Full Press Release Details
DBV Technologies Announces Financing of up to $306.9 Million ( 284.5
Million) to Advance Viaskin Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch, if Approved
DBV Technologies (the Company or DBV ) (Euronext: DBV ISIN: FR0010417345 Nasdaq Capital Market: DBVT),
a clinical-stage biopharmaceutical company dedicated to treating pediatric allergies, today announced a financing of up to $306.9 million ( 284.5 million), including gross proceeds of
$125.5 million ( 116.3 million) to be received upon closing and an aggregate of up to ($181.4 million) ( 168.2 million) in gross
proceeds if all the warrants are exercised, subject to satisfaction of specified conditions. The VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of some of the warrants. DBV expects that the
proceeds of this funding will be used for working capital and general corporate purposes, to finance the continued development of the Viaskin Peanut program, to finance the preparation and submission of a potential Biologics License Application
( BLA ) and, to finance the readiness of a launch of Viaskin peanut in the US, if approved. The financing will result in an immediate dilution of 22.4% and a maximal dilution of up to 73.7% of existing shareholders (on a non-diluted basis) if all the warrants in the offering are exercised in full.
The financing was led by MPM
BioImpact, Adage Capital Management LP, Janus Henderson Investors, Vivo Capital, Octagon Capital, Surveyor Capital (a Citadel company), Bpifrance Participations, Yiheng Capital, as well as several large healthcare dedicated funds.
DBV is developing the Viaskin peanut patch for the treatment of pediatric peanut allergy. This injection of capital is coming on the heels
of news issued earlier this week announcing alignment with the FDA on safety exposure data required for a BLA for Viaskin peanut patch in 4
7-year-olds, accelerating the timeline for a BLA filing submission upon potential successful completion of VITESSE, said Daniel Tass , Chief Executive Officer, DBV
Technologies. I wish to again thank the FDA for their engagement and quick response. We are thrilled that this significant transaction will support our transition to a commercial organization as we progress towards completing the
required studies and start preparing the dossiers for FDA review and launch, if approved, for both Viaskin peanut patch indications in toddlers 1 3 and children 4 7 years-old.
I m pleased that we have an opportunity to get the Viaskin peanut patch to patients earlier
than planned. VITESSE is the largest study ever conducted for peanut allergy in this age range. We had tremendous interest in this study; our original plan to randomize 600 subjects increased to a final count of 654 due to a surge at the end
of recruitment, said Dr. Pharis Mohideen, Chief Medical Officer, DBV Technologies. This over-enrollment increases the study s statistical power to greater than 90% and therefore DBV s
probability of success for VITESSE. Further, we targeted a younger and more sensitive patient population by limiting the age to 4 7-year-olds and the entry eliciting dose for the food challenge to 100
mg these are the patients with a very high unmet medical need and who have historically seen robust treatment effects with Viaskin peanut. We ended up enrolling more younger subjects (i.e., 57% 4
5-year-olds) than expected and the overall study median peanut-specific IgE (39.2 kU/L) was also lower than expected, both of which have been associated with more robust treatment response1. We are looking forward to results in the fourth quarter of this year.
DBV looks forward to the continued advancement of the Viaskin peanut patch programs, highlighting the importance of the Company s strong
cash position with this newly secured capital, said Virginie Boucinha, Chief Finance Officer, DBV Technologies. We will continue to exercise diligent use of our resources. This infusion of capital from leading healthcare
investors both existing and new reflects a strong confidence in the importance of the Viaskin peanut patch, and its potential impact on food allergy families. We are pleased to have such high caliber investors supportive of DBV as we
progress towards potential commercialization of the Viaskin peanut patch, if approved.
The financing consists of:
1 Fleischer DM, et al. Presented at the annual meeting of the Western Society of Allergy,
Asthma & Immunology (WSAAI); Waimea, HI; February 9-13, 2025.
