OSE Immunotherapeutics — Maintaining momentum after an active H123

OSE Immunotherapeutics (PAR: OSE)

Last close As at 22/02/2024

EUR3.34

−0.01 (−0.30%)

Market capitalisation

EUR73m

More on this equity

Research: Healthcare

OSE Immunotherapeutics — Maintaining momentum after an active H123

OSE Immunotherapeutics (OSE) has announced its H123 results, providing an operational and a financial update. Highlights from the period included positive recommendations for a confirmatory pivotal Phase III trial for lead asset Tedopi in non-small cell lung cancer (NSCLC), which is on track to commence in 2024. OSE also claimed full rights to its most advanced immuno-inflammation asset, Lusvertikimab (previously being developed in partnership with Servier). Post period, the company reported a positive safety review for Lusvertikimab from the ongoing Phase II trial in ulcerative colitis (UC). Patient enrolment is expected to be completed in Q423, with top-line results in the next few months. OSE also recently announced a €200,000 grant from the French government and Region Pays de la Loire to weave RNA therapeutics into its preclinical R&D engine, representing a new opportunity for the company. At end-June 2023, OSE had a pro-forma gross cash position of €33.6m, which we estimate will provide a runway through to Q424 (H123 cash burn of €11.7m). We value OSE at €311.3m or €14.4 per share, with Tedopi as the primary contributor to this valuation.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

OSE-Immunotherapeutics_resized

Healthcare

OSE Immunotherapeutics

Maintaining momentum after an active H123

H123 update

Pharma and biotech

3 October 2023

Price

€4.71

Market cap

€102m

€0.94/US$

Pro-forma net debt (€m) at 30 June 2023 (including September equity raise)

8.2

Shares in issue

21.6m

Free float

65%

Code

OSE

Primary exchange

Euronext Paris

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

55.6

26.6

(17.0)

Rel (local)

60.4

29.9

(31.9)

52-week high/low

€7.49

€2.70

Business description

OSE Immunotherapeutics is based in Nantes and Paris in France and is listed on the Euronext Paris exchange. It is developing immunotherapies for the treatment of solid tumours and autoimmune diseases and has established several partnerships with large pharma companies.

Next events

Lusvertikimab UC Phase II readout

Late-2023 or early-2024

Tedopi Phase III trial commencement

H124

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

Jitisha Malhotra

+44 (0)20 3077 5700

OSE Immunotherapeutics is a research client of Edison Investment Research Limited

OSE Immunotherapeutics (OSE) has announced its H123 results, providing an operational and a financial update. Highlights from the period included positive recommendations for a confirmatory pivotal Phase III trial for lead asset Tedopi in non-small cell lung cancer (NSCLC), which is on track to commence in 2024. OSE also claimed full rights to its most advanced immuno-inflammation asset, Lusvertikimab (previously being developed in partnership with Servier). Post period, the company reported a positive safety review for Lusvertikimab from the ongoing Phase II trial in ulcerative colitis (UC). Patient enrolment is expected to be completed in Q423, with top-line results in the next few months. OSE also recently announced a €200,000 grant from the French government and Region Pays de la Loire to weave RNA therapeutics into its preclinical R&D engine, representing a new opportunity for the company. At end-June 2023, OSE had a pro-forma gross cash position of €33.6m, which we estimate will provide a runway through to Q424 (H123 cash burn of €11.7m). We value OSE at €311.3m or €14.4 per share, with Tedopi as the primary contributor to this valuation.

Year
end

Revenue
(€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/21

26.3

(17.2)

(0.95)

0.0

N/A

N/A

12/22

18.3

(18.0)

(0.97)

0.0

N/A

N/A

12/23e

2.7

(26.2)

(1.34)

0.0

N/A

N/A

12/24e

15.0

(21.8)

(0.98)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

Tedopi in NSCLC remains a strategic priority

OSE’s current priority is the upcoming confirmatory pivotal Phase III trial for Tedopi in patients with advanced or metastatic NSCLC. Management aims to build on the positive results of the ATALANTE-1 trial with a larger patient population (expected n=400 participants, versus 219 in ATALANTE-1) and focus on Tedopi as a monotherapy in the second-line setting (versus second- or third-line in ATALANTE-1). While first-line treatment typically involves chemotherapy with an immune checkpoint inhibitor (ICI), resistance is a significant unmet medical need, and we believe the strategy of positioning Tedopi in the second-line setting could avoid direct competition with ICIs. This represents a sizeable opportunity for OSE to garner a share of the growing NSCLC market, which is projected to reach $56bn by 2028 (EvaluatePharma). The trial is due to commence in 2024, and we anticipate that it will conclude in 2026. We note that the study will be supported by a new diagnostic test to identify the appropriate patient population.

