On October 15, 2021 MaaT Pharma S.A. (" MaaT Pharma " or the "Company"), a French clinical stage biotech and a pioneer in the development of microbiome[1] based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, reported the launch of its initial public offering on the regulated market of Euronext in Paris (code ISIN : FR0012634822- ticker code : MAAT) (Press release, MaaT Pharma, OCT 15, 2021, View Source [SID1234591287]). On October 14, 2021, the French Autorité des Marchés Financiers (AMF) approved the Prospectus under number 21-445 consisting of a Registration Document approved on October 1, 2021, under the number I.21-057, the supplement of the registration document approved on October 14, 2021 under number I.21 061, a Securities Note and a summary of the Prospectus (included in the Securities Note).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Hervé Affagard, Co-founder and CEO of MaaT Pharma, said:
"MaaT Pharma aims to change the global pharmaceutical industry by developing next-generation drugs based on complete microbiome ecosystems. While 25% of the world’s population suffers from an altered gut microbiota, our clinical data show that its restoration could play a major role in improving the survival outcomes for patients with acute Graft-versus-Host Disease (following a bone marrow transplant) as well as for patients fighting other liquid and solid tumors. Our proposed IPO comes at a pivotal time in our history, as first key development milestones have been achieved, with promising Phase II clinical results and the launch of a Phase III trial planned before year end. I hope that our project will attract new institutional and individual shareholders to support us in the execution of our ambitious strategy, which first and foremost aims to address major public health issues for the benefit of millions of patients."
An innovative therapeutic approach based on microbiome modulation to improve survival in patients with liquid and solid tumors
The gut microbiota is an assembly of rich and diverse microorganisms ("ecosystem") and contributes to maintaining a symbiosis[2] between the host and the billions of naturally present microbes in the human body. This symbiosis is essential for human health and regulates our immune homeostasis, as 80% of immune cells reside in the intestine[3], and our metabolism. A balanced symbiosis generates protection through a stronger intestinal barrier and contributes to the education and maturation of the immune system against potential pathogens. However, lifestyle, diet, or the use of toxic drugs for the microbiome can alter this symbiosis. This alteration is referred as "dysbiosis" and is notably illustrated by a loss of diversity of microorganisms. This condition represents a danger for the host because bacteria could induce deleterious, inflammatory reactions or make anti-cancer treatments less effective.
To address significant unmet medical needs in oncology, MaaT Pharma is designing an innovative therapeutic approach based on gut microbiome modulation. The company develops high-richness and high-diversity drug candidates derived from healthy donors or produced by co-fermentation, using its MET (Microbiome Ecosystem Therapy) platform.
MaaT Pharma’s lead drug candidates are:
MaaT013 for the treatment of acute Graft-versus-Host Disease (aGvHD), ready to enter Phase III trial in the EU[4] (application of the clinical trial submitted). MaaT013 is also expected to enter a Phase II proof of concept trial to evaluate its impact on response rates to immune checkpoint inhibitors in treatment-naïve metastatic melanoma.
MaaT033 for the improvement of survival in patients with acute myeloid leukemia (AML) or other liquid tumors receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT), currently in a Phase Ib trial.
MaaT03X, a new generation of co-fermented microbiome-based therapies to be used in combination with immuno-therapy in oncology, targeting solid tumors. The MaaT03X line is currently in preclinical testing.
[1]The microbiome (also called intestinal flora) refers to all the microorganisms (bacteria, archaea, yeasts, viruses…) naturally present in the intestine. It plays a major role in the education and modulation of the immune system and in the metabolism.
[2] Symbiosis: mutually beneficial relationship
[3] Castro G.A. & Charles J.A., Am. J. Physiol. 265 (Gastrointest. Liver Physiol. 28): G599-G610, 1993.