2 (i) natural person or legal entity, including company, trust, investment fund or other investment vehicle, regardless of their form, under French or foreign law, investing on a regular basis in
the pharmaceutical, biotechnological or medical technology sector, and/or (ii) French or foreign company, institutions or entities of any form, carrying out a significant portion of its business in the pharmaceutical, chemical, medical devices
or technology sectors or conducting research in these areas; and/or (iii) French or foreign investment service provider, or any foreign establishment with equivalent status, likely to guarantee the completion of an issue intended to be placed
with the persons referred to in (i) and/or (ii) above or in connection with the implementation of an equity or bond financing line and, in this context, to subscribe for the securities issued.
(together, the Offering ).
Reasons for the Issuance and Use of Proceeds of the Offering
The net proceeds from the issue of the ABSA and the PFW-BS-PFW, together
with existing cash and cash equivalents, will be mainly used in the following order of priority (i) for working capital and general corporate purposes, (ii) to finance the continued development of the Viaskin Peanut program, (iii) to
finance the preparation and submission of a potential BLA and, (iv) to finance the readiness of a launch of Viaskin peanut in the US, if approved.
As an indication, the aggregate net proceeds from the issue of the ABSA and the
PFW-BS-PFW (including the First Pre-Funded Price (as defined below) but excluding the exercise price of the First Pre-Funded Warrants, the ABSA Warrants, the BS Warrants and the Second Pre-Funded Warrants) is expected to be approximately
If all of the First Pre-Funded
Warrants, the BS Warrants, the Second Pre-Funded Warrants and the ABSA Warrants are exercised, the aggregate gross proceeds are estimated to be approximately
284.5 million (estimate aggregate maximum net proceeds of approximately 264.5 million).
Working Capital Statement
Company s current cash position (without giving effect to any potential proceeds from the Offering) is not sufficient to cover its operating needs for at least the next 12 months. As a result, there are significant uncertainties surrounding the
Company s ability to continue as a going concern.
On the basis of its current operations, plans and assumptions and prior to the Offering, the
Company expects that its cash and cash equivalents of 16.2 million at February 28, 2025 will be sufficient to fund its operations only into April 2025.
The Company estimates that (i) its net cash requirement for the next twelve months is approximately
102.4 million, and (ii) it will need an additional 86.2 million (excluding any potential proceeds from the Offering) to
supplement its working capital requirements and finance its operating expenses.
Taking into account the expected net proceeds from the issuance of
the ABSA and the PFW-BS-PFW and based on its current operations, plans and assumptions, the Company will have sufficient net working capital to meet its obligations over
the next 12 months, and will have sufficient cash and cash equivalents to fund its operations until June 2026.
The Company estimates that, following
the issuance of all the Warrant Shares, representing an aggregate gross proceed of up to 284.5 million, the Company could extend its financial visibility into 2028 and through potential
commercialization of Viaskin Peanut in the U.S, if approved.
These estimates are based on the Company s current business plan and excludes any additional
expenditures related to other programs than the Viaskin Peanut and Viaskin Milk programs or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may
pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.
If the Company is unable to meet its financing targets, it may have to scale back its activities, notably by delaying or reducing the scope of its
research and development efforts, or obtain financing through collaboration or other agreements, which could require the Company to relinquish rights to its product candidates, which the Company might otherwise seek to develop or market
independently or discontinue all or part of its activities.
Main Characteristics of the Offering
Subscription and Exercise Price
The ABSA and PFW-BS-PFW were issued by decision of the Company s Chief Executive Officer dated March 27, 2025, under and within the scope of the
sub-delegations of authority granted by the Company s Board of Directors on March 27, 2025 and in accordance with the 24th resolution of the 2024
General Meeting. The representative appointed by Baker Bros. Advisors LP and the representative of Bpifrance Participations SA to the Company s Board of Directors did not take part in the vote on the decisions at the meeting of the Board of
Directors held on March 27, 2025.