Valuation: €311.3m or €14.4 per share

We value OSE at €311.3m (€280.8m previously), including a pro-forma net debt position of €8.2m at end-Q223. The increase in overall valuation is driven by a reduction in net debt (€14.7m previously) combined with the positive impact of the model roll forward and FX update. However, our per-share valuation decreases to €14.4 from €15.2 previously due to a higher share count post the c €11.1m equity raise in September 2023.

An active and diverse clinical pipeline

OSE is a French biotechnology company with an active clinical pipeline comprising programmes focused on both immuno-oncology and immuno-inflammation disease areas (Exhibit 1):

Tedopi comprises a unique combination of neoepitopes, and is the most advanced neoepitopes vaccine in the clinic, to our knowledge. OSE is developing Tedopi as an off-the-shelf treatment for NSCLC patients with secondary resistance to ICIs (patients experiencing disease progression after 12 weeks of ICI treatment). Tedopi works by directly activating tumour-specific T-cells, which, in turn, bind tumour-associated antigens presented on the surface of cancer cells by the HLA-A2 receptor (c 45% of NSCLC patients are HLA-A2 positive). We note that in July 2023, OSE announced a new US patent, providing protection until at least 2037 in this region. Beyond NSCLC, Tedopi is being explored in a Phase II combination trial (sponsored by the oncology group GERCOR) for pancreatic cancer (n=136); patient enrolment was completed in May 2023 and clinical readouts are expected in Q324.

Lusvertikimab is OSE’s most advanced immuno-inflammation asset. The candidate is a monoclonal antibody designed as an antagonist of the interleukin-7 receptor (IL-7R), a cytokine on the surface of certain immune system T-cells, for the downregulation of inflammatory immune responses. Lusvertikimab is currently in a Phase II clinical trial for patients with UC; complete patient enrolment is expected in Q423, with top-line results in the next months.

OSE-279 is also in OSE’s immuno-oncology portfolio. It is an anti-PD1 monoclonal antibody ICI therapy designed for blockade of both PD-L1 and PD-L2. OSE-279 is being assessed in an ongoing Phase I/II dose-escalation trial as a monotherapy for the treatment of solid tumours or lymphomas. The aim of the study is to identify the maximum tolerated and/or recommended Phase II dose of OSE-279. The first patient was dosed in December 2022, and an update is expected in October 2023. We note that OSE-279 is the backbone therapy of the company’s bifunctional checkpoint inhibitor (BiCKI) platform, intended to address primary (no response to treatment) and secondary resistance (resistance after an initial period of response) mechanisms. It is our opinion that readouts from the OSE-279 monotherapy trial may serve to validate the company’s approach with the BiCKI platform, provided the data are positive.

FR-104/VEL-101 is in clinical development in partnership with Veloxis as a potential maintenance therapy after kidney transplantation. FR-104/VEL-101 is an anti-CD28 monoclonal antibody fragment that delivers stimulatory signals from antigen-presenting cells to the T-cells. This has application in multiple autoimmune diseases, as well as with kidney transplants. Veloxis is preparing for a Phase II trial to evaluate FR104/VEL-101 in patients undergoing kidney transplantation. Separately, in July 2023, OSE announced that patient enrolment had been completed for the University Hospital of Nantes-sponsored FIRsT study, a Phase I/II trial assessing the safety, tolerability and pharmacokinetics, as well as potential efficacy, of FR-104/VEL-101 in acute rejection prophylaxis and renal function. Management plans to report an update on this study at one-year post-treatment.

