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DBV Technologies Reports Full Year 2022 Financial Results and Business Update

On March 2, 2023 Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the full year 2022 (Press release, DBV Technologies, MAR 2, 2023, View Source [SID1234628113]). The audit procedures have been substantially completed by the Company’s statutory auditors and financials – prepared under both US GAAP and IFRS for the purpose of Form 10-K and Universal Registration Document respectively – were approved by the Board of Directors on March 2, 2023.

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EVOLVE

DBV completed EVOLVE, a 12-week caregiver and patient user experience study of the modified Viaskin Peanut patch in 50 peanut allergic children ages 4 – 11-years old. The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the modified Viaskin Peanut patch. The study concluded that the updated Viaskin Peanut IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application. Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the modified Viaskin Peanut patch.

In EVOLVE, DBV also tested the functionality of an electronic patient diary (eDiary) to collect information on activities of daily living and patch adhesion scores. As previously announced, VITESSE will assess patch adhesion of the modified Viaskin Peanut patch and DBV will include a statistical test of adhesion in the VITESSE statistical analysis plan. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA application.

Financial Highlights for the Full Year 2022

The Company’s annual consolidated financial statements are prepared in accordance with both generally accepted accounting principles in the U.S. ("US GAAP") and International Financial Reporting Standards ("IFRS") as adopted by the European Union. Unless otherwise indicated, the financial figures in the Full Year 2022 Financial Highlights are presented under both U.S GAAP and IFRS financial statements, and commented using U.S. GAAP financial statements. Differences between US GAAP and IFRS consolidated financial statements are mainly due to discrepancies arising from the application of lease accounting standards.

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Cash and Cash Equivalents

US GAAP IFRS
Year ended December 31, Year ended December 31,
In millions of USD 2022 2021 2022 2021
Net cash & cash equivalents at the beginning of the period

77,3 196,4 77,3 196,4
Net increase / (decrease) in cash & cash equivalents, of which:

131,9 (119,1 ) 131,9 (119,1 )
Net cash flow used in operating activities

(55,7 ) (108,2 ) (51,4 ) (104,1 )
Net cash flow used in investing activities

(0,1 ) (0,4 ) (0,1 ) (0,4 )
Net cash flow provided by / (used in) financing activities

194,1 0,3 189,9 (3,9 )
Effect of exchange rate changes on cash & cash equivalents

(6,5 ) (10,7 ) (6,5 ) (10,7

Net cash & cash equivalents at the end of the period

209,2 77,3 209,2 77,3

Cash and cash equivalents amount to $209,2 million as of December 31, 2022, compared to $77,3 million as of December 31, 2021, which is an increase by $131,9 million due to:

(1)
$194,1 million due to financing activities, mainly from ATM Program in May 2022 ($14,1 million, net of transaction costs), then from private investment in public equity ($180,4 million, net of transaction costs);

(2)
$26,1 million reimbursed by French tax administration for research tax credits related to years 2019, 2020, and 2021;

And partially offset by :

(3)
$81,8 million of cash used for operations, before $26,1 million reimbursement of research tax credits. This is a decrease of 24% compared to prior year reflecting the cost containment measures that has been continuously maintained since their implementation in 2020.

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US GAAP IFRS
In millions of USD FY22 FY21 FY20 FY22 FY21 FY20
Net cash flow used in operating activities

55,7 108,2 165,6 51,4 104,1 160.9
Reimbursements of Research Tax Credits

26,1 — — 26,1 — —
Net cash flow used in operating activities, excluding reimbursements of Research Tax Credits

81,8 108,2 165,6 77,5 104,1 160,9
Compared to prior year

-26,4 -57,4 -26,6 -56,8
-24 % -35 % -26 % -35 %

(4)
$6,5 million negative impact of changes in exchange rates.

The Company’s treasury position, stated in US Dollars, has benefited in the last quarter from a change in the Euro to US Dollar exchange rate. The company’s activities and expenditures in the fourth quarter were in line with expectations and continue to reflect DBV’s expense discipline.

