EQUITY RESEARCH
COMPANY UPDATE
Biotechnology | Immutep Limited | Buy |
IMMP - NASDAQ | September 20, 2021 | The Case for LAG-3 is Building | |||||||||
Intraday Price 9/20/21 | $3.65 | Summary | |||||||||
Rating: | Buy | • | Could a LAG-3 be the next approved checkpoint? This morning, Bristol- | ||||||||
12-Month Target Price: | $8.00 | ||||||||||
52-Week Range: | $1.53 - $7.95 | Myers Squibb (BMY - NR) announced that the FDA had accepted Bristol's | |||||||||
Market Cap (M): | 278.1 | Biologics License Application (BLA) for LAG-3 (relatlimab) / PD-1 (nivolumab) | |||||||||
Shares O/S (M): | 76.2 | combination as treatment for patients with metastatic melanoma for Priority | |||||||||
Float: | NA | Review. PDUFA is March 19, 2022. | |||||||||
Avg. Daily Volume (000): | 341.5 | • | This follows shortly after an update on the Phase 2/3 RELATIVITY-047 study | ||||||||
Debt (M): | $6.2 | at this year's ESMO Congress (being held from Sept. 16-21), where prolonged | |||||||||
Dividend: | $0.00 | ||||||||||
benefit was reported with relatlimab/nivo combination vs. nivo monotherapy | |||||||||||
Dividend Yield: | 0.0% | ||||||||||
(see details below). | |||||||||||
Risk Profile: | Speculative | ||||||||||
• | Recall, LAG-3 as a checkpoint has generated significant interest since | ||||||||||
Fiscal Year End: | June | ||||||||||
Bristol's initial RELATIVITY data release on March 25, 2021. | |||||||||||
Total Expenses ('000) | • | What about Immutep's eftilagimod ('efti')? Immutep currently has the most | |||||||||
2021A | 2022E | 2023E | LAG-3 products (four in total) and is the only company exploring the utility | ||||||||
H1 | of LAG-3, both in immune-oncology and in autoimmune disease. The lead | ||||||||||
9,707 | 9,399 | 9,948A | |||||||||
asset, efti, has a differentiated mechanism of action, as a soluble LAG-3 fusion | |||||||||||
H2 | 7,462 | 9,799 | 10,777 | ||||||||
FY | 17,169 | 19,198 | 20,726 | protein that acts as an antigen-presenting cell (APC) activator (vs. a direct | |||||||
inhibitor). To date, efti has demonstrated activity and a good safety profile | |||||||||||
IMMP | in multiple trials (such as TACTI-002 currently underway in combination with | ||||||||||
Merck's {MRK - NR} Keytruda). | |||||||||||
6 | Price (USD) | Source: Factset | Volume (MM) 300 | ||||||||
• | Conclusion. Bristol's LAG-3 is set for regulatory review, ahead of the | ||||||||||
5 | 250 | checkpoint TIGIT, which may come as a surprise to some. While Bristol's | |||||||||
200 | relatlimab may be the first-to-market, there is room for multiple LAG-3 players | ||||||||||
4 | (just like PD-1/PD-L1s), in our view. | ||||||||||
150 | Details | ||||||||||
3 | 100 | ||||||||||
RELATIVY-047 study is a | positive readthrough for | efti. The | Phase | 2/3 | |||||||
2 | 50 | ||||||||||
RELATIVITY study (N=714) | is evaluating fixed dose | relatlimab | (anti-lag | 3) | |||||||
1 | 0 | in combination with anti-PD-1 antibody, nivolumab (nivo), in 1L metastatic or | |||||||||
Nov-20Jan-21Mar-21 | May-21 | Jul-21 | Sep-21 | unresectable melanoma patients. The trial design is also stratified by both PD-L1 | |||||||
Price | Volume | and LAG-3 expression. Data from the RELATIVITY study reported at the 2021 ASCO | |||||||||
Annual Meeting reported significant PFS (progression-free benefit) benefit seen with | |||||||||||
Immutep is listed on the ASX (IMM) and with ADR's traded | the combination of relatlimab + nivo (n=355) over nivo monotherapy (n=359): 10.12 | ||||||||||
months vs. 4.63 months. (HR=0.75). There were also no significant safety signals | |||||||||||
on NASDAQ (IMMP). 1 ADR= 10 shares of common stock. | |||||||||||
(SAEs Grade 3/4 of 18.9% observed with combo vs. 9.7% with monotherapy). On | |||||||||||
efficacy, 1-year PFS of relatlimab/nivo (47.7%) was numerically lower to cross trial to | |||||||||||
CheckMate-067 comparison of nivo/ipi (50%). On safety, the combo demonstrated | |||||||||||
a significantly better safety profile cross trial (18.9% vs. 59%, respectively). At this | |||||||||||
year's ESMO Congress (Sept. 16-21), Bristol reported additional efficacy results. | |||||||||||
