Full Press Release Details
NANOBIOTIX PROVIDES BUSINESS UPDATE AND REPORTS FINANCIAL RESULTS FOR THE FIRST HALF OF 2021
Paris, France; Cambridge, Massachusetts (USA); September 8, 2021 - NANOBIOTIX (Euronext: NANO -- NASDAQ: NBTX - the Company''), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for
patients with cancer, provided an update on operational progress and announced its half year financial results for the six-month period ended June 30, 2021.
First Half Operational Highlights, Pipeline Status and Upcoming Milestones
Priority Pathway in Head & Neck Cancer, Local Control as Single Agent Activated by Radiotherapy: Leveraging proof-of-concept demonstrated in a successful Phase II/III study and subsequent EU marketing authorization for soft tissue sarcoma, Nanobiotix is currently evaluating NBTXR3 as a
single agent activated by radiotherapy in other solid tumor indications with an initial focus on locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
Priority Pathway in Immunotherapy for Advanced Cancers, Priming Immune Response in Combination with Anti-PD-1 Treatment: Given early data showing anti-cancer immune activity triggered by its physical mechanism of action, Nanobiotix is evaluating the potential for NBTXR3 to improve current approaches to
immunotherapy by combining NBTXR3 with anti-PD-1 therapies in advanced cancers to potentially increase the number of patients that respond to treatment and improve outcomes for patients regardless of their prior exposure to immune checkpoint
1 These percentages include one patient recorded by the principal investigator in the Clinical Observation Record as Unconfirmed
Expanding NBTXR3 Opportunity, Collaborating with World-Class Partners to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profile:
"Given our clinical and operational progress in the first half of 2021, we believe we are on track to deliver on the promise of NBTXR3 as a potential first-in-class, solid
tumor-agnostic, combination-agnostic product candidate that could change treatment paradigms in oncology," said Laurent Levy, co-founder and chairman of the executive board of Nanobiotix. "As we prepare for the initiation of our pivotal phase III
study later this year, we are highly encouraged by the consistently strong findings from our phase I expansion study in head and neck cancer presented earlier this year and eagerly anticipate reporting progression free survival and overall survival
data from this study in the fourth quarter. Taken together with data we have reported on the potential of NBTXR3 in immunotherapy and the series of studies initiated by MD Anderson exploring NBTXR3 across additional solid tumor types and therapeutic
combinations, we continue to achieve critical milestones on our journey to improve outcomes for patients throughout oncology."
Financial Results for the First Half of 2021
Cash and Cash Equivalents: Cash and cash equivalents as
of June 30, 2021, were 102.3 million, expected to support development plans into the first quarter of 2023. This amount includes the 16.5 million ($20.0 million) upfront payment associated with the LianBio collaboration announced in May 2021. As
previously announced, PharmaEngine was eligible for and received a 2.1 million ($2.5 million) payment following the announcement of the LianBio collaboration and has received 3.3 million ($4.0 million) in conjunction with the completion of
various administrative steps in connection with the winding-up of the collaboration. PharmaEngine will be eligible to receive an additional $1.0 million in administrative fees, a final payment of $5 million upon a second regulatory approval of an
NBTXR3-containing product as well as low-single digit royalties for a limited period following approval in the region.
Revenue: Revenue for the first half of 2021 totaled 9.7
thousand compared to 36.9 thousand for the first half of 2020. Revenue for the six months ended June 30, 2021 and June 30, 2020 mainly corresponded to the charging back of cost incurred in connection with the Company previous collaboration with
Research and Development ("R&D") Expenses: R&D
expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of NBTXR3. These expenses for the six months ended June 30, 2021, were 15.5 million, compared to 13.1 million for the six months ended June
30, 2020. Purchases, sub-contracting and other expenses increased by 2.3 million for the six months ended June 30, 2021 as compared with the same period in 2020. This increase reflects the impact of COVID-19 pandemic in 2020 and the Company's
focus on advancing its clinical trial development priorities in 2021.
Selling, General and Administrative ("SG&A") Expenses: SG&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the six months ended June 30, 2021, were
10.2 million, compared to 6.8 million for the prior-year six-month period. This increase of 3.4 million was primarily due to expenses relating to partnership agreements as well as consulting fees, legal & compliance expenses following the
Company's Nasdaq listing, and recruitment expenses.
Net loss: Net loss attributable to common shareholders
for the six months ended June 30, 2021 was 30.4 million, or 0.88 per share. This compares to a net loss attributable to common shareholders of 20.6 million, or 0.91 per share, for the same period in 2020. The 9.8 million increase in net loss
compared to the first half of 2020 was primarily driven by the 5.4 million in operating expenses associated with the termination of the PharmaEngine agreement during the first half of 2021.
