Herantis Pharma - Halting Neurodegenerative Diseases

Here are Antti’s comments regarding the recent news. :slight_smile:

Herantis announced on Tuesday that it has entered into a collaboration agreement with the Swiss company Indiv to utilize digital biomarker technology in the upcoming Phase II study of the HER-096 drug candidate. The news is a step forward in study design that aligns with expectations, as we have previously estimated that the company plans to use digital methods for monitoring patient symptoms. The technology can improve the study’s sensitivity to detect potential treatment effects within a relatively short follow-up period.

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Herantis CEO Antti Vuolanto spoke about the company as an investment opportunity at the Investor Day :slight_smile:

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June 2nd: Phase 2 preparation status update to be held

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The company has already reported on both topics, although they could certainly provide endless additional details. Since the finance team is also present, I wonder how it relates to those topics. A press release regarding financing negotiations? It would be strange at this point and perhaps a bad sign for that side of things…

The information provided regarding the Phase 2 study has been quite general so far. In the interview linked by Sijoittaja-alokas above, Vuolanto mentions that they aim to provide more detailed information about the P2 study design “within the next four weeks,” which likely means going deeper into concrete scientific, clinical, and practical details. One could certainly hope for news regarding the financing arrangements as well, but in my opinion, that is fairly unlikely.

Edit: And naturally, there will likely be more detailed information about the Invidi collaboration, and the audience will have the opportunity to ask questions.

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Positive FDA news was released a moment ago

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Herantis Pharma’s Chief Scientific Officer Henri Huttunen was interviewed by Antti :slight_smile:

Topics:

(00:00) Introduction
(00:09) Phase 2 study
(00:55) Endpoint
(02:05) Digital tools
(03:10) Secondary endpoints
(03:50) 100-patient study
(06:23) Study timeline
(07:29) Pros and cons of the study
(09:18) Role of the FDA
(11:04) Post-study period
(12:25) Phase 3 / Phase 2b
(13:29) Financing situation

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Antti has updated the new company report based on the latest information :slight_smile:

Herantis Pharma released additional details regarding the next clinical trial for the HER-096 drug candidate for Parkinson’s disease. The Phase 2a trial, aiming for preliminary proof of efficacy, is likely to begin next year and last approximately two years. The completion of results will take longer than our previous forecast, so we are shifting our estimate for the drug’s launch to 2034 (previously 2033). The postponement of cash flows lowers the share value in the DCF calculation, so we are adjusting our target price to 2.2 euros (prev. 2.4 €). Our assessment of the risk-reward ratio remains unsatisfactory, so we are lowering our recommendation to Reduce (prev. Accumulate).

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Could you provide a brief summary instead of just a link?

I’m personally banned from X, so it’s difficult to read.

And just in general, too.

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Here are Antti’s comments regarding the new Chief Medical Officer. :slight_smile:

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A fairly essential piece of news is still missing, namely how the financing will be handled. This is starting to look a bit like the actions of a certain Turku-based drug development company. They build a foundation and faith in the future, and then the stated main goal—partnering—suddenly changes to more independent operations. It will be interesting to see how things progress in the case of this company.

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I understand the viewpoint, but in my opinion, Herantis has still handled things quite well.

Even though a partnership hasn’t been achieved yet (whether the reason is a lack of interested partners, failure to reach an agreement, or a desire not to involve a partner yet), Herantis has still succeeded extremely well in raising capital, including non-dilutive funding, and the cost structure is leaner than that of the Turku-based company.

They already have €8M in completely non-dilutive EU Horizon funding for the Phase 2 implementation, and €10.8M in EIC funding remains unused. The €4.2 million directed share issue in the spring was carried out at a price of €1.75, and the share price has hovered above the issue level almost constantly since then. According to the company’s own words, over 50% of the Phase 2 funding has been identified/secured. I would believe that the Parkinson’s foundations involved in financing Phase 1, the Michael J. Fox Foundation and Parkinson’s UK, are certainly interested in being involved in financing Phase 2 as well, if the company decides to carry it out without a partnership. After this, some x-million share issue would likely still be needed to have the necessary funds for the Phase 2 implementation.