[4] Expansion to US sites in H2 2022 subject to lifting of FDA clinical hold
An ambitious development strategy
In a market with a strong potential and offering multiple opportunities for the Company, MaaT Pharma intends to pursue an ambitious strategy articulated around four major points:
Focus its development on microbiome modulation in oncology (both liquid and solid tumors) in indications with high unmet medical need, to maximize its expertise and consolidate its pioneer status in the microbiome field, while preserving its competitive advantage;
Gradually expand its product pipeline by discovering new innovative microbiome-based therapiesin hemato-oncology and immuno-oncology, leveraging its internal expertise and its proprietary technology platform. The Company’s proprietary technology platform enables to use pre-existing clinical data to significantly accelerate new drug development and reduce associated risks. The combination of gutPrint with proprietary and exclusive cGMP manufacturing processes is used as a cornerstone to strengthen and expand the Company’s portfolio;
Build an integrated biopharmaceutical company, which could on the one hand ultimately commercialize its most advanced products, thanks to the limited number of specialized hospital centers performing allo-HSCT and on the other hand establish potential collaboration agreements with one or more larger pharmaceutical partners, to develop and/or commercialize new drug candidates generated using its MET platform;
Collaborate closely with regulatory agencies to enable efficient development of a new treatment modality in this pioneering field. Since 2014, MaaT Pharma has received approval to start multiple clinical trials from the ANSM and other European agencies; MaaT013 also received Orphan Drug Designation from both the FDA and EMA in 2018. Since 2018, the French regulator ANSM has enabled access to MaaT013 in aGvHD through a compassionate use (ex-« ATU nominative ») program.
An initial public offering on the regulated market of Euronext in Paris for financing growth and development
MaaT Pharma’s initial public offering is intended to provide the Company with the necessary financial resources to implement its development strategy and accelerate its growth.
Estimated net proceeds of the offering in the context of this transaction (amounting to €31.5m which may be increased to €42.0 m in the event of full exercise of the extension clause and the over-allotment option)[1] will enable MaaT Pharma to pursue the following objectives:
nearly 2/3 for the company’s clinical programs, including the Phase III of MaaT013, initiation of Phase II/III of MaaT033 and preparatory works for Phase I of MaaT03X, including current expenditure related to these activities;
over a third for industrial scale-up of MaaT013, MaaT033 and MaaT03X production including lump sum payments related to the building of modular buildings for pharmaceutical use and associated process equipment and current expenditures related to these activities.
The Company has received subscription commitments up of €17.9m from historical and current shareholders
The Company has received subscription commitments of approximately €17.9m (i.e. approximately 51.2% of the amount of the initial offering based on the mid-point of the indicative price range), at any price within the price range of the Offering, from historical investors:
Investors Subscription undertakings in cash
Seventure Partners (Health for Life Capital) €4.9m
SymBiosis €4.6m
Biocodex €2.3m
Bpifrance €2.5m
Crédit Mutuel Innovation €3.0m
Skyviews €0.4m
Celeste €0.3m
In addition, Eurekare, a company focused on financing biotechnology companies in the fields of the microbiome and synthetic biology, has made a commitment to place an order of €1.0 million.
[1] Based on the midpoint of the indicative price range.
Eligibility of the offering for the PEA and PEA-PME
MaaT Pharma announces that it fulfils the eligibility criteria for the PEA-PME scheme provided under Articles L.221-32-2 and D.221-113-5 et seq. of the French Monetary and Financial Code. Therefore, the shares of MaaT Pharma can be fully integrated into equity savings plans (plans d’épargne en actions, PEA) and PEA-PME accounts, which benefit from the same tax benefits as the classic PEA.
Availability of the prospectus
The registration document of the Company approved by the AMF on October 1, 2021, under the number I.21-057, the supplement of the registration document approved by the AMF on October 14, 2021, under the number I.21-061, the security notes and the summary of the prospectus are available free of charge and on simple request from MaaT Pharma and on the following websites: www.amf-france.org and investir.maatpharma.com. The approval of the Prospectus should not be considered as an endorsement on the securities offered or admitted to trading on the regulated market of Euronext Paris.
