NANOBIOTIX Provides Business Update and Reports Full Year 2022 Financial Results

Nanobiotix SA

25/04/2023 24:33

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* Pivotal Phase 3 trial NANORAY-312 ongoing globally with 104 sites activated
in 25 countries to date; interim efficacy analysis after 67% of planned
progression free survival (PFS) events expected in H2 2024, as planned
* Final data from Study 102 in head and neck cancer expected in H2 2023
* First pancreatic cancer data expected from MD Anderson trial in H2 2023
* Chief Medical Officer with strategically aligned multidisciplinary
experience in oncology expected to join the company in Q3 2023
* Reported €41.4 million in cash and cash equivalents as of December 31,
2022
* 2022 Universal Registration Document filed with the French financial market
authority and the 2022 Annual Report on Form 20-F filed with the U.S.
Securities and Exchange Commission
Conference call and webcast scheduled for Tuesday, April 25 at 2:00 P.M.
CEST/8:00 A.M. EDT

PARIS and CAMBRIDGE, Mass., April 24, 2023 (GLOBE NEWSWIRE) -- NANOBIOTIX
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(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 reported financial results for the year ended December 31, 2022,
and announced the filing of its universal registration document (URD) for the
financial year ended December 31, 2022 with the French financial market
authority (Autorité des marchés financiers or AMF), as well as of the Annual
Report on Form 20-F for the financial year ended December 31, 2022 with the
U.S. Securities and Exchange Commission (SEC).

“2022 was a year that saw a leap forward in our ambition of bringing our
lead nanotherapeutic candidate, NBTXR3, to elderly patients with head and neck
cancer through the recruitment of the first patients across all major regions
in our pivotal Phase 3 study, NANORAY-312,” said Laurent Levy, co-founder of
Nanobiotix and chairman of the executive board. “This past year also tested
our agility. Against continued volatility in the capital markets, our team was
proactive in prioritizing critical development programs, driving efficiencies
to reduce expense and extending our operating runway without hampering our
development capability. Moreover, while our team rightly focused on delivering
our near-term priorities, we also continued to build our leadership for the
future with the addition of our Global Chief Clinical and Medical Affairs
Officer, Leonard A. Farber, M.D., and the establishment of our multi-national,
multi-disciplinary Scientific Advisory Board. I am confident that the momentum
we built in 2022 has positioned us for continued success in 2023 and am
grateful to all involved in supporting our mission.”

2022 Operational Highlights, Pipeline Status and Upcoming Milestones
* Strengthened executive leadership with appointment of Leonard Farber, M.D.,
as Chief Clinical and Medical Affairs Officer
* Established Nanobiotix Scientific Advisory Board with leading global
radiation, medical and surgical oncologists involved in oncology treatment
decision-making, clinical trial investigation and patient recruitment to
further support clinical development of NBTXR3
* Chief Medical Officer (CMO) candidate with strategically aligned experience
in oncology and immuno-oncology is expected to join the organization in Q3
2023
Priority Registration Pathway in Locally Advanced Head & Neck Squamous Cell
Carcinoma (LA-HNSCC), Local Control as Single Agent Activated by Radiotherapy
(RT):
* NANORAY-312 Phase 3 trial evaluating RT-activated NBTXR3 ± cetuximab vs RT
± cetuximab in elderly patients with LA-HNSCC * Initiation across core
geographical sites in Europe, Asia (in collaboration with LianBio), and the
United States with 104 sites activated across 25 countries
* Futility analysis to be conducted following 25% of planned PFS events
expected in H1 24
* Initial Phase 3 interim efficacy and safety data expected after 67% of
planned PFS events in H2 2024
 