Prolonged benefit was observed with combination treatment vs. single agent nivo. | |||||||||||
The combination led to a longer treatment-free interval (TFI), as well as a reduction | |||||||||||
in risk of progression or death following the next line of therapy. Specifically, patients | |||||||||||
that received the doublet and discontinued the treatment (n = 167) experienced a | |||||||||||
longer TFI vs. single-agent nivolumab (n = 151): median TFI of 3.22 (range, 0.1-30.4) | |||||||||||
vs. 1.41 (range, 0.1-25.6), respectively. Relatlimab plus nivolumab also reduced the | |||||||||||
risk of progression following the next line of systemic therapy (PFS2). The median | |||||||||||
PFS2 in the doublet arm had not yet been reached while the single therapy arm was |
20.04 months. While we await overall survival (OS) data, we believe the positive combination broadly validates LAG-3 as a checkpoint target and continues to build the case for LAG-3 and for Immutep's eftilagimod. With a PDUFA data of March 19, 2022, LAG-3 appears to be on the road to becoming the third approved checkpoint.
Naureen Quibria, Ph.D. | Near-termcatalysts for Immutep. While multiple operational updates are expected |
(212) 895-3620 | (such as trial initiations and recruitment updates), we are watching for data readouts |
nquibria@maximgrp.com | on: |
SEE PAGES 3 - 4 FOR IMPORTANT DISCLOSURES AND DISCLAIMERS
Immutep Limited (IMMP)
- AIPAC final overall survival (OS) data - multicenter, placebo-controlled, randomized trial (N=227) of efti in combination with chemotherapy in HER2-/ HR+ metastatic breast cancer patients; final OS data is expected in 2H21.
- TACTI-002(KEYNOTE-798) - the ongoing Phase 2 study is evaluating efti with pembrolizumab in 1L non-small cell lung cancer (NSCLC), 2L in NSCLC in PDX-refractory patients, and 2L head and neck squamous cell carcinoma (HNSCC); potential update in 2H21.
Company overview: Immutep is a clinical-stage biotechnology company that is focused on developing LAG-3 both as an immune stimulator and an immune suppressor, for cancer and for autoimmune diseases, respectively. The company's lead product candidate is eftilagimod alpha (efti), a soluble LAG-3 fusion protein, that is being evaluated in combination with chemotherapy or immune therapy for multiple advanced cancers. The company also has licensing deals with large pharma for additional LAG-3 products: GSK'781 with GlaxoSmithKline (GSK - NR) and LAG525 with Novartis (NVS - NR).
Maxim Group LLC | 2 |
Immutep Limited (IMMP)
DISCLOSURES
Immutep Limited Rating History as of 09/16/2021
powered by: BlueMatrix
Buy:$4.00 | Buy:$2.00 | Buy:$4.00 | Buy:$8.00 | |||||||||||||||||||||||||||||||||||||||||
07/31/19 | 04/06/20 | 11/11/20 | 12/10/20 | |||||||||||||||||||||||||||||||||||||||||
$10 | ||||||||||||||||||||||||||||||||||||||||||||
$8 | ||||||||||||||||||||||||||||||||||||||||||||
$6 | ||||||||||||||||||||||||||||||||||||||||||||
$4 | ||||||||||||||||||||||||||||||||||||||||||||
$2 | ||||||||||||||||||||||||||||||||||||||||||||
$0 | ||||||||||||||||||||||||||||||||||||||||||||
Oct | 18 | Jan | 19 | Apr | 19 | Jul | 19 | Oct | 19 | Jan | 20 | Apr | 20 | Jul | 20 | Oct | 20 | Jan | 21 | Apr | 21 | Jul | 21 | |||||||||||||||||||||
Closing Price | Target Price | |||||||||||||||||||||||||||||||||||||||||||
Maxim Group LLC Ratings Distribution | As of: 09/19/21 | ||
% of Rating for which Firm | |||
% of Coverage | Provided Banking Services | ||
Universe with Rating | in the Last 12 months | ||
Buy | Fundamental metrics and/or identifiable catalysts exist such that we | 87% | 53% |
expect the stock to outperform its relevant index over the next 12 months. | |||
Hold | Fundamental metrics are currently at, or approaching, industry averages. | 13% | 44% |
Therefore, we expect this stock to neither outperform nor underperform | |||
its relevant index over the next 12 months. | |||
Sell | Fundamental metrics and/or identifiable catalysts exist such that we | 0% | 0% |
expect the stock to underperform its relevant index over the next 12 months.
