On February 26, 2021 NANOBIOTIX (Euronext : NANO – NASDAQ: NBTX – the ‘‘Company’’), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported its revenues for the fourth quarter and full year ended December 31, 2020 (Press release, Nanobiotix, FEB 26, 2021, View Source [SID1234575767]).

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Full Year 2020 Revenue

Full Year and Fourth Quarter 2020 Financial Results

Nanobiotix generated annual revenue of approximately €50K, driven primarily by the charging-back of costs incurred on behalf of PharmaEngine in connection with the Company’s license and collaboration agreement with PharmaEngine. The absence of revenues in the fourth quarter of 2020 is explained by the issuance of a credit note following an annual adjustment.

The Company’s cash and cash equivalents as of December 31st, 2020 amounted to €119.2M following completion of a successful U.S. initial public offering on the Nasdaq Global Select Market in December 2020 resulting in total gross proceeds of €93.5 million ($113.3 million based on an exchange rate of €1.00=$1.2115). Net proceeds, after deducting underwriting commissions and other offering expenses, were €82.8 million (€100.4 million). Nanobiotix anticipates that its current cash position will be sufficient to fund current operations and planned development activity through the middle of the second quarter of 2023.

Key Events in Fourth Quarter 2020 and After the Reporting Period

In October 2020, Nanobiotix announced that the first patient had been injected with NBTXR3 in the Company’s phase I trial evaluating NBTXR3 activated by radiation therapy for patients with pancreatic cancer, and that "safe to proceed" notifications had been received from the U.S. Food and Drug Administration (FDA) for two additional trials: (i) a phase I study evaluating NBTXR3 activated by radiation therapy for patients with lung cancer amenable to re-irradiation (Study 2020-0123) and (ii) a phase I study evaluating NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer (Study 2020-0122). These studies are being conducted as part of an ongoing clinical collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson).

In November 2020, the Company presented positive first clinical data at the 35th Anniversary Annual Meeting of The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) suggesting that NBTXR3 activated by radiation therapy in combination with pembrolizumab or nivolumab (anti-PD-1 checkpoint inhibitors) could transformanti-PD-1 non-responders into responders.

At SITC (Free SITC Whitepaper), Nanobiotix also published a pre-clinical study revealing that NBTXR3 activated by radiotherapy could under certain circumstances produce a strong abscopal effect without checkpoint inhibitor combination, stimulate adaptive antitumor immunity and increase TCR repertoire diversity in treated tumors compared to radiation therapy alone.

A second pre-clinical study presented at SITC (Free SITC Whitepaper) showed that NBTXR3 plus high dose and low dose radiation (RadScopal) combined with anti-PD-1 and anti-CTLA-4 could significantly improve control of both the primary and secondary tumors, extend survival, and reduce lung metastases in an anti-PD-1 resistant lung cancer in vivo model—and the treatment combination was observed to promote an anti-tumor response at both molecular and cellular levels and to produce long-term anti-tumor memory.

Also in November 2020, Nanobiotix announced that the FDA had provided "safe to proceed" notifications for two additional phase II clinical studies with MD Anderson. The first clinical study (Study 2020-0541) targets patients with recurrent or metastatic head and neck squamous cell carcinoma with limited PD-L1 expression, or that are refractory to PD-1 blockade. The second clinical study (Study 2020-0354) targets patients with inoperable locoregional recurrent head and neck squamous cell carcinoma amenable to re-irradiation.

In December 2020, Nanobiotix successfully completed its U.S. initial public offering on the Nasdaq Global Select Market, the operation also included the launch of a placement in Euronext market.

In January 2021, Nanobiotix announced that the first patient has been injected in a phase I study evaluating tumor-agnostic NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer (Study 2020-0122).

Also in January 2021, Nanobiotix announced that its wholly-owned subsidiary Curadigm was selected for a new collaboration agreement with Sanofi. Pursuant to Sanofi’s selection of a project involving Curadigm’s Nanoprimer technology as a promising option to significantly improve gene therapy development, Curadigm entered into a one-year agreement with Sanofi inclusive of direct funding and scientific exchanges. The goal of the project is to establish proof-of-concept for the Nanoprimer as a combination product that could improve treatment outcomes for gene therapy candidates.