* Study 102 Phase 1 trial evaluating RT-activated NBTXR3 in LA-HNSCC *
Completed enrollment in expansion phase
* Interim update in February 2022 reported ongoing median overall survival of
17.9 months in the all-treated population (n=56) and 23.0 months in evaluable
patients (n=44)
* Final safety and efficacy data expected in H2 2023
Priority Pathway in Immunotherapy for Recurrent/Metastatic Head & Neck
Squamous Cell Carcinoma (R/M HNSCC), Priming Immune Response Prior to an
Anti-PD-1 Treatment:
* Study 1100 Phase 1 dose escalation and expansion trial evaluating
RT-activated NBTXR3 followed by an anti-PD-1 in patients with advanced cancers
* Completed enrollment in the escalation phase, established recommended Phase
2 dose (RP2D) and initiated enrollment in expansion cohorts
* Phase 1 escalation data update presented at the Society for Immunotherapy of
Cancer (SITC) 2022 annual conference; Objective reduction in target lesion/s,
seen in 71% of evaluable patients, resulted in durable control in both
anti-PD-1 naive and resistant lesions including 8 patients achieving over 6
months disease control and 5 patients with over 12 months
* Study 1100 Phase 1 data update anticipated at a time to be determined
 
* Phase 3 registrational program for patients with unresectable locoregional
recurrent (LRR) or recurrent or metastatic HNSCC resistant to previous
anti-PD-1/PD-L1 therapy * Received preliminary feedback from FDA suggesting a
single, randomized, controlled trial including a pre-specified comparative
analysis of overall response rate (ORR) may support accelerated approval,
subject to confirmation of clinical benefit based on overall survival (OS)
results from the same trial
* Company plans to consult with incoming CMO prior to continuing discussions
with FDA on potential registration pathway for an NBTXR3-immunotherapy
approach, and expects to provide an update in Q3 2023
Expanding NBTXR3 Opportunity, Collaborating with World-Class Partners to
Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profile:
* Ongoing collaboration with The University of Texas MD Anderson Cancer Center
* Determined RP2D for NBTXR3 in pancreatic ductal adenocarcinoma (PDAC) and
demonstrated positive preliminary qualitative efficacy data
* Preliminary Phase 1b dose escalation safety data in PDAC expected in H2 2023
* Completion of enrollment in Phase 1b dose expansion trial for PDAC expected
in H2 2023
* Determination of RP2D for NBTXR3 in non-small cell lung cancer (NSCLC)
expected in H2 2023
* Initial Phase 1b/2 data for NBTXR3 in combination with an immunotherapy in
patients with esophageal cancer expected in 2024
Full Year 2022 Financial Results

Revenue and Other Income: No revenue was recognized for the year ended
December 31, 2022. The limited revenue during the year ended December 31,
2021, was mainly derived from the charging-back of external contract research
organization costs incurred on behalf of former partner PharmaEngine in
connection with the now terminated license and collaboration agreement.

Total other income increased significantly to €4.8 million for the year
ended December 31, 2022, compared to €2.6 million and €2.5 million for the
years ended December 31, 2021, and 2020, respectively, mainly due to higher
research tax credit.

Research and Development (“R&D”) Expenses: R&D expenses consist primarily
of preclinical, clinical, and manufacturing expenses related to the
development of NBTXR3 and totaled €32.6 million for the twelve-month period
ended December 31, 2022, as compared to €30.4 million for the twelve months
ended December 31, 2021. The increase in net R&D expenses was primarily due to
increases in development costs related to the Company’s priority pathways,
including initiation of its pivotal Phase 3 registration study, NANORAY-312,
continuation of Expansion Study 102 and its ongoing immunotherapy combination
Study 1100 as well as increases in personnel related expenses.

Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses
decreased by €1.6 million, or 8.1%, from €19.4 million for the year ended
December 31, 2021, to €17.9 million for the year ended December 31, 2022.
This year-over-year decrease reflects the Company’s efforts to rationalize
SG&A and internalize certain functions.

Net loss: Net loss attributable to shareholders was €57.0 million, or
€1.64 per share, for the twelve-month period ended December 31, 2022. This
compares to a net loss of €47.0 million, or €1.35 per share for the year
ended December 31, 2021. Our operating loss decreased from €52.6 million in
2021 to €46.7 million in 2022; this operating loss improvement was offset
mainly by a negative €6.9 million one-time debt valuation impact in 2022 as
well as higher debt interest charges, together with €3.1 million lower
foreign exchange gains.

Cash and Cash Equivalents: As of December 31, 2022, Nanobiotix had €41.4
million in cash and cash equivalents, compared to €83.9 million as of
December 31, 2021.