These results are represented in the condensed consolidated financial statements as of June 30, 2021, approved by the executive board of the Company on September 8, 2021, and
reviewed by the supervisory board of the Company on the same date, and have been subjected to a limited review by the Company's statutory auditors.
Availability of the half-year financial report
The 2021 half-year financial report has been filed with the French Financial markets authority (Autorit des march s financiers). It is available to the public and can be
consulted on the company's website, www.nanobiotix.com.
Updated Financial Agenda
October 20th, 2021: Third Quarter Corporate and Financial Update
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection
and activated by radiotherapy. The product candidate's physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and
long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.
NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation
and dose expansion study has produced favorable safety data and early signs of efficacy; and a phase III global registrational study is planned to launch in 2021. In February 2020, the United States Food and Drug Administration granted regulatory
Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy-the same population being
evaluated in the planned phase III study.
Nanobiotix has also prioritized an Immuno-Oncology development program-beginning with a Company-sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy
in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.
Given the Company's focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners
to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD
Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.
Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of
patients; supported by people committed to making a difference for humanity. The company's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.
Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany.
Nanobiotix has been listed on the regulated market of Euronext in Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.
Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and
biodistribution; and 3) disorders of the central nervous system. The company's resources are primarily devoted to the development of its lead product candidate-NBTXR3-which is the product of its proprietary oncology platform and has already achieved
market authorization in Europe for the treatment of patients with soft tissue sarcoma under the brand name Hensify .
This press release contains certain "forward-looking" statements within the meaning
of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan,"
"scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information currently available to management, include
statements about the timing and progress of clinical trials, the timing of our presentation of data, the results of our preclinical and clinical studies and their potential implications, the development and commercialization of NBTXR3, and the execution of the Company's development and commercialization strategy. Such
forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties,
including with respect to the risk that subsequent studies and ongoing or future clinical trials may not generate favorable data notwithstanding positive preclinical or early clinical result and the risks associated with the evolving nature of the
duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to it. Furthermore, many other important factors, including those described in Annual Report on Form 20-F filed with the U.S. Securities
and Exchange Commission on April 7, 2021 under "Item 3.D. Risk Factors", those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorit des march s financiers or "AMF") under number
D.21-0272 on April 7, 2021 (a copy of which is available on www.nanobiotix.com),
as well as those set forth in the half-year financial report filed with the AMF on September 8, 2021 (a copy of which is available on www.nanobiotix.com), as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to
be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could
differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
| Nanobiotix | |
| Nanobiotix Communications Brandon Owens VP, Communications +1 (617) 852-4835 contact@nanobiotix.com | Nanobiotix Investor Relations Kate McNeil SVP, Investor Relations +1 (609) 678-7388 investors@nanobiotix.com |
| Media Relations | |
| France - Ulysse Communication Pierre-Louis Germain + 33 (0) 6 64 79 97 51 plgermain@ulysse-communication.com | US - Porter Novelli Dan Childs +1 (781) 888-5106 Dan.childs@porternovelli.com |
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| For the six month period ended | |||||
| June 30, 2021 | June 30, 2020 | ||||
| Revenues and other income | |||||
| Revenues | 10 | 37 | |||
| Other income | 1,309 | 1,411 | |||
| Total revenues and other income | 1,319 | 1,448 | |||
| Research and development expenses | -15,506 | -13,077 | |||
| Selling, general and administrative expenses | -10,176 | -6,755 | |||
| Other operating income and expenses | -5.414 | - | |||
| Total operating expenses | -31,096 | -19,832 | |||
| Operating income (loss) | -29,778 | -18,384 | |||
| Financial income | 2,511 | 234 | |||
| Financial expenses | -3,152 | -2,428 | |||
| Financial income (loss) | -640 | -2,194 | |||
| Income tax | -2 | -1 | |||
| Net loss for the period | -30,420 | -20,579 | |||
| Basic loss per share (euros/share) | (0.88) | (0.91) | |||
| Diluted loss per share (euros/share) | (0.88) | (0.91) |
Condensed Consolidated Balance Sheet Data
| As of | |||
| June 30, 2021 | December 31, 2020 | ||
| Total non-current assets | 8,045 | 8,782 | |
| - Cash and Cash equivalents | 102,336 | 119,151 | |
| Total current assets | 115,870 | 125,248 | |
| TOTAL ASSETS | 123,915 | 134,030 | |
| - Net loss for the period | -30,420 | -33,590 | |
| Total shareholders' equity | 41,431 | 70,468 | |
| Total non-current liabilities | 44,445 | 44,522 | |
| Total current liabilities | 38,038 | 19,041 | |
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 123,915 | 134,030 |