Personally, I wouldn’t mind anymore if it was decided to carry this out independently, as I don’t believe it would significantly affect the share price level. Of course, from a risk management and value-unlocking perspective, I would also welcome partnership news with open arms :blush:

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It looks like Eli Lilly has acquired Ajax Therapeutics, a company whose drug candidate is entering Phase 1.

The total purchase price is $2.3 billion.

It just occurred to me: with those partnership discussions underway and reportedly over ten interested candidates involved, could this eventually turn into an acquisition as well?

Lilly to acquire Ajax Therapeutics to advance outcomes for patients with myelofibrosis and polycythemia vera | Eli Lilly and Company

https://share.google/zYzrU0gdhUdWCzOcM

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It’s no wonder Nurix was a billion-dollar company even before that announcement. You see, they are playing with multiple cards:

Nurix Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update

Google partial translation:
In addition to the collaboration with Roche, Sanofi continues to develop the STAT6 degrader, NX-3911, in IND-enabling studies. Following clinical proof of concept, Nurix has the right to participate in a 50/50 profit share and co-development in the United States. Gilead continues to develop the IRAK-4 degrader, GS-6791, in an ongoing first-in-human Phase 1 study in healthy volunteers. Following Phase 1, Nurix has the right to participate in a 50/50 profit share and co-development in the United States, subject to certain limitations. Nurix and Pfizer continue to advance multiple preclinical Degrader-Antibody Conjugate (DAC) programs. In the second quarter of 2026, Nurix received a $2 million milestone payment from Sanofi.

Finnish companies (Herantis, Faron) could learn a thing or two from that. Aiforia seems to be giving it a try.

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A new drug entering the market affects the entire field, and partnership negotiations are certainly complicated for AI [companies] or anyone else. Where does the information about the 7-9 month negotiation period come from? What if they were to enter negotiations with a sale in mind? And at the same time, accept the current market, where the big players are becoming even bigger and more powerful. A company gathering millions of € here and there in phase one… it’s a long road to revenue. Just hit the sell button, Herantis​:innocent:

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A new update has just arrived from Gain Therapeutics regarding their Phase 1b Parkinson’s disease trials: Gain Therapeutics CEO Gene Mack Issues Letter to Shareholders and Provides Operational Update - Perspectives from Gain Therapeutics.

“The results – both from our Phase 1b study of rexaceract and open-label extension – continue to support our hypothesis for the drug candidate and its mechanism of action and we continue to observe safety and tolerability through five months of treatment. We also continue to see strong engagement in the open-label extension. All 16 participants who entered the ongoing Phase 1b extension study remained on study at Day 150, and following the most recent review on July 6, 2026, an independent Data Monitoring Committee recommended the study continue without modification.”

"While longer term outcomes in this dosing extension are anticipated to read out in October 2026, we have already released encouraging data from Part 1 and Part 2 of the study which includes the first 90 days (3 months) administration of rexaceract, during which reduction in cerebrospinal fluid (CSF) levels of glucosylsphingosine (GluSph) in patients with elevated levels at baseline correlated with an early clinical benefit. That response is largely maintained after at least five months of administration, while the entire cohort of 16 patients can be categorized as non-progressors at both three and five months regardless of baseline characteristics. We look forward to the next updates at 270 days and 360 days, which will occur over the summer and at the conclusion of the study in October 2026. "

This is perhaps the best peer company for Herantis that I have found. The results are similar so far, meaning good tolerability for the drug candidate in Phase 1 trials and indications of the drug’s biological effect. Otherwise, the results are still too early to interpret efficacy.

That Gain drug candidate is a β-glucocerebrosidase activator and its mechanism likely also affects the same pathways influencing proteostasis via lysosomal function as HER-096. However, I am not entirely sure if all Parkinson’s patients would potentially benefit from that Gain treatment, or only patients who have deficiencies in that β-glucocerebrosidase function.

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