OSE-172/BI 765063 is being developed in partnership with Boehringer Ingelheim (BI). The drug is a SIRPα antagonist antibody, operating by a similar mechanism to T-cell ICIs in the tumour microenvironment, but rather than inhibiting T-cells, it is designed to inhibit the checkpoints between tumour cells and myeloid cells. OSE-172/BI 765063 is currently being evaluated in multiple Phase I clinical trials by BI for the treatment of advanced solid tumours; microsatellite stable (MSS) endometrial cancer; MSS colorectal cancer (CRC); head and neck squamous cell carcinoma (HNHCC) and hepatocellular carcinoma (HCC). Management expects to provide updates for these ongoing studies across H223, and will start preparing for Phase II trials in 2024. Further details can be found in our re-initiation note.

Exhibit 1: OSE Immunotherapeutics’ clinical development pipeline

Source: OSE Immunotherapeutics corporate presentation (July 2023)

Tedopi confirmatory pivotal Phase III trial in focus

OSE’s lead cancer vaccine recently made headlines as the results from its already completed Phase III trial (ATALANTE-1) were published in Annals of Oncology (September 2023), a high-impact medical journal. This was particularly notable as the announcement saw the company’s share price rise by c 70% from 11–12 September 2023, highlighting a significant level of interest, in our view. ATALANTE-1 was a randomised study to evaluate Tedopi as a second- or third-line treatment following ICI failure in patients with locally advanced (stage IIIb) or metastatic (stage IV) NSCLC who are HLA-A2 positive. We note that the COVID-19 pandemic had an impact on recruitment for this clinical trial, meaning that only 219 out of the planned 363 patients were enrolled. These 219 patients were randomised to receive either Tedopi (n=139) or standard-of-care (SoC) chemotherapy (docetaxel or pemetrexed, n=80). Of these, 118 (54%) met the definition of population of interest (secondary resistance, ie progression after 12 weeks of ICI treatment) and were used for the main analysis. The results (first presented in September 2021) showed that Tedopi met its primary endpoint with significantly improved overall survival (OS) rates, while also maintaining positive patient-reported outcomes, quality of life and safety. Highlights from the trial included:

Risk of death reduced by 41% in the Tedopi arm.

Median OS was 11.1 months with Tedopi versus 7.5 months with SoC.

OS rate at 12 months was 44.4% with Tedopi versus 27.5% with SoC.

Median post-progression survival was 7.7 months with Tedopi versus 4.6 months with SoC.

Rate of severe adverse events was just 11% with Tedopi versus 35% with SoC.

While the data were encouraging for both the efficacy and safety of Tedopi in this patient population, discussions with regulators concluded that it was not sufficient for regulatory approval. This decision was attributed to the early termination of patient enrolment due to the COVID-19 pandemic, which meant that the pre-planned analysis according to the original trial design was not feasible. However, in February 2023, OSE received positive recommendations to conduct a follow-on confirmatory pivotal Phase III trial. Both the FDA and EMA provided scientific advice for this study, which we believe will build on the results of ATALANTE-1 by acquiring more data in a larger NSCLC patient population, and focus on Tedopi as a potential second-line monotherapy, rather than a second- or third-line treatment. Management has communicated that it will aim to recruit c 400 patients, and that the trial is on-track to commence in 2024, and we expect it will conclude in 2026. The results from this confirmatory pivotal trial could be a significant catalyst for the company, and provided the data continue to be supportive, we anticipate a launch for this product in 2028.

Lusvertikimab (OSE-127) readouts in UC incoming

Lusvertikimab is an IL-7R antagonist targeting CD127, a cytokine that modulates the proliferation, apoptosis and activation of CD4 and CD8 T-cells. To our knowledge, this is a novel and differentiated mechanism of action for immuno-inflammation therapies. Initially, Lusvertikimab was developed as a part of an option licence agreement with Servier. Two Phase II studies were launched, one of which was assessing the antibody for the treatment of primary Sjögren’s syndrome (SS), sponsored by Servier, and the other for the treatment of UC, fully funded by OSE. Servier had the option to assume full development in both indications after completion of the Phase II clinical trials. However, following negative results from the SS trial, attributed to uncertainty in the role of IL-7 biology in the disease, OSE and Servier mutually decided to terminate the option licence agreement. Despite this, OSE remain committed to the clinical development of Lusvertikimab in UC with full rights to the asset. This represents a potentially sizeable opportunity for OSE, in our view, as the UC market is projected to reach $11bn by 2028 (EvaluatePharma).

