IMMUTEP LIMITED IMMUTEP LIMITED
Biotechnology
30 October 2023 21:12 GMT
FLASH NOTE
Immutep Limited (IMM-AU)
Changing the game in lung cancer survival
KEY TAKEAWAY
Immutep's LAG-3-based immune activator efti has already generated impressive late- stage data in a range of major cancers; including lung, breast, head, and neck. A safe and well-tolerated upstream activator of antigen presenting cells, efti has already showed potential in combination therapies with PD-1 / L1 inhibitors such as pembrolizumab (pembro) and chemotherapy. Data presented from its NSCLC (non-small cell lung cancer) Phase 2 trials at the recent ESMO meeting confirmed efti's potential benefit across the full spectrum of late-stage NSCLC patients. Data from TACTI-002efti-pembro indicated unprecedented improvements in duration of response and overall survival; potentially removing the need for chemo for the bulk of 1st line ("1L") patients. Impressive ORR and PFS data from INSIGHT-003 indicate that a triple efti-pembro-chemo combination could extend benefits to harder to treat poorly or non-responsive patients. With positive feedback from the FDA on TACTI-004 registrational trial and Fast Track designation, we believe efti to be on course to reach market for NSCLC by 2026E and reach a peak sales of almost $6.5bn from NSCLC alone. With a Phase 2 / 3 in metastatic breast cancer ("mBC") now underway and FDA Fast Track Designation in 1L HNSCC currently in Phase 2b, we reiterate our OUTPERFORM recommendation with our SoTP valuation at a TP A$2.88 per share.
Efti at ESMO - life changing data presented: Immutep presented data updates for TACTI-002and INSIGHT-003at ESMO congress 2023. The highlight was the remarkable Phase 2 efti-pembrocombo achieving a mOS benefit of 35.5 months in 1L NSCLC patients with PD-L1TPS ≥1% (the population for which efti holds FDA Fast Track). With the mOS data for PD-L1TPS ≥50% group still not yet reached; we can expect it to come in anywhere north of 40 months. Efti-pembrocombo far exceeds all SoC treatments in 1L NSCLC which at best have a mOS of c.23 months in the TPS ≥1%.
Superior, safe, and inclusive for all PD-L1 expression levels: Patients with low and negative PD-L1expression are notoriously difficult to target with existing approved therapies, yet they make up c.70% of 1L NSCLC patients. The Phase 2 TACTI-002of efti + pembro treatment 1L NSCLC has continued to generate outstanding efficacy data across all PD-L1expression levels while maintaining the safety profile. Efti + pembro generated robust ORR, PFS and DoR across the PD-L1spectrum, with high DoR accredited to the chemo-freeregimen. With superior 3-yearOS rates at 45.6%, 31%, and 63.6% in TPS ≥1%, TPS 1-49%and TPS ≥50% respectively. Efti continues to generate robust data in these difficult to treat patient cohorts, providing a superior alternative to the SoC.
The INSIGHT-003triple threat to NSCLC: Data from the first cohort of 21 patients in the INSIGHT-003 Phase 1 trial in 1L NSCLC shows the triplet efti-pembro-chemo is well tolerated and showing promising efficacy in this difficult to treat patient group with 81% of patients in this trial having PD-L1 TPS <50%. The triple therapy has led to an ORR of 64% and mPFS of 10.9 months in the low and negative PD-L1 expressers. Which bodes well when compared to ORR of 40.8% for the same patient cohort treated with anti- PD-1 + chemo reported from a registrational trial. The triple therapy looks to extend the current pembro-chemo SoC, expanding the treatable patient population without increasing toxicities.
Efti - in the LAG-3 asset class but nothing like the others: Unlike the LAG-3assets currently in pharma pipelines which work by blocking LAG-3on T-cells,efti's unique MOA switches on antigen presenting cells which then drive the anti-cancerresponse. We have seen promising efficacy data for efti in combination with pembro alone, chemo alone, and pembro + chemo. With further rational for efti's combination with radiotherapy being explored in the EFTISARC-NEOtrial, efti is positioned to become a mainstay in cancer treatment, strengthened by its robust safety and tolerability.
OUTPERFORM
Target Price AUD2.880
Current Price AUD0.320
EQUITY RESEARCH
DR. CHRIS REDHEAD Research Analyst T +44 (0) 203 859 7725
chris.redhead@goetzpartners.com
ALEXANDRA WALSH Junior Equity Research Analyst T +44 (0) 203 859 7725
alexandra.walsh@goetzpartners.com
This is a marketing communication. For professional investors and institutional use only. The information herein is considered to be an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5).GPSL is authorised and regulated by the Financial Conduct Authority (FRN 225563). GPSL does and seeks to do business with companies / issuers covered in its research reports. As a result, investors should beaware that GPSL may have a conflict of interest that could affect the objectivity of this research report. Investors should consider this research report as only a single factor in making their investment decision. GPSL has a formal client relationship with Immutep Limited.
