended December 31, 2017 compared to $7.2 million for 2016. The increase in research and development expenses was primarily the result of increases relating to NasoShield, NasoVAX, HepTcell, and SparVax-L clinical and preclinical trial costs, partially offset by $0.5 million reduced spending on the Oncosyn program. Research and development expenses for the year ended December 31, 2016 did not include PharmAthene or costs incurred under the NIAID contract.

General and administrative expenses were $8.5 million for the year ended December 31, 2017, compared to $7.1 million for 2016. The increase was the combined result of increased professional fees related to the merger with PharmAthene and costs incurred by us as a public company, including insurance costs and stock compensation expense, offset by $2.4 million of costs related to our initial public offering incurred in 2016 that did not recur in 2017.

We determined that our goodwill was impaired and a non-cash goodwill impairment charge of $35.9 million was recorded during the year ended December 31, 2017 which was classified as a component of operating expenses. The non-cash charge resulted from our goodwill assessment based on our market capitalization plus an implied control premium relative to the carrying value of our net assets. The non-cash charge has no effect on our current cash balance or operating cash flows.

We recorded an income tax benefit of $5.6 million during the year ended December 31, 2017, which reflected estimated tax refunds we expect to receive from carrying back our 2017 net operating losses to offset the 2016 federal and state income taxes paid by PharmAthene.

Net loss attributable to common stockholders for the year ended December 31, 2017 was $51.4 million compared with $11.5 million for 2016. Excluding the non-cash goodwill impairment charges, net loss attributable to common stockholders for the year ended December 31, 2017 was $15.4 million compared to $11.5 million for 2016.

Net loss per share attributable to common stockholders for the year ended December 31, 2017 was ($4.01) compared with ($1.66) for 2016. Excluding the non-cash goodwill impairment charges, net loss per share attributable to common stockholders for the year ended December 31, 2017 was ($1.21), compared to ($1.66) for 2016.

At December 31, 2017, the Company had cash, cash equivalents, and restricted cash of approximately $12.3 million, of which $3.5 million was restricted under the terms of the Series B preferred offering.

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Non-GAAP Measures

To supplement the Company’s unaudited financial statements presented in accordance with generally accepted accounting principles ("GAAP"), this press release includes a discussion of adjusted net loss attributable to common stockholders and adjusted net loss per share attributable to common stockholders, in each case adjusted for the loss due to a goodwill impairment charge. The Company believes that these non-GAAP measures, when taken into consideration with the corresponding GAAP financial measures, provide investors with meaningful comparisons of current results to prior period results by excluding items that the Company does not believe reflect its fundamental business performance. See the attached schedule for a reconciliation of net loss to adjusted net loss and loss per share to adjusted loss per share for the twelve months ended December 31, 2017 and 2016.