Sanionas vd: momentum för Tesomet i två sällsynta sjukdomar
Den 21 september 2020 avslutas nyttjandeperioden för Sanionas teckningsoptioner av serie TO 2 som kan stärka bolaget med cirka 37 Mkr före emissionskostnader. Innehavare av TO2 äger rätt att för varje teckningsoption teckna en ny aktie i Saniona till en kurs om 25 SEK per aktie. För BioStock berättar Sanionas vd Rami Levin att befintlig kliniska data pekar på att man kommer att nå marknad med läkemedelskandidaten Tesomet inom två sällsynta ätstörningssjukdomar.
Den 10 januari klubbade bioteknikbolaget Saniona igenom en omfattande finansieringsplan om upp till 158 Mkr. En del i denna finansieringslösning utgjordes av två teckningsoptioner, varav den första – TO 1 – genomfördes i maj och inbringade 24 Mkr.
Fram till den 21 september 2020 pågår nyttjandeperioden för den andra teckningsoptionen – TO 2 – som kan tillföra bolaget ytterligare 37 Mkr.
I juni genomfördes dessutom en riktad emission varigenom Saniona erhöll en bruttolikvid om 65 miljoner USD (cirka 567 Mkr). RA Capital Management agerade ankarinvesterare i den riktade emissionen, som även tecknades av bland annat Pontifax Venture Capital och New Leaf Venture Partners tillsammans med andra amerikanska och internationella sektorspecialister samt de svenska pensionsfonderna Andra AP-fonden (AP2), Tredje AP-fonden (AP3) och Fjärde AP-fonden (AP4).
Utöver detta tog bolaget den 22 juni även in 22 Mkr (2,3 MUSD) genom försäljning av aktier i Scandion Oncology, ett bolag som tidigare knoppats av från Saniona.
Finansieringen understödjer kliniskt avancemang
Styrkta av denna finansiering ser manegen nu ut att vara krattad för att avancera den primära läkemedelskandidaten Tesomet till registrering och marknadsgodkännande av världens första behandlingar för de två sällsynta sjukdomarna hypotalamisk fetma och Prader-Willis syndrom.
Ett annat viktigt mål, parallellt med att accelerera bolagets kliniska projekt, är att attrahera kompetenta individer till nyckelpositioner på det nya huvudkontoret i Boston. Den 24 augusti stod det klart att ledningsgruppen utökas med tre branschveteraner. Jason A. Amello tillträder rollen som ny Chief Financial Officer, Trista Morrison blir Chief Communications Officer och Linea Aspesi blir ny Chief Human Resources Officer. Samtliga kommer att ingå i Sanionas ledningsgrupp. Läs mer här.
Teckningsoptioner av serie TO 2 i sammandrag
Den nu aktuella teckningsoptionen, vars teckningsperiod löper mellan 7 och 21 september, kan sammanfattas enligt nedan.
- Teckningskurs: Varje teckningsoption av serie TO 2 ger innehavaren rätt att teckna en (1) ny aktie i Saniona till en kurs om 25,00 SEK.
- Emissionsvolym: Vid fullt nyttjande av samtliga teckningsoptioner av serie TO 2 tillförs Saniona cirka 37 MSEK före emissionskostnader.
- Värdering (pre-money): Cirka 1 526 MSEK.
- För att teckningsoptionerna inte ska förfalla krävs att de utnyttjas eller säljs senast klockan 17:00 CEST den 21 september 2020.
Folder och informationsblad hålls tillgängliga här.
Vd kommenterar
BioStock kontaktade Sanionas vd Rami Levin för en kommentar kring hans syn på framgångschanserna med Tesomet när man nu närmar sig marknadsförberedande fas III-studier.
Rami Levin, you entered 2020 with a comprehensive financing plan. How much capital do you estimate it will take to take Tesomet all the way to market in hypothalamic obesity (HO) and Prader-Willi syndrome (PWS) respectively?