The Phase II multicentre, randomised, double-blind, placebo-controlled trial investigating Lusvertikimab in patients with moderate to severe UC is ongoing (Exhibit 2). In July 2023, OSE announced a positive review from the independent drug safety monitoring board (DSMB). It was recommended by the DSMB that the trial should proceed without any modifications to the design, which we view as a positive indicator that the trial is progressing as planned and without indications that the safety profile of the drug in treated patients to date is provoking cause for concern. The trial is expected to be fully enrolled (n=150) in Q423, slightly later than prior guidance of Q323. The top-line results after induction (primary endpoint at week 10) are expected in late-2023 or early-2024. With Lusvertikimab being OSE’s most advanced asset in the immuno-inflammation space, we believe readouts from this Phase II trial may represent a significant catalyst for investor attention.

In July 2023, OSE also announced that the EMA had provided a positive opinion on Orphan Drug designation for Lusvertikimab in acute lymphoblastic leukaemia (ALL). This was based on preclinical results from a collaborative research programme with the University Medical Center Schleswig-Holstein in Kiel (Germany). The research demonstrated the therapeutic potential of Lusvertikimab in targeting and blocking the high and dysregulated expression of IL-7R, which, according to management, is observed in 84% of B- or T-cell ALL patients. Notably, the antibody was found to have significant activity in models involving leukemic samples from refractory and relapsed ALL patients. While we note that these data were first reported in December 2022, we believe that the positive opinion from the EMA is encouraging for a potential clinical programme for Lusvertikimab in ALL. OSE may explore this indication with a Phase I/II trial in 2024; we await further details from management.

Exhibit 2: Phase II trial design for Lusvertikimab in UC

Source: OSE Immunotherapeutics corporate presentation (July 2023)

Financials

OSE reported a 23.4% year-on-year decline in its operating expenses for H123 to €14.9m. This was primarily driven by a 32.7% reduction in R&D expenses, which dropped from €14.4m in H122 to €9.7m in H123, led by management’s efforts to reduce operational and social expenses and the receipt of a €2.9m subsidy from PSPC CoVepiT (which was netted into the company’s reporting of R&D expenses; gross R&D costs excluding this and all other subsidies were €15.8m, down 11.4% y-o-y). However, these lower operating expenses were offset by a material reduction in revenue related to licensing agreements (€1.4m in H123 vs €16.0m in H122) resulting in an operating loss for H123 of €13.5m (H122: €3.4m). Net loss was also up from €2.0m in H122 to €11.9m in H123. We note that the revenue in H123 only consisted of re-invoicing of some development costs, as compared to H122 which also included ~€14m in development milestone payments related to its licensing agreements.

Net cash outflow from operating activities was €11.7m in H123, a significant increase from €1.9m in H122. The figure was negatively affected by a reduction in the operating income of the company, as discussed above.

With the company making efforts to reduce its operating costs and the expected conclusion of the OSE-sponsored Phase II study in UC of OSE-127/S95011 in FY23, we continue to expect operating expenses for OSE to decrease ~20% y-o-y in FY23. However, we estimate costs will increase in FY24 as the Phase III Tedopi study is initiated. Further, based on the H1 revenue figure, we have lowered our revenue estimate for FY23. For FY24, we continue to expect €15.0m revenue driven by milestone payments expected to be received with respect to its licensing agreements (including the BI agreement). As a result, we now estimate higher operating cash outflows of €20.4m in FY23 (from €16.1m previously) while keeping our FY24 forecast broadly unchanged at €20.1m.

As of 30 June 2023, OSE had a gross cash position of €15.0m and a net debt position of €24.7m (FY22 net debt: €14.7m). We note that this will be supplemented by (a) the 2022 R&D tax credit of €5.4m received in July 2023, (b) the balance loan of €2.1m from the banking pool received in July 2023 (OSE drew down €3.1m out of the total €5.3m loan before 30 June 2023) and (c) the €11.1m equity financing from Vester through the issuance of 2.61m shares (excludes c €0.5m equity financing from Vester raised in May 2023 through the issuance of 0.13m shares). Therefore, on a pro-forma basis, OSE’s gross cash position and net debt position stand at €33.6m and €8.2m, respectively. We have incorporated these financings in our model, resulting in changes to our debt and cash forecasts for the next two years. At our projected cash burn rate for H223 and FY24, we forecast OSE to be operationally funded into Q424, which is in line with management guidance.