Please see analyst certifications, important disclosure information, and information regarding the status of analysts on pages 3-5 of this research report.
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COMPANY DESCRIPTION
Immutep is an Australian clinical-stage biotechnology company that develops immunotherapies for cancer and autoimmune diseases. Immutep is the global leader in the understanding of and in developing therapeutics that modulate Lymphocyte Activation Gene-3("LAG-3").LAG-3 was discovered in 1990 at the Institut Gustave Roussy by Dr Frédéric Triebel, Immutep's Chief Scientific Officer and Chief Medical Officer. The company has three assets in clinical and one asset in preclinical development. The lead product candidate is eftilagimod alpha ("efti"), a first-in-class antigen presenting cell ("APC") activator being investigated in combination with chemotherapy / immune therapy / radiotherapy. Immutep is dual-listed on the Australian Stock Exchange ("IMM") and on the NASDAQ Global Market ("IMMP") in the US (American Depository Receipts), and has operations in Europe, Australia, and the US. The company has licensing deals with Novartis, GSK and EOC (China only), and clinical trial collaboration and supply agreements with Merck & Co. and Merck KGaA / Pfizer, the latter for lead asset efti.
SCENARIOS
Base Case - GP Investment Case | Bluesky Scenario | Downside risk |
Immutep generates further clinical data on | N/A | Company is unable to generate further |
efti and secures an outlicensing deal over the | positive data on efti and fails to achieve | |
next 12 - 18 months. | licensing deal. | |
Peer Group Analysis |
SWOT | INDUSTRY EXPECTATIONS |
Strengths: | Global | leadership | position |
in LAG-3 | with | 4 LAG-3 | related |
product candidates; many active clinical trials with readouts expected 2023E; strong performance of efti alongside many FDA-approved therapies; established collaborations with big players (Merck (MSD), Merck KGaA / Pfizer, Novartis and GSK).
Weaknesses: Sales growth in China dependent on EOC Pharma collaboration; single asset (efti) accounts for most of value and does not have strong efficacy data as a monotherapy; expired composition of matter patent means efti is only protected by use and formulation patents.
Opportunities: Provide a novel class of immunotherapy for use alongside many existing approved therapies across many cancer and auto-immune indications; M&A activity in the immune-oncology space.
Threats: Market entry by competitors and alternative therapies may erode sales; EMA and FDA approval for immune-oncology drugs subject to stringent criteria.
Immutep is developing immunotherapies for cancer, with a focus on the immune checkpoint LAG-3. The immune checkpoint inhibitor ("ICI") class has experienced rapid adoption since the launch of BMS's Yervoy (ipilimumab) in 2011, owing to their ability to elicit durable responses in 20
- 50% of patients for up to 10 years. The global ICI market was worth $37bn in 2022 and is expected to be worth nearly $150bn by 2030, driven largely by expanding use of existing therapies both in approved and new indications. The race is on to develop novel compounds with complementary mechanisms of action for combination therapy able to augment response rate without increasing toxicity, which, if successful, are expected to enjoy rapid uptake.
This is a marketing communication. For professional investors and institutional use only. The information herein is considered to be an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5).GPSL is authorised and regulated by the Financial Conduct Authority (FRN 225563). GPSL does and seeks to do business with companies / issuers covered in its research reports. As a result, investors should beaware that GPSL may have a conflict of interest that could affect the objectivity of this research report. Investors should consider this research report as only a single factor in making their investment decision. GPSL has a formal client relationship with Immutep Limited.
Please see analyst certifications, important disclosure information, and information regarding the status of analysts on pages 3-5 of this research report.
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Important Disclosures: Non-Independent Research
Analyst Certification
I, Dr. Chris Redhead, hereby certify that the views regarding the companies and their securities expressed in this research report are accurate and are truly held. I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this research report.
I, Alexandra Walsh, hereby certify that the views regarding the companies and their securities expressed in this research report are accurate and are truly held. I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this research report.
Meaning of goetzpartners Research Ratings
goetzpartners securities Limited ("GPSL") publishes investment recommendations, which reflect the analyst's assessment of a stock's potential relative return. Our research offers 4 recommendations or 'ratings':
OUTPERFORM - Describes stocks that we expect to provide a relative return (price appreciation plus yield) of 15% or more within a 12- month period.
NEUTRAL - Describes stocks that we expect to provide a relative return (price appreciation plus yield) of plus 15% or minus 10% within a 12-month period.