2021 Financial Agenda

Nanobiotix plans to announce its financial and operating results as follows:

March 17, 2021 – 2020 Full Annual Results
April 28, 2021 – Annual General Meeting, Paris, France
April 30, 2021 – First Quarter 2021 Revenues
July 16, 2021 – Second Quarter 2021 Revenues
September 3, 2021 – 2021 Half Year Results
October 22, 2021 – Third Quarter 2021 Revenues

On February 26, 2021 GENFIT (Nasdaq and Euronext: GNFT), a late- stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, reported its cash position as of December 31, 2020 and revenues for 2020 (Press release, Genfit, FEB 26, 2021, View Source [SID1234575766]).

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Financials

As of December 31, 2020, the Company’s cash and cash equivalents amounted to €171.0 million compared with €276.7 million, as of December 31, 2019.

As of June 30, 2020, cash and cash equivalents amounted to €225.7 million.

The cash position as of December 31, 2020 omits the cost of the partial buyback by the Company for its convertible bonds (OCEANEs) issued in October 2017 and amounting to approximately €180 million. Following the completion of this transaction, €85.7 million of convertible debt was canceled by spending a gross amount of only €47.48 million.

Given the conversions of bonds into shares in January 2021, which led to the creation of 3,037,309 new shares in February 2021, the residual convertible debt, initially reduced to a nominal amount of €94.3 million through the partial buyback transaction, was further reduced by a nominal amount of €16.3 million, with approximately €78 million outstanding as of February 18, 2021.

Pascal Prigent, CEO of GENFIT, commented: "Since the announcement of our new corporate strategy in the Fall of 2020, GENFIT has achieved a significant amount and I’m satisfied with the early direction of 2021. ELATIVETM, our Phase 3 clinical trial in PBC, is on track, and we recently organized a KOL event on this disease, which highlighted the potential of elafibranor in this market already worth >$300M in 2020, and expected to reach $1bn in 2025, at the time we hope to launch. Next to this, we successfully restructured the convertible debt at the end of January 2021, with a maturity extended to October 2025. Some bondholders have since converted their OCEANEs, further reducing the outstanding debt to approximately €78 million. We will present advances on our R&D programs at the next corporate update, to take place before the summer."

1Excluding transaction-related costs
2Unaudited financial information under IFRS

Revenues3

Revenues for 2020 amounted to €765 thousand compared to €31 million for 2019.

Revenues included revenues from the licensing agreements with Covance/Labcorp to roll out the NIS4 diagnostic technology in NASH and the sale of goods and services provided pursuant to the collaboration and license agreement with Terns Pharmaceuticals. As a comparison, revenues for 2019 mainly consisted of the $35 million upfront payment received from Terns Pharmaceuticals as part of the collaboration and license agreement.

Reminder

On September 30, 2020, GENFIT announced its plan to reduce its cash burn by 50% by 2022 compared to the cash burn before the publication of the RESOLVE-IT Phase 3 data readout.

The Company reiterates its goal to reduce the cash burn rate from €110 million annually before our Phase 3 data, to approximately €45 million annually, beginning in 2022. 2021 will be a transition year with a cash burn of approximately €75 million (excluding the partial OCEANEs buyback transaction for €47.48 million in cash) mainly due to the residual expenses related to the termination of the RESOLVE-IT clinical trial, and to costs associated with the workforce reduction plan.

Upcoming Financial Communications

The Company will release its full-year 2020 financial results on April 1, 2021. The 2020 Universal Registration Document, the 2021 Annual Financial Report (included in the 2020 Universal Registration Document), and the Annual Report on Form 20-F will be published by the end of April 2021.

On February 26, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Friday, March 5, 2021, at 8:30 am ET to discuss a corporate update and financial results for the fourth quarter and full year 2020 (Press release, Oncolytics Biotech, FEB 26, 2021, View Source [SID1234575765]).

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Conference Call & Webcast

A live webcast of the call will also be available on the Investor Relations page of Oncolytics’ website, available by clicking here and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (855) 859-2056 (North America) or (416) 849-0833 (International) and using reference code: 569-6653.

On February 26, 2021 Sanofi reported The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a second indication for Sarclisa (isatuximab), in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy (Press release, Sanofi, FEB 26, 2021, View Source [SID1234575764]).