Financial Guidance: Based on the current operating plan and financial
projections, Nanobiotix anticipates that the cash and cash equivalents of
€41.4 million as of December 31, 2022, in conjunction with its previously
announced equity line financing will fund its operations into the third
quarter of 2023.

Going Concern: We have prepared our consolidated financial statements assuming
that we will continue as a going concern. We experienced net losses of €57.0
million in 2022 and a net decrease in cash and cash equivalents of €42.5
million in 2022. At December 31, 2022, our accumulated deficit was €227.3
million and we had negative working capital of €22.7 million. We expect to
continue to incur significant expense related to the development and
manufacturing of nanotechnology product candidates such as NBTXR3 and
conducting clinical studies. Additionally, we may encounter unforeseen
difficulties, complications, development delays and other unknown factors that
require additional expense. As a result of these expenditures, we expect to
continue to incur significant losses in the near term. Additionally, the EIB
loan contain covenants that require maintenance of minimum cash and cash
equivalent balances that limit the availability of cash resources to pursue
operational needs.

The Company’s covenant obligations entail that the current cash and cash
equivalents are only sufficient to fund our operating expenses into the third
quarter of 2023. Violation of the covenant would result in immediate repayment
of all or part of the loan outstanding (if and when requested by the EIB),
together with accrued interest, prepayment fees and all other accrued or
outstanding amounts. However, Nanobiotix has obtained a 15 million euros
temporary waiver, until July 31, 2023, and has reached an agreement in
principle with the EIB to automatically extend it until January 31, 2024
should a business development partnership, collaborative or strategic alliance
have become effective before July 31, 2023. If the company secures this
extension period, or if the company obtains appropriate funding prior, the
Company is not expected to be in breach of this temporary waiver as of July
31, 2023.

The Company is also pursuing additional funding through one or more possible
new partnerships, collaborative or strategic alliances; or from the use of the
equity line (PACEO) signed with Kepler Cheuvreux, financing from institutional
or strategic investors, from the capital markets, or a combination of the
above. However, the Company cannot guarantee if or when any such transactions
will occur or whether they will be on satisfactory terms.

While the Company has taken and will continue to take actions to obtain new
funding and manage costs through operating expense reduction plans, as
necessary, the above factors indicate substantial risk about the Company’s
ability to continue as a going concern as there is no assurance that the
Company will be successful in satisfying its future cash needs.

Subsequently, the Executive Board determined it is appropriate to prepare
consolidated financial statements as of and for the period ended December 31,
2022, applying a going concern basis, assuming the Company will continue to
operate for the foreseeable future. The supervisory board of the Company has
reviewed and closed the FY 2022 on April 24, 2023.

Availability of the Full Year 2022 Financial Reports

The URD and 20-F are available on the Nanobiotix website at
https://ir.nanobiotix.com/financial-information/annual-reports. In addition,
the URD is available on the AMF website (www.amf-france.org) and the 20-F is
available on the SEC website (www.sec.gov).

The Company’s 2022 URD includes its:
* 2022 annual financial report including the report on corporate governance
* Reports from the Company’s statutory auditors and information on their
fees
* Required information in relation to the Company’s share buyback program
Conference Call and Webcast

Nanobiotix will host a conference call and live audio webcast on Tuesday,
April 25, 2023, at 8:00 AM EDT / 2:00 PM CEST, prior to the open of the U.S.
market. During the call, Laurent Levy, chief executive officer, and Bart van
Rhijn, chief financial officer, will briefly review the Company’s year-end
results and an update on business activities before taking questions from
participants.

Details for the call are as follows:

Live (US): 1-877-423-9813

Live France: 0 800 912 848

Live (international): 1-201-689-8573

Call me™: click here
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Participants can use guest dial-in numbers above and be answered by an
operator or they can click the Call me™ link for instant telephone access to
the event (dial-out). The Call me™ link will be made active 15 minutes prior
to scheduled start time. A live webcast of the call may be accessed by
visiting the investors section of the Company’s website at
www.nanobiotix.com. It is recommended to join 10 minutes prior the event
start. A replay of the webcast will be available shortly after the conclusion
of the call and will be archived on the Company’s website.