As a reminder, in our model, we assume OSE secures an out-licensing deal for Tedopi by end-2027. We assume the company receives licensing/development milestones associated with Tedopi and other assets, including those from existing deals with Veloxis and BI, before reaching steady, revenue-generating operating profitability following the commercial launch of Tedopi in FY28. Taking into account these expected milestone payments and the recent financing by the company, we estimate OSE would be required to raise a total of c €30m additional funds to reach this point. We account for this raise as illustrative debt in our model. Alternatively, if the funding is realised through an equity issue instead (assuming at the current trading price of €4.71/share), OSE would have to issue ~6.4m shares, resulting in our per-share valuation coming down to €11.1 from €14.4 currently (shares outstanding would increase from 21.6m to 28.0m).

Valuation

We value OSE at €311.3m or €14.4 per share (€280.8m or €15.2 per share previously) on a risk-adjusted NPV analysis using a 12.5% discount rate, including pro-forma net debt of €8.2m at 30 June 2023 (gross cash of €15.0m, net of €5.4m in short-term debt and €34.3m in long-term debt and pro forma adjusted for €11.1m equity raise in September 2023 and €5.4m tax credits received in July 2023).

We continue to value five assets in our valuation of OSE: Tedopi in NSCLC, OSE-127 in UC, OSE-172/BI 765063, FR-104/VEL-101 and OSE-279. Further, we keep our key rNPV assumptions related to target market, product pricing, trial timelines, licensing deals and probability of success unchanged from previously (as discussed in detail in our initiation note in May).

Exhibit 3: Sum-of-the-parts OSE valuation

Product

Launch

Peak sales (€m)

NPV
(€m)

NPV/share (€)

Probability

rNPV
(€m)

rNPV/share (€)

Tedopi – NSCLC

2028

572

390.2

18.0

48%

179.5

8.3

OSE-127 – ulcerative colitis

2028

847

297.4

13.7

17%

53.3

2.5

BI 765063 – multiple cancer indications (MSS CRC)

2028

545

191.6

8.9

14%

31.2

1.4

FR104 – Veloxis deal milestones (kidney transplantation)

2028

98

140.0

6.5

17%

27.8

1.3

OSE-279 solid tumours (SCLC)

2029

380

160.6

7.4

14%

27.6

1.3

Pro-forma net cash/(debt) at 30 June 2023

(8.2)

(0.4)

100%

(8.2)

(0.4)

Valuation

 

 

1,171.6

54.1

 

311.3

14.4

Source: Edison Investment Research

Exhibit 4: Financial summary

€000s

2020

2021

2022

2023e

2024e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

10,432

26,306

18,302

2,716

15,000

Cost of Sales

0

0

0

0

0

Gross Profit

10,432

26,306

18,302

2,716

15,000

Research and development

(22,355)

(30,550)

(26,893)

(22,382)

(27,670)

Overhead expenses

(4,783)

(8,608)

(6,673)

(6,873)

(7,079)

EBITDA

 

(18,259)

(13,601)

(14,992)

(25,346)

(18,515)

Operating Profit (before amort. and excepts.)

 

(18,989)

(16,625)

(18,478)

(26,539)

(19,750)

Intangible Amortisation

0

0

0

0

0

Exceptionals

0

0

0

0

0

Other

0

0

0

0

0

Operating Profit

(18,989)

(16,625)

(18,478)

(26,539)

(19,750)

Net Interest

(258)

(589)

455

309

(2,036)

Profit Before Tax (norm)

 

(19,247)

(17,214)

(18,023)

(26,230)

(21,785)

Profit Before Tax (reported)

 

(19,247)

(17,214)

(18,023)

(26,230)

(21,785)

Tax

2,692

364

263

84

0

Profit After Tax (norm)

(19,247)

(17,214)

(18,023)

(26,230)

(21,785)

Profit After Tax (reported)

(16,555)

(16,850)

(17,760)

(26,146)

(21,785)

Average Number of Shares Outstanding (m)

15.6

18.2

18.5

19.6

22.1

EPS - normalised (c)

 

(123.72)

(94.82)

(97.28)

(134.05)

(98.48)

EPS - reported (€)