– As you noted, Saniona has recently been able to access a significant amount of capital through our USD 65 million (approximately SEK 567 million) private placement, and also through the exercise of warrants and the sale of shares in our Scandion Oncology spin-out. This financing will allow us to advance Tesomet to registration for approval in hypothalamic obesity (HO) and Prader-Willi syndrome (PWS), and also to move our early-stage pipeline into the clinic and build our organization in the US.
– We are already making significant progress on each of these goals, and we believe this progress will create significant value for patients and for shareholders.
In June, you carried out a large-scale private placement with a discount of 45 percent, where you received approximately SEK 567 million. The other day it was announced that one of these institutional investors, the Second AP Fund, had sold between half and two thirds of the 1.9 million shares they bought. The reason for the sale, which pushed the share price down 22 percent in one month, was stated to be that the fund had gained too much weight in Swedish shares. what are your thoughts on this?
– The primary reason we carried out the large-scale private placement was to provide Saniona with the capital needed to advance clinical trials of Tesomet and our other potential treatments for rare diseases. This goal was successfully achieved. Another very important motivator for the financing was the opportunity to strengthen our shareholder base with experienced, healthcare-focused institutional investors who believe in the value Saniona can create over the long term.
– This goal was also achieved. Of course we are disappointed to have later learned that AP2 have ultimately decided to sell some of their shares. This is contrary to what we were led to believe by inviting them into the capital raise. Having said that, I am very pleased with the quality of investors who participated in our recent financing, and from our discussions I believe that they see the long term value potential in Saniona.
Do you have an ongoing dialogue with the new investors? What is attracting them with the Saniona story?
– I communicate frequently with investors through conference presentations, press releases, meetings, phone calls and emails. During the recent private placement, as well as post the deal I had the opportunity to meet with many investors, and I was very encouraged to see their enthusiasm for the work we are doing at Saniona. In particular, they see the unmet need in HO and PWS, and they are encouraged by the data from our Phase 2 trials of Tesomet in these indications. They also expressed significant optimism for our earlier stage pipeline programs.
– Moving forward, I look forward to enhancing our investor communications with the support of the growing Saniona team. I recently hired Trista Morrison as Chief Communications Officer, and a significant area of focus for her will be ensuring that we communicate effectively and transparently. Additionally, I recently hired Jason Amello as Chief Financial Officer, and he will help ensure that we are specifically making information understandable and accessable to the investor community.
»We have been engaging in encouraging discussions with the FDA regarding the design of our pivotal programs. We expect to initiate these studies in Q1 2021, with the goal of bringing to market the first approved medicine to treat these diseases« – Rami Levin, CEO Saniona
You are approaching the crucial pivotal studies within the two primary indications HO and PWS – two diseases where there are currently no treatment options. What do the clinical data you have today suggest about the candidate’s potential chances of success?
– Our Phase 2 studies in hypothalamic obesity (HO) and Prader-Willi syndrome (PWS) both achieved their endpoints. In HO, Tesomet was safe and well tolerated, with statistically significant improvements in body weight, waist circumference, and glycemic control observed with Tesomet treatment compared to placebo. In PWS, Tesomet was also safe and well-tolerated. In adult patients, Tesomet provided clinically meaningful weight loss and a significant reduction in hyperphagia. In adolescent patients, Tesomet demonstrated a dose dependent effect on weight and hyperphagia.
– Based on these data, we have been engaging in encouraging discussions with the FDA regarding the design of our pivotal programs. We expect to initiate these studies in Q1 2021, with the goal of bringing to market the first approved medicine to treat these diseases,
In conclusion, how convinced are you that you will succeed in taking Tesomet all the way to the patients, and why?
– Hypothalamic obesity (HO) and Prader-Willi syndrome (PWS) are very difficult diseases to treat. Discovering and developing new medicines for diseases like this is incredibly difficult, and there are no guarantees. That said, the reason I joined Saniona in January – and the reason we keep recruiting experienced executives to our team – is that we see the data with Tesomet and we believe we have a chance to make a difference in the lives of these patients and their families.
Innehållet i BioStocks nyheter och analyser är oberoende men BioStocks verksamhet är i viss mån finansierad av bolag i branschen. Detta inlägg avser ett bolag som BioStock erhållit finansiering från.