Operating Income

US GAAP IFRS
Year ended December 31, Year ended December 31,
In millions of USD 2022 2021 Variation 2022 2021 Variation
Research tax credits

5,7 7,5 -1,8 -24 % 5,7 7,5 -1,8 -24 %
Other operating income

(0,9 ) (1,8 ) +0,9 -51 % (0,9 ) (1,8 ) +0,9 -51

Produits opérationnels

4,8 5,7 -0,9 -15 % 4,8 5,7 -0,9 -15

Operating income amounts to $4,8 million as of December 31, 2022, compared to $5,7 million as of December 31, 2021, which is a decrease by $0,9 million due to:

(1)
A decrease in 2022 research tax credit by $1.8 million compared to 2021. This reflects the impact of the global restructuring plan initiated in 2020 and completed in 2021 which has impacted the expenses eligible to the research tax credit.

(2)
Partially offset by the variance in other operating income that consists of revenues recognized in advance of the completion of the collaboration agreement with Nestlé Health Science ("NHS").

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Operating Expenses

US GAAP IFRS
In millions of USD Year ended December 31, Year ended December 31,
2022 2021 Variation 2022 2021 Variation
Research & Development

75,5 70,3 +5,2 +7 % 75,2 70,1 +5,1 +7 %
Sales & Marketing

1,6 4,4 -2,8 -63 % 1,6 4,4 -2,8 -65 %
General & Administrative

24,3 30,5 -6,2 -20 % 24,2 30,4 -6,1 -20 %
Restructuring

— (0,9 ) +0,9 -100 % — (0,9 ) +0,9 -100

Total operating expenses

101,5 104,3 -2,8 -3 % 101,0 104,0 -2,9 -3

including personnel expenses

24,0 31,1 -7,1 -23 % 24,0 31,1 -7,1 -23 %
Operating expenses amount to $101,5 million as of December 31, 2022, compared to $104,3 million as of December 31, 2021, which is a decrease by $2,8 million mainly due to the decrease in personnel expenses as a result of the global restructuring plan that was announced in 2020 and completed in the course of 2021. The average number of employees was 86 for the year ended December 31, 2022, compared to 101 and 270 for the years ended December 31, 2021 and 2020 respectively.

This reduction in our operating expenses also reflects the strict financial discipline maintained across all services to focus our resources on the support of our clinical trial objectives.

Net Loss and Net Loss per Share

US GAAP IFRS
Year ended December 31, Year ended December 31,
2022 2021 Variation 2022 2021 Variation
Net (loss) in millions of USD

(96,3 ) (97,8 ) +1,5 -2 % (96,0 ) (98,1 ) +2,0 -2 %
Basic / diluted net (loss) per share in USD

(1,24 ) (1,78 ) +0,5 -30 % (1,24 ) (1,79 ) +0,6 -31 %
Net result for the year ended December 31, 2022, is a loss amounting to $96,3 million compared to a loss amounting to $97,8 million for the year ended December 31, 2021.

On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) is $1.24 for the year ended December 31, 2022.

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Conference Call Information DBV will host a conference call and live audio webcast today, Thursday, March 2, 2023, at 5:00 p.m. ET to report fourth quarter 2022 financial results and provide a

business update.

Attendees may access the call via the below teleconferencing numbers and asking to join the DBV Technologies call:

•
United States: 1-866-777-2509

•
International: 1-412-317-5413

A live webcast of the call will be available on the Investors & Media section of the Company’s website: View Source A replay of the presentation will also be available on DBV’s website after the event

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CONDENSED STATEMENT OF CONSOLIDATED FINANCIAL POSITION

US GAAP IFRS
Year ended December 31, Year ended December 31,
In millions of USD 2022 2021 2022 2021
Assets