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"Sarclisa has demonstrated superior results in combination with two standard of care regimens, reinforcing its potential to become the anti-CD38 of choice for the treatment of multiple myeloma," said Peter Adamson, Global Development Head, Oncology and Pediatric Innovation at Sanofi. "We look forward to partnering with the European Commission to make Sarclisa available to more patients and are committed to investigating Sarclisa in combination with current standard of care treatments throughout all lines of multiple myeloma therapy."

Sarclisa is currently approved for use in the European Union (EU) in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory MM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

The use of Sarclisa in combination with carfilzomib and dexamethasone is not currently approved in the EU, but the final decision whether to expand the indication is expected from the European Commission in the coming months.

Sarclisa Phase 3 study results in patients with MM

The CHMP positive opinion is based on data from the Phase 3 IKEMA study, a randomized, multi-center, open label clinical trial that enrolled 302 patients with relapsed multiple myeloma across 69 centers spanning 16 countries. The primary endpoint of IKEMA was progression free survival (PFS). While median PFS, defined as time to disease progression or death, for Kd was 19.15 months, the median PFS for patients receiving Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination therapy; n=179) had not been reached at the time of the pre-planned interim analysis. Sarclisa combination therapy reduced the risk of disease progression or death by 47% (hazard ratio 0.531, 99% CI 0.318-0.889, p=0.0007) versus standard of care Kd alone in patients with MM.

Secondary endpoints of the IKEMA trial assessed the depth of response for Sarclisa combination therapy compared to Kd, including overall response rate (ORR), complete response (CR), very good partial response (VGPR) and minimal residual disease (MRD)-negative response. There was no statistically significant difference in ORR, which remained similar for each arm at 86.6% for the Sarclisa combination therapy versus 82.9% for Kd (p=0.1930). The rate of CR was 39.7% in the Sarclisa combination therapy arm and 27.6% in the Kd arm. The rate of VGPR was 72.6% for patients receiving Sarclisa combination therapy and 56.1% for patients receiving Kd. MRD-negative complete response was observed in 29.6% of patients in the Sarclisa combination therapy arm versus 13% of patients in the Kd arm, indicating that nearly 30% of patients treated with Sarclisa combination therapy achieved undetectable levels of MM at 10-5 sensitivity as measured by next generation sequencing (NGS). At the time of the interim analysis, overall survival (OS) data were still immature.

The most frequent adverse reactions (≥20%) were infusion reactions (45.8%), hypertension (36.7%), diarrhea (36.2%), upper respiratory tract infection (36.2%), pneumonia (28.8%), fatigue (28.2%), dyspnea (27.7%), insomnia (23.7%), bronchitis (22.6%), and back pain (22.0%). Serious adverse reactions occurred in 59.3% of patients receiving Sarclisa combination therapy and versus 57.4% in patients receiving Kd. The most frequent serious adverse reaction was pneumonia (21.5%). Permanent discontinuation of treatment because of adverse reactions was reported in 8.5% of patients treated with Sarclisa combination therapy and in 13.9% of patients treated with Kd. Fatal adverse events were reported in 3.4% of patients treated with Sarclisa combination therapy and in 1.6% of patients treated with Kd.

Multiple Myeloma: An incurable cancer, despite available treatments

Multiple myeloma is the second most common hematologic malignancy1, with more than 130,000 new diagnoses of multiple myeloma worldwide yearly.2 In Europe, approximately 39,000 patients are diagnosed with multiple myeloma each year.3 Despite available treatments, multiple myeloma remains an incurable malignancy, and is associated with significant patient burden. Since multiple myeloma does not have a cure, most patients will relapse. Relapsed multiple myeloma is the term for when the cancer returns after treatment or a period of remission. Refractory multiple myeloma refers to when the cancer does not respond or no longer responds to therapy.

About Sarclisa

Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

Sarclisa is approved in the EU, U.S., Switzerland, Canada, Australia, Japan, Russia, the UAE, South Korea and Taiwan in combination with pom-dex for the treatment of certain adults with relapsed refractory MM. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been reviewed by any regulatory authority worldwide.

On February 26, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that Jack Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the Cowen 41st Annual Health Care Conference on Wednesday, March 3, 2021, at 12:20 p.m. ET (Press release, Supernus, FEB 26, 2021, https://ir.supernus.com/news-releases/news-release-details/supernus-present-cowen-healthcare-conference [SID1234575763]).

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A live webcast of the presentation can be accessed by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay will be available for 60 days on the Company’s website following the conference.