 

(1.06)

(0.93)

(0.96)

(1.34)

(0.98)

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

Gross Margin (%)

100.0

100.0

100.0

100.0

100.0

EBITDA Margin (%)

N/A

N/A

N/A

N/A

N/A

Operating Margin (before GW and except.) (%)

N/A

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

57,141

57,670

54,580

53,636

52,752

Intangible Assets

52,600

51,122

48,784

47,940

47,096

Tangible Assets

947

926

743

643

603

Investments

3,594

5,622

5,053

5,053

5,053

Current Assets

 

39,832

44,205

37,200

32,303

30,787

Stocks

0

0

0

0

1

Debtors

1,074

772

403

423

444

Cash

29,368

33,579

25,620

24,817

23,280

Other

9,390

9,854

11,177

7,063

7,063

Current Liabilities

 

14,128

16,762

16,268

16,695

17,143

Creditors

10,286

9,607

8,539

8,966

9,414

Short term borrowings

50

1,611

3,093

3,093

3,093

Other

3,792

5,544

4,636

4,636

4,636

Long Term Liabilities

 

21,481

37,224

42,855

51,134

67,671

Long term borrowings

16,552

30,801

37,231

46,238

63,377

Deferred tax liabilities

2,080

1,748

1,514

1,514

1,514

Other long term liabilities

2,849

4,675

4,110

3,382

2,780

Net Assets

 

61,364

47,889

32,657

18,110

(1,275)

CASH FLOW

Net income

 

(16,555)

(16,850)

(17,760)

(26,146)

(21,785)

Movements in working capital

 

(2,920)

1,025

(3,142)

4,521

427

Depreciation and other

730

3,024

3,486

1,194

1,234

Net Interest

273

634

(3,066)

0

0

Tax

(2,742)

(696)

(499)

0

0

Others

1,938

2,944

2,728

0

0

Net Cash Flows from Operations

 

(19,276)

(9,919)

(18,253)

(20,431)

(20,124)

Capex

(210)

(472)

(274)

(250)

(350)

Acquisitions/disposals

0

0

0

0

0

Others

(294)

(355)

300

0

0

Net Cash Flow from Investing Activities

 

(504)

(827)

26

(250)

(350)

Equity Financing

17,427

265

6

11,600

2,400

Debt financing

6,635

15,241

11,046

9,007

17,139

Other

(755)

(549)

(785)

(728)

(602)

Dividends

0

0

0

0

0

Net Cash Flow from Financing Activities

 

23,307

14,957

10,267

19,879

18,937

Effect of FX

0

0

0

0

0

Net Cash Flow

 

3,527

4,211

(7,960)

(802)

(1,537)

Opening net debt/(cash)

 

(16,083)

(12,766)

(1,167)

14,704

24,514

Change in debt

6,843

15,810

7,912

9,007

17,139

Change in cash

(3,527)

(4,211)

7,960

802

1,537

Closing net debt/(cash)*

 

(12,766)

(1,167)

14,704

24,514

43,190

Source: Company accounts, Edison Investment Research. Note: *Excluding lease liabilities.

General disclaimer and copyright

This report has been commissioned by OSE Immunotherapeutics and prepared and issued by Edison, in consideration of a fee payable by OSE Immunotherapeutics. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

General disclaimer and copyright

This report has been commissioned by OSE Immunotherapeutics and prepared and issued by Edison, in consideration of a fee payable by OSE Immunotherapeutics. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

More on OSE Immunotherapeutics

View All

Latest from the Healthcare sector

View All Healthcare content

Research: Healthcare

Basilea Pharmaceutica — FDA accepts New Drug Application for ceftobiprole

Basilea has announced that the US FDA has accepted its New Drug Application (NDA) for ceftobiprole. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of 3 April 2024, meaning that Basilea will have a regulatory decision for its lead antibiotic asset in the US in early-Q224, consistent with prior guidance. Supported by three separate Phase III clinical trials, the company is seeking approval for three indications: Staphylococcus aureus bacteraemia (SAB), acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). With the bacterial infection market in the US representing a sizeable opportunity, we believe the decision from the FDA could represent a significant catalyst for Basilea.

Continue Reading

Subscribe to Edison

Get access to the very latest content matched to your personal investment style.

Sign up for free