MAIA Biotechnology: Progress In The THIO-101 Trial Sets Up A 2023 Catalyst (NYSE:MAIA)

MAIA Biotechnology (NYSE:MAIA) is growing 6-thio-2′-deoxyguanosine (6-thio-dG), a telomere focusing on agent, for quite a lot of cancers. A current replace on the corporate’s scientific trial and fundraising by the corporate are positives which have made the identify value writing about.

MAIA’s THIO-101 trial

MAIA’s THIO-101 trial recruits stage III or IV non-small cell lung most cancers (NSCLC) sufferers, who’ve relapsed or progressed following therapy with an immune checkpoint inhibitor, and treats them with 6-thio-dG together with the immune checkpoint inhibitor cemiplimab (Libtayo). Libtayo is at present marketed by Regeneron (REGN), who MAIA have a scientific provide settlement with.

Though THIO-101 enrolls sufferers which have already relapsed or progressed following therapy with a checkpoint inhibitor, MAIA’s 6-thio-dG has an immunogenic impact that may work in live performance with checkpoint inhibitors (which have an identical however complementary motion) to assist a sufferers immune system acknowledge and direct an assault towards tumor cells.

Some progress within the THIO-101 trial

Whereas MAIA started dosing sufferers in July 2022 in its THIO-101 trial in Australia, a June 20 press launch from MAIA notes the opening of 13 trial websites in Europe in 2023. These new websites have allowed the corporate to greater than double enrolment in a brief period of time, with 29 sufferers now enrolled.

“With speedy enrollment within the trial, we venture a considerable variety of sufferers finishing 3-6 months of therapy by the autumn which can enable us a preliminary analysis of the therapy efficacy”

Mihail Obrocea, MD, MAIA’s Chief Medical Officer.

I am upbeat concerning the price of enrolment of the trial regardless of solely enrolling 29 of the eventual 184 deliberate sufferers, since I’d anticipate half A of the research, which is now full, to maneuver extra slowly as MAIA took time to gather trendy security knowledge (6-thio-dG was trialed at a lot larger doses within the 70’s, when checkpoint inhibitors did not exist) and generate curiosity within the trial. Additional MAIA nonetheless plans to open two extra websites in Europe.

Exterior of Europe and Australia, MAIA plans to submit an Investigational New Drug (IND) software in 2023 to the US Meals and Drug Administration (FDA) so it might start operating the THIO-101 research at websites within the US as effectively. MAIA held a pre-IND assembly with the FDA in 2022, and was planning on the time to submit an IND in H1’23 and start enrolling within the US in H2’23. A 2023 Company Abstract on MAIA’s web site, up to date in early June 2023, nonetheless lists a 2023 time line for enrolling sufferers within the US in THIO-101, so it would not appear to be there was any slippage within the timeline because the pre-IND assembly in late 2022.

MAIA already notes that the primary two sufferers within the THIO-101 research, that have been recruited in Half A of the research, are nonetheless development free six and 7 months after stopping therapy, and nonetheless surviving at 10 and 11 months after starting therapy.

These two sufferers had stage IV NSCLC and are receiving third and fourth-line therapy. If we take MAIA’s phrase for it that these sufferers usually survive for simply 3-4 months, then we may already say there are hints of efficacy for 6-thio-dG. I need to see some knowledge from a bigger variety of sufferers earlier than we strive to attract very exact comparisons to historic knowledge or particular survival numbers from different trials in refractory NSCLC sufferers. Simply eyeballing that comparability proper now nevertheless, I can see how if MAIA continues to see sufferers surviving that lengthy, an replace in a bigger variety of sufferers would possibly get the market excited. That’s, even when scientifically I remained skeptical about that comparability throughout trials, from a buying and selling viewpoint, I feel the inventory may rally. I feel many biotech traders is perhaps tempted to take a look at 10 months or extra of general survival in refractory NSCLC sufferers and say that MAIA might need one thing promising. Equally, if MAIA sees some partial responses and full responses, I feel that would excite the market.

Monetary overview

MAIA had ~$7.6M in money on the finish of Q1’23. R&D bills have been $2.2M for Q1’23 and G&A expense was $2M in the identical quarter. Internet loss was $4.1M for Q1’23 and web money utilized in working actions was $3.4M.

In April, the corporate raised web proceeds of roughly $5.1M from the sale of two,555,500 shares of widespread inventory at $2.25 per share ($5.75M gross proceeds). MAIA’s June Company presentation (Slide 29) notes a money steadiness of $9.57M as of June 7, 2023. I might anticipate MAIA to make it to mid Q1’24 then, assuming money burn of $3.4M per quarter, except the corporate raises additional cash. Assuming a better price of money burn, as MAIA spends extra on R&D by enrolling extra sufferers and opening extra trial websites, MAIA can at the very least make it to a fall replace (Q3’23 to This autumn’23) on knowledge from the THIO-101 trial.

As of June 7, 2023, there have been 13,625,925 shares of MAIA’s widespread inventory excellent, giving MAIA a market cap of $29.3M ($2.15 per share). That being mentioned, there are one other 7.7M shares value of choices excellent, and 0.9M of shares value of warrants excellent, bringing the totally diluted depend to almost 23M shares. Additional, the choices are, on common, not that far out of the cash at present buying and selling ranges, with a weighted common train value of $2.67.

On June 8, 2023, MAIA filed a Type S-1 with the SEC containing a preliminary prospectus for an providing of two,083,333 shares of widespread inventory noting an assumed public providing value of $2.40 (MAIA closed at $2.47 on June 8). There was no replace since relating to the providing, so shareholders ought to control the SEC filings and releases from the corporate for an extra replace on whether or not or not MAIA goes forward with this providing and any funds raised.

Conclusions

I think about MAIA a purchase as I anticipate the upcoming catalyst that’s one other replace on the THIO-101 trial within the fall (Q3’23 to This autumn’23) to lead to a rally. Even when there is not sufficient to say the drug is working, I feel there will likely be sufficient promise to excite the market. I feel the corporate’s current fund elevating actions and money steadiness ought to present the corporate with the money to get to that fall replace.

Whereas the preliminary knowledge is promising and security is nice, it’s attainable subsequent outcomes pattern again in the direction of a 3-4 month survival as MAIA has recommended is typical. Additional MAIA already trades above money, regardless of barely having sufficient for a number of extra quarters of operation and having no different trials dosing sufferers at present. As such, the identify is not a powerful purchase for my part, it is not ridiculously undervalued and whereas I do assume additional knowledge could observe the present pattern and excite the market a bit, there isn’t any assure. Certainly MAIA trades with a constructive enterprise worth in a market the place many biotechs commerce beneath money, so the market has assigned some worth to 6-thio-dG it might appear (I am assuming that’s what the market likes concerning the firm, since different tasks are preclinical).

The dangers of any lengthy in MAIA are a number of fold, a number of of that are mentioned right here. Firstly, subsequent knowledge from THIO-101 may disappoint, secondly, MAIA may fail to lift further funds resulting in considerations over money and thirdly, delays in enrolment may trigger the inventory to commerce down.

Editor’s Notice: This text covers a number of microcap shares. Please pay attention to the dangers related to these shares.