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Valuation Reports

Thiogenesis Valuation Report
“A prodrug for mito dysfunction?”
TTI-0102: three POCs to prove its blockbuster potential

Thiogenesis’ key driver, TTI-0102, is a “pipeline in a product” for diseases characterized by mitochondrial dysfunction. TTI-0102 will initially target three pediatric indications, MELAS, Rett syndrome and pediatric NASH with estimated total peak sales amounting to CAD 9.6 bn and ample patent life until at least 2037. TTI-0102, being a prodrug of cysteamine, is eligible to use the US expedited 505(b)(2) regulatory pathway and the EU hybrid MAA pathway, substantially cutting development timelines and costs. In the next 9 months, POC trials should to start in MELAS, Rett syndrome, and pediatric NASH. Substantial equity upside should be unlocked once the POC trials start and positive results are reported.

Key catalysts include:
1. Start TTI-0102 POC trial in MELAS (Q1 2024)
2. Start TTI-0102 POC trial in Rett syndrome (mid-2024)
3. Start TTI-0102 POC trial in pediatric NASH (mid-2024)
vL Thiogenesis Valuation Report 11JAN24.
Adobe Acrobat Document 1.1 MB
Newron Valuation Report
“A pivotal year”
Study 014/015 excels – "Study 008A" results in March

Results of “Study 014/015 of evenamide in treatment-resistant schizophrenia (TRS) continue to surprise with unprecedented efficacy with ~25% of patients achieving remission (cure) and >70% experiencing a clinically relevant reduction in disease severity at one-year potentially transforming TRS treatment. A phase III trial, “Study 016”, in TRS will start, which, if it replicates “Study 014/015”, would lead to swift approval of evenamide in TRS based on a single trial. Substantial equity upside should be unlocked with the start of “Study 016”, positive results of pivotal “Study 008A” in non-TRS, and a partnering deal with a major CNS player.

Key catalysts include:
1. Results “Study 008A” of evenamide in non-TRS (March 2024)
2. Partnering evenamide with a major CNS player (before starting “Study 016”
3. Start pivotal “Study 016” trial of evenamide in TRS (end Q2 2024)
vL Newron Valuation Report 8JAN24.pdf
Adobe Acrobat Document 793.9 KB
Cosmo Valuation Report
"Back to the roots"
2023 guidance reiterated - strong Winlevi H2 ahead

Cosmo reported H1 2023 results driven by strong GI Genius, Lialda, and Contract manufacturing growth. Winlevi’e royalties were up sharply, offset by a drop in manufacturing income, expected to rebound in H2 2023. Cosmo will repay the EUR 175 mn convertible bonds in November 2023 with cash at hand. FY 2023 guidance was maintained despite the USD currency headwind signaling a strong H2 boosted by strong upfront and sales milestones for Winlevi with several new commercialization agreements underway.

Key catalysts include:

1. CB-01-33 (colesevelam) start of phase II POC trial in bile acid diarrhea (H2 2023)
2. Winlevi licensing agreements (during 2023)
3. Winlevi filing for EU approval (H2 2023)
Cosmo Valuation Report 7AUG23.pdf
Adobe Acrobat Document 771.2 KB
Santhera Valuation Report
“Against all odds”
A much-needed Catalyst - substantial dilution avoided

The Catalyst licensing agreement for vamorolone rights in North America, valued at up to USD 231 mn plus royalties, significantly improves the risk/reward profile for Santhera. Based on our forecasts, the stock continues to provide significant equity upside - a multiple from the current depressed share price - but without substantial share dilution to raise cash for a US and EU specialist sales force with the risk of running out of cash in the crucial launch stage if unsuccessful. Santhera is now a much de-risked company with an experienced partner in North America with the potential to accelerate vamorolone development in new indications outside DMD and a cash runway into Q1 2025 (from Q4 2023).

Key catalysts include:
1. Vamorolone US approval in DMD - PDUFA date (26 October 2023)
2. Vamorolone EU approval in DMD (Q4 2023)
3. Vamorolone UK approval in DMD (Q4 2023)
vL Santhera Valuation Report 26JUN23.pdf
Adobe Acrobat Document 816.4 KB
Basilea Valuation Report
"Return to anti-infectives and profits"
2023 net profit to at least triple, slight US Zevtera delay

Basilea guides 2023 net profit to at least triple on already strong results in 2022. The slight delay of Zevtera’s US filing in three indications (SAB, ABSSSI, and CABP) to Q3 2023 (from March/April 2023) has a negligible effect as QIDP status provides 10-year market exclusivity from the day of launch. Zevtera should get a considerable boost on contracting a US commercialization partner and the launch in the lucrative US market. Basilea is one of the few Swiss biotechs with sustainable profits.