The subscription price of the ABSA (the ABSA Price ) is 1.1136 per ABSA ( 0.10 par value and 1.0136 issue premium). This ABSA Price includes the
fixed price per ABSA Warrant (i.e. the euro equivalent of $0.21875) required by the Nasdaq rules for each ABSA Warrant and shows a premium of 1.37% (excluding the ABSA fixed price and 23.89% including the ABSA fixed price) compared with the
volume-weighted average of the ordinary share price on the regulated market of Euronext in Paris ( Euronext Paris ) over five consecutive trading sessions out of the last 30 trading sessions preceding the setting of the price (i.e.
the sessions of March 13, 14, 17, 18 and 19 2025) (i.e. 0.8989) (the Reference Share Price ), and a 1.70% discount to this price including the theoretical value of 100% of
an ABSA Warrant. The theoretical value of an ABSA Warrant obtained using the Black-Scholes method is 0.23, with a volatility of 59.1%.
The exercise price per ABSA Warrant is equal to 1.5939, i.e. an amount corresponding to
(i) the ABSA Price less the fixed price per warrant of 0.2028 multiplied by (ii) one point seventy-five (1.75) (the ABSA Warrants Exercise Price ).
Given the specific characteristics of the PFW-BS-PFW, the price of a PFW-BS-PFW is equal to the ABSA Price and corresponds to the First Pre-Funded Price (as defined below) to be paid up on the date of
issue of the PFW-BS-PFW and to the balance of the exercise price of the First Pre-Funded Warrants equal to 0.01 to be paid up on the date of exercise of the First Pre-Funded Warrants.
The exercise price per BS Warrant is equal to
1.5764, i.e. the ABSA Warrants Exercise Price less 0.0175, and corresponds to the Second Pre-Funded
Price to be paid up on the date of issue of the Second Pre-Funded Warrants.
The exercise price per Second
Pre-Funded Warrant is equal to 0.0175 to be paid up on the date of exercise of the Second Pre-Funded Warrants.
Main Characteristics of the First Pre-Funded Warrants and the Second
The main feature of the First Pre-Funded
Warrants and the Second Pre-Funded Warrants is that their aggregate price, i.e. 1.1136 and 1.5939
respectively, is prefunded in the amount of 1.1036 (the First Pre-Funded Price ) and
1.5764 (the Second Pre-Funded Price and each of the First Pre-Funded Price and Second Pre-Funded Price, a Pre-Funded Price ) respectively (i.e. the relevant exercise price less (i) 0.01
for each First Pre-Funded Warrant or (ii) 0.0175 for each Second Pre-Funded Warrant) on their date of issue (at
the time of subscription) and not on their date of exercise. Payment of a Pre-Funded Price is final and irrevocable.
The First Pre-Funded Warrants and Second Pre-Funded Warrants are
exercisable in cash from their date of issue until April 7, 2035 (the Pre-Funded Warrant Exercise Period ).
The exercise of (i) one (1) First Pre-Funded Warrant will give the right to subscribe to one (1) First
PFW Share (the First Pre-Funded Warrant Exercise Ratio ) and (ii) one (1) Second Pre-Funded Warrant will give the right to subscribe to one point
seventy five (1.75) Second PFW Shares (the Second Pre-Funded Warrant Exercise Ratio ), in each case at an aggregate price of 1.1136 and 1.5939 per warrant respectively, it being specified that (i) as the exercise prices have been prefunded on the respective dates of issue of the First
Pre-Funded Warrants and the Second Pre-Funded Warrants up to the relevant Pre-Funded Price, only the balance (corresponding to an
amount equal to (i) 0.01 per First Pre-Funded Warrant and (ii) 0.0175 per Second Pre-Funded Warrant) will have to be paid up on the date on which the First Pre-Funded Warrants and the Second Pre-Funded Warrants are
exercised, and (ii) the First Pre-Funded Warrant Exercise Ratio and the Second Pre-Funded Warrant Exercise Ratio may be adjusted following any transactions carried
out by the Company involving its share capital or reserves in order to maintain the rights of the holders of the First Pre-Funded Warrants and the Second Pre-Funded
Warrants, in accordance with applicable regulations.
No fractional shares shall be issuable upon the exercise of First Pre-Funded Warrant and Second Pre-Funded Warrants, provided that the number of shares to be delivered in respect of any exercise of one or more First Pre-Funded Warrants or Second Pre-Funded Warrants pursuant to any exercise notice shall be rounded down to the nearest whole multiple of one share.