Spotlight-noterade Carbiotix rapporterade för tredje kvartalet 2022, en period där fokus har legat på GRAS-godkännande, produktion av CarbioAXOS, försäljnings- och partneringaktiviteter, pågående patientstudie, och IP-portföljen. BioStock kontaktade vd Kristofer Cook, som nyligen hemkommen från USA, kommenterade de senaste händelserna och utsikterna framåt.

Lundabolaget Carbiotix utvecklar och tillverkar nästa generation prebiotiska modulatorer, CarbiAXOS, som kan användas som ingrediens i livsmedel, kosttillskott, medicinsk mat och i terapeutiska behandlingar. Prebiotiska fibrer ger en bättre maghälsa och kan förebygga sjukdomar genom att ge föda åt goda bakterier i tarmen.

Carbiotix har även utvecklat LinkGut, en B2B-tjänst som är riktad till bolag som vill erbjuda sina användare en laboratoriebaserad analys av hälsotillståndet i magen.

Carbiotix rapporterar Q3

Det Spotlight-noterade bolaget publicerade nyligen sin delårsrapport för det tredje kvartalet 2022. Bolaget redovisade en rörelseförlust om 2,5 Mkr, jämfört med en förlust om 2,1 Mkr under samma period 2021. Bolagets kassa vid kvartalets utgång uppgick till 10,4 Mkr.

Under Q3 har Carbiotix även meddelat att styrelseledamoten Peter Falck sålt aktier i bolaget och passerat flaggningsgränsen om 15 procent. Falck lämnade i våras sin roll som CSO men sitter kvar i styrelsen och fungerar som senior rådgivare till Carbiotix. Avyttringen av aktierna innebar att Falck minskat sitt innehav från 15,04 procent till 13,96 procent.

GRAS-godkännande

Under tredje kvartalet meddelade Carbiotix att USA-lanseringen av CarbiAXOS förskjutits något p.g.a. att ett viktigt enzym från tredje part som används i tillverkningen, fick GRAS-godkännande först i september. Godkännandet är ett krav för att kunna lansera CarbiAXOS som ingrediens i livsmedel i USA. Enligt bolaget ska inte förseningen påverka den planerade lanseringen i november nämnvärt. Läs mer.

Utreder snabbare uppskalning

Carbiotix har också uppdaterat om uppskalning av produktionen av CarbiAXOS med bakgrund av det svåra makroekonomiska läget. Bolaget har utforskat olika alternativ för att optimera tillverkningsprocesserna och hålla nere kostnaderna.

Ett alternativ som bolaget kommunicerat är användningen av kontraktstillverkare, som snabbare kan skala upp bolagets produktion och undvika investeringar på kort sikt, enligt vd Kristofer Cook i en intervju med BioStock.

Framsteg i patientrekrytering till klinisk studie

Carbiotix rapporterar även framsteg i bolagets första kliniska studie där CarbiAXOS medicinska mat prövas i kombination med standardbehandlingen metformin i typ 2-diabetes. Patientrekryteringen till studien vid Lunds universitet har fortskridit under tredje kvartalet efter vissa förseningar och bolaget meddelade att interventionsfasen bör kunna inledas under Q4.

Vd kommenterar

BioStock kontaktade vd Kristofer Cook för en kommentar kring Q3-rapporten och för att få veta mer om utvecklingsplanerna.

Kristofer, the Q3 report shows that you have a cash position of just over 10 MSEK, what can you say about the financial planning going forward?

– While we will monitor our costs very closely to ensure that the company has adequate liquidity to continue with its activities going forward, no decision has been made to date regarding further financing. We will of course closely monitor share price development and market sentiment over the next 6-9 months to assess any impact on the current warrant program (TO 1) and take appropriate action if we feel that there is a deviation from the current financing plan.

How are you proceeding with your planned launch of CarbiAXOS in the US?

– We successfully revealed CarbiAXOS to the US market in Boston this past week at the Microbiome Movement – Human Nutrition Summit. This event marked the start of pre-sale activities, and we are now following up on the contacts made. Overall, I am very pleased by the level of interest in CarbiAXOS as well as our LinkGut service as a door opener to potential CarviAXOS customers. During our trip to the US, we also began planning for exhibiting at next year’s Supply Side West tradeshow in Las Vegas, also meeting key potential partners who could assist with ramping up sales activities.

You previously mentioned that Carbiotix explored the use of contract manufacturers, with ongoing due diligence in the US. Can you give an update about that process?

– During our recent trip to the US was also met with potential contract manufacturers of CarbiAXOS. I am happy to communicate that our due diligence site visits went very well, and I hope to announce an agreement in the coming months. Again, the rationale of working with contract manufacturers is many-fold and includes faster scale-up, lower cap-ex, and improved carbon footprint. Our production site in Bjuv will of course not be idle and continue to be used for accelerating R&D activities, producing product samples for testing and formulation work, and the manufacturing of non-food products in the short-term until our European regulatory approvals are in place.

Could you give us an update regarding LinkGut and new partners for the B2B service?

– Our first LinkGut partner recently relaunched their service which should result in top line growth of the LinkGut service going forward. We see that our other partners are also accelerating their market launch activities and see very good interest in the LinkGut service. This should allow to meet our goals regarding new partner sign ups. This interest was further confirmed during our trip to the US, with multiple potential partner discussions as a follow up. It is clear that LinkGut will be a door opener for CarbiAXOS across modulator classes.

– The trend towards increased personalisation and the long-term monitoring of gut health means that LinkGut is very well positioned to capture this growth as we offer the most cost effective, flexible and reliable service on the market today for companies wanting to offer their own gut health or microbiome test.

What is the status of the Carbiotix’ IP portfolio and planned IP activities?

– As we recently communicated, we are in the process of abandoning two patents that were submitted when Carbiotix was a business-to-consumer company. Since our decision to focus exclusively on business-to-business transactions, these patents made no sense to pursue. We will instead refocus these resources on applying for patents related to our modulators, especially regarding our medical food and therapeutic co-interventions. This decision makes both business and economic sense.

Looking ahead, what milestones do expect to reach in the coming months?

– We have many parallel activities going on at Carbiotix. The most important milestone is of course the completion of our GRAS Self Affirmation process, and we are working very hard to complete this as soon as possible. This process is however not impacting our ability to proceed with pre-sales.

– Other key milestones include the signing of a contract manufacturer in the US as mentioned, signing on and launching additional LinkGut partners, further IP in the modulator space, the presentation of results from different studies, and accelerating R&D activities leading to new products from different substrate materials. From my perspective, things are coming together very nicely and should lead to both the acceleration of new products and sales.

– Moreover, although we are in uncertain macroeconomic times, it is comforting to know that Carbiotix value proposition is very strong, and its target market(s) should experience good growth in the coming years.

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