246,5 146,7 246,5 146,3
of which cash & cash equivalents

209,2 77,3 209,2 77,3
Liabilities

52,1 47,4 52,0 47,3
Shareholders’ equity

194,5 99,3 194,5 99,0
of which net result

(96,3 ) (97,8 ) (96,0 ) (98,1 )
CONDENSED STATEMENT OF CONSOLIDATED OPERATIONS AND COMPREHENSIVE LOSS

US GAAP IFRS
In millions of USD Year ended December 31, Year ended December 31,
2022 2021 2022 2021
Revenues

4,8 5,7 4,8 5,7
Research & Development

(75,5 ) (70,3 ) (75,2 ) (70,1 )
Sales & Marketing

(1,6 ) (4,4 ) (1,6 ) (4,4 )
General & Administrative

(24,3 ) (30,5 ) (24,2 ) (30,4 )
Restructuring income/(expenses)

— 0,9 — 0,9
Operating expenses

(101,5 ) (104,3 ) (101,0 ) (104,0 )
Finance income/(expenses)

0,4 0,4 0,3 (0,2 )
Income tax

(0,1 ) 0,4 (0,1 ) 0,4
Net gain/(loss)

(96,3 ) (97,8 ) (96,0 ) (98,1 )
Résultat de base et dilué par action ($/action)

(1,24 ) (1,78 ) (1,24 ) (1,79 )
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CONDENSED STATEMENT OF CONSOLIDATED CASH FLOW

US GAAP IFRS
Year ended December 31, Year ended December 31,
In millions of USD 2022 2021 2022 2021
Net cash flows provided / (used) in operating activities

(55,7 ) (108,2 ) (51,4 ) (104,1 )
Net cash flows provided / (used) in investing activities

(0,1 ) (0,4 ) (0,1 ) (0,4 )
Net cash flows provided / (used) in financing activities

194,1 0,3 189,9 (3,9 )
Effect of exchange rate changes on cash & cash equivalents (US GAAP presentation)

(6,5 ) (10,7

Net increase / (decrease) in cash & cash equivalents

131,9 (119,1 ) 138,4 (108,4

Net cash & cash equivalents at the beginning of the period

77,3 196,4 77,3 196,4
Effect of exchange rate changes on cash & cash equivalents (IFRS presentation)

(6,5 ) (10,7

Net cash & cash equivalents at the end of the period

209,2 77,3 209,2 77,3

EPO Decision to Grant European Patent for Rencofilstat Further Strengthens Hepion’s Patent Portfolio

On March 2, 2023 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH"), fibrotic diseases, hepatocellular carcinoma ("HCC"), and other chronic diseases, reported that the European Patent Office ("EPO") has granted European Patent No. EP 3886813, covering the innovative formulation of Hepion’s lead cyclophilin inhibitor, rencofilstat (Press release, Hepion Pharmaceuticals, MAR 2, 2023, View Source [SID1234628081]).

The newly granted European patent also significantly extends the time period of Hepion’s patent exclusivity for rencofilstat. The Company’s original composition-of-matter patent estate, comprising 52 patents issued in every major market throughout the world, are expected to provide exclusivity to 2036. The newly granted rights, which will encompass 38 European countries, are expected to extend the drug candidate’s patent life by approximately eight years, to 2044. Additional filings are also underway to potentially extend composition-of-matter and method-of-manufacturing exclusivity until 2048. In addition to the indications covered in the original composition-of-matter patents (viral, cardiovascular, neurological, and inflammatory diseases), Hepion has also filed various method-of-use patent applications covering a variety of additional indications (fibrosis, cancer, and thrombosis).

Robert Foster, PharmD, PhD, Hepion’s Chief Executive Officer, stated, "Rencofilstat is very challenging to formulate, owing to the physical-chemical properties of the molecule. Nevertheless, as awareness of its potential to address a number of significant unmet medical needs across a variety of indications continues to grow amongst researchers and drug developers in global markets, it is important this opportunity is well protected. To that end, our expanding intellectual property estate, including this new European patent, should ensure that rencofilstat has long-term market exclusivity."