Participants are invited to email their questions in advance to
investors@nanobiotix.com.

About NBTXR3

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 1 dose escalation and dose expansion study has produced favorable safety
data and early signs of efficacy; and a Phase 3 global registrational study
was launched 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 Phase
3 study.

Nanobiotix has also prioritized an Immuno-Oncology development
program—beginning with a Company-sponsored Phase 1 clinical study evaluating
NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint
inhibitors for patients with locoregional recurrent or recurrent/metastatic
HNSCC, or 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 1 and Phase 2 studies to evaluate NBTXR3 across tumor
types and therapeutic combinations.

About NANOBIOTIX

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 Euronext Paris since
2012 and on the Nasdaq Global Select Market in New York City since December
2020.

Nanobiotix is the owner of more than 20 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(®).

For more information about Nanobiotix, visit us at www.nanobiotix.com or
follow us on LinkedIn
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Disclaimer

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. 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 early clinical results 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, the risk
that the EIB may accelerate the loans under finance contract and its amendment
upon the occurrence of customary events of default; the risk that Company may
not be able to secure additional capital on attractive terms, if at all.
Furthermore, many other important risks factors and uncertainties, including
those described in our Annual Report on Form 20-F filed with the U.S.
Securities and Exchange Commission (the SEC) on April 24, 2023 under “Item
3.D. Risk Factors” and those set forth in the universal registration
document of Nanobiotix filed with the French Financial Markets Authority
(Autorité des Marchés Financiers – the AMF) on April 24, 2023, (a copy of
which is available on www.nanobiotix.com) 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.

Contacts

 Nanobiotix                                                                                                                                                                                                           
 Communications Department Brandon Owens VP, Communications +1 (617) 852-4835 contact@nanobiotix.com     Investor Relations Department Craig West SVP, Investor Relations +1 (617) 583-0211 investors@nanobiotix.com  
 Media Relations                                                                                                                                                                                                      
 FR – Ulysse Communication Pierre-Louis Germain + 33 (0) 6 64 79 97 51 plgermain@ulysse-communication    Global – LifeSci Advisors Ligia Vela-Reid +44 (0) 7413825310 Lvela-reid@lifesciadvisors.com                  



 Statements of consolidated operations                                                  
 (Amounts in thousands of euros, except per share numbers)                              
                                                                                        
                                                 For the year ended December 31,        
                                                 2022                      2021         
 Revenues and other income                                                              
 Revenues                                        —                         10           
 Other income                                    4,776                     2,637        
 Total revenues and other income                 4,776                     2,647        
 Research and development expenses               (32,636)                  (30,378)     
 Selling, general and administrative expenses    (17,857)                  (19,434)     
 Other operating and income expenses             (985)                     (5,414)      
 Total operating expenses                        (51,478)                  (55,226)     
 Operating income (loss)                         (46,702)                  (52,579)     
 Financial income                                3,533                     6,360        
 Financial expenses                              (13,863)                  (780)        
 Financial income (loss)                         (10,329)                  5,580        
 Income tax                                      (10)                      (5)          
 Net loss for the period                         (57,041)                  (47,003)     
 Basic loss per share (euros/share)              (1.64)                    (1.35)       
 Diluted loss per share (euros/share)            (1.64)                    (1.35)       

 

 Statements of consolidated financial position                                
 (Amounts in thousands of euros, except per share numbers)                    
                                                                              
                                                 As of December 31,           
                                                 2022               2021      
 Total non-current assets                        7,412              8,709     
 Cash and cash equivalents                       41,388             83,921    
 Total current assets                            52,358             93,060    
 TOTAL ASSETS                                    59,769             101,769   
 Net loss for the period                         (57,041)           (47,003)  
 Total shareholders’ equity                      (27,045)           26,790    
 Total non-current liabilities                   48,878             38,134    
 Total current liabilities                       37,936             36,845    
 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY      59,769             101,769   



Attachment
* 2023-04-24 -- NBTX -- FY22 Financial Results -- FINAL -- English
(https://ml.globenewswire.com/Resource/Download/c479f730-b33e-4ad0-8e22-9f9ec2d21765)