Key catalysts include:
1. US NDA filing of Zevtera for severe bacterial infections (Q3 2023)
2. US commercialization partner for Zevtera (before Q2 2024)
3. US approval of Zevtera for severe bacterial infections (Q2 2024)
vL Basilea Valuation Report 26APR23.pdf
Adobe Acrobat Document 1.9 MB
Relief Therapeutics Valuation Report
“Play ACE!”
Olpruva US launch early July - reverse share split

Upon shareholder approval (EGM 28 April 2023), Relief plans a reverse share split of 400 current for 1 new share, complying with the minimum share price required for a secondary listing on the US NASDAQ stock exchange. The US launch of PKU GOLIKE and the upcoming US launch of Olpruva (ACE-001) in UCDs boost near-term revenue. Successful development of Relief’s diversified pipeline, including RLF-100 in rare respiratory diseases, RLF-OD032 in PKU, and RLF-TD011 in EB, are future revenue generators. Relief has a cash runway through Q3 2023. An estimated CHF 30 mn additional funding, needed to reach breakeven guided for late 2024, should primarily be raised through non-dilutive regional product out-licensing agreements.

Key catalysts include:
1. US launch of Olpruva (ACER-001) in UCDs (early July 2023)
2. RLF-100 INHALED start of phase IIb sarcoidosis trial (Q2/Q3 2023)
3. EU filing of ACER-001 in UCDs (H2 2023)
vL Relief Therapeutics Valuation Report
Adobe Acrobat Document 1.4 MB
Spexis Valuation Report
“Catching breath in lung disease”
ColiFin US phase III CF trial to start in H1 2023

Spexis provides a unique, low clinical risk, high reward investment, yet, dependent on securing sufficient funding. Lead drug ColiFin (branded inhaled colistin), approved in the EU for cystic fibrosis (CF), needs only a single positive phase III trial to gain US approval. In the US, generic versions of inhaled colistin are prescribed “off label” by physicians at their own risk to treat CF patients, given its favorable profile. Following US approval, the roughly 36% of CF patients on generic colistin could be rapidly switched to branded ColiFin, while gaining traction in new patients and enjoying 12 years of US market exclusivity from FDA approval. We forecast CHF 300+ mn US peak sales for ColiFin.

Key catalysts include:
1. Strategic decision on balixafortide (H2 2022)
2. Start of ColiFin “COPILOT” dosing trial in CF (H1 2023)
3. Start of ColiFin single pivotal US phase III “COPA” trial
vL Spexis Valuation Report 17AUG22.pdf
Adobe Acrobat Document 1'023.4 KB
Addex Valuation Report
“Back to the future - fast forward”
USD 339 mn Indivior deal highlights pipeline potential

The USD 339 mn strategic agreement with Indivior to accelerate development of ADX71441 in addiction highlights the underlying value of Addex’ allosteric modulator pipeline and extends it cash runway into 2021. The company plans to raise sufficient funds in 2018 to finance pivotal development of dipraglurant in PD-LID and dystonia, both with blockbuster peak sales potential. Successful funding is the last step in Addex' development strategy to unlock the value of its key pipeline projects.

Key catalysts include:
1) Start phase IIa POC trial of dipraglurant ER in dystonia (H2 2018)
2) Start phase I trial of ADX71441 in addiction (H2 2018)
3) Start 1st pivotal phase III trial of dipraglurant IR in PD-LID (H2 2018)
vL Addex Valuation Report 8JAN18.pdf
Adobe Acrobat Document 1.3 MB
Kuros Valuation Report
"Fit for Growth"
KUR-023, the first product to reach the market in 2017

Kuros’ key projects target sizable market opportunities in surgical sealants with KUR-023 (dural membrane sealant); and orthobiologics with KUR-111 (bone graft substitute) and KUR-113 (bone fracture healing), with combined peak sales of more than CHF 1.5 bn. With cash of CHF 18 mn (June 30, 2016), the company has sufficient funds to launch KUR-023 in the EU in 2017, and prepare KUR-111 and KUR-113 for phase III development. Additional financing will be needed to bring KUR-111 and KUR-113 successfully to market. Legacy Cytos collaborations (not in our forecasts) provide significant upside potential without any further funding requirements.

Key catalysts include:
1. Filing CE marking dural membrane sealant KUR-023 (~end 2016)
2. Start US PMA clinical trial KUR-023 in spine patients (2017)
3. EU approval, partnering agreement, and launch of KUR-023 (2017)
vL Kuros Valuation Report 27JUN16.pdf
Adobe Acrobat Document 1.3 MB