Porton Advanced Collaborates with DanausGT to Accelerate the Development of Gene and Cell Therapy

On March 2, 2023 Porton Advanced Solutions Ltd. (Porton Advanced) and DanausGT Biotechnology Co., Ltd. (DanausGT) reported on February 27, 2023, a strategic collaboration in gene and cell therapy pipelines to expedite the development of innovative therapeutics (Press release, Porton Advanced Solutions, MAR 2, 2023, View Source [SID1234628105]).

As an end-to-end gene and cell therapy service provider, Porton Advanced CDMO offers comprehensive solutions covering plasmids, cell therapy, gene therapy, oncolytic virus, mRNA therapy, and bacterial therapy. On the other hand, DanausGT focuses on researching, developing, and producing new anti-cancer drugs and rare diseases with gene editing technology. DanausGT has established multiple R&D pipelines, and Porton Advanced will offer gene and cell therapy CDMO solutions to DanausGT, including plasmid, virus, and cell therapy products.

"We are excited to partner with DanausGT as their proprietary CRISPR/AAV technology is widely recognized. Their seven research pipelines are highly competitive, covering all the stages from pre-clinical to Clinical Phase I. Through our end-to-end gene and cell therapy CDMO, we hope to help DanausGT achieve IND approval for multiple pipelines and advance the development pipeline from domestic and overseas into the clinical stage. This collaboration will accelerate the development of innovative CGT therapeutics," said Dr. Wang Yangzhou, CEO of Porton Advanced.

"We are pleased to establish strategic cooperation with Porton Advanced. I believe this partnership will expedite the development of innovative gene cell therapy. We are looking forward to collaborating in more fields," said Dr. Wang Haifeng, founder, and CEO of DanausGT.

During the signing ceremony, Professor Jose Carlos Segovia, co-founder and CSO of DanausGT, presented a lecture entitled "Ex Vivo Gene Editing as a Definitive Cure for Hemolytic Anemias" and introduced the latest research progress of DanausGT. "We make gene editing technology and cell therapy to treat various diseases and work on therapy development for patient-centered care and clinical value. We look forward to collaborating with Porton Advanced to bring innovative biopharmaceuticals to patients earlier and deliver innovative values to society and the industry," Professor Segovia said.

Children’s Hospital Los Angeles Develops Liquid Biopsy Test for Pediatric Solid Tumors

On March 2, 2023 Pediatric reported that solid tumors make up approximately 40% of all childhood cancers (Press release, Children’s Hospital Los Angeles, MAR 2, 2023, View Source [SID1234628104]). While pediatric cancer is rare, children can develop a wide range of tumor types, located in different parts of the body, which can make the differential diagnosis challenging. Investigators at Children’s Hospital Los Angeles have developed a liquid biopsy for solid tumors that has the potential to aid in reaching a specific diagnosis when surgery or a tissue biopsy is not feasible. The study findings were published on February 23 in the journal npj Precision Oncology.

"This is one of the first clinically validated liquid biopsy tests to be launched at a pediatric academic medical center," says Jaclyn Biegel, PhD, Chief of Genomic Medicine and Director of the Center for Personalized Medicine at CHLA.

"We created a test that may be helpful in making a diagnosis, determining prognosis, and potentially identifying an effective therapy for children with solid tumors," says Fariba Navid, MD, Medical Director of Clinical Research in the Cancer and Blood Disease Institute at CHLA. Dr. Navid and Dr. Biegel are co-senior authors of this study.

A specific test for pediatric tumors is required because the genetics of tumors that affect adults differ from those in children. Adult tumors tend to be caused by mutations—sequence-based changes in a gene—so most liquid biopsy tests have been developed specifically to identify these mutations. However, pediatric tumors arising from mutations are less common. In children, copy number changes—losing or having extra copies of one or more genes—or rearrangements of genes that result in gene fusions, are more characteristic. For their research study, the CHLA team combined a technique known as Low-Pass Whole Genome Sequencing (LP-WGS) with targeted sequencing of cell-free DNA from plasma to detect copy number changes, as well as mutations and gene fusions, that are characteristic of pediatric solid tumors. An important feature of the study was that it required a much smaller volume of sample than is required for liquid biopsy studies in adults. Since an infant or young child has a smaller blood volume, the assays needed to be scaled down to accommodate this difference.