Risk factors
The Company draws the public’s attention to the risk factors described in Chapter 3 of the Registration Document approved by the AMF and the Chapter 3 of the supplement of the registration document approved by the AMF, as well as Section 2 « Facteurs de risques de marché pouvant influer sensiblement sur les valeurs mobilières offertes » of the Securities Note. Potential investors are invited to read the prospectus before making an investment decision in order to fully understand the potential risks and rewards associated with the decision to invest in the Company’s securities. The occurrence of one or more of these risks may have a material adverse effect on the business, results, financial conditions and prospects of the Company and on the value of its securities.
Net working capital
The Company draws the public’s attention to the fact that:
The Company does not have sufficient net working capital to meet its commitments and operating cashflow needs for the next twelve months. The cash and cash equivalents available to it as of August 31, 2021, i.e., of €15.3m, will enable it to cover its cash requirements until the end of the first quarter of 2022, taking into account the first payment of €478,498 of a €1,913,993 grant from Bpifrance granted in July 2021 and unavoidable inherent costs incurred by the Company in the context of the public offering whether it occurs or not, of around €1.1m;
The additional funding required to continue operations in accordance with the business plan as described herein for the twelve-month period following the approval of the prospectus by the AMF is estimated to be €15m from April 2022 to end of October 2022. This amount includes (i) operating expenses for the period concerned (ii) debt financing repayments of 0.7 million euros(iii) lump sum payments related to the construction of modular pharmaceutical buildings complying with cGMP regulations, as defined in the term sheet signed with Skyepharma on September 30, 2021, and the acquisition of process equipment by the Company, totalling €3.0m;
This amount of €15m will be funded from the net proceeds from the Offering amounting to €5m (on the basis of a capital increase subscribed at 100% at the median price, net of estimated fees associated with the Offering), which will enable the Company to continue operations until the end of the third quarter of 2023.
Should the capital increase be subscribed at 75% and at the low-end of the price range of €13.50 per share, i.e., €20.6m (net of the incompressible costs inherent to the initial public offering project), the Company will proceed with certain modifications described under note 3.4 of the Prospectus in order to pursue key activities and projects.
Financial intermediaries and advisors
Find all the information relative to the project of MaaT Pharma’s IPO on:
View Source
MAIN TERMS AND CONDITIONS OF THE TRANSACTION
SHARE CAPITAL BEFORE THE TRANSACTION
Société anonyme à conseil d’administration (French corporation), with share capital of €671,332 divided into 6,713,320 shares of €0.10 each.
CHARACTERISTICS OF THE SHARE
Label: MAAT PHARMA
Mnemonic code: MAAT
ISIN code: FR0012634822
Listing market: Euronext Paris
ICB Classification: 20103010 – Biotechnology
LEI: 969500CQQB6XUNW6CN97
Eligibility for PEA "PME-ETI" scheme [1]
INDICATIVE PRICE RANGE
Between €13.50 and €16.50 per new share, as decided by the board of directors on October 14, 2021. This information is given purely for information purposes and should not, in any circumstances, be considered an indication of the offering price, which may be set outside this indicative range.
INITIAL SIZE OF THE OFFERING
All the existing ordinary shares of the Company comprising the Company’s share capital will be admitted to trading. The Offering shall be carried out through the issuance of 2,333,333 new shares (corresponding, on an indicative basis, to an amount of €35.0m, issue premium included)[2] which may be increased to a maximum amount of 2,683,332 new shares in the event that the Extension Clause is exercised in full, representing up to 15% of the number of new shares.
OVER-ALLOTMENT OPTION
In order to cover possible over-allotments, the Company will grant to Portzamparc (the "Stabilizing Agent"), in the name and on behalf of the Joint Global coordinators and Joint bookrunners, an option allowing the acquisition of a number of shares representing a maximum of 15 % of the cumulated number of new shares that may result from the possible exercise of the Extension Clause, i.e., a maximum of 402,499 additional shares sold, thus facilitating the stabilization transactions (the "Over-Allotment Option").