UNDERPERFORM - Describes stocks that we expect to provide a relative negative return (price appreciation plus yield) of 10% or more within a 12-month period.
NON-RATED - Describes stocks on which we provide general discussion and analysis of both up and downside risks but on which we do not give an investment recommendation.
Companies Mentioned in this report
- (BIOTECHNOLOGY)
- Immutep Limited (IMM-AU)
Valuation Methodology
GPSL's methodology for assigning recommendations may include the following: market capitalisation, maturity, growth / value, volatility and expected total return over the next 12 months. The target prices are based on several methodologies, which may include, but are not restricted to, analyses of market risk, growth rate, revenue stream, discounted cash flow (DCF), EBITDA, EPS, cash flow (CF), free cash flow (FCF), EV/EBITDA, P/E, PE/growth, P/CF, P/FCF, premium (discount)/average group EV/EBITDA, premium (discount)/average group P/E, sum of the parts, net asset value, dividend returns, and return on equity (ROE) over the next 12 months.
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This research will be reviewed at a frequency of 3 months. Any major changes to the planned frequency of coverage will be highlighted in future research reports.
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GPSL is required to disclose any conflicts of interest which may impair the firm's objectivity with respect to any research recommendations contained herein. Please click on the link to view the latest version of our Conflicts of Interest policy.
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GPSL shareholdings in relevant issuers >5% - None.
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To comply with the regulatory requirement to disclose. We disclose the monthly proportion of recommendations that are OUTPERFORM, NEUTRAL, UNDERPERFORM and NON-RATED. We also disclose a summary of the history of our analysts' investment recommendations (in accordance with EU MAR rules effective 3rd July 2016). goetzpartners publishes this information on the following link: Research Summary.
This is a marketing communication. For professional investors and institutional use only. The information herein is considered to be an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5).GPSL is authorised and regulated by the Financial Conduct Authority (FRN 225563). GPSL does and seeks to do business with companies / issuers covered in its research reports. As a result, investors should beaware that GPSL may have a conflict of interest that could affect the objectivity of this research report. Investors should consider this research report as only a single factor in making their investment decision. GPSL has a formal client relationship with Immutep Limited.
Please see analyst certifications, important disclosure information, and information regarding the status of analysts on pages 3-5 of this research report.
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Country-Specific Disclosures
United Kingdom: goetzpartners securities Limited ("GPSL") is authorised and regulated by the Financial Conduct Authority ("FCA");
registered in England and Wales No. 04684144; Registered Office / Address: The Stanley Building, 7 Pancras Square, London, N1C 4AG,
England, UK; telephone +44 (0)20 3859 7725. GPSL's FCA Firm Reference Number is: 225563. In the United Kingdom and European Economic Area, this research report has been prepared, issued and / or approved for distribution by GPSL and is intended for use only by persons who have, or have been assessed as having, suitable professional experience and expertise, or by persons to whom it can be otherwise lawfully distributed. It is not intended to be distributed or passed on, directly or indirectly, to any other class of persons. This marketing communication is classed as 'non-independent research' and, as such, has not been prepared in accordance with legal requirements designed to promote the independence of investment research. GPSL has adopted a Conflicts of Interest management policy in connection with the preparation and publication of research, the details of which are available upon request in writing to the Compliance Officer or on the web link above in the Conflicts of Interest section above. GPSL may allow its analysts to undertake private consultancy work. GPSL's conflicts management policy sets out the arrangements that the firm employs to manage any potential conflicts of interest that may arise as a result of such consultancy work.
Other EU Investors: This research report has been prepared and distributed by GPSL. This research report is a marketing communication for the purposes of Directive 2004/39/EC (MiFID). It has not been prepared in accordance with legal requirements designed to promote the independence of investment research, and it is not subject to any prohibition on dealing ahead of the dissemination of investment research. GPSL is authorised and regulated in the United Kingdom by the FCA in connection with its distribution and for the conduct of its investment business in the European Economic Area. This research report is intended for use only by persons who qualify as professional investors or eligible counterparties (institutional investors) in the applicable jurisdiction, and not by any private individuals or other persons who qualify as retail clients. Persons who are unsure of which investor category applies to them should seek professional advice before placing reliance upon or acting upon any of the recommendations contained herein.
U.S. PERSONS: This research report has been prepared by GPSL, which is authorised to engage in securities activities in England and Wales and to conduct designated investment business in the European Economic Area. GPSL is not a registered broker-dealer in the United States of America and therefore is not subject to U.S. rules regarding the preparation of research reports and the independence of research analysts. This research report is provided for distribution in the United States solely to "major U.S. institutional investors" as defined in Rule 15a-6 under the Securities Exchange Act of 1934.