*See valuation section for company specific relevant indices
I, Naureen Quibria, Ph.D., attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report.
The research analyst(s) primarily responsible for the preparation of this research report have received compensation based upon various factors, including the firm's total revenues, a portion of which is generated by investment banking activities.
Maxim Group makes a market in Immutep Limited
Maxim Group expects to receive or intends to seek compensation for investment banking services from Immutep Limited in the next
3 months.
IMMP: For Immutep, we use the BTK (Biotechnology Index) as the relevant index.
Valuation Methods
IMMP: We forecast sales for efti in metastatic breast cancer in 2025 (EU, US) and in 2027 (China), in non-small-cell lung cancer in 2025 (EU, US), and in head and neck in 2024 (EU, US). We assume royalty revenues for LAG525 in 2025 (EU, US) and for GSK'781 in 2027 (EU, US). We use a 30% discount rate and attribute equal weighting to our FCF, discounted EPS and SOTP to derive our price target.
Price Target and Investment Risks
IMMP: Aside from general market and other economic risks, risks particular to our price target and rating for Immutep include: (1) Development-To date, LAG-3 checkpoint modulators have not been approved; (2) Regulatory-The company's ongoing and future studies may not be sufficient to gain approval; (3) Commercial-The company lacks commercial infrastructure to support a launch if approved; (4) Financial-The company is not
Maxim Group LLC | 3 |
Immutep Limited (IMMP)
yet profitable and may need to raise additional capital to fund operations; (5) Collaborative-The company has ongoing collaborations with large pharmaceutical companies who could back out of the partnerships, setting back development on product lines and increasing costs; (6) Foreign exchange fluctuations as the company is domiciled in Australia; (7) High volatility of the company's stock price.
RISK RATINGS
Risk ratings take into account both fundamental criteria and price volatility.
Speculative - Fundamental Criteria:This is a risk rating assigned to early-stage companies with minimal to no revenues, lack of earnings, balance sheet concerns, and/or a short operating history. Accordingly, fundamental risk is expected to be significantly above the industry. Price Volatility:Because of the inherent fundamental criteria of the companies falling within this risk category, the price volatility is expected to be significant with the possibility that the investment could eventually be worthless. Speculative stocks may not be suitable for a significant class of individual investors.
High - Fundamental Criteria:This is a risk rating assigned to companies having below-average revenue and earnings visibility, negative cash
flow, and low market cap or public float. Accordingly, fundamental risk is expected to be above the industry. Price Volatility:The price volatility of companies falling within this category is expected to be above the industry. High-risk stocks may not be suitable for a significant class of individual investors.
Medium - Fundamental Criteria:This is a risk rating assigned to companies that may have average revenue and earnings visibility, positive cash flow, and is fairly liquid. Accordingly, both price volatility and fundamental risk are expected to approximate the industry average.
Low - Fundamental Criteria:This is a risk rating assigned to companies that may have above-average revenue and earnings visibility, positive cash flow, and is fairly liquid. Accordingly, both price volatility and fundamental risk are expected to be below the industry.
DISCLAIMERS
Some companies that Maxim Group LLC follows are emerging growth companies whose securities typically involve a higher degree of risk and more volatility than the securities of more established companies. The securities discussed in Maxim Group LLC research reports may not be suitable for some investors. Investors must make their own determination as to the appropriateness of an investment in any securities referred to herein, based on their specific investment objectives, financial status and risk tolerance.
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Immutep Ltd. published this content on 20 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 September 2021 18:31:01 UTC.