To create the test, the researchers collaborated with clinical teams and research investigators at CHLA including Jesse Berry, MD, Director of Ocular Oncology and CHLA’s Retinoblastoma Program, as well as investigators involved in Oncology, Neurosurgery and Pathology and Laboratory Medicine. Leo Mascarenhas, MD, MS, Deputy Director of the Cancer and Blood Disease Institute at CHLA was also involved in the design and support of the project.

The first version of the test, launched in Nov. 2022, evaluates chromosomal copy number changes in blood samples, cerebrospinal fluid and the aqueous humor of the eye to aid in the clinical diagnosis for patients with solid tumors, brain tumors and retinoblastoma, respectively.

The next version of the clinical assay, available in about six months, will include detection of mutations and gene fusions.

The liquid biopsy-based genetic tests join the CHLA-developed OncoKids cancer panel, a next-generation sequencing-based assay designed to detect changes in DNA or RNA that are associated with pediatric leukemias, brain and solid tumors; the CHLA Cancer Predisposition Panel; RNAseq for cancer, a transcriptome-based assay using RNA sequencing; VMD4Kids, a panel for vascular and mosaic disorders; as well as methylation array-based profiling for pediatric brain tumors.

Eirini Christodoulou, PhD, and Venkata Yellapantula, PhD, both at CHLA, are co-lead authors on the study. Additional authors, all at CHLA, include: Jennifer Cotter MD, Xiaowu Gai PhD, Dejerianne Ostrow, PhD, and Moiz Bootwalla, MS, of the Department of Pathology and Laboratory Medicine; Katrina O’Halloran MD, James Amatruda MD, PhD, Anya Zdanowicz of the Cancer and Blood Disease Institute; and Liya Xu, PhD, of The Vision Center.

Natera Announces Commercial Payor Coverage for Signatera™

On March 2, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported the Company’s first commercial coverage policies for its molecular residual disease test, Signatera, including its first pan-cancer coverage policy for adjuvant, recurrence monitoring, and treatment monitoring (Press release, Natera, MAR 2, 2023, View Source [SID1234628103]).

Effective March 1, 2023, Blue Shield of California now provides commercial coverage of Signatera for plan members diagnosed with any solid tumors. Specifically, the policy describes tumor-informed ctDNA testing with Signatera as medically necessary for patients with stage I-IV cancer to provide information for (1) adjuvant or targeted therapy; and/or (2) monitoring for relapse or progression, including but not limited to the use of immunotherapy.

In addition, effective January 1, 2023, Blue Cross and Blue Shield of Louisiana is providing coverage of serial testing with Signatera for plan members diagnosed with colorectal and muscle invasive bladder cancer and for pan-cancer immunotherapy monitoring.

"Following the recent breast cancer coverage decision by Medicare, achieving our first commercial coverage policies for Signatera – including one that encompasses pan-cancer coverage – is another major milestone for Natera and the patients who will now have enhanced access to tumor-informed ctDNA testing," said John Fesko, chief business officer. "These developments underscore the medical necessity of Signatera to inform critical treatment decisions and detect recurrence earlier."

Data supporting the clinical validity and utility of Signatera has been published in approximately 40 peer-reviewed publications, including validation across multiple cancer types to detect recurrence earlier than standard diagnostic tools1,2 and to improve the assessment of treatment response in conjunction with imaging.3

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.

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DBV Technologies Reports Full Year 2022 Financial Results and Business Update

EPO Decision to Grant European Patent for Rencofilstat Further Strengthens Hepion’s Patent Portfolio

Porton Advanced Collaborates with DanausGT to Accelerate the Development of Gene and Cell Therapy

Children’s Hospital Los Angeles Develops Liquid Biopsy Test for Pediatric Solid Tumors

Natera Announces Commercial Payor Coverage for Signatera™