This Over-Allotment Option may be exercised, in whole or in part, at the offering price, once at any time by the Stabilizing Agent, in the name and on behalf of the global coordinators and associated bookrunners, as from the determination of the offering price and until the 30th calendar day following the start of the trading of the shares of the Company on Euronext in Paris, i.e. from November 8, 2021 until December 8, 2021 inclusive, and carry out stabilization transactions in order to stabilize or support the price of the shares of the Company on the regulated market of Euronext in Paris within the limit of the Offering price, in accordance with the applicable legal and regulatory provisions (in particular those of Regulation (EU) No. 596/2014 of the European Parliament and of the Council as supplemented by Delegated Regulation No. 2016/1052 of the European Commission of March 8, 2016.
In the event of the exercise of the Over-Allotment Option, this information will be disclosed to the public by means of a press release issued by the Company.
GROSS AMOUNT OF THE TRANSACTION
An amount of approximately €35.0m which may be increased to approximately € 40.2m in the event of full exercise of the Extension Clause and to an amount of approximately €46.3m in the event that the Extension Clause and the Over-Allotment Option (based on the mid-point of the indicative price range) are fully exercised.
NET PROCEEDS OF THE ISSUE
A net amount of approximately €31.5m which may be increased to approximately €36.3m in the event of full exercise of the Extension Clause and to an amount of approximately €42.0m in the event that the Extension Clause and the Over-Allotment Option (based on the mid-point of the indicative price range) are fully exercised.
[1] This scheme is conditional and within the limits of the available ceilings. Those interested are asked to contact their financial advisor.
[2] Based on the midpoint of the indicative price range
STRUCTURE OF THE OFFERING
It is envisaged that the offering of new shares will be distributed as part of a global offering (the "Offering"), which shall include:
a public offering in France in the form of an open price offering, mainly intended towards individuals (the "Open Price Offering" or " OPO"), being specified that:
the orders will be broken down according to the number of shares requested: A1 Order fraction (from 1 share up to and including 200 shares) and A2 Order fraction (over 200 shares);
the A1 Order fractions will benefit from preferential treatment compared to the A2 Order fractions in the event that all orders cannot be fully satisfied.
A Global Placement mainly to institutional investors (the "Global Placement") comprising:
a private placement in France; and
an international private placement in certain countries, outside, in particular, the United States, Japan, Canada and Australia
Consequently, if demand for the OPO so permits, the number of shares allocated in response to orders issued as part of the OPO will be at least equal to 10% of the number of Offered Shares as part of the Offering (before any exercise of the Extension Clause and the Over-Allotment Option).
REVOCATION OF SUBSCRIPTION ORDERS
The subscription orders placed online within the Open Price Offering will be revocable. Each financial intermediary determines the conditions under which orders transmitted may be revoked. It is therefore up to the investors wishing to revoke their orders to contact their financial intermediary.
Any order placed within the Global Placement may be revoked with the financial intermediary having received this order until November 3, 2021, at 12:00 p.m. (Paris time), unless the Global Placement is closed earlier or extended.
LOCK UP COMMITMENTS
Lock-up commitment by the Company: 180
Lock-up commitment for historical shareholders of the Company: 180
Lock-up commitment for management and employees: 180
SUBSCRIPTION UNDERTAKINGS
The Company has received subscription undertakings in the amount of € 17.9m (i.e. approximately 51.2% of the amount of the initial Offering based on the midpoint of the indicative price range of the Offering and around 76% of the amount of the initial Offering subscribed at the low end of the indicative price range of the offering), at any price within the price range of the Offering, from:
Funds managed by Seventure Partners SA for an amount of €9m;
SymBiosis, LLC for an amount of €6m;
Biocodex SAS for an amount of €3m;
Bpifrance for an amount of €5m, via the PSIM Fund;
Crédit Mutuel Innovation for an amount of €0m;
Céleste Management SA for an amount of €3m;
Skyviews Life Science Ltd. €4m.
In addition, Eurekare, a company focused on financing biotechnology companies in the field of the microbiome and synthetic biology, has made a commitment to place an order of approximately €1m.