Other countries: Laws and regulations of other countries may also restrict the distribution of this research report. Persons in possession of research publications should inform themselves about possible legal restrictions and observe them accordingly.
Immutep Limited Rating History as of 24/10/2023
(BUY):AUD0.90 (BUY):AUD1.24 (BUY):AUD1.35
14/12/2020 07/06/2021 06/07/2021
powered by: BlueMatrix
(BUY):AUD2.00 (BUY):AUD2.88
29/06/2022 04/04/2023
3.00
2.50
2.00
1.50
1.00
0.50
0.00
Jan 21 | Apr 21 | Jul 21 | Oct 21 | Jan 22 | Apr 22 | Jul 22 | Oct 22 | Jan 23 | Apr 23 | Jul 23 | Oct 23 | ||
Closing Price | Target Price | ||||||||||||
Risks
This is a marketing communication as defined by the Financial Conduct Authority ("FCA"). The information herein is considered an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5). Information relating to any company or security is for information purposes only and should not be interpreted as a solicitation to buy or sell any security or to make any investment. The information in this research report has been compiled from sources believed to be reliable, but it has not been independently verified. No representation is made as to its accuracy or completeness, no reliance should be placed on it and no liability is accepted for any loss arising from reliance on it, except to the extent required by the applicable law. All expressions of opinion are subject to change without notice. Opinions, projections, forecasts or estimates may be personal to the author and may not reflect the opinions of goetzpartners securities Limited ("GPSL"). They reflect only the current views of the author at the date of the research report and are subject to change without notice. GPSL's research reports are not intended for Retail Clients as defined by the FCA. This research report is intended for professional clients only. Research reports are for information purposes only and shall not be construed as an offer or solicitation for the subscription or purchase or sale of any securities, or as an invitation, inducement or intermediation for the sale, subscription or purchase of any securities, or for engaging in any other transaction. The analysis, opinions, projections, forecasts and estimates expressed in research reports were in no way affected or influenced by the issuer. The authors of research reports benefit financially from the overall success of GPSL. The investments referred to in research reports may not be suitable for all recipients. Recipients are urged to base their investment decisions upon their own appropriate investigations. Any loss or other consequence arising from the use of the material contained in a research report shall be the sole and exclusive responsibility of the investor and GPSL accepts no liability for any such loss or consequence. In the event of any doubt regarding any investment, recipients should contact their own investment, legal and / or tax advisers to seek advice regarding the appropriateness of investing. Some of the investments mentioned in research reports may not be readily liquid investments
This is a marketing communication. For professional investors and institutional use only. The information herein is considered to be an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5).GPSL is authorised and regulated by the Financial Conduct Authority (FRN 225563). GPSL does and seeks to do business with companies / issuers covered in its research reports. As a result, investors should beaware that GPSL may have a conflict of interest that could affect the objectivity of this research report. Investors should consider this research report as only a single factor in making their investment decision. GPSL has a formal client relationship with Immutep Limited.
Please see analyst certifications, important disclosure information, and information regarding the status of analysts on pages 3-5 of this research report.
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which may be difficult to sell or realise. Past performance and forecasts are not a reliable indicator of future results or performance. The value of investments and the income derived from them may fall as well as rise and investors may not get back the amount invested. Some investments discussed in research publications may have a high level of volatility. High volatility investments may experience sudden and large falls in their value which may cause losses. Some of the information or data in this research report may rely on figures denominated in a currency other than that of GBP (the currency should be stated), the return may increase or decrease as a result of currency fluctuations. International investment includes risks related to political and economic uncertainties of foreign countries, as well as currency risk. To the extent permitted by applicable law, no liability whatsoever is accepted for any direct or consequential loss, damages, costs or prejudices whatsoever arising from the use of research reports or their contents.
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Compensation
GPSL has received compensation from Immutep Limited for the provision of equity research and / or advisory services within the previous twelve months.
IMM-AU
AUD2.880 | Company Update
30 October 2023
goetzpartners securities Limited
The Stanley Building, 7 Pancras Square, London, N1C 4AG, England, UK.
Tel: +44 (0)203 859 7725
www.goetzpartnerssecurities.com
This is a marketing communication. For professional investors and institutional use only. The information herein is considered to be an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5).GPSL is authorised and regulated by the Financial Conduct Authority (FRN 225563). GPSL does and seeks to do business with companies / issuers covered in its research reports. As a result, investors should beaware that GPSL may have a conflict of interest that could affect the objectivity of this research report. Investors should consider this research report as only a single factor in making their investment decision. GPSL has a formal client relationship with Immutep Limited.
Please see analyst certifications, important disclosure information, and information regarding the status of analysts on pages 3-5 of this research report.
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Immutep Ltd. published this content on 30 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 31 October 2023 03:00:48 UTC.
